Article type
Year
Abstract
Objectives:
To understand the perspectives of Indian patients undergoing treatment for major psychiatric disorders, and of their relatives, regarding participation in randomised clinical trials (RCTs), and to assess their competence to consent.
Methods:
A cross-sectional quantitative and qualitative study using the 'Prospective Preference Assessment' method on moderately-ill, consenting, psychiatric inpatients, and their relatives, assessed their attitudes to participation in RCTs; their comprehension of information regarding two hypothetical trials; their willingness to participate; and the barriers and facilitators to participation. Clinical assessments of the capacity to consent were supplemented, in a sub-set, by independent assessments using the MacArthur Competence Assessment Tool for Clinical Research (MaCAT-CR). Quantitative data were presented as frequencies and qualitative data from audio-recorded, verbatim transcripts, were analysed for themes using the 'Grounded theory' framework.
Results:
All 20 participants (nine patients, 11 relatives) endorsed the need for RCTs and their methods; and altruism as a motive for participation. Only 50% were willing to participate in the hypothetical trials. Comprehension of information sheets was sub-optimal. Trust in doctors and organisations, and the opinions of family members’ facilitated participation. Unfavourable risk/benefit ratios, the use of placebos, distrust in doctors and organisations, financial and other hardships, and opinions of family members were barriers. The majority of participants judged competent on clinical assessment failed formal tests of competence to consent.
To understand the perspectives of Indian patients undergoing treatment for major psychiatric disorders, and of their relatives, regarding participation in randomised clinical trials (RCTs), and to assess their competence to consent.
Methods:
A cross-sectional quantitative and qualitative study using the 'Prospective Preference Assessment' method on moderately-ill, consenting, psychiatric inpatients, and their relatives, assessed their attitudes to participation in RCTs; their comprehension of information regarding two hypothetical trials; their willingness to participate; and the barriers and facilitators to participation. Clinical assessments of the capacity to consent were supplemented, in a sub-set, by independent assessments using the MacArthur Competence Assessment Tool for Clinical Research (MaCAT-CR). Quantitative data were presented as frequencies and qualitative data from audio-recorded, verbatim transcripts, were analysed for themes using the 'Grounded theory' framework.
Results:
All 20 participants (nine patients, 11 relatives) endorsed the need for RCTs and their methods; and altruism as a motive for participation. Only 50% were willing to participate in the hypothetical trials. Comprehension of information sheets was sub-optimal. Trust in doctors and organisations, and the opinions of family members’ facilitated participation. Unfavourable risk/benefit ratios, the use of placebos, distrust in doctors and organisations, financial and other hardships, and opinions of family members were barriers. The majority of participants judged competent on clinical assessment failed formal tests of competence to consent.