Pereira Giedre Ingrid das Neves, Costa Carlos Dario da Silva, Geocze Luciana, Borim Aldenis Albaneze, Ciconelli Rozana Mesquita, Camacho-Lobato Luciana
Federal University of São Paulo, São Paulo, SP.
Arq Gastroenterol. 2007 Apr-Jun;44(2):168-77. doi: 10.1590/s0004-28032007000200016.
Gastroesophageal reflux disease has been shown patients to alter quality of life and working productivity. Most of the instruments available for this type of assessment come from English or French speaking countries. To use these instruments in Brazil requires a judicious process of translation and validation.
Translating to Portuguese the questionnaires GSAS (Gastroesophageal Reflux Disease Symptom Assessment Scale), GERD-HRQL (Gastroesophageal Reflux Disease - Health Related Quality of Life) and HBQOL (Heartburn Specific Quality of Life Instrument) specific for quality of life assessment in gastroesophageal reflux disease. Testing the psychometric properties of reliability and validity of the referred disease specific instruments.
One hundred and thirty two gastroesophageal reflux disease patients (mean age 54.9 years and +/- SD 13.9) from the Digestive Disease Motility Outpatient Clinic, Federal University of São Paulo, SP, Brazil and the Department of Surgical Gastroenterology "São José do Rio Preto" School of Medicine, São José do Rio Preto, SP, Brazil, accepted to participate and signed the informed consent form. Forty of these patients took part in the pre-test phase (28 females and 12 males, mean age 55.3 years +/- SD 14.7) and the remaining 92 part in the validation phase (64 females and 28 males, mean age 54.7 years and +/- SD 13.7). The translation and cultural adaptation processes were carried out accordingly us to the method of Guillemin et al (1993). The validation processes of the disease specific translated questionnaires (GSAS, GERD-HRQL and HBQOL) was performed in relation to a generic (SF-36) and a symptomatic (SQGERD) instrument.
Nine words of the GSAS, four of the GERD-HRQL and six of the HBQOL were replaced during the cultural adaptation phase. The GSAS questionnaire was discontinued after this phase because of scoring problems. Therefore reliability and validity were tested only for the two remaining questionnaires. These questionnaires proved to be reproducible for both inter and intra-observer relationships (0.980 and 0.968 values for the GERD-HRQL and varying values of 0.868 to 0.972 for the HBQOL). The HBQOL questionnaire demonstrated high internal consistency (>0.70) for three of the four dimensions tested (physical aspect, pain, sleep). Good correlations levels with the SF-36 and SQGERD questionnaires were demonstrated during the validation phase.
The cross cultural adaptation of the Portuguese (Brazil) versions of the GERD-HRQL and HBQOL instruments proved to be reliable and valid options with low burden level for assessment of quality of life in gastroesophageal reflux disease our country. The HBQOL is the only multidimensional questionnaire for quality of life assessment in gastroesophageal reflux disease currently available in Brazil. The Portuguese (Brazil) version of the GSAS instrument proved inadequate for quality of life assessment in our country.
胃食管反流病已被证实会改变患者的生活质量和工作效率。大多数可用于此类评估的工具都来自英语或法语国家。要在巴西使用这些工具,需要经过审慎的翻译和验证过程。
将用于胃食管反流病生活质量评估的GSAS(胃食管反流病症状评估量表)、GERD-HRQL(胃食管反流病-健康相关生活质量)和HBQOL(烧心特异性生活质量工具)问卷翻译成葡萄牙语。测试上述特定疾病工具的信度和效度等心理测量特性。
来自巴西圣保罗联邦大学消化疾病运动门诊和巴西圣保罗里奧普雷图医学院外科胃肠病学系的132例胃食管反流病患者(平均年龄54.9岁,标准差±13.9)同意参与并签署了知情同意书。其中40例患者参与了预测试阶段(28例女性和12例男性,平均年龄55.3岁,标准差±14.7),其余92例参与了验证阶段(64例女性和28例男性,平均年龄54.7岁,标准差±13.7)。翻译和文化调适过程按照Guillemin等人(1993年)的方法进行。针对通用型(SF-36)和症状型(SQGERD)工具,对特定疾病的翻译问卷(GSAS、GERD-HRQL和HBQOL)进行了验证过程。
在文化调适阶段,GSAS问卷中有9个词、GERD-HRQL问卷中有4个词、HBQOL问卷中有6个词被替换。由于评分问题,GSAS问卷在此阶段后停用。因此,仅对其余两份问卷进行了信度和效度测试。这些问卷在观察者间和观察者内关系中均被证明具有可重复性(GERD-HRQL的数值为0.980和0.968,HBQOL的数值在0.868至0.972之间变化)。HBQOL问卷在所测试的四个维度中的三个维度(身体方面、疼痛、睡眠)显示出较高的内部一致性(>0.70)。在验证阶段,与SF-36和SQGERD问卷显示出良好的相关性水平。
GERD-HRQL和HBQOL工具的葡萄牙语(巴西)版本的跨文化调适被证明是可靠且有效的选择,在我国评估胃食管反流病生活质量时负担水平较低。HBQOL是巴西目前唯一可用于胃食管反流病生活质量评估的多维问卷。GSAS工具的葡萄牙语(巴西)版本在我国被证明不适用于生活质量评估。