February 2002 Bulletin

National joint registry explored

Moving ahead with pilot project; legislation to be considered

By Carolyn Rogers

The feasibility of establishing a national total joint replacement registry in the United States was examined and debated by orthopaedic surgeons, government policy makers, implant manufacturers, health services researchers, and legal experts at a Dec. 10-11, 2001 workshop in Washington, D.C.

By the conclusion of the AAOS/Agency for Health Care Research and Quality (AHRQ) meeting, recommendations were made regarding the design of a pilot project for collection of registry data, as well as a proposal for funding. Additional recommendations called for a separate work group to develop policies, procedures, and a governance structure for a national registry. A final recommendation was to ask the AAOS Washington office to explore the feasibility of legislation on patient confidentiality and liability, as it relates to a national registry.

Debating the pros and cons

The Academy and AHRQ convened the workshop in order to gauge the level of support for, and the potential roadblocks to the establishment of such a registry. The ultimate goal of a national registry would be to assist surgeons in medical and surgical decision-making and, thereby, to reduce the morbidity and mortality associated with total joint replacements and to improve patients’ care and outcomes.

William W. Tipton Jr., MD, AAOS Executive Vice President, deemed the workshop "a very successful effort to bring together, for the first time, all the various players–including the Academy, industry and governmental agencies–to address an issue that is intended to increase quality and patient safety while decreasing related costs."

Sixty healthcare leaders participated in the workshop, including the AAOS presidential line, members of the AAOS Orthopaedic Registry Task Force and orthopaedic specialty society leaders. Health policymakers and regulatory affairs experts from AHRQ, the Centers for Medicare and Medicaid (CMS) and the Food and Drug Administration (FDA) also were in attendance, as well as representatives from national and international registries, executives from the leading implant manufacturers and health services researchers.

The prospect of having a national registry in place that could be used as an "early warning" system for implant failure was a key draw for many of the workshop participants. Health care cost savings that would result from the reduced number of revision surgeries is regarded as another critical benefit of such a registry.

Initially, however, there was some skepticism on the part of surgeons and industry, acknowledges William J. Maloney, MD, chair of the AAOS Osteoarthritis Registry Task Force. "By the end of the meeting, though, it was apparent that the registry–if done correctly and with the appropriate safeguards put into place–would be a very beneficial thing from the standpoint of patient safety and patient outcomes," he says. "Everyone could see how it could potentially lead to improved patient outcomes."

The workshop began with an overview of successful national registries operating in countries such as Sweden and Canada, as well as local registries, such as those at the Mayo Clinic in Rochester, Minn. Later, the ‘pros’ and ‘cons’ of a registry were assessed from the patient’s perspective, the physician’s perspective and the researcher’s perspective. The following day, the group explored issues relating to liability, governance, and who would have access to the data.

"From the patient’s perspective, a national registry is nothing but a positive," Dr. Maloney reports. "It could identify problems both from the technical side and the design-side of implants earlier than is currently being identified. So from the patient standpoint, it’s a winner. However, in this country, there are potential downsides–most of them being legal."

Issues related to liability, discoverability and patient confidentiality would need to be worked out, Dr. Maloney says. Those issues are currently being evaluated. Workshop participants also addressed key issues regarding contents of the database and data collection.

"We want the registry data to be used in a positive way to improve patient safety and outcomes," Dr. Maloney says, "not in a punitive way that would limit practices or lead to increased product liability or physician malpractice liability."

"The key is to keep it simple," Dr. Maloney says. "What we’re really interested in is ‘which implants are being put in which patients?’ and ‘which implants are coming out of which patients?’ The registry will track very basic data such as patient demographics, where is surgery is being done, who is doing the surgery, the type of implant, etc. It’s important to keep it simple–if you collect too much data, then compliance becomes an issue."

Pilot project

The pilot research project will be conducted through the cooperation of AAOS, AHRQ and CMS. The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and the FDA will provide additional input, and contact with industry will be maintained throughout.

According to Dr. Tipton, the next step is to "develop the pilot project, likely using Medicare data with type of implant and laterality added."

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