用于评估选择性程序的知情同意文件质量的工具：开发和测试。,BMJ Open

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用于评估选择性程序的知情同意文件质量的工具：开发和测试。
BMJ Open ( IF 2.4 ) Pub Date : 2020-05-19 , DOI: 10.1136/bmjopen-2019-033297
Erica S Spatz _{1,

2} , Lisa G Suter _{2,

3} , Elizabeth George ₄ , Mallory Perez ₅ , Leslie Curry _{6,

7} , Vrunda Desai ₈ , Haikun Bao ₂ , Lori L Geary ₂ , Jeph Herrin ₉ , Zhenqiu Lin ₂ , Susannah M Bernheim _{2,

6,

10} , Harlan M Krumholz _{2,

9}

Affiliation

目标开发一种全国适用的工具，用于评估选择性程序的知情同意文件的质量。设计混合定性定量方法。设置与利益相关者召开了 7 次会议，以获取有关该工具的意见和反馈。参与者由来自全国不同地区的医师调查员、测量开发专家以及一个由九名患者和患者倡导者（护理人员、弱势人群倡导者和患者安全专家）组成的工作组。干预根据利益相关者的意见，我们确定了高质量知情同意文件的要素，汇总到三个领域：内容、演示和时间。基于这种对关键元素的综合分类，我们召集工作组就开发抽象工具提供意见，以分三个阶段评估知情同意文件的质量：(1) 选择最优先的元素作为工具中的项目进行操作；(2) 使用来自八家医院的符合条件的知情同意书样本，对工具进行迭代改进和测试；(3) 开发该工具的评分方法。最后，我们在另外 25 家医院的 250 份知情同意文件的子样本中测试了该工具的可靠性。结果评估知情同意文件质量的抽象工具。结果我们确定了知情同意质量的 53 个要素；其中，15 个被选为包含在抽象工具中的最高优先级，8 个是可行的测量。经过七个周期的调查项目迭代开发和测试，以及培训手册的开发和完善，两名受过培训的评分员在项目级别上达成了高度一致，从 92% 到 100%。结论我们确定了知情同意文件的关键质量要素，并实施了最高优先级要素来定义知情同意文件的最低标准。该工具是一个起点，可以使医院和其他提供者评估和提高知情同意的质量。结论我们确定了知情同意文件的关键质量要素，并实施了最高优先级要素来定义知情同意文件的最低标准。该工具是一个起点，可以使医院和其他提供者评估和提高知情同意的质量。结论我们确定了知情同意文件的关键质量要素，并实施了最高优先级要素来定义知情同意文件的最低标准。该工具是一个起点，可以使医院和其他提供者评估和提高知情同意的质量。

"点击查看英文标题和摘要"

An instrument for assessing the quality of informed consent documents for elective procedures: development and testing.

OBJECTIVE To develop a nationally applicable tool for assessing the quality of informed consent documents for elective procedures. DESIGN Mixed qualitative-quantitative approach. SETTING Convened seven meetings with stakeholders to obtain input and feedback on the tool. PARTICIPANTS Team of physician investigators, measure development experts, and a working group of nine patients and patient advocates (caregivers, advocates for vulnerable populations and patient safety experts) from different regions of the country. INTERVENTIONS With stakeholder input, we identified elements of high-quality informed consent documents, aggregated into three domains: content, presentation and timing. Based on this comprehensive taxonomy of key elements, we convened the working group to offer input on the development of an abstraction tool to assess the quality of informed consent documents in three phases: (1) selecting the highest-priority elements to be operationalised as items in the tool; (2) iteratively refining and testing the tool using a sample of qualifying informed consent documents from eight hospitals; and (3) developing a scoring approach for the tool. Finally, we tested the reliability of the tool in a subsample of 250 informed consent documents from 25 additional hospitals. OUTCOMES Abstraction tool to evaluate the quality of informed consent documents. RESULTS We identified 53 elements of informed consent quality; of these, 15 were selected as highest priority for inclusion in the abstraction tool and 8 were feasible to measure. After seven cycles of iterative development and testing of survey items, and development and refinement of a training manual, two trained raters achieved high item-level agreement, ranging from 92% to 100%. CONCLUSIONS We identified key quality elements of an informed consent document and operationalised the highest-priority elements to define a minimum standard for informed consent documents. This tool is a starting point that can enable hospitals and other providers to evaluate and improve the quality of informed consent.

更新日期：2020-05-19

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