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dc.contributor.authorBoote, Jonathan
dc.contributor.authorBaird, Wendy
dc.contributor.authorSutton, Anthea
dc.identifier.citationBoote , J , Baird , W & Sutton , A 2011 , ' Public involvement in the design and conduct of clinical trials : A review ' , International Journal of Interdisciplinary Social Sciences , vol. 5 , no. 11 , pp. 91-111 .
dc.identifier.otherPURE: 8115180
dc.identifier.otherPURE UUID: 3c0d85e3-43fe-49cc-8dd5-fbbf6068293d
dc.identifier.otherScopus: 79961238897
dc.description.abstractBackground: Public involvement is health research policy in the UK and internationally. There is a need to establish a robust evidence base on the impact of public involvement on research processes and outcomes. Purpose: To review examples of public involvement in the design and conduct of clinical trials, to synthesise the contributions of the public, as well as the identified tensions and facilitating strategies. Method: Systematic literature search and narrative review. Results: Nine papers were identified, covering the following topics: breast-feeding, antiretroviral and nutrition interventions; paediatric resuscitation; exercise and cognitive behavioural therapy; breast cancer; stroke; chronic suppurative otitis media; Paget's disease; and shared decision-making in patient consultations. Six papers reported on public involvement at the trial design stage, while three reported on public involvement at the design and conduct stages of clinical trials. It was found that the public contributed at the consultation, collaboration and publicly-led levels of involvement. Four main public contributions to trial design were identified: review of consent procedures and patient information sheets; suggestion of additional trial outcomes; review of trial data collection procedures; and recommendations on the timing and location of follow-up data collection. Two main contributions that the public made to the conduct of trials were identified: scrutiny of the conduct of the trial through membership of the Trial Steering Committee; and delivering the trial protocol after completing relevant training. Numerous tensions and facilitating strategies were identified. Limitations: Papers on public involvement in the design and conduct of clinical trials may have been overlooked due to the difficulty of searching for, and identifying, papers in this area. Only English publications were searched for and the review focused on evidence in peer-reviewed journal articles only. Conclusions: The issues raised here should assist researchers in developing and conducting clinical trials with the involvement of the public.en
dc.relation.ispartofInternational Journal of Interdisciplinary Social Sciences
dc.subjectClinical trials
dc.subjectNarrative literature review
dc.subjectPublic involvement
dc.subjectSocial Sciences(all)
dc.titlePublic involvement in the design and conduct of clinical trials : A reviewen
dc.contributor.institutionSchool of Health and Social Work
dc.contributor.institutionHealth & Human Sciences Research Institute
dc.contributor.institutionCentre for Research in Public Health and Community Care
dc.contributor.institutionDepartment of Adult Nursing and Primary Care
dc.description.statusPeer reviewed
rioxxterms.typeJournal Article/Review

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