Case SeriesSRS-22R Minimum Clinically Important Difference and Substantial Clinical Benefit After Adult Lumbar Scoliosis Surgery
Introduction
Although the Scoliosis Research Society–22R instrument (SRS-22R) [1] was initially designed as a disease-specific instrument to measure health-related quality of life (HRQOL) in patients with adolescent idiopathic scoliosis [1], [2], [3], [4], its use has been extended to patients with adult spinal deformity. Studies have shown that it is reliable, valid, and responsive to change in patients with adult spinal deformity (ASD) [5], [6], [7]. However, patients with ASD are a heterogenous group and may present with varying degrees and types of curvatures.
Most spine surgeons consider patients with lumbar degenerative scoliosis (LDS) as a unique subgroup as these patients include those with asymmetric disc collapse, facet arthritis, and stenosis. Surgical planning for LDS patients usually involves decompression with or without fusion that does not extend into the thoracic spine and may not require complex maneuvers to correct the deformity.
The minimum clinically important difference (MCID) [8], [9] and substantial clinical benefit (SCB) [10] thresholds for the SRS22R domains in patients with ASD who underwent surgical fusion extending into the thoracic spine have been reported [11], [12]. It is unknown if the same thresholds hold true for patients with primarily degenerative lumbar scoliosis. The purpose of the current study is to determine if these thresholds reported for adult spinal deformity applies to patients with LDS.
Section snippets
Methods
Deidentified data from subjects enrolled in a National Institutes of Health–sponsored trial for adult symptomatic lumbar scoliosis who underwent surgery and completed the SRS22R preoperatively and the SRS30 one year postoperatively were identified. One-year postoperative answers to the last 8 questions of the SRS-30 (Table 1) were used as anchors for the Appearance (Items 23, 24, 28, 29, and 30), Activity (Items 25 and 26), and Pain (Item 27) domains as well as the Total score (Items 23 to 30).
Results
The sample population consisted of 147 patients. Among them, 132 (89%) were females, with a mean age of 59.4 ± 8.8 years. There was a statistically significant improvement in all SRS22R scores from preoperative to one year postoperation (Table 2). Mean preoperative SRS22R Appearance score was 2.70, improving to 3.95 at one year postoperation. Mean preoperative SRS22R Activity score was 3.12, improving to 3.51 at one year postoperation. Mean preoperative SRS22R Pain score was 2.78, improving to
Discussion
Although clinical studies typically aggregate all ASD patients, patients with LDS differ from those with a thoracic deformity in etiology and indication for treatment. Patients with LDS are older and may present with symptoms, including low back pain, radiculopathy, and limited walking ability that is similar to those in patients with lumbar degenerative conditions such as spondylolisthesis or stenosis. However, comparison of baseline SRS22R Pain and Activity scores were similar between the two
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Author disclosures: LYC (member of the University of Louisville Institutional Review Board; research committee member of the Scoliosis Research Society; grant to institution from the National Institutes of Health; consultancy fees from the Washington University at St. Louis, AO Spine, and Norton Healthcare; Research Funding for Minimize Implants Maximize Outcomes RCT 2013—current from the Orthopedic Research and Educational Fund, paid to institution, outside the submitted work; research funding for study: Evidence-Based Algorithm for the Surgical Treatment of Lumbosacral Spondylolisthesis—current from the Scoliosis Research Society, paid to institution, outside the submitted work; annual required continuing education for institutional review board members, from the University of Louisville Institutional Review Board; travel and accommodations for Study Planning Meetings 06/2012, 02/2014, and 06/2014, from the Association for Collaborative Spine Research; travel and accommodations for Study Planning Meetings 10/2013, 05/2014, 09/2014, 12/2014, 05/2015, 08/2015, 04/2016, and 08/2016/12/2016 from the Center for Spine Surgery and Research, Region of Southern Denmark; and other from NuVasive [Nuvasive provides funds directly to database company; no funds are paid directly to Individual or Individual's Institution 06/2012-04/2015]); MPK (grant to institution from the National Institutes of Health; grants to institution from AO Spine, Barnes Jewish Foundation, Orthopedic Research Education Foundation, and Cervical Spine Research Society, all outside the submitted work; fellowship support from AO Spine and Orthopedic Research Education Foundation, both outside the submitted work); CHC (grant to institution from the National Institutes of Health; consultancy fees from Alphatec, Medtronic, Norton Healthcare, and University of Louisville; grants to institution from the National Institutes of Health, Orthopedic Research Education Foundation, and Norton Healthcare; payment for lectures including service on speakers bureaus from DePuy Synthes; travel support from North American Spine Society and Scoliosis Research Society committee meetings; and other); CRB (grant to institution from the National Institutes of Health); SDG (grant to institution from the National Institutes of Health; employee of Norton Healthcare; patents issued for Medtronic; royalties from Medtronic; and other from NuVasive [NuVasive provides funds directly to database company; no funds are paid directly to Individual or Individual's Institution 06/2012-04/2015]); CIS (grant to institution from the National Institutes of Health; consultancy fees from Stryker and K2M; grants to institution from the Department of Defense and the International Spine Study Group; royalties from Biomet, Medtronic, and NuVasive; stocks/stock options in NuVasive; and fellowship support from AOSpine and NREF); KHB (grant to institution from the National Institutes of Health and royalties from Wolters-Kluwer).