Abstract
Objective:
Informed consent forms for research are often lengthy and complex. One way to improve consent forms is to clarify the key information page required for federally funded research in the United States. We developed a visual key information page using color, plain language, bulleted text, and icons. In formative studies, the visual key information page was positively received, but some asked whether icons improve outcomes or distract from information. This study tested whether icons affect knowledge, satisfaction, or engagement with study information.
Methods:
We recruited English-speaking, U.S.-based adults through Prime Panels. Participants were randomized to view one of three versions of a key information page about a hypothetical biobank study: Version A used bulleted, plain language text organized in boxes, incorporating icons and visual elements; Version B was identical but with no icons or other visual elements; Version C displayed identical plain language text only. We measured participants' intention to join the study, decisional conflict about choice intention, knowledge of study details, satisfaction with the information, and engagement with the information. Finally, they viewed all versions and reported their preference among the three and their attitudes about icons in Version A.
Key Results:
A total of 453 participants responded; we analyzed 422 valid responses. There were no significant differences in outcomes by version (all p values > .05), including when stratifying by health literacy. After viewing all versions, most (69.4%) preferred Version A over other versions. In addition, most liked the icons (78.2%), found them helpful (74.2%) and did not find them distracting (77%).
Conclusions:
Although participants preferred icons and visual elements over text alone, icons and visual elements did not affect knowledge, satisfaction, or engagement with study information. Future research will investigate whether and how visual key information enhances text-based consent forms in a multisite randomized trial with ongoing studies.
Plain language summary
Plain Language Summary: We tested whether including icons, color, and visual elements in information about a research study helped people understand or engage with the information. We learned that the icons and visuals did not impact these outcomes. However, people liked the version of the information with icons more than the versions without them.
Informed consent forms for research are often lengthy, complex, and do not always support informed decisions about study participation (Burks & Keim-Malpass, 2019; Cooksey et al., 2022; Mandava et al., 2012; Simonds et al., 2017). The “key information page,” which is required for U.S. federally funded research, has the potential to improve understanding of research studies. The intent is to provide “a concise and focused presentation of the key information that is most likely to assist a prospective subject…in understanding the reasons why one might or might not want to participate in the research” (Office for Human Research Protections, 2025). In some studies with minimal risks, the key information page might be the only required information needed for informed consent. In others, it gives the potential participant an overview of what to expect before they review the rest of the longer informed consent document.
Through a series of mixed-methods studies, we developed a visual key information page based on best practices in health literacy, using color, plain language, bulleted text, and adding icons (Cooksey et al., 2024; Hill et al., 2025; Kim & Kim, 2015). It includes sections in sequential boxes that correspond with informed consent best practices and federal guidelines, such as the study purpose, duration, main risks and benefits, the voluntary nature of participation, appropriate alternatives, costs, and compensation. In qualitative and quantitative pilot work, the visual key information page was positively received, but some people wondered whether icons specifically improve outcomes or potentially distract from information (Cooksey et al., 2024; Hill et al., 2025). In many health contexts, using pictures and graphics greatly facilitates understanding of health information, particularly for lower literate populations (Houts et al., 2006; Schubbe et al., 2020). However, some icons, when not carefully selected or tested for understanding, can be confusing or misleading to participants (Lujie et al., 2024; Prasetyo et al., 2021). For example, images of headaches could appear as someone thinking, images of a rash could appear as pain, or images of coughing could appear as vomiting (Dowse et al., 2023). During the corona virus disease 2019 (COVID-19) pandemic, icons were often used to communicate important recommended public health behaviors alongside text. Those that were concrete, familiar, and referred precisely to their intended meaning tend to be rated highly and understandable, while others were less effective. In the context of risk communication, icon arrays are often used to summarize and help users make sense of statistics, but images of people tend to be more salient to some users than images of blocks or ovals (Lujie et al., 2024; Prasetyo et al., 2021; Zikmund-Fisher et al., 2014). Standardizing the design is also recommended to facilitate comprehension.
Objective
We explored perceptions of the icons we chose for our visual key information pages in qualitative work (Cooksey et al., 2024) and standardized their design, recommending that they are placed alongside text for clear communication. Given icons' potential for misunderstanding when not carefully selected and tested, to inform our visual key information page for this larger body of work, this study tested whether icons affect knowledge, satisfaction, or engagement with study information when used for consent information alongside clear text.
Methods
We recruited adults age 18 years and older who speak English through CloudResearch Prime Panels, an opt-in survey platform for conducting online research. Before beginning study procedures, participants reviewed a brief page with consent information about the study. The study was approved as exempt research by the Washington University Institutional Review Board (202501029).
Study Design
Participants were first asked to imagine that their doctor invited them to participate in a biobank study (Figure A). They were randomized using 1:1:1 randomization to view one of three versions of a key information page for this hypothetical biobank study. The study details were based on a real ongoing study. Version A (only labelled for our purposes and not described with Version name for participants) displayed bulleted, plain language text in sequential boxes to organize information and incorporated icons and other visual elements (color, white space, and bolded headings). Version B displayed bulleted, plain language text in sequential boxes to organize information, but no icons or other visual elements. Version C displayed plain language text only. All text was worded identically across versions. Participants were then asked to complete a survey (see Figure B for all items).
Figure A.
Hypothetical Biobank Study
Figure B.
Survey Items
Intention to join the hypothetical study was assessed with a single item, “Based on the information you reviewed, do you think you would choose to participate in this study?” with response options yes, no, unsure. Decisional conflict about participation was measured with the validated four-item SURE measure adapted for this study (Légaré et al., 2010). Knowledge of specific study details in the consent display was measured with six items answered as true, false, unsure responses (O'Connor, 1999). Satisfaction with study information was based on items from the Health Information National Trends Survey (National Cancer Institute, n.d.). Engagement with the study information was assessed using five pairs of polar adjectives asking people to indicate how they felt about the information (Comello et al., 2016).
After completing the survey, they were shown all three key information versions and asked for their preference among the three and their attitudes about the icons shown in the version that included them. Device type (desktop or mobile) and health literacy as measured by the Single Item Literacy Screener were also collected (Morris et al., 2006). Participants were compensated per the terms of service of the survey platform through which they were recruited.
Data Analysis
We hypothesized that there would not be differences in knowledge across randomized groups, but that individuals would be more satisfied and engaged with study-related information in the icon/visual group compared to text alone. We aimed to explore whether results of this comparison varied by health literacy or device type used (computer or mobile device). Intention to join the study was calculated as the percentage indicating yes, no, or unsure. The SURE measure of decisional conflict was dichotomized into the presence of decisional conflict (scores <3) or absence of decisional conflict. Knowledge was scored with the percentage answering correctly out of the total possible items; incorrect, unsure, and missing responses were coded as incorrect. Satisfaction with information and engagement with study information were scored on a Likert scale, where higher scores indicated more satisfaction or more engagement, respectively. Demographic information was reported using frequencies and percentages by category. We included an attention check question in the middle of the survey and planned a priori to exclude participants who did not answer correctly. We also planned a priori to exclude participants who completed the survey in <120 seconds, indicating potential lack of attention to stimuli or survey questions, because the average duration in our initial testing was 289 seconds, and the median was 214 seconds. We used linear regression or chi-square analysis to examine the impact of key information page version on knowledge, satisfaction, and engagement with study materials. We used chi-square analysis to examine the impact of key information page version on intention to join the study and decisional conflict about choice intention. We added an interaction term to the regression model for continuous outcomes and used the Cochran-Mantel-Haenszel test for categorical outcomes when exploring whether results varied by health literacy or device type.
Results
A total of 453 participants responded to the survey link; we analyzed 422 valid responses. We excluded 3 participants for failing to answer the attention check question correctly, 15 participants who completed the survey in <120 seconds, 10 participants who answered in a straight-line pattern (e.g., all of the same multiple choice option was checked, such as answer choice C) for all 3 of the survey sections, and 2 participants who met more than 1 of these criteria. One record was excluded due to a technical failure recording the assigned condition. Thirty-one records (6.8%) were ultimately excluded. The average age of participants was 51.1 years (range = 18–84; SD = 17.4). Table 1 displays additional demographic characteristics of included participants.
Table 1.
Participant Demographics by Version Viewed
| Characteristic | Viewed A (n = 135) | Viewed B (n = 145) | Viewed C (n = 142) | Total (n = 422) |
|---|---|---|---|---|
|
| ||||
| n (%) | ||||
|
| ||||
| Sex | ||||
| Female | 55 (40.7) | 67 (46.2) | 61 (43.0) | 183 (43.4) |
| Male | 80 (59.3) | 75 (51.7) | 79 (55.6) | 234 (55.5) |
| Another response or missing data | 0 (0.0) | 3 (2.1) | 2 (1.4) | 5 (1.2) |
|
| ||||
| Race and ethnicity | ||||
| White | 89 (65.9) | 85 (58.6) | 102 (71.8) | 276 (65.4) |
| Black or African American | 29 (21.5) | 29 (20.0) | 19 (13.4) | 77 (18.2) |
| Asian or Asian American | 2 (1.5) | 10 (6.9) | 2 (1.4) | 14 (3.3) |
| Hispanic or Latino/a/e (White) | 1 (0.7) | 5 (3.4) | 3 (2.1) | 9 (2.1) |
| Hispanic or Latino/a/e | 8 (5.9) | 8 (5.5) | 5 (3.5) | 21 (5.0) |
| Native American or Alaska Native | 1 (0.7) | 1 (0.7) | 0 (0.0) | 2 (0.5) |
| Middle Eastern or North African | 0 (0.0) | 1 (0.7) | 0 (0.0) | 1 (0.2) |
| Multiracial or self-described | 5 (3.7) | 6 (4.1) | 10 (7.0) | 21 (5.0) |
| Prefer not to say | 0 (0.0) | 0 (0.0) | 1 (0.7) | 1 (0.2) |
|
| ||||
| Education | ||||
| Less than a college degree | 81 (60.0) | 66 (45.5) | 70 (50.3) | 217 (51.4) |
| College degree or more | 54 (40.0) | 79 (54.5) | 71 (49.0) | 204 (48.3) |
| Missing data/prefer not to say | 0 (0.0) | 0 (0.0) | 1 (0.7) | 1 (0.2) |
|
| ||||
| Finances | ||||
| There's not enough to make ends meet | 32 (23.7) | 30 (20.7) | 22 (15.5) | 84 (19.9) |
| There's enough to make ends meet, but not enough for “extras” | 64 (47.4) | 71 (49.0) | 79 (55.6) | 214 (50.7) |
| There's plenty left over | 36 (26.7) | 41 (28.3) | 36 (25.4) | 113 (26.8) |
| Prefer not to answer | 3 (2.2) | 3 (2.1) | 5 (3.5) | 11 (2.6) |
|
| ||||
| Single Item Literacy Screener | ||||
| Limited | 23 (17.0) | 23 (15.9) | 20 (14.1) | 66 (15.6) |
| Adequate | 112 (83.0) | 121 (83.4) | 122 (85.9) | 355 (84.1) |
| Missing | 0 (0.0) | 1 (07) | 0 (0.0) | 1 (0.2) |
|
| ||||
| Device used | ||||
| Mobile/tablet | 89 (65.9) | 93 (64.1) | 80 (56.3) | 262 (62.1) |
| Desktop | 45 (33.3) | 51 (35.2) | 62 (43.7) | 158 (37.4) |
| Unknown | 1 (0.7) | 1 (0.7) | 0 (0.0) | 2 (0.5) |
There were no statistically significant differences by randomized version in knowledge, satisfaction, or engagement with study materials (Table 2). There were also no significant differences in intention to participate by randomized version or in decisional conflict about participation (Table 3) (p > .05). Participants who selected not sure about joining the study stated that they would want to know more about study safeguards to prevent a breach of confidentiality, and/or that they would want to know how their clinician felt about the study.
Table 2.
Knowledge, Satisfaction, and Engagement with Study Materials by Key Information Page Version
| Outcome | Version A (Boxes + Icons) n = 135 | Version B (Boxes, No Icons) n = 145 | Version C (Text Only) n = 142 | ||
|---|---|---|---|---|---|
| Knowledge | |||||
| Mean 6-item knowledge score | 71.7% (SD = 25.6) (p(A vs. C) = 0.7) | 70.5% (SD = 25.3) (p(B vs. C) > 0.9) | 70.4% (SD = 25.1) (Reference) | - | |
| n (%) | p a | ||||
| In this biobank study, we will study the differences between people's DNA that could explain how genes change disease riskb | |||||
| True (correct) | 114 (84.4) | 121 (83.4) | 113 (79.6) | .80 | |
| False | 3 (2.2) | 4 (2.8) | 6 (4.2) | ||
| Unsure | 18 (13.3) | 20 (13.8) | 23 (16.2) | ||
| I would need to attend extra appointments to join the studyb | |||||
| True | 32 (23.7) | 39 (26.9) | 39 (27.5) | .96 | |
| False (correct) | 73 (54.1) | 74 (51.0) | 73 (51.4) | ||
| Unsure or missing data | 30 (22.2) | 32 (22.1) | 30 (21.1) | ||
| If I joined the study, information about me might be collected from my medical recordb | |||||
| True (correct) | 97 (71.9) | 106 (73.1) | 96 (67.6) | .45 | |
| False | 21 (15.6) | 25 (17.2) | 33 (23.2) | ||
| Unsure or missing data | 17 (12.6) | 14 (9.7) | 13 (9.2) | ||
| I would have the option to get results from the study about health risks that researchers might discover in my DNAb | |||||
| True (correct) | 109 (80.7) | 116 (80.0) | 114 (80.3) | .81 | |
| False | 11 (8.1) | 14 (9.7) | 9 (6.3) | ||
| Unsure or missing data | 15 (11.1) | 15 (10.3) | 19 (13.4) | ||
| My care would be different if I decided to joinb | |||||
| True | 33 (24.4) | 30 (20.7) | 26 (18.3) | .74 | |
| False (correct) | 80 (59.3) | 86 (59.3) | 89 (62.7) | ||
| Unsure or missing data | 22 (16.3) | 29 (20.0) | 27 (19.0) | ||
| I would be able to withdraw my permission to use my samples at any timeb | |||||
| True (correct) | 108 (80.0) | 110 (75.9) | 115 (81.0) | .34 | |
| False | 11 (8.1) | 7 (4.8) | 8 (5.6) | ||
| Unsure or missing data | 16 (11.9) | 28 (19.3) | 19 (13.4) | ||
| Version A (Boxes + Icons) n = 135 | Version B (Boxes, No Icons) n = 145 | Version C (Text Only) n = 142 | |||
| Satisfaction with study information | |||||
| Mean 5-item satisfaction score (range = 1.00–5.00) | 3.57 (SD = 0.85) (p(A vs. C) = 0.6) | 3.58 (SD = 0.89) (p(B vs. C) = 0.5) | 3.52 (SD = 0.79) (Reference) | - | |
| Engagement with study information | |||||
| Mean 5-item engagement score (n = 404) (range = 1.00–5.00) | 3.67 (n = 128; SD = 0.99) (p(A vs. C) = 0.20) | 3.68 (n = 140; SD = 1.01) (p(B vs. C) = 0.20) | 3.52 (n = 136; SD = 0.94) (Reference) | - | |
Results for continuous outcomes analyzed using linear regression model. Proportions of true/false/unsure item responses compared using chi-square test.
n, % within condition.
Table 3.
Intention to Join and Decisional Conflict About Choice Intention by Randomized Version (N = 422)
| Decision Outcomes | Version A (Boxes + Icons) n = 135 | Version B (Boxes, No Icons) n = 145 | Version C (Text Only) n = 142 | Total | p a |
|---|---|---|---|---|---|
| n (%) | |||||
| Intend to join | 73 (54.1) | 95 (65.5) | 83 (58.5) | 251 (59.5) | .23 |
| Do not intend to join | 27 (20.0) | 28 (19.3) | 30 (21.1) | 85 (20.1) | |
| Not sure or missing data | 35 (25.9) | 22 (15.2) | 29 (20.4) | 86 (20.3) | |
| SURE decisional conflict (Légaré et al., 2010) | |||||
| No conflict | 81 (60.4) | 87 (60.4) | 85 (59.9) | 253 (60.2) | .99 |
| Conflict | 53 (39.6) | 57 (39.6) | 57 (40.1) | 167 (39.8) | |
Chi-square test.
We conducted stratified analyses of results by health literacy and by device type. There were no statistically significant interactions between health literacy, key information version, and outcome or between device type, key information version, and outcome (Table A). However, respondents in the limited health literacy category had lower knowledge scores (p = .014; independent samples t-test) and lower satisfaction scores (p < .001; independent samples t-test) than respondents in the adequate health literacy category, regardless of version viewed.
Table A.
Stratified Analyses of Results by Health Literacy and by Device Type
| Multivariable linear regression for knowledge score | |||||||
|---|---|---|---|---|---|---|---|
|
| |||||||
| Beta | 95% CI | p-value | Beta | 95% CI | p-value | ||
|
| |||||||
| Condition | 0.850 | Condition | 0.661 | ||||
| A | A | ||||||
| B | −0.02 | −0.08, 0.05 | B | 0.03 | −0.05, 0.10 | ||
| C | −0.01 | −0.08, 0.05 | C | −0.01 | −0.08, 0.07 | ||
|
| |||||||
| Health Literacy | 0.132 | Device type | 0.009 | ||||
| Adequate | Mobile | ||||||
| Limited | −0.09 | −0.20, 0.03 | Desktop | 0.12 | 0.03, 0.21 | ||
|
| |||||||
| Condition * Health Literacy | 0.786 | Condition * device type | 0.275 | ||||
| B * Limited | 0.03 | −0.13, 0.19 | B * Desktop | −0.10 | −0.22, 0.02 | ||
| C * Limited | −0.02 | −0.19, 0.14 | C * Desktop | −0.04 | −0.17, 0.08 | ||
Once participants viewed all three of the versions after completing the above survey questions, they indicated that they mostly liked the icons (330/422; 78.2% agreed or completely agreed) and found them helpful (313/422; 74.1%; agreed or completely agreed). Few (96/422; 22.7%) found the icons distracting.
When asked to indicate their preference for the version displayed, most (293; 69.4%) preferred Version A with boxes and bulleted text and the icons and visual elements. Only 64 (15.2%) preferred Version B with the boxes and bulleted text without icons or visual elements, and 62 (14.7%) preferred Version C with the text only. Participants were asked to share why they preferred one version; sample comments are presented in Table 4. Older participants were less likely to prefer version A or B (multinomial linear regression using C as reference group; OR = 0.98, p = .036). There was no statistically significant relationship between stated preference and other independent variables, including version viewed first, health literacy, device type, and other collected demographics (p > .05).
Table 4.
Sample Participant Comments About Preferred Version
| Preferred Version A (Icons + Boxes) (N = 293; 69.4%) | Preferred Version B (Boxes, No Icons) (N = 64; 15.2%) | Preferred Version C (Text Only) (N = 62; 14.7%) |
|---|---|---|
| “I thought it was the most professional. The graphics popped and really caught my eye. I think people would [be] more likely to look at this one in the first place.” | “It is well organized. The sheet does not have a lot of distractions and makes you focus on the questions and answers.” | “I prefer the simple, narrative question/answer version to the chart-style. It just flows better and it's more understandable to me.” |
| “The use of darker headline boxes organizes the page better and makes each heading stand out more. It's more attractive to look at. C is awful, no one these days with short-attention smartphone brain would make it to the bottom!” | “B just seems to be easier to understand and not so daunting to review all the pieces. C is too boring and overpowering, especially for folks who don't read English well. A is too frilly, with unnecessary graphics detracting from the details.” | “The other two were slightly more visually appealing, but distracting. C is straight to the matter without lines and arrows to contend with.” |
| “It looks like someone took effort to design it and that makes me feel more confident in the study itself” | “The heading for each set was easier to see than A, and the sets were more easily read than C.” | “I don't need fancy graphics. I like to read everything in paragraph formatting all in one area.” |
| “I like the symbols attached to each square explaining what is being [done].” | “All information without distracting pictures.” | “It seems more formal and expresses the gravity of the study.” |
Discussion
In this randomized trial comparing three different versions of key information (plain language in organized boxes with visual elements and icons, plain language in organized boxes without visual elements or icons, and plain language in text only) about a hypothetical biobank study, using icons and visual elements did not significantly impact knowledge, satisfaction with information, engagement with the information, intention to join a study, or decisional conflict about choice intention. However, when asked to view all three and rate their preference, most participants indicated that they liked the visual elements and icon version of key information better than the other versions. In qualitative comments, many commented that the version with visual elements and icons was attractive, professional, and they would trust or feel confident in the information if displayed in that format.
Although our study did not find a statistically significant difference in knowledge, satisfaction, choice intentions, or conflict about that choice intention, it is possible that results would differ in a situation where someone is upset or distressed, as can happen when patients are making decisions about clinical treatment trials. Future work could explore the impact of information displays in active clinical trials enrolling patients.
Our findings did not suggest any variation in results by health literacy, but they did show that those with limited health literacy had lower knowledge overall regardless of key information version viewed. More work is needed to improve knowledge about study-related information for those who can benefit most. Evidence-based assessment tools such as the Patient Education Materials Assessment Tool could be used to measure and improve the understandability and actionability of key information for informed consent (Shoemaker et al., 2014).
Although most individuals preferred the version of information with icons, visual elements, and plain language text, a minority of participants felt that the version with boxes alone was sufficient and commented that the visual elements could be distracting. Similarly, those who indicated that they preferred text only found it to be the simplest and most familiar or formal. We did find in our study that most people preferring the text only version were older in age than those preferring other versions; future work could explore whether there are additional characteristics that could impact preference for key information displays.
Study Limitations
The study was conducted using a hypothetical bio-bank scenario. It is possible that people would respond differently to studies they were considering joining, or other types of studies (e.g. clinical treatment studies, or minimal risk survey studies). Studies with more elaborate procedures or statistical designs such as stepped wedge randomized trials or longitudinal studies with many required visits over time might also yield different results. Although we recruited a large and reasonably diverse sample, we do not know how representative the sample is compared to those who could have joined. The survey platform does not track the denominator of those who might have viewed but not joined the study. We used a single-item literacy screener to assess health literacy; while this is a commonly used screener because it correlates with more objective measures and can be self-administered in a survey, there are other researcher-administered measures that could validate health literacy in future work. Mobile users saw questions about engagement displayed vertically, whereas desktop users saw them horizontally; this could have impacted responses. In addition, the survey was cross-sectional, and we do not know whether people stay engaged over time or retained information better when viewing information using visual elements and icons. Future work could employ a longitudinal study design to test this information. We standardized the placement of the icons and visual elements in the boxes, but icons in the headings or integrated throughout the text could yield different results. Future work could conduct cognitive interviewing to understand how users perceived the different displays of information or icons prior to comparing the display information in a randomized trial. Future work could also examine how the layout, format (bullets versus not), white space, number of words on the page, and other display information affects learning and encoding of information.
Conclusion
Overall, studies looking to incorporate best practices for designing key information pages of informed consent could benefit from health literacy principles, with or without icons and visual elements. However, since most expressed a preference for visual elements and icons in this study, incorporating simple, user-tested icons could enhance participant engagement in informed consent. Future work could examine the impact of key information pages with health literacy principles, icons and visual elements in ongoing studies with participants considering joining them; work is underway to examine this research question in a randomized trial across institutions and regions (ClinicalTrials.gov [NCT06804837]).
Funding Statement
Funding: This work was supported by the Alvin J. Siteman Cancer Center (NIH Cancer Center Support Grant P30 CA091842) and the Pilot Translational Clinical Studies Program of the Washington University Institute of Clinical and Translational Sciences (UL1TR002345). Siteman Cancer Center receives funding from the National Cancer Institute (T32CA009621).
References
- Burks , A. C. , & Keim-Malpass , J. ( 2019. ). Health literacy and informed consent for clinical trials: A systematic review and implications for nurses . Nursing: Research and Reviews , 9 , 31 – 40 . 10.2147/NRR.S207497 [DOI] [Google Scholar]
- Comello , M. L. G. , Qian , X. , Deal , A. M. , Ribisl , K. M. , Linnan , L. A. , & Tate , D. F. ( 2016. ). Impact of game-inspired infographics on user engagement and information processing in an eHealth program . Journal of Medical Internet Research , 18 ( 9 ), e237 . 10.2196/jmir.5976 PMID: [DOI] [PMC free article] [PubMed] [Google Scholar]
- Cooksey , K. E. , Goldstein , E. , Lee , C. , Mozersky , J. , Kaphingst , K. A. , Gallegos , V. C. , & Politi , M. C. ( 2024. ). Qualitative assessment of proposed visual key information pages for informed consent . Journal of Clinical and Translational Science , 8 ( 1 ), e218 . 10.1017/cts.2024.662 PMID: [DOI] [PMC free article] [PubMed] [Google Scholar]
- Cooksey , K. E. , Mozersky , J. , DuBois , J. , Kuroki , L. , Marx , C. M. , & Politi , M. C. ( 2022. ). Challenges and possible solutions to adapting to virtual recruitment: Lessons learned from a survey study during the COVID-19 pandemic . Ethics & Human Research , 44 ( 6 ), 23 – 31 . 10.1002/eahr.500148 PMID: [DOI] [PMC free article] [PubMed] [Google Scholar]
- Dowse , R. , Okeyo , S. , Sikhondze , S. , & Khumalo , N. ( 2023. ). Pharmaceutical indication pictograms for low literacy viewers: Health literacy and comprehension . Health SA = SA Gesondheid , 28 , 2192 . 10.4102/hsag.v28i0.2192 PMID: [DOI] [PMC free article] [PubMed] [Google Scholar]
- Hill , A. , Housten , A. J. , Cooksey , K. , Goldstein , E. , Mozersky , J. , & Politi , M. C. ( 2025. ). Accelerating implementation of visual key information to improve informed consent in research: A single-institution feasibility study and implementation testing . BMJ Open , 15 ( 3 ), e092185 . 10.1136/bmjopen-2024-092185 PMID: [DOI] [PMC free article] [PubMed] [Google Scholar]
- Houts , P. S. , Doak , C. C. , Doak , L. G. , & Loscalzo , M. J. ( 2006. ). The role of pictures in improving health communication: A review of research on attention, comprehension, recall, and adherence . Patient Education and Counseling , 61 ( 2 ), 173 – 190 . 10.1016/j.pec.2005.05.004 PMID: [DOI] [PubMed] [Google Scholar]
- Kim , E. J. , & Kim , S. H. ( 2015. ). Simplification improves understanding of informed consent information in clinical trials regardless of health literacy level . Clinical Trials: Journal of the Society for Clinical Trials , 12 ( 3 ), 232 – 236 . 10.1177/1740774515571139 PMID: [DOI] [PubMed] [Google Scholar]
- Légaré , F. , Kearing , S. , Clay , K. , Gagnon , S. , D'Amours , D. , Rousseau , M. , & O'Connor , A. ( 2010. ). Are you SURE?: Assessing patient decisional conflict with a 4-item screening test . Canadian Family Physician Médecin de Famille Canadien , 56 ( 8 ), e308 – e314 PMID: [PMC free article] [PubMed] [Google Scholar]
- Lujie , D. , Lin , C. , Liao , Q. , & Qiu , S. ( 2024. ). The effects of icon design features on user perception and preference: A case study of icons for Covid-19 . PLoS One , 19 ( 9 ), e0305290 . 10.1371/journal.pone.0305290 PMID: [DOI] [PMC free article] [PubMed] [Google Scholar]
- Mandava , A. , Pace , C. , Campbell , B. , Emanuel , E. , & Grady , C. ( 2012. ). The quality of informed consent: Mapping the landscape. A review of empirical data from developing and developed countries . Journal of Medical Ethics , 38 ( 6 ), 356 – 365 . 10.1136/medethics-2011-100178 PMID: [DOI] [PMC free article] [PubMed] [Google Scholar]
- Morris , N. S. , MacLean , C. D. , Chew , L. D. , & Littenberg , B. ( 2006. ). The Single Item Literacy Screener: Evaluation of a brief instrument to identify limited reading ability . BMC Family Practice , 7 , 21 . 10.1186/1471-2296-7-21 PMID: [DOI] [PMC free article] [PubMed] [Google Scholar]
- National Cancer Institute . ( n.d.. ). Health information national trends survey: All HINTS questions . https://hints.cancer.gov/view-questions/all-hints-questions.aspx [Google Scholar]
- O'Connor , A . ( 1999. ). Sample tool: Knowledge (tamoxifen) . http://decisionaid.ohri.ca/docs/develop/Tools/Knowledge_Tamoxifen.pdf
- Office for Human Research Protections . ( 2025. , February ). Draft guidance– Key Information and Facilitating Understanding in Informed Consent . U.S. Department of Health and Human Services; . https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-key-information-facilitating-understanding-informed-consent/index.html [Google Scholar]
- Prasetyo , Y. T. , Dewi , R. S. , Balatbat , N. M. , Antonio , M. L. B. , Chuenyindee , T. , Perwira Redi , A. A. N. , Young , M. N. , Diaz , J. F. T. , & Kurata , Y. B. ( 2021. ). The evaluation of preference and perceived quality of health communication icons associated with COVID-19 prevention measures . Healthcare (Basel) , 9 ( 9 ), 1115 . 10.3390/healthcare9091115 PMID: [DOI] [PMC free article] [PubMed] [Google Scholar]
- Schubbe , D. , Scalia , P. , Yen , R. W. , Saunders , C. H. , Cohen , S. , Elwyn , G. , van den Muijsenbergh , M. , & Durand , M. A. ( 2020. ). Using pictures to convey health information: A systematic review and meta-analysis of the effects on patient and consumer health behaviors and outcomes . Patient Education and Counseling , 103 ( 10 ), 1935 – 1960 . 10.1016/j.pec.2020.04.010 PMID: [DOI] [PubMed] [Google Scholar]
- Shoemaker , S. J. , Wolf , M. S. , & Brach , C. ( 2014. ). Development of the Patient Education Materials Assessment Tool (PEMAT): A new measure of understandability and actionability for print and audiovisual patient information . Patient Education and Counseling , 96 ( 3 ), 395 – 403 . 10.1016/j.pec.2014.05.027 PMID: [DOI] [PMC free article] [PubMed] [Google Scholar]
- Simonds , V. W. , Garroutte , E. M. , & Buchwald , D. ( 2017. ). Health literacy and informed consent materials: Designed for documentation, not comprehension of health research . Journal of Health Communication , 22 ( 8 ), 682 – 691 . 10.1080/10810730.2017.1341565 PMID: [DOI] [PMC free article] [PubMed] [Google Scholar]
- Zikmund-Fisher , B. J. , Witteman , H. O. , Dickson , M. , Fuhrel-Forbis , A. , Kahn , V. C. , Exe , N. L. , Valerio , M. , Holtzman , L. G. , Scherer , L. D. , & Fagerlin , A. ( 2014. ). Blocks, ovals, or people? Icon type affects risk perceptions and recall of pictographs . Medical Decision Making: An International Journal of the Society for Medical Decision Making , 34 ( 4 ), 443 – 453 . 10.1177/0272989X13511706 PMID: [DOI] [PMC free article] [PubMed] [Google Scholar]