TY - JOUR
T1 - Patient factors that influence decision making
T2 - Randomization versus observational nonoperative versus observational operative treatment for adult symptomatic lumbar scoliosis
AU - Neuman, Brian J.
AU - Baldus, Christine
AU - Zebala, Lukas P.
AU - Kelly, Michael P.
AU - Shaffrey, Christopher
AU - Edwards, Charles
AU - Koski, Tyler
AU - Schwab, Frank
AU - Glassman, Steven
AU - Parent, Stefan
AU - Lewis, Stephen
AU - Lenke, Lawrence G.
AU - Buchowski, Jacob M.
AU - Smith, Justin S.
AU - Crawford, Charles H.
AU - Kim, Han Jo
AU - Lafage, Virginia
AU - Lurie, Jon
AU - Carreon, Leah
AU - Bridwell, Keith H.
N1 - Publisher Copyright:
© 2016 Wolters Kluwer Health, Inc. All rights reserved.
PY - 2016/3/4
Y1 - 2016/3/4
N2 - 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 OBSNS 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.
AB - 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 OBSNS 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.
KW - Adult lumbar scoliosis
KW - Nonsurgical treatment
KW - Patient-reported outcomes
KW - Randomized trial
KW - Surgical treatment
UR - http://www.scopus.com/inward/record.url?scp=84947093013&partnerID=8YFLogxK
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U2 - 10.1097/BRS.0000000000001222
DO - 10.1097/BRS.0000000000001222
M3 - Article
C2 - 26571162
AN - SCOPUS:84947093013
SN - 0362-2436
VL - 41
SP - E349-E358
JO - Spine
JF - Spine
IS - 6
ER -