Lorenz, Eva ORCID: 0000-0002-6057-0078, Koepke, Sascha, Pfaff, Holger ORCID: 0000-0001-9154-6575 and Blettner, Maria (2018). Cluster-Randomized Studies Part 25 of a Series on Evaluating Scientific Publications. Dtsch. Arztebl. Int., 115 (10). S. 163 - 169. COLOGNE: DEUTSCHER AERZTE-VERLAG GMBH. ISSN 1866-0452

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Background: Cluster-randomized trials (CRT) are needed to compare interventions that are allocated to entire groups of subjects, rather than to individuals. Publications about CRT have become steadily more common over the past decade. Readers of such publications should be able to categorize and interpret the findings of CRT correctly while considering the methodological requirements applicable to this type of study. Methods: This review is based on a selection of pertinent literature and on the authors' expertise. CRT-specific methodological aspects of the planning, performance, and interpretation of studies are discussed. Results: Readers of publications on CRT should check whether due consideration has been given to correlations within and between the clusters during the planning of the study. These correlations enable the determination whether persons within a cluster resemble each other more closely, or respond more similarly to the study intervention, than persons drawn from different clusters. It should also be checked whether the randomization for the study has been carried out with such methods as stratification and covariate-adjusted randomization. CRT can be analyzed on either the individual or the cluster level. The rationale for the choice of a cluster-randomized design should be explained, and intracluster correlation coefficients (ICC) should be reported as an aid to the planning of future studies. Particular requirements are also described in an extended version of the CONSORT guidelines that has been developed specifically for CRT. Conclusion: Readers of publications on CRT should be aware of the special requirements mentioned above with respect to the design, performance, and analysis of this type of study as opposed to individually randomized studies. If no special techniques are applied in the design, performance, and analysis of a CRT, or if the assumptions underlying each of these steps have not been properly checked, then the findings of the study may well be misleading.

Item Type: Journal Article
CreatorsEmailORCIDORCID Put Code
Lorenz, EvaUNSPECIFIEDorcid.org/0000-0002-6057-0078UNSPECIFIED
Pfaff, HolgerUNSPECIFIEDorcid.org/0000-0001-9154-6575UNSPECIFIED
URN: urn:nbn:de:hbz:38-192896
DOI: 10.3238/arztebl.2018.0163
Journal or Publication Title: Dtsch. Arztebl. Int.
Volume: 115
Number: 10
Page Range: S. 163 - 169
Date: 2018
Place of Publication: COLOGNE
ISSN: 1866-0452
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
Medicine, General & InternalMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/19289


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