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Digital tools in the informed consent process: a systematic review.
Francesco Gesualdo1, Margherita Daverio2, Laura Palazzani2
1Ospedale Pediatrico Bambino Gesù (OPBG), Piazza di Sant'Onofrio, 4, 00165, Rome, Italy. francesco.gesualdo@opbg.net.
BMC Medical Ethics
|February 28, 2021
Summary
Digital tools improve informed consent, enhancing patient understanding and satisfaction in clinical research and practice. Multimedia formats show greater impact than videos alone, though more research is needed.
Area of Science:
- Medical Informatics
- Patient Engagement
- Health Communication
Background:
- Informed consent is crucial for patient autonomy and safety.
- Digital technologies offer innovative formats for informed consent processes.
- Understanding patient comprehension, satisfaction, and participation is key.
Purpose of the Study:
- To systematically review the impact of digital tools on informed consent.
- To compare digital versus traditional informed consent methods in clinical research and practice.
- To evaluate different digital formats: video, non-interactive multimedia, and interactive multimedia.
Main Methods:
- Systematic review of studies from January 2012 to October 2020.
- Searched PubMed, EMBASE, and Cochrane databases using specific keywords.
- Included studies on digital informed consent for clinical research or procedures, categorizing interventions by format.
Main Results:
- 73 publications were included, analyzing interactive multimedia, non-interactive multimedia, and videos.
- Digital tools showed positive effects on at least one outcome in most studies for both clinical research (8/12) and procedures (21/26).
- Multimedia tools demonstrated a higher impact than video-only interventions.
Conclusions:
- Digital informed consent tools are not detrimental and generally beneficial.
- Interactive multimedia appears more effective than video-only formats.
- Further research with robust, standardized designs is necessary to fully assess the impact of digital informed consent.
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