title: Development and evaluation of a study design typology for human research.
abstract: A systematic classification of study designs would be useful for researchers, systematic reviewers, readers, and research administrators, among others. As part of the Human Studies Database Project, we developed the Study Design Typology to standardize the classification of study designs in human research. We then performed a multiple observer masked evaluation of active research protocols in four institutions according to a standardized protocol. Thirty-five protocols were classified by three reviewers each into one of nine high-level study designs for interventional and observational research (e.g., N-of-1, Parallel Group, Case Crossover). Rater classification agreement was moderately high for the 35 protocols (Fleiss' kappa = 0.442) and higher still for the 23 quantitative studies (Fleiss' kappa = 0.463). We conclude that our typology shows initial promise for reliably distinguishing study design types for quantitative human research.
authors.affiliation: University of California, San Francisco, CA, USA.
authors.forename: Simona
authors.initials: S
authors.lastname: Carini
authors.forename: Brad H
authors.initials: BH
authors.lastname: Pollock
authors.forename: Harold P
authors.initials: HP
authors.lastname: Lehmann
authors.forename: Suzanne
authors.initials: S
authors.lastname: Bakken
authors.forename: Edward M
authors.initials: EM
authors.lastname: Barbour
authors.forename: Davera
authors.initials: D
authors.lastname: Gabriel
authors.forename: Herbert K
authors.initials: HK
authors.lastname: Hagler
authors.forename: Caryn R
authors.initials: CR
authors.lastname: Harper
authors.forename: Shamim A
authors.initials: SA
authors.lastname: Mollah
authors.forename: Meredith
authors.initials: M
authors.lastname: Nahm
authors.forename: Hien H
authors.initials: HH
authors.lastname: Nguyen
authors.forename: Richard H
authors.initials: RH
authors.lastname: Scheuermann
authors.forename: Ida
authors.initials: I
authors.lastname: Sim
mesh_terms: D002986:Clinical Trials as Topic / Q000145:classification*; D006805:Human Experimentation; D006801:Humans; D010865:Pilot Projects; D012107:Research Design