Improving Understanding of Research Consent Disclosures Among Persons With Mental Illness Paul G. Stiles, J.D., Ph.D. Norman G. Poythress, Ph.D. Alicia Hall, M.A. Diana Falkenbach, M.A. Robyn Williams, M.A.
Objective: The objective of this study was to evaluate alternative procedures for improving the understanding of research consent disclosures by persons who have mental illness. Methods: Three groups participated in the study: persons with schizophrenia (N=79), persons with depression (N=82), and a healthy control group (N=80). The participants were guided through an informed consent process in which two factors were manipulated. One was the structure of the disclosure form; either a typical disclosure form involving standard dense text was used, or a graphically enhanced form was used. The other was the interpersonal process: the presence or absence of a third-party facilitator, with iterative feedback given to participants for whom a facilitator was not present. Participants’ understanding of the disclosure was assessed with the use of recall tests that involved paraphrasing and recognition tests that involved multiple choice. Results: The mean understanding scores did not differ significantly between the depression and control groups, and the mean scores of the schizophrenia group were significantly lower than those of the other two groups. Neither the graphically enhanced consent disclosure form nor the presence of a third-party facilitator was associated with improved understanding. The use of iterative feedback was associated with improvement in comprehension scores in all groups. Conclusions: The use of a feedback procedure in the consent disclosure process during the recruitment of persons who are mentally ill may be a valuable safeguard for ensuring adequate understanding and appropriate participation in research. (Psychiatric Services 52: 780–785, 2001)
P
sychiatric patients may experience a variety of symptoms that impair their capacity to comprehend informed consent disclosures for research studies. The National Bioethics Advisory Commission has noted (1) that although “the mere diagnosis of a mental disorder does not imply a lack of decision mak-
ing capacity,” it is widely acknowledged that “persons with fluctuating and/or limited capacity present serious problems of assessment.” The inappropriate inclusion in research studies of individuals who are incompetent to make decisions about participation may expose these persons to unwarranted risks; conversely, the
The authors are affiliated with the department of mental health law and policy at the Louis de la Parte Florida Mental Health Institute of the University of South Florida, 13301 Bruce B. Downs Boulevard, Tampa, Florida 33612 (e-mail,
[email protected]). 780
inappropriate exclusion of competent and willing individuals affronts individual dignity and autonomy and may bias research results (2). To minimize these risks, it is important that procedures be developed that accurately and optimally assess the comprehension of research consent disclosures by potential research participants. In this study we evaluated several procedures designed to enhance the understanding by mentally ill persons of research consent disclosures. Several writers have suggested that a third party, described in the literature as a consent auditor (3), a neutral educator (4), or a research intermediary (5), be involved as a means of facilitating prospective participants’ understanding of consent disclosures. Although the concept of a facilitator appears to have some promise, little empirical work has been done to define the facilitator’s role or to determine what methods are successful in enhancing comprehension. Ample research has shown that consent disclosures that require unrealistically high reading levels (6–9) or that contain excessive clinical jargon (10) are more difficult to comprehend than more simple disclosures. Other studies have suggested that the graphic layout of the disclosure form may influence comprehension (11). For example, comprehension may be improved by the use of full sentences—such as “You do not have to take part in this study if you do not want to”— that identify a paragraph’s
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key point, rather than simple topical headings such as “Voluntary Participation.” Comprehension could also be improved by the use of bullet formatting that highlights important information that is usually buried in narrative text. Another potentially important contextual variable is the task used to evaluate understanding. Although most investigators have used recall measures—for example, paraphrasing—to assess understanding, an alternative is to use objective measures, such as multiple-choice or true-false tests. Informed consent studies among elderly persons (12) and studies of mentally ill persons in the contexts of treatment decision making (13) and voluntary hospitalization (14) showed that comprehension was better when objective measures rather than recall measures were used. Roth and Appelbaum (15) argued that “consent should be regarded not as an event but as a process,” and that “sustained efforts should be made to inform subjects before concluding that they cannot understand. . . .” Subsequent studies among elderly persons (16,17) and people with schizophrenia (18,19) or depression (20) have shown that for many patients, corrective feedback or educational interventions may be effective in ameliorating initial difficulties in understanding consent disclosures. In this hypothetical clinical trial we manipulated two aspects of the informed consent process: the structure of the consent form—typical versus graphically enhanced—and the presence or absence of a third-party facilitator. Each participant’s understanding of a consent disclosure for a hypothetical medication trial was tested with use of both recall and recognition tests. For participants who were not exposed to a facilitator during the informed consent process, we also evaluated the impact of iterative feedback on the ultimate recognition score. The participants were people who were receiving treatment for schizophrenia or depression and a healthy control group who were randomly assigned to experimental conditions. Against null hypotheses of no differences among diagnostic groups or experimental manipulations, our experPSYCHIATRIC SERVICES
imental hypotheses were that scores on understanding would be lower in the group with schizophrenia than in the other two groups; that scores on understanding would be higher among participants who received the graphically enhanced consent form; that scores on understanding would be higher when the consent process was mediated by a third-party facilitator; that scores on understanding would be higher for recognition than for re-
The inappropriate inclusion in research studies of individuals who are incompetent to make decisions about participation may expose these persons to unwarranted risks;conversely, the inappropriate exclusion of competent and willing individuals affronts individual dignity and autonomy and may bias research results.
call tests; and that iterative feedback would improve the participants’ understanding of consent disclosures.
Methods Participants
A total of 241 adults aged 18 years or older participated in the study, which took place during 1997 and 1998. The clinical participants—that is, those
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who had either schizophrenia (N=79) or depression (N=82)—were recruited from mental health treatment facilities in west central Florida. The control group comprised 80 persons from a local jury venire who were awaiting the call to jury duty. All participants were compensated $10 for their time. Stimulus materials
Two versions of the consent disclosure were used. The model for the typical consent form was a consent form from an actual medication trial that was obtained from the archives of the institutional review board of the University of South Florida. The typical form had discrete headings, such as “Purpose of the Study,” to identify discrete issues. Information about each issue was presented in paragraph format. In contrast, the graphic version contained presentational enhancements that were recommended by a focus group of mental health care consumers, who reviewed sample disclosures that displayed a variety of possible graphic features—for example, different fonts and the use of bold or italic type—that could be used to emphasize important information. A fictitious drug name—petrinone—was inserted in place of the original drug name, and, for each group, typical and graphic versions described petrinone as an experimental drug for the treatment of the relevant disorder. For the control group, heart disease was listed as the disorder being treated because it was considered to be a plausible disorder to which control participants could relate. The consent forms were otherwise identical in content. Measures
Demographic and clinical measures. A brief questionnaire was used to elicit self-reported demographic information. Clinical measures included the Brief Psychiatric Rating Scale–Anchored Version (BPRS-A) (21) and the Mini Mental Status Examination (MMSE) (22). The BPRSA provides a global index of the severity of current psychopathology on the basis of clinical ratings, on a scale from 1 to 7, of 18 psychiatric symptoms on the basis of a brief interview. 781
Table 1
Characteristics of 227 participants in a study on understanding of research consent disclosures Depression group (N=76) Characteristic Race or ethnicity1 Caucasian African American Native American Other Hispanic Sex Male Female Scores on clinical scales Mini Mental Status Examination2 Brief Psychiatric Rating Scale–Anchored Version3 1 2 3
Schizophrenia group (N=77)
Control group (N=74)
N or mean
N or mean
%
N or mean
%
%
62 7 3 4 8
82 9 4 5 11
47 27 3 3 11
61 35 4 4 14
60 10 1
81 14 1
7
9
46 30
61 39
53 24
69 31
45 29
61 39
27.84±2.03
25.99±4
28.14±4.19
30.67±6.26
31.31±8.6
20.73±3.64
Ns total more than 76 because some participants who identified themselves as Hispanic also identified themselves as belonging to one of the other categories. Possible scores range from 0 to 30, with higher scores indicating better functioning. Possible scores range from 18 to 126, with higher scores indicating greater severity.
Possible scores thus range from 18 to 126, with higher scores indicating greater severity. The MMSE is a brief screening measure that evaluates areas of cognitive functioning, such as attention and memory. Scores on the MMSE range from 0 to 30, with higher scores indicating better functioning; a cutoff score of 24 is recommended for identifying cognitively impaired individuals. Measures of understanding. Recall and recognition tests were constructed to test participants’ understanding of the consent disclosure. The recall test contained open-ended questions that required a paraphrased response, and the recognition test used a multiple-choice format. Each test had a range of possible scores from 0 to 15, with higher scores indicating better understanding, and each tested for the same 15 elements. Procedures
Clinical staff at participating treatment facilities identified potentially eligible participants—that is, those who met age and diagnostic inclusion criteria and who did not pose a threat to the trained research assistants who were to administer the protocol. Participants were self-identified; they 782
volunteered in response to an announcement through the public address system. Informed consent was obtained from each participant according to procedures approved by the institutional review board of the University of South Florida. Participants in each group were randomly assigned to receive either a standard consent process with feedback or a facilitated consent process and, within those conditions, either the typical or the graphic version of the consent form. Each participant completed the demographic questionnaire first. The consent disclosure and the tests of understanding were then presented—recall followed by recognition. Finally, the MMSE and the BPRS-A were administered. For the participants who were exposed to the standard consent process with feedback, the research assistant assumed the role of the petrinone investigator, gave the participant a copy of the consent disclosure, and told the participant to follow along while the consent form was read aloud. The research assistant then encouraged the participant to ask questions or seek clarification of material that was not understood. The recall test was then administered, followed by the recognition test.
Any participant who did not attain a perfect score on the recognition test received feedback and was retested. The research assistant identified any sections of the consent form that contained information that the participant had not adequately understood. The research assistant then reread these areas of the form to the participant and retested the participant by using the entire recognition test. Two iterations of feedback and retesting were permitted, although a second iteration was not executed if the participant attained a perfect score after one iteration. For participants who were exposed to the facilitated condition, one research assistant recruited the participant into the study and then left the room. Two other research assistants— assuming the roles of facilitator and petrinone investigator—entered the room to administer the consent disclosure. The same research assistant served as facilitator for all participants in the facilitated condition. The facilitator introduced herself to the participant and the “investigator” and explained that her role was to help the participant understand the consent form. The consent form presented information in 13 discrete sections, including purpose, description, possible benefits, potential risks, and confidentiality. The facilitator used several strategies, developed in consultation with a mediation expert, in an effort to maximize participants’ understanding. These strategies included interrupting the reading of the consent disclosure at the end of each section to ask the participant to state the main points of the section, to ask whether the participant had any questions about that section, and to urge the participant to seek clarification at that time rather than wait until the disclosure had been read in its entirety. When the consent disclosure was completed, the recall test of understanding was administered, followed by a single administration of the recognition test. Statistical analyses
Before the statistical analyses were conducted, participants’ scores on the MMSE and the BPRS-A were examined. Ten participants who had either schizophrenia or depression and
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whose MMSE scores were below the recommended cutoff of 24 were excluded from the analyses to reduce the effect of cognitive impairment on the results. Thus we were able to focus on the effect of other factors on dependent measures of understanding. Four participants in the control group whose BPRS-A scores were more than two standard deviations below the group mean were excluded to maximize the likelihood that the control group did not include individuals with acute psychiatric conditions. Thus a total of 227 participants were included in the analysis. Independent variables included whether the participant was in the schizophrenia, depression, or control group; whether the typical or graphic version of the consent form was used; and whether the participant was exposed to the standard consent process with feedback or to the facilitated consent process. Dependent variables were scores on the recall and recognition tests. Thus the study used a 3 × 2 × 2 design—three diagnoses, two forms, and two processes—with two dependent variables. Analyses were conducted with SPSS, version 9.0.
Results The overall research sample was predominately male (135 participants, or 59 percent) and Caucasian (178 participants, or 78 percent). Clinical and demographic information for the participants who were included in the analyses is presented by diagnostic group in Table 1. The distribution of Caucasian and African-American subjects differed across groups (χ2=17.7, df=2, 211 p
