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2018 ; 115
(10
): 163-168
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Cluster-Randomized Studies
#MMPMID29587960
Lorenz E
; Köpke S
; Pfaff H
; Blettner M
Dtsch Arztebl Int
2018[Mar]; 115
(10
): 163-168
PMID29587960
show ga
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 clusterrandomized 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.
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