NIHR open research最新文献

Introduction: The last decades have witnessed a series of initiatives in the United Kingdom (UK) to enhance patient access to quality care including access to medicine without compromising patient's safety. Pharmacist independent prescribing is one of the initiatives introduced in 2006 with the intention of making more effective use of the skills and competencies of health professionals. Community pharmacy has a key role in the NHS long-term plan since pharmacies offer convenient and accessible sources of healthcare advice for the public. This role is more evident with the introduction of prescribing for all qualified pharmacists at the point of registration starting 2026. This realist review aims to explore how does independent prescribing in community pharmacy works, for whom, in what circumstances and how.

Method and analysis: Realist research seeks to explore and explain complex social interventions by utilising programme theories providing causal explanations of outcomes in terms of context-mechanism-outcome configurations.INTEGRATE will progress through six stages. In the first stage, we will partner with Patient, Public, Involvement and Engagement Group (PPIE) and Practitioner Stakeholder Group (SG), to further scrutinise the review's focus. In stage 2, we will develop initial programme theories for what makes independent prescribing effective in community pharmacy, for whom, in what circumstances and how. In the third stage, we will conduct literature searches to gather secondary data that will help refine our initial programme theories.In stage 4, we will select and appraise identified articles by screening titles, abstracts and full texts against inclusion and exclusion criteria. In stage 5, we will extract, document and code relevant data, followed by realist analysis with contributions from the PPIE and SG. Stage 6 focuses on refining programme theories and identifying key mechanisms that lead to desired outcomes.PROSPERO registration: CRD42023468451.

Liver disease is a major, and increasing, cause of death in the UK. The UK Chronic Liver Failure network (UK-CLIF) was developed as a multi-stakeholder network with the aim to advance cirrhosis research, with emphasis on geographical areas of high disease prevalence or limited research activity. The process involved network development through dissemination and snowball sampling techniques, with monitoring of network development and connections between participants, developed over two online meetings. Network membership included representatives from patients, carers, clinicians, researchers, R&D professionals, industry representatives, and the third sector. Subsequently, two facilitated in-person workshops were conducted with network participants. World Café methodology and participant dot voting was used to develop areas of priority and consensus in: (i) research infrastructure for cirrhosis clinical trials, (ii) clinical factors affecting research delivery, and (iii) research priorities for future trials. Thematic analysis demonstrated that the need for patient-centric trial materials, a lack of resource for clinicians to participate in research, and variability in the standard of inpatient care for cirrhosis, were barriers for cirrhosis clinical trials. Future activities for UK-CLIF include participation in a process of quality standard setting for inpatient care for cirrhosis, and coordination of a James Lind Alliance Priority Setting Partnership to develop research questions for liver cirrhosis.

Background: Opioid substitution therapy (also known as 'opioid agonist therapy' or 'medication treatment of opioid use disorder') is associated with improved health and social outcomes for people who use heroin and other illicit opioids. It is typically managed in the community and is not always continued when people are admitted to hospital. This causes opioid withdrawal, patient-directed discharge, and increased costs. We are establishing a project called iHOST (improving hospital opioid substitution therapy) to address these problems. This is an applied health research project in which we will develop and evaluate an intervention that aims to improve opioid substitution therapy in three acute hospitals in England. The intervention was developed in collaboration with stakeholders including people who use opioids, hospital staff, and other professionals who work with this group. It includes five components: (1) a card that patients can use to help hospital clinicians confirm their opioid substitution therapy, (2) a helpline for patients and staff, (3) an online training module for staff, (4) a clinical guideline for managing opioid withdrawal in hospital, and (5) 'champion' roles at each hospital.

Methods: We will do a mixed-methods study including a quasi-experimental quantitative study and a qualitative process evaluation. The primary outcomes for the quantitative study are patient-directed discharge and emergency readmission within 28 days. We will do a difference-in-difference analysis comparing changes in these outcomes for patients at iHOST sites with changes for patients at control hospitals. The process evaluation will use in-depth interviews, focus groups, and site observations with people who use opioids and staff. We will assess acceptability of the intervention, barriers and facilitators to implementation, and contextual factors impacting outcomes.

Impact: We anticipate that iHOST will improve care for hospital patients who use illicit opioids and/or are receiving community-based opioid substitution therapy. Depending on the results, we will promote the intervention at hospitals across the UK. Dissemination, including through publication, will inform hospital-based services for people who use drugs both in the UK and other countries.

Background: Major congenital anomalies (CAs) affect around 2% of live births and are a primary cause of infant mortality, childhood morbidity and long-term disability, often requiring hospitalisation and/or surgery. Children with CAs are at greater risk of lower educational attainment compared with their peers, which could be due to learning disabilities, higher rates of ill-health and school absences, or lack of adequate educational support. Our study will compare the educational attainment of children with CAs to those of their peers up to age 11 in England, using linked administrative health and education data.

Methods: We will analyse data from the ECHILD (Education and Child Health Insights from Linked Data) database. Children born in NHS-funded hospitals from 1st September 2003 to 31st August 2008 whose hospital records were linked to their educational records at three Key Stages (ages 4/5, 6/7 and 10/11 years) will be included. Children with different CAs, indicated by recorded hospital diagnosis codes, will be compared to children without CAs. We will compare the proportions of enrolled children who take the assessment, the proportions who reached national expected levels of attainment, and the mean standardised attainment scores for Maths and English at each Key Stage. We will describe variations in outcome by sex, ethnic minority background, region, and neighbourhood deprivation, and perform regression modelling to compare the attainment trajectories of children with and without CAs, controlling for sociodemographic factors.

Ethics and dissemination: Ethics approval has been obtained for the analyses of the ECHILD database. Our findings will provide information for parents regarding their children's expected academic potential, and also enable the development of interventions to support those at risk of not doing well. We will disseminate our findings to academics, policy makers, service users and providers through seminars, peer-reviewed publications, conference abstracts and other media (lay summaries and infographics).

Introduction: During the COVID-19 pandemic, extensive research was conducted on SARS-CoV-2; however, important questions about other respiratory pathogens remain unanswered. A severe influenza season in 2022-2023 with simultaneous circulation of SARS-CoV2 and respiratory syncytial virus is anticipated. This sub-study aims to determine the incidence and impact of these respiratory viruses on healthcare workers, the symptoms they experienced, the effectiveness of both COVID-19 and influenza vaccination and the burden of these infections on the National Health Service (NHS) workforce.

Methods and analysis: This is a longitudinal prospective cohort sub-study, utilising the population and infrastructure of the SARS-CoV-2 Immunity & Reinfection Evaluation (SIREN) study, which focuses on hospital staff in the UK. Participants undergo fortnightly nucleic acid amplification testing on a multiplex assay including SARS-CoV-2, influenza A and B and RSV, regardless of symptoms. Questionnaires are completed every two weeks, capturing symptoms, sick days, exposures, and vaccination records. Serum samples are collected monthly or quarterly from participants associated with a SIREN site. This sub-study commenced on 28/11/22 to align with the predicted influenza season and participants' influenza vaccine status. The SIREN Participant Involvement Panel shaped the aims and methods for the study, highlighting its acceptability. UK devolved administrations were supported to develop local protocols. Analysis plans include incidence of asymptomatic and symptomatic infection, comparisons of vaccination coverage, assessment of sick day burden, and effectiveness of seasonal influenza against infection and time off work. Data are also integrated into UKHSA nosocomial modelling.

Ethics and dissemination: The protocol was approved by the Berkshire Research Ethics Committee (IRAS ID 284460, REC Reference 20SC0230) on 14/11/2022. Participants were informed in advance. As the frequency and method of sampling remained the same, implied consent processes were approved by the committee. Participants returning to the study give informed consent. Regular reports to advisory groups and peer-reviewed publications are planned to disseminate findings and inform decision making. Clinical trial registration number: ISRCTN11041050; registration date: 12 January 2021. Sub study included in protocol version: v8.0, and amended in v9.0.

Background: Alcohol use is the third leading risk factor of death and disability in the UK and costs the NHS £3.5 billion per year. Despite the high prevalence and healthcare burden of Alcohol-related Liver Disease (ArLD), there has been minimal research addressing prevention, morbidity and mortality. Reasons for this include stigma and lack of interest from public, charitable and commercial funding bodies. The objectives of this project were to identify and develop interdisciplinary partnerships, to explore stigma in ArLD, to develop a representative Patient and Public Involvement and Engagement (PPIE) group, to build research capacity, and to develop interdisciplinary research proposals targeting key research priorities.

Methods: ArLD networks were identified by members of the Project Steering Group. Health Care Professionals (HCPs) from different backgrounds were invited to join the ARMS-Hub. PPIE representatives were invited through charities and support groups. Research areas were identified, discussed, prioritised and ranked. Research questions were refined during an in-person symposium. A mentorship programme was created to encourage and facilitate networking and knowledge exchange for early career researchers.

Results: We established the ARMS-Hub with 31 HCPs and 40 PPIE members. There were five stakeholder meetings, which included PPIE representation. Three virtual and three in-person PPIE meetings took place. Topics relevant to stigma in ARLD identified during the meetings were education and awareness, language, and access. Priorities identified were the disconnect between mental health and liver services, education around the wider harms of alcohol, and education of HCPs regarding stigma. We established a mentorship network that regularly meets to support development of new research ideas.

Conclusions: Stigma is central to lack of research engagement from professionals and PPIE. The main priority identified relates to the disconnect between mental health and liver services. This collaborative study has allowed development of a research agenda to address this priority.

Background: Routine group and save (G&S) testing is frequently performed prior to cholecystectomy, despite growing evidence that a targeted approach is safe and avoids unnecessary investigations. This retrospective cohort study explored frequency of testing in our unit, rates of peri-operative blood transfusion and pre-operative risk factors for requiring transfusion.

Methods: Health records of 453 consecutive adults who underwent cholecystectomy in a UK NHS trust were reviewed for blood transfusion up to 30 days post-operatively. We compared the need for transfusion against patient demographics, indication and urgency of surgery, and the number of prior emergency hospital attendances with gallstone complications. Logistic regression determined whether prior attendances with complications of gallstones independently predicted the need for transfusion.

Results: Peri-operative blood transfusions within 30 days of operation occurred in 1.1% of cases, with no requirement for uncrossmatched blood. Patients who received a blood transfusion tended to have higher American Society of Anesthesiologists (ASA) grades ( p = 0.017), were more likely to have an underlying primary haematological malignancy (20.0% vs. 0.2%; p = 0.022) and prior emergency hospital attendances with gallstone complications (median 4 vs. 1; p < 0.001). Logistic regression showed each prior emergency attendance was associated with 4.6-fold odds of transfusion ( p = 0.019). Receiver operating characteristic curve analysis showed an area under the curve of 0.92. Three or more attendances predicted need for transfusion with 60.0% sensitivity and 98.0% specificity. 74% of patients had at least one G&S sample taken pre-operatively, costing the trust approximately £3,800 per year in materials.

Conclusions: The findings of this study suggest that pre-operative G&S testing prior to cholecystectomy is not routinely required. Increased frequency of prior emergency hospital attendances with gallstone complications and co-morbidities associated with coagulopathies were pre-operative risk factors for post-operative blood transfusion. More selective testing could provide large financial savings for health institutions without compromising patient safety.

Background: Self-harm in young people is a growing concern and reducing rates a global priority. Rates of self-harm documented in general practice have been increasing for young people in the UK in the last two decades, especially in 13-16-year-olds. General practitioners (GPs) can intervene early after self-harm but there are no effective treatments presently available. We developed the GP-led COPING intervention, in partnership with young people with lived experience and GPs, to be delivered to young people 16-25 years across two consultations. This study aims to examine the feasibility and acceptability of conducting a fully powered effectiveness trial of the COPING intervention in NHS general practice.

Methods: This will be a mixed-methods external non-randomised before-after single arm feasibility study in NHS general practices in the West Midlands, England. Patients aged 16-25 years who have self-harmed in the last 12 months will be eligible to receive COPING. Feasibility outcomes will be recruitment rates, intervention delivery, retention rates, and completion of follow-up outcome measures. All participants will receive COPING with a target sample of 31 with final follow-up data collection at six months from baseline. Clinical data such as self-harm repetition will be collected. A nested qualitative study and national survey of GPs will explore COPING acceptability, deliverability, implementation, and likelihood of contamination.

Discussion: Brief GP-led interventions for young people after self-harm are needed to address national guideline and policy recommendations. This study of the COPING intervention will assess whether a main trial is feasible.

Registration: ISRCTN (ISRCTN16572400; 28.11.2023).

Background: A priority setting partnership for eczema (syn atopic eczema, atopic dermatitis) has identified that bathing frequency is a key area of patient interest. However, there are nolarge, high-quality randomised controlled trials (RCTs) investigating this.The Rapid Eczema Trials project is a novel programme of research that aims to deliver multiple online RCTs, using a citizen science approach. This project involves working with members of the public to co-design and conduct studies that answer questions of importance to them. The first trial to be conducted through this project is assessing the impact of bathing frequency on eczema.

Methods: This is an online, two-arm, parallel-group superiority RCT with internal pilot phase. People aged ≥1 year with eczemaliving in the United Kingdom are eligible. Exclusion criteria are: people with other types of eczema such as venous eczema, hand eczema and contact eczema; recently started a new eczema treatment; taking part in another eczema trial; Patient Oriented Eczema Measure (POEM) ≤2; planning to swim more than twice a week; unable/unwilling to change bathing practices. Participants are allocated 1:1 to either the weekly bathing group (bathe 1 or 2 times a week) or the daily bathing group (bathe 6 or more times a week) for 4 weeks. The primary outcome is POEM, assessed weekly over 4 weeks. Secondary outcomes include skin specific quality of life, eczema control, itch severity, use of usual eczema treatments, proportion who achieve an improvement in POEM of ≥3 points, global change in eczema and safety outcomes. A sample of participants will also be invited to a semi-structured interview to discuss their experience. The primary comparative analysis will be according to randomised allocation regardless of actual frequency of bathing. The trial will be reported in accordance with CONSORT guidelines. The study has received ethical approval by the London - Surrey Research Ethics Committee (2 Redman Place, London, E20 1JQ, United Kingdom) on 11/10/2023 ( approval number: 23/PR/0899).

Trial registration: ISRCTN12016473, 22/11/2023, https://doi.org/10.1186/ISRCTN12016473.

Background: The Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) is designed to facilitate meaningful discussions between healthcare professionals, patients, and their family about preferences for treatment in future medical emergencies. People with a learning disability may face particular barriers in completing health care plans and receiving emergency treatment, however little is known about their preferences towards emergency care treatment planning. This study explores the views of people with a learning disability, and family carers about ReSPECT.

Methods: A reference group of 5 people with a learning disability contributed to the design of the workshops and evaluation of outputs. Online, arts-based interactive workshops were held with 2 groups of 6 people with a learning disability to explore how they felt about emergency care treatment planning, and to co-produce materials to support ReSPECT conversations. Carers of people with a learning disability participated in focus groups or interviews. Data from workshops, focus groups and interviews were analysed thematically.

Results: Themes were; Getting the Process Right, Lack of trust a barrier to ReSPECT planning, and Person-Centred Care. All groups supported the ReSPECT process feeling that ReSPECT plans could support person-centred care, enhancing the autonomy of a person with a learning disability and supporting the advocacy of carers. However, drawing on their previous experiences of the health care system some expressed doubt that their wishes would be carried out. Suggestions were made for improving the ReSPECT process and used to develop resources to support ReSPECT planning.

Conclusions: Emergency care planning and ReSPECT are viewed positively by people with a learning disability and family carers. To ensure this works well for people with a learning disability attention should be given to reasonable, personalised adjustments to support their participation in planning conversations. There is a wider challenge of fostering trust in the health care system.