Conectar
Immune checkpoint inhibitors (ICIs) have revolutionised cancer treatment through targeted disruption of the physiological pathways that maintain tissue tolerance, but which are co-opted by cancers to evade immunosurveillance. Thus, the resultant T-cell activity often causes immune-related adverse events including immune checkpoint inhibitor-induced inflammatory arthritis (ICI-IA). ICI-IA results in functional impairment that frequently persists, even after ICI discontinuation, with substantial quality-of-life impacts for cancer survivors.
A high-quality body of evidence to guide ICI-IA management remains an unmet need. Pharmacological treatment may be prolonged, typically begins with non-specific immunosuppression, including systemic steroids, and is usually only rationalised to more targeted therapy in resistant cases. Moreover, retrospective data suggest the high dose glucocorticoids sometimes used in new-onset ICI-IA may be associated with worse cancer outcomes.
Tumour necrosis factor (TNF) inhibition strategies are well established with excellent efficacy and safety profiles in ‘spontaneous’ inflammatory arthritides including rheumatoid and psoriatic arthritis. Mechanistic evidence from ex vivo and murine studies also supports the utility of anti-TNF therapy for steroid-refractory cases of ICI-IA. Although good clinical responses have been reported in this setting, the REACT trial (REmission induction of Arthritis caused by Cancer ImmunoTherapy) aims to provide randomised and robust clinical evidence for deploying targeted therapy earlier in ICI-IA management. It will test whether up-front anti-TNF therapy can more effectively and quickly control symptoms, reduce glucocorticoid exposure, prevent early ICI discontinuation and increase the frequency of drug-free ICI-IA remission.
REACT is a prospective, multicentre, open-label, superiority, two-arm, randomised controlled clinical trial to guide initial therapy for patients with ICI-IA. The trial will compare the current standard of care (initial prednisolone; Arm A) with the anti-TNF drug, adalimumab without glucocorticoids (Arm B).
The primary outcome is glucocorticoid-free arthritis remission rate at 24 weeks where remission is defined as: (i) No use of systemic or intra-articular glucocorticoids (except when used for adrenal insufficiency) within 4 weeks prior to assessment at 24 weeks; and (ii) absence of synovitis on clinical examination.
The protocol was approved by East Midlands—Leicester South Research Ethics Committee on 31-Oct-2024 (Ref: 24/EM/0202). Participants are required to provide written informed consent. The results of this trial will be disseminated through national and international presentations and peer-reviewed publications.
Falls are a significant health concern and associated with cancer survivorship. Falls can result in negative psychosocial consequences for cancer survivors and economic sequelae for healthcare delivery. There are cancer-specific fall risk factors relevant to cancer survivors which can contribute to increased fall risk. However, fall prevention may not be addressed in standard care for cancer survivors. This review aims to synthesise the findings from published research to explore the intervention characteristics and the effectiveness of fall prevention interventions on the incidence of falls and risk factors for falls in cancer survivors.
This systematic review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A systematic search in CINAHL Ultimate, PubMed, Scopus, Embase and supplementary search Google Scholar will be conducted in November 2025. We will include randomised controlled and controlled trials that describe the characteristics of the programme and report falls or risk factors for falls as outcomes. Title, abstract and full-text screening will be performed independently by two reviewers. The Tool for the assEssment of Study qualiTy and reporting in EXercise (TESTEX), Risk Of Bias instrument for Use in SysTematic reviews-for Randomised Controlled Trials (ROBUST-RCT) and Grading of Recommendations Assessment, Development and Evaluations (GRADE) tools will be used to assess the quality and certainty of evidence. We will provide a summary of the intervention characteristics and perform a meta-analysis or narrative synthesis of the findings as appropriate.
Ethics approval is not required for this systematic review as we will include papers published in peer-reviewed journals and original data will not be collected. The findings of this systematic review will be disseminated in a peer-reviewed publication and presented at relevant conferences.
ID 1240723.
To test the feasibility and acceptability of a newly developed model of neonatal nurse-controlled analgesia to manage pain in the post-operative infant.
The study utilised a single-centre two-arm parallel, unblinded randomised controlled external pilot trial design.
The pilot trial was conducted in a surgical neonatal tertiary intensive care unit in Brisbane, Australia. Eligible infants were randomised to receive either post-operative pain management care via a model of neonatal nurse-controlled analgesia or standard care. Feasibility and acceptability were the primary outcomes. Seven feasibility outcomes were assessed by a traffic light system to delineate progression to a larger trial. Acceptability and clinical utility of the model of care by staff were assessed by feedback from an anonymous questionnaire that was administered at the completion of the trial period. Secondary outcomes included parental attitudes and perceptions of post-operative pain management to help establish primary outcomes for a larger randomised controlled trial.
Overall staff found the formalised model beneficial for managing post-operative pain but found the complexity of the model and ability to titrate analgesia based only on documented pain scores barriers requiring further consideration. Three of the seven feasibility outcomes failed to reach ‘greenlight’ targets to progress to a larger trial with adherence to the model, and the proportion of eligible infants not recruited was allocated a ‘redlight’. Secondary outcomes were comparable and support future study.
This pilot feasibility study has shown that a model of neonatal nurse-controlled analgesia can be safely implemented and utilised in the post-operative care of the surgical neonate. Further exploration of the barriers to model adherence and recruitment is warranted before a future larger trial is undertaken.
Though not all primary outcomes reached an acceptable range for further progression, this pilot feasibility study provided invaluable learning and has provided direction for future research into the provision of a family integrated and responsive model of analgesia.
This study is reported in line with the Consolidated Standards of Reporting Trials (CONSORT): Extension to randomised pilot and feasibility trial and the TIDieR Checklist (Template for Intervention, Description and Replication).
No patient or public contribution was utilised for this study.
Trial Registration: ACTRN12623000643673—the trial was prospectively registered
by Patricia Quintero-Rincón, Karina Caballero-Gallardo, Elkin Galeano, Oscar Flórez-Acosta
This study investigated the chemical and biological potential of Bidens pilosa and Croton sp., plants from megadiverse ecosystems in Colombia, collected in Santander de Quilichao (Cauca) and San Basilio de Palenque (Bolivar). The chemical profile was analyzed by UHPLC-ESI-Orbitrap-HRMS, and the total phenolic and flavonoid content was quantified using colorimetric methods. Antioxidant capacity was assessed using methods that evaluate reducing power and electron transfer mechanisms. The inhibition of key enzymes in skin aging, such as tyrosinase, hyaluronidase, and collagenase, was evaluated, as well as cytotoxicity in keratinocytes and human melanoma cells. Chemical characterization revealed distinctive phytochemical profiles: B. pilosa contained 21.1 mg GAE/g DT of phenolics and 64.6 mg RE/g DT of flavonoids, dominated by p-coumaric acid and rosmarinic acid, while Croton sp. exhibited higher levels of phenolics (169.4 mg GAE/g DT) and 54.1 mg RE/g DT of flavonoids, highlighting rosmarinic acid, p-coumaric acid and quercetin. Both extracts showed significant antioxidant capacity and enzyme modulation, including moderate collagenase inhibition (53.9–55.0%), high hyaluronidase inhibition (64.5–76.5%), and low tyrosinase inhibition (11.1–12.7%), suggesting protection of extracellular matrix and hyaluronic acid during skin aging. Sun protection factor was limited (SPF: 14.5 for B. pilosa and 11.6 for Croton sp.), with low ultraviolet absorption, consistent with low antityrosinase activity. Cytotoxicity assays demonstrated that B. pilosa was not toxic to HaCaT keratinocytes (IC₅₀ > 500 µg/mL) and displayed antimelanoma activity on A375 cells (IC₅₀ = 398.6 µg/mL), whereas Croton sp. showed moderate selectivity towards melanoma cells (IC₅₀ HaCaT = 329.5 µg/mL; IC₅₀ A375 = 189.0 µg/mL). The results suggest that both plants have potential in dermatological applications such as anti-melanoma agents, antioxidants, and modulators of skin aging enzymes, although highlight the importance of improving strategies to maximize their efficacy and safety.This project explores the feasibility of setting up a neuropsychiatric de-identified database (DiD) and a Research Register (RR) to collect, analyse, monitor and systematically report clinical data for people with intellectual disabilities (PwIDs) and epilepsy.
A multicentre project designed to collect de-identified data from clinical records at three adult ID specialist services in England and Wales and to develop an RR of PwID and epilepsy. Patients added to the DiD will be identified from patient clinic lists, clinic letters, in-house databases and electronic systems. Patients to be added to the RR will also be identified through attendance for regular review at clinic appointments. The collected data will be entered into the Research Electronic Data Capture (REDCap) database. Personal details of PwID and their consultees will also be collected from participants who consent to be on the RR. Around 600 PwID and epilepsy (200 per site) will be added to the DiD at the three sites, while around 45–60 participants (15–20 per site) are anticipated to be added to the RR. Data analysis will involve using descriptive statistics to summarise feasibility outcomes, such as screening and recruitment rates, as well as the completeness of the collected data. The characteristics of the participants (demographic, ID classification, clinical, epilepsy history and antiseizure medication) will be summarised descriptively. Progression will be assessed using the Red/Amber/Green stop-go criteria to determine if a national register should be created.
Ethical approval (24/NW/0210) has been obtained from the Northwest-Haydock Research Ethics Committee and the University of Plymouth Faculty Research Ethics and Integrity Committee (reference no. 5284). The project is funded by Jazz Pharmaceuticals as an independent investigator-initiated support grant and, as such, has received independent peer review.
Informal caregivers play a vital role in caring for individuals who choose to spend the end of their life at home. However, this caregiving role often imposes considerable physical, emotional, social and financial burdens that can negatively impact caregivers’ quality of life. A comprehensive understanding of the breadth of interventions designed to support caregivers of individuals receiving home-based palliative and end-of-life care is essential, along with insights into how these interventions are perceived by those who have received them. The objective of this review is to synthesise existing evidence on the effectiveness and appropriateness of interventions that support informal caregivers of patients receiving home-based palliative care in order to address the caregivers’ needs and improve their quality of life. Additionally, this review aims to explore the acceptability and perceived benefits of these interventions from the perspectives of informal caregivers who have received them.
A comprehensive search will be performed in the following databases: MEDLINE (PubMed), CINAHL, PsycINFO, Web of Science, Scopus, Cairn.info, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL). This review will include studies that focus on adult informal caregivers of adult patients with serious life-threatening illnesses receiving home-based palliative care. Interventional studies that employed quantitative, qualitative and mixed-methods approaches will be considered. Quantitative studies will include randomised controlled trials (RCTs) and experimental and quasi-experimental designs. Qualitative studies will encompass research that explores informal caregivers’ experiences with the interventions, perceived benefits and barriers and enablers influencing intervention effectiveness. Mixed-methods studies using convergent, embedded or sequential designs will also be included.
The search will include studies published in English or French, with no restrictions on the publication period. Study selection, critical appraisal and data extraction will be conducted independently by two reviewers to ensure methodological rigour. This review will adhere to the Joanna Briggs Institute guidelines for mixed-methods systematic reviews, using a convergent segregated approach. Findings will be reported in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines.
Ethical review is not required for this study, as it is a literature review that does not involve the collection of primary data. The findings of this review will be disseminated to the scientific community through conference presentations and peer-reviewed publications. Additionally, lay summaries will be prepared and shared with the general public and relevant stakeholders.
PROSPERO, registration number CRD420251006612.
While digital technologies can increase the availability and access to evidence-based interventions, little is known about how users engage with them and the mechanisms associated with effective outcomes. Process evaluations are an important component in understanding the aforementioned factors. The ‘SPARX-UK’ study is a randomised controlled pilot and feasibility trial evaluating personalised human-supported (from an ‘eCoach’) vs a self-directed computerised cognitive behavioural therapy intervention (cCBT), called SPARX (Smart, Positive, Active, Realistic, X-factor thoughts), aimed at adolescents with mild to moderate depression. We are comparing supported vs self-directed delivery of SPARX to establish which format should be used in a proposed definitive trial of SPARX. The control is a waitlist group. We will conduct a process evaluation alongside the trial to determine how the intervention is implemented and provide context for interpreting the feasibility trial outcomes. We will also look at the acceptability of SPARX and how users engage with the intervention. This protocol paper describes the rationale, aims and methodology of the SPARX-UK trial process evaluation.
The process evaluation will use a mixed-methods design following the UK Medical Research Council’s 2015 guidelines, comprising quantitative and qualitative data collection. This will include analysing data usage of participants in the intervention arms; purposively sampled, semi-structured interviews of adolescents, parents/guardians, eCoaches and clinicians/practitioners from the SPARX-UK trial; and analysis of qualitative comments from a survey from those who dropped out early from the trial. Quantitative data will be analysed descriptively. We will use thematic analysis in a framework approach to analyse qualitative data. Quantitative and qualitative data will be mixed and integrated to provide an understanding of how the intervention was implemented and how adolescents interacted with the intervention. This process evaluation will explore the experiences of adolescent participants, parents/guardians, eCoaches and clinicians/practitioners in relation to a complex digital intervention.
Ethical approval was granted by the National Health Service (NHS) Health Research Authority South West - Cornwall & Plymouth Research Ethics Committee (Ethics Ref: 22/SW/0149).
Contextualising how the intervention was implemented, and the variations in uptake and engagement, will help us to understand the trial findings in greater depth. The findings from this process evaluation will also inform the decision about whether and how to proceed with a full randomised controlled trial, as well as the development of more effective interventions which can be personalised more precisely via varying levels of human support. We plan to publish the findings of the process evaluation and the wider project in peer-reviewed journals, as well as disseminate via academic conferences.
ISRCTN: ISRCTN15124804. Registered on 16 January 2023,
To explore the experience of primary healthcare (PHC) professionals in their professional role during the pandemic and to describe collective coping strategies.
We conducted a qualitative study using interviews, focus groups and photovoice techniques from February to September 2021. The qualitative data were transcribed, aggregated and analysed, from a hermeneutic perspective, using applied thematic analysis and ethnographic approaches.
Primary Care Health Madrid region (Spain).
Convenience sampling was used to select 71 multidisciplinary primary care professionals who were working in 12 PHCs representing diverse socioeconomic, social vulnerability and COVID impact levels in the Madrid region (Spain).
Findings from this study show how lack of protection in the early days, uncertainty about how the disease would evolve and the daily challenges they faced have had an impact on the participants’ perceptions of their professional role. Nuanced differences in impact were found between men and women, age groups, professional roles and territories. The questioning of the basic foundations of primary care and the lack of prospects led to a feeling of demotivation. They perceive a wide gap between their levels of involvement and commitment, the recognition they receive and the attention to resources they need to do their work to a high standard. The support of their colleagues was seen as the most valuable resource for coping with the crisis.
The practitioners’ discourses offer knowledge that could help to face new global health threats; they also identify an urgent need to restore the role and motivation of PHC professionals as part of a wider regeneration of health systems.
FreshRSS 