Search

Background: In early 2021, the Department of Health and Social Care in the UK called for research on the safety and immunogenicity of concomitant administration of COVID-19 and influenza vaccines. Co-administration of these vaccines would facilitate uptake and reduce the number of healthcare visits required. The ComFluCOV trial was designed to deliver the necessary evidence in time to inform the autumn (September–November) 2021 vaccination policy. This paper presents the statistical methodology applied to help successfully deliver the trial results in 6 months. Methods: ComFluCOV was a parallel-group multicentre randomised controlled trial managed by the Bristol Trials Centre. Two study statisticians, supported by a senior statistician, worked together on all statistical tasks. Tools were developed to aid the pre-screening process. Automated data monitoring reports of clinic data and electronic diaries were produced daily and reviewed by the trial team and feedback provided to sites. Analyses were performed independently in parallel, and derivations and results of all outcomes were compared. Results: Set-up was achieved in less than a month, and 679 participants were recruited over 8 weeks. A total of 537 [at least] daily reports outlining recruitment, protocol adherence, and data quality, and 695 daily reports of participant electronic diaries identifying any missed diary entries and adverse events were produced over a period of 16 weeks. A preliminary primary outcome analysis of validated data was reported to the Department of Health and Social Care in May 2021. The database was locked 6 weeks after the final participant follow-up and final analyses completed 3 weeks later. A pre-print publication was submitted within 14 days of the results being made available. The results were reported 6 months after first discussions about the trial. Conclusion: The statistical methodologies implemented in ComFluCOV helped to deliver the study in the timescale set. Working in a new clinical area to tight timescales was challenging. Having two statisticians working together on the study provided a quality assurance process that enabled analyses to be completed efficiently and ensured data were interpreted correctly. Processes developed could be applied to other studies to maximise quality, reduce the risk of errors, and overall provide enhanced validation methods. Trial registration: ISRCTN14391248, registered on 30 March 2021 [ABSTRACT FROM AUTHOR]

Background: Community-based volunteering supports outbreak management by extending reach into at-risk communities. This paper examines the application of a 'community champions' model in England, UK, during the COVID-19 pandemic. Evidence pre-pandemic shows that community champion interventions tap into social networks to strengthen connections with disadvantaged communities. During the pandemic, the UK government set up a COVID community champions funding award scheme for local authorities to develop local programmes that addressed emerging inequalities. The study aim was to identify transferable learning on community engagement in the pandemic by undertaking a secondary qualitative synthesis of practice-based case studies of local COVID community champion programmes. Methods: A systematic staged approach for synthesis of practice-based case studies was used. In total, 16 COVID community champion case studies, which were written by practitioners involved in local programme implementation and published by the Local Government Association, were included. Case studies covered aims, programme development and delivery, examples of activities and a discussion of learning. Framework qualitative analysis methods were used to code and organise data prior to cross case analysis. The final stage produced an overarching thematic framework that best represented descriptive and interpretive themes. Results: The results provide an overview of common features of COVID community champion programmes and emergent learning. All local programmes aimed to reduce health inequalities by involving at-risk communities in local prevention efforts, adapting the approach to local priorities. Two levels of community engagement were volunteer mobilisation and subsequent community-based outreach activities. Elements of capacity building, such as training and creation of networks, were common. The synthesis of practice-based learning found that stronger relationships with communities were regarded as a key mechanism to support more equitable prevention strategies. Other learning themes related to champion roles, community engagement strategies and programme implementation. Conclusions: By focusing on how community champion approaches were applied by local authorities in England during the COVID-19 pandemic, this study contributes to knowledge on volunteer mobilisation as a mechanism to improve public health communication and outreach. Notwithstanding the limitations of experiential evidence, the synthesis of practice-based learning highlights potentially transferable community engagement strategies for health protection and health improvement. [ABSTRACT FROM AUTHOR]

Background: Testing positive for COVID-19 was associated with higher rates of detrimental psycho-social and physical health outcomes. The COVID-19 pandemic caused unprecedented disruption to everyday life. This included major reconfiguration of maternal, child, and perinatal mental health and care services and provision. This study aimed to investigate the experiences of those who tested positive for COVID-19 during pregnancy, labour and birth, or the early postnatal period. Methods: National on-line recruitment from across the United Kingdom resulted in sixteen mothers being invited to qualitative semi-structured interviews to understand the experiences of mothers who had been infected by COVID-19 during pregnancy, labour and birth, or the early postnatal period. Interviews were conducted, recorded, and transcribed using video-conferencing software. A Grounded Theory approach was used to analyse the data gathered pertaining to women's experiences of their positive COVID-19 diagnosis during pregnancy, labour and birth, or the early postnatal period. Results: The theory of 'Oscillating Autonomy – Losing and Seeking to Regain Control by Striving for Agency' was developed, comprising three main themes: 'Anxious Anticipation: The fear of infection was worse than COVID-19 itself'; 'Fluctuating Agency: What changed when COVID-19 took control'; and 'Reclaiming Control: Seeking reassurance during COVID-19 positivity'. Testing positive for COVID-19 whilst pregnant, during labour or birth, or in the early postnatal period was associated with a perceived loss of control. Those who were able to regain that control felt more secure in their situation. Conclusions: Support was paramount to manage increased vulnerability, as was reassurance achieved by information seeking and positive action including increased health monitoring and COVID-19 vaccination. [ABSTRACT FROM AUTHOR]

Background: The sudden introduction of social distancing measures in response to the COVID-19 pandemic resulted in significant lifestyle changes for the UK population. People living with physical disabilities were deemed to be at greater risk of complications following COVID-19 infection and were subjected to stricter social distancing guidelines. But gaps remain in our understanding of how the COVID-19 pandemic and associated restrictions affected the ability to access support, health and wellbeing of people with physical disabilities. Such understanding is vital to ensure equitable future pandemic preparedness for people living with physical disabilities. Methods: We conducted qualitative semi-structured interviews with 31 people living in the UK between May 2020 and January 2022. All participants self-identified as having a physical disability that affected their mobility, sight, or hearing. We analysed the data using reflexive thematic analysis. Results: Six themes were identified that described the impact of the pandemic on ability to access support, health and wellbeing: (i) adaptations to healthcare provision led to difficulties in managing health and wellbeing; (ii) exacerbations of inequalities in access to public space due to social distancing guidelines; (iii) experiences of hostility from able-bodied people; (iv) loss of social lives and encounters; (v) difficulties maintaining distance from others and subsequent fear of infection and (vi) strategies to support wellbeing and coping when confined to the home. Conclusion: The COVID-19 pandemic exacerbated existing health and social inequalities experienced by disabled people. The disproportionate impact of the pandemic on service provision and social connections resulted in challenging circumstances for disabled people who faced unmet medical needs, deteriorating health, and at times, hostile public spaces. Disabled people's experiences need to be incorporated into future pandemic or health-related emergency planning to ensure equality of access to services and public spaces to ensure their health and wellbeing is supported and maintained. [ABSTRACT FROM AUTHOR]

Background: There are clear inequalities in COVID − 19 vaccination rates amongst marginalised groups, with lower rates for some minoritised ethnic and religious groups, younger people, those living in more deprived areas, and with lower socio-economic status. Existing research focuses on psychological and socio-economic factors that influence vaccine uptake and does not explore broader social and historical contexts. Understanding inequalities in COVID-19 vaccine uptake requires a critical examination of the drivers of, and barriers to, vaccination. Methods: We present findings from a co-designed qualitative research study undertaken during the COVID-19 pandemic. Focus groups and interviews were used to examine the context underpinning responses to the COVID-19 vaccination in Greater Manchester, particularly focussing on experiences of marginalisation. Thematic framework analysis was used to analyse the data. Results: We found that the public's responses to the COVID-19 vaccination programme are intertwined with a longstanding history of institutional distrust and disenfranchisement, resulting from experiences of marginalisation and social inequalities. This was exacerbated further by the disproportionate impacts of the COVID-19 pandemic on minoritised ethnic groups, younger people, and those with existing health conditions. Conclusions: Histories of structural inequalities experienced by minoritised groups invoked feelings of suspicion and scepticism at the motivations of the agencies behind the vaccination rollout. This highlights the need for a contextualised analysis of attitudes to vaccines, considering pre-existing inequalities, which may be especially relevant for conceptualising public responses to the vaccination programme. Finally, our study shows the important ways in which public (dis)trust can impact public health policies. We recommend this should be incorporated into responses to future public health crises. [ABSTRACT FROM AUTHOR]

Background: Several studies have reported the association between dietary inflammatory index (DII) and the SARS-CoV-2 infection risk, severity or mortality of COVID-19, however, the outcomes remain controversial. Objective: We sought to examine whether a dose-response association of DII and SARS-CoV-2 infection exists. Design: A dose-response meta-analysis was performed to investigate the association of DII and SARS-CoV-2 infection. We conducted a systematic search of PubMed, Embase and Web of Science up to March 15th, 2023. The odds ratios (OR) of DII and COVID-19 risk and severity were computed. Results: Totally, 5 studies were included (1 from UK and 4 from Iran), consisting of 197,929 participants with 12,081 COVID-19 cases. Although there was heterogeneity among studies, the results indicated that higher DII was independently related to higher SARS-CoV-2 infection incidence (OR = 1.57, 95% CI: 1.14, 2.17) and COVID-19 severity (OR = 1.11, 95% CI: 1.07, 1.15) but not COVID-19 mortality (risk ratio = 1.13, 95% CI: 1.00, 1.27). The incidence of SARS-CoV-2 infection increased by 31% for each 1-point increase in the E-DII (OR = 1.31, 95% CI: 1.20, 1.43). Conclusions: This meta-analysis suggests that an elevated DII score is associated with increased SARS-CoV-2 infectious risk and severity of COVID-19. There were not enough studies on COVID-19 mortality. Further large prospective studies in different countries are warranted to validate our results. [ABSTRACT FROM AUTHOR]

Background: Developments in digital health have the potential to create new opportunities for healthcare professionals support delivery of palliative care. Globally, many palliative care professionals used digital health innovations to support communication with staff, patients and caregivers, during COVID-19 pandemic. However, there is limited data about the views of palliative care professionals of using digital health to support communication during the pandemic. We aimed to describe how palliative care professionals used technology to support communication (multidisciplinary team working, education and with patients and family caregivers) during the COVID-19 pandemic. Method(s): UK based palliative care healthcare professionals completed an electronic questionnaire to describe their use of digital health, during the COVID-19 pandemic, to support (1) communication within the multidisciplinary team (MDT), (2) education and (3) to support communication with patients and carers. Results: Two hundred and thirty-four palliative care professionals participated. Most (n = 227, 97%) described an increase in their use of digital health, to support communication, since the start of the COVID-19 pandemic. We identified benefits and challenges for digital health communication, which we summarised into themes, including 'a new way of working', 'developing a new approach to learning' and 'impacting care'. Conclusion(s): Since the pandemic, palliative care professionals have increased their use of digital health to support communication in clinical practice. We have identified facilitators and barriers for future practice. Further work should identify the levels of support needed for organisations to ensure that digital health interventions are meaningfully used to help palliative care professionals effectively communicate with patients, caregivers and staff. [ABSTRACT FROM AUTHOR]

Background: Empathy is widely recognised as an important element of medical practice contributing to patient outcomes and satisfaction. It is also an important element of collaborative work in a healthcare team. However, there is evidence to suggest that empathy towards patients declines over time, particularly in surgical specialities. There is little qualitative research on this decline in surgical trainees, particularly in the UK. Therefore, the aim of this study was to explore how trainee surgeons experience empathy over the course of their career, both towards patients and colleagues and how they perceive it in others. Methods: 10 semi-structured interviews were carried out with surgical trainees of different grades and specialties in January and February 2022. Framework analysis was used to interpret the data. Results: Participants experienced an evolution in empathy over their career as their personal and professional experience was added to. They drew a distinction between desensitisation and actual decline in empathy and identified more with experiencing the former in their careers. Participants also felt interprofessional relationships require empathy, and this could be improved upon. Finally, they highlighted specific impacts of the COVID-19 pandemic upon their training, including reduced theatre time. Conclusions: Participants felt training could be improved in regard to accessing training opportunities and relationships with colleagues, although many felt empathy between colleagues is better than it has been in the past. This project highlighted areas for future research, such as with surgeons in later stages of their careers, or mixed-methods projects. [ABSTRACT FROM AUTHOR]

Background: The NIHR's Associate Principal Investigator (API) Scheme in the United Kingdom was expanded nationally in 2020 with the aim of training clinicians to become Principal Investigators for clinical research in the future. The HEAL-COVID adaptive platform trial is an urgent public health study registered with the API Scheme. Within eighteen months of opening, the trial had recruited almost 1200 patients with over 100 active sites. Here we describe our experiences of APIs working on the trial with two broad objectives. Firstly, we aim to explore through qualitative methods the impact that the scheme has had on the APIs' professional development. Secondly, we aim to quantify the impact that the APIs have had on the recruitment of patients into the trial. Methods: The professional backgrounds of the APIs are described from data from their application forms to the scheme. The HEAL-COVID API Network is described from records of the monthly meetings. The APIs' experiences are reviewed from data from the NIHR exit surveys at 6 months and from a reflective practice exercise at the final network meeting. Data of patient recruitment to HEAL-COVID was analysed for centres with and without APIs via a multivariate analysis. Results: Forty-two APIs were registered with the HEAL-COVID trial with a diversity of backgrounds in terms of gender, country, profession, grade and specialty. Eleven monthly network meetings took place with the dual objectives of facilitating trial activity and providing educational content. Fourteen APIs completed the NIHR survey with all reporting Good Clinical Practice completion, local promotional activity of the trial, patient recruitment and support from their respective PI. Sites with at least one API recruited over 3.5 times more patients than sites without an API (medians 4 vs 14.5, p < 0.05), independent of factors including type of hospital or number of inpatient beds. Discussion: This study adds to the growing literature that the NIHR's API Scheme is effective in meeting its objectives in providing research training to clinicians, thus building a workforce of future clinical researchers. Moreover, data from the HEAL-COVID trial shows that sites with an API are associated with higher recruitment. Overall, registering a trial with the API Scheme not only trains future clinical researchers, but it is also likely to increase the number of patients recruited (amongst other benefits), increasing the efficiency of trials and improving access for patients. [ABSTRACT FROM AUTHOR]

Background: Previous Mendelian studies identified a causal relationship between renal function, as assessed by estimated glomerular filtration rate (eGFR), and severe infection with coronavirus disease 2019 (COVID-19). However, much is still unknown because of the limited number of associated single nucleotide polymorphisms (SNPs) of COVID-19 and the lack of cystatin C testing. Therefore, in the present study, we aimed to determine the genetic mechanisms responsible for the association between eGFR and COVID-19 in a European population. Methods: We performed bidirectional Mendelian randomization (MR) analysis on large-scale genome-wide association study (GWAS) data; log-eGFR was calculated from the serum levels of creatinine or cystatin C by applying the Chronic Kidney Disease Genetics (CKDGen) Meta-analysis Dataset combined with the UK Biobank (N = 1,004,040) and on COVID-19 phenotypes (122,616 COVID-19 cases and 2,475,240 controls) from COVID19-hg GWAS meta-analyses round 7. The inverse-variance weighted method was used as the main method for estimation. Results: Analyses showed that the genetically instrumented reduced log-eGFR, as calculated from the serum levels of creatinine, was associated with a significantly higher risk of severe COVID-19 (odds ratio [OR]: 2.73, 95% confidence interval [CI]: 1.38–5.41, P < 0.05) and significantly related to COVID-19 hospitalization (OR: 2.36, 95% CI: 1.39–4.00, P < 0.05) or infection (OR: 1.24, 95% CI: 1.01–1.53, P < 0.05). The significance of these associations remained when using log-eGFR based on the serum levels of cystatin C as genetically instrumented. However, genetically instrumented COVID-19, regardless of phenotype, was not related to log-eGFR, as calculated by either the serum levels of creatinine or cystatin C. Conclusions: Our findings suggest that genetical predisposition to reduced kidney function may represent a risk factor for COVID-19. However, a consistent and significant effect of COVID-19 on kidney function was not identified in this study. [ABSTRACT FROM AUTHOR]

Background: People with severe COVID anxiety have poor mental health and impaired functioning, but the course of severe COVID anxiety is unknown and the quality of evidence on the acceptability and impact of psychological interventions is low. Methods: A quantitative cohort study with a nested feasibility trial. Potential participants aged 18 and over, living in the UK with severe COVID anxiety, were recruited online and from primary care services. We examined levels of COVID anxiety in the six months after recruitment, and factors that influenced this, using linear regression. Those scoring above 20 on the short Health Anxiety Inventory were invited to participate in a feasibility trial of remotely delivered Cognitive Behavioural Therapy for Health Anxiety (CBT-HA). Exclusion criteria were recent COVID-19, current self-isolation, or current receipt of psychological treatment. Key outcomes for the feasibility trial were the level of uptake of CBT-HA and the rate of follow-up. Results: 204 (70.2%) of 285 people who took part in the cohort study completed the six month follow-up, for whom levels of COVID anxiety fell from 12.4 at baseline to 6.8 at six months (difference = -5.5, 95% CI = -6.0 to -4.9). Reductions in COVID anxiety were lower among older people, those living with a vulnerable person, those with lower baseline COVID anxiety, and those with higher levels of generalised anxiety and health anxiety at baseline. 36 (90%) of 40 participants enrolled in the nested feasibility trial were followed up at six months. 17 (80.9%) of 21 people in the active arm of the trial received four or more sessions of CBT-HA. We found improved mental health and social functioning among those in the active, but not the control arm of the trial (Mean difference in total score on the Work and Social Adjustment Scale between baseline and follow up, was 9.7 (95% CI = 5.8–13.6) among those in the active, and 1.0 (95% C.I. = -4.6 to 6.6) among those in the control arm of the trial. Conclusions: While the mental health of people with severe COVID anxiety appears to improve over time, many continue to experience high levels of anxiety and poor social functioning. Health anxiety is highly prevalent among people with severe COVID anxiety and may provide a target for psychological treatment. Trial registration: Retrospectively registered at ISRCTN14973494 on 09/09/2021. [ABSTRACT FROM AUTHOR]

Background: Young carers are children or young people aged up to 25 years old who undertake unpaid caring responsibilities for a friend or family member. Young carers faced significant challenges brought on by the COVID-19 pandemic. We explored the impact of the pandemic and associated restrictions on mental health, wellbeing and access to support in young carers in the United Kingdom (UK) to understand how to improve services, as well as support this population in future health emergencies. Method: We conducted 22 qualitative semi-structured interviews from May to November 2021 with 14 young carers and eight staff working in organisations that supported them. Interviews took place remotely over video or telephone call and explored participant experiences of the pandemic and its impact on their health, wellbeing and caring responsibilities. We used reflexive thematic analysis to analyse interview transcripts. Results: We identified four overarching themes pertaining to the impact of the pandemic and associated restrictions on mental health, wellbeing and access to support in young carers in the UK: (1) challenges in protecting loved ones from the virus, (2) changes to and loss of routine, (3) reduced access to pre-pandemic informal and formal support structures and (4) better understanding of inner resilience and goals. Many participants struggled with their mental health and wellbeing as a result of pandemic related restrictions which impacted on support structures for themselves and the individual they cared for. However, positive impacts pertained to additional support provided by local authority and third sector organisations. Conclusions: Our findings highlight some of the changes that affected young carers during the COVID-19 pandemic. The impact of changes to routine and a reduction in pre-pandemic support were the greatest concerns reported by participants in this study. The additional support provided by local authority and third sector organisations during social restrictions suggests such organisations could play a greater role in supporting this population going forward and that schools and Governments may wish to put in additional strategies and provisions to protect young carers in the future. [ABSTRACT FROM AUTHOR]