Planning of Pediatric Anesthesia and NeuroDevelopment Assessment (PANDA) Study

描述（由申请人提供）：本R34申请描述了一项计划补助金（以下称为“R34”），该补助金将制定程序手册（MOP）并将系统放置到位，以便我们能够成功实施并完成完整的儿科麻醉神经发育评估（PANDA）研究（“完整的PANDA研究”）。完整PANDA研究的资金将在稍后通过常规R01申请寻求。我们将在R34中使用与我们建议的完整PANDA研究相同的研究程序，以优化运营物流。我们还将使用R34开发数据管理和神经心理学测试的研究基础设施，并巩固完整PANDA研究的研究中心网络。我们将以研究方案研讨会结束，以最终确定完整PANDA研究的MOP。完整的PANDA研究将解决健康婴儿有限麻醉暴露对神经发育影响的关键公共卫生问题。本研究设计是一个跨学科和经验丰富的研究者团队的努力，他们将继续作为完整PANDA研究的积极关键研究者。拟议的完整PANDA研究设计涉及对36个月龄前接受疝手术的婴儿历史队列进行前瞻性神经心理学评估。这既有效又具有成本效益，因为一旦我们确定了研究受试者，并确认了他们的资格，并且他们同意参加研究，研究程序就涉及单次神经心理学测试，在此期间将完成与研究受试者及其兄弟姐妹有关的所有数据收集。将不会因失访而导致减员，并且将在可预测的时间轴内完成完整的PANDA研究。完整的PANDA研究结果将是明确的、可解释的，并具有广泛的适用性，因为在择期手术期间麻醉暴露有限的健康婴儿构成了接受麻醉的最大儿童群体。因此，完整的PANDA研究结果将在合理的时间内以合理的成本对儿童健康产生巨大而显著的影响。在R34期间，我们计划识别、招募、安排和测试10对兄弟姐妹，以评估和优化我们研究程序的运营物流。我们将使用R34规划补助金为全面PANDA研究建立基础设施的所有基本要素。我们将最终确定所需研究中心的总数。我们将建立神经心理学测试核心，以确保在不同研究中心进行的测试产生跨研究中心的可靠性、再现性和恒定性结果，从而为研究的有效性提供信心。我们将开发数据管理结构，使我们能够有效和可靠地输入，检索和分析数据。最后，我们计划举办一个研究方案研讨会，最终确定研究方案，一旦PANDA研究开始，就可以立即实施。与R34一起安装的系统将使我们能够成功实施完整的PANDA研究，并使我们能够以可预测、及时和具有成本效益的方式完成研究。 公共卫生相关性：修订后的R34申请中概述的计划活动是为未来的大规模多中心儿科麻醉神经发育评估（PANDA）研究（完整PANDA研究）制定并最终确定程序手册（MOP）。R34的系统和基础设施将使我们能够以可预测、及时和具有成本效益的方式成功实施和完成完整的PANDA研究。完整的PANDA研究将作为R01申请提交。

DESCRIPTION (provided by applicant): This R34 application describes a planning grant (hereafter called the "R34") that will develop the Manual of Procedures (MOP) and put the systems in place so we could successfully implement and complete the full Pediatric Anesthesia Neurodevelopment Assessment (PANDA) study (the "Full PANDA Study"). The funding for the Full PANDA Study will be sought later through a regular R01 application. We will use the same study procedures in the R34 as we propose for the Full PANDA Study to optimize operational logistics. We will also use the R34 to develop the study infrastructures for data management and neuropsychological testing and consolidate the network of study sites for the Full PANDA Study. We will conclude with a Study Protocol Workshop to finalize the MOP for the Full PANDA Study. The Full PANDA Study will address the critical public health issue of the neurodevelopment effects of limited anesthesia exposure in healthy infants. The study design was the effort of an interdisciplinary and experienced team of investigators, all of whom will continue as active key investigators in the Full PANDA Study. The proposed Full PANDA Study design involves prospective neuropsychological assessment of a historic cohort of infants who had hernia surgery prior to 36 months of age. This is both efficient and cost-effective, because once we have identified the study subjects, and confirmed their eligibility, and they have agreed to participate in the study, the study procedures involve a single session of neuropsychological testing during which all data collection pertaining to the study subject and his/her sibling will be completed. There will be no attrition from loss to follow up and the Full PANDA Study would be completed within a predictable timeline. The Full PANDA Study results will be clear, interpretable and have wide applicability, since healthy infants with limited anesthesia exposure during elective procedures constitute the largest group of children receiving anesthesia. The results from the Full PANDA Study will therefore have a large and significant impact on child health in a reasonable time and at reasonable cost. During the R34, we plan to identify, recruit, schedule and test 10 sibling pairs to evaluate and optimize operational logistics of our study procedures. We will use the R34 planning grant to put in place all essential elements of the infrastructure for the Full PANDA Study. We will finalize the total number of study sites needed. We will establish the neuropsychological testing core that will ensure the testing performed at different sites produce results with reliability, reproducibility and constancy across sites, thus providing confidence in the study's validity. We will develop the data management structure that would allow us to enter, retrieve and analyze data effectively and reliably. Finally, we plan to have a Study Protocol Workshop that will finalize the study protocol which would be ready for immediate implementation as soon as the PANDA study begins. The systems put in place with the R34 will allow us to successfully implement the Full PANDA Study, and enable us to complete the study in a predictable, timely and cost effective manner. PUBLIC HEALTH RELEVANCE: The planning activities outlined in the revised R34 application are to develop and finalize the Manual of Procedures (MOP) for the future large scale multi-site Pediatric Anesthesia Neurodevelopment Assessment (PANDA) study (the Full PANDA Study). The systems and infrastructure put in place with the R34 will allow us to successfully implement and complete the Full PANDA Study in a predictable, timely and cost-effective manner. The Full PANDA Study will be submitted as a R01 application.