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dc.contributor.authorOrkin, Aaron M.en_AU
dc.contributor.authorGill, Peter J.en_AU
dc.contributor.authorGhersi, Davinaen_AU
dc.contributor.authorCampbell, Lisaen_AU
dc.contributor.authorSugarman, Jeremyen_AU
dc.contributor.authorEmsley, Richarden_AU
dc.contributor.authorSteg, Philippe Gabrielen_AU
dc.contributor.authorWeijer, Charlesen_AU
dc.contributor.authorSimes, Johnen_AU
dc.contributor.authorRombey, Tanjaen_AU
dc.contributor.authorWilliams, Hywel C.en_AU
dc.contributor.authorWittes, Janeten_AU
dc.contributor.authorMoher, Daviden_AU
dc.contributor.authorRichards, Dawn P.en_AU
dc.contributor.authorKasamon, Yvetteen_AU
dc.contributor.authorGetz, Kennethen_AU
dc.contributor.authorHopewell, Sallyen_AU
dc.contributor.authorDickersin, Kayen_AU
dc.contributor.authorWu, Taixiangen_AU
dc.contributor.authorAyala, Ana Patriciaen_AU
dc.contributor.authorSchulz, Kenneth F.en_AU
dc.contributor.authorCalleja, Sabineen_AU
dc.contributor.authorBoutron, Isabelleen_AU
dc.contributor.authorRoss, Joseph S.en_AU
dc.contributor.authorGolub, Robert M.en_AU
dc.contributor.authorKhan, Karim M.en_AU
dc.contributor.authorMulrow, Cindyen_AU
dc.contributor.authorSiegfried, Nandien_AU
dc.contributor.authorHeber, Joergen_AU
dc.contributor.authorLee, Naomien_AU
dc.contributor.authorKearney, Pamela Reeden_AU
dc.contributor.authorWanyenze, Rhoda K.en_AU
dc.contributor.authorHróbjartsson, Asbjørnen_AU
dc.contributor.authorWilliams, Rebeccaen_AU
dc.contributor.authorBhandari, Nitaen_AU
dc.contributor.authorJüni, Peteren_AU
dc.contributor.authorChan, An-Wenen_AU
dc.contributor.authorOrkin, Aaron M.en_AU
dc.contributor.authorGill, Peter J.en_AU
dc.contributor.authorGhersi, Davinaen_AU
dc.contributor.authorCampbell, Lisaen_AU
dc.contributor.authorSugarman, Jeremyen_AU
dc.contributor.authorEmsley, Richarden_AU
dc.contributor.authorSteg, Philippe Gabrielen_AU
dc.contributor.authorWeijer, Charlesen_AU
dc.contributor.authorSimes, Johnen_AU
dc.contributor.authorRombey, Tanjaen_AU
dc.contributor.authorWilliams, Hywel C.en_AU
dc.contributor.authorWittes, Janeten_AU
dc.contributor.authorMoher, Daviden_AU
dc.contributor.authorRichards, Dawn P.en_AU
dc.contributor.authorKasamon, Yvetteen_AU
dc.contributor.authorGetz, Kennethen_AU
dc.contributor.authorHopewell, Sallyen_AU
dc.contributor.authorDickersin, Kayen_AU
dc.contributor.authorWu, Taixiangen_AU
dc.contributor.authorAyala, Ana Patriciaen_AU
dc.contributor.authorSchulz, Kenneth F.en_AU
dc.contributor.authorCalleja, Sabineen_AU
dc.contributor.authorBoutron, Isabelleen_AU
dc.contributor.authorRoss, Joseph S.en_AU
dc.contributor.authorGolub, Robert M.en_AU
dc.contributor.authorKhan, Karim M.en_AU
dc.contributor.authorMulrow, Cindyen_AU
dc.contributor.authorSiegfried, Nandien_AU
dc.contributor.authorHeber, Joergen_AU
dc.contributor.authorLee, Naomien_AU
dc.contributor.authorKearney, Pamela Reeden_AU
dc.contributor.authorWanyenze, Rhoda K.en_AU
dc.contributor.authorHróbjartsson, Asbjørnen_AU
dc.contributor.authorWilliams, Rebeccaen_AU
dc.contributor.authorBhandari, Nitaen_AU
dc.contributor.authorJüni, Peteren_AU
dc.contributor.authorChan, An-Wenen_AU
dc.contributor.authorKiermer, Veroniqueen_AU
dc.contributor.authorCorrigan-Curay, Jacquelineen_AU
dc.contributor.authorConcato, Johnen_AU
dc.date.accessioned2021-07-06T23:34:23Z
dc.date.available2021-07-06T23:34:23Z
dc.date.issued2021
dc.identifier.urihttps://hdl.handle.net/2123/25608
dc.description.abstractImportance: Extenuating circumstances can trigger unplanned changes to randomized trials and introduce methodological, ethical, feasibility, and analytical challenges that can potentially compromise the validity of findings. Numerous randomized trials have required changes in response to the COVID-19 pandemic, but guidance for reporting such modifications is incomplete. Objective: As a joint extension for the CONSORT and SPIRIT reporting guidelines, CONSERVE (CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstances) aims to improve reporting of trial protocols and completed trials that undergo important modifications in response to extenuating circumstances. Evidence: A panel of 37 international trial investigators, patient representatives, methodologists and statisticians, ethicists, funders, regulators, and journal editors convened to develop the guideline. The panel developed CONSERVE following an accelerated, iterative process between June 2020 and February 2021 involving (1) a rapid literature review of multiple databases (OVID Medline, OVID EMBASE, and EBSCO CINAHL) and gray literature sources from 2003 to March 2021; (2) consensus-based panelist meetings using a modified Delphi process and surveys; and (3) a global survey of trial stakeholders. Findings: The rapid review yielded 41 673 citations, of which 38 titles were relevant, including emerging guidance from regulatory and funding agencies for managing the effects of the COVID-19 pandemic on trials. However, no generalizable guidance for all circumstances in which trials and trial protocols might face unanticipated modifications were identified. The CONSERVE panel used these findings to develop a consensus reporting guidelines following 4 rounds of meetings and surveys. Responses were received from 198 professionals from 34 countries, of whom 90% (n = 178) indicated that they understood the concept definitions and 85.4% (n = 169) indicated that they understood and could use the implementation tool. Feedback from survey respondents was used to finalize the guideline and confirm that the guideline's core concepts were applicable and had utility for the trial community. CONSERVE incorporates an implementation tool and checklists tailored to trial reports and trial protocols for which extenuating circumstances have resulted in important modifications to the intended study procedures. The checklists include 4 sections capturing extenuating circumstances, important modifications, responsible parties, and interim data analyses. Conclusions and Relevance: CONSERVE offers an extension to CONSORT and SPIRIT that could improve the transparency, quality, and completeness of reporting important modifications to trials in extenuating circumstances such as COVID-19.en_AU
dc.language.isoenen_AU
dc.subjectCOVID-19en_AU
dc.subjectCoronavirusen_AU
dc.titleGuidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstancesen_AU
dc.typeArticleen_AU
dc.identifier.doi10.1001/jama.2021.9941


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