Patient information leaflets and package inserts of ibuprofen provided in the UK and Thailand: a comparative assessment.

OBJECTIVES: Written medicine information (WMI) is important for ensuring patients understand and use their medicines optimally, but relatively little research has assessed the quality of available WMI. This study assessed the quality of WMI using a sample of leaflets for ibuprofen in the UK and Thailand. METHODS: Leaflets were obtained by purchasing a product from retail outlets or community pharmacies, 18 from each country. In the UK, these were patient information leaflets (PILs); in Thailand, they were package inserts PIs not specifically designed for patients. Leaflets were assessed for content, layout, and readability using standard methods and compared to relevant guidelines. KEY FINDINGS: The UK PILs were uniform and conformed to EU regulatory requirements for content, whereas Thai PIs varied considerably, many failing to include important information required by Thai regulations. Several forms of Thai PIs were found, including some very short leaflets, containing minimal information. The readability of both was rated as poor, all used small font size and had less than desirable white space. Fewer Thai PIs than UK PILs met the Keystone Criteria for ibuprofen. CONCLUSIONS: The extent of variation in format and content of Thai WMI could potentially cause confusion and reduce willingness to read it. PILs, conforming to Thai regulatory guidelines, should be provided with medicines instead. Leaflets in both countries would benefit from improved readability and layout.

Patients' Experiences and Preferences for Medicine Information: An International Comparison Between Malaysia, Thailand, Uganda, and England.

Background: Verbal and written medicine information are available to the public but the quality, ease of access, ease of understanding and use of these resources varies greatly between countries. Timely access to quality medicine information is essential to support patient safety. Objective: This international cross-sectional survey, conducted in low-to high-income countries, aimed to compare experiences of and preferences for medicine information sources among respondents with recent medicine use. Methods: The survey was originally developed in England (Kent), then adapted and translated for use in southern Thailand (Songkhla), Malaysia (Klang Valley), and central Uganda (Kampala). Data were analysed using simple descriptive statistics and Chi-squared tests. Results: A total 1588 respondents were involved in the study. Community pharmacies were the primary source of medicines in all four countries (40.7 to 65.3%). Most respondents (1460; 92%) had received at least one form of information with their medicine, but provision of written medicine information (WMI) varied between countries. A manufacturer's leaflet was the most frequent information source for patients in England, while verbal information was common in Thailand, Malaysia and Uganda. There was commonality across countries in the desire for verbal information with or without WMI (1330; 84.8%); aspects of medicine information wanted most frequently were instructions on medicine use (98.3%), indication (98.2%), name (94.4%) and possible side effects (94.3%); and the importance of providing leaflets with all medicines (87.5%). Fewer than 10% in Uganda would use internet based WMI, compared to between 20% and 55% elsewhere. Conclusion: Preferences for medicine information are similar across countries: verbal information is seen as most desirable, and the most wanted aspects of information are common internationally. Accessibility and understandability are key influences on preferred information sources. In-country regulations and practices should ensure that all medicine users can access the information necessary to maximise safe medicine use.

What happens after an NHS Health Check? A survey and realist review.

Background: The National Health Service Health Check in England aims to provide adults aged 40 to 74 with an assessment of their risk of developing cardiovascular disease and to offer advice to help manage and reduce this risk. The programme is commissioned by local authorities and delivered by a range of providers in different settings, although primarily in general practices. This project focused on variation in the advice, onward referrals and prescriptions offered to attendees following their health check. Objectives: (1) Map recent programme delivery across England via a survey of local authorities; (2) conduct a realist review to enable understanding of how the National Health Service Health Check programme works in different settings, for different groups; (3) provide recommendations to improve delivery. Design: Survey of local authorities and realist review of the literature. Review methods: Realist review is a theory-driven, interpretive approach to evidence synthesis that seeks to explain why, when and for whom outcomes occur. We gathered published research and grey literature (including local evaluation documents and conference materials) via searching and supplementary methods. Extracted data were synthesised using a realist logic of analysis to develop an understanding of important contexts that affect the delivery of National Health Service Health Checks, and underlying mechanisms that produce outcomes related to our project focus. Results: Our findings highlight the variation in National Health Service Health Check delivery models across England. Commissioners, providers and attendees understand the programme's purpose in different ways. When understood primarily as an opportunity to screen for disease, responsibility for delivery and outcomes rests with primary care, and there is an emphasis on volume of checks delivered, gathering essential data and communicating risk. When understood as an opportunity to prompt and support behaviour change, more emphasis is placed on delivery of advice and referrals to 'lifestyle services'. Practical constraints limit what can be delivered within the programme's remit. Public health funding restricts delivery options and links with onward services, while providers may struggle to deliver effective checks when faced with competing priorities. Attendees' responses to the programme are affected by features of delivery models and the constraints they face within their own lives. Limitations: Survey response rate lower than anticipated; review findings limited by the availability and quality of the literature. Conclusions and implications: The purpose and remit of the National Health Service Health Check programme should be clarified, considering prevailing attitudes about its value (especially among providers) and what can be delivered within existing resources. Some variation in delivery is likely to be appropriate to meet local population needs, but lack of clarity for the programme contributes to a 'postcode lottery' effect in the support offered to attendees after a check. Our findings raise important questions about whether the programme itself and services that it may feed into are adequately resourced to achieve positive outcomes for attendees, and whether current delivery models may produce inequitable outcomes. Future work: Policy-makers and commissioners should consider the implications of the findings of this project; future research should address the relative scarcity of studies focused on the end of the National Health Service Health Check pathway. Study registration: PROSPERO registration CRD42020163822. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Services and Delivery Research programme (NIHR129209).

The National Health Service Health Check aims to help people understand their risk of developing some health conditions, including heart disease, stroke, diabetes, kidney disease and dementia. During a check, providers take measurements and ask questions about lifestyle. They calculate a 'risk score' to predict how likely someone is to have a heart attack or stroke in the future. An important next step is for providers to offer advice and support to help people to reduce their risk. This might include referring them to their general practitioner to discuss prescribing medicines, for advice and to offer referrals to other services, such as stop-smoking or weight-management services. We know this activity varies across England. Our project focused on understanding this step: what affects what people are offered after they are told their risk score? We undertook a survey of local authorities, who are responsible for organising and funding the health check. We reviewed the literature on the health check using an approach called 'realist review', to see what it could tell us about how checks are delivered. We found wide variation in what people are offered after being given their risk score. This variation depends on what local authorities and providers think the programme is for, and especially if they think it should be used to find people who have certain health conditions, or if they think it is an opportunity to encourage people to change their lifestyle. Funding and workforce pressures have affected how much time is available during checks for personalised discussion and advice, and limited the services available to help people make lifestyle changes. Based on our findings, our recommendations for policy-makers, local authorities and providers are to make the purpose of the health check clearer and improve links with services that could support people with lifestyle changes.

The NHS Health Check programme: a survey of programme delivery in England before and after the Covid-19 pandemic response.

Background: This study investigated NHS Health Check programme delivery before and after the Covid-19 pandemic response, with a focus on support services and referral methods available to Health Check attendees. The NHS Health Check is an important part of England's Cardiovascular Disease (CVD) prevention programme. Methods: Public health commissioners from all 151 local authorities responsible for commissioning the NHS Health Check programme were surveyed in 2021, using an online questionnaire to capture detail about programme delivery, changes in delivery because of the pandemic response, and monitoring of programme outcomes. Four-point rating scales were used to obtain level of confidence in capacity, accessibility and usage of follow-on support services for Health Check attendees. A typology of programme delivery was developed, and associations between delivery categories and a range of relevant variables were assessed using one-way analysis of variance. Results: Sixty-eight responses were received on behalf of 74 (of 151) local authorities (49%), across all geographical regions. Our findings suggest a basic typology of delivery, though with considerable variation in who is providing the Checks, where and how, and with continued changes prompted by the Covid-19 pandemic. Support for risk management is highly varied with notable gaps in some areas. Local authorities using a model of delivery that includes community venues tended to have a higher number of services to support behaviour change following the Check, and greater confidence in the accessibility and usage of these services. A minority of local authorities gather data on referrals for Health Check attendees, or on outcomes of referrals. Conclusions: The Covid-19 pandemic has prompted continued changes in delivery, which are likely to influence patient experience and outcomes; these need careful evaluation. The programme's delivery and commissioners' intentions to follow through risk communication with appropriate support is challenged by the complexity of the commissioning landscape.

The NHS Health Check programme is for adults in England aged between 40 and 74. It aims to help people to reduce their risk of some major conditions such as heart disease and stroke. The Check involves taking measurements and calculating a 'risk score'. People considered 'at risk' are then advised on how to reduce this. Professionals can refer people to services that will help, like weight management services. Different professionals might provide the Checks in various settings. This depends on choices made by local councils. How and where they are provided, and how well they work, differs across England. Our study helped us learn more about this programme. We focused on what happens after people are told their risk score. There are 151 local councils that make decisions about how to deliver the Health Check programme in their area. We contacted these councils in 2021 to ask them questions in an online questionnaire. These questions were about programme delivery, including during the Covid-19 pandemic. And about whether and how they track programme outcomes. We also asked about the follow-on support services that are available for people. Using this information, we developed broad categories of programme delivery. About half of all local councils responded. Our findings show lots of variation in who is providing the Checks, where and how. The Covid-19 pandemic prompted even more changes. However, we were able to suggest three broad categories of delivery based on our findings. Support for people to manage their disease risk varies, with notable gaps in some areas. Most local councils gather very little information on what happens to people who attend the Health Checks. We need to know more about how different ways of delivering Health Checks affects patient experience and outcomes.

Assessing medication-related burden of community-dwelling individuals with chronic conditions in a small island state.

OBJECTIVES: Medication taking in the management of chronic conditions causes a significant burden on individuals. The aim of this study was to explore the medication-related burden in ambulatory adult patients with chronic conditions in Malta. METHODS: A cross-sectional survey utilising the living with medicines questionnaire V3 (LMQ V3) was conducted in Maltese residents over the age of 18 years, taking at least 1 medication for a chronic condition and recruited through community events. The overall LMQ score, the domain scores and the visual analog scale data were analysed to determine relationships with the demographic factors. RESULTS: A total of 337 responses were analysed revealing a moderate (42.4%) to high medication (36.8%) related burden. The drivers of medication-related burden were primarily: 'side-effects of prescribed medication' (r = -0.843, p < 0.001), 'attitudes/concerns about medicine use' (r = -0.830, p < 0.001) and 'impact/interferences to day-to-day life' (r = -0.820, p < 0.001). Lack of autonomy to vary the dosage regimen resulted in a higher burden (r = -0.260, p < 0.001). Males experienced an overall higher burden (p = 0.046) especially related to practical difficulties (p = 0.04), cost-related burden (p = 0.04) and side-effects of prescribed medication (p = 0.01). CONCLUSION: Medication-related burden is complex and multi-faceted as demonstrated by the findings of this study. Healthcare professionals should seek to identify and address factors causing this burden to improve patient outcomes.

Evaluation of Medicine Information Leaflets for Omeprazole, Safety Knowledge, and Perceptions of Taking the Medication in Thailand.

Purpose: This study aimed to compare package inserts and patient information leaflets for omeprazole in terms of the quality of and satisfaction with the written medicine information, medication safety knowledge, and perceived benefits and risks. Patients and methods: A cross-sectional, comparative study was conducted at a university hospital in Thailand. Outpatients visiting the pharmacy departments prescribed omeprazole were randomly selected to receive either a package insert or a patient information leaflet. Medication safety knowledge was measured using a set of eight questions. The quality of the written medicine information was measured by the Consumer Information Rating Form. Perceived benefits and risks of the medication were rated using a visual analog scale. Linear regression was used to determine factors associated with perceived benefits and risks. Results: Of the 645 patients, 293 agreed to answer the questionnaire. 157 and 136 patients were given patient information leaflets and package inserts, respectively. Most respondents were female (65.6%), over half had a degree (56.2%). Patients reading the patient information leaflets had slightly higher overall safety knowledge scores than those reading the package inserts (5.88 ± 2.25 vs 5.25 ± 1.84, p=0.01). Using the Consumer Information Rating Form, the patient information leaflets were given significantly higher scores compared to the package inserts for comprehensibility (19.34±3.92 vs 17.32±3.52, p<0.001) and design quality (29.25 ± 5.00 vs 23.81 ± 5.16, p<0.001). After reading the leaflets, patients receiving the patient information leaflets had significantly higher satisfaction with the information provided (p=0.003). In contrast, those receiving the package inserts rated the risks of omeprazole higher (p=0.007). Conclusion: Demonstrable differences were found from the patient perspective between a package insert and a patient information leaflet for the same medicine, mostly in favour of patient information leaflets. Medicine safety knowledge after reading PI and PIL was similar. However, receiving package inserts provided higher perceived risks from taking the medicine.

Understanding what happens to attendees after an NHS Health Check: a realist review.

OBJECTIVES: The NHS Health Check offers adults aged 40-74 an assessment of their risk of developing cardiovascular disease. Attendees should be offered appropriate clinical or behavioural interventions to help them to manage or reduce these risks. This project focused on understanding variation in the advice and support offered to Health Check attendees. DESIGN: We conducted a realist review, assembling a diverse body of literature via database searches (MEDLINE, Embase, CINAHL, HMIC, Web of Science) and other search methods, and synthesised data extracted from documents using a realist logic of analysis. Our aim was to develop an understanding of contexts affecting delivery of the NHS Health Check and the underlying mechanisms producing outcomes related to the offer for attendees post-Check. RESULTS: Our findings demonstrate differences in how NHS Health Check commissioners, providers and attendees understand the primary purpose of the programme. A focus on screening for disease can produce an emphasis on high-volume delivery in primary care. When delivery models are organised around behavioural approaches to risk reduction, more emphasis is placed on advice, and referrals to 'lifestyle services'. However, constrained funding and competing priorities for providers limit what can be delivered within the programme's remit. Attendees' experiences and responses to the programme are affected by how the programme is delivered, and by the difficulty of incorporating its outputs into their lives. CONCLUSIONS: The remit of the NHS Health Check should be reviewed with consideration of what can be effectively delivered within existing resources. Variation in delivery may be appropriate to meet local needs, but differences in how the programme's primary purpose is understood contribute to a 'postcode lottery' in post-Check advice and support. Our findings underline existing concerns that the programme may generate inequitable outcomes and raise questions about whether it can deliver positive outcomes for the majority of attendees. TRIAL REGISTRATION NUMBER: PROSPERO CRD42020163822.

Optimising a person-centred approach to stopping medicines in older people with multimorbidity and polypharmacy using the DExTruS framework: a realist review.

BACKGROUND: Tackling problematic polypharmacy requires tailoring the use of medicines to individual circumstances and may involve the process of deprescribing. Deprescribing can cause anxiety and concern for clinicians and patients. Tailoring medication decisions often entails beyond protocol decision-making, a complex process involving emotional and cognitive work for healthcare professionals and patients. We undertook realist review to highlight and understand the interactions between different factors involved in deprescribing and to develop a final programme theory that identifies and explains components of good practice that support a person-centred approach to deprescribing in older patients with multimorbidity and polypharmacy. METHODS: The realist approach involves identifying underlying causal mechanisms and exploring how, and under what conditions they work. We conducted a search of electronic databases which were supplemented by citation checking and consultation with stakeholders to identify other key documents. The review followed the key steps outlined by Pawson et al. and followed the RAMESES standards for realist syntheses. RESULTS: We included 119 included documents from which data were extracted to produce context-mechanism-outcome configurations (CMOCs) and a final programme theory. Our programme theory recognises that deprescribing is a complex intervention influenced by a multitude of factors. The components of our final programme theory include the following: a supportive infrastructure that provides clear guidance around professional responsibilities and that enables multidisciplinary working and continuity of care, consistent access to high-quality relevant patient contextual data, the need to support the creation of a shared explanation and understanding of the meaning and purpose of medicines and a trial and learn approach that provides space for monitoring and continuity. These components may support the development of trust which may be key to managing the uncertainty and in turn optimise outcomes. These components are summarised in the novel DExTruS framework. CONCLUSION: Our findings recognise the complex interpretive practice and decision-making involved in medication management and identify key components needed to support best practice. Our findings have implications for how we design medication review consultations, professional training and for patient records/data management. Our review also highlights the role that trust plays both as a central element of tailored prescribing and a potential outcome of good practice in this area.

Deprescribing medicines in older people living with multimorbidity and polypharmacy: the TAILOR evidence synthesis.

BACKGROUND: Tackling problematic polypharmacy requires tailoring the use of medicines to individual needs and circumstances. This may involve stopping medicines (deprescribing) but patients and clinicians report uncertainty on how best to do this. The TAILOR medication synthesis sought to help understand how best to support deprescribing in older people living with multimorbidity and polypharmacy. OBJECTIVES: We identified two research questions: (1) what evidence exists to support the safe, effective and acceptable stopping of medication in this patient group, and (2) how, for whom and in what contexts can safe and effective tailoring of clinical decisions related to medication use work to produce desired outcomes? We thus described three objectives: (1) to undertake a robust scoping review of the literature on stopping medicines in this group to describe what is being done, where and for what effect; (2) to undertake a realist synthesis review to construct a programme theory that describes 'best practice' and helps explain the heterogeneity of deprescribing approaches; and (3) to translate findings into resources to support tailored prescribing in clinical practice. DATA SOURCES: Experienced information specialists conducted comprehensive searches in MEDLINE, Cumulative Index to Nursing and Allied Health Literature, Web of Science, EMBASE, The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials), Joanna Briggs Institute Database of Systematic Reviews and Implementation Reports, Google (Google Inc., Mountain View, CA, USA) and Google Scholar (targeted searches). REVIEW METHODS: The scoping review followed the five steps described by the Joanna Briggs Institute methodology for conducting a scoping review. The realist review followed the methodological and publication standards for realist reviews described by the Realist And Meta-narrative Evidence Syntheses: Evolving Standards (RAMESES) group. Patient and public involvement partners ensured that our analysis retained a patient-centred focus. RESULTS: Our scoping review identified 9528 abstracts: 8847 were removed at screening and 662 were removed at full-text review. This left 20 studies (published between 2009 and 2020) that examined the effectiveness, safety and acceptability of deprescribing in adults (aged ≥ 50 years) with polypharmacy (five or more prescribed medications) and multimorbidity (two or more conditions). Our analysis revealed that deprescribing under research conditions mapped well to expert guidance on the steps needed for good clinical practice. Our findings offer evidence-informed support to clinicians regarding the safety, clinician acceptability and potential effectiveness of clinical decision-making that demonstrates a structured approach to deprescribing decisions. Our realist review identified 2602 studies with 119 included in the final analysis. The analysis outlined 34 context-mechanism-outcome configurations describing the knowledge work of tailored prescribing under eight headings related to organisational, health-care professional and patient factors, and interventions to improve deprescribing. We conclude that robust tailored deprescribing requires attention to providing an enabling infrastructure, access to data, tailored explanations and trust. LIMITATIONS: Strict application of our definition of multimorbidity during the scoping review may have had an impact on the relevance of the review to clinical practice. The realist review was limited by the data (evidence) available. CONCLUSIONS: Our combined reviews recognise deprescribing as a complex intervention and provide support for the safety of structured approaches to deprescribing, but also highlight the need to integrate patient-centred and contextual factors into best practice models. FUTURE WORK: The TAILOR study has informed new funded research tackling deprescribing in sleep management, and professional education. Further research is being developed to implement tailored prescribing into routine primary care practice. STUDY REGISTRATION: This study is registered as PROSPERO CRD42018107544 and PROSPERO CRD42018104176. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 32. See the NIHR Journals Library website for further project information.

Many patients take multiple medicines, every day, on a long-term basis. Some feel overloaded by their medicines. However, both doctors and patients have told us that they feel anxious about knowing when and how to safely stop medicines. TAILOR aimed to help by providing the information that doctors and patients need to make individual (tailored) decisions about whether or not to stop (deprescribe) medicines. We had two research questions and so used a different research method to answer each. Both methods involved us first finding all the published research looking at deprescribing for older people living with long-term conditions and using five or more medicines a day. Our first (scoping) review produced a map of what we know about deprescribing: how it is done and if it is safe. We found evidence that structured deprescribing can be safe and acceptable to clinicians, but specific effects were very varied and patient views were often not reported. Our team's patient partners continuously reminded us that medicines mean more to individuals than just a medical effect (e.g. a 'tablet for my blood pressure'), meaning that our research needed to describe good person-centred deprescribing. Our second (realist) review focused on this by looking at if and how tailored deprescribing decisions happen. Our results showed that health-care services need to give clinicians the permission and resources they need to work with patients to develop a joint understanding of the value of medicines, to guide decisions about using/changing medicines, and so to build and maintain trust. Our findings remind us that decisions about medicines are personal. We need to remember that any changes in medicines affect not just an individual's disease, but also their understanding of their health and health care. Our work makes recommendations on how future practice and research can be more person centred. We are now working with patients and health-care professionals to share our findings with a wide audience.

Thai Patients' Drug Safety Knowledge and Perceptions Relating to Different Forms of Written Medicine Information: A Comparative Study.

Purpose: The aim of the study was to evaluate the medication safety knowledge, quality of the written medicine information (WMI), and perceptions of taking the medicines in patients receiving package inserts (PIs) in comparison with patient information leaflets (PILs). Methods: A cross-sectional, comparative study was conducted from December 2020 to May 2021 at two university hospitals in Thailand. Outpatients who visited the pharmacy departments and were prescribed one of the three medicines: atorvastatin, celecoxib, or metformin were randomly selected by a permuted block randomization. The medication safety knowledge was measured using a set of validated and closed questions. The quality of the WMI was measured by the Consumer Information Rating Form (CIRF). Satisfaction with information and perceptions of the benefits and risks of medications were rated by the participants using a visual analog scale (0 to 10). Results: Of the 1150 invited patients, 750 completed the questionnaires (65.2%). A higher proportion of respondents with high level of medication safety knowledge was found in those reading the PILs than the PIs (44.5% and 20.8%, respectively). The type of leaflet received was a significant predictor of the high knowledge level (p < 0.001). The mean CIRF scores were significantly higher among those reading the PILs than the PIs (p < 0.001). Patients reading the PILs were also more satisfied with the information and had more positive perceptions of the benefits from taking medicines and intention to adhere than those reading the PIs. Patients' perceptions of risks after reading both leaflets were moderate (median score = 5.0), with the PIL group having slightly more concern about risks than the PI group. Conclusion: The PILs showed superior effectiveness to the PIs in enhancing knowledge about medication safety, providing greater satisfaction with the information, and positive perceptions of benefit and intention to comply with the medications. PILs should be provided more frequently to patients receiving medicines than PIs.

Identifying and managing adverse drug reactions: Qualitative analysis of patient reports to the UK yellow card scheme.

INTRODUCTION: Adverse drug reactions (ADRs) can have significant negative impact on peoples' daily lives, with physical, economic, social and/or psychological effects. Patient reporting of ADRs has been facilitated by pharmacovigilance systems across Europe. However, capturing data on patients' experiences of ADRs has proved challenging. Existing patient reports to the UK Yellow Card Scheme contain free-text comments which could be useful sources of information. OBJECTIVES: To investigate patients' experiences of ADRs and their impact on patients as described in free-text data within patient Yellow Card (YC) reports submitted to the Medicines and Healthcare products Regulatory Agency. METHODS: A qualitative review of narrative texts was conducted on free-text data from 2255 patient YC reports from July to December 2015. RESULTS: Three key narrative themes emerged from analysis of the free-text data in 2255 reports: (1) identification of ADRs, (2) severity and impact of ADRs, and (3) management of ADRs. Temporal associations were the most common method of identification followed by differential diagnoses and confirmation with information sources such as healthcare professionals (HCPs). A combination of explicit and implicit impacts were described: physical, psychological, economic and social effects often persisted and caused serious disruption to many patients' lives. A range of strategies were used to manage ADRs, including consultation with HCPs, stopping/reducing the medicine or taking medicines to alleviate symptoms. CONCLUSION: Free-text data from YC reports has been an underutilised resource to date, but this research has confirmed its potential value to pharmacovigilance and medication safety research.

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.

The Effectiveness and Value of Written Medicine Information Across Asia and Africa: Systematic Review.

Reviews on the role, value, effectiveness and desirable content of written medicine information (WMI) mostly include studies from high-income countries. We reviewed studies from Africa and Asia published between January 2004 and December 2019 to determine (1) the effect of WMI on knowledge and behaviour and (2) whether patients value WMI and their preferences for WMI. We included 16 intervention studies involving almost 3500 participants and 27 surveys of patients/public totalling over 11,000 people. Both the quality of the intervention studies and the reporting quality varied. Surveys were mostly localised, many with inadequate sampling strategies, and hence, were poorly representative of wider populations. However, most included a high proportion of participants with low educational levels. Most of the intervention studies reported significant improvements in knowledge and/or adherence after provision of WMI. Many utilised specially developed WMI in local languages, enhanced by pictograms. Provision of verbal information in addition to WMI showed variable impact. The proportion of people who read WMI, used as an indicator of its value, was reported in 15 surveys, with an overall figure of 74%. The most desirable aspects of WMI reported in 12 studies were indication, side effects, dose/instructions for use, contraindications, precautions and interactions. Nine studies reported local language was desirable. The studies suggest that WMI can improve both knowledge and adherence and is highly valued by people in many countries across Africa and Asia. Mechanisms should be considered by regulatory authorities and manufacturers to facilitate the provision of leaflets in local languages using simple terminology, perhaps enhanced by pictograms.This study is registered with PROSPERO, registration number: CRD42019127001.

NHS Health Check programme: a protocol for a realist review.

INTRODUCTION: The NHS Health Check aims to identify individuals at increased risk of cardiovascular diseases (CVDs) among the adult population in England. The Health Check includes calculation of CVD risk and discussion of pharmacological and lifestyle approaches to manage risk, including referral to lifestyle support services. The programme is commissioned by Local Authorities (LAs) and is delivered by a range of different providers in different settings. There is significant variation in activity, with uptake ranging from 25% to 85% in different areas, and clear evidence of variation in implementation and delivery practice. METHODS AND ANALYSIS: We aim to understand how the NHS Health Check programme works in different settings, for different groups, so that we can recommend improvements to maximise intended outcomes. To do so, we will undertake a realist review and a survey of LA public health teams. Our review will follow Pawson's five iterative stages: (1) locate existing theories, (2) search for evidence, (3) article selection, (4) extract and organise data and (5) synthesise evidence and draw conclusions. Our review will include documents describing local implementation alongside published research studies. We will recruit a stakeholder group (including Public Health England, commissioners and providers of Health Checks, plus members of the public and patients) to advise us throughout. Our survey will be sent to all 152 LAs in England to gather detailed information on programme delivery (including COVID-19-related changes) and available referral services. This will enable us to map delivery across England and relate these data to programme outcomes. ETHICS AND DISSEMINATION: Ethical approval is not required for this review. For the survey, we have received approval from the University of Kent Research Ethics Committee. Our findings will be used to develop recommendations on tailoring, implementation and design strategies to improve delivery of the NHS Health Check in different settings, for different groups. PROSPERO REGISTRATION NUMBER: CRD42020163822.

Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature.

Published reviews of written medicine information (WMI) have mainly drawn on studies published in high-income countries, including very few Asian or African studies. We therefore set out to scope the research literature to determine the extent and type of studies concerning WMI for patients/consumers across these two continents. We sought empirical studies published between January 2004 and December 2019, conducted in any Asian or African country, as defined by the United Nations, in English or with an English abstract. The majority of the 923 papers identified were from high-income countries. We retained 26 papers from Africa and 99 from Asia. Most African studies (n = 20) involved patients in the development of PILs, in the assessment of the effectiveness of PILs or in surveys. In contrast, the highest proportion of Asian studies concerned the content of WMI (n = 42). WMI is desired, but needs to be in local languages, and there needs to be more use made of pre-tested pictograms. Existing WMI frequently does not meet local regulatory requirements, particularly locally manufactured products. A number of studies reported potentially positive impacts of providing WMI on knowledge and medicine use behaviours. Provision of medicine information is essential for safe use of medicines in all countries. Internationally agreed guidelines, incorporating good design principles, are needed to ensure the optimal content and design of WMI. The World Health Organization should support African and Asian regulatory bodies to share best practice in relation to WMI for patients/consumers and to develop and implement pan-continental guidelines that take into account consumer needs and preferences.

Patients' Experiences and Perspectives of Receiving Written Medicine Information About Medicines: A Qualitative Study.

PURPOSE: Written medicine information informs patients about the benefits and risks of medicines and supports their safe and effective use. In Thailand, patient information leaflets (PILs) are not obligatory and therefore not routinely supplied. This study aimed to explore the experiences and information needs of patients, their views on PILs and the likely impact of PILs on their knowledge, perceptions and behaviors towards medicines. These factors are important to establish the value of PILs. METHODS: Semi-structured interviews with outpatients who received simvastatin or atorvastatin were conducted exploring their experiences of receiving medicine information, their views on the utility of and need for PILs, the impact of PILs on their behaviors, and recommendations for how PILs could be improved. All interviews were audio-recorded, transcribed verbatim, and analyzed using a framework approach. RESULTS: Thirty interviews were conducted from which four themes emerged: experience of receiving medicine information, views of package inserts and PILs, impact of PILs on knowledge, perceptions and behaviors, and patients' need for medicine information. Most participants received verbal information from healthcare professionals, as well as written information. Verbal information was perceived as being particularly useful to inform about changes to medicine regimens or the long-term adverse effects of medicines. Patients perceived that the PILs had influenced their knowledge about medicines, and also their behaviors including safety awareness, adherence, and engagement with healthcare professionals. Participants suggested that the information in electronic format could provide an additional resource. Some changes to improve the content and general format of the PIL were identified. CONCLUSION: PILs are perceived as useful by patients and met their information needs, although they were viewed as an adjunct to verbal advice provided by healthcare professionals. PILs influenced patients' medicine taking behaviors and encouraged sharing of information with their physicians.

Cross-Cultural Adaptation and Reliability Testing of Chinese Version of the Living with Medicines Questionnaire in Elderly Patients with Chronic Diseases.

BACKGROUND: The Living with Medicines Questionnaire (LMQ-3) is a reliable, valid instrument used to assess the medication-related burden of patients with chronic disease using long-term medication, but it has not been used in China. PURPOSE: To translate and cross-culturally adapt the LMQ-3 into Chinese and assess its reliability and validity among elderly patients with chronic disease. METHODS: After translation and back-translation, views from an expert group and cognitive interviews with elderly persons using multiple medicines were used to ensure the cultural relevance of the LMQ-3. Then, 412 participants aged 60-92 years were recruited from three communities in Zhengzhou to complete the instrument. Item analysis, internal consistency, content validity, exploratory factor analysis (EFA) and reliability testing were performed. RESULTS: Item analysis identified nine items for possible removal, which were discussed with the originating team. Internal consistency testing confirmed the suitability of removing two of these items, which concurred with the views of the expert group and cognitive interviews. All other items were retained, but four were modified for clarification without changing their meaning, resulting in a 39-item instrument. EFA of this 39-item measure yielded an eight-factor model, similar to the English version. Cronbach's alpha of the Chinese version of LMQ-3 (C-LMQ-3) for elderly patients with chronic diseases was 0.855, and alpha values for the eight domains ranged from 0.822 to 0.932. Test-retest reliability was satisfactory, with ICC values for the eight domain scores ranging from 0.751 to 0.881. CONCLUSION: With only minor modifications compared to the English version, the 39-item C-LMQ-3 is a valid tool, with adequate reliability, which can be used to assess the medication-related burden of long-term use of multiple medicines in elderly patients in China.

Experiences and Views of Medicine Information Among the General Public in Thailand.

PURPOSE: Written and electronic medicine information are important for improving patient knowledge and safe use of medicines. Written medicine information in Thailand is mostly in the form of printed package inserts (PIs), designed for health professionals, with few medicines having patient information leaflets (PILs). The aim of this study was to determine practices, needs and expectations of Thai general public about written and electronic medicine information and attitudes towards PILs. PATIENTS AND METHODS: Cross-sectional survey, using self-completed questionnaires, was distributed directly to members of the general public in a large city, during January to March 2019. It explored experiences of using information, expectations, needs and attitudes, the latter measured using a 10-item scale. Differences between sub-groups were assessed, applying the Bonferroni correction to determine statistical significance. RESULTS: Of the total 851 questionnaires distributed, 550 were returned (64.2%). The majority of respondents (88%) had received PIs, but only a quarter (26.2%) had received PILs. Most respondents (78.5%) had seen medicine information in online form. High educational level and income increased the likelihood of receiving PILs and electronic information. The majority of respondents (88.5%) perceived PILs as useful, but 70% considered they would still need information about medicines from health professionals. Indication, drug name and precautions were the most frequently read information in PIs and perceived as needed in PILs. Three-quarters of respondents would read electronic information if it were available, with more who had received a PIL having previously searched for such information compared to those who had not. All respondents had positive overall attitudes towards PILs. CONCLUSION: Experiences of receiving PILs and electronic medicine information in Thailand are relatively limited. However, the general public considered PILs as a useful source of medicine information. Electronic medicine information was desired and should be developed to be an additional source of information for consumers.