中国全科医学 ›› 2026, Vol. 29 ›› Issue (28): 4058-4066.DOI: 10.12114/j.issn.1007-9572.2024.0505

• 热点研究 • 上一篇    下一篇

"以患者为中心"理念下患者体验数据的研究现状与应用

史梦龙1,2, 曹璐佳1,2, 吴晓蕾1,2, 庞博1,2, 王辉1,2, 庞稳泰1,2, 杨丰文1,2, 张俊华1,2,*()   

  1. 1.301617 天津市,天津中医药大学循证医学中心
    2.301617 天津市,国家药品监督管理局中医药循证评价重点实验室
  • 收稿日期:2025-11-20 修回日期:2026-06-09 出版日期:2026-10-05 发布日期:2026-09-02
  • 通讯作者: 张俊华

  • 作者贡献:

    史梦龙、张俊华负责研究命题的提出、文章的构思与设计、文献查阅和论文撰写;吴晓蕾、庞博负责查阅文献、表格的编辑和整理;王辉、庞稳泰、杨丰文负责研究资料的收集与整理、论文修订;曹璐佳、张俊华负责论文修订、整体质量把控、最终版本修订并对文章整体负责。

  • 基金资助:
    国家中医药多学科交叉创新团队项目(ZYYCXTD-D-D-202204); 国家中医药管理局青年岐黄学者支持项目(YL2202020414); 国家自然科学基金青年科学基金(82305433,82405612); 药品监管科学体系建设重点项目(RS2024Z004)

The Research Status and Application of Patient Experience Data in the "Patient-centered" Concept

SHI Menglong1,2, CAO Lujia1,2, WU Xiaolei1,2, PANG Bo1,2, WANG Hui1,2, PANG Wentai1,2, YANG Fengwen1,2, ZHAGN Junhua1,2,*()   

  1. 1. Evidence-based Medicine Center, College of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
    2. NMPA Key Laboratory for Evidence-based Evaluation of Traditional Chinese Medicine, Tianjin 301617, China
  • Received:2025-11-20 Revised:2026-06-09 Published:2026-10-05 Online:2026-09-02
  • Contact: ZHAGN Junhua

摘要: 患者作为疾病亲身经历者、临床试验受试者和医疗实践参与者,对疾病的体验及需求最为直接与明确。多国药品监管机构相继提出"以患者为中心"的理念,希望通过患者体验、感受和需求等患者体验数据,增加患者主动参与医疗决策、药物研发和临床试验的途径。本文通过系统梳理患者体验数据的演进历程,整理其定义、范围、来源和收集方法,剖析患者体验数据的应用价值及关键环节,为进一步研究提供参考。研究发现,尽管患者体验数据可广泛用于临床结局评估工具研制、药物研发和监管决策、完善临床试验设计等多个领域,但当前仍缺乏标准化的收集流程、规范化的识别和筛选技术及正确应用的方法学指导等。基于此,未来需要研究人员、患者群体和卫生行政部门等多方利益相关者通力合作,共同完善和推动患者体验数据的收集、识别、筛选和应用。

关键词: 卫生服务管理, 以患者为中心, 患者体验数据, 临床决策

Abstract:

Patients, as direct experiencers of illness, subjects of clinical trials, and participants in medical practices, have the most immediate and clear understanding of their disease experiences and health needs. Consequently, drug regulatory agencies in many countries have successively proposed the "patient-centered" concept, hoping to increase the pathways for patients to actively participate in medical decision-making, drug development, and clinical trials through patient experience, feelings, and needs, and other patient experience data. This article systematically reviews the evolution of patient experience data, organizes its definitions, scope, sources, and collection methods, analyzes the application value and key links of patient experience data, and provides references for further research. The study found that although patient experience data can be widely used in the development of clinical outcome assessment tools, drug development, regulatory decision-making, and the improvement of clinical trial design, there is still a lack of standardized collection processes, standardized identification and screening technologies, and correct application of methodological guidance. Based on this, future efforts require researchers, patient groups, and government agencies, and other stakeholders to work together to improve and promote the collection, identification, screening, and application of patient experience data.

Key words: Health services administration, Patient-centered, Patient experience data, Clinical decision-making

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