Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials: A Systematic Review.
Hansford HJ., Cashin AG., Jones MD., Swanson SA., Islam N., Douglas SRG., Rizzo RRN., Devonshire JJ., Williams SA., Dahabreh IJ., Dickerman BA., Egger M., Garcia-Albeniz X., Golub RM., Lodi S., Moreno-Betancur M., Pearson S-A., Schneeweiss S., Sterne JAC., Sharp MK., Stuart EA., Hernán MA., Lee H., McAuley JH.
IMPORTANCE: Observational (nonexperimental) studies that aim to emulate a randomized trial (ie, the target trial) are increasingly informing medical and policy decision-making, but it is unclear how these studies are reported in the literature. Consistent reporting is essential for quality appraisal, evidence synthesis, and translation of evidence to policy and practice. OBJECTIVE: To assess the reporting of observational studies that explicitly aimed to emulate a target trial. EVIDENCE REVIEW: We searched Medline, Embase, PsycINFO, and Web of Science for observational studies published between March 2012 and October 2022 that explicitly aimed to emulate a target trial of a health or medical intervention. Two reviewers double-screened and -extracted data on study characteristics, key predefined components of the target trial protocol and its emulation (eligibility criteria, treatment strategies, treatment assignment, outcome[s], follow-up, causal contrast[s], and analysis plan), and other items related to the target trial emulation. FINDINGS: A total of 200 studies that explicitly aimed to emulate a target trial were included. These studies included 26 subfields of medicine, and 168 (84%) were published from January 2020 to October 2022. The aim to emulate a target trial was explicit in 70 study titles (35%). Forty-three studies (22%) reported use of a published reporting guideline (eg, Strengthening the Reporting of Observational Studies in Epidemiology). Eighty-five studies (43%) did not describe all key items of how the target trial was emulated and 113 (57%) did not describe the protocol of the target trial and its emulation. CONCLUSION AND RELEVANCE: In this systematic review of 200 studies that explicitly aimed to emulate a target trial, reporting of how the target trial was emulated was inconsistent. A reporting guideline for studies explicitly aiming to emulate a target trial may improve the reporting of the target trial protocols and other aspects of these emulation attempts.