Chapter 8: Consent for ECT|
"The core notion that decisions regarding medical care are to be made in a collaborative manner between patient and physician" has, over the last few decades, evolved into a formal legal doctrine of informed consent (Appelbaum et al. 1987, p. 12). Such doctrine serves to focus on a number of important questions regarding the nature of consent to treatment. What is informed consent? Who should provide consent, and under what circumstances? How, and by whom, should capacity for consent be determined? What information should be provided to the consentor and by whom? And how should consent be managed with incompetent or involuntary patients? General reviews of informed consent issues as they relate to ECT can be found in Parry (1986), Roth (1986), Taub (1987), and Winslade (1988), while capacity for consent and the use of ECT in incompetent and/or involuntary patients is specifically addressed in Roth et al. (1977), Salzman (1977), Culver et al. (1980), Roy-Byrne and Gerner (1981), Gutheil and Bursztajn (1986), Mahler et al. (1986), Applebaum et al. (1987), Wettstein and Roth (1988), Levine et al (1991), Reiter-Theil (1992), Martin and Bean (1992), Martin and Clancy (1994), Bean et al (1994), and Boronow et al (1997).
The psychiatric profession, both in the United States and elsewhere, has made a number of attempts to offer practical guidelines for the implementation of consent in the clinical setting. In this regard, the conceptual requirements for informed consent posed by the 1978 APA Task Force on ECT are still applicable; 1) a patient who is capable of understanding and acting reasonably upon such information, 2) the provision of adequate information, and 3) the opportunity to consent in the absence of coercion (American Psychiatric Association 1978). Specific recommendations concerning consent for ECT often reflect a trade-off between the preservation of the autonomy of the patient and the assurance of the patient's right to receive treatment (Ottosson 1992).
A crucial hallmark of informed consent is the quality of interactions between the consentor and the physician, particularly since consent for ECT is an ongoing process. In general, the more the physician keeps the consentor abreast of what is transpiring and involves the consentor in everyday decision making, and the more he/she is sensitive to the consentor's concerns and feelings regarding, these decisions, the fewer problems there will be with the consent process.
8.2 The Requirement for Consent.
Since informed consent for ECT is mandated, both ethically and by regulation, it is incumbent upon facilities using ECT to implement and monitor compliance with reasonable and appropriate policies and procedures. Although the practitioner legally obliged to follow state and local regulatory requirements concerning consent for ECT, judicial and political efforts should be made to correct overregulation (Winslade et al. 1984; Taub 1987). In this regard, ECT should not be considered different from other medical or surgical procedures with comparable risks and benefits. Regulations should not unduly obstruct the patient's right to treatment, since unnecessary suffering, increased physical morbidity, and even fatalities may result if procedures to provide ECT to incompetent or involuntary patients (see below) are needlessly prolonged (Mills and Avery 1978; Roy-Byrne and Gerner 1981; Tenenbaum 1983; Walter-Ryan 1985; Miller et al. 1986; Johnson 1993).
8.3 When and by Whom Should Consent Be Obtained?
As with consent for medical and surgical procedures, the patient should provide informed consent unless lacking capacity or otherwise specified by law. The involvement of significant others in this process should be encouraged (Consensus Conference 1985) but not required (Tenenbaum 1983).
ECT is unusual, but not unique, among medical procedures in that it involves a series of repetitive treatments over an appreciable time period (typically 2 to 4 weeks for an acute ECT course). Because it is the series of treatments, rather than any single treatment, that confers both the benefits and adverse effects of ECT, consent should apply to the treatment series as a whole (unless otherwise required by state law).
Since an ECT course generally extends over multiple weeks, the informed consent process should continue across this period. Patient recall of consent for medical and surgical procedures is commonly faulty (Roth et al. 1982; Miesel and Roth 1983; Herz et al 1992; Hutson and Blaha 1991; Swan and Borshoff 1994). For patients receiving ECT, this recall difficulty may be exacerbated by both the underlying illness and the treatment itself (Sternberz and Jarvik 1976; Squire 1986). For these reasons, the consentor should be provided ongoing feedback regarding clinical progress and side effects and any questions should be addressed. Particularly if the consentor expresses reluctance about receiving ECT, h/she should be reminded of his/her right to accept or refuse further treatment.
Continuation/maintenance ECT (see Chapter 13) differs from a course of ECT in that (1) its purpose is the prevention of relapse or recurrence, (2) the patient's clinical condition is improved compared to that preceding the index ECT course, and (3) it is characterized by both a greater inter-treatment interval and a less well-defined endpoint. Because the purpose of continuation/maintenance treatment differs from an acute course of ECT, a new informed consent process should be initiated, including the signing of a separate consent form. As a series of continuation ECT typically lasts at least 6 months, and because continuation/ maintenance ECT is provided to individuals who are clinically improved and already knowledgeable about the treatment, a 6-month interval is adequate before readministration of the formal consent document (unless state law requires otherwise).
Ideally, the consent process involves discussions with the consentor about general aspects of ECT and information unique to the patient, as well as the signing of the informed consent document. The information essential to consent to ECT should be provided by a knowledgeable physician. Ideally, this person should also have a therapeutic alliance with the patient. In practice this requirement can be accomplished by the attending physician, treating psychiatrist, or other knowledgeable physician acting individually or in concert. It may also be helpful for other, professional staff to provide further information to the consentor. Consent for anesthesia may either be included in the ECT consent process or separately obtained by an anesthetist.
8.4 Information to Be Conveyed
The use of a formal consent document for ECT ensures the provision of essential information to the consentor. Earlier task force recommendations (American Psychiatric Association 1978, 1990), other professional Guidelines, and regulatory requirements (Mills and Avery 1978; Tenenbaum 1983); Winslade et al. 1984; Taub 1987; Winslade 1988) have encouraged the use of comprehensive written information about ECT as part of the consent process. Such material may either be contained wholly within the formal consent document, or included as a patient information supplement. In either case, informational material should be given to the consentor to keep. In surgical patients, patient information supplements have been shown to significantly enhance recall of information provided prior to surgery (Askew et al 1990).
Sample consent forms and supplementary patient information material are included in Appendix B. If these documents are used, appropriate modifications should be made to reflect local requirements. It is also suggested that reproductions be in large type, to ensure readability by patients with poor visual acuity. To further enhance the understanding of ECT, many practitioners now augment written materials with use of videotapes designed to cover the topic of ECT from the layman's perspective (Baxter et al. 1986; Guze et al. 1988; Battersby et al. 1993; Dillon 1995; Westreich et al. 1995). A listing of such materials has been included as part of Appendix C.
However, to rely entirely upon such generic materials as the sole informational component of the informed consent process would be ill advised. Even with considerable attention to readability, many patients understand less than half of what is contained in a typical medical consent form (Roth et al. 1982). In this regard, it is interesting to note that psychiatric patients do not perform more poorly than medical or surgical patients (Miesel and Roth 1983). Because of this situation, in addition to written information given to the patient, a discussion between the consentor and a knowledgeable physician should take place. This discussion should summarize the main features of the consent document, provide additional information applicable to that individual, and allow a further opportunity for the consentor to express opinions and have questions answered. Examples of individual-specific information include: the rationale for ECT, reasonable treatment alternatives, specific benefits and risks, and any major alterations planned in the ECT procedure. This discussion should also be briefly summarized in the patient's clinical record.
Substantial alterations in the treatment procedure or other factors having a major effect upon risk-benefit considerations should be conveyed to the consentor on a timely basis and documented in the patient's clinical record. The need for ECT treatments exceeding the typical range (see Section 11.11) and the switching of stimulus electrode placement (see Section 11.6) represent two such examples.
Informational material provided as part of the consent process should be sufficient in scope and depth to allow a reasonable person to understand and evaluate the risks and benefits of ECT as compared to treatment alternatives. Since individuals vary considerably in education and cognitive status, efforts should be made to tailor information to the consentor's ability to comprehend such data. In this regard, the practitioner should be aware that too much technical detail can be as counterproductive as too little. The readability of consent forms should be no greater than at a 10th grade level to optimize comprehension (some contemporary word processing software packages capable of easily determining readability - the consent documents in Appendix B meet this criterion).
Topics to be covered in the consent document generally include the following:
1) a description of the ECT procedure, including the times when treatments are given (e.g., Monday, Wednesday, Friday mornings , general location of treatment (i.e., where treatments will take place), and typical range for number of treatments to be administered
2) why ECT is being recommended and by whom
3) that there is no guarantee that ECT will be effective
4) that there is generally a substantial risk of relapse following ECT, and that continuation treatment of some sort is nearly always indicated
5) a generic mention of applicable treatment alternatives
6) the likelihood (e. g., "extremely rare," "rare," "uncommon," or "common"), and anticipated severity of major risks associated with the procedure (see Chapter 5), including mortality, adverse effects upon cardiovascular and central nervous systems (including both transient and persistent amnesia), and common minor side-effects. In light of the accumulated body of data dealing with structural effects of ECT (Devenand et al 1994), "brain damage" should not be included as a potential risk.
7) an acknowledgement that consent for ECT also implies consent for appropriate emergency treatment in the event that this is clinically indicated
8) a description of behavioral restrictions that may be necessary during the pre-ECT evaluation period, the ECT course, and the recuperative interval
9) 10) a statement that consent for ECT is voluntary and can be withdrawn at any time
11) 10) an offer to answer questions at any time regarding the recommended treatment and the name of whom to contact for such questions
8.5 Capacity to Provide Voluntary Consent.
Informed consent requires that a patient be capable of understanding and acting reasonably upon information provided to him/her about the procedure. For the purpose of these recommendations, the term "capacity" reflects this criterion. There is no clear consensus as to what constitutes "capacity to consent." Criteria for capacity to consent have tended to be vague, and formal "tests" of capacity are only now under active investigation (Bean et al 1996; Grisso and Appelbaum 1995; Martin et al 1994). It is suggested, instead, that the individual obtaining consent consider the following general principles in making a determination. First, capacity to consent should be assumed to be present unless compelling evidence to the contrary exists. Second, the occurrence of psychotic ideation., irrational thought processes, or involuntary hospitalization do not in themselves constitute such evidence. Third, the patient should demonstrate sufficient comprehension and retention of information so that he/she can reasonably make a decision whether or not to consent for ECT.
Unless otherwise mandated by statute, a determination of capacity is generally made by the attending physician. First, the attending physician is in an excellent position to assess the patient's ability to meet the above three criteria for capacity to consent. Also, the attending physician is likely to be aware of how the patient's mental illness affects these criteria. Finally, the attending physician is generally the one who makes such determination with respect to other medical and surgical procedures. Should the attending physician be in doubt as to whether capacity to consent is present, use may be made of an appropriate physician consultant not otherwise associated with the patient's care.
There is concern that attending physicians may be biased to find that capacity to consent exists when the patient's decision agrees with their own. In this regard, however, ECT is no different from other treatment modalities. Fixed requirements for a priori review of capacity to consent for ECT by consultant, special committee, appointed lawyer, or judicial hearing are impediments to the patient's right to treatment and are inappropriate.
Patients who have previously been adjudicated legally incompetent or medical purposes usually have consent provided by a legally appointed guardian or conservator, although this may vary depending upon jurisdiction.
For patients with capacity to consent, ECT should only be administered with the agreement of the patient. To do otherwise would infringe upon the right to refuse treatment. Situations where the patient lacks capacity to consent for ECT are generally covered by regulations which include how and from whom surrogate consent may be obtained. In such instances, all the information typically provided regarding ECT and alternative treatment should be shared with this individual.
Informed consent is defined as voluntary when the consentor's ability to reach a decision is free from coercion or duress. Since the treatment team, family members, and friends all may have opinions concerning whether or not ECT should be administered, it is reasonable that these opinions and their basis be expressed to the consentor. In practice, the line between "advocacy" and "coercion" may be difficult to establish. Consentors who are either highly ambivalent or are unwilling or unable to take full responsibility for the decision (neither of which are rare occurrences with patients referred for ECT) are particularly susceptible to undue influence. Staff members involved in clinical case management should keep these issues in mind.
Threats of involuntary hospitalization or precipitous discharge from the hospital due to ECT refusal clearly represent undue influence. However, consentors do have the right to be informed of the anticipated effects of their actions on the clinical course and the overall treatment plan. Similarly, since physicians are not expected to follow treatment plans which they believe are ineffective or unsafe, an anticipated need to transfer the patient to another attending physician should be discussed in advance with the consentor. It is important to understand the issues involved in a consentor's decision to refuse or withdraw consent. Such decisions may sometimes be based upon misinformation or may reflect unrelated matters, e.g., anger towards self or others or a need to manifest autonomy. In addition, a patient's mental disorder can itself limit the ability to cooperate meaningfully in the informed consent process, even in the absence of psychosis.
A number of suggestions have been offered to help guarantee the right of involuntarily hospitalized patients to accept or refuse specific components of the treatment plan, including ECT. Examples of such recommendations include the use of psychiatric consultants not otherwise involved in the patient's care, appointed lay representatives, formal institutional review committees, and legal or judicial determination. While some degree of protection is indicated in such cases, overregulation will serve to limit unnecessarily the patient's right to receive treatment.
8. 1. General
a) Policies and procedures should be developed to assure proper informed consent, including when, how, and from whom it is to be obtained, and the nature and scope of information to be provided.
b) These policies and procedures should be consistent with state and local regulations.
8.2. The Requirement for Consent
a) Informed consent should be obtained from the patient except in situations where the patient lacks capacity to do so (see Section 8.5.3).
b) Informed consent for ECT is given for a specified treatment course or for a period of continuation/maintenance ECT (see Section 13.3).
c) Consent for future treatments may be withdrawn at any time, including, between ECT treatments, by the individual providing consent.
8.3. When and by Whom Should Consent Be Obtained?
a) Informed consent for ECT, including the signing of a formal consent document, should be obtained before beginning an ECT treatment course or a period of continuation or maintenance ECT. In the latter case, the consent process should be repeated at least every six months.
b) Informed consent should be obtained by the patient's attending physician, treating psychiatrist or other physician knowledgeable about both the patient and ECT (unless otherwise specified by law).
c) When separate informed consent for ECT anesthesia is required, it should be obtained by a privileged or otherwise authorized anesthesia provider.
d) The consentor should be provided ongoing feedback regarding clinical progress and side effects and any questions or concerns should be addressed.
e) If the consentor expresses reluctance about the treatment at any time prior to or during the ECT course, h/she should be reminded of his/her right to accept or refuse treatment.
8.4. Information to Be Conveyed
8.4.1. General Considerations
a) Information describing ECT (see below) should be conveyed in a written consent document. This document and/or a summary of general information related to ECT should be given to the consentor to keep (examples are provided in Appendix B). The use of a separate consent document may be required for anesthesia with ECT in certain settings.
b) The use of appropriate video format patient information on ECT is encouraged.
c) In addition to the written consent document an overview of general information on ECT and individual-specific data should be presented orally by the attending physician, treating psychiatrist, or other knowledgeable physician. Further information may also be provided by other staff members.
d) The consentor should be informed if substantial alterations in the treatment procedure arise that may have a major effect upon risk-benefit considerations.
e) Significant discussions with the consentor regarding these issues should be documented in the clinical record.
f) All information should be provided in a form understandable to the consentor, and should be sufficient to allow a reasonable person to understand the risks and benefits of ECT and to evaluate the available treatment options.
g) The consentor should have an opportunity to ask questions relevant to ECT or treatment alternatives.
8.4.2. Specific Information Provided
The consent document should provide:
a) a description of ECT procedures including:
1) when, where, and by whom the treatments will be administered
2) a range of the number of treatment sessions likely
3) a brief overview of the ECT technique itself.
b) a statement of why ECT is being recommended and by whom, including a general consideration of treatment alternatives.
c) a statement that, as with any treatment modality, therapeutic (or prophylactic) benefits associated with ECT may be absent or transient.
d) a statement indicating the need for continuation therapy.
e) a statement as to the likelihood and severity (in general terms) of the risks related to anesthesia and seizure induction: including mortality, cardiac dysfunction, confusion, acute and persistent memory impairment, musculoskeletal and dental injuries, headaches, and muscle pain.
f) a statement that, as with any other procedure involving general anesthesia, consent for ECT also implies consent to perform appropriate emergency medical interventions in the unlikely event that this proves necessary during the time the patient is not fully conscious.
g) a statement that consent is voluntary and can be revoked at any time before or during the treatment course.
h) a statement that the consentor is encouraged to ask questions at any time regarding ECT, and whom to contact for such questions.
1) a description of any restrictions on patient behavior that are likely to be necessary before, during,, or following ECT.
8.5. Capacity to Provide Voluntary Consent
8.5.l. General Considerations
a) The use of ECT requires voluntary consent from an individual with capacity to make such a decision.
b) Individuals with mental illness are considered to have the capacity to consent to ECT unless the evidence to the contrary is compelling. The presence of psychosis, irrational thinking, or involuntary hospitalization do not in themselves constitute proof of lack of capacity.
c) Unless otherwise specified by statute, the determination of capacity to consent should generally be made by the patient's attending physician, with use of an appropriate physician consultant not otherwise associated with the patient's care in cases where the attending physician is uncertain as to whether capacity to consent is present.
d) In the event of refusal or withdrawal of consent to ECT, the attending physician and/or treating, psychiatrist should inform the consentor of anticipated effects of this action upon clinical course and treatment planning.
8.5.2. Patients Having the Capacity to Provide Consent
In this case, ECT should only be administered in the presence of voluntary patient agreement, including signing of a formal consent document.
8.5.3. Patients Lacking the Capacity to Provide Consent
State and local law covering consent to treatment for patients lacking the capacity to provide such consent should be followed, including statutes pertinent to emergency situations where a delay in treatment may lead to death or serious impairment in health. Applicable legal requirements vary considerably by jurisdiction and are subject to revision over time. Surrogate decision makers should be provided with the information described above. Consideration should be given to any positions previously expressed by the patient when in a state of determined or presumed capacity, as well as to the opinions of major significant others.