Recommendations for developing accessible patient information leaflets for clinical trials to address English language literacy as a barrier to research participation.

BACKGROUND: Low English language literacy is a common barrier to participation in clinical trials. Patient information leaflets (PILs) used in clinical trials are often lengthy, complex and have poor readability; this is a persistent and prevalent problem common to trials across the world. Simplifying the information provided in PILs can lead to improved understanding, comprehension and knowledge. The aim of this project was to develop recommendations for developing accessible PILs for clinical trials through a literature review of published and grey literature and co-working with marginalised communities, patients, and health and social care charities. METHODS: A literature review of MEDLINE, Embase and online resources was conducted, and recommendations for developing accessible PILs were extracted from eligible published and grey literature. Grey literature which contained insights into more inclusive forms of communication was also identified and summarised. Meetings were held with two racially marginalised community groups, two groups involving autistic adults and/or adults with learning difficulties and a patient advisory group. Examples of accessible PILs were shared and discussions held about the content and format of the PILs and suggestions for changes/improvements. National Voices, a coalition of health and social care charities in England, held a national online workshop with charities and lived experience partners. Recommendations identified from the multiple sources were coded, collated and refined to develop an overarching framework of recommendations. RESULTS: The framework consists of 74 recommendations for developing accessible PILs for clinical trials. Recommendations cover the five topics of formatting, information presentation, writing style, content and accessibility. CONCLUSIONS: This project has developed a comprehensive framework of recommendations to guide researchers in the development of accessible PILs for clinical trials. Findings from previous research and from co-working with marginalised communities, patients and health and social care charities were collated to ensure that a diverse range of voices and experiences informed the framework. These recommendations aim to support researchers to develop better study information to reduce English language literacy as a barrier to participation in clinical trials.

Exploring the ability of ChatGPT to create quality patient education resources about kidney transplant.

BACKGROUND: Chat Generative Pre-trained Transformer (ChatGPT) is a language model that may have the potential to revolutionize health care. The study purpose was to test whether ChatGPT could be used to create educational brochures about kidney transplant tailored for three target audiences: caregivers, teens and children. METHODS: Using a list of 25 educational topics, standardized prompts were employed to ensure content consistency in ChatGPT generation. An expert panel assessed the accuracy of the content by rating agreement on a Likert scale (1 = <25 % agreement; and 5 = 100 % agreement). The understandability, actionability and readability of the brochures were assessed using the Patient Education Materials Assessment Tool for printable materials (PEMAT-P) and standard readability scales. A caregiver and patient reviewed and provided written feedback. RESULTS: We found mean understandability scores of 69 %, 66 %, and 73 % for caregiver, teen, and child brochures respectively, with 90.7 % of the ChatGPT generated brochures scoring 40 % on the actionability scale. Generated caregiver and teen materials achieved readability levels of grades 9-14, while child-specific brochures achieved readability levels of grades 6-11. Brochures were formatted appropriately but lacked depth. CONCLUSION: ChatGPT demonstrates potential for rapidly generating patient education materials; however, challenges remain in ensuring content specificity. We share the lessons learned to assist other healthcare providers with using this technology.

Recognition and comprehension of breast awareness among hospital staff: a questionnaire survey using the explanatory leaflet in Japan.

BACKGROUND: This study aimed to assess the recognition and understanding of breast awareness (BA) among hospital staff, a group considered influential in disseminating information about health. Compared to the traditional approach of breast self-examination (BSE), BA has gained prominence as a concept focused on early detection. The study also explored the effectiveness of an informational leaflet in conveying BA concepts. METHODS: We conducted an online, voluntary, and anonymous questionnaire survey at St. Luke's International Hospital in Japan, where approximately 1,000 breast cancer surgeries are performed annually. The survey comprised three sections: pre-leaflet questions, the informational leaflet, and post-leaflet questions. RESULTS: From a pool of 500 completed questionnaires, 499 were deemed suitable for the analysis. Notably, 78% of respondents were unfamiliar with "BA" before the survey. However, 89.1% expressed interest in adopting daily practices for early breast cancer detection. Following the leaflet exposure, 98.4% of respondents claimed to have understood BA, either completely or partially. The leaflet aided 93.2% of these individuals in differentiating between BA and the traditional BSE method. These outcomes remained consistent across various demographic segments such as occupation, age, and experience with breast cancer care. CONCLUSIONS: The study underscores a concerning lack of awareness regarding BA among hospital staff within the surveyed institution. This highlights the need to engage medical professionals in promoting BA within the community. The informational leaflet proved effective in enhancing comprehension of BA across diverse groups, indicating its potential as a widely applicable educational tool. The leaflet facilitated the comprehension of BA among respondents across all demographic groups, indicating its potential for widespread utility.

A web-based and mobile randomised controlled trial providing complementary feeding guidelines to first-time parents in France to promote responsive parental feeding practices, healthy children's eating behaviour and optimal body mass index: the NutrienT trial study protocol.

BACKGROUND: Childhood obesity is a crucial public health issue. Early childhood is a critical time to foster the establishment of healthy eating behaviours and growth, which are partly shaped by parental feeding practices. To inform French parents of the recently updated national complementary feeding guidelines for 0-3 years (in terms of nutrition and responsive feeding as a mean to encourage infant appetite control skills and promote healthy growth), an official printed brochure was developed and nationally disseminated in 2021 by the French public health agency, Santé publique France. This randomised controlled trial aims to investigate whether the provision of guidelines through digital (smartphone application) and printed (brochure) tools (vs. the printed brochure alone, usual service) results in healthier parental feeding practices, infant eating behaviours and weight status. METHODS: This double-blinded monocentric 2-arm trial is currently conducted among first-time parents living in the area of Dijon (France) and recruited in a maternity ward. From child age 3 to 36 months (mo), an app provides a range of 106 age-adapted messages, including dietary recommendations, educational advice, recipes, and tips (intervention group only). Additionally, parents of both groups are provided with 48 messages related to child general development and the printed brochure at child age 2.7 mo. The primary outcome is the body mass index (BMI) z-score at child age 36 mo. Secondary outcome measures include a combination of online parents' reports and behavioural assessments (experimental meals) of parental feeding practices and infant eating behaviours from inclusion to 36 months of age. Analyses of covariance on these outcomes will assess the effect of the intervention, adjusted for relevant confounders. Complementary mediation and moderation analyses will be conducted. Sample size was determined to be n = 118 in each arm of the trial, plus 20% to compensate for potential attrition. DISCUSSION: This is the first public eHealth randomised control trial in France to assess the effect of a web-based and mobile intervention targeted to first-time parents to improve child feeding practices and child growth. TRIAL REGISTRATION: This trial was registered at clinicaltrials.gov as NCT05285761 (March 18, 2022).

Reliability, usability, and efficiency of video versus print instructions to teach parents a procedural task: A cross-sectional study.

OBJECTIVE: To compare the reliability, usability, and efficiency of video versus print instructions to teach parents a procedural measurement task. We hypothesized that videos would outperform print in all outcomes. STUDY DESIGN: This cross-sectional study included parents/caregivers of children aged 0-18 years with deep vein thrombosis attending the Thrombosis Clinic at The Hospital for Sick Children for post-thrombotic syndrome (PTS) assessment. Participants were randomly assigned to three instruction types: (i) video, which followed the technique used by clinicians; (ii) long pamphlet, which also followed the clinicians' technique; and (iii) short pamphlet, which explained a simplified technique. After measuring their children's arms or legs using the randomly assigned material, participants completed a usability questionnaire. The reliability of the instructions was estimated by comparing parents/caregivers versus clinicians' measurements using the intraclass correlation coefficient (ICC). Reliability, usability, and efficiency (time to task completion) were compared among the three instruction types. RESULTS: In total, 92 participants were randomized to video (n = 31), long pamphlet (n = 31), and short pamphlet (n = 30). While the video had the highest usability, the short pamphlet was the most reliable and efficient. ICCs were .17 (95% confidence interval [CI]: .00-.39) for the video, .53 (95% CI: .30-.72) for the long pamphlet, and .70 (95% CI: .50-.81) for the short pamphlet. CONCLUSION: Although the video had higher usability, the short/simplified print instruction was more reliable and efficient. However, the reliability of the short pamphlet was only moderate/good, suggesting that whenever possible, measurements should still be obtained by trained clinicians.

Punxsutawney, Pennsylvania Pamphlet Proselytizing Preventive Dentistry, by Drs. Morrison and Henry.

Advice on preventive dental care for children, prior to 1900 is scarce. In the 1890s, Drs. Morrison and Henry, two Punxsutawny, Pennsylvania dentists, cogently offered such advice in their promotional pamphlet, along with some lessons on life, as reflected by precious stones.

Integrating AI-Generated Summaries of Medication Leaflets into a Mobile Application for Medication Management.

Effective medication management poses significant challenges, particularly when navigating multiple medications with intricate dosages and schedules. This paper presents a prototype mobile application to streamline information retrieval from dense medication leaflets. By utilizing automated information extraction based on large language models, the application seamlessly retrieves pertinent details from the Austrian medicinal product index upon scanning the medication package. This extracted information is organized and displayed within the app, ensuring clarity and accessibility for users. In addition to this core functionality, the application offers a suite of features tailored to facilitate effective medication management. By integrating comprehensive medication information with practical medication management tools, the application empowers users to navigate complex medication regimes with confidence and ease.

The effect of brochure-assisted education given before septorhinoplasty on surgical fear and anxiety: A randomized controlled trial.

This study is a randomized controlled interventional study aimed to determine the effect of preoperative brochure-assisted education on surgical fear and anxiety in patients scheduled for septorhinoplasty surgery. The study was conducted between May 2022 and February 2023 in the Otorhinolaryngology services and clinics of a training and research hospital in the southern region of Turkey. The study included 61 patients, with 29 in the education group and 32 in the control group. All patients received routine nursing care before surgery, with the education group receiving additional education through an informative brochure. The data were collected using the "Personal Information Form", "Surgical Fear Questionnaire", and "Surgical Anxiety Questionnaire". There was no significant difference in the mean scores of surgical fear between the groups on the morning of the surgery (p > 0.05). However, a significant difference was found in the mean scores of surgical anxiety between the groups (p < 0.05). In conclusion, patients in the education group who received preoperative brochure-assisted education had lower anxiety compared with the control group.

Evaluation of Two Different Approaches to Health Education (Tailored Leaflet vs Video) on Referral Compliance for Prosthetic Replacement of Missing Teeth Among the Patients at a University Dental Care Center.

PURPOSE: To assess whether a health education video increased prosthodontic treatment demand for replacing missing teeth compared to a traditional health education (IEC) leaflet among patients visiting a university dental care center in Saudi Arabia. MATERIALS AND METHODS: A nonrandomized educational intervention was conducted among patients with missing teeth. A total of 350 participants were divided equally into two health-education intervention groups: leaflet group and video group. Two major variants were ascertained: demand for prosthodontic dental care and awareness (knowledge) about the importance of replacing missing teeth. These two variants were studied for the difference in the scores between base line and at the end of the program (after 3 months). Bivariate analysis was done with chi-square test, McNemar chi-square test, and Wilcoxon matched-pairs tests, and finally binary logistic regression analysis was done. RESULTS: The final analysis included 324 participants. There was improvement in both knowledge and demand for prosthodontic care in both the groups after health education, but a statistically significant improvement in demand for dental care was observed in the video group compared to the leaflet group (42.9% vs 63.2%). Logistic regression analysis identified that missing teeth in the anterior region and being in the video group were two significant factors associated with increased demand for care. CONCLUSIONS: The health education video method was found to be a more effective method compared to leaflets in improving knowledge and demand for replacing missing teeth.

Readability of Patient-Facing Information of Antibiotics Used in the WHO Short 6-Month and 9-Month All Oral Treatment for Drug-Resistant Tuberculosis.

OBJECTIVES: Readability of patient-facing information of oral antibiotics detailed in the WHO all oral short (6 months, 9 months) has not been described to date. The aim of this study was therefore to examine (i) how readable patient-facing TB antibiotic information is compared to readability reference standards and (ii) if there are differences in readability between high-incidence countries versus low-incidence countries. METHODS: Ten antibiotics, including bedaquiline, clofazimine, ethambutol, ethionamide, isoniazid, levofloxacin, linezolid, moxifloxacin, pretomanid, pyrazinamide, were investigated. TB antibiotic information sources were examined, consisting of 85 Patient Information Leaflets (PILs) and 40 antibiotic web resouces. Of these 85 PILs, 72 were taken from the National Medicines Regulator from six countries (3 TB high-incidence [Rwanda, Malaysia, South Africa] + 3 TB low-incidence [UK, Ireland, Malta] countries). Readability data was grouped into three categories, including (i) high TB-incidence countries (n = 33 information sources), (ii) low TB-incidence countries (n = 39 information sources) and (iii) web information (n = 53). Readability was calculated using Readable software, to obtain four readability scores [(i) Flesch Reading Ease (FRE), (ii) Flesch-Kincaid Grade Level (FKGL), (iii) Gunning Fog Index and (iv) SMOG Index], as well as two text metrics [words/sentence, syllables/word]. RESULTS: Mean readability scores of patient-facing TB antibiotic information for FRE and FKGL, were 47.4 ± 12.6 (sd) (target ≥ 60) and 9.2 ± 2.0 (target ≤ 8.0), respectively. There was no significant difference in readability between low incidence countries and web resources, but there was significantly poorer readability associated with PILs from high incidence countries versus low incidence countries (FRE; p = 0.0056: FKGL; p = 0.0095). CONCLUSIONS: Readability of TB antibiotic PILs is poor. Improving readability of PILs should be an important objective when preparing patient-facing written materials, thereby improving patient health/treatment literacy.

The effect of educational animation compared to leaflets on patients' knowledge regarding root canal treatment: a randomized controlled trial.

BACKGROUND: Incorporating video as a tool for education offers a multitude of advantages. However, it is unknown what is the best educational tool to use for increasing public awareness, consequently reducing fear about root canal treatment. For this reason, this study aimed to compare the effectiveness of educational animation and leaflets as delivery methods for providing information on root canal treatment to patients and to assess their ability to retain the information. METHODS: One hundred fifty adult volunteers were recruited via social media and Umm Al-Qura University Dental Hospital to participate in this randomized control trial study. The volunteers were divided into the study group (SG) and the control group (CG). The SG was provided with information through animations created by the research team, while the CG received the same information through a leaflet. Pre-intervention (T1), immediate post-intervention (T2), and one-month post-intervention (T3) validated questionnaires were completed by the participants to assess the changes in their knowledge. To evaluate the impact of the information delivery method, the knowledge scores of T2 and T3 were compared to T1 within each group using Paired T-tests. Additionally, the study compared the knowledge scores of the two groups using unpaired T-tests. The significance level was set at a P-value of less than 0.05. RESULTS: A significant improvement in endodontic therapy knowledge among the participants in both groups (T1 compared to T2 in the same group) was noted (P < 0.050). However, when comparing T2 between groups, no significant difference was found in delivering the information and improving the knowledge (P = 0.080). Still, the mean differences between T1 and T2, as well as T1 and T3, were greater (P < 0.050) in the SG than in the CG. Furthermore, the total knowledge score in the SG at T3 was significantly higher than the CG. CONCLUSION: Both educational animation and leaflets are practical tools to increase patients' awareness about root canal treatment. However, educational videos are more effective than leaflets in delivering and retaining information about root canal treatment. TRIAL REGISTRATION: This study was retrospectively registered as a randomized control trial at the ISRCTN registry with the document number ISRCTN18413241, 15/05/2023.

Written information about retinopathy of prematurity in Aotearoa New Zealand: identification, review and opportunities for improvement.

AIMS: The aims of this research include adapting a patient information tool for whanau (extended family) Maori needs, identifying and reviewing written information provided for the retinopathy of prematurity eye examination (ROPEE) and identifying improvements to ROPEE written information. METHODS: ROPEE patient information (printed leaflets, website, app) was obtained from all tertiary neonatal intensive care units in Aotearoa New Zealand (Aotearoa). Information was reviewed using an adapted "20 good-design principles" guide and given a star rating and Flesch-Kincaid readability score to identify acceptability and usability for patients. RESULTS: Seven ROPEE information materials were reviewed and varied in alignment with the adapted good-design principles tool. Based on the adapted good-design principles, opportunities were identified in many aspects of the written information for improvement, including words and language, tone and meaning, content and design. The Flesch-Kincaid grade level reading scores ranged from 12-22 years reading age. Written information also did not use te reo Maori (Aotearoa Indigenous language) or extensively use Maori imagery. CONCLUSION: Opportunities exist to improve ROPEE whanau information, including making content more readable, understandable and visually appealing. Optimising the clinical information on ROPEE nationally for Aotearoa will support whanau decision making, and aligning written information with Maori (Indigenous peoples of Aotearoa) is a priority.

Série educativa da fauna sinantrópica: taturana

Folhedo informativo sobre a taturana (lonomia oblíqua)

Série educativa da fauna sinantrópica: barata (periplaneta americana)

Folheto educativo referente à barata: biologia, medidas preventivas e importância para a saúde

Série educativa da fauna sinantrópica: abelha & vespa (apis spp e vespidae)

Folhedo informativo sobre o abelhas e vespas

Evaluation of clinical effectiveness of blood stasis leaflet in patients with blood stasis: A prospective, randomized, and crossover trial.

BACKGROUND: Blood stasis (BS) refers to a pattern of symptoms resulting from circulatory dysfunction or stagnation in the human body. Due to its historical origin and diverse interpretations, communication between patients and doctors of traditional Korean medicine (DKMs) presents challenges. Efforts to improve patients understanding in traditional Korean medicine (TKM) have led to the development of disease-specific standard clinical practice guidelines. However, there is a limited focus on creating clinical practice guidelines or informative leaflet specifically addressing BS, which is a frequently encountered pattern of symptoms in TKM. METHODS: This study aimed to bridge the gap between patients and DKMs by developing an informative leaflet focusing on BS for metabolic diseases. We assessed its appropriateness through expert advisory meetings and the Delphi process, and evaluated its clinical effectiveness. We conducted a prospective, randomized, crossover trial to compare the clinical effectiveness of using BS leaflets in TKM treatment. The hypothesis investigated whether the leaflet group would show higher scores in satisfaction of DKMs' explanations, understanding of DKMs' explanations, improving the reliability of TKM, satisfaction with treatment time, improvement in explanations compared to previous TKM experiences, and necessity of managing BS treatment, compared to the no-leaflet group. RESULTS: In a study involving 40 patients (mean age: 62.3 ±â€…7.8 years), symptoms persisted for an average of 16.75 ±â€…9.3 hours daily, with a severity rating of 2.53. The leaflet group exhibited significantly higher satisfaction scores than the no-leaflet group in all aspects (all P < .0001). After confirming the absence of sequence and period effects using a linear-mixed effect model, we were able to ascertain the presence of a treatment effect, as evidenced by statistically significant higher scores across all survey items in the leaflet group compared to the no-leaflet group (all P < .0001). CONCLUSION: Expert consensus on symptoms aligning with the BS pattern resulted in the development of an informative leaflet. Its utilization notably improved patient satisfaction, comprehension, and trust in TKM treatment, unaffected by temporal influences, thus demonstrating its clinical effectiveness. In summary, the BS leaflet significantly enhanced patient understanding and optimized treatment procedures.

You and Your Baby (home, husband, and doctor): maternal responsibility in the British Medical Association booklet (1957-1987).

You and Your Baby was a pregnancy advice booklet, produced by the British Medical Association (BMA) from 1957-1987. This booklet was provided to expectant mothers in the UK, free of charge, and offered authoritative information on pregnancy, childbirth and caring for infants. Reprinted each year, You and Your Baby captured contemporary maternity policy and advice. But, in addition to the typical information that you might expect about mother and baby health, You and Your Baby advised readers on matters such as maintaining their appearance, marital relations and domestic duties. In this way, it advocated a specific vision of motherhood, with responsibilities to the home and husband. Further to these duties, this article will focus on the balance of responsibilities between pregnant women and their doctors, and how attitudes to trust and authority developed over time. The BMA publication repeatedly warned readers against listening to 'old wives' tales', instead emphasising the importance of accepting (and not questioning) professional medical guidance. Following the thalidomide scandal, however, women were made partially responsible for doctors' professional integrity; women were advised to avoid asking their doctors to prescribe medication that may later prove to be harmful, shifting the responsibility from the healthcare practitioner to the mother. This created an uncomfortable dissonance between the publication's attempts to establish and reinforce medical authority, and yet shift professional responsibility. The booklet series, therefore, posed women as responsible for their doctors, as well as their babies. In summary, this article presents a case study of the You and Your Baby BMA booklet, examining developing healthcare messaging around maternal behaviour and responsibility. It draws attention to supposed responsibilities to the home, husband and doctor and how those responsibilities changed over 30 years.

Trial participants' self-reported understanding of randomisation phrases in participation information leaflets can be high, but acceptability of some descriptions is low, especially those linked to gambling and luck.

BACKGROUND: Evidence indicates that trial participants often struggle to understand participant information leaflets (PILs) for clinical trials, including the concept of randomisation. We analysed the language used to describe randomisation in PILs and determine the most understandable and acceptable description through public and participant feedback. METHODS: We collected 280 PILs/informed consent forms and one video animation from clinical research facilities/clinical trial units in Ireland and the UK. We extracted text on how randomisation was described, plus trial characteristics. We conducted content analysis to group the randomisation phrases inductively. We then excluded phrases that appeared more than once or were very similar to others. The final list of randomisation phrases was then presented to an online panel of participants and the public. Panel members were asked to rate each phrase on a 5-point Likert scale in terms of their understanding of the phrase, confidence in their understanding and acceptability of the phrase. RESULTS: Two hundred and eighty PILs and the transcribed text from one video animation represented 229 ongoing or concluded trials. The pragmatic content analysis generated five inductive categories: (1) explanation of why randomisation is required in trials; (2) synonyms for randomisation; (3) comparative randomisation phrases; (4) elaborative phrases for randomisation (5) and phrases that describe the process of randomisation. We had 48 unique phrases, which were shared with 73 participants and members of the public. Phrases that were well understood were not necessarily acceptable. Participants understood, but disliked, comparative phrases that referenced gambling, e.g. toss of a coin, like a lottery, roll of a die. They also disliked phrases that attributed decision-making to computers or automated systems. Participants liked plain language descriptions of what randomisation is and those that did not use comparative phrases. CONCLUSIONS: Potential trial participants are clear on their likes and dislikes when it comes to describing randomisation in PILs. We make five recommendations for practice.

Retention strategies are routinely communicated to potential trial participants but often differ from what was planned in the trial protocol: an analysis of adult participant information leaflets and their corresponding protocols.

BACKGROUND: Retaining participants in randomised controlled trials (RCTs) is challenging and trial teams are often required to use strategies to ensure retention or improve it. Other than monetary incentives, there is no requirement to disclose the use of retention strategies to the participant. Additionally, not all retention strategies are developed at the planning stage, i.e. post-funding during protocol development, but some protocols include strategies for participant retention as retention is considered and planned for early in the trial planning stage. It is yet unknown if these plans are communicated in the corresponding participant information leaflets (PILs). The purpose of our study was to determine if PILs communicate plans to promote participant retention and, if so, are these outlined in the corresponding trial protocol. METHODS: Ninety-two adult PILs and their 90 corresponding protocols from Clinical Trial Units (CTUs) in the UK were analysed. Directed (deductive) content analysis was used to analyse the participant retention text from the PILs. Data were presented using a narrative summary and frequencies where appropriate. RESULTS: Plans to promote participant retention were communicated in 81.5% (n = 75/92) of PILs. Fifty-seven percent (n = 43/75) of PILs communicated plans to use "combined strategies" to promote participant retention. The most common individual retention strategy was telling the participants that data collection for the trial would be scheduled during routine care visits (16%; n = 12/75 PILs). The importance of retention and the impact that missing or deleted data (deleting data collected prior to withdrawal) has on the ability to answer the research question were explained in 6.5% (n = 6/92) and 5.4% (n = 5/92) of PILs respectively. Out of the 59 PILs and 58 matching protocols that both communicated plans to use strategies to promote participant retention, 18.6% (n = 11/59) communicated the same information, the remaining 81.4% (n = 48/59) of PILs either only partially communicated (45.8%; n = 27/59) the same information or did not communicate the same information (35.6%; n = 21/59) as the protocol with regard to the retention strategy(ies). CONCLUSION: Retention strategies are frequently communicated to potential trial participants in PILs; however, the information provided often differs from the content in the corresponding protocol. Participant retention considerations are best done at the planning stage of the trial and we encourage trial teams to be consistent in the communication of these strategies in both the protocol and PIL.