METHODS:
PATIENTS:
SANI is a web-based observatory collecting demographic, clinical,
functional, inflammatory biomarkers data of patients with severe asthma
according to European Respiratory Society (ERS)/American Thoracic
Society (ATS) classification 11 and aged
> 12 years, recruited by accredited centers homogeneously
spread out the national territory 12,13. All centers,
have been contacted and inquired to report confirmed (i.e. patients with
positive test result for the virus SARS-CoV-2 from analysis of
nasopharyngeal or oropharyngeal swab specimens) or highly suspect cases
of COVID-19 (i.e. patients with symptoms, laboratory findings and lung
imaging typical of COVID-19 but without access to nasopharyngeal or
oropharyngeal swab specimens because of clinical
contingencies/emergency) among their cohorts of severe asthma.
Demographic and clinical data of the entire population of severe
asthmatics enrolled in the study and all reported cases of confirmed or
suspect cases of COVID-19, have been obtained from the registry platform
and collected from the additional Center (Azienda Ospedaliero
Univeristaria di Ferrara, Ferrara, Italy). Additional data about
COVID-19 symptoms, treatment and clinical course have been collected for
all cases reported.
GENERAL INFORMATION ON COVID-19 IN ITALY:
Open access data about the number of confirmed cases of SARS-CoV-2
infected subjects in the Italian general population have been collected
from the Civil Protection Department of the Italian Government website1, and used to draw a thematic map representing the
number of cases divided by administrative regions.
ETHICAL ISSUES:
The observatory was carried out according to the declarations of
Helsinki and Oviedo. The SANI registry was set up according to the 3rd
Edition Recommendation on registries for evaluating patient outcomes
published by the Effective Health Care Program of the Agency for
Healthcare Research and Quality
(https://effectivehealthcare.ahrq.gov/topics/registries-guide-3rd-edition/research/).
The protocol was performed according to the principles and procedures of
the Good Clinical Practice (ICH Harmonized Tripartite Guidelines for
Good Clinical Practice 1996; Directive 91/507. EEC, The Rules Governing
Medical Products in the European Community) and according to the Italian
laws (D.L.vo n.211 del 24 Giugno 2003;D.L.n.200 del 6 Novembre 2007; MD
del 21 Dicembre 2007).
STATISTICAL ANALYSIS:
Statistical analysis was performed using SPSS 21.0 software (SPSS,
Chicago, IL, USA). The Kolmogorov-Smirnov test was used to evaluate the
normality of distribution of each continuous variable, and depending on
the result of this test, the Student t-test or Mann-Whitney test was
used to compare variables. Categorical variables were compared with the
Fisher exact test. A p-value < 0.05 was considered
statistically significant.