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dc.contributor.authorBidad, N
dc.contributor.authorMacDonald, L
dc.contributor.authorWinters, ZE
dc.contributor.authorEdwards, SJL
dc.contributor.authorEmson, M
dc.contributor.authorGriffin, CL
dc.contributor.authorBliss, J
dc.contributor.authorHorne, R
dc.date.accessioned2016-10-05T14:43:31Z
dc.date.issued2016-09-02
dc.identifier.citationTrials, 2016, 17 (1), pp. 431 - ?
dc.identifier.issn1745-6215
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/160
dc.identifier.eissn1745-6215
dc.identifier.doi10.1186/s13063-016-1550-7
dc.description.abstractBackground 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.Methods 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.Results 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.Conclusions 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.Trial registration QUEST A, ISRCTN38846532 ; Date assigned 6 January 2010. QUEST B, ISRCTN92581226 ; Date assigned 6 January 2010.
dc.formatElectronic
dc.format.extent431 - ?
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://creativecommons.org/licenses/by/4.0
dc.subjectHumans
dc.subjectBreast Neoplasms
dc.subjectTreatment Outcome
dc.subjectMammaplasty
dc.subjectMastectomy
dc.subjectAltruism
dc.subjectMotivation
dc.subjectComprehension
dc.subjectQualitative Research
dc.subjectTime Factors
dc.subjectQuality of Life
dc.subjectInformed Consent
dc.subjectAdult
dc.subjectMiddle Aged
dc.subjectResearch Subjects
dc.subjectPatient Acceptance of Health Care
dc.subjectFemale
dc.subjectClinical Trials as Topic
dc.subjectInterviews as Topic
dc.subjectRandomized Controlled Trials as Topic
dc.titleHow 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).
dc.typeJournal Article
dcterms.dateAccepted2016-08-12
rioxxterms.versionofrecord10.1186/s13063-016-1550-7
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by/4.0
rioxxterms.licenseref.startdate2016-09-02
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfTrials
pubs.issue1
pubs.notesNo embargo
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Clinical Trials & Statistics Unit
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Clinical Trials & Statistics Unit
pubs.publication-statusPublished
pubs.volume17
pubs.embargo.termsNo embargo
icr.researchteamClinical Trials & Statistics Uniten_US
dc.contributor.icrauthorEmson, Marieen
dc.contributor.icrauthorGriffin, Clareen
dc.contributor.icrauthorBliss, Judithen


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