Value in psoriasis (IRIS) trial: implementing value-based healthcare in psoriasis management - a 1-year prospective clinical study to evaluate feasibility and value creation.

INTRODUCTION: Currently, the healthcare sector is under tremendous financial pressure, and many acknowledge that a dramatic shift is required as the current system is not sustainable. Furthermore, the quality of care that is delivered varies strongly. Several solutions have been proposed of which the conceptual framework known as value-based healthcare (VBHC) is further explored in this study for psoriasis. Psoriasis is a chronic inflammatory skin disease, which is associated with a high disease burden and high treatment costs. The objective of this study is to investigate the feasibility of using the VBHC framework for the management of psoriasis. METHODS AND ANALYSIS: This is a prospective clinical study in which new patients attending the psoriasis clinic (PsoPlus) of the Ghent University Hospital will be followed up during a period of 1 year. The main outcome is to determine the value created for psoriasis patients. The created value will be considered as a reflection of the evolution of the value score (ie, the weighted outputs (outcomes) divided by weighted inputs (costs)) obtained using data envelopment analysis. Secondary outcomes are related to comorbidity control, outcome evolution and treatment costs. In addition, a bundled payment scheme will be determined as well as potential improvements in the treatment process. A total of 350 patients will be included in this trial and the study initiation is foreseen on 1 March 2023. ETHICS AND DISSEMINATION: This study has been approved by the Ethics Committee of the Ghent University Hospital. The findings of this study will be disseminated by various means: (1) publication in one or more peer-reviewed dermatology and/or management journals, (2) (inter)national congresses, (3) via the psoriasis patient community and (4) through the research team's social media channels. TRIAL REGISTRATION NUMBER: NCT05480917.

PsoPlus: An Integrated Practice Unit for Psoriasis.

There is a need to revise the current healthcare organization due to the ever-rising costs and variation in quality of delivered care. Over the past decades there have been several strategic frameworks attempting to tackle this problem. Value-based healthcare (VBHC) is one of those frameworks which has gained increasing popularity the last years. The framework is formulated on the premise that the healthcare sector should deliver integrated care, using integrated practice units (IPUs), and strive to maximize the value created. Value in this context is defined as the health outcomes achieved per costs made. We have designed a lean IPU called PsoPlus in which psoriasis patients are managed by a multidisciplinary team which has all the expertise and skill to manage psoriasis and its associated conditions. In addition, we have developed and implemented guidelines for the management of psoriasis-associated comorbidities, enabling us to deliver integrated care in the Belgian healthcare setting. Finally, we have designed a supporting information technology platform, called PsoSmart, which brings data from patients and healthcare providers together and provides actionable insights for clinical decision making. The created value is documented and captured using a value-based outcome set. Cost assessments at the individual patient level are also performed. To conclude, we describe here a comprehensive IPU setting for psoriasis which incorporates the VBHC principles. This IPU goes further and delivers a higher level of integrated care than other multidisciplinary psoriasis clinics. Monitoring outcomes and costs provides us with further insights to optimize psoriasis care. In addition, a software program designed to enhance psoriasis care is being developed further; however, advances in healthcare technology are needed.

Angiosarcoma Mimicking Rhinophyma.

This case report describes a man in his 60s who was referred to the department of dermatology for further evaluation of a lesion on the nose.

Initiating value-based healthcare in psoriasis: Proposing a value-based outcome set for daily clinical practice.

BACKGROUND: With the current trend in healthcare moving towards a more value-based approach, it is essential to understand what value encompasses. OBJECTIVES: To develop an actionable value-based outcome set (VOS) for daily practice. METHODS: A mixed method approach was used consisting of four phases. Formerly, a systematic review was conducted, providing an overview of all patient-relevant outcomes defined in current literature. These 23 outcomes were then presented to a group of patients, using a modified nominal group technique (NGT), to establish whether these results represented all of their relevant outcomes. Subsequently, these outcomes were ranked according to importance by patients attending our academic specialized psoriasis clinic. A review of the literature was performed to assess which instruments were available and suitable to evaluate the outcomes in this VOS. Finally, a pilot feasibility test was performed amongst patients. RESULTS: Of the 23 outcomes, two were omitted from the ranking exercise after the NGT. In the ranking exercise, 120 patients participated. The median age was 50.0 (IQR 25.0) years and 36.7% were female. Median PASI score was 2.4 (IQR 5.2), and treatments varied from topicals to biologicals. The outcomes scored as most important were symptom control, treatment efficacy, confidence in care and control of disease. The least important outcomes were comorbidity control, productivity and cost of care. A significant difference was shown between the ranking of the outcomes (p < 0.001). In total, 12 instruments were selected, which are reported by both patient and provider, to measure the outcomes in this VOS. Median completion time for the patient part was 30 min (IQR 2.8). CONCLUSIONS: This VOS is a first proposal to evaluate psoriasis care in a value-based manner. Measuring these outcomes can enable us to critically appraise and improve current care processes, within the reality of available resources, thereby increasing value for patients.

Image analysis systems to calculate the surface area of vitiligo lesions: A systematic review of measurement properties.

Several digital image analysis systems have been developed for surface calculation of vitiligo lesions. Critical assessment of their measurement properties is crucial to support evidence-based recommendations on the most suitable instruments and will reveal the need for future research. A systematic review was performed to systematically summarize, compare, and critically assess the measurement properties of digital and analogue analysis systems for surface calculation of vitiligo lesions following the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) recommendations. Nineteen clinical trials were selected including 25 different instruments. Manual tracing on transparent sheets (contact planimetry) combined with digital measurement or point counting can be considered as the best validated method for the evaluation of target lesions taking into account the skin curvatures. Two-dimensional digital imaging analysis on photographs seems also robust although confirmatory data of different research groups using the same digital instrument in a wide range of skin types are missing. Analysis based on 3D photography is still in its early stage but is promising for whole-body analysis. However, the reported data on the quality of the instruments for surface area calculation of vitiligo lesions were in general rather limited. Therefore, future high-quality validation studies are required also including full body evaluations.

Patient-Relevant Outcomes in Psoriasis: A Systematic Review.

Importance: There is a need to define which outcomes matter to patients with psoriasis to deliver value for the patient when managing their condition. Objectives: To generate a comprehensive overview of all outcomes relevant in the management of psoriasis as defined by patients. Evidence Review: A systematic review was performed by searching 3 databases (MEDLINE, Embase, and Web of Science) from August 1, 2019, until March 27, 2021, using a comprehensive search strategy consisting of 4 concepts including psoriasis, patients, outcomes, and relevance. A (citing) reference search was also performed of all retrieved articles. Two independent reviewers screened the retrieved records by title/abstract against the eligibility criteria. Studies were eligible for inclusion if they reported on the importance of outcomes for patients with psoriasis. No language restrictions were used. Data extraction and quality assessment were also performed independently. Quality assessment was done using the QUALSYST tool. Findings: In total, 10 365 records were screened for eligibility, of which 24 studies were included for synthesis. A total of 23 317 patients were evaluated, and 273 (154 unique) items were retrieved. These items were aggregated into 23 outcomes: (almost) complete clearance; symptom control; difficult location clearance; time to clearance; treatment efficacy, sustainability, safety, tolerability, and convenience; comorbidity control; daily and social activity; emotional well-being; intimate relationships; productivity; health-related quality of life; confidence in care; control of disease; communication with care professional; information from other sources than care professional; and cost of care (societal and for the patient). These were then further grouped into 4 core areas: physical/clinical, life impact, resource use, and adverse effects. The mean overall quality of the studies was 75.6% (range, 35.7%-100%). Conclusions and Relevance: This systematic review analyzed patient-relevant outcomes reported in patients with psoriasis to aid in the transition to a value-based treatment approach.

The Effects of Modified Intermittent Fasting in Psoriasis (MANGO): Protocol for a Two-Arm Pilot Randomized Controlled Open Cross-over Study.

BACKGROUND: Psoriasis is a complex disease associated with multiple comorbidities, including metabolic syndrome and leaky gut syndrome. Dietary lifestyle interventions have been reported to affect the disease in terms of lesional severity. It remains unclear how diets affect these comorbidities and the general health in psoriasis patients. Modified intermittent fasting (MIF) on 2 nonconsecutive days has shown beneficial effects on metabolic parameters. A significant advantage of MIF over the currently investigated dietary changes is its feasibility. OBJECTIVE: Here, we aim to study the effects of MIF on skin, gut, and metabolic health in psoriasis patients. METHODS: A 2-arm pilot randomized controlled open cross-over study will be performed in 24 patients with psoriasis. Patients will be randomized 1:1 to either start with 12 weeks of MIF and go on a subsequent regular diet for another 12 weeks or start with 12 weeks of regular diet and do subsequent MIF for 12 weeks. The following parameters will be assessed: demographics, disease phenotype, medical and familial history, psoriasis severity, dermatology-specific and general quality of life, nutritional and physical habits, mental and intestinal health, intestinal and cutaneous integrity, inflammatory and metabolic markers, and satisfaction. RESULTS: A total of 24 participants have been enrolled in the study. The final visit is foreseen for June 2021. CONCLUSIONS: The aim is to uncover the effects of MIF on psoriasis severity and gut health integrity through clinical and molecular investigation. More precisely, we want to map the evolution of the different markers, such as psoriasis severity, permeability, and inflammation, in response to MIF as compared to a regular diet,. Understanding how dietary lifestyles can affect epithelial lineages, such as the skin and gut, will greatly improve our understanding of the development of psoriasis and may offer a nonpharmacological venue for treatments. TRIAL REGISTRATION: ClinicalTrials.gov NCT04418791; https://clinicaltrials.gov/ct2/show/NCT04418791. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/26405.

Injection site reactions after long-term subcutaneous delivery of drisapersen: a retrospective study.

A retrospective study in which we reviewed the hospital files of a subset of 7 patients with Duchenne muscular dystrophy participating in the open-label phase I/II PRO051-02 study in Leuven. The objective of this study was to describe in detail the injection site reactions in these children treated with drisapersen (PRO-051), a 2'-O-methyl phosphorothioate RNA antisense oligonucleotide, that induces exon 51 skipping in Duchenne muscular dystrophy. Antisense oligonucleotides, restoring the reading frame by skipping of exons, have become a potential treatment of Duchenne muscular dystrophy and other monogenetic diseases. Erythema followed by hyperpigmentation, fibrosis, and calcification were seen at the injection sites in all children. Ulcerations, which were difficult to heal, occurred in 5 of 7 children. Progression still occurred after switching to intravenous administration of drisapersen or even after stopping therapy. Systemic reactions included a reversible proteinuria and α1-microglobulinuria. Moreover, hypotrichosis was a common feature.Conclusion: Subcutaneous administration of drisapersen causes severe and progressive injection site effects. What is known: • Antisense oligonucleotides offer the possibility to convert Duchenne muscular dystrophy to the less severe Becker type. This can potentially be achieved by targeting and skipping specific exons of the Duchenne muscular dystrophy gene to restore the disrupted reading frame and to induce the production of a semi functional dystrophin protein. • Drisapersen is such an antisense oligonucleotides which can be administered subcutaneously. Its use has been tested extensively in the escalating dose pilot study (PRO051-02). What is new: • This report describes the injection site reactions caused by this type of agent in detail which has never been done before. We therefore reviewed the hospital files of 7 patients with Duchenne muscular dystrophy participating in the phase I/II open-label, escalating dose pilot study (PRO051-02) with drisapersen. • Severe side effects starting with erythema, hyperpigmentation, and later fibrosis, calcification, and difficult to treat ulcerations developed in all patients, and these continued to progress even after cessation of drisapersen. We discuss some possible underlying mechanisms. The exact mechanism however is still not known.