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.

Yanik, Elizabeth L

Kelly, Michael P

Lurie, Jon D

Baldus, Christine R

Shaffrey, Christopher I

Schwab, Frank J

Bess, Shay

Lenke, Lawrence G

LaBore, Adam

Bridwell, Keith H

2023-06-20T12:01:47Z

2023-06-20T12:01:47Z

2020-03

2023-06-20T12:01:42Z

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.

2020.1.SPINE191288

1547-5654

1547-5646

https://hdl.handle.net/10161/28158

eng

Journal of Neurosurgery Publishing Group (JNSPG)

Journal of neurosurgery. Spine

10.3171/2020.1.spine191288

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

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 article

Shaffrey, Christopher I|0000-0001-9760-8386

1

10

1

Duke

School of Medicine

Clinical Science Departments

Orthopaedic Surgery

Neurosurgery

Published

33