Impact of Legal Guardian Absence on Research Enrollment in the PICU.

IF 4 2区医学 Q1 CRITICAL CARE MEDICINE

Pediatric Critical Care Medicine Pub Date : 2024-09-01 Epub Date: 2024-06-17 DOI:10.1097/PCC.0000000000003551

Jennifer Armstrong, Jess Gibson, Katie O'Hearn, Dori-Ann Martin, Maysaa Assaf, Kusum Menon

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引用次数: 0

Abstract

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.

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法定监护人缺席对 PICU 研究注册的影响。

目的确定符合研究条件的儿童重症监护病房住院患儿的法定监护人在床边的频率：设计：前瞻性观察研究：地点：加拿大三家三级儿童重症监护病房：患者： 2021 年 9 月至 2023 年 3 月（研究地点 1）、2019 年 3 月至 2020 年 3 月和 2022 年 3 月至 2023 年 3 月（研究地点 2）以及 2019 年 3 月至 2020 年 3 月和 2020 年 7 月至 2021 年 11 月（研究地点 3）期间入住 PICU 的 211 名患者：测量和主要结果在每个中心，通过记录每次尝试的时间（分钟）来记录符合研究条件的患者同意就诊的持续时间。此外，还记录了父母在床边的频率以及监护人做出决定的能力。符合研究条件的患者中有 35% 在第一次尝试同意时没有法定监护人在床边。由于儿童的法定监护人无法做出同意的决定或无法在出院前联系到监护人，23%的接触过的患者没有被纳入研究：结论：PICU 中法定监护人的缺失对危重症儿童参与相关研究构成了障碍，并表明延迟同意或默示同意模式将有助于未来的危重症研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pediatric Critical Care Medicine 医学-危重病医学

CiteScore

7.40

自引率

14.60%

发文量

991

审稿时长

3-8 weeks

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.