Today’s Top Story
CMS issues proposed rule to reduce mandatory participation in CJR; eliminate SHFFT.
The U.S. Centers for Medicare & Medicaid Services (CMS) has issued a proposed rule to reduce the number of mandatory geographic areas participating in the Comprehensive Care for Joint Replacement (CJR) model from 67 to 34, with CJR participants in the 33 remaining areas allowed to participate on a voluntary basis. The agency also proposes to make CJR participation voluntary for all low-volume and rural hospitals in all CJR geographic areas. Among other things, the rule further proposes to cancel Episode Payment Models (EPMs), including the Surgical Hip and Femur Fracture Treatment (SHFFT) Model, which were scheduled to begin Jan. 1, 2018. CMS states that eliminating such programs will offer the agency greater flexibility to design and test innovations to improve quality and care coordination across the in-patient and post-acute-care spectrum.
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Read the rule…
     In response, the American Association of Orthopaedic Surgeons (AAOS) issued a statement commending CMS for addressing the organization’s concerns by proposing to reduce the geographic area for CJR while retaining a voluntary option. AAOS plans to submit comments on the proposed rule prior to the Oct. 16 due date.
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Other News

Study: How do outcomes compare for various approaches to treatment for shoulder septic arthritis?
A study published in the August issue of the Journal of the AAOS compares outcomes among patients with shoulder septic arthritis who were treated with arthrocentesis, open irrigation and débridement, or arthroscopic irrigation and débridement. The authors reviewed data on 7,145 patients with native shoulder septic arthritis from the Nationwide Inpatient Sample database. Compared to patients who underwent surgical treatment, they found that patients treated nonsurgically had more medical comorbidities and complications, experienced longer length of stay, and were less likely to be discharged to home. Compared to patients treated with open surgery, patients who were treated arthroscopically had higher incidences of perioperative septicemia and urinary tract infection; similar average length of stay, hospital charges, and blood transfusion rates; and a lower incidence of osteomyelitis. Among patients with septicemia, the authors found that Staphylococcus aureus was the most frequently cultured causative organism.
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Study: Little evidence to support use of gabapentinoids for CLBP.
Findings from a study published online in the journal PLoS Medicine suggest there is little evidence to support the use of gabapentinoids for the treatment of chronic low back pain (CLBP). The researchers conducted a systematic review and meta-analysis of eight randomized control trials that reported use of gabapentinoids (gabapentin and pregabalin) for the treatment of CLBP of >3 months duration among adult patients. They found that in the three studies that compared gabapentin against placebo (n = 185), use of gabapentin resulted in minimal improvement of pain. The results of three studies that compared the use of pregabalin with other analgesics revealed that other analgesics provided greater improvement in pain. The researchers did not pool studies that examined pregabalin as an adjuvant, but note that the largest study showed no benefit of adding pregabalin to tapentadol. In addition, they found that use of gabapentin increased the likelihood of dizziness, fatigue, difficulties with mentation, and visual disturbances compared with placebo, although GRADE evidence quality was found to be very low for dizziness and fatigue, low for difficulties with mentation, and moderate for visual disturbances. The researchers identify a need for large high-quality trials to more definitively inform this issue.
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Study: Electrotherapy and acupuncture linked to reductions and delay in opioid consumption following TKA.
A study published online in the journal JAMA Surgery suggests that use of electrotherapy and acupuncture after total knee arthroplasty (TKA) may be associated with reduced and delayed opioid consumption. The research team conducted a meta-analysis of 39 randomized clinical trials covering 2,391 patients who were treated with nonpharmacological interventions for postoperative pain management following TKA. They found that the most common interventions included continuous passive motion, preoperative exercise, cryotherapy, electrotherapy, and acupuncture. Of those, the research team notes that moderate-certainty evidence demonstrated that electrotherapy was linked to reduced use of opioids, while acupuncture was associated with delayed opioid use. Additionally, the research team states that low-certainty evidence linked acupuncture to reduced pain.
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Study: Serum K-Postn levels may help predict incident fractures for postmenopausal women.
According to a study conducted in Switzerland and published online in the Journal of Bone and Mineral Research, serum levels of cathepsin K digestion (K-Postn) may help predict incident fractures among postmenopausal women. The authors conducted a prospective study of 695 women (mean age 65.0 years) who were evaluated for low-trauma fracture over a mean 4.7-year term and who were evaluated at baseline for serum periostin, K-Postn, and bone turnover markers (BTMs); distal radius and tibia microstructure using high resolution peripheral quantitative computed tomography; hip and lumbar spine areal bone mineral density (BMD) using dual-energy X-ray absorptiometry; and fracture probability using the Fracture Risk Assessment Tool (FRAX). They found that circulating K-Postn was associated with incident fractures independent of BMD, BTMs, and FRAX.
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Study data suggest concerns with FDA approval process.
Two studies published in the Aug. 15 issue of The Journal of the American Medical Association suggest that many products may lack solid evidence of efficacy at the time of U.S. Food and Drug Administration (FDA) approval. In the first study, researchers reviewed the methodological quality of 83 studies supporting the approval of 78 panel-track medical device supplements. They found that 71 supplements (91 percent) were supported by a single study. Of the 83 studies, 37 (45 percent) were randomized clinical trials, 25 (30 percent) were blinded, and median follow-up duration was 180 days. Across all studies, the researchers noted a total of 150 primary end points, 121 of which (81 percent) were surrogate, and only 57 (38 percent) of which were compared with controls.
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Note: During the course of the above study, the FDA guidance outlining requirements for premarket approval supplements was modified twice: in 2007 and again in 2008.
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     In the second study, the research team reviewed publicly available FDA documents on accelerated approval of 22 drugs for 24 indications, covering 30 preapproval studies. The median number of participants enrolled in the preapproval studies was 132, and eight studies (27 percent) included fewer than 100 participants. At minimum 3-year follow-up, the research team found that only 19 of 38 (50 percent) of required confirmatory studies had been completed. Overall, post-approval requirements were completed and demonstrated efficacy in 10 of 24 indications (42 percent) on the basis of trials that evaluated surrogate measures. Among the 14 of 24 indications (58 percent) that had not yet completed all requirements, at least one confirmatory study failed to demonstrate clinical benefit in two indications, while clinical benefit had not yet been confirmed across eight indications that had been initially approved 5 or more years prior.
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Call for volunteers: PCPI Foundation board of directors.
AAOS seeks to nominate members to the PCPI® Foundation board of directors. PCPI is a membership organization focused on improving patient health and safety through the advancement of measurement science, quality improvement, and clinical registries. The board is responsible for strategic planning and monitoring, priority setting, financial stewardship, approval of dues, establishing committee structure, approving position statements, providing oversight of programs and committees, and selecting officers. Applicants for this position must be active fellows, candidate members, candidate members osteopathic, candidate member applicants for fellowship, or candidate member applicants for fellowship osteopathic. In addition, all applicants must provide the following: an online AAOS CAP application, a current curriculum vitae, a signed PCPI nomination form, and a signed PCPI conflict of interest form. All supporting materials should be sent to Kyle Trivedi by Aug. 27, 2017, at 11:59 p.m. CT, at: trivedi@aaos.org.
Learn more and submit your application…(member login required)
Learn more and obtain the PCPI forms…