Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances: The CONSERVE 2021 Statement

Aaron M. Orkin*, Peter J. Gill, Davina Ghersi, Lisa Campbell, Jeremy Sugarman, Richard Emsley, Philippe Gabriel Steg, Charles Weijer, John Simes, Tanja Rombey, Hywel C. Williams, Janet Wittes, David Moher, Dawn P. Richards, Yvette Kasamon, Kenneth Getz, Sally Hopewell, Kay Dickersin, Taixiang Wu, Ana Patricia AyalaKenneth F. Schulz, Sabine Calleja, Isabelle Boutron, Joseph S. Ross, Robert M. Golub, Karim M. Khan, Cindy Mulrow, Nandi Siegfried, Joerg Heber, Naomi Lee, Pamela Reed Kearney, Rhoda K. Wanyenze, Asbjørn Hróbjartsson, Rebecca Williams, Nita Bhandari, Peter Jüni, An Wen Chan

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

Abstract

Importance: 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 41673 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..

Original languageEnglish
JournalJAMA - Journal of the American Medical Association
Volume326
Issue number3
Pages (from-to)257-265
ISSN0098-7484
DOIs
Publication statusPublished - 20. Jul 2021

Keywords

  • COVID-19
  • Clinical Protocols
  • Delphi Technique
  • Guidelines as Topic
  • Humans
  • Publishing/standards
  • Randomized Controlled Trials as Topic/standards
  • Research Report/standards
  • Surveys and Questionnaires

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