Hindi translation and validation of the English version of the gastrointestinal symptom rating scale questionnaire: An observational study

Abstract

BACKGROUND

The gastrointestinal symptom rating scale (GSRS) is a questionnaire in English language which is designed to assess the clinical symptoms in patients with irritable bowel syndrome (IBS) and peptic ulcer disease. This validated scale has questions on around 15 items and has been validated in patients with dyspepsia and IBS.

AIM

To translate and validate the English version of the GSRS questionnaire to the Hindi version.

METHODS

The purpose of the present work was to create a Hindi version of this questionnaire for use in the Indian population. The process involved various steps as per the World Health Organization methodology including initial forward translation, backward translation, and assessment by an expert committee. Initial pilot testing was followed by testing in healthy and diseased individuals.

RESULTS

The Hindi translation was pilot tested in 20 individuals and further validated in healthy controls (n = 30, 15 females) and diseased individuals (n = 72, 27 females). The diseased group included patients with functional dyspepsia and IBS. Cronbach's alpha for internal consistency on the final translated GSRS questionnaire was 0.715 which is considered adequate. Twelve questions significantly differentiated the diseased population from the healthy population (P value < 0.05) in the translated Hindi version of the GSRS.

CONCLUSION

The translated Hindi GSRS can be used to evaluate gastrointestinal function in clinical trials and community surveys in Hindi speaking populations.

Key Words: Irritable bowel syndrome; Gut health; Dyspepsia; Symptoms; Pain; Constipation; Diarrhoea

Core Tip: The gastrointestinal symptom rating scale is a validated 15 question scale used to assess overall gastrointestinal health and has been used in irritable bowel syndrome (IBS), dyspepsia and in multiple clinical trials. We translated this questionnaire into Hindi and validated it in patients with dyspepsia and IBS. The translation will allow this scale to be used in future studies in Hindi speaking populations.

INTRODUCTION

The gastrointestinal symptom rating scale (GSRS) is a questionnaire in the English language designed to assess the clinical symptoms in patients with irritable bowel syndrome (IBS) and peptic ulcer disease[1]. First reported in 1988, it has since been validated for the evaluation of clinical symptoms in patients with IBS and dyspepsia[2]. This validated scale has questions on around 15 items. The instrument has also been translated to multiple other languages[3]. The scale has been used in multiple clinical and research settings apart from IBS and dyspepsia, including overall gastrointestinal symptoms in diabetes, and general gastrointestinal symptoms[4]. Dyspepsia and IBS are common clinical problems that affect a large number of patients globally and have a significant mental health burden[5,6]. Therefore, the GSRS has immense value in clinical trials for these patients as it also assesses overall gastrointestinal symptoms.

The purpose of the present work was to create a Hindi version of this questionnaire for use in the Indian population. When translating a questionnaire initially established in a different nation and culture, the translation process must be able to cover all the necessary procedures to ensure that the validity and reliability of the questionnaire remain intact[7]. It is important to ensure that words in a health-related questionnaire translate accurately to the target language when translating it into a different language[8]. It is possible to decrease sample error, boost questionnaire response rates, and improve the generalizability of the results by assuring valid translation quality[9]. While the process of translating the questionnaire is included in the translation process, the process of validating the translated tool is mainly concerned with evaluating its quality[10]. The GSRS is the most relevant instrument for the evaluation of bowel function as it refers to the period in the previous week, requires a short time to complete and has easy-to-understand questions on gastrointestinal symptoms[3]. The World Health Organization (WHO) has created a standardised translation methodology in response to the growing requirement to ensure high-quality translations, particularly when it comes to cross-cultural research. Therefore, we have used the WHO-suggested methodology to create a Hindi translation of the GSRS[11].

MATERIALS AND METHODS

Study population

Ethical approval was obtained from the Institute Ethics Committee of the Postgraduate Institute of Medical Education and Research, Chandigarh (PGI/IEC-INT/2023/Study-977). All participants provided written informed consent prior to inclusion in the study.

GSRS

The GSRS is a self-administered questionnaire and has 15 items that cover the gastrointestinal system: Abdominal pain, diarrhoea, bloating, constipation, bowel movements, acidity, nausea, vomiting, abdominal rumbling, and eructation. GSRS questionnaire answers have been arranged in a 4-point Likert scale in which 0 represents no or transient and 3 represents severe symptoms[1]. The GSRS questionnaire is not copyrighted.

Forward and backward translation by an expert committee

The translation methodology was followed as suggested by the WHO including forward translation, expert panel back translation, pretesting and cognitive interviewing, and the final version[11]. The committee consisted of both the forward and backward translators, a methodologist (Padhi), and specialists with knowledge of the construct of interest. Members of the expert committee reviewed all versions of the translations and a prefinal version of the questionnaire was created.

Forward translation involved two investigators who were adept at both English and Hindi (Kumar and Sharma) who translated the questionnaire into Hindi. This translation of the questionnaire was assessed by experts fluent in both English and Hindi languages (Jearth and Sharma). They evaluated the cultural acceptability of the questionnaire for our population. After modifications to ensure cultural acceptability, the Hindi version was back-translated into English by an investigator not involved in the initial process (Jena). The back translation was compared to the original translation and modifications were made to ensure that the translation was appropriate to the original work.

Pretesting

Pretesting and cognitive interviewing were performed in 20 disease-free individuals (Figure 1). The purpose of this was to determine whether they could understand and correctly interpret the questionnaire. As they were all bilingual, they were also provided the English version so as to comment if the Hindi version captured the essence and meaning of the questionnaire. Debriefing was conducted regarding their experience with the questionnaire and if they could repeat the questions in their own words and how they chose an answer. Following this, a final version was created.

Figure 1  Flow chart showing the flow of the gastrointestinal symptom rating scale translation of the English version to Hindi and validation using the World Health Organization-suggested methodology.

Validation

Patients were enrolled in the outpatient department of gastroenterology. The final version was administered to dyspepsia patients and those with diarrhea-predominant IBS.

Inclusion criteria was based on ROME criteria for patients with dyspepsia and IBS. ROME IV criteria for functional dyspepsia were used which included the presence of one of the following symptoms: (1) Bothersome postprandial fullness; (2) Bothersome early satiation; (3) Bothersome epigastric pain; and (4) Bothersome epigastric burning and absence of any organic disease[12]. Similarly, the diagnosis of IBS was based on ROME IV criteria for IBS i.e. recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria: (1) Related to defecation; (2) Associated with a change in frequency of stool; and (3) Associated with a change in form (appearance) of stool[13]. The symptoms should have been present for six months and the criteria fulfilled over the past 3 months. Exclusion criteria included patients who denied consent and could not understand Hindi language, were illiterate, aged < 18 years or > 65 years.

Internal consistency

The degree of inter-correlation between the questions in the questionnaire and their consistency in measuring the same construct was indicated by internal consistency. The Cronbach's alpha coefficient, usually referred to as coefficient alpha, is frequently used to measure internal consistency[14]. Cronbach's alpha has a range of 0 to 1, with negative values occurring when there is a negative correlation between some questionnaire questions. Higher values indicate stronger interrelationships between the items, but if a negative Cronbach's alpha is still obtained after all items have been accurately scored, there are significant issues with the questionnaire's initial design. Internal consistency is absent when Cronbach's α = 0, while complete internal consistency is represented by α = 1. It has been recommended that an internal consistency of at least 0.70 on Cronbach's alpha scale be used in practice[15].

Test-retest reliability was not assessed as the scores were expected to change while on therapy which was initiated after the diagnosis.

Known group validity

Scores between the patients with IBS and dyspepsia were compared with controls to ascertain if the GSRS could differentiate the diseased participants from healthy participants.

Statistical analysis

The Statistical Package for the Social Sciences, 27^th version (SPSS-20, IBM) and R software version were used to analyse the data. Simple descriptive statistics involved the calculation of median and interquartile range (IQR) (or mean ± SD, depending on the normality of distribution as decided by the Kolmogorov-Smirnov test) for continuous variables and frequency along with percentages for the categorical variables. Cronbach’s alpha was used to assess the internal consistency of the Hindi version of the scale. The Mann-Whitney U test was used to compare the scores between the diseased participants and the controls.

RESULTS

Patients

A total of 117 individuals of both genders were included in the study. The group aged 16-70 years was administered the Hindi and English version of the GSRS in which 30 individuals were healthy controls (free of any known disease), 41 individuals were dyspepsia patients and 31 individuals had IBS (aged 21-66 years). Fifteen patients were excluded due to illiteracy (n = 14) and inability to understand Hindi language (n = 1). There was no disagreement or requirement for major vocabulary modifications as a result of the translation and back-translation processes (Table 1).

Table 1 Characteristics of the population included in the validation cohort, n (%).

	Healthy controls	Diseased group
		Functional dyspepsia	d-IBS
Number	30	41	31
Age (median, IQR) (years)	19-37 (25.5, 6.75)	16-70 (40,16.5)	21-66 (39,12.5)
Male gender	15 (50)	28 (68)	17 (55)
Duration of symptoms	Not applicable	Not applicable	Not applicable

d-IBS: Diarrhoea-predominant irritable bowel syndrome; IQR: Interquartile range.

Internal consistency was estimated by calculating Cronbach’s alpha which was 0.71 and considered adequate for the final version of the questionnaire.

Known group validity

The score for each of the questions (median and IQR) between the patients with IBS and dyspepsia (diseased group) were compared with healthy controls as shown in Table 2. Twelve questions in the questionnaire showed significant results (P value < 0.05); however, three questions (Q5, Q10, Q13) were not significant in this study, but can be evaluated for other diseases.

Table 2 Median, interquartile range, and P value of the questions of the final version of the Hindi translation in the diseased group and healthy group.

Question number	Diseased group (median, IQR)	Healthy group (median, IQR)	P value
Q1	1, 1	0, 1	0.02
Q2	1, 2	0, 1	0.02
Q3	1, 1	0, 1	0.04
Q4	1, 1	0, 0	0.002
Q5	0, 1	1, 1	0.66
Q6	1, 1	0, 1	0.0005
Q7	1, 2	0.5, 1	0.02
Q8	0.5, 1	0, 1	0.04
Q9	1, 2	0, 0	< 0.001
Q10	0, 0	0, 0	0.42
Q11	0, 1	0, 0	< 0.001
Q12	1, 1	0, 0	< 0.001
Q13	0, 1	0, 1	0.09
Q14	1, 1	0, 0	0.0002
Q15	1, 2	0, 0	< 0.001

IQR: Interquartile range.

DISCUSSION

In this work, we have translated and validated the Hindi translation of the GSRS. The GSRS is one of the most established, validated, reliable, and responsive disease-specific instruments available for assessing gastrointestinal symptoms. Language barrier is an important concern in the native language population limiting the application of such questionnaires beyond the population where the scale was created. There are multiple reasons why we chose to translate this questionnaire: The questionnaire provides information on the overall gastrointestinal health of an individual and can be used in community surveys to identify gastrointestinal health, it can guide the further line of questioning, and the GSRS has also been translated into multiple other languages. Therefore, the GSRS is an ideal questionnaire that can be used in global collaborative studies that assess gastrointestinal heath in various studies.

In this study, we translated the English version of the GSRS into the Hindi version and validated the translated scale in dyspepsia and IBS patients. We used the standard WHO-suggested methodology to create the Hindi translation[11]. The GSRS has previously been translated and validated in the Brazilian Portuguese language for the assessment of bowel function with appropriate consistency[3]. In addition, translation into Hungarian and German languages has also been conducted[16,17]. Hindi is amongst the top five most frequently spoken languages in the world and therefore this translation of the GSRS is likely to help in research amongst a large subset of the global population.

Apart from the use of standard methodology including lingual and subject experts in the translation, the translation also demonstrates excellent internal consistency. The correlation between the questions was found to be adequate i.e. Cronbach’s alpha was 0.71. There were twelve questions with significantly different responses in the diseased group (P value < 0.05). Nonetheless, three items (Q5, Q10, Q13) can be examined for different illnesses as they are not significant in this study (Table 2). Furthermore, the questions also identified the diseased population from the healthy population, suggesting the usefulness of the scale in field/community surveys. The Hindi translated version of the GSRS is therefore useful in an Indian population for the assessment of dyspepsia and IBS by clinicians. In spite of these strengths, the study has some limitations: This is a single centre study, the diseased population included only patients with dyspepsia and IBS and we could not perform test-retest reliability. Nevertheless, future studies in larger datasets would clarify the utility of this translation in various other clinical and community settings.

CONCLUSION

In conclusion, a culturally appropriate Hindi translation of the GSRS with suitable internal consistency and reliability has been created.