Evaluation of the transparency of benefit-risk assessments of interventions in clinical practice Guidelines

Abstract

Evidence-based medicine (EBM) has become a fundamental pillar of everyday healthcare, creating a bridge between the best available evidence and current clinical practice. In this context, Clinical Practice Guidelines (CPGs) are key instruments as they simplify the implementation of evidence-supported practices. Unfortunately, however, difficulties persist in terms of transparency of the benefit-risk relationship assessment (BRRA) of interventions during CPG development, which can have a negative impact on CPGs quality and clarity and therefore on clinicians’ trust in and adherence to CPGs recommendations. OBJECTIVES The main objective of this study is to assess the transparency of the benefit-risk relationship assessment (BRRA) of interventions in current CPGs. METHODS A Transparency Score of the interventions in CPGs was developed. A descriptive cross-sectional study of the BRRA of interventions evaluated in CPGs using the Transparency Score developed was conducted. The influence of CPG-related covariates on the transparency of BRRA was studied. RESULTS A total of 50 CPGs from 4 different regions were included. One fifth (20%) of the CPGs had a suitable transparency of the RBA of the interventions evaluated. Transparency was associated positively with patient involvement, presence of EBM experts, use of a GRADE framework and, mostly, with the use of Evidence to Decision (EtD) framework. CONCLUSIONS: Transparency of the BRRA of treatment recommendations in CPGs is suboptimal, with critical areas for improvement. A wide between-CPG variability in the BRRA of interventions recommended was found. The inclusion of patients and EBM experts, and the use of GRADE and EtD frameworks are recommended in the development of future CPGs