血液系统恶性肿瘤患者报告结局量表（HM-PRO）丹麦语版本的翻译、文化调适及验证
Translation, cultural adaptation and validation of the Danish version of the haematological malignancy patient-reported outcome measure (HM-PRO).
作者信息
Salek Sam, Möller Sören, Abildgaard Niels, Rosenberg Tine, Larsen Maria Torp, Asdahl Peter, Pedersen Kasper Kofod, Lassen Marie Therese, Andersen Christen Lykkegaard, Nielsen Lene Kongsgaard
机构信息
School of Life and Medical Sciences, University of Hertfordshire, College Lane, Hatfield, SL9 8BL, UK.
Open Patient Data Explorative Network (OPEN), Odense University Hospital, Odense, Denmark.
出版信息
J Patient Rep Outcomes. 2025 Apr 29;9(1):43. doi: 10.1186/s41687-025-00869-2.
BACKGROUND
Assessment of cancer patients´ quality of life (QoL) through patient-reported outcomes (PRO) during and after treatment is gaining ground. The HM-PRO is the first generic Haematological Malignancy specific PRO measure for use in clinical practice and clinical trials. Such generic tools are needed in Denmark. The study aim was to translate and cross-culturally adapt the HM-PRO into Danish and evaluate the psychometric properties.
METHODS
Translation and cross-cultural adaptation of the original English HM-PRO into Danish followed established guidelines. After cognitive debriefing interviews, it underwent psychometric testing with a variety of hematologic malignancies. Construct validity, internal consistency, dimensionality, item response theory (IRT) and differential item functioning were investigated.
RESULTS
295 patients were included for psychometric evaluation; confirmatory factor and bifactor analyses for both HM-PRO parts provided good evidence to support the suggested factor structure (Cronbach's-α Part-A = 0.81, Part-B = 0.84; Part-A CFA CFI = 0.922, TLI = 0.912; bi-factor CFI = 0.989, TLI = 0.978). IRT showed good item-fit and factor loadings and absence of local dependency.
CONCLUSION
The HM-PRO has demonstrated favourable psychometric properties and can be used broadly within the Danish Healthcare system to monitor symptoms as well as QoL impact of patients with haematological cancer and optimize patient engagement during routine cancer care. WHAT IS THE NEW ASPECT OF YOUR WORK?: In response to the intention of the Danish Health Authority to systematically collect PRO data on health-related QoL in Danish cancer patients, this study investigates the translation and cross-cultural adaptation of the original English HM-PRO into Danish. WHAT IS THE CENTRAL FINDING OF YOUR WORK?: Few issues were met with the translation and adaptation of HM-PRO into Danish. WHAT IS (OR COULD BE) THE SPECIFIC CLINICAL RELEVANCE OF YOUR WORK?: The HM-PRO has demonstrated favourable psychometric properties and can be used broadly within the Danish Healthcare system to monitor symptoms as well as QoL impact of patients with haematological cancer and optimize patient engagement during routine cancer care.
背景
通过患者报告结局（PRO）评估癌症患者治疗期间及之后的生活质量（QoL）正逐渐得到认可。HM-PRO是首个用于临床实践和临床试验的血液系统恶性肿瘤特异性通用PRO测量工具。丹麦需要此类通用工具。本研究旨在将HM-PRO翻译成丹麦语并进行跨文化调适，同时评估其心理测量特性。
方法
按照既定指南将原始英文HM-PRO翻译成丹麦语并进行跨文化调适。经过认知性预试验访谈后，对多种血液系统恶性肿瘤患者进行心理测量测试。研究了结构效度、内部一致性、维度、项目反应理论（IRT）及项目功能差异。
结果
纳入295例患者进行心理测量评估；对HM-PRO两个部分进行的验证性因素分析和双因素分析均提供了充分证据支持所建议的因素结构（克朗巴哈α系数：A部分=0.81，B部分=0.84；A部分验证性因素分析的比较拟合指数（CFI）=0.922，塔克-刘易斯指数（TLI）=0.912；双因素CFI=0.989，TLI=0.978）。IRT显示项目拟合良好、因素负荷良好且无局部依赖性。
结论
HM-PRO已证明具有良好的心理测量特性，可在丹麦医疗保健系统中广泛用于监测血液系统癌症患者的症状以及生活质量影响，并在常规癌症护理期间优化患者参与度。你的工作有哪些新方面？：为响应丹麦卫生当局系统收集丹麦癌症患者健康相关生活质量PRO数据的意图，本研究调查了将原始英文HM-PRO翻译成丹麦语并进行跨文化调适的情况。你的工作的核心发现是什么？：将HM-PRO翻译成丹麦语并进行调适遇到的问题很少。你的工作（或可能）具有哪些具体的临床意义？：HM-PRO已证明具有良好的心理测量特性，可在丹麦医疗保健系统中广泛用于监测血液系统癌症患者的症状以及生活质量影响，并在常规癌症护理期间优化患者参与度。
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