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Anthony L. Asher, Matthew J. McGirt and Zoher Ghogawala

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Matthew J. McGirt, Ahilan Sivaganesan, Anthony L. Asher and Clinton J. Devin

OBJECT

Lumbar spine surgery has been demonstrated to be efficacious for many degenerative spine conditions. However, there is wide variability in outcome after spine surgery at the individual patient level. All stakeholders in spine care will benefit from identification of the unique patient or disease subgroups that are least likely to benefit from surgery, are prone to costly complications, and have increased health care utilization. There remains a large demand for individual patient-level predictive analytics to guide decision support to optimize outcomes at the patient and population levels.

METHODS

One thousand eight hundred three consecutive patients undergoing spine surgery for various degenerative lumbar diagnoses were prospectively enrolled and followed for 1 year. A comprehensive patient interview and health assessment was performed at baseline and at 3 and 12 months after surgery. All predictive covariates were selected a priori. Eighty percent of the sample was randomly selected for model development, and 20% for model validation. Linear regression was performed with Bayesian model averaging to model 12-month ODI (Oswestry Disability Index). Logistic regression with Bayesian model averaging was used to model likelihood of complications, 30-day readmission, need for inpatient rehabilitation, and return to work. Goodness-of-fit was assessed via R2 for 12-month ODI and via the c-statistic, area under the receiver operating characteristic curve (AUC), for the categorical endpoints. Discrimination (predictive performance) was assessed, using R2 for the ODI model and the c-statistic for the categorical endpoint models. Calibration was assessed using a plot of predicted versus observed values for the ODI model and the Hosmer-Lemeshow test for the categorical endpoint models.

RESULTS

On average, all patient-reported outcomes (PROs) were improved after surgery (ODI baseline vs 12 month: 50.4 vs 29.5%, p < 0.001). Complications occurred in 121 patients (6.6%), 108 (5.9%) were readmitted within 30 days of surgery, 188 (10.3%) required discharge to inpatient rehabilitation, 1630 (88.9%) returned to work, and 449 (24.5%) experienced an unplanned outcome (no improvement in ODI, a complication, or readmission). There were 45 unique baseline variable inputs, derived from 39 clinical variables and 38 questionnaire items (ODI, SF-12, MSPQ, VAS-BP, VAS-LP, VAS-NP), included in each model. For prediction of 12-month ODI, R2 was 0.51 for development and 0.47 for the validation study. For prediction of a complication, readmission, inpatient rehabilitation, and return to work, AUC values ranged 0.72-0.84 for development and 0.79-0.84 for validation study.

CONCLUSIONS

A novel prediction model utilizing both clinical data and patient interview inputs explained the majority of variation in outcome observed after lumbar spine surgery and reliably predicted 12-month improvement in physical disability, return to work, major complications, readmission, and need for inpatient rehabilitation for individual patients. Application of these models may allow clinicians to offer spine surgery specifically to those who are most likely to benefit and least likely to incur complications and excess costs.

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John R. W. Kestle

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John R. W. Kestle

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Matthew J. McGirt, Theodore Speroff, Robert S. Dittus, Frank E. Harrell Jr. and Anthony L. Asher

Given the unsustainable costs of US health care, universal agreement exists among payers, regulatory agencies, and other health care stakeholders that reform must include substantial improvements in the quality, effectiveness, and value of health care delivery. The Institute of Medicine and the American Recovery and Reinvestment Act of 2009 have called for the establishment of prospective registries to capture patient-centered data from real-world practice as a high priority to guide evidence-based reform. As a result, the American Association of Neurological Surgeons launched the National Neurosurgery Quality and Outcomes Database (N2QOD) and began enrolling patients in March 2012 into its initial pilot project: a web-based lumbar spine module. As a nationwide, prospective longitudinal registry utilizing patient reported outcome instruments, the N2QOD lumbar spine surgery pilot aims to systematically measure and aggregate surgical safety and 1-year postoperative outcome data from approximately 30 neurosurgical practices across the US with the primary aim of demonstrating the feasibility and validity of standardized 1-year outcome measurement from everyday real-world practice. At the end of the pilot year, 1) risk-adjusted modeling will be developed for the safety, quality, and effectiveness of lumbar surgical care (morbidity, readmission, improvements in pain, disability, quality of life, and return to work); 2) data integrity and validation will be demonstrated via internal quality control analyses and auditing, and 3) the feasibility of obtaining a high level of follow-up (~80%) of nationwide 1-year outcome measurement will be established. N2QOD will use only prospective clinical data, will avoid the use of administrative data proxies, and will rely on neurosurgically relevant risk factors for risk adjustment. Once national benchmarks of quality and effectiveness are accurately established and validated utilizing practice-based data extractors in the pilot year, N2QOD aims to introduce non–full-time employee (FTE)–dependent methodologies such as electronic medical record auto-extraction. N2QOD's non–FTE-dependent methodologies can then be validated against practice-based data extractor–derived measures of safety and effectiveness with the aim of more rapid expansion into the majority of US practice groups. The general overview, methods, and registry design of the N2QOD pilot year (lumbar module) are presented here.

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Matthew J. McGirt, Saniya S. Godil, Anthony L. Asher, Scott L. Parker and Clinton J. Devin

OBJECT

In an era of escalating health care cost and universal pressure of improving efficiency and cost of care, ambulatory surgery centers (ASCs) have emerged as lower cost options for many surgical therapies. Anterior cervical discectomy and fusion (ACDF) is one of the most prevalent spine surgeries performed and is rapidly increasing with an expanding aging population. While ASCs offer cost advantages for ACDF, there is a scarcity of evidence that ASCs allow for equivalent quality and thus superior health care value. Therefore, the authors analyzed a nationwide, prospective quality improvement registry (National Surgical Quality Improvement Program [NSQIP]) to compare the quality of ACDF surgery performed in the outpatient ASC versus the inpatient hospital setting.

METHODS

Patients undergoing ACDF (2005-2011) were identified from the NSQIP database based on the primary Current Procedural Terminology codes. Patients were divided into 2 cohorts (outpatient vs inpatient) based on the acute care setting documented in the NSQIP database. All 30-day surgical morbidity and mortality rates were compared between the 2 groups. Propensity score matching and multivariate logistic regression analysis were used to adjust for confounding factors and to identify the independent association of outpatient ACDF with perioperative outcomes and morbidity.

RESULTS

A total of 7288 ACDF cases were identified (inpatient = 6120, outpatient = 1168). Unadjusted rates of major morbidity (0.94% vs 4.5%, p < 0.001) and return to the operating room (OR) within 30 days (0.3% vs 2.0%, p < 0.001) were significantly lower in outpatient versus inpatient ACDF. After propensity matching 1442 cases (inpatient = 650, outpatient = 792) based on baseline 32 covariates, rates of major morbidity (1.4% vs 3.1%, p = 0.03), and return to the OR (0.34% vs 1.4%, p = 0.04) remained significantly lower after outpatient ACDF. Adjusted comparison using multivariate logistic regression demonstrated that ACDF performed in the outpatient setting had 58% lower odds of having a major morbidity and 80% lower odds of return to the OR within 30 days.

CONCLUSIONS

An analysis of a nationwide, prospective quality improvement registry representing more than 250 hospitals demonstrates that 1- to 2-level ACDF can be safely performed in the outpatient ambulatory surgery setting in patients who are appropriate candidates. In an effort to decrease cost of care, surgeons can safely consider performing ACDF in an ASC environment.

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Christopher I. Shaffrey and Justin S. Smith

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Laxmaiah Manchikanti, Kenneth D. Candido, Ramsin M. Benyamin and Joshua A. Hirsch

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Scott L. Parker, Anthony L. Asher, Saniya S. Godil, Clinton J. Devin and Matthew J. McGirt

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.

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Natalie C. Edwards, Luella Engelhart, Eva M. H. Casamento and Matthew J. McGirt

OBJECT

Despite multiple preventive strategies for reducing infection, up to 15% of patients with shunt catheters and 27% of patients with external ventricular drains (EVDs) may develop an infection. There are few data on the cost-effectiveness of measures to prevent hydrocephalus catheter infection from the hospital perspective. The objective of this study was to perform a cost-consequence analysis to assess the potential clinical and economic value of antibiotic-impregnated catheter (AIC) shunts and EVDs compared with non-AIC shunts and EVDs in the treatment of hydrocephalus from a hospital perspective.

METHODS

The authors used decision analytical techniques to assess the clinical and economic consequences of using antibiotic-impregnated shunts and EVDs from a hospital perspective. Model inputs were derived from the published, peer-reviewed literature. Clinical studies comparing infection rates and the clinical and economic impact of infections associated with the use of AICs and standard catheters (non-AICs) were evaluated. Outcomes assessed included infections, deaths due to infection, surgeries due to infection, and cost associated with shunt- and EVD-related infection. A subanalysis using only AIC shunt and EVD Level I evidence (randomized controlled trial results) was conducted as an alternate to the cumulative analysis of all of the AIC versus non-AIC studies (13 of the 14 shunt studies and 4 of the 6 EVD studies identified were observational). Sensitivity analyses were conducted to determine how changes in the values of uncertain parameters affected the results of the model.

RESULTS

In 100 patients requiring shunts, AICs may be associated with 0.5 fewer deaths, 71 fewer hospital days, 11 fewer surgeries, and $128,228 of net savings in hospital costs due to decreased infection. Results of the subanalysis showed that AICs may be associated with 1.9 fewer deaths, 1611 fewer hospital days, 25 fewer surgeries, and $346,616 of net savings in hospital costs due to decreased infection. The rate of decrease in infection with AIC shunts was shown to have the greatest impact on the cost savings realized with use of AIC shunts.

In 100 patients requiring EVDs, AICs may be associated with 2.7 fewer deaths and 82 fewer hospital days due to infection. The relative risk of more severe neurological impairment was estimated to be 5.33 times greater with EVD infection. Decreases in infection with AIC EVDs resulted in an estimated $264,069 of net savings per 100 patients treated with AICs. Results of the subanalysis showed that AIC EVDs may be associated with 1.0 fewer deaths, 31 infection-related hospital days averted, and $74,631 saved per 100 patients treated with AIC EVDs. As was seen with AIC shunts, the rate of decrease in infection with AIC EVDs was shown to have the greatest impact on the cost savings realized with use of AIC EVDs.

CONCLUSIONS

The current value analysis demonstrates that evidence supports the use of AICs as effective and potentially cost-saving treatment.