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.

Using artificial intelligence to generate medical literature for urology patients: a comparison of three different large language models.

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.

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.

Patient information leaflet in the era of digitalisation: a cross-sectional study on patients' attitudes and practices.

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.

A critical evaluation of pictogram based patient information leaflet on hypothyroidism patients with metabolic syndrome: a visual approach to enhance health literacy.

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.

Evaluation of psychometric properties of a leaflet developed for schizophrenia.

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.

The effect of exhalation before the inhalation of dry powder aerosol drugs on the breathing parameters, emitted doses and aerosol size distributions.

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.

The Cleft Lip Education with Augmented Reality (CLEAR) VR Phase 2 Trial: A Pilot Randomized Crossover Trial of a Novel Patient Information Leaflet.

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.

Pregnant women awareness and attitude on use of patient information leaflets (PILs) in Ado Local Government, Ekiti State, Nigeria

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.

Could paper package leaflet be left out from hospital products?

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.

An analysis of publicly available National Health Service information leaflets for patients following an upper arm break.

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.

Verbal descriptors of the frequency of side effects: implementation of EMA recommendations in patient information leaflets in Poland.

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.

Factors that Facilitate and Hinder the Comprehension of Patient Information Leaflets (PILs): A Brief Scoping Review.

Introduction: Patient information leaflets (PILs) of medicinal products are informative documents that accompany medicines and explain their components, modes of use, interactions with other medicines, and other relevant issues. When patients do not adequately understand the information in the leaflets, they may engage in behaviors that affect their health (e.g., self-medication). Objective: To identify patient-related factors and characteristics of PILs that can promote cognitive, emotional, and behavioral changes that lead to appropriate drug use practices. Additionally, we aimed to determine strategies that could be implemented to design leaflets that convey adequate information and are easier to understand. Method and Results: We evaluated scientific articles published in databases and containing information on PILs suitability to be used in a patient population. A total of 51 articles were selected as the sample. Certain leaflet factors that favored or hindered understanding were identified (e.g., format in which the leaflets are presented, their structure, their adaptation to the sociodemographic and linguistic characteristics of the population, their wording…). Similarly, we also identified patient factors, such as previous experience taking the drugs referred to in the leaflet; the type of emotions experienced when reading the leaflets; the emphasis on the adverse effects of the medications; sociodemographic variables (i.e., age or educational level); and degree of interest in their own healthcare. Conclusion: Patient and leaflet factors influence the comprehension of information in the PIL; hence, emphasis should be placed on these factors to increase treatment and medication adherence and to reduce health-risk behaviors.

Evaluation of Patient's Knowledge of Atorvastatin Information in Patient Information Leaflets: A Pre-Post Intervention Study in Thailand.

PURPOSE: This study aimed to evaluate the effect of using atorvastatin PIL on patients' medication knowledge, perceptions of the PIL usefulness, their anxiety about the medication, and factors related to these aspects. PATIENTS AND METHODS: A pre-post intervention study was conducted in outpatients at a university hospital. Patients prescribed atorvastatin were enrolled using systematic random sampling. Participants were asked to complete Self-Administered Questionnaire to assess atorvastatin knowledge at baseline. An atorvastatin-PIL produced by the manufacturer was introduced to the participants as the intervention. One month after receiving the PIL, the participants were re-assessed. Ten questions were developed to assess atorvastatin knowledge and visual analog scale (VAS) was used to assess perceived benefits of using the PIL and patient anxiety about the medication. Multiple linear regression was used to assess the related factors. RESULTS: Of 450 questionnaires distributed, 370 were returned. Atorvastatin knowledge significantly increased with mean score of 5.06±1.92 at baseline to 8.34±1.79 at 1-month after intervention. Reading all sections of the PIL (p=0.017) and working for civil service (p=0.006) were associated with higher knowledge scores at baseline and after intervention. Low educational level was associated with lower knowledge scores at baseline (p=0.002), but experience of allergy (p=0.042) was associated with higher knowledge scores after the intervention. Patients had high level of perceived usefulness from the PIL (average scores=8.87±1.83) and low level of anxiety (average scores=3.69±3.06). Reading all sections of the PIL (p=0.007) and taking more than 5 medications (p=0.012) were related to perceived usefulness of the PIL. Females (p<0.001) and herbal supplement users (p=0.048) were related to anxiety about the medication. CONCLUSION: PILs could improve medication knowledge in patients. Patients' perceptions of benefits of PILs were high and anxiety about medication was low. Use of PILs should be encouraged to improve patients' knowledge and appropriate use of medications.

Development and psychometric validation for evaluating written medicine information in Thailand: The Consumer Information Rating Form.

OBJECTIVE: To translate and validate the consumer information rating form (CIRF) for use in Thai populations. DESIGN: The development of the CIRF was carried out in two phases: translation process and cognitive interview, and psychometric testing. SETTING: A university hospital and a tertiary hospital in northeast Thailand. PARTICIPANTS: 150 outpatients from medicine department: 30 for phase 1 and 120 patients for phase 2 study. METHODS: The CIRF was translated with cultural adaptation into Thai using cognitive interview technique in a sample of outpatients. A larger sample of outpatients then completed the CIRF in relation to either a package insert (PI) or a patient information leaflet (PIL) for one of three medicines: atorvastatin, celecoxib and metformin. Construct validity was assessed using principal component analysis (PCA) and internal consistency using Cronbach's α coefficient. Known group validity was assessed by comparing mean consumers' ratings for PIs and PILs. RESULTS: Thirty participants engaged in the cognitive interview and 120 participants completed the CIRF. The PCA found the 17 items of the CIRF were extracted into three factors: comprehensibility, utility and design quality scales, mirroring the original. Cronbach's α for the overall scale (0.904) indicated good internal consistency. Known-group validity demonstrated significant differences in consumers' rating between PIs and PILs for almost all items (p<0.001). CONCLUSION: Thai version of CIRF had acceptable validity and reliability for Thai consumers' ratings of written medicine information. The CIRF could be of practical use in the process of developing medicine information to ensure consumers' comprehension and their usefulness.

Quality of selected anti-retroviral medicines: Tanzania Mainland market as a case study.

BACKGROUND: Antiretroviral drugs (ARVs) have significantly reduced morbidity, mortality and improved the quality of life of people living with HIV infection. Poor quality ARVs may result in harmful consequences such as adverse drug reactions, treatment failure and development of drug resistant strains and sometimes death, which in turn may undermine the healthcare delivery system. To ensure optimal treatment outcomes, medicines quality control must be undertaken regularly. This study was aimed at evaluating the quality of ARVs circulating on the Tanzania Mainland market. METHODS: This was a survey study. ARVs samples were collected in 20 regions of Tanzania Mainland, between 2012 and 2018. All sampled ARVs were subjected to screening testing using the Global Pharma Health Fund® Mini-Lab kits. Sampled ARV's that failed screening test or yielded doubtful results and 10 % (10 %) of all that complied with the screening test requirements were selected for full quality control testing. Quality control testing was conducted at the Tanzania Medicines and Medical Devices Authority (TMDA) laboratory a World Health Organisation prequalified. Samples collected from the medicine distribution outlets were also, subjected to product information review. RESULTS: A total of 2,630 samples were collected, of which 83.7 % (2200/2630) were from port of entry (POEs). All sampled ARVs were screened and conformed to the specifications, except of the fixed dose combination (FDC) lopinavir/ritonavir 0.27 % (7/2630) and lamivudine/zidovudine/nevirapine 0.27 % (7/2630) that failed the disintegration test. Out of the 100 samples selected for full quality control testing, 3 % of them failed to comply with the specifications, of which FDC stavudine/lamivudine/nevirapine failed disintegration and assay tests 2 % (2/100) and 1 % (1/100), respectively. Samples failing the assay test had low content of stavudine (86.6 %) versus specification limits (90 -110 %). Out of the 430 samples which were subjected to product information review, 25.6 % (110/430) failed to comply with the TMDA packaging and labelling requirements. CONCLUSIONS: The quality of majority of ARVs circulating on the Tanzania Mainland market was good, even so, significant deficiencies on labelling and packaging were observed. These results call for continuous monitoring of quality of medicines circulating on the Tanzania Mainland market.

Preparation, validation, and evaluation of an information leaflet for patients undergoing day-care surgeries under general anesthesia at a busy tertiary care hospital.

BACKGROUND AND AIMS: It is essential that patients posted for day-care surgeries are adequately prepared preoperatively. Verbal information alone may not be always effective. This study aimed to prepare, validate, and evaluate the efficacy of a patient information leaflet (PIL) for patients undergoing day-care surgeries under general anesthesia (GA). MATERIAL AND METHODS: After approval from the hospital ethics committee a PIL was prepared in English. Readability and design of the leaflet were checked using standard tests: Flesch readability ease test (FRE), Flesch Kincaid grade level (FKGL), and Baker Able leaflet design (BALD). It was translated into three regional languages. The PIL was tested among patients using a questionnaire. Seventy-nine adult patients posted for elective day-care procedures were included while emergency surgeries were excluded. Patient knowledge pre and post-PIL was compared using paired 't' test. The influence of age, gender, and education level on the usefulness of PIL were analyzed using the Chi-square test and knowledge was compared using ANOVA. RESULTS: The English leaflet had an FRE Score of 63.9 and FKGL of 6.4, which is "standard". The BALD score for all leaflets was 25 ("above standard"). The overall knowledge scores significantly improved from 52.6% (preintervention) to 70.7% (postintervention), P < 0.001. Knowledge improvement was seen with the use of PIL in all four languages. Sixty eight percent of patients strongly recommended the PIL while 31% were willing to recommend it to others. CONCLUSION: The PILs developed in this study have standard readability, good design and validated for efficacy.

Development and validation of patient information leaflet for coronary heart disease patients.

BACKGROUND: Patient information leaflets (PILs) are effectively used to improve the patient's knowledge about medications, disease, diet, and lifestyle modifications. AIM: This study aims to develop and evaluate PILs for coronary heart disease patients. MATERIALS AND METHODS: Primary, secondary, and tertiary resources were used to develop PILs. The developed PILs were validated by four doctors, four academic pharmacists, and one dietician. PILs design and layout was prepared using barker able leaflet design (BALD) criteria. PILs readability was assessed using the Flesch Reading Ease test (FRE), Flesch-Kincaid Grade Level (FKGL), and user readability methods. User opinion on PILs content and design was obtained from patients. RESULTS: The FRE and FKGL readability scores were 61.5 and 7.4, respectively. The BALD criteria scores for English, Kannada, and Malayalam PILs were 28, 27, and 26, respectively. The overall user testing readability means scores had significantly improved from 45 to 79.30. Nearly 82.55% of patients rated the PILs as good design and content. CONCLUSION: The developed leaflet met the standard criteria for easy reading and comprehension. The majority of the patients gave good opinion on the content and design of the PILs.

Improving meningococcal MenACWY and 4CMenB/meningococcal group B vaccine-related health literacy in patients: Importance of readability of pharmaceutical Patient Leaflets.

WHAT IS KNOWN AND OBJECTIVE: Patient information leaflets (PILs) or Patient Leaflets (PLs) formally accompany dispensed medicines and are intended to provide the patient with information on how to use the medicine safely. To date, there have been no studies that have examined the readability of meningococcal vaccine patient-facing information, including information contained within the vaccine PIL. Given the role of pharmacists in presenting PILs to patients, it was, therefore, the aim of this study to quantitatively analyse the readability of Patient Leaflets, which accompany licensed meningococcal vaccines in the UK and US and to compare PILs to vaccine pharmaceutical manufacturers' summary of product characteristics (SPC), as well as other patient-facing vaccine-related information. METHODS: Five sources of meningococcal vaccine information were examined for the licensed meningococcal vaccines in the UK (Bexsero, Menveo, Menitorix, Trumenba, Nimenrix & NeisVac-C) and in the United States (Bexsero, Menveo, Trumenba, Menactra, Menomune-A/C/Y/W-135, Menquadfi), including as follows: (i) SPC (Electronic Medicines Compendium, UK), (ii) Package Insert (FDA; USA), (iii) Patient Leaflet (Electronic Medicines Compendium, UK), (iv) Vaccine pharmaceutical websites and (v) government web resources. Readability was examined employing 10 readability metrics, including the Flesch Reading Ease and the Flesch-Kincaid Grade level. RESULTS AND DISCUSSION: The information source with the greatest readability scores was the UK Patient Leaflet, which had a mean Flesch Reading Ease score of 58.1 and a mean Flesch-Kincaid Grade score of 7.3, followed by the US Department of Health & Human Services patient-facing website for vaccines (55.9 & 8, respectively), followed by the US Centers for Disease Control and Prevention Vaccine Information Statement (47.3 & 9.4, respectively). Pharmaceutical patient-facing websites for meningococcal vaccines had mean scores of 44.6 and 9.9, respectively. When compared with UK Patient Leaflets, pharmaceutical websites were statistically different with poorer readability with both Flesch Reading Ease and Flesch-Kincaid Grade Level indices (p = 0.02 & p = 0.04, respectively). WHAT IS NEW AND CONCLUSION: Pharmaceutical meningococcal vaccine PILs were easily read and had statistically significant good readability scores in comparison with vaccine SPCs and US Package Inserts, pharmaceutical product websites and other government patient-facing meningococcal vaccine information. Preparation of patient-facing materials of a complex topic, such as describing meningococcal vaccines, is difficult to accomplish. Although there is a plurality of sources of information through websites and social media, PILs are one of the few sources that are provided directly to patients. This underpins the potential importance of PILs and the importance of their readability. Adoption of readability calculators and scrutiny of materials for their readability will help authors develop materials with improved understanding for vaccine recipients, potentially leading to improved health literacy and vaccine uptake. Renewed efforts should be sought to promote the information within the PIL, thereby maximizing the value of this resource with vaccine recipients, their carers and family.

Development of patient information leaflets for fixed, removable, and functional appliances for Arabic-speaking orthodontic patients.

OBJECTIVE: To develop Orthodontic Patient Information Leaflets (PILs) in Arabic. MATERIAL & METHOD: This study included five phases starting with Arabic translation of existing British Orthodontic Society leaflets; initial face validation with three orthodontists; content validation with ten orthodontists; final face validation with ten orthodontists, five postgraduate students, and ten patients; and re-translation to English prior to comparing the new documents with the original PILs to verify that all the necessary information were included. The content validity index (CVI) assessed item level (I-CVI) and scale level (S-CVI). RESULTS: The three Arabic PILs were face validated with inclusion of mini-screws, rapid maxillary expansion, and interproximal reduction. Content validity was perfect with no item I-CVI < 0.80. The S-CVI/Ave for PIL Fixed Appliances = 0.98, PIL Removable Appliances = 0.98 and PIL Functional Appliances = 0.97. In the final face validation, the three leaflets received 100% agreement from all observers for consistency of leaflet format and style, clarity, readability and use of adequate phrases. Finally, the leaflets were re-translated and the information was checked by native English speakers to ensure the completeness of information. There were no discrepancies and face validity was excellent. CONCLUSION: Valid PILs for Arabic-speaking patients undergoing orthodontic treatment with fixed, removable, and functional appliances have been developed.