{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T11:49:19Z","timestamp":1740138559157,"version":"3.37.3"},"reference-count":7,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2024,11,4]],"date-time":"2024-11-04T00:00:00Z","timestamp":1730678400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,2,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Cluster-randomized trials randomize entire groups of participants, instead of individual participants, to different treatment arms. For certain interventions (eg, institutional policies, processes of care, treatment algorithms), these designs protect against contamination between study arms. However, cluster trials are logistically complex to implement and have unique vulnerabilities that must be evaluated for accurate interpretation. Here, we provide a general overview of the design and statistical issues in cluster trials to facilitate their interpretation by clinicians.<\/jats:p>","DOI":"10.1093\/ibd\/izae256","type":"journal-article","created":{"date-parts":[[2024,11,4]],"date-time":"2024-11-04T13:59:58Z","timestamp":1730728798000},"page":"607-609","source":"Crossref","is-referenced-by-count":0,"title":["The Clinical Interpretation of Cluster Trials"],"prefix":"10.1093","volume":"31","author":[{"given":"Pavel S","family":"Roshanov","sequence":"first","affiliation":[{"name":"Division of Nephrology, Department of Medicine, Western University , London, ON ,","place":["Canada"]},{"name":"Department of Epidemiology and Biostatistics, Western University , London, ON ,","place":["Canada"]},{"name":"Lawson Health Research Institute , London, ON ,","place":["Canada"]},{"name":"Population Health Research Institute , Hamilton, ON ,","place":["Canada"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Guangyong","family":"Zou","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Biostatistics, Western University , London, ON ,","place":["Canada"]},{"name":"Robarts Research Institute , London, ON ,","place":["Canada"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8679-2541","authenticated-orcid":false,"given":"Reena","family":"Khanna","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Biostatistics, Western University , London, ON ,","place":["Canada"]},{"name":"Lawson Health Research Institute , London, ON ,","place":["Canada"]},{"name":"Division of Gastroenterology, Department of Medicine, Western University , London, ON ,","place":["Canada"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2024,11,4]]},"reference":[{"issue":"10006","key":"2025021012313016900_CIT0001","doi-asserted-by":"publisher","first-page":"1825","DOI":"10.1016\/S0140-6736(15)00068-9","article-title":"Early combined immunosuppression for the management of Crohn\u2019s disease (REACT): a cluster randomised controlled trial","volume":"386","author":"Khanna","year":"2015","journal-title":"Lancet."},{"issue":"6","key":"2025021012313016900_CIT0002","doi-asserted-by":"publisher","first-page":"906","DOI":"10.1093\/oxfordjournals.aje.a113261","article-title":"Randomization by cluster. Sample size requirements and analysis","volume":"114","author":"Donner","year":"1981","journal-title":"Am J Epidemiol."},{"issue":"5","key":"2025021012313016900_CIT0003","doi-asserted-by":"publisher","first-page":"479","DOI":"10.1111\/j.1365-2753.2005.00568.x","article-title":"Cluster randomized controlled trials","volume":"11","author":"Puffer","year":"2005","journal-title":"J Eval Clin Pract."},{"issue":"9","key":"2025021012313016900_CIT0004","doi-asserted-by":"publisher","first-page":"1439","DOI":"10.1002\/sim.5713","article-title":"Seven myths of randomisation in clinical trials","volume":"32","author":"Senn","year":"2013","journal-title":"Stat Med."},{"issue":"1","key":"2025021012313016900_CIT0005","doi-asserted-by":"publisher","first-page":"104","DOI":"10.1016\/s0895-4356(00)00286-9","article-title":"On stratification, minimization and protection against types 1 and 2 error","volume":"54","author":"Bracken","year":"2001","journal-title":"J Clin Epidemiol."},{"issue":"3","key":"2025021012313016900_CIT0006","doi-asserted-by":"publisher","first-page":"297","DOI":"10.1191\/1740774504cn024oa","article-title":"Covariate-based constrained randomization of group-randomized trials","volume":"1","author":"Moulton","year":"2004","journal-title":"Clin Trials."},{"issue":"1","key":"2025021012313016900_CIT0007","doi-asserted-by":"publisher","first-page":"21","DOI":"10.1186\/1471-2288-4-21","article-title":"Cluster randomised trials in the medical literature: two bibliometric surveys","volume":"4","author":"Bland","year":"2004","journal-title":"BMC Med Res Methodol."}],"container-title":["Inflammatory Bowel Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/ibdjournal\/article-pdf\/31\/2\/607\/60413054\/izae256.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ibdjournal\/article-pdf\/31\/2\/607\/60413054\/izae256.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,2,10]],"date-time":"2025-02-10T12:38:47Z","timestamp":1739191127000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/ibdjournal\/article\/31\/2\/607\/7874928"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,11,4]]},"references-count":7,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2024,11,4]]},"published-print":{"date-parts":[[2025,2,10]]}},"URL":"https:\/\/doi.org\/10.1093\/ibd\/izae256","relation":{},"ISSN":["1078-0998","1536-4844"],"issn-type":[{"type":"print","value":"1078-0998"},{"type":"electronic","value":"1536-4844"}],"subject":[],"published-other":{"date-parts":[[2025,2]]},"published":{"date-parts":[[2024,11,4]]}}}