Registro Mundial 2

GLOBAL DATABASE ON DONATION AND TRANSPLANTATION: GOALS, METHODS AND CRITICAL ISSUES (www.transplant-observatory.org) Authors:

Beatriz Mahillo. Medical Unit. Organizaciรณn Nacional de Trasplantes Mar Carmona. Technical Unit. Organizaciรณn Nacional de Trasplantes Marina ร lvarez. Technical Unit. Organizaciรณn Nacional de Trasplantes Luc Noel. Department for Health Systems Policies and Workforce. CPR/HPW/HSS. World Health Organization Rafael Matesanz. Medical Unit. Organizaciรณn Nacional de Trasplantes

Address for Correspondence: Beatriz Mahillo Duran Organizacion Nacional de Trasplantes C/ Sinesio Delgado 6-8.

28029 Madrid. Spain Fax: (+34) 902 300 226. Telephone: (+34) 902 300 224. e-mail: bmahillo@msssi.es

ABSTRACT The Global Database on Donation and Transplantation represents the most comprehensive source to date of worldwide data concerning activities in organ donation and transplantation derived from official sources, as well as information on legal and organizational aspects. The objectives are to collect, analyse and disseminate this kind of information of the WHO Member States and to facilitate a network of focal persons in the field of transplantation. They are responsible for providing the legislative and organizational aspects and the annual activity practices through a specific questionnaire. 104 out of the 194 WHO Member States that cover the 90% of the global population contribute to this project. Although we know the numerous limitations and biases as result of the different interpretations of the questions, based on cultural factors and language, there is no other similar approach to collect information on donation and transplantation practices all over the world. The knowledge of demand for transplantation, availability of deceased and living donor organs and the access to transplantation is essential to monitor global trends in transplantation needs and donor organ availability. Information regarding the existence of regulatory oversight is fundamental to ensure the ethical practice of organ donation and transplantation.

BACKGROUND The Global Database on Donation and Transplantation is being recognised as the global registry of reference, containing information on legislative and organizational aspects and also aggregated data on donation and transplantation activities of the World Health Organization (WHO) Member States.

Previous to the creation of the Global Database, the international activity data on organ, tissues and cells were collected in organ specific registries on donation and transplantation procedures1; voluntary registries2,3 and also registries for recipients’ follow up

4-6

. Nevertheless there was not a single system established worldwide to

collect and assess national data for each transplanted organ.

The inability to estimate the donation and transplantation practices all over the world led the World Health Assembly to request the collection of global data on the practices, safety, quality, efficacy, epidemiology and ethical issues of allogeneic transplantation in Resolution WHA57.187. The need to continue collecting those data to be aware of the global practices was reiterated in Resolution WHA63.228 in May 2010.

The WHO devised a strategy to accomplish the requirements of the WHA57.18 resolution which included, inter alia, the creation of a global database on donation and transplantation practices and the legal and organizational aspects in Member States.

WHO sought for collaborating partners that could fund the development and maintenance of such tool, also contributing with human and technical resources. It was in 2005 when Spain, through its national agency the National Organization of Transplants (ONT), took the lead to carry on this mandate and signed an agreement

with WHO to mainly collaborate in the design and creation of the global database. The agreement has been extended every two years since then.

The ONT was also designated as a WHO Collaborating Centre to accomplish this particular strategy, owing to its large experience in the management of the international database on transplantation derived from the Newsletter Transplant of the Council of Europe and its extension to the Latin American countries, as well as its network of key contacts in the field of transplants.

In the same line, the Global Observatory on Donation and Transplantation (GODT)9 was created as a web platform that gathers general information and the Global Database. The global availability of this kind of information is recognized as a prerequisite to demonstrate transparency, equity and to monitor transplant systems in countries. The software also allows professionals and general public to have an overview of the legal and organizational aspects in very different settings and countries. The GODT website is running since 2007.

SPECIFIC

OBJECTIVES

OF

THE

GLOBAL

DATABASE

ON

DONATION

AND

TRANSPLANTATION: To collect, analyse and disseminate information on legislative and organizational aspects, in addition to the annual aggregated data on donation and transplantation activities of the WHO Member States.

To facilitate the establishment and maintenance of the network of focal persons in the field of transplantation.

METHODS Scope The scope for data collection in the Global database includes the 194 Member States in the six WHO regions: Africa (AFR), The Americas (AMR), Eastern Mediterranean (EMR), Europe (EUR), South-East Asia (SEAR) and Western Pacific (WPR).

Contributors The national health authorities have designated a key person from each Member State who joins the network and acts as a focal point.

Data Collection Figure 1 outlines the main steps in the development of the Global Database. A WHOONT working group was established to design, develop, maintain and update the GODT website and its Global Database. As part of the work plan, the group designed a specific questionnaire to collect the information concerning organizational structures, legislative systems and activities of donation and transplantation procedures for organs, tissues and cells. The questionnaire was circulated for first time in 2007 among the identified contact persons in Member States.

Most of the questions about organizational structures and legislation are qualitative with yes/no answers, nevertheless there are others designed to include comments and brief explanations. Quantitative aggregated data are used for the donation and transplantation activities.

Table 1 summarizes the main items of the Global Database questionnaire. A Guide for Users was created to facilitate the comprehension and fulfilment of the questionnaire.

Explanations were provided to some of the questions in order to avoid the different interpretations depending on cultural factors, language or the organizational and legal frameworks

in

the

respondent

countries.

Likewise, the WHO developed the "Glossary of Terms used in Cell, Tissue and Organ Donation and Transplantation"10 in order to increase harmonization in the understanding of the survey.

The focal points are responsible for providing the legislative and organizational aspects and the annual activity practices for the database. Personal communication via e-mail or phone is used to clarify any discrepancy or concern about the data.

The revision and validation of data by the focal points are the cornerstone for this phase of the process.

After several years compiling data for the global database, some limitations have been observed in the use of the questionnaire. Therefore, we have conducted a consultation process among Member States with the aim of improving it. The new questionnaire is only focused in organs and addresses qualitative and quantitative aspects of donation and transplantation matters. A similar process will be followed for tissues and cells.

Figure 2 shows the workflow for the annual collection of activity data.

Source of data for the Global Database The currently available donation and transplantation data come from two sources: The international Newsletter Transplant database, which provides aggregated activity data since 2000 from most of the European Member States, United States of America,

Canada, New Zealand, Australia, and Latin America and the WHO global questionnaire that is annually addressed to Member States in different regions, AFR, EMR, SEAR, WPR as well as some Member States in EUR. Other data sources The United Nations Population Fund report is used as the data source for estimates of population size, unless a more up-to-date figure is available from an official source.

Figures for Human Development Index (HDI) and other development indicators are obtained from the United Nations Development Programme (UNDP).

ANALYSIS OF THE ACTIVITY DATA Since the data for cells and tissues are very limited so far, only information pertaining to solid organ transplantation has been analyzed on a yearly basis.

National activity data is examined in both regional and global contexts. For annual reports we use descriptive statistics. Data are presented in absolute numbers and rates per million population (pmp). Global and regional rates are calculated by applying denominator populations of those countries that were able to provide estimates of donation and transplantation activity.

The annual report also includes descriptive maps of kidney, liver, heart and total transplant activities and deceased donation activities worldwide. Those maps are produced by the Public Health Information and Geographic Information System at WHO derived from a datasheet of the Global Database. As an example Figure 3 shows the distribution of organs transplanted globally in 2010.

We also apply inferential statistics to study the relation between some selected development indicators (as HDI and Total Expenditure on Health as % of Gross

Domestic Product) and donation and transplantation activities, legislation and organizational structures.

To solve the problem of dropout or missing data, we use the last observation carriedforward to avoid the loss of countries with no available data from the previous year. It is a common method used in clinical trials and longitudinal studies where individuals are followed. This method allows examining the trends over the time.

The annual study forms the basis for possible situation analyses in individual countries, and shows the utility of the GODT as a comprehensive tool by which certain issues of international concern may be evaluated comparatively.

The analyses are performed with SPSS software.The general public can also look up all figures and obtain basic statistics, by means of tables or charts, using the GODT website’s software.

CRITICAL ISSUES AND KEY FINDINGS This global database represents the most comprehensive source to date of worldwide data concerning activities in organ donation and transplantation derived from official sources, as well as information on legal and organizational aspects. 104 out of the 193 WHO Member States (53.9 %) have contributed to the database. The respondent Member States cover the 90% of the global population, thus they can be considered as quite representative of world practices.

A key issue on the collection of data is the use of the questionnaire. Although we assume the numerous limitations and biases as result of the different interpretations of the questions, based on cultural factors and language, there is no other similar

approach to collect information on donation and transplantation practices all over the world.

Completing the information about the organizational and legislative aspects was difficult for the respondent countries, owing to the existing differences for the practice and regulation of organ donation and transplantation. Therefore, we have made efforts to reach more uniform criteria to collect, analyze and understand the information.

The questionnaire has followed a two years consultation process, resulting in an improved version11. Currently it is too early to assess the impact of this new version, since it has been recently circulated for first time.

The experience acquired after several years dealing with the Global Database allows us to identify some key elements to build and develop an international registry: a) to keep in mind the scope that the registry should have, i.e. who it is intended for and who will provide the information; b) the language barriers, noting that people involved in the process may not be fluent in the language of the registry; c) the cultural differences that may exist and also those derived from the legal frameworks and organizational structures in diverse settings, that can be biases when responding the questionnaire.

The implementation of tools such as a glossary of terms and definitions or instructions to fulfill the questionnaire can help to minimize those differences. Also, the establishment of mechanisms to harmonize the collection of data is a useful approach to avoid the personal interpretation of the questions and responses and to obtain more reliable data. The global database is the result of dedicated efforts to strengthen

the network of focal points and to maintain a close collaboration with them, and it is also the result of their valuable contribution to providing annual data.

The knowledge of demand for transplantation, availability of deceased and living donor organs and the access to transplantation is essential to monitor global trends in transplantation needs and donor organ availability. Likewise, information regarding the existence of legislation and regulatory oversight is fundamental to ensure safety and the ethical practice of organ donation and transplantation in accordance with international standards.

REFERENCES 1. United Network for Organ Sharing. Available at: http://www.unos.org. Accessed November 15, 2012.

2. International Registry of Organ Donation and Transplantation. Available at: http://www.europeantransplantcoordinators.org/clinical-resources/irodat/. Accessed November 15, 2012.

3. Newsletter Transplant of the Council of Europe. Available at: http://www.ont.es/publicaciones/Paginas/Publicaciones.aspx. Accessed November 15, 2012.

4. European Liver Transplant Registry. Available at http://www.eltr.org. Accessed November 15, 2012.

5. International Registry for Heart and Lung Transplantation. Available at: http://www.ishlt.org. Accessed November 15, 2012.

6. International Pancreas Transplant Registry. Available at: http://www.med.umn.edu/IPTR/. Accessed November 15, 2012.

7. WHA57.18 Resolution of the World Health Assembly, May 2004. Available at: http://www.who.int/transplantation/en/A57_R18-en.pdf. Accessed November 15, 2012.

8. WHA63.22 Resolution of the World Health Assembly, May 2010. Available at: http://apps.who.int/gb/ebwha/pdf_files/WHA63/A63_R22-en.pdf. Accessed November 15, 2012.

9. Global Observatory on Donation and Transplantation (GODT). Available at: http://www.transplant-observatory.org. Accessed November 15, 2012.

10. Global Glossary on Terms and Definitions on Donation and Transplantation. Available at:

http://www.who.int/transplantation/activities/GlobalGlossaryonDonationTrans plantation.pdf. Accessed November 15, 2012.

11. Current Global Database Questionnaire. Available at: http://www.transplant-

observatory.org/Pages/Request-Data.aspx. Accessed November 15, 2012.

Table 1. Main items of the Global Database Questionnaire

Organizational System



Official body or specific organization responsible for overseeing and coordination donation and transplantation activities about organs, tissues and cells. Activities, report and funding of this organization.  National Technical Committees / Advisory Boards or Ethical Committees dedicated to donation and transplantation activities.  Surveillance system and reporting of adverse events in the process of transplantation, reactions and untoward consequences in organ transplant recipients. Surveillance system of donation complications in live organ donors.  Registries for the collection and analysis of data on donation and transplantation activities.  National / provincial standards or written instructions or guidance for transplants from deceased or living donors.  National training programs to harmonize practices for staff involved in organ procurement and transplantation.

Legislative System

 

Specific legislation for donation and transplantation activities.

Role of the National Health Authorities in the regulation and oversight of the donation and transplantation activities, included authorization and licence for transplantation.  Legal requirements for quality, efficacy and safety of the donation and transplantation procedures.  Legal requirement for consent to donation from deceased and living donors.  Legal requirements and restrictions for living donation.  Penalties in the event of commerce with donated organs, cells and tissues. Explicit prohibition of organ trafficking in the legal framework.  Distribution and allocation criteria for organs, tissues and cells.  Confidentiality and traceability specified by law.  Import and export of organs, cells and tissues controlled by law.

Activity data

   

Number of transplantation centers.

Organ donation activity.

Organ transplantation activity (kidney, liver, heart, lung, pancreas, small bowel, multivisceral).

Donation and transplantation activity on tissues and cells.

Figure 1. GLOBAL DATABASE ON DONATION AND TRANSPLANTATION: KEY STEPS

Working group/ Network

- ONT/WHO working group: creation and distribution of tasks

Questionnaire

- Design of the ad hoc questionnnaire

- Network of focal points:

- Distribution

a. identification of official focal points

a. User’s guide

b. regular communication c. keep contacts updated

- Improvements: b. Glossary of terms c. New questionnaire

Database

Website

- Conversion of the answers into variables (codification)

- Design and development of the GODT website including:

- Creation of the software

a. Information readily available

- Import of the Newsletter Transplant database

b. Maintenance and continuous improvement

- Annual Data entry - Annual Report

c.Upgrading to higher versions

Figure 2. WORKFLOW FOR THE ANNUAL COLLECTION OF ACTIVITY DATA

Data collection

Data management

Data analysis

• Ad hoc questionnaire sent by E-mail to the national focal points • Reminders (e-mail) • Reception of data • Deadlines: every year in Q3/Q4 • Revision of data and clarification whenever discrepancies are found (by E-mail or phone) • Data entry in the database • Validation, data check and final approval by Member States • Calculation of indicators on donation and transplantation (country, regional and global estimates).

• Further analysis.

• Charts and official maps

• Publication in the GODT website • Presentations / Other Publication

Figure 3. DISTRIBUTION OF GLOBAL ORGANS TRANSPLANTED IN 2010