Cited by 299Statistical Methods in Clinical TrialsStatistical Methods and Bayesian InferenceMeta-analysis and systematic reviews

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Design and analysis of clinical trials with clustering effects due to treatment

Roberts, Chris, Roberts, Stephen A·2005·Clinical Trials

DOI 10.1191/1740774505cn076oa

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Abstract

Where patients receive therapy as a group, there are good theoretical reasons to believe that variation in the outcome will be smaller for patients treated in the same group than for patients treated in different groups. Similarly, where different therapists treat different groups of patients, outcome for patients treated by the same therapist may differ less than outcome for patients treated by different therapists. Clinical trials evaluating such therapies need to consider this potential lack of independence. As with cluster-randomized trials, this has implications for the precision of treatment effects estimates and statistical power. There are nevertheless differences between clustering due to the organization of treatment and that due to randomization. In cluster-randomized trials the distribution of cluster sizes in each treatment arm should be similar as a consequence of randomization unless there is differential loss to follow-up. With clustering due to therapy group or therapist, cluster size may differ systematically between treatment arms, due to size of therapy groups or differing health professional caseload. Intra-cluster correlation may also differ between treatment arms. The implications of differential cluster size and intracluster correlation for design and analysis will be illustrated by data from two trials, the first comparing nurse practitioner care with general practitioner care, and the second comparing a group therapy with individual treatment as usua…

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Additional file 5 of Managing clustering effects and learning effects in the design and analysis of multicentre randomised trials: a survey to establish current practice
Conroy, E. J., Blazeby, J. M., Burnside, G., Cook, J. A., & Gamble, C. L. (2020) · Figshare · doi:10.6084/m9.figshare.12381137
Additional file 8 of Managing clustering effects and learning effects in the design and analysis of multicentre randomised trials: a survey to establish current practice
Conroy, E. J., Blazeby, J. M., Burnside, G., Cook, J. A., & Gamble, C. L. (2020) · Figshare · doi:10.6084/m9.figshare.12381146
Additional file 1 of PeRsOnaliSed care Planning for oldER people with frailty (PROSPER): protocol for a randomised controlled trial
Heaven, A., Bower, P., Day, F., Farrin, A., Fernadez, C., Foster, M., Foy, R., Hawkins, R., Hulme, C. T., Humphrey, S., et al. (2024) · Figshare · doi:10.6084/m9.figshare.24934126
Additional file 10 of Managing clustering effects and learning effects in the design and analysis of multicentre randomised trials: a survey to establish current practice
Conroy, E. J., Blazeby, J. M., Burnside, G., Cook, J. A., & Gamble, C. L. (2020) · Figshare · doi:10.6084/m9.figshare.12381110
Additional file 4 of Managing clustering effects and learning effects in the design and analysis of multicentre randomised trials: a survey to establish current practice
Conroy, E. J., Blazeby, J. M., Burnside, G., Cook, J. A., & Gamble, C. L. (2020) · Figshare · doi:10.6084/m9.figshare.12381131
Additional file 4 of Balance Right in Multiple Sclerosis (BRiMS): a feasibility randomised controlled trial of a falls prevention programme
Gunn, H., Stevens, K. N., Creanor, S., Andrade, J., Paul, L., Miller, L., Green, C., Ewings, P., Barton, A., Berrow, M., et al. (2021) · Figshare · doi:10.6084/m9.figshare.13515539
Additional file 6 of Managing clustering effects and learning effects in the design and analysis of multicentre randomised trials: a survey to establish current practice
Conroy, E. J., Blazeby, J. M., Burnside, G., Cook, J. A., & Gamble, C. L. (2020) · Figshare · doi:10.6084/m9.figshare.12381140
Additional file 3 of The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial
Nordlund, J., Henry, R. S., Kwakkenbos, L., Carrier, M.-E., Levis, B., Nielson, W. R., Bartlett, S. J., Dyas, L., Tao, L., Fedoruk, C., et al. (2021) · Figshare · doi:10.6084/m9.figshare.17088373
Additional file 12 of Managing clustering effects and learning effects in the design and analysis of multicentre randomised trials: a survey to establish current practice
Conroy, E. J., Blazeby, J. M., Burnside, G., Cook, J. A., & Gamble, C. L. (2020) · Figshare · doi:10.6084/m9.figshare.12381119
Additional file 1 of Home-based Extended Rehabilitation for Older people (HERO): study protocol for an individually randomised controlled multi-centre trial to determine the clinical and cost-effectiveness of a home-based exercise intervention for older people with frailty as extended rehabilitation following acute illness or injury, including embedded process evaluation
Prescott, M., Lilley-Kelly, A., Cundill, B., Clarke, D. J., Drake, S., Farrin, A. J., Forster, A., Goodwin, M., Goodwin, V. A., Hall, A. J., et al. (2021) · Figshare · doi:10.6084/m9.figshare.16960546
Additional file 2 of Managing clustering effects and learning effects in the design and analysis of multicentre randomised trials: a survey to establish current practice
Conroy, E. J., Blazeby, J. M., Burnside, G., Cook, J. A., & Gamble, C. L. (2020) · Figshare · doi:10.6084/m9.figshare.12381125
Additional file 1 of REACH-ASD: a UK randomised controlled trial of a new post-diagnostic psycho-education and acceptance and commitment therapy programme against treatment-as-usual for improving the mental health and adjustment of caregivers of children recently diagnosed with autism spectrum disorder
Leadbitter, K., Smallman, R. P., James, K., Shields, G., Ellis, C., Langhorne, S., Harrison, L., Hackett, L., Dunkerley, A., Kroll, L., et al. (2022) · Figshare · doi:10.6084/m9.figshare.20364885
Efficient design of partially nested randomized trials: A maximin approach
Candel, M. J. J. M., & van Breukelen, G. (2026) · Statistical Methods in Medical Research · doi:10.1177/09622802251409388
Impacts of Community-Based Rehabilitation on Healthcare Utilization and Costs Among People With Schizophrenia in China: A Cluster Randomized Controlled Trial
Ding, R., Zhao, M. H., Xia, Y., Wang, Y., Shi, Z., Hu, X., Ling, L., & He, P. (2026) · Schizophrenia Bulletin · doi:10.1093/schbul/sbag014
Estimation of comparable standardized mean differences in cluster randomized trials with covariate adjustment.
Jung, J., Liu, Z., & Aloe, A. M. (2026) · British Journal of Mathematical & Statistical Psychology · doi:10.1111/bmsp.70062
Design and monitoring of randomized trials in vision research with binary endpoints
Diao, G., Zhang, Q., Hamasaki, T., & Evans, S. R. (2026) · Clinical Trials · doi:10.1177/17407745261468235
Using the NIH Research Methods Resources Website
Murray, D. M., & Moyer, J. (2026) · Prevention Science · doi:10.1007/s11121-026-01955-7
Optimal Sample Allocation for Multisite Partially Nested Individual-Randomized Trials
Xie, Y., & Kelcey, B. M. (2026) · The Journal of Experimental Education · doi:10.1080/00220973.2026.2719484

Authors: Roberts, C., & Roberts, S. A.
Affiliations: University of Manchester (GB)
Corresponding author: Roberts, Chris
ORCID: Roberts, Stephen A
Venue: Clinical Trials
Publisher: SAGE Publications
Published: 2005-04
Volume: 2
Issue: 2
Pages: 152-162
ISSN: 1740-7745 (ISSN-L)
1740-7753
DOI: 10.1191/1740774505cn076oa
OpenAlex: W2093029291
Cited by: 299
References: 30
Citations by year: 2026: 8 · 2025: 14 · 2024: 16 · 2023: 18 · 2022: 14 · 2021: 23 · 2020: 33 · 2019: 23 · 2018: 13 · 2017: 11 · 2016: 14 · 2015: 12 · 2014: 22 · 2013: 12 · 2012: 17
FWCI: 4.50
Type: journal article
Language: en
Open access: closed
Licence: journals.sagepub.com/page/policies/text-and-data-mining-license (tdm)
Locations: Clinical Trials (publishedVersion)
PubMed (publishedVersion)
Research Explorer (The University of Manchester) (submittedVersion)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods and Bayesian Inference
Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Keywords: cluster effect, group therapy, therapist effects, intra-cluster correlation, statistical power, sample size, general practitioner care, simulation study
MeSH terms: Data Interpretation, Statistical, Group Processes, Humans, Nurse Practitioners, Physicians, Family, Research Design, Statistics as Topic, Cluster Analysis, Randomized Controlled Trials as Topic, Treatment Outcome, Sample Size

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Design and analysis of clinical trials with clustering effects due to treatment

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