From the Patient Perspective, Consent Forms Fall Short of Providing Information to Guide Decision Making

Abstract

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.

Reaffirming and Clarifying the American Society of Clinical Oncology’s Policy Statement on the Critical Role of Phase I Trials in Cancer Research and Treatment

“…These documents should be written at an 8th grade reading level, because many current forms are long, complex, and highly technical. 9 ASCO continually advocates that informed consent forms be simplified to optimize comprehensibility and clarity, reduce intimidating language, and place potential benefits and risks in a proper context. 10 In addition, it is critical that clinicians discuss this information in the informed consent process with the goal of ensuring that potential trial participants and their family members make fully informed decisions about whether to enroll in the trial.…”

The Appropriateness of Language Found in Research Consent Form Templates: A Computational Linguistic Analysis

“…Research demonstrates that some participants have a level of understanding about the purposes and risks of the trial that compromises their consent [ 23 – 25 ]. Patients themselves sometimes feel that the study consent form has not given them a satisfactory level of understanding [ 26 , 27 ]. The promotion of consent forms with inappropriately complex language through the use of poorly designed templates may contribute to these problems.…”

Optimised patient information materials and recruitment to a study of behavioural activation in older adults: an embedded study within a trial

“…Potential participants in randomised controlled trials are given information that is often long, technical and difficult to navigate [1][2][3] . Consequently, they may lack understanding of important details about the trial 1,4,5 , which limits their ability to make an informed decision about consent.…”