Translation and validation of the Quality of Life in Hand Eczema Questionnaire (QOLHEQ) in the Greek language

To the Editor, Previously a quality of life measurement instrument specific for hand eczema (HE) was developed, the Quality of Life in Hand Eczema Questionnaire (QOLHEQ). To date, in addition to the German version, Japanese, Dutch and Danish language versions have been validated. A Greek version of the QOLHEQ is lacking. The aim of this study was to assess the validity and reproducibility of the Greek QOLHEQ. This study was conducted in line with a formerly reported guideline that complies with the guidance developed by the Consensusbased Standards for the Selection of Health Measurement Instruments (COSMIN) group in order to test content and structural validity, internal consistency, reliability and interpretability. The QOLHEQ is a 30-item questionnaire. Each item has five possible response options (never, rarely, sometimes, often, all the time) evaluating impairment of health-related quality of life (HRQOL) in four domains, that is, (a) symptoms, (b) emotions, (c) functioning and (d) treatment & prevention. The original version of the QOLHEQ (Supplemental document S1) was translated by two translators (Tr1 and Tr2) with Greek, language as their mother language. One translator (Tr1) was a Greek dermatologist with expertise in HE who was aware of the definition of HRQOL and the multidimensional construct of the QOLHEQ. The second translator (Tr2) did not have experience in HE and was not given the definition of the construct. The two translators integrated the two translated versions into one (version Tr-12). Then, a back-translation (BT1) of the Tr-12 version was performed. The BT1 version was reviewed by the developers of the QOLHEQ and resulted in a prefinal language version of the QOLHEQ. The pre-final version was tested in a cognitive interview pilot study with 15 HE patients with varying disease severity, to assess content validity, comprehensibility, relevance, completeness and cultural difficulties/differences. The final Greek version is provided as Supplemental document S2. An item/subject proportion of 1:10 was used which led to an estimated sample size of 300 participants. Inclusion criteria were (i) adult patients aged more than 18 years old with (ii) a past medical history of HE of at least seven days duration as diagnosed by a dermatologist. Exclusion criteria were (i) other skin-related conditions of the hands and (ii) the patient's incapacity to fill in the questionnaire by themselves. Recruitment was performed between January 2019 and July 2020 at the University Hospital of Heraklion in Greece. Ethical approval was obtained from the Ethical Medical Review Board of the hospital (reference 14943/16-10-2018). Consecutive patients with HE were requested to complete the QOLHEQ and multiple reference instruments at three points (T0, baseline; T1, after 1–3 days; T2, after 4–12 weeks), and their HE was also clinically assessed. In this letter, we report on the data assessed at T0 and T1. The following reference instruments were used: A photographic guide HE severity instrument, in which the HE severity is evaluated by the healthcare professional on a five-point rating scale (clear, almost clear, moderate, severe and very severe) was used as Physician's Global Assessment, PGA, of HE severity. Furthermore, we evaluated the HE disease severity as rated by the patient using a 10-point numeric rating scale (NRS). The Skindex-16 was used as instrument designed to measure the effects of skin diseases on patients' HRQOL. It is composed of 16 items, scored on a 7-point scale, grouped under three subscales: symptoms, emotions and functioning. Subscale scores are converted to a continuous scale of 0– 100, where higher scores indicate more impaired levels of HRQOL. We evaluated general HRQOL, by utilizing the EQ-5D-5L and EQ visual analogue scale (EQ-VAS). Each domain of health is assessed with an item scored on a five-point grade (no problems, slight problems, moderate problems, severe problems or extreme problems), and the responses are converted into a utility score fluctuating from 0 (death) to 1 (full health). Those health states are allocated utility values (i.e., EQ-5D-5L index score) attained from population studies reflecting the societal values. Cronbach's alpha was calculated as a measure of internal consistency for each domain. Test–retest reliability was assessed by calculating Intra-Class-Correlation (ICC) coefficients between baseline data and retest after 2–3 days. For both of these calculations, values ranging from 0.70 to 0.95 were considered to represent a good consistency. In total, we recruited 300 HE patients for the study. Patients were aged from 18 to 89 years (mean 45.6; SD 14.2) and 65.3% were female. In all analysis, the amount of missing values was <2%. According to PGA 37.3% of patients had a moderate and 21.3% had a severe HE, severity was nearly normally distributed in the sample. Cronbach's alpha was found to be 0.85–0.93 for the QOLHEQ subdomains (symptoms: 0.87; emotions: 0.93; functioning: 0.91 and treatment/ prevention: 0.85) and also the ICC coefficients were in a range from 0.89 to 0.94 indicating a good test–retest reliability. Concerning Abbreviations: BT1, back translation 1; EQ VAS, EuroQol visual analogue scale; EQ5D 5L, EuroQol-5 Dimension; HE, hand eczema; HRQOL, health-related quality of life; ICC, intraclass-correlation; NRS, numeric rating scale; QOLHEQ, Quality of Life in Hand Eczema Questionnaire; T0, baseline patient's visit; T1, after 1–3 days patient's visit; T2, after 4– 12 weeks patient's visit; Tr1, translator 1; Tr2, translator 2. Received: 31 July 2022 Revised: 13 September 2022 Accepted: 21 September 2022