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25 Years of the GERD-HRQL symptom severity instrument: an assessment of published applications

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Vic Velanovich at USF Health Byrd Alzheimer's Institute
Vic Velanovich
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Background: The GERD-HRQL symptom severity instrument was developed and published 25 years ago. This seems like an apropos time to review how the instrument has been used in the "real-world." Methods: Google Scholar, PubMed, and Web of Science websites search was done using the keywords "GERD-HRQL" or its author, "Velanovich." Once articles were identified, the following information was obtained from each article: first author name, country of origin, journal published, year of publications, type of study design, subject of study, category of study, disease type studied, purpose of the study, how the GERD-HRQL scores were reported, how the GERD-HRQL scores were statistically reported, and results of the study. The total and change of scores were analyzed for descriptive statistics based on disease process studied and intervention studied. Results: A total of 767 articles by 562 different first authors were identified in 193 different journals from 53 different countries of study origin. After a period of steady usages, the number of publication employing the GERD-HRQL has rapidly increase over the last 5 years. There have been 8 validated translations into other languages, although there appears to be numerous, non-validated ad hoc translations. Most commonly used or studied: observational cohort study design, surgical treatment study category, GERD disease process, treatment effect study purpose, total GERD-HRQL scores reported as means or medians. However, there were a wide variety of other study designs, study categories, disease processes, and study purposes. In general, GERD and laryngopharyngeal reflux had the high pre-treatment scores (i.e., more severe symptoms), and surgical and endoscopic interventions the lowest post-treatment score (i.e., least severe symptoms) with the largest change in score (i.e., treatment impact. Conclusions: The GERD-HRQL has proven to be a reliable, responsive and versatile symptom severity instrument for studies involving GERD as a subject.
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Surgical Endoscopy (2023) 37:255–265
https://doi.org/10.1007/s00464-022-09463-9
ORIGINAL ARTICLE
25 Years oftheGERD‑HRQL symptom severity instrument:
anassessment ofpublished applications
VicVelanovich1
Received: 10 March 2022 / Accepted: 11 July 2022 / Published online: 3 August 2022
© The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature 2022
Abstract
Background The GERD-HRQL symptom severity instrument was developed and published 25years ago. This seems like
an apropos time to review how the instrument has been used in the “real-world.”
Methods Google Scholar, PubMed, and Web of Science websites search was done using the keywords “GERD-HRQL” or
its author, “Velanovich.” Once articles were identified, the following information was obtained from each article: first author
name, country of origin, journal published, year of publications, type of study design, subject of study, category of study,
disease type studied, purpose of the study, how the GERD-HRQL scores were reported, how the GERD-HRQL scores were
statistically reported, and results of the study. The total and change of scores were analyzed for descriptive statistics based
on disease process studied and intervention studied.
Results A total of 767 articles by 562 different first authors were identified in 193 different journals from 53 different coun-
tries of study origin. After a period of steady usages, the number of publication employing the GERD-HRQL has rapidly
increase over the last 5years. There have been 8 validated translations into other languages, although there appears to be
numerous, non-validated ad hoc translations. Most commonly used or studied: observational cohort study design, surgical
treatment study category, GERD disease process, treatment effect study purpose, total GERD-HRQL scores reported as
means or medians. However, there were a wide variety of other study designs, study categories, disease processes, and study
purposes. In general, GERD and laryngopharyngeal reflux had the high pre-treatment scores (i.e., more severe symptoms),
and surgical and endoscopic interventions the lowest post-treatment score (i.e., least severe symptoms) with the largest
change in score (i.e., treatment impact.
Conclusions The GERD-HRQL has proven to be a reliable, responsive and versatile symptom severity instrument for studies
involving GERD as a subject.
Keywords The GERD-HRQL symptom severity instrument· Quality-of-life instrument· Patient-reported outcomes·
Gastroesophageal reflux disease· Antireflux treatments
The Gastroesophageal Reflux Disease-Health-Related
Quality-of-Life (GERD-HRQL) instrument was developed
in 1995 to assess the intensity of the typical symptoms of
gastroesophageal reflux disease (GERD), and eventually
published in 1996 [1]. At the time, there were very few dis-
ease-specific instruments assessing quality of life in patients
with GERD. The instrument contains 10 items related to
different aspects of GERD symptoms, with each item rated
from 0 to 5 on an anchor-based Likert scale (Fig.1). Each
individual item score is based on a symptom description
“anchor” so that there will be relative consistency in patient
response at nearly similar degree of symptom severity. The
scores of each individual item are added together to reach a
total score which ranges from 0 (the best possible score) to
50 (the worst possible score). Therefore, there are 51 pos-
sible scores, leading to relatively high precision in assessing
symptom severity. In addition, the instrument also assesses a
global satisfaction level as satisfied, neutral, and dissatisfied
(Fig.1). A review of the development of the GERD-HRQL
with respect to validity, reliability, responsiveness, and prac-
ticality was published in 2007 [2].
and Other Interventional Te
chniques
* Vic Velanovich
vvelanov@usf.edu
1 The Division ofGastrointestinal Surgery, University
ofSouth Florida Morsani College ofMedicine, 5 Tampa
General Circle, Suite 740, Tampa, FL33606, USA
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
... The maximum score is 50, with higher scores associated with worse burden of disease and poorer quality of life. The GERD-HRQL has been utilized as a disease-specific quality of life survey for 25 years in over 700 peer-reviewed studies [16]. Additional outcomes included PPI use, overall satisfaction with the surgical outcome, and if they would have, in hindsight, have undergone the operation. ...
... Patients with borderline GERD who are being counseled on potential operative anti-reflux intervention should be told that they are likely to benefit from surgery, but potentially less so than patients with more severe symptoms. Prior studies of GERD-HRQL improvements after fundoplication have noted absolute score improvements of over 50% the original score, with an aggregate of 150 studies demonstrating an average improvement of 18 points after surgical anti-reflux procedure [15,16]. For our cohort, though all patients had significant improvements in their GERD-HRQL, the absolute improvement after surgery at long-term follow-up was 12 points for the borderline group compared to 21 points for the GERD group. ...
Long-term disease-specific quality of life after laparoscopic Nissen fundoplication in patients with borderline GERD
Article
Full-text available
  • Aug 2024
  • SURG ENDOSC
Background Historically, DeMeester score over 14.7 has been used to diagnose GERD. The 2022 American Gastroenterological Association clinical guidelines define GERD based on acid exposure time (AET) instead of DeMeester score. We aim to compare outcomes after laparoscopic Nissen fundoplication (LNF) in patients based on differing GERD diagnostic criteria. Methods Patients who underwent first-time LNF between 2009 and 2017 were identified. Demographics, objective GERD evaluation, and outcomes were maintained in an IRB-approved database. Disease-specific quality of life was assessed with a survey (GERD-HRQL) with higher values representing more symptomatic disease. Descriptive statistics, Fischer’s exact test and logistic regression were used to analyze the data, p-value < 0.05. Results 225 patients were stratified into two groups: borderline GERD (AET 4–6%, n = 25.11%) and GERD (AET ≥ 6%, n = 200.89%). The mean age was 50.1 ± 13.4 years and 169 (75%) were female. Baseline GERD-HRQL was lower in the borderline group (24.3 vs 30.0, p = 0.031). Short-term (5 weeks [IQR 4, 8]), medium-term (14 months [IQR 7.25, 31]) and long-term (6.75 years [IQR 5.5, 8]) follow-up was performed. GERD-HRQL scores did not differ between borderline and GERD patients at short-(6.0 vs 7.1, p = 0.630), medium-(12.0 vs 12.1, p = 0.818), or long-term follow-up (10.0 vs 9.0, p = 0.757). The absolute long-term improvement in GERD-HRQL was −12.3 (p = 0.022) vs. −21.3 (p < 0.001). At long-term follow-up there was no difference in PPI use (50% vs 47%, p = 0.852), satisfaction (58% vs 76%, p = 0.187), willingness to repeat the procedure given the benefit of hindsight (75% vs 85%, p = 0.386), or need for reoperation (14% vs 13%, p = 0.910). Conclusion Both patients with borderline GERD and GERD achieve GERD-HRQL improvements at 7 years following laparoscopic Nissen fundoplication and demonstrate similar long-term PPI usage and satisfaction with surgical results. Borderline GERD patients have lower GERD-HRQL at baseline, and thus have smaller improvements in their QOL scores. Anti-reflux surgery should be considered for patients with a diagnosis of borderline GERD refractory to medical therapy.
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... Future work may aim to compare these cohorts. Additionally, the most common method of reporting GERD-HRQL is total score and proportion of patients with > 50% improvement from baseline [25], however, given the retrospective nature of this trial, we are unable to obtain pre-operative baseline QOL scores. Though patients report low symptom severity overall, this lack of baseline data limits our ability to generate definitive conclusions regarding QOL improvement after redo repair and its relationship with decision regret. ...
Patient reported outcomes and decision regret scores in redo-paraesophageal hernia repair
Article
Full-text available
  • Dec 2024
  • SURG ENDOSC
Introduction Recurrent paraesophageal hernia (PEH) repair presents significant technical challenges, with limited data weighing the benefit to the operative risk. This study aims to describe our experience with recurrent PEH repair, including long-term surgical and patient reported outcomes (PROs). Methods We conducted a retrospective review of recurrent PEH repairs from June 2018—March 2023 using our institutional database. A blinded review of post-operative imaging was conducted to assess for recurrence. Quality of life (QOL) and decision regret were measured using the GERD Health-Related Quality-of-Life (GERD-HRQL) questionnaire and Decision Regret Scale (DRS) at maximum follow up. Results Eighty-eight patients underwent recurrent PEH repair at our institution for PEH, classified as type II (13.6%), type III (72.7%) and type IV (13.6%). There was significant heterogeneity in operative techniques used: one-third of patients had mesh placed at the hiatus, 11.4% had a Collis gastroplasty, and one-third of patients underwent fundoplication. Intraoperative complications included gastric (5.7%), esophageal (2.3%), vascular (1.1%) and pulmonary (1.1%) injuries. Follow up was available for 73 patients with median follow up of 35.2 months. Of patients with radiographic follow up, 20 (35.7%) had a radiographic recurrence: 12 (21.4%) were 2–5 cm and 8 (14.3%) were > 5 cm. Patients reporting PROs (53 patients; 60.2%) reported low symptom severity (mean GERD-HRQL 13.1 ± 12) and low decision regret (mean DRS 13.3 ± 19.4) with 75.5% scoring in the lowest quartile (DRS < 25). Radiographic recurrence was associated with worse QOL (p < 0.05), but no significant difference in decision regret (p = 0.125). Conclusion We found significant heterogeneity amongst recurrent PEH repair techniques with continued high recurrence rate during follow up. Radiographic recurrence was correlated with worse QOL, yet patients reported low symptom severity and low decision regret, suggesting continued value in these challenging operations. Future studies should aim to identify more effective techniques to reduce recurrence rates in this patient population.
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... Studies have shown that the GERD-HRQL is more effective than generic quality-of-life instruments, such as the SF-36, in capturing the unique impact of GERD symptoms on patients' lives [10]. Additionally, the GERD-HRQL has been translated into multiple languages, with its validity and reliability confirmed across various cultural contexts [11]. ...
Correlation of the Endoscopic Esophagogastric Junction Integrity with Symptomatic GERD in Patients Undergoing Work-Up for Metabolic and Bariatric Surgery
Article
Full-text available
  • Nov 2024
  • OBES SURG
Background Gastroesophageal reflux disease (GERD) is a common adverse effect after metabolic and bariatric surgery (MBS). Identifying patients with preexisting GERD is critical for preoperative planning. The American Foregut Society (AFS) recently proposed a new endoscopic classification system for objective assessment of the esophagogastric junction (EGJ) integrity, building upon the Hill classification. Grade 1 represents an intact EGJ, while grades 2, 3, and 4 represent partial, moderate, and complete disruption of the ARB. Unlike Hill classification, the AFS classification includes objective measurement of hiatal axial length and aperture diameter. The study aimed to evaluate the ability of the AFS hiatus classification to predict GERD severity using symptom questionnaires. Methods We performed a prospective study of obese patients who underwent endoscopy as work-up for MBS. The endoscopy was evaluated for esophagitis, Barrett’s esophagus, and AFS grade. All patients were also surveyed preoperatively with the GERD-HRQL, GerdQ, and RSI. The correlation between AFS grades and questionnaire scores was analyzed using Spearman’s test. Results A total of 393 patients were included in the study. There were 81% female, with a mean age of 36 ± 10.7 years and a mean BMI of 41.7 ± 7.2 kg/m². The AFS grades were distributed as follows: 11 (2.8%) patients had grade 1; 137 (34.9%) had grade 2; 162 (41.2%) had grade 3; and 83 (21.1%) had grade 4. There was a positive but weak correlation between AFS grades and all scoring systems, including GERD-HRQL (r = 0.201), heartburn (r = 0.203), regurgitation (r = 0.212), RSI (r = 0.110), and GerdQ scores (r = 0.202). However, the proportion of patients with esophagitis increased progressively with increasing grades (0% in grade 1, 2.2% in grade 2, 9.9% in grade 3, and 32.5% in grade 4, p = 0.01). Conclusion The AFS hiatus classification can stratify the population with obesity based on rate of esophagitis and symptom scores. This study supports the practical utility of the AFS classification as an adjunct in the detection of patients who are at risk for GERD after MBS. Further validation studies with pH testing are needed.
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... Preoperatively and postoperatively, all patients responded to the Korean version of the GERD questionnaire for the diagnosis of GERD [22] , along with the gastroesophageal reflux disease-healthrelated-quality-of-life (GERD-HRQL) instrument for assessing the intensity of reflux symptoms [23,24] . The Korean version of the GERD questionnaire consists of a discontinuous scale ranging from 0 (no symptoms) to 10 (very severe) in terms of typical (heartburn, regurgitation, and epigastric pain) and atypical symptoms. ...
Bolus exposure as a novel predictor of postoperative symptom resolution after laparoscopic nissen fundoplication: A two-institutional retrospective cohort study
Article
Full-text available
  • Oct 2024
  • Int J Surg
Background Even in the absence of definite evidence of pathological acid reflux, antireflux surgery (ARS) can still effectively improve gastroesophageal reflux symptoms. Nonetheless, predicting postoperative reflux symptom improvement has been primarily dependent on acid-based parameters. No objective index reflecting both acid and non-acid reflux was identified to select ARS candidates. Materials and methods Prospectively collected data of 121 patients with gastroesophageal reflux disease (GERD), who underwent laparoscopic Nissen fundoplication from two institutions, were retrospectively reviewed. The patients reported preoperative and postoperative GERD symptoms using the Korean version of the GERD questionnaire, along with the gastroesophageal reflux disease-health-related quality of life (GERD-HRQL). The patients assessed for reflux symptoms using bolus exposure, acid exposure time (AET), and DeMeester score (DMS) as measurements were selected. For each reflux parameter, its association, correlation, and predictive capacity of the degree of postoperative symptom resolution were analyzed using chi-squared tests, point-biserial correlations, logistic regression analyses, and receiver operating characteristic curve analyses. Results 72 patients were eligible for this study. Bolus exposure was superior to the other parameters in terms of the degree of association and correlation with resolution of typical symptoms. Bolus exposure also showed a higher diagnostic accuracy in predicting the resolution of epigastric pain (area under the curve [AUC]=0.723, P =0.013) and regurgitation (AUC=0.981, P <0.001). Secondary analyses were performed in patients without pathological reflux, defined as the DMS-negative (DMS<14.7) or AET-negative (AET<6%) groups. In the secondary analyses, bolus exposure showed considerable diagnostic accuracy with statistical significance for all typical symptoms in both in the DMS-negative (heartburn: AUC=0.717, P =0.025; epigastric pain: AUC=0.717, P =0.025; regurgitation: AUC=0.975, P <0.001) and AET-negative (heartburn: AUC=0.681, P =0.045; epigastric pain: AUC=0.749, P =0.009; regurgitation: AUC=0.975, P <0.001) groups. Conclusion Bolus exposure, a parameter of total reflux, was superior to AET or DMS in defining candidates for ARS. Further studies investigating the surgical indications for ARS in patients with non-acid reflux using bolus exposure are required.
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... The primary study population in this study was from 236 patients who underwent LSG from April 2014 to April 2023 in Zhejiang Provincial People's Hospital. All patients undergoing surgery in this study completed the GERD-Health-Related Quality of Life (GERD-HRQL) questionnaire preoperatively and 6 months postoperatively, respectively 9 . The inclusion criteria were as follows: (1) Patients with a BMI ≥ 30 kg/m 2 who underwent laparoscopic sleeve gastrectomy at our center; (2) Adults aged 18-65 years; (3) Signed informed consent to participate in the study. ...
Development and validation of a novel nomogram to predict worsening of gastroesophageal reflux symptoms after laparoscopic sleeve gastrectomy using Lasso-logistic regression
Article
Full-text available
  • Oct 2024
Background Gastroesophageal reflux disease (GERD) is among the most common complications of bariatric surgery. This study aimed to analyse the risk factors affecting the worsening of GERD symptoms after laparoscopic sleeve gastrectomy (LSG), and to establish and validate a related nomogram model. Methods The study recruited 236 participants and randomly divided them into training and validation sets in a ratio of 7:3. LASSO regression technique was used to select the optimal predictive features, and multivariate logistic regression was used to construct the column line graphs. The performance of the nomogram was evaluated and validated by analyzing the area under the receiver operating characteristic (ROC) curve, calibration curve, and decision curve. Results In this study, Lasso-logistic regression was applied to select 5 predictors from the relevant variables, which were body mass index (BMI), diabetes, hiatal hernia, GERD, and triglyceride levels. These 5 predictor variables constructed a model with moderate predictive power, with an area under the ROC curve of 0.779 for the training set and 0.796 for the validation set. Decision curve analysis showed that in external validation, if the risk thresholds were between 4 and 98% and 14–95%, then the nomogram can be applied to the clinic. Conclusions We have developed and validated a nomogram that effectively predicts the risk of worsening gastroesophageal reflux symptoms following LSG.
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... The Gastroesophageal Reflux Disease-Health-related Quality of Life (GERD-HRQL) questionnaire was used to assess the quality of life. 19,20 After overnight fasting, the patients underwent high-resolution manometry and MII-pH. The following day, after removing the MII-pH catheter, the patients underwent UGE without prior knowledge of the results of the other tests. ...
Esophageal Mucosal Impedance Assessment for the Diagnosis of Gastroesophageal Reflux Disease
Article
Full-text available
  • Jul 2024
Background/aims: Diagnosing gastroesophageal reflux disease (GERD) is sometimes challenging because the performance of available tests is not entirely satisfactory. This study aims to directly measure the esophageal mucosal impedance during upper gastrointestinal endoscopy for the diagnosis of GERD. Methods: Sixty participants with typical symptoms of GERD underwent high-resolution esophageal manometry, 24-hour multichannel intraluminal impedance-pH monitoring, upper gastrointestinal endoscopy, and mucosal impedance measurement. Mucosal impedance measurement was performed at 2, 5, 10, and 18 cm above the esophagogastric junction during gastrointestinal endoscopy using a specific catheter developed based on devices described in the literature over the last decade. The patients were divided into groups A (acid exposure time < 4%) and B (acid exposure time ≥ 4%). Results: The mucosal impedance was significantly lower in group B at 2 cm (2264.4 Ω ± 1099.0 vs 4575.0 Ω ± 1407.6 [group A]) and 5 cm above the esophagogastric junction (4221.2 Ω ± 2623.7 vs 5888.2 Ω ± 2529.4 [group A]). There was no significant difference in the mucosal impedance between the 2 groups at 10 cm and 18 cm above the esophagogastric junction. Mucosal impedance value at 2 cm > 2970 Ω resulted in a sensitivity of 96.4% and a specificity of 87.5% to exclude GERD. Conclusions: Direct measurement of mucosal impedance during endoscopy is a simple and promising method for diagnosing GERD. Individuals with an abnormal acid exposure time have lower mucosal impedance measurements than those with a normal acid exposure time.
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... The preoperative work-up consisted of an upper endoscopy with biopsies of the distal oesophagus, a standardised history and physical examination, and a standardised questionnaire for reflux disease (GERD-HRQL, 0-75 points plus an additional quality-of-life question [12]); see figure S1 in the Appendix for the original questionnaire used. Oesophageal motility was assessed by video oesophagram under fluoroscopy, with the contrast-enhanced liquid medium swallowed in upright and supine positions according to a standardised protocol [13]. ...
Exploring the feasibility and safety of laparoscopic anti-reflux surgery with the new RefluxStop™ device: a retrospective cohort study of 40 patients: Laparoscopic Reflux Surgery with RefluxStop
Article
Full-text available
  • Jul 2024
  • SWISS MED WKLY
AIMS OF THE STUDY: Anti-reflux surgery aims to restore the anti-reflux barrier and reduce the retrograde flow of stomach contents. However, traditional surgical techniques generally involve some degree of encircling of the oesophagus, which can result in adverse effects such as dysphagia and the inability to belch or vomit. Based on the first published results, a novel surgical technique – with the RefluxStop™ device – appears promising for treating gastroesophageal reflux disease (GERD) with minimal postoperative dysphagia. This study describes the initial clinical experience with this procedure in a cohort of patients with chronic gastroesophageal reflux disease to evaluate its feasibility and safety in clinical practice. METHODS: This retrospective cohort study examined the first 40 patients who underwent laparoscopic anti-reflux surgery with the RefluxStop™ device at a private hospital in Switzerland. The procedure involves implanting a nonactive device on the outside of the gastric fundus to stabilise a narrow oesophagogastric plication. Feasibility was assessed based on the proportion of patients in whom the device could be successfully implanted, with a discussion of the operative details. Intraoperative and postoperative complications, adverse effects, and changes in gastroesophageal reflux disease-related quality of life (GERD-HRQL questionnaire) are also reported. RESULTS: Between May 2020 and April 2022, 40 patients underwent elective surgery for laparoscopic hiatal hernia repair and RefluxStop™ device implantation. All patients had typical symptoms of gastroesophageal reflux disease, such as heartburn and regurgitation; 20 (50%) had preoperative dysphagia. Laparoscopic surgery was feasible in all patients except one who required laparotomy due to adhesions and associated bleeding when accessing the abdomen. The median operating time was 57.5 minutes (interquartile range = 51.75–64.25 minutes) with no device-related intraoperative or postoperative complications. All patients were imaged one day and three months postoperative, confirming the correct placement of the device. Reflux symptoms (heartburn and acid regurgitation) were significantly improved in all patients at three months (p <0.0001). CONCLUSION: These preliminary results support the feasibility and safety of introducing this novel laparoscopic anti-reflux surgical treatment option in clinical practice.
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... To assess GERD symptoms, we employed the wellestablished 16-item GERD-HRQL questionnaire [13,14] ( Fig. 1). This questionnaire was administered to patients during their last visit before surgery and evaluates typical symptoms of GERD over a 2-week recall period. ...
Upper Gastrointestinal Endoscopic Screening in Bariatric Surgery Candidates: Correlating the Findings with GERD symptoms
Article
Full-text available
  • Jul 2024
  • OBES SURG
Introduction The role of routine preoperative esophagogastroduodenoscopy (EGD) in bariatric surgery candidates is controversial. This study compares preoperative EGD outcomes with patient-reported gastroesophageal reflux disease (GERD) symptoms to determine if a case-based EGD is appropriate. Patients and Methods A prospective cohort study was conducted from April 2022 through September 2023 in Mashhad, Iran. All patients underwent EGD. To assess GERD symptoms, we used the GERD-Health Related Quality of Life questionnaire. Patients were categorized into two groups: the asymptomatic group (GERD-HRQL = 0) and the symptomatic group (GERD-HRQL > 0). Results A total of 165 patients were included, out of which 133 (80.6%) were in the symptomatic group and 32 (19.4%) were in the asymptomatic group. Esophagitis was present in 41 (24.8%) patients. There was no significant difference in the frequency of esophagitis (18.8% vs. 26.3%, p-value = 0.37), hiatal hernia (18.8% vs. 18.8%, p-value = 1.00), gastritis (56.3% vs. 63.9%, p-value = 0.42), and H. pylori infection (9.4% vs. 12.0%, p-value = 1.00) between the asymptomatic and symptomatic groups, respectively. None of the demographic factors or comorbidities of asymptomatic patients were associated with esophagitis, except for hiatal hernia (OR = 7.67, 95% CI 3.01–19.53, p-value < 0.001). Receiver operating characteristic (ROC) analysis showed that the GERD-HRQL total scores, as well as the heartburn and regurgitation subscales, were poor predictors of esophagitis (AUC 0.57, 0.51, and 0.56, respectively). Conclusion EGD findings were not associated with GERD symptoms in candidates for bariatric surgery. Graphical Abstract
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Experience With an Innovative Surgical Treatment Option for Gastroesophageal Reflux Disease: Results of 28 Patients in a Retrospective Analysis
Article
  • Mar 2025
  • J LAPAROENDOSC ADV S
Introduction: Standard-of-care gastroesophageal reflux disease (GERD) procedures are associated with adverse events (AEs) (i.e., dysphagia, gas-bloating). RefluxStop has been developed to circumvent these outcomes. This study presents the results of 28 patients managed with RefluxStop in Germany. Methods: Between July 2021 and November 2023, 28 patients with GERD underwent RefluxStop surgery, a novel laparoscopic antireflux procedure. Retrospective chart analysis with patient-informed consent was conducted to determine clinical outcomes, such as GERD Health-Related Quality of Life (GERD-HRQL) score, proton pump inhibitors (PPI) use, symptomatology, patient satisfaction, and perioperative AEs. Results: Baseline characteristics (n = 28): age 47 ± 13.1 years; 67.9% female; body mass index (BMI) 27.3 ± 4.1 kg/m2; 93% PPI use for 5.6 ± 2.7 years; and hiatal hernia in 100% of cases of mean (standard deviation [SD]) size 3.4 (0.8) cm, whereof 35.7% were large hiatal hernia (4-6 cm). At a mean (SD) follow-up of 14.1 (4.7) months, patients experienced 88.6% improvement in median (IQR) total GERD-HRQL score from a baseline of 35 (7.7) to 4 (4.2) at follow-up (P < .05). Preoperative dysphagia (35.7%) resolved completely in all patients (P < .001). The mean (SD) GERD-HRQL heartburn subdomain decreased by 90.6% from a baseline of 18.1 (6.1) to 1.7 (1.2) at follow-up and all patients (100%) had scores <5. Similarly, the mean (SD) regurgitation subdomain decreased from a baseline of 13.2 (4.7) to 2 (1.6) at follow-up and all patients (100%) had scores <5. Patient satisfaction was achieved in 96.4% of patients with no PPI use required in 93% of patients (P < .001); only one patient required PPIs for persistent GERD symptoms. No cases of reoperation or esophageal dilatation were performed. Minor intraoperative AEs occurred in seven patients (i.e., neck emphysema). Conclusion: RefluxStop provides excellent safety and effectiveness outcomes for GERD treatment. Dysphagia completely resolved (0%) with 88.6% improvement in median GERD-HRQL score and satisfaction achieved in 96.4% of patients. These promising results reproduced the outcomes noted in the RefluxStop CE trial in real-world settings.
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Antireflux mucosal valvuloplasty versus proton pump inhibitors for the treatment of patients with gastro-oesophageal reflux disease in a tertiary healthcare centre in China: study protocol for a randomised controlled trial
Article
Full-text available
  • Dec 2024
Introduction Endoscopic antireflux therapy has shown promising potential in the treatment for gastro-oesophageal reflux disease (GERD). However, there is currently no universally accepted standard for endoscopic surgery. Therefore, we introduced antireflux mucosal valvuloplasty (ARMV), an innovative endoscopic treatment for GERD. We have conducted a cohort study to assess the association between ARMV and clinical outcomes, including risks and benefits. The objective of this trail is to compare the efficacy of ARMV with proton pump inhibitors (PPIs) therapy. Methods and analysis 74 patients with chronic GERD will be randomised (1:1) to undergo either ARMV or continue PPI therapy. The primary endpoint is the GERD health-related quality of life score, measured 6 months postprocedure. Secondary endpoints include the GERD questionnaire score, presence of reflux oesophagitis, appearance of the mucosal flap, DeMeester score, PPI usage and the incidence of adverse events. After 6 months, crossover is allowed for the PPI group. Assessments will occur at baseline and at 3, 6, 12, 24 and 36 months postintervention. Ethics and dissemination The study protocol has been approved by the Institutional Review Board of Qilu Hospital, Shandong University. Study results will be disseminated through peer-reviewed journals and presented at scientific conferences. Trial registration number ClinicalTrials.gov (NCT 06348420).
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Testing and validation of the Russian version of quality of life questionnaire in patients with GERD – GERD-HRQL
Article
Full-text available
  • Dec 2020
Aim.This study aimed to test the Russian version of GERD-HRQL in the focus group of patients with GERD, as well as to evaluate its psychometric properties reliability, validity and sensitivity. Materials and methods.The total of 57 patients with GERD (mean age 45.812.4 years, 72% women, 68% patients with not erosive reflux disease, 84% had esophageal manifestations of GERD) were enrolled into the study. All the patients filled out the Russian version of GERD-HRQL and generic quality of life questionnaire RAND SF-36 during the routine visit to the gastroenterologist. According to the results of testing of GERD-HRQL, it was clear and easy to complete for patients and reflected the main concerns specific for GERD patients. The most frequent and bothersome symptoms/problems which interfered with quality of life in GERD patients were heartburn (100% of patients) and bloating (84% of patients). During the validation procedure, the high reliability and validity of the Russian version of GERD-HRQL were demonstrated. It was shown that the tool was sensitive both to changes over time and to clinically determined differences in patients status. Results.The Total GERD-HRQL Score was significantly higher (worse quality of life) in the following groups: a) patients who had esophageal manifestations of GERB vs those without esophageal manifestations of GERB; b) patients with GERD complications vs those without GERD complications, c) patients with comorbidities of upper gastrointestinal tract vs without those comorbidities; d) patients with erosive esophagitis vs with non-erosive reflux disease (p0.05). Conclusion.The developed Russian version of the GERD-HRQL questionnaire proved to have high psychometric properties and may be used in the Russian population of GERD patients both in research studies and in a real clinical practice.
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Effect of Catgut Embedment in Du Meridian Acupoint on Mental and Psychological Conditions of Patients with Gastroesophageal Reflux Disease
Article
Full-text available
  • Sep 2020
  • EVID-BASED COMPL ALT
Objective. To observe the influence of the catgut-embedding method in Du Meridian acupoint on the mental and psychological state of patients with gastroesophageal reflux disease (GERD) and analyze its possible mechanism. Methods. According to the random number table, 60 patients with GERD were randomly divided into groups of acupoint catgut embedding and Western medicine, 30 cases in each group. The acupoint group was given catgut embedment in the positive reaction points along the Du Meridian, while the Western medicine group received lansoprazole tablet. They were both treated for six weeks. Scores of Gastroesophageal Reflux Disease Questionnaire (GerdQ), Zung’s Self-Rating Anxiety Scale (SAS), Zung’s Self-Rating Depression Scale (SDS), and Health-Related Quality of Life Scale for GERD (GERD-HRQL) were measured before and after treatment to analyze and evaluate the differences of symptom scores and mental and psychological conditions between the two groups. Results. (1) The scores of GerdQ, GERD-HRQL, SAS, and SDS in the two groups both significantly decreased after treatment (), and those of the acupoint group were much lower than the Western medicine group (). (2) The total effective rate was 90.00% in the acupoint group and 53.33% in the Western medicine group, with a statistically significant difference (). (3) The correlation coefficients r between the GerdQ score and scores of SAS and SDS were 0.563 and 0.322, respectively, and those between the GERD-HRQL score and scores of SAS and SDS were, respectively, 0.506 and 0.435. Conclusion. (1) The main symptoms of GERD patients, such as acid reflux and heartburn, mental and psychological condition, and quality of life, were all improved in the two groups, but the efficacy in the acupoint group is superior to that of the Western medicine group. (2) The clinical symptoms and scores of patients’ quality of life are positively correlated with the degree of their anxiety and depression. (3) The acupoint catgut-embedding method can effectively regulate the anxiety and depressive symptoms of patients, which complements the efficacy of proton-pump inhibitors and benefits a wider range of population. 1. Introduction The mental and psychological factors can affect the pathogenesis, diagnosis, and prognosis of gastroesophageal reflux disease (GERD) [1]. They are the important causes of high sensitivity of esophagus viscera, which stimulate the brain to generate signals that travel down to the esophagus and gastrointestinal tract, causing gastrointestinal reactions and abnormal gastric acid secretion and worsening the symptoms of the digestive tract. Long-term suffering of clinical symptoms, in turn, can aggravate patients’ anxiety and depression, leading to autonomic nerve dysfunction. The imbalance between sympathetic and parasympathetic nerves reduces the contraction force of digestive tract circular fold muscle, which further slows down gastric contraction rate, decreases migrating motor complex (MMC) function, and regurgitates stomach acid to the esophagus, eventually generating the reflux esophagitis [2, 3]. Current studies have shown that acupuncture has an accurate therapeutic effect on both the gastrointestinal somatization symptoms caused by psychosocial diseases and the psychosocial symptoms generated together with gastrointestinal diseases, and its efficacy is better than Western medicine in improving some symptoms [4, 5]. The catgut-embedding therapy, an important part of external treatment methods of traditional Chinese medicine, stimulates acupoint with a longer effect than simple acupuncture. It is simple and safe in operation, which can balance yin and yang, dredge qi and blood by stimulating acupoint based on syndrome differentiation of meridians and collaterals so as to reduce symptoms and improve patients’ quality of life. The previous study of our research group has proved that acupuncture and catgut embedment in Du Meridian acupoint have better effects on GERD than oral administration of proton-pump inhibitor (PPI) [6, 7]. On this basis, this study discussed the influence of Du Meridian acupoint catgut embedding on the psychosocial factors of GERD, objectively evaluated its therapeutic effect on the disease, and analyzed its mechanism of improving patients’ psychosocial symptoms, in order to support the application and promotion of Du Meridian catgut-embedding therapy in the future. 2. Clinical Data 2.1. General Information This study was approved by the Hospital Ethics Committee. In this study, 60 patients diagnosed with GERD in the Acupuncture and Moxibustion Department of Nanjing Hospital of Chinese Medicine, the Acupuncture, Moxibustion and Tuina Department of Jiangdong Community Health Service Center, and the National TCM Physician Outpatient Department affiliated to Nanjing University of Chinese Medicine from March 2018 to March 2019 were enrolled, and they or their immediate family members have signed the informed consent. According to the random number table, the subjects were randomly divided into the acupoint catgut-embedding group (30 cases) and the Western medicine group (30 cases). There were 14 males and 16 females in the acupoint group, aged 23–75 years and averaged 50.77 ± 15.73, with a disease duration of 0 to 30 years, averaged 5.42 ± 6.31. In the Western medicine group, there were 11 males and 19 females, aged 19–72 years and averaged 47.30 ± 14.83, with a disease duration of 0 to 20 years, averaged 4.42 ± 5.40. The differences in gender, age, and course of disease between the two groups had no systematic significance () and were comparable. Among the 60 included GERD patients, 5 were identified by electronic gastroscopy as Barrett’s esophagus (BE), 22 were identified as erosive esophagitis (EE), 20 were chronic gastritis, and the rest 10 and 3 cases were identified as chronic superficial gastritis and chronic atrophic gastritis, respectively. 2.2. Diagnostic Criteria It refers to the Montreal definition and classification of gastroesophageal reflux disease (2006) [8] and the Guidelines for the diagnosis and management of gastroesophageal reflux disease (2013) [9]: (1) symptoms of heartburn, gastric acid reflux, noncardiac chest pain, and upper abdominal pain occurred for more than 4 weeks. (2) Erosive esophagitis or Barrett’s esophagus is found by endoscopic examination. (3) For patients with obvious symptoms but having no organic changes under the gastroscope, if the symptoms were alleviated after oral administration of proton-pump inhibitor (PPI), they will be confirmed with GERD. 2.3. Inclusion Criteria Inclusion criteria include (1) people showing in consistence with the diagnostic criteria; (2) age from 18 to 75 years; (3) at least one of the four typical GERD symptoms occurring with a duration longer than 4 weeks; and (4) those who voluntarily signed the informed consent and actively cooperate with the treatment. 2.4. Exclusion Criteria Exclusion criteria include (1) patients outside the inclusion criteria; (2) patients accompanied by gastrointestinal bleeding or intestinal metaplasia under gastroscope; (3) acute abdominal patients with rebound pain according to abdominal examination; (4) those with connective tissue diseases and blood system diseases; (5) those intolerant to endoscopic examination; (6) pregnant and/or lactating women; and (7) those with severe hemorrhagic diseases. 2.5. Reasons for Loss of Contact and Corresponding Measures These include the patients dropping out of the study or abandoning treatment during the study. The solution was to supplement the patient participants into the research group in proportion to 1 : 1. 2.6. Complying with the Study Principle of Blindness The researchers were divided into four groups: the first group randomly assigned subjects; the second was responsible for performing the treatment; the third collected data; and the fourth was responsible for data collation, statistical analysis, and article writing. The four groups separately implemented their tasks. 3. Treatment Methods 3.1. Western Medicine Group The patients were given lansoprazole tablets (Keyilin, 15 mg × 14 tablets, produced by Sichuan Hairong Pharmaceutical Co., Ltd., National Drug Approval Code H20065186), oral administration, 1-2 tablets (15–30 mg) per day for 6 weeks. 3.2. Acupoint Group Acupoint selection: Baihui (DU 20), Dazhui (DU 14), the positive response points to tenderness in the thoracic dorsal segment of Du Meridian (TDSDM). Exploration of positive tenderness points: before treatment, the patient lies in a prone position, fully exposing the back, and both upper limbs are relaxed and naturally placed at the sides of the body. The operator should stand on the right side of the patient and place the right index finger pulp in the depression under the spinous process in the middle of the patient’s back. The patient is then examined from the depression under the T1 spinous process to T9 spinous process depression with continuous and uniform pressure. At the same time, the operator will ask the patient whether there is pain, sour and swelling, and other discomforts, and where the discomfort exists is marked as a positive point, while those without pain or unable to clearly tell are considered as negative points. If a patient has a history of lumbago and back pain, the operator should acquire the details of his or her medical history and perform a physical examination or imaging examination for further exclusion, to avoid making mistakes in the study results due to wrong positive points [10]. The positive points along the Du Meridian were selected for catgut embedment, together with Baihui (DU 20) and Dazhui (DU 14). If there were no positive response points, Zhiyang (DU 9), Lingtai (DU 10), Shendao (DU 11), Dazhui (DU 14), and Baihui (DU 20) would be used as the substitute. Operation process (Figure 1): after cleaning and disinfecting the hands of the operator and the patient’s fully exposed back, open the disposable bending plate, disposable embedding needle, absorbable protein thread, and metal tweezer and wear disposable sterile medical gloves. Then, pull out the embedding needle core about 2 cm and use the metal tweezer to place the protein thread into the needle tube from the needle tip. The operator held the embedding needle with one hand and lifted and pinched the skin on the back with the other hand to insert needles 0.1–0.3 inches from the acupoints selected at an angle of about 45° (between the needle body and the patient’s back). After that, slowly push the needle inward until it entered the interspinous ligament in the gap between the spinous processes, slightly deeper than the length of the protein thread. Then, pull it back slightly to the subcutaneous soft tissues and perform twirling, lifting, and thrusting methods until the local muscles had obvious soreness, numbness, heaviness, and distension. Afterwards, push the needle core while pulling back the needle tube to embed the protein thread into the subcutaneous soft tissues. For thread embedment in Baihui (DU 20), the needle was inserted into the subgaleal loose connective tissues at an angle of 15–30° (between the needle body and the scalp). The protein thread should not be exposed outside the epidermis. Every time before thread embedding, it is necessary to check whether there was a nodule around Baihui (DU 20) caused by incomplete absorption of protein thread. If it exists, Baihui (DU 20) will not be used for thread embedment [10]. After pulling out the needles, the operator should press the needle holes immediately with sterile cotton balls for 5–10 minutes, covering sterile dressing and fixed with adhesive tape for 24 hours. The patient could not take a shower within 24 hours. The method was performed once every two weeks for a total of 3 times (Day 0, Weeks 2 and 4). The observation indexes were evaluated before the first treatment (Day 0) and on the 6th week (Day 42) after the third treatment was finished.
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A 10-Year Follow-Up of a Randomized Prospective Study of 2 Treatments for Chronic Rhinosinusitis Without Nasal Polyps and Investigation of the Impact of Gastroeosophageal Reflux Disease in the Resistance to Treatment
Article
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Objectives: To compare the 2 long-term medical strategies in chronic rhinosinusitis without nasal polyps (CRSnNP) and to identify the role of gastroesophageal reflux disease (GERD) and Helicobacter pylori as factors of treatment failure. Material and methods: Fifty-seven patients with CRSnNP were randomized into 2 therapeutic groups. The first group was treated with 4 weeks of amoxicillin/clavulanate and a short course of oral steroids. The second group received 8 weeks of clarithromycin. Sinonasal Outcome Test-20 (SNOT-20) and Lund and Mackay scores were assessed at baseline and after treatment, and GERD Health-Related Quality of Life (GERD-HRQL) questionnaire was evaluated in all patients. Patients with a GERD-HRQL score >8 received esogastroscopy and H pylori detection. Patients were followed during a 10-year period for clinical course and GERD evolution. The 10-year evolution of patients was described in terms of recurrence, medical, and surgical treatments. Results: Thirty-seven patients completed the study; SNOT-20 and Lund and Mackay scores similarly improved in both groups. Amoxicillin/clavulanate group had significantly more adverse reactions than the clarithromycin group (P = .03). After the therapeutic course, 35% (amoxicillin/clavulanate) and 41% (clarithromycin) of patients needed functional endoscopic sinus surgery (FESS). During the long-term follow-up, 54% (amoxicillin/clavulanate) and 40% (clarithromycin) of patients had late CRSnNP recurrence; FESS was performed in less than 15% of cases of recurrence. Gastroesophageal reflux disease complaint's severity was associated with late recurrence of CRSnNP. Conclusion: Amoxicillin/clavulanate and clarithromycin would be competitive treatments for CRSnNP. Gastroesophageal reflux disease seems to be a negative factor for treatment response and recurrence.
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A phase III, multicenter, prospective, single-blinded, noninferiority, randomized controlled trial on the performance of a novel esophageal stent with an antireflux valve (with video)
Article
Full-text available
  • Jul 2019
  • GASTROINTEST ENDOSC
Background and aims: Self-expanding metal stents (SEMSs) when deployed across the gastroesophageal junction (GEJ) can lead to reflux with risks of aspiration. A SEMS with a tricuspid antireflux valve (SEMS-V) was designed to address this issue. The aim of this study was to evaluate the efficacy and safety of this stent. Methods: A phase III, multicenter, prospective, noninferiority, randomized controlled trial was conducted on patients with malignant dysphagia requiring SEMSs to be placed across the GEJ. Patients were randomized to receive SEMSs with no valve (SEMS-NV) or SEMS-V. Postdeployment dysphagia score at 2 weeks and Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) questionnaire score at 4 weeks were measured. Patients were followed for 24 weeks. Results: Sixty patients were randomized (SEMS-NV: 30 patients, mean age 67 ± 13 years; SEMS-V: 30 patients, mean age 65 ± 12 years). Baseline dysphagia scores (SEMS-NV, 2.5 ± .8; SEMS-V, 2.5 ± .8) and GERD-HRQL scores (SEMS-NV, 11.1 ± 8.2; SEMS-V, 12.8 ± 8.3) were similar. All SEMSs were successfully deployed. A similar proportion of patients in both arms improved from advanced dysphagia to moderate to no dysphagia (SEMS-NV, 71%; SEMS-V, 74%; 95% confidence interval, 1.93 [-17.8 to 21.7]). The dysphagia scores were also similar across all follow-up time points. Mean GERD-HRQL scores improved by 7.4 ± 10.2 points in the SEMS-V arm and by 5.2 ± 8.3 in the SEMS-NV group (P = .96). The GERD-HRQL scores were similar across all follow-up time points. Aspiration pneumonia occurred in 3.3% in the SEMS-NV arm and 6.9% in the SEMS-V arm (P = .61). Migration rates were similar (SEMS-NV, 33%; SEMS-V, 48%; P = .29). Two SEMS-V spontaneously fractured. There was no perforation, food impaction, or stent-related death in either group. Conclusions: The SEMS-V was equally effective in relieving dysphagia as compared with the SEMS-NV. Presence of the valve did not increase the risks of adverse events. GERD symptom scores were similar between the 2 stents, implying either that the valve was not effective or that all patients on proton pump inhibitors could have masked the symptoms of GERD. Studies with objective evaluations such as fluoroscopy and/or pH/impedance are recommended. (Clinical trial registration number: NCT02159898.).
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Gastroesophageal reflux disease prevalence among school teachers of Saudi Arabia and its impact on their daily life activities
Article
Full-text available
  • Apr 2017
Background Gastroesophageal reflux disease (GERD) is the most common upper gastrointestinal disorder encountered in the elderly patient. It is highly prevalent worldwide with a prevalence of 10-20% in the western world. The health-related quality of life (HRQL) is lower in individuals with GERD than in the general population and is comparable to that in individuals with other chronic diseases. It has a considerable impact on the quality of the patient’s life through its symptoms and economically by following consultation procedures and medical care. A few studies have been done in Saudi Arabia using general population as subject and have reported a very high prevalence. Objective (1) Estimation of gastro GERD prevalence among school teachers in Qassim region. (2) To assess the impact of GERD symptoms on teacher’s daily life activity. (3) To compare prevalence and risk factors of GERD between age-groups and gender. Methodology A cross-sectional study that was conducted among 200 school teachers selected by multi-stage stratified random sample method in Qassim region during 2015. A reliable and valid self-administered GERD questionnaire for diagnosis of GERD was used. GERD-HRQL questionnaire was used to assess the impact of GERD on the patient’s life quality. Data were analyzed using Statistical Package for Social Sciences Version 20.0; Chi-square was used to test the association between GERD and sociodemographic data. Results The total number of the participants was 200 with an equal male to female ratio. 55% (116/200) of the participants reported with GERD. 53 point 5% of these (62/116) were female and 46.6% (54/116) were male. The commonest age group was 31-40 years with 45.5% (91/200) participants. 13/200 (6.5%) participants were smokers, of which only 15.9% were female. 41 point 3% (48/116) of the GERD +ve participants were having blood group O +ve 7.8% (9/116) of GERD participants reported symptoms which affected their daily life activity. Conclusion This study revealed a prevalence of GERD symptoms among 58% of school teachers. 7 point 8% of GERD participants reported symptoms which affected their daily life activities. These data indicate a need for a comprehensive approach to managing the GERD and related diseases and a more intensified level of awareness about GERD symptoms and its complications. In addition, a health care and preventive measure may be implemented to tackle the problem among school teachers.
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Qualitative Evaluation of Osteopathic Manipulative Therapy in a Patient With Gastroesophageal Reflux Disease: A Brief Report
Article
Full-text available
  • Mar 2014
Gastroesophageal reflux disease (GERD) is a chronic condition that affects a growing number of people and is currently among the most common disorders seen in clinical practice. To develop a protocol for the management of GERD with osteopathic manipulative therapy (OMTh) applied to the diaphragm and esophagus, and to evaluate the protocol's effectiveness using the quality of life scale (QS-GERD) for the disease. In this single-blinded prospective study, an OMTh protocol focusing on the diaphragm and esophagus was applied to a single patient, who had received a diagnosis of GERD 4 years previously. Outcomes were measured using the QS-GERD, which has a total possible score ranging from 0 to 45 (the lower the score, the better the quality of life) and a level of satisfaction from very satisfied to incapacitated. The OMTh protocol was applied at 3 sessions (initial session, second session 1 week after the first, and third session 2 weeks after the second), and the patient completed the QS-GERD 4 times (before the first session, before the third session, and 2 and 4 weeks after the third session). The OMTh protocol was administered without adverse events, and the patient reported positive outcomes after the third session. The QS-GERD showed a score improvement from 13 of 45 to 4 of 45. The results in the present report show that OMTh applied to the diaphragm and esophagus may improve symptoms of GERD and should be added to the somatovisceral approach to the care of patients with this condition.
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[Symptom's questionnaire for gastroesophageal reflux disease]
Article
Full-text available
  • Dec 2004
  • Arq Gastroenterol
Structured questionnaires are valuable instruments to measure the impact of specific diseases in patient's quality of life through a score and they are available such abroad as in Brazil. Nevertheless, questionnaires based on gastroesophageal reflux disease symptoms are not available in Portuguese. To develop and validate in Portuguese a specific questionnaire for gastroesophageal reflux disease symptoms. Velanovich's original questionnaire was translated, one question about "regurgitation" symptom was included and the vocabulary was adjusted to be understood to the scholarity level of the analyzed population. The "face validity" to each question was evaluated by the members of a multidisciplinary panel and a symptom's questionnaire for gastroesophageal reflux disease was developed. The questionnaire was applied to patients with gastroesophageal reflux disease symptoms confirmed by prolonged pH esophageal monitoring. The reproducibility, the comprehension, the time spent to fill out the questionnaire and the correlation coefficient to Johnson-DeMeester's score were measured. The "face validity" was considered satisfactory by the panel and the questionnaire was applied to 124 patients, consecutively. The comprehension of the questionnaire and the time less than 5 minutes to fill out them were observed in all patients (100%). Reproducibility for 10 patients in two different occasions showed a high intra-class correlation coefficient of 0,833. The correlation to the Johnson-DeMeester's score was null. This study showed that the symptom's questionnaire for gastroesophageal reflux disease has "face validity", excellent reproducibility, easy comprehension and was quickly answered by patients. The correlation with Johnson-DeMeester's score was null.
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Gastroesophageal Reflux Disease - Health-Related Quality of Life Questionnaire: prospective development and validation in Italian
Article
  • Sep 2020
Objective: To date, two questionnaires investigating the symptoms of gastroesophageal reflux disease (GERD) (Quality of Life Reflux and Dyspepsia and Reflux Disease Questionnaire) are validated in Italian, but neither of the two questionnaires was correlated with an instrumental examination. The aim of the present study is to improve the GERD-Health Related Quality of Life (HRQL) questionnaire, to evaluate the reliability and validity of its Italian translation, and its sensitivity and specificity. Methods: A modified Italian GERD-HRQL (MI-GERD-HRQL) questionnaire was developed adding six questions investigating on regurgitation, for a total of 15 questions. The forward-backward translation process was employed to obtain a definitive from-English-to-Italian version. Data obtained from the questionnaire were compared to upper gastrointestinal endoscopy findings. Results: The questionnaire was administered twice to 130 Italian-speaking patients by two different and independent raters. Cronbach's α of the first and second questionnaire was 0.944 and 0.942, respectively. Spearman correlation and inter-rater reliability were 0.923 and 0.929, respectively. Sensitivity and specificity were 73.3 and 64%, and 69.5 and 64%, respectively, for the first and second questionnaire. Conclusion: The MI-GERD-HRQL questionnaire proved good consistency, reliability, sensitivity and specificity in the evaluation of typical GERD symptoms.
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Velanovich V, Vallance SR, Gusz JR, et al .Quality of life scale for gastroesophageal reflux disease
Article
  • Sep 1996
Treatment of uncomplicated gastroesophageal reflux disease (GERD) is primarily to improve the symptoms of the patient. However, measurement of symptomatic outcome is difficult because it is as the patient perceives it to be and not "objective." This creates a need to develop a simple and understandable instrument to measure symptomatic outcome. All patients referred for evaluation of GERD were eligible for this prospective study. During the initial visit, patients were asked to complete the Gastroesophageal Reflux Data Sheet. This ten-item questionnaire included an overall assessment of satisfaction; the best possible score was 0, and the worst was 45. The evaluation included history, physical examination, and additional studies, including upper gastrointestinal series, esophagogastroduodenoscopy, esophageal manometry, and 24-hour esophageal pH monitoring as indicated. Initial treatment was medical with histamine2-blockers, omeprazole, cisapride, or both. If a patient was dissatisfied with medical treatment and had both a hypotensive lower esophageal sphincter and abnormal results of the 24-hour pH monitoring, then operative treatment with either laparoscopic or open Nissen or Toupet fundoplication was offered. After approximately three months of medical treatment or one month after operative treatment, patients were asked to complete the questionnaire again. Data were analyzed using nonparametric tests and linear regression analysis. A total of 72 patients were assessed, and 100 percent of them completed the questionnaire. Patients who were satisfied with their condition had a median health-related quality of life (HRQL) score of five, and those who were dissatisfied had a median score of 26 (p < 0.000001). Patients who ultimately chose surgical therapy had a median preoperative score of 28, compared with 15 for patients who chose to continue medical therapy (p = 0.0001). The change in HRQL score from before treatment to after treatment for surgical patients was 27 compared with 11 for medically treated patients (p < 0.002). Items 1 through 6 of the questionnaire were individually sensitive to the effects of treatment. However, there was no correlation between HRQL and the composite pH score or with the lower esophageal sphincter pressure. This HRQL score has advantages over standard health status instruments for GERD including simplicity for patients (and therefore a high compliance rate), ease of understanding for physicians, and sensitivity to the effects of treatment. In addition, it may help determine, early in the course of treatment, patients who may ultimately require surgical therapy, thereby avoiding prolonged, but futile, medical therapy.
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