From the Value Institute.
Systems Learning, Christiana Care Health System, Newark, Delaware.
J Patient Saf. 2021 Apr 1;17(3):e149-e154. doi: 10.1097/PTS.0000000000000310.
This study aimed to gather qualitative feedback on patient perceptions of informed consent forms and elicit recommendations to improve readability and utility for enhanced patient safety and engagement in shared decision making.
Sixty interviews in personal interviews were conducted consisting of a literacy and numeracy assessment, a comprehension quiz to assess retention of key information, and open-ended questions to determine reactions, clarity of information, and suggestions for improvement.
Although 68% of the participants had education beyond high school, many still missed comprehension questions and found the forms difficult to read. Recurrent suggestions included specific formatting changes to enhance readability, a need for additional sources of information, mixed attitudes toward inclusion of risk information, and the recognized importance of physician-patient conversations.
This study provides evidence from the patient perspective that consent forms are too complex and fail to achieve comprehension. Future studies should be conducted using patients' suggestions for form redesign and inclusion of supplemental educational tools to optimize communication and safety to achieve more informed health care decision making.
本研究旨在收集患者对知情同意书的看法的定性反馈,并提出建议以提高其可读性和实用性,从而增强患者安全性并促进共同决策。
采用个人访谈方式进行了 60 次访谈,包括读写能力评估、评估关键信息保留情况的理解测验以及开放式问题,以确定反应、信息清晰度和改进建议。
尽管 68%的参与者受过高中以上教育,但仍有许多人答错理解题,且发现这些表格难以阅读。反复提出的建议包括具体的格式更改以提高可读性、需要额外的信息来源、对纳入风险信息的混合态度,以及认识到医生-患者谈话的重要性。
本研究从患者角度提供了证据,表明同意书过于复杂且无法理解。未来的研究应使用患者对表格重新设计和补充教育工具的建议进行,以优化沟通和安全性,从而做出更明智的医疗保健决策。