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2014 ; 33
(13
): 2178-90
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Analytic methods for individually randomized group treatment trials and
group-randomized trials when subjects belong to multiple groups
#MMPMID24399701
Andridge RR
; Shoben AB
; Muller KE
; Murray DM
Stat Med
2014[Jun]; 33
(13
): 2178-90
PMID24399701
show ga
Participants in trials may be randomized either individually or in groups and may
receive their treatment either entirely individually, entirely in groups, or
partially individually and partially in groups. This paper concerns cases in
which participants receive their treatment either entirely or partially in
groups, regardless of how they were randomized. Participants in group-randomized
trials are randomized in groups, and participants in individually randomized
group treatment trials are individually randomized, but participants in both
types of trials receive part or all of their treatment in groups or through
common change agents. Participants who receive part or all of their treatment in
a group are expected to have positively correlated outcome measurements. This
paper addresses a situation that occurs in group-randomized trials and
individually randomized group treatment trials-participants receive treatment
through more than one group. As motivation, we consider trials in The Childhood
Obesity Prevention and Treatment Research Consortium, in which each child
participant receives treatment in at least two groups. In simulation studies, we
considered several possible analytic approaches over a variety of possible group
structures. A mixed model with random effects for both groups provided the only
consistent protection against inflated type I error rates and did so at the cost
of only moderate loss of power when intraclass correlations were not large. We
recommend constraining variance estimates to be positive and using the
Kenward-Roger adjustment for degrees of freedom; this combination provided
additional power but maintained type I error rates at the nominal level.