Objective: 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.
Methods: 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.
Results: 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.
Conclusions: 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.
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