Objective Some individuals present with symptoms before rheumatoid arthritis (RA) develops, and trials suggest that early treatment during this at-risk phase may be effective. This study evaluated the cost-utility of three imaging strategies—conventional MRI, modified Dixon MRI and ultrasound—combined with early treatment compared with watchful waiting in individuals at risk of RA, stratified by autoantibody status.Design A decision tree combined with a Markov model was developed to estimate costs and quality-adjusted life years (QALYs) over a 2-year time horizon. Model inputs were derived from the TREAT EARLIER trial for treated patients at risk of developing RA, clinically suspect arthralgia (CSA) cohorts for untreated at-risk patients and the early arthritis clinic for patients with undifferentiated arthritis or RA. Cost-utility analyses were conducted from both the societal- and healthcare perspectives. Probabilistic and deterministic sensitivity analyses were conducted to assess the uncertainty of the results, and several scenarios were explored.Setting Dutch hospital setting.Participants Individuals at risk of developing RA, stratified by autoantibody status.Interventions Watchful waiting was compared with three imaging strategies—conventional MRI, modified Dixon MRI and ultrasound—combined with early treatment (single intramuscular glucocorticoid injection and 1-year methotrexate course) in patients with positive subclinical inflammation.Outcome measure Incremental cost-effectiveness ratios (ICERs) of the interventions compared with watchful waiting. Cost-effectiveness probabilities were estimated at a willingness-to-pay (WTP) threshold of €50,000 per QALY.Results From a societal perspective, autoantibody-positive patients showed cost savings of €1,183 (-5348 to 2861) (ultrasound) to €1,825 (-8041 to 3861) (modified Dixon MRI). Autoantibody-negative patients had incremental costs from €21 (-3843 to 3856) (conventional MRI) to -€409 (-4499 to 3681) (modified Dixon MRI). QALYs gained ranged from 0.006 (-0.04 to 0.06) to 0.016 (-0.08 to 0.11). Probability of cost-effectiveness was 75%–80% for autoantibody-positive patients and 56%–70% for autoantibody-negative patients at a WTP of €50 000/QALY. Results were less pronounced from a healthcare perspective. Deterministic sensitivity analysis showed the results were robust to most changes in parameters; however, the results were sensitive to extreme changes in parameters related to treatment effects on quality of life (QoL) and productivity and disutilities due to treatment-related side effects.Conclusions Imaging-guided early treatment for arthralgia at-risk for RA may be cost-effective, particularly for autoantibody-positive patients, irrespective of imaging modality. Modified Dixon MRI seems most promising and requires further validation in CSA.Trial registration TREAT EARLIER trial: EudraCT, 2014–004472-35 and the Netherlands Trial Register, NTR4853-trial-NL4599.
Introduction Small-cell lung cancer (SCLC) is an aggressive neuroendocrine malignancy with a poor overall prognosis. Surgery and concurrent chemoradiotherapy are currently recommended treatments for limited-stage SCLC (LS-SCLC), yet their efficacy remains limited. Recent advances have demonstrated the promising role of immunotherapy in LS-SCLC, reshaping the treatment paradigm. In parallel, neoadjuvant chemoimmunotherapy has become a standard of care for resectable non-small cell lung cancer. These provide a compelling rationale for exploring similar strategies in LS-SCLC to improve outcomes. We therefore conducted this study to evaluate the efficacy and safety of a novel neoadjuvant regimen incorporating adebrelimab, apatinib and chemotherapy in patients with LS-SCLC and to explore relevant biomarkers.Methods and analysis This is a single-arm, multicentre, prospective, exploratory phase II trial. A total of 38 patients with untreated, resectable LS-SCLC will receive four cycles of neoadjuvant therapy: adebrelimab (1200 mg, every 3 weeks (q3w)), apatinib (250 mg every other day (qod), 3 times/week, q3w for three cycles), and chemotherapy (etoposide plus carboplatin, q3w). Surgery is scheduled 4–8 weeks after neoadjuvant treatment (with a 4-week apatinib washout), followed by adjuvant adebrelimab plus apatinib with or without radiotherapy based on multidisciplinary assessment. The primary endpoint is 2-year event-free survival rate. Secondary endpoints include pathological complete response, major pathological response, objective response rate, overall survival, event-free survival and safety. Exploratory biomarker analyses using tumour tissue and serial blood samples will employ spatial single-cell sequencing, proteomics and circulating tumour DNA for minimal residual disease monitoring. We also use the tumour microenvironment using high-resolution spatial transcriptomics to explore the changing dynamics of tumour in situ trying to obtain the mechanistic explanation for potential non-responders.Ethics and dissemination This study was approved by the Medical Ethics Committee of Zhejiang Cancer Hospital, on 3 May 2024 (approval number IRB-2024-420 (IIT)). The version of this study protocol is V.8.0, dated 16 December 2025. The patients have been enrolled since June 2024. All participants will provide written informed consent. Results will be published in peer-reviewed journals and presented at scientific conferences.Trial registration number NCT06483282.
Introduction Prediabetes, a key precursor to type 2 diabetes, is highly prevalent and underdiagnosed, particularly among adults aged ≥45 years with elevated body mass index (BMI). Early detection is critical because lifestyle interventions can delay or prevent progression to type 2 diabetes. The Glucose Observation and Wearable Use for Prevention (Glow Up) study aims to (1) test the feasibility of a digital biomarker for pre-diabetes screening using wearable- and smartphone-derived lifestyle factors (eg, sleep, physical activity and nutrition patterns) in daily life and to (2) characterise individual- and metabolic subgroup-level variability in lifestyle factors and glycaemic control. Specifically, we aim to examine how lifestyle factors relate to glycaemic status and identify personalised predictors of early metabolic dysregulation.Methods and analysis Glow Up is a prospective, single-centre, observational case-control study conducted in Switzerland. Adults (n=200) aged ≥45 years with body mass index (BMI) ≥25 kg/m² will be recruited, including n=100 individuals with pre-diabetes and n=100 age- and sex-matched normoglycaemic controls. Participants will undergo 4 weeks of continuous monitoring using a blinded continuous glucose monitor (CGM) and commercial- and medical-grade wearables; for example, capturing physical activity, sleep and physiological markers (heart rate variability, heart rate and skin temperature), in addition to completing daily image-based meal logs using smartphones. Glycated haemoglobin (HbA1c), fasting plasma glucose (FPG) and body anthropometrics will be collected at the enrolment visit (T0) and repeated at follow-up (T3), approximately 5 weeks apart. The primary outcome is glycaemic status at T3, classified from HbA1c and FPG using prespecified thresholds. Secondary outcomes include CGM metrics, lifestyle profiling (sleep, physical activity, stress and nutrition) and adherence to image-based meal logging.Ethics and dissemination The study received ethics approval from the Ethics Committee of Eastern Switzerland on 15 May 2025 (BASEC ID: 2025–00972). Written informed consent is obtained from all participants before any study procedures are performed. Findings will be disseminated as articles in international peer-reviewed journals and as posters and oral presentations at national and international conferences. Summaries will be provided to funders and collaborators, and personalised reports to participants.Trial registration number NCT07373418.
Introduction Members of the European Society for Dermatology and Psychiatry (ESDaP) are interested in the connection between the psyche and presence and severity of skin diseases. Two former multicentre studies initiated by ESDaP-members focused on the psychological burden of patients with skin diseases in comparison to healthy skin controls. The previous studies focused on depression, anxiety, stress, perceived stigmatisation and body dysmorphia. The main objective of the present study is to assess coping, loneliness and resilience in patients with skin conditions and to compare them with healthy skin controls. In the literature, these aspects have rarely been investigated in patients with skin conditions. A secondary aim is to examine the impact of the skin disease on the patient’s partner and to analyse the factors associated with this possible impact on quality of life (QoL) (QoL of patients, socio-demographic, disease-related and psychological parameters).Methods and analyses Data will be collected in 23 study centres across 15 European countries. At each study centre, 250 outpatients with different skin conditions as well as 125 healthy skin controls will be recruited, resulting in a total sample size of n=8625. In addition to a background questionnaire to gather socio-demographic and disease-related data, validated questionnaires to measure coping (Brief-Coping Orientation to Problems Experienced Inventory (Brief-COPE)), loneliness (UCLA Loneliness Scale 8 (ULS-8)), resilience (Brief Resilience Scale), sleep disorders (Insomnia Severity Index), symptoms of depression (Patient Health Questionnaire-2) and anxiety (Generalised Anxiety Disorder-2), general health (Visual Analogue Scale of the EuroQol 5-Dimension) and a skin health questionnaire (Skin Well-Being Scale) will be applied. In patients, health-related quality of life will additionally be examined by means of the Dermatology Life Quality Index. All patients with a partner will additionally receive the Family Reported Outcome Measure 16, a questionnaire that is supposed to be filled in by their partners to evaluate the impact of disease on the partner.Ethics and dissemination The study protocol was approved by the University of Giessen in March 2026 (approval number 1435/2026) and will be approved by each participating recruitment centre. Study results will be disseminated by publication of the results at (inter-) national conferences and in scientific journals.
Objectives To explore experiences and perspectives on diagnosis and management among individuals living with prediabetes or early type 2 diabetes.Design Qualitative study using semi-structured virtual interviews and Braun and Clarke’s reflexive thematic analysis.Setting British Columbia, Canada.Participants 12 adults (≥18 years) diagnosed with prediabetes (6.0%≤haemoglobin A1C≤6.4%) or early type 2 diabetes (6.5%≤haemoglobin A1C≤7.0%) within the past 5 years. We used purposeful sampling to recruit eligible participants through an online health research platform.Results We developed three main themes: (1) ‘Mixed feelings about early detection’ captured the emotionally complex experience of an early diagnosis and the evolving process of sense-making beyond the initial response; (2) ‘Knowledge: a powerful enabler of self-management’ highlighted the role of timely, trusted and meaningful information and how understanding both the risks and the manageability of the condition can motivate action; (3) ‘Care that fits people’s lives’ reflected individuals’ need for supportive and individualised care and their view of lifestyle changes as the foundation of management, with medication to fill gaps if needed.Conclusions Centred on the lived experiences of people with prediabetes and early type 2 diabetes, this study highlights the emotional complexity of these diagnoses and the need for care that supports contextualised empowerment and individualised management. The insights from this study can inform patient-centred clinical practice, policy and resource co-design for prediabetes and early type 2 diabetes.
