Pregnancy Outcomes of Veterans (PROVE)

退伍军人的怀孕结果（证明）

• 批准号: 8866174
• 负责人: CIARAN S. PHIBBS
• 金额: --
• 依托单位: VETERANS ADMIN PALO ALTO HEALTH CARE SYS
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-04-01 至 2017-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8866174
• 关键词: Accounting; Address; Affect; Afghanistan; Age; Applications Grants; Area; Birth; Birth Certificates; Birth Weight; Budgets; California; Caring; Censuses; Cessation of life; Characteristics; Chronic; Chronic stress; Cohort Studies; Comorbidity; Complex; Congenital Abnormality; Data; Data Analyses; Data Element; Data Linkages; Data Set; Death Certificates; Diagnosis; Discipline of obstetrics; Enrollment; Environmental Exposure; Environmental Risk Factor; Ethnic Origin; Exposure to; Face; Fathers; Feedback; Fees; Female; Fetal Death; Funding; General Population; Gestational Age; Gulf War; Hazardous Substances; Health Services; Healthcare; High Prevalence; Hospitalization; Human Subject Research; Hypertension; Immigration; Infant; Information Resources; Insurance; Insurance Coverage; Iraq; Knowledge; Leadership; Left; Link; Literature; Maternal Age; Measures; Medicaid; Medical; Mental Depression; Mental Health; Methodology; Methods; Military Personnel; Minority; Modeling; Mothers; Nature; Neighborhoods; Neonatal Mortality; Outcome; Parents; Patient Discharge; Policies; Population; Post-Traumatic Stress Disorders; Pre-Eclampsia; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Premature Birth; Prenatal care; Prevalence; Process; Race; Recording of previous events; Records; Registries; Regression Analysis; Relative (related person); Research; Research Personnel; Resources; Risk; Risk Factors; Role; Sample Size; Science; Secure; Services; Source; Stratification; Stress; Translational Research; Trauma; United States National Institutes of Health; Veterans; Vital Statistics; Woman; Women' s Health Services; Work; abstracting; base; cohort; congenital anomaly; design; evidence base; experience; health data; high risk; impression; improved; infant death; infant outcome; innovation; insight; interest; male; novel; offspring; operation; premature; prenatal; programs; psychosocial; regional pollution; reproductive; response; sexual trauma; social; stressor; young man; young woman

 DESCRIPTION (provided by applicant): Anticipated Impact on Veterans Health Care: Women are a growing share of the VA population, especially among younger veterans. A better understanding of the differential risk for reproductive outcomes among veterans will help VA provide better reproductive care to veterans. For example, this study will provide a better understanding of the preterm delivery risk associated with PTSD, which will help VA design programs to help mitigate this risk. It will also provide VA with a wealth of information about how the pregnancy risks of VA enrollees compare to the general population, including data on VA enrollees who use other forms of insurance for their pregnancy care. Project Background: Reproductive outcomes are sensitive to many factors, including environmental exposures and maternal co-morbidities. For example, there are small studies that suggest that service in the first Gulf War by either the mother or father was associated with increased risk for congenital anomalies. The PI has conducted a preliminary study with VA fee data that found that maternal PTSD is associated with spontaneous preterm delivery. We also found that this effect was larger in women who also screened positive for military sexual trauma (MST). The PTSD study only had data on the fact that a spontaneous preterm delivery occurred, with no data on extent of prematurity, other causes of preterm delivery, or infant outcomes. This study will fill a significant gap in our knowledge of the effectof maternal PTSD on preterm delivery and add a novel exploration of the effects of paternal PTSD on preterm delivery. Project Objectives: The project will use linked VA and California data to: Aim 1: Elucidate the effect of maternal PTSD on birth outcomes, confirming the increased risk of preterm birth, quantifying the distribution and character of such preterm births, and exploring other outcomes such as maternal complications (e.g., preeclampsia) and neonatal mortality. Aim 2: Determine if paternal PTSD status affects preterm delivery. Aim 3: Determine how pregnancy outcomes for Veterans (males and females) differ from those of the general population and provide information on the pregnancy risks and outcomes of veterans. Project Methods: We will link VA data with the California birth cohort linked data (VS-PDD) using birth certificates, infant death certificates, fetal death certificates, discharge abstracts for the mothrs and infants, including prenatal hospitalizations and infant transfers. The PI led the NIH-funded project that created the initial 10 years of the California VS-PDD data and has confirmed that sufficient data elements are available to link to VA data. We will expand this methodology to identify deliveries to VA enrollees (mothers and fathers) and to add VA data about them (e.g., OEF/OIF deployment, PTSD diagnosis). These linked data will allow for a more complete understanding of pregnancy outcomes than is possible from any of the component datasets. Projections from VA fee data and Medicaid data from the VA Information Resource Center (VIREC) indicate that this linkage will yield at least 13,000 deliveries to women veterans enrolled in VA, with the likely number being much larger. The comparison population is very large at over 500,000 birth/year. We will use regression analysis to control for medical (e.g., PTSD, hypertension) and social- demographic (e.g., age, race/ethnicity) risk factors to examine reproductive outcomes for different populations for a wide range of reproductive outcomes (e.g., preterm delivery, birth weight, pregnancy complications such as preeclampsia, congenital anomalies). We will compare VA enrollees to the non-VA population and examine special high risk groups (e.g., PTSD). The data will be maintained on the secure research server at the Palo Alto VA. CRITIQUE 1 1. Significance. This study is measuring the association between PTSD and pregnancy outcomes. It does so using three aims: * Relationship between maternal PTSD and birth outcomes; * Relationship between paternal PTSD and birth outcomes; * Difference in pregnancy outcomes between veterans and the general population. This is a resubmission of a previous grant proposal. The reviewers were responsive to feedback from earlier reviewers. The VA is increasingly purchasing/providing obstetrical care, and this is a relevant and feasible study with potentially significant implications for the VA. The proposal provides a thoughtful conceptual model which provides guidance regarding how they believe military enrollment and veteran-specific factors may impact pregnancy outcomes. This study leverages the linkability of veteran's VA-based health data and obstetric health services provided in non-VA settings. This linkable data can provide unique insights, on a population-level in California, into the relationship between birth outcomes and PTSD. Evidence in non-veteran studies has pointed to an effect of PTSD on pregnancy outcomes. The first aim appears to be incremental, as this aim proposes to carefully examine the relationship between maternal PTSD and birth outcomes. The VS-PDD linkage provides a number of specific birth outcomes not routinely collected in VA data. This proposal extends the science by outlining a careful analysis of the roles of PTSD and deployment history in outcomes of: preterm birth, maternal complications, birth defects and death. The VA is likely the best place for this avenue of research since veterans have a higher prevalence of PTSD than the general population and routinely screens for PTSD. The second aim examining the association between birth outcomes and paternal factors is novel. Since there is a basis in evidence paternal factors affecting pregnancy outcomes, the findings from this study will contribute to the literature. The objective of the third aim is to provide a basis of evidence regarding the pregnancy outcomes of veterans relative to non-veterans. There is a gap in the strength of this evidence, and the findings of this study will be important to the VA for policy and planning purposes. 2. Approach (including Feasibility). There are a number of technical questions. These questions are not major. How is deployment history (OEF/OIF registry) categorized and included in the model; how is the sensitivity of the categorization of this variable assessed? For instance, how is duration of service reflected in the model? The regional pollution levels provide insight into environmental factors that may impact birth outcomes, but they are poorly described. For instance, are the regional pollution levels variable by day or month, and how are temporal data incorporated into the models? The proposal describes linkage to census data to obtain neighborhood characteristics, but these are poorly described. The proposal describes that many missing paternal SSNs are related to undocumented immigration status; does this affect the generalizability or bias the results in a specific directin? 3. Impact and Innovation. The impact of this proposal is significant and addresses an area where research is sparse. 4. Investigator Qualifications, and Facilities and Resources. Excellent. 5. Multiple PI Leadership Plan. (if applicable) 6. Adequacy of Response to Previous Feedback Provided by HSR&D Regarding the Proposed Study. Very thorough response to previous feedback. 7. Protection of Human Subjects from Research Risk. Adequate for secondary data analyses. 8. Inclusion of Women and Minorities in Research. Adequate. 9. Budget. Adequate - modest budget for two year study. 10. Overall Impression. 11. Key Strengths. 1. Linking VA data with California's VS-PDD. 2. Investigators with excellent experience with these data. 3. Data driven study will provide results that address gaps in VA's understanding of the roles of maternal/paternal PTSD and obstetric outcomes. 12. Key Weaknesses. 1. Impact of the potential findings on VA policy is unclear. 2. The handling of temporal effects of some variables in the model is unclear.

 描述（由申请人提供）： 对退伍军人医疗保健的预期影响：女性在退伍军人管理局人口中所占的比例越来越大，尤其是在年轻的退伍军人中。更好地了解退伍军人生殖结果的差异风险将有助于退伍军人管理局为退伍军人提供更好的生殖护理。例如，这项研究将更好地了解与 PTSD 相关的早产风险，这将有助于 VA 设计项目来帮助减轻这种风险。它还将为 VA 提供有关 VA 参保者与普通人群的怀孕风险比较的丰富信息，包括 VA 参保者使用其他形式的怀孕护理保险的数据。项目背景：生殖结果对许多因素都很敏感，包括环境暴露和孕产妇合并症。例如，有一些小型研究表明，母亲或父亲在第一次海湾战争中服役与先天性异常的风险增加有关。 PI 对 VA 费用数据进行了一项初步研究，发现母亲的 PTSD 与自发性早产有关。我们还发现，对于军事性创伤（MST）筛查呈阳性的女性来说，这种影响更大。 PTSD 研究仅提供有关自发性早产这一事实的数据，而没有有关早产程度、早产的其他原因或婴儿结局的数据。这项研究将填补我们对母亲 PTSD 对早产影响的认识上的重大空白，并对父亲 PTSD 对早产的影响进行新的探索。项目目标：该项目将使用 VA 和加利福尼亚州的相关数据来： 目标 1：阐明孕产妇 PTSD 对出生结果的影响，确认早产风险增加，量化此类早产的分布和特征，并探索其他结果，例如孕产妇并发症（例如先兆子痫）和新生儿死亡率。 目标 2：确定父亲的 PTSD 状态是否会影响早产。 目标 3：确定退伍军人（男性和女性）的妊娠结局与普通人群的妊娠结局有何不同，并提供有关退伍军人的妊娠风险和结局的信息。项目方法：我们将使用出生证明、婴儿死亡证明、胎儿死亡证明、母亲和婴儿的出院摘要（包括产前住院和婴儿转院）将 VA 数据与加州出生队列关联数据 (VS-PDD) 连接起来。该 PI 领导了 NIH 资助的项目，该项目创建了加州 VS-PDD 最初 10 年的数据，并已确认有足够的数据元素可用于链接到 VA 数据。我们将扩展此方法，以识别 VA 登记者（母亲和父亲）的分娩情况，并添加有关他们的 VA 数据（例如，OEF/OIF 部署、PTSD 诊断）。与任何组成数据集相比，这些关联数据将使我们能够更全面地了解妊娠结局。 VA 费用数据和 VA 信息资源中心 (VIREC) 的医疗补助数据预测表明，这种联系将为 VA 注册的女退伍军人提供至少 13,000 次分娩，而且实际数字可能要大得多。对比人口规模非常大，每年出生人数超过 500,000 人。我们将使用回归分析来控制医学（例如，创伤后应激障碍、高血压）和社会人口学（例如，年龄、种族/民族）风险因素，以检查不同人群的生殖结果，以获得广泛的生殖结果（例如，早产、出生体重、妊娠并发症，如先兆子痫、先天性异常）。我们将比较 VA 参与者与非 VA 人群，并检查特殊的高风险群体（例如 PTSD）。数据将保存在弗吉尼亚州帕洛阿尔托的安全研究服务器上。 批评 1 1. 意义。 这项研究正在测量创伤后应激障碍（PTSD）与妊娠结局之间的关联。它这样做有三个目标： * 产妇PTSD与出生结局之间的关系； * 父亲的PTSD与出生结果之间的关系； * 退伍军人和普通人群之间妊娠结局的差异。 这是对先前拨款提案的重新提交。审稿人对早期审稿人的反馈做出了回应。退伍军人管理局越来越多地购买/提供产科护理，这是一个 对 VA 具有潜在重大影响的相关且可行的研究。 该提案提供了一个深思熟虑的概念模型，为他们认为入伍和退伍军人特定因素如何影响妊娠结局提供了指导。这项研究利用了退伍军人基于 VA 的健康数据与非 VA 环境中提供的产科健康服务的关联性。这些可链接的数据可以在加利福尼亚州的人口层面上提供关于出生结果与创伤后应激障碍（PTSD）之间关系的独特见解。 非退伍军人研究的证据表明创伤后应激障碍对妊娠结局有影响。第一个目标似乎是渐进的，因为该目标建议仔细检查母亲创伤后应激障碍与出生结果之间的关系。 VS-PDD 关联提供了 VA 数据中未常规收集的许多特定出生结果。该提案通过概述对 PTSD 的作用和部署历史在早产、孕产妇并发症、出生缺陷和死亡等结果中的作用的仔细分析扩展了科学。退伍军人管理局可能是进行这一研究的最佳场所，因为退伍军人的 PTSD 患病率高于普通人群，并且会定期筛查 PTSD。 第二个目的是检查出生结果与父亲因素之间的关联，这是新颖的。由于有证据表明父亲因素影响妊娠结局，因此本研究的结果将为文献做出贡献。 第三个目标是为退伍军人相对于非退伍军人的妊娠结局提供证据基础。这一证据的强度存在差距，这项研究的结果对于退伍军人事务部的政策和规划目的非常重要。 2. 方法（包括可行性）。 有许多技术问题。这些问题并不重要。 部署历史记录（OEF/OIF 注册表）如何分类并包含在模型中；如何评估该变量分类的敏感性？例如，服务期限如何反映在模型中？ 区域污染水平可以让我们深入了解可能影响出生结果的环境因素，但对这些因素的描述却很少。例如，区域污染水平是否按天或按月变化，以及如何将时间数据纳入模型中？ 该提案描述了与人口普查数据的联系以获得邻里特征，但这些描述很少。 该提案指出，许多缺失的父亲 SSN 与无证移民身份有关；这是否会影响特定方向结果的普遍性或偏差？ 3.影响和创新。 该提案的影响是重大的，并且解决了研究稀少的领域。 4. 研究者资格、设施和资源。 出色的。 5. 多个 PI 领导计划。 （如适用） 6. 对 HSR&D 先前提供的有关拟议研究的反馈的回应是否充分。 对之前的反馈做出了非常彻底的回应。 7. 保护人类受试者免受研究风险。 足以进行二次数据分析。 8. 让妇女和少数群体参与研究。 足够的。 9. 预算。 两年学习的充足预算。 10.总体印象。 11. 主要优势。 1. 将 VA 数据与加州的 VS-PDD 连接起来。 2. 调查人员对这些数据具有丰富的经验。 3. 数据驱动的研究将提供结果，以解决 VA 对母亲/父亲 PTSD 和产科结果的作用的理解差距。 12. 主要弱点。 1. 潜在调查结果对退伍军人事务部政策的影响尚不清楚。 2.模型中某些变量的时间效应的处理尚不清楚。