Management of antipsychotics in primary care: Insights from healthcare professionals and policy makers in the United Kingdom.

INTRODUCTION: Antipsychotic medication is increasingly prescribed to patients with serious mental illness. Patients with serious mental illness often have cardiovascular and metabolic comorbidities, and antipsychotics independently increase the risk of cardiometabolic disease. Despite this, many patients prescribed antipsychotics are discharged to primary care without planned psychiatric review. We explore perceptions of healthcare professionals and managers/directors of policy regarding reasons for increasing prevalence and management of antipsychotics in primary care. METHODS: Qualitative study using semi-structured interviews with 11 general practitioners (GPs), 8 psychiatrists, and 11 managers/directors of policy in the United Kingdom. Data was analysed using thematic analysis. RESULTS: Respondents reported competency gaps that impaired ability to manage patients prescribed antipsychotic medications, arising from inadequate postgraduate training and professional development. GPs lacked confidence to manage antipsychotic medications alone; psychiatrists lacked skills to address cardiometabolic risks and did not perceive this as their role. Communication barriers, lack of integrated care records, limited psychology provision, lowered expectation towards patients with serious mental illness by professionals, and pressure to discharge from hospital resulted in patients in primary care becoming 'trapped' on antipsychotics, inhibiting opportunities to deprescribe. Organisational and contractual barriers between services exacerbate this risk, with socioeconomic deprivation and lack of access to non-pharmacological interventions driving overprescribing. Professionals voiced fears of censure if a catastrophic event occurred after stopping an antipsychotic. Facilitators to overcome these barriers were suggested. CONCLUSIONS: People prescribed antipsychotics experience a fragmented health system and suboptimal care. Several interventions could be taken to improve care for this population, but inadequate availability of non-pharmacological interventions and socioeconomic factors increasing mental distress need policy change to improve outcomes. The role of professionals' fear of medicolegal or regulatory censure inhibiting antipsychotic deprescribing was a new finding in this study.

EXPERTS II - How are patient and caregiver participation in health and social care shaped by experienced burden of treatment and social inequalities? Protocol for a qualitative synthesis.

Background: The workload health and social care service users and caregivers take on, and their capacity to do this work is important. It may play a key part in shaping the implementation of innovations in health service delivery and organisation; the utilisation and satisfaction with services; and the outcomes of care. Previous research has often focused on experiences of a narrow range of long-term conditions, and on factors that shape adherence to self-care regimes. Aims: With the aim of deriving policy and practice implications for service redesign, this evidence synthesis will extend our understanding of service user and caregiver workload and capacity by comparing how they are revealed in qualitative studies of lived experience of three kinds of illness trajectories: long-term conditions associated with significant disability (Parkinson's disease, schizophrenia); serious relapsing remitting disease (Inflammatory Bowel Disease, bipolar disorder); and rapidly progressing acute disease (brain cancer, early onset dementia). Methods: We will review and synthesise qualitative studies of lived experience of participation in health and social care that are shaped by interactions between experienced treatment burdens, social inequalities and illness trajectories. The review will involve:   1.  Construction of a theory-informed coding manual; systematic search of bibliographic databases to identify, screen and quality assess full-text papers.   2.  Analysis of papers using manual coding techniques, and text mining software; construction of taxonomies of service user and caregiver work and capacity.   3.  Designing a model of core components and identifying common factors across conditions, trajectories, and contexts.   4.  Work with practitioners, and a Patient and Public Involvement (PPI) group, to explore the validity of the models produced; to develop workload reduction strategies; and to consider person-centred service design. Dissemination: We will promote workload reduction models to support service users and caregivers and produce policy briefs and peer-reviewed publications for practitioners, policy-makers, and researchers.

Our experiences of illness are often complex. We may have to work hard too. We may need to monitor and record symptoms: take up different diets and physical activity; use different drugs and medical devices; develop expertise in using websites and information technology; coordinate input from health and care services; sometimes we have to work out how to pay for the services we need. How we get through this work is affected by our capacity to do it, and that is shaped by personal and wider resources, we can draw on. All of this is also affected by the services that are available to us, and by the ways our chances in life are shaped by income, ethnicity, education, gender, and age. The kinds of illnesses we have and how they progress, mean that these factors change over time. We call these changes trajectories. To better understand service user work and capacity, we will review published studies that tell us about people's everyday experiences of living with illnesses. We focus on three rarely studied trajectories. These are long-term conditions associated with significant disability; serious relapsing remitting disease; and rapidly progressing acute disease. We will first use existing research to build a framework in which we can describe and understand relevant aspects of the published studies. We will use this framework to extract relevant information from the studies. This will enable us to make a model of common features of service user work and capacity across different conditions, their trajectories, service organisation and delivery, and patterns of social and economic disadvantage. Finally, we will work with groups of service users and caregivers, and with health and social care professionals to apply the model to the development of strategies to reduce workload and improve service design for people with complex health problems.

Protocol for a pilot randomised controlled trial to evaluate integrated support from pharmacist independent prescriber and third sector worker for people experiencing homelessness: the PHOENIx community pharmacy study.

BACKGROUND: People experiencing homelessness (PEH) have complex health and social care needs and most die in their early 40 s. PEH frequently use community pharmacies; however, evaluation of the delivery of structured, integrated, holistic health and social care intervention has not been previously undertaken in community pharmacies for PEH. PHOENIx (Pharmacy Homeless Outreach Engagement Non-medical Independent prescribing Rx) has been delivered and tested in Glasgow, Scotland, by NHS pharmacist independent prescribers and third sector homelessness support workers offering health and social care intervention in low threshold homeless drop-in venues, emergency accommodation and emergency departments, to PEH. Building on this work, this study aims to test recruitment, retention, intervention adherence and fidelity of community pharmacy-based PHOENIx intervention. METHODS: Randomised, multi-centre, open, parallel-group external pilot trial. A total of 100 PEH aged 18 years and over will be recruited from community pharmacies in Glasgow and Birmingham. PHOENIx intervention includes structured assessment in the community pharmacy of health, housing, benefits and activities, in addition to usual care, through weekly visits lasting up to six months. A primary outcome is whether to proceed to a definitive trial based on pre-specified progression criteria. Secondary outcomes include drug/alcohol treatment uptake and treatment retention; overdose rates; mortality and time to death; prison/criminal justice encounters; healthcare utilisation; housing tenure; patient-reported measures and intervention acceptability. Analysis will include descriptive statistics of recruitment and retention rates. Process evaluation will be conducted using Normalisation Process Theory. Health, social care and personal resource use data will be identified, measured and valued. DISCUSSION: If the findings of this pilot study suggest progression to a definitive trial, and if the definitive trial offers positive outcomes, it is intended that PHOENIx will be a publicly funded free-to-access service in community pharmacy for PEH. The study results will be shared with wider stakeholders and patients in addition to dissemination through medical journals and scientific conferences. TRIAL REGISTRATION: International Clinical Trial Registration ISRCTN88146807. Approved protocol version 2.0 dated July 19, 2022.

The influence of socioeconomic status on the association between unhealthy lifestyle factors and adverse health outcomes: a systematic review.

Background: Combinations of lifestyle factors (LFs) and socioeconomic status (SES) are independently associated with cardiovascular disease (CVD), cancer, and mortality. Less advantaged SES groups may be disproportionately vulnerable to unhealthy LFs but interactions between LFs and SES remain poorly understood. This review aimed to synthesise the available evidence for whether and how SES modifies associations between combinations of LFs and adverse health outcomes. Methods: Systematic review of studies that examine associations between combinations of >3 LFs (eg.smoking/physical activity/diet) and health outcomes and report data on SES (eg.income/education/poverty-index) influences on associations. Databases (PubMed/EMBASE/CINAHL), references, forward citations, and grey-literature were searched from inception to December 2021. Eligibility criteria were analyses of prospective adult cohorts that examined all-cause mortality or CVD/cancer mortality/incidence. Results: Six studies (n=42,467-399,537; 46.5-56.8 years old; 54.6-59.3% women) of five cohorts were included. All examined all-cause mortality; three assessed CVD/cancer outcomes. Four studies observed multiplicative interactions between LFs and SES, but in opposing directions. Two studies tested for additive interactions; interactions were observed in one cohort (UK Biobank) and not in another (National Health and Nutrition Examination Survey (NHANES)). All-cause mortality HRs (95% confidence intervals) for unhealthy LFs (versus healthy LFs) from the most advantaged SES groups ranged from 0.68 (0.32-1.45) to 4.17 (2.27-7.69). Equivalent estimates from the least advantaged ranged from 1.30 (1.13-1.50) to 4.00 (2.22-7.14). In 19 analyses (including sensitivity analyses) of joint associations between LFs, SES, and all-cause mortality, highest all-cause mortality was observed in the unhealthiest LF-least advantaged suggesting an additive effect. Conclusions: Limited and heterogenous literature suggests that the influence of SES on associations between combinations of unhealthy LFs and adverse health could be additive but remains unclear. Additional prospective analyses would help clarify whether SES modifies associations between combinations of unhealthy LFs and health outcomes. Registration: Protocol is registered with PROSPERO (CRD42020172588;25 June 2020).

Associations between multimorbidity and adverse health outcomes in UK Biobank and the SAIL Databank: A comparison of longitudinal cohort studies.

BACKGROUND: Cohorts such as UK Biobank are increasingly used to study multimorbidity; however, there are concerns that lack of representativeness may lead to biased results. This study aims to compare associations between multimorbidity and adverse health outcomes in UK Biobank and a nationally representative sample. METHODS AND FINDINGS: These are observational analyses of cohorts identified from linked routine healthcare data from UK Biobank participants (n = 211,597 from England, Scotland, and Wales with linked primary care data, age 40 to 70, mean age 56.5 years, 54.6% women, baseline assessment 2006 to 2010) and from the Secure Anonymised Information Linkage (SAIL) databank (n = 852,055 from Wales, age 40 to 70, mean age 54.2, 50.0% women, baseline January 2011). Multimorbidity (n = 40 long-term conditions [LTCs]) was identified from primary care Read codes and quantified using a simple count and a weighted score. Individual LTCs and LTC combinations were also assessed. Associations with all-cause mortality, unscheduled hospitalisation, and major adverse cardiovascular events (MACEs) were assessed using Weibull or negative binomial models adjusted for age, sex, and socioeconomic status, over 7.5 years follow-up for both datasets. Multimorbidity was less common in UK Biobank than SAIL (26.9% and 33.0% with ≥2 LTCs in UK Biobank and SAIL, respectively). This difference was attenuated, but persisted, after standardising by age, sex, and socioeconomic status. The association between increasing multimorbidity count and mortality, hospitalisation, and MACE was similar between both datasets at LTC counts of ≤3; however, above this level, UK Biobank underestimated the risk associated with multimorbidity (e.g., mortality hazard ratio for 2 LTCs 1.62 (95% confidence interval 1.57 to 1.68) in SAIL and 1.51 (1.43 to 1.59) in UK Biobank, hazard ratio for 5 LTCs was 3.46 (3.31 to 3.61) in SAIL and 2.88 (2.63 to 3.15) in UK Biobank). Absolute risk of mortality, hospitalisation, and MACE, at all levels of multimorbidity, was lower in UK Biobank than SAIL (adjusting for age, sex, and socioeconomic status). Both cohorts produced similar hazard ratios for some LTCs (e.g., hypertension and coronary heart disease), but UK Biobank underestimated the risk for others (e.g., alcohol-related disorders or mental health conditions). Hazard ratios for some LTC combinations were similar between the cohorts (e.g., cardiovascular conditions); however, UK Biobank underestimated the risk for combinations including other conditions (e.g., mental health conditions). The main limitations are that SAIL databank represents only part of the UK (Wales only) and that in both cohorts we lacked data on severity of the LTCs included. CONCLUSIONS: In this study, we observed that UK Biobank accurately estimates relative risk of mortality, unscheduled hospitalisation, and MACE associated with LTC counts ≤3. However, for counts ≥4, and for some LTC combinations, estimates of magnitude of association from UK Biobank are likely to be conservative. Researchers should be mindful of these limitations of UK Biobank when conducting and interpreting analyses of multimorbidity. Nonetheless, the richness of data available in UK Biobank does offers opportunities to better understand multimorbidity, particularly where complementary data sources less susceptible to selection bias can be used to inform and qualify analyses of UK Biobank.

The readability of general practice websites: a cross-sectional analysis of all general practice websites in Scotland.

BACKGROUND: General practice websites are an increasingly important point of interaction, but their readability is largely unexplored. One in four adults struggle with basic literacy, and there is a socioeconomic gradient. Readable content is a prerequisite to promoting health literacy. AIM: To assess general practice website readability by analysing text and design factors, and to assess whether practices adapted their website text to the likely literacy levels of their populations. DESIGN AND SETTING: Websites for all general practices across Scotland were analysed from March to December 2019, using a cross-sectional design. METHOD: Text was extracted from five webpages per website and eight text readability factors were measured, including the Flesch Reading Ease and the Flesch-Kincaid Grade Level. The relationship between readability and a practice population's level of deprivation, measured using the Scottish Index of Multiple Deprivation (SIMD), was assessed. Overall, 10 design factors contributing to readability and accessibility were scored. RESULTS: In total, 86.4% (n = 813/941) of Scottish practices had a website; 22.9% (n = 874/3823) of webpages were written at, or below, the government-recommended reading level for online content (9-14 years old), and the content of the remaining websites, 77.1% (n = 2949/3823), was suitable for a higher reading age. Of all webpages, 80.5% (n = 3077/3823) were above the recommended level for easy-to-understand 'plain English'. There was no statistically significant association between webpage reading age and SIMD. Only 6.7% (n = 51/764) of websites achieved all design and accessibility recommendations. CONCLUSION: Changes to practice websites could improve readability and promote health literacy, but practices will need financial resources and ongoing technical support if this is to be achieved and maintained. Failure to provide readable and accessible websites may widen health inequalities; the topic will become increasingly important as online service use accelerates.

Home and Online Management and Evaluation of Blood Pressure (HOME BP) using a digital intervention in poorly controlled hypertension: randomised controlled trial.

OBJECTIVE: The HOME BP (Home and Online Management and Evaluation of Blood Pressure) trial aimed to test a digital intervention for hypertension management in primary care by combining self-monitoring of blood pressure with guided self-management. DESIGN: Unmasked randomised controlled trial with automated ascertainment of primary endpoint. SETTING: 76 general practices in the United Kingdom. PARTICIPANTS: 622 people with treated but poorly controlled hypertension (>140/90 mm Hg) and access to the internet. INTERVENTIONS: Participants were randomised by using a minimisation algorithm to self-monitoring of blood pressure with a digital intervention (305 participants) or usual care (routine hypertension care, with appointments and drug changes made at the discretion of the general practitioner; 317 participants). The digital intervention provided feedback of blood pressure results to patients and professionals with optional lifestyle advice and motivational support. Target blood pressure for hypertension, diabetes, and people aged 80 or older followed UK national guidelines. MAIN OUTCOME MEASURES: The primary outcome was the difference in systolic blood pressure (mean of second and third readings) after one year, adjusted for baseline blood pressure, blood pressure target, age, and practice, with multiple imputation for missing values. RESULTS: After one year, data were available from 552 participants (88.6%) with imputation for the remaining 70 participants (11.4%). Mean blood pressure dropped from 151.7/86.4 to 138.4/80.2 mm Hg in the intervention group and from 151.6/85.3 to 141.8/79.8 mm Hg in the usual care group, giving a mean difference in systolic blood pressure of -3.4 mm Hg (95% confidence interval -6.1 to -0.8 mm Hg) and a mean difference in diastolic blood pressure of -0.5 mm Hg (-1.9 to 0.9 mm Hg). Results were comparable in the complete case analysis and adverse effects were similar between groups. Within trial costs showed an incremental cost effectiveness ratio of £11 ($15, €12; 95% confidence interval £6 to £29) per mm Hg reduction. CONCLUSIONS: The HOME BP digital intervention for the management of hypertension by using self-monitored blood pressure led to better control of systolic blood pressure after one year than usual care, with low incremental costs. Implementation in primary care will require integration into clinical workflows and consideration of people who are digitally excluded. TRIAL REGISTRATION: ISRCTN13790648.

Ethnic and socioeconomic differences in SARS-CoV-2 infection: prospective cohort study using UK Biobank.

BACKGROUND: Understanding of the role of ethnicity and socioeconomic position in the risk of developing SARS-CoV-2 infection is limited. We investigated this in the UK Biobank study. METHODS: The UK Biobank study recruited 40-70-year-olds in 2006-2010 from the general population, collecting information about self-defined ethnicity and socioeconomic variables (including area-level socioeconomic deprivation and educational attainment). SARS-CoV-2 test results from Public Health England were linked to baseline UK Biobank data. Poisson regression with robust standard errors was used to assess risk ratios (RRs) between the exposures and dichotomous variables for being tested, having a positive test and testing positive in hospital. We also investigated whether ethnicity and socioeconomic position were associated with having a positive test amongst those tested. We adjusted for covariates including age, sex, social variables (including healthcare work and household size), behavioural risk factors and baseline health. RESULTS: Amongst 392,116 participants in England, 2658 had been tested for SARS-CoV-2 and 948 tested positive (726 in hospital) between 16 March and 3 May 2020. Black and south Asian groups were more likely to test positive (RR 3.35 (95% CI 2.48-4.53) and RR 2.42 (95% CI 1.75-3.36) respectively), with Pakistani ethnicity at highest risk within the south Asian group (RR 3.24 (95% CI 1.73-6.07)). These ethnic groups were more likely to be hospital cases compared to the white British. Adjustment for baseline health and behavioural risk factors led to little change, with only modest attenuation when accounting for socioeconomic variables. Socioeconomic deprivation and having no qualifications were consistently associated with a higher risk of confirmed infection (RR 2.19 for most deprived quartile vs least (95% CI 1.80-2.66) and RR 2.00 for no qualifications vs degree (95% CI 1.66-2.42)). CONCLUSIONS: Some minority ethnic groups have a higher risk of confirmed SARS-CoV-2 infection in the UK Biobank study, which was not accounted for by differences in socioeconomic conditions, baseline self-reported health or behavioural risk factors. An urgent response to addressing these elevated risks is required.

Is there an association between socioeconomic status of General Practice population and postgraduate training practice accreditation? A cross-sectional analysis of Scottish General Practices.

BACKGROUND: Practice population socioeconomic status is associated with practice postgraduate training accreditation. General Practitioner recruitment to socioeconomically deprived areas is challenging, exposure during training may encourage recruitment. OBJECTIVES: To determine the association of practice population socioeconomic deprivation score and training status, and if this has changed over time. METHODS: Cross-sectional study looking at socioeconomic deprivation and training status for all General Practices in Scotland (n = 982). Data from Information Services Division, from 2015, were combined with the Scottish Index of Multiple Deprivation to calculate weighted socioeconomic deprivation scores for every practice in Scotland. Scottish training body database identified training practices (n = 330). Mean deprivation score for training and non-training practices was calculated. Logistic regression was used to quantify the odds ratio of training status based on deprivation score, adjusted for practice list size, and compared with a similar 2009 analysis. RESULTS: Socioeconomic deprivation score is associated with training status, but is not significant when adjusted for practice list size [OR (adjusted) 0.87, 95% CI: 0.74-1.04]. In contrast, in 2009, adjusted deprivation score remained significant. Mean deprivation score in training and non-training practices remained similar at both time points [2015: 2.98 (SD 0.88) versus 3.17 (SD 0.81); 2009: 2.95 versus 3.19), with a more deprived mean score in non-training practices. CONCLUSIONS: General practices in affluent areas remain more likely to train, although this association appears to be related to larger practice list sizes rather than socioeconomic factors. To ensure a variety of training environments training bodies should target, and support, smaller practices working in more socioeconomically deprived areas.

Valuing Mobile Health: An Open-Ended Contingent Valuation Survey of a National Digital Health Program.

BACKGROUND: Changing population demographics and technology developments have resulted in growing interest in the potential of consumer-facing digital health. In the United Kingdom, a £37 million (US $49 million) national digital health program delivering assisted living lifestyles at scale (dallas) aimed to deploy such technologies at scale. However, little is known about how consumers value such digital health opportunities. OBJECTIVE: This study explored consumers' perspectives on the potential value of digital health technologies, particularly mobile health (mHealth), to promote well-being by examining their willingness-to-pay (WTP) for such health solutions. METHODS: A contingent valuation study involving a UK-wide survey that asked participants to report open-ended absolute and marginal WTP or willingness-to-accept for the gain or loss of a hypothetical mHealth app, Healthy Connections. RESULTS: A UK-representative cohort (n=1697) and a dallas-like (representative of dallas intervention communities) cohort (n=305) were surveyed. Positive absolute and marginal WTP valuations of the app were identified across both cohorts (absolute WTP: UK-representative cohort £196 or US $258 and dallas-like cohort £162 or US $214; marginal WTP: UK-representative cohort £160 or US $211 and dallas-like cohort £151 or US $199). Among both cohorts, there was a high prevalence of zeros for both the absolute WTP (UK-representative cohort: 467/1697, 27.52% and dallas-like cohort: 95/305, 31.15%) and marginal WTP (UK-representative cohort: 487/1697, 28.70% and dallas-like cohort: 99/305, 32.5%). In both cohorts, better general health, previous amount spent on health apps (UK-representative cohort 0.64, 95% CI 0.27 to 1.01; dallas-like cohort: 1.27, 95% CI 0.32 to 2.23), and age had a significant (P>.00) association with WTP (UK-representative cohort: -0.1, 95% CI -0.02 to -0.01; dallas-like cohort: -0.02, 95% CI -0.03 to -0.01), with younger participants willing to pay more for the app. In the UK-representative cohort, as expected, higher WTP was positively associated with income up to £30,000 or US $39,642 (0.21, 95% CI 0.14 to 0.4) and increased spending on existing phone and internet services (0.52, 95% CI 0.30 to 0.74). The amount spent on existing health apps was shown to be a positive indicator of WTP across cohorts, although the effect was marginal (UK-representative cohort 0.01, 95% CI 0.01 to 0.01; dallas-like cohort 0.01, 95% CI 0.01 to 0.02). CONCLUSIONS: This study demonstrates that consumers value mHealth solutions that promote well-being, social connectivity, and health care control, but it is not universally embraced. For mHealth to achieve its potential, apps need to be tailored to user accessibility and health needs, and more understanding of what hinders frequent users of digital technologies and those with long-term conditions is required. This novel application of WTP in a digital health context demonstrates an economic argument for investing in upskilling the population to promote access and expedite uptake and utilization of such digital health and well-being apps.

The effect of socioeconomic deprivation on the association between an extended measurement of unhealthy lifestyle factors and health outcomes: a prospective analysis of the UK Biobank cohort.

BACKGROUND: Combinations of lifestyle factors interact to increase mortality. Combinations of traditional factors such as smoking and alcohol are well described, but the additional effects of emerging factors such as television viewing time are not. The effect of socioeconomic deprivation on these extended lifestyle risks also remains unclear. We aimed to examine whether deprivation modifies the association between an extended score of lifestyle-related risk factors and health outcomes. METHODS: Data for this prospective analysis were sourced from the UK Biobank, a prospective population-based cohort study. We assigned all participants an extended lifestyle score, with 1 point for each unhealthy lifestyle factor (incorporating sleep duration and high television viewing time, in addition to smoking, excessive alcohol, poor diet [low intake of oily fish or fruits and vegetables, and high intake of red meat or processed meats], and low physical activity), categorised as most healthy (score 0-2), moderately healthy (score 3-5), or least healthy (score 6-9). Cox proportional hazards models were used to examine the association between lifestyle score and health outcomes (all-cause mortality and cardiovascular disease mortality and incidence), and whether this association was modified by deprivation. All analyses were landmark analyses, in which participants were excluded if they had an event (death or cardiovascular disease event) within 2 years of recruitment. Participants with non-communicable diseases (except hypertension) and missing covariate data were excluded from analyses. Participants were also excluded if they reported implausible values for physical activity, sleep duration, and total screen time. All analyses were adjusted for age, sex, ethnicity, month of assessment, history of hypertension, systolic blood pressure, medication for hypercholesterolaemia or hypertension, and body-mass index categories. FINDINGS: 328 594 participants aged 40-69 years were included in the study, with a mean follow-up period of 4·9 years (SD 0·83) after the landmark period for all-cause and cardiovascular disease mortality, and 4·1 years (0·81) for cardiovascular disease incidence. In the least deprived quintile, the adjusted hazard ratio (HR) in the least healthy lifestyle category, compared with the most healthy category, was 1·65 (95% CI 1·25-2·19) for all-cause mortality, 1·93 (1·16-3·20) for cardiovascular disease mortality, and 1·29 (1·10-1·52) for cardiovascular disease incidence. Equivalent HRs in the most deprived quintile were 2·47 (95% CI 2·04-3·00), 3·36 (2·36-4·76), and 1·41 (1·25-1·60), respectively. The HR for trend for one increment change towards least healthy in the least deprived quintile compared with that in the most deprived quintile was 1·25 (95% CI 1·12-1·39) versus 1·55 (1·40-1·70) for all-cause mortality, 1·30 (1·05-1·61) versus 1·83 (1·54-2·18) for cardiovascular disease mortality, and 1·10 (1·04-1·17) versus 1·16 (1·09-1·23) for cardiovascular disease incidence. A significant interaction was found between lifestyle and deprivation for all-cause and cardiovascular disease mortality (both pinteraction<0·0001), but not for cardiovascular disease incidence (pinteraction=0·11). INTERPRETATION: Wide combinations of lifestyle factors are associated with disproportionate harm in deprived populations. Social and fiscal policies that reduce poverty are needed alongside public health and individual-level interventions that address a wider range of lifestyle factors in areas of deprivation. FUNDING: None.

A conceptual model of treatment burden and patient capacity in stroke.

BACKGROUND: Treatment burden is the workload of healthcare experienced by those with long-term conditions and the impact that this has on well-being. Treatment burden can negatively impact on quality of life and adherence to treatments. Individuals are likely to differ in their ability to manage health problems and follow treatments, defined as patient capacity. This has been under investigated in stroke. The aim of this paper is to create a conceptual model of treatment burden and patient capacity for people who have had a stroke through exploration of their experiences of healthcare. METHODS: Interviews were conducted at home with 29 individuals who have had a stroke. These were recorded and transcribed verbatim. Fifteen explored treatment burden and were analysed by framework analysis underpinned by Normalisation Process Theory (NPT). Fourteen explored patient capacity and were analysed by thematic analysis. Taxonomies of treatment burden and patient capacity were created and a conceptual model produced. RESULTS: Mean age was 68 years. Sixteen were men and 13 women. The following broad areas of treatment burden were identified: making sense of stroke management and planning care; interacting with others including health professionals, family and other stroke patients; enacting management strategies; and reflecting on management. Treatment burdens were identified as arising from either: the workload of healthcare; or the endurance of care deficiencies. Six factors were identified that influence patient capacity: personal attributes and skills; physical and cognitive abilities; support network; financial status; life workload, and environment. CONCLUSIONS: Healthcare workload and the presence of care deficiencies can influence and be influenced by patient capacity. The quality and configuration of health and social care services has considerable influence on treatment burden and patient capacity. Findings have important implications for the design of clinical guidelines and healthcare delivery, highlighting issues such as the importance of good care co-ordination.

Measuring the burden of treatment for chronic disease: implications of a scoping review of the literature.

BACKGROUND: Although there has been growing research on the burden of treatment, the current state of evidence on measuring this concept is unknown. This scoping review aimed to provide an overview of the current state of knowledge as well as clear recommendations for future research, within the context of chronic disease. METHODS: Four health-based databases, Scopus, CINAHL, Medline, and PsychInfo, were comprehensively searched for peer-reviewed articles published between the periods of 2000-2016. Titles and abstracts were independently read by two authors. All discrepancies between the authors were resolved by a third author. Data was extracted using a standardized proforma and a comparison analysis was used in order to explore the key treatment burden measures and categorize them into three groups. RESULTS: Database searching identified 1458 potential papers. After removal of duplications, and irrelevant articles by title, 1102 abstracts remained. An additional 22 papers were added via snowball searching. In the end, 101 full papers were included in the review. A large number of the studies involved quantitative measures and conceptualizations of treatment burden (n = 64; 63.4%), and were conducted in North America (n = 49; 48.5%). There was significant variation in how the treatment burden experienced by those with chronic disease was operationalized and measured. CONCLUSION: Despite significant work, there is still much ground to cover to comprehensively measure treatment burden for chronic disease. Greater qualitative focus, more research with cultural and minority populations, a larger emphasis on longitudinal studies and the consideration of the potential effects of "identity" on treatment burden, should be considered.

Supporting the use of theory in cross-country health services research: a participatory qualitative approach using Normalisation Process Theory as an example.

OBJECTIVES: To describe and reflect on the process of designing and delivering a training programme supporting the use of theory, in this case Normalisation Process Theory (NPT), in a multisite cross-country health services research study. DESIGN: Participatory research approach using qualitative methods. SETTING: Six European primary care settings involving research teams from Austria, England, Greece, Ireland, The Netherlands and Scotland. PARTICIPANTS: RESTORE research team consisting of 8 project applicants, all senior primary care academics, and 10 researchers. Professional backgrounds included general practitioners/family doctors, social/cultural anthropologists, sociologists and health services/primary care researchers. PRIMARY OUTCOME MEASURES: Views of all research team members (n=18) were assessed using qualitative evaluation methods, analysed qualitatively by the trainers after each session. RESULTS: Most of the team had no experience of using NPT and many had not applied theory to prospective, qualitative research projects. Early training proved didactic and overloaded participants with information. Drawing on RESTORE's methodological approach of Participatory Learning and Action, workshops using role play, experiential interactive exercises and light-hearted examples not directly related to the study subject matter were developed. Evaluation showed the study team quickly grew in knowledge and confidence in applying theory to fieldwork.Recommendations applicable to other studies include: accepting that theory application is not a linear process, that time is needed to address researcher concerns with the process, and that experiential, interactive learning is a key device in building conceptual and practical knowledge. An unanticipated benefit was the smooth transition to cross-country qualitative coding of study data. CONCLUSION: A structured programme of training enhanced and supported the prospective application of a theory, NPT, to our work but raised challenges. These were not unique to NPT but could arise with the application of any theory, especially in large multisite, international projects. The lessons learnt are applicable to other theoretically informed studies.

Interventions by healthcare professionals to improve management of physical long-term conditions in adults who are homeless: a systematic review protocol.

INTRODUCTION: People experiencing homelessness are at increased risk of, and have poorer outcomes from, a range of physical long-term conditions (LTCs). It is increasingly recognised that interventions targeting people who are homeless should be tailored to the specific needs of this population. This systematic review aims to identify, describe and appraise trials of interventions that aim to manage physical LTCs in homeless adults and are delivered by healthcare professionals. METHODS AND ANALYSIS: Seven electronic databases (Medline, EMBASE, Cochrane Central Register of Controlled Trials, Assia, Scopus, PsycINFO and CINAHL) will be searched from 1960 (or inception) to October 2016 and supplemented by forward citation searching, handsearching of reference lists and searching grey literature. Two reviewers will independently review titles, abstract and full-texts using DistillerSR software. Inclusion criteria include (1) homeless adults with any physical LTC, (2) interventions delivered by a healthcare professional (any professional trained to provide any form of healthcare, but excluding social workers and professionals without health-related training), (3) comparison with usual care or an alternative intervention, (4) report outcomes such as healthcare usage, physical and psychological health or well-being or cost-effectiveness, (5) randomised controlled trials, non-randomised controlled trials, controlled before-after studies. Quality will be assessed using the Cochrane EPOC Risk of Bias Tool. A meta-analysis will be performed if sufficient data are identified; however, we anticipate a narrative synthesis will be performed. ETHICS AND DISSEMINATION: This review will synthesise existing evidence for interventions delivered by healthcare professionals to manage physical LTCs in adults who are homeless. The findings will inform the development of future interventions and research aiming to improve the management of LTCs for people experiencing homelessness. Ethical approval will not be required for this systematic review as it does not contain individual patient data. We will disseminate the results of this systematic review via conference presentations, healthcare professional networks, social media and peer-reviewed publication. TRIAL REGISTRATION NUMBER: PROSPERO registration number: CRD42016046183.

Incentivised chronic disease management and the inverse equity hypothesis: findings from a longitudinal analysis of Scottish primary care practice-level data.

BACKGROUND: The inverse equity hypothesis asserts that new health policies initially widen inequality, then attenuate inequalities over time. Since 2004, the UK's pay-for-performance scheme for chronic disease management (CDM) in primary care general practices (the Quality and Outcomes Framework) has permitted practices to except (exclude) patients from attending annual CDM reviews, without financial penalty. Informed dissent (ID) is one component of exception rates, applied to patients who have not attended due to refusal or non-response to invitations. 'Population achievement' describes the proportion receiving care, in relation to those eligible to receive it, including excepted patients. Examination of exception reporting (including ID) and population achievement enables the equity impact of the UK pay-for-performance contract to be assessed. We conducted a longitudinal analysis of practice-level rates and of predictors of ID, overall exceptions and population achievement for CDM to examine whether the inverse equity hypothesis holds true. METHODS: We carried out a retrospective, longitudinal study using routine primary care data, analysed by multilevel logistic regression. Data were extracted from 793 practices (83% of Scottish general practices) serving 4.4 million patients across Scotland from 2010/2011 to 2012/2013, for 29 CDM indicators covering 11 incentivised diseases. This provided 68,991 observations, representing a total of 15 million opportunities for exception reporting. RESULTS: Across all observations, the median overall exception reporting rate was 7.0% (7.04% in 2010-2011; 7.02% in 2011-2012 and 6.92% in 2012-2013). The median non-attendance rate due to ID was 0.9% (0.76% in 2010-2011; 0.88% in 2011-2012 and 0.96% in 2012-2013). Median population achievement was 83.5% (83.51% in 2010-2011; 83.41% in 2011-2012 and 83.63% in 2012-2013). The odds of ID reporting in 2012/2013 were 16.0% greater than in 2010/2011 (p < 0.001). Practices in Scotland's most deprived communities were twice as likely to report non-attendance due to ID (odds ratio 2.10, 95% confidence interval 1.83-2.40, p < 0.001) compared with those in the least deprived; rural practices reported lower levels of non-attendance due to ID. These predictors were also independently associated with overall exceptions. Rates of population achievement did not change over time, with higher levels (higher remuneration) associated with increased rates of overall and ID exception and more affluent practices. CONCLUSIONS: Non-attendance for CDM due to ID has risen over time, and higher rates are seen in patients from practices located in disadvantaged areas. This suggests that CDM incentivisation does not conform to the inverse equity hypothesis, because inequalities are widening over time with lower uptake of anticipatory care health checks and CDM reviews noted among those most in need. Incentivised CDM needs to include incentives for engaging with the 'hard to reach' if inequalities in healthcare delivery are to be tackled.

Detection in blood of autoantibodies to tumour antigens as a case-finding method in lung cancer using the EarlyCDT®-Lung Test (ECLS): study protocol for a randomized controlled trial.

BACKGROUND: Lung cancer is the most common cause of cancer related death worldwide. The majority of cases are detected at a late stage when prognosis is poor. The EarlyCDT®-Lung Test detects autoantibodies to abnormal cell surface proteins in the earliest stages of the disease which may allow tumour detection at an earlier stage thus altering prognosis. The primary research question is: Does using the EarlyCDT®-Lung Test to identify those at high risk of lung cancer, followed by X-ray and computed tomography (CT) scanning, reduce the incidence of patients with late-stage lung cancer (III & IV) or unclassified presentation (U) at diagnosis, compared to standard practice? METHODS: A randomised controlled trial of 12 000 participants in areas of Scotland targeting general practices serving patients in the most deprived quintile of the Scottish Index of Multiple Deprivation. Adults aged 50-75 who are at high risk of lung cancer and healthy enough to undergo potentially curative therapy (Performance Status 0-2) are eligible to participate. The intervention is the EarlyCDT®-Lung Test, followed by X-ray and CT in those with a positive result. The comparator is standard clinical practice in the UK. The primary outcome is the difference, after 24 months, between the rates of patients with stage III, IV or unclassified lung cancer at diagnosis. The secondary outcomes include: all-cause mortality; disease specific mortality; a range of morbidity outcomes; cost-effectiveness and measures examining the psychological and behavioural consequences of screening. Participants with a positive test result but for whom the CT scan does not lead to a lung cancer diagnosis will be offered 6 monthly thoracic CTs for 24 months. An initial chest X-ray will be used to determine the speed and the need for contrast in the first screening CT. Participants who are found to have lung cancer will be followed-up to assess both time to diagnosis and stage of disease at diagnosis. DISCUSSION: The study will determine the clinical and cost effectiveness of EarlyCDT®-Lung Test for early lung cancer detection and assess its suitability for a large-scale, accredited screening service. The study will also assess the potential psychological and behavioural harms arising from false positive or false negative results, as well as the potential benefits to patients of true negative EarlyCDT lung test results. A cost-effectiveness model of lung cancer screening based on the results of the EarlyCDT Lung Test study will be developed. TRIAL REGISTRATION: NCT01925625 . August 19, 2013.