Can the United States find its way?
Why doesn’t the United States have a national joint registry when other developed countries such as Sweden, Britain, and Australia have one? What are the benefits and risks of such a system? What role should the AAOS play in the formation of a joint registry?
Joshua J. Jacobs, MD, chair of the AAOS Council on Research, Quality Assessment, and Technology and a member of the AAOS Now editorial board, discussed the establishment of a U.S. joint replacement registry with five Academy fellows—Richard D. Coutts, MD; Richard F. Kyle, MD; David G. Lewallen, MD; Henrik Malchau, MD, PhD, and William J. Maloney, MD—who have been on the frontlines of this issue.
Dr. Jacobs: Who would benefit from a U.S. joint replacement registry?
Dr. Coutts: This is a “no-lose” situation. Everybody wins, especially the patient. Presuming that the registries will allow us to identify both well-performing implants and those that aren’t performing satisfactorily, as registries in other countries do, I feel quite confident that everyone would benefit. Surgeons benefit from receiving more timely data that could improve patient outcomes, and the manufacturers benefit by knowing how their implants are performing.
Dr. Kyle: Identifying prostheses that are prone to early failure so they can be removed from the marketplace will also save many secondary surgeries and revisions. That will benefit the payors such as insurance companies, the Centers for Medicare and Medicaid Services (CMS), and patients. One of the major costs of total joint replacements is revisions of failed prostheses.
Dr. Jacobs: What has been the experience in other countries with national registries and what have we learned from them?
Dr. Malchau: In the Scandinavian countries, the feedback that surgeons receive from the data collected quickly improves the quality of the outcome—in essence creating a quality control system.
Dr. Maloney: During the past 4 or 5 years, registries have generated a number of research hypotheses. The high-level data from the Scandinavian registries has enabled researchers to ask important questions. This is one of the unrecognized benefits to the orthopedic research community.
Dr. Coutts: Data from the Scandinavian registries showed that adding antibiotics to cement lowered the rate of infection following total hip replacement. This type of finding requires a tremendous amount of data from a large number of patients. Data from the Australian registry on hip resurfacing suggested that this procedure was appropriate for one subset of candidates but not for others. The registry can help fine-tune the devices and services we provide to our patients.
Dr. Maloney: Registries provide relatively “real time” data. Clinicians and scientists frequently deal with retrospective data that typically lags at least 3 years behind when the surgery was actually done. Problems almost have to be catastrophic for us to recognize them as they are occurring.
Dr. Jacobs: What are the obstacles to the establishment of a national registry?
Dr. Kyle: Cost is a major obstacle. It’s difficult to get all of the various medical centers and institutions to report their data into a central repository. Getting CMS to fully understand the benefits of a national joint registry is especially difficult, even though total joint replacements (TJR) are their number one cost in the area of orthopaedics.
Legal issues could present a substantial obstacle if the collected data is not properly protected. The Patient Safety and Quality Improvement Act of 2005 made it possible to form patient safety organizations (PSOs) to house registry information that is protected. The regulations are being written by the Agency for Healthcare Research and Quality (AHRQ), and the finished draft is now being reviewed by the Office of Management and Budget. Once the regulations are published, a PSO can house the joint registry information in a protected fashion, enabling the formation of a joint registry to proceed.
Dr. Lewellan: U.S. manufacturers, hospitals, and surgeons are all concerned about how the composite data could be used, especially given our legal system. Health Insurance Portability and Accountability Act (HIPAA) regulations could make implementing a registry virtually impossible because of data-gathering protections. With 5,000 hospitals doing TJRs, a requirement for separate business agreements and institutional review board approvals with each individual hospital would be a gargantuan burden.
Manufacturers in an already highly competitive marketplace are understandably concerned about how registry data might affect their financial interests. If one manufacturer has a reasonably good implant, but another manufacturer has a slightly better one, the company may not want that data readily available.
Dr. Malchau: Orthopaedic surgeons are also concerned that data from the registry will be used to monitor their performance as surgeons. They are afraid of being excluded from doing certain procedures. We need to address this problem and assure surgeons that this will not be the case.
Dr. Jacobs: What is the AAOS strategy to catalyze the establishment of a national registry?
Dr. Lewellan: The AAOS is strongly committed to the establishment of a national registry because it will greatly benefit our patients. For the past decade, the Academy has been involved with various governmental agencies and industries, and I currently chair the American Joint Replacement Registry Oversight Board.
The number one concern has been the medical-legal exposure. As Dr. Kyle mentioned, passage of the Patient Safety and Quality Improvement Act was a critical development that made a registry much more feasible. Since passage of the legislation in 2005, AAOS has been anxiously awaiting the release of the regulations that will result from that law before formally establishing a national registry. AAOS staff and physicians have attended all of the public hearings held by the AHRQ on the PSO legislation, and last year, we drafted and presented a business plan to CMS.
AAOS now faces the decision of whether to continue to wait for those regulations to be approved or to begin moving ahead with formation of a not-for-profit American Joint Registry project as an adjunct of our organization without protecting regulations in hand.
The business plan calls for an independent foundation to administer both the data collection and recording of referrals. The costs would be borne in part by the Academy; over the longer term, participating hospitals would pay for the reports generated.
Dr. Kyle: AAOS has made some major efforts in the last couple of years to partner with CMS on ways to save by creating efficiencies within the system. One of the greatest examples is the joint registry. Over the long haul, partnering with CMS would be of great value.
Dr. Malchau: I’ve been working with Virginia and Connecticut. Virginia has successfully started its own pilot registry. It has procedures in place to identify and track data and has addressed the legal issues of running a registry in Virginia. Connecticut has a similar model. As an alternative to implementing a national registry all at once, perhaps we should consider phasing in state registries over a period of time.
Dr. Jacobs: Should the registry contain only so-called level 1 data? If so, how can additional information about outcomes (other than the occurrence of revision surgery) be obtained?
Dr. Maloney: Based on the Scandinavian experience, a tremendous amount of value can be gained from level 1 data, which include “patient identifiers” such as gender, diagnosis, and age; surgeon’s name and the institution where the joint replacement was performed; the type of implant and whether it is a right or left joint replacement. We have also discussed adding critical data that relate to hospital accreditation, such as documenting the administration of antibiotic prophylaxis.
Level 2 data contain “patient factors” including comorbidity, deep venous thrombosis prophylaxis, and pulmonary embolism. Level 2 data would tell us whether bone cement was used and whether it contained antibiotics. Level 3 data comprise standard “outcome data”—Western Ontario and McMaster Universities and Harris Hip scores. That data would be more useful for investigators involved in prospective clinical studies that could use the registry for data collection.
A joint registry would increase efficiency for U.S. hospitals and surgeons to help meet Joint Commission and Surgical Infection Prevention project requirements.
Dr. Coutts: Level 1 data would also include patient mortality. In a perfect world, we would love to collect level 2 and 3 data, but that’s not practical. If a voluntary registry were established, researchers and surgeons could provide level 2 and level 3 data on their own initiative. These data would not be as extensive as the level 1 data that would compose a national registry, but these voluntary subsets could provide very valuable information.
Dr. Jacobs: Dr. Malchau, is the Swedish registry, which for years has focused on level 1 data, now collecting level 2 and level 3 data?
Dr. Malchau: Correct. Sweden is now collecting outcomes data. Patient data now include a basic “case mix index” that enables identification of comorbidity factors and therefore increases the validity of statistical comparison among implants, for example, or surgeons. The Swedes also use a short form general health questionnaire. Our goal is to continuously participate in the quality improvement project. Every Scandinavian clinic has electronic medical records (EMR). All the needed information can be captured in the EMR. The infrastructure is in place to probably go beyond that as well. Improvements in information technology will make it much easier to capture the data we need in the future.
Dr. Jacobs: Final comments?
Dr. Kyle: I had the opportunity to travel to almost all the international orthopaedic association meetings this past year. The United States is one of the few developed countries that does not have a joint registry. Sweden, South Africa, Canada, and Great Britain all have joint registries.
Australia’s conference was particularly impressive. A number of papers were presented—even those sponsored by industry—and the results of those studies were reported. The Total Joint Registry also reported its data, which sometimes refuted the findings of the studies. For example, one company-sponsored paper focused on a prosthesis that was said to have a 98 percent long-term success rate. The joint registry noted that 20 percent of revision surgeries involved that prosthesis. That’s real-time information for surgeons.
This type of collective, nonbiased information will be of tremendous value to payors, surgeons, and patients. Patient safety and care is our number one goal.
Dr. Maloney: To paraphrase Jonathan Black, I think we are now involved in one huge clinical experiment. No one is currently tracking the data and that is unfortunate. We do not have an excuse for not having a national joint registry because we are clearly the world leaders in joint replacement. We all know the approval process for devices, and that process does not guarantee a successful outcome. The final outcome is a combination of surgical technique and implant technology. Only by collecting large amounts of appropriate data will we be able to improve outcomes for our patients. The time has come. We need to move forward.
A symposium on the impact of national joint replacement registries on hip and knee surgeries was held during the 2008 Annual Meeting. Watch for a summary article in a future issue of AAOS Now.
Annie Hayashi is the senior science writer for AAOS Now. She can be reached at email@example.com