Patient Factors That Influence Decision Making: Randomization versus Observational Nonoperative versus Observational Operative Treatment for Adult Symptomatic Lumbar Scoliosis (ASLS).
Spine (Phila Pa 1976). 2015 Oct 15;
Authors: Neuman BJ, Baldus C, Zebala LP, Kelly MP, Shaffrey C, Edwards C, Koski T, Schwab F, Glassman S, Parent S, Lewis S, Lenke LG, Buchowski JM, Smith JS, Crawford CH, Kim HJ, Lafage V, Lurie J, Carreon L, Bridwell KH
STUDY DESIGN: Prospective randomized and observational study OBJECTIVE.: 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: 295 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 to 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-value?=?0.029) and worse scores than OBS-NS based on 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° vs 48.8°, p?<?0.001). RAND had more baseline motor deficits (10.4% vs 1.7%, p?=?0.036) and worse scores than OBS-NS based on 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.
PMID: 26571162 [PubMed – as supplied by publisher]