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

Tsepamo 出生结果监测研究已收集了数千名感染艾滋病毒的妇女 博茨瓦纳。 Tsepamo Plus 研究（项目 1）将继续收集妊娠期间的抗逆转录病毒药物暴露情况，其中 很少有人进行高精度的研究。因为当存在很多不确定性时，Tsepamo 可以提供高精度 Tsepamo 表示，关于怀孕安全，博茨瓦纳通常会先于其他非洲国家推出新的抗逆转录病毒药物 可能是第一个报告新颖安全信号的人。这反过来又使 Tsepamo 在 了解抗逆转录病毒药物对妊娠的不良影响。此外，仅监测数据就可以而且应该被使用 为个人、临床或社会决策提供信息，特别是当随机试验成本太高时， 不道德，或者不够及时。该提案的目标是评估方法并提供 关于充分利用 Tsepamo 数据和类似研究的方法的指导。具体来说，我们的目标是创建 关于何时公开报告基于计划外分析的安全信号的指南；评估统计数据 各种组序贯方法的性质；制定并实施方法来衡量结果 Tsepamo 提供了一项随机试验的结果；并在内部制定和改进三角测量策略 妊娠相关监测数据。

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.