How to write a surgical clinical research protocol: literature review and practical guide

R. Rosenthal, J. Schäfer, M. Briel, H.C. Bucher, D. Oertli, S. Dell-Kuster

Status: Abgeschlossen Dauer: Juli 2012 - Jan. 2014

Clinical research in studies involving surgical interventions presents some specific challenges. On the basis of a literature search of methodological literature and on some cardinal published surgical trials and observational studies, a 10-step guide for developing a surgical clinical study protocol was developed. The practical guide outlines key methodological issues important when planning an ethically and scientifically sound research project involving surgical interventions, with the ultimate goal of providing high-level evidence relevant for healthcare decision making in surgery.

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