Using baseline data to design a group randomized trial.
Group randomized trials (GRT) are often designed with relatively little preliminary data available to estimate key parameters. In this paper, however, the opposite situation is considered-very good baseline data are available on the primary outcome of interest. These data can then be used to inform key design and analysis decisions such as (i) should the trial be designed as an unmatched or pair-matched study, or stratified in some other fashion; (ii) is analysis of "change from baseline" preferable to using end-of-study data alone; and (iii) what power might be expected by pursuing these various strategies. The results are applied to a GRT for sexually transmitted diseases prevention in Peru.
Hughes
James P
JP
Department of Biostatistics, University of Washington, Seattle, WA 98195, U.S.A. jphughes@u.washington.edu
D003627:Data Interpretation, Statistical; D006801:Humans; D010568:Peru; D016032:Randomized Controlled Trials as Topic; D012107:Research Design / Q000706:statistics & numerical data*; D012749:Sexually Transmitted Diseases / Q000517:prevention & control