The deal made headlines. Healthcare giant Johnson & Johnson recently agreed to pay $2.5 billion to settle lawsuits over failures of its metal-on-metal ASR hip implant. In hindsight, the first sign of metal-on-metal implant failure was atypical patient-reported pain. Patients were the canaries in the coal mine, but no one was systematically documenting longitudinal patient-reported symptoms such as pain and physical function after surgery across orthopedic practices.
Dr. David Ayers is a professor and chairman of the orthopaedics and rehabilitation department at the University of Massachusetts Medical School.
The best data came from traditional implant registries, which define total joint replacement surgery's success based on implant longevity and low rates of repeat surgery. While implant registries serve an important function, they are limited in the ability to help detect early on how an implant is functioning based on patient concerns such as pain relief and functional gain.
Recalls of metal-on-metal hip implants might have happened earlier if we had the data-gathering tools that now exist to go beyond traditional implant registries. Those tools allow registries to include validated patient reported outcome measures, which provide an alert system for surgeons, patients, hospitals and insurance carriers, offering actionable data.
The U.K. has mandated pre- and post-surgical PROs for total joint replacements and will pay hospitals based on improved pain and function levels for patients based on these validated measures.
In the U.S., we now have FORCE-TJR, a federally funded effort by 125 surgeons to develop a comprehensive national database on total joint-replacement implants as well as PROs. The database of 30,000 validated pre- and post-surgery PROs will provide the much-needed early warning system.
FORCE-TJR is already helping us to identify where and why costly complications, infections, readmissions and revisions occur, and opportunities to establish best practices to avoid those outcomes. This database can provide surgeons and hospitals with valuable tools to manage and monitor outcomes, reduce variations, and complement lessons learned from traditional registries focused solely on implant longevity.
Dr. Patricia Franklin is a professor and director of clinical and outcomes research at the school.
As U.S. healthcare continues its march toward public reporting of outcome data, and reimbursement is increasingly based on the value of the care provided, success must be defined by outcomes of interest to the patient. We must be prepared to listen, analyze and understand what they are telling us.