Reporting of medication adherence in randomized controlled trials of pharmacological interventions for SARS-CoV-2: a cross-sectional analysis (preprint)

Background: Adherence to pharmacological interventions in clinical trials is crucial for correct estimation of beneficial and adverse effects, including trials of SARS-CoV-2. The Template for Intervention Description and Replication (TIDieR), a 12-item extension of the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines, includes two items (11 and 12) that address intervention adherence reporting in trial publications. Objective: To 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. Methods: We assessed SARS-CoV-2 pharmacological RCTs published in the Annals of Internal Medicine, The BMJ, JAMA, The Lancet, and The New England Journal of Medicine in 2021 for compliance with TIDieR items 11 and 12. Item 11 was assessed in two parts: 11a how intervention adherence was assessed; 11b if any strategies were used to maintain or improve how intervention adherence was maintained or improved. Item 12 assessed the extent to which the intervention was delivered as planned. We calculated raw adherence and proportional (weighted) adherence for pharmacological and comparator interventions where available. Results: We found 75 eligible RCTs, of which 28 (37%) reported results related to SARS-CoV-2 vaccinations. Compliance with items 11a and 12 could be assessed in 71 of these 75. Of those 71 RCTs, 37 (52%, 95% confidence interval 40 to 64%) were compliant with reporting of item 11a. Seven RCTs had a strategy to assess compliance with item 11b, and only three (43%, 9 to 82%) of those complied with item 11b reporting. Of the 71 RCTs, 70 complied with reporting of item 12. Only one of the 71 RCTs (1.4%, 0 to 7.6%) fully complied with TIDieR items 11a, 11b, and 12. Compliance varied across journals. Conclusions: RCTs of SARS-CoV-2 pharmacological interventions published in high-impact medical journals complied variably with reporting of intervention adherence, even though the journals endorse CONSORT. The implications for interpretation, application, and replication of findings based on these publications warrant consideration.

Open science policies of medical and health sciences journals before and during the COVID-19 pandemic: a repeat cross-sectional study (preprint)

Cross-disciplinary openness and transparency of research plays an important role in scientific progress. We evaluated open-science related policies of 19 high ranking health and medical journals before (February 2020) and during (May 2021) the COVID-19 pandemic. The Transparency and Openness Promotion (TOP) guideline and the International Committee of Medical Journal Editors (ICMJE) requirements for disclosing conflicts of interest (COIs) were used to audit journal policies. TOP scores slightly improved during the COVID-19 pandemic, from a median of 5 (IQR: 2-12.5) out of a possible 24 points in February 2020 to 7 (IQR: 4-12) in May 2021. Most journals fulfilled all ICMJE provisions for reporting COIs before (84%; n=16) and during (95%; n=18) the COVID-19 pandemic. The COVID-19 pandemic has highlighted the importance of practising open science, however adherence to open science standards in audited policies was low overall, which may reduce progress in health and medical research.