Development times, clinical testing, postmarket follow-up, and safety risks for the new drugs approved by the US food and drug administration: the class of 2008.

Importance: The US Food and Drug Administration (FDA) has advanced multiple proposals to promote biomedical innovation by making new drugs available more quickly but with shorter, smaller, and more selective clinical trials and less rigorous end points.

Objective: To inform the debate about appropriate standards, we studied the development times, clinical testing, postmarket follow-up, and safety risks for the new drugs approved by the FDA in 2008, when most provisions of current law, regulation, and policies were in effect.

Design: Descriptive study of the drugs classified as new molecular entities using preapproval FDA evaluation documents, agency drug information databases, prescribing information, and other primary data sources.

Raising the bar on achieving racial diversity in higher education: the United States Supreme Court's decision in Fisher v University of Texas.

In Fisher v University of Texas, the U.S. Supreme Court revisited the constitutionality of race-conscious admissions practices aimed at fostering student diversity in university programs.

Long-term follow-up of children in the HIVNET 012 perinatal HIV prevention trial: five-year growth and survival.

Objectives: To describe 5-year growth, survival, and long-term safety among children exposed to nevirapine or zidovudine in an African perinatal prevention trial, HIVNET 012.

Methods: All study children who were alive at the age 18 months were eligible for an extended follow-up study. Children whose families consented were enrolled and evaluated every 6 months from 24 to 60 months.

Immunogenicity of ALVAC-HIV vCP1521 in infants of HIV-1-infected women in Uganda (HPTN 027): the first pediatric HIV vaccine trial in Africa.

Objective: Maternal-to-child-transmission of HIV-1 infection remains a significant cause of HIV-1 infection despite successful prevention strategies. Testing protective HIV-1 vaccines remains a critical priority. The immunogenicity of ALVAC-HIV vCP1521 (ALVAC) in infants born to HIV-1-infected women in Uganda was evaluated in the first pediatric HIV-1 vaccine study in Africa.

Exploring the relationship between incarceration and HIV among black men who have sex with men in the United States.

This study examined the predictors of new incarceration and their association with HIV infection among 1278 black men who have sex with men enrolled and followed up in the HIV Prevention Trials Network 061 study. HIV Prevention Trials Network 061 was conducted to determine the feasibility and acceptability of a multicomponent intervention to reduce HIV infection among BMSM in 6 US cities. In this study, multivariable logistic regression models were used to explore the association between incarceration during study follow-up and several demographic, behavioral, and psychosocial variables at baseline found to be significant in bivariate analyses.

Incidence of methicillin-resistant Staphylococcus aureus infection in a children's hospital in the Washington metropolitan area of the United States, 2003 - 2010.

Methicillin-resistant Staphylococcus aureus (MRSA) has emerged as a major public health threat. In this retrospective cohort study, we included patients with laboratory-confirmed MRSA infections treated at Children's National Medical Center in Washington, District of Columbia between July 2003 and December 2010. The secular trends in the incidence rates of skin/soft tissue and invasive MRSA infections were assessed.

The changing physician assistant profession: a gender shift.

The physician assistant (PA) movement originally served as an avenue for male veterans to transition into the civilian workforce. After a half-century of development, the profession in the United States is now predominantly female and nonveteran. Using archival data and other resources, this article documents the influences on gender and age shifts in the PA profession with related policy perspectives.

HIV testing among heterosexuals at elevated risk for HIV in the District of Columbia: has anything changed over time?

The District of Columbia launched a routine HIV testing initiative in 2006. We examined HIV testing behaviors among heterosexuals at risk for HIV over time using CDC National HIV Behavioral Surveillance data from Washington, DC for the heterosexual cycles from 2006 to 2007 (Cycle 1) and 2010 (Cycle 2). Past year and past 2-year HIV testing across study cycles were compared using Chi square tests.

Linkage, engagement, and viral suppression rates among HIV-infected persons receiving care at medical case management programs in Washington, DC.

Background: The District of Columbia Department of Health funds facilities to provide HIV medical case management (MCM), inclusive of linkage, engagement in care, and treatment adherence support. The objective of this analysis was to identify the differences in the clinical outcomes among HIV-infected persons receiving care at MCM-funded facilities compared with those in nonfunded facilities.

Methods: Newly diagnosed and prevalent HIV-infected persons were identified from the District of Columbia Department of Health surveillance system.

Cultural orientations, parental beliefs and practices, and latino adolescents' autonomy and independence.

Despite the salience of behavioral autonomy and independence to parent-child interactions during middle adolescence, little is known about parenting processes pertinent to youth autonomy development for Latino families. Among a diverse sample of 684 Latino-origin parent-adolescent dyads in Houston, Texas, this study examines how parents' cultural orientations are associated directly and indirectly, through parental beliefs, with parenting practices giving youth behavioral autonomy and independence. Informed by social domain theory, the study's parenting constructs pertain to youth behaviors in an "ambiguously personal" domain-activities that adolescents believe are up to youth to decide, but which parents might argue require parents' supervision, knowledge, and/or decision-making.

A physician assistant rheumatology fellowship.

A rheumatology postgraduate fellowship for physician assistants was inaugurated in 2004 as a pilot initiative to supplement shortages in rheumatologists. An administrative analysis documented that each PA trainee achieved a high level of rheumatology exposure and proficiency. Classes in immunology, rheumatology, and internal medicine augmented clinical training.

Should I call an interpreter?-How do physicians with second language skills decide?

Very little is known about how and when clinicians use their second language skills in patient care and when they rely on interpreters. The purpose of this study was to identify the factors most relevant to physicians' decision-making process when confronting the question of whether their language skills suffice to communicate effectively with patients in particular encounters. We conducted 25 in-depth, semi-structured telephone interviews with physicians in different practice settings who, while not native speakers, routinely interact with LEP patients using second language skills.

HIV among women in the District of Columbia: an evolving epidemic?

The epidemiology of HIV in urban centers of the United States such as the District of Columbia (DC) is dynamic with rates of new HIV and AIDS diagnoses as well as risk factors elevated. Correlates of HIV among heterosexual women extend beyond traditional, individual risk factors to structural factors. The purpose of this study was to compare proportions of HIV and correlates of HIV among women participating in National HIV behavioral surveillance (NHBS) system in 2006-7 (NHBS Cycle 1) and 2010 (NHBS Cycle 2).

Improving the quality of language services delivery: findings from a hospital quality improvement initiative.

Over 24 million individuals in the United States speak English "less than very well" and are considered limited English proficient (LEP). Due to challenges inherent in patient-provider interactions with LEP patients, LEP individuals are at risk for a wide array of negative health consequences. Evidence suggests that having an interpreter present to facilitate interactions between LEP patients and health professionals can mitigate many of these disparities.

Staying cool in a changing climate: Reaching vulnerable populations during heat events.

The frequency and intensity of hot weather events are expected to increase globally, threatening human health, especially among the elderly, poor, and chronically ill. Current literature indicates that emergency preparedness plans, heat health warning systems, and related interventions may not be reaching or supporting behavior change among those most vulnerable in heat events. Using a qualitative multiple case study design, we comprehensively examined practices of these populations to stay cool during hot weather ("cooling behaviors") in four U.

Can E-Gaming Be Useful for Achieving Recommended Levels of Moderate- to Vigorous-Intensity Physical Activity in Inner-City Children?

Objective: The purpose of this study was to compare the energy expenditure of a tailored, interactive genre of e-gaming ("Winds of Orbis: An Active Adventure"; Entertainment Technology Center, Carnegie Mellon, Pittsburgh, PA) ( www.activeadventuregame.com ) with that of a tethered videogame ("Dance Dance Revolution" [DDR]; Konami Digital Entertainment, El Segundo, CA) and with traditional physical education (PE) activities in meeting recommended levels of moderate- to vigorous-intensity physical activity (MVPA).

Pit latrines and their impacts on groundwater quality: a systematic review.

Background: Pit latrines are one of the most common human excreta disposal systems in low-income countries, and their use is on the rise as countries aim to meet the sanitation-related target of the Millennium Development Goals. There is concern, however, that discharges of chemical and microbial contaminants from pit latrines to groundwater may negatively affect human health.

Objectives: Our goals were to a) calculate global pit latrine coverage, b) systematically review empirical studies of the impacts of pit latrines on groundwater quality, c) evaluate latrine siting standards, and d) identify knowledge gaps regarding the potential for and consequences of groundwater contamination by latrines.

Effectiveness of the Smoking Cessation and Reduction in Pregnancy Treatment (SCRIPT) dissemination project: a science to prenatal care practice partnership.

This study evaluated the effectiveness of the Smoking Cessation and Reduction in Pregnancy Treatment (SCRIPT) Program selected by the West Virginia-Right From The Start Project for state-wide dissemination. A process evaluation documented the fidelity of SCRIPT delivery by Designated Care Coordinators (DCC), licensed nurses and social workers who provide home-based case management to Medicaid-eligible clients in all 55 counties. We implemented a quasi-experimental, non-randomized, matched Comparison (C) Group design.

Open-source collaboration for Global Health: Science and Practice.

USAID and the Schools of Public Health at JHU and GWU welcome you to the inaugural issue of GHSP-an open-access, peer-reviewed journal for the global health community, particularly program implementers, to contribute to and benefit from a dialogue based on science and practical programmatic experience.

Regional variations in age at diagnosis and overall survival among patients with chronic myeloid leukemia from low and middle income countries.

Introduction: The epidemiology of chronic myeloid leukemia (CML) in low and middle income countries is limited. As a result, we analyzed a contemporary cohort of patients from low and middle income countries treated with Imatinib through The Glivec(®) International Patient Assistance Program (GIPAP).

Methods: Generalized estimating equations (GEE) and Kaplan-Meier estimation were utilized to test for regional variations in age at diagnosis and overall survival among 33,985 patients from 94 countries.