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Search Results: 1 - 10 of 14741 matches for " Christian Gluud "
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Likely country of origin in publications on randomised controlled trials and controlled clinical trials during the last 60 years
Christian Gluud, Dimitrinka Nikolova
Trials , 2007, DOI: 10.1186/1745-6215-8-7
Abstract: We searched the 454,449 records on publications in The Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, Issue 3, 2005 (CD-ROM version) for possible country of origin. We inspected a random sample of 906 records for information on country and type of trial.There was an exponential growth of publications on randomised controlled trials and controlled clinical trials since 1946, but the growth seems to have seized since 2000. We identified the possible country of origin of 210,974 publications (46.4%). The USA is leading with about 46,789 publications followed by UK, Germany, Italy, the Netherlands, Canada, and France. Sweden becomes the leader with 891 publications per million inhabitants during the last 60 years followed by Denmark (n = 864), New Zealand (n = 791), Finland (n = 781), the Netherlands (n = 570), Switzerland (n = 547), and Norway (n = 543). In depth assessment of the random sample backed these findings.Many records lacked country of origin, even after the additional scrutiny. The number of publications on clinical trials increased exponentially until the turn of the century. Rather small, democratic, and wealthy countries take the lead when the number of publications on clinical trials is calculated based on million inhabitants. If all countries produced the same number of trials as these countries, this could mean thousands of new effective treatments during the next 60 years.On the 20th of May 1747, the Scottish naval surgeon James Lind started his controlled clinical trial of six interventions for scurvy patients [1]. The results were published in 1753 in his Treatise of the Scurvy [1]. Early examples of randomised, placebo-controlled trials date back to the Nuremberg salt trial from 1835 [2]. Physicians took their time. The whole idea of randomised controlled trials was first more widely accepted at the end of the Second World War [3]. Since then hundred thousands of clinical trials have been conducted all over the w
Christian Gluud,Dimitrinka Nikolova
Acta Facultatis Medicae Naissensis , 2008,
Abstract: The article gives an overview of the structure, aims, products, and achievements of The Cochrane Hepato-Biliary Group (CHBG) in its 12th-year of existence. The article informs about the process of systematic review preparation, the central role of randomised clinical trials for making evidence-based decisions on benefits and harms of interventions, and discusses factors that may lead to biased evaluation of the studied interventions. Systematic reviews are mostly based on meta-analyses of randomised clinical trials. The importance of methodological evaluation of trial reports using a number of components that may detect systematic errors ('bias') is discussed. 'Trials sequential analysis' as a way to control risk of random errors ('play of chance') due to repetitive testing on accumulating data in cumulative meta-analyses is introduced. The CHBG reviews are published in The Cochrane Library as well as in paper journals. The practice to look for or conduct a systematic review be-fore planning a clinical trial or write a clinical guideline should become routine.
Meta-Regression Analyses, Meta-Analyses, and Trial Sequential Analyses of the Effects of Supplementation with Beta-Carotene, Vitamin A, and Vitamin E Singly or in Different Combinations on All-Cause Mortality: Do We Have Evidence for Lack of Harm?
Goran Bjelakovic, Dimitrinka Nikolova, Christian Gluud
PLOS ONE , 2013, DOI: 10.1371/journal.pone.0074558
Abstract: Background and Aims Evidence shows that antioxidant supplements may increase mortality. Our aims were to assess whether different doses of beta-carotene, vitamin A, and vitamin E affect mortality in primary and secondary prevention randomized clinical trials with low risk of bias. Methods The present study is based on our 2012 Cochrane systematic review analyzing beneficial and harmful effects of antioxidant supplements in adults. Using random-effects meta-analyses, meta-regression analyses, and trial sequential analyses, we examined the association between beta-carotene, vitamin A, and vitamin E, and mortality according to their daily doses and doses below and above the recommended daily allowances (RDA). Results We included 53 randomized trials with low risk of bias (241,883 participants, aged 18 to 103 years, 44.6% women) assessing beta-carotene, vitamin A, and vitamin E. Meta-regression analysis showed that the dose of vitamin A was significantly positively associated with all-cause mortality. Beta-carotene in a dose above 9.6 mg significantly increased mortality (relative risk (RR) 1.06, 95% confidence interval (CI) 1.02 to 1.09, I2 = 13%). Vitamin A in a dose above the RDA (> 800 μg) did not significantly influence mortality (RR 1.08, 95% CI 0.98 to 1.19, I2 = 53%). Vitamin E in a dose above the RDA (> 15 mg) significantly increased mortality (RR 1.03, 95% CI 1.00 to 1.05, I2 = 0%). Doses below the RDAs did not affect mortality, but data were sparse. Conclusions Beta-carotene and vitamin E in doses higher than the RDA seem to significantly increase mortality, whereas we lack information on vitamin A. Dose of vitamin A was significantly associated with increased mortality in meta-regression. We lack information on doses below the RDA. Background All essential compounds to stay healthy cannot be synthesized in our body. Therefore, these compounds must be taken through our diet or obtained in other ways [1]. Oxidative stress has been suggested to cause a variety of diseases [2]. Therefore, it is speculated that antioxidant supplements could have a potential role in preventing diseases and death. Despite the fact that a normal diet in high-income countries may provide sufficient amounts of antioxidants [3,4], more than one third of adults regularly take antioxidant supplements [5,6].
The Effect of Interpersonal Psychotherapy and other Psychodynamic Therapies versus ‘Treatment as Usual’ in Patients with Major Depressive Disorder
Janus Christian Jakobsen,Jane Lindschou Hansen,Erik Simonsen,Christian Gluud
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0019044
Abstract: Major depressive disorder afflicts an estimated 17% of individuals during their lifetimes at tremendous suffering and costs. Interpersonal psychotherapy and other psychodynamic therapies may be effective interventions for major depressive disorder, but the effects have only had limited assessment in systematic reviews.
DEMO-II Trial. Aerobic Exercise versus Stretching Exercise in Patients with Major Depression—A Randomised Clinical Trial
Jesper Krogh, Poul Videbech, Carsten Thomsen, Christian Gluud, Merete Nordentoft
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0048316
Abstract: Background The effect of referring patients from a clinical setting to a pragmatic exercise intervention for depressive symptoms, cognitive function, and metabolic variables has yet to be determined. Methods Outpatients with major depression (DSM-IV) were allocated to supervised aerobic or stretching exercise groups during a three months period. The primary outcome was the Hamilton depression score (HAM-D17). Secondary outcomes were cognitive function, cardiovascular risk markers, and employment related outcomes. Results 56 participants were allocated to the aerobic exercise intervention versus 59 participants to the stretching exercise group. Post intervention the mean difference between groups was ?0.78 points on the HAM-D17 (95% CI ?3.2 to 1.6; P = .52). At follow-up, the participants in the aerobic exercise group had higher maximal oxygen uptake (mean difference 4.4 l/kg/min; 95% CI 1.7 to 7.0; P = .001) and visuospatial memory on Rey’s Complex Figure Test (mean difference 3.2 points; 95% CI 0.9 to 5.5; P = .007) and lower blood glucose levels (mean difference 0.2 mmol/l; 95% CI 0.0 to 0.5; P = .04) and waist circumference (mean difference 2.2 cm; 95% CI 0.3 to 4.1; P = .02) compared with the stretching exercise group. Conclusions The results of this trial does not support any antidepressant effect of referring patients with major depression to a three months aerobic exercise program. Due to lower recruitment than anticipated, the trial was terminated prior to reaching the pre-defined sample size of 212 participants; therefore the results should be interpreted in that context. However, the DEMO-II trial does suggest that an exercise program for patients with depression offer positive short-term effects on maximal oxygen uptake, visuospatial memory, fasting glucose levels, and waist circumference. Trial Registration ClinicalTrials.gov NCT00695552
Social-Skills and Parental Training plus Standard Treatment versus Standard Treatment for Children with ADHD – The Randomised SOSTRA Trial
Ole Jakob Storeb?, Christian Gluud, Per Winkel, Erik Simonsen
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0037280
Abstract: Objective To investigate the effects of social-skills training and parental training programme for children with attention deficit hyperactivity disorder (ADHD). Methods We conducted a randomized two-armed, parallel group, assessor-blinded superiority trial consisting of social-skills training plus parental training and standard treatment versus standard treatment alone. A sample size calculation showed at least 52 children should be included for the trial with follow up three and six months after randomization. The primary outcome measure was ADHD symptoms and secondary outcomes were social skills and emotional competences. Results 56 children (39 boys, 17 girls, mean age 10.4 years, SD 1.31) with ADHD were randomized, 28 to the experimental group and 27 to the control group. Mixed-model analyses with repeated measures showed that the time course (y = a + bt + ct2) of ADHD symptoms (p = 0.40), social skills (p = 0.80), and emotional competences (p = 0.14) were not significantly influenced by the intervention. Conclusions Social skills training plus parental training did not show any significant benefit for children with attention deficit hyperactivity disorder when compared with standard treatment. More and larger randomized trials are needed. Trial Registration ClinicalTrials.gov NCT00937469
The Hand Eczema Trial (HET): design of a randomised clinical trial of the effect of classification and individual counselling versus no intervention among health-care workers with hand eczema
Kristina Ibler, Tove Agner, Jane Hansen, Christian Gluud
BMC Dermatology , 2010, DOI: 10.1186/1471-5945-10-8
Abstract: We describe the design of a randomised clinical trial to investigate the effects of classification of hand eczema plus individual counselling versus no intervention. The trial includes health-care workers with hand eczema identified from a self-administered questionnaire delivered to 3181 health-care workers in three Danish hospitals. The questionnaire identifies the prevalence of hand eczema, knowledge of skin-protection, and exposures that can lead to hand eczema. At entry, all participants are assessed regarding: disease severity (Hand Eczema Severity Index); self-evaluated disease severity; number of eruptions; quality of life; skin protective behaviour, and knowledge of skin protection. The patients are centrally randomised to intervention versus no intervention 1:1 stratified for hospital, profession, and severity score. The experimental group undergoes patch and prick testing; classification of the hand eczema; demonstration of hand washing and appliance of emollients; individual counselling, and a skin-care programme. The control group receives no intervention. All participants are reassessed after six months. The primary outcome is observer-blinded assessment of disease severity and the secondary outcomes are unblinded assessments of disease severity; number of eruptions; knowledge of skin protection; skin-protective behaviour, and quality of life.The trial is registered in ClinicalTrials.Gov, NCT01012453.Hand eczema (HE) is a long-lasting disease with a point prevalence of 9.7% in the background population [1] and an incidence reported to be 5.5 to 8.8 per 1000 person-years [2,3]. Occupational hand eczema (OHE) is the most frequently recognized occupational disease in Denmark with an incidence of approximately 0.32 per 1000 person-years [4]. Other studies have revealed that the annual incidence of new reports of occupational skin diseases is 0.7 to 0.8 per 1,000 employees [5,3] and the number of unreported occupational skin conditions are many times greate
Estimating required information size by quantifying diversity in random-effects model meta-analyses
J?rn Wetterslev, Kristian Thorlund, Jesper Brok, Christian Gluud
BMC Medical Research Methodology , 2009, DOI: 10.1186/1471-2288-9-86
Abstract: Information size calculations need to consider the total model variance in a meta-analysis to control type I and type II errors. Here, we derive an adjusting factor for the required information size under any random-effects model meta-analysis.We devise a measure of diversity (D2) in a meta-analysis, which is the relative variance reduction when the meta-analysis model is changed from a random-effects into a fixed-effect model. D2 is the percentage that the between-trial variability constitutes of the sum of the between-trial variability and a sampling error estimate considering the required information size. D2 is different from the intuitively obvious adjusting factor based on the common quantification of heterogeneity, the inconsistency (I2), which may underestimate the required information size. Thus, D2 and I2 are compared and interpreted using several simulations and clinical examples. In addition we show mathematically that diversity is equal to or greater than inconsistency, that is D2 ≥ I2, for all meta-analyses.We conclude that D2 seems a better alternative than I2 to consider model variation in any random-effects meta-analysis despite the choice of the between trial variance estimator that constitutes the model. Furthermore, D2 can readily adjust the required information size in any random-effects model meta-analysis.Outcome measures in a single randomised trial or a meta-analysis of several randomised trials are typically dichotomous, especially for important clinical outcomes such as death, acute myocardial infarction, etc. Although meta-analysts cannot directly influence the number of participants in a meta-analysis like trialists conducting a single trial, the assessment of the meta-analytic result depends heavily on the amount of information provided. A limited number of events from a few small trials and the associated random error may be under-recognised sources of spurious findings. If a meta-analysis is conducted before reaching a required inform
The Effects of Cognitive Therapy versus ‘No Intervention’ for Major Depressive Disorder
Janus Christian Jakobsen,Jane Lindschou Hansen,Ole Jakob Storeb?,Erik Simonsen,Christian Gluud
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0028299
Abstract: Major depressive disorder afflicts an estimated 17% of individuals during their lifetimes at tremendous suffering and costs. Cognitive therapy may be an effective treatment option for major depressive disorder, but the effects have only had limited assessment in systematic reviews.
The Effects of Cognitive Therapy Versus ‘Treatment as Usual’ in Patients with Major Depressive Disorder
Janus Christian Jakobsen,Jane Lindschou Hansen,Ole Jakob Storeb?,Erik Simonsen,Christian Gluud
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0022890
Abstract: Major depressive disorder afflicts an estimated 17% of individuals during their lifetimes at tremendous suffering and costs. Cognitive therapy may be an effective treatment option for major depressive disorder, but the effects have only had limited assessment in systematic reviews.
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