Jackson et al (2020) have recently described the extraordinary times we face as a result of the Covid‐19 pandemic. As we write, the number of cases and the associated mortality continues to rise. In the United Kingdom (UK) a number of ‘Nightingale Hospitals’ have been constructed within large arenas. Clinical staff who have recently left National Health Service (NHS) are being asked to return to practice to support the rapidly escalating numbers of patients, and nursing students from year two of their degree programme onwards are being asked to opt‐in to an extended placement working to further bolster the numbers of care staff available.
Individuals with minimal disability from multiple sclerosis (MS) requested advice on finding the right balance, between too much and too little exercise, when participating in their choice of sport or exercise. To optimise exercise participation during the early stages of the disease, a flexible exercise participation programme (FEPP) has been developed. The FEPP is novel because it provides guidance and support for individuals with MS to participate and progress in their preferred sport or exercise. The primary objective was to assess the feasibility of the FEPP. The secondary objective was to assess the feasibility of a larger trial to demonstrate the efficacy of the FEPP.
A stage I feasibility study of the FEPP, using a single group preintervention/post-intervention design, will be conducted with 16 participants with minimal disability from MS (Expanded Disability Status Scale level of 0–3.5). The 12-week FEPP will guide participants to independently participate in their preferred sport or exercise at a location of their choice. Exercise progression will be guided by individual energy levels and a weekly telephone coaching session with a physiotherapist. Participation in exercise or sport will be recorded in parallel with assessment of disease biomarkers (plasma cytokines interleukin (IL)-2, IL-4, IL-6, IL-10, interferon (IFN)- and tumour necrosis factor (TNF)), subjective vitality and high-level mobility. Acceptability of the FEPP will be assessed using a sequential explanatory mixed methods design where the findings of a participant survey will inform the interview guide for a series of focus groups.
Feasibility of a larger trial will be assessed via process, resources, management and scientific metrics. Progression to a larger trial will depend on the achievement of specified minimum success criteria.
Ethical approval has been obtained for this study from the James Cook University Human Research Ethics Committee (H7956). Dissemination of findings is planned via peer-reviewed journals, conference presentations and media releases. The protocol date was 21 December 2019, V.1.
The trial is registered with Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12620000076976.
Severe behavioural problems (SBPs) are a common contributor to morbidity and reduced quality of life in children with intellectual disability (ID). Current medication treatment for SBP is associated with a high risk of side effects. Innovative and safe interventions are urgently needed. Anecdotal reports and preliminary research suggest that medicinal cannabis may be effective in managing SBP in children with developmental disabilities. In particular, cannabidiol (CBD) may be a plausible and safe alternative to current medications. Families who are in urgent need of solutions are seeking cannabis for their ID children with SBP. However there is no evidence from randomised controlled trials to support the use of CBD for SBP. This pilot study aims to investigate the feasibility of conducting a randomised placebo-controlled trial of CBD to improve SBP in children with ID.
This is a single-site, double-blind, parallel-group, randomised, placebo-controlled pilot study of 10 participants comparing 98% CBD oil with placebo in reducing SBP in children aged 8–16 years with ID. Eligible participants will be randomised 1:1 to receive either CBD 20 mg/kg/day or placebo for 8 weeks. Data will be collected regarding the feasibility and acceptability of all study components, including recruitment, drop-out rate, study visit attendance, protocol adherence and the time burden of parent questionnaires. Safety outcomes and adverse events will be recorded. All data will be reported using descriptive statistics. These data will inform the design of a full scale randomised controlled trial to evaluate the efficacy of CBD in this patient group.
This protocol has received ethics approval from the Royal Children’s Hospital ethics committee (Human Research Ethics Committee no. 38236). Results will be disseminated through peer-reviewed journals, professional networks, conferences and social media.
We aimed to develop a digital intervention to support antidepressant discontinuation in UK primary care that is scalable, accessible, safe and feasible. In this paper, we describe the development using a theory, evidence and person-based approach.
Intervention development using a theory, evidence and person-based approach.
Primary Care in the South of England.
Fifteen participants with a range of antidepressant experience took part in ‘think aloud’ interviews for intervention optimisation.
Our digital intervention prototype (called ‘ADvisor’) was developed on the basis of a planning phase consisting of qualitative and quantitative reviews, an in-depth qualitative study, the development of guiding principles and a theory-based behavioural analysis. Our optimisation phase consisted of ‘think aloud’ interviews where the intervention was iteratively refined.
The qualitative systematic review and in-depth qualitative study highlighted the centrality of fear of depression relapse as a key barrier to discontinuation. The quantitative systematic review showed that psychologically informed approaches such as cognitive–behavioural therapy were associated with greater rates of discontinuation than simple advice to reduce. Following a behavioural diagnosis based on the behaviour change wheel, social cognitive theory provided a theoretical basis for the intervention. The intervention was optimised on the basis of think aloud interviews, where participants suggested they like the flexibility of the system and found it reassuring. Changes were made to the tone of the material and the structure was adjusted based on this qualitative feedback.
‘ADvisor’ is a theory, evidence and person-based digital intervention designed to support antidepressant discontinuation. The intervention was perceived as helpful and reassuring in optimisation interviews. Trials are now needed to determine the feasibility, clinical and cost-effectiveness of this approach.
To gain insight into the supportive care needs of Western Australian women experiencing gynaecological cancer.
Meeting the supportive care needs of people living with cancer is becoming increasingly important as advances in cancer treatment contribute to growing numbers of survivors. International evidence suggests between 24%–56% of women with gynaecological cancer have unmet supportive care needs and that psychological challenges, information provision and holistic care are priorities. No qualitative investigation has previously explored women's journey of gynaecological cancer within the Australian setting.
A qualitative descriptive design was used.
Women treated for gynaecological cancer were recruited from a tertiary public women's hospital in Western Australia. Thematic analysis was conducted on qualitative data collected from 190 women over 12 months through written open‐ended survey responses and telephone interviews. The COnsolidated criteria for REporting Qualitative research (COREQ) guided presentation of results.
Analysis yielded five themes and four subthemes: (a) Communication style directs the experience (subthemes: feeling supported; absence of empathy); (b) It's not just about the disease (subthemes: life has changed; holistic care); (c) A desire for information; (d) Drawing upon resilience; and (e) Navigating the system.
Exploration of the women's needs leads to the discussion of three concepts. Communication styles, harnessing women's resilience and alternative models of care are evaluated for their capacity to improve care and women's quality of life into survivorship. Recommendations are made for further research and possible interventions that can be translated into the clinical setting.
Women with gynaecological cancer described complex often unmet supportive care needs and interactions with the healthcare system. Insight gained directs suggestions for improved service provision.
Improved patient‐centred communication, harnessing resilience as a resource and alternative models of care for follow‐up are encouraged as areas of improvement for clinicians and care services.
Little is known about the bone health of adults with bipolar disorder, aside from evidence purporting bone deficits among individuals with other mental illnesses, or those taking medications commonly used in bipolar disorder. In this paper, we present the methodology of a case–control study which aims to examine the role of bipolar disorder as a risk factor for bone fragility.
Men and women with bipolar disorder (~200 cases) will be recruited and compared with participants with no history of bipolar disorder (~1500 controls) from the Geelong Osteoporosis Study. Both cases and controls will be drawn from the Barwon Statistical Division, south-eastern Australia. The Structured Clinical Interview for DSM-IV-TR Research Version, Non-patient edition is the primary diagnostic instrument, and psychiatric symptomatology will be assessed using validated rating scales. Demographic information and detailed lifestyle data and medical history will be collected via comprehensive questionnaires. Participants will undergo dual energy X-ray absorptiometry scans and other clinical measures to determine bone and body composition. Blood samples will be provided after an overnight fast and stored for batch analysis.
Ethics approval has been granted from Barwon Health Research Ethics Committee. Participation in the study is voluntary. The study findings will be disseminated via peer-reviewed publications, conference presentations and reports to the funding body.
This study examined the association of anxiety alone, depression alone and the presence of both anxiety and depression with preterm birth (PTB) and further examined whether neighbourhood socioeconomic status (SES) modified this association.
Cohort study using individual-level data from two community-based prospective pregnancy cohort studies (All Our Families; AOF) and Alberta Pregnancy Outcomes and Nutrition (APrON) and neighbourhood SES data from the 2011 Canadian census.
Calgary, Alberta, Canada.
Overall, 5538 pregnant women who were 15 years old were enrolled in the cohort studies between 2008 and 2012. 3341 women participated in the AOF study and 2187 women participated in the APrON study, with 231 women participated in both studies. Women who participated in both studies were only counted once.
PTB was defined as delivery prior to 37 weeks of gestation. Depression was defined as an Edinburgh Postnatal Depression Scale (EPDS) score of ≥13, anxiety was defined as an EPDS-anxiety subscale score of ≥6, and the presence of both anxiety and depression was defined as meeting both anxiety and depression definitions.
Overall, 7.3% of women delivered preterm infants. The presence of both anxiety and depression, but neither of these conditions alone, was significantly associated with PTB (OR 1.6, 95% CI 1.1 to 2.3) and had significant interaction with neighbourhood deprivation (p=0.004). The predicted probability of PTB for women with both anxiety and depression was 10.0%, which increased to 15.7% if they lived in the most deprived neighbourhoods and decreased to 1.4% if they lived in the least deprived neighbourhoods.
Effects of anxiety and depression on risk of PTB differ depending on where women live. This understanding may guide the identification of women at increased risk for PTB and allocation of resources for early identification and management of anxiety and depression.
People with long-term conditions typically have reduced physical functioning, are less physically active and therefore become less able to live independently and do the things they enjoy. However, assessment and promotion of physical function and physical activity is not part of routine management in primary care. This project aims to develop evidence-based recommendations about how primary care can best help people to become more physically active in order to maintain and improve their physical function, thus promoting independence.
This study takes a realist synthesis approach, following RAMESES guidance, with embedded co-production and co-design. Stage 1 will develop initial programme theories about physical activity and physical function for people with long-term conditions, based on a review of the scientific and grey literature, and two multisector stakeholder workshops using LEGO® SERIOUS PLAY®. Stage 2 will involve focused literature searching, data extraction and synthesis to provide evidence to support or refute the initial programme theories. Searches for evidence will focus on physical activity interventions involving the assessment of physical function which are relevant to primary care. We will describe ‘what works’, ‘for whom’ and ‘in what circumstances’ and develop conjectured programme theories using context, mechanism and outcome configurations. Stage 3 will test and refine these theories through individual stakeholder interviews. The resulting theory-driven recommendations will feed into Stage 4 which will involve three sequential co-design stakeholder workshops in which practical ideas for service innovation in primary care will be developed.
Healthcare and Medical Sciences Academic Ethics Committee (Reference 2018-16308) and NHS Wales Research Ethics Committee 5 approval (References 256 729 and 262726) have been obtained. A knowledge mobilisation event will address issues relevant to wider implementation of the intervention and study findings. Findings will be disseminated through peer-reviewed journal publications, conference presentations and formal and informal reports.
Randomised controlled trials in healthcare increasingly include economic evaluations. Some show small differences which are not statistically significant. Yet these sometimes come to paradoxical conclusions such as: ‘the intervention is not clinically effective’ but ‘is probably cost-effective’. This study aims to quantify the extent of non-significant results and the types of conclusions drawn from them.
Cross-sectional retrospective analysis of randomised trials published by the UK’s National Institute for Health Research (NIHR) Health Technology Assessment programme. We defined as ‘doubly null’ those trials that found non-statistically significant differences in both primary outcome and cost per patient. Paradoxical was defined as concluding in favour of an intervention, usually compared with placebo or usual care. No human participants were involved. Our sample was 226 randomised trial projects published by the Health Technology Assessment programme 2004 to 2017. All are available free online.
The 226 projects contained 193 trials with a full economic evaluation. Of these 76 (39%) had at least one ‘doubly null’ comparison. These 76 trials contained 94 comparisons. In these 30 (32%) drew economic conclusions in favour of an intervention. Overall report conclusions split roughly equally between those favouring the intervention (14), and those favouring either the control (7) or uncertainty (9).
Trials with ‘doubly null’ results and paradoxical conclusions are not uncommon. The differences observed in cost and quality-adjustedlife year were small and non-statistically significant. Almost all these trials were also published in leading peer-reviewed journals. Although some guidelines for reporting economic results require cost-effectiveness estimates regardless of statistical significance, the interpretability of paradoxical results has nowhere been addressed.
Reconsideration is required of the interpretation of cost-effectiveness analyses in randomised controlled trials with ‘doubly null’ results, particularly when economics favours a novel intervention.
The economic cost of osteoarthritis (OA) is high. At least 4.4 million people have hand OA in the UK. Symptomatic thumb base OA affects 20% of people over 55 years, causing more pain, work and functional disability than OA elsewhere in the hand. Most evidence-based guidelines recommend splinting for hand OA. Splints that support or immobilise the thumb base are routinely used despite there being limited evidence on their effectiveness. The potential effects of placebo interventions in OA are acknowledged, but few studies investigate the clinical efficacy of rehabilitation interventions nor the impact of any placebo effects associated with splints.
Participants aged 30 years and over with symptomatic thumb base OA will be recruited into the trial from secondary care occupational therapy and physiotherapy centres. Following informed consent, participants will complete a baseline questionnaire and then be randomised into one of three treatment arms: a self-management programme, a self-management programme plus a verum thumb splint or a self-management programme plus a placebo thumb splint. The primary outcome is the Australian Canadian Osteoarthritis Hand Index (AUSCAN) hand pain scale. The study endpoint is 8 weeks after baseline. Baseline assessments will be carried out prior to randomisation and outcomes collected at 4, 8 and 12 weeks. Cost-effectiveness analysis will be conducted and individual qualitative interviews conducted with up to 40 participants after 8 weeks to explore perceptions and outcome expectations of verum and placebo splints and exercise.
South Central—Oxford C Research Ethics Committee approved this study (16/SC/0188). The findings will be disseminated to health professional conferences, journals and lay publications for patient organisations. The research will contribute to improving the management of thumb base OA and help clinicians and patients make informed decisions about the value of different interventions.
Depression is the leading cause of adult disability and common among sexual and gender minority (SGM) adults. The current study builds on findings showing the effectiveness of depression quality improvement (QI) and delivery of cognitive behavioural therapy (CBT) skills provided by community health workers in reducing depression. Depression QI approaches across healthcare and social/community services in safety-net settings have shown improvements in mental wellness, mental health quality of life and depression over 12 months. Further, a randomised study showed improved depression among low-income racial/ethnic minorities enrolled in a CBT-informed resiliency class (Building Resilience and Increasing Community Hope (B-RICH)). The current protocol describes a comparativeness effectiveness study to evaluate whether predominantly low-income, SGM racial/ethnic minority adults randomised to a CBT-informed resiliency class have improvements in depressive symptoms over and above community-engaged QI resources and training only.
The study approached three clusters of four to five programs serving predominantly SGM and racial/ethnic minority communities in the USA: two clusters in Los Angeles, California, and one in New Orleans, Louisiana. Clusters are comprised of one primary care, one mental health and two to three community agencies (eg, faith-based, social services/support, advocacy). All programs received depression QI training. The current study employed a community-partnered participatory research model to adapt the CBT-informed resiliency class, B-RICH+, to SGM communities. Study participants were screened and recruited in person from participating programs, and will complete baseline, 6- and 12-month survey follow-ups. Participants were depressed adults (8-item Patient Health Questionnaire ≥10; ≥18 years of age) who provided contact information. Enrolled participants were individually randomised to B-RICH+ or depression QI alone. Primary outcomes are depressive symptoms; secondary outcomes are mental health quality of life, mental wellness and physical health quality of life. Data collection for this study is ongoing.
The current study was approved by the UCLA Institutional Review Board. Study findings will be disseminated through scientific publications and community conferences.
Hypoxaemia during anaesthesia for tubeless upper airway surgery in children with abnormal airways is common due to the complexity of balancing adequate depth of anaesthesia with maintenance of spontaneous breathing and providing an uninterrupted field of view of the upper airway for the surgeon. High-flow nasal oxygenation (HIGH-FLOW) can prolong safe apnoea time and be used in children with abnormal airways but to date has not been compared with the alternative technique of low-flow nasal oxygenation (LOW-FLOW). The aim is to investigate if use of HIGH-FLOW can reduce the number of hypoxaemic events requiring rescue oxygenation compared with LOW-FLOW.
High-flow oxygen for children’s airway surgery: randomised controlled t rial (HAMSTER) is a multicentre, unmasked, randomised controlled, parallel group, superiority trial comparing two oxygenation techniques during anaesthesia. Children (n=530) aged >37 weeks to 16 years presenting for elective tubeless upper airway surgery who fulfil inclusion but not exclusion criteria will be randomised prior to surgery to HIGH-FLOW or LOW-FLOW post induction of anaesthesia. Maintenance of anaesthesia with HIGH-FLOW requires Total IntraVenous Anaesthesia (TIVA) and with LOW-FLOW, either inhalational or TIVA at discretion of anaesthetist. The primary outcome is the incidence of hypoxaemic events requiring interruption of procedure for rescue oxygenation by positive pressure ventilation and the secondary outcome includes total hypoxaemia time, adverse cardiorespiratory events and unexpected paediatric intensive care admission admission. Hypoxaemia is defined as Sp02
Ethical approval has been obtained by Children’s Health Queensland Human Research Ethics Committee (HREC/18/QRCH/130). The trial commenced recruitment in 2018. The primary manuscript will be submitted for publication in a peer-reviewed journal.
The HAMSTER is registered with the Australia and New Zealand Clinical TrialsRegistry: ACTRN12618000949280.
Kidney disease is common, affecting up to 1 in 10 of the adult population, and the numbers are expected to rise over the next decade. There are three main treatments that are available to patients with kidney disease: transplantation, dialysis and supportive care without dialysis. Dialysis can occur in a dialysis unit or in a person’s home, but unit-based dialysis remains the most common initial treatment for patients in Wales. This is a cause for concern as most studies suggest that it is associated with the lowest quality of life and the highest mortality, and is a more expensive treatment option.
This study aims to identify the factors that lead to patients choosing unit-based haemodialysis rather than home-based dialysis with a view to informing future changes in patient education and service commissioning in Wales. A secondary aim is to determine if the co-production of research leads to more sustainable services.
This mixed-method study taking place between October 2018 and September 2020 will use a sequential explanatory design whereby the descriptive quantitative cross-sectional analysis of linked health and administrative data sets inform qualitative data collection from patients, carers and health and care professionals. Qualitative findings will be used to interpret or explain quantitative descriptive results. Additional strands to the study include a review of materials and education provided to patients and an economic review of treatment modalities.
The study will be conducted in accordance with the principles expressed in the Declaration of Helsinki. It has full approval from Health and Care Research Wales Research Ethics Committee #5. As a co-productive study involving patients, clinicians, third sector partners and academics, findings from this study will be shared on a continual basis. Study results will be published in peer-reviewed journals and presented at national and international conferences.
Children with the single-gene disorder neurofibromatosis type 1 (NF1) appear to be at an increased risk for autism spectrum disorder (ASD) and exhibit a unique social-cognitive phenotype compared with children with idiopathic ASD. A complete framework is required to better understand autism in NF1, from neurobiological levels through to behavioural and functional outcomes. The primary aims of this study are to establish the frequency of ASD in children with NF1, examine the social cognitive phenotype, investigate the neuropsychological processes contributing to ASD symptoms and poor social functioning in children with NF1, and to investigate novel structural and functional neurobiological markers of ASD and social dysfunction in NF1. The secondary aim of this study is to compare the neuropsychological and neurobiological features of ASD in children with NF1 to a matched group of patients with idiopathic ASD.
This is an international, multisite, prospective, cross-sectional cohort study of children with NF1, idiopathic ASD and typically developing (TD) controls. Participants will be 200 children with NF1 (3–15 years of age), 70 TD participants (3–15 years) and 35 children with idiopathic ASD (7–15 years). Idiopathic ASD and NF1 cases will be matched on age, sex and intelligence. All participants will complete cognitive testing and parents will rate their child’s behaviour on standardised questionnaires. Neuroimaging will be completed by a subset of participants aged 7 years and older. Children with NF1 that screen at risk for ASD on the parent-rated Social Responsiveness Scale 2nd Edition will be invited back to complete the Autism Diagnostic Observation Scale 2nd Edition and Autism Diagnostic Interview-Revised to determine whether they fulfil ASD diagnostic criteria.
This study has hospital ethics approval and the results will be disseminated through peer-reviewed publications and international conferences.
Cumulative impact zones (CIZs) are a widely implemented local policy intended to restrict alcohol availability in areas proliferated with licensed outlets. Limited previous research has questioned their effectiveness and suggested they may play a more nuanced role in shaping local alcohol environments. This study evaluates the association between CIZ implementation and the number of licence applications made, and the number issued, relative to a control region.
A quantitative observational study.
The inner London Borough of Southwark, which currently enforces three CIZs.
Licence applications received by Southwark Council’s Licensing Authority between 1 April 2006 and 31 March 2017 (n=1254).
Five outlet types were categorised and evaluated: drinking establishments, eateries, takeaways, off sales and other outlets. Primary outcome measures were the number of applications received and the number of licences issued. These were analysed using Poisson regression of counts over time.
Across all CIZs, implementation was associated with greater increases in the number of eateries in CIZ regions (incidence rate ratio (IRR)=1.58, 95% CI: 1.02–2.45, p=0.04) and number of takeaway venues (IRR=3.89, 95% CI: 1.32–11.49, p=0.01), relative to the control area. No discernible association was found for the remaining outlet types. Disaggregating by area indicated a 10-fold relative increase in the number of new eateries in Peckham CIZ (IRR=10.38, 95% CI: 1.39–77.66, p=0.02) and a fourfold relative increase in the number of newly licensed takeaways in Bankside CIZ (IRR=4.38, 95% CI: 1.20–15.91, p=0.03).
CIZs may be useful as policy levers to shape local alcohol environments to support the licensing goals of specific geographical areas and diversify the night-time economy.
To conduct a health economic evaluation of a proposed investment in urban bicycle infrastructure in Stockholm County, Sweden.
A cost-effectiveness analysis is undertaken from a healthcare perspective. Investment costs over a 50-year life cycle are offset by averted healthcare costs and compared with estimated long-term impacts on morbidity, quantified in disability-adjusted life years (DALYs). The results are re-calculated under different assumptions to model the effects of uncertainty.
The Municipality of Stockholm (population 2.27 million) committed funds for bicycle path infrastructure with the aim of achieving a 15% increase in the number of bicycle commuters by 2030. This work is based on a previously constructed scenario, in which individual registry data on home and work address and a transport model allocation to different modes of transport identified 111 487 individuals with the physical capacity to bicycle to work within 30 min but that currently drive a car to work.
Morbidity impacts and healthcare costs attributed to increased physical activity, change in air pollution exposure and accident risk are quantified under the scenario. The largest reduction in healthcare costs is attributed to increased physical activity and the second largest to reduced air pollution exposure among the population of Greater Stockholm. The expected net benefit from the investment is 8.7% of the 2017 Stockholm County healthcare budget, and 3.7% after discounting. The economic evaluation estimates that the intervention is cost-effective and each DALY averted gives a surplus of 9933. The results remained robust under varied assumptions pertaining to reduced numbers of additional bicycle commuters.
Investing in urban infrastructure to increase bicycling as active transport is cost-effective from a healthcare sector perspective.
An urgent need to improve palliative care in hospital has been identified. Moreover, service users consistently report care delivered by nurses in hospital as lacking compassion. Compassion is a fundamental component of nursing care, and promoting compassionate care has been identified as a policy priority in many countries. To help address this within the hospital context, we recently completed research exploring bereaved family experiences of good end of life care in hospital. We found that family accounts of good care aligned with Nolan and Dewar's compassionate care framework and subsequently extended the framework to the bi‐cultural context of Aotearoa, New Zealand.
In this discussion paper, we explore synergies between our newly developed Kapakapa Manawa Framework: a bi‐cultural approach to providing compassionate care at the end of life and the Fundamentals of Care. We argue that our framework can be used to support the implementation of the relational component of the Fundamentals of Care and the delivery of compassionate nursing practice in hospitals in Aotearoa, New Zealand.
Review of relevant literature and construction of two vignettes describing good end of life care from the perspectives of bereaved family—one Māori and one non‐Māori. The vignettes provide practical examples of how the values of the Kapakapa Manawa Framework can be enacted by nurses to provide compassionate care in alignment with the relationship component of the Fundamentals of Care.
Whilst the Kapakapa Manawa bi‐cultural compassionate care framework has grown out of research conducted with people nearing the end of their lives, it has the potential to improve nursing care for all hospital inpatients.
Addressing the wider policy and health system factors detailed in the Fundamentals of Care will support its implementation in the clinical setting.