Regulators and payers expect examination of benefit-risk for medical products throughout the product life-cycle. A compendium of methodologies have been described for analyzing benefit-risk, including both qualitative and quantitative approaches. Despite the myriad methods available, we anticipate that many researchers do not consistently report their analyses of “benefit-risk”. We reviewed abstracts published in 2017 to elucidate current use of the term “benefit-risk” specifically in medical device literature.
We searched for “benefit-risk” using the terminology in the IMI-PROTECT analysis of benefit-risk methods and included a broad capture for medical devices via MeSH terms. We reviewed titles and English language abstracts published in Pubmed in 2017. Data extraction included the following elements: therapeutic area, type of benefit-risk analysis, study design, type of device, and intended audience of research. Descriptive analyses were performed.
Of 218 unique abstracts identified, 58 studes were included for assessment after exclusion criteria applied (78 not primary clinical studies, 64 mentioned “benefit-risk” only in the introduction or conclusions, 18 not device research). Most (76%) included descriptive frameworks (e.g., PrOACT-URL, 5%) . Quantitative frameworks (e.g., MDCA, 7%) were used in 24%. However, methodology was inferred (not explicitly stated) in 92% of abstracts and unable to be determined in 2%. Most studies were cohorts (62%), retrospective (60%), and were intended for clinical (97%) and/or regulatory (62%) audiences. Cardiovascular (45%) and oncology (10%) therapeutic areas were most commonly assessed. Compared to the average, studies of implants and cardiovascular devices were more likely to use qualitative frameworks while active/electronic and oncology devices were more likely to use quantitative methods.
Publications from 2017 highlight use of the term “benefit-risk” across a broad spectrum of analyses and study designs, leaving readers to extrapolate methodology. Differences were noted by device type. Clarity and standardization is needed in reporting studies of device benefit-risk.
PMD93 - Reporting of "Benefit-Risk" studies for medical devices in published literature