Journal of neurosurgery. Spine
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Randomized Controlled Trial Multicenter Study Comparative Study
Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial.
OBJECTIVE The purpose of this study was to report the outcome of a study of 2-level cervical total disc replacement (Mobi-C) versus anterior cervical discectomy and fusion (ACDF). Although the long-term outcome of single-level disc replacement has been extensively described, there have not been previous reports of the 5-year outcome of 2-level cervical disc replacement. METHODS This study reports the 5-year results of a prospective, randomized US FDA investigational device exemption (IDE) study conducted at 24 centers in patients with 2-level, contiguous, cervical spondylosis. ⋯ However, there was significantly greater improvement in general and disease-specific outcome measures and a lower rate of reoperation in the 2-level disc replacement patients versus ACDF control patients. Clinical trial registration no. NCT00389597 ( clinicaltrials.gov ).
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Multicenter Study
Spinal Adverse Events Severity System, version 2 (SAVES-V2): inter- and intraobserver reliability assessment.
OBJECTIVE Reporting of adverse events (AEs) in spinal surgery uses inconsistent definitions and severity grading, making it difficult to compare results between studies. The Spinal Adverse Events Severity System, version 2 (SAVES-V2) aims to standardize the classification of spine surgery AEs; however, its inter- and intraobserver reliability are unknown. The objective of this study was to assess inter- and intraobserver reliability of the SAVES-V2 grading system for assessing AEs in spinal surgery. ⋯ Agreement on impact of the AE on LOS was excellent in the DSSG and fair in the STSG. CONCLUSIONS There was good agreement on the presence, severity, and number of AEs in both trauma and degenerative cases in using the SAVES-V2. This grading system is a simple, reliable tool for identifying and capturing AEs in spinal surgery.
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OBJECTIVE Beginning in 2008, the Centers for Medicare and Medicaid Service (CMS) determined that certain hospital-acquired adverse events such as surgical site infection (SSI) following spine surgery should never occur. The following year, they expanded the ruling to include deep vein thrombosis (DVT) and pulmonary embolism (PE) following total joint arthroplasty. Due to their ruling that "never events" are not the payers' responsibility, CMS insists that the costs of managing these complications be borne by hospitals and health care providers, rather than billings to health care payers for additional care required in their management. ⋯ CONCLUSIONS Although incidence rates are low, adverse events of spinal procedures substantially increase the cost of care. Charges for patients experiencing DVT, PE, and SSI increased in this study by factors ranging from 1.8 to 4.3 times those for patients without such complications across 5 common spinal and orthopedic procedures. Cost projections by health care providers will need to incorporate expected costs of added care for patients experiencing such complications, assuming that the cost burden of such events continues to shift from payers to providers.
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Multicenter Study Observational Study
Inadequacy of 3-month Oswestry Disability Index outcome for assessing individual longer-term patient experience after lumbar spine surgery.
OBJECTIVE Prospective longitudinal outcomes registries are at the center of evidence-driven health care reform. Obtaining real-world outcomes data at 12 months can be costly and challenging. In the present study, the authors analyzed whether 3-month outcome measurements sufficiently represent 12-month outcomes for patients with degenerative lumbar disease undergoing surgery. ⋯ The discordance rates of achieving or not achieving MCID for ODI were in the range of 19% to 27% for all diagnoses and treatments (decompression with and without fusion). The positive and negative predictive value of 3-months ODI to predict 12-month ODI was 86% and 60% for MCID and 82% and 67% for SCB. CONCLUSIONS Based on their findings, the authors conclude the following: 1) Predictive methods for functional outcome based on early patient experience (i.e., baseline and/or 3-month data) should be used to help evaluate the effectiveness of procedures in patient populations, rather than serving as a proxy for long-term individual patient experience. 2) Prospective longitudinal registries need to span at least 12 months to determine the effectiveness of spine care at the individual patient and practitioner level.
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OBJECTIVE The accuracy of public reporting in health care is an issue of debate. The authors investigated the association of patient satisfaction measures from a public reporting platform with objective outcomes for patients undergoing spine surgery. METHODS The authors performed a cohort study involving patients undergoing elective spine surgery from 2009 to 2013 who were registered in the New York Statewide Planning and Research Cooperative System database. ⋯ Similar associations were identified for hospitals with a higher percentage of patients who claimed they would recommend these institutions to others. CONCLUSIONS Merging a comprehensive all-payer cohort of spine surgery patients in New York state with data from the CMS Hospital Compare website, the authors were not able to demonstrate an association of improved performance in patient satisfaction measures with decreased mortality, rate of discharge to rehabilitation, and hospitalization charges. Increased patient satisfaction was associated with decreased LOS.