Cited by 298Statistical Methods in Clinical TrialsHealth Policy Implementation ScienceMeta-analysis and systematic reviews

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Sample Size Calculations for Cluster Randomised Trials

Campbell, Marion, Grimshaw, Jeremy, Steen, Nick, Changing Professional Practice in Europe Group (EU BIOMED II Concerted Action)·2000·Journal of Health Services Research & Policy

DOI 10.1177/135581960000500105

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Abstract

OBJECTIVES: Cluster randomised trials, in which groups of individuals are randomised, are increasingly being used in the health field. Adopting a clustered approach has implications for the design of such trials, and sample size calculations need to be inflated to accommodate for the clustering effect. Reliable estimates of intracluster correlation coefficients (ICCs) are required for robust sample size calculations to be made; however, little empirical evidence is available on their likely size, and on factors which influence their magnitude. The aim of this study was to generate empirical estimates of ICCs and to explore factors which may affect their magnitude. METHODS: Empirical estimates of ICCs were calculated for both process variables and patient outcomes from a number of datasets of primary and secondary care implementation studies. RESULTS: Estimates of ICCs varied according to setting and type of outcome. Estimates of ICCs for process variables were higher than those for patient outcomes, and estimates derived from secondary care were higher than those from primary care. ICCs for process variables in primary care were of the order of 0.05-0.15, whilst those in secondary care were of the order of 0.3. Estimates for patient outcomes in primary care were generally lower than 0.05. CONCLUSIONS: Adopting cluster randomisation has implications for the design, size and analysis of clinical trials. This study gives an insight into the potential size of ICCs in primary and secondary care, and provides a practical guide to researchers to aid the planning of future studies in this area.

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Retracted

Authors: Campbell, M., Grimshaw, J., Steen, N., & Changing Professional Practice in Europe Group (EU BIOMED II Concerted Action)
Affiliations: University of Aberdeen (GB)
Newcastle University (GB)
ORCID: Campbell, Marion
Grimshaw, Jeremy
Venue: Journal of Health Services Research & Policy
Publisher: SAGE Publications
Published: 2000-01
Volume: 5
Issue: 1
Pages: 12-16
ISSN: 1355-8196 (ISSN-L)
1758-1060
DOI: 10.1177/135581960000500105
OpenAlex: W170006779
Cited by: 298
References: 18
Citations by year: 2026: 5 · 2025: 5 · 2024: 5 · 2023: 8 · 2022: 7 · 2021: 14 · 2020: 13 · 2019: 14 · 2018: 9 · 2017: 11 · 2016: 17 · 2015: 14 · 2014: 23 · 2013: 11 · 2012: 23
FWCI: 12.89
Type: journal article
Language: en
Open access: closed
Licence: journals.sagepub.com/page/policies/text-and-data-mining-license (tdm)
Locations: Journal of Health Services Research & Policy (publishedVersion)
PubMed (publishedVersion)
Funders: Medical Research Council
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Keywords: sample size determination, intra-cluster correlation, cluster effect, primary care, secondary care, implementation research, process parameters, patient outcomes, trial design
MeSH terms: Europe, Health Services Research, Humans, Outcome and Process Assessment, Health Care, Sampling Studies, Cluster Analysis, Randomized Controlled Trials as Topic

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Sample Size Calculations for Cluster Randomised Trials

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