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Many pain scales are used post‐operatively in pediatric trials, making the comparison of trials, and the pooling of data for meta‐analyses difficult. The Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials... more
Many pain scales are used post‐operatively in pediatric trials, making the comparison of trials, and the pooling of data for meta‐analyses difficult. The Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (PedIMMPACT) statement, published in 2008, attempted to address this issue. We aimed to investigate the reasons for authors’ choice of pain scales and the potential impact of PedIMMPACT.
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Research Interests: Psychology, Ethics, Applied Ethics, Anesthesiology, Research Ethics, and 15 morePhilosophy of Medicine, Research, Medicine, Authorship, Social Control, Humans, Disclosure, Europe, Editorial Policies, Records, Cross Sectional Studies, Ethics Committees, Surveys and Questionnaires, ethical review, and publishing ethics
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Patients undergoing emergency procedures under general anesthesia have impaired gastric emptying and are at high risk for aspiration of gastric contents. Erythromycin has strong gastric prokinetic properties. To evaluate the efficacy of... more
Patients undergoing emergency procedures under general anesthesia have impaired gastric emptying and are at high risk for aspiration of gastric contents. Erythromycin has strong gastric prokinetic properties. To evaluate the efficacy of erythromycin lactobionate in gastric emptying in patients undergoing emergency surgery. The Erythro-Emerge trial was a single-center, randomized, double-blinded, placebo-controlled clinical trial in patients undergoing emergency surgery under general anesthesia at Geneva University Hospitals. We included 132 patients from March 25, 2009, through April 10, 2013, and all patients completed the study. Randomization was stratified for trauma and nontrauma procedures. The randomization code was opened on April 23, 2013, and analyses were performed through July 26, 2013. We performed an intention-to-treat analysis. Patients were randomized to intravenous erythromycin lactobionate, 3 mg/kg, or placebo 15 minutes before tracheal intubation. Patients were fol...
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To examine whether, according to the conclusions of a 2000 systematic review with meta-analysis on interventions to prevent pain from propofol injection that provided a research agenda to guide further research on the topic, subsequently... more
To examine whether, according to the conclusions of a 2000 systematic review with meta-analysis on interventions to prevent pain from propofol injection that provided a research agenda to guide further research on the topic, subsequently published trials were more often optimally blinded, reported on children, and used the most efficacious intervention as comparator; and to check whether the number of new trials published each year had decreased and whether the designs of trials that cited the review differed from those that did not. Systematic review comparing old trials (published before, and included in, the review) with new trials (published afterwards). Medline, Cochrane, Embase, and bibliographies to January 2013. Randomised studies testing any intervention to prevent pain from propofol injection in humans. 136 new trials (19,778 patients) were retrieved. Compared with the 56 old trials (6264 patients), the proportion of optimally blinded trials had increased from 10.7% to 38....
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Waeber, Baptiste, Bengt Kayser, Lionel Dumont, Christopher Lysakowski, Martin R. Tramèr, and Nadia Elia. Impact of study design on reported incidences of acute mountain sickness: A systematic review. High Alt Med Biol 16:204-215, 2015.-... more
Waeber, Baptiste, Bengt Kayser, Lionel Dumont, Christopher Lysakowski, Martin R. Tramèr, and Nadia Elia. Impact of study design on reported incidences of acute mountain sickness: A systematic review. High Alt Med Biol 16:204-215, 2015.- Published incidences of acute mountain sickness (AMS) vary widely. Reasons for this variation, and predictive factors of AMS, are not well understood. We aimed to identify predictive factors that are associated with the occurrence of AMS, and to test the hypothesis that study design is an independent predictive factor of AMS incidence. We did a systematic search (Medline, bibliographies) for relevant articles in English or French, up to April 28, 2013. Studies of any design reporting on AMS incidence in humans without prophylaxis were selected. Data on incidence and potential predictive factors were extracted by two reviewers and crosschecked by four reviewers. Associations between predictive factors and AMS incidence were sought through bivariate and multivariate analyses for different study designs separately. Association between AMS incidence and study design was assessed using multiple linear regression. We extracted data from 53,603 subjects from 34 randomized controlled trials, 44 cohort studies, and 33 cross-sectional studies. In randomized trials, the median of AMS incidences without prophylaxis was 60% (range, 16%-100%); mode of ascent and population were significantly associated with AMS incidence. In cohort studies, the median of AMS incidences was 51% (0%-100%); geographical location was significantly associated with AMS incidence. In cross-sectional studies, the median of AMS incidences was 32% (0%-68%); mode of ascent and maximum altitude were significantly associated with AMS incidence. In a multivariate analysis, study design (p=0.012), mode of ascent (p=0.003), maximum altitude (p<0.001), population (p=0.002), and geographical location (p<0.001) were significantly associated with AMS incidence. Age, sex, speed of ascent, duration of exposure, or history of AMS were inconsistently reported and therefore not further analyzed. Reported incidences and identifiable predictive factors of AMS depend on study design.
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Ketamine, an N-methyl-D-aspartate receptor antagonist, is known to be analgesic and to induce psychomimetic effects. Benefits and risks of ketamine for the control of postoperative pain are not well understood. We systematically searched... more
Ketamine, an N-methyl-D-aspartate receptor antagonist, is known to be analgesic and to induce psychomimetic effects. Benefits and risks of ketamine for the control of postoperative pain are not well understood. We systematically searched for randomised comparisons of ketamine with inactive controls in surgical patients, reporting on pain outcomes, opioid sparing, and adverse effects. Data were combined using a fixed effect model. Fifty-three trials (2839 patients) from 25 countries reported on a large variety of different ketamine regimens and surgical settings. Sixteen studies tested prophylactic intravenous ketamine (median dose 0.4 mg/kg, range (0.1-1.6)) in 850 adults. Weighted mean difference (WMD) for postoperative pain intensity (0-10 cm visual analogue scale) was -0.89 cm at 6 h, -0.42 at 12 h, -0.35 at 24 h and -0.27 at 48 h. Cumulative morphine consumption at 24 h was significantly decreased with ketamine (WMD -15.7 mg). There was no difference in morphine-related adverse effects. The other 37 trials tested in adults or children, prophylactic or therapeutic ketamine orally, intramuscularly, subcutaneously, intra-articulary, caudally, epidurally, transdermally, peripherally or added to a PCA device; meta-analyses were deemed inappropriate. The highest risk of hallucinations was in awake or sedated patients receiving ketamine without benzodiazepine; compared with controls, the odds ratio (OR) was 2.32 (95%CI, 1.09-4.92), number-needed-to-harm (NNH) 21. In patients undergoing general anaesthesia, the incidence of hallucinations was low and independent of benzodiazepine premedication; OR 1.49 (95%CI 0.18-12.6), NNH 286. Despite many published randomised trials, the role of ketamine, as a component of perioperative analgesia, remains unclear.
Research Interests: Pain, Risk, Humans, Child, Hallucinations, and 14 moreKetamine, Medline, Postoperative pain, Adult, Time Factors, Age Factors, Reproducibility of Results, Pain Measurement, Analgesics, Randomized Controlled Trials as Topic, postoperative nausea and vomiting, Psychology and Cognitive Sciences, Weights and measures, and Medical and Health Sciences
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To study whether systematic reviewers apply procedures to counter-balance some common forms of research malpractice such as not publishing completed research, duplicate publications, or selective reporting of outcomes, and to see whether... more
To study whether systematic reviewers apply procedures to counter-balance some common forms of research malpractice such as not publishing completed research, duplicate publications, or selective reporting of outcomes, and to see whether they identify and report misconduct. Cross-sectional analysis of systematic reviews and survey of their authors. 118 systematic reviews published in four journals (Ann Int Med, BMJ, JAMA, Lancet), and the Cochrane Library, in 2013. Number (%) of reviews that applied procedures to reduce the impact of: (1) publication bias (through searching of unpublished trials), (2) selective outcome reporting (by contacting the authors of the original studies), (3) duplicate publications, (4) sponsors' and (5) authors' conflicts of interest, on the conclusions of the review, and (6) looked for ethical approval of the studies. Number (%) of reviewers who suspected misconduct are reported. The procedures applied were compared across journals. 80 (68%) reviewers confirmed their data. 59 (50%) reviews applied three or more procedures; 11 (9%) applied none. Unpublished trials were searched in 79 (66%) reviews. Authors of original studies were contacted in 73 (62%). Duplicate publications were searched in 81 (69%). 27 reviews (23%) reported sponsors of the included studies; 6 (5%) analysed their impact on the conclusions of the review. Five reviews (4%) looked at conflicts of interest of study authors; none of them analysed their impact. Three reviews (2.5%) looked at ethical approval of the studies. Seven reviews (6%) suspected misconduct; only 2 (2%) reported it explicitly. Procedures applied differed across the journals. Only half of the systematic reviews applied three or more of the six procedures examined. Sponsors, conflicts of interest of authors and ethical approval remain overlooked. Research misconduct is sometimes identified, but rarely reported. Guidance on when, and how, to report suspected misconduct is needed.
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BackgroundChanges in health-related quality of life (HRQoL) several days after surgery have rarely been investigated. We aimed to estimate the perioperative change of HRQoL, to identify patients with clinically relevant decrease in... more
BackgroundChanges in health-related quality of life (HRQoL) several days after surgery have rarely been investigated. We aimed to estimate the perioperative change of HRQoL, to identify patients with clinically relevant decrease in postoperative HRQoL and to establish factors associated with this decrease in HRQoL at day 30 after major surgery.MethodsPatients scheduled for major surgery at a university hospital were enrolled. Based on the HRQoL SF-12 questionnaire, the preoperative physical component summary (PCS) score, preoperative mental component summary (MCS) score, and postoperative PCS and MCS scores at day 30 were recorded. Minimal clinically important difference (MCID) was defined as those with a decrease of at least one half of the standard deviation (SD) of preoperative PCS or MCS scores. Differences between the groups with or without decreased HRQoL were investigated using univariate comparisons. A multiple logistic regression model was performed to evaluate the predictive value of potential perioperative variables.ResultsThe mean¿±¿SD preoperative PCS score was 38.5¿±¿10.6, postoperative score was 35.1¿±¿7.8 (p¿=¿.004) in 85 patients. Thirty-five patients (41.2%) had a clinically relevant decrease of the postoperative PCS score. A normal to high preoperative exercise metabolic capacity measured with metabolic equivalent of task (MET) (p¿=¿.01) was a predictor of the decrease in postoperative PCS. The mean preoperative MCS scores (p¿=¿.395) were 42.2 (SD 12.8) preoperative, and 43.45 (SD 12.4) postoperative, respectively.ConclusionsMajor surgery decreases postoperative PCS scores of HRQoL at 30 days. A normal to high exercise capacity was a predictor of a clinically relevant decrease of postoperative PCS scores.Trial registration07¿107 (Ethical Committee NAC of Geneva University Hospitals).
Research Interests: Quality of life, General Surgery, Prospective studies, Humans, Female, and 13 moreMale, Switzerland, Postoperative pain, Aged, Middle Aged, Public health systems and services research, Psychological Models, Logistic Models, Preoperative Period, Cohort Studies, Postoperative Period, Postoperative Complications, and Surveys and Questionnaires
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We tested whether the combination of a reduced dose of a local anesthetic (LA) with an opioid compared with a standard dose of the same LA alone guaranteed adequate intraoperative anesthesia and postoperative analgesia and decreased... more
We tested whether the combination of a reduced dose of a local anesthetic (LA) with an opioid compared with a standard dose of the same LA alone guaranteed adequate intraoperative anesthesia and postoperative analgesia and decreased LA-related adverse effects. We systematically searched (to November 2012) for randomized comparisons of combinations of a reduced dose of an LA with a concomitant opioid (experimental) with a standard dose of the LA alone (control) in adults undergoing surgery with single-injection intrathecal anesthesia without general anesthesia. We included 28 trials (1393 patients). In experimental groups, the median decrease in LA doses was 40% (range, 12%-70%). There was no difference between experimental and control groups in the need for intraoperative opioids or general anesthesia for failed block or in the duration of postoperative analgesia. With experimental interventions, there was evidence of a reduction in the duration of motor blockade postoperatively (average, -50 minutes), time to discharge from hospital or PACU (-33 minutes), time to ambulation (-28 minutes), and time to urination (-14 minutes). There was also evidence of a decrease in the risk of shivering (risk ratio [RR]: 0.26; 95% confidence interval [CI]: 0.12-0.56), nausea (RR: 0.45; 95% CI: 0.31-0.66), and arterial hypotension (RR: 0.52; 95% CI: 0.35-0.78). The risk of pruritus was increased (RR: 11.7; 95% CI: 6.2-21.9). Adding an opioid to a reduced dose of an intrathecal LA can decrease LA-related adverse effects and improve recovery from the spinal block without compromising intraoperative anesthesia or duration of postoperative analgesia.
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In patients who experience sudden death from spontaneous subarachnoid hemorrhage, more than 90% present with acute pulmonary edema. The underlying pathogenesis of this complication is poorly understood. In addition, the specific role of... more
In patients who experience sudden death from spontaneous subarachnoid hemorrhage, more than 90% present with acute pulmonary edema. The underlying pathogenesis of this complication is poorly understood. In addition, the specific role of the extravasated blood products and the associated elevation in intracranial pressure leading to the systemic and pulmonary effects during subarachnoid hemorrhage are not well established. The authors tested a new model of acute and severe subarachnoid hemorrhage comparing fresh whole autologous blood (n = 20) with 5% albumin (n = 19) injected at two different rates (35 seconds versus 24 minutes) into the cisterna magna of anesthetized, mechanically ventilated rats. Cerebral and systemic hemodynamics and the corresponding pulmonary function were evaluated. The type of fluid injected had no influence on survival or hemodynamic and respiratory parameters. Rapid infusion of either blood or albumin (n = 14) produced an acute and transient rise in intracranial pressure (37.9 +/- 3.5 mm Hg) associated with systemic hypertension and increased cerebral perfusion pressure that was sustained in survivors but not in nonsurvivors. Slow infusion (n = 23) produced a more progressive increase in intracranial pressure to 31.2 +/- 7.1 mm Hg with a parallel and sustained increase of systemic blood pressure and preserved cerebral perfusion pressure in survivors, but produced a pattern of more severe hypertension followed by hypotension in nonsurvivors. Sixty-four percent of animals (rapid infusion) and 48% of animals (slow infusion) survived the challenge and presented no pulmonary alterations. In contrast, nonsurviving rats developed reduced lung compliance and gas exchange, an increased alveolar-arterial protein concentration ratio (0.36 +/- 0.02 versus 0.17 +/- 0.03 in survivors; P <.0001), and increased lung weight (5.7 +/- 0.3 g versus 2.0 +/- 0.1 g; P <.0001), demonstrating a fulminant increased permeability pulmonary edema, leading to death within one hour. These results indicate that the chosen rapid- and slow-injection rates resulted in a similar death rate of 50%. Mortality was similar for blood and albumin administration, pulmonary edema occurred in nonsurvivors in both the rapid- and slow-injection groups, and pulmonary edema is associated with more severe hypertension in the slow-injection group. Furthermore, these results suggest that the development of neurogenic pulmonary edema that is characterized by an acutely increased capillary permeability to proteins is independent of the degree of intracranial pressure increase or the type of fluid administrated.
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Research Interests: Dexamethasone, Humans, Female, Male, Postoperative Hemorrhage, and 3 moreTonsillectomy, Antiemetics, and JAMA
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Droperidol is widely used for the prevention of postoperative nausea and vomiting (PONV) in European countries. It is unclear how efficacious low-dose droperidol is in the prevention of PONV. To test the efficacy of low-dose droperidol in... more
Droperidol is widely used for the prevention of postoperative nausea and vomiting (PONV) in European countries. It is unclear how efficacious low-dose droperidol is in the prevention of PONV. To test the efficacy of low-dose droperidol in the prevention of PONV in adults and to test for dose-responsiveness. Systematic review of randomised controlled trials with meta-analyses. Comprehensive search in electronic databases (Medline, Embase, Central) up to June 2011. Additional trials were obtained from bibliographies of retrieved reports. No language restriction was applied. Randomised trials testing prophylactic intravenous droperidol ≤1 mg or ≤15 μg kg compared with placebo (or no treatment) in adults undergoing general anaesthesia and reporting on PONV. We analysed 25 trials (2957 patients). Doses varied from 0.25 to 1.0 mg. For prevention of early nausea (within 6 h postoperatively), relative risk (RR) was 0.45 (95% CI, 0.35 to 0.58); number needed to treat (NNT) was 7, 4, and 2 for low, medium and high baseline risk (i.e. control event rate 25, 50, 75%). For prevention of early vomiting, RR was 0.65 (95% CI, 0.57 to 0.74), NNT 11, 6, and 4. For prevention of late nausea (within 24 h), RR was 0.74 (95% CI, 0.62 to 0.87), NNT 15, 8, and 5. For prevention of late vomiting, RR was 0.61 (95% CI, 0.47 to 0.80), NNT 10, 5, and 3. Droperidol decreased the risk of headache but increased the risk of restlessness. For these outcomes there was no evidence of dose-responsiveness. There were no differences in the incidences of sedation or dizziness. Two patients receiving droperidol 0.625 mg had extrapyramidal symptoms. Cardiac toxicity data were not reported. Prophylactic doses of droperidol of 1 mg or below are antiemetic. Because adverse drug reactions are likely to be dose-dependent, there is an argument to stop using doses of more than 1 mg.