Conectar
Primary biliary cholangitis (PBC) is a rare chronic cholestatic disease that despite current therapy has significant ongoing unmet needs, including risks of cirrhosis and life-impairing symptoms. The current treatment approach is a step-up model, wherein first-line therapy, ursodeoxycholic acid (UDCA), is given for a minimum of 12 months before the addition of second-line therapy is considered for non-responding patients. This ‘waiting to fail’ approach, focused on the needs of low-risk patients, allows, we postulate, a key process of biliary epithelial cell (BEC) senescence to become established, driving accelerated bile duct loss and aggressive disease. Preclinical mouse modelling has shown that early use of the farnesoid X receptor agonist obeticholic acid (OCA), currently only used as second-line therapy following UDCA failure, reverses BEC senescence, changing the clinical course of disease. Here, we describe the design of the Optimising Primary thErapy in pRimAry biliary cholangitis (OPERA) trial. The aim of OPERA is to explore a new paradigm for disease-modifying treatment of PBC: risk-informed early treatment stratification, with patients at increased risk offered UDCA and OCA combination with the goal of complete biochemical remission.
OPERA is a multicentre, randomised, double-blind, placebo-controlled trial of OCA in combination with UDCA, as first-line treatment for high-risk PBC. This is a multicentre trial in England, which will be undertaken in specialist clinics in secondary/tertiary referral centres (or as per local set up). These centres will be specialists in the area of PBC management and will manage patients from across their local region. OPERA will recruit and randomise 106 adults, within 6 months of PBC diagnosis, who are at an enhanced risk of non-response to standard first-line therapy, between either: (1) UDCA and OCA or (2) UDCA and matched placebo in a 1:1 ratio. The primary efficacy outcome measure is the percentage of participants showing normalisation of serum alkaline phosphatase and total bilirubin values at 26 weeks (disease remission).
Favourable ethical opinion was received from London – Riverside Research Ethics Committee (reference: 22/LO/0878). Potential participants will be fully informed of their rights and the benefits and harms of the trial by the research team before giving informed consent to participate in the trial. Results will be disseminated in peer-reviewed publications, at national and international conferences, in peer-reviewed journals and to participants and the public (using lay language).
To explore community nurses' experiences of changes to their roles in palliative and end-of-life care.
An e-survey was followed by focus groups.
Fifty-one community nurses with recent experience of delivering end-of-life care in the United Kingdom completed a survey about changes to their roles. A purposive sample of 35 respondents participated in focus groups exploring these changes in more depth; thematic analysis was used with constant comparison.
As well as two new roles—prescribing and verifying death—many participants talked about a broader expansion of their role, increasing their leadership in making complex end-of-life care decisions with patients and families. Most nurses expressed pride in their new knowledge and skills, and satisfaction with the care they were providing. Yet many also expressed distress that heavy workloads impaired their capacity both to provide good clinical care and to train junior colleagues. The importance of General Practitioner support with complex cases was often highlighted, but accessing such support was sometimes difficult.
While welcoming the opportunity to extend their palliative care roles, many participants indicated experiencing moral distress.
Excessive workloads and patchy medical support threaten the retention of the experienced nurses upon whom community palliative care depends.
Our findings suggest that new and extended palliative care roles are viewed positively by nurses. To be sustainable, these changes require better workload management and consistent medical back-up.
We adhered to relevant EQUATOR guidelines, using the SRQR checklist.
Our Public and Clinician Advisory Group helped shape questions and commented on findings.
In 2023, 21% of deaths occurred in residential aged care facilities (RACFs), a setting expected to play an increasing role in palliative and end-of-life care (PEoLC). General practitioners (GPs) oversee and deliver PEoLC in residential and nursing homes, yet little is known about their practice. We conducted a systematic review of the published evidence concerning how GPs provide this care: what they do and the quality, challenges and facilitators of that care.
Systematic review and narrative synthesis using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses.
Medline, Embase, CINAHL, PsycINFO, Web of Science, Scopus and NHS Evidence and grey literature via Google Scholar were searched through 9 October 2024.
We included studies presenting new empirical data from qualitative, quantitative or mixed methods, were published in the English language and conducted in the UK, the European Union, Australia, New Zealand and Canada. We excluded studies with no new empirical data, discussion papers, conference abstracts, opinion pieces, study participants under 18 years old and in care settings other than RACF.
One independent reviewer used standardised methods to search and screen study titles for inclusion. This reviewer assessed all abstracts of the included papers, and a second independent reviewer screened 60% of the abstracts to validate inclusion. Risk of bias was assessed using Gough’s Weight of Evidence assessment. Thematic analysis was used to describe the contents of the included papers; a narrative synthesis approach was taken to report the findings at a more conceptual level.
The search identified 5936 titles: 35 papers were eligible and included in the synthesis. This is a nascent evidence base, lacking robust research designs and characterised by small sample sizes; the results describe the factors observed to be important in the delivery of care. Care provision is extremely variable; no models of optimal care have been put forward or tested. Challenges to care provision occur at every level of the care system. At macro level, service-level agreements and policies vary: at meso level, team-working, communication technology solutions and equipment availability vary: at micro level, GPs’ interests in providing PEoLC vary as does their training. No study addresses residents’ and relatives’ experiences and expectations of GPs' involvement in PEoLC in RACFs.
The limited evidence base highlights that GP care at end of life for RACF residents varies greatly, with enablers and challenges at all levels in the existing care systems. Little research has examined GP PEoLC for RACF residents in its own right; insight is derived from studies that report on this issue as an adjunct to the main focus. With national policies focused on moving more PEoLC into community settings, these knowledge deficits require urgent attention.
While group, task-oriented, community-based exercise programs (CBEPs) delivered in-person can increase exercise and social participation in people with mobility limitations, challenges with transportation, cost and human resources, threaten sustainability. A virtual delivery model may help overcome challenges with accessing and delivering in-person CBEPs. The study objective is to estimate the short-term effect of an 8-week, virtual, group, task-oriented CBEP called TIME™ (Together in Movement and Exercise) at Home compared with a waitlist control on improving everyday function in community-dwelling adults with mobility limitations.
A randomised controlled trial incorporating a type 1 effectiveness-implementation hybrid design is being conducted in four Canadian metropolitan centres. We aim to stratify 200 adults with self-reported mobility limitations by site, participation alone or with a partner, and functional mobility level, and randomise them using REDCap software to either TIME™ at Home or a waitlist control group. During TIME™ at Home classes (2 classes/week, 1.5 hours/class), two trained facilitators stream a 1-hour exercise video and facilitate social interaction prevideo and postvideo using Zoom. A registered healthcare professional at each site completes three e-visits to monitor and support implementation. Masked evaluators with physical therapy training evaluate participants and their caregivers at 0, 2 and 5 months using Zoom. The primary outcome is the change in everyday function from 0 to 2 months, measured using the physical scale of the Subjective Index of Physical and Social Outcome. The study is powered to detect an effect size of 0.4, given α=0.05, power=80% and a 15% attrition rate. Secondary outcomes are mobility, well-being, reliance on walking aids, caregiver assistance, caregiver mood, caregiver confidence in care-recipient balance and cost-effectiveness. A multimethod process evaluation is proposed to increase understanding of implementation fidelity, mechanisms of effect and contextual factors influencing the complex intervention. Qualitative data collection immediately postintervention involves interviewing approximately 16 participants and 4 caregivers from the experimental group, and 8 participants and 4 caregivers from the waitlist control group, and all healthcare professionals, and conducting focus groups with all facilitators to explore experiences during the intervention period. A directed content analysis will be undertaken to help explain the quantitative results.
TIME™ at Home has received ethics approval at all sites. Participants provide verbal informed consent. A data safety monitoring board is monitoring adverse events. We will disseminate findings through lay summaries, conference presentations, reports and journal articles.
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