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U.S. joint registry gets underway

By: Jennie McKee

By Jennie McKee

“We’re on the verge of making a U.S. joint replacement registry a reality,” said David G. Lewallen, MD, chair of the American Joint Replacement Registry (AJRR) board of directors, during an educational session held yesterday.

According to Dr. Lewallen, the registry plans to implement a pilot system for data submission this summer and hopes to begin accepting data in the fall.

“Then, over the next couple of years, we will work to achieve what has been identified by the international registry group as a true national registry, with more than 90 percent of hospitals reporting nationally,” he said.

“This is an aggressive time table for implementation,” said Dr. Lewallen, “but because the stakes are high and the benefits for our patients are even higher, we’re going to work hard to make this happen.”

David G. Lewallen, MD

Making progress on a vision
The mission of the AJRR is to foster a national center for data collection and research on total hip and knee replacement that has “far-reaching benefits to society, including reduced morbidity and mortality; improved patient safety, quality of care, and medical decision-making; reduced medical spending; and advances in orthopaedic science and bioengineering,” said Dr. Lewallen.

The AJRR was incorporated as a not-for-profit organization in Illinois in 2009. An AAOS board project team, led by Dr. Lewallen, established four workgroups: Steering, chaired by John J. Callaghan, MD; Governance & Management, under the direction of Daniel J. Berry, MD; Data, chaired by William J. Maloney, MD; and Regulatory/Legal/Privacy Issues, led by E. Anthony Rankin, MD.

In February 2010, 11 of the 13 members of the AJRR board of directors were approved. The board includes representatives from the AAOS, specialty societies, industry, and private payors. A hospital representative, nominated by the American Hospital Association (AHA), will be added, as will a patient/public representative.

Dr. Lewallen said that the AJRR is an exciting collaboration among several organizations. “Although support for the registry began at the Academy, this is not just an Academy registry,” he said. “This coalition of groups sees very clearly that good things can come from working together on this effort.”

Strategies for collecting data
Dr. Maloney, a driving force behind the creation of the registry, explained that capturing level 1 data, which includes information such as a patient’s name, date of birth, social security number, and sex, is crucial. The AJRR believes that collecting these data needs to be an institutional responsibility, reported by hospitals rather than individual surgeons.

“It’s important to have unique patient identifiers, said Dr. Maloney, “because we need to be able to tie an index operation to the patient, surgeon, and hospital. If we cannot do that, we cannot fulfill our goals from a patient safety standpoint.”

Additional level 1 data include the type of procedure, documented by the ICD-9 code; the date of surgery; and the type of implant.

“The implants are really the tricky part because there are a lot of implant codes,” he said. “We don’t have uniform barcoding right now, but it’s coming.”

He noted that the AJRR will work with hospitals to ensure that data collection and reporting does not add significant time and expense to current workflows.

“Fortunately, with the new electronic medical records systems that most large hospitals have, this is a much easier task,” he said.

Dr. Maloney acknowledged that the list of other variables the registry could collect to enhance the value of data analysis is endless.

“We need to find the least burdensome approaches to data collection,” he said. “[Level 1] data are very powerful, but other interesting data elements exist.”

The data committee, the AJRR board of directors, and hospitals in the registry will work together to decide whether additional data elements are added in the future.

Henrik Malchau, MD, PhD, helped develop the Swedish joint registry and has served as an advisor in the development of the AJRR. The American registry will be significant, he said, because so many procedures are performed in the United States annually. Registry data, he said, will serve as a “quality control system.”

“Feedback from the joint registry will make surgeons change their behavior,” he said. “We have plenty of good implants. We need to use them in an optimal way.”

Managing legal issues and confidentiality
Dr. Rankin noted that several legal issues must be settled before the joint registry begins collecting data.

“The AJRR does not qualify as a reporting organization,” said Dr. Rankin, “so if the AJRR shares data with manufacturers related to the performance of their devices—for example, data suggesting a device may cause serious injuries to patients—the manufacturer may be obliged to report that data to the U.S. Food and Drug Administration (FDA). The AJRR may voluntarily report, but it is not obligated to do so.”

Evaluating the effectiveness of specific devices also raises issues related to liability risks.

“The AJRR board of directors will need to consider risks and methods of mitigation, including insurance, [obtaining] manufacturer releases, or refraining from performing such evaluations,” said Dr. Rankin.

Dr. Rankin noted that the AJRR board of directors is carefully considering whether to participate in the FDA’s Sentinel Initiative, a collaborative effort between the FDA and private entities to develop a national electronic monitoring system for product safety.

Issues related to data protection, ownership, usage, and disclosure must also be addressed.

“The AJRR will also need to put agreements into place that establish the parameters of the data sharing relationship,” he said. “Parties to these agreements include device manufacturers, managed care organizations, government agencies, as well as other registries.

“In addition,” said Dr. Rankin, the AJRR will need to develop a standard patient authorization form, or seek institutional review board waivers at participating institutions.”

Dollars and cents
Funding is also a significant challenge, noted Dr. Lewallen, who said that the registry must become a self-sustaining endeavor.

The AJRR has received a total of more than $1 million in start-up funding and commitments from the AAOS, the American Association of Hip and Knee Surgeons (AAHKS), the Hip Society, the Knee Society, WellPoint, Blue Cross Blue Shield Association, and orthopaedic industry.

Robert E. Durgin, JD, an AJRR board member and senior vice president of quality/regulatory/clinical affairs at Biomet, noted that perhaps more important than industry’s commitment to contributing start-up funding is industry’s “commitment and willingness to fund its fair share of the sustained operations of the registry, with the proviso that other interested stakeholders also bear their fair share of that funding.”

A broad base of support
Members of the orthopaedic community, said Dr. Lewallen, are very interested in helping to create a national joint registry.

“We’ve begun discussions with orthopaedic surgeons and hospitals,” he said. “I don’t think we’re going to have trouble finding ready volunteers to help as we ramp up.

“We’re many months to years away from having data to report,” continued Dr. Lewallen, “but the work will need to begin right away to determine how we will proceed with the data that are collected and how they are shared.”

Mr. Durgin said that industry enthusiastically supports the registry, and David E. Mino, MD, MBA, orthopaedic surgery medical director for CIGNA Healthcare, noted that the payor community is “very much on board with making the AJRR a reality.”

“We want to see these data used effectively to improve and enhance quality and patient safety, and allow more data-driven information on the lifecycle of various implants,” said Dr. Mino.

Dr. Lewallen cautioned that although the data collected in the registry will yield information on whether an implant performs better or worse than other implants in a similar category, it will not provide answers about why.

“These data will allow us to search further for explanations, which may be multi-factorial,” he said. “All of the groups that participate—surgeons, hospitals, companies, even payors—have concerns about unfiltered data being misinterpreted, so the focus will be on transparency and clear reporting of what we learn, as well as fairness in how that information is reported.”

Although these issues are complicated, said Dr. Lewallen, he called it a privilege to work through them to obtain important data related to joint replacements.

“We will get the data out there in a way that serves the needs of patients and protects entities that are involved,” he said.

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