NIHRDataInsights/HRCSData huggingface dataset:
Title: A controlled study of the effectiveness of breathing training exercises taught by a physiotherapist by either instructional videos/DVDs/internet download or by face-to-face sessions in the management of asthma in adults
Funder: Department of Health (England)

Abstract: BackgroundAsthma affects 5 million people in the UK and costs the NHS in excess of £1 billion. Although pharmacotherapy is effective and can provide control for many patients surveys repeatedly show that outcomes remain sub-optimal. Over half of all adults with asthma in the UK are not properly controlled on their current treatment regimen. In addition to resulting in impaired quality of life poor asthma control results in increased costs to the community both in terms of direct medical cost and in indirect costs through loss of productivity.Recent studies have shown clinically important effectiveness for people with asthma in the UK from physiotherapist administered breathing exercises. There are suggestions that similar beneficial effects may be achieved through the use of videotaped instructional interventions rather than face-to face instruction. MethodsThree phases of research are planned:Phase 1: Development phase - transfer of programme to audio-visual media: Qualitative pilotingPhase 2 Randomised controlled clinical trial (RCT)A pragmatic observer blinded 3 arm parallel group randomised controlled trial comparing a breathing training programme delivered through a video/ DVD/ download with a face to face physiotherapist programme and a control arm receiving usual care for adults with asthma and impaired health status.585 patients (234 in each of the video/DVD/download and ‘usual care’ arms and 117 in the ‘face to face’ physiotherapy arm) recruited from 20 general practice centres.Baseline questionnaires and physiological measurements with 3 and 6 month questionnaire follow up with final questionnaires and physiological assessments at 12 months.Phase 3: Health Economic EvaluationIf this research can show similar benefits can be achieved through the use of videotaped instructional interventions without face-to-face contact with a healthcare professional it is likely that the health resource implications of providing breathing training would be reduced and that this technology could be realistically made available to the many people with asthma who could potentially benefit from it.


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: RESPIRATORY
Title: Bronchiolitis of Infancy Discharge Study (BIDS): a multi-centre parallel-group double blind randomised controlled equivalence study with economic evaluation
Funder: Chief Scientist Office (Scotland)

Abstract: Setting: The study will take place in the emergency departments/acute assessment areas (ED/AAA) and paediatric wards of four University Teaching Hospitals in Scotland (Aberdeen Dundee Edinburgh Glasgow) University Hospital Crosshouse (Kilmarnock) and in three hospitals in the south west of England (Bristol Exeter Truro). Target Population: Participants will be infants older than 6 weeks and less than or equal to 12 months of age presenting to a participating hospital ED/AAA with a clinical diagnosis of bronchiolitis made by acute receiving medical staff and who require admission to hospital for supportive care. Exclusion criteria are (a) Preterm (<37 weeks) who have received home oxygen therapy in the past 4 weeks (2) Haemodynamically significant congenital heart disease (3) Cystic Fibrosis or known Interstitial Lung Disease (4) Documented immune function defect. Health Technologies Being Assessed: Arterial pulse oxygen saturation (SpO2) limits by the use of pulse oximeters. To test whether acceptance of lower SpO2 limits influences recovery from acute bronchiolitis randomisation will be to standard or modified pulse oximeters identical in external appearance and function. Standard oximeters will measure and display SpO2 as usual. Infants otherwise receive usual care following admission to hospital and will be eligible for discharge once oral feeding is re-established and SpO2 is displayed as greater than or equal to 94% in air for a minimum of four hours including a period of sleep. All clinicians caring for infants parents and the study staff involved in day-to-day trial management and outcome assessment will be blinded to study allocation.Measurement of outcomes: As detailed above.Measurement of costs: We will estimate the incremental cost and effectiveness of the 90% compared to 94% SpO2 discharge procedure in terms of health social care and societal costs as well as the clinical and QOL outcome measures. The economic analysis will also take into consideration the ‘seasonality’ of the disease and the economic impact of this with regard to availability of ward space/beds during peak hospital times.


Research activity codes: 6.7 PHYSICAL
Health categories: RESPIRATORY
Title: SABRE: HYPERTONIC SALINE IN ACUTE BRONCHIOLITIS: RANDOMISED CONTROLLED TRIAL ECONOMIC EVALUATION SYSTEMATIC REVIEW AND META-ANALYSIS
Funder: Department of Health (England)

Abstract: This is a multicentre randomised controlled trial which aims to determine whether the addition of 3% hypertonic saline to usual care results in significant [25%] reduction in the duration of hospitalisation of infants with acute bronchiolitis. Infants will be randomised to receive nebulised 3% hypertonic saline in addition to supportive care (n=150) or standard supportive care (n=150). The primary outcome will be time to ‘fit for discharge’. Secondary outcomes will include the economic impact of such an intervention on both the National Health Service (NHS) and parents as well as quality of life and other health related outcomes 28 days after entry to the study using a questionnaire symptom diary and research nurse telephone contact.


Research activity codes: 6.1 PHARMACEUTICALS
Health categories: RESPIRATORY
Title: A Study of Donor Ex-vivo Lung Perfusion in UK Lung Transplantation (DEVELOP-UK)
Funder: Department of Health (England)

Abstract: DEVELOP-UK is a non-randomised non-inferiority observational study with an adaptive design to evaluate the clinical and cost effectiveness of lung transplantation performed using EVLP assessed and reconditioned donor lungs compared with lung transplantation using standard donor lungs. This multi-centre study involving all 5 officially designated NHS adult lung transplant centres is open to all adult patients aged 18 years and over with advanced lung disease already on an active lung transplant waiting list in one of the 5 centres and any new adult patients as they are added to the waiting list.EVLP is a novel technique in which unusable donor lungs which are functioning poorly or in which function is uncertain can be further assessed and potentially reconditioned for safe use in clinical lung transplantation. EVLP is performed outside the donor or recipient body by connecting the lungs to a “modified” heart-lung bypass machine and pumps a specialised perfusate through them while they are simultaneously ventilated. EVLP provides the opportunity to carefully assess donor lung function including gas exchange ability over a number of hours before making a decision on their usability for transplantation. The study is designed to demonstrate non-inferiority of EVLP in terms of 12 month survival. If the study runs to full recruitment then at least 306 patients would be required in the standard arm and 102 in the EVLP arm to give more than 80% power. This makes allowance for a group sequential design that has been used to inflate the sample sizes for the 2 planned interim analyses. The 90 day and 12 month mean cost of undertaking lung transplant using EVLP lungs and standard donor lungs will be assessed. QOL will be determined using the SF-36 in all recipients at 90 day and 12 month post-transplant time points. In addition qualitative focused interviews with patients waiting and the same number following lung transplant will explore attitudes towards choice and experiences of receiving EVLP treated donor lungs.


Research activity codes: 6.4 SURGERY
Health categories: RESPIRATORY
Title: Preventing and Lessening Exacerbations of Asthma in School-age children Associated with a New Term (PLEASANT)
Funder: Department of Health (England)

Abstract: Design: The study will be a cluster randomised trial; 70 GP practices in the intervention group and 70 control practices of “usual care”. The randomisation will be stratified by size of GP practice and will not be disclosed prior to enrolment of a GP practice. The intervention practices will be asked toprepare and send out an intervention to all their school aged children with asthma based on inclusion/exclusion criteria. We will extract all medical contact and outcome data through the Clinical Practice Research Datalink (CPRD) with no need to contact the GP practices for this information sokeeping the burden to practices at a minimum. Thus the control practices will have not further contact with the study team following consent.Setting: The setting will be in primary care with general practices currently part of Clinical Practice Research Datalink (CPRD).Target Population: School age asthmatic children (aged 5-16).Health Technologies Being Assessed: An NHS delivered public health intervention sent to the parents of children with asthma.Measurment of Cost and Outcome: The primary outcome is the proportion of patients who have an unscheduled medical contact in September. Secondary outcomes will include: the proportion of patients who have an unscheduled medical contact in September to December; the number of unscheduled medical contacts per patient in September (and September to December); the proportionof patients who have an unscheduled medical contact in September (and September to December) associated with a respiratory diagnosis; the number of unscheduled medical contacts per patient in September (and September to December) associated with a respiratory diagnosis; the number of prescriptions per patient in the month of August and the number of prescriptions per patient in the 12 months from August.Cost Effectiveness Analysis: An economic evaluation will be undertaken to compare the incremental cost per quality adjusted life year (QALY) of the intervention ersus standard care. The perspective of the analysis will be that of the NHS and Personal Social Services. Data on the number and type ofmedical contacts avoided in the intervention group will be collected through the CPRD and will be combined with PSSRU unit costs to assess any cost savings associated with preventing exacerbations. This will be compared to the additional cost of the intervention.


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: RESPIRATORY
Title: The cost-effectiveness of domicilary non-invasive ventilation (NIV) in patients with end-stage COPD. A systematic review and economic evaluation
Funder: Department of Health (England)

Abstract: Chronic obstructive pulmonary disease (COPD) is a chronic progressive lung disease characterised by non-reversible airflow obstruction leading to progressively worsening breathlessness. It mostly affects middle aged or elderly people who have smoked and it is increasingly recognised as an important long-term respiratory condition with a high burden on patients carers and NHS resources. Currently treatment aims to reduce symptoms and to slow disease progression. COPD is the fifth most common disease presenting to emergency departments in the UK. Around 44% of those admitted to hospital acutely have hypercapnic respiratory failure with elevated pCO2 (>6.0kPa). There is good evidence that hypercapnic respiratory failure during an acute exacerbation should be treated with non-invasive ventilation (NIV); a method of providing ventilatory support via a mask. Even so the median time to death after a single episode of acute hypercapnic respiratory failure requiring NIV is 16 months with readmission rates of up to 80% within 12 months. The benefit of NIV in a hospital setting combined with the poor prognosis of those subsequently discharged has led to randomised-controlled trials of NIV at home aimed at reducing mortality and readmission rates. However there is variation between study methods physiological/clinical outcomes measured and adjustment for clinical variables (e.g. oxygen or prior acute NIV use) which has limited the overall conclusions drawn from the totality of these trials. There are at least two ongoing randomised-controlled trials. Furthermore a number of observational studies have been undertaken. Very few cost-effectiveness studies have been done.We will undertake systematic reviews of this evidence and incorporate the findings in a de-novo model-based cost-utility analysis to determine the cost-effectiveness of NIV in a home/community setting from UK NHS/Personal Social Services/wider societal perspective for all severe/end stage hypercapnic COPD patients and for any identifiable sub-groups.


Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES;6.7 PHYSICAL
Health categories: RESPIRATORY
Title: A study of quality of care needs for patients with idiopathic pulmonary fibrosis, and their carers, across disease trajectory
Funder: Marie Curie

Abstract: Idiopathic pulmonary fibrosis (IPF) is a progressive life-limiting condition characterised by chronic inflammation and progressive lung fibrosis. This results in worsening breathlessness, functional decline and eventual death, with a highly variable clinical course. There are approximately 4000 new cases of IPF diagnosed each year in the UK, an incidence which exceeds that of cervical cancer and of the acute leukaemias combined. Average survival is less than three years. Despite awareness that patients with IPF have specific palliative care needs, there is very little primary research to guide delivery. Differing disease trajectories also present specific barriers to intervention and challenges for coordination of care. There remains considerable uncertainty regarding the timing of palliative care interventions, the service configuration needed to support patients and carers and their information needs in negotiating optimal management. These key elements must be addressed in order to define clinically effective patterns of care. Relevance to the call: (Helping people address and manage the uncertainty which is often faced by those suffering advanced and progressive illnesses (including cancer). This study will address uncertainties in relation to the palliative care needs of patients with IPF, and their carers. Capturing experience across the disease trajectory will provide key information for the development and evaluation of future service models. In particular, it will inform the definition of interventions and of meaningful outcomes. Specific aims are to: • identify changes in patients’ and carers’ perceived palliative care needs over the progression of the disease in order to improve future service interventions • identify time-points or triggers at which palliative care services might effectively be introduced • define the specific information needs of patients and carers • evaluate specifically the experiences and roles of the carer Outline Research Plan 1. Qualitative interviews with patients and carers will be undertaken at time-points chosen to reflect patient and carer experience across different disease trajectories. Data will be analysed using Interpretative Phenomenological Analysis (IPA). This approach involves trying to understand the experiences of individuals, and how they make sense of them. 2. Objective data will also be captured on demographic variables, symptom severity and service use and correlated with perceived care needs. A complementary analysis of the quantitative and qualitative data will help define time points or symptom/physiological triggers for palliative care involvement. Definition of interventions and outcomes meaningful to patients and carers will be identified to inform design and evaluation of service provision.


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;7.2 END OF LIFE CARE
Health categories: RESPIRATORY
Title: End of life care in advanced Chronic Obstructive Pulmonary Disease (COPD): identifying, understanding and meeting the changing care and support needs of patients and their carers
Funder: Marie Curie

Abstract: Background Chronic obstructive pulmonary disease (COPD) is a chronic progessive condition with high symptom- and carer-burden, accounting for one death every 20 minutes in England and Wales. National strategy documents state that quality end-of-life care should be available to patients with any condition, yet we rely on planning tools developed for cancer with its differing trajectory. We need a new framework based on recognition of the slow relentless progression of non-malignant disease and its effect on patients and carers. To inform this we will provide new evidence on the trajectory of health and social care needs and preferences (and whether these change) of these patients, and their carers, in differing contexts. Aims To explore variation in the experience and outcome of care in advanced COPD in relation to: 1) changing physical, psychological and social needs of patients and carers at the end-of-life from patients’, carers’ and clinicians’ perspectives; 2) care preferences (places and sources of care) at the end-of-life; 3) barriers and facilitators to clinicians’ ability to meet needs at the end-of-life; and, 4) service-provider stakeholder (clinicians, managers and commissioners) strategies for meeting needs and preferences at the end-of-life. Methods These aims will be delivered through four linked component studies: 1) a mixed-method 18-month Longitudinal Study of advanced COPD patients (n=60) and their carers: 3-monthly semi-structured interviews with flexible methodology to capture changing function, need and service-access. 2) Care Preferences Survey: Discrete Choice Experiments (using preference vignettes) within a longitudinal postal survey (n=250) to identify change in care preferences in relation to changing need, conducted in 2-centres for geographical, social and ethnic contrast. 3) Barriers and Facilitators Study: brief longitudinal interviews with clinicians (identified by Longitudinal Study patients), to identify barriers/facilitators to meeting need. 4) Service-provider Stakeholder Study: focus groups with clinicians, managers and commissioners to consider implications of findings for clinical practice, management and policy. How the results of this research will be used The results will support the needs of commissioners and service-providers by highlighting variation in the experience and outcome of care at the end-of-life in COPD. Working with stakeholders it will identify innovative ways clinical teams and health systems might respond. The study has generic resonance beyond COPD with outcomes relevant to the substantial number of patients and carers living with other advanced progessive chronic conditions. It will inform a new framework for end-oflife care in non-malignant conditions.


Research activity codes: 7.2 END OF LIFE CARE;7.3 MANAGEMENT AND DECISION MAKING
Health categories: RESPIRATORY
Title: The adaptation and validation of an assessment tool to identify the palliative care needs of people with irreversible idiopathic interstitial lung disease for use in every day clinical practice
Funder: Marie Curie

Abstract: Purpose To adapt and validate a needs assessment tool that is fit for purpose in every day clinical practice, able to facilitate the identification of palliative needs of people with interstitial lung disease (ILD), and to triage those requiring referral to specialist palliative care (SPC) services. Background ILD is a group of conditions resulting in lung fibrosis. Many patients experience a progressive loss of functional ability and, ultimately, die from acute respiratory failure. Severe and distressing breathlessness, cough, fatigue and pain are experienced by most in the last year of life in conjunction with psycho-social, financial and spiritual distress. Despite this, patients and carers often have poor understanding of their illness and what to expect as the disease advances. In addition there is poor communication and coordination of care, with vast unmet information needs. National guidelines relating to the most common type of lung fibrosis, (interstitial pulmonary fibrosis) recognise that patients have specific palliative care needs. Despite this, routine assessments of such needs are not part of everyday clinical practice, and palliative care services are rarely accessed by this group of people. The needs assessment tool-progressive disease (NAT:PD-C), developed for use in the oncology setting, is an ”aide-memoire” designed to help a busy clinician identify patients with palliative needs in daily practice. Use of the NAT:PD-C has been shown to reduce unmet palliative care needs and has been adapted for heart failure patients. A clinician-rated tool, for use in the clinic or ward round and which can identify patients likely to have palliative care needs, is currently missing in ILD management. Aim We aim to adapt and validate the NAT:PD-C for use in ILD. Methods We are a three site collaborative (Hull, London, Manchester). All members of the research group will contribute to the project as a whole, with each centre leading one stage to allow a time and cost-efficient approach. This will be a four stage project: 1. Adapt the NAT:PD-C using the information from our published systematic literature review and qualitative interviews with patients, carers and health care staff. 2. Test the adapted NAT (NAT:PD-ILD) for face validity. 3. Test the NAT:PD-ILD for inter-rater and test-retest reliability using videorecorded patient consultations. 4. Test the construct validity of the NAT:PD-ILD against agreed comparator constructs using health related quality of life instruments in use for people with interstitial pulmonary fibrosis.


Research activity codes: 7.2 END OF LIFE CARE;7.3 MANAGEMENT AND DECISION MAKING
Health categories: RESPIRATORY