Stephanie A Kraft1, Melissa Constantine2, David Magnus3, Kathryn M Porter1, Sandra Soo-Jin Lee3, Michael Green4, Nancy E Kass5, Benjamin S Wilfond1, Mildred K Cho3. 1. 1 Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, WA, USA. 2. 2 Division of Health Policy and Management, University of Minnesota, Minneapolis, MN, USA. 3. 3 Stanford Center for Biomedical Ethics, Stanford University School of Medicine, Stanford, CA, USA. 4. 4 Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, PA, USA. 5. 5 Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA.
Abstract
BACKGROUND/AIMS: Participant understanding is a key element of informed consent for enrollment in research. However, participants often do not understand the nature, risks, benefits, or design of the studies in which they take part. Research on medical practices, which studies standard interventions rather than new treatments, has the potential to be especially confusing to participants because it is embedded within usual clinical care. Our objective in this randomized study was to compare the ability of a range of multimedia informational aids to improve participant understanding in the context of research on medical practices. METHODS: We administered a web-based survey to members of a proprietary online panel sample selected to match national US demographics. Respondents were randomized to one of five arms: four content-equivalent informational aids (animated videos, slideshows with voice-over, comics, and text) and one no-intervention control. We measured knowledge of research on medical practices using a summary knowledge score from 10 questions based on the content of the informational aids. We used analysis of variance and paired t-tests to compare knowledge scores between arms. RESULTS: There were 1500 completed surveys (300 in each arm). Mean knowledge scores were highest for the slideshows with voice-over (65.7%), followed by the animated videos (62.7%), comics (60.7%), text (57.2%), and control (50.3%). Differences between arms were statistically significant except between the slideshows with voice-over and animated videos and between the animated videos and comics. Informational aids that included an audio component (animated videos and slideshows with voice-over) had higher knowledge scores than those without an audio component (64.2% vs 59.0%, p < .0001). There was no difference between informational aids with a character-driven story component (animated videos and comics) and those without. CONCLUSION: Our results show that simple multimedia aids that use a dual-channel approach, such as voice-over with visual reinforcement, can improve participant knowledge more effectively than text alone. However, the relatively low knowledge scores suggest that targeted informational aids may be needed to teach some particularly challenging concepts. Nonetheless, our results demonstrate the potential to improve informed consent for research on medical practices using multimedia aids that include simplified language and visual metaphors.
RCT Entities:
BACKGROUND/AIMS: Participant understanding is a key element of informed consent for enrollment in research. However, participants often do not understand the nature, risks, benefits, or design of the studies in which they take part. Research on medical practices, which studies standard interventions rather than new treatments, has the potential to be especially confusing to participants because it is embedded within usual clinical care. Our objective in this randomized study was to compare the ability of a range of multimedia informational aids to improve participant understanding in the context of research on medical practices. METHODS: We administered a web-based survey to members of a proprietary online panel sample selected to match national US demographics. Respondents were randomized to one of five arms: four content-equivalent informational aids (animated videos, slideshows with voice-over, comics, and text) and one no-intervention control. We measured knowledge of research on medical practices using a summary knowledge score from 10 questions based on the content of the informational aids. We used analysis of variance and paired t-tests to compare knowledge scores between arms. RESULTS: There were 1500 completed surveys (300 in each arm). Mean knowledge scores were highest for the slideshows with voice-over (65.7%), followed by the animated videos (62.7%), comics (60.7%), text (57.2%), and control (50.3%). Differences between arms were statistically significant except between the slideshows with voice-over and animated videos and between the animated videos and comics. Informational aids that included an audio component (animated videos and slideshows with voice-over) had higher knowledge scores than those without an audio component (64.2% vs 59.0%, p < .0001). There was no difference between informational aids with a character-driven story component (animated videos and comics) and those without. CONCLUSION: Our results show that simple multimedia aids that use a dual-channel approach, such as voice-over with visual reinforcement, can improve participant knowledge more effectively than text alone. However, the relatively low knowledge scores suggest that targeted informational aids may be needed to teach some particularly challenging concepts. Nonetheless, our results demonstrate the potential to improve informed consent for research on medical practices using multimedia aids that include simplified language and visual metaphors.
Entities:
Keywords:
Research on medical practices; comparative effectiveness research; informed consent; multimedia; pragmatic clinical trials; research ethics; video
Authors: Patricia Agre; Frances A Campbell; Barbara D Goldman; Maria L Boccia; Nancy Kass; Laurence B McCullough; Jon F Merz; Suzanne M Miller; Jim Mintz; Bruce Rapkin; Jeremy Sugarman; James Sorenson; Donna Wirshing Journal: IRB Date: 2003 Sep-Oct
Authors: Brianna Hoffner; Susan Bauer-Wu; Suzanne Hitchcock-Bryan; Mark Powell; Andrew Wolanski; Steven Joffe Journal: Cancer Date: 2011-08-25 Impact factor: 6.860
Authors: Sheila T Murphy; Lauren B Frank; Joyee S Chatterjee; Meghan B Moran; Nan Zhao; Paula Amezola de Herrera; Lourdes A Baezconde-Garbanati Journal: Am J Public Health Date: 2015-04-23 Impact factor: 9.308
Authors: Stephanie Alessi Kraft; Mildred K Cho; Melissa Constantine; Sandra Soo-Jin Lee; Maureen Kelley; Diane Korngiebel; Cyan James; Ellen Kuwana; Adrienne Meyer; Kathryn Porter; Douglas Diekema; Alexander M Capron; Radica Alicic; Benjamin S Wilfond; David Magnus Journal: Clin Trials Date: 2016-06-01 Impact factor: 2.486
Authors: Lauren A McCormack; Amanda Wylie; Rebecca Moultrie; Robert D Furberg; Anne C Wheeler; Katherine Treiman; Donald B Bailey; Melissa Raspa Journal: PLoS One Date: 2019-10-23 Impact factor: 3.240
Authors: Holly L Peay; Angela You Gwaltney; Rebecca Moultrie; Heidi Cope; Beth Lincoln- Boyea; Katherine Ackerman Porter; Martin Duparc; Amir A Alexander; Barbara B Biesecker; Aminah Isiaq; Jennifer Check; Lisa Gehtland; Donald B Bailey; Nancy M P King Journal: Front Genet Date: 2022-05-12 Impact factor: 4.772
Authors: Susan E Morgan; Wei Peng; Aurora Occa; Bingjing Mao; Soroya McFarlane; Gilles Grinfeder; Barbara Millet; Margaret M Byrne Journal: J Cancer Educ Date: 2022-02 Impact factor: 1.771