title: A review for clinical outcomes research: hypothesis generation, data strategy, and hypothesis-driven statistical analysis.
abstract: In recent years, more and more large, population-level databases have become available for clinical research. The size and complexity of these databases often present a methodological challenge for investigators. We propose that a "protocol" may facilitate the research process using these databases. In addition, much like the structured History and Physical (H&P) helps the audience appreciate the details of a patient case more systematically, a formal outcomes research protocol can also help in the systematic evaluation of an outcomes research manuscript.
authors.affiliation: Department of Surgery, University of California San Diego, 200 Arbor Drive, #8400, San Diego, CA 92103, USA. dchang1@ucsd.edu
authors.forename: David C
authors.initials: DC
authors.lastname: Chang
authors.forename: Mark A
authors.initials: MA
authors.lastname: Talamini
mesh_terms: D003627:Data Interpretation, Statistical; D016208:Databases, Factual; D006801:Humans; D017063:Outcome Assessment, Health Care; D012107:Research Design; D013514:Surgical Procedures, Operative