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European Cornea and Cell Transplantation Registry [ECCTR] [709723] - Project
Coordination of the project by lead ESCRS

Start month:1 - End month: 36

Description of work
ESCRS will be responsible for coordinating and managing the technical and financial aspects and the day-to-day running of the project.
The Lead of this WP will oversee:
o the f...
Description of work
ESCRS will be responsible for coordinating and managing the technical and financial aspects and the day-to-day running of the project.
The Lead of this WP will oversee:
o the financial administration and the reporting to the European Commission;
o ensure adequate synchronization of the work packages and associated methodologies, and smooth communication among work packages;
o Communicate project findings to relevant stakeholders, policy makers and the European Commission.

This work package is divided in five tasks:

Task 1.1. Project Start-up
- The Leader of this WP will organise the kick off meeting in Luxemboug. The coordinator and all partners will call for participation the representatives of CHAFEA/SANTE.
- The Agenda of the kick-off meeting will be agreed between the partners and with CHAFEA/SANTE. During the meeting the partners will discuss and commit to the project overview: project objectives, work packages, activities, reporting and financial aspects.

Task 1.2. Legal and administrative management
- The Coordinator will prepare a Consortium Agreement that will govern the consortium activities and resolution of conflicts between partners
- The Coordinator will facilitate the setting up of the ECCTR Steering Committee formed by one or two members of ESCRS, EuCornea, EEBA, and National Quality Registries member and Prof. Mats Lundstrom.
- The Coordinator will keep-up-to date the CHAFEA and the Consortium and deal with all other legal issues during the project.
- The Coordinator will be responsible for adequate document management during and after the project, also covering the official reporting to the Commission, including periodic Reporting, submission of the deliverables and all issues that need to be communicated or discussed with the Commission
- The Coordinator will be responsible for the management of the sub-contracting costs
- The coordinator will be responsible for the procurement procedures and management of sub-contracting costs

Task 1.3 Financial management
The project’s financial management will be the responsibility of ESCRS. As such, it is not only responsible for generating accurate financial interim reports regarding the project’s resources and expenditures, it also monitors whether funds are used for their intended purposes, in an efficient and cost-effective way.
For financial monitoring we will make use of tools and instruments used for the execution of other projects. Our computerized accounting system will be used for recording, processing and reporting on the project’s transactions, and regular budget reports and interim internal financial reports will be used for project budget monitoring.
The Financial Director of ESCRS will be responsible for the financial control and reporting for the project. All expenditure will follow the reimbursement policies of each associated partner and funds will be released on the presentation of suitable receipts for vouched expenses.
Disbursements will be tracked on SAGE online accounting system. Annual audits will be executed in accordance with EU requirements.

Task 1.4 Coordination of Steering Committee
- The project coordinator will oversee the process of the Steering Committee, will organise Steering Committee meetings, disseminate regularly updates about project milestones and activities
- The coordinator will organise follow-ups and report on progress through conference call, e-mails and reports.
- Prof Mats Lundstrom and Dr Mor Dickman will oversee and guide the IT provider for the development of the ECCTR and ensuring the quality of the clinical part of the system.
- Members of the Committee will be responsible for checking and validating the medical part of the ECCTR in relation to: datasets and development of outcome reports from the registry.

Task 1.5 Project management, follow-up, assessment and adjustments
The project progress will be measured against the Gantt Chart, deliverables, milestones and
Dissemination of the project results by lead EuCornea

Start month:3 - End month: 36

ESCRS, EuCornea and EEBA sit at the hub of an authoritative dissemination network and offer a unique forum for discussion and learning which ensures that international expertise is shared by ophthalmo...
ESCRS, EuCornea and EEBA sit at the hub of an authoritative dissemination network and offer a unique forum for discussion and learning which ensures that international expertise is shared by ophthalmologists all over Europe. This is accomplished by organising annual international conferences, developing educations programmes and tools for ophthalmologists, maintaining Society news and educational websites, publishing ophthalmic news magazines and peer reviewed scientific journals.
All partners are involved and will be committed to:
- Promote the philosophy of quality Registries and the Europe-wide network and importance of the registry aiming to report a unique overview of information, concerning Corneal Transplantation across Europe
- Disseminate the project activities at International level

This work package is divided in six tasks as follow:
Task 2.1 Design promotional materials for the project
- Development of project brand: logo, ppt template, design templates
- Design and Development of project brochure
- Development and design of ECCTR website
All printed materials and communications will acknowledge the European Union visibility and funding. The logos of the European Commission and CHAFEA Agency will be in all publications.
Task 2.2 ECCTR Launch amongst ophthalmologists in Europe
- The Annual Congresses are the most prominent and central activity of the Societies and attracts annually over 8,000 ophthalmic surgeons.
- It is intended to launch the ECCTR project at the XXXIV Congress of the ESCRS and EuCornea, 10-14 September 2016. Bella Center, Copenhagen, Denmark.
- The aim of the launch is to create awareness of the project and invite a large number of stakeholders that could contribute to make the programme successful during its implementation at European and international level.
- The ESCRS President will present the ECCTR project during the ESCRS Opening Ceremony; visibility of EU funds for this project will be highlighted.

Task 2.3 Dissemination Plan
- Agreement on dissemination plan, including a stakeholders analysis, the different tools and channels (see also listed under tasks 2.1, 2.2, 2.3, 2.5, WP5 communication plan and respective deliverables), anticipated project results and indicators. The plan will clearly state how the target groups can be reached. The dissemination plan will be approved by the Steering Committee and shared between all project partners. The approved dissemination plan will be shared with the EC.

Task 2.4 Promotion of the ECCTR project during medical congresses
All Partners will cooperate in organising and including podium presentations during the sessions of the scientific programmes of the ESCRS, EEBA and EuCornea Congresses. The visibility of EU co-financing in accordance with the EU guidelines will be ensured.

The promotion at the following congresses will offer a unique forum to the ECCTR project for discussion, exchange of best practices and visibility of the findings shared by ophthalmologists all over Europe at the following congresses:
- XXXIV Congress of the ESCRS and EuCornea,
10-14 September 2016. Bella Center, Copenhagen, Denmark
- XXXV Congress of the ESCRS, Lisbon, 7-11 October 2017.
FIL – International Fair of Lisbon, Lisbon, Portugal
- XXXVI Congress of the ESCR and EUCornea,
22-26 September 2018. Reed Messe, Vienna, Austria
- EEBA Annual meeting for 2017 and 2018
- Annual National Registry Meetings

Task 2.5 Organisation of instructional course for doctors during the medical Congresses
It is planned to organise a ECCTR instructional course at the medical congresses of the ESCRS and EUCornea in Lisbon and Vienna where doctors and nurses could participate and learn about the use of the ECCTR system.
The course will be prepared by Prof. Mats Lundstrom and Dr Mor Dickman.
The course content will address: ECCTR purpose, background and design, presentation of the ECCTR system, tools for clinical improvement, output from the ECCTR system for ben
Monitoring and Evaluation by lead ESCRS

Start month:1 - End month: 36

A plan will be put in place to establish the guidelines for evaluation in order to verify that the project is being implemented as planned.

Monitoring the project activities and results and measurin...
A plan will be put in place to establish the guidelines for evaluation in order to verify that the project is being implemented as planned.

Monitoring the project activities and results and measuring how these contribute to achieving the specific objectives will be a continuous effort throughout the project. Project staff will prepare and collect all documents and information that is relevant in the process of monitoring the project process, such as reports, minutes of the meeting, periodically exchange of information thought e-mails and teleconferences.
In order to verify if and to what extend the results of the activities contribute to achieving the specific objectives, the key indicators listed under each of the specific objectives must be closely monitored and evaluated. During the inception phase the project management team will prepare an evaluation plan with key evaluation questions related to a) the establishment of the EU web-based registry b) impact of the EU registry with regard to scares donor tissue to the benefits of patients and society c) how the EU registry allows health professionals and local authorities to asses and verify the safety quality and efficacy of transplantations, the key questions will take in considerations the process indicator related to each objective and workpackages.
- A clear role and task division will be agreed upon and the most appropriate project partner will be made responsible. At the first Steering Committee meeting the evaluation plan will be shared amongst all partners. The plan will also form an annex to the consortium agreement. Before each Steering Committee meeting, and at least every quarter, the responsible partner reports on progress and results per envisaged activity, and the targets related to the process and output indicators to check if the envisaged results are on track.
It is the responsibility of ESCRS to overall monitor progress on activities, and how these contribute to achieving the specific objectives. In the final year of the project emphasis will be put on monitoring progress on the outcome/impact indicators to ensure that the targets are being met and the impact on the target groups is according to the agreed plan.
The Steering Committee meets every twice a year to monitor progress and to take action and decide on measures if required. All project activities, and how these contribute to achieving the specific objectives and overall goal of the project, will be extensively evaluated and the results achieved, the lessons learnt and best practices will be transferred to the academics, health professionals and authorities. Results on project achievements will be shared among stakeholders across Europe.

Development of the software for the EU web-based registry by lead ESCRS

Start month:1 - End month: 36

ESCRS with Associated Partners will meet and agree the final dataset and reporting function for the IT infrastructure of the registry.
ESCRS and ECCTR Steering Committee will lead the discussion with...
ESCRS with Associated Partners will meet and agree the final dataset and reporting function for the IT infrastructure of the registry.
ESCRS and ECCTR Steering Committee will lead the discussion with the IT provider for the development of the software in order to accomplish the technical roll out of the system across Europe.
The following tasks will be carried out during this work package:
Task 4.1 Review and Evaluation of data set for the system
Prof Mats Lundstrom will lead the discussion with the Steering Committee for the finalisation of the database guidelines for the system. For this purpose, the Partners will need to agree on:
- Review and evaluate the clinical data set for the system
- The description of parameters and dataset for the system
- Parameters for the Patient Report Outcomes
- The reporting outcomes of the registry.
Once all Partners have agreed, Prof Mats Lundstrom will prepare the Coding guidelines document for the system. The document will contain data set dictionary, value sets data management and coding guidelines for the purpose of building the EU registry.

Task 4.2 Developing of the system
The It provider will develop the system under the Database guidelines received by Prof. Mats Lundstrom. The It provider will be in charge of:
- Design and the develop the entire database
- Development of the Patient Outcome Questionnaire
- Development of user guide and paper forms

Task 4.3 Testing of the system
The testing phase is very important before rolling out the system, the following tasks will be carried out:
- The It provider and a selected group of people will be involved in the testing phase of the system
- The system should be tested on the response time of different areas such as: different types of input devices and Network, (i.e. Laptop, Personal Computer, iPad, and other Tabs)
- Test on different Operating systems and networks, loading volume and security
- Each module will be checked separately and make sure that everything will reflect the desire output

Task 4.4 Development of interfaces with Existing Registries across Europe
Prof Mats Lundstrom and Dr Mor Dickman will take care of the finalisation of the interfaces documentation and make sure that the ECCTR will includes all parameters in connection with the implementation of tasks of WP5.

- They will carry out the quality control of clinical compatibility amongst the existing European Registries and the ECCTR database
- Evaluation and validation of the systems
- The IT provider will develop the user interface document
- The IT provider and the staff of the European registries will cooperate for interfacing the systems and guarantee the direct transfer of surgeries to the ECCTR.

Task 4.5 The system goes live
- ESCRS and all partners will promote the roll-out of the ECCTR database and inform all members of participating Society (ESCRS, EEBA, EuCornea) in relation to the availability of the system.

Task 5.5 Finalisation of EU web-based registry
The Clinical director and Steering Committee members will make sure that all inputs and exchange of knowledge discussed during all meetings outlined in the Progress Reports concerning corneal graft failure and adverse (immune) reactions agreed during the implementation of WP5 will be included in the ECCTR.

Active clinical cooperation and networking with VISICORT by lead MU

Start month:1 - End month: 36

Dr Mor Dickman will be responsible for the development of a communication plan between the different stakeholders of ECCTR and the researchers involved in the actual EU-funded projects.

This work pa...
Dr Mor Dickman will be responsible for the development of a communication plan between the different stakeholders of ECCTR and the researchers involved in the actual EU-funded projects.

This work package it is fundamental to guarantee the synchronisation, exchange of knowledge and good practice about new clinical findings related to failure of corneal transplants and adverse (immune) reactions.
Prof. Jesper Hjortdal, as one of the members of the Steering Committee of ECCTR, also, actively involved in FP7‐HEALTH‐2013 VISICORT will guarantee the efficiency of the exchange of scientific findings to be considered for:

- Establishment and validations of parameters to be included in the system related to failure of corneal transplants and adverse (immune) reactions.
- During the final phase of the project, data collected from the system will be analysed by the Steering Committee with a view to beginning dissemination of information and initiation of recommendations for clinical variables related to quality, efficacy and safety of corneal transplantations.

Prof Rudy Nuijts and Dr Mor Dickman will be responsible for finalising the decision about data sets and value sets to be included in the EU wide Platform and co-operate on the exchange of information with Prof. Jesper Hjortdal.

Dr Mor Dickman will keep active communication with Prof. Lundstrom and Steering Committee for including any updates on new findings and make sure that any new parameters will be included in the system and guarantee the correlation within WP4, WP5 and WP6.
The clinical findings will be included in the deliverable : Final report Guidelines reccomandations

Moreover, Prof. Nuijts, Prof. Hjortdal and Dr Dickman will be responsible for the development of a recommendations report on quality, efficacy and safety of corneal transplantations to be disseminated by the end of the project.

This work package will also guarantee the exchange of information with European joint action VISTART (Vigilance and Inspection for the Safety of Transfusion, Assisted Reproduction and Transplantation).

The progress report and recommendations reports deliverables of this WP will take into account: corneal graft failure, adverse (immune) events following corneal transplantation, risk factors and treatment(s) used against rejection.
Data collection, recruitment of clinics across Europe by lead FBOV

Start month:12 - End month: 36

ESCRS and FBVO/EEBA will be working together for the recruitment of the clinics and eye banks across Europe.
All associated partners; the existing European Registries will participate in the collecti...
ESCRS and FBVO/EEBA will be working together for the recruitment of the clinics and eye banks across Europe.
All associated partners; the existing European Registries will participate in the collection of data
The following tasks will be carried out during this work package:
Task 6.1 Recruitment of clinics
- EEBA receives data from 84 eye banks members coming from 24 European countries.
- EEBA and ESCRS will work together for recruiting the major number of clinics and Eye Banks willing to participate in the collection of data for the ECCTR project

Task 6.2 Training of personnel involved in the data collections
- The IT provider will prepare an online demo on the use of the ECCTR and will be available for all personnel involved in the project.

Task 6.3 Development of |Interfaces within the 3 existing EU Registries
- The already existing Registries will share information related to: data sets and coding lines of the system
- Prof. Mats Lundstrom and Dr Dickman will map and evaluate the data available of the 3 systems
- Prof. Mats Lundstrom and Dr Dickman will develop the Clinical compatibility for each Registry and circulate the document amongst the members of the Executive Committee
- The Executive Committee will agree on the compulsory dataset of the Registry and agreed on the choice of eventually transferring historical data to the Registry.
- The IT provider will develop the web service based interfaces
- The European Registry will have interfaces to the existing Registries and ensure direct transfer of data
- Prof Mats Lundstrom and Dr Dickman will ensure that all information will be included in ECCTR and guarantee the relationship of the tasks implemented during WP4 and WP5

Task 6.4 Start of data collection for clinics and universities
- The ECCTR project team will monitor the progress of collection of data in the system (direct transfer and manual input)
- The project staff will be available by phone or e-mail for any information and support needed to guarantee a successful roll out of the system.

Evaluation of data collected and development of an evidence based European protocol by lead NTS

Start month:24 - End month: 36

The Steering Committee will meet regularly and discuss on the progress for the development of the registry, validation process and review of the data collected.

Validation process: The database soft...
The Steering Committee will meet regularly and discuss on the progress for the development of the registry, validation process and review of the data collected.

Validation process: The database software should have built-in validation functions that include possible limits for all values. The system should also have cross-analysis functions that sort out impossible combinations of data. All dates will also have a validation function so preoperative dates must precede surgery dates and surgery dates must precede follow up dates.
On a regular basis data from each source database should be validated towards the European database. This means regular checks about number of reported cases, type of surgeries, donor corneas and follow up visits. The aim is also to check that detailed data for a case in source databases corresponds to data in the European database. This validation process will not take place on a regular basis but on single occasions when need is indicated by the analysed data
The Steering Committee will meet regularly and discuss on the progress and review of the data collected.

The Steering Committee will analyse and make recommendations for the following:
-Analyse corneal transplant outcomes: Graft survival, Visual acuity, Endothelial cell density, Refractive astigmatism, Topographic astigmatism
- Analyse corneal transplant safety: Donor tissue loss, Primary graft failure, Graft rejection, Secondary glaucoma, Infection of the graft, Recurrence of original disease, Cataract
-Analyse the number and type of corneal transplantations performed in each country and measure where the grafts are coming from (national eye bank, EU eye bank, third country eye bank)
-Evaluate 2 years outcomes stratified by reason for grafting:
1) improve vision 2) relieve pain 3) Preserve eye

Prof Mats Lundstrom and Dr Mor Dickman will support the Leader of this WP, as well as all members of the Steering Committee will participate on analysing the data collected in the Registry.

The data analysed in the Registry will concern: content Donor and recipient demographics, Donor preservation and processing, annual number of corneal transplantations per transplantation technique and country, indications for corneal transplantation per transplantation technique and country, Core outcomes and safety data per transplantation technique and country)

Prof Mats Lundstrom and Dr Mor Dickman and all members of the Steering Committee will support the Leader of this WP for the development of the guidelines recommendations.

The final report guidelines will include data on: preoperative and intraoperative data, preoperative Examination (Visual Acuity, Refraction), ocular comorbidity, difficult surgery, type of anesthesia, surgical complications, Follow –up data: visual outcomes, refractive outcomes, post-operative complications.

The Final Report Guidelines recommendations will be directed to ophthalmologists and European organisations involved in corneal transplantations and competent local Authorities.

The Coordinator will call for participation and support of CHAFEA for the dissemination and visibility of the Final Report Guidelines at EU level and targeting relevant stakeholders.

Details