Executive Only Functions

THE AUSTRALASIAN BONE MARROW TRANSPLANT RECIPIENT REGISTRY

OWNERSHIP, USAGE AND REPORTING

1. INTRODUCTION

The Australasian Bone Marrow Transplant Recipient Registry (ABMTRR) collects summary data on haemopoietic stem cell transplant activity and outcome in Australia and New Zealand. The data and data management team are located at St Vincent's Hospital, Sydney, Australia, and are part of the Bone Marrow Transplant Network NSW and are funded by NSW Health.

2. DESCRIPTION OF THE ABMTRR

The Australian Bone Marrow Transplant Recipient Registry (ABMTRR) was established in 1992 to record details of bone marrow and peripheral blood stem cell transplants throughout Australia. Contributing centres provide registrations of new transplants to the ABMTRR, as well as information on the progress of previous transplant patients. Due to financial constraints no remuneration can be offered, however the ABMTRR is committed to keeping reporting requirements as low as possible and only a small number of data items are asked for. Registry results are reported to medical conferences and written up as scientific papers in appropriate medical journals from time to time. Retrospective investigations of particular disease or transplant types using the ABMTRR as a base are also carried out from time to time. From 1998, the ABMTRR also includes data from New Zealand hospitals and accordingly has now changed its name to the Australasian Bone Marrow Transplant Recipient Registry.

The ABMTRR aims for full enumeration of haemopoietic cell transplants in Australasia each year. All of the hospitals which carry out haemopoietic cell transplants in Australia and New Zealand correspond with the ABMTRR, and this list is assessed for completeness on a regular basis via correspondence with leading clinicians in this field. At the commencement of each calendar year there is a phase of follow-up where each hospital is contacted to ensure they have supplied all of the previous year's registrations. Comparisons with the previous year's results are made for each hospital and any large changes in numbers are discussed with the relevant data managers. Due to the large size of this collection, there are from time to time unavoidable administrative delays leading to incomplete enumeration for a year. For 2002, it is estimated that approximately 99% of all haemopoietic cell transplants in Australia and New Zealand were registered and subsequently analysed.

3. GROUPS / INDIVIDUALS INVOLVED WITH THE ABMTRR

Transplant centres in Australia and New Zealand (currently 34) - provide data on autologous and allogeneic stem cell transplants through registration and update forms completed by data managers. Ultimately the ABMTRR data belongs to these institutions that contribute to it.

The Bone Marrow Transplant Society of Australia and New Zealand (BMTSANZ) - the legal entity formed under the auspices of the Haematology Society of Australia and New Zealand (HSANZ). The BMTSANZ represents all of the contributing centres and thus owns the ABMTRR.

ABMTRR Executive Committee. This committee represents the BMTSANZ in day-to-day supervision of the ABMTRR. The committee members are currently A/Profs Ken Bradstock, Tony Dodds and Jeff Szer, and Ian Nivison-Smith.

St Vincent's Hospital Sydney - the ABMTRR is physically sited at this institution and staff working on the ABMTRR are paid through the St Vincent's payroll system.

St Vincent's Hospital Bone Marrow Transplant Research Unit - this unit comprises a manager / statistician and four data collectors / coordinators. Staff at the unit maintain the ABMTRR, ABMDR and St VincentÕs transplant data collections.

BMT Network NSW - oversees stem cell transplantation within NSW. Transplant centres within NSW have undertaken to continue reporting to the ABMTRR as the preferred way to monitor transplant activity within the state. The NSW BMT Network supports transplantation in NSW through the provision of services and staffing.

The Australian Bone Marrow Donor Registry (ABMDR) - as part of its function, the ABMDR monitors the outcome of unrelated donor transplants throughout Australia. The ABMDR currently funds a data collection of activity and outcome details for all unrelated donor transplants carried out in Australia. This collection is carried out by Research Unit staff using ABMTRR registrations as the initial list.

The Center for International Blood and Marrow Transplant Research (CIBMTR) - the CIBMTR (a merged entity comprising the old International Bone Marrow Transplant Registry and the research division of the National Marrow Donor Program of the USA) collects records of allogeneic transplants worldwide. Most Australian and New Zealand allo centres correspond to the CIBMTR, either using their full form or their TED (Transplant Essential Data) form.

Arrow Foundation - the Arrow Foundation is a charity that raises money for stem cell research and patient support. Arrow has financially supported the SVH BMT Research Unit for many years. Currently Arrow funds the salaries of 2 staff at the unit.

NSW Health Department - NSW Health provides substantial funding to the NSW BMT Network through the GMTT program.

Prof David Ma. Medical / scientific adviser.

4. CURRENT STAFFING

The St Vincent's Hospital BMT Research Unit currently comprises the following staff:

Unit Manager / Statistician. Part-time 4 days per week. Funded by NSW Health. Duties: Manage data collections: ABMTRR, ABMDR unrelated transplants, St Vincent's data collection. Participate in analyses from special studies proposed by BMTSANZ members or NSW BMT Network members.

Data collector: Full-time. Funded by NSW Health. Duties: Collect data on allogeneic transplants at St Vincent's and Sydney Children's Hospitals and report to the ABMTRR, ABMDR and other collections as necessary.

Data co-ordinator, NSW BMT Network. Part-time 20 hours per week. Funded by NSW Health. Duties: Enter records of NSW allogeneic transplants onto database. Develop and maintain this database.

Data co-ordinator, ABMTRR. Part-time 16 hours per week. Funded by contributions from Arrow Foundation and ABMDR. Duties: Enter data for autologous and allogeneic transplants throughout Australia and New Zealand onto database.

Data entry officer, ABMTRR. Part-time 10 hours per week. Funded by contributions from Arrow Foundation. Duties: Enter data of allogeneic transplants carried out at St Vincent's Hospital.

5. CURRENT DATA COLLECTIONS

Stem cell transplant data is collected under several different arrangements, although some of these utilise the same reporting form and are entered onto the same database.

Autologous transplants in NSW: data is supplied to the research unit on the request of the NSW BMT Network, using the standard ABMTRR registration form ("green form"). A small fee ($50 + GST) is payable to the centres to compensate for the time spent completing the forms. Data is entered onto the ABMTRR database.

Allogeneic related and unrelated donor transplants carried out in NSW: data is supplied to the research unit on the request of the NSW BMT Network, using the standard ABMTRR registration form ("green form"). This collection is carried out by two data managers who are fully funded by NSW Health through the NSW BMT Network. Data is entered onto the ABMTRR database.

Autologous transplants in Australia ex NSW and New Zealand: data is supplied to the research unit on the request of the BMTSANZ, using the standard ABMTRR registration form ("green form"). No compensation is offered to centres for the time spent completing the forms. Data is entered onto the ABMTRR database.

Allogeneic related and unrelated donor transplants carried out in Australia ex NSW and New Zealand: data is supplied to the research unit on the request of the BMTSANZ, using the standard ABMTRR registration form ("green form"). No compensation is offered to centres for the time spent completing the forms. Data is entered onto the ABMTRR database.

Allogeneic unrelated donor transplants carried out in Australia: detailed data is supplied to the research unit on the request of the ABMDR, using an additional data request form ("blue form"). ABMDR compensates centres $200 (+ GST) for the time spent completing each form. ABMDR also pays the research unit to process and analyse this collection. Data is entered onto an MS Access database.

6. DATABASE PLATFORM AND STRUCTURE

Approximately 11,000 transplant records are stored on the database, with around 1,100 new records added each year. Data from the ABMDR-funded unrelated donor transplant collection are entered onto a separate database. Staff at the research unit are currently developing an MS Access application which will encompass both of these databases. Data from ABMTRR and ABMDR databases will be transferred to this new platform when it is developed. Currently this data is being collected under several different arrangements as listed above. However in computing terms it is efficient and appropriate to store all of it on the same database system. There should be no conflict between the various arrangements as long as the process is managed properly.

7. REPORTING

The research unit currently reports results in two ways:

1. An Annual Data Summary is produced showing activity and outcome for the most recent calendar year across Australia and New Zealand. This document is distributed to staff at all centres and other interested medical researchers and managers.

2. Submission of specific research project results to conferences and refereed journals.

It is possible in the future that NSW Health may request the equivalent of the Annual Data Summary specifically for NSW.

8. DATA AND ANALYSIS REQUESTS

The research unit receives regular requests for additional analysis of activity and outcome data, and occasionally for unit record data or analysis that would identify individual institutions. The guidelines we use are:

1. All significant requests must be referred to the ABMTRR Executive Committee for discussion.

2. Any publication using ABMTRR data should cite ABMTRR as the source.

3. The Annual Data Summary is a public document which can be distributed to researchers or other interested parties who have some understanding of medical research.

4. Small requests for additional analysis from staff at contributing transplant centres can be carried out subject to Executive Committee approval.

5. Larger requests for analysis can be carried out subject to Executive Committee approval - a charge may be levied for time spent if appropriate.

6. Any analysis that identifies single centres can only be carried out with the permission of the centres involved.

7. Normally unit records containing identifiable name fragment or date of birth fields will not be released, except to the contributing centre for verification purposes.