Open AccessImpact of complex, partially nested clustering in a three-arm individually randomized group treatment trial: A case study with the wHOPE trial
Author(s) -
Guangyu Tong,
Karen H. Seal,
William C. Becker,
Fan Li,
James Dziura,
Peter Peduzzi,
Denise Esserman
Publication year - 2021
Publication title -
clinical trials
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.559
H-Index - 63
eISSN - 1740-7753
pISSN - 1740-7745
DOI - 10.1177/17407745211051288
Subject(s) - intraclass correlation , randomized controlled trial , medicine , physical therapy , clinical trial , statistics , mathematics , clinical psychology , psychometrics , surgery , pathology
When participants in individually randomized group treatment trials are treated by multiple clinicians or in multiple group treatment sessions throughout the trial, this induces partially nested clusters which can affect the power of a trial. We investigate this issue in the Whole Health Options and Pain Education trial, a three-arm pragmatic, individually randomized clinical trial. We evaluate whether partial clusters due to multiple visits delivered by different clinicians in the Whole Health Team arm and dynamic participant groups due to changing group leaders and/or participants across treatment sessions during treatment delivery in the Primary Care Group Education arm may impact the power of the trial. We also present a Bayesian approach to estimate the intraclass correlation coefficients.