Life In Hand Eczema Questionnaire Research Articles

Efficacy of apremilast in hyperkeratotic hand and foot dermatitis: results from a randomized observer-blinded comparative study.

Hyperkeratotic hand and foot dermatitis significantly affects quality of life. Some patients respond suboptimally to topical corticosteroids and have multiple recurrences. Our aim was to compare the efficacy and safety profile of apremilast and topical corticosteroid versus corticosteroid alone in hyperkeratotic hand and foot dermatitis. This randomized controlled study involved 77 patients treated for 3 months. GroupA (39 patients) received mometasone furoate 0.1% cream with oral apremilast 30 mg twice daily, and Group B (38 patients) received mometasone alone. They were assessed monthly using the Hand Eczema Clinical Severity Index (HECSI) and Visual Analogue Scale (VAS) scores for pruritus. Investigator Global Assessment (IGA) and Quality of Life in Hand Eczema Questionnaire (QOLHEQ) were conducted at the end of 3 months. The HECSI, VAS score, and QOLHEQ showed a significant decrease in both groups from baseline to the third month. Intergroup comparisons of HECSI failed to reach the significance level. When compared, patients receiving apremilast had significantly better improvement in the third month according to the Patient Global Assessment (PGA) and Investigator Global Assessment (IGA). They also had a smaller number of flares. Adding apremilast to topical corticosteroid leads to better patient and physician-perceived improvement and reduces the number of flares in hyperkeratotic hand eczema.

Cream versus ointment: Randomized single-blinded study on the adherence to treatment with topical methylprednisolone aceponate.

Overall adherence in the treatment of chronic dermatoses is poor. Textbooks state an adherence dependence on galenics. Prospective, randomized, parallel-grouped, single-blinded (investigator), monocentric clinical trial (phase IV) on the adherence to treatment of chronic mild to moderate hand eczema with topical methylprednisolone aceponate (MPA, Advantan®) in different vehicles. Primary objective was the assessment of the adherence depending on vehicle type in patients with chronic hand eczema. Secondary objective was improvement after a 4-week treatment period. Primary Endpoint Adherence is defined as the percentage of patients applying at least aimed daily dose. Prescribed daily dose was defined as the planned number of applications per day (1) * surface (measured) * aimed amount per application (mg/cm2 ). Truly applicated daily dose was evaluated as individual mean amount per dose * individual mean number of applications per day. Adherence was assumed, if truly applicated daily dose is at least 75% of the prescribed daily dose and the individual mean number of applications per day is at least 0.85. Secondary Endpoint Efficacy was measured by improvement of Hand Eczema Severity Index (HECSI) and Investigator's Global Assessment (IGA) after a 4-week treatment period and in addition to Quality of Life in Hand Eczema Questionnaire (QOLHEQ) and Visual Analogue Scale (VAS) to assess pruritus. Number of participants randomized to each group 40, 80 total. Group 1 MPA-C: Methylprednisolone aceponate 0.1% cream and barrier repair emollient (Bepanthen® Sensiderm). Group 2 MPA-FO: Methylprednisolone aceponate 0.1% fatty ointment and barrier repair emollient (Bepanthen® Sensiderm). Adherence to treatment was compared via Fisher's exact test. Of the patients, 48% were adherent according to our definition. There was no significant difference between MPA-C (42.1%) and MPA-FO (54.1%; p = 0.36; group difference-12.0%, 95% CI-34.3%-11.5%). Generalized-linear-model-analysis of adherence to study treatment with factors emollient use, treatment, time and treatment-time interaction showed a parallel between adherence and amount of emollient use (odds ratio 1.74, p = 0.0038; 95% CI-1.22-2.52). Improvement of hand eczema was seen according to clinical scores without remarkable differences between the groups. No dependence of adherence on galenics of topical treatment of chronic hand eczema could be proved. Patients who use more emollient tend to be more adherent to the topical treatment.

Chronic hand eczema: A prevalent disease in the general population associated with reduced quality of life and poor overall health measures.

The impact of hand eczema (HE) on Health-Related Quality of Life (HRQoL) has only been sparsely studied in a general population setting, and never by use of the disease specific Quality Of Life in Hand eczema Questionnaire (QOLHEQ). To examine the HRQoL of unselected individuals with HE using the QOLHEQ. Further, to provide prevalence estimates of severe and chronic HE (CHE), and to contrast overall health related outcomes between individuals with and without HE. In this nationwide, cross-sectional study a questionnaire covering questions on HE related outcomes, and overall health was sent to a random sample of 100 000 Danish adults via a secure digital mailbox, linked to their unique civil registration numbers. Data on demographic characteristics were retrieved from the civil registration system. Individuals reporting HE, further answered the QOLHEQ and other disease specific questions. The response rate was 42.7% (n = 42 691). Total estimates of lifetime, 1-year and point prevalences of HE were 24.4%, 13.3% and 5.8%. Of individuals reporting a 1-year prevalence, 35.1% reported moderate-severe disease and 82.6% CHE. Individuals with HE were more likely to report less good or poor overall health, and sick leave (any reason), compared to those without. In the 2176 (92.5%) with current HE who completed the QOLHEQ, median QOLHEQ scores corresponded to a moderate impairment of the symptoms and treatment and prevention domains and a slight impairment overall and for the emotions and functioning domains. Factors that were strongly associated with moderate to severe HRQoL impairment included severe, chronic and occupational HE as well as female sex. HE is highly prevalent, bears a considerable burden on society and significantly affects the lives of impacted individuals. Our findings indicate a necessity for targeted prevention aimed at high-risk groups, and support and treatment for those most affected.

Efficacy and Safety of Fractional CO2 Laser Combined with Halometasone Cream for Treatment of Moderate-to-Severe Chronic Hand Eczema: A Prospective, Single-Center, Parallel-Group, Open-Label Randomized Trial.

The purpose of this study was to assess the efficacy and safety of fractional CO2 laser combined with halometasone cream in patients with moderate-to-severe chronic hand eczema (CHE). A prospective, single-center, parallel-group, open-label randomized trial including 67 patients with moderate-to-severe CHE was carried out. Patients were randomly assigned to group A (n = 33, fractional CO2 laser once every 4weeks 1-2 times and halometasone cream twice daily for 8weeks) or group B (n = 34, halometasone cream alone twice daily for 8weeks). The primary endpoint was the proportion of patients achieving treatment success at week12 in each group. Secondary endpoints included differences between groups in the change of hand eczema severity index (HECSI), patient global assessment (PaGA), dermatology life quality index (DLQI), and quality of life in hand eczema questionnaire (QOLHEQ) from baseline to week12. Relapse rate and adverse effects were also recorded. A total of 29 patients in each group completed the trial. At week12, the treatment success rate was 62.1% (18/29) in group A and 27.6% (8/29) in group B (p = 0.009). At week12, HECSI, PaGA, DLQI, and QOLHEQ all decreased compared with baseline in both groups (p < 0.05). HECSI, DLQI, and QOLHEQ decreased more in group A than group B (p = 0.014, 0.010, and 0.014, respectively), but there was no significant difference in change of PaGA between the two groups (1.0 versus 3.0, p = 0.419). Among patients achieving treatment success, 11.1% (2/18) patients in group A and 50.0% (4/8) patients in group B relapsed at week24 (p = 0.011). Skin pigmentation was the most common adverse effect. For patients with moderate-to-severe CHE, fractional CO2 laser combined with halometasone cream is more effective than halometasone cream alone, with few adverse effects. ChiCTR2100051948.

Validation of the Danish version of the Quality of Life in Hand Eczema Questionnaire ( QOLHEQ )

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The long-term effect of dupilumab on chronic hand eczema in patients with moderate to severe atopic dermatitis-52 week results from the Dutch BioDay Registry.

BackgroundThe hands are a common predilection site of atopic dermatitis (AD). Dupilumab is licensed for the treatment of AD but not for chronic hand eczema (CHE), while CHE is challenging to treat.ObjectivesTo evaluate the long‐term effect of dupilumab on hand eczema (HE) in patients with AD from the BioDay Registry.MethodsA prospective observational study of adult patients with HE, treated for AD with dupilumab. Patients with a HE severity of at least moderate at baseline were considered for analysis. Patients with other concomitantly systemic immunosuppressive treatments were excluded. Clinical effectiveness on HE severity, using the Hand Eczema Severity Index (HECSI) and photographic guide, and health‐related quality of life, using the Quality of Life in Hand Eczema Questionnaire (QOLHEQ), were evaluated.ResultsA total of 72 patients were included. HECSI‐75 was achieved by 54/62 patients (87.1%) and HECSI‐90 by 39/72 (62.9%) at 52 weeks. Based on the photographic guide, 56/62 patients (90.3%) achieved the endpoint of ‘clear’ or ‘almost clear’. Mean QOLHEQ reduction was −63.5% (95% confidence interval −38.23 to −27.41). There was no difference in response between HE subtypes.ConclusionsThe results from this study hold promise for dupilumab to be a suitable treatment option for isolated CHE.

Baricitinib treatment of severe chronic hand eczema: Two case reports

Baricitinib treatment of severe chronic hand eczema: Two case reports

Testing a quality‐of‐life questionnaire in Dutch people with hand eczema

British Journal of DermatologyVolume 183, Issue 1 p. e11-e11 Plain Language SummaryFree Access Testing a quality-of-life questionnaire in Dutch people with hand eczema First published: 01 July 2020 https://doi.org/10.1111/bjd.19181AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Abstract Hand eczema interferes with many aspects of everyday life. This is an important consideration but such interference is hard to measure. Any scoring system must itself be carefully assessed to make sure it is relevant, reliable and sensitive enough to pick up any meaningful change before and after any new treatment. Doctors in the Netherlands studied the Dutch version of an internationally recognised measurement instrument (system), the Quality Of Life in Hand Eczema Questionnaire (QOLHEQ). This instrument has 30 questions covering symptoms, emotions, functioning and treatment during the past week, with answers on a five-point scale. They tested it on 300 adults and repeated the test after 3 days and 4-12 weeks. They also photographed and scored the hand eczema severity and used several other quality of life measures for comparison. QOLHEQ scores from people whose eczema was unchanged after 3 days, according to a global severity score, were used to assess how reproducible this measurement was; and those whose global severity score changed after 3 days to 4-12 weeks were used to see how sensitive the test was to change. The authors used rigorous statistical tests to check that their findings were sound. They had to adjust the score in some respects and the final version of the Dutch QOLHEQ gave a maximum of 89 points made up of 21 for symptoms, 24 each for emotions and functioning and 20 for treatment. They conclude that the final version is valid, reproducible and responsive. The authors estimate that an improvement of at least 15 points represents a genuine improvement for Dutch patients. Linked Article: Oosterhaven et al. Br J Dermatol 2020; 183:86–95. Volume183, Issue1July 2020Pages e11-e11 RelatedInformation

New evidence for construct validity and interpretability of the German Quality of Life in Hand Eczema Questionnaire (QOLHEQ).

The Quality of Life in Hand Eczema Questionnaire (QOLHEQ) is a disease-specific instrument used to assess health-related quality of life (HRQoL) in patients with hand eczema according to the domains of (a) symptoms, (b) emotions, (c) functioning, and (d) treatment/prevention. Today it is not clear what a single score of the QOLHEQ in its German-language version means to a patient. It was the aim of this study to band the QOLHEQ score to an anchor question (AQ) in order to obtain meaningful categories of the QOLHEQ to aid its interpretation. In addition, we assessed the minimal important change (MIC) by using anchor- and distribution-based methods. Overall n = 440 hand eczema patients were included in the study. Mean age was 47.5 years (SD 11.9); 38.4% of the sample were female. With a weighted kappa of 0.62, the total QOLHEQ score showed the best agreement for the following band: QOLHEQ of <17 = no impairment; QOLHEQ of 18-28 = slight impairment; QOLHEQ of 29-41 = moderate impairment; QOLHEQ of 42-79 = severe impairment; and QOLHEQ of >79 = very severe impairment. The MIC for the total score was found to be 16.5 points. This banding represents a standardized means of interpreting the QOLHEQ total score. Our results indicate that a banding study should be performed for each language version of the QOLHEQ.

Quality of life, treatment satisfaction, and adherence to treatment in patients with vesicular hand eczema: A cross-sectional study.

Recurrent vesicular hand eczema frequently has a chronic course and needs long-term treatment. To evaluate health-related quality of life (HRQoL), treatment satisfaction, and adherence in patients with vesicular hand eczema. Patients using one main treatment for at least three months were included. Data on HRQoL (Quality of Life in Hand Eczema Questionnaire [QOLHEQ]), treatment satisfaction (Treatment Satisfaction Questionnaire for Medication, version II), and treatment adherence (4-item Morisky Medication Adherence Scale) were collected. Univariate and multivariate regression analysis were used to predict variables associated with HRQoL. HRQoL was moderately impaired, with the highest impact in the QOLHEQ subdomain symptoms. Female sex, more severe hand eczema, and lower treatment satisfaction were associated with more impairment in HRQoL. Patients with severe/very severe hand eczema had significant lower "global satisfaction" scores compared with the other severity groups. The "global satisfaction" and treatment adherence in patients using systemic treatment were significantly higher compared with those with only topical treatment. In patients with vesicular hand eczema disease severity affects both HRQoL and treatment satisfaction. Systemic treatment of severe hand eczema could improve the severity and as a result also HRQoL, treatment satisfaction, and medication adherence.

Validation of the Dutch Quality of Life in Hand Eczema Questionnaire (QOLHEQ).

SummaryBackgroundMeasurement instruments should be validated for use in the population for which they are intended. The Quality of Life in Hand Eczema Questionnaire (QOLHEQ) has been developed to measure impairment of health‐related quality of life in patients with hand eczema.ObjectivesTo assess validity, reproducibility, responsiveness and interpretability of the Dutch version of the QOLHEQ.MethodsThis was a prospective validation study in adult patients with hand eczema. At three time points (T0, baseline; T1, after 1–3 days; T2, after 4–12 weeks), data from the QOLHEQ and multiple reference instruments were collected. Scale structure was assessed using item response theory analysis and structural equation modelling (SEM). Single‐score validity and responsiveness were tested with hypotheses on correlations with reference instruments. Concerning reproducibility, intraclass correlation coefficients (ICC agreement) and standard error of agreement (SEM agreement) were checked. Regarding interpretability, bands for severity of quality‐of‐life impairment were proposed. Also, smallest detectable change (SDC) and minimally important change (MIC) were determined.ResultsAt T0, 300 individuals participated in the study (54% were male, mean age 45 years). Rescoring of the scale structure fitted the Rasch model and the SEM. The ICC agreement was 0·91 (95% confidence interval 0·85–0·94) and the SEM agreement was 5·2 points. Of the a priori formulated hypotheses, 80% (single‐score validity) and 64% (change scores for responsiveness) were confirmed. The SDC was 14·4 points and the MIC was 11·5 points.ConclusionsThe Dutch version of the QOLHEQ has a good structural validity and reproducibility and has a high single‐score validity and moderate responsiveness. An improvement of ≥ 15 points should be regarded as a real, important change within the Dutch population. What's already known about this topic? The Quality of Life in Hand Eczema Questionnaire (QOLHEQ) measures impairment of health‐related quality of life (HRQoL) in patients with hand eczema.The QOLHEQ was validated in Germany and Japan, but the validity and interpretability of the Dutch version are unknown. What does this study add? This study shows that the Dutch QOLHEQ is a valid instrument to measure HRQoL impairment in Dutch patients with hand eczema, demonstrating good reliability and moderate responsiveness.Methods of item response theory are applied to assess and refine the scoring structure.Severity gradings to interpret single and change scores, specifically in Dutch patients, are proposed. What are the clinical implications of this work? The Dutch QOLHEQ can now be used to measure HRQoL impairment in Dutch patients with hand eczema.

PSY52 PATIENT-REPORTED OUTCOME MEASURES IN ATOPIC DERMATITIS AND CHRONIC HAND ECZEMA IN ADULTS

Patient-reported outcome measures (PROMs) provide an important complement to physician-assessed clinical outcome measures in dermatologic diseases such as atopic dermatitis (AD) and chronic hand eczema (CHE). AD and CHE are chronic and relapsing inflammatory skin conditions that often co-occur. While both diseases result in various signs and symptoms that are burdensome and can negatively affect patients’ lives, there may be distinct differences in the signs, symptoms, burden, and health-related quality of life (HRQOL) impact of these diseases. The objective of this study was to identify and evaluate PROMs used in studies of AD and CHE. The aim was to explore the assessment of key symptoms and impacts, and identify any gaps in the measures in use. A structured review of the PubMed database was conducted to identify PROMs used or developed for use in AD or CHE. The Dermatology Life Quality Index (DLQI), the Pruritus/Itch Numeric Rating Scale (NRS), the Patient-Oriented Eczema Measure (POEM), and the Quality of Life in Hand Eczema Questionnaire (QOLHEQ) were identified and reviewed in detail. With these measures, the AD and CHE symptoms and impacts most commonly evaluated in the literature include dermatology-related HRQOL in the domains of symptoms and feelings, daily activities, leisure, work and school, personal relationships, and adverse effects; pruritus; sleep disturbance; AD-specific symptoms (dryness, itching, flaking, cracking, bleeding, and weeping/oozing); and CHE-specific symptoms (pain, itch, fissuring, redness, bleeding, and dryness). A review of regulatory labels of drugs approved for AD by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) found that, among the four measures reviewed, the Pruritus NRS was included in the FDA and EMA labels for dupilumab, the DLQI was included in the EMA labels for dupilumab and tacrolimus, and the POEM was included in the EMA label for dupilumab. Key symptoms of AD (e.g. itching, flaking, cracking) and CHE (e.g. pain, itching, fissuring) are increasingly being assessed with PROMs; however, primary endpoints in clinical trials are often based on clinician-reported outcome measures. As therapeutic strategies in dermatology are targeted at specific dermatologic symptoms and diseases affecting specific sites (e.g. CHE), future research should explore patients’ experiences with these symptoms and sites and the changes with treatment that are most meaningful to them.

Interpretability of the Quality Of Life in Hand Eczema Questionnaire

The Quality Of Life in Hand Eczema Questionnaire (QOLHEQ) is used to measure impairment of health-related quality of life in hand eczema. Here, we prospectively studied the interpretability of international QOLHEQ scores at three time points: baseline, after 1-3 days (T1), and after 4-12 weeks (T2). Adult patients with hand eczema completed the QOLHEQ and anchor questions for overall assessment of health-related quality of life impairment. Interpretability of single scores was assessed at baseline by defining severity bands based on agreement with the anchor questions. Smallest detectable change was calculated at T1. Minimally important change of improvement was calculated at T2 using three methods: mean cut-off, receiver operating characteristic, and 95% limit. A total of 294 adult patients were included (160 males, mean age 44.9 years). The final proposed severity band of overall QOLHEQ single scores (κ-coefficient of agreement, 0.431) was not at all, 0-10; slightly, 11-39; moderately, 40-61; strongly, 62-86; and very strongly, ≥87. Separate overall severity bands were proposed for males and females and the four subscales of the QOLHEQ. The smallest detectable change in 166 unchanged patients was 18.6 points. The preferred minimally important change, obtained with the receiver operating characteristic method, was 21.5 points. An overall QOLHEQ score of ≥22 is recommended as cut-off for a minimally important, real change.

Patient-Reported Outcome Measures in Atopic Dermatitis and Chronic Hand Eczema in Adults.

Patient-reported outcome measures (PROMs) provide an important complement to physician-assessed clinical outcome measures in dermatologic diseases such as atopic dermatitis (AD) and chronic hand eczema (CHE). AD and CHE are chronic and relapsing inflammatory skin conditions that often co-occur. While both diseases result in various signs and symptoms that are burdensome and can negatively affect patients’ lives, there may be distinct differences in the signs, symptoms, burden, and health-related quality of life (HRQOL) impact of these diseases. The objective of this study was to identify and evaluate PROMs used in studies of AD and CHE. The aim was to explore the assessment of key symptoms and impacts, and identify any gaps in the measures in use. A structured review of the PubMed database was conducted to identify PROMs used or developed for use in AD or CHE. The Dermatology Life Quality Index (DLQI), the Pruritus/Itch Numeric Rating Scale (NRS), the Patient-Oriented Eczema Measure (POEM), and the Quality of Life in Hand Eczema Questionnaire (QOLHEQ) were identified and reviewed in detail. With these measures, the AD and CHE symptoms and impacts most commonly evaluated in the literature include dermatology-related HRQOL in the domains of symptoms and feelings, daily activities, leisure, work and school, personal relationships, and adverse effects; pruritus; sleep disturbance; AD-specific symptoms (dryness, itching, flaking, cracking, bleeding, and weeping/oozing); and CHE-specific symptoms (pain, itch, fissuring, redness, bleeding, and dryness). A review of regulatory labels of drugs approved for AD by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) found that, among the four measures reviewed, the Pruritus NRS was included in the FDA and EMA labels for dupilumab, the DLQI was included in the EMA labels for dupilumab and tacrolimus, and the POEM was included in the EMA label for dupilumab. Key symptoms of AD (e.g. itching, flaking, cracking) and CHE (e.g. pain, itching, fissuring) are increasingly being assessed with PROMs; however, primary endpoints in clinical trials are often based on clinician-reported outcome measures. As therapeutic strategies in dermatology are targeted at specific dermatologic symptoms and diseases affecting specific sites (e.g. CHE), future research should explore patients’ experiences with these symptoms and sites and the changes with treatment that are most meaningful to them.Electronic supplementary materialThe online version of this article (10.1007/s40271-019-00373-y) contains supplementary material, which is available to authorized users.

Quality of Life in Hand Eczema Questionnaire: Validation of the Japanese version of a disease-specific measure of quality of life for hand eczema patients.

Hand eczema (HE) is a common skin disease that impairs health-related quality of life (HRQOL). Impairments in HRQOL have already been reported in Japanese HE patients using the Skindex-16. Recently, an instrument to measure disease-specific HRQOL in HE patients was developed by an international expert group, consisting of domains for: (i) symptoms; (ii) emotions; (iii) functioning; and (iv) treatment and prevention. The objective of this study is to translate the English-language version of the Quality of Life Hand Eczema Questionnaire (QOLHEQ) to Japanese and then to validate the Japanese version. The Japanese version of the QOLHEQ, the Dermatological Life Quality Index (DLQI) and a questionnaire regarding basic demographic information, including patient ratings of HE severity, were distributed to Japanese HE patients. Additionally, a dermatologist evaluated patients' HE severity using the Physician Global Assessment. A total of 124 patients with a mean age of 43.7 years were included in the analysis, and 78% of the sample was female. Cronbach's alphas for the domains symptoms, emotions, functioning, and treatment and prevention were 0.76, 0.89, 0.88 and 0.81, respectively. The total QOLHEQ score showed a strong correlation with the DLQI, a moderate correlation with patient-rated severity and weak correlations with dermatologist-rated severity and the number of consultations. The Japanese version of the QOLHEQ showed excellent reliability and high validity. The Japanese version of the QOLHEQ is ready for use in epidemiological studies to evaluate HRQOL impairments in HE patients.

Study protocol: efficacy of oral alitretinoin versus oral cyclosporine A in patients with severe recurrent vesicular hand eczema (ALICsA): a randomised prospective open-label trial with blinded outcome assessment

IntroductionSystemic treatment with alitretinoin is registered for all clinical types of severe chronic hand eczema. However, it is especially effective in the hyperkeratotic subtype and less effective in non-hyperkeratotic forms....

Guideline for translation and national validation of the Quality of Life in Hand Eczema Questionnaire (QOLHEQ)

There is a need for well-developed and validated questionnaires to measure patient reported outcomes. The Quality of Life in Hand Eczema Questionnaire (QOLHEQ) is such a validated instrument measuring disease-specific health-related quality of life in hand eczema patients. A re-validation of measurement properties is required before an instrument is used in a new population. With the objective of arriving at a guideline for translation and national validation of the QOLHEQ, we have developed the design of a reference study on how to adequately assess measurement properties of the QOLHEQ based on interdisciplinary discussions and current standards. We present a step-by-step guideline to assess translation (including cross-cultural adaptation), scale structure, validity, reproducibility, responsiveness, and interpretability. We describe which outcomes should be reported for each measurement property, and give advice on how to calculate these. It is also specified which sample size is needed, how to deal with missing data, and which cutoff values should be applied for the measurement properties assessed during the validation process. In conclusion, this guideline, presenting a reference validation study for the QOLHEQ, creates the possibility to harmonize the national validation of the various language versions of the QOLHEQ.

Cross-Cultural Validation of the Quality of Life in Hand Eczema Questionnaire (QOLHEQ)

The Quality of Life in Hand Eczema Questionnaire (QOLHEQ) is the only instrument assessing disease-specific health-related quality of life in patients with hand eczema. It is available in eight language versions. In this study we assessed if the items of different language versions of the QOLHEQ yield comparable values across countries. An international multicenter study was conducted with participating centers in Finland, Germany, Japan, The Netherlands, Sweden, and Turkey. Methods of item response theory were applied to each subscale to assess differential item functioning for items among countries. Overall, 662 hand eczema patients were recruited into the study. Single items were removed or split according to the item response theory model by country to resolve differential item functioning. After this adjustment, none of the four subscales of the QOLHEQ showed significant misfit to the item response theory model (P < 0.01), and a Person Separation Index of greater than 0.7 showed good internal consistency for each subscale. By adapting the scoring of the QOLHEQ using the methods of item response theory, it was possible to obtain QOLHEQ values that are comparable across countries. Cross-cultural variations in the interpretation of single items were resolved. The QOLHEQ is now ready to be used in international studies assessing the health-related quality of life impact of hand eczema.

The Quality of Life in Hand Eczema Questionnaire (QOLHEQ): validation of the German version of a new disease-specific measure of quality of life for patients with hand eczema

Health-related quality of life (HRQOL) is widely used as a patient-reported outcome to evaluate clinical trials. In routine care it can also be used to improve treatment strategies or to enhance patients' self-awareness and empowerment. Therefore a disease-specific instrument is needed that assesses in detail all the impairments caused by the disease of interest. For patients with hand eczema (HE) such an instrument was developed by an international expert group, but its measurement properties are unknown. To validate the German version of the Quality of Life in Hand Eczema Questionnaire (QOLHEQ), which covers the domains of (i) symptoms, (ii) emotions, (iii) functioning and (iv) treatment and prevention. The QOLHEQ was assessed up to three times in 316 patients with HE to test reliability and sensitivity to change. To test construct validity we also assessed several reference measures. The scale structure was analysed using the Rasch model for each subscale and a structural equation model was used to test the multi domain structure of the QOLHEQ. After minor adaptions of the scoring structure, all four subscales of the QOLHEQ did not significantly misfit the Rasch model (α>0·05). The fit indices of the structural equation model showed a good fit of the multi domain construct with four subscales assessing HRQOL. Nearly all a priori-defined hypotheses relating to construct validity could be confirmed. The QOLHEQ showed a sensitivity to change that was superior compared with all reference measures. The QOLHEQ is ready to be used in its German version as a sensitive outcome measure in clinical trials and for routine monitoring. The treatment-relevant subscales enable its use to enhance patients' self-awareness and to monitor treatment decisions.

The Quality of Life in hand eczema questionnaire: validation of a new assessment instrument

Background: Health related Quality of Life (HRQOL) is a patient reported outcome (PRO) used to evaluate clinical trials in various diseases. Health economic decisions are often based on HRQOL data, especially where the disease of interest is a chronic non life-threatening condition. Since there is no disease-specific HRQOL instrument to assess the impairments of patients with hand eczema (HE) we set out to develop an instrument to assess HE-specific HRQOL. The development process was done in an international group in order to receive an instrument which works in a culturally equivalent manner in different countries. Here we present the validation study of the German language version of the Quality of Life in hand eczema Questionnaire (QOLHEQ). Methods: The QOLHEQ was assessed up to three times in n = 316 HE patients. To explore construct validity we additionally assessed dermatology-specific (Dermatology Life Quality Index (DLQI) and Skindex-17) and generic (EuroQol -5 Dimensions (EQ -5D) HRQOL-instruments, a physician global assessment (PGA) of the HE and the disease severity as rated by the patient. The psychometric properties of the QOLHEQ were assessed using the Rasch model for each of the four subscales (symptoms, emotions, functioning and treatment/prevention) and a structural equation model to confirm the multi-dimensional structure of the QOLHEQ. We used several indices to test the responsiveness ofthe instrument. The analyses were done using AMOS 20, SPSS 20 and Rumm2030, Results: The study population was aged18 to 81 years (Mean: 46.7, SD 12.9), 45.9% were males. The PGA was normally distributed across the sample. After minor adaptations in the coding of two items all four subscales showed neither violations nor significant misfit to the Rasch model. The data revealed also a good fit to the structural equation model with HRQOL as primary construct and the four subscales as 2nd order factors. As expected the QOLHEQ showed a strong correlation with the dermatology-specific instruments (DLQI: r = 0.75 Skindex-17: r = 0.85) and a medium correlation with the EQ-5D (r =-0.51), the PGA (r = 0.34) and the disease severity reported by the patient (r = 0.59). The sensitivity to change of the QOLHEQ was superior compared with the other HRQOL-instruments as indicated by various responsiveness indices. Discussion: We have successfully developed and validated a diseases-specific HRQOL-instrument for HE. The QOLHEQ consists of 30 items assessing four relevant domains of HRQOL in HE patients and is ready to use in the German version. It's psychometric properties and responsiveness make it superior in assessing HRQOL in HE patients compared to other skin-disease specific or generic instruments. Other language versions (English, Danish, Finish, Japanese, Swedish and Turkish) will be available soon enabling scientists to compare their HRQOL data across countries.