家长对美国住院儿科前瞻性观察性研究的退出同意程序的意见

IF 2.3 Q2 MEDICINE, GENERAL & INTERNAL Pragmatic and Observational Research Pub Date : 2017-01-19 DOI:10.2147/POR.S126509
Danielle M. Fernandes, Allison P Roland, Marilyn C. Morris
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引用次数: 3

摘要

目的探讨美国儿科住院前瞻性观察性研究中家长关于选择退出同意的意见。研究设计:住院儿童的父母审查了一系列描述具有选择退出同意的假设观察性研究的讲义。一项口头调查探讨了家长对拟议的同意程序的看法。结果共有166名家长审阅了资料并完成了问卷调查。只有2/166的家长(1.2%)反对所描述的研究,另外10名家长(6.0%)表示担心孩子的医疗信息隐私。共有157名家长被问到:“用这份讲义告诉你这种研究可以吗?”——116人(74%)表示肯定,19人(12%)表示否定,21人(13%)表示不确定或中立。当父母被要求为观察性研究推荐一种特定的同意方法时,86位(52%)选择了选择加入方法,54位(33%)选择了选择退出方法,25位(15%)选择了“不需要同意”。父母的偏好与孩子是否入住重症监护病房和儿科病房之间没有显著的关联,并且根据所审查的讲义类型(通用与研究特异性)没有发现显著差异。结论:很少有家长对住院儿童前瞻性观察研究的假设选择退出同意过程表示反对。然而,当被要求推荐一种具体的同意方式时,大约一半的人选择了“选择加入”方式。这些数据表明,观察性住院研究的选择退出同意过程可能会被父母接受,但需要在现实环境中评估选择退出同意过程。
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Parental opinions regarding an opt-out consent process for inpatient pediatric prospective observational research in the US
Objective To explore parental opinions regarding opt-out consent for inpatient pediatric prospective observational research in the US. Study design A series of handouts describing hypothetical observational research studies with opt-out consent were reviewed by parents of hospitalized children. A verbal survey explored parental opinions about the proposed consent process. Results A total of 166 parents reviewed the handout and completed the survey. Only 2/166 parents (1.2%) objected to the study described and another 10 (6.0%) cited concern about the privacy of their child’s medical information. A total of 157 parents were asked “Is it okay to tell you about this kind of research using this handout?” – 116 (74%) responded positively, 19 (12%) responded negatively, and 21 (13%) made an indeterminate or neutral response. When parents were asked to recommend a specific consent approach for observational research, 86 (52%) chose an opt-in approach, 54 (33%) chose opt-out, and 25 (15%) chose “no consent needed”. There were no significant associations between parental preferences and whether the child was admitted to the intensive care unit vs. pediatric ward, and no significant difference found based on type of handout reviewed (generic vs. study-specific). Conclusion Few parents voiced objection to a hypothetical opt-out consent process for inpatient pediatric prospective observational research. When asked to recommend a specific consent approach, though, approximately half chose an opt-in approach. These data suggest that an opt-out consent process for observational inpatient research is likely to be acceptable to parents, but assessment of an opt-out consent process in a real-world setting is needed.
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Pragmatic and Observational Research
Pragmatic and Observational Research MEDICINE, GENERAL & INTERNAL-
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期刊介绍: Pragmatic and Observational Research is an international, peer-reviewed, open-access journal that publishes data from studies designed to closely reflect medical interventions in real-world clinical practice, providing insights beyond classical randomized controlled trials (RCTs). While RCTs maximize internal validity for cause-and-effect relationships, they often represent only specific patient groups. This journal aims to complement such studies by providing data that better mirrors real-world patients and the usage of medicines, thus informing guidelines and enhancing the applicability of research findings across diverse patient populations encountered in everyday clinical practice.
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