GenderCOS项目:研究协议,用于制定两种国际核心成果集,用于生殖器性别确认手术
Philippine J Roijer1, Marleen S Vallinga1, Thomas E Pidgeon2
1Department of Plastic, Reconstructive and Hand Surgery, Amsterdam UMC - Amsterdam University Medical Centre, Amsterdam, The Netherlands.
本研究开发了生殖器性别确认手术 (gGAS) 的标准化结果集,以提高研究的一致性. 这些核心成果集 (COS) 将指导跨性别和性别多样性个体临床试验中的一致测量和报告.
科学领域:
- 医学研究 医学研究
- 外科手术的结果
- 跨性别者医疗保健服务
背景情况:
- 变性人和性别多样化个体中对生殖器性别确认手术 (gGAS) 的需求日益增加.
- 目前的文献缺乏用于评估gGAS程序的标准化结果.
- 缺乏共识阻碍了基于证据的治疗指南的制定.
研究的目的:
- 开发国际核心成果集 (COS) 进行男性化和女性化gGAS.
- 在gGAS临床试验中建立一致报告的最低结果集.
- 加强对gGAS临床结果和有效性的评估.
主要方法:
- 系统的文献审查以确定现有结果.
- 聚焦小组和采访跨性别人士.
- e-Delphi调查和与利益相关方的共识会议.
- 遵守有效性试验 (COMET) 准则中的核心结果措施.
主要成果:
- 为男性化和女性化gGAS开发两个平行核心成果集 (COS).
- 通过多阶段的共识识别和优先考虑关键结果.
- 为gGAS研究建立一个标准化的框架.
结论:
- 开发的COS将为gGAS研究提供最低一组结果.
- 标准化报告将促进科学进步和基于证据的指导方针.
- 国际共识确保了成果集的相关性和适用性.
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