Background
End stage renal disease, dialysis and transplantation
Psychological impact of dialysis and transplantation
Longitudinal data and response shift
Aims and objectives
Methods/Design
Study design
Study setting and participants
Inclusion criteria
Primary outcome measure
Secondary outcome measures
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The change in generic QoL, subjective well-being, perceived anxiety and depressive disorders as well as perceived stress during follow-up (every 6 months before the surgery, at hospital discharge, 3, 6, 12, and 24 months post-transplantation) taking into account the possible occurrence of response shift. Generic QoL will be assessed with the SF-36 questionnaire. This questionnaire has the disadvantage of not being specific, and therefore less sensitive to specific changes in the health status of the recipient. However, it allows a comparison of the results to a reference population [25] and allows an easier comparison of the patients in different therapeutic frameworks (for example patients before and after transplantation). Subjective well-being, anxiety and depressive disorders, and perceived stress will be assessed using the satisfaction with life scale (SWLS) [26, 27], the Hospital Anxiety and Depression scale (HAD) [28, 29], and the Perceived Stress Scale (PSS) [30], respectively.
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Coping strategies (process of managing stressful circumstances) and post-traumatic growth (positive psychological change experienced as a result of the struggle with highly challenging life circumstances) at 6 and 24 months post-transplantation. Coping strategies and post-traumatic growth will be assessed using with the Brief Cope [31] and the Posttraumatic Growth Inventory (PTGI) [32], respectively.
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The post-transplantation graft and patient outcomes collected at hospital discharge, and 3, 6, 12 and 24-months post-transplantation: i) evolution of the Graft Filtration Rate (GFR) that will be estimated using the 4-variables MDRD formula [33], ii) evolution of the daily proteinuria that will be diagnosed by a simple dipstick test.
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The Kidney Transplant Failure Score at one year post-transplantation [34]. The KTFS is able to predict death-censored graft survival.
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The post-transplantation time to return to work, if appropriate.
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The compliance of patients will be assessed every six months prior to surgery, at hospital discharge, and at 3, 6, 12, and 24 months with the Girerd questionnaire [35].
Recipient | Age, gender, weight, height, clinical center, initial disease (glomerulonephritis, diabetes, etc.), cold ischemia time, HLA A-B-DR incompatibilities, number of post transplantation dialyses, pre-transplantation anti HLA immunization whatever the technique used within the six months prior to surgery, cardiovascular history, cancer history, hypertension history, diabetes history, pre transplantation dialysis technique, previous educational program. |
Donor | Age, gender, last serum creatinine level, cause of death, hypertension history. |
Dates | Birth, first dialysis, registration on waiting list, transplantation, acute rejection episodes, return to work, return in dialysis, last follow-up, death. |
The biological follow-up at hospital discharge, three, six, 12 and 24 months | The creatininemia (1) and the daily proteinuria. |
Activities | Every six months before transplantation | Hospital discharge | M3 | M6 | M12 | M24 |
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Demographic data | X | |||||
Previous medical history | X | |||||
Transplantation data | X | |||||
Donor data | X | |||||
Creatininemia and proteinuria | X | X | X | X | X | |
ReTransQol questionnaire | X | X | X | X | X | X |
SF36 questionnaire | X | X | X | X | X | X |
Satisfaction with Life Scale (SWLS) questionnaire | X | X | X | X | X | X |
The Perceived Stress Scale (PSS) | X | X | X | X | X | X |
The Brief Cope | X | X | ||||
The Hospital Anxiety and Depressions Scale (HAD) | X | X | X | X | X | X |
The Post-Traumatic Growth Inventory (PTGI) | X | X | ||||
Compliance questionnaire | X | X | X | X | X | X |
Kidney Transplant Failure Score (KTFS) | X |