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一种用于测量银屑病关节炎患者健康相关生活质量的新工具的开发与验证:VITACORA-19。

Development and validation of a new instrument to measure health-related quality of life in patients with psoriatic arthritis: the VITACORA-19.

作者信息

Torre-Alonso Juan Carlos, Gratacós Jordi, Rey-Rey José Santos, Valdazo de Diego Juan Pablo, Urriticoechea-Arana Ana, Daudén Esteban, Moreno Mireia, Zarco-Montejo Pedro, Collantes-Estévez Eduardo, Fernández-López Juan Antonio

机构信息

From the Facultad de Medicina; Hospital Monte Naranco, Oviedo; Hospital Parc Tauli, Sabadell; Complejo Hospitalario Toledo, Toledo; Hospital Virgen de la Concha, Zamora; Hospital Can Mises, Ibiza; Hospital Universitario de la Princesa; Hospital Alcorcon, Madrid; University Hospital "Reina Sofía"/IMIBIC, Cordoba; Centro Salud Riosa, Astorias, Spain.J.C. Torre-Alonso, MD, PhD, Facultad de Medicina, Hospital Monte Naranco; J. Gratacós, MD, PhD; M. Moreno, MD, Hospital Parc Tauli; J.S. Rey-Rey, MD, Complejo Hospitalario Toledo; J.P. Valdazo de Diego, MD, Hospital Virgen de la Concha; A. Urriticoechea-Arana, MD, Hospital Can Mises; E. Daudén, MD, PhD, Hospital Universitario de la Princesa; P. Zarco-Montejo, MD, PhD, Hospital Alcorcon; E. Collantes-Estévez, MD, PhD, University Hospital "Reina Sofía"/IMIBIC, Cordoba; J.A. Fernández-López, MD, PhD, Centro Salud Riosa.

出版信息

J Rheumatol. 2014 Oct;41(10):2008-17. doi: 10.3899/jrheum.131021. Epub 2014 Sep 1.

DOI:10.3899/jrheum.131021
PMID:25179846
Abstract

OBJECTIVE

To develop/validate an instrument to measure health-related quality of life (HRQoL) in patients with psoriatic arthritis (PsA), for use in clinical studies.

METHODS

An item pool of 35 items was generated following standardized procedures. Item reduction was performed using clinimetric and psychometric approaches after administration to 66 patients with PsA. The resulting instrument, the VITACORA-19, consists of 19 items. Its validity content, internal consistency, test-retest reliability, known groups/convergent validity, and sensitivity to change were tested in a longitudinal and multicenter study conducted in 10 hospitals in Spain, with 323 patients who also completed the EuroQol 5-dimensional questionnaire (EQ-5D) and a health status transition item. There were 3 study groups: group A (n = 209, patients with PsA), group B (n = 71, patients with arthritis without psoriatic aspect, patients with arthrosis, and patients with dermatitis), and group C (n = 43, healthy controls).

RESULTS

The questionnaire was considered easy/very easy to answer by 94.7% of the patients with PsA. The factorial analysis clearly identified only 1 factor. Cronbach's alpha coefficient and interclass correlation coefficients exceeded 0.90. Statistically significant differences (p < 0.001) were observed between groups: subjects from group C had better HRQoL, followed by group B, and finally group A had the worst HRQoL. The VITACORA-19 scores showed significant correlations (p < 0.001) to PsA disease activity, EQ-5D, and perceived health state, scoring the patients with better health state higher. The minimum important difference was established as an 8-point change in the global score.

CONCLUSION

The Spanish-developed VITACORA-19, designed to measure HRQoL in patients with PsA, has good validity, reliability, and sensitivity to change.

摘要

目的

开发/验证一种用于测量银屑病关节炎(PsA)患者健康相关生活质量(HRQoL)的工具,以供临床研究使用。

方法

按照标准化程序生成了一个包含35个条目的条目池。在对66例PsA患者进行施测后,采用临床计量学和心理测量学方法进行条目缩减。最终形成的工具VITACORA - 19由19个条目组成。在西班牙10家医院开展的一项纵向多中心研究中,对323例患者进行了测试,这些患者还完成了欧洲五维健康量表(EQ - 5D)和一项健康状况转变条目,以检验其效度内容、内部一致性、重测信度、已知组/收敛效度以及对变化的敏感性。研究分为3组:A组(n = 209,PsA患者)、B组(n = 71,无银屑病表现的关节炎患者、骨关节炎患者和皮炎患者)和C组(n = 43,健康对照)。

结果

94.7%的PsA患者认为该问卷易于/非常易于回答。因子分析明确仅识别出1个因子。Cronbach's α系数和组内相关系数均超过0.90。组间观察到具有统计学意义的差异(p < 0.001):C组受试者的HRQoL最佳,其次是B组,A组的HRQoL最差。VITACORA - 量表得分与PsA疾病活动度、EQ - 5D以及感知健康状态显著相关(p < 0.001),健康状态较好的患者得分更高。最小重要差异被确定为总体得分有8分的变化。

结论

西班牙开发的用于测量PsA患者HRQoL的VITACORA - 19具有良好的效度、信度和对变化的敏感性。

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