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A study of the quality of life and cost-utility of renal transplantation
Abstract
The objective of this study was to assess the cost-utility of renal transplantation compared with dialysis. To accomplish this, a prospective cohort of pre-transplant patients were followed for up to two years after renal transplantation at three University-based Canadian hospitals. A total of 168 patients were followed for an average of 19.5 months after transplantation. Health-related quality of life was assessed using a hemodialysis questionnaire, a transplant questionnaire, the Sickness Impact Profile, and the Time Trade-Off Technique. Fully allocated costs were determined by prospectively recording resource use in all patients. A societal perspective was taken. By six months after transplantation, the mean health-related quality of life scores of almost all measures had improved compared to pre-transplantation, and they stayed improved throughout the two years of follow up. The mean time trade-off score was 0.57 pre-transplant and 0.70 two years after transplantation. The proportion of individuals employed increased from 30% before transplantation to 45% two years after transplantation. Employment prior to transplantation [relative risk (RR) = 23], graft function (RR 10) and age (RR 1.6 for every decrease in age by one decade), independently predicted employment status after transplantation. The cost of pre-transplant care (66,290) were similar. Transplantation was considerably less expensive during the second year after transplantation ($27,875). Over the two years, transplantation was both more effective and less costly than dialysis. This was true for all subgroups of patients examined, including patients older than 60 and diabetics. We conclude that renal transplantation was more effective and less costly than dialysis in all subgroups of patients examined.
... The need for kidney replacement therapies is a major public health issue, with worldwide use expected to total 5,439 million patients (3,899 to 7,640 million) in 2030. 1 Kidney transplantation is considered the treatment of choice, improving both quality of life and life expectancy as compared to remaining on dialysis. 2,3 Still, there is a shortage of organs available for donation. ...
... The need for kidney replacement therapies is a major public health issue, with worldwide use expected to total 5,439 million patients (3,899 to 7,640 million) in 2030. 1 Kidney transplantation is considered the treatment of choice, improving both quality of life and life expectancy as compared to remaining on dialysis. 2,3 Still, there is a shortage of organs available for donation. Optimizing long-term post-transplantation care is crucial to limit the need for novel transplantations. ...
Objective: This study sought to compare the drop in predictive performance over time according to the modeling approach (regression versus machine learning) used to build a kidney transplant failure prediction model with a time-to-event outcome. Study Design and Setting: The Kidney Transplant Failure Score (KTFS) was used as a benchmark. We reused the data from which it was developed (DIVAT cohort, n=2,169) to build another prediction algorithm using a survival super learner combining (semi-)parametric and non-parametric methods. Performance in DIVAT was estimated for the two prediction models using internal validation. Then, the drop in predictive performance was evaluated in the same geographical population approximately ten years later (EKiTE cohort, n=2,329). Results: In DIVAT, the super learner achieved better discrimination than the KTFS, with a tAUROC of 0.83 (0.79-0.87) compared to 0.76 (0.70-0.82). While the discrimination remained stable for the KTFS, it was not the case for the super learner, with a drop to 0.80 (0.76-0.83). Regarding calibration, the survival SL overestimated graft survival at development, while the KTFS underestimated graft survival ten years later. Brier score values were similar regardless of the approach and the timing. Conclusion: The more flexible SL provided superior discrimination on the population used to fit it compared to a Cox model and similar discrimination when applied to a future dataset of the same population. Both methods are subject to calibration drift over time. However, weak calibration on the population used to develop the prediction model was correct only for the Cox model, and recalibration should be considered in the future to correct the calibration drift.
... Kidney transplantation is the best treatment option for patients with end-stage renal disease (ESRD) [1][2][3][4]. Owing to recent improvements in available immunosuppressants (ISs), kidney transplantation has become the best treatment for ESRD in older adults [5,6]. In Japan, the number of recipients between the ages of 60 and 79 years was higher in 2015 than in 2007 [7] and continues to increase. ...
Background/Objectives: The number of older adults requiring a kidney transplant (KT) is increasing; hence, postoperative sarcopenia prevention is necessary. KT recipients require permanent oral immunosuppressants (ISs), and the gut microbiota (GM) plays a role in various systemic diseases. However, few studies have evaluated post-kidney transplantation frailty and the associations among ISs, GM, and muscle mass alterations. Therefore, we investigated the effects of ISs on GM and skeletal muscle mass in mice and human KT recipients. Methods: Mice were treated with six different ISs, and their skeletal muscle mass, GM diversity, and colonic mucosal function were assessed. Human KT recipients and donors were monitored before and after surgery for 1 year, and GM diversity was evaluated before and 1 month after surgery. Results: The abundance of Akkermansia, crypt depth, and mucin 2 expression were lower in tacrolimus- and prednisolone-treated mice. The psoas muscle volume changes at 1 month and 1 year after surgery were lower in KT recipients than in donors. Furthermore, the beta diversity was significantly different between the operative groups (p = 0.001), and the KT group showed the lowest Shannon index. Conclusions: The findings of this study indicate potential links among ISs, GM, and muscle mass decline. Further investigation is required to improve therapeutic strategies and patient outcomes.
... Kidney transplantation is the best treatment option for improving survival rates, reducing complications, and enhancing the quality of life in patients diagnosed with chronic kidney disease. However, only a limited number of patients can benefit from this treatment [2][3][4]. Most patients undergo chronic hemodialysis therapy requiring effective vascular access. ...
Objective: This study aimed to examine the vascular access routes used by patients undergoing hemodialysis treatment in our province and determine the prevalence of arteriovenous (AV) fistula use. Methods: Patients who were receiving regular hemodialysis treatment in Burdur province as of April 2024 were included in the study. Data on patients' age, gender, comorbidities, duration of dialysis, type of vascular access, and history of hemodialysis access were retrospectively reviewed and recorded using electronic patient records. Results: The mean age of 197 patients evaluated in the study was 62.48±14.13 years. Of the patients, 63 (32%) were female and 134 (68%) were male. Hypertension was the most common comorbidity in 61.9% of the cases. The number of patients receiving hemodialysis treatment through an AV fistula was 136 (69%). The mean age of patients receiving treatment via an AV fistula was significantly lower than those receiving treatment via an indwelling hemodialysis catheter (P=0.011). Among the patients treated with an indwelling hemodialysis catheter, 59% had no history of AV fistula surgery. The mean age of patients without a history of AV fistula surgery was statistically significantly higher than those with a history of AV fistula surgery (69.28±14.98 vs. 60.96±13.52, respectively; P=0.001). Conclusions: This study shows that one out of every two patients undergoing hemodialysis through an indwelling hemodialysis catheter has no history of AV fistula surgery. Reaching these patients and prioritizing AV fistula planning is crucial for achieving long-term success in hemodialysis treatment and reducing complications.
... Kidney transplantation is the preferred therapy of patients with end-stage kidney failure since it reduces mortality and improves the quality of life compared to dialysis treatment (1,2). Little is known about the mechanisms of regulatory T cells (Tregs) and responder T cells (Tresps) in patients with stable transplant kidney function compared to those who experience a deterioration in kidney function. ...
Background
The role of regulatory CD8pos T cells (CD8pos Tregs) and cytotoxic CD8pos responder T cells (CD8pos Tresps) in maintaining stable graft function in kidney transplant recipients (KTR) remains largely unclear. The pathogenesis of graft deterioration in case of rejection involves the exhaustive differentiation of both CD8pos T cell subsets, but the causal mechanisms have not yet been identified.
Methods
In this study, we separately investigated the differentiation of CD8posTregs/Tresps in 134 stable KTR with no evidence of renal graft rejection, in 41 KTR diagnosed with biopsy-confirmed rejection at enrolment and in 5 patients who were unremarkable at enrolment, but developed rejection within three years of enrolment. We were investigating whether changed differentiation of CCR7posCD45RAposCD31pos recent thymic emigrant (RTE) cells via CD45RAnegCD31pos memory (CD31pos memory) cells (pathway 1), via direct proliferation (pathway 2), or via CCR7posCD45RA⁺CD31neg resting mature naïve (MN) cells (pathway 3) into CD45RAnegCD31neg memory (CD31neg memory) cells affects the CD8pos Treg/Tresp ratio or identifies a CD8pos Treg/Tresp subset that predicts or confirms renal allograft rejection.
Results
We found that RTE Treg differentiation via pathway 1 was age-independently increased in KTR, who developed graft rejection during the follow-up period, leading to abundant MN Treg and central memory Treg (CM Treg) production and favoring a strongly increased CD8pos Treg/Tresp ratio. In KTR with biopsy-confirmed rejection at the time of enrolment, an increased differentiation of RTE Tregs into CCR7negCD45RAposCD31neg terminally differentiated effector memory (CD31neg TEMRA Tregs) and CD31pos memory Tregs was observed. CD31neg memory Treg production was maintained by alternative differentiation of resting MN Tregs, resulting in increased effector memory Treg (EM Treg) production, while the CD8pos Treg/Treg ratio was unaffected. An altered differentiation of CD8pos Tresps was not observed, shifting the Treg/Tresp ratio in favor of Tregs.
Conclusions
Our results show that exhaustive CD8pos Treg differentiation into CM Tregs may lead to future rejection, with a shift towards EM Treg production and an accumulation of CD31neg TEMRA Tregs in KTR with current rejection.
... Sappiamo ormai come il trapianto di rene rappresenti l'opzione terapeutica più efficace in termini di qualità della vita, sopravvivenza e rapporto costo-beneficio nei pazienti affetti da malattia renale cronica (1,2). Tuttavia, come tutte le terapie, non è privo di effetti collaterali e complicanze. ...
De novo malignancies after kidney transplantation Cancer is the second cause of death in kidney transplant patients in most Western countries. The excess risk of cancer after kidney transplantation is two to three times higher than in the age and sex matched general population. Once cancer develops, the outcome is generally poor, particularly for melanoma, renal cell carcinoma and post-transplant lymphoproliferative disorder. A multidisciplinary approach for screening, prevention, diagnosis and treatment of neoplastic disease after kidney transplantation is necessary. e sarcoma di Kaposi (6,7). Al contrario non si riscontra un aumento di rischio rispetto alla popolazione generale per quanto riguarda le neoplasie mammaria e prostatica (Fig. 1). Mortalità Una volta sviluppatasi, i tassi di mortalità standard per tutti i tipi di neoplasia sono almeno 1,8-1,9 volte più alti che nella popolazione generale con un ulteriore aumento del rischio fino a 5-10 volte per i soggetti affetti da melanoma, tumore urogenitale e linfoma non-Hodgkin (8). Introduzione Sappiamo ormai come il trapianto di rene rappresenti l'opzione terapeutica più efficace in termini di qualità della vita, sopravvivenza e rapporto costo-beneficio nei pazienti affetti da malattia renale cronica (1,2). Tuttavia, come tutte le terapie, non è privo di effetti collaterali e complicanze. Una delle più temute, legata allo stato di immunosoppressione cronica, è quella neoplastica (3) che rappresenta la seconda causa di morte dopo la malattia cardiovascolare nei pazienti che ricevono un trapianto renale (4). Si evince, dunque, quanto sia essenziale, dove possibile, applicare tutte le misure a disposizione in ambito di preven-zione, diagnosi precoce e trattamento.
Objective - To determine whether recombinant human erythropoietin improves the quality of life and exercise capacity of anaemic patients receiving haemodialysis. Design - A double blind, randomised, placebo controlled study. Setting - Eight Canadian university haemodialysis centres. Patients - 118 Patients receiving haemodialysis aged 18-75 with haemoglobin concentrations <90 g/l, no causes of anaemia other than erythropoietin deficiency, and no other serious diseases. Interventions - Patients were randomised to three groups to receive placebo (n=40), erythropoietin to achieve a haemoglobin concentration of 95-110 g/l (n=40), or erythropoietin to achieve a haemoglobin concentration of 115-130 g/l (n=38). Erythropoietin was given intravenously thrice weekly, initially at 100 units/kg/dose. The dose was subsequently adjusted to achieve the target haemoglobin concentration. All patients with a serum ferritin concentration less than 250 μg/l received oral or intravenous iron for one month before the study and as necessary throughout the trial. Main outcome measures - Scores obtained with kidney disease questionnaire, sickness impact profile, and time trade off technique; and results of six minute walk test and modified Naughton stress test. Results - The mean (SD) haemoglobin concentration at six months was 74 (12) g/l in patients given placebo, 102 (10) g/l in those in the low erythropoietin group, and 117 (17) g/l in those in the high erythropoietin group. Compared with the placebo group, patients treated with erythropoietin had a significant improvement in their scores for fatigue, physical symptoms, relationships, and depression on the kidney disease questionnaire and in the global and physical scores on the sickness impact profile. The distance walked in the stress test increased in the group treated with erythropoietin, but there was no improvement in the six minute walk test, psychosocial scores on the sickness impact profile, or time trade off scores. There was no significant difference in the improvement in quality of life or exercise capacity between the two groups taking erythropoietin. Patients taking erythropoietin had a significantly increased diastolic blood pressure despite an increase in either the dose or number of antihypertensive drugs used. Eleven of 78 patients treated with erythropoietin had their sites of access clotted compared with only one of 40 patients given placebo. Conclusions - Patients receiving erythropoietin were appreciably less fatigued, complained of less severe physical symptoms, and had moderate improvements in exercise tolerance and depression compared with patients not receiving erythropoietin. At the doses used in this trial there was a higher incidence of hypertension and clotting of the vascular access in patients treated with erythropoietin.
Objective.
—To compare mortality risk among cadaveric renal transplant recipients vs transplant candidates on dialysis in the cyclosporine era.Setting.
—Patient mortality risk was analyzed by treatment modality for a completed statewide patient population.Patients.
—All Michigan residents younger than age 65 years who started end-stage renal disease (ESRD) therapy between January 1,1984, and December 31, 1989, were included. Patients were followed up from ESRD onset (n=5020), to wait-listing for renal transplant (n=1569), to receiving a cadaveric first transplant (n=799), and to December 31, 1989.Main Outcome Measure.
—Mortality rates.Results.
—Using a time-dependent variable based on the waiting time from date of wait-listing to transplantation and adjusting for age, sex, race, and primary cause of ESRD, the relative risk (RR) of dying was increased early after transplantation and then decreased to a beneficial long-term effect, given survival to 365 days after transplantation (RR, 0.36; P<.001). This lower long-term risk was most pronounced (RR, 0.25) among diabetic transplant recipients compared with diabetic wait-listed dialysis patients (P<.001) and not observed among patients with glomerulonephritis as cause of ESRD (P>.05). Overall, the estimated times from transplantation to equal mortality risk was 117±28 days and to equal cumulative mortality was 325±91 days.Conclusions.
—The overall mortality risk following renal transplantation was initially increased, but there was a long-term survival benefit compared with similar patients on dialysis. These analyses allow improved description of comparative mortality risks for dialysis and transplant patients and allow advising patients regarding comparative survival outcomes.(JAMA. 1993;270:1339-1343)
Because economic evaluations of health care services are being published with increasing frequency it is important to (a) evaluate them rigorously and (b) compare the net benefit of the application of one technology with that of others. Four "levels of evidence" that rate economic evaluations on the basis of their methodologic rigour are proposed. They are based on the quality of the methods used to estimate clinical effectiveness, quality of life and costs. With the use of the magnitude of the incremental net benefit of a technology, therapies can also be classified into five "grades of recommendation." A grade A technology is both more effective and cheaper than the existing one, whereas a grade E technology is less or equally effective and more costly. Those of grades B through D are more effective and more costly. A grade B technology costs less than 20,000 to 100,000/QALY. Many issues other than cost effectiveness, such as ethical and political considerations, affect the implementation of a new technology. However, it is hoped that these guidelines will provide a framework with which to interpret economic evaluations and to identify additional information that will be useful in making sound decisions on the adoption and utilization of health care services.
Methodologically sound measures of quality of life are required to judge accurately the impact of successful renal transplantation on patient well-being. The time trade-off (TTO) method is a reproducible and valid measure which we used to prospectively assess changes in the quality of life of 27 patients on maintenance dialysis who subsequently underwent renal transplantation. TTO scores approaching 0 signify a very poor quality of life, while scores approaching 1 represent perfect health. Of 98 dialysis patients who completed baseline TTO interviews, 31 consecutive patients subsequently received 28 cadaveric and 3 living related kidney transplants. Four of 31 patients did not complete a second TTO assessment, because of death in 2 patients and graft loss in 2 others. The remaining 27 patients completed a second TTO interview an average of 30.9 months following transplantation (range 1.5-52, 95% confidence interval [CI] 24.4-37.5) and formed the study cohort. At the time of study the mean serum creatinine for the cohort was 173 mumol/L (range 90-290, 95% CI 152-195 mumol/L). The employment rate rose 27% following transplantation (P = 0.10); but when males alone were analyzed, a significant increase of 38% (P = 0.048) was noted. During the dialysis period, the mean baseline TTO score was 0.41 (95% CI 0.33-0.49), confirming the observations of others. Following transplantation, the mean TTO score rose to 0.74 (95% CI 0.67-0.81), a difference that is statistically significant (P < 0.001). The mean increase in TTO score observed as a result of successful transplantation was 0.33 (95% CI 0.26-0.40). This magnitude of improvement was found in 20 of 27 patients (74%), whose TTO scores lay within or above the 95% CI (0.26-0.40) for the mean change in score of 0.33. One patient's score fell, while the remaining 6 patients had improvements in their TTO score which fell below the lower 95% CI value (0.26) for the mean change in score. We conclude that the 95% CI of 0.26-0.40 identifies a range in which clinically important improvements in quality of life will be found for the majority of patients receiving successful kidney transplants.
The quality of life of 12 hemodialysis (HD) patients was assessed in a prospective, blinded, cross-over fashion before treatment with recombinant human erythropoietin (r-HuEPO) and at two different levels of hemoglobin (Hb, 9 and 12 g/dl) by means of an interviewer-based questionnaire, the sickness impact profile (SIP). Patients were matched into two groups with no significant difference for age, weight, Hb (6.3 +/- 0.5, mean +/- SEM, group A, vs. 6.4 +/- 0.9 group B), length of hemodialysis or number of years of prior transplantation. SIP was assessed prior to treatment, after reaching the first target Hb (Hb 9 g/dl group A, 12 g/dl group B), after 4 months at that target Hb and after 4 months at the alternative target Hb for each group. For all patients, there was a highly significant improvement in quality of life as assessed by lower SIP scores between the initial and second assessments. This was evident for the physical (8.9 +/- 1.4 vs. 2.8 +/- 1.0; p less than 0.001) and psychosocial (14.9 +/- 3.9 vs. 4.4 +/- 1.1; p less than 0.01) dimensions. Total scores (16.3 +/- 2.4 vs. 5.7 +/- 0.9; p less than 0.001) showed similar changes, reflecting significant improvement in 10 of 12 possible categories between the first two assessments (p less than 0.05 to p less than 0.001). Improved scores were maintained but did not change appreciably after the 2nd assessment. There was no significant difference in any score (category, dimensional or total) obtained after 4 months at Hb 9 g/dl compared to those after the same period at Hb 12 g/dl.(ABSTRACT TRUNCATED AT 250 WORDS)
A disease-specific questionnaire was developed for patients receiving chronic hemodialysis by interviewing patients to determine which aspects of their quality of life were adversely affected by their disease. The final questionnaire contained 26 questions in five dimensions (physical symptoms, fatigue, depression, relationships with others, frustration). The questionnaire demonstrated construct validity when compared with the Sickness Impact Profile, time trade-off technique and an exercise stress test. It was reproducible in stable, placebo-treated patients (correlation coefficient 0.85-0.98 for the 5 dimensions). It was more responsive than other measures in detecting an improvement with erythropoietin therapy in a randomized, placebo-controlled trial. This questionnaire should be useful for the assessment of the effect of various interventions upon the quality of life of hemodialysis patients.
Controlled clinical trials are recognized as the best source of data on the efficacy of health care interventions and technologies. Because economic evaluation is dependent on the quality of the underlying medical evidence, clinical trials have increasingly been viewed as a natural vehicle for economic analysis. However, the closer integration of economic and clinical research raises many methodological issues. This paper discusses these issues in trial design, collection of resource use data, collection of outcome data, and interpretation and extrapolation of results. Some guidelines are suggested for economic analysts wishing to undertake evaluations alongside clinical trials.
This study investigates the quality of life of patients on alternative therapies for end-stage renal disease. The quality of life of 766 patients who experienced one of the following therapies for at least one year are compared: a successful transplant performed in the 1970's (N = 82), a successful transplant performed in 1980-1984 (N = 91), in-center hemodialysis (N = 83, 8 centers), and continuous ambulatory peritoneal dialyses (CAPD) (N = 510, 185 centers). All patients were aged 19-56 and nondiabetic. Survey questionnaires were administered containing measures of physical, emotional and social well-being, vocational rehabilitation, and sexual adjustment. Case-mix differences were controlled, insofar as possible, with an Analysis of Covariance; adjusted means were compared. Findings indicate that the quality of life for successful transplant patients exceeds that of both dialysis groups for almost all variables (p less than 0.05 for 9/11 measures). This advantage persists when transplant patients are compared to dialysis patients who have experienced no prior, failed therapies.