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☐ ☆ ✇ BMJ Open

Fibroblast-Neuron interactions Driving persistent Pain in Rheumatoid Arthritis (FiND-Pain RA) - an observational study protocol

Por: Xenophontos · M. · Baldeweg · F. C. · Ross · R. · Rutter-Locher · Z. · Hill · S. · Ryan · S. · Ali Awadelkareem · M. · Law · S. T. · Bennett · D. L. · Buckley · C. D. · Humby · F. · Kirkham · B. W. · Denk · F. · Taams · L. S. — Diciembre 25th 2025 at 12:35
Introduction

Pain in patients with rheumatoid arthritis (RA) is an unmet clinical need. Targeting joint inflammation with disease-modifying antirheumatic drugs has not resulted in the anticipated reduction in pain for many patients. This can partly be explained by the concept of central sensitisation whereby spinal and supraspinal pathways have a lower threshold of activation, leading to increased perception of pain. Synovial stromal cells, such as fibroblasts, are also thought to play a role through peripheral sensitisation of nerves in the joint. Synovial fibroblasts are known to produce pro-algesic mediators such as interleukin 6 and nerve growth factor at the messenger RNA level. These pro-algesic mediators could activate sensory nerve fibres that send signals from the joint to the spinal cord, thereby driving persistent pain in RA. The purpose of this study is to evaluate which pro-algesic mediators are produced by lining versus sub-lining fibroblasts and whether the level of these mediators correlates with clinical measures of pain in patients with RA.

Methods and analysis

FiND-Pain RA is a multicentre observational study which will recruit 50 patients with seropositive RA who attend the rheumatology department of Guy’s and St Thomas’ Hospital, London, and the Nuffield Orthopaedic Centre, Oxford. Clinical examination, pain-focused patient-reported outcome measures, ultrasound examination and ultrasound-guided synovial biopsy of the knee will be performed. The levels of known and putative pro-algesic mediators will be measured in fibroblasts from the lining and sub-lining layer of the synovium. The location and spatial morphology of sensory nerve fibres and their proximity to lining and sub-lining fibroblasts will be characterised. The primary outcome will be to determine whether the knee pain scores of participants correlate with the level of leukaemia inhibitory factor, a novel putative pain-mediator expressed in sub-lining fibroblasts. The secondary outcomes will be to determine whether other pro-algesic mediators produced by lining or sub-lining fibroblasts correlate with clinical measures of pain and to assess the location and proximity of sensory nerve fibres to lining versus sub-lining fibroblasts.

Ethics and dissemination

The study is a sub-study of the PUMIA (Pain Phenotypes and their Underlying Mechanisms in Inflammatory Arthritis) study, which has been approved by the Bromley Research Ethics Committee (REC: 21/LO/0712). The findings of this study will be disseminated through open-access publications, as well as scientific and clinical conferences.

☐ ☆ ✇ BMJ Open

Promoting vitality in a sheltered workplace: a realist evaluation protocol

Por: Bom · S. · Hollaar · M. · Denktas · S. · Kocken · P. — Octubre 28th 2025 at 01:46
Introduction

Employees in sheltered workplaces face greater challenges in maintaining a healthy and vitality-enhancing lifestyle due to physical, mental and psychosocial disabilities. While workplace health and vitality programmes are particularly relevant for this group, evaluation of programmes in this setting remains limited. This paper presents a protocol for a realist evaluation of a sheltered workplace’s vitality programme aimed at physical, mental and social sources of vitality.

Methods and analysis

Using a multimethod design with adaptive qualitative methods, we developed an initial programme theory that describes how context and mechanisms of the sheltered workplace’s vitality programme influence the outcomes related to physical activity, healthy eating and social interaction. The protocol explains how we will collect and synthesise qualitative data, interviews, observations and focus group discussions, to refine and validate this initial programme theory and further evaluate the vitality programme. We aim to conduct at least 15 interviews, 15 observations, 3 focus group discussions and 1 final validating focus group. The study includes recipients of the intervention, namely individuals with varying work abilities, as well as other key stakeholders involved in the vitality programme. In this way, we will get insights into how to promote vitality-enhancing behaviours. Our context-sensitive methodology offers both scientific and practical value for future research in similar settings.

Ethics and dissemination

Ethical approval was granted through the Ethics Review Committee of Erasmus University Rotterdam (application number: ETH2324-0939). Findings will be disseminated through presentations, conferences, social media and peer-reviewed publications.

☐ ☆ ✇ BMJ Open

Current practices for assessing usability of novel point-of-care diagnostics for infectious diseases: a scoping review protocol

Por: Castro · M. d. M. · Ismail · H. M. · Montenegro-Quinonez · C. A. · Reipold · E. I. · Shilton · S. · Denkinger · C. · Yerlikaya · S. — Agosto 7th 2025 at 08:17
Introduction

Novel diagnostics, particularly point-of-care (POC) tests, play a crucial role in the early detection and management of infectious diseases, especially in resource-limited settings. Ensuring test performance and quality while minimising the risk of human error becomes more relevant when shifting testing tasks from highly controlled settings like centralised laboratories to people with minimal training. Applying usability and human factors engineering principles can reduce the challenges related to human errors. Despite existing frameworks and tools, the practical application of usability guidelines remains variable across different settings.

Methods and analysis

This scoping review protocol outlines a systematic investigation of current practices in assessing the usability of novel diagnostics, particularly POC tests for infectious diseases intended for use in low-income and middle-income countries. The review will analyse original research studies of all designs and product dossiers that report on the usability evaluation or validation of a diagnostic test for an infectious disease. A qualitative synthesis of the data extracted from the articles will be conducted. We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols and the Joanna Briggs Institute guidelines for this scoping review.

Ethics and dissemination

No ethical approval is required because individual patient data will not be included. The findings will be disseminated through publication in a peer-reviewed journal.

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