Harbaugh, Robert E.

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 Quality Outcomes Database (QOD), formerly known as the National Neurosurgery Quality Outcomes Database (N 2 QOD), 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).

Abstract BACKGROUND Modern healthcare reforms focus on identifying and measuring the quality and value of care. Patient satisfaction is particularly important in the management of degenerative cervical radiculopathy (DCR) since it leads to significant neck pain and disability primarily affecting the patients’ quality of life. OBJECTIVE To determine the association of baseline and 12-mo Neck Disability Index (NDI) with patient satisfaction after elective surgery for DCR. METHODS The Quality Outcomes Database cervical module was queried for patients who underwent elective surgery for DCR. A multivariable proportional odds regression model was fitted with 12-mo satisfaction as the outcome. The covariates for this model included patients’ demographics, surgical characteristics, and baseline and 12-mo patient reported outcomes (PROs). Wald-statistics were calculated to determine the relative importance of each independent variable for 12-mo patient satisfaction. RESULTS The analysis included 2206 patients who underwent elective surgery for DCR. In multivariable analysis, after adjusting for baseline and surgery specific variables, the 12-mo NDI score showed the highest association with 12-mo satisfaction (Waldχ2-df = 99.17, 58.1% of total χ2). The level of satisfaction increases with decrease in 12-mo NDI score regardless of the baseline NDI score. CONCLUSION Our study identifies 12-mo NDI score as a very influential driver of 12-mo patient satisfaction after surgery for DCR. In addition, there are lesser contributions from other 12-mo PROs, baseline Numeric Rating Scale for arm pain and American Society of Anesthesiologists (ASA) grade. The baseline level of disability was found to be irrelevant to patients. They seemed to only value their current level of disability, compared to baseline, in rating satisfaction with surgical outcome.

Study Design. This study retrospectively analyzes prospectively collected data. Objective. Here we aim to develop predictive models for 3-month medical and surgical readmission after elective lumbar surgery, based on a multi-institutional, national spine registry. Summary of Background Data. Unplanned readmissions place considerable stress on payers, hospitals, and patients. Medicare data reveals a 30-day readmission rate of 7.8% for lumbar-decompressions and 13.0% for lumbar-fusions, and hospitals are now being penalized for excessive 30-day readmission rates by virtue of the Hospital Readmissions Reduction Program. Methods. The Quality and Outcomes Database (QOD) was queried for patients undergoing elective lumbar surgery for degenerative diseases. The QOD prospectively captures 3-month readmissions through electronic medical record (EMR) review and self-reported outcome questionnaires. Distinct multivariable logistic regression models were fitted for surgery-related and medical readmissions adjusting for patient and surgery-specific variables. Results. Of the total 33,674 patients included in this study 2079 (6.15%) reported at least one readmission during the 90-day postoperative period. The odds of medical readmission were significantly higher for older patients, males versus females, African Americans versus Caucasion, those with higher American Society of Anesthesiologists (ASA) grade, diabetes, coronary artery disease, higher numbers of involved levels, anterior only or anterior–posterior versus posterior approach; also, for patients who were unemployed compared with employed patients and those with high baseline Oswestry Disability Index (ODI). The odds of surgery-related readmission were significantly greater for patients with a higher body mass index (BMI), a higher ASA grade, female versus male, and African Americans versus Caucasians; also, for patients with severe depression, more involved spinal levels, anterior-only surgical approaches and higher baseline ODI scores. Conclusion. In this study we present internally validated predictive models for medical and surgical readmission after elective lumbar spine surgery. These findings set the stage for targeted interventions with a potential to reduce unnecessary readmissions, and also suggest that medical and surgical readmissions be treated as distinct clinical events. Level of Evidence: 3