Methodology: Developing Reporting Criteria for Pregnancy Surveillance Cohorts and New Techniques for Supporting Target Trials

特塞帕莫出生结果监测研究积累了数以千计的艾滋病毒携带者 博茨瓦纳。TSepamo Plus研究(项目1)将继续收集怀孕期间接触ARV的情况 很少有高精度的研究。因为TSepamo可以在存在很大不确定性的情况下提供高精度 关于怀孕的安全性，博茨瓦纳通常在其他非洲国家之前推出新的抗逆转录病毒药物，特塞帕莫 可能是第一个报道新的安全信号的公司。这反过来又使特塞帕莫在世界上具有很大的影响力 对妊娠期抗逆转录病毒药物不良影响的了解。此外，单凭监测数据就可以而且应该使用。 为个人、临床或社会决策提供信息，特别是在随机试验过于昂贵的情况下， 不道德的，或者不够及时的。本提案的目标是评估方法并提供 关于最佳利用特塞帕莫数据和类似研究方法的指导。具体地说，我们的目标是创造 关于何时根据计划外分析公开报告安全信号的指导；评估统计数据 各种分组序贯方法的特性；开发和实现方法，以从 TSepamo与随机试验的结果；并在 怀孕相关的监测数据。

The Tsepamo birth outcomes surveillance study has accrued many thousands of women living with HIV from Botswana. The Tsepamo Plus study (Project 1) will continue to collect ARV exposures in pregnancy which are rarely studied with high precision. Because Tsepamo can provide high precision when there is much uncertainty about safety in pregnancy and Botswana typically rolls out new ARVs before other African countries, Tsepamo may be the first to report on novel safety signals. This in turn makes Tsepamo highly influential in the understanding of adverse ARV effects in pregnancy. Moreover, surveillance data alone can and should be used to inform personal, clinical, or societal decision-making, especially when randomized trials are too costly, unethical, or not timely enough. The objectives of this proposal are to evaluate methodologies and provide guidance on methods for making best use of Tsepamo data and similar studies. Specifically, we aim to create guidance on when to publicly report on safety signals based on unplanned analyses; evaluate the statistical properties of various group sequential methods; develop and implement methods to benchmark results from Tsepamo with results from a randomized trial; and develop and improve triangulation strategies within pregnancy-related surveillance data.