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

方法：制定妊娠监测队列的报告标准和支持目标试验的新技术

• 批准号: 10696261
• 负责人: SONJA ALSEMGEEST SWANSON
• 金额: $ 5.91万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-24 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10696261
• 关键词: African; Benchmarking; Birth; Botswana; Calibration; Clinical; Computer software; Country; Data; Databases; Decision Making; Future; Guidelines; HIV; Infant; Influentials; Interdisciplinary Study; Methodology; Methods; Multiple Pregnancy; Neural Tube Defects; Observational Study; Outcome; Pregnancy; Pregnancy Outcome; Pregnant Women; Probability; Procedures; Program Sustainability; Property; Protocols documentation; Recommendation; Regimen; Reporting; Research; Research Design; Safety; Sample Size; Sampling; Signal Transduction; Statistical Data Interpretation; Subgroup; System; Techniques; Testing; Uncertainty; Weight Gain; Woman; antiretroviral therapy; cohort; cost; improved; mother nutrition; novel; premature; randomized trial; stillbirth; study population; surveillance data; surveillance study; unethical

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.

Tsepamo出生结果监测研究已经积累了数千名感染艾滋病毒的妇女， 波札那. Tsepamo Plus研究（项目1）将继续收集妊娠期ARV暴露情况， 很少有高精度的研究。因为Tsepamo可以在存在很多不确定性的情况下提供高精度 关于怀孕的安全性，博茨瓦纳通常会在其他非洲国家之前推出新的抗逆转录病毒药物， 可能是第一个报告新的安全信号的人。这反过来又使Tsepamo在世界上具有很大的影响力。 了解抗逆转录病毒药物在怀孕期间的不良影响。此外，监测数据本身可以而且应该被用来 为个人、临床或社会决策提供信息，特别是当随机试验成本过高时， 不道德的或者不及时的本提案的目标是评估各种方法， 关于最佳利用Tsepamo数据和类似研究的方法指南。具体来说，我们的目标是创造 关于何时公开报告基于计划外分析的安全性信号的指南;评估统计 各种组顺序方法的属性;开发和实施方法，以基准测试结果， Tsepamo与随机试验的结果;并制定和改善三角战略， 与怀孕有关的监测数据。