study protocol - europa · av. de sarrià 137, entr. 4a 08017 barcelona - spain phone: +34 93 252...

Study Protocol

1

STUDY PROTOCOL

ET

ODEQUS Kick-off Meeting Leuven, 3-5 November 2010

�

http://www.vlada.cg.yu/img/1059481673.gif

http://www.vlada.cg.yu/img/1059481673.gif

Study Protocol

2

Table of contents

Welcome letter

1. Project summary ................................................................................... 4

2. Project coordination .............................................................................. 7

2.1 Partners and donation experts ............................................ 8

2.2 Meetings ............................................................................ 12

2.3 Trainings ............................................................................ 13

2.4 Communication tools .......................................................... 14

3. Project development ............................................................................. 17

3.1 Scientific Working Groups .................................................. 18

3.2 Working Packages ............................................................. 20

3.3 Timetable specification ....................................................... 33

3.4 Timetable specification ....................................................... 33

Acronyms List

Study Protocol

3

Dear friends,

I welcome you to the First Working Meeting of the Organ Donation European Quality System –

ODEQUS Project.

This project is a great opportunity to meet each other and discuss all those common issues which

we have been working in for a long time.

We all know that part of the success in our work depends on the quality of the donation

processes.

I hope that we will work together for the improvement of the daily activity of the European

donation services. But more than this, I wish this project make us grow stronger.

Sincerely,

Dr. Martí Manyalich

Study Protocol

4

1. Project summary

Study Protocol

5

The ODEQUS project aims to create useful tools, applicable to all European countries, to increase the

efficiency in the donation process. Such tools, based on the analysis of the best practices in organ

donation and included in a Quality System, should help to increase the number of citizens attended by

the European donation programs, despite the economic, legal or cultural differences.

ODEQUS consortium is formed by 12 associated partners. The project also counts with the

participation of 5 collaborating partners.

The main objective of the project is to determine standards of best practices and to develop quality indicators for Donation after Brain Death (DBD), Donation after Cardiac Death (DCD) and Living Donation (LD) in order to create tools to evaluate the overall quality in organ donation.

More specifically, the objectives of the Project are:

To identify and develop Quality Criteria (QC) in 3 types of organ donation (DBD, DCD and LD) focused mainly at hospital level.

To create Quality Indicators (QI) in order to evaluate organizational structures, clinical procedures and outcomes on the 3 types of organ donation.

To develop Auditing tools in order to evaluate the implementation of the best

practices described in the QC and the use of QI.

To train healthcare professionals in the use of QI, checklists and auditing procedures.

Methods and means

The standards of best practices will be identified according to:

Expert’s opinion

Literature review and research for evidence, whenever possible

Survey sent to all European countries to know about the current use of QI at hospital level

The main fields to be considered for evaluating the organizational structures will be: legal framework, accreditation and certification, organization, human and material resources, education and research.

Concerning the clinical procedures, the main fields to be considered will be: donor identification, clinical evaluation, death diagnosis, family/personal consent, donor maintenance, organ viability, surgical recovery and preservation, number of donors/organs/transplants.

Two types of training will be designed:

Creation of QC and QI

Use of the evaluation tools derived from the QC and QI. External evaluations will be conducted in selected hospitals.

Study Protocol

6

Strategic relevance

With the aim of representing the European countries’ diversity, the following criteria have been considered for the selection of partners:

Expertise on some type of donation

Experience in previous collaborative European projects such as Alliance-O, ETPOD, DOPKI, EQSTB, EULID

Diverse efficiency of the donation programs in their countries

Geographical and social situation

The tools to be created should be wide enough to be implemented in different target hospitals and may be later exported to other European Countries.

Study Protocol

7

2. Project coordination

Study Protocol

8

2.1. Partners and Donation Experts

Promoter: Martí Manyalich - Facultat de Medicina - Universitat de Barcelona (UB)

Country Partner Institution Donation Expert

Austria Ferdinand Mühlbacher

Medical University of Vienna Georg Györi

Croatia Mirela Busic Ministry of Health and Social Welfare Zeljka Gavranović

France Marie Thuong Agence de la Biomédecine Julien Charpentier

Germany Günter Kirste Deutsche Stiftung Organtransplantation Werner Lauchart

Italy Francesco Procaccio Verona University City Hospital / FITOT Francesco Procaccio

Portugal Maria João Aguiar Autoridade para os Serviços de Sangue e Transplantação

Rui Maio

Poland Januz Walazewski Poltransplant Jarosław Czerwiński

Romania Victor Zota Fundatia pentru Transplant Romania Rosana Turcu

Spain Maria Paula Gómez Donation and Transplantation Institute Maria Paula Gómez

Spain José Luis Escalante SERMAS / Fundación Hospital Gregorio Marañón

José Luis Escalante

Sweden Bo-Göran Ericzon Karolinska Institute Öystein Jynge

United Kingdom

Sue Falvey NHS Blood and Transplant Sue Falvey

Study Protocol

9

Promoter: Manyalich, Martí

Director Transplant Procurement Management

Parc Científic de Barcelona

Baldiri Reixac, 4-8

Torres R+D+I

08018 Barcelona – Spain

Phone: + 34 93 403 76 87

E-mail: [email protected] Associated Partners: Aguiar, Maria João

Autoridade para Serviços de Sangue e da

Transplantação

Av João Crisóstomo, nº 9, 1º andar 1049-062 Lisboa – Portugal Phone: +35 121 3305000 E-mail: [email protected] Busic, Mirela Ministry of Health and Social Welfare Republic of Croatia

Ksaver, 200 A

10 000 Zagreb - Croatia

Phone: + 385 1 460 7538

E-mail: [email protected]

Ericzon, Bo-Goran

CLINTEC, Karolinska Institutet - Karolinska

University Hospital Huddinge, F82

S-141 86 Stockholm -Sweden

Phone: +46 8 585 876 66


Escalante, José Luis

Fundación para la Investigación Biomédica del

Hospital Gregorio Marañón

Pabellón de Gobierno. Planta baja.

Doctor Esquerdo, 46

28007 Madrid - Spain

Phone: +34 91 5867174

E-mail: [email protected] Falvey, Sue

NHS Blood and Transplant – Directorate of

Organ Donation and Transplantation

Fox Den Road, Stoke Gifford

BS34 8RR Bristol - United Kingdom

Phone: +44 117 975 3 7517


Gómez, María Paula

Av. de Sarrià 137, entr. 4a

08017 Barcelona - Spain

Phone: +34 93 403 19 03

E-mail: [email protected] Kirste, Guenter Deutsche Stiftung Organstransplantation – DSO Emil von Behring-Passage 63263 Neu-Isenburg – Germany Phone: +49 0 6102 3008 157 E-mail: [email protected] Mühlbacher, Ferdinand Medizinische Universitaet Wien

Spitalgasse, 23

1090 Wien - Austria

Phone: +43 1 40400 6896

E-mail: [email protected]; Procaccio, Francesco

Verona University City Hospital

Passaggio Luigi Gaudenzio 1

35030 Padova - Italy

Phone: + 39 049 8763392

E-mail: [email protected] Thuong, Marie

Agence de Biomédecine

1 Avenue du Stade de France

93212 Saint-Denis La Plaine Cedex - France

Phone: +33 1 55 93 65 26

E-mail: [email protected] Walazewski, Janusz

Polish Transplant Coordinating Centre -

Poltransplant

al. Jerozolimskie 87

02-001 Warsaw - Poland

Phone: +48 226225806

E-mail: [email protected] Zota, Victor

Fundatia Pentru Transplant

Str. Constantin Caracas, Nr. 2-8, Et. 3, Sector 1

011155 Bucharest – Romania

Phone: +40 724 392 093 E-mail: [email protected]

mailto:[email protected]












Study Protocol

10

Donation Experts:

Charpentier, Julien

Groupe Hospitalier Cochin

27, Rue du Faubourg Saint Jacques

75679 Paris Cedex - France

Phone: +01 58 41 25 23

E-mail: [email protected] Czerwiński, Jarosław Poltransplant al. Jerozolimskie 87 02-001 Warsaw - Poland Phone: +48 22 601 33 04 71 E-mail: [email protected] Escalante, José Luis Hospital General Universitario Gregorio Marañon C/ Dr Esquerdo 46, Pabellon de Gobierno, 3ª Pl 28007 Madrid - Spain Phone: +34 91 586 71 74 E-mail: [email protected] Falvey, Sue NHS Blood and Transplant Fox Den Road, Stoke Gifford BS34 8RR Bristol - United Kingdom Phone: +44 11 79 75 74 74 E-mail: [email protected] Gavranović, Zeljka Clinical Hospital Sestre Milosrdnice Vinogradska 29. 10000 Zagreb - Croatia Phone: +38 5993787275 E-mail: [email protected] Gómez, María Paula

DTI Foundation

Av. de Sarrià 137, entr. 4a


Phone: +34 93 252 1374 E-mail: [email protected] Guasch, Xavier TPM

Ciutat de Granada, 131


Phone: +34 93 403 76 87 E-mail: [email protected] Györi, Georg

Medical University of Vienna

Spitalgasse, 23

1090 Wien - Austria

Phone: +431 40400 6739


Jynge, Öystein

Karolinska University Hospital

Huddinge, F82

S-141 86 Stockholm – Sweden

Phone: +46 8 585 825 48

E-mail: [email protected] Lauchart, Werner Deutsche Stiftung Organtrasplantation Kriegerstraße 6 70191 Stuttgart - Germany Phone: +49 69 677 328 5000 E-mail: [email protected] Maio, Rui Hospital Universitário de Santa Maria Avenida Professor Egas Moniz 1600 Lisbon - Portugal E-mail: [email protected] Procaccio, Francesco Fondazione per l’Incremento dei Trapianti d’Organo e Tessuti

Passaggio Luigi Gaudenzio 1

35030 Padova - Italy Phone: + 39 049 8763392 E-mail: [email protected] Turcu, Rosana Fundatia pentru Transplant

Str. Constantin Caracas, Nr. 2-8, Et. 3, Sector 1

011155 Bucharest - Romania

Phone: +40 722 384 683














Study Protocol

11

Collaborating Partners: Abela, Carmel Joseph Mater Dei Hospital c/o 15, Alfred Camilleri Street Attard ATD 1922 - Malta Phone: +356 2545 7234 E-mail: [email protected] Avsec, Danica Slovenija Transplant SI-1000 Ljubljana, Zaloška 7 - Slovenia Phone: + 386 1 300 6860 E-mail: [email protected] Chatzixiros, Stratos Hellenic Transplant Organisation 5 Anastasiou Tsoha str. Athens 11521 - Greece Phone: +30 210 6471200 E-mail: [email protected] Sandor, Mihaly Hungarian National Blood Transfusion Sevice H-1113 Budapest, Karolina út 19-21 - Hungary Phone: +3613914574 E-mail: [email protected]

Yücetin, Levent Antalya Medicalpark Hastanesi Fener Mah. Tekelioğlu Cad. No:7 Lara Antalya - Turkey Phone: + 90 242 314 33 02 E-mail: [email protected]






Study Protocol

12

2.2 Meetings

Three meetings have been planned to be held during the ODEQUS Project development. They

will last 2 days/2 nights, and will follow a similar schedule structure.

The associated partners will designate a donation expert in each country to be present at the

meetings and trainings and to develop the project activities.

First Working Meeting

3-5 November 2010, Leuven (Belgium)

Objectives:

To introduce the Coordinator and partners organisations as soon as the project aims

and activities to be developed.

To introduce the design of Quality Criteria and Quality Indicators.

To define the Working Groups structure, objectives and deadlines during the project first year.

To explain the budget management and administrative control systems.

Intermediate Working Meeting

October 2011, Barcelona (Spain)

Objectives:

To review the results obtained during the first year.

To reach a consensus in Quality Indicators.

To determine the Working Groups objectives and deadlines during the project second year.

To clarify the budget management.

Final Meeting

June 2013, Barcelona (Spain)

Objectives:

To review all the activities developed during the project.

To discuss the results of the hospital evaluations.

To approve the draft of the Project Final Report.

Study Protocol

13

2.3 Trainings

Two types of training have been designed:

Training in QC Consensus and QI Development

4-5 April 2011, Lisbon (Portugal)

Objectives:

Reach a consensus in the Quality Criteria developed by each Working Group.

Train the donation experts in how to the design Quality Indicators.

Introduce the methodology of applying the Quality Indicators in the selected hospitals.

Present the results of the Survey in Quality in Donation Process.

Training in Auditing

March 2012, Lisbon (Portugal)

Objectives:

Train the donation experts in how to use the evaluation tools and the Quality System in their hospitals.

Define the development of external evaluations in the selected hospitals.

Study Protocol

14

2.4 Communication tools Public website

The ODEQUS Project has a public access website in order to provide information about the

project and also about the results obtained. This is very important to keep informed the

partners, European health authorities, scientific community, media and citizenship.

It contains the following sections:

The ODEQUS Project: Project introduction and summary

Partners Directory: List of the partner organizations

Calendar of events

Contact Us: Address of the project coordinator and contact form to send comments,

requirements and suggestions

Access to the private virtual community

Study Protocol

15

Private virtual community

The virtual community allows the communication among the partners, the access to a

specialized database and the partners’ closeness towards the project. The users are:

Project coordinator Associated partners Donation Experts Collaborating partners Consultants Teachers

The participation in the virtual community depends on the Coordinator authorization by means

of a private user name and password.

The virtual community informs the partners about the project development, bearing in mind all

the milestones and deadlines. It also allows all the participants to share working files and

comments by means of the working folders and the forum.

Study Protocol

16

It contains the following sections:

General information about the project including:

Project technical description

Project budget and financial management

Grant agreement

Project management guidelines

Communication plan

Contact details from the coordinator, partners, donation experts and consultants.

Common agenda in which all the milestones and activities will be registered and

updated.

Working folders: areas created to allow users to upload and download the working files (drafts, proposals…)

Forum: a communication area for discussion by means of posted messages that can be replied.

Chat: a tool for communication on time.

Theoretical contents: Training documents produced by the teachers and consultants.

Bibliography in Quality in the Donation Process.

Study Protocol

17

3. Project development

Study Protocol

18

3.1 Scientific Working Groups (SWG) 12 Donation Experts named by the ODEQUS associated partners, will be divided in 4 Scientific Working Groups: SWG for Donation after Brain Death (DBD)

Donation Experts:

Busic, Mirela (Croatia) Charpentier, Julien (France) Gavranović, Zeljka (Croatia) Guasch, Xavier (Spain) Procaccio, Francesco (Italy)

Tasks:

Define the best practices in the DBD process.

Create Quality Indicators to evaluate the DBD process and outcomes.

Apply the Quality Indicators and the evaluation tools in a national hospital.

Perform external evaluations (Auditing) in, at least, one hospital from other European country/ies.

Report the results of the external evaluations (Auditings)

Disseminate Quality System created by ODEQUS project at national level.

SWG for Donation after Cardiac Death (DCD)

Donation Experts:

Escalante, José Luis Falvey, Sue Györi, Georg

Tasks:

Define the best practices in the DCD process.

Create Quality Indicators to evaluate the DCD process and outcomes.



Report the results of the external evaluations (Auditings)


Study Protocol

19

SWG for Living Donation (LD)

Donation Experts:

Czerwiński, Jarosław Turcu, Rosana Jynge, Öystein

Tasks:

Define the best practices in the LD process.

Create Quality Indicators to evaluate the LD process and outcomes.



Report the results of the external evaluations (Auditings).


SWG for Survey and Auditing Donation Experts:

Lauchart, Werner Maio, Rui Gómez, Maria Paula

Tasks:

Create the auditing tools (Manual). Train 1 professional in each partners’ countries in using the auditing tools.

Audits’ implementation. Evaluate the usefulness of the auditing tools.

Report the conclusions about the usefulness of the Quality Indicators and the evaluation

tools.

Study Protocol

20

3.2 Working Packages (WP):

According to the project management aspects, all the partner organisations were distributed in 8

working packages in order to organize the global activities of the project:

WP 1 – Coordination of the Project Description: Actions undertaken to manage the project and to make sure that it is implemented as planned. Work package Leader: IL3 List of the partners involved: ABM, ASST, DSO, DTI, FITOT, FPT, KI, MUW, MHSW, NHSBT, Poltransplant, SERMAS. Description of the work:

This Working Package will deal with the project's coordination and management. Three

Transnational Meetings will be held,-a Kick-off Meeting, in Leuven (Belgium), an Intermediate

Meeting, in Barcelona, and a Final Meeting, in Barcelona. Collaborating partners will only assist

to the Kick-off Meeting. Nonetheless, they will be able to participate in all meetings thanks to the

telepresence communication tool.

An Steering Committee (SC) will be defined at the Kick-off meeting as the management forum

and decision making tool of the project and the organ to achieve consensus in case of severe

conflict or disagreement. The Steering Committee will be formed by at least one person from

each participating entity. Three Steering Committee Meetings are already foreseen, (at the Kick-

off, Intermediate and Final Meeting). Collaborating partners will always join the Steering

Committee meetings technical debates through the telepresence communication tool. They will

only assist to the final SC, that will take place at the Final Meeting.

Further SC meeting will be possible if necessary. These SC meetings would be virtual meetings

where the telepresence communication tools will be used.

To create an organ donation network among health care professionals implementing a safe and

standardized programme of organ donation in the ODEQUS Consortium. Through this, the

entire population benefits from its QS.

IL3 as WP1 leader, will prepare a Communication Manual, and an Administrative and Financial

Manual that will be shared and agreed with partners at the Kick-off meeting. The two of them

will served as the main tools to rule the project and help participants to participate, debate,

develop the action, make follow-up and reporting. IL3 will be responsible for the good

communication between partners, the good financial management of the projects and the

delivery of project's products in due time.

Study Protocol

21

The Administrative and Financial Manual will determine the procedures and measures to

coordinate and develop the project, the roles of all partners -coordinating partner, associated

partner and collaborating partners, -responsibilities, duties, activities, etc.- and the decision-

making measures to assure a good follow-up of the project and the achievement of the

expected results. It will also establish the Steering Committee organisations and rules for

decision making. It will also explain technical and financial reporting and the tasks and calendar

to be developed by each partner entity.

The Communication Manual will provide specific contingency tools to assure participation,

consensus and agreements on the development of the deliverables and expected results in due

time, including: communications pathways and decisions-making tools, to solve disagreements

and conflicts and achieve the biggest consensus. Strict follow-up and strict time-lines to comply

with deadlines will also be used. Finally, from the scientific point of view, flexibility to review the

newest publications to adapt the path of the project to them will be used as a contingency tool

that enables the project to adapt itself to the latest scientific research. In case of serious

disagreement the STC will be in charge of arriving to a consensus.

Finally, as project's coordinator and WP1 leader, IL3 will act as the representative of the

consortium and will be responsible for the communication and technical and financial

justification of the project with the European Commission.

List of deliverable(s) linked to this work package

Deliverable No. Deliverable title

1 Interim Report

2 Final Report + Final Evaluation Report of the Project

3 Layman Brochure

10 Study Protocol

Milestones reached by this work package

Milestone title Month of achievement

1 Kick-off Transnational Meeting (to be held in Leuven - Belgium) 2

2 Intermediate Transnational Meeting (to be held in Barcelona - Spain) 13

3 Final Transnational Meeting (to be held in Barcelona - Spain) 33

Study Protocol

22

WP 2 – Dissemination of the project Description: Actions undertaken to ensure that the results and deliverables of the project will be made available to the target groups. Work package Leader: IL3 List of the partners involved: ABM, ASST, DSO, DTI, FITOT, FPT, KI, MUW, MHSW, NHSBT, Poltransplant, SERMAS Description of the work:

The Project's Dissemination Plan will assure that all relevant stakeholders and target groups get

to know the project: project's partners, national health authorities, NGOs, donor hospitals,

transplant centers and coordinators, tissue banks, critical care members, ethicists, physicians,

patient associations, pharmaceuticals, insurance companies, specialized and general media,

donors, donor’s families, waiting candidates, recipients and citizenship.

The above mentioned will be taken into account by means of the following actions:

All partners will promote among their national competent authorities, as well as national

transplant coordinators about the project development and its results. It will be broadcasted in the meetings addressed to the Action Plan in Brussels. It may be included in directive recommendations, and /or public health policies. It will be released in scientific meetings, publications, congresses, etc. Mass media broadcasting to achieve a high impact in the society. The National Authorities in charge of organ donation in the 27 Member States will

receive a copy of the deliverables 6, 8 and 9, together with a questionnaire about the feasibility and feedback of the project, so that they can implement the QS, QI, DGS and audits in their countries. When the first set of indicators developed by the partners consortia is agreed, the coordinating partner will contact experts in the 27 MS and distribute the first results. The first set of indicators may be distributed by means of the ODEQUS’ website or by e-mail. The 27MS experts will be asked for feedback, using the Delphi method, and comments will be taken into account to define QS and QI.

The key message will be related to the improvement of organ quality and safety thanks to the

project achievements, results and deliverables. According to the audience, the message,

dissemination tool and disseminated product/deliverable will be different.

ODEQUS dissemination will be mainly electronically done in order to protect the environment

and take advantage of the new technologies of information and communication, as a

consequence, only a short paper edition of the deliverables is foreseen Hence, ODEQUS will

make dissemination through an specific Website that will serve both as an internal working tool

for partners and as a dissemination tool that will make available to the scientific and medical

community those products and deliverables. The Website will also include the Data Base

elaborated by WP6. Also, a promotional leaflet will be elaborated and edited within the first

three months of the project and send to partners to be shared with practitioners and key health

Study Protocol

23

decision-makers on organ donation in their countries. Moreover, the project will disseminate

both in paper and electronic version the main products elaborated. Hard copies of these

products will be send to the 27 National Authorities in charge of organ donation in the Member

States together with an e-mail, inviting them to make dissemination of these deliverables among

their national health structures. A hard copy edition of the Final Report will be also issued and

addressed to the same target group, (National Authorities in charge of organ donation and

transplantation).

All documents will be available in English. The FPT partner will be responsible for its edition and

distribution to partners for its dissemination.

Finally, a Press Conference will take place at the Final Meeting. It will help to disseminate the

project results within a wider scope, -not only to professionals and patients but also to journalist

and citizenship as such-.

Additionally, the coordinating partner will be ready to provide information on the project to DG

SANCO in a format so that it could contribute to disseminate the project at the DG SANCO

website and newsletters.

The ODEQUS Consortium will be built up as a European Network addressed to identify and

implement QS in all the EU member states. We aim at spreading the ODEQUS in 100 hospitals

(approximately 4 hospitals per state member) within 5 years.

Overview table showing the distribution and target for all project deliverables

Title Distribution Channel Target Audience

1 Interim Report Internet (through project's Website)

Project's promoter, associated and collaborating partners

2 Final Report + Final Evaluation Report of the Project

Internet (through project's Website)


3 Layman brochure Internet (through project's Website)


4 Website Internet (through project's Website)

Project's promoter, associated and collaborating partners health authorities in organ donation and transplantation, hospital directors, transplant coordinators and physicians, patients associations,media and citizenship

5 Comparative Study on Quality Standards of best practices in the 3 types of organ donation in 11 European countries

Internet Project's consortium, health authorities in organ donation and transplantation, hospital directors, transplant coordinators and physicians, patients associations,media and citizenship

6 Manual on QS and QI on the 3 types of organ donation

Internet Project's consortium, health authorities in organ donation and transplantation, hospital directors, transplant coordinators and physicians

7 Data Base Internet and Paper Copies, (these ones limited to the 27 Member States National Authorities on organ Donation and transplantation)

Project's consortium, health authorities in organ donation and transplantation, hospital directors, transplant coordinators and physicians, patients associations

8 Audit System + Audit Guide for organ donation services

Internet Project's consortium,health authorities in organ donation and transplantation, hospital directors, transplant coordinators,

Study Protocol

24

physicians

9 Training course Manual on QI, Data Gathering System (DGS) an audit for organ donation professionals and services

Internet and Paper Copies, (these ones limited to the 27 Member States' National Authorities on organ donation and transplantation)

Project's consortium,health authorities in organ donation and transplantation, hospital directors, transplant coordinators, physicians

10 Study Protocol Internet and Paper Copies, (these ones limited to the 27 Member States' National Authorities on organ donation and transplantation)

Project's consortium,health authorities in organ donation and transplantation, hospital directors, transplant coordinators, physicians



5 Comparative Study on Quality Standards of best practices in the 3 types of organ donation in 11 European countries



1 Edition and dissemination of a promotional leaflet of the project for the National Authorities

3

2 Website already available and working as a dissemination toos and a work tool for partners

5

Study Protocol

25

WP 3 – Evaluation of the project Description: Actions undertaken to verify if the project is being implemented as planned and reaches the objectives. Work package Leader: IL3 List of the partners involved: ABM, ASST, DSO, DTI, FITOT, FPT, KI, MUW, MHSW, NHSBT, Poltransplant, SERMAS Description of the work IL3 will design a project's follow-up and Evaluation System with two different parts. The first one will deal with the evaluation of the project's process and procedures: management, actions execution, and the financial and technical reporting. It will also make follow-up of communication and participation within the consortium in the project's development. This part of the system will be addressed to provide key tools to make follow-up and then check the evolution of the project and provide the necessary tools and recommendations to improve the project's rythm of development or introduce the necessary actions to guarantee the implementation of the action and the achievement of results. IL3 will draft Specific templates as part of the system. This will help to make follow-up and evaluation through tools for all partners. The other part of the evaluation system will be addressed to make follow-up on the project's achievement of results and objectives. This evaluation process will be directly linked in the second half of the project to the Audit System and the Audit visits that will be developed. It will be based on QS and data gathering system previously defined together with the process, output and outcome indicators defined and listed below. In order to do this evaluation, IL3· will provide again specific templeates and tools and instructions to make follow-up on this indicators linked with the project's objectives. At the end of each of the three years IL3 will make the evaluation activities needed to make follow-up and evaluation of both procedures and achievement of results and objective. The follow-up and evaluation system will include specific evaluation templates that will be sent to and filled in by partners, together with instructions to make data-collection. It will also include telephone evaluation interviews to partners and checklist to verify the execution of activities and the achievement of results. Each partner will share the information with IL3, as "national follow-up and evaluation reports". They will have to elaborate three national evaluation reports, at the begining,at the middle and at the end of the project. IL3 will be in charge of collecting all data and preparing three consolidated evaluation reports, one per year-. The first two evaluations will serve to check the project's development and introduce correcting measures if need. The third one will evaluate the last year and the project's implementation as a whole. Together with the Auditing recommendations and the Third Report, a a Project's Final Evaluation Report will be prepared by IL3. The document will serve as a key tool for the external evaluation foreseen for the end the project. A specific summarized and/or attractive version of the Project's Final Evaluation Report will be prepared in order to shared it with project's target groups, -it will not include any administrative or financial information-. The document will be available on the project's website. It will be also disseminated by partners within their countries and IL3 will share it in an specific e-mail with the National Authorities in charge of organ donation and transplantation in each of the 27 Member States.

Study Protocol

26

The follow-up and evaluation system will be shared by IL3 with partners and agreed with them in the project´s Kick-off Meeting in Brussels. Special Remark:

* The definition of process, outcome and output indicators (that are used to measure the process and impact of the ODEQUS project) is to be discussed, revised and specified during the Kick-off meeting, agreed upon by the project partners and their concrete measurement described in D10 Study Protocol. The evaluation report will use these

indicators for evaluating the project and its impact.

List of specific objectives:

Specific objective 1: To identify and develop Quality Standards of best practices in the 3 types of organ donation (DBD, DCD and LD) in the European Union in order to define QI that help improving organ donation services and donor rates.

Process indicators Output Indicators Outcomes indicators At least 2 standards of best practices on the 3 types of organ donation are identified by each ODEQUS project partner

The standards of best practices identified on the 3 types of organ donation identified in the ODEQUS project are selected, systematized and disseminated in participant countries.

Comparative Study on Quality Standards of best practices in the 3 types of organ donation in 11 European countries. Outcome indicator: validate tools which can be applied for the participant countries.

Specific objective 2: To define and create Quality Indicators to determine and measure the organizational structures and clinical procedures on the 3 types of organ donation in European organ donation services.

Process indicators Output Indicators Outcomes indicators At least 60% of project partners contribute to the identification/creation of quality indicators in the fields foreseen

Standard measures/aims/percentages on quality indicators on at least 11 organizational structure areas and 11 clinical procedures agreed by project partners.

Manual on QS and QI on the 3 types of organ donation. Outcome indicator: the QI are the tools for gathering the information and must be valid and useful for all participating hospitals.

Specific objective 3: To develop Auditing procedures to evaluate and make follow-up on the use and implementation of the quality indicators defined and applied in European organ donation services.

Process indicators Output Indicators Outcomes indicators At least 60% of partners contribute to the Audit Guide with best national Standard Auditing procedures on organ donation.

At least 40% of organ donor services/hospitals implementing the ODEQUS project quality indicators have a positive Audit during the project's implementation

Audit System + Audit Guide for organ donation services. In order to validate the tools, at least 2 auditors will carry out the audit in the each hospital, using the same tools. Outcome indicator: comparing results from both auditors report.

Specific objective 4: To introduce and put into practice the use of the QI and auditing procedures – both for organizational structures and clinical procedures of organ donation services- defined and based on QS in European organ donation services.

Process indicators Output Indicators Outcomes indicators At least 60% of professionals attending to each of the 2 training foreseen use the ODEQUS Quality System in their hospitals.

The ODEQUS Quality System is improved thanks to the analysis of at least 3 organ donor services using the System and provide feedback in order to establish recommendations.

Training course Manual on QI, Data Gathering System and Audit for organ donation professionals and services. Outcome indicator: the usefulness of the tools introduced in each material for each participating country.

Study Protocol

27



4 Website



1 Elaboration and dissemination of a follow-up system among project partners. 3

2 Elaboration of the First internal evaluation report 14

3 Elaboration of the Second internal evaluation report 26

4 Elaboration of the Final Project's Evaluation report 36

Study Protocol

28

WP 4 – Identification and systematization of quality best practices in DBD, DCD and LD in 11 Member States Description: WP4 will work to establish quality standards of best practice in DBD,DCD and LV in 11 countries as a first step that will help to build and create common quality indicators and auditing procedures that improve the quality of the process of organ donation praxis developed nowadays. Work package Leader: FITOT List of the partners involved: ASST, KI, MUW, MHSW, NHSBT Description of the work: This Working Group will make an intensive work to identify quality standards on best practices on the 3 types of organ donation -DBC, DCD and LV- in 11 countries. They will make and exhaustive literature review and search for evidence based on the topic in all the participant countries. They will also have the change to debate and make analyses on the information found at a working meeting that will take place in Paris. On Month 8 this WP will have already elaborated and disseminated among partners a Comparative Study on the quality standards on best practices on the 3 types of organ donation. The study will be a key tool for the development of the next WP, deliverables and project´s outcomes.This WP will held a Working Meeting through the Virtual Communication Platform in a two day meeting format.

Specific objectives of this work package

Objective No. Specific objective title

1 To identify and develop Quality Standards of best practices in the 3 types of organ donation (DBD, DCD and LD) in the European Union in order to define QI that help improving organ donation services and donor rates.

List of deliverable(s) linked to this work package Deliverable No. Deliverable title

6 Manual on QS and QI on the 3 types of organ donation



1 Working Meeting WP 4(To be developed with the Telepresence communication platform)

7

Study Protocol

29

WP 5 – Development of QI and Data Gathering System on the organizational structure of organ donation services Description: WP5 will identify, create and develop QI and Data Gathering System on the organizational structure of organ donation services. Experts literature review, analyses, debate and experience will be put together with the results of WP4 to create these tools and improve organ donation process. Work package Leader: ABM List of the partners involved: ABM, FPT, MHSW, SERMAS Description of the work This work package will work in permanent coordination with WP 6, at the same time and with a similar issue, in this case, the creation, identification and development of quality indicators and a data gathering system on the organizational structure of organ donation services. Through literature review and evidence based research they will get to know previous work on the issue and will base their work in the conclusions of the Comparative Study elaborated by WP4. The specific methodology and fields to develop each indicator will include the name and definition of the specific aspect to measure; the justification; the formula,-mathematical way of measuring the importance of the indicator-, the explanation of the terminology, the population, the type of indicator, the data source for measuring the indicator, the Standard,- expressed in percentage of application-, and commentaries -literature reference-. These WP5's members will held a Working Meeting through the Virtual Communication Platform in a two day meeting format. Subcontracting to support QI identify. is foreseen at WP5.



2 To define and create Quality Indicators to determine and measure the organizational structures and clinical procedures on the 3 types of organ donation in European organ donation services.



7 Data Base



1 Working Meeting WP5 and WP6 (To be developed with the Telepresence Communication Platform)

11

Study Protocol

30

WP 6 – Development of QI and Data Gathering System on clinical procedures of organ donation services Description:

WP6 will identify,create and develop QI and Data Gathering System to measure the clinical procedures followed by organ donor services.Experts literature review, analyses, debate and experience will be put together with the results of WP4 to create these tools and improved organ donation process. Work package Leader:

FITOT List of the partners involved:

ASST, KI, MUW, NHSBT Description of the work

WP 5 and WP 6 will be run simultaneously and in conjunction with each other. WP 6 will

identify, create, and develop quality indicators and data gathering system on clinical procedures

of organ donation services, based on the results of WP4.

The standards of clinical procedures will be reviewed and developed in the different parts of

every clinical process for DBD, DCD and LD being: Scope of performance standards; Donor

identification; Clinical evaluation; Death diagnosis; Family / personal consent; Donor

maintenance; Organ viability evaluation and placement; Surgical organ recovery and Organ

preservation. On top overall indicators measuring impact will be translated through number

donors; number organs and number transplants. Also, they will be responsible for the

elaboration of a Data Base that will be linked to the Website and that will enable partners and

trained professionals of the 11 organ donation services collect and work on indicator's data

during the implementation phase(WP8).These WPs will held a Working Meeting through the

Virtual Communication Platform in a two day meeting format. Subcontracting is foreseen at

WP6.



2 To define and create Quality Indicators to determine and measure the organizational structures and clinical procedures on the 3 types of organ donation in European organ donation services.



7 Data Base



1 Working Meeting WP5 and WP6 (To be developed with the Telepresence Communication Platform)

11

2 A Data base linked to the Website and already available for partners and other experts linked to the project Quality System data implementation

15

Study Protocol

31

WP 7 – Development and use of Audit procedures and tools for organ donation services. Description: WP7 will develop and Audit System to check the application of QI and data gathering system in organ donor services. It will be responsible for the elaboration of an Audit Guide that helps to use the Audit System. It will also be responsible for the follow-up of the 11 Audit visits foreseen. Work package Leader: DSO List of the partners involved: DSO, DTI, Poltransplant Description of the work Based on the analysis and the results coming from WP4, WP5 and WP6, WP 7 will be concentrating on the development of an audit system to be implemented at least in 2 and at most in 5 hospitals. The audit system needs to be developed to assure the application of QI and their related data gathering systems in all participant hospitals. In conjunction with the development of the audit system, an audit guide will be developed. This WP will be also responsible for the follow-up of the audit visits that will take place at the end of the Quality System's implementation period in the donation services.



3 To develop Auditing procedures to evaluate and make follow-up on the use and implementation of the quality indicators defined and applied in European organ donation services.



8 Audit System + Audit Guide for organ donation services

9 Training course Manual on QI, Data Gathering System (DGS) an audit for organ donation professionals and services



1 Working Meeting WP7 (to be developed with the Telepresence Communication Platform).

17

2 Audit visits 2 to 5 hospitals involved on the implementation of the ODEQUS QI and data gathering system.(from M 30 to M 31, in 3 countries).

30

3 Audit visits at least 2 hospitals involved on the implementation of the ODEQUS QI and data gathering system(From M32 to M33,in other countries).

32

Study Protocol

32

WP 8 – Training and application of QI, data gathering system and audit tools in organ donation services Description: WP8 will be responsible for the training of health professionals in the QS -indicators, data gatherin system and audit- and for the validation and implementation of the System in 3 and 11 European organ donor services respectively.WP8 will collect the recommendations after the QS implementation. Work package Leader: IL3 List of the partners involved: ABM, ASST, DSO, DTI, FITOT, FPT, KI, MUW, MHSW, NHSBT, Poltransplant, SERMAS Description of the work

After the results and materials of the previous WP are available, WP8 will be concentrating on

the professional training of everyone involved in the process within the 11 participant hospitals.

WP8 will first develop and implement the training of clinicians and/or health care professionals

part of the management system in every participating hospital. Two participants from each of

the 11 participating hospitals will be trained on the identification and implementation of QI, Data

Gathering System and its validation; during a training in Portugal.

Afterwards WP8 will develop and implement a training course for the 11 auditors involved (1 per

participating hospital) in auditing from 2 to 5 hospitals.

The training programs and the technical and logistic implementation of both trainings will be

leaded by ASST with the support of a specialized subcontracting entity.



4 To introduce and put into practice the use of the QI and auditing procedures – both for organizational structures and clinical procedures of organ donation services- defined and based on QS in European organ donation services.



10 Study Protocol



1 Training on Quality Indicators and Data Gathering System addressed to health professionals of the 11 countries which have associated partners.

7

2 Training on Audit for organ donor services addressed to health professionals of the 11 countries which have Associated partners.

18

3 Recommendations on the use of the Quality System (that will be part of the Final Report).

34

Study Protocol

33

3.3 Timetable specification*

Legend: X - Work package duration (start to final months)

D - Month when deliverable will be produced M - Month when milestone will be reached

* The dates for reaching the milestones and producing the deliverables might change according to the project development.

Study Protocol

34

Acronyms List Partners: IL3 – Institute for LifeLong Learning

ABM – Agence de la Biomédecine

ASST – Autoridade para os Serviços de Sangue e da Transplantação

DSO – Deutsche Stiftung Organtransplantation

DTI – Donation and Transplantation Institute

FITOT – Fondazione per l’Incremento dei Trapianti d’Organo e Tessuti

FPT – Fundatia Pentru Transplant

KI – Karolinska Institute

MUW – Medizinische Universitaet Wien

MHSW – Ministry of Health and Social Welfare (Republic of Croatia)

NHSBT – NHS Blood and Transplant (Directorate of Organ Donation and Transplantation)

SERMAS – Servicio Madrileño de Salud

FIBHGM – Fundación para la Investigación Biomédica del Hospital Gregorio Marañón

Collaborators: HNBTS – Hungarian National Blood Transfusion Service

HTO – Helenic Transplant Organisation

MAHC – Medicalpark Antalya Hospital Complex

MDH – Mater Dei Hospital

ST – Slovenija Transplant

Other Acronyms: DBD – Donation after Brain Death

DCD – Donation after Cardiac Death

LD – Living Donation

QC – Quality Criteria

QI – Quality Indicators

SC - Steering Committee

SWG – Scientific Working Group

WP – Working Package

study protocol - europa · av. de sarrià 137, entr. 4a 08017 barcelona - spain phone: +34 93 252...

Documents