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Montaquila J.M.,600 Research Blvd | Montaquila J.M.,University of Maryland University College | Brick J.M.,600 Research Blvd | Brick J.M.,University of Maryland University College | Curtin L.R.,Centers for Disease Control and Prevention
Statistics in Medicine | Year: 2010

The National Children's Study is a national household probability sample designed to identify 100 000 children at birth and follow the sampled children for 21 years. Data from the study will support examining numerous hypotheses concerning genetic and environmental effects on the health and development of children. The goals of the study present substantial challenges. For example, the need for preconception, prenatal, and postnatal data requires identifying women in the early stages of pregnancy, the collection of many types of data, and the retention of the children over time. In this paper, we give an overview of the sample design used in a pilot study called the Vanguard Study, and highlight the approaches used to address these challenges. We will also describe the rationale for the sampling choices made at each stage, the unique organizational structure of the NCS and issues we expect to face during implementation.

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.

Korelitz J.J.,600 Research Blvd | McNally D.L.,University of Maryland, Baltimore | Masters M.N.,600 Research Blvd | Li S.X.,600 Research Blvd | And 2 more authors.
Thyroid | Year: 2013

Background: Population-based estimates of the prevalence of thyrotoxicosis (TTX), the frequency of antithyroid drug (ATD) use, and risk of adverse events in pregnant women and their infants are lacking. Therefore, our objective was to obtain epidemiologic estimates of these parameters within a large population-based sample of pregnant women with TTX. Methods: A retrospective claims analysis was performed from the MarketScan Commercial Claims and Encounters health insurance database for the period 2005-2009. Women aged 15-44 years, enrolled for at least 2 years, and who had a pregnancy during the study period were included. Diagnosis of TTX was based on International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes using narrow (TTX-1=ICD 242.0) and broad (TTX-2=ICD 242.0 or 242.9) definitions. ATD use was based on prescriptions filled for propylthiouracil (PTU) or methimazole (MMI). Adverse events in mothers and infants were determined from the ICD-9-CM diagnosis codes recorded on submitted claims. Results: The database contained 904,497 eligible women. The average yearly prevalence per 1000 pregnant women was 2.46 for TTX-1 and 5.88 for TTX-2. Thirty-nine percent used ATD at any time during the study period. Compared to women without a TTX diagnosis, there was more than a twofold increase for liver disease among women with TTX (odds ratio [OR]=2.08, p<0.001) and a 13% increased risk for congenital anomalies (OR=1.13, p=0.014), but no association was observed with ATD use. The rates of congenital defects (per 1000 infants) associated with ATD use were 55.6 for MMI, 72.1 for PTU, and 65.8 for untreated women with TTX, compared to 58.8 among women without TTX. Conclusions: There was some indication of an elevated risk of liver disease and congenital anomalies in women with TTX, but the risk did not appear to be related to the ATD use. There seems to be a higher pregnancy termination rate for women with TTX on MMI, which likely reflects elective pregnancy terminations. © Copyright 2013, Mary Ann Liebert, Inc. 2013.

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.

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.

Sorra J.,600 Research Blvd | Khanna K.,600 Research Blvd | Dyer N.,600 Research Blvd | Mardon R.,600 Research Blvd | Famolaro T.,600 Research Blvd
Journal of Patient Safety | Year: 2012

OBJECTIVES: The purpose of this study was to examine relationships among 2 Agency for Healthcare Research and Quality measures of hospital patient safety and quality, which reflect different perspectives on hospital performance: the Hospital Survey on Patient Safety Culture (Hospital SOPS)-a hospital employee patient safety culture survey-and the Consumer Assessment of Healthcare Providers and Systems Hospital Survey (CAHPS Hospital Survey)-a survey of the experiences of adult inpatients with hospital care and services. Our hypothesis was that these 2 measures would be positively related. METHODS: We performed multiple regressions to examine the relationships between the Hospital SOPS measures and CAHPS Hospital Survey measures, controlling for hospital bed size and ownership. Analyses were conducted at the hospital level with each survey's measures using data from 73 hospitals that administered both surveys during similar periods. RESULTS: Higher overall Hospital SOPS composite average scores were associated with higher overall CAHPS Hospital Survey composite average scores (r = 0.41, P < 0.01). Twelve of 15 Hospital SOPS measures were positively related to the CAHPS Hospital Survey composite average score after controlling for bed size and ownership, with significant standardized regression coefficients ranging from 0.25 to 0.38. None of the Hospital SOPS measures were significantly correlated with either of the two single-item CAHPS Hospital Survey measures (hospital rating and willingness to recommend). CONCLUSIONS: This study found that hospitals where staff have more positive perceptions of patient safety culture tend to have more positive assessments of care from patients. This finding helps validate both surveys and suggests that improvements in patient safety culture may lead to improved patient experience with care. Further research is needed to determine the generalizability of these results to larger sets of hospitals, to hospital units, and to other settings of care. Copyright © 2012 by Lippincott Williams & Wilkins.

Rippen H.E.,600 Research Blvd | Pan E.C.,600 Research Blvd | Russell C.,600 Research Blvd | Byrne C.M.,600 Research Blvd | Swift E.K.,600 Research Blvd
International Journal of Medical Informatics | Year: 2013

Purpose: We do not yet know how best to design, implement, and use health information technology (IT). A comprehensive framework that captures knowledge on the implementation, use, and optimization of health IT will help guide more effective approaches in the future. Methods: The authors conducted a targeted review of existing literature on health IT implementation and use, including health IT-related theories and models. By crosswalking elements of current theories and models, the authors identified five major facets of an organizational framework that provides a structure to organize and capture information on the implementation and use of health IT. Results: The authors propose a novel organizational framework for health IT implementation and use with five major facets: technology, use, environment, outcomes, and temporality. Each major facet is described in detail along with associated categories and measures. Conclusion: The proposed framework is an essential first step toward ensuring a more consistent and comprehensive understanding of health IT implementation and use and a more rigorous approach to data collection, measurement development, and theory building. © 2012 Elsevier Ireland Ltd.

Lipman P.D.,600 Research Blvd | Aspy C.B.,The University of Oklahoma Health Sciences Center
Journal of the American Board of Family Medicine | Year: 2016

Background: Four practice-based research networks (PBRNs) participated in a project to increase the diffusion of evidence-based treatment guidelines for chronic kidney disease (CKD). A multicomponent organizational intervention engaged regionally proximal primary care practices in a series of facilitated meetings, referred to as local learning collaboratives (LLCs). Methods: The 2-wave strategy began with 8 practices in each PBRN receiving practice facilitation and subsequently joining an LLC. A sequential mixed-methods design addressed the conduct, content, and fidelity of the intervention; clinicians in 2 PBRNs participated in interviews, and PBRN coordinators reflected on implementation challenges. Results: LLCs were formed in 3 PBRNs, with 121 monthly meetings held across 20 LLCs. Slightly more than half of the participants were clinicians. Qualitative data suggest that clinicians increased the priority for CKD care, improved knowledge and skills, were satisfied with the project, and attempted to improve care. Implementation challenges were encountered and concerns about sustainability expressed. Conclusion: While PBRNs can successfully leverage resources to diffuse treatment guidelines, and LLCs are well-accepted by clinical staff, the formation of LLCs was not feasible for 1 PBRN, and others struggled to meet regularly and have performance data available despite logistic support.

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.

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