DG-SANCO European Commission

Health and Consumer Protection Directorate-General

PROJECT N°: 2004129 ACRONYM: BIRO TITLE: Best Information through Regional Outcomes

Second Technical Implementation Report

Period covered: 01/12/2006-30/1/2008

Author: Prof. Massimo Massi Benedetti Organisation: University of Perugia Start date of the project : 01/12/2005 Duration: 36 months Dissemination: 30/01/2008 Document Number: 01 Version: 01 Date of preparation: 30/01/2008

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Scientific/Financial co-ordinator

Name: Prof. Massimo Massi Benedetti Address: Department of Internal Medicine

University of Perugia Via Enrico dal Pozzo 06126 Perugia (I)

Phone Numbers: +39 075 5727627 Fax Numbers: +39 075 5727627 E-mail: massi@unipg.it

Project websites: www.biro-project.eu Project e-mail address: biroeu@unipg.it

Signature Scientific Co-ordinator: ____________________________________________

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Executive Summary

The main objective of the BIRO project is to build a European infrastructure for standardized data

exchange that will regularly monitor, update and disseminate evidence on the level of application of clinical guidelines and the relative outcomes achieved in diabetes at the continental level.

To fulfil our goal, we have proposed an innovative workplan characterized by the following features: 1) theoretically based on a statistical approach linking multiple sources of information; 2) designed to exploit resources already available at the regional level; 3) using low cost, advanced software solutions to deliver automated outcome reports The main objective has been pursued through the realization of specific tasks, allocated to separate

WPs, that have been successfully accomplished during the first 26 months (December 2005-January 2008):

o identification of target parameters/indicators extracted from the scientific literature (WP2). o specification of a European minimum dataset (WP3) o identification of a shared concept/data dictionary (WP4) o definition of agreed criteria for privacy protection (WP5) o definition of a common standard for routine monitoring (WP7) o development a relational data model (WP6) o identification of a secure protocol for international communication (WP9) o coordination, management and evaluation (WP1, WP13, WP15)

So far, the project has delivered all 13 products planned for the period. The Consortium met in seven different occasions, in five different countries, including two major

“Annual Investigators’ Meetings” held in New Member States, i.e. Malta and Cyprus. Independent experts have been involved in project evaluation. As far as dissemination is concerned, abstracts have been presented at the IDF world meeting in

2006, the National Romanian Diabetes Meeting in 2007, and Diabetes UK 2008. The Consortium has also contributed to the SANCO report on Major and Chronic Diseases 2008. Three issues of the BIRO newsletter were released. The B.I.R.O. website (www.biro-project.eu) has been regularly maintained, with a repository organized in the two major areas of public/restricted access. A forum has been organized to store and exchange material that can be submitted by registered members.

During the final part of the project, the Consortium is expected to deliver the 17 deliverables in the

following areas: o standardized statistical software to deliver outcome results (WP8,WP10) o a detailed plan for BIRO technology transfer in new participating regions (WP12) o dissemination of all results through a web portal and a range of publications (WP11,WP14)

Deviations from plan or other problems

with contractual consequences

o So far (month 26), no major deviations from the original plan or other problems with

contractual consequences have been noticed.

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MAIN ACHIEVEMENTS

The BIRO project workplan develops around four major thematic areas:

a) coordination (WP1, WP12, WP13, WP15); b) data model and data flow (WP2, WP3, WP4, WP5, WP6, WP9); c) statistical analysis (WP8, WP10); d) outputs delivery (WP7,WP11,WP14);

At the outset, a total of 30 deliverables were planned, mostly concentrated in the last part of the

project (N=17). At month 26, the project has delivered all 13 products planned for the period (see table 1).

As far as “coordination” is concerned, the Consortium has achieved the following:

1. “1st Progress Report” (WP1): The Coordinating Centre has successfully delivered the 1st Executive and Technical Implementation Reports to the European Commission at the end of 2006. DG-SANCO has positively evaluated the Consortium achievements.

2. “1st Evaluation Report” (WP15): At the end of the first year international clinical experts have been involved as independent evaluators to provide valuable advise on the following aspects: completeness of the clinical review, ability of information included in the common dataset to monitor diabetes in all its components, effectiveness of the dissemination strategy. Comments on project deliverables have been compiled in a short report that has been discussed in detail directly with our experts at the 2nd Investigator Meeting, held in Cyprus 23-26 May 2007.

3. “2nt Progress Report” (WP1): The Coordinating Centre has successfully delivered the 2nd Executive and Technical Implementation Reports to the European Commission at the end of January 2008.

4. “2nd Evaluation Report” (WP15): Interim Evaluation Report has been delivered at the end of 2nd year, summarizing the main comments made by evaluators. More details will be included in an update that will be produced in 2008.

For the “data model and data flow”, the project has finalised the following:

1. “Clinical Review” (WP2): a systematic review of the scientific literature identifying all basic data components for the development of BIRO. The report provides an up-to-date definition of all data items and a shortlist of target indicators split by categories: Epidemiology, Structural Quality, Process Quality, Intermediate and Terminal Outcomes

2. “Common dataset” (WP3): structure of a common dataset that can be rapidly extracted by all members of the Consortium to feed the statistical engine. The standard has been identified through the review of diabetes database systems in place in participating regions. Precise specifications link each data item to clear definition of clinical measurements, intermediate and terminal outcomes at the individual level, and characteristics of the health system e.g. service providers and the population served in the catchment area.

3. “Data dictionary” (WP4): Basic and derived data components e.g. those identified by cutoffs on continuous variables (ex: high/intermediate/low level of HbA1c) have been compiled into a common data dictionary that serves as a reference for the entire BIRO diabetes data model. The structure of the Data Dictionary, based on international standards, adds flexibility to the dataset, allowing continuous updating until the end of the project, and beyond.

4. “XML Schema” (WP4): Automation of the use of both the common dataset and entire data dictionary is guaranteed through the specification of an ad hoc XML Schema. The "BIRO data exchange format" will be used by each participating partner to export and submit validated data to the statistical engine.

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5. “Privacy Impact Assessment” (WP5): A review of the literature on privacy protection in relation

to the adoption of BIRO has determined the following legal implications: 1) use within a single region complies with both national and European directives; 2) data exchange at the international level may be hampered by inappropriate definition of the overall architecture. A modified Delphi panel has been set up to identify the best architecture among three candidate ones previously outlined by a dedicated team. Results highlighted the following structure: a) records aggregated by group of patients; b) stratification by service centre and/or multidimensional patterns allowed; c) date fields approximated to months; d) measurements averaged over time; e) pseudonym used for service centres; f) data transmission prompted by authorized administrators of local registers; g) central database of aggregated data and web portal maintained by the Coordinating Centre.

6. “Database Engine” (WP5): specialised software to automate data transfer from the BIRO XML schema to the BIRO database, including all specifications provided by the Data Dictionary. A storing process was implemented, composed of four consecutive steps: creation of a java object model from the XML schema; generation of DDL from the java object model; creation of java objects from XML document; mapping of java objects into database records. Ad hoc developed software includes an original “Adaptor” that the Consortium will adopt to connect any DBMS to the BIRO database.

7. “Communication Software” (WP9): software based on web services was specifically developed to allow for aggregate data tables computed by single registers to be transmitted to the BIRO central server. A service was implemented, based on the Apache Axis framework, which provides submission of any files. Results of the Privacy Impact Assessment were duly taken into account. Security was established in two layers. Firstly, on the communication layer, the entire communication is encrypted and authentication can be enforced via the HTTPS protocol. Secondly, the payload of the SOAP message is encrypted and signed, so that security features persists also after the transmission over the network. The Apache Rampart framework was used and configured to establish encryption and digital signatures.

Deliverables of the “statistical analysis ” have been all planned for the last part of the project and so

there is currently no report available. Nevertheless, the Statistical Engine is under advanced development and is currently able to deliver a simplified version of the target reports for each register.

A complete example of the combined use of the database and statistical engines has been presented at the last Rome meeting in December 2007. Routines from the statistical engine are being translated in the equivalent procedures required for the automation of the central engine (i.e. combination of results from different registers).

In terms of “outputs delivery”, the project has produced the following:

1. the “Reports Template”: a common structure for diabetes reports that can be automatically generated by BIRO, identified on the basis of the actual feasibility of computation. Selected outputs are now based on data items currently collected by participating centers. The report, providing full specification of tabular and graphical outputs, represents the main reference for the application of statistical procedures.

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To ensure tight connection between the different WPs, the Consortium has developed its products by strengthening mutual interaction through the organization of periodic meetings.

Each meeting identified a leading theme, focusing on the development of the relevant step foreseen

in the workplan:

1. BIRO Kickoff Meeting, “Revising the BIRO workplan” Perugia , Italy, 5th December 2005

2. 1st Technical meeting: “Bridging the diabetes information gap”, Dundee, Scotland, 6th-7th March 2006

3. 1st Annual BIRO Investigators’ Meeting, “Identifying the BIRO users” St.Julian, Malta, 30th September- 2nd June 2006

4. 2nd Technical meeting, “Sketching out BIRO architectures”, Graz, Austria, 29-30th September 2006

5. 3rd Technical meeting, “From research to implementation: the way forward”, Dundee, Scotland, 26-27th March 2007

6. 2nd Annual BIRO Investigators’ Meeting, “Specifying the best architecture” Larnaca, Cyprus, 23-26th May 2007

7. 4th Technical Meeting, “Towards the first release of the BIRO Prototype” Rome, Italy, 3rd December 2007

In terms of publications, abstracts have been accepted and presented at the IDF world meeting in

2006, the National Romanian Diabetes Meeting in 2007, and Diabetes UK 2008. The Consortium has also contributed to the SANCO report on Major and Chronic Diseases 2008 with a chapter on diabetes, in collaboration with F.Storms from CBO.

A newsletter has been periodically released with three issues published so far. All material is available at the B.I.R.O. website (www.biro-project.eu), a repository organized in the two major areas of public/restricted access. A forum has been organized to store and exchange material that can be submitted by registered members.

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1 – Overview

1.1. Work Packages

Objectives Progress towards achieving objectives WP1. Coordination (M1-M36)

Aim of this WP, led by UNIPG, is to ensure that all members of the Consortium and the associated bodies receive strong and timely support to perform all duties planned in the project.

The main reference point for the BIRO project is the BIRO Coordinating Centre at the University of Perugia (BCC), organized by the Project Coordination Board (PCB) composed of the Scientific/Technical Co-ordinators, Administration Officer and the Project Manager.

During the period covered by the present report, the PCB has: o acted as a prime point of contact between the Commission and the

Consortium o distributed financial support to the partners as agreed with the

Commission. o helped partners to finalize all the administrative documents (time sheets,

budget, list of invoices) and monitor the correctness of documents to be sent to the EU Commission

o organized and provided logistical support for the 7 main project meetings held in different locations (agenda, minutes, presentations, multimedia and additional information available in the restricted area of the BIRO website)

o monitored the content and progress of each WP o maintained an updated agenda on the progress of the project o ensured regular communication between partners, and proper redirection

in case of deviations from plan. o promptly collected all project deliverables, prioritizing material for the EU

Commission o disseminated results, through the BIRO Web Site, the BIRO forum, the

BIRO Brochure and by participating to major meetings and conferences (Task Force on Major and Chronic Diseases, Luxembourg, December 2006, 19th World Diabetes Congress of the International Diabetes Federation, Cape Town, December 2006, the European Health Forum, Gastein, October 2006/2007)

o organized and maintained all web communication o chaired all Kickoff, Technical and Annual meetings, anticipated by the

preparation of the agenda, and followed by the publication of project minutes.

o coordinated the editorial activities Staff interactions continue to follow the original structure defined in the revised

workplan, with some changes in the personnel involved (see Figure 1). In September 2007 the former Project Manager (PM) Marco Orsini Federici was replaced by Valentina Baglioni. She is now simultaneously covering the roles of PM, Database Administrator and Software Developer.

Coordination of meetings allowed reaching fundamental agreements e.g. an early definition of the BIRO architecture (Fig.2).

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Figure 1 – Human Resources Information Flow Chart

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ID

123

456

XML

DATA DICTIONARY (Data Items, Indicators)

WP6

DB

Completeness, Bias

DW

SOURCE DATA

LOCAL

Patterns

“Statistical

Objects”

SOReport

Template WP9

STAT

WP8

XML

WP1

Report

Template WEB

SEDIS

Figure 2 - BIRO Architecture and Software Requirements

WP7

WP1

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WP2. Clinical Review (M1 - M32)

Aim of this work package, led by Joanneum, is to identify a core set of validated parameters and indicators that can be used to drive the construction of the BIRO infrastructure.

Outputs of WP2 provide direct input to the Common Dataset (WP3), the Data Dictionary (WP4), and the Reports Template (WP7).

The main task of this WP is to produce the first deliverable D2.1, “Clinical review”, delivered at M8 (see:

http://www.biro-project.eu/documents/downloads/Clinical%20Review.pdf) The report, through a comprehensive review of diabetes indicators, defines the

core list of measures that can be routinely produced using a common BIRO dataset (see Figure 3).

The deliverable is the result of the collaboration between the WP leader, Joanneum, all BIRO partners, and high level independent evaluators F.Storms (CBO, Netherlands) and A.Adler (University of Oxford and Cambridge, UK) engaged by the leader of WP15 (University of Malta).

Dedicated sessions held at the Malta and the Cyprus meetings allowed to discuss the initial draft report and to review the content of the final version, based upon the structure of the BIRO dataset already identified.

Proposed changes are scheduled to be included in D2.2, expected in August 2008.

After its publication, the clinical review has been extensively used for the preparation of the reports template that will specify the content of all BIRO statistical reports (WP7, D7.1).

Figure 3 – Indicators short list from clinical review

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WP3. Minimum Dataset (M1 – M12)

Aim of WP3, led by UNIDUND, is to define a minimum data set that can be used as a common reference for the extraction of standardized measures that will be adopted at the European level.

The WP foresees only one deliverable at M12, D3.1 “Common dataset”, delivered at M13 (see:

http://www.biro-project.eu/documents/downloads/Common%20Dataset.pdf) The WP leader involved researchers from each partner institution to produce

the report. During the first months of work, all partners agreed to collect the format used

by the separate diabetes registers and the detailed list of clinical definitions associated with each item. The WP leader reviewed the structure of all datasets and provided a first commentary of the separate formats that has been discussed by all partners.

The objective of this exercise was to identify consistencies and inconsistencies with the recording of data items and to create a universal definition for each of the items in the dataset. Definitions of data items have been compared in order to create a standard definition that could be retained as globally acceptable.

To the best of our knowledge, this is the first time that such a meta-dataset has been specified in detail at the European level.

The BIRO common dataset appears to be a product of specifications independently provided by previous studies and different organizations, e.g. Diabcare, the Forum for Quality Systems in Diabetes Care (FQSD), the Scottish Diabetes Core Dataset, the Umbria Diabetes Register (PROMODR), EUropean Core Indicators in Diabetes (EUCID), the Australian Diabetes, Obesity and Lifestyle (AusDiab). Whenever possible, the International System of Units (SI) definitions have been applied to parameters recorded with inconsistent units of measurement across different datasets.

To overcome some of the possible flaws arising from a minimum dataset, additional items were added to increase comparability across systems of care and correspondence with the most recent literature.

In the report, each item in the BIRO dataset is classified as either a “clinical parameter” or a “clinical site parameter” (see Figure 3).

Items include patient data e.g. HbA1c, Clinic last attended, Patient’s GP Practice, or descriptions of clinical sites e.g. Clinic Population, Catchment Area Population and Specific Guidelines Used.

Each item is given a unique reference code along with a field name consistently used in the BIRO database. Data types are clearly specified for each measure. Definitions and accurate coding criteria are clearly specified to allow unambiguous data standardization. Any mandatory fields are clearly indicated.

A “data mapping” specification is also included to translate local data into a common standard BIRO Dataset, in order to avoid any mismatches in the units of measurement or different definitions used by different registers.

Some data items show that similar concepts do not always translate in identical definitions and not infrequently slight variations are present: for such reason the Consortium has introduced the concept of “validity”, so that items for which comparisons may not have a complete correlation are clearly highlighted.

Clearly, the Common Dataset must be seen as a dynamic document that will naturally evolve with continuous updating for the entire duration of the project, and beyond. A new version of the Common Dataset has been already introduced following the many changes proposed by the external evaluators at the 2nd BIRO investigators’ meeting (Cyprus, 23rd -26th May 2007).

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Figure 4 – Definition of a parameter included in the Common Dataset

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WP4. Data Dictionary (M1 – M32)

The University of Dundee (UNIDUND) is leader of the WP, involving all partners. Aim of the Work Package is to create an electronic directory inclusive of concept and data dictionaries allowing to dynamically linking the clinical knowledge-base to the systematic evaluation of health systems outcomes.

This electronic dictionary will tie in closely with the clinical indicators developed in Work Package 2 and the minimum common dataset defined in Work Package 3. WP4 defines the structure of a relational database towards which any register may map own data. Clinical experts were involved in the qualitative analysis of the linked datasets to ensure that appropriate data mappings and proper standards were identified.

The joint development of data dictionary and data standards can be paramount for the improvement of quality, relevance, consistency, availability and comparability of national health information. In fact, as data is shared then one needs to ensure that all of those who need to use the data can clearly understand the meaning, regardless of how the data is collected or stored at each source. This is imperative for the BIRO model as data will be collected across seven European partner sites.

During the first two years of the project the WP focused on the delivery of D4.1 “Data Dictionary” and D4.2 “XML Metadata Dictionary”. The reports defined the key items, the overall structure of the repository, and how items will be stored in the central BIRO repository,

The Data Dictionary can be logically divided in three components. o “Clinical Definitions”, consisting in the detailed description of relevant

metadata. Metadata is the definition or structured description of the content, quality, condition or other characteristics of the data. Metadata leads to better data and subsequent analysis because it enables those collecting, using and exchanging data to share the same meaning and common representation.

o “Data Export”, defines the structure of individual data required from each partner wishing to join the collaborative data exchange network. The data extract is defined with profile data that is recorded only once, separately from clinical results that may be recorded several times

o the “Data Source Export” component defines the structure for profile of the clinical site providing the patient data extract.

In addition, the Data Dictionary also contains: o “Data item mapping”: this section details the precise mappings required to

derive standard BIRO data items from non-standard units. As a matter of fact, some systems contributing to the BIRO data analysis store clinical data in a format that is inconsistent with the BIRO dataset. In most cases, it is possible to map from the source data format to the BIRO format.

o “Indicator Calculations”: BIRO WP3 describes data items required to compute each indicator by specifying numerators and denominators. This section includes pseudo code to assist rapid estimation.

o “Quality of Data Item Assessment”: addresses the comparability of data across all BIRO partners. This section covers the data that must be gathered to meet this requirement. For each item in the BIRO dataset, each partner will be required to assess its quality in comparison with the agreed definitions. This assessment exercise must detail consistency with the BIRO definition, completeness (are data available for all diagnosed patients?) and an overall quality score (a value judgement on the ability for the data source to provide complete and consistent data in line with the definition).

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2006 activities and results XML metadata representation was presented as a basis for the data dictionary

at the Graz Meeting. The discussion concentrated on the need for a clear and unambiguous description of clinical items, to overcome what seems to be a common weakness of disease registers, i.e. the lack of general standards. As a starting point, it was suggested to comply with the data definitions adopted by the Scottish National Service.

Following this meeting, a refined XML metadata dictionary was produced. After an in depth analysis of the revised document, the Consortium agreed that a soft partition of the categories (like yes, no, partially), however simplistic, might be more appropriate for items such as retinopathy, where very different definitions exist between the different regions involved. As a result, the WP produced a first draft of the “D4.1. Data dictionary” report.

2007 activities and results The Consortium presented a draft of the BIRO XML schema at the Dundee

Technical Meeting (26-27 March 2007). Partners underlined that the schema should be expanded to include other clinical areas and/or administrative data. The Consortium noticed that problems would arise with an exchange of personal data e.g. centres’ ids, etc. The problem would be greater if this was perceived as a privacy-threatening issue even at the level of the single professional.

Updated versions of the data dictionary and XML Schema were provided at the 2nd BIRO investigators’ meeting (Cyprus, 23rd -26th May 2007), where the updated content of the data dictionary and XML schema were presented (see Figure 5).

The three major components of the schema being highlighted included: o ECClinicalDefinitions, containing description of clinical items, maps to

indicators and algorithms to calculate indicators; o ECDataSourceExtractDefinition containing the essential data source

profile for the generation of clinical relevant indicators o ECDataExtractDefinition describing the structure of BIRO XML file that

partners should use as a reference to populate the BIRO dataset Changes proposed by external evaluators were discussed in detail. Partners agreed to fill in a questionnaire reporting more information on the

characteristic of individual clinical centres involved. Both reports were revised during summer 2007 and their final versions were

made available on October 2007.

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Figure 5. Extract from XML Data Dictionary

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WP5. Privacy Impact Assessment (M1 – M32)

WP5 aims at strengthening procedures related to the protection of privacy and confidentiality within the BIRO information system, and to establish it as a gold standard for diabetes information exchange across the EU, fully compliant with current national and international regulations.

The WP, led by UNIPG, involved clinical experts from all sites, coordinated by the subcontracting company "Serectrix".

2006 activities and results The WP facilitator produced an operational document describing the series of

steps for the progressive refinement of the BIRO architecture, based on a set of privacy related criteria. The document outlined activities planned for Phase 1 of WP5, set to end in December 2006. According to the plan, the Consortium performed a targeted literature review to identify the main criteria for the definition of a privacy-compliant BIRO architecture. Core articles along with the relevant legislation have been identified and distributed to all partners in electronic format. A “PIA” Team was created including one representative from each partner institution. The PIA team reviewed selected material and identified a checklist composed of all key privacy requirements.

The PIA team identified three candidate alternative architectures for data protection:

o Individual Patients, De-identified (Pseudonym), an architecture requiring the specification of a secure PID encryption algorithm and privacy protective technology for data transfer

o Aggregation by group of patients, Centre ID Available (De-identified), requiring the definition of a secure encryption algorithm for each Centre ID, and privacy protective technology for data transfer

o Aggregation by region, which requires the specification of algorithms to optimise data aggregation while impeding reverse engineering, and the use of a privacy protective technology for data transfer

The possible data flow standard, and the nature of personal information to be transmitted have been identified at the Graz meeting as a reference for the PIA architecture.

Step 1 of the PIA process was finalised through the production of Deliverable D5.1: "Preliminary Privacy Impact Assessment”.

2007 activities and results In 2007 the Consortium undertook the second phase of the Privacy Impact

Assessment and Data Flow Analysis. The general objective of PIA Step 2 was to describe and to analyse the information flow occurring through the BIRO system in order to ultimately identify the best privacy protective BIRO architecture. Specific objectives were to develop a detailed description and analysis of BIRO data flow, to describe the different alternatives selected in PIA Step 1, to identify the best privacy enhancing system architecture for BIRO through a ranking exercise performed by a Delphi Panel. The panel included all members of the PIA team (already selected by BIRO partners).

At the Dundee BIRO technical meeting (26-27 March 2007) the facilitator introduced use of the Delphi Method. A “Data Flow Table” has been produced to collect all technical aspects and possible alternatives that should have been considered for each candidate alternative. Many of these aspects are related to the application of data linkage. For instance, data transfer may involve sending aggregated tables by centre, but this in many cases may imply the identification of the clinical centre, which in turn may have an impact on the professionals involved. Other options may involve more technical aspects e.g. retention site, automation of data transmission, etc.

The Data Flow Table includes all basic elements required to define a

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questionnaire. Each alternative includes a list of aspects/options that must be scored based on different criteria.

The WP leader provided a questionnaire to the panel few weeks before the 2nd BIRO investigators’ meeting (Cyprus, 23rd -26th May 2007). The panel filled the questionnaire providing marks independently from each other as a result of their examination of the Data Flow Table. All questionnaires were collected and examined by the WP leader.

At the Cyprus Meeting the WP leader coordinated a session where final marks were given, for each of the following dimensions: privacy protection, information content, technical complexity . Main criteria to score privacy included identifiability, linkability and observability. A privacy axis (metrics) was defined, spanning from anonymity, to non-reversible /reversible pseudonimity and verinimity.

Final ranking of the different alternatives was produced by weighting criteria and selecting the best architecture through a Consensus Panel. Scores were collected for the final PIA report (each panelist’s scores made anonymous).

The best architecture was the one entitled “Aggregation by Group of Patients” (see Figure 6), which is characterized by the following:

o data is exchanged only aggregated by group of patients, with the finer aggregation occurring at the level of service centre

o a minimum aggregation size (N=5) is applied in the case of privacy-critical variables (e.g. service centre, geographical site, etc.) and/or when multidimensional patterns are required (subgroups analysis, risk adjustment, etc)

o any DATE fields must be approximated to time interval (e.g. Months) o a pseudonym will be used for any service centre o each local administrator will be granted user/password access o the local administrator will personally prompt data exchange through a

client program that will send encrypted bundles to the BIRO Server o aggregated data represent an average over time o aggregated data accessible only to a BIRO database administrator o the BIRO server is located at the Coordinating Centre site (strictly

implementing all security measures imposed to protect data). Annex B describes the flow of information through the BIRO Information

System, as agreed by all partners, representing the final data flow table of the BIRO project and the final BIRO System Diagram.

Final report of Privacy Impact Assessment Step 2 (D5.2) has been delivered on September 2007.

The next step of Privacy Impact Assessment will address potential privacy risks in the best architecture identified, and identify any mitigation strategies.

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Figure 6 – Summary of the BIRO Data Flow resulting from the Privacy Impact Assessment

UNIPG UNIDUND JOANNEUM UNIBERG PAULESCU UNIMALT

SEDIS

BIRO

COORDINATION CENTRE (UNIPG)

§ Data aggregated by group of patients (Min. N=5 patients per cell)

§ Data aggregated at level of service centre

§ Aggregation of multidimentional patterns allowed (Min. N=5 conditions applied

SECURITY § Password access for local

administrator prompting client program to send encrypted bundles to BIRO

TRANSMISSION

§ DATE fields approximated to time interval

§ Pseudonym used for service centre

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WP6. Database Engine (M7 – M32)

Goal of this WP, led by UNIPG, is to develop a specialised database software allowing to use the XML schema produced in WP3/WP4 at each participating region.

2006 activities and results The first step in the WP activity was to highlight differences between the

Database and Central Engines. At the 1st BIRO Investigators Meeting (St. Julian, Malta, 30th May-2nd June

2006) the consortium agreed that each individual partner needed to build own local ‘register system’, including a specific ‘adaptor’ tool that would export data towards a common XML file format.

The Consortium also agreed that software used to build the database engine will be PostgreSQL (eventually translated into other SQL dialects). Programming language of choice was JAVA rel.5.0 (1.4.2 for compatibility). XML data mapping software was chosen to speed up data export.

A first draft of the SQL architecture of the database was also produced. Software tools to import data into the DBMS were designed and implemented.

2007 activities and results At the 3rd BIRO technical meeting held in Dundee (26-27 March 2007),

colleagues from UNIDUND presented a draft of the BIRO XML schema as a fundamental component to be used for the construction of the Database Engine. Partners agreed that each centre had to use software built by UNIPG to load data from the XML export towards a local database whose tables must be processed either by SQL and/or ad hoc statistical software.

The Consortium discussed ho to build a BIRO Adaptor, i.e. a simple tool that could be used to convert local data formats towards a common BIRO XML export.

At the 2nd BIRO investigators’ meeting (Cyprus, 23rd -26th May 2007), UNIPG showed the structure and functionality of “RRDM2BIRO Converter”, an example of implementation of BIRO Adaptor on the Umbria Diabetes Register. It was agreed that UNIPG could release this tool as an official BIROAdaptor, thus as an integral part of the Database Engine.

During the meeting, the issue of data transfer from an XML document to the BIRO database using the BIRO XML was also discussed. Here partners were introduced for the first time to the design of the database engine.

The storing process is composed of four consecutive steps: creation of a java object model from the XML schema; generation of DDL from the java object model; creation of java objects from XML document; mapping of java objects into database records (see Figure 7). Some changes to the XML schema were also suggested to avoid name collisions between the Java Objects.

Several months were dedicated to the improvement of the BIRO Adaptor. UNIPG developed the connection between the BIRO Adaptor and the major DBMS, testing its use on datasets from the Umbria Register. Data storing has been completely implemented and refined in order to manage great amount of data with sustainable performances. Tests of data storing were performed in Perugia with encouraging results. Both the BIRO Adaptor and the BIRO Data Storing Tool have been used to can explain all intermediate steps allowing producing a statistical report out of a regional database.

Deliverable D6.1 “Database Engine” has been delivered in January 2008.

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Figure 7. Database Engine

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WP7. Reports Template (M7 – M32)

Aim of WP7 is to define a structure for diabetes health reports that will be used across international regions. University of Bergen (UNIBERG) with the support of NOKLUS (Norvegian Centre for Quality Improvement in Primary Health Care) is the leading partner for the development of this WP.

The Reports Template was designed to build upon deliverables Clinical Review, Common Dataset and Data Dictionary as a guide for the work of the Statistical Engine.

2006 activities and results An analysis of existing diabetes reports has been conducted at the Graz

Meeting. WP leaders collected examples from partners with previous experience in the production of diabetes reports.

During the meeting, partners identified the possible means of visualization: maps boxplots, bars, lines, performance meters and starplots. Stratification variables where also chosen, including age, type of diabetes, care type, patient case-mix categories, co-morbidity factors, geographical region (or areas within regions). Partners agreed on the need of producing an executive document with strong policy interpretation. The preliminary volume index was drafted as a result of this meeting.

2007 activities and results At the Dundee BIRO technical meeting (26-27 March 2007) the Consortium

agreed on the need of changing the representation format of the reports template according to the target audience (albeit parameters/indicators may be repeated across different users).

UNIBERG met with the Technical Coordinator in Italy in early May to produce a draft structure of the report.

At the 2nd BIRO investigators’ meeting (Cyprus, 23rd -26th May 2007) UNIBERG reported the results of this short session. The document was further developed through the presentation of the report structure. Considerations were made on the choice of outcome indicators, on different ways of cross-linking data through the analysis of coherence/consistencies, on difficulties in creating epidemiological maps at the sub-regional level, and on different ways that could be used to represent data quality. Partners were asked to provide preferences on the final list of target measures.

On July 2007 the document D7.1 “Reports Template” was delivered to the European Commission. The report is designed to satisfy the need for different types of audience, reflecting the full scope of the project. Reports Template will be consistently used to present results for all diabetes reports based upon specific profiles. In practical terms, when making the choice “Diabetes reports” or “Diabetes overview Europe” on the BIRO web-page, the user will be asked whether he/she will proceed according to one of the following categories: governance; health care and research; people with diabetes and citizens.

Each report includes a list of target measures, output and indicators (see Figure 8). The deliverable assigns a specific priority and feasibility score to each parameter. It also provides a detailed list of statistical outputs (e.g. tables, lines, histograms, maps, starplots, etc.) for each indicator and for each BIRO-user. All indicators have been properly stratified using patient characteristics (e.g. age, gender, type of Diabetes, region, Diabetes duration, etc.).

The Reports Template will be continuously updated based upon the results of other WPs.

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Figure 8. Extract from Reports Template

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WP8. Statistical Engine (M7 – M30)

This WP will deliver a set of powerful statistical tools to transform data gathered in different regions into usable information and customised reports.

WP8 is led by UNIPG with the support of subcontractor Serectrix. 2006 activities and results The main statistical packages used for the scope were discussed at the Malta

meeting at M7. A mixed development of SAS and R was identified as a possible platform, with R to be preferred over SAS whenever possible, particularly to support the use of statistical routines for local registers.

An example of the application of statistical tools to diabetes data has been presented at the subsequent Graz meeting, in the context of the first data analysis performed on linked data in the Umbria Region. Basic descriptive analysis were performed at M12 using the beta release of the statistical engine. A first application written in SAS deployed an automatic standardized report for each diabetes centre.

2007 activities and results At the Dundee BIRO technical meeting (26-27 March 2007, M16) UNIPG

showed the ad hoc SAS software developed. Frequency tables obtained from a “Merge Table” were shown. Missing data were used to evaluate the quality of data collected. Graphical outputs planned in Graz e.g. histograms and starplots were also included in the report.

A second set of routines including risk adjustment techniques were also applied, showing how regional registers can be used to compare observed to expected outcomes, based on multivariate models using the overall population to standardize results. UNIPG showed an example of how using aggregated data leads to identical results obtained from individual data in the case of logistic regression (which validates the BIRO application). Data from multiple Umbria centres were split by centre to resemble the case of multiple European sites. The exercise assumes that we want to risk adjust by gender (males) and age categories.

Results were remarked at the 2nd BIRO investigators’ meeting (Cyprus, 23rd -26th May 2007) with a presentation of an extended example in the presence of independent evaluators. The plan for the translation of all routines in R was introduced to the Consortium partners. Construction of a BIRO Prototype was agreed for all steps, from data collection to the production of the statistical output, demonstrating how the entire BIRO system would work. Partners agreed that it was critical to understand the complete method, and that a realistic deadline for the test runs was end 2007.

The BIRO Prototype was presented at the 2nd Annual BIRO meeting in Rome. (M25). The database used for the application was a merge of clinical data from the Umbria Diabetes Register and administrative data from the Regional Department of Health. Beta release of the Statistical Engine (see Figure 9) connects to the BIRO Database, retrieves data and performs statistical analysis through all functionalities of “R”. Results are automatically printed to a report using specifications given by the Reports Template. R calls Latex routines to directly print tables, barplots, starplots and other graphical outputs into a pdf file.

The prototype will be completed in May 2009.

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Figure 9. Statistical Engine

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WP9. Communication Software (M7 – M24)

Aim of WP9, led by JOANNEUM, is to build an interface that transmits data from the local BIRO system to the central server in a secure way. The transmitted message will contain statistical objects produced by R/SAS, according to a pre-specified standardized format.

2006 activities and results Use of Web services was chosen by the leader based upon the following

desired characteristics: XML-based communication, usable over Internet protocols, availability of Open Source implementations, availability of security features (encryption, digital signatures), based on an open and platform-independent standard.

In a pilot implementation, two J2EE Application Servers were set up for sender and receiver, respectively. A sample service was implemented based on the Apache Axis framework, which provides submission of arbitrary files. The Apache Rampart framework was used and configured to establish encryption and digital signatures.

2007 activities and results At the Dundee BIRO technical meeting (26-27 March 2007, M16) the WP

leader presented the final features of the system and an overview of the protocol for transmission, encryption, and authentication. Partners discussed how/when data would have been transmitted from local centre to the central server (can either prompted by a remote user, or done automatically), requesting input from Privacy Impact Assessment. Results of WP5 obtained in Cyprus (M18) prompted the final implementation of the software (see Figure 10).

The prototype was successfully tested and found very suitable for application in the BIRO architecture identified. Performance measures showed a remarkable communication overhead, but this was not rated critically, because data transmission in BIRO occurs with low frequencies.

Security was established in two layers. Firstly, on the communication layer, the entire communication is encrypted and authentication can be enforced via the HTTPS protocol. Secondly, the payload of the SOAP message is encrypted and signed, so that security features persists also after the transmission over the network.

Deliverable D9.1 “Communication software” has been delivered in January 2008 (M26).

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Figure 10. Communication Software

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WP10. Central Engine (M13 – M30)

Aim of WP10, led by UNIPG, is to set the technology required to compile results from the individual regions into a coherent system, able to perform analyses across distributed databases and to deliver outputs to the web portal.

2007 activities and results UNIPG introduced at the Dundee BIRO technical meeting (26-27 March 2007,

M16) the structure and initial source code to be used for the construction of the Central Engine.

An example was produced, based on the use of aggregated tables (statistical objects) collected from each centre, using patterns observed from different combinations of gender and age. The same method can be used to deliver basic and advanced routines producing results that are identical to those obtained from complete individual data. The example showed that, as far as logistic regression is concerned, using a set of aggregated tables from multiple sites leads to same parameter estimates than those obtained on top of the complete dataset, using all original individual data. Outputs of the multivariate model and graphical outputs e.g. starplots (see Figure 11) were included in the example.

Results were further elaborated and introduced to the independent evaluators at the 2nd BIRO investigators’ meeting (Cyprus, 23rd -26th May 2007, M18), using linked data from the Umbria Diabetes Register and the Regional Department of Health.

Source code is currently being developed in parallel with the construction of the database and statistical engines. All routines need to take into account the format of aggregate tables, managed by the Database engine, and must link to the R statistical routines written for the Statistical Engine that delivers the “partial” statistical objects.

Figure 11. Results from the early development of source code for the Central Engine

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WP11. Web Portal (M25 – M36)

Aim of WP11, led by UNIBERG, is to develop a web interface to display and present all results obtained from WP1-WP10.

2007 activities and results Activities started early in May 2007 (M18) with an analysis of the construction

of the web report, reflecting the agreed contents of the Reports Template (see Figure 12). Discussions at the Cyprus Meeting focused on the best technology to be used for this representation. It was agreed that further specifications of the BIRO system were required to develop a targeted application.

WP is planned to develop according to the initial plan (start at M25), building upon results obtained earlier.

Figure 12. Outline of the draft Web Portal

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WP12. Technology Transfer (M1 – M36)

Aim of this WP, coordinated by PAULESCU, is to ensure the scalability and extensibility of the product for new regions where programs for chronic disease management and diabetes prevention are currently in progress. Regions may experience problems in performing all technical steps required to export/import data. Technology Transfer links to all basic activities for database processing that are currently underway, including the construction of local adaptors and data management.

2006 activities and results The first activity undertaken included the analysis of the situation in 3

new/acceding EU Member States: Romania, Malta and Cyprus. A dedicated “Technology Transfer Workshop” held at the Malta Investigator

Meeting allowed to deliver the initial index for the final report. A draft Preliminary Technology Transfer Report was then delivered by PAULESCU using the same template.

The workshop has demonstrated the current involvement of the Maltese Department of Health in the establishment of diabetes information systems for integrated clinical management.

2007 activities and results The Dundee BIRO technical meeting (26-27 March 2007) included an update

of the situation in Malta, Cyprus and Romania. Briefly, it seems that data collection/processing is fairly possible in Malta provided that a technical person is nominated to facilitate the extraction of records from the system.

The Cyprus partner reported that data collection just started on the island through the activation of first diabetes clinic. An academic institution, Warwick University, is involved in providing professional education to local clinicians on various aspects of chronic disease management. A short list of items has been selected and a simple form has been prepared. Although a computerized database is not yet available, development of an Access application is ongoing and the Ministry ensure they will deliver a first release with automated data collection from clinical sites.

PAULESCU presented an update of the Technology Transfer Report. At the 2nd BIRO investigators’ meeting (Cyprus, 23rd -26th May 2007)

PAULESCU presented an overview of the BIRO solution and the recent developments discussed in a Romanian Conference, including concepts related to the transfer and usage of electronic health care records. The WP leader pointed out that data collection from different geographical area presents different critical points such as data validation, patient privacy and data security.

The Cyprus MOH presented an overview of the organization of the Larnaca Diabetes Centre, clearly mentioning that the BIRO collaboration allowed opening the first Diabetes Centre in Cyprus. BIRO has brought to the attention of clinical leaders across the highland the importance of data collection and detailed patient information available at the clinical site. A new IT platform has been developed for the scope and is starting to collect data that underpin the construction of the Cyprus Diabetes Register.

Dr. Andreas Polinikis underlined the intention of the Ministry of Health to back the project up through the involvement of other clinical centres of the Republic.

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Figure 13. Index of the Technology Transfer Analysis

Table of Contents Acknowledgments Executive Summary

Background SECTION 1. LOCAL SETTING (WHERE WE ARE NOW)

Situation in Cyprus (max 20 pages)

• Diabetes Health Care Management (3 pages) • Information: where is it gathered, how is gathered (4 pages) • How is data defined (data dictionary, items, minimum dataset, standards) (6 pages) • Information systems (4 pages) • Users (3 pages)

Situation in Malta (max 20 pages)

- same as above Situation in Romania (max 20 pages)

- same as above

SECTION 2. BIRO ADOPTION (WHERE WE DO WANT TO GO) Adaptation, implementation, setup and use of BIRO in Cyprus, Malta and Romania

• Relevance and use of BIRO indicators (WP2) • Relevance and use of the BIRO dataset (WP3) • BIRO technology (WP6-WP9)

o Hardware/Connectivity o Client -server application o Statistical software o Data migration tools

• Different Privacy legislation (WP5) • Connection to EU information systems (Web Portal, WP 11)

Scalability and extensibility of the BIRO product to Malta, Cyprus and Romania

• Additional specific tools for technology transfer • Usage and availability of open source software • Compliance of policy programs (national diabetes plan, national health information

system plan, etc) with the BIRO specification • Risks of the local application • Difficulties in the transferability of particular specifications

SECTION 3. DISSEMINATION AND TRAINING ACTIVITIES (HOW TO DO IT)

Report from site visits and presentation of the BIRO material (feedback from local audience, including clinicians, diabetic association, policy maker, results of training for governmental institutions)

• Brief of BIRO Information Meeting in Cyprus, Malta and Romania • Brief of BIRO Training Session in Cyprus, Malta and Romania • Report from the Final Technology Transfer workshop (June 2008 in Romania)

CONCLUSIONS

• Final comments • Recommendations for future inclusion of new partners in the BIRO collaboration

REFERENCES

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WP13. Project Management (M1 – M36)

Aim of this WP, led by UNIPG, is to monitor content and progress of each WP through the supervision of all activities. Management will ensure that the process flow proceeds in accordance with the project's objectives.

WP13 provided the following activities in 2006-2007: o constant monitoring of project development o financial management of the project; o financial support and reporting (draft and consolidated cost statements) o meeting organization (particularly the organization of the 2nd BIRO

Annual Meeting in Rome - 3rd December 2007) o preparation of meeting agenda and minutes o coordination of the dissemination activities o maintenance of the project website o contractual arrangements with Webred (a company that manage

several health care information system in the Umbria Region) for BIRO web hosting and remote data storage

o preparation of the official documents for the commission The WP produced also a “Revised project meeting plan”, based upon the

initial structure from major WPs (see Figure 3). The plan is now foreseeing the following meetings:

o Dundee, March 2007 o 2nd Investigators Meeting, Cyprus, June 2007 o Bergen, September 2007 o 3rd Investigator Meeting, Bucharest, early June 2008 (Final

Technology Workshop) o Concluding Meeting, Perugia (satellite EASD), September 2008

Figure 13. Original meeting plan from the revised Workplan

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WP14. Dissemination (M1 – M36)

Aim of this WP, led by UNIPG, is to ensure that the contents of the program and the associated deliverables become widely available with a correct development and dissemination of the program across participants.

2006 activities and results o BIRO website completed and constantly updated (www.biro-project.eu).

The website contains a public area with general information and results, as well as a restricted area for project members and use by the Commission.

o BIRO Forum. The forum allows members of the project to reciprocally communicate. A public area allows external users to express comments and ides on the project.

o BIRO Newsletter. The newsletter contains articles, written by project members, about B.I.R.O. project, including state of the art of the activities, meetings minutes, people story, conferences and relevant information on related topics (e.g. updated list of important meetings and activities on diabetes care or public health)

o BIRO brochures. 1000 brochures have been printed in two different formats and distributed at various congresses.

o Abstract entitled “Best Information through Regional Outcomes: a European network to enhance monitoring of quality and outcomes in diabetes care” accepted as a poster presentation to the International Diabetes Federation Congress (Cape Town, December 2006). Policy document “The role of BIRO in implementing the Diabetes EU” released.

o Policy recommendations” indicating how BIRO can translate local action into European policy (Vienna Declaration on Diabetes-Diabetes - EU Policy Recommendations) using health information as a strategic component for the coordinated and continuous prevention, care and management of diabetes

o Analysis of the potential BIRO users. The Consortium identified four specific domains interested in BIRO outputs: a) governance; b) research; c) health care; and d) citizens.

2007 activities and results o BIRO website (www.biro-project.eu) structure changed to simplify the

approach of new users with BIRO objectives and activities o activities, documents and results sections constantly updated o May 2007. Conference Abstracts accepted at the Romanian National

Diabetes Conference, 16-19 May 2007, Bucharest, Romania o December 2007. Contribution to the European Report on Major and

Chronic Diseases, DG-SANCO 2008 o Conference Abstract accepted, Diabetes UK Annual Professional

Conference, 5-7th March 2008, Glasgow, Scotland, UK o new topics have been added to BIRO Forum. It has also been used to

diffuse among partners an early version of the BIRO Adaptor software tool in order to test it in different centres.

o BIRO Newsletter 1, BIRO Newsletter 2 and BIRO Newsletter 3 have been realized and published in the documents section of the BIRO website (see Figure 14).

o A new BIRO Brochure has been designed. More that 500 copies have been printed. The brochures have been distributed at the European Health Forum Gastein in October 2007

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Figure 14. The BIRO Newsletter

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WP15. Evaluation (M7 – M36)

Aim of this WP, led by UNIMALT, is to provide the Consortium and the European Commission with an external evaluation of what the project has achieved. Program is split in three annual reviews, for which the Consortium will involve external independent experts that will provide feedback on all project implications in the specific fields of Clinical Practice, Information Technology and Epidemiology/ Statistics.

2006 activities and results At the Graz Biro Meeting the WP leader presented two external high calibre

evaluators identified for the Clinical Practice and Epidemiology section: Fred Storms (CBO, NL) and Amanda Adler (Un.Oxford, Un.Cambridge).

At the end of the year, the WP leader submitted evaluators questionnaires and all BIRO material currently available (particularly Clinical Review and Data Dictionary draft), granting them full access to the restricted area of BIRO website. After browsing all material, evaluators delivered their report in December 2006, D15.1 “First Year Evaluation Report”

2007 activities and results At the Dundee BIRO technical meeting (26-27 March 2007) the Consortium

noticed that comments made by evaluators were relevant and very useful for the updating of both the Clinical Review and Data Dictionary. Experts were invited to the 2nd BIRO investigators’ meeting (Cyprus, 23rd -26th May 2007). A dedicated session was facilitated by J.Azzopardi (UNIMALT) and all the points raised by evaluators were jointly discussed.

Although the quality of the Consortium was acknowledged to be overall of high level, critical aspects of “Clinical Review” and “Common Dataset” were highlighted and corrected.

At the end of the year, all technical deliverables were submitted again to same evaluators, including a new expert included for Information Technology.

Interim second evaluation report has been delivered in January 2008.

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1.2 Deliverables Table 1. List of deliverables

# Deliverable Code and Name WP Leader

Planned Delivery

Date

Actual Delivery

Date

1 D2.1 “Clinical Review” JOANNEUM 01/06/2006 14/07/2006 2 D3.1 “Common Dataset” UNIDUND 01/12/2006 18/01/2007 3 D5.1 “Preliminary Privacy Impact Assessment” UNIPG 01/12/2006 20/12/2006 4 D13.1 “Technical Implementation Year 1” UNIPG 01/12/2006 03/01/2007 5 D15.1 “Evaluation Report Year 1” UNIMALT 01/12/2006 12/12/2006

6 D7.1 “Reports Template” UNIBERG 01/06/2007 05/07/2007 7 D4.1 “Data Dictionary” UNIDUND 01/06/2007 19/10/2007 8 D4.2 “XML Metadata Dictionary” UNIDUND 01/06/2007 19/10/2007 9 D5.2 “Data Flow Analysis Report” UNIPG 01/08/2007 16/09/2007 10 D6.1 “Database Engine” UNIPG 01/12/2007 30/01/2008 11 D9.1 “Communication Software” JOANNEUM 01/12/2007 30/01/2008 12 D13.1 “Technical Implementation Year 2” UNIPG 01/12/2007 30/01/2008 13 D15.2 “Evaluation Report Year 2” UNIMALT 01/12/2007 30/01/2008

14 D5.3 “Privacy Analysis Report” UNIPG 01/04/2008 15 D8.1 “Statistical Engine” UNIPG 01/06/2008 16 D8.1 “Central Engine” UNIPG 01/06/2008 17 D14.1 “Web Report Base” UNIPG 01/06/2008 18 D12.1 “Technology Transfer Workshop” PAULESCU 01/07/2008 19 D2.2 “Clinical Review Update” JOANNEUM 01/08/2008 20 D4.3 “XML Metadata Dictionary Update” UNIDUND 01/08/2008 21 D5.4 “Final Privacy Impact Analysis Report” UNIPG 01/08/2008 22 D6.2 “Database Engine Update” UNIPG 01/08/2008 23 D7.2 “XML Metadata Report” UNIBERG 01/08/2008 24 D11.1 “Web Portal Template” UNIBERG 01/08/2008 25 D12.1 “Technology Transfer Analysis” PAULESCU 01/10/2008 26 D14.2 “Plenary Session” UNIPG 01/11/2008 27 D14.3 “Web Report Revised” UNIPG 01/12/2008 28 D14.4 “Monograph: Diabetes ‘Health Systems’” UNIPG 01/12/2008 29 D15.3 “Evaluation Report Year 3” UNIMALT 01/12/2008 30 D13.3 “Final Progress Report” UNIPG 01/12/2008

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1.3 Deviations from Plan Causes and Description Corrective actions

Delayed submission of deliverables: D4.1: Data Dictionary D4.2: XML Metadata Dictionary

Preparation of deliverables took longer than expected in the original plan. Extended discussion at the Cyprus meeting involved an in depth revision of all the definitions. New reports were produced and finally revised by all Consortium partners in September 2007.

1.4 – Other Causes and Description Corrective actions

On April 2006, Douglas Boyle left his position at the University of Dundee and his role in the project as IT expert.

Position of medical informatician was taken over by Scott Cunningham, now the main contact person for the project at UNIDUND.

On May 2007, Pietro Palladino left his role as full time database administrator

The role of database administrator is now shared by Valentina Baglioni and Pietro Palladino

On September 2007, Dr. Marco Orsini Federici left his position at the University of Perugia and his roles of project manager, researcher, clinical expert.

The role of project manager was taken over by Valentina Baglioni. The role of researcher has been taken over by Luca Rossi. An epidemiologist is currently being recruited for the role of clinical expert.

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2 – Contractual arrangements

Change of budget items due to additional funds allocated to the project

The Coordinator has received additional funds to support its action: on 31st May 2005 from the

“Fondazione Cassa di Risparmio”, a no profit institution supporting local organizations in the conduction of funded projects. The Fondazione assigned B.I.R.O a grant of €15.000 for the purchase of equipment. On 06th September 2006, an official communication was sent to the competent DG-SANCO Office, requesting a shift of €11.525 from those originally allocated to purchase equipment, to miscellaneous costs (in particular, to allow for changes in the daily rates of staff employed in the BIRO project).

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3 - Project Meetings

3.1 – Held and foreseen in Project Programme MEETING #1 Title Kick off Meeting Date 5th December 2005 Place Perugia, Italy Participants from project

• Massimo Massi Benedetti, Fabrizio Carinci, Marco Orsini-Federici, Tania Di Iorio, Alessia Muscari, Anna Rita Ragni (University of Perugia)

• Douglas Boyle, Scott Cunningham (University of Dundee) • Peter Beck (Joanneum Research) • Simion Pruna (Paulescu) • Svein Skeie (University of Bergen) • Joseph Azzopardi (University. of Malta) • George Olympios (Cyprus Ministry of Health)

Main conclusions

• The meeting focused on the discussion of the workplan and allowed to agree all operational steps required to realize its major objectives.

• The meeting allowed defining the foundations of the BIRO infrastructure through a flexible Data Set and a Data Dictionary integrating all major diabetes indicators. Partners agreed that registries with varying levels of completeness will be connected through a common, simpler dataset.

• The meeting was focused on the discussion of general characteristics of the project in order to understand the real objectives and define operative steps towards the realization of it. It was clearly remarked that the project does not aim at developing a system for disease management nor to create new indicators for diabetes neither to build up new local registers; the real added value can be represented by the multilevel approach and the advanced statistical analysis of data already available in place.

• Partners agreed to concentrate on the application of advanced statistical analysis on data systems that are already in place. The system should not be comprehensive from the beginning; it should have flexible Data Set and Data Dictionary to integrate possible new indicators, thus it will more feasible its transfer to developing countries. The preferable option is a system that can merge a simpler one with a minimum data set and a more comprehensive one with further data, to be used in different areas.

• The meeting was also the occasion to introduce the Coordinating Centre and to discuss all administrative issues.

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MEETING #2 Title 1st BIRO Technology meeting Date 6th -7th March 2006 Place Dundee, Scotland Participants from project

• Fabrizio Carinci, Marco Orsini Federici, Pietro Palladino (University of Perugia) • Douglas Boyle, Scot Cunningham Graham Leese, (University of Dundee) • Peter Beck (Joanneum Research) • Simion Pruna (Paulescu) • Svein Skeie (University of Bergen) • Joseph Azzopardi (University of Malta) • Fred Storms (external evaluator)

Main conclusions

• The Consortium agreed that individual data could only be processed at the local level to produce aggregated tables that are shared to produce target indicators. At the same time, it has been decided that the desired level of aggregation must be finely tuned by the Consortium on the basis of both technological and privacy protection issues. A common XML must be defined to harmonize information extracted from different sources.

• Target diabetes indicators should be driven by a proper consideration of the different categories of BIRO users

• Fred Storms from the EUDIP/EUCIP Consortia provided an overview of the projects, indicating their complementarity to the BIRO approach.

• The meeting addressed fundamental organizational/technical issues. Partners approved the revised BIRO workplan which integrates the original project with issues raised during Perugia Meeting. Governance bodies were defined with nomination of partners for the different boards.

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MEETING #3 Title 1st Annual B.I.R.O. Investigators Meeting Date 30th May – 2nd June 2006 Place St. Julian, Malta Participants from project

• Massimo Massi Benedetti, Fabrizio Carinci, Marco Orsini-Federici, Pietro Palladino (University of Perugia)

• Scott Cunningham, (University of Dundee) • Peter Beck, Wolfgang Habacher (Joanneum Research) • Svein Skeie, Peter Taverner (University of Bergen) • Simion Pruna, Constantin Ionescu-Tirgoviste (Paulescu) • Joseph Azzopardi, Stephen Fava, Josanne Vassallo, Natasha Muscat Azzopardi, Gloria

Cassar, Oscar Calafato (University of Malta) • George Olympios, Vivie Traynor, Yianna Demetriou, (Cyprus Ministry of Health)

Main conclusions

• Partners revised the draft of the Deliverable "Clinical review” choosing the best indicators to be included in the BIRO short list as target outputs of data analysis.

• The Project Coordination Board defined the categories of BIRO users that are to be taken into account to drive the development of all BIRO templates and the associated web portal.

• The Malta meeting included a special session on Technology Transfer. The dedicated workshop produced an overview of the current situation in Malta, Cyprus and Romania. The workshop allowed specifying the Technology Transfer Report Index that describes all the activities foreseen for the specific WP.

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MEETING #4 Title Graz Biro Meeting Date 29th -30th September 2006 Place Graz, Austria Participants from project

• Fabrizio Carinci, Marco Orsini-Federici, Pietro Palladino, Annarita Ragni (University of Perugia)

• Scott Cunningham, Graham Leese (University of Dundee) • Thomas Pieber, Peter Beck, (Joanneum Research) • Peter Taverner (University of Bergen) • Joseph Azzopardi (University of Malta) • George Olympios, Vivie Traynor, Andonis (Cyprus Ministry of Health)

Main conclusions

• A new BIRO brochure and the BIRO website were presented to all partners. • The meeting allowed refining and completing concepts associated to the data dictionary

after the delivery of the clinical review. • The Graz meeting represented a turning point for the implementation of BIRO project. Firm

steps for the construction of the system were undertaken.The meeting allowed to conduct a "requirement analysis" for the B.I.R.O data model and to define major software specifications as well as the prospective alternatives for the B.I.R.O architecture.

• Partners also discussed in detail the plan of the Privacy Impact Assessment (WP5). The principal aspect identified was the importance of raising the awareness of the problem of personal data protection that is still not highly regarded among researchers and data users. It was remarked that it is essential that the architecture and the Consortium are well prepared to move from one privacy policy to a more restrictive one, the latter being a likely scenario for the future European framework.

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MEETING #5 Title Dundee BIRO Technical Meeting Date 26th -27th March 2007 Place Dundee, Scotland Participants from project

• Massimo Massi Benedetti, Fabrizio Carinci, Marco Orsini-Federici (University of Perugia) • Tania Di Iorio (Serectrix) • Scott Cunningham, Graham Leese, Andrew Morris (University of Dundee) • Peter Beck, Phillip Perner (Joanneum Research) • Peter Taverner (University of Bergen) • Simion Pruna (Paulescu Institute) • Joseph Azzopardi (University of Malta) • George Olympios, Vivie Traynor, Andriana Evripidou (Cyprus Ministry of Health)

Main conclusions

• The meeting focused on three major topics: technical aspects, privacy impact and new EU applications

• The data dictionary and a final draft of the BIRO XML Schema were presented for discussion. A database engine pilot application built on top of the Umbria database was introduced as the basis of a test application of the statistical engine. A plan for the structure of a pilot data analysis and aggregate tables required was presented.

• The facilitator of Privacy Impact Assessment (WP5) summarized the result of activities carried out, including a review of the literature, the identification of the main alternatives for the BIRO privacy architecture, the major implications of each option, and the future steps that will be required to evaluate the information flow.

• A plan for a new tool for the secure transmission of data bundles from each partner to the central server and web portal has been presented by Joanneum Institute in the framework of activities of WP Communication Software.

• Updates of the situation in Romania, Malta and Cyprus have been provided. Representatives from the Cyprus Ministry of Health reported that B.I.R.O. is having a major impact on the activation of the diabetes register across the island. After just one year from the start of the project, Cyprus represents the first example of the use of the B.I.R.O. dataset as a European standard for data collection and systematic reporting of diabetes data.

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MEETING #6 Title 2nd BIRO Investigators’ Meeting Date 23th -26th May 2007 Place Larnaca, Cyprus Participants from project

• Massimo Massi Benedetti, Fabrizio Carinci, Marco Orsini-Federici, Valentina Baglioni, Pietro Palladino, Anna Rita Ragni (University of Perugia)

• Tania Di Iorio (Serectrix) • Scott Cunningham (University of Dundee) • Peter Beck (Joanneum Research) • Sven Skjie, Karianne Lovaas, Peter Taverner (University of Bergen) • Simion Pruna (Paulescu Institute) • Joseph Azzopardi (University of Malta) • George Olympios, Vivie Traynor, Andriana Evripidou, Andreas Polinikis, Pantelitsa

Erotokritou (Cyprus Ministry of Health) • Amanda Adler, Fred Storms (Independent Evaluators)

Main conclusions

• The Cyprus Diabetes Association provided substantial support throughout the meeting, offering continued assistance to all participants, organizing a wonderful hospitality, and showing a genuine interest for the BIRO project. The plenary session was formally opened by the Chief Medical Officer, Ministry of Health of the Republic of Cyprus, Dr. Andreas Polynikis.

• Leaders of the Larnaca Diabetes Centre announced that the BIRO collaboration, through an increased level of attention for diabetes outcomes, has triggered both the development of the Cyprus Diabetes Register and the organization of the first diabetes clinic on the island.

• High-calibre BIRO independent evaluators Amanda Adler (Un.Cambridge and Un.Oxford, UK) and Fred Storms (CBO NL) offered the Consortium their valuable input, by presenting their views and detailed suggestions for the improvement of 2006 project deliverables in the areas WP2-WP3. Corrections agreed will be immediately included in forthcoming deliverables.

• Data dictionary and exchange XML format (WP4) have been finalised for delivery (confirmed end August 2007). Structure and functionality of tools for data export have been discussed in relation to the use of the BIRO XML format. Issues of data transfer from XML document to the BIRO database, and the development of related specialised software, have been agreed, based on Castor software.

• The Privacy Impact Assessment (WP5) Consensus Panel has been successfully conducted through the use of a questionnaire submitted to all participants. The activity allowed choosing the best architecture for the BIRO framework. All results included in the deliverable.

• The BIRO Diabetes Reports Template has been discussed in detail. A final document has been agreed and will be ready for publication August 2007. An example of the use of the statistical engine showed the basic functionalities of a complete working example, scheduled to be available end 2007.

• Critical issues of data transfer from different geographical areas have been discussed in relation to the technological transfer oof the prototype to other regions. A planned expansion of the Consortium has been recently submitted to the attention of DG-SANCO.

• Partners agreed that the project deserved to be widely published. Furthermore, original FP7 research proposals must be formulated to fully exploit the potential of the BIRO database for the benefit of European policy makers.

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3.2 – not held and foreseen in Project Programme

Title Date Place Participants

from project Reasons

Technology Transfer meeting

September 2006

Bucharest UNIPG, UNIDUND, PAULESCU

At the Malta meeting the PCB decided to revise the project travel plan, reducing the overall number of meetings to a manageable size and ensuring that all partners could participate.

Bergen Meeting

September 2007

Bergen, Norway

UNIPG, UNIDUND, PAULESCU, UNIMALT, CYPRUS, UNIBERG, JOANNEUM

After the 2nd Annual Meeting in Cyprus, the Consortium agreed to postpone the meeting due to the cost of the trip and the necessity to meet more partners. Meeting location has been moved to Rome.

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3.3 – Held and NOT foreseen in Project Programme MEETING #7 Title 4th BIRO Technical Meeting Date 3rd December 2007 Place Rome, Italy Participants from project

• Massimo Massi Benedetti, Fabrizio Carinci, Marco Orsini-Federici, Valentina Baglioni, Pietro Palladino, Anna Rita Ragni, Luca Rossi, Fabrizio Stracci (University of Perugia)

• Scott Cunningham, Massimo Brillante (University of Dundee) • Peter Beck (Joanneum Research) • Sven Skjie, Karianne Lovaas (University of Bergen) • Simion Pruna (Paulescu Institute) • Joseph Azzopardi (University of Malta) • George Olympios, Vivie Traynor, Andriana Evripidou (Cyprus Ministry of Health) • Fred Storms (Independent Evaluator, CBO Netherlands)

Main conclusions

• This one-day meeting focused on technical aspects related to the construction of the information infrastructure, its easy of use, risks and opportunities that the novel platform could be quickly adopted by more partners

• The contribution of the BIRO Consortium to the preparation of SANCO MCD Report was discussed directly with the coordinator of the EUCID project, Dr.Fred Storms (CBO).

• Leaders of WPs Coordination, Database Engine and Statistical Engine introduced a working example of the use of the BIRO prototype, based on data from a single register (Umbria Diabetes Register). Methods and software used for the development of the BIRO Data Adaptor, Database and Statistical software were presented in detail

• Required updates for data dictionary and reports template highlighted • New directions to share all software on a common repository and to build up a coherent

information system were agreed with the Chair of the Software Coordination Board, P.Beck (Joanneum)

• Communication software delivered by Joanneum Research was presented by P.Beck. • Guidelines for the conduction of 2nd Year Evaluation were agreed with WP leader J.Azzopardi • The role of the BIRO Consortium in the framework of a broader collaboration (EUBIROD

project) was also discussed. Participant from Kuwait reported his comments on the possible use of BIRO outside Europe.

• Plans for coordination, management and dissemination in 2008 were agreed with all partners

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4 – Dissemination / Promotional Information

4.1 Conferences and/or Workshops attended/organised/foreseen by the project Date Title Number of persons attended + other information 4-6th October 2006

European Health Forum 2006, Gastein, Austria

Fabrizio Carinci (UNIPG) attended the meeting (expenses covered by external funds). Over 100 copies of the BIRO brochure 2006 have been distributed

3–5th November 2006

IDF Europe annual meeting, Warsaw, Poland

Massimo Massi Benedetti (UNIPG) attended the meeting (expenses covered by external funds). Over 100 copies of the BIRO Brochure 2006 distributed to relevant stakeholders. Contacts have been established with IDF Europe representatives and with responsible of diabetes registers in different European countries in order to expand the BIRO experience.

3-7th December 2006.

International Diabetes Federation Meeting, Cape Town, South Africa

Massimo Massi Benedetti (UNIPG) attended the meeting to publicise the BIRO Collaboration.

13th December 2006

4th meeting of the Task Force on Major and Chronic Diseases, DG-SANCO, Luxembourg

Fabrizio Carinci (UNIPG) attended the meeting and presented the BIRO project to the Task Force (“The role of BIRO Project in the implementation of the Diabetes EU Policy Recommendations”, http://ec.europa.eu/health/ph_information/implement/wp/morbidity/docs/ev_20061213_co09_en.pdf)

3-6th October 2007

European Health Forum 2007, Gastein, Austria

Fabrizio Carinci (UNIPG) attended the meeting (expenses covered by external funds). Over 100 copies of the BIRO brochure 2007 have been distributed

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4.2 Articles published, press coverage, development web sites, etc. Date and Type Details

April 2006. BIRO Website www.biro-project.eu

Details under WP14: “dissemination”

May 2006. BIRO Forum biro-project.eu:8080/forum/forums/list.page

Details under WP 14: “dissemination”

July 2006. BIRO abstract at IDF World Conference biro-project.eu/documents/downloads/Poster.pdf

The BIRO Collaborators, Best Information through Regional Outcomes: a European Network to enhance monitoring of quality and outcomes in diabetes care, International Diabetes Federation Meeting, Cape Town, December 2006. Accepted as porter presentation.

September 2006. BIRO Brochure biro-project.eu/documents/downloads/Brochure.pdf

Over 200 brochures distributed at different international meetings (see meeting section). Over 1000 BIRO brochure printed for distribution at future national and international meetings.

March 2007. BIRO Newsletter n.1 biro-project.eu/documents/Newsletter/Newsletter%201.pdf

Featuring achievements of 2006 meetings (Perugia, Dundee, Malta) and presentation of the Tayside Diabetes Network (UNIDUND)

May 2007. Conference Abstract, 33rd Romanian National Diabetes Conference, 16-19 May 2007, Bucharest, Romania biro-project.eu/documents/downloads/beck07.pdf

P. Beck, P. Perner (Austria), S. Pruna (România), S. Cunningham (Scotland), P. Palladino, F. Carinci (Italy), Ensuring secure data transmission in the BIRO infrastructure for comparing international diabetes indicators, Accepted for oral presentation

May 2007. Conference Abstract, 33rd Romanian National Diabetes Conference, 16-19 May 2007, Bucharest, Romania biro-project.eu/documents/downloads/palladino07.pdf

P. Palladino, M.Orsini Federici, F.Carinci, M.Massi Benedetti (Italy), Regional register diabetes mellitus, Accepted for oral presentation

September 2007. BIRO Newsletter n.2 biro-project.eu/documents/Newsletter/Newsletter%202.pdf

Featuring the Graz meeting, Healthgate (JOANNEUM), Privacy Impact Assessment

October 2007. Updated BIRO Brochure Over 500 brochures printed. Over 100 brochures distributed at different international meetings (see meeting section).

December 2007. BIRO Newsletter n.3 biro-project.eu/documents/Newsletter/Newsletter%203.pdf

Featuring Cyprus meeting achievements, Cyprus diabetes care, reports template, Privacy Impact Assessment, Task Force on Major and Chronic Diseases

December 2007. Contribution to the European Report on Major and Chronic Diseases, DG-SANCO 2008

F.Carinci, F.Stracci, F.Storms on behalf of the BIRO and EUCID Collaborations, “Chapter 7. Diabetes”

January 2008. Conference Abstract accepted, Diabetes UK Annual Professional Conference, 5-7th March 2008, Glasgow, Scotland, UK

S.Cunningham on behalf of the BIRO Consortium: “Best Information through Regional Outcomes: Defining a European Diabetes Data Dictionary”. Accepted as poster presentation

This report was produced by a contractor for Health & Consumer Protection Directorate General and represents the views of thecontractor or author. These views have not been adopted or in any way approved by the Commission and do not necessarilyrepresent the view of the Commission or the Directorate General for Health and Consumer Protection. The EuropeanCommission does not guarantee the accuracy of the data included in this study, nor does it accept responsibility for any use madethereof.