Effectiveness of a standardized skin care regimen to prevent atopic dermatitis in infants at risk for atopy: a randomized, pragmatic, parallel-group study.

BACKGROUND: It has been proposed that regular emollient application in early life could enhance skin barrier function and prevent atopic dermatitis (AD) especially in predisposed infants. This hypothesis was supported by evidence from exploratory and pilot trials showing protective effects in terms of reduced cumulative atopic dermatitis incidence with the use of daily emollient therapy starting immediately after birth. OBJECTIVES: To investigate the effectiveness of a standardized skin care regimen for infants on the development of AD compared to not structured skin care regimen in infants with atopic predisposition. METHODS: Prospective, parallel group, randomized, pragmatic, investigator-blinded intervention trial including 160 infants with 52 weeks intervention and 52 weeks follow up phase up to the age of two years. Infants were randomly assigned to receive a standardized skin care regimen including once daily leave-on product application (lipid content 21%) or skin care as preferred by the parents. RESULTS: Using the intention to treat approach, the cumulative AD incidence was 10.6% after one year, and 19.5% after two years in the total sample. There were no statistical significant differences between intervention and control groups. Skin barrier parameters between the intervention and control groups were comparable. AD severity was higher and quality of life was more affected in the control group. CONCLUSIONS: Regular emollient application during the first year of life does not prevent the development of atopic dermatitis. A standardized skin care regimen does not delay skin barrier development or causes side effects.

Epidermal thickness in healthy humans: a systematic review and meta-analysis.

Several skin diseases are characterized by epidermal alterations affecting epidermal thickness. Reference values of epidermal thickness in healthy humans and knowledge of possible differences regarding age, sex, skin phototype, and ethnic origin are essential in research and in clinical practice. The objectives of this systematic review were to provide epidermal thickness reference values for healthy human skin and describe possible effects of measurement methods, age, sex, ethnic origin, and skin phototype. A combined search in the databases Medline and Embase, and other sources were conducted. Searches covered a period from 1946 to 3 June 2020. Included studies were primarily observational and interventional studies providing means and spread values of epidermal thickness estimates in healthy humans, with clear reporting of skin area, age, and measurement method, and optional reporting of sex, ethnic origin, and skin phototype. Data were extracted per skin area and pooled in random-effects models. A total of 142 studies were included in the qualitative synthesis and 133 in the meta-analysis. Pooled epidermal thickness estimates were calculated for 37 skin areas. The lowest epidermal thickness of 31.2 (95% CI 27.8-34.6) µm was reported for the penis and the highest of 596.6 (95% CI 443.9-749.3) µm for the plantar aspect of the foot. Differences in epidermal thickness estimates obtained by histology, optical coherence tomography, and laser scanning microscopy were minor. High-frequency ultrasonography produces systematically higher values. The epidermis was thinner in aged skin. Differences between sexes and among ethnic origins were minor. Epidermal thickness reference values are provided for 37 skin areas. In conclusion, the epidermis tends to become thinner by ageing and does not seem to be influenced by sex. Histology, optical coherence tomography, and laser scanning microscopy might be used interchangeably to measure epidermal thickness, whereas high-frequency ultrasound should not be used.

Development of an international core domain set for medium, large and giant congenital melanocytic naevi as a first step towards a core outcome set for clinical practice and research.

BACKGROUND: Medium, large and giant congenital melanocytic naevi (CMN) can impose a psychosocial burden on patients and families, and are associated with increased risk of developing melanoma or neurological symptoms. Lack of consensus on what outcomes to measure makes it difficult to advise patients and families about treatment and to set up best practice for CMN. OBJECTIVES: Fostering consensus among patient representatives and professionals, we aim to develop a core outcome set, defined as the minimum set of outcomes to measure and report in care and all clinical trials of a specific health condition. We focused on the 'what to measure' aspect, the so-called core domain set (CDS), following the COMET and CS-COUSIN guidelines. METHODS: We conducted a systematic review to identify outcomes reported in the literature. Focus groups with patient representatives identified patient-reported outcomes. All these outcomes were classified into domains. Through e-Delphi surveys, 144 stakeholders from 27 countries iteratively rated the importance of domains and outcomes. An online consensus meeting attended by seven patient representatives and seven professionals finalized the CDS. RESULTS: We reached consensus on six domains, four of which were applied to both care and research: 'quality of life', 'neoplasms', 'nervous system' and 'anatomy of skin'. 'Adverse events' was specific to care and 'pathology' to research. CONCLUSIONS: We have developed a CDS for medium-to-giant CMN. Its application in reporting care and research of CMN will facilitate treatment comparisons. The next step will be to reach consensus on the specific outcomes for each of the domains and what instruments should be used to measure these domains and outcomes.

Outcomes for Pressure Ulcer Trials (OUTPUTs) project: review and classification of outcomes reported in pressure ulcer prevention research.

In order to overcome inconsistencies in the reporting of outcomes in clinical trials, core outcome sets (COSs) have been developed in many clinical areas and the awareness of this concept is growing steadily. The Outcomes for Pressure Ulcer Trials (OUTPUTs) project aims to improve the quality of evidence from pressure ulcer prevention trials by developing a COS. As an initial step in the COS process we aimed to identify and classify both outcomes and concepts that represent potential outcomes for future trials that have been reported in pressure ulcer prevention research. A review was conducted in 12 major databases covering the literature indexed until 2016. Outcomes and relevant concepts reported in primary studies and/or reviews on pressure ulcer prevention in adult patients were extracted as presented in the articles, and afterwards inductively grouped into outcome domains. The domains were then categorized according to the outcome domain taxonomy recently proposed by the COMET group. In total 332 studies were included and 68 outcome domains were identified, covering multiple aspects of pressure ulcer prevention. Pressure ulcer occurrence was reported in 71% of all included studies, representing the most frequent outcome, followed by costs (22% of all studies) and acceptability of intervention and comfort (18% of all studies). A plethora of different outcomes are applied in pressure ulcer prevention research and substantial variations in definitions and reporting of similar outcomes were observed. A COS for pressure ulcer prevention trials is needed to overcome the noncomparability of outcomes.

Outcome assessment in dermatology clinical trials and cochrane reviews: call for a dermatology-specific outcome taxonomy.

BACKGROUND: Standardized outcome reporting is crucial for trial evidence synthesis and translation of findings into clinical decision-making. The OMERACT 2.0 Filter and COMET outcome domain taxonomy propose frameworks for consistent reporting of outcomes. There is an absence of a uniform dermatology-specific reporting strategy that uses precise and consistent outcome definitions. OBJECTIVES: Our aim was to map efficacy/effectiveness outcomes assessed in dermatological trials to the OMERACT 2.0 Filter as a starting point for developing an outcome taxonomy in dermatology. METHODS: We critically appraised 10 Cochrane Skin Reviews randomly selected from all 69 Cochrane Skin Reviews published until 01/2015 and the 220 trials included covering a broad spectrum of dermatological conditions and interventions. Efficacy/effectiveness outcomes were mapped to core areas and domains according to the OMERACT 2.0 Filter. The extracted trial outcomes were used for critical appraisal of outcome reporting in dermatology trials and for the preliminary development of a dermatology-specific outcome taxonomy. RESULTS: The allocation of 1086 extracted efficacy/effectiveness outcomes to the OMERACT 2.0 Filter resulted in a hierarchically structured dermatology-specific outcome classification. In 506 outcomes (47%), the outcome concept to be measured was insufficiently described, hindering meaningful evidence synthesis. Although the core areas assessed in different dermatology trials of the same condition overlap considerably, quantitative evidence synthesis usually failed due to imprecise outcome definitions, non-comparable outcome measurement instruments, metrics and reporting. CONCLUSIONS: We present an efficacy/effectiveness outcome classification as a starting point for a dermatology-specific taxonomy to provide trialists and reviewers with the opportunity to better synthesize and compare evidence.

Maintaining skin integrity in the aged: A systematic review.

BACKGROUND: In aged nursing care receivers, the prevalence of adverse skin conditions such as xerosis cutis, intertrigo, pressure ulcers or skin tears is high. Adequate skin care strategies are an effective method for maintaining and enhancing skin health and integrity in this population. OBJECTIVES: The objective was to summarize the empirical evidence about the effects and effectiveness of non-drug topical skin care interventions to promote and to maintain skin integrity and skin barrier function in the aged, to identify outcome domains and outcome measurement instruments in this field. DESIGN: An update of a previous systematic review published in 2013 was conducted. DATA SOURCES: Databases MEDLINE and EMBASE via OvidSP and CINAHL (original search January 1990 to August 2012, update September 2012 to May 2018) and reference lists were searched. Forward searches in Web of Science were conducted. METHODS: A review protocol was registered in Prospero (CRD42018100792). Main inclusion criteria were primary intervention studies reporting treatment effects of basic skin care strategies in aged people with a lower limit of age range of 50 years and published between 1990 and 2018. Primary empirical studies were included with experimental study designs including randomized controlled trials and quasi-experimental designs. Methodological quality of included randomized controlled trials was evaluated using the Cochrane Collaboration's Tool for assessing risk of bias. Levels of evidence were assigned to all included studies. RESULTS: Sixty-three articles were included in the final analysis reporting effects of interventions to treat and/or to prevent skin dryness, pruritus, general skin barrier improvement, incontinence-associated dermatitis, skin tears and pressure ulcers. Skin cleansers containing syndets or amphotheric surfactants compared with standard soap and water improved skin dryness. Lipophilic leave-on products containing humectants decreased skin dryness and reduced pruritus. Products with pH 4 improved the skin barrier. Application of skin protectants and structured skin care protocols decreased the severity of incontinence-associated dermatitis. Formulations containing glycerin and petrolatum reduced the incidence of skin tears. Thirty-five outcome domains were identified with nearly 100 different outcome measurement instruments. CONCLUSION: Included studies showed substantial heterogeneity regarding design, interventions and outcomes. Basic skin care strategies including low-irritating cleansers and lipophilic humectant-containing leave-on products are helpful for treating dry skin and improving skin barrier in the aged. Lower pH of leave-on products improves the skin barrier. The number of different outcome domains was unexpectedly high. We recommend to identify critical outcome domains in the field of skin care to make trial results more comparable in the future and to measure possible performance differences between different skin care strategies and products.

[Incontinence-associated dermatitis: a position paper]. / Inkontinenzassoziierte Dermatitis: ein Positionspapier.

Incontinence-associated dermatitis (IAD) describes damage to the skin caused by repeated and prolonged contact with urine and/or feces. Patients of all ages can be affected; the diagnosis is preferably used in adults and adolescents. The predilection sites are perineal, perianal, the inner thighs and the convex areas of the buttocks. Increased moisture on the skin surface, increased pH, occlusion, feces digestive enzymes and repeated skin cleansing procedures are pathophysiologically relevant factors. Typical clinical signs of IAD are erythema, erosions, excoriations and pain. Diagnosis is often difficult because there are many relevant differential diagnoses, some of which may occur together with an IAD. In particular, pressure ulcer, contact dermatitis and intertrigo need to be differentiated and treated. Effective strategies of prevention and therapy of IAD are continence management, the use of efficient, absorbent products as well as consistent skin protection and care. IAD is a skin disease that is often not or incorrectly diagnosed. It should be treated as early as possible, together with the causative factors such a fecal and/or urinary incontinence, as otherwise it can lead to an unnecessarily long duration and severity of the symptoms.

The effectiveness of two silicone dressings for sacral and heel pressure ulcer prevention compared with no dressings in high-risk intensive care unit patients: a randomized controlled parallel-group trial.

BACKGROUND: There is a high incidence of pressure ulcers in high-risk settings such as intensive care. There is emerging evidence that the application of dressings to pressure ulcer predilection areas (sacrum and heels) improves prevention strategies. OBJECTIVES: To determine whether preventive dressings, applied to the sacrum and heels of high-risk patients in intensive care units, in addition to standard prevention, reduces the incidence of pressure ulcers. METHODS: Between June 2015 and July 2018, a randomized, controlled, two-arm, superiority pragmatic study was performed with a concealed 1 : 1 allocation to the intervention and control group. Patients assigned to the intervention group had dressings applied to the sacrum and heels. RESULTS: In total, 7575 patients were screened for eligibility and 475 patients were included and allocated to both groups. Finally, 212 patients in the intervention group and 210 in the control group were analysed. The mean age was 63·5 years and the majority of patients were male (65·4%). The cumulative pressure ulcer incidence category II and above was 2·8% in the intervention, and 10·5% in the control group (P = 0·001). Compared with the control group, the relative risk in the intervention group was 0·26 [95% confidence interval (CI) 0·11-0·62] and the absolute risk reduction was 0·08 (95% CI 0·03-0·13). CONCLUSIONS: The results indicate that the application of dressings, in addition to standard prevention, in high-risk intensive care unit patients is effective in preventing pressure ulcers at the heels and sacrum. What's already known about this topic? Pressure ulcers are severe soft tissue injuries and wounds, which occur worldwide in all healthcare settings. Despite preventive interventions, pressure ulcers still develop. There is emerging evidence that dressings help to prevent pressure ulcers. What does this study add? The incidence of pressure ulcers in intensive care units among high-risk patients remains high. The application of dressings to the sacrum and heels, in addition to standard preventive measures, reduces the relative and absolute risks for the development of pressure ulcers. The application of preventive dressings at the heels and sacrum seems to be feasible in intensive care settings.

Standardizing the classification of skin tears: validity and reliability testing of the International Skin Tear Advisory Panel Classification System in 44 countries.

BACKGROUND: Skin tears are acute wounds that are frequently misdiagnosed and under-reported. A standardized and globally adopted skin tear classification system with supporting evidence for diagnostic validity and reliability is required to allow assessment and reporting in a consistent way. OBJECTIVES: To measure the validity and reliability of the International Skin Tear Advisory Panel (ISTAP) Classification System internationally. METHODS: A multicountry study was set up to validate the content of the ISTAP Classification System through expert consultation in a two-round Delphi procedure involving 17 experts from 11 countries. An online survey including 24 skin tear photographs was conducted in a convenience sample of 1601 healthcare professionals from 44 countries to measure diagnostic accuracy, agreement, inter-rater reliability and intrarater reliability of the instrument. RESULTS: A definition for the concept of a 'skin flap' in the area of skin tears was developed and added to the initial ISTAP Classification System consisting of three skin tear types. The overall agreement with the reference standard was 0·79 [95% confidence interval (CI) 0·79-0·80] and sensitivity ranged from 0·74 (95% CI 0·73-0·75) to 0·88 (95% CI 0·87-0·88). The inter-rater reliability was 0·57 (95% CI 0·57-0·57). The Cohen's Kappa measuring intrarater reliability was 0·74 (95% CI 0·73-0·75). CONCLUSIONS: The ISTAP Classification System is supported by evidence for validity and reliability. The ISTAP Classification System should be used for systematic assessment and reporting of skin tears in clinical practice and research globally. What's already known about this topic? Skin tears are common acute wounds that are misdiagnosed and under-reported too often. A skin tear classification system is needed to standardize documentation and description for clinical practice, audit and research. What does this study add? The International Skin Tear Advisory Panel Classification System was psychometrically tested in 1601 healthcare professionals from 44 countries. Diagnostic accuracy was high when differentiating between type 1, 2 and 3 skin tears using a set of validated photographs.

Frontal fibrosing alopecia: demographic and clinical characteristics of 490 cases.

BACKGROUND: Frontal fibrosing alopecia (FFA) is a cicatricial alopecia mostly affecting the frontotemporal hairline. Its aetiology and associated factors remain unclear. OBJECTIVE AND METHODS: An observational, cross-sectional and descriptive study was conducted in France and Germany to identify demographic and health characteristics associated with the severity of FFA. RESULTS: Of 490 included patients, 95% were female, of which 84% were postmenopausal. Age at onset of FFA symptoms ranged between 15 and 89 years, but diagnosis was frequently delayed up to 24 years. Lichen Planopilaris Activity Index scores were low (median 1.8, IQR 1.0 to 3.5). Thyroid function disorders were reported in 13% of men and 35% of women. Abnormal blood lipid levels were found in 42% of tested men and 47% of women. In the bivariate analyses, LPPAI scores were negatively correlated with abnormal testosterone (rs  = -0.775) and oestrogen values (rs  = -0.664), regular use of face cleaning products (rs  = -0.465), hair colourants (rs  = -0.679) and hairspray (rs  = -0.500). CONCLUSIONS: The most common comorbidity was thyroid disease, with proportions higher than in the European population, possibly reflecting a role of thyroid hormones in FFA pathogenesis. The association of abnormal testosterone and oestrogen values with lesser disease activity needs to be explored in further studies. Our correlation analyses do not support a role of leave-on cosmetic products in the pathophysiology of FFA.

[Frequency of falls among clients of home care services : The importance of care-related and social risk factors]. / Häufigkeit von Stürzen unter Klienten ambulanter Pflegedienste : Die Bedeutung pflegerischer und sozialer Risikofaktoren.

BACKGROUND: Among the elderly falls frequently result in injuries, increase the need for long-term care and pose a challenge for the quality assurance in nursing care. We describe the frequency and risk factors of falls among care-dependent persons using home care services in Germany. METHODS: The participants of the study "Nursing-related health problems in home care" (n = 880) were recruited based on a list of the officially accredited nursing services. Data collection followed a standardized study protocol. Proportions were calculated and adjusted odds ratios and predicted probabilities were estimated using binary logistic regression. RESULTS: Falls are a frequent occurrence among care-dependent persons who are cared for by home care services: Almost every tenth care-dependent person suffers from a fall within a period of 2 weeks. Falls are mainly associated with social and care-related factors. Besides a low educational status this comprises certain living and care arrangements: People living alone or having infrequent contact to their nursing service as well as clients that, according to their carers, should receive more support have a significantly higher chance of falling. Multimorbidity is a medical risk factor while neurological diseases as well as polypharmacy present increased risks only in interaction with living and care arrangements. CONCLUSION: Nursing staff and physicians should maintain an overview of the social and health conditions of people in need of long-term care. If care-dependent persons live alone or are infrequently cared for, additional medical problems considerably increase the risk for falling; therefore, preventive interventions and follow-up assessments of actual need levels should be promptly considered if health conditions or living arrangements change.

Dry skin in home care: A representative prevalence study.

AIMS AND OBJECTIVES: To measure the prevalence and severity of dry skin in the home care nursing setting in Germany and to determine demographic and health characteristics associated with skin dryness. BACKGROUND: Advanced age and skin care dependency are risk factors for the development of skin dryness. Dry skin has a negative impact on the quality of life and increases the risk for secondary cutaneous infections and other adverse skin conditions. The prevalence of dry skin in home care is unknown. DESIGN: A representative multicenter prevalence study was conducted in home care services in Germany during July 2015. METHODS: A random selection of home care services and clients was performed. Nurses, who were instructed how to perform the data collection using standardized forms, performed data collection. Demographic, functional and health variables were documented and analyzed. RESULTS: More than half of all participating clients (n = 923; median age 83 years (range 21-104)) were affected by dry skin (51.7 (95% CI 48.5 to 54.9). The most often affected skin areas were the distal extremities. Males and immobile clients were more often affected than females and mobile clients. In the adjusted analysis pruritus and the presence of incontinence-associated dermatitis were most strongly associated with dry skin. CONCLUSION: Dry skin occurs widely in home care and is strongly associated with pruritus. Fundamental skin care is an easy but powerful nursing intervention to treat this condition successfully. Preventive skin care strategies need to be implemented in the home care setting to improve skin health and integrity either by nurses and/or informal caregivers.

Transepidermal water loss in healthy adults: a systematic review and meta-analysis update.

BACKGROUND: Transepidermal water loss (TEWL) is one of the most important skin barrier characteristics. Higher TEWL is usually associated with skin barrier impairments, and lower TEWL with healthy skin. OBJECTIVES: To update an existing systematic review and meta-analysis to provide TEWL reference values for healthy skin in adults. METHODS: The databases MEDLINE and Embase and other sources were searched. This update includes studies identified by two combined searches that cover the period from 1947 to 13 April 2017. Primary empirical observational and interventional studies in healthy adults providing quantitative estimates of TEWL measurements including measures of spread, such as SDs, with clear reporting of skin areas and age were included. Data were extracted per skin area and statistically pooled. RESULTS: After full-text assessment, the results of 45 studies were included additionally to the existing meta-analysis. TEWL estimates were identified for 86 skin areas in 212 studies. The lowest TEWL of 2·3 g m-2 h-1 (95% confidence interval 1·9-2·7) was reported for breast skin and the highest TEWL of 44·0 g m-2 h-1 (95% confidence interval 39·8-48·2) for the axilla. Sample sizes ranged from four (forehead middle left middle) to 4013 (mid volar right forearm). The clinical relevance of the difference between TEWL estimates for different measurement devices seems to be minimal. TEWL in elderly patients was either similar to or lower than values in the younger group. CONCLUSIONS: Reference estimates are useful for clinical study planning and interpretation of results. TEWL is highly dependent on skin area, and our results further support the symmetry between right and left measuring sites. TEWL in elderly people seems to be generally similar or decreased compared with younger individuals, but available evidence is limited. Reporting of TEWL should be improved: mean and spread parameters should always be reported in future studies.

[Recognition and correct classification of pressure ulcers: a position paper]. / Dekubitus erkennen und richtig klassifizieren: ein Positionspapier.

BACKGROUND: Pressure ulcers comprise serious skin and tissue damage. The correct diagnosis and classification into different categories is often difficult in daily practice. QUESTION: What procedure can be recommended to correctly diagnose and classify pressure ulcers in practice? MATERIALS AND METHODS: The society Initiative Chronische Wunden (ICW) e. V. established a group of experts who developed practical recommendations for the diagnosis and classification of pressure ulcers based on the current literature and their own expertise. RESULTS: Pressure ulcers should only be diagnosed if skin and/or tissue damage is most likely due to prolonged pressure or pressure associated with shear forces. A complete anamnesis must be performed to detect periods of previous prolonged immobility. Pressure ulcers are usually located at typical predilection sites. For category I and "suspected deep tissue damage" the tissue damage occurs under (initially) intact skin. However, the diagnosis is uncertain and the classification should be made later. The category II pressure ulcer is usually an exclusion diagnosis. The categories III and IV are pressure ulcers in the proper sense. As long as the distinction between category III and IV is not possible, the lower category should be coded. CONCLUSIONS: Currently, a relevant classification should be used uniformly for the respective setting. In accordance with the clinical picture, a most suitable diagnosis is to be made. It does not matter which classification system is used. The future WHO ICD-11 version will allow better classification of pressure ulcers.