Harold Sackeim Mecta deposition video clips, page 2

The Awakening

This clip is an interesting explanation of why psychiatrists have apparently been unaware for 70 years that ECT can and does cause profound memory loss and cognitive damage. The reason? Because until a few years ago, the only persons who complained of severe memory loss also said it didn’t help them. It took finding some patients who experienced devastating memory loss who would also proclaim it “saved their life” before Harold Sackeim would listen.

Hey, I’m not the one who said it…Harold is. He’s the champion of the shock patient, at least in his own head. Maybe he needs to revisit the early years of Sackeimology, when his research revolved around self deception, the lies we tell ourselves.

Harold (call him doctor, damn you!) relates an interesting story, if true. He’s been known to make up statistics and a vignette or two. And he questioned whether or not the individuals on ect.org were really ECT patients. That’s called projection, Harold. Or deflection. You should have learned these terms when you studied Sackeimology.

The story takes place at an ECT donut course. (Shock docs and donuts are like cops and donuts.) One of the “very famous people” (that could really only be Abrams, Fink or Kellner, probably the Finkster) announced that profound memory loss just doesn’t happen. But our hero Harold asked the audience – all shock docs – if they’d encountered it. Two-thirds raised their hands. Oops. 70 years of denial down the drain.

It was almost a watershed moment, he says. The only thing missing was the heavens opening and the Angel Gabriel trumpeting the good news: Harold Sackeim is GOD, everyone. He’s your savior.

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FDA and ECT devices

This is the well-known story of how the FDA has been lobbied by the industry to change ECT devices from Class III to Class II. What’s interesting (and keeps popping up in Harold’s testimony) is that apparently the psych rights movement is having an impact on things. Despite his admitting that he speaks with the FDA regularly, and that the industry has lobbied the FDA for the change, Harold says the FDA is afraid to make a move.

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“I DO consider it.”

When asked if he discounts the many personal accounts of memory loss post-ECT, he responds that he does consider it.

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Electrical parameters

Harold discusses the parameters of ECT, cognitive side effects and Mecta machines.

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What they knew, when they knew

Is it necessary to inform patients of the risk of permanent, severe memory loss? Harold says it’s not in dispute…of course you tell them, and he always does. At least in the last three or four years…once they discovered it really happens. Before then, well, they kinda knew, but they just had no scientific evidence that it did, and the wrong kinds of people had been talking about it. So it’s not their fault because they didn’t know. They just didn’t know. Until a few years ago.

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Sackeim: “I got the field to do that”

Harold says the APA Task Force Report now says that ECT can cause profound memory loss. ECT patients have only been saying that for…hmmm, nearly SEVENTY YEARS!

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Memory and cognitive effects of ECT

Memory and cognitive effects of ECT: informing and assessing patients

Advances in Psychiatric Treatment (2006), vol. 12, 228 238

Harold Robertson & Robin Pryor

Abstract:

Over the past few years electroconvulsive therapy (ECT) has come under increased scrutiny in the UK, with the first systematic review of patients’ experiences and new national guidelines. Our aim in this article is to translate recent and sometimes confusing research and policy statements into practical guidance that benefits patients. We examined the evidence on the permanent memory and cognitive effects of ECT, with a focus on delineating their nature, understanding how ECT may cause them, informing prospective patients about them, and assessing their impact on former patients. We describe a simple and effective method for assessing retrograde amnesia. Data do not exist at this time to confirm the mechanisms by which ECT exerts its adverse effects, but clinicians should fully inform patients of the possible permanent adverse effects of the treatment, which include amnesia, memory disability and cognitive disability, and should provide follow-up testing using relevant instruments.

In January 2002, as part of a review of electroconvulsive therapy (ECT) undertaken by the UK’s Department of Health, the Service User Research Enterprise (SURE) published the first-ever systematic review of patients’ views on ECT (Service User Research Institute, 2002). The review encompassed several large-scale surveys by or of people who had received ECT in the UK (United Kingdom Advocacy Network, 1996; ECT Anonymous, 1999; Pedler, 2000). In April 2003, the National Institute for Clinical Excellence (now the National Institute for Health and Clinical Excellence, NICE) issued guidance on the use of ECT, and at the same time, the UK ECT Review Group published a review of its safety and efficacy (National Institute for Health and Clinical Excellence, 2003; UK ECT Review Group, 2003). The Royal College of Psychiatrists has established the ECT Accreditation Service and revised its guidelines for practitioners to take into account the NICE advice (Royal College of Psychiatrists, 2005).

Some of the conclusions to come out of the new work – in particular, that at least one-third of patients experience permanent amnesia (Service User Research Institute, 2002; Rose et al, 2003; Scott, 2005), that half of patients had not received an adequate explanation prior to treatment (Rose et al, 2003, 2005; Philpot et al, 2004) and that newer methods of ECT have not resulted in an appreciable decrease in adverse effects (UK ECT Review Group, 2003) – suggest that changes are overdue in both practice and policy.

The new evidence presents opportunities for improving clinical care in several areas: delineating the nature of ECT’s permanent adverse effects; developing adequate and relevant tools to assess patients; and providing consent that is fully informed.

Defining deficits

It is evident from a close reading of patient reports such as those documented by SURE that ‘memory’ is too simple a term to encompass the range of ECT’s permanent adverse effects, yet there has been almost no work done on improving terminology (Box 1). The confusion goes back to the first instrument specifically designed to assess people given ECT, the Squire Memory Questionnaire (SMQ; Squire et al, 1979). The SMQ was developed to distinguish between the cognitive impairments associated with depression and those caused by ECT. Although Squire and his colleagues believed that they had done this (Squire & Slater, 1983; Squire & Zouzounis, 1988), others have not used the test for its intended purpose, and it is hard to say whether the SMQ has muddied the water more than it has cleared it. Although often spoken of as if it measured a unitary entity ‘memory’, the SMQ actually encompasses multiple dimensions of cognition: attention, alertness, concentration, learning. It does not at all address the most common effect of ECT, which is variously called amnesia, retrograde amnesia or memory loss. By these terms is generally understood the obliteration of a specific time period in a person’s life.

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It is when ‘memory’ is used as a shorthand term for both retrograde amnesia and ongoing difficulties with memory function in the present that confusion ensues, a confusion that intensifies when the latter is sometimes called ‘anterograde amnesia’. Although most will understand anterograde amnesia to mean ongoing memory disability, this is not always the case. The US National Institute of Mental Health has defined anterograde amnesia as the inability to remember events that happened after ECT (National Institutes of Health, 1985) and the College’s new handbook (Royal College of Psychiatrists, 2005) appears to use it in the same way.

To confuse matters further, the term ‘short-term memory loss’ is sometimes used as a synonym for anterograde amnesia. Short term to some will mean temporary, to others it will be seen as a description of the type of memory that is affected – the ability to retain information for a short period, or working memory (Baddeley & Hitch, 1974) – which says nothing about its longevity. The term ‘temporary’ rather than ‘short-term’ should always be used to refer to effects that resolve, but even then it should be used with caution because neuropsychology recognises that transient impairment of cognitive function may have residual permanent effects. ‘Dysfunction’ or ‘disability’ should be used rather than ‘loss’ (which implies a one-time event) to refer to ongoing difficulties with memory ability and cognition.

If the term anterograde amnesia must be used, it should be clearly defined as difficulties with memory in daily life, and examples given (Box 2).

Inevitably, memory overlaps with and subsumes other cognitive functions, such as learning and attention as well as overall intelligence. When individuals who have had ECT report ongoing memory disability, it is necessary for a clinician
trained in neuropsychological evaluation to tease out the roles played by attention, concentration, overall slowed mental processing and deficits of executive function such as inability to shift mental set. The ECT psychiatrist and treatment team may not be trained in neuropsychological evaluation, since outside of research settings it is not routinely performed on people who have had ECT. When it is, it is usually initiated by the patient, not the doctor. Because of this, the treating psychiatrist may fear personal liability and thus be unwilling to attribute deficits to ECT.

It has long been known that ECT can produce deficits in non-memory-related cognitive function (Calev, 1994). However, long-term studies comparing controls and people who have had ECT to determine when and if non-memory cognitive function normalises after ECT have not been done. A comprehensive battery of neuropsychological tests carried out on individuals who had had ECT between 9 months and 30 years previously revealed impairment on a range of measures, even after controlling for the effects of illness and medication (Freeman et al, 1980).

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Despite recommendations that psychiatrists inform patients of non-memory cognitive after- effects (Calev, 1994) and warn them that ‘they are not going to function well on more tasks than they anticipate’ (Calev et al, 1995), patients are still routinely not informed about these effects; there is no mention of them in the recommended consent forms of the American Psychiatric Association (APA; 2001), the Royal College of Psychiatrists (2005: Appendix 1V) or the manufacturers of ECT equipment. This may contribute to the consistent findings (Rose et al, 2003, 2005; Philpot et al, 2004) that half of people given ECT say they did not receive an adequate explanation of the treatment.

The current APA consent forms not only contain no warnings about adverse effects on cognition, but advise that ‘Most patients report that memory is actually improved by ECT’ (American Psychiatric Association, 2001). This statement is contradicted by all service-user research as well as the findings of SURE (2002) and NICE (2003); indeed, Scott (2005) remarked that NICE took ‘special note of the evidence from users that cognitive impairment after ECT often outweighed their perception of any benefit from it’.

Is it depression?

If the task of assessing amnesia, memory disability and cognitive deficits is left to a patient’s treating psychiatrist, there may be a tendency to attribute all deficits, without evaluation, to depression, even when the patient has fully recovered. The APA guidelines state that

‘Patients with the greatest symptomatic benefit from
ECT typically report the greatest improvement in
subjective evaluations of memory. Thus, when patients
report subjective memory impairment after ECT, their
mood as well as their cognition should be assessed’
(American Psychiatric Association, 2001: p. 72).

It seems that this statement is based on SMQ scores from six studies: Pettinati & Rosenberg, 1984; Weiner et al, 1986; Mattes et al, 1990; Sackeim et al, 1993 and Coleman et al, 1996, which involved the same patients; and Sackeim et al, 2000. On average, patients reported improvement in cognitive functions assessed by the SMQ within 1 week of ECT. However, the following should be taken into account: first, the improvement was relative only to immediate pre-ECT status, not baseline, thus in fact reflecting a net impairment; and second, objective testing revealed that the patients were in fact cognitively impaired post-ECT. There are other studies in which patients reported impairment post- ECT on the SMQ (Squire et al, 1979; Squire & Slater, 1983; Squire & Zouzounis, 1988). To the extent that a handful of studies support a claim of correlation between memory and cognitive self-rating and mood during or immediately after ECT, there might be a correlation between relatively improved memory self-rating and improved mood. There is no evidence of a correlation between impaired memory/cognition after ECT and impaired mood, much less a causal relationship. The problem of premature assessment There are many reasons why hospitalised patients who have received ECT might overestimate their abilities. After each treatment they experience acute organic brain syndrome (Sackeim, 1986). In hospital, they are not exposed to even minimally taxing actions such as shopping and driving. There are no environmental cues as to what they are expected to know and remember in their roles outside the hospital. In a few days or even weeks, patients cannot gain enough experience of using their minds and memories to accurately assess their altered capacities (Weiner et al, 1986; Coleman et al, 1996; Donahue, 2000). In the longer term, i.e. 2-6 months, patients who initially rated their memory and cognition as improved, experience and accurately report impairment (Weiner et al, 1986; Coleman et al, 1996).

More recent work using the SMQ suggests that, in the short term as well, patient ratings of memory function are negative and are correlated with the results of objective tests, even when controlling for the level of depression. These researchers say that patient reports of memory impairment ‘must not be dismissed as being depressive complaints only’ (Schulze-Rauschenbach et al, 2005).

Differentiating the effects of ECT

Although terms such as memory loss are often used interchangeably by clinicians to describe the temporary effects of depression on cognition (especially attention) and the long-lasting effects of ECT on a range of cognitive functions, this confusion is unnecessary and could be avoided. The effects of ECT are quantitatively and qualitatively different from those of depression (Squire et al, 1979) and researchers have consistently distinguished between them (Cronholm & Ottoson, 1963; Squire et al, 1979; Squire & Slater, 1983; Pettinati & Rosenberg, 1984; Squire & Zouzounis, 1988). Numerous controlled studies show that individuals who are depressed but have not had ECT do not suffer amnesia (Janis, 1950;

Weiner et all 1986). People who have experienced the effects of both depression and ECT rarely mistake one for the other (Food and Drug Administration, 1982; Donahue, 2000): ECT’s effects are different and worse, they occur only after ECT and they persist in the absence of depression and drugs.

Possible mechanisms of action

How might ECT cause permanent amnesia and memory and cognitive disability? There are several theories (Box 3). One is that memory is affected because the applied electrical current is densest in the medial temporal area structures associated with memory, including the hippocampus; these areas have low seizure thresholds. However, this has not been studied directly (Calev, 1994).

Other theories focus on ECT’s effects on brain metabolism and neurochemistry: breach of the blood-brain barrier and increased cerebral blood pressure (Bolwig et al, 1977; Taylor et al, 1985); regional increases in T2 relaxation times (Diehl et a!, 1994); disturbance of the long-term potentiation mechanism (Sackeim, 2000; Rami-Gonzalez et al, 2001); excessive release of excitatory amino acids and activation of their receptors (Chamberlin & Tsai, 1998; Rami-Gonzalez et all 2001), and decreased cholinergic transmission (Khan et al, 1993; Rami- Gonzalez et al, 2001). Even temporary alterations in any of these may have permanent effects on the brain.

Since ECT affects both temporal and frontal lobes, it is logical that its effects would not be limited to amnesia, but would involve both memory and non-memory neuropsychological functions (Calev et al, 1995). Sackeim (2000) hypothesises that the traditional view that amnesia results from damage to medial temporal lobe structures alone may be wrong, since it is known both that frontal lobe damage can result in amnesia as extensive as that seen after ECT and that ECT exerts its most profound effects on the prefrontal cortex.

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If this hypothesis holds, then frontal functions must be affected as well as memory. Simply because there has been very little investigation of ECT’s effects on these functions, doctors should not be sanguine as to lack of permanent effects. Absence of evidence is not evidence of absence. In particular, Sackeim (2000) points to the lack of formal research on ECT’s effects on the executive functions of the prefrontal cortex: working memory (holding onto information in the service of a range of cognitive functions), logical reasoning and abstraction, shifting of mental set, problem-solving, planning and organising. These are ‘fundamental to organising one’s life and controlling behavior, yet there has been little investigation of the impact of ECT’ (Sackeim, 2000).

Three trials, two controlled and one small and uncontrolled, support the theory of frontal lobe involvement in functional impairment, although assessments were carried out only during or immediately after ECT (Neylan et al, 2001; Rami- Gonzalez et al, 2003; Schulze-Rauschenbach et al, 2005).

A generation ago, one researcher, reviewing the literature on ECT experimentation, wrote that the ease of its administration has resulted in its widespread use

‘without the usual background information customarily thought appropriate for most treatment modalities o this is undoubtedly the case because of the clinically observed changes in affect and behavior that result from such treatment. While such behavioral observations are certainly fruitful, such a model should be reversed to allow behavioral inferences to the possible effects on neocortical structures of such a procedure’ (Goldstein et al, 1977).


The evidence base

In the absence of long-term follow-up studies over the past two decades, the best available evidence for the permanent effects of ECT on memory ability and cognition has been generated by former patients. This has most often taken the form of patient-designed survey instruments, which ask specifically about cognition. Of the groups whose findings were incorporated into the SURE systematic review, one found that 65% of people who had had ECT reported impaired organisational skills (ECT Anonymous, 1999). Another found that one-third had difficulty concentrating, and 15% reported loss of reasoning ability (Pedler, 2001). A third asked people whether they had experienced a loss of intelligence ‘soon after the treatment’, and about 40% answered affirmatively (they were not asked whether the loss persisted) (Philpot et al, 2004). However, former patients have publicly testified that ECT can result in a very significant (>30 point) permanent decrement in IQ score (Food and Drug Administration, 1982; Andre, 2001; Cott, 2005: p. 5) and have documented the claims by extensive neuropsychological evaluation.

Although surveys and case reports are not rigorous controlled trials, in the absence of such trials conducted months or years after ECT, they provide a basis for inferences as to the treatment’s permanent adverse effects and possible mechanisms of action.

What’s wrong with the way patients have been assessed?

Claims that ECT does not have permanent adverse effects on memory and cognitive ability have been based on extremely gross measures of mental function such as the Mini-Mental State Examination (MMSE; Folstein et al, 1975) and other dementia screening scales (Stoudemire et al, 1993; Sackeim, 2000; McCall et al, 2004). But if ECT had produced wholesale dementia on a scale gross enough to be detected by these tests, it would have been abandoned decades ago.

Researchers have used very simple, brief measures to assess patients – typically, highly structured tests of verbal learning involving familiar material. Examples include the Auditory Verbal Learning Test (AVLT; Rey, 1964) and various forms of paired associates, with very short retention intervals. But there is no evidence that ECT interferes with well- established skills such as vocabulary or with short recall periods (Squire & Chace, 1975; Zervas & Jandorf, 1993).

Even people with severe brain injury or lobotomy can perform well on simple tests of overlearned verbal material that require culturally common information, for example the Wechsler Memory Scale. Highly motivated and concerned ECT patients are even more likely to do well on these tests. However, clinicians who conclude from this that there is ‘no memory loss’ have not measured memory loss at all, and certainly not the type of memory and cognitive disability that people can experience after ECT (National Institute for Clinical Excellence, 2003).

Collectively, the comments of people who have had ECT indicate loss of complex skills that underlie real-world roles such as student, professor, nurse or physicist, and often inability to return to those roles post-ECT (Box 4).

The sensitivity of the tests used after ECT depends largely on whether and how well they reflect actual cognitive demands of the type placed on ex-patients. Researchers have assured patients that ECT has no permanent adverse effects on the basis of the assumption that these demands will be minimal (McCall et al, 2004). But this assumption has never been tested, and patient reports warn against it. The ECT patient population includes people who are in the prime of life, highly educated and involved in demanding professions, and who can be very articulate in describing their deficits. If simple standardised tests cannot detect these deficits, the challenge is not to dismiss their comments but to find or devise more appropriate tests.

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The Autobiographical Memory Interview

Weiner et al (1986) and Sackeim and his colleagues (Coleman et al, 1996; Sackeim et al, 2000) have attempted to measure amnesia with an unvalidated instrument of their own design, known as the (Columbia University) Autobiographical Memory Interview. This test is insensitive to ECT-induced amnesia in two related ways: it measures very old information whereas ECT amnesia is known to be densest for more recent memory; and as many as 60% of the 200-300 test items involve overlearned and highly rehearsed facts – grandparents’ names, telephone numbers of close relatives, etc. – which are not likely to be erased by ECT. The overlearned and the old information may overlap (as in questions such as ‘What is your address’) or it may not, but in either case confounding the testing with these factors will unnecessarily result in an underestimate of the extent of retrograde amnesia.

Furthermore, the Autobiographical Memory Interview assumes that amnesia is limited to events that took place within the 12 months prior to ECT and does not attempt to assess amnesia that is not limited to that time period. However, only about 20% of the questions ask specifically about that year; the rest ask about overlearned personal information (What are your parents’ names? What are the rooms in your house?) or about events that have ‘ever’ happened to patients or their families.

Thus, it is remarkable that even as insensitive an instrument as this has shown extensive permanent retrograde amnesia measured at 2 months (Cole- man et al, 1996) and 6 months (Weiner et al, 1986) after ECT.

Assessment of amnesia

Routine neuropsychological tests are unhelpful in attempting to assess retrograde amnesia (Rose et al, 2003). Squire & Slater (1983) attempted to measure amnesia by asking people who had had ECT to make a time line showing the amount of life lost. The accu- racy of this depends, of course, on the patients’ ability to assess the extent of their amnesia, which can take many years, as they can only discover what they have forgotten when prompted by others to remember it. If asked soon after ECT, they are very likely to under- estimate the extent of retrograde amnesia.

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Because the information stored in memory is unique to each individual, standardised questionnaires or checklists may prove insensitive to amnesia even when the patient can describe or demonstrate it. Janis (1950) interviewed patients before and 1 month after ECT. He suggested general topics but let the patients speak at length. After ECT, he attempted to elicit the same information, but could not. For each individual he could count 10-20 significant life experiences that had been erased that were not limited to the period immediately before the treatment. Even when he prompted patients to recount events they had described in great detail before treatment, they could neither recall nor recognise them. One year after ECT, the amnesias remained stable. The same interviews were given to controls matched in all ways: age, gender, education, duration of hospitalisation, type and duration of mental disorder; the controls, who had not had ECT, had no amnesia.

The Janis test (Janis, 1950) can be done easily and cost-effectively even by those with no special research training. SURE (2002) in particular calls for the replication of this study, as have others over the years. But it has not yet been done.

Assessment of memory and cognitive ability

Tests of memory and cognitive ability must assess a range of functions, because ECT impairment may vary not only between individuals (Goldstein et al, 1977) but within individuals when they undergo more than one course of treatment. Simple tests of rote verbal learning or the memory sub-tests of the Wechsler are not sufficient, since ECT (if the amnesia is not catastrophic) spares vocabulary, overall wealth of knowledge and overlearned verbal skills. Patients who have had ECT should be evaluated with the type of neuropsychological batteries that would be used for patients with a known or suspected history of brain injury. These should include tests of non- verbal and visuospatial memory and reasoning such as those listed in Box 5.

If there are constraints of time and finances, tests should be tailored to the individual’s deficits, which can be identified by narrative self-report and by rating scales such as the Cognitive Failures Questionnaire (Broadbent et al, 1982).
When should patients be tested?

If there is to be baseline testing, compensation must be made to account for the difference between the patient’s true memory and cognitive capacity and the performance when preoccupied by depression, medicated or hospitalised. If such compensation is not made, all a return to ‘baseline’ function after ECT would show would be that ECT’s effects are roughly equal to – although not necessarily the same as – those of depression (Calev et al, 1995).

A better estimation of pre-ECT capacity would be the patient’s history and normal functioning at school, work or in some other capacity. Many patients, at least in the USA, will have had an IQ test, which can be used for comparison with post- ECT scores.

Patients cannot be meaningfully evaluated in hospital during or soon after ECT. Neither self- reports nor crude memory tests may be reliable (Cronholm & Ottoson, 1963). A patient may do well on the MMSE or counting serial sevens but may not know that her friend visited her the day before – and will not know she doesn’t know. Having had no reason theretofore not to trust her memory, and not having been warned to expect severe dysfunction, she will adamantly insist that her memory cannot be faulty. It is not the psychological defence mechanism of denial, nor is it only the acute organic brain syndrome which occurs with ECT, that causes this genuine unawareness. Most patients have never before experienced a day in their life when they did not know what they ate for dinner or who they had seen or what they had read the day before. They do not even know that this is possible, let alone that it is happening to them.

The ECT Accreditation Service (2005) recommends that patients should be interviewed 3 and 6 months after ECT. But at 3 months, they may not have recovered the ability to hold on to day-to-day memories (they may still be within the period of anterograde amnesia, estimated by the US National Institutes of Health (1985) to average 2 months). We propose that follow-up should be no sooner than 6 months. One year allows for optimal stabilisation of permanent cognitive deficits and better assessment of retrograde amnesia.

The Service User Research Enterprise (2002) has called for a research study with ‘long followup because losses of memory prior to ECT may only become apparent after a long interval’, as have Greenhalgh et al (2005: p. 78).

What should patients be told?

Amnesia

The clinician who tells her patients that there is a lack of research on the permanent adverse effects of ECT will certainly be on solid ground; however, this is unlikely to help patients in making a potentially life-altering decision. The best she can do is present her patients with what is known (and not known) and encourage them to assess the risk in light of their personal situation.

Thus, patients can be told that permanent amnesia is one of the ‘common’ (Sackeim, 2000) or ‘serious/ frequently occurring’ (Royal College of Psychiatrists, 2005: p. 207) effects of ECT and that it affects at least one-third of patients (Service User Research Institute, 2002; Rose et al, 2003). Such amnesia may be presented as having multiple dimensions: the amount of life lost, the temporal gradient, the nature of what is lost, and the effect of the memory erasure on the individual’s life.

The amount of life lost to amnesia cannot be predicted; patients should be warned that it has been known to extend to 10-20 years (Pedler, 2001; Service User Research Enterprise, 2002). It should be made clear that amnesia is not limited to information about discrete events or to facts that are easily regained, such as dates and telephone numbers, but that it encompasses all thoughts, feelings, personal interactions and relationships, learning and skills associated with the erased time period, and thus there is no simple or easy way to recapture what is lost. Since the temporal gradient of ECT amnesia is the opposite of normal forgetting, patients should be warned that the most recent months or years will be most affected. When amnesia is permanent it has profound, rarely positive, effects on all aspects of the patient’s subsequent life. For many people the effects of permanent amnesia and/or memory and cognitive disability negate any benefit sustained from ECT (National Institute for Clinical Excellence, 2003).

The College now advises psychiatrists to discuss the topic of retrograde amnesia carefully (Royal College of Psychiatrists, 2005: p. 7). But profound and sudden retrograde amnesia has no parallel in ordinary human experience. Doctors cannot be expected to understand the myriad ways in which permanent amnesia can disrupt one’s life. For this reason, prospective patients should be encouraged to speak with, or read accounts written by, people who have experienced amnesia. Such accounts are contained within the above-mentioned reports of SURE, NICE and MIND (Pedler, 2001), and are widely available in print (e.g. Donahue, 2000) and through online forums, e.g. http://www. ect.org) where prospective patients and families can sometimes ask questions directly of former patients.

Cognitive impairment

The Royal College of Psychiatrists (2005: p. 19) and NICE (2003) advise that the potential for cognitive impairment be highlighted during the consent process. Patients should be clearly told that ECT may have serious and permanent effects on both memory ability and non-memory cognition. These are best described in everyday terms: ‘the ability to plan and organise and get things done’ rather than ‘executive function’.

Intact memory and intelligence are highly prized in our culture. The more valuable a possession, the more important it is to know about even a small chance that it might be permanently lost. Even if the answer to how often IQ is permanently lowered is ‘We don’t know’, that is a material fact to be weighed by the patient. As individuals, patients vary greatly in the demands placed on their intellect and the potential consequences of permanent impairment. The decision to agree to ECT is theirs; the duty to inform, their physician’s.

Conclusions

Evaluation and re-evaluation of ECT’s risks and benefits by SURE, NICE and the Royal College of Psychiatrists, and the growing recognition of the extent and importance of research by and involving people who have experienced ECT, as well as increased interest in qualitative data, should lead to improvement in both patient care and research. In light of alarming findings that 50% of patients report receiving inadequate warnings of the potential side- effects of ECT, informed consent practices need to be revised. In particular, prospective patients should be warned of the significant risk of permanent amnesia and the possibility of permanent memory and cognitive disability. Research to adequately assess the nature and longevity of these effects should be undertaken, ‘incorporating patients’ perspectives on the impact of ECT into future RCTs’ (Greenhalgh et al, 2005: p. 78). By all accounts this is long overdue.

Declaration of interest
None.

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For a commentary on this article see pp. 237-238, this issue.

Harold Robertson (148 Beach 94th St, Suite 6, 3rd Fl., Queens, NY 11693, USA. Email: robertson.harold@gmail.com) is the director of a not-for-profit charitable foundation in New York focusing on the underserved patient population. His interest in psychiatric research, in particular research into the use of electroconvulsive therapy, has brought him into contact with others with similar interests across the globe for the past 20 years. Robin Pryor is a psychologist who has held a private practice in New York, NY, for 30 years. His particular interests are the history of psychiatry and first-person narratives of mental health service users. He writes and lectures on these topics.

Beyond “anecdotal” evidence: Poster Session at NIMH Conference

This was a poster session presented at the annual NIMH Conference by Linda Andre and Juli Lawrence. Note: graphics are clickable for larger views.

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Beyond “anecdotal” evidence:

The contribution of ECT survivors to research on the permanent effects of ECT on memory, memory ability and cognition

Authors:

Linda Andre
Juli Lawrence

2002

Statement of the Problem:

Evidence from ECT survivors has been dismissed as “anecdotal.”

Such evidence exists in many forums: in the popular press, in literature, in public testimony before legislatures, on the internet, in the archives of the Food and Drug Administration—but almost never in the published medical literature. Thus, this evidence has been almost entirely ignored by paid professional ECT researchers.

The discounting of the writings and testimony of ECT survivors has led to a “knowledge gap” in ECT research. The enormous body of knowledge of those with direct knowledge of the nature and extent of ECT’s permanent effects has been discounted by professional researchers. Professionals have attempted to study these effects without input from those directly affected. They have not been successful.

In an attempt to close this knowledge gap, survivor researchers have designed and instrumented our own research projects to investigate the permanent effects of ECT on memory, memory ability, and cognition.

There is a great disparity between the results obtained by professionals and those obtained by survivors.

Method:

We examine the dominant existing professional published research in comparison with four survivor-designed studies and attempt to account for the disparities.

Though we surveyed research from the 1940s to the present, we focus here on NIMH-funded research of the past 25 years. Although some studies from the 1940s and 50s stand as unsurpassed examples of sound research—especially the famous Janis study which has prompted calls for replication to this day—most of the earlier studies are characterized by the same methods, assumptions, and flaws as the later work.

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Survey of the professional literature:

There have been only two major NIMH grants to study memory.
MH24600: Memory as Affected by Disease, Injury, and ECT
Principal Investigator: Larry Squire

This grant was not primarily or exclusively designed to study the effects of ECT; the topic of study is memory loss in general.

• Used a self-designed instrument, the Squire Memory Questionnaire, designed to distinguish the effects of depression on memory and cognition from the effects of ECT. It was not designed to investigate the permanent effects on ECT on memory and cognition by comparing individuals who had ECT with their own baselines or with normal matched controls. Also, the questionnaire measures multiple aspects of cognition, not only memory or memory ability.

• Used low sensitivity instruments to assess memory ability (i.e., word lists remembered over a very short interval; remembering names of TV shows)

• Findings and conclusions often contradictory.

• A study that followed patients for six to nine months found the majority reported impaired memory ability due to ECT. (Squire and Chace, 1975)

• A study that followed patients for three years found that the majority (58%) reported impaired memory ability due to ECT. Patients also reported an average eight month period of amnesia. (Squire and Slater, 1983)

“Certain empirical questions about ECT that seem at first glance rather simple to answer by experiment are still widely debated. Does ECT permanently impair memory?” (1986)

“Information about recent events can be lost for a long time, possibly permanently, after ECT.” (1986)

“One way of understanding how such complaints could occur long after ECT is to suppose that they are based on the experience of amnesia initially associated with ECT.”

“There is no good evidence that new learning ability is still deficient six months after treatment.” (1986 Consensus)

“The possibility cannot be ruled out that more sensitive testing methods will some day reveal a greater degree of permanent memory loss.”

MH35636: Affective and Cognitive Consequences of ECT
Principal investigator: Harold Sackeim, PhD

• First awarded in 1981; renewed through 2010; funded approximately $300,000 per year for a total of more than six million dollars

• Principal investigator’s longterm financial and career conflict of interest make this work scientifically invalid.

• Beginning around 1982, Sackeim began working for ECT device manufacturer Mecta as a consultant, designing their devices including the SR-1 and SR-2. He also received grant money directly from Mecta. His financial interest in Mecta has never been disclosed to NIMH as required by federal law.

• Instead of studying memory and cognition directly, the work has focused on a comparison of different ECT techniques.
• Most of these studies follow patients no longer than two months. (This research team claims that all patients are followed up at six months and one year, but the results of these followups aren’t published.)

• Amnesia is assessed using a self-designed, unvalidated instrument, the Autobiographical Memory Inventory, designed without input from survivors. Survivor researchers estimate that at least 60% of the items are insensitive to ECT’s stereotypical effects (for example, they measure very old, overlearned information which is almost never forgotten after ECT).

• Cognition is assessed by gross instruments such as the MMSE. Memory ability is assessed by simple tests such as paired words. (This research team claims that more extensive neuropsychological testing—some of which would be relevant to ECT’s effects—is done on all patients before and after ECT, but the results of these tests have not been published.)

• Much of the grant has been spent selectively reviewing existing research rather than doing experiments. For example, rather than directly design an experiment to test whether ECT causes brain damage, the grantees chose to write a review of some of the existing experiments.

CONCLUSIONS:

After more than 20 years and more than ten million dollars spent on one grant alone, basic research on the permanent effects of ECT on memory, memory ability, and cognition is lacking. By the principal investigator’s own admission, there is no data and there are no answers to the most basic questions about ECT’s effects on memory.

“Prospective patients, family members, and the public often want to know the frequency with which patients report substantial memory impairment following ECT. While we believe that such reports are infrequent, there is little objective evidence to support this judgment or even to broadly estimate base rates.” editorial

“There is no evidence that ECT results in impairments of executive functions (e.g. the capacity to shift mental sets), abstract reasoning, creativity, semantic memory, implicit memory, or skill acquisition and retention.” APA

“No study has documented anterograde amnestic effects of ECT more than a few weeks following the ECT course.” APA

“A very rare number of patients may experience marked retrograde amnesia as a result of ECT. There is no firm estimate on this incidence, but my estimate would be on the order of 1 in 500 patients.” (statement—May)

“All of the available information, from scores of studies, indicates that this deficit (anterograde memory loss) disappears within days to a few weeks following the end of ECT.”(statement—May)

“I’ve never seen a case where there has been permanent effect of ECT on anterograde amnesia. And I invite anyone in the country who believes ECT’s had a deleterious effect on their cognition to come in for evaluation.” (May testimony)

Survey of the survivor literature:

Because of the enormous gaps in ECT research, survivors have undertaken research projects on their own to reflect the variety of experiences. The results of these studies widely challenge the results of the professional literature.

The following is a representative, but not exhaustive, listing of survivor-designed and implemented research.

Committee for Truth in Psychiatry ECT Survey, 1990

52 survivors who reported that they had experienced permanent amnesia and reported that they had not been warned about the adverse effects of ECT were asked about the nature of these effects, using a questionnaire adapted from a standard form used to assess brain injury. They were asked about thirteen common symptoms of brain injury, and asked whether they experienced each in the acute period (the first year after ECT) and in the long term.

All respondents indicated suffering from at least some of these symptoms since ECT, both short-term and long-term. Half of the respondents checked nearly all items in both time periods:

  • general loss of memory ability;
  • forgetfulness or absentmindedness
  • language impairment (not being able to think of a word, or forgetting what one intended to say)
  • difficulty in reading comprehension
  • not “getting the point” of jokes, stories, movies, etc.
  • forgetting new information abnormally rapidly
  • impaired sense of direction
  • difficulty concentrating
  • difficulty with spatial relations
  • loss of manual skill
  • other loss of familiar skills

The average number of years since ECT was 23. The average age at ECT was 24.

They were then asked about the degree to which they had been able to compensate for these deficits, and whether they found them disabling.

Only one-fourth of the respondents felt they had been able to compensate. They further reported that it had taken them anywhere from 8 to 43 years to reach the point where they were able to compensate for their deficits..

Two-thirds were unemployed, reporting that they had been employed prior to ECT and unemployed as a result of it.

90% said they still needed help in coping with enduring cognitive deficits.

“I think that the residual effects from ECT certainly slowed my ability to do the thinking, concentration, and memory necessary to do my school work…and thus added years to my achieving graduation from college.”

“There was no acknowledgment of any damage so no help was offered.”

“Neuropsychological evaluation showed low IQ, cognitive difficulties”

“I’m OK with multiple choice tests but can’t remember enough to do essays.”

“Retired on Disability, though an associate professor with lifetime tenure. Was doing PhD in Physics.”

“Before ECT I knew my way around town as well as I knew my way around my own house. Now my sense of direction is horrible. I’m always getting lost.”

“43 years to get back to almost as good as before.”

“I am a great deal brighter than average—so professionals do not believe I suffer any losses from ECT. I was not tested before ECT, only after!”

VOICES, 1996

Questionnaires were distributed via online newsgroups and email lists of psychiatric consumer/survivors. 41 respondents participated in the study. 83 percent reported feeling their long-term memory had been affected. This ranged from loss of certain events in their lives, to the inability to remember family members, and in some cases, up to 20 years of memories were erased. Only 17% felt that their long-term memory had not been adversely affected.

“The worst thing that ever happened to me…”
“ECT destroyed my family…”
“Doctor claimed memory problems would vanish in two weeks…”

Of females, 82.6% said long-term memory was affected, and among males, 83.3% reported problems.

“I can’t remember my 20-year Marine Corps career…or daughter’s birth or childhood…”

Short-term memory appears to have been affected slightly less, or the effects were temporary. 63.4% reported problems with short-term memory loss. 12% said they had no problems at all with short-term memory loss. And 22% said that short-term memory loss was either temporary or minor.

“I couldn’t remember people’s names, but it gradually came back…with some prompting…”

Half of all respondents reported that they were given no information about ECT and its effects, other than to be told it was effective. The other half were given information in the way of video tapes, pamphlets, books, and detailed discussions with their physician or nurse. Of those, however, several reported that they wish they had been given more accurate information concerning memory loss and other adverse effects.

“I did have detailed discussions with my doctors before the treatment, but I just couldn’t realize how bad the memory loss was going to be. If I had, I’m not sure I would have taken the treatments…”

ECT Anonymous, 1999

ECT Anonymous, located in the United Kingdom, surveyed 200 ECT survivors. 82 percent of respondents reported a loss of past memories, ranging from slightly (8 percent), moderately (33 percent) and severely (41 percent). 84 percent said they had impaired present memory ability, and 85 percent reported difficulties with concentration after having ECT.

MIND, 2001

In early 2001, the UK mental health charity MIND sent out over 6,000 copies of its detailed questionnaire regarding ECT use. 418 replies were received.

Key findings:

  • Almost three quarters (73%) of the total sample and almost two thirds (60.5%) of those given ECT most recently were not, as far as they remember, given any information about possible side effects.
  • Of those consenting to treatment in the last two years, 48% received, as far as they remember, no information about how the treatment would work and 44.5% no information about possible side effects.
  • 84% of respondents said that they had experienced unwanted side effects as a result of having ECT.
  • 40.5% reported permanent loss of past memories and 36% permanent difficulty in concentrating.
  • Respondents from black and minority ethnic communities were more likely to be detained under the Mental Health Act and to have received ECT without consent. They reported a more negative view of ECT than the overall sample with 50% finding it unhelpful, damaging or severely damaging in the short-term and 72% in the long-term.

“If I had known I had the right to refuse I would have done so. My understanding was that I had no choice in the matter and that they could do it by force.”

“Was told by consultant ‘best thing since sliced bread’, ‘be well in no time’. When went wrong, ‘this was the first time this had happened’.”

“Possible side effects were downplayed and only lightly touched upon.”

“I was given no information at all”

Published case studies

The individual case study is an important and necessary method of collecting evidence, since it allows the nature and extent of amnesia, memory disability, and memory loss to be described in detail impossible to obtain in-group studies. Consistency in individual case studies illustrates that ECT’s permanent effects have not changed over the years.

As Empty As Eve, by Berton Roueche; first published in the New Yorker, September 9, 1974; reprinted in The Medical Detectives, 1981

“There weren’t just gaps in my memory. There were oceans and oceans of blankness. And yet there seemed to be kind of a pattern. My childhood recollections were as strong as ever. The fog of amnesia increased as I came forward in time. The events of the past several years were the blurriest and the blankest. Another area that didn’t seem to be affected was ingrained habits—repetitive acts and procedures. I mean, I hadn’t lost my command of the English language. I still knew the multiplication tables…But worst of all my problems was that I couldn’t seem to retain. I couldn’t hang on to my relearning. Or only a part of it. The rest kept sliding away again.”

Electroconvulsive Therapy and Memory Loss: A Personal Journey, by Anne Donahue; The Journal of ECT, June 2000.

“My long-term memory deficits far exceed anything my doctors anticipated, I was advised about, or that are validated by research. To the contrary, either I am one in a thousand, a complete anomaly, to be able to document memory loss still remaining after 3 years and extending as far back as occurrences eight to nine years ago, or the profession in general, after all these years of treatment with ECT, has still failed to identify and come to terms with the true potential risks.”

Further evidence for permanent memory and cognitive impairment is found in the neuropsychological evaluations (standardized batteries of tests for brain damage, taking place over two or more days) obtained by individual survivors at their own expense; many of these are collected in the archives of the Food and Drug Administration, Docket #82P-0316.

SUMMARY of survivor findings:

  • Amnesia (retrograde memory loss) occurs in a majority of ECT survivors. Commonly, the loss encompasses years prior to ECT.
  • Memory disability (anterograde memory loss) is common and does not resolve after ECT.
  • When tested long after ECT, survivors experience cognitive deficits.
  • Each survivor has her pre-ECT self as a perfectly matched control subject, eliminating confusion as to etiology of deficits.
  • More research is needed using extensive batteries of neuropsychological tests such as those used to detect brain damage. From the preliminary data gathered by survivors, a characteristic pattern of ECT damage has emerged. While survivors may do well on simple tests such as paired words or the Mini Mental Status Exam, more comprehensive standard neuropsychological batteries reveal deficits in higher mental functions such as flexibility, shifting cognitive set, abstract and analytical thinking, and executive function. Loss of measured general intelligence (IQ) tends to be highly significant—30-40 points.
  • Survivors have absolutely no difficulty distinguishing normal memory failures from those caused by ECT. ECT amnesia and memory disability has little in common with normal memory fallibility, age-related disability, or problems associated with mental illness.

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Discussion

Published medical literature research:

A small and exclusive playing field: a handful of research teams dominate grant funding.

The only available NIMH grant to investigate memory is tarnished by financial and other conflicts of interest; since this grant is renewed indefinitely, there is little opportunity for researchers outside the ECT industry to obtain funding.

Rarely follows patients as long as six months; almost never longer

Most studies look only at the short-term effects (from during ECT to a few days or weeks after)

Sample sizes very small in general (>50)

Self-designed memory instruments designed without input from survivors, largely insensitive to stereotypical ECT amnesia, memory disability, and cognitive disability

Rarely directly study the effects of ECT on memory, memory ability, and cognition. Instead, studies compare persons who had different types of ECT with each other, rather than with their own baselines or normal controls, resulting in an underestimate of memory/cognitive damage.

Often use no or inappropriate controls

Subjects do not reflect true diversity of ECT patient population: all treated at the same hospital, with the same doctor, at the same time, usually with same machine and technique

Because patients interviewed by their own treating doctor and/or institution, and sometimes while still institutionalized, bias is toward underreporting of adverse effects

Ambiguous inquiries about “memory”, without distinguishing between memory, memory ability, and cognitive abilities

Survivor research:

Researchers unpaid; work done at researcher’s own personal financial expense

Self-designed instruments designed by and for survivors to be sensitive to the deficits we commonly experience

Large sample sizes (<50)

Heterogeneous samples more representative of the ECT population as a whole:

Memory, memory ability, and cognition are studied directly, not as a sidebar to research on optimizing technique

Emphasis on describing discrete cognitive deficits rather than lumping them together with amnesia as "memory"

Patients are their own controls

Mostly very long-term follow-ups: patients who had ECT more than one year---and sometimes ten years or more---previously, thus eliminating replacing speculation with evidence as to whether adverse effects ultimately resolve

Because responding ex-patients are self-selecting, those with more severe adverse affects may be overrepresented

Because researchers are strangers and non-professionals, no incentive to underrreport adverse effects

ECT in India

ECT (ELECTRO CONVULSIVE THERAPY): NEED FOR DEBATE
Center for Advocacy in Mental Health

A research center of Bapu Trust, Pune, India

INTRODUCTION

The World Health Report, 2001 of the WHO is the most recent among a line of reports and documents suggesting the tremendous increase in the burden of mental disorders in developing regions. Several researchers (for example Patel, 1999) have underscored the “social determinants model” of mental health, where poor social and economic development is linked with increased risk for mental ill health. The poor and vulnerable groups are seen as being at high risk for common mental disorders (CMD). The research of the last decade on gender and mental health has also shown the greater vulnerability of men and women to substance abuse and depression respectively (Davar, 1999; 2001).

Incommensurate with the emerging epidemiological and social science data bases in mental health today, and the increasing awareness in society about mental disorder, there is a large gap in service provision and quality of care research or advocacy. When it comes to service provision, “cost effectiveness”, “risk benefit analysis”, etc. has led to some questionable arguments and conclusions, because of the lack of public debate. Only partisan views prevail in this area and the debate is polarized between medical professionals and human rights groups in mental health.

Two significant arguments made on the basis of cost effectiveness are the following:

(1) That direct ECT (Electro Convulsive Therapy) is the cheapest and most effective form of treatment (Andrade, 2003a, b; Tharyan, et. al. 1993) and

(2) That anti-depressants are better (cheaper and more effective) than placebo or psychological counseling in the treatment of depression (Patel et al 2003).

Both these arguments boost the prominent bio-medical profile and future of mental health provision in India. With a view to starting a public debate on community alternatives and quality of care in mental health service provision, in this paper, we take a position regarding the recent advocacy promoting the use of direct ECT (i.e. shock treatment without anesthesia), as the cheapest, and most effective form of treatment for mental disorders (Andrade, 2003a, b; Tharyan, et. al. 1993).

We argue that direct ECT is a controversial, hazardous and traumatizing procedure. There is no contemporary evidence base for the use of the procedure. There is an uncommon degree of death, injury, terror and trauma caused by the procedure. And finally, there is a high potential for abusing it as a form of punishment. These factors, we conclude, makes direct ECT an instrument of torture, rather than of treatment. The use of the procedure must be brought within human rights jurisprudence and should be the subject of consumer action and litigation. Regulatory bodies such as the IECs, Medical Research Council and the Psychiatric Society should stop further research on direct ECT.

We do admit that families may have obtained beneficial results from use of the ECT when administered well. However, we agree with Pathare (2003) who writes that people friendly, psychotherapeutic and community-based options must be developed instead of routinely prescribing ECT on the basis of the “poor country” argument. The topic of ECT in general and its relevance in community mental health must be more widely debated.

1. ELECTRO-CONVULSIVE THERAPY (ECT): OUT OF THE CLOSET

Finally, the subject is out of the closet. Shock treatment has always been a taboo subject in India. It has been an esoteric topic discussed in medical forums, but never brought up before for public debate. Recently, in the wake of the Supreme Court approval of the procedure, a prominent psychiatrist has written making a case for direct ECT (Andrade, 2003a, b). This article follows in a line of other articles advocating direct ECT in recent times (Tharyan, et al 1993). This resurgence of direct ECT is risky in mental health service provision in India.

1.1 What is ECT?

In ECT, an electrical current of between 70 to 170 volts is passed for between 0.5 and 1.5 seconds. In direct ECT, the body is thrown into frank epilepsy like seizures. While the patient is conscious in the beginning, he or she is rendered unconscious when the grand mal seizure starts. He is held down physically by staff to prevent fractures and internal injuries. The risk of injury is high. As the procedure is usually given in series, this hazard is experienced again and again. In an ideal text book situation, the procedure is repeated between 6 to 10 times. But continuous dosing of up to 20 times or more is neither unknown nor uncommon in India.

In its “modern” or “modified” form (Modified ECT), text book practice suggests that the patient should not eat or drink for four hours or more before the procedure, to reduce the risk of vomiting and incontinence. Medication may be given to reduce the mouth secretions. Muscle relaxants and anesthesia are given to reduce the overt epileptic / muscular convulsions. The muscle relaxant paralyzes all the muscles of the body, including those of the respiratory system. Anxiety may be caused to the patient due to a sense of suffocation and anesthesia is given to prevent the anxiety. General anesthesia is given intravenously to make the patient unconscious. A “crash cart” is kept nearby, with a variety of life-saving devices and medications, including a defibrillator for kick starting the heart in case of a cardiac arrest. The brain is subjected to seizure activity induced by the electrical current, as it is believed that seizure is the essentially curative. The causal mechanism by which the treatment works is not known. Endocrinological, neurotransmitter and other changes have drawn a blank (Kiloh, et al 1988). It is believed that electricity itself and the seizure activity it produces is the curing element.

To get a picture of the procedure, read below, a full narrative of the experience of modified ECT, reported by doctors in 1988:

“In a generalized seizure (grand mal) the patient loses consciousness immediately and the whole musculature goes into a powerful tonic spasm. The upper limbs are held close to the body with flexion of the wrists and fingers, while the lower limbs extend with inversion of the feet and flexion of the toes. The trunk muscles contract and as the extensor muscles are the more powerful the spine tends to become hyperextended. The respiratory muscles are involved so that respiration ceases. The pupils dilate and become inactive and the eyes are insensitive to touch. There is an increase in heart rate and a rise in both systolic and diastolic blood pressure. If the bladder or bowel are distended at the time of the fit, either or both may be evacuated. The tonic phase usually lasts some 10-30 s followed by a partial, brief relaxation of muscles and a swift return of the spasm. Violent jerks then convulse the body in rapid succession and blood-stained froth may exude from the mouth. The clonic jerkings continue, the intervals between them lengthening, until with a final jerk the clonic stage terminates. At this point a degree of cyanosis is usual but after a brief period of flaccidity breathing is re-established. Often as consciousness begins to return, the patient passes into a deep sleep. If this does not occur the patient shows evidence of confusion with disorientation and may talk in a rambling and disjointed manner sometimes with paraphasias. The patient is likely to be restless and may show excited behaviour perhaps becoming irritable, angry and even violent” (Kiloh, et. al. 1988: p. 189).

1.2 Use of ECT in India

Only a few scattered articles exist in India, mostly published in the official journal of the Indian Psychiatric Society (Indian Journal of Psychiatry), on direct ECT practice. Vahia et al’s early study (1974) reported that in Bombay, 10580 patients out of 12,540 were given direct ECT, a large proportion of the help seeking population. Davar (1999) reviewing secondary literature wrote that, unlike the trend in the west, the use of ECT increased 20-fold in a hospital in Mumbai over a decade. Agarwal, Andrade and Reddy (1992) reported that direct ECT is widely practiced in India as a form of psychiatric treatment. Sharma and Chadda’s (1990) review of hospital facilities also showed that a majority of Indian mental hospitals used direct ECT.

Agarwal and Andrade (1997) studied the attitudes of psychiatrists towards ECT. Of 263 respondents 2.7% strongly objected to the procedure and another 9.5% generally opposed. Another 5.3% had no feelings one way or another. 64.3% were generally favourable, another 12.5% were decidedly favourable. 80% of doctors felt that ECT is the safest, cheapest and most effective form of treatment. A fair majority disagreed that ECT should be used when all else failed. The researchers are “reassured that most felt positive towards ECT”.

Professionals claim that patients are overwhelmingly happy about the effects of ECT (Andrade, 2003b). However, there is no experiential or quantified consumer satisfaction research to back this up. Not surprisingly, patient views on ECT are completely missing in the literature. Experiential accounts of staff or doctors, who have administered the procedure, are not available. There are problems, as we will see, about doing such studies. One study done during the direct ECT era (Verghese, Gupta & Prabhu, 1968) reported that not a single patient out of 36, voluntarily opted for ECT. 26 passively submitted, 8 had apprehensions and 2 strongly objected. This study reported memory loss and marked disorientation following the treatment. This is the only consent study we have found reported in literature.

1.3 SC interest in direct ECT

As readers of EPW may be aware, direct ECT has been placed as a controversial and contested issue before the Supreme Court recently. In the month of August, 2001, 28 people labeled with mental illness perished in a fire tragedy in Ramanathapuram district of Tamil Nadu. The manager of the private shelter in Erwadi had kept them tied to their cots, and so, escape was impossible. The SC took suo moto action and ordered all State Governments to file affidavits on a continuing basis, tabling information on the following topics: the availability of services within the state for mental disorders; whether the Mental Health Act has been implemented; the functioning of the State Mental Health Authority (SMHA); information on religious healing sites and whether mentally ill persons have been kept in chains in any part of the state. The SC appointed an amicus curiae to make recommendations, to field relevant information to the court and to process related petitions that may be filed by the public.

Direct ECT is considered a most contested and controversial procedure in the treatment of mental disorders. Saarthak, an NGO working for persons with mental illness in New Delhi, filed a petition before the SC appealing mainly the following: limitations on physical restraint, an unconditional ban on direct ECT and removal of Section (81.2) of the Mental Health Act, which allows proxy consent for research on persons with mental illness (Writ Petition No. 562/2001 in Saarthak vs. Union of India). While noting that ECT is not the top question for discussion in mental health today, Pathare (2003) has written responding to the Saarthak petition: “This debate [direct vs. modified] is a non-starter: it is accepted the world over that ECT must be administered in a modified form. It has been argued that there is a special case for permitting direct ECT in India because of the lack of facilities for anesthesia and to reduce the costs of treatment. Both these arguments are spurious. ECT is a major procedure and must be carried out under reasonably safe medical conditions” (p. 11). Not many professionals have written in response to the SC intervention.

The response of the state and the judiciary to use of direct ECT has however been ambivalent. In response to the SC orders, many states have reported that direct ECT is being phased out and that as per modern practice, only modified ECT is being used. Some states have given a justification for continuing the use of direct ECT, while also certifying that in their State this practice is not being followed.

In their final judgment, the apex court noted that “ECT remains effective in several major mental disorders”. It is “life saving” and reduces the “risk of suicide”. It further states, notoriously, that direct ECT is safer than modified ECT, as in the latter the risk of use of anesthesia and muscle relaxants is added. Dr. D. Mohan, Psychiatrist, AIIMS advised the apex court, in this instance. The doctor observes a mortality rate of “only 0.03%” in direct ECT, considered clinically insignificant, where as with modified ECT risks of use of anesthesia are to be added. Dr Gauri Devi, erstwhile director of NIMHANS, wrote observing mainly that modified ECT is a non-issue in the treatment of certain mental disorders. But she did not frontally address the issue of direct ECT, the central topic of the Saarthak litigation.

The Supreme Court judgment in this regard raises several questions about the interphase between law and science, the responsibility of medical professionals when giving testimony or scientific evidence, and the collective responsibility of the sciences and the judiciary, towards establishing certain standards of quality health care. The AIIMS professional did not give the background database about direct ECT, or explore the controversy surrounding it, even as a matter of informing the court. Instead of treating this as a quality of care issue and as an investigative matter, he “certified” the procedure as safe, raising the concern about questionable authorisation. The court, on its part, considered the certification given by a couple of psychiatrists as sufficient for making a decision. The Saarthak petition with respect to ECT was not treated with the respect that it deserved by the judiciary or by the professional community.

Around the world, in well-developed legal or policy formulations on involuntary commitments for mental illness, there are provisions and sanctions on the use of (modified) ECT. In India, legal or policy instruments in mental health do not address the procedure of ECT. The Mental Health Act, 1987, is about the institutionalization of persons with mental illness through commitment procedures. The Act was formulated in the context of involuntary commitment of persons labelled with mental illness – a reality in mental health care. Involuntary commitment ill automatically cancels the constitutional right of liberty (Dhanda, 2001) and a further law was required to allow this to happen within the law. However, the Act makes no mention at all of ECT, the top notch instrument of involuntary treatment in mental health care.

A few premier mental health institutions in the country have internal guidelines for the practice of ECT within their institution. At a National workshop on ECT in NIMHANS in 1990, members of the Indian Psychiatric Society recommended the use of modified ECT, in the presence of a qualified anesthetist as the norm for clinical practice. In a meeting of the State Health Secretaries in Bangalore in June, 1999, organized by NIMHANS, modified ECT has been recommended. Regulation of direct ECT has happened in some states of India mainly by High Court interventions. The Bombay High Court recommended against the use of direct ECT way back in 1989, following the Mahajan Committee Recommendations. In Goa too, due to legal advocacy and the proactive role of psychiatrists there, direct ECT has been banned (WP (Civil) No. 257, 1998, Collossa vs. State of Goa in the High Court of Mumbai). In Japan, ECT is used, just as in India, without anesthesia (Minkowitz, 2002), often as a type of punishment for political prisoners. Some countries in the Central and South of America continue to use direct ECT, and international human rights organizations are involved in challenging and reforming the practice.

1.4 Status of Direct ECT in the developed world

If we were to ask, “what is the evidence base which will validate the use of direct ECT” it is difficult to find the answer. It is difficult to find materials on direct ECT in world academic journals of the last 30 years. The only “evidence base” cited is the one or two studies done in India itself, Tharyan, et. al.’s eleven year study (1993) being a very significant one. Indian professionals advocating direct ECT will not find international academic journals, which will publish their articles, and so such articles are published in the obscure Indian Journal of Psychiatry. The world professional community considers the procedure of shock treatment without anesthesia, as barbaric and obsolete.

Many European countries including Holland have phased out even modified ECT, with other countries drastically reducing usage. In the US, use of ECT came down by 46% following consumer action between 1975 and 1980. As awareness about quality care and patient self-determination grows in mental health, every “forced ECT” (i.e. modified ECT where patient has not consented) in any part of the US elicits immediate activism, direct consumer action and patient litigation. In the words of LR Frank, who is called the “Gandhi” of mental health activism in the US, “ECT is a brutal, dehumanizing, memory-destroying, intelligence-lowering, brain-damaging, brain-washing, life threatening technique. ECT robs people of their memories, their personality and their humanity. It is a method for gutting the brain in order to control and punish people who fall or step out of line, and intimate others who are on the verge of doing so” (Frank, 2003: p. 17). Several efforts are on to ban the use of even modified ECT, some of them with partial success. The American Psychiatric Association survey of 1978 showed that only 16% of psychiatrists in the US gave ECT. Consumer groups in mental health maintain “Shock Doctor Rosters”, registering and shaming in public all doctors who indiscriminately prescribe shock treatments, and who do not offer a whole range of other psychotherapeutic opportunities.

This is why Dr Andrade’s recent article (2203a), which has set off a recent controversy in Issues in Medical Ethics, is incredibly astonishing and terribly disappointing. The paper does not even place an exclamation mark in making a case for direct ECT. To make a case for direct ECT in today’s context establishes a fresh, new low for psychiatric ethics in India. So, instead of debating the issue of ‘whether or not ECT at all’, and what other people and user-friendly alternatives we can create in mental health, we are placed in this ridiculous situation of debating direct ECT.

2. IMPACT OF DIRECT ECT

Any discussion on direct ECT, as mentioned above, has to draw from literature that is dated by atleast three decades. It is important to ask, why did the developed world ban the practice? Two major effects of direct ECT led to the phasing out of this procedure in the west– One, relating to the death and injury, and second, relating to the terror and the trauma, caused by the procedure on patients. We discuss these two aspects in this section and the next.

2.1 Injury caused by direct ECT

Direct ECT was invented in curious circumstances. The Italian, Ugo Cerletti, was inspired by the fact that electricity was used in preparing pigs for slaughter in an abattoir. They were rendered unconscious by bilateral placement of electrodes and passing current. Convulsions preceded the loss of consciousness. Following much experimentation on the pigs, he and his colleague, Lucio Bini invented the ECT procedure in 1938 when they first induced an artificial convulsion in a man (Kiloh, et. al., 1988). The man in question was a wandering mentally ill person. In 1940s and 1950s ECT use greatly increased, with experimental research on direct ECT holding sway.

Soon the data on death and injury, which started emerging on direct ECT, was alarming enough to lead to a ban on the procedure. 0.5% to 20% reportedly experienced vertebral fractures in use of direct ECT (Wiseman, pp. 118-119). In the UK, what stopped direct ECT was a well-known case, Bolam v. Friern Barnet Hospital Management Committee, when the patient sustained pelvic fracture. The US army forbade use of ECT during World War II in the early days, but with the increasing role of psychiatrists in the military during this time, it was reintroduced in 1943. The “Young Turks” of the nascent American Psychiatric Society railed against the “promiscuous and indiscriminate use of ECT” in 1947.

Professionals claim (Andrade 2000; 2003a; Tharyan et al 1993) that direct ECT is risk free. Infact, the world experience shows that direct ECT is not safe. As Andrade (2003a) himself mentions, reviewing previous research done in the 40s and 50s, direct ECT is associated with risk of vertebral / thoracic fractures, dislocation of various joints, muscle or ligament tears, cardiac arrhythmias, fluid secretion into the respiratory tract, internal tears, haemorrhages and blood letting, other than fear and anxiety. Risks are greater in males, older subjects, pregnant women and those with osteoporosis. Their own study (Andrade et al 2000) had found that “only 2%” of patients (i.e. 1 out of every 50 patients) experienced “an adverse musculoskeletal event with unmodified ECT”. Tharyan, et al (1993) enlist the risks involved in direct ECT: fractures of the spine, femur, humerus, acetabulum, scapula; dislocations of the arm, jaw and hip; rupture of abdominal muscles; fat embolism; rupture or bleeding of internal organs or viscera and increased apprehension. They do not mention cardiac complications and death, both of which their own study reported.

For “evidence base”, Andrade (2003a) cites the earlier study by Tharyan, et al. (1993), advocating direct ECT. First, a single study is not “an evidence base”. Secondly, this study itself needs careful examination. Andrade writes that in this study, only 12 patients experienced fractures out of a total of 1835 patients receiving 13,597 treatments. In the way the data from this study has been re-presented, it sounds as if a few of the patients walked out of the ECT table with a slight twisting of the middle finger. Andrade fails to mention all the relevant data from this study. The fractures that patients had during this study were thoracic / vertebral fractures involving almost a third of the body vertebrae. The sudden onset of convulsions has a crushing impact on the bones. The neurological disabilities and other orthopaedic consequences of these spinal injuries are unknown. Andrade also fails to mention that in this study, there was one reported death due to cardiac arrest (i.e. one patient out of 1835 died), a good percentage experienced body aches, both local and generalised, and another one percent of the patients had cardiac complications. These data, especially the high rate of spinal injury and mortality rate, which from the patient point of view seem horrific, are not considered “clinically significant” by the authors of this study. Absent, the professional standards for refusing any practice in psychiatry, there does not seem any other way of contesting this data except by throwing up your hands in horror.

Table 1: Complications. Click for larger view.

table.jpg

Source: Kiloh, et. al. (1988: pp.254-266) “True side effects” refers to inevitable events that always accompany ECT; “Complications” refers to infrequent but not rare events accompanying ECT; “risks” refers to unlikely events accompanying ECT; and “complaints” refers to the physical or somatic complaints associated with ECT. It must be highlighted that with modified ECT, such events are “less likely” but not completely ruled out.

2.2 Death due to ECT
The recent APA Task Force on ECT (2001) notes that contrary to earlier evidence, they have to now acknowledge that mortality rates with ECT (modified) may be as high as 1 in 10,000 patients. Consumers (Frank, 2002) say that mortality rates may be as high as 1% with modified ECT. The mortality rates are probably higher among the elderly. The Task Force report also notes that 1 in 200 will experience irretrievable memory loss, a fact hitherto dismissed as irrelevant by the medical fraternity.

Death in the case of ECT is usually due to cardio-vascular or cerebral-vascular complications, followed by respiratory failure. Shukla (1985), in discussing a case report of death following modified ECT, reviews the mortality data associated with the procedure. Rates between 0.8% and 0.003% have been reported in the western literature. Shukla, finding it a curious fact that deaths have not been reported at all in the Indian professional literature, observes that fatalities are not always publicly reported, particularly in India, but every psychiatrist would have experienced such cases in his practice.

3. DIRECT ECT AS TRAUMA
Leo Frank, an ex-patient subjected to many years of insulin treatment and direct ECT, says, “Why is it that 10v of electricity applied to a political prisoner’s private parts is seen as torture, while 10 or 15 times that amount applied to the brain is called “treatment”?” (2002, p. 19). Many human rights instruments around the world cover the area of the psychiatric system also, as medical coercion and violence, the loss of liberty, political abuse and being incarcerated through misuse of the criminal justice system is high in this health care sector. Involuntary commitment, patient consent, restraint and limits to coercive treatment are covered in human rights jurisprudence because of the fact that this constituency is particularly at risk for loss of constitutional rights. The UN Principles of 1991 also enlists fundamental rights and freedoms of psychiatric patients, and right to quality health care, as such explicit protection is seen as necessary for this vulnerable population. The Council of Europe came out with a White Paper (2000) on “protection of rights” of mentally ill patients and the Convention for Prevention of Torture (2002) also covers involuntary commitment. The ICCPR also covers the rights of institutionalized patients. As the label of mental disorder literally deletes personhood, such human rights safe guards are seen as necessary.

In India, we do not have human rights instruments covering the fundamental rights and freedoms of psychiatric patients. (The Mental Health Act, even though it has a human rights chapter, makes some general statements on such rights such as “no cruelty”). Such instruments are necessary because such patients are the most vulnerable within the community and risk abuse and civil rights violation on a daily basis (Dhanda, 2001).

In developing this instrument, use of direct ECT must be enlisted as a type of torture and as a human rights violation, as found in other world conventions. The European CPT (Convention for the Prevention of Torture) 2002 prohibits the use of direct ECT as a form of torture. The Convention says: “The CPT is particularly concerned when it encounters the administration of ECT in its unmodified form; this method can no longer be considered as acceptable in modern psychiatric practice. ECT should always be administered in a modified form” (Chapter VI, Section 39). One of the reasons cited by the CPT for prohibition on direct ECT is the terror experienced by patients during and after the procedure. The White paper (2000) on the “Protection of the human rights and dignity of people suffering from mental disorder, especially those placed in a psychiatric establishment” drafted by the Working Party of the Steering Committee on Bio Ethics (CDBI), Council of Europe, also prohibits the use of direct ECT.

3.1 Mental effects of direct ECT
Nearly all patients suffer amnesia about the period around which they were given ECT. People given ECT do not remember the experience itself and are not able to report on what it felt like to be given an ECT. In fact, this is a good reason why getting patient experiences of ECT is near impossible: As in trauma, the memories about the experience itself are not available to the conscious mind. Why does memory get wiped out, is a question that all concerned people have been grappling with for a long time. Earlier, professionals used to actually believe that brain damage is curative. We have also heard the clich? that “why would patients want to remember painful memories about mental disorder”, mistakenly suggesting that such memories were wiped out selectively. Advocates against the procedure argue that since it traumatizes the brain, memories are wiped out.

Direct ECT, as a treatment procedure, causes several disruptive psychological effects (Wiseman, 1995). Patient stories show that loss of memory and concentration are common. This affects personal lives (loss of cherished memories), and job performance (technical or mathematical memory, which can be the basic skill for engineers, lawyers or accountants can be lost). Artistic abilities can be lost. Because of this, there is the risk of having to do mechanical unskilled jobs, be unemployed, lose relationships, etc. Confusion, self-doubt due to the loss of memory, uncertainty, increased helplessness, loss of ability to learn and unlearn, lethargy, loss of ability in cognitive subjects will be experienced by many. Suicide and increased violence has also been associated following the use of ECT.

It is common experience in India, too, that patients are terrified of ECT. Within institutional settings, taking someone for ECT is experienced as a punishment by the patients. There is an undercurrent of humilation, shaming and punitive action in the use of the procedure within institutional contexts. Few patients, even those who actually find it beneficial, escape the sense of rage and humiliation that the procedure evokes. As direct ECT is very much like what is crudely shown on bollywood films, the fear and apprehension is quite understandable.

Direct ECT, in the medical narratives, comes across as any other stimulus, which freezes a person in terror, fear and pain. The terror associated with the procedure is a sign of trauma, and not a sign of insanity. As Breggin writes, ECT evokes raw survival fears to the fore. Even the highest experts on ECT (Abrams, et al pp. 130-131) have written that organic brain syndrome to varying degrees is common following all ECTs. ECT may affect all aspects of the brain system including thoughts, feelings and behaviours. EEG abnormalities may not go away for several months or years following ECT, indicating continuing brain seizure activities and possible brain damage. Other psychiatric experts write: “What cannot be denied is that transient forms of brain dysfunction, sometimes of considerable severity, occur with the Cerletti-Bini technique [direct ECT] particularly in elderly patients” (Kiloh, et. al., 1988: p. 190). The most evident effect of ECT on the brain was the vegetativeness of the patient, and reduction in his motor abilities. In fact, psychiatrists of yore believed that temporary brain damage effects the “cure” of mental illness (p. 213).

Direct ECT was described even in doctor’s narratives as somewhat close to lobotomy, the surgical removal of a portion of the frontal brain. Early doctors who gave direct ECT expected “regression”, a state when the patient was meek and submissive, wetting or soiling themselves, whimpering and crying easily, like a child. A writer in the Diseases of the Nervous System wrote, in 1951: “By the end of this intensive course of treatment practically all 52 patients showed profound disturbances. All showed incontinence of urine, and incontinence of feces was not uncommon. Most of them were underactive and did not talk spontaneously. Many failed to respond to questions but a few patients would obey simple requests. They appeared prostrated and apathetic. At the same time, most of them whined, whimpered and cried readily, and some were resistant and petulant in a child like way” (Wiseman, pp.118-119). The suggestion in literature is that ECT affects the limbic system of the brain, the same system that is affected by deep trauma.

In the UK, following the famous case against direct ECT, there was also a general consensus among professionals and policy makers that its unpleasant effects gave more scope for it to be used as a punishing tool, and several such stories did emerge until the 1980s. Case after case indicates that ECT is made as a choice of treatment in the case of “unmanageable” patients. ECT quiets the patients and remits agitation immediately, for unknown reasons. Within institutional contexts, therefore, the risk of abuse of the procedure is high. In India, although there is negligible documentation, direct ECT has been used as a punishment by families in collusion with psychiatrists against errant daughters and given to cure “naxalism” (Ramaswamy, 1999). For many years, the writer has suffered irretrievable memory loss. ECT has been given in India for all and sundry problems, including “curing” homosexuality. The use of direct ECT for dealing with political prisoners in Japan is also known (Minkowitz, 2002).

3.2 Use of sedation to allay fear
The fear associated with direct ECT is equal to the fear caused by any instrument of punishment and torture, and it is not a sign of insanity. It is the prejudicial attitude of professionals towards persons with mental illness, which allows them to interpret every response to their treatment as a symptom warranting further abusive treatment. With this logic, it will never be possible for a patient diagnosed with mental illness, to ever raise a question about the treatment they receive, for all such questions will risk being interpreted as a “psychiatric symptom”. Infact, Peter Breggin (1993), an erstwhile psychiatrist who gave up the profession in disgust over its abusive practices, and joined the mental health consumer movement as a researcher and a social scientist, wrote that the most dangerous impact of ECT was that the patient is no longer in a position to protest the damage done to him (p. 240). This strategy of seeing patient refusal of a particular treatment, as symptomatic behaviour, is evident in Tharyan et al’s study as well, which we discuss below. Such attitudes diminish the self determination of the patient in his or her own care.

In Tharyan et al’s opinion fuelling study, too, a high percentage of patients (7.5%) reported fear and apprehension of the procedure, and 50 patients actually refused the treatment. On ordinary ethical conditions of doing human behavioural research, we assume that such subjects would have been allowed to drop out of the study. How did the researchers proceed with this frightened sample of 150 patients?

Well, they did so, by actually sedating them and getting them to comply. Quoting them in full: “A fifty of them [patients] refused further ECT due to this fear while in the remainder (100 patients) the fear was reduced by sedative premeditation enabling them to complete the course of ECT. In the earlier half of the decade under review, barbiturates, oral diazepam, parenteral haloperidol and even thiopentone were used to allay anxiety; in recent years, this has been effectively managed by pretreatment with 1 to 4 mg of lorazepam given orally”. Further, it was interesting for these authors to observe that those who refused ECT were not among those who were sedated, that is, most of those sedated complied.

Such is the prejudicial approach to mentally ill patients, that refusal of a hazardous and life-threatening procedure is considered as a mere symptom, and further treated with sedatives to obtain patient compliance. We are of course aware of other power situations, such as rape or wife battery, when refusal is treated as consent. Tharyan et al’s study also suggests that it is common practice to sedate patients who refuse ECT. Amazingly, in their list of recommendations, they recommend the use of sedatives to minimize the fear of ECT among the patients. Their political message seems to be that, if people refuse a hazardous treatment, or if they will not participate in research that involves study of such a treatment, then it is okay sedate them. Patient ethics fundamentally rests on the principle of autonomy, which is seriously violated with this approach.

The world data of three decades already exists to rule out the procedure as barbaric. No further research is necessary on direct ECT. And if over six decades of ECT research has come up with little hard data on the causal effects of its beneficence, except the vague claim that electricity itself causes the cure, then perhaps it is time to question the assumption of its value in mental health service provision. Andrade recommends systematic sampling and interviewing of patients who have received ECT, as “dissatisfied patients can be found for all treatments?” (pp. 44-45). This call for quantified survey data on patient experience of direct ECT is against the very basis of human rights jurisprudence, where a single case of violation is indeed representative.

Because of the physical and mental trauma caused by the procedure, patients given direct ECT must be considered as victims of torture and the perpetrators of this form of torture must be brought within human rights jurisprudence. Direct ECT research should not be allowed to happen in future, as this would be a clear human rights violation. Statutory authorities, institutional ethics committees and consumer bodies must ask explanations regarding the recent highly objectionable research done on direct ECT.
4. WHY DIRECT ECT
The main argument used by Tharyan, et al (1993), Andrade (2003) and others is that direct ECT is “cost-effective”. The dogma among professionals is that direct ECT is the cheapest and safest form of treatment for mental disorder, as it does not require medical facilities and an anesthetist. It is argued that in a resource poor setting, we have to compare “existing alternatives”, use the cheapest means available for cure, and not go for the most ideal (modified ECT). If the choice were between no ECT and direct ECT, then direct ECT is considered to be the more “ethical” alternative in the treatment of mental disorders. We question these arguments in this last section.

4.1 ECT is not a cure

Andrade (2003b) argues that:

“From an emotional perspective, a seizure-inducing treatment could certainly seem barbaric. However, if ECT is barbaric or unattractive, so too are cardioversions, abortions, Caesarean sections, radical mastectomies, open heart surgeries, orthopaedic and neurosurgical interventions, and so where does one draw the line?” (p. 44)

It is misleading to compare ECT with major surgery in justifying usage. Surgery intends to cure. But ECT is palliative, not curative. This means that in practice, professionals use it repeatedly as and when they like as, palliative care being an ongoing need, unlike curative care. Infact, relapse rate has been reportedly high in the use of ECT for schizophrenia and patients have to go for ECT “like an addiction”, in the words of someone who has experienced the treatment. Within the span of a week or two, mastectomies or open heart surgeries are not prescribed in series. It would incredibly impoverish families and patients, if this were so. The text book prescribes 6 to 10 sessions of ECT, unlike the case of surgery. If we wish to adopt the surgery metaphor, then, ideally, the procedure would be used as a last resort. However, ECT is used often as the first line of treatment for dealing with mental disorders in India. Over-prescription is the rule rather than the exception. In the cost-effectiveness argument, are such realities of practice taken into account?

Finally, the stout evidence base underlying surgery is simply not comparable to the very weak epistemological foundations of ECT. Mental sciences in general suffer from weak epistemologies (Davar and Bhat, 1995) when compared to the natural sciences. Professionals cannot say how ECT works. Neurotransmitter and endocrinological studies have drawn a blank (Kiloh, et al 1988), and all that can be said is that electricity itself cures.

4.2 Training for direct ECT
Tharyan, et al’s study (1993) reassures the reader that in giving direct ECT, “trained” professionals were used to give direct ECT. What does “training” mean in the context of giving direct ECT? You just need some physically very strong people to tie down the patient in strategic points and to keep the jaw and joint areas from major injury. [If we were to include direct ECT in our community mental health, NGO training or volunteer training programs, what kind of programs will we have to run? Training Programs on "Accident management during ECT", "Bone setting and suturing course for ECT managers", "Martial arts and body techniques for CHWs giving direct ECTs", etc. seem appropriate titles.]

However that may be, in Tharyan et al’s study (1993), the composition of the full “trained team” used to prevent injury were the following: four orderlies, three nurses, two postgraduate trainees and a consultant psychiatrist, that is, a total of 10 “trained” people! If cost-effectiveness is our preferred parameter for “ethically” choosing a particular option, wouldn’t it be just cheaper to hire an anesthetist? It is unrealistic that in the actual settings where direct ECTs are going to be used, for example, the district hospital or the private clinic, there would be so many “trained” people to audit the ECT procedure. The research situation was an ideal situation, unlike the practice situation. Even here, with a full load of 10 people tying down a patient from the convulsions, the reported injury rate was not insignificant.

Another aspect of cost is highlighted by Kiloh, et. al. (1988) (who in general approve of ECT as a sound treatment in some cases). They cite studies of patients wherein, following ECT, the depressive symptoms remitted immediately, but they had to stay in the hospital for a week to clear their “confusion, memory loss, euphoria, lability of mood and affect, and impaired judgement” (p. 251). In the case of direct ECT, we can expect that the costs of injury, illhealth and disability are higher. We wonder if these costs have been factored into the dogma about the cost-effectiveness of direct ECT.
4.3 ECT is lucrative
While we question the faith that direct ECT is cost effective for the patient, we suspect that it is lucrative for the doctor. In the US (Wiseman, 1995; Kiloh et al 1988), ECT research is conducted by very few organizations. Large research, medical foundations and psychiatric learned societies do not fund ECT research. The medical fraternity looks down upon the procedure. The government does not fund ECT research, and it is not often used in the federal, and state hospitals. However, this trend may be changing with the recent American Psychiatric Association’s approval of the procedure.

In India, ECT is lucrative business. It falls within specialist practice. In nearly every city in India, a majority of psychiatrists practice privately and give ECT in their private clinics. In Pune city for example, nearly 90% of psychiatrists are in private practice, with the public mental health system having become literally dysfunctional. They cater mainly to the middle class with fees ranging between 100 rupees to 500 rupees per consultation. A recent survey in western India showed that nearly 80% of private psychiatrists give ECT, costing anywhere between 500 to 1000 rupees per dosage. If we set the dosage at textbook level (i.e. 6 to 10 ECTs), the total cost would be anywhere between 3,000/= to 10,000/= rupees per series. Direct ECT is a money-spinner for many psychiatrists in the business. There are unscrupulous psychiatrists who ask the patient to first take an ECT before even consultation (Bapu workshop, 2002)!

4.4 Policy regulation absent
In India, ECT is given without restriction for anything and everything, often as first line of treatment, for even “curing” homosexuality. Andrade (2003a) writes that ECT is given to catatonic, suicidal, or otherwise “highly disturbed” patients. To say that “highly disturbed” patients can be given ECT allows too much ambiguity and scope for abuse of the procedure. In the direct ECT era, Shukla (1974) recommended use of direct ECT as a solution for passing a nasal tube to catatonic patients who refuse food: “At times it is very difficult to pass a tube even under sedation. I have tried the following in such patients with a 100% success: I give the patient direct ECT. (There are no problems as these patients are usually fasting and their stomach, bowel and bladder are empty). As soon as the convulsions stop and the patient is in a flaccid state, I pass the tube and it goes in very easily” (p. 95).

Policy guidelines and evidence base repeatedly comes up with only one diagnosis where ECT may be tried if other treatments fail- that is in the case of endogenous depression. Some documents do say that in this case, modified ECT can also be tried as first line of treatment, but enlist further conditions, including patient consent, an active audit program in each ECT department. The CPT 2002 also talks about patient consent and ECT audit, including a registry of ECT.

Reviews of research on the use of ECT in the case of schizophrenia upto the mid ’80s, when ECT research was at its peak, shows that
1. It is not possible to be emphatic about the value of ECT in patients diagnosed with schizophrenia
2. ECT and neuroleptic drugs have the same outcomes statistically
3. The relapse rate is high in use of ECT, showing that it probably has short term benefits

On the basis of the review, Kiloh et al (1988) observe that “the question whether the long-term effects of neuroleptic drugs, notably tardive dyskinesia, are more or less disabling than the possible ill effects of long term ECT cannot be answered” (p. 244).

ECT guidelines do not exist in India, making it a huge ethical issue among patients and consumers. Indian psychiatrists recognize the cavalier use of ECT. Agarwal (1990) in his editorial notes remarkable deficiencies in the administration of ECT even in the West, writing, “the situation in India is bound to be more disappointing”. ECT in India is often prescribed in series, without any review, the conditions for safe use and correct use are not specified, the staff giving ECT are often untrained, and physical pre-exam is often not done, as it is felt that ECT is safe for anyone and everyone (“virtually no contradictions”, according to the psychiatric dogma).

Patient consent:
The community mental health program in India (NMHP, 1982) promises to take mental health services to the community. Unfortunately, in most parts of India, it has remained a drug and ECT dispensing service, with minimal understanding or engagement with the community. The advocacy for direct ECT is likely to increase misuse of ECT in private practice and in the community mental health programs. Lack of awareness among communities about this procedure is likely to be harvested by unscrupulous professionals. As people with mental illness are not considered fit to give consent, patient consent is rarely addressed. In many hospitals, patients and their families are only told that they are receiving an “injection”, as it is argued that patients will not understand the procedure. Consent letters, if used at all, are signed on that basis. See, for example, the narrative below.

“In the beginning my husband did not benefit from the medicine, so he had to be given shots. And while giving shots also they take [the patient] with great love and affection, not that they tied and took him. They will lure you and take you. There are two or three employees. Those who try to run, they have to be stern with them. Even for shots? because there is a danger that perhaps they may die? attention has to be paid even to their teeth that they should not dislocate or fall. When shots are administered the teeth is clenched and it clatters? the entire jaw may even come out, so they put a big bandage inside. If it moves, the entire set both can come out in that bandage. They would tell you before hand that you keep either milk or tea ready.”

Quality of care
The research cited in this paper advocating direct ECT was done under ideal treatment conditions. The institutions where the research was conducted (NIMHANS, CMC) were well funded public health institutions, with a promise of high quality care. Adequate staff were allocated for the research. Under ideal conditions, the injury rate is not insignificant, as we have argued above. What can we expect from less than ideal conditions? We give a case study below:

“Meena” was imprisoned in a Maharashtra jail for killing her sister. She suffered from “voices in the head” for several years. After the accident, she was arrested and then taken for treatment. Here we present a portion of her experiences with shock treatment without anesthesia:

“I was totally maddened by this time. The police arrested me and kept me in the lock-up. I felt very remorseful after that. They later took me to a nearby famous hospital. There they gave me shock treatments. 4 shocks they gave me with anaesthesia and three shocks they gave me without anaesthesia. I remember feeling those three shocks while I was awake. I had not fainted, and could feel the shocks. It was extremely painful. They used not to give me any tea in the morning either. I would not allow them to put the cloth in my mouth. It was extremely painful. I suffered an enormous amount. It was the most horrible pain in my head. I don’t remember anything else about the time. I was also very rude with the doctors. The voices in my head stopped after that. I kept feeling remorseful about how I had killed my auntie’s only child. My aunty came to visit me in hospital also. I asked her whether she had told the doctors to give me shocks. She didn’t know anything about it. I was unconscious for 3 days after the shocks. It was very traumatic.”
We have all experienced the mundane pain of needles poking at our elbow because the poorly trained staffer “could not find a vein”. What are the effects of poorly administered direct ECT? The patient is rendered unconscious only when the grand mal seizure starts at a particular electrical threshold. Meena was probably given ECT without anesthesia at infra-threshold, so she did not become unconscious.

4.5 Other guidelines
Recently, in Utah, an ECT Bill passed by the House is being considered by the Senate in which consumer groups have had a large role to play. The proposed bill (www.le.state.ut.us/-2003/htmdoc/hbillhtm/HBO109S1.htm) does the following: It prohibits shock for children under the age of 14. It prohibits shock for individuals who are committed against their will. It prohibits a legal guardian to consent to shock for someone else. It requires a second medical opinion to shock someone over the age of 65. It requires that informed consent mentions that possible side effects of shock may include permanent memory loss, cardiac arrest and death. It requires a reporting system to show how many are shocked every year and if they suffer from any side effects within a certain amount of time. It requires that an autopsy be done if someone dies after shock, and that the autopsy look for brain damage by searching for destroyed small blood vessels. It allows free individuals over the age of 18 to receive shock after they get full informed consent.

The Royal College of Psychiatrists Commission Guidelines give conditions for anesthetic equipment, the ECT machine, staff requirements and treatment protocols. As direct ECT machines are obsolete, such machines would be ruled out by international standards. The FDA considers ECT machines as “Class III” devices, that is “hazardous”.

There is a need to investigate the condition and commerce of existing ECT machines in India, who makes these machines, who approves them, what are the standards for the machines. In UK, an internationally recognized advocate of ECT, Dr Abrams, who wrote the very popular reference book, Electroconvulsive Therapy, was found to be one of the two member Board of Directors of Somatics, a commercial venture involving ECT machine manufacture and sale. Half his yearly income was drawn from Somatics. While not making allusions to possibility or ethics of the commercial interests of any professional in the practice, we are indeed suggesting that the commerce of ECT needs to be more thoroughly investigated.

The National Mental Health Association, the largest non-profit mental health organization in the US, issued a public statement on the 11th of June, 2000. The statement says that the NMHA recognizes that ECT is a controversial procedure and that although it may have beneficial results, it also involves serious risks. It has urged the increased, rigorous and objective research, as well as dissemination of such research, on ECT especially from the safety point of view. The organization also supported the position that ECT recipients must be informed of all the pros and cons and have access to all kinds of information to be able to make fully informed decisions. NMHA further recommends that “ECT be presented as an alternative with extreme caution, only after all other treatment approaches have either failed or have been seriously and thoroughly evaluated and rejected” (www.nmha.org/position/ps31.crm).

CONCLUSION: THE NEED FOR PUBLIC DEBATE
There must be a public debate on the issue of the use of ECT in India. Most world data bases of the last decade, culminating in WHO’s World Health Report, 2001, have highlighted the phenomenal “increase” in the “burden” of mental disorders in developing countries. The spin-offs of globalisation and economic reform, (including debts, ethnic violence, poverty, homelessness, displacement and cultural loss) have resulted in the greater mental ill health of vulnerable groups. Poverty and mental disorder are being linked in a significant way in the literature. Meanwhile, there has been little challenge to the privatization of mental health and little is known about the influence of drug companies on the development of research, technology and service within the sector.

Advocating direct ECT against the background of the Indian reality of a questionable mental health care quality can be risky. Andrade writes that “if the risk-benefit ratio favours the treatment, and if the treatment is better than existing alternatives, in the interest of the patient the treatment must survive” and that “unmodified ECT may be preferable to no ECT” (2000b:p.44). The fact of not having created interesting and humane alternatives in mental health has been the pathos of the Indian mental health service system. It is disappointing that this fact should lead to advocacy of direct ECT, instead of fuelling the creation of imaginative psycho-therapeutic and community models. On the basis of the argument that India is a “poor” country and the poor need quick alternatives, justifications have also existed for various invasive and undignified “treatments”, such as mass sterilization, and hysterectomies, in the case of the mentally challenged girls.

Background to the paper
The ideas presented here are the result of several discussions in our Center by Aparna Waikar, Bhargavi Davar, Chandra Karhadkar, Darshana Bansode, Deepra Dandekar, Seema Kakade, Sonali Wayal, and Yogita Kulkarni. Bhargavi Davar did the research for this paper. Deepra Dandekar and Darshana Bansode submitted a case study from the “Archives” team of our Center, from their documentation of the plight of mentally ill women prisoners in Maharashtra. The community narrative on ECT as “injections” came from our “Needs Assessment Study of NGOs in mental health”. Fieldwork was done by Lalita Joshi and Seema Kakade for this study. Our activities are funded by Sir Dorabji Trust and Action Aid India.

References:
.Ramaswamy, G. (2001) “Remembered Rage” in Speaking our Minds. Aaina, A mental health advocacy newsletter, Vol. 1(1), March, p. 17.
.Minkowitz, T. (2002) “Psychiatric Disability in the UN Disability Convention”, Special Report-I, Aaina, Vol. 2 No. 3, November, p. 10
.Abrams, R., Essman WB (Eds) (1982) Electroconvulsive therapy: Biological Foundations and Clinical Applications. Lancaster: MTP Press Ltd.
.Agarwal, A.K. (1990) “ECT: A need for re-appraisal”. Editorial. Indian Journal of Psychiatry, 32(4) pp.295-296.
.Agarwal, A.K. and Andrade, C. (1997) “Indian psychiatrists’ attitudes towards electroconvulsive therapy”. Indian Journal of Psychiatry, 39(1), pp. 54-60.
.Agarwal, A.K., Andrade, C. and Reddy, M.V. (1992) “The practice of ECT in India. Issues relating to the administration of ECT”. Indian Journal of Psychiatry, 34(4), pp. 285-297.
.Andrade, C. (2003a) “Unmodified ECT: Ethical Issues”, Issues in Medical Ethics, Vol. 11 Issue 1, pp. 9-10.
.Andrade, C. (2003b) “ECT: A measured defence”, Issues in Medical Ethics, Vol. 11 Issue 2.
Andrade, C., Rele, K., Sutharshan, R., Shah, N. (2000) “Musculoskeletal morbidity with unmodified ECT may be less than earlier believed”, Indian Journal of Psychiatry, 42, pp. 156-162.
.APA Task Force on ECT (2001)
.Breggin, P. (1993) Toxic Psychiatry: Drugs and ECT, The Truth and the Better Alternatives. Harper Collins.
.Clinical Resource and Audit Group (CRAG) Working Group on Mental Illness (1997) Electroconvulsive Therapy (ECT): A Good Practice Statement. Edinburgh: CRAG.
.CPT, (2002) European Committee for the Prevention of Torture and Inhuman or degrading treatment or punishment, CPT – 2002, Chapter VI- Involuntary Commitment, Section 39 – ECT. Council of Europe.
.Davar, BV (1999) Mental health of Indian women. A feminist agenda. Sage Publications, New Delhi.
.Davar, B.V. (2001) Mental health from a gender perspective. Sage: New Delhi.
.Davar, B.V. & Bhat, P.R. (1995) Psychoanalysis as a human science: Beyond foundationalism. Sage: New Delhi.
.Dhanda, A. (2001) Legal order, mental disorder. Sage Publications, New Delhi.
Frank, LR 2003, “Electroshock: A crime against the spirit”, In a Nutshell, Fall/Winter 2002-2003, pp. 16-22.
.Kiloh, L.G., Smith, J.S., Johnson, G.F. (1988) Physical treatments in Psychiatry. Foreword by Sir Martin Roth. Blackwell.
.NIMHANS (1999) “Recommendations of national workshop for State Health Secretaries”, June 7th, 8th, Bangalore.
.Patel, V. (1998) Culture and Common Mental Disorders in Sub-Saharan Africa. UK: Psychology Press.
.Patel, V., Chisholm, D., Rabe-Hesketh, S., Dias-Saxena, F., Andrew, G. and Mann, A. (2003) “Efficacy and cost-effectiveness of drug and psychological treatments for CMD in GHC in Goa, India: A randomized, controlled trial”. Lancet, Vol. 361, pp.33-39.
.Pathare, S. (2003) “Beyond ECT”. Issues in Medical Ethics, XI(1) Jan-Mar, pp. 11-12
Royal College of Psychiatrists (1995) The ECT Handbook (Second Report of the Royal College of Psychiatrists’ Special Committee on ECT). Council Report CR39. London: Royal College of Psychiatrists.
.Shukla, G.D. (1985) “Death following ECT- A case report”, Indian Journal of Psychiatry, Vol. 27, Issue 01, pp. 95-97.
.Task Force Reports (1978, 1990, 2001) on ECT. American Psychiatric Association, USA.
.Tharyan, P., Saju, P.J., Datta, S., John, J.K., Kuruvilla, K. (1993) “Physical morbidity with unmodified ECT: a decade of experience”, Indian Journal of Psychiatry, 35, Issue 4, pp. 211-214.
.UN General Assembly Resolution No. 46/119, 17-12-1991. “Principles for the Protection of persons with Mental Illness”, United Nations.
.Vahia et al’s early study (1974)
.Verghese, Gupta & Prabhu, 1968)
.White paper (2000) on the “Protection of the human rights and dignity of people suffering from mental disorder, especially those placed in a psychiatric establishment” drafted by the Working Party of the Steering Committee on Bio Ethics (CDBI), Council of Europe.
.Wiseman, B. (1995) Psychiatry: The ultimate betrayal. Freedom Publishing Co. A Publication of Citizens Commission for Human Rights, LA, California.
.World Health Report, (2001) Mental Health. World Health Organisation, Geneva.
.WP (Civil) No. 257, 1998, Collossa vs. State of Goa in the High Court of Mumbai.
.Writ Petition No. 562/2001 in Saarthak vs. Union of India in the Supreme Court of India.

CIA, brainwashing and electroshock therapy

‘Monster’ Scot paid by CIA to brainwash patients

EAMONN O’NEILL October 19 2004

UK Herald

A MAVERICK Scottish doctor conducted inhuman experiments funded by the CIA using LSD and electro-shock therapy to brainwash unsuspecting patients, a documentary will reveal tonight.
Dr Ewen Cameron, from Bridge of Allan, Stirlingshire, believed he could wipe the mind clean of “bad” thoughts with a combination of electricity and a cocktail of powerful drugs.

His experiments in Canada in the 1950s were funded by the CIA, which wanted to see if his methods could be used to help agents withstand hypnotism and other brainwashing techniques.
By 1951, his research ex-panded to help find out how brainwashing a captured enemy spy might help “turn” him to become a double agent.

The first experiments were conducted on animals. Sometimes drugs such as LSD – then seen as a wonder drug – were used. Eventually, humans were targeted and more often than not the victims were unwitting participants in medical trials which lasted 25 years and cost American taxpayers £14m.

Dr Cameron died in 1967 during a climbing expedition, but his work left many hundreds of his “guinea pigs” with their memories almost completely wiped. The CIA programme did not come to light until 1977.

Now, five decades after treatment, many of his patients are still looking for compensation.
Gail Kastner, 70, a Canadian, was 19 when she was taken to the Allan Memorial Institute, a psychiatric unit near Montreal. After being subjected to shock treatment by Dr Cameron, she regressed to her childhood and began behaving like a baby.

Speaking on BBC Scotland’s Frontline programme tonight, Ms Kastner is scathing of Dr Cameron: “He used and abused his power horribly, and I hope he met a very bad ending and suffered, as he made other victims suffer knowingly.”

Still with no memory of her life before the age of 19 and badly affected by her ordeal, she said: “I have nightly nightmares where I wake up screaming.”

It was later shown that Ms Kastner had received electroconvulsive therapy from Dr Cameron at levels which had been previously administered only in laboratory experiments on dogs, which later had to be put down.

Dr Cameron qualified at Glasgow University in 1924, and was seen as one of the world’s leading psychiatrists when he began his controversial work and went on to become first president of the World Psychiatric Association.

In his drive to find a cure for mental illness, he used techniques developed by Nazi scientists in the second world war.

While some studies were legitimate, many were secret tests of interest only to the CIA, whose funding of Dr Cameron and use of the results of his experiments did not emerge for decades.

What the intelligence agency paid for were tests carried out on patients unaware that they were part of a CIA study, or that the results were being evaluated for secret military defence purposes.

Dr Cameron never acknowledged that he had broken the golden rule of medical experiments on humans – informed consent.

During the Nuremberg trials, this was the very point which convicted Josef Mengele, the Nazi doctor dubbed the Angel of Death, and others who subjected innocents to appalling medical procedures.
Many victims tracked down by Frontline refused to participate in the documentary because they were too ill. The family of one victim said “he has become like a hermit. He has trouble remembering anything”.

He was one of 77 victims who, in the mid-1990s, were paid just £55,000 in compensation by the CIA and the Canadian government – who, it was shown, were also complicit in the medical trials.

Ms Kastner, who only had her compensation claim settled this year, said of the mild-mannered doctor who destroyed her life – and that of countless others – in the name of science and military advancement: “He was a monster.”

Informed Consent Forms and patient brochures

The issue of informed consent is a hot one. The problem with the informed consent statements that exist today is that they just aren’t honest. They gloss over the main points about ECT – that’s it is a temporary fix, and that memory/cognitive damage *does* occur.In a continuing education course for ECT practitioners, Max Fink tells participants they are legally safe by using the informational pamphlets from the ECT machine manufacturers, plus videotapes (he does go a little bonkers in self-love, envisioning himself a TV star – kind of comical).

If you can write in your chart that the family saw the Mecta booklet, “you’re home free” legally, says Fink, in advising these guys on how to protect themselves in case of lawsuit.

That’s what’s important – protection. Fink goes on to explain how to “save yourself the hassle of consent.”

This audio clip requires the Real Player

Here are some examples of informed consent forms and informational booklets given to patients.

First, read what a doctor who runs informedconsent.org has put together as a model informed consent form. This eye doctor says: “So that I may clearly state the content and conditions of my consent to permit medical and surgical procedures, I write my orders at home and bring them to the treatment facility. My orders override any and every blanket consent form I am asked to sign. Make them a permanent part of my medical record and provide me the following choices:” and then goes on to list everything in detail. I suggest that if you or a loved one is considering ECT, you adapt this kind of language into your own consent form and insist on these measures. This will make YOU a truly INFORMED consumer, and not just a submissive patient at the mercy of the powers that be.

From Fletcher Hospital in Vermont, the informed consent form on ECT. Begin here.

Also from Fletcher, the form used when beginning maintenance ECT.

From the American Psychiatric Association, a sample consent form.

From Dr. Richard Abrams, a sample statement from his book “Electroconvulsive Therapy,” the bible for ECT practitioners. Abrams explains how to reduce your risk of litigation. (if you’re an ECT doc)

Here is a copy of the Somatics (Abrams’ company) brochure for patients. Please do NOT take this as serious information about ECT. This is what Somatics (leading manufacturer of ECT machines and accessories) gives/sells to doctors/hospitals who do ECT. What Abrams writes in this brochure to patients and families is not even close to what he tells doctors. If in the brochure, he says 2 plus 2 equals nine, in his book to docs, he says 2 plus 2 equals four. One of these days I’ll try and put up a lengthy critique, but you can do it yourself if you read the literature and compare it to what this brochure says.
Outside
Inside (sorry about the coffee stains…I use it as a coaster sometimes – hey, at least I don’t use it as TP!)

Last Resort Therapy

Last Resort Therapy


The Record (Bergen County, NJ)

10-25-2005
Jennifer Hughes

CORRECTION: An article about electroshock treatments that appeared in the Oct. 25 Health section incorrectly reported the name of the founder of the Committee for Truth in Psychiatry. The group was founded by Marilyn Rice. (PUBLISHED THURSDAY, NOVEMBER 10, 2005, PAGE A02.)

When most people think of electroshock therapy, they picture Jack Nicholson writhing in agony on a gurney in “One Flew Over the Cuckoo’s Nest,” but “Jane” has never seen the film.

The 52-year-old doctor from Morris County, reluctantly agreed to ECT (the procedure is now called electroconvulsive therapy) in February after her 30-year battle with manic depression had reached its terrible crescendo.

Medications no longer worked and the cocktail of drugs brought nighttime insomnia and daytime drowsiness. Tremors shook her hands, she gained 50 pounds, and her sex life evaporated.

“I don’t like to think about it, but I was really suicidal,” said Jane, whose mother is institutionalized with severe depression. Since then, she has had 16 treatments at University Hospital in Newark and said her lifelong depression has lifted.

“It basically saved my life,” she said.

ECT, which causes a grand mal seizure, has changed since its early days, when even proponents agree it was used on too many patients, in painful procedures. Now, patients who receive ECT are given anesthesia and muscle relaxants, which prevent broken bones and muscle injuries. The amount of electricity in most ECT treatments is about 800 milliamps, about one-fifth the power you would feel if you were shocked through your wall socket, doctors said.

Many psychiatrists admit memory loss is a serious potential side effect of ECT, but the treatment is often the last resort, when medications don’t work, for people who are severely depressed.

“ECT is the gold standard by which all anti-depression treatments are judged,” said Dr. Charles Kellner, who treated Jane. “It works better and faster than any other treatment.”

At Englewood Hospital and Medical Center, Dr. Charles Blackinton said those referred for ECT often can’t take drugs because of medical conditions or can’t tolerate the side effects.

“People are no longer willing to put up with partially remitted depression,” said Blackinton, who has been doing ECT at the hospital since 1964.

But while ads for anti-depressants are commonplace on TV, ECT has not escaped its association with psychiatry’s dark ages. Jane asked to remain anonymous because of the stigma.

ECT also has not shed its vocal critics, who insist success rates are overblown, that memory loss from ECT is more widespread than reported and that it is often irreversible.

“Neurologists are trying to prevent seizures because of the bad things that they do to the brain, while psychiatrists go out of their way to produce seizures,” said Dr. Peter Sterling, professor of neuroscience at the University of Pennsylvania School of Medicine. “It doesn’t make any sense to me.”

Despite the fact that ECT has been used in the United States for more than 50 years, no one knows exactly how it works or how many patients receive it each year.

The American Psychiatric Association estimates 100,000 patients get ECT annually – but doctors admit the figure is merely a guess because no government agency or outside group monitors or tracks ECT nationwide.

Englewood Hospital has seen a rise in ECT patients; from 142 in 2003 to 168 for the first eight months of 2005. At the University Hospital, which has had an ECT program for 2 1/2 years, about 26 patients have undergone ECT each year, including some who came from as far away as California.

While several states have laws that require reporting information on ECT patients, New Jersey does not.

Linda Andre, a freelance writer in New York City, founded the Committee for Truth in Psychiatry in 1984 to cope with her negative reaction to ECT.

She said she was coerced into ECT by family members. She said she has no memory of ever being depressed and that the treatment wiped out five years of memories.

“Your life is erased like it never happened. … It can be very difficult to live your life after that,” she said. Andre said her group has about 500 members nationwide, and all of them have experienced severe side effects from ECT.

She said she often hears former patients say doctors don’t adequately explain side effects and push people into the treatment.

One of the biggest hurdles Jane had to overcome before she agreed to ECT was the fact that her doctor couldn’t explain how it worked.

“I’m a scientist,” she said. “That was very hard for me to accept.”

It is not the electricity but rather the seizure caused by ECT’s current that is believed to be the key, said Kellner. One theory is that when the body releases neurotransmitters to “turn off” the seizure, those are the same brain chemicals that naturally help alleviate depression.

Backing up that theory is the fact that many of the most recent and most effective anti-depression drugs were first developed as anti-convulsants, Kellner said.

Dozens of studies have been done on ECT’s effectiveness with a wide range of success rates.

* In a 2005 study, 85 percent of patients reported a remission in their depression during ECT treatments and within a week of the course’s conclusion.

* Another study, from 2004, reported between 30 and 46 percent of patients interviewed within days of ECT reported that their depression had lifted.

* A 2001 study found that without follow-up medication, depression returned in 85 percent of patients within six months. Only 39 percent reported a relapse if they had medications.

ECT is a short-term solution, said researcher Dr. Vaughn McCall, editor of the Journal of ECT and the president of the Association for Convulsive Therapy, which has about 400 members worldwide.

“The first thing you have to do with a patient is disabuse them of the idea that this is a cure,” McCall said.

Just because ECT helps only in the short term does not mean it should be discounted, argued Kellner.

“If someone kills themselves because they couldn’t get well in the short term, then it doesn’t matter what would have worked in the long term,” he said.

ECT can pull a patient from the depths of a life-threatening depression quickly and long enough to allow time for medications to work, to find a proper cocktail, or to allow for a natural lifting of depression, McCall said. In some cases, patients rely on a “maintenance” ECT – having the treatments spread out for years.

“There’s no good answer for why drugs sometimes work after ECT when they didn’t work before,” said Englewood’s Blackinton.

Dr. Peter Breggin, author of the book “Toxic Psychiatry,” is likely the most well-known critic of ECT. He said the reason some patients show an improvement after ECT is precisely because of the damage caused to the brain.

“Patients are too numb, bewildered and confused to be anything, let alone depressed,” he said.

The other major hot button issue of ECT is memory loss. Supporters of ECT say memory loss is usually not permanent or extensive and generally involves impersonal memories like names of places.

“There are some reports of people with much more profound memory loss … we don’t understand why this happens, but it is quite rare,” said Kellner.

Critics say studies are tailored to weed out severe cases, and there is not enough follow-up on patients to give a real understanding of effects.

“All the studies are done by shock docs,” said Breggin. “I’d discount anything they have to say.”

In one study from 1986, patients wrote down an inventory of personal information and memories before ECT treatment and were asked the same questions again post-ECT.

Those with bilateral ECT – when electrodes are placed on both sides of the head – had forgotten about 30 to 40 percent of the information. Patients in a control group who did not have ECT forgot about 15 to 20 percent of the information.

Because of the problems with memory loss, researchers are looking for ways to induce seizures, or create similar brain chemistry, without electricity.

One way is through magnetic stimulation, which produces seizures in a more localized, specific part of the brain, said Dr. Sarah Lisanby, a researcher and practicing physician at Columbia University. Another technique is called Vargus Nerve Stimulation, which uses a small device implanted in the body that stimulates a nerve running through the neck to the brain.

One of Sterling’s arguments against ECT comes from how researchers are trying to promote these new treatments.

“In order to promote them, they’re pointing out the damage caused by ECT, the fact that it is safer than ECT, even though they had denied for years that ECT caused damage,” he said.

Lisanby noted that while ECT can have serious side effects, so do psychiatric medications.

“I’d like to see us as a field do a better job of communicating more accurate information about the benefits and risks of ECT as compared to other treatments,” she said. “I think that could help combat some of the stigma and lack of information on what ECT is.”

(SIDEBAR, page F01)

What the procedure entails

Most patients who have ECT have a course of therapy that includes six to 12 treatments, starting with three times a week.

* A patient who is referred for ECT undergoes a physical exam to ensure there is no neurological problem that could be causing depressive symptoms. Blood tests and spinal X-rays are taken to ensure the patient can tolerate the anesthesia and seizure caused by ECT.

* Doctors explain to the patient and family members side effects, including memory loss and cognitive difficulties. They are advised to have someone help at home after treatments, to refrain from driving, and to avoid major decisions.

* At the hospital, monitors are placed on the patient to track blood pressure, heart rate, oxygen content and brain waves. Gauze is inserted into the person’s mouth to prevent tooth damage. A general anesthetic is administered, and the ECT electrodes are placed on the scalp. In bilateral ECT, one is placed on each temple; in unilateral ECT, the electrode is placed on the top of the head near the right side.

* The electrical pulse lasts from half a second to eight seconds, and the patient undergoes a grand mal seizure, which can last from 25 seconds to 90 seconds. In many cases, because of the muscle relaxant given, the patient’s body barely moves.

* Once the patients awaken, usually after less than 10 minutes, they remain in a recovery area until they can be driven home or return to a psychiatric unit of a hospital.

Source: Dr. Charles Blackinton, Englewood Hospital

Paper on ECT statistics at MH Stats Conference

This is an outline of a paper I gave at the 2001 Mental Health Statistics Conference (SAMHSA) in Washington, DC.

ECT Reporting – The Statistical Gap

Shortly before she left office as SAMHSA Director, Dr. Nelba Chavez spoke of the pockets of mental health research that existed. These were pockets of good, solid research, but she encouraged those in the field to push on and to try to close the enormous gaps that exist in research today.

The field of electroconvulsive therapy, or ECT, is littered with chasms where research simply does not exist. This paper will highlight those gaps, as well as propose new directions for ECT research.

The most basic question, how many people have ECT each year in the US, is not answerable. Researchers can estimate, and these estimates generally range from 100,000 to 200,000 persons per year. But precise numbers continue to evade us, and the last major study to undertake the question of how many patients in the US receive ECT annually was published in 1994. This study, “The Use of ECT in the United States” by JW Thompson et al, used estimates from the NIMH Sample Survey Program for 1975, 1980 and 1986 to conclude that ECT use dropped dramatically from more than 58,000 in 1975, to an estimated 36,558 patients in 1986.

A study in 1995 by Hermann used data from the American Psychiatric Association’s 1988-1989 Professional Activities Survey to estimate ECT use in 317 metropolitan statistical areas. Annual ECT use varied from 0.4 to 81.2 patients per 10,000 population.

While this was a engaging study, it relied entirely upon those APA members who responded to the survey, and their 4,398 patients treated with ECT. The authors concluded that the estimated national rate of ECT utilization would be 4.9 patients per 10,000 population, resulting in an estimate of 100,000 US patients treated with ECT in the year studied, 1988-89. So the first study concluded 36,500 patients were treated with ECT in 1986, and the second study estimated 100,000 patients treated two years later. It seems unlikely that the use of ECT in the United States would nearly triple in two years.

Thus, we come back to the question, just how many persons are treated with ECT each year? The answer is we don’t know.

This illustrates what many consider to be the biggest problem in contemporary ECT research – the lack of real data. There is no lack of research on ECT, with two professional journals devoted entirely to the subject. But as Dr. Chavez pointed out, the research exists in pockets. One of the biggest areas of research involves the continuing quest to prove the mechanism of action, just how ECT works. Despite millions of dollars and countless hours of research, a definite answer continues to elude scientists.

A few states have enacted legislation to help answer this question – and others. Those states include Massachusetts, Illinois, Vermont, Colorado, California and most notably, Texas. Two weeks ago, the Missouri State Senate rejected a statewide ECT reporting bill, calling it too controversial.

Indeed, the legislation passed in Texas has seen opposition along the way. The statute in Texas goes beyond mere reporting to include restrictions on the use of ECT on anyone under age 16, as well as limiting the number of treatments per patient, requiring a second opinion when used on the elderly and tighter control of involuntary ECT.

Many ECT practitioners and proponents fought the reporting law, but a report written by three prominent Texas psychiatrists last year called it  source of valuable data and recommend a continuation of the reporting requirement. And, they call for additional rating instruments, including a patient self-report rating scale for symptom severity and memory impairment, as well as a longer follow-up period. Currently, Texas only requires a four-week post ECT follow-up.

How many people die annually from ECT? The American Psychiatric Association reports a figure of 1 in 10,000. While the Texas statistics don’t show a clear number since cause of death isn’t listed, a review of autopsy reports indicates a rate of closer to 1 in 450. Of course the state of Texas is not representative of the rest of the country because of its tighter regulations. Researchers should have better data than this. Having no way of knowing accurate numbers of patients treated each year, or the number of complications – this is unacceptable from a scientific standpoint.

There are several other areas of interest that arise from an analysis of the Texas data, including the high use of bilateral ECT, approximately 82 percent. This number conflicts with the widely-touted viewpoint that unilateral is used more often today because it causes fewer side effects.

We come back to the idea of pockets of great research, with enormous gaps we need to fill.

The wealth of data gathered in Texas over the last several years should be a model for a federal reporting system of ECT. Last summer, the National Mental Health Association announced in its policy statement that it advocates the establishment of a national data bank, operated under the oversight of the Center for Mental Health Services, requiring the scrupulous recording of all ECT given, with documentation and dissemination of results.

So the first order of business must be such a database and a federal ECT reporting law.

A second area of research that must be addressed is the area of memory research. There exist a variety of studies that examine memory issues in ECT patients. However, critics insist that the measures of memory loss are superficial and ignore major components of the system of memory.

Writing in Nature last year, neuroscientist Peter Sterling says: “Memory loss could be monitored by questioning patients before ECT about early events in their lives and then re-questioning them following each series of ECT. When this was done 50 years ago, memory losses were marked and prolonged. However, no effort has been made since to routinely perform this simple test.”

That study fifty years ago was done by Irving Janis, and remains the definitive study of the effects of ECT on memory. Janis interviewed 19 patients at length, and then interviewed them four weeks after ECT, attempting to obtain the same information. He gave the same interviews to controls who did not have ECT. Janis wrote “Every one of the 19 patients in the study showed at least several life instances of amnesia and in many cases there were from ten to twenty life experiences which the patient could not recall.”

Studies undertaken in the 70s and 80s added to Janis’ findings that ECT does, in fact, produce memory loss.

But contemporary researchers continue to maintain that ECT does not produce permanent memory loss and that such reports are either the result of patient misunderstanding, or the effects of the depression and not the ECT.

This has caused a great chasm between researchers and persons who identify themselves as ECT consumers and survivors. Even those who say they were glad they had ECT complain of memory loss and say they wish they had been told of the risks upfront.

Since the beginnings of ECT use, patients have complained of cognitive impairment and those complaints have remained consistent through present time. ECT patients and survivors alike have asked researchers to focus more upon these issues, but are told “it’s all in your head” and their complaints dismissed.

Anecdotal reports of success are welcomed and even published, yet the large body of anecdotal reports that focus upon the negative side of ECT are discarded, saying that anecdotal reports are not valid.

One of the biggest problems with the memory studies as performed today is that they do not use sensitive and elaborate testing, such as those used by de Mille to differentiate matched subgroups of fifty patients who were lobotomized in the 60s. Many so-called memory tests today simply use the Mini Mental State Exam to prove that no deficits occur. Critical researchers say it’s not difficult to find, but you must test for it, and they continue to say that contemporary studies are deliberately not testing for deficits they know will appear. In the study of permanent effects of ECT, testing such as that of de Mille should be made at intervals of a day, a week, a month and a year post-ECT.

Let’s return again to the Texas data.

I’d like to hand out the actual reporting form that is used in Texas.

There have been two major journal articles that have analyzed the data, one in the Journal of Forensic Sciences November 2000; the other in Journal of Clinical Psychiatry in 1998.

(quotes)

This does illustrate the problems associated with the treating ECT physician deciding for the patient and often not hearing any complaints. As you can see from the form, the doctor simply chooses a number from one to five. One of the journal authors does go on to suggest a patient self reporting form, and this would be a strong addition to the current collection of data.

(subjective nature of severity and memory impairment)

A federal database of these kinds of data would be extraordinarily valuable in providing tools with which researchers could evaluate ECT, and examine trends.

Consumer/survivor input into research studies is needed so that the issues that are important are no longer ignored. A research panel that is made up of consumer/survivors should be established, and it should direct some of the research. It should go beyond an advisory capacity and encourage consumer/survivors to lead the way and begin to research the issues that concern them.

As the saying goes, nothing about us without us and that saying applies to research. More than sixty years of being told “it’s all in your head” must change and consumer/survivors need access to research funds, as well as the accommodations necessary to give them the tools they need to perform valid, scientific research…concerning the issues that affect them.

Some very strong efforts are being made to include consumer/survivor voices in policy decisions, but an equal effort must be made in the research arena.

Another of the criticisms directed at ECT researchers is that the bulk of the research is conducted by the same group of people. They sit on the editorial boards of the journals and some have financial interests in the manufacturing companies. Allowing consumer/survivors a voice in these research projects, as well as the opportunity to provide some outside direction could help in overcoming some of the criticisms.

However, barring full inclusion into the research process, ECT consumer/survivors should be given the resources to do their own research, on those issues they feel have been continually ignored.

Animal studies are a third area of concern in the realm of ECT research.

The majority of studies on the effects of ECT on animals were done in the 40s and 50s. Numerous authors have called upon these studies as evidence that ECT does cause brain damage. Contemporary researchers dismiss the studies, saying they were done 50-60 years ago and are no longer valid due to problems in methodology and due to claims that the process of ECT is substantially different today. Yet researchers are not attempting to do similar studies using more modern machines and better scientific methods.

A review of Medline citations that involved the study of ECT and animals returned thousands of citations, leading at first glance to the belief that animal studies are being conducted. However, closer examination reveals that the criticisms are valid. The animal studies involve almost exclusively the continuing quest to discover how ECT works.

Surely some of this research money could be used to repeat the studies of earlier decades. Until a major animal study similar to that of Hans Hartelius in 1952 and many others like his, the disagreement will remain and the question never fully answered: Does ECT cause brain damage. Both sides of the controversy remain steadfast in their views, but good, solid animal studies are needed before the truth will ever be known. And to deflect the criticism that will definitely result from both sides, depending on the outcome, I would like to see several large, multi-disciplinary studies involving large animals, bringing in experts from outside the field of ECT.

ECT isn’t the only area where there exist research deficits of course. But it is very illustrative of an area of research that is closed to outsiders and where any criticism is continually deflected, despite six decades of consistent complaints.

And that brings us to the topic of anecdotal reports, a very problematic area for researchers.

When the FDA classified ECT devices in 1979 as the most dangerous and demonstrating an unreasonable risk of illness or injury, the American Psychiatric Association heavily lobbied the FDA to reclassify the machines as safe. The original classification would have required the industry to perform animal testing and prove its safety. However, ECT survivors organized and also lobbied the FDA. This resulted in over 1000 anecdotal reports to the FDA.

Because complaints are not taken seriously by ECT researchers, and never have been, anecdotal reports such as these are disregarded, saying they are not scientific evidence. However, it’s a Catch-22.

Patient complains and the treating physician dismisses the complaints saying the patient is either mistaken or so mentally ill, she doesn’t know what’s going on. In that way, the ECT industry has managed to disregard decades of complaints.

Kalinowsky and Hock wrote in their 1952 textbook that “All patients who remain unimproved after ECT are inclined to complain bitterly about their memory difficulties.”

The trend today has been to accept a few token stories about memory loss, provided the person says ECT saved my life. If the entire report is negative, i.e. it didn’t help and left me with damage, it goes back to the person being too mentally ill to understand what’s going on, or worse, simply a liar and troublemaker.

Additionally, anecdotal reports are acceptable when written as case reports, or  when promoting the value of ECT. All of a sudden they count. Yet when ECT survivors try to draw upon their own experiences, you hear “Those are anecdotal and don/t mean anything.”

I’ve lost count of the anecdotal reports that I receive in email via the website I run. Obviously those can’t be said to be representative of the overall population of ECT users, but I do believe there is value in anecdotal reporting, especially when it seems that complaints will be continually ignored. Although I’ve never actually tabulated the emails I’ve gotten over the last few years or tried to count who had what, the majority of them talk openly about the devastating memory loss, the lack of resources for recovery, and dismissal by their doctors – even when they say ECT saved my life.

When I did a small study called Voices a few years ago, I was stunned to find that many patients become frustrated after ECT and their doctor’s rejection of their complaints…so frustrated that 75 percent of those – even those who reported good outcomes with ECT’s relief on depression – have moved on to a new doctor. Some of course left psychiatry altogether, but the majority became so angered that they found new doctors.

So we come back to the issue that there are all of these self reports and very few are listening. The FDA has its collection of reports that resulted when they considered reclassifying the devices. But I’m not sure that the role of the FDA as a regulatory agency is the most appropriate place to collect oral histories and anecdotes.

What I would like to see is a central database where people can share their stories, good and bad. It’s important that all voices be heard and that no one’s story be rejected or ridiculed. It’s an idea I’m considering on my own, simply because it needs to be done….kind of an ethnography of electroconvulsive therapy patients.

Finally, a lack of research in the area of recovery troubles me the most and it should be a priority. The needs of ECT patients are unique – not only do they have to continue the quest to keep depression away, they have needs that are not recognized by most.

The most common complaints after ECT are:

Inability to remember learned materials, and difficulty in relearning, or in learning new skills
Inability to concentrate on the job
Amnesia

There are many anecdotal reports of persons who had thriving careers, but post ECT have forgotten their skills.

There must be recognition from the medical and support communities of these problems, as well as research into recovery methods.

As it is, ECT patients use a system of trial and error, finding techniques that work. Sometimes they connect with others and share ideas.

I compare the recovery process to that of someone who has lost a limb. Once the deficits are recognized and accepted, the person must find ways of coping and find ways of favoring areas of their thinking processes that have not been affected. When a person loses a limb, it takes time to adapt and to find ways of managing without that limb. Eventually, the person learns to work around limitations and to find methods to assist in getting back to everyday life.

There are areas in ECT research where problems are still not recognized, despite 60 years of consistent reports and complaints. We must begin to recognize and accept that these problems do exist before we can take the necessary steps to correct the deficits in research.

As a beginning step towards data collection and better understanding of this complex issue, we need a reporting bill similar to that in the state of Texas, and we need it on a federal level. This is something that both sides of the controversy can sign onto and the very idea of a reporting bill should not be controversial. It should be matter of fact and acceptable to all.

Second, we need to address the gaps in research studies in the area of animal research and the effect of ECT on the brain. These studies should be done by a team of researchers that include scientists from outside the field of ECT, using experts from the field of neuroscience.

Third, we need to do a better job of studying memory deficits, and not limit the research to superficial testing. The testing should be rigorous and should also include researchers from outside the field of ECT who fully understand the complexities of memory.

Fourth, we must find a way to compile anecdotal reports to give credibility to the unheard voices of ECT. Instead of ridicule, ECT consumer/survivors demand respect for their experiences, and they deserve to be heard. This information must be made easily available to those considering ECT so that they’ll have a variety of viewpoints upon which to draw and make a more informed choice.

Fifth, we need to find ways to encourage independent consumer/survivor research, to bring together mentors from the research community and to drive research in areas that reflect consumer/survivor values.

Finally, we need to commit resources to the study of recovery for ECT patients. We must recognize the unique needs and find ways to provide rehabilitation and tools for recovery.

WINNER: Max Fink, the grandfather of American ECT


fink.jpgGrandpa Max used to claim that ECT worked by causing brain damage. He argued for years that the therapeutic effect from ECT is produced by brain dysfunction and damage. He pointed out in his 1979 textbook that “patients become more compliant and acquiescent with treatment,” and he connected the improvement with “denial, disorientation,” and other signs of traumatic brain injury and an organic brain syndrome.

Fink was even more explicit in earlier studies. In 1956 he stated that the basis for improvement from ECT is “cranio-cerebral trauma.” In 1966, Fink cited his own research indicating that “there is a relation between clinical improvement and the production of brain damage or an altered state of brain function.” He does not, however, make such statements in public, in court, or in the 1990 APA Task Force Report.

Max has also been busy with other ventures. Born in 1923, he is currently professor (emeritus) of psychiatry at SUNY at Stony Brook. His CV is too long to list here, but here are a few interesting appointments:

Founding Editor, Convulsive Therapy
Consultant to the FDA
U.S. Army on the Feasibility of Using Incapacitating Agents Against Terrorists.
Captain, U.S. Army.

The Finkeroo owns a company called SciData, based in Atlanta, Georgia. Organized in 1967, the last year’s sales were listed at $170,000.

Fink helps out his buddy, Richard Abrams, with Somatics, Inc. He narrates Abrams’ videotapes for Somatics, Inc., which sell for $350 to health professionals, or $360 for patients and families. Or you can buy a “preview version” for $25.

Max has a habit of being a little less than honest at times.

For example, he is responsible for the famed 1 in 200 statistic, which the APA uses in its literature. This statistic, long criticized by ECT advocates and survivors, supposedly reflects the number of patients who suffer memory loss. Recently, Max admitted the number was *not* based on any scientific studies, as had been widely claimed, but rather, was an “impressionistic” number – meaning he made it up.

Here’s another example, in a post of his from the shock doc mailing list:

“2. The second question is how to achieve an effective treatment in the face of the limited output of brief-pulse devices. The usual approaches are to use bilateral placement; change anesthetic from methohexital to etomidate; determine the dosing of benzodiazepines and if these were used, block with the antagonist flumazenil; enhance seizure duration by either caffeine or theophylline; and when these fail, double stimulation. If the lack of adequate energy is a frequent issue in practice, the THYMATRON can be modified to the British version, or the MECTA can have the Sackeim modification added — for research purposes.” For research purposes, Max??? That’s his way of covering his butt. He’s telling other shock docs how to boost the juice way past the machinery’s capabilities….for “research” purposes. This post was in response to a query from another doctor with legitimate patient concerns.

Max also doesn’t take confidentiality very seriously. He’s often harassed a certain ECT survivor, shutting down question and answer periods when she arrived. But he’s gone beyond that, by shouting at her and telling the entire workshop medical information from her confidential medical records.

All in the name of science for Max Fink.

Here is an example of his condescension towards mental patients: during a session on ECT for doctors, a doctor is explaining a patient he has who is afraid she’ll die if the machine shuts down, and the need for backup batteries. Max finds this to be a chuckle.

Max Fink chuckles at patient’s fears

He also sees himself as a celeb of sorts, illustrating how “fans” approach him after seeing his old video.

I’m famous and mobbed by my fans

Reporters are frequently invited by Max Fink to witness patients being given the treatment. Psychiatrist Peter Breggin has urged him to allow them to see his patients *after* they have received a full course of shocks. Under pressure, Fink agreed, but with a catch. While he charges nothing for the media to watch a patient undergo the procedure, he decided to charge $25,000 for himself and $15,000 for the patient for a single interview with the patient awake after a course of ECT.

This old goat needs to be put out to pasture….

ELECTROSHOCK: A CRIME AGAINST THE SPIRIT

Spring 2002 (pp.63-71)
Ethical Human Sciences and Services: An International Journal of Critical Inquiry

This is another exquisite article by my friend Leonard Roy Frank.

Download pdf: ELECTROSHOCK: A CRIME AGAINST THE SPIRIT

Review of Consumers’ Perspectives on Electro Convulsive Therapy – SURE

The SURE – Service User Research Enterprise – report on consumer views in the UK.

Download PDF file (1.2 mb) consumerperspectives.pdf

Voices From Within: A Study of ECT and Patient Perceptions

By Juli Lawrence

Abstract:

This study examines ECT (electroconvulsive therapy) patients’ own perceptions concerning their treatment and after effects. Research concerning memory loss and cognitive problems as a result of ECT has focused on researchers’ ideas about what is important in assessing memory loss and cognitive damage. This study is an attempt to give ECT patients and survivors a voice of their own, from the perspective of those who have experienced the treatment.

Contents

Introduction
Review of the Literature
Background, Research Methods
Analysis
Conclusions

Introduction

This study resulted from repeated patient complaints that memory deficits and cognitive disturbances following ECT are not being acknowledged by doctors and researchers. The study contains the viewpoints of 41 subjects who have undergone ECT treatments.

Failure to record patient views is a fundamental flaw in all previous research. Patient views are dismissed by many practitioners, who contend the patients themselves do not understand true memory deficits, or by claiming that the memory problems result from underlying depression, and not ECT. From the perspective of many patients, it is those experts who do not fully understand memory and how severely it can be affected by ECT.

This study demands attention by those experts who use ECT in their psychiatric practice. One of the most important findings in this study is that patients who feel they have been damaged by ECT do not return to the doctor who performed ECT and discuss the problem. Instead, feeling that they have suffered side effects that were unanticipated, they simply go on to another doctor, or leave psychiatric treatment altogether. This is not to be seen as an indictment of the patient. It’s quite normal that someone who feels s/he has been misled or even lied to would not return to the offending doctor, particularly when the patient feels s/he’s been abused.

Thus, when ECT practitioners claim their patients don’t complain, they may be telling the truth, based on their lack of follow-up with patients who have left their care. The patients who have had disastrous experiences never return to inform them, and therefore, they never know.

Additionally, when patients do try to discuss these problems with the doctor, their feelings are often dismissed as being mistaken or a misunderstanding.

This study is an attempt to identify areas of concern among ECT patients, and to give previously unheard voices a chance to speak out. It is also intended to make clear that there are effects that the established ECT community does not want to acknowledge.

Review of the Literature

The literature concerning effects of ECT, including possible brain damage, is biased in favor of ECT. At a recent conference comprised of mental health researchers (45th National Conference on Mental Health Statistics, held in May 1996 in Washington, DC), this concern was posed to researchers in the field. Researchers from universities and the National Institute for Mental Health acknowledged the lack of unbiased research in the field of electroconvulsive therapy, and stressed the need for future independent research.

A full listing, with abstracts, of the literature reviewed is available upon request.

The author reviewed over 500 articles and abstracts from 1966 to present on ECT using Medline.

A current trend in ECT research is evaluating the use of various drugs and herbal substances along with ECT, in attempts to reduce memory loss.

Of 50 articles on ECT since 1986 that discussed memory and cognitive deficits, only eight actually addressed the issue of memory loss. One article reviewed the benefits on memory of unilateral vs. bilateral techniques. Six discussed the varying brain and chemical changes that occur during ECT. Four evaluated trends in ECT over the past decades. The remaining 62 percent (31 articles) focused on using different chemicals (caffeine, calcium channel blockers, ginseng, and so on) during the treatment to reduce memory loss and other negative side effects. Additionally, of those 50 journal articles, 15 were rat and mice studies.

Of those eight that reviewed memory loss and cognitive deficits, only one was based on the presumption that such problems do, in fact, exist. (Durr, 1995) This was from a nursing journal, suggesting that those who deal the most with patients on a continued basis accept that disturbances do occur, despite practitioners’ continued assertions to the contrary.

Two of the articles concluded that ECT treatments actually improved memory and cognitive functioning by eliminating the underlying depression (Frith, et al, 1987; Reid, 1993) The remaining articles tested ECT recipients against normal controls and depressed patients, concluding that any memory and cognitive problems were temporary. One study compared 15 depressed patients, 17 in remission from depression, 20 normal control subjects and 15 in remission as a result of ECT. Although this study showed impairment two weeks after ECT, at six months, no problems were reported. (Williams, et al, 1990)

Finally, one article did discuss the more severe problems associated with bilateral versus unilateral treatment and urged clinicians to take into account the non-memory cognitive effects of bilateral treatment, and to inform patients of these problems prior to consent. (Calev, et al, 1995)

In a 1983 study (Squire et al, 1983), researchers examined self reports of memory problems in patients receiving both unilateral and bilateral ECT, and among patients with depression who received other treatments. The patients who did not receive ECT did not report any memory problems seven months after hospitalization. Compared with bilateral ECT, those who received unilateral ECT reported minor memory complaints. Half of the patients who received bilateral ECT reported poor memory three years after their treatments.

An extensive search of the literature conducted by the author revealed little information on patient views. One study compared 26 patients who complained of permanent, unwanted effects against two control groups. Subjects were given a battery of 19 cognitive tests. The significant differences among the complainers were mostly attributed to depression and medication, not to the ECT treatments. However, some impaired cognitive functioning was seen as a result of ECT. (Freeman et al, 1980)

Background, Research Methods

This study arose from concern that the voices of ECT patients were not being heard. The common complaints of sustained memory loss, cognitive learning difficulties and other effects after a series of ECT, are often met with contempt from the psychiatric community. The medical establishment contends that such effects simply do not occur; they are the result of the underlying depression, or are simply “misunderstandings” by the patients.

In January, the author sent out surveys asking questions about individuals’ experiences with ECT. The survey was posted across the Internet in newsgroups, mailing lists, on-line services, bulletin boards and by word of mouth. In addition to posting the survey in mental health related areas, it was sent to several non-mental health newsgroups and mailing lists. (The original survey is available upon request.)

Problems in sampling methods

Obviously, a perfect sampling of ECT recipients is not possible. Confidentiality prevents the non-medical researcher from access to lists of patients, and this was one way of securing responses.

In true representative sampling, the sample must be representative of the target population in order for any inferences to be valid across the entire population. Past ECT studies are no different than this study in that respect. Researchers make claims that ECT causes no permanent damage, based on a sample of perhaps 10 or 20 subjects. These subjects are treated at the same time, in the same hospital, by the same doctor. And because they have continued treatment with the same treatment team, one would assume that they were satisfied with treatment.

The Voices study does not investigate any one patient from a particular doctor, a particular area of the world, or one moment in time. Rather, it looks at a variety of patients who have had ECT treatment in a variety of locations, different doctors, and different time periods. Surveys were received from patients who had undergone ECT in the last four decades, and from the United States, New Zealand, Australia, Canada and the UK.

A study that would truly reflect the honest experiences of ECT patients would involve interviewing thousands of patients across the world. Other research that is desperately needed is a before and after-ECT study of the brain. The American Psychiatric Association is on record as saying it opposes such a study.

A large-scale study of ECT recipients’ perceptions about their treatment would be a good use of NIMH funds, and something that should be considered by researchers in future studies.

The actual survey was conducted via the Internet and regular mail between the months of January and April, 1996, with a period of follow-up questions in May and June. Participants were given not only an electronic mail address, but a post office box if they had no access to computers or wanted more anonymity. Additionally, anyone could use one of the anonymous servers on the Internet if confidentiality were crucial. Those servers provide an anonymous identification so that the reviewer could follow up with additional questions, yet not know the identity of the responder.

Analysis

41 replies were received. 23 from females and 18 from males. The average age at time of ECT treatment was 37. For females, the average age was 38.39, for males, 35.22.

75% of the respondents had their ECT treatment in this decade. The remainder had their treatments in the 60s (2%), 70s (12%) and 80s (9.7%).

Among all respondents, 70% felt it had no effect on their depression (or whatever symptoms were being treated). 12% said it had some, or temporary effect on their symptoms. Among females, 65.2% felt it had no positive effect, and among males, 77.7% felt it did no good.

Of all respondents, 17% reported that they felt their ECT treatments helped them. Among females, 21.7% felt it helped them and 11% of males felt it helped.

Memory loss is a major concern among those who have undergone ECT. 83 percent felt that their long-term memory had been affected . This ranged from loss of certain events in their lives, to the inability to remember family members, and in some cases, up to 20 years of memories were erased. Only 17% felt that their long-term memory had not been adversely affected.

“The worst thing that ever happened to me…”
“ECT destroyed my family…”
“Doctor claimed memory problems would vanish in two weeks…”

Of females, 82.6% said long-term memory was affected, and among males, 83.3% reported problems.

“I can’t remember my 20-year Marine Corps career…or daughter’s birth or childhood…”

Short-term memory appears to have been affected slightly less, or the effects were temporary. In all, 63.4% reported problems with short-term memory loss. 12% said they had no problems at all with short-term memory loss. And 22% said that short-term memory loss was either temporary or minor.

“I couldn’t remember people’s names, but it gradually came back…with some prompting…”

Half of all respondents reported that they were given no information about ECT and its effects, other than to be told it was effective. The other half were given information in the way of video tapes, pamphlets, books, and detailed discussions with their physician or nurse. Of those, however, several reported that they wish they’d been given more accurate information concerning memory loss and other adverse effects.

“I did have detailed discussions with my doctors before the treatment, but I just couldn’t realize how bad the memory loss was going to be. If I had, I’m not sure I would have taken the treatments…”

Informed consent is a crucial issue among ECT survivors, many of whom feel they were lied to. And being given accurate information prior to ECT may have a bearing on the aftermath. Among those who reported they had been given information prior to ECT, 30% said ECT helped them, and another 25% felt it had provided some or temporary relief. And among that same group, 45% said they would consider ECT again if other treatments failed. 35% said they would absolutely not have it again, with the remainder reporting that they might consider it, but were not sure.

“My doctor told me nothing except how great it was supposed to be…”
“I was told there would be no permanent damage and memory would return in six weeks. I am still waiting—it’s 11 years and six weeks…”
“Doctor stopped returning my phone calls when I said ‘memory’s not returning…’”
“I was certainly not exposed to any information about the possibility of the type of damage I have suffered…”

Among all respondents who answered the question (6 provided no answer to this question), 42.85% said they felt ECT had caused definite changes in cognitive abilities. This included being able to do mathematics, balance checkbooks, use their technical skills, write, and use their creativity. 40% said that ECT had caused no cognitive damage, with the rest either unsure or feeling the damage was minimal.

“Brain damage has been documented by testing (3 times)…”
“The neuropsychiatrist admitted that impairment was probable, although difficult or impossible to test for conclusively…”
“Turned me into a walking zombie, killing all emotions and feelings for several months…”
“It’s like a bomb being set off inside your head…literally a mind-blowing torture…”

The majority, 85%, had ECT to treat major depression. The remaining 15% had rapid cycling, mania, mixed states, and one person reported he was given ECT because of juvenile delinquency.

30% of the respondents were unsure of whether they had unilateral or bilateral treatments. Of the remaining , 63% reported they had bilateral, with 7% reporting unilateral ECT treatments. One person had both unilateral and bilateral during different series of treatments.

The smallest number of ECT treatments reported was three, after the patient refused to have another. The highest was greater than 100. (This number is not figured into the following average.) Of those who knew the number of treatments they had, the average number was 12.6.

The following question was asked in the form of a follow-up question: “If you felt ECT harmed your memory seriously or caused other adverse side effects, did you discuss this with your doctor following treatment?”

The answer to this question is the most important finding in the study, in the author’s opinion. Two respondents said they discussed this with their doctor afterwards, and were treated with kindness, sympathy and respect. Eight said they attempted to discuss the problem, but their feelings were dismissed by the doctor. The doctors said they mis-remembered, or the problems were from the underlying depression or medications, or they simply were mistaken. These eight people reported that they felt the doctor did not believe them, or did not care.

Of those who answered the follow-up question, 24, or 75%, said they never returned to the doctor who performed the ECT. Therefore, the doctor never knew the problems that ECT caused the patients…and thus, when doctors claim they have few to no patients who complain, they may be telling the truth.

This kind of finding should astonish doctors who perform ECT, and should cause them to follow up on patients who leave their care after the treatment, as well as reconsider their opinions on patient complaints.

While this study is not meant to be the last word on patient views of ECT, it should be carefully studied by those who perform the treatment. The alarming rate of those patients who feel damaged by ECT and never return should open the eyes of the medical community and help them understand some of the reasons they feel their patients do not suffer any negative side effects.

Conclusions:

Critical to the understanding of ECT and its outcome is to give a strong voice to those who have undergone this treatment. True informed consent is crucial in order to give patients the chance to make an educated decision about the treatment of their illnesses. Many patients continue to express their dismay in learning that they have suffered more severe side effects than doctors prepared them for.

It is hoped that this study will act as a catalyst to further research, one which will continue to listen to the patients of ECT.

References

Durr AL, Golden RN (1995) Cognitive effects of electroconvulsive therapy: a clinical review for nurses. Convulsive Therapy 11(3):192-201.

Reid WH (1993) Electroconvulsive therapy. Tex Med 89:58-62.

Frith CD, Stevens M, Johnstone EC, Deakin JF, Lawler P, Crow TJ (1987) A comparison of some retrograde and anterograde effects of electroconvulsive shock in patients with severe depression. Br J Psychol 78 ( Pt 1):53-63.

Williams KM, Iacono WG, Remick RA, Greenwood P (1990) Dichotic perception and memory following electroconvulsive treatment for depression. Br J Psychiatry 157:366-72.

Calev A, Gaudino EA, Squires NK, Zervas IM, Fink M (1995) ECT and non-memory cognition: a review. Br J Clin Psychol 34: 505-515.

Squire LR, Slater PC. (1983) Electroconvulsive therapy and complaints of memory dysfunction: a prospective three-year follow-up study. Br J Psychiatry 142:1-8.

Freeman CP, Weeks D, Kendell RE. (1980) ECT: II: patients who complain.
Br J Psychiatry 137:17-25.

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About the author

Juli Lawrence, MA, BS, BA, is a freelance journalist, specializing in health-related topics. Her educational background includes degrees in journalism and Russian language/literature, and a Master’s in cultural anthropology. She received bilateral ECT in 1994.

She worked for several years in social services, primarily in public relations, but also did prevention work among adolescents. She is the co-author of a manual for prevention workers on combating substance abuse during adolescent pregnancy. Prior to her work in social services, she worked as reporter/editor for several newspapers and wires.

She recently presented a paper at the 45th National Conference on Mental Health Statistics in Washington, D.C and served on the Federal Task Force on ECT.

She may be reached at emailgraphic.jpg

Electro-convulsive Therapy, its Use and Effects: Salford Report

Electro-convulsive Therapy,
its Use and Effects.

Salford Community Health Council
22 Church Street
Eccles
Manchester M30 0DF.

0161-789 0474 (voice or minicom).
fax0161-788 9872
e-mailSalford_CHC@compuserve.com

April 1998.

“Salford Community Health Council – promoting
equal opportunities in the local Health Service.”

Foreword

Electro-convulsive therapy (E.C.T.) is one of the most controversial medical treatment being practised today. Despite this controversy, however, there has been almost no public debate in Salford about E.C.T. and its use. Even various innovative approaches to seeking users’, survivors’ and carers’ views on mental health services had never even elicited any comments or concerns about it.

Unusually for a community health council (C.H.C.), Salford C.H.C. was prompted by this silence to investigate E.C.T. and its use in the Mental Health Services of Salford. As this report testifies, the project was a long and detailed one. The C.H.C. hopes that it has done justice to the subject and more especially to those people who have had E.C.T. or who will be given it in the future.

Salford C.H.C. would like to thank the following people for their help, advice and support during the Project:

* All the users, survivors and carers who gave their time and views on what
* for some of them is a distressing subject.
* Staff and managers of the Mental Health Services of Salford N.H.S. Trust:
* Peter Clarke; Steve Colgan; Avril Harding; Les Hardy; Keith Hyde; Gillian Moss; Malcolm Rae.
* Everyone else in Salford who helped with to the Project: Margaret Argyle;
* Liz Farrell and Jacquie Muskett of the Library at Salford and Trafford Health Authority; Pat Garrett, Muriel Mann and the members of Survivors in Salford; Sam Portnoy.
* Everyone else who contributed to the Project, including: the Association of
* Community Health Councils for England and Wales; Pat Butterfield and E.C.T. Anonymous; Patricia Dawson and the Scottish Association of Health Councils; Alex Doherty; John Foot; Sue Kemsley; Ian Parker and the members of the North West Right to Refuse Electroshock Campaign; Jacky Ward-Panter of North West Mind.

Salford C.H.C. hopes that the report, and the responses to its contents and recommendations, will help to create better and more effective mental health services for the people of Salford and those further afield.

Chris Dabbs,
Chief Officer.27 April, 1998.

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1. Introduction.

As part of its Work Plan for 1996/97, Salford Community Health Council (C.H.C.) agreed to undertake a project into the use of electro-convulsive therapy (E.C.T.) in Salford. A project team was established, whose members were:

Mrs. Milly Alvarez
Mrs. Margaret Argyle
Ms. Hazel Blears
Dr. Mark Gabbay
Mr. Sam Portnoy
Rev. Ken Stokes

1.1 Aims:

The aims of the Project were:

1. To assess the use of E.C.T. in Salford.

2. To establish survivors’ views about the use of E.C.T.

1.2 Objectives:

The objectives of the Project were:

1. To collate information about E.C.T., its use, effectiveness and side effects.

2. To identify criteria and guidelines against which to assess the use of E.C.T.

3. To identify and assess the use of E.C.T. in Salford.

4. To establish the views of survivors in Salford who have had E.C.T.

1.3 Terminology:

The issue of terminology is a sensitive one. Salford C.H.C. recognises that different people use different terms and strongly object to others. In this report, the term “patient” is used to describe those people having or about to have E.C.T., and the term “survivors” for those people who have had E.C.T.

2. Electro-convulsive Therapy and Its Use.

2.1 Electro-Convulsive Therapy.

E.C.T. involves passing an electric current through a person’s brain while they are under a general anaesthetic and have been given a muscle relaxant. This produces a convulsion (muscular contractions) modified by the anaesthetic.

There is evidence that seizures were used since the Nineteenth Century to treat schizophrenia (starting in 1834 in Hungary). These seizures were induced via various means such as with insulin and other so-called pharmacological means.

Electro-convulsive therapy (E.C.T.) was first used as a treatment for mental illness in 1938 by Cerletti and Bini (50), and then developed as a mainstream treatment. E.C.T. was used before the development of modern anaesthetics and muscle relaxants. It also predated drug treatments for depression. As such, it has had a significant historical role in influencing the perceptions of people towards mental illness and the potential of different treatments.

In the 1950s and 1960s antipsychotic, antidepressant, and anti-manic drugs were discovered (169). Although E.C.T. was partially replaced by drug treatments with reduced side effects, it continued to be used on a large number of people, the level of which tended to stabilise in the early 1980s.

Internationally, E.C.T. is banned in Italy, while its use is limited in Canada and the Netherlands. E.C.T. is used much less in other European countries than in Great Britain. For example, in West Germany in 1986, E.C.T. was used in 26% of state psychiatric hospitals, 40% of psychiatric departments of general hospitals and in 78% of university hospitals. A total of 500 people had E.C.T. in 1986, (compared with some 22 000 in England) (93). The use of E.C.T. is rare and discouraged by the authorities in Austria, China and Japan.

E.C.T. is perhaps the most controversial treatment currently used by the medical profession. While some survivors report it as helpful or life-saving to them, others find it much less helpful, and many view it as a damaging and threatening tool of psychiatric oppression. Especially controversial are:

* what conditions it is used to treat

* who is given E.C.T.

* its administration

* training of clinical staff

* variations in use and practice

* precisely how it works

* its effectiveness

* its risks and side-effects

* consent to treatment

2.2 What conditions is E.C.T. used to treat?

E.C.T. is principally used to treat depressive disorders, but is also used for mania, schizophrenia and various neuropsychiatric conditions. It has, however, been pointed out that many patients given E.C.T. have more than one diagnosis (125). One national survey of survivors found that E.C.T. had also been used for post-natal depression, anxiety, hypomania, post-traumatic stress disorder and puerperal psychosis (163).

2.2.1 E.C.T. and depressive disorders.

Although there are considerable variations between psychiatrists, E.C.T. is usually used as a treatment for depression when:

* other treatments (such as antidepressants) have not worked; or

* a patient is considered unable to tolerate or reliably take antidepressant medication; or

* E.C.T. is believed to be the safer option (for example, due to the
* side effects of antidepressants); and/or

* a rapid result is required when a person is very severely ill (for example, if they are acutely and actively suicidal, extremely distressed and/or refusing to eat and drink).

It is, however, notable, that many people who get E.C.T. remain on some form of medication as well.

In one survey of old-age psychiatrists, depressive psychosis was identified as the condition for which E.C.T. was felt most often to be useful (10).

2.2.2 E.C.T. and mania.

E.C.T. is also used to treat a number of people with mania. It should not, however, be used as a first-line treatment for mania unless the illness is genuinely life-threatening (79), as drugs such as haloperidol, phenothiazine and lithium are the mainstay of treatment for manic illness.

2.2.3 E.C.T. and schizophrenia.

It is argued that E.C.T. can be effective in schizophrenia, but mainly for those people with the positive symptoms of type 1 (acute) schizophrenia, and not for those with type 2 (chronic) schizophrenia unless there is co-existing depression (76). It is, however, important to note the arguments attacking the whole concept of schizophrenia as a concept developed by psychiatrists (156).

2.2.4 E.C.T. and neuropsychiatric conditions.

E.C.T. is still regarded as being useful as a specific treatment for some neuropsychiatric conditions, including catatonic schizophrenia (although this is now rarely diagnosed). E.C.T. has also been used to treat schizophrenia where neuroleptics are contraindicated due to neuroleptic malignant syndrome, and to treat neuroleptic malignant syndrome itself. (61)

E.C.T. is not in general use for Parkinson’s Disease. E.C.T. is not normally used to control epilepsy and related disorders, as drug treatments are now considered more appropriate. Likewise, it should not be used to treat violent or offending behaviour; diabetes or obsessive-compulsive disorders (61).

2.3 Who is given E.C.T.?

About 22 000 people are given E.C.T. in England each year (93).

2.3.1 E.C.T. and gender.

By far the majority of people who are given E.C.T. are women, especially older women. One study in Sheffield found that twice as many women as men were given E.C.T. (100), reflecting consistent findings elsewhere.

One national survey of survivors found that women who had E.C.T. were much more likely to be diagnosed with depression (62.2%) than men (47.7%). By contrast, men (34.6%) were more than twice as likely to be diagnosed with schizophrenia (163). This raises a question about the causes of these figures, including whether they are a result of social circumstances, stereotyping and/or other factors.

2.3.2 E.C.T. and age.

One study in 1980 (125) considered 2 594 courses of E.C.T. in detail. Patients’ ages could be broken down thus:

Age Number*
16-19
35
20-29
247
30-39
335
40-49
365
50-59
571
60-69
522
70-79
357
80+
75
Total
2,507

* Note: the age of a few patients was not recorded (125).

This work suggests an average age for E.C.T. patients somewhere in their fifties. This is supported by a study which found patients were aged from 19 to 83 years, with a mean of 53.6 years (132). The apparent variation in average ages may be due to the comparative rates of use of E.C.T. by adult and old-age psychiatrists.

2.3.3 E.C.T. and people under 18 years old.

E.C.T. is very rarely the first line of treatment for children and young people under 18 years, although the Royal College of Psychiatrists “can envisage situations where this might be so” (Freeman (ed.), 1995: 18). Organisations such as Mind continue to campaign for a ban on E.C.T. for young people under 18, as is the case for young people under 16 years in Colorado in the United States. There is very little good research on the effects of E.C.T. when used on children and young people.

There is no evidence that E.C.T. is used on children aged 12 years or younger and there are no clear indications for this (61). In the ten years to 1992, at least 60 young people (aged 12-17 years) were given E.C.T. (60), with over 60% of these being aged 16-18, although the methodology for this has been questioned, not least that it is based on a survey of child and adolescent psychiatrists, when most young people who are given E.C.T. are those under adult psychiatrists.

2.3.4 E.C.T. and older people.

A significant proportion of people who get E.C.T. are over 65 years old. One study in Sheffield found that the average age of E.C.T. patients was 68 years (ranging from 20 to 92) (100). The Royal College of Psychiatrists states that “treatment is not contraindicated by age alone” (Freeman (ed.), 1995: 17). Older women are the group most likely to get E.C.T.

2.3.6 E.C.T. and ethnicity.

There are no national statistics on the ethnicity of people who are given E.C.T. This information is neither required nor collected by the Department of Health.

2.3.6 E.C.T. and pregnancy.

One review of 300 case reports concludes that E.C.T. is “a relatively safe and effective treatment during pregnancy if steps are taken to decrease potential risks”, although it found a small number of significant complications (including miscarriages, stillbirth, and congenital abnormalities) and milder problems (including benign fetal arrhythmias, mild vaginal bleeding, abdominal pain, and self-limited uterine contractions) which may or may not have been a result of the E.C.T. (109).

Later work suggests that complications reported for pregnant patients who had E.C.T. during pregnancy have not been conclusively associated with the treatment 95. Likewise, however, very little is known of the risks of antidepressant medications for a foetus.

The E.C.T. Handbook states that E.C.T. can be given to pregnant women (61). It states that:
E.C.T. may be prescribed with confidence for pregnant patients in the second and third trimesters of pregnancy:
* (a)where patients display symptom patterns strongly indicative of a good response to E.C.T.;
* (b)when rapid control of symptoms is required;
* (c) where there is an increased risk of toxicity to both mother and foetus when effective dosages of psychotropic drugs are used as an alternative.
Little is known about the effects of E.C.T. in the first trimester of pregnancy.
There is no evidence of a need for routine sophisticated monitoring of maternal and foetal status.
It is advisable to discuss the case with the patient’s obstetrician when a psychiatric decision is taken to administer E.C.T. to a pregnant patient.
High-risk pregnancies are not an absolute contraindication to E.C.T., provided that the patient is jointly managed by a psychiatrist and an obstetrician, and that facilities exist for careful monitoring of maternal and foetal status. (Freeman (ed.), 1995: 22).

2.4 Administration of E.C.T.

2.4.1 Description.

In its patient fact sheet on E.C.T., the Royal College of Psychiatrists describes what should happen when a patient has E.C.T., for which they should fast for at least six hours beforehand:

“For the treatment you should wear loose clothes, or night clothes. You will be asked to remove any jewellery, hair slides or false teeth if you have them.

The treatment takes place in a separate room and only takes a few minutes. Other patients will not be able to see you having it. The anaesthetist will ask you to hold out your hand so you can be given an anaesthetic injection. It will make you go to sleep and cause your muscles to relax completely. You will be given some oxygen to breathe as you go off to sleep. Once you are fast asleep, a small electric current is passed across your head and this causes a mild fit in the brain. There is little movement of your body because of the relaxant injection that the anaesthetist gives. When you wake up, you will be back in the waiting area. Once you are wide awake, you will be offered a cup of tea.” (Royal College of Psychiatrists, 1995b: 2).
This description does not mention the following:

* the injections for general anaesthetic and the muscle relaxant are given separately

* the anaesthetist gives the person oxygen with a face mask and a pressure bag;

* the use of padded electrodes – bilateral E.C.T. (on the temples) or unilateral E.C.T. (on the same side of the head);

* a gag will be placed in the person’s mouth to prevent them biting their tongue.

Some also question the use of the terms “small current” and “mild fit” in this description, arguing that the seizures and other effects are much more substantial than this.

2.4.2 Good practice and guidelines.

E.C.T. should be given according to the good practice guidelines set out by the Royal College of Psychiatrists. The wide variation in its rates of use does raise the question of how consistently and rigorously standard criteria are used. To accompany The E.C.T. Handbook (61), the Royal College of Psychiatrists produced within it Checklists for Good Practice in E.C.T. (139). This document gives guidance to psychiatrists on the following (with more detail on each included in The E.C.T. Handbook):

Resources and equipment.

Preparation for E.C.T.

Prescription of E.C.T.

Administration of the anaesthetic

E.C.T. stimulus parameters and seizures

Monitoring seizure activity

Restimulation policy

Recovery

Continuity of care

Monitoring clinical response.

The Mental Health Act Commission stated in 1997 that it was “considering ways in which to ensure that [the E.C.T.] Handbook’s recommendations are adopted.” (Mental Health Act Commission, 1997: 105). The Commissioners have a responsibility to ensure that treatment given to patients detained under the Mental Health Act meets their standards. This involves reviewing issues about informed consent, the provision of second opinions, and the facilities and staff where the treatment is provided.

Some psychiatrists argue that E.C.T. should be reserved as a treatment of last resort. Others, however, argue that it is not necessary for all other methods to be exhausted before its use, especially for conditions such as pregnancy, acute and severe suicidality, or an inability to tolerate antidepressant medications (127).

2.4.3 Dosage.

The dosage of electric current should be enough to induce a fit, with the amount of electrical energy used being an important variable (26). If the dose is too low, a fit does not occur. The amount needed to do this is about twice as high for men than women, and increases with age. The Royal College of Psychiatrists states that “the seizure threshold may be relatively high in some elderly patients and these patients may require a relatively high stimulus charge” (Freeman (ed.), 1995: 17). If the dose is too low, there will be little or no effect. The higher the dose above the threshold, the greater the risk of negative side-effects. It should be noted that muscle relaxants sedate the brain, thus increasing the seizure threshold. The Royal College produces detailed guidance on “stimulus dosing” in its E.C.T. Handbook (61).

2.4.4 Frequency and number of treatments.

E.C.T. is usually given to a person two or three times a week. It should not be given on a daily basis (61). One study concluded that E.C.T. twice a week is as effective as E.C.T. three times per week and has less severe cognitive effects (96), although the higher number is still used in many places. The number of treatments varies between patients, usually ranging between two and 12 treatments. Most people respond to a course of between four and eight treatments. Older people and men may need more than this. The Mental Health Act Code of Practice states that the proposed maximum number of applications of E.C.T. should be recorded on form 38 which is completed if the patient consents (36).

2.4.5 Anaesthesia.

Despite detailed guidance on anaesthesia for E.C.T. from the Royal College of Psychiatrists (61), there is strong evidence to indicate that the anaesthetic standards of care and facilities for patients getting E.C.T. are substantially inferior to those of other patients and commonly fall short of accepted national guidelines (such as those set by the Association of Anaesthetists of Great Britain and Ireland, the Royal College of Anaesthetists and the Working Group on Mental Illness of the Clinical Resource and Audit Group of the Department of Health at The Scottish Office 26) (94). As the Registrar of the Royal College of Psychiatrists wrote: “Surgical procedures which are carried out under general anaesthetic are undertaken to exacting quality standards, and the College believes that the same should apply to E.C.T.” (Thompson, 1997).

Questions have been raised about the level of anaesthesia given to E.C.T. patients. It has been suggested that patients who receive E.C.T. in the United Kingdom commonly receive 50-60% more anaesthesia than patients in the United States (39).

In addition, calls have been made to investigate the approach to patients who smoke. Patients undergoing anaesthesia are routinely discouraged from smoking. Many anaesthetists will not deal with patients who will not or cannot resist their habit. Yet there is anecdotal evidence that E.C.T. patients will be allowed to smoke before treatment in order to calm them down.

2.4.6 E.C.T. and nursing.

The role of nurses in the administration of E.C.T. has, until recently, been given relatively little consideration. Following an appendix in the Royal College of Psychiatrists’ E.C.T. Handbook (61), the Royal College of Nursing’s E.C.T. – Guidance for Nurses attempts to redress this imbalance, taking the view that “High quality provision of nursing care does a great deal towards improving the experience of the treatment for the patient” (Royal College of Nursing, 1997: 4). It recommends:

* the primary concern must always be the well-being of the patient and not an individual nurse’s feelings regarding the treatment

* all aspects of nursing care surrounding the treatment should be care planned

* nurses who do not feel competent or adequately skilled to escort patients throughout the treatment should not take on this role until training has been provided

* a named E.C.T. manager with responsibility for the overall management of the physical environment, the E.C.T. facility and the maintenance of equipment, working with the consultant with lead responsibility for the treatment service

* nurses who escort patients should be registered nurses familiar with the patient, should remain with them at all times and be responsible for the monitoring of vital signs, post-treatment confusion and disorientation during the recovery phase (documented on a post-E.C.T. check list)

* only qualified nurses familiar with the E.C.T. machine and procedure, and under the verbal directions of the treating psychiatrist, should carry out the process of pressing the treatment button on the machine (where this exists) to trigger the stimulus and test function. (137).

There is also additional guidance available on the role of the “ward nurse” and the “E.C.T. nurse” (26).

2.4.7 Post-treatment care and observation.

There are concerns about the post-treatment care and observation of people who have had E.C.T. E.C.T. can affect the short-term memory of many patients who may, therefore, forget warnings about not being alone, going home alone or drinking alcohol.

Although the length of stay of outpatients receiving E.C.T. may vary according to the local anaesthetic policy, the most recent guidance concurs on its recommendations in many respects:

* each outpatient should have a friend or relative with whom to go home, both in case there are unforeseen effects from the anaesthetic and also because of the risk of suicide (133).

* “outpatients . . . should not be allowed to return home until they have fully recovered from the ‘hangover’ effects of the general anaesthetic. Ideally, outpatients should be accompanied home by a friend or relative and in no circumstances should they be allowed to drive themselves home in a motor vehicle.” (Freeman (ed.), 1995: 119).

* “Furthermore, they should be advised to avoid alcohol . . . Where an outpatient arrives unaccompanied, it is the responsibility of the clinical nurse manager to ensure that the patient is not allowed to leave until fully recovered” (Freeman (ed.), 1995: 116).

* “outpatients should not drive themselves home, or return home unescorted, and certainly not before they are fully recovered from the effect of the anaesthetic. This may be up to four hours after treatment. For hospitals spread over a wide geographical area, those patients being treated from outside the immediate hospital should be treated as outpatients.” (Royal College of Nursing, 1997: 3).

* “It is recommended that outpatients have a relative or friend who can accompany them and who can stay with them following treatment for a period of at least 18 hours.” (Clinical Resource and Audit Group, 1997a: 23).

Particular care is required when providing E.C.T. to outpatients and the available guidance should be carefully followed (26).

This caution should also be applied to inpatients, many of whom are not detained under the Mental Health Act, but who still require supervision after they have had E.C.T. due to the possible effects of the treatment on their memory and of the general anaesthetic. The risks for inpatients might be seen in some ways as being at least as great as for outpatients, especially where they may be more ill and/or not detained under the Mental Health Act. Post-E.C.T. supportive observation is an area little considered to date.

2.4.8 E.C.T. and drugs.

Only a little research has been undertaken to identify the interactions between E.C.T. and different drugs, their safety and the outcomes they produce for patients (61) (86). The Royal College of Psychiatrists’ E.C.T. Handbook concludes that:

* The majority of patients receiving E.C.T. will be taking concomitant medication.

* Psychotropic and anaesthetic drugs have a significant effect on both seizure threshold and seizure duration during electro-convulsive therapy.

* Drugs which reduce the duration of seizure by increasing the seizure threshold may be associated with treatment failure.

* Alternatively, a larger number of E.C.T. treatments may have to be administered to achieve the desired therapeutic effect. This situation should be avoided as it increases the risk to the patient receiving E.C.T.

* Despite the obvious importance of this area, few clinical studies have been undertaken. Most of the research has been done in animals, and particularly rats.

* Although this work has highlighted some important areas for further research, such studies should be treated with caution.

* The effects of psychotropic and anaesthetic drugs on the efficacy and safety of E.C.T. are neglected areas of research. There is an urgent need to undertake clinical research; this has the best chace of being successful if a collaborative approach is adopted between psychiatrists and anaesthetists.” (Freeman (ed.), 1995: 55).

One study highlighted two cases in which older women, both with heart disease, taking tricyclic antidepressants and on longer than usual courses of E.C.T. died from heart attacks during their course of treatment. This raises “the question of whether in such ‘at risk’ patients E.C.T. and tricyclics should be given together.” (Freeman and Kendell, 1980: 16).

2.5 Training of Clinical Staff.

It is clearly recommended that there should be a named consultant responsible for the supervision of the E.C.T. service and for ensuring that it meets the standards required by the Royal College of Psychiatrists. This includes: developing local protocols and procedures; (continuous) audit; supervision of the training of junior staff; and liaison with anaesthetic colleagues. (26).

The traditional British system is to delegate responsibility for administering E.C.T. to junior doctors on rotation. “This means that as many as 10 different doctors may be on the E.C.T. roster at any one time, that there will be a high turnover of doctors as they move on rotation to other hospitals and that a high proportion of administering doctors will be on their first or second job.” (Duffett and Lelliott, 1997: 564). The situation in England and Wales contrasts with that in the United States, where the American Psychiatric Association requires that doctors are specifically accredited before they are allowed to give E.C.T.

There are concerns about the standards of training and practice in the administration of E.C.T. One survey of 115 doctors below consultant level showed that there is no consistent method of training in E.C.T. Some who used E.C.T. had not even been taught how to do so. Many had no guidelines and consultant supervision was rare. (75)

A survey of junior doctors in 53 E.C.T. clinics across East Anglia, North-East Thames and Wales (undertaken as part of the Royal College’s third audit of E.C.T. in 1996) highlighted that “the training in E.C.T. appeared to be of variable quality and one-half [of the respondents] had not been supervised by an experienced psychiatrist on the first occasion they administered E.C.T. Responses to exam-type questions revealed that 45% lacked knowledge about one or more basic issues related to effective administration of E.C.T.” (Duffett and Lelliott, 1997: 563). The majority of doctors on E.C.T. rosters would have been in their first year of specialist psychiatry training. The authors found that “the junior doctors in the only two clinics which were genuinely consultant-led had significantly greater knowledge (these clinics were also the only two judged exemplary on the overall rating). Unfortunately, these clinics were the exception.” (Duffett and Lelliott, 1997: 564).

The need for significant developments in the area of training (specific to administration) is illustrated by an example from the Queen Elizabeth II Hospital of the East Hertfordshire N.H.S. Trust for a visit by a second opinion appointed doctor in February 1996. In order to fulfil the requirements of the Mental Health Act, the doctor signed a Form 39 using a hospital secretary as a person “professionally concerned” with the patient’s treatment. A locum consultant subsequently questioned the validity of the form, which was withdrawn by the Mental Health Act Commission and a further S.O.A.D. visit arranged (105).

This area of major deficiency has only just begun to be addressed. For example, in 1997, the Mental Health Act Commission reported that it had held seminars for second opinion appointed doctors in Nottingham, Bristol and Chester on The E.C.T. Handbook of the Royal College of Psychiatrists (105).

In response to continued public criticism of E.C.T., the Royal College of Psychiatrists took a greater interest in training and established a Special Committee on E.C.T. to establish practice guidelines. The weight it gave to training may be reflected in the length of the chapter on training and supervision in its E.C.T. Handbook: half a page (61).

The Royal College’s Special Committee on E.C.T. also produced an “Official Video Teaching Pack”, with by a teaching manual, which addresses specific deficiencies previously reported in the administration of E.C.T. in Britain. It pays particular attention to training junior doctors and criticises the traditional method of junior doctors teaching each other. The video has, however, been criticised for being “potentially misleading” with some concepts “presented in a limited way that is more likely to confuse than clarify.” 80 To use the video, it is argued that a person would need considerable clinical experience and supplementary reading.

A role of the Royal College is “to inspect the facilities available for the administration of E.C.T. and ask searching questions about the training of the junior doctors administering the treatment in the course of its three to four yearly cycle of inspection of psychiatric training programmes around the country. If serious shortcomings are detected, as they are from time to time, the College informs both the Trust and the Postgraduate Dean concerned that it will withdraw educational approval from the Trust in question if the requisite changes are not introduced.” (Kendell, 1997).

The apparent frustration of the Royal College was illustrated in the explicit warning that “Failure to provide E.C.T. in accordance with [the College's] guidelines may result in withdrawal of approved training status of the provider unit concerned” (Thompson, 1997). The psychiatric profession has begun to recognise that E.C.T. may become legislated against because of its misuse.

The authors of 1996 survey for the Royal College of Psychiatrists commented that their audit “demonstrates that, despite the College’s recent initiatives to improve practice and 17 years of audit, E.C.T. is still often being delivered by inadequately trained personnel.” They conclude that, unless the traditional British system of delegating responsibility of E.C.T. administration is changed, “it will remain difficult to assure the quality of training and supervision in E.C.T. or to introduce a comprehensive national accreditation scheme, similar to that of the [American Psychiatric Association].” (Duffett and Lelliott, 1997: 564).

This move towards accreditation in England and Wales was strengthened by the ten-minute rule bill introduced into the House of Commons on 3 December, 1997, by John Gunnell, M.P. for Morley and Rothwell, which sought to ensure that E.C.T. is administered only by specially accredited doctors using up-to-date machines in clinics with statutory approval (Hansard, 3 December, 1997: 393; Electro-Convulsive Therapy (Restrictions on Use) Bill, 1997).

There are at present no training or competency standards for nurses practising in E.C.T. clinics, a situation that should be remedied at the earliest opportunity (26).

2.6 Variations in use and practice.

Over 100,000 E.C.T. treatments per year are given nationally, although it should be noted that, when the Department of Health collected statistics on the use of E.C.T. until 1991, some hospitals did not report all treatments (124). There are wide variations in its use between regions, hospitals and psychiatrists. Rates of use vary from 126 treatments per 100,000 people in Oxford to 420 per 100,000 in South Glamorgan (30). There are even greater differences between hospitals. There are also wide variations in the use of E.C.T. between individual psychiatrists. A study in one region showed that 15% of consultants were responsible for 40% of the treatments given (67).

A 1981 report sponsored by the Royal College of Psychiatrists showed wide variations in E.C.T. techniques, indications and practice. The report concluded that one third of the units examined failed to deliver adequate care (125). The Editor of The Lancet castigated the British psychiatric profession: “Every British psychiatrist should read this report and feel ashamed and worried about the state of British psychiatry. If E.C.T. is ever legislated against or falls into disuse it will not be because it is an ineffective or dangerous treatment; it will be because psychiatrists failed to supervise and monitor its use adequately. It is not E.C.T. which has brought psychiatry into disrepute. Psychiatry has done just that for E.C.T.” (Anon, 1981: 1208).

Apparently little attention was paid to the recommendations of the 1981 report (125), although there was encouragement for improvements in E.C.T. machines (123). An audit of E.C.T. in two N.H.S. regions of England found, however, some improvement in practice (124).

Despite some improvements in practice since the 1991 audit, a third audit undertaken for the Royal College of Psychiatrists of the administration of E.C.T. in 53 clinics in East Anglia, North-East Thames and Wales rated only 16 as good or exemplary, 26 as deficient in some areas of practice and 11 as poor. In summary, the audit produced these results:

* Supervision and training: although all services now have a named consultant psychiatrist responsible for the E.C.T. clinic and training, there is still room for improvement. It was apparent that members who had attended the College’s E.C.T. training courses were providing services to a higher standard.

* E.C.T. equipment: there has been a considerable improvement since the audit in 1991 and the majority of E.C.T. machines have now been replaced with more technically advanced equipment.

* Anaesthetic practice: as compared to 1991, there was an improvement in anaesthetic practice.

* E.C.T. clinic rooms: compared with 1991, some clinics had been relocated to better facilities and none were found to be substantially worse.” (141).

2.7 How Does E.C.T. Work?

There are a range of theories about how E.C.T. works. There is, however, little or no evidence or agreement in this area. The following examples illustrate that the process remains unknown or unclear:

* repeated seizures alter chemical messages in the brain (61);

* it possibly affects neurotransmitters in complicated and so far unexplained ways (25);

* it works “because the abnormality of brain function responsible for endogenous depression is unknown, it must be obvious from the outset that a direct answer to the question ‘how does E.C.T. work?’ is not possible at the present time” (Grahame-Smith, 1988);

* it works by changing brain chemistry, “but comparing this favourably with the current generation of pharmacologically specific drugs would be similar to the assumption that a broken television could be mended as readily with a sledgehammer as with a screwdriver: you might jog the right bit” (Green, 1992);

* “post-traumatic euphoria” similar to the effects that follow head and brain injuries, such as amnesia, denial, euphoria, apathy, mood swings, helplessness and submissiveness (17);

* through brain damage indicated by impaired mental function and changes in brain waves (56) (113).

These differing theories suggest that research has so far failed to identify the processes caused by E.C.T. and that any explanations are, at best, educated guesses.

2.8 Effectiveness of E.C.T.

2.8.1 Clinical Research.

Many clinical research projects undertaken by doctors conclude that E.C.T. is effective for the treatment of depressive illness. It is, however, important to note that studies tend to measure outcomes in terms of symptom reduction rather than quality of life and social functioning (114).

The Royal College of Psychiatrists states that “E.C.T. may be the treatment of choice for depressive illness” (Freeman (ed.), 1995: 17). It has been stated that E.C.T. can be used as an alternative to neuroleptic drugs (antipsychotic drugs) (61). Some state that patients who have had E.C.T. rather than medications experience greater clinical improvement and are also more likely to be alive at follow-up over the following one to ten years (122), although others suggest higher longer-term mortality and readmission after E.C.T. (116).

One study found that “both bilateral and unilateral E.C.T. are highly effective treatments for depression and are significantly superior to simulated E.C.T. There was also evidence that patients receiving bilateral E.C.T. recovered more rapidly than those receiving unilateral E.C.T. and required significantly fewer treatments.” (Gregory et al., 1985: 520). Another study concluded that, for inpatients thoroughly treated with medication trials, the response to E.C.T. may only be as high as 50%, whereas for those were not the response rate may be as high as 90% (130).

One early clinical trial compared the effectiveness of E.C.T., Imipramine, Phenelzine (a monoamine oxidase inhibitor) and a placebo on 250 patients aged 40-69 with depressive illness. This found that on a short-term (four weeks) and long-term (six months) basis, both E.C.T. and Imipramine “increased the frequency of recovery over and above the spontaneous rate shown by patients on the placebo”. E.C.T. was reported as specially effective in men and the drug in women. The report concluded that “Imipramine showed a slower action than E.C.T., but its use certainly reduced the total number of patients for whom E.C.T. was finally regarded as necessary.” (Clinical Psychiatry Committee, Medical Research Council, 1965: 886).

Several clinical trials have compared real and simulated E.C.T. One study compared one group of patients with depressive psychosis who received six brief pulse unilateral shocks under conventional anaesthesia and muscle relaxation with another group who underwent the same procedure without receiving shocks. The results of this led to the conclusion that the E.C.T. pre-treatment procedure has an important therapeutic effect, and cast doubt on the predominant view of the medical profession of the effectiveness of E.C.T. in general and of brief pulse unilateral E.C.T. in particular (91).

E.C.T. is not effective and should not be used to treat: violent or offending behaviour; diabetes or obsessive-compulsive disorders (61). It is also considered that “E.C.T. should not be used in the treatment of anxiety and post-traumatic stress disorder unless there is a co-existing depressive illness requiring E.C.T. in its own right” (Hyde, 1997: 2), although it might be said that someone looking for such coexistence is likely to find it.

2.8.2 Duration of Effect.

The natural history of most depressive illnesses is that they improve over time, but the length of time may be considerable. The consequences of a long-debilitating illness on the patient, their relatives and carers and their social situation are considerable. The question is whether they are any less for a person if they have E.C.T.

A wide variety of research appears to support the view that the therapeutic effects of E.C.T. are rapid and only short-term. Comparative trials found that those people getting real E.C.T. showed a swifter improvement in their symptoms than those who got simulated E.C.T. One study concluded that “the therapeutic effects of electrically induced convulsions in depression were of lesser magnitude and were more transient than has sometimes been claimed.” (Johnstone et al., 1980: 1317). Researchers have concluded that:

comparative trials between real and simulated E.C.T. showed significant difference between the two groups after two weeks, less after four weeks, and none at three or six months. (13) (71) (84);

“E.C.T. does not influence long-term survival. These findings combined with a close examination of the literature do not support the commonly held belief that E.C.T. exerts long-range protective effects against suicide.” (Milstein et al, 1986);

two trials found that patients with schizophrenia who had E.C.T. improved significantly better than those who did not both after six treatments and at the end of treatment 157 and in the first eight weeks 1, but there was little or no difference from 12-16 weeks or at six months 1;

patients with manic states who had E.C.T. “improved more during the first eight weeks than did patients who were treated with lithium carbonate [but] clinical ratings after eight weeks showed no significant differences.” (Small et al., 1988: 727);

later research on the long-term prognosis of depressed patients found that “index E.C.T. treatment predicted high longer-term mortality and readmission risks” (O’Leary and Lee, 1996: 423).

Many psychiatrists view E.C.T. as “a short-term solution for long-term problems” with no proven value (31). Even the Royal College of Psychiatrists recognises that E.C.T. may relieve only the symptoms of depression, while (dubiously) claiming that depression may produce domestic or work problems (rather than be caused by them). It argues that the survivor “will be able to deal with these other problems more effectively” if symptoms are relieved. (Royal College of Psychiatrists, 1995b: 3). There is, however, no evidence for this, as no research has ever been undertaken on it.

The conclusion that E.C.T. has only a short-term beneficial effect is supported by the 1995 national survey of survivors. Many said that it had given temporary relief from distress, but that this returned fairly soon afterwards. They felt that E.C.T. offered no “cure” (163).

There is a high relapse rate in the first four months after E.C.T. A follow-up of older survivors after E.C.T. found that a quarter were readmitted to hospital within six months and about 70% relapsed during the course of the 14-month study period (101). “Continuation” or “maintenance” E.C.T. is often recommended in such cases. This means that E.C.T. is given over many months, mainly to obtain short-term, rapid improvement rather than long-term relapse free survival. This might be seen as being based on the assumption that someone who has depression will have recurring episodes. It is, however, an area that is under-researched, with no reliable randomised control trials having been undertaken, although it is argued that it is safe and effective, especially for patients who relapse very quickly after a course of E.C.T. and where other treatments are ineffective (26). Nevertheless, the Royal College of Psychiatrists states that “continuation” E.C.T. should be considered when:

(1)the index episode of illness responded well to E.C.T.;
(2)there is early relapse despite adequate continuation drug treatment, or an inability to tolerate continuation drug treatment;
(3)the patient’s attitude and circumstances are conducive to safe administration.” (Freeman (ed.), 1995: 71).

2.8.3 E.C.T. and Suicide.

E.C.T. is often justified because of the more rapid change that it can create. It is argued by some that it avoids the risk of suicide or starvation (with a danger of kidney failure) that exists if severe depression runs its course.

E.C.T. can sometimes prevent death when a person is severely depressed and in a critical state through no longer eating or drinking. There is, however, little or no evidence that E.C.T. prevents suicide. In its Biennial Report for 1991-93, the Mental Health Act Commission reports that “the most frequent single indication for [E.C.T.] is that the patient is refusing to eat or drink as a result of their depressive illness. The reports of the appointed doctor frequently indicate that in their view the treatment in these circumstances is ‘life-saving’” (Mental Health Act Commission, 1993: 39). The Commission notes, however, that it has no means to systematically collect data on the outcome of treatment.

One paper often cited as supporting the view that E.C.T. does prevent suicide actually concludes that: “In the present study, treatment was not shown to affect the suicide rate” (7). Later, these same authors demonstrated that patients who were treated with E.C.T. made significantly fewer suicide attempts over a 6-month follow-up period than did patients who did not receive E.C.T. (7.) Likewise, a later study found that “Patients who committed suicide were more apt to have received E.C.T. than those who died from other causes, but this difference was not significant . . . E.C.T. does not influence long-term survival. These findings combined with a close examination of the literature do not support the commonly held belief that E.C.T. exerts long-range protective effects against suicide.” (Milstein et al, 1986).

2.8.4 Survivors’ Views.

There has been relatively little work done on establishing survivors’ views of E.C.T. It seems clear, however, that there is a polarisation of views among people who have had E.C.T. about how helpful it has been for them.

One study to seek the views of survivors involved a series of interviews with 166 people who had E.C.T. in the 1970s. It should, however, be noted that this was done by psychiatrists in a psychiatric hospital. The authors got the impression that those with strong views expressed them, but that it was less certain whether others were more distressed by E.C.T. than they were prepared to say. They concluded that most survivors “did not find the treatment unduly upsetting or frightening, nor was it a painful or unpleasant experience. Most felt it helped them and hardly any felt it had made them worse.” (Freeman and Kendell, 1980: 16). Many complained, however, about permanent memory loss, especially around the time of treatment.

A national survey of survivors in 1995 found that 13.6% described their experience as “very helpful”, 16.5% “helpful”, 13.6% said it had made “no difference”, 16.5% “not helpful” and 35.1% “damaging”. 60.9% of women and 46.4% of men described E.C.T. as”damaging or “not helpful” (163). This may be linked to the fact that women were less likely to receive an explanation of the treatment and more likely to be treated compulsorily.

The survey also concluded that survivors who had had E.C.T. voluntarily found it less damaging and more helpful than those receiving it compulsorily. 62% of those threatened with E.C.T. found it “damaging”, while this was true for 27.3% of those for whom E.C.T. was not used as a threat. Only 3.6% of those threatened with E.C.T. said it was “very helpful” compared to 17.7% of those who had not been threatened.

Of the women who did not consent, 50% described their treatment as “damaging” and only 8.6% as ‘very helpful’. By contrast, of those women who consented, 33.7% found it “damaging” and 16.5% ‘very helpful’. There was an even greater contrast amongst men. While 20% of the total who had had E.C.T. described it as “very helpful”, this figure was only 2.3% for those treated compulsorily. 21.2% of the men who had E.C.T. voluntarily described it as “damaging”, but this figure rose to 51.2% for those treated against their will. (163)

Likewise, whether an explanation is given before E.C.T. appears to affect survivors’ perception of the treatment’s effectiveness. 30.4% of those who got an explanation described E.C.T. as “very helpful” compared to only 8.5% of those who did not. Those getting an explanation were also less likely to describe E.C.T. as “damaging”: 11.6% compared to 44.8% who did not get an explanation. (163)

Diagnosis also appears to affect survivors’ views on E.C.T. In the survey, half of those diagnosed as having manic depression, 35.2% diagnosed with schizophrenia and 24.6% diagnosed with depression described their experience of E.C.T. as “damaging”. (163)

One major study found that 43% of survivors said E.C.T. had been helpful, and 37% unhelpful (134). This contrasts with the view of the Royal College of Psychiatrists that “over 8 out of 10 of depressed patients who receive E.C.T. respond well” (Royal College of Psychiatrists, 1995b: 3).

2.8.5 Who does E.C.T. work for?

There are no symptoms or clinical features proven as criteria to decide who will benefit from E.C.T. The E.C.T. Handbook states, however, that:

* The best predictor of a good response to E.C.T. is the number of the typical features of depressive illness

* E.C.T. may be particularly effective in depressive illness with psychotic features.

* Depressed patients who have not responded to antidepressant drug treatment may recover if treated subsequently by E.C.T.

* Continuation antidepressant drug treatment is essential after successful E.C.T.” (Freeman (ed.), 1995: 4).

It is also stated that “two particular symptoms, retardation and depressive delusions, respond well to E.C.T. and there is good evidence that patients with depressive delusions are more likely to fail to respond to antidepressant drugs.” (Clinical Resource and Audit Group, 1997a: 3).

Various studies have been undertaken to look at predicting the outcome of E.C.T. for different patients. It is significant that the most recent work indicates that psychotic features and psychomotor disturbance (rather than the severity of depression) are best correlated with a good response for E.C.T. (76) (122).

A review of two randomised control trials found that “patients who were neither retarded nor deluded did not benefit significantly from real as opposed to simulated E.C.T.” (Buchan et al., 1992: 355). Likewise, another study found that using any of the categories of “retarded/non retarded”, “agitated/not agitated” or “psychotic/non-psychotic” did not predict a good response to E.C.T. (148).

A third clinical trial concluded that patients with manic states who underwent E.C.T. “improved more during the first eight weeks than did patients who were treated with lithium carbonate [but] clinical ratings after eight weeks showed no significant differences between the lithium carbonate- and E.C.T.-treated patients. Likewise, the two groups had comparable rates of relapse, recurrence, and rehospitalisation during the follow-up period.” (Small et al., 1988: 727). The Royal College of Psychiatrists’ E.C.T. Handbook states that:

* E.C.T. may in occasional circumstances be the treatment of choice for severely manic patients.

* E.C.T. may be a safe alternative to high-dose neuroleptics, with the advantage of a faster therapeutic response.

* E.C.T. should be considered in less disturbed manic patients with slow or inadequate response to medication.

* The clinical state of the patient may mean that E.C.T. has to be delivered on the ward rather than in an E.C.T. suite.” (Freeman (ed.), 1995: 6).

Similarly, in assessing the effect of E.C.T. on people with schizophrenia, two different trials found that patients receiving E.C.T. improved significantly better than those who did not for about eight weeks, but there was little or no difference after that (1) (157). “[T]he superiority of real E.C.T. was not confirmed at the end of six months” (Abraham and Kulhara, 1987: 152).

The Royal College of Psychiatrists’ E.C.T. Handbook states that:

* E.C.T. is not recommended for Type II schizophrenic patients; the exception is when marked depressive symptoms arise in the context of a Type II syndrome.

* The practical usefulness of E.C.T. in Type I schizophrenic patients is limited to patients:

* (a)who are unable to tolerate a dose of a neuroleptic equivalent to 500 mg. chlorpromazine daily;

* (b)who are responding poorly to a dose of neuroleptic equivalent to 500 mg. chlorpromazine daily;

* (c)where the maximum rate of symptomatic response is required;

* (d)specific subgroups [acute catatonic states; schizoaffective states; acute drug-induced schizophreniform disorders; acute paranoid syndromes; patients with neuroleptic malignant syndrome].

* E.C.T. may reduce antisocial behaviour which occurs as a response to underlying Type I psychotic symptoms when antipsychotic medication alone fails to alleviate psychotic symptoms.” (Freeman (ed.), 1995: 9).

One study concluded that E.C.T. is safe and effective for the treatment of affective and catatonic disorders in patients with multiple illnesses (Rohland et al., 1993). Another severely qualifies this by stating it is effective “if the specific medical risks are carefully evaluated in each case, and appropriate modifications of technique are used to reduce the risk of potential complications.” (Zwil and Pelchat, 1994).

The Royal College of Psychiatrists’ E.C.T. Handbook states that:

* E.C.T. is an effective form of treatment in catatonic states, and may be life-saving in cases of lethal catatonia.

* E.C.T. may have a potentially life-saving role in the treatment of cases where the differential diagnosis of [neuroleptic malignant syndrome] and [lethal catatonia] is unclear.” (Freeman (ed.), 1995: 11).

One study concluded that E.C.T. not only helps the depression often associated with Parkinson’s Disease but it also helps the movement disorder as well. This only looked, however, at seven patients all of whom manifested delirium as a consequence of the E.C.T., and one of whom experienced no improvement in either the depression or the Parkinson’s symptoms (55). The Royal College of Psychiatrists’ E.C.T. Handbook states that:

* E.C.T. has a short-term anti-Parkinsonian effect.

* The place of maintenance E.C.T. in Parkinson’s Disease has not been established.” (Freeman (ed.), 1995: 12).
E.C.T. is not normally used to control epilepsy and related disorders, as drug treatments are now considered more appropriate. The Royal College of Psychiatrists’ E.C.T. Handbook states that:

* E.C.T. is very effective at terminating the acute mental state disturbances associated with spontaneous seizures which appear to have a direct relationship to the underlying seizure disorder, e.g. fugue, twilight, and post-ictal confusional states. One or a small number of E.C.T. treatments may suffice.

* E.C.T. is effective in the treatment of other more chronic mental state disturbances which are encountered in epileptic patients, e.g., schizophreniform and affective psychoses. Spontaneous epilepsy is neither a contraindication nor a specific reason for using E.C.T. to treat a coexistent mental state disorder in an epileptic patient.

* E.C.T. is a powerful anticonvulsant treatment, but the anticonvulsant effect is dependent on ongoing E.C.T. applications. Given the efficacy of contemporary anti-epileptic drugs, E.C.T. is only likely to be considered as a viable anti-convulsant treatment option in desperate cases where conventional drug treatment has failed.” (Freeman (ed.), 1995: 15-16).

2.8.6 E.C.T. and Alternatives.

The national survey of survivors by the United Kingdom Advocacy Network (163) concluded that most psychiatrists effectively see the prescription of drugs as the only alternative to E.C.T. Of the respondents, 76.3% had been prescribed drugs, only 15.2% received counselling or psychotherapy, and 17.8% were offered no other treatment at all. These latter figures were even lower for people under 30. Many respondents felt that “talking treatments” should have been made available to them as their illnesses had an emotional, psychological or spiritual dimension. They felt that little or no consideration was given to why they were feeling so depressed. (163)

One study confirmed that many depressive illnesses may be improved, even without physical treatments, by using intensive nursing and medical care (84). The evidence cited above suggests that, in the medium- and long-terms, E.C.T. is no more (and maybe even less) effective than other treatments. It appears to address only short-term symptoms and not the underlying causes of a patient’s condition.

Complementary to this is the view of many who oppose E.C.T. who argue that it does not allow more natural ways of combatting depression, such as:

* grieving

* building up self-confidence

* developing coping skills

* finding more positive patterns of thought and behaviour

* discovering ways out of oppressive situations

* being listened to (30).

It is argued that this approach “does not address the issue of mental illness and depression as a biological process. It does not explore the complex inter-relationship between genetic, biological, psychological and sociological processes that must be considered when planning treatment with a particular person. The list tends to confuse depression with grief and responses to stress.” (Hyde, 1997: 5).

This raises the contrast – and conflict – between medical and non-medical models of depression, its causes and treatment. There is perhaps a good case for a more holistic model that accounts for all the facets of an individual.

Mind argues that the relative effectiveness of different treatments needs more research, especially when access to psychological services and “talking treatments”, which aim to understand and empower people, remains limited. This situation is particularly underlined by the fact that, although older people (especially women) are at a high risk of depression and receive more E.C.T. than younger people, few counselling and psychology services target them, even though there is a body of knowledge and expertise for it.

2.9 Risks and Side Effects of E.C.T.

2.9.1 Effects of E.C.T.

E.C.T. is recognised to cause a range of effects in patients. These include:

cardiovascular effects (such as bradycardia; hypotension; tachycardia; hypertension; dysrhythmias; myocardial oxygen consumption);

cerebral effects (such as cerebral oxygen consumption, cerebral blood flow and intracranial pressure);

increased intraocular pressure; and

increased intragastric pressure.

Parasympathetic stimulation occurs almost immediately.

2.9.2 Contraindications for E.C.T.

In considering giving E.C.T. to patients who are physically ill, the Royal College of Psychiatrists recommends in its E.C.T. Handbook that:

* all coexisting medical conditions should be assessed and, where possible, treated before E.C.T.;

* the balance between risks and benefits must always be weighed;

* as far as possible, patients and their families should be involved in discussions about the treatment, its risks and benefits;

* E.C.T. is not a treatment in itself for [stroke, dementing illnesses or cardiovascular disease].” (Freeman (ed.), 1995: 28).

The contraindications for E.C.T. are quite controversial in the literature. It is also notable that psychiatrists’ views about absolute or partial contraindications diverge significantly (10). Doctors should gauge each patient on an individual basis and decide on the relative merit of E.C.T. against the risks to them. For some psychiatrists, absolute contraindications are:

recent myocardial infarction;

recent cerebrovascular accident; and

intracranial mass or lesion.

The Royal College of Psychiatrists’ Committee on E.C.T. considered, however, that there are no absolute contraindications to E.C.T. (61), but that it is desirable to wait three months following a myocardial infarction or cerebrovascular accident unless the benefits of E.C.T. are likely to outweigh the risks. It is also considered that E.C.T. can be considered in the presence of intracranial mass or lesion under some circumstances and with precautions (79).

Relative contraindications (those for which particular caution must be taken before a decision is taken to use E.C.T.) are:

angina pectoris; congestive heart failure;

severe pulmonary disease; severe osteoporosis;

major bone fractures; glaucoma;

retinal detachment; thrombophlebitis;

pregnancy.

E.C.T. presents much higher risks for a person with heart disease due to both the use of anaesthetic and the application of an electric current to cause a seizure. Risks are, however, also posed to these patients by the use of antidepressants (172).

Through a survey of old-age psychiatrists, it was found, however, that not one of 15 conditions was considered never inappropriate for E.C.T. treatment (10).

2.9.3 Side Effects of E.C.T.

The immediate side effects of E.C.T. commonly include:

amnesia
drowsiness
confusion
disorientation
apathy
physical weakness
headaches
nausea
dizziness.

For older people, there is a particular risk of heart problems, falls and strokes (31). The Royal College of Psychiatrists specifically states that “special precautions may be needed to guard against memory impairment or confusion (for example, longer gaps between each treatment)” (Freeman (ed.), 1995: 17).

Other side effects reported by survivors include: weight loss; weight gain; lack of concentration; loss of confidence, dignity and self-esteem; fear of hospitals and psychiatry; anger and aggression; psychological trauma; loss of self and soul; anxiety; body spasms; brain damage; nightmares and speech difficulties (163). Damage to the teeth, tongue, eyes and cutaneous structures (including burns where the electrodes have been located) are not unheard of.

“It is hoped that the new generation of modern E.C.T. machines will be less likely to cause problems with memory and cognitive function as the dose of E.C.T. given can be more accurately tailored to the needs of the individual. Brief-pulse E.C.T. is less likely to cause cognitive impairment than the old-fashioned sinusoidal wave treatment.” (Hyde, 1997: 3). It will be important to monitor whether less patients complain of long-term memory impairment as newer E.C.T. machines are brought into use, although unclear who will undertake this task as it has rarely if ever been done in the past.

2.9.4 Memory Loss.

The Royal College of Psychiatrists states that “E.C.T. does not have any long-term effects on your memory or your intelligence.” (Royal College of Psychiatrists, 1995b: 4). Its E.C.T. Handbook says, in contrast, that “some patients may, however, be left with discreet memory gaps for specific autobiographical events, the explanation for which is unclear.” (Freeman (ed.), 1995).

Memory loss is the most commonly reported side effect of E.C.T. It lasts at least a few weeks. Some survivors have, however, reported memory loss many years after E.C.T. Research has shown that this is different from poor memory caused by depression itself (2). One study found 60-70% of survivors had memory complaints six to nine months after bilateral E.C.T. (153). Another found that 55% of survivors felt that they had not regained their normal memory function three years after E.C.T. The researchers’ conclusion was that there existed some actual permanent memory gap as a result of E.C.T., even for those denying such an effect (152). A further study found that, unlike a control group, every survivor who had had E.C.T. showed a number of instances of amnesia which persisted over time (82). Even official figures, where they are kept, find memory loss as the most often reported complication. For example, in California between 1989 and 1994, 19.7% of all patients reported memory loss lasting longer than three months. This constituted 93.6% of all reported complications.

Through interviews in a separate project, 30 per cent of survivors felt that their memory had been permanently affected (64), a report supported by further research of survivors who complained about enduring unwanted effects of E.C.T. which found that they did have areas of impaired cognitive function, not all of which could be explained by other variables such as the levels of depression and medication (65). The two explanations given for this were either that E.C.T. does cause some lasting impairment of memory in a proportion of survivors, or that the self-selected group interviewed had worse memories than average and mistakenly attributed this to their past treatment. A third possibility – that those survivors who achieved average scores on the memory tests may have had better than average memories before E.C.T. and that they too may have been damaged by the treatment – was not considered.

The risk of memory impairment also varies according to the technique use to give E.C.T. (2) (89). It appears that bilateral E.C.T. causes more severe memory loss than unilateral E.C.T., at least in the short term (167), although some argue that the latter causes more severe damage to the part of the brain next to which the electrodes are placed (85). The Royal College of Psychiatrists’ E.C.T. Handbook recommends that:

* unilateral E.C.T. should be used where: speed of response is less important; there has been a previous good response to unilateral E.C.T.; and minimising memory impairment is particularly important;

* bilateral E.C.T. should be used where: speed and completeness of response have priority; unilateral E.C.T. has failed; previous bilateral E.C.T. has produced a good response without undue short-term memory impairment; and determining cerebral dominance is difficult (61).

It has been found, however, that most clinics never use unilateral E.C.T., some occasionally, and only a small number on a frequent basis (124).

Likewise, sine wave E.C.T. appears to cause more damage than brief-pulse E.C.T. A Department of Health working group in the 1980s concluded that the use of sine wave equipment appeared to arise only from convenience and could not be recommended. Nevertheless, a decade later, six out of 35 clinics in East Anglia were still using sine wave machines, and also bilateral electrode placement (124).

At the present time, there are no indicators based on solid research that can predict even reasonably accurately who will experience longer-term memory loss after E.C.T.

2.9.5 Emotional and Psychological Effects of E.C.T.

The emotional and psychological impact of E.C.T. is often underestimated or ignored. It is perhaps easier for clinical staff to recall those patients who have asked or benefited from E.C.T. than those who experienced it as an assault or a nightmare.

For those survivors who do feel damaged by E.C.T., the effects can be devastating. While some survivors report the beneficial effects of E.C.T. for them, others have commented on E.C.T.: “like dying, every time”, “the nightmare of E.C.T.”, “the fear of having it will remain with me for the rest of my life.” (Cobb, 1994: 3). Some survivors find that the loss of power that E.C.T. represents, with its invasive nature, can underline their feelings of guilt and worthlessness. It can even reinforce their resolve for suicide.

The Royal College of Nursing’s E.C.T. – Guidance for Nurses (137) addresses the importance of “psychological preparation for treatment”. It recognises that “E.C.T. understandably induces anxiety in a great number of those receiving the treatment. In addition some may find the experience of short-term memory loss after treatment disturbing.” The Guidance identifies a range of measures that can be taken to reduce anxiety associated with E.C.T. and also the levels of memory impairment experienced after treatment:

“Management of Anxiety.

* Ensuring that the patient is fully informed and that concerns surrounding the treatment are addressed and questions answered.
* The use of anxiety management techniques.
* Ensuring as short a wait as possible in the treatment waiting room.
* The escorting nurse to be known to the patient, preferably the patient’s named nurse.
* Offering reassurance and support.
Management of Cognitive Side-Effects of E.C.T.

The factors affecting memory loss are well understood: these are:

* Time.
* The nature of the event.
* The mental set at the time of perception.
* The mental set at the time of assessment.

Information which is more likely to be retained is:

* That which the client consciously attempts to retain.
* That which is familiar.
* That which is emotionally important.
* That which is not experienced or relayed too close to the time of treatment.

Care plans for the psychological effects of the treatment could include methods such as:

* A system of prompts to aid recall, either managed jointly between the named nurse and the patients, or by the patient alone.
* Encouraging the patient to consciously retain information that is important to them.
* Keeping events on the day of treatment to as regular a routine as is possible.
* Making relatives or significant others aware of the psychological effects and if possible involving them in the management of these.
* Whenever possible not relaying important information too close to the time of treatment.

It is important that the named nurse feeds back to the medical team patient responses to the treatment. In this way, adjustments in the administration of the treatment, such as the use of unilateral E.C.T. can be considered where individual are experiencing marked side effects. ” (Royal College of Nursing, 1997: 2-3).

2.9.6 E.C.T. and Brain Damage.

Some researchers have argued that the process of E.C.T. causes structural damage to the brain (16) (56) (85). Other studies, using computerised axial tomography (C.A.T.) and magnetic resonance imaging (M.R.I.) scanning, post mortem data and animal electroshock studies (E.C.S.) conclude that E.C.T. does not cause changes to a person’s brain structure (37).

2.9.7 Anaesthesia.

E.C.T. must be given with a general anaesthetic. There are thus the slight but not negligible risks of illness and even death associated with anaesthesia. This should be put in the context of the repetition of E.C.T. for most people 2-3 times a week.

2.9.8 E.C.T. and Death.

E.C.T. is not part of the remit of the National Confidential Enquiry into Perioperative Deaths, leaving little or no reliable evidence about what the relationship is between E.C.T. and death. Most existing clinical reports only relate deaths to E.C.T. where they occur very soon afterwards. Deaths are under-reported or are not linked to the administration of E.C.T. (16)

According to the Royal College of Psychiatrists, death within 24 hours of E.C.T. occurs in about one in 50 000 treatments, and is usually related to cardiovascular or pulmonary problems (E.C.T. is associated with hypertension and tachycardia)(140). (It should be noted, however, that this figure is given no source – although it appears to originate in California, which contrast with more comprehensive figures from Texas – and refers to deaths only in the College’s E.C.T. Handbook (61). By contrast, others estimate the risk of death as 4.5 deaths per 100 000 treatments 112. Older people are at a higher risk than younger ones.

2.10 Consent to Treatment.

2.10.1 Rules and Guidance.

As the Royal College of Nursing’s E.C.T. Guidance for Nurses underlines, there is a “need for a culture of openness, trust and maximum availability of information in which patients can arrive at fully informed decisions.” (Royal College of Nursing, 1997: 4).

As with other invasive treatments, consent must be given for E.C.T. for all patients. This does not, however, necessarily mean the consent of the patient themselves: E.C.T. is give to a large number of people every year without their consent under sections 58 and 62 of the Mental Health Act 1983. The doctor should explain to the person what the treatment involves, why it is proposed for them, and advise on any significant risks and alternatives. The patient must understand the nature, purpose and consequences of treatment and thus be aware of what they are consenting to for consent to be valid. The explanation should be given in language the person can understand (especially important for deaf people and people from black and minority ethnic communities), and supported by sufficient written information. Most patients can withhold or withdraw their consent if they wish, even before the first treatment has been given.

Coercion should never be used to persuade patients to have E.C.T. Consent should never be obtained under the threat of ‘consent or be sectioned’. A refusal by a patient to have E.C.T. should not be used to jeopardise their right to alternative treatments. Initial consent should not be taken to mean agreement to a ‘course’ of E.C.T., as it can be withdrawn at any time, and so its continuation should be verified before each individual treatment (26).

The provision of written information does not alter the need for the implications of the treatment to be explained adequately to the patient before asking them to sign a consent form. Patients who need to want further information should be given it before being asked to give their consent. It is also important to discuss the treatment after it has been given in case memory loss has affected the patient’s recollection. This may be especially important for outpatients receiving E.C.T., for whom there are model information sheets in addition to that provided for all E.C.T. patients (26) (61).

Consent for E.C.T. for patients under 16 years and adults with a learning disability requires particular care. This is a particularly complex legal area which calls for specialist advice. Some brief (but insufficient) guidance is available (61).

There is, however, a distinction to be made between voluntary patients and those detained under the Mental Health Act. The following applies directly only to detained patients.

Some guidance on information is contained in chapter 14 of the Mental Health Act Code of Practice. For consent to treatment, the Code states in section 14.13:

“Consent to treatment. The patient must be informed, in terms which he is likely to understand, of the nature, purpose and likely effects of the treatment proposed. (See Chapters 15 and 16). Patients must be advised of their rights to withdraw consent to treatment at any time before its completion and of the need for them to give fresh consent to treatment thereafter. If relevant a detained patient should be told how his refusal or withdrawal of consent can be over-ridden by the second opinion process operated by the Mental Health Act Commission and, where treatment has begun, of the doctor’s power to continue it on an urgent basis if the discontinuance would cause serious suffering to the patient. (These explanations should be the responsibility of medical and nursing staff).” (Department of Health and Welsh Office, 1993: 51).

For consent and E.C.T., two specific sections of the Mental Health Act apply:

(a)Treatment requiring the patient’s consent or a second opinion (section 58) -

the administration of medicine beyond three months and treatment by E.C.T. at any time. These safeguards apply to all patients liable to be detained except those detained under sections 4, 5(2), 5(4), 35, 135, 136 and 37(4), and also those conditionally discharged under sections 42(2), 73 and 74. All these patients can only be treated under common law.

(b)Urgent treatment (section 62) – in certain circumstances, the provisions of

sections 57 and 58 do not apply where urgent treatment is required. Any such decision is the responsibility of the patient’s responsible medical
officer (R.M.O.).

Under section 58 of the Act, the Code of Practice states that:

“16.9 When E.C.T. is proposed, valid consent should always be sought by the patient’s R.M.O.:

(a)if the patient consents the R.M.O. or the Second Opinion Appointed
Doctor (S.O.A.D.) should complete form 38 and include on the form the proposed maximum number of applications of E.C.T. Such information should be included in the patient’s treatment plan;

(b)if the patient’s valid consent is not forthcoming, the R.M.O. (in the
event that he wishes to proceed with the treatment) must comply with the requirements of section 58, which should be initiated as soon as possible.

16.10 Whenever practicable, staff should give a patient treated by E.C.T. a

leaflet which helps him to understand and remember, both during and after the course of E.C.T., the advice given about its nature, purpose and likely effects. This may help to ensure that a valid consent is in force.” (Department of Health and Welsh Office, 1993: 62).

Where a S.O.A.D. is sought from the Mental Health Act Commission via the Mental Health Act administrators, they should visit the patient and judge whether, “having regard to the likelihood of its alleviating or preventing a deterioration of [the patient's] condition, the treatment should be given. This must be done after consultation with the R.M.O. and two others professionally concerned with the patient’s care – one a nurse and the other neither a doctor nor a nurse.

Viscount Colville of Culrose (the first Chairman of the Mental Health Act Commission) outlined the role of the S.O.A.D. In the House of Lords, he said “I should say [the appointed doctor does not provide] a second opinion in the recognised technical or medical sense because we do not wish the doctor who comes to advise to substitute his own opinion for that of the consultant who is directly responsible, but merely to say whether or not he thinks that in the condition the patient is in the line of medication proposed and the plan of treatment are as a whole in accordance with good practice.” Thus, unlike the common use of the term “second opinion”, which is about a doctor concluding what they would do in the particular circumstances of a case, the second opinion required of a S.O.A.D. is whether the R.M.O.’s treatment proposal falls within the mainstream of psychiatric practice. The term can therefore be very misleading, and can raise the question of how much of a safeguard the S.O.A.D. system is for patients.

Having seen the patient, consulted with staff, and reached a judgement, the S.O.A.D. should complete a Form 39 if they agree to the treatment proceeding. On this, they must state the maximum number of treatments a patient can receive and also to state a time period within which it should be given. The Mental Health Act Commission suggests that it is good practice to regard the certificate of authorisation from a S.O.A.D. as lapsed where there has been a break of more than three weeks in a course of E.C.T. treatment. In these circumstances, the Commission suggested that a further second opinion is sought if the patient is not able to give valid consent under the terms of Section 58 (103).

In England and Wales, between July 1995 and April 1997, just over one-third of all referrals for a second opinion under the Mental Health Act 1983 were for E.C.T., with a small proportion for treatment plans involving both medication and E.C.T. There were significant variations, according to the gender and ethnicity of patients, in the types and frequency of treatments for which referrals were made. Men and women were referred in roughly equal numbers, but men more often for medication and women more often for E.C.T. (105).

2.10.2 Information and Explanations.

Mind suggests to people or their relatives to ask the doctor the following questions if E.C.T. is recommended:

What is the reason for suggesting E.C.T.?
Are there any long-term effects?
What are the risks associated with E.C.T.? How could E.C.T. help me?
Has every alternative treatment, such as drug treatment or talking treatments such as cognitive therapy been tried?
What treatment will be offered in addition to and after E.C.T.?
Is bilateral or unilateral E.C.T. planned?
How great is the risk of physical deterioration or suicide?
How many treatments will I have? At what dosage? Is this the recommended dosage for someone of my age and sex? (112).

The Royal College of Psychiatrists specifically states that “people who are being asked to consent to E.C.T. should be informed of any likely adverse effects of treatment” (Freeman (ed.), 1995: 70). In one survey, however, only 14% of survivors who had had E.C.T. had been given any information about it, and only 9% could remember being told about any adverse effects (134). In a consultation with older women, Mind found that no woman was told of the risks of E.C.T., while some women were informed and others not about the purpose of treatment, what it involves and the right to refuse (31).

It is especially important to highlight that many patients who are given E.C.T. are very severely ill at that time of treatment. Having a depressive illness can influence a person’s perception of events and their ability to think, ask questions and concentrate. One study of survivors’ experiences and attitudes towards E.C.T. found that many who had been involved in a previous study and got detailed explanations of E.C.T. claimed that they had never been given one. It was concluded that “it might . . . be beneficial to patients to give them a second explanation of the treatment after they have completed the course and are symptomatically improved.” (Freeman and Kendell, 1980: 16).

It is unclear how many people are given sufficient information (including about risks, alternatives and rights) to make an informed choice. One study found that less than 25% of those over 65 knew that electrodes were used in E.C.T. or that an electric current was passed through the brain (100). Certainly, only a small minority have direct access to independent advocacy when they might need it. This is particularly so for older people, for whom there is only a very small number of independent advocacy services (such as that run by Brighton and Hove Mind). The value of independent advocacy is beginning to be recognised: “The patient should be asked if they wish to meet with an advocate and what role they wish an advocate to play.” (Clinical Resource and Audit Group, 1997a: 10).

Whether an explanation is given before E.C.T. appears to affect survivors’ perception of the treatment’s effectiveness. In the 1995 national survey of survivors, 30.4% of those who got an explanation described E.C.T. as “very helpful” compared to only 8.5% of those who did not. Those getting an explanation were also less likely to describe E.C.T. as “damaging”: 11.6% compared to 44.8% who did not get an explanation. (163)

2.10.3 Validity of Consent.

The validity of consent may be questionable in many cases. In one study, almost half of the survivors thought that they could not refuse E.C.T. Some 45% of survivors knew that it was possible to refuse but often said that it was futile to do so as they would eventually get it anyway (100). Many survivors report that their experience is an emphasis on gaining their compliance rather than their informed consent 31.

Many respondents to a national survey of survivors said that they were given no choice but to consent to E.C.T. and so in effect their treatment was not strictly voluntary. They said that this was due to:

* fear of being sectioned
* desperation to leave the psychiatric unit
* avoiding drugs
* ignorance of rights
* incapability of challenging staff
* threats of having children put into care
* threats of having E.C.T. compulsorily if not voluntarily (more than a quarter of respondents were threatened with E.C.T. as a means of making them comply. (163)

Issues raised by survivors and their organisations in Scotland around consent have been summarised as follows and elicited a series of recommendations:

“(i)patients who feel they were coerced into having E.C.T. against their wishes;

(ii)patients who feel that insufficient explanation was given to them about the treatment;

(iii)patients who feel that alternative treatments were not fully explained or explored;

(iv)patients who fear that their strong desire not to have E.C.T. would be eroded by their severe depression and they would be unable to refuse E.C.T. if they became depressed again;

(v)patients who fear that they might not be given E.C.T. quickly enough and might not be able to explain this to a doctor who was reluctant to give E.C.T.” (Clinical Resource and Audit Group, 1997a: 28).

The importance of the nurse’s role in consent is emphasised in the Royal College of Nursing’s E.C.T. – Guidance for Nurses (137). This states that:

“Before treatment the doctor should provide the patient with information about the treatment, unwanted side effects and any alternatives.

The importance of the nurse’s role in obtaining informed consent should not be underestimated. The patient’s named nurse should ideally be present when consent for treatment is obtained. It may also fall upon the nurse to provide further or repeated information in order to maintain informed consent, or alternatively to enable an informed refusal or withdrawal of consent. Clear explanations should be provided for the following:

-The right to withdraw consent at any time.
-Possible side effects of the treatment.
-The process of administering the treatment.
-Fasting prior to treatment.
-Pre- and post-treatment observations.”

2.10.4 E.C.T. Without Consent.

Across England and Wales, approximately 2 000 people per year are given E.C.T. without their consent. The number of requests for a second opinion appointed doctor (S.O.A.D.) are reported by the Mental Health Act Commission as:




















Period Number of Requests
1985-87
3,362
1988-89
4,454
1989-91
4,144
1991-3
4,001
1993-95
4,607

These figures do not include people given E.C.T. without consent “in an emergency” under section 62 of the Mental Health Act for detained patients or under the common law for informal patients.

In its patient fact sheet. the Royal College of Psychiatrists states that patients who get E.C.T. without their consent are people who are seriously ill – for example, people who are suicidal, starving themselves, or who believe that they are too wicked to be treated. With the agreement of an independent psychiatrist (after the latter’s consultation with the persons’ doctor, a nurse and another professional who is not a doctor or a nurse), E.C.T. can be given to patients under the Mental Health Act 1983 if they are considered incapable of giving informed consent (or are capable but refusing consent) and the treatment is seen as necessary by the doctors. There is no information compiled to show whether or not the use of E.C.T. without consent varies between psychiatrists.

The 1995 national survey of survivors concluded that those who had had E.C.T. voluntarily found it less damaging and more helpful than those receiving it compulsorily. 62% of those threatened with E.C.T. found it “damaging”, while this was true for 27.3% of those for whom E.C.T. was not used as a threat. Only 3.6% of those threatened with E.C.T. said it was “very helpful” compared to 17.7% of those who had not been threatened. (163)

Of the women who did not consent, 50% described their treatment as “damaging” and only 8.6% as ‘very helpful’. By contrast, of those women who consented, 33.7% found it “damaging” and 16.5% ‘very helpful’. There was an even greater contrast amongst men. While 20% of the total who had had E.C.T. described it as “very helpful”, this figure was only 2.3% for those treated compulsorily. 21.2% of the men who had E.C.T. voluntarily described it as “damaging”, but this figure rose to 51.2% for those treated against their will. (163)

This continuing concern about this issue was reflected in a ten-minute rule bill introduced into the House of Commons on 3 December, 1997, by John Gunnell, M.P. for Morley and Rothwell, which sought to ensure that E.C.T. is not administered without a patient’s consent unless the patient requires urgent treatment (Hansard, 3 December, 1997: 393).

2.10.5 Variations in consent.

In one national survey of survivors, 71.7% said that they had had no explanation of E.C.T. at all. 29.9% of men and 20.3% of women got an explanation. Of those who got an explanation, 86.3% said that they understood it. (163)

A review of official records showed that of all the people who get E.C.T. without their consent, just over half are women over 50 (about 1 000 women per year), and 36% are women over 65 53. This finding is supported by the 1995 survey of survivors by the United Kingdom Advocacy Network, in which 38.7% of women were given E.C.T. compulsorily compared to 32% of men, regardless of diagnosis (163).

Older people and women are the least aware of their rights. This may be even worse for people in these groups who have a sensory impairment or are from black and minority ethnic communities. In one study, only 27% of people over 65 years knew they could refuse, compared with 71% of those under 65 (100).

There is also a contrast for consent to treatment in terms of diagnoses. The survey of survivors by the United Kingdom Advocacy Network in 1995 found that those diagnosed with schizophrenia were more likely, at 47.3%, to be given E.C.T. compulsorily than those with depression (27%) or manic depression (32.6%) (163).

3. Electro-Convulsive Therapy in Salford.

3.1 Background.

Mental health services in Salford are run by the Mental Health Services of Salford N.H.S. Trust, which runs both local services for Salford people and specialist services for people in North West England and the United Kingdom.

At the time of the project, E.C.T. suites were in use at Meadowbrook / Glendale (the main adult acute unit and acute unit for older people in Salford) and at Prestwich Hospital (the site of several specialist regional and national services).

To establish a basic knowledge of the use of E.C.T. in Salford, the Project Team addressed a range of initial and subsequent questions to the Trust. To support this research, two Project Team members and the C.H.C. Chief Officer made a visit to the E.C.T. Suite at Prestwich Hospital on Friday 22 November, 1996. They met with Mr. Les Hardy (Clinical Support Services Manager at the Mental Health Services of Salford N.H.S. Trust), Dr. Chetty (Consultant Anaesthetist at the Salford Royal Hospitals N.H.S. Trust) and Dr. Rosenberg.

Four members of the Project Team and the C.H.C. Chief Officer subsequently met with Dr. Gillian Moss (Consultant in the Psychiatry of Later Life) and Mr. Hardy on Friday 24 January, 1997, at the Ellesmere Unit, which is located on the site of Hope Hospital (the local teaching general hospital). At the time of the meeting at Ellesmere, the new E.C.T. Suite at Meadowbrook was not completed or in operation.

Two members of the Project Team and the C.H.C. Chief Officer visited the new E.C.T. Suite at Meadowbrook on 27 October, 1997, and were escorted by Ms. Avril Harding (Clinical Manager).

In the discussions, it was noted that the Trust did at one time have an E.C.T. Committee that met regularly, but that this was no longer the case.

3.2 Visits.

Following the discussion on 22 November, 1996, the visiting team were shown around the E.C.T. Suite at Prestwich Hospital. A range of things were noted:

The large, impersonal waiting room contained a number of cupboards, as well as chairs. There were some magazines, and also posters and leaflets about complaints and the C.H.C.

Patients are taken into the E.C.T. Suite one at a time, placed on a trolley and then taken through a curtain into the treatment area, with their head first.

The treatment area includes resuscitation equipment. Patients are given Diprivan anaesthetic and a muscle relaxant. A pulse oximeter is used.

There were several old posters on the wall of the treatment area – “Giving E.C.T. (Royal College of Psychiatrists, June 1985), a list of standard equipment, and a poster on cardio-pulmonary resuscitation.

The windows of the E.C.T. Suite enable people to see out but not in.

From the treatment area, patients are moved into the large recovery room, where they are moved by stages as they recover.

Patients end in a seating area, where tea, coffee and toast are available.

The E.C.T. Suite at Prestwich was brought out of use during 1997 when the new E.C.T. Suite at Meadowbrook was opened. A small visiting team was shown the new facilities on 27 October, 1997. These were located on the ground floor of the unit. A range of things were noted:

Of the patients now given E.C.T. at Meadowbrook, the vast majority were Salford residents, with 80-90% being inpatients.

The overall environment of the facilities was of a higher standard, although no less clinical than previous ones.

The waiting and recovery rooms were one and the same, although less imposing and cluttered than that at Prestwich.

The waiting / recovery room was divided from the treatment and recovery areas by a corridor which was used as a thoroughfare by staff.

The treatment area contained a lot of goods and equipment, although it was reported that shelving had been ordered for this.

New anaesthetic equipment had been obtained and was in use.

An Ectonus Series 5 E.C.T. machine was still in use. A new machine had been identified and ordered which would do brain traces and allow the voltage used to be age-related.

If required, the emergency resuscitation team would be called from the Heart Care Unit at Hope Hospital, adjacent to the unit, from which two doctors would be met at reception. Although full resuscitation facilities were in the E.C.T. Suite, the drugs required were held upstairs in Meadowbrook. There was no clearly available information for staff about the contact for the emergency resuscitation team.

3.3 The Use of E.C.T.

It took the Trust considerable effort to provide basic information about the use of E.C.T. It took several months to locate information about the use of E.C.T. at Meadowbrook / Glendale (previously The Lancastrian Unit) in 1988-1991 and in 1995, and could not give anything other than a crude analysis of the information it did have. This may, in part, have been due to the fact that the Lancastrian Unit remained part of Hope Hospital when the Mental Health Unit was established, thus splitting the organisation of psychiatry in the 1980s, with some based at Hope Hospital and another separate service at Prestwich Hospital.

During the visit to the E.C.T. Suite at Prestwich Hospital on 22 November, 1996, it was noted that recording of E.C.T. patients is kept only in A4 ruled feint books. No information technology is used. This makes is extremely difficult to monitor, audit or report on E.C.T. The Trust information system made is extremely difficult to document E.C.T.

3.3.1 Historical use:

The following figures show the historical use of E.C.T. within the Mental Health Services of Salford. It should be noted that Meadowbrook only came into being in 1991 (Glendale several years later). E.C.T. was previously given at The Lancastrian Unit at Hope Hospital.

Year
Meadowbrook/Glendale/Lancastrian Unit
Prestwich Hospital
Total
1986
609
895
1,504
1987
889
1,212
2,101
1988
511
1,023
1,534
1989
413
962
1,375
1990
287
825
1,112
1991
808
895
1,703
1992
723
646
1,369
1993
532
426
958
1994
395
364
759
1995
361
291
652
1996
78
456
524

There are no clear reasons for the variations over time in E.C.T. use. The Trust, however, reported that “in the past, the figures for E.C.T. were artificially inflated by individuals on the long stay wards being reviewed and diagnosed as having long-standing untreated affective disorders. Many of them required prolonged treatment with E.C.T. to relieve their long-standing illnesses. It was then possible to discharge a number of these patients from hospital. These changes in the number of patients being treated are a response to increasingly active earlier treatment for patients leading to a steady reduction in the number of patients receiving inpatient treatment from Salford. Many patients, particularly in the older age groups, now benefit from prophylaxis with lithium and/or carbamazepine which is closely monitored by a Domiciliary Drug Treatment Clinic. Theoretically this should reduce the relapse rate and consequently the need for E.C.T.” (Hyde, 1997: 6).

The Project Team was informed by consultants that in the Trust:

Many fewer patients now get E.C.T. because depression tends to be picked up earlier and more patients can tolerate the new antidepressants. The Elderly Service has expanded over the past 15 years from one consultant to three. This allows a better quality of maintenance of patients.

The declining or more appropriate use of E.C.T. is also due to the better training of psychiatrists. “The present generation of psychiatrists working in Salford have received excellent training compared to the last generation of ‘asylum psychiatrists’ and may well have a more realistic case load with consequent ability to spend more time with individual patients. ” (Hyde, 1997: 7).

According to responses to a survey in September 1997 by Psychology Politics Resistance as part of its North West Right to Refuse Electroshock Campaign, the use of E.C.T. within the Mental Health Services of Salford N.H.S. Trust compares with other N.H.S. trusts in Greater Manchester as follows:






































Year Meadowbrook/Glendale/Lancastrian Unit Prestwich Hospital Total
1986
609
895
1,504
1987
889
1,212
2,101
1988
511
1,023
1,534
1989
413
962
1,375
1990
287
825
1,112
1991
808
895
1,703
1992
723
646
1,369
1993
532
426
958
1994
395
364
759
1995
361
291
652
1996
78
456
524

Source:Psychology Politics Resistance – correspondence from N.H.S. trusts.

3.4 What conditions is E.C.T. used to treat?

The Project Team was informed by consultants that, in the Trust:

E.C.T. is used according to diagnosis, mainly for depression and rarely for conditions such as catatonic schizophrenia. It is used not necessarily always as a last resort, but when depression is very severe or that other treatments have produced negative results in the past for individual patients. In addition, some patients cannot tolerate antidepressants (although this is now less so with new drugs).

Most patients do not get E.C.T. because they respond themselves or with alternative treatments.

3.5 Who is given E.C.T.?

3.5.1 E.C.T. and gender.

The Project Team was informed by consultants in the Trust that the major indication for E.C.T. is depression and that this is more common in women than men. Dr. Moss said that this (together with the fact that women tend to live longer) accounted for the fact that women are more likely to receive E.C.T.

By gender, E.C.T. was given to patients within the Trust as follows:
1994

1995

1996

Age Group
Male
Female
Male
Female
Male
Female
Under 65
11
15
11
26
6
17
Over 65
14
37
17
28
8
26
Total
25
52
28
54
14
43
Percentage
32.5
67.5
34.1
65.9
24.6
75.4

On average over the three years, 69.6% of all patients who were given E.C.T. were female and only 30.4% male. This gender difference varied only slightly between the over-65 and under-65 groups.

According to responses to a survey in September 1997 by Psychology Politics Resistance as part of its North West Right to Refuse Electroshock Campaign, the use of E.C.T. by gender within the Mental Health Services of Salford N.H.S. Trust compares with other N.H.S. trusts in Greater Manchester as follows:

Trust
Female
Male
Mental Health Services of Salford
(9/96 – 9/97)
67%
33%
North Manchester Healthcare
(8/96 – 9/97)
67%
33%
Royal Oldham Hospital and Community Services
(1/96 – 12/96)
62.5%
37.5%
South Manchester University Hospitals (Withington Hospital)
(no dates given)
60%
40%
Trafford Healthcare
(no dates given)
49.3%
50.7%

Source:Psychology Politics Resistance – correspondence from N.H.S. trusts.

3.5.2 E.C.T. and age.

The Project Team was informed by consultants that the major indication for E.C.T. is depression and that this develops with age. Dr. Moss said that this accounted for the fact that older people are more likely to receive E.C.T.

The Trust reported that “it would be difficult and inordinately time consuming to break the patients down into age bands as this information is not one of the items that is kept in the E.C.T. recording book. It seems . . . sensible to arrange for this for the future.”

By age, E.C.T. was given to patients within the Trust as follows:
1994

1995

1996

Age Group
Under 65
Over 65
Under 65
Over 65
Under 65
Over 65
Male
11
14
11
17
6
8
Female
15
37
26
28
17
26
Total
26
51
37
45
23
34
Percentage
33.8
66.2
45.1
54.9
40.4
59.6

On average over the three years, 60.2% of all patients who were given E.C.T. were over 65 years and 39.8% under 65. This age difference varied only slightly between male and female patients.

According to responses to a survey in September 1997 by Psychology Politics Resistance as part of its North West Right to Refuse Electroshock Campaign, the use of E.C.T. by age within the Mental Health Services of Salford N.H.S. Trust compares with other N.H.S. trusts in Greater Manchester as follows:

Trust

Proportion of ECT patients by age
Mental Health Services of Salford (9/96-9/97)
under 16
0%

16-60
50%

over 60
50%
North Manchester Healthcare (8/96-9/97)
under 16
0%

16-60
60%

over 60
40%
Royal Oldham Hospital (1/96-12/96)
under 16
0%

16-65
64.3%

over 65
35.7%
South Manchester University (no dates given)
under 16
0%

17-64
86%

over 65
14%
Trafford Healthcare (no dates given)
under 16
0%

6-60
43.8%

over 60
56.2%

3.5.3 E.C.T. and people under 18 years old.

There was no evidence or report of E.C.T. being given to a young person under 18 years of age in Salford in the recent past.

3.5.4 Use by home district:

In regard to the home district of patients, assuming that some patients getting E.C.T. in the Mental Health Services of Salford come from outside the City, and that a few Salford people may be getting E.C.T. elsewhere, the figures from the Trust suggest a rate of use of approximately 250 – 280 treatments per 100 000 population. This is in the mid-range for reported rates of use across England and Wales.

During the visit to the E.C.T. Suite at Meadowbrook on 27 October, 1997, it was reported that of the patients then being given E.C.T., the vast majority were Salford residents

3.5.5 E.C.T. and ethnicity.

The Trust replied: “the recording of the use of E.C.T. by ethnicity and home district is again something that is not recorded. It would be possible to back track home districts to each patient by name by looking at their notes, but this would be an extremely time consuming exercise. As you are aware, ethnicity has only been recorded in the N.H.S. since April 1995 and again is something which is not recorded currently for E.C.T. I will arrange for this to be recorded in the future.”

Later, however, the Trust reported that “the Afro-Caribbean and Asian population within Salford at present is very small and the ethnic groups who are represented in significant numbers, for example, the large Jewish community in Higher Broughton, are not regarded as ethnic groups at all within the official N.H.S. categories. At present, information collected is appropriate for the tasks of the Trust. Other information is of course available in the patient’s notes. ” (Hyde, 1997: 7).

Reliable information on the ethnicity of the population of Salford is, in fact, limited. Its accuracy is also questionable due to under-reporting, especially among black and minority ethnic communities (for example, the Census form was produced in English only).

The 1991 Census and a later 1993 profile by Salford Community Health Council, Salford Family Health Services Authority and Salford Health Authority 144 reported the ethnic group of the Salford’s residents as:

Ethnic Group

1991 Census
1993 Profile

% of residents
Number (estimate)
Number (estimate)
White
97.8
215,613
225,740
Black Caribbean
0.1
220
50
Black African
0.1
220
110
Black other
0.2
441
-
Indian
0.4
882
1,250
Pakistani
0.3
661
800
Bangladeshi
0.1
220
250
Chinese
0.3
661
750
Other Asian
0.1
220
-
Other
0.5
1,102
1,050
Total
100
220,463
230,000

Table 3:Salford population by ethnicity (117,144)

Clearly, these figures do not reflect “white minorities”, such as people of Irish, Jewish and East European descent. They make up a significant proportion of the total population.

According to responses to a survey in September 1997 by Psychology Politics Resistance as part of its North West Right to Refuse Electroshock Campaign, the use of E.C.T. by ethnicity within the Mental Health Services of Salford N.H.S. Trust compares with other N.H.S. trusts in Greater Manchester as follows:

Trust
% of ECT patients
White
% of ECT patients
Ethnic Minority
Mental Health Services of Salford
(9/96 – 9/97)
97.9%
2.1%
North Manchester Healthcare
(8/96 – 9/97)
91.0%
9.0%
Royal Oldham Hospital and Community Services
(1/96 – 12/96)
94.6%
5.4%
South Manchester University Hospitals (Withington Hospital)
(no dates given)
95.0%
5.0%
Trafford Healthcare
(no dates given)
98.6%
1.4%

Source:Psychology Politics Resistance – correspondence from N.H.S. trusts.

3.6 Administration of E.C.T.

3.6.1 Good practice and guidelines.

The C.H.C. requested the clinical and non-clinical criteria and guidelines used within the Trust for E.C.T. The response from the Trust was that “it is difficult to give clinical and non-clinical guidelines for the use of E.C.T., as E.C.T. is given as a medical treatment on the clinical judgement of the prescriber and it is therefore a clinical decision in each case.”

It was also reported by the Trust that “there are no specifications on standards of guidelines about E.C.T. contained in contracts held by the Trust with purchasers.” Thus, it can be concluded that no guidelines are in operation for the use of E.C.T., with judgements left to individual clinicians.
There are written guidelines from the Anaesthetics Department.” The anaesthetic guidelines of January 1990 were updated in November 1996, during the course of the Project. Both versions are attached at Appendix One. The Project Team was told that these were still the only guidelines for E.C.T.

This response made no reference to the procedure for E.C.T. developed by the Mental Health Unit of Salford Health Authority (which became the Mental Health Services of Salford N.H.S. Trust) in 1993, nor its updated version, Procedure: Electro-Convulsive Therapy (E.C.T.) (July 1996 – review date July 2000) (see Appendix Three).

It was not until the Project Team specifically asked about this documents it was either provided or referred to. While the procedure had been updated (albeit significantly later than the review date set on the original versions), the lack of reference to it in any of the discussions or correspondence with the Trust raises a question about staff awareness and implementation of it.

3.6.2 Equipment.

Dr. Moss stated that the E.C.T. machines within the Trust are “obsolete and unsatisfactory” and that it does not have any “modern” machines.

The Trust informed the C.H.C. that the following E.C.T. machines were in use at Prestwich Hospital as at February 1997, and were to be moved to Meadowbrook when the E.C.T. facilities transferred there later in 1997:

Ectonus Series 5-regular machine

Ectron CCX-reserve

Duopulse (2c/
-used only if both other machines fail.

Ectonus (2c/

It should be noted that the Ectonus Series 5 machine had been superseded by the Ectonus Series 5A. The Duopulse E.C.T. machine has long been superseded by a more modern device.

During the visit to the Prestwich E.C.T. Suite on 22 November, 1996, the Project Team were told that staff wanted a new E.C.T. machine that could also measure E.E.G. This may be significant, as E.E.G.-based seizure times are estimated to be 10 – 40 % longer than seizure times by observation of muscle activity (using the Cuff Technique to control for the muscle relaxant) (59) (98).

When the C.H.C. visited the E.C.T. Suite at Meadowbrook on 27 October, 1997, the Ectonus Series 5 E.C.T. machine was still in use. Staff involved in the administration of E.C.T. considered that a new machine capable of providing E.C.G. monitoring was required. The short list included a Mecta SR1, a Mecta SR2 or a Thymatron DGX, although on 29 October, 1997, the Vickers Company stopped sales of the Mecta machines and terminated their contracts with the makers, as they were found to be possibly dangerous (48). Following demonstrations and using guidance from the Royal College of Psychiatrists, a new machine had been identified and ordered which would do brain traces and allow the voltage used to be age-related.

The servicing of E.C.T. machines is also a concern of many. According to responses to a survey in September 1997 by Psychology Politics Resistance as part of its North West Right to Refuse Electroshock Campaign, the servicing of E.C.T. machines within the Mental Health Services of Salford N.H.S. Trust compares with other N.H.S. trusts in Greater Manchester as follows:

Trust
Servicing period for E.C.T. machines
Mental Health Services of Salford
One year
North Manchester Healthcare
Six months

Royal Oldham Hospital and Community Services
Six months
South Manchester University Hospitals (Withington Hospital)
“Regularly in line with the manufacturers’ recommendations”.

Trafford Healthcare
One year

Source: Psychology Politics Resistance – correspondence from N.H.S. trusts.

3.6.3 Frequency and number of treatments.

The Project Team was told by consultants that in the Trust, although fewer patients now get E.C.T., those that do probably receive a similar number of treatments and for similar lengths of time to patients in past years.
While no direct information was provided by the Trust, use of the figures provided produces the following average number of treatments per patient:

Year
Total number of treatments
Total number of patients
Average treatments per patient
1994
759
77
9.86
1995
652
82
7.95
1996
524
57
9.19

Allowance may have to be made for the small number of patients who received more than one course of treatment during any year. It is, however, unclear whether this distinction is made when data is collected and whether such information is readily available.

3.6.4 Anaesthesia.

The C.H.C. requested the clinical and non-clinical criteria and guidelines used within the Trust for E.C.T. The response from the Trust was that “it is difficult to give clinical and non-clinical guidelines for the use of E.C.T., as E.C.T. is given as a medical treatment on the clinical judgement of the prescriber and it is therefore a clinical decision in each case.”

There are written guidelines from the Anaesthetics Department.” The anaesthetic guidelines of January 1990 were updated in November 1996, during the course of the Project. Both versions are attached at Appendix One. The Project Team was told that these were still the only guidelines for E.C.T.

The guidelines for anaesthesia for E.C.T. in the Mental Health Services of Salford N.H.S. Trust varied significantly from those used for day surgery in the Salford Royal Hospitals N.H.S. Trust, even though the anaesthetists in both cases are employed by the Salford Royal Hospitals. [See Appendix One].

Only post-fellowship or consultant anaesthetists were allowed to be involved in E.C.T.

Anaesthesia varies according to the patient’s condition.

3.7 Training of Clinical Staff.

3.7.1 Training of staff:

Discussions with clinical staff in the Trust highlighted that:

At the time of the C.H.C.’s first review, doctors (except anaesthetists) got no specific or formal training in E.C.T. This situation began to change after the relocation of the service from Prestwich to Meadowbrook.

While the E.C.T. service was at Prestwich (1996-1997), E.C.T. was administered almost entirely by Dr. Rosenberg with assistance from trainees in Old Age Psychiatry who were all experienced in the administration of E.C.T. Specific training was not provided to junior doctors as they were not required to administer E.C.T.” (Hyde, 1997: 7).

From April 1997, “trainee psychiatrists based at Meadowbrook [had] been involved in the administration of E.C.T. and were all offered individual training in the use of the E.C.T. box. They were experienced trainees having worked in other hospitals and had been trained in administering E.C.T., and none have taken up this invitation.” (Hyde, 1997: 7-8).

From 1 August, 1997, all junior doctors on the rotation were required to complete a log book defining the experience they had, as well as to develop a learning contract within the first month of their attachment with the Trust. Both of these documents should be reviewed by the Postgraduate Dean’s Department in reviewing their training. These were intended to act as checks to ensure that doctors administering E.C.T. received the appropriate training 79.

On the C.H.C.’s visit to Meadowbrook on 27 October, 1997, it was reported that were still junior doctors applying E.C.T. who had not been trained in its use, although assurances were given that all doctors would be trained on the use of the new machine when it was obtained and that this training would be repeated by a consultant psychiatrist every six months when new junior doctors arrived.

There were two regular nursing staff at the Prestwich E.C.T. Suite, both of whom were registered mental nurses (R.M.N.s).

3.8 Variations in use and practice.

The use of E.C.T. by consultant was as follows:

In the under-65 services:

Consultant

Meadowbrook
1994

1995

1996

Male
Female
Male
Female
Male
Female
Dr. Black
0
2
0
2
0
1
Dr. Callender
1
0
1
2
0
0
Dr. Colgan
0
4
0
5
1
4
Dr. Kelly
3
5
1
0
-
-
Dr. Soni
2
1
3
5
1
0
Dr. Stone
2
3
1
5
0
0
Prestwich

Dr. Black
0
0
1
0
0
0
Dr. Campbell
1
0
0
0
-
-
Dr. Colgan
0
0
1
1
0
4
Dr. Davison
-
-
-
-
0
1
Dr. Holloway
1
0
0
2
0
0
Dr. McGloughlin
-
-
-
-
0
1
Dr. Monteiro
1
0
1
0
0
0
Dr. Soni
0
0
2
2
3
5
Dr. Stone
0
0
0
2
0
1
Dr. Wilson
-
-
-
-
1
0
Totals
11
15
11
26
6
17

In the over-65 services:

Consultant
1994

1995

1996

Meadowbrook

Dr. Moss
0
2
6
5
0
0
Dr. Stout
6
10
5
9
4
8
Prestwich

Dr. Atkins
-
-
-
-
0
2
Dr. Davenport
0
1
0
2
0
1
Dr. James
0
1
0
0
0
0
Dr. Jolley
0
1
0
0
0
0
Dr. Moss
1
1
3
1
0
4
Dr. Stout
7
21
3
11
4
11
Totals
14
37
17
28
8
26

These figures make interesting reading, not least in the variations both for individual consultants year-on-year, but also between consultants. The reasons for these variations are unclear and warrant further investigation.

Discussions with consultants within the Trust highlighted that:

There is no information held by the Trust on the variations in use of E.C.T. between consultants and hospitals, although some of this may be due to differing clinical judgements.

There was no work known by them in England and Wales to allow comparison of E.C.T. provision in different N.H.S. trusts, or any work similar to that being undertaken in Scotland.

3.9 Effectiveness of E.C.T.

3.9.1 Clinical Audit and Research.

Within the Trust, clinical audit had been undertaken in regard to E.C.T., but this was only a single audit in 1992 about its administration rather than outcomes. The Project Team was told by consultants in the Trust that:

the recent reorganisation of the Elderly Service had left things somewhat disorganised, but it was felt that a suggestion should be put to Salford and Trafford Health Authority to seek an audit of E.C.T.

Although the Salford Case Register records information on research and audit, this appears irrelevant in the case of E.C.T., as so little research and audit has actually been undertaken.

3.9.2 Duration of Effect.

The Project Team was told by consultants in the Trust that:

Psychiatrists would look for a quick difference as a result of E.C.T. – an effect after two weeks. It would be difficult to check the effectiveness for patients having E.C.T. against those who do not.

The relapse rate of patients is fairly high, perhaps 60% within two years. E.C.T. should therefore always be followed up with maintenance treatment.

The Project Team was informed that “Psychiatrists in Salford do not prescribe E.C.T. expecting that this will reduce the rate of relapse. Psychiatrists in Salford do not prescribe E.C.T. to prevent long-term relapse. The Royal College of Psychiatrists’ Committee on E.C.T. emphasise that it is essential that maintenance of the treatment with medication should be instituted after a course of E.C.T. to reduce the risk of relapse. This may be with antidepressants, lithium, carbamazepine or a combination.” (Hyde, 1997: 5).

3.9.3 Survivors’ Views.

No work had ever previously been done in Salford to assess patients’, survivors’ or relatives’ views about E.C.T. and its use.

3.9.4 Who does E.C.T. work for?

On criteria to determine the effectiveness of E.C.T., the Project Team was told by consultants in the Trust that a major factor they used to decide how effective E.C.T. is likely to be for any patient is the presence of delusion and also biological symptoms. Both can, of course, be seen as matters of judgement rather than objective fact.

A depressive delusion involves a person believing that they are worthless, unlovable and not deserving of care or attention. In such a psychological state, there is no logical reason to continue to live, and the person will believe that everyone is better of without them. A delusion is a belief that cannot be questioned.

Biological symptoms are those which suggest a depressive illness that is not a response to grief, a lack of self-confidence or a lack of coping skills, but one that is related to biochemical and pathological changes in the brain and body.

3.9.5 E.C.T. and Alternatives.

The Project Team was informed by consultants that in the Trust the alternatives to E.C.T. used are mainly antidepressants. There was no mention of psychological services, “talking treatments” or other alternatives. This was despite the presence in the Mental Health Services of Salford of both a Psychotherapy Department and also a large, highly-trained Psychology Department that offers cognitive therapy and various other treatments that can be used to treat depression, either with or without physical treatments.

It was, however, reported that “In considering alternative treatments to E.C.T., it should be noted that patients treated with E.C.T. are normally too ill to be accessible to psychological treatments. These are available and will be considered where appropriate either when someone who has been severely depressed has improved or for an individual with a less severe depressive illness for whom E.C.T. would not be considered. Many individuals with depressive illnesses have a biologically determined illness and are not necessarily in need of psychological treatment.” (Hyde, 1997: 8).

The C.H.C. was later informed that “When contemplating E.C.T. in Salford, we consider not only alternative pharmacological treatments but the availability of both eclectic psychological treatments, and specific psychological treatments of cognitive behavioural therapy and psychodynamic therapy. The majority of people receiving E.C.T. are not amenable at that time to psychological treatments.” (Hyde, 1997: 5).

3.10 Risks and Side Effects of E.C.T.

3.10.1 Risk assessment for E.C.T.

The Project Team was told by consultants in the Trust:

On a patient’s first referral, an anaesthetist makes an assessment, including investigations. E.C.T. is only allowed if the anaesthetist is satisfied it is safe to do so. The final decision on whether a patient can be given E.C.T. is that of the anaesthetist, who takes into account the consultant’s view.

Older people are at a higher risk, especially if they have heart disease. If a patient’s physical health is borderline, the anaesthetist will check with the consultant psychiatrist about the decision to give E.C.T. (although this does not happen often). Problems with heart conditions, falls and strokes (even in older people) are few.

There is no evidence that E.C.T. has ever been given in a coronary care unit or intensive care unit in Salford 79.

3.10.2 Side Effects of E.C.T.

The Project Team was told by consultants that in the Trust, there was currently no mechanism in place for monitoring the side effects of E.C.T., including memory loss. Dr. Moss felt that differences were individual to patients. This should be an important area for further research to be undertaken.

3.10.3 Anaesthesia.

The anaesthetists used by the Mental Health Services of Salford N.H.S. Trust are employed by the Salford Royal Hospitals N.H.S. Trust. The service involves four E.C.T. consultant anaesthetist sessions. During the period of the project, the source funding for these was an unresolved issue, with sessions being cancelled and discharges being delayed. A service level agreement was drafted to improve the situation, although this had extra funding implications.

The Project Team was told by consultants that:

No day case surgery in undertaken on patients over 75 years in the Salford
Royal Hospitals N.H.S. Trust, but E.C.T. is undertaken on patients older
than this in the Mental Health Trust. Greater monitoring of E.C.T. patients
may be required.

Repeated anaesthesia has no cumulative effect, as only has a short-term effect. Repeated anaesthesia does, however, increase the level of risk.

3.10.4 E.C.T. and Death.

The Project Team was told by consultants that death and serious injury due to E.C.T. are very rare. There had been no instances in the Trust in at least the previous 18 months. In the past there had been two or three deaths, but these were of people who would probably have died any way.

3.11 Consent to Treatment.

3.11.1 Rules and Guidance.

The local guidance on consent within the Mental Health Services of Salford N.H.S. Trust in force at the time of the Project was:

Procedure: Consent to Treatment (March 1995) – review date October 1999: see Appendix Two; and

Quality Statement: Consent to Treatment (Mental Health Act 1983) (February 1994) – review date February 1999: see Appendix Four.

It was not until the Project Team specifically asked about these documents that they referred to by the Trust. While the procedure and quality statement had been updated (albeit significantly later than the review dates set on the original versions), the lack of reference to them in any of the discussions or correspondence with the Trust raises a question about staff awareness and implementation of them.

On the question of consent, the Mental Health Act 1983 and the Mental Health Act Code of Practice provides the essential framework. Many statements from these are reproduced in the Trust’s procedure guidance and quality statement.

If a patient is able and willing to give consent to E.C.T. and anaesthesia, they are then asked to sign a standard N.H.S. consent form, which is countersigned by the R.M.O. The Trust actually provided the C.H.C. with a consent form specific for E.C.T. [Appendix Three]. This identifies that the E.C.T. treatment has been explained. The form should be checked by the medical staff giving the E.C.T. and anaesthetic and by the nursing staff. Treatment should not be given without a valid consent form being provided.

The treatment course is reviewed weekly by the R.M.O. and the multi-disciplinary team. Competence to give or refuse consent is not formally assessed prior to each individual session. Consent is, however, reaffirmed by the patient at each treatment by his/her confirmation to the named nurse or nurse in charge prior to each treatment that they will be attending for that treatment and not by mere assent or being there.

While some patients’ capacity to consent may vary over time, their right to refuse treatment should always be observed. Any attempts at persuasion should involve only discussion and reason without undue pressure. If a patient does refuse E.C.T., alternative treatments should be continued, along with an explanation of the associated benefits and risks.

If a patient refuses to give consent or their consent is clinically judged to be not valid, the R.M.O. has to make a clinical judgement as to whether to carry on with the treatment under the Mental Health Act, in line with the Code of Practice. In the case of patients who are given E.C.T. without their consent, the authority of a Second Opinion Appointed Doctor (S.O.A.D.) from the Mental Health Act Commission to do this must be recorded on a Form 39. This should accompany the patient. Without it, the patient should not be given any treatment. E.C.T. staff also have a responsibility to check the number of treatments the patient is given against the specified number authorised by the S.O.A.D.

During Mental Health Act training, staff are taught about the withdrawal of consent. This can be done not only by a patients saying that they do not want the treatment, but also by action, such as refusing to get on a trolley or not putting their arm out for the anaesthetic. To give treatment in these circumstances (unless the Mental Health Act is fulfilled) would be illegal.

3.11.2 Information and Explanations.

In 1996, the Trust reported that “there is no written information given to patients regarding E.C.T. E.C.T. is individually discussed with each client by the doctor prescribing it. It is also backed up with discussions by nursing staff and also by E.C.T. staff when then patient first comes for treatment.”

Clinical staff also told the Project Team that information for patients and the obtaining of consent to treatment was not standardised within the Trust.

During discussions with clinical staff in the Trust, the Project Team was told that no written information is given to patients about E.C.T. At present, the only explanation for E.C.T. was verbal. All information is given verbally, and is thus dependent on staff, their communication skills and the way in which the information is presented. A new form and set of criteria were required. It was noted that the Royal College of Psychiatrists had produced videos illustrating “ideal interviews”.

At the time of the visit to the E.C.T. Suite at Meadowbrook on 27 October, 1997, the C.H.C. team was told that patients should be given the Royal College of Psychiatrists’ leaflet by ward staff, although this was probably more likely to be on request than automatic.

This situation was in contrast to that when Salford C.H.C. enquired about this in 1994, when it was provided with a copy of the Royal College of Psychiatrists E.C.T. (Electroconvulsive Therapy) A Factsheet for You and Your Family dated 12 July, 1993, and marked for the Meadowbrook Department of Psychiatry of the Mental Health Services of Salford.

The Trust indicated that the information as suggested by Mind “would be very useful for patients or their relatives to ask about E.C.T. These reports of survivors and the comments about validity of consent make disturbing reading and should be read by doctors prescribing E.C.T. . . . We will explore with the staff administering E.C.T. the development of a small pamphlet addressing these questions and providing some written information.” (Hyde, 1997: 6).

3.11.3 Validity of Consent.

The process of obtaining valid consent from a patient is based on the clinical judgement of their responsible medical officer (R.M.O.). If they and the clinical team consider that a course of E.C.T. treatments would be beneficial, this should be discussed with the patient and, where appropriate, their relatives. Under the Patient’s Charter, patients should be given a full explanation, including about the benefits, risks and alternatives. Nursing staff can have an important role in this process. The Trust is expected by the local Health Authority to audit and report on performance against this standard.

The Trust includes obtaining valid consent as an integral part of its Mental Health Act training updates.

The Project Team was informed by Trust staff that there is no independent advocacy available to patients who are offered or given E.C.T.

3.11.4 E.C.T. Without Consent.

The Project Team was told by Trust staff that treatment without consent is monitored by the Mental Health Act Commission, including against the Mental Health Act Code of Practice.

4. Patients’, Users and Survivors’ Views in Salford.

4.1 Background.

The Project Team tried several different approaches to obtaining the views of survivors of E.C.T. from the start of the Project. These included press releases, articles in local press and media (including voluntary sector and mental health publications), and direct letters and mailings to mental health user groups and carers’ organisations. These yielded, however, only two people, both of whom were coopted onto the Project Team.
The Project Team felt it vital that every effort was made to obtain the views of people who had had E.C.T. in Salford. It therefore met with Survivors in Salford, the only city-wide organisation of mental health service users to discuss possible ways forward. From this discussion, it was agreed to hold a workshop and to invite survivors, users and carers to come to give their views. This was a format that had been used successfully by Survivors in Salford before on other mental health issues.

4.2 Planning and Publicity.

The workshop was promoted and publicised through the press and media (including articles in local newspapers and interviews on B.B.C. local radio), and through the distribution of 1 500 flyers targeted at survivors through user groups, carers’ groups, community psychiatric nurses, health centres, social workers, support workers, drop-ins and libraries. The mailing list for Marooned?, the mental health magazine for Salford, and the Salford Council for Voluntary Service Directory of Local Information were used to assist with distribution. The flyers included information about lunch and the reimbursement of travel expenses.

4.3 Letters and Telephone Calls.

As well as participants on the day, the publicity for the workshop also attracted a range of letters and telephone calls from E.C.T. survivors to Salford Community Health Council (C.H.C.). These included:

A survivor who had had two courses of E.C.T. in 1997 for manic depression. They considered that it had saved their life, but was worried about the side effects.

A survivor who had had several courses of E.C.T. at Prestwich Hospital over 16 years, the first after being diagnosed schizophrenic. After the first courses of treatment, it had taken two years to recover. Later, when the person decided not to have E.C.T., it took them eight years to reach the same level. “I think you recover quicker with E.C.T. and it cuts the amount of time you are suffering”.

A survivor who had recently had E.C.T. at Meadowbrook, reportedly for continuous earache, and who withdrew their consent after a small number of treatments. They described the experience as “awful” and as “a quick conveyor belt process”. “Came out of Meadowbrook worse than when I went in. Just a handful of anti-depressants and hope these kept me quiet. Sorry, against E.C.T.”.

A survivor who had had over 100 E.C.T. treatments at both Prestwich Hospital and Meadowbrook. They reported that, for them, three or four “bouts” helped and that the treatment was followed by a headache, but no memory loss. They said that E.C.T. “lifts a cloud from you and lets the sunlight through”.

A survivor who estimated that they had had at least 150 E.C.T. treatments. They reported short-term memory loss, especially for the first 6-7 days after treatment, but that this improves over time. They wrote that “I think it’s a small obstacle, compared with not having my sanity . . . If they banned E.C.T. I’d be terrified for the rest of my life.”

A son whose mother had had five or six E.C.T. treatments about ten years before while in her eighties for post-influenzal depression, and then again after two and four years. He said that, after each course of treatment, she was “right as rain”. His mother was now in good health, very sprightly for her age and with a good memory.

A survivor who had E.C.T. nine years before after a nervous breakdown. This had consisted of only one treatment, due to her husband stopping further treatment, as she had had a fit while going for the second. She now had permanent epilepsy, even though there were no family history of this. She believed that the epilepsy was caused by the E.C.T.

A survivor who had had course of seven E.C.T. treatments. She complained of having vivid and alarming dreams since E.C.T., a poor memory, difficulty in thinking, and problems with both sleeping and cooking.

4.4 The E.C.T. Workshop.

The workshop was held on Wednesday 22 October, 1997, at the Banqueting Suite at Buile Hill Park in Salford. This is a central venue often used for meetings of mental health survivors, which is well away from any hospitals and mental health facilities.

A full lunch was provided at the workshop. Travel expenses reimbursed to all those who wished to claim. Funding for the event was shared between the Mental Health Services of Salford N.H.S. Trust, Salford C.H.C. and Survivors in Salford. Information stalls about Salford C.H.C. and E.C.T. Anonymous were also on show throughout the day.

The workshop attracted 33 participants. It was jointly chaired by Ken Stokes, Vice-Chairperson of Salford Community Health Council and a member of the Project Team, and by Pat Garrett, the Chair of Survivors in Salford. The morning session was for users, survivors, relatives and carers only. This was to allow them to express their views freely and without any fear or pressure of doing this with health professionals present.

4.4.1 The E.C.T. Workshop – Morning Session.

Ken and Pat welcomed everyone to the event, explained the role of both organisations and the purpose of the event, and stressed the need for everyone to listen to each others’ views and respect each other’s confidentiality.

Chris Dabbs, the Chief Officer of Salford C.H.C., then gave a brief presentation on the aims and objectives of the Project and the issues that had been highlighted to date. He was followed by Pat Butterfield and Andrew Bithell from E.C.T. Anonymous, a national support and pressure group for all E.C.T. survivors and their helpers. They gave their own views on E.C.T. and its use in the United Kingdom. The audience then asked a range of questions about E.C.T. and the Project.

Four discussion groups were then formed. Facilitation and the taking of notes were undertaken by a Member and officers of the C.H.C., members of Survivors in Salford and members of E.C.T. Anonymous. Each group was given a “prompt sheet” – a list of the issues thrown up by the Project Team’s work to date – to help and inform their discussions.

Each group was asked to identify three issues that they wished to highlight to the representatives of the Mental Health Services of Salford N.H.S. Trust during the afternoon session. These were:

Change the law to give all patients a right to choose or refuse E.C.T.
All patients should have access to an advocate when offered E.C.T. and during a course of E.C.T.

All alternatives, especially talking treatments, should be offered before E.C.T. is considered.

Better long-term monitoring of patients after E.C.T. and long-term research into its effectiveness and side effects.

Concerns about E.C.T. particularly being given to older people and women – was there discrimination involved?

Health professionals to listen to patients and survivors more, both as individuals and as groups.

Better and more information for patients and relatives about E.C.T., with the maximum possible time being given to consider it before making a decision about whether to have E.C.T. This information should include views from psychiatrists and survivors, giving views both supporting and opposing E.C.T.

Greater distinction between physical and mental illness – some people reported being given E.C.T. for conditions that were physical and not mental.

To use only the most recent, up-to-date equipment for E.C.T., with this being tested and maintained on a frequent and regular basis.

A vegetarian lunch was served. During the lunch interval, survivors’ poetry was performed by Survivors’ Poetry Manchester,

4.4.2 The E.C.T. Workshop – Afternoon Session.

Dr. Steve Colgan and Ms. Avril Harding from the Mental Health Services of Salford N.H.S. Trust arrived at the start of the afternoon session. Chris Dabbs from the C.H.C. then presented the main issues highlighted by the discussion groups.

The question and answer session elicited the following responses from Dr. Colgan and Ms. Harding:

Most patients who are given E.C.T. without their consent are actually not able to give or withhold their consent.

There is a tension between seeking an absolute right to refuse E.C.T. and situations where the patient’s judgement is impaired and they are suicidal.

The debate on the right to refuse E.C.T. needs wider moral and ethical discussion of the competing views.

Many patients at Meadowbrook were not aware of the independent advocacy service provided there by the Salford Mental Health Services Citizen’s Advice Bureau. This service is not available to patients in the Elderly Service.

The main general risk with E.C.T. is that associated with repeated general anaesthesia.

E.C.T. is more commonly used in older people as they tend to respond well to E.C.T. and find drugs more noxious than younger people.

There is a need to listen more to and take more account of the views of patients.

Patients and carers should have as much information as they want about E.C.T. The Trust was developing a new leaflet on E.C.T.

The very high concurrence rate between the views of responsible medical officers (R.M.O.) and second opinion appointed doctors (S.O.A.D.) was because they were trained to the same standard.

The Trust recognises that there are still problems. It wants to continue to discuss the local service with survivors and carers in order to help make improvements.

The Trust was currently commissioning new E.C.T. equipment for the new E.C.T. Suite at Meadowbrook. Older E.C.T. were still being used, but were not considered dangerous and were maintained regularly and had not broken down since the new E.C.T. Suite had opened.

The period of time given to decide whether to give or withhold consent varies according to circumstances, but is as long as safe and possible.

It is recognised that one side effect of E.C.T. can be memory loss (at least in the short term). Long-term memory loss is rare and difficult to determine.

Compared to other alternative treatments, E.C.T. is better researched.

E.C.T. practice has improved over time, including in regard to machinery, anaesthetics, privacy and dignity.

5. Conclusions.

A. E.C.T. and Its Use in England and Wales.

5.1 E.C.T. and its use.

1. E.C.T. is perhaps the most controversial treatment currently used by the medical profession. Many patients, survivors, relatives, professionals and others have serious concerns about the use of electro-convulsive therapy. While some survivors report it as helpful or lifesaving to them, many others see it as a damaging and threatening tool of psychiatric oppression.

2. E.C.T. is used mainly to treat depressive disorders, but also mania, schizophrenia and neuropsychiatric conditions. It is also reported as having been used for a variety of other conditions for which its use is not generally clinically indicated.

3. E.C.T. has cardiovascular, cerebral, intraocular and intragastric effects in patients.

4. There are a range of theories about how E.C.T. works. There is no firm evidence to demonstrate how the process operates.

5. Most patients receive E.C.T. two or three times per week as part of a course of treatments which usually number between two and 12. There is some evidence that E.C.T. given twice per week is as effective as E.C.T. three times per week and has less severe cognitive effects. A significant number of patients receive several courses of treatment over time.

6. About 22 000 people are given E.C.T. in England each year. This is a rate considerably higher than other countries in Europe, some parts of North America and the Far East.

7. Women are far more likely to be given E.C.T. than men, at a ratio of about 2:1.

8. Older people (especially those over 65) are more likely than younger people to get E.C.T., the average age of patients being somewhere in their fifties.

9. E.C.T. is rarely given to people under 18 years, with no evidence of its use for children under 12.

10. There is no reliable information about the use of E.C.T. in regard to the ethnicity of patients.

5.2 Effectiveness of E.C.T.

1. Clinical studies tend to concentrate on (short-term) symptom reduction rather than on the quality of life, physical health or social functioning of survivors.

2. There is very little good research on the long-term effectiveness or side-effects of E.C.T.

3. E.C.T. is demonstrably effective for a narrow range of severe psychiatric disorders in a limited number of diagnostic categories: delusional and severe endogenous depression and manic and certain schizophrenic syndromes.

4. Most clinical research concludes that E.C.T. is effective for the treatment of depressive illness and is preferable to drugs for some patients.

5. Clinicians generally hold that E.C.T. is particularly effective for patients with a higher number of typical features of depressive illness, especially where these include psychotic features. It is also reported that two particular symptoms – retardation and depressive delusions – respond well to E.C.T. and that patients without these symptoms do not benefit significantly from E.C.T.

6. E.C.T. is not effective in treating Type II (chronic) schizophrenia and has only a limited use in treating Type I (acute) schizophrenia in patients with specific indicators.

7. E.C.T. is effective in treating people with affective and catatonic disorders, but only where there is account taken of specific medical risks and appropriate modifications made.

8. There is little evidence for the use of E.C.T. in treating either Parkinson’s Disease or epilepsy.

9. There are no symptoms or clinical features proven as criteria to determine who will benefit from E.C.T., although most recent work indicates that psychotic features and psychomotor disturbance (rather than the severity of depression) are best correlated with a good response for E.C.T.

10. E.C.T. can prevent death when a person is severely depressed and is in a critical state through no longer eating or drinking.

11. There is no good evidence to prove that E.C.T. prevents suicide or affects the suicide rate.

12. E.C.T. is not effective for violent or offending behaviour, diabetes, obsessive-compulsive disorders, anxiety, post-traumatic stress disorder, stroke, dementing illnesses or cardiovascular disease.

13. There has been relatively little work done to establish survivors’ views on E.C.T. Some of the research that has been undertaken is of poor quality.

14. From the limited surveys undertaken, between 30% and 43% of survivors report E.C.T. as being helpful or life-saving to them. Between 37% and 51% of survivors found E.C.T. unhelpful or damaging. Factors which appear to increase the proportion of patients finding E.C.T. helpful are:

-being treated voluntarily rather than compulsorily

-being treated with one’s consent rather than without consent

-E.C.T. not being used as a threat

-being given a full explanation before E.C.T.

-diagnosis: more people diagnosed with depression report positive outcomes than people diagnosed with schizophrenia, more of whom in turn report positive outcomes than people diagnosed with manic conditions.

15. The beneficial effects of E.C.T. are rapid and only short-term (at most eight weeks).

16. There is a high relapse rate within the first four months after E.C.T., and an even higher rate in the longer term.

17. There is no high quality research to support the use of “continuation” or “maintenance” E.C.T.

18. E.C.T. has no positive long-term effect and does not positively influence long-term survival. Indeed, it has been argued that index E.C.T. treatment predicts high long-term mortality and readmission risks.

19. When effective, E.C.T. relieves only the symptoms of depression and is ineffective in treating depressive illness itself. There is no evidence that it helps patients to deal with their underlying problems more effectively.

20.There is very little good research on the effects of different medications on the efficacy and safety of E.C.T. for patients, although at least some drugs may reduce the effect of E.C.T.

5.3 Risks and side-effects of E.C.T.

1. Guidance very strongly advises against giving E.C.T. to patients who have had a recent myocardial infarction (heart attack), a recent cerebrovascular accident (stroke) or an intracranial mass or lesion (brain injury or tumour).

2 .Relative contraindications for E.C.T. are: angina, congestive heart failure, severe pulmonary disease, severe osteoporosis, major bone fractures, glaucoma, retinal detachment, thrombophlebitis and pregnancy. Heart disease in particular produces much greater risks for patients having E.C.T. There are many other side effects reported by survivors.

3. The greatest risks of E.C.T. are probably those associated with the regularly repeated general anaesthesia which is given.

4. There are divided opinions on whether E.C.T. causes brain damage.

5. The research into the relationship between E.C.T. and deaths caused by it tends only to concentrate on very short-term time scales. The risk of death from E.C.T. ranges from 0.002% to 0.0045%, although it is argued that many deaths are not reported or not linked to the administration of E.C.T. The risk of death is higher in older people than younger ones.

6. The immediate side effects of E.C.T. commonly include: amnesia, drowsiness, confusion, disorientation, apathy, physical weakness, headaches, nausea and dizziness. For older people, there are particular risks of heart problems, falls and strokes.

7. Memory loss or impairment is the most commonly reported side effect of E.C.T. Most survivors experience some short-term memory impairment, while a significant proportion report longer-term or permanent memory loss. Many survivors report that clinical staff tend to be rather dismissive of these complaints.

8. The level of memory impairment varies, at least in part, according to E.C.T. technique, with bilateral E.C.T. appearing to cause more severe memory loss than unilateral E.C.T., although the latter may cause more severe damage to the patient’s brain.

9. Sine wave E.C.T. appears to cause more damage to patients than brief-pulse E.C.T.

10. The emotional and psychological effects of E.C.T. are often underestimated or ignored.

11. The Royal College of Nursing’s E.C.T. – Guidance for Nurses identifies a range of measures that can reduce the anxiety of patients before E.C.T. and the level of memory impairment afterwards, including: management of anxiety; management of cognitive side-effects of E.C.T.; the type of information more likely to retained; and care planning.

5.4 E.C.T. and alternative treatments.

1. E.C.T. is not always used as a treatment of last resort before all other alternatives have been tried. This is, at least in part, due to the extreme severity of the condition of some patients.

2. In most cases, most psychiatrists see the prescription of drugs as the only real alternative to E.C.T. Relatively few patients (especially older people) are offered other (non-drug) therapies and many are offered no alternative at all.

3. There is little good research or evidence to demonstrate the relative effectiveness of E.C.T. and alternative treatments.

5.5 Rules, guidance and criteria for E.C.T.

1. The most widely accepted guidance for E.C.T. is The E.C.T. Handbook (including “checklists for good practice in E.C.T.”) produced by the Royal College of Psychiatrists (61).

2. There is guidance for nurses in the Royal College of Nursing’s E.C.T. Guidance for Nurses (137).

3. Guidance is also available in Electroconvulsive Therapy (E.C.T.). A Good Practice Statement and the accompanying summary for purchasers, produced by the Working Group on Mental Illness of the Clinical Resource and Audit Group at the Department of Health in The Scottish Office 26 27.

4. There are no accurate or accepted criteria to determine a person’s threshold for the current involved in E.C.T.

5. The post-treatment care and observation of outpatients, but especially inpatients, has generally been given insufficient consideration.

6. There is no national specification for E.C.T. machines.

5.6 Quality of care and practice of E.C.T.

1. There are extremely wide variations in the use of E.C.T. between psychiatrists, hospitals and regions, without any apparently logical reasons for this.

2. Audits by the Royal College of Psychiatrists showed that one-third of units examined failed to deliver adequate care in 1981, and 21% in 1995. Despite some improvements in practice, only 30% of E.C.T. clinics were rated as good or exemplary in 1995.

3. The anaesthetic standards of care and practice used for E.C.T. are substantially inferior to those for other patients (such as those receiving day surgery) and commonly fall short of accepted national guidelines.

4. Despite several initiatives and audits by the Royal College of Psychiatrists since 1980, E.C.T. is still often being delivered by inadequately trained staff.

5.7 Training and supervision of clinical staff.

1. The Royal College of Psychiatrists recommends that each individual E.C.T. service should have a named consultant responsible for its supervision and for ensuring that it meets the standards set.

2. E.C.T. clinics that are genuinely consultant-led tend to achieve higher standards than others, but are the exception in Britain.

3. In Britain, most E.C.T. is administered by junior doctors on rotation. Many have had little or no training in E.C.T. and often administer it without consultant supervision. The training that is given is of variable quality.

4. The traditional British system of delegating responsibility to junior staff for the administration of E.C.T. effectively prevents accreditation and the assurance of high quality training and supervision.

5. There are no training or competency standards for nurses practising in E.C.T. clinics.

5.8 Consent, information and explanations.

1. The rights of patients to give or withhold consent to E.C.T. are essentially the same as that for other patients. Patient do not have an absolute legal right to refuse E.C.T.

2. Particular care is required in regard to consent to treatment for patients under 16 years or adults with a learning disability.

3. Initial consent does not imply agreement to a course of E.C.T. and should be verified before each treatment.

4. There are particular considerations needed for consent in regard to patients detained under the Mental Health Act 1983, both generally for any treatment and specifically for E.C.T., as detailed in the Mental Health Act Code of Practice.

5. Depressive illness can influence a person’s perception of events and their ability to think, ask questions and concentrate.

6. There is anecdotal evidence that some patients consent to E.C.T. because of coercion or threat by clinical staff.

7. The validity of consent by many patients is questionable in terms of the quality and sufficiency of the information and explanations given, and their perception (real or otherwise) of whether they have a choice to accept or refuse E.C.T. or alternative treatments.

8. Sufficient information and explanations, including about any significant risks and alternative treatments, must be given to a patient (using languages and formats appropriate to their individual needs) before they can make an informed decision about whether or not to give consent.

9. The quality and depth of information and explanations for patients is often poor and sometimes non-existent. Nearly all information for patients about E.C.T. is that written by professionals and does not incorporate survivors’ views and experiences.

10. Many survivors report that they were never advised about any significant risks or alternative treatments before consenting to E.C.T.

11. Older people and women are less aware of their rights than younger people and men. This may be even worse for people with sensory impairments, people from black and ethnic minorities and people whose first language is not English.

12. Patients (whether or not detained under the Mental Health Act) have no legal right to be offered or to be given an independent second opinion where E.C.T. is considered as a treatment of choice.

13. Independent advocacy is rarely available or offered to patients before they are asked to consent to E.C.T. or indeed at any other time. This is especially so for older people.

14. Memory loss due to E.C.T. may affect the patient’s recollection of information given beforehand. It is advised that this should be repeated at an appropriate time soon after the treatment has been given, at the end of a course of treatment and when they are symptomatically improved.

15. About 2 000 people per year in England and Wales are given E.C.T. without or against their consent. Many are considered not able to give or withhold their consent. These are people who are seriously ill and treated under the Mental Health Act following an opinion given by a second opinion appointed doctor. More than half are women over 50 years old. Compulsory treatment is twice as common for people diagnosed with schizophrenia than for those diagnosed with depression.

5.9 The monitoring of E.C.T. and its administration.

1. The Royal College of Psychiatrists has a role to inspect the facilities available for the administration of E.C.T. and ask searching questions about the training of junior doctors administering the treatment. If serious shortcomings are detected and are not rectified, the Royal College can withdraw educational approval from the N.H.S. trust or other provider in question.

2. The Royal College of Psychiatrists stated in 1997 that failure to provide E.C.T. in accordance with its guidelines may result in the withdrawal of approved training status of the N.H.S. trust or other provider concerned.

3. The Mental Health Act Commission has a responsibility to ensure that patients detained under the Mental Health Act 1983 meets the standards within the Act and the Mental Health Act Code of Practice. The Commission is considering ways in which to ensure that the recommendations in The E.C.T. Handbook of the Royal College of Psychiatrists are adopted.

4. While there has been considerable work done in Scotland to audit the use and administration of E.C.T. in Scotland (by the Clinical Resource and Audit Group for the Scottish Office 26 27), there is no comparable work in England, Wales or Northern Ireland.

B.E.C.T. and Its Use in the Mental Health Services of Salford.

5.10 E.C.T. and its use in Salford.

1. The use of E.C.T. in Salford peaked in 1987 and had significantly declined since then, although this change was exacerbated by the reduction and eventual closure of the large Regional Long-Stay Service.

2. Part of the reduction in the use of E.C.T. was also due to depression being identified earlier and also the introduction and use of more effective drugs for depressive and manic conditions.

3. The Mental Health Services of Salford N.H.S. Trust was treating fewer patients with E.C.T. than other N.H.S. trusts in Greater Manchester for which information was made available. A relatively high proportion of these patients were, however, treated while detained under the Mental Health Act.

4. While fewer patients now receive E.C.T., those that do receive a similar number of treatments for a similar length of time as in previous years.

5. The figures provided by the Trust suggest a rate of 250-280 E.C.T. treatments per 100 000 population. This is in the mid-range for reported rates across England and Wales.

6. There were clear variations in the use of E.C.T. for individual consultants year-on-year, but also between consultants. There was no information held by the Trust to compare these rates with consultants in other N.H.S. trusts.

7. Consultants in the Trust claim to prescribe E.C.T. according to diagnosis and mainly for depression and rarely for conditions such as catatonic schizophrenia.

8 .Consultants in the Trust state that they use the presence of delusion and biological symptoms as the criteria to determine the likely effectiveness of E.C.T.

9. E.C.T. appears to be prescribed when depression is very severe, other treatments have previously produced negative results for individual patients, or for people who cannot tolerate antidepressants.

10. The vast majority of patients receiving E.C.T. in Salford are Salford residents.

11. An average of 69.6% of all E.C.T. patients in the Mental Health Services of Salford N.H.S. Trust were female and only 30.4% male. These proportions did not vary greatly for patients under 65 and those over 65. With the exception of one other N.H.S. trust, this difference was similar to other N.H.S. trusts in Greater Manchester for which information was made available.

12. The gender difference was reported as being due to more women experiencing depression and also living longer.

13. No detailed information about the age of E.C.T. patients was available. This was limited to whether patients were under 65 years or over 65 years.

14. There is no evidence of E.C.T. being given to anyone under 18 years of age in the recent past.

15. On average, 60.2% of all E.C.T. patients were over 65 years and 39.8% under 65. This age difference varied only slightly between male and female patients. With the exception of one other N.H.S. trust, this difference varied from other N.H.S. trusts in Greater Manchester for which information was made available, where a significantly higher proportion of patients getting E.C.T. were under 65.

16. The Trust reported that it did not record the ethnicity of patients receiving E.C.T., but a 1997 survey of N.H.S. trusts in Greater Manchester stated that 2.1% of patients receiving E.C.T. in the Trust were from an ethnic minority. This was a very low rate compared with other N.H.S. trusts in Greater Manchester (with one exception) where information was made available, and reflects the relative proportion of people from black and ethnic minorities within the Salford population.

5.11 Effectiveness of E.C.T. in Salford.

1. There has never been any research or clinical audit undertaken in Salford on the effectiveness of E.C.T. [It is intended during 1998/99 to undertake clinical audit of E.C.T. use in people under 65 years at Meadowbrook].

5.12 Risks and side-effects of E.C.T. in Salford.

1. There was no formal mechanism or process to assess the side-effects of E.C.T. on the patients who are given E.C.T.

2. There had been no deaths associated with E.C.T. in the recent past. There had been two or three deaths in previous years, but consultants reported that these patients would probably have died anyway.

5.13 E.C.T. and alternative treatments in Salford.

1. The only alternative treatments to E.C.T. mentioned by consultants were drugs (particularly antidepressants). There was no mention of psychological alternatives or “talking treatments”, although the Trust later commented that these are considered but most people prescribed E.C.T. are not amenable to these at the time.

5.14 Rules, guidance and criteria for E.C.T. in Salford.

1. The only guidelines available for E.C.T. are the E.C.T. guidelines for anaesthesia and the Trust’s procedure guidance for E.C.T. These were not referred to by the Trust until specifically asked about them by the C.H.C.

2. The anaesthetic guidelines for E.C.T. varied significantly from those used for day surgery in the Salford Royal Hospitals N.H.S. Trust. The difference did not appear to be completely due to the difference in treatments.

5.15 Quality of care and practice of E.C.T. in Salford.

3. It is very likely that some patients who are given E.C.T. would be refused day surgery in the acute hospital.

4. The E.C.T. machines in use at the time of the project were not the most up-to-date available, although a new one, capable of E.C.G. monitoring, E.E.G. traces and adjusting the voltage by age, was on order by the end of the project period.

5. The reserve E.C.T. machines available for use if the other machines fail are obsolete.

6. The Trust has its E.C.T. machines serviced on an annual basis. This is less than some other N.H.S. trusts in Greater Manchester, who have their machines serviced every six months.

7. The physical environment of the E.C.T. facilities within the Mental Health Services of Salford N.H.S. Trust improved as a result of the relocation of the E.C.T. Suite to Meadowbrook, although they were no less clinical. [The Trust is currently in discussion with the anaesthetic staff of Hope Hospital about potential alternative accommodation for the provision of E.C.T. services].

5.16 Training and supervision of clinical staff in Salford.

1. E.C.T. was administered in the Trust by junior doctors who had no specific or formal training in E.C.T. When offered training (which is not compulsory) in 1997, none of the trainee psychiatrists took it up.

2. All junior doctors on rotation were required from 1 August, 1997, to complete a log book defining the experience they had, as well as to develop a learning contract within the first month of their attachment with the Trust. These were intended to act as checks to ensure that doctors administering E.C.T. received the appropriate training.

3. The sessional time allocated to consultants is insufficient to allow adequate closer supervision of E.C.T. services.

4. There was no evidence shown that any nursing staff received or were required to have any specific training in E.C.T.

5.17 Consent, information and explanations in Salford.

1. The Trust has a written procedure for consent to treatment and a quality statement on consent to treatment under the Mental Health Act. Neither of these was referred to in discussions with the Trust until specifically raised by the Project Team.

2. There is a consent form specific to E.C.T., although this is relatively old and contains some complex language.

3. Consent is sought from patients before each individual treatment. The capacity to give or withhold consent is, however, only sought at the start of a course of treatment.

4. Consent issues are included in Mental Health Act training for Trust staff.

5. The Trust does not provide written information about E.C.T. to each patient offered it. This is probably mainly given only on request.

6. The only written information available for patients was the Royal College of Psychiatrists’ fact sheet. Information on E.C.T. is not available in any other formats or languages.

7. Most information and explanation is given verbally, initially by the doctor prescribing it, with this being backed up by nursing staff and E.C.T. staff before the patient’s first treatment.

8. While an independent advocacy service had been established by the Salford Mental Health Citizen’s Advice Bureau at Meadowbrook in 1997, this was limited to patients under 65 and there appeared to be significantly limited patients awareness of it. It was not automatically offered to each patient offered E.C.T.

5.18 The monitoring of E.C.T. and its administration in Salford.

1. The Trust found it difficult to find some basic information about the use of E.C.T. This was partly due to the organisation of services in past years.

2. The information the Trust was able to provide about the use of E.C.T. was relatively crude. This was mainly because all such information was and continued to be recorded in written records, and also because some information about patients was not collected at all.

3. The monitoring and auditing of E.C.T. would be extremely difficult due to the methods used to record information.

4. Only one clinical audit had ever been undertaken on E.C.T. in the mental health services in Salford. This was in 1992 and only about an aspect of E.C.T. administration rather than outcomes.

5. There was no evidence of any research having ever been done on E.C.T. in the mental health services in Salford.

6. The Trust had no formal mechanisms in place to monitor the long-term effectiveness or the side-effects of E.C.T. on patients.

7. No previous work had ever been done in Salford to obtain patients’ or survivors’ views on E.C.T.

6. Recommendations.

6.1 Use of E.C.T.

1. E.C.T. should be used:

-only when the objective is to achieve rapid and short-term beneficial effects (for at most eight weeks)

-to treat the symptoms of only limited categories of delusional and severe endogenous depressive illness where the patient:

-has a high number of typical features of depressive illness, but only when these include psychotic features and psychomotor disturbance, and

-exhibits symptoms of retardation and/or depressive delusions or

-is in a critical state through no longer eating or drinking, but only as a last resort when no other effective treatment is available that has not already been tried.

-to treat only limited categories of certain manic syndromes, but not as a first-line treatment unless the illness is genuinely life-threatening.

-to treat only limited categories of Type I (acute) schizophrenia in patients with specific indicators.

-to treat people with affective and catatonic disorders only when account has been taken of specific medical risks and appropriate modifications made.

2. Extreme caution should be used and all other alternatives attempted before considering E.C.T. where patients have any of the following: angina; congestive heart failure; severe pulmonary disease; severe osteoporosis; major bone fractures; glaucoma; retinal detachment; thrombophlebitis; and pregnancy (especially in the first trimester).

3. E.C.T. should not be used:

-where the objective is to achieve a long-term beneficial effect or to influence long-term survival

-to treat Type II (chronic) schizophrenia

-to treat either Parkinson’s Disease or epilepsy

-to treat violent or offending behaviour, obsessive-compulsive disorders, anxiety, post-traumatic stress disorder, stroke, dementing illnesses, cardiovascular disease or diabetes.

-to try to prevent suicide.

-to treat patients who have had a recent myocardial infarction (heart attack), a recent cerebrovascular accident (stroke) or an intracranial mass or lesion (brain injury or tumour).

4. The Government should ban E.C.T. for children and young people under 18 years.

5. More careful consideration and guidance is required for the clinically effective use of E.C.T. for patients who are taking psychotropic and other drugs. The use of an increased number of E.C.T. treatments for patients taking psychotropic and other drugs should be avoided.

6.2 Administration of E.C.T.

1. E.C.T. should be used only in accordance with the guidance and recommendations within the Royal College of Psychiatrists’ E.C.T. Handbook.

2. The choice of unilateral or bilateral E.C.T. should be made using the guidance and criteria within the Royal College of Psychiatrists’ E.C.T. Handbook.

3. Only brief-pulse E.C.T. should be used. The Department of Health should ban sine-wave E.C.T.

4. E.C.T. should not be given to patients more than an absolute maximum of twice per week.

5. Where possible, E.C.T. should be given to patients where this is voluntary, with the patient’s informed consent after a full explanation of the treatment, its risks and alternatives, where it is not used (or is perceived as being used) as a threat.

6. Patients who are given “maintenance” or “continuation” E.C.T. should have their memory and cognitive function recorded on a monthly basis.

7. Non-drug (“talking”) therapies as well as drug treatments should always be considered as possible alternatives to E.C.T. before it is suggested or prescribed.

8. All nurses involved in dealing with E.C.T. patients should use the measures identified in the Royal College of Nursing’s E.C.T. – Guidance for Nurses {(137) to reduce the anxiety of patients before E.C.T. and the level of memory impairment afterwards.

6.3 Training and supervision of clinical staff.

1. Each individual E.C.T. clinic should:

-be genuinely consultant-led, with adequate sessional time allocated to consultants to supervise E.C.T. services

-have a named consultant with clinical and administrative responsibility for its supervision and for ensuring that it meets the standards set

-have a programme of initial and continued training for clinical staff in E.C.T. techniques.

2. No doctor should be allowed to administer E.C.T. unless they have had approved training and either are a consultant or have direct supervision of a consultant.

3. The Department of Health and the Royal College of Psychiatrists should establish a mandatory national accreditation scheme for doctors prescribing or administering E.C.T., with complementary accredited training courses.

4. The Department of Health, in consultation with appropriate nursing and user / survivor organisations, should establish at the earliest opportunity national training and competency standards for nursing practising in E.C.T. clinics. These should be developed from the guidance in the Royal College of Psychiatrists’ E.C.T. Handbook (61) and the Royal College of Nursing’s E.C.T. – Guidance for Nurses (137).

6.4 Rules, guidance and criteria for E.C.T.

1. E.C.T. should be given according to the good practice guidelines set out by the Royal College of Psychiatrists in The E.C.T. Handbook (61), and the accompanying Checklists for Good Practice in E.C.T. 139.

2. The United Kingdom Central Council for Nursing, Midwifery and Health Visiting, in consultation with user / survivor organisations, should develop national guidance for all nurses involved in E.C.T. developed from that in:

-the Royal College of Psychiatrists’ E.C.T. Handbook (61)

-the Royal College of Nursing’s E.C.T. – Guidance for Nurses (137) and

-Electroconvulsive Therapy (E.C.T.). A Good Practice Statement by the Working Group on Mental Illness of the Clinical Resource and Audit Group at the Department of Health in The Scottish Office 26.

3. All health authorities and other commissioning organisations should specify in their contracts or service level agreements for mental health services that:

-E.C.T. should be only be administered in accordance with the most recent guidelines of the Royal College of Psychiatrists, and

-as a minimum, E.C.T. should be undertaken to the same quality standards as apply to surgical procedures that are carried out under general anaesthetic in the nearest district general hospital.
4. The Department of Health, in consultation with appropriate professional and user / survivor organisations, should develop clear national guidance about the post-treatment care and observation of both outpatients and inpatients.

5. The Department of Health should set a national specification for E.C.T. machines, including standards for their maintenance and replacement.

6. All E.C.T. machines should be serviced at least every six months and be replaced after no more than five years.

6.5 Quality of care and practice of E.C.T.

1. Those E.C.T. clinics that fail to provide at least adequate care and treatment should be closed.

2. The Department of Health, together with the Royal College of Anaesthetists, should take action to raise the anaesthetic standards of care and practice for E.C.T. and the criteria used for E.C.T. to at least the same exacting level as is required for day surgery under general anaesthetic.

6.6 Consent, information and explanations.

1. The Department of Health, in consultation with appropriate professional and user / survivor organisations, should institute and develop statutory nationally agreed, evidence-based information on E.C.T., including about all significant risks and alternatives. This should be available and provided in a format and language appropriate to each patient where E.C.T. is being considered. It should include answers to the questions suggested by Mind and give equal weight to the views of both survivors and professionals.

2. Sufficient information and explanations, including about any significant risks and alternative treatments, should be given to a patient (using languages and formats appropriate to their individual needs) before they can make an informed decision about whether or not to give consent.

3. Information given to a patient before E.C.T. should always be repeated at an appropriate time soon after the treatment has been given, at the end of a course of treatment and when they are symptomatically improved.

4. Specific written information (or in another format appropriate to the patient) should be given to people receiving outpatient E.C.T. after their treatment about the precautions they should take for their own safety and well-being.

5. A patient’s consent and their capacity to consent should be verified before each individual E.C.T. treatment, and not only at the start of a course of treatment.

6. Patient consent to E.C.T. should never be obtained by coercion or threat by clinical staff or others. Mechanisms to monitor and prevent this should be developed and implemented.

7. The Government should legislate so that E.C.T. cannot be administered without a patient’s informed consent unless it is considered the only remaining way available to save their life.

8. The Government should legislate to give all patients (whether or not detained under the Mental Health Act) the legal right to be offered and to be given an independent second opinion where E.C.T. is considered as a treatment of choice.

9. Independent advocacy should always be available and explicitly offered to patients before they are asked to consent to E.C.T., and then both during and after a course of E.C.T.

6.7 The monitoring of E.C.T. and its administration.

1. Each E.C.T. clinic should routinely audit its standards of practice, use, indications for and outcomes of E.C.T.

2. The Department of Health should require all N.H.S. trusts and other providers to record and publicly report on the use of E.C.T., including the diagnosis, gender, age and ethnicity of patients. The Department of Health should collect and collate this information and publish a regular breakdown of all E.C.T. treatments by N.H.S. trust throughout the U.K., with an assessment of outcome.

3. The Department of Health should establish a national audit in England of electro-convulsive therapy. The remit of this audit should include: E.C.T. and its use; the effectiveness of E.C.T.; the risks and side-effects of E.C.T.; alternative treatments to E.C.T.; rules, guidance and criteria for E.C.T.; quality of care and practice of E.C.T.; training and supervision of clinical staff; consent, information and explanations; and the monitoring of E.C.T. and its administration. This audit should take full consideration of patients’ and survivors’ views, and have full patients and survivor involvement in the groups that undertake the audits.

4. The Royal College of Psychiatrists should immediately withdraw approved training status from every N.H.S. trust or other provider in question where they are not providing E.C.T. in accordance with its current guidelines.

5. The Mental Health Act Commission should incorporate the guidelines from The E.C.T. Handbook (61) of the Royal College of Psychiatrists and the Royal College of Nursing’s E.C.T. – Guidance for Nurses (137) into its monitoring of services provided to patients detained under the Mental Health Act.

6.8 Research.

1. The Department of Health should actively encourage the development of a high-quality E.C.T. research programme, similar to that already established in Scotland. This should focus on:

-establishing the basic mechanisms through which E.C.T. operates

-the reasons why women and older people are more likely to be given E.C.T., and how far these patterns are based on clinical grounds

-the reasons for the extremely wide variations in the use of E.C.T. between psychiatrists, hospitals and regions

-the reasons why many more people are given E.C.T. in the United Kingdom than in other countries in Europe, some parts of North America and the Far East

-the long-term effectiveness and side-effects of E.C.T. with regard to the quality of life or social functioning of survivors

-the relative effectiveness of E.C.T. and alternative treatments

-the effectiveness of “continuation” or “maintenance” E.C.T.

-establishing the criteria to determine each individual’s threshold for the current involved in E.C.T.

-the effects of psychotropic and anaesthetic drugs on the efficacy and safety of E.C.T. and their interactions

-survivors’ views on E.C.T.

-the level of coercion or threat in practice by clinical staff to obtain patient consent and to what extent coercions and threats are intended or perceived.

B.E.C.T. and its Use in the Mental Health Services of Salford.

6.9 Strategy for change in Salford.

1. The Trust should develop a strategy for change in the use and administration of E.C.T. This initiative should include the consultant psychiatrist responsible for the treatment service, survivors (with their representatives), a named manager and key nurses involved in the treatment process. This strategy should address each of the elements below.

6.10 Use of E.C.T. in Salford.

1. Consultant psychiatrists in the Trust should use the criteria identified in section 6.1 for prescribing E.C.T.

2. Medical staff in the Trust should give much greater consideration to non-drug (“talking”) therapies (as well as drug treatments) as alternatives to E.C.T. before it is suggested or prescribed.

6.11 Training and supervision of clinical staff in Salford.

1. The Trust should ensure that its E.C.T. service is genuinely consultant-led by a named consultant with clinical and administrative responsibility for its supervision and for ensuring that it meets the standards set. [E.C.T. is now overviewed by the Trust's Drugs and Therapeutics Committee chaired by the Medical Director and reports to the Trust Board].

2. The Trust should allocate more sessional time to consultants to allow closer supervision of E.C.T. services. [The Trust altered its arrangements in 1997 to ensure that at least one consultant is in the building when E.C.T. is being administered and available to attend the E.C.T. suite].

3. The Trust should not permit any doctor to administer E.C.T. unless they either are a consultant or have direct supervision of a consultant, and have had approved training, and have demonstrated that they have achieved the appropriate level of competence.

4. The Trust should develop a programme of initial and continued training for clinical staff in E.C.T. techniques.

5. The Trust should require all nursing staff working in the E.C.T. clinic to have undergone appropriate approved E.C.T. training and demonstrated that they have achieved the appropriate level of competence.

6.12 Rules, guidance and criteria for E.C.T. in Salford.

1. The Trust should review and revise its guidance on E.C.T. to ensure that it accords with and incorporates all of the recommendations of The E.C.T. Handbook (61) of the Royal College of Psychiatrists, the Royal College of Nursing’s E.C.T. – Guidance for Nurses (137) and Electroconvulsive Therapy (E.C.T.). A Good Practice Statement by the Working Group on Mental Illness of the Clinical Resource and Audit Group at the Department of Health in The Scottish Office 26.

2. Clinical staff prescribing and administering E.C.T. within the Trust should develop a clinical protocol for the use and administration of E.C.T. that incorporates each of the items in sections 6.1-6.4 above

3. The Trust, together with consultant anaesthetic staff from the Salford Royal Hospitals N.H.S. trust, should rewrite the anaesthetic guidelines for E.C.T. so that the criteria and standards of care are at least as high and exacting as those for day surgery under general anaesthetic in the Salford Royal Hospitals N.H.S. Trust. These should also take into account issues raised in section 6.1 above.

4. Salford and Trafford Health Authority and other commissioning organisations in Salford should specify in their contracts or service level agreements for mental health services that:

-E.C.T. should be only be administered in accordance with the most recent guidelines of the Royal College of Psychiatrists, and

-as a minimum, E.C.T. should be undertaken to the same quality standards as apply to surgical procedures that are carried out under general anaesthetic in the Salford Royal Hospitals N.H.S. Trust.

6.13 Quality of care and practice of E.C.T. in Salford.

1. The Trust should not allow any patient to be given E.C.T. who would be refused day surgery under the anaesthetic criteria for day surgery in the Salford Royal Hospitals N.H.S. Trust, unless it is the only remaining option likely to save their life.

2. The Trust should use only E.C.T. machines (including reserve machines) that meet the current national specification. All available machines should be capable of E.C.G. monitoring and E.E.G. traces.

3. The Trust should ensure that all its E.C.T. machines are serviced at least every six months and replaced after no more than five years.

6.14 Consent, information and explanations in Salford.

1. The Trust, in consultation with professionals and survivors, should develop a new source of evidence-based patient information on E.C.T., including about all significant risks and alternatives, to replace the Royal College of Psychiatrists’ fact sheet. This should include answers to the questions suggested by Mind and give equal weight to the views of both survivors and professionals.

2. Clinical staff should automatically provide information on E.C.T. to each patient in a format and language appropriate to them where E.C.T. is being considered, to complement the verbal explanation and discussion with clinical staff, before the patient is asked to make an informed decision about whether or not to give consent.

3. Clinical staff should always repeat information given to a patient before E.C.T. at an appropriate time soon after the treatment has been given, at the end of a course of treatment and when they are symptomatically improved.

4. Clinical staff should give every outpatient specific written information (or in another format appropriate to the patient) after their treatment about the precautions they should take for their own safety and well-being.

5. Clinical staff should verify the capacity of each patient to give or withhold consent (as well as their consent itself) before each individual treatment, and not only at the start of a course of treatment.

6. The Trust should completely revise its consent form for E.C.T. to ensure that it can be fully understood by patients and addresses each criterion required to ensure informed consent. The model developed by the Salford Royal Hospitals N.H.S. Trust for surgery should be used within this process.

7. Where a patient’s informed consent is in doubt, clinical staff should delay giving E.C.T. while advocacy, second opinions and alternative treatments are explored, unless E.C.T. is considered immediately necessary as the only life-saving treatment available.

8. The Trust, together with the Salford Mental Health Services Citizen’s Advice Bureau, should ensure that independent advocacy is always available and explicitly offered to every patient before they are asked to consent to E.C.T., and then both during and after a course of E.C.T.

6.15 The monitoring of E.C.T. and its administration in Salford.

1. The Trust should record and regularly report in public on the use of E.C.T., including the diagnosis, gender, age and ethnicity of patients.

2. The Trust should establish formal mechanisms to assess and monitor the short-term and long-term side-effects of E.C.T. on patients.

3. The Trust should establish a programme of regular clinical audit for E.C.T., focusing on its administration, indications, side-effects, short-term and long-term effectiveness with particular regard to the quality of life and social functioning of survivors.

6.16 Research in Salford.

1. The Trust should urgently develop processes and mechanisms (including the use of information technology) to enable it to monitor the E.C.T. service and easily produce information about its use, the patients who receive it, and its effectiveness.

2. The Trust should hold regular reviews of E.C.T. to ensure that E.C.T. is only administered in accordance with the most recent guidelines of the Royal College of Psychiatrists.

3. The Trust should audit the use of E.C.T. and identify the appropriateness of its use and whether other more effective alternatives could have been used instead.

4. The Trust should investigate the reasons why:

-such a relatively high proportion of patients given E.C.T. within the Trust are detained under the Mental Health Act

-there are such wide variations in the use of E.C.T. for individual consultants year-on-year and between consultants.

-a significantly higher proportion of patients receiving E.C.T. are over 65 in the Trust than in other local N.H.S. trusts

Any variations that cannot be justified on clinical grounds should be addressed through appropriate action.

5. The Trust, together with the University of Manchester, should encourage high-quality research on the administration, use, effectiveness and survivors’ views of E.C.T. the Trust, focusing on the issues in 6.8 above.

Appendices.

Appendix One.

Salford Health Authority Mental Health Unit – E.C.T. Guidelines for the preparation and care of patients undergoing E.C.T.

1)Prior to the prescription and commencement of E.C.T. the following must be undertaken as indicated:

a)HB-all patients

sickle cell test if indicated

U & Es-if on lithium / diuretics / I.V.I.s

Urine-routine urinalysis including glucose

E.C.G.-men over 40 years of age
-women over 45 years of age

-also any patient who is hypertensive or has a history of heart disease

C.X.R.-only if chest symptoms or previous history of respiratory disease.

b)A full physical examination must be undertaken unless one has been recorded in the preceding 4 weeks.

2)When attending for treatment

a)Signed consent form pinned to front cover of notes and current medication sheets must accompany patient.

b)Identity bracelets must be worn.

c)Nurses who do escort duty to E.C.T. must know patient.

d)Wards sending more than 3 patients are required to send a minimum of 2 staff.

3)Out-Patients who live alone should be kept in hospital overnight following treatment. If a responsible person is at home then the patient may go home after lunch.

If these guidelines are not adhered to, E.C.T. will not be given.

January 1990.

Mental Health Services of Salford N.H.S. Trust – E.C.T. Guidelines.

1) PRIOR TO COMMENCING E.C.T.:

a) A full physical examination must be undertaken, and the findings recorded on the E.C.T. chart.
b) The following investigations must be performed, as appropriate, and the results clearly visible in the patient’s notes.
FBC: All patients
Sickle Test: If indicated on the basis of ethnic origin
U & EIf on diuretics, Lithium, I.V.I.s, Potassium supplements
Glucose: All diabetics
Urinalysis: All patients
E.C.G.: All patients over 45 years of age; Any patient who is hypertensive, diabetic or has a history of heart disease
C.X.R.: Only if history of respiratory disease, or on-going chest symptoms

2) WHEN ATTENDING FOR TREATMENT:

a) A signed consent form, or up-to-date Section form, should be in the front of the patient’s notes.
b) The current medication sheet must accompany the patient.
c) Identity bracelets should be worn by all patients.
d) Nurses escorting patients to E.C.T. should ideally know them, or at the very least, have been given some background information about the patient’s condition or any recent changes in condition, treatment, or pre-medication that is relevant to the anaesthetic and E.C.T.
e) Wards sending more than 3 patients are required to send a minimum of 2 staff.

3) OUT-PATIENTS:

Current anaesthetic recommendations stress the importance of adequate supervision of any patient having any anaesthetic on a day-case basis, however minor the procedure.

Those patients who DO NOT LIVE ALONE require a responsible adult to accompany them home, after lunch, and subsequently take responsibility for them at home.
Those patients WHO DO LIVE ALONE should be kept in hospital overnight following treatment.

4) INTER-HOSPITAL TRANSFERS:

Patients transferred between Hope and Prestwich for E.C.T. must be accompanied by at least one qualified member of staff.
In the interest of patient safety, if these guidelines are not adhered to, then E.C.T. will not be given.
November 1996.

Salford Royal Hospitals N.H.S. Trust.
Criteria for Day Surgery.

Guidelines for Referral of Patients Requiring General or Regional Anaesthesia.

NON-MEDICAL FACTORS.
1. Distance between Hospital and home no more than 60 minutes travelling time.
2. Access to transportation. Public transport should not be used.
3. Patients should have telephone communication with the Hospital.
4. No patient should be alone at night after the operation.

MEDICAL FACTORS.
1. Age. No patient over 75 years.
2. Length of operation. Surgical procedures should be capable of completion within 90 minutes of start of general anaesthetic, but this is not a hard and fast rule.
3. Physical status. All patients should be A.S.A. Grades I or II – rarely III.
A.S.A. I-A normal healthy patient.
A.S.A. II-A patient with mild to moderate systemic disease caused by the condition to be treated surgically or by any other disease.
A.S.A. III-Severe systemic disease or disturbance from any cause.
Patients with Grade III who might be considered suitable for day surgery anaesthesia are those with chronic arthritic disease or chronic haemolytic disease.
Occasionally some apparently Grade I patients are not suitable – e.g. those with: -
1. Sickle cell disease.
2. Malignant hyperpyrexia.
3. Porphyria.

MORE DETAILED CONTRA-INDICATIONS TO DAY SURGERY ANAESTHESIA.
CARDIOVASCULAR DISEASE.
1. Myocardial infarction within the preceding six months.
2. Hypertension. B.P. above 175/100 mm Hg.
Resting pulse rates below 50/mm and above 100/mm require further investigation.
3. Cerebro-vascular insufficiency.
4. Cardiac failure.
5. Heart block other than type I.

RESPIRATORY DISEASE.
1. Severe bronchitis and emphysema.
2. Severe asthma.
3. Severe bronchiectasis.
4. Acute respiratory infections.

MUSCULO-SKELETAL CONDITIONS.
1. Conditions causing reduction in vital capacity, e.g. kyphoscoliosis.
2. Conditions making endotracheal intubation difficult, e.g.:
a)ankylosis of temporal mandibular joints.
b)Congenital defects of head, neck and jaws.
c)Ankylosing spondylitis.

NERVOUS SYSTEM.
1. Motor neurone disease.
2. Muscular dystrophies and myotonic disorders.
3. Severe epilepsy.

HAEMATOLOGY.
1. Coagulation defects.
2. Severe haemolytic anaemias.
3. Anti-coagulant therapy.

ENDOCRINE.
1. Unstable diabetics on insulin or oral hypoglycaemic agents.
2. Obesity, i.e. greater that 20% above ideal weight for age and sex.

PREGNANCY.

Appendix Two.

Salford Health Authority Mental Health Unit.
Procedure Guidance Notes on the Mental Health Act 1983. Subject:Consent to Treatment.
Code:PGN CONS
Date Published:December 1992.
Review Date:December 1994.
This guidance has been prepared as reference information for staff within the Mental Health Unit.

Introduction.

1. Detailed information has been prepared on this subject in the “Quality statements, guidelines and procedure folder” under “Consent to treatment [Mental Health Act 1983]“.

2. To aid staff identify the correct procedure, flow charts and appropriate forms have been attached: -

Consent to treatment after the first 3 months – flow chart attached – Appendix 1.

Consent to treatment at review of treatment – flow chart attached – Appendix 2.

Certificate of consent to treatment – Form 38 [when patient consents].

Certificate of second opinion – Form 39 [when patient does not consent].

Annex AMHAC 1 form
[completed by R.M.O., when appropriate, on renewal of section and forwarded to Mental Health Act Commission].

Section 62 – urgent treatment
[when patient urgently requires medication or E.C.T.].

Mental Health Services of Salford. An N.H.S. Trust.

Procedure.
Subject:Consent to Treatment.
Code:PGN.CONS
Date Published:March 1995.
Review Date:October 1999.
This guidance has been prepared as reference information for staff within the Mental Health Unit.
Introduction.

1. Detailed information has been prepared on this subject in the “Quality Statements, Guidelines and Procedure Folder” under “Consent to treatment (Mental Health Act 1983)”.

2. To aid staff identify the correct procedure, flow charts and appropriate forms have been attached: -

Consent to treatment after the first 3 months – flow chart attached – Appendix 1.

Consent to treatment at review of treatment – flow chart attached – Appendix 2.

Certificate of consent to treatment – Form 38 [when patient consents].

Certificate of second opinion – Form 39 [when patient does not consent].

Annex AMHAC 1 form (completed by R.M.O., when appropriate, on renewal of section and forwarded to Mental Health Act Commission).

Section 62 – urgent treatment (when patient urgently requires medication or E.C.T.).

Appendix Three.

PRESTWICH / HOPE HOSPITAL, MANCHESTER.

E.C.T. Consent (Patient).

I ………………………………………………………………… hereby consent to undergo the administration of E.C.T., the nature and effect of which have been explained to me by Dr. ……………………………………………………………..

I also consent to the administration of an anaesthetic for this purpose.
No assurance has been given to me that the treatment will be administered by any particular practitioner.

(Date) ……………………………..(Signed) ………………………………………………….
(Patient)
____________________________
I confirm that I have explained to the patient the nature and effect of this treatment.

(Date) ……………………………..(Signed) ………………………………………………….
(Medical Officer)

Date
Treatment No and Type
Brietal Sodium
Atropine
Anectine
Comments include duration of fit, Cuff method if used, etc.
Initials of both doctors

……………………………………. HOSPITAL UNIT No. ___________________

FULL NAME (BLOCK LETTERS)
Mr. / Mrs. / Miss
____________________________

WARD OR ADDRESS

_____________________________________________________
(A)ESSENTIAL FACTS:-
(1)DATE OF BIRTH:……………………………………………

(2)LEGAL STATUS…………………
IF SECTION HAS FORM 38 BEEN COMPLETED. YES/NO
HAS FORM 39 BEEN COMPLETED. YES/NO

(3)ANY ALLERGIES, OR PREVIOUS DRUG/ECT ADVERSE REACTIONS (SPECIFY)
……………………………………………………………………………………………

(4)PRIMARY DIAGNOSIS……………………………………………….
SECONDARY DIAGNOSIS ……………………………………………….

(B)ESSENTIAL PHYSICAL FACTS:-
(1)IS PATIENT RIGHT OR LEFT HANDED ……………………………….
IS PATIENT RIGHT OR LEFT FOOTED ………………………………..

IS IT ESSENTIAL FOR PATIENT TO HAVE BILATERAL ECT?…….
(NEW POLICY: UNILATERAL UNLESS REQUESTED OTHERWISE).

(2)CVS:BP
OTHER ABNORMALITIES………………………………………
RS:STATE ABNORMALITIES………………………………………
SPINE: STATE ABNORMALITIES………………………………………

(3)WEIGHT (in Kg)………………………………………..
RECENT HAEMOGLOBIN LEVEL ……………………………………….
RECENT ELECTROLITE LEVELS (if abnormal) ……………………..

(4)E.C.G. RESULT ……………………………………………………………………

(5)CURRENT MEDICATION (DAY PATIENT. OUTPATIENT ONLY).
……………………………………………………………………………………………
……………………………………………………………………………………………

SIGNATURE …………………………………….DATE ……………………………………..

Appendix Four.

Salford Health Authority Mental Health Unit.
Procedure Guidance Notes on the Mental Health Act 1983.
Subject:Electro Convulsive Therapy
Code:PGN ECT
Date Published:December 1992.
Review Date:December 1994.
This guidance has been prepared as reference information for staff within the Mental Health Unit.

Informal Patients

1. Informal patients who consent to E.C.T. sign the local
consent to Electrotherapy / Anaesthetic form.

Detained Patients

2. If the patient is Compulsorily detained (other than a short term detention, i.e. Sections 4, 5(2), 5(4), 136) under the Mental Health Act 1983, a current copy of one of the following forms must be present and should be seen by the Doctor before E.C.T. commences.

FORM 38-Consent to treatment

FORM 39-Certificate of Second Opinion

Section 62-Urgent Treatment.

3. Consent to treatment regulations do not apply to short-term sections and such patients should be treated as for informal patients, i.e. can only have E.C.T. if valid consent is given and they sign the appropriate form as above (1).

4. Flow chart attached – Appendix 1.

Mental Health Services of Salford. An N.H.S. Trust.

Procedure.

Subject:Electro Convulsive Therapy (E.C.T.)
Code:PGN.ECT
Date Published:July 1996.
Review Date:July 2000.
guidance has been prepared as reference information for staff within the Mental Health Unit.
Informal Patients

1. Informal patients who consent to E.C.T. sign the local consent to Electrotherapy / Anaesthetic form.

Detained Patients

2. If the patient is compulsorily detained (other than a short term detention, i.e. Sections 4, 5(2), 5(4), 136) under the Mental Health Act 1983, a current copy of one of the following forms must be present and should be seen by the Doctor before E.C.T. commences.

FORM 38-Consent to treatment

FORM 39-Certificate of Second Opinion

Section 62-Urgent Treatment.

3. Consent to treatment regulations do not apply to short-term sections and such patients should be treated as for informal patients, i.e. can only have E.C.T. if valid consent is given and they sign the appropriate form as above (1).

4. Flow chart attached – Appendix 1.

Appendix Five.

Mental Health Services of Salford – Quality Statement.
Subject:Consent to Treatment (Mental Health Act 1983)
Code:CTT.QST
Date Published:February 1994
Review Date:February 1999
Which deals with consent to treatment. The majority of the information arises directly from the M.H.A. Code of Practice.

1. Part IV of the Act provides specific statutory authority for forms of medical treatment for mental disorder to be given to most patients liable to be detained without their consent in certain circumstances and with certain safeguards. It also provides specific safeguards. Patients liable to be detained are those who are detained or have been granted leave of absence (Section 17). It also provides specific safeguards to all patients when treatments are proposed that give rise to special concern.

2. Its provisions can be summarised as follows:
a)Treatments requiring the Patient’s Consent and a Second Opinion (Section 57) Psycho-surgery and the surgical implantation of hormones for the suppression of male sexual drive (exceptionally these safeguards apply to all patients).
b)Treatments requiring the Patient’s Consent or a Second Opinion (Section 58) The administration of medicine beyond three months, and treatment by E.C.T. at any time. These safeguards apply to all patients liable to be detained except those detained under S4, S5 (2) or (4), S35, S135, S136 and S37 (4); also patients conditionally discharged under S42 (2) and S73 and S74. All these patients can only be treated under common law.
c)Treatments that do not require the Patient’s Consent (Section 63) All medical treatments for mental disorder given by or under the direction of the patient’s responsible medical officer and which are not referred to in Section 57 or 58 (this provision applies to the same patients as S58).
d)Urgent Treatment (Section 62) In certain circumstances the provisions of Section 57 and 58 do not apply where urgent treatment is required.
3. Detained status itself does not imply inability to give consent. For all treatments proposed for a detained patient and which may be lawfully given under the Act, it is necessary first to seek the patient’s agreement. It is the personal responsibility of the patient’s R.M.O. to ensure that the patient’s valid consent has been sought and the interview at which such consent was sought should be properly recorded.

Validity of Consent.

4. The responsible medical officer must determine whether the patient is willing to take the medication and whether his consent is valid, i.e. whether he is “capable of understanding the nature, purpose and likely effects of the treatment.”

5. If the patients consents validly, the responsible medical officer records this on form 38.

6. If he refuses, or there is doubt about the validity of his/her consent, then a second opinion must be obtained from a doctor appointed for that purpose by the Mental Health Act Commission.

7. Electro Convulsive Therapy always requires either the patient’s consent or a second opinion, even where the treatment is given in the first 12 weeks of detention.

Renewal of Consent.

8. The patient’s consent, certified on form 38, does not expire. No formal renewals or review are required, but the patient’s consent should be reviewed from time to time. Good practice would be for form 38 to be completed at the renewal of each section.

9. The patient is free to withdraw his consent at any time.

10. In the case of patients subject to a form 39, formal reviews of treatment are required. These are recorded on the Mental Health Act Commission’s form “Review of Treatment”, (Section 61 Mental Health Act).

11. For unrestricted patients, these reviews should occur at each section renewal.

12. For restricted patients, they should occur at the end of the first six months of the order if the treatment under the form 39 began before that time, and then on each occasion when a statutory report to the Secretary of Statefalls due.

Treatments Requiring Consent or a Second Opinion (Section 58).

13. Treatments requiring patient’s informed consent or a second opinion currently specified by the Act are E.C.T. treatment and drug treatment of more than three months duration. This applies to patients detained under Sections 2 and 3 and by Court Treatment Orders.
14. Where the patient consents, the responsible medical officer or a medical practitioner appointed by the Commission (Second Opinion Appointed Doctor) will certify that informed consent has been given (form 38).
15. Where the patient does not consent, a second opinion appointed doctor will be requested by the responsible medical officer via Medical Records. On arrival the S.O.A.D. will consult with the R.M.O. and two persons professionally concerned with the patient, one a nurse and the other neither a doctor or a nurse and complete form 38 (if the patient now consents) or a form 39.
16. Once signed, forms 38 and 39 are lodged with other papers relating to the patient’s compulsory detention, in the Medical Records Office. Two photocopies must be made, one to be kept with the patient’s prescription sheet and the other to be retained with the photocopied section papers.

Medication Before Three Months.

17. This period starts on the occasion when medication for mental disorder was first administered by any means. The patient’s responsible medical officer must ensure that the patient’s valid consent is sought prior to the administration of any medication. If such consent is not forthcoming or is withdrawn during this period, the responsible medical officer must consider if he wishes to proceed in the absence of consent, consider alternative treatments or give no further treatment.

Medication After Three Months (Section 58).

18. At the end of the three month period referred to above, the patient’s responsible medical officer should personally seek the patient’s consent to continuing medication and such consent should be sought for any subsequent administration of medication. If the patient consents the responsible medical officer must certify accordingly (form 38). The responsible medical officer should indicate on the certificate the drugs proposed, by the classes described in the British National Formulary (indicating the dosages if they are above the B.N.F. advisory maximum limits) and the method of their administration. If the patient’s consent is not forthcoming the responsible medical officer must comply with the safeguard requirements of Section 58 (although for urgent treatment Section 62 may apply).

The Three Month Rule.

19. The three month period gives time for the doctor to create a treatmen programme suitable for the patient’s need. Although the patient can be treated in the absence of consent during this period, no such treatment should be given in the absence of an attempt to obtain valid consent. The three month period is not affected by renewal of the detention order, withdrawal of consent, leave or change in or discontinuance of the treatment. A fresh period will only begin if there is a break in the patient’s liability for detention.

20. If medication is likely to be continued beyond the three month period the need for consent or a second opinion should be foreseen in good time. Theresponsible medical officer should satisfy himself at all times that the consent remains valid.

Responsibility for Checking.

21. The Medical Records Department will remind the responsible medical officer to review consent when renewing sections and provide review of treatment forms at the appropriate times for patients subject to second opinions.

22. The responsible medical officer and medical staff will check the twelve week date on the prescription sheet and any existing forms 38 and 39.

Administering Drugs.

23. It is the responsibility of the doctor or nurse to check the prescription sheet and any attached documentation to ensure they have authority to administer the treatment.

Withdrawal of Consent.

24. The patient subject to the provisions of Part IV of the Act may withdraw consent at any time. Fresh consent or the implementing of Section 58 procedures is then required before further treatment can be carried out or re-instated. Where the patient withdraws consent he should receive a clear explanation (recorded in the patient’s records) of:

*the likely consequences of not receiving the treatment.
*(where applicable) that a second medical opinion under Part IV ofthe Act may or will be sought in order to authorise treatment in thecontinuing absence of the patient’s consent.
*(where applicable) the doctor’s power to begin or continue treatment under Section 62 until a second medical opinion has been obtained.

Treatments Not Requiring Patient’s Consent (Section 63).

25. Apart from treatment specifically mentioned in Sections 57 and 58, other forms of medical treatment for the mental disorder from which the patient is suffering (so long as they are given by or under the direction of the patient’s responsible medical officer) may be given without the patient’s consent being required (although it should always be sought). Section 63 covers a wide range of therapeutic activities involving a variety of professional staff and includes in particular psychological and social therapies. (See Section 145 of the Mental Health Act 1983 for a definitionof medical treatment).

Urgent Treatment.

26. Any decision to treat a patients urgently under Section 62 is a responsibility of the patient’s responsible medical officer who should bearin mind the following considerations:
a)Treatment can only be given where it is immediately necessary to achieve one of the objects set out in Section 62 and it is not possible to comply with the safeguards of Part 4 of the Act. It is insufficientfor the proposed treatment to be simply “necessary” or “beneficial”.
b)In certain circumstances “hazardous” or “irreversible” treatment cannot be administered under this section even if it is immediately necessary. The patient’s responsible medical officer is responsible for deciding whether treatment falls into either of the categories, having regard to mainstream medical opinion.
c)Urgent treatment given under section 62 can only continue for as long as it is immediately necessary to achieve the statutory objective(s).
d)Before deciding to give treatment under Section 62 the patient’s responsible medical officer should wherever possible discuss the proposed urgent treatment with others involved with the patient’s care.

The Responsible Medical Officer.

27. Treatment under Section 62 of the Mental Health Act 1983 can only be given under the direction of the patient’s (responsible medical officer) consultant.

Special Forms.

28. Any treatment under Section 62 of the Mental Health Act 1983 is recorded on a special form which is available from the Medical Records Office.

29. The form is completed and signed by the patient’s consultant and returned to the Medical Records Office.

Second Opinion.

30. Each treatment of E.C.T. or medication administered under Section 62 of the Mental Health Act 1983 must be recorded on a separate form.

31. If it is intended to continue the use of E.C.T. or medication a request for a second opinion doctor is made at the same time the first treatment is given.

Complying with Provisions of the Mental Health Act.

32. Any system for ensuring compliance with the Consent to TreatmentProvisions of the Mental Health Act must ensure that:

a)The date of the first dose of psychotropic medication is noted.
b)The question of consent is considered about ten weeks from that date.
c)Once a form 38 or form 39 has been completed all prescriptions fall within the plan of treatment described in it OR
d)If a prescription that is not covered by the existing form 38 or 39 is required then a new form 38 or 39 is prepared.
e)The review of treatment for patients subjected to form 39 are carried out.

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Legal Parameters of Informed Consent Applied to Electroconvulsive Therapy

Legal Parameters of Informed Consent Applied to Electroconvulsive Therapy

by John Parry
MPDLR/Vol. 9, No. 3

Past attempts by policy experts and scholars to synthesize the legal policy considerations behind a general limited right to refuse treatment and specific legislative efforts to regulate the use of electroconvulsive therapy (ECT) have met with considerable controversy, confrontation, and misunderstanding. It will be argued on the basis of the following legal analysis that the parameters of the law of informed consent and substituted decisionmaking, as articulated in the leading court decisions and state legislation, provide a reasonable framework upon which to develop sound policy judgments about the right to refuse electroconvulsive therapy.

The components of the law that form the basis for this conclusion, from the most general to the most specific, are: the decisionmaking rights of mentally disabled persons; the principle of informed consent; the law of substituted consent for mentally incompetent persons; and informed consent as applied to ECT. Together, these interrelated and pyramidal legal concerns provide a framework that defines what the law requires before mentally disabled persons may accept or refuse ECT.

Decisionmaking Rights of Mentally Disabled Persons

A broad overview of the decisionmaking rights of mentally disabled persons indicate that while the law could be improved through finer discriminations in the establishment and application of standards that address more precisely the actual abilities and disabilities of each individual, the law does recognize a right of self determination expressed by mental patients or their authorized substitute decisionmakers The free expression of this right usually takes legal precedence over the patient’s medical best interests alone.

While conditions have improved in the institutional “snake pits,” still of recent memory, extremely serious problems persist, as evidenced by testimony before the Senate Subcommittee on the Handicapped earlier this year. From experts that appeared before the subcommittee and other sources, it is known that mentally disabled persons, particularly those individuals who reside in public psychiatric hospitals and other state institutions, are too frequently victims of discrimination, neglect, and abuse.

Beyond the issues of poor care that are identified with inadequate resources and incompetent, or on occasion, mean spirited caregivers, several structural issues involving the law and outmoded models of institutional care exist. In general, mentally disabled persons remain the subjects of overinclusive limits on their decisionmaking rights that are based on labels and categorizations that tend to ignore or exclude individualized assessments of their actual abilities and disabilities. Examples of this phenomenon of unnecessary restrictions can be seen in voting and driving, the overuse of plenary forms of guardianship, and the tendency to rely on institutional care when better, no more expensive placements could be funded in the community, just to cite a few. The medical and social service models often reinforce this tendency towards overinclusive categorizations, due in large part to sincere paternalism and professional self interest.

At the other end of the spectrum, the legal advocacy model of patient representation often tends towards underinclusive categorizations, based on an equally sincere belief in the principle of self determination and similar professional interests.

When this model is used, some individuals who clearly will benefit from care and treatment are allowed to follow the counsel of their own minds, even in circumstances in which caregivers, but not the legal system, are convinced the patients are incompetent to decide for themselves.

What is difficult for many service providers to accept is that the legal advocacy model is consistent with traditional American beliefs and thus reflective of the law as it has been applied to everyone in our society. Even though there have been notable exceptions in which notions of self determination have been compromised where mentally disabled persons were concerned, in general, modern legal theory presumes that every person, mentally disabled or not, is capable of functioning normally in exercising any right or privilege unless facts can be marshaled to demonstrate that specific incapacities exist. The law generally endorses the view that, until a person has been adjudicated incompetent or a legitimate emergency exists and can be demonstrated after the fact, the principle of self determination will win out over the best interests of the individual as reflected by community or medical standards.

Mentally Disabled Persons and Voluntary, Knowing, and Competent Consent

Informed consent is actually three concepts merged together: voluntary, knowing, and competent consent. In general, the principle of informed consent governs the administration of medical care, defining the legal relationship between the patient and the medical provider. Before major changes are recommended and implemented in the existing law of informed consent for mentally disabled persons, it is important to consider that substantial empirical data is missing on how the present laws operate as viewed by patients, the medical providers, and society.

To date, relatively few empirical studies have evaluated the elements of informed consent, particularly the adequacy of the information needed for mentally disabled persons to make informed medical choices. The most comprehensive study to date suggests that the provision of information is inadequate and many patients are not primarily concerned with utilizing available information to make their own decisions. However, even this study was limited in scope, focusing on just three psychiatric units, an evaluation center, a research ward, and an outpatient clinic, all associated with the same university hospital.

Voluntary Consent

The issue of whether consent is voluntarily given takes on particular significance for mentally disabled persons in institutions or hospital settings because so many different factors may undercut the voluntary nature of the consent. Threat of force, coercion, fraud, duress, deceit, and other kinds of overreaching jeopardize the element of voluntariness where decisions of patients or their substitute decisionmakers are improperly influenced.

Only a judge or jury can determine whether any particular actions taken by hospital staff, or conditions within the institution by themselves or in combination with other actions or conditions, constitute sufficient negative influences on the patient to legally invalidate the voluntariness of a decision. However, in a hospital or other institution in which the patients or residents are especially isolated and vulnerable, it seems unwise to presume that any decision is voluntary. While instances of physical abuse, coercion, and fraud appear to be less frequent in the modern mental hospital, such abuses are not yet uncommon, and other kinds of overreaching, including deceit, duress, and threat of force, are still documented as regular occurrences.

Informed or Knowing Consent

Except in a legitimate emergency or as reasonably modified by the application of therapists’ privilege to withhold harmful information from their patients, knowing consent is required before any treatment may be administered. While liability of physicians for not obtaining informed consent is not a frequent occurrence, liability can occur under theories of negligence, or, more rarely, assault and battery.

The so­called community standard, or old rule, was set out in the landmark decision, Natanson v. Kline. In that case, the kind and quality of information a doctor is obliged to communicate to a patient was defined as that information that would be conveyed by typical medical practitioners, either in their specialty area of medicine, generally, or in the geographical area in which they practiced Basically, this standard emphasizes what other doctors would do in similar circumstances.

In contrast, the so called reasonable patient standard, or modern rule, as interpreted in Canterbury v. Spence, emphasizes the right of patients to make their own determinations about medical treatment by providing them with information sufficient to understand the risks and benefits of a given medical procedure and to identify and evaluate the available alternatives. It is the quality of the information that is critical under this standard.

Today, both standards are used, as well as schemes in various jurisdictions that mix elements of each standard. In a few states, entirely new approaches have been enacted such as the use of medical review boards in Texas and Hawaii. Nevertheless, there are case law and statutory modifications to all the schemes that limit the legal protections for patients and strengthen the defenses for doctors.

First, and foremost, is the existence of a medical emergency defined by the presence of two conditions: patients must be so incapacitated that they are incompetent to exercise their decisionmaking rights, and there must be a life­threatening disease or injury that requires immediate treatment. In certain jurisdictions, emergency also includes any condition that would substantially threaten the health of a patient, even if death were not a likely result.

A second defense is the therapeutic privilege. As defined in the case law and statutes, the privilege exists where the total disclosure of information to the patient will have a significant, negative effect on the patient’s condition. In these limited situations, a physician looking at the circumstances from the patient’s point of view may take reasonable steps to communicate or withhold information consistent with the patient’s medical welfare.

A third defense relates to the burden of proof. Since it is the plaintiff who must convince the trier of fact of any wrongdoing on the part of the defendant, the reluctance of many physicians to; testify against their colleagues, no matter what the allegations, may make it difficult, if not impossible, to present a viable claim, even where liability would be certain otherwise.

In addition, a variety of other defenses exist in the case law or on occasion by statute. Medical liability may be denied if: (1) the undisclosed information is common knowledge, (2) there has been a waiver by the patient, (3) there is a written and signed consent form, (4) a reasonable, prudent person would have undergone the procedure anyway, (5) there was no expert medical testimony, or (6) the risk to the patient was insubstantial.

Competent Consent

Exactly what constitutes competent consent varies among jurisdictions and often has very little to do with clinical notions of competency. Even in the broadest formulations, today civil commitment is no longer equivalent to and does not normally include a competency determination. In the most precise formulations, favored by this writer, competency is limited to the specific decisionmaking question that is factually at issue, such as the ability to accept or refuse psychiatric treatment.

Although legal competency is taking on more of the characteristics of clinical competency, there is still a significant gap between the legal and medical conceptual frameworks that are used. These differences, of course, make evaluations of competency less consistent, and errors and disagreements are more likely for everyone concerned.

Most state statutes no longer equate civil commitment with incompetency as was standard 20 or 30 years ago. The law views the two concepts as separate and distinct, although a couple of states such as California and Utah, as well as the American Psychiatric Association’s model commitment statute, make medical decisionmaking an issue to be decided at civil commitment hearings.

The major conceptual problems with making treatment competency an issue at a commitment hearing are the timing of the hearing, which may not be close to the treatment decision, the scope of the competency determination, which does not provide for distinctions among various kinds of treatments nor the capacities necessary to understand different treatment implications, and the possibility that those who are found to be capable of making their own decisions may no longer be committable, even if they are mentally ill and dangerous. To be most accurate, competency should be measured coincident to the decision in question, and be limited to one decision or a narrow range of decisions in which the capacities to be reviewed are very similar.

Except under the emergency conditions discussed previously, any legitimate question regarding a patient’s competency demands court review. If incompetency is proven after evidence on both sides is heard, then the court should decide how the least intrusive treatment decision will be made, consistent with the ward’s mental capacity, medical needs, and previously indicated treatment preferences.

Substitute Consent for Incompetent Persons

Legally, after a person has been adjudicated incompetent to make a specific medical decision, the court should appoint a substitute consent giver to allow the patient to properly exercise his or her right of self­determination. In doing this, the court should review the decision of the patient’s representative to ensure that the decision is not inconsistent with what the patient would have favored if competent. Such a review is not always required, however, and, in fact, often is opposed by medical providers.

As a practical matter, the traditional perception of the physician as the medical decision maker, irrespective of the contrary wishes or nonmedical interests of the patient, is difficult to overcome. If such a role for physicians was ever legally acceptable, it is no longer accepted in the modern law. A far more complete assessment of interests is required, and it is by no means clear that the physician plays a primary role in making such assessments, even when the patient is legally incompetent.

Courts faced with the need for a substitute consent giver have three basic options: (1) allow the physician to make the treatment decisions by either accepting the medical decision without review or assigning the physician the responsibility of making the decision on the patient’s behalf; (2) appoint an independent consent giver to act as a limited guardian or plenary guardian with the patient as the ward; or (3) direct someone to represent the patient’s interest but set out in specific terms what those interests might be and how they should be measured. In each of these situations, the courts may choose to instruct the substitute consent givers whether to apply one of the two leading assessment standards-the patient’s point of view or the patient’s best interests – and then choose to retain jurisdiction for subsequent review of the decision.

The overriding conflict in these treatment matters involves interrelated concerns: the theoretical nature of the decisionmaking at issue and the often competing professional jurisdictions of doctors and lawyers. On the one hand, the judges who interpret and apply the law on the basis of legal briefs and court testimony are unable to assess medical factors with the precision and accuracy of physicians, particularly the physician who is treating the patient. On the other hand, the medical decisionmaking best exercised by physicians does not address the patient’s nonmedical interests, and, in fact, may be inconsistent with other patient interests such as self determination.

By training and experience, judges are better able than doctors to assess all of the legally relevant nonmedical factors, including the patient’s preferences. Moreover, many judges are capable of assessing medical testimony so that it can be utilized in a reasonable way by the trier of fact in arriving at a legal opinion. Finally, regardless of the perceived medical quality of the legal decision, each citizen has the right to judicial review before fundamental liberties are compromised. The solution to the problem of inconsistent judicial decisionmaking must be to improve the judicial process, not to eviscerate Constitutional prerogatives by allowing doctors to assume judicial duties.

The law in recent times has endorsed the due process perspective, at least to the extent of eliminating the alternative in which the physician makes the decision unilaterally without obtaining permission from a guardian or the court. Similarly, the courts generally do not give the treating physician the authority to make the decision on the patient’s behalf unless that authority is accompanied by specific limits on the doctor’s discretion. By and large, courts now demand legal proceedings in which either some kind of guardian is appointed to represent the patient’s interest or the court itself determines what those interests are.

There is one important exception to the right of judicial review and that, as we have discussed, occurs when a medical emergency exists in which the legal process may be too cumbersome to deal with the immediate health needs of a patient. A recurring area of conflict is the applicable definition of emergency and whether it should emphasize a broad medically­oriented standard or a more narrow due process standard for deciding where there is sufficient time to appoint a substitute consent giver. The law appears to be moving towards a compromise between allowing medical actions whenever the patient’s health is at risk and requiring a showing of immediate and substantial threat of death to justify any unilateral actions.

One reasonable legal response to these two more extreme positions is to focus on those medical situations in which doing nothing will in all likelihood make the patient’s long­term prognosis substantially worse. If continued treatment is required, then as soon as is practical a substitute consent giver should be appointed by a court. In essence, this is the standard in Massachusetts under the series of opinions known collectively as the Rogers case.

Regardless of who becomes authorized to make the treatment decision for the patient, there is still the equally ticklish problem of how to assess what is best for the patient. The traditional “best interest” standard, which in recent decisions has lost favor, attempts to measure the community’s response, if collectively its members were in the same situation as the patient.

The predominant standard today is called “substituted consent” and attempts to measure the patient’s response to the issue of treatment, assuming the patient were competent to make the decision. To a significant extent, both standards are legal fictions based on subjective judgments of what either the community or the patient would do in a particular situation. Yet, if self­determination is to be meaningfully retained for the incompetent patient, then substituted consent is the only standard that should be used.

APA Consent Form

APPENDIX B

Sample ECT Consent Documents

1. Consent Form : Acute Phase
2. Consent Form: Continuation/Maintenance ECT
3. Patient Information Sheet

Electroconvulsive Therapy (ECT) Consent Form:
Acute Phase

Name of Patient:__________________

My doctor, ___________________________, has recommended that I receive treatment with electroconvulsive therapy (ECT). This treatment, including the risks and benefits that I may experience, has been fully described to me. I give my consent to be treated with ECT.

Whether ECT or an alternative treatment, like medication or psychotherapy, is most appropriate for me depends on my prior experience with these treatments, the features of my illness, and other considerations. Why ECT has been recommended for me has been explained.

ECT involves a series of treatments, which may be given on an inpatient or outpatient basis. To receive each treatment I will come to a specially equipped area in this facility. The treatments are usually given in the morning. Because the treatments involve general anesthesia, I will have had nothing to eat or drink for several hours before each treatment. Before the treatment, a small needle will be placed in my vein so that I can be given medications. An anesthetic medication will be injected that will quickly put me to sleep. I will then be given another medication that will relax my muscles. Because I will be asleep, I will not experience pain or discomfort or remember the procedure. Other medications may also be given depending on my needs.

To prepare for the treatment, monitoring sensors will be placed on my head and body. Blood pressure cuffs will be placed on an arm and leg. This monitoring involves no pain or discomfort. After I am asleep, a carefully controlled amount of electricity will be passed between two electrodes that have been placed on my head.

I may receive bilateral ECT or unilateral ECT. In bilateral ECT, one electrode is placed on the left side of the head, the other on the right side. In unilateral ECT, both electrodes are placed on the same side of the head, usually the right side. Right unilateral ECT (electrodes on the right side) is likely to produce less memory difficulty than bilateral ECT. However, for some patients bilateral ECT may be a more effective treatment. My doctor will carefully consider the choice of unilateral or bilateral ECT.

The electrical current produces a seizure in the brain. The amount of electricity used to produce the seizure will be adjusted to my individual needs, based on the judgment of the ECT physician. The medication used to relax my muscles will greatly soften the contractions in my body that would ordinarily accompany the seizure. I will be given oxygen to breathe. The seizure will last for approximately one minute. During the procedure, my heart, blood pressure, and brain waves will be monitored. Within a few minutes, the anesthetic medications will wear off and I will awaken. I will then be observed until it is time to leave the ECT area.

The number of treatments that I will receive cannot be known ahead of time. A typical course of ECT is six to twelve treatments, but some patients may need fewer and some may need more. Treatments are usually given three times a week, but the frequency of treatment may also vary depending on my needs.

ECT is expected to improve my illness. However, I understand that I may recover completely, partially, or not at all. After ECT, my symptoms may return. How long I will remain well cannot be known ahead of time. To make the return of symptoms less likely after ECT, I will need additional treatment with medication, psychotherapy, and/or ECT. The treatment I will receive to prevent the return of symptoms will be discussed with me.

Like other medical treatments, ECT has risks and side effects. To reduce the risk of complications, I will receive a medical evaluation before starting ECT. The medications I have been taking may be adjusted. However, in spite of precautions, it is possible that I will experience a medical complication. As with any procedure using general anesthesia, there is a remote possibility of death from ECT. The risk of death from ECT is very low, about one in 10,000 patients. This rate may be higher in patients with severe medical conditions.

ECT very rarely results in serious medical complications, such as heart attack, stroke, respiratory difficulty, or continuous seizure. More often, ECT results in irregularities in heart rate and rhythm. These irregularities are usually mild and short lasting, but in some instances can be life threatening. With modern ECT technique, dental complications are infrequent and bone fractures or dislocations are very rare. If serious side effects occur, the necessary medical care will be provided.

The minor side effects that are frequent include headache, muscle soreness, and nausea. These side effects usually respond to simple treatment.

When I awaken after each treatment, I may be confused. This confusion usually goes away within an hour.

I understand that memory loss is a common side effect of ECT. The memory loss with ECT has a characteristic pattern, including problems remembering past events and new information. The degree of memory problems is often related to the number and type of treatments given. A smaller number of treatments is likely to produce less memory difficulty than a larger number. Shortly following a treatment, the problems with memory are greatest. As time from treatment increases, memory improves.

I may experience difficulties remembering events that happened before and while I received ECT. The spottiness in my memory for past events may extend back to several months before I received ECT, and, less commonly, for longer periods of time, sometimes several years or more. While many of these memories should return during the first few months following my ECT course, I may be left with some permanent gaps in memory.

For a short period following ECT, I may also experience difficulty in remembering new information. This difficulty in forming new memories should be temporary and typically disappears within several weeks following the ECT course.

The majority of patients state that the benefits of ECT outweigh the problems with memory. Furthermore, most patients report that their memory is actually improved after ECT. Nonetheless, a minority of patients report problems in memory that remain for months or even years. The reasons for these reported long-lasting impairments are not fully understood. As with any medical treatment, people who receive ECT differ considerably in the extent to which they experience side effects.

Because of the possible problems with confusion and memory, I should not make any important personal or business decisions during, or immediately following, the ECT course. During and shortly after the ECT course, and until discussed with my doctor, I should refrain from driving, transacting business, or other activities for which memory difficulties may be troublesome.

The conduct of ECT at this facility is under the direction of Dr. ____________________

I may contact him/her at ___________ if I have further questions.

I am free to ask my doctor or members of the ECT treatment team questions about ECT at this time or at any time during or following, the ECT course. My decision to agree to ECT is being made voluntarily, and I may withdraw my consent for further treatment at any time.

I have been given a copy of this consent form to keep.

Date Signature

_________ _________________________

Person Obtaining Consent:

Name Signature

_________ _________________________

Electroconvulsive Therapy (ECT) Consent Form:
Continuation/Maintenance Treatment

Name of Patient:

My doctor, ____________________________ has recommended that I receive continuation or maintenance treatment with electroconvulsive therapy (ECT). This treatment, including, the risks and benefits that I may experience, has been fully described to me. I give my consent to be treated with continuation ECT.

I will receive ECT to prevent relapse of my illness. Whether ECT or an alternative treatment, like medication or psychotherapy, is most appropriate for me at this time depends on my prior experience with these treatments in preventing, the return of symptoms, the features of my illness, and other considerations. Why continuation/maintenance ECT has been recommended for me has been explained.

Continuation/maintenance ECT involves a series of treatments with each usually separated in time by one or more weeks. Continuation /maintenance ECT is usually given for a period of several months or longer. These treatments may be given on an inpatient or outpatient basis.

To receive each continuation/maintenance treatment I will come to a specially equipped area in this facility. The treatments are usually given in the morning. Because the treatments involve general anesthesia, I will have had nothing to eat or drink for several hours before each treatment. Before the treatment, a small needle will be placed in my vein so that I can be given medications. An anesthetic medication will be injected that will quickly put me to sleep. I will then be given another medication that will relax my muscles. Because I will be asleep, I will not experience pain or discomfort or remember the procedure. Other medications may also be given depending on my needs.

To prepare for the treatment, monitoring sensors will be placed on my head and body. Blood pressure cuffs will be placed on an arm and leg. This monitoring involves no pain or discomfort. After I am asleep, a carefully controlled amount of electricity will be passed between two electrodes that have been placed on my head.

I may receive bilateral ECT or unilateral ECT. In bilateral ECT, one electrode is placed on the left side of the head, the other on the right side. In unilateral ECT, both electrodes are placed on the same side of the head, usually the right side. Right unilateral ECT (electrodes on the right side) is likely to produce less memory difficulty than bilateral ECT. However, for some patients bilateral ECT may be a more effective treatment. My doctor will carefully consider the choice of unilateral or bilateral ECT.

The electrical current produces a seizure in the brain. The amount of electricity used to produce the seizure will be adjusted to my individual needs, based on the judgment of the ECT physician. The medication used to relax my muscles will greatly soften the contractions in my body that would ordinarily accompany the seizure. I will be given oxygen to breathe. The seizure will last for approximately one minute. During, the procedure, my heart, blood pressure, and brain waves will be monitored. Within a few minutes, the anesthetic medications will wear off and I will awaken. I will then be observed until it is time to leave the ECT area.

The number of continuation/maintenance treatments that I will receive will depend on my clinical course. Continuation ECT is usually given for at least six months. If it is felt that continuation ECT is helpful and should be used for a longer period (maintenance ECT), I will be asked to consent to the procedure again.

ECT is expected to prevent the return of my psychiatric condition. While for most patients ECT is effective in this way, I understand that this cannot be guaranteed. With continuation/maintenance ECT I may remain considerably improved or I may have a partial or complete return of psychiatric symptoms.

Like other medical treatments, ECT has risks and side effects. To reduce the risk of complications, I will receive a medical evaluation before starting ECT. The medications I have been taking may be adjusted. However, in spite of precautions, it is possible that I will experience a medical complication. As with any procedure using general anesthesia, there is a remote possibility of death from ECT. The risk of death from ECT is very low, about one in 10,000 patients. This rate may be higher in patients with severe medical conditions.

ECT very rarely results in serious medical complications, such as heart attack, stroke, respiratory difficulty, or continuous seizure. More often, ECT results in irregularities in heart rate and rhythm. These irregularities are usually mild and short lasting, but in some instances can be life threatening. With modem ECT technique, dental complications are infrequent and bone fractures or dislocations are very rare. If serious side effects occur, the necessary medical care will be provided.

The minor side effects that are frequent include headache, muscle soreness, and nausea. These side effects usually respond to simple treatment.

When I awaken after each treatment, I may be confused. This confusion usually goes away within an hour.

I understand that memory loss is a common side effect of ECT. The memory loss with ECT has a characteristic pattern, including problems remembering past events and new information ion. The degree of memory problems is often related to the number and type of treatments given. A smaller number of treatments is likely to produce less memory difficulty than a larger number. Shortly following a treatment, the problems with memory are greatest. As time from treatment increases, memory improves.

I may experience difficulties remembering events that happened before and while I received ECT. The spottiness in my memory for past events may extend back to several months before I received ECT, and, less commonly, for longer periods of time, sometimes several years or more. While many of these memories should return during the first few months following continuation ECT, I may be left with some permanent gaps in memory.

For a short period following each treatment, I may also experience difficulty in remembering new information. This difficulty in forming new memories should be temporary and will most likely disappear following completion of continuation/maintenance ECT.

The effects of continuation/maintenance ECT on memory are likely to be less pronounced than those during an acute ECT course. By spreading treatments out in time, with an interval of a week or more between treatments, there should be substantial recovery of memory between each treatment.

Because of the possible problems with confusion and memory, it is important that I not drive, or make any important personal or business decisions the day that I receive a continuation/maintenance treatment. Limitations on my activities may be longer depending on the side effects I experience following each treatment, and will be discussed with my doctor.

The conduct of ECT at this facility is under the direction of Dr. _________________

I may contact him/her at ___________if I have further questions.

I am free to ask my doctor or members of the ECT treatment team questions about ECT at this time or at any time during or following the ECT course. My decision to agree to continuation/maintenance ECT is being made voluntarily, and I may withdraw my consent for future treatment at any time.

I have been given a copy of this consent form to keep.

Date Signature

_________ _________________________

Person Obtaining Consent:

Name Signature

_________ _________________________

Sample Patient Information Booklet

Electroconvulsive Therapy

What is Electroconvulsive Therapy?

Electroconvulsive therapy (ECT or shock treatment) is an extremely safe and effective medical treatment for certain psychiatric disorders. With this treatment, a small amount of electricity is applied to the scalp and this produces a seizure in the brain. The procedure is painless because the patient is asleep, under general anesthesia.

Who is Treated with ECT?

ECT has been used for over 60 years. In the United States, about 100,000 individuals are estimated to receive ECT each year. ECT is most commonly given when patients have severe depressive illness, mania, or some forms of schizophrenia. Frequently, ECT is given when patients have not responded to other treatments, when other treatments appear to be less safe or difficult to tolerate, when patients have responded well to ECT in the past, or when psychiatric or medical considerations make it particularly important that patients recover quickly and fully.

Not all patients improve when treated with medications or psychotherapy (talk therapy). Indeed, when illnesses such as depression become particularly severe, it is doubtful that psychotherapy alone will be sufficient. For some patients, the medical risks of medications are greater than the medical risks of ECT. Typically, these are people with serious medical problems, such as some types of heart disease. When patients have life-threatening psychiatric problems, such as suicidal tendencies, ECT is also often recommended because it usually provides faster relief than medications. Overall, about 70 to 90% of the depressed patients treated with ECT show substantial improvement. This makes ECT the most effective of the antidepressant treatments.

Who Administers ECT?

A treatment team gives ECT. The team consists of a psychiatrist, an anesthesiologist, and nurses. The physicians responsible for administering ECT are experienced specialists. ECT is administered in a dedicated suite at the (name of facility) The suite contains a waiting, area, a treatment room, and a recovery room.

How is ECT Given?

Before ECT is administered, the patient’s medical condition is carefully assessed. This includes a complete medical history, physical examination, and medical tests, as needed. The treatments are usually given three times per week in the morning on Monday, Wednesday and Friday. Before each treatment, the patient should not eat or drink anything after midnight. Patients should also try to refrain from smoking during the morning prior to the treatment.

When the patient comes to the ECT treatment room, an intravenous line is started. Sensors for recording, EEG (electroencephalogram, a measure of brain activity) are placed on the head. Other sensors are placed on the chest for monitoring EKG (electrocardiogram). A cuff is wrapped around an arm for monitoring blood pressure. When everything is connected and in order, an anesthetic medication (methohexital) is injected through the intravenous line that will cause the patient to sleep for 5 to 10 minutes. Once the patient falls asleep, a muscle relaxant (succinylcholine) is injected. This prevents movement, and during the seizure there are only minimal contractions of the muscles.

When the patient is completely asleep and the muscles are well relaxed, the treatment is given. A brief electrical charge is applied to electrodes on the scalp. This stimulates the brain and produces the seizure that lasts for about a minute. Throughout the procedure, the patient receives oxygen through a mask. This continues until the patient resumes breathing on his or her own. When the treatment is completed, the patient is taken to a recovery area for monitoring by trained staff. Usually within 30 to 60 minutes, the patient can leave the recovery area.

How Many Treatments are Needed?

ECT is given as a course of treatments. The total number needed to successfully treat psychiatric disturbance varies from patient to patient. For depression, the typical range is from 6 to 12 treatments, but some patients may require fewer and some patients may require more treatments.

Is ECT Curative?

ECT is extremely effective in providing relief from psychiatric symptoms. However, permanent cures for psychiatric illness are rare, regardless of the treatment given. To prevent relapse following ECT, most patients require further treatment with medications or with ECT. If ECT is used to protect against relapse, it is usually administered to outpatients on a weekly to monthly basis.

How Safe is ECT?

It is estimated that death associated with ECT occurs in one of 10,000 patients. This rate may be higher in patients with severe medical conditions. ECT appears to have less risk of death or serious medical complications than a number of the medications used to treat psychiatric conditions. Because of this strong safety record, ECT is often recommended for patients with serious medical conditions. With modem anesthesia, fractures and dental complications are very rare.

What are the Common Side Effects of ECT?

The patient will experience some confusion on awakening following, the treatment. This is partly due to the anesthesia and partly due to the treatment. The confusion typically clears within an hour. Some patients have headaches following the treatment. This is usually relieved by Tylenol or aspirin. Other side effects, such as nausea, last for a few hours at most and are relatively uncommon. In patients with heart disease, there is an increased risk of cardiac complications. Cardiac monitoring and other precautions, including the use of additional medications if required help to ensure a safe treatment.

The side effect of ECT that has received the most attention is memory loss. ECT results in two types of memory loss. The first involves rapid forgetting of new information. For example, shortly following the treatment, patients may have difficulty remembering conversations or things they have recently read. This type of memory loss is short-lived and has not been shown to persist for more than a few weeks following the completion of ECT. The second type of memory loss concerns events from the past. Some patients will have gaps in their memory for events that occurred in the weeks to months and, less commonly, years prior to the treatment course. This memory loss also reverses following the completion of ECT. However, in some patients there may be permanent gaps in memory for events that occurred close in time to the treatment. However, like with any treatment, patients differ in the extent to which they experience side effects, and more extensive memory loss has been reported by a minority of individuals. It is known that the effects on memory are not necessary to obtain the benefits of ECT.

Many psychiatric illnesses result in impairments of attention and concentration. Consequently, when the psychiatric disturbance improves following ECT, there is often improvement in these aspects of thinking. Shortly following, ECT, most patients show improved scores on tests of intelligence, attention, and learning.

Does ECT Cause Brain Damage?

The scientific evidence strongly speaks against this possibility. Careful studies in animals have shown no evidence of brain damage from brief seizures, like those given with ECT. In the adult, seizures must be sustained for hours before brain damage can occur, yet the ECT seizure lasts only for about a minute. Brain imaging studies following ECT have shown no changes in the structure or composition of the brain. The amount of electricity used in ECT is so small that it cannot cause electrical injury.

How Does ECT Work?

Like many other treatments in medicine, the exact process that underlies the effectiveness of ECT is uncertain. It is known that the benefits of ECT depend on producing a seizure in the brain and on technical factors in how the seizure is produced. Biological changes that result from the seizure are critical to effectiveness. Most investigators believe that specific changes in brain chemistry produced by ECT are the key to restoring normal function.

Considerable research is being conducted to isolate the critical biochemical processes.

Is ECT Frightening?

ECT has often been portrayed in the movies and TV as a painful procedure, used to control or punish patients. These portrayals have no resemblance to modem ECT. One survey found that following ECT most patients reported that it was no worse than going to the dentist, and many found ECT less stressful. Other research has shown that that the vast majority of patients report that their memory is improved following ECT and that if needed, they would receive ECT again.

ECT is an extremely effective form of treatment. It is often safer and more effective than medications or no treatment at all. If you have any questions about ECT, please discuss them with your physician. You may also wish to read one of the following books. Both books were written by psychologists who were against people having ECT until they each had a severe depression and needed the treatment. Drs. Endler and Manning describe their illness, their experience in treatment with medication and psychotherapy, and their experience with ECT.

HOLIDAY OF DARKNESS
by Norman S. Endler
Wall & Thompson, Toronto
1990

UNDERCURRENTS: A THERAPIST’S
RECKONING WITH DEPRESSION
by Martha Manning
Harper, San Francisco
1995