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Daniel M. Sciubba, Li-Mei Lin, Graeme F. Woodworth, Matthew J. McGirt, Benjamin Carson, and George I. Jallo

Object

Antibiotic-impregnated shunt (AIS) systems may decrease the incidence of cerebrospinal fluid (CSF) shunt infections. However, there is a reluctance to use AIS components because of their increased cost. In the present study the authors evaluated factors contributing to the medical costs associated with the treatment of CSF shunt infections in a hydrocephalic pediatric population, those implanted with AIS systems compared with those implanted with standard shunt systems.

Methods

The authors retrospectively reviewed data obtained in all pediatric patients who had undergone CSF shunt insertion at their institution over a 3-year period. All patients were followed up for 12 months after surgery. The independent association between AIS catheter use and subsequent shunt infection was assessed by performing a multivariate proportional hazards regression analysis. Factors contributing to the medical costs associated with shunt infection were evaluated.

Results

Two hundred eleven pediatric patients underwent 353 shunting procedures. Two hundred eight shunts (59%) were placed with nonimpregnated catheters and 145 shunts (41%) were placed with AIS catheters. Twenty-five patients (12%) with non-AIS catheters experienced shunt infection, whereas only two patients (1.4%) with AIS catheters had a shunt infection within the 6-month follow-up period (p < 0.01). Among infected patients, infected patients with standard shunt components had a longer average hospital stay, more inpatient complications related to infection treatment, and more multiple organism infections and multiple antibiotic regimens, compared with those with AIS components.

Conclusions

Although individual AIS components are more expensive than standard ones, factors contributing to medical costs are fewer in pediatric patients with infected shunts when the components are antibiotic-impregnated rather than standard.

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Nathan R. Selden, Zoher Ghogawala, Robert E. Harbaugh, Zachary N. Litvack, Matthew J. McGirt, and Anthony L. Asher

Outcomes-directed approaches to quality improvement have been adopted by diverse industries and are increasingly the focus of government-mandated reforms to health care education and delivery. The authors identify and review current reform initiatives originating from agencies regulating and funding graduate medical education and health care delivery. These reforms use outcomes-based methodologies and incorporate principles of lifelong learning and patient centeredness.

Important new initiatives include the Accreditation Council for Graduate Medical Education Milestones; the pending adoption by the American Board of Neurological Surgery of new requirements for Maintenance of Certification that are in part outcomes based; initiation by health care systems and consortia of public reporting of patient outcomes data; institution by the Centers for Medicare & Medicaid Services of requirements for comparative effectiveness research and the physician quality reporting system; and linking of health care reimbursement in part to patient outcomes data and quality measures. Opportunities exist to coordinate and unify patient outcomes measurement throughout neurosurgical training and practice, enabling effective patient-centered improvements in care delivery as well as efficient compliance with regulatory mandates. Coordination will likely require the development of a new science of practice based in the daily clinical environment and utilizing clinical data registries. A generation of outcomes science and quality experts within neurosurgery should be trained to facilitate attainment of these goals.

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Anthony L. Asher, Paul C. McCormick, Nathan R. Selden, Zoher Ghogawala, and Matthew J. McGirt

Patient care data will soon inform all areas of health care decision making and will define clinical performance. Organized neurosurgery believes that prospective, systematic tracking of practice patterns and patient outcomes will allow neurosurgeons to improve the quality and efficiency and, ultimately, the value of care. In support of this mission, the American Association of Neurological Surgeons, in cooperation with a broad coalition of other neurosurgical societies including the Congress of Neurological Surgeons, Society of Neurological Surgeons, and American Board of Neurological Surgery, created the NeuroPoint Alliance (NPA), a not-for-profit corporation, in 2008. The NPA coordinates a variety of national projects involving the acquisition, analysis, and reporting of clinical data from neurosurgical practice using online technologies. It was designed to meet the health care quality and related research needs of individual neurosurgeons and neurosurgical practices, national organizations, health care plans, biomedical industry, and government agencies. To meet the growing need for tools to measure and promote high-quality care, NPA collaborated with several national stakeholders to create an unprecedented program: the National Neurosurgery Quality and Outcomes Database (N2QOD). This resource will allow any US neurosurgeon, practice group, or hospital system to contribute to and access aggregate quality and outcomes data through a centralized, nationally coordinated clinical registry. This paper describes the practical and scientific justifications for a national neurosurgical registry; the conceptualization, design, development, and implementation of the N2QOD; and the likely role of prospective, cooperative clinical data collection systems in evolving systems of neurosurgical training, continuing education, research, public reporting, and maintenance of certification.

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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, Theodore Speroff, Saniya Siraj Godil, Joseph S. Cheng, Nathan R. Selden, and Anthony L. Asher

In terms of policy, research, quality improvement, and practice-based learning, there are essential principles—namely, quality, effectiveness, and value of care—needed to navigate changes in the current and future US health care environment. Patient-centered outcome measurement lies at the core of all 3 principles. Multiple measures of disease-specific disability, generic health-related quality of life, and preference-based health state have been introduced to quantify disease impact and define effectiveness of care. This paper reviews the basic principles of patient outcome measurement and commonly used outcome instruments. The authors provide examples of how utilization of outcome measurement tools in everyday neurosurgical practice can facilitate practice-based learning, quality improvement, and real-world comparative effectiveness research, as well as promote the value of neurosurgical care.

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Anthony L. Asher, Matthew J. McGirt, Steven D. Glassman, Rachel Groman, Dan K. Resnick, Melissa Mehrlich, Elizabeth Spivey, and Paul McCormick

Clinical registries have emerged in the current resource-restricted environment of modern medicine as useful and logical mechanisms for providing health care stakeholders with high-quality data related to the safety, effectiveness, and value of specific interventions. Temporal and qualitative requirements for data acquisition in the context of clinical registries have rapidly expanded as clinicians and other stakeholders increasingly recognize the central importance of this information to the intelligent transformation of health care processes. Despite the potential of more robust clinical data collection efforts to advance the science of care, certain aspects of these newer systems, particularly the prospective, longitudinal acquisition of clinical data and direct patient contact, represent areas of structural overlap between emerging quality improvement efforts and traditional models of human subjects research. This overlap has profound implications for the design and implementation of modern clinical registries. In this paper, the authors describe the evolution of clinical registries as important tools for advancing the science of practice, and review the existing federal regulations that apply to these systems.

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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.

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John R. W. Kestle