title: Effect of complications within 90 days on patient-reported outcomes 3 months and 12 months following elective surgery for lumbar degenerative disease.
abstract: OBJECT There is a paradigm shift toward rewarding providers for quality rather than volume. Complications appear to occur at a fairly consistent frequency in large aggregate data sets. Understanding how complications affect long-term patient-reported outcomes (PROs) following degenerative lumbar surgery is vital. The authors hypothesized that 90-day complications would adversely affect long-term PROs. METHODS Nine hundred six consecutive patients undergoing elective surgery for degenerative lumbar disease over a period of 4 years were enrolled into a prospective longitudinal registry. The following PROs were recorded at baseline and 12-month follow-up: Oswestry Disability Index (ODI) score, numeric rating scales for back and leg pain, quality of life (EQ-5D scores), general physical and mental health (SF-12 Physical Component Summary [PCS] and Mental Component Summary [MCS] scores) and responses to the North American Spine Society (NASS) satisfaction questionnaire. Previously published minimum clinically important difference (MCID) threshold were used to define meaningful improvement. Complications were divided into major (surgicalsite infection, hardware failure, new neurological deficit, pulmonary embolism, hematoma and myocardial infarction) and minor (urinary tract infection, pneumonia, and deep venous thrombosis). RESULTS Complications developed within 90 days of surgery in 13% (118) of the patients (major in 12% [108] and minor in 8% [68]). The mean improvement in ODI scores, EQ-5D scores, SF-12 PCS scores, and satisfaction at 3 months after surgery was significantly less in the patients with complications than in those who did not have major complications (ODI: 13.5 ± 21.2 vs 21.7 ± 19, < 0.0001; EQ-5D: 0.17 ± 0.25 vs 0.23 ± 0.23, p = 0.04; SF-12 PCS: 8.6 ± 13.3 vs 13.0 ± 11.9, 0.001; and satisfaction: 76% vs 90%, p = 0.002). At 12 months after surgery, the patients with major complications had higher ODI scores than those without complications (29.1 ± 17.7 vs 25.3 ± 18.3, p = 0.02). However, there was no difference in the change scores in ODI and absolute scores across all other PROs between the 2 groups. In multivariable linear regression analysis, after controlling for an array of preoperative variables, the occurrence of a major complication was not associated with worsening ODI scores 12 months after surgery. There was no difference in the percentage of patients achieving the MCID for disability (66% vs 64%), back pain (55% vs 56%), leg pain (62% vs 59%), or quality of life (19% vs 14%) or in patient satisfaction rates (82% vs 80%) between those without and with major complications. CONCLUSIONS Major complications within 90 days following lumbar spine surgery have significant impact on the short-term PROs. Patients with complications, however, do eventually achieve clinically meaningful outcomes and report satisfaction equivalent to those without major complications. This information allows a physician to counsel patients on the fact that a complication creates frustration, cost, and inconvenience; however, it does not appear to adversely affect clinically meaningful long-term outcomes and satisfaction.
authors.affiliation: Departments of 1 Orthopaedic Surgery and |Neurological Surgery, Vanderbilt University Medical Center, Nashville, Tennessee; and 
authors.forename: Silky
authors.initials: S
authors.lastname: Chotai
authors.affiliation: Departments of 1 Orthopaedic Surgery and |Neurological Surgery, Vanderbilt University Medical Center, Nashville, Tennessee; and 
authors.forename: Scott L
authors.initials: SL
authors.lastname: Parker
authors.affiliation: Departments of 1 Orthopaedic Surgery and |Neurological Surgery, Vanderbilt University Medical Center, Nashville, Tennessee; and 
authors.forename: Ahilan
authors.initials: A
authors.lastname: Sivaganesan
authors.affiliation: Departments of 1 Orthopaedic Surgery and |Neurological Surgery, Vanderbilt University Medical Center, Nashville, Tennessee; and 
authors.forename: J Alex
authors.initials: JA
authors.lastname: Sielatycki
authors.affiliation: Department of Neurological Surgery, Carolina Neurosurgery & Spine Associates, Charlotte, North Carolina.
authors.forename: Anthony L
authors.initials: AL
authors.lastname: Asher
authors.affiliation: Department of Neurological Surgery, Carolina Neurosurgery & Spine Associates, Charlotte, North Carolina.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: McGirt
authors.affiliation: Departments of 1 Orthopaedic Surgery and |Neurological Surgery, Vanderbilt University Medical Center, Nashville, Tennessee; and 
authors.forename: Clinton J
authors.initials: CJ
authors.lastname: Devin
mesh_terms: D000328:Adult; D000368:Aged; D004185:Disability Evaluation; D017558:Elective Surgical Procedures / Q000009:adverse effects* / Q000379:methods; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008161:Lumbosacral Region / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D019636:Neurodegenerative Diseases / Q000601:surgery*; D010147:Pain Measurement; D063868:Patient Outcome Assessment; D017060:Patient Satisfaction; D011183:Postoperative Complications / Q000503:physiopathology*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
keywords: BMI = body mass index; BP = back pain; LP = leg pain; MCID = minimum clinically significant difference; MCS = Mental Component Summary; MI = myocardial infarction; ODI = Oswestry Disability Index; PCS = Physical Component Summary; PRO = patient-reported outcome; clinically significant; complications; lumbar; patient-reported outcomes; satisfaction; spine surgery