Power Difference and Risk Perception: Mapping Vulnerability within the Decision Process of Pregnant Women towards Clinical Trial Participation in an Urban Middle-Income Setting
Power Difference and Risk Perception: Mapping Vulnerability within the Decision Process of Pregnant Women towards Clinical Trial Participation in an Urban Middle-Income Setting
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DOI：
10.1111/dewb.12132
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发表时间：
2018-06-01
影响因子：
2.2
通讯作者：
Klipstein-Grobusch, Kerstin
中科院分区：
文献类型：
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作者：
Den hollander, Geerte C.;Browne, Joyce L.;Klipstein-Grobusch, Kerstin
为了解决低收入和中等收入国家 (LMIC) 孕产妇发病率和死亡率的负担，针对这些地区孕妇的研究越来越普遍。中低收入国家的孕妇可能会因同意参加临床试验而感到脆弱。为了认识到可能存在的脆弱性层次，本研究旨在确定影响城市中等收入环境中孕妇参与临床试验决策过程的因素。这项定性研究在加纳阿克拉的一家地区医院采用了参与观察、深入访谈以及与符合试验参与资格的医务人员和孕妇进行焦点小组讨论的方式。除了缺乏对现代科学概念的熟悉之外，还确定了影响决策过程的具体因素。其中包括医疗服务提供者和患者之间巨大的权力差异，以及在宗教背景和权威塑造的背景下通过风险管理责任的外化而对风险的不同看法。此外，还观察到治疗误解。这些因素的结合导致女性依赖医疗专业人士的意见，而不是受自己参与动机的指导。尽管（孕妇）本身不应该贴上易受伤害的标签，但这项研究表明，有一些因素会影响孕妇参与中低收入国家试验的决策过程，从而导致易受伤害。识别可能造成脆弱性的特定背景因素有助于以文化上可行的方式调整设计和开展研究。
To address the burden of maternal morbidity and mortality in low- and middle-income countries (LMICs), research with pregnant women in these settings is increasingly common. Pregnant women in LMIC-context may experience vulnerability related to giving consent to participate in a clinical trial. To recognize possible layers of vulnerability this study aims to identify factors that influence the decision process towards clinical trial participation of pregnant women in an urban middle-income setting. This qualitative research used participant observation, in-depth interviews, and focus group discussion with medical staff and pregnant women eligible for trial participation, at a regional hospital in Accra, Ghana. Besides lack of familiarity with modern scientific concepts, specific factors influencing the decision-making process were identified. These include a wide power difference between health provider and patient, and a different perception of risk through externalization of responsibility of risk management within a religious context as well as a context shaped by authority. Also, therapeutic misconception was observed. The combination of these factors ensued women to rely on the opinion of the medical professional, rather than being guided by their own motivation to participation. Although being a (pregnant) woman per se should not render the label of being vulnerable, this study shows there are factors that influence the decision process of pregnant woman towards trial participation in a LMIC context that can result in vulnerability. The identification of context-specific factors that can create vulnerability facilitates adaptation of the design and conduct of research in a culturally competent manner.