Affiliation:
1. Scuola Superiore Sant'Anna
Abstract
Abstract
The increasing use of real-world evidence (RWE) and real-world data (RWD) to assess post-market Medical Devices (MDs) might satisfy the urgent need for data sharing and traceability. This study sought to i) get an overview of current practice in post-market assessments of MDs reporting on RWE/RWD; ii) draw policy recommendations for governments and health organizations and identify a research agenda for scholars. A systematic review was undertaken until July 2020 following the PRISMA guidelines. Original peer-reviewed articles in English and incorporating RWE/RWD into any sort of post-market assessment strategy for an MD were included and their reference lists manually checked. A narrative synthesis was employed to describe evidence retrieved. Totally, 103 research articles were identified. Administrative databases were mostly utilised; clinical and/or economic evidence gathered in a short/medium time horizon the most frequently reported; other evidence types (e.g., organizational) underreported; patient perspectives rarely incorporated; the innovation complexity of MDs relatively low. To our knowledge, this study is the first in its kind to provide a comprehensive picture of how non-randomized evidence has been used when assessing MDs working in real-life conditions. The implications of this review might help policy-makers to better understand the risks and benefits of medium and long-term use of MDs alongside clinical practice and make more informed decisions about adoption and use.
Publisher
Research Square Platform LLC
Reference160 articles.
1. Barlow J. Managing Innovation in Healthcare. World scientific publishing company, editor.; 2020.
2. Herzlinger RE. Why Innovation in Health Care Is So Hard.Harv Bus Rev. 2006;(May).
3. Roth M. 5 Issues Impeding Healthcare Innovation Progress. healthleaders; 2019.
4. Systematic review: The evidence that publishing patient care performance data improves quality of care;Fung CH;Ann Intern Med,2008
5. Loose connections between peer-reviewed clinical journals and clinical practice;Haynes RB;Ann Intern Med,1990