Department of Ophthalmology, School of Medicine, University of São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255 - São Paulo - SP, 05403-000, Brazil.
Department of Radiology, School of Medicine, University of São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255 - São Paulo - SP, 05403-000, Brazil.
J Clin Epidemiol. 2015 Apr;68(4):370-8. doi: 10.1016/j.jclinepi.2014.07.009. Epub 2014 Dec 17.
To provide a reliable, validated, and culturally adapted instrument that may be used in monitoring dry eye in Brazilian patients and to discuss the strategies for the enhancement of the cross-cultural adaptation and validation process of a self-report measure for dry eye.
The cross-cultural adaptation process (CCAP) of the original Ocular Surface Disease Index (OSDI) into Brazilian-Portuguese was conducted using a 9-step guideline. The synthesis of translations was tested twice, for face and content validity, by different subjects (focus groups and cognitive interviews). The expert committee contributed on several steps, and back translations were based on the final rather than the prefinal version. For validation, the adapted version was applied in a prospective longitudinal study to 101 patients from the Dry Eye Clinic at the General Hospital of the University of São Paulo, Brazil. Simultaneously to the OSDI, patients answered the short form-36 health survey (SF-36) and the 25-item visual function questionnaire (VFQ-25) and underwent clinical evaluation. Internal consistency, test-retest reliability, and measure validity were assessed.
Cronbach's alpha value of the cross-culturally adapted Brazilian-Portuguese version of the OSDI was 0.905, and the intraclass correlation coefficient was 0.801. There was a statistically significant difference between OSDI scores in patients with dry eye (41.15 ± 27.40) and without dry eye (17.88 ± 17.09). There was a negative association between OSDI and VFQ-25 total score (P < 0.01) and between the OSDI and five SF-36 domains. OSDI scores correlated positively with lissamine green and fluorescein staining scores (P < 0.001) and negatively with Schirmer test I and tear break-up time values (P < 0.001).
Although most of the reviewed guidelines on CCAP involve well-defined steps (translation, synthesis/reconciliation, back translation, expert committee review, pretesting), the proposed methodological steps have not been applied in a uniform way. The translation and adaptation process requires skill, knowledge, experience, and a considerable investment of time to maximize the attainment of semantic, idiomatic, experiential, and conceptual equivalence between the source and target questionnaires. A well-established guideline resulted in a culturally adapted Brazilian-Portuguese version of the OSDI, tested and validated on a sample of Brazilian population, and proved to be a valid and reliable instrument for assessing patients with dry eye syndrome in Brazil.
提供一种可靠、有效的、经文化调适的工具，可用于监测巴西患者的干眼症，并讨论增强干眼症自评量表跨文化调适和验证过程的策略。
采用 9 步指南对原始眼表疾病指数（OSDI）进行巴西葡萄牙语的跨文化调适。翻译的综合测试进行了两次，由不同的主体（焦点小组和认知访谈）进行了两次，以评估表面和内容效度。专家委员会在几个步骤上做出了贡献，并且基于最终版本而非预最终版本进行回译。为了进行验证，将调适后的版本应用于巴西圣保罗大学总医院干眼症诊所的 101 例患者的前瞻性纵向研究。同时，患者使用 OSDI 回答简短 36 健康调查（SF-36）和 25 项视觉功能问卷（VFQ-25），并进行临床评估。评估内部一致性、重测信度和测量有效性。
经文化调适的巴西葡萄牙语版 OSDI 的克朗巴赫 α 值为 0.905，组内相关系数为 0.801。干眼症患者（41.15±27.40）和无干眼症患者（17.88±17.09）的 OSDI 评分存在统计学差异。OSDI 评分与 VFQ-25 总分呈负相关（P＜0.01），与五个 SF-36 域呈负相关。OSDI 评分与丽丝胺绿和荧光素染色评分呈正相关（P＜0.001），与泪液分泌试验 I 和泪膜破裂时间值呈负相关（P＜0.001）。
尽管大多数关于 CCAP 的审查指南都涉及定义明确的步骤（翻译、综合/协调、回译、专家委员会审查、预测试），但所提出的方法步骤并未以统一的方式应用。翻译和调适过程需要技能、知识、经验和大量时间投入，以最大限度地实现源问卷和目标问卷之间的语义、惯用语、经验和概念等效。在巴西人群中对 OSDI 进行了测试和验证的、经过良好确立的指南产生了一种经文化调适的巴西葡萄牙语版 OSDI，被证明是评估巴西干眼症综合征患者的有效和可靠工具。
