Joanna Thorn’s research while affiliated with University of Bristol and other places

Background Respiratory tract infections (RTIs) are common in people in care homes. Transmission can be through direct contact or airborne particles. Portable high-efficiency-particulate-air (HEPA) filtration units remove airborne microbial particles, but it is unclear if this is sufficient to reduce infections. Objectives To investigate the effectiveness of portable HEPA filtration units to reduce RTIs in care home residents. Methods Ninety residential care homes were randomized to HEPA filtration units in communal rooms and private bedrooms or usual care. Primary outcome: number of RTIs recorded by care home staff. Secondary outcomes: other infections; falls/near falls; laboratory confirmed infections; hospitalizations; and staff sickness. Results A total of 43 care homes were randomized to intervention, 47 to usual care. Overall, 43% and 45% of intervention and control group care homes provided nursing care; 86% and 87% dementia care; and median (IQR) number of communal rooms were 4 (3–6) and 4 (3–5). A total of 1158 residents were consented, of whom 34 (3%) moved away; 172 (15%) died; and 5 stopped participating. Primary outcome data is 98% complete with 195 463 ‘resident days’ symptom data collected. Comparing intervention and control group residents: median (IQR) age was 87 (81–92) and 88 (82–92) years; 70% and 71% were female; 35% and 43% were receiving nursing care; 58% and 57% had dementia; frailty scores were 6 (4–7) and 6 (5–7); 95% and 94% received influenza vaccines; and 97% and 96% received COVID vaccines. Conclusions Full results will be available for conference. This global first RCT will provide invaluable evidence regarding the role of portable HEPA filtration to reduce RTIs in the care home setting.

Introduction Depression is three to four times more prevalent in autistic people and is related to reduced quality of life. There is a need for empirically supported psychological interventions for depression specifically adapted to meet the needs of autistic adults. ADEPT-2 aims to establish the clinical and cost-effectiveness of an adapted low-intensity psychological intervention (guided self-help) for depression in autistic adults. Methods and analysis A two parallel-group multicentre pragmatic randomised controlled trial investigating the effectiveness of GSH for depression in autistic adults. Participants (n=248) aged ≥18 years with a clinical diagnosis of autism currently experiencing depression will be randomised to GSH or treatment as usual (TAU). GSH is a low-intensity psychological intervention based on the principles of behavioural activation adapted for autism. GSH comprises informational materials for nine individual sessions facilitated online by a GSH coach who has received training and supervision in delivering the intervention. The primary outcome will be Beck Depression Inventory-II depression scores at 16 weeks post randomisation with follow-up measures at 32 and 52 weeks. Additional measures of anxiety, patient-rated global improvement, quality of life, work and social adjustment, positive and negative affect will be measured 16 and 52 weeks post randomisation. The primary health economic analysis will assess the cost-effectiveness of GSH compared with TAU over 52 weeks, from a societal perspective including the National Health Service, personal social services, personal expenses, voluntary services and productivity. An embedded qualitative study will explore the acceptability, experiences and adherence of participants and therapists to treatment principles. Ethics and dissemination This trial has been approved by the East of England - Essex Research Ethics Committee on 10 June 2022 (REC Reference number: 22/EE/0091). The findings of the research will be submitted for publication in peer-reviewed journals and disseminated in an appropriate format to trial participants and the wider public. Trial registration number ISRCTN17547011.

Context There is evidence that portable high-efficiency-particulate-air (HEPA) filtration units remove microbial particles from the air, but it is unclear whether this is sufficient to reduce infections in care home residents. Objectives To investigate the effectiveness of portable HEPA filtration units for winter respiratory infection episode reduction in care home residents. Study design and analysis: Cluster controlled trial with intention-to-treat analysis. Setting: 90 residential care homes for older adults in England. Population: Residents expected to reside in the care home for ≥1 month. Intervention care homes: Five HEPA filtration units in communal rooms and one HEPA filtration unit in 10 to 16 bedrooms. Control care homes: Usual care. Outcome measures: The primary outcome is the number of symptomatic winter respiratory infection episodes recorded by care home staff. Secondary outcomes: other infection measures; falls /near falls; laboratory confirmed infections; hospitalisations; and staff sickness. Process evaluation to assess intervention acceptability and implementation. Results Care homes were randomised between January 2022 and February 2024, 43 to intervention and 47 to usual care. Respectively, in intervention and control group care homes: 43% and 45% provided nursing care; 87% and 87% dementia care; and median (IQR) number of communal rooms were 4 (3-5) in both groups. 1126 residents were consented, of whom 31 (3%) moved away; 151 (13%) died; and 5 stopped participating. Primary outcome data is 98% complete with 175,318 'resident days' symptom data collected. Comparing intervention and control group residents: median (IQR) age was 88 (81-92) and 88 (82-92) years; 33% and 43% were receiving nursing care; 58% and 57% had dementia; frailty scores were 6 (4-7) and 6 (5-7); 94% and 94% received influenza; and 97% and 95% COVID vaccines. Conclusions Final analytic results of this world-first RCT will be available for the conference. Key messages • This world-first RCT using HEPA filters in care homes will report the evidence of effectiveness of respiratory infection episode reduction in care home residents. • The trial will inform policy makers about the effectiveness, acceptability and implementation of HEPA filters in care homes.

This paper considers the role of collective forms of day care for older people and their carers during the enforced closure of services in 2020 due to COVID-19. The study provides a unique opportunity to examine how the sector adapted to these unprecedented times. The paper draws on qualitative data collected from 8 case studies conducted in England, during which 120 interviews were held with older people, their carers, staff, and managers of services and local stakeholders. The findings demonstrate how day centres reimagined their services to meet the needs of older people and their carers in new and imaginative ways. They offer insights into the potential role day care centres could play in the new place-based partnerships envisaged in recent legislation. The study provides an opportunity to consider the importance of day care services in the light of their enforced closure, providing a more nuanced understanding of day care provision. The impact of COVID-19 on the social care sector meant that many day care centres were not fully operational and consequently the samples may not reflect the experiences of all centres.

Background Fatigue is a prevalent symptom in inflammatory rheumatic diseases (IRDs), leading to increased healthcare costs and productivity loss. Although NICE guidelines recommend psychological support from multidisciplinary rheumatology teams for fatigue management, there is significant variation in the treatment offered, and both patients and health professionals have expressed unmet needs in accessing fatigue therapy. Despite the proven benefits of many evidence-based therapeutic programmes for fatigue, they are not widely adopted in clinical practice. Health professionals report a lack of information on costs which may be a potential reason for this gap. Methods We developed a budget template in Microsoft Excel for rheumatology services to estimate costs tailored to their specific settings. This template is based on an earlier systematic review of 82 randomised controlled trials (RCTs) that are related to fatigue in IRDs. We screened studies from the review to identify interventions that significantly improved fatigue and had a sample size of 30 or more. Selected studies were categorised according to the type of intervention. Resource-related components of each intervention were extracted to serve as input variables for the template, including disease types covered by interventions, inclusion and exclusion criteria, intervention details (e.g., session number, duration), and staff pay band. Up-to-date staff costs were estimated using NHS pay bands and published sources of unit costs. Publications describing cost-effectiveness analyses conducted alongside the interventions described in the review were sought, and relevant cost data were also considered. The template was pre-populated with values referenced from the original RCT articles and Visual Basic functionality was used to compute summary costs. Input variables that users can use to customise in order to explore various scenarios were highlighted. Results Of the 82 studies included in the review, 48 RCTs met the criteria for inclusion in the budget template after screening. These RCTs were categorised into five groups: Physical activity or exercise (25 RCTs), Psychoeducational interventions (14 RCTs), Multicomponent interventions (3 RCTs), Consultations (3 RCTs), and Others (3 RCTs). Each intervention is available in a dropdown menu in the template, allowing users to select and subsequently adjust parameters as needed. The summary page of the template reports the average unit cost and total cost per patient for the selected intervention. Conclusion This template offers a method for service planners to estimate the potential costs of implementing different therapeutic programmes for fatigue in IRDs. Similar methods could be applied to other disease areas in future.

Background Respiratory tract infections are readily transmitted in care homes. Airborne transmission of pathogens causing respiratory tract illness is largely unmitigated. Portable high-efficiency-particulate-air (HEPA) filtration units capture microbial particles from the air, but it is unclear whether this is sufficient to reduce infections in care home residents. The Air Filtration to prevent symptomatic winter Respiratory Infections (including COVID-19) in care homes (AFRI-c) randomized controlled trial will determine whether using HEPA filtration units reduces respiratory infection episodes in care home residents. Methods AFRI-c is a cluster randomized controlled trial that will be delivered in residential care homes for older people in England. Ninety-one care homes will be randomised to take part for one winter period. The intervention care homes will receive HEPA filtration units for use in communal areas and private bedrooms. Normal infection control measures will continue in all care homes. Anonymised daily data on symptoms will be collected for up to 30 residents. Ten to 12 of these residents will be invited to consent to a primary care medical notes review and (in intervention homes) to having an air filter switched on in their private room. The primary outcome will be number of symptomatic winter respiratory infection episodes. Secondary outcomes include specific clinical measures of infection, number of falls / near falls, number of laboratory confirmed infections, hospitalisations, staff sickness and cost-effectiveness. A mixed methods process evaluation will assess intervention acceptability and implementation. Discussion The results of AFRI-c will provide vital information about whether portable HEPA filtration units reduce symptomatic winter respiratory infections in older care home residents. Findings about effectiveness, fidelity, acceptability and cost-effectiveness will support stakeholders to determine the use of HEPA filtration units as part of infection control policies.

Background Healthcare system data (HSD) are increasingly used in clinical trials, augmenting or replacing traditional methods of collecting outcome data. This study, PRIMORANT, set out to identify, in the UK context, issues to be considered before the decision to use HSD for outcome data in a clinical trial is finalised, a methodological question prioritised by the clinical trials community. Methods The PRIMORANT study had three phases. First, an initial workshop was held to scope the issues faced by trialists when considering whether to use HSDs for trial outcomes. Second, a consultation exercise was undertaken with clinical trials unit (CTU) staff, trialists, methodologists, clinicians, funding panels and data providers. Third, a final discussion workshop was held, at which the results of the consultation were fed back, case studies presented, and issues considered in small breakout groups. Results Key topics included in the consultation process were the validity of outcome data, timeliness of data capture, internal pilots, data-sharing, practical issues, and decision-making. A majority of consultation respondents (n = 78, 95%) considered the development of guidance for trialists to be feasible. Guidance was developed following the discussion workshop, for the five broad areas of terminology, feasibility, internal pilots, onward data sharing, and data archiving. Conclusions We provide guidance to inform decisions about whether or not to use HSDs for outcomes, and if so, to assist trialists in working with registries and other HSD providers to improve the design and delivery of trials.

Background Selective serotonin reuptake inhibitors (SSRIs) are commonly prescribed to manage anxiety in adults with an autism diagnosis. However, their effectiveness and adverse effect profile in the autistic population are not well known. This trial aims to determine the effectiveness and cost-effectiveness of the SSRI sertraline in reducing symptoms of anxiety and improving quality of life in adults with a diagnosis of autism compared with placebo and to quantify any adverse effects. Methods STRATA is a two-parallel group, multi-centre, pragmatic, double-blind, randomised placebo-controlled trial with allocation at the level of the individual. It will be delivered through recruiting sites with autism services in 4 regional centres in the United Kingdom (UK) and 1 in Australia. Adults with an autism diagnosis and a Generalised Anxiety Disorder Assessment (GAD-7) score ≥ 10 at screening will be randomised 1:1 to either 25 mg sertraline or placebo, with subsequent flexible dose titration up to 200 mg. The primary outcome is GAD-7 scores at 16 weeks post-randomisation. Secondary outcomes include adverse effects, proportionate change in GAD-7 scores including 50% reduction, social anxiety, obsessive-compulsive symptoms, panic attacks, repetitive behaviours, meltdowns, depressive symptoms, composite depression and anxiety, functioning and disability and quality of life. Carer burden will be assessed in a linked carer sub-study. Outcome data will be collected using online/paper methods via video call, face-to-face or telephone according to participant preference at 16, 24 and 52 weeks post-randomisation, with brief safety checks and data collection at 1–2, 4, 8, 12 and 36 weeks. An economic evaluation to study the cost-effectiveness of sertraline vs placebo and a QuinteT Recruitment Intervention (QRI) to optimise recruitment and informed consent are embedded within the trial. Qualitative interviews at various times during the study will explore experiences of participating and taking the trial medication. Discussion Results from this study should help autistic adults and their clinicians make evidence-based decisions on the use of sertraline for managing anxiety in this population. Trial registration ISRCTN, ISRCTN15984604. Registered on 08 February 2021. EudraCT 2019-004312-66. ANZCTR ACTRN12621000801819. Registered on 07 April 2021.

There is a widespread view amongst policy makers, as well as some senior managers and commissioners in local authorities, that collective forms of day care for older people are outdated and not aligned with wider policy ambitions. However, there is also growing recognition, amongst advocacy organisations such as Carers UK and Age UK, that many older people and their caregivers would welcome the opportunity to attend collective day care services, as well as growing interest amongst providers of services and older people themselves about the need to transform provision. As health and social care commissioners in England develop Integrated Care Systems, there is potential for reimagined day care for older people to play an important role in delivering person-centred, preventative and place-based care for older people and their caregivers, including enabling older people to live at home for longer as well as addressing wellbeing, loneliness and social isolation. The presentation will outline findings from case studies visited as part of a National Institute for Health Research, School for Social Care Research study exploring the experiences of and aspirations for collective day care in England, from the perspectives of older people, their carers, those who work in or manage services, as well as local stakeholders from the health and care system. For this research, day care is defined as community building-based services that provide care and/or health related services and/or clubs and activities specifically for older people (65+) with care and support needs. Case studies visited included a range of models of day care for older people including day centres for people living with dementia, small-scale day care based in a hosts home, to large-scale preventative provision for older people. The study explored: peoples experiences of attending; impact on wellbeing and health of older people and their caregivers; what an ideal model of day care would look like; experiences of day care through the COVID-19 pandemic; and relationships with local health and community partners. Our findings highlight the role day care can play in providing opportunities for connection and friendship for older people who attend, supporting caregivers to sustain their caring role, and supporting physical and mental wellbeing and health of older people and their caregivers. Highlighting the importance of personal connections, joy and purposeful activity, design of the physical space and connections with local place, the presentation will discuss innovations in practice that may support a ‘reimagining of day care’, ensuring it meets the aspirations of older people and their caregivers, as well as supporting wider policy ambitions including how social care services can contribute to the wider preventative health agenda.

Background: Selective serotonin reuptake inhibitors (SSRIs) are commonly prescribed to manage anxiety in adults with an autism diagnosis. However, their effectiveness and adverse effect profile in the autistic population is not well known. This trial aims to determine the effectiveness and cost-effectiveness of the SSRI sertraline in reducing symptoms of anxiety and improving quality of life in adults with a diagnosis of autism compared with placebo, and to quantify any adverse effects. Methods: STRATA is a two parallel group, multi-centre, pragmatic, double blind, randomised placebo-controlled trial with allocation at the level of the individual. It will be delivered through recruiting sites with autism services in 4 regional centres in the United Kingdom (UK) and 1 in Australia. Adults with an autism diagnosis and a Generalised Anxiety Disorder Assessment (GAD-7) score ≥10 at screening will be randomised 1:1 to either 25mg sertraline or placebo, with subsequent flexible dose titration up to 200mg. The primary outcome is GAD-7 scores at 16-weeks post-randomisation. Secondary outcomes include adverse effects, proportionate change in GAD-7 scores including 50% reduction, social anxiety, obsessive compulsive symptoms, panic attacks, repetitive behaviours, meltdowns, depressive symptoms, composite depression and anxiety, functioning and disability, and quality of life. Carer burden will be assessed in a linked carer sub-study. Outcome data will be collected using online/paper methods via video call, face-to-face or telephone according to participant preference at 16, 24- and 52-weeks post-randomisation, with brief safety checks and data collection at 1-2, 4, 8, 12 and 36 weeks. An economic evaluation to study cost-effectiveness of sertraline vs placebo, and a QuinteT Recruitment Intervention (QRI) to optimise recruitment and informed consent are embedded within the trial. Qualitative interviews at various times during the study will explore experiences of participating and taking the trial medication. Discussion: Results from this study should help autistic adults and their clinicians make evidence-based decisions on the use of sertraline for managing anxiety in this population. Trial registration: ISRCTN, ISRCTN15984604. Registered 08 February 2021, https://www.isrctn.com/ISRCTN15984604. EudraCT: 2019-004312-66. ANZCTR,ACTRN12621000801819. Registered 07 April 2021.