title: 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).
abstract: 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.
authors: Department of Practice and Policy, Centre for Behavioural Medicine, School of Pharmacy, UCL School of Pharmacy, Mezzanine Floor, BMA House, Tavistock Square, London, WC1H 9JP, UK.
authors: Natalie
authors: N
authors: Bidad
authors: Department of Practice and Policy, Centre for Behavioural Medicine, School of Pharmacy, UCL School of Pharmacy, Mezzanine Floor, BMA House, Tavistock Square, London, WC1H 9JP, UK.
authors: Lindsay
authors: L
authors: MacDonald
authors: Breast Cancer Surgery Clinical and Patient Reported Outcomes Research, School of Clinical Sciences, University of Bristol, Level 2 Learning and Research, Southmead Hospital, Bristol, BS10 5NB, UK.
authors: Zoë E
authors: ZE
authors: Winters
authors: Centre for Health Humanities, University College London, Gower Street, London, WC1E 6BT, UK.
authors: Sarah J L
authors: SJ
authors: Edwards
authors: Division of Clinical Studies, The Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU), London, SM2 5NG, UK.
authors: Marie
authors: M
authors: Emson
authors: Division of Clinical Studies, The Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU), London, SM2 5NG, UK.
authors: Clare L
authors: CL
authors: Griffin
authors: Division of Clinical Studies, The Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU), London, SM2 5NG, UK.
authors: Judith
authors: J
authors: Bliss
authors: Department of Practice and Policy, Centre for Behavioural Medicine, School of Pharmacy, UCL School of Pharmacy, Mezzanine Floor, BMA House, Tavistock Square, London, WC1H 9JP, UK. r.horne@ucl.ac.uk.
authors: Rob
authors: R
authors: Horne
mesh_terms: D000328:Adult; D000533:Altruism; D001943:Breast Neoplasms / Q000473:pathology / Q000523:psychology / Q000601:surgery*; D002986:Clinical Trials as Topic; D032882:Comprehension; D005260:Female; D006801:Humans; D007258:Informed Consent; D007407:Interviews as Topic; D016462:Mammaplasty / Q000009:adverse effects / Q000523:psychology; D008408:Mastectomy / Q000009:adverse effects / Q000523:psychology; D008875:Middle Aged; D009042:Motivation; D010342:Patient Acceptance of Health Care; D036301:Qualitative Research; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D035842:Research Subjects / Q000523:psychology*; D013997:Time Factors; D016896:Treatment Outcome
keywords: Altruism; Breast cancer; Informed consent; Qualitative