Cohn Elizabeth Gross, Jia Haomiao, Smith Winifred Chapman, Erwin Katherine, Larson Elaine L
School of Nursing, Columbia University, New York, NY, USA.
Oncol Nurs Forum. 2011 Jul;38(4):417-22. doi: 10.1188/11.ONF.417-422.
PURPOSE/OBJECTIVES: To develop and assess the reliability and validity of an observational instrument, the Process and Quality of Informed Consent (P-QIC).
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.
A major urban teaching hospital in the northeastern region of the United States.
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.
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.
The essential elements of information and communication for informed consent.
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.
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.
The development of a validated observational instrument will allow investigators to assess the consent process more accurately and evaluate strategies designed to improve it.
目的/目标：开发并评估一种观察工具——知情同意过程与质量（P-QIC）的可靠性和有效性。
一项关于旨在测量临床研究中知情同意过程的质量和流程的工具的心理测量学的试点研究。该研究使用了专业拍摄的、模拟的同意过程，这些过程在流程和质量上有所不同。
美国东北部的一家大型城市教学医院。
63名参加健康相关项目的学生参与了心理测量测试，16名学生参与了重测信度测试，观察了5对研究者-参与者进行实际同意过程。
为了进行信度和效度测试，学生观看并对四段同意过程的录像模拟进行评分，这些模拟在过程和内容上有意有所不同，并使用拟议的工具对其进行评分。通过评分者观看录像模拟两次来建立重测信度。通过两名同时但独立的评分者观察实际同意过程来证明评分者间信度。
知情同意中信息和沟通的基本要素。
P-QIC的初步测试在模拟的标准化同意过程和医院环境中的实际同意过程中都显示出可靠且有效的心理测量特性。
P-QIC是一种易于使用的观察工具，可快速评估同意过程中的优势领域和需要改进的领域。它可用于新研究者或同意过程管理人员的初始培训以及知情同意的持续改进项目。
一种经过验证的观察工具的开发将使研究者能够更准确地评估同意过程，并评估旨在改进该过程的策略。
