Please use this identifier to cite or link to this item: http://hdl.handle.net/1893/9843
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dc.contributor.authorWells, Maryen_UK
dc.contributor.authorWilliams, Brianen_UK
dc.contributor.authorTreweek, Shaunen_UK
dc.contributor.authorCoyle, Joanneen_UK
dc.contributor.authorTaylor, Julieen_UK
dc.date.accessioned2015-10-23T23:53:54Z-
dc.date.available2015-10-23T23:53:54Z-
dc.date.issued2012-06en_UK
dc.identifier.other95en_UK
dc.identifier.urihttp://hdl.handle.net/1893/9843-
dc.description.abstractBackground: A number of single case reports have suggested that the context within which intervention studies take place may challenge the assumptions that underpin randomised controlled trials (RCTs). However, the diverse ways in which context may challenge the central tenets of the RCT, and the degree to which this information is known to researchers or subsequently reported, has received much less attention. In this paper, we explore these issues by focusing on seven RCTs of interventions varying in type and degree of complexity, and across diverse contexts. Methods: This in-depth multiple case study using interviews, focus groups and documentary analysis was conducted in two phases. In phase one, a RCT of a nurse-led intervention provided a single exploratory case and informed the design, sampling and data collection within the main study. Phase two consisted of a multiple explanatory case study covering a spectrum of trials of different types of complex intervention. A total of eighty-four data sources across the seven trials were accessed. Results: We present consistent empirical evidence across all trials to indicate that four key elements of context (personal, organisational, trial and problem context) are crucial to understanding how a complex intervention works and to enable both assessments of internal validity and likely generalisability to other settings. The ways in which context challenged trial operation was often complex, idiosyncratic, and subtle; often falling outside of current trial reporting formats. However, information on such issues appeared to be available via first hand 'insider accounts' of each trial suggesting that improved reporting on the role of context is possible. Conclusions: Sufficient detail about context needs to be understood and reported in RCTs of complex interventions, in order for the transferability of complex interventions to be assessed. Improved reporting formats that require and encourage the clarification of both general and project-specific threats to the likely internal and external validity need to be developed. In addition, a cultural change is required in which the open and honest reporting of such issues is seen as an indicator of study strength and researcher integrity, rather than a symbol of a poor quality study or investigator ability.en_UK
dc.language.isoenen_UK
dc.publisherBiomed Centralen_UK
dc.relationWells M, Williams B, Treweek S, Coyle J & Taylor J (2012) Intervention description is not enough: evidence from an in-depth multiple case study on the untold role and impact of context in randomised controlled trials of seven complex interventions. Trials, 13, Art. No.: 95. https://doi.org/10.1186/1745-6215-13-95en_UK
dc.rightsOriginally appeared in: Trials, Volume 13, 06/2012. Published by BioMed Central. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.en_UK
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_UK
dc.subjectRCTen_UK
dc.subjectCase studyen_UK
dc.subjectContexten_UK
dc.subjectComplex interventionsen_UK
dc.subjectHealth Servicesen_UK
dc.subjectMedical care Research Methodologyen_UK
dc.titleIntervention description is not enough: evidence from an in-depth multiple case study on the untold role and impact of context in randomised controlled trials of seven complex interventionsen_UK
dc.typeJournal Articleen_UK
dc.identifier.doi10.1186/1745-6215-13-95en_UK
dc.identifier.pmid22742939en_UK
dc.citation.jtitleTrialsen_UK
dc.citation.issn1745-6215en_UK
dc.citation.volume13en_UK
dc.citation.publicationstatusPublisheden_UK
dc.citation.peerreviewedRefereeden_UK
dc.type.statusVoR - Version of Recorden_UK
dc.author.emailbrian.williams@stir.ac.uken_UK
dc.contributor.affiliationHealth Sciences Research - Stirling - LEGACYen_UK
dc.contributor.affiliationNMAHPen_UK
dc.contributor.affiliationUniversity of Dundeeen_UK
dc.contributor.affiliationNMAHPen_UK
dc.contributor.affiliationHealth Sciences Research - Stirling - LEGACYen_UK
dc.identifier.isiWOS:000309969500001en_UK
dc.identifier.scopusid2-s2.0-84862755598en_UK
dc.identifier.wtid758616en_UK
dc.contributor.orcid0000-0001-5789-2773en_UK
dc.contributor.orcid0000-0003-0000-4354en_UK
dc.date.accepted2012-05-21en_UK
dcterms.dateAccepted2012-05-21en_UK
dc.date.filedepositdate2012-10-29en_UK
rioxxterms.typeJournal Article/Reviewen_UK
rioxxterms.versionVoRen_UK
local.rioxx.authorWells, Mary|0000-0001-5789-2773en_UK
local.rioxx.authorWilliams, Brian|0000-0003-0000-4354en_UK
local.rioxx.authorTreweek, Shaun|en_UK
local.rioxx.authorCoyle, Joanne|en_UK
local.rioxx.authorTaylor, Julie|en_UK
local.rioxx.projectInternal Project|University of Stirling|https://isni.org/isni/0000000122484331en_UK
local.rioxx.freetoreaddate2012-10-29en_UK
local.rioxx.licencehttp://creativecommons.org/licenses/by/4.0/|2012-10-29|en_UK
local.rioxx.filenamewellsetal_Trials_2012.pdfen_UK
local.rioxx.filecount1en_UK
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