Reporting Clinical Studies Affected by the COVID-19 Pandemic: Guidelines for Authors
Roy H. Perlis, Sebastien Haneuse, Gordon D. Rubenfeld, Stephan D. Fihn, Frederick P. Rivara
Abstract
The coronavirus disease 2019 (COVID-19) pandemic has affected every area of society, and clinical investigation is no exception. 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. 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-19