How informed is declared altruism in clinical trials? A qualitative interview study of patient decision-making about the QUEST trials (Quality of Life after Mastectomy and Breast Reconstruction)
Tóm tắt
Randomised controlled trials (RCTs) often fail to recruit sufficient participants, despite altruism being cited as their motivation. Previous investigations of factors influencing participation decisions have been methodologically limited. This study evaluated how women weigh up different motivations after initially expressing altruism, and explored their understanding of a trial and its alternatives. The trial was the ‘Quality of Life after Mastectomy and Breast Reconstruction’ (QUEST) trial. Thirty-nine women participated in qualitative interviews 1 month post-surgery. Twenty-seven women (10 trial decliners and 17 acceptors) who spontaneously mentioned ‘altruism’ were selected for thematic analysis. Verbatim transcripts were coded independently by two researchers. Participants’ motivations to accept or decline randomisation were cross-referenced with their understanding of the QUEST trials and the process of randomisation. The seven emerging themes were: (1) altruism expressed by acceptors and decliners; (2) overriding personal needs in decliners; (3) pure altruism in acceptors; (4) ‘hypothetical altruism’ amongst acceptors; (5) weak altruism amongst acceptors; (6) conditional altruism amongst acceptors; and (7) sense of duty to participate. Poor understanding of the trial rationale and its implications was also evident. Altruism was a motivating factor for participation in the QUEST randomised controlled trials where the main outcomes comprised quality of life and allocated treatments comprised established surgical procedures. Women’s decisions were influenced by their understanding of the trial. Both acceptors and decliners of the trial expressed ‘altruism’, but most acceptors lacked an obvious treatment preference, hoped for personal benefits regarding a treatment allocation, or did not articulate complete understanding of the trial. QUEST A,
ISRCTN38846532
; Date assigned 6 January 2010. QUEST B,
ISRCTN92581226
; Date assigned 6 January 2010.
Tài liệu tham khảo
McDonald A, Knight R, Campbell M, Entwistle V, Grant A, Cook J, Elbourne D, Francis D, Garcia J, Roberts I, Snowdon C. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006;7:9.
Truong TH, Weeks JC, Cook EF, Joffe S. Altruism among participants in cancer clinical trials. Clin Trials. 2011;8:616–23.
Rosenbaum JR, Wells CK, Viscoli CM, Brass LM, Kernan WN, Horwitz RI. Altruism as a reason for participation in clinical trials was independently associated with adherence. J Clin Epidemiol. 2005;58:1109–14.
Edwards SJL, Lilford RJ, Hewison J. The ethics of randomised controlled trials from the perspectives of patients, the public, and healthcare professionals. Brit Med J. 1998;317:1209–12.
Treweek S, Mitchell E, Pitkethly M, Cook J, Kjeldstrøm M, Johansen M, Taskila Taina K, Sullivan F, Wilson S, Jackson C, Jones R, Lockhart P. Strategies to improve recruitment to randomised controlled trials. Cochrane Database of Syst Rev. 2010: MR000013. doi:10.1002/14651858.MR000013.pub4.
Jenkins V, Fallowfield L. Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy. Br J Cancer. 2000;82:1783–8.
Jenkins V, Farewell V, Farewell D, Darmanin J, Wagstaff J, Langridge C, Fallowfield L. Drivers and barriers to patient participation in RCTs. Br J Cancer. 2013;108:1402–7.
McCann SK, Campbell MK, Entwistle VA. Reasons for participating in randomised controlled trials: conditional altruism and considerations for self. Trials. 2010;11:31.
Winters Z, Emson M, Griffin C, Mills J, Hopwood P, Bidad N, MacDonald L, Turton E, Horne R, Bliss J. Learning from the QUEST multicentre feasibility randomization trials in breast reconstruction after mastectomy. Br J Surg. 2015;102:45–56.
Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3:77–101.
Bidad N, MacDonald L, Winters Z, Edwards S, Horne R. Views on the right to withdraw from randomised controlled trials assessing quality of life after mastectomy and breast reconstruction (QUEST): findings from the QUEST perspectives study (QPS). Res Ethics. 2014;10:47–57.
Braunholtz DA, Edwards SJL, Lilford RJ. Are randomized clinical trials good for us (in the short term)? Evidence for a “trial effect”. J Clin Epidemiol. 2001;54:217–24.
Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet. 2001;358:1772–7.
Cook JA, Elders A, Boachie C, Bassinga T, Fraser C, Altman DG, Boultron I, Ramsey CR, MacLennan GS. A systematic review of the use of an expertise-based randomised control design. Trials. 2015;16:241.