FDA issues guidance on use of EHRs in clinical trials
The Food and Drug Administration (FDA) issued recommendations on the use of electronic health record (EHR) data in FDA-regulated clinical trials. According to the guidance, EHRs may provide more data during and after the study, and use of Office of the National Coordinator for Health Information Technology-certified software to ensure EHR reliability is therefore recommended. The guidance says researchers should consider whether the use of EHRs has the potential to expose blinded trials, and if so, they should not be used.
An article in Healthcare Finance News reports that Department of Health and Human Services (HHS) Director Alex Azar named Centers for Medicare and Medicaid Innovation Director Adam Boehler senior adviser for value-based transformation and innovation. The initiative seeks to more quickly advance the shift from fee-for-service to value-based care. The article states that, according to Politico, HHS officials have said regulations such as Stark Law and the Health Insurance Portability and Accountability Act are roadblocks to value-based care and noted that providers participating in these payment models will need to be more accountable and generate faster results. AAOS met with Mr. Boehler last week.
HHS has requested permission from the Office of Management and Budget to create a database on patient safety at ambulatory surgery centers (ASCs), Modern Healthcare reports. The request follows a joint investigation by Kaiser Health News and USA Today that raised concerns about the quality of care and safety at these facilities. In 2016, there were 5,532 Medicare-certified centers, which was a 3.5 percent increase from 5,344 in 2011, reflecting an average annual growth rate of 1.3 percent. Approximately 3.4 million Medicare beneficiaries receive care at these centers annually.
Study: Arthroscopic subacromial decompression doesn’t best placebo for shoulder impingement
Arthroscopic subacromial decompression (ASD) was shown to provide no benefit over diagnostic arthroscopy at 24 months in patients with shoulder impingement, according to a study published in The BMJ. Researchers for the Finnish Subacromial Impingement Arthroscopy Controlled Trial (FIMPACT) enrolled 210 patients with symptoms consistent with shoulder impingement, and randomly assigned them to either arthroscopic subacromial decompression ASD, diagnostic arthroscopy (placebo control), or exercise therapy. Primary outcomes measures were shoulder pain at rest and on arm activity at 24 months. In the primary intent-to-treat analysis (ASD compared to diagnostic arthroscopy), the researchers found no clinically relevant between-group differences in the two primary outcomes.
States opposing ACA could be most impacted by its repeal
Kaiser Health News reports that states that oppose the Affordable Care Act (ACA) appear to be the ones that would be most affected if the law is repealed. Nine of the 11 states with individuals 65 years and older with the most preexisting conditions have signed onto a suit against ACA, according to data from the Centers for Disease Control and Prevention and insurance companies. West Virginia has the most adults with preexisting conditions, 36 percent of whom are under 65 years of age. Without ACA protections, a third of these residents would have trouble purchasing insurance through the individual marketplace.
Exposure: Radiation is the ‘invisible enemy’ of female orthopaedic surgeons
Marie Curie, a brilliant physicist, was the first female to win the Nobel prize for her pioneering work on radioactivity. She is a role model for her groundbreaking contributions to science. It’s ironic that the same research that brought her such well-earned recognition eventually led to her demise: aplastic anemia secondary to radiation exposure. Adverse events associated with radiation include deterministic (e.g., hair loss, skin burns, nausea, cataracts) and stochastic (i.e., carcinogenesis, teratogenesis) effects. As orthopaedic surgeons, we also continually expose our bodies to radiation in our quest for success and best outcomes.
AAOS seeks input for distal radius fractures CPG and QM
AAOS and the American Society for Surgery of the Hand request commentary on distal radius fractures for the development of a Clinical Practice Guideline (CPG) and associated quality measures (QM). Suggestions will be collated and presented to the multidisciplinary clinician volunteer work group for consideration. The deadline to submit up to 10 topic suggestions and five quality measures is Aug. 20.