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☐ ☆ ✇ BMJ Open

Protocol for the development of a global core outcome set for the surgical treatment of sacrococcygeal teratoma in children: a systematic review and international Delphi study

Por: Dongen · M. C. · van Rijn · R. · Sharma · S. · Raphael · M. F. · de Vries · R. · Abouzeid · A. A. · Bugiani · M. · Chirdan · L. B. · van Heurn · E. L. W. · Derikx · J. P. M. · Kremer · M. E. B. · Steering Group · S.-C. — Enero 16th 2026 at 18:44
Introduction

Outcome reporting in studies on sacrococcygeal teratoma (SCT) is highly heterogeneous, which limits comparability across studies and thus hampers the development of international treatment guidelines.

Variation in treatment and access to facilities contributes to differences in outcome reporting between centres and countries. Establishing a Core Outcome Set (COS) can improve consistency in outcome reporting and facilitate global collaboration and data comparison. We therefore aim to develop a Core Outcome Set for SCT (COS-SCT) using the Delphi method to achieve consensus on key outcomes. This will enhance the standardisation of outcome reporting and improve the quality of research and clinical care for SCT patients globally.

Methods and analysis

The development of the COS-SCT will consist of three phases. First, a systematic review will be performed to identify outcomes reported in studies on the surgical treatment of SCT in children. Second, an international Delphi survey will be conducted among key stakeholders, including clinicians, researchers and patient representatives, to establish consensus on outcome prioritisation. Finally, a consensus meeting with representatives from all stakeholder groups will be held to ratify the final Core Outcome Set. The study will follow methodological guidance from the Core Outcome Measures in Effectiveness Trials (COMET) initiative and will be developed and reported in accordance with the Core Outcome Set Standards for Development (COS-STAD) and Core Outcome Set Standards for Reporting (COS-STAR).

Ethics and dissemination

The medical research ethics committee of the Amsterdam University Medical Centre (Amsterdam UMC) confirmed that the Dutch Medical Research Involving Human Subjects Act (WMO) does not apply to this study, and therefore a full review by the ethics committee is not required. This study is registered in the COMET initiative database. Results will be disseminated in peer-reviewed academic journals and conference presentations.

Trial registration number: COMET registration number 3485

☐ ☆ ✇ BMJ Open

Gender differences in clinical features, comorbidities and prognostic outcomes in idiopathic pulmonary fibrosis--a retrospective cohort analysis from the British Thoracic Society Interstitial Lung Disease Registry

Por: Sia · L. C. · Amanda · G. · Baczek · K. · Achaiah · A. · Sese · L. · Chaudhuri · N. · On Behalf of the British Thoracic Society Interstitial Lung Disease Registry Steering Group · Bloye · Chua · Dixon · Fletcher · Hewitt · Hodkinson · Khan · Minnis · Morris · Naqvi · Palmer · S — Octubre 28th 2025 at 18:00
Background

Idiopathic pulmonary fibrosis (IPF), an unknown aetiology type of interstitial lung disease (ILD), carries the poorest prognosis and is more common in males and the elderly. Gender differences in baseline presentation, lung function and comorbidities may have an impact on prognostic outcomes.

Objective

The aim of this study was to explore gender differences in clinical features, comorbidities and outcomes in IPF in a UK cohort.

Method

This was a retrospective cohort study analysing data from the British Thoracic Society UK IPF ILD Registry from January 2013 to February 2024. We compared baseline characteristics between males and females, and a survival analysis in both genders was performed using the Cox proportional hazards model.

Results

We identified 6666 IPF patients with a mean age at diagnosis of 74.1±8.1. Our cohort was predominantly male (5197, 78%), with a higher proportion of current and ex-smokers compared with females (69.9% vs 59.9%, p

Conclusion

Gender differences in baseline characteristics and prognostic factors were observed in IPF. A gender-based approach in managing IPF is warranted, and further studies are needed to clarify these differences and their impact on IPF management.

☐ ☆ ✇ BMJ Open

Core outcome set and measures of chest health in children and young people with cerebral palsy in the community setting: the CHESTI study protocol

Por: Knight Lozano · R. · Morris · C. · Shannon · H. · Bell · K. · Malyon · H. · Melluish · J. · Latour · J. · CHESTI-study steering group · Andrews · Crombie · Gibson · Grace · Goddard · Kolawole · Lowndes · McNamara · Pilbury · Rapson · Scivier · Sellers · Weighton · Winston — Agosto 12th 2025 at 03:13
Introduction

Poor chest health is the leading cause of early mortality in children with cerebral palsy (CP). It is also the most common reason to seek healthcare, accruing significant costs and reducing quality-of-life for children and families. Clinical trials examining chest health interventions in CP are characterised by inconsistent outcome measures, limiting the capacity for evidence synthesis to inform clinical application. The study aims to develop a core outcome set (COS) and related measurement instruments to assess, monitor and evaluate chest health in children with CP, both in research and routine clinical practice. The COS will reflect the views of children, young people, parent/carers, clinicians and researchers, emphasising under-represented groups in research and those at risk of poorer chest health.

Methods and analysis

A 3-phase methodology will be conducted in line with the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. (1) Candidate outcomes will be identified through a qualitative evidence synthesis and interviews with key stakeholders. Findings will be mapped to COMET-taxonomy, generating a list of candidate outcomes. (2) An international e-Delphi survey will invite stakeholders to rate the importance of each outcome, followed by a consensus meeting to ratify the COS. (3) A structured review, guided by health measurement taxonomy, will evaluate relevant instruments, with a final meeting to agree on recommended measures for each COS domain.

Ethics and dissemination

Ethical approval was provided by the University of Plymouth Research Ethics Committee for the qualitative interview study (ID5116), e-Delphi study and consensus meeting (ID5636). Study findings will be published open access in a peer-reviewed journal and presented at relevant national and international conferences.

Study registration

COMET registration: 2590 (https://www.comet-initiative.org/Studies/Details/2590)

PROSPERO registration number

CRD42024562735.

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