Effect modifiers for patient-reported outcomes in operatively and nonoperatively treated patients with adult symptomatic lumbar scoliosis: a combined analysis of randomized and observational cohorts.

Abstract

OBJECTIVE:Adult symptomatic lumbar scoliosis (ASLS) is a common and disabling condition. The ASLS-1 was a multicenter, dual-arm study (with randomized and observational cohorts) examining operative and nonoperative care on health-related quality of life in ASLS. An aim of ASLS-1 was to determine patient and radiographic factors that modify the effect of operative treatment for ASLS. METHODS:Patients 40-80 years old with ASLS were enrolled in randomized and observational cohorts at 9 North American centers. Primary outcomes were the differences in mean change from baseline to 2-year follow-up for the SRS-22 subscore (SRS-SS) and the Oswestry Disability Index (ODI). Analyses were performed using an as-treated approach with combined cohorts. Factors examined were prespecified or determined using regression tree analysis. For each potential effect modifier, subgroups were created using clinically relevant cutoffs or via regression trees. Estimates of within-group and between-group change were compared using generalized linear mixed models. An effect modifier was defined as a treatment effect difference greater than the minimal detectable measurement difference for both SRS-SS (0.4) and ODI (7). RESULTS:Two hundred eighty-six patients were enrolled and 256 (90%) completed 2-year follow-up; 171 received operative treatment and 115 received nonoperative treatment. Surgery was superior to nonoperative care for all effect subgroups considered, with the exception of those with nearly normal pelvic incidence-lumbar lordosis (PI-LL) match (≤ 11°). Male patients and patients with more (> 11°) PI-LL mismatch at baseline had greater operative treatment effects on both the SRS-SS and ODI compared to nonoperative treatment. No other radiographic subgroups were associated with treatment effects. High BMI, lower socioeconomic status, and poor mental health were not related to worse outcomes. CONCLUSIONS:Numerous factors previously related to poor outcomes with surgery, such as low mental health, lower socioeconomic status, and high BMI, were not related to outcomes in ASLS in this exploratory analysis. Those patients with higher PI-LL mismatch did improve more with surgery than those with normal alignment. On average, none of the factors considered were associated with a worse outcome with operative treatment versus nonoperative treatment. These findings may guide future prospective analyses of factors related to outcomes in ASLS care.

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Journal article

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Subjects

ASLS = adult symptomatic lumbar scoliosis, BMD = bone mineral density, GLMM = generalized linear mixed model, HRQOL = health-related quality of life, LL = lumbar lordosis, MCID = minimum clinically important difference, MCS = mental component summary, MDMD = minimum detectable measurement difference, NRS = numeric rating scale, ODI = Oswestry Disability Index, PCS = physical component summary, PI = pelvic incidence, PRO = patient-reported outcome, SRS-SS = SRS-22 subscore, adult lumbar scoliosis, deformity, effect modifier, patient-reported outcomes

Citation

Published Version (Please cite this version)

10.3171/2020.1.spine191288

Publication Info

Yanik, Elizabeth L, Michael P Kelly, Jon D Lurie, Christine R Baldus, Christopher I Shaffrey, Frank J Schwab, Shay Bess, Lawrence G Lenke, et al. (2020). Effect modifiers for patient-reported outcomes in operatively and nonoperatively treated patients with adult symptomatic lumbar scoliosis: a combined analysis of randomized and observational cohorts. Journal of neurosurgery. Spine, 33(1). pp. 1–10. 10.3171/2020.1.spine191288 Retrieved from https://hdl.handle.net/10161/28158.

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Scholars@Duke

Shaffrey

Christopher Ignatius Shaffrey

Professor of Orthopaedic Surgery

I have more than 25 years of experience treating patients of all ages with spinal disorders. I have had an interest in the management of spinal disorders since starting my medical education. I performed residencies in both orthopaedic surgery and neurosurgery to gain a comprehensive understanding of the entire range of spinal disorders. My goal has been to find innovative ways to manage the range of spinal conditions, straightforward to complex. I have a focus on managing patients with complex spinal disorders. My patient evaluation and management philosophy is to provide engaged, compassionate care that focuses on providing the simplest and least aggressive treatment option for a particular condition. In many cases, non-operative treatment options exist to improve a patient’s symptoms. I have been actively engaged in clinical research to find the best ways to manage spinal disorders in order to achieve better results with fewer complications.


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