The design and rationale of the Biomarkers for Evaluating Spine Treatments trial: a sequential multiple assignment randomized trial - Scorecard - MDSpire

The design and rationale of the Biomarkers for Evaluating Spine Treatments trial: a sequential multiple assignment randomized trial

  • By

  • Matthew C Mauck

  • Kelly S Barth

  • Kevin M Bell

  • Amber K Brooks

  • Andrea L Chadwick

  • Cameron A Gunn

  • Robert W Hurley

  • Anastasia Ivanova

  • Sara R Piva

  • Michael J Schneider

  • Jeannie F Bailey

  • Sarah Bagaason

  • Anna Batorsky

  • Jeffrey J Borckardt

  • Anton E Bowden

  • Timothy S Carey

  • Joel Castellanos

  • Lucy Chen

  • Brooke Chidgey

  • Diane Dalton

  • Jonathan S Dufour

  • Aaron J Fields

  • Julie M Fritz

  • Rachel West Goolsby

  • Carol M Greco

  • Richard E Harris

  • Steven Harte

  • Afton L Hassett

  • Anna Hoffmeyer

  • Sara Jones Berkeley

  • Chelsea Kaplan

  • Kelley M Kidwell

  • Gregory G Knapik

  • Michael R Kosorok

  • Gregorij Kurillo

  • Remy Lobo

  • Jeffrey C Lotz

  • Sean Mackey

  • Prasath Mageswaran

  • Sharmila Majumdar

  • Jianren Mao

  • William S Marras

  • Micah McCumber

  • Samuel A McLean

  • Wolf Mehling

  • Ulrike H Mitchell

  • Vitaly J Napadow

  • Conor O'Neill

  • Kushang V Patel

  • Scott Peltier

  • Matthew Psioda

  • Bryce Rowland

  • Sean D Rundell

  • Andrew Schrepf

  • John Sperger

  • Nam Vo

  • Mark S Wallace

  • Ajay D Wasan

  • Tristan E Weaver

  • Kenneth A Weber

  • David A Williams

  • Leslie Wilson

  • Fadel Zeidan

  • Beibo Zhao

  • Kevin J Anstrom

  • Daniel J Clauw

  • Gwendolyn A Sowa

  • April 9, 2025

  • 0 min

Share

Clinical Scorecard: Overview and Justification of the Biomarkers for Assessing Spine Interventions Study: A Sequential Multiple Assignment Randomized Trial

At a Glance

CategoryDetail
ConditionChronic low back pain (cLBP)
Key MechanismsUse of patient features including biomarkers and phenotypic measures to identify subsets of persons with cLBP who respond best to specific treatments
Target PopulationAdults aged 20-69 with chronic low back pain
Care SettingOutpatient clinical settings involving non-surgical interventions

Key Highlights

  • cLBP affects approximately 13.1% of adults aged 20-69 in the US and is the leading cause of disability.
  • The BEST trial uses a sequential multiple assignment randomized trial (SMART) design to personalize treatment based on patient phenotypes and biomarkers.
  • Four evidence-based non-opioid treatments studied: Enhanced Self-Care, Acceptance and Commitment Therapy, Duloxetine, and Evidence-Based Exercise and Manual Therapy.

Guideline-Based Recommendations

Diagnosis

  • Assess chronic low back pain using phenotypic characteristics and biomarkers to guide treatment selection.

Management

  • Employ non-opioid treatments as first-line interventions for cLBP.
  • Use a sequential treatment approach adapting based on patient response after initial 12-week intervention.
  • Consider combining or switching treatments based on self-reported treatment response.

Monitoring & Follow-up

  • Regularly reassess patient response to initial and subsequent treatments to guide therapy adjustments.

Risks

  • Opioid use in cLBP patients carries risk of opioid use disorder; non-opioid treatments are preferred to mitigate this risk.

Patient & Prescribing Data

Adults with chronic low back pain enrolled in the BEST trial.

Treatment response varies widely; identifying phenotypic and biomarker predictors may optimize individual treatment selection and improve outcomes.

Clinical Best Practices

  • Utilize a precision medicine approach incorporating biomarkers and phenotypic data to tailor cLBP treatment.
  • Implement evidence-based non-opioid therapies as initial treatment options.
  • Adapt treatment plans sequentially based on patient-reported outcomes to maximize effectiveness.
  • Avoid opioid prescribing when possible due to associated risks.

References

Original Source(s)

The design and rationale of the Biomarkers for Evaluating Spine Treatments trial: a sequential multiple assignment randomized trial

  • by Matthew C Mauck, Kelly S Barth, Kevin M Bell, Amber K Brooks, Andrea L Chadwick, Cameron A Gunn, Robert W Hurley, Anastasia Ivanova, Sara R Piva, Michael J Schneider, Jeannie F Bailey, Sarah Bagaason, Anna Batorsky, Jeffrey J Borckardt, Anton E Bowden, Timothy S Carey, Joel Castellanos, Lucy Chen, Brooke Chidgey, Diane Dalton, Jonathan S Dufour, Aaron J Fields, Julie M Fritz, Rachel West Goolsby, Carol M Greco, Richard E Harris, Steven Harte, Afton L Hassett, Anna Hoffmeyer, Sara Jones Berkeley, Chelsea Kaplan, Kelley M Kidwell, Gregory G Knapik, Michael R Kosorok, Gregorij Kurillo, Remy Lobo, Jeffrey C Lotz, Sean Mackey, Prasath Mageswaran, Sharmila Majumdar, Jianren Mao, William S Marras, Micah McCumber, Samuel A McLean, Wolf Mehling, Ulrike H Mitchell, Vitaly J Napadow, Conor O'Neill, Kushang V Patel, Scott Peltier, Matthew Psioda, Bryce Rowland, Sean D Rundell, Andrew Schrepf, John Sperger, Nam Vo, Mark S Wallace, Ajay D Wasan, Tristan E Weaver, Kenneth A Weber, David A Williams, Leslie Wilson, Fadel Zeidan, Beibo Zhao, Kevin J Anstrom, Daniel J Clauw, Gwendolyn A Sowa

  • April 9, 2025

Related Content

Incisional hernia and the risk of incident depression: a population-based propensity score–matched cohort study

Impulsivity and Cognitive Biases Related to Pain in Veterans Undergoing Treatment for Chronic Non-Malignant Pain

Side Effects: Salt, Steroids, and Second Brains

So get this: sodium may track with memory decline (in men), steroids might not be “immunosuppressive” in the ICU, and second pregnancies reshape the brain differently than first. Same theme: biology is less binary than we teach it.