This study aimed to investigate the association between smoking behaviours during early pregnancy and the risk and severity of gestational diabetes mellitus (GDM), with a particular focus on smoking status, smoking intensity and secondhand smoke exposure.

Secondary analysis of prospectively collected cohort data.

Multi-centre study conducted in South Korea (Korean Pregnancy Outcome Study) between March 2013 and January 2017.

From 4537 pregnant women initially enrolled, 3457 singleton pregnancies were included after excluding cases with transfer, loss to follow-up, twin pregnancies, miscarriages and pre-existing diabetes mellitus. All participants were women of Korean ethnicity.

Primary outcome was GDM and its subtypes (A1GDM: diet-controlled; A2GDM: insulin-requiring). Secondary outcomes were associations with active smoking (before pregnancy and during early pregnancy), smoking intensity dose–response relationships (pack-years) and secondhand smoke exposure among never-smokers.

Among 3457 participants, 231 women (6.7%) were diagnosed with GDM (198 A1GDM, 33 A2GDM). Active smoking before pregnancy (adjusted OR (aOR) 3.98, 95% CI 1.58 to 9.30) and during early pregnancy (aOR 9.90, 95% CI 2.97 to 29.45) were significantly associated with A2GDM, while no significant association was observed with A1GDM. A clear dose-response relationship was observed, with smoking intensity >4 pack-years markedly increasing A2GDM risk (aOR 20.68, 95% CI 6.75 to 59.39). Detailed pack-year analysis showed 4–6 pack-years (aOR 20.57, 95% CI 5.80 to 65.46) and >6 pack-years (aOR 25.98, 95% CI 3.21 to 146.45). Among never-smokers, secondhand smoke exposure showed a borderline association with overall GDM risk (aOR 1.33, 95% CI 0.98 to 1.81).

Maternal active smoking before and during early pregnancy, as well as higher smoking intensity, was associated with an increased risk of pharmacologically treated GDM (A2GDM). Although secondhand smoke exposure did not reach statistical significance, the trend suggested a potential association with GDM risk among never-smokers. These findings provide important evidence for public health strategies for prenatal care, as smoking cessation and environmental smoke avoidance during prenatal and early antenatal care in women reduce the risk of gestational diabetes.

Type 2 diabetes mellitus has been associated with an increased risk of cognitive decline and dementia, with patients being 1.5–2 times more likely to develop these conditions. While both sodium-glucose co-transporter 2 (SGLT2) inhibitors and thiazolidinediones (TZDs) have shown potential neuroprotective effects in previous studies, their comparative effectiveness for preventing neurodegenerative outcomes has not been established. This study aimed to compare the risk of stroke, dementia and Alzheimer’s disease (AD) between patients treated with SGLT2 inhibitors and those treated with TZDs.

Multicentre, retrospective, observational, new-user, active-comparator cohort study.

Electronic health record-based databases from 11 secondary and tertiary institutions in South Korea from 1 January 2014 to 31 July 2025. The study period began in 2014, following the post-marketing surveillance initiation of SGLT2 inhibitors in Korea (November 2013), to ensure adequate drug availability and clinical adoption.

Patients aged 40 years or older who were newly prescribed either SGLT2 inhibitors or TZDs without prior exposure.

Propensity score matching (1:1) was performed using sex as the primary covariate due to data availability constraints in the Observational Medical Outcomes Partnership Common Data Model framework. The HRs with 95% CIs were measured via Cox regression analysis.

The study analysed 24 172 matched pairs for stroke outcomes (40 483 person-years in the SGLT2 inhibitor group and 39 363 person-years in the TZD group), 25 111 matched pairs for dementia (41 924 person-years in the SGLT2 inhibitor group and 40 726 person-years in the TZD group) and 25 237 matched pairs for AD (42 139 person-years in the SGLT2 inhibitor group and 40 895 person-years in the TZD group) across 11 participating hospitals. After a 1:1 propensity score matching, the SGLT2 inhibitors showed no significant difference in stroke risk (HR 1.18, 95% CI 0.62 to 2.23, p=0.62), while having significant reductions in dementia risk (HR 0.66, 95% CI 0.45 to 0.98, p=0.04) and AD risk (HR 0.54, 95% CI 0.35 to 0.83, p=0.005). Moreover, these protective effects for neurodegenerative outcomes were shown to be consistent across multiple hospital sites.

SGLT2 inhibitors are associated with a reduced risk of dementia and AD compared with TZDs in patients aged 40 years or older with type 2 diabetes and have neutral effects on stroke risk. These findings confirm the potential selective neuroprotective benefits of SGLT2 inhibitors for neurodegenerative outcomes, which may inform therapeutic decision-making for diabetic patients at risk of cognitive decline.

People with serious mental illness (SMI) can experience significant physical health challenges. The Health Champions intervention was developed to support their physical health through using trained volunteers. However, volunteer and patient perspectives on the impact and implementation of this intervention have yet to be understood.

To compare the views of patients and volunteers on the Health Champions intervention.

A qualitative thematic analysis was conducted on interviews with 29 study participants. Interviews were carried out either face-to-face, via Microsoft Teams, or by telephone and included 12 patients (6 men and 6 women) and 17 volunteers (the Health Champions) (5 men and 12 women).

Four overarching themes were identified, highlighting both similarities and differences between stakeholders’ perspectives: (1) supporting goal setting; (2) impact on positive lifestyle; (3) experiences and perception of the programme and (4) navigating challenges during the programme. Both groups found the programme to be largely successful, by motivating patients to work towards their physical health goals and facilitating successful matching of patients with volunteers. Volunteers and patients valued good communication with the research team. Though both groups shared some views on the challenges with scheduling and a lack of face-to-face contact during the COVID-19 pandemic, their perceptions on how patients incorporated their health changes during and after the programme, as well as other administrative concerns such as views on the efficacy of journaling and breakdown of roles, differed.

The Health Champions intervention was perceived as useful to improve the physical health of patients with SMI. Differences in the views between the two stakeholders may result from their distinct experiences and expectations. Future volunteering programmes should further support the diverse physical health needs of patients with SMI.

Concentration of care and collaborations between hospitals increasingly reorganise oncological care into Comprehensive Cancer Networks (CCNs), aiming to improve care outcomes and reduce costs. This study aims to evaluate the effect of four CCNs on healthcare cost and outcomes for patients with colon or pancreatic cancer.

We performed a retrospective cohort study based on claims data in the Netherlands. Data included patient characteristics, health insurance claims and healthcare activities. All costs were indexed to Euro 2023. We performed propensity score matching per CCN and applied regression models with a difference-in-difference design, adjusting for non-linear trends before the start of a CCN.

The study was conducted within the Dutch healthcare system, analysing claims data representative of hospital-based cancer care.

A total of 92 309 patients with colon cancer and 25 630 patients with pancreatic cancer were included. Patients were identified through health insurance claims between January 2013 and June 2021.

Implementation of four CCNs, which included structured collaboration between healthcare organisations. Follow-up duration was 2 years post-diagnosis.

Primary outcomes included 2-year oncological healthcare costs and 2-year mortality rate. Secondary outcomes involved care process indicators: referral rates and double diagnostics (an identical diagnostic activity performed within 4 weeks after referral to a secondary hospital).

For colon cancer, one CCN showed a significant decrease in 2-year oncological costs (–1899). One CCN showed a significant decrease in referrals (–3.6%) and one a significant increase (+4.4%). No significant effect on 2-year mortality and double diagnostic activities was found. For pancreatic cancer, one CCN showed a significant decrease in 2-year oncological costs (–3747) and one CCN showed a significant increase in double diagnostic activities (+8.6%). No significant effect on referrals and 2-year mortality was found.

CCNs do not consistently reduce costs or affect referral patterns or redundant diagnostics. No impact on mortality was found. Additional insights into determinants of CCN success are required before broad implementation is warranted.

To develop and externally validate a two-stage machine learning framework that integrates polygenic risk and clinical variables for early identification of individuals at risk of developing type 2 diabetes.

We conducted a prospective prediction study using data from the All of Us Research Program for model development and the UK Biobank for external validation. Two models were constructed. Stage 1 used gradient boosted decision trees (XGBoost) with cross validation, automated hyperparameter optimisation and class weighting to predict 5-year incident type 2 diabetes using demographic, clinical and polygenic predictors. Stage 2 incorporated glycated haemoglobin or fasting glucose measurements to refine risk estimates. Model interpretation used SHapley Additive exPlanations values and permutation importance, and logistic regression and random forest models served as comparators. Discrimination of all models was compared using the DeLong test.

The Stage 1 model achieved an area under the receiver operating characteristic curve (AUROC) of 0.81 in All of Us and 0.82 in UK Biobank, performing significantly better than the phenotype-only model in UK Biobank (DeLong p=1.05x10^–⁷⁶). Higher polygenic risk quartiles were associated with increased incidence of type 2 diabetes in both cohorts (global ² p

A two-stage machine learning framework that integrates genetic and clinical information can support personalised screening for type 2 diabetes across diverse populations. The approach demonstrated robust performance across cohorts and offers a practical structure for early risk identification.

This study aimed to examine adverse event occurrences in outpatient care settings and healthcare utilisation after discharge and to identify the characteristics of patients at high risk of safety issues during the care transition from the hospital to their homes. In addition, the performance of outpatient triggers for the detection of adverse events was explored.

A retrospective cohort study using hospital medical record reviews over 6 months postdischarge.

A tertiary teaching hospital in South Korea.

A total of 746 adult patient medical records mainly including patients potentially at high risk of adverse events were analysed, comprising 5439 outpatient visits.

Occurrence of adverse events.

Approximately 14.2% of patients experienced at least one adverse event within 6 months postdischarge. Medication-related (84.2%) and surgical/procedural (13.2%) events were common. Most events were mild in severity and assessed as unpreventable. Patients who experienced adverse events had significantly more all-cause re-hospitalisations, emergency room visits and outpatient clinic visits. No difference was found in mortality. Controlling for other variables, multiple logistic regression analysis showed that patients who are overweight (OR=0.48, 95% CI 0.25 to 0.90), with circulatory system diseases (OR=0.38, 95% CI 0.15 to 0.96) and with a National Early Warning Score 2 (NEWS2) ≥2 at discharge (OR=0.26, 95% CI 0.12 to 0.54) were less likely to experience adverse events. Those with admissions via emergency rooms or day-surgery centres (OR=1.98, 95% CI 1.18 to 3.32), in medical departments (OR=1.93, 95% CI 1.15 to 3.23), with a diagnosis of cancer (OR=2.03, 95% CI 1.14 to 3.62) and longer hospital stays (OR=1.07, 95% CI 1.02 to 1.11) were more likely to experience adverse events postdischarge. Outpatient triggers with relatively high performance included ‘constipation with narcotics/calcium channel blockers’, ‘abrupt medication discontinuation’, ‘rash’ and ‘white blood cell count 3’.

Approximately 14% of patients, mainly comprising high-risk patients, experienced adverse events postdischarge, with more emergency room visits and all-cause re-hospitalisations. Patients experiencing adverse events were characterised by body mass index, type of admission route, clinical department, medical diagnosis, length of hospital stay and NEWS2. Patient and caregiver participation in the monitoring and reporting of adverse events should be encouraged to improve postdischarge patient safety. The use of triggers to detect potential patient safety problems is recommended.

Post-COVID syndrome manifests with a diverse array of symptoms for which no standard care plan currently exists. Many questions were raised by patients, which underscored the need for a validated patient-reported outcome measure (PROM). Therefore, a post-COVID module was developed to be included in the Assessment of Burden of Chronic Conditions (ABCC-) tool. The ABCC-tool evaluates and visualises the perceived physical, emotional and social burden of one or multiple chronic disease(s) using a balloon diagram and aims to facilitate person-centred care and structured discussions between patients and healthcare professionals. This study explores the patients’ perspective on the content of the ABCC-tool for post-COVID and the tool’s usability in a home-based setting.

All patients who completed the ABCC-tool for post-COVID were invited for an online semi-structured interview. We selected post-COVID patients who had used the tool in the past three months. Interviews were audio recorded and analysed using a thematic approach with Atlas.ti version 23.

Nineteen post-COVID patients (10 males, mean age 56) were interviewed between May and August 2024. The tool was regarded as user-friendly, and patients indicated they would use the tool again in the future. Patients valued the tool’s broad range of topics, some of which are often overlooked in standard healthcare consultations. The tool was comprehensible and relevant according to all patients. The balloon diagram was easy to understand, but a legend explaining the colours of the balloons was preferred. Other suggestions for improvement included adding open-text fields and periodic reminders to increase usability and adding long-term data.

The ABCC-tool is a promising instrument for post-COVID patients, offering a structured way to monitor and communicate experienced burden in addition to standard healthcare consultations. Refinements addressing usability and comprehensiveness are recommended to facilitate its integration into clinical practices.

To investigate the attitudes of physicians towards addressing environmental sustainability in patient conversations, and to identify barriers and facilitators to doing so.

A qualitative, nation-wide study was conducted using semi-structured online focus groups and interviews. Reflexive thematic analysis was used to analyse transcripts, guided by the Theoretical Domains Framework.

Secondary and tertiary healthcare institutions in the Netherlands.

Participants were medical specialists and residents in obstetrics and gynaecology (OB-GYN physicians) in the Netherlands. Participants were purposefully identified to capture diverse demographics and practice settings.

Physicians’ attitudes towards discussing the environmental impact of healthcare and the health effects of environmental pollution with patients. Themes were identified and categorised using the Theoretical Domains Framework.

The study included 28 OB-GYN physicians working across 23 healthcare institutions in the Netherlands. Six themes were developed: (1) strong sense of urgency to reduce healthcare's environmental impact, (2) knowledge gaps impair communication about environmental impact to patients, (3) prioritisation of individual patient health over environmental concerns in decision-making, (4) perceived lack of patient interest in environmental outcomes, (5) system-level support facilitates discussions about environmental sustainability with patients and (6) limited perceived value in discussing the health effects of environmental pollution and climate change with patients.

OB-GYN physicians are supportive of discussing the environmental impact of healthcare services when clinically appropriate. Addressing knowledge gaps, providing evidence-based guidance and embedding sustainability into clinical guidelines and decision aids may facilitate the integration of environmental sustainability into patient-provider interactions.

Post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) is associated with future major adverse cardiac events and may reflect residual ischaemia and suboptimal stent result (SSR). Post-PCI FFR should therefore be considered to identify patients at high risk. Whether abnormal post-PCI FFR and non-hyperaemic pressure ratios, including resting full-cycle ratio (RFR), represent SSR after PCI remains to be determined, especially after chronic total occlusion (CTO) PCI. In addition, little is known about the association between post-PCI intracoronary physiology and SSR with residual anginal complaints.

The physioLogy to evaluaTe procedural Result After percutaneous coronary intervention of Chronic Total Occlusion study is a prospective, multicentre, exploratory, mechanistic, investigator-initiated, single-arm study with a non-inferiority design. A total of 200 patients, undergoing CTO PCI, with FFR and RFR measured in all patients, will be included at two study sites in the Netherlands. The primary endpoint is the area under the curve (AUC) of post-PCI RFR, in comparison to the AUC of post-PCI FFR, for prediction of optical coherence tomography-detected SSR and its individual components.

The study is approved by the local ethical review board (‘Medisch Ethische Toetsing Commissie Isala Zwolle’). Written informed consent will be obtained from all patients before enrolment. The outcomes of this study are intended to be disseminated in a peer-reviewed journal.

NCT04780971.

Value-based healthcare (VBHC) strives to improve the healthcare system by focusing on value of care, that is, patient relevant outcomes relative to the costs for achieving these outcomes. Within VBHC, patient participation is crucial to identify patient relevant outcomes and value improvement potential. However, patient participation in VBHC initiatives remains limited. Therefore, we aimed to improve patient participation within VBHC teams with the ultimate aim to develop a practical guide for patient participation in VBHC.

An action research study.

This study was conducted in seven collaborating Dutch hospitals from March 2023 to November 2024.

Seven VBHC teams were selected to participate in the cyclical action research steps, that is, orientation, planning, implementation, and evaluation, in which patient participation was implemented or improved. These included the following patient groups: prostate cancer, vulnerable elderly, breast cancer, diabetes, maternity care, colorectal cancer and chronic kidney disease.

Both qualitative and quantitative data were collected. Qualitative data included observations and minutes of meetings with the intervention teams. Quantitative data included responses to the Public and Patient Engagement Evaluation Tool (PPEET) by multiple members of the intervention (n=7) and control teams (n=94) at three time points (T1=6 months, T2=12 months, T3=end of study). Qualitative data were thematically analysed and quantitative data were analysed descriptively. Finally, the data were triangulated to create an overview of lessons learnt in improving patient participation.

Patient participation goals varied across teams, leading to diverse actions, such as establishing a diabetes patient panel and distributing questionnaires to patients with colorectal cancer. PPEET results show that 71% of intervention team members reported that patient participation had an impact on the team’s outcomes compared with 44% in control teams (T3). Furthermore, 80% of the intervention team members initially wanted training in patient participation (T1), which dropped to 29% at T3. Overall, 22 lessons in improving patient participation in multidisciplinary project teams were identified and compiled into a practical guide.

The action research process improved the process and impact of patient participation in the intervention teams. Furthermore, the results indicate that the action research process enhanced the team members’ knowledge and skills on patient participation. The practical guide developed in this study can be used to support implementation of patient participation in VBHC.

To assess the association of normal systolic blood pressure maintenance (SBP_maintain) with coronary artery calcification (CAC) progression in non-diabetic and diabetic subjects at low to intermediate cardiovascular risk.

Retrospective cohort study with a mean follow-up of 3.3 years.

Data from the Korea Initiatives on Coronary Artery Calcification registry were analysed.

10 754 asymptomatic Korean adults (51.5±8.6 years; 84.5% male; 14.2% diabetes) were enrolled. Participants were divided into two groups: normal SBP_maintain (maintain (≥120 mmHg) at the time of follow-up CAC scan.

CAC progression was defined as a difference of ≥2.5 between the square roots () of the baseline and follow-up coronary artery calcium score (CACS) (transformed CACS). Annualised transformed CACS was defined as transformed CACS divided by the interscan period.

Compared with non-diabetics, the incidence of CAC progression was higher in diabetics (28.4% vs 47.3%, pmaintain was inversely associated with an annualised transformed CACS (β: –0.18, 95% CI: –0.25 to –0.12, pmaintain showed a lower risk of CAC progression than ≥elevated SBP_maintain in non-diabetics; however, this association was not observed in patients with diabetes.

Maintaining normal systolic blood pressure was associated with a significantly attenuated CAC progression, especially in clinical conditions without established diabetes.

To explore the association between the degree of coronary artery calcium (CAC) and the progression of calcific aortic valve disease (CAVD).

A single-centre retrospective cohort study using a hospital-based database.

A total of 2898 patients who underwent coronary CT angiography and serial echocardiograms at ≥6 months apart were included. Initial echocardiography was performed within 6 months from the time of CCTA.

CAC was divided into four groups: 0, 1–99, 100–399 and ≥400 (Agatston units, AU). The progression of CAVD was defined in two ways: progression 1 as at least one grade of progression, progression 2 as at least moderate aortic stenosis (AS) at follow-up.

At the initial CAVD grade, patients with at least mild AS tended to increase with increasing CAC (p

CAC was significantly associated with the progression of CAVD. Particularly, CAC≥400 was linked to progression toward significant AS.

To examine trends in preconception and pregnancy cardiometabolic risk factors and conditions, pregnancy and birth complications, obstetric interventions, and the impact of COVID-19, and to forecast future disease burden.

A multi-centre retrospective cohort study.

A large hospital network with three maternity hospitals serving ethnically diverse populations in Melbourne, Australia.

Pregnant women who gave birth between 2016 and 2022.

Trends in cardiometabolic conditions, birth complications and obstetric interventions.

Over 7 years, 63 232 women were included, of whom 40% were nulliparous, and 60.9% were born overseas from 167 countries. From 2016–2022, maternal age (30.2–31.3 years), obesity (21.0%–26.2%), gestational diabetes mellitus (GDM) (15.9%–28.1%) and caesarean delivery (28.5%–37.6%) increased, while average gestational weight gain, premature births and special care admissions declined from 12.6–11.6 kg, 6.3%–4.9% and 24.2%–14.1%, respectively; and was statistically significant (p

Prepregnancy and pregnancy cardiometabolic risk factors and conditions, pregnancy and birth complications, and obstetric interventions increased markedly over 7 years. Despite this, offspring complications, including special care admissions, stillbirths and prematurity, decreased, while pregnancy complications peaked during COVID-19. GDM is forecasted to increase to 43.0% by 2028, posing an unsustainable health and economic burden that necessitates urgent public health initiatives.

To develop, evaluate and validate the musculoskeletal health climate questionnaire (MHCQ), a multidimensional questionnaire for measuring musculoskeletal health climate.

Cross-sectional test–retest study including systematic scale development and psychometric validation.

The questionnaire was developed following the best practice recommendations for scale development outlined by Boateng et al (2017), including item development, scale development and scale evaluation with input from experts, stakeholders and the target population. Validation was conducted among employees in three physically demanding occupations in Denmark (care workers, slaughterhouse workers and residential painters), where a total of 1420 participants were recruited through labour unions. Of these, 796 completed the retest survey 30 days later. Exploratory and confirmatory factor analyses (EFA and CFA, respectively), internal consistency (Cronbach’s α), test–retest reliability (intraclass correlation coefficients (ICC)) and SEM were used to assess the psychometric properties. Criterion validity was examined via associations with pain points, pain medication use and sickness absence. Construct validity was assessed using correlations with the prevent for work questionnaire (P4Wq).

EFA and CFA supported a four-factor model (supervisor’s practices, workplace practices, worker involvement practices and workers’ pain practices) with good to excellent fit (comparative fit index, 0.96–0.99; root mean square error of approximation, 0.04–0.06). All scales showed high internal consistency (α=0.80–0.88) and excellent test–retest reliability (ICC=0.86–0.92). Associations with musculoskeletal outcomes supported criterion validity. Weak to moderate correlations with the P4Wq subscales (rho

The MHCQ provides a validated, multidimensional tool to assess workplace climate related to musculoskeletal health. It can support workplace assessments and prevention efforts by capturing shared perceptions of leadership, support, involvement and pain-related norms. Further longitudinal research and the use of objective outcome data are needed to assess predictive validity and strengthen the instrument’s applicability across settings.

In 2022, the WHO conditionally recommended the use of treatment decision algorithms (TDAs) for treatment decision-making in children

Within the Decide-TB project (PACT ID: PACTR202407866544155, 23 July 2024), we aim to generate an individual-participant dataset (IPD) from prospective TB diagnostic accuracy cohorts (RaPaed-TB, UMOYA and two cohorts from TB-Speed). Using the IPD, we aim to: (1) assess the diagnostic accuracy of published TDAs using a set of consensus case definitions produced by the National Institute of Health as reference standard (confirmed and unconfirmed vs unlikely TB); (2) evaluate the added value of novel tools (including biomarkers and artificial intelligence-interpreted radiology) in the existing TDAs; (3) generate an artificial population, modelling the target population of children eligible for WHO-endorsed TDAs presenting at primary and secondary healthcare levels and assess the diagnostic accuracy of published TDAs and (4) identify clinical predictors of radiological disease severity in children from the study population of children with presumptive TB.

This study will externally validate the first data-driven WHO TDAs in a large, well-characterised and diverse paediatric IPD derived from four large paediatric cohorts of children investigated for TB. The study has received ethical clearance for sharing secondary deidentified data from the ethics committees of the parent studies (RaPaed-TB, UMOYA and TB Speed) and as the aims of this study were part of the parent studies’ protocols, a separate approval was not necessary. Study findings will be published in peer-reviewed journals and disseminated at local, regional and international scientific meetings and conferences. This database will serve as a catalyst for the assessment of the inclusion of novel tools and the generation of an artificial population to simulate the impact of novel diagnostic pathways for TB in children at lower levels of healthcare. TDAs have the potential to close the diagnostic gap in childhood TB. Further finetuning of the currently available algorithms will facilitate this and improve access to care.

Given that low retention rates are a prevalent challenge in clinical trials, which ultimately affects trial validity, it is recommended that interventions be developed and evaluated to increase trial retention. In the context of trial retention, incorporating behavioural science is endorsed, as it provides a theoretical foundation for considering human behaviour. We hypothesised that an intervention informed by self-determination theory could increase retention in a randomised allergy trial on intralymphatic immunotherapy, as the support of basic psychological needs for autonomy, competence and relatedness is anticipated to lead to more sustained engagement and better outcomes.

To assess the acceptability and feasibility of the intervention and evaluation design, following the complex intervention framework by the Medical Research Council, before proceeding to a randomised evaluation.

A parallel two-arm randomised feasibility study was conducted within the randomised allergy trial.

All participants at one Danish site were eligible for recruitment.

The intervention was a web app informed by self-determination theory to support the basic psychological needs through its thoughtfully designed features. Participants were allocated unblinded across treatment groups to complete daily online questionnaires over a 100-day period from May to August 2022. All participants received a daily text message with a link for the questionnaires. On completion, participants in the control group received a confirmation message, while participants in the intervention group had a browser with the menu of the web app opened for them. The features within the menu were voluntary to use.

The prespecified assessments included evaluating the recruitment rate, retention rate (which reflected both sustained participation and the proportion of completed daily questionnaire entries), the suitability of outcome measures and the acceptability of the intervention and evaluation design to both participants and staff. Qualitative data were collected through a collaborative learning process with participants from the intervention group in November 2022.

A total of 30 participants were invited, randomly assigned 1:1 and analysed, resulting in a recruitment rate of 100%. None were lost to follow-up as all remained in the study for the entire duration. The response rate was 84.5% in the intervention group and 79.1% in the control group, indicating satisfactory retention. Outcome measures were deemed appropriate. No unintended adverse events were identified. The collaborative learning meetings involved three participants in the first meeting and two in the second, comprising a total of five different individuals. Participants found the intervention acceptable. They used it differently but agreed that its components were useful. Technical issues needed fixing, and voluntary free text boxes and registration of medication dosage should be added.

The intervention and evaluation design were assessed as acceptable and feasible. Technical issues were fixed, and additional response options were added before a randomised evaluation.

ILIT.NU: EudraCT 2020-001060-28. ClinicalTrials.gov NCT05191186.

Women with gestational diabetes mellitus (GDM) are at seven-fold to ten-fold increased risk of type 2 diabetes mellitus (T2DM) when compared with those who experience a normoglycaemic pregnancy, and the cumulative incidence increases with the time of follow-up post birth. This protocol outlines the development and validation of a risk prediction model assessing the 5-year and 10-year risk of T2DM in women with a prior GDM diagnosis.

Data from all birth mothers and registered births in Victoria and South Australia, retrospectively linked to national diabetes data and pathology laboratory data from 2008 to 2021, will be used for model development and validation of GDM to T2DM conversion. Candidate predictors will be selected considering existing literature, clinical significance and statistical association, including age, body mass index, parity, ethnicity, history of recurrent GDM, family history of T2DM and antenatal and postnatal glucose levels. Traditional statistical methods and machine learning algorithms will explore the best-performing and easily applicable prediction models. We will consider bootstrapping or K-fold cross-validation for internal model validation. If computationally difficult due to the expected large sample size, we will consider developing the model using 80% of available data and evaluating using a 20% random subset. We will consider external or temporal validation of the prediction model based on the availability of data. The prediction model’s performance will be assessed by using discrimination (area under the receiver operating characteristic curve, calibration (calibration slope, calibration intercept, calibration-in-the-large and observed-to-expected ratio), model overall fit (Brier score and Cox-Snell R2) and net benefit (decision curve analysis). To examine algorithm equity, the model’s predictive performance across ethnic groups and parity will be analysed. Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis-Artificial Intelligence (TRIPOD+AI) statements will be followed.

Ethics approvals have been received from Deakin University Human Research Ethics Committee (2021–179); Monash Health Human Research Ethics Committee (RES-22-0000-048A); the Australian Institute of Health and Welfare (EO2022/5/1369); the Aboriginal Health Research Ethics Committee of South Australia (SA) (04-23-1056); in addition to a Site-Specific Assessment to cover the involvement of the Preventative Health SA (formerly Wellbeing SA) (2023/SSA00065). Project findings will be disseminated in peer-reviewed journals and at scientific conferences and provided to relevant stakeholders to enable the translation of research findings into population health programmes and health policy.

Infertility resulting from cancer treatment is known to be a major factor that reduces the quality of life of young cancer survivors. However, discussions and decision-making about fertility preservation before cancer treatment have been insufficient owing to barriers in the clinical field. In addition, selecting a fertility preservation option requires a complex decision-making process that considers not only medical information but also the patient’s values and preferences. Hence, an environment that more easily supports patient decision-making about fertility preservation needs to be created. Therefore, this protocol will develop and test a web-based decision aid (DA) for fertility preservation among young patients with cancer, considering patient preferences and values, evaluate acceptability and usability of the developed DA and assess its effectiveness.

This protocol outlines the development of a web-based DA for fertility preservation targeting females of reproductive age diagnosed with cancer. It includes alpha testing to evaluate the usability and acceptability of the DA, as well as beta testing to assess its effectiveness outside of clinical settings, both based on an online survey. The web-based DA for fertility preservation consists of three modules: 1) an information collection module, 2) an option suggestion module and 3) a value communication module. The information collection module collects information essential to select appropriate fertility preservation options. The option suggestion module returns all applicable fertility preservation options based on the patient’s characteristics, which are essential for determining the appropriate option, such as menarche status and desire for pregnancy. The value communication module provides information on the extent to which each fertility preservation option satisfies the patient’s values and preferences. After the development of the DA, a small group of young patients with cancer (n=10) and health providers (n=5) will be asked to use this web-based DA for fertility preservation and assess the acceptability and usability of this DA based on a survey (alpha-testing). By reflecting the feedback of acceptability and usability testing, the DA will be updated for improvement, and clinical field testing (beta-testing pilot trial) will be performed using the updated DA. Beta-testing will be conducted on young patients with cancer (aged 18–40 years) before they receive any curative cancer treatment (n=32). These patients with cancer will be randomly allocated to the DA group (intervention group) or the usual care group (control group). The DA group will use the web-based DA before treatment, and the control group will not have access to the web-based DA and will be asked to decide whether to consult a fertility preservation specialist. The primary outcome of the beta testing will be the level of decisional conflict, and the secondary outcomes will include knowledge, decision self-efficacy, decision readiness, depression severity, quality of life, counselling on fertility preservation and decision-making about fertility preservation. Outcomes, including decisional conflict, knowledge, decision self-efficacy, quality of life and depression severity, will be measured before the intervention (T0), 1 week after the intervention (T1) and 1 month after the intervention (T2). The readiness for decision-making will be assessed at T1 for the intervention group only. Counselling on fertility preservation and decision-making about fertility preservation will be assessed once after testing (T2) for both the intervention and control groups.

The study will be conducted in accordance with ethical standards and was approved by the Institutional Review Board at the National Cancer Centre, Korea (IRB No. NCC2024-0050). All study participants will provide written informed consent before participation. The results generated from this study will be presented at conferences or scientific meetings and disseminated through publication in a peer-reviewed journal.

NCT07038174 (beta-testing phase).

Diagnosing pulmonary tuberculosis (PTB) in children is challenging owing to paucibacillary disease, non-specific symptoms and signs and challenges in microbiological confirmation. Chest X-ray (CXR) interpretation is fundamental for diagnosis and classifying disease as severe or non-severe. In adults with PTB, there is substantial evidence showing the usefulness of artificial intelligence (AI) in CXR interpretation, but very limited data exist in children.

A prospective two-stage study of children with presumed PTB in three sites (one in South Africa and two in Pakistan) will be conducted. In stage I, eligible children will be enrolled and comprehensively investigated for PTB. A CXR radiological reference standard (RRS) will be established by an expert panel of blinded radiologists. CXRs will be classified into those with findings consistent with PTB or not based on RRS. Cases will be classified as confirmed, unconfirmed or unlikely PTB according to National Institutes of Health definitions. Data from 300 confirmed and unconfirmed PTB cases and 250 unlikely PTB cases will be collected. An AI-CXR algorithm (qXR) will be used to process CXRs. The primary endpoint will be sensitivity and specificity of AI to detect confirmed and unconfirmed PTB cases (composite reference standard); a secondary endpoint will be evaluated for confirmed PTB cases (microbiological reference standard). In stage II, a multi-reader multi-case study using a cross-over design will be conducted with 16 readers and 350 CXRs to assess the usefulness of AI-assisted CXR interpretation for readers (clinicians and radiologists). The primary endpoint will be the difference in the area under the receiver operating characteristic curve of readers with and without AI assistance in correctly classifying CXRs as per RRS.

The study has been approved by a local institutional ethics committee at each site. Results will be published in academic journals and presented at conferences. Data will be made available as an open-source database.

PACTR202502517486411