The Forest for the Trees: A Systems Approach to Human Health Research

We explore the relationship between current research directions in human health and environmental and public health policy. Specifically, we suggest there is a link between the continuing emphasis in biomedical research on individualized, therapeutic solutions to human disease and the increased reliance on individual choice in response to environmental and/or public health threats. We suggest that continued research emphasis on these traditional approaches to the exclusion of other approaches will impede the discovery of important breakthroughs in human health research necessary to understand the emerging diseases of today. We recommend redirecting research programs to interdisciplinary and population-focused research that would support a systems approach to fully identifying the environmental factors that contribute to disease burden. Such an approach would be able to address the interactions between the social, ecological, and physical aspects of our environment and explicitly include these in the evaluation and management of health risks from environmental exposures

Fish Consumption and Mercury Exposure among Louisiana Recreational Anglers

Ba c k g r o u n d: Methylmercury (MeHg) exposure assessments among average fish consumers in the United States may underestimate exposures among U.S. subpopulations with high intakes of region-ally specific fish. obj e c t i v e s: We examined relationships among fish consumption, estimated mercury (Hg) intake, and measured Hg exposure within one such potentially highlyexposed group, recreational anglers in the state of Louisiana, USA. Me t h o d s: We surveyed 534 anglers in 2006 using interviews at boat launches and fishing tourna-ments combined with an Internet-based survey method. Hair samples from 402 of these anglers were collected and analyzed for total Hg. Questionnaires provided information on species-specific fish consumption during the 3 months before the survey. re s u l t s: Anglers’ median hairHg concentration was 0.81 μg/g (n = 398; range, 0.02–10.7 μg/g);40% of participants had levels >1 μg/g, which approximately corresponds to the U.S. Environmental Protection Agency’s reference dose. Fish consumption and Hg intake were significantly positively associated with hairHg. Participants reported consuming nearly 80 different fish types, many of which are specific to the region. Unlike the general U.S. population, which acquires most of its Hg from commercial seafood sources, approximately 64% of participants’ fish meals and 74% of their estimated Hg intake came from recreationally caught seafood. co n c l u s i o n s: Study participants had relatively elevated hairHg concentrations and reported con-sumption of a wide variety of fish, particularly locally caught fish. This group represents a highlyexposed subpopulation with an exposure profile that differs from fish consumers in other regions of the United States, suggesting a need for more regionallyspecific exposure estimates and public health advisories.ISSN:1552-9924ISSN:0091-676

Sharing clinical research data in the United States under the health insurance portability and accountability act and the privacy rule

Sharing of final research data from clinical research is an essential part of the scientific method. The U.S. National Institutes of Health require some grant applications to include plans for sharing final research data, which it defines as the factual materials necessary to document, support, and validate research findings. In the U.S., however, the Privacy Rule adopted under the Health Insurance Portability and Accountability Act impedes the sharing of final research data. In most situations, final research data may be shared only where all information that could possibly be used to identify the subject has been deleted, or where the subject has given authorization for specific research, or an Institutional Review Board has granted a waiver

EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA); Scientific Opinion on principles for deriving and applying Dietary Reference Values

This Opinion of the EFSA Panel on Dietetic products, Nutrition, and Allergies (NDA) deals with the general principles for development and application of Dietary Reference Values (DRVs). These quantitative reference values for nutrient intakes for healthy individuals and populations are based on health criteria. Derived from DRVs, nutrients goals and recommendations take into account other criteria such as food composition or dietary habits, and may be used for assessment and planning of diets. It is proposed to derive the following DRVs: 1) Population Reference Intakes (PRI), 2) Average Requirement (AR), 3) Lower Threshold Intake (LTI), 4) Adequate Intake (AI), 5) Reference Intake ranges for macronutrients (RI). Nutrient requirements differ with age, sex and physiological condition. The Panel proposes to define the age ranges used for each nutrient on a case-by-case basis depending on the available data. For the age group < 6 months requirements are considered to be equal to the supply from breast- milk, except in those cases where this does not apply. Separate reference values will be established for pregnant and lactating women. Interpolation or extrapolation between population groups will be used in instances where no data are available for defined age and sex groups

Bringing together emerging and endemic zoonoses surveillance: shared challenges and a common solution

Early detection of disease outbreaks in human and animal populations is crucial to the effective surveillance of emerging infectious diseases. However, there are marked geographical disparities in capacity for early detection of outbreaks, which limit the effectiveness of global surveillance strategies. Linking surveillance approaches for emerging and neglected endemic zoonoses, with a renewed focus on existing disease problems in developing countries, has the potential to overcome several limitations and to achieve additional health benefits. Poor reporting is a major constraint to the surveillance of both emerging and endemic zoonoses, and several important barriers to reporting can be identified: (i) a lack of tangible benefits when reports are made; (ii) a lack of capacity to enforce regulations; (iii) poor communication among communities, institutions and sectors; and (iv) complexities of the international regulatory environment. Redirecting surveillance efforts to focus on endemic zoonoses in developing countries offers a pragmatic approach that overcomes some of these barriers and provides support in regions where surveillance capacity is currently weakest. In addition, this approach addresses immediate health and development problems, and provides an equitable and sustainable mechanism for building the culture of surveillance and the core capacities that are needed for all zoonotic pathogens, including emerging disease threats

Developing a conceptual framework for an evaluation system for the NIAID HIV/AIDS clinical trials networks

Globally, health research organizations are called upon to re-examine their policies and practices to more efficiently and effectively address current scientific and social needs, as well as increasing public demands for accountability

Conducting Science in Disasters: Recommendations from the NIEHS Working Group for Special IRB Considerations in the Review of Disaster Related Research.

Research involving human subjects after public health emergencies and disasters may pose ethical challenges. These challenges may include concerns about the vulnerability of prospective disaster research participants, increased research burden among disaster survivors approached by multiple research teams, and potentially reduced standards in the ethical review of research by institutional review boards (IRBs) due to the rush to enter the disaster field. The NIEHS Best Practices Working Group for Special IRB Considerations in the Review of Disaster Related Research was formed to identify and address ethical and regulatory challenges associated with the review of disaster research. The working group consists of a diverse collection of disaster research stakeholders across a broad spectrum of disciplines. The working group convened in July 2016 to identify recommendations that are instrumental in preparing IRBs to review protocols related to public health emergencies and disasters. The meeting included formative didactic presentations and facilitated breakout discussions using disaster-related case studies. Major thematic elements from these discussions were collected and documented into 15 working group recommendations, summarized in this article, that address topics such as IRB disaster preparedness activities, informed consent, vulnerable populations, confidentiality, participant burden, disaster research response integration and training, IRB roles/responsibilities, community engagement, and dissemination of disaster research results. https://doi.org/10.1289/EHP237

The Ambulatory Pediatric Association Fellowship in Pediatric Environmental Health: A 5-Year Assessment

Background: Evidence is mounting that environmental exposures contribute to causation of disease in children. Yet few pediatricians are trained to diagnose, treat, or prevent disease of environmental origin. Objectives: To develop a cadre of future leaders in pediatric environmental health (PEH), the Ambulatory Pediatric Association (APA) launched a new 3-year fellowship in 2001—the world’s first formal training program in PEH. Sites were established at Boston Children’s Hospital, Mount Sinai School of Medicine, George Washington University, University of Cincinnati, and University of Washington. Fellows are trained in epidemiology, biostatistics, toxicology, risk assessment, and preventive medicine. They gain clinical experience in environmental pediatrics and mentored training in clinical research, policy development, and evidence-based advocacy. Thirteen fellows have graduated. Two sites have secured follow-on federal funding to enable them to continue PEH training. Discussion: To assess objectively the program’s success in preparing fellows for leadership careers in PEH, we conducted a mailed survey in 2006 with follow-up in 2007. Conclusions: Fifteen (88%) of 17 fellows and graduates participated; program directors provided information on the remaining two. Nine graduates are pursuing full-time academic careers, and two have leadership positions in governmental and environmental organizations. Ten have published one or more first-authored papers. Seven graduates are principal investigators on federal or foundation grants. The strongest predictors of academic success are remaining affiliated with the fellowship training site and devoting <20% of fellowship time to clinical practice. Conclusion: The APA fellowship program is proving successful in preparing pediatricians for leadership careers in PEH

A randomized cross over trial of tolerability and compliance of a micronutrient supplement with low iron separated from calcium vs high iron combined with calcium in pregnant women [ISRCTN56071145]

BACKGROUND: Prenatal micronutrient combinations with high iron content are associated with high rates of gastrointestinal symptoms. This coupled with nausea and vomiting of pregnancy results in women often discontinuing their multivitamins. A new prescription supplement (PregVit(®)) that separates iron from calcium in two tablets – morning and evening, has lower elemental iron content (35 mg), but results in similar extent of iron absorption when compared to another supplement containing (60 mg) of elemental iron (Materna(®)). The objectives of this study were to compare tolerability and compliance with PregVit(® )vs. a supplement with high iron content (Materna(®)), in pregnant women. METHODS: Randomized, crossover open labeled study in 135 pregnant women attending outpatient clinics in Ontario and Quebec. RESULTS: Use of PregVit(® )was associated with a 30% reduction in constipation rate as compared to Materna(®). Both products demonstrated similar compliance rates. Compliance of Materna(® )was negatively associated with the severity of nausea and vomiting of pregnancy. No such correlation was found for PregVvit(®). CONCLUSION: PregVit(®), a supplement with lower iron content (35 mg), has significantly decreased constipation rates as compared to 60 mg iron- Materna and has similar compliance rates. High iron content in multivitamin supplements is associated with adverse effects in pregnancy

Does the history of food energy units suggest a solution to "Calorie confusion"?

The Calorie (kcal) of present U.S. food labels is similar to the original French definition of 1825. The original published source (now available on the internet) defined the Calorie as the quantity of heat needed to raise the temperature of 1 kg of water from 0 to 1°C. The Calorie originated in studies concerning fuel efficiency for the steam engine and had entered dictionaries by 1840. It was the only energy unit in English dictionaries available to W.O. Atwater in 1887 for his popular articles on food and tables of food composition. Therefore, the Calorie became the preferred unit of potential energy in nutrition science and dietetics, but was displaced when the joule, g-calorie and kcal were introduced. This article will explain the context in which Nicolas Clément-Desormes defined the original Calorie and the depth of his collaboration with Sadi Carnot. It will review the history of other energy units and show how the original Calorie was usurped during the period of international standardization. As a result, no form of the Calorie is recognized as an SI unit. It is untenable to continue to use the same word for different thermal units (g-calorie and kg-calorie) and to use different words for the same unit (Calorie and kcal). The only valid use of the Calorie is in common speech and public nutrition education. To avoid ongoing confusion, scientists should complete the transition to the joule and cease using kcal in any context