Please use this identifier to cite or link to this item: http://hdl.handle.net/1893/22365
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dc.contributor.authorLoudon, Kirstyen_UK
dc.contributor.authorZwarenstein, Merricken_UK
dc.contributor.authorSullivan, Frank Men_UK
dc.contributor.authorDonnan, Peter Ten_UK
dc.contributor.authorTreweek, Shaunen_UK
dc.date.accessioned2018-04-04T01:18:24Z-
dc.date.available2018-04-04T01:18:24Z-
dc.date.issued2013-04en_UK
dc.identifier.other115en_UK
dc.identifier.urihttp://hdl.handle.net/1893/22365-
dc.description.abstractBackground: If you want to know which of two or more healthcare interventions is most effective, the randomised controlled trial is the design of choice. Randomisation, however, does not itself promote the applicability of the results to situations other than the one in which the trial was done. A tool published in 2009, PRECIS (PRagmatic Explanatory Continuum Indicator Summaries) aimed to help trialists design trials that produced results matched to the aim of the trial, be that supporting clinical decision-making, or increasing knowledge of how an intervention works. Though generally positive, groups evaluating the tool have also found weaknesses, mainly that its inter-rater reliability is not clear, that it needs a scoring system and that some new domains might be needed. The aim of the study is to: Produce an improved and validated version of the PRECIS tool. Use this tool to compare the internal validity of, and effect estimates from, a set of explanatory and pragmatic trials matched by intervention.  Methods: The study has four phases. Phase 1 involves brainstorming and a two-round Delphi survey of authors who cited PRECIS. In Phase 2, the Delphi results will then be discussed and alternative versions of PRECIS-2 developed and user-tested by experienced trialists. Phase 3 will evaluate the validity and reliability of the most promising PRECIS-2 candidate using a sample of 15 to 20 trials rated by 15 international trialists. We will assess inter-rater reliability, and raters’ subjective global ratings of pragmatism compared to PRECIS-2 to assess convergent and face validity. Phase 4, to determine if pragmatic trials sacrifice internal validity in order to achieve applicability, will compare the internal validity and effect estimates of matched explanatory and pragmatic trials of the same intervention, condition and participants. Effect sizes for the trials will then be compared in a meta-regression. The Cochrane Risk of Bias scores will be compared with the PRECIS-2 scores of pragmatism.  Discussion: We have concrete suggestions for improving PRECIS and a growing list of enthusiastic individuals interested in contributing to this work. By early 2014 we expect to have a validated PRECIS-2.en_UK
dc.language.isoenen_UK
dc.publisherBioMed Centralen_UK
dc.relationLoudon K, Zwarenstein M, Sullivan FM, Donnan PT & Treweek S (2013) Making clinical trials more relevant: improving and validating the PRECIS tool for matching trial design decisions to trial purpose.. Trials, 14, Art. No.: 115. https://doi.org/10.1186/1745-6215-14-115en_UK
dc.rights© 2013 Loudon et al.; licensee BioMed Central Ltd. 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.subjectPragmaticen_UK
dc.subjectExplanatoryen_UK
dc.subjectClinical trialsen_UK
dc.subjectTrial designen_UK
dc.subjectApplicabilityen_UK
dc.titleMaking clinical trials more relevant: improving and validating the PRECIS tool for matching trial design decisions to trial purpose.en_UK
dc.typeJournal Articleen_UK
dc.identifier.doi10.1186/1745-6215-14-115en_UK
dc.identifier.pmid23782862en_UK
dc.citation.jtitleTrialsen_UK
dc.citation.issn1745-6215en_UK
dc.citation.volume14en_UK
dc.citation.publicationstatusPublisheden_UK
dc.citation.peerreviewedRefereeden_UK
dc.type.statusVoR - Version of Recorden_UK
dc.author.emailkirsty.loudon@stir.ac.uken_UK
dc.citation.date27/04/2013en_UK
dc.contributor.affiliationHS - Management and Support - LEGACYen_UK
dc.contributor.affiliationUniversity of Western Ontarioen_UK
dc.contributor.affiliationUniversity of Dundeeen_UK
dc.contributor.affiliationUniversity of Dundeeen_UK
dc.contributor.affiliationUniversity of Aberdeenen_UK
dc.identifier.isiWOS:000318990900002en_UK
dc.identifier.scopusid2-s2.0-84891674360en_UK
dc.identifier.wtid585762en_UK
dc.contributor.orcid0000-0002-4449-6226en_UK
dc.date.accepted2013-04-08en_UK
dcterms.dateAccepted2013-04-08en_UK
dc.date.filedepositdate2015-10-27en_UK
rioxxterms.typeJournal Article/Reviewen_UK
rioxxterms.versionVoRen_UK
local.rioxx.authorLoudon, Kirsty|0000-0002-4449-6226en_UK
local.rioxx.authorZwarenstein, Merrick|en_UK
local.rioxx.authorSullivan, Frank M|en_UK
local.rioxx.authorDonnan, Peter T|en_UK
local.rioxx.authorTreweek, Shaun|en_UK
local.rioxx.projectInternal Project|University of Stirling|https://isni.org/isni/0000000122484331en_UK
local.rioxx.freetoreaddate2015-10-27en_UK
local.rioxx.licencehttp://creativecommons.org/licenses/by/4.0/|2015-10-27|en_UK
local.rioxx.filenameLoudon et al_Trials_2013.pdfen_UK
local.rioxx.filecount1en_UK
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