Gastroesophageal Reflux Disease Clinical Trial
Official title:
Development of a Novel Disease-Specific Quality of Life Questionnaire for Gastroesophageal Reflux Disease (GERD) Patients in Chinese Population
A questionnaire composed of items addressing psychological, emotional and social aspects of
GERD is developed for Chinese population. We plan to conduct a validation study on this
novel disease-specific quality of life (QoL) instrument. This study aims to evaluate various
indicators of validity and reliability, which include criterion validity, test-retest
reliability, responsiveness, internal consistency reliability and discriminant validity.
After initial pilot testing of face validity and content validity, two hundred GERD patients
from the gastroenterology and ulcer clinics of cluster NTE hospitals will be invited to
complete a revised 18-item version of GERD-QOL questionnaire. The data from GERD QOL will be
evaluated using exploratory factor analysis to identify appropriate items and domains and
the internal consistency of the domains will be determined and further refinement of
questionnaire will follow.
100 GERD patients will complete GERD-QOL, SF-36 health survey and the visual analog scale
(VAS) questionnaire for criterion validation. 100 GERD patients with stable symptom profile
will repeat GERD QOL two weeks after the first administration for evaluation of test-retest
reliability.
Another 26 patients who are receiving maintenance acid suppressive therapy and in remission
of symptom will be recruited as controls for comparison with active reflux patients. The
ability to distinguish active patients from controls in remission is known as discriminant
validity.
n/a
Observational Model: Cohort, Time Perspective: Cross-Sectional
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