NESTcc Advances Data Quality and Study Design Frameworks
The National Evaluation System for health Technology Coordinating Center (NESTcc) on Tuesday unveiled two frameworks on data quality principles and study design methods for medical devices.The data quality framework is intended to serve as a guide to support high quality device data among NESTcc network collaborators and other organizations, whereas the methods framework serves as a “living playbook” for NESTcc to promote pre-specifications in prospective studies.
The data quality framework focuses on real-world data (RWD) from electronic health records (EHRs), although other RWD sources, such as registries, fall outside its scope. The principles of the methods framework are applicable to both observational and randomized benefit-risk studies.
Both frameworks are intended to be mutually complementary. As such, the methods framework banks on the assumption that data in proposed study protocols have been reliably tested for use.
“Data and information should be viewed as a continuum, capable of developing evidence over the total product life cycle (TPLC) of a device or procedure,” says NESTcc, coinciding with CDRH’s new push for TPLC. “Improving data quality at the point of care and point of data entry should be the ultimate goal.”
The five “topics most salient to achieving the highest data quality around medical devices” include governance, data characteristics, data capture and transformation, data curation as well as the newly proposed NESTcc Data Quality Maturity Model, according to the data quality framework.
NESTcc also says that the data quality framework’s next iteration will include the “NESTcc Data Quality Self-Evaluation, a checklist that charts the specific actions organizations can take to move between stages of the maturity model.” It invites “further discussion about how the framework can be operationalized by health systems, given the variability in maturity among individual clinics that compose a health system.”
The methods framework identifies 12 components of a study protocol, including device description, study-specific objectives, target population and patient selection, among others.
“This document, denoted the study protocol, describes fundamental features of study design that are precisely defined at an early stage, namely prior to statistical analyses,” says NESTcc.
NESTcc’s public comment period on the data quality and study design methods frameworks is set to close on 21 June.
Background
NESTcc began accepting requests for use of its data network earlier this year, following the January release of its “strategic and operational plan for 2019” to serve as the “front door to conduct RWE studies.” An active surveillance task force was established shortly thereafter and is charged with developing a blueprint by Spring 2019 for the launch of NESTcc’s first active surveillance projects.
CDRH, meanwhile, has continued to count on NEST becoming fully operational for other initiatives in addition to that of the TPLC approach. These include the work on a medical device single review program and global harmonization, as well as the agency’s Medical Device Safety Action Plan.