Participer à un protocole de recherche clinique pédiatrique?

Introduction Dans le cadre d’une recherche clinique, le recueil du consentement représente une obligation légale au même titre que lorsqu’il s’agit d’informer la personne malade. La loi ne permet pas d’inclure un enfant dans une recherche sans le consentement signé des parents ou du représentant de l’autorité parentale. Le non-respect de cette obligation porte une atteinte grave aux droits de la personne malade. Pour le patient mineur son consentement « doit également être recherché lorsqu’i..

Participer à un protocole de recherche clinique pédiatrique?

Introduction Dans le cadre d’une recherche clinique, le recueil du consentement représente une obligation légale au même titre que lorsqu’il s’agit d’informer la personne malade. La loi ne permet pas d’inclure un enfant dans une recherche sans le consentement signé des parents ou du représentant de l’autorité parentale. Le non-respect de cette obligation porte une atteinte grave aux droits de la personne malade. Pour le patient mineur son consentement « doit également être recherché lorsqu’i..

Analysis of the impact of the SARS-CoV-2 infection on the pediatric population hospitalized during the pandemic in the Greater Paris University Hospitals

BackgroundThe clinical characteristics, disease progression and outcome in children affected by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection appear significantly milder compared to older individuals. Nevertheless, the trends in hospitalization and clinical characteristics in the pediatric population seem to be different over time across the different epidemic waves.ObjectiveOur aim was to understand the impact of the different COVID-19 variants in the pediatric population hospitalized in the Pediatric Departments of the Public Hospital in the Greater Paris area by the analysis performed with the Assistance Publique-Hopitaux de Paris (AP-HP) Health Data Warehouse.MethodsThis is a retrospective cohort study including 9,163 patients under 18 years of age, hospitalized from 1 March 2020 to 22 March 2022, in the Paris area, with confirmed infection by SARS-CoV-2. Three mutually exclusive groups with decreasing severity (Pediatric Inflammatory Multisystem Syndrome (PIMS), symptomatic infection, mild or asymptomatic infection) were defined and described regarding demography, medical history, complication of the SARS-CoV-2 infection, and treatment during admission. Temporal evolution was described by defining three successive waves (March–September 2020, October 2020–October 2021, and November 2021–March 2022) corresponding to the emergence of the successive variants.ResultsIn the study period, 9,163 pediatric patients with SARS-CoV-2 infection were hospitalized in 21 AP-HP hospitals. The number of patients with SARS-CoV-2 infection increased over time for each wave of the pandemic (the mean number of patients per month during the first wave was 332, 322 during the 2nd, and 595 during the third wave). In the medical history, the most associated concomitant disease was chronic respiratory disease. Patients hospitalized during the third wave presented a higher incidence of pulmonary involvement (10.2% compared to 7% and 6.5% during the first and second waves, respectively). The highest incidence of PIMS was observed during the first and second waves (4.2% in the first and second waves compared to 2.3% in the 3rd wave).DiscussionThis analysis highlighted the high incidence of hospitalized children in the Greater Paris Area during the third wave of SARS-CoV-2 pandemic corresponding to the Omicron Covid-19 variant, which is probably an expression of a concomitant SARS-CoV-2, while a decreased incidence of PIMS complication was observed during the same period

Readability of the Written Study Information in Pediatric Research in France

BACKGROUND: The aim was to evaluate the readability of research information leaflets (RIL) for minors asked to participate in biomedical research studies and to assess the factors influencing this readability. METHODS AND FINDINGS: All the pediatric protocols from three French pediatric clinical research units were included (N = 104). Three criteria were used to evaluate readability: length of the text, Flesch's readability score and presence of illustrations. We compared the readability of RIL to texts specifically written for children (school textbooks, school exams or extracts from literary works). We assessed the effect of protocol characteristics on readability. The RIL had a median length of 608 words [350 words, 25(th) percentile; 1005 words, 75(th) percentile], corresponding to two pages. The readability of the RIL, with a median Flesch score of 40 [30; 47], was much poorer than that of pediatric reference texts, with a Flesch score of 67 [60; 73]. A small proportion of RIL (13/91; 14%) were illustrated. The RIL were longer (p<0.001), more readable (p<0.001) and more likely to be illustrated (p<0.009) for industrial than for institutional sponsors. CONCLUSION: Researchers should routinely compute the reading ease of study information sheets and make greater efforts to improve the readability of written documents for potential participants

The Readability of Information and Consent Forms in Clinical Research in France

BACKGROUND: Quantitative tools have been developed to evaluate the readability of written documents and have been used in several studies to evaluate information and consent forms. These studies all showed that such documents had a low level of readability. Our objective is to evaluate the readability of Information and Consent Forms (ICFs) used in clinical research. METHODS AND FINDINGS: Clinical research protocols were collected from four public clinical research centers in France. Readability was evaluated based on three criteria: the presence of an illustration, the length of the text and its Flesch score. Potential effects of protocol characteristics on the length and readability of the ICFs were determined. Medical and statutory parts of the ICF form were analyzed separately. The readability of these documents was compared with that of everyday contracts, press articles, literary extracts and political speeches. We included 209 protocols and the corresponding 275 ICFs. The median length was 1304 words. Their Flesch readability scores were low (median: 24), and only about half that of selected press articles. ICF s for industrially sponsored and randomized protocols were the longest and had the highest readability scores. More than half (52%) of the text in ICFs concerned medical information, and this information was statistically (p<0.05) more readable (Flesch: 28) than statutory information (Flesch: 21). CONCLUSION: Regardless of the field of research, the ICFs for protocols included had poor readability scores. However, a prospective analysis of this test in French should be carried out before it is put into general use

Etude du passage transplacentaire des antirétroviraux chez des patientes infectées par le VIH

Objectif : On observe une augmentation du nombre de molécules antirétrovirales qui sont maintenant prescrites chez les femmes enceintes infectées par le VIH, soit pour la prévention de la transmission materno-fœtale du virus, soit pour le traitement de la mère. Cependant, peu d'informations sont disponibles concernant cette utilisation de molécules antirétrovirales pendant la grossesse. Notre objectif était d'étudier le passage transplacentaire et les concentrations amniotiques des antirétroviraux lorsqu'ils étaient donnés à des femmes enceintes infectées par le VIH. Méthode : Les mères recevaient un traitement antirétroviral dans le cadre de leur prise en charge clinique. Les échantillons de sang maternel, fœtal et de liquide amniotique ont été obtenus au moment de l'accouchement chez 103 patients. Résultats : Les associations les plus fréquentes d'antirétroviraux utilisés dans notre population étaient zidovudine, lamivudine, nelfinavir (n=20), zidovudine, lamivudine, nevirapine (n=13), zidovudine, lamivudine (n=8), didanosine, stavudine, nelfinavir (n=7). Il existait une corrélation significative entre les concentrations plasmatiques maternelles et fœtales pour la zidovudine, la lamivudine, la stavudine, le didanosine, le nelfinavir et la névirapine. Les rapports entre les concentrations fœtale et maternelle étaient élevés pour la zidovudine (R=1,22), la stavudine (R=1,32), la lamivudine (R=0,93) et la névirapine (R=0,88), faibles pour le didanosine (R=0,38), le nelfinavir (R=0,24) et l'amprénavir (R=0,27) et nuls pour le ritonavir, l'indinavir et le saquinavir. Pour les molécules à excrétion rénale (G-AZT, 3TC, M8), des concentrations élevées dans le liquide amniotique ont été trouvées. Conclusion : Ce travail montre qu'il existe une grande variabilité du passage transplacentaire des antirétroviraux selon le type de molécule. Ces résultats ont des implications cliniques pour la surveillance des effets indésirables de ces molécules ches les enfants qui ont été exposés in utero.PARIS7-Xavier Bichat (751182101) / SudocPARIS-BIUM (751062103) / SudocSudocFranceF

Analgésie-sédation aux urgences : du nouveau-né à l’adolescent

International audienc

Analgésie-sédation aux urgences : du nouveau-né à l’adolescent

International audienc

Analgésie-sédation aux urgences : du nouveau-né à l’adolescent

International audienc