Improving quality of the informed consent process: Developing an easy-to-read, multimodal, patient-centered format in a real-world setting.

Only 50 volunteers were randomized at one pediatric diabetes clinic, and they were recruited as a convenience sample, so the results may not apply to other patients, clinics, or consent situations. Parents aged 37 and older made up 95% of volunteers, and adult males were underrepresented, so the finding may not hold for younger adults or siblings. The consent sessions were not timed, so extra attention or interaction during the multimodal process may have contributed to the higher scores. The multimodal group had higher education than the standard group, though this was not statistically significant, which could have helped their comprehension scores. All volunteers later received the standard paper consent with interactive review, and scores were not repeated, so the video advantage may not have persisted. The multimodal group received several elements together: a narrated video, touch-screen tablet use, and sixth-grade text. The study cannot show which element caused the better scores.

No author conflicts of interest are stated in the supplied text. The article is tagged as supported by NIH extramural research.

Do not conclude that a video consent will improve patient care or health outcomes. The study measured only comprehension test scores in a small research-consent setting, and the multimodal group received a narrated video, touch-screen tablet use, and sixth-grade text together, so the study cannot show which component caused the higher scores.