The reality of informed consent: empirical studies on patient comprehension-systematic review.
The reality of informed consent: empirical studies on patient comprehension-systematic review.
复制标题
知情同意的现实：患者理解的实证研究-系统评价。
DOI：
10.1186/s13063-020-04969-w
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发表时间：
2021-01-14
期刊：
影响因子：
2.5
通讯作者：
Smilowska K
中科院分区：
文献类型：
--
作者：
Pietrzykowski T;Smilowska K
知情同意是当代基于医疗实践的一个基本概念，有助于医生和患者之间关系的共同决策模式。因此，患者能够理解他们所给予的同意的程度对于今天所追求的医学的伦理可行性至关重要。然而，关于患者对知情同意书基本组成部分的理解的研究表明，他们的理解水平是有限的。对PubMed和Web of Science数据库进行了系统检索，以识别关于知情同意的文献，特别是患者对特定知情同意组成部分的理解。共检索到14篇相关文章。在大多数研究中，很少有临床试验参与者正确回答了检查他们对自己同意的内容的意识的项目。参与者对自愿参与、设盲（不包括研究者设盲的知识）和随时退出的自由表现出最高水平的理解（超过50%）。只有少数患者表现出对安慰剂概念、随机化、安全性问题、风险和副作用的理解。我们发现，参与者对基本知情同意组成部分的理解很低，这是令人担忧的，因为这种缺乏理解破坏了当代临床试验实践的伦理支柱，并质疑患者充分和真正参与共同医疗决策过程的可行性。
Informed consent is a basic concept of contemporary, autonomy-based medical practice and facilitates a shared decision-making model for relations between physicians and patients. Thus, the extent to which patients can comprehend the consent they grant is essential to the ethical viability of medicine as it is pursued today. However, research on patients’ comprehension of an informed consent’s basic components shows that their level of understanding is limited. Systemic searches of the PubMed and Web of Science databases were performed to identify the literature on informed consent, specifically patients’ comprehension of specific informed consent components. In total, 14 relevant articles were retrieved. In most studies, few clinical trial participants correctly responded to items that examined their awareness of what they consented to. Participants demonstrated the highest level of understanding (over 50%) regarding voluntary participation, blinding (excluding knowledge about investigators’ blinding), and freedom to withdraw at any time. Only a small minority of patients demonstrated comprehension of placebo concepts, randomisation, safety issues, risks, and side effects. We found that participants’ comprehension of fundamental informed consent components was low, which is worrisome because this lack of understanding undermines an ethical pillar of contemporary clinical trial practice and questions the viability of patients’ full and genuine involvement in a shared medical decision-making process.
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影响因子：
2.9
作者：
Page MJ;McKenzie JE;Higgins JPT
通讯作者：
Higgins JPT
影响因子：
3.7
作者：
Chaisson, Lelia H.;Kass, Nancy E.;Samandari, Taraz
通讯作者：
Samandari, Taraz
影响因子：
2.2
作者：
Bertoli, Ana M.;Strusberg, Ingrid;Strusberg, Alberto M.
通讯作者：
Strusberg, Alberto M.
影响因子：
2.7
作者：
Krosin, Michael T.;Klitzman, Robert;Ranney, Megan L.
通讯作者：
Ranney, Megan L.
DOI：
10.1002/art.11057
发表时间：
2003-06-15
期刊：
ARTHRITIS & RHEUMATISM-ARTHRITIS CARE & RESEARCH
影响因子：
--
作者：
Criscione, LG;Sugarman, J;St Clair, EW
通讯作者：
St Clair, EW