Fortification of corn masa flour with folic acid in the United States.

Food fortification is an effective public health tool for addressing micronutrient deficiencies. The mandatory fortification of enriched cereal grains (e.g., wheat flour) with folic acid, which began in the United States in 1998, is an example of a successful intervention that significantly reduced the rate of neural tube defects (NTDs). However, despite the drop in NTD rates across all racial/ethnic groups after fortification, Hispanics continue to have the highest rates of this condition. One possible way to reduce this disparity is to fortify corn masa flour to increase the overall intake of folic acid in Hispanic women. We present the available evidence in favor of this approach, address possible safety issues, and outline next steps in the fortification of corn masa flour with folic acid in the United States.

Surgeon General's Conference on the Prevention of Preterm Birth.

To address the serious and seemingly intractable problem of preterm birth, the Surgeon General's Conference on the Prevention of Preterm Birth convened many of the country's experts from the public and private sectors of research, public health, and health care delivery to discuss preventive strategies. The purpose of the conference was to increase awareness of preterm birth in the United States, review key findings and reports issued by experts in the field, and establish an agenda for activities in both the public and private sectors to mitigate the problem. The six work groups created focused on biomedical research, epidemiological research, psychosocial and behavioral factors in preterm birth, professional education and training, outreach and communication, and quality of care and health services. Several cross-cutting issues between the work groups were identified, and the conference concluded with the request to the Surgeon General to make the prevention of preterm birth a national public health priority. Reaching this goal through the implementation of the conference recommendations will require new resources to create broad-based research capacity, a vigorous national vital records system, multidisciplinary intervention programs, careful study of factors contributing to racial and ethnic disparities, reinvigorated health professional and consumer education programs, and access to high-quality preconception and perinatal healthcare for all Americans. Clinicians must be adequately informed to initiate activities to prevent this serious problem. Recommendations from this conference will inform Congress and create a national agenda to address the identification of the causes, risk factors, prevention, and treatment of preterm birth.

Community engagement in epidemiological research.

OBJECTIVE: Engaging communities has become a critical aspect of planning and implementing health research. The role community engagement should play in epidemiological and observational research remains unclear since much of this research is not directly generated by community concerns and is not interventional in nature. The National Children's Study (NCS), an observational longitudinal study of 100,000 children and their families, provides a model to help guide the development of community engagement strategies in epidemiologic research. METHODOLOGY: This manuscript describes community engagement activities of the NCS during the planning phases of the study. RESULTS: There are many challenges of community engagement in epidemiologic research particularly before the actual research sites are determined. After communities of interest are designated many further issues must be resolved, including: defining the specific community, determining which residents or institutions represent the identified community, and developing trust and rapport through respectful engagement. CONCLUSIONS: Community engagement is critical to the long-term success of any longitudinal epidemiologic study. A partnership with the community should be formed to ensure mutual respect and the establishment of an enduring relationship. Genuine community engagement offers the hope of enhancing recruitment, retention, and participant satisfaction.

Roadmap for the protection of disaster research participants: findings from the World Trade Center Evacuation Study.

INTRODUCTION: This report addresses the development, implementation, and evaluation of a protocol designed to protect participants from inadvertent emotional harm or further emotional trauma due to their participation in the World Trade Center Evacuation (WTCE) Study research project. This project was designed to identify the individual, organizational, and structural (environmental) factors associated with evacuation from the World Trade Center Towers 1 and 2 on 11 September 2001. METHODS: Following published recommended practices for protecting potentially vulnerable disaster research participants, protective strategies and quality assurance processes were implemented and evaluated, including an assessment of the impact of participation on study subjects enrolled in the qualitative phase of the WTCE Study. RESULTS: The implementation of a protocol designed to protect disaster study participants from further emotional trauma was feasible and effective in minimizing risk and monitoring for psychological injury associated with study participation. CONCLUSIONS: Details about this successful strategy provide a roadmap that can be applied in other post-disaster research investigations.

Ethical issues in neonatal research involving human subjects.

Research involving critically ill neonates creates many ethical challenges. Neonatal clinical research has always been hard to perform, is very expensive, and may generate some unique ethical concerns. This article describes some examples of historical and modern controversies in neonatal research, discusses the justification for research involving such vulnerable and fragile patients, clarifies current federal regulations that govern research involving neonates, and suggests ways that clinical investigators can develop and implement ethically grounded human subjects research.

Regulating research with human subjects--is the system broken?

There has been a great deal of criticism of the system to regulate research and protect the interests of research participants. Structural problems in the system result from the nature of current research and the regulatory process that was created over thirty years ago. Procedural problems exist because local IRBs show wide variation in practices, resources, quality and experience. Assessment of performance is perhaps the most important problem facing the system since there are no standard measures of outcome or performance for the system as a whole or to assess local IRBs. Is the system broken? No, but it is straining under the weight of a changed research environment and inadequate resources. It has the capacity to respond to the concerns of both the research community and the public by the thoughtful application of present regulations and the creation of performance assessment strategies.

Urban health: a look out our windows.

Approximately 80% of Americans live in cities or immediately adjacent communities. Such urban environments are complex amalgams of people of disparate backgrounds, economic status, and expectations, with extraordinary disparities in health status and outcomes between groups just blocks apart. Urban health as a framing paradigm is of recent vintage and offers a perspective on health and disease that integrates clinical medicine and public health and draws on the social and political sciences to seek understanding of the impact of cities on the health of populations and individuals. Ironically, disparate outcomes and increased mortality among poor minority populations in cities are not primarily related to the consequences of the urban epidemics of drugs and violence but rather are due to the increased prevalence and severity of common diseases such as asthma, cardiovascular disease, diabetes, and kidney disease. Several factors may be responsible for such disparities, including stress, racism, perceptions of deprivation, economic inequalities, and lack of access to quality health care. It is time for leaders in medical education and health care delivery to focus on the populations that surround their institutions in order to study urban health and meet the challenge of caring for all the residents of our cities.

Urban bioethics: adapting bioethics to the urban context.

Urban bioethics is an area of inquiry within the discipline of bioethics that focuses on ethical issues, problems, and conflicts relating to medicine, science, health care, and the environment that typically arise in urban settings. Urban bioethics challenges traditional bioethics (1) to examine value concerns in a multicultural context, including issues related to equity and disparity, and public health concerns that may highlight conflict between individual rights and the public good, and (2) to broaden its primary focus on individual self-determination and respect for autonomy to include examination of the interests of family, community, and society. Three features associated with urban life-density, diversity, and disparity-affect the health of urban populations and provide the substrate for identifying ethical concerns and value conflicts and creating interventions to affect population health outcomes. The field of urban bioethics can be helpful in creating ethical foundations and principles for public health practice, developing strategies to respect diversity in health policy in a pluralistic society, and fostering collaborative work among educators, social scientists, and others to eliminate bias among health professionals and health care institutions to enhance patients' satisfaction with their care and ultimately affect health outcomes. Educational programs at all levels and encompassing all health professions are needed as a first step to address the perplexing and important problem of eliminating health disparities. Urban bioethics is both contributing to the social science literature in this area and helping educators to craft interventions to affect professional attitudes and behaviors.

Enhancing palliative care education in medical school curricula: implementation of the palliative education assessment tool.

The authors report the results of a Robert Wood Johnson Foundation-funded project that catalyzed New York State medical schools to develop and implement strategic plans for curricular change to enhance palliative care education. The project used the Palliative Education Assessment Tool for curricular mapping of palliative care education throughout each school's four-year curriculum and used site visits to facilitate strategic planning within each institution. Of the 14 New York State medical schools, 13 participated in the project. Ten provided strategic plans for change, with a total of 71 specific goals (median = 5 per school). Of these goals, 67 (94.4%) had been implemented or were in the active-planning process one year after the plans were created. Overall, palliative care content was enhanced in four curricular areas: basic science courses, ethics and humanities courses, clerkship rotations, and faculty development in palliative care. The process of self-assessment, curriculum mapping of a specific thematic area, and strategic planning for change appears to have successfully enhanced the palliative care content in the medical schools' curricula.

Clinical research in the private office setting--ethical issues.

A new model for performing clinical investigations has emerged in the United States which utilizes networks of physicians practicing in private office settings. This arrangement has sparked much controversy because of the potential conflicts of interest inherent in the dual roles of physician as clinician and investigator as well as the significant direct financial gains reported by some physicians which might impact on the interests of research subjects. We describe some of the ethical concerns and propose some procedural guidelines to safeguard the interests of research subjects participating in clinical trials in private physician offices. These safeguards include: requiring education of all investigators in research ethics, limiting financial incentives, disclosure to subjects of potential conflicts and financial arrangements, creation of an independent resource available to subjects to discuss concerns and answer questions, and development of educational materials to inform all potential subjects about important issues related to clinical research.

Posttraumatic stress reactions in new York City children after the September 11, 2001, terrorist attacks.

OBJECTIVE: To assess the prevalence of posttraumatic stress reactions (PTSR) in New York City (NYC) children following the September 11, 2001, attacks and determine the key predictors of PTSR. METHODS: Cross-sectional random digit-dial survey in NYC of parents of children 4-17 years old 4 months after the attacks. PTSR in children was measured using the 20-item Posttraumatic Stress Disorder Reaction Index-Child Revision, with parents as respondents. RESULTS: Overall, 18% of NYC children had "severe" or "very severe" PTSR, and 66% had "moderate" PTSR. In a multivariate model, parental posttraumatic stress disorder (PTSD; odds ratio [OR] = 4.50; P <.01), the parent crying in front of the child (OR = 3.19; P <.001), seeing 3 or more graphic images of the disaster on television (OR = 3.18; P <.01), and living in Manhattan were associated with severe or very severe PTSR in children. CONCLUSIONS: A substantial proportion of NYC children had severe or very severe PTSR after September 11, and most children exhibited at least moderate PTSR. These findings suggest an enhanced role for primary care physicians, particularly pediatricians, for screening, treatment, and referral (coupled with appropriate training and reimbursement), especially in light of continued terrorist threats. These findings also have implications for advice that pediatricians can give to parents about limiting disaster-related television exposure and children's need for emotional support.

The private practicing physician-investigator: ethical implications of clinical research in the office setting.

Drug companies are moving their research from academic medical centers to physicians' private offices. The shift brings in more subjects, and could mean faster and better results. It also changes the physician's relationship to patients, dangles monetary lures in front of physicians, and could produce subjects who don't understand what they're participating in and results that are unreliable.

Addressing ethical issues in everyday practice.

In primary-care practice, just as in critical care, ethical dilemmas challenge pediatricians to make choices in the best interests of their patients. Parents are important to the growth and development of children and have broad responsibility for making virtually all decisions regarding nutrition, clothing, housing, education, religion, and medical care. Society's deference to parental choice promotes the value of family integrity, ensures the availability of an identifiable decision maker, and acknowledges the legitimate role parents play in shaping their child's development. However, pediatricians have obligations to assess and advocate for the best interests of their patients. This requires that physicians reach out to their patients and take the time to listen to children and to involve them in their own care. The proper role of a child in planning care depends less on chronologic age than on developmental and personal capacity. Even young children have a keen awareness of their own clinical situations and options and should be involved as best as is possible in decision making. All decision making for children should be collaborative among patients, parents, and professionals. A situation including an involved child, an informed parent, and a caring and compassionate caregiver working collaboratively is most likely to result in optimal decisions for pediatric patients. Bartholome concluded in 1995 that pediatricians should respect children for the persons they are in the process of becoming by being willing to assist them to participate to the extent of their capacity in making decisions about their health. Combining that view with fostering respect for the strongly held beliefs and values of parents is the direction pediatricians should travel to make decisions in the best interests of children.