Cookies on this website
We use cookies to ensure that we give you the best experience on our website. If you click 'Continue' we'll assume that you are happy to receive all cookies and you won't see this message again. Click 'Find out more' for information on how to change your cookie settings.
  • Understanding the impact of delegated home visiting services accessed via general practice by community-dwelling patients: A realist review protocol

    17 December 2018

    © 2018 Author(s). Introduction In western countries, early visiting services (EVS) have been proposed as a recent intervention to reduce both general practitioner workload and hospital admissions among housebound individuals experiencing a healthcare need within the community. EVS involves the delegation of the patient home visits to other staff groups such as paramedics or nursing staff. However, the principles of organising this care are unknown and it remains unclear how different contexts, such as patient conditions and the processes of organising EVS influence care outcomes. A review has been designed to understand how EVS are enacted and, specifically, who benefits, why, how and when in order to provide further insight into the design and delivery of EVS. Methods and analysis The purpose of this review is to produce findings that provide explanations of how and why EVS contexts influence their associated outcomes. Evidence on EVS will be consolidated through realist review- A theory-driven approach to evidence synthesis. A realist approach is needed as EVS is a complex intervention. What EVS achieve is likely to vary for different individuals and contexts. We expect to synthesise a range of relevant data such as qualitative, quantitative and mixed-method research in the following stages: Devising an initial programme theory, searching evidence, selecting appropriate documents, extracting data, synthesising and refining the programme theory. Ethics and dissemination A formal ethics review is not required as this study is secondary research. Findings will be disseminated in a peer-reviewed journal, at national and international conferences and to relevant professional associations.

  • Oral steroids for hearing loss associated with otitis media with effusion in children aged 2–8 years: The OSTRICH RCT

    14 December 2018

    © Queen’s Printer and Controller of HMSO 2018. Background: Children with hearing loss associated with otitis media with effusion (OME) are commonly managed through surgical intervention, hearing aids or watchful waiting. A safe, inexpensive, effective medical treatment would enhance treatment options. Small, poorly conducted trials have found a short-term benefit from oral steroids. Objective: To determine the clinical effectiveness and cost-effectiveness of a 7-day course of oral steroids in improving hearing at 5 weeks in children with persistent OME symptoms and current bilateral OME and hearing loss demonstrated by audiometry. Design: Double-blind, individually randomised, placebo-controlled trial. Setting: Ear, nose and throat outpatient or paediatric audiology and audiovestibular medicine clinics in Wales and England. Participants: Children aged 2–8 years, with symptoms of hearing loss attributable to OME for at least 3 months, a diagnosis of bilateral OME made on the day of recruitment and audiometry-confirmed hearing loss. Interventions: A 7-day course of oral soluble prednisolone, as a single daily dose of 20 mg for children aged 2–5 years or 30 mg for 6-to 8-year-olds, or matched placebo. Main outcome measures: Acceptable hearing at 5 weeks from randomisation. Secondary outcomes comprised acceptable hearing at 6 and 12 months, tympanometry, otoscopic findings, health-care consultations related to OME and other resource use, proportion of children who had ventilation tube (grommet) surgery at 6 and 12 months, adverse effects, symptoms, functional health status, health-related quality of life, short-and longer-term cost-effectiveness. Results: A total of 389 children were randomised. Satisfactory hearing at 5 weeks was achieved by 39.9% and 32.8% in the oral steroid and placebo groups, respectively (absolute difference of 7.1%, 95% confidence interval –2.8% to 16.8%; number needed to treat = 14). This difference was not statistically significant. The secondary outcomes were consistent with the picture of a small or no benefit, and we found no subgroups that achieved a meaningful benefit from oral steroids. The economic analysis showed that treatment with oral steroids was more expensive and accrued fewer quality-adjusted life-years than treatment as usual. However, the differences were small and not statistically significant, and the sensitivity analyses demonstrated large variation in the results. Conclusions: OME in children with documented hearing loss and attributable symptoms for at least 3 months has a high rate of spontaneous resolution. Discussions about watchful waiting and other interventions will be enhanced by this evidence. The findings of this study suggest that any benefit from a short course of oral steroids for OME is likely to be small and of questionable clinical significance, and that the treatment is unlikely to be cost-effective and, therefore, their use cannot be recommended. Future work: Studies exploring optimal approaches to sharing natural history data and enhancing shared decision-making are needed for this condition. Trial registration: Current Controlled Trials ISRCTN49798431 and EudraCT 2012-005123-32.

  • A manual-based intervention for carers of people with dementia and sleep disturbances: an acceptability and feasibility RCT.

    19 December 2018

    BACKGROUND: It has been estimated that between 25% and 40% of people living with dementia suffer from sleep disturbances, and there are currently no known effective treatments. Sleep disturbances may be the direct result of dementia or due to other comorbidities, such as pain and limited mobility. If carers' sleep is also disturbed, carers too can become tired and stressed, and this sometimes results in the breakdown of care in the home. OBJECTIVES: To design an evidence-based manualised non-pharmacological therapy for sleep disturbances and test it for feasibility and acceptability. DESIGN: A single-blind, randomised, parallel-group feasibility trial, with participants randomised 2 : 1 to intervention or treatment as usual (TAU). SETTING: Five memory services in two London NHS trusts and Join Dementia Research (JDR). PARTICIPANTS: The study recruited people with dementia and sleep disturbances (who scored ≥ 4 on at least one question on the Sleep Disorders Inventory) and their primary family carers. INTERVENTION: All participants were given an Actiwatch (CamNtech Ltd, Cambridge, UK) to wear to record their sleep patterns for 2 weeks before randomisation. The intervention group received Dementia RElAted Manual for Sleep; STrAtegies for RelaTives (DREAMS START). This was designed as a six-session, manual-based intervention for carers of people with dementia, delivered by trained and clinically supervised psychology graduates, based on evidence about managing sleep disturbance in people with dementia. It uses the structure of a previous manual-based treatment, STrAtegies for RelaTives (START). Family carers were consulted about structure, content and design. Sessions were interactive, and each involved techniques, tasks to practise between sessions, relaxation and a recapitulation on the previous session. The sessions covered understanding sleep and dementia, making a plan (incorporating information from Actiwatch read-outs and a light box to increase light), daytime activity and routine, difficult night-time behaviours, taking care of your own (carer's) sleep and using the strategies in the future. Carers kept their own manual, light box and relaxation recordings post intervention. RANDOMISATION AND BLINDING: A statistician created an electronic randomisation list, stratified by site, using random permuted blocks. Those assessing the outcome were blinded to allocation; participants were not blinded. MAIN OUTCOME MEASURES: Outcomes were assessed at 3 months. (1) Feasibility, defined as the percentage of eligible people who consented to the study recruitment, with an expected value of 50% [95% confidence interval (CI) 41% to 59%]. (2) Acceptability, defined as the percentage of intervention group participants attending ≥ 4 intervention sessions, with an expected value of 75% (95% CI 59% to 87%). The predetermined criterion for progression to the main trial was acceptability of ≥ 70%. RESULTS: Of 95 eligible patients referred, 63 (66%, 95% CI 56% to 76%) consented between 4 August 2016 and 24 March 2017: 61 from memory clinics and two from JDR. Of these, 62 participants (65%, 95% CI 55% to 75%) were randomised: 42 to the intervention arm and 20 to the TAU arm. Thirty-seven out of 42 participants (88%, 95% CI 75% to 96%) adhered to the intervention. CONCLUSIONS: The results show that the randomised controlled trial is feasible and that the intervention is acceptable. A higher than expected proportion of eligible patients referred consented to the study and adhered to the intervention. LIMITATIONS: Participants were not blinded and were recruited only in London. FUTURE WORK: The results of this trial indicate that a future efficacy trial is warranted. TRIAL REGISTRATION: Current Controlled Trials ISCTRN36983298. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 71. See the NIHR Journals Library website for further project information. Funding was also provided by Camden and Islington NHS Foundation Trust and Barnet, Enfield and Haringey Mental Health NHS Trust to pay for excess treatment costs from therapist training and supervision and intervention delivery.

  • Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial

    20 November 2018

    © 2018 American Medical Association. All rights reserved. Importance: Digital cognitive behavioral therapy (dCBT) is a scalable and effective intervention for treating insomnia. Most people with insomnia, however, seek help because of the daytime consequences of poor sleep, which adversely affects quality of life. Objectives: To investigate the effect of dCBT for insomnia on functional health, psychological well-being, and sleep-related quality of life and to determine whether a reduction in insomnia symptoms was a mediating factor. Design, Setting, and Participants: This online, 2-arm, parallel-group randomized trial comparing dCBT for insomnia with sleep hygiene education (SHE) evaluated 1711 participants with self-reported symptoms of insomnia. Participants were recruited between December 1, 2015, and December 1, 2016, and dCBT was delivered using web and/or mobile channels plus treatment as usual; SHE comprised a website and a downloadable booklet plus treatment as usual. Online assessments took place at 0 (baseline), 4 (midtreatment), 8 (posttreatment), and 24 (follow-up) weeks. Programs were completed within 12 weeks after inclusion. Main Outcomes and Measures: Primary outcomes were scores on self-reported measures of functional health (Patient-Reported Outcomes Measurement Information System: Global Health Scale; range, 10-50; higher scores indicate better health); psychological well-being (Warwick-Edinburgh Mental Well-being Scale; range, 14-70; higher scores indicate greater well-being); and sleep-related quality of life (Glasgow Sleep Impact Index; range, 1-100; higher scores indicate greater impairment). Secondary outcomes comprised mood, fatigue, sleepiness, cognitive failures, work productivity, and relationship satisfaction. Insomnia was assessed with the Sleep Condition Indicator (range: 0-32; higher scores indicate better sleep). Results: Of the 1711 participants included in the intention-to-treat analysis, 1329 (77.7%) were female, mean (SD) age was 48.0 (13.8) years, and 1558 (91.1%) were white. Use of dCBT was associated with a small improvement in functional health compared with SHE (adjusted difference [95% CI] at week 4, 0.90 [0.40-1.40]; week 8, 1.76 [1.24-2.28]; week 24, 1.76 [1.22-2.30]) and psychological well-being (adjusted difference [95% CI] at week 4, 1.04 [0.28-1.80]; week 8, 2.68 [1.89-3.47]; week 24, 2.95 [2.13-3.76]), and with a large improvement in sleep-related quality of life (at week 4, -8.76 [-11.83 to -5.69]; week 8, -17.60 [-20.81 to -14.39]; week 24, -18.72 [-22.04 to -15.41]) (all P <.01). A large improvement in insomnia mediated these outcomes (range mediated, 45.5%-84.0%). Conclusions and Relevance: Use of dCBT is effective in improving functional health, psychological well-being, and sleep-related quality of life in people reporting insomnia symptoms. A reduction in insomnia symptoms mediates these improvements. These results confirm that dCBT improves both daytime and nighttime aspects of insomnia, strengthening existing recommendations of CBT as the treatment of choice for insomnia. Trial Registration: identifier: ISRCTN60530898.

  • EBM DataLab

    25 April 2017

  • CPRD Research Group

    28 November 2018

    Our main aim is to assist researchers to conduct high quality primary care research using data from the Clinical Practice Research Datalink (CPRD).

  • Cancer Research

    26 June 2012

  • Stratified TreAtments Research (STAR)

    9 November 2018

    We use information from large databases of electronic health records to better target preventative treatments at those patients with the most to gain

  • Heart Failure

    26 June 2012

    Our research focuses on heart failure in primary care. We explore the burden of heart failure in primary care populations and the impact on patients. We have a particular interest in heart failure diagnosis and screening in primary care settings.

  • Stroke Prevention and Atrial Fibrillation

    26 June 2012

    Reducing the risk of stroke is vital to improving the health of older people. We research ‘funny turns’ that are a warning sign of stroke (termed ‘transient ischaemic attacks’) and the detection and treatment of major risk factors for stroke - high blood pressure and atrial fibrillation.

  • Primary Care for the Developing World

    26 June 2012

    Our aim is to support the provision of high quality primary health care in countries with limited economic resources, undertaking research and policy development in collaboration with academic institutions, NGOs and government agencies.

  • Monitoring and Diagnosis (MaDOx)

    26 June 2012

    Our aim is to improve monitoring and diagnostics used in primary care and community settings.

  • Infectious Diseases Research Group

    26 June 2012

    We investigate infectious diseases in primary care to find out how we can identify patients with serious infection in primary care, and more effective ways of diagnosing and treating patients with common infections.