Table 3.

Results from trials of interactive digital interventions to improve patient comprehension in informed consent

Source	Study country	N	Mean patient age (and range if specified)	Patients’ education	Procedure	Intervention	Elements of patient comprehension assessed	Comprehension assessment tool	Timing of patient comprehension assessment relative to informed consent consultation*	Risk of bias for patient comprehension outcome†	Results	Group favored‡
Bethune et al. (2018)	Canada	38	62.2 y	Not specified	Lumbar spine or cervical spine decompression for degenerative disease, craniotomy for brain tumor, trigeminal neuralgia treatment	E-book interactive multimedia application lasting 7-10 minutes (specific interactive features not specified, pilot tested among “student volunteers with no medical training”) with written explanations, pictures, and short videos relevant to the specific procedure provided on an electronic tablet prior to a standard informed consent discussion with a surgeon versus standard consent discussion with a surgeon alone (control)	Risks, alternatives, general knowledge about procedure	14-item questionnaire adapted from a validated measure with each item rated on a scale of 0-3 (max score 42)	Immediately	Some concerns for bias	23.2 out of 42 (SD 4.9) intervention vs. 20.2 out of 42 (SD 4.0) control, P = 0.02	Intervention
Gordon et al. (2017)	USA	288	51 y (range 22 – 77)	72.2% less than college, 27.8% BA or higher	Kidney transplant with increased risk donors	“Inform Me” electronic tablet application provided (average duration 47 minutes) in addition to routine transplant education versus routine transplant education alone (control); application utilized “low literacy and low numeracy messages” and adaptive learning to personalize educational content in 5 interactive chapters with textual explanations, graphics, videos, photographs and test questions between chapters (based on accuracy of answers the application presented additional information specific to incorrect answers, correct answers were required to progress to the next chapter)	Unclear/ not specified	31-item multiple choice test completed electronically by the intervention group and on paper by the control group	Immediately and delayed	Some concerns for bias	Immediate: mean score 20.69 out of 31 intervention vs. 13.94 out of 31 control, P <0.001 Delayed: mean score 17.94 out of 31 intervention vs. 14.7 out of 31 control, P <0.001	Intervention
Kinman et al. (2017)	USA	60	55.6 y	61.4% completed high school, 19.3% some college or trade school, 17.5% some graduate school	Pelvic organ prolapse surgery	Interactive electronic tablet application (“developed and internally validated” at the study institution after being administered to “a separate group of 32 patients from the same clinical setting” as study participants) with illustrations of a female pelvis with normal anatomy, examples of pelvic organ prolapse, and possible surgical treatments for prolapse plus standard consent (verbal consent using a “standardized protocol script” plus time to ask questions plus signing of consent document) versus standard consent alone (control)	Risks, alternatives, general knowledge about procedure	20-item validated multiple choice questionnaire	Immediately and delayed	Some concerns for bias	Immediate: “no significant difference in mean improvement,” P = 0.22 Delayed: significant decrease in score in intervention group only, P < 0.01	Immediate: neither, delayed: control
Wollinger et al. (2012)	Austria	90	73.7 y (range 48 – 94)	Not specified	Cataract surgery	“CatInfo” computer-based program with touch-screen monitor and headphones using a stepwise approach through modules via a “traffic light” system (patients instructed to select green if they understood everything within the module, yellow for further questions to discuss with physician, and red to repeat the module) in addition to standard face-to-face consent versus standard face-to-face consent plus a short sham computer presentation (control)	Risks, general knowledge about procedure	Validated 23-item multiple choice questionnaire	Not specified	Some concerns for bias	Questions correctly answered 15 out of 19 intervention vs. 12 out of 19 control, P < 0.01	Intervention
Fraval et al. (2015)	Australia	211	54.0 y	Not specified	Total knee arthroplasty, total hip arthroplasty, knee arthroscopy, shoulder arthroscopy and anterior cruciate ligament reconstruction	Online education resource developed by the Western Health Orthopaedic department (www.orthoanswer.org, no commercial funding, website contributed to by “orthopaedic residents and registrars, physiotherapists, occupational therapists and medical students” and “reviewed by consultant orthopaedic surgeons”) for patients with a 5th grade reading level or in addition to standard discussion with the treating surgeon versus standard discussion with the treating surgeon alone (control)	Risks, benefits, alternatives, general knowledge about procedure	Operation-specific questionnaire adapted from a validated survey	Immediately	Some concerns for bias	Average correct answers 69.25% intervention vs. 47.38% control, P < 0.01	Intervention
Tait et al. (2009)	USA	135	60.5 y	26.7% ≤ high school, 23.0% some college or trade school, 43.0% ≥ bachelor’s degree	Diagnostic cardiac catheterization	10-12 minute interactive computer program with text, narration, 2D and 3D graphics, and ability to type in questions at any point to be relayed to the cardiologist, and a short optional quiz to ascertain understanding of the key elements of the procedure (content based on existing consent documents, relevant literature, and input from cardiologists and computer graphic designers reviewed by cardiologists, “informed consent experts,” nurses, students and patients prior to use) versus standard verbal and written informed consent with a cardiology fellow or physician’s assistant (control)	Risks, benefits, alternatives, general knowledge about procedure	Semi-structured interview with 6 responses written down verbatim and scored from 0 (no understanding) to 2 (complete understanding), based on the validated Deaconess Informed Consent Comprehension Test	Delayed	Some concerns for bias	Understanding score 9.3 out of 12 (SD 2.2) intervention vs. 8.1 out of 12 (SD 2.3) control immediately post procedure, P < 0.05 Understanding score 8.6 out of 12 (SD 2.7) intervention vs. 7.9 out of 12 (SD 2.2) control 2 weeks post procedure, “not statistically significant” (no P value given)	Intervention
Tait et al. (2014)	USA	151	61.9 y	27.8% ≤ high school graduate, 28.4% some college or trade school, 41.7% ≥ Bachelor’s degree	Diagnostic cardiac catheterization	10-12 minute electronic tablet interactive multimedia program with in-line exercises and corrected feedback, 2D and 3D computer models, dynamic visualization of anatomical and physiologic functions, informational text inserts, voice over, and ability to click icons for additional information (content based on “information from medical textbooks, media, and expert opinion) versus standard verbal and written informed consent information (control)	Risks, benefits, alternatives, general knowledge about procedure	Semi-structured interview with 6 responses written down verbatim and scored from 0 (no understanding) to 2 (complete understanding), based on the validated Deaconess Informed Consent Comprehension Test	Delayed	Some concerns of bias	Understanding score 8.3 out of 12 (SD 2.4) intervention vs. 7.4 out of 12 (SD 2.5) control immediately post procedure, P < 0.05 Understanding score 7.6 out of 12 (SD 2.2) intervention vs. 6.6 out of 12 (SD 2.5) control 2 weeks post procedure, P < 0.05	Intervention
Heller et al. (2008)	USA	133	47.0 y	46.6% some college or less, 50.4% college or more	Breast reconstruction	Menu-driven interactive software program with animated graphics, patient testimonials, before-and-after photographs, and video explanations from plastic surgeons and clinical specialists (content selected in light of focus groups and faculty discussion at the University of Texas M.R. Anderson Cancer Center) in addition to routine education versus routine education alone (control)	General knowledge about procedure	12-item multiple choice questionnaire	Delayed	High risk of bias	Mean increase from baseline 14% intervention vs. 8% control, P = 0.02	Intervention
Gyomber et al. (2010)	Australia	40	61 y	27.5% did not complete high school, 42.5% completed high school, 30% tertiary education or technical school	Radical prostatectomy	Interactive multimedia PowerPoint presentation containing animated information and multiple-choice questions (developed with input from urologists, nurses, and patients and tested on 5 volunteers) probing understanding of key points at a 7th grade reading level; progression through the module required a correct response to each question, incorrect responses prompted a review of the information before repeating the question versus standard consent consisting of a verbal discussion with a doctor and nurse at a pre-admission clinic using a checklist of issues to cover and an informational booklet provided 3 weeks prior to the consent discussion and again at the time of the consent discussion (control) Groups were crossed over immediately after consent and initial evaluation of comprehension	Risks, benefits, alternatives, general knowledge about procedure	26-item multiple choice and true/false questionnaire	Immediately	High risk of bias	Average score 78% intervention vs. 57% control, P < 0.001 On crossover, control improved on average by 11% while intervention group was unchanged, P < 0.05	Intervention
Kim et al. (2018)	South Korea	60	Not specified	5% less than middle school, 35% completed high school, 60% college/university	Nasal bone fracture reduction surgery	Mobile phone application with information about the surgery, post op management, and alerts such as “nasal packing will be removed today” in addition to traditional informed consent (“verbal descriptions and paper permission”) versus traditional informed consent alone (control)	Risks	Number of recalled surgical risks out of 6	Delayed	High risk of bias	1.72 out of 6 (SD 0.52) intervention vs. 1.49 out of 6 (SD 0.57) control, P = 0.047	Intervention
Siu et al. (2015)	Canada	50	48.3 y (range 21 – 85)	20% did not complete high school, 46% some college or trade school, 34% Bachelor’s or higher	Endoscopic sinus surgery	6-minute interactive computer multimedia module at an 8th grade reading level based on information from current standardized informed consent documents with voice-over, images, figures, animations, and knowledge checkpoints with quiz-type questions, in addition to routine verbal informed consent versus routine verbal informed consent alone (control)	Risks	Immediate: “participants were asked to complete a written questionnaire listing as many of the risks discussed at the consultation visit that they could recall.” Delayed: “patients were asked to recall as many of the risks of the procedure as possible” via telephone	Immediately and delayed	High risk of bias	Immediate: risks recalled 4.88 intervention vs. 3.5 control, P = 0.0036 Delayed: risks recalled 3.2 intervention vs. 2.9 control, P = 0.222	Intervention
Brandel et al. (2017)	USA	65	49.37 y	6.2% completed high school, 72.3 with some college or trade school, 21.5% with some graduate school	Breast reconstruction, breast reduction, and abdominoplasty	Standard patient education plus procedure-specific interactive Web-based educational module (details about type of interactive features not specified) versus standard patient education plus generic safety Web-based module (control)	Risks, benefits, alternatives, general knowledge about procedure	Surgically focused, modified version of the Shared Decision-making 25 index tool	Not specified	High risk of bias	“No differences between experimental groups” (no P value given)	Neither

^*Immediately: within 1 hour of informed consent consultation; early: >1 hour but <24 hours of informed consent consultation, delayed: ≥ 24 hours after informed consent consultation

^†Assessed using the Cochrane Risk of Bias 2.0 tool, see Table 7 for details

^‡If a study reported an improvement in patient comprehension on a single item or multiple items of the comprehension assessment but if overall score did not improve, we considered neither or no group to be favored