UMass Medical School has enrolled more than 100 doctors and 6,000 patients in a first-of-its-kind national database of total joint replacement recipients in which the patients report ongoing updates on their quality of life, including pain, stiffness and function.
Funded by a $12 million, four-year grant by the Agency for Healthcare Research and Quality, the study will provide valuable data to improve outcomes and identify best practices in joint replacements.
Primary investigator Patricia D. Franklin, MD, MBA, MPH, professor of orthopedics & physical rehabilitation and family medicine & community health, said putting the focus on the patient—rather than the implant—is succeeding. Two years into the study, initial data is coming in strong, she said.
“The concept is working: we have more than 95 percent of the data complete on the patients we already have enrolled,” Dr. Franklin said. “This patient-centered research is a paradigm shift. It is an important new direction for research.”
An editorial published in the Sept. 25 edition of the Journal of American Medical Association provides a close look at the Function and Outcomes Research for Comparative Effectives in TJR (FORCE-TJR,) led by a broad team of UMMS researchers from the departments of Orthopedics & Physical Rehabilitation and Quantitative Health Sciences, and the Division of Preventive and Behavioral Medicine in the Department of Medicine, in cooperation with a nationwide network of surgeons.
“Despite the proven effectiveness of total joint replacement (TJR) surgery in relieving advanced knee and hip arthritis pain, TJR outcomes have come under intense public scrutiny in recent years,” according to the JAMA commentary, written by David Ayers, MD, the Arthur M. Pappas, MD, Chair in Orthopedics, chair and professor of orthopedics & physical rehabilitation; Jeroan Allison, MD, MS, professor of quantitative health sciences; and Franklin. “The 2010 recall of ASR metal-on-metal hip implants heightened awareness of the importance for implant safety surveillance for this high-cost and high-use procedure and exposed the need for a national systematic patient-centered outcomes monitoring system.”
Dr. Ayers said previous data on joint replacements centered on the mechanics of the implant—primarily whether it had to be revised. As a result, previous joint replacement registries established overseas have been implant centered, not patient centered.
“Our focus is that patient-reported outcomes are extremely important,” he said. “Doctors need to use validated questionnaires to assess the patient’s pain and function before and after the total joint replacement. These are termed patient-reported outcome measures. Patient-focused registries provide real-time feedback on patient activity, pain and function. This provides valuable information that is increasingly being recognized by the FDA, and the Centers for Medicare & Medicaid Services. Previously, implant registries only recorded whether the implant was removed.”
“Revision joint replacement is a crude end point and unnecessarily late,” Ayers added. “On the rare occasion when a patient has continued pain and little improvement in function after a total joint replacement it is hard to call the operation a success, even if the implant stays in place.”
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