Background: Throughout a medical product's life‐cycle, decisions about its use are evaluated as a balance between patients' anticipated benefits and risks. While both qualitative and quantitative methodologies have been developed to assess benefit‐risk, these methods may not be included in the abstracts of medical device literature, or studies may inappropriately designate findings as “benefit‐risk.”
Objectives: To review the medical device literature and evaluate how benefit‐risk is reported across various therapeutic areas.
Methods: Using MeSH terms for a broad capture, PubMed was searched for English language articles published in 2017 in which IMI‐PROTECT benefit‐risk methodologies were employed for medical devices.
Results: Among 218 abstracts, 96 (44%) were excluded due to inapplicability (not a primary study or not device research), and 64 (29%) were excluded because “benefit‐risk” was mentioned only in the introduction or conclusion. A total of 58 abstracts across 13 therapeutic areas were identified as reporting a benefit‐risk assessment. The majority (76%) used qualitative frameworks (22% quantitative). The predominant therapeutic areas were cardiovascular (CV, 50%) and oncology (10%). Oncology studies more often described quantitative frameworks (33%) compared with CV (21%) and other therapeutic areas (OTA, 22%). Oncology studies relied on registries, cohorts, and chart review (83%) more often than CV (72%) and OTA (50%). No oncology studies claiming to assess benefit‐risk were randomized trials, while 20% of CV and 10% of OTA studies used randomized designs. The framework was inferred for all oncology studies. Conversely, 10% CV and 4% OTA sufficiently described methodology to define framework.
Conclusions: Current trends indicate the term “benefit‐risk” is used broadly across medical device publications, with little context given to methodology. The lack of detail leaves the reader to wonder if and which benefit‐risk assessment was conducted. Differences observed across therapeutic areas further limit interpretation. Oncology studies most often employed quantitative frameworks. CV studies provided more study design information and included more randomized studies, but also more often reported qualitative methodologies. Lack of standardization in reporting across therapeutic areas limits interpretation of “benefit‐risk” for medical devices.