Reporting Quality of Randomized Controlled Trials in Antineutrophil Cytoplasmic Autoantibody–Associated Vasculitis

Abstract

Introduction: Treatment of anti-neutrophil cytoplasmic antibody–associated vasculitis (AAV) relies on high-quality randomized controlled trials (RCTs). Comprehensive and transparent reporting is crucial for the integrity and interpretation of trial findings. Consolidated Standards of Reporting Trials (CONSORT) checklists are part of a global initiative aiming to improve the quality of RCTs through standardized reporting. Reporting quality of AAV trials is unknown, thus we aimed to evaluate their adherence to CONSORT. Methods: A PubMed search for RCTs in AAV resulted in 596 hits. These were filtered to include only original RCTs published between January 2011 to March 2025. Adherence was calculated as the total percentage of all items applicable to the trial. Results: A total of 31 RCTs enrolling 3421 patients were included. Only 3 trials (10%) mentioned adherence to the CONSORT 2010 statement checklist, with only 1 including it as supplementary material. RCTs adhered to a median of 83% (interquartile range [IQR]: 77%–86%) CONSORT 2010 statement checklist items. Adherence was moderate (50%–75%) for 5 items and low (< 50%) for 6 items. There was no difference in adherence between industry-sponsored and other trials. Adherence was lowest from 2011 to 2013 (69%) but increased and remained between 79% and 86% afterward. RCTs had a mean adherence to CONSORT-Abstracts (CONSORT-A) of 73% ± 15% (min–max: 41%–94%). Conclusion: Although the overall adherence of RCTs in AAV to both CONSORT checklists is good, the reporting of some key items, such as randomization, blinding, adherence to trial protocol, and similarity of interventions is lacking.