Dear Dr. Rodts,

In the September/October 2012 issue of Orthopaedic Nursing, Mary Atkinson Smith, DNP, FNP-BC, ONP-C, and William Todd Smith, MD, presented a review article titled "The American Joint Replacement Registry." In this article, Drs. Smith and Smith highlighted the need for a national total joint registry and described the rationale for and development of the American Joint Replacement Registry (AJRR).

While we appreciate the intent of the article, we must point out that many of the facts about the AJRR were either out of date or simply inaccurate. The authors have no affiliation with the AJRR nor did they contact the AJRR staff or board members to confirm their statements. We feel compelled to highlight many of the inaccuracies here.

First, the authors suggest that the Agency for Healthcare Research and Quality (AHRQ) is providing $12 million of support over 4 years for the AJRR. We currently do not receive any funding from AHRQ. In the fall of 2010, AHRQ awarded $12 million to the University of Massachusetts Department of Orthopaedics and Physical Rehabilitation to develop the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR) initiative. The FORCE-TJR project plans to study 30,000 total joint replacement patients from more than 100 orthopaedic surgeons across the United States with a focus on functional and outcomes research (Franklin, Allison, & Ayers, 2012). Collaborative efforts between FORCE-TJR and the AJRR are under way as it is the intent of both programs to enable FORCE-TJR participants to submit data to our national effort as well.

The financial structure of the AJRR at present is a multistakeholder funding model. The AJRR is a collaborative effort supported by orthopaedic surgeons via professional societies, including the American Academy of Orthopaedic Surgeons, the American Association of Hip and Knee Surgeons, The Hip Society, and The Knee Society. We also receive funding from health insurers and medical device manufacturers. The registry does not receive any federal funding at this time. It is anticipated that this funding model will only be in place through 2016. We are currently developing a plan for an independent structure, similar to other clinical data registries, which will include revenue from reports generated, grants for research, and subscription fees.

Second, the authors suggest that it is the intent of the AJRR to conduct comparative effectiveness research. While we agree that comparative effectiveness research studies can utilize registry data to answer specific questions, the primary strength of the AJRR will be in massive accumulation of Level 1 data on joint implants. Comparative effectiveness research studies will likely require a subset of submitting institutions to provide Level 2, 3 and even Level 4 data to accomplish this more detailed analysis.

Third, the final pilot project was conducted with eight institutions, not 16 as indicated by the authors. We originally narrowed down our final selection to 15 sites, from the original applicant pool, and seven institutions were unable to participate. Also, data were not collected for 3 months, as suggested. Once a pilot site began submitting data, the process has been ongoing. In addition, the pilot program was not concluded recently, but in the summer of 2011. The authors correctly stated that at the completion of the pilot program, the AJRR had collected data on more than 3,600 procedures. However, as of the date of publication of the Smith and Smith article, the AJRR had data on more than 30,000 procedures. Finally, the article did not discuss our progress since 2011. As of October 23, 2012, the AJRR is working with 79 hospitals across the country.

Fourth, Table 2 should indicate that the items were examples of elements in each of our levels and not the complete listing. Level 2 data are not solely body mass index, comorbidities, and antibiotic prophylaxis; those are but three of the items of Level 2. We will also be collecting surgical approaches, surgical complications, ASA scores, and Physician Quality and Reporting System measures. The authors correctly stated that collection of Level 2 data will allow for risk adjustment of Level 1 data.

Level 3 data will allow surgeons to capture patient-reported outcomes longitudinally. Our data collection portal will enable orthopaedic researchers to select the instruments that they would like to utilize with their patients. Patients will have the ability to complete the instruments online directly in to our patient portal. Surveys can be completed with assistance at a physician office, or by patients on their own. Current instruments that will be available include the SF-36 and SF-12, Hip disability and Osteoarthritis Outcome Score, Knee Injury and Osteoarthritis Outcome Score, Western Ontario and McMaster Universities Osteoarthritis Index, Oxford Hip and Knee Scores, Knee Society Knee Scoring System, Harris Hip Score, and American Academy of Orthopaedic Surgeons Hip and Knee Core Scale.

Level 4 data are also misrepresented as a comprehensive evaluation of how/why the failure of a procedure/implant occurs. Indeed, Level 4 data are not such an evaluation but rather only the inclusion of radiographic imaging data.

Fifth, the authors have also failed to cite some of the key scholarly manuscripts from our international colleagues in their section about international registries. Many critical findings have evolved from reports from the National Joint Registry for England and Wales and the Australian Orthopaedic Association National Joint Replacement Registry, which were integral in the discoveries surrounding the recent metal-on-metal total hip arthroplasty recalls, among other topics. Furthermore, international orthopaedic registries have increased their collaborative efforts over the past few years. In 2011, the U.S. Food and Drug Administration originated the International Consortium of Orthopaedic Registries and 2012 saw the First Annual Congress of the International Society of Arthroplasty Registers. For more information on international orthopaedic registry collaborations, we encourage your readers to review a supplemental issue of Journal of Bone and Joint Surgery from December 21, 2011.

While grateful for the efforts of nursing in particular to support the AJRR, we believe it is imperative that this important national effort is portrayed correctly, and appreciate the opportunity to respond.

The Board of Directors and Staff of AJRR strongly encourage those who are interested in participating to contact us at 847.292.0530 or visit our Web site at http://www.ajrr.net for more information.

Sincerely yours,

David G. Lewallen, MD

Chairman, Board of Directors, American Joint

Replacement Registry

Rochester, MN

Caryn D. Etkin, PhD, MPH

Director of Research, American Joint Replacement

Registry

Rosemont, IL

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