Ethical considerations of the dynamics of clinical trials in an epidemic context: Studies on COVID-19

International audienceThe COVID-19 epidemic has led to the intense mobilization of all health professionals, including those involved in research. From the very beginning, research ethics committees (RECs) have been called upon and mobilized to carry out the scientific and ethical evaluations of research projects to achieve a sound analysis of their risk/benefit balance. The aim of this article is to present an ethical reflection on the challenges and consequences of the fast-track procedure for the evaluation of COVID-19 research projects in the context of a public health emergency. Indeed, a large number of protocols of reduced rigor were hastily prepared without collaboration between researchers and in the absence of national regulation. As a result, a number of ethical dilemmas have emerged concerning the opposing needs of pragmatism imposed by the emergency context and the ethical principles that should govern the conduct of research. Moreover, the dispersion of these individual projects, aggravated by excessive media coverage of specific treatments, has resulted in a weakened impact of the research in the epidemic context. This article provides suggestions for the ethical management of ongoing and upcoming research, giving RECs the opportunity to adapt their evaluations to avoid allowing the pragmatism of the emergency context to subvert the inviolability of the epistemological and ethical principles of research on humans. This reflection may strengthen the ethical basis for the formulation of their decisions

Psychometric properties of a self-assessment fear scale in children aged 4 to 12 years. Scary Scale

International audienceBackgroundCaregivers encounter difficulties differentiating fear and pain experienced by children and tend to interpret what children may feel, often resulting in inadequate pain management. While many pain self-assessment scales are available, there is no validated self-assessment fear scale for children.Methods: The aim of this prospective study was to validate, in children aged 4 to 12 years, the psychometric properties of our scale. In a first part, in a school setting, five exercises were given to 484 children in order to validate the expression of fear, grade the intensity of the faces, the ability to discriminate the faces and the equality of the intervals. The scale's reproducibility was studied by assessing the children's fear in everyday situations at two different time points.In a second part, in a hospital setting, the aim was to test the scale's feasibility. Sixty children admitted to one emergency care department self-assessed their fear with the Scary Scale.FindingsThe expression of fear was validated by 57.64% (p < 0.0001) of the children in comparison with three other emotions (pain, surprise, sadness).The 7–9 year-olds validated the other properties (gradation, discrimination, equality, reproducibility). The 4–6 year-olds failed to validate the gradation exercise, but succeeded with the others.In the hospital, 95% of children self-assessed their fear using the scale.DiscussionOur self-assessment fear scale was validated in children aged 7–12 years specifically and was readily feasible in the hospital. We recommend its use in that age group in every care situation triggering fear.Trial registration: clinicaltrials.gov Identifier: NCT02675504

[Parapneumonic pleural effusion incidence in a French region before and during the antipneumococcal vaccine era].

International audienceBACKGROUND AND AIMS: The aim of the study was to compare the incidence of parapneumonic pleural effusion in the Limousin region of France, based on the comparison of pre- and postvaccination periods. METHODS: Subjects, 0-18-years-old, were retrospectively identified by searching in computerized databases of coded discharge diagnosis for patients with a diagnosis of pleural effusion and/or empyema and/or pulmonary infection in all the pediatric departments in Limousin hospitals. Medical records were reviewed by one of the authors and those with parapneumonic effusion and confirmed or suspected pneumococcal infection were included in the study. Data from the children hospitalized for parapneumonic pleural effusion were collected for two periods: period A, from July 2000 to July 2006, and period B, from July 2006 to July 2009 (before and after the generalization of the antipneumococcal vaccination). The main endpoint was the number of parapneumonic pleural effusion cases in each period in order to calculate the incidence within each period. RESULTS: A total of 35 children were included: nine during period A and 26 during period B. The incidence was 1 per 100,000 children for period A and 5.8 per 100,000 for period B. Bacteriological tests allowed us to serotype eight S. pneumoniae over the two periods. All serotypes were non-vaccine serotypes (1, 3, and 19A). CONCLUSION: This study demonstrates the increase in parapneumonic pleural effusion in the Limousin region

Les contes de Canterbury de Geoffroy Chaucer. Tr. française avec une introd. et des notes par Th. Bahans, J. Banchet, Ch. Bastide, P. Berger, L. Bourgogne, M. Castelain, L. Cazamian, Ch. Cestre, Ch. Clermont, J. Delcourt, J. Derocquigny, C.-M. Garnier, R. Huchon, A. Koszul, L. Lavault, E. Legouis, L. Morel, Ch. Petit, W. Thomas, G. Vallod, E. Wahl.

Mode of access: Internet

Antibiotic prophylaxis in preterm premature rupture of membranes at 24–31 weeks’ gestation: Perinatal and 2‐year outcomes in the EPIPAGE‐2 cohort

International audienceObjectiveTo compare different antibiotic prophylaxis administered after preterm premature rupture of membranes to determine whether any were associated with differences in obstetric and/or neonatal outcomes and/or neurodevelopmental outcomes at 2 years of corrected age.DesignProspective, nationwide, population-based EPIPAGE-2 cohort study of preterm infants.SettingFrance, 2011.SampleWe included 492 women with a singleton pregnancy and a diagnosis of preterm premature rupture of membranes at 24–31 weeks. Exclusion criteria were contraindication to expectant management or indication for antibiotic therapy other than preterm premature rupture of membranes. Antibiotic prophylaxis was categorised as amoxicillin (n = 345), macrolide (n = 30), third-generation cephalosporin (n = 45) or any combinations covering Streptococcus agalactiae and >90% of Escherichia coli (n = 72), initiated within 24 hours after preterm premature rupture of membranes.MethodsPopulation-averaged robust Poisson models.Main Outcome MeasuresSurvival at discharge without severe neonatal morbidity, 2-year neurodevelopment.ResultsWith amoxicillin, macrolide, third-generation cephalosporin and combinations, 78.5%, 83.9%, 93.6% and 86.0% of neonates were discharged alive without severe morbidity. The administration of third-generation cephalosporin or any E. coli-targeting combinations was associated with improved survival without severe morbidity (adjusted risk ratio 1.25 [95% confidence interval 1.08–1.45] and 1.10 [95 % confidence interval 1.01–1.20], respectively) compared with amoxicillin. We evidenced no increase in neonatal sepsis related to third-generation cephalosporin-resistant pathogen.ConclusionIn preterm premature rupture of membranes at 24–31 weeks, antibiotic prophylaxis based on third-generation cephalosporin may be associated with improved survival without severe neonatal morbidity when compared with amoxicillin, with no evidence of increase in neonatal sepsis related to third-generation cephalosporin-resistant pathogen