对于患有慢性症状外周动脉疾病的患者来说,一个核心结局
Sabrina L M Zwetsloot1, Lotte Rijken2, Igor Koncar3
1Department of Surgery, Amsterdam UMC, location Vrije Universiteit Amsterdam, Amsterdam, The Netherlands; Amsterdam Cardiovascular Sciences, Atherosclerosis & Aortic Diseases, Amsterdam, The Netherlands.
概括
为慢性症状外周动脉疾病 (PAD) 患者开发了一套核心结局 (COS). 这份由11个结果组成的标准化清单将改善PAD的临床和AI研究.
科学领域:
- 心脏病学 心脏病学
- 医疗信息学 医疗信息学
- 临床研究方法论 临床研究方法论
背景情况:
- 周围动脉疾病 (PAD) 研究受到异质结果和选择性报告的影响.
- 标准化结果报告对于临床研究和人工智能 (AI) 预测模型的开发至关重要.
- 该VASCUL-AID项目旨在创建用于PAD患者心血管疾病进展的AI模型.
研究的目的:
- 为患有慢性症状PAD的患者建立一个核心结果组 (COS).
- 确保研究成果反映包括患者在内的所有利益相关者的需求.
- 在PAD的临床和AI研究中标准化结果报告.
主要方法:
- 这项研究遵循了有效性试验 (COMET) 中的核心结果措施 (Core Outcome Measures) 的建议.
- 从系统的文献审查和患者/医疗保健专业人员 (HCP) 焦点小组中生成了一个长长的结果列表.
- 一项Delphi研究涉及153名医疗保健工作者和92名患者,随后是一次专家共识会议,最终确定了COS.
主要成果:
- 最初的长列表包含67个结果.
- 德尔菲研究取得了85%的参与率.
- 最终的COS包括11个基本结果:死亡,心肌梗塞,大截肢,急性四肢缺血,血栓栓塞并发症,疾病进展,无痛步行距离,体力活动,与健康有关的生活质量,戒烟,以及医疗保健提供者的良好沟通.
结论:
- 这是首个专门为慢性症状PAD患者开发的COS.
- 建议在涉及PAD的临床试验和AI研究中采用COS.
- 标准化结果将提高PAD研究的质量和可比性.
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