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 – The PreKit-QoL study protocol

BMC Nephrology

Study Protocol

Rebecca Sberro-Soussan¹  Lionel Rostaing²  Alexandra Jobert³  Elodie Faurel-Paul³  Philippe Tessier⁴  Yohann Foucher⁴  Angélique Bonnaud-Antignac⁴  Véronique Sébille⁵  Jean-Benoit Hardouin⁵  Denis Glotz⁶  Aurélie Meurette⁷  Magali Giral⁷  Emmanuelle Papuchon⁷  Stéphanie Gentile⁸  Emmanuel Morélon⁹  Elisabeth Cassuto^1,10 

[1] Department of Nephrology and Transplantation, Hôpital Necker Assistance Publique-Hôpitaux de Paris, Université Paris Descartes Sorbonne Paris Cité, Paris, France;Department of Nephrology, Dialysis and Transplantation, Hôpital de Rangueil, Toulouse, France;Délégation à la recherche clinique et à l’innovation, CHU Nantes, Nantes, France;EA 4275 SPHERE, methodS in Patient-centered outcomes and HEalth ResEarch, Nantes University, Nantes, France;EA 4275 SPHERE, methodS in Patient-centered outcomes and HEalth ResEarch, Nantes University, Nantes, France;Biostatistics Unit, CHU Nantes, Nantes, France;Hôpital Saint Louis - Nephrology and Transplantation, Paris, France;ITUN and Inserm U1064, Nantes University, CHU Nantes, Nantes, France;Laboratoire de santé publique, SPMC EA3279, Aix-Marseille université, 13385, Marseille, France;Service de santé publique et information médicale, hôpital de la Conception, 13005, Marseille, France;Néphrologie, Transplantation et Immunologie Clinique, Hôpital Edouard Herriot, Lyon, France;Service de Néphrologie, Hôpital Pasteur, Nice, France;

关键词: Tansplantation;    Nephrology;    Preemptive;    Dialysis;    Quality of Life;    Response shift;    Item Response Theory;    Structural Equation Modeling;   

DOI  :  10.1186/s12882-016-0225-7

 received in 2015-10-25, accepted in 2016-01-12,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundTreatment 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/DesignAdult 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.DiscussionThe 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 registrationClinicalTrials.gov identifier NCT02154815, registered on May 28, 2014

【 授权许可】

CC BY   
© Sébille et al. 2016