Comparison of six disease severity scores for allergic rhinitis against pollen counts a prospective analysis at population and individual level.

BACKGROUND: Many different symptom (medication) scores are nowadays used as measures of allergic rhinoconjunctivitis severity in individual patients and in clinical trials. Their differences contribute to the heterogeneity of the primary end-point in meta-analyses, so that calls for symptom (medication) score harmonization have been launched. OBJECTIVE: To prospectively compare six different severity scores for allergic rhinitis (AR) against pollen counts at both population and individual levels. METHODS: Two groups of children with seasonal AR and grass pollen sensitization were recruited in Ascoli, Italy (n = 76) and Berlin, Germany (n = 29). Symptoms and drug intake were monitored daily for 40 and 30 days of the grass pollen season in 2011 (Ascoli) and 2013 (Berlin), respectively, through an Internet-based platform (AllergyMonitor(™) , TPS Production srl, Rome, Italy). From the gathered data, the informatics platform automatically generated one symptom score (RTSS) and five symptom-medication scores (RC-ACS(©) , ACS, RTSS[LOCF], RTSS[WC] and AdSS). Values were then statistically normalized for reciprocal comparison and matched against the daily variations of local grass pollen counts (Spearman's rank correlation). RESULTS: The grass pollen counts were higher in Ascoli than in Berlin (peak values 194 vs. 59 grains/m(3) ). At population level, the trajectories of the normalized average values of the six scores differed only slightly in both studies and correlated well with the pollen counts (ranges r(2) : 0.38-0.50 in Ascoli, 0.41-0.56 in Berlin). By contrast, in individual patients, trajectories of different scores were often quite heterogeneous. The RTSS[WC] had a very low discriminatory power and generated in many patients long, flat horizontal segments. CONCLUSIONS: Disease severity scores for seasonal AR, as evaluated via an Internet-based platform, tend to provide similar results at population level but can often produce heterogeneous slopes in individual patients. The choice of the disease severity score might have only a low impact on the outcome of a very large clinical trial, but it may be crucial in the management of individual patients.

Study protocol of a prospective, interventional non-randomised trial investigating the impact of asthma education on specific disease understanding, health literacy and therapy outcome in childhood.

INTRODUCTION: Childhood asthma is a highly prevalent chronic disease. A failure to implement patient education programmes may result in increased morbidity, despite the availability of distinct diagnostic and therapeutic approaches. Patients with lower socioeconomic status (SES) tend to have a higher asthma prevalence. Moreover, the progression of asthma is significantly influenced by factors such as health literacy and the children's specific knowledge about the condition. With this trial, the primary objective is to evaluate whether asthma education enhances specific disease understanding in children with asthma (primary outcome). Secondary objectives include evaluating training effects on health literacy, retention rates of information, 'Children Asthma Control Test' (C-ACT) score, frequency of emergency room and physician visits (secondary outcomes) and whether SES influences training effects. METHODS AND ANALYSIS: To address the research objectives, this study comprises two projects. The first subproject will investigate the influence of asthma training on the development of disease understanding and health literacy. The second subproject will analyse the influence of SES on the outcome of children participating in asthma training. This research is designed as a comparative, non-randomised study involving two paediatric groups between the ages of ≥7 and < 14 years. After being diagnosed with asthma, the intervention group undergoes standardised psychoeducational asthma training at a certified centre associated with paediatricians in private practice in Germany, following the recommendations of the 'Arbeitsgruppe Asthmaschulung im Kindes- und Jugendalter e.V.', a national association aiming to establish uniform and guideline-based standards for patient education in children and adolescents. The comparison group receives a significantly shorter period of education and instruction on the usage of asthma medication at outpatient clinics. Data will be collected from patients and their parents at three specific survey time points, based on standardised tools.To describe mean differences between the intervention and control group over time (subproject 1), a repeated-measures analysis of variance (ANOVA) will be conducted. In subproject 2, multivariate linear regression analysis will be used to analyse the variables determining the changes in specific disease understanding and health literacy, including SES. The sample size calculation is based on a mixed ANOVA model with two groups and two measurements resulting in a total of 126 participants. ETHICS AND DISSEMINATION: All protocols and a positive ethics approval were obtained from the Witten/Herdecke University, Germany (S-159, 2023; application submission: 24 June 2023, final vote: 10 July 2023). Furthermore, the study was registered at the German Clinical Trials Register (DRKS), DRKS00032423. The application submission was on 3 August 2023, and the final approval was on 4 August 2023. The results will be disseminated among experts and participants and will be published in peer-reviewed, international journal with open access. TRIAL REGISTRATION NUMBER: DRKS00032423.