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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.
This study describes the prototype testing and clinical validation of the Fit-Frailty App, a fully guided, interactive mobile health (mHealth) app to assess frailty and sarcopenia. This multi-dimensional tool is freely available on the App Store and considers medical history, physical performance, cognition, nutrition, daily function and psychosocial domains. To guide management, a total frailty score and clinical summary of underlying "risk flags" are provided. Our objectives were to examine usability, feasibility, criterion and construct validity.
Cross-sectional
Outpatient geriatric medicine clinic
Community-dwelling older adults, age 65 years or older
The primary outcome of the clinical validation study was criterion validity. A research nurse administered the Fit-Frailty App during a routine clinic appointment. Clinicians simultaneously completed a paper-based frailty index (FI) tool with similar items from a comprehensive geriatric assessment (FI-CGA). Total scores for both assessments were computed using the cumulative deficits frailty index scoring method. Intraclass and Pearson correlation coefficients and 95% CIs were calculated to examine criterion validity. Secondary outcomes were construct validity, feasibility (eg, completion rates, safety occurrences, resources) and usability (eg, ratings on ease of use, time to complete the app).
In the clinical validation study (n=75, mean age 79.2, SD=7.0, 53% female), the mean total Fit-Frailty App score was 0.33 (SD=0.13) with 73% of our sample considered frail or severely frail. The app presented comparable results to FI-CGA (moderate to good validity; ICC=0.65, 95%CI=0.50–0.76) with a strong association between the measures (r=0.74, 95%CI=0.62–0.83). In our prototype and clinical cohorts, the app had a 100% completion rate with no safety occurrences and had high usability ratings.
The Fit-Frailty App is a feasible and valid tool that can be used in research and clinical settings to comprehensively assess frailty and sarcopenia by non-geriatricians and could assist with developing targeted interventions.
To determine the use, frequency and factors linked to the use of any electronic point of care resources (ePOC resources) used by early-career general practitioners (GPs in training, otherwise known as GP residents or registrars) during consultations; and the frequency, and factors linked to the use of evidence-based clinical summaries.
Cross-sectional analysis of data collected as part of the Registrar Clinical Encounters in Training (ReCEnT) project from 2018 to 2022. Every 6 months, GP trainees record 60 consecutive consultations, including information about their use of resources.
Australian training general practices.
3024 GP trainees in community-based vocational training.
The primary outcome was the use of ePOC resources, and the secondary outcome was the use of evidence-based ePOC summaries.
A total of 3024 GP trainees accessed electronic resources during patient encounters for 67 651/628 855 (10.8%) of diagnoses/problems. Use of ePOC resources increased 4% per year over the study period. Therapeutic Guidelines was accessed most often (27 435/79 536, 34.7% of all ePOC use) followed by Australian Medicines Handbook (7507, 9.4%) and HealthPathways (6965, 8.7%). Various factors were associated with increased use of ePOC resources, including increasing patient age, diagnosis/problem type, increasing years of experience prior to GP training and stage of training. GP trainees rarely accessed dedicated evidence-based clinical summaries.
Australian GP trainees use a range of resources to answer their clinical questions, mostly from Therapeutic Guidelines and prescribing compendiums, but also system specific resources that are free to access.
Diets high in ultraprocessed food (UPF) are associated with poor health outcomes and weight gain. Healthcare workers are particularly at risk of consuming diets high in UPF due to erratic work patterns, high stress and limited access to fresh food at work. Despite this, no interventions to date have specifically targeted a reduction in UPF intake in healthcare workers.
This article describes the development and content of a 6-month behavioural support intervention targeting a reduction in UPF intake in UK healthcare workers. The intervention was offered to all participants who took part in the UltraProcessed versus minimally processed Diets following UK dietAry guidance on healTh outcomEs trial—a two-stage study in which Stage 1 was a controlled-feeding crossover randomised controlled trial of provided UPF versus minimally processed food (MPF) diets (published previously) and was completed before the start of Stage 2. Stage 2, reported here, aimed to support participants to reduce their UPF consumption, increase MPF and increase physical activity in real-world settings. The intervention was developed using the behaviour change wheel framework, which systematically links behavioural diagnoses to intervention functions, incorporating the capability, opportunity and motivation model for behaviour change. It included tailored one-to-one and group support sessions, bespoke digital and print resources and a mobile-optimised website. The detailed description is intended to support future replication and adaptation. The acceptability and feasibility of the intervention will be assessed using quantitative and qualitative data in a future paper.
Sheffield Research Ethics Committee approved the trial (22/YH/0281). Findings will be disseminated through peer-reviewed publications, conference presentations and summaries shared with participants and stakeholders.
Prescribing patterns for hyperopia in children vary widely among eye care providers worldwide. This scoping review aims to identify and map the current literature on optical correction and catalogue outcomes reported, particularly in the domains of vision, vision-related functional outcomes and quality of life (QoL) in school-aged children with hyperopia.
This protocol was developed in accordance with the Joanna Briggs Institute’s Manual for Evidence Synthesis. We will include studies involving school-aged children with hyperopia without restrictions on sex, gender, race, ethnicity, type of optical correction, length of intervention, publication date or country of origin. We will include studies with internal or external comparison groups. We will exclude studies associated with myopia control treatments, ocular and visual pathway pathologies affecting vision or visual function. We will search Cochrane CENTRAL, Embase.com and PubMed. Examples of data to be extracted include population demographics, visual acuity, study-specific definitions for refractive error, treatment regimens for optical correction, vision and vision-related functional outcomes and QoL (general or vision-related) as quantified by validated instruments.
Informed consent and Institutional Review Board approval will not be required, as this scoping review will only use published data. The results from the scoping review will be disseminated by publication in a peer-reviewed scientific journal and at professional conferences.
Gambling is now widely acknowledged to be a major public health (PH) issue. The Office for Health Improvement and Disparities conservatively estimated that gambling harm is associated with an annual cost of £1.05–£1.77 billion in England alone. Marionneau et al have categorised gambling harms into seven themes: (1) financial, (2) relationship/conflict, (3) emotional and psychological (mental health), (4) health decrements (physical health), (5) employment/education, (6) cultural and (7) criminal activity. In this understanding, gambling harms are not restricted to individual experiences: they also impact families, the wider community and society, and hence they require a whole systems, PH approach, anchored in population-level interventions to reduce harms. We aim to identify the effects of interventional PH laws and regulations on the harms associated with gambling.
We limit our focus to interventional PH laws and regulations within a comprehensive search of scientific and legal databases, grey literature and books. Following Population, Intervention, Comparator, Outcome, Study, Timing inclusion criteria, evidence will be screened and appraised in Covidence by two reviewers (MF and TP). Included evidence will be analysed and synthesised using a narrative synthesis approach. Methodological quality will be appraised using the relevant risk of bias tool. Randomised controlled trials will be assessed using the Cochrane risk of bias tool (RoB2), Risk Of Bias In Non-randomised Studies - of Interventions (ROBINS-I) will be used for other non-randomised studies. Qualitative studies will be appraised using the EPPI reviewer software for systematic reviewing.
The review protocol is registered with PROSPERO (International prospective register of systematic reviews) at the National Institute for Health Research and the Centre for Reviews and Dissemination (CRD) at the University of York (CRD42024574502). We aim to define a theory of change and produce a context-mechanism-outcome framework with relevant experts using the findings. We plan to disseminate the findings through peer-reviewed publications, meetings with relevant experts and international conference presentations.
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