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We lead multidisciplinary applied research and training to rethink the way health care is delivered in general practice and across the community.
Intervention development of a brief messaging intervention for a randomised controlled trial to improve diabetes treatment adherence in sub-Saharan Africa
© 2021, The Author(s). Background: Brief messaging interventions, including Short Message Service (SMS) text-messages, delivered via mobile device platforms, show promise to support and improve treatment adherence. To understand how these interventions work, and to facilitate transparency, we need clear descriptions of the intervention development process. Method: We describe and reflect on the process of designing and pretesting an evidence- and theory-informed brief messaging intervention, to improve diabetes treatment adherence in sub-Saharan Africa. We followed the stepwise approach recommended by the Medical Research Council, United Kingdom (MRC UK) Framework for Development and Evaluation of Complex Health Interventions and guidance for mobile health intervention development. Results: We used a four-phase, iterative approach that first generated primary and secondary evidence on the lived experience of diabetes, diabetes treatment services and mobile-phone use. Second, we designed a type 2 diabetes-specific, brief text-message library, building on our previous hypertension text-message library, as well as drawing on the primary and secondary data from phase one, and on expert opinion. We then mapped the brief text-messages onto behaviour change (COM-B) theoretical constructs. Third, we refined and finalised the newly developed brief text-message library through stakeholder consultation and translated it into three local languages. Finally, we piloted the intervention by pre-testing the automated delivery of the brief text-messages in the trial sites in Malawi and South Africa. The final SMS text Adherence suppoRt for people with type 2 diabetes (StAR2D) intervention was tested in a randomised controlled trial in Malawi and South Africa (trial registration: ISRCTN70768808). Conclusion: The complexity of public health interventions requires that we give more attention to intervention development work. Our documentation and reflection on the StAR2D intervention development process promotes transparency, replicability, assessment of intervention quality, and comparison with other studies.
Mindfulness-based programmes to reduce stress and enhance well-being at work: A realist review
Objectives To understand how and why workplace mindfulness-based programmes (MBPs) work or do not work. Design A realist review. Eligibility criteria for selection We considered any studies (experimental quasi-experimental, observational, qualitative and mixed-methods studies) of workplace MBPs as long as they provided data to explain our programme theories. All MBP formats and delivery modes were included. Analysis Consistent with realist review methodology, we systematically screened and analysed data to explain how and why workplace MBPs work or do not work. These explanations were consolidated into a programme theory augmented by theories from organisational literature, such as conservation of resources theory. Results Findings from 75 primary studies suggest that workplace MBPs enable participants (including healthcare professionals) to deal more skillfully with stressful events and improve their well-being. The mechanisms involved can be grouped around awareness/self-regulation, acceptance/compassion, feeling permitted to take care of self, sense of growth and promise of goal attainment. In order for professionals to invest in an MBP and benefit from it, it is important that they feel safe to engage with self-care at work and share emotional difficulties among peers. It is also important that employees are able to link the programme and its activities to existing goals and practices. Concerns of being non-productive, of not getting work done or of being exposed in front of colleagues can result in strategic use of brief mindfulness exercises, non-adherence or drop-out. Conclusions Simply offering an MBP to (healthcare) professionals in order to reduce stress and enhance well-being does not suffice. A supportive environment must exist in order for the programme's benefits to be reaped. PROSPERO registration number CRD42018086280.
Effect of glucose and sucrose on cognition in healthy humans: A systematic review and meta-analysis of interventional studies
© 2020 The Author(s) 2020. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. Context: Evidence suggests that plasma glucose levels may influence cognitive performance, but this has not been systematically reviewed and quantified. Objective: The aim of this review was to investigate the potential effects of glucose and sucrose, compared with placebo, on cognition in healthy humans. Data Sources: The electronic databases PubMed and Web of Science were searched up to December 2019. Reference lists of selected articles were checked manually. Study Selection: Randomized controlled trials or crossover trials that compared glucose or sucrose with placebo for effects on cognition were eligible. Data Extraction: Potentially eligible articles were selected independently by 2 authors. Risk of bias was assessed through the Cochrane Collaboration tool. Standardized mean differences (SMDs) were obtained from random-effects meta-analyses for a subsample of studies that reported the same outcomes. Results: Thirty-seven trials were identified, of which 35 investigated the effect of glucose consumption compared with placebo on cognition. Two studies found no effect of glucose on cognition, while the others found mixed results. Only 3 of the 37 studies investigated the effects of sucrose intake, reporting mixed results. Meta-analyses revealed a significantly positive effect of glucose compared with control, but only when a verbal performance test (immediate word recall) was used in parallel-design studies (SMD = 0.61; 95%CI, 0.20-1.02; I2 = 0%). Twenty-four studies were classified as having high risk of bias for the selection procedure. Conclusions: A limited body of evidence shows a beneficial effect of glucose in individuals performing immediate verbal tasks. High-quality trials with standardized cognitive measurements are needed to better establish the effect of glucose or sucrose on cognition. Systematic Review Registration: PROSPERO registration number CRD42019122939.
Primary care treatment of insomnia: Study protocol for a pragmatic, multicentre, randomised controlled trial comparing nurse-delivered sleep restriction therapy to sleep hygiene (the HABIT trial)
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. Introduction Insomnia is a prevalent sleep disorder that negatively affects quality of life. Multicomponent cognitive-behavioural therapy (CBT) is the recommended treatment but access remains limited, particularly in primary care. Sleep restriction therapy (SRT) is one of the principal active components of CBT and could be delivered by generalist staff in primary care. The aim of this randomised controlled trial is to establish whether nurse-delivered SRT for insomnia disorder is clinically and cost-effective compared with sleep hygiene advice. Methods and analysis In the HABIT (Health-professional Administered Brief Insomnia Therapy) trial, 588 participants meeting criteria for insomnia disorder will be recruited from primary care in England and randomised (1:1) to either nurse-delivered SRT (plus sleep hygiene booklet) or sleep hygiene booklet on its own. SRT will be delivered over 4 weekly sessions; total therapy time is approximately 1 hour. Outcomes will be collected at baseline, 3, 6 and 12 months post-randomisation. The primary outcome is self-reported insomnia severity using the Insomnia Severity Index at 6 months. Secondary outcomes include health-related and sleep-related quality of life, depressive symptoms, use of prescribed sleep medication, diary and actigraphy-recorded sleep parameters, and work productivity. Analyses will be intention-to-treat. Moderation and mediation analyses will be conducted and a cost-utility analysis and process evaluation will be performed. Ethics and dissemination Ethical approval was granted by the Yorkshire and the Humber - Bradford Leeds Research Ethics Committee (reference: 18/YH/0153). We will publish our primary findings in high-impact, peer-reviewed journals. There will be further outputs in relation to process evaluation and secondary analyses focussed on moderation and mediation. Trial results could make the case for the introduction of nurse-delivered sleep therapy in primary care, increasing access to evidence-based treatment for people with insomnia disorder. Trial registration number ISRCTN42499563.
Over-use of thyroid testing in Canadian and UK primary care in frequent attenders: A cross-sectional study
Background: Thyroid-stimulating hormone (TSH) is a common test used to detect and monitor clinically significant hypo- and hyperthyroidism. Population-based screening of asymptomatic adults for thyroid disorders is not recommended. Objective: The research objectives were to determine patterns of TSH testing in Canadian and English primary care practices, as well as patient and physician practice characteristics associated with testing TSH for primary care patients with no identifiable indication. Methods: In this 2-year cross-sectional observational study, Canadian and English electronic medical record databases were used to identify patients and physician practices. Cohorts of patients aged 18 years or older, without identifiable indications for TSH testing, were generated from these databases. Analyses were performed using a random-effects logistic regression to determine patient and physician practice characteristics associated with increased testing. We determined the proportion of TSH tests performed concurrently with at least one common screening blood test (lipid profile or hemoglobin A1c). Standardised proportions of TSH test per family practice were used to examine the heterogeneity in the populations. Results: At least one TSH test was performed in 35.97% (N = 489 663) of Canadian patients and 29.36% (N = 1 030 489) of English patients. Almost all TSH tests in Canada and England (95.69% and 99.23% respectively) were within the normal range (0.40-5.00 mU/L). A greater number of patient-physician encounters was the strongest predictor of TSH testing. It was determined that 51.40% of TSH tests in Canada and 76.55% in England were performed on the same day as at least one other screening blood test. There was no association between the practice size and proportion of asymptomatic patients tested. Conclusions: This comparative binational study found TSH patterns suggestive of over-testing and potentially thyroid disorder screening in both countries. There may be significant opportunities to improve the appropriateness of TSH ordering in Canada and England and therefore improve the allocation of limited system resources.
Long COVID and Health Inequities: The Role of Primary Care
Policy Points An estimated 700,000 people in the United States have “long COVID,” that is, symptoms of COVID-19 persisting beyond three weeks. COVID-19 and its long-term sequelae are strongly influenced by social determinants such as poverty and by structural inequalities such as racism and discrimination. Primary care providers are in a unique position to provide and coordinate care for vulnerable patients with long COVID. Policy measures should include strengthening primary care, optimizing data quality, and addressing the multiple nested domains of inequity.
Joint Associations Between Body Mass Index and Waist Circumference With Atrial Fibrillation in Men and Women.
Background Associations between adiposity and atrial fibrillation (AF) might differ between sexes. We aimed to determine precise estimates of the risk of AF by body mass index (BMI) and waist circumference (WC) in men and women. Methods and Results Between 2008 and 2013, over 3.2 million adults attended commercial screening clinics. Participants completed health questionnaires and underwent physical examination along with cardiovascular investigations, including an ECG. We excluded those with cardiovascular and cardiac disease. We used multivariable logistic regression and determined joint associations of BMI and WC and the risk of AF in men and women by comparing likelihood ratio χ2 statistics. Among 2.1 million included participants 12 067 (0.6%) had AF. A positive association between BMI per 5 kg/m2 increment and AF was observed, with an odds ratio of 1.65 (95% CI, 1.57-1.73) for men and 1.36 (95% CI, 1.30-1.42) for women among those with a BMI above 20 kg/m2. We found a positive association between AF and WC per 10 cm increment, with an odds ratio of 1.47 (95% CI, 1.36-1.60) for men and 1.37 (95% CI, 1.26-1.49) for women. Improvement of likelihood ratio χ2 was equal after adding BMI and WC to models with all participants. In men, WC showed stronger improvement of likelihood ratio χ2 than BMI (30% versus 23%). In women, BMI showed stronger improvement of likelihood ratio χ2 than WC (23% versus 12%). Conclusions We found a positive association between BMI (above 20 kg/m2) and AF and between WC and AF in both men and women. BMI seems a more informative measure about risk of AF in women and WC seems more informative in men.
Point-of-care HbA 1c testing in an urban primary care diabetes clinic in South Africa: A mixed methods feasibility study
© 2021 BMJ Publishing Group. All rights reserved. Introduction Monitoring and treatment of type 2 diabetes in South Africa usually takes place in primary care using random blood glucose testing to guide treatment decisions. This study explored the feasibility of using point-of-care haemoglobin A1c (HbA 1c) testing in addition to glucose testing in a busy primary care clinic in Cape Town, South Africa. Subjects 185 adults aged 19-88 years with type 2 diabetes. Materials and methods Participants recruited to this mixed methods cohort study received a point-of-care HbA 1c test. Doctors were asked to use the point-of-care HbA 1c result for clinical decision-making. Qualitative interviews were held with clinical staff. Results Point-of-care HbA 1c test results were obtained for 165 participants of whom 109 (65%) had poor glycaemic control (>8% HbA 1c, 64 mmol/mol). Medical officers reported using a combination of HbA 1c and blood glucose 77% of the time for clinical decision-making. Nurses found the analyser easy to use and doctors valued having the HbA 1c result to help with decision-making. Discussion Our results suggest that 30% of patients may have received inappropriate medication or not received necessary additional medication if random blood glucose alone had been used in routine appointments. Clinicians valued having access to the HbA 1c test result to help them make treatment decisions.
Multivariate Generalized Linear Mixed-Effects Models for the Analysis of Clinical Trial–Based Cost-Effectiveness Data
Economic evaluations conducted alongside randomized controlled trials are a popular vehicle for generating high-quality evidence on the incremental cost-effectiveness of competing health care interventions. Typically, in these studies, resource use (and by extension, economic costs) and clinical (or preference-based health) outcomes data are collected prospectively for trial participants to estimate the joint distribution of incremental costs and incremental benefits associated with the intervention. In this article, we extend the generalized linear mixed-model framework to enable simultaneous modeling of multiple outcomes of mixed data types, such as those typically encountered in trial-based economic evaluations, taking into account correlation of outcomes due to repeated measurements on the same individual and other clustering effects. We provide new wrapper functions to estimate the models in Stata and R by maximum and restricted maximum quasi-likelihood and compare the performance of the new routines with alternative implementations across a range of statistical programming packages. Empirical applications using observed and simulated data from clinical trials suggest that the new methods produce broadly similar results as compared with Stata’s merlin and gsem commands and a Bayesian implementation in WinBUGS. We highlight that, although these empirical applications primarily focus on trial-based economic evaluations, the new methods presented can be generalized to other health economic investigations characterized by multivariate hierarchical data structures.
Burden of infections on older patients presenting to general practice: a registry-based study
BACKGROUND: Estimates on the incidence rates of infections are needed to assess the burden of disease in the community. OBJECTIVE: To assess incidence rates of potentially serious infections in patients aged 65 years and over presenting to Flemish general practice from 2000 to 2015, and to describe patient characteristics. METHODS: We performed a retrospective study, based on data provided by the Intego morbidity registry of the KU Leuven, which includes the electronic medical records of 111 general practitioners. Incidence rates were calculated taking person-time at risk into account, and longitudinal trends from 2000 to 2015 were analysed using autoregressive time-series analyses. RESULTS: On average, a person aged 65 years or older has an 8.0% risk of getting a potentially serious infection each year. Acute cystitis was the most often occurring potentially serious infection [39.8/1000 person-years; 95% confidence interval (CI): 39.4-40.2], followed by influenza like illness (ILI, 24.3/1000 person-years; 95% CI: 24.0-24.6) and pneumonia (9.7/1000 person-years; 95% CI: 9.5-9.9). The incidence rates of pneumonia were higher in older age groups and in men, whereas they were markedly lower for ILI at older ages, in both genders. From 2000 to 2015, overall incidence rates decreased significantly for ILI, while they increased in women for pneumonia, acute cystitis and pyelonephritis. Common chronic comorbidities were non-insulin dependent diabetes, chronic obstructive pulmonary disease, asthma, heart failure and chronic renal insufficiency. CONCLUSIONS: Potentially serious infections are quite common in an older patient population presenting to primary care. They are accompanied by several chronic comorbidities, which may differ by infection type.
Psychosocial needs of adolescents and young adults with eczema: A secondary analysis of qualitative data to inform a behaviour change intervention.
OBJECTIVES: This study aimed to explore adolescents and young adults' experiences of symptoms related to their eczema in order to determine their psychosocial needs. DESIGN: A secondary qualitative analysis of two data sources collected through semi-structured interviews for two different projects, SKINS project and Eczema Care Online project. METHODS: In total, there were 28 transcripts with adolescents and young adults with eczema having a mean age of 19.5 years available to analyse. Interview data were collected from face-to-face interviews that were recorded and transcribed. Inductive thematic analysis explored data about symptoms and organized according to psychosocial needs. RESULTS: Adolescents and young adults with eczema experience both visible symptoms (such as flaky, dry, and inflamed skin) and invisible symptoms (such as itch, pain, exhaustion, and mental distress) that elicit different psychosocial needs. These psychosocial needs are to (i) be understood; (ii) be perceived as normal; and (iii) receive emotional support. Interviewees described a struggle between wanting their peers and family to understand but take their eczema seriously whilst not wanting to stand out and instead to be perceived as 'normal', which they would define as being perceived as other adolescents. This has implications on behaviours, such as seeking support, avoiding going out, hiding their skin, as well as emotional implications, such as social isolation and feeling anxious and low. CONCLUSIONS: Having a better understanding of young people's experiences and psychosocial needs will provide a framework on how best to support adolescents and young adults when managing symptoms related to eczema. Statement of contribution What is already known on this subject? Eczema has a high impact on children and is considered a burden by children and adults with eczema. However, it is unclear what impact eczema has on adolescents and young adults. Adolescents and young adults with chronic conditions are known to be vulnerable to negative psychosocial outcomes but psychosocial needs and how to best support this age group with eczema are unknown What does this add? Three psychosocial needs were developed from evaluating the impact of visible and invisible symptoms of eczema: The need to feel understood (mostly reflective of invisible symptoms such as itch and pain and visible symptoms such as scratching). The need to be perceived as 'normal': visible symptoms such as flaky, inflamed skin make them stand out in comparison with their peers and a need emerged to blend in. The need for emotional support: adolescents and young adults searched for this from their health care providers, from shared experiences and from online resources. Adolescents and young adults with eczema appear to feel ambivalent about wishing the impact of the condition to be acknowledged whilst wishing the condition to be invisible to others. This ambivalence had further impact on feeling self-conscious, seeking support, and dealing with unsolicited advice.
COVIDReady2 study protocol: cross-sectional survey of medical student volunteering and education during the COVID-19 pandemic in the United Kingdom
<jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>The coronavirus disease 2019 pandemic has led to global disruption of healthcare. Many students volunteered to provide clinical support. Volunteering to work in a clinical capacity was a unique medical education opportunity; however, it is unknown whether this was a positive learning experience or which volunteering roles were of most benefit to students.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>The COVIDReady2 study is a national cross-sectional study of all medical students at medical schools in the United Kingdom. The primary outcome is to explore the experiences of medical students who volunteered during the pandemic in comparison to those who did not. We will compare responses to determine the educational benefit and issues they faced. In addition to quantitative analysis, thematic analysis will be used to identify themes in qualitative responses.</jats:p> </jats:sec><jats:sec> <jats:title>Discussion</jats:title> <jats:p>There is a growing body of evidence to suggest that service roles have potential to enhance medical education; yet, there is a shortage of studies able to offer practical advice for how these roles may be incorporated in future medical education. We anticipate that this study will help to identify volunteer structures that have been beneficial for students, so that similar infrastructures can be used in the future, and help inform medical education in a non-pandemic setting.</jats:p> </jats:sec><jats:sec> <jats:title>Trial registration</jats:title> <jats:p>Not Applicable.</jats:p> </jats:sec>
Adrenaline to improve survival in out-of-hospital cardiac arrest: the PARAMEDIC2 RCT
<jats:sec id="abs1-1"> <jats:title>Background</jats:title> <jats:p>Adrenaline has been used as a treatment for cardiac arrest for many years, despite uncertainty about its effects on long-term outcomes and concerns that it may cause worse neurological outcomes.</jats:p> </jats:sec> <jats:sec id="abs1-2"> <jats:title>Objectives</jats:title> <jats:p>The objectives were to evaluate the effects of adrenaline on survival and neurological outcomes, and to assess the cost-effectiveness of adrenaline use.</jats:p> </jats:sec> <jats:sec id="abs1-3"> <jats:title>Design</jats:title> <jats:p>This was a pragmatic, randomised, allocation-concealed, placebo-controlled, parallel-group superiority trial and economic evaluation. Costs are expressed in Great British pounds and reported in 2016/17 prices.</jats:p> </jats:sec> <jats:sec id="abs1-4"> <jats:title>Setting</jats:title> <jats:p>This trial was set in five NHS ambulance services in England and Wales.</jats:p> </jats:sec> <jats:sec id="abs1-5"> <jats:title>Participants</jats:title> <jats:p>Adults treated for an out-of-hospital cardiac arrest were included. Patients were ineligible if they were pregnant, if they were aged < 16 years, if the cardiac arrest had been caused by anaphylaxis or life-threatening asthma, or if adrenaline had already been given.</jats:p> </jats:sec> <jats:sec id="abs1-6"> <jats:title>Interventions</jats:title> <jats:p>Participants were randomised to either adrenaline (1 mg) or placebo in a 1 : 1 allocation ratio by the opening of allocation-concealed treatment packs.</jats:p> </jats:sec> <jats:sec id="abs1-7"> <jats:title>Main outcome measures</jats:title> <jats:p>The primary outcome was survival to 30 days. The secondary outcomes were survival to hospital admission, survival to hospital discharge, survival at 3, 6 and 12 months, neurological outcomes and health-related quality of life through to 6 months. The economic evaluation assessed the incremental cost per quality-adjusted life-year gained from the perspective of the NHS and Personal Social Services. Participants, clinical teams and those assessing patient outcomes were masked to the treatment allocation.</jats:p> </jats:sec> <jats:sec id="abs1-8"> <jats:title>Results</jats:title> <jats:p>From December 2014 to October 2017, 8014 participants were assigned to the adrenaline (<jats:italic>n</jats:italic> = 4015) or to the placebo (<jats:italic>n</jats:italic> = 3999) arm. At 30 days, 130 out of 4012 participants (3.2%) in the adrenaline arm and 94 out of 3995 (2.4%) in the placebo arm were alive (adjusted odds ratio for survival 1.47, 95% confidence interval 1.09 to 1.97). For secondary outcomes, survival to hospital admission was higher for those receiving adrenaline than for those receiving placebo (23.6% vs. 8.0%; adjusted odds ratio 3.83, 95% confidence interval 3.30 to 4.43). The rate of favourable neurological outcome at hospital discharge was not significantly different between the arms (2.2% vs. 1.9%; adjusted odds ratio 1.19, 95% confidence interval 0.85 to 1.68). The pattern of improved survival but no significant improvement in neurological outcomes continued through to 6 months. By 12 months, survival in the adrenaline arm was 2.7%, compared with 2.0% in the placebo arm (adjusted odds ratio 1.38, 95% confidence interval 1.00 to 1.92). An adjusted subgroup analysis did not identify significant interactions. The incremental cost-effectiveness ratio for adrenaline was estimated at £1,693,003 per quality-adjusted life-year gained over the first 6 months after the cardiac arrest event and £81,070 per quality-adjusted life-year gained over the lifetime of survivors. Additional economic analyses estimated incremental cost-effectiveness ratios for adrenaline at £982,880 per percentage point increase in overall survival and £377,232 per percentage point increase in neurological outcomes over the first 6 months after the cardiac arrest.</jats:p> </jats:sec> <jats:sec id="abs1-9"> <jats:title>Limitations</jats:title> <jats:p>The estimate for survival with a favourable neurological outcome is imprecise because of the small numbers of patients surviving with a good outcome.</jats:p> </jats:sec> <jats:sec id="abs1-10"> <jats:title>Conclusions</jats:title> <jats:p>Adrenaline improved long-term survival, but there was no evidence that it significantly improved neurological outcomes. The incremental cost-effectiveness ratio per quality-adjusted life-year exceeds the threshold of £20,000–30,000 per quality-adjusted life-year usually supported by the NHS.</jats:p> </jats:sec> <jats:sec id="abs1-11"> <jats:title>Future work</jats:title> <jats:p>Further research is required to better understand patients’ preferences in relation to survival and neurological outcomes after out-of-hospital cardiac arrest and to aid interpretation of the trial findings from a patient and public perspective.</jats:p> </jats:sec> <jats:sec id="abs1-12"> <jats:title>Trial registration</jats:title> <jats:p>Current Controlled Trials ISRCTN73485024 and EudraCT 2014-000792-11.</jats:p> </jats:sec> <jats:sec id="abs1-13"> <jats:title>Funding</jats:title> <jats:p>This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in <jats:italic>Health Technology Assessment</jats:italic>; Vol. 25, No. 25. See the NIHR Journals Library website for further project information.</jats:p> </jats:sec>