Measuring the Process and Quality of Informed Consent for Clinical Research: Development and Testing
Measuring the Process and Quality of Informed Consent for Clinical Research: Development and Testing
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DOI：
10.1188/11.onf.417-422
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发表时间：
2011-07-01
影响因子：
1.9
通讯作者：
Larson, Elaine L.
中科院分区：
文献类型：
--
作者：
Cohn, Elizabeth Gross;Jia, Haomiao;Larson, Elaine L.
目的/目标：开发和评估一种观察工具的可靠性和有效性，即知情同意的过程和质量（P-QIC）。设计：一项旨在衡量临床研究中知情同意遭遇的质量和过程的工具的心理测量学的试点研究。这项研究使用了专业拍摄的、模拟的同意接触，设计的过程和质量各不相同。地点：美国东北部一所主要的城市教学医院。样本：参加健康相关项目的63名学生参加了心理测量测试，16名学生参加了重测信度测试，并观察了5名调查者-参与者对实际同意接触的情况。方法：为了进行信度和效度测试，学生观看并评估了四次有意在过程和内容上有所不同的同意遭遇的模拟录像，并用所提出的工具对其进行了评估。重测信度是由评分者观看两次模拟录像来确定的。评估者之间的信度通过两个同时但独立的评估者观察实际的同意遭遇来证明。主要研究变量：知情同意的信息和沟通的基本要素。研究结果：P-QIC的初步测试在模拟标准化同意接触和医院环境中的实际同意接触中都显示了可靠和有效的心理测量特性。结论：P-QIC是一种易于使用的观察工具，可以快速评估同意遭遇的优势领域和需要改进的领域。它可以用于新调查员或同意管理员的初始培训以及正在进行的知情同意改进计划。对护理的影响：开发一种有效的观察工具将使研究人员能够更多地评估同意过程，并评估旨在改进同意过程的策略。
Purpose/Objectives: To develop and assess the reliability and validity of an observational instrument, the Process and Quality of Informed Consent (P-QIC).Design: A pilot study of the psychometrics of a tool designed to measure the quality and process of the informed consent encounter in clinical research. The study used professionally filmed, simulated consent encounters designed to vary in process and quality.Setting: A major urban teaching hospital in the northeastern region of the United States.Sample: 63 students enrolled in health-related programs participated in psychometric testing, 16 students participated in test-retest reliability, and 5 investigator-participant dyads were observed for the actual consent encounters.Methods: For reliability and validity testing, students watched and rated videotaped simulations of four consent encounters intentionally varied in process and content and rated them with the proposed instrument. Test-retest reliability was established by raters watching the videotaped simulations twice. Inter-rater reliability was demonstrated by two simultaneous but independent raters observing an actual consent encounter.Main Research Variables: The essential elements of information and communication for informed consent.Findings: The initial testing of the P-QIC demonstrated reliable and valid psychometric properties in both the simulated standardized consent encounters and actual consent encounters in the hospital setting.Conclusions: The P-QIC is an easy-to-use observational tool that provides a quick assessment of the areas of strength and areas that need improvement in a consent encounter. It can be used in the initial trainings of new investigators or consent administrators and in ongoing programs of improvement for informed consent.Implications for Nursing: The development of a validated observational instrument will allow investigators to assess the consent process more and evaluate strategies designed to improve it.