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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 5 th January 2015, retrospectively).

Thai patients do not routinely receive patient information leaflets (PILs) with medicines, so awareness of safety issues is low. This study aimed: i) to develop Thai PILs for NSAIDs and subject these to user-testing, and ii) to assess the potential value of PILs from the patient perspective and effect on patient knowledge. Four PILs for NSAIDs were developed and subjected to multiple rounds of user-testing by the general public. Self-administered questionnaires were distributed to orthopaedic out-patients prescribed one of these NSAIDs, assessing knowledge before and after providing a PIL. The follow-up questionnaire also sought use of and views on the PILs using a visual analogue scale (VAS). 1,240 baseline questionnaires were completed; only 13.5% of patients had good knowledge. 688 patients returned follow-up questionnaires (55.5%), of whom75% had good knowledge. In patients completing both questionnaires, mean knowledge score increased from 6.22±1.40 to 8.42±1.41 (p<0.001). Patients with high educational levels had high baseline scores (OR = 2.728) and showed greatest improvement in knowledge (OR = 5.628). 90% (625) of follow-up respondents indicated they read all information in the PILs. All also agreed that these PILs should distributed to all patients taking NSAIDs. The median VAS score for usefulness was 9.3 (IQR 8.6-10.0). User-testing of PILs was feasible in a Thai population and enabled the development of acceptable and desirable PILs. PILs could improve patients' knowledge about their medicine, particularly among those with higher educational level. User-tested PILS could meet the need for more written medicine information.

ObjectivesThe 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.DesignWe 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.ResultsOur 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.ConclusionsThe 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 numberPROSPERO CRD42020163822

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.

ObjectiveTo translate and validate the consumer information rating form (CIRF) for use in Thai populations.DesignThe development of the CIRF was carried out in two phases: translation process and cognitive interview, and psychometric testing.SettingA university hospital and a tertiary hospital in northeast Thailand.Participants150 outpatients from medicine department: 30 for phase 1 and 120 patients for phase 2 study.MethodsThe 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.ResultsThirty 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).ConclusionThai 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.

IntroductionThe 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 analysisWe 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 disseminationEthical 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 numberCRD42020163822.

Drug Utilization Research (DUR) is an eclectic scientific discipline, integrating descriptive and analytical methods for the quantification, understanding and evaluation of the processes of prescribing, dispensing and consumption of medicines and for the testing of interventions to enhance the quality of these processes. The discipline is closely related and linked mainly to the broader field of pharmacoepidemiology, but also to health outcomes research, pharmacovigilance and health economics. Drug Utilization Research is a unique, practical guide to the assessment and evaluation of prescribing practices and to interventions to improve the use of medicines in populations. Edited by an international expert team from the International Society for Pharmacoepidemiology (ISPE), DUR is the only title to cover both the methodology and applications of drug utilization research and covers areas such as health policy, specific populations, therapeutics and adherence.

From the patient perspective, medicine burden is more than the number of medicines, or the complexity of medicine regimens they need to manage. Relationships between the number of medicines, regimen complexity and patient perception of medicine burden are under-researched. This cross-sectional study measured regimen complexity and determined how this and patient perceived burden are affected by the therapeutic group. Regimen complexity was measured in patients presenting prescriptions to six community pharmacies in South-East England. A sub-sample (166) also completed the Living with Medicines Questionnaire which measures patient perceived burden. The 492 patients were prescribed 2700 medicines (range 1 to 23). Almost half used at least one non-oral formulation. Complexity was correlated strongly with the number of medicines (r = 0.94), number of therapeutic groups (r = 0.84) and number of formulations (r = 0.73). Patients using medicines for skin, eye and respiratory conditions had the highest complexity scores. Increasing the number of medicines, frequency of dosing, number of non-oral formulations and number of different therapeutic groups all increased medicine burden. Although cardiovascular medicines were the most common medicines used by the majority of patients (60%), those for neurological, psychiatric and gastro-intestinal conditions were most strongly associated with high burden. Studies are required to determine medicine burden in different conditions, especially neurological conditions, including chronic pain.

To determine the use and perceived value of different information sources that patients may use to support identification of medicine side effects; to explore associations between coping styles and use of information sources. Side effects from medicines can have considerable negative impact on peoples' daily lives. As a result of an ageing UK population and attendant multi-morbidity, an increasing number of medicines are being prescribed for patients, leading to increased risk of unintended side effects. A cross-sectional survey of patients who use medicine, recruited from community pharmacies. The survey sought views on attributes of various information sources, their predicted and actual use, incorporating a shortened Side Effects Coping Questionnaire (SECope) scale and the abbreviated Miller Behavioural Style Scale (MBSS). Of 935 questionnaires distributed, 230 (25.0%) were returned, 61.3% from females; 44.7% were retired and 84.6% used at least one medicine regularly. 69.6% had experienced a side effect, resulting in 57.5% of these stopping the medicine. Patient information leaflets (PILs) and GPs were both predicted and actually most widely used sources, despite GPs being judged as relatively less accessible and PILs less trustworthy, particularly by regular medicine users. Pharmacists, considered both easy to access and trustworthy, were used by few in practice, while the internet was considered easy to access, but less trustworthy and was also little used. SECope sub-scales for non-adherence and information seeking showed positive associations with stopping a medicine and seeking information from a health professional. More high monitors than low monitors stopped a medicine themselves, but there were no differences in use of information sources. Information seeking following a side effect is a common strategy, potentially predicted by the SECope, but not the MBSS. Limited GP accessibility could contribute to high internet use. Further research could determine how the trustworthiness of PILs can be improved.