患者报告结局(Patient-Reported Outcomes,PRO)是基于"以患者为中心"的理念,由患者对自身健康状况、功能状态以及治疗感受等信息进行自主汇报,从而获得的一种主观结局指标,是对传统客观结局指标的有效补充.与传统可直接观察的客观结局不同,PRO研究的是一类不可观察、抽象的特征(如智力、疼痛、生活质量等),因此需要相应的测量理论予以指导,以实现对相关结局的精准、稳定测量.目前,国际上对PRO测量理论的研究有很多,其中国际组织"基于共识选择健康测量工具的标准"(COnsensus-based Standards for the selection of health Measurement INstruments,COSMIN)对该理论的研究最为详细和系统,其根据医学领域现有的理论学说,构建了基于COSMIN共识的理论体系.文章旨在对该理论体系进行系统介绍,希望可以为我国PRO的基础理论研究提供借鉴和参考.
A Study of Measurement Theory and Conceptual Models Based on the COSMIN for Patient-Reported Outcome (PRO)
Patient-Reported Outcomes (PRO) is a subjective outcome measure based on the concept of"patient-centered",in which patients report their own health status,functional status,treatment feelings and other information,which is an effective supplement to traditional objective outcome indicators. Different from the traditional objective outcomes that can be directly observed,PRO studies a kind of unobservable and abstract characteristics (such as intelligence,pain,quality of life,etc.),so it needs to be guided by corresponding measurement theories to achieve accurate and stable measurement of relevant outcomes. At present,there are many international studies on the measurement theory of PRO,among which the international organization COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) has the most detailed and systematic research on the theory,which constructs a theoretical system based on the consensus of COSMIN according to the existing theories in the medical field. It aims to systematically introduce the theoretical system,hoping to provide references for the basic theoretical research of PRO in China.
Patient-Reported Outcome Measures (PROM)Health-Related Quality of Life (HRQoL)conceptual modelconceptual frameworkmeasurement theory