Development and evaluation of a study design typology for human research.

Simona Carini, Brad H. Pollock, Harold P. Lehmann, Suzanne Bakken, Edward M. Barbour, Davera Gabriel, Herbert K. Hagler, Caryn R. Harper, Shamim A. Mollah, Meredith Nahm, Hien H. Nguyen, Richard H. Scheuermann, Ida Sim

    Research output: Contribution to journalArticle

    9 Scopus citations

    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.

    Original languageEnglish (US)
    Pages (from-to)81-85
    Number of pages5
    JournalAMIA ... Annual Symposium proceedings / AMIA Symposium. AMIA Symposium
    Volume2009
    StatePublished - 2009

    ASJC Scopus subject areas

    • Medicine(all)

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  • Cite this

    Carini, S., Pollock, B. H., Lehmann, H. P., Bakken, S., Barbour, E. M., Gabriel, D., Hagler, H. K., Harper, C. R., Mollah, S. A., Nahm, M., Nguyen, H. H., Scheuermann, R. H., & Sim, I. (2009). Development and evaluation of a study design typology for human research. AMIA ... Annual Symposium proceedings / AMIA Symposium. AMIA Symposium, 2009, 81-85.