随机临床试验中环境结果的报告:范围审查的协议
Johanne Juul Petersen1, Linn Hemberg2,3, Lehana Thabane4,5,6
1Rigshospitalet Copenhagen Trial Unit, Copenhagen, Capital Region of Denmark, Denmark johanne.juul.petersen@ctu.dk.
BMJ open
|September 23, 2025
概括
本范围审查确定了临床试验中报告环境结果的方法,以为可持续医疗保健研究提供新的指导方针. 这些发现将指导制定标准协议项目:干预试验建议 (SPIRIT) -气候和环境结果 (ICE) 和报告试验综合标准 (CONSORT) -ICE.
科学领域:
- 环境科学 环境科学
- 临床试验方法论 临床试验方法论
- 医疗保健的可持续性 医疗保健的可持续性
背景情况:
- 医疗保健的可持续性需要在临床试验中评估临床结果并评估环境影响.
- 在随机试验中环境结果的现有报告和测量方法还没有得到很好的定义.
- 试验中的气候和环境结果实施小组将开发SPIRIT和CONSORT指南的扩展.
研究的目的:
- 在随机试验中对现有报告和测量环境结果的方法进行范围审查.
- 为SPIRIT-气候和环境成果 (ICE) 和CONSORT-ICE指导方针的制定提供信息.
- 加强将环境影响评估纳入临床试验设计和报告.
主要方法:
- 采用了两部分范围审查协议.
- 第1节:确定了干预对环境影响的指导方针,审查和研究.
- 第2节:在试验方案和结果中对环境结果的评估报告. 搜索包括医疗数据库,参考列表和注册表,由两位作者提取数据.
主要成果:
- 初步调查结果将确定报告环境成果的现行做法和差距.
- 该审查将综合测量试验环境中的环境影响的方法.
- 结果将成为开发SPIRIT-ICE和CONSORT-ICE扩展项目的初步项目清单的基础.
结论:
- 这一审查对于制定临床试验中环境结果的标准化报告准则至关重要.
- 这些发现将有助于将环境可持续性评估纳入医疗保健干预措施.
- 开发SPIRIT-ICE和CONSORT-ICE将促进更可持续的临床研究实践.
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