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Background: Hand eczema (HE) is a common skin disease characterized by itch, pain and visible skin changes such as fissures, erythema and vesicles. It is not yet clear which outcome domains are most important for patients. The Hand Eczema Core Outcome Set (HECOS) initiative is developing a consented set of core domains and suitable measurement instruments for the future application in all HE trials. This includes an online Delphi survey about core domains, which requires a ‘Long List’ of all domains that might be important to measure. Objectives: To compile a ‘Long List’ of candidate outcome domains for therapeutic HE trials with suggestions from patients and experts. Methods: First, 60 patients with chronic HE were interviewed at seven study sites in Croatia, Denmark, Germany, the Netherlands and Spain. Patients were asked about domains that were important from their perspectives. Second, 185 HE experts were invited by email to complete an online survey. With an open question, they were asked to suggest up to six domains. Results: Suggestions were provided by 58 patients and 82 experts. Most patients and experts suggested to measure the domains ‘signs’, ‘symptoms’ and ‘HE-related quality of life’. Specifically, >25% of patients said that less itch, pain or fissures indicated a successful treatment. Among experts, >25% suggested ‘itch’ and ‘ability to work’ as core sub-domains. Further outcomes from the domains ‘HE control over time’, ‘patient-reported treatment experience’ and ‘skin barrier function’ were mentioned. Conclusion: ‘Itch’ was rated high among patients with HE and professional HE experts. While patients emphasized fissures as important, experts underlined the ability to work. This investigation allowed us to define a ‘Long List’ of 7 candidate outcome domains with 58 sub-domains. From this list, a panel of stakeholders will select core domains during an online Delphi survey.

Linked Article: Langbroek et al. Br J Dermatol 2022; 187:730–742.

With more than 200,000 new cases per year, skin tumours have been the most frequently reported cancers in Germany for years. We performed a systematic review to summarise the current evidence concerning the preventive value of regular sunscreen use.Systematic literature review of controlled and randomised controlled trials were performed in Ovid Embase and Ovid Medline on 21 January 2020. We included studies evaluating the effectiveness of sunscreens on epithelial skin cancer, actinic keratosis or photoageing, or side effects in humans.Five eligible trials, each involving 28 to 1,621 participants from various populations, were identified. All 4 studies on actinic keratoses showed a significant beneficial effect of sunscreens. The 2 studies on squamous cell carcinoma demonstrated significant beneficial effects of sunscreens. The 2 studies on photoageing observed a significant reduction in the sunscreen groups. The 2 studies on basal cell carcinoma reported no significant results, but both studies reported some non-significant protective effects of sunscreen use. Sunscreens as well as vehicles sometimes had side effects affecting skin and eyes. Compared with controls, sunscreens had no significant side effects on vitamin D, bone mass density and mortality.The evidence from published controlled and randomised controlled studies is limited. Especially for basal cell carcinoma, further high-quality studies including young populations are required to investigate possible protective effects of modern broad-spectrum sunscreens. The results of this systematic review do not change the current recommendations for UV protection. Sunscreens are recommended as a second-line measure against solar radiation whenever protective clothing and seeking shake are inadequate.

Um die Aussagekraft und Vergleichbarkeit von Handekzemstudien zu verbessern, ist die Konsentierung eines Core-Outcome-Sets notwendig. Wie werden Therapie- oder Praventionserfolg in Handekzemstudien derzeit erfasst? Welcher Standard soll dafur in Zukunft gelten? Als erster Schritt beschreibt ein systematischer Literaturreview die Ausgangssituation 2000 bis 2017 in kontrollierten und randomisiert kontrollierten Handekzemstudien und identifiziert die verwendeten Outcomes. Die Hand Eczema Core Outcome Set Initiative (HECOS) folgt den Richtlinien der Cochrane Skin Group Core Outcome Set Initiative (CS-COUSIN) und wird somit im weiteren Verlauf sicherstellen, dass die Perspektiven von Patienten, Arzten und Forschern angemessen berucksichtigt werden und dass die vorgeschlagenen Erfassungsinstrumente valide sind. Bisherige Studien bestimmten uberwiegend die Auspragung von Erythem, Schuppung, Fissuren, Vesikeln oder Pruritus als klinische Zeichen und Symptome des Handekzems. Die dazu erhobenen Daten wurden meist nicht separat publiziert, sondern flossen in eine Vielzahl von Scores ein. Nur wenige Handekzemscores wurden in mehr als einer Studie verwendet – am haufigsten kam der Hand Eczema Severity Index (HECSI) zum Einsatz (in 10 % der Studien); 51 % der Studien bewerteten den Hautzustand allgemein, also ohne expliziten Ruckgriff auf konkrete klinische Zeichen oder Symptome. Obwohl bestimmte klinische Zeichen und Symptome in der Mehrheit der Studien erfasst wurden, ist eine Vergleichbarkeit der Ergebnisse nicht gewahrleistet, weil unterschiedliche Erfassungsinstrumente verwendet wurden. HECOS wird fur zukunftige Handekzemforschung ein Set von relevanten und validierten Erfassungsinstrumenten konsentieren.

The considerable heterogeneity of outcomes and measurement instruments in hand eczema trials substantially limits the evidence synthesis concerning therapeutic and preventive interventions. Therefore, the Hand Eczema Core Outcome Set (HECOS) initiative is developing a core outcome set for future trials. The first objective was to identify outcomes that were measured in previous trials, to group them in domains, and to identify their measurement instruments. We conducted a systematic review of controlled and randomized controlled hand eczema trials published since 2000. Sixty-one eligible studies were identified. Each assessed one or more of 47 outcomes in the "skin" domain. Eighteen trials (30%) additionally focused on preventive behaviour in risk occupations. Quality of life was measured in 13 studies (21%). Thirty-two distinct named instruments were applied, but 223 measurements (62%) were conducted with unnamed instruments. Only 32 studies (52%) defined a primary outcome. Twenty-nine trials (48%) provided some information on adverse events, but none gave any references concerning relevant methods. Our review confirms the need to harmonize outcome measurements in hand eczema trials. The findings form the basis for a consensus process to generate a core outcome set to improve the explanatory power and comparability of future hand eczema studies.

Background With more than 200,000 new cases per year, skin tumours have been the most frequently reported cancers in Germany for years. We performed a systematic review to summarise the current evidence concerning the preventive value of regular sunscreen use. Methods Systematic literature review of controlled and randomised controlled trials were performed in Ovid Embase and Ovid Medline on 21 January 2020. We included studies evaluating the effectiveness of sunscreens on epithelial skin cancer, actinic keratosis or photoageing, or side effects in humans. Results Five eligible trials, each involving 28 to 1,621 participants from various populations, were identified. All 4 studies on actinic keratoses showed a significant beneficial effect of sunscreens. The 2 studies on squamous cell carcinoma demonstrated significant beneficial effects of sunscreens. The 2 studies on photoageing observed a significant reduction in the sunscreen groups. The 2 studies on basal cell carcinoma reported no significant results, but both studies reported some non-significant protective effects of sunscreen use. Sunscreens as well as vehicles sometimes had side effects affecting skin and eyes. Compared with controls, sunscreens had no significant side effects on vitamin D, bone mass density and mortality. Conclusion The evidence from published controlled and randomised controlled studies is limited. Especially for basal cell carcinoma, further high-quality studies including young populations are required to investigate possible protective effects of modern broad-spectrum sunscreens. The results of this systematic review do not change the current recommendations for UV protection. Sunscreens are recommended as a second-line measure against solar radiation whenever protective clothing and seeking shake are inadequate.

Background Clinical hand eczema trials measure a variety of outcome domains to determine the success of interventions. This considerably limits the comparability and overall confidence in the study results, and thereby the strength of recommendations for clinical practice. Objectives The Hand Eczema Core Outcome Set (HECOS) initiative aims to develop a core outcome set (COS) for the standardized evaluation of interventions in future hand eczema trials and reviews. This COS will define the minimum that should be measured and reported in controlled and randomized-controlled trials of therapeutic hand eczema interventions. The objective of this protocol is to specify the methods to develop a core domain set. Methods In Phase 1, a list of candidate domains will be derived from a systematic literature review concerning previously measured outcomes in hand eczema trials, from qualitative patient interviews and from expert interviews. In Phase 2, a consensus study about core domains will be conducted by an online 3-round Delphi survey and a face-to-face meeting, applying predefined consensus criteria. HECOS involves hand eczema and methods experts as well as patients and further stakeholders with an interest in the initiative. Outlook When a set of core domains has been defined, HECOS is going to identify appropriate outcome measurement instruments in a development process that will be detailed in another protocol. The COS will considerably enhance the methodological quality, comparability and usefulness of hand eczema trials for clinical decision-making and the development of new therapeutic options for hand eczema, and also reduce the effort of planning, conducting, and reporting individual hand eczema studies, reviews and meta-analyses.

Background and objectives Patients with chronic urticaria are often unsatisfied with their treatment. We aimed to assess patient satisfaction, chronic urticaria control, treatment goals, self-treatment competence, knowledge, and factors influencing treatment satisfaction. Patients and methods Eighty-seven adult patients with chronic urticaria who were previously insufficiently treated with oral antihistamines received guideline-based care for six months and completed questionnaires. Results This study included patients with chronic spontaneous (80 %) and/or inducible urticaria (CIndU, 32 %). Significant median improvements were observed with the urticaria control test (UCT, from 7 to 11), the urticaria activity score for patients with chronic spontaneous urticaria (from 19 to 10), and treatment satisfaction (from 5.2 to 8.4). Six significant, independent factors of treatment satisfaction after six months of treatment were identified (negative: male sex, CIndU, sleep disturbances; positive: UCT, baseline treatment satisfaction, perceived competence of the study physician). Adequate urticaria control (UCT ≥ 12) was achieved in 19 % of patients with CIndU and 61 % of patients without CIndU. Conclusions In patients with chronic urticaria who were previously insufficiently treated with antihistamines, six months of guideline-based therapy significantly improved disease control and treatment satisfaction. Adequate control requires several consultations for many patients and is considerably more difficult to achieve for CIndU.

Background Safety and tolerability of venom immunotherapy (VIT) in patients with concomitant disease and comedications, especially β-blockers (BBs) and angiotensin-converting enzyme inhibitors (ACEIs), are under discussion. Objective To identify risk factors for the occurrence of systemic reactions (SRs) during the build-up phase of a 3-day rush VIT with focus on comorbidities and related comedications. Methods Data of 175 three-day rush VIT courses ( Vespula venom, n = 161; honeybee venom, n = 14) were analyzed. Starting with 0.02 μg of venom, the maintenance dose of 100 μg was reached in 15-dose increments within 3 days. Local reactions (LRs) and SRs were documented during the build-up phase. Comorbidities and related comedications were registered. Univariate, bivariate, and multivariate data analysis was performed. Results During the 3-day rush VIT, an LR was seen in 74 (42.3%) of 175, a large LR (>10-cm diameter) in 82 (46.9%) of 175, and SRs in 19 (10.9%) of 175 VIT courses. Multivariate logistic regression revealed that female sex ( P = .01), immunotherapy with honeybee venom ( P = .003), and accompanying ACEI medication ( P = .03) were independent predictors of the development of SRs during the build-up phase of VIT. Conclusion This study revealed that female sex, honeybee VIT, and ACEI use independent predictors for SRs.

The most important but influenceable risk factor in the development of skin cancer is the unprotected exposure to solar ultraviolet (UV) radiation. In order to assure adequate and effective protection against UV exposure, a level of knowledge about solar radiation and its effects is required. The objective of this study was to assess the knowledge of workers in outdoor professions on the effects of natural UV radiation and methods of protection against exposure. Forty outdoor workers were given a standardized questionnaire designed to ascertain their level of knowledge. The majority of participants knew exposure to solar radiation can be detrimental depending on exposure time. Eighty-three percentage recognized that people working regularly in an outdoor environment may be at risk due to high exposure. Long-sleeved clothing plus headgear and sunscreen containing sun-protecting substances were deemed adequate methods of protection by 83% and 85% respectively. Seventy percentage of the outdoor workers were familiar with the definition of the sun protection factor (SPF), yet only 25% correctly identified the amount of sunscreen needed to achieve the SPF as indicated on the product. A mere 8% of participants knew that symptoms of a sunburn first became apparent 3 h after sun exposure and only 18% were able to accurately gauge the amount of time they could spend in the sun before developing one. Although 30% had heard of the ultraviolet index (UVI), only 13% understood that protecting your skin using additional measures is recommended as of UVI 3. Overall, 30% of the outdoor workers thought themselves sufficiently protected against the harmful effects of the sun. While the participants of this study had a basic fundamental understanding of the effects of solar radiation and methods of protection against exposure, there remains an urgent need for further clarification across all demographic groups.

Adequate sun protection is often neglected during occupational outdoor work. To investigate the acceptance and usability of sunscreens during outdoor work a singleblind, randomized-controlled, cross-over trial was performed in 40 subjects. Two sunscreen formulations were used daily on working days for 4 weeks at a time, with a wash-out phase before crossover. The primary outcome was overall acceptance of the products with daily application. More than 80% of the outdoor workers were fully satisfied with the cosmetic properties, sweat resistance, performance and usability of both products under outdoor working conditions. With respect to overall performance, the milk was rated slightly better than the gel. In terms of ease of application, the milk was preferred (p < 0.05). Sunscreens for those working outdoors must contain very high, broad-spectrum, photostable filters for both UVB and UVA, they must be easy to apply and sweat resistant, and should not irritate the eyes. Key words: sun protection; outdoor work; sunscreen; acceptance; usability.

BACKGROUND: Occupational irritant hand dermatitis (OIHD) causes significant functional impairment, disruption of work, and discomfort in the working population. Different preventive measures such as protective gloves, barrier creams and moisturisers can be used, but it is not clear how effective these are. This is an update of a Cochrane review which was previously published in 2010. OBJECTIVES: To assess the effects of primary preventive interventions and strategies (physical and behavioural) for preventing OIHD in healthy people (who have no hand dermatitis) who work in occupations where the skin is at risk of damage due to contact with water, detergents, chemicals or other irritants, or from wearing gloves. SEARCH METHODS: We updated our searches of the following databases to January 2018: the Cochrane Skin Specialised Register, CENTRAL, MEDLlNE, and Embase. We also searched five trials registers and checked the bibliographies of included studies for further references to relevant trials. We handsearched two sets of conference proceedings. SELECTION CRITERIA: We included parallel and cross‐over randomised controlled trials (RCTs) which examined the effectiveness of barrier creams, moisturisers, gloves, or educational interventions compared to no intervention for the primary prevention of OIHD under field conditions. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. The primary outcomes were signs and symptoms of OIHD developed during the trials, and the frequency of treatment discontinuation due to adverse effects. MAIN RESULTS: We included nine RCTs involving 2888 participants without occupational irritant hand dermatitis (OIHD) at baseline. Six studies, including 1533 participants, investigated the effects of barrier creams, moisturisers, or both. Three studies, including 1355 participants, assessed the effectiveness of skin protection education on the prevention of OIHD. No studies were eligible that investigated the effects of protective gloves. Among each type of intervention, there was heterogeneity concerning the criteria for assessing signs and symptoms of OIHD, the products, and the occupations. Selection bias, performance bias, and reporting bias were generally unclear across all studies. The risk of detection bias was low in five studies and high in one study. The risk of other biases was low in four studies and high in two studies. The eligible trials involved a variety of participants, including: metal workers exposed to cutting fluids, dye and print factory workers, gut cleaners in swine slaughterhouses, cleaners and kitchen workers, nurse apprentices, hospital employees handling irritants, and hairdressing apprentices. All studies were undertaken at the respective work places. Study duration ranged from four weeks to three years. The participants' ages ranged from 16 to 67 years. Meta‐analyses for barrier creams, moisturisers, a combination of both barrier creams and moisturisers, or skin protection education showed imprecise effects favouring the intervention. Twenty‐nine per cent of participants who applied barrier creams developed signs of OIHD, compared to 33% of the controls, so the risk may be slightly reduced with this measure (risk ratio (RR) 0.87, 95% confidence interval (CI) 0.72 to 1.06; 999 participants; 4 studies; low‐quality evidence). However, this risk reduction may not be clinically important. There may be a clinically important protective effect with the use of moisturisers: in the intervention groups, 13% of participants developed symptoms of OIHD compared to 19% of the controls (RR 0.71, 95% CI 0.46 to 1.09; 507 participants; 3 studies; low‐quality evidence). Likewise, there may be a clinically important protective effect from using a combination of barrier creams and moisturisers: 8% of participants in the intervention group developed signs of OIHD, compared to 13% of the controls (RR 0.68, 95% CI 0.33 to 1.42; 474 participants; 2 studies; low‐quality evidence). We are uncertain whether skin protection education reduces the risk of developing signs of OIHD (RR 0.76, 95% CI 0.54 to 1.08; 1355 participants; 3 studies; very low‐quality evidence). Twenty‐one per cent of participants who received skin protection education developed signs of OIHD, compared to 28% of the controls. None of the studies addressed the frequency of treatment discontinuation due to adverse effects of the products directly. However, in three studies of barrier creams, the reasons for withdrawal from the studies were unrelated to adverse effects. Likewise, in one study of moisturisers plus barrier creams, and in one study of skin protection education, reasons for dropout were unrelated to adverse effects. The remaining studies (one to two in each comparison) reported dropouts without stating how many of them may have been due to adverse reactions to the interventions. We judged the quality of this evidence as moderate, due to the indirectness of the results. The investigated interventions to prevent OIHD probably cause few or no serious adverse effects. AUTHORS' CONCLUSIONS: Moisturisers used alone or in combination with barrier creams may result in a clinically important protective effect, either in the long‐ or short‐term, for the primary prevention of OIHD. Barrier creams alone may have slight protective effect, but this does not appear to be clinically important. The results for all of these comparisons were imprecise, and the low quality of the evidence means that our confidence in the effect estimates is limited. For skin protection education, the results varied substantially across the trials, the effect was imprecise, and the pooled risk reduction was not large enough to be clinically important. The very low quality of the evidence means that we are unsure as to whether skin protection education reduces the risk of developing OIHD. The interventions probably cause few or no serious adverse effects. We conclude that at present there is insufficient evidence to confidently assess the effectiveness of interventions used in the primary prevention of OIHD. This does not necessarily mean that current measures are ineffective. Even though the update of this review included larger studies of reasonable quality, there is still a need for trials which apply standardised measures for the detection of OIHD in order to determine the effectiveness of the different prevention strategies.