Effect of Serious Adverse Events on Health-related Quality of Life Measures Following Surgery for Adult Symptomatic Lumbar Scoliosis

Justin S. Smith, Christopher I. Shaffrey, Michael P. Kelly, Elizabeth L. Yanik, Jon D. Lurie, Christine R. Baldus, Charles Edwards, Steven D. Glassman, Lawrence G. Lenke, Oheneba Boachie-Adjei, Jacob M. Buchowski, Leah Y. Carreon, Charles H. Crawford, Thomas J. Errico, Stephen J. Lewis, Tyler Koski, Stefan Parent, Han Jo Kim, Christopher P. Ames, Shay BessFrank J. Schwab, Keith H. Bridwell

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

Abstract

Study Design.Secondary analysis of prospective multicenter cohort.Objective.To assess effect of serious adverse events (SAEs) on 2- and 4-year patient-reported outcomes measures (PROMs) in patients surgically treated for adult symptomatic lumbar scoliosis (ASLS).Summary of Background Data.Operative treatment for ASLS can improve health-related quality of life, but has high rates of SAEs. How these SAEs effect health-related quality of life remain unclear.Methods.The ASLS study assessed operative versus nonoperative ASLS treatment, with randomized and observational arms. Patients were 40- to 80-years-old with ASLS, defined as lumbar coronal Cobb ≥30° and Oswestry Disability Index (ODI) ≥20 or Scoliosis Research Society-22 (SRS-22) ≤4.0 in pain, function, and/or self-image domains. SRS-22 subscore and ODI were compared between operative patients with and without a related SAE and nonoperative patients using an as-treated analysis combining randomized and observational cohorts.Results.Two hundred eighty-six patients were enrolled, and 2- and 4-year follow-up rates were 90% and 81%, respectively, although at the time of data extraction not all patients were eligible for 4-year follow-up. A total of 97 SAEs were reported among 173 operatively treated patients. The most common were implant failure/pseudarthrosis (n=25), proximal junctional kyphosis/failure (n=10), and minor motor deficit (n=8). At 2 years patients with an SAE improved less than those without an SAE based on SRS-22 (0.52 vs. 0.79, P=0.004) and ODI (-11.59 vs. -17.34, P=0.021). These differences were maintained at 4-years for both SRS-22 (0.51 vs. 0.86, P=0.001) and ODI (-10.73 vs. -16.69, P=0.012). Despite this effect, patients sustaining an operative SAE had greater PROM improvement than nonoperative patients (P<0.001).Conclusion.Patients affected by SAEs following surgery for ASLS had significantly less improvement of PROMs at 2- and 4-year follow-ups versus those without an SAE. Regardless of SAE occurrence, operatively treated patients had significantly greater improvement in PROMs than those treated nonoperatively.Level of Evidence: 2.

Original languageEnglish
Pages (from-to)1211-1219
Number of pages9
JournalSpine
Volume44
Issue number17
DOIs
StatePublished - Sep 1 2019

Keywords

  • adult
  • adverse events
  • complications
  • nonoperative
  • outcomes
  • scoliosis
  • spine deformity
  • surgery

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