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.