The STCS is a prospective multicenter cohort which was designed as a dynamic cohort study where SOT recipients move in and out as time progresses [12 ]. We define prospective in the sense that data definitions were made in agreement with the rationale of the study prior to the enrolment period, and that measurements are made in agreement with these definitions [13 ]. A version control strategy has been implemented that ensures data consistency over time, should changes or an updating of the data definitions become necessary.
A patient is considered as transplanted and therefore enrolled at the moment of transplantation, i.e. when the surgeon releases the clamps to start reperfusion of the allograft. For islets transplantation, we defined transplantation as the moment when the islets are injected into the recipient. At the time point of transplantation, the “patient clock” is set to zero initiating prospective follow-up of both the patient and the corresponding allograft(s). Any subsequent transplantation that may occur for a patient is prospectively registered within the patient-case system. Patient follow-up ends with death or definitive drop-out. Non-fatal graft failure does not truncate a patient’s follow-up (e.g. kidney transplant recipients).
A patient is considered as transplanted and therefore enrolled at the moment of transplantation, i.e. when the surgeon releases the clamps to start reperfusion of the allograft. For islets transplantation, we defined transplantation as the moment when the islets are injected into the recipient. At the time point of transplantation, the “patient clock” is set to zero initiating prospective follow-up of both the patient and the corresponding allograft(s). Any subsequent transplantation that may occur for a patient is prospectively registered within the patient-case system. Patient follow-up ends with death or definitive drop-out. Non-fatal graft failure does not truncate a patient’s follow-up (e.g. kidney transplant recipients).
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