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Impact of electronic palliative care coordination systems (EPaCCS) on care at the end of life across multiple care sectors, in one clinical commissioning group area, in England: a realist evaluation protocol
Introduction: Electronic palliative care coordination systems (EPaCCS) aim to support people approaching the end of life (EOL) to receive consistent care, according to their wishes, that is coordinated effectively across multiple care sectors. They are in use across the UK although empirical evidence into their effectiveness is poor. This paper presents a protocol of a mixed-methods study, to understand how, and by whom, EPaCCS are being used and whether EPaCCS are enabling Healthcare Professionals (HCPs) to coordinate patients’ EOL care. Methods and analysis: This is a mixed-methods study, carried out within a realist paradigm, to evaluate the impact of an EPaCCS on EOL care as provided by a Clinical Commissioning Group (CCG) in England. This study has two aims: (1) Describe the socio-demographic characteristics of patients who die with an EPaCCS record, their underlying cause of death and place of death and compare these with patients who die without an EPaCCS record. (2) Explore the impact of an EPaCCS on the experience of receiving EOL care for patients and their carers, and understand HCPs’ views and experiences of utilising an EPaCCS to coordinate care for their patients. The study will be conducted in five phases: (1) development of the initial programme theory; (2) focus group with CCG stakeholder board; (3) individual interviews with HCPs, patients, current and bereaved carers; (4) retrospective cohort study of routinely collected data on EPaCCS usage and (5) data analysis and synthesis of study findings. Ethics and dissemination: The study has been approved by National Health Service South West–Frenchay Research Ethics Committee (REC reference number: 18/SW/0198). Findings will be published in a wide range of outputs targeted at key audiences.
Non-pharmacological interventions for depression/anxiety in older adults with physical comorbidities affecting functioning: systematic review and meta-analysis
Objective: To review the effectiveness of non-pharmacological interventions in older adults with depression or anxiety and comorbidities affecting functioning. Design: Systematic review and meta-analysis of randomized controlled trials, including searches of 10 databases (inception-Jul 2017). Setting: Home/community. Participants: People aged 60 and over experiencing functional difficulties from physical or cognitive comorbidities and have symptoms or a diagnosis of depression and/or anxiety. Interventions: Non-pharmacological interventions targeted at depression/anxiety. Measurements: We extracted outcome data on depressive symptoms, quality of life, functioning, and service use. We used random effects meta-analysis to pool study data where possible. Two authors assessed the risk of bias using the Cochrane Risk of Bias tool. Results: We identified 14 eligible trials including 2099 randomized participants and two subgroup analyses. Problem-solving therapy (PST) reduced short-term clinician-rated depressive symptoms (n = 5 trials, mean difference in Hamilton Depression Rating Scale score −4.94 [95% CI −7.90 to −1.98]) but not remission, with limited evidence for effects on functioning and quality of life. There was limited high-quality evidence for other intervention types. Collaborative care did not appear to affect depressive symptoms, functioning, or quality of life; and had mixed evidence for effects upon remission. No intervention consistently affected service use, but trials were limited by small sample sizes and short follow-up periods. No anxiety interventions were identified. Conclusion: PST may reduce depressive symptoms post-intervention in older people with depression and functional impairments. Collaborative care appears to have few effects in this population. Future research needs to assess cost-effectiveness, long-term outcomes, and anxiety interventions for this population.
Crossing the Digital Divide in Online Self-Management Support: Analysis of Usage Data From HeLP-Diabetes
Background: Digital health is increasingly recognized as a cost-effective means to support patient self-care. However, there are concerns about whether the “digital divide,” defined as the gap between those who do and do not make regular use of digital technologies, will lead to increased health inequalities. Access to the internet, computer literacy, motivation to use digital health interventions, and fears about internet security are barriers to use of digital health interventions. Some of these barriers disproportionately affect people of older age, black or minority ethnic background, and low socioeconomic status. HeLP-Diabetes (Healthy Living for People with type 2 Diabetes), a theoretically informed online self-management program for adults with type 2 diabetes, was developed to meet the needs of people from a broad demographic background. Objective: This study aimed to determine whether there was evidence of a digital divide when HeLP-Diabetes was integrated into routine care. This was achieved by (1) comparing the characteristics of people who registered for the program against the target population (people with type 2 diabetes in inner London), (2) comparing the characteristics of people who registered for the program and used it with those who did not use it, and (3) comparing sections of the website visited by different demographic groups. Methods: A retrospective analysis of data on the use of HeLP-Diabetes in routine clinical practice in 4 inner London clinical commissioning groups was undertaken. Data were collected from patients who registered for the program as part of routine health services.. Data on gender, age, ethnicity, and educational attainment were collected at registration, and data on webpage visits (user identification number, date, time, and page visited) were collected automatically by software on the server side of the website. Results: The characteristics of people who registered for the program were found to reflect those of the target population. The mean age was 58.4 years (SD=28.0), over 50.0% were from black and minority ethnic backgrounds, and nearly a third (29.8%) had no qualifications beyond school leaving age. There was no association between demographic characteristics and use of the program, apart from weak evidence of less use by the mixed ethnicity group. There was no evidence of the differential use of the program by any demographic group, apart from weak evidence for people with degrees and school leavers being more likely to use the “Living and working with diabetes” (P=.03) and “Treating diabetes” (P=.04) sections of the website. Conclusions: This study is one of the first to provide evidence that a digital health intervention can be integrated into routine health services without widening health inequalities. The relative success of the intervention may be attributed to integration into routine health care, and careful design with extensive user input and consideration of literacy levels. Developers of digital health interventions need to acknowledge barriers to access and use, and collect data on the demographic profile of users, to address inequalities.
Heart failure disease management: a systematic review of effectiveness in heart failure with preserved ejection fraction
Aims Heart failure with preserved ejection fraction (HFpEF) poses a substantial challenge for clinicians, but there is little guidance for effective management. The aim of this systematic review was to determine if there was evidence that disease management programmes (DMPs) improved outcomes for patients with HFpEF. Methods and results A systematic review of controlled studies in English or Greek of DMPs including patients with HFpEF from 2008 to 2018 was conducted using CINAHL, Cochrane, MEDLINE, and Embase. Interventions were assessed using a DMP taxonomy and scored for complexity and intensity. Bias was assessed using the Cochrane Collaboration tool. Initial and updated searches found 6089 titles once duplicates were removed. The final analysis included 18 studies with 5435 HF patients: 1866 patients (34%, study ranges 18–100%) had potential HFpEF (limited by variable definitions). Significant heterogeneity in terms of the population, intervention, comparisons, and outcomes prohibited meta‐analysis. Statistically significant or positive trends were found in mortality, hospitalization rates, self‐care ability, quality of life, anxiety, depression, and sleep, but findings were not robust or consistent. Four studies reported results separately for study‐defined HFpEF, with two finding less positive effect on outcomes. Conclusions Varying definitions of HFpEF used in studies are a substantial limitation in interpretation of findings. The reduced efficacy noted in contemporary HF DMP studies may not only be due to improvements in usual care but may also reflect inclusion of heterogeneous patients with HFpEF or HF with mid‐range EF who may not respond in the same way as HFrEF to individual components. Given that patients with HFpEF are older and multi‐morbid, DMPs targeting HFpEF should not rely on a single‐disease focus but provide care that addresses predisposing and presentation phenotypes and draws on the principles of comprehensive geriatric assessment. Other components could also be more targeted to HFpEF such as modification of lifestyle factors for which there is emerging evidence, rather than simply continuing the model of care used in HFrEF. Based on current evidence, HF DMPs may improve mortality, hospitalization rates, self‐care, and quality of life in patients with HFpEF; however, further research specifically tailored to appropriately defined HFpEF is required.
Do comorbidities predict pain and function in knee osteoarthritis following an exercise intervention, and do they moderate the effect of exercise? Analyses of data from three randomized controlled trials
Background Although exercise is a core treatment for people with knee osteoarthritis (OA), it is currently unknown whether those with additional comorbidities respond differently to exercise than those without. We explored whether comorbidities predict pain and function following an exercise intervention in people with knee OA, and whether they moderate response to: exercise versus no exercise; and enhanced exercise versus usual exercise‐based care. Methods We undertook analyses of existing data from three randomized controlled trials (RCTs): TOPIK (n = 217), APEX (n = 352) and Benefits of Effective Exercise for knee Pain (BEEP) (n = 514). All three RCTs included: adults with knee pain attributable to OA; physiotherapy‐led exercise; data on six comorbidities (overweight/obesity, pain elsewhere, anxiety/depression, cardiac problems, diabetes mellitus and respiratory conditions); the outcomes of interest (six‐month Western Ontario and McMaster Universities Arthritis Index knee pain and function). Adjusted mixed models were fitted where data was available; otherwise linear regression models were used. Results Obesity compared with underweight/normal body mass index was significantly associated with knee pain following exercise, as was the presence compared with absence of anxiety/depression. The presence of cardiac problems was significantly associated with the effect of enhanced versus usual exercise‐based care for knee function, indicating that enhanced exercise may be less effective for improving knee function in people with cardiac problems. Associations for all other potential prognostic factors and moderators were weak and not statistically significant. Conclusions Obesity and anxiety/depression predicted pain and function outcomes in people offered an exercise intervention, but only the presence of cardiac problems might moderate the effect of exercise for knee OA. Further confirmatory investigations are required.
Preventing depression in the community by voluntary sector providers (PERSUADE): intervention development and protocol for a parallel randomised controlled feasibility trial
Introduction Depression is now the most common illness worldwide affecting more than 300million people. Studies modelling the impact of depression interventions have shown that the burden of depression cannot be minimised by more than 35% with existing treatments. There is a need to develop better preventative interventions. The overall aim of this programme of work is to develop interventions to reduce depression symptom scores and prevent development of depression in people with subthreshold depression. The objectives are to adapt a low intensity community-based depression prevention intervention, establish the acceptability and uptake of this model and conduct a parallel randomised controlled feasibility trial to inform a full-scale trial. Methods and analysis Focus groups will be run with members of the public, voluntary sector providers and researchers to inform the adaptation of an existing depression prevention course. Sixty-four people with subthreshold depression, as represented by a score of between 5 and 9 on the Patient Health Questionnaire-9 depression measure, will be recruited to take part in the feasibility trial. Participants will be randomised equally to the intervention or usual care control groups. Participants in the intervention group will receive the new revised manual and attend a 1-day workshop delivered by voluntary sector service providers. Outcome measures will be completed 3months after baseline. Quantitative data on recruitment, randomisation, attendance, retention, questionnaire completion rates will be collected. Primary analyses will be descriptive and a process evaluation will be conducted to assess the processes involved in implementing the intervention. Interviews will be conducted to explore acceptability and framework analysis will be used to analyse the data. Ethics and dissemination The study has been reviewedand approved by NHS Research and Ethics Committee: NW-Greater Manchester East. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media, the internet and community engagement activities.
DIAMOND (DIgital Alcohol Management ON Demand): a feasibility RCT and embedded process evaluation of a digital health intervention to reduce hazardous and harmful alcohol use recruiting in hospital emergency departments and online
The harmful use of alcohol is a causal factor in more than 200 disease and injury conditions and leads to over 3 million deaths every year worldwide. Relatively few problem alcohol users access treatment due to stigma and lack of services. Alcohol-specific digital health interventions (DHI) may help them, but trial data comparing DHI with face-to-face treatment are lacking. Methods We conducted a feasibility RCT of an alcohol DHI, testing recruitment, online data-collection and randomisation processes, with an embedded process evaluation. Recruitment ran from October 2015 for 12 months. Participants were adults, drinking at hazardous and harmful levels, recruited from hospital emergency departments (ED) in London or recruited online. Participants were randomised to HeLP-Alcohol, a six module DHI with weekly reminder prompts (phone, email or text message), or to face-to-face treatment as usual (TAU). Participants were invited to take part in qualitative interviews after the trial. Results The trial website was accessed 1074 times: 420 people completed online eligibility questionnaires; 350 did not meet eligibility criteria, 51 declined to participate, and 19 were recruited and randomised. Follow-up data were collected from three participants (retention 3/19), and four agreed to be interviewed for the process evaluation. The main themes of the interviews were: Participants were not at equipoise. They wanted to try the website and were disappointed to be randomised to face-to-face, so they were less engaged and dropped out. Other reasons for drop out included not accepting that they had a drink problem; problem drinking interfering with their ability to take part in a trial or forgetting appointments; having a busy life and being randomised to TAU made it difficult to attend appointments. Conclusions This feasibility RCT aimed to test recruitment, randomisation, retention, and data collection methods, but recruited only 19 participants. This illustrates the importance of undertaking feasibility studies prior to fully powered RCTs. From the qualitative interviews we found that potential recruits were not at equipoise for recruitment. An alternative methodology, for example a preference RCT recruiting from multiple locations, needs to be explored in future trials.
Factors associated with the prescribing of high-dose opioids in primary care: a systematic review and meta-analysis
Background: The risks of harms from opioids increase substantially at high doses, and high-dose prescribing has increased in primary care. However, little is known about what leads to high-dose prescribing, and studies exploring this have not been synthesized. We, therefore, systematically synthesized factors associated with the prescribing of high-dose opioids in primary care. Methods: We conducted a systematic review of observational studies in high-income countries that used patientlevel primary care data and explored any factor(s) in people for whom opioids were prescribed, stratified by oral morphine equivalents (OME). We defined high doses as ≥ 90 OME mg/day. We searched MEDLINE, Embase, Web of Science, reference lists, forward citations, and conference proceedings from database inception to 5 April 2019. Two investigators independently screened studies, extracted data, and appraised the quality of included studies using the Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies. We pooled data on factors using random effects meta-analyses and reported relative risks (RR) or mean differences with 95% confidence intervals (CI) where appropriate. We also performed a number needed to harm (NNTH) calculation on factors when applicable. Results: We included six studies with a total of 4,248,119 participants taking opioids, of whom 3.64% (n = 154,749) were taking high doses. The majority of included studies (n = 4) were conducted in the USA, one in Australia and one in the UK. The largest study (n = 4,046,275) was from the USA. Included studies were graded as having fair to good quality evidence. The co-prescription of benzodiazepines (RR 3.27, 95% CI 1.32 to 8.13, I2 = 99.9%), depression (RR 1.38, 95% CI 1.27 to 1.51, I2 = 0%), emergency department visits (RR 1.53, 95% CI 1.46 to 1.61, I2 = 0%, NNTH 15, 95% CI 12 to 20), unemployment (RR 1.44, 95% CI 1.27 to 1.63, I2 = 0%), and male gender (RR 1.21, 95% CI 1.14 to 1.28, I2 = 78.6%) were significantly associated with the prescribing of high-dose opioids in primary care. Conclusions: High doses of opioids are associated with greater risks of harms. Associated factors such as the coprescription of benzodiazepines and depression identify priority areas that should be considered when selecting, identifying, and managing people taking high-dose opioids in primary care. Coordinated strategies and services that promote the safe prescribing of opioids are needed.
Supporting social prescribing in primary care by linking people to local assets: a realist review
Social prescribing is a way of addressing the ‘non-medical’ needs (e.g. loneliness, debt, housing problems) that can affect people’s health and well-being. Connector schemes (e.g. delivered by care navigators or link workers) have become a key component to social prescribing’s delivery. Those in this role support patients by either (a) signposting them to relevant local assets (e.g. groups, organisations, charities, activities, events) or (b) taking time to assist them in identifying and prioritising their ‘non-medical’ needs and connecting them to relevant local assets. To understand how such connector schemes work, for whom, why and in what circumstances, we conducted a realist review. Method A search of electronic databases was supplemented with Google alerts and reference checking to locate grey literature. In addition, we sent a Freedom of Information request to all Clinical Commissioning Groups in England to identify any further evaluations of social prescribing connector schemes. Included studies were from the UK and focused on connector schemes for adult patients (18+ years) related to primary care. Results Our searches resulted in 118 included documents, from which data were extracted to produce context-mechanism-outcome configurations (CMOCs). These CMOCs underpinned our emerging programme theory that centred on the essential role of ‘buy-in’ and connections. This was refined further by turning to existing theories on (a) social capital and (b) patient activation. Conclusion Our realist review highlights how connector roles, especially link workers, represent a vehicle for accruing social capital (e.g. trust, sense of belonging, practical support). We propose that this then gives patients the confidence, motivation, connections, knowledge and skills to manage their own well-being, thereby reducing their reliance on GPs. We also emphasise within the programme theory situations that could result in unintended consequences (e.g. increased demand on GPs).
Parents' perceptions of antibiotic use and antibiotic resistance (PAUSE): a qualitative interview study.
BACKGROUND: There remains public misconception about antibiotic use and resistance. Preschool children are at particular risk of receiving unnecessary antibiotics because they commonly present in primary care and many childhood infections are self-limiting. OBJECTIVES: The aim of our study was to explore parents' perceptions and understanding of antibiotic use and resistance in the context of their young child with an acute respiratory tract infection (RTI) and to explore strategies parents would find acceptable to minimize antibiotic resistance for their families. METHODS: Semi-structured interviews were conducted with 23 parents of preschool children who recently had an acute RTI across greater Oxfordshire, UK (2016-17 winter). We explored their beliefs about antibiotics, understanding of antibiotic resistance and views on current public antibiotic awareness campaigns at the time. Thematic analysis was used to analyse the data. RESULTS: Parents had a sense of optimism and considered their families to be at low risk of antibiotic resistance because their families were 'low users' of antibiotics. Very few parents considered antibiotic resistance as a possible harm of antibiotics. Parents thought they were acting morally responsibly by following campaign messages. They wanted future campaigns to have a relevant, accessible message for families about the impact of antibiotic resistance. CONCLUSIONS: Future communication about the potential impact of unnecessary antibiotic use and antibiotic resistance needs to focus on outcomes that parents of young children can relate to (e.g. infection recurrence) and in a format that parents will engage with (e.g. face-to-face dissemination at playgroups and parent/child community events) to make a more informed decision about the risks and benefits of antibiotics for their child.
Heart failure disease management: a systematic review of effectiveness in heart failure with preserved ejection fraction
Heart failure with preserved ejection fraction (HFpEF) poses a substantial challenge for clinicians, but there is little guidance for effective management. The aim of this systematic review was to determine if there was evidence that disease management programmes (DMPs) improved outcomes for patients with HFpEF. Methods and results A systematic review of controlled studies in English or Greek of DMPs including patients with HFpEF from 2008 to 2018 was conducted using CINAHL, Cochrane, MEDLINE, and Embase. Interventions were assessed using a DMP taxonomy and scored for complexity and intensity. Bias was assessed using the Cochrane Collaboration tool. Initial and updated searches found 6089 titles once duplicates were removed. The final analysis included 18 studies with 5435 HF patients: 1866 patients (34%, study ranges 18–100%) had potential HFpEF (limited by variable definitions). Significant heterogeneity in terms of the population, intervention, comparisons, and outcomes prohibited meta‐analysis. Statistically significant or positive trends were found in mortality, hospitalization rates, self‐care ability, quality of life, anxiety, depression, and sleep, but findings were not robust or consistent. Four studies reported results separately for study‐defined HFpEF, with two finding less positive effect on outcomes. Conclusions Varying definitions of HFpEF used in studies are a substantial limitation in interpretation of findings. The reduced efficacy noted in contemporary HF DMP studies may not only be due to improvements in usual care but may also reflect inclusion of heterogeneous patients with HFpEF or HF with mid‐range EF who may not respond in the same way as HFrEF to individual components. Given that patients with HFpEF are older and multi‐morbid, DMPs targeting HFpEF should not rely on a single‐disease focus but provide care that addresses predisposing and presentation phenotypes and draws on the principles of comprehensive geriatric assessment. Other components could also be more targeted to HFpEF such as modification of lifestyle factors for which there is emerging evidence, rather than simply continuing the model of care used in HFrEF. Based on current evidence, HF DMPs may improve mortality, hospitalization rates, self‐care, and quality of life in patients with HFpEF; however, further research specifically tailored to appropriately defined HFpEF is required.
Health and social care providers’ perspectives of older people’s drinking: A systematic review and thematic synthesis of qualitative studies
Background alcohol may increase risks to late-life health, due to its impact on conditions or medication. Older adults must weigh up the potential risks of drinking against perceived benefits associated with positive roles of alcohol in their social lives. Health and social care workers are in a key position to support older people’s decisions about their alcohol use. Objective to systematically review and synthesise qualitative studies exploring health and social care providers’ views and experiences of older people’s drinking and its management in care services. Method a pre-specified search strategy was applied to five electronic databases from inception to June 2018. Grey literature, relevant journals, references and citations of included articles were searched. Two independent reviewers sifted and quality-appraised articles. Included study findings were analysed through thematic synthesis. Results 18 unique studies were included. Four themes explained findings: uncertainty about drinking as a legitimate concern in care provision for older people; the impact of preconceptions on work with older adults; sensitivity surrounding alcohol use in later life; and negotiating responsibility for older adults’ alcohol use. Discipline- and country-specific patterns are highlighted. Conclusions reservations about addressing alcohol could mean that service providers do not intervene with older adults. Judgements of whether older care recipients’ drinking warrants intervention are complex. Providers will need support and training to recognise and provide appropriate intervention for drinking amongst older care recipients.
Managing loneliness: a qualitative study of older people’s views
Engaging with older people who self-identify as lonely may help professionals in mental health and other services understand how they deal with loneliness. The evidence-base for effective interventions to address loneliness is inconclusive. This study aimed to explore how community-dwelling lonely older people in England manage their experiences of loneliness. Twenty eight community-dwelling older people identifying as lonely, based on responses to two loneliness measures (self-report and a standardised instrument), participated in in-depth interviews between 2013 and 2014. Fifteen lived alone. Thematic analysis of transcribed interviews was conducted by a multidisciplinary team including older people. Participants drew on a range of strategies to ameliorate their distress which had been developed over their lives and shaped according to individual coping styles and contexts. Strategies included physical engagement with the world beyond their home, using technologies, planning, and engagement with purpose in an ‘outside world’, and acceptance, endurance, revealing and hiding, positive attitude and motivation, and distraction within an ‘inside world’. Strategies of interests and hobbies, comparative thinking, religion and spirituality and use of alcohol straddled both the inside and outside worlds. Participants conveyed a personal responsibility for managing feelings of loneliness rather than relying on others. This study includes the experiences of those living with loneliness whilst also living with other people. When developing policy and practice responses to loneliness it is important to listen attentively to the views of those who may not be engaging with services designed for ‘the lonely’ and to consider their own strategies for managing it.
Development and validation of the Cambridge Multimorbidity Score
BACKGROUND: Health services have failed to respond to the pressures of multimorbidity. Improved measures of multimorbidity are needed for conducting research, planning services and allocating resources. METHODS: We modelled the association between 37 morbidities and 3 key outcomes (primary care consultations, unplanned hospital admission, death) at 1 and 5 years. We extracted development (n = 300 000) and validation (n = 150 000) samples from the UK Clinical Practice Research Datalink. We constructed a general-outcome multimorbidity score by averaging the standardized weights of the separate outcome scores. We compared performance with the Charlson Comorbidity Index. RESULTS: Models that included all 37 conditions were acceptable predictors of general practitioner consultations (C-index 0.732, 95% confidence interval [CI] 0.731–0.734), unplanned hospital admission (C-index 0.742, 95% CI 0.737–0.747) and death at 1 year (C-index 0.912, 95% CI 0.905–0.918). Models reduced to the 20 conditions with the greatest combined prevalence/weight showed similar predictive ability (C-indices 0.727, 95% CI 0.725–0.728; 0.738, 95% CI 0.732–0.743; and 0.910, 95% CI 0.904–0.917, respectively). They also predicted 5-year outcomes similarly for consultations and death (C-indices 0.735, 95% CI 0.734–0.736, and 0.889, 95% CI 0.885–0.892, respectively) but performed less well for admissions (C-index 0.708, 95% CI 0.705–0.712). The performance of the general-outcome score was similar to that of the outcome-specific models. These models performed significantly better than those based on the Charlson Comorbidity Index for consultations (C-index 0.691, 95% CI 0.690–0.693) and admissions (C-index 0.703, 95% CI 0.697–0.709) and similarly for mortality (C-index 0.907, 95% CI 0.900–0.914). INTERPRETATION: The Cambridge Multimorbidity Score is robust and can be either tailored or not tailored to specific health outcomes. It will be valuable to those planning clinical services, policymakers allocating resources and researchers seeking to account for the effect of multimorbidity. Patients with multiple long-term health conditions are commonly seen by clinicians in generalist and specialist settings.1,2 Services and policies have failed to respond to the pressures that multimorbidity places on primary and secondary care. These pressures are driven by the aging population, by policies that promote rapid access over longer consultations and continuity of care, and by single-disease guidelines and performance targets, which lead to overprescribing without addressing the priorities of the patients themselves.3,4 Several approaches have been used to quantify multimorbidity. Simple counts of conditions show a clear association with various outcomes, including primary care utilization, unplanned hospital admission and death.5,6 Weighted approaches allow for differences in the strength of association between specific morbidities and a given outcome, as is the case for the Charlson Comorbidity Index, a composite morbidity score with condition weightings based on mortality.7 Although its performance has exceeded that of several other metrics,4 clinical practice has advanced considerably since its development in the 1980s, and the high weightings of particular conditions have been questioned.8 A further problem with such indices is that weightings are generally based on a specific outcome such as death, and the indices may not predict other outcomes. The lists of conditions are also problematic. A minimum list of 12 conditions has been proposed.9 However, a limited list may fail to capture important health problems, and comprehensive lists such as the Adjusted Clinical Groups (ACG) system may be challenging to implement. The aim of the current study was to develop and validate a transparent, simple measure of multimorbidity based on data from United Kingdom general practitioner (GP) records and weighted on different clinical outcomes, for use in future studies of multimorbidity and for resource allocation.
Machine learning detection of Atrial Fibrillation using wearable technology
Atrial Fibrillation is the most common arrhythmia worldwide with a global age adjusted prevalence of 0.5% in 2010. Anticoagulation treatment using warfarin or direct oral anticoagulants is effective in reducing the risk of AF-related stroke by approximately two-thirds and can provide a 10% reduction in overall mortality. There has been increased interest in detecting AF due to its increased incidence and the possibility to prevent AF-related strokes. Inexpensive consumer devices which measure the ECG may have the potential to accurately detect AF but do not generally incorporate diagnostic algorithms. Machine learning algorithms have the potential to improve patient outcomes particularly where diagnoses are made from large volumes or complex patterns of data such as in AF. Methods We designed a novel AF detection algorithm using a de-correlated Lorenz plot of 60 consecutive RR intervals. In order to reduce the volume of data, the resulting images were compressed using a wavelet transformation (JPEG200 algorithm) and the compressed images were used as input data to a Support Vector Machine (SVM) classifier. We used the Massachusetts Institute of Technology (MIT)—Beth Israel Hospital (BIH) Atrial Fibrillation database and the MIT-BIH Arrhythmia database as training data and verified the algorithm performance using RR intervals collected using an inexpensive consumer heart rate monitor device (Polar-H7) in a case-control study. Results The SVM algorithm yielded excellent discrimination in the training data with a sensitivity of 99.2% and a specificity of 99.5% for AF. In the validation data, the SVM algorithm correctly identified AF in 79/79 cases; sensitivity 100% (95% CI 95.4%-100%) and non-AF in 328/336 cases; specificity 97.6% (95% CI 95.4%-99.0%). Conclusions An inexpensive wearable heart rate monitor and machine learning algorithm can be used to detect AF with very high accuracy and has the capability to transmit ECG data which could be used to confirm AF. It could potentially be used for intermittent screening or continuously for prolonged periods to detect paroxysmal AF. Further work could lead to cost-effective and accurate estimation of AF burden and improved risk stratification in AF.
Development and Validation of Lifestyle-Based Models to Predict Incidence of the Most Common Potentially Preventable Cancers
Background: Most risk models for cancer are either specific to individual cancers or include complex or predominantly non-modifiable risk factors. Methods: We developed lifestyle-based models for the five cancers for which the most cases are potentially preventable through lifestyle change in the UK (lung, colorectal, bladder, kidney, and esophageal for men and breast, lung, colorectal, endometrial, and kidney for women). We selected lifestyle risk factors from the European Code against Cancer and obtained estimates of relative risks from meta-analyses of observational studies. We used mean values for risk factors from nationally representative samples and mean 10-year estimated absolute risks from routinely available sources. We then assessed the performance of the models in 23,768 participants in the EPIC-Norfolk cohort who had no history of the five selected cancers at baseline. Results: In men, the combined risk model showed good discrimination [AUC, 0.71; 95% confidence interval (CI), 0.69–0.73] and calibration. Discrimination was lower in women (AUC, 0.59; 95% CI, 0.57–0.61), but calibration was good. In both sexes, the individual models for lung cancer had the highest AUCs (0.83; 95% CI, 0.80–0.85 for men and 0.82; 95% CI, 0.76–0.87 for women). The lowest AUCs were for breast cancer in women and kidney cancer in men. Conclusions: The discrimination and calibration of the models are both reasonable, with the discrimination for individual cancers comparable or better than many other published risk models. Impact: These models could be used to demonstrate the potential impact of lifestyle change on risk of cancer to promote behavior change.
Supporting nutrition in frail older people: a qualitative study exploring views of primary care and community health professionals
Background Malnutrition is associated with increased morbidity and mortality, and is very common in frail older people. However, little is known about how weight loss in frail older people can be managed in primary care. Aims To explore the views and practices of primary care and community professionals on the management of malnutrition in frail older people; identify components of potential primary care-based interventions for this group; and identify training and support required to deliver such interventions. Design and setting Qualitative study in primary care and community settings. Method Seven focus groups and an additional interview were conducted with general practice teams, frailty multidisciplinary teams (MDTs), and community dietitians in London and Hertfordshire, UK (n = 60 participants). Data were analysed using thematic analysis. Results Primary care and community health professionals perceived malnutrition as a multifaceted problem. There was an agreement that there is a gap in care provided for malnutrition in the community. However, there were conflicting views regarding professional accountability. Challenges commonly reported by primary care professionals included overwhelming workload and lack of training in nutrition. Community MDT professionals and dietitians thought that an intervention to tackle malnutrition would be best placed in primary care and suggested opportunistic screening interventions. Education was an essential part of any intervention, complemented by social, emotional, and/or practical support for frailer or socially isolated older people. Conclusions Future interventions should include a multifaceted approach. Education tailored to the needs of older people, carers, and healthcare professionals is a necessary component of any intervention.
Examining the effectiveness of general practitioner and nurse promotion of electronic cigarettes versus standard care for smoking reduction and abstinence in hardcore smokers with smoking-related chronic disease: protocol for a randomised controlled trial
Background Despite the clear harm associated with smoking tobacco, many people with smoking-related chronic diseases or serious mental illnesses (SMI) are unwilling or unable to stop smoking. In many cases, these smokers have tried and exhausted all methods to stop smoking and yet clinicians are repeatedly mandated to offer them during routine consultations. Providing nicotine through electronic cigarettes (e-cigarettes) may reduce the adverse health consequences associated with tobacco smoking, but these are not currently offered. The aim of this study is to examine the feasibility, acceptability and effectiveness of general practitioners (GPs) and nurses delivering a brief advice intervention on e-cigarettes and offering an e-cigarette starter pack and patient support resources compared with standard care in smokers with smoking-related chronic diseases or SMI who are unwilling to stop smoking. Methods/design This is an individually randomised, blinded, two-arm trial. Smokers with a smoking-related chronic condition or SMI with no intention of stopping smoking will be recruited through primary care registers. Eligible participants will be randomised to one of two groups if they decline standard care for stopping smoking: a control group who will receive no additional support beyond standard care; or an intervention group who will receive GP or nurse-led brief advice about e-cigarettes, an e-cigarette starter pack with accompanying practical support booklet, and telephone support from experienced vapers and online video tutorials. The primary outcome measures will be smoking reduction, measured through changes in cigarettes per day and 7-day point-prevalence abstinence at 2 months. Secondary outcomes include smoking reduction, 7-day point-prevalence abstinence and prolonged abstinence at 8 months. Other outcomes include patient recruitment and follow-up, patient uptake and use of e-cigarettes, nicotine intake, contamination of randomisation and practitioner adherence to the delivery of the intervention. Qualitative interviews will be conducted in a subsample of practitioners, patients and the vape team to garner their reactions to the programme. Discussion This is the first randomised controlled trial to investigate whether e-cigarette provision alongside a brief intervention delivered by practitioners leads to reduced smoking and abstinence among smokers with smoking-related chronic diseases or SMI.
Dietary Approaches to the Management Of type 2 Diabetes (DIAMOND): protocol for a randomised feasibility trial
Introduction Some clinicians have observed that low-carbohydrate, low-energy diets can improve blood glucose control, with reports of remission from type 2 diabetes in some patients. In clinical trials, support for low-carbohydrate, low-energy diets has been provided by specialist staff and these programmes are unsuitable for widespread deployment in routine primary care. The aim of this trial is to test whether a newly developed behavioural support programme can effectively deliver a low-energy, low-carbohydrate diet in a primary care setting. Methods and analysis This is a feasibility randomised controlled trial (RCT) with embedded qualitative study. Thirty adult patients with type 2 diabetes and body mass index ≥30 kg/m2 in 2–4 general practices will be randomised 2:1 intervention or control and followed up over 12 weeks. The intervention diet comprises 8 weeks of a low-carbohydrate food-based diet providing around 800 kcal/day, followed by 4 weeks of weight maintenance. This programme will be delivered by practice nurses, who will also support patients through goal-setting, motivation and self-monitoring across four appointments, and provide a self-help booklet with recipes, shopping lists and other behavioural support. Primary outcome measures of feasibility will be met if CIs do not cross the following proportions: that 60% of intervention group participants attempt the dietary intervention, healthcare professionals conduct the intervention delivery session with at least 60% of essential elements present and 60% of participants attend the final follow-up session. Secondary outcome measures will assess process and qualitative measures, as well as exploratory outcomes including change in haemoglobin A1c and change in weight.
Advancing good governance in data sharing and biobanking - international aspects
Ethical and effective data-sharing among countries can be achieved by considering the interests of all relevant parties: research participants, researchers and funders. Fears of exploitation, however, both of research participants and researchers from low- and middle-income countries (LMIC), can undermine the free flow of data necessary for scientific advancement. In this Open Letter, two case studies presented at the 2018 Global Forum on Bioethics in Research meeting on the Ethics of data sharing and biobanking in Cape Town, South Africa, function as the focal point for a reflection on the attributes of an ideal model of good data governance and how it can help support ethical best practices in biobanking and data sharing. Consideration of the case studies as well as the literature indicate three broad principles that need to be reflected in an ideal data governance framework: (i) collaboration - both among researchers as well as between researchers and participants, (ii) fairness – ensuring that all parties in international collaborations, the data provider, primary data gathering LMIC researcher and the high income country (HIC) institution/funder are treated fairly, and (iii) working towards a level playing field – neither collaboration nor fairness can be effectively achieved with the existing power differential between HIC and LMIC researchers/institutions; it is therefore necessary to work towards achieving a more level playing field between partners in research collaborations. Promoting good governance of data through fair, efficient and accountable governance frameworks can help build trust and ensure continued international data sharing.