Action C2: Validation and comparison of the effectiveness of the two Aerobiological Information Systems
Beneficiary responsible for implementation: IFC-CNR
Action Completed
Foreseen start date: second trimester 2015 Actual start date: second trimester 2015
Foreseen end date: May 31st 2017 Actual end date: May 31st 2017
Update:
Action C2 has the purpose of validating and comparing the effectiveness of the two Aerobiological Information Systems. To reach these aims, statistical analyses will be performed on the collected data of the I and II field survey carried out before and after the AIS implementation over the past 12 months.
To assess the real effectiveness of the IIS and PPI, some potential confounders will be taken into account in the statistical analyses: demographic characteristics of the investigated subjects, exposure to risk factors (work exposure, smoking habits, indoor sources exposure..), ambient pollen and chemical pollutants levels in the three countries.
Overall analysis on cross-sectional and longitudinal databases will be carried out. Descriptive analyses will include: frequency distribution and chi-square test for categorical variables; analysis of variance to compare the mean values of continuous variables. Multivariate analyses will be carried out through logistic regression analysis taking into account the independent effects of potential confounders.
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Time series analyses will be performed on the health data and pollens/chemical data to assess the effect of the interaction between ambient pollen and chemical pollutants levels in allergic
symptoms temporal variation.
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Concerning the analyses on pre-existent databases, in Pisa (Italy) the EPAP group will select the investigated subjects using pre-existent databases collected during a twenty-five years cross-sectional repeated survey. These databases contain information on respiratory symptoms/diseases, risk factors, diseases familiarity and results of objective measures like spirometry, blood tests (total IgE values) and skin prick tests. Using these data, additional long-term information will be obtained, permitting a better and deeper retrospective characterization of the investigated subjects. These analyses will be included in the final report as an added value. In Paris (France) and Vienna (Austria) the partner will recruit patients suffering from pollen-related allergies in hospitals. The sample size will be the same as in Pisa.
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Performed activities
The activities carried out were:
1. internal meetings about the procedures to be utilized for data management and statistical analyses;
2. preparation of the Statistical plan I concerning the cross-sectional assessment of health status, risk factors exposure, disease control, quality of life, direct/indirect costs in allergic subjects (Annex 7.2.42 submitted in Mid Term Report);
3. preparation of the Statistical plan II concerning the longitudinal assessment of the usefulness and effectiveness of using IIS and PPI for the improvement of respiratory allergic diseases outcomes (Annex 7.2.43 submitted in Mid Term Report);
related to the interaction between ambient pollen and chemical pollutants levels
(Annex 7.2.44 submitted in Mid Term Report);
5. evaluation of possible differences between participants and refusals through the screening data and assessment of risk factor exposure, disease control, quality of life, drugs consumption, direct/indirect costs and use of health services in allergic subjects derived by the I observational phase (Deliverable C2.1 in Annexes/Deliverables Folder);
6. assessment of risk factor exposure, disease control, quality of life, drugs consumption, direct/indirect costs and use of health services in allergic subjects derived by the II observational phase (Deliverable C2.2, in Annexes/Deliverables Folder));
7. assessment of the usefulness and effectiveness of using IIS and PPI for the improvement of respiratory allergic diseases outcomes (Deliverable C2. in Annexes/Deliverables Folder);
8. assessment of the temporal variation in allergic symptoms, ambient pollen and chemical pollutants levels (Deliverable C2. in Annexes/Deliverables Folder);
It should be noted that the evaluation of possible differences between participants and refusals through the screening data was not expected in the original proposal. In fact the Screening Questionnaire is an additional research tool within Action B2 which has been proposed and accepted by the Coordinators and the beneficiaries, in order to optimize and standardize the sample enrolment in the three countries.
Overall, 644 subjects (214 in group A, 212 in group B, 217 in group C) participated in the I phase and 511 (165 in group A, 170 in group B, 176 in group C) in the II phase. Out of 335 subjects using the tools (group A using IIS and B using PPI), 160 (48%) filled in the Satisfaction Questionnaire after 12 months of weekly access to the IIS/PPI system.
Considering the group B using PPI, a mean number of 22 weekly access to PPI app (via internet or mobile devices) during the implementation period of about 12 months was derived by monitoring results of Action C.1, while 121 resulted to be the different users.
Thus, cross checking the results obtained in the analysis carried out in Action C.1 for the use of the PPI application with the actual usage reported by the patients in the satisfaction questionnaire, an higher number of users resulted having accessed the app but with a lower number of weekly accesses considering the results of Action C.1. This difference could be explained by an unstable and differentiated use of the app depending on the individual health conditions in relation to allergy period.
Indicators of progress
•Number of statistical analysis plans for the cross-sectional assessment of risk factor
exposure, disease control, quality of life, drugs consumption, direct/indirect costs and use of health services in allergic subjects created by Month 13: 1
• Number of statistical analysis plans for the longitudinal assessment of the usefulness and effectiveness of using IIS and PPI for the improvement of respiratory allergic diseases outcomes (level of symptoms, quality of life, drugs consumption, indirect costs, use of health services) created by Month 13: 1
• Number of statistical analysis plans for the temporal variation in allergic symptoms related to the interaction ambient pollen and chemical pollutants levels created by Month 13: 1
• Number of statistical analyses on the data collected in the I phase completed by
Month 21: 1
• Number of statistical analyses on the data collected in the II phase completed by
Month 33: 1
• Number of statistical analyses on the longitudinal data collected completed by
Month 34: 1