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Rockville, MD, United States

Ratner J.,600 Research Blvd
The American journal of managed care | Year: 2013

Randomized controlled trials (RCTs) reflect priorities established by regulators. Recently, pragmatic clinical trials (PCTs) have begun to attract interest. Unlike RCTs, PCTs aim to better inform post-regulatory decision making by using head-to-head comparisons of alternative treatments, diverse patient populations, and outcomes meaningful to patients, prescribers, and payers. To describe how U.S. insurers and public payers perceive the value of PCTs for assessment of new prescription drugs. Criterion-based sample of U.S. insurers and public payers. We gathered qualitative evidence from intensive interviews with formulary decision makers at 15 payers, representing 10 major types of U.S. payers. Prior literature and exploratory interviews informed our question selection. Payers viewed PCTs favorably despite wariness of drug company-sponsored trials. Payers would accept results from PCTs as part of payers' synthesis of multiple sources of evidence. Payers were enthusiastic about 2 PCT features-a diverse population (compared with the more homogeneous populations typical of RCTs) and an active comparator drug (not placebo). Payers did not anticipate that PCTs would displace their own analyses of internal data. Pharmaceutical companies' financial interest in obtaining trial results that favor their own drugs reduces PCTs' perceived value and dampens their appeal to payers; nonetheless, payers would seek PCT results and review them carefully, as they do other evidence. Recommendations to trial designers based on payers' views include tailoring different types of PCTs to different disease conditions, building in head-to-head comparisons in phase IIIb PCTs, and designing phase IV PCTs to include broader populations.

Johnson K.,600 Research Blvd | Brown M.E.,NASA
Applied Geography | Year: 2014

Much of the population in the developing world resides in rural areas, is dependent on local agriculture for survival, and thus directly subject to increasingly volatile and variable climatic patterns. Poverty limits options for adaptation to unpredictable weather and resultant food insecurity; these concerns are particularly salient in an era of climate change, which threatens to roll back years of development gains. Examining the association between the growing environment and child survival and nutrition is important in this context. Using NASA's satellite remote sensing data with Demographic and Health Surveys (DHS) data from four West African countries (Mali, Burkina Faso, Guinea and Benin), we assess the association between a climate-related environmental variable (vegetation index - NDVI) and child survival and nutrition. NDVI had a positive association with child survival and nutrition in countries with a wide distribution of NDVI values. NDVI was more likely to be positively associated with wasting rather than stunting. We find that environmental factors can be important for child survival and nutrition outcomes in specific contexts. Additional research is needed to further explore the ways NDVI can be used to inform our understanding of the environment's impact on child survival and nutrition. © 2014.

Karl A.T.,Arizona State University | Yang Y.,Arizona State University | Lohr S.L.,600 Research Blvd
Computational Statistics and Data Analysis | Year: 2013

The generalized persistence (GP) model, developed in the context of estimating "value added" by individual teachers to their students' current and future test scores, is one of the most flexible value-added models in the literature. Although developed in the educational setting, the GP model can potentially be applied to any structure where each sequential response of a lower-level unit may be associated with a different higher-level unit, and the effects of the higher-level units may persist over time. The flexibility of the GP model, however, and its multiple membership random effects structure lead to computational challenges that have limited the model's availability. We develop an EM algorithm to compute maximum likelihood estimates efficiently for the GP model, making use of the sparse structure of the random effects and error covariance matrices. The algorithm is implemented in the package GPvam in R statistical software. We give examples of the computations and illustrate the gains in computational efficiency achieved by our estimation procedure. © 2012 Elsevier B.V. All rights reserved.

Mariotto A.B.,U.S. National Cancer Institute | Wang Z.,Management Information Services Inc. | Klabunde C.N.,U.S. National Cancer Institute | Cho H.,U.S. National Cancer Institute | And 3 more authors.
Journal of Clinical Epidemiology | Year: 2013

Objectives To provide cancer patients and clinicians with more accurate estimates of a patient's life expectancy with respect to noncancer mortality, we estimated comorbidity-adjusted life tables and health-adjusted age. Study Design and Setting Using data from the Surveillance Epidemiology and End Results-Medicare database, we estimated comorbidity scores that reflect the health status of people who are 66 years of age and older in the year before cancer diagnosis. Noncancer survival by comorbidity score was estimated for each age, race, and sex. Health-adjusted age was estimated by systematically comparing the noncancer survival models with US life tables. Results Comorbidity, cancer status, sex, and race are all important predictors of noncancer survival; however, their relative impact on noncancer survival decreases as age increases. Survival models by comorbidity better predicted noncancer survival than the US life tables. The health-adjusted age and national life tables can be consulted to provide an approximate estimate of a person's life expectancy, for example, the health-adjusted age of a black man aged 75 years with no comorbidities is 67 years, giving him a life expectancy of 13 years. Conclusion The health-adjusted age and the life tables adjusted by age, race, sex, and comorbidity can provide important information to facilitate decision making about treatment for cancer and other conditions. © 2013 Elsevier Inc. All rights reserved.

Banerjee S.K.,Ipas India | Andersen K.L.,University of North Carolina at Chapel Hill | Buchanan R.M.,600 Research Blvd | Warvadekar J.,Ipas India
BMC Public Health | Year: 2012

Background: Unsafe abortion in India leads to significant morbidity and mortality. Abortion has been legal in India since 1971, and the availability of safe abortion services has increased. However, service availability has not led to a significant reduction in unsafe abortion. This study aimed to understand the gap between safe abortion availability and use of services in Bihar and Jharkhand, India by examining accessibility from the perspective of rural, Indian women. Methods. Two-stage stratified random sampling was used to identify and enroll 1411 married women of reproductive age in four rural districts in Bihar and Jharkhand, India. Data were collected on women's socio-demographic characteristics; exposure to mass media and other information sources; and abortion-related knowledge, perceptions and practices. Multiple linear regression models were used to explore the association between knowledge and perceptions about abortion. Results: Most women were poor, had never attended school, and had limited exposure to mass media. Instead, they relied on community health workers, family and friends for health information. Women who had knowledge about abortion, such as knowing an abortion method, were more likely to perceive that services are available (β = 0.079; p < 0.05) and have positive attitudes toward abortion (β = 0.070; p < 0.05). In addition, women who reported exposure to abortion messages were more likely to have favorable attitudes toward abortion (β = 0.182; p < 0.05). Conclusions: Behavior change communication (BCC) interventions, which address negative perceptions by improving community knowledge about abortion and support local availability of safe abortion services, are needed to increase enabling resources for women and improve potential access to services. Implementing BCC interventions is challenging in settings such as Bihar and Jharkhand where women may be difficult to reach directly, but interventions can target individuals in the community to transfer information to the women who need this information most. Interpersonal approaches that engage community leaders and influencers may also counteract negative social norms regarding abortion and associated stigma. Collaborative actions of government, NGOs and private partners should capitalize on this potential power of communities to reduce the impact of unsafe abortion on rural women. © 2012 Banerjee et al; licensee BioMed Central Ltd.

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