Evaluation of impermeable covers for bedding in patients with allergic rhinitis

BACKGROUND: Encasing bedding in impermeable covers reduces exposure to house-dust mites, but the clinical benefit of this intervention as part of mite-avoidance measures for patients with allergic rhinitis is not known. We performed a multicenter, randomized, placebo-controlled trial of one year of use of impermeable bedding covers in the bedrooms of patients with rhinitis who were sensitized to house-dust mites to determine the effects on the signs and symptoms of disease. METHODS: Three participating university medical centers enrolled 279 patients with allergic rhinitis who were randomly assigned to receive impermeable or non-impermeable (control) covers for their mattress, pillow, and duvet or blanket. At the start of the study, all participants received information on general allergen-avoidance measures. The severity of rhinitis was measured on a rhinitis-specific visual-analogue scale and by means of a daily symptom score and nasal allergen provocation testing. We also measured the concentrations of Dermatophagoides pteronyssinus (Der p1) and D. farinae (Der f1) in dust from patients' mattresses, bedroom floors, and living-room floors at base line and after 12 months as a measure of the efficacy of the intervention. RESULTS: A total

Comparison of a generic and a rhinitis-specific quality-of-life (QOL) instrument in patients with house dust mite allergy: Relationship between the SF-36 and rhinitis QOL questionnaire

Background: Generic and disease-specific quality-of-life (QOL) questionnaires are commonly used in subjects with allergic rhinitis (AR). AR, however, is closely associated with other disorders such as bronchial asthma and atopic dermatitis (AD). These co-morbid associations may have an effect on the inter-relation of generic and disease-specific QOL outcomes and the behaviour of this inter-relation in time. Objective: To unravel the inter-relationships between the outcome of a generic instrument (SF-36) and a disease-specific instrument (Rhinitis QOL Questionnaire (RQLQ)). Materials and methods: In the framework of a randomized clinical trial with respect to the efficacy of impermeable bedding covers in house dust mite (HDM) allergy, SF-36 and RQLQ were administered to 224 adults with AR and/or allergic asthma and/or AD at baseline and after 12 months of intervention. Regression analysis and canonical correlation were used to estimate overlap. Results: Overlap between SF-36 and RQLQ domains in terms of explained variance ranged from 6% to 56%. Canonical correlation yielded low coefficients (0.16-0.27). Moreover, both SF-36 and RQLQ s

Recommendations for assessing Patient-Reported Outcomes and Health-Related quality of life in clinical trials on allergy: a GA(2)LEN taskforce position paper

The aim of this Global Allergy and Asthma European Network (GA(2)LEN) consensus report is to provide recommendations for patient-reported outcomes (PROs) evaluation in clinical trials for allergic diseases, which constitute a global health problem in terms of physical, psychological economic and social impact. During the last 40 years, PROs have gained large consideration and use in the scientific community, to gain a better understanding of patients' subjective assessment with respect to elements concerning their health condition. They include all health-related reports coming from the patient, without involvement or interpretation by physician or others. PROs assessment should be performed by validated tools (disease-specific tools when available or generic ones) selected taking into account the aim of the study, the expected intervention effects and the determinant and confounding factors or patient-related factors which could influence PROs. Moreover, each tool should be used exclusively in the patient population following the authors' indications without modification and performing a cross-cultural validation if the tool must be used in a language that differs from the original. The result analysis also suggests that the relevance of PROs results in any interventional study should include a pre-post assessment providing information concerning statistical differences within or among groups, rates of response for the PROs and a minimal important difference for the population. The report underlines the importance of further investigation on some topics, such as the quality assessment of existing PROs tools, the definition of inclusion and exclusion criteria and a more extensive evaluation of the correlation between PROs, besides health-related quality of life, and clinical data

Genome-wide association study of angioedema induced by angiotensin-converting enzyme inhibitor and angiotensin receptor blocker treatment

Angioedema in the mouth or upper airways is a feared adverse reaction to angiotensin-converting enzyme inhibitor (ACEi) and angiotensin receptor blocker (ARB) treatment, which is used for hypertension, heart failure and diabetes complications. This candidate gene and genome-wide association study aimed to identify genetic variants predisposing to angioedema induced by these drugs. The discovery cohort consisted of 173 cases and 4890 controls recruited in Sweden. In the candidate gene analysis, ETV6, BDKRB2, MME, and PRKCQ were nominally associated with angioedema (p < 0.05), but did not pass Bonferroni correction for multiple testing (p < 2.89 × 10−5). In the genome-wide analysis, intronic variants in the calcium-activated potassium channel subunit alpha-1 (KCNMA1) gene on chromosome 10 were significantly associated with angioedema (p < 5 × 10−8). Whilst the top KCNMA1 hit was not significant in the replication cohort (413 cases and 599 ACEi-exposed controls from the US and Northern Europe), a meta-analysis of the replication and discovery cohorts (in total 586 cases and 1944 ACEi-exposed controls) revealed that each variant allele increased the odds of experiencing angioedema 1.62 times (95% confidence interval 1.05–2.50, p = 0.030). Associated KCNMA1 variants are not known to be functional, but are in linkage disequilibrium with variants in transcription factor binding sites active in relevant tissues. In summary, our data suggest that common variation in KCNMA1 is associated with risk of angioedema induced by ACEi or ARB treatment. Future whole exome or genome sequencing studies will show whether rare variants in KCNMA1 or other genes contribute to the risk of ACEi- and ARB-induced angioedema

Randomized double-blind placebo-controlled trial of sublingual immunotherapy in children with house dust mite allergy in primary care: study design and recruitment

Background. For respiratory allergic disorders in children, sublingual immunotherapy has been developed as an alternative to subcutaneous immunotherapy. Sublingual immunotherapy is more convenient, has a good safety profile and might be an attractive option for use in primary care. A randomized double-blind placebo-controlled study was designed to establish the ef

An Urban Neo-Poverty Population-Based Quality of Life and Related Social Characteristics Investigation from Northeast China

OBJECTIVE: To investigate quality of life (QOL) and related characteristics among an urban neo-poverty population in northeast China, and to compare this population with a traditional poverty cohort. DESIGN: The research was a cross-sectional survey executed from June 2005 to October 2007, with a sample of 2940 individuals ages 36 to 55 in three different industrial cities of northeast China. Data were collected on QOL status and sociodemographic characteristics. QOL was assessed using the 36-item Short Form Health Survey (Chinese version). Multiple regression analysis was employed to analyze association between sociodemographic variables and QOL. RESULTS: The scores for QOL in the neo-poverty group were higher than those in the traditional poverty group, but lower than those in the general population. When the neo-poverty population was divided into two subgroups by age, 36-45 years and 46-55 years, the differences in QOL scores were not significant. However, there were significant differences in several dimensions between two subgroups according to unemployment time (<5 years and >5 years). Additionally, stepwise regression analysis indicated that disease burden, including disease and medical expenditures, was a common risk factor for declining QOL in the neo-poverty group. CONCLUSIONS: Despite some limitations, this study provides initial evidence that the QOL of the urban neo-poverty population lies between that of the general population and traditional poverty. QOL of the neo-poverty group approached QOL of the traditional poverty group with increased unemployment years. In addition to decreased income, disease burden is the most important factor influencing QOL status in urban neo-poverty

The use of the computerized version of quality of life and health status questionnaires in a community sample in southern Brazil

CONTEXT AND OBJECTIVE: Computerized data collection is an efficient process and well accepted by patients with different disorders. Although computer-based systems have been used to assess health status and quality of life in various areas of healthcare, there is a lack of studies to investigate the effectiveness of these instruments in Brazil. The aims here were to assess the usability of the Portuguese-language versions of the Personal Health Scale (PHS) and the Multicultural Quality of Life Index (MQLI) in southern Brazil and to determine the correlation between these two questionnaires. DESIGN AND SETTING: This was a cross-sectional community-based survey in which participants completed computerized versions of these two questionnaires. METHODS: In a survey conducted in 16 different locations, 458 volunteers completed both questionnaires. Pearson correlation coefficients were generated between the scores of the two questionnaires. The inclusion criteria allowed all volunteers who were able to understand the questions in both questionnaires to participate in the study. RESULTS: The percentage of proper data collection via the computerized versions of the two questionnaires combined was 97.45%. A significant correlation (P < 0.01) between the PHS and the MQLI was observed. CONCLUSION: The computerized versions of the PHS and MQLI demonstrated efficient data collection patterns during the field survey trials. Health-related issues were significantly correlated with the overall experience of wellbeing and quality of life. The computerized versions of the PHS and MQLI are valid tools for research and clinical use in Brazi