Device registries can be source of crucial data
Regarding “FDA gets push for device registries” (Sept. 8, p. 14), hip and knee implant registries incorporating refined data for comparative effectiveness, quality monitoring and public reporting are clearly necessary. As implant designs and materials mature, and survival times lengthen, patient attributes and risk factors are emerging as key factors in predicting implant survivorship and functional outcomes. Information such as risk adjustment at the time of surgery—including patient-reported symptoms—to understand thresholds for revision would be most useful.
The Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR) program has established a novel TJR registry with more than 21,000 patients enrolled from 136 surgeons in 22 states, with hundreds more patients enrolled weekly. FORCE-TJR is the first U.S. national cohort of TJR patients representing all regions of the U.S., with varied practice settings (e.g., urban and rural, high and low volume) to collect comprehensive TJR outcome data. Data are collected directly from patients—including patient-reported outcomes of pain and function, early post-operative adverse events and implant failures—assuring more than an 85% response for valid, longitudinal analyses.
The CMS initiated public reporting of post-TJR readmissions and complications in 2014. To monitor quality, arthroplasty surgeons need timely and riskadjusted data to monitor outcomes to meet or exceed national goals. Our unique national database and riskadjustment models allow FORCE-TJR to provide comparative valuable feedback to member surgeons to guide practice, support quality-improvement efforts and meet regulatory requirements such as the CMS Physician Quality Reporting System and value-based proposals for accountable care. Quarterly reports address three critical questions that previously surgeons could not answer: How do my patient risk factors such as BMI and comorbidities compare to other surgeons? How does the timing of patient surgery as described by pain and functional limitations compare to national practice? And is the degree of pain relief and improved function in my patients comparable to the national norm? Sitespecific comparisons of risk factors and outcomes allow surgeons to understand the similarities and differences among their patients and practices.
Dr. David Ayers and Dr. Patricia Franklin Department of orthopedics and physical rehabilitation University of Massachusetts Medical School, Worcester