Dublin Core PKP Metadata Items Metadata for this Document
1. Title Title of document Participation in randomised controlled trials: perspectives of psychiatric patients and key relatives
2. Creator Author's name, affiliation, country Donae Elizabeth George; Psychiatry Unit II, Christian Medical College, Vellore, Tamil Nadu, India
3. Subject Discipline(s)
3. Subject Keyword(s)
4. Description 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.
5. Publisher Organizing agency, location Forum for Medical Ethics Society
6. Contributor Sponsor(s)
7. Date (YYYY-MM-DD) 2017-08-01
8. Type Status & genre
8. Type Type
9. Format File format HTML , PDF
10. Identifier Uniform Resource Identifier http://ijme.in/articles/participation-in-randomised-controlled-trials-perspectives-of-psychiatric-patients-and-key-relatives/
11. Source Title; vol., no. (year) Indian Journal of Medical Ethics;: Can medical ethics be “neutral”?
12. Language English=en en
13. Relation Supp. Files
14. Coverage Geo-spatial location, chronological period, research sample (gender, age, etc.)
15. Rights Copyright and permissions

All articles published in IJME are available on its website free of charge. The copyright for published material belongs to IJME/FMES. IJME freely permits the reprint (or reproduction on a website) of articles from the journal, as long as this is for non-commercial use and appropriate credit is given to the author and the journal and publication details are mentioned. The commercial use of our content can be made only after obtaining permission from and on payment to IJME. This is intended to support production of the journal.