Introduction
Obesity is a public health epidemic affecting 42.4% (2017–2018) of US adults.1 Due to the chronic nature and wide spectrum of manifestations and comorbidities, obesity may not be amenable to just one treatment. Although the safety of these surgeries has markedly improved over the recent years, there continues to be a certain rate of comorbidities associated with bariatric operations.2 Meta-analysis studies have shown that the mortality rate 30 days post-surgery is 0.31%, while 17% of patients suffer from complications within 5 years of surgery.3 4 It is partly due to these reasons that only a small percentage of qualified candidates seek surgical treatment. The need for innovation and expansion of available treatment options is challenged by the heterogeneity of assessments and safety definitions needed to compare devices, rendering some procedures safer and more efficacious. An infrastructure supporting collection of structured, high-quality, real-world data could develop evidence for regulatory decisions more efficiently, thus promoting innovation and decreasing the burden of data collection on clinical practitioners.
As the market for obesity and bariatric surgery devices expands, the need to harness existing data elements emerging from national and international data sources becomes increasingly paramount. Understanding the importance of creating an interoperable infrastructure for gaining real-world evidence (RWE) while monitoring device evaluation and surveillance across the device life cycle, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), together in a cooperative agreement with the Medical Device Epidemiology Network (MDEpiNet), have put forth the effort of establishing Coordinated Registry Networks (CRNs).5 6 CRNs are interoperable, comprehensive, and organized data systems that aid in improving patient healthcare via continuous collection of the most relevant data and meaningful outcomes. They are a structured, common lexicon of data elements that adds quality and efficiency across study designs and develops device benefit/risk evidence.
In some device areas, quality registries capturing more than 95% of procedures performed in USA provide a basis for such CRN lexicon.7 8 In other areas where no such infrastructure yet exists, the precompetitive, collaborative development of a minimum core data structure has been the successful focus of National Evaluation System for health Technology (NEST) Demonstration Programs (which provide proof of concept for scalable approaches to evidence generation across device types and across the total life cycle of a product) such as MDEpiNet’s RAPID (Registry Assessment of Peripheral Interventional Devices),9 and CRNs such as WHT-CRN (Women’s Health Technology)6 10 and SPARED-CRN (The Study of Prostate Ablation Related Energy Devices).11 12
Comparably to these predicates, obesity device development is challenged by a diversity of patient phenotypes and of surgical procedures across medical practitioners. To reconcile the prodigious amounts of available data, a forum was held by the FDA and MDEpiNet to define, standardize and implement a set of minimum core data elements, which would allow for the development of a bariatric device evaluation system across different electronic data sources. Stakeholders from a wide range of affiliations were present to participate in discussions regarding the objectives of the meeting. The overall project envisioned a registry which would allow for comparative assessment of performance across technologies and trials. The longitudinal capture of registry data would provide valuable and actionable public health information by answering questions of long-term safety and effectiveness. An obesity CRN would provide relevant information regarding comorbidity occurrence, impact on patient quality of life and incidence outcome, while also addressing key MDEpiNet concepts such as infrastructure integration of real-world data, cost efficiency, and novel analytic methodologies.
Insights through the stages of developing a precompetitive collaboration of academic, regulatory, and industry stakeholders to produce a minimum core data structure report describes the formation of the GI-CRN as a model for leveraging real-world obesity device data.13