Interplay between design and analysis for behavioral intervention trials with community as the unit of randomization : Community intervention trials.
This paper outlines an approach for the design and analysis of randomized controlled trials investigating community-based interventions for behavioral change aimed at health promotion.
The approach is illustrated using the Community Intervention Trial for Smoking Cessation (COMMIT), conducted from 1988 to 1993, involving 11 pairs of communities in North America, matched on geographic location, size, and sociodemographic factors.
The situation discussed is when assignment to intervention is done at the community level ; for COMMIT, the very nature of the intervention required this.
The number of communities is a key determinant of the statistical power of the trial.
The use of matched pairs of communities can achieve a gain in statistical efficiency.
Randomization is used to obtain an unbiased assessment of the intervention effect ; randomization also provides the basis for the statistical analysis.
Permutation tests (and corresponding test-based confidence intervals), using community as the unit of analysis, follow directly from the randomization distribution.
Within this framework, individual-level covariates can be used for imputation of missing values and for adjusting analyses of intervention effect.
Am J Epidemiol 1995 ; 142 : 587-93.
Mots-clés Pascal : Programme sanitaire, Communauté, Changement comportement, Sevrage toxique, Tabagisme, Randomisation, Analyse statistique, Essai clinique, Homme, Etats Unis, Promotion santé, Amérique du Nord, Amérique
Mots-clés Pascal anglais : Sanitary program, Community, Behavior change, Poison withdrawal, Tobacco smoking, Randomization, Statistical analysis, Clinical trial, Human, United States, Health promotion, North America, America
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Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 95-0508613
Code Inist : 002B30A03C. Création : 01/03/1996.