The 2018 Common Rule revision intended to improve informed consent by recommending a concise key information (KI) section, yet provided little guidance about how to describe KI. We developed innovative, visual KI templates with attention to health literacy and visual design principles. We explored end users’ attitudes, beliefs, and institutional policies that could affect implementing visual KI pages.

From October 2023 to April 2024, we conducted semi-structured interviews with principal investigators, research staff, and Institutional Review Board (IRB) personnel, including those in oversight/management, and community partners. Forty participants from three academic institutions (in the Midwest, Southeast, and Mountain West) viewed example KI pages and completed interviews. We coded written transcripts inductively and deductively based on the capability, opportunity, and motivation to change behavior (COM-B) framework. Data were analyzed using content analysis and organized thematically.

Participants responded positively to the visual KI examples. They discussed potential benefits, including improving information processing and understanding of study procedures, diversity in research, trust in research, and study workflow. They also described potential challenges to consider before widespread implementation: IRBs’ interpretations of federal guidelines, possible impacts on IRB submission processes, the effort/skill required to develop visuals, and difficulty succinctly communicating study risks. There was no consensus about when to use visual KI during consent, and some wondered if they were feasible for all study types.

Visual KI offers a promising solution to long-standing informed consent challenges. Future work can explore resources and training to address challenges and promote widespread use.

Clinical research trials rely on informed consent forms (ICFs) to explain all aspects of the study to potential participants. Despite efforts to ensure the readability of ICFs, concerns about their complexity and participant understanding persist. There is a noted gap between Institutional Review Board (IRB) standards and the actual readability levels of ICFs, which often exceed the recommended 8th-grade reading level. This study evaluates the readability of over five thousand ICFs from ClinicalTrials.gov in the USA to assess their literacy levels.

We analyzed 5,239 US-based ICFs from ClinicalTrials.gov using readability metrics such as the Flesch Reading Ease, Flesch-Kincaid Grade Level, Gunning Fog Index, and the percentage of difficult words. We examined trends in readability levels across studies initiated from 2005 to 2024.

Most ICFs exceeded the recommended 8th-grade reading level, with an average Flesch-Kincaid Grade Level of 10.99. While 91% of the ICFs were written above the 8th-grade level, there was an observable improvement in readability, with fewer studies exceeding a 10th-grade reading level in recent years.

The study reveals a discrepancy between the recommended readability levels and actual ICFs, highlighting a need for simplification. Despite a trend toward improvement in more recent years, ongoing efforts are necessary to ensure ICFs are comprehensible to participants of varied educational backgrounds, reinforcing the ethical integrity of the consent process.

Limited research is available on how motivations to adopt plant-based diets and nutrition literacy influence diet quality. This study assessed diet quality, diet motives and nutrition literacy in vegans, vegetarians and semi-vegetarians and investigated predictors of dietary quality.

Cross-sectional study, participants completed an online survey about diet-related motives and nutrition literacy. Dietary intake was assessed with the Diet History Questionnaire III, and diet quality was calculated with the Healthy Eating Index (HEI)-2015. A one-way ANCOVA was used to compare diet quality, nutrition literacy and diet motives among diets. Hierarchical regression analysis was performed to identify significant predictors of diet quality.

Online survey, participants were recruited through paid targeted social media (Facebook/Instagram) advertising.

Adults following a plant-based diet, including 117 (52·5 %) vegans, 51 (22·9 %) vegetarians and 55 (24·6 %) semi-vegetarians.

Vegans had higher HEI-2015 scores (80·8 (sd 6·5), P < 0·001) compared to vegetarians (75·1 (sd 9·1)) and semi-vegetarians (76·8 (sd 7·5)). Most participants (74 %) had good nutrition literacy scores. Total nutrition literacy did not differ between groups, but vegans had higher vegetarian nutrition literacy than vegetarians and semi-vegetarians (P < 0·001). Ecological welfare, health and sensory appeal were highly important to all participants. Motives accounted for 12·8 % of the variance in diet quality scores. HEI-2015 scores were positively associated with motives of health and natural content, but negatively associated with weight control motivation (all P < 0·05).

Individuals following plant-based dietary patterns have high diet quality and nutrition literacy. Messages valuing intrinsic over extrinsic factors may facilitate healthier dietary adherence in this population.

This study examined the effectiveness of an intervention program to enhance the self-confidence of kindergarten teachers who address radiation-related health concerns among parents following the Fukushima Daiichi Nuclear Power Plant accident in March 2011, wherein radiation anxiety among mothers with young children was high. Kindergarten teachers are expected to address the concerns of these parents

Participants from 2 private kindergartens in Fukushima City were assigned to either the intervention group (n = 10), which received an intervention program comprising lectures, group discussions, and presentations, or the control group (n = 16), which received only written materials used in the intervention program. Changes in the measured scores post-intervention were calculated, and the mean values were compared between both groups using the Student’s t-test.

The primary outcome was self-confidence, and the difference-in-differences approach was used to assess the effectiveness of the intervention program. The study found a more significant difference between pre- and post-intervention self-confidence in the intervention group compared to the control group (P < 0.01).

The intervention program effectively enhanced the self-confidence of kindergarten teachers in dealing with radiation-related health concerns of parents with young children.

Complications of parotidectomy can have a massive impact on patients’ quality of life. This study aimed to evaluate the readability and quality of online health information on parotidectomy.

The search terms ‘parotidectomy’, ‘parotid surgery’, ‘parotidectomy patient information’ and ‘parotid surgery patient information’ were parsed through three popular search engines.

The websites were analysed using readability scores of the Flesch Reading Ease test and the Gunning Fog Index. The DISCERN instrument was used to assess quality and reliability. The average Flesch Reading Ease score was 50.2 ± 9.0, indicating that the materials were fairly difficult to read, the Gunning Fog Index score showed that the patient health information was suitable for an individual above 12th grade level, and the DISCERN score indicated that the online patient health information had fair quality. The Kruskal–Wallis test showed a significant difference in Flesch Reading Ease and DISCERN tool scores according to website category (p < 0.05).

Current online patient health information on parotidectomy is too difficult for the public to understand, and it exceeds the reading levels recommended by Health Education England and the American Medical Association.

Informed consent forms (ICFs) and practices vary widely across institutions. This project expands on previous work at the University of Arkansas for Medical Sciences (UAMS) Center for Health Literacy to develop a plain language ICF template. Our interdisciplinary team of researchers, comprised of biomedical informaticists, health literacy experts, and stakeholders in the Institutional Review Board (IRB) process, has developed the ICF Navigator, a novel tool to facilitate the creation of plain language ICFs that comply with all relevant regulatory requirements.

Our team first developed requirements for the ICF Navigator tool. The tool was then implemented by a technical team of informaticists and software developers, in consultation with an informed consent legal expert. We developed and formalized a detailed knowledge map modeling regulatory requirements for ICFs, which drives workflows within the tool.

The ICF Navigator is a web-based tool that guides researchers through creating an ICF as they answer questions about their project. The navigator uses those responses to produce a clear and compliant ICF, displaying a real-time preview of the final form as content is added. Versioning and edits can be tracked to facilitate collaborative revisions by the research team and communication with the IRB. The navigator helps guide the creation of study-specific language, ensures compliance with regulatory requirements, and ensures that the resulting ICF is easy to read and understand.

The ICF Navigator is an innovative, customizable, open-source software tool that helps researchers produce custom readable and compliant ICFs for research studies involving human subjects.

Understanding the predictors of belief in covid-related conspiracy theories and willingness to get vaccinated against COVID-19 may aid the resolution of current and future pandemics.

We aim to investigate how psychological and cognitive characteristics influence general conspiracy mentality and covid-related conspiracy theories.

A cross-sectional study was conducted based on data from an online survey of a sample of Czech university students (n=866) collected in January 2021, using multivariate linear regression and mediation analysis.

Sixteen percent of respondents believed that COVID-19 is a hoax; 17% believed that COVID-19 was intentionally created by humans. Seven percent of the variance of the hoax theory and 10% of the variance of the creation theory was explained by (in descending order of relevance) low cognitive reflection, low digital health literacy, high experience with dissociation and, to some extent, high bullshit receptivity. Belief in covid-related conspiracy theories depended less on psychological and cognitive variables compared to conspiracy mentality (16% of the variance explained). The effect of digital health literacy on belief in covid-related theories was moderated by cognitive reflection.

Belief in conspiracy theories related to COVID-19 was influenced by experience with dissociation, cognitive reflection, digital health literacy and bullshit receptivity.

No significant relationships.

To explore mothers’ perceptions of malnutrition and its causes in U-5’s in Mozambique, as well as their ability to recognise, prevent and act on signs of malnutrition.

A qualitative exploratory inquiry using focus group discussions and individual interviews analysed using Nutbeam’s health literacy themes.

Manhiça District Hospital in Manhiça, Mozambique.

Mothers of U-5’s (n 53) attending the in- and out-patient paediatric wards.

Different malnutrition literacy levels were identified in mothers’ responses. Mothers’ reflections on the causes of malnutrition in U-5’s were more elaborate compared to those of recognition, prevention and treatment strategies. Only severe forms of acute malnutrition were recognised by mothers, while early signs of undernutrition and stunting largely went undetected or unmentioned. Limited knowledge, time and financial resources were mentioned as contributors to suboptimal practices resulting in malnutrition. The district hospital, rather than community resources or local health posts, was indicated as the place mothers would go to seek advice and treatment for malnutrition. All mothers requested additional information on how to prevent and treat malnutrition.

The varying literacy levels among mothers, the lack of references to community health workers as a resource in identifying and managing malnutrition, and the identification of poverty and sociocultural conditions as contributors to suboptimal practices indicate the need for in-depth research focused on the social determinants of malnutrition. A more comprehensive understanding of mothers’ health literacy would contribute to the development of holistic programmes aiming to improve community management of malnutrition.

Advance care planning is vital for ensuring individuals receive end-of-life care that is consistent with their care preferences and improves patient quality of life and satisfaction with care; however, only 11% of Americans have discussed advance care planning with a healthcare provider. Individuals with limited health literacy are even less likely to participate in advance care planning due to difficulty comprehending complex health information. The purpose of this review was to identify randomized controlled trials designed to address the effects of limited health literacy on advance care planning, evaluate the quality of these studies, and summarize evaluation data to inform future studies.

This systematic review examined randomized controlled trials published from January 1997 to July 2020 using the PubMed, CINAHL, PsycINFO, and Scopus databases. Data were extracted and two reviewers independently evaluated the quality of studies using the Joanna Briggs Institute Critical Appraisal Tool.

The database search yielded 253 studies and five studies were included in the final review. Studies were conducted in mostly White patients in outpatient clinics in the United States. Researchers wrote text at lower reading levels, added images to materials, and created videos to enhance communication. Health literacy interventions increased participant knowledge, preference for comfort care, engagement, and care documentation; however, several methodological issues were identified, including baseline differences in treatment and control groups, issues with blinding, lack of valid and reliable outcome measures, and inappropriate statistical analyses.

More high-quality intervention studies that address the effects of limited health literacy on advance care planning in diverse populations and settings are needed. Future intervention studies should use reliable and valid instruments to measure advance care planning outcomes. Clinicians should use materials appropriate for their patients’ health literacy levels to address their advance care planning needs.