Harvard Medical School, Boston, USA
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Abstract: What does replicable ‘real world’ evidence from ‘real world’ data look like?
Regulatory and Health Technology Assessment (HTA) organizations are increasingly looking toward use of ‘real world’ evidence (RWE) from ‘real world’ data such as administrative claims and electronic health record databases to support decision-making. Ideal- ly, decision-makers want to focus on RWE that uses valid methodology, has transparent reporting, and generates reproducible evidence. However, published database studies frequently do not report on key im- plementation parameters, making it difficult to detect flaws in design or analysis. To increase confidence in use of RWE, decision-makers need the means to ef- fectively and efficiently distinguish between studies of high versus low validity. The REPEAT Initiative has projects focused on improving transparency, reprodu- cibility and validity of database research. These pro- jects include large scale replication of 150 published database studies, evaluation of robustness of results to alternative study parameters, and development of a structured reporting template with design visualizati- on to increase transparency of reporting and minimize misinterpretation.