Thomas Melanie, Gabe-Walters Marie, Humphreys Ioan, Watkins Alan
Lymphoedema Wales Clinical Network, Swansea Bay University Health Board, Wales, United Kingdom.
Faculty of Medicine, Health and Life Sciences, Swansea University, Wales, United Kingdom.
PLoS One. 2025 May 23;20(5):e0315314. doi: 10.1371/journal.pone.0315314. eCollection 2025.
A new lymphoedema-specific Patient Reported Outcome Measure (LYMPROM©) was developed to help patients easily report the impact of their lymphoedema and enable lymphoedema therapists to understand what matters most to patients.
This paper describes the validation of LYMPROM© for adults with lymphoedema.
A multi-phased iterative review was undertaken to investigate the reliability and validity of LYMPROM©. Face and content validity were reviewed by surveying patient representatives and healthcare professionals, along with the validity of LYMPROM© Cymraeg, a Welsh translation. Following COSMIN guidelines, validation study phases used anonymised routinely collected data to examine internal consistency, structural validity, construct validity (compared with the EQ5D-5L), measurement error, test-retest reliability and responsiveness.
LYMPROM© demonstrated validity (content and construct) and reliability (test-retest, internal consistency). All items were regarded as relevant, comprehensive and clear, with item content validity index (CVI) between 0.83 to 1.00, and average overall assessment of 0.94. Robust development of LYMPROM© Cymraeg ensured appropriate translation into Welsh. LYMPROM© item scores, with means and medians generally in the lower half of the scale, were positively correlated, as were three (Physical health, Social health and Emotional health) domain scores (domain correlations: 0.595 to 0.812). LYMPROM© total and domain scores showed moderate negative correlations (-0.577 to -0.435) with EQ5D-5L measures. LYMPROM© total and domain scores showed good test-retest (within two weeks) properties, with little or no change in mean or median scores, and strong positive correlations between test and retest scores (Total: 0.919; Physical health domain: 0.922; Social health domain: 0.889; Emotional health domain: 0.820). LYMPROM© showed good responsiveness, with strong, positive correlations between total and domain initial and repeat (between four weeks and seven months later) scores, with a slight reduction in scores (-3.8 to -2.0 units) and some indication of relationships between reduction and time interval (Total: p = 0.025; Physical health domain: 0.034; Social health domain: 0.181; Emotional health domain: 0.009).
Evidence shows that LYMPROM© offers a reliable and valid tool for use in clinical practice. Scores on three domains allow a more granular assessment of the patient's view of their condition; these scores and the total LYMPROM© score exhibit moderate correlations with more generic EQ5D-5L measures. Further research will explore relationships between patient-level characteristics and LYMPROM© responses, and extend initial work on its cross-cultural validity.
一种新的针对淋巴水肿的患者报告结局量表（LYMPROM©）被开发出来，以帮助患者轻松报告淋巴水肿对其的影响，并使淋巴水肿治疗师能够了解对患者最重要的事情。
本文描述了LYMPROM©在成年淋巴水肿患者中的验证情况。
进行了多阶段迭代审查，以研究LYMPROM©的可靠性和有效性。通过对患者代表和医疗保健专业人员进行调查来审查表面效度和内容效度，以及威尔士语翻译版LYMPROM© Cymraeg的效度。遵循COSMIN指南，验证研究阶段使用匿名的常规收集数据来检查内部一致性、结构效度、构想效度（与EQ5D - 5L相比）、测量误差、重测信度和反应度。
LYMPROM©显示出效度（内容和构想）和信度（重测、内部一致性）。所有项目都被认为是相关、全面且清晰的，项目内容效度指数（CVI）在0.83至1.00之间，总体平均评分为0.94。LYMPROM© Cymraeg的稳健开发确保了其被适当地翻译成威尔士语。LYMPROM©项目得分的均值和中位数通常处于量表的下半部分，呈正相关，三个领域得分（身体健康、社会健康和情绪健康）也是如此（领域相关性：0.595至0.812）。LYMPROM©总分和领域得分与EQ5D - 5L测量值呈中度负相关（-0.577至-0.435）。LYMPROM©总分和领域得分显示出良好的重测（两周内）特性，均值或中位数得分几乎没有变化，测试和重测得分之间呈强正相关（总分：0.919；身体健康领域：0.922；社会健康领域：0.889；情绪健康领域：0.820）。LYMPROM©显示出良好的反应度，总分和领域初始得分与重复得分（四周至七个月后）之间呈强正相关，得分略有下降（-3.8至-2.0分），并且有一些迹象表明得分下降与时间间隔之间存在关系（总分：p = 0.025；身体健康领域：0.034；社会健康领域：0.181；情绪健康领域：0.009）。
证据表明，LYMPROM©为临床实践提供了一种可靠且有效的工具。三个领域的得分允许对患者对其病情的看法进行更细致的评估；这些得分和LYMPROM©总分与更通用的EQ5D - 5L测量值呈中度相关。进一步的研究将探索患者层面特征与LYMPROM©反应之间的关系，并扩展其跨文化效度的初步工作。
