1. Questionnaire, Database and Data transfer
Participation to the Registry is voluntary. A two-part questionnaire (Report of LT and Follow-up report) was established by the ELTR Experts Committee. The first part includes data on LT indication, donor and recipient blood group compatibility, technical aspects of LT, and the initial immunosuppression. The second part concerns the patient follow-up and contains questions on the cause of death or graft failure and the maintenance immunosuppression. To encourage completion, the questionnaire was intentionally limited to the main items. A standard database for data entry has been developed and distributed to all contributing Centers with instructions to collect accurate and uniform data. To avoid spelling and typing errors, all of the items are pull-down menus except the name of patients and the dates. A copy of updated electronic file is sent to the ELTR coordinating center every six months.
2. Data validation
A logic control program has been developed. The data are subjected to checks for completeness, consistency, and range. Comprehensive logical intra- and inter-updates are performed. A list of the inconsistencies is sent to the Center’s personnel in charge of data management each time a new update comparisons is performed. The Center performs the corrections and submits a new file. In addition, the ELTR has established agreements with the European Organ Sharing Organizations (OSO). United Kingdom Transplant Service Support Authority - UKTransplant, Spanish Organizaciòn Nacional de Transplantes - ONT, Scandinavian Scanditransplant - SKT, Dutch Transplant Foundation - NTS, Eurotransplant - ET, French Agence de la Biomédecine - ABM. The purpose of this agreement is to exchange data collected from European Centers. This collaboration represents an additional way to control the quality of the ELTR and OSO data and it does not affect the relationship established between ELTR and the individual Centers.
3. Data analysis and communication
Data are analyzed with Statistical Analysis System (SAS). The dynamics of data control are continued during the statistical analyzes. Editing and referral to clinical records are used when necessary to resolve any inconsistencies that are detected during the analysis. Most of the studies in which ELTR data is analyzed require calculation of survival rates of grafts and patients. These are determined by actuarial method and the statistical significance is determined by the Logrank test to compare survival curves. Updated results are available in this website at two localizations: Results and Documents to download.
A Center specific data analysis is done twice a year and five figures are available in the Documents to download
- Patient and graft survival
- Patient survival according to the three main indications
- Distribution of primary indications
- Patient survival according to recipient age, and
- Causes of mortality following the first LT.
These figures have been selected according to the result of a survey. This is an additional way of data quality control because certainly Centers compare these figures to their local analyses. In case a contributing center needs additional analyses, a specific data request can be submitted directly to ELTR office. Nevertheless, some guidelines have to be respected for the ELTR data use in publication or communication.
4. Experts Scientific Committee
Periodic meetings are organized by ELTR Expert Committee to review the questionnaire and to discuss topics of scientific and clinical interest. The expert Committee is composed of hepatologists and surgeons, which discuss each item of the questionnaire and validate the data entry masks and the instructions. Periodic workshops are also organized and all of the persons in charge of the updating of ELTR data (Transplant Coordinators, Data Managers, OSO representatives,) are invited to give their comments and to report problems.