Misconceptions regarding the adequacy of best medical intervention alone for asymptomatic carotid stenosis.

BACKGROUND: Medical intervention (risk factor identification, lifestyle coaching, and medication) for stroke prevention has improved significantly. It is likely that no more than 5.5% of persons with advanced asymptomatic carotid stenosis (ACS) will now benefit from a carotid procedure during their lifetime. However, some question the adequacy of medical intervention alone for such persons and propose using markers of high stroke risk to intervene with carotid endarterectomy (CEA) and/or carotid angioplasty/stenting (CAS). Our aim was to examine the scientific validity and implications of this proposal. METHODS: We reviewed the evidence for using medical intervention alone or with additional CEA or CAS in persons with ACS. We also reviewed the evidence regarding the validity of using commonly cited makers of high stroke risk to select such persons for CEA or CAS, including markers proposed by the European Society for Vascular Surgery in 2017. RESULTS: Randomized trials of medical intervention alone versus additional CEA showed a definite statistically significant CEA stroke prevention benefit for ACS only for selected average surgical risk men aged less than 75 to 80 years with 60% or greater stenosis using the North American Symptomatic Carotid Endarterectomy Trial criteria. However, the most recent measurements of stroke rate with ACS using medical intervention alone are overall lower than for those who had CEA or CAS in randomized trials. Randomized trials of CEA versus CAS in persons with ACS were underpowered. However, the trend was for higher stroke and death rates with CAS. There are no randomized trial results related to comparing current optimal medical intervention with CEA or CAS. Commonly cited markers of high stroke risk in relation to ACS lack specificity, have not been assessed in conjunction with current optimal medical intervention, and have not been shown in randomized trials to identify those who benefit from a carotid procedure in addition to current optimal medical intervention. CONCLUSIONS: Medical intervention has an established role in the current routine management of persons with ACS. Stroke risk stratification studies using current optimal medical intervention alone are the highest research priority for identifying persons likely to benefit from adding a carotid procedure.

How the science of practice will improve evidence-based care.

This review article analyzes the present evidence-based medicine (EBM) algorithm, compares it to the science of practice (SOP) algorithm, and demonstrates how the SOP can evolve from a quality assurance and quality improvement tool into a clinical research tool. Using appropriately constructed prospective observational databases (PODs), the SOP algorithm can be used to draw causal inferences from nonrandomized data, perform innovative comparative effectiveness research, and generate reliable information that can be used to guide treatment decisions.

Quality Outcomes Database Spine Care Project 2012-2020: milestones achieved in a collaborative North American outcomes registry to advance value-based spine care and evolution to the American Spine Registry.

The Quality Outcomes Database (QOD), formerly known as the National Neurosurgery Quality Outcomes Database (N2QOD), was established by the NeuroPoint Alliance (NPA) in collaboration with relevant national stakeholders and experts. The overarching goal of this project was to develop a centralized, nationally coordinated effort to allow individual surgeons and practice groups to collect, measure, and analyze practice patterns and neurosurgical outcomes. Specific objectives of this registry program were as follows: "1) to establish risk-adjusted national benchmarks for both the safety and effectiveness of neurosurgical procedures, 2) to allow practice groups and hospitals to analyze their individual morbidity and clinical outcomes in real time, 3) to generate both quality and efficiency data to support claims made to public and private payers and objectively demonstrate the value of care to other stakeholders, 4) to demonstrate the comparative effectiveness of neurosurgical and spine procedures, 5) to develop sophisticated 'risk models' to determine which subpopulations of patients are most likely to benefit from specific surgical interventions, and 6) to facilitate essential multicenter trials and other cooperative clinical studies." The NPA has launched several neurosurgical specialty modules in the QOD program in the 7 years since its inception including lumbar spine, cervical spine, and spinal deformity and cerebrovascular and intracranial tumor. The QOD Spine modules, which are the primary subject of this paper, have evolved into the largest North American spine registries yet created and have resulted in unprecedented cooperative activities within our specialty and among affiliated spine care practitioners. Herein, the authors discuss the experience of QOD Spine programs to date, with a brief description of their inception, some of the key achievements and milestones, as well as the recent transition of the spine modules to the American Spine Registry (ASR), a collaboration between the American Association of Neurological Surgeons and the American Academy of Orthopaedic Surgeons (AAOS).

Carotid endarterectomy using regional anesthesia: technique and considerations.

Background: Carotid endarterectomy (CEA) is one of the most effective operations in minimizing stroke risk in both symptomatic and asymptomatic patients with carotid stenosis in the United States. Awake CEA with regional anesthesia may decrease both perioperative complications and length of hospital stay. Techniques of performing awake CEA is not often described in published literature. Objective: To describe our experience with CEA using regional anesthesia with a focus on patient selection, anatomic variations, and surgical technique including cervical regional block. We particularly focus on nuances of the awake approach. Methods: CEA using regional anesthesia is described in detail. Results: Successful use of regional anesthesia during CEA without complication. Conclusion: Regional anesthesia for CEA is an advantageous approach for cervical plaque removal in appropriate patients. Thoughtful patient selection, as well as understanding of anatomy and its variants, is required. Potential advantages and disadvantages are discussed.

The future of practice science: challenges and opportunities for neurosurgery.

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.

Launching the Quality Outcomes Database Tumor Registry: rationale, development, and pilot data.

OBJECTIVE: Neurosurgeons generate an enormous amount of data daily. Within these data lie rigorous, valid, and reproducible evidence. Such evidence can facilitate healthcare reform and improve quality of care. To measure the quality of care provided objectively, evaluating the safety and efficacy of clinical activities should occur in real time. Registries must be constructed and collected data analyzed with the precision akin to that of randomized clinical trials to accomplish this goal. METHODS: The Quality Outcomes Database (QOD) Tumor Registry was launched in February 2019 with 8 sites in its initial 1-year pilot phase. The Tumor Registry was proposed by the AANS/CNS Tumor Section and approved by the QOD Scientific Committee in the fall of 2018. The initial pilot phase aimed to assess the feasibility of collecting outcomes data from 8 academic practices across the United States; these outcomes included length of stay, discharge disposition, and inpatient complications. RESULTS: As of November 2019, 923 eligible patients have been entered, with the following subsets: intracranial metastasis (17.3%, n = 160), high-grade glioma (18.5%, n = 171), low-grade glioma (6%, n = 55), meningioma (20%, n = 184), pituitary tumor (14.3%, n = 132), and other intracranial tumor (24%, n = 221). CONCLUSIONS: The authors have demonstrated here, as a pilot study, the feasibility of documenting demographic, clinical, operative, and patient-reported outcome characteristics longitudinally for 6 common intracranial tumor types.

Neurosurgery residency and fellowship education in the United States: 2 decades of system development by the One Neurosurgery Summit organizations.

The purpose of this report is to chronicle a 2-decade period of educational innovation and improvement, as well as governance reform, across the specialty of neurological surgery. Neurological surgery educational and professional governance systems have evolved substantially over the past 2 decades with the goal of improving training outcomes, patient safety, and the quality of US neurosurgical care. Innovations during this period have included the following: creating a consensus national curriculum; standardizing the length and structure of neurosurgical training; introducing educational outcomes milestones and required case minimums; establishing national skills, safety, and professionalism courses; systematically accrediting subspecialty fellowships; expanding professional development for educators; promoting training in research; and coordinating policy and strategy through the cooperation of national stakeholder organizations. A series of education summits held between 2007 and 2009 restructured some aspects of neurosurgical residency training. Since 2010, ongoing meetings of the One Neurosurgery Summit have provided strategic coordination for specialty definition, neurosurgical education, public policy, and governance. The Summit now includes leadership representatives from the Society of Neurological Surgeons, the American Association of Neurological Surgeons, the Congress of Neurological Surgeons, the American Board of Neurological Surgery, the Review Committee for Neurological Surgery of the Accreditation Council for Graduate Medical Education, the American Academy of Neurological Surgery, and the AANS/CNS Joint Washington Committee. Together, these organizations have increased the effectiveness and efficiency of the specialty of neurosurgery in advancing educational best practices, aligning policymaking, and coordinating strategic planning in order to meet the highest standards of professionalism and promote public health.

Harmonized outcome measures for use in degenerative lumbar spondylolisthesis patient registries and clinical practice.

OBJECTIVE: The development of new treatment approaches for degenerative lumbar spondylolisthesis (DLS) has introduced many questions about comparative effectiveness and long-term outcomes. Patient registries collect robust, longitudinal data that could be combined or aggregated to form a national and potentially international research data infrastructure to address these and other research questions. However, linking data across registries is challenging because registries typically define and capture different outcome measures. Variation in outcome measures occurs in clinical practice and other types of research studies as well, limiting the utility of existing data sources for addressing new research questions. The purpose of this project was to develop a minimum set of patient- and clinician-relevant standardized outcome measures that are feasible for collection in DLS registries and clinical practice. METHODS: Nineteen DLS registries, observational studies, and quality improvement efforts were invited to participate and submit outcome measures. A stakeholder panel was organized that included representatives from medical specialty societies, health systems, government agencies, payers, industries, health information technology organizations, and patient advocacy groups. The panel categorized the measures using the Agency for Healthcare Research and Quality's Outcome Measures Framework (OMF), identified a minimum set of outcome measures, and developed standardized definitions through a consensus-based process. RESULTS: The panel identified and harmonized 57 outcome measures into a minimum set of 10 core outcome measure areas and 6 supplemental outcome measure areas. The measures are organized into the OMF categories of survival, clinical response, events of interest, patient-reported outcomes, and resource utilization. CONCLUSIONS: This effort identified a minimum set of standardized measures that are relevant to patients and clinicians and appropriate for use in DLS registries, other research efforts, and clinical practice. Collection of these measures across registries and clinical practice is an important step for building research data infrastructure, creating learning healthcare systems, and improving patient management and outcomes in DLS.

The impact of surgical specialty on outcomes for carotid endarterectomy.

BACKGROUND: Carotid endarterectomy (CEA) is one of the most frequently performed surgical procedures in the United States. Traditionally, this procedure has been performed by surgeons in at least four specialties. The purpose of this study was to examine the effect of surgeon specialty on the long-term outcomes of CEA among patients receiving the procedure in Pennsylvania. MATERIALS AND METHODS: Data included 17,635 patient admissions for CEA performed between 1995 and 1997, and patient readmission data for the 5-y follow-up period ending in 2002. Five-y outcomes for these patients were compared between vascular, cardiothoracic, general, and neurosurgeons. The primary outcome measures were mortality, stroke, combined stroke and mortality, transient ischemic attack (TIA), and re-occlusion of the ipsilateral artery. Secondary outcomes measured were length of stay and total charges. RESULTS: Using general surgeon as the reference group, and controlling for age, race, severity, and admission type, we found no significant difference across surgical specialties in overall mortality at 5 y post-CEA. Patients treated by vascular surgeons were found to have significantly fewer (P=0.012) strokes and significantly lower re-occlusion rate (P=0.021) at 5 y compared with patients of general surgeons. Patients treated by vascular surgeons also had significantly shorter hospital stay (P<0.0001) but significantly higher charges (P<0.0001) relative to general surgeons. CONCLUSIONS: These results suggest that there are significant differences in outcomes following carotid endarterectomy according to surgeon training. Additional research is needed to explore differences across specialties that may be driving outcomes and to explore the role of surgeon volume at the profession level and cross-volume effects on CEA outcomes.

The Honest Palm Sign: Detecting Incomplete Effort on Physical Examination.

BACKGROUND: We investigated a simple, novel diagnostic test for detecting incomplete effort during the motor portion of the neurological examination. METHODS: The results from the honest palm sign (HPS) were evaluated for 162 consecutive neuro-oncology patients who had undergone upper extremity strength testing. Deltoid, bicep, and wrist extensor strength was assessed in all patients. During the examination, patients were repeatedly encouraged to "try as hard as possible" and to "resist with all your strength." The absence of nail prints on the palms constituted a positive HPS test result (i.e., indicative of incomplete effort). The presence of nail prints constituted a negative HPS test result (i.e., indicative of full effort). RESULTS: A total of 162 patients were tested. Their mean age was 55.5 ± 14.9 years, the median Karnofsky performance scale score was 80 (range, 60-100), and 63 patients (39%) were men. Of the 162 patients, 102 (63%) had malignant gliomas, 28 (17%) had brain metastases, 21 (13%) had other primary brain tumors, and 11 (6.8%) had primary central nervous system lymphomas. Of the 162 patients, 48 (30%) had positive HPS test results. The test sensitivity (84.6%), specificity (75.2%), positive likelihood ratio (3.41), and negative likelihood ratio (0.205) were good. After excluding 33 patients with characteristics that rendered them unsuitable for testing, the results from the remaining 129 patients were analyzed. The sensitivity was unchanged (84.6%), but the specificity (96.6%), positive likelihood ratio (24.5), and negative likelihood ratio (0.16) improved dramatically. CONCLUSIONS: The HPS test is a simple, sensitive, and very specific test for detecting incomplete effort during the motor portion of neurological evaluations.