Psychiatrists' Documentation of Informed Consent: A Representative Survey
Schachter, Debbie, Kleinman, Irwin, Canadian Journal of Psychiatry
Objective: To review psychiatrists' documentation of informed consent and present data on Canadian psychiatrists' attitudes and practices regarding documentation of the informed consent process.
Method: We surveyed a stratified random sample of psychiatrists practising in Ontario, using a mailed self-report questionnaire.
Results: The response rate was 72%. Among respondents, 63% routinely documented the consent process, with younger respondents reporting more documentation than older ones. Although most respondents (77%) favoured recording the consent process, only 11% felt signed consent forms were necessary.
Conclusion: There are differences in the self-reported documentation behaviour of younger and older psychiatrists. Psychiatrists should document the consent process in the clinical record.
(Can J Psychiatry 2006;51:438-444)
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* Many psychiatrists do not routinely document the consent process.
* Older psychiatrists are reminded to document the consent process.
* Psychiatrists do not favour the use of signed consent forms for antipsychotic medication.
* The participation rate was only 72%.
* The survey was conducted prior to widespread use of atypical antipsychotic medication.
* Data are needed regarding current documentation practices.
Key Words: informed consent, documentation, antipsychotic medication, health record
Abbreviations used in this article
APA American Psychiatric Association
CI confidence interval
CME continuing medical education
EPSE extrapyramidal side effect
OR odds ratio
TD tardive dyskinesia
Medical practitioners obtain informed consent for treatment prior to all medical interventions. This process reflects our respect for the autonomy of the individual. The elements of informed consent are that the patient has the capacity or ability to consent, that the individual has received an adequate disclosure of the relevant information, and that the patient provides consent voluntarily (1). The informed consent process gives patients information about the nature of the proposed treatment, the benefits and risks of the proposed treatment, and the benefits and risks of alternative treatments, including the option of no treatment. The standard of disclosure is to disclose the information that a reasonable patient in the patient's situation would want to have to make an informed decision (2,3). Canadian judicial decisions have stated that all material risks need to be disclosed as part of the informed consent disclosure (3,4). Informed consent therefore permits patients to make treatment decisions according to their own values and beliefs.
The informed consent process for antipsychotic medications is particularly important and complex, for several reasons. First, many patients for whom antipsychotic medications are prescribed have schizophrenia. Although many patients with schizophrenia are able to participate in medical decision making, the severity of their symptoms may reduce the ability of some patients to understand the information presented during the informed consent process (5,6).
Second, both the classical and the newer antipsychotic medications have serious side effects associated with their long-term use (7). The classical antipsychotic medications have a range of side effects, including prominent EPSEs such as TD, a potentially irreversible movement disorder that affects about 25% of patients (8,9). Because of this potentially serious side effect, the APA specifically recommended that information about TD be included in the informed consent process (8). Even though the newer atypical antipsychotic medications hold the promise of fewer EPSEs and a reduced risk of TD, they have been associated with serious metabolic and cardiac difficulties and significant weight gain (7). …