Please use this identifier to cite or link to this item: http://hdl.handle.net/1893/24494
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dc.contributor.authorEldridge, Sandraen_UK
dc.contributor.authorChan, Claire Len_UK
dc.contributor.authorCampbell, Michael Jen_UK
dc.contributor.authorBond, Christine Men_UK
dc.contributor.authorHopewell, Sallyen_UK
dc.contributor.authorThabane, Lehanaen_UK
dc.contributor.authorLancaster, Gillian Aen_UK
dc.contributor.authorAltman, Doug Gen_UK
dc.contributor.authorBretz, Franken_UK
dc.contributor.authorCampbell, Marion Ken_UK
dc.contributor.authorCobo, Eriken_UK
dc.contributor.authorCraig, Peteren_UK
dc.contributor.authorDavidson, Peteren_UK
dc.contributor.authorGroves, Trishen_UK
dc.contributor.authorHoddinott, Paten_UK
dc.date.accessioned2018-01-20T04:22:41Z-
dc.date.available2018-01-20T04:22:41Z-
dc.date.issued2016-10-29en_UK
dc.identifier.otheri5239en_UK
dc.identifier.urihttp://hdl.handle.net/1893/24494-
dc.description.abstractConsolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply.  The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist.  The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number.  This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials.  Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites.en_UK
dc.language.isoenen_UK
dc.publisherBMJ Publishing Groupen_UK
dc.relationEldridge S, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA, Altman DG, Bretz F, Campbell MK, Cobo E, Craig P, Davidson P, Groves T & Hoddinott P (2016) CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ, 355 (8079), Art. No.: i5239. https://doi.org/10.1136/bmj.i5239en_UK
dc.rightsThis is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 3.0) 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/3.0/.en_UK
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_UK
dc.titleCONSORT 2010 statement: extension to randomised pilot and feasibility trialsen_UK
dc.typeJournal Articleen_UK
dc.identifier.doi10.1136/bmj.i5239en_UK
dc.identifier.pmid27777223en_UK
dc.citation.jtitleBMJen_UK
dc.citation.issn1756-1833en_UK
dc.citation.issn0959-8138en_UK
dc.citation.volume355en_UK
dc.citation.issue8079en_UK
dc.citation.publicationstatusPublisheden_UK
dc.citation.peerreviewedRefereeden_UK
dc.type.statusVoR - Version of Recorden_UK
dc.contributor.funderMedical Research Councilen_UK
dc.author.emailp.m.hoddinott@stir.ac.uken_UK
dc.citation.date24/10/2016en_UK
dc.description.notesAdditional co-authors: Freedom Gumedze, Jenny Hewison, Allison Hirst, Sarah E Lamb, Tom Lang, Elaine McColl, Alicia O’Cathain, Daniel R Shanahan, Chris Sutton, and Peter Tugween_UK
dc.contributor.affiliationQueen Mary, University of Londonen_UK
dc.contributor.affiliationQueen Mary, University of Londonen_UK
dc.contributor.affiliationUniversity of Sheffielden_UK
dc.contributor.affiliationUniversity of Aberdeenen_UK
dc.contributor.affiliationUniversity of Oxforden_UK
dc.contributor.affiliationMcMaster Universityen_UK
dc.contributor.affiliationLancaster Universityen_UK
dc.contributor.affiliationUniversity of Oxforden_UK
dc.contributor.affiliationMedical University of Viennaen_UK
dc.contributor.affiliationUniversity of Aberdeenen_UK
dc.contributor.affiliationPolytechnic University of Catalonia - BarcelonaTechen_UK
dc.contributor.affiliationUniversity of Glasgowen_UK
dc.contributor.affiliationUniversity of Southamptonen_UK
dc.contributor.affiliationBMJ Publishing Groupen_UK
dc.contributor.affiliationNMAHPen_UK
dc.identifier.isiWOS:000386660200001en_UK
dc.identifier.scopusid2-s2.0-84994026521en_UK
dc.identifier.wtid544883en_UK
dc.contributor.orcid0000-0002-4372-9681en_UK
dc.date.accepted2016-09-18en_UK
dcterms.dateAccepted2016-09-18en_UK
dc.date.filedepositdate2016-11-03en_UK
dc.relation.funderprojectCollaboration and innovation for Difficult and Complex randomised controlled Trials In Invasive proceduresen_UK
dc.relation.funderrefMR/k025643/1en_UK
rioxxterms.apcnot requireden_UK
rioxxterms.typeJournal Article/Reviewen_UK
rioxxterms.versionVoRen_UK
local.rioxx.authorEldridge, Sandra|en_UK
local.rioxx.authorChan, Claire L|en_UK
local.rioxx.authorCampbell, Michael J|en_UK
local.rioxx.authorBond, Christine M|en_UK
local.rioxx.authorHopewell, Sally|en_UK
local.rioxx.authorThabane, Lehana|en_UK
local.rioxx.authorLancaster, Gillian A|en_UK
local.rioxx.authorAltman, Doug G|en_UK
local.rioxx.authorBretz, Frank|en_UK
local.rioxx.authorCampbell, Marion K|en_UK
local.rioxx.authorCobo, Erik|en_UK
local.rioxx.authorCraig, Peter|en_UK
local.rioxx.authorDavidson, Peter|en_UK
local.rioxx.authorGroves, Trish|en_UK
local.rioxx.authorHoddinott, Pat|0000-0002-4372-9681en_UK
local.rioxx.projectMR/k025643/1|Medical Research Council|http://dx.doi.org/10.13039/501100000265en_UK
local.rioxx.freetoreaddate2016-11-03en_UK
local.rioxx.licencehttp://creativecommons.org/licenses/by/4.0/|2016-11-03|en_UK
local.rioxx.filenamebmj.i5239.full.pdfen_UK
local.rioxx.filecount1en_UK
local.rioxx.source0959-8138en_UK
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