10
Future Use of the AH&OBP Registry
The congressional mandate (PL 112-260) that led to the creation of the Airborne Hazards and Open Burn Pit (AH&OBP) Registry was based on a sincere and well-justified desire to respond to the health care needs and concerns of veterans, particularly those who were deployed to the Southwest Asia theater. There is no doubt that many of those veterans and service members were exposed to substantial levels of airborne hazards, with one of the most distinctive and poorly understood being the emissions from open burn pits for military waste disposal. The committee was not asked to determine the most appropriate or effective response from the Department of Veterans Affairs (VA) regarding the potential health impacts of these exposures, but rather to assess whether the AH&OPB Registry is an effective approach to responding to those concerns.
The committee recognizes that the creation of the AH&OBP Registry was a large undertaking that required substantial time and effort from VA and that VA faced significant challenges in responding to the congressional goals and timeline for establishing the AH&OBP Registry, a difficult task to fully attain even under ideal circumstances. The committee’s reassessment of the AH&OBP Registry took into account the many logistical difficulties inherent in VA’s efforts, and it used the available information and data to determine whether the AH&OBP Registry adequately meets the primary functions for which it was intended and whether it is likely to do so if it is continued into the future. The committee focused its reassessment on the overall design and operation of the registry, rather than assessing the registry questionnaire itself, to determine whether—after nearly 7 years of operation—it has served the purposes for which it was intended, which are:
- to support etiologic (causal relationships) research (Chapter 5),
- to perform population health surveillance (Chapter 6),
- to improve clinical care (Chapter 7),
- to support VA policies and processes (Chapter 8), and
- to communicate with veterans, health care providers, and other stakeholders (Chapter 9).
The committee assessed whether the AH&OBP Registry’s ability to achieve these purposes would be enhanced by continuing to collect data and whether with limited, feasible modifications it could meet the criteria to fulfill those functions if it currently does not. The dividing line between modest refinements versus a new and fundamentally different AH&OBP Registry is somewhat arbitrary. However, the committee assumed that the essential features of the registry such as voluntary enrollment, reliance on self-reported exposure and health outcome data,
and the ability to link the registry to other sources of exposure or health data would be sustained. The committee also examined alternative information sources that address one or more of the goals of the AH&OBP Registry to ascertain whether any of them (or a combination of them) could be considered as a potential replacement to fulfill that registry purpose should the AH&OBP Registry be closed or its functions be narrowed to those that it can perform.
In this chapter the committee presents its final observations, key findings and conclusions, and recommendations regarding each intended purpose of the AH&OBP Registry. Based on its assessment, the committee offers recommendations that would optimize the use of the AH&OBP Registry while also noting factors that should be considered for the end state of the AH&OBP Registry in its current form (as specifically requested in the Statement of Task). Where applicable for each purpose, the committee explores alternative sources that would be more effective than the AH&OBP Registry. The chapter ends with final overarching conclusions and recommendations.
USE FOR ETIOLOGIC RESEARCH
One of the congressional and VA goals of the AH&OBP Registry is to support research on the health effects caused by deployment-related exposures to airborne hazards, including burn pits; however, there is a chasm between the expectation that it will be used for research and the reality of what it can actually do. The AH&OBP Registry was assessed on its ability to fulfill six characteristics that the committee identified as necessary to use an exposure registry for etiologic research. These characteristics correspond to the standard methodologic concerns in observational epidemiologic studies, namely random error (i.e., chance variation), selection bias, exposure and health outcome measurement error, and confounding. These characteristics are not intended to serve as a checklist or scorecard, but rather as considerations most applicable for etiologic research on health effects of exposures to airborne hazards. Those characteristics are:
- a sufficient sample size for precise estimation (estimates that have minimal sampling variability) of causal effects;
- a representative sample of the population of interest;
- identification of an appropriate comparison population;
- an exposure assessment of adequate quality;
- a health outcome assessment of adequate quality; and
- identification of other contributing factors (that might be related to the exposure and the outcome that would distort their relationship).
The committee finds that the AH&OBP Registry does not exhibit several of the characteristics that are necessary for an exposure registry to be used for etiologic research, notably a representative sample of the eligible population, an appropriate comparison group, an adequate exposure assessment, and an adequate health outcome assessment.
The committee therefore concludes that AH&OBP Registry data are not appropriate for etiologic research. The registry has major design and data quality issues that cannot be overcome. Even substantial changes to the questionnaire would be insufficient to make the AH&OBP Registry appropriate for etiologic research of airborne hazards exposures and health outcomes.
The committee then considered whether other sources of information, including the Individual Longitudinal Exposure Record (ILER), the Millennium Cohort Study, the Gulf War Registry, and various epidemiologic studies, could contribute to informing etiologic research, as summarized below.
ILER
One of the goals of ILER is to provide researchers with greater access to hazard and exposure information that can facilitate the identification of research cohorts with verified location information and health outcomes.
ILER’s use as a tool for etiologic research depends on the extent to which it becomes part of a research platform that meets the six characteristics presented above. Such research applications, however, are only speculative at this time as ILER is not yet fully functional. Before ILER can be used for research purposes, well-designed validation studies comparing ILER exposure measures with exposure indicators of known accuracy will be most informative.
The committee finds that, when fully operational with linkages to DoD and VA health care data, ILER may have many of the characteristics necessary for prospective etiologic research to address some health concerns—a sufficient sample size for precise estimates, be representative of the eligible population, allow the identification of appropriate comparison groups, an exposure assessment of adequate quality, a health outcome assessment of adequate quality, and identification of other relevant and contributing factors.
As new capabilities are added and as validated exposure and health information becomes available, ILER could become a complementary tool in VA and DoD efforts to understand the health effects of military exposures, but at this time it should not be viewed as an alternative resource for conducting etiologic research to determine causal associations between exposures encountered during military service and health outcomes.
Millennium Cohort Study
The Millennium Cohort Study is an ongoing epidemiologic study of active-duty service members intended to assess the health of participants after they separate from the military. It offers a unique opportunity for etiologic research compared with many other studies of post-9/11 veterans because of its regular follow-up of participants through standardized surveys completed approximately every 3 years. The study captures post-9/11 service members and veterans with a range of deployment experiences, including subsets who have had exposure to burn pits or airborne hazards as well as those who have been deployed elsewhere or not deployed at all, making appropriate comparisons among service members and veterans possible.
The committee finds that the Millennium Cohort Study fulfills the six characteristics for conducting etiologic research on the general deployment-related health effects of post-9/11 service members and veterans—its intended purpose. The committee also finds that, with some modifications to the number and type of exposure questions the Millennium Cohort Study asks, it could capture the airborne hazards of interest in the AH&OBP Registry questionnaire, and it could be an improved resource for conducting etiologic research on airborne hazards exposures for post-9/11 veterans and service members.
In order to address AH&OBP Registry exposures of interest more effectively, the Millennium Cohort Study would need to expand the number and granularity of the exposure questions to properly assess the association between specific exposures (at a more granular level than country and date of deployment) and health outcomes. Although the data collection does not include a clinical or physical health examination, self-reported health outcomes can be linked to VA and DoD data sources, including ILER, which would make it possible to validate self-reported information and to link those self-reported outcomes to records of deployment, medical history, demographic information, and other key variables, which would improve the information available for etiologic research.
Gulf War Registry
The committee finds that the Gulf War Registry satisfies a few but not all of the characteristics necessary for an exposure registry to be used in etiologic research, and therefore it is not appropriate for use in etiologic research on airborne hazards exposures and health outcomes.
It has many of the same limitations as the AH&OBP Registry, including a self-selected population that is not representative of the eligible population and the use of self-reported exposure information. The Gulf War Registry has one advantage over the AH&OBP Registry in that a comprehensive health examination conducted by a VA
provider is required for participation. Participants are also offered diagnostic testing and specialty referrals as clinically indicated.
Epidemiologic Studies of Military and Veteran Populations
The AH&OBP Registry is not a substitute for epidemiologic research on the health effects of airborne hazards as it does not fulfill the necessary characteristics. There are ongoing DoD- and VA-funded studies that may offer alternative approaches to conducting etiologic research on airborne hazards—and on exposures to burn pits specifically—through creative or novel methods or data sources, and these may include mechanistic studies. Additionally large, validated studies, such as the Millennium Cohort Study, have a number of relevant strengths and could be adapted to address the exposures of concern.
If a new epidemiologic study were to be designed with the same goals as the AH&OBP Registry, it could focus on addressing the most salient exposures and collecting more detailed information on them. Furthermore, a new epidemiologic study could incorporate objective health outcome assessments, including the identification and collection of other relevant and contributing factors for exposure–health outcome relationships. For new studies to inform etiologic research, they would need to address the six characteristics listed above.
The committee recommends that VA support the conduct of epidemiologic studies to examine the associations between exposures to airborne hazards and open burn pits and health outcomes. The studies should be designed specifically to fulfill the characteristics needed for etiologic research—a sufficient sample size for precise estimates, a sample that is representative of the eligible population, identification of an appropriate comparison group, an exposure assessment of adequate quality, a health outcome assessment of adequate quality, and identification of other relevant and contributing factors.
The sampling design could target representative samples of the deployed population at specific times, apply novel methods for a retrospective assessment of airborne hazards exposures, and include more granularity of deployment- or military-service exposures than does the AH&OBP Registry questionnaire.
USE FOR POPULATION HEALTH SURVEILLANCE
In Chapter 6 the committee considered to what extent the AH&OBP Registry currently meets each of the four criteria of a population health surveillance system as adapted from the Centers for Disease Control and Prevention (CDC, 2012; German et al., 2001). The four criteria are:
- Decide on the overarching goals to address the prevalence or incidence of a potentially harmful exposure or occurrence of a disease in a defined population;
- Regularly collect, analyze, and interpret the data that are acquired to look for predefined “signals” or unexpected occurrences of outcomes or association patterns that would motivate some type of action;
- Disseminate data, results, and information to key audiences; and
- Seek to improve health as a result of the collection and dissemination of that information.
The committee finds that the AH&OBP Registry does not satisfy all four of the criteria necessary to conduct population health surveillance for service members and veterans potentially exposed to burn pits or other airborne hazards in the Southwest Asia theater.
Furthermore, given its fundamental design, the committee concludes that refinements or improvements will not allow the AH&OBP Registry to serve as a population health surveillance system.
The AH&OBP has an overarching goal to monitor veterans’ health as directed by public law. The AH&OBP Registry is unable to fulfill the second criterion because as it lacks regular data collection (the data for each registry
participant are collected only once,1 cannot be corrected or updated after the questionnaire is submitted, and the exposure questions are not granular); lacks regular data analysis (there is no appropriate comparison group, data sensitivity is poor, and data are not systematically analyzed but only summarized); and lacks regular data interpretation. Because of the way the exposure questions are worded and that most (98.5%) participants report at least one airborne hazard exposure, it is not possible to compare levels of exposure among participants. Frequent expansion of eligibility criteria has changed the population from which participants are drawn, making it more difficult to detect signals in health outcomes. The lack of longitudinal data makes it difficult to identify trends in the reported outcomes over time. VA only infrequently shares or disseminates descriptive data from and about the registry with key audiences through targeted notices and periodic reports published on VA’s website, and therefore the committee did not consider criterion 3 to be met. The impact of how (or if) the data collected by the AH&OBP Registry have been or could be used to improve the health of the population of service members and veterans who served in the Southwest Asia theater is unclear. The specialized programs of VA’s Airborne Hazards and Burn Pits Center of Excellence (AHBPCE) may be a form of or offer opportunities for health outcome monitoring for certain veterans that may improve some clinical care, but the committee does not consider this to be population health surveillance.
As the AH&OBP Registry did not meet the criteria for surveillance, the committee considered whether it could be used for simply monitoring health. The committee defined monitoring activities as data gathering without intended action or intervention, or to determine the prevalence of a health outcome in a selected population. To monitor in this sense implies a time component since health effects may be acute or chronic, immediate or latent, or develop, resolve, or change over time. The only way to monitor health is to periodically collect updated exposure and health information, which the registry does not currently permit. Continuing to allow new eligible individuals to enroll in the registry will not serve a monitoring function because the critical lack of participant follow-up will not be addressed. Moreover, VA informed the committee that “there are no immediate plans to follow up with the entire cohort with additional questions at this time” (VA, 2021a).
Therefore, the inability of the AH&OBP Registry to perform population health surveillance or to simply monitor health patterns over time leads the committee to conclude that it should not be promoted as being able to conduct either of these functions.
VA has the responsibility for implementing a population health surveillance system (as defined by PL 112-260) that meets, at a minimum, the four criteria discussed above and in Chapter 6. The committee considered several alternative sources of ongoing data collection that might serve as mechanisms for health surveillance of this population. ILER, as it was designed and intended to be implemented, may minimally meet three of the four criteria, although there are several factors that must be addressed for this to occur. Several features of ILER that make it unsuitable for conducting etiologic research on the health effects of burn pits and other airborne hazards exposures at present were described in detail in Chapter 5, and several of those factors continue to be relevant when considering ILER’s use for population health surveillance. For example, its available location information does not cover 1990–1991 Gulf War or Peacetime era deployments.
VA has stated that ILER is intended to serve as the “registry of the future” and that it will be used for surveillance activities (criterion 1, having overarching goals to address the prevalence or incidence of a potentially harmful exposure or occurrence of a disease in a defined population). By compiling information on location, exposures, and health from several DoD and VA sources, ILER could meet the second criteria of regularly collecting, analyzing, and interpreting data. Criterion 3—disseminating results with key audiences—could be met through communications channels as well as by individual clinicians sharing information with their service member or veteran patients. ILER will not necessarily meet the fourth criterion of improving health as a result of the collection and dissemination of that information unless some ancillary activities that respond to the health surveillance data are incorporated. Information on an individual’s exposures may assist a clinician in diagnosing and treating that individual, but this does not translate to improving health on a population level. Without meeting the fourth
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1 New eligible deployments and the nine associated exposure questions for each new deployment may be added after questionnaire submission beginning on March 29, 2022.
criterion, ILER may be able to conduct only health monitoring, not surveillance. The extent to which these criteria are met (or not) will ultimately depend on ILER’s completion and full capabilities.
The committee finds that ILER could serve as a component of a future population health surveillance system for airborne hazards. However, ILER is not fully functional at this time, it does not fulfill the committee’s four surveillance system criteria, and its already-identified limitations will prevent it from fulfilling that function for the AH&OBP Registry population, particularly those who were exposed prior to 2006.
Therefore, ILER has potential value for capturing some deployment-related exposures in the future, and for those who served in the armed forces after 2012 (the earliest time for which DoD clinical summary information is currently available) as a tool or component of a population health surveillance system, depending on its continued development and validation of the information it compiles. Information on exposures is primarily available beginning in 2006, and although the amount of exposure data may improve as additional reports are digitized or as information from other sources is made available for compilation, complete information on deployment exposures and at the individual level will still not be available. The impact of these information gaps will depend on the specific exposure of interest, but may be particularly problematic for burn pit exposures. As such, ILER is not and should not be looked to or promoted as a population health surveillance system for service members and veterans exposed to burn pits and airborne hazards before 2006. Not only are verified exposure locations needed, but a validated algorithm for differentiating exposure levels would also substantially improve the use of ILER for population health surveillance. ILER could be a low-cost, rapid mechanism to conduct health surveillance of service members and veterans with burn pit and airborne hazard exposures on an ongoing basis, including detecting health conditions with long latency periods. VA’s ability to conduct population health surveillance using ILER will hinge on its actual completion, the quality of the source data, and whether it is possible to reliably define groups of exposed service members for follow-up, particularly those who are eligible for and use VA health care.
USE TO IMPROVE CLINICAL CARE
VA has stated that one of the goals of the AH&OBP Registry is to improve clinical care for veterans and service members who were deployed to the Southwest Asia theater. The registry website states, “Completing the questionnaire can also help you proactively identify health concerns, discuss them with your health care provider, and get follow-up care” (VA, 2021c).
Veterans who served in the Southwest Asia theater and who were discharged less than 5 years previously are eligible for VA health care for 5 years after separation from the military (PL 117-168 extends that eligibility to 10 years) and by eligibility for a priority group after that time. These restrictions on eligibility for VA health care mean that a veteran’s participation in the AH&OBP Registry does not necessarily result in his or her access to that care. If a veteran has a health condition that may be related to exposure to airborne hazards or burn pits, such as the recent presumptions for service connection for several health conditions associated with exposure to fine particulate matter (i.e., asthma, rhinitis, sinusitis, nine cancers, and those specified by public law), and he or she is granted service connected disability, he or she would qualify for VA health care. Veterans who are not otherwise eligible for VA health care must seek care outside the Veterans Health Administration (VHA). Completing and submitting the AH&OBP Registry questionnaire and electing to receive the optional health evaluation does not directly affect a veteran’s care or assignment to a priority group.
The committee finds that there are substantial issues with using the AH&OBP Registry to improve clinical care: For a veteran to receive the optional health evaluation, he or she must first complete the lengthy, online self-assessment questionnaire, which captures only a select set of health outcomes, and once the participant has expressed an interest in having a health evaluation, the responsibility for scheduling the evaluation with the VA environmental health coordinator rests entirely on the veteran, as does follow-up for any referrals the participant may receive.
VA’s Health Outcomes Military Exposures (HOME) told the VA Office of Inspector General (OIG) review team that it has a flagging system to could be used by environmental health staff at medical facilities to document outreach to interested veterans but that few facilities appear to use it. Some VA medical facilities, however, are proactive and do reach out to veterans who are interested in having an evaluation to schedule one. VA OIG also noted that many veterans do not realize that, based on the wording of the questionnaire and the accompanying participant letter, the onus for scheduling the evaluation is on the registry participant (VA OIG, 2022). To partially address the confusion expressed by some veterans about whether or not they must contact VA to schedule the health evaluation, VA has recently begun alerting the environmental health coordinator that a participant (unnamed) has indicated an interest in having the health evaluation.
The evaluation is to be conducted within 90 days of the participant requesting one but the VA OIG review team also noted that there was confusion among VA staff as to when the 90-day timeline began.
The committee recommends that VA should simplify the scheduling of the registry’s optional health evaluation by having the VA environmental health coordinator proactively reach out to a veteran when notified of his or her interest via completion of the AH&OBP Registry questionnaire.
At present, only about 10% of registry participants who have indicated an interest in receiving a health evaluation have had one, although about 50% of participants have expressed such an interest. VA acknowledges that it needs to improve the number of health evaluations that are completed. VA OIG reported a steadily growing backlog of uncompleted evaluations and noted that an average of 4 years had elapsed between a veteran requesting an evaluation and receiving one. Medical facilities that have been proactive about contacting veterans to schedule the evaluation had a higher completion rate than many of those that were not proactive.
The committee recommends that in order for the registry to fulfill its stated purpose of improving clinical care, VA should expedite the receipt of the optional health evaluation for those registry participants who request one.
Although the health evaluation does not necessarily improve a veteran’s access to health care, it does provide an opportunity for service members and veterans to speak with knowledgeable health care providers who are trained to understand the deployment exposures that service members experienced, a benefit that is generally not available in civilian health care. The health evaluation also is an opportunity for VA health care providers to perform physical examinations on participants, advise them about health risks, and recommend medical screening and follow-up activities, regardless of the participant’s eligibility for VA health care. The VA OIG report noted that veterans who use VET-HOME, a call center that VA expects to have operational by October 2022, will be expected to have a telehealth health evaluation, followed by an in-person physical examination if deemed necessary by the clinician; if veterans want an initial in-person evaluation they will need to contact their local VA environmental health coordinator (VA OIG, 2022). A health care provider may also ask about a veteran’s unmet health needs during the health evaluation to address those needs directly or refer the participant as appropriate. VA has worked to standardize the health evaluation by implementing the AHOBPR Clinical Template with accompanying guidance on its use; the template is available electronically to VHA clinicians.
The committee recommends that the Airborne Hazards and Open Burn Pit Registry Clinical Template for registry health evaluations and the accompanying clinical guidance be modified to ensure that the VA clinician conducting the evaluation discusses the registry participant’s military deployment and exposure history with them and documents the information in the participant’s electronic health record.
Veterans who complete and submit the questionnaire can save and print out their responses and, for those who have received a health evaluation, receive a summary of the results of that evaluation. These materials can be shared with the veterans’ health care providers, both within and outside the VA, to discuss their health care needs, diagnoses, and if appropriate treatment. The AH&OBP Registry questionnaire printout for health care providers is not summarized in a concise, clinically relevant format as was recommended by the initial assessment committee.
At the conclusion of the health evaluation, those enrolled in VHA will also have a note about any referrals included in their electronic health record. An electronic health record is established for all registry participants who receive a health evaluation regardless of whether they qualify for VHA enrollment. Information from the health evaluation is not used to confirm or correct participants’ responses to the questionnaire.
The committee recommends that at the end of the health evaluation, VA should proactively schedule any necessary referrals with the appropriate VA providers for veterans enrolled in VHA to ensure that they receive the appropriate diagnoses and treatments. The committee recognizes that this proactive scheduling will not be possible for veterans who receive health care outside of VA.
The committee considered whether the AH&OBP Registry optional health evaluation may serve as an entry point into VA health care for veterans who are eligible to enroll in VHA. Although no data were available to the committee to describe trends in VA health care enrollment following registry enrollment or receiving the health evaluation, it appears that participating in the registry and, to a lesser extent, receiving the evaluation may increase subsequent VHA use, although the committee acknowledges that several other factors may also affect VHA use subsequent to AH&OBP Registry participation. Thus, joining the AH&OBP Registry might be an incentive for eligible registry participants to seek care at VHA if already enrolled and to join VHA if they are eligible and have not already done so. The health evaluation may provide an entry to VHA for some eligible veterans, but for veterans who are not eligible for VA health care, the benefits of participating in the registry are less tangible.
The committee finds that participation in the registry may encourage veterans and service members to request a health evaluation and to seek follow-up care within or outside of VA for any health conditions identified by the evaluation.
The committee concludes that the AH&OBP Registry health evaluation may enhance a veteran’s knowledge of his or her health status, but it does not improve a veteran’s access to or continuity of care.
AHBPCE is taking the lead on developing clinical guidance on best practices for conducting the health evaluations via its AHBPCE IQuEST (Center for Innovations in Quality, Effectiveness and Safety) Military Exposure Surveillance (AIMES) collaborative. Through the Post-Deployment Cardiopulmonary Exposure Network (PDCEN) collaborative, AHBPCE is also conducting additional in-depth health evaluations for a small, select number of veterans with specific serious respiratory diseases (e.g., chronic obstructive pulmonary disease) to study optimal treatments. The committee did not receive any information indicating whether AHBPCE’s efforts such as AIMES and PDCEN have resulted in improved clinical care for veterans or service members with those selected respiratory conditions. Improving clinical care for registry participants will depend on the availability and knowledge of the VA environmental health care providers and on the translation of research on military exposures and health outcomes into clinical practice.
USE FOR SUPPORTING VA POLICIES AND PROCESSES
VA does not use the AH&OPB Registry for internal policy decisions because, it states, the program is relatively new, although the committee notes that the registry has been in operation for over 7 years. VA indicates that the registry is not used to inform policy beyond standardization of registry procedures such as for VHA Directive 1307, which directs administrative and clinical procedures and processes for the registry health evaluation. (VHA Directive 1307 was rescinded in March 2022 and replaced with VHA Directive 1308, which is not specific to the AH&OBP Registry.) A registry that can be used to meet ambitious research and policy goals or to inform administrative processes, such as claims adjudication, requires a greater initial investment than one that is intended to serve as a roster for education or communication purposes.
For example, the use of registry data, particularly for the health evaluation component, may help identify logistic bottlenecks in clinical care. Reducing the backlog of over 100,000 registry participants waiting for
AH&OBP Registry health evaluations is a focus of a recent report from the VA’s Office of Inspector General (VA OIG, 2022). Linking registry data to VA medical centers with long wait times could make it possible to track the facility’s progress toward conducting health evaluations within 90 days of a participant’s request for one. The same data could be used in budgeting and financial forecasting related to the registry program. For example, increasing clinical capacity to perform the evaluations would have budgetary implications, possibly requiring the recruiting or training of additional staff.
VA has not used registry data to inform its policies to date, but the committee finds that VA could use AH&OBP Registry data to inform program development and budgeting processes related to the registry, especially those relating to the registry health evaluation.
AH&OBP Registry data also could be used to identify health concerns among veterans, allowing VA to make these concerns policy priorities. These concerns might influence those developing a research agenda to address pressing knowledge gaps. For example, if there is a signal or indication that participants are reporting a rare outcome, such as idiopathic pulmonary fibrosis, more frequently than might be expected, this outcome might become a research priority.
Although supporting the claims process for benefits is one of VA’s stated goals for the AH&OBP Registry, the Veterans Benefits Administration’s claims review process is completely separate from veterans’ registry participation. As the registry questionnaire captures information about specific locations, dates, exposures, and self-reported health outcomes, a printout of the participant’s responses may be one document submitted by a veteran in support of a disability claim, as may the results of the health evaluation. It must be emphasized that the registry health evaluation does not replace the disability rating examination, which has specific criteria that may lead to different results than the health evaluation. Although VA has clearly stated that participation in the AH&OBP Registry is separate from the benefit claims process, even implying a relationship between registry participation and the claims process may create confusion among veterans.
The committee finds that the registry questionnaire and health evaluation summary are, at best, supportive evidence for the claims process.
The committee concludes that VA messages that overstate, even slightly, the relationship between the registry and the claims process may cause confusion among veterans and thus be counterproductive.
Finally, VA has informed registry participants that the information they provided helped inform VA’s determination of presumptive service connections between deployment exposures to fine particulate matter in the Southwest Asia theater and asthma, rhinitis, and sinusitis. AH&OBP Registry data on respiratory conditions may have affirmed, or at least did not contradict, the presumptive connections in question. To say that they informed the policy, however, may be an overstatement. Registry data were not used to support the service-connected presumption decision for nine rare respiratory cancers (Federal Register, 2022).
The expectation that the AH&OBP Registry data might be needed to inform decisions about presumptive connections may have changed with the August 2022 passage of PL 117-168. The act substantially expanded the list of presumptive conditions for which veterans or their survivors can access health care or disability compensation. It also specifically mentions presumptive connections between military service and 11 respiratory conditions, as well as most cancers, and acknowledges the possibility of expanding the list to other diseases based on established associations with airborne hazards.
USE FOR SUPPORTING COMMUNICATIONS AND OUTREACH
PL 112-260 § 201 requires that VA “(C) develop a public information campaign to inform eligible individuals about the open burn pit registry, including how to register and the benefits of registering; and (D) periodically notify eligible individuals of significant developments in the study and treatment of conditions associated with exposure to toxic airborne chemicals and fumes caused by open burn pits.” Although VA has made efforts to meet
the mandate to inform eligible individuals about the registry, it has not, with some exceptions, been proactive in informing eligible individuals about research developments, the treatment of conditions associated with exposure to airborne hazards, or about new programs and benefits designed for them.
The HOME broad communication plan, which covers all six of VA’s exposure registries, contains many of the elements of an effective communication plan (e.g., establishing communication objectives, identifying target audiences and key messages, use of a variety of communication channels, metrics to assess effectiveness), but it provides few details on specific communication channels, purpose, metrics, or a timeline for dissemination of information. VHA is in the process of establishing the VET-HOME call center to assist with scheduling and coordinating the AH&OBP Registry health evaluations and to answer veterans and health provider questions about military exposures. VET-HOME is one communication channel in the broad communication plan; it is expected to be operational by October 2022 (VA OIG, 2022).
VA has not provided options for registry participants or potential participants to communicate their concerns, experiences, and questions to VA other than by completing and submitting the AH&OBP Registry questionnaire. Thus, not only should VA inform current and prospective participants about the registry and the benefits of enrolling in it (as required by law), but participants also need a mechanism to inform VA about their concerns as well.
Some exposure registries, such as the World Trade Center Health Registry, have comprehensive communication strategies and structures to reach and maintain contact with their target audiences over the lifespan of the registry. Registries may have periodic scheduled communication activities from registry owners to inform participants and other interested stakeholders about research, benefits, or other relevant information. However, it must be noted that a registry is not itself a study or evidence or a social media platform, nor is it a forum for communication among participants (Schoch-Spana, 2020).
A registry’s communication and dissemination activities can reach a large audience and be of value to participants, for example, by alerting them to new service connections or health findings. VA communication activities include the dissemination of information and educational materials to registry participants, other stakeholders, and health care providers, but the value of these materials to registry participants and others is unclear. VA has made no attempt, other than a qualitative assessment of a few registry participants and nonparticipants, to determine whether its communication products and outreach activities are informative for the intended audiences (VA, 2021d). The brief qualitative assessment did result in new and revised communication products, but no further efforts have been made to ascertain whether the products reached the appropriate audiences and were of value to them.
The committee finds that feedback on the questionnaire, while important, does not address whether any new communication materials or outreach activities reach the target audiences or whether the materials and activities provide value to registry participants and other veterans and service members.
To date over 317,000 veterans and service members have participated in the AH&OBP Registry with the expectation that the information they provide will be used for research on the health effects associated with deployment exposures, which, as described in Chapter 5, the registry cannot do. VA’s initial communication strategy focused on promoting participation in the registry, but as participation has grown, the communication strategy should have evolved to focus less on recruiting new participants and more on providing information that would be of value to current participants. HOME has indicated that it continues to determine the success of its communication and outreach activities by the number of new registry participants each month (VA, 2022). VA has provided little information to registry participants that indicates how registry data has been used to benefit veterans, whether registry participants or not. The VA public health webpages contain a variety of information about specific deployment exposures, including to burn pits and other airborne hazards, but what, if any, information has been derived from registry data is not clear. Nor does it appear that any such information is sent directly to registry participants on a regular basis, either electronically or by the U.S. Postal Service. VA does send automated or ad hoc communications to registry participants using selected filters or criteria as appropriate for a particular communication, such as the email sent to participants to inform them of the new presumptive service connections
for three respiratory conditions, a targeted message to questionnaire noncompleters to remind them to do so, and a message about COVID-19.
The committee concludes that such notifications could be one of the primary benefits of registry participation.
VA has outreach activities for VA health care providers, including information on the registry’s website, occasional educational webinars, and directives. Many of these materials are publicly available on either VA or DoD websites and thus are accessible to any provider.
The committee concludes that both VA and DoD have made good efforts to reach and educate their health care providers on the AH&OBP Registry, how to talk with their patients about joining the registry, and how to conduct health evaluations.
Many veterans who participate in VA’s registry programs provide their contact information so that they may be kept up to date about the latest scientific findings on deployment exposures and associated health outcomes. Periodically, VA sends emails to participants asking them to update their contact information, but although participants can change that information, they cannot select more than one method (e.g., electronic, U.S. mail, other) of receiving information about the registry or change the delivery method after submitting the questionnaire.
The committee recommends that VA periodically assess whether its communications and outreach materials and activities provide value to registry participants and health care providers. This assessment may result in the expansion of the Health Outcomes Military Exposures communication strategy to capture feedback from potential or existing registry participants regarding their concerns or questions about the registry, their exposures to airborne hazards, and their health outcomes. A bidirectional communication strategy should include both written and verbal communications among VA experts, participants, and other interested stakeholders. Communication channels other than the questionnaire that might be used include hardcopy mailed materials, virtual meetings, webinars, workshops, town halls, and a comment field on the registry’s website.
Although the AH&OBP Registry cannot be used to perform etiologic research, cannot be used to conduct population health surveillance or monitoring, does not inform VA policies or processes, and has only a tenuous ability to improve clinical care, there are other functions that the registry might be better suited to accomplish, including documenting the experience of participants and creating a roster of individuals who might benefit from specific communications or activities. There is value in creating a roster of concerned individuals so that VA can disseminate new health and benefits information to them.
The initial assessment committee and this reassessment committee conclude that the AH&OBP Registry is primarily useful as a mechanism to create a roster of concerned individuals and to provide bidirectional communications with registry participants.
However, requiring that registry participants complete a lengthy questionnaire is neither necessary nor recommended for this function.
The committee recommends that the AH&OBP Registry serve as a roster of interested service members and veterans to provide a vehicle for them to express their concerns regarding exposure to burn pits and other airborne hazards and potential health outcomes.
INTEGRATED ASSESSMENT OF THE AH&OBP REGISTRY
If there were sources of information or systems currently in place that could achieve the stated purposes of the AH&OBP Registry, then these sources would obviate the need for the registry. The committee carefully considered sources that are currently available and those that are likely to become available in the near future, such as ILER. The committee found that no single source or combination of sources currently exists that could adequately fulfill the five intended purposes of the AH&OBP Registry. Therefore, based on its assessment, the committee offers recommendations that would optimize the use of the AH&OBP Registry by refining its operation to include only those purposes that could be achieved in its current state or with minimal, feasible changes.
Although there is currently no single source available for addressing all of the AH&OBP Registry’s five purposes, the question remains whether the AH&OBP Registry itself is making a meaningful contribution to any of the purposes. There is an important distinction between making a limited contribution as the best available resource and making no contribution regardless of whether alternative approaches are available. The committee considered each of the AH&OBP Registry’s contributions both in absolute terms and relative to alternative sources that are currently or could become available in the near future.
The health problems experienced by so many service members and veterans who have deployed to Southwest Asia are real and concerning and need to be addressed; however, the AH&OBP Registry is not the right mechanism or solution to properly address these issues. Ultimately, the decision regarding the disposition of the AH&OBP Registry will take congressional and VA action since both will need to consider how to balance the needs of their constituencies with the limited ability of the AH&OBP Registry to perform what has been asked of it. The committee does not consider these types of policy decisions in its assessment, and instead it focuses on the objective and scientific aspects of the registry, which is only one contributor to policy decisions. Given the significant financial cost2 of maintaining the registry and the burden placed on participating individuals relative to what appear to be limited one-time or continuing benefits of that participation, it is imperative that the goals and functions of the registry be refined to be attainable and to provide a valuable contribution to this population of concerned service members and veterans.
The VA OIG recently released a report focused on the optional health evaluation component of the AH&OBP Registry. Several findings from that report have been cited in the previous chapters, particularly chapters 7, 8, and 9. The VA OIG made seven recommendations to the under secretary for health regarding actions to be taken to improve the AH&OBP Registry and the optional health evaluation process (see Box 10-1). Not all the areas covered by the seven recommendations were within the scope of the reassessment committee’s Statement of Task, but all seven recommendations are shown for completeness. The deputy under secretary for health and the program office concurred with these recommendations and submitted an action plan that responds to each recommendation (VA OIG, 2022).
As directed in its Statement of Task, the committee considered the point at which the AH&OBP Registry or any registry that is based on self-reported information would complete its intended purpose and what an end state for the registry might look like. Any policy decision to maintain, expand, or close the AH&OBP Registry will necessarily be based on a range of considerations, including congressional interest and action, VA’s priorities, costs and budget, competing priorities, and value to veterans and stakeholders. The relative weights of each of those considerations and priorities are not necessarily equal. Because these priorities may change over time, the committee does not make a recommendation about the specific end state of this registry. However, the committee addressed the critical question of whether the AH&OBP Registry should be sustained in its current state or be modified to continue to accrue additional data as a resource for improving the understanding of health effects of airborne hazards. This involved assessing both what it has contributed to achieving its stated purposes since its national launch in June 2014 and, more importantly, whether sustained data collection and analysis will make future contributions.
Maintaining the AH&OBP Registry in its current state means that new participants will continue to enroll, so a key determinant is whether the addition of these future enrollees will be helpful in addressing the broader concerns
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2 Including over $1 million a year in information technology, over $3.3 million a year in health evaluations and associated tests, and over $1 million in contacts for communication and outreach, as well as operational and development costs not provided to the committee (see Chapter 3).
of service members and veterans or, specifically, those of the new enrollees. Based on the findings related to the registry’s use for performing etiologic research and population health surveillance specifically, the addition of more enrollees and participants will still not meet the necessary characteristics or minimum criteria, respectively, to perform either of these functions. Minor changes to the questionnaire or registry platform might improve the quality of some of the collected data or other facets of it, but these changes would still not enable the registry to fulfill all of Congress’s or VA’s purposes.
Therefore, the committee concludes that the stated registry purposes of “research about potential health effects of airborne hazards exposures” (VA, 2021c) and conducting population health surveillance are unattainable, that data collection to meet these purposes is not helpful, and that efforts to address these important functions could be pursued in other, more effective ways.
By stripping away those two unattainable goals, the resources that support the registry can be better directed to the two purposes that it can affect and contribute to in a meaningful way with much less burden on registry participants: health care, especially for those enrolled in VHA, and communications. By changing the focus of the registry to these two purposes, the AH&OBP Registry could be used to inform VA policies or procedures for the registry, such as better clinical guidance through its directives.
Therefore, given the two purposes that the registry could achieve in the future, the committee recommends that VA initiate a new phase for the AH&OBP Registry. Implementing this new phase will require thoughtful and deliberate efforts and careful alignment of the narrowed functions with the data collection process.
Without being prescriptive of what exactly this new phase of the registry should be, the committee offers general areas of focus that can be readily optimized, given the design and structure of the current AH&OBP
Registry. One of the key considerations for this new phase of the AH&OBP Registry will be how the hundreds of thousands of veterans who have already invested the considerable time and effort to participate would be affected by changes to it. Their motivation to participate often is a result of personal experience and priorities, with those who have health problems—particularly problems potentially attributed to the exposures of interest—being more likely to enroll than those individuals who do not experience such outcomes. The enrollees (participants as well as those who have begun but not completed the questionnaire) provide a unique and valuable roster of interested and concerned individuals, and that contribution will not be lost by refocusing the registry to be primarily a communications and a one-time health evaluation platform for current and future participants. The registry health evaluation, which would continue to be offered, is an opportunity for participants to access clinical subject-matter experts who can provide basic and specialized longitudinal health care services designed to address participants’ exposure concerns. In fact, to the extent that the registry can evolve into the primary national resource for engaging a population of interested and concerned veterans and facilitating their receipt of optimal health care—for example, through standardized health evaluations with knowledgeable health care providers who are trained to understand the deployment exposures that service members’ experienced, advise them on health risks, and recommend medical screening and follow-up activities—it will provide important information on their experiences to VA and Congress. It can also provide a forum for the collective voice of concerned veterans, as it will document and substantiate the efforts of those who have chosen to participate.
In considering the future for the AH&OBP Registry, it is clear that communication should have a central role. At a minimum, those who take the time to enroll have indicated their interest or concern with airborne hazards exposures in relation to their current or future health, and that alone warrants an appropriate response on the part of the registry operators. The large number (over 400,000) of enrolled individuals—not just those who have completed and submitted the questionnaire, but those who have also begun but not completed it—constitutes the largest identified roster of such individuals. In considering the continued accrual of participants in the future, the more who enroll, the more will be reached via different communication mechanisms. This would also align with VA and congressional priorities of encouraging maximum participation and would not be adversely affected by expanding eligible countries or time periods of service. Finally, the need for bidirectional communication is clear—for the veterans to “speak” collectively to VA and for VA in turn to convey information to concerned veterans.
Based on the committee’s careful assessment of the registry and consideration of each of its intended functions as described in detail in chapters 5–9 and above, the committee recommends that the AH&OBP Registry be ended in its current form as its stated purposes have largely been to support research and population health surveillance, neither of which it can do. This new phase would build on key information from the first 7 years of registry operations and would be developed and implemented to optimize the registry to be a user-friendly, efficient, and effective resource to provide two-way communication between participants and VA. Additionally, VA should ensure that this new phase provides information to enhance health care access and quality.
The effort and resources (including budgetary resources) devoted to maintaining the AH&OBP Registry in its current form would be more usefully directed toward using and refining alternative mechanisms for etiologic research and population health surveillance, with sufficient resources remaining to support a greatly streamlined, time- and cost-efficient mechanism for generating a roster of individuals who are interested in or concerned about the health effects of airborne hazards exposures.
The committee further recommends that the information generated by the AH&OBP Registry be presented in a manner that is helpful for informing the general public, Congress, and the media about participants’ collective concerns.
This is consistent with one of the foremost conclusions of the initial assessment committee—that, similar to other VA post-deployment health registries, the AH&OBP Registry is primarily useful as a mechanism to create a roster of concerned individuals and provide outreach and health risk communication to them.
As discussed in Chapter 9, providing a forum for service members and veterans to document their experience is an important function that the registry can readily perform. The new phase of the registry should be guided by the achievable functions of communication, improvements in clinical care, and registry-related policy. These guiding functions should not include etiologic research or population health surveillance.
Therefore, the committee recommends that the current self-assessment questionnaire be replaced with one that is shorter, more efficient, user friendly, and limited in scope to collect only information that can be used to support communication or health care.
This would be a major undertaking that would require careful and intentional thought, as well as the involvement of experts in survey design and development who would consider the characteristics of the population of interest (educational and cultural background, incentives and disincentives to participate, and so forth) and the features of web-based survey design and data collection, including IT constructs that facilitate data collection across multiple types of devices, including mobile phones. Through these redefined priorities, the registry may become a more useful and efficient tool for participants to speak collectively to VA about their deployment exposures and health concerns. This large population of concerned veterans is an important constituency that could be provided with new information as it develops (such as on the diagnosis of or treatment for specific conditions or research results), guidance on how to obtain the health care that they need through VA, and other information or resources. To fulfill these purposes, discussions with veterans and service members, health care providers, and survey methodologists will be needed. The new data collection instrument for this new phase of the registry would be developed based on several key principles:
- The new instrument should be short, simplified, efficient, effective, and user-friendly. It should include free-text entry fields to allow participants to express concerns not otherwise captured. Each item included in the new instrument should have a clear plan for its use to support at least one of the achievable functions and veterans’ concerns, and that plan should be developed before the instrument is implemented.
- The content of the new instrument should be pilot-tested with veteran participants using multiple platforms (e.g., computers, tablets, and mobile phones) and should include feedback on whether the instrument addresses the participants’ concerns and minimizes respondent burden.
- The new instrument should continue to offer the opportunity for participants to receive a free health evaluation. For those who choose this opportunity, processes should be changed to make the health evaluation easier to schedule in a timely manner, and for VHA users there should be proactive scheduling of any necessary referrals with the appropriate VA providers to ensure that the participant receives the appropriate diagnoses and treatments.
- Registry data should be used to improve registry processes and inform related policies.
FINAL OBSERVATIONS
The committee’s Statement of Task specified several areas where the committee was to make recommendations based on its assessment of the evidence. Thus, the committee considered whether the information collected by the AH&OBP Registry is scientifically up-to-date and made recommendations to improve how the registry collects and maintains that information. The committee was also tasked with assessing “the most effective and prudent means of using the AH&OBP Registry or another system of records to provide information that translates into learning more about the conditions that are likely to result from exposure to open burn pits” and identifying alternate forms of health surveillance and research candidates should the AH&OBP Registry be closed. The committee considers each of these tasks below.
Is the AH&OBP Registry “current and scientifically up-to-date?”
The committee interpreted the term “scientifically up-to-date” in several ways. The first was to determine if the information on individual registry participants was up-to-date, and the second was whether the registry questionnaire captures scientifically up-to-date information on participants. Although their responses to each question and on current health status can be considered up-to-date at the time of submission, participants cannot provide additional health information nor update it at a later time with any new symptoms or diagnoses they may have developed since completing the questionnaire. And as noted in Chapter 7, health information obtained during the optional health evaluation is not used to confirm, correct, or update the participant’s information recorded in the registry. Therefore, a participant’s health information in the registry may be considered to be up-to-date to the best of the participant’s knowledge at the time he or she completed the questionnaire, but the information may not be medically up-to-date for that individual (i.e., he or she may be unaware of all of their health outcomes), and they are able to report only those health outcomes given in the questionnaire (i.e., specifics of some health conditions can be reported only at the organ system level).
Another interpretation was whether the questionnaire captured the most scientifically up-to-date information on health effects that may result from deployment exposures to airborne hazards and burn pits. As explained in Chapter 3, the questionnaire does not allow participants to enter any health symptoms or diagnoses other than those given in the specific questions. Many registry participants have health outcomes that are not included in the questionnaire, as described in Chapter 7. This makes it difficult to identify any health effects other than those in the questionnaire that may be associated with deployment exposures and limits the ability of VA to explore those health effects. The committee notes that in 2021, VA made a presumption of service connection for asthma, rhinitis, and sinusitis for veterans exposed to fine particulate matter in the Southwest Asia theater (Federal Register, 2021). However, the registry questionnaire only asks participants whether they have asthma; sinusitis and rhinitis are not included in the questionnaire, and therefore VA cannot have used the registry to assist it in making the service connection for these two health outcomes.
The committee further considered whether the AH&OBP Registry questionnaire itself was scientifically up-to-date. As noted by both the initial assessment committee and this reassessment committee, the questionnaire was not developed with input from survey design experts, had limited pilot testing, and, as described in Chapter 3, has numerous validation issues. The few changes made to the registry questionnaire since the initial assessment—revised questions regarding the desire for a health evaluation and contact information—have not been pilot tested with potential or current registry participants. Questions on deployment exposures and health outcomes, including asking about sinusitis and rhinitis, which are now service connected, have not changed since the registry began. Therefore, the registry questionnaire cannot be considered to be scientifically up-to-date.
To address whether the information collected by the registry is scientifically up-to-date, the committee conducted a literature search and review as described in Chapter 2. That search indicated that there are very few studies being conducted to examine whether exposure to airborne hazards, and burn pits specifically, results in new health outcomes or might exacerbate existing ones. Only seven new published studies and four ongoing funded studies on this topic were identified.
Given the level of concern evinced by the ever-growing number of AH&OBP Registry participants, the committee finds it surprising that there is not more ongoing research to enhance the understanding of the relationship between deployment exposures to airborne hazards and burn pits and health outcomes.
Additional Areas for Recommendations
The committee was also asked to make recommendations in the following areas:
- the most effective and prudent means of using the AH&OBP Registry or another system of records to provide information that translates into learning more about the conditions that are likely to result from exposure to open burn pits and to improve the collection and maintenance of such information;
- the best way to utilize resources for airborne hazards research (Does, for example, a more cost-effective way than the AH&OBP Registry exist to discover associations between airborne hazards and burn pit exposures and disease?);
- how to address gaps identified in the initial report (and how initial recommendations were used) and in burn pit and airborne hazards research, diagnosis, and treatment in general; and
- what alternative form of surveillance and identification of research candidates would need to be identified if the AH&OBP Registry was closed?
Using Alternate Systems of Records and Data Sources for Airborne Hazards Research
To address the first two bullets above and throughout this report, the committee has explored whether alternate data sources or approaches might replace or supplement the AH&OBP Registry for etiologic research; population health surveillance; improving clinical care; informing VA processes and policies; and communicating with veterans, service members, health care providers, and other stakeholders about the exposure to airborne hazards and burn pits and possible health effects. As discussed in chapters 5–9, there are several data sources, including other registries, that attempt to achieve some aspects of the AH&OBP Registry, but the committee found that no single source or combination of sources currently exists that could adequately fulfill the five intended purposes of the AH&OBP Registry. However, some data sources, such as the Gulf War Registry and the World Trade Center Health Registry, provide valuable services to their participants and might serve as exemplars for some functions of the AH&OBP Registry, but the potential contributions of other data sources, such as ILER, to help meet at least one congressional- or VA-stated purpose of the registry are unknown.
To actually accomplish several of the AH&OBP goals, the committee has recommended that VA support the conduct of epidemiologic studies that meet the six identified characteristics for etiologic research. One such approach would be the tiered design described in the 2011 report Long-term Health Consequences of Exposure to Burn Pits in Iraq and Afghanistan (IOM, 2011). Although the series of studies recommended by that committee—and endorsed by this committee—would require substantial resources, particularly time and data collection, this committee expects that they would be cost-effective in terms of discovering associations between airborne hazards and burn pit exposures and disease. Prospective, long-term, outcome-based epidemiologic studies with well-defined a priori research questions and improved exposure assessment will be necessary to examine these associations and identify health outcomes that may be the subject of a population health surveillance, or at the very least a health monitoring system. The committee is aware of several ongoing research efforts that have been initiated to address the health effects of these exposures. VA, DoD, and other federal agencies have not focused on conducting large, methodologically rigorous studies of the health effects of exposure to burn pit emissions specifically. As discussed in Chapter 2, this may be due in part to the limited exposure data that are available and to the extremely difficult task of assigning airborne hazards to specific pollution sources, even burn pits, that were known to be present at most of the military installations in the Southwest Asia theater.
Given the complexity of assessing the impact of airborne hazards and open burn pit exposures, multiple and complementary data sources should be the goal for military health research and should be built into the framework of outcomes research. This framework would need to be resourced appropriately, limited in redundancy, use both subjective and objective data, with data use agreements managed in a systems-based approach, and with experts involved who have a keen awareness and a comprehensive understanding of the limitations and strengths of these multiple data sources.
Addressing Data Gaps
To address the third bullet on “how to address gaps identified in the initial report (and how initial recommendations were used) and on burn pit and airborne hazards research, diagnosis, and treatment in general,” the reassessment committee considered the recommendations made by the initial assessment committee and VA’s responses to those recommendations in chapters 3, 5, 7, and 9 of this report. Those recommendations were intended to address gaps that the initial assessment committee identified in the first years of AH&OBP Registry operations. The request that the reassessment committee identify gaps in the research, diagnosis, and treatment of possible
health effects stemming from exposure to airborne hazards and burn pits during deployment was addressed in the previous National Academies report Respiratory Health Effects of Airborne Hazards Exposures in the Southwest Asia Theater of Military Operations (NASEM, 2020). Furthermore, that report along with the 2011 IOM report may be used to inform the development and conduct of an epidemiologic study or studies that fulfill the six characteristics for etiologic research. To address the diagnosis and treatment of conditions that may be due to airborne hazards exposures, a system that provides high quality, patient-centered care is needed; the AH&OBP Registry does not and cannot do so.
Potential End State for the AH&OBP Registry
Although the initial assessment committee offered nine recommendations to enhance the AH&OBP Registry or the data collected by it, in the 5 years since those recommendations were issued, few changes have been made, and those changes have had little impact on the larger and remaining structural issues of the AH&OBP Registry. The committee has noted throughout this report some areas where modest improvements could be made, but those are not intended to serve as a checklist of actions that would be needed, nor would they individually or collectively have a major impact on the registry’s functions or abilities. Relatively minor changes, such as those made to the wording of specific questions may improve data quality in a general way but still would not be enough to allow the registry to fulfill several of its stated purposes, specifically support for etiologic research and population health surveillance. Other improvements, which may be considered in part to respond to participant and stakeholder concerns, such as allowing participants to add additional deployment information, may sound proactive and useful, but increasing data collection and improving data quality for its own sake is not useful if the registry still will not be able to fulfill its intended purposes. As such, because the AH&OPB Registry does not meet the minimum criteria to perform some of the functions for which it is intended, this may be potentially its end state in this form, which is why the committee recommends a new phase of the AH&OBP Registry be implemented that can focus on attainable functions.
As discussed in Chapter 3, developing and maintaining a registry is not cost-free to either participants or sponsors. As of July 1, 2022, more than 317,000 participants had completed and submitted the registry questionnaire. In addition, over 130,000 individuals had enrolled but did not complete or submit the questionnaire. A very conservative estimate is that participants have invested a minimum of 200,000 person-hours in providing information for the AH&OBP Registry. This does not include the additional time of the more than 30,000 participants who opted to receive the AH&OBP Registry health evaluation between June 2014 and February 2022, nor the time they spent contacting and scheduling the health evaluation, traveling to the VA facility for evaluation, waiting to be seen, having the evaluation along with any associated laboratory tests, and discussing or following up on results with primary care providers. Therefore, if the data are not able to be used for the intended functions (etiologic research and population health surveillance), then a different mechanism is needed to discover associations between airborne hazards and burn pit exposures and adverse health outcomes.
Although the committee’s Statement of Task directed it to consider a “more cost-effective way than the AH&OBP Registry” to discover associations between airborne hazards and adverse health outcomes, multiple mechanisms, as opposed to a single action or mechanism, are likely to be needed to adequately fulfill the five functions that the AH&OBP Registry was intended to serve. For example, etiologic research into associations between airborne exposures and adverse health outcomes would be improved by funding and conducting well-designed epidemiologic studies or perhaps adding new, validated exposure questions to existing cohort studies, such as follow-ups of the Millennium Cohort Study. Complete cost information was not available for many alternative sources that were considered—or for the AH&OBP Registry itself—so it was not possible to perform cost-analysis comparisons. However, the use of an alternative source or system that is able to perform a required function versus one that cannot may be considered cost-effective from one standpoint.
The AH&OBP Registry could be a unique and valuable resource for bidirectional communications between veterans and service members (most of whom will eventually be eligible for VA health care) and VA. The registry could also serve as a communication avenue for health care providers, Congress, and others with responsibility for addressing the health concerns of veterans; this communication need alone warrants continuation of the registry. None of the other mechanisms allow for this self-identification of veterans’ interests and concerns, and so this function needs to be preserved and enhanced in a new, more efficient, and impactful phase of the AH&OBP Registry.
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VA OIG (Department of Veterans Affairs, Office of Inspector General). 2022. Airborne Hazards and Open Burn Pit Registry exam process needs improvement. Report #21-02732-153. July 21. https://www.oversight.gov/sites/default/files/oig-reports/VA/VAOIG-21-02732-153.pdf (accessed August 16, 2022).
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