Cited by 230Statistical Methods in Clinical TrialsStatistical Methods in EpidemiologyStatistical Methods and Bayesian Inference

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Statistical considerations in the design and analysis of community intervention trials

Donner, Allan, Klar, Neil·1996·Journal of Clinical Epidemiology

DOI 10.1016/0895-4356(95)00511-0

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Abstract

Community intervention trials are often characterized by the allocation of intact social units to different intervention groups. The assessment of adequate sample size for such trials must take into account the statistical dependencies among responses observed within an allocated unit. However, the small numbers of units typically involved in such trials imply that many methods of analysis that have been proposed for analyzing correlated data, particularly in the case of a dichotomous outcome variable, are not applicable to such designs. In this article we investigate this issue and determine the minimum number of units required per group, for the case of both a dichotomous and a continuous outcome variable, needed to provide adequate statistical power for detecting various levels of treatment effect. The use of significance testing as a method of detecting intracluster correlation is also investigated, and, in general, discouraged.

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Authors: Donner, A., & Klar, N.
Affiliations: Western University (CA)
ORCID: Klar, Neil
Venue: Journal of Clinical Epidemiology
Publisher: Elsevier BV
Published: 1996-04
Volume: 49
Issue: 4
Pages: 435-439
ISSN: 0895-4356 (ISSN-L)
DOI: 10.1016/0895-4356(95)00511-0
OpenAlex: W2050387573
Cited by: 230
References: 38
Citations by year: 2026: 3 · 2025: 1 · 2024: 2 · 2023: 2 · 2022: 10 · 2021: 6 · 2020: 10 · 2019: 7 · 2018: 13 · 2017: 16 · 2016: 8 · 2015: 12 · 2014: 8 · 2013: 8 · 2012: 9
FWCI: 6.47
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Journal of Clinical Epidemiology (publishedVersion)
PubMed (publishedVersion)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods and Bayesian Inference
Keywords: sample size determination, statistical power, intra-cluster correlation, binary outcomes, continuous outcomes, treatment effect detection
MeSH terms: Smoking Prevention, Adolescent, Clinical Trials as Topic, Humans, Random Allocation, Cluster Analysis, Sample Size

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Statistical considerations in the design and analysis of community intervention trials

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