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41 papers found.
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Correction: The Area of Secondary Hyperalgesia following Heat Stimulation in Healthy Male Volunteers: Inter- and Intra-Individual Variance and Reproducibility

Wetterslev Christian Bressen Pipper Rebecca Østervig Mohammad Sohail Asghar Jørgen Berg Dahl Citation: Hansen MS, Wetterslev J, Pipper CB, There is an error in the second sentence under the sub-heading

Pharmacological interventions for delirium in intensive care patients: a protocol for an overview of reviews

Background The prevalence of delirium in intensive care unit (ICU) patients is high. Delirium has been associated with morbidity and mortality including more ventilator days, longer ICU stay, increased long-term mortality and cognitive impairment. Thus, the burden of delirium for patients, relatives and societies is considerable. Today, reviews of randomised clinical trials are ...

Pharmacological interventions for delirium in intensive care patients: a protocol for an overview of reviews

Background The prevalence of delirium in intensive care unit (ICU) patients is high. Delirium has been associated with morbidity and mortality including more ventilator days, longer ICU stay, increased long-term mortality and cognitive impairment. Thus, the burden of delirium for patients, relatives and societies is considerable. Today, reviews of randomised clinical trials are ...

PANSAID – PAracetamol and NSAID in combination: study protocol for a randomised trial

Committee/ investigators. The investigators, as well as Jørn Wetterslev from CTU, have no access to the randomisation list. Safety Adverse events (AE), adverse reactions (AR), serious adverse events (SAEs

Is heat pain detection threshold associated with the area of secondary hyperalgesia following brief thermal sensitization? A study of healthy volunteers - design and detailed plan of analysis

Background Several factors are believed to influence the development and experience of pain. Human clinical pain models are central tools, in the investigation of basic physiologic pain responses, and can be applied in patients as well as in healthy volunteers. Each clinical pain model investigates different aspects of the human pain response. Brief thermal sensitization induces a ...

Associations of Hospital and Patient Characteristics with Fluid Resuscitation Volumes in Patients with Severe Sepsis: Post Hoc Analyses of Data from a Multicentre Randomised Clinical Trial

Purpose Fluid resuscitation is a key intervention in patients with sepsis and circulatory impairment. The recommendations for continued fluid therapy in sepsis are vague, which may result in differences in clinical practice. We aimed to evaluate associations between hospital and patient characteristics and fluid resuscitation volumes in ICU patients with severe sepsis. Methods We ...

The Area of Secondary Hyperalgesia following Heat Stimulation in Healthy Male Volunteers: Inter- and Intra-Individual Variance and Reproducibility

Introduction Clinical pain models can be applied when investigating basic physiologic pain responses in healthy volunteers. Several pain models exist; however, only few have been adequately validated. Our primary aim with this prospective study was to investigate the intra- and inter-individual variation in secondary hyperalgesia elicited by brief thermal sensitization (45°C for 3 ...

Milrinone for cardiac dysfunction in critically ill adult patients: a systematic review of randomised clinical trials with meta-analysis and trial sequential analysis

Introduction Milrinone is an inotrope widely used for treatment of cardiac failure. Because previous meta-analyses had methodological flaws, we decided to conduct a systematic review of the effect of milrinone in critically ill adult patients with cardiac dysfunction. Methods This systematic review was performed according to The Cochrane Handbook for Systematic Reviews of ...

Single versus Serial Measurements of Neuron-Specific Enolase and Prediction of Poor Neurological Outcome in Persistently Unconscious Patients after Out-Of-Hospital Cardiac Arrest – A TTM-Trial Substudy

Friberg Jan Hovdenes Janneke Horn Jørn Wetterslev John Bro-Jeppesen 0 Matthew P. Wise Michael Kuiper Tobias Cronberg Yvan Gasche Yvan Devaux 2 Jesper Kjaergaard 0 Stephane Legriel, Versailles Hospital

Effects of continuous prostacyclin infusion on regional blood flow and cerebral vasospasm following subarachnoid haemorrhage: statistical analysis plan for a randomized controlled trial

Background One of the main causes of mortality and morbidity following subarachnoid hemorrhage (SAH) is the development of cerebral vasospasm, a frequent complication arising in the weeks after the initial bleeding. Despite extensive research, no effective treatment of vasospasm exists to date. Prostacyclin is a potent vasodilator and inhibitor of platelet aggregation. In vitro ...

Thresholds for statistical and clinical significance in systematic reviews with meta-analytic methods

Background Thresholds for statistical significance when assessing meta-analysis results are being insufficiently demonstrated by traditional 95% confidence intervals and P-values. Assessment of intervention effects in systematic reviews with meta-analysis deserves greater rigour. Methods Methodologies for assessing statistical and clinical significance of intervention effects in ...

Intravascular versus surface cooling for targeted temperature management after out-of-hospital cardiac arrest – an analysis of the TTM trial data

Christian Hassager 5 Janneke Horn 5 Jesper Kjaergaard 5 Michael Kuiper 5 Tommaso Pellis 5 Pascal Stammet 5 Michael Wanscher 5 Jørn Wetterslev 5 Hans Friberg 5 Niklas Nielsen 5 0 Department of Critical Care

Detailed statistical analysis plan for the difficult airway management (DIFFICAIR) trial

Background Preoperative airway assessment in Denmark is based on a non-specific clinical assessment left to the discretion of the responsible anesthesiologist. The DIFFICAIR trial compares the effect of using a systematic and consistent airway assessment versus a non-specific clinical assessment on the frequency of unanticipated difficult airway management.To prevent outcome bias ...

The thresholds for statistical and clinical significance – a five-step procedure for evaluation of intervention effects in randomised clinical trials

Background Thresholds for statistical significance are insufficiently demonstrated by 95% confidence intervals or P-values when assessing results from randomised clinical trials. First, a P-value only shows the probability of getting a result assuming that the null hypothesis is true and does not reflect the probability of getting a result assuming an alternative hypothesis to the ...

Comparison of Results from Different Imputation Techniques for Missing Data from an Anti-Obesity Drug Trial

Background In randomised trials of medical interventions, the most reliable analysis follows the intention-to-treat (ITT) principle. However, the ITT analysis requires that missing outcome data have to be imputed. Different imputation techniques may give different results and some may lead to bias. In anti-obesity drug trials, many data are usually missing, and the most used ...

Incidence of unanticipated difficult airway using an objective airway score versus a standard clinical airway assessment: the DIFFICAIR trial – trial protocol for a cluster randomized clinical trial

Background Pre-operative airway assessment in Denmark is based on a non-specific clinical assessment. Systematic, evidence-based and consistent airway assessment may reduce the incidence of unanticipated difficult airway management. By assessing multiple predictors for difficult airway management, the predictive value of the assessment increases. The Simplified Airway Risk Index ...

Detailed statistical analysis plan for the pulmonary protection trial

Background Pulmonary dysfunction complicates cardiac surgery that includes cardiopulmonary bypass. The pulmonary protection trial evaluates effect of pulmonary perfusion on pulmonary function in patients suffering from chronic obstructive pulmonary disease. This paper presents the statistical plan for the main publication to avoid risk of outcome reporting bias, selective ...

Organizational Factors and Long-Term Mortality after Hip Fracture Surgery. A Cohort Study of 6143 Consecutive Patients Undergoing Hip Fracture Surgery

Objective In hospital and health care organizational factors may be changed to reduce postoperative mortality. The aim of this study is to evaluate a possible association between mortality and ‘length of hospital stay’, ‘priority of surgery’, ‘time of surgery’, or ‘surgical delay’ in hip fracture surgery. Design Observational cohort study. Setting Prospectively and consecutively ...