Angioedema quality of life questionnaire (AE-QoL) - interpretability and sensitivity to change

BACKGROUND: The Angioedema Quality of Life (AE-QoL) is the first patient reported outcome measure developed for the assessment of quality of life (QoL) impairment in patients with recurrent angioedema (RAE). This study aimed to evaluate the clinimetric properties of the AE-QoL in Thai patients and to establish categories of QoL impairment assessed by the AE-QoL. METHODS: The validated Thai version of the Dermatology Life Quality Index (DLQI) and Patient Global Assessment of Quality of Life (PGA-QoL) were used to comparatively evaluate the Thai version of AE-QoL. Spearman correlations between the Thai AE-QoL and two other standard measurements (DLQI and PGA-QoL) were investigated to determine convergent validity. The Thai DLQI and PGA-QoL were used to categorize patients according to their QoL. Known-group validity of the Thai AE-QoL was later analyzed. The reliability of the Thai AE-QoL was investigated using Cronbach's alpha and intraclass correlation. Three different approaches including the distribution method, receiver operating characteristic curve analysis, and the anchor based-method were used for the interpretability. RESULTS: A total of 86 patients with RAE with a median age of 38.0 ± 15.1 years (range 18-76) were enrolled. Of those, 76 patients (88%) had RAE with concomitant wheals, and 10 patients (11.6%) had RAE only. The AE-QoL assessed RAE-mediated QoL impairment with high convergent validity and known-groups validity, high internal consistency and test-retest reliability, and good sensitivity to change. Although the AE-QoL did not differentiate between patients with moderate and large effect as measured by PGA-QoL or DLQI in this study, AE-QoL total values of 0-23, 24 to 38, and ≥ 39 could define patients with "no effect", "small effect", and "moderate to large effect" of RAE on their QoL, respectively. CONCLUSIONS: This study supports the validity and reliability of the Thai version of the AE-QoL, which is a very different language from the original version. Categories allow to classify the effect of RAE on patients' QoL as "none", "small", and "moderate to large". Further studies are needed to confirm the applicability of AE-QoL in other Asian populations"

Validity, reliability and interpretability of the Thai version of the urticaria control test (UCT)

Background The Long Form and Short Form of the German (original) version of the Urticaria Control Test (UCT) have shown to be valid and reliable instruments for assessing patients with all types of chronic urticaria (CU). The cutoff scores for identifying patients with well-controlled disease were ≥ 24 and ≥ 12 for Long and Short Forms, respectively. However, the sensitivity to change and minimal clinically important difference (MCID) of the UCT have never been systematically evaluated. This study aimed to investigate the validity, reliability, screening accuracy, sensitivity to change and MCID of the linguistically validated translation of the UCT into the Thai language for assessing CU in the Thai population. Methods A structured translation and pre- testing were done to cross-culturally adapt the UCT for the Thai language. All measurement properties of both forms of the Thai UCT were validated in 169 patients with CU. Results There were strong correlations between the Thai UCT score and disease activity, health-related quality of life impairment, and disease control (all correlations ≥ 0.7). Good internal consistency and excellent intra-rater reliability were demonstrated. The same cutoff scores to define patients with well-controlled disease should be used as those recommended for the original UCT version. MCIDs equated to increase in scores of 6 and 3 for the Long and Short Forms, respectively, of the Thai UCT should be used to identify patients who had minimal responses. Score increments of ≥10 and ≥ 6 for Long and Short Forms, respectively, should be used to define patients who had marked responses. Conclusions This study confirmed the applicability of the UCT for use in Thailand, a country that has a very different language and cultural setting than that of Germany and the United States. Further studies are required to examine the suitability of the UCT for use in the pediatric population

Prevalence of chronic urticaria in children and adults across the globe: Systematic review with meta‐analysis

Background and objectives: Urticaria is a frequent skin condition, but reliable prevalence estimates from population studies particularly of the chronic form are scarce. The objective of this study was to systematically evaluate and summarize the prevalence of chronic urticaria by evaluating population-based studies worldwide. Methods: We performed a systematic search in PUBMED and EMBASE for population-based studies of cross-sectional or cohort design and studies based on health insurance/system databases. Risk of bias was assessed using a specific tool for prevalence studies. For meta-analysis, we used a random effects model. Results: Eighteen studies were included in the systematic evaluation and 11 in the meta-analysis including data from over 86 000 000 participants. Risk of bias was mainly moderate, whereas the statistical heterogeneity (I-2) between the studies was high. Asian studies combined showed a higher point prevalence of chronic urticaria (1.4%, 95%-CI 0.5-2.9) than those from Europe (0.5%, 0.2-1.0) and Northern American (0.1%, 0.1-0.1). Women were slightly more affected than men, whereas in children < 15 years we did not find a sex-specific difference in the prevalence. The four studies that examined time trends indicated an increasing prevalence of chronic urticaria over time. Conclusions: On a global level, the prevalence of chronic urticaria showed considerable regional differences. There is a need to obtain more sex-specific population-based and standardized international data particularly for children and adolescents, different chronic urticaria subtypes and potential risk and protective factors

Efficacy and safety of on-demand versus daily rupatadine in chronic spontaneous urticaria: A randomized trial

Chronic spontaneous urticaria; On-demand; RupatadineUrticaria crónica espontánea; Bajo demanda; RupatadinaUrticària crònica espontània; Sota demanda; RupatadinaBackground Non-sedating H1-antihistamines (nsAH) are the most commonly used treatment for chronic spontaneous urticaria (CSU). Many patients use them as on-demand (OD) therapy rather than a maintenance treatment. Here, we compared OD versus daily maintenance treatment with the nsAH rupatadine, assessed the efficacy of rupatadine updosing, and investigated potential long-term disease-modifying effects. Methods This multicenter, randomized study consisted of 2 weeks of screening, 8 weeks of double-blind treatment, and 6 weeks of treatment-free follow-up (OD allowed). Adult patients were randomized to 10 mg rupatadine OD or 10 mg rupatadine daily. At Week 4, if patients did not have a complete response, they switched from 10 to 20 mg rupatadine daily or underwent sham updosing (patients on 10 mg rupatadine OD). The primary aim was to compare CSU disease activity at the end of follow-up between daily versus OD. Additionally, we assessed the efficacy of rupatadine updosing. Major outcomes were disease activity, CSU-related quality of life (QoL), and disease control. Results At Week 4, disease activity and QoL significantly improved in daily versus OD-treated patients. Updosing of rupatadine did not improve the mean disease activity, but the number of complete responders increased during updosing from 5% to 22%. At the end of follow-up, the disease activity of patients treated OD versus daily was not significantly different. Conclusions Daily rupatadine treatment significantly improved CSU disease activity and QoL during treatment versus OD treatment but not after discontinuation of rupatadine, indicating the benefits of a daily maintenance nsAH schedule.This study was funded in part by URIACH, and the analysis was funded by Charité—Universitätsmedizin Berlin as part of the “CU-LATER” study. Other features of the study were supported by intramural funding. In addition, this study benefited from the network of Urticaria Centers of Reference and Excellence (UCAREs; https://ga2len-ucare.com) of GA2LEN, the Global Allergy and Asthma European Network

A Core Outcome Set for Efficacy of Acute Treatment of Hereditary Angioedema

Acute treatment; Delphi; Hereditary angioedemaTratamiento agudo; Delphi; Angioedema hereditarioTractament agut; Delphi; Angioedema hereditariBackground Clinical trials investigating drugs for the acute treatment of hereditary angioedema attacks have assessed many different outcomes. This heterogeneity limits the comparability of trial results and may lead to selective outcome reporting bias and a high burden on trial participants. Objective To achieve consensus on a core outcome set composed of key outcomes that ideally should be used in all clinical efficacy trials involving the acute treatment of hereditary angioedema attacks. Methods We conducted a Delphi consensus study involving all relevant parties: patients with hereditary angioedema, hereditary angioedema expert clinicians and clinical researchers, pharmaceutical companies, and regulatory bodies. Two Internet-based survey rounds were conducted. In round 1, panelists indicated the importance of individual outcomes used in clinical trials on a 9-point Likert scale. Based on these results, a core outcome set was developed and voted on by panelists in round 2. Results A total of 58 worldwide panelists completed both rounds. The first round demonstrated high importance scores and substantial agreement among the panelists. In the second round, a consensus of 90% or greater was achieved on a core outcome set consisting of five key outcomes: change in overall symptom severity at one predetermined time point between 15 minutes and 4 hours after treatment, time to end of progression of all symptoms, the need for rescue medication during the entire attack, impairment of daily activities, and treatment satisfaction. Conclusions This international study obtained a high level of consensus on a core outcome set for the acute treatment of hereditary angioedema attacks, consisting of five key outcomes

The Chronic Urticaria Registry: rationale, methods and initial implementation

Background: Chronic urticaria (CU) is a common disease, characterized by the recurrent appearance of wheals, angioedema or both for more than 6 weeks. Its underlying biology is not well understood, and many patients do not obtain sufficient relief from recommended treatments. Patient registries are rapidly growing as a form of research, because they can provide powerful, data-driven insights about the epidemiology of diseases, real-world effectiveness of treatments, rare patient types, safety monitoring, healthcare costs and opportunities for quality improvement of healthcare delivery. Objectives: The Chronic Urticaria Registry (CURE) has been designed to improve the scientific understanding, clinical treatment and healthcare planning of CU patients. This report describes the rationale, methods and initial implementation of this registry. Methods: Chronic Urticaria Registry is an ongoing, prospective, international, multicentre, observational, voluntary registry of patients with CU. Participation in CURE is open to any physician treating CU patients, regardless of location, medical specialty or type of practice setting. CURE aims to collect data on all CU patients, with no intentional selection or exclusion criteria. It collects baseline and follow-up data on the patient's demographics, history, symptoms, trigger and risk factors, therapies and healthcare utilization. Results: Chronic Urticaria Registry is a landmark achievement of the global urticaria medical community. As of 26 February 2020, 39 centres around the world have joined the registry and 35 have entered baseline data on a total of 2946 patients. Publications of this data will be forthcoming soon. Conclusions: Chronic Urticaria Registry is eagerly seeking the participation of more physicians and the support of more governmental, charitable and commercial sponsors from around the world. Here, in this paper, we invite other physicians to join this unique project to improve the lives of patients with CU

Prevalence and factors associated with sleep disturbance in adult patients with psoriasis

Background: Sleep, which is crucial for restoring of physiological functions and health, is reportedly impaired in psoriasis. The role of different potential sleep confounding factors, including detailed pruritus characteristics, and the complex interplay between psychological variables (anxiety and depression), pruritus and sleep disturbance in psoriasis remain insufficiently investigated. Objectives: To investigate sleep characteristics and to identify clinical, demographic and psychological factors associated with sleep disturbance in psoriasis. Methods: This cross-sectional study included 334 psoriasis patients (response rate 86%) and 126 control subjects (response rate 82%). Measures included sleep quality [Pittsburgh Sleep Quality Index (PSQI)], psoriasis severity, pruritus characteristics, including average pruritus intensity [visual analogue scale (VAS)], severity of comorbidities, anxiety and depression (Hospital Anxiety and Depression Scale - HADS) and quality of life (Dermatology Life Quality Index - DLQI, and Short Form 12 - SF12). Results: Fifty-nine per cent of patients and 34% of control subjects (P 5). Patients slept 1 h less than control subjects (median 6 vs. 7 h, P < 0.001). Patients without pruritus had less impaired sleep (global PSQI) than patients with strong (P < 0.001) and very strong pruritus (P < 0.001). Anxiety (HADS-A) and depression (HADS-D) levels were the strongest predictors of sleep impairment, followed by pruritus exacerbation at night, age, female sex, pruritus exacerbation in the morning, average pruritus intensity (VAS), diagnosed depression and gastroesophageal reflux disease, altogether explaining 32%-37% of the variance in global sleep quality. Both anxiety (HADS-A) and depression (HADS-D) were significant mediators explaining the association between pruritus intensity (VAS) and sleep impairment in 42% and 37% respectively. Conclusions: Sleep disturbance in patients with psoriasis is highly prevalent. Patients with psoriasis should be assessed for sleep impairment, pruritus, anxiety and depression. Reduction in pruritus should be considered as an important therapeutic goal, along with therapies aimed at reducing anxiety and depression

Epidemiology, comorbidities, and healthcare utilization of patients with chronic urticaria in Germany

Background: Comprehensive data on the epidemiology and comorbidities of chronic urticaria (CU) in Germany are either limited, or not contemporary. Objectives: To investigate the epidemiology of CU, overall comorbidities and healthcare resource utilized by patients with CU in Germany, using an anonymized statutory health insurance (SHI) database. Methods: Anonymized SHI claims research database of the Institute for Applied Health Research, Berlin [InGef] (01 January 2015-30 September 2018) was used to analyse insured individuals with a confirmed diagnosis of CU (ICD-10-GM codes). Twelve-month diagnosed prevalence and incidence, comorbidities (vs. atopic dermatitis and psoriasis), and healthcare utilization by patients with CU were investigated. Results: Of 4 693 772 individuals of all ages listed in the database, 3 538 540 were observable during 2017. Overall, 17 524 patients (˜0.5%) were diagnosed with CU; chronic spontaneous urticaria (CSU: 71.2%), chronic inducible urticaria (CIndU: 19.7%), CSU+CIndU (9.1%). Females, vs. males, had higher diagnosed prevalence (0.62% vs. 0.37%) and diagnosed incidence (0.18% vs. 0.11%) of CU among all patients. Patients most frequently visited general practitioners (41.3% of total visits). Hypertensive diseases (43.5%), lipoprotein metabolism disorders (32.1%) and affective disorders (26.0%) were the most frequently reported comorbidities of special interest. Rates of most comorbidities of special interests were similar to atopic dermatitis and psoriasis patients, and all higher vs. overall population. More than half (54.1%) of all CU patients were not prescribed any treatment. Second-generation H1 -antihistamines were the most commonly prescribed medication for adult (17.9%) and paediatric (27.9%) patients. Patients with CIndU (paediatric, 15.5%; adult, 7.8%) were more often hospitalized versus patients with CSU (paediatric, 9.9%; adult, 4.6%). Conclusions: In Germany, prevalence of CU along with multiple comorbidities may pose increased burden on the healthcare system. Awareness of adhering to treatment guidelines, and aiming for complete control of urticaria, needs to be driven and may improve outcomes

Evaluation of the Reliability and Validity of the Persian Version of Urticaria Control Test (UCT)

The urticaria control test (UCT) is a patient-reported outcome measure (PROM) for chronic urticaria (CU) patients. As a Persian version of the UCT was not available, the present research aimed to develop such a version, to test its reliability and validity as well as to evaluate urticaria control among Persian-speaking patients. This research was conducted at the Urticaria Centre of Reference and Excellence (UCARE) of Ghaem Hospital, Mashhad, Iran. In a first step, a linguistically validated Persian version of the UCT was developed through a structured forward and backward translation process and subsequent cognitive debriefing interviews. In a second step, the Persian version of the UCT was completed by 100 well-characterized CU patients together with two anchor instruments, the Chronic Urticaria Quality of life Questionnaire (CU-Q2oL) and the urticaria activity score (UAS), to obtain information on its internal consistency reliability and convergent validity. The Persian version of the UCT was found to have acceptable internal consistency reliability with a Cronbach's alpha coefficient of 0.68. In addition, the results obtained with the Persian UCT correlated with the CU-Q2oL total score (-0.48, p<0.001) and the UAS (-0.404, p< 0.001), suggesting convergent validity. Virtually all patients had poorly controlled CU (UCT<12). A Persian version of the UCT is now available and may help to improve the assessment and monitoring of disease control in Persian-speaking CU patients and to optimize treatment decisions