Designing prospective cohort studies for assessing reproductive and developmental toxicity during sensitive windows of human reproduction and development--the LIFE Study.

Designing prospective cohort studies for assessing reproductive and developmental toxicity during sensitive windows of human reproduction and development--the LIFE Study.
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DOI:
10.1111/j.1365-3016.2011.01205.x
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发表时间:
2011-09
影响因子:
2.8
通讯作者:
Sundaram R
Sundaram R
中科院分区:
医学3区
文献类型:
--
作者:
Buck Louis GM;Schisterman EF;Sweeney AM;Wilcosky TC;Gore-Langton RE;Lynch CD;Boyd Barr D;Schrader SM;Kim S;Chen Z;Sundaram R

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代表LIFE研究的Buck Louis GM、Buckerman EF、Sweeney AM、Wilcosky TC、Gore-Langton RE、Lynch CD、Boyd巴尔D、Schrader SM、Kim S、Chen Z、Sundaram R。设计前瞻性队列研究,以评估人类生殖和发育敏感窗口期间的生殖和发育毒性-LIFE研究。儿科和围产期流行病学2011; 25:413-424。实施适合于招募计划怀孕夫妇的基于人口的抽样框架;获取生殖和发育敏感窗口期的环境数据;在家中收集生物标本;以及开发分层麻烦组数据的数据管理系统。环境与人类生殖力和生育力之间的关系实际上仍然没有从基于夫妇的角度进行研究,其中纵向暴露数据和生物标本是在敏感窗口中捕获的。作为回应,我们完成了LIFE研究,其方法旨在经验性地评估先验的所谓方法学挑战:我们使用了两个抽样框架(即鱼类/野生动物许可证登记处和直销数据库),针对16个假定存在持久性有机氯化学品环境暴露的目标县,招募501对计划怀孕的夫妇进行前瞻性纵向跟踪-在试图怀孕和整个怀孕期间。筛查率从目标人群(n = 424 423)的<1%到成功筛查的合格夫妇的42%不等; 84%的目标人群无法接触到,而36%的人拒绝筛查。在登记的夫妇中,约85%的人在尝试时完成了每日日志; 82%的孕妇完成了每日早孕日志,80%完成了每月妊娠日志。所有夫妇都提供了基线血液/尿液样本; 94%的男性提供了一个或多个精液样本,98%的女性提供了一个或多个唾液样本。妇女成功地使用尿生育监测仪确定排卵和家庭怀孕测试试剂盒。夫妇可以被招募为孕前队列,并将遵守在敏感窗口密集的数据收集。然而,适当规模的抽样框架是至关重要的,因为在所接触的夫妇中,合格的夫妇比例很小,据报在任何时候都计划怀孕。
Buck Louis GM, Schisterman EF, Sweeney AM, Wilcosky TC, Gore-Langton RE, Lynch CD, Boyd Barr D, Schrader SM, Kim S, Chen Z, Sundaram R, on behalf of the LIFE Study. Designing prospective cohort studies for assessing reproductive and developmental toxicity during sensitive windows of human reproduction and development – the LIFE Study. Paediatric and Perinatal Epidemiology 2011; 25: 413–424. implementation of population-based sampling frameworks suitable for recruiting couples planning pregnancy; obtaining environmental data across sensitive windows of reproduction and development; home-based biospecimen collection; and development of a data management system for hierarchical exposome data. The relationship between the environment and human fecundity and fertility remains virtually unstudied from a couple-based perspective in which longitudinal exposure data and biospecimens are captured across sensitive windows. In response, we completed the LIFE Study with methodology that intended to empirically evaluate a priori purported methodological challenges: We used two sampling frameworks (i.e. fish/wildlife licence registry and a direct marketing database) for 16 targeted counties with presumed environmental exposures to persistent organochlorine chemicals to recruit 501 couples planning pregnancies for prospective longitudinal follow-up while trying to conceive and throughout pregnancy. Enrolment rates varied from <1% of the targeted population (n = 424 423) to 42% of eligible couples who were successfully screened; 84% of the targeted population could not be reached, while 36% refused screening. Among enrolled couples, ~85% completed daily journals while trying; 82% of pregnant women completed daily early pregnancy journals, and 80% completed monthly pregnancy journals. All couples provided baseline blood/urine samples; 94% of men provided one or more semen samples and 98% of women provided one or more saliva samples. Women successfully used urinary fertility monitors for identifying ovulation and home pregnancy test kits. Couples can be recruited for preconception cohorts and will comply with intensive data collection across sensitive windows. However, appropriately sized sampling frameworks are critical, given the small percentage of couples contacted found eligible and reportedly planning pregnancy at any point in time.
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