Ethical Considerations for Increased Transparency and Reproducibility in the Retrospective Analysis of Health Care Data.

In the field of health care, researchers and decision makers are increasingly turning toward retrospective observational studies of administrative claims and electronic health record databases to improve outcomes for patients. For many important questions, randomized studies have not been conducted, and even when they have been, such studies often inadequately reflect the realities of patients' lives or care. However, use of retrospective studies not only increases methodological complexity but also requires more subjectivity for those attempting to perform statistical analysis. The hurdles for establishing the reproducibility of such research to ensure accuracy and generalizability are therefore also higher, as are the requirements for transparency to limit the impact of bias. The ethical statistical practitioner will therefore need to take additional steps to enable results to be interpreted and acted upon with confidence. These include increased transparency regarding the impact of database selection, database quality, database content, and design decisions on the robustness of statistical conclusions. A number of approaches to increase the reproducibility of retrospective health care research are also presented, along with some discussion regarding responsibilities of data owners, statistical practitioners, publishers, and users of results.