Ionova T I, Nikitina T P, Mayevskaya E A, Cheremushkina N V, Shaburov R I, Kucheryavyy Y A, Maev I V
Multinationalnational Center for Quality of Life Research.
Saint Petersburg State University Hospital.
Ter Arkh. 2020 Sep 3;92(8):12-17. doi: 10.26442/00403660.2020.08.000658.
Gastroesophageal reflux disease (GERD) is a common chronic disease of the upper gastrointestinal tract with long course of the disease and followed by different symptoms significantly reducing quality of life (QoL) in pts. Assessment of QoL in pts with GERD may be of value for comprehensive evaluation of treatment effect as well as for monitoring of pts during treatment course in a real clinical practice.
Development of the Russian version of GERD-HRQL questionnaire to assess symptomatic outcomes of GERD in research and real clinical practice.
GERD-HRQL questionnaire (V. Velanovich, USA) consists of 11 items: 10 items for assessment of the most frequent symptoms/problems related with QoL in pts with GERD and 1 item for assessment of patient-reported global satisfaction with health condition.
In accordance with international guidelines, the new language version of the tool may be used in research and clinical practice after cross cultural adaptation, linguistic validation and psychometric testing. This paper presents the results of cross-cultural adaptation and linguistic validation of the Russian version of GERD-HRQL. The following steps of linguistic and cultural adaptation of GERD-HRQL for Russia were conducted after the permission from the author of GERD-HRQL was obtained: forward translation with creation of two forward translations of GERD-HRQL in Russian, reconciliation and expert evaluation of translations of GERD-HRQL in Russian and creation of the preliminary version of GERD-HRQL in Russian, back translation, harmonization, creation of the first test-version of GERD-HRQL in Russian, cognitive debriefing and decentering, creation of the second test-version of GERD-HRQL in Russian, final expert evaluation and development of the final test-version of GERD-HRQL in Russian. Satisfactory face validity of the Russian test-version of GERD-HRQL was shown: face validity indices were 0.98, 0.95, 0.92, and 0.97.
As the result of translation, cross cultural adaptation and linguistic validation, the Russian version of GERD-HRQL for the use in pts with GERD in Russia was developed. The Russian version of GERD-HRQL may be used in research studies and clinical practice after testing its psychometric properties.
胃食管反流病（GERD）是上消化道常见的慢性疾病，病程长，会出现不同症状，显著降低患者的生活质量（QoL）。在实际临床实践中，评估GERD患者的生活质量对于全面评估治疗效果以及在治疗过程中监测患者可能具有重要价值。
开发俄罗斯版GERD-HRQL问卷，以评估GERD在研究和实际临床实践中的症状性结局。
GERD-HRQL问卷（美国的V. Velanovich）由11个项目组成：10个项目用于评估GERD患者中与生活质量相关的最常见症状/问题，1个项目用于评估患者报告的对健康状况的总体满意度。
根据国际指南，该工具的新语言版本在经过跨文化适应、语言验证和心理测量测试后可用于研究和临床实践。本文展示了俄罗斯版GERD-HRQL的跨文化适应和语言验证结果。在获得GERD-HRQL作者的许可后，对GERD-HRQL进行了针对俄罗斯的语言和文化适应的以下步骤：正向翻译，创建GERD-HRQL的两个俄语正向翻译版本，对GERD-HRQL俄语翻译版本进行核对和专家评估，并创建GERD-HRQL俄语初步版本，反向翻译，协调，创建GERD-HRQL俄语第一个测试版本，认知反馈和去中心化，创建GERD-HRQL俄语第二个测试版本，最终专家评估并开发GERD-HRQL俄语最终测试版本。俄罗斯测试版GERD-HRQL显示出令人满意的表面效度：表面效度指数分别为0.98、0.95、0.92和0.97。
经过翻译、跨文化适应和语言验证，开发出了适用于俄罗斯GERD患者的俄罗斯版GERD-HRQL。在测试其心理测量特性后，俄罗斯版GERD-HRQL可用于研究和临床实践。
