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Ann Intern Med. 2019 Mar 12. doi: 10.7326/M18-3079. [Epub ahead of print]

Graphical Depiction of Longitudinal Study Designs in Health Care Databases.

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Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (S.S., S.V.W.).
Aetion, New York, New York (J.A.R., W.M.).
Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts (J.S.B.).
RTI Health Solutions, Durham, North Carolina (K.J.R.).
Journal of Managed Care and Specialty Pharmacy, Alexandria, Virginia (L.H.).
European Medicines Agency, London, United Kingdom (P.A.).
U.S. Food and Drug Administration, Silver Spring, Maryland (G.D.).
The National Health Care Institute, Diemen, and Utrecht University, Utrecht, the Netherlands (W.G.).


Pharmacoepidemiologic and pharmacoeconomic analysis of health care databases has become a vital source of evidence to support health care decision making and efficient management of health care organizations. However, decision makers often consider studies done in nonrandomized health care databases more difficult to review than randomized trials because many design choices need to be considered. This is perceived as an important barrier to decision making about the effectiveness and safety of medical products. Design flaws in longitudinal database studies are avoidable but can be unintentionally obscured in the convoluted prose of methods sections, which often lack specificity. We propose a simple framework of graphical representation that visualizes study design implementations in a comprehensive, unambiguous, and intuitive way; contains a level of detail that enables reproduction of key study design variables; and uses standardized structure and terminology to simplify review and communication to a broad audience of decision makers. Visualization of design details will make database studies more reproducible, quicker to review, and easier to communicate to a broad audience of decision makers.


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