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The concept of psoriatic arthritis (PsA) prevention is gaining increased interest owing to the physical limitation, poor quality of life and low remission rates that are achieved with current therapies for PsA. The psoriasis-to-PsA transition offers a unique opportunity to identify individuals at increased risk of developing PsA and to implement preventive strategies. However, identifying individuals at increased risk of developing PsA is challenging as there is no consensus on how this population should be defined. This Consensus Statement puts forward recommended terminology from the Psoriasis and Psoriatic Arthritis Clinics Multicenter Advancement Network (PPACMAN) for defining specific subgroups of individuals during the preclinical and early clinical phases of PsA to be used in research studies. Following a three-round Delphi process, consensus was reached for three terms and definitions: ‘increased risk for PsA’, ‘psoriasis with asymptomatic synovio-entheseal imaging abnormalities’ and ‘psoriasis with musculoskeletal symptoms not explained by other diagnosis’. These terms and their definitions will enable improved identification and standardization of study populations in clinical research. In the future, as increasing evidence emerges regarding the molecular and clinical features of the psoriasis-to-PsA continuum, these terms and definitions will be further refined and updated.In this Consensus Statement, an expert panel from the Psoriasis and Psoriatic Arthritis Clinics Multicenter Advancement Network (PPACMAN) recommends terminology for defining specific subgroups of individuals during the preclinical and early clinical phases of psoriatic arthritis to be used in research studies.

ObjectiveThe lack of standardised outcomes and outcome measures for cutaneous lupus erythematosus (CLE) represents a substantial barrier to clinical trial design, comparative analysis and approval of novel investigative treatments. We aimed to develop a working core outcome set (COS) for CLE randomised controlled trials and longitudinal observational studies.MethodsWe conducted a multistage literature review of CLE and SLE studies to generate candidate domains and outcome measures. Domains were narrowed to a working core domain set. Outcome measures for core domains were identified and examined.ResultsProposed core domains include skin-specific disease activity and damage, investigator global assessment (IGA) of disease activity, symptoms (encompassing itch, pain and photosensitivity), health-related quality of life (HRQoL) and patient global assessment (PtGA) of disease activity. Recommended physician-reported outcome measures include the Cutaneous Lupus Erythematous Disease Area and Severity Index (CLASI) and Cutaneous Lupus Activity IGA (CLA-IGA). For the domains of symptoms, HRQoL and PtGA of disease activity, we were unable to recommend one clearly superior instrument.ConclusionThis work represents a starting point for further refinement pending formal consensus activities and more rigorous evaluations of outcome measure quality. In the interim, the proposed working COS can serve as a much-needed guide for upcoming CLE clinical trials.

Vaccination rates among adults in the United States, including dermatology patients, remain suboptimal. Previous research has concluded that outpatient specialty offices often have administrative and patient-related barriers to administering vaccines in their clinics, however, this has never been examined specifically in dermatology. This study aims to examine dermatologists’ perspectives on vaccine education in dermatology clinics, identify facilitators and barriers to vaccine administration in dermatology clinics, and explore strategies to improve vaccination rates in dermatology patients. Virtual, semi-structured interviews were conducted with board-certified dermatologists to explore their perspectives on vaccines in dermatology clinic. The Consolidated Framework for Implementation Research was used to analyze the data. Participating dermatologists were 60% female ( n  = 9) and 40% male ( n  = 6) and had a median of 7 years of clinic experience (min–max: 3–39 years). Vaccine education emerged as one of the prominent themes during the interview with dermatologists, who emphasized the importance of comprehensive vaccine education for both healthcare providers and patients. Barriers identified encompassed patient hesitancy, lack of provider knowledge, resource limitations, and logistical challenges. Dermatologists proposed solutions such as standardized protocols, improved patient communication, enhanced coordination with other healthcare providers, and increased clinic resources. These results emphasize that dermatologists can play a crucial role in advocating for and addressing preventative care through vaccine implementation and provide a high-level framework to think about implementation. Additionally, this study highlights the need for comprehensive vaccine education, systematic implementation strategies, and organizational support within dermatology clinics to improve vaccine administration for patients.

Having a chronic disease is one of the most consistent factors associated with vaccine uptake for adults in the general population, but vaccination beliefs and behaviors specific to those with chronic skin diseases have not been explored. The objective of this study was to explore factors associated with vaccine uptake and barriers to vaccination in adults with psoriasis and eczema. Virtual, video-based semi-structured interviews were performed with adults who self-reported a diagnosis of psoriasis or eczema. Interviews explored themes around healthcare decision making, perceived risks/benefits to vaccination, barriers, and vaccine knowledge. Thematic analysis was used to analyze the data. Of 34 study participants, 25 participants (74%) were females and 9 (26%) were males, with a mean age of 50.8 years (SD: 16.4, range: 24–71 yrs). Half of participants ( n = 17) had psoriasis, and half ( n = 17) had eczema. Participants recognized both personal and societal benefits to vaccines. Common vaccination barriers identified were access to appointments, concerns about side effects, and misinformation. Physicians, friends/family, and media, including internet resources, were health information resources identified by patients. These results summarize the unique patient perspective around vaccine uptake in adults with eczema and psoriasis and represent an important first step in a multi-pronged approach to improve vaccination rates in adults with chronic skin diseases.

Patients with autoimmune bullous diseases are at an increased risk of infection, both from the underlying skin disease and from immunosuppressive treatments. Limited information is available on vaccine beliefs and behaviors in dermatology patients and adults with autoimmune bullous diseases in particular. To understand vaccine decision making, identify perceived risks and benefits of vaccinations, and discuss individual experiences in patients with autoimmune bullous diseases in the United States. A qualitative study was performed utilizing semi-structured interviews, and analysis was conducted on NVivo. Patterns were identified in the coded data, and representative quotations were recorded for each major theme. Interviews were conducted between February 15, 2022 and September 15, 2022. Twenty patients with a diagnosis of bullous pemphigoid, mucous membrane pemphigoid, pemphigus vulgaris, or pemphigus foliaceous were interviewed. Of the 20 participants, 14 (70%) were female, with a mean (SD, range) age of 64.8 (13.2, 34–83) years. Key themes that emerged from qualitative analysis of the interviews included patient concerns regarding their increased susceptibility to infection, potential exacerbation of skin disease following vaccination, and the effect of immunosuppressive medications on humoral response to vaccines. Lack of appointment availability, difficulty accessing vaccines, and cost were commonly identified barriers to vaccination. These findings provide valuable knowledge for dermatologists in regard to providing counseling specific to patient concerns and to improve communication surrounding vaccination in the dermatology setting.

Background and Objective The International Dermatology Outcome Measures (IDEOM) has defined a core set of domains to be measured in all psoriasis clinical trials. This set comprises the following domains: skin manifestations, psoriasis and psoriatic arthritis symptoms, health-related quality of life, investigator global, patient global, and treatment satisfaction. The next step is to define how to measure these domains. The objective of this article was to evaluate the quality of available instruments to assess ‘investigator global’ and ‘patient global’ domains to identify the most appropriate instruments. Methods Reviewers conducted a systematic literature review to retrieve studies on the measurement properties of instruments including either an investigator global assessment or a patient global assessment. Following the COnsensus based standards for the Selection of health Measurement INstruments (COSMIN) checklist, three independent reviewers rated the quality of each study. We then performed a qualitative synthesis of the evidence. Results We identified nine investigator global assessments and three patient global assessments, reflecting substantial variability in global assessment instruments. Overall, most measures lacked evidence for content validity and feasibility. The Lattice System-Physician Global Assessment, Product of the Investigator Global Assessment and Body Surface Area, and the professional-Simplified Psoriasis Index had higher levels of evidence for validity, reliability, and/or responsiveness than the 5- and 6-point investigator global assessments. The self-assessment-Simplified Psoriasis Index was the only patient global assessment with evidence for validity, reliability, and responsiveness. Conclusions The 5- and 6-point investigator global assessments, which are the most widely used investigator global assessments in registered clinical trials, have less evidence for measurement properties as compared with the Lattice System-Physician Global Assessment, professional-Simplified Psoriasis Index, and the Product of the Investigator Global Assessment and Body Surface Area. However, all instruments lack evidence for content validity and feasibility. Further validation studies of investigator global assessments and patient global assessments are required to recommend the best global measure for psoriasis clinical trials.

Psoriasis is a chronic, immune-mediated, inflammatory skin disease that affects approximately 125 million people globally. Over the last two decades, extensive research has shown that psoriasis is associated with multiple extra-cutaneous co-morbidities including psoriatic arthritis (PsA) and sleep disturbance. Despite the relationship between psoriasis and these co-morbidities having been established, both PsA and sleep disturbance remain largely under-explored, under-diagnosed and, therefore, under-treated in this population. Patient-reported outcome measures (PROMs) are questionnaires designed to collect data derived directly from patients to measure an explicit concept such as quality of life, functioning, symptoms or health status without interpretation by healthcare providers. Currently, there are thousands of PROMs available across disease states and their use is becoming vital in clinical settings to improve health-care delivery as well as in clinical trials to support label claims.However, not all PROMs are equally useful. Selecting the most appropriate measures is critical asa PROM is only as valuable as its ability to accurately and precisely measure what it intends to measure, which starts with the earliest conceptual design elements. A given instrument should be based on a theoretical conceptual framework of what it intends to measure, should include patients in its development process to ensure its relevance to the target population and context of use, and have adequate psychometric properties. The overarching aim of this thesis is to optimize the assessment of highly prevalent but under-recognized comorbidities in psoriatic disease by using standardized PROMs. The aim of first project of this thesis is to select the best PROM to assess PsA symptoms in psoriasis clinical trials. The aim of the second project, is to develop a robust sleep questionnaire to assess sleep disturbance across psoriasis and psoriatic arthritis.

IntroductionCutaneous T cell lymphoma (CTCL) is a group of non-Hodgkin lymphomas that primarily affects the skin and can mimic inflammatory dermatoses. Unlike many skin diseases, CTCL can lead to disabling symptoms, and advanced CTCL can even be fatal. Early studies investigating health-related quality of life (HRQOL) in patients with mycosis fungoides (MF) and Sézary syndrome (SS), common subtypes of CTCL, demonstrated significant impairment across numerous domains. The aim of this current study is to develop a core domain set (CDS) to identify the essential aspects of MF/SS that influence HRQOL that should be measured in therapeutic clinical trials. In the future, this set of core concepts will be used to identify the best patient- reported outcome measure(s) (PROM) for HRQOL for MF/SS clinical research.Methods and analysisMultiple strategies will be used to generate candidate concepts: systematic review of the literature, qualitative study and a survey study of healthcare providers. A Delphi consensus process including a comprehensive group of stakeholders (patients, caregivers/care partners, a multidisciplinary group of healthcare professionals, patient advocacy groups, pharmaceutical industry representatives, methodologists and government agencies) will be used to achieve consensus. Statistical corrections for multiple significance testing and false positive findings will be undertaken.Ethics and disseminationThe study was submitted for and received institutional review board approval at the University of Washington (IRB# STUDY00018890 and STUDY00019407). Informed consent will be obtained from all participants where necessary. We will disseminate our findings through peer-reviewed, open access publications and presentations at national/international conferences. We will provide a plain language summary in lay terms for patients and families to patient advocacy groups for distribution to their network.Registration detailsThe protocol is registered in the Core Outcome Measures in Effectiveness Trials (COMET) database.

Psoriatic arthritis (PsA) is rarely assessed in psoriasis randomized controlled trials (RCT); thus, the effect of psoriasis therapy on PsA is unknown. The International Dermatology Outcome Measures (IDEOM) has included “PsA Symptoms” as part of the core domains to be measured in psoriasis RCT. This study aimed to achieve consensus about screening for PsA and how to measure for “PsA Symptoms” in psoriasis RCT. At the IDEOM 2017 Annual Meeting, stakeholders voted on the role of PsA screening in psoriasis RCT. To select measures for “PsA Symptoms”, we adapted the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines. Three potential measures were selected. At the meeting, stakeholders voted on the validity, feasibility, and responsiveness of these measures. Of the 47 stakeholders, 93% voted that all psoriasis trial participants should be screened for PsA. “PsA Symptoms” measures included Patient Global (PG)-arthritis, Routine Assessment Patient Index Data (RAPID)-3, and Psoriatic Arthritis Impact of Disease (PsAID)-9. During the voting, more than 50% of the voters agreed that RAPID3 and PsAID9 were good measures for PsA Symptoms, able to capture all its essential elements. PsAID9 was considered the most feasible instrument, followed by RAPID3 and PG-arthritis, respectively. Finally, most participants agreed that RAPID3 and PsAID9 were responsive measures. Most study participants voted that all subjects in a psoriasis clinical trial should be screened for PsA. RAPID3 and PsAID9 outperformed PG-arthritis in measuring PsA Symptoms. This will be followed by a Delphi survey involving a larger stakeholder group.