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儿科外科手术前期研究的核心成果集:国际利益相关者参与实践和儿科外科外科结果小组的共识报告
Paul A Stricker1, Laszlo Vutskits2,3, Jurgen C de Graaff4,5
1Professor, Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, USA. strickerp@chop.edu.
Anesthesiology
|July 31, 2025
概括
这项研究开发了儿科外科手术研究的核心结果集,确保以患者为中心的结果在临床试验中始终报告,以更好地评估干预.
科学领域:
- 儿科外科手术周边医学
- 临床试验方法论 临床试验方法论
- 患者报告的结果
背景情况:
- 标准化结果报告对于评估儿科外科手术期间干预措施至关重要.
- 患者和家长的观点对于确定有意义的临床研究结果至关重要.
- 该研究解决了在儿科外科护理中需要一致的结果措施的需求.
研究的目的:
- 开发和建立儿科外科手术周研究的核心成果集.
- 确保对患者及其监护人来说重要的结果得到优先考虑.
- 为了促进在儿科外科试验中对干预措施的一致和可比性评估.
主要方法:
- 采用了遵循COMET倡议指南的逐步方法.
- 广泛的国际利益相关者参与包括对患者,父母/监护人和医疗保健提供者的调查.
- 通过与专家代表和虚拟会议的德尔菲进程,最终确定了核心成果集.
主要成果:
- 1178名受访者参与了跨越多个国家的国际利益相关者调查.
- 对于新生儿,婴儿,儿童 (1-12岁) 和青少年 (13-17岁) 的核心结果被一致同意.
- 关键结局包括不良事件,疼痛管理和计划外医疗护理,还确定了康复质量和恢复功能.
结论:
- 对于四个不同的年龄组,成功确定了儿科外科手术周研究的核心结果集.
- 这些标准化结果应纳入未来的儿科外科手术研究.
- 开发的套件增强了儿科外科护理研究结果的相关性和可比性.
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