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Background: Adherence to adjuvant endocrine therapy (AET) is low in women with breast cancer, which increases the risk of recurrence and mortality. A consistently reported barrier to adherence is low perceived necessity of AET and high concerns. Existing interventions to support medication beliefs have mixed effectiveness and rarely target medication beliefs specifically. We developed an information leaflet with five candidate components aiming to increase necessity beliefs about AET and reduce concerns; (1) diagrams explaining how AET works; (2) icon arrays displaying the benefits of AET; (3) information about the prevalence of side-effects; (4) answers to common concerns and (5) quotes and pictures from breast cancer survivors. Guided by the multiphase optimisation strategy (MOST), we aimed to optimise the content of the information leaflet. We planned for the dataset to be open access to provide an exemplar for other investigators to use. Methods: The content of the leaflet was optimised in a fully powered online 2 5 factorial experiment. Each candidate component of the leaflet was operationalised as a factor with two levels; on vs off or enhanced vs basic. Healthy women (n=1604) completed the beliefs about medicines questionnaire and were randomised to view one of 32 versions of the information leaflet. The 32 versions comprised unique combinations of the factor levels corresponding to the five candidate intervention components. Time spent on the information leaflet page of the survey was recorded. After viewing the information leaflet, participants completed the beliefs about medicines questionnaire again, a true/false questionnaire assessing their objective knowledge of AET, a subjective rating of their knowledge of AET, and a questionnaire evaluating their satisfaction with the information they received. Importance of this dataset: The factorial dataset provides the opportunity for other investigators interested in using the MOST framework to learn about complex factorial designs, using a real dataset.

Most women with breast cancer are treated with adjuvant endocrine therapy (AET) to reduce the chance of breast cancer coming back. However, many women do not take the medication as recommended. Women's beliefs about the medication are a common reason for not taking AET. Some women do not think AET will help them, and some women have lots of concerns about AET. At the moment, we do not know the best way to change women's beliefs about AET. Therefore, we ran a study to help us understand what combination of information might help change women's beliefs about AET. We developed a written information leaflet with five parts; (1) diagrams about how AET works; (2) visual figures of the benefits of AET; (3) information about how likely each side-effect is; (4) answers to common concerns about AET; and (5) pictures and quotes from women who have taken AET. In an online survey, 1,604 healthy women answered questions about their beliefs about the medication. Each woman was shown one version of the information leaflet picked at random. There were 32 possible versions of the information leaflet, which contained unique combinations of the five parts of the leaflet. After women read the leaflet, they were asked to complete the same questionnaire about their beliefs about the medication. They were also asked questions about how satisfied they were with the information they received, true or false questions about AET to assess their knowledge after reading the leaflet, and a rating of how informed they felt about AET. We also recorded how long women spent looking at the leaflet. One of our aims was to make the dataset from this experiment openly available so other scientists could use it to learn how to conduct similar experiments.

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PURPOSE: Large language models (LLMs) are a form of artificial intelligence (AI) that uses deep learning techniques to understand, summarize and generate content. The potential benefits of LLMs in healthcare is predicted to be immense. The objective of this study was to examine the quality of patient information leaflets (PILs) produced by 3 LLMs on urological topics. METHODS: Prompts were created to generate PILs from 3 LLMs: ChatGPT-4, PaLM 2 (Google Bard) and Llama 2 (Meta) across four urology topics (circumcision, nephrectomy, overactive bladder syndrome, and transurethral resection of the prostate). PILs were evaluated using a quality assessment checklist. PIL readability was assessed by the Average Reading Level Consensus Calculator. RESULTS: PILs generated by PaLM 2 had the highest overall average quality score (3.58), followed by Llama 2 (3.34) and ChatGPT-4 (3.08). PaLM 2 generated PILs were of the highest quality in all topics except TURP and was the only LLM to include images. Medical inaccuracies were present in all generated content including instances of significant error. Readability analysis identified PaLM 2 generated PILs as the simplest (age 14-15 average reading level). Llama 2 PILs were the most difficult (age 16-17 average). CONCLUSION: While LLMs can generate PILs that may help reduce healthcare professional workload, generated content requires clinician input for accuracy and inclusion of health literacy aids, such as images. LLM-generated PILs were above the average reading level for adults, necessitating improvement in LLM algorithms and/or prompt design. How satisfied patients are to LLM-generated PILs remains to be evaluated.

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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.

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Background: This study aimed to investigate whether placebo control is differently disclosed in drug and non-drug randomised clinical trial (RCT) participant information leaflets (PILs) and how this might affect participant blinding and direction of study outcomes. Methods: PILs were obtained from trials registered in the International Standard Randomised Controlled Trial Number database via email. Placebo descriptions in PILs were categorised as Full Disclosure (FD), Partial Disclosure (PD), or Missing Information (MI). Associations between intervention type (drug or non-drug)/placebo disclosure (FD or PD/MI) and participant blinding success/trial outcome direction (positive or non-positive) were examined using a two-sided Fisher's exact test. Results: Of 116 collected PILs, 56 % were for drug trials and 44 % were for non-drug trials. Among them, 88 PILs had the corresponding publications available and 68 reports specified primary outcomes. Drug trials were more likely to fully disclose placebo information than non-drug trials (92.3 % vs. 74.5 %, p < 0.05). However, the success rate of blinding was only reported in 3 out of 88 trial publications (3.4 %), precluding further analysis. Furthermore, there was no significant association between the direction of trial results and the type of intervention or placebo disclosure. Conclusion: Our study findings suggest that drug and non-drug RCTs might differ in the way they reveal placebo control information. Further research is warranted to understand what leads to more common PD of placebo information in non-drug trials than drug trials and to determine the optimal placebo control disclosure in specific trial context.

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BACKGROUND: Falls are a major problem among adults over 60 years. Multiple preventive measures must be taken. Written information leaflets can support the knowledge transfer and positively influence recall of the information provided. OBJECTIVE: The aim was to ensure usefulness and understandability of the information leaflets on home fall prevention from the target groups' perspective. METHODS: A cross-sectional survey study with a feedback questionnaire for patients and relatives was conducted at a university hospital in Austria. Quantitative data analysis and qualitative content analysis according to Schreier were performed. RESULTS: The majority (63.9%) of patients rated the overall impression as "very good". 44.2% of the relatives rated it as "very good" and 23% as "good". The question "appealing design" was the only one with a statistically significant difference between patients and relatives. Subgroup analysis has shown a statistically significant difference between educational groups regarding the questions "easy to read" and "easy to understand". CONCLUSION: It could be shown that the information leaflets were already well tailored to the target group. The few comments regarding understandability were considered to improve the content of the information leaflets. A further evaluation regarding the benefit of the fall prevention leaflets in discharge management should be performed.

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BACKGROUND: Patient information leaflets (PILs) are documents that are standardized in nature and provide guidance for patients or caregivers on the safe and effective use of medicines. Previous evidence suggests that written information is linked to enhancing the amount of information remembered. Currently, patients have become more involved in digital searches for information. However, there is variability in the quality and reliability of information obtained from the web. According to Saudi Food and Drug Authority regulations, pharmaceutical manufacturers are required to supplement each pharmaceutical product entering the Saudi market with a digital leaflet in addition to a paper leaflet. This research aimed to evaluate patients' attitudes and practices towards PILs. METHODS: A cross-sectional study design using an anonymous online self-administered questionnaire was adopted. The study took place in Saudi Arabia between October and December 2022. A convenience sampling strategy was used to recruit the study participants. The questionnaire was adapted from previous research that investigated patient attitudes and practices towards PILs. RESULTS: A total of 463 participants agreed to take part in the study and completed the questionnaire. Physicians were the top utilized source for getting medicine information (92.7%), followed by pharmacists (84.7%), PILs (67.4%), searching the Internet (53.6%), and consulting family and friends (31.7%). About 78% of the participants reported often or always reading PILs for new drugs (78.2%), but this percentage was lower (45.4%) for repeat prescriptions. A positive perception towards PILs was observed among the study participants. While 54.6% of the participants indicated a preference for having both paper and digital information leaflets, 33.3% reported a preference for paper leaflets, and 12% indicated a preference for digital formats. CONCLUSION: Although patients had positive perceptions towards PILs, physicians were the top-consulted source for medicine information. Pharmacists should educate patients about the importance of referring to PILs which can also be accessed electronically in the case of a preference for a digital format, as the quality and reliability of the information obtained from the web cannot be confirmed.

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INTRODUCTION: Hypothyroidism is a condition with an underactive thyroid gland. Since thyroid hormones play a significant role in metabolism, hypothyroidism is often associated with metabolic syndrome. Thus, the patient's awareness regarding metabolic syndrome is crucial. OBJECTIVES: To develop and evaluate a Pictogram-based Patient Information Leaflet (P-PIL) for hypothyroidism with metabolic syndrome. MATERIALS AND METHODS: This is a quasi-experimental study without a control group. The P-PIL was developed and validated using the Lawshe Method, translated, and evaluated with 72 patients (24 patients each for English and regional languages, Kannada and Malayalam). RESULTS: The leaflet's Flesch Reading Ease (FRE) and Flesch-Kincaid Grade Level (FKGL) scores were 62.0 and 7.1, respectively. The Baker Able Leaflet Design (BALD) index of English, Kannada, and Malayalam versions of the P-PIL were 28, 27, and 27, respectively. The user testing of the P-PIL was assessed in 72 patients. The overall mean knowledge assessment scores significantly improved from 52.92 ± 6.90 to 77.92 ± 9.31. The majority of patients, precisely 84.72%, expressed a positive opinion regarding the design and layout of the P-PIL. CONCLUSION: The evaluation results strongly suggest that this P-PIL can be an effective educational tool for hypothyroidism patients with metabolic syndrome.

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BACKGROUND: Adherence to adjuvant endocrine therapy (AET) is low in women with breast cancer. Negative beliefs about the necessity of AET and high concerns are barriers to adherence. PURPOSE: To use the multiphase optimization strategy to optimize the content of an information leaflet intervention, to change AET beliefs. METHODS: We conducted an online screening experiment using a 25 factorial design to optimize the leaflet. The leaflet had five components, each with two levels: (i) diagrams about AET mechanisms (on/off); (ii) infographics displaying AET benefits (enhanced/basic); (iii) AET side effects (enhanced/basic); (iv) answers to AET concerns (on/off); (v) breast cancer survivor (patient) input: quotes and photographs (on/off). Healthy adult women (n = 1,604), recruited via a market research company, were randomized to 1 of 32 experimental conditions, which determined the levels of components received. Participants completed the Beliefs about Medicines Questionnaire before and after viewing the leaflet. RESULTS: There was a significant main effect of patient input on beliefs about medication (ß = 0.063, p < .001). There was one significant synergistic two-way interaction between diagrams and benefits (ß = 0.047, p = .006), and one antagonistic two-way interaction between diagrams and side effects (ß = -0.029, p = .093). There was a synergistic three-way interaction between diagrams, concerns, and patient input (ß = 0.029, p = .085), and an antagonistic four-way interaction between diagrams, benefits, side effects, and concerns (ß = -0.038, p = .024). In a stepped approach, we screened in four components and screened out the side effects component. CONCLUSIONS: The optimized leaflet did not contain enhanced AET side effect information. Factorial experiments are efficient and effective for refining the content of information leaflet interventions.

Adjuvant endocrine therapy (AET) is a medication given to women to stop breast cancer from returning. Many women do not take AET every day or stop taking it before they should. Some women do not take AET because they do not believe it will help them, or they have concerns about the side effects. We ran an online study aiming to create the best information leaflet to help women understand how AET is helpful and to reduce their concerns. The leaflet had five sections; diagrams explaining how AET works, visual pictures of the benefits of AET, information about the side effects, answers to common concerns, and quotes from other women with breast cancer. 1,604 healthy women filled in a questionnaire before and after looking at an information leaflet about AET. Women received different combinations of the five sections of the information leaflet. We found quotes from other women with breast cancer led to more positive beliefs about AET. Some sections of the leaflet worked better in combination, while other sections were worse in combination. Our results led us to remove the detailed side effect information from the leaflet, as in combination with the other sections this negatively affected women's beliefs about AET.

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BACKGROUND: Patients with severe mental illnesses like schizophrenia may benefit from a variety of patient education materials. Despite the availability of various resources, it is essential to assess the extent to which patients can comprehend the materials provided. OBJECTIVE: This study aims to evaluate the reliability and readability of the patient information leaflet (PIL) for schizophrenia. METHOD: A quasi-experimental study was conducted for a period of 6 months in the departments of psychiatry. Patients with a diagnosis of schizophrenia were recruited for the study. A user-testing questionnaire was developed and validated with the help of an expert committee to assess reliability. Later, translated versions of the questionnaire were then administered to the patients based on their language preference and evaluated by test-retest analysis. The readability was assessed using pre-validated and translated versions of the PIL. Initially, baseline scores of patient knowledge were assessed using a reliable user-testing questionnaire. Later, their responses were reassessed again using the same questionnaire after reading the PIL. RESULTS: A total of 45 patients participated in the study. From the total sample, 20 participants were randomly selected for reliability assessment. Intraclass-correlation coefficient (ICC), a statistical tool of reliability, give .6 for Kannada, .7 for Malayalam and 1 for the English version of the questionnaire. The overall patient's knowledge was found to be improved from 50.4 to 76.4 after reading the PIL. CONCLUSION: Patients with schizophrenia were able to comprehend the information available on the PIL. Therefore, further research is needed to determine its efficacy in a larger population.

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Background: Very few extensive studies have measured the prevalence and usage pattern of drug information leaflet (DIL) for oral non-prescription drugs (ONPDs) or identified the associated risk factors for not reading DIL among university students in the UAE. Objective: The current study aimed to estimate the prevalence of the usage pattern of DIL for ONPDs, and delineate the associated risk factors for not reading the DIL among university students. Methods: A cross-sectional survey-based multistage sampling technique conducted among 2875 students at three major universities in UAE. The self-administered validated questionnaire was constructed and developed based on Andersen's behavioral model. Binomial logistic regression performed to ascertain the effects of 25 potential predictors on the likelihood that participants not reading (discarded) the DIL after reading them. The primary outcome measure was reading (discarding without reading) the DIL, and the associated behaviours. Results: 2875 university students were eligible to participate in the study, but only 2519 students agreed to participate, indicating an 88% of intent participation. However, only 2,355 (81.9%) students completed the questionnaire. 1348 respondents reported using NPD (response rate 46.9%) during the past three months before conducting the study, which comprised the sample analysis (1307 were excluded). More than three-quarters of them read the DIL (always or often) at the first use (1049 of 1348, 77.8%). Approximately a quarter of those who read the DIL reported that they discarded them after reading (24.1%). The survey has identified four risk factors for not reading the DIL: those who get the drug information from physicians or pharmacists had lower odds of discarding the DIL (odds ration [OR] = 0.491, 95% confidence interval [CI]: 0.273-0.884, p value< 0.05). Medical students had lower odds of discarding the DIL (OR = 0.598, 95% CI: 0.412-0.868, p value< 0.05). Those participants who believe that NPDs are as effective as prescription drugs had lower odds of discarding the DIL (OR = 0.342, 95% CI: 0.123-0.948, p value< 0.05). Participants who use more than one NPD to treat a single symptom a day have higher odds of discarding the DIL (OR = 1.625, 95% CI: 1.122 -2.355, p value< 0.05). Conclusion: The prevalence of drug usage pattern in this population was 57.5% as 1348 subjects reported using NPD during the past 90 days before conducting the study. We have identified four risk factors for not reading the DIL, those who get the drug information from physicians or pharmacists, medical students, those respondents who believe that NPDs were as effective as prescription drugs, and respondents self-treating a single symptom with more than one NPD. It was evident from the findings that usage pattern of NPD for DIL varied among the students, with no specific pattern dominating.

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Background: Very few extensive studies have measured the prevalence and usage pattern of drug information leaflet (DIL) for oral non-prescription drugs (ONPDs) or identified the associated risk factors for not reading DIL among university students in the UAE. Objective: The current study aimed to estimate the prevalence of the usage pattern of DIL for ONPDs, and delineate the associated risk factors for not reading the DIL among university students. Methods: A cross-sectional survey-based multistage sampling technique conducted among 2875 students at three major universities in UAE. The self-administered validated questionnaire was constructed and developed based on Andersen’s behavioral model. Binomial logistic regression performed to ascertain the effects of 25 potential predictors on the likelihood that participants not reading (discarded) the DIL after reading them. The primary outcome measure was reading (discarding without reading) the DIL, and the associated behaviours. (AU)

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Airway deposition of aerosol drugs is highly dependent on the breathing manoeuvre of the patients. Though incorrect exhalation before the inhalation of the drug is one of the most common mistakes, its effect on the rest of the manoeuvre and on the airway deposition distribution of aerosol drugs is not explored in the open literature. The aim of the present work was to conduct inhalation experiments using six dry powder inhalers in order to quantify the effect of the degree of lung emptying on the inhalation time, inhaled volume and peak inhalation flow. Another goal of the research was to determine the effect of the exhalation on the aerodynamic properties of the drugs emitted by the same inhalers. According to the measurements, deep exhalation before drug inhalation increased the volume of the inhaled air and the average and maximum values of the inhalation flow rate, but the extent of the increase was patient and inhaler specific. For different inhalers, the mean value of the relative increase in peak inhalation flow due to forceful exhalation was between 15.3 and 38.4% (min: Easyhaler®, max: Breezhaler®), compared to the case of normal (tidal) exhalation before the drug inhalation. The relative increase in the inhaled volume was between 36.4 and 57.1% (min: NEXThaler®, max: Turbuhaler®). By the same token, forceful exhalation resulted in higher emitted doses and smaller emitted particles, depending on the individual breathing ability of the patient, the inhalation device and the drug metered in it. The relative increase in the emitted dose varied between 0.2 and 8.0% (min: Foster® NEXThaler®, max: Bufomix® Easyhaler®), while the relative enhancement of fine particle dose ranged between 1.9 and 30.8% (min: Foster® NEXThaler®, max: Symbicort® Turbuhaler®), depending on the inhaler. All these effects and parameter values point toward higher airway doses due to forceful exhalation before the inhalation of the drug. At the same time, the present findings highlight the necessity of proper patient education on the importance of lung emptying, but also the importance of patient-specific inhaler-drug pair choice in the future.

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BACKGROUND: The Cleft Lip Education with Augmented Reality (CLEAR) project centers around the use of augmented reality (AR) in patient leaflets, as a visual means to overcome the "health literacy" gap. This trial followed Virtual Reality (VR CORE) guidelines for VR Phase 2 (Pilot) trials. METHODS: Participants included families of children treated for Cleft Lip and Palate at the Royal Hospital for Children, Glasgow. Interventions were AR leaflet or Traditional Leaflet. Objectives were to calculate sample sizes, assess outcome instruments, trial design, and acceptability to patients. Primary outcome measure was Mental Effort Rating Scale, and secondary outcomes were Patient Satisfaction (Visual Analogue Scale), Usefulness Scale for Patient Information Material (USE) scale, and Instructional Materials Motivation Survey (IMMS). Randomization was by block randomization. The trial was single blinded with assessors blinded to group assignment. RESULTS: 12 Participants were randomized, with crossover design permitting analysis of 12 per group. Primary outcome with Mental Effort Rating Scale indicated higher mental effort with Traditional compared to AR Leaflet (4.75 vs 2.00, P = .0003). Secondary outcomes for Satisfaction were Traditional 54.50 versus AR 93.50 (P = .0001); USE scale 49.42 versus 74.08 (P = .0011); and IMMS 112.50 versus 161.75 (P = .0003). Subjective interviews noted overwhelmingly positive patient comments regarding the AR leaflet. Outcome instruments and trial design were acceptable to participants. No harms were recorded. CONCLUSIONS: The CLEAR pilot trial provides early evidence of clinical efficacy of AR leaflets in patient education. It is hoped that this will provide a future paradigm shift in the way patient education is delivered.

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Background: The way information about potential benefits and harms of trial is presented within participant information leaflets (PILs) varies widely and may cause unnecessary 'nocebo' effects. The Medical Research Council (MRC) funded a project that developed seven principles to reduce this variation. However, guidance has not been produced to facilitate the implementation of the principles. Stakeholder involvement is recommended to optimise the way these principles are disseminated and explained. To co-produce recommendations for developing: (1) user-friendly guidance for users of the principles; and (2) resources that support the implementation of the principles. Methods: We held a co-production workshop with representation from the following professional groups: the Health Research Authority (HRA), research ethics committee members, and trial managers. Two rounds of discussions focused on generating recommendations for guidance and resources that support the implementation of the seven principles. Extensive low inference style ethnographic notes were taken, and the data were analysed thematically using deductive codes. The data was collected on October 14, 2022. Results: 25 participants attended a hybrid workshop. Participants recommended that both researchers designing PILs and research ethics committee members should use the principles, and that that they should be simple, mention both benefits and harms explicitly, include examples of visual representations, and provide the evidence base for the principles. Conclusions: We were able to co-produce recommendations for developing and implementing the seven principles within PILs. These recommendations can now be implemented to reduce unexplained variation in the way potential benefits and harms are shared within PILs.

Trial participants need to know about the potential benefits and harms of trial interventions to make an informed decision about whether to take part in a clinical trial. Yet the way they are told about these benefits and harms varies widely. We developed seven principles that can reduced this variability. We held a workshop with members of ethics committees and other stakeholders to develop the best way to implement the principles. 25 participants attended the workshop, and we were able to make useful recommendations that will improve the way trial participants are told about risks and benefits of trial treatments.

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Patient information leaflets are valuable documents that inform and guide users, particularly pregnant women, about medication. Thispaper examined pregnant women's awareness and attitude toward the use of patient information leaflets. Thestudy employed a cross-sectional survey design, using a structured questionnaire for data collection. Purposive sampling technique was used in selecting three public comprehensive health centres in the Ado Local Government Area in Ekiti state, Nigeria,for two weekswhileconvenience sampling technique was used in selecting the patients. Participants included 120 pregnant women who attended antenatal clinics during the antenatal meeting days. Data were collected atthe antenatal clinicsusing a questionnaire. Ninety copies of the questionnaire were returned and found useful for the study. The results showed that most of the pregnant women were aware of the patient information leaflets enclosed in medicine packs and the extent of use was encouraging. The pregnant women had a positive attitude to the patient information leaflet. Also, the respondents had a high level of patient information leaflet use. Reading difficulty (=2.91) was one of the biggest challenges for pregnant women when going through the patient information leaflets. The study also found that pregnant women's awareness and attitudes influenced their use of patient information leaflets. Among other things, it was recommended that health information professionals collaborate with healthcare professionals and pharmaceutical companies to ensure the accuracy, readability and cultural appropriateness of patient information leaflets for pregnant women.

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BACKGROUND: The way information about potential harms of trial intervention is shared within participant information leaflets (PILs) varies widely and can cause subjective 'nocebo' harms. This study aimed to develop principles to improve the composition of information about potential trial intervention benefits and harms within PILs so that variability and avoidable harms are reduced. METHODS: We conducted a two-round modified online Delphi survey, followed by a consensus meeting. For the first round of the survey, 27 statements were developed based on previous research and relevant guidance from the UK, the USA and the World Health Organization. Participants included members from each of the following stakeholder groups: patient and public representatives, research ethics committee members, industry representatives, medico-legal experts, psychologists and trial managers. Each participant was asked to rate their degree of agreement or disagreement with each statement on a 9-point Likert scale. In the second round, participants were invited to reappraise their ratings after reviewing the results of the first round. Finally, two members from each stakeholder group participated in a meeting to confirm those statements for which there was agreement. RESULTS: Two hundred and fifty participants completed round 1, and 201 participants completed round 2. In round 1, consensus was reached for 16 statements. In round 2, consensus was reached for an additional three statements. The consensus meeting confirmed the survey results and consolidated the statements. This process resulted in seven principles: (1) all potential harms of a given intervention should be listed, (2) all potential harms should be separated into serious and less serious, (3) it must be made explicit that not all potential harms are known, (4) all potential benefits should be listed, (5) all potential benefits and harms need to be compared with what would happen if the participant did not take part in the trial, (6) suitable visual representations should be added where appropriate and (7) information regarding potential benefits and harms should not be presented apart by one or more pages. CONCLUSIONS: Our modified Delphi process successfully generated seven principles that can and should be used to guide how information is conveyed to patients in information leaflets regarding potential trial benefits and harms.

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Background: Package leaflet provides information about medicinal product to the user. Printed leaflet is familiar and available, however poorly legible, especially when containing multiple languages. It is resourceful to update, has potential to go missing or get damaged, and is environmentally burdensome. The pharmaceutical manufacturers in the Baltic countries have been granted permission to market selected hospital medicinal products without printed package leaflet. The industrial pilot project is expected to promote availability of medicinal products and patient safety via increased access to medicinal information. Objective: Only few countries in Europe have derogated from Article 58 of Directive 2001/83/EC. Knowledge about the effects of removal of paper package leaflet from the medicinal product is limited, and related publications are scarce. Current interview study is identifying the obstacles during the implementation of the industrial project, investigating the potential environmental impact, and searching for further opportunities for the package leaflet in development of medicinal products. Methods: Real-time person-to-person semi-structured interviews with relevant stakeholders were conducted, and transcripts were analysed by content analysis to identify themes. Results: Results demonstrated general support for removing package leaflet from selected hospital products. Main difficulties of the industrial project regarded the need for clear communication and practical disadvantages of project setup. Main benefits included educational aspect of increasing awareness about product information and strengthened collaboration. Majority of participants felt doubtful about the impact of the industrial project on people's awareness of ecological issues and they admittedly lacked sufficient information on the environmental impact of pharmaceutical packaging. Conclusion: The removal of paper leaflet could be extended to more products based on the positive feedback for the industrial pilot project. However, it is paramount that the format of electronic product information would need to be enhanced first to improve readability.

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Researchers, regulatory agencies, and the pharmaceutical industry are moving towards precision pharmacovigilance as a comprehensive framework for drug safety assessment, at the service of the individual patient, by clustering specific risk groups in different databases. This article explores its implementation by focusing on: (i) designing a new data collection infrastructure, (ii) exploring new computational methods suitable for drug safety data, and (iii) providing a computer-aided framework for distributed clinical decisions with the aim of compiling a personalized information leaflet with specific reference to a drug's risks and adverse drug reactions. These goals can be achieved by using 'smart hospitals' as the principal data sources and by employing methods of precision medicine and medical statistics to supplement current public health decisions.

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BACKGROUND: Recovery following an upper arm break can be prolonged and cause loss of independence. Appropriate information provision to empower and enable active participation in rehabilitation is vital to achieve the best clinical outcomes. OBJECTIVES: To identify and analyse, through the lens of health literacy, publicly available information leaflets produced for patients following upper arm breaks in the United Kingdom National Health Service (NHS) to understand their fitness for purpose. METHOD: An electronic search of online search engines was undertaken using search terms to identify information leaflets for upper arm breaks. Relevant leaflets were retrieved and a thematic analysis was undertaken from a health literacy perspective. To complement this, each information leaflet was also formally assessed for readability. RESULTS: Thirty-five information leaflets were analysed. Two main themes were generated: 'Empowerment' and 'Language Use', with subthemes of promoting recovery, readability and risk of misinterpretation. The information presented in these leaflets was often complicated and sometimes contradictory. Less than half (46%) of the information leaflets were presented at a level that would be understood by the general population. CONCLUSIONS: Current information leaflets made available for patients following upper arm breaks are not fit for purpose and are written in a way that the general population would not readily understand. There is an urgent need to understand the information needs of patients and present such information in an accessible way to optimise clinical outcomes following upper arm breaks.

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BACKGROUND: The European Medicines Agency (EMA) recommends a description of drug side effects based on the frequency format and the associated verbal description. Although the recommendations refer to English-speaking countries, in several non-English-speaking states, official authorities have accepted the proposed recommendations on how the patient information leaflets should be designed for descriptions of side effect frequencies. OBJECTIVE: The aim of the study was to examine how manufacturers of authorized medicines in Poland implement the EMA recommendations regarding the verbal descriptors of the frequency of side effects. METHODS: A qualitative study. As a first step, we identified which of the 150 pharmaceutical companies operating in Poland had the largest market share. Then, five manufacturers were selected at random from the list of the top 15 drug manufacturers in Poland by market share of the pharmaceutical sector. Lists of medicinal products authorized for marketing in Poland were downloaded from manufacturers' websites, and then five products from each manufacturer were selected based on random sampling. The study included only prescription medicines and excluded over-the-counter medicines and dietary supplements from the sample. Subsequently, for each of the 25 drugs, relevant patient information leaflets were obtained from the manufacturers' websites. We evaluated how information on the frequency of side effects was provided in each leaflet, including the use of EMA-recommended terms (verbal descriptors such as 'very common,' 'common,' 'uncommon,' 'rare' and 'very rare') and additional notes explaining their meanings. RESULTS: For all manufacturers, word labels of the frequencies of side effects selected for the study were the same, but the additional notes explaining their meanings were different. There were various explanations of how to understand verbal descriptors of the frequency of side effects not only across different manufacturers but also across different medicines from one manufacturer. CONCLUSIONS: There is no single standard in the Polish pharmaceutical industry for implementing the EMA recommendations into the written information about the frequency of side effects. The observed differences for an explanation of how to understand a given verbal term do not favor a uniform interpretation of the verbal frequency labels meaning by patients.

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