title: Designing clinical trials for NOTES.
abstract: This article breaks down the elements of designing clinical trials, with an emphasis on randomized controlled trials, as applied to advancing natural orifice translumenal endoscopic surgery research. It discusses research ethics, feasibility, design elements (such as randomization, blinding, and choosing a primary outcome), and issues regarding presentation of results. The pros and cons of subjective quality of life outcomes are debated, and the role of the patient/consumer in driving the direction and interpretation of clinical trials is discussed.
authors.affiliation: Digestive Disease Center, Department of Medicine, Division of Gastroenterology and Hepatology, Medical University of South Carolina, 25 Courteney Drive, ART 7100A, MSC 290, Charleston, SC 29425, USA. romagnuo@musc.edu
authors.forename: Joseph
authors.initials: J
authors.lastname: Romagnuolo
authors.forename: Peter
authors.initials: P
authors.lastname: Cotton
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D020776:Endoscopes, Gastrointestinal; D016099:Endoscopy, Gastrointestinal / Q000379:methods*; D019317:Evidence-Based Medicine; D005767:Gastrointestinal Diseases / Q000601:surgery; D006801:Humans; D012107:Research Design