ANNEX 2.- Deliverable 2: 6th Month Management Meeting Minutes
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1 ANNEX 2.- Deliverable 2: 6th Month Management Meeting Minutes Project co-financed by:
2 PROGRAMME OF COMMUNITY ACTION IN THE FIELD OF PUBLIC HEALTH ( ) EUROPEAN INFORMATION SYSTEM TO MONITOR SHORT AND LONG- TERM MORBIDITY TO IMPROVE QUALITY OF CARE AND PATIENT- SAFETY FOR VERY LOW-BIRTH-WEIGHT INFANTS (EURONEOSTAT) PROPOSAL NO. A/ CONTRACT NO Meeting Minutes from the 6 th Month Management Meeting 23 rd May 2006, Prague (Czech Republic) Project co-financed by:
3 GENERAL DATA Acronym: Title of the Project: EuroNeoStat EUROPEAN INFORMATION SYSTEM TO MONITOR SHORT AND LONG-TERM MORBIDITY TO IMPROVE QUALITY OF CARE AND PATIENT-SAFETY FOR VERY LOW-BIRTH-WEIGHT INFANTS Contract No: Proposal No: A/ Place of meeting: Hotel Corinthia Panorama (Prague, Czech Republic) Date of meeting: 23 rd May 2006 Date of editing: 5 th June 2006 Circulation: Attendees and absentees Attendees: Hospital de Cruces Prof. Adolf Valls i Soler Dr. José Ignacio Pijoan Queen s University Belfast Prof. Henry Halliday Bambino Gesù Children s Hospital Dr. Carlo Corchia Dr. Marina Cuttini Uppsala University Children s Hospital Prof. Gunnar Sedin Ullevaal University Hospital Dr. Tom Arne Stiris Hospital 12 de Octubre Dr. Carmen Pallás Dr. Javier de la Cruz University of Liverpool Prof. Michael Weindling BIOEF Mr. Gorka Artola Absentees: Unfortunately the following delegates were not able to attend this meeting, presenting their apologies: Organisation Delegate Vote delegation Children s Hospital, University of Ulm Dr. Helmut Hummler To simple majority University of Lyon Prof. Olivier Claris To simple majority Isala Klinieken Dr. Harry Molendijk To simple majority University of Oulu Prof. Mikko Hallman Not delegated Azienda Ospedaliero-Universitaria Riuniti Umberto I, G. M. Lancisi, G. Salesi Dr. Virgilio Carnielli To simple majority 1
4 0) WELCOME AND PRESENTATIONS The Meeting started with Prof. Adolf Valls i Soler welcome attendees and presented a brief summary of the meeting agenda and objectives. After this introduction, Prof. Adolf Valls i Soler reviewed the main facts about EuroNeoStat project: mission, aims, work packages, work plan, estimated budget, and funding. At this point the main discussion was the status of the signature of the contract with the European Commission. Unfortunately the only information available about this matter at that moment was a reference given by Antoni Montserrat (Project officer) to Prof. Adolf Valls i Soler, estimating that the EC should sign the contract by mid June. Then, Prof. Adolf Valls i Soler reviewed the main additional conditions established previously by the EC for the execution of the project: Informed, signed parental consent (that finally will not be requested by the EC) Not to include items that might identify baby: - Maternal code - Birth, Admission & Discharge dates and hours - (to be substituted by time elapsed from birth) Use definitions of: - Eurocat (Congenital anomalies) - SCPE Group (Discapacities) - Peristat (Follow.up) Coordinate indicators (Dataset) with EuroPeriStat II Finally, Prof. Adolf Valls i Soler introduced the persons working at Bilbao Coordination Office, and the main actions executed by this team during the period and advancement in the design of the project logo. 2
5 1) REVIEW OF PREVIOUS MEETING MINUTES The following table shows actions agreed during the Kick-Off Meeting and actual status: ACTIONS Contact the EC in order to suppress the Signed parental consent from the project requirements. A delegate of EuroNeoStat will meet EuroPeriStat responsible group in order to establish coordination principles and actions WG1 Perinatal dataset and Benchmarking, shall work during this period with the actually designed Perinatal Dataset but shall develop an actualised proposal of Perinatal Dataset to be discussed and approved during the 2 nd Steering Meeting Leader and Members: Adolf and Mikko, Gunnar, Jose Ignacio, Tom, Carlo, Marina, Virgilio, Carmen Rosa, Javier. WG2 Follow up, shall develop a complete proposal of Follow-up Dataset for the 2007 Follow Up Pilot Phase in coordination with EuroPeriStat to be discussed and approved during the 2 nd Steering Meeting Leader and Members: Michael and Javier, Carmen Rosa, Gunnar, Jose Ignacio, Tom, Marina. Data form 2005 shall be used when possible to allow a Follow Up Pilot Phase beginning in 2007 WG3 EuroNeoSafe, shall develop a dataset and a detailed development proposal for the WP8 to be discussed and approved during the 2 nd Steering Meeting Leader and Members: Harry and Carmen Rosa, Tom, Carlo, Virgilio, Michael. AGENT DATE EXPECTED REAL COMMENTS NEW DATE BIOEF 02-feb-06 16/02/06 Accepted by the Commission 23/03/06 - Steering Chairman, Prof. Adolf Valls I Soler WG1 23-may-06 WG2 23-may-06 All associate partners WG3 23-may feb-06 06/02/06 Agreement to collaborate in the development of a minimum follow-up dataset Not completed due to delay in reception of funding, to be completed by e-discussion and approval at 3 rd Steering Meeting Not completed due to delay in reception of funding, to be completed by the 3 rd Steering Meeting In process 2007 Not completed due to delay in reception of funding, to be completed by the 3 rd Steering Meeting 3
6 7 Dissemination will prepare a complete proposal for: Project Dissemination Strategy and Plan. Publication rules and policy. o be discussed and approved during the 2 nd Steering Meeting Dissemin. 23-may Not completed due to delay in reception of funding, to be completed by the 3 rd Steering Meeting Leader and Members: Henry and Helmut and Adolf Dissemination will prepare Project brochures and publicity documentation will be developed for the promotion of participation NICUs not involved in the Associate or Collaborating Partner groups New NICUs shall be involved in the project as Collaborating Partners from January 2007 in advance. The Steering will develop a procedure for the inclusion of new partners during the 2 nd Steering Meeting WG4: Software: initial software tools will be submitted to all associate partners WG4: Software: Data harvesting systems shall be developed adapted to the characteristics of the individual databases of Associate Members WG4: Software: Shall include a link to EuroNeoStat Project EuroNeoNet Initiative website Dissemin. Steering 23-may may WG4 09-feb-2006 WG4 WG4 Feb-April Feb-April Not completed due to delay in reception of funding, to be completed by the 3 rd Steering Meeting Not completed due to delay in reception of funding, to be completed by the 3 rd Steering Meeting Initial tool developed but not circulated, distribution in the weeks following the meeting. Final software tools not developed due to lack of funding Initial data harvesting systems developed, further developments depending upon future development needs and delayed due to lack of funding 4 th quarter 06 OK - 4
7 2) TECHNICAL ISSUES Due to a non avoidable time delay, at this moment all attendees decided to approach the technical discussion instead of entering into the administrative and managerial issues. The following paragraphs summarise main contents, discussions and suggestions during this phase of the meeting. Working Group 1: Perinatal Dataset and Benchmarking Initially, Prof. Adolf Valls i Soler reviewed the status of Work Package 4, Perinatal Dataset, describing main objectives of this work package, main decisions taken during the Kick-Off phase and the situation of data collection among different Associate and Collaborating partners Following, Dr. José Ignacio Pijoán reviewed the status of Work Package 5, Standardised comparison of outcomes. This review focused the following matters: Methods and procedures under development for the assurance of data quality More accurate estimations of the expected number of babies that should be recruited during the study Samples and suggestions for the representation and graphing of the results derived from data analysis made over available historical data. After the presentations the group discussed these contents stressing the following issues: All associate partners will try to involve in the project as much NICUs and regional or national organisations collecting or centralising data about newborns in order to enhance the universe of data collection of the project. In order to ease the consecution of the previous objective the following actions were suggested: o Data to be collected should be quite similar to the data requested by Vermont- Oxford Network in order to avoid difficulties to involve NICUs that actually send data to this network. o EuroNeoStat should offer comparisons of results at NICU, regional or national level as a motivation to involve regional or national level organisations, provided that direct comparison between individual NICUs or wider level organisations will be only distributed with prior signed consent of involved parties. The potential identification of babies from the data transferred to EuroNeoStat project could be a potential barrier for the incorporation of further NICUs or organisations, therefore a formal signed statement guaranteeing the privacy of recruited babies should be prepared for distribution if necessary. The required privacy of data could cause difficulties in the tracking of those babies being transferred between hospitals. These babies could be introduced from each hospital involved in the transference, generating two or more data entries in the database and an 5
8 error in any analysis involving this data. This potential problem should be solved before entering in a broader data collection. Finally, the consortium agreed to work in the modification of the Perinatal Dataset for discussion and approval of definitive dataset during 3 rd Steering. For this purpose the BCO (Bilbao Coordination Office) will distribute again a table in electronic format with this dataset for easy modification. Working Group 2: Minimal follow-up dataset At this part of the meeting Prof. Michael Weindling and Prof. Adolf Valls i Soler, reviewed the activities involved within this working group, basically related to Work Package 6, Minimal follow-up dataset. Main treated issues were: Data to be included in the data set. The possibility to develop minimal and expanded data sets for their use depending in the potential possibilities of each individual NICU to perform follow-up actions. Criteria for the selection of NICUs that will perform the Follow-up Coordination with EuroPeriStat. Main subjects of the discussion after these initial interventions were: A short term representation of EuroNeoStat project within EuroPeriStat project will be possible due to the participation of Dr. Javier de la Cruz and Dr. Marina Cuttini in the next meeting of EuroPeriStat in Porto. Both agreed to act as deputies of EuroNeoStat Steering and to feedback the other members, especially Prof. Michael Weindling, about those matters that could be of the interest for EuroNeoStat project. Standard language used for the development of the project and the execution of the Follow-Up action shall be English. Anyway, local organisation could translate templates, procedures or whatever they need for adequate execution of specific tasks, regarded that information is transferred to the BCO exclusively in English. This principle is applicable also for other Woking Groups. Working Group 3: Patient Safety At this part of the meeting Prof. Adolf Valls i Soler, reviewed the activities involved within this working group, basically related to Work Package 8, EuroNeoSafe. Main treated issues were: Design of Voluntary Reporting System Quasi-incidents Design of dataset and definitions Due to the absence of Dr. Harry Molendjik, main responsible of this Working Group, the group decided to postpone discussions and decision about this Work Package to the 3 rd Steering Meeting. 6
9 3) OTHER ISSUES Working Group 4: Software At this part of the meeting Prof. Adolf Valls i Soler reviewed advancements achieved in this working group, responsible for the Work Package 9, Software and Website. Main presented results were: Paper form system. Samples and Screen Prints of developed software. Future data entry systems: Web based direct data entry, patches for Commercial/Freeware Software packages (Badger system, NeoSoft, Neolink 2000, SEN- 1500, ) Dissemination At this stage, Prof. Adolf Valls i Soler and Prof. Henry Halliday reviewed main dissemination related topics: Initial suggestions to be considered in order to prepare a draft Dissemination Plan (articles, presentations in meetings). Publication and Dissemination Strategies. Potential type of studies derived from the project. Responsibilities of the Dissemination Sustainability At the end of this part of the meeting Prof. Adolf Valls i Soler, reviewed potential future evolution paths for the project sustainability such as: 1. EuroNeoStat II 2. 7 th Framework Programme. 3. Nested, cluster studies. 4. Local or regional funding grants. 5. Relationship to EuroNeoNet 4) ADMINISTRATIVE ISSUES After the technical session, Mr. Gorka Artola reviewed the following issues related to the administrative management of the project: Legal and contractual aspects derived from the contract to be signed with the European Commission: Financial aspects of the project: Auditing and minimal reporting needs for the European Commission: Project resources: Basic administrative and financial procedures. 7
10 Finally, Mr Artola summarised costs assumed up to now by BIOEF and a detailed description of the administrative procedures that this organisation is following and will follow once the contract is signed were presented in order to help clarifying doubt arose during the period through a practical sample. 5) MANAGEMENT ISSUES In order to finalise the meeting Mr Gorka Artola reviewed the agreed management structure, procedures and policies and confirmed that all decisions and resolutions taken during the meeting were valid because all quorum conditions were satisfied during the whole meeting with the attendees and vote delegations. Furthermore agreed communication and information exchange standards were reviewed. TYPE OF INFORMATION Word processors STANDARD SOFTWARE Microsoft Word 2000 Graphics and table calculation Microsoft Excel 2000 Packing/printing software Presentations WinZip 8.0 Adobe acrobat Microsoft PowerPoint 2000 Finally, Mr Gorka Artola explained the Deliverable completion based evaluation method suggested for the project and presented the list of expected deliverables, delivery dates and responsible groups. At this stage of the project all project deliverables expected have already been developed but anyway the Project Coordinator will be continuously informing about due dates for the preparation of these documents to each responsible group. 8
11 6) ACTIONS FOR NEXT PERIOD Plans for the next period were defined as follows: ACTIONS 1 Initial Dataset will be forward to Associate Partners with suggestions to develop be later discussed by the WG1. The WG1 Perinatal dataset and Benchmarking shall work during this period with the 2005 Perinatal Dataset to 2 develop an actualised proposal of the 2007 Perinatal Dataset to be approved at the 3 rd Steering Meeting WG2 Follow up, shall develop a complete proposal of 3 Follow-up Dataset for the 2007 Follow Up Pilot Phase in coordination with EuroPeriStat to be discussed and approved during the 3 rd Steering Meeting 4 Data form 2005 shall be used when possible to allow a Follow Up Pilot Phase beginning in 2007 WG3 EuroNeoSafe, shall develop a dataset and a detailed 5 development proposal for the WP8 to be discussed and approved during the 3 rd Steering Meeting Dissemination will prepare a complete proposal for: 6 Project Dissemination Strategy and Plan. Publication rules and policy. o be discussed and approved during the 3 rd Steering Meeting Dissemination will prepare Project brochures 7 and publicity documentation will be developed for the promotion of participation NICUs not involved in the Associate or Collaborating Partner groups New NICUs shall be involved in the project as Collaborating Partners from January 2007 in advance. 8 The Steering will develop a procedure for the inclusion of new partners during the 3 rd Steering Meeting 9 WG4: Software: initial software tools will be submitted to all associate partners WG4: Software: Data harvesting systems shall be 10 developed adapted to the characteristics of the individual databases of Associate Members Dr. Marina Cuttini and Dr. Javier de la Cruz will represent the EuroNeoStat project in the next meeting of EuroPeriStat in Porto with the further objective to 11 feedback the other associate partners, specially Prof. Henry Halliday, about those matters that could be of the interest for EuroNeoStat. AGENT DATE EXPECTED REAL BCO Jun-Jul 06 WG1 WG2 All associate partners WG3 Dissemination Dissemination Steering 2007 WG4 Jun-Jul 06 WG4 Dr. Marina Cuttini and Dr. Javier de la Cruz 4 th quarter 06 7) NEXT MEETING Finally the Consortium decided to establish the date for the next Steering Meeting, that will take place in Barcelona (Spain) on 11 th October 2006, taking advantage of ESPR/EuroPaediatrics 2006 meeting on 7 th -10 th October in this city. 9
12 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.
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