{"title":"The value of registries for rare and severe adverse events in paediatrics","authors":"Robin J Prescott","doi":"10.1016/S2352-4642(24)00106-8","DOIUrl":"10.1016/S2352-4642(24)00106-8","url":null,"abstract":"","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"8 6","pages":"Pages 389-390"},"PeriodicalIF":36.4,"publicationDate":"2024-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140867988","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Renz C W Klomberg MD , Astrid E Hellendoorn MD , Polychronis Kemos MSc , Dimitris Rizopoulos PhD , Prof Frank M Ruemmele PhD , Prof Nicholas M Croft PhD , Lissy de Ridder PhD
{"title":"Rare and severe adverse events in children with inflammatory bowel disease: analysis of data from the PIBD-SETQuality Safety Registry","authors":"Renz C W Klomberg MD , Astrid E Hellendoorn MD , Polychronis Kemos MSc , Dimitris Rizopoulos PhD , Prof Frank M Ruemmele PhD , Prof Nicholas M Croft PhD , Lissy de Ridder PhD","doi":"10.1016/S2352-4642(24)00078-6","DOIUrl":"10.1016/S2352-4642(24)00078-6","url":null,"abstract":"<div><h3>Background</h3><p>Rare and severe adverse events can occur in children with inflammatory bowel disease (IBD), and the relationship with disease or drug treatment is often uncertain. We aimed to establish a method of reporting adverse events of interest in children with IBD, allowing for estimates of incidence rates with comparison between different regions, and, if possible, to compare with published data on rates of adverse events in children overall.</p></div><div><h3>Methods</h3><p>For this analysis, we used data from the Paediatric Inflammatory Bowel Disease Network for Safety, Efficacy and Treatment and Quality improvement of care (PIBD-SETQuality) Safety Registry, which collects data on multiple rare and severe adverse events in children younger than 19 years with IBD. Overall, the registry collected data on ten prespecified rare and severe adverse events in children with IBD, as established by a panel of paediatric IBD experts, via reports from paediatric gastroenterologists at participating hospitals between Nov 1, 2016, and March 31, 2023. Reporting physicians, who could only be paediatric gastroenterologists or IBD nurses reporting on behalf of paediatric gastroenterologists, were recruited through invitations sent to both national and international IBD networks and at conferences. Once per month, participating paediatric gastroenterologists received an email with an anonymous and unique link to an online survey asking them to report whether any of ten rare and severe adverse events had occurred in a patient in their paediatric-IBD population in the previous month. Prevalent or retrospective rare and severe adverse events were excluded, as were events occurring in children with an unconfirmed diagnosis of IBD or for whom inflammatory colitis was part of a monogenic immunodeficiency disorder. Duplicates and events that did not meet the definitions and criteria were excluded. Physicians could also report other, non-categorised adverse events if they considered them rare and severe. In case of no response, up to two reminders were sent for each per-month survey. Annual denominator data surveys were sent to obtain the total number of person-years for the estimation of incidence rates, which were calculated via Poisson regression models.</p></div><div><h3>Findings</h3><p>Responses were gathered from 220 paediatric gastroenterologists from 167 centres. 121 centres were in Europe, 23 centres were in North America, 17 centres were in Asia, and six centres were in Oceania. Combined, the total population with paediatric IBD consisted of an estimated 30 193 children with 114 528 person-years of follow-up. 451 adverse events were initially reported. After excluding and reorganising adverse events, 402 were eligible; 261 (65%) were categorised and 141 (35%) were non-categorised. The most frequently reported adverse events were venous-thromboembolic events (n=66), renal failure (n=43), opportunistic infections (n=42), and cancer (n=33). Haem","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"8 6","pages":"Pages 422-432"},"PeriodicalIF":36.4,"publicationDate":"2024-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140874243","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Correction to Lancet Child Adolesc Health 2024; published online April 16. https://doi.org/10.1016/S2352-4642(24)00075-0","authors":"","doi":"10.1016/S2352-4642(24)00107-X","DOIUrl":"10.1016/S2352-4642(24)00107-X","url":null,"abstract":"","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"8 6","pages":"Page e7"},"PeriodicalIF":36.4,"publicationDate":"2024-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S235246422400107X/pdfft?md5=9fe8a75a78f8a68b2738fb650739e268&pid=1-s2.0-S235246422400107X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140777195","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alasdair Bamford PhD , Tiziana Masini PhD , Phoebe Williams DPhil , Prof Mike Sharland MD , Valeria Gigante PhD , Devika Dixit MD , Hatim Sati MD , Benedikt Huttner MD , Yasir Bin Nisar PhD , Bernadette Cappello MPH , Wilson Were MD , Jennifer Cohn MD , Martina Penazzato PhD , PADO-antibiotics participants
{"title":"Tackling the threat of antimicrobial resistance in neonates and children: outcomes from the first WHO-convened Paediatric Drug Optimisation exercise for antibiotics","authors":"Alasdair Bamford PhD , Tiziana Masini PhD , Phoebe Williams DPhil , Prof Mike Sharland MD , Valeria Gigante PhD , Devika Dixit MD , Hatim Sati MD , Benedikt Huttner MD , Yasir Bin Nisar PhD , Bernadette Cappello MPH , Wilson Were MD , Jennifer Cohn MD , Martina Penazzato PhD , PADO-antibiotics participants","doi":"10.1016/S2352-4642(24)00048-8","DOIUrl":"10.1016/S2352-4642(24)00048-8","url":null,"abstract":"<div><p>Children and neonates are highly vulnerable to the impact of antimicrobial resistance. Substantial barriers are faced in relation to research and development of antibacterial agents for use in neonates, children, and adolescents aged yonger than 19 years, and focusing finite resources on the most appropriate agents for development and paediatric optimisation is urgently needed. In November and December, 2022, following the successes of previous similar disease-focused exercises, WHO convened the first Paediatric Drug Optimisation (PADO) exercise for antibiotics, aiming to provide a shortlist of antibiotics to be prioritised for paediatric research and development, especially for use in regions with the highest burden of disease attributable to serious bacterial infection. A range of antibiotics with either existing license for children or in clinical development in adults but with little paediatric data were considered, and PADO priority and PADO watch lists were formulated. This Review provides the background and overview of the exercise processes and its outcomes as well as a concise review of the literature supporting decision making. Follow-up actions to implement the outcomes from the PADO for antibiotics process are also summarised. This Review highlights the major beneficial influence the collaborative PADO process can have, both for therapeutic drug class and disease-specific themes, in uniting efforts to ensure children have access to essential medicines across the world.</p></div>","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"8 6","pages":"Pages 456-466"},"PeriodicalIF":36.4,"publicationDate":"2024-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140776178","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Thomas Steare MSc , Prof Glyn Lewis PhD , Katherine Lange PhD , Gemma Lewis PhD
{"title":"The association between academic achievement goals and adolescent depressive symptoms: a prospective cohort study in Australia","authors":"Thomas Steare MSc , Prof Glyn Lewis PhD , Katherine Lange PhD , Gemma Lewis PhD","doi":"10.1016/S2352-4642(24)00051-8","DOIUrl":"10.1016/S2352-4642(24)00051-8","url":null,"abstract":"<div><h3>Background</h3><p>Students define academic competence across two axes: developing skills and understanding (mastery) versus comparisons with peers (performance), and achieving goals (approach) versus avoiding failure (avoidance). We aimed to examine the longitudinal association between achievement goals and adolescent depressive symptoms.</p></div><div><h3>Methods</h3><p>We analysed data from the Kindergarten (recruited at age 4–5 years; born between March, 1999, and February, 2000; recruited from March, 2004 to November, 2004) and Baby (recruited at age 0–1 years; born between March, 2003, and February, 2004; recruited from March, 2004 to January, 2005) cohorts of the Longitudinal Study of Australian Children. Participants were identified through the Medicare enrolment database and sampled using a randomised selection stratified by postcode to represent the Australian population. Achievement goals were measured at age 12–13 years with the Achievement Goal Questionnaire (ranges from 1 to 7 on each of the four subscales), and depressive symptoms with the Short Mood and Feelings Questionnaire (score ranges from 0 to 26, with higher scores indicating more severe symptoms) at ages 14–15 years (both cohorts) and 16–17 years (Kindergarten cohort only). Analyses were linear multilevel and traditional regressions, with confounder adjustment, for participants with available data on the exposures, confounders, and outcome.</p></div><div><h3>Findings</h3><p>We included 3200 participants (1585 female and 1615 male) from the Kindergarten cohort and 2671 participants (1310 female and 1361 male) from the Baby cohort. A 1-point increase in mastery-approach goals was associated with decreased depressive symptom severity score (Kindergarten, –0·33 [95% CI –0·52 to –0·15]; Baby, –0·29 [–0·54 to –0·03]), while a 1-point increase in mastery-avoidance goals was associated with increased depressive symptom severity score (Kindergarten, 0·35 [95% CI 0·21 to 0·48]; Baby, 0·44 [0·25 to 0·64]). A 1-point increase in performance-avoidance goals was associated with increased depressive symptom severity score in the Kindergarten cohort but not the Baby cohort (Kindergarten, 0·26 [95% CI 0·11 to 0·41]; Baby, –0·04 [–0·27 to 0·19]). We found little evidence of an association between depressive symptom severity and performance-approach goals.</p></div><div><h3>Interpretation</h3><p>Depressive symptoms in adolescents were associated with their achievement goals, which could be targetable risk factors for future trials to investigate whether school-based interventions that aim to enhance factors consistent with mastery goals (ie, learning skills and understanding the subject, rather than assessing competence in comparison to peers) could prevent depression in adolescents.</p></div><div><h3>Funding</h3><p>Sir Henry Dale Fellowship jointly funded by the Wellcome Trust and the Royal Society.</p></div>","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"8 6","pages":"Pages 413-421"},"PeriodicalIF":36.4,"publicationDate":"2024-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352464224000518/pdfft?md5=79fc38b9c76243731fe08eab8834f4ef&pid=1-s2.0-S2352464224000518-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140862796","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}