A qualitative exploration of the barriers and facilitators to self-managing multiple long-term conditions amongst people experiencing socioeconomic deprivation.

BACKGROUND: Globally, it is estimated that one in three adults live with two or more long-term conditions (multiple long-term conditions, MLTCs), that require self-management. People who experience socioeconomic deprivation face significant health inequalities due to a range of interrelated characteristics that lead to a lack of resources and opportunities. Previous research with underserved populations indicate low levels of trust towards primary care providers and potential barriers for developing patient-healthcare professional relationships. The purpose of this paper is to explore the barriers and facilitators to self-managing MLTCs, amongst people who experience socioeconomic deprivation. METHODS: Semistructured one-to-one interviews with adults (n = 28) living in London and Sheffield, United Kingdom with MLTCs who are experiencing socioeconomic deprivation. Participants were recruited through general practices, community channels and social media. Data were analysed in NVivo using reflexive thematic analysis methods. FINDINGS: Four analytical themes were developed: (1) challenges in accessing healthcare services, financial assistance, and cultural awareness; (2) empowerment and disempowerment through technology, including digital exclusion, and use of technology; (3) impact and causes of exclusion on self-management, including social isolation, area-based and economic exclusion, and health-related stigma and (4) adapting self-management strategies, including cost-effective, and culturally/lifestyle appropriate strategies. CONCLUSIONS: Future health interventions and services need to be developed with consideration of the combined complexities of managing MLTCs while experiencing socioeconomic deprivation. Increased awareness in practitioners and commissioners of the complexities surrounding the lives of people experiencing socioeconomic deprivation, and the need for targeted strategies to promote self-management of MLTCs are of great importa. PATIENT OR PUBLIC CONTRIBUTION: A patient advisory group contributed to all stages of the study, including providing important feedback on study documents (topic guides and recruitment materials), as well as providing critical insights surrounding the interpretation of interview data.

An economic evaluation of universal and targeted case-finding strategies for identifying antenatal depression: a model-based analysis comparing common case-finding instruments.

Half of women with depression in the perinatal period are not identified in routine care, and missed cases reflect inequalities in other areas of maternity care. Case finding (screening) for depression in pregnant women may be a cost-effective strategy to improve identification, and targeted case finding directs finite resources towards the greatest need. We compared the cost-effectiveness of three case-finding strategies: no case finding, universal (all pregnant women), and targeted (only pregnant women with risk factors for antenatal depression, i.e. history of anxiety/depression, age < 20 years, and adverse life events). A decision tree model was developed to represent case finding (at around 20 weeks gestation) and subsequent treatment for antenatal depression (up to 40 weeks gestation). Costs include case finding and treatment. Health benefits are measured as quality-adjusted life years (QALYs). The sensitivity and specificity of case-finding instruments and prevalence and severity of antenatal depression were estimated from a cohort study of pregnant women. Other model parameters were derived from published literature and expert consultation. The most cost-effective case-finding strategy was a two-stage strategy comprising the Whooley questions followed by the PHQ-9. The mean costs were £52 (universal), £61 (no case finding), and £62 (targeted case finding). Both case-finding strategies improve health compared with no case finding. Universal case finding is cost-saving. Costs associated with targeted case finding are similar to no case finding, with greater health gains, although targeted case finding is not cost-effective compared with universal case finding. Universal case finding for antenatal depression is cost-saving compared to no case finding and more cost-effective than targeted case finding.

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.

Effectiveness of self-management interventions for long-term conditions in people experiencing socio-economic deprivation in high-income countries: a systematic review and meta-analysis.

BACKGROUND: Long-term conditions (LTCs) are prevalent in socio-economically deprived populations. Self-management interventions can improve health outcomes, but socio-economically deprived groups have lower participation in them, with potentially lower effectiveness. This review explored whether self-management interventions delivered to people experiencing socio-economic deprivation improve outcomes. METHODS: We searched databases up to November 2022 for randomized trials. We screened, extracted data and assessed the quality of these studies using Cochrane Risk of Bias 2 (RoB2). We narratively synthesized all studies and performed a meta-analysis on eligible articles. We assessed the certainty of evidence using GRADE for articles included in the meta-analysis. RESULTS: The 51 studies included in this review had mixed findings. For the diabetes meta-analysis, there was a statistically significant pooled reduction in haemoglobin A1c (-0.29%). We had moderate certainty in the evidence. Thirty-eight of the study interventions had specific tailoring for socio-economically deprived populations, including adaptions for low literacy and financial incentives. Each intervention had an average of four self-management components. CONCLUSIONS: Self-management interventions for socio-economically deprived populations show promise, though more evidence is needed. Our review suggests that the number of self-management components may not be important. With the increasing emphasis on self-management, to avoid exacerbating health inequalities, interventions should include tailoring for socio-economically deprived individuals.

An economic evaluation of targeted case-finding strategies for identifying postnatal depression: A model-based analysis comparing common case-finding instruments.

BACKGROUND: Half of women with postnatal depression (PND) are not identified in routine care. We aimed to estimate the cost-effectiveness of PND case-finding in women with risk factors for PND. METHODS: A decision tree was developed to represent the one-year costs and health outcomes associated with case-finding and treatment for PND. The sensitivity and specificity of case-finding instruments, and prevalence and severity of PND, for women with ≥1 PND risk factor were estimated from a cohort of postnatal women. Risk factors were history of anxiety/depression, age < 20 years, and adverse life events. Other model parameters were derived from published literature and expert consultation. Case-finding for high-risk women only was compared with no case-finding and universal case-finding. RESULTS: More than half of the cohort had one or more PND risk factor (57.8 %; 95 % CI 52.7 %-62.7 %). The most cost-effective case-finding strategy was the Edinburgh Postnatal Depression Scale with a cut-off of ≥10 (EPDS-10). Among high-risk women, there is a high probability that EPDS-10 case-finding for PND is cost-effective compared to no case-finding (78.5 % at a threshold of £20,000/QALY), with an ICER of £8146/QALY gained. Universal case-finding is even more cost-effective at £2945/QALY gained (versus no case-finding). There is a greater health improvement with universal rather than targeted case-finding. LIMITATIONS: The model includes costs and health benefits for mothers in the first year postpartum, the broader (e.g. families, societal) and long-term impacts are also important. CONCLUSIONS: Universal PND case-finding is more cost-effective than targeted case-finding which itself is more cost-effective than not case-finding.

Self-management of multiple long-term conditions: A systematic review of the barriers and facilitators amongst people experiencing socioeconomic deprivation.

BACKGROUND: Multiple long-term conditions are rising across all groups but people experiencing socioeconomic deprivation are found to have a higher prevalence. Self-management strategies are a vital part of healthcare for people with long-term conditions and effective strategies are associated with improved health outcomes in a variety of health conditions. The management of multiple long-term conditions are, however, less effective in people experiencing socioeconomic deprivation, leaving them more at risk of health inequalities. The purpose of this review is to identify and synthesise qualitative evidence on the barriers and facilitators of self-management on long-term conditions in those experiencing socioeconomic deprivation. METHODS: MEDLINE, EMBASE, AMED, PsycINFO and CINAHL Plus were searched for qualitative studies concerning self-management of multiple long-term conditions among socioeconomically disadvantaged populations. Data were coded and thematically synthesised using NVivo. FINDINGS: From the search results, 79 relevant qualitative studies were identified after the full text screening and 11 studies were included in the final thematic synthesis. Three overarching analytical themes were identified alongside a set of sub-themes: (1) Challenges of having multiple long-term conditions; prioritisation of conditions, impact of multiple long-term conditions on mental health and wellbeing, polypharmacy, (2) Socioeconomic barriers to self-management; financial, health literacy, compounding impact of multiple long-term conditions and socioeconomic deprivation, (3) Facilitators of self-management in people experiencing socioeconomic deprivation; maintaining independence, 'meaningful' activities, support networks. DISCUSSION: Self-management of multiple long-term conditions is challenging for people experiencing socioeconomic deprivation due to barriers around financial constraints and health literacy, which can lead to poor mental health and wellbeing. To support targeted interventions, greater awareness is needed among health professionals of the barriers/challenges of self-management among these populations.

Understanding ethnic inequalities in mental healthcare in the UK: A meta-ethnography.

BACKGROUND: Evidence regarding the presence and persistence of ethnic inequalities in mental healthcare is well established. The reasons for these inequalities and lack of progress in diminishing them are less understood. This meta-ethnography aims to provide a new conceptual understanding of how ethnic inequalities are created and sustained; this is essential to develop effective interventions. Specifically, we sought to understand why people from ethnic minority groups are underrepresented in primary care mental health service provision and overrepresented in crisis pathways and detention. METHODS AND FINDINGS: Following eMERGe guidelines for meta-ethnographies, we searched OpenGrey, Kings Fund, CINAHL, Medline, PsycINFO, and Social Care Online databases for qualitative articles published from database inception until October 2, 2022, using broad categories of search terms relating to "ethnicity AND (mental illness/mental health/emotional distress) AND (help-seeking/service utilisation/experience/perception/view)." We included all conceptually rich articles that used qualitative methods of data collection and analysis and excluded non-UK studies and those that focused solely on causation of mental illness. Our patient, public, and practitioner lived experience advisory group provided feedback and input on key stages of the project including search terms, research questions, data analysis, and dissemination. A total of 14,142 articles were identified; 66 met the inclusion criteria. We used reciprocal, refutational, and line of argument analytical approaches to identify convergence and divergence between studies. The synthesis showed that current models of statutory mental healthcare are experienced as a major barrier to the delivery of person-centred care to those in ethnic minority groups due to the perceived dominance of monocultural and reductionist frameworks of assessment and treatment (described as "medical" and "Eurocentric") and direct experiences of racist practice. The lack of socially oriented and holistic frameworks of knowledge and understanding in medical training and services is experienced as epistemic injustice, particularly among those who attribute their mental illness to experiences of migration, systemic racism, and complex trauma. Fear of harm, concerns about treatment suitability, and negative experiences with health providers such as racist care and medical neglect/injury contribute to avoidance of, and disengagement from, mainstream healthcare. The lack of progress in tackling ethnic inequalities is attributed to failures in coproduction and insufficient adoption of existing recommendations within services. Study limitations include insufficient recording of participant characteristics relating to generational status and social class in primary studies, which prevented exploration of these intersections. CONCLUSIONS: In this study, we found that the delivery of safe and equitable person-centred care requires a model of mental health that is responsive to the lived experiences of people in ethnic minority groups. For the people considered in this review, this requires better alignment of mental health services with social and anti-racist models of care. Our findings suggest that intersections related to experiences of racism, migration, religion, and complex trauma might be more relevant than crude ethnic group classifications. Strategies to tackle ethnic inequalities in mental healthcare require an evaluation of individual, systemic, and structural obstacles to authentic and meaningful coproduction and implementation of existing community recommendations in services.

Behavioural Activation for Social IsoLation (BASIL+) trial (Behavioural activation to mitigate depression and loneliness among older people with long-term conditions): Protocol for a fully-powered pragmatic randomised controlled trial.

INTRODUCTION: Depression is a leading mental health problem worldwide. People with long-term conditions are at increased risk of experiencing depression. The COVID-19 pandemic led to strict social restrictions being imposed across the UK population. Social isolation can have negative consequences on the physical and mental wellbeing of older adults. In the Behavioural Activation in Social IsoLation (BASIL+) trial we will test whether a brief psychological intervention (based on Behavioural Activation), delivered remotely, can mitigate depression and loneliness in older adults with long-term conditions during isolation. METHODS: We will conduct a two-arm, parallel-group, randomised controlled trial across several research sites, to evaluate the clinical and cost-effectiveness of the BASIL+ intervention. Participants will be recruited via participating general practices across England and Wales. Participants must be aged ≥65 with two or more long-term conditions, or a condition that may indicate they are within a 'clinically extremely vulnerable' group in relation to COVID-19, and have scored ≥5 on the Patient Health Questionnaire (PHQ9), to be eligible for inclusion. Randomisation will be 1:1, stratified by research site. Intervention participants will receive up to eight intervention sessions delivered remotely by trained BASIL+ Support Workers and supported by a self-help booklet. Control participants will receive usual care, with additional signposting to reputable sources of self-help and information, including advice on keeping mentally and physically well. A qualitative process evaluation will also be undertaken to explore the acceptability of the BASIL+ intervention, as well as barriers and enablers to integrating the intervention into participants' existing health and care support, and the impact of the intervention on participants' mood and general wellbeing in the context of the COVID-19 restrictions. Semi-structured interviews will be conducted with intervention participants, participant's caregivers/supportive others and BASIL+ Support Workers. Outcome data will be collected at one, three, and 12 months post-randomisation. Clinical and cost-effectiveness will be evaluated. The primary outcome is depressive symptoms at the three-month follow up, measured by the PHQ9. Secondary outcomes include loneliness, social isolation, anxiety, quality of life, and a bespoke health services use questionnaire. DISCUSSION: This study is the first large-scale trial evaluating a brief Behavioural Activation intervention in this population, and builds upon the results of a successful external pilot trial. TRIAL REGISTRATION: ClinicalTrials.Gov identifier ISRCTN63034289, registered on 5th February 2021.

Emotional distress, anxiety, and depression in South Asians with long-term conditions: a qualitative systematic review.

BACKGROUND: People with physical-mental comorbidity have a poorer quality of life, worse clinical outcomes, and increased mortality compared with people with physical conditions alone. People of South Asian (SA) origin are the largest minority group in the UK and are more likely to have long-term conditions (LTCs) such as diabetes and heart disease. People of SA origin are less likely to recognise symptoms that may represent mental health problems. AIM: To explore how people of SA origin with LTCs understand, experience, and seek help for emotional distress, depression, and anxiety. DESIGN AND SETTING: Systematic review of qualitative studies exploring emotional distress in people of SA origin with diabetes or coronary heart disease, within primary and community care settings worldwide. METHOD: Comprehensive searches of eight electronic databases from inception to 1 September 2021 were undertaken. Data extracted included study characteristics, and understanding, experience, and help-seeking behaviour for emotional distress. Thematic synthesis was undertaken. The Critical Appraisal Skills Programme (CASP) checklist for qualitative studies was used to assess quality of articles, and Confidence in the Evidence from Reviews of Qualitative Research (GRADE-CERQual) used to determine the overall strength of evidence. RESULTS: Twenty-one studies from 3165 unique citations were included. Three main themes were identified. Understanding of emotional distress: non-medical terminology used, such as 'tension', and a complex relationship between emotional and physical illness. Experiences of emotional distress: multiple forms of inequality, distress at diagnosis of their LTC, cultural factors, and sex differences. Help-seeking behaviour: self-management, support from family, friends, and faith, and inadequate clinical support. CONCLUSION: This review provides a greater understanding of the conceptualisation of emotional distress in the context of LTCs by people of SA origin, to support improvement in its recognition and management.

Can We Prevent Depression in At-Risk Older Adults Using Self-Help? The UK SHARD Trial of Behavioral Activation.

BACKGROUND: Treatment of established depression is the dominant approach to care of older adults, but prevention holds much promise. Self-help interventions are a feasible preventive approach, since they are scalable and low cost. There are few trials in this area. Behavioral Activation (BA) is a credible candidate psychological approach, which has been shown to work in therapist led care but not been trialled in a self-help form. AIM: To test the effectiveness of an unguided self-help intervention based on BA for older adults. METHODS: We compared a self-help intervention based on BA for older people (n = 172) to usual care (n = 160) in a pragmatic randomized controlled trial. Outcomes were depression status and severity (PHQ9) and health related quality of life (SF12). The primary timepoint of the primary outcome was depression at 4 months, with longer term follow up at 12 months to test sustained impact of the primary outcome. RESULTS: At 4 months adjusted PHQ-9 scores for BA self-help were 0.79 lower (95% CI: -1.70 to 0.13; p = 0.09) and the proportion of participants with case-level depression was significantly reduced (BA 31/137 (22.6%) versus usual care 41/141 (29.1%); Odds Ratio 0.48; 95% CI: 0.26-0.92; p = 0.03). There was no PHQ-9 difference at 12 months or for health related quality of life at any point (4 or 12 months). DISCUSSION: Self-help using BA for older people at risk of depression is a feasible and scalable intervention with potential short-term benefits in preventing depression.

Community Ageing Research 75+ (CARE75+) REMOTE study: a remote model of recruitment and assessment of the health, well-being and social circumstances of older people.

INTRODUCTION: The Community Ageing Research 75+ (CARE75+) study is a longitudinal cohort study collecting extensive health and social data, with a focus on frailty, independence and quality of life in older age. CARE75+ was the first international experimental frailty research cohort designed using trial within cohorts (TwiCs) methodology, aligning epidemiological research with clinical trial evaluation of interventions to improve the health and well-being of older people. CARE75+ REMOTE is an extension of CARE75+ using a remote model that does not require face-to-face interactions for data collection in the current circumstances of a global pandemic and will provide an efficient, sustainable data collection model. METHODS AND ANALYSIS: Prospective cohort study using TwiCs. One thousand community-dwelling older people (≥75 years) will be recruited from UK general practices by telephone. Exclusions include: nursing home/care home residents; those with an estimated life expectancy of 3 months or less; and people receiving palliative care. DATA COLLECTION: Assessments will be conducted by telephone, web-submission or postal questionnaire: baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months. Measures include activities of daily living, mood, health-related quality of life, comorbidities, medications, frailty, informal care, healthcare and social care service use. Consent will be sought for data linkage and invitations to additional studies (sub-studies). ETHICS AND DISSEMINATION: CARE75+ was approved by the National Research Ethics Service (NRES) Committee Yorkshire and the Humber-Bradford Leeds 10 October 2014 (14/YH/1120). CARE75+ REMOTE (amendment 13) was approved on the 18th November 2020. Consent is sought if an individual is willing to participate and has capacity to provide informed consent. Consultee assent is sought if an individual lacks capacity. Results will be disseminated in peer-reviewed scientific journals and conferences. Results will be summarised and disseminated to study participants via newsletters, local engagement events and on a bespoke website. TRIAL REGISTRATION NUMBER: ISRCTN16588124.

Behavioural activation to prevent depression and loneliness among socially isolated older people with long-term conditions: The BASIL COVID-19 pilot randomised controlled trial.

BACKGROUND: Older adults, including those with long-term conditions (LTCs), are vulnerable to social isolation. They are likely to have become more socially isolated during the Coronavirus Disease 2019 (COVID-19) pandemic, often due to advice to "shield" to protect them from infection. This places them at particular risk of depression and loneliness. There is a need for brief scalable psychosocial interventions to mitigate the psychological impacts of social isolation. Behavioural activation (BA) is a credible candidate intervention, but a trial is needed. METHODS AND FINDINGS: We undertook an external pilot parallel randomised trial (ISRCTN94091479) designed to test recruitment, retention and engagement with, and the acceptability and preliminary effects of the intervention. Participants aged ≥65 years with 2 or more LTCs were recruited in primary care and randomised by computer and with concealed allocation between June and October 2020. BA was offered to intervention participants (n = 47), and control participants received usual primary care (n = 49). Assessment of outcome was made blind to treatment allocation. The primary outcome was depression severity (measured using the Patient Health Questionnaire 9 (PHQ-9)). We also measured health-related quality of life (measured by the Short Form (SF)-12v2 mental component scale (MCS) and physical component scale (PCS)), anxiety (measured by the Generalised Anxiety Disorder 7 (GAD-7)), perceived social and emotional loneliness (measured by the De Jong Gierveld Scale: 11-item loneliness scale). Outcome was measured at 1 and 3 months. The mean age of participants was aged 74 years (standard deviation (SD) 5.5) and they were mostly White (n = 92, 95.8%), and approximately two-thirds of the sample were female (n = 59, 61.5%). Remote recruitment was possible, and 45/47 (95.7%) randomised to the intervention completed 1 or more sessions (median 6 sessions) out of 8. A total of 90 (93.8%) completed the 1-month follow-up, and 86 (89.6%) completed the 3-month follow-up, with similar rates for control (1 month: 45/49 and 3 months 44/49) and intervention (1 month: 45/47and 3 months: 42/47) follow-up. Between-group comparisons were made using a confidence interval (CI) approach, and by adjusting for the covariate of interest at baseline. At 1 month (the primary clinical outcome point), the median number of completed sessions for people receiving the BA intervention was 3, and almost all participants were still receiving the BA intervention. The between-group comparison for the primary clinical outcome at 1 month was an adjusted between-group mean difference of -0.50 PHQ-9 points (95% CI -2.01 to 1.01), but only a small number of participants had completed the intervention at this point. At 3 months, the PHQ-9 adjusted mean difference (AMD) was 0.19 (95% CI -1.36 to 1.75). When we examined loneliness, the adjusted between-group difference in the De Jong Gierveld Loneliness Scale at 1 month was 0.28 (95% CI -0.51 to 1.06) and at 3 months -0.87 (95% CI -1.56 to -0.18), suggesting evidence of benefit of the intervention at this time point. For anxiety, the GAD adjusted between-group difference at 1 month was 0.20 (-1.33, 1.73) and at 3 months 0.31 (-1.08, 1.70). For the SF-12 (physical component score), the adjusted between-group difference at 1 month was 0.34 (-4.17, 4.85) and at 3 months 0.11 (-4.46, 4.67). For the SF-12 (mental component score), the adjusted between-group difference at 1 month was 1.91 (-2.64, 5.15) and at 3 months 1.26 (-2.64, 5.15). Participants who withdrew had minimal depressive symptoms at entry. There were no adverse events. The Behavioural Activation in Social Isolation (BASIL) study had 2 main limitations. First, we found that the intervention was still being delivered at the prespecified primary outcome point, and this fed into the design of the main trial where a primary outcome of 3 months is now collected. Second, this was a pilot trial and was not designed to test between-group differences with high levels of statistical power. Type 2 errors are likely to have occurred, and a larger trial is now underway to test for robust effects and replicate signals of effectiveness in important secondary outcomes such as loneliness. CONCLUSIONS: In this study, we observed that BA is a credible intervention to mitigate the psychological impacts of COVID-19 isolation for older adults. We demonstrated that it is feasible to undertake a trial of BA. The intervention can be delivered remotely and at scale, but should be reserved for older adults with evidence of depressive symptoms. The significant reduction in loneliness is unlikely to be a chance finding, and replication will be explored in a fully powered randomised controlled trial (RCT). TRIAL REGISTRATION: ISRCTN94091479.

The challenge of pain identification, assessment, and management in people with dementia: a qualitative study.

BACKGROUND: Painful conditions are common in older adults, including people with dementia. The symptoms associated with dementia (for example, diminished language capacity, memory impairment, and behavioural changes), however, may lead to the suboptimal identification, assessment, and management of pain. Research has yet to qualitatively explore pain management for community-dwelling people with dementia. AIM: To explore pain identification, assessment, and management for community-dwelling people with dementia. DESIGN & SETTING: A qualitative study was undertaken, set in England. METHOD: Semi-structured interviews took place with people with dementia, family caregivers, GPs, and old-age psychiatrists. Data were analysed thematically. RESULTS: Interviews were conducted with eight people with dementia, nine family caregivers, nine GPs, and five old-age psychiatrists. Three themes were identified that related to pain identification and assessment: gathering information to identify pain; the importance of knowing the person; and the use of pain assessment tools. A further three themes were identified that related to pain management: non-drug strategies; concerns related to analgesic medications; and responsibility of the caregiver to manage pain. CONCLUSION: Identifying and assessing the pain experienced by people with dementia was challenging. Most people with dementia, family caregivers, and healthcare professionals supported non-drug strategies to manage pain. The minimal concerns associated with non-drug strategies contrasted the multifactorial concerns associated with analgesic treatment for people with dementia. Given the complexity of pain identification, assessment, and management, primary care should work together with family caregivers and community services, with case finding for pain being considered in all assessment and management plans.

Temporal Changes in Hypertensive Disorders of Pregnancy and Impact on Cardiovascular and Obstetric Outcomes.

Hypertensive disorders of pregnancy (HDP) are a major cause of maternal morbidity. However, short-term outcomes of HDP subgroups remain unknown. Using National Inpatient Sample database, all delivery hospitalizations between 2004 and 2014 with or without HDP (preeclampsia/eclampsia, chronic hypertension, superimposed preeclampsia on chronic hypertension, and gestational hypertension) were analyzed to examine the association between HDP and adverse in-hospital outcomes. We identified >44 million delivery hospitalizations, within which the prevalence of HDP increased from 8% to 11% over a decade with increasing comorbidity burden. Women with chronic hypertension have higher risks of myocardial infarction, peripartum cardiomyopathy, arrhythmia, and stillbirth compared to women with preeclampsia. Out of all HDP subgroups, the superimposed preeclampsia population had the highest risk of stroke (odds ratio [OR] 7.83, 95% confidence interval [CI] 6.25 to 9.80), myocardial infarction (OR 5.20, 95% CI 3.11 to 8.69), peripartum cardiomyopathy (OR 4.37, 95% CI 3.64 to 5.26), preterm birth (OR 4.65, 95% CI 4.48 to 4.83), placental abruption (OR 2.22, 95% CI 2.09 to 2.36), and stillbirth (OR 1.78, 95% CI 1.66 to 1.92) compared to women without HDP. In conclusion, we are the first to evaluate chronic systemic hypertension without superimposed preeclampsia as a distinct subgroup in HDP and show that women with chronic systemic hypertension are at even higher risk of some adverse outcomes compared to women with preeclampsia. In conclusion, the chronic hypertension population, with and without superimposed preeclampsia, is a particularly high-risk group and may benefit from increased antenatal surveillance and the use of a prognostic risk assessment model incorporating HDP to stratify intrapartum care.

Pain assessment and pain treatment for community-dwelling people with dementia: A systematic review and narrative synthesis.

OBJECTIVES: To describe the current literature on pain assessment and pain treatment for community-dwelling people with dementia. METHOD: A comprehensive systematic search of the literature with narrative synthesis was conducted. Eight major bibliographic databases were searched in October 2018. Titles, abstracts, and full-text articles were sequentially screened. Standardised data extraction and quality appraisal exercises were conducted. RESULTS: Thirty-two studies were included in the review, 11 reporting findings on pain assessment tools or methods and 27 reporting findings on treatments for pain. In regard to pain assessment, a large proportion of people with moderate to severe dementia were unable to complete a self-report pain instrument. Pain was more commonly reported by informal caregivers than the person with dementia themselves. Limited evidence was available for pain-focused behavioural observation assessment. In regard to pain treatment, paracetamol use was more common in community-dwelling people with dementia compared with people without dementia. However, non-steroidal anti-inflammatory drugs (NSAIDs) were used less. For stronger analgesics, community-dwelling people with dementia were more likely to receive strong opioids (eg, fentanyl) than people without dementia. CONCLUSION: This review identifies a dearth of high-quality studies exploring pain assessment and/or treatment for community-dwelling people with dementia, not least into non-pharmacological interventions. The consequences of this lack of evidence, given the current and projected prevalence of the disease, are very serious and require urgent redress. In the meantime, clinicians should adopt a patient- and caregiver-centred, multi-dimensional, longitudinal approach to pain assessment and pain treatment for this population.

Combining mirtazapine with SSRIs or SNRIs for treatment-resistant depression: the MIR RCT.

BACKGROUND: Depression is usually managed in primary care and antidepressants are often the first-line treatment, but only half of those treated respond to a single antidepressant. OBJECTIVES: To investigate whether or not combining mirtazapine with serotonin-noradrenaline reuptake inhibitor (SNRI) or selective serotonin reuptake inhibitor (SSRI) antidepressants results in better patient outcomes and more efficient NHS care than SNRI or SSRI therapy alone in treatment-resistant depression (TRD). DESIGN: The MIR trial was a two-parallel-group, multicentre, pragmatic, placebo-controlled randomised trial with allocation at the level of the individual. SETTING: Participants were recruited from primary care in Bristol, Exeter, Hull/York and Manchester/Keele. PARTICIPANTS: Eligible participants were aged ≥ 18 years; were taking a SSRI or a SNRI antidepressant for at least 6 weeks at an adequate dose; scored ≥ 14 points on the Beck Depression Inventory-II (BDI-II); were adherent to medication; and met the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, criteria for depression. INTERVENTIONS: Participants were randomised using a computer-generated code to either oral mirtazapine or a matched placebo, starting at a dose of 15 mg daily for 2 weeks and increasing to 30 mg daily for up to 12 months, in addition to their usual antidepressant. Participants, their general practitioners (GPs) and the research team were blind to the allocation. MAIN OUTCOME MEASURES: The primary outcome was depression symptoms at 12 weeks post randomisation compared with baseline, measured as a continuous variable using the BDI-II. Secondary outcomes (at 12, 24 and 52 weeks) included response, remission of depression, change in anxiety symptoms, adverse events (AEs), quality of life, adherence to medication, health and social care use and cost-effectiveness. Outcomes were analysed on an intention-to-treat basis. A qualitative study explored patients' views and experiences of managing depression and GPs' views on prescribing a second antidepressant. RESULTS: There were 480 patients randomised to the trial (mirtazapine and usual care, n = 241; placebo and usual care, n = 239), of whom 431 patients (89.8%) were followed up at 12 weeks. BDI-II scores at 12 weeks were lower in the mirtazapine group than the placebo group after adjustment for baseline BDI-II score and minimisation and stratification variables [difference -1.83 points, 95% confidence interval (CI) -3.92 to 0.27 points; p = 0.087]. This was smaller than the minimum clinically important difference and the CI included the null. The difference became smaller at subsequent time points (24 weeks: -0.85 points, 95% CI -3.12 to 1.43 points; 12 months: 0.17 points, 95% CI -2.13 to 2.46 points). More participants in the mirtazapine group withdrew from the trial medication, citing mild AEs (46 vs. 9 participants). CONCLUSIONS: This study did not find convincing evidence of a clinically important benefit for mirtazapine in addition to a SSRI or a SNRI antidepressant over placebo in primary care patients with TRD. There was no evidence that the addition of mirtazapine was a cost-effective use of NHS resources. GPs and patients were concerned about adding an additional antidepressant. LIMITATIONS: Voluntary unblinding for participants after the primary outcome at 12 weeks made interpretation of longer-term outcomes more difficult. FUTURE WORK: Treatment-resistant depression remains an area of important, unmet need, with limited evidence of effective treatments. Promising interventions include augmentation with atypical antipsychotics and treatment using transcranial magnetic stimulation. TRIAL REGISTRATION: Current Controlled Trials ISRCTN06653773; EudraCT number 2012-000090-23. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 63. See the NIHR Journals Library website for further project information.

Self-harm in a primary care cohort of older people: incidence, clinical management, and risk of suicide and other causes of death.

BACKGROUND: Self-harm is a major risk factor for suicide, with older adults (older than 65 years) having reportedly greater suicidal intent than any other age group. With the aging population rising and paucity of research focus in this age group, the extent of the problem of self-harm needs to be established. In a primary care cohort of older adults we aimed to investigate the incidence of self-harm, subsequent clinical management, prevalence of mental and physical diagnoses, and unnatural-cause mortality risk, including suicide. METHODS: The UK Clinical Practice Research Datalink contains anonymised patient records from general practice that routinely capture clinical information pertaining to both primary and secondary care services. We identified 4124 adults aged 65 years and older with a self-harm episode ascertained from Read codes recorded during 2001-14. We calculated standardised incidence and in 2854 adults with at least 12 months follow-up examined the frequency of psychiatric referrals and prescription of psychotropic medication after self-harm. We estimated prevalence of mental and physical illness diagnoses before and after self-harm and, using Cox regression in a matched cohort, we examined cause-specific mortality risks. FINDINGS: Overall incidence of self-harm in older adults aged 65 years and older was 4·1 per 10 000 person-years with stable gender-specific rates observed over the 13-year period. After self-harm, 335 (11·7%) of 2854 adults were referred to mental health services, 1692 (59·3%) were prescribed an antidepressant, and 336 (11·8%) were prescribed a tricyclic antidepressant (TCA). Having a diagnosed previous mental illness was twice as prevalent in the self-harm cohort as in the comparison cohort (prevalence ratio 2·10 [95% CI 2·03-2·17]) and with a previous physical health condition prevalence was 20% higher in the self-harm cohort compared to the comparison cohort (1·20 [1·17-1·23]). Adults from the self-harm cohort (n=2454) died from unnatural causes an estimated 20 times more frequently than the comparison cohort (n=48 921) during the first year. A markedly elevated risk of suicide (hazard ratio 145·4 [95% CI 53·9-392·3]) was observed in the self-harm cohort. INTERPRETATION: Within primary care, we have identified a group of older adults at high risk from unnatural death, particularly within the first year of self-harm. We have highlighted a high frequency of prescription of TCAs, known to be potentially fatally toxic in overdose. We emphasise the need for early intervention, careful alternative prescribing, and increased support when older adults consult after an episode of self-harm and with other health conditions. FUNDING: National Institute for Health Research Greater Manchester Patient Safety Translational Research Centre.

Long-term clinical and cost-effectiveness of collaborative care (versus usual care) for people with mental-physical multimorbidity: cluster-randomised trial.

BACKGROUND: Collaborative care can support the treatment of depression in people with long-term conditions, but long-term benefits and costs are unknown.AimsTo explore the long-term (24-month) effectiveness and cost-effectiveness of collaborative care in people with mental-physical multimorbidity. METHOD: A cluster randomised trial compared collaborative care (integrated physical and mental healthcare) with usual care for depression alongside diabetes and/or coronary heart disease. Depression symptoms were measured by the symptom checklist-depression scale (SCL-D13). The economic evaluation was from the perspective of the English National Health Service. RESULTS: 191 participants were allocated to collaborative care and 196 to usual care. At 24 months, the mean SCL-D13 score was 0.27 (95% CI, -0.48 to -0.06) lower in the collaborative care group alongside a gain of 0.14 (95% CI, 0.06-0.21) quality-adjusted life-years (QALYs). The cost per QALY gained was £13 069. CONCLUSIONS: In the long term, collaborative care reduces depression and is potentially cost-effective at internationally accepted willingness-to-pay thresholds.Declaration of interestNone.

Cost-Utility Analysis of Routine Anxiety and Depression Screening in Patients Consulting for Osteoarthritis: Results From a Clinical, Randomized Controlled Trial.

OBJECTIVE: To investigate the cost-effectiveness (cost-utility) of introducing general practitioner screening for anxiety and depression in patients consulting for osteoarthritis (OA). METHODS: A cluster-randomized trial-based economic evaluation to assess general practitioners screening for anxiety and depression symptoms in patients consulting for OA compared to usual care (screening for pain intensity) was undertaken over a 12-month period from a UK National Health Service and societal perspective. Patient-level mean costs and mean quality-adjusted life years (QALYs) were estimated, and cost-effectiveness acceptability curves controlling for cluster-level data were constructed. The base-case analysis used the net benefit regressions approach. The 2-stage nonparametric sampling technique was explored in a sensitivity analysis. RESULTS: The base-case analysis demonstrated that the intervention was as costly as, and less effective than, the control (QALY differential -0.029 [95% confidence interval -0.062, 0.003]). In the base-case analyses, general practitioner screening for anxiety and depression was unlikely to be a cost-effective option (probability <5% at £20,000/QALY). Similar results were observed in all sensitivity analyses. CONCLUSION: Prompting general practitioners to routinely screen and manage comorbid anxiety and depression in patients presenting with OA is unlikely to be cost-effective. Further research is needed to explore clinically effective and cost-effective models of managing anxiety and depression in patients presenting with clinical OA.

CollAborative care for Screen-Positive EldeRs with major depression (CASPER plus): a multicentred randomised controlled trial of clinical effectiveness and cost-effectiveness.

BACKGROUND: Depression in older adults is common and is associated with poor quality of life, increased morbidity and early mortality, and increased health and social care use. Collaborative care, a low-intensity intervention for depression that is shown to be effective in working-age adults, has not yet been evaluated in older people with depression who are managed in UK primary care. The CollAborative care for Screen-Positive EldeRs (CASPER) plus trial fills the evidence gap identified by the most recent guidelines on depression management. OBJECTIVES: To establish the clinical effectiveness and cost-effectiveness of collaborative care for older adults with major depressive disorder in primary care. DESIGN: A pragmatic, multicentred, two-arm, parallel, individually randomised controlled trial with embedded qualitative study. Participants were automatically randomised by computer, by the York Trials Unit Randomisation Service, on a 1 : 1 basis using simple unstratified randomisation after informed consent and baseline measures were collected. Blinding was not possible. SETTING: Sixty-nine general practices in the north of England. PARTICIPANTS: A total of 485 participants aged ≥ 65 years with major depressive disorder. INTERVENTIONS: A low-intensity intervention of collaborative care, including behavioural activation, delivered by a case manager for an average of six sessions over 7-8 weeks, alongside usual general practitioner (GP) care. The control arm received only usual GP care. MAIN OUTCOME MEASURES: The primary outcome measure was Patient Health Questionnaire-9 items score at 4 months post randomisation. Secondary outcome measures included depression severity and caseness at 12 and 18 months, the EuroQol-5 Dimensions, Short Form questionnaire-12 items, Patient Health Questionnaire-15 items, Generalised Anxiety Disorder-7 items, Connor-Davidson Resilience Scale-2 items, a medication questionnaire, objective data and adverse events. Participants were followed up at 12 and 18 months. RESULTS: In total, 485 participants were randomised (collaborative care, n = 249; usual care, n = 236), with 390 participants (80%: collaborative care, 75%; usual care, 86%) followed up at 4 months, 358 participants (74%: collaborative care, 70%; usual care, 78%) followed up at 12 months and 344 participants (71%: collaborative care, 67%; usual care, 75%) followed up at 18 months. A total of 415 participants were included in primary analysis (collaborative care, n = 198; usual care, n = 217), which revealed a statistically significant effect in favour of collaborative care at the primary end point at 4 months [8.98 vs. 10.90 score points, mean difference 1.92 score points, 95% confidence interval (CI) 0.85 to 2.99 score points; p < 0.001], equivalent to a standard effect size of 0.34. However, treatment differences were not maintained in the longer term (at 12 months: 0.19 score points, 95% CI -0.92 to 1.29 score points; p = 0.741; at 18 months: < 0.01 score points, 95% CI -1.12 to 1.12 score points; p = 0.997). The study recorded details of all serious adverse events (SAEs), which consisted of 'unscheduled hospitalisation', 'other medically important condition' and 'death'. No SAEs were related to the intervention. Collaborative care showed a small but non-significant increase in quality-adjusted life-years (QALYs) over the 18-month period, with a higher cost. Overall, the mean cost per incremental QALY for collaborative care compared with usual care was £26,016; however, for participants attending six or more sessions, collaborative care appears to represent better value for money (£9876/QALY). LIMITATIONS: Study limitations are identified at different stages: design (blinding unfeasible, potential contamination), process (relatively low overall consent rate, differential attrition/retention rates) and analysis (no baseline health-care resource cost or secondary/social care data). CONCLUSION: Collaborative care was effective for older people with case-level depression across a range of outcomes in the short term though the reduction in depression severity was not maintained over the longer term of 12 or 18 months. Participants who received six or more sessions of collaborative care did benefit substantially more than those who received fewer treatment sessions but this difference was not statistically significant. FUTURE WORK RECOMMENDATIONS: Recommendations for future research include investigating the longer-term effect of the intervention. Depression is a recurrent disorder and it would be useful to assess its impact on relapse and the prevention of future case-level depression. TRIAL REGISTRATION: Current Controlled Trials ISRCTN45842879. 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. 21, No. 67. See the NIHR Journals Library website for further project information.