Cardiometabolic risk factors in the Swedish Werlabs cohort based on self-initiated health screening: cohort profile

Purpose
There is limited research on individuals undergoing self-initiated health examinations, and the Werlabs cohort will be a base for such research.

Participants
All individuals aged 18 or older who had undertaken a self-initiated health examination at Werlabs AB with at least one recorded value of creatinine or cholesterol in Sweden (from 1 January 2015 through 31 December 2023) was included. Medical history and anthropometric measurements were self-reported through an online questionnaire. We describe cohort baseline characteristics, demographic variables and cardiometabolic risk factors.

Findings to date
The study population includes 149 556 individuals who provided at least one health screening. The median (IQR) age was 43 (33–54) years and 54% were women. The most common self-reported chronic disease was hypertension (4.5%), followed by cardiovascular disease (0.9%) and 12.6% reported values of obesity. The prevalence was 2.1% for diabetes, 1.2% for kidney disease (including an estimated glomerular filtration rate of 3.0 mmol/L and 4.1% for anaemia (haemoglobin

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Gennaio 2025

Trials and tribulations: a qualitative exploration of researcher perspectives on navigating the challenges of health system implementation research

Objective
While researchers are crucial to the successful delivery of implementation trials, their perspectives are rarely captured in the evaluation of these trials. This qualitative study aimed to capture the experiences of a small research team coordinating a large, multisite implementation trial (the Hide and Seek Project) in the Australian healthcare setting.

Design
A qualitative approach was used, whereby members of the Hide and Seek Project research team were invited to take part in semistructured focus groups led by an external facilitator. The focus group guide was developed to explore the experiences of the research team (including challenges and lessons learnt) as they moved through key study activities. Focus groups were transcribed verbatim and analysed using an inductive thematic approach. Barriers and facilitators identified within themes were deductively coded to domains of the updated Consolidated Framework for Implementation Research.

Setting
Participants were recruited from a research organisation based in Sydney, Australia.

Participants
A total of seven researcher and administering institution participants took part in four focus groups.

Results
Analysis highlighted the following themes: navigating bureaucracy, distinguishing implementation trials from clinical trials, the impact of COVID-19, balancing rigour and pragmatism in implementation trials, data access and complexity of analysis, and key learnings and future directions (subthemes: building relationships with ethics committees, communicating implementation concepts, streamlining of the implementation and research approach).

Conclusions
Findings highlight the need for streamlining current administrative and ethical review processes, as well as procedures that allow greater flexibility for researchers to respond to challenges as they arise. Lessons learnt by the Hide and Seek Project team hold potential relevance for fellow researchers involved in coordinating implementation trials across diverse contexts.

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Gennaio 2025

Symptom-related experience and sexual health of female patients with pulmonary arterial hypertension: protocol for a systematic review and qualitative meta-synthesis

Introduction
Pulmonary arterial hypertension (PAH) is a complex condition affecting quality of life, characterised by high blood pressure in the pulmonary arteries leading to heart strain. PAH’s impact extends beyond physical symptoms, influencing emotional and social well-being, particularly in women where it affects sexual health and pregnancy outcomes. Despite medical advancements, the disease’s full impact on women’s lives is under-researched, especially regarding sexual experiences and health. This systematic review and qualitative meta-synthesis aim to address this gap by examining women’s experiences with PAH, informing clinical practice and patient-centred care. The protocol outlines a methodology for synthesising qualitative research to amplify women’s voices and enhance our understanding of PAH’s impact on female patients.

Methods and analysis
Search strategy: A systematic review and thematic meta-synthesis of qualitative research studies and qualitative components of mixed-methods studies will be conducted. The systematic review will be guided by the Joanna Briggs Institute methodological framework. A comprehensive search will encompass seven electronic databases and search engines (Ovid Medline, CINAHL, EMBASE, APA PsycINFO, Cochrane Database of Systematic Reviews, PubMed, Scopus) and grey literature sources (ProQuest Dissertations, ClinicalTrials.gov). Building on insights from previous reviews centred on symptom-related experience and sexual health. Two review authors will independently conduct the screening and data extraction processes. Discrepancies will be resolved through consensus or discussion with a third review author. The review will include English studies from database inception. Findings will be presented graphically and tabularly, together with a narrative description.
Assessment of confidence and data synthesis: The meta-synthesis used thematic analysis, importing study transcripts and notes into NVivo software. Data-derived codes formed categories, which were then iteratively refined into broader themes reflecting women’s experiences with sex and childbirth while living with PAH.

Ethics and dissemination
External ethical approval is not required as this review is a retrospective review, which is undertaking secondary analysis of publicly available primary data. The results will be disseminated in peer-reviewed journals and presented in conference papers and elsewhere. This protocol is registered with PROSPERO prospective database of systematic review.

PROSPERO registration number
CRD42024529342.

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Gennaio 2025

Investigating male factors and their relationships with reproductive health outcomes: a case-control study protocol for Towards Optimal Fertility, Fathering, and Fatherhood studY (TOFFFY) in Singapore

Introduction
Despite the global prevalence of low fertility rates, male contributions to fertility and reproductive health outcomes have been understudied. This study aims to investigate the male contribution to fertility and explore the underlying biological mechanisms. Specifically, we aim to (1) identify male factors associated with successful pregnancy, (2) develop a fertility index incorporating modifiable factors for both males and females to predict pregnancy rate and (3) explore the relationship of male modifiable factors with semen parameters and molecular characteristics.

Methods and analysis
We will conduct an unmatched case-control study involving 240 couples with impaired male fertility (cases) and 240 couples with normal male fertility (controls). Between July 2024 and June 2026, we will recruit 480 eligible couples from KK Women’s and Children’s Hospital, Singapore. Male and female participants will complete questionnaires on sociodemographics, general health and lifestyle factors, and their anthropometry and body fat composition will be measured. Blood and semen samples from the male participants will be collected for biochemical, molecular and semen analyses. Predictive male factors will be identified using the least absolute shrinkage and selection operator method, accounting for female factors. We will construct a logistic regression model incorporating both male and female factors to derive a fertility index, which will be evaluated using cross-validation on subsets of the study population. Multivariable linear regression will be used to explore relationships between male modifiable exposures and semen parameters.

Ethics and dissemination
The study protocol has received approval from the Centralised Institutional Review Board of SingHealth (2024/2120), Singapore. Participants will provide written informed consent. Study results will be disseminated through conferences and peer-reviewed scientific journals.

Trial registration number
NCT06293235.

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Gennaio 2025

Comparison of cardiovascular risk prediction models developed using machine learning based on data from a Sri Lankan cohort with World Health Organization risk charts for predicting cardiovascular risk among Sri Lankans: a cohort study

Introduction
Models derived from non-Sri Lankan cohorts are used for cardiovascular (CV) risk stratification of Sri Lankans.

Objective
To develop a CV risk prediction model using machine learning (ML) based on data from a Sri Lankan cohort followed up for 10 years, and to compare the predictions with WHO risk charts.

Design
Cohort study.

Setting
The Ragama Health Study (RHS), an ongoing, prospective, population-based cohort study of patients randomly selected from the Ragama Medical Office of Heath area, Sri Lanka, focusing on the epidemiology of non-communicable diseases, was used to develop the model. The external validation cohort included patients admitted to Colombo North Teaching Hospital (CNTH), a tertiary care hospital in Sri Lanka, from January 2019 through August 2020.

Participants
All RHS participants, aged 40–64 years in 2007, without cardiovascular disease (CVD) at baseline, who had complete data of 10-year outcome by 2017, were used for model development. Patients aged 40–74 years admitted to CNTH during the study period with incident CV events or a disease other than an acute CV event (CVE) with complete data for CVD risk calculation were used for external validation of the model.

Methods
Using the follow-up data of the cohort, we developed two ML models for predicting 10-year CV risk using six conventional CV risk variables (age, gender, smoking status, systolic blood pressure, history of diabetes, and total cholesterol level) and all available variables (n=75). The ML models were derived using classification algorithms of the supervised learning technique. We compared the predictive performance of our ML models with WHO risk charts (2019, Southeast Asia) using area under the receiver operating characteristic curves (AUC-ROC) and calibration plots. We validated the 6-variable model in an external hospital-based cohort.

Results
Of the 2596 participants in the baseline cohort, 179 incident CVEs were observed over 10 years. WHO risk charts predicted only 10 CVEs (AUC-ROC: 0.51, 95% CI 0.42 to 0.60), while the new 6-variable ML model predicted 125 CVEs (AUC-ROC: 0.72, 95% CI 0.66 to 0.78) and the 75-variable ML model predicted 124 CVEs (AUC-ROC: 0.74, 95% CI 0.68 to 0.80). Calibration results (Hosmer-Lemeshow test) for the 6-variable ML model and the WHO risk charts were 2=12.85 (p=0.12) and 2=15.58 (p=0.05), respectively. In the external validation cohort, the sensitivity, specificity, positive predictive value, negative predictive value, and calibration of the 6-variable ML model and the WHO risk charts, respectively, were: 70.3%, 94.9%, 87.3%, 86.6%, 2=8.22, p=0.41 and 23.7%, 79.0%, 35.8%, 67.7%, 2=81.94, p

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Gennaio 2025

[Articles] A core outcome set for maternal and neonatal health research and surveillance of emerging and ongoing epidemic threats (MNH-EPI-COS): a modified Delphi-based international consensus

This COS could contribute to standardize maternal and neonatal outcomes selection and reporting in observational and experimental studies, facilitating efficient data comparison and timely evidence-based decision-making in the context of ongoing and emerging epidemic threats.

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Gennaio 2025

Community health system capacities and capabilities within an evolving community health policy framework: mixed methods study of stakeholders in central Uganda

Objectives
Empowering communities through identifying and unlocking community capacities and capabilities is vital for improving community health systems. This study assessed the community health system’s status quo and readiness for implementing a government-led, partner-supported community health worker project.

Design
A mixed methods cross-sectional study.

Setting
Two districts and one city in central Uganda.

Participants
21 key informants (KIIs) with district leaders, 4 focus group discussions (FGDs) with community health workers (CHWs) termed as village health teams in the Ugandan setting and a survey of 487 CHWs and 419 pregnant women who had childbirth 12 months before.

Study measures
KIIs and FGDs explored community health system resources using the WHO health systems building blocks and the UNICEF health system strengthening maturation model. However, the surveys explored the work-related attributes and services delivered by the CHWs and to the community, respectively.

Analysis
A framework analysis was used for qualitative data in NVivo 14. While descriptive and stratified analyses were conducted for quantitative data in Stata I/C 15.0: proportions for the varied geographical entities were compared using the t-test with p values

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Gennaio 2025