Zhang Qi, Chen Xiao, Kang YiChen, Yu JingXian, Zhang YuXia
Department of Nursing, Zhongshan Hospital of Fudan University, Shanghai, 200032, People's Republic of China.
Fudan University Nursing School, Shanghai, 200032, People's Republic of China.
Qual Life Res. 2025 May;34(5):1179-1193. doi: 10.1007/s11136-025-03893-3. Epub 2025 Jan 20.
To identify instruments used to measure patient-reported outcomes after LT, and critically evaluate their measurement properties.
Five online databases were searched to find English-language LT-specific PROMs from their inception to October 2024. Studies describing the development or validation of PROMs were included. Two reviewers extracted and synthesized information about the characteristics of the studies and instruments. The methodological quality of the included studies was evaluated using the Consensus-Based Standards for the Selection of Health Measurement Instrument (COSMIN). Two reviewers independently evaluated the methodological quality of the included instruments.
A total of 17 studies involving 14 PROMs met the inclusion criteria and were included in this review. The included PROMs assessed a range of outcomes, including health-related quality of life, therapeutic adherence, symptom experience, social participation, feeling for the donor, satisfaction and informational needs. None of the 14 scales reported the ten boxes of measurement properties outlined by the COSMIN. Among all the measurement properties, content validity from expert (64.3%, 9/14) and internal consistency (57.1%, 8/14) were the two most frequently measured attributes. Less than half of the studies evaluated the content validity from the patients' perspective. Four studies evaluated structural validity using exploratory factor analysis, but no study conducted confirmatory factor analysis or used IRT method to measure the structural validity.
This systematic review provided an overall picture and detailed analysis of LT-specific PROMs, and highlighted the paucity of well-developed and validated instruments. Further studies are urgently needed, both in terms of exploring patients' health concerns after LT and validating the instruments.
This study is reported according to the PRISMA Statement.
识别用于测量肝移植（LT）后患者报告结局的工具，并严格评估其测量属性。
检索了五个在线数据库，以查找从创建到2024年10月的英文肝移植特异性患者报告结局测量工具（PROMs）。纳入描述PROMs开发或验证的研究。两名评审员提取并综合了有关研究和工具特征的信息。使用基于共识的健康测量工具选择标准（COSMIN）评估纳入研究的方法学质量。两名评审员独立评估纳入工具的方法学质量。
共有17项涉及14种PROMs的研究符合纳入标准并纳入本综述。纳入的PROMs评估了一系列结局，包括健康相关生活质量、治疗依从性、症状体验、社会参与、对供体的感受、满意度和信息需求。14个量表均未报告COSMIN概述的十个测量属性类别。在所有测量属性中，专家评定的内容效度（64.3%，9/14）和内部一致性（57.1%，8/14）是测量最频繁的两个属性。不到一半的研究从患者角度评估了内容效度。四项研究使用探索性因子分析评估结构效度，但没有研究进行验证性因子分析或使用项目反应理论（IRT）方法测量结构效度。
本系统综述提供了肝移植特异性PROMs的总体情况和详细分析，并强调了完善和验证工具的匮乏。迫切需要进一步研究，既要探索肝移植后患者的健康问题，也要验证相关工具。
本研究按照系统评价和Meta分析的首选报告项目（PRISMA）声明进行报告。
