Translation and Validation of the PASS Test for GERD Patients With Partial Response to PPI: PASS-HK

Gastro-esophageal Reflux Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02437682
• Other study ID #: PASS-HK
• Status: Recruiting
• Start date: January 11, 2017
• Est. completion date: December 2019

Study information

• Verified date: September 2018
• Source: Chinese University of Hong Kong
• Contact: Justin C.Y. Wu, MBChB(CUHK)
• Phone: (852)2632 3855
• Email: justinwu[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to give study informed consent

• Male or female. Age 18 or above

• Have at least 6 months history of GERD symptoms (need not to be consecutive) as chief complaint, e.g. acid regurgitation or heartburn

• Subject has been taking any PPI at standard dose for at least 8 weeks Subject has persistent symptoms during PPI therapy with GERDQ score =8

• An upper gastrointestinal endoscopy is required within the past 1 year to confirm the absence of mucosal breaks, peptic ulcer and other GI diseases e.g. gastric outlet obstruction

Exclusion Criteria:

• Patients that have not experienced any GERD symptom improvement at all during PPI treatment

• Unstable or clinically significant cardiovascular, respiratory, hepatic, renal, metabolic, psychiatric, other clinical disorders, or gastrointestinal and esophageal disorders besides GERD. Clinically significant is defined as disorders that could compromise patients' safety or interfere with the evaluation of the study as judged by the investigator.

• History of or current malignant disease

• Subject is pregnant or lactating

• Prior surgery of the upper GI tract (open, endoscopic and laparoscopic surgery on the esophagus, the stomach and the duodenum)

• Illiterate patient (who cannot administer questionnaire)

• Known hypersensitivity to any PPI

Related Conditions & MeSH terms

• Gastro-esophageal Reflux Disease
• Gastroesophageal Reflux

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PASS_C questionnaire	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.	One year