Mitigating Ethical Risks in Public-Private Partnerships in Public Health.

CONTEXT: Partnerships between the public and private sectors are necessary in public health and health care. Each partner provides skills, resources, and capabilities. When the public sector, including government, enters into a partnership with a nongovernmental or corporate entity, it is important to determine in advance whether there are real or perceived ethical, financial, or programmatic risks to the organization that might need mitigation. PROGRAM: This article describes how the Centers for Disease Control and Prevention has approached assessing ethical considerations of public-private partnerships, especially those involving monetary or in-kind gifts. IMPLEMENTATION: There are practices that can be applied no matter the size or structure of the organization that can lead to transparency and accountability for a potential partnership. DISCUSSION: Examples in this article include a list of practical considerations to review before entering into a new partnership, as well as illustrative anecdotes.

Research ethics and refugee health: a review of reported considerations and applications in published refugee health literature, 2015-2018.

INTRODUCTION: Public health investigations, including research, in refugee populations are necessary to inform evidence-based interventions and care. The unique challenges refugees face (displacement, limited political protections, economic hardship) can make them especially vulnerable to harm, burden, or undue influence. Acute survival needs, fear of stigma or persecution, and history of trauma may present challenges to ensuring meaningful informed consent and establishing trust. We examined the recently published literature to understand the application of ethics principles in investigations involving refugees. METHODS: We conducted a preliminary review of refugee health literature (research and non-research data collections) published from 2015 through 2018 available in PubMed. Article inclusion criteria were: participants were refugees, topic was health-related, and methods used primary data collection. Information regarding type of investigation, methods, and reported ethics considerations was abstracted. RESULTS: We examined 288 articles. Results indicated 33% of investigations were conducted before resettlement, during the displacement period (68% of these were in refugee camps). Common topics included mental health (48%) and healthcare access (8%). The majority (87%) of investigations obtained consent. Incentives were provided less frequently (23%). Most authors discussed the ways in which community stakeholders were engaged (91%), yet few noted whether refugee representatives had an opportunity to review investigational protocols (8%). Cultural considerations were generally limited to gender and religious norms, and 13% mentioned providing some form of post-investigation support. CONCLUSIONS: Our analysis is a preliminary assessment of the application of ethics principles reported within the recently published refugee health literature. From this analysis, we have proposed a list of best practices, which include stakeholder engagement, respect for cultural norms, and post-study support. Investigations conducted among refugees require additional diligence to ensure respect for and welfare of the participants. Development of a refugee-specific ethics framework with ethics and refugee health experts that addresses the need for stakeholder involvement, appropriate incentive use, protocol review, and considerations of cultural practices may help guide future investigations in this population.

Beyond Research Ethics: Novel Approaches of 3 Major Public Health Institutions to Provide Ethics Input on Public Health Practice Activities.

Public health institutions increasingly realize the importance of creating a culture in their organizations that values ethics. When developing strategies to strengthen ethics, institutions will have to take into account that while public health research projects typically undergo thorough ethics review, activities considered public health practice may not be subjected to similar oversight. This approach, based on a research-practice dichotomy, is increasingly being criticized as it does not adequately identify and manage ethically relevant risks to those affected by nonresearch activities. As a reaction, 3 major public health institutions (the World Health Organization, US Centers for Disease Control and Prevention, and Public Health Ontario) have implemented mechanisms for ethics review of public health practice activities. In this article, we describe and critically discuss the different modalities of the 3 approaches. We argue that although further evaluation is necessary to determine the effectiveness of the different approaches, public health institutions should strive to implement procedures to ensure that public health practice adheres to the highest ethical standards.

Key Ethical Issues Discussed at CDC-Sponsored International, Regional Meetings to Explore Cultural Perspectives and Contexts on Pandemic Influenza Preparedness and Response.

BACKGROUND: Recognizing the importance of having a broad exploration of how cultural perspectives may shape thinking about ethical considerations, the Centers for Disease Control and Prevention (CDC) funded four regional meetings in Africa, Asia, Latin America, and the Eastern Mediterranean to explore these perspectives relevant to pandemic influenza preparedness and response. The meetings were attended by 168 health professionals, scientists, academics, ethicists, religious leaders, and other community members representing 40 countries in these regions. METHODS: We reviewed the meeting reports, notes and stories and mapped outcomes to the key ethical challenges for pandemic influenza response described in the World Health Organization's (WHO's) guidance, Ethical Considerations in Developing a Public Health Response to Pandemic Influenza: transparency and public engagement, allocation of resources, social distancing, obligations to and of healthcare workers, and international collaboration. RESULTS: The important role of transparency and public engagement were widely accepted among participants. However, there was general agreement that no "one size fits all" approach to allocating resources can address the variety of economic, cultural and other contextual factors that must be taken into account. The importance of social distancing as a tool to limit disease transmission was also recognized, but the difficulties associated with this measure were acknowledged. There was agreement that healthcare workers often have competing obligations and that government has a responsibility to assist healthcare workers in doing their job by providing appropriate training and equipment. Finally, there was agreement about the importance of international collaboration for combating global health threats. CONCLUSION: Although some cultural differences in the values that frame pandemic preparedness and response efforts were observed, participants generally agreed on the key ethical principles discussed in the WHO's guidance. Most significantly the input gathered from these regional meetings pointed to the important role that procedural ethics can play in bringing people and countries together to respond to the shared health threat posed by a pandemic influenza despite the existence of cultural differences.

Getting Data Right - and Righteous to Improve Hispanic or Latino Health.

Hispanics or Latinos constitute the largest racial/ethnic minority in the United States. They are also a very diverse population. Latino/Hispanic's health varies significantly for subgroups defined by national origin, race, primary language, and migration-related factors (place of birth, immigration status, years of residence in the United States). Most Hispanics speak Spanish at home, and one-third have limited English proficiency (LEP). There is growing awareness on the importance for population health monitoring programs to collect those data elements (Hispanic subgroup, primary language, and migration-related factors) that better capture Hispanics' diversity, and to provide language assistance (translation of data collection forms, interpreters) to ensure meaningful inclusion of all Latinos/Hispanics in national health monitoring. There are strong ethical and scientific reasons for such expansion of data collection by public health entities. First, expand data elements can help identify otherwise hidden Hispanic subpopulations' health disparities. This may promote a more just and equitable distribution of health resources to underserved populations. Second, language access is needed to ensure fair and legal treatment of LEP individuals in federally supported data collection activities. Finally, these strategies are likely to improve the quality and representativeness of data needed to monitor and address the health of all Latino/Hispanic populations in the United States.

Ethical guidelines in pandemic influenza: recommendations of the Ethics Subcommittee of the Advisory Committee of the Director, Centers for Disease Control and Prevention.

Because of the importance of including ethical considerations in planning efforts for pandemic influenza, in February 2005 the Centers for Disease Control and Prevention requested that the Ethics Subcommittee of the Advisory Committee to the Director develop guidance that would serve as a foundation for decision making in preparing for and responding to pandemic influenza. Specifically, the ethics subcommittee was asked to make recommendations regarding ethical considerations relevant to decision making about vaccine and antiviral drug distribution prioritization and development of interventions that would limit individual freedom and create social distancing. The ethics subcommittee identified a number of general ethical considerations including identification of clear goals for pandemic planning, responsibility to maximize preparedness, transparency and public engagement, sound science, commitment to the global community, balancing individual liberty and community interests, diversity in ethical decision making, and commitment to justice. These general ethical considerations are applied to the issues of vaccine and antiviral drug distribution and use of community mitigation interventions.

Strengthening public health ethics at the centers for disease control and prevention.

In early 2005, the Centers for Disease Control and Prevention (CDC) launched an initiative to strengthen leadership in public health ethics. This resulted in the formation of an external Ethics Subcommittee of the Advisory Committee to the Director, an internal CDC Public Health Ethics Committee, and the creation of a new position, the CDC Public Health Ethics Coordinator, to oversee the activities of these two committees and to serve as the main point of contact for public health ethics at the agency. Through this effort, the CDC is collaborating with the Ethics Subcommittee to develop ethical guidance documents that address specific public health program concerns, including pandemic influenza, emergency preparedness and response, and genomics. It is anticipated that as the public health ethics activities grow within the CDC, benefits will be seen in greater participation and partnership with affected stakeholders and strengthened public trust in health recommendations.

Military deployment to the Gulf War as a risk factor for psychiatric illness among US troops.

BACKGROUND: Several studies document an excess of psychiatric symptoms among veterans of the the 1991 Gulf War. However, little is known about the prevalence of psychiatric disorders in those who were deployed to that conflict. AIMS: To compare the 12-month prevalence and associated risk factors for DSM Axis I psychiatric diagnoses between random samples of Gulf War-deployed veterans and veterans of the same era not deployed to the Persian Gulf (era veterans). METHOD: Interview data from 967 Gulf War veterans and 784 era veterans were examined to determine current health status, medical conditions, symptoms and Axis I psychiatric disorders. Logistic regression models evaluated risk factors for psychiatric disorder. RESULTS: Gulf War veterans had a significantly higher prevalence of psychiatric diagnoses, with twice the prevalence of anxiety disorders and depression. Lower rank, female gender and divorced or single marital status were significant independent predictors of psychiatric disorder. CONCLUSIONS: Deployment to the Gulf War is associated with a range of mental health outcomes more than 10 years after deployment.

Perspectives on the use of scientific knowledge for public health practice.

Achieving the goal of increasing quality and years of healthy life is fundamentally based on success in the practice of public health. As our life style changes with time and as public health issues become more global, the practice of public health is enhanced to meet new challenges. In addition to addressing infectious diseases, environmental concerns are gaining attention. New challenges require the modification of the methods of investigations, use of new technologies and application of real-time management of public health emergencies. In many situations, collaborations at the local, regional, national and global levels are needed. This manuscript provides a summary of the approaches to address certain crucial environmental health concerns towards the goal of increasing quality and years of healthy life.

Saudi Arabia-United States collaboration in health research: a formula for success.

The aim of this article is to share our experiences from an international collaborative effort to study health outcomes among Saudi Arabian National Guard (SANG) soldiers following the 1991 Gulf War. By paying particular attention to distinct social and religious customs, geopolitical differences, and unique aspects of the health care system, we achieved a successful international collaboration in health research.

Assessing the potential health impact of the 1991 Gulf War on Saudi Arabian National Guard soldiers.

BACKGROUND: There has been considerable publicity that the 1991 Gulf War may have caused a wide array of health problems in military personnel. Although post-war health outcomes have been studied in US, British, Canadian, Danish, and other deployed troops, this issue has not been previously evaluated in coalition forces native to the Gulf region. METHODS: A collaborative team of US and Saudi health researchers was assembled, data sources evaluated, and hospitalizations among Saudi Arabian National Guard (SANG) soldiers between 1991 and 1999 analysed. Multivariate modelling was used to evaluate differences between 8342 soldiers exposed to combat at Al Khafji and a comparison group of 7270 soldiers in the Riyadh area. RESULTS: Among 15 612 SANG soldiers, we identified 148 with at least one hospitalization over the 9 years following the war. The adjusted rate of hospitalization was higher in the combat-exposed group (risk ratio (RR) = 1.80, 95% confidence interval (CI) 1.25-2.59). No unusual patterns of diagnoses were found and, because the overall number of hospitalizations was low, the absolute difference in risk was found to be very small. CONCLUSIONS: This is the first reported epidemiological investigation of post-war hospitalizations among coalition forces native to the Gulf region that participated in the 1991 Gulf War. A very small increase in hospitalizations was identified in SANG soldiers exposed to combat at Al Khafji. However, because of data limitations, the clinical relevance of this finding should be interpreted with caution. Future collaborative studies to better understand the health effects of deployment should be encouraged.

Postservice mortality in Vietnam veterans: 30-year follow-up.

BACKGROUND: During the 1980s, the postservice mortality component of the Vietnam Experience Study was conducted to examine the health effects of the Vietnam experience. This study was limited by the relatively short follow-up and the young age of the veterans. Thus, a follow-up mortality investigation on this cohort was undertaken to further assess the impact of the Vietnam experience on chronic conditions. METHODS: Vital status and underlying cause-of-death data on the Vietnam Experience Study cohort (18 313 male US Army veterans) were retrospectively ascertained from the end of the original study through 2000. Cox proportional hazards regression was used to calculate crude and adjusted rate ratios (RRs) for all-cause and cause-specific mortality, comparing Vietnam and non-Vietnam veterans. RESULTS: All-cause mortality was 7% higher in Vietnam vs non-Vietnam veterans during 30-year follow-up (95% confidence interval [CI], 0.97-1.18). The excess mortality among Vietnam veterans was isolated to the first 5 years after discharge from active duty and resulted from an increase in external causes of death (RR, 1.62; 95% CI, 1.16-2.26). Cause-specific analyses revealed no difference in disease-related mortality. Vietnam veterans, however, experienced excess unintentional poisoning (RR, 2.26; 95% CI, 1.12-4.57) and drug-related (RR, 1.70; 95% CI, 1.01-2.86) deaths throughout follow-up. CONCLUSIONS: Vietnam veterans continued to experience higher mortality than non-Vietnam veterans from unintentional poisonings and drug-related causes. Death rates from disease-related chronic conditions, including cancers and circulatory system diseases, did not differ between Vietnam veterans and their peers, despite the increasing age of the cohort (mean age, 53 years) and the longer follow-up (average, 30 years).

Gulf War veterans with anxiety: prevalence, comorbidity, and risk factors.

BACKGROUND: Veterans of the first Gulf War have higher rates of medical and psychiatric symptoms than nondeployed military personnel. METHODS: To assess the prevalence of and risk factors for current anxiety disorders in Gulf War veterans, we administered a structured telephone interview to a population-based sample of 4886 military personnel from Iowa at enlistment. Participants were randomly drawn from Gulf War regular military, Gulf War National Guard/ Reserve, non-Gulf War regular military, and non-Gulf War National Guard/Reserve. Medical and psychiatric conditions were assessed through standardized interviews and questionnaires in 3695 subjects (76% participation). Risk factors were assessed using multivariate logistic regression models. RESULTS: Veterans of the first Gulf War reported a markedly higher prevalence of current anxiety disorders than nondeployed military personnel (5.9% vs. 2.8%; odds ratio = 2.1; 95% confidence interval = 1.3-3.1), and their anxiety disorders are associated with co-occurring psychiatric disorders. Posttraumatic stress disorder, panic disorder, and generalized anxiety disorder were each present at rates nearly twice expected. In our multivariate model, predeployment psychiatric treatment and predeployment diagnoses (posttraumatic stress disorder, depression, or anxiety) were independently associated with current anxiety disorder. Participation in Gulf War combat was independently associated with current posttraumatic stress disorder, panic disorder, and generalized anxiety disorder. CONCLUSIONS: Current anxiety disorders are relatively frequent in a military population and are more common among Gulf War veterans than nondeployed military personnel. Predeployment psychiatric difficulties are robustly associated with the development of anxiety. Healthcare providers and policymakers need to consider panic disorder and generalized anxiety disorder, in addition to posttraumatic stress disorder, to ensure their proper assessment, treatment, and prevention in veteran populations.

Health-related quality of life of U.S. military personnel: a population-based study.

OBJECTIVE: This study evaluated the association between military service and health-related quality of life (HRQOL), using a large, population-based sample of U.S. adults. METHODS: Participants in the 2000 Behavioral Risk Factor Surveillance System were characterized as active duty personnel (N = 1,163), reserves (N = 1,055], veterans (N = 22,558), or no military service (N = 141,620). HRQOL was described by sex and military status. Logistic regression was used to calculate sex-specific adjusted odds ratios. RESULTS: Active duty men were more likely than men without military service to report 14 or more days of activity limitation, pain, and not enough rest in the past 30 days. Reserve personnel reported better overall HRQOL than nonmilitary participants, and no difference in HRQOL was observed between veterans and persons with no military service. CONCLUSIONS: Recommendations are made to monitor HRQOL of active duty and reserve personnel over time and to include HRQOL measures in military-based surveys of active duty troops.

Serum dioxin and psychological functioning in U.S. Air Force veterans of the Vietnam War.

Using the Minnesota Multiphasic Personality Inventory and the Millon Clinical Multiaxial Inventory, we assessed the psychological functioning of U.S. Air Force veterans exposed to Agent Orange and its contaminant, 2,3,7,8-tetrachlodibenzo-p-dioxin (dioxin), during the Vietnam War. Index subjects were veterans of Operation Ranch Hand (N = 1,109). Comparisons (N = 1,493) were U.S. Air Force veterans not involved with spraying herbicides. We found few consistent psychological abnormalities associated with serum dioxin levels. Ranch Hand veterans with higher dioxin levels showed some difficulties in anxiety, somatization, depression, and a denial of psychological factors. However, those with background levels also showed indications of emotional distress, primarily in emotional numbing and lability; a guarded, suspicious, and withdrawn style of relating to others; and unusual thoughts or behaviors.

Posttraumatic stress disorder and self-reported physical health status among U.S. Military personnel serving during the Gulf War period: a population-based study.

The objective of this study was to investigate the relation between posttraumatic stress disorder (PTSD) and perceived physical health. Participants included 3,682 Gulf War veterans and control subjects of the same era who completed a telephone survey about their health status. PTSD was assessed using the PTSD Checklist-Military Version. Veterans screening positive for PTSD reported significantly more physical health symptoms and medical conditions than did veterans without PTSD. They were also more likely to rate their health status as fair or poor and to report lower levels of health-related quality of life. The results of this study are consistent with studies of other combat veterans and provide further support for an association between PTSD and adverse physical health outcomes. Stressful or traumatic life events, such as those encountered during a rapid military deployment and conflict, are associated with a variety of adverse health effects. These health effects may manifest themselves in both psychological and physical outcomes. Health care providers must be attentive to recognize and evaluate both of these dimensions.

Methodologic issues in a population-based health survey of Gulf War veterans.

This report describes the principal methods used in the development, conduct, and analysis of the research study "Health Assessment of Persian Gulf War Veterans from Iowa" (Iowa Gulf War Study). The methods presented include an outline of the organizational structure, study timeline, hypotheses, outcome definitions, and study design. Adhering to a strict timeline, the study protocol and instruments were developed, and a stratified sample of 3,695 military personnel (76% participation) was located and surveyed by structured telephone interview. The study tracked personnel from all service branches residing nationally and internationally, including those discharged from service. This study required development and implementation of methods appropriate to analysis of data collected in a complex sampling framework and methodological procedures to ensure scientific rigor in a highly public and politicized environment. Statistical analyses were conducted on a priori health outcomes and required development of methods to compute Cochran-Mantel-Haenszel adjusted rate differences. This environment facilitated rapid implementation, critique by scientific and public advisors, a high participation rate, and rapid publication.

The Recruit assessment Program: a program to collect comprehensive baseline health data from U.S. military personnel.

Pilot testing has begun on the Recruit Assessment Program (RAP). The RAP is a proposed Department of Defense (DoD) program for the routine collection of baseline demographic, medical, psychosocial, occupational, and health risk factor data from all U.S. military personnel at entry into the armed forces. The RAP currently uses an optically scannable paper questionnaire, which will provide data for the first building block of an electronic medical record within the DoD and the Department of Veterans Affairs. The RAP will serve several important functions, including automating enrollment into the military health care system, improving patient care and preventive medicine efforts, and providing critical data for investigations of health problems among military personnel and veterans. If the feasibility of the RAP is demonstrated and the program is fully implemented throughout the DoD, it could provide a substantial improvement in health care delivery. For the first time, DoD and Department of Veterans Affairs physicians, public health officers, and researchers will have access to comprehensive baseline health status data.