一个核心结果,用于对涉及深静脉的慢性静脉疾病的临床研究
George Hudson1, Maia Osborne-Grinter1, Aleksandra Staniszewska2
1Department of Vascular Surgery, North Bristol NHS Foundation Trust, Bristol, UK.
概括
针对涉及深静脉的慢性静脉疾病 (CVD) 干预,开发了一套核心结果 (COS). 这种标准化报告将改善对深静脉心血管疾病的治疗方法的比较.
科学领域:
- 血管医学 血管医学
- 临床试验方法论 临床试验方法论
背景情况:
- 慢性静脉疾病 (CVD) 具有显著的发病率和医疗保健成本.
- 缺乏标准化的结果报告阻碍了对深静脉心血管疾病干预措施的评估.
- 深静脉血栓形成后的血栓形成后综合征是心血管疾病的常见并发症.
研究的目的:
- 为评估深静脉心血管疾病干预措施的临床研究开发一个核心结果集 (COS).
- 建立标准化结果报告,以提高心脏病治疗的可比性.
- 确保以患者为中心的结果被纳入COS.
主要方法:
- 使用了有效性试验 (COMET) 方法论中的核心结果措施.
- 系统性审查和患者采访确定了最初的结果列表.
- 根据Delphi对患者和医疗保健专业人员的调查,根据重要性等级来精细化结果.
- 与国际专家和患者的最终共识会议建立了COS.
主要成果:
- 80个潜在的结果最初被确定并通过涉及233个和143个利益相关方的两轮Delphi流程来改进.
- 在29个至关重要的结果上达成共识.
- 最终的COS包括七个一般结果 (死亡,,VTE,出血,生活质量,疼痛,胀) 和六个程序特定的结果 (设备迁移,故障,通透性,成功,重新干预,血管并发症).
结论:
- 为深静脉心血管疾病干预建立了一个全面的COS.
- COS包括七个一般性结果和六个特定程序的结果.
- 这些结果的标准化报告将促进干预措施的直接比较,并推进深静脉心血管疾病的临床研究.
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