Core Variable Assessment Towards a National Evaluation Program (CATNIP)
Benjamin Fisher, MD, FDA (Benjamin.Fisher@fda.hhs.gov)
Deborah Fisher, MD, Duke Clinical Research Institute (DCRI) (email@example.com)
Katherine D Crothall, PhD, Aspire Bariatrics, Inc. (firstname.lastname@example.org)
Laura Eaton-Jankov, RN, BSN, CCRN-R, Apollo Endosurgery (Laura.Eaton@apolloendo.com)
MDEpiNet Key Advisors
Mitchell Krucoff, MD, Duke Clinical Research Institute (DCRI)
Rebecca Wilgus, RN, MSN, DCRI
The Core variable Assessment Towards 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 structure of CATNIP is based on the successful MDEpiNet work in the CV and PV device domain (PASSION CV).
CATNIP is designed to advance the foundational elements of a total product lifecycle (TPLC) approach for the evaluation of bariatric and metabolic weight-loss devices, focusing 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 one or more existing registries and health information technology (HIT) systems. Structured datasets will be extracted and validated for use on pre- and post-market assessments, quality improvement, and safety surveillance projects. The goal of the core minimum data set is to promote more informative, more efficient, less expensive avenues for both pre- and post-market assessment of gastrointestinal devices. The core minimum data set not only provides the basis for standards-based data collection instruments, but also encourages and supports interoperable data accrual from registries & EHR systems and analysis of datasets across trials evaluating different devices.
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.
Current activities include—
Project Sponsorship Opportunities: To contribute toward the phase I informatics work, please email MDEpiNet. Sponsors receive the following:
- Participation in and a voice during scheduled meetings
- Recognized as a supporter of the CATNIP initiative
- Recognition of the support (logo) on CATNIP materials
- Recognition of support at CATNIP educational outreach programs
- Meeting reports from working group sessions and pertinent information
White Papers: Report from the kick-off meeting held on July 29, 2016 at the FDA is in progress; meeting recordings and presentations are available here.
Working Group Membership: To join a CATNIP Working Group, please email MDEpiNet.
Initial data element abstraction: If you/your organization is interested in providing data collection instruments or other relevant sources of data elements that will inform the development of the CATNIP core data set, please email MDEpiNet.
The CATNIP Leadership Team sets direction, provides oversight and guidance, and facilitates stakeholder engagement & support for the CATNIP project. Representatives from the Leadership team will actively participate in the CATNIP Working Groups, author publications, and raise awareness for CATNIP at professional meetings and conferences. Working Group Chairs, when identified, will join the Leadership Team.
Current members include the CATNIP Principle Investigators and advisors from the MDEpiNet Public Private Partnership. Organizations represented include:
- Aspire Bariatrics
- Apollo Endovascular
- Duke Clinical Research Institute
- US Food and Drug Administration
Description of Phase I work
- CATNIP use cases
- Develop use cases that define the requirements for the CATNIP core data set
- Data element collection, abstraction, analysis and synthesis
- Collection of case report forms (and data element definitions) from registries, FDA databases, and other stakeholders. Note: Phase I involves only the exchange of case report forms or data collection instruments/questionnaires used to collect data. Patient‐level data will NOT be exchanged in Phase I!
- Abstract and synthesize data elements from available sources. The source of each data element will remain anonymous
- Analyze and document data element utilization within and across sources and CATNIP use cases
- Analyze & document similarities and differences in data element structure, definition, and permissible values (and their definitions)
- CATNIP core data element identification, definition, and technical specification
- Clinical expert review, feedback, and comments about data element and permissible value definitions
- Informatics review, feedback, and comments about data element selection and structure
- Review and comments by extended stakeholder groups (e.g., professional societies)
- Development of core metadata needed to support mapping to external data models, ontologies, or terminology sets; support implementation and adoption by registries and EHR systems; and support data integration processes (i.e., extraction, transfer, and loading (ETL) of CATNIP core datasets)
- Evaluate Unique Device Identifiers (UDIs) and standard device identification data in the Global Unique Device Identifiers (GUDID) database
Phase II will develop data extraction interoperability across electronic platforms 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!
Shuren, J., & Califf, R. M. (2016). Need for a National Evaluation System for Health Technology. Jama. doi:10.1001/jama.2016.8708
Morales, J.P., Cronenwett, J, Thatcher, R. (2016). Registry Assessment of Peripheral Interventional Devices (RAPID). Endovascular Today 15.8 (2016): 85-94.