Pub Date : 2026-03-02DOI: 10.1001/jamapediatrics.2025.6490
Matthew Bourke, Claudia I Maddren, Franziska Sippel, George Thomas
Importance: Understanding the within-person association between daily screen use and sleep can help clarify whether this association reflects potentially causal effects or confounding factors.
Objective: To synthesize evidence on the within-person association between daily screen use and sleep among youth and to examine whether this association varies by screen type, sleep assessment method, or timing of screen use.
Data sources: Ovid MEDLINE, PsycINFO, SPORTDiscus, and Scopus were searched from inception to August 22, 2025, with forward and backward snowball searching. Data were analyzed in October 2025.
Study selection: Studies reporting on children, adolescents, and young adults aged 3 to 25 years that assessed sleep, measured screen time, and examined daily within-person associations between screen time and sleep were analyzed.
Data extraction and synthesis: Random-effects meta-analysis with cluster-robust variance estimation estimated pooled within-person correlations. Subgroup analyses examined moderating effects of screen type, assessment method, and timing.
Main outcomes and measures: The primary outcome was within-person correlations between screen time and sleep outcomes, including total sleep time, sleep onset, sleep onset latency, sleep efficiency, wake after sleep onset, and subjective sleep quality.
Results: A total of 25 studies reporting on 4562 participants were included. A small significant positive within-person correlation was found between screen time and sleep onset (r = 0.079; 95% CI, 0.010-0.149; P = .03), indicating later bedtimes on days with increased screen use. No significant associations were observed for total sleep time, sleep onset latency, sleep efficiency, wake after sleep onset, or subjective sleep quality. Moderator analyses revealed that the association between screen time and subjective sleep quality significantly differed by timing, with screen time after bedtime showing stronger negative correlation (r = -0.092) vs daily (r = -0.026) or evening (r = -0.005) assessments (P = .007). No other significant moderator effects were observed.
Conclusions and relevance: Per the results of this systematic review and meta-analysis, daily screen time has a small but significant within-person correlation with later sleep onset; however, short-term daily fluctuations in screen time appear to have minimal impact on sleep duration, efficiency, or quality. Screen time may delay bedtime but is not inherently detrimental to other aspects of sleep health in youth, contrasting with between-person studies showing stronger adverse associations.
{"title":"Within-Person Association Between Daily Screen Use and Sleep in Youth: A Systematic Review and Meta-Analysis.","authors":"Matthew Bourke, Claudia I Maddren, Franziska Sippel, George Thomas","doi":"10.1001/jamapediatrics.2025.6490","DOIUrl":"10.1001/jamapediatrics.2025.6490","url":null,"abstract":"<p><strong>Importance: </strong>Understanding the within-person association between daily screen use and sleep can help clarify whether this association reflects potentially causal effects or confounding factors.</p><p><strong>Objective: </strong>To synthesize evidence on the within-person association between daily screen use and sleep among youth and to examine whether this association varies by screen type, sleep assessment method, or timing of screen use.</p><p><strong>Data sources: </strong>Ovid MEDLINE, PsycINFO, SPORTDiscus, and Scopus were searched from inception to August 22, 2025, with forward and backward snowball searching. Data were analyzed in October 2025.</p><p><strong>Study selection: </strong>Studies reporting on children, adolescents, and young adults aged 3 to 25 years that assessed sleep, measured screen time, and examined daily within-person associations between screen time and sleep were analyzed.</p><p><strong>Data extraction and synthesis: </strong>Random-effects meta-analysis with cluster-robust variance estimation estimated pooled within-person correlations. Subgroup analyses examined moderating effects of screen type, assessment method, and timing.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was within-person correlations between screen time and sleep outcomes, including total sleep time, sleep onset, sleep onset latency, sleep efficiency, wake after sleep onset, and subjective sleep quality.</p><p><strong>Results: </strong>A total of 25 studies reporting on 4562 participants were included. A small significant positive within-person correlation was found between screen time and sleep onset (r = 0.079; 95% CI, 0.010-0.149; P = .03), indicating later bedtimes on days with increased screen use. No significant associations were observed for total sleep time, sleep onset latency, sleep efficiency, wake after sleep onset, or subjective sleep quality. Moderator analyses revealed that the association between screen time and subjective sleep quality significantly differed by timing, with screen time after bedtime showing stronger negative correlation (r = -0.092) vs daily (r = -0.026) or evening (r = -0.005) assessments (P = .007). No other significant moderator effects were observed.</p><p><strong>Conclusions and relevance: </strong>Per the results of this systematic review and meta-analysis, daily screen time has a small but significant within-person correlation with later sleep onset; however, short-term daily fluctuations in screen time appear to have minimal impact on sleep duration, efficiency, or quality. Screen time may delay bedtime but is not inherently detrimental to other aspects of sleep health in youth, contrasting with between-person studies showing stronger adverse associations.</p>","PeriodicalId":14683,"journal":{"name":"JAMA Pediatrics","volume":" ","pages":""},"PeriodicalIF":18.0,"publicationDate":"2026-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12954599/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147326052","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}
Pub Date : 2026-03-02DOI: 10.1001/jamapediatrics.2026.0015
Matthew L Friedman, Michael J Bell, Bonnie A Brooks, Adam S Himebauch, Asavari Kamerkar, Kerri LaRovere, Laura L Loftis, Jose A Pineda, Ahmed Said, Hitesh S Sandhu, Martin Stengelin, Catherine Demos, Mark S Wainwright, Alina N West, Allan Barnes, Allen D Everett, Ryan J Felling, Sue J Hong, Jennifer L Roem, Cynthia F Salorio, Derek K Ng, Melania M Bembea
Importance: Timely identification of acute brain injury (ABI) in children receiving extracorporeal membrane oxygenation (ECMO) support is critical for early neuroprotective interventions.
Objectives: To determine if elevations in plasma glial fibrillary acidic protein (GFAP), neurofilament light chain (NfL), and tau levels in children receiving ECMO precede new ABI confirmed by neuroimaging, and if they are associated with mortality and functional outcomes.
Design, setting, and participants: This was a prospective observational cohort study conducted from 2019 to 2023, with 18-month follow-up completed in 2025. Children aged 2 days to younger than 18 years at ECMO cannulation were recruited from 11 US children's hospitals. Study data were analyzed from May to August 2025.
Exposures: GFAP, NfL, and tau measured in plasma samples collected serially during the ECMO course.
Main outcomes and measures: Unfavorable short-term outcome was a composite of in-hospital mortality or discharge Pediatric Cerebral Performance Category score of 3 or greater with decline of at least 1 point from baseline. Unfavorable long-term outcome was a composite of mortality or Vineland Adaptive Behavior Scales, third edition, composite score less than 85 at 18 months after ECMO.
Results: This study included 219 participants (224 ECMO courses; 1089 serial blood samples). Median age was 11 months (IQR, 30 days-9 years), and 121 (54%) were male. Among 60 ECMO courses with new ABI during the ECMO course, GFAP and NfL levels increased significantly, by 6.4% (95% CI, 1.4%-11.6%) and 16.1% (95% CI, 10.5%-22.0%), respectively, for each 24 hours preceding neuroimaging diagnosis of new ABI. Geometric means for GFAP, NfL, and tau were all significantly higher in those with unfavorable vs favorable outcome at hospital discharge for both the first sample receiving ECMO and peak levels during ECMO support. A 2-fold increase in GFAP and NfL levels from first sample receiving ECMO was significantly associated with unfavorable outcome after adjusting for baseline GFAP and NfL levels, age, and ECMO indication (GFAP adjusted hazard ratio [aHR], 1.48; 95% CI, 1.22-1.79; NfL aHR, 1.43; 95% CI, 1.14-1.79). Similar models for tau showed no significant association with outcomes.
Conclusions and relevance: Results suggest that GFAP and NfL may be promising candidates for real-time neurologic monitoring in children receiving ECMO and may aid in diagnosis, association with outcomes, and potentially guiding neuroprotective strategies.
{"title":"Plasma Biomarkers of Brain Injury in Critically Ill Children Receiving Extracorporeal Membrane Oxygenation.","authors":"Matthew L Friedman, Michael J Bell, Bonnie A Brooks, Adam S Himebauch, Asavari Kamerkar, Kerri LaRovere, Laura L Loftis, Jose A Pineda, Ahmed Said, Hitesh S Sandhu, Martin Stengelin, Catherine Demos, Mark S Wainwright, Alina N West, Allan Barnes, Allen D Everett, Ryan J Felling, Sue J Hong, Jennifer L Roem, Cynthia F Salorio, Derek K Ng, Melania M Bembea","doi":"10.1001/jamapediatrics.2026.0015","DOIUrl":"10.1001/jamapediatrics.2026.0015","url":null,"abstract":"<p><strong>Importance: </strong>Timely identification of acute brain injury (ABI) in children receiving extracorporeal membrane oxygenation (ECMO) support is critical for early neuroprotective interventions.</p><p><strong>Objectives: </strong>To determine if elevations in plasma glial fibrillary acidic protein (GFAP), neurofilament light chain (NfL), and tau levels in children receiving ECMO precede new ABI confirmed by neuroimaging, and if they are associated with mortality and functional outcomes.</p><p><strong>Design, setting, and participants: </strong>This was a prospective observational cohort study conducted from 2019 to 2023, with 18-month follow-up completed in 2025. Children aged 2 days to younger than 18 years at ECMO cannulation were recruited from 11 US children's hospitals. Study data were analyzed from May to August 2025.</p><p><strong>Exposures: </strong>GFAP, NfL, and tau measured in plasma samples collected serially during the ECMO course.</p><p><strong>Main outcomes and measures: </strong>Unfavorable short-term outcome was a composite of in-hospital mortality or discharge Pediatric Cerebral Performance Category score of 3 or greater with decline of at least 1 point from baseline. Unfavorable long-term outcome was a composite of mortality or Vineland Adaptive Behavior Scales, third edition, composite score less than 85 at 18 months after ECMO.</p><p><strong>Results: </strong>This study included 219 participants (224 ECMO courses; 1089 serial blood samples). Median age was 11 months (IQR, 30 days-9 years), and 121 (54%) were male. Among 60 ECMO courses with new ABI during the ECMO course, GFAP and NfL levels increased significantly, by 6.4% (95% CI, 1.4%-11.6%) and 16.1% (95% CI, 10.5%-22.0%), respectively, for each 24 hours preceding neuroimaging diagnosis of new ABI. Geometric means for GFAP, NfL, and tau were all significantly higher in those with unfavorable vs favorable outcome at hospital discharge for both the first sample receiving ECMO and peak levels during ECMO support. A 2-fold increase in GFAP and NfL levels from first sample receiving ECMO was significantly associated with unfavorable outcome after adjusting for baseline GFAP and NfL levels, age, and ECMO indication (GFAP adjusted hazard ratio [aHR], 1.48; 95% CI, 1.22-1.79; NfL aHR, 1.43; 95% CI, 1.14-1.79). Similar models for tau showed no significant association with outcomes.</p><p><strong>Conclusions and relevance: </strong>Results suggest that GFAP and NfL may be promising candidates for real-time neurologic monitoring in children receiving ECMO and may aid in diagnosis, association with outcomes, and potentially guiding neuroprotective strategies.</p>","PeriodicalId":14683,"journal":{"name":"JAMA Pediatrics","volume":" ","pages":""},"PeriodicalIF":18.0,"publicationDate":"2026-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12954597/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147326016","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}
Pub Date : 2026-03-02DOI: 10.1001/jamapediatrics.2026.0188
{"title":"Error in Table and Text.","authors":"","doi":"10.1001/jamapediatrics.2026.0188","DOIUrl":"10.1001/jamapediatrics.2026.0188","url":null,"abstract":"","PeriodicalId":14683,"journal":{"name":"JAMA Pediatrics","volume":" ","pages":""},"PeriodicalIF":18.0,"publicationDate":"2026-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12954593/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147326037","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}
Pub Date : 2026-03-01DOI: 10.1001/jamapediatrics.2026.0163
{"title":"Error in Conflict of Interest Disclosures.","authors":"","doi":"10.1001/jamapediatrics.2026.0163","DOIUrl":"10.1001/jamapediatrics.2026.0163","url":null,"abstract":"","PeriodicalId":14683,"journal":{"name":"JAMA Pediatrics","volume":"180 3","pages":"348"},"PeriodicalIF":18.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12954533/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147326126","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}
Pub Date : 2026-03-01DOI: 10.1001/jamapediatrics.2025.5964
Lauren E Wisk, Kathryn M Leifheit
{"title":"Important Role of Social Policies to Prevent Child Maltreatment.","authors":"Lauren E Wisk, Kathryn M Leifheit","doi":"10.1001/jamapediatrics.2025.5964","DOIUrl":"10.1001/jamapediatrics.2025.5964","url":null,"abstract":"","PeriodicalId":14683,"journal":{"name":"JAMA Pediatrics","volume":" ","pages":"238-239"},"PeriodicalIF":18.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146052120","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}
Pub Date : 2026-02-25DOI: 10.1001/jamapediatrics.2026.0122
Ami Baba, Martin Offringa, Lindsay A. Thompson
This JAMA Pediatrics Patient Page describes how new guidance aiming to improve reporting of clinical trials may help young people and parents find information to make the right health care decisions for them.
{"title":"What Young People and Parents Need to Know When Reading Clinical Trial Reports","authors":"Ami Baba, Martin Offringa, Lindsay A. Thompson","doi":"10.1001/jamapediatrics.2026.0122","DOIUrl":"https://doi.org/10.1001/jamapediatrics.2026.0122","url":null,"abstract":"This <jats:italic toggle=\"yes\">JAMA Pediatrics</jats:italic> Patient Page describes how new guidance aiming to improve reporting of clinical trials may help young people and parents find information to make the right health care decisions for them.","PeriodicalId":14683,"journal":{"name":"JAMA Pediatrics","volume":"98 1","pages":""},"PeriodicalIF":26.1,"publicationDate":"2026-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147278826","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}
Pub Date : 2026-02-25DOI: 10.1001/jamapediatrics.2026.0104
Ami Baba, Maureen Smith, Beth K. Potter, An-Wen Chan, David Moher, Alene Toulany, Amanda Doherty-Kirby, Begonya Nafria Escalera, Catherine Stratton, Chris Gale, Colin Macarthur, Diane Purper-Ouakil, Edmund Juszczak, Eyal Cohen, Giorgio Reggiardo, Jennifer Preston, Jérémie F. Cohen, Julia Upton, Karel Allegaert, Katelynn Boerner, Kayur Mehta, Kim An Nguyen, Kimberly Courtney, Lisa Hartling, Menelaos Konstantinidis, Michal Odermarsky, Nancy J. Butcher, Niina Kolehmainen, Patricia E. Longmuir, Peter J. Gill, Piet Leroy, Reinhard Feneberg, Ramesh Poluru, Shaun K. Morris, Stefan J. Friedrichsdorf, Tanya Chute Nagy, Terry P. Klassen, Thierry Lacaze-Masmonteil, Wes Onland, Martin Offringa
Importance Randomized controlled trials (RCTs) in children and adolescents provide evidence for patients, families, researchers, clinicians, regulators, funders, policymakers, and other interest holders to inform decisions about health care interventions and improve outcomes for young patients and their families. To critically evaluate, interpret, and apply trial results, readers require access to a complete and transparent report of what was planned, done, and found, taking unique considerations specific to children and adolescents into account. Harmonized guidance based on evidence and consensus is needed to optimize standardized reporting and reduce research waste in pediatric RCTs. Objective To develop a pediatric reporting guideline extension to the Consolidated Standards of Reporting Trials (CONSORT) 2025 guideline, CONSORT–Children and Adolescents (CONSORT-C) 2026, that supports comprehensive reporting and enhances the transparency, reproducibility, accuracy, and utility of published pediatric RCT reports. Evidence Review The Enhancing the Quality of Transparency of Health Research (EQUATOR) Network’s published framework primarily informed the development of CONSORT-C 2026. A literature review was conducted to generate a list of candidate reporting items. To obtain direct input from young people and family caregivers throughout the project, a Youth Advisory Group and a Family Caregiver Advisory Group were formed. An international Delphi study with a priori consensus thresholds, consensus meeting, group writing of the explanation and elaboration paper, and pilot testing were conducted. Main Outcomes and Measures Harmonized guidance based on evidence and consensus is needed to optimize standardized reporting and reduce research waste in pediatric RCTs. As an extension to the CONSORT 2025 statement, the CONSORT-C 2026 reporting guideline aims to improve the quality and completeness of reporting of pediatric RCTs that involve participants aged 0 to 19 years. Findings The new CONSORT-C 2026 guideline is an extension to the updated CONSORT 2025 statement and adds reporting items applicable to pediatric RCT reports involving children and adolescents aged 0 to 19 years. Developed in partnership with young people (aged 10-24 years) and family caregivers, CONSORT-C 2026 comprises 13 new items recommended to be reported in pediatric RCT reports in addition to the CONSORT 2025 items. The 13 new reporting items include 1 youth-generated and 6 youth-endorsed items. CONSORT-C 2026 can be considered a minimum set of reporting items applicable to pediatric RCT reports reflecting the priorities of clinicians, researchers, young people, family caregivers, and other interest holders. Conclusions and Relevance Widespread implementation and uptake of CONSORT-C 2026 should optimize the usability of trial results for these populations, improve the reproducibility of trial results, and reduce research waste.
儿童和青少年的随机对照试验(RCTs)为患者、家庭、研究人员、临床医生、监管机构、资助者、政策制定者和其他利益相关者提供了证据,以告知有关卫生保健干预措施的决策,并改善年轻患者及其家庭的结果。为了批判性地评价、解释和应用试验结果,读者需要获得一份完整和透明的报告,其中包括计划、实施和发现的内容,同时考虑到儿童和青少年的特殊考虑。需要基于证据和共识的统一指导,以优化儿科随机对照试验的标准化报告并减少研究浪费。目的:为《联合试验报告标准2025》(CONSORT)指南《CONSORT- children and Adolescents》(CONSORT- c) 2026制定儿科报告指南,以支持综合报告,提高已发表儿科随机对照试验报告的透明度、可重复性、准确性和实用性。提高卫生研究透明度质量(EQUATOR)网络公布的框架主要为conber - c 2026的开发提供了信息。进行文献回顾以生成候选报告项目列表。为了在整个项目中获得年轻人和家庭照顾者的直接意见,成立了一个青年咨询小组和一个家庭照顾者咨询小组。通过先验共识阈值、共识会议、解释和阐述论文的小组写作和试点测试进行了国际德尔菲研究。需要基于证据和共识的统一指导,以优化儿科随机对照试验的标准化报告并减少研究浪费。作为CONSORT 2025声明的延伸,CONSORT- c 2026报告指南旨在提高涉及0 - 19岁受试者的儿科随机对照试验报告的质量和完整性。新的CONSORT- c 2026指南是更新后的CONSORT 2025声明的扩展,增加了适用于涉及0 - 19岁儿童和青少年的儿科RCT报告的报告项目。CONSORT- c 2026是与年轻人(10-24岁)和家庭照顾者合作开发的,除CONSORT 2025项目外,还包括13个建议在儿科RCT报告中报告的新项目。13个新的报告项目包括1个青年产生的项目和6个青年认可的项目。concont - c 2026可被视为适用于儿科RCT报告的最低报告项目集,反映了临床医生、研究人员、年轻人、家庭照顾者和其他利益相关者的优先事项。广泛实施和采用concont - c 2026应优化试验结果在这些人群中的可用性,提高试验结果的可重复性,并减少研究浪费。
{"title":"CONSORT–Children and Adolescents (CONSORT-C) 2026 Extension Statement","authors":"Ami Baba, Maureen Smith, Beth K. Potter, An-Wen Chan, David Moher, Alene Toulany, Amanda Doherty-Kirby, Begonya Nafria Escalera, Catherine Stratton, Chris Gale, Colin Macarthur, Diane Purper-Ouakil, Edmund Juszczak, Eyal Cohen, Giorgio Reggiardo, Jennifer Preston, Jérémie F. Cohen, Julia Upton, Karel Allegaert, Katelynn Boerner, Kayur Mehta, Kim An Nguyen, Kimberly Courtney, Lisa Hartling, Menelaos Konstantinidis, Michal Odermarsky, Nancy J. Butcher, Niina Kolehmainen, Patricia E. Longmuir, Peter J. Gill, Piet Leroy, Reinhard Feneberg, Ramesh Poluru, Shaun K. Morris, Stefan J. Friedrichsdorf, Tanya Chute Nagy, Terry P. Klassen, Thierry Lacaze-Masmonteil, Wes Onland, Martin Offringa","doi":"10.1001/jamapediatrics.2026.0104","DOIUrl":"https://doi.org/10.1001/jamapediatrics.2026.0104","url":null,"abstract":"Importance Randomized controlled trials (RCTs) in children and adolescents provide evidence for patients, families, researchers, clinicians, regulators, funders, policymakers, and other interest holders to inform decisions about health care interventions and improve outcomes for young patients and their families. To critically evaluate, interpret, and apply trial results, readers require access to a complete and transparent report of what was planned, done, and found, taking unique considerations specific to children and adolescents into account. Harmonized guidance based on evidence and consensus is needed to optimize standardized reporting and reduce research waste in pediatric RCTs. Objective To develop a pediatric reporting guideline extension to the Consolidated Standards of Reporting Trials (CONSORT) 2025 guideline, CONSORT–Children and Adolescents (CONSORT-C) 2026, that supports comprehensive reporting and enhances the transparency, reproducibility, accuracy, and utility of published pediatric RCT reports. Evidence Review The Enhancing the Quality of Transparency of Health Research (EQUATOR) Network’s published framework primarily informed the development of CONSORT-C 2026. A literature review was conducted to generate a list of candidate reporting items. To obtain direct input from young people and family caregivers throughout the project, a Youth Advisory Group and a Family Caregiver Advisory Group were formed. An international Delphi study with a priori consensus thresholds, consensus meeting, group writing of the explanation and elaboration paper, and pilot testing were conducted. Main Outcomes and Measures Harmonized guidance based on evidence and consensus is needed to optimize standardized reporting and reduce research waste in pediatric RCTs. As an extension to the CONSORT 2025 statement, the CONSORT-C 2026 reporting guideline aims to improve the quality and completeness of reporting of pediatric RCTs that involve participants aged 0 to 19 years. Findings The new CONSORT-C 2026 guideline is an extension to the updated CONSORT 2025 statement and adds reporting items applicable to pediatric RCT reports involving children and adolescents aged 0 to 19 years. Developed in partnership with young people (aged 10-24 years) and family caregivers, CONSORT-C 2026 comprises 13 new items recommended to be reported in pediatric RCT reports in addition to the CONSORT 2025 items. The 13 new reporting items include 1 youth-generated and 6 youth-endorsed items. CONSORT-C 2026 can be considered a minimum set of reporting items applicable to pediatric RCT reports reflecting the priorities of clinicians, researchers, young people, family caregivers, and other interest holders. Conclusions and Relevance Widespread implementation and uptake of CONSORT-C 2026 should optimize the usability of trial results for these populations, improve the reproducibility of trial results, and reduce research waste.","PeriodicalId":14683,"journal":{"name":"JAMA Pediatrics","volume":"16 1","pages":""},"PeriodicalIF":26.1,"publicationDate":"2026-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147278820","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}
Pub Date : 2026-02-25DOI: 10.1001/jamapediatrics.2026.0113
Ami Baba, Maureen Smith, Beth K. Potter, An-Wen Chan, David Moher, Alene Toulany, Amanda Doherty-Kirby, Begonya Nafria Escalera, Catherine Stratton, Chris Gale, Colin Macarthur, Diane Purper-Ouakil, Edmund Juszczak, Eyal Cohen, Giorgio Reggiardo, Jennifer Preston, Jérémie F. Cohen, Julia Upton, Karel Allegaert, Katelynn Boerner, Kayur Mehta, Kim An Nguyen, Kimberly Courtney, Lisa Hartling, Menelaos Konstantinidis, Michal Odermarsky, Nancy J. Butcher, Niina Kolehmainen, Patricia E. Longmuir, Peter J. Gill, Piet Leroy, Reinhard Feneberg, Ramesh Poluru, Shaun K. Morris, Stefan J. Friedrichsdorf, Tanya Chute Nagy, Terry P. Klassen, Thierry Lacaze-Masmonteil, Wes Onland, Martin Offringa
Importance Key information is often omitted from pediatric randomized controlled trial (RCT) protocols, including details on dose adjustments of interventions based on age, body surface area, or weight; developmental appropriateness of trial outcome measures and processes; or strategies to minimize participants’ anxiety and pain. These deficiencies impair the planning and implementation of potentially impactful trials for children and adolescents. Appropriate guidance is needed to support harmonized, comprehensive reporting of pediatric RCT protocols involving participants aged 0 to 19 years. Developed in partnership with young people (aged 10-24 years) and family caregivers, the Standard Protocol Items: Recommendations for Interventional Trials–Children and Adolescents (SPIRIT-C) 2026 consists of 17 new items recommended to be reported in addition to the SPIRIT 2025 items in pediatric RCT protocols. Objective To develop a pediatric reporting guideline extension to the SPIRIT 2025 guideline, SPIRIT-C 2026, that supports comprehensive and transparent reporting of pediatric RCT protocols. Evidence Review The methodological framework for developing reporting guidelines published by the EQUATOR Network was implemented to develop a pediatric extension to the SPIRIT 2025 guidelines called SPIRIT-C 2026. A list of candidate reporting items was generated from the literature, and a Youth Advisory Group and a Family Caregiver Advisory Group contributed vital input throughout the project. An international Delphi study with a priori consensus thresholds, a consensus meeting, group writing of the explanation and elaboration paper, and pilot testing of the draft guideline were conducted. Main Outcomes and Measures SPIRIT-C 2026 details key reporting items applicable to pediatric RCT protocols involving children and adolescents aged 0 to 19 years. All relevant items are aligned with those in Consolidated Standards of Reporting Trials–Children and Adolescents 2026, a new reporting guideline for completed pediatric RCTs. Findings SPIRIT-C 2026 consists of a checklist with 17 new reporting items for reporting pediatric RCT protocols; 4 items are youth generated and 6 youth endorsed. These can be considered a minimum set of reporting items pertinent to pediatric RCT protocols that are relevant to various interest holders, including young people, family caregivers, researchers, pediatric trialists, ethics committees, regulators, funders, and journal editors. Widespread implementation and uptake of SPIRIT-C 2026 should enhance the quality and usefulness of protocols for RCTs that involve participants from birth through adolescence and ultimately foster high-quality pediatric trials. Conclusions and Relevance Inclusion of these SPIRIT-C 2026 items supports comprehensive, meaningful, relevant, and transparent reporting, which can improve both the quality and usefulness of pediatric RCT protocols. RCT protocols contain essential details needed to understand and evaluate
儿童随机对照试验(RCT)方案经常遗漏关键信息,包括基于年龄、体表面积或体重的干预措施剂量调整的细节;试验结果测量和过程的发展适宜性;或者最小化参与者焦虑和痛苦的策略。这些缺陷妨碍了对儿童和青少年有潜在影响的试验的规划和实施。需要适当的指导,以支持对涉及0至19岁参与者的儿科RCT方案进行统一、全面的报告。与年轻人(10-24岁)和家庭照顾者合作制定的标准方案项目:介入性试验建议-儿童和青少年(SPIRIT- c) 2026包括除SPIRIT 2025在儿科RCT方案中的项目外建议报告的17个新项目。目的制定SPIRIT 2025指南的儿科报告指南(SPIRIT- c 2026),以支持儿科RCT方案的全面透明报告。实施赤道网络发布的制定报告指南的方法框架是为了制定SPIRIT 2025指南的儿科延伸部分,称为SPIRIT- c 2026。从文献中生成了候选报告项目列表,青年咨询小组和家庭照顾者咨询小组在整个项目中提供了重要的输入。进行了一项具有先验共识阈值的国际德尔菲研究、一次共识会议、解释和阐述文件的小组编写以及准则草案的试点测试。SPIRIT-C 2026详细介绍了适用于0 - 19岁儿童和青少年的儿科RCT方案的关键报告项目。所有相关项目均符合《试验报告综合标准-儿童和青少年2026》,这是一项针对已完成儿科随机对照试验的新报告指南。SPIRIT-C 2026包括一份包含17个儿科RCT方案报告新项目的清单;4个项目是由青少年产生的,6个项目是由青少年赞助的。这些可被视为与儿童RCT方案相关的最低报告项目集,与各种利益相关者相关,包括年轻人、家庭照顾者、研究人员、儿科试验学家、伦理委员会、监管机构、资助者和期刊编辑。SPIRIT-C 2026的广泛实施和采用应提高涉及从出生到青春期参与者的随机对照试验方案的质量和有用性,并最终促进高质量的儿科试验。纳入这些SPIRIT-C 2026项目支持全面、有意义、相关和透明的报告,可以提高儿科RCT方案的质量和有用性。RCT方案包含理解和评估试验计划目标、设计、数据收集方法、监测、数据分析和参与者安全所需的基本细节。
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