Patient reactions to confidentiality, liability, and financial aspects of informed consent in cardiology research.
Patient reactions to confidentiality, liability, and financial aspects of informed consent in cardiology research.
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患者对心脏病学研究中知情同意的保密性、责任和财务方面的反应。
DOI：
10.1161/circoutcomes.109.849273
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发表时间：
2010
期刊：
影响因子：
--
通讯作者：
Weinfurt,KevinP
中科院分区：
文献类型：
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作者：
Fortune-Greeley,AliceK;Hardy,NChantelle;Lin,Li;Friedman,JoëlleY;Lawlor,JaniceS;Muhlbaier,LawrenceH;Hall,MarkA;Schulman,KevinA;Sugarman,Jeremy;Weinfurt,KevinP
背景——虽然知情同意过程应该帮助潜在的研究参与者就参与研究做出知情和自愿的决定，但人们对参与者对知情同意文件中的语言如何反应以及他们的反应是否与他们参加临床试验的意愿相关知之甚少。我们研究了患者对标准知情同意语言的反应与他们参加假设性临床试验的意愿之间的关系。方法和结果——我们模拟了一项假设性心脏病学临床试验的同意过程，该试验在一家大型学术医疗中心的心血管医学门诊有 470 名患者参与。我们分析了参与者在访谈中对知情同意文件各部分提出的自发评论和问题。很少有参与者提出积极的评论。参与者对风险、研究目的或方案以及伤害支付等部分做出了最负面的评论。对任何部分的负面反应都与参与临床试验的可能性较低有关。使用多变量模型，我们发现患者权利、财务披露和保密部分的负面反应预示着参与意愿（P<0.001）。结论——认识到引起潜在研究参与者问题和担忧的知情同意要素可能有助于研究者以减少担忧或增加参与者理解的方式设计临床研究试验和模型语言，从而增强研究的知情同意。
Background—Although the informed consent process is supposed to help potential research participants make informed and voluntary decisions about participating in research, little is known about how participants react to language in the informed consent document and whether their reactions are related to their willingness to enroll in clinical trials. We examined the relationship between patients’ reactions to standard informed consent language and their willingness to participate in a hypothetical clinical trial.Methods and Results—We simulated the consent process for a hypothetical cardiology clinical trial with 470 patients in an outpatient cardiovascular medicine clinic at a large academic medical center. We analyzed the spontaneous comments and questions that participants made during the interviews about each section of the informed consent document. Few participants made positive comments. Participants made the most negative comments about the sections on risks, study purpose or protocol, and payment for injury. Having a negative reaction to any section was associated with a lower likelihood of participating in the clinical trial. Using a multivariable model, we found that negative reactions in the patient rights, financial disclosure, and confidentiality sections predicted willingness to participate (P<0.001).Conclusions—Recognizing elements of informed consent that elicit questions and concerns from potential research participants may help investigators design clinical research trials and model language in a way that reduces concerns or increases participant understanding, thereby enhancing informed consent for research.