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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 dialysis

Auteurs

• Sébille Véronique - PU-PH Biostatistique - Directrice de l'unité SPHERE  - Université de Nantes - UFR de Pharmacie 
  
  
• Hardouin Jean-Benoit - Maitre de Conférences - HDR - Biostatistique  - UFR de Pharmacie 
  
  
• Giral Magali - PU-PH  - CHU de Nantes  
  
  
• Bonnaud-Antignac Angélique - Professeur des Universités - Responsable de l'Unité Fonctionnelle de Psycho-Oncologie de l'Institut de Cancérologie de l'Ouest Centre René Gauducheau  - UFR de Médecine - Université de Nantes et Institut de Cancérologie de l'Ouest (ICO) 
  
  
• Tessier Philippe - Maître de Conférences en Economie de la Santé  - Université de Nantes - UFR de Médecine 
  
  
• Papuchon Emmanuelle
  
  
• Jobert A
  
  
• Faurel-Paul E
  
  
• Gentile S
  
  
• Cassuto R
  
  
• Morelon E
  
  
• Rostaing L
  
  
• Glotz D
  
  
• Sberro-Soussan R
  
  
• Foucher Yohann - Maître de Conférences en Biostatistique - HDR  - UFR de médecine - Université de Nantes 
  
  
• Meurette Aurélie
  
  

Description

Nature : Articles dans une revue internationale
Thématique : Biostatistique et Mesures Subjectives en Santé
Rang : Rang A : publication porté par un membre de l'unité, dans le cadre de l'unité
Axe de recherche principal: Méthodologie pour les Mesures Subjectives en Santé

Sébille V, Hardouin JB, Giral M, Bonnaud-Antignac A, Tessier P, Papuchon E, Jobert A, Faurel-Paul E, Gentile S, Cassuto R, Morelon E, Rostaing L, Glotz D, Sberro-Soussan R, Foucher Y, Meurette A (2016) 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 dialysis. BMC Nephrol, 17(1): 11.

Lien

Résumé

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.

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.

Publications ayant le même axe principal de recherche (Méthodologie pour les Mesures Subjectives en Santé)

• Sautenet B, Tong A, Chapman J, Warrens A, Rosenbloom D, Wong G, Gill J, Budde K, Marson L, Josephson M, Reese P, Evangelidis N, Craig J (2018) Range and consistency of outcomes reported in randomized trials conducted in kidney transplant recipients: a systematic review. Transplantation, 102(12): 2065-71.
  
  
• Ju A, Josephson M, Burucoa C, Joyeux-Faure M, Tandé D, Tawa A, Fournier G, Do-Pham G, Casey R, Jézéquel P, Lochon B, Knoll G, Ahn C, Hanson C, Sautenet B, Manera K, Craig J, Howell M, Rusch E, Tong A, SONG-Tx Lige Participation Workshop Investigators (2018)
  
  
• Ju A, Josephson M, Butt Z, Jowsey-Gregoire S, Tan J, Taylor Q, Fowler K, Dobbels F, Caskey F, Jha V, Locke J, Knoll G, Ahn C, Hanson C, Sautenet B, Manera K, Craig J, Howell M, Rutherford C, Tong A, SONG-Tx Lige Participation Workshop Investigators (2018) Establishing a Core Outcome Measure for Life Participation: a Standardized Outcomes in Nephrology - Kidney Transplantation (SONG-Tx) Consensus Workshop Report. Transplantation: doi: 10.1097/TP.0000000000002476. [Epub ahead of print].
  
  
• Dibao-Dina C, Angoulvant D, Lebeau JP, Peurois J, Abdallah El Hirtsi K, Lehr-Drylewicz AM (2018) Patients' adherence to optimal therapeutic, lifestyle and risk factors recommendations after myocardial infarction: Six years follow-up in primary care. PloS One, 13(9): e0202986. doi: 10.1371/journal.pone.0202986. eCollection 2018.
  
  
• O'Lone E, Viecelli A, Craig J, Tong A, Sautenet B, Roy D, Herrington W, Herzog C, Jafar T, Jardine M, Krane V, Levin A, Malyszko J, Rocco M, Strippoli G, Tonelli M, Wang A, Wanner C, Zannad F, Winkelmayer W, Webster AC, Wheeler DC (2018) Cardiovascular Outcomes Reported in Hemodialysis Trials. J Am Coll Cardiol, 71(24): 2802-10.
  
  
• (Soumis) Blanchin M, Guilleux A, Hardouin JB, Sébille V (2017) Searching for an optimal SEM-based method to assess response shift at item level: a simulation study.
  
  
• Hamel JF, Sébille V, Le Neel T, Kubis G, Boyer F, Hardouin JB (2017) What are the appropriate methods for analyzing patients reported outcomes in randomized trials when data are missing?. Statistical Methods in Medical Research, 26(6): 2897-2908.
  
  
• Salmon M, Blanchin M, Rotonda C, Guillemin F, Sébille V (2017) Identifying patterns of adaptation in breast cancer patients with cancer-related fatigue using response shift analyses at subgroup level. Cancer Medicine, 6(11): 2562-2575.
  
  
• Denis F, Bizien P, Tubert-Jeanin S, Hamad M, Trojak B, Rude N, Hardouin JB (2017) A Rasch analysis between schizophrenic patients and the general population. Behavioral neuroscience, 8: 139-146.
  
  
• Vanier A, Falissard B, Sébille V, Hardouin JB (2017) The complexity of interpreting changes observed over time in Health-Related Quality of Life: a short overview of 15 years of research on response shift theory. In Guillemin F, Leplège A, Briançon S, Spitz E, Coste J. Perceived health and adaptation in chronic disease. Stakes and future challenge (Taylor and Francis): 202-230.
  
  
• Lamirault G, de Bock E, Sébille V, Delasalle B, Roncalli J, Susen S, Piot C, Trochu JN, Teiger E, Neuder Y, Le Tourneau T, Manrique A, Hardouin JB, Lemarchand P (2017) Sustained quality of life improvement after intracoronary injection of autologous bone marrow cells in the setting of acute myocardial infarction: results from the BONAMI trial. Quality of Life Research, 26(1): 121-125.
  
  
• Tessier P, Blanchin M, Sébille V (2017) Does the relationship between health-related quality of life and subjective well-being change over time? An exploratory study among breast cancer patients. Social Science & Medicine, 174: 96-103.
  
  
• de Bock E, Hardouin JB, Blanchin M, Le Neel T, Kubis G, Dantan E, Bonnaud-Antignac A, Sébille V (2016) Rasch-family models are more valuable than score-based approaches for analysing longitudinal PRO with intermittent missing data. Statistical Methods in Medical Research , 25(5): 2067–2087.
  
  
• Vanier A (2016) Thèse de science biostatistique - Université de Nantes. The concept, measurement and integration of response shift phenomenon in Patient-Reported Outcomes data analyses. On certain methodological and statistical considerations. , 174 pages.
  
  
• (Soumis) Blanchin M, Hardouin JB, Le Neel T, Kubis G, Sébille V (2016) CTT and Rasch-based approaches for joint analysis of group and time effects of longitudinal Patient Reported Outcomes: impact of dropout mechanisms..
  
  
• Rouquette A, Côté SM, Hardouin JB, Falissard B (2016) Rasch modelling to deal with changes in the questionnaires used during long-term follow-up of cohort studies: a simulation study.. BMC Med Res Methodol, 16(1): 105.
  
  
• Hamel JF, Sébille V, Challet G, Hardouin JB (2016) Partial Credit Model: estimations and tests of fit with pcmodel. Stata Journal, 16(2): 464-481.
  
  
• Blanchin M, Sébille V, Guilleux A, Hardouin JB (2016) The Guttman errors as a tool for response shift detection at subgroup and item levels. Quality of Life Research, 25(6): 1385-1393.
  
  
• Guillou-Landreat M, Guilleux A, Sauvaget A, Brisson L, Leboucher J, Remaud M, Challet G, Grall-Bronnec M (2016) Factors associated with suicidal risk among a French cohort of problem gamblers seeking treatment. Psychiatry Research, 240: 11-18.
  
  
• Sauvaget A, Trojak B, Bulteau S, Jiménez-Murcia S, Fernández-Aranda F, Wolz I, Menchón JM, Achab S, Vanelle J, Grall-Bronnec M (2015) Transcranial direct current stimulation (tDCS) in behavioral and food addiction: a systematic review of efficacy, technical, and methodological issues. Front Neurosci, 9: 349.
  
  
• Feddag ML, Sébille V, Blanchin M, Hardouin JB (2015) Estimation of parameters of the Rasch model and comparison of groups in presence of locally dependent items. Journal of Applied Measurement, 16(3): 268-77.
  
  
• Vanier A, Sébille V, Blanchin M, Guilleux A, Hardouin JB (2015) Overall performance of Oort's procedure for response shift detection at item-level: a pilot simulation study. Quality of life research, 24(8): 1799-807.
  
  
• Hardouin JB, Blanchin M, Feddag ML, Le Neel T, Perrot B, Sébille V (2015) Power and sample size determination for group comparison on Patient Reported Outcomes using polytomous Rasch models. Statistics in Medicine, 34(16): 2444-55.
  
  
• Vanier A, Leplège A, Hardouin JB, Sébille V, Falissard B (2015) Semantic primes theory may be helpful in designing questionnaires such as to prevent response shift. Journal of Clinical Epidemiology, 68(6): 646-654.
  
  
• Feuillet F, Bellanger L, Hardouin JB, Victorri-Vigneau C, Sébille V (2015) On comparison of clustering methods for pharmacoepidemiological data. Journal of Biopharmaceutical Statistics, 25(4): 843-856.
  
  
• Blanchin M, Guilleux A, Perrot B, Bonnaud-Antignac A, Hardouin JB, Sébille V (2015) Power and sample size determination for the group comparison of patient-reported outcomes using the Rasch model: impact of a misspecification of the parameters. BMC Medical Research Methodology, 15: 21.
  
  
• Guilleux A, Blanchin M, Vanier A, Guillemin F, Falissard B, Schwartz C, Hardouin JB, Sébille V (2015) RespOnse Shift ALgorithm in Item response theory (ROSALI) for response shift detection with missing data in longitudinal patient-reported outcome studies. Quality of life research, 24(3): 553-564.
  
  
• de Bock E, Hardouin JB, Blanchin M, Le Neel T, Kubis G, Sébille V (2015) Assessment of score and Rasch-based methods for group comparison of longitudinal Patient-Reported Outcomes with intermittent missing data (informative and non-informative). Quality of Life Research, 24(1): 19-29.
  
  
• Anthoine E, Moret L, Regnault A, Sébille V, Hardouin JB (2014) Sample size used to validate a scale: a review of publications on newly-developed patient reported outcomes measures. Health and Quality of Life Outcomes, 12: 176.
  
  
• Feddag ML, Blanchin M, Hardouin JB, Sébille V (2014) Power analysis on the time effect for the longitudinal Rasch model. Journal of Applied Measurement, 15(3): 292-301.
  
  
• Sébille V, Blanchin M, Guillemin F, Falissard B, Hardouin JB (2014) A simple ratio-based approach for power and sample size determination for Rasch analysis. BMC Medical Research Methodology, 14(1): 87.
  
  
• Rouquette A, Blanchin M, Sébille V, Guillemin F, Côté SM, Falissard B, Hardouin JB (2014) Determination of the Minimal Clinically Important Difference using Item Response Theory Models: an attempt to solve the issue of the association with baseline score. Journal of Clinical Epidemiology, 64(4): 433-440.
  
  
• Boyer L, Baumstarck K, Michel P, Boucekine M, Anota A, Bonnetain F, Coste J, Falissard B, Guilleux A, Hardouin JB, Loundou A, Mercier M, Mesbah M, Rouquette A, Sébille V, Verdam M, Ghattas B, Guillemin F, Auquier P (2014) Statistical challenges in quality of life and cancer: New avenues for future researches. Expert Review of Pharmacoeconomics & Outcomes Research, 14(1): 19-22.
  
  
• Guilleux A, Blanchin M, Hardouin JB, Sébille V (2014) Power and sample size determination in the Rasch model: Evaluation of the robustness of a numerical method to non-normality of the latent trait. Plos One, 9(1): e0083652.
  
  
• Schwartz C, Sajobi T, Verdam M, Sébille V, Lix L, Guilleux A, Sprangers M (2014) Method variation in the impact of missing data on response shift detection. Quality of Life Research : .
  
  
• Blanchin M, Hardouin JB, Guillemin F, Falissard B, Sébille V (2013) Power and sample size determination for the group comparison of patient-reported outcomes with Rasch family models. PLoS ONE, 8(2): e57279.
  
  
• Hamel JF, Hardouin JB, Le Neel T, Kubis G, Roquelaure Y, Sébille V (2012) Study of different methods for comparing groups by analysis of subjective health measurements. PLoS One, 7(10): e44695.
  
  
• Hardouin JB (2012) Validation, Planification et Analyse d’échelles de mesure de concepts latents dans le domaine de la santé. Habilitation à Diriger les Recherches, Ecole doctorale Biologie Santé, 117 pages.
  
  
• Hardouin JB, Amri S, Feddag ML, Sébille V (2012) Towards Power And Sample Size Calculations For Item Response Theory Analysis For The Comparison Of Two Groups Of Patients. Statistics in Medicine, 31(11): 1277-1290.
  
  
• Feddag ML, Hardouin JB, Sébille V (2012) Pairwise- and marginal-likelihood estimation for the mixed Rasch model with binary data . Journal of Statistical Computation and Simulation , 82(3): 419-430.
  
  
• Hardouin JB, Conroy R, Sébille V (2011) Imputation by the mean score should be avoided when validating a Patient Reported Outcomes questionnaire by a Rasch model in presence of informative missing data. BMC Medical Research Methodology, 11(105): 1-13.
  
  
• Blanchin M (2011) Comparaison des approches CTT et IRT pour l'analyse des effets temps et groupe de données longitudinales de type Patient-Reported Outcomes et impact du dropout. Thèse de doctorat de l'Université de Nantes - Ecole doctorale Biologie Santé, 219 pages.
  
  
• Blanchin M, Hardouin JB, Le Neel T, Kubis G, Blanchard C, Mirallié E, Sébille V (2011) Comparison of CTT and IRT based-approach for the analysis of longitudinal Patient Reported Outcome . Statistics in Medicine, 30(8): 825-838.
  
  
• Hardouin JB, Bonnaud-Antignac A, Sébille V (2011) Non parametric Item Response Theory using Stata. The Stata Journal, 11(1): 30-51.
  
  
• Blanchin M, Hardouin JB, Le Neel T, Kubis G, Sébille V (2011) Analysis of longitudinal Patient-Reported Outcomes with informative and non-informative dropout: Comparison of CTT and Rasch-based methods. International Journal of Applied Mathematics & Statistics (IJAMAS), 24: SI-11A.
  
  
• Sébille V, Hardouin JB, Le Neel T, Kubis G, Boyer F, Guillemin F, Falissard B (2010) Methodological issues regarding power of Classical Test Theory (CTT) and Item Response Theory (IRT)-based approaches for the comparison of Patient-Reported Outcomes in two groups of patients - A simulation study. BMC Medical Research Methodology, 10: 24.
  
  
• Sébille V, Hardouin JB (2008) Sequential Analysis of Quality of Life Measurements using Mixed Rasch Models. In Statistical models and methods for biomedical and technical systems (Vonta F, Nikulin M, Limnios N, Huber C (eds.)): Birkhäuser: Boston. Chapter 24: 333-338.
  
  
• Hardouin JB, Mesbah M (2008) Selection of items fitting a Rasch model. In Mathematical methods for survival analysis, reliability and Quality of life (Eds Huber C., Limnios N., Mesbah M., Nikulin M.): Hermes: Paris. Chapter 17: 255-274..
  
  
• Sébille V, Hardouin JB, Mesbah M (2007) Sequential analysis of latent variables using mixed-effect latent variable models: impact of non-informative and informative missing data. Statistics in Medicine, 26(27): 4889-4904.
  
  
• Hardouin JB, Mesbah M (2007) The SAS macro-program %AnaQol to estimate the parameters of IRT models. Communications in Statistics – Simulation and Computation, 36(2): 437-453.
  
  
• Hardouin JB (2007) Rasch analysis: estimation and tests with the Raschtest module. The Stata Journal, 7(1): 22-44.
  
  
• Golden J, Conroy RM, Golden D, O'Dwyer AM, Hardouin JB (2006) Illness-related stigma, mood and adjustment to illness in persons with Hepatitis C. Social Science and Medicine, 63(12): 3188-98.
  
  
• Sébille V, Mesbah M (2006) Sequential Analysis of Quality of Life Rasch Measurements. In Probability, Statistics and Modelling in Public Health (Springer Statistics ; Nikulin M, Commenges D, Huber C. (eds.) ): 0.
  
  
• Sébille V, Challa T, Mesbah M (2006) Sequential Analysis of Quality of Life Measurements with the Mixed Partial Credit Model. In Advances in Statistical Methods for the Health Sciences (Springer ; Balakrishnan N, Auget J-L, Mesbah M, Molenberghs G. (eds.) ): 0.
  
  
• Hardouin JB (2005) Construction d'échelles d'items unidimensionnelles en qualité de vie. Thèse de doctorat de l'Université René Descartes - Paris 5, 201.
  
  
• Hardouin JB, Mesbah M (2004) Clustering Binary Variables in Subscales using an Extended Rasch model and Akaike Information Criterion. Communication in Statistics – Theory and Methods, 33(6): 1277-1294.
  
  
• Sébille V, Auget JL (2004) Evaluating Health-Related Quality of Life: a case-study of differential item functioning analysis in small trials. Communications in Statistics-Theory and Methods, 33(6): 1403-1428.
  
  

Publications liées à l'axe principal de recherche (Méthodologie pour les Mesures Subjectives en Santé)

• Tessier P, Thuilliez J (2018) Does freedom make a difference? : An empirical investigation of differences between subjective well-being and perceived capabilities amongst cancer patients.. The European Journal of Health Economics: .
  
  
• Perrot B, Anthoine E, Hardouin JB (2018) Validscale : A Stata module to validate measurement scales. Stata Journal, 18(1): 29-50.
  
  
• Rousselet M, Feuillet F, Gérardin M, Jolliet P, Hardouin JB, Victorri-Vigneau C (2017) The French addictovigilance network clinical assessment: Z-drugs, true false twins. Expert Opinion on Drug safety, 16(9): 1063-1069.
  
  
• Rouquette A, Hardouin JB, Coste J (2016) Differential Item Functioning (DIF) ans subsequent bias in group comparisons using a composite measurement scale: a simulation study. Journal of Applied Measurement, 17(3): 312-334.
  
  
• Blanchin M, Hardouin JB, Bonnaud-Antignac A, Sébille V (2016) Analysis of longitudinal patient reported outcomes data with Classical Test Theory and Rasch-based methods: an application on health-related quality of life in breast cancer patients. Statistica Applicata – Italian Journal of Applied Statistics, 27(1): 41-56.
  
  
• Péron E, Hardouin JB, Feuillet F, Wainstein L, Chaslerie A, Pivette J, Jolliet P, Victorri-Vigneau C (2016) Selective Serotonin Reuptake Inhibitors, are they all the same? a pharmacoepidemiological approach . Advances in Pharmacoepidemiology and Drug Safety, 5(3): 1000203.
  
  
• Bruneau M, Grall-Bronnec M, Vénisse JL, Romo L, Valleur M, Magalon D, Fatseas M, Chéreau-Boudet I, Luquiens A, JEU Group , Challet G, Hardouin JB (2016) Gambling transitions among adult gamblers: A multi-state model using a Markovian approach applied to the JEU cohort. Addictive Behaviors, 57: 13-20.
  
  
• Wainstein L, Victorri-Vigneau C, Sébille V, Hardouin JB, Feuillet F, Pivette J, Chaslerie A, Jolliet P (2011) Pharmacoepidemiological characterization of psychotropic drugs consumption using a latent class analysis. International Clinical Psychopharmacology, 26(1): 54-62.