Meeting the recommended guidelines for physical activity (PA), sedentary behaviour (SB) and sleep, collectively referred to as 24-hour movement behaviours (24h-MBs), is crucial for type 2 diabetes mellitus (T2DM) management and is associated with favourable health outcomes. However, it is suggested that adults with T2DM spend more time in SB and less time in PA compared with adults without diabetes.

This study aims to compare 24h-MBs between adults with and without T2DM (ie, controls with similar characteristics except for having T2DM), investigate how this is associated with cardiometabolic health, and assess changes in 24h-MBs after two years of follow-up (FU) in adults with T2DM.

Cross-sectional and longitudinal study.

Community-dwelling adults with T2DM and controls in Belgium.

This study took place between September 2021 and December 2023. The 24h-MBs were measured using accelerometers (Actigraph wGT3X+); cardiometabolic variables (adiposity, blood pressure and advanced glycation end-products) were collected in both groups. In adults with T2DM, fasting blood samples were collected at baseline and second FU. Compositional data analysis was used to explore group differences in 24h-MBs using multivariate analysis of variance, and regression models analysed associations with cardiometabolic health. Changes in 24h-MBs over time in adults with T2DM were assessed using a linear mixed model.

52 adults with T2DM (mean age 63.2 SD 10.6) and 74 controls (mean age 62.7 SD 9.4) were included in the cross-sectional analysis. The 24h-MBs of adults with T2DM differed significantly from the controls (p=0.026). Adults with T2DM spent significantly less time in light (–34.7 min/day) and moderate to vigorous PA (MVPA) (–24.1 min/day) compared with controls. In adults with T2DM, reallocating 30 min from any behaviour to MVPA was associated with a significant increase in high-density lipoprotein-cholesterol (sleep: 5.05 mg/dL (2.45; 7.80), standardised effect size (ES)=0.53; SB: 4.53 mg/dL (1.93; 7.27), ES=0.47; light PA: 5.29 mg/dL (2.07; 8.73), ES=0.55) whereas in the control group significant decreases in waist circumference were found when reallocating 30 min from SB to sleep (2.42 cm (0.86–3.97), ES=0.34). 37 (mean age 65.0 SD 9.5) and 22 (mean age 67.0 SD 7.7) adults with T2DM provided valid data after 1 year and 2 years of FU, respectively. No significant changes in 24h-MBs were found after 1-year (p=0.93) or 2-year (p=0.79) FU among adults with T2DM.

Adults with T2DM have a less favourable 24h-MB composition compared to adults without T2DM, indicating the need for additional effort to achieve and maintain the guidelines. Despite the limited associations found, time reallocations from other behaviours to MVPA theoretically suggest the biggest health benefits.

NCT04993482.

Ventilation tube insertion for paediatric otitis media (POM), including acute otitis media (AOM) and otitis media with effusion (OME), has been signalled in the past for potential unwarranted treatment variation. Quality improvement initiatives, like Audit & Feedback (A&F), often ignore the care pathway when identifying such variation, possibly overestimating variation at a specific care step. To gain more insight into the effect of prior care steps, this study examined (1) the degree of regional variation in each step of the care pathway (general practitioner (GP) contacts, referrals and surgeries) and (2) investigated the effect of adjusting for prior care steps.

Observational study using general practice electronic health record data linked to specialist claims data.

272 790 children ≤12 years with and without POM registered in 320 GP practices between 2017 and 2018.

Using multilevel logistic regression, the degree of regional variation in each step of the POM care pathway was assessed by calculating the coefficient of variation (CV).

The effect of adjusting for prior care steps was determined by estimating correlations between subsequent care steps and analysing the impact on the CV.

Regional variation in POM treatment was larger in each subsequent step in the care pathway (CV POM GP contacts 0.110; referral 0.179; surgery 0.239). In regions with a higher proportion of children with frequent AOM/persistent OME, referral rates were higher (POM: OR: 1.06; 95% CI: 1.02 to 1.11) and surgical rates were higher (for OME only: OR: 1.08; 95% CI: 1.02 to 1.15). Regional variation in referrals and surgery decreased after adjusting for the regional frequent AOM/persistent OME rate (CV referrals POM 0.103 vs 0.128; CV surgery OME 0.047 vs 0.059).

Regional variation is observed in GP contact rates for POM and is larger in referrals and surgeries. Adjusting for the proportion of frequent AOM/persistent OME significantly reduces regional variation in POM treatment. Future A&F should adjust for prior care processes and develop tailored interventions for quality improvement.

To assess atrial fibrillation (AF) burden, symptoms and quality of life (QoL) in endurance athletes with paroxysmal AF.

Prospective cohort study.

Otherwise healthy endurance athletes with paroxysmal AF in Norway, Australia and Belgium. The current study presents baseline measurements collected before the intervention of a randomised controlled trial on effects of individually tailored training adaptation.

AF burden (percentage time in AF) was measured by insertable cardiac monitors (Confirm Rx, Abbott). AF-related symptoms and QoL were assessed using the Atrial Fibrillation Effect on QualiTy-of-Life Questionnaire (AFEQT) with any score

43 athletes (age 57±10 (mean±SD), range 33–75 years, 3 women) were included. The athletes were monitored for 50±18 days. Median AF burden was 0.18% (IQR 0%–2.6%). Out of 29 athletes with at least one AF episode, 21 (72%) had AF episodes >60 min. 13 athletes (30%) had AFEQT overall score 60 min were associated with reduced QoL (mean AFEQT score 78 vs 90, p=0.001 and 78 vs 90, p=0.001, respectively). There were large individual variations between the athletes concerning AF burden, symptoms and QoL.

Although most athletes were still competing, more than half had troublesome symptoms. One-third had reduced QoL, which was associated with higher AF burden and longer duration of AF episodes. Variations between the athletes highlight the need for individually tailored AF management in athletes with paroxysmal AF.

NCT04991337.

For patients with perihilar cholangiocarcinoma (pCCA), surgical resection remains the sole treatment modality that can potentially result in cure. Unfortunately, the majority of patients present with unresectable tumours or are excluded from surgical treatment due to complications like cholangitis affecting their performance status. In the Netherlands, recommended first-line treatment for patients with unresectable pCCA is palliative chemotherapy with gemcitabine and cisplatin. This regimen yields an estimated median overall survival (OS) of 11.7–15.2 months, highlighting the urgent need for novel treatment options. The STRONG I trial, a phase I study in patients with unresectable pCCA, was completed in 2020. Its aim was to assess the feasibility and toxicity profile of adding stereotactic body radiation therapy (SBRT) to chemotherapy. SBRT, delivered in 15 fractions of 4.0 Gray (Gy), was considered to be feasible and safe, with no dose-limiting toxicity being observed. The 1-year local tumour control rate was 80% and the 1-year OS rate 100%, with maintenance of quality of life (QoL). These results encouraged us to initiate the STRONG II trial, aiming to investigate the efficacy of adding SBRT to chemotherapy in a larger patient cohort.

STRONG II is a single-arm, multicentre phase II study. Patients with non-metastatic unresectable pCCA (T1-4, N0-2) are eligible. A total of 30 patients will be enrolled in six academic centres in the Netherlands and two in Belgium. SBRT will be delivered in 15 fractions of 4.0–4.5 Gy. The primary endpoint is local tumour control, defined by Response Evaluation Criteria in Solid Tumours (RECIST) V.1.1. Secondary endpoints include toxicity, biliary stent-related events, progression-free survival, OS and QoL using the EuroQoL five-dimensional, five-level (EQ-5D-5L) questionnaire, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) and the EORTC Biliary Module (QLQ-BIL21). In addition, we will explore the predictive value of the peripheral immunological status (immune-related proteins and serum functional immunological status assay) and its dynamics in determining survival outcomes. For this explorative translational study, two blood samples will be collected, one before the start of chemotherapy and another after completing chemotherapy.

Approval of the study was obtained on 5 June 2024 by the Medical Ethics Review Committee of Erasmus Medical Center Rotterdam, the Netherlands (ID: NL86210.078.24). The anticipated time frame for patient enrolment is July 2024 to December 2027. The main study findings will be published in peer-reviewed medical journals, and presented at national and international conferences.

NCT06493734 (ClinicalTrials.gov).