Department of Pediatrics, Columbia University, New York, NY, USA.
Pediatr Crit Care Med. 2011 Nov;12(6):e266-70. doi: 10.1097/PCC.0b013e31820aba87.
No uniform guidelines exist regarding informed consent for bedside procedures in the intensive care unit (ICU), and practice varies widely between institutions. Neither guidelines nor data exist to help pediatric ICU (PICU) directors craft procedural consent policies. We conducted an exploratory study to explore the impact on patients, parents, and healthcare providers of a requirement for informed consent for bedside procedures in the PICU and to describe parental and provider beliefs regarding procedural consent.
Prospective, observational and survey-based exploratory study.
Single-center, tertiary care, university-affiliated PICU.
Children admitted to the PICU and undergoing an invasive bedside procedure.
None.
During two 14-day periods, all bedside procedures conducted in the PICU were identified. Consent forms were reviewed, and parents and the healthcare providers who participated in the consent discussion were invited to complete a brief verbal questionnaire regarding the consent process. Quantitative data are presented using descriptive statistics and qualitative data were analyzed using thematic coding. During the study period, 50 bedside procedures were performed. Informed consent was not obtained for two emergent procedures. Only the first procedure on a child was included in the study, leaving 41 informed consent discussions for analysis. Consent was obtained in person in 33 cases (80%) and over the phone for the remainder. The median reported duration of the informed consent discussion was 5 mins. Ninety-six percent of parents correctly recalled what procedure had been performed, and 92% correctly recalled at least one reason for the procedure, but only 58% recalled at least one risk of the procedure. Parents viewed themselves as the primary decision makers, and many parents believed that their refusal of consent would be honored even if it would potentially harm the child. However, no parent refused or even significantly resisted giving consent for a procedure recommended by their child's healthcare provider.
Parental consent for invasive bedside procedures in the PICU can be obtained reliably and without posing an undue time burden on healthcare providers. Most parents perceive a real decision making opportunity surrounding invasive procedures, but agree readily to the recommendations of their healthcare providers.
重症监护病房（ICU）床边操作的知情同意书没有统一的指南，各机构的实践差异很大。既没有指导方针，也没有数据可以帮助儿科重症监护病房（PICU）主任制定程序性同意政策。我们进行了一项探索性研究，以探讨在 PICU 进行床边操作时需要知情同意对患者、家长和医疗保健提供者的影响，并描述家长和提供者对程序同意的看法。
前瞻性、观察性和基于调查的探索性研究。
单中心、三级保健、大学附属 PICU。
入住 PICU 并接受侵入性床边操作的儿童。
无。
在两个为期 14 天的期间，确定了在 PICU 进行的所有床边操作。审查了同意书，并邀请参与同意讨论的家长和医疗保健提供者完成一份简短的口头问卷，了解同意过程。定量数据采用描述性统计方法表示，定性数据采用主题编码进行分析。在研究期间，共进行了 50 次床边操作。有两个紧急程序没有获得知情同意。只有孩子的第一次操作被包括在研究中，留下 41 次知情同意讨论进行分析。33 例（80%）以当面方式获得同意，其余通过电话获得同意。报告的知情同意讨论的中位数持续时间为 5 分钟。96%的家长正确回忆起进行了什么程序，92%正确回忆起至少一个程序的原因，但只有 58%正确回忆起至少一个程序的风险。家长认为自己是主要决策者，许多家长认为，即使这可能对孩子造成伤害，他们拒绝同意也会得到尊重。然而，没有家长拒绝甚至强烈抵制其孩子的医疗保健提供者推荐的程序。
可以可靠地获得 PICU 侵入性床边操作的家长同意，而不会给医疗保健提供者带来不必要的时间负担。大多数家长认为在进行侵入性操作时，他们有真正的决策机会，但他们很容易接受医疗保健提供者的建议。
