An instrument for assessing the quality of informed consent documents for elective procedures: development and testing.
An instrument for assessing the quality of informed consent documents for elective procedures: development and testing.
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用于评估选择性程序知情同意文件质量的工具：开发和测试。
DOI：
10.1136/bmjopen-2019-033297
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发表时间：
2020
期刊：
影响因子：
2.9
通讯作者：
Krumholz,HarlanM
中科院分区：
文献类型：
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作者：
Spatz,EricaS;Suter,LisaG;George,Elizabeth;Perez,Mallory;Curry,Leslie;Desai,Vrunda;Bao,Haikun;Geary,LoriL;Herrin,Jeph;Lin,Zhenqiu;Bernheim,SusannahM;Krumholz,HarlanM
目的开发一个全国适用的工具，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，以获得对该工具的输入和反馈。医师研究小组，测量开发专家，以及9名患者和患者倡导者组成的工作组干预措施在利益相关者的投入下，我们确定了高质量知情同意文件的要素，汇总为三个领域：内容、介绍和时间安排。基于对关键要素的全面分类，我们召集了工作组，为开发抽象工具提供投入，以评估知情同意文件的质量，分为三个阶段：（1）选择最高优先级的要素作为工具中的项目;（2）使用来自八家医院的合格知情同意文件样本反复完善和测试工具;以及（3）为工具开发评分方法。最后，我们测试了该工具的可靠性，在子样本的250知情同意文件从另外25 hospital.OutcomesAbstraction工具，以评估知情同意documents.ResultsWe的质量确定了53个要素的知情同意质量;其中，15被选为最高优先级的抽象工具，8是可行的措施。经过七个周期的迭代开发和测试的调查项目，开发和完善的培训手册，两个训练有素的评分员实现了高项目级协议，从92%到100%.ConclusionsWe确定了知情同意书的关键质量要素和操作的最高优先级的元素，以定义最低标准的知情同意书。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。
ObjectiveTo develop a nationally applicable tool for assessing the quality of informed consent documents for elective procedures.DesignMixed qualitative-quantitative approach.SettingConvened seven meetings with stakeholders to obtain input and feedback on the tool.ParticipantsTeam 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.InterventionsWith 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.OutcomesAbstraction tool to evaluate the quality of informed consent documents.ResultsWe 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%.ConclusionsWe 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.