There are substantial barriers to initiate advance care planning (ACP) for persons with chronic-progressive disease in primary care settings. Some challenges may be disease-specific, such as communicating in case of cognitive impairment. This study assessed and compared the initiation of ACP in primary care with persons with dementia, Parkinson’s disease, cancer, organ failure and stroke.

Longitudinal study linking data from a database of Dutch general practices’ electronic health records with national administrative databases managed by Statistics Netherlands.

Data from general practice records of 199 034 community-dwelling persons with chronic-progressive disease diagnosed between 2008 and 2016.

Incidence rate ratio (IRR) of recorded ACP planning conversations per 1000 person-years in persons with a diagnosis of dementia, Parkinson’s disease, organ failure, cancer or stroke, compared with persons without the particular diagnosis. Poisson regression and competing risk analysis were performed, adjusted for age, gender, migration background, living situation, frailty index and income, also for disease subsamples.

In adjusted analyses, the rate of first ACP conversation for persons with organ failure was the lowest (IRR 0.70 (95% CI 0.68 to 0.73)). Persons with cancer had the highest rate (IRR 1.75 (95% CI 1.68 to 1.83)). Within the subsample of persons with organ failure, the subsample of persons with dementia and the subsample of stroke, a comorbid diagnosis of cancer increased the probability of ACP. Further, for those with organ failure or cancer, comorbid dementia decreased the probability of ACP.

Considering the complexity of initiating ACP for persons with organ failure or dementia, general practitioners should prioritise offering it to them and their family caregivers. Policy initiatives should stimulate the implementation of ACP for people with chronic-progressive disease.

A thoracic aortic aneurysm (TAA) is often considered a precursor to an acute type A aortic dissection (ATAAD), a life-threatening condition requiring immediate surgical intervention. While both conditions share histopathological similarities, less is known about their overlap in clinical cardiovascular risk factors. This study aimed to map the cardiovascular disease burden in patients with ATAAD and compare it with patients with TAA.

A multicentre retrospective study.

The data were collected from electronic health records of two academic hospitals located in the Netherlands.

Patients who were treated surgically for ATAAD or TAA between 2000 and 2022 were eligible. This study included 731 patients with ATAAD and 480 patients with TAA.

Hypertension was equally prevalent in both groups (50.9% vs 50.6%, p=0.921). Diabetes was uncommon (3.3% vs 6.7%, p=0.638). Hyperlipidaemia (9.6% vs 20.0%, p=0.001) and peripheral arterial disease (8.8% vs 22.7%, p

This study suggests distinct cardiovascular risk profiles in patients with ATAAD and patients with TAA, highlighting the importance of tailored treatment strategies for aortic disease. Further research is needed to investigate the pathophysiological mechanisms underlying these differences and their impact on thoracic aortopathy.

To provide bottom-up guidance on improving post-COVID care using patients’ experiences with received care and their perceived health

Qualitative study design using focus group interviews

30 patients with post-COVID condition recruited through purposive sampling based on patient complexity and diversity

Three dimensions for potential improvements of post-COVID care were identified: (1) building, supporting and maintaining patient resilience, (2) redesigning healthcare pathways to meet patient needs and (3) embedding post-COVID care in health systems and organisations. A conceptual framework that could guide improvements in post-COVID care was developed.

This study revealed several opportunities for improving and implementing post-COVID care following a person-centred approach in multidisciplinary integrated care pathways with an integrative vision of health.

To investigate the prognostic value of the Subgroups for Targeted Treatment (STarT) Screening Tool adapted for concussion (STarT-C) on persistent symptoms and disability at 6–9 months following mild traumatic brain injury (mTBI).

Secondary analysis of two prospective studies: an observational cohort study in New Zealand and usual care control arm of a clinical trial in Canada (ClinicalTrials.gov Registry (NCT04704037)).

Participants in the New Zealand cohort were recruited from concussion clinics (five sites) and those in the Canadian cohort were recruited from emergency departments/urgent care centres (eight sites).

New Zealand participants (n=93, median age 37 years, 60% women) were assessed at median=6 weeks post-injury (T1) and 6 months later (T2). Canadian participants (n=223, median age 38 years, 56% women) were assessed at median=2 weeks (T1) and 6 months later (T2).

Symptoms at T2 were assessed using the validated Rivermead Postconcussion Symptoms Questionnaire (RPQ) and disability using the WHO Disability Assessment Schedule 2.0 12-item Interview.

In linear regression analyses, the STarT-C predicted symptom burden (R²=18–36%) and disability (R²=15–18%) at T2 in both cohorts. While the additional prognostic value over and above baseline variables was substantial (delta R² 8–40%), the additional prognostic value over the RPQ at T1 was variable and generally lower (delta R²=1–9%).

The STarT-C—a brief screening tool—predicted persistent symptoms and disability in adults following mTBI. The incremental prognostic value of the STarT-C over the RPQ may be variable, but regardless, the tool may be useful for identifying those at risk of prolonged recovery who may benefit from early psychological intervention.

Our aim is to develop a Framework of Measurement for people living with Long COVID and their caregivers for use in Long COVID research and clinical practice. Specifically, we will characterise evidence pertaining to outcome measurement and identify implementation considerations for use of outcome measures among adults and children living with Long COVID and their caregivers.

We will conduct a scoping study involving: (1) an evidence review and (2) a two-phased consultation, using methodological steps outlined by the Arksey and O’Malley Framework and Joanna Briggs Institute. We will answer the following question: What is known about outcome measures used to describe, evaluate or predict health outcomes among adults and children living with Long COVID and their caregivers? Evidence review: we will review peer review published and grey literature to identify existing outcome measures and their reported measurement properties with people living with Long COVID and their caregivers. We will search databases including MEDLINE, Embase, CINAHL, PsycINFO and Scopus for articles published since 2020. Two authors will independently review titles and abstracts, followed by full text to select articles that discuss or use outcome measures for Long COVID health outcomes, pertain to adults or children living with Long COVID and/or their caregivers and are based in research or clinical settings. We will extract data including article characteristics, terminology and definition of Long COVID, health outcomes assessed, characteristics of outcome measures, measurement properties and implementation considerations. We will collate and summarise data to establish a preliminary Framework of Measurement. Consultation phase 1: we will conduct an environmental scan involving a cross-sectional web-based questionnaire among individuals with experience using or completing outcome measures for Long COVID, to identify outcome measures not found in the evidence review and explore implementation considerations for outcome measurement in the context of Long COVID. Consultation phase 2: we will conduct focus groups to review the preliminary Framework of Measurement and to highlight implementation considerations for outcome measurement in Long COVID. We will analyse questionnaire and focus group data using descriptive and content analytical approaches. We will refine the Framework of Measurement based on the focus group consultation using community-engaged approaches with the research team.

Protocol approved by the University of Toronto Health Sciences Research Ethics Board (protocol #46503) for the consultation phases of the study. Outcomes will include a Framework of Measurement, to enhance measurement of health outcomes in Long COVID research and clinical practice. Knowledge translation will also occur in the form of publications and presentations.

Secondary and tertiary renal hyperparathyroidism (RHPT) are common sequelae of chronic kidney disease and are associated with worse patient mortality and quality of life. Clinical guidelines remain lacking with regard to recommendations for using intraoperative parathyroid hormone (IOPTH) during surgery for RHPT. A prospective randomised study will help evaluate the role of IOPTH in guiding surgery for secondary and tertiary RHPT.

Intraoperative parathyroid hormone monitoring to guide surgery in renal hyperparathyroidism is a pragmatic, multicentre, five-arm, parallel-group, patient-blinded and outcome assessor-blinded prospective pilot trial used to evaluate the feasibility of performing a definitive trial. Eligible participants include adult patients diagnosed with secondary or tertiary hyperparathyroidism who are candidates for subtotal or total parathyroidectomy. Consenting patients will be randomly assigned, through central allocation, in a 1:1:1:1:1 fashion to undergo surgery with IOPTH monitoring (four experimental arms: postexcision IOPTH samples taken at 10, 15, 20 or 25 min) or to undergo surgery without IOPTH monitoring (control arm). The primary feasibility objective is to estimate the percentage of eligible patients that are randomised: ≥70% proceed; 50–69% modify protocol before proceeding;

Ethics approval was obtained from the Hamilton Integrated Research Ethics Board. Pilot trial results will be shared widely through local, national and international academic and clinical networks and will be disseminated through conference presentations and publication in peer-reviewed journals.

NCT06542315, registered on 6 August 2024.

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).

The increasing prevalence of chronic conditions and multimorbidity places a significant burden on patients and leads to increasing challenges for healthcare systems, especially in primary care. Recognising the multifaceted nature of chronic conditions, the Assessment of Burden of Chronic Conditions (ABCC) tool was developed to support person-centred care, by facilitating shared decision-making and self-management. This study aims to evaluate the cost-effectiveness of the ABCC tool in primary care.

This cost-effectiveness analysis was conducted over 18 months alongside a clustered, two-arm quasi-experimental study in primary care in the Netherlands.

The study included 231 participants diagnosed with chronic obstructive pulmonary disease (COPD), asthma, type 2 diabetes mellitus (T2DM) and/or chronic heart failure (CHF). Of these, 173 were assigned to the intervention group and 58 to the control group.

The intervention group was intended to incorporate the ABCC tool into routine consultations, while the control group had to continue care as usual.

Outcomes were assessed from a societal perspective, including quality-adjusted life years (QALYs) derived via the EuroQol-5D-5L (EQ-5D-5L) questionnaire. Costs were measured using adapted versions of the Productivity Costs Questionnaire (PCQ) and Medical Consumption Questionnaire (MCQ). Sensitivity analyses (SAs) included a healthcare perspective, per-protocol analysis (to account for disruptions caused by COVID-19) and exclusion of home care costs (to address extreme outliers). Moreover, all analyses were performed for well-being-adjusted life years (WALYs), derived from the ICEpop CAPability measure for Adults (ICECAP-A) questionnaire.

The ABCC tool was more expensive and effective than usual care, with an incremental cost-effectiveness ratio (ICER) of 64 525 per QALY and a 29% probability of cost-effectiveness. With the exception of the healthcare perspective, the SAs yielded more favourable outcomes in terms of cost-effectiveness, with ICERs (probability of cost-effectiveness) of 41 484 (31%), 8683 (58%) and 23 905 (48%) for a healthcare perspective, per-protocol analysis and exclusion of home care costs, respectively. Outcomes for QALY and WALY were comparable.

While the primary analysis suggested a relatively low probability of cost-effectiveness, the SAs showed higher probabilities. The per-protocol analysis suggested that the ABCC tool can be cost-effective when actually used.

NCT04127383.

Earthen floors are often damp or dusty and difficult to clean, providing an ideal environment for faecal pathogens and parasites. Observational studies have revealed associations between household flooring and health outcomes, but robust experimental evidence is scant. This study will evaluate the impact of an improved household flooring intervention on enteric infections, soil-transmitted helminth (STH) infections and tungiasis through implementation of a cluster-randomised trial in two rural settings in Kwale and Bungoma Counties, Kenya.

440 clusters (households) across both sites are allocated to control or intervention group, in which a low-cost, sealed, washable, cement-based floor is installed in eligible buildings of the dwelling, alongside a floor-care guide provided during an induction meeting. Following baseline assessments in both groups, all individuals over 1 year receive albendazole and those infected with tungiasis receive benzyl benzoate. Primary outcomes are as follows: prevalence of enteric infections in children under 5 years assessed via stool surveys and PCR; prevalence of tungiasis infection in children 1–14 years based on clinical exam; and prevalence of STH infection in all household members over 1 year assessed via Kato-Katz. Secondary outcomes include the following: intensity of STH and tungiasis infections; prevalence of caregiver-reported gastrointestinal illness in children under 5; quality of life and well-being measures; and environmental contamination. A process evaluation investigates intervention acceptability, durability, practicality and cost.

The protocol has been approved by ethics committees of The Kenya Medical Research Institute, The Kenya National Commission for Science Technology and Innovation, and The London School of Hygiene & Tropical Medicine. Following the 12-month implementation period and final assessments, control households are offered improved floors. Results will be disseminated within Kenya, to the Ministries of Health and of Lands, Public Works, Housing and Urban Development, and to subnational leadership and communities. Dissemination will also occur through publications and conference presentations.

NCT05914363.

Anaemia during pregnancy is a widespread health burden globally, especially in low- and middle-income countries, posing a serious risk to both maternal and neonatal health. The primary challenge is that anaemia is frequently undetected or is detected too late, worsening pregnancy complications. The gold standard for diagnosing anaemia is a clinical laboratory blood haemoglobin (Hgb) or haematocrit (Hct) test involving a venous blood draw. However, this approach presents several challenges in resource-limited settings regarding accessibility and feasibility. Although non-invasive blood Hgb testing technologies are gaining attention, they remain limited in availability, affordability and practicality. This study aims to develop and validate a mobile health (mHealth) machine learning model to reliably predict blood Hgb and Hct levels in Black African pregnant women using smartphone photos of the conjunctiva.

This is a single-centre, cross-sectional and observational study, leveraging existing antenatal care services for pregnant women aged 15 to 49 years in Kenya. The study involves collecting smartphone photos of the conjunctiva alongside conventional blood Hgb tests. Relevant clinical data related to each participant’s anaemia status will also be collected. The photo acquisition protocol will incorporate diverse scenarios to reflect real-world variability. A clinical training dataset will be used to refine a machine learning model designed to predict blood Hgb and Hct levels from smartphone images of the conjunctiva. Using a separate testing dataset, comprehensive analyses will assess its performance by comparing predicted blood Hgb and Hct levels with clinical laboratory and/or finger-prick readings.

This study is approved by the Moi University Institutional Research and Ethics Committee (Reference: IREC/585/2023 and Approval Number: 004514), Kenya’s National Commission for Science, Technology, and Innovation (NACOSTI Reference: 491921) and Purdue University’s Institutional Review Board (Protocol Number: IRB-2023-1235). Participants will include emancipated or mature minors. In Kenya, pregnant women aged 15 to 18 years are recognised as emancipated or mature minors, allowing them to provide informed consent independently. The study poses minimal risk to participants. Findings and results will be disseminated through submissions to peer-reviewed journals and presentations at the participating institutions, including Moi Teaching and Referral Hospital and Kenya’s Ministry of Health. On completion of data collection and modelling, this study will demonstrate how machine learning-driven mHealth technologies can reduce reliance on clinical laboratories and complex equipment, offering accessible and scalable solutions for resource-limited and at-home settings.

The aetiology of sudden sensorineural hearing loss (SSNHL) is not certain in a significant number of cases. In 8%–31% of posterior fossa infarctions, acute hearing or vestibular loss precedes neurological symptoms. Also, several retrospective cohort analyses have indicated a higher chance of experiencing a stroke after SSNHL compared with the general population. This higher incidence of stroke suggests vascular involvement in the pathophysiology of SSNHL. The aim of this study is to evaluate the association of cardiovascular disease and idiopathic SSNHL (iSSNHL) by investigating the presence of cardiovascular risk factors and cerebral small vessel disease (CSVD), in patients with iSSNHL and compare this to controls.

In this multicentre cross-sectional study, the ROSALIE study, 205 patients aged 50 years or higher diagnosed with iSSNHL, and 205 controls who are either suspected of trigeminus neuralgia, hemifacial spasm, vestibular paroxysmia or have a cerebellopontine angle neoplasm will be included. The primary outcome is the difference in CSVD, measured by the degree of white matter hyperintensities according to the Fazekas scale and the presence of brain infarctions on MRI, between patients with iSSNHL and controls. The secondary outcome is the difference in prevalence of the cardiovascular risk factors: hypertension, hypercholesterolaemia, smoking status, body mass index and cardiovascular comorbidities; diabetes, stroke and myocardial infarction, between both cohorts.

Ethics approval has been obtained by the institutional review boards of all participating hospitals. The Medical Research Involving Human Subjects Act does not apply to this study, as has been declared by the regional review board at Leiden University Hospital, registration number 22-3060.

Patients will receive the standard diagnostic protocol for iSSNHL in the Netherlands, which consists of pure tone audiometric assessment before and after treatment with corticosteroids and an MRI of the cerebellopontine angle displaying the entire cerebrum. The data will not be available publicly but might be shared on a reasonable request.

Individuals with stroke or spinal cord injury (SCI) often have poor balance control, leading to falls and activity limitations. One intervention that targets balance control—functional electrical stimulation with visual feedback balance training (FES+VFBT)—may improve balance control but needs modifications for clinical use.

To use a participatory design approach to identify potential challenges and solutions for the clinical implementation of FES+VFBT as a balance intervention.

A descriptive qualitative study involving four semi-structured focus group meetings was conducted to explore the perspectives of individuals with stroke and SCI, physical therapists and a hospital administrator on the feasibility and challenges of implementing FES+VFBT into clinical settings. The interviews were transcribed and analysed using deductive and inductive content analyses. The deductive analysis was based on the social ecological model (SEM) levels, while the inductive approach was used to identify categories and codes.

Virtual.

Two individuals with chronic SCI and one individual with chronic stroke who were able to stand but reported deficits in their balance control. Two physical therapists who had experience with FES and the rehabilitation of individuals with SCI or stroke. One hospital administrator who worked within a neurological rehabilitation setting.

Themes were organised according to the SEM’s four levels: intrapersonal, interpersonal, organisational/training environment and society/policy. Identified categories included potential challenges at the intrapersonal level (ie, lack of knowledge, safety and tolerance of user) and organisational/training environment level (ie, technical challenges, cost, physical space and time). The categories also included possible solutions at all SEM levels, such as intrapersonal (ie, reading and education), interpersonal (ie, practising together), organisational/training environment (ie, technology characteristics and creating resources) and society/policy (ie, purchasing options, guidelines and foundation grants).

End-users identified anticipated challenges and solutions to using the FES+VFBT system clinically. The results will inform the design and clinical implementation of a revised version of the system and other FES devices.