Finite-sample adjustments for comparing clustered adaptive interventions using data from a clustered SMART
arxiv(2024)
摘要
Adaptive interventions, aka dynamic treatment regimens, are sequences of
pre-specified decision rules that guide the provision of treatment for an
individual given information about their baseline and evolving needs, including
in response to prior intervention. Clustered adaptive interventions (cAIs)
extend this idea by guiding the provision of intervention at the level of
clusters (e.g., clinics), but with the goal of improving outcomes at the level
of individuals within the cluster (e.g., clinicians or patients within
clinics). A clustered, sequential multiple-assignment randomized trials
(cSMARTs) is a multistage, multilevel randomized trial design used to construct
high-quality cAIs. In a cSMART, clusters are randomized at multiple
intervention decision points; at each decision point, the randomization
probability can depend on response to prior data. A challenge in
cluster-randomized trials, including cSMARTs, is the deleterious effect of
small samples of clusters on statistical inference, particularly via estimation
of standard errors. This manuscript develops finite-sample adjustment
(FSA) methods for making improved statistical inference about the causal
effects of cAIs in a cSMART. The paper develops FSA methods that (i) scale
variance estimators using a degree-of-freedom adjustment, (ii) reference a t
distribution (instead of a normal), and (iii) employ a “bias corrected"
variance estimator. Method (iii) requires extensions that are unique to the
analysis of cSMARTs. Extensive simulation experiments are used to test the
performance of the methods. The methods are illustrated using the Adaptive
School-based Implementation of CBT (ASIC) study, a cSMART designed to construct
a cAI for improving the delivery of cognitive behavioral therapy (CBT) by
school mental health professionals within high schools in Michigan.
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