Clinical utility of overviews on adverse events of pharmacological interventions.

BACKGROUND: Overviews (i.e., systematic reviews of systematic reviews, meta-reviews, umbrella reviews) are a relatively new type of evidence synthesis. Among others, one reason to conduct an overview is to investigate adverse events (AEs) associated with a healthcare intervention. Overviews aim to provide easily accessible information for healthcare decision-makers including clinicians. We aimed to evaluate the clinical utility of overviews investigating AEs. METHODS: We used a sample of 27 overviews exclusively investigating drug-related adverse events published until 2021 identified in a prior project. We defined clinical utility as the extent to which overviews are perceived to be useful in clinical practice. Each included overview was assigned to one of seven pharmacological experts with expertise on the topic of the overview. The clinical utility and value of these overviews were determined using a self-developed assessment tool. This included four open-ended questions and a ranking of three clinical utility statements completed by clinicians. We calculated frequencies for the ranked clinical utility statements and coded the answers to the open-ended questions using an inductive approach. RESULTS: The overall agreement with the provided statements was high. According to the assessments, 67% of the included overviews generated new knowledge. In 93% of the assessments, the overviews were found to add value to the existing literature. The overviews were rated as more useful than the individual included systematic reviews (SRs) in 85% of the assessments. The answers to the open-ended questions revealed two key aspects of clinical utility in the included overviews. Firstly, it was considered useful that they provide a summary of available evidence (e.g., along with additional assessments, or across different populations, or in different settings that have not been evaluated together in the included SRs). Secondly, it was found useful if overviews conducted a new meta-analysis to answer specific research questions that had not been answered previously. CONCLUSIONS: Overviews on drug-related AEs are considered valuable for clinical practice by clinicians. They can make available evidence on AEs more accessible and provide a comprehensive view of available evidence. As the role of overviews evolves, investigations such as this can identify areas of value.

A review found heterogeneous approaches and insufficient reporting in overviews on adverse events.

OBJECTIVES: To investigate reporting and methodological characteristics of overviews on adverse (drug-associated) events (AEs) of pharmacological interventions. STUDY DESIGN AND SETTING: We searched MEDLINE, Embase, Epistemonikos, and the Cochrane Database of Systematic Reviews from inception to May 17, 2021 for overviews exclusively investigating AEs of pharmacological interventions. We extracted general, reporting, and methodological characteristics and analyzed data descriptively. RESULTS: We included 27 overviews, 70% of which were published in 2016 or later. The most common nomenclature in the title was "overview" (56%), followed by "umbrella review" (26%). The median number of included systematic reviews (SRs) in each overview was 15 (interquartile range 7-34). Study selection methods were reported in 52%, methods for data extraction in 67%, and methods for critical appraisal in 63% of overviews. An assessment of methodological quality of included SRs was performed in 70% of overviews. Only 22% of overviews reported strategies for dealing with overlapping SRs. An assessment of the certainty of the evidence was performed in 33% of overviews. CONCLUSION: To ensure methodological rigor, authors of overviews on AEs should follow available guidance for the conduct and reporting of overviews.