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Dragancea I.,Lund University | Kuiper M.,Medical Center Leeuwarden | Friberg H.,Lund University | Ullen S.,Skane University Hospital | And 5 more authors.

Background: The reliability of some methods of neurological prognostication after out-of-hospital cardiac arrest has been questioned since the introduction of induced hypothermia. The aim of this study was to determine whether different treatment temperatures after resuscitation affected the prognostic accuracy of clinical neurological findings and somatosensory evoked potentials (SSEP) in comatose patients. Methods: We calculated sensitivity and false positive rate for Glasgow Coma Scale motor score (GCS M), pupillary and corneal reflexes and SSEP to predict poor neurological outcome using prospective data from the Target Temperature Management after Out-of-Hospital Cardiac Arrest Trial which randomised 939 comatose survivors to treatment at either 33. °C or 36. °C. Poor outcome was defined as severe disability, vegetative state or death (Cerebral Performance Category scale 3-5) at six months. Results: 313 patients (33%) were prognostically assessed; 168 in the 33. °C, and 145 in the 36. °C group. A GCS M ≤2 had a false positive rate of 19.1% to predict poor outcome due to nine false predictions. Bilaterally absent pupillary reflexes had a false positive rate of 2.1% and absent corneal reflexes had a false positive rate of 2.2% due to one false prediction in each group. The false positive rate for bilaterally absent SSEP N20-peaks was 2.6%. Conclusions: Bilaterally absent pupillary and corneal reflexes and absent SSEP N20-peaks were reliable markers of a poor prognosis after resuscitation from out-of-hospital cardiac arrest but low GCS M score was not. The reliability of the tests was not altered by the treatment temperature. © 2015 Elsevier Ireland Ltd. Source

Brok J.,Copenhagen University | Huusom L.D.,Copenhagen University | Thorlund K.,Copenhagen Trial Unit | Thorlund K.,McMaster University
Acta Obstetricia et Gynecologica Scandinavica

Results from meta-analyses significantly influence clinical practice. Both simulation and empirical studies have demonstrated that the risk of random error (i.e. spurious chance findings) in meta-analyses is much higher than previously anticipated. Hence, authors and users of systematic reviews and meta-analyses have a responsibility to carefully consider the risk of random errors to avoid misleading conclusions. Trial sequential analysis is a useful meta-analytic method for gauging the risk of random error in meta-analysis and the amount of additional evidence required to reach firm conclusions about the investigated intervention effect(s). We outline the rationale for conducting trial sequential analysis including some examples of the meta-analysis on antenatal magnesium for women at risk of preterm birth. © 2012 The Authors Acta Obstetricia et Gynecologica Scandinavica© 2012 Nordic Federation of Societies of Obstetrics and Gynecology. Source

Chatterjee S.,Brown University | Wetterslev J.,Copenhagen Trial Unit | Sharma A.,Maimonides Medical Center | Lichstein E.,Maimonides Medical Center | Mukherjee D.,Texas Tech University
JAMA Internal Medicine

Background: The benefit of blood transfusion in patients with myocardial infarction is controversial, and a possibility of harm exists. Methods: A systematic search of studies published between January 1, 1966, and March 31, 2012, was conducted using MEDLINE, EMBASE, CINAHL, Scopus, Web of Science, and Cochrane Central Register of Controlled Trials databases. English-language studies comparing blood transfusion with no blood transfusion or a liberal vs restricted blood transfusion strategy were identified. Two study authors independently reviewed 729 originally identified titles and abstracts and selected 10 for analysis. Study title, follow-up period, blood transfusion strategy, and mortality outcomes were extracted manually from all selected studies, and the quality of each study was assessed using the strengthening Meta-analysis of Observational Studies in Epidemiology checklist. Results: Studies of blood transfusion strategy in anemia associated with myocardial infarction were abstracted, as well as all-cause mortality rates at the longest available follow-up periods for the individual studies. Pooled effect estimates were calculated with random-effects models. Analyses of blood transfusion in myocardial infarction revealed increased all-cause mortality associated with a strategy of blood transfusion vs no blood transfusion during myocardial infarction (18.2% vs 10.2%) (risk ratio, 2.91;95% CI, 2.46-3.44; P<.001), with a weighted absolute risk increase of 12% and a number needed to harm of 8 (95% CI, 6-17). Multivariate meta-regression revealed that blood transfusion was associated with a higher risk for mortality independent of baseline hemoglobin level, nadir hemoglobin level, and change in hemoglobin level during the hospital stay. Blood transfusion was also significantly associated with a higher risk for subsequent myocardial infarction (risk ratio, 2.04;95% CI, 1.06-3.93; P =.03). Conclusions: Blood transfusion or a liberal blood transfusion strategy compared with no blood transfusion or a restricted blood transfusion strategy is associated with higher all-cause mortality rates. A practice of routine or liberal blood transfusion in myocardial infarction should not be encouraged but requires investigation in a large trial with low risk for bias. © 2013 American Medical Association. Source

Hjorthoj C.R.,Copenhagen University | Fohlmann A.,Copenhagen University | Larsen A.-M.,Copenhagen University | Gluud C.,Copenhagen Trial Unit | And 2 more authors.
Psychological Medicine

Background Cannabis abuse in psychotic patients is associated with rehospitalizations, reduced adherence and increased symptom severity. Previous psychosocial interventions have been ineffective in cannabis use, possibly because of low sample sizes and short interventions. We investigated whether adding CapOpus to treatment as usual (TAU) reduces cannabis use in patients with cannabis use disorder and psychosis. Method A total of 103 patients with psychosis and cannabis use disorder were centrally randomized to 6 months of CapOpus plus TAU (n = 52) or TAU (n = 51). CapOpus consisted mainly of motivational interviewing and cognitive behaviour therapy (CBT). TAU was targeted primarily at the psychotic disorder. The primary outcome was self-reported days with cannabis use in the preceding month. Results Pre-randomization cannabis use frequency was 14.9 [95% confidence interval (CI) 12.7-17.1] days/month. Post-treatment, the ratio of days/month with cannabis use in CapOpus versus TAU was 0.76 (95% CI 0.38-1.50) (p = 0.42), and 0.80 (95% CI 0.21-3.10) (p = 0.75) at the 4-month follow-up. From 46.4 (95% CI 36.4-56.3) monthly joints pre-randomization, consumption fell to 27.3 (95% CI 12.6-41.9) joints in CapOpus and 48.2 (95% CI 31.8-64.6) in TAU (p = 0.06). Follow-up amounts were 28.4 (95% CI 13.5-43.2) and 41.6 (95% CI 25.2-58.0) joints (p = 0.23). Several subgroup analyses suggested benefits of CapOpus. Conclusions CapOpus did not reduce the frequency, but possibly the amount, of cannabis use. This is similar to the findings of previous trials in this population. Implementation of CapOpus-type interventions is thus not warranted at present but subgroup analyses call for further trials. © 2012 Cambridge University Press. Source

Hogdal N.,Copenhagen University | Juhl C.,University of Southern Denmark | Juhl C.,Copenhagen University | Aadahl M.,Research Center for Prevention and Health | Gluud C.,Copenhagen Trial Unit
Acta Oncologica

Purpose. In head and neck cancer patients undergoing curative radiotherapy, we investigated the benefits and harms of an early exercise regime on trismus. Material and methods. Patients with head and neck cancer undergoing radiotherapy were centrally randomised to exercises 5-6 times for 45 minutes during and after radiotherapy supervised by a physiotherapist in addition to usual care versus usual care alone. The primary outcome was change in maximal interincisor distance (MID) measured at 5 and 12 months. Secondary outcomes were change in cervical ranges of motion, tissue tightness, and health-related quality of life. Mixed model analysis of repeated measures adjusted for tumour size and operation was conducted to assess the effect of early preventive exercises across time periods. Results. Of the 100 patients included, two patients withdrew and one died before the onset of radiotherapy. The unadjusted mean difference in MID at 12 months after having completed radiotherapy was 0.83 mm (95% confidence interval (CI) -3.64-5.29, p = 0.71) in the exercise intervention group compared with the control group. When adjusted for operation and tumour size, the effect of the exercise intervention on mean MID from baseline to 12-month follow-up was 5.92 mm (95% CI -0.48-12.33, p = 0.07). Of the secondary outcomes, cervical rotation showed a statistically significant deterioration in the exercise group compared with the control group (p = 0.01). No significant effects were observed on the other secondary outcomes. Conclusions. In patients with cancer in the oral cavity or oropharynx, early supervised exercises combined with self-care treatment focusing on mobility exercises to reduce trismus do not seem to provide additional beneficial effects compared with usual care during curative radiotherapy. © 2015 Informa Healthcare. Source

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