Study design and characteristics of the Luxembourg European Health Examination Survey (EHES-LUX).

BACKGROUND: The European Health Examination Survey in Luxembourg (EHES-LUX) is a population based survey performed from 2013 to 2015 with the aim to establish baseline information on the general health status of the Luxembourg population aged 25 to 64 years. The paper introduces the study design, recruitment method and representativeness of the sample, and summarizes the sociodemographic characteristics of participants and the prevalence of major health outcomes. METHODS: EHES-LUX is based on a random sample representative of the population of Luxembourg based on gender, age and district of residence. The sample size of the study was determined to provide accurate prevalence estimates for major chronic conditions. During two visits, data were collected from participants through a questionnaire (personal data, health status and health care), medical examinations (anthropometric measures, electrocardiogram and spirometry) and biological analysis (blood, urine and hair). Means and frequencies were used to describe the general characteristics of the population and a one-way ANOVA to test the representativeness of the sample and the comparability of participants and non-participants. RESULTS: A total of 1529 individuals participated in this study (participation rate of 24.1%). Differences between participants and non-participants based on gender, age and district of residence were corrected by sampling weights. The mean age (±SD) of participants was 44.9 (±10.1) years, of which 52.8% were women. Based on clinical measurements, nearly 20% of participants were obese and more than one in three participants were overweight. From measurements (respectively from self-report), 22.0% (respectively 12.2%) were hypertensive, 49.3% (respectively 22.5%) had hypercholesterolemia, 3.5% (respectively 3.7%) had diabetes and 7.6% (respectively 6.0%) had depressive symptoms. CONCLUSIONS: This nationwide epidemiological study on the general health status of Luxembourg residents provides updated prevalence estimates on a range of major health conditions. This information can be used by health authorities to evaluate policies and public health initiatives. At European level, prevalence data obtained by this study following the EHES-Reference Committee (EHES-RC) recommendations, will be comparable between European countries participating in this program.

A collaborative backbone resource for comparative studies of subterranean evolution: The World Asellidae database.

Transition to novel environments, such as groundwater colonization by surface organisms, provides an excellent research ground to study phenotypic evolution. However, interspecific comparative studies on evolution to groundwater life are few because of the challenge in assembling large ecological and molecular resources for species-rich taxa comprised of surface and subterranean species. Here, we make available to the scientific community an operational set of working tools and resources for the Asellidae, a family of freshwater isopods containing hundreds of surface and subterranean species. First, we release the World Asellidae database (WAD) and its web application, a sustainable and FAIR solution to producing and sharing data and biological material. WAD provides access to thousands of species occurrences, specimens, DNA extracts and DNA sequences with rich metadata ensuring full scientific traceability. Second, we perform a large-scale dated phylogenetic reconstruction of Asellidae to support phylogenetic comparative analyses. Of 424 terminal branches, we identify 34 pairs of surface and subterranean species representing independent replicates of the transition from surface water to groundwater. Third, we exemplify the usefulness of WAD for documenting phenotypic shifts associated with colonization of subterranean habitats. We provide the first phylogenetically controlled evidence that body size of males decreases relative to that of females upon groundwater colonization, suggesting competition for rare receptive females selects for smaller, more agile males in groundwater. By making these tools and resources widely accessible, we open up new opportunities for exploring how phenotypic traits evolve in response to changes in selective pressures and trade-offs during groundwater colonization.

Acute kidney injury according to pediatric RIFLE criteria is associated with negative outcomes after heart surgery in children.

BACKGROUND: The aim of this study was to investigate the association between the occurrence of acute kidney injury (AKI) according to pediatric RIFLE (pRIFLE) criteria and adverse outcomes in children after heart surgery. METHODS: Children undergoing heart surgery in a tertiary hospital in Southern Brazil were followed during their stay in the pediatric intensive care unit (PICU) or until death. The exposure variable was occurrence of AKI according to pRIFLE criteria which place AKI in three categories: R (risk), I (injury), and F (failure). The outcomes studied were death, length of mechanical ventilation (MV), and length of PICU stay. RESULTS: Eighty-five children were enrolled in the study. Of these, 47 (55.3 %) did not have AKI, while 22 (25.9 %), seven (8.2 %), and nine (10.6 %) were classified into pRIFLE categories R, I, and F, respectively. The incidence of death was 18.4 and 4.2 % in patients with and without AKI, respectively. Compared to children who did not develop AKI, the adjusted odds ratio for death was 1.05 [95 % confidence interval (CI) 0.09-11.11], 8.36 (95 % CI 1.32-52.63), and 7.85 (95 % CI 1.53-40.29) in the R, I, and F groups, respectively (p = 0.022). Duration of MV and of PICU stay were significantly higher in those children with AKI. CONCLUSIONS: The occurrence of AKI according to pRIFLE criteria is associated to adverse outcomes in children after heart surgery.

Antioxidant and Antiaging Properties of a Novel Synergistic Nutraceutical Complex: Readouts from an In Cellulo Study and an In Vivo Prospective, Randomized Trial.

Aging is a dynamic procedure that is developed in multiple layers and characterized by distinct hallmarks. The use of biomarkers that target different hallmarks of aging is substantial in predicting adverse outcomes during the aging process, implementing specifically designed antiaging interventions and monitoring responses to these interventions. The present study aimed to develop a novel composition of plant extracts, comprising identified active ingredients that synergistically target different hallmarks of aging in cellulo and in vivo. The selected single extracts and the developed composition were tested through a powerful set of biomarkers that we have previously identified and studied. The composition of selected extracts simultaneously increased cellular lifespan, reduced the cellular oxidative load and enhanced antioxidant defense mechanisms by increasing proteasome activity and content. In addition, the combination prevented telomere attrition and preserved optimum DNA methylation levels. Remarkably, biomarker profiling of healthy volunteers who received the identified combination in the form of a nutritional supplement within the frame of a prospective, randomized, controlled 3-month trial revealed an unprecedented antioxidant capacity in humans. In conclusion, our results support the notion that interventions with specifically designed combinations of natural compounds targeting multiple hallmarks of aging represent an effective way to improve healthspan and well-being.

Study rationale and design of OPTIMISE, a randomised controlled trial on the effect of benchmarking on quality of care in type 2 diabetes mellitus.

BACKGROUND: To investigate the effect of physician- and patient-specific feedback with benchmarking on the quality of care in adults with type 2 diabetes mellitus (T2DM). METHODS: Study centres in six European countries were randomised to either a benchmarking or control group. Physicians in both groups received feedback on modifiable outcome indicators (glycated haemoglobin [HbA1c], glycaemia, total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein [LDL]-cholesterol and triglycerides) for each patient at 0, 4, 8 and 12 months, based on the four times yearly control visits recommended by international guidelines. The benchmarking group also received comparative results on three critical quality indicators of vascular risk (HbA1c, LDL-cholesterol and systolic blood pressure [SBP]), checked against the results of their colleagues from the same country, and versus pre-set targets. After 12 months of follow up, the percentage of patients achieving the pre-determined targets for the three critical quality indicators will be assessed in the two groups. RESULTS: Recruitment was completed in December 2008 with 3994 evaluable patients. CONCLUSIONS: This paper discusses the study rationale and design of OPTIMISE, a randomised controlled study, that will help assess whether benchmarking is a useful clinical tool for improving outcomes in T2DM in primary care. TRIAL REGISTRATION: NCT00681850.

Nurses' participation in the end-of-life process in two paediatric intensive care units in Brazil.

The aim of this study was to evaluate the medical and nursing care provided to children in the last 24 hours of life in two Brazilian paediatric intensive care units and analyse the nurses' participation in the decision-making process for life support limitation (LSL). The study was based on an analysis of the patients' medical charts, looking at the medical and nursing care provided in the last 24 hours of life during a 6-month period in the two units, and on semi-structured interviews with 20 nurses to evaluate their participation in LSL decisions. The children were classified into two groups: those who were to receive full cardiopulmonary resuscitation (CPR) and a non-CPR group. A total of 34 deaths occurred during the study period. Of these, 17 (50%) were children that had been in the non-CPR group; there were only 10 recorded LSL plans in their medical charts. In the interviews, only 30% of the nurses mentioned active participation in LSL decisions. In conclusion, the paediatric intensive care nurses in these two Brazilian units did not participate much in LSL decisions, and the care offered in the last hours of life to children with terminal and irreversible illness was not primarily directed toward comfort and alleviating suffering.

Public health burden of pre-diabetes and diabetes in Luxembourg: finding from the 2013-2015 European Health Examination Survey.

OBJECTIVE: The aim of this study was to determine the burden and risk factors of prediabetes and diabetes in the general adult population of Luxembourg. DESIGN: Cross-sectional survey between 2013 and 2015. SETTING: Data were collected as part of the European Health Examination Survey in Luxembourg (EHES-LUX). PARTICIPANTS: 1451 individuals were recruited in a random sample of the 25-64-year-old population of Luxembourg. OUTCOMES: Diabetes was defined by a glycaemic biomarker (fasting plasma glucose (FPG) ≥7.0 mmol/L), self-reported medication and medical diagnosis; prediabetes by a glycaemic biomarker (FPG 5.6-6.9 mmol/L), no self-reported medication and no medical diagnosis. Undiagnosed diabetes was defined only from the glycaemic biomarker; the difference between total and undiagnosed diabetes was defined as diagnosed diabetes. Odds of diabetes and prediabetes as well as associated risk factors were estimated. RESULTS: The weighted prevalence of prediabetes and diabetes was 25.6% and 6.5%, respectively. Nearly 4.8% (men: 5.8%; women: 3.8%) were diagnosed diabetes and 1.7% (men: 2.6%; women: 0.7%) were undiagnosed diabetes. The multivariable-adjusted OR (MVOR) for diabetes risk were: age 1.05 (95% CI 1.01 to 1.09), family history of diabetes 3.24 (1.95-5.38), abdominal obesity 2.63 (1.53-4.52), hypertension 3.18 (1.76-5.72), one-unit increase of triglycerides 1.16 (1.10-1.22) and total cholesterol 0.74 (0.64-0.86). The MVOR for prediabetes risk were: age 1.04 (95% CI 1.02 to 1.06), male sex 1.84 (1.30-2.60), moderate alcohol consumption 1.38 (1.01-1.89), family history of diabetes 1.52 (1.13-2.05), abdominal obesity 1.44 (1.06-1.97), second-generation immigrants 0.61 (0.39-0.95) and a one-unit increase of serum high-density lipoprotein cholesterol 0.70 (0.54-0.90). CONCLUSIONS: In Luxembourg, an unexpectedly high number of adults may be affected by prediabetes and diabetes. Therefore, these conditions should be addressed as a public health priority for the country, requiring measures for enhanced detection and surveillance, which are currently lacking, especially in primary care settings.

Discovery Belux: comparison of rosuvastatin with atorvastatin in hypercholesterolaemia.

METHODS: Discovery Belux is an open-label, multicentre, randomised, phase IIIb, parallel group study comparing the efficacy of rosuvastatin (RSV) and atorvastatin (ATV) on changes in lipid levels and the achievement of European Atherosclerosis Society (EAS) lipid goals. Patients (> or = 18 years) with primary hypercholesterolaemia, with a low-density lipoprotein (LDL-C) level > 120 mg/dl (on treatment) or > 135 mg/dl (naive subjects), and with a statin indication, were randomised to receive RSV 10 mg/day or ATV 10 mg/day for 12 weeks. Patients not at goal after 12 weeks and receiving ATV 10 were further switched to RSV 10 mg for another 12 weeks. Patients not at goal with RSV 10 mg were further titrated to RSV 20 mg. RESULTS: 938 patients were randomised to the two treatment groups. After 12 weeks of treatment, a significantly greater percentage of patients receiving RSV 10 compared with ATV 10 achieved EAS LDL-C target goal (< 115 mg/dl) (85% vs. 67%). LDL-C was reduced by 47% and total cholesterol (TC) by 33% with RSV 10.This was 38% and 27% for ATV 10, respectively. After 24 weeks, an additional 57% of patients initially taking RSV 10 and uncontrolled, reached the target with RSV 20. In the patient group, initially taking ATV 10 and uncontrolled, 65% reached the target with RSV 10 after 24 weeks. Both treatments were well tolerated with a similar incidence of adverse events. In addition, a health economic analysis was performed. As RSV 10 is available at a lower cost in Belgium and as it is more effective, compared to ATV 10, it appeared to be the option of choice from a cost-effectiveness perspective. CONCLUSIONS: Rosuvastatin 10 mg treatment is significantly more effective than atorvastatin 10 mg at achieving European LDL-C goals, at lowering LDL-C and TC. These results were obtained with a similar safety profile. From a cost-effectiveness perspective RSV 10 is the preferred therapeutic option in comparison with ATV 10. Uptitration of uncontrolled patients to RSV 20 mg and switch from ATV 10 to RSV 10 allowed significantly more patients to reach the LDL-C and TC target goal.

Anti-ageing properties of Khelma Longevity™: treatment of human fibroblasts increases proteasome levels and decreases the levels of oxidized proteins.

We have determined the putative anti-ageing properties of Khelma Longevity™, a formula based on various natural compounds from the Mediterranean area. Human primary fibroblast cultures were treated with a wide range of concentrations of Khelma Longevity™ for 1 day or 3 consecutive days. Following these treatments, two major and complementary biomarkers of ageing were measured, namely, the proteasome and the amount of oxidized proteins. It was observed that 24h of treatment with Khelma Longevity™ resulted in a maximum increase of about 41% of the total protein levels of 20S proteasome. Levels of oxidized proteins were reduced by almost 6.5-fold following longer treatments. Specifically we have observed a maximum decrease of protein carbonyls to 84.7% in comparison with nontreated control cells following 3 days of continuous treatment with Khelma Longevity™. These results support the notion that formulas rich in natural compounds from the Mediterranean area possess anti-ageing properties.

Risk factors for coronary heart disease in type 1 diabetic patients in Europe: the EURODIAB Prospective Complications Study.

OBJECTIVE: The goal of the study was to examine risk factors in the prediction of coronary heart disease (CHD) and differences in men and women in the EURODIAB Prospective Complications Study. RESEARCH DESIGN AND METHODS: Baseline risk factors and CHD at follow-up were assessed in 2,329 type 1 diabetic patients without prior CHD. CHD was defined as physician-diagnosed myocardial infarction, angina pectoris, coronary artery bypass graft surgery, and/or Minnesota-coded ischemic electrocardiograms or fatal CHD. RESULTS: There were 151 patients who developed CHD, and the 7-year incidence rate was 8.0 (per 1,000 person-years) in men and 10.2 in women. After adjustment for age and/or duration of diabetes, the following risk factors were related to CHD in men: age, GHb, waist-to-hip ratio (WHR), HDL cholesterol, smoking, albumin excretion rate (AER), and autonomic neuropathy. The following risk factors were related to CHD in women: age, systolic blood pressure (BP), fasting triglycerides, AER, and retinopathy. Multivariate standardized Cox proportional hazards models showed that age (hazard ratio 1.5), AER (1.3 in men and 1.6 in women), WHR (1.3 in men), smoking (1.5 in men), fasting triglycerides (1.3 in women) or HDL cholesterol (0.74 in women), and systolic BP (1.3 in women) were predictors of CHD. CONCLUSIONS: This study supports the evidence for a strong predictive role of baseline albuminuria in the pathogenesis of CHD in type 1 diabetes. Furthermore, sex-specific risk factors such as systolic BP, fasting triglycerides (or HDL cholesterol), and WHR were found to be important in the development of CHD.

Toward improved guideline quality: using the COGS statement with GEM.

The Conference on Guideline Standardization (COGS) was convened to create a standardized documentation checklist for clinical practice guidelines in an effort to promote guideline quality and facilitate implementation. The statement was created by a multidisciplinary panel using a rigorous consensus development methodology. The Guideline Elements Model (GEM) provides a standardized approach to representing guideline documents using XML. In this work, we demonstrate the sufficiency of GEM for describing COGS components. Using the mapping between COGS and GEM elements we built an XSLT application to examine a guideline's adherence (or non-adherence) to the COGS checklist. Once a guideline has been marked up according to the GEM hierarchy, its knowledge content can be reused in multiple ways.

Optimal type 2 diabetes mellitus management: the randomised controlled OPTIMISE benchmarking study: baseline results from six European countries.

BACKGROUND: Micro- and macrovascular complications of type 2 diabetes have an adverse impact on survival, quality of life and healthcare costs. The OPTIMISE (OPtimal Type 2 dIabetes Management Including benchmarking and Standard trEatment) trial comparing physicians' individual performances with a peer group evaluates the hypothesis that benchmarking, using assessments of change in three critical quality indicators of vascular risk: glycated haemoglobin (HbA1c), low-density lipoprotein-cholesterol (LDL-C) and systolic blood pressure (SBP), may improve quality of care in type 2 diabetes in the primary care setting. DESIGN: This was a randomised, controlled study of 3980 patients with type 2 diabetes. METHODS: Six European countries participated in the OPTIMISE study (NCT00681850). Quality of care was assessed by the percentage of patients achieving pre-set targets for the three critical quality indicators over 12 months. Physicians were randomly assigned to receive either benchmarked or non-benchmarked feedback. All physicians received feedback on six of their patients' modifiable outcome indicators (HbA1c, fasting glycaemia, total cholesterol, high-density lipoprotein-cholesterol (HDL-C), LDL-C and triglycerides). Physicians in the benchmarking group additionally received information on levels of control achieved for the three critical quality indicators compared with colleagues. RESULTS: At baseline, the percentage of evaluable patients (N = 3980) achieving pre-set targets was 51.2% (HbA1c; n = 2028/3964); 34.9% (LDL-C; n = 1350/3865); 27.3% (systolic blood pressure; n = 911/3337). CONCLUSIONS: OPTIMISE confirms that target achievement in the primary care setting is suboptimal for all three critical quality indicators. This represents an unmet but modifiable need to revisit the mechanisms and management of improving care in type 2 diabetes. OPTIMISE will help to assess whether benchmarking is a useful clinical tool for improving outcomes in type 2 diabetes.

Benchmarking is associated with improved quality of care in type 2 diabetes: the OPTIMISE randomized, controlled trial.

OBJECTIVE: To assess prospectively the effect of benchmarking on quality of primary care for patients with type 2 diabetes by using three major modifiable cardiovascular risk factors as critical quality indicators. RESEARCH DESIGN AND METHODS: Primary care physicians treating patients with type 2 diabetes in six European countries were randomized to give standard care (control group) or standard care with feedback benchmarked against other centers in each country (benchmarking group). In both groups, laboratory tests were performed every 4 months. The primary end point was the percentage of patients achieving preset targets of the critical quality indicators HbA1c, LDL cholesterol, and systolic blood pressure (SBP) after 12 months of follow-up. RESULTS: Of 4,027 patients enrolled, 3,996 patients were evaluable and 3,487 completed 12 months of follow-up. Primary end point of HbA1c target was achieved in the benchmarking group by 58.9 vs. 62.1% in the control group (P = 0.398) after 12 months; 40.0 vs. 30.1% patients met the SBP target (P < 0.001); 54.3 vs. 49.7% met the LDL cholesterol target (P = 0.006). Percentages of patients meeting all three targets increased during the study in both groups, with a statistically significant increase observed in the benchmarking group. The percentage of patients achieving all three targets at month 12 was significantly larger in the benchmarking group than in the control group (12.5 vs. 8.1%; P < 0.001). CONCLUSIONS: In this prospective, randomized, controlled study, benchmarking was shown to be an effective tool for increasing achievement of critical quality indicators and potentially reducing patient cardiovascular residual risk profile.

A comparison of gradual sedation levels using the Comfort-B scale and bispectral index in children on mechanical ventilation in the pediatric intensive care unit.

OBJECTIVE: Compare the scores resulting from the Comfort-B scale with the bispectral index in children in an intensive care unit. METHODS: Eleven children between the ages of 1 month and 16 years requiring mechanical ventilation and sedation were simultaneously classified based on the bispectral index and the Comfort-B scale. Their behavior was recorded using digital photography, and the record was later evaluated by three independent evaluators. Agreement tests (Bland-Altman and Kappa) were then performed. The correlation between the two methods (Pearson correlation) was tested. RESULTS: In total, 35 observations were performed on 11 patients. Based on the Kappa coefficient, the agreement among evaluators ranged from 0.56 to 0.75 (p<0.001). There was a positive and consistent association between the bispectral index and the Comfort-B scale [r=0.424 (p=0.011) to r=0.498 (p=0.002)]. CONCLUSION: Due to the strong correlation between the independent evaluators and the consistent correlation between the two methods, the results suggest that the Comfort-B scale is reproducible and useful in classifying the level of sedation in children requiring mechanical ventilation.

Admission source and mortality in a pediatric intensive care unit.

BACKGROUND AND AIMS: Studies carried out in different countries have shown that source of patient admission in Intensive Care Units (ICUs) is associated to death. Patients admitted from wards show a greater ICU mortality. The aim of the present study was to investigate the association between admission source and outcome in a Pediatric Intensive Care Unit (PICU). MATERIALS AND METHODS: We studied all PICU admissions that took place between January 2002 and December 2005 in a tertiary hospital in Brazil. The major outcome studied was death while in the PICU. The independent variable analyzed was admission source, defined either as pediatric emergency room (PER), wards, operating room (OR) of the same hospital or other sources. RESULTS: A total of 1823 admissions were studied. The overall expected mortality based on the Pediatric Index of Mortality 2 was 6.5% and the observed mortality was 10.3%. In adjusted analysis, the mortality was doubled in patients admitted from wards when compared with the PER patients. CONCLUSIONS: Observed mortality rates were higher in patients admitted from wards within the same hospital, even after adjustment.

Centralized Pan-European survey on the under-treatment of hypercholesterolaemia (CEPHEUS): overall findings from eight countries.

BACKGROUND: Surveys evaluating plasma lipid goal attainment in patients with coronary heart disease have shown that hypercholesterolaemia is inadequately treated. Limited data account for the reasons behind this. The aim of the CEntralized Pan-European survey on tHE Under-treatment of hypercholeSterolaemia (CEPHEUS) survey was to evaluate the current use and efficacy of lipid-lowering drugs (LLD), and to identify possible patient/physician characteristics associated with failure to achieve low-density lipoprotein cholesterol (LDL-C) targets recommended by the 2003 European guidelines (Third Joint Task Force). METHODS: CEPHEUS was a European, multi-centre, cross-sectional survey conducted in eight countries and involved patients on LLD for >3 months (stable medication >6 weeks). One visit was scheduled for data collection, including fasting lipids. In all but one country, physicians and patients filled in a questionnaire about aspects of hypercholesterolaemia and treatment. RESULTS: Of the 15 199 patients recruited, 14 478 were included in the final analyses. The mean age was 63.2 years, and 45% of patients were female. Overall, 55.3% of the patients achieved their LDL-C target. In multivariate analyses, the factors identified as positive predictors for achieving LDL-C goals included normal body mass index, not smoking, not having metabolic syndrome, being on statin therapy and good treatment adherence. LIMITATIONS: The population was a selected group of subjects treated with LLD, and the results cannot be extrapolated to the general population. Patient consent was obtained, which may have selected more motivated patients and induced a positive bias. The physician and patient questionnaires were not validated, but were only used for exploratory purposes. CONCLUSION: Only 55.3% of patients using LLD achieved the LDL-C target recommended in the 2003 European guidelines.

Comparacao dos niveis de sedacao graduados pela escala Comfort-B e pelo indice biespectral de criancas em ventilacao mecanica na unidade de terapia intensiva pediatrica / A comparison of gradual sedation levels using the Comfort-B scale and bispectral index in children on mechanical ventilation in the pediatric intensive care unit

Objetivo: Comparar os escores resultantes da escala Comfort-B com o índice biespectral, em crianças de uma unidade de terapia intensiva. Métodos: Onze crianças com idades entre 1 mês e 16 anos, submetidas a ventilação mecânica e sedação, foram classificadas pelo índice biespectral e pela escala Comfort-B, simultaneamente. Foi obtido registro de seus comportamentos por filmagem digital; posteriormente tal registro foi avaliado por três observadores independentes e foram aplicados testes de concordância (Bland-Altman e Kappa). Foi testada a correlação entre os dois métodos (correlação de Pearson). Resultados: Foram realizadas 35 observações em 11 pacientes. A concordância entre os avaliadores, segundo o coeficiente de Kappa, variou de 0,56 a 0,75 (p<0,001). Houve associação positiva e regular entre índice biespectral e Comfort-B, com r=0,424 (p=0,011) até r=0,498 (p=0,002). Conclusão: Devido à alta concordância entre os avaliadores independentes e a correlação regular entre os dois métodos, conclui-se que a escala Comfort-B é reprodutível e útil na classificação do nível de sedação de crianças em ventilação mecânica. .

Objective: Compare the scores resulting from the Comfort-B scale with the bispectral index in children in an intensive care unit. Methods: Eleven children between the ages of 1 month and 16 years requiring mechanical ventilation and sedation were simultaneously classified based on the bispectral index and the Comfort-B scale. Their behavior was recorded using digital photography, and the record was later evaluated by three independent evaluators. Agreement tests (Bland-Altman and Kappa) were then performed. The correlation between the two methods (Pearson correlation) was tested. Results: In total, 35 observations were performed on 11 patients. Based on the Kappa coefficient, the agreement among evaluators ranged from 0.56 to 0.75 (p<0.001). There was a positive and consistent association between the bispectral index and the Comfort-B scale [r=0.424 (p=0.011) to r=0.498 (p=0.002)]. Conclusion: Due to the strong correlation between the independent evaluators and the consistent correlation between the two methods, the results suggest that the Comfort-B scale is reproducible and useful in classifying the level of sedation in children requiring mechanical ventilation. .