Background: Treatment of end stage renal disease has an impact on patients� physical and psychological health,\nincluding quality of life (QoL). Nowadays, it is known that reducing the dialysis period has many advantages\nregarding QoL and medical outcomes. Although preemptive transplantation is the preferred strategy to prevent\npatients undergoing dialysis, its psychological impact is unknown. Moreover, transplantation can be experienced\nin a completely different manner among patients who were on dialysis and those who still had a functioning\nkidney at the time of surgery. Longitudinal data are often collected to allow analyzing the evolution of patients�\nQoL over time using questionnaires. Such data are often difficult to interpret due to the patients� changing standards,\nvalues, or conceptualization of what the questionnaire is intended to measure (e.g. QoL). This phenomenon is referred\nto as response shift and is often linked to the way the patients might adapt or cope with their disease experience.\nWhether response shift is experienced in a different way among patients who were on dialysis and those who still had\na functioning kidney at time of surgery is unknown and will be studied in the PreKit-QoL study (trial registration\nnumber: NCT02154815). Understanding the psychological impact of pre-emptive transplantation is an important\nissue since it can be associated with long-term patient and graft survival. Methods/Design: Adult patients with a pre-emptive transplantation (n = 130) will be prospectively included\nalong with a control group of patients with a pre-transplant dialysis period < 36 months (n = 260). Only first\nand single kidney transplantation will be considered. Endpoints include: comparison of change between\ngroups in QoL, anxiety and depressive disorders, perceived stress, taking into account response shift. These\ncriteria will be evaluated every 6 months prior to surgery, at hospital discharge, at three and six months, one\nand two years after transplantation.\nDiscussion: The PreKit-QoL study assesses and compares the evolution of QoL and other psychological criteria in\npreemptive and dialyzed patients taking patients� adaptation into account through response shift analyses. Our study\nmight help to conceive specific, adapted educational programs and psychological support to prevent a possible\npremature loss of the kidney as a consequence of non-compliance in patients that may be insufficiently prepared\nfor transplantation.
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