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Christopher M. Holland, Kevin T. Foley and Anthony L. Asher

particular, these large data repositories hold enormous opportunity for improvement. Many devices facilitate the automatic measurement and storage of data points at high frequencies. For example, whereas a patient may have had their heart rate recorded only a couple of times per year during office visits with their physician, it is now possible to capture and record this information continuously, resulting in thousands of data points in a single day. The ability to collect these incredible amounts of data has far outpaced our ability to analyze it. It is in the

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Anthony L. Asher, Paul C. McCormick and Douglas Kondziolka

providers, and by extension their patients, have served as knowledge consumers. Our society created substantial financial and societal incentives for the translation of medical knowledge into new drugs, devices, and procedures, and medical discovery and the application of novel techniques have became a top health care priority in the US. That priority spawned an unprecedented scientific and industrial enterprise that defined health care progress for the latter part of the 20th century. Progress, however, is relative. Although few doubt that traditional emphases on

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Charles H. Crawford III, Steven D. Glassman, Praveen V. Mummaneni, John J. Knightly and Anthony L. Asher

symptomatic spinal stenosis when a patient complains of substantial preoperative back pain. For example, the inclusion criteria for a recent FDA investigational device exemption study that evaluated an interspinous process device versus instrumented fusion included patients with lumbar spinal stenosis and a back pain score greater than 5 of 10. 5 , 6 , 20 The implication is that patients with substantial preoperative back pain are often recommended for a stabilization procedure or fusion in addition to decompression. In a recently published guideline update regarding the

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

device applications, automated calling services, or open patient-community web portals—is currently being discussed. Minimizing Bias and Confounding (Real-World Practice Setting, Avoiding Research Consent) The advantage of prospective registries over randomized controlled trials lies not only in their timeliness, feasibility, and cost-effectiveness with respect to patient enrollment and data collection, but in their true representativeness of real-world care. Efficacy in artificially controlled research settings may not be generalizable to community health care

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

clinicians participate in the routine collection, analysis, and application of clinical data related to the safety, quality, and value of care. Health Care Reform and the Emerging Requirement for Quality Data Over the past several decades, the biomedical community has successfully used scientific methodologies to fuel dramatic progress in the practice of medicine, to the benefit of patients and the groups that serve them, including physicians and biotechnology industry. Most of this progress has been related to the development of countless new devices and procedures

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Leah Y. Carreon, Steven D. Glassman, Zoher Ghogawala, Praveen V. Mummaneni, Matthew J. McGirt and Anthony L. Asher

.html ). This change will reduce both the relative value and the payment rate for this new single current procedural terminology code as compared with the payment rates for the 2 previous codes used to report the procedures. However, because of the additional implant cost and the additional time required to insert an interbody device, TLIF will likely cost more. The other half of the cost-effectiveness equation is measuring an intervention's effectiveness. Health gains or losses after an intervention are measured as quality-adjusted life years (QALYs), 11 , 17

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Matthew J. McGirt, Scott L. Parker, Silky Chotai, Deborah Pfortmiller, Jeffrey M. Sorenson, Kevin Foley and Anthony L. Asher

require greater postdischarge needs as they continue to recover. 8 , 20 , 22 Patients with a preoperative nonambulatory status and those who are ambulatory with an assistive device have greater needs for rehabilitation and longer recovery time than patients who are ambulatory preoperatively. 1 , 10 , 11 , 30 Preoperative ambulatory status accurately reflects the severity of disability in most patients with spinal disorders. Theoretically, patients unable to walk independently will have higher ODI scores (i.e., worse disability). Indeed, in our analysis the patients

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

type of outsourced IT platform may serve as a model for future consortia. Future Directions Today, there is little question that we need to collect patient-reported outcomes and economic data to monitor the cost-effectiveness of neurosurgical interventions. The N 2 QOD will eventually leverage electronic medical record (EMR) technologies to enable automatic data capture, which will ultimately reduce the labor costs associated with data entry. As our medical culture evolves, the completion of patient-reported outcomes instruments using wireless devices will

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

collected and includes outpatient visits (surgeons, chiropractors, other physicians, physical therapists, acupuncturists, or other health care providers), spine-related diagnostic tests (radiography, CT scanning, MRI, and electromyography), injections, devices (for example, braces, canes, walkers, and shoe inserts), emergency room visits, and rehabilitation or nursing home days. Participants are asked in detail about their use of all medications, including but not limited to nonsteroidal antiinflammatory drugs and COX-2 inhibitors, oral steroids, narcotics, muscle

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Lisa R. Rogers, Jack P. Rock, Allen K. Sills, Michael A. Vogelbaum, John H. Suh, Thomas L. Ellis, Volker W. Stieber, Anthony L. Asher, Robert W. Fraser, Judith S. Billingsley, Paul Lewis, Dawid Schellingerhout, Brain Metastasis Study Group and Edward G. Shaw

recurrence in patients with metastatic brain tumors. In this paper we report the first experience with GliaSite brachytherapy—and the only prospective trial of brachytherapy—for brain metastasis. Clinical Material and Methods Trial Design Between August 2001 and April 2003, 13 institutions enrolled patients in a phase II clinical trial designed to evaluate the effectiveness of the GliaSite RTS for the delivery of local brachytherapy to the resection cavity in patients with single metastatic tumors. The GliaSite RTS device consists of a silicone variable