Translation and Validation of the PASS Test for GERD Patients With Partial Response to PPI in Chinese Population: PASS-C
The PASS test is only available and valid tool for the evaluation of persistent acid-related symptoms in patients receiving PPI therapy. There is lack of a validated Chines version of PASS questionnaire for the GERD patients with partial response to proton pump inhibitor (PPI). The English version of PASS test will be translated to traditional Chinese by using forward-backward procedure, and the Chinese version of PASS test will be validated its psychometric properties in Hong Kong population.
Eligible subjects will be invited to administer questionnaires to evaluate the psychometric properties of the Chinese version of PASS test.
Gastro-esophageal Reflux Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Translation and Validation of the PASS Test for Gastro-esophageal Reflux Disease (GERD) Patients With Partial Response to PPI in Chinese Population: PASS-C|
- PASS_C questionnaire [ Time Frame: One year ] [ Designated as safety issue: No ]
|Study Start Date:||July 2015|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Gastro-esophageal reflux disease (GERD) is a common condition defined as symptoms or mucosal damage produced by the abnormal reflux of gastric contents into the esophagus. Symptoms highly specific for GERD are heartburn, regurgitation, or both, which often occur after meals. The prevalence of GERD is around 20% for weekly reflux symptoms in the Western population, while 9.3% in Chinese population. However, approximately 20-30% of patients with GERD experience only a partial response of their heartburn of regurgitation symptoms to PPI therapy.
There is lack of a validated Chines version of PASS questionnaire for the GERD patients with partial response to PPI.
Before a treatment response assessment tool can be used clinically, various questions on reliability and validity of the instrument need to be addressed. The aims of this study are (1) to translate the PASS test from English to traditional Chinese, named PASS-C, and (2) to assess the psychometric properties of the PASS-C, before clinical application.
Linguistic translation of the PASS questionnaire from English to Chinese version will follow a forward-backward procedure.
After finalization of Chinese version of the PASS (PASS-C), the reliability of PASS-C will be evaluated for internal consistency using Cronbach's alpha. The intraclass correlation coefficient was calculated within 14 days for two surveys in order to evaluate the reproducibility of the results under constant conditions. Pearson product moment correlation coefficient will be used to evaluate whether PASS-C can measure what it claims to measure by comparing with SF-12v2, GERD QOL and GREDSQ scores.
All eligible subjects will be invited to complete PASS-C twice within 14 days under a stable condition. In addition to PASS-C, all patients will have to complete SF-12v2, GERD-QOL, GERDQ and GERDSQ questionnaires.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02437682
|Contact: Justin C.Y. Wu, MBChB(CUHK)||(852)2632 firstname.lastname@example.org|
|Contact: Pui Kuan Cheong, MSc||(852)2632 email@example.com|
|Principal Investigator:||Justin C.Y. Wu, MBChB(CUHK)||Chinese University of Hong Kong|