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Research standardization tools: Pregnancy measures in the PhenXToolkit

机译：研究标准化工具：PhenX中的怀孕措施工具包

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Only through concerted and well-executed research endeavors can we gain the requisite knowledge to advance pregnancy care and positively impact maternal and newborn health. Yet the heterogeneity inherent in individual studies limits our ability to compare and synthesize study results, thus impeding the capacity to draw meaningful conclusions that can be trusted to inform clinical care. The PhenX Toolkit (), supported since 2007 by the National Institutes of Health, is a web-based catalog of standardized protocols for measuring phenotypes and exposures relevant for clinical research. In 2016, a working group of pregnancy experts recommended 15 measures for the PhenX Toolkit that are highly relevant to pregnancy research. The working group followed the established PhenX consensus process to recommend protocols that are broadly validated, well-established, nonproprietary, and have a relatively low burden for investigators and participants. The working group considered input from the pregnancy experts and the broader research community and included measures addressing mode of conception, gestational age, fetal growth assessment, prenatal care, mode of delivery, gestational diabetes, behavioral and mental health, and environmental exposure biomarkers. These pregnancymeasures complement the existing measures for other established domains in thePhenX Toolkit, including reproductive health, anthropometrics, demographiccharacteristics, and alcohol, tobacco, and other substances. The precedingdomains influence a woman's health during pregnancy. For each measure,the PhenX Toolkit includes data dictionaries and data collection worksheets thatfacilitate incorporation of the protocol into new or existing studies. Themeasures within the pregnancy domain offer a valuable resource to investigatorsand clinicians and are well poised to facilitate collaborative pregnancyresearch with the goal to improve patient care. To achieve this aim,investigators whose work includes the perinatal population are encouraged toutilize the PhenX Toolkit in the design and implementation of their studies,thus potentially reducing heterogeneity in data measures across studies. Such aneffort will enhance the overall impact of individual studies and increasing theability to draw more meaningful conclusions that can then be translated intoclinical practice.
机译：只有通过协调一致且执行良好的研究工作，我们才能获得必要的知识，以促进妊娠护理并积极影响孕产妇和新生儿的健康。然而，个别研究固有的异质性限制了我们比较和综合研究结果的能力，从而阻碍了得出有意义的结论的能力，这些结论可以被信任用于临床护理。自2007年以来，美国国立卫生研究院（National Institutes of Health）一直支持PhenX Toolkit（），它是基于Web的标准协议目录，用于测量与临床研究相关的表型和暴露水平。在2016年，怀孕专家工作组建议了针对PhenX Toolkit的15项与怀孕研究高度相关的措施。工作组遵循已建立的PhenX共识程序，以推荐经过广泛验证，建立良好，非专有的协议，这些协议对调查人员和参与者的负担相对较小。工作组考虑了来自妊娠专家和更广泛的研究界的意见，并包括了针对怀孕方式，胎龄，胎儿生长评估，产前保健，分娩方式，妊娠糖尿病，行为和精神健康以及环境暴露生物标志物的措施。这些怀孕措施补充了针对其他现有领域的现有措施PhenX工具包，包括生殖健康，人体测量学，人口统计以及酒精，烟草和其他物质。前面的域名会影响孕妇在怀孕期间的健康。对于每项措施PhenX工具包包含数据字典和数据收集工作表，这些工作表促进将方案纳入新的或现有的研究中。的怀孕领域的措施为研究人员提供了宝贵的资源和临床医生，并准备好促进协同妊娠以改善患者护理为目标的研究。为了达到这个目的，鼓励从事围产期工作的研究人员在设计和实施研究中利用PhenX工具包，因此有可能减少整个研究中数据指标的异质性。这样的努力将增强个别研究的总体影响并增加得出更有意义的结论的能力，然后可以将其转化为临床实践。

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