Suboptimal Practices in Harm Reporting: A Meta-Epidemiological Study on Metrics, Recurrence and Exposure Duration in Clinical Trials.

Abstract

Objective: The CONSORT Harms 2022 statement emphasizes the necessity for clinical trials to clearly address the duration of follow-up and recurrence of adverse events in safety analysis, highlighting the importance of using appropriate measures for a comprehensive risk assessment. This study aimed to provide guidance on metrics in harm profile reporting and evaluating current practices in clinical trials against the CONSORT Harms 2022 recommendations.

Study design and setting: We have summarized characteristics of four reporting metrics-cumulative incidence rate, cumulative event rate, exposure-adjusted incidence rate, and exposure-adjusted event rate. To evaluate the current reporting patterns, we conducted a meta-epidemiological study of 116 clinical trials published in four top-tier medical journals from September 1, 2023, to December 31, 2023.

Results: The cumulative incidence rate was the most frequently used metric (81.03%), followed by a simple count (16.38%), exposure-adjusted event rate (3.45%), exposure-adjusted incidence rate (2.59%), and cumulative event rate (0.86%). 105 trials (91.38%) employed a single measure and 10 trials (8.62%) incorporated two different measures. Only 14 trials (12.07%) gave explicit evidence for the reporting of recurrent adverse events and 6 trials (5.17%) explicitly stated their rationale for not considering recurrence. Adjustments for exposure duration were notably absent in trials with unequal drop-out rates and exposure times.

Conclusion: Recurrence of adverse events and varied exposure duration were inadequately addressed in current practices. Future trials should adopt transparent and sophisticated metrics in reporting them to capture a multidimensional and reliable representation of harm profiles.