Device registries can be source of crucial data, and other letters

Regarding “FDA gets push for device registries”, 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 risk-adjusted data to monitor outcomes to meet or exceed national goals. Our unique national database and risk-adjustment 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? Site-specific comparisons of risk factors and outcomes allow surgeons to understand the similarities and differences among their patients and practices.

Regarding the story “AMA pleads for more user-friendly EHRs”, if electronic health records were cost-effective and good for patient outcomes for every single size and type of physician practice, we would all be using them without any government carrot-and-stick incentives. By throwing money at or taking away money from the market, they skew, or more accurately, distort, the market in perverse ways.

When the door closes in the exam room, healthcare becomes a cottage industry of one-off products. No two patients are alike and no universal health plan payment, EHR, medication or intervention will work for everyone. Yet government laws and regulations try to force this industry's pegs—patients with their infinite variability of illnesses—into a common size and shape hole.

Regarding “Reform Update: UnitedHealth's Optum Labs adds universities, insurer and Merck”, the public has never agreed or given their consent to the use of their personal health data by “research corporations” such as Optum.

The Optum business model, (i.e., buying, selling and trading the nation's health data), is frankly an unfair and deceptive trade practice. Patients don't know about Optum; the company has no direct relationship with patients; and patients are given no choice about whether their data can be used by secondary and tertiary “research corporations” like Optum.

Loopholes in the Health Insurance Portability and Accountability Act appear to grant unfettered access to health data without consent for research or public health uses, but government and industry are ignoring the fact that HIPAA is the “floor” for health data privacy protections, not the “ceiling.”

This kind of business enterprise is patently unfair. According to the original 2001 HIPAA privacy rule, patients were supposed to easily be able to get electronic copies of their records. It's now 13 years later and most patients still can't get access to their own health data—yet Optum and other companies with no direct connection to or relationship with patients data-mine and use their data without their knowledge or consent.

Alan Westin did a very detailed study about patients' attitudes toward open access to personal health data in research for the Institute of Medicine.

Only 1% of the public would approve of open access to their health data for research. If the data were de-identified and there was institutional review board approval, still only 19% of the public would agree to research access to their health data without consent.

The problem is, when patients know that electronic systems cannot be trusted, they act in ways that endanger their health and lives. Nearly 38 million people a year hide information to try and protect their privacy. Some 5 million to 6 million people a year delay or avoid treatment for cancer, depression and STDs for the same reason: to try to keep sensitive health information private.

Would we tolerate a paper medical- record system that harmed 40 million to 50 million people a year or drove then away from treatment?