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首页> 美国卫生研究院文献>Springer Open Choice >Lessons from PrEP: A Qualitative Study Investigating How Clinical and Policy Experts Weigh Ethics and Evidence When Evaluating Preventive Medications for Use in Pregnant and Breastfeeding Women
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Lessons from PrEP: A Qualitative Study Investigating How Clinical and Policy Experts Weigh Ethics and Evidence When Evaluating Preventive Medications for Use in Pregnant and Breastfeeding Women

机译：PrEP的经验教训：一项定性研究研究临床和政策专家在评估孕妇和哺乳期妇女的预防性药物时如何权衡伦理和证据

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摘要

This study explored how multinational HIV experts weigh clinical, evidential, and ethical considerations regarding pre-exposure prophylaxis in pregnant/breastfeeding women. Semi-structured interviews were conducted with experts in HIV policy, research, treatment, and implementation from three global regions. A constant comparative approach identified major themes. Experts noted that exclusion of pregnant women from research limits evidence regarding risks/benefits, emphasizing that underinclusion of pregnant women in RCTs shifts the onus of evidence-building to clinical care. Experts discussed approaches for weighing evidence to make decisions, including triangulating evidence from sources other than RCTs. Likelihood and severity of disease strongly influenced decisions. Less effective interventions with limited fetal risk were preferred over interventions of uncertain safety, unless the disease was serious. Experts resisted the dichotomous choice between protecting maternal and fetal interests, arguing that these interests are intertwined and that more holistic approaches to maternal–fetal balance support greater inclusion of pregnant women in research.Electronic supplementary materialThe online version of this article (10.1007/s10461-018-2361-5) contains supplementary material, which is available to authorized users.
机译：这项研究探讨了跨国HIV专家如何权衡孕妇/母乳喂养妇女暴露前预防的临床，证据和道德考量。对来自三个全球地区的艾滋病毒政策，研究，治疗和实施方面的专家进行了半结构化访谈。不断的比较方法确定了主要主题。专家指出，将孕妇排除在研究范围之外限制了有关风险/益处的证据，强调指出，RCT中孕妇不足的情况将建立证据的责任转移到临床护理上。专家们讨论了权衡证据以做出决策的方法，包括对来自RCT以外来源的证据进行三角剖分。疾病的可能性和严重性强烈影响决策。除非疾病很严重，否则优先选择效率较低，胎儿风险有限的干预措施，而不是不确定安全性的干预措施。专家们反对在保护母体和胎儿利益之间进行二分法选择，认为这些利益是相互交织的，并且更全面的母子-胎儿平衡方法支持孕妇更多地参与研究。电子补充材料本文的在线版本（10.1007 / s10461- 018-2361-5）包含补充材料，授权用户可以使用。

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