Decisional capacity and consent for schizophrenia research.
Schizophrenia (Care and treatment)
Kaup, Allison R.
Dunn, Laura B.
Saks, Elyn R.
Jeste, Dilip V.
Palmer, Barton W.
|Publication:||Name: IRB: Ethics & Human Research Publisher: Hastings Center Audience: Academic Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2011 Hastings Center ISSN: 0193-7758|
|Issue:||Date: July-August, 2011 Source Volume: 33 Source Issue: 4|
|Topic:||Event Code: 310 Science & research|
|Geographic:||Geographic Scope: United States Geographic Code: 1USA United States|
Concerns about the capacity of people with schizophrenia to provide
informed consent to participate in research stem, in part, from worries
that the associated cognitive deficits and/or psychotic symptoms of the
disorder--delusions, hallucinations, and thought disorder, for
example--could impair the abilities needed to make informed decisions,
as well as from the supposition that persons in this population may be
susceptible to coercion. (1) Nonetheless, there is heterogeneity
regarding decisional capacity even within this diagnostic group. (2)
Thus, judgments about an individual's decisional capacity cannot
and should not be based solely on his or her diagnosis. (3)
A wealth of empirical data indicates that severity of cognitive deficits--and, to a lesser degree, negative symptoms--are the strongest predictors of impaired decisional capacity in patients with schizophrenia. (4) There has been less empirical focus on the specific nature of difficulties or the errors manifested by prospective participants when decisional capacity is being assessed. Dunn and Jeste reported findings about the content of such errors. (5) They discovered that, relative to healthy comparison participants, those with psychotic disorders had greater difficulty answering questions regarding the requirements of the study and the potential risks and benefits associated with participation.
A potentially useful complement to the data provided by Dunn and Jeste would be information on the form or process of errors, such as distinguishing those due to forgetfulness from those due to psychotic thought processes. Such information could inform compensatory strategies to maximize the effectiveness of consent procedures. These strategies are needed because attempts to improve the consent process have produced mixed results thus far, depending on the approach used and the population studied. (6) Marson et al. have addressed this issue in mild and moderate probable Alzheimer disease by focusing on the nature of errors made by patients during a hypothetical treatment decision. (7) The authors found that individuals in the Alzheimer group were more likely than those in the normal control group to make certain kinds of errors. These errors were primarily due to communication difficulties (e.g., incomprehensible responses, language production problems such as paraphasias), comprehension problems, factual errors, and responding out of context of the task at hand (i.e., the hypothetical treatment decision). To our knowledge, however, there have been no published studies of this type examining the consent-related errors made by individuals with schizophrenia during the consent process in research or treatment contexts.
As a preliminary effort to elucidate the nature of decision-making errors individuals make during the consent process for research, we examined the responses of research participants with schizophrenia or schizoaffective disorder during administration of a structured capacity interview, the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). (8) We expected that individuals would make a variety of errors, reflecting the diffuse and heterogeneous patterns of cognitive impairment that are found in these disorders. (9) However, the specific nature of the errors related to decisional capacity has not been examined in this population; therefore, the current study was designed to be descriptive and exploratory.
* Participants. This study involved 84 individuals with schizophrenia or schizoaffective disorder who participated in a larger longitudinal study of decisional capacity among middle-aged and older persons with a history of psychoses. (10) Their clinical care providers determined whether they met the criteria for schizophrenia or schizoaffective disorder, as described in the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV). (11) Data for these 84 individuals were originally collected as part of a larger study of capacity to consent to research on the short- and long-term side-effects of second generation ("atypical") antipsychotic medications, which also included a smaller number of persons with mood disorders with a history of psychotic features, in addition to the larger schizophrenia sample. All participants in the large study completed the MacCAT-CR (described below). However, as also described below, the current analyses were based on secondary coding of the individual responses on each MacCAT-CR item. Given the lack of prior research focused on the error processes in the MacCAT-CR, we had no basis for conducting an a priori power analysis to determine sample size. Because secondary coding of each participant's MacCATCR was a labor-intensive process, we decided to do the secondary coding for the first 100 consecutive participants from the larger study. For the present report, we decided to exclude 16 individuals who had a diagnosis other than schizophrenia or schizoaffective disorder because the primary question was whether psychotic symptoms affect decisional capacity in patients with a primary psychotic disorder.
The 84 participants had a mean age of 54.1 years (sd = 8.4) and education of 12.2 years (sd = 2.8); 38.1% were women and 64.3% were Caucasian. Many (54.8%) were living in board and care facilities; 31% were in apartments/ houses, 3.6% were in assisted living facilities, 2.4% were in single room occupancies, and 1.2% were homeless. Participants' psychiatric characteristics were assessed with the Positive and Negative Syndrome Scale (PANSS), (12) the 17-item Hamilton Depression Rating Scale (HAM-D), and the Birchwood Insight Questionnaire. (13) Participants' mean symptom levels were as follows: schizophrenia positive symptom severity (PANSS Positive Total) equaled 15.2 (sd = 5.9, range = 7-30), schizophrenia negative symptom severity (PANSS Negative Total) equaled 13.1 (sd = 5.4, range = 7-32), depression severity (HAMD) equaled 9.4 (sd = 5.8, range = 0-28), and insight (Birchwood Insight Total) equaled 8.3 (sd = 3.0, range = 0-12). Participants were clinically stable outpatients, and these inventories indicate that most individuals' psychiatric symptoms were mild in severity.
The consent process for this study of informed consent involved a member of our research staff meeting with each prospective participant, reviewing the consent form with him or her, and answering any questions they had. Because the study met the federal definition of "minimal risk," (14) guidance from our institutional review board (IRB) indicated that formal assessment of capacity to consent was not required to enroll participants in the study. Further, because of the minimal-risk nature of this study, a lower level of comprehension ability was needed than might be the case for the typically more complex and risky randomized clinical drug trial. (15) However, our staff is trained to be attuned to apparent confusion individuals might exhibit during the consent process, and two potential participants were excluded from the study due to a clear lack of understanding regarding the nature of the project. No individuals were enrolled as a result of proxy consent by an authorized third party. However, two participants who provided first-person consent also had legal conservators who gave permission for them to participate in the study. All participants provided written consent to participate.
* Procedures. Participants completed the MacCAT-CR, a semi-structured interview that assesses their: 1) understanding of disclosed information, 2) appreciation of the information in terms of one's personal situation, 3) reasoning with the information, and 4) expression of a choice. The MacCAT-CR items were tailored in reference to a naturalistic study of the short- and long-term side effects of antipsychotic medications in which individuals were actually considering enrolling. (16) This naturalistic study would involve cognitive, motor, and symptom assessments, and participants' medications would not be changed.
The MacCAT-CR is a 20-30 minute semistructured interview. The MacCAT-CR interviews for this study were conducted by trained bachelor's-level research assistants under the supervision of two of the study authors (BWP and LBD). As per standard MacCAT-CR administration, interviewers were trained to ask follow-up questions so that respondents could clarify any ambiguous responses. Also, information provided during the Understanding subscale was explained again if a participant's initial response indicated that he or she did not fully comprehend the information. The standard MacCAT-CR administration includes one such second explanation and query per item, but as one of the goals of the overall study was to evaluate the value of further explanation, we permitted up to two further explanations. (17) Interviewers were instructed to record responses to each item verbatim, to the extent possible, without disrupting the flow of the interview. These recorded responses served as the key data for the present error analyses.
Respondents were referred on to the study described by the MacCATCR if they expressed interest in enrolling in that study and they were considered to have adequate decisional capacity to provide informed consent to that study. Specifically, if a respondent's total Understanding score was less than or equal to 15 by trial three, they were considered to have inadequate decisional capacity for participation in that study. Furthermore, in order to be referred on to the study, a respondent had to give the correct answer to three critical items on the MacCAT-CR regarding 1) the potential risks of the study, 2) the right to withdraw, and 3) the voluntary nature of the study. For those who exceeded these requirements, clinical judgment was also used to evaluate whether they had adequate decisional capacity to consent to that study.
* Data Analysis. Three of the authors (ARK, BWP, and LBD), blind to participants' MacCATCR quantitative scores, examined participants' responses on the MacCAT-CR using a coding scheme developed for these purposes. Steps used in the coding scheme development process are outlined in Figure 1. Additional details about this process and specific scoring criteria are available from the authors upon request. Raters individually examined and coded each MacCATCR protocol using the final version of the coding scheme. Table 1 lists the interrater agreement rates for each code that resulted from this step. After completing step one, raters met to discuss their ratings of each participant's responses on the MacCAT-CR and to generate final codes as agreed upon via group consensus. Any coding discrepancies were discussed, and agreement on all of the codes was reached, such that no codes remained disputed. All remaining analyses reflect these consensus codes.
[FIGURE 1 OMITTED]
Error categories for the MacCAT-CR Understanding subscale included 1) difficulty recalling the disclosed study information, 2) perseveration (i.e., the pathological, persistent repetition of a word, phrase, or idea), 3 ) illogical responses, 4) psychosis or delusions apparent in responses, and 5) overly concrete and/or personalized responses (i.e., overly emphasizing the potential for gain from study participation). For respondents who were coded as having difficulty recalling study information, we noted whether their performance improved following repetition of the information. Error categories for the Appreciation subscale included 1) difficulty appreciating the goals of the study (i.e., distinguishing research goals from personal benefit) and 2) difficulty appreciating the study procedures (i.e., recognition that assessments were for study purposes, not clinical care). Error categories for the Reasoning subscale included reasoning that was considered 1) vague, 2) illogical, 3) limited (e.g., only one reason for choice given when two are required per standard MacCAT-CR scoring criteria), or 4) inconsistent (i.e., reasoning did not correspond with final choice). On the Expression of a Choice subscale, we noted whether respondents clearly expressed a choice. As this is what determines the quantitative score on this subscale, separate coding of this item was not required.
The frequencies of all codes described above were tallied. For respondents coded as having difficulty recalling information on the Understanding subscale, specific items for which they struggled to recall information were recorded. Given concern regarding the potential for coercion in this population, we also recorded the number of participants who correctly recognized that study participation would be voluntary.
With regard to frequency of error categories, 70 out of 84 participants (83.3%) demonstrated at least one error on the MacCATCR. Most of the errors occurred on the Understanding subscale. Table 2 shows the frequency of each error. The most common source of errors, seen in 55 of the 84 participants, was difficulty recalling study information. Table 3 lists the specific information that these 55 participants had difficulty recalling. Of this group, with repetition of relevant information, 36.4% showed perfect or near-perfect recall, 47.3% recalled more information but continued to miss important details, and 16.4% showed no recall improvement.
Regarding voluntariness in research, after the first presentation of the study information, 76 out of 84 participants (90.5%) indicated they were aware there would be no negative consequences for them if they chose not to participate. Only one participant failed to demonstrate this knowledge following repetition of the disclosed study information.
The majority of participants in our study (83.3%) demonstrated at least one error during the interview regarding decisional capacity to participate in research as measured by the MacCAT-CR. The most common source of errors by far was difficulty recalling aspects of the study information disclosed during the Understanding subscale (65.5% of participants). Eyler and colleagues provide further evidence of the importance of memory processes and/or systems in decisional capacity among schizophrenia patients. (18) Using functional magnetic resonance imaging, these authors found that performance on the MacCAT-CR Understanding subscale was correlated with brain activation during a verbal learning task in regions known to support learning and memory including the right hippocampus and the bilateral parahippocampus.
Together, these findings suggest that efforts to enhance the research consent process for individuals with schizophrenia and schizoaffective disorder should focus on factors that facilitate initial acquisition and processing of the disclosed information. Indeed, in our study participants struggled to recall even the most basic points of the study information (e.g., 42.9% had difficulty recalling the purpose of the study). It may be that the large amount of detailed information provided during consent procedures, in combination with impaired memory abilities, makes it difficult for individuals with schizophrenia and schizoaffective disorder to learn and retain the key points. Our findings do suggest, however, that repetition of the study information ameliorates recall errors in most cases. Together, these findings highlight the importance of structuring the disclosed study information in such a way as to emphasize key points and repeating the information in order to facilitate recall.
Participants' responses were also notable for the errors they did not make. Ethical concerns have been raised surrounding the notion that psychotic symptoms per se (e.g., delusional thinking) might impede the capacity for decision-making. However, in the present analyses, no evidence supports detrimental effects of psychosis on decisional capacity for research participation among this outpatient sample. These findings complement quantitative studies that found no relationship between decisional capacity for research participation and the positive symptoms of schizophrenia in samples of both outpatients and inpatients. (19) However, some quantitative studies have found a negative relationship between positive symptoms and decisional capacity, including studies of inpatient participants involving decisional capacity to participate in research (20) and to undergo treatment. (21) On average, individuals in our sample were rated as having mild psychiatric symptoms, although some did have moderate symptoms. On the PANSS, 28% of the sample was rated as having delusional symptoms of at least moderate severity, and 35.4% of the sample was rated as having hallucinatory symptoms of at least moderate severity. Thus, despite psychotic symptoms of this severity being present among our sample, they were not evident during participants' responses on the MacCAT-CR, suggesting that these symptoms did not affect decisional capacity. Nevertheless, conclusions regarding the impact (or lack thereof) of psychotic symptoms on decisional capacity must be tempered, as our sample consisted primarily of clinically stable outpatients. A limitation of the present study is that results cannot be generalized to more acutely ill or inpatient populations. Future research should explore whether inpatients exhibit a different pattern of errors related to decisional capacity.
Despite concerns regarding the potential for coercion, the fact that the vast majority of participants in the present study recognized the voluntary nature of participation suggests that perceived coercion is uncommon. Minimal previous work has examined the possibility of coercion in research enrollment in mentally ill populations. Moser and colleagues assessed susceptibility to coercion in the research context among 30 incarcerated mentally ill people (of whom five had schizophrenia or schizophrenia-related disorders). Although individuals with worse neuropsychological functioning showed higher susceptibility to coercion, no evidence of actual coercion was found. (22) Despite these null findings, there remains the possibility of undue influence and therapeutic misconception, of which one aspect may be conflating the role of the clinician and researcher--particularly if that happens to be the same individual. (23)
In the present analyses, participants were observed as making more errors during the Understanding subscale than during the remaining MacCAT-CR subscales. This finding may be counterintuitive in that adequate appreciation and reasoning abilities would logically seem to be dependent upon good understanding of the study information. However, we suspect that this finding is an artifact driven by the nature of the MacCAT-CR, whose Appreciation and Reasoning subscales contain far fewer items than the Understanding subscale. Thus, those subscales are likely less sensitive in eliciting patient error.
In interpreting our results, it is important to remember that participants' incorrect responses were classified according to the apparent source of the error and that we cannot be certain of the true source of the error. For example, errors classified as "difficulty recalling" could be due to difficulty encoding, storing, or retrieving the information. Alternatively, this type of error may have resulted from a number of other intrapersonal or contextual factors. (24) Personal limitations such as poor attention, low motivation, or fatigue may have affected an individual's responses, along with situational demands--being presented information that was too complex, for example, or being presented information in a manner not conducive to recall. Furthermore, deficits in pragmatic or social communication (25) may have contributed to difficulties understanding the questioners' intent or responding appropriately.
It is also important to recognize that in the context of the present study, decisional capacity was assessed in reference to consent for an outpatient naturalistic study of the short- and long-term side effects of antipsychotic medications approved by the Food and Drug Administration (FDA). Contrast this context with that of a placebo-controlled clinical trial in an acute inpatient psychiatric setting, and/or in the context of capacity to competently refuse treatment among acutely psychotic persons (e.g., refusal of hospitalization or medication). Clearly, the association between capacity and psychopathology may differ across these different contexts. Moreover, the considerations of respect for autonomy versus protection of those with diminished capacity for authentic autonomous decision-making may be more complex, or at minimum, distinct. Thus, the types of errors and the source of errors seen in the present sample may not readily generalize (either in terms of statistical association or ethical implications) to distinctly different contexts.
This study has additional limitations. As the protocol was not originally designed for a qualitative examination of the data, some errors may reflect interviewer (rather than patient) error--e.g., failing to record a participant's response verbatim. The way we evaluated the MacCAT-CRs also introduced limitations. First, a degree of subjectivity is inherent in how raters classified responses, which likely impacted the initial interrater agreement rates (Table 1) prior to the final codes being determined by group consensus. Subjectivity may affect interrater reliability, (26) which itself puts an upper limit on validity. (27) However, common procedures to improve apparent objectivity (such as more structured response formats) do not necessarily improve reliability, (28) and even perfectly reliable measures may lack validity. (29) The bottom line is that the ideal (most reliable and valid) method of classifying respondent errors during capacity assessment is not presently known. The present study illustrates one potential approach, but additional research on error types would be useful in developing and evaluating other potential methods that could be more routinely applied in determining where participants in a given study or population are most likely to have difficulty with routine consent procedures. Another limitation is that some MacCAT-CRs were evaluated more than once during the coding scheme development process in order to refine our coding methods. Also, although we feel that our group decisions represent a more accurate depiction of participants' responses, rating each MacCAT-CR via group consensus limited individual raters' independence. Finally, there are several known limitations to the MacCAT-CR measure itself, (30) limiting, to some degree, the validity of our codes. As mentioned above, the Appreciation and Reasoning subscales contain few items, constraining the amount of information that was elicited from participants and making comprehensive evaluation of their appreciation and reasoning abilities difficult.
Nevertheless, these results inform ways to improve consent procedures to increase the likelihood that individuals with schizophrenia are making informed decisions regarding research participation. Given difficulties some individuals have with recalling information conveyed during the consent process, key study information should be highlighted and repeated to them during this process, while some information may require less explanation. For example, in the present sample, the vast majority of participants recognized that participating in a study is voluntary, but a significant proportion had difficulty recalling the purpose of the study. This suggests that spending a great amount of time covering voluntariness is unnecessary, while additional explanation of other key points is warranted.
The finding that some participants provided rationales for participation that were considered overly vague or otherwise limited in content suggests that some had difficulty verbalizing their reasons. Alternatively, such lack of clear response may be due to limitations in the Reasoning subscale. As probing may be required to obtain adequate information from individuals about their decision-making process and reasons, consent procedures should include an interactive discussion of reasons for and against participation. This would have the additional salutary effect of providing researchers the opportunity to clarify or explain again aspects of the study if individuals' reasoning seems faulty or vague.
Researchers should be aware that potential participants might confuse the goals and purposes of research with those of clinical care. (31) In the present study, some participants did have difficulty appreciating the differences between the two or overemphasized how being in the study might benefit them personally. However, they were being asked to consider consenting to a minimal-risk study that could actually have some benefit for them (e.g., they would receive comprehensive evaluations), so therapeutic misconception is not as concerning in this situation. Future studies should continue to evaluate the nature and prevalence of therapeutic misconception in higher-risk studies, like randomized, placebo-controlled clinical trials. Qualitative analysis of individuals' responses to an assessment of decisional capacity within such contexts could elucidate points of confusion and suggest ways to improve consent procedures to reduce therapeutic misconception. For all studies--but for higher-risk protocols in particular--consent procedures should emphasize the differences between research and clinical care. Again, an interactive discussion would help the researcher to understand individuals' beliefs and to address any misconceptions.
Interventions designed to improve decisional capacity have yielded promising, but mixed, results. (32) Consideration of the errors that individuals make during assessment processes, as suggested by the present study, may inform the development of more targeted interventions. Modifications to consent procedures that should be evaluated in future studies include emphasis and repetition of key study information, clarification and emphasis of distinctions between research and clinical care, and expanded discussion and assessment of individuals' abilities to appreciate and reason about the information conveyed to them. Finally, consistent with ethical obligations of researchers to ensure that participants have understood the relevant information, the con sent process should be viewed as both a conversation and an information-sharing process, rather than merely the reading and signing of the consent form. (33)
Knowledge of the types of errors that individuals make during decision-making for research participation may also help IRBs to provide further guidance to researchers regarding the informed consent process. IRBs aptly regulate what study information is disclosed to potential participants but typically give less attention to how that information is conveyed. As described above, our results point out some weaknesses in the informed consent process, at least for this particular population of clinically stable outpatients with schizophrenia, and suggest possible strategies for improvement. IRBs could use this information to encourage researchers to employ more novel and interactive methods of information disclosure.
Funding for this study was provided by the National Institutes of Health/National Institute of Mental Health (R01 MH64722 to BWP, 5P30MH66248-05 to DVJ). We thank Shahrokh Golshan, PhD, for his consultation regarding methodology and data analysis. This study was approved by the University of California, San Diego, and San Diego State University institutional review boards.
* Allison R. Kaup, MS, is a doctoral student at the San Diego State University/University of California, San Diego, Joint Doctoral Program in Clinical Psychology, Department of Psychology, San Diego State University, and Department of Psychiatry, University of California, San Diego, in San Diego, CA; Laura B. Dunn, MD, is Associate Professor, Department of Psychiatry, University of California, San Francisco, in San Francisco, CA; Elyn R. Saks, JD, is Professor, Gould School of Law, University of Southern California, and Department of Psychiatry, University of California, San Diego, in San Diego, CA; Dilip V. Jeste, MD, is Professor, Department of Psychiatry, and Director of the Sam and Rose Stein Institute for Research on Aging, University of California, San Diego, in San Diego, CA; and Barton W. Palmer, PhD, is Professor, Department of Psychiatry, Univer sity of California, San Diego, and Research Scientist at the San Diego Veterans Medical Research Foundation, San Diego, CA.
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(14.) UCSD Human Research Protections Program. UCSD Human Research Protections Program Task Force for Recommending Procedures for Determination of Decisional Capacity in Subjects Participating in Research Protocols. Decision making capacity guidelines, http://irb.ucsd.edu/decisional. shtml; U.S. Department of Health and Human Services. Protection of Human Subjects. 45 CFR 46, http://www.hhs.gov/ohrp/humansubj ects/guidance/4 5cfr46 .html.
(15.) For a detailed discussion of the issue of decisional capacity for research on informed consent, see Saks ER, Dunn LB, Palmer BW. Meta-consent in research on decisional capacity: A "Catch-22"? Schizophrenia Bulletin 2006;32:42-46.
(16.) Dolder CR, Jeste DV. Incidence of tardive dyskinesia with typical versus atypical antipsychotics in very high risk patients. Biological Psychiatry 2003;53:1142-1145.
(17.) See ref. 10, Palmer and Jeste 2006; Palmer et al. 2007.
(18.) Eyler LT, Olsen RK, Nayak GV, et al. Brain response correlates of decisional capacity in schizophrenia: A preliminary FMRI study. Journal of Neuropsychiatry and Clinical Neurosciences 2007;19:137-144.
(19.) See ref. 10, Palmer and Jeste 2006; Stroup S, Appelbaum P, Swartz M, et al. Decision-making capacity for research participation among individuals in the CATIE schizophrenia trial. Schizophrenia Research 2005;80:1-8; Moser D, Schultz S, Arndt S, et al. Capacity to provide informed consent for participation in schizophrenia and HIV research. American Journal of Psychiatry 2002;159:1201-1207.
(20.) Kovnick JA, Appelbaum PS, Hoge SK, et al. Competence to consent to research among long-stay inpatients with chronic schizophrenia. Psychiatric Services 2003;54:1247-1252.
(21.) Wong JGWS, Cheung EPT, Chen EYH. Decision-making capacity of inpatients with schizophrenia in Hong Kong. Journal of Nervous and Mental Disease 2005;193:316-322.
(22.) Moser DJ, Arndt S, Kanz JE, et al. Coercion and informed consent in research involving prisoners. Comprehensive Psychiatry 2004;45:1-9.
(23.) Appelbaum PS, Roth LH, Lidz CW, et al. False hopes and best data: Consent to research and the therapeutic misconception. Hastings Center Report 1987;17:20-25.
(24.) Dunn LB, Palmer BW, Karlawish JHT. Frontal dysfunction and capacity to consent to treatment or research: Conceptual considerations and empirical evidence. In: Miller BL, Cummings JL. Human Frontal Lobes: Functions and Disorders. New York: Guilford Press, 2005, p. 335-344.
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(29.) See ref. 27, Anastasi and Urbina 1997.
(30.) See ref. 2, Dunn 2006.
(31.) Appelbaum PS, Roth LH, Lidz C. The therapeutic misconception: Informed consent in psychiatric research. International Journal of Law and Psychiatry 1982;5:319-329; Henderson GE, Churchill LR, Davis AM, et al. Clinical trials and medical care: Defining the therapeutic misconception. PLoS Medicine 2007;4:1735-1738.
(32.) Dunn LB, Lindamer LA, Palmer BW, et al. Improving understanding of research consent in middle-aged and elderly patients with psychotic disorders. American Journal of Geriatric Psychiatry 2002;10:142-150; Eyler LT, Mirzakhanian H, Jeste DV. A preliminary study of interactive questioning methods to assess and improve understanding of informed consent among patients with schizophrenia. Schizophrenia Research 2005;75:193-198; Moser DR. Using a brief intervention to improve decisional capacity in schizophrenia research. Schizophrenia Bulletin 2006;32:116-120; Palmer BW, Cassidy EL, Dunn LB, et al. Effective use of consent forms and interactive questions in the consent process. IRB: Ethics & Human Research 2008;30:8-12; Jeste DV, Palmer BW, Golshan S, et al. Multimedia consent for research in people with schizophrenia and normal subjects: A randomized controlled trial. Schizophrenia Bulletin 2009;35:719-729.
(33.) See ref. 32, Palmer et al. 2008.
Allison R. Kaup, Laura B. Dunn, Elyn R. Saks, Dilip V. Jeste, and Barton W. Palmer, "Decisional Capacity and Consent for Schizophrenia Research," IRB: Ethics & Human Research 33, no. 4 (2011): 1-9.
Table 1. Initial Agreement among Three Raters for Each Code, Prior to Group Consensus Code Intraclass Correlation Coefficients ICC (95% Confidence interval) Understanding Errors were made 0.83 (0.75-0.88) Difficulty recalling study information 0.61 (0.44-0.73) Overly concrete/personalized responses 0.56 (0.36-0.70) Illogical responses 0.73 (0.62-0.82) Perseverative responding 0.18 (-0.19-0.44) Psychosis/delusions apparent NA Other 0.37 (0.10-0.57) Appreciation Errors were made 0.91 (0.86-0.94) Difficulty appreciating study procedures 0.93 (0.90-0.95) Difficulty appreciating study goals 0.85 (0.78-0.90) Other 0.77 (0.67-0.85) Reasoning Errors were made 0.75 (0.64-0.83) Vague reasoning 0.52 (0.30-0.68) Limited reasoning 0.65 (0.50-0.76) Illogical reasoning 0.57 (0.38-0.71) Inconsistent reasoning 0.49 (0.27-0.65) Other 0.49 (0.28-0.66) Table 2. Frequency of Consensus Codes: Presence of MacCAT-CR Errors and Apparent Sources of Errors Code % of Patients Understanding Errors were made 66.7 Difficulty recalling study information 65.5 Overly concrete/personalized responses 22.6 Illogical responses 11.9 Perseverative responding 1.2 Psychosis/delusions apparent 0.0 Other 8.3 Appreciation Errors were made 46.4 Difficulty appreciating study procedures 27.4 Difficulty appreciating study goals 20.2 Other 13.1 Reasoning Errors were made 42.9 Vague reasoning 23.8 Limited reasoning 21.4 Illogical reasoning 9.5 Inconsistent reasoning 2.4 Other 3.6 Expression of Choice Error was made (i.e., unclear choice) 3.6 Table 3. Content Forgotten by Patients during the MacCAT-CR Understanding Subscale Content % of Patients (of the 55 patients coded as having difficulty recalling study information) Study procedures 64.3 Potential risks/discomforts 52.4 Purpose of the study 42.9 Differences between research study and clinical care 29.8 Potential benefits of study participation (societal and/or personal) 19.0 Voluntary nature of participation 9.5 Note: Percentages reflect performance prior to repetition of disclosed study information. As described in the Results section, most patients showed improvement in recall following repetition.
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