Registry Working Party
The 3 levels: datasets and driving questions
This section contains a description of the three Levels and (technical) documents on the ESID Registry; in particular, the complete Level 1 dataset with field definitions and driving questions as well as the Level 2 dataset ( unPAD study).
Slides and flow charts describing the documentation process in the ESID Registry
Oct 18, 2013
- Level 1 is mandatory for each patient.
- All parts of Level 1 must be completed.
- At initial registration (“baseline”), there are sections on diagnosis, HSCT and Ig replacement that need to be completed.
- At follow-up, the system asks for a status update and for changes in therapy. If the patient has died, or the diagnosis has changed, details on these changes can be documented.
- The system will ask you to update your patients at least once a year. If you miss to update some patients, the system will automatically send a reminder one year after the last respective documentation date with a list of the ESID-IDs of these patients.
Level 1 Datasets:
Corresponding questionnaires are provided that can be applied to patients and physicians to collect the necessary data items for the new ESID Registry.
Updated versions, Sep 22, 2014
Level 1 Driving Questions:
These are the driving research questions underlying these datasets:
- At level 2 we ask for lab values, detailed clinical features and more details on treatments (on top of Ig replacement, immune modifying treatment and HSCT).
- The level 2 data models can be category specific, disease specific, or disease group specific (e.g. UnPad, GAIN).
- Level 2 is optional. If you do not have the resources, you will not have to work on level 2 at all. Depending on your research interests or the type of patients you attend, you can also choose to document level 2 for selected categories or even selected patients only.
Level 2 Datasets:
These are the datasets for level 2 documentation which is optional.
Currently the dataset for the UnPAD Study is available.
Updated version, Okt 28, 2016
Please refer to the registry studies section for further information on the unPAD study.
- In addition, there are dedicated studies on level 3. These shall have a fixed time frame (e.g. four years) and address specific questions defined by a study protocol, including a statistical evaluation plan and a „feasibility assessment“. Level 3 studies can be extended (e.g. to increase the recruiting rate).