Clinical trials of pharmacological interventions for SARS‐CoV‐2 published in leading medical journals report adherence but not how it was assessed

Abstract

BackgroundAdherence to pharmacological interventions in clinical trials is crucial for accurate identification of beneficial and adverse outcomes. The ways in which adherence to interventions should be reported in trial publications are described in the Template for Intervention Description and Replication (TIDieR), a 12‐item extension of the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines.ObjectiveTo assess compliance with TIDieR items 11 and 12 of randomised controlled trials (RCTs) of interventions in SARS‐CoV‐2 infection published in five selected journals during 2021.MethodsWe assessed pharmacological interventions for SARS‐CoV‐2 infection reported in RCTs published in 2021 in the Annals of Internal Medicine, The BMJ, JAMA, The Lancet, and The New England Journal of Medicine for compliance with TIDieR items addressing intervention adherence (items 11 and 12). We calculated proportional adherence for pharmacological and comparator interventions where available.ResultsWe found 75 eligible RCTs. 28 (37%) reported results of SARS‐CoV‐2 vaccinations. Compliance with items 11 and 12 could be assessed in 71 of these 75. Of the 71 RCTs, 37 (52%) reported how adherence was assessed (item 11) and 70 reported adherence rates (item 12). Only one of the 71 RCTs (1.4%, 0–7.6%) fully complied with TIDieR items 11and 12.ConclusionsHalf of RCTs of SARS‐CoV‐2 pharmacological interventions published in leading medical journals in 2021 complied with reporting of how adherence assessments were made and almost none complied with both TIDieR items 11 and 12. The implications for interpretation, application, and replication of findings based on these publications warrant consideration.