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Rationale & Objective: Health-related quality of life (HRQoL) is a major outcome measure increasingly used in patients with chronic kidney disease (CKD). We evaluated the association between different stages of CKD and the physical and mental health domains of HRQoL., Study Design: Cross-sectional study., Setting & Participants: 2,693 outpatients with moderate (stage 3, estimated glomerular filtration rate [eGFR], 30-60mL/min/1.73m 2 ) or advanced (stages 4-5, estimated glomerular filtration rate<30mL/min/1.73m 2 , not on kidney replacement therapy [KRT]) CKD under the care of a nephrologist at 1 of 40 nationally representative facilities, 1,658 patients with a functioning kidney transplant, 1,251 patients on maintenance dialysis randomly selected from the national Renal Epidemiology and Information Network registry, and 20,574 participants in the French Decennial Health Survey, representative of the general population., Predictor: Severity of kidney disease (moderate CKD, advanced CKD, maintenance dialysis as KRT, and functioning kidney transplant as KRT), compared with a sample of the general population., Outcomes: HRQoL scores assessed using the Medical Outcomes Study 36-Item Short Form Health Survey or the Kidney Disease Quality of Life 36 scale., Analytical Approach: Age- and sex-standardized (to the general population) prevalence of poor or fair health status was estimated for each study kidney disease group. Analysis of variance was used to estimate adjusted differences in mean physical and mental health scores between the kidney disease subgroups and the general population., Results: Mean age was 67.2±12.6 (SD) years for patients with non-KRT-requiring CKD, 69.3±17.7 years for dialysis patients, and 55.3±14.2 years for those with functioning kidney transplants; 60% were men. Age- and sex-standardized health status was perceived as fair or poor in 27% of those with moderate CKD,>40% of those with advanced CKD or receiving dialysis, 12% with a functioning transplant, and 3% of the general population sample. HRQoL physical scores (adjusted for age, sex, education, obesity, and diabetes) were significantly lower in patients in all CKD subgroups than in the general population. For patients receiving dialysis, the magnitude of the difference in physical score versus the general population exceeded 4.5 points, the minimal clinically important difference for this score in this study; for both kidney transplant recipients and patients with advanced CKD, the magnitude of the difference was close to this threshold. For mental score, only dialysis patients had a score that differed from that of the general population by more than the minimal clinically important difference., Limitations: Cross-sectional study design for each subpopulation., Conclusions: This study highlights the degree to which perceived physical health is lower in the setting of CKD than in the general population, even in the absence of kidney failure, and calls for greater attention to CKD-related quality of life., (Copyright © 2019 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Background: This study describes the time trend of renal replacement therapy for end-stage renal disease (ESRD) in the Provence-Alpes Côte d'Azur region (PACA) between 2004 and 2015, and forecasts up to 2030., Methods: A longitudinal study was conducted on all ESRD patients treated in PACA and recorded in the French Renal Epidemiology and Information Network (REIN) during this period. Time trends and forecasts to 2030 were analyzed using Poisson regression models., Results: Since 2004, the number of new patients has steadily increased by 3.4% per year (95% CI, 2.8-3.9, p < 0.001) and the number of patients receiving RRT has increased by 3.7% per year (RR 1.037, 95% CI: 1.034-1.039, p < 0.001). If these trends continue, the PACA region will be face with 7371 patients on dialysis and 3891 with a functional renal transplant who will need to be managed in 2030. The two most significant growth rates were the percentage of obese people (RR 1.140, 95% CI: 1.131-1.149, p < 0.001) and those with diabetes (RR 1.070, 95% CI; 1.064-1.075, p < 0.001)., Conclusion: This study highlights the increase in the number of ESRD patients over 12 years, with no prospect of stabilization. These findings allow us to anticipate the quality and quantity of care offered and to propose more preventive measures to combat obesity and diabetes.

Background: Health-Related Quality of Life (HRQoL) assessment after kidney transplantation has become an important tool in evaluating outcomes. This study aims to identify the associated factors with HRQoL among a representative sample size of Kidney Transplant Recipients (KTR) at the time of their inclusion in the study., Methods: Data of this cross-sectional design is retrieved from a longitudinal study conducted in five French kidney transplant centers in 2011, and included KTR aged 18 years with a functioning graft for at least 1 year. Measures include demographic, psycho-social and clinical characteristics. To evaluate HRQoL, the Short Form-36 Health Survey (SF-36) and a HRQoL instrument for KTR (ReTransQol) were administered. Multivariate linear regression models were performed., Results: A total of 1424 patients were included, with 61.4% males, and a mean age of 55.7 years (±13.1). Demographic and clinical characteristics were associated with low HRQoL scores for both questionnaires. New variables were found in our study: perceived poor social support and being treated by antidepressants were associated with low scores of Quality of Life (QoL), while internet access was associated with high QoL scores., Conclusion: The originality of our study's findings was that psycho-social variables, particularly KTR treated by antidepressants and having felt unmet needs for any social support, have a negative effect on their QoL. It may be useful to organize a psychological support specifically adapted for patients after kidney transplantation.

Background: The use of the Internet for searching and sharing health information and for health care interactions may have a great potential for Renal Transplant Recipients (RTR). This study aims to determine the characteristics associated with Internet and social network use in a representative sample of RTR at the time of their inclusion in the study., Methods: Data of this cross-sectional design is retrieved from a longitudinal study conducted in five French kidney transplant centers in 2011, and included Renal Transplant Recipients aged 18 years with a functioning graft for at least 1 year. Measures include demographic characteristics (age, gender, level of education, employment status, living arrangement, having children, invalidity and monthly incomes in the household), psycho-social characteristics measured by the perceived social support questionnaire, and medical characteristics (previous dialysis treatment, duration since transplantation, graft rejection episodes, chronic graft dysfunction, health status and comorbidities: neoplasia for the current transplant, hypertension, diabetes mellitus, smoking status, BMI > 30 kg/m 2 and Charlson Comorbidity Index (CCI)). Polytomous linear regression analysis was performed to describe the Internet and social network users' profiles, using lack of Internet access as the comparison category., Results: Among the 1416 RTR participating in the study, 20.1% had no Internet access in the household, 29.4% connected to social networks and 50.5% were not connected to social networks. Patients who connected the most to the Internet and social networks were younger, male, without children, employed, with high monthly incomes in the household, without hypertension and having felt a need for an informative or an esteem support., Conclusion: In our study, the majority of RTR were actively using Internet and social networks. Renal transplant units should develop flexible and Web-based sources related to transplant information, which will allow a rapid adaptation to changes in prevalent practice, improve the health of the patients and reflect their preferences.

Background: Renal transplantation is considered as the treatment of choice for patients with end-stage renal disease. Health-related quality of life (HRQoL) of renal transplant recipients (RTR) is very important to assess, especially during the first year after transplantation. To provide new evidence about the suitability of HRQoL measures in RTR during the first post-transplant year, we explored the internal structure, reliability and external validity of a French specific HRQoL instrument, the Renal Transplant Quality of life Questionnaire Second Version (RTQ V2)., Methods: The data were issued from the French multicenter cohort of renal transplant patients followed during 4 years (EPIGREN). The HRQoL of RTR was assessed five times (at 1, 3, 6, 9 and 12 months after transplantation) with the RTQ V2, a specific instrument consisting of 32 items describing five dimensions. Socio-demographic information, clinical characteristics and HRQoL (i.e., RTQ V2 and SF-36) were collected. For the five times, psychometric properties of the RTQ V2 were compared to those reported from the reference population assessed in the validation study., Results: Three hundred and thirty-four patients were enrolled. The proportions of well-projected items, item-internal consistency, item-discriminant validity, floor and ceiling effects, Cronbach's alpha coefficients and item goodness-of-fit statistics were satisfactory for each dimension at the five times of the study. The suitability indices of construct validity were higher than 90 % for each time (minimum-maximum: 90.8-97.4 %). The external validity was less satisfactory, with a suitability indices ranged from 46.7 % at M1 to 66.7 % at M12. However, the discrepancies with the reference population (mainly for the gender) appeared logical considering the scientific literature on HRQoL of RTR during the first post-transplant year and may not compromise the external validity., Conclusion: These results support the validity and reliability of the RTQ V2 for evaluating HRQoL in RTR during the first post-transplant year, and confirm that the RTQ V2 is a useful tool to assess the HRQoL precociously after transplant.

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.

Background: End stage renal disease (ESRD) profoundly impacts the lives of patients. Kidney transplantation provides the greatest health-related quality of life (HRQOL) improvement. Its measurement has become an important outcome parameter and a very important criterion in the evaluation of any type of medical treatment, especially in the field of renal transplantation.In 2007, a specific self-administered questionnaire for renal transplant recipients was developed in the French language: the ReTransQol (RTQ).After 5 years of use, the properties of the RTQ needed to be re-evaluated in a larger sample.This paper describes the analysis of the ReTransQol and its adaptation to achieve an improved and revised version., Methods: The study design included three analysis phases for two samples of adult renal transplant recipients which came from two cross-sectional multicenter studies carried out in France in 2007 and 2012. Psychometrics properties like construct validity, acceptability and feasibility, reliability and convergent validity were evaluated and every analysis resulted in a new version of the questionnaire: the RTQ V2. The construct validity of the new RTQ was assessed with a Confirmatory Factor Analysis on a large sample of patients., Results: The study samples included 1,059 patients and 1,591 patients, respectively. After a principal component analysis, item reduction was performed and a total of 13 items were deleted. A final version of the RTQ V2 was created and comprised of 32 items describing 5 domains: Physical Health, Social Functioning, Medical Care, Treatment and Fear of Losing Graft.The explained variance between the first and second RTQ versions improved from 46.3% to 53.1%. All psychometric properties of RTQ V2 were satisfactory: IIC >0.4, IDV (%) of 100% and Cronbach's Alpha >0.7 in every dimension. The confirmatory analysis showed that the overall scalability of the RTQ V2 was satisfactory; all items showed a good fit to the Rasch model within each dimension, and showed INFIT statistics inside the acceptable range., Conclusions: Psychometric properties allow this new version of the questionnaire to be used to assess different specific dimensions for the renal transplant population, more effectively than previously possible.

Background: This study aims to identify factors associated with health related quality of life (HRQOL) through a comprehensive analysis of sociodemographic and clinical variables among a representative sample size of renal transplant recipients (RTR) in France., Methods: A cross-sectional multicenter study was carried out in 2008. All RTR over 18 years old with a functioning graft for at least one year were included. Data included socio-demographic, health status, and treatment characteristics. To evaluate HRQOL, the Short Form-36 Health Survey (SF-36) and a HRQOL instrument for RTR (ReTransQol) were administered. Multivariate linear regression models were performed., Results: A total of 1061 RTR were included, with a return rate of 72.5%. The variance explained in regression models of SF-36 ranges from 20% to 40% and from 9% to 33% for ReTransQol., Conclusions: The originality of our study's findings was that novel variables, particularly treatment side effects and unemployment, have a negative effect on quality of life of RTR. The French Biomedicine Agency and the National Health Institute for Public Health Surveillance conduct specific actions for professional reintegration and therapeutic education programs in the national plan to improve the HRQOL of people living with chronic diseases.

Background: In the absence of a French health-related quality of life (QOL) instrument for renal transplant recipients (RTR), we developed a self-administered questionnaire: the ReTransQol (RTQ)., Methods: This questionnaire was developed using classical methodology in the following three phases over a two-year period: Item Generation phase, identifying all possible items having adverse impact on the QOL of RTR, Item Reduction phase, selecting the most pertinent items related to QOL, and Validation phase, analyzing the psychometric properties. All RTR involved in these phases were over 18 and were randomly selected from a transplant registry., Results: Item generation was conducted through 24 interviews of RTR. The first version of RTQ (85 items) was sent to 225 randomized RTR, and 40 items were eliminated at the end of the item reduction phase. The second version of RTQ (45 items) was validated from 130 RTR, resulting in the RTQ final version. The factor analysis identified a structure of five factors: Physical Health (PH), Mental Health (MH), Medical Care (MC), Fear of losing the Graft (FG) and Treatment (TR). The psychometric properties of RTQ were satisfactory. Comparison between known groups from the literature confirmed the construct validity: patients without employment or living alone have lower QOL scores, and women have lower QOL scores than men. RTQ was more responsive than SF36 to detect changes in the QOL of RTR who were hospitalized secondary to their renal disease in the 4 weeks preceding their inclusion., Conclusion: According to French public health priorities, RTQ appears to be a reliable and valid questionnaire.