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The terms control and remission and other key terms used in chronic urticaria (CU) such as flare-up, relapse, exacerbation, and recurrence have not been fully defined in the literature. Disease monitoring and treatment goals in clinical practice are not well established. After a qualitative appraisal of available evidence, we aimed to find a consensus definition of control and remission, clarify key terminology, provide guidance on how to monitor the disease, and establish treatment goals in clinical practice. A modified Delphi consensus approach was used. Based on a literature review, a scientific committee provided 137 statements addressing controversial definitions and terms, available patient-reported outcomes (PROs), and recommendations on how to measure therapeutic objectives in CU. The questionnaire was evaluated by 138 expert allergists and dermatologists. A consensus was reached on 105 out of the 137 proposed items (76.6%). The experts agreed that complete control and remission of CU could be defined as the absence of signs or symptoms while on treatment and in the absence of treatment, respectively. Consensus was not reached on the definition of other key terms such as flare-up, exacerbation, and recurrence. The panel agreed that the objective of therapy in CU should be to achieve complete control. PROs that define the degree of control (complete, good, partial, or absence) were established. An algorithm for disease assessment is provided. In conclusion, this work offers consensus definitions and tools that may be useful in the management of patients with CU.

Objective: Human and Organizational Factors (HOF) studies in health technology involve human beings and thus require Institutional Review Board (IRB) approval. Yet HOF studies have specific constraints and methods that may not fit standard regulations and IRB practices. Gaining IRB approval may pose difficulties for HOF researchers. This paper aims to provide a first overview of HOF study challenges to get IRB review by exploring differences and best practices across different countries. Methods: HOF researchers were contacted by email to provide a testimony about their experience with IRB review and approval. Testimonies were thematically analyzed and synthesized to identify and discuss shared themes. Results: Researchers from seven European countries, Argentina, Canada, Australia, and the United States answered the call. Four themes emerged that indicate shared challenges in legislation, IRB inefficiencies and inconsistencies, general regulation and costs, and lack of HOF study knowledge by IRB members. We propose a model for IRB review of HOF studies based on best practices. Conclusion: International criteria are needed that define low and high-risk HOF studies, to allow identification of studies that can undergo an expedited (or exempted) process from those that need full IRB review. Enhancing IRB processes in such a way would be beneficial to the conduct of HOF studies. Greater knowledge and promotion of HOF methods and evidence-based HOF study designs may support the evolving discipline. Based on these insights, training and guidance to IRB members may be developed to support them in ensuring that appropriate ethical issues for HOF studies are considered.

Objective: During its first year, the AWARE study assessed disease activity, patient quality of life (QOL), and treatment patterns in chronic urticaria (CU) refractory to H1-antihistamines (H1-AH) in clinical practice. Methods: We performed an observational, prospective (24 months), international, multicenter study. The inclusion criteria were age _>18 years and H1-AH-refractory CU (>2 months). At each visit, patients completed questionnaires to assess disease burden (Urticaria Control Test [UCT]), disease activity (7 day-Urticaria Activity Score [UAS7]), and QOL (Dermatology Life Quality index [DLQI], Chronic Urticaria Quality of Life Questionnaire [CU-Q2oL], and Angioedema Quality of Life Questionnaire [AE-QoL]). We present data for Spain. Results: The study population comprised 270 evaluable patients (73.3% female, mean [SD] age, 48.9 [14.7] years). At baseline, 89.3% were prescribed a CU treatment. After 1 year, first-and second-line treatments became less frequent and third-line treatments became more frequent. At baseline, 47.0% of patients experienced angioedema; at 1 year, this percentage had fallen to 11.8%. The mean (SD) AE-QoL score decreased from 45.2 (28.7) to 24.0 (25.8). The mean (SD) UCT score decreased from 7.0 (4.5) to 12.1 (4.1). According to UAS7, 38.2% of patients reported absence of wheals and itch in the previous 7 days at 1 year compared with 8.3% at baseline. The mean (SD) DLQI score decreased from 8.0 (7.4) to 2.8 (4.6). At the 1-year visit, the percentage of patients reporting a high or very high impact on QOL fell from 29.9% to 9.6%. Conclusions: H1-AH-refractory CU in Spain is characterized by absence of symptoms and a considerable impact on QOL. Continuous follow-up of CU patients and third-line therapies reduce disease burden and improve patients' QOL.

35th European Photovoltaic Solar Energy Conference and Exhibition; 1034-1039, The aim of this work is to compare angle of incidence (AOI) measurement setups for solar cells between laboratories with such capability. For the first time, we compare relative light transmission measurements among eight laboratories, whose measurement techniques include indoor and outdoor methods. We present the relative transmission measurements on three 156 mm x 156 mm crystalline-Si (c-Si) samples with different surface textures. The measurements are compared using the expanded uncertainties provided by each laboratory. Five of the eight labs showed an agreement better than ±2% to the weighted mean between AOIs from -75° to 70°. At AOIs of ±80° and ±85°, the same five labs showed a worst case deviation to the weighted mean of -3% to 5% and 0% to 18%, respectively. When measurement uncertainty is considered, the results show that measurements at the highest incidence angle of ±85° are problematic, as measurements from four out of the six labs reporting uncertainty were found non-comparable within their stated uncertainties. At 85° AOI a high to low range of up to 75% was observed between all eight laboratories.

Background Adverse events (AEs) epidemiology is the first step to improve practice in the healthcare system. Usually, the preferred method used to estimate the magnitude of the problem is the retrospective cohort study design, with retrospective reviews of the medical records. However this data collection involves a sophisticated sampling plan, and a process of intensive review of sometimes very heavy and complex medical records. Cross-sectional survey is also a valid and feasible methodology to study AEs. Objectives The aim of this study is to compare AEs detection using two different methodologies: crosssectional versus retrospective cohort design. Setting Secondary and tertiary hospitals in five countries: Argentina, Colombia, Costa Rica, Mexico and Peru. Participants The IBEAS Study is a cross-sectional survey with a sample size of 11 379 patients. The retrospective cohort study was obtained from a 10% random sample proportional to hospital size from the entire IBEAS Study population. Methods This study compares the 1-day prevalence of the AEs obtained in the IBEAS Study with the incidence obtained through the retrospective cohort study. Results The prevalence of patients with AEs was 10.47% (95% CI 9.90 to 11.03) (1191/11 379), while the cumulative incidence of the retrospective cohort study was 19.76% (95% CI 17.35% to 22.17%) (215/1088). In both studies the highest risk of suffering AEs was seen in Intensive Care Unit (ICU) patients. Comorbid patients and patients with medical devices showed higher risk. Conclusion The retrospective cohort design, although requires more resources, allows to detect more AEs than the cross-sectional design.

Antihistamine drugs are one of the therapeutic classes most used at world level, at all ages and in multiple situations. Although in general they have a good safety profile, only the more recent drugs (second generation antihistamines) have been studied specifically with regard to the more important safety aspects. Given the variety of antihistamine drugs, they cannot all be considered equivalent in application to various special clinical situations, so that the documented clinical experience must be assessed in each case or, in the absence of such, the particular pharmacological characteristics of each molecule for the purpose of recommendation in these special situations. In general, there are few clinical studies published for groups of patients with kidney or liver failure, with concomitant multiple pathologies (such as cardiac pathology), in extremes of age (paediatrics or geriatrics) and in natural stages such as pregnancy or lactation, but these are normal situations and it is more and more frequent (among the elderly) for antihistamine drugs to be recommended. This review sets out the more relevant details compiled on the use of antihistamines in these special situations.

Recombinant and purified allergens are currently available for determining specific IgE targeted to different allergenic components. In this way it is possible to diagnose the sensitization profile of each individual patient. The microarray technique makes it possible to determine specific IgE against multiple allergens simultaneously in one same patient, with a minimum amount of serum, and even allows the determination of IgG and IgM against the same allergens in one same serum sample. Microarray procedures are being developed not only for the determination of antibodies but also for cell activation tests. In addition, microarray technology will help explain cross-reactions, and will facilitate the evaluation of subjects in which skin tests cannot be performed. These techniques will allow a great step forward in the development of immunotherapy specifically targeted to the sensitizations found in each individual patient, yielding especially hypoallergenic forms of great immunogenic capacity, and thus improving the safety and efficacy of immunotherapy. Lastly, microarrays will improve our understanding of the physiopathology of allergic diseases.

The aim of this study was to develop a Spanish version of the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) and to test its acceptability, reliability, validity, and sensitivity to change.Forward and back translation by bilingual translators followed by pilot testing in patients with urticaria was used to adapt the questionnaire. The Spanish version of the CU-Q2oL was self-administered alongside the Skindex-29 in an observational, longitudinal, multicenter study. Feasibility was assessed by analyzing missing responses and ceiling and floor effects. Reliability was tested by examining internal consistency (Cronbach alpha). Construct validity was analyzed by examining convergent and discriminant validity with the Skindex-29 and by evaluating the ability of the CU-Q2oL to discriminate between patients according to a clinical classification of severity. Sensitivity to change was analyzed in a subgroup of patients who completed a second visit 4 weeks after baseline.A total of 695 patients were included in the analysis. Mean (SD) age was 42.4 (15.0) years and 62.1% of the sample was female. All of the items on the CU-Q2oL were answered by 91.9% of the sample. Over 15% of patients scored at the floor (best possible health) on 5 of the 6 dimensions. Cronbach alpha coefficients were0.80 for all dimensions of the CU-Q2oL, and 0.86 for the overall score. Construct validity was supported by correlations between the CU-Q2oL and the Skindex-29, which generally fulfilled hypotheses, and by the questionnaire's ability to discriminate between groups with different severities of urticaria.The questionnaire was sensitive to change, with an effect size of 1.0 for the overall score in patients reporting an improvement on the health transition scale.The Spanish version of the CU-Q2oL has shown satisfactory reliability, validity, and sensitivity to change. It is suitable for use as an outcome measure for chronic urticaria patients in clinical and research settings.