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Muri, Switzerland

Sugar A.,Coordinating Center
JAMA Ophthalmology | Year: 2015

IMPORTANCE: The Cornea Donor Study (CDS) showed that donor age is not a factor in survival of most penetrating keratoplasties for endothelial disease. Secondary analyses confirm the importance of surgical indication and presence of glaucoma in outcomes at 10 years. OBJECTIVE: To assess the relationship between donor and recipient factors and corneal graft survival in the CDS. DESIGN, SETTING, AND PARTICIPANTS: Multicenter prospective, double-masked, controlled clinical trial conducted at 80 clinical sites. One hundred five surgeons enrolled 1090 participants undergoing corneal transplant for a moderate-risk condition, principally Fuchs dystrophy or pseudophakic or aphakic corneal edema (PACE). Forty-three eye banks provided corneas. INTERVENTIONS: Corneas from donors younger than 66 years and donors 66 years or older were assigned, masked to donor age. Surgery and postoperative care were performed according to the surgeons' usual routines. Participants were followed up for as long as 12 years. MAIN OUTCOMES AND MEASURES: Graft failure, defined as a regrafting procedure or a cloudy cornea for 3 consecutive months. RESULTS: The 10-year cumulative probability of graft failure was higher in participants with PACE than in those with Fuchs dystrophy (37%vs 20%; hazard ratio [HR], 2.1 [99%CI, 1.4-3.0]; P < .001) and in participants with a history of glaucoma before penetrating keratoplasty, particularly with prior glaucoma surgery (58%with prior glaucoma surgery and use of medications to lower intraocular pressure at the time of surgery vs 22%with no history of glaucoma surgery or medication use; HR, 4.1 [99% CI, 2.2-7.5]; P < .001). We found trends toward increased graft failure in recipients who were 70 years or older compared with those younger than 60 years (29% vs 19%; HR, 1.2 [99% CI, 0.7-2.1]; P = .04) or were African American (HR, 1.5; P = .11) or who had a history of smoking (35%vs 24%; HR, 1.6 [99%CI, 0.9-2.8]; P = .02). Lower endothelial cell density (ECD) and higher corneal thickness (CT) at 6 months (6%vs 41% for ECD ≥2700 vs <1700 cells/mm2 [P < .001]; 14%vs 36%for CT <500 vs ≥600μm [P = .001]), 1 year (4%vs 39% for ECD ≥2700 vs <1700 cells/mm2 [P < .001]; 18%vs 28%for CT <500 vs ≥600μm [P = .04]), and 5 years (2%vs 29% for ECD ≥1500 vs <500 cells/mm2 [P < .001]; 7%vs 34%for CT <550 vs ≥650 μm [P < .001]) were associated with subsequent graft failure. CONCLUSIONS AND RELEVANCE: Most penetrating corneal grafts for Fuchs dystrophy or PACE remain clear at 10 years. The risk for failure is greater for graft recipients with PACE and those with a history of glaucoma. Measurements of ECD and CT during the course of postkeratoplasty follow-up are associated with a risk for failure. However, even with very low ECD and high CT at 5 years, most corneas remain clear at 10 years. Copyright 2015 American Medical Association. All rights reserved. Source


Dennis M.L.,Coordinating Center | Clark H.W.,Center for Substance Abuse Treatment | Huang L.N.,Office of Behavioral Health Equity
Advances in School Mental Health Promotion | Year: 2014

In this paper, we explore the unmet need for substance use disorder (SUD) treatment among youth, its consequences, and the opportunity to address this gap due to the expansion of behavioral health services to school-based settings under the Parity and Affordable Care Acts. We discuss the importance of using evidence-based approaches to assessment and treatment to ensure effectiveness and cost-effectiveness and show how the severity of SUD is related to a wide range of school, substance, mental, health, and health care utilization problems. Next, we introduce the other three articles in the special issue that further demonstrate the feasibility and impact of using these evidence-based practices in school-based settings, the challenges of identifying and interviewing with youth, and the need for a full continuum of interventions. In each of these areas we try to draw out the policy implication of these trends and papers. Source


Schousboe J.T.,Park Nicollet Institute | Kerlikowske K.,Veterans Affairs Medical Center | Loh A.,California Pacific Medical Center Research Institute | Cummings S.R.,Coordinating Center
Annals of Internal Medicine | Year: 2011

Background: Current guidelines recommend mammography every 1 or 2 years starting at age 40 or 50 years, regardless of individual risk for breast cancer. Objective: To estimate the cost-effectiveness of mammography by age, breast density, history of breast biopsy, family history of breast cancer, and screening interval. Design: Markov microsimulation model. Data Sources: Surveillance, Epidemiology, and End Results program, Breast Cancer Surveillance Consortium, and the medical literature. Target Population: U.S. women aged 40 to 49, 50 to 59, 60 to 69, and 70 to 79 years with initial mammography at age 40 years and breast density of Breast Imaging Reporting and Data System (BI-RADS) categories 1 to 4. Time Horizon: Lifetime. Perspective: National health payer. Intervention: Mammography annually, biennially, or every 3 to 4 years or no mammography. Outcome Measures: Costs per quality-adjusted life-year (QALY) gained and number of women screened over 10 years to prevent 1 death from breast cancer. Results of Base-Case Analysis: Biennial mammography cost less than $100 000 per QALY gained for women aged 40 to 79 years with BI-RADS category 3 or 4 breast density or aged 50 to 69 years with category 2 density; women aged 60 to 79 years with category 1 density and either a family history of breast cancer or a previous breast biopsy; and all women aged 40 to 79 years with both a family history of breast cancer and a previous breast biopsy, regardless of breast density. Biennial mammography cost less than $50 000 per QALY gained for women aged 40 to 49 years with category 3 or 4 breast density and either a previous breast biopsy or a family history of breast cancer. Annual mammography was not cost-effective for any group, regardless of age or breast density. Results of Sensitivity Analysis: Mammography is expensive if the disutility of false-positive mammography results and the costs of detecting nonprogressive and nonlethal invasive cancer are considered. Limitation: Results are not applicable to carriers of BRCA1 or BRCA2 mutations. Conclusion: Mammography screening should be personalized on the basis of a woman's age, breast density, history of breast biopsy, family history of breast cancer, and beliefs about the potential benefit and harms of screening. Primary Funding Source: Eli Lilly, Da Costa Family Foundation for Research in Breast Cancer Prevention of the California Pacific Medical Center, and Breast Cancer Surveillance Consortium. © 2011 American College of Physicians. Source


Derbew M.,Addis Ababa Institute of Technology | Animut N.,Addis Ababa Institute of Technology | Talib Z.M.,George Washington University | Mehtsun S.,Coordinating Center | Hamburger E.K.,George Washington University
Academic Medicine | Year: 2014

In 2003, Ethiopia declared it would pursue the goal of universal primary health coverage. In response to the critical shortage of human resources for health care, the government decided to rapidly increase the training of health workers to provide basic services, including health education, disease prevention, and family health services primarily to rural areas. This approach, which became known as the "flooding strategy," was extended in 2005 to include medical doctors. Between 2003 and 2009, the number of universities and health science colleges grew from 5 to 23, and the original 5 medical schools were given a mandate to increase their annual enrollment by three to four times. This article describes how the "flooding strategy" strained and threatened the quality of the Ethiopian medical education system and how Addis Ababa University responded by leveraging a timely grant through the Medical Education Partnership Initiative (MEPI) to support the establishment of a consortium of four Ethiopian medical schools (MEPI-E). The consortium goals are to address the new demands by (1) maintaining and improving the quality of education through innovation and efficient use of resources, (2) developing and implementing new strategies to build human capacity and promote faculty retention, and (3) increasing locally relevant research and bioethics capacity. Implementation of program began in May 2011. Although it is still under way, MEPI-E has already catalyzed the development of a national network of medical schools, enabling unprecedented collaboration to respond to the increased demands on the Ethiopian medical education system. Source


Bernhard J.,Coordinating Center
Oncology research and treatment | Year: 2014

Clinical benefit response (CBR), based on changes in pain, Karnofsky performance status, and weight, is an established palliative endpoint in trials for advanced gastrointestinal cancer. We investigated whether CBR is associated with survival, and whether CBR reflects a wide-enough range of domains to adequately capture patients' perception. CBR was prospectively evaluated in an international phase III chemotherapy trial in patients with advanced pancreatic cancer (n = 311) in parallel with patient-reported outcomes (PROs). The median time to treatment failure was 3.4 months (range: 0-6). The majority of the CBRs (n = 39) were noted in patients who received chemotherapy for at least 5 months. Patients with CBR (n = 62) had longer survival than non-responders (n = 182) (hazard ratio = 0.69; 95% confidence interval: 0.51-0.94; p = 0.013). CBR was predicted with a sensitivity and specificity of 77-80% by various combinations of 3 mainly physical PROs. A comparison between the duration of CBR (n = 62, median = 8 months, range = 4-31) and clinically meaningful improvements in the PROs (n = 100-116; medians = 9-11 months, range = 4-24) showed similar intervals. CBR is associated with survival and mainly reflects physical domains. Within phase III chemotherapy trials for advanced gastrointestinal cancer, CBR can be replaced by a PRO evaluation, without losing substantial information but gaining complementary information. © 2014 S. Karger GmbH, Freiburg. Source

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