Quality of life measurement in assessing treatment effectiveness in urticaria: European experts position statement.

In this study, the European Academy of Dermatology and Venereology (EADV) Task Forces on Quality of Life and Patient-Oriented Outcomes and Urticaria and Angioedema has examined the Health-Related Quality of Life (HRQoL) measurement in the treatment of urticaria. The Dermatology Life Quality Index was the most frequently used HRQoL instrument in clinical trials on urticaria. Many reports of clinical trials of urticaria gave no exact numeric results related to HRQoL changes, making clear conclusions and comparisons with other studies impossible. The interpretation of HRQoL impairment data is more difficult when assessed by instruments without severity stratification systems. The minimal clinically significant difference (MCID) is a more clinically oriented and relevant parameter than depending on statistically significant changes in HRQoL scores. Therefore, using HRQoL instruments with established MCID data in clinical trials and clinical practice is preferred.

Physician resilience and perceived quality of care among medical doctors with training in psychosomatic medicine during the COVID-19 pandemic: a quantitative and qualitative analysis.

BACKGROUND: At an individual level, physician resilience protects against burnout and against its known negative effects on individual physicians, patient safety, and quality of care. However, it remains uncertain whether physician resilience also correlates with maintaining a high level of healthcare quality during crises such as a pandemic. This study aimed to investigate whether higher resilience among physicians, who had received training in resilience-related competences in the past, would be associated with higher quality of care delivered during the COVID-19 pandemic. METHODS: This study enrolled physicians working in family medicine, psychiatry, internal medicine, and other medical specialties, who had obtained at least one of three consecutive diplomas in psychosomatic medicine in the past. Participants completed a quantitative and qualitative anonymous online survey. Resilience was measured using the Connor-Davidson Resilience Scale, and healthcare quality was assessed through single-item quality indicators, including perceived quality of care, professional autonomy, adequate time for patient care, and job satisfaction. RESULTS: The study included 229 physicians (70 males/159 females) with additional training in psychosomatic medicine, working in family medicine (42.5%), psychiatry (28.1%), internal medicine (7.0%), or other medical specialties (22.4%). Participants represented four intensity levels of training background (level 1 to level 4: 9.2%, 32.3%, 46.3%, and 12.2% of participants). Training background in psychosomatic medicine was positively associated with resilience (B = 0.08, SE = 0.04, p <.05). Resilience and training background independently predicted perceived quality of care, even after controlling for variables such as own health concerns, involvement in the treatment of COVID-19 patients, financial strain, percentage of working hours spent on patient care, age, and gender (resilience: B = 0.33, SE = 0.12, p <.01; training background: B = 0.17, SE = 0.07, p <.05). Both resilience and training background predicted job satisfaction (resilience: B = 0.42, SE = 0.12, p <.001; training background: B = 0.18, SE = 0.07, p <.05), while resilience alone predicted professional autonomy (B = 0.27, SE = 0.12, p <.05). In response to an open question about their resources, resilient physicians more frequently reported applying conscious resilient skills/emotion regulation (p <.05) and personal coping strategies (p <.01) compared to less resilient medical doctors. CONCLUSION: Physician resilience appears to play a significant role in the perceived quality of patient care, professional autonomy, and job satisfaction during healthcare crises.

Quality of life measurement in vitiligo. Position statement of the European Academy of Dermatology and Venereology Task Force on Quality of Life and Patient Oriented Outcomes with external experts.

Members of the European Academy of Dermatology and Venereology (EADV) Task Force on Quality of Life (QoL) and Patient Oriented Outcomes reviewed the instruments available for health-related (HR) QoL assessment in vitiligo and together with external vitiligo experts (including representatives of the EADV Vitiligo Task Force) have made practical recommendations concerning the assessment of QoL in vitiligo patients. The Dermatology Life Quality Index (DLQI) was the most frequently used HRQoL instrument, making comparison of results between different countries possible. Several vitiligo-specific instruments were identified. The vitiligo Impact Scale (VIS) is an extensively validated vitiligo-specific HRQoL instrument with proposed minimal important change and clinical interpretation for VIS-22 scores. VIS-22 was developed for use in India, where there are some specific cultural beliefs concerning vitiligo. The EADV Task Force on QoL and Patient Oriented Outcomes recommends use of the DLQI and the Children's Dermatology Life Quality Index (CDLQI) as dermatology-specific instruments in vitiligo. There is a strong need for a valid (including cross-cultural validation) vitiligo-specific instrument that can be either a new instrument or the improvement of existing instruments. This validation must include the proof of responsiveness.

Facial atopic dermatitis may be exacerbated by masks: insights from a multicenter, teledermatology, prospective study during COVID-19 pandemic.

BACKGROUND: Patients with atopic dermatitis (AD) display a defective skin barrier, consequently they may experience inflammatory flares with different exposures, including masks. Actually, beside scattering case reports, no study focused on the possible AD flaring due to masks. METHODS: In this multicenter prospective study AD patients with facial manifestation were followed with teledermatology and evaluated by two board-certified dermatologists at the baseline (T0) and after 1 month (T1) in which patients started to wear masks >6 hours per day. Demographics and clinical parameters, included and not limited to Eczema Area and Severity Index (EASI) and Dermatology Life Quality Index (DLQI), were carefully collected and analyzed. RESULTS: We enrolled 57 AD patients (M/F 28/29, 33.91±12.26 years old) that wore surgical masks (38 [66.7%]), community masks (11 [19.3%] and N95 (8 [14.0%]). Both DLQI and EASI increase during the time period (P<0.0001). DLQI variation was not influenced by age, BMI, and gender, mask type used and AD therapy (P=0.99), whilst EASI variation was significantly influenced by BMI, gender, and therapy (P=0.004). CONCLUSIONS: Mask wearing may prove detrimental to patients with atopic eczema and the same may not necessarily be the case for asthma patients.

Masks trigger facial seborrheic dermatitis and psoriasis: evidence from a multicenter, case-control study during COVID-19 pandemic.

BACKGROUND: Wearing masks is an optimal preventive strategy during COVID-19 pandemic, but it may increase facial sebum production. However, few case reports have described seborrheic dermatitis (SeBD) and psoriasis (PsO) flares due to masks. Hence, we conducted a multicenter study to clarify the possibility of increased SeBD and PsO flares in association with mask wearing during the COVID-19 pandemic. METHODS: This multicenter study enrolled patients with a diagnosis of facial SeBD and PsO. All dermatological consultations were conducted in teledermatology at baseline (T0) and after 1 month (T1) Of >6 hours/day wearing mask. PsO patients were assessed using PsO Area and Severity Index (PASI) and self-administered PASI (SAPASI), whilst SeBD patients with symptom scale of seborrheic dermatitis' (SSSD) and seborrheic dermatitis area and severity index (SEDASI). RESULTS: A total of 33 (20 males, 13 females, average age 43.61±9.86) patients with PsO and 33 (20 males, 13 females, average age 44.00±8.58) with SeBD were enrolled. After 1 month, PsO patients displayed higher values of both PASI and SAPASI (P<0.0001), while SeBD patients experienced a flare, as testified by the increment of both SSSD and SEDASI (P<0.0001). Mask type did not seem to influence the flare severity. CONCLUSIONS: Masks remain an optimal preventive strategy during COVID-19 pandemic, but patients with PsO and SeBD may experience facial flares. Thus, therapeutic approach should be more aggressive in these groups of patients to counteract the triggering effect of masks.

Development of a visual tool to assess six dimensions of health and its validation in patients with endocrine disorders.

BACKGROUND: Psychosocial factors significantly influence patient care in many fields of medicine, among these in the field of endocrinology. Easily applicable validated assessment tools for such psychosocial factors are lacking. Visual instruments may facilitate doctor-patient communication. This study describes the development and validation of a multidimensional visual tool for the self-assessment of health. METHODS: An expert panel performed the multistep development of the psychosomatic assessment health disc (PAHD). Assessment of face validity was performed by means of a focus group of medical doctors (n = 6) and patient interviews (n = 24). For determining test-retest reliability, internal consistency and construct validity, patients of an endocrine outpatient clinic in Graz, Austria, completed the PAHD and the following questionnaires: short-form 36 health survey, work ability index, Pittsburgh sleep quality index and the social life scales of the life satisfaction questionnaire. RESULTS: A numeric six-item analogue scale was developed in the form of a disc. It addresses the following aspects of health: physical well-being, social life, sexuality, mental well-being, sleep, working ability/performance. For the validation process, 177 patients (57.1% females) participated in the study. Correlation coefficients of the six items with other questionnaires ranged between r = 0.51 (social life) and r = 0.72 (sleep). Test-retest reliability was assessed among 98 patients and was ≥ 0.74 for all 6 items, while Cronbach's alpha was 0.78. CONCLUSION: The psychometric properties of the PAHD support its use in clinical encounters with patients suffering from endocrine disorders. Further validation studies may be required to extend its application to other fields of medicine.

Interpreting physical sensations to guide health-related behavior : An introductory review on psychosomatic competence.

From a biopsychosocial perspective, maintaining health requires sufficient autoregulatory and self-regulatory capacity to both regulate somatic physiology and manage human-environment interactions. Increasing evidence from neuroscientific and psychological research suggests a functional link between so called interoceptive awareness and self-regulatory behavior. Self-regulation can, again, influence autoregulatory patterns as it is known from biofeedback training or meditation practices. In this review, we propose the psychosomatic competence model that provides a novel framework for the interrelation between interoceptive and self-regulatiory skills and health behavior. The term psychosomatic competence refers to a set of mind- and body-related abilities which foster an adequate interpretation of interoceptive signals to drive health-related behavior and physical well-being. Current related empirical findings and future directions of research on interoception and self-regulation are discussed.

Masks use and facial dermatitis during COVID-19 outbreak: is there a difference between CE and non-CE approved masks? Multi-center, real-life data from a large Italian cohort.

BACKGROUND: During the recent COVID-19 outbreak, masks became mandatory and shortages frequent, therefore the prevalence of non-CE (European Conformity Mark) approved masks increased in the general population. We aimed to quantify the prevalence of mask-related cutaneous side effects and the differences between CE and non-CE approved masks. METHODS: In this multicenter prospective observational study conducted from March 20, 2020 to May 12, 2020(during and after quarantine), patients attending emergency departments for a dermatological consult were clinically assessed and their masks were inspected to detect CE marks and UNI (Italian National Unification Entity) norms. Patients with history of facial dermatoses or under current treatment for facial dermatoses were excluded. RESULTS: We enrolled 412 patients (318 during quarantine and 94 after quarantine). CE-approved masks were observed 52.8% vs. 24.5%, whilst subsets of non-CE approved masks were 9.7% vs. 14.9% (Personal protective equipment (PPE)-masks), 16.4% vs. 12.8% (surgical masks [SM]), and 21.1% vs. 47.9%(non-PPE) and (non-SM masks), respectively during and after quarantine. Remarkably, non-CE-approved masks resulted in patients displaying a statistically significant higher incidence of facial dermatoses and irritant contact dermatitis compared to CE-approved masks, and these differences were mainly driven by non-PPE non-SM masks. Comparing quarantine and after quarantine periods, no statistically significant differences were found for CE-approved masks, whilst differences were detected in non-CE-approved masks regarding incidence of facial dermatoses (P<0.0001)and irritant contact dermatitis (P=0.0041). CONCLUSIONS: Masks are essential to prevent COVID-19 but at the same time higher awareness regarding mask specifications should be promoted in the general population. Non-PPE and non-SM masks should undergo more rigorous testing to prevent the occurrence of cutaneous side effects and future patients' lawsuit damages.

Predicting Secukinumab Fast-Responder Profile in Psoriatic Patients: Advanced Application of Artificial-Neural-Networks (ANNs).

BACKGROUND: Drug resistance to biologics in psoriasis therapy can occur – it may be acquired during a treatment or else present itself from the beginning. To date, no biomarkers are known that may reliably guide clinicians in predicting responsiveness to biologics. Biologics may pose a substantial economic burden. Secukinumab efficiently targets IL-17 in the treatment of psoriasis. OBJECTIVE: To assess the “fast responder” patient profile, predicting it from the preliminary complete blood count (CBC) and clinical examination. MATERIALS AND METHODS: From November 2016 to May 2017 we performed a multicenter prospective open label pilot study in three Italian reference centers enrolling bio-naive plaque psoriasis patients, undergoing the initiation phase secukinumab treatment (300mg subcutaneous at week 0,1,2,3,4). We define fast responders as patients having achieved at least PASI 75 at the end of secukinumab induction phase. Clinical and CBC data at week 0 and at week 4 were analyzed with linear statistics, principal component analysis, and artificial neural networks (ANNs), also known as deep learning. Two different ANNs were employed: Auto Contractive Map (Auto-CM), an unsupervised ANNs, to study how this variables cluster and a supervised ANNs, Training with Input Selection and Testing (TWIST), to build the predictive model. RESULTS: We enrolled 23 plaque psoriasis patients: 19 patients were responders and 4 were non-responders. 30 attributes were examined by Auto-CM, creating a semantic map for three main profiles: responders, non-responders and an intermediate profile. The algorithm yielded 5 of the 30 attributes to describe the 3 profiles. This allowed us to set up the predictive model. It displayed after training testing protocol an overall accuracy of 91.88% (90% for responders and 93,75% for non-responders). CONCLUSIONS: The present study is possibly the first approach employing ANNs to predict drug efficacy in dermatology; a wider use of ANNs may be conducive to useful both theoretical and clinical insight. J Drugs Dermatol. 2020;19(12) doi:10.36849/JDD.2020.5006.

Skin and Psychosomatics - Psychodermatology today.

Modern psychodermatology relies on the bio-psycho-social disease model in psychosomatics, according to which biological, psychological and social factors (on various levels, from molecules to the biosphere) play a major role in the disease pathogenesis through complex, non-linear interactions over the entire disease course. It is nowadays experimentally proven that "emotions get into the skin". Recent research shows close anatomical, physiological and functional connections between skin and nervous system, already known to be ontogenetically related. These connections are reflected in many skin diseases where psychological and somatic etiological factors are closely intertwined. A holistic approach by the physician should do justice to this interdependence; biological, psychological and social factors should be adequately taken into account when taking anamnesis, making a diagnosis and choosing a therapy. The "visibility" of the skin organ bestows dermatology a special position among the various other clinical subjects, and renders a holistic, psychosomatic approach to the patient that is particularly important. The life course belongs also to modern psychodermatological approaches. Based on the modern psychodermatology concept, other corresponding sub-areas such as psychogastroenterology, psychocardiology etc. have emerged. After the theoretical part of this article, some selected skin diseases are discussed in more detail from the psychosomatic point of view.

Psoriasis and Dementia: A Cross-sectional Study of 121,801 Patients.

Data regarding the association between psoriasis and dementia are inconclusive. The aim of this study was to evaluate this association in the database of Clalit Health Services, Israel. A comparative analysis for the association between psoriasis, dementia and its risk factors was performed for the entire study population and in the subgroup of patients with moderate-to-severe psoriasis. The study included 121,801 patients with psoriasis, of whom 16,947 were diagnosed with moderate-to-severe psoriasis, and 121,802 controls. Psoriasis was associated with a lower prevalence of dementia relative to control subjects (1.6% vs 1.8%; odds ratio (OR) 0.85; 95% confidence interval (95% CI) 0.80-0.91; p < 0.001). Multivariate analysis adjusting for demographic variables, cardiovascular-related risk factors, and healthcare utilization demonstrated a significant inverse association between psoriasis and dementia in the entire study population (adjusted OR 0.86; 95% CI 0.76-0.96; p = 0.009), but not in the subgroup of patients with moderate-to-severe psoriasis (adjusted OR 0.91; 95% CI 0.81-1.02; p = 0.113). In conclusion, these data support the hypothesis that psoriasis is inversely associated with dementia.

Exploring the EQ-5D Dimension of Pain/Discomfort in Dermatology Outpatients from a Multicentre Study in 13 European Countries.

Pain and discomfort are important symptoms in dermatology. The aim of this cross-sectional, multicentre study was to describe the prevalence of pain/discomfort and its associations in patients with several dermatological conditions across 13 European countries. The outcome was the prevalence of pain/discomfort according to a question of the EQ-5D questionnaire. Data collected from November 2011 to February 2013 were complete for 3,509 consecutive outpatients. Moderate or extreme pain/discomfort was reported by 55.5% of patients and 31.5% of controls with no skin conditions. The highest proportions were reported by patients with hidradenitis suppurativa (92.9%), leg ulcer (81.4%), prurigo (80%) and lichen planus (75.6%). Pain/discomfort was associated with older age, low educational level, clinical severity, flare on scalp or hands, itch, depression, anxiety, low quality of life, and thoughts of suicide. It is important to enquire specifically about pain/discomfort during clinical consultations and to address it when planning a patient's care.

Psychosocial Aspects of Adult Acne: Data from 13 European Countries.

The link between acne and psychiatric morbidities has been demonstrated in many studies; however, large scale studies aiming to reveal the psychosocial impact of acne are rare. The aim of this study was to assess the psychological burden of adult acne patients. This analysis was based on a multicenter study including 213 acne patients and 213 controls from 13 European countries. The Hospital Anxiety and Depression Scale (HADS), Dermatology Life Quality Index, and EuroQol 5 dimensions 3 levels scores of the patients with acne were analyzed. Patients with acne (n = 213) had higher HADS scores for anxiety (mean ± standard deviation 6.70 ± 3.84) and depression (3.91 ± 3.43) than the controls (p < 0.001 for both). For patients with acne, 40.6% reported that they were very concerned about their skin disease, 12.3% had suicidal ideation, and, among those, 10 (4%) patients implied that acne was the cause of their suicidal thoughts. After adjusting for other variables, patients who had suicidal ideation (p = 0.007, and adjusted odds ratio 3.32 [95% confidence interval (CI): 1.39-7.93]) and stressful life events (p < 0.001, and adjusted OR 5.85 [95% CI: 2.65-12.86]) had a greater chance of fulfilling the HADS criteria for anxiety. This study highlights the need for a psychotherapeutic approach in order to recognize the concerns of acne patients and optimize their treatment.

Itch and Mental Health in Dermatological Patients across Europe: A Cross-Sectional Study in 13 Countries.

Itch is a highly prevalent and multidimensional symptom. We aimed to analyze the association between itch and mental health in dermatological patients. This multicenter study is observational and cross-sectional and was conducted in dermatological clinics across 13 European countries. A total of 3,530 patients and 1,094 healthy controls were included. Patients were examined clinically. Outcome measures were itch (presence, chronicity, and intensity), the Hospital Anxiety and Depression Scale, EQ-5D visual analogue scale, sociodemographics, suicidal ideation, and stress (negative life events and economic difficulties). Ethical approval was obtained. Results showed significant association between the presence of itch in patients and clinical depression (odds ratio, 1.53; 95% confidence interval, 1.15-2.02), suicidal ideation (odds ratio, 1.27; 95% confidence interval, 1.01-1.60), and economic difficulties (odds ratio, 1.24; 95% confidence interval, 1.10-1.50). The mean score of reported generic health status assessed by the EQ-5D visual analogue scale was 65.9 (standard deviation = 20.1) in patients with itch, compared with 74.7 (standard deviation = 18.0) in patients without itch (P < 0.001) and 74.9 (standard deviation = 15.7) in controls with itch compared with 82.9 (standard deviation = 15.6) in controls without itch (P < 0.001). Itch contributes substantially to the psychological disease burden in dermatological patients, and the management of patients should include access to multidisciplinary care.

Nanodermatology-based solutions for psoriasis: State-of-the art and future prospects.

Nanodermatology is an emerging, multidisciplinary science, arising from the convergence of nanotechnology, pharmacology, physics/biophysics, chemistry/biochemistry, chemical engineering, material science, and clinical medicine. Nanodermatology deals with (a) skin biology, anatomy, and physiology at the nanoscale ("skin nanobiology"), (b) diagnosis performed by means of novel diagnostic devices, assisted by nanobiotechnologies ("nanodiagnosis"), and (c) treatment through innovative therapeutic agents, including phototherapy ("photonanotherapy"/"photonanodermatology") and systemic/topical drug administration ("nanotherapy") at the nanoscale, and drug delivery-such as transdermal or dermal drug delivery (TDDD/DDD)-enhanced and improved by nanostructures and nanodrugs ("nanodrug delivery"). Nanodermatology, as a super-specialized branch of dermatology, is a quite recent specialty: the "Nanodermatology Society" founded by the eminent dermatologist Dr. Adnan Nasir, was established in 2010, with the aim of bringing together different stakeholders, including dermatologists, nanotechnology scientists, policy-makers and regulators, as well as students and medical residents. Psoriasis has a prevalence of 2-3% worldwide and imposes a severe clinical and societal burden. Nanodermatology-based solutions appear promising for the proper treatment and management of psoriasis, assisting and enhancing different steps of the process of health-care delivery: from the diagnosis to the therapeutics, paving the way for a personalized approach, based on the specific dysregulated biomarkers.