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9 Health Monitoring and Research Programs
Pages 409-460

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From page 409...
... In addition, VA also asked the committee to identify areas requiring further study in order to assess the potential health effects in the descendants of veterans of any era and to provide guidance on how such research might be conducted. To address the latter task, the committee was requested to do the following: • develop a framework for a health monitoring or screening program that would be applicable to all veterans and their descendants; • determine the feasibility of conducting an epidemiologic study on generational health effects in veterans and their descendants; and • assess the scope and methodology for conducting research, including the use of animal models, on generational health effects.
From page 410...
... By design, the HMRP should create an infrastructure for health monitoring at health care facilities within VA as well as seek participation of health care organizations and providers outside of VA that are involved in providing care to veterans, their partners, and their descendants. This is particularly important given the necessary involvement of partners and children of veterans who may not be receiving care within VA facilities.
From page 411...
... FRAMEWORK FOR A HEALTH MONITORING AND RESEARCH PROGRAM The committee designed a general framework (see Figure 9-1) applicable to any veteran era that can serve as a starting point for a research program.
From page 412...
... The program should begin by defining the scope of the health monitoring efforts. This scope will guide the recruitment, enrollment, and engagement of participants -- active-duty service members, reservists, veterans, partners, and their descendants -- now and in the future, as well as the collection and maintenance of the data for each participant.
From page 413...
... A second priority might be to decide on the epidemiologic studies that are to be carried out with data from the health monitoring data repositories or that address other critical research questions. The scope of the HMRP will be a major determinant of the overall value of the data and the costs of recruiting and following up on participants over the long term.
From page 414...
... (2012) used the DoD Birth and Infant Health Registry to identify live infants born to deployed men or women between 2004 and 2007 and categorized veterans as being within a specified distance of a burn pit.
From page 415...
... become pregnant. Study Design Various methods can be used to study human health outcomes, including screening, health monitoring, and research.
From page 416...
... Veterans evaluates the im pact of deployment and deployment related-exposures on 30,000 men and women veterans of Operation Enduring Freedom/Operation Iraqi Freedom. • The Million Veteran Program, which is sponsored by VA, collects DNA and other biological samples and also health and exposure information (VA and DoD Resources for Study of Generational Health Effects)
From page 417...
... For example, VA has conducted three waves for its National Health Survey of Gulf War Era Veterans and Their Families (Dursa et al., 2016) , has launched the Health Study for a New Generation of U.S.
From page 418...
... , are less common and are not included in the table. Study designs that have particular relevance for the HMRP include perinatal and birth cohorts such as the National Collaborative Perinatal Project conducted by NIH between 1959–1974, which obtained information on pre- and postnatal child health for 58,000 pregnancies in the United States (NARA, 2015)
From page 419...
... In addition to the types of epidemiologic studies presented in Table 9-1, ecologic studies may also provide valuable information about the possible health effects of various exposures. In these studies, a population or community is observed, and disease rates and exposures are measured in each of a series of populations.
From page 420...
... Recruitment and Engagement In Figure 9-1, the Volume 11 committee provides a framework for assessing the generational health effects in service members, veterans, and their descendants, including men and women who enlist in the military after an HMRP is established. The HMRP begins recruitment at enlistment to provide a baseline, then continues throughout the veterans' lives.
From page 421...
... Although the VA has extensive experience in large veteran cohort studies, there have been concerns that the response rate for many of its epidemiologic studies is low. Therefore, the committee suggests that VA explore innovative methods to increase recruitment and retention.
From page 422...
... VSOs may also be helpful as part of a public communication campaign to generate interest and enhance recruitment efforts. Partners Establishing a comprehensive HMRP for generational health effects cannot be based on the deployment exposures and reproductive health of active-duty service members and veterans alone.
From page 423...
... After the children reach the legal age of consent, they would provide their own information, as discussed below. Children and Grandchildren As the overarching goal of any veteran HMRP focused on generational health effects is to determine if those effects occur in the descendants of active-duty service members potentially exposed to toxicants during deployment, it is critical to follow these descendants for at least two generations -- that is, at least through the service members' children and grandchildren.
From page 424...
... Sampling of Study Subjects Sampling is used as a selection process to identify a representative population of the target group because costs can limit the feasibility of carrying out a hypothesis-driven research study in the entire target population. The selection of the study population and comparison population is an important consideration in an epidemiologic study.
From page 425...
... An HMRP should be designed to collect data in three key dimensions: • biological samples to include a person's genome, epigenome, proteome, microbiome, physiology, metabolome/exposome, and health status; • environmental factors to include exposures to biological, physical, and chemical agents in air, water, and soil; and • personal and social factors to include occupations, lifestyle habits, education, life events, and neighborhood. Together these factors constitute the foundation for understanding the impact of potential deployment exposures associated with service on the health of the individual and of his or her descendants.
From page 426...
... A service member's EHR can be used to track his or her health from the time of entry into the military until separation. As such, the EHR is a valuable resource for health monitoring which provides baseline data and health effects that may be recorded before (each service member must have a physical prior to deployment)
From page 427...
... Although HMRP participants may sign medical release forms that allow researchers to access their health care records from multiple private health care providers, the data may be in a format that cannot be efficiently handled, such as existing in different EHR operating systems or as hard copies of test results or as large hospitalization records that to date are available only as paper; the latter may be particularly true for older records, such as health records from the Vietnam War era. The fragmentation of the private health care system in the United States adds to the complexity of designing health monitoring systems for service members and veterans.
From page 428...
... The process might include regular, periodic surveys of veterans' and descendants' health status along with permission to access medical records in the event of reported adverse health effects. The committee recognizes that regardless of which veteran cohort is monitored, data collection after a veteran separates from the military may provide a challenge because veterans may receive health care in different places, including DoD, VA, private health care providers, and government providers (e.g., state or local health clinics)
From page 429...
... At a minimum, blood, urine, and semen2 samples should be collected at entry into the military, prior to each deployment, and after each deployment with the optional collection of saliva and hair. Upon separation from the military, veterans participating in the health monitoring system could be requested to provide additional samples, including hair and saliva, depending on the research questions that are being addressed.
From page 430...
... PTSD) Health Effects Comprehensive assessments Comprehensive assessments of health Comprehensive assessments of health of health status (vital signs, status (vital signs, weight)
From page 431...
... Exposure Assessment The primary reason to distinguish among veteran cohorts is that deployment exposures and health outcomes or status may be vastly different from one cohort to another. For example, many Vietnam veterans were exposed to a number of herbicides that included the contaminant 2,3,7,8-tetrachlorodibenzop-dioxin (TCDD, or dioxin)
From page 432...
... sample from the newborn, which is collected as part of all newborn screening programs. Other information to be collected from partners includes the same lifecourse exposure data collected for service members and veterans, occupational and recreational/environmental exposures, a comprehensive assessment of health status (e.g., vital signs, weight, presence of disease)
From page 433...
... Several health outcomes should be assessed for veterans' children -- specifically, prenatal and neonatal health (e.g., fetal growth, preterm birth, birth defects, sex ratio) ; neurodevelopment; growth (e.g., weight, height, head and waist circumference)
From page 434...
... The analytic techniques that can be used in assessing generational health outcomes include epidemiologic studies and experiments with animal and cellular models; these techniques are briefly described below. It is essential that the analysis include certain critical elements: proper adjustments for confounders; consideration of mediators and modifiers; identification of appropriate comparison groups; timeliness of the analysis and its reporting; and making the data used in the analysis accessible to outside researchers for their evaluation and further analysis.
From page 435...
... CHEAR's goals are to provide researchers with tools to expand the number of studies in children that include environmental exposure analysis, to implement the exposome concept in children's health studies, to create a public resource of children's exposures across the country, and to develop data and metadata standards for the environmental health sciences community. To accomplish these goals, CHEAR has three units: • The National Exposure Assessment Laboratory Network provides access to state-of the-art infrastructure for the analysis of biological samples as well as for understanding the biological responses associated with those exposures.
From page 436...
... To identify emerging health problems as well as to pinpoint the possible generational effects associated with various exposures, omics data generated from biospecimens can, in the context of the child's and the parents' health status, provide a resource with which to evaluate biomarkers of exposure and mechanisms of action and to develop a personalized response profile. The committee recognizes that the number of complete sets of data on children is likely to be limited, certainly in the early years of any HMRP.
From page 437...
... The size of the health monitoring effort, the amount of data collected on the specified populations (including comparison groups) , and the manner in which exposures are measured or estimated and health outcomes assessed will all contribute to determining the statistical methodology used for the epidemiologic research study, including sample size and power.
From page 438...
... Thus, it may be advisable to expand targeted sample sizes to compensate for exposure-classification issues, attrition of subjects by dropout, other losses to follow-up, and deaths of veterans and their descendants over the lengthy follow-up period. When planning a generational cohort study, there are additional considerations for power calculations that will need to be taken into account.
From page 439...
... Selection Bias As noted in Chapter 2 and in the section on Sampling of Study Populations earlier in this chapter, bias can result when study participants are selected in such a way that they do not represent the target population or if the probability of selection is related to exposure or disease status. This may be due to a poor definition of the eligible population or a failure to obtain a random sample.
From page 440...
... Information on mediators can be highly informative and can provide key information about the mechanisms involved in a given exposure-outcome association, especially in the context of generational health effects. However, limitations in the power of the analysis or in the data can make it difficult to detect mediators.
From page 441...
... The complexity of assessing mixtures, particularly poorly defined mixtures such as combustion products and their implications for epidemiologic studies of veterans was discussed in the IOM report on the long-term health effects of exposure to burn pits (IOM, 2011)
From page 442...
... These elements may be perceived as establishing a contemporary gold standard for answering questions about generation health effects. But the committee realizes that time and resources are finite, and while it may be possible to implement parts of the proposed health monitoring effort and hypothesis-driven epidemiologic studies, it may be more feasible and expedient to leverage ongoing programs such as the VA MVP.
From page 443...
... . Women are also asked about the birth weight of their first child, but no other data are gathered on the health status of the veterans' children.4 The only biological specimen that is collected is a blood sample that is processed into plasma, buffy coat, and DNA.
From page 444...
... Because the MVP records can be linked to deployment history and other military exposures, adopting the committee's recommendation to include enhanced exposure data collected during military service in a veteran's ILER would allow researchers to conduct nested case-control studies on, for example, the prevalence of a reproductive health outcome in veterans. Millennium Cohort In response to concerns about the health effects of deployments following the 1990–1991 Gulf War, Congress and IOM recommended that DoD conduct prospective epidemiological research to evaluate the impact of military exposures, including deployment, on the long-term health outcomes of veterans.
From page 445...
... To enhance the value of the Family Study for investigating generational health effects, the committee has several suggestions. First, it would be advantageous to have MilCo data link with other resources, 6  See http://www.familycohort.org/whatsnew (accessed May 10, 2018)
From page 446...
... DoD Birth and Infant Health Registry In response to the growing number of women on active duty and the diverse hazardous exposures associated with military service, DoD created the Birth and Infant Health registry in 1998, housed at the Naval Health Research Center in San Diego, to address women's reproductive health concerns, primarily birth defects. The registry collects comprehensive health care data on live births and infant health outcomes through the first year of life for infants born to TRICARE beneficiaries.
From page 447...
... In addition, they also demonstrate the many advantages and challenges faced by VA and other researchers when studying cohorts of veterans. They include • The National Health Survey of Gulf War Era Veterans and Their Families compares the mental and physical health status of a cohort of 15,000 Gulf War veterans from each branch of the military, including active-duty, reserve, and National Guard, with 15,000 of their nondeployed military peers.
From page 448...
... o Integrated Biosurveillance supports many worldwide biosurveillance and public health activities to improve force health protection.  • The Air Force Health Study, begun in 1979, was a longitudinal, prospective cohort study of more than 2,700 men who had participated in Operation Ranch Hand, the wartime herbicide spraying in Vietnam. Participants were followed for approximately 20 years, and they received up to six intensive physical examinations that included clinical measurements and observations, the collection of serum and other biological samples, and responses to questionnaires addressing health, lifestyle, socioeconomic status, employment, families and offspring, and potential sources of environmental exposures (Styka and Butler, 2015)
From page 449...
... Collaboration and Coordination The development and implementation of an HMRP to assess generational health effects in veterans and their descendants will require the joint efforts of a number of governmental and nongovernmental organizations. Although the statutory language in P.L.
From page 450...
... In P.L. 114-315, Section 633, Congress called on the Secretary of VA to establish an "Advisory Board On Research Relating To Health Conditions Of Descendants Of Veterans With Toxic Exposure While Serving In The Armed Forces." The Advisory Board is to "advise the Secretary in the selection of a research entity or entities under section 634, advise such entity or entities in conducting research under such section, and advise the Secretary with respect to the activities of such entity or entities under such section." The committee is to be composed of 13 members with expertise in birth defects, developmental disabilities, epigenetics, public health, reproduction, environmental exposure assessment, the science of toxic substances, and medical and research ethics.
From page 451...
... In addition, the overall study results should be regularly reported to participants, and the best vehicle for this report should be discussed with participant groups. The return of results is governed by well-established principles of ethical conduct in research, and some of these key elements are discussed below within the context of the proposed HMRP to evaluate reproductive and generational health effects.
From page 452...
... For example, participants in the National Children's Study felt pride in identifying themselves as part of the study cohort, and their interest was encouraged with such meaningful incentives from the researchers as networking, priority newsletters, and the occasional special event that prompted group recognition of the participants' continuation in the program. The Nurses' Health Study Growing Up Today Study (GUTS)
From page 453...
... As new sampling techniques and instruments become available for environmental toxicants, it may be advantageous to collect new or different types of information on deployment exposures. As the science of omics advances, it may become easier to identify biomarkers of exposure or biomarkers of effect and susceptibility in both veterans and their descendants.
From page 454...
... If results, particularly those for individuals, are to be provided to participants, they should be presented in a manner that promotes the health of the recipient. Providing results to individual participants may be difficult for the proposed HMRP, given the need for proxy consents for studies across multiple generations and the fact that much of the research to be conducted is being developed upon a very limited database that may not allow for a clear explanation of risks and benefits for participants.
From page 455...
... SUMMARY Designing, implementing, maintaining, and evaluating a program to conduct research to identify current or possible health effects in veterans' descendants is a substantial task, but many new technologies and methods are available to facilitate such a program, and the committee believes that it is an important undertaking. Understanding the possible generational health effects that may result from
From page 456...
... By building on existing health monitoring and epidemiologic research programs such as the DoD MilCo and the VA MVP, and taking advantage of access to databases such as the DoD Serum Repository and the DoD Birth and Infant Health Registry, it should be possible to reduce costs, expedite data collection, and provide access to already-engaged study populations. An HMRP with epidemiologic studies will require efficient program management and access to a variety of resources.
From page 457...
... A coordinated health monitoring system is needed to address these important questions. This HMRP will integrate and expand existing and future information across the multiple levels of decision making in order to generate timely and actionable knowledge for individual veterans and their children, VA, DoD, and Congress.
From page 458...
... 2008. Epidemiologic studies of veterans exposed to depleted uranium.
From page 459...
... 2016. Health study of Gulf War era veterans.


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