title: How to write a surgical clinical research protocol: literature review and practical guide.
abstract: BACKGROUND
  The study protocol is the core document of every clinical research project. Clinical research in studies involving surgical interventions presents some specific challenges, which need to be accounted for and described in the study protocol. The aim of this review is to provide a practical guide for developing a clinical study protocol for surgical interventions with a focus on methodologic issues.
  
  
  METHODS
  On the basis of an in-depth literature search of methodologic literature and on some cardinal published surgical trials and observational studies, the authors provides a 10-step guide for developing a clinical study protocol in surgery.
  
  
  CONCLUSIONS
  This practical guide outlines key methodologic 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 health care decision making in surgery.
authors.affiliation: Department of Surgery, Basel University Hospital, Spitalstrasse 26, CH-4031 Basel, Switzerland. Electronic address: rachel.rosenthal@usb.ch.
authors.forename: Rachel
authors.initials: R
authors.lastname: Rosenthal
authors.affiliation: Department of Surgery, Basel University Hospital, Spitalstrasse 26, CH-4031 Basel, Switzerland; Basel Institute for Clinical Epidemiology and Biostatistics, Basel University Hospital, Basel, Switzerland.
authors.forename: Juliane
authors.initials: J
authors.lastname: Schäfer
authors.affiliation: Basel Institute for Clinical Epidemiology and Biostatistics, Basel University Hospital, Basel, Switzerland; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Matthias
authors.initials: M
authors.lastname: Briel
authors.affiliation: Basel Institute for Clinical Epidemiology and Biostatistics, Basel University Hospital, Basel, Switzerland.
authors.forename: Heiner C
authors.initials: HC
authors.lastname: Bucher
authors.affiliation: Department of Surgery, Basel University Hospital, Spitalstrasse 26, CH-4031 Basel, Switzerland.
authors.forename: Daniel
authors.initials: D
authors.lastname: Oertli
authors.affiliation: Department of Surgery, Basel University Hospital, Spitalstrasse 26, CH-4031 Basel, Switzerland; Basel Institute for Clinical Epidemiology and Biostatistics, Basel University Hospital, Basel, Switzerland.
authors.forename: Salome
authors.initials: S
authors.lastname: Dell-Kuster
mesh_terms: D035843:Biomedical Research / Q000379:methods*; D002985:Clinical Protocols / Q000592:standards*; D019317:Evidence-Based Medicine / Q000379:methods*; D013502:General Surgery / Q000379:methods*; D006801:Humans; D017410:Practice Guidelines as Topic / Q000592:standards*
keywords: Clinical research; Design; Study protocol; Surgery