title: 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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier NCT02154815 , registered on May 28, 2014.
authors.affiliation: EA 4275 SPHERE, methodS in Patient-centered outcomes and HEalth ResEarch, Nantes University, Nantes, France. veronique.sebille@univ-nantes.fr.|Biostatistics Unit, CHU Nantes, Nantes, France. veronique.sebille@univ-nantes.fr.
authors.forename: Véronique
authors.initials: V
authors.lastname: Sébille
authors.affiliation: EA 4275 SPHERE, methodS in Patient-centered outcomes and HEalth ResEarch, Nantes University, Nantes, France. Jean-benoit.hardouin@univ-nantes.fr.|Biostatistics Unit, CHU Nantes, Nantes, France. Jean-benoit.hardouin@univ-nantes.fr.
authors.forename: Jean-Benoit
authors.initials: JB
authors.lastname: Hardouin
authors.affiliation: ITUN and Inserm U1064, Nantes University, CHU Nantes, Nantes, France. magali.giral@chu-nantes.fr.
authors.forename: Magali
authors.initials: M
authors.lastname: Giral
authors.affiliation: EA 4275 SPHERE, methodS in Patient-centered outcomes and HEalth ResEarch, Nantes University, Nantes, France. angelique.bonnaud@univ-nantes.fr.
authors.forename: Angélique
authors.initials: A
authors.lastname: Bonnaud-Antignac
authors.affiliation: EA 4275 SPHERE, methodS in Patient-centered outcomes and HEalth ResEarch, Nantes University, Nantes, France. philippe.tessier@univ-nantes.fr.
authors.forename: Philippe
authors.initials: P
authors.lastname: Tessier
authors.affiliation: ITUN and Inserm U1064, Nantes University, CHU Nantes, Nantes, France. emmanuelle.papuchon@chu-nantes.fr.
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Papuchon
authors.affiliation: Délégation à la recherche clinique et à l'innovation, CHU Nantes, Nantes, France. Alexandra.JOBERT@chu-nantes.fr.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Jobert
authors.affiliation: Délégation à la recherche clinique et à l'innovation, CHU Nantes, Nantes, France. Elodie.FAURELPAUL@chu-nantes.fr.
authors.forename: Elodie
authors.initials: E
authors.lastname: Faurel-Paul
authors.affiliation: Laboratoire de santé publique, SPMC EA3279, Aix-Marseille université, 13385, Marseille, France. stephanie.gentile@univ-amu.fr.|Service de santé publique et information médicale, hôpital de la Conception, 13005, Marseille, France. stephanie.gentile@univ-amu.fr.
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Gentile
authors.affiliation: Service de Néphrologie, Hôpital Pasteur, Nice, France. cassuto.e@chu-nice.fr.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Cassuto
authors.affiliation: Néphrologie, Transplantation et Immunologie Clinique, Hôpital Edouard Herriot, Lyon, France. emmanuel.morelon@chu-lyon.fr.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Morélon
authors.affiliation: Department of Nephrology, Dialysis and Transplantation, Hôpital de Rangueil, Toulouse, France. rostaing.l@chu-toulouse.fr.
authors.forename: Lionel
authors.initials: L
authors.lastname: Rostaing
authors.affiliation: Hôpital Saint Louis - Nephrology and Transplantation, Paris, France. denis.glotz@sls.aphp.fr.
authors.forename: Denis
authors.initials: D
authors.lastname: Glotz
authors.affiliation: Department of Nephrology and Transplantation, Hôpital Necker Assistance Publique-Hôpitaux de Paris, Université Paris Descartes Sorbonne Paris Cité, Paris, France. rebecca.sberro@nck.aphp.fr.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Sberro-Soussan
authors.affiliation: EA 4275 SPHERE, methodS in Patient-centered outcomes and HEalth ResEarch, Nantes University, Nantes, France. yohann.foucher@univ-nantes.fr.
authors.forename: Yohann
authors.initials: Y
authors.lastname: Foucher
authors.affiliation: ITUN and Inserm U1064, Nantes University, CHU Nantes, Nantes, France. aurelie.meurette@chu-nantes.fr.
authors.forename: Aurélie
authors.initials: A
authors.lastname: Meurette
mesh_terms: D000223:Adaptation, Psychological; D000328:Adult; D006801:Humans; D007676:Kidney Failure, Chronic / Q000517:prevention & control / Q000628:therapy; D016030:Kidney Transplantation / Q000523:psychology*; D065286:Prophylactic Surgical Procedures / Q000523:psychology*; D011446:Prospective Studies; D011788:Quality of Life / Q000523:psychology*; D006435:Renal Dialysis / Q000523:psychology*; D051436:Renal Insufficiency, Chronic / Q000601:surgery*; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult