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.

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 preliminary validation of an instrument to enable laypersons to assess suspected side effects from medicines.

PURPOSE: Research into causality assessment tools enabling patients to assess suspected adverse drug reactions (ADRs) is limited. Supporting patients with tools could improve their confidence in discussions with health professionals and encourage reporting of suspected ADRs to regulators. This study describes development and preliminary validation of an instrument: Side Effect Patient ASsessment Tool (SE-PAST). METHODS: SE-PAST was developed from survey and interview data involving patients experiencing suspected ADRs. It included 10 statements enabling causality assessment, covering timing, additional information sources, and experiences, with four options: yes/no/don't know/not applicable. Scoring and weighting resulted in four categories of causal association: highly probable, probable, possible, unlikely. Validation involved obtaining feedback from 31 individuals experiencing an ADR. Further validation involved online distribution through patient support groups and comparison of reported symptoms to known ADRs. RESULTS: Validators found SE-PAST easy to read (31), to understand (27), and to complete (29). A total of 294 respondents completed SE-PAST online, with 98% completing eight or more causality assessment statements. Symptoms were categorised as highly probable (46; 16%), probable (80; 62%), possible (44; 15%), and unlikely (21; 7%). A total of 221 respondents identified one suspected medicine, with 95% of these reporting at least one symptom known to be an ADR. Of 227 providing feedback, 139 (61%) found SE-PAST useful, 160 (71%) felt motivated to discuss their experience with a health professional, and 136 (60%) were encouraged to report to the regulator. CONCLUSION: SE-PAST was easily completed and understood by people experiencing suspected ADRs and could be useful in encouraging patient reporting to health professionals and agencies.

Views and experiences of care home staff on managing behaviours that challenge in dementia: a national survey in England.

AIM: To determine the views of care home (CH) staff in relation to experiencing and managing behaviour that challenges (BtC) in dementia and their experiences of training. METHOD: Cross-sectional survey using a self-report questionnaire, distributed to staff employed in a 20% sample of all registered dementia-specialist CHs in England, either by postal or direct distribution. RESULTS: Questionnaires were returned from 352 care staff (25%), representing 5% of all dementia-specialist CHs, half were CH without nursing. Respondents estimated caring for 14,585 residents, 9,361 with dementia and 5,258 with BtC. 30.2% of residents with dementia were estimated as being prescribed a medicine to control BtC. BtC reported as experienced by most respondents were: shouting (96.6%), verbal aggression (96.3%) and physical aggression (95.7%), with physical aggression viewed as most difficult to manage. Top behaviours experienced every shift were: wandering (77.8%), perseveration (68.2%) and restlessness (68.2%). Approaches such as assessing residents, knowing them and treating them as individuals, identifying triggers, having time for them and using an appropriate style of communication, were viewed as key to managing BtC, rather than guideline-specific interventions such as massage, aromatherapy and animal-assisted therapy. Only 38% agreed/strongly agreed medicines were useful to control BtC, which was related to the extent to which they were prescribed. Training was available, but variable in quality with on-line training being least useful and on-the job training most desirable. CONCLUSION: BtC are commonly and frequently experienced by care staff, who consider individual approaches, having time and good communication are key to successful management.

Identifying enablers and barriers to individually tailored prescribing: a survey of healthcare professionals in the UK.

BACKGROUND: Many people now take multiple medications on a long-term basis to manage health conditions. Optimising the benefit of such polypharmacy requires tailoring of medicines use to the needs and circumstances of individuals. However, professionals report barriers to achieving this in practice. In this study, we examined health professionals' perceptions of enablers and barriers to delivering individually tailored prescribing. METHODS: Normalisation Process Theory (NPT) informed an on-line survey of health professionals' views of enablers and barriers to implementation of Individually Tailored Prescribing (ITP) of medicines. Links to the survey were sent out through known professional networks using a convenience/snowball sampling approach. Survey questions sought to identify perceptions of supports/barriers for ITP within the four domains of work described by NPT: sense making, engagement, action and monitoring. Analysis followed the framework approach developed in our previous work. RESULTS: Four hundred and nineteen responses were included in the final analysis (67.3% female, 32.7% male; 52.7% nurse prescribers, 19.8% pharmacists and 21.8% GPs). Almost half (44.9%) were experienced practitioners (16+ years in practice); around one third reported already routinely offering ITP to their patients. GPs were the group least likely to recognise this as consistent usual practice. Findings revealed general support for the principles of ITP but significant variation and inconsistency in understanding and implementation in practice. Our findings reveal four key implications for practice: the need to raise understanding of ITP as a legitimate part of professional practice; to prioritise the work of ITP within the range of individual professional activity; to improve the consistency of training and support for interpretive practice; and to review the impact of formal and informal monitoring processes on practice. CONCLUSION: The findings will inform the ongoing development of our new complex intervention (PRIME Prescribing) to support the individual tailoring of medicines needed to address problematic polypharmacy.

Public confidence in ADR identification and their views on ADRreporting: mixed methods study.

PURPOSE: The value of patients as potential reporters into pharmacovigilance systems is acknowledged worldwide and allowed in Thailand. However, nothing is known about the Thai public's awareness of direct patient reporting facility or their views concerning it. This study aimed to determine confidence among members of the public in identifying suspected adverse drug reactions (ADRs), information sources they use and their views towards direct ADR reporting. METHODS: Mixed methods study consisting of self-administered questionnaires (phase 1) and semi-structured, face-to-face interviews (phase 2) with members of the public recruited in primary care centres, pharmacies and public places during October 2013 to February 2015. All questionnaire respondents reporting an ADR were invited to participate in phase 2. Written informed consent was made before the start of the interview. RESULTS: There were 414 (17.2%) of 2400 questionnaire respondents who had experienced an ADR, almost half (46%) of whom used their own experience to identify ADRs. Having a degree, having a severe ADR and consulting a physician increased respondent confidence in the association between medicine and suspected ADR. The majority (27) of the 30 interviewees indicated general agreement with patient reporting to regulatory authorities. Four main themes emerged covering reasons for reporting ADRs including expectations of health authorities, healthcare professionals and manufacturers, and helping other people. Awareness of direct reporting was low with a desire for a range of reporting methods. CONCLUSION: Results indicate support among the Thai general public of direct ADR reporting. Greater promotion of direct reporting by all healthcare professionals is required.

A cluster randomised control trial to evaluate the effectiveness and cost-effectiveness of the Italian medicines use review (I-MUR) for asthma patients.

BACKGROUND: The economic burden of asthma, which relates to the degree of control, is €5 billion annually in Italy. Pharmacists could help improve asthma control, reducing this burden. This study aimed to evaluate the effectiveness and cost-effectiveness of Medicines Use Reviews provided by community pharmacists in asthma. METHODS: This cluster randomised, multi-centre, controlled trial in adult patients with asthma was conducted in 15 of the 20 regions of Italy between September 2014 and July 2015. After stratification by region, community pharmacists were randomly allocated to group A (trained in and delivered the intervention at baseline) or B (training and delivery 3 months later), using computerised random number generation in blocks of 10. Each recruited up to five patients, with both groups followed for 9 months. The intervention consisted of a systematic, structured face-to-face consultation with a pharmacist, covering asthma symptoms, medicines used, attitude towards medicines and adherence, recording pharmacist-identified pharmaceutical care issues (PCIs). The primary outcome was asthma control, assessed using the Asthma-Control-Test (ACT) score (ACT ≥ 20 represents good control). Secondary outcomes were: number of active ingredients, adherence, cost-effectiveness compared with usual care. Although blinding was not possible for either pharmacists or patients, assessment of outcomes was conducted by researchers blind to group allocation. RESULTS: Numbers of pharmacists and patients enrolled were 283 (A = 136; B = 147) and 1263 (A = 600; B = 663), numbers completing were 201 (A = 97; B = 104) and 816 (A = 400; B = 416), respectively. Patients were similar in age and gender and 56.13% (458/816) had poor/partial asthma control. Pharmacists identified 1256 PCIs (mean 1.54/patient), mostly need for education, monitoring and potentially ineffective therapy. Median ACT score at baseline differed between groups (A = 19, B = 18; p < 0.01). Odds ratio for improved asthma control was 1.76 (95% CI 1.33-2.33) and number needed to treat 10 (95% CI 6-28). Number of active ingredients reduced by 7.9% post-intervention (p < 0.01). Adherence improved by 35.4% 3 months post-intervention and 40.0% at 6 months (p < 0.01). The probability of the intervention being more cost-effective than usual care was 100% at 9 months. CONCLUSIONS: This community pharmacist-based intervention demonstrated both effectiveness and cost-effectiveness. It has since been implemented as the first community pharmacy cognitive service in Italy. TRIAL REGISTRATION: TRN: ISRCTN72438848 (registered 5th January 2015, retrospectively).

Initial development and testing of an instrument for patient self-assessment of adverse drug reactions.

PURPOSE: To develop and conduct preliminary testing of a causality assessment tool for patients, for potential use in encouraging both discussions with clinicians about suspected adverse drug reactions (ADRs) and reporting to authorities. METHODS: Ten causality statements, developed from qualitative studies involving patients, with a scoring system allowing categorization, were embedded in a questionnaire which also included a symptom checklist and additional details about one suspected ADR and medicine, selected for causality assessment. Patients with experiences of suspected ADRs were involved in cognitive interviews (15), piloting (20) and psychometric testing (120). Test-retest reliability, construct validity and criterion-related validity were evaluated, through repeated causality assessment, comparison with a visual analogue scale assessing certainty of causality and comparison with causality assessment using World Health Organization-Uppsala Monitoring Centre (WHO-UMC) criteria, respectively. The study involved outpatients at a university hospital in northeast Thailand. RESULTS: Ninety-eight patients completed causality assessment twice: both causality scores (Spearman rs = 0.715; p < 0.001) and causality classification [percentage of positive agreement (PPA) = 68.4; κ = 0.419; p < 0.001] showed satisfactory reliability. Causality scores were positively correlated with certainty of causality (Spearman rs = 0.556; p < 0.01). There was moderate agreement against WHO-UMC criteria [PPA = 70.4; κ = 0.440; p < 0.001]. Of the 91 completing an evaluation, 88% agreed that the tool should be used routinely, 78% agreed that it gave them useful results and 80% agreed that it was easy to use. CONCLUSIONS: This novel instrument has satisfactory psychometric properties and was acceptable to Thai patients, but it requires further testing. It has potential for use in supporting patients with suspected ADRs to discuss these with health professionals, and perhaps to report directly.

Views and experiences of the NHS Health Check provided by general medical practices: cross-sectional survey in high-risk patients.

BACKGROUND: Since the NHS Health Check programme was initiated in 2009, no survey has sought patients' views of Checks provided by GP practices and few studies have reported views of the wider public. This study sought the views and experiences of patients with potentially high-cardiovascular disease (CVD) risk. METHODS: Cross-sectional postal survey of all the patients with an actual or estimated CVD risk score of at least 20% over 10 years, registered with 16 general practices in Sefton, North West England, with no follow-up. RESULTS: The response rate was 23.4% (644/2958), 67.4% had attended and 73.8% of those not yet invited indicated willingness to attend. Both groups had positive views towards Health Checks, but more non-attenders agreed these should only be performed by doctors. Attenders had better self-reported health and healthy lifestyle than non-attenders. Overall 86.6% of attenders recalled receiving one or more pieces of lifestyle advice and 71.0% claimed to have made at least one lifestyle change; however, perception and understanding of CVD risk appeared limited. CONCLUSION: Both attenders and non-attenders had positive views towards NHS Health Checks in general practice and resultant self-reported lifestyle change in attenders was high. Clearer written information and explanation of personal CVD risk are required.

Randomised evaluation of the Italian medicines use review provided by community pharmacists using asthma as a model (RE I-MUR).

BACKGROUND: The Italian Ministry of Health decided to introduce community professional services in 2010. This trial provides an opportunity to evaluate the outcomes of a new professional pharmacy service: Italian Medicines Use Review (I-MUR) aimed at reducing the severity of asthma and its associated costs. METHODS/DESIGN: This is a cluster randomised controlled trial of the I-MUR service. Data will be collected over time before, during and after pharmacists' intervention. Fifteen Italian regions will be involved and it is aimed to recruit 360 community pharmacists and 1800 patients. Each pharmacist will receive training in medicines use review, recruit five patients, administer the Asthma Control Test and provide the I-MUR service. Pharmacists will be allocated to different groups, one group will be trained in and provide the I-MUR service immediately after completion of the baseline ACT score, the other group will receive training in the I-MUR and provide this service three months later. Group allocation will be random, after stratification by region of Italy. The I-MUR service will involve gathering data following each patient consultation including demographic details, patients regular medications, including those used for asthma, their attitude towards their medications and self-reported adherence to treatments. In addition, pharmacists will identify and record pharmaceutical care issues and any advice given to patients during the I-MUR, or recommendations given to doctors. Pharmacists will upload trial data onto a web platform for analysis. The primary outcome measure is the severity of asthma before, during and after the I-MUR assessed using the Asthma Control Test score. Secondary measures: number of all active ingredients used by patients during and after the I-MUR, number of pharmaceutical care issues identified during the I-MUR, patients' self-reported adherence to asthma medication during and after the I-MUR, healthcare costs based on the severity of asthma, before, during and after the I-MUR service provision. DISCUSSION: This study has been developed because of the need for a new way of working for pharmacists and pharmacies; it is the first trial of any community pharmacy-based pharmaceutical care intervention in Italy. The results will inform future policy and practice in Italian community pharmacy. TRIAL REGISTRATION NUMBER: ISRCTN72438848 .

A qualitative study to explore how patients identify and assess symptoms as adverse drug reactions.

PURPOSE: To explore how Thai patients assess symptoms as adverse drug reactions (ADRs). METHODS: Out-patients at two hospitals in Thailand previously reporting suspected ADRs to statins were purposively selected to cover factors relevant to the accuracy of ADR reports. Semi-structured interviews explored the mechanisms participants used to work out whether their symptoms were related to their statin. All interviews were audio-recorded, transcribed and independently thematically analyzed by two researchers. RESULTS: One hundred interviews were suitable for analysis; 52 were male, age range was 36 to 77 years (mean ± S.D.: 59.83 ± 9.14) and most (92) were taking other medicines in addition to statins. Patient assessment of symptoms as ADRs fell into two major themes: medicine-related factors and external factors. Timing relationships were mentioned most frequently (74), followed by information received (55), seeing similar symptoms in others (7) and diagnosis through blood tests (4). Use of multiple medicines, consideration of the medicine versus diseases, symptoms occurring with more than one medicine or relieved through treatment reduced confidence in ADR attribution. Many participants proposed alternative explanations for symptoms, including old age. Lack of information and knowledge were obstacles to the assessment process. CONCLUSIONS: Patients assessed possible ADRs most often by considering timing relationships. While they also used medicine information, Thai patients received inadequate information to help them assess their symptoms. Patients expressed uncertainty and difficulties in deciding attribution when concomitant medicines and diseases were involved. The findings could support the development of a patient-friendly systematic tool for identifying and assessing possible ADRs.

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.

Views of British community pharmacists on direct patient reporting of adverse drug reactions (ADRs).

PURPOSE: To survey British community pharmacists' views and practices concerning direct patient reporting of ADRs. METHODS: Cross-sectional postal survey of community pharmacists in Britain RESULTS: Of 1096 questionnaires distributed, 297 usable responses were obtained, (27.1%). Respondents' estimates of the frequency of patients reporting a suspected ADR to them had a median of 1.0 per month. Almost a fifth of respondents (19.6%) do not specifically ask patients about ADRs, and 38.7% do not encourage patients to report. Only 18.5% displayed a poster promoting the YC Scheme in their pharmacy, but 57.9% claimed to have patient YCs available. A quarter (24.9%) of respondents considered that ADR reporting should be restricted to health professionals and 14.4% considered that patients were not at all capable of identifying ADRs. CONCLUSIONS: The low response rate and overall results suggest that British community pharmacists may lack interest in and do not promote direct patient reporting. Increased awareness of the benefits and mechanisms of patient reporting may be required to ensure that pharmacists can provide the necessary support to facilitate patient reporting.

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.

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.

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.

Implementing a statin switching programme in primary care: patients' views and experiences.

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT: • Switching of patients' prescribed medicines within a therapeutic class is a common strategy to reduce prescribing costs, and in England a standard methodology has been promoted for switching processes. • Previous work to date suggests many patients are sceptical of generic products and switching may reduce compliance. • Patients' views on switching in general and the processes used have not been widely sought. WHAT THIS STUDY ADDS: • Patients may be less accepting of therapeutic switching programmes than is currently assumed. • Patients lacked understanding of the reason for the switch, despite standard letters and information leaflets being used, and few sought consultations. • Greater explanation of switching, possibly with involvement of community pharmacists, could lead to improved patient understanding and acceptance. INTRODUCTION Estimates suggest £200 million could be saved on prescribing costs in England by implementing medication switches. Few studies have evaluated patients' views or understanding of therapeutic switches. AIM: To obtain patient and pharmacist perspectives on switching from atorvastatin to simvastatin within an English Primary Care Trust (PCT). METHOD: All patients undergoing this switch, in seven self-selected East Lancashire practices, were sent postal questionnaires covering demographics, experiences and views regarding switching, with no reminder. Practice pharmacists implementing switches in these practices were interviewed about processes and their views on these. RESULTS: Pharmacists' switching process involved a standard letter offering a telephone consultation or appointment, plus an information leaflet. They considered most patients accepted switches, with few requesting consultations. Four hundred and ninety-four patients were identified and a response rate of 48.6% (240) obtained. The majority of respondents were happy with the switch (53.7%) and how they were informed (60.1%), with these findings being positively correlated. However over half (52.9%) did not understand the reason for the switch, particularly those with lower educational qualifications. Patients unhappy about switching perceived they had experienced side effects, or only learned of the switch on collecting a prescription or did not recall the consultation offer. Respondents indicated a preference for future switches to involve a face-to-face consultation (59.8%), with two-thirds (65.2%) agreeing that community pharmacists should explain medication switches. CONCLUSION: The standard process used, in line with nationally-designed templates, resulted in many patients being unhappy with or lacking understanding of switching statins, suggesting that improvements may be needed.