NPA’s Quality-focused Registries Support Improved Quality of Care

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Clinical data registries have become valuable tools to support evidence development, performance assessment, comparative effectiveness studies and adoption of new treatments into routine clinical practice. As a recognized participant in the Surgical Quality Alliance (SQA), the NeuroPoint Alliance (NPA) focuses its clinical registry efforts on promoting the quality of patient care and providing physicians with the means to assess risk-adjusted measures of the value and efficacy of treatment responses. In collaboration with over 20 surgical and anesthesia specialty societies in the SQA, the NPA works to define the principles of surgical quality measures, develop meaningful tools for quality improvement and provide a forum for shared and coordinated efforts among the specialties to monitor and respond to Federal and private sector initiatives.

NPA’s quality-focused registries continue to support improved quality of care through the aggregate experience of other patients represented in the registry, primarily by assisting in the understanding of patient perspectives on clinical outcomes and by providing the ability to compare the relative effectiveness of various therapeutic interventions. NPA’s initial registry project, the Quality Outcomes Database (QOD) for spine and neurovascular procedures, is a very successful registry that is now evolving to include specific risk calculators that will help to guide treatment decisions in addition to accumulating provider outcomes benchmarked against national-level data. As opposed to the limited perspective of clinical status, QOD’s outcomes measurements focus on patients’ functional status, which is why patients seek care (1).

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Recognizing that outcomes are reflective of patient care that can sometimes involve multiple specialties, NPA expanded from a neurosurgery-driven focus to a more inclusive model that involves all individuals and organizations delivering spine care. As the data collection arm of the American Association of Neurological Surgeons (AANS), NPA has developed several coordinated multi-specialty registry efforts, among them the new all-care Spine Quality Outcomes Database (SQOD) developed with the American Academy of Physical Medicine and Rehabilitation (AAPM&R). SQOD will track surgical and non-surgical outcomes by initially focusing on a specific diagnosis or symptom set while demonstrating the quality and value of treatments.

One of the challenges addressed in the SQOD registry program is the harmonization of outcome measures across diverse medical specialties such as neurosurgery and physiatry. Physiatrists and neurosurgeons are natural partners in caring for patients suffering from spine disorders throughout the continuum of care. According to the Centers for Disease Control (CDC), back pain is one of the most common health complaints, affecting more than one in four adults every year and a popular reason for physician visits. The specialties of physical medicine, rehabilitation, orthopaedics and neurosurgery serve a large portion of spine patients in the U.S. The SQOD registry will follow both surgical and nonsurgical patients longitudinally and, collectively, the data have the ability to advance the understanding of this ever-growing patient population. “Physicians practicing spine medicine currently represent the largest segment of our specialty and Academy membership,” commented Gregory M. Worsowicz, MD, MBA, immediate past-president of AAPM&R. “Their work is critical for improving the health of the spine patient population as well as for the future of our specialty. Through this registry and data, we seek to demonstrate the clinical expertise and impact physical medicine and rehabilitation physicians have on the lives of these patients. This unique collaboration with AANS also showcases a key to the physiatric approach to medicine: team-based care.”

The objectives for the SQOD registry are closely aligned to health care’s shift towards value-based payments. The Medicare Access & CHIP Reauthorization Act of 2015 (MACRA) established new mandates that will have a direct effect on the physician quality reporting programs. Payment adjustments are scheduled to be implemented in 2019 tied to a 2017 performance period. AAPM&R and the AANS are preparing the registry for utilization for the 2017 reporting period. Physicians who participate in the registry will meet reporting requirements while having the capacity to advance quality improvement and research needs.

Building on the continued success of the QOD registry initiative, NPA followed a similar approach with the creation and implementation of a national stereotactic radiosurgery (SRS) registry with administrative and financial support from corporate partners Brainlab and Elekta, and the American Society for Radiation Oncology (ASTRO). SRS represents a multidisciplinary approach to the delivery of ionizing high-dose radiation to treat a wide variety of disorders. Much of the radiosurgical literature is based upon retrospective single-center studies along with a few randomized controlled clinical trials. More timely and effective evidence is needed to enhance the consistency and quality of clinical outcomes achieved with SRS. Initial plans were devised for a three-year effort encompassing high-volume SRS centers across the country. Device-specific web-based data-extraction platforms were built by the corporate partners. Data uploaders were then used to port the data to a common repository that is subject to regular audits for completeness and veracity to ensure data fidelity. Data governance and analysis are overseen by an SRS board comprising equal numbers of representatives from the AANS, NPA and ASTRO. Over time, quality outcome assessments and post hoc research can be performed to advance the field of SRS. Stereotactic radiosurgery offers a high-technology approach to treating complex intracranial disorders. Improvements in the consistency and quality of care delivered to patients who undergo SRS should be afforded by the national registry effort that is currently underway (2).

NPA has consistently demonstrated strength in developing collaborative projects with multiple organizations to achieve a shared vision. As a result, the Food and Drug Administration (FDA) is currently in discussions with NPA, the Society of NeuroInterventional Surgery (SNIS) and the AANS/CNS Section on Cerebrovascular Surgery to establish a collaborative registry project that would provide post-market surveillance services to the FDA and industry. The Medical Device Epidemiology Network (MDEpiNET) is a national planning board that is tasked with evaluating regulatory-grade data sources for the establishment of a coordinated registry network for medical device studies to identify complications. Established registries, such as those developed by SNIS and NPA, provide the potential to enhance post-market device evaluation in a cost-effective and standardized manner.

Other current projects include the development of a proposal with the Parkinson Study Group (PSG) for the establishment and implementation of a Deep Brain Stimulation (DBS) registry for Parkinson disease (PD) that is focused but scalable to a large number of participating sites and expandable over time. The Registry for Advancement of DBS therapy in Parkinson disease (RAD-PD) is a registry project with the ultimate goal of improving the quality and outcomes of DBS therapy for individuals with PD, through targeted data collection in the pre-operative, operative and post-operative phases of DBS treatment. The specific aims of the project are to define the best practices surrounding DBS therapy, the adverse events that may impact outcomes in DBS for PD, the natural history of PD after DBS and the health economics and disparities surrounding DBS treatment.

DBS for Parkinson’s disease is currently the surgical standard of care for patients with disabling symptoms, with over 100,000 patients implanted worldwide. Patients who are experiencing troublesome motor complications (motor fluctuations and levodopa-induced dyskinesias) or treatment-refractory tremor are generally considered for DBS therapy. Historically, the therapy has been reserved for patients with “advanced disease”. Although this implies individuals with a longer disease duration, it has been poorly defined. In 2016, however, the FDA-labeling for this therapy was updated to specify that patients who have had PD for at least four years and have experienced motor complications for four or more months, may be considered candidates. In this context, there is great potential for a marked increase in use of this therapy in the coming years. DBS teams currently do not have clear evidence-based guidelines for target selection in individual patients, and may make therapeutic decisions based on a variety of factors including past experiences, anecdotal or uncontrolled evidence, or personal preferences. This heterogeneity of practice across centers could in turn lead to variability in outcomes after DBS.

In the real world of DBS practice, stimulation-induced side effects are not always well documented and diverse techniques may be used to manage them. There are limited evidence-based recommendations for how or whether to use one technique over another. Randomized control trials are impractical due to large numbers of subjects that would be required as well as difficulties with blinding, leading them to be challenging to design as well as cost-prohibitive. Considerable heterogeneity still exists across implanting centers in terms of patient selection, DBS target selection, surgical technique, post-operative programming and medication management. Additionally, although data supporting improvement in quality of life in PD patients following DBS therapy exists, specific aspects of therapeutic benefit such as patient quality-adjusted life years, economic impact and cost efficiency have been less well documented. Therefore, a large, prospectively collected registry of real-world practices of DBS therapy in PD, including both clinically-oriented and patient-centered reporting, as well as collection of socioeconomic variables, would be highly informative. Data mining of this registry data could significantly broaden the knowledge base about the impacts of DBS (benefits and complications/side effects), establish best treatment practices and therapeutic efficacy across a heterogeneous population and better define the natural history of PD after DBS, in a way that will be more relevant to a diverse practice.

Through a range of multi-specialty registry projects, NPA remains committed to its efforts to provide physicians from a variety of medical specialties with the means to demonstrate the value and quality of patient care through the centralized collection and analysis of outcomes data.

References
1. Porter, M. E., Larsson, S., & Lee, T. H. (2016). Standardizing patient outcomes measurement. New England Journal of Medicine, 374(6), 504-506

2. Sheehan, J. P., Kavanagh, B. D., Asher, A., & Harbaugh, R. E. (2016). Inception of a national multidisciplinary registry for stereotactic radiosurgery. Journal of Neurosurgery, 124(1), 155-162

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