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☐ ☆ ✇ BMJ Open

Pragmatic, open-label, multicentre, randomised controlled trial to guide initial therapy for immune checkpoint inhibitor-induced inflammatory arthritis comparing standard of care (prednisolone) to adalimumab without glucocorticoids: REACT trial protocol

Por: Fisher · B. A. · Rowe · A. · Hodson · C. · Wilkhu · M. · Williams · E. · Turner · E. · Allard · A. · Blake · T. · Bombardieri · M. · Cope · A. P. · Dubey · S. · Mankia · K. · Malley · T. · Moore · O. · Payne · M. · Plummer · R. · Tilby · M. · Tillett · T. · Wong · E. · Wu · Y. · Filer · A. · Pra — Marzo 3rd 2026 at 13:40
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

ISRCTN18217497.

☐ ☆ ✇ BMJ Open

Evaluating adherence to patient registration paperwork guidelines: a mystery shopper study in English primary care

Por: Hodson · N. · Onyeaso · O. O. · Mills · S. · Sunstein · C. R. · Bruine de Bruin · W. — Noviembre 12th 2025 at 07:02
Objective

To evaluate adherence to National Health Service (NHS) patient registration ID guidelines among General Practitioners’ (GP) practices.

Design

A mystery shopper study, including website reviews and phone calls.

Setting

Rural and urban parts of the United Kingdom’s West Midlands.

Participants

85 randomly selected GP practices.

Primary and secondary outcome measures

In January–April 2024, GP’s websites were reviewed before phone calls in which our ‘mystery shopper’ was asked to register without photo ID and proof of address.

Results

Of 85 GP practices, 60 (71%) breached NHS guidance either online or over the phone, with only 25 (29%) consistently following NHS guidance. Phone calls to rural (vs urban) GP practices were more likely to yield refusal of registration without photo ID and proof of address, despite rural (vs urban) GP practices making similar statements online. During some phone calls, practices sought to negotiate a compromise by requesting less robust ‘documentation’, such as an addressed parcel.

Conclusions

GP practices commonly refuse registration to people without photo ID or proof of address, thus creating ‘sludge’ and undermining access to healthcare especially for poor, vulnerable patients, including immigrants. Changing GP practices’ websites would not address this problem if erroneous information is still provided over the phone. GPs and practice managers should ensure that all staff follow NHS guidance to allow registration without these documents.

☐ ☆ ✇ BMJ Open

Preparing for cognitive behavioural therapy: a Delphi exercise to develop a consensus curriculum

Por: Turtle · L. · Hodson · N. · Wesson · H. · Williamson · S. T. · Giacco · D. — Agosto 7th 2025 at 01:15
Aim

To develop a consensus curriculum describing what information service users should be given prior to cognitive behavioural therapy (CBT).

Design

A Delphi study was undertaken. Following development work with professionals and experts by experience, 30 initial statements were prepared and survey rounds were undertaken until 90% of statements achieved 80% consensus on inclusion or exclusion.

Setting

NHS Talking Therapies services in England provide CBT following referral by a professional or self-referral. Out of 1.7 million referrals in 2022–2023 more than 1 million disengaged before or during therapy. Ensuring patients are adequately prepared for CBT is one promising approach to improving engagement and outcomes.

Participants

Participants were only included if they had either 3 years of clinical experience in NHS Talking Therapies services or a leadership role in NHS Talking Therapies services. They reported current employment at seven NHS Trusts in England as well as private practice.

Results

Of the 41 participants, 36 completed all three rounds. After three rounds, 27 statements were included by consensus in the curriculum, covering six domains: Emergency information (two statements), What is CBT? (six statements), Practical preparation for CBT (five statements), What does a CBT session look like? (five statements), What is CBT not? (two statements) and How can people get the most out of CBT? (seven statements).

Conclusions

This consensus curriculum provides a basis for ensuring patients are well-prepared for CBT within the context of NHS Talking Therapies. Further research on improving engagement and outcomes from NHS Talking Therapies services should aim to address these 27 topics.

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