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使用新型采样设备招募接受心脏手术的新生儿和儿童参与研究面临的挑战及解决方案。

Challenges and solutions to recruitment of neonates and children having cardiac surgery into a study using a novel sampling device.

机构信息

Bristol Trials Centre, University of Bristol, Bristol, UK.

Bristol Heart Institute, University of Bristol, Bristol, UK.

出版信息

BMC Res Notes. 2022 Jun 11;15(1):202. doi: 10.1186/s13104-022-06088-y.

DOI:10.1186/s13104-022-06088-y
PMID:35690875
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9188008/
Abstract

OBJECTIVE

To narratively describe the challenges and solutions required in delivering a non-commercial study of children undergoing cardiac surgery using a novel subcutaneous hormone collection device.

RESULTS

The challenges faced by the research team are divided into those of conducting healthcare research in children and those specific to this study. Many of the issues of conducting healthcare research in children can and have been overcome by structural and institutional culture change-normalising and embedding research as part of good clinical care. The issues specific to insertion and maintenance of the novel collection device can be overcome by education and support of the clinical teams. The increased incentives and resources of commercial research may have overcome many of these.

摘要

目的

叙述在使用新型皮下激素采集装置对接受心脏手术的儿童进行非商业研究时所遇到的挑战和需要解决的问题。

结果

研究团队面临的挑战分为儿童保健研究相关挑战和本研究特有的挑战。通过结构和机构文化变革——将研究作为良好临床护理的一部分进行规范化和嵌入,可以解决许多在儿童中开展医疗保健研究的问题。新型采集装置的插入和维护问题可以通过对临床团队的教育和支持来解决。商业研究的更多激励措施和资源可能已经解决了其中的许多问题。

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本文引用的文献

1
The Peacock study: feasibility of the dynamic characterisation of the paediatric hypothalamic-pituitary-adrenal function during and after cardiac surgery.孔雀研究:在心脏手术期间和之后对儿科下丘脑-垂体-肾上腺功能进行动态特征描述的可行性。
BMC Cardiovasc Disord. 2020 May 25;20(1):245. doi: 10.1186/s12872-020-01516-y.
2
Normothermic versus hypothermic cardiopulmonary bypass in low-risk paediatric heart surgery: a randomised controlled trial.常温与低温体外循环在低危儿科心脏手术中的应用:一项随机对照试验。
Heart. 2019 Mar;105(6):455-464. doi: 10.1136/heartjnl-2018-313567. Epub 2018 Oct 15.
3
Automated 24-hours sampling of subcutaneous tissue free cortisol in humans.
人体皮下组织游离皮质醇的24小时自动采样
J Med Eng Technol. 2013 Apr;37(3):180-4. doi: 10.3109/03091902.2013.773096. Epub 2013 Apr 3.
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Factors affecting consent in pediatric critical care research.影响儿科重症监护研究中同意的因素。
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Health Technol Assess. 2011 Mar;15(15):1-116. doi: 10.3310/hta15150.
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Secondary sexual characteristics in boys: estimates from the national health and nutrition examination survey III, 1988-1994.男孩的第二性征:来自1988 - 1994年第三次全国健康与营养检查调查的估计数据
Arch Pediatr Adolesc Med. 2001 Sep;155(9):1022-8. doi: 10.1001/archpedi.155.9.1022.
7
Secondary sexual characteristics and menses in young girls seen in office practice: a study from the Pediatric Research in Office Settings network.门诊中所见年轻女孩的第二性征和月经:来自门诊儿科研究网络的一项研究
Pediatrics. 1997 Apr;99(4):505-12. doi: 10.1542/peds.99.4.505.