Teaching Real-World Evidence: Protocol for a Systematic Review

BACKGROUND: Real-world evidence (RWE) refers to observational health care data beyond clinical trial data. It holds the promise of transforming health care as a new form of evidence to support decision makers in making decisions when developing and regulating medicines. As the importance of RWE is recognized by industry and regulatory bodies, teaching RWE becomes an important matter to evaluate and refine in order to develop future researchers and stakeholders who can better integrate RWE into the routine development of medicine. OBJECTIVE: The aim of this review is to understand how RWE is currently being taught. From this landscape study, the insufficiencies of the current education of RWE can be identified and subsequently inform future education policies around RWE and its subfacets. METHODS: We will search MEDLINE, EMBASE, PsycINFO, Healthcare Management Information Consortium, Cochrane, and Web of Science for published studies using a combination of keywords and subject headings related to RWE and education. In addition, a Google search to identify grey literature will be conducted. Two authors will independently screen the titles and abstracts identified from the search and accept or reject the studies according to the study inclusion criteria; any discrepancies will be discussed and resolved. The quality of the included literature will be assessed using the Critical Appraisal Skills Programme systematic review checklist. RESULTS: Data from eligible publications will be abstracted into a predesigned form in order to better understand the current state of education of RWE and inform future RWE education directions and policies. CONCLUSIONS: The subsequent systematic review will be published in a peer-reviewed journal. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/16941