WHAT
The EBMT requests from all member centres that registration of
patients be done with the information contained in the minimum essential data
A (MED-A) form. The MED-A forms consist of a registration form, a series of disease
specific forms, and a follow up form. A registration MED-A consists of the registration
form and the disease-specific form which corresponds to that transplant. Registration
should be done at 100 days post-transplant or at the time of the patient's death,
whichever comes first. This includes patients who die between conditioning and
transplant. The submission of MED-A data is a requirement for a centre to be a
member of the EBMT.
In addition, the EBMT produces detailed disease specific and transplant specific
forms called MED-B. Although not
obligatory, these forms are the basis for all registry-based scientific studies
performed within the Working Parties, and the EBMT encourages all centres to fill
in MED-B forms. The MED-A data is part of the MED-B forms, therefore if MED-B
forms are submitted on registration, the MED-A form is unnecessary.
Some
national registries may have different regulations that allow registration to
be done before 100 days (for example, on leaving the isolation unit). This is
acceptable as long as: a) this happens before 100 days after transplant; and b)
an update on response, engraftment, etc. is produced when 100 days have elapsed.
WHEN
The registration of patients through MED-A should be a continuous process
throughout the year. It simplifies the work of the EBMT registries if the same
procedure is followed for the MED-B forms. However, in countries that have a national
registry that is integrated with the EBMT, a different procedure might be required
by the national registry.
The
EBMT requests follow up at yearly intervals. When exactly it will happen will
vary from centre to centre. Data checking by the EBMT is a continuous process
and proceeds all year round.
HOW
Registration involves providing the EBMT with the data contained in the MED-A
registration form and in the corresponding MED-A disease-specific form for each
transplant. Alternatively, the MED-B forms can be provided, in which case MED-A
forms need not be submitted. Submission can be done either by entering the data
directly in the EBMT database using Internet access (see ProMISe)
or by filling in the appropriate paper forms and mailing them.
Paper
forms
The data in the MED-A forms constitutes the minimal essential data
and it is obligatory for all EBMT centres to provide it.
The
EBMT assumes that centres providing MED-AB data give their consent for it to be
used in studies approved by the Working Parties.
Filling
in the forms
The MED-AB forms are available
from this site. A document with instructions
is also available and should be donwloaded the first time these forms are used.
It contains information on the forms, how to fill them in and where to send them
once they have been completed. Questions must be read carefully before completing.
Titles and subtitles provide information on when certain questions should be filled
in. If the information requested in the MED-B paper forms is unavailable, this
must be clearly stated, thus preventing the EBMT data managers from having to
ask this question again. Note that the information requested in the MED-A form
-and its equivalent in the MED-B forms- is obligatory and cannot be "unavailable".
The document MED-AB Complete
Manual, which details the meaning of individual MED-AB items, has been written
to help with the filling of these forms. If doubts appear as to how to complete
any forms, they should be addressed to the national registry or EBMT offices,
which will ensure expert advice is sought in each case. It is very important that
the people filling in these forms do point out ambiguities, lack of clarity, etc.
Any criticism can only improve the forms and the dictionary.
