Publications by authors named "Ouwens M"

In schema therapy early adaptive schemas (EASs) and early maladaptive schemas (EMSs) have been found to be independent but related constructs. The Young Positive Schema Questionnaire (YPSQ) was developed and validated in English to measure EASs. The present study investigated psychometric properties of the Dutch translation in a representative sample of 650 non-clinical Dutch individuals.

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Marketing authorization holders of vaccines typically need to report brand-specific vaccine effectiveness (VE) to the regulatory authorities as part of their regulatory obligations. COVIDRIVE (now id. DRIVE) is a European public-private partnership for respiratory pathogen surveillance and studies of brand-specific VE with long-term follow-up.

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  • Mineralocorticoid receptor antagonists (MRA) like spironolactone are effective for heart failure with reduced ejection fraction but are often underused due to hyperkalemia concerns.
  • The REALIZE-K trial tested the effects of sodium zirconium cyclosilicate (SZC) in helping patients with heart failure and hyperkalemia effectively use spironolactone.
  • Results showed that participants who received SZC had significantly better outcomes in terms of maintaining normal potassium levels and continuing on spironolactone compared to those on a placebo.
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  • Randomised controlled trials often use surrogate endpoints instead of direct outcomes to enhance efficiency and reduce costs, but this can lead to increased uncertainty regarding treatment effects and intervention harms.
  • A new guideline, known as CONSORT-Surrogate, provides a checklist for reporting trials that utilize surrogate endpoints, ensuring better clarity and transparency in the results.
  • The recommended checklist, tailored for all stakeholders involved in clinical trials, aims to improve the reporting quality of these studies and ultimately reduce wasted research efforts.
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  • Randomised controlled trials often use surrogate endpoints instead of direct outcomes to save time, cost, and ethical concerns, but this can create uncertainty about the actual treatment effects and potential harms.
  • The SPIRIT-Surrogate is a new guideline to enhance the reporting standards for trial protocols that use surrogate endpoints, building on the existing SPIRIT checklist.
  • This guideline includes nine modified items, encouraging all stakeholders to adopt it, which aims to improve trial design, transparency, and ultimately reduce wasted research efforts.
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Background: There is a lack of evidence regarding the relationship between family involvement and outcomes in gastrointestinal oncology patients after surgery. To evaluate the effect of a family involvement program for patients undergoing oncologic gastrointestinal surgery on unplanned readmissions within 30 days after surgery.

Methods: A multicenter patient-preference cohort study compared 2 groups: patients who participated in the family involvement program versus usual care.

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Whether 30-day modified Rankin Scale (mRS) scores can predict 90-day scores is unclear. This study derived and validated a model to predict ordinal 90-day mRS score in an intracerebral hemorrhage (ICH) population using 30-day mRS values and routinely available baseline variables. Adults enrolled in the Antihypertensive Treatment of Acute Cerebral Hemorrhage-2 (ATACH-2) trial between May 2011 and September 2015 with acute ICH, who were alive at 30 days and had mRS scores reported at both 30 and 90 days were included in this post-hoc analysis.

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Background: Chronic kidney disease (CKD) presents a significant clinical and economic burden to healthcare systems worldwide, which increases considerably with progression towards kidney failure. The Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) trial demonstrated that patients with or without type 2 diabetes who were treated with dapagliflozin experienced slower progression of CKD versus those receiving placebo. Understanding the effect of long-term treatment with dapagliflozin on the timing of kidney failure beyond trial follow-up can assist informed decision-making by healthcare providers and patients.

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Objectives: Despite being prioritized during initial COVID-19 vaccine rollout, vulnerable individuals at high risk of severe COVID-19 (hospitalization, intensive care unit admission, or death) remain underrepresented in vaccine effectiveness (VE) studies. The RAVEN cohort study (NCT05047822) assessed AZD1222 (ChAdOx1 nCov-19) two-dose primary series VE in vulnerable populations.

Methods: Using the Oxford-Royal College of General Practitioners Clinical Informatics Digital Hub, linked to secondary care, death registration, and COVID-19 datasets in England, COVID-19 outcomes in 2021 were compared in vaccinated and unvaccinated individuals matched on age, sex, region, and multimorbidity.

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Objective: This study aimed to describe longitudinal trajectories of Total Weight Loss (%TWL), and mental and physical health related quality of life (HRQOL), as well as to identify preoperative psychological predictors of these trajectories.

Methods: A prospective observational study including Dutch patients treated with metabolic and bariatric surgery (n = 420, age 44.8 ± 10.

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Purpose: Exacerbations of chronic obstructive pulmonary disease (COPD) are associated with deteriorating health and health-related quality of life (HRQoL) among people with COPD during and after events. HRQoL data are key to evaluating treatment cost-effectiveness and informing reimbursement decisions in COPD. EuroQoL 5-dimension 5-level (EQ-5D-5L) utility scores, based on various HRQoL measures, are used in economic evaluations of pharmacotherapy.

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After receiving an autism diagnosis, psychoeducation (i.e. information regarding autism) is a first intervention.

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National Institute for Health and Care Excellence guidance (Technical Support Document 19) highlights a key challenge of state transition models (STMs) being their difficulty in achieving a satisfactory fit to the observed within-trial endpoints. Fitting poorly to data over the trial period can then have implications for long-term extrapolations. A novel estimation approach is defined in which the predicted overall survival (OS) and progression-free survival (PFS) extrapolations from an STM are optimized to provide closer estimates of the within-trial endpoints.

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Article Synopsis
  • The paper discusses the increasing use of surrogate endpoints in interventional trials and introduces a framework for better defining and reporting them.
  • A series of studies, including reviews and surveys involving various stakeholders, revealed inconsistencies in how surrogate endpoints are currently defined and understood.
  • It was found that while traditional surrogate endpoints focus on biomarkers, broader interpretations including intermediate outcomes like function or symptoms also require clearer consensus among stakeholders, particularly between patients and health technology experts.
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Background: Although COVID-19 booster vaccination is widely recommended, there is limited long-term, population-level, real-world evidence on the magnitude of improved protection against severe COVID-19 conferred by boosting with monovalent COVID-19 vaccines developed against ancestral SARS-CoV-2, especially in low- or middle-income countries. We present interim results from the first large-scale assessment of the relative vaccine effectiveness (rVE) of first and second booster doses against severe COVID-19 in a low-/middle-income country.

Methods: REFORCO-Brazil is an ongoing, test-negative case-control study (NCT05697705) utilizing Brazil national severe acute respiratory syndrome (SARS) surveillance and vaccination data.

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Objective: The aim of this study was to explore the effectiveness of schema therapy (ST) in older adults with borderline personality disorder (BPD).

Methods: Multiple baseline case series design with five BPD patients, with a mean age of 66. After a baseline phase with random length, patients received weekly ST sessions for a year, followed by follow-up sessions during 6 months.

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Objective: THALES demonstrated that ticagrelor plus aspirin reduced the risk of stroke or death but increased bleeding versus aspirin during the 30 days following a mild-to-moderate acute non-cardioembolic ischaemic stroke (AIS) or high-risk transient ischaemic attack (TIA). There are no cost-effectiveness analyses supporting this combination in Europe. To address this, a cost-effectiveness analysis was performed.

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Objective: Chronic obstructive pulmonary disease (COPD) is a leading cause of death worldwide. While two approved fixed-dose inhaled corticosteroid/long-acting muscarinic antagonist (LAMA)/long-acting β-agonist (LABA) triple therapies reduce all-cause mortality (ACM) versus dual LAMA/LABA therapy in patients with COPD, head-to-head studies have not compared the effects of these therapies on ACM. We compared ACM in adults with moderate-to-very severe COPD receiving budesonide/glycopyrrolate/formoterol fumarate (BGF) in ETHOS versus fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) in IMPACT using a matching-adjusted indirect comparison (MAIC).

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Background: Vaccine effectiveness (VE) studies with long-term follow-up are needed to understand durability of protection against severe COVID-19 outcomes conferred by primary-series vaccination in individuals not receiving boosters. COVIDRIVE is a European public-private partnership evaluating brand-specific vaccine effectiveness (VE). We report a prespecified interim analysis of primary-series AZD1222 (ChAdOx1 nCoV-19) VE.

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Article Synopsis
  • - The objective of this study was to review existing literature on surrogate endpoints in clinical trials, focusing on their definitions, acceptability, limitations, and providing guidance for design and reporting.
  • - A systematic search led to the inclusion of 90 documents, which revealed that the majority addressed definitions (79%), acceptability (77%), and limitations (72%), resulting in 17 identified trial reporting items for better clarity and guidance.
  • - The findings aim to enhance the understanding of surrogate endpoints in research and will contribute to developing standardized reporting recommendations for their use in interventional trials.
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Introduction: In patients with chronic obstructive pulmonary disease (COPD), the risk of certain cardiovascular (CV) events is increased by threefold to fivefold in the year following acute exacerbation of COPD (AECOPD), compared with a non-exacerbation period. While the effect of severe AECOPD is well established, the relationship of moderate exacerbation or prior exacerbation to elevated risk of CV events is less clear. We will conduct cohort studies in multiple countries to further characterise the association between AECOPD and CV events.

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Introduction: Clinical trials often have short follow-ups, and long-term outcomes such as survival must be extrapolated. Current extrapolation methods often produce a wide range of survival values. To minimize uncertainty in projections, we developed a novel method that incorporates formally elicited expert opinion in a Bayesian analysis and used it to extrapolate survival in the placebo arm of DAPA-CKD, a phase 3 trial of dapagliflozin in patients with chronic kidney disease (NCT03036150).

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Effect modification (EM) may cause bias in network meta-analysis (NMA). Existing population adjustment NMA methods use individual patient data to adjust for EM but disregard available subgroup information from aggregated data in the evidence network. Additionally, these methods often rely on the shared effect modification (SEM) assumption.

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Background: Systems Training for Emotional Predictability and Problem Solving (STEPPS) is a cognitive behavioural therapy-based group treatment programme for patients with borderline personality disorder (BPD). STEPPS has demonstrated its effectiveness for (younger) adults. However, there are no studies into the effects of STEPPS for older adults.

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