Ritchey ME, Hollis KA, Hauber AB, Gilsenan A, Krueger WS. Reporting of "Benefit-Risk" studies for medical devices in published literature. Poster to be given at the ISPOR 23rd Annual International Meeting; May 23, 2018. Baltimore, MD.


OBJECTIVES: 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.

METHODS: 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.

RESULTS: 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.

CONCLUSIONS: 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.

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