Reporting Clinical Studies Affected by the COVID-19 Pandemic: Guidelines for Authors

Abstract

The coronavirus disease 2019 (COVID-19) pandemic has affected every area of society, and clinical investigation is no exception.1 The unprecedented speed and volume of scientific reports related to COVID-19, while challenging for editors and reviewers, is a testament to investigators' determination to continue their work.2 On the other hand, the pandemic has also necessitated substantial changes in the conduct of medical research, particularly clinical trials and prospective observational studies.Maintaining participant and study staff safety has often required modifications to the design and conduct of studies, impacting everything from recruitment to follow-up and sometimes delaying analysis and reporting of results.In this Editorial we provide guidance to authors on how to acknowledge any COVID-19 pandemic-related changes to their studies in submitted manuscripts.Our goal is to make authors aware of expectations regarding transparent communication of study results that may have been affected by the pandemic.Specifically, for studies that have been affected by the pandemic, the Methods section should include a subsection titled "Changes in Response to the COVID-19Pandemic" and incorporate the following information, as applicable. Change in Study ProtocolPandemic research conditions may require a range of revisions to study protocols.These may include modifications to the eligibility criteria, the intervention, the outcome measure, and the analysis.As expected with any clinical trial, the editors expect that any significant modifications to the protocol will be clearly indicated in an amendment to the protocol and will be reflected in an updated study registration (eg, at ClinicalTrials.gov or equivalent).If the primary outcome is modified, this will need to be justified, and the original primary outcome must still be presented even if only available for a subset of patients.Such modifications to the protocol may require review by an ethics oversight board or data safety monitoring board, which should also be noted (even if such review was formally waived or exempted).Changes to the study population or intervention, even those the investigators believe are minimal, may lead to heterogeneous effects within the trial.Supplemental analyses should be presented to investigate this possibility by exploring treatment effect interactions by subpopulations or changes in interventions, including intervention delivery, necessitated by COVID-19. Trial Delays and InterruptionsWe recognize that the pandemic may lead to a delay in reporting results, which will not preclude consideration for publication in JAMA Network Open, if reasonable and justified in the manuscript.Any interruptions in study recruitment or follow-up should be stated with start and stop dates.