Translation and Validation of the PASS Test for GERD Patients With Partial Response to PPI: PASS-HK
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|ClinicalTrials.gov Identifier: NCT02437682|
Recruitment Status : Recruiting
First Posted : May 7, 2015
Last Update Posted : September 24, 2018
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.
|Condition or disease|
|Gastro-esophageal Reflux Disease|
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-HK, and (2) to assess the psychometric properties of the PASS-HK, 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-HK), the reliability of PASS-HK 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-HK 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-HK twice within 14 days under a stable condition. In addition to PASS-HK, all patients will have to complete SF-12v2, GERD-QOL, GERDQ and GERDSQ questionnaires.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|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-HK|
|Actual Study Start Date :||January 11, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
- PASS_C questionnaire [ Time Frame: One year ]the reliability of PASS-HK will be evaluated for internal consistency using Cronbach's alpha. The intraclass correlation coefficient will be calculated within 14 days for two surveys in order to evaluate the reproducibility of the results under constant conditions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437682
|Contact: Justin C.Y. Wu, MBChB(CUHK)||(852)2632 firstname.lastname@example.org|
|Contact: Pui Kuan Cheong, MSc||(852)2632 email@example.com|
|Prince of Wales Hospital||Recruiting|
|Hong Kong, Hong Kong|
|Contact: Justin CY Wu, MBChB(CUHK) (852)26323476 firstname.lastname@example.org|
|Contact: Pui Kuan PK Cheong, MPH (852)26323476 email@example.com|
|Principal Investigator: Justin CY Wu, MBChB(CUHK)|
|Principal Investigator:||Justin C.Y. Wu, MBChB(CUHK)||Chinese University of Hong Kong|