Adverse events in randomized controlled trials (RCTs) often suffer from inadequate reporting, which can significantly hinder the comprehensive evaluation of a treatment’s safety and efficacy. A recent update to the CONSORT harms checklist aims to address this issue by introducing a structured and consistent format for presenting adverse event data. This article proposes an extension to the checklist, suggesting that adverse events be reported alongside effectiveness outcomes to provide a holistic view of clinical trial results. This extension leverages benefit-risk methods that simultaneously consider both the benefits and risks of treatments, thereby enhancing the visibility and interpretation of adverse events.
Benefit-Risk Methods Explored
The article utilizes two RCTs, the Option-DM trial and the SANAD II trial, as case studies to demonstrate the practical application of benefit-risk methods in reporting adverse events. A shortlist of 17 potential benefit-risk methods was created based on a comprehensive review. From this list, three methods were selected: the Benefit-Risk Action Team (BRAT) Framework, net clinical benefit (NCB), and the Outcome Measures in Rheumatology (OMERACT) 3 × 3 table. These methods were chosen for their widespread use and their ability to fulfill the article’s objectives.
Case Study Results
In applying these benefit-risk methods to the Option-DM and SANAD II trials, the article illustrates how these methods add context and detail to the clinical summaries derived from the trials. For instance, in the SANAD II trial, although the primary outcome showed improvement with the treatment, the increase in adverse events led clinicians to recommend against the treatment. The benefit-risk methods provided a clear and transparent basis for this decision, highlighting the importance of presenting adverse event data alongside effectiveness outcomes.
Concrete Inferences for Practitioners
– Implementing benefit-risk methods in RCT reporting can offer a more comprehensive view of treatment impacts.
– Using structured frameworks like BRAT and OMERACT aids in transparent decision-making.
– Reporting adverse events alongside effectiveness outcomes ensures balanced clinical assessments.
In conclusion, incorporating benefit-risk methods into the reporting of RCTs can significantly improve the prominence and understanding of adverse event data. By presenting adverse events alongside primary efficacy outcomes, researchers and clinicians can make more informed decisions about the safety and effectiveness of treatments. This approach ensures that all factors influencing treatment recommendations are transparent and accessible to the reader.
Original Article: Trials. 2024 Jun 22;25(1):409. doi: 10.1186/s13063-024-08228-0.
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