التفاصيل البيبلوغرافية
| العنوان: |
Improving quality of the informed consent process: Developing an easy-to-read, multimodal, patient-centered format in a real-world setting. |
| المؤلفون: |
Lindsley, Karen A.1 (AUTHOR) klindsl@emory.edu |
| المصدر: |
Patient Education & Counseling. May2019, Vol. 102 Issue 5, p944-951. 8p. |
| مصطلحات موضوعية: |
*INFORMED consent (Medical law), *PEDIATRIC clinics, *COMPREHENSION, *QUALITY |
| مستخلص: |
Objective: To develop a patient-centered informed consent and assessment tool written at a 6th grade-level that is multimodal, affordable, transportable, and readily modifiable for protocol updates.Methods: This quality improvement initiative was performed in two phases on an actively-recruiting study at a pediatric diabetes clinic. In phase I, 38 volunteers underwent the standard-paper consent process, a comprehension assessment and provided feedback. Using feedback and the structure of the Plan-Do-Study-Act cycle a multimodal consent and assessment were developed. In phase II, volunteers were randomized to the standard (n = 25) or the multimodal consent (n = 25) and all completed the same comprehension assessment via touch-screen tablet. Primary outcomes were comparison of the individual and total comprehension assessment scores.Results: Total comprehension scores were higher in the multimodal versus the standard consent group (p < 0.001) and on the elements of benefits (p < 0.001), risks (p < 0.001), volunteerism (p < 0.012), results (p < 0.001), confidentiality (p < 0.004) and privacy (p < 0.001).Conclusion: A multimodal consent and assessment presented sequentially on a touch-screen tablet were patient-centered enhancements to standard consent.Practice Implications: Multimodal standardization of delivery with improved readability may strengthen the informed consent process. [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
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