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

Living with epilepsy, especially drug-resistant epilepsy (DRE), imposes several challenges for people diagnosed with the condition. These challenges include the physical and mental implications of epilepsy on both caregivers and patients with epilepsy. For the more than 120 000 individuals living with this neurological disorder in the Netherlands, along with their families, daily activities become hazardous, limited and costly, significantly affecting their health-related quality of life (HRQoL). As data on the burden of epilepsy in the Netherlands are lacking, studies attempting to capture the impact of epilepsy on individuals, caregivers and society are needed to enhance understanding and help address the burden of epileptic seizures.

The study is part of the AIM@EPILEPSY project. The project aims to develop a planning suite enabling cost-saving, minimally invasive treatment for epilepsy. By surveying 330 people with epilepsy and an anticipated sample of 150–200 informal caregivers across the Netherlands, using standardised questionnaires focusing on associated societal costs and the impact on HRQoL, this bottom-up, prevalence-based prospective study aims to understand the societal burden of DRE in the Netherlands. The data will be collected at 0, 3, 6 and 12 months of follow-up. The study results will describe the economic impact of epilepsy, focusing on cost-of-illness () and HRQoL (utilities) in the Netherlands.

The proposed study was approved by the Maastricht University Medical Ethics Review Committee (Approval reference: FHML-REC/2024/067/Amendment/2024_16). The result of the study is planned to be published in a peer-reviewed journal and presented at international and local scientific conferences.

Patients with stage III non-small cell lung cancer (NSCLC) are at high risk of developing post-treatment recurrences (50–78%) during follow-up. As more effective treatments are now available, especially for patients with oligometastatic disease, earlier detection of recurrences may prolong survival and health-related quality of life (HRQOL). With the use of 2'-deoxy-2'-[¹⁸F]fluoroglucose positron emission tomography/CT ([¹⁸F]FDG PET/CT) during follow-up, recurrences may be detected earlier. Therefore, the primary objective of this study is to compare the 3-year overall survival of patients with stage III NSCLC during follow-up surveillance with [¹⁸F]FDG PET/CT versus follow-up with conventional CT (usual care). Secondary objectives address the number, location and timing of recurrences, as well as HRQOL, cost-effectiveness and patient experiences of PET/CT scans.

In this multicentre randomised controlled clinical trial, 690 patients with stage III NSCLC (8th edition International Association for the Study of Lung Cancer (IASLC) Tumor, Nodes, Metastasis (TNM) classification) who completed curative intended treatment and started follow-up care (which may include adjuvant therapy) will be randomised 1:1 to either the intervention ([¹⁸F]FDG PET/CT) or the control group (CT). Patients will undergo follow-up scans during visits at 6, 12, 18, 24 and 36 months. Data will be collected using validated questionnaires, electronic case report forms and data extractions from the electronic health records. Additionally, blood samples will be collected, and interviews will be conducted.

The study protocol has been approved by the Medical Ethical Committee of the Radboudumc and review boards of all participating centres. Written informed consent will be obtained from all participants. Study results will be published in international peer-reviewed scientific journals and presented at relevant scientific conferences. Data will be published in a data repository or other online data archive.

NCT06082492.

Conventional cardiotocography (CTG) has been used extensively to monitor the fetal condition during labour. However, conventional non-invasive monitoring is limited by the difficulty of obtaining an adequate signal quality, particularly in the case of obese parturients. Furthermore, the rate of operative deliveries keeps rising despite the ability for conventional intrapartum monitoring. Electrophysiological monitoring is an alternative technique that has been developed over the past decades to improve signal quality. This non-invasive, transabdominal and wireless alternative measures fetal heart rate by fetal electrocardiography (NI-fECG), and uterine activity by electrohysterography (EHG). Both NI-fECG and EHG have been proven to be more accurate and reliable than conventional non-invasive methods and are less affected by maternal Body Mass Index. Nevertheless, it is still unknown whether electrophysiological intrapartum monitoring leads to better obstetric and neonatal outcomes. This study aims to investigate whether electrophysiological monitoring during labour affects the number of operative interventions compared with conventional monitoring during labour.

This is a single-centre cohort intervention random sampling study which will be performed in a tertiary obstetric care centre. In total, 3471 term pregnant women with a singleton fetus in cephalic position and indication for continuous fetal monitoring during labour will be included. Eligible women will be prospectively included in the cohort for conventional monitoring. From these women, 90.9% of women will be randomly sampled and will be offered electrophysiological monitoring. A historical cohort of an additional 2100 women who received conventional monitoring will be added to the conventional group. This historical cohort was collected between April 2019 and February 2023. The primary outcome will be the number of operative interventions during labour. Secondary outcome measures include maternal and neonatal outcomes, patient and healthcare professional perspectives and costs.

This study received approval from the Medical Ethics Committee of Máxima Medical Centre (W22.071) on 1 November 2023. All participants will provide informed consent prior to data collection. Results of the study will be disseminated in peer-reviewed scientific journals and conference presentations.

NCT06135961.

This study aimed to evaluate the utility of optical sensor-based technology in mitigating the frequency and severity of peripheral intravenous infiltration and/or extravasation (PIVIE) in neonates.

Single-centre, retrospective, observational cohort study.

Tertiary-level neonatal intensive care unit (NICU) (112 cots) at the Women’s Wellness and Research Centre (WWRC), Hamad Medical Corporation (HMC), Doha, Qatar, January 2019–December 2022.

All neonates admitted to the NICU requiring intravenous therapy via a neonatal short peripheral intravenous catheter (n-SPC) were included. Participants were excluded if the insertion was unsuccessful, if they had incomplete data, or if they received intravenous therapy exclusively through alternative vascular access devices.

The study analysed two cohorts representing different clinical practices over two distinct periods. In the conventional cohort (Phase 1, 2019–2020), PIVIE detection relied solely on periodic ‘Touch Look Compare (TLC)’ assessments. In the ivWatch cohort (Phase 2, 2021–2022), continuous optical sensor-based monitoring using the ivWatch system was implemented alongside TLC assessments. This sequential design allowed for a comparison of outcomes between the two phases.

The primary outcomes were the occurrence and severity of PIVIE. Secondary outcomes included the influence of patient demographics, vascular access characteristics, and management details on PIVIE incidence and severity.

Over the 4-year data collection period, 32 713 peripheral intravenous catheters were analysed across two cohorts. PIVIE was the most common reason for unplanned device removal. In the conventional cohort (Phase 1, 2019–2020), 4941 infiltration events were reported (29.9%), compared with 4872 events (30.1%) in the ivWatch cohort (Phase 2, 2021–2022). However, severity measures using the Intravenous Extravasation Grading Scale (IEGS) revealed a marked reduction in severe PIVIE cases, with severe events decreasing from 243 (4.9%) in the conventional cohort to 54 (1.1%) in the ivWatch cohort (p

PIVIE remains a frequent complication in neonatal vascular access. Continuous site monitoring with optical sensor technology was associated with earlier detection of PIVIE events and reduced IEGS severity scores. These findings highlight the potential of integrating sensor-based monitoring with traditional observational methods to improve patient outcomes in neonatal care.

Due to nursing shortages, an ageing population and increasing care demand, there is a growing interest in parenteral medication administration at home (PMAaH), comprising the administration of parenteral medication in the home situation of patients. The operational design of such PMAaH care pathways is complex, resulting in many variations of adoptions, showing a need for a quality framework. Although quality indicators (QIs) have been proposed to monitor the quality of specific care pathways, a generic quality framework for all types of PMAaH is lacking. Therefore, this study proposes a generic quality set for PMAaH, which includes structure and process QIs, to benchmark and redesign PMAaH care pathways to ensure high quality.

A generic QI set was developed for PMAaH using a systematic RAND appropriateness method adapted at the third phase. This method consisted of a scoping review to identify indicators, an expert panel rating phase including an online questionnaire and subsequent panel meeting to assess the appropriateness of the indicators and a retrospective practice testing to evaluate the feasibility, clarity and measurability of the indicators. After the practice testing, which consisted of an online questionnaire where experts could indicate the implementation state of all indicators in their hospital, a third expert panel adjusted the set to increase the likelihood of implementation in practice.

The experts, all healthcare professionals involved in PMAaH processes, were recruited using the snowball sampling technique from three large Dutch, teaching hospitals. Subsequently, a practice testing by self-assessment was conducted in seven large Dutch teaching hospitals.

17 and seven healthcare professionals with diverse backgrounds participated in the online questionnaire and panel meeting, respectively.

The scoping review resulted in 36 QIs for PMAaH. After two expert panel rating rounds (online questionnaire and panel meeting), two indicators were removed: a QI related to travel distance policy since it was irrelevant and redundant, and a QI stating that a clinician should take the lead in a PMAaH-team, which was deemed too restrictive. After the practice testing, two QIs were removed: a QI related to clinical response documentation, which was unclear for the practice testing respondents and already covered by other QIs, and a QI related to survival documentation, which was deemed infeasible and undesirable to measure this differently than other patients by the third expert panel.

The final set consists of 32 indicators (of which 15 were structure indicators and 17 were process indicators). The final set predominately includes QIs that are aimed at patient safety but also QIs focusing on the working conditions of the healthcare workers. 17.6% of the QIs are currently fully implemented in general in all seven hospitals. The practice testing revealed that operational QIs are more frequently implemented in practice than systemic QIs and that a structured quality assurance programme is needed in the hospitals.

This study proposes a generic quality set for PMAaH that hospitals can use to redesign and benchmark PMAaH care pathways to assure high quality. The practice testing confirmed that there is a need for this structured quality set.

To explore facilitators and barriers in the financial model of hospitals when a change in a care pathway is implemented.

A qualitative research reported according to the Consolidated Criteria for Reporting Qualitative Research.

Five hospitals in the Netherlands, between February and September 2023.

28 interviewees with 7 different stakeholders: (director of) healthcare procurement, contracting manager, financial, business or project manager, physical therapist, board of Medical Consultant Group and surgeon.

The absence of permanent funding in the hospital reimbursement model and the allocation of available resources in the internal hospital distribution model are the two most important barriers when implementing prehabilitation for patients with colorectal cancer. The main facilitator was found to be the internal provision of spare budget. Lump sum agreements are the preferred contract type because they may facilitate internal substitution of budgets according to need. Bundling primary and hospital care funding is recommended to overcome barriers in the financial model. Activity-based budgeting is the preferred budgeting method because budgets can be adjusted over time according to costs. Cost reduction can only be achieved when prehabilitation is offered to more patients. In addition to an appropriate financial model, preconditions like the involvement of a medical specialist and sense of urgency in the organisation should also be arranged.

The financial model of hospitals may affect the implementation of changes in care pathways. Despite barriers in both the reimbursement and the distribution model, it is possible to facilitate this transformation.

To determine the golf-related characteristics of spinal injuries among professional golfers in South Korea.

Cross-sectional survey study.

Online survey in South Korea.

A total of 439 professional active golfers (226 males and 213 females) in South Korea completed our survey.

Data collected included experiences of cervical (C)-spine and thoracic and lumbar (T/L)-spine injuries, demographics and golf-related characteristics among Korean professional golfers. Logistic regression analysis was used to explore any potential factors of golf-related spinal injuries.

A total of 33.7% (148 of 439) experienced total spine injury in professional active golfers, presenting 15.5% of C-spine injuries and 21.9% of T/L-spine injuries. Multivariate logistic regression analysis showed that left-handed (OR, 2.79; 95% CI, 1.20 to 6.47 compared with right-handed) and fingertips

Nearly 33.7% of Korean professional active golfers have experienced golf-related spinal injuries. These injuries appear to make left-handed golfers more vulnerable; however, adequate flexibility may offer protection against such injuries, suggesting the need for tailored preventative strategies based on individual biomechanical profiles.

Prediction models for post-stroke mortality can support medical decision-making. Although numerous models have been developed, external validation studies determining the models’ transportability beyond the original settings are lacking. We aimed to assess the performance of two prediction models for post-stroke mortality in Berlin, Germany.

We used data from the Berlin-SPecific Acute Treatment in Ischaemic or hAemorrhagic stroke with Long-term follow-up (B-SPATIAL) registry.

Multicentre stroke registry in Berlin, Germany.

Adult patients admitted within 6 hours after symptom onset and with a 10th revision of the International Classification of Diseases discharge diagnosis of ischaemic stroke, haemorrhagic stroke or transient ischaemic attack at one of 15 hospitals with stroke units between 1 January 2016 and 31 January 2021.

We evaluated calibration (calibration-in-the-large, intercept, slope and plot) and discrimination performance (c-statistic) of Bray et al’s 30-day mortality and Smith et al’s in-hospital mortality prediction models. Information on mortality was supplemented by Berlin city registration office records.

For the validation of Bray et al’s model, we included 7879 patients (mean age 75; 55.0% men). We observed 763 (9.7%) deaths within 30 days of stroke compared with 680 (8.6%) predicted. The model’s c-statistic was 0.865 (95% CI: 0.851 to 0.879). For Smith et al’s model, we performed the validation among 1931 patients (mean age 75; 56.2% men), observing 105 (5.4%) in-hospital deaths compared with the 92 (4.8%) predicted. The c-statistic was 0.891 (95% CI: 0.864 to 0.918). The calibration plots of both models revealed an underestimation of the mortality risk for high-risk patients.

Among Berlin stroke patients, both models showed good calibration performance for low and medium-risk patients and high discrimination while underestimating risk among high-risk patients. The acceptable performance of Bray et al’s model in Berlin illustrates how a small number of routinely collected variables can be sufficient for valid prediction of post-stroke mortality.

Osteoarthritis (OA) is a multifactorial disease in which low-grade inflammation is considered to play a pivotal role. Although colchicine is a widely used anti-inflammatory drug in the treatment of gout, its effect in OA is still disputed due to inconsistent results of short-term clinical trials. Therefore, we aim to evaluate the effect of long-term colchicine 0.5 mg once daily on the incidence of knee or hip replacements in patients with knee or hip OA.

The ECHO trial is a prospective, multicentre, randomised, double-blind, placebo-controlled, phase III trial in which 1200 participants with knee or hip OA tolerant to colchicine during a 30-day run-in period will be 1:1 randomised to colchicine 0.5 mg once daily or matching placebo using concealed allocation. The primary endpoint is the time from randomisation to the first knee or hip replacement assessed up to 4.5 years. Secondary endpoints include course of pain, physical function, joint space narrowing, low-grade inflammation, quality of life, clinical or radiological onset of OA in a new joint group other than present at baseline, number of participants using pain medication during the study, onset of new cardiovascular events (ie, myocardial infarction, ischaemia-driven coronary revascularisation, ischaemic stroke, peripheral artery disease or cardiovascular death) and direct and indirect costs related to treatment and disease burden due to OA. Harm-related endpoints include the number of (serious) adverse events, the number of withdrawals due to (serious) adverse events and changes in laboratory data (ie, serum creatinine, estimated glomerular filtration rate and alanine transferase) throughout the study. The primary analysis will be performed according to the intention-to-treat principle.

This trial has been approved by the Medical Ethics Review Committee East-Netherlands. Findings will be presented at scientific meetings and published in a peer-reviewed scientific journal.

NCT06578182.