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Background: The purpose of this 6-month intervention pilot feasibility randomised trial was to test sending brief messages using mobile phones to promote self-management through taking medication as prescribed to people with type 2 diabetes. This was to inform the design and conduct of a future large-scale United Kingdom-based clinical trial and establish the feasibility of recruitment, the technology used, follow-up, and data collection. Methods: A multicentre individually randomised, controlled parallel group trial in primary care, recruiting adults (≥ 35 years) with type 2 diabetes in England. Consenting participants were randomly allocated to receive short message system text messages up to four times a week, or usual care, for a period of 6 months; messages contained behavioural change techniques targeting medication use. The primary outcome was the rate of recruitment to randomisation of participants to the trial with a planned rate of 22 participants randomised per month. The study also aimed to establish the feasibility of follow-up at 6 months, with an aim of retaining more than 80% of participants. Data, including patient-reported measures, were collected at baseline and the end of the 6-month follow-up period, and a notes review was completed at 24 months. Results: The trial took place between 26 November 2018 and 30 September 2019. In total 209 participants were randomly allocated to intervention (n = 103) or usual care (n = 106). The maximum rate of monthly recruitment to the trial was 60–80 participants per month. In total, 12,734 messages were sent to participants. Of these messages, 47 were identified as having failed to be sent by the service provider. Participants sent 2,864 messages to the automated messaging system. Baseline data from medical records were available for > 90% of participants with the exception of cholesterol (78.9%). At 6 months, a further HbA1c measurement was reported for 67% of participants. In total medical record data were available at 6 months for 207 (99.0%) of participants and completed self-report data were available for 177 (84.7%) of participants. Conclusion: The feasibility of a large-scale randomised evaluation of brief message intervention for people with type 2 diabetes appears to be high using this efficient design. Failure rate of sending messages is low, rapid recruitment was achieved among people with type 2 diabetes, clinical data is available on participants from routine medical records and self-report of economic measures was acceptable. Trial registration: ISCTRN ISRCTN13404264. Registered on 10 October 2018. [ABSTRACT FROM AUTHOR]

Chemical adherence testing is a reliable method to assess adherence to antihypertensive drugs. However, it is expensive and has limited availability in clinical practice. To reduce the number and costs of chemical adherence tests, we aimed to develop and validate a clinical screening tool to identify patients with a low probability of non-adherence in patients with uncontrolled hypertension. In 495 patients with uncontrolled hypertension referred to the University Medical Centre Utrecht (UMCU), the Netherlands, a penalised logistic regression model including seven pre-specified easy-to-measure clinical variables was derived to estimate the probability of non-adherence. Non-adherence was defined as not detecting at least one of the prescribed antihypertensive drugs in plasma or urine. Model performance and test characteristics were evaluated in 240 patients with uncontrolled hypertension referred to the Heartlands Hospital, United Kingdom. Prevalence of non-adherence to antihypertensive drugs was 19% in the UMCU and 44% in the Heartlands Hospital population. After recalibration of the model's intercept, predicted probabilities agreed well with observed frequencies. The c-statistic of the model was 0.63 (95%CI 0.53–0.72). Predicted probability cut-off values of 15%–22.5% prevented testing in 5%–15% of the patients, carrying sensitivities between 97% (64–100) and 90% (80–95), and negative predictive values between 74% (10–99) and 70% (50–85). The combination of seven clinical variables is not sufficient to reliably discriminate adherent from non-adherent individuals to safely reduce the number of chemical adherence tests. This emphasises the complex nature of non-adherence behaviour and thus the need for objective chemical adherence tests in patients with uncontrolled hypertension. [ABSTRACT FROM AUTHOR]

Background: Medication non-adherence is a prevalent health problem in people with type 2 diabetes mellitus (T2DM). Interventions have previously been developed to improve medication adherence, but inconsistent outcomes have been reported. A potential explanation for this inconsistency is a 'one size fits all' approach, with interventions not tailored to the needs and preferences of individuals. Therefore, the aim of this study is to evaluate the effectiveness of a personalised intervention programme aimed at improving adherence to oral antidiabetic and/or antihypertensive medication in people with T2DM.Methods: A parallel-group randomised controlled trial will be conducted in 40-50 community pharmacies in the Netherlands and the United Kingdom (UK). A total of 300 participants will be included and followed up for a period of 6 months. Participants will be people with T2DM identified as non-adherent to oral antidiabetic and/or antihypertensive medication, aged 35-75 years and mobile phone users. The intervention group will receive a personalised intervention programme that is based on one or more of the participants' pre-defined non-adherence profile(s), namely (I) Knowledge and perceptions, (II) Practical problems, (III) Side effects and (IV) Negative mood and beliefs. The intervention comprises of one or more supporting modules, namely (I) Brief messaging, (II) Clinical medication review, (III) Medication schedule, (IV) Reminding messaging, (V) Medication dispensing systems, (VI) Smart messaging, (VII) Referral to general practitioner and (VIII) Unguided web-based Self Help Application for low mood. The control group will receive usual care including access to a publicly available informative diabetes website. The primary study outcome is medication adherence measured with a telephone pill count. Secondary outcomes are systolic blood pressure, HbA1c level, self-reported medication adherence, attitude and beliefs toward medication, satisfaction with diabetes treatment, health status and medical consumption and productivity cost. In addition, a process evaluation will be undertaken to establish the fidelity, reach and the extent to which intervention delivery is normalised in the daily practice of community pharmacy teams.Discussion: The study can lead to a personalised intervention programme that improves medication adherence in people with T2DM that are non-adherent to oral antidiabetic and/or antihypertensive medication.Trial Registration: Dutch Trial Register, Trial NL8747 , registered 02 July, 2020; ISRCTN Registry, ISRCTN36009809 , registered 05 February, 2020. [ABSTRACT FROM AUTHOR]

Objective: Chronic kidney disease (CKD)-associated anaemia has substantial biopsychosocial impacts. This study explores the impact of CKD-associated anaemia and treatment preferences from the patient perspective., Design: Cross-sectional survey., Setting: Anonymised online survey implemented by Ipsos UK on behalf of the National Kidney Federation and GSK from October 2022 to January 2023., Participants: Data were collected from UK adults living with CKD (self-reported)., Primary and Secondary Outcome Measures: Outcome measures were exploratory and not predefined. The cross-sectional survey was designed to explore the biopsychosocial impact of living with anaemia on individuals with CKD; their unmet needs; the treatment strategies typically implemented and the associated barriers/facilitators to adherence; the healthcare professional-patient relationship with regard to anaemia diagnosis and management., Results: Of 101 participants, 90 (89%) were patients with CKD and 11 (11%) were informal carers. 96 (95%) participants reported symptom(s) relevant to their experience of CKD. 88 (87%) participants reported symptom(s) associated with anaemia and 61 (64%) expressed an impact on daily life including 18 (19%) unable to perform daily activities, 13 (14%) unable to go to work and 9 (9%) reporting poor social life/interactions. 85 (84%) participants reported they have received treatment for anaemia: intravenous iron (n=55, 54%), iron tablets (n=29, 29%), erythropoietin-stimulating agents (ESAs) via an autoinjector (n=28, 28%), ESA injections via a syringe (n=24, 24%), ESA injections via a dialysis machine (n=17, 17%), folic acid (n=22, 22%) and blood transfusion (n=17, 17%). Six of seven (86%) participants who received their ESA from a healthcare professional at home preferred injections whereas 13/27 (48%) participants who injected themselves at home preferred oral tablets., Conclusions: There is not a 'one-size-fits-all' approach to the management of CKD-associated anaemia. A personalised approach incorporating the treatment preferences of the individual should be explored when discussing treatment options., Competing Interests: Competing interests: KLH and PR declare no conflicts of interest. JR is an employee of Ipsos and received honoraria for speaking as part of a GSK panel at UK Kidney Week 2023 congress and for an internal seminar delivered to Astellas. CC and MM are employees of and hold shares in GSK. JK was an employee of GSK at the time of the study and is currently an employee of Medice UK Ltd. SP is an employee of Ipsos. JOB received payment for participating in speaker’s bureaus for GSK and CSL Vifor., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives Medication adherence is critical in the successful management of lupus. There is very limited existing literature on reasons why non-adherence is not reported. This study explores the impact of current and previous medical experiences on patient satisfaction, adherence and reporting of non-adherence. Methods Mixed methodology involved thematic analysis of in-depth interviews (n  = 23) to further explore the statistically analysed quantitative survey findings (n  = 186). Results This study identified five themes: (i) physician-patient discordance and a 'hierarchy of evidence' in medication decisions; (ii) the association of adherence with satisfaction with care; (iii) the persisting impact of past adverse medical experiences (AMEs); (iv) the dynamic balance of patient-physician control; and (v) holistic care, beyond a purely medication-based focus. Improving quality of life (43% of participants) and a supportive medical relationship (24%) were the main reasons for adherence. Patient-priorities and self-reported symptoms were perceived as less important to physicians than organ-protection and blood results. Non-reporters of non-adherence, non-adherers and those with past AMEs (e.g. psychosomatic misdiagnoses) had statistically significant lower satisfaction with care. The importance of listening to patients was a key component of every theme, and associated with patient satisfaction and adherence. The mean rating for rheumatologist's listening skills was 2.88 for non-adherers compared with 3.53 for other participants (mean difference 0.65, P = 0.003). Conclusion Patients would like more weight and discussion given to self-reported symptoms and quality of life in medication decisions. Greater understanding and interventions are required to alleviate the persisting impact of past AMEs on some patients' wellbeing, behaviour and current medical relationships. [ABSTRACT FROM AUTHOR]

Objectives: To examine if informing people in free‐at‐the‐point‐of‐use medical systems of the financial value of medicines, and priming them with the fact that the medication is funded by taxation, influences people's perceived value and efficacy of the medicines, feelings of burdensomeness and guilt, and intended adherence. Design: An experiment was implemented to examine the impact of medication labelling featuring the presence (vs. absence) of the phrase 'funded by UK the taxpayer' and pricing information (absent vs. £20 vs. £200) on outcome measures. Methods: A total of 257 UK participants (age: M = 29.10 years, SD = 9.15; 89 males, 167 females, one undisclosed) who were currently taking medication were recruited from an online participant pool (prolific academic). Participants viewed an image of a medication with the manipulated price and taxation message on the label. They then completed a number of measures to gauge perceived value and efficacy of the medicines, feelings of burdensomeness and guilt, and intended adherence. Results: Findings point to both positive and negative consequences of such labelling of medication, with the taxpayer label increasing perceptions of value but also increasing feelings of guilt. The price labels demonstrated a positive effect on perceived value and intended adherence. Conclusions: Discussion of results is centred on potential policy implications, applied recommendations, and future directions for study. [ABSTRACT FROM AUTHOR]

Aim: To assess the willingness of people with type 2 diabetes (T2D) to engage in healthy eating, physical activity and medication taking, and explore associated patient factors., Methods: Online survey among recently diagnosed T2D patients recruited in the Netherlands and the United Kingdom (UK). Patient factors included general factors and behaviour-specific beliefs. Logistic regression analyses and explorative comparisons were conducted., Results: Overall, 48% of 67 patients were willing to engage in all three management options, whereas 6% were not willing to follow any of them. 73% were willing to manage T2D with healthy eating, 73% with physical activity, and 72% with medication. Country of recruitment was significantly associated with willingness for healthy eating, with higher willingness among Dutch participants. Beliefs surrounding capability, opportunity, and motivation were significantly associated with willingness to engage in physical activity and medication taking. Many beliefs were similar regardless of willingness but those willing to engage in physical activity perceived less barriers and those willing to take medication had more positive and less negative outcome beliefs than those not willing., Conclusions: Willingness to engage in all management options was limited among recently diagnosed patients, and partly associated with behaviour-specific patient beliefs., Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to disclose., (Copyright © 2024. Published by Elsevier Ltd.)

Purpose: Medicines regulatory authorities advise that patient information leaflets (PILs) should provide specific advice on what actions to take if one or more doses are missed. We aimed to assess the content in this regard, of PILs and Summaries of Product Characteristics (SmPCs) of prescription only medicines (POMs) marketed in the UK. Methods: PILs and SmPCs were accessed via the electronic Medicines Compendium. The following terms were used in the advanced search facility: miss(ed), omit(ted), adhere(d), delay(ed), forgot, forget, lapse. Identified documents were screened for instructions on missed doses which were categorised according to level of specificity, and cross-referenced to the National Patient Safety Agency (NPSA) grading of risk of harm from omitted and delayed medicines. Any supporting clinical or pharmacological evidence was identified from SmPCs. Results: Two thousand two hundred eighty-four documents were identified from 7248 PILs and SmPCs relating to 1501 POMs. Seven hundred eighty-three (52%) POMs had SmPCs or PILs with no instructions on missed doses; 487 POMs (32%) included non-specific advice (e.g. "take as soon as possible"); 138 (9%) provided specific instructions; and 93 (6%) referred patients to seek medical advice. SmPCs for only 13/138 (9%) of those which included specific instructions provided any supporting clinical or pharmacological evidence. Instructions were absent for several medicines where the NPSA assessed that dose omissions may result in significant risk of harm. Conclusions: Advice on missed doses is generally inadequate. Pharmaceutical companies and regulatory authorities should produce clear and concise instructions on what patients should do if they miss doses, with supporting evidence where necessary. [ABSTRACT FROM AUTHOR]

Tailored interventions delivered via text and voice messages can improve adherence to multiple medications. However, no such intervention has been developed in the UK primary-care setting. We conducted focus groups with 12 patients with hypertension, type 2 diabetes, or both conditions, presumed to be non-adherent and recruited from deprived neighborhoods, to assess the acceptability and inform the development of an intervention to provide ongoing support for adherence, as an adjunct to primary-care consultations. Patients recommended ways to improve the tailored content and delivery of the intervention; like highly interactive messages to report both medication taking and determinants of medication adherence. [ABSTRACT FROM AUTHOR]

Introduction: Many older people live with both multiple long-term conditions and frailty; thus, they manage complex medicines regimens and are at heightened risk of the consequences of medicines errors. Research to enhance how people manage medicines has focused on adherence to regimens rather than on the wider skills necessary to safely manage medicines, and the older population living with frailty and managing multiple medicines at home has been under-explored. This study, therefore, examines in depth how older people with mild to moderate frailty manage their polypharmacy regimens at home., Methods: Between June 2021 and February 2022, 32 patients aged 65 years or older with mild or moderate frailty and taking five or more medicines were recruited from 10 medical practices in the North of England, United Kingdom, and the CARE 75+ research cohort. Semi-structured interviews were conducted face to face, by telephone or online. The interviews were recorded, transcribed verbatim and analysed using reflexive thematic analysis., Findings: Five themes were developed: (1) Managing many medicines is a skilled job I didn't apply for; (2) Medicines keep me going, but what happened to my life?; (3) Managing medicines in an unclear system; (4) Support with medicines that makes my work easier; and (5) My medicines are familiar to me-there is nothing else I need (or want) to know. While navigating fragmented care, patients were expected to fit new medicines routines into their lives and keep on top of their medicines supply. Sometimes, they felt let down by a system that created new obstacles instead of supporting their complex daily work., Conclusion: Frail older patients, who are at heightened risk of the impact of medicines errors, are expected to perform complex work to safely self-manage multiple medicines at home. Such a workload needs to be acknowledged, and more needs to be done to prepare people in order to avoid harm from medicines., Patient and Public Involvement: An older person managing multiple medicines at home was a core member of the research team. An advisory group of older patients and family members advised the study and was involved in the first stages of data analysis. This influenced how data were coded and themes shaped., (© 2024 The Authors. Health Expectations published by John Wiley & Sons Ltd.)

The gastrointestinal (GI) tract has a number of functions—ingestion, digestion, absorption and elimination. When the GI tract is working normally, it is efficient. However, this can change when disease, such as inflammatory bowel disease (IBD) occurs. IBD is a long-term relapsing and remitting autoimmune disease; it incorporates ulcerative colitis (UC). In UC, part or all the mucosa lining the rectum and colon becomes inflamed and ulcerated. UC that affects the rectum only is called proctitis. Effective treatment is essential. It is better to target the rectal mucosa directly in proctitis, using topical rectal medications in enemas or suppositories, as these have fewer side-effects and resolve symptoms more quickly than systemic drugs. However, patients may not feel clear about aspects of their IBD care and can find it difficult to initiate and comply with treatment and maintenance regimens. Nurses need to educate and support them to achieve optimal therapeutic outcomes in both the immediate and long terms. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to investigate the provision of community pharmacy services to children and young people with a focus on advanced services such as medicines use review. Perceptions and experiences of community pharmacists, pharmacy staff, young people and their parents or carers on the provision of such services were also explored. Methods: Four different cross-sectional, self-administered questionnaires were distributed in parallel to pharmacists, pharmacy staff members, children and young people and parents in the United Kingdom. Results: An outline of pharmacist's current involvement with children and young people was provided by 92 pharmacists. A different group of 38 community pharmacists and 40 non-pharmacist members of pharmacy staff from a total of 46 pharmacies provided information and views on the conduct of Medicines use review with children and young people. Experiences of advanced pharmacy service provision were collected from 51 children and young people and 18 parents. Most pharmacists offered public health advice to children and young people (73/92; 79.3%) and even more (83/92; 90.2%) reported that they often interacted with children and young people with long-term condition. Despite their high levels of interaction, and a majority opinion that medicines use reviews could benefit children (35/38; 92.1%), the number of pharmacies reporting to have conducted medicines use reviews with children was low (5/41). Pharmacists perceived the main barriers to recruitment as consent (17/29; 58.6%), guideline ambiguity (14/29; 48.3%) and training (13/29; 44.8%). A considerable proportion pharmacists (12/29; 41.4%) and other personnel (14/33; 42.4%) working in community pharmacies were unaware that children were potentially eligible for medicines use reviews. Only 29.4% of the 51 children and young people participants had received advice about their long-term condition from a pharmacist and the majority (46/51; 90.2%) had not taken part in an advanced service focused on adherence. Conclusions: While general engagement with children and young people appears high from the pharmacist's perspective, advice specific to children and young people with long-term conditions and the provision of advanced services in this group remains a challenge. [ABSTRACT FROM AUTHOR]

Objective: This study presents the development and validation of MIS-A (Medication Intake Survey-Asthma), a new self-report instrument measuring key adherence properties during long-term asthma treatment. Design: Within a longitudinal asthma cohort study in France and the United Kingdom, adult patients and caregivers of children responded to computer-assisted telephone interviews. Main outcome measures: Scores for distinct adherence properties (taking adherence, correct dosing, therapeutic coverage, drug holidays, overuse) and composite measures were computed for several time intervals. We examined distributions, longitudinal variation, associations between adherence scores and concordance with adherence calculated from medication prescribing or dispensing records. Results: Nine hundred and two participants reported on adherence to 4481 medications on 4140 occasions. About 59.47 and 70.36% revealed < 100% taking adherence in the last week and month; 42.76% had a drug holiday of > 1 week in the last 4 months. Adherence varied within patients during the follow-up (intra-class correlation = . 41-.71). Correlations between adherence scores were moderate to strong (p = .51-.85, p = .001), except medication overuse (p = .04-.19, p =.05). Four-month taking adherence was associated with dispensing adherence, but not with prescribing adherence (p = .33, p < .001; and .12, p = .26). Conclusion: MIS-A is a promising, easy-to-use self-report tool that can capture accurately different adherence properties over a long time period. [ABSTRACT FROM AUTHOR]

Introduction: Women with breast cancer who do not adhere to adjuvant endocrine therapy (AET) have increased risks of mortality and recurrence. There are multiple barriers to AET adherence, including medication side-effects, beliefs about medication, memory and psychological distress. We developed four intervention components, each targeting a different barrier. This pilot trial is part of the preparation phase of the Multiphase Optimisation Strategy, and aims to establish key trial parameters, establish intervention component adherence, establish availability and feasibility of outcome and process data, estimate variability in planned outcome measures and estimate cost of developing and delivering each intervention component., Methods and Analysis: The four intervention components are as follows: short message service text reminders (target: memory); a written information leaflet (target: medication beliefs); a guided self-help Acceptance and Commitment Therapy programme (target: psychological flexibility to reduce distress) and a self-management website (target: side-effect management). To evaluate the feasibility of recruitment, acceptability of the intervention components and the availability of outcome data, we will conduct a multisite, exploratory pilot trial using a 2 4-1 fractional factorial design, with a nested process evaluation. We will randomise 80 women with early-stage breast cancer who have been prescribed AET to one of eight experimental conditions. This will determine the combination of intervention components they receive, ranging from zero to four, with all conditions receiving usual care. Key outcomes of interest include medication adherence and quality of life. Progression to the optimisation phase will be based on predefined criteria for consent rates, patient adherence to intervention components and availability of medication adherence data., Ethics and Dissemination: The study was reviewed by the Wales Research Authority Research Ethics Committee 3 (21/WA/0322). Written informed consent will be obtained from all patients before randomisation. The results of this trial will be disseminated in a peer-reviewed journal., Trial Registration Number: ISRTCN10487576., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Objective:To explore patients’ and physicians’ experiences of atrial fibrillation (AF) consultations and oral anticoagulation decision-making. Design:Multi-perspective interpretative phenomenological analyses. Methods:Participants included small homogeneous subgroups: AF patients who accepted (n = 4), refused (n = 4) or discontinued (n = 3) warfarin, and four physician subgroups (n = 4 each group): consultant cardiologists, consultant general physicians, general practitioners and cardiology registrars. Semi-structured interviews were conducted. Transcripts were analysed using multi-perspective interpretative phenomenological analysis (IPA) analyses to attend to individuals within subgroups and making comparisons within and between groups. Results:Three themes represented patients’ experiences:Positioning within the physician–patient dyad,Health–life balance, andDrug myths and fear of stroke. Physicians’ accounts generated three themes:Mechanised metaphors and probabilities,Navigating toward the‘right’decisionandNegotiating systemic factors. Conclusions:This multi-perspective IPA design facilitated an understanding of the diagnostic consultation and treatment decision-making which foregrounded patients’ and physicians’ experiences. We drew on Habermas’ theory of communicative action to recommend broadening the content within consultations and shifting the focus to patients’ life contexts. Interventions including specialist multidisciplinary teams, flexible management in primary care and multifaceted interventions for information provision may enable the creation of an environment that supports genuine patient involvement and participatory decision-making. [ABSTRACT FROM PUBLISHER]

Background: Cystic Fibrosis (CF) management requires complex treatment regimens but adherence to treatment is poor and has negative health implications. There are various methods of measuring adherence, but little is known regarding the extent of adherence measurement in CF centres throughout the UK and Ireland.Objective: To determine the adherence monitoring practices in CF centres throughout the UK and Ireland, and to establish CF pharmacists' views on these practices.Setting: UK and Ireland Cystic Fibrosis Pharmacists' Group's annual meeting (2014).Methods: A questionnaire was designed, piloted and distributed to pharmacists attending the UK and Ireland Cystic Fibrosis Pharmacists' Group's annual meeting (2014). The main outcome measures were the methods of inhaled/nebulised antibiotic supply and the methods used to measure treatment adherence in CF centres. The questionnaire also ascertained the demographic information of participating pharmacists. Closed question responses were analysed using descriptive statistics. Open questions were analysed using content analysis.Results: Twenty-one respondents (84 % response) were included in the analysis and were mostly from English centres (66.7 %). Detailed records of patients receiving their inhaled/nebulised antibiotics were lacking. Adherence was most commonly described to be measured at 'every clinic visit' (28.6 %) and 'occasionally' (28.6 %). Patient self-reported adherence was the most commonly used method of measuring adherence in practice (90.5 %). The availability of electronic adherence monitoring in CF centres did not guarantee its use. Pharmacists attributed an equal professional responsibility for adherence monitoring in CF to Consultants, Nurses and Pharmacists. Seventy-six percent of pharmacists felt that the current adherence monitoring practices within their own unit were inadequate and associated with the absence of sufficient specialist CF pharmacist involvement. Many suggested that greater specialist pharmacist involvement could facilitate improved adherence monitoring.Conclusion: Current adherence knowledge is largely based on self-report. Further work is required to establish the most appropriate method of adherence monitoring in CF centres, to improve the recording of adherence and to understand the impact of increased specialist pharmacist involvement on that adherence. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Clinical trial data suggest that patients who have received bisphosphonates continue to benefit from them after discontinuation. However, data from real-world clinical practice are inconclusive. We assessed the impact of persistence and discontinuation on health resource utilization ( HRU) and fracture rate in women who were prescribed oral bisphosphonates. Method The study used data from the UK Clinical Practice Research Datalink. Women aged 50 years or older with a first prescription of oral bisphosphonate therapy between January 2000 and December 2007 were included. Multivariate modelling compared rate ratios for fracture and HRU between patients who had discontinued medication (shorter persistence group) and patients who took their medication for longer (longer persistence group). The interactions of elapsed time (measured as 6-month intervals) with HRU and with fracture rate for all patients within paired groups were also assessed. Results Overall, 36 320 patients were included. Pairwise comparisons showed that HRU and fracture rates were lower in longer persistence groups than in shorter persistence groups. Analysis by 6-month interval showed that, across all patients in persistence group pairs, HRU significantly increased for each additional 6 months elapsed; trends towards increased risk of fracture were also seen. Conclusion In contrast to results from clinical trials, in this patient population the protective effect of oral bisphosphonates after discontinuation was not sufficient to reduce HRU and fracture rates to the levels that would be seen if patients had continued on therapy. Reducing the rate of treatment discontinuation may decrease the burden that osteoporosis places on both patients and health care systems. [ABSTRACT FROM AUTHOR]

Objectives. To investigate levels of self-reported adherence to biologic treatment and establish the contribution of demographic, physical and psychological factors to biologic medication adherence in an RA cohort. Methods. Adalimumab-treated patients were recruited through the British Society for Rheumatology Biologics Register for RA between May 2007 and April 2009. Demographic and baseline psychological measures including illness and medication beliefs were collected. Disease activity (28-item DAS), physical function (HAQ) and quality of life (36-item Short Form Health Survey) were also measured at baseline and at 6, 12 and 18 months. Adherence was assessed at each follow-up using the patient self-completed Compliance Questionnaire for Rheumatology (CQR). Multilevel mixed effects modelling analysis was performed to investigate predictors of adherence. Results. Of the 329 Adalimumab-treated patients included, low adherence (CQR score <65) was reported in 23%, with 41% reporting low adherence at at least one time point. After controlling for age and disease duration, factors independently predictive of increased adherence were increased belief in medication necessity, with baseline effect diminishing over time [β coefficient 1.68 (S.E. 0.19), P = 0.0001], lower medication concerns [0.50 (0.15), P = 0.001], with this effect remaining throughout follow-up, increased professional or family member support [0.81 (0.32), P = 0.01], strong views of illness being chronic [0.32 (0.14), P = 0.025] and increased treatment control [0.41 (0.19), P = 0.032]. Conclusion. Wider recognition of the importance of psychological factors, particularly medication beliefs, in driving medication adherence could have substantial clinical and health economic benefits in RA. The psychological factors we have identified are putative targets for strategies to improve adherence in RA. [ABSTRACT FROM AUTHOR]

Background: Poor adherence to prescribed medication has major consequences. Managing multiple long-term conditions often involves polypharmacy, potentially increasing complexity and the possibility of poor adherence. As a result of the globally recognised problems in supporting adherence to medication, some researchers have proposed the use of reminder charts. The main aim of the research was to explore the need for and perceptions around the 'Universal Medication Schedule' (UMS). Looking at ways in which pharmacists and General Practitioners (GPs) could use the UMS in NHS settings. Methods: Semi-structured interviews were carried out with 10 GPs, 10 community pharmacists and 15 patients. Patients were aged 65 years and over, had multiple long-term conditions and were prescribed at least 5 medications. Interviews were recorded and transcribed and thematic analysis was conducted, using a framework approach to manage the data. Results: Attitudes towards the UMS were mixed with stakeholders seeing benefits and limitations to the chart. Practitioners proposed a number of existing services where they thought the UMS could easily be integrated but there was evidence of role conflict with GPs feeling it may be best placed with pharmacists and vice versa. The potential for the UMS to be used as a tool to aid communication between the different services involved in a patient's care was a key theme. Conclusions: The UMS chart provides consolidated medicines information that might help to improve patients' knowledge and health literacy, which may or may not improve adherence but could help patients in making informed decisions about their treatment. One of the key benefits of using the UMS in practice is that it could be introduced across services. In this way it may aid in medicines reconciliation between healthcare settings to ensure continuity of message, improve patient experience and create more joined up working between services. Further research is needed to test implementation in different services and to assess outcomes on patient understanding and adherence. [ABSTRACT FROM AUTHOR]

Methods: Using information from electronic health records in Germany and the United Kingdom (UK) in a common data model, we followed adults with ≥2 low-dose aspirin prescriptions (75-100 mg) during 2007-2018 for up to 10 years. Included individuals had no low-dose aspirin prescriptions in the year before the follow-up started (date of first low-dose aspirin prescription) and ≥12 months' observation. Adherence was determined using the medication possession ratio (MPR), and persistence was defined as continuous treatment disregarding gaps between prescriptions of <60 days; analyses were undertaken according to indication (primary/secondary CVD prevention)., Results: We identified 144,717 low-dose aspirin users from Germany and 190,907 from the UK. Among patients with 5-10 years' follow-up, median adherence among secondary CVD prevention users was 60% in Germany and 75% in the UK. Among primary prevention users, median adherence was 50% for both countries. Persistence among secondary CVD prevention users was 58.3% at 2 years, 47.0% at 5 years, 35.2% at 10 years (Germany), and 67.5% at 2 years, 58.0% at 5 years, and 46.8% at 10 years (UK). Among primary CVD prevention users, persistence was 52.8% at 2 years, 41.6% at 5 years, 32.1% at 10 years (Germany), 56.3% at 2 years, 45.4% at 5 years, and 33.8% at 10 years (UK)., Conclusions: Long-term adherence and persistence to low-dose aspirin are suboptimal; efforts for improvement could translate into a lower CVD burden in the general population., Competing Interests: PV and MS-G are employees of Bayer AG, the funder of the study. BR received consultancy fees from Bayer at the time of the study. HMS is an employee of IQVIA, which received funding from Bayer to perform the data analysis., (Copyright © 2022 Pareen Vora et al.)

Background The Aston Medication Adherence Study was designed to examine non-adherence to prescribed medicines within an inner-city population using general practice (GP) prescribing data. Objective To examine non-adherence patterns to prescribed oral medications within three chronic disease states and to compare differences in adherence levels between various patient groups to assist the routine identification of low adherence amongst patients within the Heart of Birmingham teaching Primary Care Trust (HoBtPCT). Setting Patients within the area covered by HoBtPCT (England) prescribed medication for dyslipidaemia, type-2 diabetes and hypothyroidism, between 2000 and 2010 inclusively. HoBtPCT's population was disproportionately young, with seventy per cent of residents from Black and Minority Ethnic groups. Method Systematic computational analysis of all medication issue data from 76 GP surgeries dichotomised patients into two groups (adherent and non-adherent) for each pharmacotherapeutic agent within the treatment groups. Dichotomised groupings were further analysed by recorded patient demographics to identify predictors of lower adherence levels. Results were compared to an analysis of a self-report measure of adherence [using the Modified Morisky Scale (MMAS-8)] and clinical value data (cholesterol values) from GP surgery records. Main outcome Adherence levels for different patient demographics, for patients within specific longterm treatment groups. Results Analysis within all three groups showed that for patients with the following characteristics, adherence levels were statistically lower than for others; patients: younger than 60 years of age; whose religion is coded as 'Islam'; whose ethnicity is coded as one of the Asian groupings or as 'Caribbean', 'Other Black' and 'African'; whose primary language is coded as 'Urdu' or 'Bengali'; and whose postcodes indicate that they live within the most socioeconomically deprived areas of HoBtPCT. Statistically significant correlations between adherence status and results from the selfreport measure of adherence and of clinical value data analysis were found. Conclusion Using data from GP prescribing systems, a computerised tool to calculate individual adherence levels for oral pharmacotherapy for the treatment of diabetes, dyslipidaemia and hypothyroidism has been developed. The tool has been used to establish nonadherence levels within the three treatment groups and the demographic characteristics indicative of lower adherence levels, which in turn will enable the targeting of interventional support within HoBtPCT. [ABSTRACT FROM AUTHOR]

Objective: There have been few recent studies reporting on the outcomes for users of psychiatric rehabilitation services. This group has complex, longer-term mental health problems. We aimed to investigate 5-year outcomes for this group and identify factors associated with outcome. Method: Clinical outcome data on 141 users of a mental health rehabilitation service in inner London, UK, surveyed in 2005, were collected retrospectively 5 years later. Positive outcome was defined for those who were inpatients in 2005 as achieving and sustaining community discharge, and for those who were community patients, as progressing to and sustaining a less supported community placement. Negative outcome was defined as remaining in the same placement, moving to more supported placement or having a psychiatric admission. Results: Over 5 years, 17 (12 %) people died, 50 (40 %) had a positive outcome, 33 (27 %) remained in a placement with a similar level of support and 41 (38 %) moved to a more supported placement and/or had a psychiatric admission. Thirteen (10 %) people moved to independent accommodation and sustained their tenancy successfully. Those with a record of non-adherence with medication during the 5 years were more likely to have a negative outcome (OR 8.60, 95 % CI 3.41 to 21.70). Conclusion: Adherence to medication is an important factor in facilitating successful community discharge for people with complex mental health problems who require psychiatric rehabilitation. [ABSTRACT FROM AUTHOR]

Objectives: The prescribing of oral chemotherapy agents previously available only in the intravenous formulation, such as capecitabine, has afforded many benefits including reduced administration costs and improved patient acceptability. However, it has introduced the new challenge of ensuring patient adherence to therapy. It is therefore necessary to quantify adherence, and with a view to improving services, explore factors that may impact on medication taking behavior.Methods: Patients with a diagnosis of breast or colorectal cancer and prescribed capecitabine were recruited from a UK teaching hospital. Data regarding self-reported adherence, beliefs about medicines, side effects, and satisfaction with information received about capecitabine were recorded.Results: Non-adherence was reported by 23.3% of the 43 participants. Capecitabine therapy was perceived necessary by 97.6%, but almost one-third of participants had strong concerns. Side effects were reported by 80% of participants, with Palmar–Plantar erythrodysesthesia and fatigue most troubling participants. Complete satisfaction with information received was reported by 65% of participants; however, dissatisfaction about how to tell if capecitabine is working and the proposed duration of therapy was expressed by 42.9% and 37.3% of participants, respectively.Conclusions: Adherence to capecitabine is high with a strong conviction that the therapy is necessary. However, concerns were expressed regarding the experience of side effects. Patients have unmet information needs regarding the processes involved with monitoring capecitabine efficacy and determination of therapy duration. Healthcare professionals may therefore wish to consider a greater focus on involving patients in the monitoring of their care with respect to efficacy and planned treatment schedules. [ABSTRACT FROM PUBLISHER]

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Overview of: Tomlinson J, Cheong VL, Fylan B, et al Successful care transitions for older people: a systematic review and meta-analysis of the effects of interventions that support medication continuity. Age and Ageing 2020;49:558-69., (© BMJ Publishing Group Limited 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To describe patient characteristics, treatment patterns and healthcare utilization (HCU) of non-active users of maintenance asthma medications in the United Kingdom. Methods: Retrospective, cohort analysis of patients with asthma, aged ≥ 6 years who were non-active users of maintenance therapy (no prescription for inhaled corticosteroids (ICS), combined ICS/long-acting beta agonists (ICS/LABA) or 'other' bronchodilatory therapies in last 12 months) were identified in the Clinical Practice Research Datalink (2012-2015) and followed-up for 2 years after a new prescription for an asthma maintenance medication (index date). Patient characteristics, most common maintenance treatment sequences and HCU were described. Results: 55,293 patients were identified (ICS: 46,297, ICS/LABA: 8,367; Other: 629). Mean age was 37 years and 56% were female. During follow-up, the most common treatment sequences across groups implied intermittent use, comprising periods of maintenance therapy interspersed with maintenance-free periods. During year 1 and year 2 of follow-up, the proportion of patients prescribed OCS was 19% and 13%, prescribed ≥ 4 short-acting bronchodilators (SABD) was 24% and 19%, having ≥ 3 asthma-related primary care consultations/year was 59% and 36% and experiencing ≥ 1 exacerbation/year was 15% and 11%, respectively. Conclusions: In previously non-active users of asthma maintenance medication subsequently commenced on maintenance therapy, intermittent use was common during the 2-year follow-up despite the potential need for regular use as evidenced by patient HCU and SABD usage patterns. This highlights the need for regular patient assessment and education on medication adherence to ensure appropriateness of prescribing to maintain asthma control.

The PAM intervention is a behavioural intervention to support adherence to anti-hypertensive medications and therefore to lower blood pressure. This feasibility trial recruited 101 nonadherent patients (54% male, mean age 65.8 years) with hypertension and high blood pressure from nine general practices in the UK. The trial had 15.5% uptake and 7.9% attrition rate. Patients were randomly allocated to two groups: the intervention group (n = 61) received the PAM intervention as an adjunct to usual care; the control group (n = 40) received usual care only. At 3 months, biochemically validated medication adherence was improved by 20% (95% CI 3-36%) in the intervention than control, and systolic blood pressure was reduced by 9.16 mmHg (95% CI 5.69-12.64) in intervention than control. Improvements in medication adherence and reductions in blood pressure suggested potential intervention effectiveness. For a subsample of patients, improvements in medication adherence and reductions in full lipid profile (cholesterol 1.39 mmol/mol 95% CI 0.64-1.40) and in glycated haemoglobin (3.08 mmol/mol, 95% CI 0.42-5.73) favoured the intervention. A larger trial will obtain rigorous evidence about the potential clinical effectiveness and cost-effectiveness of the intervention.Trial registration Trial date of first registration 28/01/2019. ISRCTN74504989. https://doi.org/10.1186/ISRCTN74504989 .

Background: There is strong evidence that anti-platelet therapy, ACE inhibitors, beta-blockers and statins are cost-effective in reducing subsequent cardiovascular disease (CVD) events in patients with atherosclerotic cardiovascular disease (ACVD). In some settings, only a low proportion of people have access to these medications, and even lower adhere to them. The current study explored and presents data on the causes of poor adherence to orthodox medication and motivations for alternative therapies in patients with established atherosclerotic cardiovascular disease (ACVD)., Methods: The study was conducted among city-dwelling adults with ACVD in Accra - Ghana's capital city. Eighteen interviews were conducted with patients with established ACVD. A follow-up focus group discussion was conducted with some of them. The protocol was approved by two ethics review committees based in Ghana and in the United Kingdom. All participants were interviewed after informed consent. Analysis was done with the Nvivo qualitative data analysis software., Results: We identified motivations for use of alternatives to orthodox therapies. These cover the five dimensions of adherence: social and economic, health-care system, condition-related, therapy-related, and patient-related dimensions. Perceived inability of an orthodox medication to provide immediate benefit is an important motivator for use of alternative forms of medication., Conclusions: A multiplicity of factors precipitate non-adherence to orthodox therapies. Perceived efficacy and easy access to local alternative therapies such as herbal and faith-based therapies are important motivators., (© 2021 The Authors. Health Expectations published by John Wiley & Sons Ltd.)

Introduction: Reducing smoking during pregnancy is a public health priority. Nicotine replacement therapy (NRT) is offered routinely to pregnant women who smoke in the United Kingdom. However, evidence of treatment efficacy in this population is weak, most likely due to poor adherence. Guided by the Necessity-Concerns Framework, we conducted a qualitative study to better understand pregnant women's perceived needs and concerns regarding NRT use, with consideration of combination NRT., Methods: Semi-structured interviews were conducted by telephone with 18 pregnant or recently pregnant women in England and Wales, purposively sampled for different NRT-related experiences. Participants were recruited online via Facebook adverts and through a Stop Smoking Service. A hybrid approach of deductive and inductive thematic coding was used for analysis., Results: Findings were organized around three themes: 1) the role of motivation to stop smoking; 2) necessity beliefs about using NRT; and 3) concerns about NRT. Some women reported fluctuating motivation for stopping smoking which undermined their NRT use. Others used NRT to cut down the number of cigarettes they smoked. Reasons for low NRT necessity beliefs included a preference for quitting unassisted, low or unrealistic expectations of efficacy, and overconfidence in achieving cessation (necessity testing). Concerns included safety, particularly around increased nicotine exposure with combination NRT, addictiveness, side effects, and capability to use., Conclusion: Pregnant women have multiple necessity beliefs and concerns that influence their use of NRT. Targeting these, alongside increasing and maintaining motivation to quit smoking, will likely help optimize NRT use in pregnancy and improve quit rates., (© 2020 The Authors. British Journal of Health Psychologogy published by John Wiley & Sons Ltd on behalf of British Psychological Society.)

Introduction: The ORBITA trial of percutaneous coronary intervention (PCI) versus a placebo procedure for patients with stable angina was conducted across six sites in the United Kingdom via home monitoring and telephone consultations. Patients underwent detailed assessment of medication adherence which allowed us to measure the efficacy of the implementation of the optimization protocol and interpretation of the main trial endpoints., Methods: Prescribing data were collected throughout the trial. Self-reported adherence was assessed, and urine samples collected at pre-randomization and at follow-up for direct assessment of adherence using high-performance liquid chromatography with tandem mass spectrometry (HPLC MS/MS)., Results: Self-reported adherence was >96% for all drugs in both treatment groups at both stages. The percentage of samples in which drug was detected at pre-randomization and at follow-up in the PCI versus placebo groups respectively was: clopidogrel, 96% versus 90% and 98% versus 94%; atorvastatin, 95% versus 92% and 92% versus 91%; perindopril, 95% versus 97% and 85% versus 100%; bisoprolol, 98% versus 99% and 96% versus 97%; amlodipine, 99% versus 99% and 94% versus 96%; nicorandil, 98% versus 96% and 94% versus 92%; ivabradine, 100% versus 100% and 100% versus 100%; and ranolazine, 100% versus 100% and 100% versus 100%., Conclusions: Adherence levels were high throughout the study when quantified by self-reporting methods and similarly high proportions of drug were detected by urinary assay. The results indicate successful implementation of the optimization protocol delivered by telephone, an approach that could serve as a model for treatment of chronic conditions, particularly as consultations are increasingly conducted online., (© 2021 The Authors. Pharmacology Research & Perspectives published by John Wiley & Sons Ltd, British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics.)

Aims: Six Delta is a six-dimensional independent platform for outcome-based pricing/contracting. The six dimensions have been described separately: (δ1) cost-effectiveness analysis and cost-utility analysis-based pricing; (δ2) willingness-to-pay-based pricing; (δ3) reference-based pricing; (δ4) safety-based pricing; (δ5) risk of efficacy failure-based pricing; and (δ6) adherence-based pricing. The final step is to integrate the various dimension-specific pricing estimates into a composite estimate termed the All-Dimensional Price (ADP). We describe the methodology for this integration and present a proof-of-concept application to the treatment of non-small cell lung cancer (NSCLC) with EGFR mutation with osimertinib., Materials and Methods: For better accuracy in estimating the ADP, we used the prices generated from the six dimensions at scenario levels, not at the dimension-specific price (DSP) level. We pooled the price estimates and performed Monte Carlo Simulations (MCS) for the price scenarios generated by the six dimensions. We used the results of the proof-of-concept exercise involving osimertinib in NSCLC with EGFR mutation to estimate the ADP in two hypothetical contracts: 1-year (2019-2020) and 2-year contract (2019-2021)., Results: The average of the 30-day prescription estimates from the six dimensions averaged $10,819 (SD=$8,486) for the 1-year contract and $10,730 (SD=$8,500) for the 2-year contract. MCS yielded for the 1-year contract an ADP of $10,959 (or -25.02% the 2018 WAC price) and an ADP for the 2-year contract was $10,788 (or -26.19% the 2018 WAC price)., Conclusions: We demonstrated that the integration of the prices from the six dimensions of the Six Delta platform and market conditions is feasible and yields multidimensional prices estimates to support outcome-based pricing/contracting.

Background: The efficacy of a highly tailored digital intervention to support medication adherence and feasibility to support clinical effectiveness as an adjunct to the primary care setting has not been evaluated., Objective: This trial aimed to assess the behavioral efficacy of a highly tailored digital intervention to support medication adherence and to evaluate the feasibility of its clinical effectiveness, in patients with either or both hypertension and type 2 diabetes. We also examined quality of life and mechanisms of behavior change. Intervention fidelity, engagement, and satisfaction were also explored., Methods: This was a multicenter, individually randomized controlled trial of 2 parallel groups: an intervention group that received a highly tailored text message and interactive voice response intervention for 12 weeks, and a control group that received usual care. Medication adherence was measured using self-reports and assessor-blinded practice records of a repeat prescription. Systolic blood pressure and glucose levels were assessed by nurses blinded to group allocation during practice visits at 3 months follow-up. Questionnaires obtained data to assess intervention mechanisms of action and satisfaction and digital log files captured data to evaluate fidelity and engagement., Results: A total of 135 nonadherent patients (62/135, 46% female; 122/135, 90.3%; aged above 50 years) were randomly allocated in the intervention (n=79) or in the control group (n=56); of whom 13% (18/135) were lost at follow-up. Medication adherence was significantly improved in the intervention group compared with the control group (t 116 =2.27; P=.02, 2-tailed). Systolic blood pressure was 0.6 mmHg (95% CI -7.423 to 6.301), and hemoglobin A 1c was 4.5 mmol/mol (95% CI -13.099 to 4.710) lower in the intervention group compared with the control group. Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; P=.04), but not in the control group (beta=.00, SE 1.35; P=.37). The intervention had 100% fidelity, a median of 12 days of engagement, and 76% overall satisfaction., Conclusions: Our trial is the first that has been conducted in the United Kingdom and showed that among nonadherent patients with either or both hypertension and type 2 diabetes, a highly tailored digital intervention was effective at improving treatment adherence and feasible to obtain clinically meaningful outcomes. Changes in intentional and nonintentional nonadherence predicted the improvements in medication adherence. The intervention had high fidelity, engagement, and satisfaction. Future research using a rigorous design is needed to evaluate the clinical effectiveness and cost-effectiveness of the intervention in primary care., Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 10668149; http://www.controlled-trials.com/ISRCTN10668149., (©Aikaterini Kassavou, Venus Mirzaei, James Brimicombe, Simon Edwards, Efthalia Massou, A Toby Prevost, Simon Griffin, Stephen Sutton. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 19.05.2020.)

Background: Most people who are dying want to be cared for at home, but only half of them achieve this. The likelihood of a home death often depends on the availability of able and willing lay carers. When people who are dying are unable to take oral medication, injectable medication is used. When top-up medication is required, a health-care professional travels to the dying person's home, which may delay symptom relief. The administration of subcutaneous medication by lay carers, although not widespread UK practice, has proven to be key in achieving better symptom control for those dying at home in other countries., Objectives: To determine if carer administration of as-needed subcutaneous medication for common breakthrough symptoms in people dying at home is feasible and acceptable in the UK, and if it would be feasible to test this intervention in a future definitive randomised controlled trial., Design: We conducted a two-arm, parallel-group, individually randomised, open pilot trial of the intervention versus usual care, with a 1 : 1 allocation ratio, using convergent mixed methods., Setting: Home-based care without 24/7 paid care provision, in three UK sites., Participants: Participants were dyads of adult patients and carers: patients in the last weeks of their life who wished to die at home and lay carers who were willing to be trained to give subcutaneous medication. Strict risk assessment criteria needed to be met before approach, including known history of substance abuse or carer ability to be trained to competency., Intervention: Intervention-group carers received training by local nurses using a manualised training package., Main Outcome Measures: Quantitative data were collected at baseline and 6-8 weeks post bereavement and via carer diaries. Interviews with carers and health-care professionals explored attitudes to, experiences of and preferences for giving subcutaneous medication and experience of trial processes. The main outcomes of interest were feasibility, acceptability, recruitment rates, attrition and selection of the most appropriate outcome measures., Results: In total, 40 out of 101 eligible dyads were recruited (39.6%), which met the feasibility criterion of recruiting > 30% of eligible dyads. The expected recruitment target (≈50 dyads) was not reached, as fewer than expected participants were identified. Although the overall retention rate was 55% (22/40), this was substantially unbalanced [30% (6/20) usual care and 80% (16/20) intervention]. The feasibility criterion of > 40% retention was, therefore, considered not met. A total of 12 carers (intervention, n  = 10; usual care, n  = 2) and 20 health-care professionals were interviewed. The intervention was considered acceptable, feasible and safe in the small study population. The context of the feasibility study was not ideal, as district nurses were seriously overstretched and unfamiliar with research methods. A disparity in readiness to consider the intervention was demonstrated between carers and health-care professionals. Findings showed that there were methodological and ethics issues pertaining to researching last days of life care., Conclusion: The success of a future definitive trial is uncertain because of equivocal results in the progression criteria, particularly poor recruitment overall and a low retention rate in the usual-care group. Future work regarding the intervention should include understanding the context of UK areas where this has been adopted, ascertaining wider public views and exploring health-care professional views on burden and risk in the NHS context. There should be consideration of the need for national policy and of the most appropriate quantitative outcome measures to use. This will help to ascertain if there are unanswered questions to be studied in a trial., Trial Registration: Current Controlled Trials ISRCTN11211024., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 24, No. 25. See the NIHR Journals Library website for further project information., Competing Interests: Anthony Byrne reports grants from Marie Curie (London, UK), Health and Care Research Wales, the End of Life Board for Wales and the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme outside the submitted work; he is also a member of the End of Life Board for Wales, which is responsible to the Welsh Government for developing and implementing strategy for end-of-life care in Wales. Bee Wee reports that she is National Clinical Director for End of Life Care, Chairperson of the National Institute for Health and Care Excellence Quality Standards Advisory Committee and has a NIHR-funded grant outside the submitted work. She has also received royalties for a book published by Oxford University Press (Oxford, UK). Dyfrig Hughes reports that he was a member of the HTA Programme Pharmaceuticals Panel (2008–12) and member of the HTA Programme Clinical Evaluation and Trials Board (2010–16). Marlise Poolman was a member of the HTA Prioritisation Committee: Integrated Community Health and Social Care (A) from 2013 to 2019. Zoe Hoare reports that she is an associate member of NIHR Health Services and Delivery Research board. Clare Wilkinson reports that she was chairperson of the HTA Commissioning Panel – Primary Care, Community, Preventive Interventions (2013–18) and a member of the HTA Rapid and Add-0n Trials Board (2012–13).

Background: The prevalence of type 2 diabetes (T2D) is greater in South Asian populations and health outcomes are poorer compared with other ethnic groups. British South Asians are up to six times more likely to have T2D than the general population, to develop the condition at a younger age, and to experience diabetes-related complications. Interventions to support people in managing their condition can potentially reduce debilitating complications. Evidence to support the use of digital devices in T2D management, including mobile phones, has shown positive impacts on glycemic control. There is increasing recognition that health interventions that are culturally adapted to the needs of specific groups are more likely to be relevant and acceptable, but evidence to support the effectiveness of adapted interventions is limited and inconclusive., Objective: This formative study aimed to explore the perceptions and views of British South Asian patients with T2D on mobile health SMS text messaging to support medication adherence, aimed at the general UK population., Methods: Eight exploratory focus groups were conducted in Leicester, the United Kingdom, between September 2017 and March 2018. A diverse sample of 67 adults took part., Results: British South Asian people with T2D who use digital devices, including mobile phones, felt that short messages to support medication adherence would be acceptable and relevant, but they also wanted messages that would support other aspects of self-management too. Participants were particularly interested in content that met their information needs, including information about South Asian foods, commonly used herbs and spices, natural and herbal approaches used in the United Kingdom and in South Asia, and religious fasting. Short messages delivered in English were perceived to be acceptable, often because family members could translate for those unable to read or understand the messages. Suggestions to support patients unable to understand short messages in English included having them available in different formats, and disseminated in face-to-face groups for those who did not use digital devices., Conclusions: Exploring the views of British South Asian patients about SMS text messaging aimed at the general UK population is important in maximizing the potential of such an intervention. For such a digital system to meet the needs of UK South Asian populations, it may also have to include culturally relevant messages sent to those who opt to receive them. It is equally important to consider how to disseminate message content to patients who do not use digital devices to help reduce health inequalities., (©Suman Prinjha, Ignacio Ricci-Cabello, Nikki Newhouse, Andrew Farmer. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 20.04.2020.)

Competing Interests: Supplementary file Competing interests: The BMJ has judged that there are no disqualifying financial ties to commercial companies. The authors declare the following other interests: none Further details of The BMJ policy on financial interests are here: https://www.bmj.com/about-bmj/resources-authors/forms-policies-and-checklists/declaration-competing-interests

Gaining full benefits from osteoporosis medications requires long-term treatment. Investigating the real-world persistence of women receiving osteoporosis medications in the UK, we found that most patients stop treatment within a year. To prevent osteoporotic fragility fractures, long-term treatment persistence must be improved., Introduction: Persistence with osteoporosis therapies has historically been poor. To treat this chronic and progressive disease, it is essential that patients receive the full benefit of these medications. We estimated persistence and compliance with osteoporosis therapies in a large sample of postmenopausal women in the UK., Methods: Data were obtained from the Clinical Practice Research Datalink for all women aged 50 years and over or women with early menopause, who received at least one prescription in primary care for any licensed osteoporosis therapy between January 1, 2010 and December 31, 2015. Persistence and compliance at 24 months (primary objective) and at 5 years (exploratory objective) were estimated in three patient cohorts: "All Patients," "Naïve Patients," and "Drug-Specific.", Results: The All Patients cohort included 72,256 women. Persistence with any therapy was 56.1%, 43.6%, 36.4%, and 31.0% at 6, 12, 18, and 24 months, respectively, and 23.2% and 13.1% at 3 years and 5 years, respectively. Patients were generally more persistent and compliant if evaluated from their first exposure to osteoporosis therapy (Naïve Patients cohort). In the drug-specific analysis, 64% of patients receiving denosumab (administered subcutaneously every 6 months) were persistent at 24 months compared with 28% and 23% of those taking oral bisphosphonates and intravenous bisphosphonates, respectively., Conclusions: Only about one in three patients who received osteoporosis therapy continued to be on treatment after 2 years. There is a need to improve persistence with osteoporosis therapy, especially for high-risk patients.

Background: Accurate centre-level medication adherence measurement allows identification of highly performing CF centres, drives shared learning and informs quality improvement. Self-reported adherence is unreliable but data-logging nebulisers can capture objective data. However, adherence levels in current literature are limited by the use of agreed prescriptions and convenience sampling. In this single-centre retrospective study, we quantified the differences in centre-level adherence with different methods of calculating adherence (unadjusted vs normative adherence) and different data sampling frames (convenience sampling vs including difficult to obtain data)., Methods: Adherence data were objectively captured using I-neb® from 2013-2016 in Sheffield Adult CF Centre. Adults on non data-logging devices, on ivacaftor or with previous lung transplantation were excluded. Adherence was calculated based on agreed regimen ('unadjusted adherence') or minimum required regimen ('normative adherence'). I-nebs® not brought to clinic were downloaded during home visits. Adults not on any inhaled therapy but with chronic Pseudomonas aeruginosa infection were included by counting their adherence as "0"., Results: Of the 131 included adults, 126 provided I-neb® data. Calculating unadjusted adherence from I-nebs® brought to clinics resulted in the highest centre-level adherence (median 41.8% in 2013). Median adherence reduced after sequentially accounting for minimum required regimen (40.0% in 2013), I-nebs® not brought to clinics (32.9% in 2013) and adults not on any inhaled therapy (31.0% in 2013)., Conclusions: Different approaches of calculating adherence produced different adherence levels. Adherence levels based only on agreed regimen among adults who readily brought their nebulisers to clinics can over-estimate the effective adherence of CF centres., Competing Interests: Declaration of Competing Interest None declared., (Copyright © 2019. Published by Elsevier B.V.)

Background: Despite simpler regimens than vitamin K antagonists (VKAs) for stroke prevention in atrial fibrillation (AF), adherence (taking drugs as prescribed) and persistence (continuation of drugs) to direct oral anticoagulants are suboptimal, yet understudied in electronic health records (EHRs)., Objective: We investigated (1) time trends at individual and system levels, and (2) the risk factors for and associations between adherence and persistence., Methods: In UK primary care EHR (The Health Information Network 2011-2016), we investigated adherence and persistence at 1 year for oral anticoagulants (OACs) in adults with incident AF. Baseline characteristics were analysed by OAC and adherence/persistence status. Risk factors for non-adherence and non-persistence were assessed using Cox and logistic regression. Patterns of adherence and persistence were analysed., Results: Among 36 652 individuals with incident AF, cardiovascular comorbidities (median CHA 2 DS 2 VASc[Congestive heart failure, Hypertension, Age≥75 years, Diabetes mellitus, Stroke, Vascular disease, Age 65-74 years, Sex category] 3) and polypharmacy (median number of drugs 6) were common. Adherence was 55.2% (95% CI 54.6 to 55.7), 51.2% (95% CI 50.6 to 51.8), 66.5% (95% CI 63.7 to 69.2), 63.1% (95% CI 61.8 to 64.4) and 64.7% (95% CI 63.2 to 66.1) for all OACs, VKA, dabigatran, rivaroxaban and apixaban. One-year persistence was 65.9% (95% CI 65.4 to 66.5), 63.4% (95% CI 62.8 to 64.0), 61.4% (95% CI 58.3 to 64.2), 72.3% (95% CI 70.9 to 73.7) and 78.7% (95% CI 77.1 to 80.1) for all OACs, VKA, dabigatran, rivaroxaban and apixaban. Risk of non-adherence and non-persistence increased over time at individual and system levels. Increasing comorbidity was associated with reduced risk of non-adherence and non-persistence across all OACs. Overall rates of 'primary non-adherence' (stopping after first prescription), 'non-adherent non-persistence' and 'persistent adherence' were 3.5%, 26.5% and 40.2%, differing across OACs., Conclusions: Adherence and persistence to OACs are low at 1 year with heterogeneity across drugs and over time at individual and system levels. Better understanding of contributory factors will inform interventions to improve adherence and persistence across OACs in individuals and populations., Competing Interests: Competing interests: AB reports personal fees from AstraZeneca, Boehringer Ingelheim, Pfizer and Novo Nordisk. SA reports personal fees from Bayer, Boehringer Ingelheim, Pfizer/BMS and Daiichi Sankyo. RJS reports grants and personal fees from Boehringer Ingelheim; grants and personal fees from Daiichi Sankyo; grants, personal fees and non-financial support from Medtronic; grants, personal fees and non-financial support from Boston Scientific; grants, personal fees and non-financial support from Abbott Medical; and grants, personal fees and non-financial support from Biosense Webster. WDS reports grants and personal fees from Boehringer Ingelheim; grants and personal fees from Daiichi Sankyo; grants, personal fees and non-financial support from Medtronic; grants, personal fees and non-financial support from Boston Scientific; grants, personal fees and non-financial support from Abbott Medical; and grants, personal fees and non-financial support from Biosense Webster. The remaining authors have no competing interests., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

In the large community-based SCOOP trial, systematic fracture risk screening using FRAX ® led to greater use of AOM and greater adherence, in women at high fracture risk, compared with usual care., Introduction: In the SCreening of Older wOmen for Prevention of fracture (SCOOP) trial, we investigated the effect of the screening intervention on subsequent long-term self-reported adherence to anti-osteoporosis medications (AOM)., Methods: SCOOP was a primary care-based UK multicentre trial of screening for fracture risk. A total of 12,483 women (70-85 years) were randomised to either usual NHS care, or assessment using the FRAX ® tool ± dual-energy X-ray absorptiometry (DXA), with medication recommended for those found to be at high risk of hip fracture. Self-reported AOM use was obtained by postal questionnaires at 6, 12, 24, 36, 48 and 60 months. Analysis was limited to those who initiated AOM during follow-up. Logistic regression was used to explore baseline determinants of adherence (good ≥ 80%; poor < 80%)., Results: The mean (SD) age of participants was 75.6 (4.2) years, with 6233 randomised to screening and 6250 to the control group. Of those participants identified at high fracture risk in the screening group, 38.2% of those on treatment at 6 months were still treated at 60 months, whereas the corresponding figure for the control group was 21.6%. Older age was associated with poorer adherence (OR per year increase in age 0.96 [95% CI 0.93, 0.99], p = 0.01), whereas history of parental hip fracture was associated with greater rate adherence (OR 1.67 [95% CI 1.23, 2.26], p < 0.01)., Conclusions: Systematic fracture risk screening using FRAX ® leads to greater use of AOM and greater adherence, in women at high fracture risk, compared with usual care.

Inhaled corticosteroids (ICS) adherence is important for asthma management. Current evidence on the impact of ICS adherence on outcomes is mostly based on correlational analyses of between-person data. Although it is widely acknowledged that asthma outcomes fluctuate over time, evidence on predictors of within-person change is scarce. We aimed to quantify these fluctuations and the longitudinal relationships between ICS adherence and outcomes at both between- and within-person levels.A prospective cohort of persistent asthma patients in France and the UK (n=847, age 6-40 years) provided 3756 reports over up to 2 years via computer-assisted telephone interviews and text messages on ICS adherence, asthma control, reliever medication use and exacerbations. We examined adherence-outcome relationships via longitudinal models, controlling for confounders, including severity.Considerable within-person variability was found for exacerbations (91%), asthma control (59%) and reliever use (52%); 431 (11.5%) reports signalled exacerbations and 2046 (54.5%) poor control. At between-person level, patients with higher average adherence were more likely to report asthma control (OR 1.25, 95% CI 1.06-1.47), but not asthma exacerbations (OR 0.99, 95% CI 0.87-1.12) or lower reliever use (b -0.0004, 95% CI -0.089-0.088). At within-person level, higher-than-usual adherence was associated with higher concomitant reliever use (b 0.092, 95% CI 0.053-0.131) and lower subsequent reliever use (b -0.047, 95% CI -0.005- -0.088); it was unrelated to asthma control (OR 0.93, 95% CI 0.84-1.02) or exacerbations (OR 1.04, 95% CI 0.94-1.16).Patients maintaining high ICS adherence over time have better asthma control. Temporarily increasing ICS adherence tends to be simultaneous to higher reliever use and reduces reliever use later on. Causes of within-person variation in outcomes require more investigation., Competing Interests: Conflict of interest: A.L. Dima reports grants from European Commission (European Community's 7th Framework (FP7/2007-2013) under grant agreement number 282593 and H2020 programme (MSCA-IF) under grant agreement number 706028), during the conduct of the study; grants and non-financial support from Respiratory Effectiveness Group, outside the submitted work. Conflict of interest: E. van Ganse reports grants from European Commission (European Community's 7th Framework (FP7/2007-2013) under grant agreement number 282593), during the conduct of the study; grants and personal fees from ALK ABELLO, Bayer, BMS, GlaxoSmithKline and Merck Sharp and Dohme, personal fees from PELyon, outside the submitted work. Conflict of interest: G. Stadler has nothing to disclose. Conflict of interest: M. de Bruin reports grants from European Commission (European Community's 7th Framework (FP7/2007-2013) under grant agreement number 282593), during the conduct of the study., (Copyright ©ERS 2019.)

Introduction: Compared with the rest of the UK and Western Europe, England has high rates of the infectious disease tuberculosis (TB). TB is curable, although treatment is for at least 6 months and longer when disease is drug resistant. If patients miss too many doses (non-adherence), they may transmit infection for longer and the infecting bacteria may develop resistance to the standard drugs used for treatment. Non-adherence may therefore risk both their health and that of others. Within England, certain population groups are thought to be at higher risk of non-adherence, but the factors contributing to this have been insufficiently determined, as have the best interventions to promote adherence. The objective of this study was to develop a manualised package of interventions for use as part of routine care within National Health Services to address the social and cultural factors that lead to poor adherence to treatment for TB disease., Methods and Analysis: This study uses a mixed-methods approach, with six study components. These are (1) scoping reviews of the literature; (2) qualitative research with patients, carers and healthcare professionals; (3) development of the intervention; (4) a pilot randomised controlled trial of the manualised intervention; (5) a process evaluation to examine clinical utility; and (6) a cost analysis., Ethics and Dissemination: This study received ethics approval on 24 December 2018 from Camberwell St. Giles Ethics Committee, UK (REC reference 18/LO/1818). Findings will be published and disseminated through peer-reviewed publications and conference presentations, published in an end of study report to our funder (the National Institute for Health Research, UK) and presented to key stakeholders., Trial Registration Number: ISRCTN95243114 SECONDARY IDENTIFYING NUMBERS: University College London/University College London Hospitals Joint Research Office 17/0726.National Institute for Health Research, UK 16/88/06., Competing Interests: Competing interests: IA, MD, HK, KK, ML, MM, EP, AS and FW have no competing interests to declare. RH is supported by the National Institute for Health Research (NIHR, Collaboration for Leadership in Applied Health Research and Care, North Thames at Bart's Health NHS Trust and Asthma UK (AUKCAR). Speaker engagements with honoraria with the following companies: Abbvie, Amgen, Astellas, AstraZeneca, Biogen, Erasmus, Idec, Gilead Sciences, GlaxoSmithKline, Janssen, Merck Sharp Dohme, Novartis, Pfizer, Roche, Shire Pharmaceuticals and TEVA. RH is founding director of a UCL-Business spin-out company (Spoonful of Sugar Ltd) providing consultancy on treatment engagement and patient support programmes to healthcare policy makers, providers and industry. HRS reports grants from Medical Research Council, UK, and grants from NIHR, UK, during the conduct of the study; others from Korean CDC and Johnson and Johnson (makers of Bedaquiline), others from Latvian Society Against Tuberculosis (funding through Otsuka and Johnson and Johnson), outside the submitted work. CNJC reports personal fees from Public Health England outside the submitted work., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Background: There is a lack of data on the impact of COPD on individuals, their illness, behavior and attitude to the disease., Method: 500 UK patients with a primary care diagnosis of COPD responded to an online survey., Results: 61.2% of respondents were female and 85.8% were between 50 and 80 years old. Two-thirds (67.8%) of respondents did not smoke at the time of the survey. Almost half of those surveyed (46.2%, n=231) used three inhalers, and 31% (n=155) agreed or strongly agreed with the statement "I feel that my treatment is not adequately controlling my condition", while 39.4% (n=197) disagreed or strongly disagreed. 48.8% (n=244) agreed their COPD was well managed. Over half the sample (56.8%, n=284) said they never forgot to use their inhaler as prescribed. Checks on inhaler use by doctors or nurses were reported as every six months/twice a year by 24.4% (n=122) and once a year by 38.8% (n=194). However, 17.2% (n=86) said their technique had never been checked, and at their last annual review, a third (33.2%, n=166) did not receive inhaler technique advice. Exacerbations were reported to affect an average of 7.4 days a year. They led to time in hospital, time off work and significantly affected quality of life. Patients reported that their COPD affected all aspects of their daily lives to a greater or lesser extent, with some living in fear of what the impact of the next flare-up could bring., Conclusion: COPD impairs people's ability to carry out daily tasks, leads to hospital admission, time off work and even unemployment. Respondents reported stress, worry and depression or low mood because of their COPD. This study highlights areas of concern for patients not being addressed by health care practitioners, including: pulmonary rehabilitation referral, better information giving and medicines optimization., Competing Interests: Mr Steve Titmarsh and Mr Richard E Russell report personal fees from Chiesi Limited to draft this article. Mr Michele Poliziani inputted into the article and reviewed its content as part of his work on the patient survey. Editorial assistance was provided by M&F Health, London on behalf of Chiesi Limited. The authors report no other conflicts of interest in this work., (© 2019 Titmarsh et al.)

Background: Inhaled medications for cystic fibrosis (CF) are effective but adherence is low. Clinicians find it difficult to estimate how much treatment people with CF (PWCF) take, whilst objective adherence measurement demonstrates that patients are poorly calibrated with a tendency to over-estimate actual adherence. The diagnostic approach to a PWCF with deteriorating clinical status and very low adherence is likely to be different to the approach to a deteriorating patient with optimal adherence. Access to objective adherence data in routine consultations could help to overcome diagnostic challenges for clinicians and people with CF. Attitudes of clinicians to the use and importance of routinely available adherence data is unknown. Methods: We conducted an online questionnaire survey with UK CF centres. We asked five questions relating to the current use and perception of objective measurements of adherence in routine care. Results: A total of eight CF centres completed the questionnaire. Few of the responding centres have adherence data readily available in routine clinics (13% of centres use medicines possession ratio; of centres with access to I-nebs® it was estimated that 17% of patients had I-neb data regularly available in clinics). All centres considered the availability of objectively measured adherence data to be important. Respondents identified that systems developed to provide adherence data in clinical practice must provide data to both clinicians and patients that is readily understood and easy to use. Conclusions: Centres perceived the availability of adherence data in routine care to be important but objective measures of adherence is rarely available at present., Competing Interests: Competing interests: Martin Wildman is the Chief Investigator on the CFHealthHub programme that has developed a system to capture and provide adherence data in the UK., (Copyright: © 2019 Robinson L et al.)

Objectives: The National Health Service (NHS) in England recently introduced general practice pharmacists (GPPs) to provide medication-focused support to both patients and the general practice team. This healthcare model may benefit people with asthma, who currently receive suboptimal care and demonstrate low medication adherence. This study aimed to explore the perspectives of adults with asthma on the potential for pharmacist-led adherence support delivered in general practice, with a focus on how these perspectives are formed., Design and Setting: The study was conducted in the United Kingdom (UK) utilising a qualitative interview methodology. Participants were invited to partake in a telephone-based semistructured interview, followed by an online questionnaire for demographic details and asthma history. Qualitative data were analysed using thematic analysis., Participants: Participants (n=17) were adults with asthma in the UK with a prescription for an inhaled corticosteroid. Participants did not have previous experience with GPPs and were asked to provide their views on a proposed GPP-led service., Results: Participant perspectives of GPPs were determined by trust in pharmacists, perceived gaps in asthma care and the perceived strain on the NHS. Trust was based on pharmacists' perceived clinical competency, established over time, and gauged through a 'benchmarking' process. GPP's fit in current asthma care was assessed based on potential role overlap with other healthcare professionals, continuity of care and medication-related support needs. Participants navigated the NHS based on a perceived hierarchy of healthcare professionals (general practitioners on top, nurses, then pharmacists), and this influenced their perspectives of GPPs., Conclusion: While the GPP scheme shows promise based on the perspectives of people with asthma, the identified barriers to optimal patient engagement and service implementation will need to be addressed for the service to be effective., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Aims: Bone health assessment and the prescription of medication for secondary fracture prevention have become an integral part of the acute management of patients with hip fracture. However, there is little evidence regarding compliance with prescription guidelines and subsequent adherence to medication in this patient group., Patients and Methods: The World Hip Trauma Evaluation (WHiTE) is a multicentre, prospective cohort of hip fracture patients in NHS hospitals in England and Wales. Patients aged 60 years and older who received operative treatment for a hip fracture were eligible for inclusion in WHiTE. The prescription of bone protection medications was recorded from participants' discharge summaries, and participant-reported use of bone protection medications was recorded at 120 days following surgery., Results: Of 5456 recruited patients with baseline data, 2853 patients (52%) were prescribed bone protection medication at discharge, of which oral bisphosphonates were the most common, 4109 patients (75%) were prescribed vitamin D or calcium, and 606 patients (11%) were not prescribed anything. Of those prescribed a bone protection medication, only 932 patients (33%) reported still taking their medication 120 days later., Conclusion: These data provide a reference for current prescription and adherence rates. Adherence with oral medication remains poor in patients with hip fracture. Cite this article: Bone Joint J 2019;101-B:1402-1407.