Rimmer Ben, Jenkins Rebeka, Russell Siân, Craig Dawn, Sharp Linda, Exley Catherine
Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.
Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, United Kingdom; Statistics and Clinical Studies, NHS Blood and Transplant, Bristol, United Kingdom.
Transplant Rev (Orlando). 2024 Apr;38(2):100836. doi: 10.1016/j.trre.2024.100836. Epub 2024 Feb 13.
We aimed to identify the condition- and transplant-specific patient-reported outcome measures (PROMs) available to measure quality of life (QoL) in solid organ transplant (SOT) recipients, examine their development and content, and critically appraise the quality of their measurement properties, to inform recommendations for clinical and research use.
We systematically searched MEDLINE, Embase, CINAHL, PsycINFO, Cochrane CENTRAL, and Scopus from inception to 27th January 2023. Search hits were screened for eligibility by two independent reviewers; papers reporting the development and/or validation of condition- and transplant-specific PROMs measuring QoL in adult SOT recipients were considered eligible. We abstracted and synthesised data on PROM characteristics, development (item generation and/or reduction), and content (QoL dimensions). Quality appraisal and synthesis were informed by the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines, and included methodological and quality assessment of measurement properties, GRADE levels of evidence, feasibility and interpretability.
We identified 33 papers reporting 26 QoL PROMs validated in SOT recipients (kidney n = 10 PROMs; liver n = 6; lung n = 3; heart n = 2; pancreas n = 1; multiple organs n = 4). Patient discussions (n = 17 PROMs) and factor analysis (n = 11) were the most common item generation and reduction techniques used, respectively. All PROMs measured ≥3 of nine QoL dimensions (all measured emotional functioning); KDQoL-SF and NIDDK-QA measured all nine. Methodological quality was variable; no PROM had low evidence or better for all measurement properties. All PROMs were COSMIN recommendation category 'B', primarily because none had sufficient content validity.
There are many condition- and transplant-specific QoL PROMs validated in SOT recipients, particularly kidney. These findings can help inform PROM selection for clinicians and researchers. However, caution is required when adopting measures, due to the substantial heterogeneity in development, content, and quality. Each PROM has potential but requires further research to be recommendable. Greater consideration of patient and professional involvement in PROM development in this setting is needed to ensure sufficient content validity.
我们旨在确定可用于衡量实体器官移植（SOT）受者生活质量（QoL）的特定疾病和移植相关的患者报告结局指标（PROMs），研究其开发过程和内容，并严格评估其测量属性的质量，为临床和研究应用提供建议。
我们系统检索了从创刊至2023年1月27日的MEDLINE、Embase、CINAHL、PsycINFO、Cochrane CENTRAL和Scopus数据库。由两名独立评审员筛选检索结果以确定其是否符合纳入标准；报道在成年SOT受者中测量QoL的特定疾病和移植相关PROMs的开发和/或验证的论文被视为符合标准。我们提取并综合了有关PROM特征、开发（条目生成和/或缩减）和内容（QoL维度）的数据。质量评估和综合工作依据基于共识的健康测量工具选择标准（COSMIN）指南进行，包括测量属性的方法学和质量评估、证据的GRADE等级、可行性和可解释性。
我们确定了33篇报道在SOT受者中验证的26种QoL PROMs的论文（肾脏移植有10种PROMs；肝脏移植有6种；肺移植有3种；心脏移植有2种；胰腺移植有1种；多器官移植有4种）。患者讨论（17种PROMs）和因子分析（11种）分别是最常用的条目生成和缩减技术。所有PROMs均测量了九个QoL维度中的≥3个维度（均测量了情绪功能）；KDQoL-SF和NIDDK-QA测量了所有九个维度。方法学质量参差不齐；没有一种PROM在所有测量属性方面具有低证据等级或更优等级。所有PROMs均为COSMIN推荐类别“B”，主要原因是没有一种具有足够的内容效度。
在SOT受者中，尤其是肾脏移植受者中，有许多特定疾病和移植相关的QoL PROMs得到了验证。这些发现有助于为临床医生和研究人员选择PROMs提供参考。然而，由于开发、内容和质量存在很大异质性，在采用这些测量指标时需要谨慎。每种PROM都有潜力，但需要进一步研究才能被推荐。在这种情况下，需要更多地考虑患者和专业人员参与PROM的开发，以确保有足够的内容效度。
