NIHR open research最新文献

Background: A gap exists in the provision of care for imprisoned women with Severe Mental Illness (SMI), both in prison and on release to mainstream primary care. Women in such settings tend to have complex mental health problems, often with comorbid long-term physical health conditions (LTCs). These problems are compounded in women who are racially minoritised. The prison regime can be a barrier to addressing health needs of women: limited time out of cell and depletion of staff resources. Little is known about how imprisoned women with SMI use prison primary care services, to what extent services meet health care needs, and how services are experienced by different ethnic groups.

Aims: 1. To explore the range of primary care services delivered to imprisoned women with severe mental illness (SMI) in England and describe what is working well and the barriers to accessing care.2. To develop a framework for use in women's prison services to support the primary care of racially minoritised women with SMI.

Methods: The proposed study comprises of three phases across female prisons in England. Purposive sampling will be used to capture different prison groupings.Phase 1: Semi-structured telephone/online interviews with prison primary care practitioners.Phase 2: Focus groups / one to one dicussions with imprisoned women with SMI, including women from a range of ethnic groups.Phase 3: Consensus groups with prison healthcare and non-clinical staff.

Patient and public involvement ppie: Co-applicant PH will be the PPIE lead, as a lived experience researcher, who supports engagement with imprisoned communities and PPIE in research. She will recruit and facilitate meetings with an ethnically diverse Lived Experience Advisory Group (LEAG), supporting members to participate in the Research Steering Group (RSG) that monitors study progress. She will be supported by Co-applicant HK who has expertise in supporting PPIE in engagement and participation in research.

Isrctn registry: ISRCTN10216673.

Background: Of the 150 000 people per year in the UK who have strokes, third to half will experience a so-called 'minor stroke'. Although appearing benign these strokes put a person at increased risk of further strokes and survivors are usually considered 'too good' for referral onto community stroke services. When back at home the hidden effects of stroke like fatigue and changes in mood and cognition become apparent and impact return to work, relationships and everyday activities. Alongside this, managing the risk of recurrence, highest early after an initial stroke, is a priority. People with stroke report feeling abandoned after discharge with unmet information and support needs.

Methods: To address this issue, we reviewed the literature, met with people with stroke and other stakeholders to develop an early, personalised follow-up programme of care for those who currently only receive routine medical follow-up appointments. The design of this complex intervention is informed by the NIHR/MRC framework for complex intervention development and the framework of action described by O'Cathain and colleagues. The intervention is underpinned by self-determination theory. We will be conducting a randomised, mixed methods, single-centre feasibility study to explore the acceptability and feasibility of the intervention. Sixty participants will be recruited from a Hyperacute Stroke Unit and Rapid Assessment Clinic and randomised to the intervention or control group. The intervention group will receive personalised follow-up appointments at two- and six-weeks post-discharge. All participants will have outcome measures taken at baseline and twelve-weeks post-stroke. Patient reported outcomes will be reviewed to assess their suitability for a later definitive trial. Qualitative interviews will be conducted to gain a deeper understanding of life after stroke from those who did and did not receive the intervention.

Conclusions: Study findings will be used to further refine the intervention, methods and outcome measurements used. These refinements will inform a future multicentre randomised controlled trial.

Background: Epilepsy affects one percent of the UK population and is the most common serious neurological condition experienced during pregnancy. We compared the characteristics, clinical management, and pregnancy outcomes in women with severe, uncontrolled epilepsy to those of women with well controlled disease.

Methods: We conducted a population-based case-control study in all UK consultant-led maternity units. Cases of severe uncontrolled epilepsy during pregnancy were identified prospectively and reported via the UK Obstetric Surveillance System (UKOSS). Severe epilepsy was defined a-priori as ≥1 of the following: admission to hospital during pregnancy to manage seizures; prescribed ≥3 antiepileptic medications; or died from epilepsy. Controls comprised women with epilepsy not meeting the case definition, identified within the same centres as cases. Pre-pregnancy epilepsy control and pregnancy outcomes were compared between groups using multivariable logistic regression.

Results: We identified 94 cases between 1 October 2015 and 31 March 2017 and compared these with 186 controls. Cases were significantly more likely to be admitted to manage seizures in the year preceding pregnancy (42/94 cases vs 10/186 controls, adjusted odds ratio [aOR]=7.38 [95% CI 2.70-20.2]), and to report their most recent seizure within 3 months of pregnancy (51/94 cases vs 18/186 controls, aOR=5.86 [95% CI 2.30-15.0]). Cases were significantly more likely to deliver before 37 weeks (20/94 cases vs 8/186 controls, aOR=7.61 [95% CI 2.87-20.2]).

Conclusions: Women admitted for seizure management in the year before pregnancy are at higher risk of severe epilepsy during pregnancy and of preterm birth. These women should be prioritised for discussion about pregnancy and contraception. When pregnant, they should be reviewed as early as possible by specialists in the management of epilepsy during pregnancy. Delivering messages about the importance of pregnancy planning and contraception to all women with epilepsy should be viewed as the responsibility of all clinicians involved their care.

Background: Each year in England, 450,000 children and young people (CYP) under 18 years of age are transported by ambulance to emergency departments. Approximately 20% of these suffer acute pain caused by illness or injury. Pain is a highly complex sensory and emotional experience. The intersection between acute pain, unwell CYP and the unpredictable pre-hospital environment is convoluted. Studies have shown that prehospital pain management in CYP is poor, with 61% of those suffering acute pain not achieving effective pain relief (abolition or reduction of pain score by 2 or more out of 10) when attended by ambulance. Consequences of poor acute pain management include altered pain perception, post-traumatic stress disorder and the development of chronic pain. This realist review will aim to understand how ambulance clinicians can provide improved prehospital acute pain management for CYP.

Methods: A realist review will be conducted in accordance with the Realist And Meta-narrative Evidence Syntheses: Evolving Standards (RAMESES) guidance. A five-stage approach will be adopted; 1) Developing an Initial Programme Theory (IPT): develop an IPT with key stakeholder input and evidence from informal searching; 2) Searching and screening: conduct a thorough search of relevant research databases and other literature sources and perform screening in duplicate; 3) Relevance and rigour assessment: assess documents for relevance and rigour in duplicate; 4) Extracting and organising data: code relevant data into conceptual "buckets" using qualitative data analysis software; and 5) Synthesis and Programme Theory (PT) refinement: utilise a realist logic of analysis to generate context-mechanism-outcome configurations (CMOCs) within and across conceptual "buckets", test and refine the IPT into a realist PT.

Conclusion: The realist PT will enhance our understanding of what works best to improve acute prehospital pain management in CYP, which will then be tested and refined within a realist evaluation.

Registration: PROSPERO Registration: CRD42024505978.

Background: The number of people living with multiple chronic conditions in sub-Saharan Africa is increasing, but health facilities are unable to meet demand. To improve health system capacity and access to care, community models of HIV care have been trialled in countries such as Tanzania and Uganda. However, no evidence exists to inform policymakers on the effectiveness and cost-effectiveness of integrated community-based models of care for HIV and chronic non-communicable conditions. This protocol outlines a within-trial economic evaluation to address this gap.

Methods & analysis: We will estimate the costs and cost-effectiveness of integrated community-based care for HIV, hypertension and diabetes compared with facility-based care within the INTE-COMM pragmatic cluster-randomised trial in Tanzania and Uganda. Analyses will adopt a 52-week time horizon, the duration of trial follow-up. The full enrolled trial sample will be analysed from a societal perspective, comprising provider and patient perspectives. Economic costs will be estimated, which includes valuing inputs such as donated goods or time foregone by participants because of receiving care. For provider costs, participant case report forms will inform resource use along with data from facilities and community sites. Resources will be valued using project accounts, facility spending, and locally available cost data. Patient costs will be estimated based on a care-seeking and cost questionnaire administered to participants. Estimated costs will be analysed with co-primary trial outcomes on plasma viral load suppression, glycaemia and blood pressure control to calculate incremental cost-effectiveness ratios (ICER). We will also calculate ICERs for secondary trial outcomes related to health-related quality of life and wellbeing. Cost drivers and outcomes will be varied within confidence bounds in a two-way sensitivity analysis. We will investigate equity impact by estimating the mean difference in outcomes between integrated community-based and facility-based care across household socio-economic quintiles and by measuring whether participants incurred catastrophic health expenditures.

Trial registration number: The ISRCTN Registry: ISRCTN15319595. Registered on 07 June 2022: https://doi.org/10.1186/ISRCTN15319595.

Background: PROTECT ( Platform Randomised evaluation of clinical Outcomes using novel TEChnologies to optimise antimicrobial Therapy) has brought together a team of researchers to design a platform trial to rapidly evaluate and adopt into care multiple diagnostic technologies, bringing immediate benefit to patients. Rapid diagnostic tests will be used to identify patients at risk of deterioration from severe infection, before they become critically unwell. The platform will assess their comparative clinical effectiveness and cost-effectiveness relative to current standard of care. Preliminary work, conducted under a Health Technology Assessment Application Acceleration Award, provided key evidence to optimise the design of the PROTECT platform.

Methods: Qualitative methods which involved consulting key stakeholders in the field of serious infection addressed the key priorities. A high-level care pathway analysis focusing on serious infection in secondary care, captured the points of contact, actions, decisions, and potential outcomes associated with a patient's care.

Results: Two use cases of rapid diagnostic tests for serious infection were identified; (1) in acute emergency medicine to decide on antimicrobial initiation and/or escalation of care, and (2) in hospitalised patients to monitor treatment response. The "ideal" test should be rapid, point-of-care, cheap to procure, have capacity for high usability, and ability to be performed and interpreted by all staff. Facilitators to the adoption of infection diagnostic tests is their clinical need, and the main potential barrier is poor change management and behavioural change.

Conclusions: Any new test should provide robust evidence of its clinical effectiveness and have the potential to accelerate ruling in or out serious infection which benefits the clinical pathway for patients, clinicians, and hospitals as a whole, to be considered for adoption as a new standard of care.

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: Pulmonary aspiration of gastric contents is the most frequent cause of death associated with complications of airway management during general anaesthesia. Pregnancy increases aspiration risk owing to factors including delayed gastric emptying and increased intragastric pressure. We describe the incidence, risk factors, management, and outcomes of maternal pulmonary aspiration in pregnancy in the UK.

Methods: We conducted a population-based surveillance and case-control study. Between September 2013 and August 2016, all UK consultant-led obstetric units prospectively identified cases of pulmonary aspiration among parturient women using a pre-defined case definition, and reported them via the UK Obstetric Surveillance System (UKOSS). Controls (n=1982) were obtained from four UKOSS studies conducted between 2005 and 2014. We calculated the incidence of pulmonary aspiration using 2013-2015 maternities as the denominator. We explored potential risk factors for aspiration using univariable logistic regression and described outcomes.

Results: We identified 12 cases of pulmonary aspiration, giving an incidence of 5.2 per 1,000,000 maternities (95% CI 2.69-9.09). Cases were significantly less likely than controls to be multiparous (unadjusted odds ratio [uOR] 0.255, 95% CI 0.069-0.946), and significantly more likely to undergo caesarean section (uOR 24.89, 95% CI 3.18-194.85) and to receive general anaesthetic for caesarean section (p<0.001). Gestation was significantly shorter in cases than controls (uOR 0.782, 95% CI 0.702-0.870). Women who aspirated were significantly more likely to be admitted to the intensive therapy unit than controls (p<0.001). Infants of women who aspirated had significantly lower Apgar scores and were more likely to be admitted to the neonatal intensive care unit or to be stillborn compared with infants of women in the control group.

Conclusions: Pulmonary aspiration is rare in UK obstetric anaesthetic practice; however, it remains a risk of general anaesthesia. Despite a large study population, our analyses lacked power to evaluate many potential risk factors. Future research should focus on developing methods to accurately identify pregnant women at risk of aspiration.

Background: The incidence of breast cancer first arising during pregnancy has been estimated in several countries to be 2.4-7.8/100,000 births, but has not been established in the United Kingdom (UK). We aimed to estimate the incidence of breast cancer diagnosed during pregnancy in the UK and to describe its management and short-term outcomes for mothers and babies.

Methods: This population-based descriptive study used the UK Obstetric Surveillance System (UKOSS). Cases were prospectively identified through monthly UKOSS mailings to all UK consultant-led maternity units. All cases of breast cancer diagnosed first during pregnancy, between October 1, 2015, and September 30, 2017, were eligible, with 84 confirmed cases analysed. Women with breast cancer diagnosed before pregnancy or with a recurrence were excluded. The primary outcomes were the incidence of breast cancer first diagnosed during pregnancy, maternal mortality, severe maternal morbidity, perinatal mortality, and severe neonatal morbidity.

Results: The incidence was 5.4/100,000 maternities (95% CI 4.37, 6.70). Nine women (11%) had undergone in vitro fertilisation (IVF), compared with a contemporaneously estimated 2.6% IVF pregnancies in the UK. During pregnancy, 30 women (36%) underwent surgery and 37 (44%) received chemotherapy. Three women had major maternal morbidity during pregnancy. Two women died and two perinatal deaths occurred.

Conclusions: The incidence of breast cancer arising in pregnancy in the UK is similar to that reported elsewhere. The higher proportion of IVF pregnancies among affected women needs further investigation, as it may not be entirely explained by relatively advanced maternal age. With caveats, management followed that outside pregnancy, but there was considerable variation in practice. Although short-term outcomes were generally good for mothers and babies, a larger prospective study is required. Iatrogenic pre-term delivery and its associated risks to the infant can often be avoided; treatment was administered during pregnancy without evidence of harms to the infant.

Aims: To conduct a scoping review of health economic evaluations of antimicrobial stewardship programmes (ASP). Our purpose was to summarise findings and to review different approaches taken.

Methods: We reviewed economic evaluation studies retrieved from a number of sources, assessing the costs and effects of ASP. We described and synthesised data from studies published between 2002 and 2023 that included measures of both costs and effects/benefit of interventions.

Results: Eight studies met the inclusion criteria. Six studies estimated cost-effectiveness, and two studies assessed cost utility. We found no cost-benefit studies. One of the studies was based on a randomised controlled trial. None of the studies took a broad perspective to include societal benefits that might arise from less resistant organisms on the environment contingent on reductions of prescriptions of broad-spectrum antibiotics.

Conclusion: Limited evidence on the cost-effectiveness of Antimicrobial Stewardship Interventions studies suggests that the implementation of strategies to reduce antimicrobial resistance is worth the investment. However, producing a summary measure of ASP interventions is limited not just by the paucity of studies, but also heterogeneity of intervention types, variation in the implementation contexts and different methodological approaches.