NIHR open research最新文献

Background: Since the recent introduction of highly effective modulator therapies (HEMT), adults with cystic fibrosis (CF) have experienced significant health improvements. However, HEMTs can also lead to weight gain, and over 30% of adults living with CF, are now overweight or obese. The English National Health Service digital Weight Management Programme (NHS digital WMP) is offered to adults with obesity to support weight loss. This programme may not meet the complex health needs of people living with CF and may not address the established diet and physical activity behaviours that may contribute to weight gain in this population. Methods This paper outlines the steps to co-develop a CF-specific weight management programme (CF WMP), designed to be delivered alongside an NHS digital WMP. The CF-specific programme will be developed in collaboration with people with CF who have overweight or obesity (PwCF ^ow/ob) and professional stakeholders, using the three phases of the Person Based Approach (PBA); planning, co-designing and optimising. Planning Mixed-methods research with PwCF ^ow/ob and CF health care professionals will identify the barriers and facilitators to healthy eating and physical activity experienced by PwCF ^ow/ob. This will inform the guiding principles to underpin the co-design of the CF WMP and how it will address the dietary and physical activity behavioural needs of PwCF ^ow/ob to ensure it is engaging, acceptable and motivating. Co-design: a series of participatory workshops with PwCF ^ow/ob and key stakeholders will use guiding principles to specify design objectives and corresponding intervention features. Optimising: think aloud interviews with PwCF ^ow/ob will gather feedback on the CF WMP, to iteratively refine the programme.

Discussion: The resulting CF WMP will extend the usability of an NHS digital WMP to adults with CF, to better ensure it meets their needs, which have changed since the introduction of HEMT.

Background: Urinary tract infections (UTIs) are the most common serious bacterial infections in febrile infants. Current UK guidelines recommend parenteral antibiotics for infants under three months with suspected UTI, despite evidence supporting oral therapy in low-risk infants.

Objectives: To assess whether oral antibiotics are non-inferior to parenteral antibiotics for treating suspected UTIs based on treatment failure, need for additional therapy, and secondary outcomes.

Design: Multicentre, randomised controlled, open-label, non-inferiority trial with embedded internal pilot.

Setting: Twenty one paediatric emergency departments and assessment units across the UK.

Participants: Infants aged 29-90 days with suspected UTI, abnormal urinalysis, and low risk of invasive bacterial infection. Exclusion criteria included prematurity, prior hospitalisation, structural renal abnormalities, and clinical signs of sepsis or meningitis.

Interventions: Participants were randomised 1:1 to receive either oral antibiotics or standard care with intravenous (IV) antibiotics for 36-48 hours pending urine culture results.

Main outcome measures: The primary outcome was the requirement for additional parenteral antibiotics within seven days of randomisation. A range of secondary outcomes were also planned, including treatment failure, time to recovery, adverse events, antibiotic adherence, quality of life, family impact, and healthcare resource use.Feasibility outcomes collected during the internal pilot included recruitment rate, site activation, protocol adherence, and retention. Clinical outcomes were collected but not powered for formal comparison.

Results: 27 participants were recruited between 20 May 2024 and 13 March 2025 (which included the 6 month internal pilot), representing 27% of the pilot target. Protocol adherence was high, and no cases of meningitis occurred. Two cases of bacteraemia (one per randomised group) had uncomplicated clinical courses. Oral therapy was associated with shorter hospital stays and reduced parental time off work.

Conclusions: While trial procedures were successfully implemented, recruitment challenges suggest that a larger randomised trial of this treatment comparison is not feasible in this setting.

Trial management: Northern Ireland Clinical Trials Unit (NICTU).

Trial registration: ISRCTN Clinical Trials Registry, ISRCTN10907780, Trial Dates 20 May 2024 to 13 March 2025.

Background: Maternal mortality rates show disproportional disparities among disadvantaged groups.

Objective: To conduct an overview of qualitative systematic reviews to summarise the antenatal care experience of ethnic minority and underserved, marginalised and disadvantaged women in high-income countries.

Search strategy: Seven electronic databases were searched to identify reviews published between 2011-2022.

Selection criteria: Two reviewers independently screened search results and full texts of potentially eligible articles.

Data collection and analysis: Data were extracted by two independent reviewers, critically appraised using the JBI tool and assessed for overlap. A thematic analysis was conducted.

Main results: Nineteen qualitative reviews were included. Most were conducted in the UK (n=12) and provided a thematic synthesis of findings. Studied populations included women from minority ethnic groups and those who were migrants, homeless, refugees, asylum seekers, disabled, obese, or had experienced genital mutilation or human trafficking. Common challenges included language and cultural differences, and lack of effective interactions with healthcare professionals. Many women experienced discrimination, isolation, limited awareness of available services and negative attitudes from maternity care staff. Limited access to maternity services was influenced by various factors, including costs and communication barriers. Positive experiences included interactions with culturally responsive healthcare professionals, support from social groups, and access to interpreters.

Conclusions: Our findings highlight the complex challenges some women face during maternity care. Future research should focus on more personalised care solutions, long-term evaluations of maternity services, training of healthcare professionals, and ways to improve the quality of information provided and the interaction with healthcare professionals.

Background: Despite having high maternal mortality, no recent confidential enquiry into maternal deaths (CEMD) has been implemented in Ethiopia. This paper outlines the introduction of the CEMD, major findings, and key methodological considerations.

Methods: We embedded this CEMD in the ongoing Ethiopian Obstetric Surveillance System (EthOSS), a regional system that monitors a range of major obstetric conditions in eastern Ethiopia. Multiple methods (both qualitative and quantitative) were used to collect, analyse and report the data. A multidisciplinary committee was established and trained on principles and methodology of CEMD by international experts. The CEMD committee conducted two plenary CEMD sessions to review maternal deaths reported from April 1, 2021, to March 31, 2022, from 13 hospitals in the EthOSS consortium. Each case was assessed for causes, contributing factors, delays in care using the three-delays model, preventability, and recommendations for improving care.

Results: Out of 70 maternal deaths, in 59 there was enough information to enable a review by the committee; 27/59 (46%) and 15/59 (25%) were caused by obstetric haemorrhage and hypertensive disorders of pregnancy respectively. In 55/59 (93%), at least one of the three delays was identified: delay one (seeking care) in 48 (81%), delay two (reaching an appropriate facility) in 52 (88%), and delay three (receiving adequate care) in 54 (92%). The review indicated that almost all reported deaths could have been prevented with better care.

Conclusions: Almost all the maternal deaths in the region were considered preventable. Training for improving providers' clinical skills, improving availability of blood and basic supplies, strengthening postpartum monitoring, and referrals were recommended for saving lives through reducing preventable maternal deaths.

Background: Communities of Practice (COP) are recognised as shared learning spaces that situate learning, deepen knowledge, and facilitate the exchange of expertise within a specific domain. While CoPs often emerge organically, they have been widely adopted across health, social care, and education. However, their civic potential, particularly in enabling people with lived experience of social care to collaborate with practitioners to shape practice and drive meaningful change, remains underexplored.The Kent Research Partnership, South-East England (2021-5), aimed to build research capacity in adult social care. As part of its workstreams two COPs were co-designed with informal carers and people who draw on care and support. The themes ('Complex needs' and 'Workforce') were co-developed by a prioritisation exercise. Each COP had monthly online sessions with invited speakers and facilitated discussions. Participants included informal carers, people who draw on care/support, social care practitioners, researchers, and other people interested in the sector.

Methods: This study evaluated the COPs and their contribution to research capacity building in Kent. Using a pragmatic approach, 21 participants were purposively selected and interviewed.

Results: Reflexive thematic analysis generated three key themes: fostering an inclusive and collaborative learning environment; enabling shared learning within and beyond the COPs; and generating shared impact through influence on policy and practice. These findings were mapped against Cooke's (2005) framework for building research capacity.

Conclusions: Participants valued the inclusive and safe learning space, which supported mutual reflection and knowledge exchange. Relationships formed across roles and settings which helped bridge siloed thinking, validate research ideas, and extend learning beyond the COPs. Time constraints and organisational culture affected frontline social worker participation, despite a recognised need for innovation. Networking emerged as a prominent outcome, leading to new knowledge-exchange collaborations. Future research should focus on understanding the impact of the COPs on organisational level practice and policy.

Background: Engaging relevant stakeholders throughout the research cycle is increasingly recognised as critical to conducting quality health systems research. There are few descriptions and analyses of stakeholder engagement in practice for embedded health systems research especially those that must navigate multi-level decentralised health systems. We describe and reflect on the stakeholder engagement activities of an international multi-disciplinary programme of research focused on newborn care in hospitals in Kenya.

Methodology: Our experienced project stakeholder engagement group coordinated engagement activities across multiple stakeholders ranging from those close to the intervention to those further away. with differing interests in the research. We conducted a stakeholder mapping and analysis using an engagement matrix to include national and county-level policymakers, professional communities, associations and regulators, health managers, frontline healthcare workers, patients, families and patient representative groups. Our engagement group maintained a log of engagement activities and had regular programme feedback meetings. Our analysis of stakeholder engagement drew on Programme's documents and meeting minutes, and on a conceptual framework which distinguishes between the moral, strategic and practical dimensions of stakeholder engagement.

Results: We engaged a wide range of stakeholders based on our understanding of their needs, interests and concerns. We drew on the International Association for Public Participation model on encompassing 'inform', 'consult,' 'involve,' 'collaborate', and 'empower' to inform strategies of engaging stakeholders and the need to balance moral, strategic and pragmatic components of engagements. Although we had significant prior engagement experience and relationships at the hospitals and the counties, introducing new staff into Newborn Units triggered complexities that required careful consultation along the bureaucracies at the counties. Despite the counties having similar hierarchical architectures, engagement processes varied and achieved different research approval, recruitment of additional workforce and outcomes across counties. There were also multiple officeholder transitions over the research period, occasioned by factors in our external environment, often necessitating engaging afresh.

Conclusion: Even with a carefully developed stakeholder engagement plan, an experienced team, and a landscape backed by long-term relationships and embeddedness, health research stakeholder engagement can be complex and unfold in unexpected ways and requires continuous effort, resources, and adaptability. Meeting the moral, strategic, and practical potential of engagement requires flexibility, responsiveness, and commitment, including adequate resources.

Background: High blood pressure (BP) affects more than one in four adults in England and only one in three patients are being treated effectively. Treatment of high BP includes changes to lifestyle such as more physical activity and/or taking medication. However, low adoption and high attrition rates are common with current large targets for recommended exercise (>150 minutes moderate exercise per week plus 2 strength sessions). Evidence suggests that isometric exercise (IE), holding a fixed body position for a period of time, for example a wall squat, lowers BP a greater amount, with less time and effort, than other recommended exercise. This ISOFITTER study will provide robust effectiveness evidence of IE for hypertension.

Methods: A multi-centre, randomised, controlled trial of isometric exercise wall squat intervention for hypertension: an effectiveness-implementation hybrid type-1 design. Adults (n=542) with Stage 1 or Stage 2 hypertension, on no more than one antihypertensive, and no other medical contra-indications will be randomised to either a standard care plus IE intervention group or standard care control group. Blood pressure readings, fidelity measurements, medications, adverse events, quality of life, participant satisfaction and health service use will be collected at baseline, week 4, month 3 and month 6 with a subgroup of n=50 invited up to month 12. Qualitative participant focus groups and interviews with wider stakeholders will collect implementation data.

Results: The ISOFITTER study will establish effectiveness of a self-administered, home IE intervention in lowering blood pressure in people with uncomplicated stage 1 and 2 hypertension. Implementation evidence will support patient delivery, context for scaling up of the intervention and intervention cost.

Conclusion: Lifestyle changes for the treatment of hypertension in the absence of other risk factors should not be overlooked. For long term hypertension management, easily adopted, evidenced exercise interventions are needed. This study will help to address this evidence gap.

Introduction: In 2021 we launched the BronchStart study, which collected information on 17,899 hospital attendances in children with serious respiratory tract infections following the release of lockdown restrictions. Our study informed the Joint Committee on Vaccination and Immunisation's (JCVI) decision to recommend the introduction of maternal respiratory syncytial virus (RSV) vaccination, which was rolled out in the United Kingdom in August/September 2024 for all pregnant women at a gestation of 28 weeks or more. That winter we performed the BronchStop study, which examined vaccine effectiveness in its first season, conducted a survey of mothers to understand factors affecting vaccine uptake, and collected RSV positive samples for molecular epidemiology.

Methods and analysis: In the winter season of 2025-2026 we will conduct a UK-wide, multi-centre, prospective, test-negative case control study. The aim is to assess the effectiveness of maternal RSV vaccination against hospitalisation for RSV-associated acute lower respiratory tract infection (ALRI) amongst infants under the age of 6 months born to vaccine-eligible pregnant mothers. A survey designed in partnership with our public and patient involvement (PPI) group will be administered to mothers of recruited infants to understand factors affecting maternal vaccine uptake. RSV-positive samples will undergo whole genome sequencing, and all samples will undergo real-time, reverse transcriptase polymerase chain reaction (rRT-PCR) testing for a panel of respiratory viruses to understand residual causes of severe infant respiratory disease in the post-vaccination era.

Ethics and dissemination: Participants recruited to the study will be asked for informed consent to participate in the maternal survey, for researchers to access their vaccination records, and for routinely collected virological samples from their infants to undergo rRT-PCR testing. Regular reports to advisory groups, including JCVI and the World Health Organisation, and for peer-reviewed publications are planned to disseminate findings and inform decision-making.

Background: In addition to new antimicrobials for people with Cystic Fibrosis (pwCF), new diagnostics are needed to detect and diagnose infections, guide clinical care, and inform clinical decision making. To determine unmet diagnostic needs in pulmonary infection and exacerbation diagnostics in Cystic Fibrosis (CF), the required diagnostic test characteristics and priorities of different stakeholders involved in the care of pwCF were collected and analysed.

Methods: Three focus groups (two clinical and one pwCF) were conducted and used to inform a wider project to deliver a suite of target product profiles (TPPs) for CF lung microbiological infection and/or exacerbation diagnostics. Thematic analysis was performed on the focus group data.

Results: Participants described their experience of current practice and existing diagnostics for detection, diagnosis, and management of infection and exacerbations in CF in the UK National Health Service (NHS). Unmet needs included: monitoring modalities and testing for treatment efficacy; acquiring samples with good clinical utility; more acceptable sampling methods; and faster microbiology and culture-based testing.Greater communication between the laboratory and clinical teams, and equity of care across UK CF centres was also highlighted. TPP characteristics of importance to pwCF and clinical representatives included 'accuracy', 'time to results', and 'patient acceptability'. Both participants groups highlighted the need for suitable alternatives to sputum sampling and emphasised the need for novel biomarkers for the early detection and diagnosis of both infection and exacerbations. Amongst clinical representatives, test accuracy was generally valued over the time to results for a clinical test in a non-acute setting.

Conclusions: Focus groups offered rich and detailed insights into the opinions of clinical staff and pwCF alike which informed further stakeholder engagement and shaped the content, scope and characteristics of TPPs. Early and rapid detection would have a positive impact on clinical care and inform earlier clinical decision making.

Background: The National Institute for Health and Care Research (NIHR) is the UK's biggest funder for health and social care research, funded by the Department of Health and Social Care (DHSC). The NIHR infrastructure provides research expertise, specialist facilities, a research delivery workforce and support services, all of which help to support and deliver the research we fund, and research funded by others. The NIHR is committed to maximising the impact of the research we support and fund ¹ and therefore, it is crucial for the organisation to understand the mechanisms for the movement of research between these different pieces of research infrastructure and pathways to impact on the health and wealth of the nation. The aim of this article is to share our approach to developing an understanding of pathways to impact, enablers and barriers and lessons learnt.

Methods: We used publications reported to us by our infrastructure as receiving infrastructure support and forward and backward citation analysis to trace infrastructure support for REF 2021 impact case studies and research that has had an impact on policy. We used these data to develop impact case studies for NIHR infrastructure.

Results: Of the 6,361 REF impact case studies that are publicly available, the NIHR infrastructure has supported 327 of which 59 are supported by more than one scheme. Through our forward and backward citation analysis we have also developed impact case studies in the following NIHR priority areas:Reducing health inequalitiesDigital healthArtificial intelligenceWorkforce resilience.

Conclusions: The use of forward and backward citation analysis can also help research funders to understand how research is moving between different parts of their funding portfolios, pathways to impact and any gaps and opportunities. However, this comes with some challenges which need mitigation.