Full article reprinted from "The Gray Sheet" - July 13, 2009
The Agency for Healthcare Research and Quality plans to spend $12 million over four years on a clinical registry of orthopedic devices, drugs and procedures. Find out more...
Full article reprinted from "The Gray Sheet" - July 13, 2009
The Agency for Healthcare Research and Quality plans to spend $12 million over four years on a clinical registry of orthopedic devices, drugs and procedures.
In a 1 Request for Application dated July 6, AHRQ says it plans to grant $3 million a year annually for four years to a nonprofit organization to develop a prospective clinical registry of orthopedic devices, drugs, and procedures.
The goal of the registry is to "generate and advance" scientific knowledge about hip and knee replacement procedures and devices, AHRQ explains.
"An orthopedic registry that captures real world experience with these devices and procedures would be a valuable resource to inform decision makers (patients, physicians, hospitals and policy makers) about comparative effectiveness and will ultimately serve to improve patient outcomes, quality of care, and safety."
The agency notes that new orthopedic devices and procedures are often initially promoted by "surgeon enthusiasts of the particular device/procedure who are some of the best performing surgeons," but that the real-world clinical performance of the devices outside of the leading centers that participate in pre-market clinical trials is difficult to evaluate.
AHRQ "envisions utilizing a practice-based orthopedic registry across a broad provider network as one of the potentially most effective and productive approaches to develop scientific evidence regarding the short- and long-term benefits and harms of implantable orthopedic devices and other related services."
The winning applicant will be expected to form a Research and Data Coordinating Center guided by a registry steering committee, and to secure the participation of at least five clinical centers at institutions performing a high volume of hip and knee replacements.
Applicants should plan for at least three "core research studies" that will be conducted as part of the registry. Possible studies, AHRQ says, include an analysis of the clinical, demographic, social, economic and other factors that affect the long-term performance of the devices and the quality of life of patients receiving them.
Another core research study AHRQ suggests is an assessment of why joint replacements fail, with a report on the best methodological approaches to the assessment and consequences of joint failure.
The registry should take advantage of existing local registries, AHRQ says.
Funding for the registry will come from AHRQ's Effective Healthcare Program, created by the 2003 Medicare Prescription Drug, Improvement, and Modernization Act.
Applications to AHRQ are due Sept. 23, followed by four months of peer review. The agency hopes to start the registry about four months after the peer review is complete.
Support For Registry Has Been Building For Years
The American Academy of Orthopedic Surgeons has been lobbying for a federally supported national hip and knee replacement device registry for years. The United States is one of the only developed nations without a national joint replacement database.
Members of Congress, as well, have recognized the need for a registry. On June 10, Reps. Bill Pascrell, D-N.J., and Lloyd Doggett, D-Texas, introduced the National Knee and Hip Replacement Registry Act of 2009, which would create a nine-year knee and hip replacement registry within AHRQ with data collected through "existing federal reporting requirements," such as Medicare claims, plus voluntary data submissions from practitioners.
The AAOS says it supports the intent of the bill, but does not believe a registry that relies so heavily on Medicare patient data will address the need to track the performance of the devices in patients not old enough for Medicare. About 40% of the joint replacement population is under 65, according to AAOS. The group also says that nine years is not enough time to study the long-term performance of the devices.
AAOS has allocated about $800,000 of its own money toward the establishment of the American Joint Replacement Registry to capture 90% of all joint replacement patient data. "AJRR will be an independent registry developed, implemented, and operated by various stakeholders, including orthopedic surgeons with expertise in joint replacement, patient advocates, implant manufacturers, hospitals, and government agencies," AAOS says.
- Reed Miller
To start your 30-day, risk-free trial of "The Gray Sheet", contact Elsevier Business Intelligence's Customer Care team toll free at 800-332-2181 or by email at [email protected].
To find out about more about more about Elsevier Business Intelligence's medical device publications and databases, multi-user access and/or advertising with Medical Devices Today, please contact Sean Smith at 240-221-4535 or [email protected].
