Association of the Comprehensive ESRD Care Model with Treatment Adherence.

Background: Poor adherence to scheduled dialysis treatments is common and can cause adverse clinical and economic outcomes. In 2015, the Centers for Medicare and Medicaid Innovation launched the Comprehensive ESRD Care (CEC) Model, a novel modification of the Accountable Care Organization framework. Many model participants reported efforts to increase dialysis adherence and promptly reschedule missed treatments. Methods: With Medicare databases covering 2014-2019, we used difference-in-differences models to compare treatment adherence among patients aligned to 1037 CEC facilities relative to those aligned to matched comparison facilities, while accounting for their differences at baseline. Using dates of service, we identified patients who typically received three weekly treatments and the days when treatments typically occurred. Skipped treatments were defined as days when the patient was not hospitalized but did not receive an expected treatment, and rescheduled treatments as days when a patient who had skipped their previous treatment received an additional treatment before their next expected treatment date. Results: Patients in the CEC Model had higher odds of attending as-scheduled sessions relative to the comparison group, although the effect was only marginally significant (OR, 1.02; 95% CI, 1.00 to 1.04, P=0.08). Effects were stronger among females (OR, 1.03; 95% CI, 1.00 to 1.06, P=0.06) than males (OR, 1.01; 95% CI, 0.98 to 1.04, P=0.49), and among those aged <70 years (OR, 1.02; 95% CI, 1.00 to 1.05, P=0.04) than those aged ≥70 years (OR, 1.00; 95% CI, 0.96 to 1.04, P=0.96). The CEC was associated with higher odds of rescheduled sessions (OR, 1.09; 95% CI, 1.05 to 1.14, P<0.001). Effects were significant for both sexes, but were larger among males (OR, 1.11; 95% CI, 1.05 to 1.18, P<0.001) than females (OR, 1.07; 95% CI, 1.02 to 1.13, P=0.01), and effects were significant among those <70 years (OR, 1.12; 95% CI, 1.07 to 1.17, P<0.001), but not those ≥70 years (OR, 0.99; 95% CI, 0.92 to 1.07, P=0.80). Conclusions: The CEC Model is intended to incentivize strategies to prevent costly interventions. Because poor dialysis adherence may precipitate hospitalizations or other adverse events, many CEC Model participants encouraged adherence and promptly rescheduled missed treatments as strategic priorities. This study suggests these efforts were a success, although the absolute magnitudes of the effects were modest.

Medicare's Specialty-Oriented Accountable Care Organization: First-Year Results For People With End-Stage Renal Disease.

The Comprehensive End-Stage Renal Disease (ESRD) Care (CEC) Model was the first Medicare specialty-oriented accountable care organization (ACO) model. We examined whether this model provided better results for beneficiaries with ESRD than primary care-based ACO models. We found significant decreases in Medicare payments ($126 per beneficiary per month), hospitalizations (5 percent), and likelihood of readmissions (8 percent) among beneficiaries with ESRD during the first year of alignment with the CEC Model and no impacts on these measures among beneficiaries with ESRD who were aligned with primary care-based ACOs, relative to fee-for-service Medicare beneficiaries. Neither the CEC nor primary care-based ACO models significantly reduced the likelihood of catheter use, but fistula use increased for CEC Model beneficiaries to levels just above statistical significance. Other populations with chronic conditions may benefit from the testing of a specialty-oriented ACO model. In addition, primary care-based ACOs may benefit from applying CEC Model strategies to high-need subpopulations. Last, the strategies that enabled ESRD Seamless Care Organizations to achieve reductions in hospitalizations and readmissions even without hospital participation as owners could inform physician-led ACOs' efforts to coordinate with hospitals in their areas.

MOR209/ES414, a Novel Bispecific Antibody Targeting PSMA for the Treatment of Metastatic Castration-Resistant Prostate Cancer.

Treatment of metastatic, castration-resistant prostate cancer (mCRPC) remains a highly unmet medical need and current therapies ultimately result in disease progression. Immunotherapy is a rapidly growing approach for treatment of cancer but has shown limited success to date in the treatment of mCRPC. We have developed a novel humanized bispecific antibody, MOR209/ES414, built on the ADAPTIR (modular protein technology) platform, to redirect T-cell cytotoxicity toward prostate cancer cells by specifically targeting T cells through CD3ε to prostate cancer cells expressing PSMA (prostate-specific membrane antigen). In vitro cross-linking of T cells with PSMA-expressing tumor cells by MOR209/ES414 triggered potent target-dependent tumor lysis and induction of target-dependent T-cell activation and proliferation. This activity occurred at low picomolar concentrations of MOR209/ES414 and was effective at low T-effector to tumor target cell ratios. In addition, cytotoxic activity was equivalent over a wide range of PSMA expression on target cells, suggesting that as few as 3,700 PSMA receptors per cell are sufficient for tumor lysis. In addition to high sensitivity and in vitro activity, MOR209/ES414 induced limited production of cytokines compared with other bispecific antibody formats. Pharmacokinetic analysis of MOR209/ES414 demonstrated a serum elimination half-life in NOD/SCID γ (NSG) mice of 4 days. Administration of MOR209/ES414 in murine xenograft models of human prostate cancer significantly inhibited tumor growth, prolonged survival, and decreased serum prostate-specific antigen levels only in the presence of adoptively transferred human T cells. On the basis of these preclinical findings, MOR209/ES414 warrants further investigation as a potential therapeutic for the treatment of CRPC. Mol Cancer Ther; 15(9); 2155-65. ©2016 AACR.

Relationship between systemic bone mineral density and local bone quality as effectors of dental implant survival.

PURPOSE: This study aimed to assess (1) the relationship of systemic bone mineral density (BMD) and osteoporotic status with the surgeon's subjective assessment of local jawbone quality, and (2) whether the surgeon's subjective assessment of local jawbone quality is a predictor of implant failure. MATERIALS AND METHODS: A retrospective analysis of 2,867 dental implants placed in 645 patients was accomplished. The surgeon's assessment of bone quality at the time of dental implant placement was recorded. Of those, 208 patients with 701 implants had BMD data available within 3 years. Statistical analyses were conducted to determine relationships between BMD, osteoporotic status, and local jawbone quality and to determine the relationship between local jawbone quality and implant survival. RESULTS: There was no association between systemic BMD and the surgeon's assessment of bone quality (p =.52) nor between osteoporotic status and the surgeon's assessment of local jawbone quality (Spearman rank correlation coefficient=0.08). Additional retrospective analysis revealed implants placed in moderate- (hazard ratio=1.67; p=.043) or poor-quality (HR=3.45, p< .001) bone (surgeon's assessment) were significantly more likely to fail than implants placed in good-quality bone. CONCLUSION: Systemic BMD and osteoporotic status are not associated with local jawbone quality. Implants placed in good-quality bone, as assessed subjectively by the surgeon at the time of implant placement, have significantly better survival characteristics than implants placed in moderate-/poor-quality bone.

The use of distraction osteogenesis to treat hemifacial microsomia: a clinical report.

Distraction osteogenesis is a method of forming bone through osteotomy and sequential stretching of the healing callus. This process is accomplished with the aid of a distraction device, which is secured with screws placed directly into bone for a predetermined length of time. This clinical report describes the use of distraction osteogenesis to treat mandibular asymmetry in a patient with Goldenhar's syndrome, a form of hemifacial microsomia. After treatment, the patient had a more rounded facial contour and corrected occlusal plane.