Design and Analytic Concepts for Periodontal Clinical Trials.

Autor: Imrey PB; Task Force on Design and Analysis, Inc. Lawrenceville, NJ.; Departments of Medical Information Science, Health and Safety Studies, and Statistics, and Center for Research on Oral Molecular Biology, University of Illinois, Urbana, IL., Chilton NW; Task Force on Design and Analysis, Inc. Lawrenceville, NJ.; Division of Biostatistics, School of Public Health, Columbia University, New York, NY.
Jazyk: angličtina
Zdroj: Journal of periodontology [J Periodontol] 1992 Dec; Vol. 63 Suppl 12S, pp. 1124-1140.
DOI: 10.1902/jop.1992.63.12s.1124
Abstrakt: Aspects of the design and analysis of periodontal clinical trials are surveyed from a biostatistical perspective. Design issues discussed include protocol preparation, subject selection and its documentation, randomization, problems associated with the sample versus population paradigm in sampling of microbes and gingival fluid constituents, quality control, cross-over and split-mouth versus parallel-arm designs, blinding, and multicenter trials. Analytic discussion deals with the definition and choice of analytic unit, appropriate methods for the analysis of data from multiple sites within the same subject, the nature and application of randomization tests, interim analyses, subgroup analyses, and multiple comparison issues. Examples are provided to illustrate the feasibility of analyzing site-specific data while accounting for intra-subject correlation, which represents the increased similarity of sites chosen from the same mouth as compared to sites from different patients. J Periodontol 1992; 63:1124-1140.
(© 1992 American Academy of Periodontology.)
Databáze: MEDLINE
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