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dc.contributor.authorMoynihan, C
dc.contributor.authorLewis, R
dc.contributor.authorHall, E
dc.contributor.authorJones, E
dc.contributor.authorBirtle, A
dc.contributor.authorHuddart, R
dc.contributor.authorSPARE Trial Management Group
dc.date.accessioned2018-07-23T15:32:25Z
dc.date.issued2012-11-29
dc.identifier.citationTrials, 2012, 13 pp. 228 - ?
dc.identifier.issn1745-6215
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/2123
dc.identifier.eissn1745-6215en_US
dc.identifier.doi10.1186/1745-6215-13-228en_US
dc.description.abstractBackground Evidence suggests that poor recruitment into clinical trials rests on a patient 'deficit' model - an inability to comprehend trial processes. Poor communication has also been cited as a possible barrier to recruitment. A qualitative patient interview study was included within the feasibility stage of a phase III non-inferiority Randomized Controlled Trial (RCT) (SPARE, CRUK/07/011) in muscle invasive bladder cancer. The aim was to illuminate problems in the context of randomization.Methods The qualitative study used a 'Framework Analysis' that included 'constant comparison' in which semi-structured interviews are transcribed, analyzed, compared and contrasted both between and within transcripts. Three researchers coded and interpreted data.Results Twenty-four patients agreed to enter the interview study; 10 decliners of randomization and 14 accepters, of whom 2 subsequently declined their allocated treatment.The main theme applying to the majority of the sample was confusion and ambiguity. There was little indication that confusion directly impacted on decisions to enter the SPARE trial. However, confusion did appear to impact on ethical considerations surrounding 'informed consent', as well as cause a sense of alienation between patients and health personnel.Sub-optimal communication in many guises accounted for the confusion, together with the logistical elements of a trial that involved treatment options delivered in a number of geographical locations.Conclusions These data highlight the difficulty of providing balanced and clear trial information within the UK health system, despite best intentions. Involvement of multiple professionals can impact on communication processes with patients who are considering participation in RCTs. Our results led us to question the 'deficit' model of patient behavior. It is suggested that health professionals might consider facilitating a context in which patients feel fully included in the trial enterprise and potentially consider alternatives to randomization where complex interventions are being tested.Trial registration ISRCTN61126465.
dc.formatElectronic
dc.format.extent228 - ?
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectSPARE Trial Management Group
dc.subjectHumans
dc.subjectNeoplasm Invasiveness
dc.subjectConfusion
dc.subjectChemotherapy, Adjuvant
dc.subjectNeoadjuvant Therapy
dc.subjectRadiotherapy, Adjuvant
dc.subjectCystectomy
dc.subjectAttitude of Health Personnel
dc.subjectHealth Knowledge, Attitudes, Practice
dc.subjectCommunication
dc.subjectProfessional-Patient Relations
dc.subjectComprehension
dc.subjectPerception
dc.subjectModels, Psychological
dc.subjectQualitative Research
dc.subjectPatient Selection
dc.subjectInformed Consent
dc.subjectAged
dc.subjectMiddle Aged
dc.subjectResearch Subjects
dc.subjectPatient Acceptance of Health Care
dc.subjectFemale
dc.subjectMale
dc.subjectUrinary Bladder
dc.subjectUrinary Bladder Neoplasms
dc.subjectInterviews as Topic
dc.subjectTherapeutic Equipoise
dc.subjectOrgan Sparing Treatments
dc.subjectUnited Kingdom
dc.titleThe Patient Deficit Model Overturned: a qualitative study of patients' perceptions of invitation to participate in a randomized controlled trial comparing selective bladder preservation against surgery in muscle invasive bladder cancer (SPARE, CRUK/07/011).
dc.typeConference Proceeding
dcterms.dateAccepted2012-11-02
rioxxterms.versionofrecord10.1186/1745-6215-13-228
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by/4.0
rioxxterms.licenseref.startdate2012-11-29en_US
rioxxterms.typeConference Paper/Proceeding/Abstract
dc.relation.isPartOfTrials
pubs.notesNot known
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/Primary Group/ICR Divisions/Clinical Studies/ICR-CTSU Urology and Head and Neck Trials Team
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Clinical Academic Radiotherapy (Huddart)
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/Primary Group/ICR Divisions/Clinical Studies/ICR-CTSU Urology and Head and Neck Trials Team
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Clinical Academic Radiotherapy (Huddart)
pubs.publication-statusPublished
pubs.volume13en_US
pubs.embargo.termsNot known
icr.researchteamClinical Trials & Statistics Uniten_US
icr.researchteamICR-CTSU Urology and Head and Neck Trials Teamen_US
icr.researchteamClinical Academic Radiotherapy (Huddart)en_US
dc.contributor.icrauthorHuddart, Roberten
dc.contributor.icrauthorHall, Emmaen
dc.contributor.icrauthorLewis, Rebeccaen


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