Individually Randomized Group Treatment Trials: A Critical Appraisal of Frequently Used Design and Analytic Approaches

Pals, Sherri L.; Murray, David M.; Alfano, Catherine M.; Shadish, William R.; Hannan, Peter J.; Baker, William L.

doi:10.2105/ajph.2007.127027

Cited by 104Statistical Methods in Clinical TrialsMeta-analysis and systematic reviewsStatistical Methods and Bayesian Inference

Individually Randomized Group Treatment Trials: A Critical Appraisal of Frequently Used Design and Analytic Approaches

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Pals, Sherri L., Murray, David M., Alfano, Catherine M., Shadish, William R., Hannan, Peter J., Baker, William L.·2008·American Journal of Public Health

DOI 10.2105/ajph.2007.127027PMC PMC2446464

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Abstract

Objectives. We reviewed published individually randomized group treatment (IRGT) trials to assess researchers’ awareness of within-group correlation and determine whether appropriate design and analytic methods were used to test for treatment effectiveness. Methods. We assessed sample size and analytic methods in IRGT trials published in 6 public health and behavioral health journals between 2002 and 2006. Results. Our review included 34 articles; in 32 (94.1%) of these articles, inappropriate analytic methods were used. In only 1 article did the researchers claim that expected intraclass correlations (ICCs) were taken into account in sample size estimation; in most articles, sample size was not mentioned or ICCs were ignored in the reported calculations. Conclusions. Trials in which individuals are randomly assigned to study conditions and treatments administered in groups may induce within-group correlation, violating the assumption of independence underlying commonly used statistical methods. Methods that take expected ICCs into account should be used in reexamining past studies and planning future studies to ensure that interventions are not judged effective solely on the basis of statistical artifacts. We strongly encourage investigators to report ICCs from IRGT trials and describe study characteristics clearly to aid these efforts.

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Additional elements for trial designs other than parallel group superiority trials are often not described in final trial reports and are infrequently specified in the protocol.
“Such elements are often not described in final trial reports,299 300 301 302 and they are infrequently specified in the protocol.303”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [299]

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Authors: Pals, S. L., Murray, D. M., Alfano, C. M., Shadish, W. R., Hannan, P. J., & Baker, W. L.
Affiliations: Centers for Disease Control and Prevention (US)
ORCID: Pals, Sherri L.
Murray, David M.
Alfano, Catherine M.
Baker, William L.
Venue: American Journal of Public Health
Publisher: American Public Health Association
Published: 2008-08
Volume: 98
Issue: 8
Pages: 1418-1424
ISSN: 0090-0036 (ISSN-L)
1541-0048
DOI: 10.2105/ajph.2007.127027
PMC: PMC2446464
OpenAlex: W2064994313
Cited by: 104
References: 70
Citations by year: 2026: 5 · 2025: 7 · 2024: 9 · 2023: 7 · 2022: 7 · 2021: 11 · 2020: 5 · 2019: 4 · 2018: 4 · 2017: 7 · 2016: 7 · 2015: 3 · 2014: 5 · 2013: 7 · 2012: 4
FWCI: 3.78
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: American Journal of Public Health (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
RePEc: Research Papers in Economics (submittedVersion)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods and Bayesian Inference
Keywords: within-group correlation, intraclass correlation coefficient, sample size determination, statistical analysis methods, cluster randomization, treatment effectiveness, public health interventions, behavioral health interventions, reporting quality
MeSH terms: Biometry, Data Interpretation, Statistical, Humans, Research Design, Public Health Practice, Randomized Controlled Trials as Topic, Sample Size

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Individually Randomized Group Treatment Trials: A Critical Appraisal of Frequently Used Design and Analytic Approaches

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