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AnteayerBMJ Open

My Story and Me: protocol for a feasibility study of a personalised public mental health intervention for young women aged 14-18 years

Por: Labno · A. · Abel · K. M. · Aked · H. · Bhui · K. · Brooks · H. · Crease · M. · Deighton · J. · Edridge · C. · Fonagy · P. · Grace · E. · Heslin · M. · Leyera · S. T. · Nisbet · K. · Obateru · A. · Norton · S. · Ravaccia · G. · Stapley · E. · Edbrooke-Childs · J.
Introduction

Rates of mental health difficulties among girls and young women in the UK have risen sharply, and disproportionately so for those from marginalised groups. My Story and Me is a new digital public mental health intervention that uses storytelling to reduce stigma, increase awareness and support early help-seeking among girls and young women aged 14–18. The feasibility study aims to determine the acceptability of the intervention and future full trial, including assessing optimal settings and meaningful changes in the primary outcome measure (anxiety and depression).

Methods and analysis

This is an 18-month mixed-methods, uncontrolled feasibility study conducted in secondary schools, further education colleges and community organisations across the UK. We will recruit 120–180 participants. Quantitative data will be collected at baseline and 7-month follow-up. The primary outcomes are anxiety and depression, and secondary outcomes are social support, mentalising, stigma, quality of life, loneliness, empowerment, intervention acceptability, resource use and randomisation acceptability. Platform-level engagement data will assess adherence and fidelity. Qualitative interviews with young women and staff will explore acceptability, feasibility, mechanisms of change and views on trial procedures, including randomisation in a future full trial. Analysis will be descriptive and exploratory, including comparisons across settings and priority groups (LGBTQIA+, neurodivergent and those experiencing digital poverty). A framework and reflexive thematic analysis approach will be used for qualitative data. Prespecified progression criteria will inform decisions about advancing to a full cluster randomised trial.

Ethics and dissemination

The University College London Research Ethics Committee (0692) has approved the My Story and Me protocol. Interested participants will be required to complete an expression of interest and consent form to take part in the study, and young people under 16 years old will be required to obtain parent/carer informed consent. Results will be disseminated through peer-reviewed publications, lived experience summaries, a policy briefing and academic conference presentations.

Trial registration number

ISRCTN12191423.

Utility of Xpert MTB/RIF using bronchoalveolar lavage samples for the diagnosis of pulmonary tuberculosis in negative or sputum-scarce adults: a systematic review and meta-analysis protocol

Introduction

Tuberculosis is the leading cause of death globally from a single infectious agent. Early diagnosis is critical to reducing morbimortality. In cases of negative smear microscopy or limited sputum production, bronchoalveolar lavage (BAL) samples offer an alternative for diagnosis. Culture, the gold standard, requires a high bacterial load, extensive infrastructure and is time-consuming. Xpert MTB/RIF provides faster results with a higher cost. Previous systematic reviews present substantial limitations, including significant heterogeneity. Therefore, the diagnostic utility of Xpert MTB/RIF using BAL samples in adults with negative or scant sputum for pulmonary tuberculosis (PTB) needs to be reassessed.

Methods and analysis

A systematic search of MEDLINE, Embase, LILACS and Web of Science will be conducted without language or publication date restriction. Cross-sectional diagnostic studies of negative or sputum-scarce adults with presumptive PTB who underwent bronchoscopy to obtain samples for Xpert MTB/RIF and culture will be included. Screening and data extraction will be performed independently. Methodological quality will be assessed using the QUADAS-2 tool. A bivariate hierarchical random-effects model will synthesise sensitivity and specificity. Meta-analysis will be performed using Meta-DiSc 2.0. Heterogeneity will be assessed using I2 and Cochrane thresholds. Subgroup analyses will be performed based on study design, population differences, country, culture method and risk of bias. Publication bias will be investigated using a funnel plot. The certainty of evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach. There was no patient or public involvement in the development of the systematic review protocol.

Ethics and dissemination

Ethical approval is not required as this study will use publicly available data. Findings will be disseminated through peer-reviewed publication.

PROSPERO registration number

CRD42025639440.

STRATUM-OS: first step in the development and validation of the STRATUM tool based on multimodal data processing to assist surgery in patients affected by intra-axial brain tumours - observational study protocol

Por: Fabelo · H. · Ramallo-Farina · Y. · Morera · J. · Pineiro · J. F. · Lagares · A. · Jimenez-Roldan · L. · Burström · G. · Garcia-Bello · M. A. · Garcia-Perez · L. · Falero · R. · Gonzalez · M. · Duque · S. · Rodriguez-Jimenez · C. · Hernandez · M. · Delgado-Sanchez · J. J. · Paredes
Introduction

Integrated digital diagnostics can support complex surgeries in many anatomic sites, and brain tumour surgery represents one of the most complex cases. Neurosurgeons face several challenges during brain tumour surgeries, such as differentiating critical tissue from brain tumour margins. To overcome these challenges, the STRATUM project will develop a 3D decision support tool for brain surgery guidance and diagnostics based on multimodal data processing, including hyperspectral imaging, integrated as a point-of-care computing tool in neurosurgical workflows. This paper reports the protocol for the development and technical validation of the STRATUM tool.

Methods and analysis

This international multicentre, prospective, open, observational cohort study, STRATUM-OS (study: 28 months, pre-recruitment: 2 months, recruitment: 20 months, follow-up: 6 months), with no control group, will collect data from 320 patients undergoing standard neurosurgical procedures to: (1) develop and technically validate the STRATUM tool and (2) collect the outcome measures for comparing the standard procedure versus the standard procedure plus the use of the STRATUM tool during surgery in a subsequent historically controlled non-randomised clinical trial.

Ethics and dissemination

The protocol was approved by the participant ethics committees. Results will be disseminated in scientific conferences and peer-reviewed journals.

Trial registration number

NCT07036783.

Trajectories of cigarette smoking and exposure to welding fumes and their impact on lung cancer risks: a latent class modelling approach

Por: Kendzia · B. · Taeger · D. · Pohabeln · H. · Ahrens · W. · Wichmann · H.-E. · Jöckel · K.-H. · Brüning · T. · Behrens · T.
Objectives

Traditional epidemiological approaches usually assume a constant relationship between cumulative exposure and disease, which implies that exposure duration and intensity contribute equally to the studied outcome. But individuals with the same cumulative exposure but different temporal exposure patterns may show different risks. Trajectory classification is a good way to assess exposure–risk associations and leads to a better understanding of lifetime variability in exposure levels. Therefore, this study aimed to estimate lung cancer risk according to the exposure trajectory classes on welding fumes and cigarette smoking.

Design

Two population-based German case–control studies.

Participants

3498 male lung cancer cases and 3539 male control subjects.

Methods

Separate latent class mixed models (LCMM) were determined to identify profiles of exposure trajectories of cigarette smoking and occupational exposure to welding fumes. To investigate the risk of lung cancer by class membership, ORs with 95% CI were estimated via multiple logistic regression analyses.

Results

LCMM each identified four latent classes of smoking and welding-fume exposure. Classes of smokers showed much higher risk of lung cancer compared with never smokers or subjects exposed to welding fumes. Smokers in one class characterised with the highest exposure over the past 10 years had the highest adjusted lung cancer risk (OR=39; 95% CI 29 to 53). For welding, the highest lung cancer risks were found for the class in which exposure to welding fumes in the past 10 years prior to the diagnosis of lung cancer was highest and the duration of welding was also quite high (OR=1.71; 95% CI 0.92 to 3.15).

Conclusions

In summary, LCMM opens a new perspective on dose–effect relationships and could be employed to complement established epidemiological methods.

Quantifying cross-sectional and longitudinal associations in mental health symptoms within families: network models applied to UK cohort data

Por: Bai · Y. · Rayner · A. · Abel · K. M. · Cartwright-Hatton · S. · Wan · M. W. · Pierce · M.
Objectives

Families offer promising targets for mental health interventions. Existing evidence investigates parent-child dyads or partners; we use an innovative approach to look at triads of parents and their children. This gives us more detail on mental health dimensions and individuals central to mental health transmission in families.

Design

Both cross-sectional and longitudinal network models

Setting

We identified triads of children (under age 16), mothers and fathers from the UK Household Longitudinal Study, between 2009 and 2022.

Participants and methods

Cross-sectional networks captured independent associations between family members’ mental health (n=8795 families). Longitudinal networks examined directional temporal associations among family members’ emotional symptoms (n=3757 families).

Primary outcome measures

Children’s and parents’ mental health dimensions were assessed using the Strengths and Difficulties Questionnaire and the General Health Questionnaire, respectively.

Results

Mothers’ mental health, particularly emotional symptoms, was linked to children’s mental health, while fathers’ symptoms showed no independent association. In the longitudinal network, maternal feelings of being overwhelmed were associated with children’s future worry, affecting symptoms of nervousness and unhappiness, which then fed back into worsening maternal emotional symptoms.

Conclusions

Investigating family mental health using network models highlights mothers’ central role. The longitudinal relationship between maternal feelings of being overwhelmed and children’s anxiety, and the subsequent feedback into maternal anxiety, indicates a promising target for intervention.

Development and validation of clinical vignettes to inform an educational intervention for physiotherapists to detect serious pathologies: a mixed-methods study

Por: Lackenbauer · W. · Gasselich · S. · Lickel · M. E. · Schabel · L. · Beikircher · R. · Keip · C. · Wieser · M. · Selfe · J. · Mazuquin · B. · Yeowell · G. · Janssen · J.
Objectives

To develop and validate educational clinical vignettes (CVs) based on real-life patients with serious pathology from the disciplines of oncology, internal medicine and orthopaedics that are relevant for physiotherapists (PTs) working in a non-direct access system.

Design

A mixed-methods study using an iterative design was employed to develop and validate CVs that focused on serious pathology.

Setting

Academic and clinical settings within health faculties at three universities in Austria and the UK.

Participants

Medical doctors (MD) (n=3) and PTs (n=4) developed CVs in the disciplines of internal medicine, oncology and orthopaedics. Validation of the CVs was undertaken in three stages: internal validation by the research team (n=7), external validation by MDs (n=3) and external validation by PTs (n=18).

Results

25 CVs focusing on internal medicine (9), oncology (8) and orthopaedics (8) were developed. Results of the consensus method of Haute Autorité de Santé ranged between 7 and 9 in the internal validation stage. In the external validation stage with MDs, one orthopaedic CV was excluded, resulting in a final total of 24 validated CVs.

Conclusions

This is the first time educational CVs have been developed and validated across such a broad range of pathologies for countries without direct access to physiotherapy, for use in the education of PTs. Furthermore, the approach described in the Methods section of this paper may serve as a template in similar future projects.

Lay health worker-delivered and technology-based interventions for sexual and reproductive health among adolescents and young adults in low- and middle-income countries: protocol for a scoping review

Por: Kern · M. · Neumann · C. · Bosompim · B. · Ann · D. · Kurniawan · A. L. · Dlamini · N. · Nabukeera · S. · Machanyangwa · S. · Tewahido · D. · Shinde · S. · DASH Collaborators · Bukenya · J. · Laxy · Burns · Fawzi · Sando · Moshabela · Oduola · Guwatudde · Sie · Berhane · Manu · Bärnig
Background

Adolescents and young adults (AYAs) in low- and middle-income countries (LMICs) are at high risk of harmful sexual and reproductive health (SRH) practices due to limited knowledge, low availability or acceptability of modern contraceptives, gender inequality and cultural practices like child marriage. Preventive and educational interventions by lay health workers or through technological means are a cost-effective and scalable solution. Unfortunately, too little is currently known about the scope, content and conditions of the effectiveness and sustainability of these approaches and synthetic evidence on this topic is scarce. To help fill this knowledge gap and to identify where further research is needed, we will conduct a scoping review of technology-based or lay health-worker delivered preventive and educational SRH interventions targeting AYAs in LMICs. This information is valuable to both policymakers and researchers as it provides a synthesis of existing interventions, highlights best practices for their implementation and identifies potential avenues for future research.

Methods

This review will include studies on SRH preventive and educational interventions targeting AYAs aged 10–24 years in LMICs. It encompasses interventions delivered by lay health workers or via technological means, assessing various outcomes including but not limited to SRH literacy, sexual risk behaviours, pregnancies, sexually transmitted infections and gender-based violence. Key databases, including PubMed via MEDLINE and Embase, will be searched from 1 January 2000 up to 23 January 2024, using a comprehensive search strategy. Screening will be conducted using Covidence software. Data extraction will cover study details, methods, intervention strategies, outcomes and findings. A narrative synthesis will be conducted following synthesis without meta-analysis guidelines.

Ethics and dissemination

The scope of this scoping review is limited to publicly accessible databases that do not require prior ethical approval for access. The findings will be disseminated through peer-reviewed journal publications, as well as presentations at national and international conferences and stakeholder meetings in LMICs.

Scoping review registration

The final protocol is prospectively registered with the Open Science Framework on 7 May 2024 (osf.io/vna2z).

Identifying the key components of a diet and lifestyle screener for people living with and beyond cancer: an e-Delphi study

Por: Chaplin · A. · Prohens · L. · Wordsworth · J. · Obrador-Hevia · A. · Guillot · M. · Ricci-Cabello · I. · Romaguera · D. · Sese · A.
Objectives

There are currently no validated screeners that evaluate diet and lifestyle of people living with and beyond cancer (PLWBC). The purpose of this study was to reach a consensus among an international expert panel on the essential items to include in this type of instrument.

Design

A scientific committee developed the initial list of items, which were presented to an expert panel in a two-round-modified electronic Delphi. Panellists were asked to rate the adequacy, relevance and feasibility of self-reporting each item. Qualitative assessments were encouraged.

Setting

Four countries (Spain, UK, USA and Portugal).

Participants

Experts working in a cancer-related health profession or cancer-related research were recruited.

Main outcome measures

Items were initially categorised into seven domains (body composition, physical activity, diet, alcohol, smoking, sleep and psychosocial distress). A content validity index per item (CVI-i) and a scale-level CVI (S-CVI) were calculated (acceptable≥0.78). All items with a CVI-i≥0.78 were submitted to a final consensus meeting.

Results

A total of 108 items were proposed to the panel. In Round 1, 77 items were accepted, 10 items were excluded and 6 new items were proposed. During Round 2, 4 items were accepted and 19 were excluded. Diet and alcohol were merged into one domain. The final consensus meeting decided on 61 items categorised into six domains (S-CVI:0.94): body composition, physical activity, diet and alcohol, smoking, sleep and psychosocial distress.

Conclusions

We identified the main items to be considered when developing a screener to evaluate diet and lifestyle in PLWBC in a clinical setting, and the results obtained will guide the content of the screener in the following validation study.

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