Background: The rise of digital health services, especially following the outbreak of COVID-19, has led to a need for health literacy policies that respond to people's needs. Spain is a country with a highly developed digital health infrastructure, but there are currently no tools available to measure digital health literacy fully. A well-thought-through questionnaire with strong psychometric properties such as the eHealth Literacy Questionnaire (eHLQ) is important to assess people's eHealth literacy levels, especially in the context of a fast-growing field such as digital health.

Objective: This study aims to adapt the eHLQ and gather evidence of its psychometric quality in 2 of Spain's official languages: Spanish and Catalan.

Methods: A systematic cultural adaptation process was followed. Data from Spanish-speaking (n=400) and Catalan-speaking (n=400) people were collected. Confirmatory factor analysis was used to confirm the previously established factor structure. For reliability, the Cronbach α and categorical ω were obtained for every subscale. Evidence of convergent and discriminant validity was provided through the correlation with the total score of the eHealth Literacy Scale. Evidence based on relations to other variables was evaluated by examining extreme values for educational level, socioeconomic level, and use of technology variables.

Results: Regarding the confirmatory factor analysis, the 7-factor correlated model and the 7 one-factor models had adequate goodness-of-fit indexes for both Spanish and Catalan. Moreover, measurement invariance was established between the Spanish and Catalan versions. Reliability estimates were considered adequate as all the scales in both versions had values of >0.80. For convergent and discriminant validity evidence, the eHealth Literacy Scale showed moderate correlation with eHLQ scales in both versions (Spanish: range 0.57-0.76 and P<.001; Catalan: range 0.41-0.64 and P<.001). According to the relationship with external variables, all the eHLQ scales in both languages could discriminate between the maximum and minimum categories in level of education, socioeconomic level, and level of technology use.

Conclusions: The Spanish and Catalan versions of the eHLQ appear to be psychometrically sound questionnaires for assessing digital health literacy. They could both be useful tools in Spain and Catalonia for researchers, policy makers, and health service managers to explore people's needs, skills, and competencies and provide interesting insights into their interactions and engagement regarding their own experiences with digital health services, especially in the context of digital health growth in Spain.

Purpose: The Multinational Association of Supportive Care in Cancer (MASCC)/European Society of Medical Oncology (ESMO) Patient Antiemetic Guideline Committee aimed to (1) adapt the updated evidence-based, clinical guidelines to patient-centered antiemetic guidelines and (2) develop patient education materials and statements.

Methods: The MASCC 2023 Patient Antiemetic Guidelines were created and reviewed by antiemetic experts and patient advocates by incorporating the 2023 MASCC/ESMO antiemetic guidelines into patient-friendly language. Patient Education Statements were developed based on current literature and by utilizing an expert modified Delphi consensus (≥ 75% agreement). Patient advocate/focus group input and patient survey results were further integrated into Patient-Centered Antiemetic Guidelines and Education Statements.

Results: Patient-Centered Antiemetic Guidelines were created using patient-friendly language and visual slides. Patient-friendly language was also utilized to communicate the Educational Statements. Key content categories identified for the Educational Statements included the following: nausea/vomiting definitions, causes, risk factors, categories, complications, accompanying symptoms, prophylactic antiemetic treatment, general management, when to call/what to ask the healthcare team, what caregivers can do, and available resources. All identified content met the ≥ 75% expert agreement threshold. Fifteen (15) items demonstrated 100% agreement, 11 items achieved ≥ 90% agreement, and three content items demonstrated 80 ~ 82% agreement.

Conclusions: The inaugural MASCC 2023 Patient Antiemetic Guidelines can help patients and caregivers understand the prevention of nausea and vomiting related to their cancer treatment. Educational Statements provide further patient information. Educating patients on how to utilize guideline antiemetics and the education statements can contribute improvements in the control of anticancer treatment-related nausea and vomiting.

Background: Chronic obstructive pulmonary disease (COPD) is a costly chronic disease affecting more than 15 million Americans. The prevalence among US veterans is 3 times higher than the general population.

Local problem: The Veteran Health Administration developed a standardized, evidence-based COPD educational tool called Green Light to Go (GLTG) designed to educate patients on managing their COPD symptoms at home. Despite the availability of this resource, inpatient education on COPD self-management practices is highly variable across different medical teams. This quality improvement (QI) initiative sought to standardize inpatient COPD patient education using the GLTG tool. This initiative also assessed whether patients receiving standardized patient education during their index hospitalization had lower COPD 30-day readmission rates.

Method: The QI initiative followed the LEAN methodology and the A3 framework. The team performed rapid tests of change (plan-do-study-act cycles) to increase the percentage of veterans receiving COPD education.

Interventions: The interventions implemented for this QI initiative focused on clinical, patient, and system improvements.

Results: This initiative standardized COPD patient education and increased the percentage of veterans receiving (a) daily COPD education from 0% to 66%, (b) verbal COPD education on discharge from a baseline of 20% to 100%, (c) receipt of written educational material on discharge from 20% to 100%, and (d) the cohort all-cause 30-day readmission rate declined from 19.3% to 14.3%.

Conclusions: Given the substantial economic burden of COPD readmissions on the health care system and patients, evidence-based educational interventions may potentially improve outcomes and reduce hospital readmissions in this veteran population.

This study aimed to investigate the knowledge of patients with hypertension about their condition, adherence to antihypertensive medication, and the factors influencing it. A cross-sectional study was conducted in two cardiology outpatient clinics of two tertiary hospitals, in Greece. The study included 188 patients diagnosed with hypertension. The patients' knowledge about their disease and adherence to medication were assessed by using the HK-LS and A-14 scales, respectively. Patients had sufficient knowledge levels about their disease, but significantly low levels of adherence to medication. Patients with higher knowledge levels were more adherent to medications [r(188) = 0.885, p < 0.001]. By using multivariate analysis, higher age (p = 0.018), residence in a more populous area (p = 0.041), more years with the disease (p = 0.012), and a lower number of medications (p = 0.03) were associated with higher levels of knowledge. Conversely, younger age (p = 0.036), lower educational levels (p = 0.048), fewer years with the disease (p = 0.001), and a higher number of medications (p = 0.003) were associated with lower adherence to medication. The Greek patients' hypertension knowledge was sufficient; however, adherence to medication was significantly low. Healthcare managers could utilize our findings to design targeted interventions for improving adherence to medication for these patients.

Background: Health literacy is vital during pregnancy, as maternal health knowledge and behavior have a significant impact on the health of both mother and child. Hence, this study aimed to assess the health literacy status of pregnant women diagnosed with gestational diabetes mellitus (GDM), as well as its associated factors and impact on glycemic control.

Materials and methods: The facility-based Cross-sectional analytical study was conducted among 200 pregnant women with GDM in a tertiary care hospital. The eligible participants were consecutively selected for the study. The study was conducted from September 2022 to March 2023. A validated semi-structured questionnaire, the Health Literacy Questionnaire (HLQ) for GDM, was used to measure health literacy status. Stata V.17 software was used for data analysis.

Results: Out of 200 pregnant women with GDM, the mean (SD) age of the participants is 29.5 (±5.5) years. It was observed that 164 (82%) of the participants had adequate health literacy, whereas 36 (18%) had inadequate health literacy about Gestational Diabetes. Adequate health literacy (HL) was observed among 88.5% of women with controlled blood sugar and 55.1% of women with uncontrolled blood sugar. Results of multivariate logistic regression analysis revealed that pregnant mothers' educational status (PR: 1.8; 95% CI: 1.2-2.5) and glycemic control (PR: 1.4; 95% CI (1.2-1.7) were associated with adequate HL.

Conclusions: In conclusion, this study supports the association between adequate HL and glycemic control in pregnant women with GDM. Addressing this gap is essential for healthcare officials and planners to implement programs that promote women's HL during pregnancy, with a focus on low-educated groups.

Introduction: Rotator cuff injuries (RCIs) are incredibly common in the US adult population. Forty-three percent of adults have basic or below-basic literacy levels; nonetheless, patient educational materials (PEMs) are frequently composed at levels exceeding these reading capabilities. This study investigates the readability of PEMs on RCIs published by leading US orthopaedic institutions.

Methods: The top 25 orthopaedic institutions on the 2022 U.S. News & World Report Best Hospitals Specialty Ranking were selected. Readability scores of PEMs related to RCI were calculated using the www.readabilityformulas.com website.

Results: Among the 25 analyzed PEM texts, all exceeded the sixth-grade reading level. Only four of 168 scores (2.4%) were below the eighth-grade level.

Discussion: This study indicates that PEMs on rotator cuff injuries from top orthopedic institutions are too complex for many Americans, with readability levels ranging from 8.5 to 16th grade, well above the CDC-recommended eighth-grade level. The research highlights a widespread issue with high reading levels across healthcare information and underscores the need for healthcare providers to adopt patient-centered communication strategies to improve comprehension and accessibility.

Conclusion: PEMs on rotator cuff injuries from leading orthopedic institutions often have a reading level beyond that of many Americans, exceeding guidelines from the NIH and CDC that recommend PEMs be written at an eighth-grade reading level. To increase accessibility, enhance healthcare literacy, and improve patient outcomes, institutions should simplify these materials to meet recommended readability standards.

Introduction: Health literacy (HL) is a crucial indicator for health promotion and diabetes care improvement, but the available measurements are mostly in English. This study aimed to translate and validate the 14-item Health Literacy Scale (HLS-14) questionnaire from English to Vietnamese for patients with diabetes in Vietnam.

Methods: We translated HLS-14 into Vietnamese in accordance with the World Health Organization guidelines and conducted a cross-sectional survey among 571 outpatients with type 2 diabetes using the HLS-14 Vietnamese version (HLS-14 VN). The reliability and validity of the tool were assessed using Cronbach's alpha, composite reliability (CR), average variance extracted (AVE), and maximum shared variance (MSV), and confirmatory analysis was conducted.

Results: Cronbach's alpha coefficients for the three subscales as in the original version were 0.931, 0.810, and 0.928 for functional HL, communicative HL, and critical HL, respectively. However, AVE for critical HL was 0.488, which improved to 0.516 after the removal of one item in the communicative HL. For all subscales in the revised 13-item version (HLS-13 VN), CR was above 0.8, AVE was above 0.5, and MSV was less than AVE. Confirmatory analysis of HLS-13 VN revealed an acceptable fit with comparative fit index of 0.983, goodness-of-fit index of 0.963, and root mean squared error of approximation of 0.058.

Conclusions: The reliability and validity of HLS-13 VN were confirmed. The tool is suitable for use in clinical settings in Vietnam to assess multidimensional HL in patients with type 2 diabetes.

Objectives: While the internet provides accessible medical information, often times it does not cater to the average patient's ability to understand medical text at a 6th and 8th grade reading level, per American Medical Association (AMA)/National Institute of Health (NIH) recommendations. This study looks to analyze current online materials relating to posterior cruciate ligament (PCL) surgery and their readability, understandability, and actionability.

Methods: The top 100 Google searchs for "PCL surgery" were compiled. Research papers, procedural protocols, advertisements, and videos were excluded from the data collection. The readability was examined using 7 algorithms: the Flesch Reading Ease Score, Gunning Fog, Flesch-Kincaid Grade Level, Coleman-Liau Index, SMOG index, Automated Readability Index and the Linsear Write Formula. Two evaluators assessed Understandability and Actionability of the results with the Patient Educational Materials Assessment Tool (PEMAT). Outcome measures included Reading Grade Level, Reader's age minimum and maximum, Understandability, and Actionability.

Results: Of the 100 results, 16 were excluded based on the exclusion criteria. There was a statistically significant difference between the readability of the results from all algorithms and the current recommendation by AMA and NIH. Subgroup analysis demonstrated that there was no difference in readability as it pertained to which page they appeared on Google search. There was also no difference in readability between individual websites versus organizational websites (hospital and non-hospital educational websites). Three articles were at the 8th grade recommended reading level, and all three were from healthcare institutes.

Conclusion: There is a discrepancy in readability between the recommendation of AMA/NIH and online educational materials regarding PCL surgeries, regardless of where they appear on Google and across different forums. The understandability and actionability were equally poor. Future research can focus on the readability and validity of video and social media as they are becoming increasingly popular sources of medical information.

Background: Health literacy involves individuals' knowledge, personal skills, and confidence to take action to evaluate and appraise health-related information and improve their health or that of their community.

Objective: This study aimed to analyze the association between health literacy and attitude toward vaccines, adjusted with other factors.

Methods: We used the SLAVACO Wave 3, a survey conducted in December 2021 among a sample of 2022 individuals, representative of the French adult population. We investigated factors associated with the attitude toward vaccines using respondents' different sociodemographic data, health literacy levels, and the health care system confidence levels using a multinomial logistic regression analysis.

Results: Among the participants, 440.4 (21.8%) were classified as "distrustful of vaccines in general," 729.2 (36.1%) were "selectively hesitant," and 852.4 (42.2%) were "nonhesitant." In our model, the level of health literacy was not statistically different between the "distrustful of vaccines in general" and the "selectively hesitant" (P=.48), but it was associated with being a "nonhesitant" (adjusted odds ratio [aOR] 1.86, 95% CI 1.25-2.76). The confidence in the health care system was a strong predictor for a "nonhesitant" attitude toward vaccines (aOR 12.4, 95% CI 7.97-19.2). We found a positive correlation of 0.34 (P<.001) between health literacy and confidence in the health care system, but the interaction term between health literacy and health care system confidence was not significant in our model.

Conclusions: Health literacy was associated with a "nonhesitant" attitude toward vaccines. The findings demonstrated that health literacy and confidence in the health care system are modestly correlated. Therefore, to tackle the subject of vaccine hesitancy, the main focus should be on increasing the population's confidence and on increasing their health literacy levels or providing vaccine information addressing the needs of less literate citizens.

Introduction: People being investigated for cancer face a wealth of complex information. Non-specific symptom pathways (NSS) were implemented in the United Kingdom in 2017 to address the needs of patients experiencing symptoms such as weight loss, fatigue or general practitioner 'gut feeling', who did not have streamlined pathways for cancer investigation. This study aimed to explore the health literacy skills needed by patients being investigated for cancer in NSS pathways.

Methods: This study employed ethnographic methods across four hospitals in England, including interviews, patient shadowing and clinical care observations, to examine NSS pathways for cancer diagnosis. We recruited 27 patients who were shadowed and interviewed during their care. We also interviewed 27 professionals. The analysis focused on patient communication and understanding, drawing on the concepts of personal and organisational health literacy.

Results: Our analysis derived six themes highlighting the considerable informational demands of the NSS pathway. Patients were required to understand complex blood tests and investigations in primary care and often did not understand why they were referred. The NSS pathway itself was difficult to understand with only a minority of patients appreciating that multiple organs were being investigated for cancer. The process of progressing through the pathway was also difficult to understand, particularly around who was making decisions and what would happen next. The results of investigations were complex, often including incidental findings. Patients whose persistent symptoms were not explained were often unsure of what to do following discharge.

Conclusion: We have identified several potential missed opportunities for organisations to support patient understanding of NSS pathways which could lead to inappropriate help-seeking post-discharge. Patients' difficulties in comprehending previous investigations and findings could result in delays, overtesting or inadequately targeted investigations, hindering the effective use of their medical history. Third, patients' limited understanding of their investigations and results may impede their ability to engage in patient safety by reporting potential care errors.

Patient or public contribution: Patient, public, clinical and policy representatives contributed to developing the research objectives through a series of meetings and individual conversations in preparation for the study. We have held several events in which patients and the public have had an opportunity to give feedback about our results, such as local interest groups in North London and academic conferences. A clinical contributor (J.-A. M.) was involved in data analysis and writing the manuscript.

Background: Hypertensive disorders of pregnancy are a main cause of maternal morbidity and mortality in the United States and worldwide, and it is estimated that approximately 60% of maternal deaths in the United States occur during the postpartum period. The utilization of telehealth modalities such as home blood pressure monitoring has shown improvement in blood pressure control and adherence with follow up visits. Our study sought to determine if standardized education improved patient hypertension knowledge and if this when combined with home blood pressure telemonitoring increased participants' postpartum self-blood pressure monitoring and postpartum visit attendance.

Methods: This is an Institutional Review Board approved prospective cohort study conducted at the University of Mississippi Medical Center. Women with a hypertensive disorder of pregnancy who met the inclusion criteria and provided written informed consent to participate were enrolled. Participants received a baseline pre-education questionnaire designed to assess their knowledge of their hypertensive diagnosis, hypertension management, and postpartum preeclampsia (PreE). Participants then received standard education, a blood pressure monitor, and were scheduled a follow-up visit during the first 10 days following discharge. Remote home blood pressure monitoring was performed via text messages and voice calls for 6-weeks postpartum. At the conclusion of the study, participants repeated their original questionnaire.

Results: 250 women provided informed consent to participate in the study and were included in this analysis. Relative to the baseline survey, there was a significant increase (p = 0.0001) in the percentage of correct responses. There was not an association between study engagement and percentage of correct responses on end of study questionnaire (p = 0.33) or postpartum visit attendance (p = 0.69). Maternal age was found to drive study engagement, even when adjusted for community-level distress (p = 0.03) and maternal race (p = 0.0002).

Conclusion: Implementing a standardized postpartum education session was associated with improvement in patient's knowledge. Further studies are needed with more longitudinal follow up to assess if this program would also result in improved long-term outcomes and decreased hospital readmission rates.

Trial registration: NCT04570124.

Background: Providing informed consent for trials requires providing trial participants with comprehensive information about the trial, including information about potential risks and benefits. It is required by the ethical principle of respecting patient autonomy. Our study examines the variation in the way information about potential trial benefits and harms is shared in participant information leaflets (PILs).

Methods: A total of 214 PILs and informed consent forms from clinical trials units (CTUs) and Clinical Research Facilities (CRFs) in Ireland and the UK were assessed by two authors independently, to check the extent to which they adhered to seven recently developed principles. Discrepancies were resolved by a third.

Results: Usage of the seven principles varied widely between PILs regardless of the intended recipient or trial type. None of the PILs used more than four principles, and some (4%) used none. Twenty-seven per cent of PILs presented information about all known potential harms, whereas 45% presented information on all known potential benefits. Some PILs did not provide any potential harms or potential benefits (8%). There was variation in the information contained in adult and children PILs and across disease areas.

Conclusion: Significant variation exists in how potential trial benefits and harms are described to potential trial participants in PILs in our sample. Usage of the seven principles of good practice will promote consistency, ensure informed ethical decision-making and invoke trust and transparency. In the long term, a standardised PIL template is needed.

Background Health literacy plays an important role in determining healthcare and medication outcomes. There is a lack of an appropriate, validated scale to assess health literacy status among the Hindi-speaking population. We translated and validated the English version of the All Aspects of Health Literacy Scale (AAHLS) into Hindi. Methods We translated the scale as per WHO guidelines on translation and adaptation of instruments. We did preliminary pilot testing in 30 bilingual subjects and evaluated cross-language concordance of the scale. The final translated scale so obtained after cross-cultural adaptation was tested in a validation study on 130 subjects from the outpatient department of internal medicine in which test-retest repeatability, construct validity, discriminant validity and internal consistency were assessed. Analysis was done using paired t-test, one-way ANOVA, Cronbach α and intra-class correlation coefficient. Results An excellent correlation between Hindi and English versions of the scale for various factors ensured cross-language concordance. Hundred percentage response rate was observed in the validation study. The scale showed good internal consistency (Cronbach α=0.99). The difference in total mean AAHLS score was not statistically significant across different age groups, genders and educational levels. Factor analysis showed a positive correlation among four factors/components of health literacy. For test-retest reliability, the intra-class correlation coefficient for all the items in different factors was significant (range 0.88-1.00; p<0.0001). Significant association of critical literacy sub-scores with functional (r=0.274, p=0.002) and communicative (r=0.283, p=0.001) sub-scores revealed a good construct validity. Conclusion The Hindi translated version of the AAHLS scale is a valid and reliable tool to assess health literacy in the Hindi-speaking population.

Introduction: While telemedicine offers significant benefits, there remain substantial knowledge gaps in the literature, particularly regarding its use in Saudi Arabia. This study aims to explore health consumers' behavioral intention to use telemedicine examining the associated factors such as eHealth literacy and attitudes toward telemedicine services.

Methods: A cross-sectional observational study was conducted to collect data on demographics, health status, internet skills, attitudes toward telemedicine, and eHealth literacy. An online survey was administered at two large public gatherings in Riyadh. The eHEALS-Pl scale was used to measure perceived eHealth literacy levels, and data analysis was performed using SPSS (IBM Corp. United States).

Results: There were 385 participants, with an equal distribution of genders. The largest age group was 18-20 years old (57%). Nearly half of the participants were neither employed nor students, while 43% had access to governmental hospitals through employment. 71% reported proficiency in using the internet. Health-wise, 47% rated their health as excellent, and 56% did not have medical insurance. 87% expressed a high likelihood of using telemedicine if offered by a provider. Participants were categorized based on their eHealth Literacy scores, with 54% scoring low and 46% scoring high. Overall, participants showed positive attitudes toward telemedicine, with 82% agreeing that it saves time, money, and provides access to specialized care. About half of the participants perceived the process of seeing a doctor through telemedicine video as complex. Both eHealth Literacy and attitudes toward telemedicine showed a statistically significant association with the intention to use telemedicine (p < 0.001). There was a positive and significant correlation between eHealth Literacy and attitudes (ρ =0.460; p < 0.001). Multivariate ordinal regression analysis revealed that the odds for a high likelihood of intention to use telemedicine significantly increased with positive attitudes (p < 0.001). Mediation analysis confirmed the significant mediating role of attitudes toward telemedicine in the relationship between eHealth Literacy and the intention to use telemedicine.

Conclusion: The findings underline the importance of enhancing health literacy and consumer attitudes toward telemedicine, particularly during the healthcare digital transformation we are experiencing globally. This is crucial for promoting increased acceptance and utilization of telemedicine services beyond the COVID-19 pandemic.

Objective: The current study delves into the impact of heart failure education intervention on improving therapeutic outcomes for heart failure (HF) patients with reduced nonvalvular ejection fraction.

Methods: There involved a total of 60 HF patients with non-valvular ejection fraction reduction who met the inclusion requirements. Patients enrolled were randomly distributed into an observation group and a control group. The observation group received heart failure education intervention, while the control group received conventional intervention. The therapeutic effect, changes in physical indicators, cardiac function indicators, coagulation function, self-management scale scores, and the incidence of adverse cardiovascular events were meticulously evaluated.

Results: The total effective proportion in the observation group was 96.67%, which was significantly higher than the control group's proportion of 76.67% (p < .05). After treatment, several parameters in the observation group showed significant improvements compared to the control group: hs-CRP, IL-6, LVEDV value, LVESV value, PT value, APTT value, and TT value were all evidently lower in the observation group. Additionally, the cardiac index, LVEF value, and heart failure self-management scale fraction were significantly higher in the observation group compared to the control group (p < .05). Furthermore, the incidence of adverse cardiovascular events in the observation group was only 6.67%, which was significantly lower than the control group's incidence of 20.00% (p < .05).

Conclusion: Heart failure education intervention demonstrates effectiveness in improving the therapeutic outcomes for HF patients and reduced nonvalvular ejection fraction. Additionally, it enhances patients' self-management abilities. Given these positive results, it is highly recommended to promote and implement HF education intervention in clinical practice.

Introduction: Perception of illness (PI) and self-medication (SM) have been thoroughly explored in the existing literature. However, there is a lack of understanding about the mediating effect of health literacy on PI and SM in a non-homogenous population like Saudi Arabia. As such, primary healthcare nurses who have constant interaction with the outpatients have difficulty addressing self-medication. This study aimed to investigate health literacy as mediator between PI and SM among outpatients in the Kingdom of Saudi Arabia (KSA).

Methods: This study employed a cross-sectional approach and was conducted at 10 major primary healthcare (PHC) clinics serving 30 million individuals in 13 different regions of KSA. The 424 outpatients who participated in this study were selected through convenience sampling. Data collection started in November 2022 and concluded in February 2023.

Results: The mean of the Brief Health Literacy Screening Tool, self-medication scale (SMS), and PI scores were 13.01 ± 3.32, 27.46 ± 7.01, and 45.56 ± 7.69, respectively. There was a significant relationship between the age and BRIEF scores (p = 0.039), and the level of education was significantly related to all variables, as were nationality and BRIEF scores (p = 0.001). Finally, occupation was significantly related to BRIEF and SMS scores (p = 0.001 and 0.003, respectively). Completing college and being non-Saudi had positively significant effects on health literacy (p < 0.01). The structural equation model (SEM) found no effect of PI on health literacy or SM behaviour (p = 0.263 and 0.84, respectively), but health literacy did have an effect on SM behaviour (p<0.001).

Conclusion: Health literacy is an important factor in self-medication behavior and that PI is not directly related to health literacy or self-medication behavior, but that health literacy does influence self-medication behavior. Therefore, primary healthcare givers should promote public health literacy alongside the control of other conditions as one of the most effective ways to decrease the prevalence of self-medication and the risks associated with it.

Background: Self-management education programmes are cost-effective in helping people with type 2 diabetes manage their diabetes, but referral and attendance rates are low. This study reports on the effectiveness of the Embedding Package, a programme designed to increase type 2 diabetes self-management programme attendance in primary care.

Methods: Using a cluster randomised design, 66 practices were randomised to: (1) a wait-list group that provided usual care for nine months before receiving the Embedding Package for nine months, or (2) an immediate group that received the Embedding Package for 18 months. 'Embedders' supported practices and self-management programme providers to embed programme referral into routine practice, and an online 'toolkit' contained embedding support resources. Patient-level HbA1c (primary outcome), programme referral and attendance data, and clinical data from 92,977 patients with type 2 diabetes were collected at baseline (months - 3-0), step one (months 1-9), step 2 (months 10-18), and 12 months post-intervention. An integrated ethnographic study including observations, interviews, and document analysis was conducted using interpretive thematic analysis and Normalisation Process Theory.

Results: No significant difference was found in HbA1c between intervention and control conditions (adjusted mean difference [95% confidence interval]: -0.10 [-0.38, 0.18] mmol/mol; -0.01 [-0.03, 0.02] %). Statistically but not clinically significantly lower levels of HbA1c were found in people of ethnic minority groups compared with non-ethnic minority groups during the intervention condition (-0.64 [-1.08, -0.20] mmol/mol; -0.06% [-0.10, -0.02], p = 0.004), but not greater self-management programme attendance. Twelve months post-intervention data showed statistically but not clinically significantly lower HbA1c (-0.56 [95% confidence interval: -0.71, -0.42] mmol/mol; -0.05 [-0.06, -0.04] %; p < 0.001), and higher self-management programme attendance (adjusted odds ratio: 1.13; 95% confidence interval: 1.02, 1.25; p = 0.017) during intervention conditions. Themes identified through the ethnographic study included challenges for Embedders in making and sustaining contact with practices and providers, and around practices' interactions with the toolkit.

Conclusions: Barriers to implementing the Embedding Package may have compromised its effectiveness. Statistically but not clinically significantly improved HbA1c among ethnic minority groups and in longer-term follow-up suggest that future research exploring methods of embedding diabetes self-management programmes into routine care is warranted.

Trial registration: ISRCTN23474120, registered 05/04/2018.

Background: Allergic rhinitis is a chronic respiratory disorder that significantly impacts patients' quality of life (QoL) and work performance. Pharmacists are recognized as suitable professionals to provide patient education and pharmaceutical care for managing allergic rhinitis patients. However, local clinical practice guidelines, particularly regarding pharmaceutical care in public healthcare institutions, are lacking. This study protocol outlines a randomized controlled trial (RCT) designed to evaluate the effectiveness of a pharmacist-led educational model (AR-PRISE Model) in managing allergic rhinitis in adult patients compared to standard pharmaceutical care. The AR-PRISE model delivers patient educational material and a pharmaceutical care algorithm.

Method: This is a 6-month, single-center, prospective, randomized, two-arm, and parallel-group controlled trial. The trial recruits patients attending the otorhinolaryngology clinics of a tertiary referral hospital. Participants are randomized into control or intervention groups in a 1:1 ratio using permuted block randomization. The total number of participants estimated is 154, with each group requiring 77 participants. The control group receives standard pharmaceutical care, while the intervention group receives pharmacist-led education according to the AR-PRISE model. Both groups are assessed for middle turbinate endoscopy findings, disease severity, knowledge level, symptom control, medication adherence, and QoL at baseline and the end-of-study follow-up (day 180 ± 7). Depending on feasibility, intermediate follow-ups are conducted on days 60 ± 7 and 120 ± 7, either virtually or face-to-face. During intermediate follow-ups, participants are assessed for symptom control, medication adherence, and QoL. The intention-to-treat analysis includes all participants assigned to each group. An independent T-test compares the mean difference in knowledge level between the two groups. A two-way repeated measures ANOVA analysis is employed to determine between-group differences for scores of symptom control, adherence rate, and QoL. A P-value < 0.05 is considered statistically significant.

Discussion: This study protocol will provide a framework for conducting a randomized controlled trial (RCT) to evaluate the effectiveness of pharmacist-led education intervention in managing allergic rhinitis within public healthcare settings. The parameters measured in this trial will quantify outcomes associated with improvements in symptoms and QoL. By systematically assessing these outcomes, we aim to contribute valuable insights into the role of pharmacist-led interventions in enhancing the management of allergic rhinitis in public healthcare settings.

Trial registration: ClinicalTrials.gov NCT06027736 . Registered on 9 July 2023-retrospectively registered.

Background: Workplace mental health is an important global health concern.

objectives: This unblinded, phase-III, wait-listed cluster randomized controlled trial aimed to examine the effectiveness of a mobile health (mHealth) psychoeducation program using a spaced education approach on mental health literacy (MHL) in the workplace. The main interest of this paper was the immediate and 3-month medium-term effect of the program on the MHL of workers. The purposely built mHealth platform was also evaluated as a health-related app.

Methods: The mHealth platform was designed using the principle of spaced education as a psychoeducation intervention program, with various modules of web-based and mobile materials presented to the participant in a progressive manner. Short quizzes at the end of each module ensured adequate learning, and successful completion qualified the learner to progress to the next level. The trial recruited 456 employees of specific industries with high levels of work-related stress. Participants who were nested in different offices or units were allocated into the intervention and wait-listed control groups using a block randomization process, with the office or unit as the cluster. A separate sample of 70 individual raters were used for the evaluation of the mHealth platform. The Australian National MHL and Stigma Survey and the Mobile Apps Rating Scale were completed through a web-based self-reported survey to assess MHL and evaluate the app. The trial and follow-up data were analyzed by a generalized linear latent and mixed model with adjustments for the clustering effect of work sites and repeated measures.

Results: Of the 456 participants in the trial, 236 (51.8%) responded to the follow-up survey. Most MHL outcomes obtained significant results immediately after the intervention and across time. After adjusting for the clustering effect, the postintervention weighted mean scores were significantly higher in the intervention group than the control group for correct recognition of a mental health problem, help seeking, and stigmatization by 0.2 (SE 0.1; P=.003), 0.9 (SE 0.2; P<.001), and 1.8 (SE 0.4; P<.001), respectively. After adjusting for the clustering effect, significant differences across time were found in help-seeking intention (P=.01), stigmatization (P<.001), and social distancing (P<.001). The evaluation of the mHealth program resulted in average scores of the 4 major domains ranging from 3.8 to 4.2, with engagement having the lowest score.

Conclusions: The mHealth psychoeducation intervention program using this platform had immediate and 3-month medium-term effects of retaining and improving MHL. The platform was evaluated to have satisfactory performance in terms of functionality, aesthetics, information content, and utility in enhancing MHL. It is anticipated that ongoing development in digital health will provide great benefits in improving the mental health of the global population.