Article Text

Validity and reliability of the Persian version of the Gastroesophageal Reflux Disease Health-Related Quality of Life questionnaire
  1. Seyed Ali Ebrahimi1,
  2. Zahra Mostafavian2,
  3. Elahe Karazhian3,
  4. Fereshteh Najafi4,
  5. Rasam Mashoufi1,
  6. Tooraj Zandbaf5,
  7. Elham Mokhtari6
  1. 1Medical Sciences, Islamic Azad University, Mashhad, Iran
  2. 2Department of Community Medicine, Islamic Azad University, Mashhad, Iran
  3. 3Department of Medical-Surgical Nursing, Mashhad University of Medical Sciences, Mashhad, Iran
  4. 4Tehran University of Medical Sciences, Tehran, Iran
  5. 5Department of General Surgery, Islamic Azad University, Mashhad, Iran
  6. 6Department of Internal Medicine, Islamic Azad University, Mashhad, Iran
  1. Correspondence to Dr Elham Mokhtari; emokhtaria{at}gmail.com

Abstract

Objective The Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) is one of the most widely used questionnaires for assessing typical gastro-oesophageal reflux disease (GORD) symptoms. It is simple, concise, and treatment responsive, yet it has not been validated in the Persian language. This study aimed to translate the GERD-HRQL questionnaire into Persian and assess its validity and reliability.

Design In this cross-sectional validation study, a team of gastroenterologists, general surgeons, and professional translators conducted the forward-backward translation. A gastroenterologist interviewed 10 patients with GORD to insure understandability of the questionnaire. Fifty-four patients with GORD and 60 patients with gastrointestinal complaints other than GORD were enrolled using convenience sampling method. To assess concurrent validity, patients with GORD completed the Persian GERD-HRQL and the WHO Quality of Life Brief Version (WHOQOL-BREF) questionnaires. To assess discriminant validity, GERD-HRQL scores were compared between GORD and non-GORD patients. After 2 weeks, the patients with GORD completed the GERD-HRQL questionnaire again to assess test–retest reliability. The internal consistency was measured using Cronbach’s alpha.

Results The mean age of the GORD participants was 36.90±10.44, and the majority were women (78%). All GERD-HRQL domains and total scores exhibited significant negative correlations with WHOQOL-BREF domains (ranging from −0.28 to −0.97). The GERD-HRQL scores were significantly different in GORD and non-GORD patients (p<0.001). Test and retest scores did not show any significant differences (p=0.49). Cronbach’s alpha was 0.85.

Conclusion The Persian GERD-HRQL questionnaire is valid and reliable and can effectively assess the GORD symptoms in Persian-speaking individuals.

  • GASTROESOPHAGEAL REFLUX DISEASE
  • OESOPHAGEAL REFLUX
  • QUALITY OF LIFE

Data availability statement

Data are available upon reasonable request. Unnamed patient data are available upon request.

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WHAT IS ALREADY KNOWN ON THIS TOPIC

  • Gastro-oesophageal reflux disease (GORD) is a prevalent health concern with a substantial impact on individuals’ quality of life.

  • There is a notable scarcity of validated questionnaires in Persian for assessing GORD, hindering research and patient care.

  • The Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) questionnaire is a widely used, practical, and user-friendly questionnaire for measuring the quality of life, response to treatment, and severity of GORD.

WHAT THIS STUDY ADDS

  • There is no available Persian version of the GERD-HRQL questionnaire.

  • We translated and evaluated the psychometric properties of the questionnaire in Persian.

  • This study further supports the GERD-HRQL questionnaire as a valid and reliable tool for assessing GORD-related quality of life.

HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY

  • Researchers and clinicians can now use the Persian GERD-HRQL questionnaire in their research and clinical practice to effectively evaluate GORD symptoms and its impact on the quality of life in Persian-speaking patients.

Introduction

Gastro-oesophageal reflux disease (GORD) is a clinical condition characterised by symptoms and complications resulting from the backflow of stomach contents into the oesophagus.1 Some of the most significant risk factors for GORD include obesity, hiatal hernia, pregnancy, smoking, and the use of certain medications. Symptoms may manifest as heartburn, regurgitation, dysphagia, odynophagia, dental erosion, non-cardiac chest pain, and extraoesophageal symptoms such as chronic cough, hoarseness of voice, reflux-induced laryngitis, and exacerbation of asthma. If left untreated, complications such as oesophagitis, oesophageal stricture, Barrett’s oesophagus, and even upper gastrointestinal bleeding can develop.2

GORD is a highly prevalent disorder worldwide, with an estimated occurrence of 18–28% in North America.3 Approximately half of all adults will experience reflux symptoms at some point in their lives.4 A recent systematic review published in 2020 reported that the prevalence of GORD in Iran is as high as 43%, highlighting the substantial burden of this condition on the Iranian population and underscoring the necessity for further research on its risk factors and treatments.5 Effective treatment of GORD has been shown to significantly improve patient quality of life by reducing pain, enhancing physical and social functioning, and promoting an overall sense of well-being.6

With the advent of antireflux surgeries and the growing need for an effective tool to assess typical GORD symptoms, Velanovich developed the Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) instrument in 1996.7 Since then, the GERD-HRQL has been among the most widely used tools for evaluating symptom severity, quality of life, and response to treatment in patients with GORD. This questionnaire is easy to understand and complete, requiring just 1 min to complete the original 11-item version.8 GERD-HRQL is endorsed by the European Society of Endoscopic Surgery.9 Furthermore, the US Food and Drug Administration has released industry guidance listing GERD-HRQL as a good ‘primary effectiveness endpoint’ for medical device clearance submissions related to GORD treatments.10

There are currently few validated Persian instruments available for assessing GORD symptoms, and the majority of these instruments are challenging to obtain.11 The lack of appropriate measurement tools hinders the progress of GORD research.

The GERD-HRQL has been translated and validated in various languages across the world, but a Persian version of this valuable questionnaire is unavailable.7 In this study, we aimed to translate the GERD-HRQL into Persian and evaluate its validity and reliability.

Methods

Participants

This cross-sectional validation study was conducted in the gastroenterology clinic of the Aria Academic Hospital in Mashhad, Iran. Participants were recruited through non-random convenience sampling. All patients were interviewed and examined by a single gastroenterologist. Eventually, 54 patients with GORD met the inclusion criteria. Literate patients over 18 years old, presenting with GORD symptoms, without any alarming signs of complicating disorders or conditions severe enough to necessitate urgent medical treatment, were included. In addition, to assess discriminant validity, we recruited a group of 60 patients with gastrointestinal complaints unrelated to GORD (non-GORD group). This group was matched with the patients with GORD in terms of age and gender. To assess the adequacy of the sample size, the study’s power was calculated and determined to be 0.92.

Description of GERD-HRQL

The GERD-HRQL questionnaire comprises 11 items that focus on various aspects of GORD symptoms over a 2-week recall period. The first six items assess heartburn symptoms; items 7 and 8 address dysphagia; item 9 focuses on bloating; item 10 assesses the effects of taking medications; and the final item assesses the patient’s satisfaction with their current health condition. A modified version of the questionnaire was later introduced, which added six questions regarding regurgitation symptoms (items 10–15) and omitted the bloating item.12 13 Since regurgitation is an important symptom of GORD, we evaluated the modified version of the questionnaire. Each item is scored on a scale of 0–5, with a higher score indicating a worse quality of life. The best possible total GERD-HRQL score is 0 (asymptomatic in all items), and the worst possible score is 75 (incapacitated in all items).

Translation and linguistic validation

The linguistic validation of the GERD-HRQL into Persian aimed to achieve a conceptually equivalent and comprehensible version of the questionnaire (online supplemental file 1). Forward Persian translation was carried out by five translators, including two gastroenterologists, two surgeons, and a professional English translator. Back translation to English was performed by two experienced professional translators, and any discrepancies were discussed and resolved. Based on previous experience of the translation team and observations of Nasseri-Moghaddam et al in their study validating the Persian version of the Mayo Gastro-Esophageal Reflux Questionnaire (GERQ), the translation team decided to include brief descriptions of regurgitation and heartburn.11 This was because the Persian equivalents of these words (pronounced ‘t-o-rsh k-a-rd-a-n’ and ‘s-u-ze-sh s-a-re-d-e-l’, respectively) are used interchangeably and non-specifically in Persian, potentially causing confusion among patients. Consequently, we added the following explanation: ‘Heartburn is the burning pain or discomfort behind the sternum/midchest, and regurgitation is the return or so-called ‘regurgitating’ of stomach contents to the mouth and the sensation of an acidic or bitter taste in the mouth’. Finally, 10 subjects were asked to complete the questionnaire and provide feedback regarding any ambiguities or difficulties through open interviews with a gastroenterologist; however, no significant issues were noted.

Validity

After establishing the final Persian questionnaire, we evaluated its reliability and validity. In the initial visit, patients completed the GERD-HRQL questionnaire and the 26-question WHO Quality of Life Brief Version (WHOQOL-BREF) questionnaire to assess concurrent validity. The WHOQOL-BREF is a 26-question questionnaire that measures an individual’s overall quality of life. It consists of four subscales: physical health, mental health, social relationships, and environmental health, with higher scores indicating a higher quality of life. In Iran, Nejat et al translated this scale into Persian and reported its validity and reliability.14 Moreover, the non-GORD group completed the GERD-HRQL in order to assess discriminant validity.

Reliability

To assess the reproducibility of the questionnaire, we employed a test–retest approach. After the initial visit, patients were asked to return 2 weeks later. To minimise potential bias in their responses, patients were kept unaware of the intended retest during the next visit. No medical treatment was recommended during this 2-week period, except for lifestyle modifications. Furthermore, the internal consistency of the questionnaire was evaluated using Cronbach’s alpha.

Statistical analysis

Mean and SD, as well as median and IQR, were used to describe the data. A paired t-test was used to check the differences in the test–retest mean. Pearson’s correlation coefficient (r) was used to determine the correlation between quantitative variables. Cronbach’s alpha coefficient was also reported to determine the variance of the questionnaire and its domains. A p value of less than 5% was considered statistically significant.

Results

The back translation closely mirrored the original sentences, confirming the accuracy of the translation. 10 patients completed the questionnaire and were subsequently interviewed by a gastroenterologist. The interviews proceeded smoothly, and no ambiguities were reported by the patients.

Table 1 shows the demographic characteristics of the participants. Fifty-four GORD and 60 non-GORD patients were entered into the study. The mean age of the patients with GORD was 36.90±10.44 years, and 42 of them were women (77.78%). Similarly, the mean age of the non-GORD patients was 36.36±8.15 years, and 46 of them were women (76.66%). The mean GERD-HRQL completion time was 6.45±2.05 min.

Table 1

Demographic characteristics of the participants

As summarised in table 2, the questionnaire’s mean and median total scores, as well as the heartburn and regurgitation subscales, did not show any difference in test–retest. The mean total score was 14.15±8.48 during the test phase and 13.74±7.61 during the retest phase. These results indicate no significant difference and confirm test–retest reliability. Cronbach’s alpha of the GERD-HRQL was 0.845, indicating excellent internal consistency.

Table 2

Results of test–retest reliability of the Persian GERD-HRQL

To establish the concurrent validity of the Persian GERD-HRQL questionnaire, a comparative analysis was conducted using the WHOQOL-BREF questionnaire (table 3). Notably, all the subscales and the total score in the Persian GERD-HRQL questionnaire demonstrated a significant inverse correlation with the subscales and total scores in the WHOQOL-BREF questionnaire. The weakest correlation was observed between environmental health and heartburn (r=−0.28). In contrast, the strongest correlation was found between physical health and the total score in the Persian GERD-HRQL questionnaire (r=−0.97).

Table 3

Correlation between the WHOQOL-BREF and the Persian GERD-HRQL

The mean GERD-HRQL scores in GORD and non-GORD patients are summarised in table 4. Discriminative validity analysis showed that the differences in GERD-HRQL’s total, heartburn, and regurgitation scores were statistically significant between the two groups (all p<0.001).

Table 4

GERD-HRQL scores in GORD and non-GORD patients

Discussion

The primary objective of our study was to develop a Persian version of the GERD-HRQL questionnaire and evaluate its validity and reliability. Our findings affirm the robust validity and reliability of the Persian adaptation of the GERD-HRQL questionnaire. Patient scores remained consistent in the test–retest assessments, reflecting their perceived symptoms. Cronbach’s alpha was 0.845, confirming excellent internal consistency. Concurrent validity was confirmed by significant correlations between GERD-HRQL and the WHOQOL-BREF questionnaire (ranging from −0.28 to −0.97). These consistent correlations across all domains emphasise the effectiveness of the GERD-HRQL questionnaire in accurately assessing the health-related quality of life of patients with GORD. Despite non-GORD patients experiencing gastrointestinal symptoms, the GERD-HRQL demonstrated a remarkable ability to discriminate among their symptoms.

The GERD-HRQL questionnaire was developed in 1997 by Dr Vic Velanovich to address the need for a standardised instrument to quantitatively measure symptom severity in GORD.7 Since its development, the validity, reliability, responsiveness, and practicality of the GERD-HRQL have been extensively tested and evaluated using various methods.8

The questionnaire has been translated and validated in several different languages. It has been compared with physiological measures such as endoscopic grading of oesophagitis, oesophageal manometry, and 24-hour pH monitoring. The GERD-HRQL has also been compared with the 36-Item Short Form Health Survey (SF-36) quality of life questionnaire and the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire .8 There has been an increase in usage of GERD-HRQL in recent years. Recently, Velanovich conducted a comprehensive review that analysed 25 years of real-world usage of GERD-HRQL. A total of 767 articles were identified that cited or used the GERD-HRQL. It was predominantly used in surgical studies (416 articles) but also found applications in assessing patient experience, pathophysiological studies, complementary medicine studies, and diagnostic tests. The GERD-HRQL has been employed in 46 randomised controlled trials, indicating confidence in its sensitivity to measure changes in symptom severity by treatment. The instrument served diverse purposes, with the most common being the assessment of treatment effects (368 articles).15 However, it was also used to categorise patients into symptom severity groups, set inclusion criteria, and measure symptom severity in specific patient groups.16 However, the selection of this questionnaire for clinical trials should be made in accordance with the specific outcome measures desired. In a study by Allotey et al, GERD-HRQL scores were compared with preoperative oesophagogastroduodenoscopy findings. The results indicated that the GERD-HRQL questionnaire is a limited indicator of oesophagitis or its severity in patients undergoing assessments for bariatric surgery.17 Hence, the choice to employ the GERD-HRQL questionnaire, either independently or in combination with other measures, should be determined based on the clinical rationale.

Regretfully, the validated Persian version of the questionnaire has not been available to date. We used a modified version of the questionnaire, which incorporated an additional six questions related to regurgitation symptoms. Regurgitation is a significant and characteristic symptom of GORD, and its inclusion in the questionnaire enhances its effectiveness in evaluating treatment responses. This modified version of GERD-HRQL (modified Italian GERD-HRQL) was developed and subsequently validated in a study involving 130 patients with GORD with a Cronbach’s alpha of 0.94 and Spearman correlations of 0.92.12 This version of the questionnaire has been extensively used in research, especially in assessing postoperative symptoms and responses to surgical treatments.9 13 18

In prior research conducted in Russia using the 11-item version of the GERD-HRQL questionnaire, face validity scores ranged from 0.92 to 0.97.19

One of the notable strengths of the GERD-HRQL questionnaire is its practicality. It consists of a concise set of questions that minimise the time needed from patients, rendering it a user-friendly tool. In this context, our participants, on average, completed the questionnaire in just 6 min.8

A recent systematic review and meta-analysis revealed that the prevalence of GORD symptoms in Iran is as high as 43.07%.5 Surprisingly, Persian questionnaires assessing GORD symptoms are scarce. According to our search of the online databases, only three validated Persian patient-reported outcome measures investigating symptoms of GORD are available: the Quality of Life in Reflux and Dyspepsia (QOLRAD) Questionnaire, the Mayo-GERQ, and the Reflux Symptom Score-12 (RSS-12).11 20 21

The Mayo-GERQ is a comprehensive questionnaire with 80 questions assessing typical and atypical symptoms of GORD.11 However, it has shortcomings. It is quite long, taking 16 min to complete. The questionnaire has coloured pages to simplify skipping certain questions, which makes spreading it difficult. It should be mentioned that the validation study was carried out on hospital staff, which may limit its generalisability.

QOLRAD assesses GORD and dyspepsia symptoms. QOLRAD demonstrated good concurrent validity with SF-36 domains. The validation study was somewhat limited by the small sample size of 50 patients for initial testing and only 22 for retesting.20 QOLRAD provides a broader view of the patient’s quality of life, encompassing multiple upper gastrointestinal symptoms. On the other hand, GERD-HRQL, as the name suggests, focuses on GORD symptoms.

The RSS-12 questionnaire is simple and straightforward. However, the RSS-12 mainly measures laryngopharyngeal reflux symptoms and their associated complications, and heartburn is only assessed through one item. The RSS-12 showed excellent convergent validity through a high correlation with the Reflux Symptom Index (RSI).21 However, it is unclear how the RSI has been used to validate the RSS-12, as the RSI, as far as we have searched, is not validated in Persian.

The GERD-HRQL questionnaire also has shortcomings. It primarily addresses standard GORD symptoms and falls short in evaluating atypical GORD symptoms. It does not encompass respiratory or laryngeal symptoms or separate chest discomfort as a distinct symptom from heartburn. Similarly, it does not adequately assess the impact of GORD on patients’ lifestyles or daily activities, whereas other tools are better suited for this purpose.8 22

In summary, the Persian adaptation of the GERD-HRQL questionnaire has been successfully validated in our study and is highly recommended for use in research conducted in Iran. Our investigation has unequivocally established its reliability, validity, and practicality for the specific purpose of assessing GORD-related quality of life. Future research initiatives should prioritise conducting additional comparative analyses with alternative assessment tools.

Data availability statement

Data are available upon reasonable request. Unnamed patient data are available upon request.

Ethics statements

Patient consent for publication

Ethics approval

This research was nested in a study approved by the ethics committee of Mashhad Islamic Azad University of Medical Sciences, a member of the National Ethics Committee (registration number: IR.MUMS.REC.1401.014). Informed consent forms were completed by all participants, and participants did not incur any costs for visits.

Acknowledgments

We are most grateful to Dr Vic Velanovich for granting permission to translate and validate GERD-HRQL. We also thank our participants who patiently provided us with the information.

References

Supplementary materials

  • Supplementary Data

    This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

Footnotes

  • Contributors EM and TZ provided the idea of the study and supervised the study. Study was planned and designed by SAE, ZM, EM, TZ and FN. SAE, EM and TZ led the translation team. The translation team are not fully listed as authors; however, EK and RM contributed to translation. EM provided and interviewed the clinic patients and SAE, EK and RM collected the data. FN and ZM analysed the data and drafted the results. Manuscript was written by SAE, EK, FN and RM and reviewed and edited by the rest of the team. EM and TZ are responsible for the overall content of the study as guarantors.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.