first interim technical implementation report (28-03-07) · wp3: evaluation of the project 10 3....

Contract no.: 2005116 Project acronym: EuroNeoStat Project title: EUROPEAN INFORMATION SYSTEM TO MONITOR SHORT AND

LONG-TERM MORBIDITY TO IMPROVE QUALITY OF CARE AND PATIENT-SAFETY FOR VERY LOW-BIRTH-WEIGHT INFANTS

Instrument: PROGRAMME OF COMMUNITY ACTION IN THE FIELD OF PUBLIC

HEALTH (2003-2008)

FIRST INTERIM IMPLEMENTATION REPORT Period covered: from 01/01/06 to 31/12/06 Date of preparation: 01/02/07 Start date of project: 01/01/06 Duration: 36 months Project coordinator name: Prof. Adolf Valls i Soler Project coordinator organisation name: Fundación Vasca de Innovación e Investigación

Sanitarias (BIOEF)

INDEX:

1. PROJECT OBJECTIVES AND MAJOR ACHIEVEMENTS 3

1.1. Overall objectives 3

1.2. Major achievements 4

2. CONSORTIUM MANAGEMENT 5

2.1. WP1: Co-ordination of the project 5

2.2. WP2: Dissemination of results 8

2.3. WP3: Evaluation of the project 10

3. TECHNICAL PROGRESS OF THE PERIOD 11

3.1. WP4: Neonatal morbidity indicators 11

3.2. WP5: Standardised comparisons of morbidity outcomes 14

3.3. WP6: Minimal dataset of follow-up indicators 17

3.4. WP7: Outcome research 18

3.5. WP8: EuroNeoSafe: a Patient Safety Initiative 19

3.6. WP9: Software and Website 20

4. ACTUALISED TIME SCHEDULE 23

ANNEXES: ANNEX 1.- Deliverable 1: Kick-Off Meeting Minutes ANNEX 2.- Deliverable 2: 6th Month Management Meeting Minutes ANNEX 3.- Deliverable 3: 10th Month Management Meeting Minutes ANNEX 4.- Deliverable 4: EuroNeoStat Perinatal Dataset 2006 ANNEX 5.- Deliverable 5: Standard Comparison Protocols 2006

1. Project objectives and major achievements

1.1. Overall objectives The ultimate strategic goal of the project is to develop an Information System to assess and improve quality of the health care given to very premature infants (gestation <32 wks) or of Very-Low-Birth-Weight Infants (VLBWI; birth weight <1.500 g) in European Neonatal Intensive Care Units (NICU), institutions, regions and countries. Specifically, we aim to reduce their neonatal morbidity and mortality, improve patient safety and health status at 2 years and to detect variability of clinical practice and outcome inequalities that might exist among neonatal units. To achieve those aims, we propose to design and validate a standard set of birth weight and gestational age specific neonatal indicators and implement it to feed a database collecting real data from the NICUs participating in the project. We plan to establish and maintain a data-base with a set of prenatal events, neonatal interventions and neonatal and long-term outcomes to asses the quality of care of the participating NICUs. Collected data could also be used by health authorities to take decisions related to health programs and policies to improve the care of VLBWI. The project hopes to contribute to improve the quality and safety of the health care provided to VLBWI and their families by:

1. Data collected could be of use by NICUs to compare their results to those of other institutions, by applying the same criteria (“benchmarking”), to identify areas with opportunities to improve care, and to monitor the success of the quality-improvement and patient safety effort to achieve those aims (“internal audit”).

2. The indicators developed could be used by health organisations to evaluate the health programs, resources, and priority settings dedicated to short- and large-term care of VLBWI.

3. Knowledge of clinical variability of the care process and outcomes could provide insights into better ways to deliver care and to promote wide-scale consensus in policies and strategies to be use for care of VLBWI.

4. The empirical proof of the hypothesis that gestational age rather than birth weight should be used as a risk indication. Weight has been traditionally used since is easily measure, but does not truly reflect the degree of maturity. Gestational age is now routinely and precisely measured by early foetal sonography.

To achieve aims above, we plan to collect data from some 3.000-4.000 VLBWI from more than 50 institutions, from associate and Collaborative partners, as well as from some regional (Liverpool, Basque Country and Navarre,...), and national networks (Spain, Portugal, Switzerland, Finland,…). As mentioned before, the first objective is to create and validate a set of neonatal indicators to evaluate both, process and outcome by birth weight and gestational age specific rates of neonatal and post-neonatal mortality and morbidity. The following secondary objectives will also be pursued:

1. To develop standardised morbidity indicators, to assess the health care process and outcome results between participating units over time (benchmarking). In selected regions, in which a quasi-population-based data will be gathered, inter-regional comparisons will be performed to identify differences in outcome related to clinical variability. The indicators will also help units to identify areas with opportunities to improve quality-of-care (external audit), and to monitor the success in their improvement efforts. If significant clinical variability among centres if found, nested studies will be proposed to identify factors that could be responsible for the observed differences.

2. To assess clinical variability among units of the different strategies and interventions used, to know what are doing in the care delivery process of the VLBWI assisted.

3. To test the hypothesis that gestational age is a better indication for short- and long-term mortality and morbidity risk than birth weight. Weight-specific indicators are use by existing networks, since its recording is judged more accurate. However, now very early foetal sonography precisely determines gestational age within a week.

4. To develop and validate a minimal follow-up dataset, to assess the health status of

surviving infants at 24 months of corrected age. An expanded questionnaire, to more precisely assess the health status will also be developed, and tested at selected units or areas with existing follow-up programs (Madrid, Liverpool and Bilbao hospitals).

5. To test the value of the perinatal indicators to predict the gestational age-specific health status of survivors at 24 month of corrected age.

6. To develop the necessary software and informatics tools to record, transfer, validate, standardise and compare the perinatal and follow-up data collected, by use of up-to-date, Internet-based technologies to facilitate incoming flow of data and the outflow of standardised comparative results.

This project could ultimately contribute to consolidate “EuroNeoNet”, a platform affiliated to the European Society for Neonatology (ESN/ESPR) for the:

1. Enhancement of networking to help neonatal professionals to promote a culture for quality of care improvement and a patient safe, family-cantered and developmental care.

2. Dissemination of evidence-based interventions by e-learning, evaluate clinical variability.

3. Dissemination results in professional meetings and effectively conducting academically-driven clinical trials, case-control, cohort, clustered and nested studies.

1.2. Major achievements The specific achievements for the first year of the project are summarised in the table below:

Task: Achievement: Deliverables: Nature WP1. Co-ordination of the project

Management, evaluation and dissemination agreements • Kick-Off Meeting Minutes Report

WP1. Co-ordination of the project

Initial Phase management, dissemination and evaluation report

• 6th Month Management Meeting Minutes


Report

WP4: Neonatal morbidity indicators

Set of indicator of perinatal morbidity for data collection during Pilot Phase

• EuroNeoStat Perinatal Dataset 2006

Data set

WP5. Standardised comparisons of morbidity outcomes

Standard comparison protocols at NICU, regional and national levels

• Standard Comparison Protocols 2006 Report

2. Consortium Management

2.1. WP1: Co-ordination of the project Responsible partner:

• Fundación Vasca de Innovación e Investigación Sanitarias Involved partners:

• All Associated Partners Objective: The main objectives of this WP are:

• To establish a co-operation agreement amongst the partners. • Preparation of technical and committee meetings. • Maintain a continuous communication line and helpdesk for all project related issues for

all partners and interested parties. Progress: The first action in this WP was the establishment of the project Management Structure and the decision making policy and mechanisms. Those are the following:

A) Management Board or Steering Committee: It is in charge of taking all the strategic decisions of the project. 15 members representing 12 Associated Partner Organisations compose the Steering Committee, and it is chaired by Prof. Adolf Valls i Soler. There will be two general types of decisions:

Scientific or technical decisions. In these voting all member of the Steering Committee will represent 1 vote with a total of 15 votes.

Non-scientific or technical decisions. In these voting each Associated Partner Organisation with representatives in the Steering Committee will represent 1 vote with a total of 12 votes. In the case of those Associated partner organisations with 2 members in the Steering Committee the vote shall be given under consensus between both members.

The chairman of the Management Board will be the project leader and will be composed by the following members of each Associated Partner Organisations in the consortium:

Member of the

Steering Committee Associated partner organisation

1 Prof. Adolf Valls i Soler 2 Dr. Jose Ignacio Pijoán

Hospital de Cruces (BIOEF) 1

3 Dr. Helmut Hummler Children’s Hospital, University of Ulm 2 4 Prof. Mikko Hallman University of Oulu 3 5 Dr. Carlo Corchia 6 Dr. Marina Cuttini

Bambino Gesù Children’s Hospital 4

7 Prof. Gunnar Sedin Uppsala University Children’s Hospital 5 8 Dr. Tom Arne Stiris Ullevaal University Hospital 6 9 Dr. Carmen Rosa Pallás10 Dr. Javier de la Cruz

Hospital 12 de Octubre 7

11 Dr. Virgilio Carnielli Azienda Ospedaliero-Universitaria Riuniti 8 12 Prof. Michael Weindling University of Liverpool 9 13 Prof. Olivier Claris University of Lyon 10 14 Dr. Harry Molendijk Isala Klinieken 11 15 Prof. Henry Halliday Queen’s University Belfast 12

B) Decision Making Mechanism. In both kind of decisions (technical and non technical) decisions will be made ordinarily during Steering Committee meetings (meeting calls must be done at least 30 days before). Resolutions can be passed with the majority with the participation in the decision of at least 2/3 of votes (including vote delegations) and in the case of tie the decision will be taken by the Chairman. Steering Committee members can suggest a Deputy always empowered with a valid vote delegation document. In special cases decisions of the Steering Committee shall be taken by written electronic (e-mail) confirmation and always all members of the Steering Committee agree with this procedure in those special cases.

C) Scientific Manager: Prof. Adolf Valls i Soler, responsible for the day to day management

and decisions related to scientific issues. All day to day decisions in this competence field will be taken following the criteria of the Scientific Manager but always following the directions of the Steering Committee.

D) Chief Epidemiologist: Dr. Jose Ignacio Pijoán, responsible for the day to day

management and decisions related to epidemiological issues. All day to day decisions in this competence field will be taken following the criteria of the Chief Epidemiologist but always following the directions of the Steering Committee.

E) Dissemination Committee: Structure for the advisory and control of publications and

dissemination of results of the project but with no ability to make decisions in this field being an exclusive competence of the Steering Committee.

Dissemination Committee leader: Prof. Henry Halliday. Dissemination Committee members: Dr. Helmut Hummler, Prof. Adolf Valls i Soler,

Dr. Javier de la Cruz.

F) Woking Groups. Although all Associated and Collaborative partners are directly or indirectly related to all WPs of the project, for the practical development of project activities the consortium established different Working Groups with the respective Working Group leaders. Each Working Group leader will be responsible for the definition of the decision making mechanism in each Working Group but all decisions will always follow the directions of the Steering Committee, Scientific Manager and Chief Epidemiologist. Activities for the development of the project will be executed by three Working Groups:

WG1: Perinatal dataset and Benchmarking. Will be responsible for the execution of the following work packages:

WP-4: Perinatal Dataset WP-5: Standardised comparison of outcomes WP-7: Outcome research

The members of this Working Group are: WG1 Leader: Prof. Adolf Valls i Soler. WG1 Members: Prof. Mikko Hallman, Prof. Gunnar Sedin, Dr. José Ignacio

Pijoán, Dr. Tom Stiris, Dr. Carlo Corchia, Dr. Marina Cuttini, Dr. Virgilio Carnielli, Dr. Carmen Pallás, Dr. Javier de la Cruz.

WG2: Follow up: Will be responsible for the execution of the WP-6: Minimal Follow up dataset. The members of this Working Group are:

WG2 Leader: Prof. Michael Weindling. WG2 Members: Dr. Javier de la Cruz, Dr. Carmen Pallás, Prof. Gunnar

Sedin, Dr. José Ignacio Pijoán, Dr. Tom Stiris, Dr. Marina Cuttini. WG3: Patient Safety: Will be responsible for the execution of WP-8: EuroNeoSafe.

The members of this working group are: WG3 Leader: Dr. Harry Molendijk. WG3 Members: Dr. Carmen Pallás, Dr. Tom Stiris, Dr. Carlo Corchia, Dr.

Virgilio Carnielli, Dr. Michael Weindling. WG4: Software: Will be responsible for the execution of the WP-9: software and

website. The members of this working group are: WG4 Leader: Prof. Adolf Valls i Soler. WG4 Members: Technical and Coordination Centre to be established in

Bilbao (Hospital de Cruces).

During 2006 the project management and development required 3 meetings. • The Kick-Off Meeting, held on 20th–21st January 2006 in Bilbao (Spain). This meeting

is the first milestone of this WP defined in the original work programme as Initial Phase Kick-Off Meeting.

• A 6th Month Management Meeting, held on 23rd May 2006, in Prague (Czech Republic). This meeting corresponds to the second milestone of this WP defined in the original work programme as Pilot Phase Kick-Off Meeting.

• A 10th Month Management, held on 11th October 2006 in Barcelona (Spain). This meeting was not foreseen in the original work programme but, due to the delay in the signature of the project contract, and the relative inexperience of several project partners in EC funded project the Steering Committee considered the meeting strongly necessary to discuss and clarify all doubts of the partners.

Pending milestones are:

Date Milestone

Month 19 Full Phase Kick-Off Meeting

Month 31 Full Phase First Annual Management Meeting

Month 36 Project Final Meeting Initially all project meeting where expected to be held in Bilbao but the Consortium tried to meet project meetings with other Europe wide events on Paediatrics like the Congress of the European Association of Perinatal Medicine (EAPM) in Prague and the EuroPaediatrics Congress of ESPR/ESN in Barcelona. This makes that Fundación Vasca de Innovación e Investigación Sanitarias, the Project Leader, have to request to the EC a reconfiguration in their budget structure to allocate resources for the derived new travel and subsistence costs because neither meetings nor expenses away from Bilbao were considered originally. The main achievements and deliverables generated on this WP during 2006 are:

Achievement: Deliverables: Nature





Report

Pending deliverables are:

Deliverable No Deliverable title Delivery date

D 5 Pilot Phase Management, Evaluation and Dissemination Report Month 19

D 11 Full Phase First Year Management, Evaluation and Dissemination Report Month 31

D 15 Project Final Management, Evaluation and Dissemination Report Month 36

2.2. WP2: Dissemination of results Responsible partner:


• All Associated and Collaborative Partners Specific Working Group:

• Queen’s University of Belfast. • Universitätsklinik für Kinder- und Jugenmedizin (University of Ulm). • Fundación Vasca de Innovación e Investigación Sanitarias. • Fundación para la Investigación Biomédica del Hospital Universitario 12 de Octubre.

Objective: The general objective of this WP is to maximize the dissemination of project results but always taking into account that: the level of expertise of each selected audience, the objectives of an efficient communication with the audience, confidentiality of personal and scientific information. Therefore the specific objectives are:

• To develop and agree a dissemination strategy. • Define and agree rights and obligations related with dissemination of results for each

partner organisation depending on the nature of such organisation. • Develop, present and discuss the information about results of the project for the general

public audience. • Develop a final dissemination strategy to access to alternative funding sources to

assure continuance once the project finishes. Progress: As mentioned before a Dissemination Committee has been established for:

• Development of publication and dissemination strategies. • Control of publication and dissemination of project results. • Acting as advisory group for members (and others) wishing to publish results from the

project. During 2006 the Dissemination Committee stated with the development of a complete and detailed Dissemination plan but it has not been yet completed. The main aspects considered in the initial draft of the plan are:

• Internal dissemination will be responsibility of the main partner. • External dissemination will be performed by all partners with the support of the

Dissemination Committee. • Partners initially will focus their dissemination activities in their domestic audiences, and

after this experience, will increase the dissemination field to other international audiences covering in this manner almost all countries in Europe.

• There will be two main potential audiences: 1. The scientific community. The consortium will develop an strategy and a policy

to define the rules, rights and obligations of each partner to avoid conflicts among partners when target audience is the Scientific Community.

2. The general public. Dissemination to general audience will be made upon consensus of the entire consortium and will be done by the main partner.

• Main dissemination platforms are expected to be: o Presentations at neonatal and perinatal meetings o Publications in journals – paper and electronic o Seminars, symposiums, conferences and forum o Internal and external dissemination - newsletters o Roles of all the partner organisations o Scientific community and general public

• Main Types of expected dissemination vehicles are: o Epidemiological studies o Audit and quality assurance studies o Observational studies

o Case-control studies o Cohort studies o Randomized controlled studied

The development of the Dissemination Plan still has not been completed, thus the first expected milestone of the WP, Development of detailed Dissemination Plan, will be delayed to 2007. On the other hand, first dissemination actions have been conducted and the second milestone of the WP, Dissemination of Initial Phase Results, has been adequately reached. Main dissemination actions have been:

• A presentation of the project done at the Congress of the European Association of Perinatal Medicine (EAPM) in Prague.

• Attendance to meetings of EUROCAT and EUROPERISTAT projects for Dissemination of EuroNeoStat project and Coordination with these projects.

• Also the beginning of the project ahs been publicised in several specialised and general purpose publications in Spain.

Thus, pending milestones are:

Date Milestone

Month 24 Development of detailed Dissemination plan

Month 21 Dissemination of Pilot Phase Results

Month 33 Dissemination of Full Phase Fist Year Results The main achievements and deliverables generated on this WP during 2006 are:






Report






2.3. WP3: Evaluation of the project Responsible partner:


• All Associated Partners Objective: The general objective of this WP is to maintain a continuously active process to identify, analyse and report any deviation from the expected path of the project in order to react efficiently as soon as any problem is detected. For that purpose, the specific objectives of this WP are:

• The development of an agreed evaluation strategy that involves all partners and the EC. • The definition of an evaluation procedure based in a pyramidal sequence of validations,

and information flows, from the auto-evaluation of each partners activities, to the periodic evaluation of the overall project execution at the management meetings.

• The continuous evaluation based on the previous strategy and procedures. Progress: The developed and agreed evaluation strategy for the project is focused in two main indicators:

1) The execution of the project, measuring continuously the advancement of the project in relation with the original work-plan. This indicator will be measured with:

a. Fulfilment of project deliverables. b. The internal dissemination of project deliverables. c. Delivery of deliverables to EC.

2) The appropriateness of developments done for the consecution of project objectives. This indicator will be measured via the discussion about deliverables in Project Meetings.

At this stage all project deliverables have been prepared and submitted to the partners and EC with the exception of the Interim Consolidated Financial Statement, required in the contract with the EC. This situation comes once again from the severe deviation from the project beginning date and the signature of the project contract and the inexperience in EC funded projects of most project leaders of the Associated Partner organisations. Due to this delay in the delivery of the Financial Statement the Project Leader had to submit to the EC two written requests asking for the delay in the due date for this document. On the other hand, the main result presented and discussed in the project meetings has been the Set of Indicators for data collection, and this means that the expected milestone of this WP during 2006 has been adequately reached. Thus, pending milestones are:

Date Milestone Month 19 Evaluation of data collection and analysis at Pilot Phase

Month 31 Evaluation of data collection and analysis at Full Phase

Month 36 Final Evaluation of the project The main achievements and deliverables generated on this WP during 2006 are:

Achievement: Deliverables: Nature Management, evaluation and dissemination agreements • Kick-Off Meeting Minutes Report


• 6th Month Management Meeting Minutes • 10th Month Management Meeting Minutes

Report




D 9 Agreed public contents about Pilot Phase results for each selected target audience Month 21


D 14 Agreed public contents about Full Phase results for each selected target audience Month 33


3. Technical progress of the period The following summarises the work carried out over the first year of the project. Further details are given in the detailed reports on the tasks, which can be found in the appendices.

3.1. WP4: Neonatal morbidity indicators Responsible partner:



• Oulun Yliopisto • Uppsala Universitet • Ullevål Universitetssykehus • Ospedale Pediatrico Bambino Gesú • Azienda Ospedaliero-Universitaria Riuniti Umberto I, G. M. Lancisi, G. Salesi. • Fundación para la Investigación Biomédica del Hospital Universitario 12 de Octubre

Objective: The main objective of this WP is to collect data from all live-born newborn infants with a birth weight below 1,500 g and/or a gestational age less than 32 completed weeks, born and cared at participating units. A total of about 80 perinatal and neonatal events, interventions and outcome variables will be initially included in the dataset, after approval of their precise definitions. These data will be collected following a set of neonatal indicators, designed within the project, and being also one of the main results, to assess both the neonatal health care process and the birth weight and gestational age specific rates of neonatal and post-neonatal mobility of immature infants. Once collected, data will be validated to assure its quality and completeness and then, weight and gestation-specific morbidity rates will be calculated after standardisation. After two year of data collection, the consortium will be in the position to evaluate the use of gestational age rather than birth weight as a major specific risk indicator for morbidity of VLBWI. This is because weight its easily and precisely measured, but does not truly reflects the degree of maturity of the newborn, been influenced by intrauterine growth (30% of VLWI are under-grown at birth). Gestational age, is now routinely used, and precisely measured by early foetal

sonography. Moreover, we will also evaluate the combined use of birth weight and gestational age, since maybe babies of a gestation <32 wks, even if weight over 1,500 g, might have a greater risk than those below this weight, if are more mature. These strategies could allow to independently evaluate the two main cellular and biological foetal process, growth and maturation. Progress: Initially in the WP a draft set of indicators and definitions were designed, presented and circulated. After intense and interesting discussions during the Kick-Off Meeting and the 6th Month Management Meeting a final complete set of neonatal indicators was designed and agreed. Thus first two milestones of the project, Development and circulation of draft indicators and Development of full set of indicators have been adequately reached. After the design of the data set the Partners started with the process of data compilation and transfer to the central data managing unit in Bilbao, where data quality is validated and the database is fed. Data compilation is based on identification of all live-born VLBW in participating units, and its prospective recording from birth to either death or discharge from unit. The project partners guarantee that:

• No data that could directly or indirectly identify individual patients will be used. • All procedures will adhere to international protection data and personal identity

legislation. • Partners will guarantee the security of the database, which will not be used for other

that the specific project objectives. At this moment the work within this WP is focused in the compilation, transfer and reception of data until month 18. All partners of the project are involved in this process and it is the main time and resource consuming process of the project. Three platforms have been developed for the transfer of data:

• Paper form. The partners delivers data in a form (paper or pdf) to the Bilbao Coordinating Office and there an special hardware-software system that reads, validates and adequates the data to feed the central database.

• Electronically (Data Pic): The partner uses a software developed within the project for the entry packaging and delivery of the data. Includes a first quality control at data entry.

There is another option which would be the most desirable case. The partner could directly extract from its actual databases a file which is compatible with the central database at Bilbao

Coordinating Office containing the data. In order to make this possible, the databases of the partner should include all data included in the designed data set and an specific software development should be needed. The costs of these specific software developments make them worth only if the partner could retrieve a notable amount of cases, for example in a regional or national wide database but not for a single small NICU. Several cases of this nature are under study at the moment. The following figure summarises the different choices.

Once the data is received in the Bilbao Coordinating Office all data is quality checked automatically:

• To detect missing, erroneous and inconsistent values detected (e-check) • Data verification previous to analysis (SPSS-pc) • Odd pattern verification (SPSS-pc)

From the point of view of security the Central Database developed in the Coordination Office has implemented the following protocols:

• Physical Security Protocol: The Global DB is saved in an External Hard Disk physically locked. Only the

leader and the technician have the key. There is a mirror structure, so the HD is divided in two and when a change is

made in one, the other one recalls it. Copies are done weekly, so loss of data only implies a week of work.

• Logical Security Protocol: Data saved in the Hard Disk is logically locked. Again only the leader and the

technician know which is the alphanumerical code. Algorithms used to lock the BD are SHA-1 and RC4 (160 bits).

The following table shows the status of the data gathering process by the end of 2006:

NICU Contacted Surveys Data Plan Received Data FINLAND √ NO SHEET/ELECTRONICALLY √ FRANCE √ √ ELECTRONICALLY NO GERMANY √ NO ELECTRONICALLY √ ITALY (ANCONA) √ √ ELECTRONICALLY √ ITALY (ROME) √ √ SHEET/ELECTRONICALLY √ NORWAY √ √ ELECTRONICALLY NO SPAIN (CRUCES) √ √ SHEET/ ELECTRONICALLY √ SPAIN (MADRID) √ √ SHEET √ SWEDEN √ √ ELECTRONICALLY NO THE NETHERLANDS √ NO ¿? NO UK (BELFAST) √ NO SHEET √ UK (LIVERPOOL) √ √ ELECTRONICALLY NO AUSTRIA √ √ ELECTRONICALLY/SHEET √ BELGIUM √ √ ELECTRONICALLY √ CZECH REPUBLIC √ √ ELECTRONICALLY √ GREECE √ NO SHEET/ELECTRONICALLY √ HUNGARY NO NO ¿? NO IRELAND √ √ ¿? NO POLAND √ √ SHEET √ PORTUGAL √ NO ELECTRONICALLY √ ROMANIA √ NO ¿? NO RUSSIA √ NO SHEET/ELECTRONICALLY √ SWITZERLAND √ √ ELECTRONICALLY √ TURKEY √ √ SHEET NO UK (SOUTHAMPTON) √ NO ¿? NO

Almost all partners have been contacted, have fulfilled a survey to characterise de situation and capabilities of the NICU and have selected the most appropriate data transfer system for their

ADVANTAGES DISADVANTAGES

SHEET COMFORTABLE FOR UNITS SHEET MUST BE READ NOTIN COORDINATOR CENTRE

DATAPIC COMFORTABLE FOR UNITS COMFORTABLE FOR COORDINATOR CENTRE

ELECTRONICALLY COMFORTABLE FOR UNITS FORMAT MATCH

COLLECTION METHODS

needs. The situation of data reception on October 2006 is shown in the next figure. Nowadays collected data is significantly richer than the shown in the table above. :

Summarising, main achievements and deliverables generated on this WP during 2006 are:


Set of indicator of perinatal morbidity for data collection during Pilot Phase

• EuroNeoStat Perinatal Dataset 2006

Data set

Pending milestones are:

Date Milestone

Month 18 First year of data Collection, Pilot Phase

Month 19 Validation and correction of full set of indicators

Month 30 Second year of data collection, Full Phase



D 6 Set of indicators of perinatal morbidity for data collection during the Full Phase Month 19

D 16 Database with neonatal data collected during the Full Phase (in advance of month 12 of collection)

Month 36

3.2. WP5: Standardised comparisons of morbidity outcomes

Responsible partner: • Fundación Vasca de Innovación e Investigación Sanitarias (BIOEF)

Involved partners:

• All Associated Partners Specific Working Group:

• Oulun Yliopisto • Uppsala Universitet

TOTALGERMANY 48 GREECE 36ITALY (ROME) 30 POLAND 15SPAIN (CRUCES) 55 RUSSIA 32SPAIN (MADRID) 17UK (BELFAST) 58TOTAL 208 TOTAL 83 291

Nº OF DATA RECEIVED (2006)ASSOCIATED COLLABORATIVE

• Ullevål Universitetssykehus • Ospedale Pediatrico Bambino Gesú • Azienda Ospedaliero-Universitaria Riuniti Umberto I, G. M. Lancisi, G. Salesi. • Fundación para la Investigación Biomédica del Hospital Universitario 12 de Octubre.

Objective: The main objective of this WP is to allow partner units to perform standardised mortality and morbidity outcome comparisons to other units of similar in size or level of care, and to those of all units polled together. These will allow them to identify differences in clinical practices, morbidity outcomes, identify areas with opportunities to improve quality of care and to latter monitor the success of their quality improvement initiatives. To develop a summary report with results from all participating units, that could be used by any other NICU from Europe or else ware to know its relative position for any of the items included in the perinatal dataset. Progress: This WP has started on month 7 as expected in the original work plan. Initially in this WP several checks and simulations of data analysis were done based on with the received data. These simulations were done to be shown in the project meetings with the following objectives:

• They have an initial validation of the quality of the designed data set. • To have a reference to enrich the discussion about this WP during the meetings.

The most representative work done with these purposes was the simulations done for the 10th Month Management Meeting in Barcelona. The Statistical reports performed for the Barcelona ENS Meeting were:

• 1) General descriptive analysis (descriptive analysis for VLBWI from the first two quarters; 18 pages).

• 2) General Report for VLBWI from the first two quarters of 2006 that includes an individualised analysis for each Unit and comparisons between them (51 pages).

• 3) Analysis shown in this presentation which illustrate different ways of displaying results. (23 pages).

The following figures show several results of this study:

A 2,4% of the infants weight studied is under 501 grams and more than a half of the population is under 1250 grams (55,9%).

Nº % % Acum.< 501 g. 7 2,4 2,4501-750 g. 32 11,1 13,5751-1000 g. 64 22,2 35,81001-1250 g. 58 20,1 55,91251-1500 g. 96 33,3 89,2> 1500 g. 31 10,8 100TOTAL 288 100

Birth Weight (Categories)

Male Female TotalBirth Weight N 146 141 288

Mean ± s 1186 ± 330,5 1131,6 ± 339,5 1157,3 ± 336,595% IC [1131,9;1240] [1075,1;1188,1] [1118,3;1196,3]Median 1210 1145 1190[Q1;Q3] [947,5;1390] [872,5;1390] [920;1390]

Gestational Age (Weeks) N 146 141 288Mean ± s 28,9 ± 2,5 28,5 ± 2,7 28,7 ± 2,695% IC [28,4;29,3] [28,1;29] [28,4;29]Median 29 29 29[Q1;Q3] [27;31] [26;31] [27;31]

Prenatal Steroids N 140 138 278None (%) 28,6 28,3 28,4Incomplete (%) 24,3 26,8 25,5Complete (%) 47,1 44,9 46,0

Delivery Room Resuscitation N 141 139 280Yes (%) 84,4 85,6 85None (%) 15,6 14,4 15

Multiple Birth N 146 141 287Yes (%) 36,3 35,5 35,9No (%) 63,7 64,5 64,1

Infant Characteristics

One the VLBWI doesn't have SEX is still being checked

14,6% of the infants admitted from January 1st to September 25th, have died. One of these infants, died in the delivery room. According to birth weight, mortality rates decrease when birth weight increases.

TotalNº % Nº % Nº

< 501 g. 5 71,4 2 28,6 7501-750 g. 12 37,5 20 62,5 32751-1000 g. 16 25 48 75 641001-1250 g. 4 6,9 54 93,1 581251-1500 g. 4 4,2 92 95,8 96> 1500 g. 1 3,2 30 96,8 31TOTAL 42 14,6 246 85,4 288

Yes NoMortality By Birth Weight Categories

Differences between Units were statistically significant for Unit 1 (U Mann Whitney p_value = 0,005).

Taking reference from this initial works and the discussion and suggestions of project partners at the end of the year a complete initial set of a Standard Comparison Protocols at NICU, Regional and National Levels have been developed. This Protocols are those which are going to be implemented via software to allow automated and fast comparisons at different levels and depending the interest of the end user of the information:

• Chief of NICUs of Paediatric services. • Regional, National or European policy makers. • Statisticians and developer of studies for general dissemination. • Researchers.

The access rights and levels to these data and automated comparisons is a point to be defined later on the project. Summarising, main achievements and deliverables generated on this WP during 2006 are:


Standard comparison protocols at NICU, regional and national levels

• Standard Comparison Protocols 2006 Report

Thus pending milestones are:

Date Milestone

Month 19 Comparative analysis of Pilot Phase data

Month 24 Validation of standard comparison protocols

Month 31 Comparative analysis of first year of Full Phase data

Expected deliverables are:


D 7 Standard Comparison of Perinatal Morbidity of individual NICU at Pilot Phase Month 19

D 12 Standard Comparison of individual NICU at Full Phase and Overall Comparison Report

Month 31

3.3. WP6: Minimal dataset of follow-up indicators Responsible partner:

• The University of Liverpool Involved partners:

• All Associated Partners Specific Working Group:

• Fundación para la Investigación Biomédica del Hospital Universitario 12 de Octubre • Uppsala Universitet • Fundación Vasca de Innovación e Investigación Sanitarias • Ullevål Universitetssykehus

• Ospedale Pediatrico Bambino Gesú Objective: The objective of this WP is to develop and validate a minimal follow-up dataset of indicators to assess quality of life of VLBWI at 24 months of corrected age. The recording of the perinatal and follow-up datasets will permit to study the capacity of the perinatal indicators to predict the health status at 2 years. Moreover, a more detailed toll to assess the health status at follow-up at 24 months of corrected age will also be developed and evaluated. Progress: Even if this WP were expected to be stated on month 12 in practice it started on month 7. The working group in this WP have started their activity y with the development of a first initial version of follow-up data-set which has been intensely discussed during the project meetings. The main discussion point is the scope of the follow-up were one of the schools of thought considers that this must be very optimised and easy to be fulfilled on order to reach all cases and the other one considers it should be very exhaustive even if it would suppose a big following cost both for parents and medicine professionals. Expected milestones are:

Date Milestone

Month 19 Development of minimal follow-up data set

Month 24 Development of expanded follow-up data set

Month 36 Collection of 24th month follow up data

Month 36 Analysis of follow-up data Expected deliverables are:


D 10 Final minimal and expanded working follow-up dataset for infants at 24 months

Month 24

D 17 Database with collected follow-up data of infants at 24 months

Month 36

3.4. WP7: Outcome research Responsible partner:



• Oulun Yliopisto • Uppsala Universitet • Ullevål Universitetssykehus • Ospedale Pediatrico Bambino Gesú • Azienda Ospedaliero-Universitaria Riuniti Umberto I, G. M. Lancisi, G. Salesi. • Fundación para la Investigación Biomédica del Hospital Universitario 12 de Octubre.

Objective: The main objectives of this WP are:

• To use the perinatal indicators to monitor and quantify clinical variability among centres, and if found, nested studies will be proposed to identify the factors that could be responsible for the observed differences.

• To test the hypothesis that gestational age is a better indication for short- and long-term mortality risk than birth weight for VLBWI.

• To use of the perinatal indicators to attempt to predict the health status at 2 years. It is true that genetic, socio-economical, educational, cultural and other postnatal factors determine the health status in early infancy as it those latter on in life. However, it is also true that prenatal, perinatal and neonatal events also influence this status; ands so it could be use to predict health status at 2 years of corrected age.

Progress: This WP is expected to be initiated on month 19. Expected milestones are:

Date Milestone

Month 24 Selection of clinical variability and predictive studies

Month 36 Proposals to improve quality of care: unit, region, nation Expected deliverables are:


D 13 Full proposals for selected clinical variability studies

Month 31

D 18 Overall follow-up data report and proposals to improve quality of care: unit, region, nation

Month 36

3.5. WP8: EuroNeoSafe: a Patient Safety Initiative Responsible partner:

• Isala Kilinieken Involved partners:


• Fundación Vasca de Innovación e Investigación Sanitarias. • Fundación para la Investigación Biomédica del Hospital Universitario 12 de Octubre. • Ullevål Universitetssykehus. • Ospedale Pediatrico Bambino Gesú. • Azienda Ospedaliero-Universitaria Riuniti Umberto I, G. M. Lancisi, G. Salesi. • The University of Liverpool.

Objective: The objective of this WP is to promote a patient-safety culture at participating NICUs, by establishing a voluntary, blame-free reporting system for adverse events (incidents and near-incidents). An interned-based system to house the safety information will also be created. This system will enable accelerated learning from the adverse events reported for all medical and nursing staff at participating units. We aim to promote patient safety by establishing an internet-based exchange of safety information derived from a system of voluntary, blame-free reporting of adverse events at the units level, under the name of EuroNeoSafe. Dr. H. Molendijk has developed such an initiative (Neosafe) in 9 out of 12 eligible Dutch units will participate in a

nationwide project. Progress: This WP was expected to be started on month 7 but in practice the beginning has been delayed to the month 12 due to difficulties of the WG leader to initiate the development. There are no results to highlight in the WP at this stage of the project. Expected milestones are:

Date Milestone

Month 19 Development of patient safety set

Month 36 Patient safety data collection and analysis

Expected deliverables of this WP are


D 19 Adverse Report Form and Annual Report of Incidents and Suggestions

Month 36

3.6. WP9: Software and Website Responsible partner:



• Fundación Vasca de Innovación e Investigación Sanitarias Objective: The main objective of this WP is to develop the necessary software and informatics tools to record, transfer, validate, standardise and compare the perinatal and follow-up data collected, by use of up-to-date, ICT to facilitate incoming flow of data and the outflow of standardised comparative results. Progress: At this stage of the project several development have been done within this WP. Initial developments during 2006 have been:

• Design, develop and implement solutions for the data transfer from the partner NICUS to the Central Coordination Office in Bilbao. As mentioned before:

Paper forms (standardised), to be received by mail and read by special OTC scanner (controls & entered DB)

Data Entry: essentially it is a local database with an implementation of the designed data set where the user introduces directly the data on newborns and allows to export compatible files with the central database.

Data Pick: which is a concept where the each NICU sends its DB structure and the co-ordinator centre finds the best way to match it with ENS DB format. It implies a specific software development for each case. Several cases under evaluation, depending on the potential impact on number of cases caught with the development of this software.

• Design, develop and implement a Central Database according to the data set of neonatal indicator developed within the project.

• Design, develop and implement automated quality checks for the validation of data

before entering them to the central database.

With these initial developments a basic infrastructure has been developed and the central coordination office is in the position to receive, check and store the data securely on a non automated manner but enables the ongoing of the project. Also in this WP the following actions have been completed:

• EuroNeoStat has been registered as European trademark. • A specific logo for EuroNeoStat project has been developed. • www.euroneostat.org website address has been registered and acquired. • The required minimum networking platform has been established in the Central

Coordination Office. This infrastructure allow the future implantation of the web-based automatic IT System defined as the main objective of the project where all partners and future users will:

o Introduce the data on newborns (automatic upload for big units or direct website data entry for small units)

o Access to public statistics and comparisons. o Access to the documents for the dissemination of results. o Define queries and receive results form the central database (depending on the

access right level of the user. Also the integration of EuroNeoStat dataset with existing commercial or free software used by a number of neonatal units in Europe like Badger system, NeoSoft, Neolink 2000, SEN-1500 is under study at this stage. Finally, the specification of the web-based automatic IT System has been developed and the nowadays a subcontracted software programming company is developing the system. The analysis of the IT need and design of the architecture and the specifications of the hardware and software system needed to fulfil the project objectives have been developed with the collaboration of a specialised subcontracted company. Therefore first milestone of this WP, Development of specifications of IT tools, has been adequately reached. Pending milestones are:

http://www.euroneostat.org/

Date Milestone

Month 19 Completion and validation of software development

Pending deliverables of this WP are:


D 8 Internet Platform for data collection, comparison and dissemination and Data Extraction Client Soft.

Month 19

4. Actualised time schedule Mainly due to changes on WP6 and WP8 the new time schedule of the project is the following:

Start date End date 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36

WP1 1 36 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

WP2 1 33 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

WP3 1 36 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

WP4 1 36 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

WP5 7 31 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

WP6 7 36 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

WP7 19 36 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

WP8 12 36 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

WP9 1 18 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

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

first interim technical implementation report (28-03-07) · wp3: evaluation of the project 10 3....

Documents