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 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). This information should also be shared with patients as part of the informed consent process. A third issue that adds to the complexity of the informed consent process for antipsychotic medications is psychiatrists’ attitudes to the process. Some psychiatrists are concerned about the effect of disclosure on patient compliance and about whether disclosure of TD is in patients’ best interest (10,11). Given the importance of informed consent, the complexity of the process with patients suffering from psychosis, and the finding that many patients who have been informed about medication do not always recall having been informed (12–15), the APA has recommended that psychiatrists document the informed consent process in the medical record (8). The APA did not recommend written signed consent forms because their use might introduce an adversarial element to the physician–patient relationship (16). Others, however, have argued in favour of the merits of signed consent forms (17). Relatively few studies exist about psychiatrists’ documentation practices and attitudes toward documentation. In US settings where state or hospital guidelines recommend the use of consent forms or checklists to facilitate documentation, documentation rates are 39% (18,19). A study of Canadian psychiatrists’ chart records found that 23% contained documentation (20). Most of these psychiatrists thought that the informed consent process should be recorded but felt that written consent forms were not necessary. In another Canadian study on the documentation of EPSEs in the health records of patients treated with antipsychotic medication, most records showed no documentation of TD in the admission, consultation, progress, and discharge notes; consent documentation was not examined (21). The present study provides representative data on psychiatrists’ behaviour and attitudes regarding documentation of the informed consent process for antipsychotic medication use and the physician characteristics associated with documentation. Some data suggest practice differences between younger and older physicians as well as between male and female physicians (22). We hypothesized that younger and (or) female physicians would have more favourable documentation practices than would older or male physicians. MethodIn 1996, we surveyed a cross-sectional representative sample of psychiatrists drawn from 1643 psychiatrists licensed to practise medicine in Ontario. We obtained a random sample of 617 psychiatrists, stratified by age (under 40 years or 40 years and older) and sex, from the College of Physicians and Surgeons of Ontario, the provincial medical licensing body. Questionnaires were mailed to 164 men and 146 women aged 40 years and over and to 161 men and 146 women under age 40 years. The initial mailing was followed by 2 additional mailings to nonrespondents. Nonrespondents received a telephone reminder before the third mailing. Respondents completed the questionnaires anonymously, and a separately returned identification card tracked them. Our hospital’s Research Ethics Board approved this study. Consent was implied by return of the completed questionnaire or identification card. Questionnaire The self-report questionnaire addressed physicians’ disclosure practices regarding the benefits and risks of antipsychotic medication, their documentation behaviour, and their attitudes to informed consent. Individual items were answered according to a 5-point Likert scale.We constructed 2 scales from the questionnaire: the Behaviour Scale and the Antipsychotic Attitude Scale. The Behaviour Scale summarized the information disclosed regarding the benefits and risks of antipsychotic medication and was the sum of the individual items. Two items in the Antipsychotic Attitude Scale examined attitudes toward consent documentation. The questionnaire was a shortened version of one previously studied (20). Reliability and Validity Nineteen psychiatrists and family physicians evaluated the questionnaire’s face and content validity. We evaluated the questionnaire’s (revised) criterion validity by comparing the self-reported responses of 60 psychiatrists and general practitioners with their spontaneous disclosures in a structured interview; we also conducted a chart review to determine documentation practices. Self-reported documentation correlated moderately with chart documentation for competent patients (r = 0.50, n = 54; P < 0.001, 2-tailed). Physicians did not appear to be answering on the basis of socially desirable behaviour; self-reported behaviours did not correlate significantly with Marlowe-Crowne Social Desirability Scale scores (23). The current questionnaire was shortened for use in a large postal survey. Test–retest reliability according to the intraclass correlation coefficient was 0.64 for self-reported documentation behaviour in competent patients’ charts and 0.59 for self-reported obtaining of written consent from competent patients (n = 32; P < 0.001, 2-tailed). Data Analysis We designed our study to detect a difference of 0.67 standard deviation in scores between the study strata, with alpha of 0.01 and 80% power. Differences between strata response rates for items were analyzed with chi-square statistics. We examined potential interactions in response rates across strata with logistic regression analyses. To examine the correlation between different items on the questionnaire, we treated the responses to the Likert-style questions as continuous variables. To analyze the responses to items on documentation behaviour, we collapsed data into 3 categories (always or almost always, sometimes, and never or almost never); we analyzed the data with ordinal logistic regression analyses. In the final ordinal logistic regression model with documentation behaviour as the outcome variable, we dichotomized the following predictor variables: attitudes to documentation and disclosure of TD. ResultsThe psychiatrists’ response rate was 72% (n = 427) after we excluded 19 psychiatrists who were ineligible for reasons including retirement, having moved, illness, not being in active practice, or unavailability. The sample’s demographic characteristics have been described elsewhere (11). As reported previously, 77.6% (n = 243) of the sample routinely (that is, always or almost always) disclosed the side effect of TD; 3% (n = 9) reported never or almost never disclosing TD (11). Table 1 presents stratum-specific responses and reponse rates. For the TD item, younger physicians were more likely to respond than older physicians (c2 = 12.30, df 1, P < 0.001); there was no significant sex effect and no significant interaction between sex and age on response rates.
Among respondents, 62.9% (n = 224) reported routinely (always or almost always) documenting the informed consent process in charts for competent patients; 26.4% (n = 94) reported sometimes documenting consent; and 10.6% (n = 38) reported never or almost never documenting it. For stratum-specific responses and response rates, see Table 1. Younger psychiatrists were more likely to respond to this item than older psychiatrists (c2 = 4.5, df 1, P = 0.034). There was no sex effect, nor was there any interaction between age and sex on response rates. Among younger respondents, 73.1% reported routinely documenting consent, compared with 49.3% of older respondents. The cumulative odds of reporting more documentation, compared with reporting less documentation, were statistically greater for younger psychiatrists than for older ones (OR 2.87; 95%CI, 1.85 to 4.45). There was no sex difference in reported documentation odds, nor was there an interaction between sex and age. According to bivariate analyses, reported documentation correlated with a positive attitude toward consent documentation (r = –0.493, n = 355, P < 0.001), with more self-reported general disclosure (r = 0.321, n = 356, P < 0.001), and with more specific TD disclosure (r = 0.199, n = 310, P < 0.001). Reported consent documentation did not correlate significantly with reported hours of CME, hours spent reading medical journals, number of patients on antipsychotic medication, reported estimate of the prevalence of TD in patients on antipsychotic medication, or attitudes to signed consent. In the final ordinal logistic regression model (with documentation behaviour as the outcome and variables correlated with documentation behaviour as potential predictor variables), the cumulative odds of reporting more documentation, compared with less documentation, was associated with age (for younger physicians compared with older ones, OR 3.33; 95%CI, 2.07 to 5.34), mean disclosure score (for every unit increase in mean disclosure, OR 2.17; 95%CI, 1.45 to 3.23), and attitude to documentation of informed consent in the chart (for favouring chart documentation compared with being neutral or disagreeing, OR 5.46; 95%CI, 3.24 to 9.28). There was no significant sex effect on the cumulative OR for reported documentation in the chart, nor was there an interaction between sex and age. After controlling for age and sex, specific TD disclosure was not associated with reporting documentation behaviour. Most respondents (90.5%, n = 321) never or almost never reported obtaining written consent from competent patients, 4.8% (n = 17) routinely (always or almost always) used written consent forms, and another 4.8% (n = 17) sometimes used written consent forms. (For stratum-specific responses and response rates, see Table 1.) More younger physicians than older ones responded to this item (c2 = 5.06, df 1, P = 0.025); neither sex nor the interaction between sex and age influenced response rates. The cumulative odds of using written consent, compared with not using it, were not affected by age, sex, or their interaction. Our analysis of psychiatrists’ attitudes toward documentation of the consent process revealed that 77.7% (n = 331) believed the informed consent process should be recorded; 5.4% (n = 23) disagreed. Most respondents (61.2%, n = 259) agreed with the statement that signed consent forms were not necessary, 11.3% (n = 48) disagreed, and 27.4% (n = 116) were neutral. Table 2 shows the stratum-specific responses and response rates. Using ordinal logistic regressions, we observed no evidence that respondents and nonrespondents to the items regarding documentation behaviour and use of written consent forms differed in their attitudes to documentation behaviour or to signed consent forms.
DiscussionAt the time of this study, 63% of psychiatrists surveyed reported routinely documenting consent, and 10% reported rarely documenting the consent process. This reported rate of documenting consent is similar to the 64% reported by pediatricians and neurologists (24). We found that younger physicians were more likely than older physicians to report documenting the consent process and to respond to items on documentation behaviour and TD disclosure. A study of psychiatrists’ medical decision-making practices regarding antipsychotic medication use for schizophrenia also observed an age effect, with older physicians being more likely to prescribe classic antipsychotic medications than younger physicians and with sex not influencing behaviour (25). The current study findings support an effect of age but not of sex on psychiatrists’ behaviours. If reported documentation rates overestimate documentation, actual documentation may be even lower than reported here. For example, in an earlier study using the same self-reported questions regarding documentation, the documentation rates (where consent was obtained from the patient) were 32% among physicians reporting they always or almost always documented consent, 28% among those who reported sometimes documenting consent, and 7% among those who reported never or almost never documenting it (20). Since many patients do not always recall the informed consent process, we remind psychiatrists to document it in the medical record. Self-reported documentation correlated with a positive attitude to documentation; similar findings exist for informed consent disclosure behaviour and attitudes (11). Self-reported documentation also correlated with more self-reported disclosure about the benefits and risks of antipsychotic medications. Although specific disclosure about the risk of TD correlated with self-reported documentation in the bivariate analyses, this association did not remain when we undertook multivariate analyses. We found that neither CME nor reading medical journals correlated with self-reported documentation, in contrast with earlier findings where actual chart documentation correlated significantly with reading medical journals (20). The finding of no association between documentation and either CME or reading medical journals likely reflects the fact that these activities do not necessarily cover issues related to consent and its documentation. In terms of how consent should be documented, few respondents in our sample favoured signed consent forms, a finding similar to the APA survey results and to findings in a smaller sample of psychiatrists (16,20). Several strategies may facilitate documentation, including checklists, standardized disclosures, structured instruments, computerized reminders, computer templates, and chart reviews (18,26–29). A simple checklist or standardized patient disclosure form with a section for patient-specific information may assist notation of the information disclosed to patients as part of the consent process (18). In a US state with guidelines for documenting consent for psychotropic medication, one setting introduced a checklist for use with a narrative comment. Although 88% of the checklists were completed, fewer narratives were recorded, and only 39% were judged acceptable (18). A structured instrument like the MacArthur Competence Assessment Tool–Treatment may help the consent process and its documentation, assuring that essential elements are covered (26). Colourful computerized reminders to physicians to complete an assessment for EPSEs and to record informed consent increased consent documentation rates from 38% to 74% over a 15-month period, and to almost 100% after 45 months (27). Personal digital assistants facilitated documentation in consultation psychiatry (28); their use could be expanded to include sections on consent documentation. This feature would remind the clinician to disclose and aid documentation. Reviews of health records by quality improvement teams have improved general health record documentation (29); perhaps physicians could periodically review their records. In summary, our study found differences between younger and older psychiatrists in their response behaviours and reported behaviours, although we found few differences between the sexes. One limitation is that the study relies on self-reported data rather than on actual chart validation. Although the instrument was validated, our pilot study also found that respondents overestimated their documentation behaviour (20). As such, the reported rates here may overestimate reported documentation behaviour. A second limitation relates to possible response bias linked to the 72% response rate and the observation that younger physicians were more likely to participate in the survey and complete individual items than were older physicians. Although there was no difference in attitudes between responders and nonresponders to documentation behaviour items, the possibility of a response bias may limit the generalizability of the results. Another limitation is that this study was conducted before the widespread use of atypical antipsychotic medications. At the time, however, it was unknown that atypical antipsychotics would be associated with a reduced risk of TD, and this should not have influenced disclosure or documentation. During the conventional antipsychotic era, informing patients about TD and recording consent in the health record had been recommended. Finally, it is unclear whether the prescribing practices and responses to questionnaires of many of the younger psychiatrists who participated in this survey have remained stable as they have aged. As such, current documentation rates may differ from those reported here. Although less has been written about informed consent (and its documentation) for treatment with atypical antipsychotic medications, we recommend that physicians inform patients about these medications so that patients can make autonomous health care decisions and that physicians document the informed consent process in the health record. Although there has been considerable discussion and empirical examination of psychiatrists’ attitudes about disclosing potential TD to patients, relatively little is known about how comfortable psychiatrists are with disclosing information about atypical antipsychotic medications. Further, little is known about patients’ perspectives on the informed consent process. In addition to considering physicians’ perspectives, future studies should expand on this research and consider the perspectives of patients, their families, legal experts, and ethicists. Although signed consent forms are not routinely used for medication prescriptions and were not favoured by the psychiatrists we surveyed, there may be unique situations in psychiatry where signed consent forms may be useful, for example, when prescribing medications for pregnant women (30). However, signing a consent form should not be a substitute for a careful, informed consent process and discussion (30). In many treatment facilities, patients are now signing patient treatment plans as part of their ongoing involvement in their care. Even though signed consent forms or treatment plans indicate that patients have participated in a consent process or treatment plan, they should not take the place of a thorough informed consent process. Further, if the consent form cannot be comprehended, it may suggest that the information necessary for consent has not been adequately conveyed (30). As more hospital-based physicians become involved with patients in the signing of a treatment plan, physicians’ views of signed consent forms may change. It would also be informative to use alternative disclosure and documentation formats to examine patients’ and families’ subjective experiences of the consent process. This evaluation could inform policy-makers and physicians, ultimately leading to an improved informed consent process. ConclusionOne of the major findings of this study was that only 63% of psychiatrists reported routinely documenting the consent process, with younger physicians being more likely to report documenting than older physicians and also being more likely to respond to the survey items. The psychiatrists surveyed did not endorse signed consent forms for the use of antipsychotic medications, a result consistent with the APA position and survey (16). Despite several study limitations, the strengths include a large and representative sample size. Future studies will need to extend this research by examining physicians’ current attitudes and behaviours regarding informed consent, disclosure, and documentation related to the newer atypical antipsychotic medications, as well as by exploring the perspectives of patients, family members, ethicists, and lawyers. Funding and SupportThis study was supported by grants 6606-5304-301 and 6606-4226-57P from the Canadian National Health Research and Development Program. AcknowledgementsThe authors acknowledge the collaboration of Dr Jack Williams on the statistical aspects of this project. References1. Grisso T, Appelbaum PS. Assessing competence to consent to treatment. A guide for physicians and other health professionals. New York (NY): Oxford University Press; 1998. 2. Reibl v Huges. 2 Supreme Court Reports 880 (S. Ct. of Canada 1980). 3. Dickens BM. Informed consent. In: Downie J, Caulfield T, Flood C, editors. Canadian health law and policy, 2nd ed. Markham (ON): Butterworths; 2002. p129–56. 4. Hopp v Lepp. 2 Supreme Court Reports 192 (S. Ct. of Canada 1980). 5. Schachter D, Kleinman I, Prendergast P, Remington G, Schertzer S. The effect of psychopathology on the ability of schizophrenic patients to give informed consent. J Nerv Ment Dis 1994;182:360–2. 6. Grisso T, Appelbaum PS. The MacArthur Treatment Competence Study. III. Abilities of patients to consent to psychiatric and medical treatments. Law Hum Behav 1995;19:149–74. 7. Abidi S, Bhaskara SM. From chlorpromazine to clozapine—antipsychotic adverse effects and the clinician’s dilemma. Can J Psychiatry 2003;48:749–55. 8. Tardive dyskinesia: summary of a Task Force Report of the American Psychiatric Association. Am J Psychiatry 1980;137:1163–72. 9. Kane JM, Smith JM. Tardive dyskinesia: prevalence and risk factors, 1959 to 1979. Arch Gen Psychiatry 1987;39:473–81. 10. Laugharne J, Davies A, Arcelus J, Bouman WP. Informing patients about tardive dyskinesia: a survey of clinicians’ attitudes in three countries. Int J Law Psychiatry 2004;27:101–8. 11. Schachter D, Kleinman I. Psychiatrists’ attitudes about and informed consent practices for antipsychotics and tardive dyskinesia. Psychiatr Serv 2004;55:714–7. 12. Jaffe R. Informed consent: recall about tardive dyskinesia. Compr Psychiatry 1981;22;434–7. 13. Kleinman I, Schachter D, Koritar E. Informed consent and tardive dyskinesia. Am J Psychiatry 1989;146:902–4. 14. Munetz MR, Roth LH. Informing patients about tardive dyskinesia. Arch Gen Psychiatry 1985;42:866–71. 15. Robinson G, Merav A. Informed consent: recall by patients tested postoperatively. Ann Thorac Surg 1976;22:209–12. 16. American Psychiatric Association. Task Force Report 18. Tardive dyskinesia. Washington (DC): American Psychiatric Association; 1979. 17. Sovner R, DiMascio A, Berkowitz D, Randolph P. Tardive dyskinesia and informed consent. Psychosomatics 1978;19:172–7. 18. Munetz MR, Peterson GA. Documenting informed consent for treatment with neuroleptics; an alternative to the consent form. Psychiatr Serv 1996;47:302–3. 19. Lacro JP, Sewell DD, Warren K, Woody S, Harris MJ, Jeste DP. Improving documentation of consent for neuroleptic therapy. Hosp Comm Psychiatry 1994;45:176–8. 20. Schachter D, Kleinman I. Psychiatrists’ documentation of informed consent. Can J Psychiatry 1998;43:1012–7. 21. Cortese L, Jog M, McAuley TJ, Kotteda V, Costa G. Assessing and monitoring antipsychotic-induced movement disorders in hospitalized patients: a cautionary study. Can J Psychiatry 2004;49(1):31–6. 22. Borgiel AEM, Williams JI, Bass MJ, Dunn EV, Evenson MK, Lamont CT, and others. Quality of care in family practice: does residency training make a difference? CMAJ 1989;140:1035–43. 23. Crowne D, Marlowe D. A new scale of social desirability independent of psychopathology. J Consult Psychol 1960;24:349–54. 24. Faden RR, Lewis C, Becker C, Faden AI, Freeman J. Disclosure standards and informed consent. J Health Polit Policy Law 1981;6:255–84. 25. Hamann J, Langer B, Leucht S, Busch R, Kissling W. Medical decision making in antipsychotic drug choice for schizophrenia. Am J Psychiatry 2004;161:1301–4. 26. Grisso T, Appelbaum PS, Hill-Fotouhi C. The MacCAT-T: a clinical tool to assess patients’ capacities to make treatment decisions. Psychiatr Serv 1997;48:1415–9. 27. Hammond KW, Snowden M, Risse SC, Adkins TG, O’Brien JJ. An effective computer-based tardive dyskinesia monitoring system. Am J Med Quality 1995;10:133–7. 28. Luo J, Hales RE, Servis H, Gill M. Clinical computing: use of personal digital assistants in consultation psychiatry. Psychiatr Serv 2002;53:271–9. 29. Baker JG, Shanfield SB, Schnee S. Using quality improvement teams to improve documentation in records at a community mental health center. Psychiatr Serv 2000;51:239–42. 30. Wisner KL, Zarin DA, Holmboe ES, Appelbaum PS, Gelenberg AJ, Leonard HL, and others. Risk-benefit decision making for treatment of depression during pregnancy. Am J Psychiatry 2000;157:1933–40. Author(s)Manuscript received August 2005, revised, and accepted February 2006. 1. Psychiatrist, Child, Youth and Family Program, Centre for Addiction and Mental Health, Toronto, Ontario; Assistant Professor, Department of Psychiatry and Public Health Sciences, University of Toronto, Toronto, Ontario; Member, Joint Centre for Bioethics, University of Toronto, Toronto, Ontario. 2. Psychiatrist, Mount Sinai Hospital and Centre for Addiction and Mental Health; Assistant Professor, Department of Psychiatry and Family and Community Medicine, University of Toronto; Member, Joint Centre for Bioethics, University of Toronto, Toronto, Ontario. Address for correspondence: Dr D Schachter, 250 College Street, Toronto ON M5T 1R8 e-mail: Debbie_Schachter@camh.net
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