Rationale, Methodological Quality, and Reporting of Cluster-Randomized Controlled Trials in Critical Care Medicine: A Systematic Review
Abstract
Objective Compared with individual-patient randomized controlled trials, cluster randomized controlled trials have unique methodological and ethical considerations. We evaluated the rationale, methodological quality, and reporting of cluster randomized controlled trials in critical care studies. Data sources Systematic searches of Medline, Embase, and Cochrane Central Register were performed. Study selection We included all cluster randomized controlled trials conducted in adult, pediatric, or neonatal critical care units from January 2005 to September 2019. Data extraction Two reviewers independently screened citations, reviewed full texts, protocols, and supplements of potentially eligible studies, abstracted data, and assessed methodology of included studies. Data synthesis From 1,902 citations, 59 cluster randomized controlled trials met criteria. Most focused on quality improvement (24, 41%), antimicrobial therapy (9, 15%), or infection control (9, 15%) interventions. Designs included parallel-group (25, 42%), crossover (21, 36%), and stepped-wedge (13, 22%). Concealment of allocation was reported in 21 studies (36%). Thirteen studies (22%) reported at least one method of blinding. The median total sample size was 1,660 patients (interquartile range, 813-4,295); the median number of clusters was 12 (interquartile range, 5-24); and the median patients per cluster was 141 (interquartile range, 54-452). Sample size calculations were reported in 90% of trials, but only 54% m…
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Both reporting and conduct might have improved in recent years with the use of the CONSORT statement extension for cluster randomized trials, but most evaluations of reporting and conduct suggest that improvements are minimal at best.
“Both reporting and conduct might have improved in recent years with the use of the CONSORT statement extension for cluster randomized trials [5], but most evaluations of reporting and conduct suggest that improvements are minimal at best [6].”
From Cluster randomized trials of individual-level interventions were at high risk of bias (2021) · cites this paper as [6]
Cites
Decontamination of the digestive tract and oropharynx in ICU patients
de Smet, A. M. G. A., Kluytmans, J. A. J. W., Cooper, B. S., Mascini, E. M., Benus, R. F. J., van der Werf, T. S., van der Hoeven, J. G., Pickkers, P., Bogaers-Hofman, D., van der Meer, N. J. M., et al. (2009) · New England Journal of Medicine · doi:10.1056/nejmoa0800394 · Cited by 813 · see citing works
A randomized trial of a family-support intervention in intensive care units
White, D. B., Angus, D. C., Shields, A.-M., Buddadhumaruk, P., Pidro, C., Paner, C., Chaitin, E., Chang, C.-C. H., Pike, F., Weissfeld, L., et al. (2018) · New England Journal of Medicine · doi:10.1056/nejmoa1802637 · Cited by 524 · see citing works
Curtis, J. R., Nielsen, E. L., Treece, P. D., Downey, L., Dotolo, D., Shannon, S. E., Back, A. L., Rubenfeld, G. D., & Engelberg, R. A. (2011) · American Journal of Respiratory and Critical Care Medicine · doi:10.1164/rccm.201006-1004oc · Cited by 269 · see citing works
Internal and external validity of cluster randomised trials: systematic review of recent trials
Eldridge, S., Ashby, D., Bennett, C., Wakelin, M., & Feder, G. (2008) · BMJ · doi:10.1136/bmj.39517.495764.25 · Cited by 224 · see citing works
for the MEDUSA study group, Bloos, F., Rüddel, H., Thomas-Rüddel, D., Schwarzkopf, D., Pausch, C., Harbarth, S., Schreiber, T., Gründling, M., Marshall, J., et al. (2017) · Intensive Care Medicine · doi:10.1007/s00134-017-4782-4 · Cited by 200 · see citing works
Ivers, N. M., Taljaard, M., Dixon, S., Bennett, C., McRae, A., Taleban, J., Skea, Z., Brehaut, J. C., Boruch, R. F., Eccles, M. P., et al. (2011) · BMJ · doi:10.1136/bmj.d5886 · Cited by 193 · see citing works
Wade, D. M., Mouncey, P. R., Richards-Belle, A., Wulff, J., Harrison, D. A., Sadique, M. Z., Grieve, R. D., Emerson, L. M., Mason, A. J., Aaronovitch, D., et al. (2019) · JAMA · doi:10.1001/jama.2019.0073 · Cited by 124 · see citing works
Parent, B., LaGrone, L. N., Albirair, M. T., Serina, P. T., Keller, J. M., Cuschieri, J., Addison, E. J., Choe, L., Delossantos, G. B., Gaskill, C. E., et al. (2018) · JAMA Surgery · doi:10.1001/jamasurg.2017.5440 · Cited by 46 · see citing works
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Cluster randomized trials of individual-level interventions were at high risk of bias
Easter, C., Thompson, J. A., Eldridge, S., Taljaard, M., & Hemming, K. (2021) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2021.06.021 · Cited by 34 · see citing works
- Authors
- Cook, D. J., Rutherford, W. B., Scales, D. C., Adhikari, N. K. J., & Cuthbertson, B. H.
- Affiliations
- Sunnybrook Health Science Centre (CA)
- Venue
- Critical Care Medicine
- Published
- 2021-02-12
- Volume
- 49
- Issue
- 6
- Pages
- 977-987
- ISSN
- 0090-3493 (ISSN-L)
- OpenAlex
- W3131991169
- Cited by
- 14
- References
- 8
- Citations by year
- 2026: 5 · 2025: 1 · 2024: 4 · 2022: 3 · 2021: 1
- FWCI
- 0.37
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Critical Care Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Canadian Institutes of Health Research
- 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
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Keywords
- intensive care, methodological quality, trial reporting, sample size determination, allocation concealment, blinding, intra-cluster correlation, stepped wedge design, crossover design, quality improvement intervention, infection control, antimicrobial therapy, neonatal intensive care, pediatric intensive care, adult intensive care, reporting bias, publication bias
- MeSH terms
- Critical Care, Humans, Research Design, Cluster Analysis, Randomized Controlled Trials as Topic
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