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View article: Establishing normative data for EpiTrack Junior in Danish pediatric population – an international comparison
Establishing normative data for EpiTrack Junior in Danish pediatric population – an international comparison Open
The Danish norm sample showed significantly lower test scores compared to the German control group, suggesting that a norm dataset is required to adapt the EpiTrack Junior test to different populations.
View article: “Complex models, marginal benefits--a multi-centre development and validation study of early warning scores across 2·16 million patient admissions addressing intercurrent medical interventions”
“Complex models, marginal benefits--a multi-centre development and validation study of early warning scores across 2·16 million patient admissions addressing intercurrent medical interventions” Open
Summary Background The National Early Warning Score (NEWS) is a nationally recommended, clinically implemented system, used to prevent patient deterioration. While numerous studies have compared predictive models for clinical deterioration…
View article: Designing and Evaluating Bayesian Advanced Adaptive Randomised Clinical Trials: A Practical Guide
Designing and Evaluating Bayesian Advanced Adaptive Randomised Clinical Trials: A Practical Guide Open
Advanced adaptive randomised clinical trials are increasingly used. Compared to their conventional counterparts, their flexibility may make them more efficient, increase the probability of obtaining conclusive results without larger sample…
View article: Beta-Blockers after Myocardial Infarction in Patients without Heart Failure
Beta-Blockers after Myocardial Infarction in Patients without Heart Failure Open
Among patients with a myocardial infarction and a left ventricular ejection fraction of at least 40%, beta-blocker therapy led to a lower risk of death or major adverse cardiovascular events than no beta-blocker therapy. (Funded by the Hea…
View article: Digital implementation strategy to increase SGLT2 inhibitor uptake in heart failure: Study design of EMAIL‐HF
Digital implementation strategy to increase SGLT2 inhibitor uptake in heart failure: Study design of EMAIL‐HF Open
Aims The EMAIL‐HF trial aims to evaluate whether a digital guideline implementation strategy can increase and accelerate initiation of sodium‐glucose co‐transporter 2 (SGLT2) inhibitors in patients with heart failure (HF). Methods and resu…
View article: Impact of reducing childhood poverty on social vulnerability in young adulthood: a simulation study based on nationwide life-course data
Impact of reducing childhood poverty on social vulnerability in young adulthood: a simulation study based on nationwide life-course data Open
Background UN Sustainable Development Goal 1.2 targets a 50% reduction in childhood poverty by 2030. This study explores the potential impact of such a reduction in Denmark on (1) the distribution of individuals over trajectories of childh…
View article: Interrater reliability of the DSM-5 and ICD-11 Criterion A for PTSD and complex PTSD in parents of children with autism using the Life Events Checklist – ERRATUM
Interrater reliability of the DSM-5 and ICD-11 Criterion A for PTSD and complex PTSD in parents of children with autism using the Life Events Checklist – ERRATUM Open
View article: Impact of age on cardiac troponin concentration among healthy individuals
Impact of age on cardiac troponin concentration among healthy individuals Open
gov; Unique identifier: NCT05336435.
View article: A genome-wide cross-trait analysis characterizes the shared genetic architecture between lung and gastrointestinal diseases
A genome-wide cross-trait analysis characterizes the shared genetic architecture between lung and gastrointestinal diseases Open
Lung and gastrointestinal diseases often occur together, leading to more adverse health outcomes than when a disease of one of these systems occurs alone. However, the potential genetic mechanisms underlying lung-gastrointestinal comorbidi…
View article: Evaluating the efficacy of Circle of Security-Parenting as an addition to care-as-usual in families affected by maternal postpartum depression and/or infant social withdrawal: A randomized controlled trial
Evaluating the efficacy of Circle of Security-Parenting as an addition to care-as-usual in families affected by maternal postpartum depression and/or infant social withdrawal: A randomized controlled trial Open
The Circle of Security – Parenting (COSP™) is a psychoeducational intervention aiming at fostering secure child-parent attachment relationships. In a randomized controlled trial, we investigate the effect of COSP™ as an adjunct to care-as-…
View article: Cardiac arrhythmia and hypoglycaemia among individuals with and without diabetes receiving haemodialysis (the CADDY study): a Danish multicentre cohort study
Cardiac arrhythmia and hypoglycaemia among individuals with and without diabetes receiving haemodialysis (the CADDY study): a Danish multicentre cohort study Open
View article: Interrater reliability of the DSM-5 and ICD-11 Criterion A for PTSD and complex PTSD in parents of children with autism using the Life Events Checklist
Interrater reliability of the DSM-5 and ICD-11 Criterion A for PTSD and complex PTSD in parents of children with autism using the Life Events Checklist Open
Background Parents of children with autism a demonstrate elevated traumatic stress symptoms, but seldom receive diagnoses of post-traumatic stress disorder (PTSD) or complex PTSD. An accurate assessment of Criterion A is essential for a va…
View article: Designing and evaluating advanced adaptive randomised clinical trials: a practical guide
Designing and evaluating advanced adaptive randomised clinical trials: a practical guide Open
Background: Advanced adaptive randomised clinical trials are increasingly used. Compared to their conventional counterparts, their flexibility may make them more efficient, increase the probability of obtaining conclusive results without l…
View article: Applying the Causal Roadmap to longitudinal national registry data in Denmark: A case study of second-line diabetes medication and dementia
Applying the Causal Roadmap to longitudinal national registry data in Denmark: A case study of second-line diabetes medication and dementia Open
The Causal Roadmap is a formal framework for causal and statistical inference that supports clear specification of the causal question, interpretable and transparent statement of required causal assumptions, robust inference, and optimal p…
View article: Associations between Clinical Phenotypes and Mortality in Individuals with Severe Mental Illnesses (SMIs)
Associations between Clinical Phenotypes and Mortality in Individuals with Severe Mental Illnesses (SMIs) Open
View article: Association between incidence of hypomagnesemia and better prognosis of NSCLC: A case on the immortal time bias
Association between incidence of hypomagnesemia and better prognosis of NSCLC: A case on the immortal time bias Open
Background Previous studies predominantly reported that the occurrence of hypomagnesemia was associated with improved cancer prognoses. However, utilizing publicly available data, we demonstrated the presence of bias in this association, a…
View article: A surrogate endpoint-based provisional approval causal roadmap, illustrated by vaccine development
A surrogate endpoint-based provisional approval causal roadmap, illustrated by vaccine development Open
Summary For many rare diseases with no approved preventive interventions, promising interventions exist. However, it has proven difficult to conduct a pivotal phase 3 trial that could provide direct evidence demonstrating a beneficial effe…
View article: Efficacy and safety of a 72‐h infusion of prostacyclin (1 ng/kg/min) in mechanically ventilated patients with pulmonary infection and endotheliopathy—protocol for the multicenter randomized, placebo‐controlled, blinded, investigator‐initiated <scp>COMBAT</scp>‐<scp>ARF</scp> trial
Efficacy and safety of a 72‐h infusion of prostacyclin (1 ng/kg/min) in mechanically ventilated patients with pulmonary infection and endotheliopathy—protocol for the multicenter randomized, placebo‐controlled, blinded, investigator‐initiated <span>COMBAT</span>‐<span>ARF</span> trial Open
Background Acute respiratory failure (ARF) is common in critically ill patients, and 50% of patients in intensive care units require mechanical ventilation [3, 4]. The COVID‐19 pandemic revealed that COVID‐19 infection induced ARF caused b…
View article: Post-Traumatic Stress Disorder Symptomatology in Parents of Autistic Children: A Systematic Review and Meta-Analysis
Post-Traumatic Stress Disorder Symptomatology in Parents of Autistic Children: A Systematic Review and Meta-Analysis Open
This review examines post-traumatic stress disorder symptoms and associated factors, amongst parents of autistic children. A systematic review of the literature produced seven studies (N=1717) that met the selection criteria. A random-effe…
View article: The “SES NXT” digital intervention for children of relationship dissolution: Study protocol for a randomized controlled trial study
The “SES NXT” digital intervention for children of relationship dissolution: Study protocol for a randomized controlled trial study Open
Parental relationship dissolution is among the most prevalent life crises for youths and is associated with both short- and long-term intra- and interpersonal struggles. Extant support programs tend to be in-person and in a group format. H…
View article: Simplifying Causal Mediation Analysis for Time-to-Event Outcomes using Pseudo-Values
Simplifying Causal Mediation Analysis for Time-to-Event Outcomes using Pseudo-Values Open
Mediation analysis for survival outcomes is challenging. Most existing methods quantify the treatment effect using the hazard ratio (HR) and attempt to decompose the HR into the direct effect of treatment plus an indirect, or mediated, eff…
View article: Carotid plaque thickness predicts cardiovascular events and death in patients with chronic kidney disease
Carotid plaque thickness predicts cardiovascular events and death in patients with chronic kidney disease Open
Background Classical risk scoring systems underestimate the risk of cardiovascular disease in chronic kidney disease (CKD). Coronary artery calcium score (CACS) has improved prediction of cardiovascular events in patients with CKD. The max…
View article: Lower or Higher Oxygenation Targets in Patients With COVID-19 in the ICU
Lower or Higher Oxygenation Targets in Patients With COVID-19 in the ICU Open
gov.
View article: Iloprost and Organ Dysfunction in Adults With Septic Shock and Endotheliopathy
Iloprost and Organ Dysfunction in Adults With Septic Shock and Endotheliopathy Open
Importance Soluble thrombomodulin is a marker of endotheliopathy, and iloprost may improve endothelial function. In patients with septic shock, high plasma levels of soluble thrombomodulin (>10 ng/mL) have been associated with worse…
View article: Long-term mortality and health-related quality of life with lower versus higher oxygenation targets in intensive care unit patients with COVID-19 and severe hypoxaemia
Long-term mortality and health-related quality of life with lower versus higher oxygenation targets in intensive care unit patients with COVID-19 and severe hypoxaemia Open
View article: Associations between enteral nutrition and outcomes in the <scp>SUP</scp>‐<scp>ICU</scp> trial: Results of exploratory post hoc analyses
Associations between enteral nutrition and outcomes in the <span>SUP</span>‐<span>ICU</span> trial: Results of exploratory post hoc analyses Open
Background Enteral nutrition may affect risks of gastrointestinal bleeding, pneumonia and mortality in critically ill patients and may also modify the effects of pharmacological stress ulcer prophylaxis. We undertook post hoc analyses of t…
View article: Empirical meropenem versus piperacillin/tazobactam for adult patients with sepsis (<scp>EMPRESS</scp>) trial: Protocol
Empirical meropenem versus piperacillin/tazobactam for adult patients with sepsis (<span>EMPRESS</span>) trial: Protocol Open
Background Piperacillin/tazobactam may be associated with less favourable outcomes than carbapenems in patients with severe bacterial infections, but the certainty of evidence is low. Methods The Empirical Meropenem versus Piperacillin/Taz…
View article: Potential Mediating Role of Iron Biomarkers in the Association of Sex With Glucose, Insulin, and Type 2 Diabetes
Potential Mediating Role of Iron Biomarkers in the Association of Sex With Glucose, Insulin, and Type 2 Diabetes Open
Context Sex-specific prevalence and incidence of type 2 diabetes (T2D) have been reported, but the underlying mechanisms are uncertain. Objective In this study, we aimed to investigate whether iron biomarkers mediate the association betwee…
View article: DANSPOT: A Multicenter Stepped‐Wedge Cluster‐Randomized Trial of the Reclassification of Acute Myocardial Infarction: Rationale and Study Design
DANSPOT: A Multicenter Stepped‐Wedge Cluster‐Randomized Trial of the Reclassification of Acute Myocardial Infarction: Rationale and Study Design Open
Background Cardiac troponins are the preferred biomarkers for the diagnosis of acute myocardial infarction. Although sex‐specific 99th percentile thresholds of troponins are recommended in international guidelines, the clinical effect of t…
View article: Effects of sceptical priors on the performance of adaptive clinical trials with binary outcomes.
Effects of sceptical priors on the performance of adaptive clinical trials with binary outcomes. Open
It is unclear how sceptical priors impact adaptive trials. We assessed the influence of priors expressing a spectrum of scepticism on the performance of several Bayesian, multi‐stage, adaptive clinical trial designs using binary outcomes u…