First Interim Technical Implementation Report

Agreement number : 2003131

Project acronym : EURO-PERISTAT

Project title : A comprehensive health information and knowledge system for evaluating and monitoring perinatal health in Europe

Reporting period for the progress report: 15/12/2004-15/12/2005

1 PROJECT PARTICIPANTS

Names Institution, Country

Gérard BRÉART (project leader) AP-HP - Assistance Publique-Hôpitaux de Paris

Paris, France

Jennifer ZEITLIN (Scientific INSERM U-149 - Institut national de la santé et de la recherche coordinator) médicale

Béatrice BLONDEL Paris, France

Marie-Hélène BOUVIER-COLLE

Meg ZIMBECK

Sophie ALEXANDER ULB - Université libre de Bruxelles, Ecole de santé publique

Brussels, Belgium

Henrique BARROS FMUP - Faculdade de Medicina do Porto

Porto, Portugal

Istvan BERBIK HSOG - Hungarian Society of Obstetrics and Gynecology

Esztergom, Hungary

Peter HLAVA UZIS - Ustav zdravotnickych informacii a statistiky

Bratislava, Slovakia

Simone BUITENDIJK TNO - Institute Prevention and Health

Leiden, the Netherlands

Christine CANS SCPE Registers, University Joseph Fourier Grenoble 1

Grenoble, France

Mika GISSLER STAKES - National Research and Development Centre for Welfare and Health

Finland

Alison MACFARLANE CITYU - Institute of Health Sciences, City University

London, UK

Ziva NOVAK ANTOLIC SLV - Department of Perinatalogy, Division of Obstetrics and Gynecology, University Medical Centre

Ljubljana, Slovenia

2 Christian VUTUC MUW - Medical University of Vienna, Department of Epidemiology, Centre of Public Health

Viena, Austria

Pavlos PAVLOU MOH - Health Monitoring Unit, Ministry of Health

Nicosia, Cyprus

Petr Velebil UPMD - Institute for Care of Mother and Child

Prague, Czech Republic

Jens LANGHOFF ROOS RIGIT - Obstetrics Clinic, Rigshospitalet, Københavns University

Copenhagen, Denmark

Luule SAKKEUS SoM - Ministry of Social Affairs, Department of Health

Tallinn, Estonia

Nicolas LACK BAQ - Bavarian Working Group for Quality

Munich, Germany

Aris ANTSAKLIS NUA - Athens University, Department of Ob/Gyn

Athens, Greece

Sheelagh BONHAM ESRI - Economic and Social Research Institute, National Perinatal Reporting Scheme

Dublin, Ireland

Marina CUTTINI OPBG - Unità di Epidemiologia, Ospedale Pediatrico Bambino Gesù

Rome, Italy

Inese BIRZULE LSIC - Health Statistics and Medical Technology State Agency

Riga, Latvia

Aldona GAIŽAUSKIENĖ VSMTA - Lithuanian Health Information Centre, WHO Collaborating Centre for Health Statistics and Information

Vilius, Lithuania

Yolande WAGENER MS - Ministry of Health, Department of Health,

Division of Preventive and Social Medicine

Luxembourg

3 Miriam GATT DHI - Department of Health Information,

National Obstetric Information Systems (NOIS) Register

Guardamangia, Malta

Lorentz IRGENS MBRN - University of Bergen, Medical Birth Registry of Norway

Bergen, Norway

Katarzyna SZAMOTULSKA NRIMC - National Research Institute of Mother and Child,

Department of Epidemiology

Warsaw, Poland

Francisco BOLÚMAR UMH - Miguel Hernandez University, Department of Public Health

San Juan, Spain

Gunilla LINDMARK IMCH - International Maternal & Child Health Unit, Department of Women's and Children's Health, Uppsala University

Uppsala, Sweden

Vicki McMANUS EIC - Enable Ireland Cork

Cork, Ireland

Audrone PRASAUSKIENE Kaunas Child Development Clinic Lopselis

Kaunas, Lithuania

4

FIRST INTERIM TECHNICAL IMPLEMENTATION REPORT

Table of Contents

1. OVERVIEW OF PROGRESS DURING THE REPORTING PERIOD...... 6 1.1. Main accomplishments with respect to project objectives ...... 6 1.1.1 Objective 1: Integrate the new member states...... 6 1.1.2. Objective 2: Establish new indicators ...... 7 1.1.3 Objective 3: Develop methods for compiling high quality indicators and use them to collect data ...... 7 1.1.4 Objective 4: Design a reporting methodology and produce a reproductive health report ...... 8 1.2. Summary of progress on the individual work packages ...... 9 1.3. Update of progress indicators ...... 11 1.4. Difficulties encountered in carrying out work...... 12 2. CONTRIBUTION OF THE PARTICIPANTS...... 13 2.1. Main Partner: AP-HP (Project Leader), France...... 13 2.2. Associated partner 1: INSERM U149 (Scientific coordinator), France ...... 14 2.3. Associated partner 8: STAKES (National Research and Development Centre for Welfare and Health, Finland)...... 21 2.4. Associated Partner 2: SCPE-UJF (University Joseph Fourier Grenoble 1)...... 22 2.5. Associated partner 5: ULB. (Université libre de Bruxelles, Ecole de santé publique, Belgium)...... 24 2.6. Associated partner 4: CITYU (Institute of Health Sciences, City University, London, UK) ...... 25 2.7. Associated partner 3: TNO-pg Institute Prevention and Health Leiden, the Netherlands ...... 26 2.8. Associated partner 7: UZIS (Institute Health Information and Statistics (IHIS), Ustav zdravotnickych informacii a statistiky, Slovakia) ...... 27 2.9. Steering committee members not responsible for a work package...... 28 2.10. Scientific committee members from new member states and Norway...... 28 2.11. Scientific committee members from old member states...... 30 3. PROJECT MANAGEMENT AND CO-ORDINATION ...... 31

4. ANNEX...... 33

5

1. OVERVIEW OF PROGRESS DURING THE REPORTING PERIOD

The EURO-PERISTAT project aims to complete the development of a strategy for monitoring and evaluating perinatal health in the European Union. Perinatal indicators include maternal, fetal and infant health during pregnancy, delivery and the postpartum period, as well as the health consequences of events that occur in the perinatal period. They also measure demographic, medical, social and health system factors that impact perinatal health. The project has two principal focuses:

1. Establish mechanisms to compile and to report on the perinatal health indicators recommended for immediate implementation by the PERISTAT project, including adapting them to the health context in new member states. These will focus on improving data quality, extending the scope of data collection systems, building collaborations between data providers, proposing data collection methods for countries that do not have available data and developing protocols for compiling, transmitting and disseminating data.

2. Conduct the technical scientific work on the health indicators identified by PERISTAT for future development to make recommendations for a comprehensive indicator set encompassing more fully the essential dimensions of perinatal health and to support the collection of data on these indicators.

Four specific objectives were defined:

(1) integrate the new member states;

(2) establish new indicators;

(3) develop methods for compiling high quality indicators

(4) design a reporting methodology.

1.1. Main accomplishments with respect to project objectives

The plans for this reporting period and principal accomplishments with respect to these 4 objectives are presented below. More detail for each accomplishment is provided in the summary of the work packages (1.2) and in the report provided by the participant responsible for the activity (section 3).

1.1.1 Objective 1: Integrate the new member states

Objectives for reporting period:

Conduct a consensus process with scientists from the new member states to adapt the PERISTAT indicator list to the health context in these countries, and assess the feasibility of collecting indicators through a survey of national data providers. This work for this objective is contained in WP2.

Principal accomplishments:

6 The EURO-PERISTAT committees were expanded to include participants from new member states. EURO-PERISTAT now includes an official partner (Scientific Committee) as well as other scientific advisors (Scientific Advisory Group) from each EU member state.

The Steering Committee met with partners from new member states in Bratislava to present the project, assess new member state data collection systems and explain the consensus methodology to be used for making modifications to the indicators.

A DELPHI consensus process was used to adapt the PERISTAT indicator list to reflect the health context of new member states Two rounds were completed with excellent response rates. The final results are being circulated to members and the final report should be ready by the end of February (see Annex for the results and instruments from these two rounds).

Members from the new members states provided assessments of the feasibility of the PERISTAT indicators both at the meeting in Bratislava (reports from members included in Annex) and explicitly in the DELPHI survey. A synthesis of these reports is planned for the EURO-PERISTAT congress in Porto in June 2006.

1.1.2. Objective 2: Establish new indicators

Objectives for reporting period:

This objective comprises the technical scientific work to develop, pilot and implement new indicators of: (1) Neonatal morbidity and longer-term impairments of perinatal origin, such as cerebral palsy (2) Morbidity in women during pregnancy, delivery and the postpartum period (3) Positive indicators of outcome of pregnancy (4) Perinatal health in socially excluded groups. In the first year, the aim was to set up expert groups and begin the background literature and consultation work about appropriate indicators. The work on this objective is contained in WP3, WP4, WP5, and WP6.

Principal accomplishments:

Working groups that include members of the Scientific Committee, Scientific Advisory Group and external experts have been set up for each of these four WPs.

As part of the work on developing new indicators, and in particular WP3 and WP6, EURO- PERISTAT actively participated in the meeting of the European Perinatal Epidemiology Network in Siena in August 2005. A round table session was held on routine data collection to follow-up high risk babies with 5 experts in this field. This meeting also included presentations by the DG- funded National Statistics Socio-economic Classification project, as well as explorations of available data on migration and perinatal health (see Annex for minutes of meeting).

Each working group has begun background literature reviews and has produced a schedule for meetings with their scientific panels. Within the WP on neonatal morbidity and long term consequences of perinatal events, the SCPE network has continued work developing tools for collecting comparable high quality data on cerebral palsy in Europe.

1.1.3 Objective 3: Develop methods for compiling high quality indicators and use them to collect data

Objectives for reporting period:

7 The main aim is to develop methods for routine compilation of high-quality perinatal health indicators by assessing existing methods for improving data quality used in member states, specifying a minimum dataset, proposing data collection methods for countries that do not have data available and linking with European morbidity registers. In this reporting period, the aims were to start the association with morbidity registers, continue to analyze data from the PERISTAT feasibility study to assess the quality of available data and to consult with data providers about innovative methods to improve quality. In the first year it was also necessary to plan for the data collection exercise.

Principal accomplishments:

EURO-PERISTAT expanded to include registers as part of the work package coordinated by Christine CANS, coordinator of SCPE, the European network of cerebral palsy registers. Helen Dolk from EUROCAT is also part of our scientific advisory group. A review was undertaken to assess the possiblities of integrating EURO-PERISTAT recommendations with registers. A survey of CP registers is assessing the availability of denominator data and changes needed to harmonise items collected in registers with EURO-PERISTAT recommendations. An analysis of health outcomes on multiple births using data from registers and routine data bases is in progress.

Analysis of perinatal health in Europe using data from PERISTAT has continued. An article on twins in the EU has been accepted for publication in the European Journal of Obstetrics and Gynaecology. This article uses PERISTAT data to highlight the very large differences between EU countries in management of twins and to assess the impact on preterm birth. Further research on twins combines PERISTAT data with data from registers to look at health outcomes. Analyses on intervention during labor and delivery are on-going.

A project to assess differences in health outcomes due to principal risk factors among childbearing women in Europe was elaborated by TNO and the INSERM team. This analysis which will be based on further exploration of 2000 will identify mortality differences between groups based on materal age, multiple pregnancy, parity for all births and births excluding lethal congenital anomalies. The results of this analysis will be used to decide whether mortality data should be collected by new sub-groups (such as maternal age) to improve interpretation of differences between countries.

1.1.4 Objective 4: Design a reporting methodology and produce a reproductive health report

Objectives for reporting period:

Consult with target groups, including health policy makers, consumer groups, and health professionals to assess their understanding and needs with respect to information on reproductive health and health services in the perinatal period. This consultation process will inform a reporting methodology for periodic health reports that will be used to report on perinatal health.

Principal accomplishments

A survey of the literature related to evidence-based decision-making was completed by INSERM, as well as a review of documents to identify potential users of perinatal health data at the European level and within each EU member state. Additional information about potential users will be collected in a survey of project partners in early 2006. In addition, INSERM conducted in-depth semi-structured interviews with 9 informants in 7 countries regarding the use of perinatal health

8 data in policy-making. Information collected in these interviews is being used to develop a structured survey instrument to assess the needs for perinatal health information among different types of users in all EU member states. These users will be sampled from those identified in the literature and from a survey of project partners. Insights gained from these different methods will be presented in Porto in June 2006, and will accompany a policy panel featuring several high-level European policymakers and researchers. The planning for this panel was conducted in collaboration with STAKES in Finland and FMUP in Portugal in late 2005 and early 2006.

1.2. Summary of progress on the individual work packages

Work Name of work package Partner Progress during period Update package responsible provided on p.* of report WP1 Project coordination and AP-HP - Constitution of Scientific p. 13 management Committee with representation from all members states and Norway, as well as a Scientific Advisory Group with other contributing members

- Coordination of communication between partners and work packages

- Oversight and management of project planning chart and work in progress.

- Development of an internal website using a Yahoo group for internal communication and posting project documents.

- Planning and coordination of meetings

WP2 Integrating the new STAKES - Meeting with new members p. 21, 28 member states states in Bratislava, Slovakia

- Two-round DELPHI consensus process to revise indicators

- Preliminary assessemnt of feasibility

WP3 Indicators of neonatal SPCE-UJF - Revision of tools for collecting p. 14, 22 morbidity and longer- high quality, comparable data on term impairments Cerebral Palsy (CP)

- Meeting with CP registers that are part of SCPE

- Establishment of a working group for recommendations on neonatal morbidity and follow-

9 up

- Background review and analysis of follow-up studies

- Round-table organized on follow-up in European meeting of perinatal epidemiologists in Siena, Italy

WP4 Indicators of maternal INSERM - Constitution of group of experts p. 17 morbidity during pregnancy, delivery and - Background review on available the postpartum period indicators on maternal morbidity

- Meeting of working group planned for June 2006 to coincide with Porto meeting

WP5 Positive indicators of the CITYU - Constitution of group of experts p. 26 outcome of pregnancy - Review of definitions of ‘normal birth’

- Links established with the European Midwives Association

- Assessment of current surveys on women’s experiences of maternity care in Europe

- A meeting of this working group is scheduled for June 2006 as part of conference on ‘normal birth’ in England

WP6 Inequalities in outcomes ULB - Literature search on indicators of p. 24 of pregnancy and social inequality and social exclusion exclusion: indicators and data sources - Identification of key resource people in European countries and constitution of group of experts

- Meeting of working group planned for June 2006 to coincide with Porto meeting

WP7 Develop methods for INSERM - On-going analyses of p. 7, 19 routine compilation and PERISTAT data transmission of heatlh indicators - Work begun on protocol for next data collection exercise

- Data providers workshop planned for June 2006 in Porto to highlight innovative methods for providing high-quality data

10 WP8 Formalize links between SPCE-UJF - Assessment of data in registers p. 23 routine data providers and in EURO-PERISTAT and population-based morbidity registers - Survey of CP registers with respect to denominator data

- Analysis of multiple births using register and routine data

WP9 Collect data to construct TNO - Data collection planned for p. 27 and analyse PERISTAT September of 2006 indicators. Produce sets of indicator tables - Data providers workshop in Porto planned to introduce instruments and get feedback before data collection begins

WP10 Develop a reporting INSERM - Background review of literature p. 14 methodology and on using data for decision produce a report from making tables produced in WP6 - Semi-structured interviews with 9 informants from 7 countries

- Potential users of perinatal health information identified from a review of literature; this mapping exercise to be supplemented by information collected from project partners in a structured survey to be administered in early 2006.

WP11 Dissemination AP-HP - Project newsletter disseminated p. 13, 14 among partners and interested groups in December 2005

- Information about the Porto conference distributed to health professionals interested in perinatal health statistics.

1.3. Update of progress indicators

In the technical annex, 16 progress indicators were defined to monitor the project. These are reported below with an assessment of the achievements during the reporting period.

Progress indicator Achievements during reporting period 1 Finalised list of participants in Scientific Committee 9 Accomplished (including new member states) and Scientific Advisory Group; attribution of national specialists to working groups on new indicators. 2 Steering committee meetings (1 alone and 4 combined with 9 2 steering committee other project meetings) meetings held 3 Meeting with panel from new member states 9 Accomplished

11 4 Reports on assessment of feasibility of PERISTAT indicators 9 Accomplished in new member states and identification of data providers (10 – 1 per country) 5 Workshop of data providers and scientific committee ⇒ Planned for year 2 6 Meetings of working groups on new indicators (4 meetings) ⇒ Work begun; most meetings are planned for year 2 7 Meetings of the European Network of Cerebral Palsy 9 1 meeting held during Registers, including one joint meeting with representatives reporting period from population-based morbidity registers (2 meetings) 8 Site visits to countries developing cerebral palsy registers and ⇒ Planned for year 2 accompanying reports (10) 9 Site visits for meetings with specialists and accompanying ⇒ Begun in period, most reports (10) planned for year 2 10 Production of background reviews for WP2 to WP6 (6 ⇒ Begun in period, completion reports) in year 2 11 Development of instruments for informant surveys, DELPHI 9 Delphi survey designed and processes, and collection of routine data for project objectives implemented as specified in WP2, WP7, WP8, WP9 ⇒ Design of data collection instrument begun ⇒ Data collection planned for October 2006 12 Revised training manuals for the SCPE network 9 Accomplished 13 Data transmission protocols, for routine data providers and for ⇒ Design work on protocols has cerebral palsy registers begun 14 Updated web-site, with modified indicator list and data ⇒ Planned for year 2 collection recommendations 15 Publication with modified indicator list and with ⇒ List incorporating new recommendations on methods from WP7 member states is nearly complete. The modified list will be presented at the meeting in Porto 16 Report containing tables on perinatal health indicators for ⇒ Data collection planned for 2004 (or most recent year) 2006, report planned for year 3 17 Published articles in the international and national scientific ⇒ Planned for year 3 press

1.4. Difficulties encountered in carrying out work

The main problem encountered in this period was in the amendment of the contract to include new participants. The original contract was signed with the members of the Steering Committee and 16 other yet unnamed participants. After identifying the representative from each country, we proceded to amend the contract.

This process took much longer than expected. Our financial officer, Steffen Zenner, explained that our contract had been randomly selected for audit in Brussels. As a result, the contract was only signed in February of 2006.

However, Scientific Committee members – especially those from the new member states – incurred costs during this period.

For the meeting in Bratislava, the coordinator AP-HP paid for travel, but each SC member was responsible for their own subsistence. When this financing arrangement was set up, we expected the contract to be signed and funds transfered by October. Because of the delay, no money has yet been transfered to our partners.

12 These costs are declared on this cost statement, as they were incurred in this period and are known exactly.

2. CONTRIBUTION OF THE PARTICIPANTS

The following details the contributions of project participants. All participants involved directly in managing work packages have provided individual reports. We report collectively on (1) Steering Committee members that are not directly involved in managing work packages (2) Scientific Committee members from new member states and Norway who participated in objective 1, but that are not responsible for a work package and not on the Steering Committee (3) Scientific Committee members from old member states.

At the end of each report, the implications of the work accomplished for the budget are summarized in a box. Deviations from the budget, as planned in the contract, and other comments on the financial statements are highlighted.

2.1. Main Partner: AP-HP (Project Leader), France

The main partner is responsible for managing coordinating and overseeing the project and disseminating its results (WP1, WP11). The project leader is G. Bréart, medical professor at Assistance Publique-Hôpitaux de Paris (AP-HP) and head of the INSERM epidemiological research unit on perinatal and women’s health (U149).

During the reporting period, the partner focused primarily on:

Æ Establishing the EURO-PERISTAT Scientific Committee and Scientific Advisory Group with representatives from all EU member states. This involved (1) identifying data providers and perinatal health professionals with an expertise in perinatal health in the member states that were not part of the first signed contract, (2) organising the contractual association between these individuals and the EURO-PERISTAT project.

Æ Ensuring coordination and communication between the members of the EURO-PERISTAT Steering Committee, Scientific Committee, and Scientific Advisory Group. An internal web site was set up to distribute information, routine project updates were given, and a newsletter was developed and distributed to project partners and interested parties in December 2005.

Æ Overseeing the project work and coordinating between the different work packages. This component involved getting regular updates from the WP coordinators, preparing the Steering Committee meetings and updating the project work plans. Organizing the work to be done at the Porto conference, which will be the principal project meeting, is part of this overall task.

Æ Managing the administration of the project. This project includes 30 associated beneficiaries and therefore has been very complicated to manage. To illustrate this, over 1100 emails have been received and sent as part of the effort to manage information relating to the signing of the contract and amendments, the transfer of funds, the planning of meetings, and for this interim report. This communication was conducted primarily in English, and is therefore time-consuming for many project partners.

Remarks relevant to costs in the period

13 Personnel:

• Costs in this period include the inputs of the project leader and the project administration staff, as well as a part-time research coordinator who worked with the project and an administrator to manage the administrative aspects of the project.

Travel/Subsistence: Other costs covered attendance at meetings for the AP-HP members as well as other project members who had not yet received their funds. The coordinator paid for the first Steering Committee meeting and the travel (but not subsistence) of the Scientific Committee participants from new member states to the meeting in Bratislava.

2.2. Associated partner 1: INSERM U149 (Scientific coordinator), France

INSERM is responsible for the component on morbidity and long-term follow up in WP3, work on WP7 and work on WP10.

Report for WP3 – morbidity and follow-up

In this reporting period, the component of the WP3 working on developing indicators for neonatal morbidity and longer-term follow-up of high risk babies has focused on developing recommendations for assessing longer term consequences of perinatal events though the implementation of routine follow-up of high risk babies. Work on the indicators of neonatal morbidity will begin in the second period. The work on neonatal morbidity will also take into account the results from the DELPHI in the new members states.

1. Review of studies on follow-up of high risk babies: a meta-analysis of approaches

Our first aim was to understand how follow-up of high risk babies is organized in European and other industrialized countries. We made the assumption that effective follow-up programs would publish their results for the scientific community. A review of the literature was also considered an important first step as recommended indicators for follow-up should yield information that could be compared with previous data on high risk babies for the assement of trends and geographic comparisons.

A literature review was carried out to identify follow-up studies of babies using a Medline search with a selected set of keywords. The bibliographies of the articles identified in this search were reviewed to see if other articles would be included in the review.

More than 80 studies have been included in this review. For each study, we have abstracted information about the definition of the population, the timing of the follow-up period. These data have been computerized to allow a meta-analysis of methodological approaches.

The next steps are:

14 a. Send the list of studies to our panel of experts (see below) to identify other research that we might have overlooked. b. Complete abstraction of new studies c. Finalize analysis tables (see Annex) d. Case studies of successful routine follow-up studies identified in review

2. Meetings with perinatal health professionals with expertise in follow-up of high risk births

Our second aim was to bring together European perinatal health professionals with expertise in the follow-up of high riks babies to discuss key issues in developping indicators for routine follow-up of high risk births. (Asterix indicates that part of the cost of the travel of the participant was covered by the EURO-PERISTAT project – see cost statement for INSERM) a. Round-table at the EPEN meeting

Five people were invited to participate in a round table (detailed minutes are in Annex *)

• Neil Marlow, Professor of Neonatal Medicine, Academic Division of Child Health. Queen's Medical Centre, Nottingham. Professor Marlow was involved with the EPICURE study (follow-up of babies born at <26 weeks of gestation) in the UK and is starting another follow-up project EPICURE2 shortly. • Maria Cuttini, Unit of Epidemiology, Ospedale Pediatrico Bambino Gesù, Rome. Dr. Cuttini is currently carrying out a research programme involving follow-up of very preterm babies. She was also coordinator of 2 European research projects on ethical decision-making with respect to very preterm babies. • ** Elizabeth Draper, Senior Research Fellow, Department of Epidemiology and Public Health, University of Leicester, Leicester. Dr. Draper is director of the Trent Neonatal Survey, a routine data system for babies admitted for neonatal care in the Trent region. She has carried out a randomized control trials on follow-up procedures. • Martin de Kleine, Neonatologisch Centrum, Máxima Medisch Centrum, Veldhoven. Dr de Klein was responsible for analyzing follow-up data on a cohort of preterm babies in the Netherlands • ** Beatrice Larroque, Researcher, INSERM, Villejuif. Béatrice Larroque is the coordinator of the EPIPAGE study, a follow-up study of all babies born before 33 weeks of gestation in 9 regions of France. These babies are now in their 8/9th year.

With this group, we first identified a set of key themes that were each assigned to one of the participants. The key themes were: considerations for routine follow-up (Neil Marlow), defining the population to follow-up (Marina Cuttini), Control groups (Elizabeth Draper), Outcome measures (Martin de Kleine) and loss to follow-up (Béatrice Larroque). Each participant gave a brief presentation highlighting the major points with respect to his or her theme, followed by discussion.

This round table made it possible to identify key unresolved issues surrounding routine follow-up and to plan the next steps of this work package. b. Separate meetings in London and Brussels

15 The following people were interviewed with respect to this work package. These people are involved in follow-up of a cohort of very preterm babies born in 2003, as part of the European MOSAIC study, using a simplified instrument sent to parents (see instrument in appendix). Experiences with this follow-up instrument and the results of this test will be of interest for this work group.

* Dr. Tom Weber, Obstetrician, Denmark * Dr. Alan Fenton, Neonatologist, UK * Dr. Elisabeth Draper, Perinatal epidemiologist, UK * Dr. Stavros Petrou, Economist specializing in perinatal health costs • Professor Patrick Van Reempts, Neonatologist, Belgium • Dr. Janusz Mazela, Neonatologist, Poland • Dr. Guy Martens, Director of SPE (Flanders data collection on births), Belgium • Mr Bjorn Misselwitz, Epidemiologist, BAQ (perinatal health information system), Hesse, Germany

Conclusions from consultations & round table in first period :

1. Routine follow-up of very preterm births is essential for individual babies and can also provide essential information for assessing clinical practices and health outcomes for very preterm babies on a population level. One ways of encouraging follow-up of babies in general is to organize routine follow-up programs from the neonatal unit in which the baby received his or her care. 2. A distinction will probably need to be made between routine follow-up and research projects in relation to the types of information that can be collected and the choice of control groups. In research projects, it is feasible to follow-up term babies to constitute a control; this will probably difficult to implement in routine follow-up programs. However, other comparative data on the population of babies could exist. This possibility needs to be explored when a program is put into place. 3. Loss to follow-up is a key problem. Those who are lost to follow-up in routine systems and research differ with respect to social characteristics. 4. The possiblity of linking with registers should be assessed. 5. It will be important to provide health and economic rationale to sell follow-up programs to policy makers. However, in many countries, there is increasingly policy interest in having access to data on childhood impairments of perinatal origin.

Proposals for action in year 2

It would be helpful to propose a minimum data set for follow-up. The discussion of a mimumum dataset should begin with the Oxford recommended follow-up at 2 years. A consultation process should be organized, first within the panel and then more broadly.

Further follow-up is necessary later and the age for this should be 5 years of age.

Our group members optimistically felt that there was probably significant agreement among researchers about the key items to include in a mimumum dataset and on the advisability of selecting 2 and 5 years as the two key assessment periods. This needs to be tested in the assessment round.

16 Next steps:

1. Develop a consultation instrument to request feedback about mimimum dataset and ages at follow-up. 2. Create a panel of experts (several from each country) who would look over and comment. People who have run successful routine follow-up studies or have worked on follow-up studies in European countries will be invited to participate in this panel. 3. Information from the review of studies could be provided to this panel for comment. 4. Data protection and consent issues should be explored also in this panel.

Time line for completion of work package

February 1. Send out list of studies to members of group for comment 2. Identify any new studies and abstract them March 3. Develop instrument for consultation in collaboration with expert group 4. Constitute list of people who could participate in panel 5. Create database of studies and make analysis tables April 6. Consultation with panel – request for information May 7. Analysis of responses 8. Preparation of presentation at Porto – June-July 9. Revise & einalize recommendations 10. Circulate recommendations within SAG SC of EURO-PERISTAT September EURO-PERISTAT recommendations complete

Work Package 4 – Indicators of maternal morbidity during pregnancy, delivery and the postpartum period.

This component of EURO-PERISTAT aims to conduct the scientific work necessary to propose definitions when they do not exist and collect data and validate data sources for indicators that EURO-PERISTAT defined. Data for indicators of maternal morbidity will be drawn primarily from hospital data, and collaborations will be necessary with other European projects on hospital data.

At project meetings in Paris and Bratislava, work package leader Marie Hélène Bouvier-Colle presented information about WP 4 and recruited experts to participate in a working group. Experts from nine countries have been recruited, and we are continuing to recruit additional experts as they are identified in our review of the literature. The list of current working group members is included below.

This review was launched in 2005 and a first round of analysis has been completed. Additional literature will be reviewed and analyzed in the early months of 2006, and will be summarized for consideration by working group members. This report will be circulated in working group members in early spring. The proposed structure of this initial report contains 4 sections:

1) Rationale for creating an indicator of maternal morbidity

17 2) Review of definitions identified in the literature

3) Presentation of the main methodologies with results

4) Questions for members of the maternal morbidity group to move forward.

In addition, we have taken the preliminary action of reviewing the PMSI, the French system of recording the medical data in public and private hospitals, to investigate what sort of information could be easily extracted in order to evaluate maternal morbidity.

The main work of this WP 4 will be conducted in 2006, with experts considering literature and debating proposed definitions by email and in person at the Porto conference in June, 2006.

Working Group to Develop Indicators of Maternal Morbidity (WP 4)

NAME Email COUNTRY ALEXANDER Sophie [email protected] Belgium BARROS Henrique [email protected] Portugal BOLÚMAR Francisco [email protected] Spain BOUVIER-COLLE Marie Hélène [email protected] France CANS Christine [email protected] France CHAZAN Bogdan [email protected] Poland DEFOORT Paul [email protected] Belgium GALEA Ray [email protected] Malta KUENZEL Wolfgang [email protected] Germany LANGHOFF ROOS Jens [email protected] Denmark LINDMARK Gunilla [email protected] Sweden NOVAK-ANTOLIC Ziva [email protected] Slovenia SZAMOTULSKA Katarzyna [email protected] Poland TAMMEMäE Lee [email protected] Estonia UNZEITIG Vit [email protected] Czech Republic VELEBIL Petr [email protected] Czech Republic VUTUC Christian [email protected] Austria ZHANG Weihong [email protected] Belgium

Report for WP7

In this reporting period, work on WP7 entailed further analysis of existing PERISTAT data aiming to propose methods for improving quality and use of indicators of perinatal health. Work on multiple births (article in press) as well as analysis of the quality of gestational age data was carried out on the database constituted from the PERISTAT feasibility study. A project to carry out analyses of risk factors in order to explain differences in mortality between European countries was elaborated and will be completed in the first 6 months of 2006 (see TNO).

Work also began on the elaboration of a data compilation and transmission protocol with TNO for the data collectin exercize which will begin in September of 2006. Proposals for this process will be presented at a workshop organized at the EURO-PERISTAT congress in Porto in June 2006.

18 A large meeting is organized bringing together the EURO-PERISTAT steering committee, the scientific advisory group, data providers and other interested persons in Porto on the 2nd and 3rd of June 2006. More than 75 people have already confirmed attendance at this congress.

One of the main aims of this congress is to generate knowledge and ideas about how to improve the quality of routine perinatal health data. Participants are submitting abstracts for oral presentations and posters on their experiences improving data quality (deadline is the 15th of February). Poster sessions and one session of oral presentations will be held on this theme.

Report for WP-10

This work package will achieve the following results: y To design a reporting methodology to target key audiences y To use this methodology to produce a comprehensive report

In 2005, INSERM developed a plan for WP 10 that includes three phases:

1) Mapping Users of Perinatal Health Information y Conducting background review to identify target audiences y Collecting information from partners about our target audience in each country 2) Developing a Methodology for Reporting Perinatal Health Information y Conducting literature review on Evidence in Decision-Making y Collecting information regarding users’ needs for perinatal health information 3) Implementing a Mechanism for Reporting Perinatal Health Information y Developing a dissemination strategy for each target audience, including a timeline and templates for information products y Implementing dissemination strategy

Work Completed in 2005:

9 Mapping: Conducted review to identify target audiences at the European level

9 Methodology: Interviewed key policy informants to identify target audiences and gather background information to inform a structured survey to be distributed among target audiences. List of interviews is attached.

Work Planned for 2006:

y Mapping: Identify target audiences within countries by distributing a survey among all Scientific Committee members (in 26 countries) in February, 2006.

y Methodology: Information regarding users’ needs for perinatal health information will be collected using a structured survey in March/April, 2006. This survey will be distributed among users identified through the mapping process by our Scientific Committee members. Users will also validate our “map” by adding additional users/audience members within their country. In addition to this survey, we are considering conducting a small number of in-depth case studies to investigate the various factors that influence the way in which health information is used to inform policy in different European nations.

19

Work Planned for 2007:

y The development and implementation of the dissemination strategy will take place in 2007, as will the production of our report.

INTERVIEWS WITH KEY POLICY INFORMANTS

Austria 1. Christian Vutuc, The Medical University of Vienna, member of Committee on Maternal & Child Health for the Ministry of Health

France 2. Gérard Bréart, INSERM & AP-HP, member of panel who developed Perinatal Health Plan for Ministry of Health

Finland 3. Mika Gissler, STAKES, Finnish contact for WHO, OECD, EUROSTAT, REPROSTAT, PERISTAT

Germany 4. Wolfgang Künzel, University of Giessen, President German section of International Association for Maternal and Neonatal Health 5. Nicolas Lack, Bayerische Arbeitsgemeinschaft für Qualitätssicherung (BAQ-Quality Assurance), Munich

Netherlands 6. Simone Buitendijk, TNO Institute Prevention and Health, Division of Child Health 7. Jan Nijhuis, University of Maastricht, President of the Dutch Association for Obstetrics & Gynecology

Portugal 8. Henrique Barros, University of Porto Medical School, National Coodinator for HIV/AIDS infection (Ministry of Health)

United Kingdom 9. Nicolas Drey, Researcher at CityU, London

Remarks relevant to costs in the period

Personnel: • 85 days by Jennifer Zeitlin for scientific coordination and work related to WP 3 and WP 7. • 109.41 days by Meagan Zimbeck for overall project coordination and coordination of WP 10. • 13.32 days by research assistant responsible for literature review on high risk births, Nina Wilson. • 12 days by Béatrice Blondel for work as Steering Committee member and Scientific Committee member from France, including review of contract and

20 coordination of supporting documents, meetings in Paris and Bratislava, and review of DELPHI instrument. • 11 days by Marie Hélène Bouvier-Colle for work as Steering Committee member and coordinator of WP 4, including meetings in Paris and Bratislava, and review of DELPHI instrument.

Travel/subsistence: Costs included travel to project meetings (Bratislava and Siena) as well as the travel of experts contributing to WP3. There was no travel for the Steering Committee meeting, as this was held in Paris.

*Note that INSERM only declares costs already mandated. Some of costs made in period have not been mandated and do not appear on this year’s cost statement. These costs will be declared in the following period.

2.3. Associated partner 8: STAKES (National Research and Development Centre for Welfare and Health, Finland)

WP2 – Integrating the new member states PROGRESS REPORT: a. An expert panel from the new member states, including representatives of the perinatal health professions (obstetricians, neonatologists, midwives) as well as data providers was established in February-June 2005. This panel includes two representatives from each country, one clinician and one statistician or epidemiologist. b. The information on existing recommendations on perinatal health indicators in new member states has been collected in August-October 2005. c. A DELPHI consensus process with the panel of experts to assess the applicability of PERISTAT indicators was started in a meeting in Bratislava, Slovak Republic 23-24 September 2005. The panel was invited to make modifications in the exiting perinatal indicator list in the 2 following steps, which were conducted in September-October 2005 and December 2005. . d. The feasibility of collecting the PERISTAT indicators was asked from the national data providers during the first DELPHI round.

Deliverables: • A set of recommended perinatal health indicators reflecting health needs in the 25 member states of the European Union and endorsed by perinatal health professionals in all countries is in the finalisation stage.

• Identification of data providers for perinatal health indicators in new member states has been done.

• An assessment of the feasibility of implementing the PERISTAT indicator set with available data has been done preliminarily, but will be done more carefully in the data collection phase (TNO).

21

Remarks relevant to costs in the period

Personnel: • 24 days by Mika Gissler, Scientific Committee member and coordinator of Work Package 2 • 40 days by Joanna McCormack to develop, administer, and analyse two rounds of the DELPHI survey • 5 days by administrator

Travel: Costs for Ms. McCormack to meet with Scientific Coordinator in Paris, review documents from the DELPHI conducted during the first PERISTAT project, and to develop a plan for analysis. Travel costs for both Mika Gissler and Ms. McCormack to travel to Paris for the Steering Committee meeting, and to Bratislava where they helped to lead the meeting with new member states.

2.4. Associated Partner 2: SCPE-UJF (University Joseph Fourier Grenoble 1)

WP3 - Indicators of neonatal morbidity and longer-term impairments

Cerebral Palsy (CP) occurs in 1.5 to 2 per 1000 live births. It is one of the commonest disabling condition in childhood, and was recommended by PERISTAT as a long term perinatal indicator which requires future development. At present time there are 14 different CP registers in 8 different European countries, most of these registers being located in Northern countries of Europe (3 in UK, 2 in Ireland, 1 in Denmark, 1 in Sweden, 1 in Norway). There is a need to implement other CP registers in countries from South part of Europe (Spain, Portugal) and from Eastern part of Europe (Lithuania, Latvia, Slovenia, Hungary…). CP is an umbrella term and difficulties can arise because of differences in case definition, in the inclusion and exclusion criteria used by surveys and registers, and in the classification systems. The SCPE network did some standardisation and harmonisation work during the six previous years, through concerted actions funded by EC. This work allowed to pool together CP cases from different registers in a common database of more than 10 000 CP cases born 1976-1996. This work was presented to new SCPE partners during a plenary meeting in Copenhagen in June 2005. In particular several SCPE "tools" were presented and discussed:

- the SCPE Guideline for submitting CP cases to the common database, which need to be up-dated, since a few items were dropped, and a few others added after discussion. It is planned to proceed to the increment of the database in 2006 (children born 1997-1998) through an electronic data submission tool.

- the standardised SCPE Data Collection Form which can be used by registers , and has to be considered as the minimal common core of items to be collected.

- the SCPE Reference and Training Manual (CD-RoM), which contains video pieces of children with CP, and is available now in 6 different languages, English, German, Spanish, Italian, Slovenian, Lithuanian and French. This Manual will be updated with the addition of the MRI results observed in the CP children. It will be translated in Dutch also.

22 The SCPE web site has been re-organised in order to allow the possibility of having questionnaire directly on the website when needed. Its address is http://www-rheop.ujf- grenoble.fr/scpe2/site_scpe/.

During the year 2006 it is planned to have several visits to new centres: Spain, Slovenia, Lithuania, Latvia, Portugal . All these visits will be done before our SCPE plenary meeting which will be hold in Lithuania in October 2006.

WP8 - Formalise links between routine data providers and population-based registers

The main aim of this work package is to optimise the efforts performed in different networks regarding the data collection and data analysis of perinatal indicators. The final purpose will be to elaborate recommendations.

Some perinatal indicators recommended by PERISTAT are exactly the same information searched by the CP or CA registers, for instance number of multiple live births per gestational age, when calculating specific rates of CP or CA per 1000 live births and thus looking for available denominator data. The availability of such denominators, as well as the information about trends over time in such perinatal indicators are extremely important when analysing prevalence rates of cerebral palsy and their differences between countries and/or overtime.

Firstly a review was done comparing the perinatal indicators (items) recommended by PERISTAT, and collected by population based registers, such as EUROCAT (network of congenital anomalies registers) & SCPE (network of Cerebral Palsy registers). The aim was to check if the proposed perinatal items were common and had the same definition, and also to plan if other new items could be collected easily. This review on perinatal items was presented during the plenary meeting in Copenhagen, and some differences were highlighted, e.g. data per gender required in register and not in PERISTAT. In October 2005 a questionnaire was sent to each CP register to assess the availability and difficulties in getting perinatal information, in particular at a regional level which is the most common "unit" of the population based registers. At present time 14 out of 16 centres already answered to this questionnaire.

Another task of this work package is to share the information between perinatal networks by analysing the health outcomes of multiple pregnancies using different data sources, i.e.:

- the PERISTAT data (1998-2000 birth years),

- the EUROCAT data (1980-2000 birth years),

- the SCPE data (1980-1996 birth years).

Since 1980 the rate of multiple births increased in the whole population, it nearly doubled up to 3 %, the prevalence rate of multiple births with CA increased from 6 per 10000 live births to 8 per 10000 live births, whilst the CP prevalence rate in multiple remained steady around 8 per 1000 live births. It is planned to present detailed results of this analysis and its public health impact during the plenary meeting of EURO-PERISTAT in June 2006.

Remarks relevant to costs in the period

23 Personnel: • 30 days for Christine Cans, scientific leader, for coordination of Work Packages 3 and 8, and participation as Steering Committee member in meetings in Paris and Bratislava. • 36 days for research coordinator • 25 days for statistician • 14 days for computer technician • 6 days for administrator

Travel: • Travel costs for 3 SCPE register members to attend a meeting in Copenhagen • Travel for one SCPE member to attend a meeting in Gotenberg

Other Costs: • Costs related to the development and printing of a SCPE Reference and Training Manual

2.5. Associated partner 5: ULB. (Université libre de Bruxelles, Ecole de santé publique, Belgium)

Composition of team:

Sophie Alexander is a member of the project Steering Group. Wei-Hong Zhang is a member of the project team.

Activities:

The school of Public Health, ULB is in charge of the Work Package 6: Inequalities in outcomes of pregnancy and social exclusion: indicators and data sources.

During the reporting period, the following activities were carried out:

9 Literature search on inequalities and social exclusion in the health of mothers and babies in the perinatal period.

9 Participation in EURO-PERISTAT-II project meetings:

• First Steering Committee Meeting held in Paris, February 09 2005

• Meeting with the new EU member states held in Bratislava 23-24 September 2005

The following activities are ongoing and will continue:

⇒ Identification of key resource people in European countries, who can contribute to this topic and describe the situation in their country, including policies, targeted interventions, and a description of the extent of social exclusion.

⇒ Identification and composition of working group members (see list of proposition).

24 ⇒ 1st meeting of the Belgian working group scheduled February 2006

⇒ Preparation of the meeting experts which will be hold in Porto, in June 2006

⇒ Update of literature search, including official reports and grey literature on inequalities and social exclusion in the health of mothers and babies in the perinatal period

Remarks relevant to costs in the period

Personnel: • 20 days Sophie Alexander for coordination of Work Package 6 and work as Steering Committee and Scientific Committee member from Belgium, reviewing documents and providing supporting documentation for contract and this report, and attending Steering Committee meetings in Paris and Bratislava.

Travel: • Travel and subsistence to Bratislava for Sophie Alexander and Wei-Hong Zhang, who will be working on WP6 in 2006.

Other Costs: • Book "Atlas des langues" & "Atlas des migrations" for the literature review

2.6. Associated partner 4: CITYU (Institute of Health Sciences, City University, London, UK)

City university is responsible for the Work Package 5, which has 3 components:

• ‘Normal birth statistics’ which can be derived from routinely collected data

• Information about the role of midwives in the countries of Europe.

• Information about women’s experiences of maternity care.

Alison Macfarlane attended the first Steering Committee meeting in Paris in February 2005. Prior and subsequent to the meeting she identified work that had been done relevant to the three components of the study.

Nick Drey joined on the project on 1st November 2005 and had completed 20 days work on the project up until 14/12/05. Both he and Alison Macfarlane attended the meeting for the new member states in Bratislava in September 2005. Preliminary arrangements have been made to hold a meeting of the Work Package working group on Tuesday June 6 in Grange over Sands, England, immediately before the beginning of the international conference on normal birth, organised by the University of Central Lancashire.

25 Subsequently they hosted a one day meeting in London for key data providers from each of the four countries of the United Kingdom. As England, Scotland, Wales and Northern Ireland each have separate statistical systems, the overall aim of the meeting was to discuss how their data could be harmonised. This is both to derive pooled data for use within the United Kingdom and for submission to Peristat data collections.

Progress on each component of the Work Package is as follows:

1. ‘Normal birth’ statistics:

We have assembled a working group for the work package and reviewed possible definitions of ‘normal birth’. Normal birth statistics for the countries of UK, and the definitions used to construct them have been identified. The meeting with UK data providers included a discussion on the availability of ‘normal birth’ data in the UK.

2. Role of midwives

We have established a link with Marianne Mead, who is a member of the Executive Board of the European Midwives Association, and is piloting a survey of the role of midwives in European countries

3. Women’s experience of birth and maternity care

Alison Macfarlane has discussed the project with Maggie Redshaw and Beatrice Blondel, who have been commissioned to do surveys of women’s experiences of maternity care in England and France, respectively. Researchers in other European countries who are either undteraking surveys or interested in this aspect of the work package have been identified.

Remarks relevant to costs in the period

Personnel: • 10 days by Alison Macfarlane, Steering Committee and Scientific Committee member, for coordination of this work package, review of project documents, coordination of documents for the contract and for this report, attendance at meetings in Paris, Siena, and Bratislava. • 20 days by Nicolas Drey for work in support of this work package. • 1 day administrator

Travel: • Travel and subsistence to Bratislava Alison Macfarlane and Nicolas Drey

2.7. Associated partner 3: TNO-pg Institute Prevention and Health Leiden, the Netherlands

The majority of work for this package will be conducted in year 2. However, in the first year of the project the following activities were completed:

26 • April 29th, first meeting with Scientific Coordinator Jennifer Zeitlin to discuss Dutch part in the EURO- PERISTAT project • 23-24 September 2005, meeting in Bratislava with new member states • Onset of preparation of additional analysis to study differences in perinatal mortality between countries planned in 2006 • Onset of preparation for the data-collection planned in the second half of 2006

Remarks relevant to costs in the period

Personnel: • 7.5 days by Karin van der Pal as Scientific Leader and coordinator of this work package. • .5 days by administrator

Travel: • Travel and Subsistence for Karin van der Pal to attend the Bratislava meeting as representative for TNO. • Other?

2.8. Associated partner 7: UZIS (Institute Health Information and Statistics (IHIS), Ustav zdravotnickych informacii a statistiky, Slovakia)

For Work Package 2, UZIS was responsible for organising and hosting the meeting of new member states in Bratislava, Slovakia in September 2005. For all participants, UZIS made hotel arrangements and provided detailed travel information. Arrangements for a meeting space and refreshments were made, and a dinner for participants was hosted on the first night of the meeting. The budget for UZIS included funds to support the travel and subsistence of Scientific Advisory Group (SAG) members from new member states who attended the meeting. These members were reimbursed directly for their subsistence at the meeting, and travel expenses for all SAG members except Cyprus were reimbursed following the meetings. Travel for the Cyprus SAG member was purchased by AP-HP, at the same time that travel for the Cyprus Scientific Committee member was bought.

As a Steering Committee member, UZIS attended the first Steering Committee meeting in Paris in February 2005. As a new member state, UZIS participated in the two-round DELPHI consensus process to adapt the PERISTAT indicators.

Remarks relevant to costs in the period

Personnel: • 36 days by Scientific Leader Peter Hlava for coordination of the Bratislava meeting and participation in the DELPHI process

27 • 28 days by Renata Lenharčíková for administration

Travel: • The Steering Committee meeting in Paris in February 2005 was attended by Renata Lenharčíková • Travel and subsistence were provided for 9 Scientific Advisory Group members attending the Bratislava meeting

Other Costs: • Costs for the meeting space for 2 days, including a separate venue for the Steering Committee, and for translation, technical support, refreshments, documents, and a meal for participants totalled 3414.50 euros.

2.9. Steering committee members not responsible for a work package

--Department of Perinatalogy, Division of Obstetrics and Gynecology, University Medical Centre Ljubljana, SLOVENIA– established in Slovenia

--HSOG, Hungarian Society of Obstetrics and Gynecology – established in Hungary

These two scientific committee members attended the Paris Steering Committee meeting and the meeting of new member states and adjoining Steering Committee meeting in Bratislava. They also participated in the DELPHI process and prepared reports on perinatal health indicators in their countries.

Remarks relevant to costs in the period Personnel: • 22 days by Ziva Novak-Antolic, Steering Committee and Scientific Committee member from Slovenia for attending the Paris and Bratislava meetings, and participating in the DELPHI consensus process. • 22 days by Istvan Berbik, Steering Committee and Scientific Committee member from Hungary for attending the Paris and Bratislava meetings, and participating in the DELPHI consensus process.

Travel: • Travel for Slovenian and Hungarian members to attend the Paris meeting was funded by AP-HP. • Slovenia and Hungary used funds budgeted to their institutions to pay for their own travel and subsistence to the Bratislava meeting.

2.10. Scientific committee members from new member states and Norway

These Scientific Committee members reviewed documents and provided supporting documentation related to the signing of the contract and this report. They participated in a two-round DELPHI consensus process to adapt the PERISTAT indicators to their

28 countries, and (except for Norway) attended a meeting in Bratislava where they presented information about their perinatal information systems and the feasibility of collecting PERISTAT indicators.

Remarks relevant to costs in the period

Personnel: • 15 days by Pavlos Pavlou, Steering Committee and Scientific Committee member from Cyprus for attending the Bratislava meeting, and participating in the DELPHI consensus process. • 15 days by Petr Velebil, Steering Committee and Scientific Committee member from Czech Republic for attending the Bratislava meeting, and participating in the DELPHI consensus process. • 15 days by Luule Sakkeus, Steering Committee and Scientific Committee member from Estonia for attending the Bratislava meeting, and participating in the DELPHI consensus process. • 15 days by Inese Birzule, Steering Committee and Scientific Committee member from Latvia for attending the Bratislava meeting, and participating in the DELPHI consensus process. • 15 days by Aldona Gaizauskiene, Steering Committee and Scientific Committee member from Lithuania for attending the Bratislava meeting, and participating in the DELPHI consensus process. • 17 days by Miriam Gatt, Steering Committee and Scientific Committee member from Malta for participating in the DELPHI consensus process, and her substitute Kathleen England for participating in the Bratislava meeting. • 15 days by Katerzyna Szamotulska Steering Committee and Scientific Committee member from Poland for attending the Bratislava meeting, and participating in the DELPHI consensus process. • 11 days by Lorentz IRGENS for participating in the DELPHI consensus process. Irgens was not able to attend the Bratislava meeting.

Travel: • Except for the Norway member, who did not attend the Bratislava meeting, travel for all new member state Scientific Committee members to the Bratislava meeting was paid by AP-HP. However, these members paid for their own subsistence using funds provided to their institutions for this purpose. Travel was paid by AP-HP because the amended contract had not yet been signed by DG-SANCO and thus funds for travel could not be transferred to these members in advance of the Bratislava meeting. To ensure a successful meeting and prevent financial hardship for these new member state institutions, funds from the AP-HP budget were used and then the budget was amended to reflect this change. Because of the delay in signing this contract, these members have still not been transferred any funds that would enable individual members to be reimbursed for their subsistence expenses, but this transfer is planned for February 2006.

29 2.11. Scientific committee members from old member states

Scientific Committee members from old member states read project documents and material relating to working groups, responded to requests from Working Group leaders, and submitted supporting documentation for the signing of the contract and for this interim report. In 2006, these members will attend the meeting in Porto, participate in working groups to develop new indicators, provide information for WP 10 about potential users of perinatal health information in their countries, and facilitate the data collection on PERISTAT indicators in their countries.

Remarks relevant to costs in the period

Personnel • 3 days for Scientific Committee members from Austria, Denmark, Germany, Greece, Ireland, Italy, Spain and Sweden. 6 days for the SCPE member from Ireland, and 5 days for the SCPE member from Lithuania. Travel • No travel for these members during the reporting period

30 3. PROJECT MANAGEMENT AND CO-ORDINATION

Outline major project co-ordination activities during the period

Meetings

Meetings Location Participants

1 Steering committee meeting 1 Paris Gérard Bréart Claire-Francoise Birckel Jennifer Zeitlin Meg Zimbeck Béatrice Blondel Marie-Hélène Bouvier-Colle Alison McFarlane Henrique Barros István Berbik Christine Cans Živa Novak-Antolič Mika Gissler Joanna McCormack Sophie Alexander Wei-Hong Zhang Renata Lenharcikova

2 Meeting with new member states Bratislava Sophie Alexander Wei-Hong Zhang Steering committee meeting 2 Pavlos Pavlou Andreas Hadjidemetriou Petr Velebil Vit Unzeitig Luule Sakkeus Lee Tammamäe Mika Gissler Joanna McCormack Jennifer Zeitlin Meg Zimbeck Marie-Hélène Bouvier-Colle Béatrice Blondel Christine Cans István Berbik Inese Birzule Ilze Kreicberga Aldona Gaizauskiene Nijole Vezbergiene Kathleen England Raymond Galea Karin van der Pal-de Bruin Katarzyna Szamotulska Bogdan Chazan Henrique Barros Peter Hlava Fratisek Bauer Renata Lenharcíková Ziva Novak-Antolic

31 Ivan Verdenik Alison Macfarlane Nicolas Drey

3 Meeting on follow-up of high risk births Siena Meg Zimbeck and migrant women’s perinatal health Béatrice Blondel Béatrice Larroque

4. SCPE meeting Copenhagen BECKUNG Eva KRÄGELOH-MANN Inge MC MANUS Vicki

5. SCPE meeting Gotenberg PLATT Mary Jane

Communication

- Development of an internal website using Yahoo groups. This website enables members to have access to key project documents, including the contract, related publications, profiles of partners, information related to meetings, and working group updates.

- Development of a newsletter. The first issue of our Project Update newsletter was published and disseminated in December 2005 (see Annex). We plan to disseminated a quarterly newsletter 4 times per year, with the next issue planned for March 2006.

- The external PERISTAT website will be updated during the next reporting period. Design work has already begun and will continue to be informed by the results of Work Package 10, to ensure consistency with the project reporting methodology.

32 4. ANNEX

a. Complete list of participants in the EURO-PERISTAT project (Steering Committee, Scientific Committee, and Scientific Advisory Group members)

b. Document describing EURO-PERISTAT project

c. Documents from EURO-PERISTAT Meetings

i. Steering committee meeting in Paris

ii. Meeting in Bratislava

iii. Summary of Round table on follow-up of high risk births at the European Perinatal Epidemiologist Network meeting in Siena

iv. Summary of session on migrant women’s perinatal health at the European Perinatal Epidemiologist Network meeting in Siena

d. Reports on data collection systems, Bratislava

e. DELPHI questionnaires and results from both rounds

f. EURO-PERISTAT newsletter, December 2005

g. Flyer for Porto meeting & abstract submission form

h. Project for analysis of risk factors

33 STEERING COMMITTEE

PROJECT COORDINATION Sophie ALEXANDER Henrique BARROS Belgium Portugal

Jennifer ZEITLIN Université Libre de Bruxelles University of Porto Medical School of Public Health School, Department of Hygiene and Scientific Coordinator Reproductive Health Unit Epidemiology

Institut national de la santé et de la Route de Lennik 808, CP 597 4200-319 Porto, Portugal recherche médicale (INSERM) U149 B-1070 Bruxelles, Belgique Tel: +351 225507597 123 Boulevard Port Royal Tel: +32 2 555 4063 or 4079 Mobile : +9 6 622 6709 75014 Paris, France Fax: +32 2 555 4049 Fax : +351 225095618 Tel: +33 1 42 34 55 79 [email protected] [email protected] Fax: +33 1 43 26 89 79 [email protected] Marie Hélène BOUVIER-COLLE István BERBIK France Hungary

Meg ZIMBECK Institut national de la santé Department of Obstetrics and Project Coordinator et de la recherche médicale Gynaecology, Vaszary Kolos (INSERM) U149 Teaching Hospital Institut national de la santé et de la recherche médicale (INSERM) U149 123 Bld Port Royal Esztergom Pf POB 18 Tel: +33 1 42 34 55 74 75014 Paris, France Hungary H-2500 Fax: +33 1 43 26 89 79 Tel: +33 1 42 34 55 72 Tel: +36 33 542338 [email protected] Fax: +33 1 43 26 89 79 Fax: +36 33 542338 [email protected] [email protected]

Béatrice BLONDEL Simone BUITENDIJK Gérard BREART France the Netherlands Project Leader Institut national de la santé TNO Institute Prevention and Health, Assistance Hôpiteax et de la recherche médicale Division of Child Health Publique de Paris and (INSERM) U149 Institut national de la santé et de la Wassenaarseweg 56. recherche médicale (INSERM) U149 16, avenue Paul Vaillant-Couturier PO Box 2215. Tel: +33 1 42 34 55 70 94807 Villejuif Cedex, France 2301 CE Leiden, the Netherlands Fax: +33 1 43 26 89 79 Tel : +33 1 45 59 50 96 Tel: +31 71 51 81 16 71 [email protected] Fax : +33 1 45 59 50 89 Fax: +31 71 51 81 19 15 [email protected] [email protected]

Claire-Francoise BIRCKEL Christine CANS Mika GISSLER Project Administrator France Finland

Assistance Hôpiteax Publique de Paris Service d'Information et d'Informatique National Research and Development Pôle Affaires européennes Médicale (SIIM) Centre for Welfare and Health Direction de la politique médicale 1 avenue Claude Vellefaux Pôle Exploitation PL 220 (Lintulahdenkuja 4) F-75010 Paris, France Pavillon Taillefer - CHU de Grenoble 00531 Helsinki, Finland Tel : +33 1 44 84 17 68 BP217 - 38043 Grenoble Cedex 09 Tel. +358 9 3967 2279 Fax: +33 1 44 84 17 88 Tel: +33 4 76 76 94 03 Fax. +358 9 3967 2324 [email protected] Fax: +33 4 76 76 52 02 [email protected] [email protected] Peter HLAVA Alison MACFARLANE Ziva NOVAK-ANTOLIC the Slovak Republic the United Kingdom Slovenia

Institute of Health Information City University, University Medical Centre and Statistics (UZIS) Department of Midwifery Perinatology Unit

Drienová 34, P.O. Box 75 24 Chiswell Street Zaloska 11 820 09 Bratislava, Slovak Republic London EC1Y 4TY 1000 Ljubljana, Slovenia Tel (1): + 421 2 43412087 Tel : +44 207 040 5832 Tel (1): +386 1 522 6000 Tel (2): +421 2 43412086 Fax : +44 20 7505 5866 Tel (2): +386 1 522 6020 Fax: + 421 2 43412095 [email protected] Fax: +386 1 43 97 590 [email protected] [email protected]

34 SCIENTIFIC COMMITTEE

Austria - Österreich Belgium – Belgique/België Christian VUTUC Sophie ALEXANDER

The Medical University of Vienna, Université Libre de Bruxelles Department of Epidemiology, Centre of Public Health School of Public Health Abteilung für Epidemiologie Zentrum für Public Health Reproductive Health Unit der Medizinische Universität Wien Route de Lennik 808, CP 597 Borschkegasse 8a B-1070 Bruxelles, Belgique A-1090 Vienna, Austria Tel: +32 2 555 4063 or 4079 Tel: +43 1 4277 65180 Fax: +32 2 555 4049 Fax: +43 1 4277 65198 [email protected] [email protected] Cyprus - Kypros Czech Republic - Česká republika Pavlos PAVLOU Peter VELEBIL

Ministry of Health, Health Monitoring Unit Institute for the Care of Mother and Child υπουργείο υγείας Ustav pro peci o matku a dite

Markou Drakou 10 Podolske nabrezi 157 1448 Nicosia, Cyprus 14700 Prague 4, Czech Republic Tel: +357 22 557125 Tel: +420 296 511 815 Fax: +357 22 557127 [email protected] [email protected] Denmark/Danmark Estonia - Eesti Jens LANGHOFF ROOS Luule SAKKEUS

Obstetrics Clinic, Rigshospitalet, Københavns University Ministry of Social Affairs, Department of Health Obstetrisk klinik, Rigshospitalet, Københavns Universitet Eesti vabariigi Sotsiaalministeerium

Blegdamsvej 9 Gonsiori 29 DK 2100 Copenhagen Ø EE - 15027 Tallinn, Estonia Tel: +45 35451371 or +45 35454310 Tel: +372 6269 161 Fax: +45 35 45 4471 Fax:+372 6992 209 [email protected] [email protected] Finland - Suomi France Mika GISSLER Béatrice BLONDEL

National Research and Development Institute of Health and Medical Research U149 Centre for Welfare and Health Institut national de la santé et de la recherche médicale Päällikkö StakesTieto 16, avenue Paul Vaillant-Couturier PL 220 (Lintulahdenkuja 4) 94807 Villejuif Cedex, France 00531 Helsinki, Finland Tel : +33 1 45 59 50 96 Tel. +358 9 3967 2279 Fax : +33 1 45 59 50 89 Fax. +358 9 3967 2324 [email protected] [email protected] Germany - Deutschland Greece - Ελλάδα Nicholas LACK Aris ANTSAKLIS

Bavarian Working Group for Quality Assurance Athens University, Department of Ob/Gyn Bayerische Arbeitsgemeinschaft für Qualitätssicherung Πανεπιστηµίου Αθηνών

Westenriederstrasse 19 11 Lampsakou Street 80331 München, Germany 11528 Athens, Greece Fax: +49 89 211 590 20 Tel: +30 201 770 8749 [email protected] Fax: +30 201 771 9271 [email protected]

35 SCIENTIFIC COMMITTEE

Hungary - Magyarország Ireland István BERBIK Sheelagh BONHAM

Hungarian Society of Obstetrics and Gynecology and Economic and Social Research Institute Vaszary Kolos Teaching Hospital, National Perinatal Reporting Scheme Department of Obstetrics and Gynecology Vaszary Kolos Kórház 4 Burlington Road Dublin 4, Ireland Esztergom Pf POB 18 Tel: +353 1 6307191 Hungary H-2500 Fax:+353 1 6686231 Tel: +36 33 542338 [email protected] Fax: +36 33 542338 [email protected] Italy - Italia Latvia - Latvija Marina CUTTINI Inese BIRZULE

Pediatric Hospital of Baby Jesus Health Statistics and Medical Technology State Agency Unit of Epidemiology Veselības statistikas un medicīnas Unità di Epidemiologia tehnoloģiju valsts aģentūras Ospedale Pediatrico Bambino Gesù 12/22 Duntes street Piazza S.Onofrio 4 Riga, Latvia 1005 00165 Roma Tel: +371 7 501 580. Tel: +39 06 68592856 [email protected] Fax : +39 06 68592853 [email protected] Lithuania - Lietuva Luxembourg Aldona GAIŽAUSKIENĖ Yolande WAGENER

Lithuanian Health Information Centre, WHO Collaborating Ministry of Health, Department of Health, Centre for Health Statistics and Information Division of Preventive and Social Medicine Lietuvos sveikatos informacijos centras Ministère de la Santé, Direction de la Santé, Division de la Médecine Préventive et Sociale Kalvariju 153, LT-08221 Vilnius, Lithuania Villa Louvigny Tel: +370-5-2773301 L-2120 Luxembourg Fax: +370-5-2773302 Tel: +352 4785544 Mobile: 370 686 95450 Fax: +352 467527 [email protected] [email protected] Malta Netherlands - Nederland Miriam GATT Simone BUITENDIJK

Department of Health Information, TNO Institute Prevention and Health, National Obstetric Information Systems (NOIS) Register Division of Child Health Dipartiment ta’ l-Informazzjoni fuq is-Saħħa TNO-Preventie en Gezondheid Sistema Nazzjonali ta’ Informazzjoni dwar l-Ostettriċja Wassenaarseweg 56, PO Box 2215 95, Telgħa ta’ Guardamangia, 2301 CE Leiden, the Netherlands Guardamangia MSD 08, MALTA Tel: +31 71 51 81 16 71 Tel: +356 25599000 Fax: +31 71 51 81 19 15 Fax: +356 25599385 [email protected] [email protected]

36 SCIENTIFIC COMMITTEE

Norway - Norge Poland - Polska Lorentz IRGENS Katarzyna SZAMOTULSKA

University of Bergen, Medical Birth Registry of Norway National Research Institute of Mother and Child, Universitetet i Bergen, Medisinsk fødselsregister Department of Epidemiology Instytut Matki i Dziecka, Zakład Epidemiologii Kalfarveien 31 NO-5018 Bergen, Norway ul. Kasprzaka 17a Tel: +47 5 597 46 67 01-211 Warsaw, Poland Fax: +47 5 597 49 98 Tel/Fax : +48 22 3277325 [email protected] Mobile: +48 608 420 311 [email protected] Portugal Slovakia – Slovensko Henrique BARROS Peter HLAVA

University of Porto Medical School Institute of Health Information and Statistics Department of Hygiene and Epidemiology Ústav zdravotníckych informácií a štatistiky (UZIS) Serviço de Higiene e Epidemiologia Faculdade de Medicina do Porto Drienová 34, P.O. Box 75 820 09 Bratislava, Slovak Republic 4200-319 Porto, Portugal Tel (1): + 421 2 43412087 Tel: +351 225507597 / Mobile: +9 6 622 6709 Tel (2): +421 2 43412086 Fax : +351 225095618 Fax: + 421 2 43412095 [email protected] [email protected] Slovenia – Slovenija Spain - España Ziva NOVAK-ANTOLIC Francisco BOLÚMAR

University Medical Centre, Perinatology Unit Miguel Hernandez University, Department of Public Health Univerze v Ljubljani Universidad Miguel Hernandez, Departamento de Salud Publica Zaloska 11 1000 Ljubljana, Slovenia Carretera Alicante - Valencia Km. 8,7 Tel: +386 1 522 6000 03550 San Juan (Alicante) España Tel (secretary): +386 1 522 6020 Tel: +34 96 5919510 Fax: +386 1 43 97 590 Fax: +34 96 5919551 [email protected] [email protected] Sweden - Sverige United Kingdom Gunilla LINDMARK Alison MACFARLANE

International Maternal & Child Health Unit, Department of Department of Midwifery Women's and Children's Health, Uppsala University City University Internationell mödra- och barnhälsovård, Institutionen för kvinnors och barns hälsa, Uppsala Universitet 24 Chiswell Street London EC1Y 4TY 75185 Uppsala, Sweden Tel : +44 207 040 5832 Tel: +46 18 6115998 Fax : +44 20 7505 5866 Fax: +46 18 508013 [email protected] [email protected] SCPE Register Member SCPE Register Member Vicki McMANUS Audrone PRASAUSKIENE

Enable Ireland Cork Kaunas Child Development Clinic Lopselis Kauno vaiko raidos klinika Lopselis The Lavanagh Centre Ballintemple, Cork, Ireland Lopselio st. 10, Tel: +353 21 4294803 Kaunas, Lithuania Fax: +353 21 4294260 Tel: +370 7 260425 [email protected] [email protected]

37 SCIENTIFIC ADVISORY GROUP (SAG) NEW MEMBER STATES

Cyprus - Kypros Czech Republic - Česká republika Andreas HADJIDEMETRIOU Vit UNZEITIG

Neonatal Intensive Care Unit Deptartment of Obstetrics & Gynecology Arch. Makarios III Hospital Masaryk University Brno Gynekologicko-porodnická klinika E. Proestou 3 – Egouri Masarykova univerzita v Brne Nicosia 2412 Cyprus Tel : +357 22 405 333 Jihlavska 20 Fax : +357 22 666 014 CZ-62500 BRNO Czech Republic [email protected] Tel: +420 532 238 236 Fax: +420 532 238 443 [email protected] Estonia - Eesti Hungary - Magyarország Lee TAMMEMÄE István SZABÓ

Women’s Clinic Department of Obstetrics and Gynecology, East Tallinn Central Hospital University of Pécs Naistekliinik PTE ÁOK Szülészeti és Nőgyógyászati Klinika Ida-Tallinna Keskhaigla H-76 Pécs, Edesanyák Ravi 18 u. 17 Hungary Tallinn 10138, Estonia Tel : +72 536-360 Tel: 372 620 7150 Fax: +36 72 536-372 Fax : 372 620 7405 [email protected] [email protected] Latvia - Latvija Lithuania - Lietuva Ilze KREICBERGA Nijole VEZBERGIENE

Riga Maternity Hospital Vilnius University Children's Hospital Rīgas Dzemdību Nams Vilniaus universiteto vaiku ligonine

Miera Street 45 Santariskiu 7 Riga, LV 1013 Latvia LT-08406 Vilnius-21, Lithuania Tel: + 371 7011211 Tel: +370 5 2720620 Fax: + 371 7339448 Fax: +370 5 2720283 [email protected] [email protected] Malta Poland - Polska Raymond GALEA Bogdan CHAZAN

Department of Obstetrics & Gynaecolgy, St Luke's Hospital Sacred Family Hospital Dipartiment tal-Ostetrija u Ginekologija,Sptar San Luqa ul.Bruzdowa 109c Gwardamangia, Malta MSD 07 02991 Warszawa, Poland Tel: +356 21223035 Tel/Fax: +48 22 450 22 64 Fax: +356 21250544 Mobile: +48 602 305 475 [email protected] [email protected] Slovakia – Slovensko Slovenia – Slovenija Frantisek BAUER Ivan VERDENIK

Slovak Heath Univesity Department of Obstetrics & Gynecology, University Medical Center Pri hradzi 6, Klinični center Ljubljana, SPS Ginekološka klinika 940 77 Nove Zamky, Slovakia [email protected] Slajmerjeva 3 1000 Ljubljana, Slovenia Tel: + 386 1 4302805 Fax: +386 1 4397590 [email protected]

38 Project Summary The aim of the EURO-PERISTAT II project is to complete the development of a strategy for monitoring and evaluating perinatal health in the European Union. Perinatal health indicators measure maternal, fetal and infant health during pregnancy, delivery and the postpartum period, as well as the health consequences of events that occur in the perinatal period. They also measure demographic, medical, social and health system factors that impact perinatal health.

Before the work of EURO-PERISTAT began, many perinatal health indicators in the EU countries could not be compared because of important differences in definitions, data collections procedures, birth and death registration, and medical practices. In addition, key indicators for evaluating perinatal health and the quality of health services were not available in all countries.

EURO-PERISTAT I was successful in identifying 10 core and 23 recommended indicators of perinatal health and the determinants of perinatal health, and in assessing the ability of existing data collection systems to construct these indicators. These are available for review at http://europeristat.aphp.fr. To complete the development of a comprehensive health information and knowledge system for evaluating and monitoring perinatal health in Europe, EURO-PERISTAT II will focus on four key objectives: y Integrate New Member States by adapting the indicator list to their health context and assessing the feasibility of collecting these indicators y Establish New Indicators to complete a comprehensive indicator set encompassing more fully the essential dimensions of perinatal health. These will include indicators of: 1. Neonatal morbidity and longer-term impairments of perinatal origin 2. Morbidity in women during pregnancy, delivery and the postpartum period 3. Positive outcome of pregnancy 4. Perinatal health in socially excluded groups y Develop Methods for Compiling High Quality Indicators and collect data y Design a Reporting Methodology to achieves best use of data for surveillance and evaluation of health outcomes, practices and policy

In addition to a project Steering Committee, EURO-PERISTAT II is supported by a Scientific Committee in which a single participant from each member state contributes scientific expertise and coordinates all project activities within their country. In addition, a Scientific Advisory Group enables participation from a larger group of scientific experts who collaborate to develop new indicators and methods for compiling and transmitting data. EURO-PERISTAT II is part of the European Commission’s Public Health Programme, which aims to measure health status and determinants throughout the community in order to support health and social policy in the European institutions and member states.

EURO-PERISTAT II Steering Committee: J. Zeitlin and M. Zimbeck, Scientific Coordinators, U149 INSERM, Paris; G. Bréart, Project Leader, Assistance Publique-Hôpitaux de Paris; S. Alexander, Reproductive Health Unit, Université libre de Bruxelles, Brussels; H. Barros, Department of Hygiene and Epidemiology, Porto Medical School, Porto; M.H. Bouvier-Colle, U149 INSERM, Paris; I. Berbik, Hungarian Society of Obstetrics and Gynecology, Esztergom; B. Blondel, U149 INSERM, Villejuif; S. Buitendijk, Division of Child Helath, TNO Institute Prevention and Health, Leiden; C. Cans, SCPE Registers, University Joseph Fourier, Grenoble; M. Gissler, National Research and Development Centre for Welfare and Health, STAKES, Helsinki; P. Hlava, Institute Health Information and Statistics, Bratislava; A. Macfarlane, Bartholomew School of Nursing and Midwifery, City University, London; Z. Novak Antolic, Department of Perinatalogy, University Medical Centre, Ljubljana.

39 1st Steering Committee Meeting

09 February 2005, 9:00-16:00

Paris, France

PARTICIPANTS

Gérard Bréart Claire-Francoise Birckel AP-HP / INSERM Jennifer Zeitlin Meg Zimbeck Béatrice Blondel Marie-Hélène Bouvier-Colle CITYU Alison McFarlane FMUP Henrique Barros HSOG István Berbik SCPE Christine Cans SLV Živa Novak-Antolič Mika Gissler STAKES Joanna McCormack ULB Sophie Alexander Wei-Hong Zhang UZIS Renata Lenharcikova

MEMBERS ABSENT TNO Simone Buitendijk UZIS Peter Hlava

MEETING SUMMARY

I. Project Overview, Jennifer Zeitlin

“ Document on website: “Project Overview & Background”

II. Budget & Administrative Aspects, Meg Zimbeck & Claire Birckel a. Budget Verificators: We have received a signed copy of all BVs, with the exception of TNO (the Netherlands) who was not in attendance. When we submit all signed BVs, we may receive our first installation of Pre-Financing from the Commission.

40 b. Overview of Financing and Project Timeline: the first installation of Pre-Financing from the Commission will be distributed to partners based on their needs (and ability to spend) in the first year. Partners who are leading a work package are asked to complete a project planning chart by March 04, estimating how and when they will spend funds over the three year project period.

“ Document on website: (Files/WP-1/Budget & Administration) “Funding by Work Package with Timeline”

“ Document on website: (Files/WP-1/Budget & Administration) “Type of Financing” c. Reimbursement and Bank Transfers: there are two ways to receive project funds through a bank transfer. Claire explained these and created a document for your reference. i. Don’t forget that you must mail your boarding passes to Claire at AP-HP as soon as possible. This is required by for AP-HP’s reimbursement procedures. To be safe, you may want to photocopy your boarding passes before mailing them. These can be sent to: Claire-Francoise BIRCKEL Assistance Publique - Hôpitaux de Paris Pôle Affaires européennes Direction de la politique médicale DRCD 1 avenue Claude Vellefaux F-75010 Paris, France

“ Document on website: (Files/WP-1/Budget & Administration) “Bank Transfers” III. Overview of Scientific Committee and Advisory Committee, Jennifer Zeitlin a. Scientific Committee: These members are contractually bound to the project. They must have enough access/authority to be able to facilitate data collection within their country. i. Old members: In PERISTAT I, there were two representatives from each member state on the Scientific Committee. PERISTAT II, there will be only one representative from each state. Jennifer Zeitlin/INSERM will send a letter to each PERISTAT I committee member, informing them of the new project and asking them to select which colleague will represent their country for Peristat II. This member of the Scientific Committee will receive funds and coordinate activities of the PERISTAT project in his/her country. This member must sign the contract and provide proof of participation and daily rate. The second person will be invited to participate in the Scientific Advisory Group. Previous (Peristat I) Scientific Committee members from countries that already have representation the Peristat II Scientific Committee (by a member of the Steering Committee) will instead be invited to serve on the Scientific Advisory Group.

ii. New members: New EU member states did not participate in Peristat I, and it is therefore necessary to identify potential committee members within each of the new member states. In addition, in some old EU member states, it may be necessary to find different representation for Peristat II. It was decided that we will approach the “National Competent Authority” to ask for a recommendation for potential committee members. STAKES will draft this letter, with input from INSERM. The letter will also describe our objective of adapting Peristat indicators to the new member states. Steering Committee members offered suggestions at the meeting, and may do so after the meeting by adding to a database on the Peristat website.

“ Document on website: (Database) “Potential Scientific Committee Members”

41 b. Scientific Advisory Group: This group includes members who have not signed the contract, but who provide data, commentary and advice. These members will contribute to working groups related to indicator groups, and their travel for meetings is included in these budgets.

IV. Overview of Objective 1 – Mika Gissler a. Integrating New Member States: There was general agreement that we need to focus on adapting the current set of indicators – in terms of their definitions and on identifying gaps in indicator set. Mika Gissler, with his colleague Joanna McCormick is going to be leading this working package.

b. A meeting with the members of the scientific panel (one scientific committee member and one other person – clinician or statistician from each new member country) will take place in Bratislava in September. Both the 2nd and 3rd weeks are possibilities - our Slovak partners at UZIS will let us know more soon.

“ Document on website: “WP-2: Integrating New Members States”

V. Overview of Objectives 2-4– Christine Cans, Marie-Hélène Bouvier-Colle, Alison MacFarlane, Sophie Alexander, Meg Zimbeck a. Working groups will be constituted by the leaders of work packages relating to indicators. Steering Committee members were asked to indicate their preference for participating in working groups relating to indicators of 1) neonatal morbidity, maternal morbidity, positive pregnancy, and social exclusion. Members’ ratings were compiled in a database that is available on the website. If you have not added your preference to this list, you may add your name to the database or email Meg Zimbeck at [email protected]

“ Document on website: (Database) “Priorities for Working Group Participation”

b. PowerPoint slides for each of these presentations is available on the website. “ Document on website: “WP-2: Integrating New Members States” “ Document on website: “WP-3: Indicators of Neonatal Morbidity” “ Document on website: “WP-4: Indicators of Maternal Morbidity” “ Document on website: “WP-5: Indicators of Positive Pregnancy Outcome” “ Document on website: “WP-6: Inequalities and Social Exclusion” “ Document on website: “WP-8 :Formalize Links Between Providers & Registers” “ Document on website: “WP-10:Design a Reporting Methodology”

42 Round Table on Follow-up of high risk births: scope for harmonization in Europe

EPEN Meeting Siena August 31 2005

Summary

Jennifer Zeitlin, Researcher, Coordinator of PERISTAT project, INSERM, Paris I. Overview of Session and Key Areas of Interest. a. Objective of Peristat II project - one indicator for further development is neonatal morbidity, including the longer-term impariments associated with perinatal events, such as cerebral palsy. i. work with SCPE and regional NICU networks b. MOSAIC – Models of OrganiSing Access to Intensive Care for very preterm births, a study of 10 european regional health systems, looking at differences between european regions c. Objectives of session: i. what are the key issues facing researchers working in this area: routine data collection, population to be followed up, controls, outcome measures, loss to followup. ii. What further information is necessary in order to make proposals about indicators and methods for studying and monitoring long-term outcomes. iii. Do we need European collaborative research on long-term outcomes? iv. Is there value to a european-level study beyond what a national study can do? If yes, why? If no, why do we need harmonization?

Neil Marlow, Professor of Neonatal Medicine, Academic Division of Child Health Queen's Medical Centre, Nottingham II. Is there scope for harmonization? Routine collection of follow up data. a. Disability and preterm birth: i. Neuromotor: cerebral palsy ii. Vision: blindness, myopia, squint iii. Hearing: SNHL (high tone) iv. Psychological function: cognitive impariment, language delays, attention deficit v. Other organ impairment: lungs, CVS, growth, etc. b. Harmonized routine follow-up? i. Advantages include consistency, geographic and time trends, future international studies, and providing background for investigative studies. Challenges include different health systems, agreement on group, age, dataset and definitions, central coordination but local collation and chasing. c. Cost and administration i. Each country would have a different system ii. Likely to be significant local costs iii. How to integrate perinatal data? iv. Can we compare across national boundaries? v. Data security vi. Benchmarking d. Summary

43 i. Easy to identify negatives but difficult to define benefits for the child/family, the individual neonatal services, the national neonatal organization, EPEN. e. Discussion of presentation: i. What do we get by introducing routine monitoring vs. More in-depth studies that are periodic? ii. The biggest disability that you find among premature babies is impaired cognitive ability, and this requires a developmental test at age 2 that is more formal. 1. Is there a value in using a screening tool so that the high-risk babies receive a full developmental screening (those who are likely to have a severe problem). Italy: they plan to get DSG and there is an economic incentive for each region to enter the program with a standardized form. Jennifer wants to review published studies to find..if a followup program is functioning – what are the methods (what ages, is it routine) what are successful models, unsuccessful models. Host: if you look at the performance of a screening tool, its actually very poor.

Maria Cuttini, Unit of Epidemiology, Ospedale Pediatrico Bambino Gesù, Rome III. The objectives of preterm infants follow-up. a. Different objectives may require somewhat different populations and/or sampling strategies i. Description ii. Prediction and counselling iii. Audit iv. Evaluation v. Etiologic research b. Who is eligible for follow-up? i. Genetic and chromosmal abnomolies ii. Prenatally arising conditions and/or diseases iii. Conditions arising in the peri and postnatal period iv. Pre peri and post natal interventions v. Risk factors c. Discussion – We often talk about pre-term babies because perhaps the issues or groups are easy to define. Also, you need a certain number of babies who survive in order to complete a study, and that limits looking at some gestational age or birthweight categories. It is difficult, when there is no definition of the outcome, to recognize and evaluate the development of the child. There are regional difference, there is no uniform guidelines. People are putting follow-up studies in place now, and this is the time to talk about a minimum common set of procedures. Too early to expect implementation on a national or european level of follow-up, but perhaps we can share our experiences and information to come up with a minimum set for comparability.

Elizabeth Draper, Senior Research Fellow and Director of the Trent Neonatal Survey, Department of Epidemiology and Public Health, University of Leicester, Leicester IV. Using controls for European follow-up studies a. Basic Questions i. Are controls required? It depends on the question to be answered, and the availability of data for appropriate comparison group.

44 ii. For all European countries? What is already known about outcomes across Europe? What about international varations? What’s the local relevance? iii. What type of controls? A basic rule for control selection: they should form a representative sample of the source population for the cases. Therefore, the control group depends on the question to be answered. Examples of controls include: 1. gestation specific – EPICURE II 2. random sample of births – FOCAL 3. matched - POD/IPOD; maternal age – GASTRO 4. School mate – TES/EPICURE iv. When and how should the controls be selected? 1. recruitment at birth is easiest because you can maintain contact/interest in the study to ensure high response rates 2. Other options include routine data sources, in hospital birth records, and schools v. What are the limitations? 1. feasibility – it’s not easy to set up this type of study 2. resources – time and finance, difficult to sell this to funders 3. consent – time-consuming activity trying to obtain consent 4. level of motivation of control subjects may be more difficult than maintaining motivation of cases vi. Discussion 1. sometimes the control group has a higher prevalence of disability than the general population because of volunteer bias, which is why Liz prefers selecting the controls at birth.

Martin de Kleine, Neonatologisch Centrum, Máxima Medisch Centrum, Veldhoven V. Dutch working group determined domains for follow-up at different ages a. Discussion: Is routine followup of any benefit to individual children? How expensive is it? Mika says he answers policymakers in terms of future savings. Neil says the better question is “what do you get for your money?” What is the framework for deciding if investments in survival are worth it? One of the things that politicians don’t understand is that areas that have high levels of ascertainment ultimately look worse.

Beatrice Larroque, Researcher, Coordinator of EPIPAGE study, INSERM, Villejuif VI. Lost to follow-up in very preterm studies, the Epipage study a. Loss to follow-up can bias the results of the outcome, but very little information is available to assess the political magnitude of this problem b. Differences between respondents and non-respondents: Non-respondents are younger, parity is higher, more are born outside of France, they have lower maternal education level, and have less professional activity during pregnancy. c. Reasons for non-response at 1 and 2 years postal questionnaire included dissatisfaction with medical care, being overwhelmed with care, very underprivileged social conditions, gave a false address at birth or being without papers, family violence, serious illness, absence of stable residence, or fear of institutions d. Summary: children seen without difficulty are not representative of those who are seen with difficulty. Participation strongly related with socioeconomic factors. Improvements would be to identify early those who ultimately might prove difficult

45 to follow and therefore try to maintain better contact in the interval between discharge and the followup assessment. Obtaining progress report by phone or questionnaire, send information to parents between followup points, use other sources of information for severe disability.

e. Discussion – it’s clear that we need to incorporate the socioeconomic dimension into research on follow-up, thus linking the morning and afternoon sessions at the EPEN meeting. It would be valuable to continue this discussion after today among those who are interested in discussing this further.

Conclusions

6. Routine follow-up of very preterm births is essential for individual babies and can also provide essential information for assessing clinical practices and health outcomes for very preterm babies on a population level. One ways of encouraging follow-up of babies in general is to organize routine follow-up programs from the neonatal unit in which the baby received his or her care. 7. A distinction will probably need to be made between routine follow-up and research projects in relation to the types of information that can be collected and the choice of control groups. In research projects, it is feasible to follow-up term babies to constitute a control; this will probably difficult to implement in routine follow-up programs. However, other comparative data on the population of babies could exist. This possibility needs to be explored when a program is put into place. 8. Loss to follow-up is a key problem. Those who are lost to follow-up in routine systems and research differ with respect to social characteristics.

Proposals for action :

It would be helpful to propose a minimum data set for follow-up. The discussion of a mimumum dataset should begin with the Oxford recommended follow-up at 2 years.

Further follow-up is necessary later and the age for this should be 5 years of age.

The panel members optimistically felt that there was probably significant agreement among researchers about the key items to include in a mimumum dataset and on the advisability of selecting 2 and 5 years as the two key assessment periods.

46 EURO-PERISTAT-II Second Steering Committee Meeting 24 September, 2005 Bratislava 13:00-16:00

Summary of discussions and decisions

The meeting addressed the following points:

1. Review of the meeting with the new member states and discussion of the DELPHI analysis:

There was general admiration for the data collection systems in place as well as the presentations made by the participants. There may be a lot to be learned from the systems currently in place in the new EU countries, although some of these systems are facing difficulties (Hungary, Poland). Poland in particular noted that perinatal health is losing priority as an issue in relation to other health threats because perinatal mortality rates have improved.

The presentations brought up the issue of the definitions of indicators and inclusion criteria. These should be gone through again to clearly specify if data are collected in the same manner in all countries (ie ‘terminations included in stillbirths, what happens to non-residents, etc).

Several Steering Committee members expressed surprise that the issue of data confidentiality and responses to the new EU legislation on confidentiality had not come up. We need to explicitly ask this question to the new member states, especially as it relates to their participation in EURO-PERISTAT data collection. In a future meeting, it would be good to hold a session on the issue of data confidentiality and on who has access to perinatal health data (statisticians, clinicians, others?). Perhaps one component of the data workshop in Porto could be to invite someone from the EU who worked on this legislation to explain its intent and to offer advice on how to implement it without destroying surveillance systems. We could couple this with a panel to discuss the different ways in which countries are currently implementing the legislation.

2. Organisation of the scientific advisory group (SAG):

The proposed rule for membership was accepted. The SAG should include: - All people who worked directly with the PERISTAT I project (SAC members who are not Scientific Committee members, the midwives who were part of PERISTAT I, and the data providers) and who wish to be on the list. - People involved in the EURO-PERISTAT-II work packages (including new indicators and data providers who will participate in work on methods and data collection). -Other people who make a specific request for inclusion in the PERISTAT project

The list of people on the SAG will be circulated to the members of the Steering Committee for approval. However, we need information from each of the work packages about the SAG members from their groups.

47 A newsletter describing the work of the EURO-PERISTAT project should be sent to the SAG twice a year.

These people will be invited to the meeting in Porto in June 2006.

3. Meeting in Porto in 2006:

The decision was made to hold a meeting in Porto on the 2nd and 3rd of June 2006.

The meeting will be called ‘Better Statistics for Better Health for Pregnant Women and their Babies’.

It will take place all day Friday and Saturday. Sessions on Friday morning and Saturday afternoon will be smaller working meetings within the EURO-PERISTAT project (including a steering committee meeting at the end of the day on Saturday).

The Friday afternoon and Saturday morning sessions will address a wider audience around the following themes: - Presentation of work from the EURO-PERISTAT project: o Results of the DELPHI and feasibility study in the new countries o New indicators (if results are available) o Other analyses of PERISTAT data (if completed). - Methods for improving the collection, analysis, compilation and presentation of data on perinatal health - Better statistics for better health : examples of successful use of statistics to improve the health of pregnant women and newborns

There will be oral presentations and also poster sessions.

For the themes to be addressed on the Friday afternoon and Saturday morning, we will ask for submissions for oral presentations and/or posters. The requests will be made to the SAG, the EPEN network and the perinatal health email group. We also discussed advertising the meeting in the PPE or European Journal of Obs and Gyn. A proposed ‘advertisement’ will be circulated for comment.

We will also invite members from the ‘Network of Competent Authorities’ at the EU. If there are policy makers who could contribute to the sessions on use of statistics for health policy, we can also send out invitations to attend and speak.

An updated description of the proposed meeting in Porto will be sent out shortly.

For the smaller meetings before and after the meeting, emphasis will be placed on new indicators and meetings with data providers to introduce the data collection exercise to be carried out in September 2006.

4. Miscellaneous:

Henrique Barros mentioned that different Perinatal associations are circulating a letter asking for public health to be a higher priority. He will distribute this letter by email to the group.

48

Christine Cans requested a EURO-PERISTAT letter of endorsement in support of a new CP register in Latvia. Jennifer will provide this.

5. Calendar and other logistic points:

Æ Work packages on new indicators:

Meagan will circulate the lists of people interested in working on the new working groups. By the 30th of November, we would like an update from all the working groups with the lists of members to the working groups and the work plans up until the June meeting in Porto.

Æ Work package on links between registers and routine data collection:

Christine CANS handed out a questionnaire that they propose to use to assess the current availability of routine data for the construction of indicators for registers.

The members of the Steering Committee are requested to send a copy comments to her by October 21.

Æ Work package on methods and data collection:

The next steps are to get feedback on the data collection during PERISTAT I and to ask providers if they would like to participate in further analysis.

One proposal for analysis is to look at age-adjusted mortality rates using individual based data.

A proposal was handed out by Karin van der Pal-de Bruin from TNO in the Netherlands. The Steering Committee is requested to provide comments to her and to Jennifer by October 21st.

Æ Work package on health reporting

Meg will be distributing a survey to all project partners within the next month to gather information about local, regional and national policymakers who influence Perinatal health. She will use this information to set up interviews with policymakers that will inform our reporting methodology. She raised the question of whether it would be worthwhile to have some policymakers at some portion of the Porto meeting, in order to raise visibility of these issues and build relationships. There was an agreement that it was not desirable to have policymakers attend all sessions at Porto, but perhaps to have one policy-oriented session.

Deadlines and dates

21 October Please send back comments on; y Questionnaire for registers (to Christine Cans) y Proposal for analysis on maternal age (to Karin and Jennifer)

4 November Finalize document describing meeting in Porto for circulation

49

30 November Work package leaders provide updates to Jennifer and Meg

31 December* Cost statements and progress reports (more information to follow) submitted to Jennifer and Meg to support annual report to Commission report to the commission (exact deadline to be confirmed)

15 February Deadline for submissions for Porto meeting

50 New timetable

• 9.00 Presentations from Malta, Poland, Slovakia and Slovenia • 10.00 Mika Gissler: Current perinatal health monitoring at international level • 10.30 Jennifer Zeitlin: What is Delphi? • 11.00 Mika Gissler and Joanna McCormack: How to implement Delphi method? • 12.00 End of meeting

© 2005 STAKES

Common features

• Data collection – Methods vary: registers, statistics, surveys,…, no data – Interesting and important variables missing – Variation in definitions by country and by time • Coverage – Hospital births only? – Births in private hospitals? – Residents or citizens? • Transfer of data and data linkages – Between institutions / registers? – Confidentiality and data protection questions © 2005 STAKES

Current perinatal health monitoring at international level

Mika Gissler

STAKES National Research and Development Centre for Welfare and Health

© 2005 STAKES

51 Who collects?

• EU / Eurostat New Cronos – http://epp.eurostat.cec.eu.int/ •EU / DG Sanco – http://www.europa.eu.int/comm/health/ph_information/ dissemination/echi/echi_en.htm • OECD Health Data – http://www.ecosante.org/ • WHO Health for all –database – http://www.who.dk/hfadb

© 2005 STAKES

Reproduction indicators • Number of live births [1, 2] • Number of stillbirths (inclusion criteria 1000 grams) [2] • Number of live births per 1000 women aged 15-49 years and by five-year age groups [1] • Number of induced abortions [2] • Number of induced abortions for women below 20 years and over 35 years [2] • Number of induced abortions per 1000 women aged 15-49 years • Number of induced abortions per 1000 live births [2] • Total fertility rate [2]

[1] Already collected by Eurostat [2] Already collected by WHO. © 2005 STAKES

Mortality indicators - newborns [1+2]

• Number of stillbirths per 1000 births • Number of early neonatal deaths (0-6 days) • Early neonatal mortality rate per 1000 births • Perinatal mortality rate per 1000 births • Number of late neonatal deaths (7-27 days) • Late neonatal mortality rate per 1000 live births • Neonatal mortality rate per 1000 live births • Number of post-neonatal deaths (28-364 days) • Post-neonatal mortality rate per 1000 live births • Infant mortality rate per 1000 live births

[1] Already collected by Eurostat [2] Already collected by WHO: inclusion criteria partly 1000 grams.

© 2005 STAKES

52 Mortality indicators - mothers [2]

• Number of maternal deaths, divided to direct obstetric causes and indirect obstetric causes • Maternal deaths per 100 000 live births • Maternal deaths due to direct obstetric causes per 100 000 live births • Maternal deaths due to indirect obstetric causes per 100 000 live births

[2] Already collected by WHO: inclusion criteria: during pregnancy or 0-42 days of termination of pregnancy)

© 2005 STAKES

Morbidity indicators

• Children – Number of live births weighing more than 2500 grams [2] – Incidence of low-birth weight among live births per 100 live births [2] – Number of selected congenital anomalies[1] – Number of selected congenital anomalies per 10 000 births[2] • Mothers –None

• [1] Already collected by EUROCAT and by International Clearinghouse for Birth Defects Monitoring System. • [2] Already collected by WHO

© 2005 STAKES

Health care system indicators

• Number of midwifes (employed full-time) [2] • Number of midwifes (employed full-time) per 100 000 population [2] • Incidence of Caesarean section per 1000 live births [2, 3]

[2] Already collected by WHO [3] Already collected by OECD

© 2005 STAKES

53 Problems with monitoring • Multiple data collection • Variation in indicators used and in their definitions • Underreporting – WHO and UNICEF estimates for infant mortality 2000-2002 – WHO, UNICEF and UNFPA estimates for maternal mortality 2000

© 2005 STAKES

Finnish perinatal mortality rate by different data sources 1975-1999, 1/1000 births

14

12

10

8 EU WHO 6 OECD

4

2

0 1975 1980 1985 1990 1995 2000

© 2005 STAKES

French perinatal mortality rate by different data sources 1975-1999, 1/1000 births

20 18 16 14

12 EU 10 WHO 8 OECD 6 4 2 0 1975 1980 1985 1990 1995 2000

© 2005 STAKES

54 WHO and UNICEF estimates on infant mortality rate: underreporting 50% or more

Azerbaijan

Kyrg yz st a n

Turkmenistan

Tajikistan

Kazakhstan

Armenia WHO/UNICEF Uzbekistan

Republic of Moldova Official

Albania

Georgia

Ukraine

Cyprus

San Marino

0 10203040506070

© 2005 STAKES

Romania

Russian Federation

TFYR of Macedonia

Bulgaria

Se rb ia & M ont e neg ro

La t vi a

Belarus

Moderate Hung a r y Estonia under- Li t h u a ni a Poland WHO/UNICEF reporting Croatia Official United Kingdom

Portugal 10-49% Greece Switzerland

Austria

France

Slovenia

Norway

Finland

Iceland

0 5 10 15 20 © 2005 STAKES

Turkey

Bosnia & Herzegovina

Slovakia

Ireland

Malta Under- Belgium Is r ae l

Netherlands reporting WHO/UNICEF It al y Official less than Denmark Andorra 10% Monaco Luxe mb o urg

Germany

Spain

Czech Republic

Sweden

010203040

© 2005 STAKES

55 ECHI and ICHI

• A long process to define key health indicators for Europe – ECHI: European Community Health Indicators • http://www.europa.eu.int/comm/health/ph_information/ dissemination/echi/echi_en.htm – ICHI: International Compendium of Health Indicators • http://www.healthindicators.org/

© 2005 STAKES

ECHI short list: Demographic and socio-economic factors 1. Population by gender and age 2. Age dependency ratio 3. Crude birth rate 4. Mother’s age distribution – teenage pregnancies, aged mothers 5. Fertility rate 6. Population projections 7. Total unemployment 8. Population below poverty line

© 2005 STAKES

ECHI short list: Health status

9. Life expectancy 10. Infant mortality 11. Perinatal mortality (foetal deaths plus early neonatal mortality) 12. Standardised death rates Eurostat 65 causes 13. Drug-related deaths 14. HIV/AIDS 15. Lung cancer 16. Breast cancer 17. (Low) birth weight 18. Injuries: road traffic 19. Injuries: workplace 20. Perceived general health, prevalence 21. Prevalence of any chronic illness 22. Health expectancy, based on limitation of usual activities

© 2005 STAKES

56 ECHI short list: Determinants of health

23. Regular smokers 24. Total alcohol consumption 25. Consumption/availability of fruit, excluding juice 26. Consumption/availability of vegetables, excluding potatoes and juice 27. PM10 (particulate matter) exposure

© 2005 STAKES

ECHI short list: Health interventions: health services

28. Vaccination coverage in children 29. Breast cancer screening coverage 30. Cervical cancer screening coverage 31. Hospital beds 32. Physicians employed 33. Nurses employed 34. MRI units, CT scans 35. Hospital in-patient discharges, limited diagnoses 36. Average length of stay (ALOS), limited diagnoses 37. GP utilisation 38. Surgeries: PTCA, hip, cataract 39. Expenditures on health 40. Survival rates breast, cervical cancer

© 2005 STAKES

ECHI long list

• Important user-windows – Perinatal health, child health, reproductive health • Other user-windows covers areas such as – Mental health, cancer, diabetes, cardiovascular diseases, lung diseases, musculoskeletal diseases, oral health, injuries, health of intellectually disabled, lifestyles, nutrition, environmental health, working environment, health promotion, • Cross-cutting user-windows – Health of elderly, socio-economic differences, health system performance © 2005 STAKES

57 ECHI long list and user-windows

• Parturients and deliveries • Parturients and deliveries – Distribution of parity – Severe maternal morbidity – Fertility rates – Trauma to perineum – Maternal age at 1st birth – Multiple birth rate – Mother’s age distribution – Place of birth – Education of mothers – Births by mode of delivery – Mothers by country of origin – Births without medical – HIV seroprevalence among intervention (births attended by pregnant women midwives) – HIV testing among prengant – Episiotomy women – Satisfaction of mothers with – Pregnant women smoking perinatal care – Post-partum depression – Support to women in the perinatal – Deliveries after ART period – Fecal incontinence – Very preterm births outside NICU – Problems in getting pregnant – Prenatal screening

© 2005 STAKES

ECHI long list and user-windows

• Deaths from (short-list of 65 • Newborns causes) – Apgar-score at 5 minutes – Pregnancy, childbirth and – Low-birth weight pueperium (O) – Prematurity – Conditions from perinatal –Cerebral palsy period (P) – Hypoxic-ischemic encephalopathy – Congenital anomalies (Q) – Down’s syndrome –SIDS – Neural tube defects – Breast-feeding • Mortality rates – Neonatal screening (PKU, other) – Causes of perinatal deaths –Fetalmortality • Hospitalisation rates (65 causes) – Infant mortality – Pregnancy, childbirth and – Neonatal mortality pueperium (O) – Perinatal mortality – Conditions from perinatal period – Post-neonatal mortality (P) –Maternalmortality – Congenital anomalies (Q) © 2005 STAKES

ECHI long list and user-windows

• Other reproductive health • Other reproductive health – Induced abortion rate – Contraceptive use – Sexually transmitted – Breast cancer screening diseases – Cervical cancer screening – Cancer of reproductive – Hormone replacement therapy organs – Sales of sex hormones – Perceived sexual health –Hysterectomy – Median age of first – Employed midwives intercourse – Sexual behaviour: partners and frequency – Sexual abuse and violence

© 2005 STAKES

58 Delphi process

What we expect from you?

© 2005 STAKES

Three tasks

•First, we would like to know which ten indicators of perinatal health you feel are essential parts of a European health information system. • Second, we would like your comments on the indicators that are currently in the PERISTAT indicator set. We request your comments on the definitions of these indicators and the sub-groups selected for their presentation. •Third, we would like you to tell us if there is a specific indicator which is relevant for monitoring perinatal health in your country which is not included in the current list of PERISTAT indicators.

© 2005 STAKES

Next steps

• Deadline: Please return the questionnaire by the Friday 14 October 2005 – by email to [email protected] or – by post to Joanna McCormack, STAKES, P.O. Box 220 (Lintulahdenkuja 4), 00531 Helsinki, Finland or – by fax to +358 9 3967 2497. • Next step: A second questionnaire will be sent to you in mid-November. You will be asked to give your opinion on the results of the first questionnaire.

© 2005 STAKES

59 Other tasks

• Clinical quality indicators: Please give the information for us, if there is any clinical quality indicator system • Feasibility study: January-February 2006.

© 2005 STAKES

60 DELPHI ON PERNATAL HEALTH INDICATORS with new participants in the EURO_PERISTAT-II project

Round II Results

I. Response Rate We again had an excellent response rate. The round 2 of the DELPHI consisted of two sections 1. Candidate indicators for addition to the PERISTAT list or for further work: Induced abortion, neonatal morbidity, content of perinatal care, and policy indicators as well as improving the existing indicators related to causes of death and gestational age determination 2. Modifications and clarifications to current indicator definitions.

In total, 20 out of 22 responses to the questionnaire were received. The DELPHI includes contributions from the scientific committee and scientific advisory group in the new EU member states as well as Norway which has also recently joined the EURO-PERISTAT project. Members from Hungary and Latvia submitted joint questionnaires, which are considered as two responses in analyses.

This document presents the detailed responses to the questions in the questionnaire (sections II-IV) followed by an overall summary (section V).

II. Indicators that could be added to the indicator list or for further consideration

1. Induced abortion

In total, 13 respondents (65%) agreed with adding induced abortion to the PERISTAT list, 6 respondents (30%) disagreed and 1 (5%) did not answer. Those who disagreed concluded that problems in data completeness may reduce its value as a perinatal health indicator; especially when the borderline between an induced abortion and a birth may differ by country. Thus, a late termination of pregnancy may be labelled as a birth in one country, but as an induced abortion in another country. The status of a missed abortion was also raised.

The questionnaire included two alternative labels: 1) late termination of pregnancy (20+ weeks) and 2) termination for medical reason (any timing), No consensus was reached on the label neither on the following description:

Number of induced abortions by the following gestational age groups: <20 weeks 20-21 weeks 22-23 weeks 24-27 weeks 28 weeks and later

In total, 8 respondents (40%) agreed, 8 (40%) disagreed and 4 (20%) did not answer. Few participants stated that all terminations of pregnancies after 22 weeks of gestation are defined births, according to the WHO recommendation.

61 One respondent suggested that it would be useful to have a qualitative indicator, describing in a structured way different policies and practices both to early and late abortions in European countries.

Some respondents commented about the legality of induced abortions: induced abortion is not legal in two EU countries, Ireland and Malta. Also, in Poland, induced abortion is not available for social reasons or on request, but on indications stated in the Abortion Law, such as crime, protection of maternal life, fetal reasons. The number of reported cases is very low according to the Ministry of Health.

2. Neonatal morbidity

On the question of whether the project should develop an indicator of neonatal morbidity, 15 participants (75%) agreed, 4 disagreed (20%) and 1 (5%) did not answer. The following indicators were given as candidate indicators: - Apgar score at 5 minutes - Bronchopulmonary dysplasia (BPD) - Early treatment, such as physiotherapy - Family support - Infections during neonatal period, neonatal sepsis, nosocomial infections - Intraventricular haemorrhage (IVH) - Necrotising enterocolitis (NEC) - Need for care for more than 6 days care in the third level intensive care unit - Periventricular leucomalacia - pH in umbilical vessels blood - Prevalence of severe congenital malformations at birth to indicate the morbidity that requires long-term care - Retinopathy of prematurity (ROP)

3. Content of perinatal care

In the first DELPHI round, many respondents proposed indicators that address the content of perinatal care. However, there is no clear consensus on an appropriate indicator, and it has been found to be difficult to agree on only one indicator. In total 14 respondents (70%) agreed and 6 disagreed (30%) that an indicator on content of perinatal care is a priority.

The following quantitative indicators were given as candidate indicators: - Completed standard antenatal care according to local/national rules and guidelines - Evaluation of content of prenatal health services by completion of basic tests - Genetic amniocentesis - Length of maternity leave - Number of regular visits - Percentage of very preterm births delivered in units without neonatal intensive care unit (NICU) - Timing of first prenatal visit - Ultrasonography exams: the exam at mid-term or at 20 weeks of gestation - Ultrasonography exams: timing of first exam

The following qualitative indicators were given as candidate indicators:

62 - Existence and content of the national standard of care during uncomplicated pregnancy, including timing of visits (especially of the first one), necessary examinations and tests, provision of anti-smoking and nutritional counselling - Evaluation of prenatal health services by their availability, accessibility and affordability

In addition, one respondent replied that if only one indicator has to chosen, it could be “How much of your expectations were fulfilled (from 0 to 100)? “ Apparently this indicator and its methodology need to be developed further.

4. Policy indicators

In total 17 respondents (85%) agreed and 3 respondents (15%) disagreed on an indicator on neonatal screening. All 20 respondents (100%) informed that their country has a national policy governing screening of the newborn at birth. The respondents mentioned the following screenings and screening tests:

At birth: Apgar score Body weight, body length, head and thorax circumference measurement Congenital malformations - Developmental dysplasia of the hip - Ultrasonography of coxae (third and sixth week) - Ultrasonography of kidneys - Pulsations of aa.femorales (before discharge) Neurological investigation including sensory organs - Congenital cataracta - Otoacustic emission Congenital metabolic diseases: - Galactosaemia (total galactose and Gal-1-PUT), - Hypothyreosis, - Absence of biotidinase, - Phenylketonuria, Other - Cystic fibrosis - Congenital adrenal hyperplasia - Severe hyperbilirubinaemia - Thalassemia screening - Blood group and Rh factor

III Improving the use of existing indicators

a) Finding a common cause of death classification for fetal and neonatal deaths from existing European lists

In total 19 respondents (95%) agreed and 1 (5%) disagreed that finding a common cause-of death classification for fetal and neonatal deaths is a priority. The respondents mentioned that there may be difficulties in using the WHO classification. A short and useful list should be created for comparisons between countries, regions and hospitals.

63 b) Obtaining more information on gestational age determination in each European country

In total 18 respondents (90%) agreed and 2 (10%) disagreed that obtaining more information on the different ways of determining gestational age in Europe.

Both issues should be addressed in the forthcoming indicator work at the European Union level in order to harmonise methods for compiling indicators.

IV. Proposed modifications to definitions of indicators

1. (C1-C5) Indicators including gestational age

Suggested modification: The 22 and 23 week groups should be presented separately since many countries only begin to collect data at 24 weeks of gestation.

In total 16 respondents (80%) agreed, 3 (15%) disagreed and 1 (5%) had no opinion on the modification. The respondents agreed that this modification is convenient for the countries, which do start their collection from 24 weeks of gestation. Several respondents commented, however, that countries should be advised to adopt the WHO definition of 22 weeks of gestation. One respondent further restated the WHO recommendation that international comparisons should only include stillbirths and neonates weighing 1000 grams or more or with a gestational age of 28 weeks or more.

2. (C6 and R3) Maternal mortality ratio and maternal mortality by cause of death

Current definition: The number of maternal deaths (the death of a woman while pregnant or within one year of the termination of pregnancy, irrespective of the duration and site of the pregnancy, for any cause related to or aggravated by the pregnancy or its management, but not from accidental or incidental causes) per 100 000 live and stillbirths. Number of maternal deaths (during pregnancy or within one year following the end of pregnancy) is commonly calculated per 100,000 live births.

Proposed modification: Limit the definition to within 42 days of termination of pregnancy. It should also be recommended that when possible countries extend their systems to include cases up to one year after the end of pregnancy.

In total 16 respondents (80%) agreed, 3 (15%) disagreed and 1 (5%) had no opinion on the modification. Respondents commented that it may be very difficult to find the relationship between the pregnancy and death for the late maternal deaths, i.e. between 43 and 365 days after the end of pregnancy.

3. (R4) Percentage of women who smoke during pregnancy

Current definition: The number of women who smoke during the third trimester of pregnancy expressed as a percentage of all women delivering live or stillborn babies.

Proposed modification: Smoking during pregnancy expressed as 1) The number of women who smoked at any time during pregnancy as a percent of all women delivering live or stillborn babies

64 2) The number of women who smoked in the third trimester as a percent of all women delivering live or stillborn babies

In total 12 respondents (60%) agreed with the first alternative, 2 (10%) with the second alternative, 1 (5%) gave both alternatives and 5 (25%) had no opinion on the modification.

In general, the monitoring of maternal smoking during any time of pregnancy was supported. There was no consensus on whether or not maternal smoking should be measured separately for first trimester or for all three trimesters. It is understood that the rationale, for separately asking the proportion of mothers who smoked during first trimester and who smoked at any time of pregnancy, is to show how many women quit smoking when they notice that they are pregnant. However, the quality of self-reported data was considered to be doubtful. Also the definition of trimesters (in weeks) and calculation of length of pregnancy may vary from country to country, which impedes international comparisons. Some respondents wanted to have even more detailed information on smoking, either by introducing a category of ‘yes, rarely’ or ‘a few daily’ in the currently dichotomised yes/no-variable, or by specifying the amount and the quality of consumed tobacco.

4. (R6) Percentage of all births following fertility treatment

Current definition: The number of women delivering live or stillborn babies after fertility treatment as a percentage of all women delivering live or stillborn babies. Fertility treatments are identified as: − Induction of ovulation only − Artificial insemination only (sperm fresh/frozen) − Artificial insemination any (sperm fresh/frozen) − Implantation of ovum/ova

Proposed modification: − Induction of ovulation only − Artificial insemination − IVF, ICSI, FET, GIFT or other procedures where fertilisation occurs outside the female body

In total 17 respondents (85%) agreed and 3 (15%) had no opinion on the modification, which is harmonised with the definition currently used by ESHRE (European Society of Human Reproduction and Embryology).

5. (R10) Percentage of infants who are breastfeeding at birth

Current definition: The number of newborn babies who are breastfed (baby receives breast milk and is allowed any food or liquid including non-human milk) and who are exclusively breastfed (baby receives breast milk and is allowed to receive drops and syrups) throughout the first 48 hours of age as a proportion of all newborn babies.

Proposed modification: 1) If data are only available at discharge, then can use this information 2) Information should only be presented for term babies (since it is likely to be missing for babies transferred to intensive care…)

65 In total 12 respondents (60%) agreed with the first alternative, 6 (30%) with the second alternative and 2 (10%) gave both alternatives. It seems that information which is available locally at discharge is the most reliable if the exact data on breastfeeding throughout the first 48 hours of age is not available.

6. (R8) Distribution of births by mode of onset of labour

Current definition: The number of deliveries associated with each of the following modes of labour onset, as a proportion of deliveries resulting in a live or stillbirth: − Spontaneous onset − Caesarean section prior to the onset of labour − Labour induction (initiation of uterine contractions) by surgical or pharmacological means prior to the onset of labour. − Proposed clarification: Explain that this definition differs from elective/emergency caesarean sections. Elective caesarean sections that take place after labour has begun should be in the spontaneous onset group.

In total 10 respondents (50%) agreed, 6 (30%) disagreed and 4 (20%) had no opinion on the clarification. The clarification was accepted, but some participants wanted to see a new group of emergency caesarean sections in the current classification or to combine the information on the mode of onset of labour and on mode of delivery in one indicator. For perinatal health information systems which are based on person-level data on deliveries, the latter causes no major problem. For those systems based on aggregated statistics, the suggested re-classification or the combination of two variables may be too cumbersome in practice.

7. (R7) Distribution of timing of 1st antenatal visit

Current indicator: Distribution of timing of first antenatal visit by trimester of pregnancy for all women delivering live or stillborn babies. 1st trimester = <15 weeks 2nd trimester = 15 – 27 weeks 3rd trimester = 28 weeks or more No antenatal care during pregnancy

The participants were asked to verify that the definitions of trimesters are those used in each country. In total 10 respondents (50%) agreed, 7 (35%) disagreed and 3 (15%) had no opinion on the modification. Some countries reported that they do not use trimester in statistics, only weeks. For five countries, the borderline between first and second trimester is 12 weeks instead of 15 weeks of gestation. Some countries indicated that this indicator is problematic, if early visits with private providers are not listed in medical records.

66 DELPHI ON PERINATAL HEALTH INDICATORS with new participants in the EURO-PERISTAT-II project

Round I Results & Round II Questionnaire

ROUND I RESULTS I. Response rate We had an excellent response to the DELPHI round 1 questionnaire: 20 out of 22 potential responses to the Delphi Questionnaire were received. The DELPHI includes contributions from the scientific committee and scientific advisory group in the new EU member states as well as Norway which has also recently joined the EURO-PERISTAT project. Members from Hungary and Latvia submitted joint questionnaires, which are considered as two responses in analyses. All respondents provided complete responses to the Top 10 indicators and Feasibility Ratings of the current PERISTAT indicator set. Nineteen respondents provided comments on the current PERISTAT indicator set. Fourteen respondents provided suggestions for additional indicators, separate from the Top 10 list.

II. TOP 10 List Table 1 summarises responses to the question about the 10 indicators. The table includes all indicators mentioned by at least two participants.

Table 1: Indicators in the top 10 lists with at least 2 votes, by number and percentage of votes Vote Votes PERISTA Indicator s (N) (%) T Indicator Foetal mortality rate * 17 89,5 C1 Neonatal mortality rate * 17 89,5 C2 Maternal mortality rate * 16 84,2 C6 Infant mortality rate * 16 84,2 C3 Birth weight distribution * 16 84,2 C4 Mode of delivery * 15 78,9 C10 Gestational age distribution * 14 73,7 C5 Perinatal mortality rate * 11 57,9 C1/C2 Maternal age * 7 36,8 C8 Multiple birth rate * 6 31,6 C7 Causes of perinatal or neonatal death 5 26,3 F1 Parity * 5 26,3 C9 Congenital malformations 5 26,3 R1 Distribution of timing of 1st antenatal visit 4 21,1 R7 Neonatal morbidity (“severe”, “short-term, long-term”) 4 21,1 F3* Induced abortion rates 3 15,8 Percentage of all births following fertility treatment 3 15,8 R6 Smoking during pregnancy 3 15,8 R4 Distribution of births by mode of onset of labour 2 10,5 R8 Percentage of very preterm births delivered in units without a NICU 2 10,5 R11 Specific Exposures during pregnancy, known or suspected to have an influence on the outcome of pregnancy or the fetus Medication use early in pregnancy (teratogenicity) Folic acid use periconceptionally Alcohol and drug abuse during pregnancy 2 10,5 Hypoxic – ischemic encephalopathy 2 10,5 F3* Distribution of APGAR score at 5 minutes 2 10,5 R2

67 Discussion of Top 10 List y Most indicators mentioned by at least 2 participants as ‘top 10’ indicators are already contained in the PERISTAT list. y The core indicators (labelled with an asterisk in the table) are on this list and rated highly. y The indicator Induced Abortions is not in the PERISTAT list, but received 4 mentions.(See page 5) y Three experts included an indicator of Neonatal Morbidity in their Top 10 list. Proposed definitions include: “Placement on ventilator within first 7 days of life, prolongation of ventilation 3 days or more or neonatal death excluding violence, accidents and severe malformations” and “Neonatal morbidity (long term, short term)” y Two experts proposed an indicator of exposures during pregnancy known to have an influence on outcome.

III. Other Indicators 28 indicators were suggested that were not included in the original set of PERISTAT indicators (by at least one participant in a Top 10 list or when expressly asked for relevant indicators not on the current PERISTAT list in Section 3). These are listed in Table 2.

Table 2: Indicators suggested by participants but not on PERISTAT list Indicator Total Top Section 10 3 NEONATAL/FETAL 1 Abortions 20-24 weeks - induced and spontaneous 1 1 2 Spontaneous abortions 4 1 3 3 pH at birth (or 'asphyxia’ - mix with APGAR?) 3 1 2 4 Infections during neonatal period, neonatal sepsis, nosocomial infections 2 2 5 Intraventricular haemorrhaging and Periventricular leucomalacia 1 1 6 Transfer to ICU 1 1 7 In-hospital mortality 1 1 MATERNAL HEALTH 8 Maternal conditions during pregnancy which may have a specific effect on the pregnancy 2 2 outcome 9 Threatening preterm labour 1 1 10 HIV – remove since this is just a list of what people told us…. 1 1 11 Severe pregnancy and delivery related complication rate 1 1 Definition: labour and delivery related surgery (excluding reparation of I and II degree birth canal lesions), long term (1 year or more) disabilities

POPULATION CHARACTERISTICS/RISK FACTORS 12 Gender ratio 1 1 13 Gravidity (pregnancy parity) 1 1 14 Subpopulation of women with low socio-economical status 1 1 Definition: health care is not covered by insurance or family, Income below existence, homeless, neglect mother or siblings, immigrant status, ethnicity 15 Specific exposures during pregnancy, known or suspected to have an influence on the 2 2 outcome of pregnancy or the fetus : Medication use early in pregnancy (teratogenicity), Folic acid use periconceptionally, Alcohol and drug abuse during pregnancy. HEALTH SYSTEM 16 Attendance at parental classes (indicator of health-care services) 1 1 17 Father present at birth, Presence of partner during labour 2 2 18 Fetal monitoring during delivery 1 1 19 The qualitative content of obstetric care 1 1 20 Preconception care 1 1 21 Content of prenatal care (GBS screening, vaginal pH screening) indicator 1 1 22 Amniocentesis (chromosomal abnormality testing) 1 1 23 Timing of 1st ultrasound scan 1 1 24 Ultrasound examination at 20 weeks of gestation 2 2 25 Newborn screenings: metabolic (phenylketonuria, hypothyreosis, galactosemia), US 2 2

68 kidneys, congenital cataract, hearing screening, developmental dysplasia of the hip (DDH) 26 Home care after delivery, expressed as timing of first visit, total number of vis 1 1 qualifications of visitor. 27 Medical assistance of delivery (hospital, planned home medically assisted, planned 1 1 without medical assistance, accidental out of hospital) 28 Use of anaesthesia 1 1

IV. Definitions and feasibility of PERISTAT core and recommended indicators Participants were asked to provide comments on definitions and to give a feasibility rating for each PERISTAT indicator using its current definition (3 = feasible with no modifications to the existing data systems, 2 = feasible with minor modifications, 1 = feasible with major modifications, 0 = not feasible). Table 3 summarizes the responses.

Table 3: Feasibility Rating of PERISTAT Core and Recommended Indicators Average % feasibility % missing or PERISTAT Core and Recommended Indicators rating <2 unknown C1 Fetal mortality rate 2,55 10 0 C2 Neonatal mortality rate 2,60 10 0 C3 Infant mortality rate 2,50 10 0 C4 Birthweight distribution 2,75 10 0 C5 Gestional age distribution 2,60 10 0 C6 Maternal mortality ratio 1,86 25 30 C7 Multiple birth rate by number of fetuses 2,68 10 5 C8 Distribution of maternal age 2,53 10 15 C9 Distribution of parity 2,60 10 15 C1 Distribution of births by mode of delivery 0 2,60 15 0 R1 Prevalence of selected congenital anomalies 2,10 40 0 R2 Distribution of APGAR score at 5 minutes 2,50 15 0 R3 Maternal mortality by cause of death 1,74 40 5 R4 Percentage of women who smoke during pregnancy 1,67 35 10 R5 Distribution of mother's education 2,44 15 10 R6 Percentage of all births following fertility treatment 1,15 75 0 R7 Distribution of timing of 1st antenatal visit 1,85 35 0 R8 Distribution of births by mode of onset of labour 2,40 25 0 R9 Distribution of place of birth 2,50 20 0 R1 Percentage of infants breast-feeding at birth 0 2,20 40 5 R1 % of very preterm births delivered in units without a NICU 1 2,45 15 0

Discussion of Feasibility Rating y With the exception of the maternal mortality ratio, all core indicators received an average rating of 2 or more, with at least 75% of respondents rating feasibility at 2 or more. y There were 7 recommended indicators with an average rating of less than 2 or judged feasible only after major modifications or not at all 2 by 25% or more respondents. Comments related to these indicators are presented in Table 4.

Table 4: Comments Related to Indicators Receiving a Poor Feasibility Rating Indicator Principal comments Maternal mortality No information on deaths up to one year Maternal mortality by cause of death Quality of ascertainment Not available by some of the subgroups Percentage of women who smoke during pregnancy Information not available in the 3rd trimester – in first trimester or on smoking habits generally Underreporting frequent

69 Percentage of all births following fertility treatment Questions about definitions Underreporting frequent Distribution of timing of 1st antenatal visit Definitions of trimesters (<12 weeks not 15) Early visits not always noted in medical records Prevalence of selected congenital anomalies Induced abortions for congenital anomalies not available Distribution of births by mode of onset of labour Clarification of PERISTAT definition in relation to ‘programmed vs. emergency’ c-sections Percentage of infants breast-feeding at birth Data not available at 48 hours, but at discharge Should this indicator be only for term babies?

70 ROUND II QUESTIONNAIRE

This questionnaire has 2 sections: y Candidate indicators for addition to the PERISTAT list or for further work y Modifications to indicator definitions.

I. Indicators that could be added to the indicator list or for further consideration

1. Induced abortion: Several participants mentioned induced abortion on their top 10 lists. This was also highly rated in the DELPHI in PERISTAT I. The REPROSTAT project has a recommended indicator on induced abortion (definition in 2 parts: number of induced abortions per 1000 women aged 15-49 and (2) the number of induced abortions per 1000 live births). However, it may be useful to include an indicator related to late induced abortions for the description of the pregnancy outcome.

a. What is your opinion about adding induced abortion to the PERISTAT list? ˆ Yes ˆ No How it should be labelled? Late termination of pregnancy (20+ weeks) Termination for medical reason (any timing) Other; comment:

b. Do you agree with the following description? ˆ Yes ˆ No

Number of induced abortions by the following gestational age groups: <20 weeks 20-21 weeks 22-23 weeks 24-27 weeks 28 weeks and later

If no, please propose modifications to this description:

c. Is this indicator feasible in your country, given the definition above?

ˆ yes, with minor modifications ˆ yes, with major modifications ˆ no

Comments:

2. Neonatal morbidity: Several participants suggest including an indicator of neonatal morbidity. We already have two indicators on morbidity associated with perinatal events – HIE (F3) and cerebral palsy (F4). However, there is no indicator on short-term health outcomes. This indicator had a high rating in the previous DELPHI as well. We propose that the working group on neonatal morbidity develop an indicator of severe morbidity

a. Should we develop an indicator of neonatal morbidity?

ˆ Yes, I agree ˆ No, not a priority If you answered yes to the above question, please provide your opinion about the most appropriate indicator. Your comments will be provided to the working group on neonatal morbidity for their future work.

71 3. Content of perinatal care: Many participants propose indicators that address the content of perinatal care. However, there is no clear consensus on an appropriate indicator. In the last DELPHI, we also found it difficult to agree on only one indicator. We propose that the working group on positive birth outcomes looks at whether it is possible, at this time, to find an indicator that would be useful in all European contexts. According to the aim of this group, this indicator would focus on, support or services for low risk women.

a. Should we ask the working group on positive birth outcomes to assess the possibility of developing an indicator on the content of perinatal care?

ˆ Yes, I agree ˆ No, not a priority

If you answered yes to the above question, please provide your opinion about the most appropriate indicator. Your comments will be provided to the working group on positive birth outcomes for their future work.

4. Improving use of existing indicators: The following issues should be addressed in the WP7 on harmonizing methods for compiling indicators: y Finding a common cause of classification for fetal and neonatal deaths from existing European lists y Obtaining more information on gestational age determination in each European country (source of determination, choice of the best estimate ….)

Do you agree with the priority on cause of death classifications? ˆ Yes ˆ No

Do you agree with the priority on gestational age? ˆ Yes ˆ No

If you have additional suggestions for priority areas of work, please note them here:

5. Policy indicators: In PERISTAT I, two policy indicators (collected at the national level) were proposed but were never adopted. These were on maternity leave provisions and neonatal screening policies. For maternity leave, a website within the EU (DG-Employment) already lists policies related to maternity (and paternity) leave. On the other hand, we could develop an indicator on neonatal screening. To do so we would need to assess existing policies.

Are you in favour of adding a policy indicator on neonatal screening?

ˆ Yes, I agree ˆ No, not a priority

In your country is there a national policy governing screening of the newborn at birth? ˆ Yes ˆ No

72 If yes, what screening tests are required at birth in your country?

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II. Proposed modifications to definitions of indicators The following issues were raised in relation to the definitions of the indicators:

Indicator Current Definition Proposed modification Ag Indicators The 22 and 23 week groups should be presented ˆ including separately since many countries only begin to gestational age collect data at 24 weeks of gestation Co C1-C5

Definition: The number of maternal deaths (the death Proposed modification: limit the definition to ˆ C6- Maternal of a woman while pregnant or within one year of the within 42 days of termination of pregnancy. mortality ratio termination of pregnancy, irrespective of the duration Recommend that when possible countries extend Co and site of the pregnancy, for any cause related to or their systems to include cases up to one year after R3- Maternal aggravated by the pregnancy or its management, but the end of pregnancy. mortality by cause not from accidental or incidental causes) per 100 000 of death live and stillbirths.

Number of maternal deaths (during pregnancy or within one year following the end of pregnancy) per 100,000 live births

R4- Percentage of The number of women who smoke during the third Proposed modification : Smoking during ˆ women who smoke trimester of pregnancy expressed as a percentage of all pregnancy expressed as during pregnancy women delivering live or stillborn babies. 1Æ the number of women who smoked at any Co time during pregnancy as a percent of all women delivering live or stillborn babies 2Æ the number of women who smoked in the third trimester as a percent of all women delivering live or stillborn babies R6- Percentage of The number of women delivering live or stillborn Harmonise definition with ESHRE (European ˆ all births following babies after fertility treatment as a percentage of all Society of Human Reproduction and fertility treatment women delivering live or stillborn babies. Fertility Embryology). Co treatments are identified as: 1 • Induction of ovulation only Other suggestion • Artificial insemination only (sperm 5. INDUCTION OF OVULATION ONLY fresh/frozen) 5.1. Artificial insemination • Artificial insemination any (sperm 5.2. IVF, ICSI, FET, GIFT or other fresh/frozen) procedures where fertilisation • Implantation of ovum/ova occurs outside the female body 5.3.

R10- Percentage of Definition: The number of newborn babies who are 1. if data are only available at discharge, then ˆ infants who are breastfed (baby receives breast milk and is allowed any can use this information breastfeeding at food or liquid including non-human milk) and who are 2. Information should only be presented for term Co birth exclusively breastfed (baby receives breast milk and is babies (since it is likely to be missing for allowed to receive drops and syrups) throughout the babies transferred to intensive care…) first 48 hours of age as a proportion of all newborn babies.

1 The following countries are currently participating in the data collection: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, the Netherlands, Norway, Poland, Portugal, Russian Federation, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Ukraine, United Kingdom

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R8- Distribution of The number of deliveries associated with each of the - Explain that this definition differs from ˆ births by mode of following modes of labour onset, as a proportion of elective/emergency caesarean sections. onset of labor deliveries resulting in a live or stillbirth: Elective caesarean sections that take place Co * Spontaneous onset after labour has begun should be in the * Caesarean section prior to the onset of labour spontaneous onset group. * Labour induction (initiation of uterine contractions) by surgical or pharmacological means prior to the onset of labour. R7- Distribution of Distribution of timing of first antenatal visit by - Verify that the definitions of trimesters are Ar timing of 1st trimester of pregnancy for all women delivering live or those used in each country sa antenatal visit stillborn babies. - Note that there is a difficulty with this sy • 1st trimester = <15 weeks indicator in countries where early visits with Co • 2nd trimester = 15 – 27 weeks private providers are not listed in medical • 3rd trimester = 28 weeks or more records. • no antenatal care during pregnancy

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V. Summary of results from the DELPHI with the new European member states

New Indicators

Æ Induced abortions An indicator of induced abortion should be added to the PERISTAT list, even though this indicator may not be feasible everywhere at this time. This indicator should focus on late induced abortions; however, the exact definition needs to be developed.

Æ Severe neonatal morbidity (to be developed) The working group on neonatal morbidity should include the development of an indicator of severe morbidity among its objectives. The list of suggested indicators should be transmitted to this working group.

Æ Content of perinatal care (to be developed) The working group on positive birth outcomes should investigate whether it is possible to find an indicator on the content of perinatal care that would be useful in all European contexts. According to the aim of this group, this indicator would focus on support or services for low-risk women. The list of suggested indicators should be transmitted to this working group.

Æ A policy indicator on neonatal screening. This indicator would list which screening tests are part of the national policy on newborn screening at birth.

Improving the use of existing indicators

Two priorities were underlined

Æ Finding a common cause of death classification for EURO-PERISTAT Æ Assessing how gestational age is determined in European countries

Changes to definitions of existing indicators

For three indicators, there was a clear consensus about changing the definition or subgroup included in the definition - Gestational age distribution and other indicators: When EURO-PERISTAT indicators are presented, it should be possible to separate out births at 22 and 23 weeks. - Maternal mortality: Countries should be advised to monitor deaths occurring within the range of one year after the end of pregnancy. International comparisons should only include maternal deaths occurring during pregnancy and within 42 days after its termination. - Percentage of all births following fertility: definition should be changed to reflect ESHRE guidelines/definition.

For the other indicators, the agreement was less clear. However, these comments should be taken into consideration for the data collection exercise in 2006 in order to help improve the quality of the indicators and to assess what solutions can be proposed in cases where definitions differ.

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DELPHI QUESTIONNAIRE ON PERINATAL HEALTH INDICATORS FOR THE EURO-PERISTAT PROJECT

Objectives: A consensus on perinatal health indicators to be included in a European indicator set

This indicator set is intended for health professionals, policy makers, researchers and health service users who wish to compare perinatal health indicators over time and between countries. Using this European indicator set, the EURO-PERISTAT II project aims to facilitate the surveillance and comparison of perinatal health in the EU by harmonizing indicator definitions and encouraging the collection of comparable data in all member states. Our priorities are to:

1. Assess maternal and infant mortality and morbidity associated with events in the perinatal period.

2. Describe the evolution of risk factors for perinatal health outcomes in the population of childbearing women, including demographics, socio-economic and behavioural factors.

3. Monitor the use and consequences of medical technology in the care of women and infants during pregnancy, delivery and postpartum period.

4. Provide information on the perinatal health care system

Instructions:

This questionnaire has 3 sections.

First, we would like to know which ten indicators of perinatal health you feel are essential parts of a European health information system.

Attached is a list of indicators, with their definitions, taken from our review of existing national and international recommendations on perinatal health indicators. You may use this list to guide your choices, but please feel free to include indicators that are not in this list.

Second, we would like your comments on the indicators that are currently in the PERISTAT indicator set. We request your comments on the definitions of these indicators and the sub-groups selected for their presentation.

Third, we would like you to tell us if there are specific indicator(s) which are relevant for monitoring perinatal health in your country which were not included in the current list of PERISTAT indicators.

6. DEADLINE: PLEASE RETURN THE QUESTIONNAIRE BY THE FRIDAY 14 OCTOBER 2005, EITHER BY EMAIL TO [email protected] OR BY POST TO JOANNA MCCORMACK, STAKES, P.O. BOX 220 (LINTULAHDENKUJA 4), 00531 HELSINKI, FINLAND, FAX TO +358 9 3967 2497. 7. NEXT STEP: A SECOND QUESTIONNAIRE WILL BE SENT TO YOU IN MID-NOVEMBER. YOU WILL BE ASKED TO GIVE YOUR OPINION ON THE RESULTS OF THE FIRST QUESTIONNAIRE. 8. IF YOU HAVE ANY QUESTIONS, PLEASE CONTACT MIKA GISSLER /JOANNA MCCORMACK- [email protected] OR [email protected].

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Section 1: Please indicate the ten indicators of perinatal health that you feel are essential parts of a European health information system. (you may use as a guide the attached document from our review of the literature on indicators).

1

2

3

4

5

6

7

8

9

10

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Section 2: Please comment on the indicators in the PERISTAT indicator set. For each core and recommended indicator in the table below, please

1. Comment on the definition and sub-categories.

2. Give a feasibility rating for the indicator in your country. In other words, do you think it is possible to construct this indicator using its definition with the data currently collected on perinatal health in your country? Ratings: 3 = feasible with no modifications to existing data systems 2 = feasible with minor modifications 1= feasible with major modifications 0 = not feasible 9= I don’t know

PERISTAT LIST OF CORE and RECOMMENDED INDICATORS Definition of indicator and specifications of subcategories for Feasibility Comments on Definition and Category Indicator construction of indicator Rating subcategories (C)Core Indicators (R)Recommended Definition Subcategories 0 1 2 3 Comments, if any Indicators (F)Indicators for further development The number of fetal deaths at or after Neonatal 22 completed weeks of gestation in a C1-Fetal mortality rate health given year per 1000 live and stillbirths in the same year. Computed by: gestational age,

birth weight and plurality

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PERISTAT LIST OF CORE and RECOMMENDED INDICATORS Definition of indicator and specifications of subcategories for Feasibility Comments on Definition and Category Indicator construction of indicator Rating subcategories (C)Core Indicators (R)Recommended Definition Subcategories 0 1 2 3 Comments, if any Indicators (F)Indicators for further development The number of deaths in the neonatal period (up to 28 completed days after birth) after live birth at or after 22 complete weeks of gestation in a given Neonatal year, expressed per 1000 live births in the C2-Neonatal mortality rate health same year. This rate is sub-divided by timing of death into early neonatal deaths (at 0-6 days after live birth) and late neonatal deaths (at 7-27 days after live births). Computed by: gestational age,

birth weight and plurality.

The number of deaths (day 0-364) after live birth at or after 22 completed Neonatal C3- Infant mortality rate health weeks gestation in a given year expressed per 1000 live births in the same year. Computed by: gestational age, birth weight and

plurality

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PERISTAT LIST OF CORE and RECOMMENDED INDICATORS Definition of indicator and specifications of subcategories for Feasibility Comments on Definition and Category Indicator construction of indicator Rating subcategories (C)Core Indicators (R)Recommended Definition Subcategories 0 1 2 3 Comments, if any Indicators (F)Indicators for further development Number of births within each 500g Neonatal weight interval expressed as a C4- Birthweight distribution health proportion of all registered live and stillbirths. Computed by: vital status at birth, gestational age, and plurality.

Number of live births and fetal deaths Neonatal C5- Gestional age at each completed week of gestation health distribution (starting from 22 weeks) expressed as a proportion of all live and still births. This distribution is presented as follows: 22-36 weeks of gestation (preterm births) 37-41 weeks (term births) 41+ weeks (post-term) Preterm births can be subdivided in to 22-27 weeks (extremely preterm) 28-32 weeks (very preterm) 32-36 weeks (moderate preterm) Computed by: vital status at birth and plurality

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PERISTAT LIST OF CORE and RECOMMENDED INDICATORS Definition of indicator and specifications of subcategories for Feasibility Comments on Definition and Category Indicator construction of indicator Rating subcategories (C)Core Indicators (R)Recommended Definition Subcategories 0 1 2 3 Comments, if any Indicators (F)Indicators for further development

Population The number of women with a multiple characteristic C7-Multiple birth rate by gestation pregnancy at delivery s or risk number of fetuses expressed as a proportion of all women factors delivering live or stillborn babies.

Population characteristic C8-Distribution of maternal Distribution of age in years at delivery s or risk age for women delivering a live or stillbirth. factors Recommended presentation as follows: 10-14,

15-19, 20-24, 25-29, 30-34, 35-39, 40-44, 45+.

Population Distribution of parity (number of characteristic C9- Distribution of parity s or risk deliveries) of women delivering a live factors or stillbirth.

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PERISTAT LIST OF CORE and RECOMMENDED INDICATORS Definition of indicator and specifications of subcategories Feasibility Comments on Definition and Category Indicator for construction of indicator Rating subcategories (C)Core Indicators (R)Recommended Definition Subcategories 0 1 2 3 Comments, if any Indicators (F)Indicators for further development For a population of women giving Health care C10-Distribution of births birth in a given year: the number of services by mode of delivery deliveries associated with each of the following modes: --Spontaneous vaginal --Instrument assisted vaginal (subdivided into

forceps and ventouse ) --Caesarean undertaken before onset of labour --Caesarean undertaken during labour each expressed as a proportion of total annual

births. Computed by: the presentation of fetus, parity,

previous caesarean section, plurality

The number of live births, fetal deaths and induced abortions with neural tube R1-Prevalence of selected defects or Down’s syndrome as a Neonatal congenital anomalies health Down's syndrome Neural proportion of all live births, fetal tube defects deaths and induced abortions

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PERISTAT LIST OF CORE and RECOMMENDED INDICATORS Definition of indicator and specifications of subcategories Feasibility Comments on Definition and Category Indicator for construction of indicator Rating subcategories (C)Core Indicators (R)Recommended Definition Subcategories 0 1 2 3 Comments, if any Indicators (F)Indicators for further development Neonatal R2-Distribution of APGAR Distribution of APGAR score at 5 health score at 5 minutes minutes (0-10)

Number of maternal deaths (during pregnancy or within one year Maternal R3-Maternal mortality by

Health cause of death following the end of pregnancy) per 100,000 live births subdivided into the following causes: * Thromboembolism * Hypertension * Haemorrhage * Amniotic fluid embolism * Sepsis * Early pregnancy deaths * Anaesthesia * Genital tract trauma and other direct

causes * Indirect causes (as defined in ICD-10,

WHO) * Coincidental (fortuitous) and late deaths (between 43-365 days following the end of pregnancy)

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PERISTAT LIST OF CORE and RECOMMENDED INDICATORS Definition of indicator and specifications of subcategories for Feasibility Comments on Definition and Category Indicator construction of indicator Rating subcategories (C)Core Indicators (R)Recommended Definition Subcategories 0 1 2 3 Comments, if any Indicators (F)Indicators for further development Population The number of women who smoke during R4- Percentage of women characteristic the third trimester of pregnancy expressed who smoke during s or risk pregnancy as a percentage of all women delivering factors live or stillborn babies.

The distribution of education level of women delivering live or stillborn babies, Population expressed as highest completed level of characteristic R5- Distribution of mother's education, or number of completed years of s or risk education education (as recommended by the Health factors Monitoring Programme guidelines for monitoring socio-economic inequalities in health, final report, Feb 2001).

The number of women delivering live or stillborn babies after fertility treatment as a Health care R6- Percentage of all births percentage of all women delivering live or services following fertility treatment stillborn babies. Fertility treatments are identified as: * Induction of ovulation only * Artificial insemination only (sperm

fresh/frozen) * Artificial insemination any (sperm

fresh/frozen) * Implantation of ovum/ova

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PERISTAT LIST OF CORE and RECOMMENDED INDICATORS Definition of indicator and specifications of subcategories for Feasibility Comments on Definition and Category Indicator construction of indicator Rating subcategories (C)Core Indicators (R)Recommended Definition Subcategories 0 1 2 3 Comments, if any Indicators (F)Indicators for further development Distribution of timing of first antenatal Health care R7- Distribution of timing of visit by trimester of pregnancy for all services 1st antenatal visit women delivering live or stillborn babies.

The number of deliveries associated Health care R8- Distribution of births by with each of the following modes of services mode of onset of labour labour onset, as a proportion of deliveries resulting in a live or stillbirth: * Spontaneous onset * Caesarean section prior to the onset of

labour * Labour induction (initiation of uterine contractions) by surgical or

pharmacological means prior to the onset of labour. Computed by: gestational age and plurality

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PERISTAT LIST OF CORE and RECOMMENDED INDICATORS Definition of indicator and specifications of subcategories for Feasibility Comments on Definition and Category Indicator construction of indicator Rating subcategories (C)Core Indicators (R)Recommended Definition Subcategories 0 1 2 3 Comments, if any Indicators (F)Indicators for further development

Number of births occurring at home or in maternity units defined by the total number of births in the same year, with Health care R9- Distribution of place of services birth the following groups: home, < 300, 300- 499, 500-999, 1000-1499, 1500-1999, 2000-3999, 4000+. The number of units in each category should also be provided.

The number of newborn babies who are breastfed (baby receives breast milk and is allowed any food or liquid including non-human milk) and who are exclusively breastfed (baby receives breast milk and R10- Percentage of infants is allowed to receive drops and syrups)

breast-feeding at birth throughout the first 48 hours of age as a proportion of all newborn babies. (Definitions from WHO Indicators for Assessing Breastfeeding Practices. Report from meeting 11-12 June 1991. Geneva, 1991.)

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PERISTAT LIST OF CORE and RECOMMENDED INDICATORS Definition of indicator and specifications of subcategories for Feasibility Comments on Definition and Category Indicator construction of indicator Rating subcategories (C)Core Indicators (R)Recommended Definition Subcategories 0 1 2 3 Comments, if any Indicators (F)Indicators for further development The percentage of preterm live and stillbirths less than 32 weeks of gestation that are born in a maternity unit without R11- Percentage of very Health care an on-site neonatal intensive care unit. preterm births delivered in services units without a NICU The percentage of very preterm births should be presented by level of maternity unit using local official definitions or unofficial definitions.

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Indicators for further development These indicators do not have operational definitions and their development is part of our work in the EURO-PERISTAT project. However, if you have comments about these indicators, please provide below.

F1-Causes of perinatal death F2-Prevalence of cerebral palsy F3-Prevalence of hypoxic-ischemic encephalopathy F4-Prevalence of severe maternal morbidity F5-Prevalence of trauma to the perineum F6- Prevalence of faecal incontinence F7-Postpartum depression F8-Distribution of mother's country of origin F9-Indicator of support to women F10- Indicator of maternal satisfaction F11-Births attended by midwives F12-Births without medical intervention

Comments about indicators for future development

Section 3: If you feel there are specific indicator(s) which are relevant for monitoring perinatal health in your country that is not on the currently list of PERISTAT indicators, please indicate below and provide your reasons.

Additional Comments:

Thank you for taking the time to fill in the questionnaire. Name of respondent :

Institution, Country

Date

1 D ECEMB ER 2005 EURO-PERISTAT II PROJECT UPDATE

INSIDE THIS ISSUE:

Porto Congress 1 Congress on improving data and its use in Health & Health Policy 1 decision-making to be held in June in Porto New Member States 2

February 15, 2006 using the Measuring Inequalit y 2 form on page 6. Normal Birth 2 The congress will be statistics Neonatal Morbidity 3 hosted by Henrique Bar- FOR ros and the University of P art ner Spot light 3 Porto Medical School, Department of Hygiene and Maternal Morbidity 3

BETTER Epidemiology. A website to Cerebral Palsy 4 FOR support registration and health other information is cur- EPEN Meets in Siena 4 pregnant women and their babies rently being developed. Information about registra- Porto Flyer 5 Springtime in Porto will of European legislation on tion will be sent out in the Abstract Submission 6 be the setting for the upcom- privacy. new year. ing congress Better Statistics Pioneering efforts to If you have any col- for Better Health. Abstracts develop perinatal indicators leagues who may be inter- The EURO-PERISTAT that capture morbidity, posi- for the Better Health for Better ested in attending the con- Statistics congress are due project will welcome a tive pregnancy outcomes, gress, please distribute this February 15, 2006. broad range of perinatal and socio-economic inequal- information or forward their health professionals on June ity will also be profiled. Submit yours using the form on names to M eg Zimbeck at page 6. Travel funds are avail- 2 & 3 to explore how data The congress will also [email protected]. able for selected presenters. can be improved and used to focus on translating better Participation will be affect policy change. The statistics into better health. funded for all members of congress will include both A session exploring trends the Scientific Committee. oral and poster sessions. in health reporting will also Some additional funding Sessions will highlight present data collected from will be available for present- innovative methods for stakeholders regarding poli- ers, data providers, and other improving data collection cymaking in perinatal health experts. Inquiries about and analysis, including chal- in EU member states. funding should be directed lenges relating to the impli- Abstracts are solicited to M eg Zimbeck. cations and implementation and may be submitted by Porto, P ort ugal Translating health information into better health outcomes

What are policymakers doing with understand variation between member ganization of perinatal policymaking all this data? Which institutions and states in the way that policymaking is institutions in EU members states and people have the power to impact health organized and the way data is used in will use this information to establish outcomes? decision-making. mechanisms for disseminating health M eg Zimbeck of INSERM has been This insight will support the devel- data and periodic reports. asking these and other fundamental opment of a more structured survey tool Special thanks to Henrique Barros, questions in semi-structured telephone that will be used to gather the perspec- Béatrice Blondel, Gérard Breart, interviews with partners in Austria, tive of stakeholders from each EU Simone Buitendijk, Nicolas Drey, M ika Finland, France, Germany, the Nether- member state regarding their needs with Gissler, Wolfgang Kuenzel, Nicolas lands, Portugal and the United King- respect to perinatal health information. Lack, Jan Nijhuis, and Christian Vutuc dom. In doing so, she hopes to better Zimbeck is also mapping the or- for participating in these interviews.

2

VOLUME 1, ISSUE 1

New member states meet in Bratislava, assess indicator set The EURO-PERISTAT systems, and explain the committees were expanded DELPHI consensus method- this year to include partners ology to be used for adapt- from all ten new EU mem- ing the indicator list to the ber states. The project now health context of new states. includes an official partner The Institute of Health (Scientific Committee) as Information and Statistics well as other experts (UZIS) served as excellent New project members meet in Bratislava A. Gaizauskiene presents abou t Lithuania (Scientific Advisory Group) hosts in Bratislava, with from each EU member state. special thanks to Peter Hlava one survey in November. For more information about The Steering Committee and Renata Lenharcikova. Participants are complet- the first round results, or met with these new partners Project partner STAKES regarding the round two in Bratislava in September ing a second round survey continues to coordinate that is due to Joanna M cCor- questionnaire, email: to present the project, assess [email protected] DELPHI process and com- mack by December 21. new member data collection pleted analysis of the round Group working to develop indicators of inequality & exclusion

The data collection performed in the review and planning a first working • Frantisek Bauer, Slovak Republic first PERISTAT project was not able to group meeting in conjunction with the • Francisco Bolumar, Spain take into account inequalities or adverse Better Statistics for Better Health con- • Alison M acfarlane, UK health outcomes related to poor social gress in Porto next June. • Rhonda Small, Australia circumstances. This reflects a double EURO-PERISTAT partners are problem: very few indicators of socio- invited to indicate their interest to the • Anita Gagnon, Canada economic status are collected at deliv- ULB team if they are interested in join- • Babill Stray-Pedersen, Norway ery in European countries, and data are ing this working group. Funding is • Johan M ackenbach, Netherlands not consistent across countries. available for travel to group meetings. If you are interested but your name In response to this growing concern, Colleagues and external experts Sophie Alexander of the Université is not on this list, please contact Sophie who previously have expressed interest Alexander at: [email protected], or Libre de Bruxelles (ULB) is leading a in joining the working group include: working group to develop indicators of by telephone at: + 32.2.555.4063 • Christian Vutuc, Austria inequalities in the outcome of preg- You are also invited to recommend nancy and social exclusion. • Mika Gissler, Finland other colleagues or share the names of Alexander and her colleague Wei- • M eg Zimbeck, France individuals conducting innovative re- hong Zhang are completing a literature • Henrique Barros, Portugal search in this area.

Understanding normal birth: a working group & upcoming conference

The fact that the majority of women • Béatrice Blondel, France ing group, please contact Alison do not experience major life-threatening • Istvan Berbik, Hungary M acfarlane at: [email protected] complications in pregnancy and deliv- • Karin van der Pal, Netherlands or by telephone at: + 32 2.555.4063 ery has prompted a growing desire to • Simone Buitendijk, Netherlands You are also invited to recommend measure and monitor normal birth and other colleagues or share the names of Frantisek Bauer, Slovak Republic positive outcomes. • individuals conducting innovative re- Alison M acfarlane of City Univer- • Jan Nijhuis, Netherlands search in this area. sity in London is leading an effort to • Lee Tammemae, Estonia The upcoming working group meet- develop indicators of positive preg- • Luule Sakkeus, Estonia ing is being held in conjunction with the nancy outcome for EURO-PERISTAT. • Ivan Verdenik, Slovenia third international research conference With her colleague Nicolas Drey, on Normal Labour & Birth. Macfarlane is organizing a working • Maggie Redshaw, UK The Normal Labour & Birth confer- group that will meet on June 6 in • M iranda Dodwell, UK Grange Over Sands, England. ence will be held in Grange Over Sands, • Marianne Mead, EU Midwives Assn. England from June 7-9, 2006. For more Colleagues who previously have information contact Alison M acfarlane. expressed interest in joining the work- If you would like to add your name ing group includ e: or recommend a colleague to this work-

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PROJECT UPDATE

Neonatal morbidity & long-term consequences of perinatal events

The PERISTAT feasibility study with regional neonatal intensive care • Gérard Breart, France showed that routine data about neonatal networks to identify appropriate defini- • Nicolas Lack, Germany morbidity and the longer-term morbid- tions of and data sources for an indica- • Wolfgang Kuenzel, Germany ity associated with perinatal events are tor of hypoxic ischaemic encephalopa- sparse. thy (HIE) and on assessing existing • Ilze Kreicberga, Latvia Nijole Vezbergiene, Lithuania Christine Cans, of the European follow-up programs for high-risk new- • Network of Cerebral Palsy Registers borns. • Francisco M orcillo, Spain (SCPE) is leading the EURO- Colleagues who previously have If you are interested in this working PERISTAT effort to develop and imple- expressed interest in joining the work- group but your name is not on the list, ment an indicator of cerebral palsy. ing group include: please contact Jennifer Zeitlin at: Jennifer Zeitlin of INSERM U-149 • Christian Vutuc, Austria [email protected] or by tele- and interested partners will collaborate • Paul Defoort, Belgium phone at: + 33 1.42.34.55.79 Partner Spotlight: Globe-trotting Mika Gissler from STAKES

monitor- M ika Gissler is a little worried to receive an email response from M ika ing sys- about the heat during the upcoming within minutes, even when he’s halfway tem will congress in Porto. The Finnish epidemi- around the world. be imple- ologist spends his free time scuba div- Mika’s favorite place for work mented ing in icy waters, so the average June travel is Copenhagen, which has be- after a temperatures of 22° in Portugal are a bit come like a second home. He also long pe- higher than he prefers. makes regular visits to Iceland, the riod of When he’s not in the Faroe Islands, and develop- water, Mika is responsi- Greenland. These ment and ble for health statistics more exotic locations projects. and registers for “I do hope that the can present challenges This will STAKES, Finland’s Na- to productivity, how- require tional Research and De- European health ever. On a recent trip EU level velopment Centre for monitoring system will be to western Greenland, resources for data collection, analysis Health and Welfare. Mika was awoken one and reporting. Hopefully special interest With additional re- implemented after a long very light evening groups will support this kind of centre when all 6,000 dogs of to ensure that perinatal health, reproduc- sponsibility for interna- period of development tional cooperation, M ika Ilullissat began bark- tive health, and child/adolescent health spends almost as much and projects.” ing in unison at 2 am! are included in the system.” time traveling as he does For Mika, the de- For EURO-PERISTAT II, Mika back home at STAKES. sired outcome of all leads a team from STAKES in an effort This doesn’t keep him from staying this travel is a compre- to integrate the new EU member states in touch, however. Colleague Joanna hensive European monitoring system. and ensure that the perinatal informa- McCormack says that she always seems “I do hope that the European health tion system reflects their needs. Experts to consider new indicators of maternal morbidity

The absence of data on maternal sources, and collect data for indicators • Ray Galea, M alta health during pregnancy, childbirth and of maternal morbidity. • Bogdan Chazan, Poland the postpartum period is a key gap in Colleagues who have previously • Katarzyna Szamotulska, Poland the current perinatal health information expressed interest in joining this work- • Ziva Novak-Antolic, Slovenia system. There are currently no widely ing group include: accepted definitions of or inclusion • Gunilla Lindmark, Sweden • Christian Vutuc, Austria criteria for the conditions that constitute If you are interested in joining this severe maternal morbidity in Europe. • Petr Velebil, Czech Republic working group but your name is not on M arie Hélène Bouvier Colle of • Lee Tammamae, Estonia the list, please contact M arie Hélène INSERM is leading the II effort to ad- • Christine Cans, France Bouvier Colle at +33 1 42 34 55 72 or dress this growing concern. A working • M eg Zimbeck, France by email at [email protected]. group is being formed that will seek to Wolfgang Kuenzel, Germany harmonize definitions, validate data •

4

EURO-PERISTAT II Cerebral Palsy registers spread across Europe is coordinated by : Cerebral Palsy (CP) is 10,000 CP cases born be- hagen in June 2005. one of the most common tween 1976 and 1996. SCPE The SCPE network, disabling conditions in has also developed guide- which comprises 14 regis- childhood, occurring in 1.5 – lines for submitting cases to ters in predominantly north- 2 births per 1,000. The first the common database, a ern countries, will also work PERISTAT project identi- standardized data collection toward implementing new fied CP as an indicator re- form, and a SCPE Reference registers in southern and quiring future development and Training M anual (CD- eastern European countries. because of differences that Rom) which contains video In 2006, visits are planned to exist in case definition and pieces of children with CP, new centres in Latvia, Institut national de la santé et inclusion criteria used by and is available now in 6 Lithuania, Portugal, Slove- de la recherche médicale, U-149 surveys, registers, and clas- different languages. nia, and Spain. sification systems. 123 boulevard Port Royal SCPE, led by project SCPE has also com- 75014 Paris, France To further develop this partner Christine Cans of pleted an analysis of the Fax: +33 1 43 26 89 79 indicator, the EURO- Grenoble, France, has re- health outcomes, including Jennifer Zeitlin, Scientific Coordinator PERISTAT II project has cently completed a review CP, of multiple pregnancies Tel: +33 1 42 34 55 79 partnered with the European comparing the perinatal using different data sources. Email: [email protected] Network of Cerebral Palsy indicators recommended by The results will be presented Registers (SCPE), which has PERISTAT with those col- Meg Zimbeck, Project Coordinator at the Porto congress in June Tel: +33 1 42 34 55 74 been conducting standardi- lected by population-based 2006. A second plenary Email: [email protected] sation and harmonisation registers such as EUROCAT meeting for the SCPE net-

work over the past six years and SCPE. This review, work will follow in Lithua- Gérard Breart, Project Leader with funding from the Euro- which analysed differences Tel: +33 1 42 34 55 70 nia in October 2006. Email: [email protected] pean Commission. This between the proposed peri- work has enabled SCPE to natal items as well as the For more information pool together CP cases from feasibility of collecting new visit the SCPE website at different registers in a com- items, was presented at a http://www-rheop.ujf- mon database of more than plenary meeting in Copen- grenoble.fr/scpe2/site_scpe. EURO-PERISTAT supports EPEN in Siena

EURO-PERISTAT II Small from Australia organ- European research on fol- actively participated in the ized a session examining low-up of high-risk births. We’re on the web! European Perinatal Epidemi- reproductive health and the A panel of researchers dis- ology Network (EPEN) care of migrant women. cussed important health http://europeristat.aphp.fr meeting in Siena, Italy on They also proposed an outcomes, including quality August 31, 2005. international collaboration to of life measures, populations Project partner Alison compliment the work of that should be followed up, Macfarlane from City Uni- EURO-PERISTAT in inves- appropriate ages for follow- versity in London, England tigating the extent to which up, specification of common organized a session investi- comparable, population- data items for research and gating socio-economic dif- based reproductive health for recording within routine ferences in perinatal health and health care data on new- clinical follow-up programs, in Europe, highlighting the comers, including migrants and strategies for minimiz- various occupational and and refugees, are available. ing loss to follow-up. Panel- educational measures that The session gave rise to ists included E. Draper are recorded in national data several ideas for collabora- (UK), M. de Klein (the collection systems, as well tive research, including a Netherlands), B. Larroque as indices of area depriva- project on Somali woman (France), N. Marlow (UK), tion developed in European that is currently underway. and project partners M. Cut- countries. Along with For more information or to tini (Italy) and J. Zeitlin M acfarlane, presentations get involved with the Repro- (France). came from Eric Harrison ductive Outcomes And Mi- (UK), Helen Dolk (UK) and grants (ROAM ) project, project partners Katarzyna contact Anita Gagnon at EURO-PERISTAT is a project of the Szamotulska (Poland), and [email protected]. European Commission Public Health Program Jennifer Zeitlin (France). In addition, several pro- Canadian researcher ject partners participated in a Anita Gagnon and Rhonda round-table discussion of

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Statistics BETTER FOR JUNE 2-3 2006 FOR health pregnant women and their babies Join us in Porto!

How is data used to make decisions that impact the lives of pregnant women A CONGRESS FOR and their babies? How can the quality of this data be improved? PERINATAL HEALTH Join EURO-PERISTAT in Porto this spring as we bring together perinatal PROFESSIONALS AND health professionals and policymakers from every EU member state to POLICYMAKERS examine these important questions.

The Better Statistics for Better Health congress will include sessions on: • Innovative methods for improving the quality of data on perinatal health: data linkage, direct transmission of data, data checking, and others • Developing new indicators of perinatal health: capturing morbidity, CALL FOR ABSTRACTS: positive pregnancy outcomes, & socio-economic inequality and exclusion USE ATTACHED FORM • Translating better statistics into better health: trends in health reporting, the impact of research on policy, and how policymakers use data TO SUBMIT BEFORE • A specialized training workshop for partners who will collect data on 15/02/2006 PERISTAT indicators in the coming year

FOR MORE INFORMATION, The Better Statistics for Better Health congress is hosted by the University CONTACT JENNIFER ZEITLIN AT [email protected] of Porto Medical School Department of Hygiene & Epidemiology, with TEL: +33 1.42.34.55.79 support from the European Commission Public Health Program. The EURO-PERISTAT project is coordinated by INSERM U-149 and Assistance Publique Hôpitaux de Paris.

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statistics FOR

BETTER FOR health pregnant women and their babies Abstract Submission Form Submit this form to Jennifer Zeitlin by 15/02/2006 By email: [email protected] By fax: +33.1.43.26.89.79

Topics for posters/oral presentations:

„ Session one: Innovative methods for improving the quality of data on perinatal health, including: – data linkage – new data sources – new indicators „ Session two: Use of perinatal health data in decision making, including: – case studies of situations in which data were used to change policy – methods for using data to influence policy making

Title of presentation:

Check one:

Session one: data quality Session two: data in decision-making

Would you like to be considered for an oral presentation (20 minutes)?

Yes No, poster only

Presenting author and affiliation:

Other authors:

Abstract (no more than 200 words):

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Understanding differences in perinatal death between countries in Europe: an analysis of risk factors A proposal as part of WP7 of the PERISTAT project

Task Coordinator: KM van der Pal-de Bruin and SE Buitendijk, TNO, Leiden, the Netherlands

The Peristat-study showed that there are considerable differences in the prevalence of perinatal death between countries. For instance, the Netherlands were found to have the highest fetal mortality rate with 7.4 per 1.000 births. It appeared that for the Netherlands the decrease in perinatal death over time had not continued to the same degree when compared to other European countries. Other countries, such as Denmark and Scotland, also had relatively high mortality compared to the European average.

One of the explanations for these differences is that the prevalence of risk factors for poor outcome varies. As shown in the PERISTAT review, the distribution of maternal age, parity and multiple pregnancies is not the same in all European countries (ref Bréart in the EJOG).

Other indicators, such as ethnicity, also vary – although these data are not easy to compare between countries given existing data sources. Another key explanatory item could be the prevalence of congenital anomalies among live births – reflecting differences in practices related to screening and termination of pregnancy.

In the Netherlands, additional analysis was done to achieve more insight into the contribution of several known risk factors for perinatal death. The risk factors under study were parity (primiparous vs. multiparous, core indicator), maternal age (<35 vs. ≥35, core indicator), multiple birth (yes vs. no, core indicator), congenital anomalies (yes vs. no), ethnicity (Dutch vs. non Dutch, recommended indicator, further development required), and assisted conception (yes vs. no, recommended indicator). These data were available from the Dutch Perinatal Database. Logistic regression analysis was done and the odds ratios were changed to relative risks. In addition, population attributable risks (PAR) were calculated.

The univariate analysis showed that all studied risk factors were strongly related to perinatal death. Also, after stratification these strong relations remained The highest relative risk was found for severe congenital anomalies (RR=25,05), followed by multiple birth with an RR of 4.95 (see table). The RR of parity, maternal age, ethnicity and assisted conception was about 1.35.

In total, 45.8% of perinatal deaths were related to the risk factors introduced in the model. For example, parity (nulliparous women, low RR, high prevalence) was found to be related to 14.1% of perinatal death, whereas congenital anomalies (high RR, low prevalence) are related for 7.2%.

Table 1: Risk factors of perinatal death

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Risk factor RR prevalenc Perinatal e death N % Maternal age >35 jr 1.30 14.0 85 4.04 Non-Dutch women 1.37 15.7 115 5.50 Nulliparous 1.35 46.8 296 14.09 Multiple birth 4.95 4.1 293 13.96 IVF/ICSI 1.00 1.5 - - OAR 1.36 2.9 23 1.03 Severe congenital 25.05 0.3 150 7.16 anomalies 962 45.78

The above analysis provides an example of the analysis which we would like to carry out for a sample of European countries. Our aim is to understand better mortality differences between European countries and also to see if including other sub-groups in routine data collection on mortality (such as maternal age) would improve the interpretation of these indicators.

We would therefore like to invite countries participating in the PERISTAT project to join in this collaboration.

Once we identify interested participants, we will send out a list of data items that we would need to obtain for the analyses. We aim to carry out one set of analyses using core data (which most countries have) – maternal age, parity, multiple births and death from congenital anomalies and another using the other variables – if available and comparable – ie ethnicity, pregnancy after IVF.

If you are interested in participating, please contact Karin van der Pal ([email protected]) with copy to Jennifer Zeitlin (zeitlin@cochin.

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