publication . Article . 2021

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

Orkin, Aaron M.; Gill, Peter J.; Ghersi, Davina; Campbell, Lisa; Sugarman, Jeremy; Emsley, Richard; Steg, Philippe Gabriel; Weijer, Charles; Simes, John; Rombey, Tanja; ...
Closed Access English
  • Published: 20 Jul 2021
  • Country: Denmark
Abstract
<p>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 extenuati...
Subjects
free text 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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