Aksel Karl Georg Jensen
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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: Intensive weight loss intervention versus usual care in adults with obesity: a protocol for the LightCARE randomised clinical trial
Intensive weight loss intervention versus usual care in adults with obesity: a protocol for the LightCARE randomised clinical trial Open
Introduction Total diet replacements (TDRs) and weight loss medications (WLMs) have proven effective in producing substantial weight loss for individuals with obesity. Evidence is lacking on whether combining these treatments is effective …
View article: Adaptations and Heterogeneity of Treatment Effects in Platform Trials—Protocol for Two Methodological Studies
Adaptations and Heterogeneity of Treatment Effects in Platform Trials—Protocol for Two Methodological Studies Open
Background Adaptive platform trials bring opportunities for improved infrastructure and effective advancement in medical care but are methodologically complex. Assessment of heterogeneity of treatment effects (HTE) according to participant…
View article: Understanding Social Inequalities in Childhood Asthma: Quantifying the Mediating Role of Modifiable Early-Life Risk Factors in Seven European Birth Cohorts
Understanding Social Inequalities in Childhood Asthma: Quantifying the Mediating Role of Modifiable Early-Life Risk Factors in Seven European Birth Cohorts Open
There was a consistent tendency for children from disadvantaged SECs to be at greater risk of asthma in the European cohorts examined. Our results suggest that early-life risk factors partially mediate these disparities and, therefore, tha…
View article: Rationale and design of the anticoagulant therapy after left atrial appendage closure (ATLAAC) trial
Rationale and design of the anticoagulant therapy after left atrial appendage closure (ATLAAC) trial Open
View article: <scp>INCEPT</scp>: The Intensive Care Platform Trial—Design and protocol
<span>INCEPT</span>: The Intensive Care Platform Trial—Design and protocol Open
Background Adult intensive care unit (ICU) patients receive many interventions, but few are supported by high‐certainty evidence. Randomised clinical trials (RCTs) are essential for trustworthy comparisons of intervention effects, but conv…
View article: Childhood vaccination coverages in rural Guinea-Bissau before and during the early COVID-19 pandemic, a cohort study
Childhood vaccination coverages in rural Guinea-Bissau before and during the early COVID-19 pandemic, a cohort study Open
There are no indications that the pandemic substantially changed vaccination patterns. Changes in vaccination coverages were likely driven by stock-outs rather than changes in vaccination services or health system access/demand and were no…
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: 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: Can earlier BCG-Japan and OPV vaccination reduce early infant mortality? A cluster-randomised trial in Guinea-Bissau
Can earlier BCG-Japan and OPV vaccination reduce early infant mortality? A cluster-randomised trial in Guinea-Bissau Open
Objective To assess the effect of providing BCG and oral polio vaccine (OPV) at an early home visit after delivery. Design Cluster-randomised trial, randomising 92 geographically defined clusters 1:1 to intervention/control arms. Setting B…
View article: Understanding Social Inequalities in Childhood Asthma: Quantifying the Mediating Role of Modifiable Early-Life Risk Factors in Seven Birth Cohorts in the EU Child Cohort Network
Understanding Social Inequalities in Childhood Asthma: Quantifying the Mediating Role of Modifiable Early-Life Risk Factors in Seven Birth Cohorts in the EU Child Cohort Network Open
View article: <scp>Intravenous MELAtonin</scp> for prevention of Postoperative Agitation and Emergence Delirium in children (<scp>MELA‐PAED</scp>): A protocol and statistical analysis plan for a randomized clinical trial
<span>Intravenous MELAtonin</span> for prevention of Postoperative Agitation and Emergence Delirium in children (<span>MELA‐PAED</span>): A protocol and statistical analysis plan for a randomized clinical trial Open
Background Emergence agitation and delirium in children remain a common clinical challenge in the post‐anesthetic care unit. Preoperative oral melatonin has been suggested as an effective preventive drug with a favorable safety profile. Th…
View article: Effects of duration of follow‐up and lag in data collection on the performance of adaptive clinical trials
Effects of duration of follow‐up and lag in data collection on the performance of adaptive clinical trials Open
Different combined outcome‐data lags (follow‐up durations plus data‐collection lags) may affect the performance of adaptive clinical trial designs. We assessed the influence of different outcome‐data lags (0–105 days) on the performance of…
View article: Health‐related quality of life trajectories in critical illness: Protocol for a Monte Carlo simulation study
Health‐related quality of life trajectories in critical illness: Protocol for a Monte Carlo simulation study Open
Background Health‐related quality of life (HRQoL) is a patient‐centred outcome increasingly used as a secondary outcome in critical care research. It may cover several important dimensions of clinical status in intensive care unit (ICU) pa…
View article: Use of days alive without life support and similar count outcomes in randomised clinical trials – an overview and comparison of methodological choices and analysis methods
Use of days alive without life support and similar count outcomes in randomised clinical trials – an overview and comparison of methodological choices and analysis methods Open
Background Days alive without life support (DAWOLS) and similar outcomes that seek to summarise mortality and non-mortality experiences are increasingly used in critical care research. The use of these outcomes is challenged by different d…
View article: Overall effect of a campaign with measles vaccine on the composite outcome mortality or hospital admission: A cluster-randomized trial among children aged 9-59 months in rural Guinea-Bissau
Overall effect of a campaign with measles vaccine on the composite outcome mortality or hospital admission: A cluster-randomized trial among children aged 9-59 months in rural Guinea-Bissau Open
View article: Association between days alive without life support/out of hospital and health‐related quality of life
Association between days alive without life support/out of hospital and health‐related quality of life Open
Background Trials in critically ill patients increasingly focus on days alive without life support (DAWOLS) or days alive out of hospital (DAOOH) and health‐related quality of life (HRQoL). DAWOLS and DAOOH convey more information than mor…
View article: An overview of methodological considerations regarding adaptive stopping, arm dropping, and randomization in clinical trials
An overview of methodological considerations regarding adaptive stopping, arm dropping, and randomization in clinical trials Open
This overview may help trialists design better and more transparent adaptive clinical trials and to adequately compare them before initiation.
View article: Can BCG vaccination at first health-facility contact reduce early infant mortality? Study protocol for a cluster-randomised trial (CS-BCG)
Can BCG vaccination at first health-facility contact reduce early infant mortality? Study protocol for a cluster-randomised trial (CS-BCG) Open
Introduction Increasing evidence suggests that the BCG vaccine has non-specific effects, altering the susceptibility to non-tuberculous infections. Thus, early BCG vaccination may reduce mortality. BCG is recommended at birth but is often …
View article: Interactions in the 2×2×2 factorial randomised clinical STEPCARE trial and the potential effects on conclusions: a protocol for a simulation study
Interactions in the 2×2×2 factorial randomised clinical STEPCARE trial and the potential effects on conclusions: a protocol for a simulation study Open
Background Randomised clinical trials with a factorial design may assess the effects of multiple interventions in the same population. Factorial trials are carried out under the assumption that the trial interventions have no interactions …
View article: Data for "Patient-Important Outcomes Other Than Mortality in Contemporary ICU Trials: A Scoping Review"
Data for "Patient-Important Outcomes Other Than Mortality in Contemporary ICU Trials: A Scoping Review" Open
This upload contains the final datasets analyzed in the manuscript "Patient-Important Outcomes Other Than Mortality in Contemporary ICU Trials: A Scoping Review", published in Critical Care Medicine, 2022 (https://doi.org/10.1097/CCM.00000…
View article: Data for "Patient-Important Outcomes Other Than Mortality in Contemporary ICU Trials: A Scoping Review"
Data for "Patient-Important Outcomes Other Than Mortality in Contemporary ICU Trials: A Scoping Review" Open
This upload contains the final datasets analyzed in the manuscript "Patient-Important Outcomes Other Than Mortality in Contemporary ICU Trials: A Scoping Review", published in Critical Care Medicine, 2022 (https://doi.org/10.1097/CCM.00000…
View article: adaptr: an R package for simulating and comparingadaptive clinical trials
adaptr: an R package for simulating and comparingadaptive clinical trials Open
The adaptr R package facilitates simulation and comparison of adaptive clinical trial designs using Bayesian statistical methods.The package supports a flexible number of arms, use of a common control arm, pre-specified and user-defined ou…
View article: Long-term mortality and health-related quality of life of lower versus higher oxygenation targets in ICU patients with severe hypoxaemia
Long-term mortality and health-related quality of life of lower versus higher oxygenation targets in ICU patients with severe hypoxaemia Open
View article: Health‐related quality of life and days alive without life support or out of hospital: Protocol
Health‐related quality of life and days alive without life support or out of hospital: Protocol Open
Background Mortality is often the primary outcome in randomised clinical trials (RCTs) conducted in critically ill patients. Due to increased awareness on survivors after critical illness and outcomes other than mortality, health‐related q…
View article: Usage and risk with phosphodiesterase type 5 inhibitors in male patients with chronic ischemic heart disease on oral organic nitrates
Usage and risk with phosphodiesterase type 5 inhibitors in male patients with chronic ischemic heart disease on oral organic nitrates Open
Background Combining oral organic nitrates (OON) with phosphodiesterase type 5 (PDE5) inhibitors is contraindicated. Growing and liberal use of PDE5 inhibitors for erectile dysfunction among patients with ischemic heart disease (IHD) could…
View article: Patient‐important outcomes other than mortality in recent ICU trials: Protocol for a scoping review
Patient‐important outcomes other than mortality in recent ICU trials: Protocol for a scoping review Open
Background Randomised clinical trials (RCTs) conducted in intensive care units (ICUs) frequently focus on all‐cause mortality, but other patient‐important outcomes are increasingly used and recommended. Their use, however, is not straightf…
View article: Using BCG vaccine to enhance non-specific protection of health care workers during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial in Denmark
Using BCG vaccine to enhance non-specific protection of health care workers during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial in Denmark Open
View article: Reduction in Short-term Outpatient Consultations After a Campaign With Measles Vaccine in Children Aged 9–59 Months: Substudy Within a Cluster-Randomized Trial
Reduction in Short-term Outpatient Consultations After a Campaign With Measles Vaccine in Children Aged 9–59 Months: Substudy Within a Cluster-Randomized Trial Open
Background We assessed a measles vaccination campaign’s potential short-term adverse events. Methods In a cluster-randomized trial assessing a measles vaccination campaign’s effect on all-cause mortality and hospital admission among childr…
View article: Penta is associated with an increased female-male mortality ratio: cohort study from Bangladesh
Penta is associated with an increased female-male mortality ratio: cohort study from Bangladesh Open
Diphtheria-tetanus-pertussis (DTP) vaccine may be associated with excess female deaths. There are few studies of possible nonspecific effects of the DTP-containing vaccine Penta (DTP-hepatitis B-Haemophilus influenzae type b)…