非专业人士对急诊产科和新生儿护理研究要求的认知。

Lay persons' perception of the requirements for research in emergency obstetric and newborn care.

作者信息

Kaye Dan Kabonge

机构信息

Department of Obstetrics and Gynecology, College of Health Sciences, Makerere University, P.O. Box 7072, Kampala, Uganda.

Berman Institute of Bioethics, Johns Hopkins University, Deering Hall, 1809 Ashland Avenue, Baltimore, MD, 21205, USA.

出版信息

BMC Med Ethics. 2021 Jan 2;22(1):1. doi: 10.1186/s12910-020-00568-1.

DOI:10.1186/s12910-020-00568-1

PMID:33388052

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7777394/

Abstract

BACKGROUND

Factors that could potentially act as facilitators and barriers to successful recruitment strategies in perinatal clinical trials are not well documented. The objective was to assess lay persons' understanding of the informed consent for randomized clinical trial in emergency obstetric and newborn care.

METHODS

This was a qualitative study conducted among survivors of severe obstetric complications who were attending the post-natal clinic of Kawempe National Referral Hospital, Uganda, 6-8 weeks after surviving severe obstetric complications during pregnancy or childbirth. The study that involved 18 in-depth interviews was conducted from June 1, 2019 to July 6, 2019. The issues explored included perceptions of the purpose and necessity to conduct such research how research-related information would be disclosed, and what could be the potential benefits and risks of participation. The data was analyzed by thematic analysis.

RESULTS

Respondents felt that research was necessary to investigate the cause, prevention or complications of an illness, especially as much was known about some pregnancy and newborn complications. Most believed that the emergency contexts affects whether and what prospective participants may understand if information about research was disclosed. Whereas they did not see the value of procedures like randomization, they felt that if these and any other procedures necessary should be done transparently and fairly. The decisions to participate would significantly be influenced by possibility of risk to the unborn baby or the newborn. Solidarity was an important influence on decision-making.

CONCLUSIONS

Respondents valued participation in RCTs in emergency obstetric and newborn care. However, they expressed concerns and valued openness, transparency and accountability with regard to how clinical trials information is disclosed and the decision-making process for clinical trial participation. While autonomy and solidarity are contradictory values, they complement each other during decision-making for informed consent.

摘要

背景

在围产期临床试验中，可能对成功招募策略起到促进或阻碍作用的因素尚无充分记录。目的是评估外行人对紧急产科和新生儿护理随机临床试验知情同意书的理解。

方法

这是一项定性研究，研究对象为严重产科并发症幸存者，他们在乌干达卡韦姆佩国家转诊医院产后诊所就诊，这些幸存者在孕期或分娩时经历严重产科并发症后6至8周。2019年6月1日至2019年7月6日进行了18次深入访谈。探讨的问题包括对开展此类研究的目的和必要性的看法、如何披露与研究相关的信息，以及参与研究可能带来的潜在益处和风险。采用主题分析法对数据进行分析。

结果

受访者认为有必要开展研究以调查疾病的病因、预防方法或并发症，尤其是对于一些妊娠和新生儿并发症，人们了解得还不够多。大多数人认为紧急情况会影响潜在参与者是否以及能否理解所披露的研究信息。虽然他们认为随机分组等程序没有价值，但他们觉得如果要进行这些及其他任何必要程序，应该做到透明、公平。参与的决定将很大程度上受到未出生婴儿或新生儿面临风险可能性的影响。团结是决策的一个重要影响因素。