Stewart D.E.,United Network for Organ Sharing |
Kucheryavaya A.Y.,United Network for Organ Sharing |
Klassen D.K.,Office of the Chief Medical Officer |
Turgeon N.A.,Emory University |
And 2 more authors.
American Journal of Transplantation | Year: 2016
After over a decade of discussion, analysis, and consensus-building, a new kidney allocation system (KAS) was implemented on December 4, 2014. Key goals included improving longevity matching between donor kidneys and recipients and broadening access for historically disadvantaged subpopulations, in particular highly sensitized patients and those with an extended duration on dialysis but delayed referral for transplantation. To evaluate the early impact of KAS, we compared Organ Procurement and Transplantation Network data 1 year before versus after implementation. The distribution of transplants across many recipient characteristics has changed markedly and suggests that in many ways the new policy is achieving its goals. Transplants in which the donor and recipient age differed by more than 30 years declined by 23%. Initial, sharp increases in transplants were observed for Calculated Panel-Reactive Antibody 99–100% recipients and recipients with at least 10 years on dialysis, with a subsequent tapering of transplants to these groups suggesting bolus effects. Although KAS has arguably increased fairness in allocation, the potential costs of broadening access must be considered. Kidneys are more often being shipped over long distances, leading to increased cold ischemic times. Delayed graft function rates have increased, but 6-month graft survival rates have not changed significantly. © Copyright 2016 The American Society of Transplantation and the American Society of Transplant Surgeons
McNeely T.B.,Merck And Co. |
McNeely T.B.,Photosonix Medical |
Shah N.A.,Merck And Co. |
Fridman A.,Merck And Co. |
And 5 more authors.
Human Vaccines and Immunotherapeutics | Year: 2014
In a blinded randomized trial, preoperative receipt of the Merck V710 Staphylococcus aureus vaccine was associated with a higher mortality rate than placebo in patients who later developed postoperative S. aureus infections. Of the tested patients, all 12 V710 recipients (but only 1 of 13 placebo recipients) with undetectable serum IL2 levels prior to vaccination and surgery died after postoperative S. aureus infection. The coincidence of 3 factors (low prevaccination IL- 2 levels, receipt of V710, and postoperative S. aureus infection) appeared to substantially increase mortality in our study population after major cardiothoracic surgery. Furthermore, 9 of the 10 V710 recipients with undetectable preoperative IL17a levels and postoperative S. aureus infections died. Although the current study is hypothesis-generating and the exact pathophysiology remains speculative, these findings raise concern that immune predispositions may adversely impact the safety and efficacy of staphylococcal vaccines actively under development. The potential benefits of an effective vaccine against S. aureus justify continued but cautious pursuit of this elusive goal. © 2014 Taylor & Francis Group, LLC.
Kissling E.,EpiConcept |
Valenciano M.,EpiConcept |
Larrauri A.,Institute Salud Carlos III |
Oroszi B.,Office of the Chief Medical Officer |
And 19 more authors.
Eurosurveillance | Year: 2013
Within the Influenza Monitoring Vaccine Effectiveness in Europe (I-MOVE) project we conducted a multicentre case-control study in eight European Union (EU) Member States to estimate the 2011/12 influenza vaccine effectiveness against medically attended influenza-like illness (ILI) laboratory-confirmed as influenza A(H3) among the vaccination target groups. Practitioners systematically selected ILI / acute respiratory infection patients to swab within seven days of symptom onset. We restricted the study population to those meeting the EU ILI case definition and compared influenza A(H3) positive to influenza laboratory-negative patients. We used logistic regression with study site as fixed effect and calculated adjusted influenza vaccine effectiveness (IVE), controlling for potential confounders (age group, sex, month of symptom onset, chronic diseases and related hospitalisations, number of practitioner visits in the previous year). Adjusted IVE was 25% (95% confidence intervals (CI): -6 to 47) among all ages (n=1,014), 63% (95% CI: 26 to 82) in adults aged between 15 and 59 years and 15% (95% CI: -33 to 46) among those aged 60 years and above. Adjusted IVE was 38% (95%CI: -8 to 65) in the early influenza season (up to week 6 of 2012) and -1% (95% CI: -60 to 37) in the late phase. The results suggested a low adjusted IVE in 2011/12. The lower IVE in the late season could be due to virus changes through the season or waning immunity. Virological surveillance should be enhanced to quantify change over time and understand its relation with duration of immunological protection. Seasonal influenza vaccines should be improved to achieve acceptable levels of protection.
Cuzick J.,Queen Mary, University of London |
Thorat M.A.,Queen Mary, University of London |
Andriole G.,University of Washington |
Brawley O.W.,Office of the Chief Medical Officer |
And 30 more authors.
The Lancet Oncology | Year: 2014
Prostate cancer is a common malignancy in men and the worldwide burden of this disease is rising. Lifestyle modifications such as smoking cessation, exercise, and weight control offer opportunities to reduce the risk of developing prostate cancer. Early detection of prostate cancer by prostate-specific antigen (PSA) screening is controversial, but changes in the PSA threshold, frequency of screening, and the use of other biomarkers have the potential to minimise the overdiagnosis associated with PSA screening. Several new biomarkers for individuals with raised PSA concentrations or those diagnosed with prostate cancer are likely to identify individuals who can be spared aggressive treatment. Several pharmacological agents such as 5α-reductase inhibitors and aspirin could prevent development of prostate cancer. In this Review, we discuss the present evidence and research questions regarding prevention, early detection of prostate cancer, and management of men either at high risk of prostate cancer or diagnosed with low-grade prostate cancer. © 2014 Elsevier Ltd.
Gregory R.S.,Rx Gregory Consulting LLC |
Handelsman Y.,Metabolic Institute of America |
Handelsman Y.,Universal City |
Pezalla E.J.,Office of the Chief Medical Officer |
American Journal of Managed Care | Year: 2014
The prevalence of obesity, defined as a body mass index of 30 or more, has reached epidemic proportions in the United States. Obesity is associated with an increased risk of multiple conditions, including type 2 diabetes mellitus, cardiovascular disease, arthritis, and sleep apnea. To discuss issues related to obesity in the workplace, healthcare, and managed care settings, stakeholders from these areas participated in a roundtable discussion on several topics, including the management of obesity, managed care coverage policies for obesity treatments, and potential strategies for improving patient outcomes. Participants agreed that obesity is a challenging condition to treat. Lifestyle modification, one of the most commonly recommended treatment modalities, is often inadequate on its own, as patients are unable to maintain weight loss over time. Although lifestyle modification remains important, additional tools are needed. In patients who undergo bariatric surgery, lifestyle modification is also necessary for long-term weight maintenance; however, surgery is not appropriate for all patients. Pharmacologic treatment may also be considered, but cost and managed care coverage policies have the potential to limit patient access to this treatment modality. Increased awareness and additional efforts on the part of all stakeholders are needed to improve outcomes for patients affected by obesity.
Hughes S.,Clinical Statistics |
Wells K.,Statistical Governance |
McSorley P.,Moore Research |
Freeman A.,Office of the Chief Medical Officer
Pharmaceutical Statistics | Year: 2014
In May 2013, GlaxoSmithKline (980 Great West Road, Brentford, Middlesex, TW8 9GS, UK) established a new online system to enable scientific researchers to request access to anonymised patient level clinical trial data. Providing access to individual patient data collected in clinical trials enables conduct of further research that may help advance medical science or improve patient care. In turn, this helps ensure that the data provided by research participants are used to maximum effect in the creation of new knowledge and understanding. However, when providing access to individual patient data, maintaining the privacy and confidentiality of research participants is critical. This article describes the approach we have taken to prepare data for sharing with other researchers in a way that minimises risk with respect to the privacy and confidentiality of research participants, ensures compliance with current data privacy legal requirements and yet retains utility of the anonymised datasets for research purposes. We recognise that there are different possible approaches and that broad consensus is needed. © 2014 John Wiley & Sons, Ltd.
PubMed | Surveillance and Health Services Research, Office of the Chief Medical Officer and Cancer Control Science
Type: Journal Article | Journal: Cancer | Year: 2015
A recent study estimates that 277,000 colorectal cancer (CRC) cases and 203,000 CRC deaths will be averted between 2013 and 2030 if the National Colorectal Cancer Roundtable goal of increasing CRC screening prevalence to 80% by 2018 is reached. However, the number of individuals who need to be screened (NNS) to achieve this goal is unknown. In this communication, the authors estimate the NNS to achieve 80% by 2018 nationwide and by state.The authors estimated the NNS by subtracting adults aged 50 to 75 years who would need to be screened to achieve an 80% CRC screening prevalence from the number who are currently guideline-compliant from population estimates for this age group. The 2013 National Health Interview Survey and the 2012 Behavioral Risk Factor Surveillance System were used to estimate CRC screening prevalence and data from the US Census Bureau were used to estimate population projections. The NNS were age-standardized and sex-standardized.Nationwide, 24.39 million individuals (95% confidence interval, 24.37-24.41 million) aged 50 to 75 years will need to be screened to achieve 80% by 2018. By state, the NNS ranged from 45,400 in Vermont to 2.72 million in California. The majority of individuals who need to be screened are aged 50 to 64 years and the largest subgroup is privately insured.The authors estimated that at least 24.4 million additional individuals in the United States will need to be screened to achieve the National Colorectal Cancer Roundtable goal of increasing CRC screening prevalence to 80% by 2018. To reach this goal, improving facilitators of CRC screening, including physician recommendation and patient awareness, is needed.
PubMed | Office of the Chief Medical Officer and Merck And Co.
Type: Journal Article | Journal: Open forum infectious diseases | Year: 2015
We analyzed the impact of pretreatment variants conferring boceprevir-resistance on sustained virologic response (SVR) rates achieved with boceprevir plus peginterferon-/ribavirin (P/R) for hepatitis C virus (HCV)-genotype-1 infection.NS3-protease-polymorphisms emerging coincident with virologic failure on boceprevir/P/R regimens were identified as resistance-associated variants (RAVs). Baseline samples pooled from 6 phase II or phase III clinical trials were analyzed for RAVs by population sequencing. Interferon (IFN)-responsiveness was predefined as >1 log reduction in HCV-RNA level during the initial 4-week lead-in treatment with P/R before boceprevir was added. The effective boceprevir-concentration inhibiting RAV growth by 50% (EC50) was determined using a replicon assay relative to the wild-type referent.Sequencing was performed in 2241 of 2353 patients (95.2%) treated with boceprevir. At baseline, RAVs were detected in 178 patients (7.9%), including 153 of 1498 genotype-1a infections (10.2%) and 25 of 742 genotype-1b infections (3.4%) (relative risk, 3.03; 95% confidence interval [CI], [2.01, 4.58]). For IFN-responders, SVR24 (SVR assessed 24 weeks after discontinuation of all study medications) rates were 78% and 76% with or without RAVs detected at baseline, respectively. For the 510 poor IFN-responders, SVR24 rates were 8 of 36 subjects (22.2% [11.7%, 38.1%]) when baseline RAVs were detected vs 174 of 474 subjects (36.7% [32.5%, 41.1%]) when baseline RAVs were not detected (relative likelihood of SVR24 [95% CI], 0.61 [0.32, 1.05]). Sustained virologic response was achieved in 7 of 8 (87.5%) IFN-nonresponders with baseline variants exhibiting 2-fold increased EC50 for boceprevir in a replicon assay, whereas only 1 of 15 (7%) IFN-nonresponders with baseline RAVs associated with 3-fold increased EC50 achieved SVR.Baseline protease-variants appear to negatively impact SVR rates for boceprevir/P/R regimens only when associated with decreased boceprevir susceptibility in vitro after a poor IFN-response during the lead-in period.
PubMed | Office of the Chief Medical Officer and Merck And Co.
Type: Journal Article | Journal: Open forum infectious diseases | Year: 2015
The immunogenicity results from 3 phase I trials of the Merck DNA human immunodeficiency virus (HIV) vaccine have previously been reported. Because preventive DNA vaccine strategies continue to be leveraged for diverse infections, the safety and tolerability results from these studies can inform the field moving forward, particularly regarding adverse reactions and adjuvants. No serious vaccine-related adverse events were reported during the 3-dose priming phase. Pain at the injection site was more common with adjuvanted formulations than with the phosphate-buffered saline diluent alone. Febrile reactions were usually low grade. Although the AlPO4 or CRL1005 adjuvants used in these studies did not significantly enhance the immunogenicity of the DNA vaccine, adverse events were numerically more common with adjuvanted formulations than without adjuvants.
News Article | February 28, 2017
DENVER, Feb. 28, 2017 /PRNewswire/ -- DaVita Kidney Care, a division of DaVita Inc. (NYSE: DVA) and a leading provider of kidney care services in the United States, welcomes Dr. Adam Weinstein as vice president of medical affairs, within DaVita's Office of the Chief Medical Officer. "D...