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.
RCT Entities:
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.
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