Translation and Validation of Urticaria Control Test (UCT) and Chronic Urticaria Quality of Life (CU-Q2oL) Questionnaires in Hindi

Abstract

Introduction:

Chronic urticaria (CU) is a distressing skin condition characterised by pruritic wheals, with or without angioedema, lasting for more than 6 weeks. The disease significantly compromises patients’ quality of life, affecting various aspects of daily living. Assessing disease control and quality of life in CU patients is essential for evaluating disease burden and improving therapeutic outcomes. However, there is a lack of tools to assess these parameters in the Hindi-speaking population in India. This study aims to translate, adapt, and validate the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) and Urticaria Control Test (UCT) in Hindi, providing culturally relevant and accurate assessments.

Methods:

The translation process followed standard procedures, including forward and backward translations, expert committee review, and preliminary pilot testing. The reliability and validity of the translated questionnaires were evaluated. Internal consistency, test-retest reliability, and inter-rater reliability were assessed for both CU-Q2oL and UCT. Construct validity was determined by comparing CU-Q2oL and UCT with an established English Dermatology Life Quality Index (DLQI) score. A cross-sectional study recruited 30 adult patients with CU from an Indian tertiary care hospital. Demographic details and disease parameters were collected, and participants filled the questionnaires at baseline and after 14 days.

Results:

The mean age of the participants was 37.86 ± 11.69 years, and most were female (63.3%). The Hindi version of CU-Q2oL demonstrated respectable internal consistency (Cronbach’s alpha = 0.75) and strong test-retest reliability (intraclass correlation coefficient or Pearson’s r = 0.75). Domain 1 (pruritus) and domain 5 (sleep disturbances) were the most affected, while domain 2 (swelling) was the least affected. UCT also showed excellent internal consistency (Cronbach’s alpha = 0.82) and acceptable test-retest reliability (Pearson’s r = 0.46). Construct validity was established through positive correlation coefficients with DLQI.

Conclusion:

The translated and validated CU-Q2oL and UCT questionnaires in Hindi provide valuable tools for assessing disease activity and quality of life in CU patients. These questionnaires can aid in research, enhance patient care, and improve disease management in the Hindi-speaking population. Their positive correlation with an established quality of life measure further validates their utility and reliability. Overall, this study should contribute to better healthcare outcomes for patients with CU in India.

Introduction

Chronic urticaria (CU) is a distressing skin condition characterised by transient pruritic wheals, with or without angioedema, persisting for more than 6 weeks.[1] CU affects between 0.5% and 1.5% of people worldwide, across all age categories, and it is more among the Asian population (1.4%) compared to Europe (0.5%) and Northern America (0.1%).[2] The quality of life is compromised among more than 30% of patients of CU, affecting patients’ sleep, physical and psychological health, social relationships, sexual function, work and family life, and sports activities. Thus, quality of life should be assessed routinely in all CU patients along with disease activity and control to evaluate disease burden and enhance therapeutic outcomes.[3] There is a lack of tools to assess the severity of disease control and its impact on the quality of life in the Indian Hindi-speaking population in their vernacular.

Treatment of CU should adhere to the fundamental principles of treating as little as necessary and as much as needed while considering that the disease’s activity may change. This involves using the principles of assess, adjust, act, and reassess to alter the therapy algorithm upwards or downwards based on the progression of the disease. It is crucial to emphasise that patients should receive appropriate counselling regarding ongoing care and the use of patient-reported outcome measures.

The international EAACI/GA²LEN/EuroGuiDerm/APAAACI 2022 guideline strongly (≥90% agreement) recommends the use of CU-Q2oL for assessing the quality of life impairment in patients with chronic spontaneous urticaria and the use of the UCT for assessing disease control in patients with CSU.[4]

The Dermatology Life Quality Index (DLQI) measures the quality of life for dermatological conditions through 10 questions.[5] Baiardini et al.[6] developed a specific questionnaire named Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) to assess the quality of life in CU patients. It consists of 23 questions divided into six domains [Table 1] using a 5-point Likert-type scale: ‘pruritus’ (2 items), ‘swelling’ (2 items), ‘impact on life activities’ (6 items), ‘sleep problems’ (5 items), ‘limits’ (3 items), and ‘looks’ (5 items).[7]

Table 1.

Number of questions according to domains for CU-Q2oL

Domains	Theme	Item number
Domain 1	Pruritus	1, 2
Domain 2	Swelling	3, 4
Domain 3	Impact on life activities	5, 6, 8–10
Domain 4	Sleep problems	7, 11, 14
Domain 5	Limits	17, 20, 22
Domain 6	Discomfort	15, 16, 18, 19, 23

To assess the degree of disease control in all types of CU (CSU and CIndU), the UCT was created and validated.[8] The Urticaria Control Test (UCT) is also a disease activity measuring tool along with the quality of life. It consists of four sets of questions measuring through a 5-point Likert scale graded from 0 to 4. Disease control is determined by UCT score where scores of <12, 12–15, and 16 indicate uncontrolled, well-controlled, and completely controlled CU, respectively [Figure 1].[4]

Figure 1.

Urticaria control according to UCT score (EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline, 2022)

This study aimed to adapt the CU-Q2oL and UCT to the Hindi language and evaluate its reliability, validity, and sensitivity to change. Thus, it is an utmost importance to develop a questionnaire in their own vernacular or translate and validate a questionnaire in Hindi from an already well-established questionnaire available in different languages.

Materials and Methods

Translation of the questionnaire

To generate the Hindi version, the standard procedure for translation was used.[9]

Forward translation

The initial translation from the English language to the Hindi language was made by two independent bilingual translators. Among them, one translator was aware of the concept. Discrepancies between the two translators were discussed and resolved by appointing a new unbiased, bilingual translator.

Backward translation

Backward translation to the English language was performed by two other independent translators. Both were unaware of the concept.

Expert committee

An expert committee was made to develop the pre-final version of the translation. The committee includes an expert who is familiar with the construct of interest, a methodologist, and both the forward and backward translators. The expert committee reviewed both versions of the translations and checked for semantic, idiomatic, experiential, and conceptual equivalence. Any discrepancies were resolved with discussion, and a pre-final version of the translated questionnaire was produced.

Preliminary pilot testing

The pre-final version of the translated questionnaire was pilot-tested on 10 people. The participants were asked to elaborate on what they thought each questionnaire item and their corresponding response meant. This allowed the investigator to compare the meaning of the original items with the translation and avoid any discrepancies.

Validating a questionnaire

After the new Hindi-translated questionnaire items passed through preliminary pilot testing and subsequent changes, they were checked for reliability and validity. Reliability indicates the consistency of the survey results and was evaluated using its internal consistency, test-retest reliability, and inter-rater reliability. The validity of a questionnaire indicates how perfectly it measures what it is intended to measure. Content validity and construct validity were the two major types of validity evaluated.

Internal consistency

It shows whether the questionnaire items are intercorrelated or they are measuring the same construct. It is commonly measured using the coefficient alpha (Cronbach’s alpha).[10] We considered the value of Cronbach’s α coefficient as follows: <0.60: unacceptable, 0.60–0.65: undesirable, 0.65–0.70: minimally acceptable, 0.70–0.80: respectable, 0.80–0.90: excellent, and >0.90: excessive consistency.[11] In our study, we selected the questions with Cronbach’s α of 0.70–0.90.

Test-retest reliability

It reflects how consistent an individual’s responses remain across repeated administration of the same questionnaire. It is measured by the intraclass correlation coefficient or Pearson’s r. It was measured across two visits 14 days apart (D0 and D14). The values of <0.4, 0.4–0.75, and >0.75 indicate poor, acceptable, and strong reliability, respectively.[12]

Inter-rater reliability

It evaluates the extent to which raters are consistent in their observations across the same group of examinees. It is estimated using the kappa statistic, where κ = 0 is considered as no agreement, κ = 0.01–0.20 as poor agreement, κ = 0.21–0.40 as slight agreement, κ = 0.41–0.60 as fair agreement, κ = 0.61–0.80 as good agreement, κ = 0.81–0.92 as very good agreement, and κ = 0.93–1 as excellent agreement.[13]

Validity

Content validity

The process of content validation is particularly important in the development of a new questionnaire. Thus, it has been avoided in this study.[9]

Construct validity

It is evaluated by estimating its association with another already established questionnaire with which it should be correlated positively, negatively, or not at all.[14] It estimates the expected patterns of associations between different measures of the new questionnaire with the already established tool. It is estimated as correlation coefficients (rs), where 0.1 is considered as small, 0.3 as moderate, and 0.5 as large.[15] We compared the CU-Q2oL and UCT with the English DQLI questionnaire.

The steps of developing a new questionnaire or translating from an already established questionnaire are demonstrated in Figure 2.

Figure 2.

The steps of developing a new questionnaire or translating from an already established questionnaire

Next, we performed a cross-sectional study at the Dermatology outpatient department (OPD) of a tertiary care hospital in India, across 1 month (May 2023). All adult (age >18 years) patients with CU were recruited after obtaining written informed consent, excluding patients with acute urticaria (<6 weeks), urticarial vasculitis, angioedema, psychiatric disorders, and any chronic disease with the potential to interfere with the quality of life. All patients were provided with the self-administrable CU-Q2oL, DLQI, and UCT questionnaires and asked to fill them by themselves or via an interview with a professional psychologist (illiterate, old-age patients) (day 0) and repeated on day 14 (re-test). We obtained the socio-demographic and disease parameters. Relevant laboratory investigations were performed. We recruited 42 patients; among them, 30 participated in the retest session after 14 days. Thus, the effective sample size was 30. Ethical committee is obtained from IEC Calcutta National Medical College and date of approval is 27/9/21.

Results

The mean age of our patients (n = 30) was 37.86 ± 11.69 (18–62) years. Most of the patients were female (male: female 11:19). The mean duration of CU was 16.06 ± 6.75 weeks. Table 2 highlights the demographic details of our patients.

Table 2.

Demographic profile of patients

Sex	Male	11 (36.7%)
	Female	19 (63.3%)
Marital status	Married	22 (73.3%)
	Unmarried	8 (26.7%)
Residence	Rural	17 (56.7%)
	Urban	13 (43.3%)
Literacy	Literate	14 (46.7%)
	Illiterate	16 (53.3%)
Employment	Employed	12 (40.0%)
	Unemployed/Homemaker	18 (60%)

Quality of life scores

In our patients, the mean CU-Q2oL score was 44.36 ± 14.68 [Table 3]. Domain 1 (pruritus) was most gravely affected (55.23 ± 12.59), followed by domain 4 (sleep disturbances) (50.45 ± 13.18). Domain 2 (swelling) (38.15 ± 16.69) and domain 6 (discomfort) were least affected (38.55 ± 15.69). Overall, females showed a higher score compared to males (49.77 ± 13.86 vs 48.43 ± 17.81, P = 0.8). Domain 1 (pruritus), domain 2 (swelling), domain 3 (impact of life activities), and domain 6 (discomfort) were more affected among females, whereas domain 4 (sleep disturbances) and domain 5 (limits) were more deranged among male [Table 3].

Table 3.

Domain-wise CU-Q2oL and UCT scores among patients

Parameters	Domain	Male	Female	Overall
CU-Q2oL	Domain 1	50.36±14.18	60.10±11.00	55.23±12.59
	Domain 2	32.16±17.15	44.13±16.10	38.15±16.69
	Domain 3	41.37±16.15	42.30±14.16	41.84±15.16
	Domain 4	51.17±13.20	49.72±13.16	50.45±13.18
	Domain 5	43.62±17.10	40.19±12.72	41.91±14.91
	Domain 6	36.79±14.10	40.36±17.57	38.55±15.69
	Overall	42.57±15.31	46.13±14.05	44.36±14.68
UCT	Overall	10.14±4.6	11.56±3.7	10.85±4.15

UCT was also poorer among females (mean 11.56 ± 3.7) than among males (mean 10.14 ± 4.6).

Internal consistency

The internal consistency of the questionnaire and test-re-test reliability are mentioned in Table 2. We found an overall respectable internal consistency (Cronbach’s alpha = 0.75) of the CU-Q2oL. The internal consistency of UCT was excellent (Cronbach’s alpha = 0.82).

Inter-rater reliability

We found a very good agreement (κ =0.81) in CU-Q2oL and a good agreement (κ =0.73) in UCT among two different raters.

Test-retest reliability

We recorded the CU-Q2oL and UCT of the same individual on day 1 and day 14. We found strong reliability (Pearson’s r = 0.76, P = 0.021) in CU-Q2oL and acceptable reliability (Pearson’s r = 0.46, P = 0.004) among the participants in UCT. Table 4 demonstrates domain-wise internal consistency and test-retest reliability of the Hindi CU-QOL and UCT.

Table 4.

Domain-wise internal consistency and Test-retest reliability of the Hindi CU-Q2oL and UCT

PROM	Domain	Cronbach’s alpha	Test-retest ICC (Pearson’s r)
CU-Q2oL	Domain 1	0.76	0.75
	Domain 2	0.65	0.70
	Domain 3	0.80	0.86
	Domain 4	0.70	0.75
	Domain 5	0.75	0.60
	Domain 6	0.85	0.84
	Overall	0.75	0.76 (P=0.021)
UCT	Overall	0.82	0.46 (P=0.004)

Correlation coefficients of construct validity

We found large positive correlation coefficients (rs = 0.51) with Hindi CU-Q2oL and small positive correlation coefficients (rs = 0.27) with UCT when we compared it with the English DLQI score.

Discussion

CU-Q2oL and UCT questionnaires are widely acceptable for assessing urticaria activity, the effectiveness of drugs, and in the field of research. The availability of this questionnaire in native languages is of utmost necessity to understand the disease progression better. We need to adapt, translate, and validate this questionnaire in the Hindi language, as it is the most broadly spoken language in India, to widen its use and convenience. This questionnaire is self-administered and easy to understand. The original version was developed by Baiardini in 2005 and had six domains.[6] Subsequently, it has been translated into many languages such as German,[16] Spanish,[17] Polish,[18] Persian,[19] Turkish,[20] Arabic,[12] and Bengali.[21]

In our patients, domain 1 (pruritus) was most severely affected, followed by domain 5 (sleep disturbances), which is similar to most of the other populations.[16,17,18,19,20] Dhabal et al. showed the most affected domain was ‘sleep problems’ followed by ‘pruritus’ in their study.[21] Swelling (domain 2) was least affected in our patients, consistent with the Arabic and Bengali version.[12,21]

Regarding internal consistency, our Hindi version of the CU-Q2oL portrayed a respectable overall Cronbach’s alpha value of 0.75, much higher than the recommended threshold of 0.70. All our individual domains also documented a score of >0.70, except domain 2 (swelling). It reflects that the questionnaire items are well intercorrelated. In terms of test-retest reliability, our version showed strong reliability with an overall intraclass correlation coefficient or Pearson’s r value of 0.75 and all individual domains having intra-class correlation coefficient values above 0.75, except domain 2 and domain 5. It reflects the consistency of an individual’s responses across repeated administration. Our findings are comparable to or better than the corresponding results for the original questionnaire as well as its other translations.[12,16,17,18,19,20] Our Hindi version of UCT also demonstrated excellent internal consistency (Cronbach’s alpha = 0.82) and acceptable test-retest reliability (Pearson’s r = 0.46). Concerning the inter-rater agreement between two experts, we found a very good agreement in CU-Q2oL and a good agreement in UCT. We also established a positive correlation coefficient with DLQI, which measures the construct validity of both questionnaires. Israeli and Arabic versions showed stronger positive correlation coefficients with DLQI, and the Bengali version showed a positive correlation coefficient with Bengali CU-Q2oL and a negative correlation coefficient with Bengali UCT [Supplements 1 and 2].[12,21,22]

Limitation

Our study was limited by its small sample size, observational design, and recall bias. In addition, we failed to establish domain-wise inter-rater reliability and correlation coefficient.

Conclusion

Our Hindi translation of the CU-Q2oL had strong psychometric qualities that were comparable to translations in other languages. Comparing the comparable scores with patients whose CU-Q2oL has been validated in their mother language may be deemed appropriate for use among Hindi-speaking patients with CU in both research and therapeutic settings. The validated Hindi version of the UCT questionnaire has minimally noteworthy differences, is easy to use, and is suitable for treatment and research purposes.

Conflicts of interest

There are no conflicts of interest.

Supplement 1.

Supplement 2.

Funding Statement

Nil.