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

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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.

ABBREVIATIONS 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.
Article Information

Contributor Notes

Correspondence Michael P. Kelly: Washington University School of Medicine, St. Louis, MO. kellymi@wustl.edu.INCLUDE WHEN CITING Published online March 6, 2020; DOI: 10.3171/2020.1.SPINE191288.Disclosures Dr. Shaffrey reports being a consultant to Medtronic, NuVasvive, and SI Bone; having direct stock ownership in NuVasive; and being a patent holder for Medtronic, NuVasive, and Zimmer Biomet. Dr. Schwab reports being a consultant for K2 Medical LLC, Zimmer Biomet, and Globus Medical Inc,; receiving royalties from Medtronic Sofamor Danek, Zimmer Biomet, and Medicrea USA Corp.; receiving honoraria from Zimmer Biomet; and having ownership in the International Spine Study Group. Dr. Bess reports being a consultant to Stryker and Mirus; being a patent holder for K2M; receiving clinical or research support for this study from ISSGF; and receiving support of non–study-related clinical or research effort from ISSGF. Dr. Lenke reports being a paid consultant to, and receiving royalties from, Medtronic; receiving reimbursement for travel expenses from Broadwater, the Seattle Science Foundation, the Scoliosis Research Society, Stryker Spine, The Spinal Research Foundation, and AOSpine; receiving grant support from the Scoliosis Research Society, EOS, Setting Scoliosis Straight Foundation, and AOSpine; being an expert witness for Fox Rothschild LLC; receiving royalties from Quality Medical Publishing; receiving philanthropic research funding from a grateful patient/family from the Evans Family and the Fox Family Foundation; receiving fellowship support from AOSpine; and being a paid consultant to EOS Technologies and Acuity Surgical.
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