Development and validation of Hebrew version of the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract Instrument 2.0

Abstract

Aim:

The aim of this study was to test the reliability of the University of California, Los Angeles Scleroderma Clinical Trial Consortium Gastrointestinal Tract (UCLA SCTC GIT) 2.0 questionnaire in Hebrew.

Methods:

UCLA SCTC GIT 2.0 was translated into Hebrew using the translation–retranslation method. The Hebrew version of the UCLA SCTC GIT 2.0 and the Hebrew version of the Short Form 36 (SF-36) were administered to 19 Hebrew-speaking patients with systemic sclerosis. Internal reliability was assessed using Cronbach’s alpha. The Hebrew questionnaire was then tested for external validity using Spearman’s correlation coefficient. Correlations (rho) ⩽ 0.29 were considered small, 0.30 to 0.49 were moderate, and those ⩾0.50 were considered large. Differences were considered statistically significant at p < 0.05.

Results:

A group of 19 patients treated at Sheba Medical Center meeting the ACR/EULAR classification system for systemic sclerosis were included in the study. The mean age of the participants was 60.4 ± 12 years with a female predominance (84%). Diffuse cutaneous scleroderma accounted for 10 of the participants (54%), 7 had limited cutaneous scleroderma (36%) with 2 having an overlap syndrome (10%). The Cronbach’s alpha value for the UCLA SCTC GIT 2.0 scale was 0.908 showing reliability. In addition, the UCLA SCTC GIT 2.0 showed correlation to the SF-36.

Conclusion:

The translation of the Hebrew UCLA SCTC GIT 2.0 scale was reliable and valid with a total Cronbach’s alpha score among the participants of 0.908. Cronbach’s alpha was particularly reliable in reflux, bloating, social function, and emotional well-being. Our results suggest that our Hebrew version of the UCLA SCTC GIT 2.0 scale can be used as a tool in future studies with Hebrew-speaking patients. In the abstract conclusion, it states that “Cronbach’s alpha was particularly reliable in reflux, bloating, social function, and emotional well-being.” The related data should be listed in the results section and then an interpretation of the results should be listed in the conclusions section. Please revise.

Key points

Gastrointestinal manifestations are both frequent and clinically significant in scleroderma.

The UCLA SCTC GIT 2.0 scale is a tool that can be used to measure the degree of gastrointestinal morbidity associated with scleroderma.

The UCLA SCTC GIT 2.0 scale is reliable in Hebrew.

Introduction

Systemic sclerosis (SSc) is an autoimmune condition that leads to fibrosis of skin and internal organs. Gastrointestinal involvement occurs in almost 90% of SSc patients, leading to significant morbidity and to negative impact on quality of life. ¹

The UCLA SCTC GIT 2.0 is a validated tool developed by Khanna et al. ² for assessing gastrointestinal symptoms in SSc. The questionnaire is comprised of 34 questions spanning seven categories: reflux, distension, diarrhea, fecal incontinence, constipation, emotional well-being, and social functioning. The tool uses a composite score that is intended to measure the severity of gastrointestinal symptoms in patients with SSc. ³ This tool was originally validated in English and since has been translated to several other languages.^4–9

The purpose of this study was to translate the UCLA SCTC GIT 2.0 questionnaire to Hebrew and test the translations reliability and validity.

Methods

In order to produce a Hebrew version of the UCLA SCTC GIT 2.0 instrument in Hebrew, forward and back translations of the tool were performed. Translation and cross-cultural adaptation of the instrument were performed according to the published recommendations. ¹⁰ Two bilingual translators conducted independent English to Hebrew forward translations of the instrument followed by consolidation of their translations into one version. This was followed by back translation to English by an independent native English-speaking bilingual translator. The English back translation was then compared to the UCLA SCTC GIT 2.0 for confirmation.

We recruited adult patients diagnosed as having SSc, referred to the rheumatology department at Sheba Tel Hashomer Medical Center. Patients were included after obtaining written informed consent. The study was approved by the Helsinki committee at Sheba Tel Hashomer Medical Center. Inclusion criteria were adult patients fulfilling SSc ACR/EULAR 2013 criteria that were Hebrew speaking. 37 consecutive patients referred to Sheba Tel Hashomer Medical Center were contacted, and 19 agreed to participate.

The participants were administered the Hebrew version of the UCLA SCTC GIT 2.0 with the Hebrew version of the SF-36 version 1. A total of 19 patients completed the survey and were included in the analysis. Internal reliability was assessed using Cronbach’s alpha. The Hebrew questionnaire was then tested for external validity by comparing the instrument to the SF-36 questionnaire using Spearman’s correlation coefficient. Correlations (rho) ⩽ 0.29 were considered small, 0.30 to 0.49 were moderate, and those ⩾0.50 were considered large. Differences were considered statistically significant at p < 0.05.

Results

The characteristics of the study group patients had a mean age was 60.4, were predominantly female (84%) and were sick for an average of 9 years (Table 1). There were slightly more patients with diffuse cutaneous SSc in our cohort (54%).

Table 1.

Characteristics of study participants.

Age, years (SD)	60.4 (12.5)
Female, %	84
Mean weight, kg (SD)	64 (13)
Disease duration years (SD)	9 (7.8)
Systemic sclerosis type
Diffuse cutaneous, %	54
Limited cutaneous, %	36
Overlap, %	10

SD: standard deviation.

Cronbach’s alpha above 0.6 is indicative of internal consistency within an instrument. In our cohort, the mean total GIT score was 0.5 with a Cronbach’s alpha of 0.9. When the domains comprising the total GIT score were looked at individually the Cronbach’s alpha score remained elevated in all domains except for diarrhea (Table 2). Cronbach’s alpha was particularly reliable in reflux, bloating, social function, and emotional well-being with scores of 0.8, 0.7, 0.8, and 0.9 respectively.

Table 2.

Descriptive statistics and consistency reliability of the UCLA SCTC GIT 2.0 Hebrew version.

UCLA SCTC GIT (n = 19)	No. of items	Mean	SD	Min	Max	Floor effect, %	Ceiling effect, %	Cronbach’s ɑ
Reflux	8	0.789	0.338	0.000	2.375	63.2	17.8	0.84
Bloating (distention?)	4	1.039	0.173	0.000	2.750	53.9	23.7	0.746
Fecal soilage	1	0.421	1.017	0.000	3.000	84.2	10.5	NA
Diarrhea	2	0.421	0.298	0.000	1.500	68.4	13.2	0.287
Social function	6	0.219	0.045	0.000	1.666	87.7	2.6	0.836
Emotional well-being	9	0.494	0.155	0.000	2.666	77.1	14.7	0.921
Constipation	4	0.303	0.077	0.000	0.750	72.4	6.6	0.663
Total GIT score (excluding constipation)	30	0.501	0.384	0.000	1.306	5.3	0.0	0.908

UCLA SCTC GIT: University of California, Los Angeles Scleroderma Clinical Trial Consortium Gastrointestinal Tract; SD: standard deviation; NA: not applicable.

Spearman’s correlation coefficient confirmed the external validity of the UCLA GIT 2.0 Hebrew translation. There was statistically significant correlation between the total GIT score and the SF-36 domains besides for pain and emotional well-being (Table 3). Overall, the GIT score was moderately correlated with the SF-36.

Table 3.

Spearman’s correlation between UCLA GIT 2.0 Hebrew version and SF-36 scale.

Spearman’s correlation
	reflux		bloating		soilage		diarrhea		social		emotional		constipation		GIT total
	rho	p-value	rho	p-value	rho	p-value	rho	p-value	rho	p-value	rho	p-value	rho	p-value	rho	p-value
Physical function	−.671**	0.002	−0.292	0.224	0.215	0.376	−0.145	0.554	−0.010	0.968	−0.186	0.447	0.057	0.818	−.499*	0.030
Role limitations due to physical health	−.595**	0.007	−0.299	0.213	−0.122	0.620	0.032	0.897	0.042	0.864	−0.335	0.160	−0.004	0.986	−0.412	0.079
Role limitations due to emotional problems	−0.178	0.467	−.465*	0.045	−0.140	0.568	0.102	0.676	−0.342	0.152	−.529*	0.020	−.615**	0.005	−0.399	0.091
Energy/fatigue	−.506*	0.027	−0.396	0.093	−0.128	0.602	0.101	0.679	−.470*	0.042	−.698**	0.001	−0.334	0.162	−.595**	0.007
Emotional well-being	−0.285	0.236	−0.111	0.650	−0.187	0.443	0.190	0.436	−.499*	0.030	−.636**	0.003	−0.372	0.116	−0.372	0.116
Social functioning	−0.296	0.218	−0.231	0.342	−0.097	0.691	−0.023	0.925	−.577**	0.010	−.642**	0.003	−.612**	0.005	−.537*	0.018
Pain	−0.373	0.116	0.044	0.857	−0.282	0.242	0.357	0.134	−0.215	0.376	−0.439	0.060	−0.116	0.637	−0.183	0.454
General health	−.575**	0.010	−0.183	0.453	−0.053	0.828	−0.096	0.696	−0.317	0.185	−.487*	0.035	−0.178	0.467	−.549*	0.015

GIT: gastrointestinal tract.

^*Correlation is significant at the 0.05 level (two-tailed).

^**Correlation is significant at the 0.01 level (two-tailed).

Discussion

The English version of the UCLA SCTC GIT 2.0 has been validated and has been adopted by several other countries. ³ It is already being implemented in clinical trials in order and is already being used in the United States and Canada for the purpose of clinical trials and has been adapted for use in a number of European countries.

In this study, we translated the UCLA SCTC GIT 2.0 to Hebrew. This is the first Hebrew adaptation of the questionnaire. Cronbach’s alpha testing and Spearman’s coefficient suggest that the Hebrew questionnaire is reliable and valid when compared to the SF-36. The original English version of the UCLA-GIT 2.0 had satisfactory reliability and validity, we found this to be true as well when translated to Hebrew.

The UCLA SCTC GIT 2.0 was previously translated to other languages including French, Italian and Korean.^5,7,11 In comparison to the Italian and French studies, our cohort was notably smaller. This likely contributed to our inability to show reliability in the diarrhea domain. However, the UCLA SCTC GIT 2.0 was designed to combine the seven domains to produce an aggregate score, and this score remained reliable in Hebrew despite the small cohort.

Our cohort was comparable to previous scleroderma studies in being predominantly female. The average age of the participants in our study was 60 with a disease duration of 9 years. This was like the French, Italian and Korean cohorts who all had predominantly female participants in their fifth and sixth decade. Although the French and Italian participants were diagnosed with SSc a decade before participating in the study, the Korean participants were only diagnosed 2 years before participation on average.

In addition, our study showed a correlation between the UCLA SCTC GIT 2.0 and the SF-36 like previous translations. In our cohort, the UCLA SCTC GIT 2.0 was moderately correlated (rho between 0.3 and 0.49) with emotional well-being, energy/fatigue and physical function domains of the SF-36 and highly correlated (rho ⩾ 5) for the general health domain.

The limitations of our study are the small size of our cohort, the nature of the participants all belonging to a single center, the specific nature of patients that were willing participants in a questionnaire study and the participants being primarily female. However, the goal of this study was never to compare the characteristics of the patients, rather to test the reliability of the Hebrew adaptation of the UCLA SCTC GIT 2.0. Therefore, despite the limitations we have shown that the Hebrew translation of the UCLA SCTC GIT 2.0 performs reliably and can be used in future studies in Israel for Hebrew-speaking patients.

Conclusion

In conclusion, we found the Hebrew version of the UCLA SCTC GIT 2.0 to be a reliable and valid instrument, useful to assess gastrointestinal symptoms in Hebrew-speaking patients with SSc.