Jart A. F. Oosterhaven

Systematic review of cost-of-illness studies in hand eczema

The individual burden of disease in hand eczema patients is considerable. However, little is known about the socio‐economic impact of this disease. The aims of this review were to evaluate the literature on cost‐of‐illness in hand eczema, and to compose a checklist for future use. The literature was retrieved from the MEDLINE and EMBASE databases up to October 2015. Quality evaluation was based on seven relevant items in cost‐of‐illness studies. Cost data (direct and indirect) were extracted and converted into euros (2014 price level) by use of the Dutch Consumer Price Index. Six articles were included. The mean annual total cost per patient ranged from €1712 to €9792 (direct cost per patient, €521 to €3829; and indirect cost per patient, €100 to €6846). Occupational hand eczema patients showed indirect costs up to 70% of total costs, mainly because of absenteeism. A large diversity in hand eczema severity was found between studies. The socio‐economic burden of hand eczema is considerable, especially for more severe and/or occupational hand eczema. Absenteeism from paid work leads to a high total cost‐of‐illness, although disregard of presenteeism often leads to underestimation of indirect costs. Differences in included cost components, the occupational status of patients and hand eczema severity make international comparison difficult. A checklist was added to standardize the approach to cost‐of‐illness studies in hand eczema.

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.

Is there an increased risk of cervical neoplasia in atopic dermatitis patients treated with oral immunosuppressive drugs

Oral immunosuppressive drugs are frequently prescribed in young women with atopic dermatitis (AD). Immunocompromised patients may have a higher risk of developing high‐risk HPV infections, cervical intra‐epithelial neoplasia (CIN) and cervical carcinoma. Most literature on patients using oral immunosuppressive drugs is available in organ transplant patients. Literature on the risk of developing cervical carcinoma in AD patients treated with oral immunosuppressive drugs is lacking. At this moment, there is no clear guideline/consensus on this topic, but in daily practice, questions arise concerning whether this risk is increased and whether more intensive screening in women using immunosuppressive drugs should take place.

Azathioprine treatment and drug survival in patients with chronic hand eczema - results from daily practice

We retrospectively reviewed patient records between January 2000 and 16 December 2015 (data lock). Patients were identified according to the International Classification of Disease (10th edition) diagnoses L20, L23-25, and L30. We included adult patients with severe chronic hand eczema who were treated with azathioprine. Patients with concomitant mild atopic dermatitis on other body areas were also included.

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.

Presenteeism in a Dutch hand eczema population-a cross-sectional survey.

Presenteeism (attending work despite complaints and ill health, which should prompt rest and absence) has been overlooked in the field of hand eczema.

A pilot comparing ultraviolet modalities for hand eczema : Shedding light on feasibility

general anaesthetic, surgical placement of a permanent device that can erode fragile skin, ongoing maintenance and a significant adjustment in body image. Is it worthwhile? The systematic review in the current issue of the British Journal of Dermatology by Zidorio et al. addresses this question. Evaluation of therapy in this complex, heterogeneous, rare disease is difficult. There are no randomized controlled trials of GTT in EB: the seven suitable studies selected from a literature trawl of 641 were case series. Most involved children with RDEB and the authors included only studies providing anthropometric data and patientor carer-reported outcomes. They conclude that nutritional status usually, but not always, improves. Interestingly, some patients report better life quality even when growth parameters have worsened, perhaps reflecting the extreme burden of maintaining oral intake. Effects on skin blistering, healing and activity levels are hard to quantify and are rarely documented. Complications led to GTT removal in 10% of patients. Unanswered questions include optimum diet and timing: should it be placed before or after malnutrition becomes a problem? Surgical technique was not covered in this review, so failed procedures and immediate complications would not have been picked up. Endoscopic GTT placement risks mucosal damage, while placement via a laparotomy is invasive and likely to be complicated by chronic leakage. A laparoscopic approach has been used successfully. Professionals managing EB need to share experience and collect consistent data on procedures, complications, nutritional status and EB-related quality of life. This can be achieved only if those managing patients with EB consult with expert centres, which in turn should collaborate. The organizations Debra International and EBClinet are leading the way in developing clinical practice guidelines. The U.K. has the unique advantage of a National Health Service and national Highly Specialized Service for EB: four of the seven studies came from U.K. centres but even these were not ideal. The newly established European Reference Network for Rare and Low Prevalence Complex Disease, with a specific sub-thematic group for EB, offers exciting opportunities for collaborative research, which patients and professionals sorely need.

Interpretability in atopic dermatitis: all about the anchor

algorithm-based’ diagnosis of HS, and the sociodemographic characteristics and comorbidities of the ‘validated algorithmbased’ HS population were consistent with previous studies, minimizing classification bias. Finally, the authors should be congratulated for the robustness of their study in terms of its design, opening a new methodological avenue in the pharmacoepidemiology field, where diagnostic criteria are lacking. This study confirmed that the prevalence of HS is not more than 0 7–1%.

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

Introduction Systemic 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. Cyclosporine A (cyclosporine) is prescribed for hand eczema in daily practice as well. It has shown to be particularly effective in patients with vesicular hand eczema. The primary objective of this study is to compare efficacy of alitretinoin and cyclosporine in the treatment of severe recurrent vesicular hand eczema. Methods and analysis This is an investigator-initiated randomised prospective open-label trial with blinded outcome assessment. Severity assessments and laboratory measurements will be conducted corresponding to daily practice. The study population will consist of 72 adult patients (age 18–75 years) with severe recurrent vesicular hand eczema. Patients are treated with either (group I) alitretinoin 30 mg once daily or (group II) cyclosporine with a starting dose of 5 mg/kg/day and a decrease in dosage after 8 weeks to 3–3.5 mg/kg/day. The treatment period is 24 weeks for both drugs. Primary endpoint for efficacy is response to treatment, defined as an improvement of ≥2 steps on a Physician Global Assessment, using a validated Photoguide, after 24 weeks of treatment. Secondary endpoints are improvement of Hand Eczema Severity Index, Quality of Life in Hand Eczema Questionnaire and a Patient Global Assessment. Adverse events and time to response will be registered. Furthermore, cost-utility, quality-adjusted life years and cost-effectiveness will be assessed with the EQ-5D-5L questionnaire while monitoring costs. Ethics and dissemination This protocol was reviewed and approved by the Medical Ethical Review Board of the University Medical Centre Groningen (reference METc 2015/375). The study will be conducted according to the principles of the Declaration of Helsinki, in accordance with the Dutch Medical Research Involving Human Subjects Act. Trial registration number NCT03026946; Pre-results.

Results of patch testing in Indonesian shoe factory workers

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