By Mary Ann Porucznik
With data on more than 3,600 procedures, AJRR ready for next steps
Participating hospitals have been submitting data to the American Joint Replacement Registry (AJRR) for just a few months, but already information on more than 3,600 primary and revision joint replacements has been assembled from eight different reporting sites (Table 1).
“We owe a huge debt of gratitude to our surgeon and staff champions at each site,” said David G. Lewallen, MD, who chairs the AJRR board of directors. “The successful completion of the pilot program represented a lot of work by many people. Our champions were instrumental in ensuring a high degree of participation and in identifying and helping us solve issues as they arose.”
“The supporting staff at all participating hospitals were critical in making this project a success,” added board member William J. Maloney, MD. “They helped us iron out our processes for both batch and manual data submissions on a case-by-case basis.”
The AJRR board of directors received an update report on the pilot project, covering lessons learned and data analysis, at their July 9, 2011, meeting. They also began to formulate strategies for outreach recruitment, expansion of registry staff, and efficient data collection methods as the registry moves from the data trial to full production.
“The AJRR has an aggressive timetable,” admitted Dr. Lewallen. “We hope to achieve 90 percent participation by hospitals by Oct. 1, 2013, so we are actively recruiting surgeon and staff champions across the country. We are also proceeding with plans to hire a medical director and to expand our support staff who will work with participating hospitals.”
The value of registries
Both registries and clinical studies have a place in improving patient outcomes and ensuring patient safety, noted AJRR board member Kevin J. Bozic, MD, MBA. Registries provide large, broad data sets, covering a wide range of surgeons and centers.
“Registries and clinical studies complement each other,” said Dr. Lewallen. “Clinical studies control for multiple variables, including patient-specific factors. They are also more sensitive in differentiating modes and causes of failure. A limitation of registries is that they typically do not include data on reasons for revision, other than failure of the device.
“The greatest value of registries,” he continued, “is in their ability to identify outliers in implants, hospitals, and surgeons. Registry data typically enable us to ask intelligent questions that require more study; they don’t give us answers.”
Data collection is a challenge, admits Randolph Meinzer, AJRR director of information technology. Currently, the AJRR is focused on collecting level-one data. Data collection at this level is an institutional responsibility and includes several core data elements, such as patient data (name, sex, date of birth, social security number, ICD-9 code for diagnosis), surgeon data (name, number of surgeries performed), procedure data (ICD-I code for type of surgery, date of surgery, patient age at surgery, laterality, implant), and hospital data (name, address, number of surgeries performed there). Each patient, surgeon, and hospital has a unique identifier, which enables index procedures to be linked to subsequent events, permits patients to access their own information, allows data to be linked to other databases, and helps maintain confidentiality.
Level two data, notes Dr. Lewallen, include variables that would enhance the value of the data analysis and permit risk adjustment, such as the patient’s body mass index and any comorbidities, as well as process of care data such as antibiotic prophylaxis. Level three data focus on outcomes and patient satisfaction, while level four data (such as radiographs) provide a more in-depth analysis of why and how implants or procedures fail. The AJRR data collection strategy is to start with level one data and add data elements incrementally.
“We are working with federal agencies in Washington, D.C., to clarify various interpretations of the data that can be released to a registry under current legislation,” said Dr. Lewallen. “This should help remove some of the institutional barriers that were identified during the pilot program.”
Unlike previous, time-consuming paper-based data entry systems, the AJRR will deploy several methods for data submission, including the following:
- extraction of registry data from administrative claim forms
- automated data submission for existing orthopedic registries
- custom interfaces to electronic medical records (EMR) and other healthcare IT systems to minimize data entry burden
Low-volume hospitals or those without EMR systems can enter data on a case-by-case basis, using a web-based application. The system will be fully compliant with the Health Insurance Portability and Accountability Act and will include software, data forms, and interfaces. Users who enter procedure information manually via the web form can select the appropriate ICD-9(10) code from a pull down menu that has a text descriptor of the procedure so they can match the procedure to the code.
“We are actively recruiting a medical director to supervise operations,” said Dr. Lewallen, “and more information on this effort will be available soon. We also are moving toward implementing systems that will enable a wide range of hospitals and systems to participate and submit data. Everyone who has been a part of this project to date is excited about the opportunities ahead and ready to move forward.”
About the AJRR
The American Joint Replacement Registry is a not-for-profit 501(c)(3) organization for data collection and research on total hip and knee replacements. The AJRR is a collaborative effort supported by the AAOS, the American Association of Hip and Knee Surgeons (AAHKS), the Hip Society, the Knee Society, hospitals, health insurers, government agencies such as the Centers for Medicare & Medicaid Services and the Agency for Healthcare Research and Quality, consumers, and medical device manufacturers. AAOS representatives to the AJRR include Thomas C. Barber, MD; William J. Maloney, MD; J. Wesley Mesko, MD; and E. Anthony Rankin, MD. Orthopaedic specialty society representatives include Kevin J. Bozic, MD, MBA (AAHKS); Terence J. Gioe, MD (The Knee Society); and David G. Lewallen, MD (The Hip Society). Additional members of the AJRR board of directors include two industry representatives, two payer representatives, and a patient/public representative; a hospital representative is yet to be appointed.