Please use this identifier to cite or link to this item: http://hdl.handle.net/1893/25401
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dc.contributor.authorAvery, Kerry N Len_UK
dc.contributor.authorWilliamson, Paulaen_UK
dc.contributor.authorGamble, Carrolen_UK
dc.contributor.authorFrancischetto, Elaine O'Connellen_UK
dc.contributor.authorMetcalfe, Chrisen_UK
dc.contributor.authorDavidson, Peteren_UK
dc.contributor.authorWilliams, Hywelen_UK
dc.contributor.authorBlazeby, Jane Men_UK
dc.contributor.authorBlencowe, Natalieen_UK
dc.contributor.authorBugge, Carolen_UK
dc.contributor.authorCampbell, Michael Jen_UK
dc.contributor.authorCollinson, Michelleen_UK
dc.contributor.authorCooper, Cindyen_UK
dc.contributor.authorDarbyshire, Janeten_UK
dc.contributor.authorDimairo, Munyaen_UK
dc.date.accessioned2017-05-30T01:03:23Z-
dc.date.available2017-05-30T01:03:23Z-
dc.date.issued2017-02en_UK
dc.identifier.othere013537en_UK
dc.identifier.urihttp://hdl.handle.net/1893/25401-
dc.description.abstractObjectives Designing studies with an internal pilot phase may optimise the use of pilot work to inform more efficient randomised controlled trials (RCTs). Careful selection of preagreed decision or ‘progression’ criteria at the juncture between the internal pilot and main trial phases provides a valuable opportunity to evaluate the likely success of the main trial and optimise its design or, if necessary, to make the decision not to proceed with the main trial. Guidance on the appropriate selection and application of progression criteria is, however, lacking. This paper outlines the key issues to consider in the optimal development and review of operational progression criteria for RCTs with an internal pilot phase.  Design A structured literature review and exploration of stakeholders' opinions at a Medical Research Council (MRC) Hubs for Trials Methodology Research workshop. Key stakeholders included triallists, methodologists, statisticians and funders.  Results There is considerable variation in the use of progression criteria for RCTs with an internal pilot phase, although 3 common issues predominate: trial recruitment, protocol adherence and outcome data. Detailed and systematic reporting around the decision-making process for stopping, amending or proceeding to a main trial is uncommon, which may hamper understanding in the research community about the appropriate and optimal use of RCTs with an internal pilot phase. 10 top tips for the development, use and reporting of progression criteria for internal pilot studies are presented.  Conclusions Systematic and transparent reporting of the design, results and evaluation of internal pilot trials in the literature should be encouraged in order to facilitate understanding in the research community and to inform future trials.en_UK
dc.language.isoenen_UK
dc.publisherBMJ Publishing Groupen_UK
dc.relationAvery KNL, Williamson P, Gamble C, Francischetto EO, Metcalfe C, Davidson P, Williams H, Blazeby JM, Blencowe N, Bugge C, Campbell MJ, Collinson M, Cooper C, Darbyshire J & Dimairo M (2017) Informing efficient randomised controlled trials: Exploration of challenges in developing progression criteria for internal pilot studies. BMJ Open, 7 (2), Art. No.: e013537. https://doi.org/10.1136/bmjopen-2016-013537en_UK
dc.rightsThis is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/en_UK
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_UK
dc.titleInforming efficient randomised controlled trials: Exploration of challenges in developing progression criteria for internal pilot studiesen_UK
dc.typeJournal Articleen_UK
dc.identifier.doi10.1136/bmjopen-2016-013537en_UK
dc.identifier.pmid28213598en_UK
dc.citation.jtitleBMJ Openen_UK
dc.citation.issn2044-6055en_UK
dc.citation.volume7en_UK
dc.citation.issue2en_UK
dc.citation.publicationstatusPublisheden_UK
dc.citation.peerreviewedRefereeden_UK
dc.type.statusVoR - Version of Recorden_UK
dc.citation.date17/02/2017en_UK
dc.description.notesNatalie Blencowe, Carol Bugge, Michael Campbell, Michelle Collinson, Cindy Cooper, Janet Darbyshire, Munya Dimairo, and the following co-authors are credited as members of the Internal Pilot Trials Workshop supported by the Hubs for Trials Methodology Research rather than as explicitly co-authors: Caroline Doré, Sandra Eldridge, Simon Gilbody, Steve Goodacre, Lisa Hampson, Angelos G Kolias, Sallie Lamb, Athene Lane, John Norrie, Gillian Shorter, and Shaun Treweek.en_UK
dc.contributor.affiliationUniversity of Bristolen_UK
dc.contributor.affiliationUniversity of Liverpoolen_UK
dc.contributor.affiliationUniversity of Liverpoolen_UK
dc.contributor.affiliationUniversity of Bristolen_UK
dc.contributor.affiliationUniversity of Bristolen_UK
dc.contributor.affiliationUniversity of Southamptonen_UK
dc.contributor.affiliationUniversity of Nottinghamen_UK
dc.contributor.affiliationUniversity of Bristolen_UK
dc.contributor.affiliationUniversity of Bristolen_UK
dc.contributor.affiliationHealth Sciences Stirlingen_UK
dc.contributor.affiliationUniversity of Sheffielden_UK
dc.contributor.affiliationUniversity of Leedsen_UK
dc.contributor.affiliationUniversity of Sheffielden_UK
dc.contributor.affiliationArthritis Research UKen_UK
dc.contributor.affiliationUniversity of Sheffielden_UK
dc.identifier.isiWOS:000397872400079en_UK
dc.identifier.scopusid2-s2.0-85013345088en_UK
dc.identifier.wtid534786en_UK
dc.contributor.orcid0000-0002-4071-0803en_UK
dc.date.accepted2017-01-19en_UK
dcterms.dateAccepted2017-01-19en_UK
dc.date.filedepositdate2017-05-29en_UK
rioxxterms.apcnot requireden_UK
rioxxterms.typeJournal Article/Reviewen_UK
rioxxterms.versionVoRen_UK
local.rioxx.authorAvery, Kerry N L|en_UK
local.rioxx.authorWilliamson, Paula|en_UK
local.rioxx.authorGamble, Carrol|en_UK
local.rioxx.authorFrancischetto, Elaine O'Connell|en_UK
local.rioxx.authorMetcalfe, Chris|en_UK
local.rioxx.authorDavidson, Peter|en_UK
local.rioxx.authorWilliams, Hywel|en_UK
local.rioxx.authorBlazeby, Jane M|en_UK
local.rioxx.authorBlencowe, Natalie|en_UK
local.rioxx.authorBugge, Carol|0000-0002-4071-0803en_UK
local.rioxx.authorCampbell, Michael J|en_UK
local.rioxx.authorCollinson, Michelle|en_UK
local.rioxx.authorCooper, Cindy|en_UK
local.rioxx.authorDarbyshire, Janet|en_UK
local.rioxx.authorDimairo, Munya|en_UK
local.rioxx.projectInternal Project|University of Stirling|https://isni.org/isni/0000000122484331en_UK
local.rioxx.freetoreaddate2017-05-29en_UK
local.rioxx.licencehttp://creativecommons.org/licenses/by/4.0/|2017-05-29|en_UK
local.rioxx.filenamee013537.full.pdfen_UK
local.rioxx.filecount1en_UK
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