Participation in randomised controlled trials: perspectives of psychiatric patients and key relatives

Abstract

This study assessed the perspectives of adults who had acute nonorganic psychiatric disorders and were admitted in a private, not for- profit medical college hospital, and also of their key relatives, on randomised controlled trials (RCTs). Structured questionnaires and audio-recorded interviews were used for the purpose. We explored their willingness and motivation to participate in two hypothetical RCTs with different risks and burdens. The transcripts of the interviews were analysed using the principles of grounded theory and framework analysis. Of the 24 consenting participants (12 patient and key-relative dyads), the 20 who completed the interviews had largely positive attitudes towards research and RCTs. However, 50% of those interviewed declined to participate in either of the hypothetical RCTs. The refusal to participate seemed to be influenced by a lack of education; forgetfulness, which impeded the process of making informed decisions; unfavourable benefit-risk-burden ratios; practical difficulties; dependence on treating doctors and relatives for decision-making; and the wish to exercise one's choice regarding treatment options. The factors that motivated the patients and relatives were trust in doctors and organisations, altruism, expectation of personal benefits and favourable risk-benefit ratios. These observations indicate that while the respondents in this study valued research, they were discerning about whether or not to participate in the trials; their decision-making was influenced by individualised assessments of risks and burdens and pragmatic considerations, rather than only by the benefits they would obtain.

Assessing decisional capacity for research participation in psychiatric patients and their relatives

“…c) Assessing willingness to participate in RCT 1: Openended questions were used to assess the patients' and key-relatives' willingness to participate in such a trial, and their perspectives on consenting or declining to participate. Our previous report details these results and the responses to supplementary probes evaluating the possible reasons for participation or nonparticipation (14).…”

“…We also assessed their willingness to participate in two hypothetical RCTs that differed in their methods, and explored their reasons for or against participation. The results of these enquiries are reported elsewhere (14). In this report, we present the results of our ARTICLE Assessing decisional capacity for research participation in psychiatric patients and their relatives evaluations of:…”

“…Our earlier report provides the details of the information sheet and consent form for participation in the study, the sociodemographic and clinical data forms, the CGI-S scale, and the attitudes to the research questionnaire (14).…”

“…The inability to predict outcomes with either intervention was mentioned. Other standard elements required in consent forms for RCTs were also included and are detailed in our previous report (14). b) Comprehension questionnaire for hypothetical RCT 1: A questionnaire containing 10 statements, to be answered with "true/false/unsure/do not know", tested the patients' and key relatives' comprehension and recall of the information provided during the consent procedure.…”

“…f ) Assessing willingness to participate in RCT 2: The patients' willingness to participate in this trial and their reasons for consenting or declining to participate were explored as in the previous hypothetical RCT. The details are reported elsewhere (14).…”