Issues in the meta-analysis of cluster randomized trials
Abstract
Meta-analyses involving the synthesis of evidence from cluster randomization trials are being increasingly reported. These analyses raise challenging methodologic issues beyond those raised by meta-analyses which include only individually randomized trials. In this paper we review and comment on a selected number of these issues, including problems of study heterogeneity, difficulties in estimating design effects from individual trials and the choice of statistical methods.
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Cluster randomisation can overestimate treatment effect significance and inflate the nominal type I error rate unless clustering is properly adjusted for.
“Cluster randomisation, for example by clinician or practice, can lead to overestimation of the significance of a treatment effect, resulting in an inflation of the nominal type I error rate, unless appropriate adjustment is made for the effects of clustering (Donner 2002;Kerry 1998).”
From Interventions for self-harm in children and adolescents (2021) · cites this paper as Donner 2002
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Chakrabarti, A., Bagnall, A., Chue, P. S., Fenton, M., Palanisamy, V., Wong, W., & Xia, J. (2007) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd001943.pub2 · Cited by 222 · see citing works
Haloperidol plus promethazine for psychosis-induced aggression
Huf, G., Alexander, J., Allen, M. H., & Raveendran, N. S. (2009) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd005146.pub2 · Cited by 223 · see citing works
Paliperidone Palmitate for Schizophrenia
Nussbaum, A. M., & Stroup, T. S. (2012) · Schizophrenia Bulletin · doi:10.1093/schbul/sbs099 · Cited by 219 · see citing works
Interventions to improve return to work in depressed people
Nieuwenhuijsen, K., Verbeek, J. H. A. M., Neumeyer‐Gromen, A., Verhoeven, A. C., Bültmann, U., & Faber, B. (2020) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006237.pub4 · Cited by 221 · see citing works
Foy, R., Hempel, S., Rubenstein, L., Suttorp, M., Seelig, M., Shanman, R., & Shekelle, P. (2010) · Annals of Internal Medicine · doi:10.7326/0003-4819-152-4-201002160-00010 · Cited by 213 · see citing works
Thioridazine for schizophrenia
Fenton, M., Rathbone, J., & Reilly, J. G. (2007) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd001944.pub2 · Cited by 210 · see citing works
Sulpiride augmentation for schizophrenia
Wang, J., Omori, I. M., Fenton, M., & Soares, B. G. (2010) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd008125.pub2 · Cited by 206 · see citing works
Screening and case finding instruments for depression
Gilbody, S., House, A., & Sheldon, T. (2005) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd002792.pub2 · Cited by 205 · see citing works
Amisulpride versus other atypical antipsychotics for schizophrenia
Komossa, K., Rummel‐Kluge, C., Hunger, H., Schmid, F., Schwarz, S., Neto, J. I. S. D. M., Kissling, W., & Leucht, S. (2010) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006624.pub2 · Cited by 205 · see citing works
Oral paliperidone for schizophrenia
Nussbaum, A. M., & Stroup, T. S. (2008) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006369.pub2 · Cited by 195 · see citing works
Depot perphenazine decanoate and enanthate for schizophrenia
David, A. S., Quraishi, S. N., & Rathbone, J. (2005) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd001717.pub2 · Cited by 196 · see citing works
Depot fluphenazine decanoate and enanthate for schizophrenia
David, A. S., Adams, C. E., Eisenbruch, M., Quraishi, S. N., & Rathbone, J. (2003) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd000307 · Cited by 195 · see citing works
Quetiapine versus typical antipsychotic medications for schizophrenia
Suttajit, S., Srisurapanont, M., Xia, J., Suttajit, S., Maneeton, B., & Maneeton, N. (2013) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd007815.pub2 · Cited by 192 · see citing works
Pimozide for schizophrenia or related psychoses
Rathbone, J., & McMonagle, T. (2007) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd001949.pub2 · Cited by 191 · see citing works
Wang, Y., Xia, J., Helfer, B., Li, C., & Leucht, S. (2016) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd004028.pub4 · Cited by 188 · see citing works
Molindone for schizophrenia and severe mental illness
Bagnall, A., Fenton, M., Kleijnen, J., & Lewis, R. A. (2007) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd002083.pub2 · Cited by 188 · see citing works
Supported employment for adults with severe mental illness
Kinoshita, Y., Furukawa, T. A., Omori, I. M., Watanabe, N., Marshall, M., Bond, G. R., Huxley, P. J., & Kingdon, D. (2010) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd008297 · Cited by 188 · see citing works
Clozapine versus other atypical antipsychotics for schizophrenia
Lobos, C. A., Komossa, K., Rummel‐Kluge, C., Hunger, H., Schmid, F., Schwarz, S., & Leucht, S. (2010) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006633.pub2 · Cited by 187 · see citing works
Chlorpromazine dose for people with schizophrenia
Liu, X., & Haan, S. D. (2009) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd007778 · Cited by 187 · see citing works
Supported employment for adults with severe mental illness
Kinoshita, Y., Furukawa, T. A., Kinoshita, K., Honyashiki, M., Omori, I. M., Marshall, M., Bond, G. R., Huxley, P., Amano, N., & Kingdon, D. (2013) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd008297.pub2 · Cited by 182 · see citing works
Sertindole versus other atypical antipsychotics for schizophrenia
Komossa, K., Rummel‐Kluge, C., Hunger, H., Schwarz, S., Schmid, F., Lewis, R. A., Kissling, W., & Leucht, S. (2009) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006752.pub2 · Cited by 182 · see citing works
Music therapy for people with schizophrenia and schizophrenia-like disorders
Mössler, K. A., Chen, X., Heldal, T. O., & Gold, C. (2011) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd004025.pub3 · Cited by 188 · see citing works
Haloperidol for psychosis-induced aggression or agitation (rapid tranquillisation)
Ostinelli, E. G., Powney, M. J., Li, X., & Adams, C. E. (2017) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd009377.pub3 · Cited by 179 · see citing works
Sulpiride versus placebo for schizophrenia
Omori, I. M., & Wang, J. (2009) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd007811 · Cited by 173 · see citing works
Leucht, S., Helfer, B., Dold, M., Kissling, W., & McGrath, J. J. (2015) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003834.pub3 · Cited by 173 · see citing works
Cognitive Behavior Therapy Versus Other Psychosocial Treatments for Schizophrenia
Jones, C., Hacker, D., Cormac, I., Meaden, A., & Irving, C. B. (2012) · Schizophrenia Bulletin · doi:10.1093/schbul/sbs090 · Cited by 172 · see citing works
Intercessory prayer for the alleviation of ill health
Roberts, L., Ahmed, I., & Davison, A. (2009) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd000368.pub3 · Cited by 173 · see citing works
Chlorpromazine versus placebo for schizophrenia
Adams, C. E., Awad, G. A., Rathbone, J., Thornley, B., & Soares‐Weiser, K. (2014) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd000284.pub3 · Cited by 167 · see citing works
Benzodiazepines for schizophrenia
Dold, M., Li, C., Tardy, M., Khorsand, V., Gillies, D. M., & Leucht, S. (2012) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006391.pub2 · Cited by 169 · see citing works
Support for breastfeeding mothers: a systematic review
Sikorski, J., Renfrew, M. J., Pindoria, S., & Wade, A. M. (2003) · Paediatric and Perinatal Epidemiology · doi:10.1046/j.1365-3016.2003.00512.x · Cited by 166 · see citing works
Doherr, H., Christalle, E., Kriston, L., Härter, M. C., & Scholl, I. (2017) · PLoS ONE · doi:10.1371/journal.pone.0173904 · Cited by 165 · see citing works
Meta‐analysis of individual‐ and aggregate‐level data
Sutton, A. J., Kendrick, D., & Coupland, C. A. C. (2007) · Statistics in Medicine · doi:10.1002/sim.2916 · Cited by 162 · see citing works
Schwartze, D., Barkowski, S., Strauss, B. M., Knaevelsrud, C., & Rosendahl, J. (2017) · Psychotherapy Research · doi:10.1080/10503307.2017.1405168 · Cited by 166 · see citing works
Haloperidol versus placebo for schizophrenia
Adams, C. E., Bergman, H., Irving, C. B., & Lawrie, S. M. (2013) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003082.pub3 · Cited by 157 · see citing works
Gould, R. L., Coulson, M. C., Patel, N., Highton-Williamson, E., & Howard, R. J. (2014) · British Journal of Psychiatry · doi:10.1192/bjp.bp.113.126003 · Cited by 156 · see citing works
Hilton, M. P., Zimmermann, E. F., & Hunt, W. T. N. (2013) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003852.pub3 · Cited by 153 · see citing works
Aripiprazole versus other atypical antipsychotics for schizophrenia
Khanna, P., Suo, T., Komossa, K., Ma, H., Rummel-Kluge, C., El-Sayeh, H. G., Leucht, S., & Xia, J. (2014) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006569.pub5 · Cited by 151 · see citing works
Storebø, O. J., Skoog, M., Damm, D., Thomsen, P. H., Simonsen, E., & Gluud, C. (2011) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd008223.pub2 · Cited by 149 · see citing works
Interventions for self-harm in children and adolescents
Witt, K. G., Hetrick, S. E., Rajaram, G., Hazell, P., Taylor Salisbury, T. L., Townsend, E., & Hawton, K. (2021) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd013667.pub2 · Cited by 149 · see citing works
Santin, A. D., Bellone, S., Palmieri, M., Zanolini, A., Ravaggi, A., Siegel, E. R., Roman, J. J., Pecorelli, S. L., & Cannon, M. J. (2007) · Journal of Virology · doi:10.1128/jvi.02343-07 · Cited by 147 · see citing works
Pharmacological interventions for those who have sexually offended or are at risk of offending
Khan, O., Ferriter, M., Huband, N., Powney, M. J., Dennis, J. A., & Duggan, C. (2015) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd007989.pub2 · Cited by 144 · see citing works
Clozapine combined with different antipsychotic drugs for treatment-resistant schizophrenia
Barber, S., Olotu, U., Corsi, M., & Cipriani, A. (2017) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006324.pub3 · Cited by 144 · see citing works
White, I. R., & Thomas, J. (2005) · Clinical Trials · doi:10.1191/1740774505cn081oa · Cited by 143 · see citing works
Pharmacological interventions for people with borderline personality disorder
Binks, C., Fenton, M., McCarthy, L., Lee, T., Adams, C. E., & Duggan, C. F. (2006) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd005653 · Cited by 142 · see citing works
Polyunsaturated fatty acid supplementation for schizophrenia
Irving, C. B., Mumby-Croft, R., & Joy, L. A. (2006) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd001257.pub2 · Cited by 140 · see citing works
Psychological therapies for people with borderline personality disorder
Binks, C., Fenton, M., McCarthy, L., Lee, T., Adams, C. E., & Duggan, C. F. (2006) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd005652 · Cited by 140 · see citing works
Day hospital versus admission for acute psychiatric disorders
Marshall, M., Crowther, R., Sledge, W. H., Rathbone, J., & Soares-Weiser, K. (2011) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd004026.pub2 · Cited by 137 · see citing works
Sound therapy (using amplification devices and/or sound generators) for tinnitus.
Sereda, M., Xia, J., El Refaie, A., Hall, D. A., & Hoare, D. J. (2018) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd013094.pub2 · Cited by 135 · see citing works
Psychoeducation (brief) for people with serious mental illness
Zhao, S., Sampson, S. J., Xia, J., & Jayaram, M. (2015) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd010823.pub2 · Cited by 141 · see citing works
- Authors
- Donner, A., & Klar, N.
- Affiliations
- Western University (CA)
- Cancer Care Ontario (CA)
- Corresponding author
- Donner, Allan
- ORCID
- Klar, Neil
- Venue
- Statistics in Medicine
- Publisher
- Wiley
- Published
- 2002-09-20
- Volume
- 21
- Issue
- 19
- Pages
- 2971-2980
- ISSN
- 0277-6715 (ISSN-L)
- 1097-0258
- OpenAlex
- W2135029321
- Cited by
- 734
- References
- 58
- Citations by year
- 2026: 5 · 2025: 8 · 2024: 11 · 2023: 10 · 2022: 18 · 2021: 17 · 2020: 19 · 2019: 37 · 2018: 42 · 2017: 47 · 2016: 51 · 2015: 59 · 2014: 42 · 2013: 44 · 2012: 65
- FWCI
- 25.56
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Statistics in Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Keywords
- meta-analysis, study heterogeneity, statistical analysis, methodological issues
- MeSH terms
- Data Interpretation, Statistical, Humans, Research Design, Meta-Analysis as Topic, Cluster Analysis, Randomized Controlled Trials as Topic, Sample Size
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