AIS LIFE 

Beneficiary responsible for implementation: IFC-CNR

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Completed Action.

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Foreseen start date: June 1st 2014                              Actual start date: June 1st 2014

Foreseen end date: May 31st 2017                               Actual end date: May 31st 2017

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Action B1 has the purpose of assessing and validating the effectiveness of the two implemented Aerobiological Information Systems (IIS and PPI) through field surveys on general  population  samples  affected  by  allergies.  The  questionnaires  and  daily  diary developed in action B2 are used in the field surveys included in action B1.

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Update:

The Pisa's sample selection from pre-existent databases of the subjects to be enrolled has been finalized (see Annex 7.2.3). An online log including all the selected subjects' nominatives, addresses and phone numbers has been realized. The randomization of the selected subjects in the three foreseen groups (A, B and C) has been carried out for the 3 partners.

The realization of a centralized platform hosted by AIS web site to be utilized for enrollment, data collection, education, monitoring has been proposed to partners/coordinator. This system could be used by each partner involved in the field survey but also by coordinator for having a continuous update of the field survey.

This way, databases including all the data of screening phase and the 2 observational phases can be automatically obtained. This modality is advisable since it would allow to store more reliable data; to save paper and to increase number of AIS web accesses if the Qs are self- filled in online; to have a suitable system for short term and long term project monitoring. A budget for the implementation and management of this online platform has been provided by Techno-science Unit, IFC, CNR to be compared and discussed in respect to other estimates. Remedial Measure: in order to make up for lateness we will start enrolling subjects by telephone Screening Questionnaire.

Collaboration with UNIPI, the beneficiary responsible of action A.1 aimed to set up the Integrated Information System (IIS), in order to organize the chemical data acquisition especially  concerning  UFP  (ultrafine  particulate)  and  medical  recommendations  (Annex

7.2.11)

 

Preparation  and  editing  of  the  documents  to  be  submitted  to  the  Azienda  Ospedaliero

Universitaria Pisana (AOUP) Ethical Committee to request the study approval. Documents were sent to AOUP Ethical Committee secretary on 23/01/2015 for a preliminary revision. The Ethics Committee of the University Hospital of Pisa approved the study on 26/02/2015. With regard to Deliverable B1.1 (see Annex 7.2.4), the field survey protocol (Italian and English versions), concerning the field study to assess efficacy of PPI and IIS systems, was prepared as extended and shortened versions (see Annex 7.2.5, 7.2.6). Initially, the field survey protocol was prepared by CNR as an extended version dealing with the scientific and operating issues of the project. As requested by AIS partners, a shortened version was also prepared to quickly support fieldworkers activities.

Educational material has been completed in Italian and English version (Deliverable B1.1, see Annex 7.2.7, 7.2.8). Further, a shortened version of educational material, suitable for the general public, has been realized, both as an Italian and English version (see Annex 7.2.9,

7.2.10).

Check  and  revision  of  the  functionality/contents  of  two  smartphone  pollen  application versions prepared by MUW: the first version for PPI (App 1) and the second version to get information about pollen load for the next three days in certain area (App 2).

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Performed activities:

 

 

·    The activities carried out were:

 

 

·    1. internal meetings about the coordination and the field survey organization of the action B1;

 

 

·    2. preparation of a predefined list of randomization through an SPSS routine.

The list contains 250 combinations between the consecutive number of enrolment and the study group for assigning the enrolled patients in the 3 study groups. Once inclusion criteria were ascertained through the Screening questionnaire, the list allowed the subject to be promptly  assigned to one of the groups;

 

 

·    3. selection and enrolment  of  a general population  sample suffering from pollen allergy (symptoms/diagnosis of allergic rhinitis or allergic asthma) living

 

in Pisa (Italy), Paris (France) and Wien (Austria) from pre-existing databases, medical offices, hospitals and website;

 

 

·    4. preparation  of  the extended and shortened versions of  the field  survey protocol  (Italian and English  versions) aimed to  standardize the  operating modalities of the field survey thus guaranteeing high-quality and comparable results (Deliverable  B1.1, see Annex 7.2.5, 7.2.6 of Mid Term Report);

 

 

·    5. preparation of the educational toolkit  to be utilized within the field survey (Italian and English  versions) about use and conditions of access to the AIS (groups  A,  B), promotion   of  life  styles and  medical  recommendations  to prevent exacerbations of respiratory allergic diseases (all the groups). Further, a shortened version of the educational material, suitable for the distribution to the  general public,  has been realized, as an Italian  and English  brochure (Deliverable B1.1);

 

 

·    6. execution of the I observational phase (T0) through the completion of the Health Questionnaire about the health status and quality of life associated with allergic diseases in the previous 12 months (all the groups);

 

 

·    7. execution of the II observational phase (T12) through the completion of the Health Questionnaire about the health status and quality of life associated with allergic diseases in the interval between the two surveys (all the groups) and of the Satisfaction Questionnaire about usefulness/use of the IIS and PPI (groups A, B);

 

 

·    8. weekly completion  of the IIS to be used in Paris, Pisa, Vienna adding the medical recommendations in relation to the forecasted pollens and pollutants concentrations;

 

 

·    9. testing  in  Pisa of  the  simplified  protocol  for  ultrafine  particulate  (UFP)

assessments and execution of the UFP spot monitoring in France (Paris: 20 - 26

January and 2 - 8 February 2016; Lyon: 15 February - 5 March 2016; Brussieu:

23 - 27 May  and 30 May - 3 June 2016), Pisa (9 - 22 November 2015 and 13 -

24 June 2016) and Vienna (30 November - 13 December 2015 and 4 - 17 July

2016).

 

 

·    Overall 644 subjects participated in the I observational phase;  214 subjects have been enrolled in group A, 212 subjects have been enrolled in group B and 218 in group C. Given that the Original Study Proposal (LIFE13- ENV_IT_001107, page 45, Action B1) states that "177 allergic subjects in each group  (a total  of 531 subjects) are expected to  be enrolled"  to  detect the

 

investigated effects with a sufficient statistical power, the final number of enrolled  subjects is  able  to  guarantee  reliability  of  the  results obtained through the statistical analyses.

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Indicators of progress

• Number of subjects enrolled and interviewed for each group (A, B, C) in action B1:

214 in group A, 212 in group B and 218 in group C

• Number of health questionnaires collected in the I phase and inserted into the

centralised database: 644

• Number of weekly access of groups A-B to the IIS and PPI (via internet or mobile devices) during a period of 12 months for each subject: 220

• Number of telephone interviews carried out in the II observational phase: 413

• Number of health questionnaires collected in the II phase and inserted into the

centralised database: 511

• Number of satisfaction questionnaires collected in the II phase and inserted into the centralised database: 160