LIFE12 ENV/IT/000834 MIDTERM Report Covering the project ...

(Projects submitting final reports after 1 January 2014 must use this format.)

LIFE12 ENV/IT/000834

MIDTERM Report

Covering the project activities from 01/07/2013 to 31/01/2015

Reporting Date

25/03/2015

LIFE MED HISS Mediterranean Health Interview Survey Study

Project Data

Project location Turin (Italy)

Project start date: 01/07/2013

Project end date: 30/06/2016

Total budget € 1,598,283 Euro

EC contribution: € 790,788 Euro

(%) of eligible costs 50.00%

Beneficiary Data

Name Beneficiary AGENZIA REGIONALE PER LA PROTEZIONE

AMBIENTALE DEL PIEMONTE

Contact person Mr. Ennio Cadum

Postal address Via Sabaudia 164, 10095 Grugliasco (TO), Italy

Telephone +39 011 19680760

Fax: +39 011 19681591

E-mail [email protected];

[email protected];

Project Website www.medhiss.eu

LIFE MED HISS MID TERM Report- from 01/07/2013 to 31/01/2015 2/60

1. List of contents 1. List of contents ................................................................................................................... 2

List of abbreviations................................................................................................................... 3

2. Executive Summary ........................................................................................................... 4

3. Introduction ...................................................................................................................... 12

4. Administrative part........................................................................................................... 14

4.1 Description of the management system ......................................................................... 14

4.2 Evaluation of the management system........................................................................... 18

5. Technical part ................................................................................................................... 20

5.1. Technical progress, by task ........................................................................................... 21

5.2 Dissemination actions .................................................................................................... 35

5.3 Evaluation of Project Implementation............................................................................ 41

5.4 Analysis of long-term benefits ....................................................................................... 47

6. Comments on the financial report .................................................................................... 51

6.1. Summary of Costs Incurred........................................................................................... 51

6.2. Accounting system ........................................................................................................ 53

6.3. Partnership arrangements (if relevant) .......................................................................... 55

6.4. Auditor's report/declaration........................................................................................... 55

7. Annexes................................................................................................................................ 58

8. Financial report and annexes................................................................................................ 60


List of abbreviations

CB Coordinating Beneficiary

AB Associated Beneficiary

CTM Chemical Transport Model

ICD International Classification of Diseases

SC Steering Committee

NHIS National Health Interview Survey

ARPAP Agenzia Regionale per la Protezione dell’Ambiente del Piemonte

ENEA Italian National Agency for New Technologies, Energy and Sustainable

Economic Development

CREAL Fundació Centre de Recerca en Epidemiologia Ambiental

UPMC Université Pierre et Marie Curie

INSERM Institut National de la Santé et de la Recherche Médicale

NIJZ National Institute of Public Health Slovenia

SEPI SCaDU Epidemiology ASL TO3

MINNI National Integrated Modelling system for International Negotiation on

atmospheric pollution


2. Executive Summary

2.1 Project objectives

MED HISS is a LIFE project involving four European countries (Italy, France, Slovenia and

Spain). MED HISS aims to set up a cheap European surveillance system of air pollution long

term effects, contributing to the scientific knowledge needed for the development of European

environmental policy and legislation. The long term health effect surveillance system

proposed is based mainly on National Health Interview Survey (NHIS), already available.

These surveys are representative of each national population and covering both urban and

rural areas.

The original idea of the project was to follow-up the surveys (for the four countries involved

in the project) by a linkage with mortality and, wherever possible, morbidity data registers, to

assign to each subject the individual health status. It is possible to attribute to each subject a

defined level of air pollution exposure at municipality level, in terms of annual level of

particulate PM10, PM2.5 and gases NO2, O3 using data derived from available national

dispersion models.

These data sets (concerning the cohorts) contain information that allows a full control of

confounding factors at individual level: it’s possible, in other words, to control for other

factors that are linked to the same health effects (either if they are not the environmental risk

factors of interest), for example controlling for smoking habits.

In this way, air pollution long term effects can be evaluated in a proper way for a wide range

of diseases using individual data and applying statistical methods to analyze cohorts in

epidemiology.

Restrictive privacy policies, arisen in Spain and Slovenia after the project’s start didn’t allow

the linkage between individual data (the Spanish and Slovenian surveys) and mortality and

morbidity data registers. Therefore, it was necessary to set up an alternative study design,

mentioned in the proposal as a possible “mitigation measure” based on aggregated data: the

ecological approach.

If this strategy will provide results comparable with individual approach, it will offer the

opportunity to use an alternative surveillance system, permitting to overcome privacy

policies barriers. Last but not least, it offers the opportunity to test an even cheaper

surveillance system.

The ecological approach is based on the use of available data (mortality/morbidity and

potential confounders) not at individual level but at aggregated level (called area). The air

pollution exposure is then assigned at the desired level, municipality or area, following the

same scheme planned for the individual approach. In fact, the available dispersion models

(currently used for air pollution forecasting and hind casting) provide data on a regularly

spaced grid. A specific focus of the project is to examine in depth the exposure assessment:

one of the tasks is to improve the models at the ground level, integrating them with

monitoring stations’ data and, after that, assign exposure to each municipality on the basis of

the built-up area, to assign exposure where people really live. The improvement derived on

this issue will be relevant for both approaches, individual and ecological.


To guarantee the comparison between the two approaches, the project coordinator

(ARPAP- Italy) will carry on the individual study on the whole national territory and both

approaches (individual and ecological) on the Piedmont region.

By now, preliminary results performed on the Italian cohort (i.e. using individual data)

confirm the results obtained by other published cohorts results, specifically recruited for air

pollution health effects studies. This is an encouraging suggestion for the potential

effectiveness of MED HISS surveillance system, and for the hypothesis to build a cheap

system using NHIS data available for each EU country, provided that the data could be linked

with individual data on mortality and morbidity.

The final results of both studies, individual and ecological, will be available at the end of year

2015.

Despite the privacy problems encountered, MED HISS project is still relevant and aims at

contributing to the updating and the development of European Union environmental policy

and legislation, in term of European usable measure of adverse chronic air pollution health

effects. When the directive 2008/50/CE will be updated, it could take into account results

from MED HISS project.

An Health Impact Assessment (HIA) procedure, based on the estimates obtained, will be

performed in all project countries to calculate the attributable cases.

The current understanding of the association between air pollution long-term exposure and

adverse health effect is presently mainly based on cohort studies coming from USA, Canada,

Japan, China. Few studies with restrictions on age of cohort recruited, on kind of pollutant

studied, and with a poor geographical variability have been conducted so far in Europe.

ESCAPE project, even if based mainly on urban cohorts and which results have been

published after MED HISS project’s start, allows a comparison with MED HISS final outputs.

The European HIA currently obtained using risks from American cohorts could give biased

results: MED HISS is a demonstration project with the aim to guarantee to the EU a source of

information for HIA based on direct measurements.

The aim is to assess the feasibility of the adopted approach to spread it in other European

countries, in order to create a European cohort database of individual characteristic and air

pollution data exposure with a specific attention to the exposure assessment and to the

standardization of confounding factors.

An efficient management system have been set up to help participants to reach the planned

objectives: 1. the organization of periodic contacts with ARPAP staff; 2 the planning of

interventions on administrative and financial aspects during technical meetings; 3 the constant

use of the private area of the Website (Platform) to share and check documents, have

contributed to finalize a firm management and to achieve the financial deadlines.

The Steering Committee, with representative of all partners and external experts has a

transversal role with decision power and oversaw project implementation. The participation of

the two external experts, as inferable from the meetings minutes, is providing a good

scientific debate.

The stakeholders communication strategy should guarantee a strong relationship with

European actors in order to support European policy frameworks and strategies development.


2.2 Key deliverables and outputs

In Table 1 we list all the deliverables and outputs already produced or in progress, but with a

deadline foreseen in the next 9 months.

The MED HISS project is going on without serious obstacles that would affect the reaching of

the above described objectives of the project by its deadline. There is a delay in the

acquisition of Slovenian data dispersion modelling, due to the validation procedure that is

much more time consuming than foreseen and to the legislative and administrative national

restrictions for health data access, a slight delay in the acquisition of the updated Italian

outcomes, due to administrative procedure, and of the exposure and health French data

acquisition, for the changed assignation of the French partner (for this we are asking an

amendment to add INSERM as a project’s partner).

Even if there is a delay in data processing (for both environmental and health parts), a subset

of them have been already acquired and procedures have been set-up, permitting to develop

and test the statistical strategy to be adopted in the final analyses. Statistical analyses are

ongoing and the environmental and health data-processing will be ended, in order to respect

the deadlines concerning the main output of the project (statistical analyses, map and HIA).

Using this scheme, preliminary analyses on Italian cohort have been already done and

presented at the Mid Term workshop in Barcelona (October 2014). These analyses have

been done for each subject using the exposure to PM2.5 modelled for year 2005 at

municipality level, and 8 years of follow-up on mortality and hospitalization. Statistical

methodology used was Cox model, using a set of confounders chosen for a direct comparison

with literature.

All health and environmental data will be in the final form by the end of June 2015. The

meeting already scheduled in Lubiana (on July 2015) represents now a Milestone

corresponding to the end of data collection and processing. In this meeting also advanced

forms of statistical protocol and of HIA protocol will be discussed and finalised.

Key outputs of the project are the following:

- acquisition of modelling exposure data, testing a methodology for the integration of data

from monitoring stations and an exposure assessment on the built-up area;

- individual study of the cohorts, Italian and French, recruited for institutional purpose and

followed for a medium-long period;

- ecological study as a test for an surveillance system, even cheaper than the individual study;

- map to describe and disseminate MED HISS results to stakeholders, in order to extend the

pilot study to other EU countries;

- an efficient management system based mainly on sharing common procedures for reporting

and a defined timing;

- implementation of the Private area of the website (Platform) to collect documents useful for

a good performance of the management-reporting system;

- a stakeholders map will describe the network of scientific and political key actors, essential

for the implementation of the pilot aspects of the project;


- website published, implemented in march 2015 and currently updated;

- notice board in English, Italian, French and Spanish language have been produced until

today.


Name of the

deliverable

Output

produced

Associat

ed

action Due date Status

Annex

The meetings

foreseen for the

project:

KO meeting

Turin, 2013

B2 meeting Paris,

2014

B1 meeting

Bologna, 2014

B3 meeting

Barcelona, 2014

B4 meeting

Lubiana, July

2015

D3 meeting

Barcelona,

December 2015

Minutes B1/B2/

B3/B4/

D3

Completed on

time. For kick-off

meeting there

were 3 months of

delay.

Annex 25 -

Minutes of

the

meetings

(Minutes of

kick-off,

first action

meetings,

MID

TERM

workshop)

Air pollution

mapping protocol Protocol B 1 31/12/2013 Completed on time. Annex A-

Air

pollution

mapping

protocol

Air pollution data

set Datasets B 1 31/03/2015 Completed for

Spain and Italy by

30/06/2014.

To be completed

for Slovenia and

France.

Exposure

assessment study Report on

results

obtained

B 1 31/03/2015 Completed on

time

Annex 6–

Exposure

assessment

study

The map of air

pollution data at

municipality scale

for each country

and each pollutant

Map at

municipality

level

B 1 31/12/2014 Done for Spain.

Ongoing for Italy,

Slovenia and

France . New

deadline:

30/06/2015

First results

at the end

of Annex 6-

Exposure

Assessment

study Health data

collection protocol Protocol B2 Required in

letter

ENV/E4/FD/

SEB/ps

Completed on time. Annex B –

Survey and

health data

protocol

Report on health

data available and

health data

endpoints

Report B2 30/06/2014 Completed on

time for Italy,

postponed for

France after the

Annex 9-

Individual

approach

data


amendment available

and health

endpoints

Annex 10-

Ecological

approach

health

endpoints

Final report on

population data

after linkage

procedures

Report B 2 31/12/2014 Intermediate

follow up

completed for

Italy.

Ongoing for

French partner.

Deadline

postponed to

30/06/2015

Feasibility study

for a common air

quality map for

epidemiological

purposes

Report B3 30/09/2015 Ongoing.

Confirmed.

Report of

descriptive

statistics of

variables that will

be used in the

analysis

Report B 3 30/09/2015 Not due.

Confirmed.

Annex 8–

Preliminary

results

PM2.5 year

2005 Italy

Report of the

statistical

modelling that will

be used in the

analysis

Protocol B4 30/09/2015 Ongoing.

Confirmed.

Annex 7-

Statistical

protocol

(draft)

Reports on

morbidity and

mortality analysis

Reports B5/B6 31/10/2015

–

15/12/2015

Not due.

Confirmed.

Two draft papers

for scientific

journals

Draft papers B5/B6 31/12/2015 Not due.

Confirmed.

Protocol for the

HIA procedures Protocol B7 30/06/2015 Ongoing.

Confirmed.

Annex 11 –

List useful

for

literature

review

Annex 12 -

HIA

protocol

(draft)

Preliminary

assessments of the

impact on overall

and country-

Report B7 31/12/2015 Not due.

Confirmed.


specific mortality

and morbidity

Report on

epidemiological

evidences to

support EU policy

on environment

Report C1 Added in

the

Inception

Report

Completed on

time.

Annex F-

Epidemiolo

gical

evidences

to support

EU policy

Presentation of

epidemiological

air pollution map

to European Union

and local

stakeholders

Map C1 30/09/2015 Postponed to

31/12/2015

Annual conference

of the

International

Society for

Environmental

Epidemiology

communication

(oral or poster)-

ISEE

Abstracts D1 20/08/2015 Ongoing.

Confirmed.

Annex 20 –

Abstracts

ISEE 2015

Development of

website and

maintenance of it

Website

second

revision,

usage report,

documents

uploaded

D2 31/03/2015 Completed on

time the

development of

website. It is

currently used and

updated

Minutes of the SC

meetings/teleconfe

rences/videoconfer

ences

Minutes E1 Completed on

time those

foreseen until now

Annex 27 –

Minutes of

the Steering

Committee

meetings

Monitoring

protocol of the

project

Protocol E2 Required in

letter

ENV/E4/FD/

SEB/ps

Completed on

time.

Annex C -

Monitoring

protocol of

the project

Monitoring reports

of the project

progress

Reports E2 Required in

letter

ENV/E4/FD/

SEB/ps

Completed on

time (those due

until March 2015)

Annex 3 –

Monitoring

reports

Videoconferences

to monitor the

status of the

project every 6

months

Minutes E2 Completed on

time those

foreseen until now

Annex 3 –

Monitoring

reports

Progress report

(one at the end of

2014 and one at

the end of 2015)

Report E2 Completed on

time progress

report 2014

Annex 3 –

Monitoring

reports


2.3 Summary of the report

The present report describes the state of the art of MED HISS project after 19 months (out of

36).

The report is structured in: Summary, Introduction, Administrative part, Technical part -

containing the Technical progress per task, the Dissemination actions, the Evaluation of

project implementation and the Analysis of long-term benefits - and finally the Comment on

the Financial report.

All of the technical actions (Action B1 – B7) are still in progress.

Elaboration of environmental data (Action B.1) is in the closing stage, with a small delay due

to the update of the models and to the inclusion of external experts’ suggestions for all the

countries involved.

The Action B.2 is ongoing. After the approval of the protocol, the health necessary data

collection is in the progress for all countries, including those with legislative impediment on

privacy policies that will not be able to enrol individual data and for French partner waiting

the amendment.

Individual Italian data (used to obtain preliminary results) will be improved adding more

years of exposure and extending the follow up period. Major evaluation about the need of

standardized variables for the confounding control and the statistical methodologies are

ongoing (Action B.3 and B.4). The objective is the comparison among European surveys.

These aspects are under discussion, and will be finalized in a protocol scheduled for

September 2015 and discussed during Action B4 meeting (Action B.4) on July. The B4

protocol will deal with both studies, ecological and individual.

Also the protocol concerning the Health Impact Assessment is under discussion (Action B.7).

Results on mortality and morbidity endpoints (Action B.5 and B.6) will be available by the

end of 2015.

The administrative part reports in detail the successful management process adopted, the

coordination scheme and the organization of the project team. The management system is also

evaluated according to the problems encountered and the solutions adopted thanks to a joint

effort from the partnership. The financial part is a comment on the financial report, including

an overview of costs incurred, information on the accounting system, and allocation of costs

per action. As a general comment, we are in line with what was scheduled in the original

proposal, as breakdown of budget posts.

The current report covers about an half of the entire project (from 01/07/2013 to 31/01/2015,

19 out of 36 months) and report a cost of € 662.698, about the 40% of the total cost of the

project.

Dissemination activity strictly related to stakeholders strategy represents the engine to exploit

the potentiality of our pilot project.


3. Introduction

Environmental problem/issue addressed

The European Commission is engaged since many years in evaluating air pollution health

impact in Europe and promoting effective measures for its reduction.

Many studies have demonstrated chronic health effects of air pollution. A better knowledge of

long term effects of fine and coarse particles is mandatory in order to contribute to the policy

on the environment and health (the Environment and Health Action Plan) integrating and

supporting EC legislation in this field, to plan mitigation actions and to implement efficient

practical measures.

In this scenario MED HISS addresses several favoured indicative actions:

- Integration and harmonization among the environmental data and health information;

- Development of best practice examples about using environmental monitoring data to

protect human health.

Outline the hypothesis to be demonstrated / verified by the project

The problems targeted by the MED HISS project are to estimate long-term health effects of

air pollution in Mediterranean area exposed to high air pollution levels, providing new

evidence to support EU legislation and implementing an epidemiological cheaper surveillance

system to monitor these effects over time. The Health Impact Assessment, HIA, is the final

output of the project and the results will be used for communication and dissemination to non

technical targets (policy makers and stakeholders).

Technical and methodological solution

MED HISS surveillance system is based on linking exposure information, mortality and

hospital admissions registries and National Health Interview Surveys (if individual linkage is

not available and alternative/comparable approach will be implemented using as confounding

variables characteristics from aggregated area).

The priority of MED HISS is human monitoring, data linkage with environmental chemicals

(PM10, PM2.5, NO2, O3) and health status of the population.

To reach this goal, in MED HISS project data are acquired, beside health data considering a

cohort representative of the whole population (both urban and rural areas), air pollution data

from national deterministic dispersion models in Catalonia (CALIOPE), France (CHIMERE),

Italy (MINNI) and Slovenia (ARSO) that are able to give an estimate on a regularly spaced

grid, even in places where fixed monitoring stations are not available.

In addition to measure adverse health risks of air pollution HIA will be used to more

extensive communication.

Expected results and environmental benefits

Main expected result is the demonstration of the feasibility of the development of a cheap

surveillance system in Europe. By the development of recommendations and best practice

examples about using available health and environmental data, MED HISS aim to augment

the usefulness of the epidemiologic methods to update EU about health risks related to air

pollution.

First of all we will have the comparison between the risks estimated by MED HISS with the

published one; secondary, we will estimate the attributable cases; third, the “lesson learned”

will be shared with all the stakeholders.


In addition to the above mentioned results, the project could have a direct impact on the

European initiatives and discussion on air quality, health effects, and the need to air quality

management. To achieve that, we are aware of the necessity of a large involvement of

stakeholders at international, national and local level. In that way we will improve their

sensitivity to the target problem, and stirred the attention of media (international journals,

national, local and online journals) towards the results produced by MED HISS.

Expected longer term results

The outcomes of the project are believed to have the following impacts:

1. Future contribution to implementation, updating and development of European Union

environmental policy and legislation on air quality: the results of the project could

demonstrate that actual experimented environmental level have health consequences. A future

environmental-health policy could have direct impact on air; as well as indirect impacts on

various economic sectors, including car industry for the production of low polluting vehicles,

producers of heating systems employing less fossil fuels and biomasses, heavy industry with

control of emissions and targeted energy use.

2. Integration of the environment into other policies: the MED HISS work done on the

usability of information arising from NHIS about life style factors will promote also a

sensitization about the need of this kind of information in the studies about the effects of

environmental factors. Moreover, the restrictive privacy policies, arisen in Spain and Slovenia

after the project’s start, suggest a punctual consideration. It will be necessary to stress a clear

individuation of the subjects able to better manage these particular issues, linked to

environmental policies.

3. Future EU (and Global) applicability and reproducibility of demonstrated technology: the

same multidisciplinary methodology developed in MED HISS could be employed in future in

other countries to evaluate the beneficial effects of new policies (if any), in other geographical

areas (including in Eastern EU) to evaluate the effects of air pollution. If privacy regulation

will be less severe on the use of these data, each European country could have a cohort

representative of the whole population to monitor the health effects of air pollution or other

environmental issues at municipality scale.


4. Administrative part

4.1 Description of the management system

The project- management system has been structured in the following actions:

- Co-ordination and management (Action E1)

- Monitoring of the project (Action E2)

- Administration of budget (Action E3)

- Networking with other projects (Action E4)

- After-LIFE communication plan (Action E.5)

Action E1: The Project Manager is also the Coordinator of the project and belongs to the

Coordinating Beneficiary ARPAP. The Project Manager can rely upon one person supporting

the administrative and financial activities of the project. For each partner there is an

administrative staff that deals with all the financial and administration issues of the project.

We have already described with detailed information the Organization chart of the project

team and the project management structure in the Inception Report. It is useful here to

report that ARPAP conferred 4 technical temporary contracts: the personnel were asked to

monitor the following specific areas: “environmental data - exposure assessment” “air

pollution models and exposure assessment”, “survey data, health data and follow up”,

“technical coordination, communication and dissemination”. Each of the 4 contracted people

mentioned is working under the supervision of senior referents from ARPAP and from Italian

ABs, ENEA and SEPI.

ITALIAN PARTNERSHIP

Arpa Piemonte: public employee

+

Public employee from:

Department of Environmental Epidemiology or Department of Air Quality

as supervisor of the technical activity of 4 temporary contracts:

Martina Gandini (“env data, exp assessment”); Stefania Ghigo (“models, exp assessment”)

Cecilia Scarinzi (“health status…”)

SEPI (survey data, health data, follow up)

(socio economical variables) ENEA (air quality models)

Maria Rowinski: in charged of “technical coord, communication and dissemination” tasks.

CREAL (Spain), UPMC (France), NIJZ (Slovenia) are the partner

involved for the validation and choice of National data


The Project coordinator is responsible for the full implementation of the project and maintains

the contacts with the Commission and stakeholders in order to achieve the project activities

and to disseminate the project results. According to the Grant Agreement, each AB is directly

involved in the technical implementation of one or more tasks of the project.

The Steering committee, with representatives of all partners and integrated by two external

experts, has a transversal role with decision power and oversaw project implementation. At

each meeting or videoconference we foreseen a SC meeting, documented by the Minutes. The

work plan set down is regularly updated following the general scheme of the Gantt chart

(Annex 1- GANTT). Moreover the Gantt Chart had been and will be discussed and shared at

each meeting, for reassurance about the general consensus.

Formal agreements between the coordinating beneficiary and all the partners have been

established following the Life+ guidelines. The dates of all agreements were illustrated in the

Inception Report and a copy of all agreements were annexed and sent to the European

Commission.

National Institute of Public Health Slovenia (IVZ) communicated that the Institution changed

its name into NIJZ, with differences regarding only its status and organisation, after the

signature of the grant agreement by the Acting Director Marija Magajne. However this did not

change the role and the duties of NIJZ in the project. For this reason we made a formal

amendment. The revised Partnership Agreement was signed on December 2014 and a copy

was sent to the European Commission and to the Monitoring Team (Prot. ARPAP 3458

19/01/2015. However, a copy of the revised Partnership Agreement is enclosed to the present

Report (Annex 2 – Partnership Agreement NIJZ).

A second amendment has been requested by UPMC in order to add INSERM as

additional partner of the project. Following the reorganization of the UMR-S in France in

January 2014, the team of UPMC, “EPAR: Epidemiology of allergic and respiratory diseases”

changed its assignation from UMR-S 707 “Epidémiologie, système d'information,

modélisation” to UMR-S 1136 “Institute Pierre Louis of Epidemiology and Public Health”.

This UMR-S 1136 is a joint research unit, namely an administrative entity created by the

signature of a contract between one or more research establishments. UPMC (as a University)

and the Institut National de la Santé et de la Recherche Médicale (INSERM as a research

establishment) signed a contract to create the joint research unit « Institut Pierre Louis

d'Epidémiologie et de Santé Publique ».

The new structure changed the responsibility assignment and the team EPAR is now under

INSERM’s responsibility for all development tasks.

Contrary to FP7 and H2020 programs, Joint Research Units are not admitted in LIFE+

project. Therefore, to allow a joint work with EPAR participation, there is the need to allow

INSERM to be partner of the project, with a new financial and implementation distribution of

French funding (without modifications of the total budget).

The meetings were organized in order to involve all the ABs and in order to have the time, at

each institutional seat, to discuss and solve any technical or administrative problem eventually

encountered.

Since the project start four meetings were organized:

•Kick off meeting, 18-19 November 2013, Turin

•Health data protocol meeting, 20-21 January 2014, Paris

•Environmental data protocol meeting, 26 February 2014, Bologna

•Mid term meeting, 29-30 October 2014, Barcelona


Next meeting is planned in Slovenia, under the supervision of NIJZ, on July 2015.

At each meeting a specific part was devoted to the administrative and financial aspects of the

LIFE+ programme reporting. All the materials are uploaded and shared on the private area of

the website.

At the Mid Term Meeting organised in October 2014 in Barcelona the CB shared with the

ABs in details the dead lines for the Mid Term Report finalisation, giving a Time plan about

E1, E2 and E3 Actions.

Action E2:

Monitoring activities were carried out by the CB and consisted in evaluating the efficacy of

planned actions and verifying that the project’s objectives had been achieved. In order to

prepare comprehensive and compliant financial reports, the LIFE MED HISS Consortium

established a reliable system for collecting administrative and financial data of each AB.

In the website www.medhiss.eu, we organised a private area, named Platform, where ABs are

invited to upload time sheets, invoices, contracts, financial statements and any other useful

file, for Life + reporting purposes. Every quarter the CB checked all the files uploaded,

registered the information, requested clarifications where needed. The private area was useful

also to share Guidelines, Templates, link to Life+ Toolkit on the Internet as well as internal

Minutes, Letters from the European Commission, the Inception Report with the Annexes

already sent. The CB was able to monitor costs and to compare them to the budget on a

continuous basis.

We sent The Platform instructions (and Platform accounts) on May 2014 and we were able

during the Second Monitoring visit in Turin, in December 2014, to show all data acquired.

Also for the future, a regular consultation of the material uploaded into the platform will give

a quick view of the administrative and financial reporting status of each partner.

A check list focusing on administrative and financial reporting was distributed on January

2014 to check the compliance of the AB to the Common Provisions rules. This document has

been updated and discussed during the Mid Term Meeting (Annex 26 - Updated Financial

check list).

Internal audits before the draft of the Mid Term Report, to check available information

uploaded into the Platform, have been performed in June and in October 2014.

As suggested in the letter ENV/E4/FD/SEB/ps, a monitoring protocol was developed (Annex

C – Monitoring protocol), together with the first monitoring report (Annex 4 of the Inception

Report). A second monitoring report is now enclosed, together with the intermediate Progress

Report (Annex 3 – Monitoring reports).

The ABs were able to discuss about E Actions issues during:

• the Kick off meeting in Turin, November 2013 (the data collection; time sheets

examples, Common provisions distributed, financial reporting file commented);

• Health data protocol meeting, Paris, January 2014 (health data available, individual

information on confounders, grant agreements and methods of payment, eligible costs

from C.P. 2013, the EC letter received after the monitoring visit);

• Environmental data protocol meeting, Bologna, February 2014 (environmental data

available, air pollution information based on models vs monitoring stations, the VAT

declaration, financial statement files, check list – guidance for financial reporting

distributed, Platform of the web site);


• the teleconference of the Steering Committee to discuss “POLICY data exchange

through the www.medhiss.eu reserved area (= Platform)”, April 2014;

• the internal meeting ARPAP-SEPI we had in May 2014 to finalize the B2 Report with

Italian information and to connect B2 data with B1 available data by June 2014;

• the teleconference / phone call we had in June 2014 with CREAL and UPMC to have

clarifications about ecological approach protocol and about individual data collection;

• the Mid Term Meeting organised in October 2014 in Barcelona, where the CB shared

with the ABs the dead lines for the Mid Term Report finalisation about all Actions.

Action E3: The budget has been distributed according to the original plan to the ABs. A

continuous monitoring of the expenses has been conducted. Financial reports have been

prepared for the Inception Report, the Monitoring visits and the present Mid Term Report.

An extensive comment on Financial data is reported at Financial part of the present Report.

Action E4: Networking with other projects

A lot of projects and programmes on air quality and health are currently ongoing in the

Mediterranean. To achieve synergies between MED HISS and such initiatives, networking

activities to present our project has been held through the presence in many events, such as

projects communication conferences or meetings.

As indicator of project we list hereafter the 10 projects contacted and events shared:

1. MED-Particles - LIFE10 ENV/IT/327 final conference, Rome (Italy), 9-10 July 2013

2. International Society for Environmental Epidemiology ISEE conference 2013, Basel

(Switzerland), 19-23 August 2013

3. EPIAIR2 presentation project (together with the ESCAPE results), September 2013

4. Kick off meeting LIFE+ projects call 2012, Rome (Italy), November 2013

5. Aggiornamento e divulgazione: attività inerenti l’inquinamento atmosferico ed i suoi

effetti (course organized by ARPA), Turin (Italy), 2nd December 2013

6. Presentation at the Italian ministry of health within the final conference of the Italian

EPIAIR2 project, Rome (Italy), 16 December 2013

7. EXPAH - Population Exposure to PAH LIFE09 ENV/IT/000082, 11 June 2014

8. MAPEC - Monitoring of Air Pollution Effects on children to support public health

policies, Local workshop LIFE12 ENV/IT/000614, Turin (Italy), 14 October 2014

9. Poster session at ISEE-EUROPE 2014 | Young Researchers Conference on

Environmental Epidemiology CREAL, Barcelona, 20-21 October, 2014

10. Conférence PART’AERA et la qualitè de l’air, Turin (Italy), 12 March 2015

Networking activities focused on strengthen Italian cooperation through the participation of

national an international projects. One of communication activities objectives is to create new


liaison between stakeholders through the sharing of competences within networking activities

and the participation to national and international events. A complete list of contacts and

ongoing relationships is published on project website networking page

(www.medhiss.eu/node/9).

The following network will be contacted and informed about the project: European Health

Examination Survey Network (EHES), The European Community Health Indicators

Monitoring system in Europe Network (ECHIM), the European Union Health Surveys

Information Database Network (EUHSID) through the MEDHISS newsletter no.1 and

through the newborn twitter MEDHISS channel, before the end of March 2015.

ACTION E.5: After-LIFE communication plan

An after-LIFE communication plan will be written by the end of the project to set out in

details how the project will continue disseminating and communicating the results after its

end. Results obtained from the previous scheduled dissemination actions made during the

project lifetime, will be evaluated in order to identify lacks and possible improvements and a

report containing an after-LIFE communication plan will be ready within June 2016.

The results of the project will continue to be actively disseminated by the beneficiary and the

project partners within the Layman’s report and the website www.medhiss.eu, that will be

maintained for five years after the end of the project.

The MEDHISS Twitter channel will continue to spread project results and to communicate

with stakeholders; a strong collaboration between all partners is assumed also after the end of

the project.

We hope that our pilot project will produce the knowledge basis to build a European

surveillance system through a MED HISS 2 project.

4.2 Evaluation of the management system

The management system adopted has been generally successful. Each action has a beneficiary

responsible of the implementation, as in the e_proposal approved. It was necessary to increase

the responsibility of CREAL for the ecological study design: the restrictive privacy policies,

arisen in Spain and Slovenia after the project’s start did not allow to link individual data

(Surveys) to mortality and morbidity data registers. It was therefore necessary to set up this

alternative study design, and CREAL assumed the responsibility of the Protocol and of study

implementation and finalisation.

Whenever the Project Coordinator or any of the partners recognized delays or deviations from

the expected milestones, all the possible measures to be undertaken were evaluated by the

Project Coordinator. The management process has been facilitated by generally solid

collaborative relationship among partners. The partners participated to technical meetings

sharing their competence and experience.

The Project Coordinator, in charge of keeping the contacts with the EC and the monitor,

informed partners about specific requests and communication to/from the EC.

A particular attention is now due to the management of the amendment required by French

partner in order to include in the project the INSERM unit. Thanks to this amendment French

data will be provided by the INSERM. However, this will not affect the overall success of the

project.


The communication with the Commission has been handled by e-mail and correspondence

letters. We had frequents contacts (~ 80 e-mails) with the tutor Simone Pagni of the LIFE

ENV Monitoring Expert, Neemo EEIG – Timesis, who monitored the activities and the

compliance of the project deliverables and milestones with what declared in the proposal.

Moreover, he gave advice on relevant problems as the amendment required and now

terminated for NIJZ and the participation of UPMC with the associated INSERM to the

activities foreseen in the project, now in resolution not with a joint unit research but with the

amendment to involve the new partner INSERM.

We had a First monitoring visit in December 2013 with the tutor of the project (Dr Simone

Pagni). We received from the EC some specific recommendation concerning financial aspects

and about the necessity of provide a protocol for E2 Action and progress reports in order to

allow a proper evaluation of the progress made overall in the project and in the single action.

We had a Second monitoring visit on 11th December 2014 to check the status of the project.

ENEA and SEPI, the Italian Partners, were involved and took part to it. As a consequence the

European Commission sent us a letter Ref. Ares(2015)42016 - 07/01/2015 (Annex 4 – Letter

of the Commission 2015) that highlighted that no significant changes to the work plan have

been introduced.


5. Technical part

The two issues targeted by the MED HISS project are:

1. to estimate long-term health effects of air pollution in four Mediterranean countries

(France, Italy, Slovenia and Spain), providing new evidence to support EU legislation

2. to implement an epidemiological cheap surveillance system to monitor these effects

over time.

During the development of MED HISS activities it became clearer that the main output was

the second of the above mentioned issues, i.e. the set up of a cheap surveillance system.

The proposed low-cost approach, suitable for surveillance, is based on linkable resources as

exposure from National air pollution prediction models, mortality and hospital admissions

registries and NHISs, mandatory and therefore available in all European countries. In

particular, NHISs contain representative samples of the general population, covering both

urban and rural areas. Each individual is linkable to mortality and hospital admissions

information. The measure of exposure is assigned through the national deterministic

dispersion models (in France-CHIMERE, in Italy-MINNI, in Slovenia-ARSO and in Spain-

CALIOPE) integrated with monitoring stations information. Where this approach could not be

set up, an ecological study - an even cheaper system - will be tested. It’s accuracy will be

validated in Piedmont (Italy), where both type of studies are carried on.

Preliminary results on Italian country, at current status based on PM2.5 and one year of

exposure, confirm the robustness of the system set up (Annex 8 - Preliminary results PM2.5

year 2005 Italy).

Some issues need further evaluation: how to use information deriving from all the year of

exposure and how to deal urban/rural differences. Both these aspects are under discussion and

a final decision will be included in action B4 protocol, that will be finalized by the end of

September 2015.


5.1. Technical progress, by task

B.1 Pollutant data mapping

The objective of this action is to build up a map at municipality scale of air pollution for each

country involved in the MED HISS project, combining two sources of information: air quality

monitoring network and air quality numerical models. Due to the delay in the starting of the

project, the beginning of this action was slightly postponed; the first action meeting was held

in Bologna on 26th February 2014.

The B1 action consists of four sub-actions: B1.1: protocol, B1.2: data collection, B1.3: air

quality mapping, B1.4: exposure assessment. B1.1 protocol has been finalized and already

delivered with the Inception Report (“Annex A- Air pollution mapping protocol”). This

protocol covers the whole action B.1.

After the definition of a common protocol (Annex A- Air pollution mapping protocol), sub-

action B1.2 have been carried on. ENEA and CREAL provided data respectively for Italy and

Spain by the end of June 2014. ENEA provided MINNI modelling system output, statistical

scores and observed data of NO2(x), PM2.5, PM10 and O3 monthly mean concentrations for

the years 1999, 2003, 2005, 2007, 2010. A new release of 2010 MINNI output and statistical

scores has been delivered by ENEA at the end of December 2014. ARPAP collected Italian

cartographic data (municipality and built-up area boundaries). CREAL provided CALIOPE

modelling system output, statistical scores and observed data of NO2(x), PM2.5, PM10 and

O3 monthly mean concentrations for the years 2009, 2010, 2011, 2012, 2013 and also

cartographic data (municipality and small area boundaries, built-up areas). A new release of

CALIOPE output, statistical scores and observed data has been delivered by CREAL at the

end of January 2015. NIJZ provided data coming from monitoring stations and cartographic

information by the end of June 2014; output of Slovenian modelling system will be available

by the end of June 2015. This delay is due to serious temperature bug of current operational

version (ALARO-0), that we have been able to bypass for the operational purposes but not in

the case of hindcasting and are fixing. Some improvements have been obtained with new

version of meteorological model (ALARO-1), that is still in testing phase and not yet in full

operational mode. In March the decision regarding the use of version (ALARO-0 or ALARO-

1) will be made on the basis on more test cases of both versions. Therefore at the beginning of

April they will start with meteorological and consequently chemical-dispersion hindcast. Due

to the low number of monitoring stations on the Slovenian territory, it is likely that

assimilation procedure will not be done for PM2.5 and NO2. For PM10 the number of

monitoring stations is higher, so the opportunity to assimilate data will be evaluated. All

national models comply with the INSPIRE directive 2007/2/EC.

Until now UPMC was not able to acquire the exposure data arising from CHIMERE, but we

are confident that this problem could be overcome with the participation of INSERM as new

partner, thanks to the amendment necessary for the project.

Descriptive statistics of collected variables are attached (Annex 5-Descriptive statistics on

pollutant data collected).


According to the protocol (Annex A- Air pollution mapping protocol), statistical scores

between simulated and observed data have been analysed by ARPAP in order to evaluate the

“goodness of fit” of CTM models for epidemiological purposes. Concerning annual mean

concentrations, results about the CALIOPE model output, that is already assimilated ( that is

observed data are included in the modelling system), show a good compliance between model

and observed data for all the pollutants. MINNI output results show a quite good accordance

for the O3 and NO2 concentrations and an acceptable one for the PM10 and PM2.5

concentrations; the analysis highlights some underestimations of concentration level in the

medium-small towns.

Thus to provide a more realistic representation of pollutant spatial distribution, ARPAP

combined MINNI model output with air quality monitoring data (sub-action B1.3). According

to the protocol, three different data fusion techniques have been tested on the Northern Italy

domain for the year 2010. Looking at preliminary results, it seems that the performance of

kriging with external drift methodology (ked) is better than the one of the other two methods,

especially in situation where the spatial coverage of monitoring stations is low. Moreover the

ked is computationally the most efficient technique. If necessary, this methodology will be

applied also to Slovenian data. For Spain, as reported above, this step was not necessary since

monitoring stations are already included in the CALIOPE model.

In order to provided the exposure assessment at municipality level (sub-action B1.4), the

gridded assimilated concentrations fields are up-scaled from the grid point to the municipality

one. ARPAP carry out Spain exposure assessment at municipality and small-area level for all

the pollutants and for the years 2009, 2010, 2011, 2012, 2013. Up-scaling procedure is also

ready for Italy. For Slovenia it will be done in the next three months. The final exposure

assessment for Slovenia and Italy will be available at the end of June 2015. Details are given

in Annex 6 – Exposure assessment study.

During the Mid Term workshop held in Barcelona at the end of October 2014, the external

expert Xavier Querol suggested to carry out an analysis of the “urban delta” - namely of

possible bias between simulated data and those observed from monitoring stations located in

big cities. A sensitivity analysis included in the protocol of Action B.4 (Annex 7- Statistical

protocol(draft)) will be done using data from monitoring stations instead up-scaled

concentrations in Spanish cities with more than 250000 inhabitants.

The final data produced as output of action B.1 will be pooled in action B.3 with data from

action B.2 according a specific protocol, included in initial steps of statistical protocol of

action B.4 (Annex 7-Statistical protocol(draft)).

The map of PM2.5 of Italy for year 2005 at municipality level has been already produced and

pooled with health data (Action B.2), in order to perform preliminary analyses on mortality

and hospital admission using one year of exposure and seven years of follow-up for each

subject. These preliminary results have been presented at the Mid Term workshop in

Barcelona. A summary is attached to the report (Annex 8 - Preliminary results PM2.5 year

2005 Italy).

Action 2013 2014 2015 2016

Number/name of action III IV I II III IV I II III IV I II

Proposed

Actual (approved in

inception report)

B.1 Pollutant data

mapping

Actual


Name of the deliverable Deadline from

inception report

Status

Minutes of first action meeting 28/02/2014 Done

Air pollution mapping protocol 28/02/2014 Done

Air pollution data set 30/06/2014 (except

NIJZ)

Done (except France

and NIJZ)

Exposure assessment study 31/03/2015 Done

The map of air pollution data at

municipality scale for each

country and each pollutant

31/03/2015 Postponed to

30/06/2015 for

Slovenia, Italy (for

which processing step

is ongoing) and France


B.2 Survey and health data collection

The aim of this action is to produce a validated database containing health information.

Database contains cross-sectional data from NHISs linked to follow-up data for mortality and

morbidity; other health information systems are also possible to link. Length of follow-up

could be different across different health outcomes or different countries, but the coverage of

pollutant exposure data and latency for each health endpoint should have been guaranteed

(this procedure is shown in Action B.3).

These results will be used in the implementation of individual-level approach (for statistical

details see Action B.4): an analysis based on individual record linkage between NHISs and

health information systems, among partners where individual linkage is possible.

A second database is in progress, incorporating observed and expected data on mortality

and morbidity in addition to socio-demographic and health characteristics (e.g. percentages of

smokers in an area) of all areas of interest (municipality or small area of each Nation/Region,

as defined in B.4).

This information will be joined to exposure data and analyzed following an ecological

approach, that will be implemented in Spain and Slovenia and tested in Piedmont region.

The latter approach, taking municipality or small areas as the unit of analysis, is an alternative

analysis that may be useful for countries that are not able to access the individual data from

the NHISs or that are not able to link these data to the mortality/hospitalization registries.

In Italy that is carrying on also an analysis at individual-level, the results of both approaches

on Piedmont region will be compared to assess the validity of the ecological analysis.

As indicators of progress we prepared a protocol for health data collection (“Annex B –

Survey and health data protocol” using all the published evidence on long-term health effects

of air pollution and taking into account the available health data in all the countries involved

in the project), a report on health data available and health endpoints for individual analysis

(Annex 9 – Individual approach: data available and health endpoints), and the descriptive

results of ecological analysis (Annex 10 - Ecological approach: health endpoints). Up to now

UPMC was not able to acquire health data but we trust that this problem will be solved thanks

to the amendment and the participation to the project of INSERM unit.

The protocol for health data collection contains:

• identification of the NHISs that are going to be used (definition and size of the population

involved, survey information gathered),

• identification of linkable databases with predictable available years,

• definition of health outcomes of interest,

• identification of possible confounders and effect modifiers, including co-morbidities.

The report about health data available and health endpoints contains:

• harmonization of confounders, effect modifiers and co-morbidities variables, necessary

because of variation across countries in measurement and classification of variables,

• percentages of successfully linked individuals (in countries where it is possible),

• basic summary statistics on health endpoints.

An alternative data source for the same health information, a compulsory additional individual

information requested from European Commission (as information on emigration), a

definition of other susceptible sub-population and other specific health endpoint will be

evaluated.


Italian update of follow-up for mortality and morbidity causes (related to the resolution of

administrative problems for data capture), in addition to the formal inclusion of INSERM as

new partner (after the finalization of amendment) has caused a delay of three months for the

“final report on population data”. This delay however does not affect the success and the

compliance of the deadline of the related actions (subsequent Actions B.5, B.6 and B.7).

These three actions started thanks to the evidence we already had and to the fact that we

planned a buffer period for actions in order to manage possible delays. Finally we will be able

to increase the work of the partnership on this action if it will be necessary.

The usage of health data information after the end of the project, as specified afterwards,

could ensure updated results of long-term effects of air pollution and continuous

surveillance’s process.

The Italian cohort derives from the NHIS of years 1999 and 2000. The individuals in the

survey have been already linked with mortality and hospital admissions with seven/nine years

of follow-up (1999-2007, with exception of 2004 and 2005 years, for mortality and 1999-

2007 for hospital admissions). Therefore, thanks to the map of PM2.5 of Italy for year 2005 at

municipality level already produced, preliminary analyses on individual study have been

carried on. Statistical methodology and variables used derived from the literature review.

These preliminary results have been presented at the Mid Term workshop in Barcelona. A

summary is attached to the report (Annex 8 - Preliminary results PM2.5 year 2005 Italy).

Action 2013 2014 2015 2016


Proposed

Actual (approved in

inception report)

B.2 Survey and Health

data collection

Actual


inception report

Status

Minutes of second action meeting 07/02/2014 done

Health data collection protocol 25/03/2014 done

Report on health data available and

health endpoints

30/06/2014 Done for Italy (postponed

for France)

Final report on population data after

linkage procedures

31/03/2015 rescheduled on 30/06/2015


B.3 Pooling country specific data

In this action, data collected in actions B.1 and B.2 are pooled together. Harmonization of

variables coming from NHISs is in progress, according to the timetable. For sake of

simplicity, protocol concerning this aspect will be included in the protocol for action B.4

Annex 7- Statistical protocol (draft).

This can be performed taking into account an optimal set considering other European NHIS’s.

The task is done with under the supervision of SEPI, and thanks to the networking outside

LIFE programme with the European projects DEMETRIQ (DEveloping MEthodologies To

Reduce IneQualities in Determinants for Health) and EUROTHINE (Tackling Health

INequalitiesin Europe: an integrated approach). The same harmonization will be done among

partners that will carry on the “ecological study”.

Where useful, country-specific results (Actions B.5, B.6 and B.7) will be produced where

variables/levels were aggregated.

In order to assign to each individual a seasonal or annual mean value for each pollutant in the

period under study, health and pollutant data are linked in this action.

Feasibility study to create a common shared European air quality map useful for

epidemiological purposes is in progress. It will be interactive, permitting to have an

instrument to share all the elements arisen from this project.

Mid Term workshop took place in October 2014. Minutes are attached to this report (Annex

25 – Minutes of the meetings).

Indicators of progress will be scheduled in the third trimester of 2015.

For their relevance to adjust the hazard and their use in the scientific literature, the

standardization of socio-economic variables will aim to ensure as much international

comparability as was possible on the basis of national surveys.

Action 2013 2014 2015 2016


Proposed B.3 Pooling country

specific data Actual (approved in

the inception report)


inception report

Status

Minutes of the MID TERM

Workshop (Barcelona) 01/12/2014

Done

Feasibility study for a common air

quality map for epidemiological

purposes

30/09/2015

Not due. Confirmed.

Report of descriptive statistics of

variables that will be used in the

analysis

30/09/2015 Not due. Confirmed.


B.4 Development of the statistical modelling strategy for the analysis of the

long-term effects of air pollutants on health endpoints

The aim of this action is to develop statistical models useful to analyze the data collected and

standardized in the three previous actions. Two different types of analyses will be carried on.

For the individual study, a first level of analysis will be carried on using Cox proportional

hazard model, in order to have a comparison with results from literature, with the annual

average of PM10, PM2.5, NO2 and O3 (seasonal value) in turn as predictors, while adjusting

for individual confounders defined in Action B.3. Basic and sensitivity analyses will be

implemented to obtain literature comparable results and European-specific risks.

Further improvements of the model and sensitivity analyses are under discussion among all

the partners in the protocol (Annex 7 – Statistical protocol (draft))

As future work, dose-response function will be evaluated.

The second part of the statistical protocol will deal with ecological study, to overcome the

linkage limitations due to the restrictive legislation in Spain and Slovenia, but which are likely

to interest other EU countries. In the ecological study both outcomes and confounders are

collected at an aggregated level (municipality or small areas). A draft version of the protocol

which is circulating among all the partners is attached (Annex 7 – Statistical protocol (draft))

Italy partner permits a comparison between the two methodologies using a sub-area, the

Piedmont region.

The statistical strategy will be discussed during the fourth action meeting that will be held on

15th and 16th July, 2015 in Lubiana, to check the status of work.

Indicators of progress will be scheduled in the third trimester of 2015.

Comparison among individual and ecological approaches’ results (Actions B.5, B.6 and B.7)

will lead to ensure the interchangeability of the two methodological approaches with the

prevalence of the ecological model if privacy laws become more restrictive and more

widespread.

Action 2013 2014 2015 2016


Proposed B.4 Development of the

statistical modelling

strategy for the analysis of

the

long-term effects of air

pollutants on health

endpoints

Actual

(approved in the

inception report)


inception report

Status

Minutes of fourth action meeting

15/07/2015 Organizing on 15th

and 16th

July.

Evaluation of statistical

modeling details completed


Report of the statistical modelling

that will be used in the analysis 30/09/2015

Not due. Confirmed.


B.5 Health effects of air pollutant on total and cause-specific mortality. Country-specific

results and meta-analysis

The aim of this action is to put in practice the methodological framework defined under

Action B.4, with reference to the mortality endpoints defined under Action B.2.

In particular, for Italian, Piedmont and French cohorts, Cox proportional hazard model on

total or cause-specific mortality causes will be implemented. Survival results will be regressed

against PM10, PM2.5, NO2 and O3 (seasonal effect) in turn, while adjusting for individual

modifiers as described in the protocol of Action B4.

Using Spanish, Slovenian and Piedmont data a Poisson model will be implemented; mortality

rates of areas will be regressed against PM10, PM2.5, NO2 and O3 (seasonal effect) in turn,

while adjusting for individual modifiers if available.

The result of the analysis will be the percent increase in risk of death associated to 10 ug/m3

of each pollutant.

If the ecological analyses will reveal that is also a robust method, the ecological approach’s

results will be meta-analyzed, otherwise only country-specific estimates will be considered.

Results will be discussed at the 2015 Barcelona meeting (Action D.3).

Indicators of progress will be scheduled at the end of this year.

Literature, updated of follow-up and new standardized surveys could guarantee the update of

project’s results.

Action 2013 2014 2015 2016


Proposed

B.5 Health effects of air

pollutant on total and cause-

specific mortality. Country-

specific results and meta-

analysis

Actual

(approved in

the inception

report)


inception report

Status

Report on mortality analysis 15/12/2015 Not due. Confirmed.

One draft paper for scientific

journals 31/12/2015 Not due. Confirmed.


B.6 Health effects of air pollutant on total and cause-specific hospitalizations. Country-

specific results and meta-analysis

The aim of this action is to perform the statistical analysis of health effect of air pollutant on

hospital admissions for all natural causes, all cancers, lung cancers, cardiovascular diseases,

respiratory disease, asthma and other outcomes defined in actions B2/B3.

The analysis, like for mortality, will be performed using a Cox-proportional hazard model for

Italian, Piedmont and French cohorts, and a Poisson model for Spanish, Slovenian and

Piedmont data referred to area instead inhabitant as statistical unit.

A final report will be produced with the main country-specific and overall results of the

project, if in Piedmont the comparison among individual and ecological approaches

guarantees the robustness of the second type of analysis.

Results will be discussed at the 2015 Barcelona meeting (Action D3).

Indicators of progress will be scheduled at the end of this year.

Literature, update of follow-up and new standardized surveys could guarantee the update of

project’s results.

Action 2013 2014 2015 2016


Proposed

B.5 Health effects of air

pollutant on total and cause-

specific hospitalizations.

Country-specific results and

meta-analysis

Actual

(approved in

the inception

report)


inception report

Status

Report on morbidity analysis 15/12/2015 Not due. Confirmed.

One draft paper for scientific

journals 31/12/2015 Not due. Confirmed.


B.7 Health impact assessment

This action aims to apply the known methods of health impact assessment in air pollution to

give an estimate of this problem in four European countries. Studies like the present one use

existing evidence to estimate the proportion of mortality and morbidity (cases attributable to

air pollution) that could be prevented if average ambient concentrations were reduced to target

concentrations. This will be done for the health outcomes whose risks are calculated in actions

B.5 and B.6. and for specific age groups.

The external expert (Nino Kunzli) that has a wide and well known experience in HIA will

supervise the methodology and will follow and monitor all the steps of this action.

This action started on 1st January 2015.

For comparability purposes, a preliminary review of epidemiological literature has been made

(Annex 11 - List useful for literature review).

Counterfactual scenarios will be defined based on EU directives and WHO recommendation.

A draft version of the protocol is attached (Annex 12 – HIA protocol (draft)).

We will follow findings from literature review and the results from epidemiological analysis

of this project to define risk coefficients to apply in impact calculations. The assessment will

address long-term effects of mortality and morbidity for some specific causes, in terms of

counts, years of life lost and DALY’s. This evaluation will be made on surveys’ population

and whole exposed population, by subgroups of interest.

E.g., quantitative impact assessment will be implemented using methods taking into account

the background incidence rate of a disease in the general population of each country and the

number of people exposed, the excess cases attributable to different counterfactual levels of

pollution will be calculated, starting from values of excess risk in the exposed population,

which derives from the epidemiological findings of the project.

A Bayesian approach will be used for calculating the total attributable number of cases. To do

this, for each country we will use national risk estimates shrunken on the pooled meta-

analytical ones, to guarantee statistically significant results even where the size of the cohort

could not guarantee a significant risk estimate.

Concerning ecological study, a methodology for the calculation of attributable number of

cases will be discussed and inserted in the protocol in the next months.

Action 2013 2014 2015 2016

Number/name of

action

III IV I II III IV I II III IV I II

Proposed B.7 Health impact

assessment

Actual (approved in




inception report

Status

Protocol for the HIA procedures 30/06/2015

Not due. Confirmed.

Preliminary assessments of the

impact on overall and country-

specific mortality


Preliminary assessments of the

impact on overall and country-

specific morbidity



C.1 Monitoring of the impact of the project

Communication with stakeholders is always critical for organizations, the first step was

creating a website and a list of stakeholders based on a “stakeholders analysis” (see Annex E -

Stakeholders mailing list of Inception Report). Starting from this Annex our working group

decided to create different mailing lists targeted on local, national and international levels,

with partners contribution. This should be an effective strategy to identify key stakeholders,

then disseminate MED HISS message and reach the desired effect (Annex 28-

STAKEHOLDERS strategy_draft).

For Italian and Spanish partners, the stakeholders involvement is already established in the

framework of consolidated and permanent relationships. For the other partners, LIFE MED

HISS is the chance to create or to strengthen links with regional and national stakeholders.

The mid term report will be published on the project website and available to stakeholders

once sent to the Commission.

Our stakeholders communication activities planning includes some phases:

1. Build an ongoing “Map of stakeholders” (Annex 13-STAKEHOLDERS map)

2. Build four “Targeted mailing lists” (Annex 14-Targeted mailing lists)

3. Drafting 3 or 4 newsletter to address to “targeted mailing list” (newsletter n.1 – Annex 15

–Newsletter n.1_draft)

4. Draft of the epidemiological map “Interactive map draft” (deliverable shifted to December

2015) Annex 16-Interactive map ideas

5. Match with partners a strategy to involve stakeholders in long-term planning thanks also

to the production of a factsheet

1. The stakeholders map has been built to study the relationship between subjects to focus

and monitor a stakeholders communication ongoing strategy: categorizing stakeholders

based on their influence on strategic technical goals provides a road map for allocating

communication resources to run stakeholders management. The more influence a

stakeholder has in helping to meet strategic objectives, the more time and attention it

should receive.

2. Everyone of the four “targeted mailing list” is based on direct or indirect involvement and

the brainstorming with key contributors has helped building an exhaustive list of

stakeholders to identify key points of contacts.

Here are the ongoing main “targeted mailing lists”:

- MEDHISS Stakeholder list SLOVENIA (number of persons: 17)

- MEDHISS Stakeholder list CREAL (number of contacts: 5)

- MEDHISS Stakeholder list UPMC (number of institutions and groups of interest:

14)

- European Community Health Indicators and Monitoring' (ECHIM), contact

persons in member states (number of persons: 97)

A targeted mailing list of NGO and environmental associations will be finalized in April

2015.


3. The first newsletter will be sent by the end of April 2015 to the “Stakeholders mailing list

of Inception Report” and to the “targeted mailing lists” and will reached about at least 400

stakeholders contacts.

4. The preliminary work in preparation of the “pollutant data map” has been done and a

document with the structure of the map has been draft (Annex 16-Interactive map ideas).

The map will be ready to be presented to stakeholders and to the public at the end of year

2015 (with a delay of three month comparing to what declared in e-proposal).

5. Every project partner will be contacted to point out its main stakeholders network and to

describe together with the coordinating beneficiary its particular stakeholders

communication strategy. The production of a factsheet clearly describing the vision of the

project will help this pilot project to develop its potentialities.

Action 2013 2014 2015 2016


Proposed C.1 Monitoring of the

impact of the project Actual (approved in



inception report Status

Report on epidemiological

evidences to support EU policy on

environment Initially not required

Delivered with

inception report (Annex

F- Epidemiological

evidences to support

EU policy)

Presentation of epidemiological

air pollution map to European

Union and local stakeholders 30/09/2015

Postponed to

31/12/2015 for

technical problems

with Slovenian

modeling system Report on the assessment of the

usefulness of the pollutant data

map 31/05/2016 Not due. Confirmed


C.2 The Assessment of the socio-economic impact of the project actions on the local

economy and population

This Action is provided for last quarter of 2015. At the current status of the project, there are

no reason to foresee a delay with this action.


5.2 Dissemination actions

The objective of the LIFE-MED HISS project is to contribute to the development of an

innovative method to set up a surveillance system. The communication plan aims at

facilitating exchanges of experience through an active dissemination to the stakeholders of the

results.

Dissemination activity will support communication of information and awareness raising in

this fields and promote the dissemination results of projects under the EU area. This will

increase the participation in stakeholder consultations or policy discussions related to health

and environment legislative acts.

The purpose of the project is to bridge the gap between the idea of our pilot project and its

realisation and large-scale application to support future projects and encourage an ongoing

methodological research. The dissemination of results is essential for ensuring that project

results would be widely applied.

D.1 Dissemination to policy and decision makers and to the public

Decision and policy makers at local (city or region specific), national (Italy, France, Slovenia,

Spain) and European (EU) levels has been informed during the pass off the project. ARPAP,

the project coordinator, is the technical executive branch of the Piedmont region, and has

frequent contacts with local stakeholders of the most polluted Italian areas.

List of deliverables:

1. As project coordinators we have assured the correct use of LIFE logo on documents,

visual supports and durable goods, giving instructions about it to all partners during

kick-off meeting and mid-term workshop.

2. As project coordinators we have checked all partners correct erection of notice boards

and we have received from the partners 6 notice board photos (Annex G -

Photos_notice board). At present 3 national language version are available (French,

Italian and Spanish).

3. The project website is the main MED HISS dissemination instrument and has

regularly been updated since the beginning of the project by ARPAP. The

circulation/sharing of progress reports is guarantee by the publication on the reserved

area (platform). The dissemination/circulation of project reports and publications is

guaranteed by the regular update of MED HISS website. Reports are available to the

public through the project website.

4. Local, national and European stakeholders will be updated through some newsletters

(Annex 15 –Newsletter n.1_draft) about project news and results thanks to the

production of targeted mailing lists (Annex 14-Targeted mailing lists). Local

authorities and population are particularly sensitive to environmental problems

according to the importance of the impact of air pollution on human health.

5. The MED HISS Mid term meeting took place in Barcelona at the end of October

2014, all project partners has been invited and the two external experts too. The

meeting has been foreseen throughout the project life to summarize and discuss Action

B1 and B2 mid term early objectives.


The Agenda of the meeting comprised a collection of opinions on the state of the art of

the project, to point out main difficulties and the way to overcome them, following

meeting date and venue. We include Barcelona meeting photos and PART’AERA

networking photos (Annex 17-Photos Barcelona meeting and PART’AERA

networking)

6. ARPAP has published two web news: DORS-Piedmont Region Health Promotion

Documentation Center (www.dors.it/pag.php?idcm=5374) and ISS-Istituto Superiore

di Sanità (www.epicentro.iss.it/temi/ambiente/ambiente-indice.asp). In addition a note

on MED HISS project was published on EU - LIFE Programme website

http://ec.europa.eu/environment/life/project/Projects/index.cfm?fuseaction=search.dsp

Page&n_proj_id=4518 (Annex 18-Press cuttings).

7. The future incremental use of Social Media (we will create by the end of April 2015

@MEDHISS Twitter user) network will increase the number of contact and improve

the effectiveness of dissemination actions.

ISEE-Europe has organized a 2-day Young Researchers Conference in Environmental

Epidemiology on Monday 20 and Tuesday 21 October 2014 at CREAL, Barcelona.

The conference has covered all areas of research in environmental epidemiology. A main

theme of the conference has been the “Exposome” due to the increasing interest in this area of

research in environmental epidemiology. The format of the meeting has promoted discourse

and has included invited and submitted presentations, posters and extensive discussion time.

ARPAP has presented three posters of which one on MED HISS project. (Annex 19-ISEE

2014 poster).

ISEE meeting 2015, that will be held in São Paulo, Brazil, from August 30th to September

3rd, ARPAP has decided to give every partner the possibility, either if not present in São

Paulo, to propose an abstract according to the technical attitude in MED HISS framework.

During the conference ARPAP will present two abstracts to the international framework for

the creation of a wider international network (Annex 20-Abstracts ISEE 2015).

Action 2013 2014 2015 2016


Proposed D.1 Dissemination to

policy and decision

makers and to the public Actual (approved

in the inception

report)


inception report

Status

Annual conference of the

International Society for

Environmental Epidemiology

communication (oral or poster)

20/08/2015 Abstract submitted

(Annex 20-Abstracts

ISEE 2015)


D.2 Web design, development and results displaying

The project website www.medhiss.eu has been revised once in the first half of 2014 and a

second improvement is previewed in March-April 2015: the contents have already in part

been reviewed and the information has been updated. All “news and events” section has being

rebuilt together with Social Media functionalities. A new tool to visualize photos will be

installed in by the end of April 2015.

List of deliverables:

1. As project coordinator we have built the website and correctly published the LIFE

logo on website and project documents.

2. Notice boards national language version have been published in the private area of

the website (presently available the Italian, French and Spanish version) and soon

available for the public from the public area.

3. The website has been regularly updated: the number of visits of the website has been

monitored through a counter. The website has been published under the ARPA

Piemonte website as a link to the project. Number of feedbacks on the project’s results

in the website have been monitored (number of the visits of websites, until now:

around 2500). The information on progress and results have been regularly updated. A

collaboration tools (see Platform) has been built and regularly implemented.

4. Four mailing list have been published in the platform, available to all partners for

download.

5. Meetings photographs have been regularly published on the website.

6. Press cuttings overview ( Annex 18-Press cuttings).

7. Links Social Media: Goto meeting, Doodle e Twitter, link to MEDHISS website

project on every Linkedin personal profile of MEDHISS working group participant.

Project website published under ARPA Piemonte website and its updating:

http://www.arpa.piemonte.it/approfondimenti/temi-ambientali/ambiente-e-

salute/dipartimento-tematico/progetti-1/progetto-medhiss

Exchange of documents and information is guaranteed by the reserved part of the website

(Platform).

Action 2013 2014 2015 2016


Proposed D.2 Web design,

development and results

displaying Actual (approved

in the inception

report)


inception report

Status


Development of website 28/02/2014 Completed on time Reports of activities related to the

website use 31/03/2016 Not due. Confirmed

Reports and minutes uploaded

31/05/2016

Confirmed. Until now

all the minutes and

reports have been

uploaded on the

website


D.3 Conference spanning the topics of the project

The Conference spanning the topics of MED HISS project is provided for last quarter of

2015. At the current status of the project, there are no reason to foresee a delay with this

action.


D.4 Layman’s report developing for dissemination

According to the scheduled timetable, this action did not start yet. We confirm that the

expected start will be at the beginning of 2016. At the current status of the project, there are

no reason to foresee a delay with this action.


5.3 Evaluation of Project Implementation

In the following section, a summary of the methodology applied is presented, together with

the results attained within each Action and their evaluation. In terms of cost-efficiency, it will

be described more in detail in the financial section. However, it is important to note that the

expenditures for all actions are generally consistent with those reported in the original

proposal.

Task Foreseen in the

revised proposal Achieved Evaluation

Definition of a

common operational

and standardized

protocol on

methodology to

combine monitoring

and modelling data

for air quality

mapping / Action B.1

Definition of an

operational and

standardized protocol

on methodology to

upscale air quality

data from grid scale to

city-specific scale/

Action B.1

YES.

These two

protocols were

merged in the

“Pollutant data

mapping

protocol”,

already presented

in the inception

report. The

protocol

indicates the type

of data that have

been collected,

the comparison

of CTM’s model

with monitoring

stations data,

data fusion

techniques to

integrated the

two sources of

information and

exposure

assessment

methodology.

YES. The partners involved

contributed to the draft of the

protocol.

Country-specific

report on basic

summary statistics on

the variables collected

(mean, standard

deviation, median,

minimum, 5th

percentile, 95th

percentile, maximum)

by year and by season

/Action B.1

YES. Descriptive

statistics have

been reported

both for

modelling CTMs

data and

monitoring

network

YES (except

for France)

Report was finalized by ARPAP

on the basis of data provided by

all partners (postponed for

UPMC and INSERM)


Map at municipality

scale / Action B.1

YES.

Action B1

protocol is

applied to

transpose air

pollution level

from grid to

municipality

scale.

YES for

Spain. For

Italy is

ongoing. For

Slovenia and

France it will

be produced

by the end of

June 2015

According to the protocol, the

map was produced for Spain and

is ongoing for Italy.

Other issues arise concerning

goodness of fit of the model in

cities with more than 250.000

inhabitants. The use of only

monitoring stations will be

performed as sensitivity analysis

in Action B4 protocol.

Health data collection

protocol / Action B2

YES. Data

collection has

been performed

both for

individual and

ecological study

YES Report was finalized by ARPAP

on the basis of data provided by

all partners and under the

supervision of SEPI

Report on health data

available and health

endpoints / Action B2

YES YES (except

France)

Only an amendment could lead

to the achievement of the results

related to the individual analysis

in France thanks to the

collaboration of INSERM

Final report on

population data after

linkage procedures /

Action B2

YES Not yet,

according to

the delayed

timetable

SEPI is the leading of this action

that has been scheduled again

due to legislative limitation

For each type of data,

definition and

dissemination of an

operational and

standardized protocol

/ Action B.3

Information gathered

for EU countries not

covered by this LIFE

project /Action B.3

YES Not yet.

According to

the timetable,

this work is in

progress

ARPAP is leading this action,

with the contribution of SEPI,

mainly for what concern

information gathered for EU

countries not covered by MED

HISS. This is done thanks to the

networking outside LIFE

programme with the European

projects DEMETRIQ and

EUROTHINE

For each type of data,

report on the pooled

data base with

information on the

pooling process and

summary statistics /

Action B.3

For each pooled

dataset the final

percentage of record

successfully linked

/Action B.3

YES Not yet.

According to

the timetable,

this work

needs to be

done.

The report will be produced at

the end of this action.

For what concern map, it is in

progress thanks to the issues

arising from this project. It will

be a map with information useful

also for the other EU countries to

set up this surveillance system.


A common air quality

map for

epidemiological

purposes /Action B.3

An analytical protocol

on data analysis

/Action B.4

YES Not yet.

According to

the timetable,

this work is in

progress

A draft version of the protocol is

circulating, both for individual

and ecological study. It will be in

an advanced version for Lubiana

meeting

Exploratory results on

the health effects of

air pollutants and of

possible sensitivity

analyses /Action B.4

YES.

Preliminary

results on

individual study

have been

obtained for Italy

using exposure

assessment

development in

Action B1 and

statistical

methodology

derived from

literature review.

In progress Preliminary results of analysis of

PM2.5, year 2005 for Italy have

been presented at the Mid Term

workshop in Barcelona (Annex 8

- Preliminary results PM2.5 year

2005 Italy).

At least four (natural,

cardiac,

cerebrovascular,

respiratory mortality)

concentration

(exposure)-response

functions will be

available for each

pollutant, between

exposure to particles

and mortality

endpoints /Action B.5

YES Not yet.

According to

the timetable,

this work is in

progress

The methodology for the

exposure-response functions will

be included in Action B.4

protocol.

At least six (natural

causes, all cancers,

lung cancers,

cardiovascular

diseases, respiratory

disease, asthma)

concentration

(exposure)-response

functions will be

available for each

pollutant, between

exposure to particles

and morbidity

endpoints /Action B.6

YES Not yet.

According to

the timetable,

this work is in

progress

The methodology for the

exposure-response functions will

be included in Action B.4

protocol.

One Literature review YES Not yet. The literature review is in


of the impact

coefficients to be

applied for

comparison /Action

B.7

Protocol definition for

the HIA procedures

/Action B.7

Implementation of

spreadsheets for HIA

calculation /Action

B.7

Assessment of the

impact on overall and

site-specific mortality

/Action B.7

Assessments of the

impact on overall and

site-specific morbidity

Overall Health Impact

Assessments of

simulated scenarios of

reductions in

emissions

According to

the timetable,

this work is in

progress

progress, as well as the protocol

definition for the HIA

procedures

Possible revision of

local environmental

policies taking into

account long term

health effects of air

pollution /Action C.1

Possible prevention

programs directed to

sub-population groups

particularly affected

by long term health

effects of air pollution

/Action C.1

Assessment of the

usefulness of the

pollutant data map

/Action C.1

Build four “Targeted

mailing lists” /Action

YES

Not yet.

According to

the timetable

this work will

be ended by

the end of

December

2015

The map is in progress: the idea

is to create an interactive map,

merging all the information

pointed out by MED HISS

project, realized as a user

friendly tool

The mailing lists are an ongoing

product that should be updated

from time to time


C.1

Build an ongoing

“Map of stakeholders”

/Action C.1

Drafting 3 or 4

newsletter to address

to “targeted mailing

list” /Action C.1

Match with partners a

strategy to involve

stakeholders in long-

term planning thanks

also to the production

of a factsheet /Action

C.1

NO YES,

completed in

part

The concrete part of the work

will be done in the next months,

according to the fact that the

project results are not available

now: we wish a good

cooperation between partners to

reach exhaustive results in

stakeholders communication

For each of the

scenarios, report on

socio-economical

impact of the increase

of air pollution in

population /Action

C.2

Socio-economic

impact measurement

of particular

subpopulations

/Action C.2

YES Not yet.

According to

the timetable

this work will

be done

starting from

October 2015

One mid-term

workshop /Action D.1

Number of invited

institution that will

follow the initiatives

(with participation to

the meeting, link to

the web

site or email

exchange) /Action

D.1

At least one

conference for each

country /Action D.1

YES YES (mid

term

workshop)

The two other

tasks will be

completed

when public

conferences

will be held

Alle partners will attend the

conferences: we wish a good

cooperation between partners to

reach exhaustive results in

dissemination activities

Project website

published under

ARPA Piemonte

website and its

YES YES Whenever necessary the

coordinator could add new

sections to the website


updating /Action D.2

Exchange of

documents and

information /Action

D.2

The reserved area (platform) is

currently used and could be

implemented until the end of the

project

Two events

(preparatory

conference and final

conference) organized

and held /Action D.3

YES Not yet.

According to

the timetable

this work will

be done

starting from

October 2015

Layman’s report in

electronic format and

paper copies / Action

D.4

Publishing of

Layman’s report on

the project website

/Action D.4

YES Not yet.

According to

the timetable

this work will

be done

starting from

January 2016

Coordination between

the project and the

Commission /Action

E.1

Coordination of all

project actions

/Action E.1

Smooth and efficient

information flow

between actions;

YES Due to the

nature of

coordination,

this task will

cover the

whole

duration of

the project

The implementation of a Private

area into the website (Platform)

gave the possibility to better

coordinate and monitor the

project implementation, giving

access to useful information.

Operative tasks met in

compliance with

agreed time schedules

/Action E.2

Milestones met in

compliance with time

schedule /Action E.2

Efficient work-flow

among actions /Action

E.2

YES Due to the

nature of the

monitoring,

this task will

cover the

whole

duration of

the project

The partners involved

contributed to the good

development of the project and

contributed to the reporting.


Formal approval of

financial report /

Action E3

Positive approval for

each report / Action

E3

YES To be

approved

The budget has been distributed

according to the original plan to

the ABs. A continuous

monitoring of the expenses has

been conducted. Financial

reports have been prepared for

the Inception Report, Monitoring

visits and the present Mid Term

Report.

Exchange of

documents and

information / Action

E4

YES YES One of communication activities

objectives is to create new

liaison between stakeholders

through the sharing of

competences within networking

activities and the participation to

national and international events.

5.4 Analysis of long-term benefits

5.4.1 Environmental benefits

MED HISS project has widely used dispersion models, required by the Directive 2008/50/CE.

These models are being used for epidemiological purposes, with a procedure using grid values

to have municipality values which takes into account information from monitoring stations.

The assignment of the exposure on the basis of the built-up area provide exposure data closer

to what is currently experienced by population. In this way exposure is refined to a level

where people really live.

MED HISS project will provide evidence on long-term effect and impact of PM2.5, PM10,

NO2, O3 in the Mediterranean area. Estimates will be express in terms of exposure contrast

between categories of pollution. Therefore, future legislation could potentially take into

account output of the project when discussing new threshold levels.

5.4.2 Long-term benefits and sustainability

The results of the MED HISS project may have long term results on the following areas:

- Environment and health. When new policies on air pollution will be evaluated at EU level,

the results from MED HISS project of long term health effect on a European cohort may be

taken into account. The impact of air pollution on population health can be estimated directly

on a European cohort.

- Social. The effects of air pollution tend to be higher for people of lower socioeconomic

position. This is due to greater exposure level as well as higher susceptibility due to more

frequent lifestyle (smoking, physical activity, obesity) in people of lower social class. Any

improvement in environmental pollution will provide a larger benefit to less advantaged

people thus providing more environmental justice.

- Economic. We see no direct economic impact.


- Occupational. Thanks to MED HISS a research group has been set up and can be

consolidated, particularly if this pilot study will be widened to other EU countries, which are

able to set up this surveillance system. Temporary employers are playing a key role in the

overall success of the project. This experience can be consolidated. The participation to ISEE

young in Barcelona permitted to share MED HISS objective with other young researchers.

If MED HISS2 will have future, other employers will be necessary to maintain the

surveillance system that has been set up with MED HISS.

5.4.3 Replicability, demonstration, transferability, cooperation: Potential for technical and

commercial application (transferability reproducibility, economic feasibility, limiting

factors) including cost-effectiveness compared to other solutions, benefits for

stakeholders, drivers and obstacles for transfer, if relevant: market conditions,

pressure from the public, potential degree of geographical dispersion, specific target

group information, high project visibility (eye-catchers), possibility in same and other

sectors on local and EU level, etc.

The project is developing instruments and methods that imply a large applicability and

portability for the evaluation of the long-term effects of environmental exposures. The same

methodology of using data from already existing cohorts from NHISs, followed for mortality

and morbidity outcomes could be employed in future in the same areas to evaluate the

beneficial effects of new policies potentially in all the other EU countries. The key point is

that there should not be legislative impediment to perform this linkage. This low-cost

approach we are setting up could reveal even lower costs if the ecological study will ensure

robust results.

5.4.4 Best Practice lessons: briefly describe the best practice measures used and if any

changes in the followed strategy could lead to possible adjustment of the best

practices;

The first best practice lesson to address to the development of MED HISS is the privacy

regulation, which permits to link data from NHIS’s with deaths and hospital admissions. The

analyses of both individual and ecological studies setup a core of variables to be used as

confounders in this kind of study. Thanks to the networking with DEMETRIQ, this core of

variables covers also other European countries. Moreover, it permits to have a standard which

can be reached also by smaller cohorts (recruited in a different way), which want to follow

back analyses on long-term effects of air pollution.

If ecological analyses will show results which are robust enough, a gold standard of variables

to have at an ecological levels to include in this type of analyses will be produced.

A second best practice is the improvement of dispersion models, integrating them with

monitoring network data, with the use of data-fusion techniques. Moreover, the assignment of

the exposure on the basis of the built-up area is a key point when assigning pollution levels to

population.

5.4.5 Innovation and demonstration value: Describe the level of innovation, demonstration

value added by EU funding at national and international level (including technology,

processes, methods & tools, organisational & co-operational aspects);

The MED HISS project can be considered a pilot study that is estimating long-term effect of

air pollution in Mediterranean area and implementing an ongoing surveillance system in the

participating countries.


It can be seen as a pilot since the final objective of our study is to demonstrate the feasibility

of this new approach and its possible application in other EU member countries. This is

possible thanks to its relative cheapness in comparison to traditional cohort studies

(considering that only the cost of the ACS study in the USA summed up to several million

dollars alone) and its applicability to other European countries.

This can generate, if applied elsewhere, a European surveillance system on the whole EU.

The proposed linkage of national health interview surveys with mortality, morbidity and air

pollution data modelling has a high degree of portability in other EU countries, since that

health interview surveys are performed in every country of the EU and provided that national

institutions may provide health follow-up of individual involved. What is done in this project

on air pollution could be exported also to other thematic areas, like the socio economic one.

The information available in the Health Interview Survey include also many variables on

socio economic side, useful for addressing the issue of Equity.

Problems encountered with privacy policies give the opportunity to test an even cheaper

approach (i.e. ecological study). If at the end of the project it will provide results consistent

with individual study, privacy problems could be overcome also in other EU countries,

providing the possibility to have all potential confounders at least at ecological level.

A second demonstration character is present in the project and is dealing with the pilot study

of feasibility that will be done for simplifying the exposure assessment approach. Air

pollution national dispersion models are very complex, but generally do not consider the

exposure of the population needed for epidemiological purposes. We integrated air pollution

models already available with information from monitoring stations through statistical

methods to get better exposure assessment estimates of the population (action B.1 and B.3),

that can be used also for other contexts and approaches.

A third demonstration character is the possibility of this project to assess the urban- rural

difference of exposure to air pollution and the influence of this difference on risk estimates.

At the moment there is no data on this issue and the project may help to demonstrate it with

the data that will be gathered.

The proposed methodology has a high degree of portability in different EU urban contexts

and the project can be seen as a demonstration that a EU wide assessment (including all EU

countries) can be conducted.

The project development will be monitored by means of specific internal audits and check

lists provided to the beneficiary responsible for the involved actions.

5.4.6 Long term indicators of the project success: describe the quantifiable indicators to be

used in future assessments of the project success, e.g. the conservation status of the

habitats / species.

The results of the MED HISS project may have long term results on the following areas:

- Environment and health. When new policies on air pollution will be evaluated at EU level, the

results from MED HISS project of long term health effect on a European cohort may be taken

into account. The impact of air pollution on population health can be estimated directly on a

European cohort.

- Social. The effects of air pollution tend to be higher for people of lower socioeconomic

position. This is due to greater exposure level as well as higher susceptibility due to more

frequent lifestyle (smoking, physical activity, obesity) in people of lower social class. Any


improvement in environmental pollution will provide a larger benefit to less advantaged

people thus providing more environmental justice.

- Economic. We see no direct economic impact.

- Occupational. Thanks to MED HISS a research group has been set up and can be

consolidated, particularly if this pilot study will be widened to other EU countries, which are

able to set up this surveillance system. Temporary employers are playing a key role in the

overall success of the project. This experience can be consolidated. The participation to ISEE

young in Barcelona permitted to share MED HISS objective with other young researchers.

If MED HISS2 will have future, other employers will be necessary to maintain the

surveillance system that has been set up with MED HISS

Quantitative long-term indicators of the expected project success are reported below, with

reference to the three years after the project end:

• Number of countries which positively reply to the “join our project” survey

• Number of publications achieved after the end of the project

• Number of times the project representatives are invited at conferences, seminars, other

events

• Number of times the map is delivered (if the output will be in a static form) and/or

consulted (if there will be also an on-line version)

• Number of times the MED HISS publications are cited

• Number of times the project results are taken into consideration in policy on

EU/National/local levels

• Number of visits of MED HISS website

• Number of requests for clarifications, update, dissemination and scientific material

(publications, Layman’s report, etc.)


6. Comments on the financial report "Standard Payment Request and Beneficiary's Certificate" - duly signed original has been

submitted (Annex 31). "Consolidated Cost Statement for the Project" - signed original has

been submitted (Annex 30). "Financial Statement of the Individual Beneficiary" signed,

originals have been submitted by the coordinating beneficiary and by each associated

beneficiary (Annex 29).

Consolidated Cost Statement for the Project has been shared with all the ABs and have

been calculated using the financial data that were uploaded on the Platform for the Mid

Term Report purposes. During the months of February 2015 and March 2015 we had

frequent contacts with all ABs in order to check each data of each reporting file to be

signed. Individual financial French data here enclosed (that are the signed and dated forms

we received on last day) are slightly higher than those already reported in the Consolidated

Cost Statement for the Project, already signed by our Director Ing. Angelo Robotto.

Supporting documents, and further information or clarifications, requested in previous

letters from the Commission (e.g. VAT declarations.) have been submitted: Annex 21, 22,

23a, 23b, 24.

6.1. Summary of Costs Incurred

The following table refers to the project costs from 01/07/2013 to 31/01/2015: they represent

the costs linked to the activities conducted during 19 of 36 months.

PROJECT COSTS INCURRED

Cost category Budget according to the

grant agreement*

Costs incurred within

the project duration

%**

1. Personnel € 1.308.815 € 547.189 42%

2. Travel € 56.000 € 17.418 31%

3. External assistance € 62.500 € 29.880 48%

4. Durables: total non-

depreciated cost € 33.400 € 21.323 64%

- Infrastructure sub-

tot. € 0

- Equipment sub-tot. € 0

- Prototypes sub-tot. € 0

5. Consumables € 22.600 € 4.264 19%

6. Other costs € 11.500 € 159 1%

7. Overheads € 103.468 € 42.465 41%

TOTAL € 1.598.283 € 662.698 41% *) If the Commission has officially approved a budget modification indicate the breakdown of the revised budget

Otherwise this should be the budget in the original grant agreement.

**) Calculate the percentages by budget lines: e.g. the % of the budgeted personnel costs that were actually

incurred


The original grant agreement foreseen a Total of 1.598.283 Euro taking into account the not

depreciated costs for the durables goods.

Overall, effective costs were about the 40% of the total projected costs. The project has

arrived to the 19th

month of 36: about 53% of its implementation.

Some actions are still to come, mainly C and D, with related costs. We provided in

“Consumables” all the costs useful to the organization of Dissemination conferences, that are

still to come. We provided in “Other costs” the budget to attend the ISEE 2015 Conference

and to print the Layman’s Report. This expensed are related to activities that haven’t been yet

undergone.

Comments for specific budget categories:

− Personnel: as mentioned in the Inception Report, a delay occurred in the starting

months of the project; this fact had slightly affected this cost item. The budget of the

project allowed the provision of temporary contracts both for CB and ABs: by now we

have balanced expenses for permanent staff and for temporary staff (on average, we

spent 41% of the budget devoted to permanent staff, and 43% devoted to temporary

staff). Some differences among ABs are attributable to the role played in the project

and to the involvement in the different Actions, as well as to a certain delay in the

starting of the project.

We are aware that the daily rates reported in the e_proposal for ARPAP were

understated, for each public employee. In the Inception Report we provided

documentation on that. Now the estimates of the daily rates are more robust, due to the

number of months used for the calculation.

We are monitoring this problem using an automatic file that updates the summary

financial info on the basis of the data uploaded in the financial statement file, in order

to view the current daily rate for each person, for each year, at each instant of the

project.

However, we can state that the costs now reported are the real costs for personnel

employed in ARPAP, which has the same National Contract of organizations

belonging to National Health Service. We have already reported these costs in other

funded projects, given that the daily rates were online with the ones reported from

other Partners, belonging to other organizations of National Health Service.

− Travel and subsistence: up to now, four meetings have been held, in Turin, Paris,

Bologna and Barcelona. The costs reported to attend the meetings were, in general,

lower than foreseen. The Mid Term Meeting in Barcelona was very important to

finalize the activities on going and also for the Mid Term Reporting and so we had a

good participation. Moreover, most of the meetings are foreseen for future, namely: 1.

Fourth action meeting in Ljubiana; 2. Participation to international conference in

2015; 3. Preparatory meeting for final conference in Barcelona; 4. Dissemination

national conference; 5. Final conference. In all these events, an extensive participation

is foreseen. For this reason, even though the incurred costs up to March 2015 are

relatively low compared with the total costs, the projected costs have not changed in

the present report.

− External assistance: only two partners had a budget for External assistance: ARPAP

spent the budget for the Web page development and CREAL used a portion of the

budget to finalize Action B1 Activities. The remaining necessity foreseen are still

valid.


− Durables goods: ARPAP, CREAL and ENEA spent a portion of their budget to

acquire the informatics equipment necessary to the project. If additional needs will

arise, the Consortium will evaluate how to manage them. The depreciation calculating

methods are reported in the Annex 21.

− Consumables and Other costs: only a small amount of funding has been spent so far

for this category, in line with the general comment above mentioned.

As a general comment, we believe we are in line with what was scheduled in the original

proposal, as breakdown of budget posts. The current report covers about an half of the

entire project (from 01/07/2013 to 31/01/2015, 19 out of 36 months), and given the

explanations provided above, we expect to have total costs equal to the previewed ones,

with no need for substantial changes in the budget requested to the EC. Maybe small

changes will be necessary with the progressing of the project, especially little shifts of

costs from one cost category to another, but it is not feasible to report them in the present

report. Finally, the 150% threshold (expenditure of the first pre financing already

received) has been reached.

6.2. Accounting system

In order to put in place an accounting system for the project, we started from the

administration procedures used by each ABs. The public partners turned out to have a

dedicated cost centre accounting system for traceability of expenditure and income of the

project (Annex 22- Accounting system). In addition, we are using the costs accounting system

based on the MS-Excel file published under the project tools section of LIFE+ website. Each

AB is responsible for the compilation of the financial form. The files are uploaded on the

mentioned Platform (Private area of the website) about every quarter. After the review of the

CB, the MS-Excel files are summed up to produce the total costs of the project.

During each review the CB had to verify/will verify:

- person-time reported into financial statement (sheet “Personnel”) according to time sheets

and according to technical activities;

- costs covered by invoices correctly reported in the file (number of invoices, date);

- invoices reporting the name of the project and the code Life LIFE12 ENV/IT/000834;

- stamp on the invoices/sheets with the name of the project and the code Life LIFE12

ENV/IT/000834;

- an estimate of the overheads correctly reported;

- costs already covered by the budget, otherwise we should ask for an advice to the

monitoring team/the FDO;

- methods to estimate the depreciation, if necessary.

At the same time, taking into account the Financial check list currently used for the project

(Annex 26 - Updated Financial check list), the CB should give advice about the

documents/file/declaration needed and linked to the expenses reported, to be storage.

During each meeting a time was devoted to these aspects and to collect from the ABs the

documents eventually needed.


Each AB filled in time sheets according to LIFE+ rules. We have already enclosed some time

sheet to the Inception Report. Each AB briefly described the time recording system used, as

shown in the Annex 23a - Time registration system and Annex 23b. The same in case of

durables (informatics equipment) (Annex 21 - Depreciation calculation).

Each Partner gave us the VAT declaration, where relevant for the reporting financial data

(Annex 24 - VAT declaration).


6.3. Partnership arrangements (if relevant)

Above mentioned the method

6.4. Auditor's report/declaration

We are currently contracting the external financial audit, as requested in the terms of the

Mid Term Report:

Massimo Lucii

STUDIO LUCII

Via Sarzanello n. 226

19038, Sarzana (SP), Italia

6.5 Summary of costs per action


Action

no. Short name of action

1.

Personnel

2.

Travel and

subsistence

3.

External

assistance

4.a

Infra-

structure

4.b

Equipment

*

4.c

Prototype

5.

Purchase or

lease of land

6.

Consumables

7.

Other costs

TOTAL

B1 Pollutant data mapping € 191.438 € 1.903 € 20.000 € 19.760 € 243 € 233.344

B2

Survey and health data collection € 158.438 € 4.507 € 1.563 € 703 € 165.210

B3 Pooling country specific data € 30.599 € 8.200 € 1.526 € 40.325

B4

Development of the statistical modelling strategy for the analysis

€ 21.359 € 5.000 € 26.359

B5

Health effects of air pollutant on total and cause-specific mortality

€ 1.450 € 1.450

B6

Health effects of air pollutant on total and cause-specific hospitalizations

€ 1.450 € 1.450

B7 Health impact assessment € 7.359 € 7.359

C1

Monitoring of the impact of the project € 4.059 € 4.059

C2

Assess the socio-economic impact of the project actions € 579 € 579

D1

Dissemination to policy and decision makers and to the public

€ 25.599 € 39 € 25.638

D2

Web design, development and results displaying € 17.059 € 4.880 € 159 € 22.098

D3

Conference spanning the topics of the project € 0

D4

Layman's report developing for dissemination € 0

E1

Co-ordination and management € 32.500 € 186 € 32.686

E2 Monitoring of the project € 19.850 € 2.622 € 1.753 € 24.226

E3 Administration of budget € 25.399 € 25.399

E4 Networking with other projects € 10.049 € 10.049

TOT € 547.189 € 17.418 € 29.880 € 0 € 21.323 € 0 € 0 € 4.264 € 159

Over-

heads € 42.465

TOTAL € 547.189 € 17.418 € 29.880 € 0 * € 21.323 € 0 € 0 € 4.264 € 159 € 662.698

*Equipment: non-depreciated costs


Some comments:

We spent about all the budget foreseen for the B1 and B2 Action, according to the Gantt

Chart (92% and 86% respectively). Action B3 and B4 are ongoing whereas B5 and B6 have

just started. We provided a draft protocol for Action B7.

Not all C and D Actions are on going by now, according to the Gantt Chart. In particular the

main activities to provide a website and a Platform (Private area) for the project have been

implemented.

We already consumed the 103%, 121% and 115% of E1, E2 and E3 foreseen costs; it is

worthy of note that E Actions costs includes K.O. meeting organisation costs in Turin, the

travel and subsistence costs correlated, the time spent to implement a system to control for the

managing of the budget, and to check the availability of administrative/financial data form the

ABs. Most of the E2 activities were undertaken from the ARPAP staff, with time spent and

correlated costs (higher costs than foreseen, according to higher daily rates reported now

compared with the costs estimated for the e_proposal, as already mentioned).

We had to use a lot of these costs to finalize the reporting for the present Report: we can state

that by now all the activities related to E Actions have been fully implemented.

We already consumed the 58% of the budget provided for E4 action.

Travel and subsistence costs and Consumable costs related to the meetings (for B1, B2 and

B3 Actions) were generally lower than prevented.


7. Annexes The text of this report is completed by 39 annexes organized in the following three areas:

administrative, technical and dissemination.

7.1 Administrative annexes The administrative documents are:

-Annex 1- GANTT

-Annex 2- Partnership Agreement NIJZ

-Annex 3- Monitoring reports

-Annex 4- Letter of the European Commission 2015

- Annex 21 - Depreciation calculation

- Annex 22 - Accounting system

- Annex 23a - Time registration system

- Annex 23b - Time registration system ENEA

- Annex 24 - VAT declarations

- Annex 26- Updated Financial check list

- Annex 29 -Financial Statement of the Individual Beneficiaries

- Annex 30 - Consolidated Cost Statement for the Project

- Annex 31 - Standard Payment Request and Beneficiary's Certificate

Administrative annexes already included in the Inception Report are:

- Annex C - Monitoring protocol of the project

- Annex D - Monitoring report of the project

7.2 Technical annexes The technical documents are:

-Annex 5- Descriptive statistics on pollutant data collected

-Annex 6- Exposure assessment study

-Annex 7- Statistical protocol (draft)

-Annex 8- Preliminary results PM2.5 year 2005 Italy

-Annex 9- Individual approach: data available and health endpoints

-Annex 10- Ecological approach: health endpoints

- Annex 11- List useful for literature review

- Annex 12- HIA protocol (draft)

- Annex 16- Interactive map ideas

- Annex 25- Minutes of the meetings

- Annex 27 - Minutes of the Steering Committee meetings

Technical documents already included in the Inception Report are:

- Annex A- Air pollution mapping protocol

- Annex B - Survey and health data protocol

7.3 Dissemination annexes The documents related to communication and dissemination are:

- Annex 13- STAKEHOLDERS map


-Annex 14- Targeted mailing lists

-Annex 15- Newsletter n.1_draft

-Annex 17- Photo Barcelona meeting and PART’AERA networking

-Annex 18- Press cuttings

-Annex 19- ISEE 2014 poster

-Annex 20- Abstract ISEE 2015

- Annex 28- STAKEHOLDERS strategy_draft

Dissemination annexes already included in the Inception Report are:

- Annex E - Stakeholders mailing list

- Annex F - Epidemiological evidences to support EU policy

- Annex G - Photos_notice board

7.4 Final table of indicators -Annex 32-. Outcome indicators tables


_________________________________________________________________

8. Financial report and annexes

- "Standard Payment Request and Beneficiary's Certificate" - duly signed original has

been submitted (Annex 31).

- "Consolidated Cost Statement for the Project" - signed original has been submitted

(Annex 30).

- "Financial Statement of the Individual Beneficiary" signed, originals have been

submitted by the coordinating beneficiary and by each associated beneficiary (Annex

29).

- Supporting documents, and further information or clarifications, requested in previous

letters from the Commission (e.g. VAT declarations.) have been submitted: Annex 21,

22, 23a, 23b, 24.

For detailed guidance on preparation of the financial report and annexes we referred to

the financial management guidance document available on the following website:

http://ec.europa.eu/environment/life/toolkit/pmtools/index.htm

shared and commented with the ABs.

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