Conectar
Inherited retinal diseases (IRDs) are a broad range of diseases associated with abnormalities/degeneration of retinal cells. We aimed to identify the top 10 Australian research priorities for IRDs to ultimately facilitate more meaningful and potentially cost-effective research.
We conducted a James Lind Alliance priority setting partnership that involved two Australian-wide surveys and online workshops.
Australia-wide.
Individuals aged 16 years or older were eligible to participate if they had an IRD, were caregivers of an individual with an IRD or were health professionals providing care to this community.
In Survey 1, we gathered participants’ unanswered questions about IRDs. We grouped these into summary questions and undertook a literature review to verify if they were truly unanswered (ie, evidence uncertainties). In Survey 2, participants voted for the uncertainties that they considered a priority. Top-ranked uncertainties progressed for discussion and final prioritisation in two workshops.
In Survey 1, we collected 223 questions from 69 participants. We grouped these into 42 summary questions and confirmed 41 as evidence uncertainties. In Survey 2, 151 participants voted, with the 16 uncertainties progressing to final prioritisation. The top 10 priorities, set by the 24 workshop participants, represented (1) treatment/cure; (2) symptoms and disease progression; (3) psychosocial well-being and (4) health service delivery. The #1 priority was for treatment to prevent, slow down or stop vision loss, followed by the #2 priority to address the psychological impact of having an IRD.
The top 10 research priorities highlight the need for IRD research that takes a whole-person, systems approach. Collaborations to progress priorities will accelerate the translation of research into real-world benefits.
Structural MRI of the brain is routinely performed on patients referred to memory clinics; however, resulting radiology reports, including volumetric assessments, are conventionally stored as unstructured free text. We sought to use natural language processing (NLP) to extract text relating to intracranial volumetric assessment from brain MRI text reports to enhance routine data availability for research purposes.
Electronic records from a large mental healthcare provider serving a geographic catchment of 1.3 million residents in four boroughs of south London, UK.
A corpus of 4007 de-identified brain MRI reports from patients referred to memory assessment services. An NLP algorithm was developed, using a span categorisation approach, to extract six binary (presence/absence) categories from the text reports: (i) global volume loss, (ii) hippocampal/medial temporal lobe volume loss and (iii) other lobar/regional volume loss. Distributions of these categories were evaluated.
The overall F1 score for the six categories was 0.89 (precision 0.92, recall 0.86), with the following precision/recall for each category: presence of global volume loss 0.95/0.95, absence of global volume loss 0.94/0.77, presence of regional volume loss 0.80/0.58, absence of regional volume loss 0.91/0.93, presence of hippocampal volume loss 0.90/0.88, and absence of hippocampal volume loss 0.94/0.92.
These results support the feasibility and accuracy of using NLP techniques to extract volumetric assessments from radiology reports, and the potential for automated generation of novel meta-data from dementia assessments in electronic health records.
Mycobacteroides abscessus (MABS) is within the non-tuberculous mycobacteria family. It inhabits soil and water, exhibits multi-antibiotic resistance and causes opportunistic lung infections, which may progress to symptomatic MABS-pulmonary disease (MABS-PD) associated with substantial morbidity, increased healthcare utilisation, impaired quality of life and increased mortality. Treatment regimens for MABS-PD are highly variable, not evidence-based and involve complex, expensive drug combinations administered for prolonged periods (>12 months) with frequent adverse effects and treatment failure. There is an urgent need for safe, efficacious and cost-effective MABS-PD therapy. Here, we describe the Master Protocol for the Finding the Optimal Regimen for Mycobacteroides abscessus Treatment (FORMaT) trial. FORMaT aims to determine the most effective and best tolerated treatment for MABS-PD as defined by MABS clearance from respiratory samples with good treatment tolerance.
FORMaT is an international multicentre, adaptive platform trial evaluating treatment combinations for MABS-PD. Participants are randomised multiple times during the trial, with assessment of the primary outcome of clearance of MABS infection with good treatment tolerance. Initially, therapies recommended in international consensus guidelines are being tested. Data obtained will eliminate therapies lacking efficacy or causing unacceptable toxicity. Novel treatments can then be added and tested against previously determined optimal approaches, leading in an iterative fashion to improved microbiological clearance and health outcomes. In parallel, an Observational cohort and several integrated and discovery studies are embedded in FORMaT to identify biomarkers of MABS-PD and MABS clearance, clinical and radiographic treatment response, drug pharmacokinetics and Mycobacteroides genomics and resistome.
The FORMaT Master Protocol and related documents are approved by regulatory authorities in each participating jurisdiction and/or site. Results will be published in peer-reviewed journals and presented at scientific meetings. De-identified, aggregated data will be shared on an approved online platform.
NCT04310930, ANZCTR12618001831279, 2020-000050-10,
Traumatic brain injury (TBI) is a leading cause of mortality and disability worldwide. In the USA, individuals who racially identify as African American or Black experience disproportionately higher rates of TBI and sustain worse prognosis compared with White patients; however, this population continues to be under-represented in contemporary translational research agendas. This protocol aims to comprehensively evaluate and synthesise what is currently known about the molecular epidemiology of TBI outcome among individuals of Black racial identity or African ancestry.
This review will use the established scoping review framework from the Joanna Briggs Institute. The search strategy will be implemented in PubMed (MEDLINE) and expanded to Embase and Cochrane CENTRAL Library (Wiley) databases in the final review. The date range will span from database inception to 20 July 2025 (date of final search). A two-stage screening process will be performed first at the title and abstract level before full-text assessment. Screening will be performed by two independent reviewers and discrepancies will be reconciled by a third reviewer. Articles that meet the following inclusion criteria will be considered: we will include human studies that investigate molecular and biochemical markers associated with TBI outcome. Studies must include individuals who are (A) of Black or African American racial identity, (B) of African ancestry and/or (C) performed in Sub-Saharan African countries. There is no eligibility criteria related to participant age, sex or gender. Eligible studies will be limited to English, Spanish or French. Data extracted from will be analysed and presented as written narrative, summary statistics of study characteristics and graphical or tabular displays.
Ethical approval is not required for this scoping review. The results of this review will be disseminated through peer-reviewed publications and academic conferences.
The purpose of this article is to share insights from the National Institute for Health and Care Research Clinical Research Network (NIHR CRN) in delivering research for Multiple Long Term Conditions (MLTC) and to highlight lessons of wider relevance across the research ecosystem.
Designing health and care systems to be more responsive to the needs of people living with MLTC requires a considerable evidence base. When compared with research focused on a single disease area, research relating to MLTC raises unique considerations at the stages of planning, placing, and delivering research studies. Our article describes challenges associated with MLTC research outcomes and outlines different types of interventions to target MLTC, along with related research delivery considerations. Our article also raises important considerations for placing research in the most appropriate setting and highlights the vital role of robust feasibility studies, informed by the lived experience of patients and carers with MLTC, for ensuring that studies are conducted, recruited to, and completed in a timely and appropriate way.
Increasing the evidence base for the prevention and management of MLTC is a necessity for our health and care system. This presents novel challenges that require collaboration between multiple stakeholders. The UK benefits from a unique research infrastructure, including support for the stages of planning and delivery of health and care research. As the health and care system moves towards bringing care closer to patients and service users, the appropriate selection of the health and care settings and research sites in which to deliver MLTC research, in addition to understanding and removing barriers to recruitment and participation for people with MLTCs, are important considerations to enable us to collectively respond to this challenge.
To identify and critically appraise instruments that have been used to measure nurse resilience.
A scoping review.
Comprehensive literature searches were conducted using four electronic databases CINAHL Ultimate, MEDLINE, PsycINFO and Emcare from the year 2012 to December 2024.
The titles, then abstracts, of retrieved articles were screened by the authors against inclusion and exclusion criteria, then full-text screening was performed using Rayyan. Data about the study characteristics and the instruments used to measure nurse resilience were extracted. Copies of the instruments used to measure resilience were obtained and appraised.
Of the n = 4694 publications identified in the initial search n = 386 were included in the scoping review. Studies originated in n = 45 countries, the majority were conducted in China (n = 119) and the United States of America (n = 53). Across the n = 386 included studies, n = 15 instruments to measure resilience were identified and critically appraised. The scores for the instruments critically appraised ranged from 0 to 6 out of a total possible score of 11. Synthesis of results examined instrument development, instrument features and application of instruments.
Critical appraisal of the instruments used to measure nurse resilience revealed significant deficiencies. None of the instruments included all of the key attributes and factors that influence nurse resilience. There was a predominant focus on individual factors and little consideration of the influence of nursing work environments. Due to the shortcomings of the existing instruments, there are currently substantial limitations in our understanding of nurse resilience and how to measure it.
A profession-specific comprehensive measure of nurse resilience needs to be developed to better capture the attributes of nurse resilience.
This review highlights the limitations of instruments applied to measure nurse resilience.
The JBI scoping review framework.
No patient or public contribution.
Neonatal death and later disability remain common sequelae of hypoxic-ischaemic encephalopathy (HIE) despite the now standard use of therapeutic hypothermia (HT). New therapeutic approaches to brain protection are required. Melatonin is an indolamine hormone with free-radical scavenging, antiapoptotic, anti-inflammatory and gene regulatory neuroprotective properties, which has extensive preclinical evidence of safety and efficacy. Pharmacokinetic (PK) data suggest it is necessary to reach melatonin levels of 15–30 mg/L within 6–8 hours of hypoxia-ischaemia for brain protection. We developed a novel Good Manufacturing Practice (GMP) grade melatonin in ethanol 50 mg/mL solution for intravenous use. In preclinical studies, ethanol is an adjuvant excipient with additional neuroprotective benefit; optimised dosing protocols can achieve therapeutic melatonin levels while limiting blood alcohol concentrations (BACs).
The Acute High Dose Melatonin for Encephalopathy of the Newborn (ACUMEN) Study is a first-in-human, international, multicentre, phase 1 safety study of intravenous melatonin in babies with moderate/severe HIE receiving HT. Sixty babies will be studied over two phases: a dose escalation study including four dose levels to establish the recommended phase 2 dose (RP2D), followed by a 6-month cohort expansion study of RP2D to further characterise PKs and affirm safety. Participants will receive a 2-hour intravenous infusion of melatonin within 6 hours of birth, followed by five maintenance doses every 12 hours to cover the period of HT. Plasma melatonin and BACs will be monitored. The RP2D will be based on the attainment of therapeutic melatonin levels while limiting BACs and the frequency of dose-limiting events (DLEs). A Bayesian Escalation with Overdose Control approach will be used to estimate the risk of DLE per dose level, with a target level of
Approval has been given by the London Central National Health Service Health Research Authority Ethics Committee (25/LO/0170) and UK Clinical Trials Authorisation from the Medicines and Healthcare products Regulatory Agency. Separate approvals have been sought in Ireland and Australia. Dissemination will be via peer-reviewed journals, conference presentations, public registries and plain language summaries for parent/legal guardian(s), in accordance with national requirements.
ISRCTN61218504. EU CT: 2025-520538-49-00.
Publication based on the UK protocol V.3.0, 08 May 2025
We report the collaborative views of a group of nurses, midwives and allied health professionals (NMAHPs) in the UK who have a genomics research remit or interest. Our group includes genetic counsellors under this diverse category of healthcare workers.
This group came together as part of the National Institute for Health and Social Care Research (NIHR) Genomics Research National Specialty Group. After responding to a survey to elicit the views of NMAHPs working in genomics, some of the original 45 respondents, along with others who learnt of the project by word of mouth, have worked together to produce this article.
The paper aims to set out in clear terms the value of NMAHPs to research that supports the patient-centred implementation of genomics in the National Health Service (NHS).
We discuss four potential areas where NMAHPs, in particular, can contribute to the research. These are patient perspectives and epistemic justice, psychosocial impacts, the familial nature of genomics and equity. We argue that this group (NMAHPs) represents a potentially underused resource for the NHS as it seeks to ensure that advances in genomics are translated into patient benefit.
We propose that NMAHPs, with our research expertise, are well placed to shape and deliver a research agenda that explores models of patient-centred care in the genomics era. We call for increased funding for NMAHP research roles and funding opportunities to deliver this fundamental work.
To investigate what works when using Patient-Reported Outcome Measures (PROMs), for whom, in what contexts, and why in four Value-Based Healthcare (VBHC) programmes.
Realist evaluation.
Evaluation of Heart Failure, Parkinson's Disease, Epilepsy and Cataract surgery programmes using data from a scoping review, documentary analysis, questionnaires, quantitative routinely collected data and semi-structured interviews with staff, patients and carers (July 2022–August 2023). Programme theories and logic models were developed, tested and refined.
We conducted 105 interviews (67 patients, 21 carers and 17 staff) and collected data from 230 patients (66 Epilepsy, 140 Heart Failure and 24 Parkinson's Disease) and 14 staff via questionnaires. Clinicians used PROMs data to regularly monitor patients with Heart Failure and Epilepsy, which resulted in better triage and tailoring treatment, prioritisation of access based on the urgency of need, and facilitation of referral to relevant professionals. In Heart Failure, this further resulted in a more efficient provision of care and better use of resources, care closer to home, improved health outcomes (e.g., better symptom management) and service redesign. The same was not observed in Epilepsy, as patients who required mental health treatment had to be referred, but they were not always able to access specialist services. PROMs were discontinued in Cataract surgery services mainly due to the lack of integrated IT systems, which caused an increased workload and staff resistance. In Parkinson's Disease, patients were asked to complete PROMs even though the information was not consistently being used.
Findings challenge the orthodoxy that implementing PROMs is universally good and brings about real improvements in patient outcomes in a VBHC context. PROMs are generally ill-suited for long-term use with patients in routine care without further adaptation. Greater staff and patient involvement are imperative to enhance the acceptability and relevance of the programmes.
Patient-Reported Outcome Measures can improve care when embedded in well-supported systems. Implementation must be realistic, involve staff and patients, and be underpinned by clear leadership and robust digital infrastructure. Co-designed patient-facing tools can improve accessibility and engagement.
What problem did the study address? There is limited evidence on how Patient-Reported Outcome Measures function across different routine healthcare contexts. What were the main findings? Patient-Reported Outcome Measures improved care in Heart Failure but not in other services, largely due to contextual barriers. Where and on whom will the research have an impact? Findings are relevant for clinicians, service designers, and policymakers seeking to implement meaningful person-centred outcome measurement in long-term conditions.
We adhered to Realist and Meta-narrative Evidence Syntheses: Evolving Standards II guidance and to the Guidance for Reporting Involvement of Patients and the Public.
The study was developed alongside a wide range of patient and public stakeholders involved in the Aneurin Bevan University Health Board Value-Based Healthcare programme, third sector and specific individuals and groups representing the four included services (i.e., St. David's Hospice Care, British Heart Foundation, Digital Communities Wales, Epilepsy Action, Digital Communities Wales, Parkinson's UK Cymru, Race Equality First, Aneurin Bevan Community Health Council, Value- Based Healthcare Patient Reference Group and Wales Council of the Blind). A total of 10 virtual meetings were strategically planned to address gaps, assist in the interpretation of findings, and ensure that outcomes were pertinent and accessible to the specific needs and circumstances of under-represented or vulnerable groups.
People with a learning disability face significant health and mortality inequalities as well as wider systemic inequities. Challenges in palliative and end of life care (PEOLC) include communication difficulties, lack of involvement in decision-making and multimorbidity. Early identification of PEOLC needs is challenging, impacting timely care planning. The study aims to (1) understand barriers and enablers to providing high-quality, accessible PEOLC for people with a learning disability, and identify effective service delivery models and interventions and (2) improve PEOLC quality and accessibility by developing robust guidance for health and social care services.
This is a mixed-methods study guided by the NHS England 2021 Ambitions Framework and adopting the Social Model of Disability. There are four workstreams: (1) a retrospective cohort analysis of the Clinical Practice Research Datalink; (2) a rapid scoping review; (3) field work in four study sites across England, involving (a) interviews with senior leaders and commissioners (n=up to 16) and informal stakeholder engagement conversations; (b) ethnographic case studies with people with a learning disability at the end of life (n=up to 20) and retrospective case reviews of people with a learning disability who have died (n=up to 40), using family and staff interviews and (c) development and piloting of methods for enabling systematic identification of PEOLC need, using experience-based co-design and (4) patient and public involvement (PPI) activities and a co-production group of 10 people with a learning disability to support data analysis and outputs. Data will be analysed using adapted framework analysis methodology. This is an inclusive, co-produced study with significant involvement of advisors and researchers with a learning disability as part of the study team.
Ethical approval has been obtained for workstreams 1, 3a and 3b. Significant attention has been paid to ensuring informed consent, making adjustments for capacity. Accessible information and consent forms will be used, involving consultees and adhering to the Mental Capacity Act for participants who lack capacity. Data security will follow General Data Protection Regulation rules. Dissemination will include patient exemplars, guidance and various resources, engaging stakeholders through multiple formats.
researchregistry10500.
SARS-CoV-2 infection provides protection against reinfection and severe COVID-19 disease; however, this protective effect may diminish over time. We assessed waning of natural immunity conferred by previous infection against severe disease and symptomatic reinfection in Brazil and Scotland.
We undertook a test-negative design study and nested case–control analysis to estimate waning of natural immunity against severe COVID-19 outcomes and symptomatic reinfection using national linked datasets. We used logistic regression to estimate ORs with 95% CIs. A stratified analysis assessed immunity during the Omicron dominant period in Brazil.
We included data from the adult populations of Brazil and Scotland from 1 June 2020 to 30 April 2022.
Severe COVID-19 was defined as hospitalisation or death. Reinfection was defined as reverse-transcriptase PCR or rapid antigen test confirmed at least 120 days after primary infection.
From Brazil, we included 30 881 873 tests and 1 301 665 severe COVID-19 outcomes, and from Scotland, we included 1 520 201 tests and 7988 severe COVID-19 outcomes. Against severe outcomes, sustained protection was observed for at least 12 months after primary SARS-CoV-2 infection with little evidence of waning: 12 months postprimary infection: Brazil OR 0.12 (95% CI 0.10 to 0.14), Scotland OR 0.03 (95% CI 0.02 to 0.04). For symptomatic reinfection, Brazilian data demonstrated evidence of waning in the 12 months following primary infection, although some residual protection remained beyond 12 months: 12 months postprimary infection: OR 0.42 (95% CI 0.40 to 0.43). The greatest reduction in risk of SARS-CoV-2 infection was in individuals with hybrid immunity (history of previous infection and vaccination), with sustained protection against severe outcomes at 12 months postprimary infection. During the Omicron dominant period in Brazil, odds of symptomatic reinfection were higher and increased more quickly over time when compared with the overall study period, although protection against severe outcomes was sustained at 12 months postprimary infection (whole study: OR 0.12 (95% CI 0.10 to 0.14); Omicron phase: OR 0.15 (95% CI 0.12 to 0.19)).
Cross-national analyses demonstrate sustained protection against severe COVID-19 disease for at least 12 months following natural SARS-CoV-2 infection, with vaccination further enhancing protection. Protection against symptomatic reinfection was lower with evidence of waning, but there remained a protective effect beyond 12 months from primary infection.
Guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF) reduces morbidity and mortality and remains widely underused. An HFrEF polypill containing all four pillars of GDMT has been proposed as an implementation strategy to improve GDMT treatment rates and subsequent patient outcomes. We present the design and protocol for a proof-of-concept, pilot type I hybrid randomised clinical trial evaluating an HFrEF polypill compared with usual care among patients with HFrEF in Sri Lanka to evaluate short-term feasibility.
This multi-centre, open-label, pilot type I hybrid randomised clinical trial will recruit 40 adults with HFrEF from two public hospital sites in Colombo, Sri Lanka. Participants will be randomised to an HFrEF polypill (containing bisoprolol, losartan, eplerenone, and dapagliflozin in three available strengths) or usual care and followed for 4 weeks. The primary outcome is feasibility of recruitment measured by recruitment rate and adherence to study protocols measured by completion rate of study-related procedures. Other key outcomes include adherence to GDMT and assessment of serious adverse events among other exploratory outcomes.
The study has been approved by the ethics review committee at the Faculty of Medicine, University of Kelaniya (Sri Lanka), the institutional review board at Washington University in St. Louis (United States), and the National Medicines Regulatory Authority (Sri Lanka). The findings of this pilot trial will inform the design and implementation of a future large-scale type I hybrid trial to assess the efficacy and safety of an HFrEF polypill in improving clinical outcomes.
Sri Lanka Clinical Trials Registry (SLCTR/2024/003); ClinicalTrials Registry (NCT06831864).
Fathers are intricately bound to the experience of adolescent mothers and their children. Yet, fathers of children born to adolescent mothers, particularly within the context of HIV, remain neglected in the literature. These exploratory analyses provide insight into the characteristics of fathers of children born to adolescent mothers affected by HIV in South Africa.
Eastern Cape Province, South Africa.
Cross-sectional data from a prospective cohort study.
Young mothers (10–24 years of age) and their children (0–68 months). All mothers completed detailed study questionnaires, including standardised and study-specific measures, relating to their self, their children and the fathers of their children. Summary statistics are presented based on maternal self-report of father characteristics. 2 tests and t-tests (Fisher’s exact/Kruskal-Wallis tests, where appropriate) were additionally used to explore sample characteristics (including father characteristics, maternal experience and child characteristics) according to paternal age and father involvement in childcare (defined by responses to four maternal self-report questions). Father characteristics were also explored according to maternal HIV status and maternal mental health status.
40% of fathers were adolescents (10–19 years) at the birth of their children. Overall, father involvement was low (19.5%). Compared with noninvolved fathers, involved fathers were more likely to be older when their child was born (21 years vs 20 years, t=4.30, p=0.04), to be in a relationship with the mothers of their children (74.8% vs 47.2%, 2=40.8, p≤0.0001), to reside with their children and their mothers (14.7% vs 3.7%, 2=49.3, p≤0.0001) and to attend the first antenatal appointment (4.3% vs 1.5%, 2=5.21, p=0.02). A quarter (25.4%; 227/894) of the adolescent mothers in the sample were living with HIV. The prevalence of maternal HIV was found to be higher among adolescent mothers of children born to older fathers compared with adolescent fathers (31.7% vs 15.9%, 2=28.3, p≤0.001). Likewise, depressive symptoms were more prevalent among adolescent mothers of children born to older fathers compared with adolescent fathers (9.9% vs 5.3%, 2=6.08, p=0.01). Adolescent mothers reporting poor mental health were less likely to be in a relationship with the fathers of their children (41.8% vs 54.1%, 2=7.32, p=0.03) and more likely to experience domestic violence perpetrated by the fathers of their children (8.2% vs 3.3%, 2=6.07, p=0.01) and to engage in arguments about finances with the fathers of their children (30.0% vs 17.0%, 2=10.8, p=0.001). While some differences in individual subscales were identified, overall composite scores of child cognitive development did not differ according to father age or father involvement.
Analyses provide the first preliminary description of the fathers of children born to adolescent mothers affected by HIV in South Africa. Fathers are inherently tied to the experiences of adolescent mothers and their children. Father involvement with their children was low. Further research is required to explore the potential barriers to father involvement and pathways to overcome these. Efforts to bolster father engagement, such as the inclusion of fathers within maternal and child service provision, may have benefits for fathers, adolescent mothers and their children. There was a high prevalence of adolescent fatherhood in the study. Adolescent fathers may have specific needs requiring tailored intervention for adolescent parent families. The need for the inclusion of fathers within policy, programming and research remains.
The aim of this scoping review was to map the literature pertaining to the use of eHealth interventions to prevent pressure injuries in populations at risk of the complication, and describe the interventions encountered with the help of Greenhalgh et al.'s Nonadoption, Abandonment, Scale-up, Spread and Sustainability framework. Articles were retrieved using database queries to CINAHL, Medline, ScienceDirect and the Cochrane library with a search string strategy that considered articles from the inception of each database until the 29th of January 2024. The interventions from the 27 included studies were then evaluated using the Nonadoption, Abandonment, Scale-up, Spread and Sustainability framework. The included studies had a publication date range from 1997 to 2023 and included diverse study designs encompassing experimental trials, qualitative designs, mixed-methods, cohort studies and randomised control trials (including secondary analyses). There was a preference for app-based interventions (15/27) that are installed on smartphones, while other interventions encompassed a bed with sensors that automatically adjusted air cell pressure, clinical support algorithms and continuous sensing devices. In conclusion, this scoping review provides an overview of the various technological solutions currently available for pressure injury prevention as well as recommendations for improving the long-term adoption of future eHealth interventions.
To determine if carer administration of as-needed subcutaneous medication for common breakthrough symptoms in people dying at home is feasible and acceptable in the UK, and if it would be feasible to test this intervention in a future definitive randomised controlled trial.
We conducted a two-arm, parallel-group, individually randomised, open pilot trial of the intervention versus usual care, with a 1:1 allocation ratio, using convergent mixed methods.
Home-based care without 24/7 paid care provision, in three UK sites.
Participants were dyads of adult patients and carers: patients in the last weeks of their life who wished to die at home and lay carers who were willing to be trained to give subcutaneous medication. Strict risk assessment criteria needed to be met before the approach, including a known history of substance abuse or carer ability to be trained to competency.
Intervention-group carers received training by local nurses using a manualised training package.
Quantitative data were collected at baseline and 6–8 weeks post-bereavement and via carer diaries. Interviews with carers and healthcare professionals explored attitudes to, experiences of and preferences for giving subcutaneous medication and experience of trial processes. The main outcomes of interest were feasibility, acceptability, recruitment rates, attrition and selection of the most appropriate outcome measures.
The secondary outcome measure was time to symptom relief, calculated using data items from the carer diary, after the patient had died.
In total, 40 out of 101 eligible dyads were recruited (39.6%), which met the feasibility criterion of recruiting >30% of eligible dyads. The expected recruitment target (50 dyads) was not reached, as fewer than expected participants were identified. Although the overall retention rate was 55% (22/40), this was substantially unbalanced (30% (6/20) usual care and 80% (16/20) intervention). The feasibility criterion of >40% retention was, therefore, considered not met. A total of 12 carers (intervention, n=10; usual care, n=2) and 20 healthcare professionals were interviewed. The intervention was considered acceptable, feasible and safe in the small study population. The intervention group had a considerably shorter time to medication administration than the usual-care group (median time to administer medication in intervention=5 min, usual-care=105 min). Intervention group carers felt confident in administering medication. Healthcare professional support was sought by intervention group carers in 24 out of 147 (16.3%) medication administration entries. The context of the feasibility study was not ideal, as district nurses were overstretched, unfamiliar with research methods and possibly not in equipoise. A disparity in readiness to consider the intervention was demonstrated between carers, who were uniformly enthusiastic, and healthcare professionals who were not. Findings confirmed methodological and ethics issues pertaining to researching the last days of life care.
The success of a future definitive trial is uncertain because of equivocal results in the progression criteria, particularly poor recruitment overall and a low retention rate in the usual-care group. Future work regarding the intervention should include understanding the context of UK areas where this has been adopted, ascertaining wider public views and exploring healthcare professional views on burden and risk in the NHS context. There should be consideration of the need for national policy and the most appropriate quantitative outcome measures to use. This will help to ascertain if there are unanswered questions to be studied in a trial.
Ensuring equity in clinical trials has been declared a global priority. Australia is competitive in the international clinical trial sphere. We aimed to explore factors that influence oncology clinical trial participation in Australia.
Scoping review.
On 27 May 2024, a systematic search using a predefined strategy was conducted across four electronic databases (Medline, CINAHL, EMBASE and Scopus), grey literature and hand searches.
All cancer (haematological and non-haematological) clinical trials that discussed factors influencing participation in Australia were included. There were no language or age restrictions.
Data were extracted using a predesigned extraction tool. Quantitative results were analysed using descriptive statistics. Qualitative data were synthesised using a framework method into four domains (1) patients, (2) healthcare professionals, (3) clinical trials and (4) health services.
Of 1084 citations identified, 393 duplicates were removed. Of the 691 titles and abstracts screened, 54 articles underwent full-text review, and 42 articles were included in the final analysis. Key factors that influence clinical trial participation were identified across all domains, many consistent with the international literature. For example, while self-reported willingness emerged as a key facilitator across diverse patient groups, cohort studies revealed lower participation rates for migrant populations, older patients and those residing in regional areas. Importantly, we were also able to identify the foundations of an evidence base of interventions that directly support increased clinical trial participation.
This scoping review contributes new findings to a body of international literature, while contributing a unique Australian perspective. These findings establish the foundations of an evidence base that supports inclusive clinical trial participation.
The aim of this study was to determine the feasibility of delivering personalised isometric exercise (IE) for people with stage 1 hypertension. Is it feasible to deliver an isometric wall squat intervention in the National Health Service and what sample size is required to conduct an appropriately powered effectiveness randomised controlled trial (RCT)?
Randomised controlled open-label multicentre feasibility study of IE compared with standard care in unmedicated people with stage 1 hypertension.
Initially, the study aimed to recruit through primary care, but this process coincided with the advent of the COVID-19 pandemic. Therefore, we shifted focus to direct-to-public advertising and delivery in secondary care.
People with unmedicated stage 1 hypertension aged over 18 able to perform IE were included. Patients were excluded if average home systolic blood pressure (sBP)
Intervention participants were randomised (1:1) to either standard lifestyle advice or an individualised isometric wall squat prescription, performed 4x2-min bouts three times a week for 6 months.
We assessed deliverability, attrition, adherence and variance in blood pressure (BP) change.
IE was found to be easily deliverable to all participants. At 6 months, 34% had withdrawn. Of those who completed IE, 85% of their sessions were at the correct intensity, meeting our retention criterion for success. Variance in BP change was 14.4 mm Hg. The study was not powered to show a difference in BP between groups; however, BP reductions were seen in the intervention group at all study time points compared with baseline. There were no adverse events related to study participation.
We met our a priori recruitment criteria which allowed us to calculate a sample size (n=542) for a full RCT. The results demonstrate good acceptability and adherence rates to the treatment protocol. Our results show a signal towards a consistent sBP reduction in the IE group compared with baseline.
NCT04936022 (
To examine factors influencing health-seeking behaviours and self-care practices of diabetes, including the uptake and use of diabetic services among community-dwelling black African-Caribbean people living in the UK.
Cross-sectional/qualitative.
Community (Southwestern England).
Nineteen individuals of African-Caribbean heritage, over the age of 50 years, diagnosed with type 2 diabetes.
Three focus group discussions (FGDs), each of which lasted for approximately 90 min, were held. These interviews were facilitated by a community-based health champion and a researcher of African-Caribbean heritage. Audio recordings were transcribed verbatim, coded in NVivo software, and analysed using an inductive thematic approach.
FGD data.
A total of nine culturally specific and non-specific (generic) themes were identified. Culturally specific themes included the normalisation of diabetes at the community level, which was more pronounced among men than women. Participants were found to be inclined to either substitute or complement diabetes medications with cultural herbal remedies. There was a lack of trust in medical centric advice received from healthcare practitioners. Participants also expressed that healthcare practitioners do not always listen to or understand their needs and reported that there was a lack of culturally appropriate diabetes education and training programmes for their community members. Generic themes included difficulties and frustrations in getting doctor’s appointments, self-indiscipline and poor motivation for engaging in physical exercise and healthy eating.
Several cultural/community-related factors influence health-seeking behaviours and self-care practices of diabetes in African-Caribbean people living in the UK, often affecting men and women differently, alongside more general individual and healthcare system-related barriers. Addressing these factors is imperative in designing a culturally and demographically tailored diabetes education programme for these people.
This article aimed to explore patients’ experiences of attending the emergency department (ED) for low back pain (LBP) and provides a theoretically informed analysis of the ED cultures perceived by patients to inform their experiences of care.
Multisite, cross-sectional qualitative interview study.
Four NHS Emergency Departments located in the UK.
47 adults (aged 23–79 years) who, in the past 6 weeks, had attended the ED for LBP (all types and durations). Purposive sampling was used to gain variation in the recruiting sites, and participants’ LBP and demographic characteristics.
Data were collected using individual, semistructured, telephone interviews (median 45 min duration) which were audio-recorded and transcribed verbatim. Analysis was informed using reflexive thematic analysis and ideal type analysis. Cycles of inductive and deductive analysis were undertaken, with Bourdieu’s concepts of field and habitus employed to help explain the findings.
We present three contrasting cultures of ED care for LBP, comprising (1) emergency screening only, (2) ‘cynicism and neglect’ and (3) appropriate and kind care. Taking each culture (field) in turn, we explore important differences in the content and delivery of care. Drawing on Bourdieu’s concepts of field and habitus, we consider the social and institutional norms and misrepresentations likely to underpin the thoughts and behaviours of ED staff (their habitus), and why these tended to vary based on where and by whom the patient was managed in the ED.
Strategies to improve patients’ experience need to review the social and institutional norms that underpin staff habitus, the assumptions informing these norms and the voices that validate and reproduce them.
There have been previous initiatives to identify key performance indicators (KPIs) for continuous kidney replacement therapy. However, no formal reviews of the evidence for KPIs of intermittent kidney replacement therapy (IKRT) have been conducted. This systematic review will appraise the evidence for KPIs of IKRT in critically ill patients and is part of the DIALYZING WISELY (NCT05186636) programme which aims to improve the performance of acute renal replacement therapy in intensive care units by aligning local practices with evidence-based best practices.
Ovid MEDLINE, Ovid Embase, CINAHL and Cochrane Library will be searched for studies involving KPIs for IKRT. Grey literature will also be searched and include technical reports, practice guidelines and conference proceedings as well as websites of relevant organisations. We will search the Agency of Healthcare Research and National Quality Measures Clearinghouse for IKRT-related KPIs. Studies will be included if they contain KPIs, occur in critically ill patients and are associated with IKRT. We will evaluate the risk of bias using the modified Cochrane tool and certainty of evidence using the Grading of Recommendations, Assessment, Development and Evaluations methodology. The analysis will be primarily descriptive. Each KPI will be evaluated for importance, scientific acceptability, usability and feasibility using the four criteria proposed by the United States Strategic Framework Board for a National Quality Measurement and Reporting System. Finally, KPIs will be appraised for potential operational characteristics, potential to be integrated into electronic medical records, adoptability by stakeholders and affordability, if applicable.
Ethics approval is not required as primary data will not be collected. Findings of this review will be disseminated through peer-related publication.
CRD42022074444.
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