Gastroesophageal Reflux Disease and Esophageal Motility Disorders Clinical Trial
Official title:
Quality of Life Among Patients With Chronic Esophageal Disorders : Spanish Translation and Validation of the Survey "Northwestern Esophageal Quality of Life Scale" in Hispanics
Chronic esophageal disorders affect approximately one third part of global population, with a deleterious impact in the quality of life of patients. Measured of health related quality of life in chronic esophageal conditions such as gastroesophageal reflux disease and achalasia are widely used to measure this important patient-reported outcome. The Northwestern Esophageal Quality of Life (NEQOL) is a hybrid measure of esophageal illness, allowing for broad use across esophageal diseases while maintain sensitivity to nuances of a specific condition. The NEQOL is a reliable and valid hybrid measure of disease specific health related quality of life across several chronic esophageal conditions. The Ecuadorian Institute of Digestive Diseases aims to translate and validate this survey into Spanish for its use in a Hispanic population. This cross-sectional study aims to translate, apply and validate the NEQOL in the patients attending in the esophageal division of the institute.
Methods: An authorization for translating the survey into Spanish was obtained from the
survey authors. The translation and cross-cultural adaptations were carried out based on
guidelines and international criteria proposed by Sperber. The NEQOL was translated
independently from English into Spanish by two professional translators. Each one provided a
written report, which was combined by the authors in a new version that contained the most
reliable translation for each question. The new version was back translated to English by two
different professional translators, who were blinded to the original version of the NEQOL. A
new English version was developed by combining the written reports. The aim of the back
translation was to compare each item of the new English version with the original NEQOL. Each
item of the new English version was compared with the original questionnaire by 30 native
English speakers. The success of the translation was evaluated using two scales of
comparison: comparability of language and similarity of interpretability. Each one used
Likert scales ranging from 1 (extremely comparable/ extremely similar) to 7 (not at all
comparable/ not at all similar). A mean score for each question was obtained. Questions with
mean scores of three or less were included in the Spanish version. The Spanish version of the
NEQOL was tested on 10 subjects diagnosed with GERD, each subject provided feedback on the
survey content, which was used to make final corrections. The questionnaire contains fourteen
questions; every statement refers to the impact of the esophageal condition in the quality of
life. There are five options ranking from not at all true to very true, with every option
meaning a numerical value, a higher grade in the questionnaire will express a better quality
of life and a low impact in the health-related quality of life.
Patients above 18 years old with chronic esophageal disorders, that require a functional
esophageal test such as ph-impedanciometry and/or high-resolution manometry, will be
included. Written informed consent will be obtained. All participants will complete the
questionnaire before performing the functional esophageal tests and a gastroenterologist
specialized on functional esophageal pathology will perform the esophageal tests and analyze
the results. Finally, the data from the questionnaire will be compared with the esophageal
tests results in order to stablish if there is a correlation between the impact in the
quality of life measured by the questionnaire and the tests results.
Statistical analysis: Base line characteristics will be analyzed using Chi-square o Fisher
Test for categorical variable, and the Mann-Whitney Test for continuing variables. Continuous
variables will be expressed as mean +/- standard deviation. The sensitivity, specificity,
predictive values and accuracy will be calculated with the 95% Confidence Interval (95% CI).
A P value of less than 0.05 was considered to be statistically significant. All the
statistical analysis was performed using SPSS software suite v.22.
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