Today’s Top Story
FDA leaders call for development of robust national evaluation system for medical devices.
In a letter published online in The Journal of the American Medical Association, Robert M. Califf, MD, commissioner of the U.S. Food and Drug Administration (FDA) and Jeffrey Shuren, MD, JD,director of the FDA Center for Devices and Radiological Health argue in favor of a more robust national evaluation system for medical devices. The writers note that in 2012, FDA began the process of establishing a National Evaluation System for Health Technology (NEST) to “quickly identify problematic devices, accurately and transparently characterize and disseminate information about device performance in clinical practice, and efficiently generate data to support premarket clearance or approval of new devices and new uses of currently marketed devices.” Further, some experts have recommended the development of a federated virtual system for evidence generation through strategic alliances among data sources such as registries, electronic health records, payer claims, and other sources. “A national evaluation system that engages all stakeholders could enable the FDA to focus efforts on facilitating the development and interpretation of more informative data essential for policy making and clinical decisions for individuals and populations,” the writers state. Read the letter…
Other News
Study: BMP may not increase cancer risk for lumbar arthrodesis patients.
Findings from a study published in the July 6 issue of The Journal of Bone & Joint Surgery suggest that use of recombinant bone morphogenetic protein (BMP) may not be associated with increased risk of cancer or mortality for older adults who undergo lumbar arthrodesis. The authors conducted a case-cohort study of 7,278 patients aged 65 years or older who had undergone a lumbar arthrodesis between 2004 and 2011. They found that treatment with BMP was not associated with overall cancer risk in univariate analyses or after adjustment for demographic characteristics, comorbidities, hospital size, history of cancer, and calendar year. In addition, the authors note that individual cancer types were also not significantly elevated in BMP users compared with nonusers, nor was BMP use associated with a new cancer in people who had cancer prior to undergoing lumbar arthrodesis or with mortality after a cancer diagnosis. Read the abstract…
Study: What change in score defines a clinically important change after shoulder arthroplasty?
A study published online in the journal Clinical Orthopaedics and Related Research attempts to quantify clinically important changes in American Shoulder and Elbow Surgeons (ASES) scores for patients who undergo shoulder arthroplasty. The research team reviewed data from a longitudinally maintained institutional shoulder arthroplasty registry on 490 primary shoulder arthroplasty patients with minimum 2-year follow-up. They found no differences in minimal clinically important difference (MCID) of the ASES score between anatomic and reverse shoulder arthroplasty or substantial clinical benefit (SCB) across four different anchors measuring satisfaction with work, activities, overall, and activity from the SF-36. “Patients with glenohumeral arthritis or rotator cuff tear arthropathy who undergo primary conventional total or reverse shoulder arthroplasty and have at least a nine-point improvement in their ASES score experience a clinically important change,” the research team writes, “whereas those who have at least a 23-point improvement in their ASES score experience a substantial clinical benefit.” Read the abstract…
Hospital executives argue for repeal or revamp of Stark Law.
Modern Healthcare reports that, in testimony before the Senate Finance Committee, executives from several large health systems argued for repeal or revamp of the Stark Law, stating that the law’s wording makes it difficult for physicians to enter innovative payment arrangements, consistent with new requirements under MACRA (Medicare Access and CHIP Reauthorization Act). The Stark Law generally prohibits physicians from referring Medicare patients to hospitals, labs, and colleagues with whom they have financial relationships. Read more…
Review the hearing testimony…
Study: TBI with loss of consciousness associated with later Parkinson symptoms and Lewy body accumulation, but not Alzheimer disease.
Data from a study published online in the journal JAMA Neurology suggest that traumatic brain injury (TBI) with loss of consciousness (LOC) may be associated with increased risk of Lewy body accumulation, progression of parkinsonism, and Parkinson disease, but not dementia, Alzheimer disease, neuritic plaques, or neurofibrillary tangles. The authors conducted a meta-analysis of three prospective cohort studies covering 7,130 participants, 865 of whom reported a history of TBI with LOC. They found no association between TBI with LOC and incident dementia or Alzheimer disease. However, they noted an association between TBI with LOC and incident Parkinson disease in one study and progression of parkinsonian signs in the two other studies. In addition, traumatic brain injury with LOC was associated with Lewy bodies and microinfarcts. Read more…(registration may be required)
Read the abstract…
Act now to nominate future AAOS leadership!
The 2017 Nominating Committee is actively soliciting your suggestions for individuals to serve in the following positions:
- Second Vice President
- Member-at-Large [No Age Designation]
- Member-at-Large [Under Age 45] (younger than age 45 on March 16, 2017)
- National Membership Committee Member
Nominations close Friday, Aug. 12, 2016. Nominations may be submitted by mail to Joshua J. Jacobs, MD, chair, 2017 Nominating Committee, c/o AAOS Office of General Counsel, 9400 West Higgins Road, Rosemont, Ill. 60018, or (preferred) electronically. Descriptions of the responsibilities, desired experience, and time commitments associated with the positions are available online. Learn more about the positions and access the nomination form…
Last call: OLC Board of Directors.
July 15 is the last day to submit your application for a position on the Orthopaedic Learning Center (OLC) Board of Directors. Members of this board provide governance for strategic planning and oversight for the OLC. Applicants for this position must be active fellows with experience conducting surgical skills courses at the OLC. Learn more and submit your application…(member login required)
