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：女性在退伍军人事务部人口中所占的比例越来越大，特别是在年轻退伍军人中，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事务部为退伍军人提供更好的生殖保健。更好地了解与 PTSD 相关的早产风险，这将有助于 VA 设计有助于减轻这种风险的计划。 它还将为 VA 提供有关 VA 参与者与一般人群的怀孕风险比较的丰富信息，包括。使用其他形式保险的 VA 登记者的数据项目背景：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，有小型研究表明，母亲或父亲在第一次海湾战争中服役与此有关。 PI 对 VA 费用数据进行了一项初步研究，发现孕产妇 PTSD 与自发性早产有关。我们还发现，这种影响在军事性创伤 (MST) 筛查呈阳性的女性中更大。 .创伤后应激障碍研究仅获得了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 对早产影响的认识的重大空白。并对父亲 PTSD 对早产的影响进行了新的探索 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：阐明母亲 PTSD 对出生结果的影响，确认早产风险增加。目标 2：确定父亲的 PTSD 状态是否影响早产。目标 3：确定退伍军人的妊娠结局。男性和女性）与一般人群不同，并提供有关退伍军人怀孕风险和结果的信息。 项目方法：我们将 VA 数据与加州出生队列相关数据联系起来。 (VS-PDD) 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。PI 领导了 NIH 资助的项目，该项目创建了加州 VS 的最初 10 年。 -PDD 数据，并已确认有足够的数据元素可用于链接到 VA 数据。我们将扩展此方法来识别 VA 登记者（母亲和父亲）的交付情况并添加有关他们的 VA 数据（例如， OEF/OIF 部署、PTSD 诊断）。这些关联数据将比任何组成数据集的预测更全面地了解妊娠结局。VA 费用数据和 VA 信息资源中心 (VIREC) 的医疗补助数据表明。这种联系将为退伍军人管理局注册的女性退伍军人带来至少 13,000 例分娩，而相对人口规模非常大，每年超过 500,000 例。我们将使用回归分析来控制医疗。 （例如，创伤后应激障碍（PTSD）、高血压）和社会人口学（例如，年龄、种族/民族）风险因素，用于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、先兆子痫等妊娠并发症） ）我们将比较 VA 参与者与非 VA 人群，并检查特殊高风险群体（例如 PTSD）。数据将保存在帕洛的安全研究服务器上。阿尔托 VA。批评 1 1. 意义。 这项研究旨在衡量创伤后应激障碍 (PTSD) 与妊娠结局之间的关联，其目的有以下三个： * 产妇PTSD与出生结局之间的关系； *父亲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。 这是对之前的拨款提案的重新提交。 VA 正在越来越多地购买/提供产科护理。 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退伍军人事务部的健康数据和非退伍军人事务部提供的产科健康服务的关联性。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，第一个目标似乎是渐进的，因为该目标建议仔细检查母亲 PTSD 与出生结果之间的关系。 VA 数据中不常规收集的特定出生结果通过概述 PTSD 的作用和部署历史在以下结果中的作用扩展了科学：VA 可能是最好的地方。对于这条大道研究表明，退伍军人的 PTSD 患病率高于普通人群，并且对 PTSD 进行常规筛查。 第二个目的是检查出生结果与父亲因素之间的关联，因为父亲因素影响妊娠结果是有依据的，所以这项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非常重要。和规划目的。 2. 方法（包括可行性）。 有很多技术问题，这些问题都不是主要问题。 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，模型中如何反映服务持续时间？ 区域污染水平提供了对可能影响出生结果的环境因素的深入了解，但它们的描述很差，例如，区域污染水平是按天还是按月变化，以及如何将时间数据纳入模型中？ 该提案描述了获取人口普查数据与社区特征的联系，但这些描述很少。 该提案描述了许多缺失的父亲 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见？ 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（如果适用）。 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。