Subject-level matching for imbalance in cluster randomized trials with a small number of clusters. 2013

Andrew C Leon, and Hakan Demirtas, and Chunshan Li, and Donald Hedeker
Department of Psychiatry, Weill Cornell Medical College, New York, NY, USA.

In a cluster randomized controlled trial (RCT), the number of randomized units is typically considerably smaller than in trials where the unit of randomization is the patient. If the number of randomized clusters is small, there is a reasonable chance of baseline imbalance between the experimental and control groups. This imbalance threatens the validity of inferences regarding post-treatment intervention effects unless an appropriate statistical adjustment is used. Here, we consider application of the propensity score adjustment for cluster RCTs. For the purpose of illustration, we apply the propensity adjustment to a cluster RCT that evaluated an intervention to reduce suicidal ideation and depression. This approach to adjusting imbalance had considerable bearing on the interpretation of results. A simulation study demonstrates that the propensity adjustment reduced well over 90% of the bias seen in unadjusted models for the specifications examined.

UI MeSH Term Description Entries
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000092864 Suicide Prevention Specific strategies for averting suicides. These include mental HEALTH PROMOTION and monitoring PSYCHOLOGICAL WELL-BEING and other intervention programs targeting susceptible individuals. Suicide Awareness,Awareness, Suicide,Prevention, Suicide,Suicide Preventions
D000368 Aged A person 65 years of age or older. For a person older than 79 years, AGED, 80 AND OVER is available. Elderly
D013405 Suicide The act of killing oneself. Suicides
D016000 Cluster Analysis A set of statistical methods used to group variables or observations into strongly inter-related subgroups. In epidemiology, it may be used to analyze a closely grouped series of events or cases of disease or other health-related phenomenon with well-defined distribution patterns in relation to time or place or both. Clustering,Analyses, Cluster,Analysis, Cluster,Cluster Analyses,Clusterings
D016032 Randomized Controlled Trials as Topic Works about clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table. Clinical Trials, Randomized,Controlled Clinical Trials, Randomized,Trials, Randomized Clinical
D057216 Propensity Score Conditional probability of exposure to a treatment given observed covariates. Propensity Scores,Score, Propensity,Scores, Propensity

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