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甲状腺特异性生活质量患者报告结局量表ThyPRO的跨文化效度

Cross-cultural validity of the thyroid-specific quality-of-life patient-reported outcome measure, ThyPRO.

作者信息

Watt Torquil, Barbesino Giuseppe, Bjorner Jakob Bue, Bonnema Steen Joop, Bukvic Branka, Drummond Russell, Groenvold Mogens, Hegedüs Laszlo, Kantzer Valeska, Lasch Kathryn E, Marcocci Claudio, Mishra Anjali, Netea-Maier Romana, Ekker Merel, Paunovic Ivan, Quinn Terence J, Rasmussen Åse Krogh, Russell Audrey, Sabaretnam Mayilvaganan, Smit Johannes, Törring Ove, Zivaljevic Vladan, Feldt-Rasmussen Ulla

机构信息

Department of Endocrinology, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen Ø, Denmark,

出版信息

Qual Life Res. 2015 Mar;24(3):769-80. doi: 10.1007/s11136-014-0798-1. Epub 2014 Sep 7.

Abstract

BACKGROUND AND PURPOSE

Thyroid diseases are common and often affect quality of life (QoL). No cross-culturally validated patient-reported outcome measuring thyroid-related QoL is available. The purpose of the present study was to test the cross-cultural validity of the newly developed thyroid-related patient-reported outcome ThyPRO, using tests for differential item functioning (DIF) according to language version.

METHODS

The ThyPRO consists of 85 items summarized in 13 multi-item scales and one single item. Scales cover physical and mental symptoms, well-being and function as well as social and daily function and cosmetic concerns. Translation applied standard forward-backward methodology with subsequent cognitive interviews and reviews. Responses (N = 1,810) to the ThyPRO were collected in seven countries: UK (n = 166), The Netherlands (n = 147), Serbia (n = 150), Italy (n = 110), India (n = 148), Denmark (n = 902) and Sweden (n = 187). Translated versions were compared pairwise to the English version by examining uniform and nonuniform DIF, i.e., whether patients from different countries respond differently to a particular item, although they have identical level of the concept measured by the item. Analyses were controlled for thyroid diagnosis. DIF was investigated by ordinal logistic regression, testing for both statistical significance and magnitude (ΔR (2) > 0.02). Scale level was estimated by the sum score, after purification.

RESULTS

For twelve of the 84 tested items, DIF was identified in more than one language. Eight of these were small, but four were indicative of possible low translatability. Twenty-one instances of DIF in single languages were identified, indicating potential problems with the particular translation. However, only seven were of a magnitude which could affect scale scores, most of which could be explained by sample differences not controlled for.

CONCLUSION

The ThyPRO has good cross-cultural validity with only minor cross-cultural invariance and is recommended for use in international multicenter studies.

摘要

背景与目的

甲状腺疾病很常见,且常常影响生活质量(QoL)。目前尚无经过跨文化验证的、患者报告的衡量甲状腺相关生活质量的结果指标。本研究的目的是根据语言版本,通过差异项目功能(DIF)测试,来检验新开发的甲状腺相关患者报告结果指标ThyPRO的跨文化效度。

方法

ThyPRO由85个条目组成,归纳为13个多条目量表和1个单一条目。量表涵盖身体和精神症状、幸福感与功能以及社会和日常功能与外貌问题。翻译采用标准的前后翻译方法,随后进行认知访谈和审核。在七个国家收集了对ThyPRO的回答(N = 1,810):英国(n = 166)、荷兰(n = 147)、塞尔维亚(n = 150)、意大利(n = 110)、印度(n = 148)、丹麦(n = 902)和瑞典(n = 187)。通过检查一致性和非一致性DIF,即将翻译版本与英语版本进行两两比较,也就是检查来自不同国家的患者对某个特定条目回答是否不同,尽管他们在所测条目的概念水平相同。分析时对甲状腺诊断进行了控制。通过有序逻辑回归研究DIF,同时检验统计学显著性和效应大小(ΔR (2) > 0.02)。量表水平在纯化后通过总分进行估计。

结果

在84个测试条目中,有12个条目在一种以上语言中发现了DIF。其中8个差异较小,但4个表明可能存在翻译难度较大的问题。在单一语言中发现了21例DIF,表明特定翻译可能存在问题。然而,只有7例的效应大小可能会影响量表得分,其中大多数可以通过未控制的样本差异来解释。

结论

ThyPRO具有良好的跨文化效度,仅有轻微的跨文化不变性,推荐用于国际多中心研究。

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