Skin health of community-living older people: a scoping review.

The population of older people is steadily increasing and the majority live at home. Although the home and community are the largest care settings worldwide, most of the evidence on dermatological care relates to secondary and tertiary care. The overall aims were to map the available evidence regarding the epidemiology and burden of the most frequent skin conditions and regarding effects of screening, risk assessment, diagnosis, prevention and treatment of the most frequent skin conditions in older people living in the community. A scoping review was conducted. MEDLINE, Embase and Epistemonikos were systematically searched for clinical practice guidelines, reviews and primary studies, as well as Grey Matters and EASY for grey literature published between January 2010 and March 2023. Records were screened and data of included studies extracted by two reviewers, independently. Results were summarised descriptively. In total, 97 publications were included. The vast majority described prevalence or incidence estimates. Ranges of age groups varied widely and unclear reporting was frequent. Sun-exposure and age-related skin conditions such as actinic keratoses, xerosis cutis, neoplasms and inflammatory diseases were the most frequent dermatoses identified, although melanoma and/or non-melanoma skin cancer were the skin conditions investigated most frequently. Evidence regarding the burden of skin conditions included self-reported skin symptoms and concerns, mortality, burden on the health system, and impact on quality of life. A minority of articles reported effects of screening, risk assessment, diagnosis, prevention and treatment, mainly regarding skin cancer. A high number of skin conditions and diseases affect older people living at home and in the community but evidence about the burden and effective prevention and treatment strategies is weak. Best practices of how to improve dermatological care in older people remain to be determined and there is a particular need for interventional studies to support and to improve skin health at home.

Methods for Neuroscience Drug Development: Guidance on Standardization of the Process for Defining Clinical Outcome Strategies in Clinical Trials.

Neurosciences clinical trials continue to have notoriously high failure rates. Appropriate outcomes selection in early clinical trials is key to maximizing the likelihood of identifying new treatments in psychiatry and neurology. The field lacks good standards for designing outcome strategies, therefore The Outcomes Research Group was formed to develop and promote good practices in outcome selection. This article describes the first published guidance on the standardization of the process for clinical outcomes in neuroscience. A minimal step process is defined starting as early as possible, covering key activities for evidence generation in support of content validity, patient-centricity, validity requirements and considerations for regulatory acceptance. Feedback from expert members is provided, regarding the risks of shortening the process and examples supporting the recommended process are summarized. This methodology is now available to researchers in industry, academia or clinics aiming to implement consensus-based standard practices for clinical outcome selection, contributing to maximizing the efficiency of clinical research.

Technology for managing incontinence: What are the research priorities?

Incontinence and toileting difficulties can often be successfully addressed by treating their underlying causes. However, (complete) cure is not always possible and continence products to prevent or contain unresolved leakage or to facilitate toileting are in widespread use. Many people use them successfully but identifying the product(s) most likely to meet individual needs can be challenging and the recently published Seventh International Consultation on Incontinence includes a chapter which draws on the literature to provide evidence-based recommendations to help clinicians and product users to select appropriate products. This paper is based on the same evidence, but reviewed from the different perspective of those keen to identify unmet needs and develop improved products. For each of the main continence product categories it (i) outlines the design approach and key features of what is currently available; (ii) provides a generic functional design specification; (iii) reviews how well existing products meet the requirements of their main user groups; and (iv) suggests priorities for the attention of product designers. It also flags some core scientific problems which - if successfully addressed - would likely yield benefits in multiple incontinence product contexts.

Effects of a leave-on product on the strength of the dermoepidermal junction: An exploratory, intraindividual, randomized controlled trial in older adults with dry skin.

Background and Aims: Skin aging is associated with dry skin and a decrease of the strength of the dermoepidermal adhesion, which increases the risk for lacerations (skin tears). Application of leave-on products improves dry skin and seems to reduce skin tear incidence. The aim of this study was to measure the effects of a humectant containing leave-on product on the strength of the dermoepidermal junction in older adult participants with dry skin. Methods: A randomized controlled trial using a split body design was conducted. One forearm was randomly selected and treated with a lipophilic leave-on product containing 5% urea for 8 weeks. The other forearm was the control. The parameters stratum corneum hydration (SCH), transepidermal water loss, pH, roughness, epidermal thickness and skin stiffness were measured at the baseline, Weeks 4 and 8. At Week 8, suction blisters were created and time to blistering was measured. Blister roofs and interstitial fluid were analyzed for Interleukin-1α, 6 and 8. Results: Twelve participants were included. After 8 weeks treatment, SCH was higher (median difference 11.6 AU), and the overall dry skin score (median difference -1) and median roughness (Rz difference -12.2 µm) were lower compared to the control arms. The median group difference for Interleukin-1α was -452 fg/µg total protein (TP) in the blister roofs and -2.2 fg/µg TP in the blister fluids. The median time to blister formation was 7.7 min higher compared to the control arms. Conclusion: The regular application of humectant containing leave-on products improves dry skin and seems to lower inflammation and contribute to the strengthening of the dermoepidermal adhesion. This partly explains how the use of topical leave-on products helps to prevent skin tears.

Using behavioral science to increase core outcome set use in trials.

OBJECTIVES: Core outcome sets (COS) are agreed sets of outcomes for use in clinical trials, which can increase standardization and reduce heterogeneity of outcomes in research. Using a COS, or not, is a behavior that can potentially be increased using behavioral strategies. The aim of this study was to identify behavioral intervention components to potentially increase use of COS in trials. METHODS: This project was informed by the Behavior Change Wheel framework. Two reviewers extracted barriers and facilitators to COS use from four recently published studies examining COS use in trials. Barriers and facilitators were coded to the Capability, Opportunity, Motivation-Behavior (COM-B) model, which forms part of the Behavior Change Wheel. COM-B findings were mapped to intervention functions by two reviewers, and then mapped to behavior change techniques (BCTs). Full-team Affordability, Practicability, Effectiveness/Cost-effectiveness, Acceptability, Side effects/Safety, Equity ratings were used to reach consensus on intervention functions and BCTs. BCTs were operationalized using examples of tangible potential applications and were categorized based on similarity. RESULTS: Barriers and facilitators were identified for all capability, opportunity and motivation aspects of the COM-B model. Five intervention functions (education, training, enablement, persuasion, and modeling) and 15 BCTs were identified. Thirty-six BCT examples were developed, including providing information on benefits of COS for health research, and information choosing COS. BCT examples are categorized by approaches related to "workshops," "guidance," "audio/visual resources," and "other resources." CONCLUSION: Study findings represent diverse ways to potentially increase COS use in trials. Future work is needed to examine effects of these behavioral intervention components on COS use. If effective, increased use of COS can improve outcome reporting and minimize outcome heterogeneity and research waste.

Protocol of a scoping review of outcome domains in dermatology.

INTRODUCTION: Core outcome sets (COSs) are agreed outcomes (domains (subdomains) and instruments) that should be measured as a minimum in clinical trials or practice in certain diseases or clinical fields. Worldwide, the number of COSs is increasing and there might be conceptual overlaps of domains (subdomains) and instruments within disciplines. The aim of this scoping review is to map and to classify all outcomes identified with COS projects relating to skin diseases. METHODS AND ANALYSIS: We will conduct a scoping review of outcomes of skin disease-related COS initiatives to identify all concepts and their definitions. We will search PubMed, Embase and Cochrane library. The search dates will be 1 January 2010 (the point at which Core Outcome Measures in Effectiveness Trials (COMET) was established) to 1 January 2024. We will also review the COMET database and C3 website to identify parts of COSs (domains and/or instruments) that are being developed and published. This review will be supplemented by querying relevant stakeholders from COS organisations, dermatology organisations and patient organisations for additional COSs that were developed. The resulting long lists of outcomes will then be mapped into conceptually similar concepts. ETHICS AND DISSEMINATION: This study was supported by departmental research funds from the Department of Dermatology at Northwestern University. An ethics committee review was waived since this protocol was done by staff researchers with no involvement of patient care. Conflicts of interests, if any, will be addressed by replacing participants with relevant conflicts or reassigning them. The results will be disseminated through publication in peer-reviewed journals, social media posts and promotion by COS organisations.

Skin care types, frequencies and products: A cross-sectional study in German institutional long-term care.

AIM: The aim of the study was to describe types and frequencies of skin care interventions and products provided in institutional long-term care. MATERIALS AND METHODS: Baseline data from a cluster randomized controlled trial conducted in nursing homes in Berlin, Germany was collected before randomization. Numbers, proportions and frequencies of washing, showering and bathing, and the application of leave-on products were calculated. Product labels were iteratively and inductively categorized into overarching terms and concepts. RESULTS: A total of n = 314 residents participated in the study. In the majority, washing of the whole body was done once daily, and showering was performed once per week or more rarely. The majority received leave-on products daily on the face and once per week on the whole body. Most of the skin care interventions were delivered by nurses. There was marked heterogeneity in terms of product names, whereas the product names reveal little about the ingredients or composition. CONCLUSION: Personal hygiene and cleansing interventions are major parts of clinical practice in long-term care. Daily washing is a standard practice at the moment. In contrast, leave-on products are used infrequently. To what extent the provided care promotes skin integrity is unclear. Due to the heterogeneity and partly misleading labels of skin care products, informed decision making is difficult to implement at present. GOV IDENTIFIER: NCT03824886.

Prognostic models for clinical outcomes in patients with venous leg ulcers: A systematic review.

OBJECTIVE: The purpose of this review was to identify prognostic models for clinical application in patients with venous leg ulcers (VLUs). METHODS: Literature searches were conducted in Embase, Medline, Cochrane, and CINAHL databases from inception to December 22, 2021. Eligible studies reported prognostic models aimed at developing, validating, and adjusting multivariable prognostic models that include multiple prognostic factors combined, and that predicted clinical outcomes. Methodological quality was assessed using the CHARMS checklist and PROBAST short form questionnaire. RESULTS: Thirteen studies were identified, of which three were validation studies of previously published models, four reported derivation and validation of models, and the remainder reported derivation models only. There was substantial heterogeneity in the model characteristics, including 11 studies focused on wound healing outcomes reporting 91 different predictors. Three studies shared similar predicted outcomes, follow-up timepoint and used a Cox proportional hazards model. However, these models reported different predictor selection methods and different predictors and it was therefore not feasible to summarize performance, such as discriminative ability. CONCLUSIONS: There are no standout risk prediction models in the literature with promising clinical application for patients with VLUs. Future research should focus on developing and validating high-performing models in wider VLU populations.

Protocol for the Development of the Fourth Edition of the Prevention and Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline Using GRADE Methods.

ABSTRACT: The National Pressure Injury Advisory Panel, European Pressure Ulcer Advisory Panel, and the Pan Pacific Pressure Injury Alliance are commencing a new (fourth) edition of the Prevention and Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline . The fourth edition of the International Pressure Injury (PI) Guideline will be developed using GRADE methods to ensure a rigorous process consistent with evolving international standards. Clinical questions will address prevention and treatment of PIs, identification of individuals at risk of PIs, assessment of skin and tissues, and PI assessment. Implementation considerations supporting application of the guidance in clinical practice will be developed. The guideline development process will be overseen by a guideline governance group and methodologist; the guideline development team will include health professionals, educators, researchers, individuals with or at risk of PIs, and informal carers.This article presents the project structure and processes to be used to undertake a systematic literature search, appraise risk of bias of the evidence, and aggregate research findings. The methods detail how certainty of evidence will be evaluated; presentation of relative benefits, risks, feasibility, acceptability, and resource requirements; and how recommendations will be made and graded. The methods outline transparent processes of development that combine scientific research with best clinical practice. Strong involvement from health professionals, educators, individuals with PIs, and informal carers will enhance the guideline's relevance and facilitate uptake. This update builds on previous editions to ensure consistency and comparability, with methodology changes improving the guideline's quality and clarity.

The prevalence and severity of dry skin and related skin care in older adult residents in institutional long-term care: A cross-sectional study.

OBJECTIVES: To identify possible factors associated with different severities of xerosis cutis and to describe possible associations between (skin) care dependency and application of moisturizers. DESIGN: Cross-sectional study using baseline data from a cluster-randomized controlled trial. Demographic and health characteristics, skin physiological measurements, functional abilities and application of moisturizers were compared between the participants with mild and severe dry skin. Frequency of moisturization were also compared based on the participants' skin care dependency. RESULTS: The more distal the body area, the more severe xerosis were observed. There were no or minor differences between the groups, except for the stratum corneum hydration and skin surface pH. Participants with severe xerosis received moisturizers less often. Skin care dependent residents received moisturizers frequently. CONCLUSION: There is under-application regarding xerosis cutis treatment in long-term care. Skin care provided by nurses, in adequate frequencies, might be helpful compared to skin care performed by the residents themselves.

Non-pharmacological interventions to prevent and manage delirium in critically ill children in neonatal and paediatric intensive care units (NICU/PICU): a scoping review protocol.

INTRODUCTION: Delirium is one of the most common forms of acute cerebral dysfunction in critically ill children leading to increased morbidity and mortality. Prevention, identification and management of delirium is an important part of paediatric and neonatological intensive care. This scoping review aims to identify and map evidence on non-pharmacological interventions for paediatric delirium prevention and management in paediatric and neonatal intensive care settings. METHODS AND ANALYSIS: This scoping review will be conducted according to the Joanna Briggs Institute methodology for scoping reviews and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. Searches will be performed in the databases Medline (via PubMed), CINAHL, Cochrane Library, Ovid (Journals), EMBASE and Web of Science (01/2000-current). Two reviewers will independently review retrieved studies, and relevant information will be extracted using data extraction forms. The results will be presented in tabular format and accompanied by a narrative summary. INCLUSION CRITERIA: The review will include references that describe or evaluate non-pharmacological interventions to prevent or manage paediatric delirium. Conference abstracts, editorials, opinion papers and grey literature will be excluded. ETHICS AND DISSEMINATION: Due to the nature of research involving humans or unpublished secondary data, approval of an ethics committee are not required. The dissemination of findings is planned via professional networks and publication in an open-access scientific journal.

The theory and practice of pressure ulcer/injury risk assessment: a critical discussion.

Pressure ulcer/injury (PU) risk assessment is widely considered an essential component in clinical practice. It is a complex and broad concept that includes different approaches, such as clinical judgement, using standardised risk assessment instruments, skin assessments, or using devices to measure skin or tissue properties. A distinction between PU risk assessment and early detection is important. PU risk measures the individual's susceptibility to developing a PU under a specific exposure (primary prevention), and early detection includes the assessment of early (sub)clinical signs and symptoms to prevent progression and to support healing (secondary prevention). PU risk is measured using prognostic/risk factors or prognostic models. Every risk estimate is a probability statement containing varying degrees of uncertainty. It therefore follows that every clinical decision based on risk estimates also contains uncertainty. PU risk assessment and prevention is a complex intervention, where delivery contains several interacting components. There is a huge body of evidence indicating that risk assessment and its outcomes, the selection of preventive interventions and PU incidence are not well connected. Methods for prognostic model development and testing in PU risk research must be improved and follow state-of-the-art methodological standards. Despite these challenges, we do have substantial knowledge about PU risk factors that helps us to make better clinical decisions. An important next step in the development of PU risk prediction might be the combination of clinical and other predictors for more individualised care. Any prognostic test or procedure must lead to better prevention at an acceptable cost.