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
Identifieur interne : 000578 ( Main/Exploration ); précédent : 000577; suivant : 000579Prospective, 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
Auteurs : Véronique Sébille [France] ; Jean-Benoit Hardouin [France] ; Magali Giral [France] ; Angélique Bonnaud-Antignac [France] ; Philippe Tessier [France] ; Emmanuelle Papuchon [France] ; Alexandra Jobert [France] ; Elodie Faurel-Paul [France] ; Stéphanie Gentile [France] ; Elisabeth Cassuto [France] ; Emmanuel Morélon [France] ; Lionel Rostaing [France] ; Denis Glotz [France] ; Rebecca Sberro-Soussan [France] ; Yohann Foucher [France] ; Aurélie Meurette [France]Source :
- BMC Nephrology [ 1471-2369 ] ; 2016.
Abstract
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.
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.
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.
ClinicalTrials.gov identifier
Url:
DOI: 10.1186/s12882-016-0225-7
PubMed: 26785745
PubMed Central: 4719683
Affiliations:
- France
- Auvergne-Rhône-Alpes, Midi-Pyrénées, Occitanie (région administrative), Pays de la Loire, Provence-Alpes-Côte d'Azur, Rhône-Alpes, Île-de-France
- Lyon, Marseille, Nantes, Nice, Paris, Toulouse
- Université d'Aix-Marseille
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Le document en format XML
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methodS in Patient-centered outcomes and HEalth ResEarch, Nantes University, Nantes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>EA 4275 SPHERE, methodS in Patient-centered outcomes and HEalth ResEarch, Nantes University, Nantes</wicri:regionArea><placeName><region type="region">Pays de la Loire</region><region type="old region">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation><affiliation wicri:level="3"><nlm:aff id="Aff2">Biostatistics Unit, CHU Nantes, Nantes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Biostatistics Unit, CHU Nantes, Nantes</wicri:regionArea><placeName><region type="region">Pays de la Loire</region><region type="old region">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation></author><author><name sortKey="Hardouin, Jean Benoit" sort="Hardouin, Jean Benoit" uniqKey="Hardouin J" first="Jean-Benoit" last="Hardouin">Jean-Benoit Hardouin</name><affiliation wicri:level="3"><nlm:aff id="Aff1">EA 4275 SPHERE, methodS in Patient-centered outcomes and HEalth ResEarch, Nantes University, Nantes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>EA 4275 SPHERE, methodS in Patient-centered outcomes and HEalth ResEarch, Nantes University, Nantes</wicri:regionArea><placeName><region type="region">Pays de la Loire</region><region type="old region">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation><affiliation wicri:level="3"><nlm:aff id="Aff2">Biostatistics Unit, CHU Nantes, Nantes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Biostatistics Unit, CHU Nantes, Nantes</wicri:regionArea><placeName><region type="region">Pays de la Loire</region><region type="old region">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation></author><author><name sortKey="Giral, 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de santé publique, SPMC EA3279, Aix-Marseille université, 13385 Marseille, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Laboratoire de santé publique, SPMC EA3279, Aix-Marseille université, 13385 Marseille</wicri:regionArea><wicri:noRegion>13385 Marseille</wicri:noRegion><placeName><settlement type="city">Marseille</settlement><region type="région" nuts="2">Provence-Alpes-Côte d'Azur</region><settlement type="city">Marseille</settlement></placeName><orgName type="university">Université d'Aix-Marseille</orgName></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff6">Service de santé publique et information médicale, hôpital de la Conception, 13005 Marseille, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Service de santé publique et information médicale, hôpital de la Conception, 13005 Marseille</wicri:regionArea><wicri:noRegion>13005 Marseille</wicri:noRegion><placeName><settlement type="city">Marseille</settlement><region type="région" nuts="2">Provence-Alpes-Côte d'Azur</region></placeName></affiliation></author><author><name sortKey="Cassuto, Elisabeth" sort="Cassuto, Elisabeth" uniqKey="Cassuto E" first="Elisabeth" last="Cassuto">Elisabeth Cassuto</name><affiliation wicri:level="3"><nlm:aff id="Aff7">Service de Néphrologie, Hôpital Pasteur, Nice, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Service de Néphrologie, Hôpital Pasteur, Nice</wicri:regionArea><placeName><region type="region">Provence-Alpes-Côte d'Azur</region><region type="old region">Provence-Alpes-Côte d'Azur</region><settlement type="city">Nice</settlement></placeName></affiliation></author><author><name sortKey="Morelon, Emmanuel" sort="Morelon, Emmanuel" uniqKey="Morelon E" first="Emmanuel" last="Morélon">Emmanuel Morélon</name><affiliation wicri:level="3"><nlm:aff id="Aff8">Néphrologie, Transplantation et Immunologie Clinique, Hôpital Edouard Herriot, Lyon, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Néphrologie, Transplantation et Immunologie Clinique, Hôpital Edouard Herriot, Lyon</wicri:regionArea><placeName><region type="region">Auvergne-Rhône-Alpes</region><region type="old region">Rhône-Alpes</region><settlement type="city">Lyon</settlement></placeName></affiliation></author><author><name sortKey="Rostaing, Lionel" sort="Rostaing, Lionel" uniqKey="Rostaing L" first="Lionel" last="Rostaing">Lionel Rostaing</name><affiliation wicri:level="3"><nlm:aff id="Aff9">Department of Nephrology, Dialysis and Transplantation, Hôpital de Rangueil, Toulouse, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Department of Nephrology, Dialysis and Transplantation, Hôpital de Rangueil, Toulouse</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Glotz, Denis" sort="Glotz, Denis" uniqKey="Glotz D" first="Denis" last="Glotz">Denis Glotz</name><affiliation wicri:level="3"><nlm:aff id="Aff10">Hôpital Saint Louis - Nephrology and Transplantation, Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Hôpital Saint Louis - Nephrology and Transplantation, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Sberro Soussan, Rebecca" sort="Sberro Soussan, Rebecca" uniqKey="Sberro Soussan R" first="Rebecca" last="Sberro-Soussan">Rebecca Sberro-Soussan</name><affiliation wicri:level="3"><nlm:aff id="Aff11">Department of Nephrology and Transplantation, Hôpital Necker Assistance Publique-Hôpitaux de Paris, Université Paris Descartes Sorbonne Paris Cité, Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Department of Nephrology and Transplantation, Hôpital Necker Assistance Publique-Hôpitaux de Paris, Université Paris Descartes Sorbonne Paris Cité, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Foucher, Yohann" sort="Foucher, Yohann" uniqKey="Foucher Y" first="Yohann" last="Foucher">Yohann Foucher</name><affiliation wicri:level="3"><nlm:aff id="Aff1">EA 4275 SPHERE, methodS in Patient-centered outcomes and HEalth ResEarch, Nantes University, Nantes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>EA 4275 SPHERE, methodS in Patient-centered outcomes and HEalth ResEarch, Nantes University, Nantes</wicri:regionArea><placeName><region type="region">Pays de la Loire</region><region type="old region">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation></author><author><name sortKey="Meurette, Aurelie" sort="Meurette, Aurelie" uniqKey="Meurette A" first="Aurélie" last="Meurette">Aurélie Meurette</name><affiliation wicri:level="3"><nlm:aff id="Aff3">ITUN and Inserm U1064, Nantes University, CHU Nantes, Nantes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>ITUN and Inserm U1064, Nantes University, CHU Nantes, Nantes</wicri:regionArea><placeName><region type="region">Pays de la Loire</region><region type="old region">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation></author></analytic><series><title level="j">BMC Nephrology</title><idno type="eISSN">1471-2369</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>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.</p></sec><sec><title>Methods/Design</title><p>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.</p></sec><sec><title>Discussion</title><p>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.</p></sec><sec><title>Trial registration</title><p>ClinicalTrials.gov identifier <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT02154815">NCT02154815</ext-link>, registered on May 28, 2014</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Knoll, G" uniqKey="Knoll G">G Knoll</name></author><author><name sortKey="Cockfield, S" uniqKey="Cockfield S">S Cockfield</name></author><author><name sortKey="Blydt Hansen, T" uniqKey="Blydt Hansen T">T Blydt-Hansen</name></author><author><name sortKey="Baran, D" uniqKey="Baran D">D Baran</name></author><author><name sortKey="Kiberd, B" uniqKey="Kiberd B">B Kiberd</name></author><author><name 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sortKey="Conroy, R" uniqKey="Conroy R">R Conroy</name></author><author><name sortKey="Sebille, V" uniqKey="Sebille V">V Sebille</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Sebille, V" uniqKey="Sebille V">V Sebille</name></author><author><name sortKey="Hardouin, Jb" uniqKey="Hardouin J">JB Hardouin</name></author><author><name sortKey="Mesbah, M" uniqKey="Mesbah M">M Mesbah</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Thomas, Ml" uniqKey="Thomas M">ML Thomas</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>France</li></country><region><li>Auvergne-Rhône-Alpes</li><li>Midi-Pyrénées</li><li>Occitanie (région administrative)</li><li>Pays de la Loire</li><li>Provence-Alpes-Côte d'Azur</li><li>Rhône-Alpes</li><li>Île-de-France</li></region><settlement><li>Lyon</li><li>Marseille</li><li>Nantes</li><li>Nice</li><li>Paris</li><li>Toulouse</li></settlement><orgName><li>Université d'Aix-Marseille</li></orgName></list><tree><country name="France"><region name="Pays de la Loire"><name sortKey="Sebille, Veronique" sort="Sebille, Veronique" uniqKey="Sebille V" first="Véronique" last="Sébille">Véronique Sébille</name></region><name sortKey="Bonnaud Antignac, Angelique" sort="Bonnaud Antignac, Angelique" uniqKey="Bonnaud Antignac A" first="Angélique" last="Bonnaud-Antignac">Angélique Bonnaud-Antignac</name><name sortKey="Cassuto, Elisabeth" sort="Cassuto, Elisabeth" uniqKey="Cassuto E" first="Elisabeth" last="Cassuto">Elisabeth Cassuto</name><name sortKey="Faurel Paul, Elodie" sort="Faurel Paul, Elodie" uniqKey="Faurel Paul E" first="Elodie" last="Faurel-Paul">Elodie Faurel-Paul</name><name sortKey="Foucher, Yohann" sort="Foucher, Yohann" uniqKey="Foucher Y" first="Yohann" last="Foucher">Yohann Foucher</name><name sortKey="Gentile, Stephanie" sort="Gentile, Stephanie" uniqKey="Gentile S" first="Stéphanie" last="Gentile">Stéphanie Gentile</name><name sortKey="Gentile, Stephanie" sort="Gentile, Stephanie" uniqKey="Gentile S" first="Stéphanie" last="Gentile">Stéphanie Gentile</name><name sortKey="Giral, Magali" sort="Giral, Magali" uniqKey="Giral M" first="Magali" last="Giral">Magali Giral</name><name sortKey="Glotz, Denis" sort="Glotz, Denis" uniqKey="Glotz D" first="Denis" last="Glotz">Denis Glotz</name><name sortKey="Hardouin, Jean Benoit" sort="Hardouin, Jean Benoit" uniqKey="Hardouin J" first="Jean-Benoit" last="Hardouin">Jean-Benoit Hardouin</name><name sortKey="Hardouin, Jean Benoit" sort="Hardouin, Jean Benoit" uniqKey="Hardouin J" first="Jean-Benoit" last="Hardouin">Jean-Benoit Hardouin</name><name sortKey="Jobert, Alexandra" sort="Jobert, Alexandra" uniqKey="Jobert A" first="Alexandra" last="Jobert">Alexandra Jobert</name><name sortKey="Meurette, Aurelie" sort="Meurette, Aurelie" uniqKey="Meurette A" first="Aurélie" last="Meurette">Aurélie Meurette</name><name sortKey="Morelon, Emmanuel" sort="Morelon, Emmanuel" uniqKey="Morelon E" first="Emmanuel" last="Morélon">Emmanuel Morélon</name><name sortKey="Papuchon, Emmanuelle" sort="Papuchon, Emmanuelle" uniqKey="Papuchon E" first="Emmanuelle" last="Papuchon">Emmanuelle Papuchon</name><name sortKey="Rostaing, Lionel" sort="Rostaing, Lionel" uniqKey="Rostaing L" first="Lionel" last="Rostaing">Lionel Rostaing</name><name sortKey="Sberro Soussan, Rebecca" sort="Sberro Soussan, Rebecca" uniqKey="Sberro Soussan R" first="Rebecca" last="Sberro-Soussan">Rebecca Sberro-Soussan</name><name sortKey="Sebille, Veronique" sort="Sebille, Veronique" uniqKey="Sebille V" first="Véronique" last="Sébille">Véronique Sébille</name><name sortKey="Tessier, Philippe" sort="Tessier, Philippe" uniqKey="Tessier P" first="Philippe" last="Tessier">Philippe Tessier</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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