Objective This study aims to understand primary caregivers’ (PCG) experience with the informed consent (IC) process. Methods We conducted in-depth interviews with PCGs of paediatric patients who underwent a procedure requiring IC in the paediatric emergency department (PED) of a tertiary care paediatric centre in the USA, between January and March 2013 and between September 2013 and January 2014. We triangulated the qualitative findings from the PCG interviews with Likert-scale responses from the PCGs and with results from surveyed physicians. Results We included 14 PCG–physician dyads. Our results show that PCGs understand the importance of the IC process. They appreciated the calm demeanor of providers, and the clarity of their wording. PCGs felt that IC can add to the stress, and that it could be made simpler and timelier. PCGs also had varying extents of retention of the information provided. Conclusion This exploratory study suggests an overall positive IC experience of the PCGs while highlighting areas for improvement including a more thorough discussion of alternatives, a better assessment of knowledge transmission and retention by the PCG, and recognition of the PCG’s discomfort during decision making in a stressful environment.

中文翻译：

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初级护理人员在儿科急诊科知情同意过程中的经验：基于访谈的定性研究

目的 本研究旨在了解主要照顾者 (PCG) 在知情同意 (IC) 过程中的经验。方法 我们对 2013 年 1 月至 3 月以及 2013 年 9 月至 2014 年 1 月期间在美国三级保健儿科中心的儿科急诊科 (PED) 接受需要 IC 手术的儿科患者的 PCG 进行了深入访谈。将 PCG 访谈的定性结果与 PCG 的李克特量表反应以及接受调查的医生的结果进行三角测量。结果 我们纳入了 14 个 PCG-医师二元组。我们的结果表明，PCG 了解 IC 工艺的重要性。他们赞赏供应商的冷静举止和清晰的措辞。PCGs 认为 IC 可以增加压力，并且它可以变得更简单和更及时。PCG 对所提供的信息也有不同程度的保留。结论 这项探索性研究表明 PCG 的整体积极的 IC 体验，同时强调了需要改进的领域，包括更彻底地讨论替代方案，更好地评估 PCG 的知识传播和保留，以及认识到 PCG 在压力大的情况下决策过程中的不适环境。