8 Strengths and Limitations of the analysis

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In the present investigation, we were able to access the progress of the ESP to date by studying the unique cohort of ESP patients transplanted from the beginning of the program in 1999 up to 2004. We successfully collected additional information over and above the Eurotransplant database on 85% of the ESP patients and on two control groups, observed over the same time period as the ESP patients, and matching the ESP patients for donor age (Control 1) and recipient age (Control 2). The analysis consisted of 3400 patients, with a time of documented follow up comparable in all 3 groups indicating that there was no systematic error in the data capture and providing confidence about the robustness of the results.

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Although the ESP prospectively allocates old donor organs to old recipients, it should be noted that this analysis is based mainly on data collected retrospectively. Certain information, in particular the long term data that was newly captured for this 5-year analysis was therefore only available for the “updated patient group”, i.e. 85% of patients. Verification of Source data was only performed in selected cases and thus the number of outliers in the database is relatively high. Due to the nature of the program and the inclusion of ESP into ETKAS as of 2001 no perfect Control group could be defined. Control 1 differed in terms of recipient age, Control 2 differed in both recipient and donor age from the study group. Creatinine Clearance was calculated using the Cockroft-Gault Formula using baseline demographic data for weight, height and gender at time of transplantation. This limitation should be considered when interpreting the results. ESP does not restrict centres from transplanting patients with certain co-morbidity patterns or special pre-renal interventions, thus pre-transplant clinical condition accepted for transplantation within ESP may vary from centre to centre. The same applies to the donor. The ESP program does not restrict or stratify donor organs by co-morbidities such as diabetes or hypertension that are known to impact the quality of the organ and the graft function. Centre-specific differences are already apparent when looking at the single centre results published to date. Differences in cold ischemic times, acute rejection rates, graft and patient survival rate have been reported. We did not account for these centre-specific differences in this analysis.


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