Doing challenging research studies in a patient-centred way: a qualitative study to inform a randomised controlled trial in the paediatric emergency care setting
Doing challenging research studies in a patient-centred way: a qualitative study to inform a randomised controlled trial in the paediatric emergency care setting
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DOI：
10.1136/bmjopen-2014-005045
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发表时间：
2014-01-01
期刊：
影响因子：
2.9
通讯作者：
Gamble, Carrol
中科院分区：
文献类型：
--
作者：
Woolfall, Kerry;Young, Bridget;Gamble, Carrol
目的：为设计随机对照试验（称为EcLiPSE）以改善惊厥性癫痫持续状态（CSE）儿童的治疗提供信息。EcLiPSE需要使用一个有争议的推迟consent process.Design：定性访谈和焦点小组study.Setting：8英国支持小组的父母的儿童谁有慢性或急性健康状况和经验的儿科急诊care.Participants：17父母，其中11人参加了电话采访（10母亲，1父亲）和6个焦点小组（5母亲，1父亲）。6父母（35%）丧失和7（41%）有孩子谁经历过癫痫发作，包括CSE.Results：大多数父母没有听说过的延迟同意，但他们支持使用，使紧急护理研究提供一个孩子的安全的进展不受影响的研究。有针对性的解释使家长放心，使他们的注意力集中在EcLiPSE解决他们的优先事项和关切的方面。这些方面包括正在研究的干预措施的安全性以及如何在常规临床实践中使用两种EcLiPSE干预措施。父母提出了建议，适当的时间招聘讨论，需要个性化的方法来招募丧亲父母和使用明确的书面information.Conclusions：我们的研究提供的信息，以帮助确保一个具有挑战性的试验是以病人为中心的设计。我们将利用我们的研究结果来帮助EcLiPSE从业者：与父母讨论潜在威胁的试验安全性信息，使用开放式问题和提示来确定他们的优先事项和关注点，并澄清书面试验信息的相关方面，以帮助理解和决策。
Objective: To inform the design of a randomised controlled trial (called EcLiPSE) to improve the treatment of children with convulsive status epilepticus (CSE). EcLiPSE requires the use of a controversial deferred consent process.Design: Qualitative interview and focus group study.Setting: 8 UK support groups for parents of children who have chronic or acute health conditions and experience of paediatric emergency care.Participants: 17 parents, of whom 11 participated in telephone interviews (10 mothers, 1 father) and 6 in a focus group (5 mothers, 1 father). 6 parents (35%) were bereaved and 7 (41%) had children who had experienced seizures, including CSE.Results: Most parents had not heard of deferred consent, yet they supported its use to enable the progress of emergency care research providing a child's safety was not compromised by the research. Parents were reassured by tailored explanation, which focused their attention on aspects of EcLiPSE that addressed their priorities and concerns. These aspects included the safety of the interventions under investigation and how both EcLiPSE interventions are used in routine clinical practice. Parents made recommendations about the appropriate timing of a recruitment discussion, the need to individualise approaches to recruiting bereaved parents and the use of clear written information.Conclusions: Our study provided information to help ensure that a challenging trial was patient centred in its design. We will use our findings to help EcLiPSE practitioners to: discuss potentially threatening trial safety information with parents, use open-ended questions and prompts to identify their priorities and concerns and clarify related aspects of written trial information to assist understanding and decision-making.