NDLI: Prospective, multicenter, controlled study of quality of life, psychological adjustment process and medical outcomes of patients receiving a preemptive kidney transplant compared to a similar population of recipients after a dialysis period of less than three years

Content Provider	Springer Nature : BioMed Central
Author	Sébille, Véronique Hardouin, Jean-Benoit Giral, Magali Bonnaud-Antignac, Angélique Tessier, Philippe Papuchon, Emmanuelle Jobert, Alexandra Faurel-Paul, Elodie Gentile, Stéphanie Cassuto, Elisabeth Morélon, Emmanuel Rostaing, Lionel Glotz, Denis Sberro-Soussan, Rebecca Foucher, Yohann Meurette, Aurélie
Abstract	Background Treatment of end stage renal disease has an impact on patients’ physical and psychological health, including quality of life (QoL). Nowadays, it is known that reducing the dialysis period has many advantages regarding QoL and medical outcomes. Although preemptive transplantation is the preferred strategy to prevent patients undergoing dialysis, its psychological impact is unknown. Moreover, transplantation can be experienced in a completely different manner among patients who were on dialysis and those who still had a functioning kidney at the time of surgery. Longitudinal data are often collected to allow analyzing the evolution of patients’ QoL over time using questionnaires. Such data are often difficult to interpret due to the patients’ changing standards, values, or conceptualization of what the questionnaire is intended to measure (e.g. QoL). This phenomenon is referred to as response shift and is often linked to the way the patients might adapt or cope with their disease experience. Whether response shift is experienced in a different way among patients who were on dialysis and those who still had a functioning kidney at time of surgery is unknown and will be studied in the PreKit-QoL study (trial registration number: NCT02154815). Understanding the psychological impact of pre-emptive transplantation is an important issue 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 along with a control group of patients with a pre-transplant dialysis period < 36 months (n = 260). Only first and single kidney transplantation will be considered. Endpoints include: comparison of change between groups in QoL, anxiety and depressive disorders, perceived stress, taking into account response shift. These criteria will be evaluated every 6 months prior to surgery, at hospital discharge, at three and six months, one and two years after transplantation. Discussion The PreKit-QoL study assesses and compares the evolution of QoL and other psychological criteria in preemptive and dialyzed patients taking patients’ adaptation into account through response shift analyses. Our study might help to conceive specific, adapted educational programs and psychological support to prevent a possible premature loss of the kidney as a consequence of non-compliance in patients that may be insufficiently prepared for transplantation. Trial registration ClinicalTrials.gov identifier NCT02154815 , registered on May 28, 2014
Related Links	https://bmcnephrol.biomedcentral.com/counter/pdf/10.1186/s12882-016-0225-7.pdf
Ending Page	9
Page Count	9
Starting Page	1
File Format	HTM / HTML
ISSN	14712369
DOI	10.1186/s12882-016-0225-7
Journal	BMC Nephrology
Issue Number	1
Volume Number	17
Language	English
Publisher	BioMed Central
Publisher Date	2016-01-19
Access Restriction	Open
Subject Keyword	Nephrology Internal Medicine Tansplantation Preemptive Dialysis Quality of Life Response shift Item Response Theory Structural Equation Modeling
Content Type	Text
Resource Type	Article
Subject	Nephrology
Journal Impact Factor	2.2/2023
5-Year Journal Impact Factor	2.6/2023

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