Incorrect Analyses of Cluster-Randomized Trials that Do Not Take Clustering and Nesting into Account Likely Lead to p -Values that Are Too Small
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In the Aceves-Martins et al. study, the estimated means were unbiased and valid, but the standard errors, confidence intervals, and p-values were incorrect.
“While the estimated means from the trial were unbiased and valid, the standard errors, confidence intervals, and p-values were incorrect.”
From Evaluation of the type I error rate when using parametric bootstrap analysis of a cluster randomized controlled trial with binary outcomes and a small number of clusters (2022) · cites this paper as [6]
In the main text (page not provided), the authors warn that Aceves-Martins et al.’s p-values could be severely miscalculated if clustering and nesting were ignored, and they give illustrative corrections. They do not establish that the trial’s reported values were incorrect: they ask the trial authors to clarify their analyses. Nor does the paper state that the estimated means were unbiased and valid or specifically assess the reported standard errors and confidence intervals. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn the Aceves-Martins et al. 2017 school-based cRCT, the analysis did not take clustering into account.
“As an illustration, in a school-based cRCT published in 2017 by Aceves-Martins et al. [20], we detected that the analysis did not take clustering into account [6].”
From Evaluation of the type I error rate when using parametric bootstrap analysis of a cluster randomized controlled trial with binary outcomes and a small number of clusters (2022) · cites this paper as [6]
In the main text (page not provided), the source raises concern that the Aceves-Martins et al. analysis may not have accounted for clustering and nesting. It explicitly says the trial authors did not specify whether or how they accounted for them, and calls the omission apparent rather than established. The citing sentence states that omission as a definite finding. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn the Aceves-Martins et al. study, clustering and nesting of students within schools was incorrectly ignored, which led to smaller p-values than if clustering and nesting had been properly taken into account.
“In the statistical analyses, clustering and nesting of students within schools was incorrectly ignored, which led to smaller p-values than what would have been obtained if clustering and nesting had been properly taken into account [6].”
From Evaluation of the type I error rate when using parametric bootstrap analysis of a cluster randomized controlled trial with binary outcomes and a small number of clusters (2022) · cites this paper as [6]
In the paper’s main text, the authors say that the Aceves-Martins analyses do not specify whether or how clustering and nesting were accounted for; they describe an apparent omission, not a confirmed one. They estimate that ignoring clustering could produce smaller p-values, but explicitly call their calculations crude approximations. The citing sentence presents both the omission and its effect as established facts. (LLM, conf=0.90)
Experimental — accuracy not yet measured
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Cites
1 retracted
Aceves-Martins, M., Llauradó, E., Tarro, L., Moriña, D., Papell-Garcia, I., Prades-Tena, J., Kettner-Høeberg, H., Puiggròs, F., Arola, L., Davies, A., et al. (2017) · Childhood Obesity · doi:10.1089/chi.2016.0216 · Cited by 29 · see citing works
RetractedConsort 2010 statement: extension to cluster randomised trials
Campbell, M. K., Piaggio, G., Elbourne, D. R., Altman, D. G., & for the CONSORT Group (2012) · BMJ · doi:10.1136/bmj.e5661 · Cited by 3,510 · see citing works
Methods in Social Epidemiology
Pollock, J. (2009) · Journal of Public Health · doi:10.1093/pubmed/fdp023 · Cited by 185 · see citing works
Correcting a Significance Test for Clustering
Hedges, L. V. (2007) · Journal of Educational and Behavioral Statistics · doi:10.3102/1076998606298040 · Cited by 118 · see citing works
Llauradó, E., Aceves‐Martins, M., Tarro, L., Papell-Garcia, I., Puiggròs, F., Arola, L., Prades‐Tena, J., Montagut, M., Fernández, C. M. M., Solà, R., et al. (2015) · BMC Public Health · doi:10.1186/s12889-015-1920-1 · Cited by 37 · see citing works
Masood, M., & Reidpath, D. D. (2016) · BMJ Open · doi:10.1136/bmjopen-2015-008173 · Cited by 28 · see citing works
Gray, H. L., Burgermaster, M., Tipton, E., Contento, I. R., Koch, P. A., & Noia, J. D. (2015) · Health Education & Behavior · doi:10.1177/1090198115598987 · Cited by 20 · see citing works
Casazza, K., & Allison, D. B. (2012) · Clinical Obesity · doi:10.1111/j.1758-8111.2012.00052.x · Cited by 18 · see citing works
Self-citationThe Need for Greater Rigor in Childhood Nutrition and Obesity Research
Wood, A. C., Wren, J. D., & Allison, D. B. (2019) · Archives of Pediatrics and Adolescent Medicine · doi:10.1001/jamapediatrics.2019.0015 · Cited by 12 · see citing works
Self-citationOn the Hedges Correction for a t -Test
VanHoudnos, N., & Greenhouse, J. B. (2016) · Journal of Educational and Behavioral Statistics · doi:10.3102/1076998616644990 · Cited by 2 · see citing works
Flagged first, then by citations
Research works printed but not linked: 1
- [1]1. Aceves-Martins M, Llaurado ´ E, Tarro L, et al. A school-based, peerled, social marketing intervention to engage spanish adolescents in a healthy lifestyle (''We Are Cool''-Som la Pera Study): A parallelcluster randomized controlled study. Child Obes 2017;13:300-313.
Cited by
Sorted by citations
Vorland, C. J., Brown, A. W., Dawson, J., Dickinson, S., Golzarri‐Arroyo, L., Hannon, B. A., Heo, M., Heymsfield, S. B., Jayawardene, W. P., Kahathuduwa, C. N., et al. (2021) · International Journal of Obesity · doi:10.1038/s41366-021-00909-z · Cited by 40 · see citing works
Self-citationInfluential methods reports for group-randomized trials and related designs
Murray, D. M. (2022) · Clinical Trials · doi:10.1177/17407745211063423 · Cited by 19 · see citing works
Aceves‐Martins, M., Llauradó, E., Tarro, L., Papell-Garcia, I., Prades‐Tena, J., Kettner-Høeberg, H., Puiggròs, F., Arola, L., Davies, A., Giralt, M., et al. (2022) · Childhood Obesity · doi:10.1089/chi.2021.0207 · Cited by 12 · see citing works
Jamshidi‐Naeini, Y., Brown, A. W., Mehta, T. S., Glueck, D. H., Golzarri‐Arroyo, L., Muller, K. E., Tekwe, C. D., & Allison, D. B. (2022) · Obesity · doi:10.1002/oby.23373 · Cited by 12 · see citing works
Self-citationGolzarri-Arroyo, L., Dickinson, S. L., Jamshidi-Naeini, Y., Zoh, R. S., Brown, A. W., Owora, A. H., Li, P., Oakes, J. M., & Allison, D. B. (2022) · Computer Methods and Programs in Biomedicine · doi:10.1016/j.cmpb.2022.106654 · Cited by 9 · see citing works
Self-citationDifferences in factors associated with anemia in Haitian children from urban and rural areas
Palacios, A. M., FREELAND-GRAVES, J. H., Dulience, S. J. L., Delnatus, J. R., & Iannotti, L. L. (2021) · PLoS ONE · doi:10.1371/journal.pone.0247975 · Cited by 10 · see citing works
Cunningham-Sabo, L. D., Lohse, B., Nigg, C. R., & Parody, R. J. (2023) · Journal of Nutrition Education and Behavior · doi:10.1016/j.jneb.2022.10.008 · Cited by 4 · see citing works
Causal models and causal modelling in obesity: foundations, methods and evidence
Zoh, R. S., Yu, X. D., Dawid, A. P., Smith, G. D., French, S., & Allison, D. B. (2023) · Philosophical Transactions of the Royal Society B Biological Sciences · doi:10.1098/rstb.2022.0227 · Cited by 4 · see citing works
Self-citationPalacios, A. M., Villanueva, L. M., Flynn, M., Parker, E. S., Dickinson, S., Bland, H. W., & Reinhart, G. A. (2022) · Nutrients · doi:10.3390/nu14071366 · Cited by 2 · see citing works
Aceves‐Martins, M., Llauradó, E., Tarro, L., Moriña, D., Papell-Garcia, I., Prades‐Tena, J., Kettner-Høeberg, H., Puiggròs, F., Arola, L., Davies, A., et al. (2020) · Childhood Obesity · doi:10.1089/chi.2019.0265 · Cited by 2 · see citing works
Palacios, A. M., Keko, M., Rochani, H. D., Nazaruk, D., Aslan, A., Tome, J., Mayo‐Gamble, T. L., Ramos, G., & Manship, L. (2024) · PLoS ONE · doi:10.1371/journal.pone.0312825 · Cited by 1 · see citing works
(2020) · Childhood Obesity · doi:10.1089/chi.2016.0216.retract
Retracted
- Authors
- Golzarri-Arroyo, L., Oakes, J. M., Brown, A. W., & Allison, D. B.
- Affiliations
- School of Public Health, Indiana University—Bloomington, Bloomington, IN.
- University of Minnesota (US)
- Indiana University Bloomington (US)
- Corresponding author
- Allison, David B.
- Venue
- Childhood Obesity
- Publisher
- SAGE Publications
- Published
- 2020-03-01
- Volume
- 16
- Issue
- 2
- Pages
- 65-66
- ISSN
- 2153-2168 (ISSN-L)
- 2153-2176
- PMC
- PMC7047086
- OpenAlex
- W3007660320
- Cited by
- 12
- References
- 10
- Citations by year
- 2024: 1 · 2023: 2 · 2022: 5 · 2021: 2 · 2020: 2
- FWCI
- 1.94
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Childhood Obesity (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- IUScholarWorks Open (Indiana University) (submittedVersion)
- Funders
- National Heart, Lung, and Blood Institute (R25HL124208)
- National Institute of Diabetes and Digestive and Kidney Diseases (R25DK099080)
- 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
- clustering, nesting, p-values, statistical power, type I error, analytical methods
- MeSH terms
- Healthy Lifestyle, Adolescent, Humans, Research Design, Cluster Analysis, Randomized Controlled Trials as Topic, Social Marketing, Pediatric Obesity
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