Core Variable Assessment Towards a National Evaluation Program
Benjamin Fisher, MD, FDA (Benjamin.Fisher@fda.hhs.gov)
Deborah Fisher, MD, Duke Clinical Research Institute (DCRI) (firstname.lastname@example.org)
Katherine D Crothall, PhD, Aspire Bariatrics, Inc (email@example.com)
Laura Eaton-Jankov, RN, BSN, CCRN-R, Apollo Endosurgery (Laura.Eaton@apolloendo.com)
MDEpiNet Key Advisors
Mitchell Krucoff, MD, Duke Clinical Research Institute (DCRI)
Phase I Working Group Chairs
Project Management and Informatics Support
Rebecca Wilgus, RN, MSN, DCRI
The Core variable Assessment Towarrds a National evaluation Program (CATNIP) project emerged from the Predictable And SuStainable Implementation Of National (PASSION) Registries for Cardiovascular Devices program of the Medical Device Epidemiology Network (MDEpiNet), a public‐ private partnership supported by U.S. FDA funding to advance the nation’s approaches to the evaluation of medical devices. It is one project in a series initiated to advance and demonstrate the interoperable flow of data and information across electronic health information systems as a precursor to the National Evaluation System for Health Technology (NEST) articulated by Drs. Shuren and Califf. The MDEpiNet CATNIP project is designed to advance the foundational elements of a total product lifecycle (TPLC) approach for the evaluation of bariatric and metabolic weight-loss devices.
CATNIP is focused on endoscopically placed devices or procedures designed for weight loss and/or metabolic treatment (diabetes). The intent is to support the collection of structured, interoperable data at the point of care and make it available for use by patient registries, clinical research and medical device evaluation initiatives.
In Phase I, CATNIP will create a core set of standardized clinical data elements and Unique Device Identifiers (UDI) required to assess weight loss devices. In subsequent phases, these variables will be implemented in an existing registry and a structured dataset will be extracted and validated for use on pre- and post-market assessments, quality improvement, and safety surveillance projects.
The CATNIP core data elements will inform the development of standardized, electronic obesity-device data collection forms and instruments and utilized in a device evaluation study to demonstrate the value of the platform for industry, academia, and FDA.
Current participants in CATNIP include representatives of specialty societies, device manufacturers, electronic health information systems vendors, US FDA, and other federal partners.
Phase I will select data elements and definitions from existing data including the MBSAQIP registry and industry case report forms used for pivotal device approvals, and use these to create a global case report form, including primary and secondary outcome definitions. Note: This phase involves only the exchange and sharing of case report forms; it does not involve the exchange of actual, patient-level data that is collected with the forms.
More coming soon!
Phase II will develop data extraction interoperability across electronic platforms include the MBSAQIP registry and selected hospital EHRs (e.g. VA, Epic) that provide patient level data for core data elements.
More coming soon!
Phase III will conduct a device evaluation project within each electronic platform, leveraging the minimum core dataset, supporting a priority area of GI endoscopic clinical research and / or a regulatory decision.
More coming soon!