title: Patient-reported outcomes 3 months after spine surgery: is it an accurate predictor of 12-month outcome in real-world registry platforms?
abstract: OBJECT The health care landscape is rapidly shifting to incentivize quality of care rather than quantity of care. Quality and outcomes registry platforms lie at the center of all emerging evidence-driven reform models and will be used to inform decision makers in health care delivery. Obtaining real-world registry outcomes data from patients 12 months after spine surgery remains a challenge. The authors set out to determine whether 3-month patient-reported outcomes accurately predict 12-month outcomes and, hence, whether 3-month measurement systems suffice to identify effective versus noneffective spine care. METHODS All patients undergoing lumbar spine surgery for degenerative disease at a single medical institution over a 2-year period were enrolled in a prospective longitudinal registry. Patient-reported outcome instruments (numeric rating scale [NRS], Oswestry Disability Index [ODI], 12-Item Short Form Health Survey [SF-12], EQ-5D, and the Zung Self-Rating Depression Scale) were recorded prospectively at baseline and at 3 months and 12 months after surgery. Linear regression was performed to determine the independent association of 3- and 12-month outcome. Receiver operating characteristic (ROC) curve analysis was performed to determine whether improvement in general health state (EQ-5D) and disability (ODI) at 3 months accurately predicted improvement and achievement of minimum clinical important difference (MCID) at 12 months. RESULTS A total of 593 patients undergoing elective lumbar surgery were included in the study. There was a significant correlation between 3-month and 12-month EQ-5D (r = 0.71; p < 0.0001) and ODI (r = 0.70; p < 0.0001); however, the authors observed a sizable discrepancy in achievement of a clinically significant improvement (MCID) threshold at 3 versus 12 months on an individual patient level. For postoperative disability (ODI), 11.5% of patients who achieved an MCID threshold at 3 months dropped below this threshold at 12 months; 10.5% of patients who did not meet the MCID threshold at 3 months continued to improve and ultimately surpassed the MCID threshold at 12 months. For ODI, achieving MCID at 3 months accurately predicted 12-month MCID with only 62.6% specificity and 86.8% sensitivity. For postoperative health utility (EQ-5D), 8.5% of patients lost an MCID threshold improvement from 3 months to 12 months, while 4.0% gained the MCID threshold between 3 and 12 months postoperatively. For EQ-5D (quality-adjusted life years), achieving MCID at 3 months accurately predicted 12-month MCID with only 87.7% specificity and 87.2% sensitivity. CONCLUSIONS In a prospective registry, patient-reported measures of treatment effectiveness obtained at 3 months correlated with 12-month measures overall in aggregate, but did not reliably predict 12-month outcome at the patient level. Many patients who do not benefit from surgery by 3 months do so by 12 months, and, conversely, many patients reporting meaningful improvement by 3 months report loss of benefit at 12 months. Prospective longitudinal spine outcomes registries need to span at least 12 months to identify effective versus noneffective patient care.
authors.affiliation: Departments of 1 Neurological Surgery and.
authors.forename: Scott L
authors.initials: SL
authors.lastname: Parker
authors.affiliation: Carolina Neurosurgery & Spine Associates, Charlotte, North Carolina.
authors.forename: Anthony L
authors.initials: AL
authors.lastname: Asher
authors.affiliation: Departments of 1 Neurological Surgery and.
authors.forename: Saniya S
authors.initials: SS
authors.lastname: Godil
authors.affiliation: Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee; and.
authors.forename: Clinton J
authors.initials: CJ
authors.lastname: Devin
authors.affiliation: Carolina Neurosurgery & Spine Associates, Charlotte, North Carolina.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: McGirt
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D063868:Patient Outcome Assessment; D017060:Patient Satisfaction; D011183:Postoperative Complications / Q000209:etiology*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D019057:Quality-Adjusted Life Years; D012042:Registries; D013119:Spinal Cord Injuries / Q000601:surgery*; D013131:Spine / Q000601:surgery*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
keywords: ASA = American Society of Anesthesiologists; MCID = minimum clinical important difference; ODI = Oswestry Disability Index; PRO = patient-reported outcome; ROC = receiver operating characteristic; SF-12 = 12-Item Short Form Health Survey; VSR = Vanderbilt Spine Registry; outcomes; registry science; spine