{"title":"法定监护人缺席对 PICU 研究注册的影响。","authors":"Jennifer Armstrong, Jess Gibson, Katie O'Hearn, Dori-Ann Martin, Maysaa Assaf, Kusum Menon","doi":"10.1097/PCC.0000000000003551","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>To identify the frequency of which a legal guardian is at the bedside of children admitted to the PICU that are eligible for research studies.</p><p><strong>Design: </strong>A prospective, observational study.</p><p><strong>Setting: </strong>Three tertiary Canadian PICUs.</p><p><strong>Patients: </strong>Two hundred one patients were admitted to the PICU between September 2021 and March 2023 (site 1), from March 2019 to March 2020 and March 2022 to March 2023 (site 2), and from March 2019 to March 2020 and July 2020 to November 2021 (site 3).</p><p><strong>Interventions: </strong>None.</p><p><strong>Measurements and main results: </strong>At each center, the duration of consent encounters was recorded for patients eligible for research by documenting the length of each attempt (min). The frequency of parental presence at bedside and the ability for a guardian to make a decision were also recorded. Thirty-five percent of patients eligible for research did not have a legal guardian at the bedside on the first attempted consent encounter. Twenty-three percent of approached patients were not enrolled due to an inability for a consent decision to be made by the child's legal guardian or an inability to contact the guardian before discharge.</p><p><strong>Conclusions: </strong>The absence of legal guardians in the PICU poses a barrier to the enrollment of critically ill children in pertinent research studies and suggests that a model of deferred consent or implied consent would aid in the future of critical care research.</p>","PeriodicalId":19760,"journal":{"name":"Pediatric Critical Care Medicine","volume":null,"pages":null},"PeriodicalIF":4.0000,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Impact of Legal Guardian Absence on Research Enrollment in the PICU.\",\"authors\":\"Jennifer Armstrong, Jess Gibson, Katie O'Hearn, Dori-Ann Martin, Maysaa Assaf, Kusum Menon\",\"doi\":\"10.1097/PCC.0000000000003551\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>To identify the frequency of which a legal guardian is at the bedside of children admitted to the PICU that are eligible for research studies.</p><p><strong>Design: </strong>A prospective, observational study.</p><p><strong>Setting: </strong>Three tertiary Canadian PICUs.</p><p><strong>Patients: </strong>Two hundred one patients were admitted to the PICU between September 2021 and March 2023 (site 1), from March 2019 to March 2020 and March 2022 to March 2023 (site 2), and from March 2019 to March 2020 and July 2020 to November 2021 (site 3).</p><p><strong>Interventions: </strong>None.</p><p><strong>Measurements and main results: </strong>At each center, the duration of consent encounters was recorded for patients eligible for research by documenting the length of each attempt (min). The frequency of parental presence at bedside and the ability for a guardian to make a decision were also recorded. Thirty-five percent of patients eligible for research did not have a legal guardian at the bedside on the first attempted consent encounter. Twenty-three percent of approached patients were not enrolled due to an inability for a consent decision to be made by the child's legal guardian or an inability to contact the guardian before discharge.</p><p><strong>Conclusions: </strong>The absence of legal guardians in the PICU poses a barrier to the enrollment of critically ill children in pertinent research studies and suggests that a model of deferred consent or implied consent would aid in the future of critical care research.</p>\",\"PeriodicalId\":19760,\"journal\":{\"name\":\"Pediatric Critical Care Medicine\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":4.0000,\"publicationDate\":\"2024-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pediatric Critical Care Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/PCC.0000000000003551\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/6/17 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"CRITICAL CARE MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pediatric Critical Care Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/PCC.0000000000003551","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/6/17 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CRITICAL CARE MEDICINE","Score":null,"Total":0}
Impact of Legal Guardian Absence on Research Enrollment in the PICU.
Objectives: To identify the frequency of which a legal guardian is at the bedside of children admitted to the PICU that are eligible for research studies.
Design: A prospective, observational study.
Setting: Three tertiary Canadian PICUs.
Patients: Two hundred one patients were admitted to the PICU between September 2021 and March 2023 (site 1), from March 2019 to March 2020 and March 2022 to March 2023 (site 2), and from March 2019 to March 2020 and July 2020 to November 2021 (site 3).
Interventions: None.
Measurements and main results: At each center, the duration of consent encounters was recorded for patients eligible for research by documenting the length of each attempt (min). The frequency of parental presence at bedside and the ability for a guardian to make a decision were also recorded. Thirty-five percent of patients eligible for research did not have a legal guardian at the bedside on the first attempted consent encounter. Twenty-three percent of approached patients were not enrolled due to an inability for a consent decision to be made by the child's legal guardian or an inability to contact the guardian before discharge.
Conclusions: The absence of legal guardians in the PICU poses a barrier to the enrollment of critically ill children in pertinent research studies and suggests that a model of deferred consent or implied consent would aid in the future of critical care research.
期刊介绍:
Pediatric Critical Care Medicine is written for the entire critical care team: pediatricians, neonatologists, respiratory therapists, nurses, and others who deal with pediatric patients who are critically ill or injured. International in scope, with editorial board members and contributors from around the world, the Journal includes a full range of scientific content, including clinical articles, scientific investigations, solicited reviews, and abstracts from pediatric critical care meetings. Additionally, the Journal includes abstracts of selected articles published in Chinese, French, Italian, Japanese, Portuguese, and Spanish translations - making news of advances in the field available to pediatric and neonatal intensive care practitioners worldwide.