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Summary: 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. Linked Comment: Lechner. Br J Dermatol 2021; 184:587. [ABSTRACT FROM AUTHOR]

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. Linked Commentary: A. Ragamin et al. J Eur Acad Dermatol Venereol 2021; 35: 276‐277. https://doi.org/10.1111/jdv.17103. [ABSTRACT FROM AUTHOR]

Summary: 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. Linked Comment: Nixon. Br J Dermatol 2020; 183:200–201. Plain language summary available online [ABSTRACT FROM AUTHOR]

Summary: 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. Linked Comment: Vitoriano. Br J Dermatol 2020; 183:13–14. Respond to this article [ABSTRACT FROM AUTHOR]