An effective patient-supporting intervention for topical treatment of psoriasis is also cost-effective.

BACKGROUND: A randomized controlled trial (RCT) of topical treatment combined with regular patient support provided by dermatological nurses in structured consultations of 20-min duration every fourth week improved psoriasis severity, quality of life and treatment adherence compared with topical treatment combined with standard patient support, which is seeing a dermatologist every third month. OBJECTIVES: To examine the economic impact of the patient support from a healthcare-sector perspective in the RCT. METHODS: Costs for primary care, secondary healthcare services and costs of prescription medication were compared for the intervention and nonintervention groups over 48 weeks. Health benefits were expressed in terms of quality-adjusted life-years (QALYs) measured by the EuroQoL five-dimension three-level questionnaire. Regression analyses were used to estimate incremental cost and QALYs. RESULTS: The incremental cost was estimated at £462, with an average increase of 0.08 QALYs per patients for participants receiving the intervention compared with those receiving standard care. The incremental cost-effectiveness ratio for patients was £5999/QALY. The intervention had an almost 100% probability of being cost-effective at a willingness-to-pay threshold of £30 000 per QALY. CONCLUSIONS: Addressing adherence issues is critical to improving outcomes for patients with psoriasis who use topical treatment. The personal support intervention was effective with an acceptable increase in costs.

Regular support provided by dermatological nurses improves outcomes in patients with psoriasis treated with topical drugs: a randomized controlled trial.

BACKGROUND: Patient adherence to topical antipsoriatic drugs is often poor, leading to poor efficacy. Use of long-term support delivered by dermatological nurses to patients treated with topical drugs may improve outcome. AIM: To evaluate whether regular support from dermatological nurses improves outcome and treatment adherence in patients with psoriasis receiving topical medications. METHODS: We conducted a randomized controlled trial (RCT) (clinicaltrials.gov registration NCT04220554), in which patients received once-daily topical medications (containing corticosteroids and/or calcipotriol) for as long as their psoriasis was visible. The patients were randomly allocated to standard care by the dermatologist either with (n = 51) or without (n = 52) support from dermatological nurses. The nurse support intervention consisted of a structured dermatological consultation at baseline and Week 1, followed by contact with a nurse each month (in the outpatient clinic or by telephone). The primary outcome was severity of psoriasis, which was measured by the Lattice System Physician's Global Assessment (LS-PGA) and assessed by intention-to-treat analyses using linear mixed regression models for longitudinal data. Secondary outcomes were quality of life (measured by the Dermatology Life Quality Index; DLQI) and good adherence (defined as use of ≥ 80% of recommended doses). RESULTS: In total, 92 patients (89%) completed the 48-week trial period. The intervention group improved more than the nonintervention group from baseline to Week 24 in LS-PGA (2.21 vs. 1.28, P = 0.001) and in DLQI at Week 12 (6.50 vs. 1.55, P < 0.001). Differences between the two groups in favour of the intervention were observed throughout the study period. More participants in the intervention group had good adherence compared with the nonintervention group (36% vs. 14%, P < 0.001). CONCLUSION: Regular, continued patient support from dermatological nurses increased the efficacy of psoriasis treatment, improved quality of life and enhanced long-term adherence to topical antipsoriatic drugs. However, there is still room for more improvement.

Can an app supporting psoriasis patients improve adherence to topical treatment? A single-blind randomized controlled trial.

BACKGROUND: Topical corticosteroid or corticosteroid/calcipotriol preparations are recommended first-line topical treatments of psoriasis, but a main cause for the lack of efficacy of topical treatments is considered low rates of adherence to topical drugs. Patient support by the use of applications (apps) for smartphones is suggested to improve medical adherence. METHODS/DESIGN: Design: An investigator-initiated, single-center, single-blind, parallel-group, phase-4 clinical superiority randomized controlled trial (RCT). PARTICIPANTS: 134 patients 18 to 75 years of age with mild-to-moderate psoriasis, who are capable of reading English language, own a smartphone, and are candidates for the study drug calcipotriol and betamethasone dipropionate (Cal/BD) cutaneous foam once daily prn (pro re nata). INTERVENTION: A 28-day adherence-supporting app providing compulsory daily treatment reminders that pop-up on the smartphone screen with a short alert sound. The app synchronizes through Bluetooth® to an electronic monitor (EM) attached to the medication canister. The EM contains a chip registering the amount of foam, day and time the patient use the foam dispenser. The information is displayed in a diary that shows the amount of Cal/BD cutaneous foam used and the number of applied treatment sessions. The app has an optional diary with the patient's rating of symptoms. Non-intervention: Use of Cal/BD cutaneous foam and EM without the app. All participants are prescribed Cal/BD cutaneous foam prn for the entire study period. Primary outcome obtained in week 4: rates of adherence measured by patient report, weight of medication canisters, and number of treatment sessions measured by the EM. Secondary outcomes obtained at baseline, weeks 4, 8, and 26: Lattice System Physician's Global Assessment (LS-PGA) and Dermatology Quality of Life Index (DLQI). DISCUSSION: This trial tests of whether an app can improve rates of adherence to a topical antipsoriatic drug. If the app improves rates of adherence and reduces the burden of psoriasis in a clinically significant way, the app could easily be implemented as a standard routine of care in the clinic. TRIAL REGISTRATION: NCT02858713 , registered on August 3, 2016. EudraCT number 2016-002143-42.

A novel mutation in the EDAR gene causes severe autosomal recessive hypohidrotic ectodermal dysplasia.

We report on a 2-year-old girl presenting with a severe form of hypohidrotic ectodermal dysplasia (HED). The patient presented with hypotrichosis, anodontia, hypohidrosis, frontal bossing, prominent lips and ears, dry, pale skin, and dermatitis. The patient had chronic rhinitis with malodorous nasal discharge. The girl was the second born child of first-cousin immigrants from Northern Iraq. A novel homozygous mutation (c.84delC) in the EDAR gene was identified. This mutation most likely causes a frameshift in the protein product (p.S29fs*74). This results in abolition of all ectodysplasin-mediated NF-kB signalling. This complete loss-of-function mutation likely accounts for the severe clinical abnormalities in ectodermal structures in the described patient.

A retrospective study of clinical and mutational findings in 45 Danish families with ectodermal dysplasia.

Ectodermal dysplasias form a complex, nosologic group of diseases with defects in at least 2 ectodermal structures. A retrospective study of patients with ectodermal dysplasia seen at our department over a period of 19 years (1994-2013) was performed. The study population consisted of 67 patients covering 17 different diagnoses. Forty-five families were identified of which 26 were sporadic cases with no affected family members. In 27 tested families a disease-causing mutation was identified in 23 families. Eleven mutations were novel mutations. To our knowledge, we present the first large ectodermal dysplasia cohort focusing on clinical manifestations in combination with mutational analysis. We recommend a nationwide study to estimate the prevalence of the ectodermal dysplasia and to ensure relevant molecular genetic testing which may form the basis of a national ectodermal dysplasia database.

[Scaling skin in infancy]. / Schuppende Hautveränderungen im Säuglingsalter.

An infant was admitted to the neonatal intensive care unit due to a noticeable desquamation of the skin in the groin, extremities and axillary regions. In addition to the desquamation the baby had a collodion membrane. Microbiological swabs taken of the affected areas, however, did not show any microbial growth. Even in the molecular analysis, no common mutation for congenital ichthyoses could be found. The self-healing collodion baby (SHCB) is one subtype of autosomal recessive inherited ichthyoses. In mild courses watchful waiting and a moisturizing cream is justified.

Pros and cons of eHealth: A systematic review of the literature and observations in Denmark.

OBJECTIVES: The main objectives of this article are to systematically review the recent literature on patient safety in relation to the use of eHealth and to investigate how the Danish authorities supervise private eHealth clinics with regard to patient safety. METHODS: Original studies reporting the association between patient safety and the use of eHealth as a means of communication between patients and healthcare providers were included. Four literature databases were searched for English-language articles reporting results from cohort studies and clinical trials, published from 2015 until March 2021. Moreover, registered private eHealth clinics in Denmark were evaluated with reference to a recent national audit of patient safety issues in eHealth. RESULTS: The literature search retrieved four intervention studies. The studies did not identify any particular patient safety risks associated with the use of eHealth. Many different authorized healthcare providers (preferably, doctors) apply eHealth in various contexts. eHealth is being used as the only form of contact between the healthcare provider and the patient, as a supplement to patient visitations in an outpatient clinic, or as a tool for communicating between two or more healthcare providers. The regulation of eHealth involves patient safety issues but also has interfaces to marketing, IT systems, and infrastructure. Supervision of eHealth includes the organization of clinics, handling patient charts, prescription medicine, patient legal rights, and patient transition. However, there are many interfaces in the division of responsibilities among the various governmental players. CONCLUSION: eHealth is being used increasingly and in many settings, although recently published intervention studies investigating patient safety issues by the use of eHealth are limited. A structured and continuous governmental control and regulation of patient safety in relation to the use of eHealth is warranted.

Long-term improvement of psoriasis patients' adherence to topical drugs: testing a patient-supporting intervention delivered by healthcare professionals.

BACKGROUND: Psoriasis affects 2-4% of the Western adult population and is a socio-economic burden for patients and society. Topical drugs are recommended as first-line treatment for mild-to-moderate psoriasis, but low adherence is a barrier to treatment success. Psoriasis patients require support, in order to improve their long-term use of topical drugs. The project aims to test whether a patient-supporting intervention delivered by dermatology nurses can reduce the severity of psoriasis, improve the use of topical drugs, and is cost-effective compared to standard procedure. METHODS: The intervention consists of improved support delivered to patients by three experienced dermatology nurses, who will support patients on a regular basis by consultations with a focus on providing reminder systems, accountability, reinforcement, and building trust in the treatment. Each patient will be supported by the same dermatology nurse throughout the entire study period. The effect will be compared with standard procedure. The intervention will be tested in a randomized controlled trial during a 48-week period. A group of patients with moderate-to-severe psoriasis (psoriasis affecting ≥ 4% of the total body surface area) and 18-85 years of age who are prescribed topical treatment will be randomized to a non-intervention (n ≈ 57) or intervention group (n ≈ 57). Participants in both arms will be prescribed topical preparations containing corticosteroid and/or calcipotriol. The primary outcome will be a change in the severity of psoriasis, measured as reduction in the Lattice-System Physician's Global Assessment. Secondary outcomes will include changes in health-related quality of life (measured by disease specific and generic questionnaires), primary adherence (i.e., proportion of filled prescriptions), and secondary adherence by objective measure (rate of topical drug consumption (obtained by weighing medication packages) compared to estimated recommended consumption). A health economic evaluation is planned to run alongside the trial. Participants' total health costs will be estimated on the basis of health costs reported to the national health registries and costs spent on the intervention, after which a cost-utility and cost-effectiveness analysis will be carried out. DISCUSSION: If the intervention can reduce the severity of psoriasis in a significant manner and is economically favorable compared to standard treatment, there is potential for implementing the intervention in dermatology clinics. TRIAL REGISTRATION: Clinicaltrials.gov NCT04220554 . Registered on January 7, 2020. Study results, either positive, negative, or inconclusive, will be published on www.clinicaltrials.gov . Trial registration no. with the Danish Regional Committee on Health Research Ethics, registration no. 72613.

Dermatology nurses view on factors related to Danish psoriasis patients' adherence to topical drugs: a focus group study.

BACKGROUND: Topical medications are first-line treatment for mild-to-moderate psoriasis, but adherence is low, which negatively affects patients' outcomes and quality of life. Nurses can play a central role in patient care, particularly in improving adherence. OBJECTIVES: To explore the experience of dermatology nurses with psoriasis patients' adherence to topical drugs. METHODS: We conducted a semi-structured focus group study with 6 dermatology nurses and 2 dermatology nursing students. Participants were recruited from a dermatology hospital outpatient clinic. Data were analyzed by a systematic text condensation method with a phenomenological-hermeneutic approach. RESULTS: Nurses experienced that factors such as social inequality, patient-centered nursing, and patients' quality of life can have an influence on adherence. CONCLUSION: Optimal adherence to topical treatments is a complex exercise and is influenced by many different factors. Involving nurses when prescribing topical treatments may be beneficial since they are one of the most trustworthy professions and have a holistic view on psoriasis severity, patient preferences, health care resources available and socioeconomic factors.

Psoriasis patient preferences for topical drugs: a systematic review.

BACKGROUND: Topical drugs are recommended first-line treatment for mild-to-moderate psoriasis. However, patient preferences for the topical drugs differ, since a wide variety of topical drugs and topical drug formulations are available. OBJECTIVES: The aim of this study was to investigate psoriasis patient preferences for topical drugs. METHODS: A systematic literature search was performed for English-language articles in Embase, Medline, PsycINFO, Cinahl, Scopus, and the Cochrane Library. RESULTS: Four surveys, six randomized controlled trials, and two prospective studies of mainly good quality were included. Seven of the studies investigated patient preferences for topical drug formulations, while five studies investigated their preferences for different topical drugs. Overall, patients preferred drugs that are easy to apply, less messy, and have a pleasant scent. CONCLUSION: Psoriasis patient preferences for topical drugs differ. There is no one topical drug or topical drug formulation that suits everyone, which shows the importance of individualized prescriptions for topical drugs that are based on shared decision-making between the prescriber and patient.

Improving psoriasis patients' adherence to topical drugs: a systematic review.

Background: Poor adherence to topical antipsoriatic drugs limits treatment effectiveness.Objective: The aim of this study was to investigate how health care providers may improve psoriasis patients' adherence to topical treatment.Materials and methods: A systematic literature search was performed for English-language articles in Embase, Medline, PsycINFO, Cinahl, Scopus, and the Cochrane Library.Results: Ten studies of varying quality were identified. Two randomized controlled trials (RCTs) testing the adherence-improving potential of interventions by health care providers to support patients showed improvement in adherence to topical treatment. In a prospective study with a pre/postdesign, an individualized, face-to-face consultation reported an improvement in patient-reported adherence to topical treatment over a 9-week period. Based on seven qualitative studies obtaining insights from either patients or health care providers, health care providers may need to address socio-economic factors, health care system factors, and treatment-, patient-, and disease-related factors in interventions that aim to improve the adherence of psoriasis patients to topical antipsoriatic drugs.Conclusion: There is a need to develop better adherence-improving interventions. A good patient-health care provider relationship is considered crucial to adherence and may be an important intervention target. Before interventions to improve adherence to topicals can be recommended for the clinic, the intervention should be tested in high-quality RCTs.