Retrospective Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Surg. May 27, 2020; 12(5): 236-246
Published online May 27, 2020. doi: 10.4240/wjgs.v12.i5.236
Software improvement for evaluation of laryngopharyngeal pH testing (Restech) – a comparison between DataView 3 and 4
Dolores Thea Müller, Elena Schulte, Benjamin Babic, Laura Knepper, Claudia Fuchs, Wolfgang Schröder, Christiane J Bruns, Jessica M Leers, Hans Friedrich Fuchs
Dolores Thea Müller, Elena Schulte, Benjamin Babic, Laura Knepper, Claudia Fuchs, Wolfgang Schröder, Christiane J Bruns, Jessica M Leers, Hans Friedrich Fuchs, Department of General, Visceral, Cancer and Transplant Surgery, University of Cologne, Köln 50937, Germany
Author contributions: Fuchs HF and Müller DT designed and performed the research and wrote the paper; Fuchs HF, Müller DT and Schulte E contributed to data management; Fuchs HF, Babic B, Müller DT, Leers JM, Schröder W and Bruns CJ contributed to statistical analysis and interpretation of data; Fuchs HF, Babic B, Müller DT, Knepper L, Schulte E, Fuchs C, Schröder W, Bruns CJ and Leers JM revision of the manuscript for important intellectual content.
Institutional review board statement: This study was reviewed and approved by the Ethics Committee of the Medical Faculty of the University of Cologne.
Informed consent statement: Signed informed consent forms were deemed unnecessary by our institutional review board due the retrospective study design. The study conforms to the provisions of the Declaration of Helsinki in 1995 (as revised in Edinburgh 2000). Patient anonymity was preserved.
Conflict-of-interest statement: Dolores Müller has received an educational grant from Restech. All other authors have nothing to disclose.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Hans Friedrich Fuchs, MD, Assistant Professor, Surgeon, Department of General, Visceral, Cancer and Transplant Surgery, University of Cologne, Kerpener Straße 62, Köln 50937, Germany. hans.fuchs@uk-koeln.de
Received: December 30, 2019
Peer-review started: December 30, 2019
First decision: April 3, 2020
Revised: April 9, 2020
Accepted: May 5, 2020
Article in press: May 5, 2020
Published online: May 27, 2020
Processing time: 144 Days and 18.8 Hours
Abstract
BACKGROUND

When gastroesophageal reflux contents reach above the upper esophageal sphincter, patients may, in addition to typical reflux symptoms, present with atypical, extraesophageal symptoms related to laryngopharyngeal reflux (LPR). Surgical treatment of LPR has shown to lead to 70% symptom improvement, however no gold standard for the diagnosis of LPR exists. In 2007, the Restech Dx-pH was released as a valid method to measure acid exposure above the upper esophageal sphincter. Recently, a new software update was introduced for analysis of measured pH data and calculation of composite scores. The effect of the changes applied to the new software version have not yet been analyzed.

AIM

To compare results generated by DataView 3 to the most recently released DataView 4.

METHODS

All patients with gastroesophageal reflux disease symptoms were seen in a specialized surgical outpatient clinic for gastrointestinal function testing. Retrospective chart review was performed of all patients presenting with suspected gastroesophageal reflux disease and extraesophageal reflux symptoms, who underwent laryngopharyngeal pH monitoring using the Restech Dx-pH system (Respiratory Technology Corp., Houston, TX, United States) and simultaneous esophageal pH monitoring. DataView 3 and DataView 4 were used to evaluate Restech studies obtained. Diary entries such as mealtimes, supine and upright periods, and symptoms were entered manually to ensure accuracy and precise conversion of data between both software versions. Paired t test was performed for statistical analysis of results.

RESULTS

A total of 174 patients (63.8% female) met inclusion criteria, all suffering from extraesophageal reflux symptoms as well as typical gastroesophageal reflux disease symptoms. Mean RYAN score upright was 48.77 in DataView 3 compared to 22.17 in DataView 4, showing a significant difference (aP = 0.0001). Similar results were shown for supine period (mean RYAN Score DataView 3 5.29 vs 1.42 in DataView 4, cP = 0.0001). For upright periods 80 patients showed a decrease of value of the RYAN score with a mean of -58.9 (mean 51.1% decrease). For supine position 25 patients showed a decrease of value of the RYAN score with a mean of -15.13 [range (-153.44)–(-0.01)], which equals a mean decrease of value of 44.5%. Ten patients showed no oropharyngeal acid exposure in DataView 3, but mild/moderate (n = 7) or severe (n = 3) acid exposure in DataView 4. Correlation with positive esophageal pH measurement was improved in all 10 patients.

CONCLUSION

Results of both software versions cannot be compared to each other. However, our data suggests that DataView 4 may be an improvement of the Restech pH measurement in the evaluation of LPR.

Keywords: Gastroesophageal reflux disease; Laryngopharyngeal reflux disease; Esophageal pH testing; Oropharyngeal pH testing; Restech Dx pH; DeMeester score; RYAN Score

Core tip: The Restech Dx-pH is a valid method to measure acid exposure above the upper esophageal sphincter. However, recently a new software update was introduced for calculation of composite scores. Patients with extraesophageal reflux symptoms, who underwent laryngopharyngeal pH monitoring using the Restech Dx-pH system and simultaneous esophageal pH monitoring were evaluated using DataView 3 and DataView 4. A total of 174 patients met inclusion criteria. Mean RYAN score upright and supine differed significantly between both software versions (a,cP = 0.0001) with composite scores mostly decreasing. Our data suggests that DataView 4 may be an improvement of the Restech pH measurement in the evaluation of laryngopharyngeal reflux.