AANS Neurosurgeon : NPA Report

Volume 24, Number 2, 2015

Comprehensive Patient Registry to Inform National Treatment Benchmarks for Stereotactic Radiosurgery

Kathleen Craig

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The American Association of Neurological Surgeons (AANS) and the American Society for Radiation Oncology (ASTRO) have partnered to develop a national registry for stereotactic radiosurgery treatments. Stereotactic radiosurgery (SRS) is a minimally invasive approach that uses imaging guidance and stereotactic principles to deliver radiation to targeted cells within the body. SRS has become an important component in the treatment of some brain tumors, vascular malformations and functional abnormalities.

The SRS Registry will establish national benchmarks for SRS treatments that will provide both clinicians and patients the data needed to make informed treatment decisions. Gathering data from 30 diverse and high-volume sites, the registry will log the de-identified SRS treatment information of thousands of patients affected by brain metastases, benign brain tumors and arteriovenous malformations (AVMs). Several of the sites are beta testing the registry in June, with other participants quickly following.

“The registry will help us achieve major advances in the management of patients with complex problems such as brain tumors, vascular malformations and functional disorders. This potential for advancement is why the Neurosurgery Research and Education Foundation (NREF) has also come on board with additional funding,” commented Jason Sheehan, MD, PhD, FAANS, co-director of the SRS Registry. The mission of the NREF, a 501c3 primarily funded by neurosurgeons, is to support research and educational efforts that enhance and confirm the critical role neurosurgeons play in improving lives. “Our expectation for the registry is that it will, indeed, improve the quality of care that we deliver to our patients,” added Dr. Sheehan.

Brian Kavanagh, MD, MPH, ASTRO Health Policy Council chair, a radiation oncologist at the University of Colorado, is co-director of the SRS Registry. Dr. Kavanagh added, “Radiosurgery is one of the most important, high-value services we provide to a wide-range of patients for an assortment of benign and malignant cancers. The registry will give us the ‘big data’ needed refine our current technical and patient selection guidelines with nuanced observations that can only be derived from large patient cohorts who are followed prospectively in a registry platform.”

The goals of the registry include the following: defining national patterns of care in radiosurgery; improving health-care outcomes; supporting informed decision-making; and — potentially — lowering the cost of care delivery to patients. The registry may also allow physicians to more optimally provide care to a growing patient population afflicted with neurological problems requiring radiosurgical treatment.

Facilitating Novel Methods for High-quality Comparative Effectiveness Data
Developing a registry of this scope has been no small undertaking and would not have been possible without the financial support and collaboration of companies that recognized the value of the registry. Brainlab committed to the effort in April 2014, providing the majority of funding.

“Brainlab is committed to the SRS patient registry on many different levels, from clinical to technological to financial,” said Stefan Vilsmeier, CEO and founder, Brainlab. “We’ve developed software and infrastructure that will allow clinicians to access the registry and pinpoint desired treatment for a specific patient with specific criteria. The information compiled will include planning and outcomes data for thousands of de-identified SRS patients.”

In May 2015, the SRS Registry welcomed Elekta as a registry supporter. “We applaud AANS and ASTRO for their vision regarding the commitment to systematically using knowledge to drive quality improvement, and we appreciate that stereotactic radiosurgery has been prioritized within the scope of various registry initiatives given its vital role in the treatment armamentarium for neurological disorders,” said Catherine Gilmore-Lawless, vice president, clinical intelligence at Elekta.

Participating sites are abstracting data from multiple sources — patient charts, medical records, quality-of-life measures, such as the EQ-5D or other documents — and entering data, images or imaging reports into either Brainlab’s Quentry® system or Elekta’s MOSAIQ® system. Both of these systems upload collected data to the registry’s electronic data-capture system, which centralizes the data, allowing for analysis that sets the stage for truly meaningful patient outcome research.

The SRS registry is managed through the AANS’ data collection arm, NeuroPoint Alliance (NPA), which selected the internationally recognized company, Quintiles, to coordinate the project and collect and analyze the data. All storage, analysis and scientific supervision of the data are managed independently from either company platform. The first sites will accrue patients through Quentry by Brainlab, which has a fully mapped data dictionary. Elekta is progressing on mapping its data collection to the data dictionary and expects to deploy to sites by the end of June 2015.

This prospective registry is a quality improvement registry, exempt from institutional review board (IRB) review and the requirement for informed consent. NPA recommends that sites have their local IRB or Quality Improvement Board review the project description prior to implementation. If allowed, sites can avail themselves of the registry’s central IRB determination that the SRS Registry is not research. Exemption from informed consent helps increase the number of patients accrued in the registry and may eliminate potential bias in the data-collection process.

Quality Data
Registry co-directors Kavanagh and Sheehan emphasize that the registry goes far beyond a safety study. Looking at aggregate data regarding continuous longitudinal outcomes that include quality-of-life measures are critical to better informing patients of optimal individual options. “Patient-reported outcomes are extremely valuable in helping patients make informed decisions,” says Sheehan. “The registry is tracking patient-reported outcomes at routine intervals, three to six months after stereotactic radiosurgery. Tracking patients longer will make the data exceedingly meaningful.”

Risk-adjusting the data is also extremely important to the SRS registry in that it supports reporting patient outcomes with the highest possible accuracy, as various factors that influence outcomes are included within the data. While incorporating risk adjustment adds complexity and expense to any registry program, without looking at risk factors, it is impossible to fairly evaluate the experience of subpopulations of patients. The ability to better predict a patient’s likely experience with a treatment depends on the ability to report outcomes in similar patients.

The SRS Registry is incorporating quality checks within a high-quality, controlled validation methodology, including on-site auditing. The registry’s scientific board, comprised of equal representation from AANS and ASTRO, is working closely with the Quintiles team on quality assurance. Kavanagh notes, “We are aiming for the proper balance between capturing enough clinical details while not overburdening the participating clinicians. We hope that this type of Registry helps us move closer to a culture where clinicians collect analyzable data that informs us about quality in a manner that is seamlessly integrated into the process of patient care.”

“The initial phase is a three-year registry effort,” says Sheehan. “We are hopeful that we can continue the registry long-term. The more information we gain, the better guidance we can provide physicians and patients.”

Kathleen Craig is the deputy executive director of the American Association of Neurological Surgeons and NeuroPoint Alliance. The author reported no conflicts for disclosure.

One Comment

  1. Howard Landy, MD, FACS says:

    This registry is indeed a worthwhile undertaking, but to classify it outside of research in order to avoid the need for informed consent is disingenuous. Although the data is deidentified, and the risks are minimal, the study intends to follow subjects prospectively in order to develop generalizable knowledge. As a member of my medical school’s IRB for the past 14 years, I can assure you that we would classify this study as research and require signed informed consent.

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