New frameworks for ensuring high-quality real-world evidence studies for medical devices
The National Evaluation System for Health Technology Assessment Coordinating Center (NESTcc; VA, USA) has published data quality and methods frameworks outlining principles for generating high-quality real-world evidence studies for medical devices.
The National Evaluation System for Health Technology Assessment Coordinating Center (NESTcc; VA, USA), an initiative of the Medical Device Innovation Consortium (VA, USA), has published data quality and methods frameworks. The guidelines, developed by expert stakeholders from academia, the US FDA and healthcare systems, outline principles for generating high-quality real-world evidence studies for medical devices.
Robbert Zusterzeel, Director of the NESTcc Data Network, stated: “The publication of the Data Quality and Methods Frameworks marks a key milestone for NESTcc…We’re excited to share this important work to help inform clinical and regulatory decision-making and support the health outcomes of people using medical devices.”
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The focus of the Data Quality Framework, the first of the two published guidelines, concerns the clinical use of electronic health record data; the document outlines principles important for the appropriate governance, capture and curation of these data.
Commenting on the potential of the Data Quality Framework, Lesley Curtis, Chair of the Department of Population Health Sciences at Duke University School of Medicine (NC, USA), explained: “The overarching goal of the framework is to enable the effective capture and use of device-related clinical information, which will ultimately, and most importantly, enable better care for patients.”
By contrast, the principles set out in the second Methods Framework are more widely applicable to studies in which various data sources may be employed, promoting fundamentally high-quality design, statistical analysis and procedures.
Sharon-Lise Normand (Harvard Medical School; MA, USA) commented: “These design practices for medical device evaluation aim to illuminate the path towards advances in safety, effectiveness, innovation, and transparency.”
Going forward, future development of the frameworks is planned to incorporate a greater variety of data sources, best practices guidelines and real-world evidence examples, to provide a more complete resource for use by relevant stakeholders of the medical device community.