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Patient Factors That Influence Decision Making

Randomization Versus Observational Nonoperative Versus Observational Operative Treatment for Adult Symptomatic Lumbar Scoliosis

Neuman, Brian J. MD; Baldus, Christine RN, MHS; Zebala, Lukas P. MD; Kelly, Michael P. MD; Shaffrey, Christopher MD; Edwards, Charles II MD; Koski, Tyler MD; Schwab, Frank MD; Glassman, Steven MD; Parent, Stefan MD; Lewis, Stephen MD; Lenke, Lawrence G. MD; Buchowski, Jacob M. MD; Smith, Justin S. MD, PhD; Crawford, Charles H. III MD; Kim, Han Jo MD; Lafage, Virginia PhD; Lurie, Jon MD; Carreon, Leah MD; Bridwell, Keith H. MD

doi: 10.1097/BRS.0000000000001222
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Study Design. A prospective study with randomized and observational cohorts.

Objective. The aim of this study was to determine baseline variables affecting adult symptomatic lumbar scoliosis (ASLS) decision making to participate in randomization (RAND), observational nonsurgical (OBS-NS), or observational surgical (OBS-S) cohorts.

Summary of Background Data. Multiple factors play a key role in a patient's decision to be randomized or to choose an OBS-NS or OBS-S course for ASLS. Studies evaluating these factors are limited.

Methods. Eligible candidates (patients with ASLS and no prior spinal fusion deformity surgery) from 9 centers participated in a RAND, OBS-NS, or OBS-S cohort study. Baseline variables (demographics, socioeconomics, patient-reported outcomes [PROs], Functional Treadmill Test, radiographs) were analyzed.

Results. Two hundred ninety-five patients were enrolled: 67 RAND, 115 OBS-NS, 113 OBS-S. Subanalysis of older patients (60–80 years) found 54% of OBS-NS had college degrees compared with 82% of RAND and 71% of OBS-S (P = 0.010). Patients deciding to be part of a RAND cohort have similar clinical characteristics to the OBS-S cohort. OBS-S had more symptomatic spinal stenosis (57% vs. 39%, P = 0.029) and worse scores than OBS-NS on the basis of PROs (Back Pain Numerical Rating Scale [NRS 6.3 vs. 5.5, P = 0.007]; Scoliosis Research Society [SRS] Pain [2.8 vs. 3.0, P = 0.018], Function [3.1 vs. 3.4, P = 0.019] and Self-Image [2.7 vs. 3.1, P = 0.002]; Oswestry Disability Index (ODI) [36.9 vs. 31.8, P = 0.029]; post-Treadmill back [5.8 vs. 4.4, P = 0.002] and leg [4.3 vs. 3.1, P = 0.037] pain NRS and larger lumbar coronal Cobb angles (56.5 degrees vs. 48.8 degrees, P < 0.001). RAND had more baseline motor deficits (10.4% vs. 1.7%, P = 0.036) and worse scores than OBS-NS on the basis of ODI (38.8 vs. 31.8, P = 0.006), SRS Function [3.1 vs. 3.4, P = 0.034], and Self-Image [2.7 vs. 3.1, P = 0.007].

Conclusion. Patients with worse PROs, more back pain, more back and leg pain with ambulation, and larger lumbar Cobb angles are more inclined to select surgical over nonsurgical management.

Level of Evidence: 1

*John Hopkins University, Baltimore, MD

Washington University, St. Louis, MO

University of Virginia, Charlottesville, VA

§Mercy Medical Center, Baltimore, MD

Northwestern University, Chicago, IL

||NYU Langone Medical Center, NYC, NY

**Hospital for Special Surgery, NYC, NY

††Norton Leatherman Spine Center, Louisville, KY

‡‡Sainte-Justine University Hospital, Montreal, QC

§§UHN Orthopaedics-Toronto Western Hospital, Toronto, ON

¶¶Dartmouth College, Hanover, NH.

Address correspondence and reprint requests to Keith H. Bridwell, MD, Washington University in St. Louis School of Medicine, Department of Orthopedic Surgery, 660 South Euclid Avenue, Campus Box 8233, St. Louis, MO 63110; E-mail: bridwellk@wudosis.wustl.edu

Received 12 May, 2015

Revised 2 September, 2015

Accepted 7 September, 2015

The manuscript submitted does not contain information about medical device(s)/drug(s).

National Institutes of Health (NIH) grant funds were received in support of this work.

Relevant financial activities outside the submitted work: board membership, consultancy, employment, grants, patents, expert testimony, payment for lectures, royalties, stocks, travel/accommodations/meeting expenses.

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