The design and rationale of the Biomarkers for Evaluating Spine Treatments trial: a sequential multiple assignment randomized trial.
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Mauck Matthew C, Barth Kelly S, Bell Kevin M, Brooks Amber K, Chadwick Andrea L, Gunn Cameron A, Hurley Robert W, Ivanova Anastasia, Piva Sara R, Schneider Michael J, Bailey Jeannie F, Bagaason Sarah, Batorsky Anna, Borckardt Jeffrey J, Bowden Anton E, Carey Timothy S, Castellanos Joel, Chen Lucy, Chidgey Brooke, Dalton Diane, Dufour Jonathan S, Fields Aaron J, Fritz Julie M, Goolsby Rachel West, Greco Carol M, Harris Richard E, Harte Steven, Hassett Afton L, Hoffmeyer Anna, Jones Berkeley Sara, Kaplan Chelsea, Kidwell Kelley M, Knapik Gregory G, Kosorok Michael R, Kurillo Gregorij, Lobo Remy, Lotz Jeffrey C, Mackey Sean, Mageswaran Prasath, Majumdar Sharmila, Mao Jianren, Marras William S, McCumber Micah, McLean Samuel A, Mehling Wolf, Mitchell Ulrike H, Napadow Vitaly J, O'Neill Conor, Patel Kushang V, Peltier Scott, Psioda Matthew, Rowland Bryce, Rundell Sean D, Schrepf Andrew, Sperger John, Vo Nam, Wallace Mark S, Wasan Ajay D, Weaver Tristan E, Weber Kenneth A, Williams David A, Wilson Leslie, Zeidan Fadel, Zhao Beibo, Anstrom Kevin J, Clauw Daniel J, Sowa Gwendolyn A
Аннотация
DESIGN: The BEST trial was a sequential multiple assignment randomized trial (SMART) designed with the primary goal of identifying in whom different treatments show optimal response. The primary focus of the study was to use patient features, including biomarkers and phenotypic measures, to identify subsets of persons with cLBP who respond best to specific common treatments.
METHODS: Four interventions were chosen for the trial: Enhanced Self-Care, Acceptance and Commitment Therapy, Duloxetine, and Evidence-Based Exercise and Manual Therapy. Following a run-in period and baseline assessment, participants were randomized to 1 of the 4 treatments for the first 12-week intervention period. Participants were reassessed and based on their self-reported response to initial treatment, continued that initial treatment, were augmented with an additional randomly assigned treatment, or were switched to a new treatment.
CONCLUSION: This trial was designed to deliver rich phenotypic data that will both potentially aid in the discovery of phenotypic characteristics that predict treatment response and provide a greater mechanistic understanding of cLBP.
CLINICAL TRIAL REGISTRATION NUMBER: The Biomarkers for Evaluating Spine Treatments (BEST) trial is registered on ClinicalTrials.gov (Registration number: NCT05396014; https://clinicaltrials.gov/study/NCT05396014).