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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.
Phase 1 safety, tolerability, pharmacokinetics and pharmacodynamic results of KCL-286, a novel retinoic acid receptor-β agonist for treatment of spinal cord injury, in male healthy participants
Aims: KCL-286 is an orally available agonist taht activates the retinoic acid receptor (RAR) β2, a transcription factor which stimulates axonal outgrowth. The investigational medicinal product is being developed for treatment of spinal cord injury (SCI). This adaptive dose escalation study evaluated the tolerability, safety and pharmacokinetics and pharmacodynamic activity of KCL-286 in male healthy volunteers to establish dosing to be used in the SCI patient population. Methods: The design was a double blind, randomized, placebo-controlled dose escalation study in 2 parts: a single ascending dose adaptive design with a food interaction arm, and a multiple ascending dose design. RARβ2 mRNA expression was evaluated in white blood cells. Results: At the highest single and multiple ascending doses (100 mg), no trends or clinically important differences were noted in the incidence or intensity of adverse events (AEs), serious AEs or other safety assessments with none leading to withdrawal from the study. The AEs were dry skin, rash, skin exfoliation, raised liver enzymes and eye disorders. There was an increase in mean maximum observed concentration and area under the plasma concentration–time curve up to 24 h showing a trend to subproportionality with dose. RARβ2 was upregulated by the investigational medicinal product in white blood cells. Conclusion: KCL-286 was well tolerated by healthy human participants following doses that exceeded potentially clinically relevant plasma exposures based on preclinical in vivo models. Target engagement shows the drug candidate activates its receptor. These findings support further development of KCL-286 as a novel oral treatment for SCI.
Protocol for secondary data analysis of 4 UK cohorts examining youth adversity and mental health in the context of intersectionality
BACKGROUND: Youth adversity (e.g., abuse and bullying victimisation) is robust risk factor for later mental health problems (e.g., depression and anxiety). Research shows the prevalence of youth adversity and rates of mental health problems vary by individual characteristics, identity or social groups (e.g., gender and ethnicity). However, little is known about whether the impact of youth adversity on mental health problems differ across the intersections of these characteristics (e.g., white females). This paper reports on a component of the ATTUNE research programme (work package 2) which aims to investigate the impact and mechanisms of youth adversity on depressive and anxiety symptoms in young people by intersectionality profiles. METHODS: The data are from 4 UK adolescent cohorts: HeadStart Cornwall, Oxwell, REACH, and DASH. These cohorts were assembled for adolescents living in distinct geographical locations representing coastal, suburban and urban places in the UK. Youth adversity was assessed using a series of self-report questionnaires and official records. Validated self-report instruments measured depressive and anxiety symptoms. A range of different variables were classified as possible social and cognitive mechanisms. RESULTS AND ANALYSIS: Structural equation modelling (e.g., multiple group models, latent growth models) and multilevel modelling will be used, with adaptation of methods to suit the specific available data, in accord with statistical and epidemiological conventions. DISCUSSION: The results from this research programme will broaden our understanding of the association between youth adversity and mental health, including new information about intersectionality and related mechanisms in young people in the UK. The findings will inform future research, clinical guidance, and policy to protect and promote the mental health of those most vulnerable to the negative consequences of youth adversity.
Clinical and cost-effectiveness of nurse-delivered sleep restriction therapy for insomnia in primary care (HABIT): a pragmatic, superiority, open-label, randomised controlled trial
Background: Insomnia is prevalent and distressing but access to the first-line treatment, cognitive behavioural therapy (CBT), is extremely limited. We aimed to assess the clinical and cost-effectiveness of sleep restriction therapy, a key component of CBT, which has the potential to be widely implemented. Methods: We did a pragmatic, superiority, open-label, randomised controlled trial of sleep restriction therapy versus sleep hygiene. Adults with insomnia disorder were recruited from 35 general practices across England and randomly assigned (1:1) using a web-based randomisation programme to either four sessions of nurse-delivered sleep restriction therapy plus a sleep hygiene booklet or a sleep hygiene booklet only. There was no restriction on usual care for either group. Outcomes were assessed at 3 months, 6 months, and 12 months. The primary endpoint was self-reported insomnia severity at 6 months measured with the insomnia severity index (ISI). The primary analysis included participants according to their allocated group and who contributed at least one outcome measurement. Cost-effectiveness was evaluated from the UK National Health Service and personal social services perspective and expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. The trial was prospectively registered (ISRCTN42499563). Findings: Between Aug 29, 2018, and March 23, 2020 we randomly assigned 642 participants to sleep restriction therapy (n=321) or sleep hygiene (n=321). Mean age was 55·4 years (range 19–88), with 489 (76·2%) participants being female and 153 (23·8%) being male. 580 (90·3%) participants provided data for at least one outcome measurement. At 6 months, mean ISI score was 10·9 (SD 5·5) for sleep restriction therapy and 13·9 (5·2) for sleep hygiene (adjusted mean difference –3·05, 95% CI –3·83 to –2·28; p<0·0001; Cohen's d –0·74), indicating that participants in the sleep restriction therapy group reported lower insomnia severity than the sleep hygiene group. The incremental cost per QALY gained was £2076, giving a 95·3% probability that treatment was cost-effective at a cost-effectiveness threshold of £20 000. Eight participants in each group had serious adverse events, none of which were judged to be related to intervention. Interpretation: Brief nurse-delivered sleep restriction therapy in primary care reduces insomnia symptoms, is likely to be cost-effective, and has the potential to be widely implemented as a first-line treatment for insomnia disorder. Funding: The National Institute for Health and Care Research Health Technology Assessment Programme.
Covid-19 trouble at work: A comparative qualitative analysis of disclosure, sickness absence and return-to-work in the UK, the USA, Australia and Japan
This paper addresses working people's narrated experiences of managing covid-related sickness in relation to employment. Bringing together the sociology of chronic illness and disability, and of work and organisations, we contribute to understandings of Covid-19 experiences in the context of employment. We draw from interview studies of Covid-19 infection and recovery in four countries, the UK, the USA, Australia and Japan. This cross-country comparative qualitative approach enables us to suggest how macrostructural regulatory and policy environments, and micropolitical environments of social interaction and moral evaluation shape paths between disclosure to employers, sick leave-taking, recovery and return to work after Covid-19 infection. For many of our participants across the four countries – especially those lacking in job security – this path was not straightforward, entailing intertwined moral and material risks. We draw out wider real-world implications, with regards to precarious work and limited governmental safety nets, and sociological implications in terms of un-flattening our analyses of how people encounter and dispose of trouble at work.
Perceptions of government guidance and citizen responses during the COVID-19 pandemic: A cross-country analysis
The public perception of government approaches to pandemic management has played an important role in citizen responses to the COVID-19 pandemic. Although the state and associated health institutions should feasibly be sources of epistemic authority, the pandemic has undermined their legitimacy as anti-science rhetoric proliferated and ‘fake news’ spread rapidly. In this paper, we present a comparative analysis of interviews with citizens across four different countries and explore how a lack of consistency and clarity in public health guidance from government and other trusted institutions led to a polarisation in public perceptions and mixed understandings of the pandemic. Using interview data collected across Brazil, Japan, Spain and the United Kingdom, we explored whether there were differences in the extent to which both state governments and scientific institutions were perceived as epistemic authorities through managing the pandemic. Participants grappled with a distrust of government guidelines, finding alternative sources of information to manage perceived infection risk, and make decisions around self-medication. Our analysis suggests several components were key to maintaining trust – and therefore epistemic authority – during the pandemic: reliability of the information delivered by different government bodies, including clarity of messaging; reliability of the government bodies themselves, including whether officials conducted themselves appropriately; and honesty about claims to expertise, including communicating when the scientific evidence was unclear or inconclusive. Our data suggests that honest communication about the limits of their knowledge would assist governments in engendering trust among citizens, and theoretically, compliance with public health guidelines.
Eliciting and prioritising determinants of improved care in multimorbidity: A modified online Delphi study
Background Multimorbidity is a major challenge to health and social care systems around the world. There is limited research exploring the wider contextual determinants that are important to improving care for this cohort. In this study, we aimed to elicit and prioritise determinants of improved care in people with multiple conditions. Methods A three-round online Delphi study was conducted in England with health and social care professionals, data scientists, researchers, people living with multimorbidity and their carers. Results Our findings suggest a care system which is still predominantly single condition focused. ‘Person-centred and holistic care’ and ‘coordinated and joined up care’, were highly rated determinants in relation to improved care for multimorbidity. We further identified a range of non-medical determinants that are important to providing holistic care for this cohort. Conclusions Further progress towards a holistic and patient-centred model is needed to ensure that care more effectively addresses the complex range of medical and non-medical needs of people living with multimorbidity. This requires a move from a single condition focused biomedical model to a person-based biopsychosocial approach, which has yet to be achieved.
Correction: Examining the absorption of post-internship medical officers into the public sector at county-level in devolved Kenya: a qualitative case study (BMC Health Services Research, (2023), 23, 1, (875), 10.1186/s12913-023-09928-0)
. Following publication of the original article [1], the authors identified errors in the affiliation assignment, caused by a typesetting mistake: affiliation 3 (instead of affiliation 2) was incorrectly assigned to Mike English as a second affiliation. This error is corrected in the affiliations list of this Correction article and the original article [1] has been updated.
Understanding Measurement of postural hypotension: a nationwide survey of primary care practice in England
BACKGROUND: Postural hypotension (PH), the drop in blood pressure (BP) on standing, is associated with falls, all-cause mortality and cognitive decline. PH diagnostic criteria require lying-to-standing BP measurements. PH Prevalence in older adults is 20%, however, it is infrequently recorded in primary care records, suggesting PH testing and/or recording is under-utilised in this setting. AIM: To understand current PH measurement and management by primary care practitioners in England. METHOD: Clinical Research Networks circulated an online survey to primary care clinicians involved in measurement of BP. Demographics and responses were summarised as percentages, or median and inter-quartile ranges (IQR), as appropriate. The survey remains open until 30 November 2022; full results will be presented at the conference. RESULTS: To date, there are 669 replies (341 doctors, 179 nurses, 70 healthcare assistants, 23 pharmacists, 56 other roles); median age 45 (IQR 38 to 53), 72% female. Overall, 597 (89%) responders check for PH, predominantly when symptoms are present (98%). Less common reasons to check include patients being over 80 (24%), Parkinson's disease (21%), hypertension reviews (18%), medication reviews (12%) or diabetes reviews (11%). Sitting-to-standing BP measurements are common (77%); only 22% use lying-to-standing. Only 64% ensure a rest period before sitting or lying BP measurement and only 1 (IQR 1 to 2) standing BP measurement is made, usually (66%) within the first minute of standing. CONCLUSION: Interim findings suggest that most PH assessments in primary care do not meet current guideline criteria. Full findings from this survey are expected to inform and influence future national guidelines.
Development and initial evaluation of a weight management programme tailored for people with serious mental illness: a non-randomised feasibility study with qualitative interviews
BEST ECR POSTER PRIZE 2022. People with serious mental illness (SMI) have higher rates of obesity and premature mortality due to cardiovascular disease (CVD) than the general population. Trials show behavioural weight management programmes (BWMPs) can help people with SMI lose weight and reduce the burden of CVD. However diagnostic- specific barriers to uptake and engagement are reported. We aimed to develop and evaluate a standard BWMP tailored for people with SMI – called ‘Weight cHange for people with sErious mEntal iLlness (WHEEL).’ The development comprised: 1) 12 patient and public contributors with SMI; 2) a systematic review of qualitative studies to identify programme characteristics that promote uptake and engagement for SMI; 3) a systematic review of trials testing BWMPs to identify which characteristics lead to weight loss; and 4) coding the effective characteristics against a standard 12-week BWMP to identify opportunities for tailored support. Initial evaluation comprised: 5) a non-randomised study of feasibility (retention and n, % of programme sessions attended) and acceptability (qualitative interviews plus self-reported weight loss) at end-of-programme. The programme developed was a weekly BWMP delivered by a commercial company. It was augmented with a one-off educational session geared towards people with SMI and weekly mentor check-ins. Seventeen participants (mean age: 48·52 years; 47% with schizophrenia) enrolled in the feasibility study and 16 were followed-up at 12-weeks (95% retention). All participants attended the educational session, 9/16 attended 50% of the weekly BWMP sessions, and 12/16 responded to 50% of the weekly check-ins. All participants reported weight loss (mean 4·06kg, SD: 3·17) and valued the novel education and therapeutic support. However anxious avoidance remained a barrier to joining the BWMP. This study showed initial evidence that a standard BWMP augmented with brief education and low-intensity support is feasible, acceptable, and may lead to weight loss in people with SMI.
COVID-19 vaccination hesitancy in people affected by diabetes and strategies to increase vaccine compliance: A systematic narrative review and meta-analysis.
INTRODUCTION: People affected by diabetes are at higher risk for complications from certain vaccine-preventable diseases. Suboptimal vaccination coverages are reported in this population sub-group. The purpose of this study is to estimate the proportion of diabetic patients who express hesitation to the COVID-19 vaccine worldwide. METHODS: Seven studies were included in the meta-analysis and systematic review, selected from scientific articles available in the MEDLINE/PubMed, Google Scholar and Scopus databases from 2020 to 2022. The following terms were used for the search strategy: (adherence OR hesitancy OR compliance OR attitude) AND (covid* OR SARS*) AND (vaccin* OR immun*) AND (diabet*). RESULTS: The vaccine hesitation rate among persons with diabetes was 27.8 % (95 %CI = 15.6-41.9 %). In the comparison of vaccine hesitancy between sexes and educational status, the RRs were 0.90 (95 %CI = 0.71-1.15) and 0.88 (95 %CI = 0.76-1.02), respectively. The main reasons of unwillingness were lack of information, opinion that the vaccine was unsafe or not efficient, and fear of adverse events. CONCLUSIONS: In order to achieve a high vaccination coverage, multifactorial approach is needed, which requires major social, scientific and health efforts. The success of the vaccination campaign in this population depends on the capillarity and consistency of the interventions implemented.
Integrated Management Systems (IMS) to Support and Sustain Quality One Health Services: International Lessons from the COVID-19 Pandemic by the IMIA Primary Care Working Group.
OBJECTIVES: One Health considers human, animal and environment health as a continuum. The COVID-19 pandemic started with the leap of a virus from animals to humans. Integrated management systems (IMS) should provide a coherent management framework, to meet reporting requirements and support care delivery. We report IMS deployment during, and retention post the COVID-19 pandemic, and exemplar One Health use cases. METHODS: Six volunteer members of the International Medical Association's (IMIA) Primary Care Working Group provided data about any IMS and One Health use to support the COVID-19 pandemic initiatives. We explored how IMS were: (1) Integrated with organisational strategy; (2) Utilised standardised processes, and (3) Met reporting requirements, including public health. Selected contributors provided Unified Modelling Language (UML) use case diagram for a One Health exemplar. RESULTS: There was weak evidence of synergy between IMS and health system strategy to the COVID-19 pandemic. However, there were rapid pragmatic responses to COVID-19, not citing IMS. All health systems implemented IMS to link COVID test results, vaccine uptake and outcomes, particularly mortality and to provide patients access to test results and vaccination certification. Neither proportion of gross domestic product alone, nor vaccine uptake determined outcome. One Health exemplars demonstrated that animal, human and environmental specialists could collaborate. CONCLUSIONS: IMS use improved the pandemic response. However, IMS use was pragmatic rather than utilising an international standard, with some of their benefits lost post-pandemic. Health systems should incorporate IMS that enables One Health approaches as part of their post COVID-19 pandemic preparedness.
Translation into arabic and validation of the patient assessment of care for chronic conditions questionnaire for diabetes
Background: The Patient Assessment of Care for Chronic Conditions (PACIC-5As) is a questionnaire developed in English and designed to evaluate the health care experiences of people living with chronic conditions such as diabetes. Aims: This study aimed to translate, culturally adapt and validate the PACIC-5As instrument for the Arab context in a sample of Saudi Arabian people with diabetes. Methods: The PACIC-5As was translated into Arabic using a forward and backward translation process. The Arabic version was then validated with a sample of 557 Saudi Arabians with diabetes who were recruited from tertiary level diabetes centres in Riyadh between January and March 2018. In order to evaluate the psychometric properties of the Arabic version, Cronbach alphas and item correlations were determined and exploratory factor analysis was performed. Results: The translated PACIC-5As had good psychometric quality. Cronbach alpha was > 0.9 and the inter-item correla-tion ranged between 0.36 and 0.56. Exploratory factor analysis showed a single-factor structure. Conclusion: An Arabic version of the PACIC-5As questionnaire is now available to assess the experience of patients with diabetes. The results of this study can be used to improve the quality of the delivery of health care in Arabic-speaking countries.
Digital home monitoring for capturing daily fluctuation of symptoms; a longitudinal repeated measures study: Long Covid Multi-disciplinary Consortium to Optimise Treatments and Services across the NHS (a LOCOMOTION study)
INTRODUCTION: A substantial proportion of COVID-19 survivors continue to have symptoms more than 3 months after infection, especially of those who required medical intervention. Lasting symptoms are wide-ranging, and presentation varies between individuals and fluctuates within an individual. Improved understanding of undulation in symptoms and triggers may improve efficacy of healthcare providers and enable individuals to better self-manage their Long Covid. We present a protocol where we aim to develop and examine the feasibility and usability of digital home monitoring for capturing daily fluctuation of symptoms in individuals with Long Covid and provide data to facilitate a personalised approach to the classification and management of Long Covid symptoms. METHODS AND ANALYSIS: This study is a longitudinal prospective cohort study of adults with Long Covid accessing 10 National Health Service (NHS) rehabilitation services in the UK. We aim to recruit 400 people from participating NHS sites. At referral to study, 6 weeks and 12 weeks, participants will complete demographic data (referral to study) and clinical outcome measures, including ecological momentary assessment (EMA) using personal mobile devices. EMA items are adapted from the COVID-19 Yorkshire Rehabilitation Scale items and include self-reported activities, symptoms and psychological factors. Passive activity data will be collected through wrist-worn sensors. We will use latent class growth models to identify trajectories of experience, potential phenotypes defined by co-occurrence of symptoms and inter-relationships between stressors, symptoms and participation in daily activities. We anticipate that n=300 participants provide 80% power to detect a 20% improvement in fatigue over 12 weeks in one class of patients relative to another. ETHICS AND DISSEMINATION: The study was approved by the Yorkshire & The Humber-Bradford Leeds Research Ethics Committee (ref: 21/YH/0276). Findings will be disseminated in peer-reviewed publications and presented at conferences. TRIAL REGISTRATION NUMBER: ISRCTN15022307.
Improving sleep after stroke: A randomised controlled trial of digital cognitive behavioural therapy for insomnia
Stroke is frequently accompanied by long-term sleep disruption. We therefore aimed to assess the efficacy of digital cognitive behavioural therapy for insomnia to improve sleep after stroke. A parallel group randomised controlled trial was conducted remotely in participant's homes/online. Randomisation was online with minimisation of between-group differences in age and baseline Sleep Condition Indicator-8 score. In total, 86 community-dwelling stroke survivors consented, of whom 84 completed baseline assessments (39 female, mean 5.5 years post-stroke, mean 59 years old), and were randomised to digital cognitive behavioural therapy or control (sleep hygiene information). Follow-up was at post-intervention (mean 75 days after baseline) and 8 weeks later. The primary outcome was self-reported insomnia symptoms, as per the Sleep Condition Indicator-8 (range 0–32, lower numbers indicate more severe insomnia, reliable change 7 points) at post-intervention. There were significant improvements in Sleep Condition Indicator-8 for digital cognitive behavioural therapy compared with control (intention-to-treat, digital cognitive behavioural therapy n = 48, control n = 36, 5 imputed datasets, effect of group p ≤ 0.02, (Formula presented.) = 0.07–0.12 [medium size effect], pooled mean difference = −3.35). Additionally, secondary outcomes showed shorter self-reported sleep-onset latencies and better mood for the digital cognitive behavioural therapy group, but no significant differences for self-efficacy, quality of life or actigraphy-derived sleep parameters. Cost-effectiveness analysis found that digital cognitive behavioural therapy dominates over control (non-significant cost savings and higher quality-adjusted life years). No related serious adverse events were reported to the researchers. Overall, digital cognitive behavioural therapy for insomnia effectively improves sleep after stroke. Future research is needed to assess earlier stages post-stroke, with a longer follow-up period to determine whether it should be included as part of routine post-stroke care. Clinicaltrials.gov NCT04272892.