Ø The study estimated the potential loss of life and the lifetime cumulative risk of end-stage renal disease (ESRD) from live kidney donation. Participants 40-year-old live kidney donors of both sexes and black/white race, underwent live donor nephrectomy.
Ø Main outcome and measures Potential remaining life years lost, quality-adjusted life years (QALYs) lost and added lifetime cumulative risk of ESRD from donation.
Ø Overall 0.532–0.884 remaining life years were lost from donating a kidney. This was equivalent to 1.20%–2.34% of remaining life years (The risk was higher in male and black individuals. The study showed that 1%–5% of average-age current live kidney donors might develop ESRD as a result of nephrectomy. Most of the loss of life was predicted to be associated with chronic kidney disease (CKD) not ESRD. Most events occurred 25 or more years after donation.
Ø Live kidney donation may reduce life expectancy by 0.5–1 year in most donors. The development of ESRD in donors may not be the only measure of risk as most of the predicted loss of life predates ESRD. The study identifies the potential importance of following donors and treating risk factors aggressively to prevent ESRD and to improve donor survival
What is the level of evidence provided by this article?
Level 2
Wee Leng Gan
2 years ago
This is a case cohorts study with level 2 evidence to study the life time risks of kidney donation. Overall 0.532–0.884 remaining life years were lost from donating a kidney. This was equivalent to 1.20%–2.34% of remaining life years (or 0.76%–1.51% remaining QALYs). The risk was higher in male and black individuals. The study showed that 1%–5% of average-age current live kidney donors might develop ESRD as a result of nephrectomy. The added risk of ESRD resulted in a loss of only 0.126–0.344 remaining life years. Most of the loss of life was predicted to be associated with chronic kidney disease (CKD) not ESRD. Most events occurred 25 or more years after donation. Reducing the increased risk of death associated with CKD had a modest overall effect on the per cent loss of remaining life years (0.72%–1.9%) and QALYs (0.58%–1.33%). Smoking and obesity reduced life expectancy and increased overall lifetime risks of ESRD in non-donors. However the percentage loss of remaining life years from donation was not very different in those with or without these risk factors.
The limitation of this study include rely on the observed rates of ESRD over 15 years in actual donors and a theoretical matched cohort to calculate lifetime outcomes. Using historic mortality and disease incidence rates to make accurate future lifetime projections is a significant limitation. Limited to US population and did not include multiple stages of CKD, thus , lack of generalization.
Batool Butt
2 years ago
This study deals with the mortality risk and development of ESRD over 15 years follow up. Markov model used in the study. The study also identifies the potential importance of following up of donors and treating risk factors aggressively to prevent ESRD and to improve donor survival. Inclusion criteria included 40 year population irrespective of gender and race .The primary outcome was Loss of potential remaining life years, quality-adjusted life years (QALYs), and an increase in the lifetime cumulative risk of end-stage renal disease (ESRD)after donation. Results: The risk factors which are associated with ESRD and mortality are smoking, obesity,and diabetes mellitus. The incidence of end-stage renal disease (ESRD) after nephrectomy ranges from 1% to 5% among current living kidney donors of average age. There was 1.2-2.34 % loss of remaining life years (0.76-1.51 % QALYs).Male and black people have increased risk. Non-biological relationship to the recipient was associated with much lower loss of life years and risk of ESRD compared with those who were biologically related. Loss of life was greater in older compared with younger donors. ESKD is associated with very high mortality rate , a significant percent of loss of life was associated with CKD not ESKD. There was not a significant difference in the proportion of remaining life years lost due to donation between individuals who had these risk factors and those who did not.The limitation of the study is that donors were of variable ages and medical conditions
In short, donors should be closely monitored for their remaining life and all risk factors like smoking, obesity ,hypertension and diabetes mellitus should be well controlled to halt the progression of CKD. What is the level of evidence provided by this article?
Retrospective cohort study-level of evidence III
Nazik Mahmoud
2 years ago
The study aimed to estimate the risk of losing life or to get ESRD among kidney donors, the mean age was 40 from both sex
the result was no difference in the risk of getting kidney disease in compression with general population and the risk of losing their life by the rate of one year per life
so they concluded that kidney donation not a risk factor in decrease life expectancy but show the importance of following the donor to prevent the complications .
Level 2 evidence
Theepa Mariamutu
2 years ago
Lifetime risks of kidney donation: a medical decision analysis
Risking the life of living kidney donors for the benefits of improved life expectancy and quality of life of recipients post kidney. This study was conducted to estimate the potential loss of life years and quality adjusted life years (QALY) and life time risk of ESRD in kidney donor.
Methodology
A USA based theoretical model that uses published population data was unused to examine the risk of ESRD in donors and non-donors.
This theoretical modal had made few assumptions while conducting study:
ESRD rates – increased in donors compared with non-donor
ESRD in both donors and non-donors – associated with high mortality rates
Donor and non-donors transition through a CKD state for at least 1 year before developing ESRD.
Nephrectomy in donors will quantitatively reduce overall patient kidney function
Donors will have a greater risk of falling below a GFR threshold of 60 mL/min/1.73 m2 compared with non-donors
Cohorts are assumed to be free of hypertension, diabetes mellitus and proteinuria at donation.
CKD states will be associated with higher mortality rates as the general population, but the magnitude of this effect was examined in additional sensitivity analyses.
However, the study population was extracted from previous published studies which met the inclusion criteria.
The target population was cohort of 40-year-old patients of both sexes of black and white race from USA for whom recent published estimates of 15 year cumulative risks of ESRD in donors and non-donors were available.
Main outcomes
Outcome of interest was remaining years of life .
Life years were scaled by measures of quality and discounted at a 3% rate of time preference to calculate QALYs.
Lifetime cumulative incidence of ESRD was also calculated.
Results and Analysis
Non-donors are assumed to have 15-year cumulative ESRD risks of
0.067%- white male
0.045%- white female
0.21% – black male
0.12% – black female
Donors are assumed to have 15-year cumulative ESRD risks of
0.34%- white male
0.15%- white female
0.96% – black male
0.59% – black female
Live kidney donation was associated with an added risk of ESRD especially among those of male sex and black race.
> 50% of all ESRD events in donors occurred 25 years or more after donation
younger patients lost more potential years of life and had potentially greater risks of ESRD given longer exposure to reduced kidney function
Donors with diabetes mellitus suffered the greatest loss of life years and increased risk of ESRD.
Donation potentially shortens life in average-age donors by about 1%–2%.
Loss of life from CKD was higher compared with life lost from the ESRD health state, there were differences based on race and sex.
Having a non-biological relationship to the recipient was associated with lower risks; but most donors are related.
The loss of life from live kidney donation is projected to be far less than smoking or mild obesity
Conclusion
Telling donors whether they may be willing to give up between 0.5 and 1year of life may be a better way to convey risk than giving them an estimate of their lifetime risk of ESRD.
After donating and treating risk factors aggressively to prevent ESRD and to improve donor survival is very important.
obesity and smoking are risk factors that might develop after donation, encouraging a healthy lifestyle at donor evaluation and post donation is also important.
What is the level of evidence provided by this article?
Level 2
Last edited 2 years ago by Theepa Mariamutu
Mu'taz Saleh
2 years ago
One of the most common question we asked by the donor is the effect of donation in Life time and the risk for developing ESRD The aim of this study is to estimate the potential loss of life as well as the added lifetime risk of ESRD in average-risk kidney donors Target population 40-year-old patients of both sexes and white/black race from the USA. This is the mean age of live donors (median age 38) and for whom there are recent published estimates of 15-year cumulative risks of ESRD in non-donors and donors Results and discussion this study show that donation potentially shortens life in average-age donors by about 1%–2%. This analysis shows that short-term studies (<20 years) even with appropriate normal controls are not likely to detect an adverse effect on survival. The study also explored risk factors that can be associated with higher rates of death and ESRD such as smoking, obesity and biological relationship to the recipient. The mechanism by which low glomerular filtration rate CKD is associated with an increase in cardiovascular and all-cause mortality rate is not completely known. Based on current literature it is unclear whether there is a significant risk of death from donation, but studies have had relatively small numbers, only 0.2% lower than a non-donor This model incorporated the probability that some donors will develop diabetes mellitus, hypertension and proteinuria at a later date, and these would impact on health (overall survival and progression to ESRD) as they do in the general population. The model could have been simplified if these risk factors for CKD and ESRD were not included in the model, but this would not reflect reality. The baseline analysis also showed that white males suffer greater added long-term ESRD risks from donation than would be anticipated. For white male the added risk of an ESRD event was 1 for every 28 donors. For black male the risk was 1 in 22. One would have expected the added risk of ESRD in white male to be less than half the added risk in black male from what is known in the general population The analysis suggests that counselling and interventions to reduce weight and smoking cessation are more important to both donor and non-donor and less of an argument to deny donation. Having a non-biological relationship to the recipient was associated with lower risks; however, the majority of donors are related.5 Donors with diabetes mellitus were at very high added risks of ESRD and death The model did not include multiple stages of CKD. A more complex model could have been generated to differential stages 3a, 3b, 4 and 5 multiplied by three levels of proteinuria. However this would complicate the model and we do not have enough patient-level data to examine this in detail. As noted the absolute loss of life was higher in younger donors but a greater percentage of loss of life in older donors. These result from a fixed relative risk of death associated with CKD multiplied by low baseline death rates in the young compared with higher death rates in older subjects along with differences in exposure There is no data on family history of ESRD in the non-biological-related donors. There may be some non-biological-related donors with a family history of kidney disease, which would put them at higher risk. In addition we assumed that the relative risks between white and black of both sexes with a biological relationship were the same. Conclusion Donation reduced life by 1-2% in a 40-year-old donor but this reduction is lower than what is caused by smoking and obesity. In the sub-analysis, the younger population of patients had more life years lost and had a higher risk of developing ESKD. Limitations: The studies included had small numbers and short-term follow-up (around 15y). Donors from US and the control group (non-donor) included international populations. What is the level of evidence provided by this article? Level 2
Hinda Hassan
2 years ago
This study assessed the possible loss of life and the lifetime ESRD cumulative risk from live kidney donation through USA-based Markov model. It included 40-year-old live kidney donors of both sexes and black/white race. The study showed that 1%–5% of average-age current live kidney donors might develop ESRD as a result of nephrectomy. Overall 0.532–0.884 remaining life years were lost from donating a kidney which was equivalent to 1.20%–2.34% of remaining life years. The per cent loss of life attributed to ESRD in relation to total remaining years of life varied between 0.29% for white female and 0.88% for black male. Live kidney donation was associated with an added risk of ESRD especially among those of male sex and black race. Most of the loss of life was predicted to be associated with chronic kidney disease not ESRD. Despite differences in the absolute rates of ESRD in both donors and non-donors, the absolute and per cent loss of life years and QALYs from donation were only modestly lower compared with the base case analysis. Donors were projected to spend 50%–85% more time with an isolated low glomerular filtration rate CKD (CKD not associated with diabetes mellitus or proteinuria) compared with non-donors. More than 50% of all ESRD events in donors occurred 25 years or more after donation. Smoking and obesity reduced life expectancy and increased overall lifetime risks of ESRD in non-donors. However the percentage loss of remaining life years from donation was not very different in those with or without these risk factors.
level of evidence is II
Jamila Elamouri
2 years ago
Lifetime risks of kidney donation: a medical decision analysis
A meticulous selection of donors decreases the long-term donor risk. Aim of the study: it is to determine the potential loss of life in years and the risk of ESRD after live kidney donation. Method:
The study group were 40 years old patients of both gender and white and black race from the USA with median age 38 yrs, and for whom there are recently published estimates of 15 yrs cumulative risk of ESRD in non-donor and donors. Results:
The percent of life loss in black males was more. Percent of life loss varied between white female (1.20%) and black male (2.34%).
Risk of ESRD was higher in black males.
Accumulative risk of ESRD was higher in black males. Diabetic donors at higher risk of ESRD.
Because of longer exposure to reduced kidney function in younger age donors, they are at higher risk of ESRD. As well, they have high potential years of life loss. Conclusion:
Kidney donation may reduce life expectancy by about 0.5 – 1 year. ESRD is one of the risk of kidney donation. Follow up of the donors and modification of the risk factors aggressively is of paramount important to prevent ESRD
level II
Ahmed Omran
2 years ago
A retrospective cohort study – level IIb.
A model called Markov medical decision analysis was implemented using American position at age 40 including gender or ethnicity. The aim of the study is to define whether there is a difference in the prognosis of living donors with nephrectomy based on sex or ethnicity. The main objectives were to estimate years of potential life lost, adjusted loss of lost years, and cumulative risk of ESRD.
The analysis was done in comparison with a population with the same characteristics as the donor, with the healthy behavior of a potential donor.
The results showed that the difference in survival only occurred after 20 years following donation. Men of black ethnicity had the worst rates of survival, considering QUALYs. The same applies with ESRD, where most cases occurred within 25 years or more of donation.
Even in different sexes, black women (1.74%) are at higher risk compared with white men (1.39%) when compared to black men (1.9%). Young people were at higher risk of donation. Diabetes & smoking are other risk factors, DM being the worst. Obesity may have some related impact, but it is inferior to DM &smoking.
This study showed that the loss of life ranges from 1 to 2%, being more related to CKD but not end-stage renal disease. These risks were different depending on ethnicity ;whites 1 in 28 / blacks 1 in 22. This study recommended smoking cessation with weight loss in those with a BMI greater than 30.
Hamdy Hegazy
2 years ago
Please summarize this article in your own words The aim of this study is to estimate the potential loss of life years, quality adjusted life years (QALY) and life time risk of ESRD in living kidney donors.
Study group: Live kidney donors aged 40, black and white race of both sexes in the USA published studies that showed 15 years cumulative risks of ESRD in donors and non-donors. Study population was derived from previously published studies.
Methods: USA theoretical model for risk of ESRD in donors and non-donors include the following assumptions: 1- Donors have higher ESRD rate than non-donors. 2- ESRD is associated with higher mortality in both groups. 3- Nephrectomy will reduce overall patient kidney function. 4- Donors will have a higher risk of dropping GFR below 60 ml/min/m2. 5- Donors are assumed to be free of HTN, DM and proteinuria at the time of donation. 6- CKD will be associated with higher mortality rate in the general population.
Ethical approval: was not required in this study because there was no patient recruitment or patient input.
Outcomes: 1- Remaining years of life. 2- Life years were scaled by measures of quality and discounted at a 3% rate of time preference to calculate QALYs. 3- Calculated lifetime cumulative incidence of ESRD.
Results: Donor/non-donors 15 years cumulative ESRD risks for: White Male: 0.34%/0.067%, White Female: 0.15%/0.045%.
Black Male: 0.96% /0.21%, Black Female: 0.59% /0.12%. 50% of all ESRD events in donors happened 25 years or more post donation. Younger donors lost more years of life especially donors with DM. Donation shortens life by 1-2% especially with smokers and those with high BMI.
Strengths: 1- This study predicts the long-term risks of kidney donation in terms of loss of life, and risk of ESRD. 2- Lifelong follow up in donors can be quantified and the risks can be informed to the donors. 3- Evidence from 15 years follow up in donors compared to healthy population.
Limitations: 1- Using data regarding previous mortality and disease incidence to predict future lifetime. 2- Data from USA donors not international population. 3- They didn’t include different stages of CKD. 4- The study used observed rates of ESRD over 15 years in actual donors compared with theoretical matched cohort. 5- Paradoxes.
What is the level of evidence provided by this article? Level III, retrospective study.
Ahmed Fouad Omar
2 years ago
Introduction:
Patients who donate a kidney may be at greater risk (previously thought to be minimal) of developing CKD and decreased eGFR. However, recent reports show that donation may be associated with increase in risk of ESRD and cardiovascular mortality.
Aim of the study:
To estimate the potential loss of life and the cumulative lifetime risk of ESRD from living kidney donation. Methods:
Participants of 40-year-old live kidney donors of both sexes and black/white race.
Intervention: Live donor nephrectomy.
Design: A USA-based Markov model was used to examine the risk of ESRD in a population of
non-donors and donors.
All analyses compared outcomes of the same population of healthy potential donors and modeled the effects if all donated.
Primary outcomes: the net difference in remaining life years, QALYs and development of ESRD. Results:
Living kidney donation was associated with an added risk of ESRD especially among those of male sex and black race. More than 50% of all ESRD events in donors occurred ≥ 25 years after donation. The younger age, smoking and diabetic donors suffered the greatest loss of life years and have increased risk of ESRD (Most of the loss of life was predicted to be associated with CKD, not ESRD).
Donation shortens life in average-age donors by about 1%–2%. The loss of life from live kidney donation is projected to be far less than smoking or mild obesity Limitations:
The studies included had small numbers and short-term follow-up (around 15y).
Analysis was on US donors but international population was included in non-donor controls.
The model didn’t include multiple stages of CKD. Conclusion:
Live kidney donation may reduce life expectancy by 0.5–1 year in most donors.
Live kidney donation was associated with an added risk of ESRD especially among those of male sex and black race.
Risk factors should be treated aggressively to prevent ESRD and to improve donor survival.
What is the level of evidence provided by this article?
Level 2 (retrospective cohort study).
Ahmed Abd El Razek
2 years ago
Introduction
In the past, renal donation was considered to be clear from any donor risk regarding ESRD and renal impairment. Previous studies concluded that the risk of renal impairment was similar to general population until repeated studies with different
parameters involved revealed different results.
Recent studies evaluated the probable risk of ESRD in 15 year interval in potential non-donors to aid counselling patients who think of donation. Individuals with minimal medical abnormalities particularly black race males are of higher 15-year and lifetime risk of ESRD.
The aim of this study is to demonstrate the expected potential loss of life in addition to the lifetime risk of ESRD in average-risk renal donors.
Methods
Cohorts were 40-year-old patients of both sexes and white/black race from the USA. Mean age of live donors’ is average 38 years. Recent estimates of 15-year cumulative risks of ESRD in non-donors and donors are available.
The main outcome of the study is to identify the expected remaining years of life as quality of life is decreased by development of ESRD and other medical comorbidities. Life years were scaled by measures of quality as well as discounted at a 3% rate of time preference to calculate QALYs. Lifetime cumulative incidence of ESRD was also included.
Non-donors were assumed to have 15-year cumulative ESRD risks of 0.067%, 0.045%, 0.21% and 0.12% for white male, white female, black male and black female, respectively.‘Ideal’ non-donors were assigned lower incidence rates of diabetes mellitus, proteinuria and rates of transition to CKD to match projected lifetime ESRD risks rather than calibrating to 15-year ESRD risks.
Donors were assumed to have 15-year cumulative ESRD risks of 0.34%, 0.15%, 0.96% and 0.59% for white male, white female, black male and black female, respectively.
The elapsed time in case of isolated CKD (no proteinuria nor diabetes mellitus) in donors versus non-donors was not associated with further increase in mortality.
Age of donation, smoking habit, higher BMI, new-onset DM and biological relation to recipients were important points.
Results
Differences in survival among the cohorts became significant 20 years or more following donation.
The expected remaining life years lost from donation average 0.532 years for white female versus 0.884 years for black female donors.
The highest percent loss of life was found in black male donors. The percent loss of life ranged from 1.20% for white female to 2.34% for black male. The per cent loss of total QALYs estimated by 0.76% for white female while 1.51% for black male.
There was added risk of ESRD in living renal donors particularly in males and black race. The expected lifetime cumulative risk of ESRD average 1.135% in white female while 4.645% in black male.
More than 50% of all ESRD cases in donors occurred 25 years or more post renal donation which was significantly earlier in black male than white male. The loss of life percentage due to ESRD in relation to total remaining years of life estimated by 0.29% for white female and 0.88% for black male.
Donors were proposed to have 50%–85% more time isolated low glomerular filtration rate CKD. The expected loss of remaining life years was 0.551, 0.316, 0.682 and0.721 for white male, white female, black male and black female, successively.
Concluding that loss of remaining life years percentage is 1.39%, 0.72%, 1.9% and 1.74% for white male, white female, black male and black female, orderly.
Younger patients tend to lose more potential years of life with potentially more risks of ESRD owing to the longer exposure to reduced renal function. Contrastly, loss of life was significant in older donors when compared to younger donors. Also, life expectancy was reduced in smokers, DM donors as well as obese donors with lesser extent.
Non-biologically related donors were found to have much lower loss of life years as well as risk of ESRD in comparison to biologically related donors.
Discussion
This study elaborates that post renal donation potentially shortens life in average-age donors by 1%–2%. Also highlights that short-term studies less than 20 years even with appropriate normal controls can’t be satisfactory in detecting adverse effects regarding survival. ESRD is associated with very high mortality rates according to this study with significant loss of life percentage was not only associated with ESRD but with CKD as well. Smoking, obesity and biological relationship to the recipient were also addressed as risk factors for development of ESRD and mortality as stated by this study.
Previous studies have rather short-term follow-up interval. So, clear discrepancies were found later when the cumulative effects of CKD were more obvious. Even more, differences are evident in race and sex. Results showed that 78% of the loss of all QALYs post donation was obtained with CKD in white female versus 58% in black male. Guided by risk factors detected as hypertension, diabetes mellitus and other comorbidities, appropriate intervention can further prevent ESRD and improve donor survival.
Longer term studies lately have revealed that some donors might develop diabetes mellitus and hypertension, despite being absent at the time of donation, which can be subsequently responsible for ESRD development. The lifetime added risk of ESRD was found to be lower, that is why the overall predicted absolute loss of life associated was not that different.
The risk of development of ESRD in white male seems to be accelerated after 25–30 years of follow-up. This can be explained by the longer life expectancies.
The expected loss of life from post living renal donation was found to be far less than smoking or mild obesity. Counselling and interventions to reduce weight and smoking cessation are more important for both donor and non-donor. Non-biological relations were associated with lower risks.
One of the limitations of the study was involving analysis of US donors, whereas the non-donor control population involved all US and international populations. The model also did not include multiple stages of CKD owing to lack of patient-level data. The cohort used 40-year-old individuals as baseline analysis, but the information available was from cohort of wide range donors.
Some paradoxes in the analysis were astonishing, as the increased relative mortality risks associated with CKD, however the overall estimates of life loss associated with donation are between 0.5 and 1 year. Also the absolute loss of life was higher in younger donors but a greater percentage of loss of life in older donors. Besides data concerning family history of ESRD in the non-biological-related donors were unavailable. Assumption that the relative risks between white and black of both sexes with a biological relationship were the same was not totally correct.
Thus, follow up the donors and treating risk factors aggressively to prevent ESRD and to improve donor survival is recommended.
Level of evidence is II.
Amna Khalifa
2 years ago
1. Please summarise this article in your own words The study was meant to estimate the potential loss of life and added life time risk of ESRD in average risk kidney donors using a USA -based Markov model. The mean age of the participant was 40. The results showed that 1-5% of average- age current live kidney donors might develop ESRD as a result of nephrectomy, the added risk of ESRD resulted in a loss of 0.126-0.344 remaining life years, most of the loss was predicted due to CKD not ESRD. Most events occurred after 25 yrs of donation. They also found out that smoking and obesity were among reducing factors in non donors. The percentage loss of remaining life years from donation was not very different in those with or without these risk factors. The author concluded that these results confirms the importance of following the donors and identifying and treating the risk factors to prevent ESRD and improve donor survival. 2. What is the level of evidence provided by this article? Level 3
rindhabibgmail-com
2 years ago
This study was done basically to estimate the probable life time risk of CKD/ESRD.
It was done on patients who had nephrectomy with eGFR >60ml/min before proceeding to surgery. this study was solely dependent on previous studies.
To state that in conclusion there is increased risk of ESRD in donors compared to non- donors which reduces life expectancy by 0.5 to 1 year. The donors will be having greater risk of falling eGFR compared with non- donors.
Level of evidence II.
Rehab Fahmy
2 years ago
It is important issue is to council people willing for kidney donation regarding risks of donation of their kidney and long term outcomes
This study aims at estimatation of 1- the potential loss of life and 2- the added lifetime risk of ESRD in average-risk kidney donors.
Methods: USA-based Markov model was used to examine the risk of ESRD in a population of non-donors and donors.
Study relies on previously published data and there was no recruitment of patients to the study
Patients are 40 year-old patients of both sexes and white/black race from the USA.all donors has unilateral nephrectomy .followed up for 15 years.
Outcome:measuring remaining years of life and incidence of ESRD
Results: 1-,the remaining life years lost from donation ranged between 0.532 years for white female and 0.884 years for black female donors. The per cent loss of life was highest in black male donors. The per cent loss of life varied from 1.20% for white female to 2.34% for black male. The per cent loss of total QALYs varied from 0.76% for white female to 1.51% for black male.
2- Live kidney donation was associated with an added risk of ESRD especially among those of male sex and black race. The added lifetime cumulative risk of ESRD varied from 1.135% in white female to 4.645% in black male .This translated to one added ESRD event for every 88 white female donors or one added ESRD event for every 22 black male donors.
3-Donors were projected to spend 50%–85%more time with an isolated low glomerular filtration rate CKD (CKD not associated with diabetes mellitus or proteinuria) compared with non-donors. Assuming the added propor- tion of time spent with isolated low glomerular filtration rate CKD had no increase in all-cause mortality rate, the loss of remaining life years was 0.551, 0.316, 0.682 and 0.721 for white male, white female, black male and black female, respectively. This corresponded to an overall per cent loss of remaining life years of 1.39%, 0.72%, 1.9% and 1.74% for white male, white female, black male and black female, respectively.
4-younger patients lost more potential years of life and had potentially greater risks of ESRD given longer exposure to reduced kidney function.However on a percentage basis, loss of life was greater in older compared with younger donors.
5-Life expectancies were markedly reduced and lifetime risks of ESRD increased for cohorts who were smokers or had diabetes mellitus.
6-Obese patients were also at increased risk but less so compared with smokers and those with diabetes mellitus.
7- Surprisingly the absolute loss of life years was slightly less in donors who were obese or smoked compared with donors without these conditions.
8- Donors with diabetes mellitus suffered the greatest loss of life years and increased risk of ESRD.
9-Non-biological relationship to the recipient was associated with much lower loss of life years and risk of ESRD compared with those who were biologically related .
Disscusion :
In this study they show that donation potentially shortens life in aver- age-age donors by about 1%–2%. This analysis shows that short-term studies (<20 years) even with appropriate normal controls are not likely to detect an adverse effect on survival. Although ESRD is associated with very high mortality rates, a significant per cent of the loss of life was associated with CKD not ESRD. The study also explored risk factors that can be associated with higher rates of death and ESRD such as smoking, obesity and biological relationship to the recipient.
The analysis suggests that counselling and inter- ventions to reduce weight and smoking cessation are more important to both donor and non-donor and less of an argument to deny donation. Having a non-biological rela- tionship to the recipient was associated with lower risks; however, the majority of donors are related.5 Donors with diabetes mellitus were at very high added risks of ESRD and death.
Limitations to the study:
1-They used data from ESRD over 15 years in actual donors and a theoretical matched cohort to calculate lifetime outcomes.11 Life expectancy and the cumulative incidences of diabetes mellitus and ESRD are increasing. Using historic mortality and disease incidence rates to make accurate future lifetime projections is a significant limitation.
2-The study was an analysis of US donors, whereas the non-donor control population included US and international population.
3-did not include multiple stages of CKD.
4-the overall estimates of life loss associated with donation are between 0.5 and 1 year. There however appear to be some paradoxes in the analysis. As noted the absolute loss of life was higher in younger donors but a greater percentage of loss of life in older donors and they were not included.
5-The absolute loss of life years was less in obese and smoking donors than in otherwise ideal donors largely because the overall remaining life years were much shorter in donors with these risks.
6-No data on family history of ESRD in the non-biological-related donors. There may be some non-biological-related donors with a family history of kidney disease, which would put them at higher risk.
Conclusion:
Live kidney donation may reduce life expectancy by 0.5–1 year in most donors.
A lot of risk factors may affect life expectancy rather than ESRD ,following donors is essential step to avoid any preventable risk factor or to control any risk factors that may lead to ESRD like -ost donation DM ,HTN.
One of the most important question that we will face in transplantation center is what is the long term out come of kidney donation ? what is the risk of having ESRD or even life span expectancy ?
So this study was found to estimate the potential loss of life as well as the added lifetime risk of ESRD in average risk kidney donor
Method
the USA based Markov model was used to explore the risk of ESRD among donors and non-donor with some assumptions on the rate of CKD, ESRD, and CVD
the study depends solely on previous published studies
Participants 40-year-old live kidney donors of both sexes and black/white race.
Follow up for 15 year
donors in the study had nephrectomy done that is belief to have effect on GFR that was usually > 60mil/min before surgery
the annual transition rate for proteinuria, hypertension and DMN based on age, sex, gender, race was empirically derived
Conclusion
ESRD rates are increased in donors compared with non-donors especially among those of male sex and black race
transition through a CKD state for at least 1 year before developing ESRD.
Live kidney donation may reduce life expectancy by 0.5–1 year in most donors.
The development of ESRD in donors may not be the only measure of risk as most of the predicted loss of life predates ESRD.
The study identifies the potential importance of following donors and treating risk factors aggressively to prevent ESRD and to improve donor survival.
ollowing are the key assumptions for the model:
ESRD in both donors and non-donors will be associated with high mortality rates.
donors will have a greater risk of falling below a GFR threshold of 60 mL/min/1.73 m2 compared with non-donors.
risk of developing hypertension- DM- proteinuria whether they donate or not, and these will impact patient survival and loss of kidney function in both donor and non donors
level of evidence : 2
Shereen Yousef
2 years ago
▪︎Summary of the article -This study was done to determine the potential loss of life in years and risk of end-ESRD from live kidney donation.
-risks to the donors are felt to be small to moderate,and proper screening and selection of donors decreases the long term donors risk.
-But still there is some reports showed that kidney donors are at risk of increase incidence of end-stage renal disease , and increase in cardiovascular mortality. -donors also become at risk of developing chronic kidney disease (CKD) as defined as low GFR of <60mL/ min/1.73m2 or proteinuria. – it was found also that some donors devoloped DM and may be at higher risk of developing hypertension.
▪︎Target cases were 40-year-old patients of both sexes and white/black race from the USA,mean age of live donors (median age 38) .
▪︎Results: -percent loss of life was highest in black male donors. -percent loss of life varied from 1.20% for white female to 2.34% for black male. – percent loss of total QALYs varied from 0.76% for white female to 1.51% for black male. –risk of ESRD was higher in male sex and black race.
-added lifetime cumulative risk of ESRD varied from 1.135% in white female to 4.645% in black male.
– younger patients lost more potential years of life and had potentially greater risks of ESRD given longer exposure to reduced kidney function.
-donors with DM had greater risk of ESRD.
▪︎Strength of the study
The study reports long-term risk of donation including loss of life and the added risk of end-stage renal failure.
These findings help to declare risk to donors and convey the importance of lifelong follow-up in actual donors.
The study uses evidence of over 15 years of follow up in actual live kidney donors and healthy controls.
▪︎limitations of the study
-rely on the observed rates of ESRD over 15 years in actual donors and a theoretical matched cohort to calculate lifetime outcomes.
-analysis of US donors, and the non-donor control group included US and international populations.
-model did not include multiple stages of CKD.
–using a uniform cohort of 40-year-old individuals in the baseline analysis, whereas the information available is from a cohort of donors with a wide range of ages.
▪︎Conclusion
-Live kidney donation may reduce life expectancy by 0.5–1year in most donors. -ESRD in donors is not the only measure of risk. – most of life loss happened before reaching ESRD. -longer follow up of donors and treating risk factors aggressively is very important to prevent ESRD and to improve donor survival.
Cohort study level of evidence II
Hussam Juda
2 years ago
· Recent reports indicated that donation may increase the risk of ESKD and cardiovascular mortality
· Some donors may develop DM or HTN in spite of being screened before donation, which increases the risk of CKD and resultant ESKD
· The aim of this study is to estimate the potential loss of life as well as the added lifetime risk of ESRD in average-risk kidney donors
Methods
· A USA-based Markov model was used to examine the risk of ESRD in a population of non-donors and donors
· A previously published studies was updated to include recent general population and ESRD vital statistics, and recent cumulative risks of DM, CKD and ESRD from published sources
· There
· were no involved patients in the study
Target population
· 40-year-old patients of both sexes and white/black race from the USA. This is the mean age of live donors (median age 38) and for whom there are recent published estimates of 15-year cumulative risks of ESRD in non-donors and donors
Results
· The donation leads to loss of 0.532 years for white female and 0.884 years for black female donors.
· The loss of life was highest in black male donors.
· The loss of life varied from 1.20% for white female to 2.34% for black male.
· The loss of total QALYs varied from 0.76% for white female to 1.51% for black male
· The added lifetime cumulative risk of ESRD varied from 1.135% in white female to 4.645% in black male
· More than 50% of all ESRD events in donors occurred 25 years or more after donation.
· The added ESRD events tended to occur earlier in black male compared with white male
· Donors were estimated to spend 50%–85%more time with an isolated low GFR CKD compared with non-donors
· loss of life was greater in older compared with younger donors
· Unexpectedly, the absolute loss of life years was slightly less in donors who were obese or smoked compared with donors without these conditions
· Donors with DM had the greatest loss of life years and increased risk of ESRD
Strength of the study:
· Estimated the long-term risk of donating a kidney, including loss of life and the added risk of end-stage renal failure.
· The donors may be informed about the results, which hold a risk od donation and the need for follow up post donation
· The study uses evidence of over 15 years of followup in actual live kidney donors and healthy controls. Limitation:
· The ability to predict lifetime outcomes from 15- year follow-up in donors of all ages and medical conditions
· The study was an analysis of US donors, whereas the non-donor control population included US and international populations
· The results could not applicable to live kidney donors from other countries where population ESRD rates are much lower
· The model did not include multiple stages of CKD
CONCLUSION
· Donation potentially shortens life in average-age donors by about 1%–2%
· The affected survival, can not be detected with the short-term studies (<20years)
· Smoking, obesity and biological relationship to the recipient are associated with higher rates of death and ESRD
· Some donors may develop DM, hypertension and proteinuria later on, and these may affect overall survival and progression to ESRD
· To estimate the effect of donation truly, more information is needed, and large numbers of patients and controls and long-term follow-up are needed to estimate with different variables
What is the level of evidence provided by this article?
This is a retrospective cohort study (level III)
Abhijit Patil
2 years ago
Aim: To estimate the potential loss of life as well as the added lifetime risk of ESRD in average- risk kidney donors.
Study design: Markov medical decision analysis
Participants 40-year-old live kidney donors of both sexes
and black/white race in US undergoing live donor nephrectomy
Main outcome and measures Potential remaining life years lost, quality-adjusted life years (QALYs) lost and added lifetime cumulative risk of ESRD from donation.
Results
0.532–0.884 remaining life years were lost from donating a kidney.
This was equivalent to 1.20%–2.34% of remaining life years (or 0.76%–1.51% remaining QALYs).
Risk was higher in male and black donors
1%–5% of current live kidney donors might develop ESRD as a result of nephrectomy.
The added risk of ESRD resulted in a loss of only 0.126–0.344 remaining life years.
Most of the loss of life was predicted to be associated with CKD and most events occurred 25 or more years after donation.
The percentage loss of remaining life years from donation was similar in those with or without smoking and obesity as risk factors.
Conclusion Live kidney donation may reduce life expectancy by 0.5–1 year in most donors.
The donors should be followed up strictly post-donation and the risk factor factors should be treated aggressively to prevent ESRD in them, thus prolonging donor survival.
Limitations:
The study relied on the observed rates of ESRD over 15 years in actual donors and a theoretical matched cohort to calculate lifetime outcomes, future predictions based on this historical data may not be proper.
Donor population was US, while the non-donor was international population
The model did not include multiple stages of CKD.
Non-donors were only 40 years old
Level of evidence: Level II
Muntasir Mohammed
2 years ago
Please summarise this article in your own words
Introduction Around 30000 kidney donations is done yearly worldwide. The expected benefit is improving survival and quality of life for the recipients. However, there is a risk for the donor although it is small. With post operative mortality of around 3 per 10000 surgeries. On the long term also, the risk is estimated to be low, but some recent reports showed that risk of ESRD is increased. The objectives of this study were to estimate the potential loss of life as well as the added lifetime risk of ESRD in average- risk kidney donors.
Methods Model description A USA-based Markov model was used to examine the risk of ESRD in a population of non-donors and donors. Target population The base case cohorts were 40-year-old patients of both sexes and white/black race from the USA. This is the mean age of live donors (median age 38) and for whom there are recent published estimates of 15-year cumulative risks of ESRD in non-donors and donors.
Main outcome measures The health outcome of interest was remaining years of life.
Intervention effects Donors in the study underwent unilateral nephrectomy. It is assumed that the nephrectomy results in a loss of GFR, and this loss of function would increase the probability of transitioning from a normal (GFR ≥60 mL/min/1.73 m2) kidney function heath state to CKD. Results Differences in survival starts to appear after 20 years or more from donation. The remaining life years lost from donation ranged between 0.532 years for white female to 0.884 years for black female donors. The per cent loss of life was highest in black male donors. The per cent loss of life varied from 1.20% for white female to 2.34% for black male. The per cent loss of total QALYs varied from 0.76% for white female to 1.51% for black male. Those with diabetes has more loss than others. The added lifetime cumulative risk of ESRD varied from 1.135% in white female to 4.645% in black male. This translated to one added ESRD event for every 88 white female donors or one added ESRD event for every 22 black male donors. Discussion This study showed that the remaining life lost because of donation range from 1-2%. It is higher in black male and lowest in white female. If we compared this with life lost due to smoking and mild obesity the late are costing more. Compared with live part of liver donation, despite higher perioperative mortality in liver donation 1.7 per 1000 versus 0.31 per 1000 kidney donations, there is no long-term life loss in the liver donors. This study also highlighted the importance of long time follow up, as the risk of CKD and ESRD appears after 25years. This means that studies with shorter duration will easily missed this risk. Limitations 1. Limitation of modelling future events. 2. We rely on the observed rates of ESRD over 15 years in actual donors and a theoretical matched cohort to calculate lifetime outcomes. 3. Life expectancy and the cumulative incidences of diabetes mellitus and ESRD are increasing. 4. Using historic mortality and disease incidence rates to make accurate future lifetime projections. however, 5. The study was an analysis of US donors, whereas the non-donor control population included US and international populations.
What is the level of evidence provided by this article?
Level 11
Zahid Nabi
2 years ago
The most important question asked by donors is always what is my life time risk of developing kidney disease?
Kiberd and Tennankore have tried to answer this question by conducting this study to estimate the potential loss of life and the lifetime cumulative risk of end-stage renal disease (ESRD) from live kidney donation by using Markov medical decision analysis.
The study was conducted in USA and 40-year-old live kidney donors of both sexes and black/white race were included.
Main outcome and measures were Potential remaining life years lost
quality-adjusted life years (QALYs) lost and
added lifetime cumulative risk of ESRD from donation.
The following are the key assumptions for the model:
ESRD rates are increased in donors compared with non-donors.
ESRD in both donors and non-donors will be associated with high mortality rates.
Nephrectomy in donors will quantitatively reduce overall patient kidney function.
Cohorts are assumed to be free of hypertension, diabetes mellitus and proteinuria at donation.
CKD states will be associated with higher mortality rates as in the general population.
In this study they show that donation potentially shortens life in average-age donors by about 1%–2%.
This analysis shows that short-term studies (<20 years) even with appropriate normal controls are not likely to detect an adverse effect on survival.
Based on current literature it is unclear whether there is a significant risk of death from donation
Live kidney donation may reduce life expectancy by 0.5–1 year in most donors.
The development of ESRD in donors may not be the only measure of risk as most of the predicted loss of life predates ESRD.
The study identifies the potential importance of following donors and treating risk factors aggressively to prevent ESRD and to improve donor survival.
Retrospective study
level 2
Ghalia sawaf
2 years ago
The aim of this study is to demonstrate the living donor’s:
1- potential loss of life
2- loss of lifetime cumulative risk of ESRD
this study follows the Makov medical decision analysis design
following are the key assumptions for the model:
ESRD rates are increased in donors compared with non-donors
ESRD in both donors and non-donors will be associated with high mortality rates.
transition through a CKD state for at least 1 year before developing ESRD.
donors will have a greater risk of falling below a GFR threshold of 60 mL/min/1.73 m2 compared with non-donors.
risk of developing hypertension- DM- proteinuria whether they donate or not, and these will impact patient survival and loss of kidney function in both donor and non donor
Results;
Differences in survival between the cohorts became apparent after 20 year
The per cent loss of total QALYs varied from 0.76% for white female to 1.51% for black male.
Live kidney donation was associated with an added risk of ESRD especially among those of male sex and black race.
The per cent loss of life attributed to ESRD in relation to total remaining years of life varied between 0.29% for white female and 0.88% for black male
Assuming the added proportion of time spent with isolated low GFR CKD had no increase in all-cause mortality rate
younger patients lost more potential years of life and had potentially greater risks of ESRD given longer exposure to reduced kidney function.
However on a percentage basis, loss of life was greater in older compared with younger donors.
lifetime risks of ESRD increased for cohorts who were smokers or had diabetes mellitus.
Obese patients were also at increased risk but lesser
Non-biological relationship to the recipient was associated with much lower loss of life years and risk of ESRD compared with those who were biologically related.
Conclusion
Asking donors whether they may be willing to give up between 0.5 and 1 year of life may be a better way to convey risk than giving them an estimate of their lifetime risk of ESRD.
In addition the study identifies the potential importance of following donors and treating risk factors aggressively to prevent ESRD and to improve donor survival
limitation of this study
The ability to predict lifetime outcomes from 15year follow-up in donors of all ages and medical conditions is a limitation.
Level of evidence is 2
Filipe prohaska Batista
2 years ago
This is a retrospective cohort study – level IIb.
It used a model called Markov medical decision analysis using the American position at age 40 including gender or ethnicity. The intention of the study is to define whether there is a difference in the prognosis of living donors who underwent nephrectomy based on sex or ethnicity. The main objectives were to assess years of potential life lost, adjusted loss of years lost, and cumulative risk of end-stage renal disease.
The analysis was performed in comparison with a population with the same characteristics as the donor, having the healthy behavior of a potential donor.
The results showed that the difference in survival in the cohorts only occurred after 20 years after donation. Men of black ethnicity had the worst survival rates, including considering QUALYs. The same occurs with ESRD, where most cases occurred within 25 years or more of donation.
Even in different sexes, black women (1.74%) are at higher risk than white men (1.39%) when compared to black men (1.9%). In other analyses, young people were at greater risk of donating. Diabetes and smoking are other risk factors, the former being the worst. Obesity may have some related potential, but it is inferior to the previous two.
This study showed that the loss of life potential ranges from 1 to 2%, being more related to chronic kidney disease and not end-stage renal disease. These risks were different depending on ethnicity (whites 1 in 28 / blacks 1 in 22). This study suggests smoking cessation associated with weight loss in those with a BMI greater than 30.
Mohamed Ghanem
2 years ago
Introduction
There is a very low risk of developing CKD in kidney donors may be due to the risk of developing hypertension, DM, and proteinuria which may affect the remained kidney.
Target population
40-year-old patients ( males and females ) (black and white ) with median age 38 years old. Study Design and outcome:
Study of the rate of developing ESKD in both groups (donor and non-donors) in addition to studying of loss of life after developing ESKD in different groups and rate of developing of DM, HTN, and proteinuria and effect on CKD progression.
15 years risk of development of ESKD in non-donor groups were Respectively :
0.067%, 0.045%, 0.21% and 0.12% for white male, white female, black male and black female.
15 years risk of development of ESKD in donor groups were Respectively :
0.34%, 0.15%, 0.96% and 0.59% for white male, white female, black male and black female . Results :
The percent of life loss was the highest among the black male donors of 2.34% and the least among white female donors 0.532 years.
Increase the risk of ESKD on black male donors 4.645% and 1.135% for white female donor
More than 50 % of ESKD occurs after 25 years of kidney donation.
Young donors were more exposed to ESKD and more life loss due to long-time exposure with less glomerular filtration rates.
Diabetic donors had the highest risk for developing ESKD with more loss of life after ESKD.
Discussion :
Kidney nephrectomy of Donors decreases life in average-age donors by an average ( 1%–2%).
The risk of ESKD and death was higher with these risk factors (DM, Obesity, and Biological relationship with recipients )
CKD was associated with an increased risk of death mostly due to increased risk of cardiovascular disease and longer time till progression to ESKD.
Life lost from CKD was high from a life lost on ESKD.
This may be due to the probability of DM, Proteinuria, Obesity, and hypertension affecting the donors which increase the rate of cardiovascular and ESKD and even may the highest risk of progression of ESKD in both donors and non–donors.
Counseling for Both decreasing weight and stopping of smoking is very important for both groups to decrease the risk of CKD.
Non- biological relationships of donors were associated with fewer risk factors for ESKD. Limitations of the study :
donors were from the US however non-donors were from the Us and International.
The observation period was 15 years and a theortical-matched study was used to calculate lifetime
The model didn’t include different stages of CKD.
Level of evidence II
Huda Saadeddin
2 years ago
Life expectancy is associated with ESRD development and the increase of cardiovascular diseases
The study showed that 1%–5% of average-age current live kidney donors might develop ESRD as a result of nephrectomy. The added risk of ESRD resulted in a loss of only 0.126–0.344 remaining life years. Most of the loss of life was predicted to be associated with chronic kidney disease (CKD) not ESRD. Most events occurred 25 or more years after donation. Reducing the increased risk of death associated with CKD had a modest overall effect on the per cent loss of remaining life years (0.72%–1.9%) and QALYs (0.58%–1.33%).
However the percentage loss of remaining life years from donation was not very different in those with or without these risk factors.
conclusion
Live kidney donation may reduce life expectancy by 0.5–1 year in most donors. The development of ESRD in donors may not be the only measure of risk as most of the predicted loss of life predates ESRD. The study identifies the potential importance of following donors and treating risk factors aggressively to prevent ESRD and to improve donor survival.
Recent reports however show that there is some increase in risk of end-stage renal disease (ESRD) from donation and possibly an increase in cardiovascular mortality. 5 6 Patients who donate a kidney may be at greater risk of developing chronic kidney disease (CKD) as defined by a low glomerular filtration rate (GFR) of <60 mL/ min/1.73 m 2 or proteinuria. 7 Furthermore, some donors will develop diabetes mellitus at a later date despite being screened and may be at higher risk of developing hypertension. 8 9 These conditions could accelerate the loss of kidney function and increase the risk of ESRD. CKD is associated with an increase in risk of progression to ESRD and an increase in predialysis mortality.
Recent reports however show that there is some increase in risk of end-stage renal disease (ESRD) from donation and possibly an increase in cardiovascular mortality. 5 6 Patients who donate a kidney may be at greater risk of developing chronic kidney disease (CKD) as defined by a low glomerular filtration rate (GFR) of <60 mL/ min/1.73 m 2 or proteinuria. 7 Furthermore, some donors will develop diabetes mellitus at a later date despite being screened and may be at higher risk of developing hypertension. 8 9 These conditions could accelerate the loss of kidney function and increase the risk of ESRD. CKD is associated with an increase in risk of progression to ESRD and an increase in predialysis mortality.
MethODs
Model description
The following are the key assumptions for the model: ► ESRD rates are increased in donors compared with non-donors.11
► ESRD in both donors and non-donors will be associated with high mortality rates.
► Donor and non-donors transition through a CKD state for at least 1 year before developing ESRD.
► Since ESRD rates are increased in donors compared with non-donors, we assumed there must have been an increase in the rate of transition to and time spent in CKD states.
► Nephrectomy in donors will quantitatively reduce overall patient kidney function. Given that kidney function declines over time in most individuals, donors will have a greater risk of falling below a GFR threshold of 60 mL/min/1.73 m 2 compared with non-donors.
► Cohorts are assumed to be free of hypertension, diabetes mellitus and proteinuria at donation. However they are at risk of developing these conditions whether they donate or not, and these will impact patient survival and loss of kidney function in both donors and non-donors.
uncertainty and sensitivity analyses
We assumed that many future risks that can impact on life expectancy and ESRD such as cancer, obesity, smoking and so on were not influenced by the act of kidney donation. The lifetime estimates of ESRD were found to be higher in non-donors than published estimates, in part since this model incorporated the possibility that some participants could develop diabetes mellitus and proteinuria.
In other sensitivity analyses age at donation, smoking status, higher body mass index, new-onset diabetes mellitus and biological relationship to recipient were explored.
results
Baseline analysis
Differences in survival between the cohorts became apparent after 20 years or more after donation.
The per cent loss of life varied from 1.20% for white female to 2.34% for black male. The per cent loss of total QALYs varied from 0.76% for white female to 1.51% for black male.
Live kidney donation was associated with an added risk of ESRD especially among those of male sex and black race.
More than 50% of all ESRD events in donors occurred 25 years or more after donation.
In a variety of subgroup analyses younger patients lost more potential years of life and had potentially greater risks of ESRD given longer exposure to reduced kidney function.
Surprisingly the absolute loss of life years was slightly less in donors who were obese or smoked compared with donors without these conditions. Donors with diabetes mellitus suffered the greatest loss of life years and increased risk of ESRD.
The mechanism by which low glomerular filtration rate CKD is associated with an increase in cardiovascular and all-cause mortality rate is not completely known.
Level II
Dalia Ali
2 years ago
Introduction
The risks to the donors are generally felt to be small to modest, with a low postoperative mortality (approximately 3.1 deaths per 10 000 operations)
The long-term risks are also presumed to be small especially in low-risk donors who are adequately screened.
Patients who donate a kidney may be at greater risk of developing chronic kidney disease (CKD) as defined by a low glomerular filtration rate (GFR) of <60 mL/ min/1.73 m2 or proteinuria.
Furthermore, some donors will develop diabetes mellitus at a later date despite being screened and may be at higher risk of developing hypertension.
These conditions could accelerate the loss of kidney function and increase the risk of ESRD. CKD is associated with an increase in risk of progression to ESRD and an increase in predialysis mortality.
Those with minor medical abnormalities, men and individuals of black race had greater 15-year and lifetime risks of ESRD.
Methods Model description
A USA-based Markov model was used to examine the risk of ESRD in a population of non-donors and donors.
Patient involvement in study design
The study design, development and research question did not involve patient input, nor were outcomes informed
by patient priorities. There was no patient recruitment or participation in this study but rather the study relied on prior published analyses.
Target population
The base case cohorts were 40-year-old patients of both sexes and white/black race from the USA. This is the mean age of live donors (median age 38) and for whom there are recent published estimates of 15-year cumulative risks of ESRD in non-donors and donors.
Intervention effects
Donors in the study underwent unilateral nephrectomy. It is assumed that the nephrectomy results in a loss of GFR, and this loss of function would increase the probability of transitioning from a normal (GFR ≥60 mL/min/1.73 m2) kidney function heath state to CKD. Results and discussion
this study show that donation potentially shortens life in average-age donors by about 1%–2%. This analysis shows that short-term studies (<20 years) even with appropriate normal controls are not likely to detect an adverse effect on survival.
The study also explored risk factors that can be associated with higher rates of death and ESRD such as smoking, obesity and biological relationship to the recipient. The mechanism by which low glomerular filtration rate CKD is associated with an increase in cardiovascular and all-cause mortality rate is not completely known. Based on current literature it is unclear whether there is a significant risk of death from donation, but studies have had relatively small numbers, only 0.2% lower than a non-donor
This model incorporated the probability that some donors will develop diabetes mellitus, hypertension and proteinuria at a later date, and these would impact on health (overall survival and progression to ESRD) as they do in the general population. The model could have been simplified if these risk factors for CKD and ESRD were not included in the model, but this would not reflect reality.
The baseline analysis also showed that white males suffer greater added long-term ESRD risks from donation than would be anticipated. For white male the added risk of an ESRD event was 1 for every 28 donors. For black male the risk was 1 in 22. One would have expected the added risk of ESRD in white male to be less than half the added risk in black male from what is known in the general population
The analysis suggests that counselling and interventions to reduce weight and smoking cessation are more important to both donor and non-donor and less of an argument to deny donation. Having a non-biological relationship to the recipient was associated with lower risks; however, the majority of donors are related.5 Donors with diabetes mellitus were at very high added risks of ESRD and death
The model did not include multiple stages of CKD. A more complex model could have been generated to differential stages 3a, 3b, 4 and 5 multiplied by three levels of proteinuria. However this would complicate the model and we do not have enough patient-level data to examine this in detail.
As noted the absolute loss of life was higher in younger donors but a greater percentage of loss of life in older donors. These result from a fixed relative risk of death associated with CKD multiplied by low baseline death rates in the young compared with higher death rates in older subjects along with differences in exposure
There is no data on family history of ESRD in the non-biological-related donors. There may be some non-biological-related donors with a family history of kidney disease, which would put them at higher risk. In addition we assumed that the relative risks between white and black of both sexes with a biological relationship were the same.
Conclusion
More information is required before we can truly estimate the impact of live kidney donation. Given the need for large numbers of patients and controls and long term follow-up, this risk may never be accurately measured for all age, race, sex and those with minor medical abnormalities. Given the above, estimating lifetime ESRD rates in non-donors may not be the best or only metric to inform the risk of donation.11 Greater efforts to put risk into context for potential donors in the face of uncertainty for any one individual donor. Asking donors whether they may be willing to give up between 0.5 and 1 year of life may be a better way to convey risk than giving them an estimate of their lifetime risk of ESRD.
level II
Rihab Elidrisi
2 years ago
In this study found to have increase risk of ckd and ESRD in donor group compare to non donor .
it is also showed increase of multiple risk factors .
This study showed shorten life of to 1 to 2 5 in donor group in to complain to non donor group .
Young age donor is at greater risk of having ESRD
THE LEVEL s cohort level 2
Reem Younis
2 years ago
Please summarise this article in your own words -The recent reports show that there is some increase in risk of end-stage renal disease (ESRD) from donation and possibly an increase in cardiovascular mortality. -Patients who donate a kidney may be at greater risk of developing chronic kidney disease , diabetes mellitus and hypertension. – Donor with minor medical abnormalities, men and individuals of black race had greater 15-year and lifetime risks of ESRD. – objectives of this study were to estimate the potential loss of life as well as the added lifetime risk of ESRD in average- risk kidney donors. – Although ESRD is associated with very high mortality rates, a significant per cent of the loss of life was associated with CKD not ESRD. – The per cent of patients modelled to be alive at 20 years post nephrectomy for an average-age white male donor was only 0.2% lower than a non-donor . – About 78% of the loss of all QALYs from donation was associated with CKD in white female, whereas the loss was 58% in black male. – The baseline analysis showed that white males suffer greater added long-term ESRD risks from donation than would be anticipated. – The loss of life from live kidney donation is projected to be far less than smoking or mild obesity . – The live partial liver donation may be less risky over the long run compared with live kidney donation. -Despite a higher postoperative mortality with partial live liver donation, kidney donation results in more loss of life when adding in the long-term impact. – The life years lost from donation are greater than the life years gained from colorectal cancer screening in an average-risk person. -The younger donors have greater added risks of ESRD and potential life years lost; however, the percentage loss of life was somewhat less compared with older cohorts. -The effect of smoking and diabetes mellitus had large effects on overall survival and in lifetime risks of ESRD in donors and non-donors. The effects were less in obese donors compared with donors who were smoking or had diabetes mellitus. – Donors with diabetes mellitus were at very high added risks of ESRD and death. A40-year-old white female with diabetes mellitus, who is otherwise well, has about the same added risk of ESRD and percentage loss of life years as a current ideal 40-year-old black male donor. – Since donors eventually have a greater risk of entering into a more advanced CKD state, this analysis may have underestimated the overall net loss of life years from nephrectomy. -There is no data on family history of ESRD in the non-biological-related donors. What is the level of evidence provided by this article? Level 2
The article highlights the long term effects of kidney donation in terms of QALYs lost in predominantly American population. The authors have used strong statistical tools to retrospectively analyse the effects of donation, which scores very well in favour of living kidney donation. The key take home messages would be that long term morbidity and mortality pointers only appear after 20-30 years of follow up and living kidney donations are extremely safe, provided the donors adapt a healthy lifestyle.
This is a very short reply, unless you summarised it in the last week
Anna Gupta
2 years ago
It is an observational retrospective cohort study that has used historical population based control. Donation reduced life by 1-2% which is comparatively less as compared to smoking and obesity. Nonetheless younger donors have increased risk of ESKD
This is a very short reply, unless you summarised it in the last week
Maksuda Begum
2 years ago
Lifetime risks of kidney donation: a medical decision analysis
▪︎The objectives of this study were to estimate the potential loss of life as well as the added lifetime risk of ESRD in average-risk kidney donors.
♧Introduction:
▪︎Patients who donate a kidney have an increase in risk of ESRD, cardiovascular mortality, CKD as defined by a low GFR of <60mL/min/1.73m2 or proteinuria, DM and hypertension.
Methods:
Target population: 40-year-old patients of both sexes and white/black race from the USA.
Intervention: Donors who underwent unilateral nephrectomy.
Design: Markov medical decision analysis.
All analyses compared outcomes of the same population of healthy potential donors and modelled the effects if all donated.
Primary outcomes: the net difference in remaining life years, QALYs and development of ESRD.
Results-
Risk of ESRD is higher in donors as compared to non donors.
Donation can decrease life up to a year- Overall the 1.2-2.3% remaining years were lost.
Most of the loss of life was associated with CKD and not ESRD
The risk is higher in males, blacks, family relatives , if high BMI and smokers.
Most of the events occurred 25 years post donation
Conclusion
Donation reduced life by 1-2% in a 40-year-old donor but this reduction is lower than what is caused by smoking and obesity. In the sub-analysis, the younger population of patients had more life years lost and had a higher risk of developing ESKD.
Limitations:
The studies included had small numbers and short-term follow-up (around 15y).
Donors from US and the control group (non-donor) included international populations.
What is the level of evidence provided by this article?
Cohort study Level 2
Thank you, Maksuda I can see a significant improvement in your performance; well done.
Abdul Rahim Khan
2 years ago
Lifetime risks of kidney donation: a medical decision analysis Please summarise this article in your own words Historically studies have concluded that post kidney donation there is higher risk of diabetes , hypertension, chronic kidney disease, proteinuria as compared to healthy non donors. These risk were noted to be higher in males as compared to females. There was higher risk in Blacks as compared to whites. This study compared the risk of loss of life and ESRD in donors ( Blacks , whites, Males, Females) post donation when compared to matched healthy donors. Target population – Over age 40 , blacks, whites, males and females in US Design– Markov Medical Decision Analysis Results- Risk of ESRD is higher in donors as compared to non donors. Donation can decrease life up to a year- Overall the 1.2-2.3% remaining years were lost. Most of the loss of life was associated with CKD and not ESRD The risk is higher in males, blacks, family relatives , if high BMI and smokers. Most of the events occurred 25 years post donation Conclusion Post donation life can decrease by 1 year Life style modification may improve outcomes including low risk of ESRD and improvement in longevity What is the level of evidence provided by this article? Cohort study Level 11
What is the level of evidence provided by this article?
The article’s name is Lifetime risks of kidney donation: a medical decision analysis. The objective of the study is to try to estimate the potential loss of life and the cumulative lifetime risk of kidney failure from living kidney donation. The risk of kidney failure from initial studies was small and the mortality was about 3.1 per 10000 operations but in the recent investigation, there has been an increase in ESRD from donation and as such an increase in CVD. It was also noted that some donors actually develop DM and this may predispose them to develop HTN. All the above risk factors increase the possibility of kidney failure.
The population that was targeted was 40 years old live kidney donors of different racial backgrounds and also different sexes. It was found that the risk of kidney failure was higher in males and the black race. It was noticed that about 1-5% of the average age of current live kidney donors may develop kidney failure secondary to nephrectomy. Most of the events happen around 25 years or more after the kidney donation. It was found that certain risk factors increase the risk of ESRD and they are:
1) Smoking
2) Obesity
3) DM
One of the interesting points that were noted was that younger live donors have a reduction in their life expectancy due to kidney failure the loss of life was greater in the older population. Also, DM patients had a much greater loss of life due to ESRD. The donors were expected to have a decreased GFR of about 50-85% when compared to non-donors.
So one can conclude from the article that live kidney donors had a reduction or reduced in their life expectancy and the risk was greater in black race and the male sex. It must be taken into consideration that the risk factors must be dealt with aggressively and treated to improve the donor’s survival rate.
Lifetime risks of kidney donation: a medical decision analysis Summaryof the article
CKD is associated with multiple comorbidities and the noticed increased in mortality related to CKD is an important driver of life years lost.
In this study, a USA-based Markov model was used to examine the risk of ESRD in a population of non-donors and donors. There was no patient recruitment or participation in this study but rather the study relied on prior published analyses.
In this study, a sensitivity analysis was assumed that the added time spent in isolated CKD (no proteinuria nor diabetes mellitus) in donors compared with non-donors was not associated with an increase in mortality. In other sensitivity analyses age at donation, smoking status, higher body mass index, new-onset diabetes mellitus and biological relationship to recipient were explored.
The targeted population were 40-year-old patients of both sexes and white/black race from the USA.The time horizon for remaining life years and quality-adjusted life years (QALYS) was lifetime.
Study outcome
1. Differences in survival between the cohorts became apparent after 20 years or more after donation.
2. More than 50% of all ESRD events in donors occurred 25 years or more after donation.
3. The added lifetime cumulative risk of ESRD varied from 1.135% in white female to 4.645% in black male.
4. The per cent loss of life attributed to ESRD in relation to total remaining years of life varied between 0.29% for white female and 0.88% for black male.
5. On a percentage basis, loss of life was greater in older compared with younger donors.life was greater in older compared with younger donors.
6. Life expectancies were markedly reduced and lifetime risks of ESRD increased for cohorts who were smokers or had diabetes mellitus.
7. Surprisingly the absolute loss of life years was slightly less in donors who were obese or smoked compared with donors without these conditions.
8. Donors with diabetes mellitus suffered the greatest loss of life years and increased risk of ESRD.
9. The effect of smoking and diabetes mellitus had large effects on overall survival and in lifetime risks of ESRD in donors and non-donors.
10.Live kidney donation is found to be associated with less peri-operative death rate(0.31death/1000 operations in comparison to live liver donation(1.7/1000), but kidney donation results in more loss of life when adding in the long-term impact.
11.The non-biological relationship to the recipient was associated with lower risk.
Limitations of the study
1. Life expectancy and the cumulative incidences of diabetes mellitus and ESRD are increasing.
2. Using historic mortality and disease incidence rates to make accurate future lifetime projections is a significant limitation.
3. The study was an analysis of US donors, whereas the non-donor control population included US and international populations. The results may not be generalized to live kidney donors from other countries where population ESRD rates are much lower.
4. The model did not include multiple stages of CKD.
5. There was no data on family history of ESRD in the non-biological-related donors.
6. There are many variables and transition rates included in this model and addressing uncertainty in each.
7. Combinations of variables would require a much longer paper.
8. The key uncertainties explored were the cumulative risks of developing ESRD and the increased mortality associated with CKD states..
Strength of the study
1. Asking donors whether they may be willing to give up between 0.5 and 1year of life may be a better way to convey risk than giving them an estimate of their lifetime risk of ESRD.
2. The study identifies the potential importance of following donors and treating risk factors aggressively to prevent ESRD and to improve donor survival.
What is the level of evidence provided by this article?
Thank you, Safi. You are doing much better in this module compared to the last module.
Yashu Saini
2 years ago
INTRODUCTION
The benefits of improved life expectancy and quality of life are established in recipients post kidney transplantation but by achieving this are we risking the life of living kidney donors. This question is of utmost importance and need to have a evidence based and validated answer.
Hence, This study was conducted to estimate the potential loss of life years and quality adjusted life years (QALY) as well as life time risk of ESRD in kidney donor. The participants of this study were 40 year old live kidney donors of both black and white race and both sexes.
METHODS
A USA based theoretical model that uses published population data was unused to examine the risk of ESRD in donors and non-donors.
This theoretical modal had made few assumptions while conducting study:
ESRD rates are increased in donors compared with non-donor
ESRD in both donors and non-donors will be associat- ed with high mortality rates
Donor and non-donors transition through a CKD state for at least 1 year before developing ESRD.
Nephrectomy in donors will quantitatively reduce overall patient kidney function
donors will have a greater risk of falling below a GFR threshold of 60 mL/min/1.73 m2 compared wit non-donors
Cohorts are assumed to be free of hypertension, diabetes mellitus and proteinuria at donation.
CKD states will be associated with higher mortality rates as in the general population, but the magnitude of this effect was examined in additional sensitivity analyses.
Since the study design did not involve any patient recruitment or participation or actual patient inputs, the ethical approval was not needed. So the study population was extracted from previous published studies which met the inclusion criteria.
The target population was cohort of 40 year old patients of both sexes of black and white race from USA for whom recent published estimates of 15 year cumulative risks of ESRD in donors and non-donors were available.
Main outcomes
The health outcome of interest was remaining years of life (undiscounted).
Life years were scaled by measures of quality and discounted at a 3% rate of time preference to calculate QALYs.
Lifetime cumulative incidence of ESRD was also calculated.
Results and Analysis
Non-donors – assumed to have 15-year cumulative ESRD risks of 0.067%, 0.045%, 0.21% and 0.12% for white male, white female, black male and black female, respectively.
Donors – assumed to have 15-year cumulative ESRD risks of 0.34%, 0.15%, 0.96% and 0.59% for white male, white female, black male and black female, respectively
Live kidney donation was associated with an added risk of ESRD especially among those of male sex and black race.
More than 50% of all ESRD events in donors occurred 25 years or more after donation
younger patients lost more potential years of life and had potentially greater risks of ESRD given longer exposure to reduced kidney function
Donors with diabetes mellitus suffered the greatest loss of life years and increased risk of ESRD.
Donation potentially shortens life in average-age donors by about 1%–2%.
Loss of life from CKD was higher compared with life lost from the ESRD health state, there were differences based on race and sex.
Having a non-biological rela- tionship to the recipient was associated with lower risks; however, the majority of donors are related.
The loss of life from live kidney donation is projected to be far less than smoking or mild obesity
Conclusions
Given the need for large numbers of patients and controls and long term follow-up, this risk may never be accurately measured
estimating lifetime ESRD rates in non-donors may not be the best or only metric to inform the risk of donation
Telling donors whether they may be willing to give up between 0.5 and 1year of life may be a better way to convey risk than giving them an estimate of their lifetime risk of ESRD.
following donors and treating risk factors aggressively to prevent ESRD and to improve donor survival is very important.
obesity and smoking are risk factors that might develop after donation, encouraging a healthy lifestyle at donor evaluation and postdonation is also important.
Limitations
Researchers relied upon observed rates of ESRD over 15 years in actual donors and and theoretical matched cohort .
Historic mortality and disease incidence rates were used to make future lifetime predictions.
Analysis was on US donors but international population was included in non-donor controls.
The model didn’t include multiple stages of CKD
The study had some paradoxes
Strengths
The study projects the long-term risk of donating a kidney, including loss of life and the added risk of end-stage renal failure
These findings help quantify and communicate risk to potential donors and convey the importance of lifelong follow-up in actual donors
The study uses evidence of over 15 years of follow- up in actual live kidney donors and healthy controls.
Lifetime risks of kidney donation: a medical decision analysis
Please summarize this article in your own words
This is a retrospective cohort study (level III) in which prediction models are applied on published data to predict the remaining years of life, quality-adjusted life years, and cumulative incidence of developing ESKD in living kidney donors of age 40 years over 15 years of follow-up in comparison to non-donors utilizing Markov model. The primary outcomes were: · Remaining years of life · QOL lost. · Lifetime cumulative ESRD incidence The outcomes measured included: The projected survival was similar between donors and donors up to 20 years after which it was higher in the non-donors (more than 50% of ESRD occurred more than 25 years post-donation). 1. Remaining years of life: Loss of 1.2-2.34% of remaining life year. The risk of life loss was higher in males and African-Americans. 2. The percent loss of QOL was also highest in African American males and lowest in Caucasian females and the presence of CKD IS accounted for most of the reduction in QOL. 3. Lifetime cumulative ESRD incidence: 1-5%. Added risk of ESRD which associated with reduction of remaining years of life around 0.126-0.344 years. Smoking, obesity, diabetes mellitus, and biologically related organ donation were associated with increased Lifetime cumulative ESRD incidence and loss of life. It also noticed that non-donors with smoking and obesity are exposed to the risk of decreased life and increased ESRD more than the risk associated with a donation in the donors. Conclusion Donation reduced life by 1-2% in a 40-year-old donor but this reduction is lower than what is caused by smoking and obesity. In the sub-analysis, the younger population of patients had more life years lost and had a higher risk of developing ESKD. Limitations: The studies included had small numbers and short-term follow-up (around 15y). Donors from US and the control group (non-donor) included international populations.
Lifetime risks of kidney donation: a medical decision analysis
▪︎The objectives of this study were to estimate the potential loss of life as well as the added lifetime risk of ESRD in average-risk kidney donors.
♧Introduction:
▪︎Patients who donate a kidney have an increase in risk of ESRD, cardiovascular mortality, CKD as defined by a low GFR of <60mL/min/1.73m2 or proteinuria, DM and hypertension. ♧Methods Model description ▪︎ A USA-based Markov model was used to examine the risk of ESRD in a population of non-donors and donors.
Participants 40-year-old live kidney donors of both sexes and black/white race. Intervention Live donor nephrectomy. Main outcome and measures Potential remaining life years lost, quality-adjusted life years (QALYs) lost and added lifetime cumulative risk of ESRD from donation.
♧Results ▪︎Overall 0.532–0.884 remaining life years were lost from donating a kidney. This was equivalent to 1.20%–2.34% of remaining life years (or 0.76%–1.51% remaining QALYs).
▪︎ The risk was higher in male and black individuals. The study showed that 1%–5% of average-age current live kidney donors might develop ESRD due to nephrectomy.
▪︎ The added risk of ESRD resulted in a loss of only 0.126–0.344 remaining life years.
▪︎Most of the loss of life was predicted to be associated with CKD not ESRD. ▪︎Most events occurred 25 or more years after donation. Reducing the increased risk of death associated with CKD had a modest overall effect on the per cent loss of remaining life years. ▪︎Smoking and obesity reduced life expectancy and increased overall lifetime risks of ESRD in non-donors. However the percentage loss of remaining life years from donation was not very different in those with or without these risk factors.
♧Strength of the study:
1. It had projected the long-term risk of donating a kidney, including loss of life and the added risk of ESRD. These fndings help quantify and communicate risk to potential donors and convey the importance of lifelong follow-up in actual donors.
2. The study have used evidence of over 15 years of followup in actual live kidney donors and healthy controls.
♧ Limitation:
1. The ability to predict lifetime outcomes from 15- year follow-up in donors of all ages & medical conditions
2. The study was an analysis of US donors, whereas the non-donor control population included US and international populations. The results may not be generalised to live kidney donors from other countries where population ESRD rates are much lower.
3. There are many variables and transition rates included in
this model and addressing uncertainty in each or combinations of variables would require a much longer paper.
4. The key uncertainties explored were the cumulative risks of developing ESRD and the increased mortality associated with CKD states. Lower risks of DM and proteinuria were also explored in ideal donors.
5. The model did not include multiple stages of CKD. Since donors eventually have a greater risk of entering into a more advanced CKD state, this analysis may have underestimated the overall net loss of life years from nephrectomy.
6. The study have used a uniform cohort of 40-year-old individuals in the baseline analysis, whereas the information available is from a cohort of donors with a wide range of ages.
That is an excellent reply Dr Ashmaig,
It is an observational retrospective cohort study that has used historical population based control (with all its limitations). I would call it level 2 rather than level 3.
If it were case-control study then it would be called level 3.
I am well aware that care-control studies have been kept with retrospective cohort by many thinkers.
1a:Systematic review (with homogeneity) of inception cohort studies; or a clinical decision rule validated in different populations.
1b:Individual inception cohort study with > 80% follow-up; or a clinical decision rule validated on a single population
1c:All or none case-series
2a:Systematic review (with homogeneity) of either retrospective cohort studies or untreated control groups in randomized controlled trials.
2b:Retrospective cohort study or follow-up of untreated control patients in a randomized controlled trial; or derivation of a clinical decision rule or validated on split-sample only
2c:”Outcomes” research
3a:Systematic review (with homogeneity) of case-control studies
3b:Individual case-control study
Thank you v.much Prof Ajay for your reply and valuable informations… for sure I will keep it and revise.
Huda Al-Taee
2 years ago
Aim of the study:
To estimate the potential loss of life and the cumulative lifetime risk of ESRD from living kidney donation.
Methods:
Target population: 40-year-old patients of both sexes and white/black race from the USA.
Intervention: Donors who underwent unilateral nephrectomy.
Design: Markov medical decision analysis.
All analyses compared outcomes of the same population of healthy potential donors and modelled the effects if all donated.
Primary outcomes: the net difference in remaining life years, QALYs and development of ESRD.
Results:
Overall, 1.20%–2.34% of remaining life years were lost from donating a kidney.
The risk was higher in male and black individuals.
1%–5% of average-age current live kidney donors might develop ESRD as a result of nephrectomy.
The added risk of ESRD resulted in a loss of only 0.126–0.344 remaining life years.
Most of the loss of life was predicted to be associated with CKD, not ESRD.
Most events occurred 25 or more years after donation.
Reducing the increased risk of death associated with CKD had a modest overall effect on the per cent loss of remaining life years (0.72%–1.9%) and QALYs (0.58%–1.33%). Smoking and obesity reduced life expectancy and increased overall lifetime risks of ESRD in non-donors.
However, the percentage loss of remaining life years from donation was not very different in those with or without these risk factors.
Conclusion:
Live kidney donation may reduce life expectancy by 0.5–1 year in most donors.
The development of ESRD in donors may not be the only measure of risk, as most of the predicted loss of life predates ESRD.
The study identifies the potential importance of following donors and treating risk factors aggressively to prevent ESRD and to improve donor survival.
What is the level of evidence provided by this article?
That is an excellent reply Dr Huda.
It is an observational retrospective cohort study that has used historical population based control (with all its limitations). I would call it level 2 rather than level 3.
If it were case-control study then it would be called level 3.
I am well aware that care-control studies have been kept with retrospective cohort by many thinkers.
1a:Systematic review (with homogeneity) of inception cohort studies; or a clinical decision rule validated in different populations.
1b:Individual inception cohort study with > 80% follow-up; or a clinical decision rule validated on a single population
1c:All or none case-series
2a:Systematic review (with homogeneity) of either retrospective cohort studies or untreated control groups in randomized controlled trials.
2b:Retrospective cohort study or follow-up of untreated control patients in a randomized controlled trial; or derivation of a clinical decision rule or validated on split-sample only
2c:”Outcomes” research
3a:Systematic review (with homogeneity) of case-control studies
3b:Individual case-control study
I. Lifetime risks of kidney donation: a medical decision analysis Please summarise this article in your own words Introduction The risks to the donors are usually small to modest, with a low post-operative mortality (3.1 deaths/10 000 operations). The long-term risks are also small especially in low-risk donors who are well screened. Recent reports show there is some increase in risk of ESRD from donation & possibly an increase in CV mortality. Patients who donate a kidney may be at increased risk of developing CKD (GFR <60) or proteinuria. Some donors will develop DM at a later date despite screening & may be at higher risk of developing HTN. The objective of this study was to estimate the potential loss of life as well as the added lifetime risk of ESRD in average-risk kidney donors. Methods Model description A USA-based Markov model was used to examine the risk of ESRD in a population of non-donors & donors. The key assumptions for the model are: ·ESRD rates are increased in donors versus non-donors. ·ESRD in donors & non-donors will be associated with high mortality rates. ·Donor & non-donors go through a CKD state for at least 1 year before ESRD develops. ·Since ESRD rates are increased in donors versus non-donors, it is assumed there was an increase in the rate of transition to & time spent in CKD states. ·Nephrectomy will reduce overall kidney function. Donors will have a greater risk of falling below a GFR threshold of 60 mL/min compared with non-donors. ·Cohorts assumed to be free of HTN, DM & proteinuria at donation but are at risk of developing these conditions whether they donate or not, & these will impact patient survival & loss of kidney function in both groups. ·CKD states will be associated with higher mortality rates as in the general population.
·Model transition rates from normal to CKD states could be empirically derived to reproduce observed 15-year cumulative incidence rates for ESRD in donors & non-donors & can subsequently project lifetime cumulative risks of ESRD. Patient involvement in study design
No patient recruitment or participation; the study relied on prior published analyses. Target population Case cohorts were 40-year-old (mean age of live donors, median age 38) patients of both sexes & white/black race from the USA. Main outcome measures The remaining years of life. Life years were scaled by measures of quality & discounted at a 3% rate of time preference to calculate QALYs. Lifetime cumulative incidence of ESRD was also calculated. Intervention effects Donors had unilateral nephrectomy & it is assumed that this results in a loss of GFR, & this would increase the probability of transition from a normal GFR (≥60) to CKD. Time horizon Lifetime. For ESRD, the cumulative incidence truncated at age 90. Outcomes Primary outcomes: The net difference in remaining life years, QALYs & development of ESRD. Results Differences in survival between the cohorts became apparent after =/>20 years after donation. The remaining life years lost from donation is from 0.532 years (white female) & 0.884 years (black female donors). The % loss of life was highest in black male donors. The % loss of life varied from 1.20% (white female) to 2.34% (black male). The % loss of total QALYs is from 0.76% (white female) to 1.51% (black male). LKD was associated with an added risk of ESRD (especially male & black race). > 50% of all ESRD events in donors occurred =/> 25 years after donation. The % loss of life attributed to ESRD in relation to total remaining years of life is from 0.29% (white female) & 0.88% (black male). Younger patients lost more years of life & had greater risks of ESRD (longer exposure to reduced kidney function); however, loss of life was greater in older versus younger donors. Reduced life expectancy & increased lifetime risks of ESRD among cohorts who were smokers or had DM. Donors with DM had the greatest loss of life years & increased risk of ESRD. Non-biological relationship to the recipient associated with much lower loss of life years & risk of ESRD versus those who were biologically related. Discussion The short-term studies (<20 years) even with matched normal controls are not likely to detect an adverse effect on survival. A significant % of the loss of life was associated with CKD not ESRD. Death during the CKD state accounts for most of the projected increase in mortality & reduction in QALYs. It is unclear whether there is a significant risk of death from donation; however, studies were small in size, lacked highly screened controls & of relatively short-term (<30 years) follow-up. The % of patients modelled to be alive at 20 years post nephrectomy for an average-age white male donor was 0.2% lower than a non-donor. 78% of the loss of all QALYs from donation was associated with CKD in white female; the loss was 58% in black male. White males have greater added long-term ESRD risks from donation than would be expected (1 for every 28 donors versus 1 in 22 for black males). The loss of life from LKD is projected to be far less than smoking or mild obesity. Live partial liver donation may be less risky over the long term compared with live kidney donation. The life years lost from donation are more than the life years gained from colorectal cancer screening in an average-risk person. Younger donors have greater added risks of ESRD & potential life years lost. The effect of smoking & DM had large effects on overall survival & in lifetime risks of ESRD in donors & non-donors. Counseling & interventions to reduce weight & smoking cessation are more important to both donor & non-donor & less of an argument to deny donation. Donors with DM were at very high added risks of ESRD & death. Limitations Reliance on a theoretical matched cohort to calculate lifetime outcomes. Historic mortality & disease incidence rates used to make accurate future lifetime rates. The results may not be generalized to LKDs from countries other than the US. Multiple stages of CKD were not included. Conclusion Asking donors whether they are ready to give up between 0.5 & 1 year of life may be a better way to show risk than giving them an estimate of their lifetime risk of ESRD. The study identifies the importance of following donors & treating risk factors aggressively to prevent ESRD & to improve donor survival. Because many of the risk factors develop years after donation, short-term follow-up of kidney donors may be inadequate. ======================= What is the level of evidence provided by this article?
LEVEL III, retrospective cohort study However, the reliance of the study on many assumptions makes me think that this is rather Level V,expert opinion
That is an excellent reply Dr Mohamed,
It is an observational retrospective cohort study that has used historical population based control (with all its limitations). I would call it level 2 rather than level 3.
If it were casecontrol study then it would be called level 3. On the basis of discussion and expression of views, why would you call it level 5? The data and its analysis is the key, that is level 2.
I am well aware that care-control studies have been kept with retrospective cohort by many thinkers.
1a:Systematic review (with homogeneity) of inception cohort studies; or a clinical decision rule validated in different populations.
1b:Individual inception cohort study with > 80% follow-up; or a clinical decision rule validated on a single population
1c:All or none case-series
2a:Systematic review (with homogeneity) of either retrospective cohort studies or untreated control groups in randomized controlled trials.
2b:Retrospective cohort study or follow-up of untreated control patients in a randomized controlled trial; or derivation of a clinical decision rule or validated on split-sample only
2c:”Outcomes” research
3a:Systematic review (with homogeneity) of case-control studies
3b:Individual case-control study
5:Expert opinion without explicit critical appraisal, or based on physiology, bench research or “first principles”
Last edited 2 years ago by Ajay Kumar Sharma
Mahmud Islam
2 years ago
First of all, I am not sure about the evidence in this paper. To be honest, I had difficulty in summarizing it as evidence-based. I skimmed and scanned but did not find the number of cases included in the study, but I guessed from table one the number is the sum of (26+88+22+27: total 163? ). The model itself is something we are not familiar with but to summarize:
Life donation was found to have some risk in terms of CKD when defined as eGFR < 60 ml/min./1.73 m2. This was found to be higher post-donation. In terms of lost life years, it was -0.5- 0.884 the least in white females, but in average, the number is not high, and it is not easy to interpret for many reasons, one of them being the influence of multiple factors other than donating itself. the added cumulative risk was reported to be +1.35% in white females, which is nearly 3 times higher in white males and both black males and females). one important point here is the donors are American, but non-donors include non-Americans, which makes the generalizability difficult. The overall survival, as seen in figures 2-4, is not dramatically different between donors versus nondonor groups.
Objective: to estimate the potential loss of life and the lifetime cumulative risk of end-stage renal disease (ESRD) from live kidney donation.
Main outcome and measures: To Know the overall effect of donation on remaining life years and remaining quality-adjusted life years (QALYs) lost and added lifetime cumulative risk of ESRD from donation.
Target population: Participants of 40-year-old live kidney donors of both sexes and black/white race. Intervention Live donor nephrectomy.
Results:
· Overall, 0.532–0.884 remaining life years were lost from donating a kidney. This was equivalent to 1.20%–2.34% of remaining life years (or 0.76%–1.51% remaining QALYs). The risk was higher in male and black individuals.
· The per cent loss of total QALYs varied from 0.76% for white female to 1.51% for black male.
· 1%–5% of average-age current live kidney donors might develop ESRD because of nephrectomy. The added risk of ESRD resulted in a loss of only 0.126–0.344 remaining life years.
· Most events occurred 25 or more years after donation.
· Smoking and obesity reduced life expectancy and increased overall lifetime risks of ESRD in non-donors. However, the percentage loss of remaining life years from donation was not very different in those with or without these risk factors.
· Life expectancies were markedly reduced and lifetime risks of ESRD increased for cohorts who were smokers or had diabetes mellitus. Obese patients were also at increased risk but less so compared with smokers and those with diabetes mellitus.
· In a variety of subgroup analyses younger patients lost more potential years of life and had potentially greater risks of ESRD given longer exposure to reduced kidney function. However, on a percentage basis, loss of life was greater in older compared with younger donors.
· Donors with diabetes mellitus suffered the greatest loss of life years and increased risk of ESRD.
· Non-biological relationship to the recipient was associated with much lower loss of life years and risk of ESRD compared with those who were biologically related.
· Donors were projected to spend 50%–85%more time with an isolated low glomerular filtration rate CKD (CKD not associated with diabetes mellitus or proteinuria) compared with non-donors.
Conclusion:
· Live kidney donation may reduce life expectancy by 0.5–1 year in most donors.
· Live kidney donation was associated with an added risk of ESRD especially among those of male sex and black race.
· Risk factors should be treated aggressively to prevent ESRD and to improve donor survival.
That is an excellent reply Dr Alalawi.
Please use type in bold or underlining for headings and sub-headings. That makes it easier to read.
It is an observational retrospective cohort study that has used historical population based control (with all its limitations). I would call it level 2 rather than level 3.
If it were case control study then it would be called level 3.
I am well aware that care-control studies have been kept with retrospective cohort by many thinkers.
1a:Systematic review (with homogeneity) of inception cohort studies; or a clinical decision rule validated in different populations.
1b:Individual inception cohort study with > 80% follow-up; or a clinical decision rule validated on a single population
1c:All or none case-series
2a:Systematic review (with homogeneity) of either retrospective cohort studies or untreated control groups in randomized controlled trials.
2b:Retrospective cohort study or follow-up of untreated control patients in a randomized controlled trial; or derivation of a clinical decision rule or validated on split-sample only
2c:”Outcomes” research
3a:Systematic review (with homogeneity) of case-control studies
3b:Individual case-control study
5:Expert opinion without explicit critical appraisal, or based on physiology, bench research or “first principles”
Last edited 2 years ago by Ajay Kumar Sharma
MOHAMMED GAFAR medi913911@gmail.com
2 years ago
Patients who donate a kidney may be at greater risk of developing chronic kidney disease (CKD) as defined by a low glomerular filtration rate (GFR) of <60mL/ min/1.73 m2 or proteinuria.
donation potentially shortens life in average age donors by about 1%–2% These conditions could accelerate the loss of kidney function and increase the risk of ESRD .
younger patients lost more potential years of life and had potentially greater risks of ESRD given longer exposure to reduced kidney function .
Life expectancies were markedly reduced and lifetime risks of ESRD increased for cohorts who were smokers or had diabetes mellitus .
Obese patients were also at increased risk but less so compared with smokers and those with diabetes mellitus.
Non-biological relationship to the recipient was associated with much lower loss of life years and risk of ESRD compared with those who were biologically related.
What is the level of evidence provided by this article?
My goodness that is a superb reply, dear Dr Sobair. I can not improve upon this.
Mohammed Abdallah
2 years ago
Please summarise this article in your own words
Aim of the study was to estimate the potential loss of life as well as the added lifetime risk of ESRD in average-risk kidney donors
The study used Markov model design examines the risk of ESRD in donors and non-donors. Assumptions for the model were:
* ESRD rates are increased in donors compared with non-donors
* ESRD in both donors and non-donors will be associated with high mortality rates
* Donor and non-donors transition through a CKD state for at least 1 year before developing ESRD
* The rate of transition to and time spent in CKD as ESRD rates are increased in donors compared with non-donors
* Nephrectomy reduce overall patient kidney function, so donors will have a greater risk of falling < GFR compared with non-donors
Donors are free of HTN, DM and proteinuria. However they are at risk of developing these conditions whether they donate or not, and these will impact patient survival and loss of kidney function in both donors and non-donors
There was no patient participation in this study (relied on prior published analyses). Case cohorts were 40-year-old patients of both sexes and white/black race from the USA. The main outcome was remaining years of life. The study underwent unilateral nephrectomy and the time for remaining life years and quality-adjusted life years was lifetime (for ESRD was at age 90)
All analyses compared outcomes of the same population of healthy potential donors and modelled the effects if all donated. Primary outcomes were remaining life years, quality-adjusted life years and ESRD
Differences in survival between the cohorts became apparent after 20 years or more after donation. The remaining life years lost from donation ranged between 0.532 years for white female and 0.884 years for black female donors. The loss of life was highest in black male donors. The loss of life varied from 1.20% for white female to 2.34% for black male
In this study donation shortens life in average-age donors by about 1%–2%. Although ESRD is associated with very high mortality rates, a significant per cent of the loss of life was associated with CKD not ESRD. Other risk factors may be associated with higher rates of death and ESRD (smoking, obesity and biological relationship to the recipient)
Limitation of the study is the ability to predict lifetime outcomes from 15- year follow-up in donors of all ages and medical conditions
What is the level of evidence provided by this article?
Summary: This cohort study of 40 years donors ( median age 38 ) with life time risk of ESRD/CKD, quality adjusted life years(QALY’s), and remaining years in life, compared donors and non donor whom underwent a thorough evaluation for donation. for 15 years follow up and to estimate the potential loss of life as well as the added lifetime risk of ESRD in average-risk kidney donor Live kidney donation was associated with an added risk of ESRD specially among male and black population. The added lifetime cumulative risk of ESRD varied from 1.135% in white female to 4.645% in black male. In a variety of subgroup analyses younger donors lost more potential years of life and had potentially greater risks of ESRD given longer exposure to reduced kidney function. However, on a percentage basis, loss of life was greater in older compared with younger donors.
Life expectancies were notably reduced and lifetime risks of ESRD increased for cohorts who were smokers or had DM. Obese had also increased risk but less so compared with smokers and those with DM. Surprisingly the absolute loss of life years was slightly less in donors who were obese or smoked compared with donors without these conditions. Donors with DM suffered the greatest loss of life years and increased risk of ESRD. Level of evidence: level III
The objectives; to estimate the potential loss of life as well as the added lifetime risk of ESRD in average-risk kidney donors.
Design; A USA-based Markov model was used to examine the risk of ESRD in a population of non-donors and donors.
The study relied on prior published analyses.
Target population; 40-year-old patients of both sexes and white/black race from the USA.
Intervention Live donor nephrectomy.
Main outcome and measures Potential remaining life years lost, quality-adjusted life years (QALYs) lost and added lifetime cumulative risk of ESRD from donation.
Time horizon The time horizon for remaining life years and QALYS waslifetime. However, for ESRD, the cumulative incidencewas truncated at age 90 in keeping with other studies.
Analysis; All analyses compared outcomes of the same population of healthy potential donors and modelled the effects if all donated.
Cohort assumed that donors were initially disease-free but could subsequently develop these conditions at rates seen in the general population.
Results:
Differences in survivalbetween the cohorts became apparent after 20 years ormore after donation.
The remaining life years lost from donation ranged between 0.532–0.884
This was equivalent to 1.20%–2.34% of remaining life years or (0.76%–1.51% remaining QALYs).
The risk was higher in male and black individuals.
The study showed that 1%–5% of average-age current live kidney donors might develop ESRD as a result of nephrectomy.
The added risk of ESRD resulted in a loss of only 0.126–0.344 remaining life years.
Most of the loss of life was predicted to be associated with chronic kidney disease (CKD) not ESRD.
Most events occurred 25 or more years after donation.
Death during the CKD health state accounted for most of the projected increase in mortality and reduction in QALYs. Intuitively this makes some sense given that the transition from CKD to ESRD can be over many years and that progressive kidney disease is associated with graded increases in mortality
Despite differences in the absolute rates of ESRD in both donors and non-donors, the absolute and percent loss of life years and QALYs from donation were only modestly lower compared with the base case analysis.
Smoking and obesity reduced life expectancy and increased overall lifetime risks of ESRD in non-donors.
However the percentage loss of remaining life years from donation was not very different in those with or without these risk factors.
Conclusion Live kidney donation may reduce life expectancy by 0.5–1 year in most donors. The development of ESRD in donors may not be the only measure of risk as most of the predicted loss of life predates ESRD. The study identifies the potential importance of following donors and treating risk factors aggressively to prevent ESRD and to improve donor survival.
Limitations of the study
– Using historic mortality and disease incidence rates to make accurate future lifetime projections is a significant limitation.
-The study was an analysis of US donors, whereas the non-donor control population included US and international populations. The results may not be generalized to live kidney donors from other countries where population ESRD rates are much lower.
-The model did not include multiple stages of CKD.
-There was no data on family history of ESRD in the non-biological-related donors.
-The key uncertainties explored were the cumulative risks of developing ESRD and the increased mortality associated with CKD states..
Strength of the study
Asking donors whether they may be willing to give up between 0.5 and 1year of life may be a better way to convey risk than giving them an estimate of their lifetime risk of ESRD.
What is the level of evidence provided by this article?
Level 2, observational longitudinal cohort study with population data as controls.
Early studies have reported no or minimal risks associated with kidney donation in low risk, well-assessed kidney donors.
However, recent studies showed that there is some increase in risk of end-stage renal disease (ESRD) from donation and possibly an increase in cardiovascular mortality.
Recent studies reported following results:
– Greater risk of developing chronic kidney disease (CKD) as defined by a low glomerular filtration rate (GFR).
– Some donors will develop diabetes mellitus at a later date despite being screened and may be at higher risk of developing hypertension.
– A recent report projected the 15-year and lifetime risk of ESRD in potential non-donors to assist in counselling patients who are considering donation. Those with minor medical abnormalities, men and individuals of black race had greater 15-year and lifetime risks of ESRD.
The provided study estimated the potential loss of life and the lifetime cumulative risk of ESRD from live kidney donation.
Target population
The base case cohorts were 40-year-old patients of both sexes and white/black race from the USA.
Main outcome measures
The health outcome of interest was remaining years of life.
Results
– Differences in survival between the cohorts became apparent after 20 years or more after donation.
– The remaining life years lost from donation ranged between 0.532 years for white female and 0.884 years for black female donors. The per cent loss of life was highest in black male donors.
– The per cent loss of life varied from 1.20% for white female to 2.34% for black male.
In conclusion, kidney transplantation is the best treatment for potential recipients, however it may carry risk of ESRD, cardiovascular complications and reduction in remaining years of life. In the post donation period, donors should be followed up tightly for the remaining life time. Risk factors like obesity, smoking, hypertension and diabetes mellitus should be controlled to avoid progression of kidney disease
#Please summarise this article in your own words
# Objective:
To evaluate the potential loss of life and the lifetime cumulative risk of (ESRD) from live kidney donation.
# Introduction:
*About 30 000 live donor kidney transplant surgeries are done throughout the world per year, which had advantage to recipients in improving life expectancy and quality of life when compared with dialysis or deceased donor transplantation.
* The risks to the donors are generally small to modest; with reduce the mortality rate after operation.
* The long-term risks are also presumed to be small especially in low-risk donors who are adequately screened, however recent studies show that there is some increase in risk of (ESRD) from donation and increase in cardiovascular mortality.
#Methods
#Model description
*A USA-based Markov model was used to examine the risk of ESRD in a population of non-donors and donors.
#The following are the key assumptions for the model:
*The incidence of ESRD rates are higher in donors compared with non-donors.
*In both donors and non-donors ESRD will be associated with high mortality rates.
* Donor and non-donors transition through a CKD state for at least 1 year before developing ESRD.
* As the ESRD rates are high in donors compared with non-donors, so there have been
an increase in the rate of transition to and time spent in CKD states.
* Nephrectomy in donors will quantitatively reduce overall patient kidney function.
(donors will have a greater risk of falling below a GFR threshold of 60 mL/min/1.73 m2 compared with non-donors).
* Cohorts are assumed to be free of HTN, DM and proteinuria at donation, but they are risky to developing these conditions whether they donate or not, and these will impact patient survival and loss of kidney function in both donors and non-donors.
*CKD states will be associated with higher mortality rates as in the general population.
* Model transition rates from normal to CKD states could be empirically derived to reproduce observed 15-year cumulative incidence rates for ESRD in donors and non-donors and can be used to subsequently project lifetime cumulative risks of ESRD.
# Results:
*Overall 0.532–0.884 remaining life years were lost from donating a kidney. This was equivalent to 1.20%–2.34% of remaining life years (or 0.76%–1.51% remaining QALYs).
*The risk was higher in male and black individuals.
The study showed that 1%–5% of average-age current live kidney donors might develop ESRD as a result of nephrectomy. The added risk of ESRD resulted in a loss of only 0.126–0.344 remaining life years. Most of the loss of life was predicted to be associated with chronic kidney disease (CKD) not ESRD.
*Most events occurred 25 or more years after donation. Reducing the increased risk of death associated with CKD had a modest overall effect on the per cent loss of remaining life years (0.72%–1.9%) and QALYs (0.58%–1.33%).
*Smoking and obesity reduced life expectancy and increased overall lifetime risks of ESRD in non-donors. However the percentage loss of remaining life years from donation was not very different in those with or without these risk factors.
# The strength and limitation:
*The study projects the long-term risk of donating a kidney, including loss of life and the added risk of end-stage renal failure.
* These findings help quantify and communicate risk to potential donors and convey the importance of lifelong follow-up in actual donors.
* The study uses evidence of over 15 years of follow up in actual live kidney donors and healthy controls.
*The ability to predict lifetime outcomes from 15- year follow-up in donors of all ages and medical conditions is a limitation.
# Conclusion
Live kidney donation may reduce life expectancy by 0.5–1 year in most donors. The
development of ESRD in donors may not be the only measure of risk as most of the predicted loss of life predates ESRD. The study identifies the potential importance of following donors and treating risk factors aggressively to prevent ESRD and to improve donor survival.
# What is the level of evidence provided by this article?
It is cohort study, prospective study level 2.
Please summarise this article in your own words
cohort study for 40 years donors, life time risk of ESRD/CKD, quality adjusted life years(QALY’s), and remaining years in life, compared donors and non donor whom underwent a thorough evaluation for donation. for 15 years follow up.
Intervention: Donor nephrectomy.
Results:
The remaining years in life lost was higher among black male 2.35% in comparison to 1.2% in white females.(loss of life 0.88% black males to 0.29% white females
The risk of ESRD was higher in black males 4.645% compared to 1.135% in white females.
The (QALY’s) loss was more in back male also 1.51% in comparison to 0.76% in white females.
Being black male make the donor more prone to experience ESRD and decreased over all life time as well as QALY’s
The donors spend 50-85%more time with CKD(GFR <60 ml/min/1.73m2), not related to DM ,HTH, or proteinuria .
The absolute loss of life years was slightly less in donors who were obese or smoked.
Donors with diabetes mellitus suffered the greatest loss of life years and increased risk of ESRD.
Conclusion:
Asking donors whether they may be willing to give up between 0.5 and 1 year of life may be a better way to convey risk than giving them an estimate risk of ESRD.
The young white female donors have more favorable out comes. Non-biological relationship to the recipient was associated with lower risk.
What is the level of evidence provided by this article? Level of evidence II- Cohort study.
Summary:
· Living kidney donation is associated with some long-term effects despite being well screened at time of donation and were free from diseases, the possible complications include:
o Risk of CKD progression.
o Small risk of higher mortality (detected years after donation) with 1-2 % shortage of expected life span (lower by 0.5-1 year).
o Risk of hypertension and proteinuria.
· The current study aims to evaluate the additional risk of mortality and CKD progression.
· As regard the risk factors of CKD progression, they include smoking, obesity and relation to the recipient.
· Mortality risk still has unclear etiology (not completely related to the risk of CKD). CKD defined as GFR less than 60 ml/min/1.72 m2.
· The risk of ESKD was associated with many risk factors as development of DM, HTN or proteinuria, in addition to male sex, black races and obesity. Level of evidence : cohort study (level II).
Ø The study estimated the potential loss of life and the lifetime cumulative risk of end-stage renal disease (ESRD) from live kidney donation. Participants 40-year-old live kidney donors of both sexes and black/white race, underwent live donor nephrectomy.
Ø Main outcome and measures Potential remaining life years lost, quality-adjusted life years (QALYs) lost and added lifetime cumulative risk of ESRD from donation.
Ø Overall 0.532–0.884 remaining life years were lost from donating a kidney. This was equivalent to 1.20%–2.34% of remaining life years (The risk was higher in male and black individuals. The study showed that 1%–5% of average-age current live kidney donors might develop ESRD as a result of nephrectomy. Most of the loss of life was predicted to be associated with chronic kidney disease (CKD) not ESRD. Most events occurred 25 or more years after donation.
Ø Live kidney donation may reduce life expectancy by 0.5–1 year in most donors. The development of ESRD in donors may not be the only measure of risk as most of the predicted loss of life predates ESRD. The study identifies the potential importance of following donors and treating risk factors aggressively to prevent ESRD and to improve donor survival
Level 2
This is a case cohorts study with level 2 evidence to study the life time risks of kidney donation. Overall 0.532–0.884 remaining life years were lost from donating a kidney. This was equivalent to 1.20%–2.34% of remaining life years (or 0.76%–1.51% remaining QALYs). The risk was higher in male and black individuals. The study showed that 1%–5% of average-age current live kidney donors might develop ESRD as a result of nephrectomy. The added risk of ESRD resulted in a loss of only 0.126–0.344 remaining life years. Most of the loss of life was predicted to be associated with chronic kidney disease (CKD) not ESRD. Most events occurred 25 or more years after donation. Reducing the increased risk of death associated with CKD had a modest overall effect on the per cent loss of remaining life years (0.72%–1.9%) and QALYs (0.58%–1.33%). Smoking and obesity reduced life expectancy and increased overall lifetime risks of ESRD in non-donors. However the percentage loss of remaining life years from donation was not very different in those with or without these risk factors.
The limitation of this study include rely on the observed rates of ESRD over 15 years in actual donors and a theoretical matched cohort to calculate lifetime outcomes. Using historic mortality and disease incidence rates to make accurate future lifetime projections is a significant limitation. Limited to US population and did not include multiple stages of CKD, thus , lack of generalization.
This study deals with the mortality risk and development of ESRD over 15 years follow up. Markov model used in the study. The study also identifies the potential importance of following up of donors and treating risk factors aggressively to prevent ESRD and to improve donor survival. Inclusion criteria included 40 year population irrespective of gender and race .The primary outcome was Loss of potential remaining life years, quality-adjusted life years (QALYs), and an increase in the lifetime cumulative risk of end-stage renal disease (ESRD)after donation.
Results: The risk factors which are associated with ESRD and mortality are smoking, obesity,and diabetes mellitus. The incidence of end-stage renal disease (ESRD) after nephrectomy ranges from 1% to 5% among current living kidney donors of average age. There was 1.2-2.34 % loss of remaining life years (0.76-1.51 % QALYs).Male and black people have increased risk. Non-biological relationship to the recipient was associated with much lower loss of life years and risk of ESRD compared with those who were biologically related. Loss of life was greater in older compared with younger donors. ESKD is associated with very high mortality rate , a significant percent of loss of life was associated with CKD not ESKD. There was not a significant difference in the proportion of remaining life years lost due to donation between individuals who had these risk factors and those who did not.The limitation of the study is that donors were of variable ages and medical conditions
In short, donors should be closely monitored for their remaining life and all risk factors like smoking, obesity ,hypertension and diabetes mellitus should be well controlled to halt the progression of CKD.
What is the level of evidence provided by this article?
Retrospective cohort study-level of evidence III
The study aimed to estimate the risk of losing life or to get ESRD among kidney donors, the mean age was 40 from both sex
the result was no difference in the risk of getting kidney disease in compression with general population and the risk of losing their life by the rate of one year per life
so they concluded that kidney donation not a risk factor in decrease life expectancy but show the importance of following the donor to prevent the complications .
Level 2 evidence
Lifetime risks of kidney donation: a medical decision analysis
Risking the life of living kidney donors for the benefits of improved life expectancy and quality of life of recipients post kidney. This study was conducted to estimate the potential loss of life years and quality adjusted life years (QALY) and life time risk of ESRD in kidney donor.
Methodology
Main outcomes
Outcome of interest was remaining years of life .
Results and Analysis
Non-donors are assumed to have 15-year cumulative ESRD risks of
Donors are assumed to have 15-year cumulative ESRD risks of
Conclusion
What is the level of evidence provided by this article?
Level 2
One of the most common question we asked by the donor is the effect of donation in Life time and the risk for developing ESRD
The aim of this study is to estimate the potential loss of life as well as the added lifetime risk of ESRD in average-risk kidney donors
Target population
40-year-old patients of both sexes and white/black race from the USA. This is the mean age of live donors (median age 38) and for whom there are recent published estimates of 15-year cumulative risks of ESRD in non-donors and donors
Results and discussion
this study show that donation potentially shortens life in average-age donors by about 1%–2%. This analysis shows that short-term studies (<20 years) even with appropriate normal controls are not likely to detect an adverse effect on survival.
The study also explored risk factors that can be associated with higher rates of death and ESRD such as smoking, obesity and biological relationship to the recipient. The mechanism by which low glomerular filtration rate CKD is associated with an increase in cardiovascular and all-cause mortality rate is not completely known. Based on current literature it is unclear whether there is a significant risk of death from donation, but studies have had relatively small numbers, only 0.2% lower than a non-donor
This model incorporated the probability that some donors will develop diabetes mellitus, hypertension and proteinuria at a later date, and these would impact on health (overall survival and progression to ESRD) as they do in the general population. The model could have been simplified if these risk factors for CKD and ESRD were not included in the model, but this would not reflect reality.
The baseline analysis also showed that white males suffer greater added long-term ESRD risks from donation than would be anticipated. For white male the added risk of an ESRD event was 1 for every 28 donors. For black male the risk was 1 in 22. One would have expected the added risk of ESRD in white male to be less than half the added risk in black male from what is known in the general population
The analysis suggests that counselling and interventions to reduce weight and smoking cessation are more important to both donor and non-donor and less of an argument to deny donation. Having a non-biological relationship to the recipient was associated with lower risks; however, the majority of donors are related.5 Donors with diabetes mellitus were at very high added risks of ESRD and death
The model did not include multiple stages of CKD. A more complex model could have been generated to differential stages 3a, 3b, 4 and 5 multiplied by three levels of proteinuria. However this would complicate the model and we do not have enough patient-level data to examine this in detail.
As noted the absolute loss of life was higher in younger donors but a greater percentage of loss of life in older donors. These result from a fixed relative risk of death associated with CKD multiplied by low baseline death rates in the young compared with higher death rates in older subjects along with differences in exposure
There is no data on family history of ESRD in the non-biological-related donors. There may be some non-biological-related donors with a family history of kidney disease, which would put them at higher risk. In addition we assumed that the relative risks between white and black of both sexes with a biological relationship were the same.
Conclusion
Donation reduced life by 1-2% in a 40-year-old donor but this reduction is lower than what is caused by smoking and obesity. In the sub-analysis, the younger population of patients had more life years lost and had a higher risk of developing ESKD.
Limitations:
The studies included had small numbers and short-term follow-up (around 15y).
Donors from US and the control group (non-donor) included international populations.
What is the level of evidence provided by this article?
Level 2
This study assessed the possible loss of life and the lifetime ESRD cumulative risk from live kidney donation through USA-based Markov model. It included 40-year-old live kidney donors of both sexes and black/white race. The study showed that 1%–5% of average-age current live kidney donors might develop ESRD as a result of nephrectomy. Overall 0.532–0.884 remaining life years were lost from donating a kidney which was equivalent to 1.20%–2.34% of remaining life years. The per cent loss of life attributed to ESRD in relation to total remaining years of life varied between 0.29% for white female and 0.88% for black male. Live kidney donation was associated with an added risk of ESRD especially among those of male sex and black race. Most of the loss of life was predicted to be associated with chronic kidney disease not ESRD. Despite differences in the absolute rates of ESRD in both donors and non-donors, the absolute and per cent loss of life years and QALYs from donation were only modestly lower compared with the base case analysis. Donors were projected to spend 50%–85% more time with an isolated low glomerular filtration rate CKD (CKD not associated with diabetes mellitus or proteinuria) compared with non-donors. More than 50% of all ESRD events in donors occurred 25 years or more after donation. Smoking and obesity reduced life expectancy and increased overall lifetime risks of ESRD in non-donors. However the percentage loss of remaining life years from donation was not very different in those with or without these risk factors.
level of evidence is II
Lifetime risks of kidney donation: a medical decision analysis
A meticulous selection of donors decreases the long-term donor risk.
Aim of the study: it is to determine the potential loss of life in years and the risk of ESRD after live kidney donation.
Method:
The study group were 40 years old patients of both gender and white and black race from the USA with median age 38 yrs, and for whom there are recently published estimates of 15 yrs cumulative risk of ESRD in non-donor and donors.
Results:
The percent of life loss in black males was more. Percent of life loss varied between white female (1.20%) and black male (2.34%).
Risk of ESRD was higher in black males.
Accumulative risk of ESRD was higher in black males. Diabetic donors at higher risk of ESRD.
Because of longer exposure to reduced kidney function in younger age donors, they are at higher risk of ESRD. As well, they have high potential years of life loss.
Conclusion:
Kidney donation may reduce life expectancy by about 0.5 – 1 year. ESRD is one of the risk of kidney donation. Follow up of the donors and modification of the risk factors aggressively is of paramount important to prevent ESRD
level II
A retrospective cohort study – level IIb.
A model called Markov medical decision analysis was implemented using American position at age 40 including gender or ethnicity. The aim of the study is to define whether there is a difference in the prognosis of living donors with nephrectomy based on sex or ethnicity. The main objectives were to estimate years of potential life lost, adjusted loss of lost years, and cumulative risk of ESRD.
The analysis was done in comparison with a population with the same characteristics as the donor, with the healthy behavior of a potential donor.
The results showed that the difference in survival only occurred after 20 years following donation. Men of black ethnicity had the worst rates of survival, considering QUALYs. The same applies with ESRD, where most cases occurred within 25 years or more of donation.
Even in different sexes, black women (1.74%) are at higher risk compared with white men (1.39%) when compared to black men (1.9%). Young people were at higher risk of donation. Diabetes & smoking are other risk factors, DM being the worst. Obesity may have some related impact, but it is inferior to DM &smoking.
This study showed that the loss of life ranges from 1 to 2%, being more related to CKD but not end-stage renal disease. These risks were different depending on ethnicity ;whites 1 in 28 / blacks 1 in 22. This study recommended smoking cessation with weight loss in those with a BMI greater than 30.
Please summarize this article in your own words
The aim of this study is to estimate the potential loss of life years, quality adjusted life years (QALY) and life time risk of ESRD in living kidney donors.
Study group: Live kidney donors aged 40, black and white race of both sexes in the USA published studies that showed 15 years cumulative risks of ESRD in donors and non-donors.
Study population was derived from previously published studies.
Methods: USA theoretical model for risk of ESRD in donors and non-donors include the following assumptions:
1- Donors have higher ESRD rate than non-donors.
2- ESRD is associated with higher mortality in both groups.
3- Nephrectomy will reduce overall patient kidney function.
4- Donors will have a higher risk of dropping GFR below 60 ml/min/m2.
5- Donors are assumed to be free of HTN, DM and proteinuria at the time of donation.
6- CKD will be associated with higher mortality rate in the general population.
Ethical approval: was not required in this study because there was no patient recruitment or patient input.
Outcomes:
1- Remaining years of life.
2- Life years were scaled by measures of quality and discounted at a 3% rate of time preference to calculate QALYs.
3- Calculated lifetime cumulative incidence of ESRD.
Results:
Donor/non-donors 15 years cumulative ESRD risks for:
White Male: 0.34%/0.067%, White Female: 0.15%/0.045%.
Black Male: 0.96% /0.21%, Black Female: 0.59% /0.12%.
50% of all ESRD events in donors happened 25 years or more post donation.
Younger donors lost more years of life especially donors with DM.
Donation shortens life by 1-2% especially with smokers and those with high BMI.
Strengths:
1- This study predicts the long-term risks of kidney donation in terms of loss of life, and risk of ESRD.
2- Lifelong follow up in donors can be quantified and the risks can be informed to the donors.
3- Evidence from 15 years follow up in donors compared to healthy population.
Limitations:
1- Using data regarding previous mortality and disease incidence to predict future lifetime.
2- Data from USA donors not international population.
3- They didn’t include different stages of CKD.
4- The study used observed rates of ESRD over 15 years in actual donors compared with theoretical matched cohort.
5- Paradoxes.
What is the level of evidence provided by this article?
Level III, retrospective study.
Introduction:
Patients who donate a kidney may be at greater risk (previously thought to be minimal) of developing CKD and decreased eGFR. However, recent reports show that donation may be associated with increase in risk of ESRD and cardiovascular mortality.
Aim of the study:
To estimate the potential loss of life and the cumulative lifetime risk of ESRD from living kidney donation.
Methods:
Participants of 40-year-old live kidney donors of both sexes and black/white race.
Intervention: Live donor nephrectomy.
Design: A USA-based Markov model was used to examine the risk of ESRD in a population of
non-donors and donors.
All analyses compared outcomes of the same population of healthy potential donors and modeled the effects if all donated.
Primary outcomes: the net difference in remaining life years, QALYs and development of ESRD.
Results:
Living kidney donation was associated with an added risk of ESRD especially among those of male sex and black race. More than 50% of all ESRD events in donors occurred ≥ 25 years after donation. The younger age, smoking and diabetic donors suffered the greatest loss of life years and have increased risk of ESRD (Most of the loss of life was predicted to be associated with CKD, not ESRD).
Donation shortens life in average-age donors by about 1%–2%. The loss of life from live kidney donation is projected to be far less than smoking or mild obesity
Limitations:
The studies included had small numbers and short-term follow-up (around 15y).
Analysis was on US donors but international population was included in non-donor controls.
The model didn’t include multiple stages of CKD.
Conclusion:
Live kidney donation may reduce life expectancy by 0.5–1 year in most donors.
Live kidney donation was associated with an added risk of ESRD especially among those of male sex and black race.
Risk factors should be treated aggressively to prevent ESRD and to improve donor survival.
What is the level of evidence provided by this article?
Level 2 (retrospective cohort study).
Introduction
In the past, renal donation was considered to be clear from any donor risk regarding ESRD and renal impairment. Previous studies concluded that the risk of renal impairment was similar to general population until repeated studies with different
parameters involved revealed different results.
Recent studies evaluated the probable risk of ESRD in 15 year interval in potential non-donors to aid counselling patients who think of donation. Individuals with minimal medical abnormalities particularly black race males are of higher 15-year and lifetime risk of ESRD.
The aim of this study is to demonstrate the expected potential loss of life in addition to the lifetime risk of ESRD in average-risk renal donors.
Methods
Cohorts were 40-year-old patients of both sexes and white/black race from the USA. Mean age of live donors’ is average 38 years. Recent estimates of 15-year cumulative risks of ESRD in non-donors and donors are available.
The main outcome of the study is to identify the expected remaining years of life as quality of life is decreased by development of ESRD and other medical comorbidities. Life years were scaled by measures of quality as well as discounted at a 3% rate of time preference to calculate QALYs. Lifetime cumulative incidence of ESRD was also included.
Non-donors were assumed to have 15-year cumulative ESRD risks of 0.067%, 0.045%, 0.21% and 0.12% for white male, white female, black male and black female, respectively. ‘Ideal’ non-donors were assigned lower incidence rates of diabetes mellitus, proteinuria and rates of transition to CKD to match projected lifetime ESRD risks rather than calibrating to 15-year ESRD risks.
Donors were assumed to have 15-year cumulative ESRD risks of 0.34%, 0.15%, 0.96% and 0.59% for white male, white female, black male and black female, respectively.
The elapsed time in case of isolated CKD (no proteinuria nor diabetes mellitus) in donors versus non-donors was not associated with further increase in mortality.
Age of donation, smoking habit, higher BMI, new-onset DM and biological relation to recipients were important points.
Results
Differences in survival among the cohorts became significant 20 years or more following donation.
The expected remaining life years lost from donation average 0.532 years for white female versus 0.884 years for black female donors.
The highest percent loss of life was found in black male donors. The percent loss of life ranged from 1.20% for white female to 2.34% for black male. The per cent loss of total QALYs estimated by 0.76% for white female while 1.51% for black male.
There was added risk of ESRD in living renal donors particularly in males and black race. The expected lifetime cumulative risk of ESRD average 1.135% in white female while 4.645% in black male.
More than 50% of all ESRD cases in donors occurred 25 years or more post renal donation which was significantly earlier in black male than white male. The loss of life percentage due to ESRD in relation to total remaining years of life estimated by 0.29% for white female and 0.88% for black male.
Donors were proposed to have 50%–85% more time isolated low glomerular filtration rate CKD. The expected loss of remaining life years was 0.551, 0.316, 0.682 and0.721 for white male, white female, black male and black female, successively.
Concluding that loss of remaining life years percentage is 1.39%, 0.72%, 1.9% and 1.74% for white male, white female, black male and black female, orderly.
Younger patients tend to lose more potential years of life with potentially more risks of ESRD owing to the longer exposure to reduced renal function. Contrastly, loss of life was significant in older donors when compared to younger donors. Also, life expectancy was reduced in smokers, DM donors as well as obese donors with lesser extent.
Non-biologically related donors were found to have much lower loss of life years as well as risk of ESRD in comparison to biologically related donors.
Discussion
This study elaborates that post renal donation potentially shortens life in average-age donors by 1%–2%. Also highlights that short-term studies less than 20 years even with appropriate normal controls can’t be satisfactory in detecting adverse effects regarding survival. ESRD is associated with very high mortality rates according to this study with significant loss of life percentage was not only associated with ESRD but with CKD as well. Smoking, obesity and biological relationship to the recipient were also addressed as risk factors for development of ESRD and mortality as stated by this study.
Previous studies have rather short-term follow-up interval. So, clear discrepancies were found later when the cumulative effects of CKD were more obvious. Even more, differences are evident in race and sex. Results showed that 78% of the loss of all QALYs post donation was obtained with CKD in white female versus 58% in black male. Guided by risk factors detected as hypertension, diabetes mellitus and other comorbidities, appropriate intervention can further prevent ESRD and improve donor survival.
Longer term studies lately have revealed that some donors might develop diabetes mellitus and hypertension, despite being absent at the time of donation, which can be subsequently responsible for ESRD development. The lifetime added risk of ESRD was found to be lower, that is why the overall predicted absolute loss of life associated was not that different.
The risk of development of ESRD in white male seems to be accelerated after 25–30 years of follow-up. This can be explained by the longer life expectancies.
The expected loss of life from post living renal donation was found to be far less than smoking or mild obesity. Counselling and interventions to reduce weight and smoking cessation are more important for both donor and non-donor. Non-biological relations were associated with lower risks.
One of the limitations of the study was involving analysis of US donors, whereas the non-donor control population involved all US and international populations. The model also did not include multiple stages of CKD owing to lack of patient-level data. The cohort used 40-year-old individuals as baseline analysis, but the information available was from cohort of wide range donors.
Some paradoxes in the analysis were astonishing, as the increased relative mortality risks associated with CKD, however the overall estimates of life loss associated with donation are between 0.5 and 1 year. Also the absolute loss of life was higher in younger donors but a greater percentage of loss of life in older donors. Besides data concerning family history of ESRD in the non-biological-related donors were unavailable. Assumption that the relative risks between white and black of both sexes with a biological relationship were the same was not totally correct.
Thus, follow up the donors and treating risk factors aggressively to prevent ESRD and to improve donor survival is recommended.
Level of evidence is II.
1. Please summarise this article in your own words
The study was meant to estimate the potential loss of life and added life time risk of ESRD in average risk kidney donors using a USA -based Markov model. The mean age of the participant was 40.
The results showed that 1-5% of average- age current live kidney donors might develop ESRD as a result of nephrectomy, the added risk of ESRD resulted in a loss of 0.126-0.344 remaining life years, most of the loss was predicted due to CKD not ESRD. Most events occurred after 25 yrs of donation. They also found out that smoking and obesity were among reducing factors in non donors. The percentage loss of remaining life years from donation was not very different in those with or without these risk factors.
The author concluded that these results confirms the importance of following the donors and identifying and treating the risk factors to prevent ESRD and improve donor survival.
2. What is the level of evidence provided by this article?
Level 3
This study was done basically to estimate the probable life time risk of CKD/ESRD.
It was done on patients who had nephrectomy with eGFR >60ml/min before proceeding to surgery. this study was solely dependent on previous studies.
To state that in conclusion there is increased risk of ESRD in donors compared to non- donors which reduces life expectancy by 0.5 to 1 year. The donors will be having greater risk of falling eGFR compared with non- donors.
Level of evidence II.
2- Live kidney donation was associated with an added risk of ESRD especially among those of male sex and black race. The added lifetime cumulative risk of ESRD varied from 1.135% in white female to 4.645% in black male .This translated to one added ESRD event for every 88 white female donors or one added ESRD event for every 22 black male donors.
3-Donors were projected to spend 50%–85%more time with an isolated low glomerular filtration rate CKD (CKD not associated with diabetes mellitus or proteinuria) compared with non-donors. Assuming the added propor- tion of time spent with isolated low glomerular filtration rate CKD had no increase in all-cause mortality rate, the loss of remaining life years was 0.551, 0.316, 0.682 and 0.721 for white male, white female, black male and black female, respectively. This corresponded to an overall per cent loss of remaining life years of 1.39%, 0.72%, 1.9% and 1.74% for white male, white female, black male and black female, respectively.
4-younger patients lost more potential years of life and had potentially greater risks of ESRD given longer exposure to reduced kidney function.However on a percentage basis, loss of life was greater in older compared with younger donors.
5-Life expectancies were markedly reduced and lifetime risks of ESRD increased for cohorts who were smokers or had diabetes mellitus.
6-Obese patients were also at increased risk but less so compared with smokers and those with diabetes mellitus.
7- Surprisingly the absolute loss of life years was slightly less in donors who were obese or smoked compared with donors without these conditions.
8- Donors with diabetes mellitus suffered the greatest loss of life years and increased risk of ESRD.
9-Non-biological relationship to the recipient was associated with much lower loss of life years and risk of ESRD compared with those who were biologically related .
Disscusion :
In this study they show that donation potentially shortens life in aver- age-age donors by about 1%–2%. This analysis shows that short-term studies (<20 years) even with appropriate normal controls are not likely to detect an adverse effect on survival. Although ESRD is associated with very high mortality rates, a significant per cent of the loss of life was associated with CKD not ESRD. The study also explored risk factors that can be associated with higher rates of death and ESRD such as smoking, obesity and biological relationship to the recipient.
The analysis suggests that counselling and inter- ventions to reduce weight and smoking cessation are more important to both donor and non-donor and less of an argument to deny donation. Having a non-biological rela- tionship to the recipient was associated with lower risks; however, the majority of donors are related.5 Donors with diabetes mellitus were at very high added risks of ESRD and death.
Limitations to the study:
1-They used data from ESRD over 15 years in actual donors and a theoretical matched cohort to calculate lifetime outcomes.11 Life expectancy and the cumulative incidences of diabetes mellitus and ESRD are increasing. Using historic mortality and disease incidence rates to make accurate future lifetime projections is a significant limitation.
2-The study was an analysis of US donors, whereas the non-donor control population included US and international population.
3-did not include multiple stages of CKD.
4-the overall estimates of life loss associated with donation are between 0.5 and 1 year. There however appear to be some paradoxes in the analysis. As noted the absolute loss of life was higher in younger donors but a greater percentage of loss of life in older donors and they were not included.
5-The absolute loss of life years was less in obese and smoking donors than in otherwise ideal donors largely because the overall remaining life years were much shorter in donors with these risks.
6-No data on family history of ESRD in the non-biological-related donors. There may be some non-biological-related donors with a family history of kidney disease, which would put them at higher risk.
Conclusion:
Live kidney donation may reduce life expectancy by 0.5–1 year in most donors.
A lot of risk factors may affect life expectancy rather than ESRD ,following donors is essential step to avoid any preventable risk factor or to control any risk factors that may lead to ESRD like -ost donation DM ,HTN.
Level of evidence 2
One of the most important question that we will face in transplantation center is what is the long term out come of kidney donation ? what is the risk of having ESRD or even life span expectancy ?
So this study was found to estimate the potential loss of life as well as the added lifetime risk of ESRD in average risk kidney donor
Method
Conclusion
ollowing are the key assumptions for the model:
level of evidence : 2
▪︎Summary of the article
-This study was done to determine the potential loss of life in years and risk of end-ESRD from live kidney donation.
-risks to the donors are felt to be small to moderate,and proper screening and selection of donors decreases the long term donors risk.
-But still there is some reports showed that kidney donors are at risk of increase incidence of end-stage renal disease , and increase in cardiovascular mortality.
-donors also become at risk of developing chronic kidney disease (CKD) as defined as low GFR of <60mL/ min/1.73m2 or proteinuria.
– it was found also that some donors devoloped DM and may be at higher risk of developing hypertension.
▪︎Target cases were 40-year-old patients of both sexes and white/black race from the USA,mean age of live donors (median age 38) .
▪︎Results:
-percent loss of life was highest in black male donors.
-percent loss of life varied from 1.20% for white female to 2.34% for black male.
– percent loss of total QALYs varied from 0.76% for white female to 1.51% for black male.
–risk of ESRD was higher in male sex and black race.
-added lifetime cumulative risk of ESRD varied from 1.135% in white female to 4.645% in black male.
– younger patients lost more potential years of life and had potentially greater risks of ESRD given longer exposure to reduced kidney function.
-donors with DM had greater risk of ESRD.
▪︎Strength of the study
▪︎limitations of the study
-rely on the observed rates of ESRD over 15 years in actual donors and a theoretical matched cohort to calculate lifetime outcomes.
-analysis of US donors, and the non-donor control group included US and international populations.
-model did not include multiple stages of CKD.
–using a uniform cohort of 40-year-old individuals in the baseline analysis, whereas the information available is from a cohort of donors with a wide range of ages.
▪︎Conclusion
-Live kidney donation may reduce life expectancy by 0.5–1year in most donors.
-ESRD in donors is not the only measure of risk.
– most of life loss happened before reaching ESRD.
-longer follow up of donors and treating risk factors aggressively is very important to prevent ESRD and to improve donor survival.
Cohort study level of evidence II
· Recent reports indicated that donation may increase the risk of ESKD and cardiovascular mortality
· Some donors may develop DM or HTN in spite of being screened before donation, which increases the risk of CKD and resultant ESKD
· The aim of this study is to estimate the potential loss of life as well as the added lifetime risk of ESRD in average-risk kidney donors
Methods
· A USA-based Markov model was used to examine the risk of ESRD in a population of non-donors and donors
· A previously published studies was updated to include recent general population and ESRD vital statistics, and recent cumulative risks of DM, CKD and ESRD from published sources
· There
· were no involved patients in the study
Target population
· 40-year-old patients of both sexes and white/black race from the USA. This is the mean age of live donors (median age 38) and for whom there are recent published estimates of 15-year cumulative risks of ESRD in non-donors and donors
Results
· The donation leads to loss of 0.532 years for white female and 0.884 years for black female donors.
· The loss of life was highest in black male donors.
· The loss of life varied from 1.20% for white female to 2.34% for black male.
· The loss of total QALYs varied from 0.76% for white female to 1.51% for black male
· The added lifetime cumulative risk of ESRD varied from 1.135% in white female to 4.645% in black male
· More than 50% of all ESRD events in donors occurred 25 years or more after donation.
· The added ESRD events tended to occur earlier in black male compared with white male
· Donors were estimated to spend 50%–85%more time with an isolated low GFR CKD compared with non-donors
· loss of life was greater in older compared with younger donors
· Unexpectedly, the absolute loss of life years was slightly less in donors who were obese or smoked compared with donors without these conditions
· Donors with DM had the greatest loss of life years and increased risk of ESRD
Strength of the study:
· Estimated the long-term risk of donating a kidney, including loss of life and the added risk of end-stage renal failure.
· The donors may be informed about the results, which hold a risk od donation and the need for follow up post donation
· The study uses evidence of over 15 years of followup in actual live kidney donors and healthy controls.
Limitation:
· The ability to predict lifetime outcomes from 15- year follow-up in donors of all ages and medical conditions
· The study was an analysis of US donors, whereas the non-donor control population included US and international populations
· The results could not applicable to live kidney donors from other countries where population ESRD rates are much lower
· The model did not include multiple stages of CKD
CONCLUSION
· Donation potentially shortens life in average-age donors by about 1%–2%
· The affected survival, can not be detected with the short-term studies (<20years)
· Smoking, obesity and biological relationship to the recipient are associated with higher rates of death and ESRD
· Some donors may develop DM, hypertension and proteinuria later on, and these may affect overall survival and progression to ESRD
· To estimate the effect of donation truly, more information is needed, and large numbers of patients and controls and long-term follow-up are needed to estimate with different variables
What is the level of evidence provided by this article?
This is a retrospective cohort study (level III)
Aim: To estimate the potential loss of life as well as the added lifetime risk of ESRD in average- risk kidney donors.
Study design: Markov medical decision analysis
Participants 40-year-old live kidney donors of both sexes
and black/white race in US undergoing live donor nephrectomy
Main outcome and measures Potential remaining life years lost, quality-adjusted life years (QALYs) lost and added lifetime cumulative risk of ESRD from donation.
Results
Conclusion Live kidney donation may reduce life expectancy by 0.5–1 year in most donors.
The donors should be followed up strictly post-donation and the risk factor factors should be treated aggressively to prevent ESRD in them, thus prolonging donor survival.
Limitations:
Level of evidence: Level II
Introduction
Around 30000 kidney donations is done yearly worldwide. The expected benefit is improving survival and quality of life for the recipients. However, there is a risk for the donor although it is small. With post operative mortality of around 3 per 10000 surgeries. On the long term also, the risk is estimated to be low, but some recent reports showed that risk of ESRD is increased.
The objectives of this study were to estimate the potential loss of life as well as the added lifetime risk of ESRD in average- risk kidney donors.
Methods
Model description
A USA-based Markov model was used to examine the risk of ESRD in a population of non-donors and donors.
Target population
The base case cohorts were 40-year-old patients of both sexes and white/black race from the USA. This is the mean age of live donors (median age 38) and for whom there are recent published estimates of 15-year cumulative risks of ESRD in non-donors and donors.
Main outcome measures
The health outcome of interest was remaining years of life.
Intervention effects
Donors in the study underwent unilateral nephrectomy. It is assumed that the nephrectomy results in a loss of GFR, and this loss of function would increase the probability of transitioning from a normal (GFR ≥60 mL/min/1.73 m2) kidney function heath state to CKD.
Results
Differences in survival starts to appear after 20 years or more from donation. The remaining life years lost from donation ranged between 0.532 years for white female to 0.884 years for black female donors.
The per cent loss of life was highest in black male donors. The per cent loss of life varied from 1.20% for white female to 2.34% for black male. The per cent loss of total QALYs varied from 0.76% for white female to 1.51% for black male. Those with diabetes has more loss than others.
The added lifetime cumulative risk of ESRD varied from 1.135% in white female to 4.645% in black male. This translated to one added ESRD event for every 88 white female donors or one added ESRD event for every 22 black male donors.
Discussion
This study showed that the remaining life lost because of donation range from 1-2%. It is higher in black male and lowest in white female. If we compared this with life lost due to smoking and mild obesity the late are costing more. Compared with live part of liver donation, despite higher perioperative mortality in liver donation 1.7 per 1000 versus 0.31 per 1000 kidney donations, there is no long-term life loss in the liver donors.
This study also highlighted the importance of long time follow up, as the risk of CKD and ESRD appears after 25years. This means that studies with shorter duration will easily missed this risk.
Limitations
1. Limitation of modelling future events.
2. We rely on the observed rates of ESRD over 15 years in actual donors and a theoretical matched cohort to calculate lifetime outcomes.
3. Life expectancy and the cumulative incidences of diabetes mellitus and ESRD are increasing.
4. Using historic mortality and disease incidence rates to make accurate future lifetime projections. however,
5. The study was an analysis of US donors, whereas the non-donor control population included US and international populations.
Level 11
The most important question asked by donors is always what is my life time risk of developing kidney disease?
Kiberd and Tennankore have tried to answer this question by conducting this study to estimate the potential loss of life and the lifetime cumulative risk of end-stage renal disease (ESRD) from live kidney donation by using Markov medical decision analysis.
The study was conducted in USA and 40-year-old live kidney donors of both sexes and black/white race were included.
Main outcome and measures were Potential remaining life years lost
quality-adjusted life years (QALYs) lost and
added lifetime cumulative risk of ESRD from donation.
The following are the key assumptions for the model:
ESRD rates are increased in donors compared with non-donors.
ESRD in both donors and non-donors will be associated with high mortality rates.
Nephrectomy in donors will quantitatively reduce overall patient kidney function.
Cohorts are assumed to be free of hypertension, diabetes mellitus and proteinuria at donation.
CKD states will be associated with higher mortality rates as in the general population.
In this study they show that donation potentially shortens life in average-age donors by about 1%–2%.
This analysis shows that short-term studies (<20 years) even with appropriate normal controls are not likely to detect an adverse effect on survival.
Based on current literature it is unclear whether there is a significant risk of death from donation
Live kidney donation may reduce life expectancy by 0.5–1 year in most donors.
The development of ESRD in donors may not be the only measure of risk as most of the predicted loss of life predates ESRD.
The study identifies the potential importance of following donors and treating risk factors aggressively to prevent ESRD and to improve donor survival.
Retrospective study
level 2
The aim of this study is to demonstrate the living donor’s:
1- potential loss of life
2- loss of lifetime cumulative risk of ESRD
this study follows the Makov medical decision analysis design
following are the key assumptions for the model:
Results;
Differences in survival between the cohorts became apparent after 20 year
The per cent loss of total QALYs varied from 0.76% for white female to 1.51% for black male.
Live kidney donation was associated with an added risk of ESRD especially among those of male sex and black race.
The per cent loss of life attributed to ESRD in relation to total remaining years of life varied between 0.29% for white female and 0.88% for black male
Assuming the added proportion of time spent with isolated low GFR CKD had no increase in all-cause mortality rate
younger patients lost more potential years of life and had potentially greater risks of ESRD given longer exposure to reduced kidney function.
However on a percentage basis, loss of life was greater in older compared with younger donors.
lifetime risks of ESRD increased for cohorts who were smokers or had diabetes mellitus.
Obese patients were also at increased risk but lesser
Non-biological relationship to the recipient was associated with much lower loss of life years and risk of ESRD compared with those who were biologically related.
Conclusion
Asking donors whether they may be willing to give up between 0.5 and 1 year of life may be a better way to convey risk than giving them an estimate of their lifetime risk of ESRD.
In addition the study identifies the potential importance of following donors and treating risk factors aggressively to prevent ESRD and to improve donor survival
limitation of this study
The ability to predict lifetime outcomes from 15year follow-up in donors of all ages and medical conditions is a limitation.
Level of evidence is 2
This is a retrospective cohort study – level IIb.
It used a model called Markov medical decision analysis using the American position at age 40 including gender or ethnicity. The intention of the study is to define whether there is a difference in the prognosis of living donors who underwent nephrectomy based on sex or ethnicity. The main objectives were to assess years of potential life lost, adjusted loss of years lost, and cumulative risk of end-stage renal disease.
The analysis was performed in comparison with a population with the same characteristics as the donor, having the healthy behavior of a potential donor.
The results showed that the difference in survival in the cohorts only occurred after 20 years after donation. Men of black ethnicity had the worst survival rates, including considering QUALYs. The same occurs with ESRD, where most cases occurred within 25 years or more of donation.
Even in different sexes, black women (1.74%) are at higher risk than white men (1.39%) when compared to black men (1.9%). In other analyses, young people were at greater risk of donating. Diabetes and smoking are other risk factors, the former being the worst. Obesity may have some related potential, but it is inferior to the previous two.
This study showed that the loss of life potential ranges from 1 to 2%, being more related to chronic kidney disease and not end-stage renal disease. These risks were different depending on ethnicity (whites 1 in 28 / blacks 1 in 22). This study suggests smoking cessation associated with weight loss in those with a BMI greater than 30.
Introduction
There is a very low risk of developing CKD in kidney donors may be due to the risk of developing hypertension, DM, and proteinuria which may affect the remained kidney.
Target population
40-year-old patients ( males and females ) (black and white ) with median age 38 years old.
Study Design and outcome:
Study of the rate of developing ESKD in both groups (donor and non-donors) in addition to studying of loss of life after developing ESKD in different groups and rate of developing of DM, HTN, and proteinuria and effect on CKD progression.
15 years risk of development of ESKD in non-donor groups were Respectively :
0.067%, 0.045%, 0.21% and 0.12% for white male, white female, black male and black female.
15 years risk of development of ESKD in donor groups were Respectively :
0.34%, 0.15%, 0.96% and 0.59% for white male, white female, black male and black female .
Results :
The percent of life loss was the highest among the black male donors of 2.34% and the least among white female donors 0.532 years.
Increase the risk of ESKD on black male donors 4.645% and 1.135% for white female donor
More than 50 % of ESKD occurs after 25 years of kidney donation.
Young donors were more exposed to ESKD and more life loss due to long-time exposure with less glomerular filtration rates.
Diabetic donors had the highest risk for developing ESKD with more loss of life after ESKD.
Discussion :
Kidney nephrectomy of Donors decreases life in average-age donors by an average ( 1%–2%).
The risk of ESKD and death was higher with these risk factors (DM, Obesity, and Biological relationship with recipients )
CKD was associated with an increased risk of death mostly due to increased risk of cardiovascular disease and longer time till progression to ESKD.
Life lost from CKD was high from a life lost on ESKD.
This may be due to the probability of DM, Proteinuria, Obesity, and hypertension affecting the donors which increase the rate of cardiovascular and ESKD and even may the highest risk of progression of ESKD in both donors and non–donors.
Counseling for Both decreasing weight and stopping of smoking is very important for both groups to decrease the risk of CKD.
Non- biological relationships of donors were associated with fewer risk factors for ESKD.
Limitations of the study :
donors were from the US however non-donors were from the Us and International.
The observation period was 15 years and a theortical-matched study was used to calculate lifetime
The model didn’t include different stages of CKD.
Level of evidence II
Life expectancy is associated with ESRD development and the increase of cardiovascular diseases
The study showed that 1%–5% of average-age current live kidney donors might develop ESRD as a result of nephrectomy. The added risk of ESRD resulted in a loss of only 0.126–0.344 remaining life years. Most of the loss of life was predicted to be associated with chronic kidney disease (CKD) not ESRD. Most events occurred 25 or more years after donation. Reducing the increased risk of death associated with CKD had a modest overall effect on the per cent loss of remaining life years (0.72%–1.9%) and QALYs (0.58%–1.33%).
However the percentage loss of remaining life years from donation was not very different in those with or without these risk factors.
conclusion
Live kidney donation may reduce life expectancy by 0.5–1 year in most donors. The development of ESRD in donors may not be the only measure of risk as most of the predicted loss of life predates ESRD. The study identifies the potential importance of following donors and treating risk factors aggressively to prevent ESRD and to improve donor survival.
Recent reports however show that there is some increase in risk of end-stage renal disease (ESRD) from donation and possibly an increase in cardiovascular mortality. 5 6 Patients who donate a kidney may be at greater risk of developing chronic kidney disease (CKD) as defined by a low glomerular filtration rate (GFR) of <60 mL/ min/1.73 m 2 or proteinuria. 7 Furthermore, some donors will develop diabetes mellitus at a later date despite being screened and may be at higher risk of developing hypertension. 8 9 These conditions could accelerate the loss of kidney function and increase the risk of ESRD. CKD is associated with an increase in risk of progression to ESRD and an increase in predialysis mortality.
Recent reports however show that there is some increase in risk of end-stage renal disease (ESRD) from donation and possibly an increase in cardiovascular mortality. 5 6 Patients who donate a kidney may be at greater risk of developing chronic kidney disease (CKD) as defined by a low glomerular filtration rate (GFR) of <60 mL/ min/1.73 m 2 or proteinuria. 7 Furthermore, some donors will develop diabetes mellitus at a later date despite being screened and may be at higher risk of developing hypertension. 8 9 These conditions could accelerate the loss of kidney function and increase the risk of ESRD. CKD is associated with an increase in risk of progression to ESRD and an increase in predialysis mortality.
MethODs
Model description
The following are the key assumptions for the model: ► ESRD rates are increased in donors compared with non-donors.11
► ESRD in both donors and non-donors will be associated with high mortality rates.
► Donor and non-donors transition through a CKD state for at least 1 year before developing ESRD.
► Since ESRD rates are increased in donors compared with non-donors, we assumed there must have been an increase in the rate of transition to and time spent in CKD states.
► Nephrectomy in donors will quantitatively reduce overall patient kidney function. Given that kidney function declines over time in most individuals, donors will have a greater risk of falling below a GFR threshold of 60 mL/min/1.73 m 2 compared with non-donors.
► Cohorts are assumed to be free of hypertension, diabetes mellitus and proteinuria at donation. However they are at risk of developing these conditions whether they donate or not, and these will impact patient survival and loss of kidney function in both donors and non-donors.
uncertainty and sensitivity analyses
We assumed that many future risks that can impact on life expectancy and ESRD such as cancer, obesity, smoking and so on were not influenced by the act of kidney donation. The lifetime estimates of ESRD were found to be higher in non-donors than published estimates, in part since this model incorporated the possibility that some participants could develop diabetes mellitus and proteinuria.
In other sensitivity analyses age at donation, smoking status, higher body mass index, new-onset diabetes mellitus and biological relationship to recipient were explored.
results
Baseline analysis
Differences in survival between the cohorts became apparent after 20 years or more after donation.
The per cent loss of life varied from 1.20% for white female to 2.34% for black male. The per cent loss of total QALYs varied from 0.76% for white female to 1.51% for black male.
Live kidney donation was associated with an added risk of ESRD especially among those of male sex and black race.
More than 50% of all ESRD events in donors occurred 25 years or more after donation.
In a variety of subgroup analyses younger patients lost more potential years of life and had potentially greater risks of ESRD given longer exposure to reduced kidney function.
Surprisingly the absolute loss of life years was slightly less in donors who were obese or smoked compared with donors without these conditions. Donors with diabetes mellitus suffered the greatest loss of life years and increased risk of ESRD.
The mechanism by which low glomerular filtration rate CKD is associated with an increase in cardiovascular and all-cause mortality rate is not completely known.
Level II
Introduction
The risks to the donors are generally felt to be small to modest, with a low postoperative mortality (approximately 3.1 deaths per 10 000 operations)
The long-term risks are also presumed to be small especially in low-risk donors who are adequately screened.
Patients who donate a kidney may be at greater risk of developing chronic kidney disease (CKD) as defined by a low glomerular filtration rate (GFR) of <60 mL/ min/1.73 m2 or proteinuria.
Furthermore, some donors will develop diabetes mellitus at a later date despite being screened and may be at higher risk of developing hypertension.
These conditions could accelerate the loss of kidney function and increase the risk of ESRD. CKD is associated with an increase in risk of progression to ESRD and an increase in predialysis mortality.
Those with minor medical abnormalities, men and individuals of black race had greater 15-year and lifetime risks of ESRD.
Methods
Model description
A USA-based Markov model was used to examine the risk of ESRD in a population of non-donors and donors.
Patient involvement in study design
The study design, development and research question did not involve patient input, nor were outcomes informed
by patient priorities. There was no patient recruitment or participation in this study but rather the study relied on prior published analyses.
Target population
The base case cohorts were 40-year-old patients of both sexes and white/black race from the USA. This is the mean age of live donors (median age 38) and for whom there are recent published estimates of 15-year cumulative risks of ESRD in non-donors and donors.
Intervention effects
Donors in the study underwent unilateral nephrectomy. It is assumed that the nephrectomy results in a loss of GFR, and this loss of function would increase the probability of transitioning from a normal (GFR ≥60 mL/min/1.73 m2) kidney function heath state to CKD.
Results and discussion
this study show that donation potentially shortens life in average-age donors by about 1%–2%. This analysis shows that short-term studies (<20 years) even with appropriate normal controls are not likely to detect an adverse effect on survival.
The study also explored risk factors that can be associated with higher rates of death and ESRD such as smoking, obesity and biological relationship to the recipient. The mechanism by which low glomerular filtration rate CKD is associated with an increase in cardiovascular and all-cause mortality rate is not completely known. Based on current literature it is unclear whether there is a significant risk of death from donation, but studies have had relatively small numbers, only 0.2% lower than a non-donor
This model incorporated the probability that some donors will develop diabetes mellitus, hypertension and proteinuria at a later date, and these would impact on health (overall survival and progression to ESRD) as they do in the general population. The model could have been simplified if these risk factors for CKD and ESRD were not included in the model, but this would not reflect reality.
The baseline analysis also showed that white males suffer greater added long-term ESRD risks from donation than would be anticipated. For white male the added risk of an ESRD event was 1 for every 28 donors. For black male the risk was 1 in 22. One would have expected the added risk of ESRD in white male to be less than half the added risk in black male from what is known in the general population
The analysis suggests that counselling and interventions to reduce weight and smoking cessation are more important to both donor and non-donor and less of an argument to deny donation. Having a non-biological relationship to the recipient was associated with lower risks; however, the majority of donors are related.5 Donors with diabetes mellitus were at very high added risks of ESRD and death
The model did not include multiple stages of CKD. A more complex model could have been generated to differential stages 3a, 3b, 4 and 5 multiplied by three levels of proteinuria. However this would complicate the model and we do not have enough patient-level data to examine this in detail.
As noted the absolute loss of life was higher in younger donors but a greater percentage of loss of life in older donors. These result from a fixed relative risk of death associated with CKD multiplied by low baseline death rates in the young compared with higher death rates in older subjects along with differences in exposure
There is no data on family history of ESRD in the non-biological-related donors. There may be some non-biological-related donors with a family history of kidney disease, which would put them at higher risk. In addition we assumed that the relative risks between white and black of both sexes with a biological relationship were the same.
Conclusion
More information is required before we can truly estimate the impact of live kidney donation. Given the need for large numbers of patients and controls and long term follow-up, this risk may never be accurately measured for all age, race, sex and those with minor medical abnormalities. Given the above, estimating lifetime ESRD rates in non-donors may not be the best or only metric to inform the risk of donation.11 Greater efforts to put risk into context for potential donors in the face of uncertainty for any one individual donor. Asking donors whether they may be willing to give up between 0.5 and 1 year of life may be a better way to convey risk than giving them an estimate of their lifetime risk of ESRD.
level II
In this study found to have increase risk of ckd and ESRD in donor group compare to non donor .
it is also showed increase of multiple risk factors .
This study showed shorten life of to 1 to 2 5 in donor group in to complain to non donor group .
Young age donor is at greater risk of having ESRD
THE LEVEL s cohort level 2
Please summarise this article in your own words
-The recent reports show that there is some increase in risk of end-stage
renal disease (ESRD) from donation and possibly an increase in cardiovascular
mortality.
-Patients who donate a kidney may be at greater risk of developing chronic
kidney disease , diabetes mellitus and hypertension.
– Donor with minor medical abnormalities, men and individuals
of black race had greater 15-year and lifetime risks of ESRD.
– objectives of this study were to estimate the potential loss of life as well as the added lifetime risk of ESRD in average- risk kidney donors.
– Although ESRD is associated with very high mortality rates, a significant per cent of the loss of life was associated with CKD not ESRD.
– The per cent of patients modelled to be alive at 20 years post nephrectomy for an average-age white male donor was only 0.2% lower than a non-donor .
– About 78% of the loss of all QALYs from donation was associated with CKD in white female, whereas the loss was 58% in black male.
– The baseline analysis showed that white males suffer greater added long-term ESRD risks from donation than would be anticipated.
– The loss of life from live kidney donation is projected to be
far less than smoking or mild obesity .
– The live partial liver donation may be less risky over the long run compared
with live kidney donation.
-Despite a higher postoperative mortality with partial live liver donation, kidney donation results in more loss of life when adding in the long-term impact.
– The life years lost from donation are greater than the life years gained from colorectal cancer screening in an average-risk person.
-The younger donors have greater added risks of ESRD and potential life years lost; however, the percentage loss of life was somewhat less compared with older cohorts.
-The effect of smoking and diabetes mellitus had large effects on overall survival and in lifetime risks of ESRD in donors and non-donors. The effects were less in obese donors compared with donors who were smoking or had diabetes mellitus. – Donors with diabetes mellitus were at very high added risks of ESRD
and death. A40-year-old white female with diabetes mellitus, who is otherwise well, has about the same added risk of ESRD and percentage loss of life years as a current ideal 40-year-old black male donor.
– Since donors eventually have a greater risk of entering into a more
advanced CKD state, this analysis may have underestimated the overall net loss of life years from nephrectomy.
-There is no data on family history of ESRD in the non-biological-related donors.
What is the level of evidence provided by this article?
Level 2
Thank you
The article highlights the long term effects of kidney donation in terms of QALYs lost in predominantly American population. The authors have used strong statistical tools to retrospectively analyse the effects of donation, which scores very well in favour of living kidney donation. The key take home messages would be that long term morbidity and mortality pointers only appear after 20-30 years of follow up and living kidney donations are extremely safe, provided the donors adapt a healthy lifestyle.
This is a very short reply, unless you summarised it in the last week
It is an observational retrospective cohort study that has used historical population based control. Donation reduced life by 1-2% which is comparatively less as compared to smoking and obesity. Nonetheless younger donors have increased risk of ESKD
This is a very short reply, unless you summarised it in the last week
Lifetime risks of kidney donation: a medical decision analysis
▪︎The objectives of this study were to estimate the potential loss of life as well as the added lifetime risk of ESRD in average-risk kidney donors.
♧Introduction:
▪︎Patients who donate a kidney have an increase in risk of ESRD, cardiovascular mortality, CKD as defined by a low GFR of <60mL/min/1.73m2 or proteinuria, DM and hypertension.
Methods:
Target population: 40-year-old patients of both sexes and white/black race from the USA.
Intervention: Donors who underwent unilateral nephrectomy.
Design: Markov medical decision analysis.
All analyses compared outcomes of the same population of healthy potential donors and modelled the effects if all donated.
Primary outcomes: the net difference in remaining life years, QALYs and development of ESRD.
Results-
Risk of ESRD is higher in donors as compared to non donors.
Donation can decrease life up to a year- Overall the 1.2-2.3% remaining years were lost.
Most of the loss of life was associated with CKD and not ESRD
The risk is higher in males, blacks, family relatives , if high BMI and smokers.
Most of the events occurred 25 years post donation
Conclusion
Donation reduced life by 1-2% in a 40-year-old donor but this reduction is lower than what is caused by smoking and obesity. In the sub-analysis, the younger population of patients had more life years lost and had a higher risk of developing ESKD.
Limitations:
The studies included had small numbers and short-term follow-up (around 15y).
Donors from US and the control group (non-donor) included international populations.
What is the level of evidence provided by this article?
Cohort study Level 2
Thank you, Maksuda
I can see a significant improvement in your performance; well done.
Lifetime risks of kidney donation: a medical decision analysis
Please summarise this article in your own words
Historically studies have concluded that post kidney donation there is higher risk of diabetes , hypertension, chronic kidney disease, proteinuria as compared to healthy non donors.
These risk were noted to be higher in males as compared to females. There was higher risk in Blacks as compared to whites.
This study compared the risk of loss of life and ESRD in donors ( Blacks , whites, Males, Females) post donation when compared to matched healthy donors.
Target population – Over age 40 , blacks, whites, males and females in US
Design– Markov Medical Decision Analysis
Results-
Risk of ESRD is higher in donors as compared to non donors.
Donation can decrease life up to a year- Overall the 1.2-2.3% remaining years were lost.
Most of the loss of life was associated with CKD and not ESRD
The risk is higher in males, blacks, family relatives , if high BMI and smokers.
Most of the events occurred 25 years post donation
Conclusion
Post donation life can decrease by 1 year
Life style modification may improve outcomes including low risk of ESRD and improvement in longevity
What is the level of evidence provided by this article?
Cohort study Level 11
Thank you
The article’s name is Lifetime risks of kidney donation: a medical decision analysis. The objective of the study is to try to estimate the potential loss of life and the cumulative lifetime risk of kidney failure from living kidney donation. The risk of kidney failure from initial studies was small and the mortality was about 3.1 per 10000 operations but in the recent investigation, there has been an increase in ESRD from donation and as such an increase in CVD. It was also noted that some donors actually develop DM and this may predispose them to develop HTN. All the above risk factors increase the possibility of kidney failure.
The population that was targeted was 40 years old live kidney donors of different racial backgrounds and also different sexes. It was found that the risk of kidney failure was higher in males and the black race. It was noticed that about 1-5% of the average age of current live kidney donors may develop kidney failure secondary to nephrectomy. Most of the events happen around 25 years or more after the kidney donation. It was found that certain risk factors increase the risk of ESRD and they are:
1) Smoking
2) Obesity
3) DM
One of the interesting points that were noted was that younger live donors have a reduction in their life expectancy due to kidney failure the loss of life was greater in the older population. Also, DM patients had a much greater loss of life due to ESRD. The donors were expected to have a decreased GFR of about 50-85% when compared to non-donors.
So one can conclude from the article that live kidney donors had a reduction or reduced in their life expectancy and the risk was greater in black race and the male sex. It must be taken into consideration that the risk factors must be dealt with aggressively and treated to improve the donor’s survival rate.
I think that the level-based evidence is level 3.
Thank you
Lifetime risks of kidney donation: a medical decision analysis
Summary of the article
CKD is associated with multiple comorbidities and the noticed increased in mortality related to CKD is an important driver of life years lost.
In this study, a USA-based Markov model was used to examine the risk of ESRD in a population of non-donors and donors. There was no patient recruitment or participation in this study but rather the study relied on prior published analyses.
In this study, a sensitivity analysis was assumed that the added time spent in isolated CKD (no proteinuria nor diabetes mellitus) in donors compared with non-donors was not associated with an increase in mortality. In other sensitivity analyses age at donation, smoking status, higher body mass index, new-onset diabetes mellitus and biological relationship to recipient were explored.
The targeted population were 40-year-old patients of both sexes and white/black race from the USA.The time horizon for remaining life years and quality-adjusted life years (QALYS) was lifetime.
Study outcome
1. Differences in survival between the cohorts became apparent after 20 years or more after donation.
2. More than 50% of all ESRD events in donors occurred 25 years or more after donation.
3. The added lifetime cumulative risk of ESRD varied from 1.135% in white female to 4.645% in black male.
4. The per cent loss of life attributed to ESRD in relation to total remaining years of life varied between 0.29% for white female and 0.88% for black male.
5. On a percentage basis, loss of life was greater in older compared with younger donors. life was greater in older compared with younger donors.
6. Life expectancies were markedly reduced and lifetime risks of ESRD increased for cohorts who were smokers or had diabetes mellitus.
7. Surprisingly the absolute loss of life years was slightly less in donors who were obese or smoked compared with donors without these conditions.
8. Donors with diabetes mellitus suffered the greatest loss of life years and increased risk of ESRD.
9. The effect of smoking and diabetes mellitus had large effects on overall survival and in lifetime risks of ESRD in donors and non-donors.
10.Live kidney donation is found to be associated with less peri-operative death rate(0.31death/1000 operations in comparison to live liver donation(1.7/1000), but kidney donation results in more loss of life when adding in the long-term impact.
11.The non-biological relationship to the recipient was associated with lower risk.
Limitations of the study
1. Life expectancy and the cumulative incidences of diabetes mellitus and ESRD are increasing.
2. Using historic mortality and disease incidence rates to make accurate future lifetime projections is a significant limitation.
3. The study was an analysis of US donors, whereas the non-donor control population included US and international populations. The results may not be generalized to live kidney donors from other countries where population ESRD rates are much lower.
4. The model did not include multiple stages of CKD.
5. There was no data on family history of ESRD in the non-biological-related donors.
6. There are many variables and transition rates included in this model and addressing uncertainty in each.
7. Combinations of variables would require a much longer paper.
8. The key uncertainties explored were the cumulative risks of developing ESRD and the increased mortality associated with CKD states..
Strength of the study
1. Asking donors whether they may be willing to give up between 0.5 and 1year of life may be a better way to convey risk than giving them an estimate of their lifetime risk of ESRD.
2. The study identifies the potential importance of following donors and treating risk factors aggressively to prevent ESRD and to improve donor survival.
What is the level of evidence provided by this article?
This is a retrospective study .
Level of evidence is grade III.
Thank you, Safi. You are doing much better in this module compared to the last module.
INTRODUCTION
The benefits of improved life expectancy and quality of life are established in recipients post kidney transplantation but by achieving this are we risking the life of living kidney donors. This question is of utmost importance and need to have a evidence based and validated answer.
Hence, This study was conducted to estimate the potential loss of life years and quality adjusted life years (QALY) as well as life time risk of ESRD in kidney donor. The participants of this study were 40 year old live kidney donors of both black and white race and both sexes.
METHODS
A USA based theoretical model that uses published population data was unused to examine the risk of ESRD in donors and non-donors.
This theoretical modal had made few assumptions while conducting study:
Since the study design did not involve any patient recruitment or participation or actual patient inputs, the ethical approval was not needed. So the study population was extracted from previous published studies which met the inclusion criteria.
The target population was cohort of 40 year old patients of both sexes of black and white race from USA for whom recent published estimates of 15 year cumulative risks of ESRD in donors and non-donors were available.
Main outcomes
Results and Analysis
Non-donors – assumed to have 15-year cumulative ESRD risks of 0.067%, 0.045%, 0.21% and 0.12% for white male, white female, black male and black female, respectively.
Donors – assumed to have 15-year cumulative ESRD risks of 0.34%, 0.15%, 0.96% and 0.59% for white male, white female, black male and black female, respectively
Conclusions
Limitations
Strengths
Excellent Yashu
Thank you sir
Lifetime risks of kidney donation: a medical decision analysis
This is a retrospective cohort study (level III) in which prediction models are applied on published data to predict the remaining years of life, quality-adjusted life years, and cumulative incidence of developing ESKD in living kidney donors of age 40 years over 15 years of follow-up in comparison to non-donors utilizing Markov model.
The primary outcomes were:
· Remaining years of life
· QOL lost.
· Lifetime cumulative ESRD incidence
The outcomes measured included:
The projected survival was similar between donors and donors up to 20 years after which it was higher in the non-donors (more than 50% of ESRD occurred more than 25 years post-donation).
1. Remaining years of life: Loss of 1.2-2.34% of remaining life year. The risk of life loss was higher in males and African-Americans.
2. The percent loss of QOL was also highest in African American males and lowest in Caucasian females and the presence of CKD IS accounted for most of the reduction in QOL.
3. Lifetime cumulative ESRD incidence: 1-5%. Added risk of ESRD which associated with reduction of remaining years of life around 0.126-0.344 years.
Smoking, obesity, diabetes mellitus, and biologically related organ donation were associated with increased Lifetime cumulative ESRD incidence and loss of life.
It also noticed that non-donors with smoking and obesity are exposed to the risk of decreased life and increased ESRD more than the risk associated with a donation in the donors.
Conclusion
Donation reduced life by 1-2% in a 40-year-old donor but this reduction is lower than what is caused by smoking and obesity. In the sub-analysis, the younger population of patients had more life years lost and had a higher risk of developing ESKD.
Limitations:
The studies included had small numbers and short-term follow-up (around 15y).
Donors from US and the control group (non-donor) included international populations.
Thank you
Lifetime risks of kidney donation: a medical decision analysis
▪︎The objectives of this study were to estimate the potential loss of life as well as the added lifetime risk of ESRD in average-risk kidney donors.
♧Introduction:
▪︎Patients who donate a kidney have an increase in risk of ESRD, cardiovascular mortality, CKD as defined by a low GFR of <60mL/min/1.73m2 or proteinuria, DM and hypertension.
♧Methods
Model description
▪︎ A USA-based Markov model was used to examine the risk of ESRD in a population of non-donors and donors.
Participants 40-year-old live kidney donors of both sexes and black/white race.
Intervention Live donor nephrectomy.
Main outcome and measures Potential remaining life years lost, quality-adjusted life years (QALYs) lost and added lifetime cumulative risk of ESRD from donation.
♧Results
▪︎Overall 0.532–0.884 remaining life years were lost from donating a kidney. This was equivalent to 1.20%–2.34% of remaining life years (or 0.76%–1.51% remaining QALYs).
▪︎ The risk was higher in male and black individuals. The study showed that 1%–5% of average-age current live kidney donors might develop ESRD due to nephrectomy.
▪︎ The added risk of ESRD resulted in a loss of only 0.126–0.344 remaining life years.
▪︎Most of the loss of life was predicted to be associated with CKD not ESRD. ▪︎Most events occurred 25 or more years after donation. Reducing the increased risk of death associated with CKD had a modest overall effect on the per cent loss of remaining life years. ▪︎Smoking and obesity reduced life expectancy and increased overall lifetime risks of ESRD in non-donors. However the percentage loss of remaining life years from donation was not very different in those with or without these risk factors.
♧Strength of the study:
1. It had projected the long-term risk of donating a kidney, including loss of life and the added risk of ESRD. These fndings help quantify and communicate risk to potential donors and convey the importance of lifelong follow-up in actual donors.
2. The study have used evidence of over 15 years of followup in actual live kidney donors and healthy controls.
♧ Limitation:
1. The ability to predict lifetime outcomes from 15- year follow-up in donors of all ages & medical conditions
2. The study was an analysis of US donors, whereas the non-donor control population included US and international populations. The results may not be generalised to live kidney donors from other countries where population ESRD rates are much lower.
3. There are many variables and transition rates included in
this model and addressing uncertainty in each or combinations of variables would require a much longer paper.
4. The key uncertainties explored were the cumulative risks of developing ESRD and the increased mortality associated with CKD states. Lower risks of DM and proteinuria were also explored in ideal donors.
5. The model did not include multiple stages of CKD. Since donors eventually have a greater risk of entering into a more advanced CKD state, this analysis may have underestimated the overall net loss of life years from nephrectomy.
6. The study have used a uniform cohort of 40-year-old individuals in the baseline analysis, whereas the information available is from a cohort of donors with a wide range of ages.
Level of evidence: III
That is an excellent reply Dr Ashmaig,
It is an observational retrospective cohort study that has used historical population based control (with all its limitations).
I would call it level 2 rather than level 3.
If it were case-control study then it would be called level 3.
I am well aware that care-control studies have been kept with retrospective cohort by many thinkers.
1a:Systematic review (with homogeneity) of inception cohort studies; or a clinical decision rule validated in different populations.
1b:Individual inception cohort study with > 80% follow-up; or a clinical decision rule validated on a single population
1c:All or none case-series
2a:Systematic review (with homogeneity) of either retrospective cohort studies or untreated control groups in randomized controlled trials.
2b:Retrospective cohort study or follow-up of untreated control patients in a randomized controlled trial; or derivation of a clinical decision rule or validated on split-sample only
2c:”Outcomes” research
3a:Systematic review (with homogeneity) of case-control studies
3b:Individual case-control study
4:Case-series (and poor quality prognostic cohort studies)
5:Expert opinion without explicit critical appraisal, or based on physiology, bench research or “first principles”
Thank you v.much Prof Ajay for your reply and valuable informations… for sure I will keep it and revise.
Aim of the study:
To estimate the potential loss of life and the cumulative lifetime risk of ESRD from living kidney donation.
Methods:
Target population: 40-year-old patients of both sexes and white/black race from the USA.
Intervention: Donors who underwent unilateral nephrectomy.
Design: Markov medical decision analysis.
All analyses compared outcomes of the same population of healthy potential donors and modelled the effects if all donated.
Primary outcomes: the net difference in remaining life years, QALYs and development of ESRD.
Results:
Overall, 1.20%–2.34% of remaining life years were lost from donating a kidney.
The risk was higher in male and black individuals.
1%–5% of average-age current live kidney donors might develop ESRD as a result of nephrectomy.
The added risk of ESRD resulted in a loss of only 0.126–0.344 remaining life years.
Most of the loss of life was predicted to be associated with CKD, not ESRD.
Most events occurred 25 or more years after donation.
Reducing the increased risk of death associated with CKD had a modest overall effect on the per cent loss of remaining life years (0.72%–1.9%) and QALYs (0.58%–1.33%). Smoking and obesity reduced life expectancy and increased overall lifetime risks of ESRD in non-donors.
However, the percentage loss of remaining life years from donation was not very different in those with or without these risk factors.
Conclusion:
Live kidney donation may reduce life expectancy by 0.5–1 year in most donors.
The development of ESRD in donors may not be the only measure of risk, as most of the predicted loss of life predates ESRD.
The study identifies the potential importance of following donors and treating risk factors aggressively to prevent ESRD and to improve donor survival.
Level 3 (retrospective cohort study).
That is an excellent reply Dr Huda.
It is an observational retrospective cohort study that has used historical population based control (with all its limitations).
I would call it level 2 rather than level 3.
If it were case-control study then it would be called level 3.
I am well aware that care-control studies have been kept with retrospective cohort by many thinkers.
1a:Systematic review (with homogeneity) of inception cohort studies; or a clinical decision rule validated in different populations.
1b:Individual inception cohort study with > 80% follow-up; or a clinical decision rule validated on a single population
1c:All or none case-series
2a:Systematic review (with homogeneity) of either retrospective cohort studies or untreated control groups in randomized controlled trials.
2b:Retrospective cohort study or follow-up of untreated control patients in a randomized controlled trial; or derivation of a clinical decision rule or validated on split-sample only
2c:”Outcomes” research
3a:Systematic review (with homogeneity) of case-control studies
3b:Individual case-control study
4:Case-series (and poor quality prognostic cohort studies)
5:Expert opinion without explicit critical appraisal, or based on physiology, bench research or “first principles”
thank you Prof. Sharma
I. Lifetime risks of kidney donation: a medical decision analysis
Please summarise this article in your own words
Introduction
The risks to the donors are usually small to modest, with a low post-operative mortality (3.1 deaths/10 000 operations).
The long-term risks are also small especially in low-risk donors who are well screened. Recent reports show there is some increase in risk of ESRD from donation & possibly an increase in CV mortality.
Patients who donate a kidney may be at increased risk of developing CKD (GFR <60) or proteinuria.
Some donors will develop DM at a later date despite screening & may be at higher risk of developing HTN.
The objective of this study was to estimate the potential loss of life as well as the added lifetime risk of ESRD in average-risk kidney donors.
Methods
Model description
A USA-based Markov model was used to examine the risk of ESRD in a population of non-donors & donors.
The key assumptions for the model are:
·ESRD rates are increased in donors versus non-donors.
·ESRD in donors & non-donors will be associated with high mortality rates.
·Donor & non-donors go through a CKD state for at least 1 year before ESRD develops.
·Since ESRD rates are increased in donors versus non-donors, it is assumed there was an increase in the rate of transition to & time spent in CKD states.
·Nephrectomy will reduce overall kidney function. Donors will have a greater risk of falling below a GFR threshold of 60 mL/min compared with non-donors.
·Cohorts assumed to be free of HTN, DM & proteinuria at donation but are at risk of developing these conditions whether they donate or not, & these will impact patient survival & loss of kidney function in both groups.
·CKD states will be associated with higher mortality rates as in the general population.
·Model transition rates from normal to CKD states could be empirically derived to reproduce observed 15-year cumulative incidence rates for ESRD in donors & non-donors & can subsequently project lifetime cumulative risks of ESRD.
Patient involvement in study design
No patient recruitment or participation; the study relied on prior published analyses.
Target population
Case cohorts were 40-year-old (mean age of live donors, median age 38) patients of both sexes & white/black race from the USA.
Main outcome measures
The remaining years of life.
Life years were scaled by measures of quality & discounted at a 3% rate of time preference to calculate QALYs.
Lifetime cumulative incidence of ESRD was also calculated.
Intervention effects
Donors had unilateral nephrectomy & it is assumed that this results in a loss of GFR, & this would increase the probability of transition from a normal GFR (≥60) to CKD.
Time horizon
Lifetime.
For ESRD, the cumulative incidence truncated at age 90.
Outcomes
Primary outcomes:
The net difference in remaining life years, QALYs & development of ESRD.
Results
Differences in survival between the cohorts became apparent after =/>20 years after donation.
The remaining life years lost from donation is from 0.532 years (white female) & 0.884 years (black female donors).
The % loss of life was highest in black male donors.
The % loss of life varied from 1.20% (white female) to 2.34% (black male).
The % loss of total QALYs is from 0.76% (white female) to 1.51% (black male).
LKD was associated with an added risk of ESRD (especially male & black race).
> 50% of all ESRD events in donors occurred =/> 25 years after donation.
The % loss of life attributed to ESRD in relation to total remaining years of life is from 0.29% (white female) & 0.88% (black male).
Younger patients lost more years of life & had greater risks of ESRD (longer exposure to reduced kidney function); however, loss of life was greater in older versus younger donors.
Reduced life expectancy & increased lifetime risks of ESRD among cohorts who were smokers or had DM.
Donors with DM had the greatest loss of life years & increased risk of ESRD.
Non-biological relationship to the recipient associated with much lower loss of life years & risk of ESRD versus those who were biologically related.
Discussion
The short-term studies (<20 years) even with matched normal controls are not likely to detect an adverse effect on survival.
A significant % of the loss of life was associated with CKD not ESRD.
Death during the CKD state accounts for most of the projected increase in mortality & reduction in QALYs.
It is unclear whether there is a significant risk of death from donation; however, studies were small in size, lacked highly screened controls & of relatively short-term (<30 years) follow-up.
The % of patients modelled to be alive at 20 years post nephrectomy for an average-age white male donor was 0.2% lower than a non-donor.
78% of the loss of all QALYs from donation was associated with CKD in white female; the loss was 58% in black male.
White males have greater added long-term ESRD risks from donation than would be expected (1 for every 28 donors versus 1 in 22 for black males).
The loss of life from LKD is projected to be far less than smoking or mild obesity.
Live partial liver donation may be less risky over the long term compared with live kidney donation.
The life years lost from donation are more than the life years gained from colorectal cancer screening in an average-risk person.
Younger donors have greater added risks of ESRD & potential life years lost.
The effect of smoking & DM had large effects on overall survival & in lifetime risks of ESRD in donors & non-donors.
Counseling & interventions to reduce weight & smoking cessation are more important to both donor & non-donor & less of an argument to deny donation.
Donors with DM were at very high added risks of ESRD & death.
Limitations
Reliance on a theoretical matched cohort to calculate lifetime outcomes.
Historic mortality & disease incidence rates used to make accurate future lifetime rates.
The results may not be generalized to LKDs from countries other than the US.
Multiple stages of CKD were not included.
Conclusion
Asking donors whether they are ready to give up between 0.5 & 1 year of life may be a better way to show risk than giving them an estimate of their lifetime risk of ESRD.
The study identifies the importance of following donors & treating risk factors aggressively to prevent ESRD & to improve donor survival.
Because many of the risk factors develop years after donation, short-term follow-up of kidney donors may be inadequate.
=======================
What is the level of evidence provided by this article?
LEVEL III, retrospective cohort study
However, the reliance of the study on many assumptions makes me think that this is rather Level V, expert opinion
That is an excellent reply Dr Mohamed,
It is an observational retrospective cohort study that has used historical population based control (with all its limitations).
I would call it level 2 rather than level 3.
If it were casecontrol study then it would be called level 3. On the basis of discussion and expression of views, why would you call it level 5? The data and its analysis is the key, that is level 2.
I am well aware that care-control studies have been kept with retrospective cohort by many thinkers.
1a:Systematic review (with homogeneity) of inception cohort studies; or a clinical decision rule validated in different populations.
1b:Individual inception cohort study with > 80% follow-up; or a clinical decision rule validated on a single population
1c:All or none case-series
2a:Systematic review (with homogeneity) of either retrospective cohort studies or untreated control groups in randomized controlled trials.
2b:Retrospective cohort study or follow-up of untreated control patients in a randomized controlled trial; or derivation of a clinical decision rule or validated on split-sample only
2c:”Outcomes” research
3a:Systematic review (with homogeneity) of case-control studies
3b:Individual case-control study
4:Case-series (and poor quality prognostic cohort studies)
5:Expert opinion without explicit critical appraisal, or based on physiology, bench research or “first principles”
First of all, I am not sure about the evidence in this paper. To be honest, I had difficulty in summarizing it as evidence-based. I skimmed and scanned but did not find the number of cases included in the study, but I guessed from table one the number is the sum of (26+88+22+27: total 163? ). The model itself is something we are not familiar with but to summarize:
Life donation was found to have some risk in terms of CKD when defined as eGFR < 60 ml/min./1.73 m2. This was found to be higher post-donation. In terms of lost life years, it was -0.5- 0.884 the least in white females, but in average, the number is not high, and it is not easy to interpret for many reasons, one of them being the influence of multiple factors other than donating itself. the added cumulative risk was reported to be +1.35% in white females, which is nearly 3 times higher in white males and both black males and females). one important point here is the donors are American, but non-donors include non-Americans, which makes the generalizability difficult. The overall survival, as seen in figures 2-4, is not dramatically different between donors versus nondonor groups.
Good reply, Dr Islam.
1- Summary:
Objective: to estimate the potential loss of life and the lifetime cumulative risk of end-stage renal disease (ESRD) from live kidney donation.
Main outcome and measures: To Know the overall effect of donation on remaining life years and remaining quality-adjusted life years (QALYs) lost and added lifetime cumulative risk of ESRD from donation.
Target population: Participants of 40-year-old live kidney donors of both sexes and black/white race. Intervention Live donor nephrectomy.
Results:
· Overall, 0.532–0.884 remaining life years were lost from donating a kidney. This was equivalent to 1.20%–2.34% of remaining life years (or 0.76%–1.51% remaining QALYs). The risk was higher in male and black individuals.
· The per cent loss of total QALYs varied from 0.76% for white female to 1.51% for black male.
· 1%–5% of average-age current live kidney donors might develop ESRD because of nephrectomy. The added risk of ESRD resulted in a loss of only 0.126–0.344 remaining life years.
· Most events occurred 25 or more years after donation.
· Smoking and obesity reduced life expectancy and increased overall lifetime risks of ESRD in non-donors. However, the percentage loss of remaining life years from donation was not very different in those with or without these risk factors.
· Life expectancies were markedly reduced and lifetime risks of ESRD increased for cohorts who were smokers or had diabetes mellitus. Obese patients were also at increased risk but less so compared with smokers and those with diabetes mellitus.
· In a variety of subgroup analyses younger patients lost more potential years of life and had potentially greater risks of ESRD given longer exposure to reduced kidney function. However, on a percentage basis, loss of life was greater in older compared with younger donors.
· Donors with diabetes mellitus suffered the greatest loss of life years and increased risk of ESRD.
· Non-biological relationship to the recipient was associated with much lower loss of life years and risk of ESRD compared with those who were biologically related.
· Donors were projected to spend 50%–85%more time with an isolated low glomerular filtration rate CKD (CKD not associated with diabetes mellitus or proteinuria) compared with non-donors.
Conclusion:
· Live kidney donation may reduce life expectancy by 0.5–1 year in most donors.
· Live kidney donation was associated with an added risk of ESRD especially among those of male sex and black race.
· Risk factors should be treated aggressively to prevent ESRD and to improve donor survival.
2- Retrospective Case cohorts, level 3 evidence
That is an excellent reply Dr Alalawi.
Please use type in bold or underlining for headings and sub-headings. That makes it easier to read.
It is an observational retrospective cohort study that has used historical population based control (with all its limitations).
I would call it level 2 rather than level 3.
If it were case control study then it would be called level 3.
I am well aware that care-control studies have been kept with retrospective cohort by many thinkers.
1a:Systematic review (with homogeneity) of inception cohort studies; or a clinical decision rule validated in different populations.
1b:Individual inception cohort study with > 80% follow-up; or a clinical decision rule validated on a single population
1c:All or none case-series
2a:Systematic review (with homogeneity) of either retrospective cohort studies or untreated control groups in randomized controlled trials.
2b:Retrospective cohort study or follow-up of untreated control patients in a randomized controlled trial; or derivation of a clinical decision rule or validated on split-sample only
2c:”Outcomes” research
3a:Systematic review (with homogeneity) of case-control studies
3b:Individual case-control study
4:Case-series (and poor quality prognostic cohort studies)
5:Expert opinion without explicit critical appraisal, or based on physiology, bench research or “first principles”
Thank you
Introduction:
Patients who donate a kidney may be at greater risk of developing chronic kidney
disease (CKD) as defined by a low glomerular filtration rate (GFR) of
This risks thought before to be small with a low postoperative mortality (approximately
3.1 deaths per 10 000 operation.
Recent reports however show that there is some increase in risk of end-stage renal
disease (ESRD) from donation and possibly an increase in cardiovascular mortality.
Some donors will develop diabetes mellitus may be at higher risk of developing
hypertension. These conditions could precipitate loss of kidney function and increase the
risk of ESRD.
Objectives of this study:
To estimate the potential loss of life as well as the added lifetime risk of ESRD in
average-risk kidney donors.
Methods Model description:
A USA-based Markov model was used to examine the risk of ESRD in a population of
non-donors and donors. The transition from the normal health state through other health
states.
Key assumptions for the model:
ESRD rates are increased in donors compared with non-donors.
ESRD in both donors and non-donors will be associated with high mortality rates.
Donor and non-donors transition through a CKD state for at least 1year before
developing ESRD.
Since ESRD rates are increased in donors compared with non-donors.
Nephrectomy in donors will quantitatively reduce overall patient kidney function.
Patient involvement in study design:
The study relied on prior published analyses.
Target population:
The base case cohorts were 40-year-old patients of both sexes and white/black race
from the USA.
Main outcome measures:
Remaining years of life.
Calculate QALYs of life’
Lifetime cumulative incidence of ESRD was also calculated.
Intervention effects:
Donors in the study underwent unilateral nephrectomy. It is assumed that the
nephrectomy results in a loss of GFR.
Time horizon:
The remaining life years and QALYS was lifetime.
For ESRD, the cumulative incidence was truncated at age 90.
Results:
Life years lost from donation ranged between 0.532 years for white female and 0.884
years for black female donors. The percent loss of life was highest in black male donors.
The percent loss of total QALYs varied from 0.76% for white female to 1.51% for black
male.
Live kidney donation was associated with an added risk of ESRD especially among
those of male sex and black race.
The added lifetime cumulative risk of ESRD varied from 1.135% in white female to
4.645% in black male.
More than 50% of all ESRD events in donors occurred 25 years or more after donation.
ESRD is earlier in black male compared with white male.
The percent loss of life attributed to ESRD in relation to total remaining years of life
varied between 0.29% for white female and 0.88% for black male.
Donors were projected to spend 50%–85%more time with an isolated low glomerular
filtration rate CKD
Non-biological relationship to the recipient was associated with much lower loss of life
years and risk of ESRD compared with those who were biological.
Donors with diabetes mellitus suffered the greatest loss of life years and increased risk
of ESRD.
Conclusion:
In this study, we show that donation potentially shortens life in average-age donors by
about 1%–2%.
A significant percent of the loss of life was associated with CKD not ESRD.
Risk factors that can be associated with higher rates of ESRD AND DEATH:
As smoking, obesity and biological relationship.
Death during the CKD health state accounted for most of the projected increase in
mortality and reduction in QALYs.
About 78% of the loss of all QALYs from donation was associated with CKD in white
female, whereas the loss was 58% in black male.
Limitation:
Small size of patient.
Lacked highly scrutinized controls
Relatively short-term.
1. What is the level of evidence provided by this article?
Level of evidence 11.
Thank you
My goodness that is a superb reply, dear Dr Sobair. I can not improve upon this.
Please summarise this article in your own words
Aim of the study was to estimate the potential loss of life as well as the added lifetime risk of ESRD in average-risk kidney donors
The study used Markov model design examines the risk of ESRD in donors and non-donors. Assumptions for the model were:
* ESRD rates are increased in donors compared with non-donors
* ESRD in both donors and non-donors will be associated with high mortality rates
* Donor and non-donors transition through a CKD state for at least 1 year before developing ESRD
* The rate of transition to and time spent in CKD as ESRD rates are increased in donors compared with non-donors
* Nephrectomy reduce overall patient kidney function, so donors will have a greater risk of falling < GFR compared with non-donors
Donors are free of HTN, DM and proteinuria. However they are at risk of developing these conditions whether they donate or not, and these will impact patient survival and loss of kidney function in both donors and non-donors
There was no patient participation in this study (relied on prior published analyses). Case cohorts were 40-year-old patients of both sexes and white/black race from the USA. The main outcome was remaining years of life. The study underwent unilateral nephrectomy and the time for remaining life years and quality-adjusted life years was lifetime (for ESRD was at age 90)
All analyses compared outcomes of the same population of healthy potential donors and modelled the effects if all donated. Primary outcomes were remaining life years, quality-adjusted life years and ESRD
Differences in survival between the cohorts became apparent after 20 years or more after donation. The remaining life years lost from donation ranged between 0.532 years for white female and 0.884 years for black female donors. The loss of life was highest in black male donors. The loss of life varied from 1.20% for white female to 2.34% for black male
In this study donation shortens life in average-age donors by about 1%–2%. Although ESRD is associated with very high mortality rates, a significant per cent of the loss of life was associated with CKD not ESRD. Other risk factors may be associated with higher rates of death and ESRD (smoking, obesity and biological relationship to the recipient)
Limitation of the study is the ability to predict lifetime outcomes from 15- year follow-up in donors of all ages and medical conditions
What is the level of evidence provided by this article?
Level 2 (retrospective cohort study)
Thank you
Summary:
This cohort study of 40 years donors ( median age 38 ) with life time risk of ESRD/CKD, quality adjusted life years(QALY’s), and remaining years in life, compared donors and non donor whom underwent a thorough evaluation for donation. for 15 years follow up and to estimate the potential loss of life as well as the added lifetime risk of ESRD in average-risk kidney donor
Live kidney donation was associated with an added risk of ESRD specially among male and black population. The added lifetime cumulative risk of ESRD varied from 1.135% in white female to 4.645% in black male.
In a variety of subgroup analyses younger donors lost more potential years of life and had potentially greater risks of ESRD given longer exposure to reduced kidney function. However, on a percentage basis, loss of life was greater in older compared with younger donors.
Life expectancies were notably reduced and lifetime risks of ESRD increased for cohorts who were smokers or had DM. Obese had also increased risk but less so compared with smokers and those with DM. Surprisingly the absolute loss of life years was slightly less in donors who were obese or smoked compared with donors without these conditions. Donors with DM suffered the greatest loss of life years and increased risk of ESRD.
Level of evidence: level III
Thank you
The objectives; to estimate the potential loss of life as well as the added lifetime risk of ESRD in average-risk kidney donors.
Design; A USA-based Markov model was used to examine the risk of ESRD in a population of non-donors and donors.
The study relied on prior published analyses.
Target population; 40-year-old patients of both sexes and white/black race from the USA.
Intervention Live donor nephrectomy.
Main outcome and measures Potential remaining life years lost, quality-adjusted life years (QALYs) lost and added lifetime cumulative risk of ESRD from donation.
Time horizon The time horizon for remaining life years and QALYS was lifetime. However, for ESRD, the cumulative incidencewas truncated at age 90 in keeping with other studies.
Analysis; All analyses compared outcomes of the same population of healthy potential donors and modelled the effects if all donated.
Cohort assumed that donors were initially disease-free but could subsequently develop these conditions at rates seen in the general population.
Results:
Differences in survival between the cohorts became apparent after 20 years or more after donation.
The remaining life years lost from donation ranged between 0.532–0.884
This was equivalent to 1.20%–2.34% of remaining life years or (0.76%–1.51% remaining QALYs).
The risk was higher in male and black individuals.
The study showed that 1%–5% of average-age current live kidney donors might develop ESRD as a result of nephrectomy.
The added risk of ESRD resulted in a loss of only 0.126–0.344 remaining life years.
Most of the loss of life was predicted to be associated with chronic kidney disease (CKD) not ESRD.
Most events occurred 25 or more years after donation.
Death during the CKD health state accounted for most of the projected increase in mortality and reduction in QALYs. Intuitively this makes some sense given that the transition from CKD to ESRD can be over many years and that progressive kidney disease is associated with graded increases in mortality
Despite differences in the absolute rates of ESRD in both donors and non-donors, the absolute and percent loss of life years and QALYs from donation were only modestly lower compared with the base case analysis.
Smoking and obesity reduced life expectancy and increased overall lifetime risks of ESRD in non-donors.
However the percentage loss of remaining life years from donation was not very different in those with or without these risk factors.
Conclusion Live kidney donation may reduce life expectancy by 0.5–1 year in most donors. The development of ESRD in donors may not be the only measure of risk as most of the predicted loss of life predates ESRD. The study identifies the potential importance of following donors and treating risk factors aggressively to prevent ESRD and to improve donor survival.
Limitations of the study
– Using historic mortality and disease incidence rates to make accurate future lifetime projections is a significant limitation.
-The study was an analysis of US donors, whereas the non-donor control population included US and international populations. The results may not be generalized to live kidney donors from other countries where population ESRD rates are much lower.
-The model did not include multiple stages of CKD.
-There was no data on family history of ESRD in the non-biological-related donors.
-The key uncertainties explored were the cumulative risks of developing ESRD and the increased mortality associated with CKD states..
Strength of the study
Asking donors whether they may be willing to give up between 0.5 and 1year of life may be a better way to convey risk than giving them an estimate of their lifetime risk of ESRD.
What is the level of evidence provided by this article?
Level 2, observational longitudinal cohort study with population data as controls.
Thank you
Early studies have reported no or minimal risks associated with kidney donation in low risk, well-assessed kidney donors.
However, recent studies showed that there is some increase in risk of end-stage renal disease (ESRD) from donation and possibly an increase in cardiovascular mortality.
Recent studies reported following results:
– Greater risk of developing chronic kidney disease (CKD) as defined by a low glomerular filtration rate (GFR).
– Some donors will develop diabetes mellitus at a later date despite being screened and may be at higher risk of developing hypertension.
– A recent report projected the 15-year and lifetime risk of ESRD in potential non-donors to assist in counselling patients who are considering donation. Those with minor medical abnormalities, men and individuals of black race had greater 15-year and lifetime risks of ESRD.
The provided study estimated the potential loss of life and the lifetime cumulative risk of ESRD from live kidney donation.
Target population
The base case cohorts were 40-year-old patients of both sexes and white/black race from the USA.
Main outcome measures
The health outcome of interest was remaining years of life.
Results
– Differences in survival between the cohorts became apparent after 20 years or more after donation.
– The remaining life years lost from donation ranged between 0.532 years for white female and 0.884 years for black female donors. The per cent loss of life was highest in black male donors.
– The per cent loss of life varied from 1.20% for white female to 2.34% for black male.
In conclusion, kidney transplantation is the best treatment for potential recipients, however it may carry risk of ESRD, cardiovascular complications and reduction in remaining years of life. In the post donation period, donors should be followed up tightly for the remaining life time. Risk factors like obesity, smoking, hypertension and diabetes mellitus should be controlled to avoid progression of kidney disease
Thank you
#Please summarise this article in your own words
# Objective:
To evaluate the potential loss of life and the lifetime cumulative risk of (ESRD) from live kidney donation.
# Introduction:
*About 30 000 live donor kidney transplant surgeries are done throughout the world per year, which had advantage to recipients in improving life expectancy and quality of life when compared with dialysis or deceased donor transplantation.
* The risks to the donors are generally small to modest; with reduce the mortality rate after operation.
* The long-term risks are also presumed to be small especially in low-risk donors who are adequately screened, however recent studies show that there is some increase in risk of (ESRD) from donation and increase in cardiovascular mortality.
#Methods
#Model description
*A USA-based Markov model was used to examine the risk of ESRD in a population of non-donors and donors.
#The following are the key assumptions for the model:
*The incidence of ESRD rates are higher in donors compared with non-donors.
*In both donors and non-donors ESRD will be associated with high mortality rates.
* Donor and non-donors transition through a CKD state for at least 1 year before developing ESRD.
* As the ESRD rates are high in donors compared with non-donors, so there have been
an increase in the rate of transition to and time spent in CKD states.
* Nephrectomy in donors will quantitatively reduce overall patient kidney function.
(donors will have a greater risk of falling below a GFR threshold of 60 mL/min/1.73 m2 compared with non-donors).
* Cohorts are assumed to be free of HTN, DM and proteinuria at donation, but they are risky to developing these conditions whether they donate or not, and these will impact patient survival and loss of kidney function in both donors and non-donors.
*CKD states will be associated with higher mortality rates as in the general population.
* Model transition rates from normal to CKD states could be empirically derived to reproduce observed 15-year cumulative incidence rates for ESRD in donors and non-donors and can be used to subsequently project lifetime cumulative risks of ESRD.
# Results:
*Overall 0.532–0.884 remaining life years were lost from donating a kidney. This was equivalent to 1.20%–2.34% of remaining life years (or 0.76%–1.51% remaining QALYs).
*The risk was higher in male and black individuals.
The study showed that 1%–5% of average-age current live kidney donors might develop ESRD as a result of nephrectomy. The added risk of ESRD resulted in a loss of only 0.126–0.344 remaining life years. Most of the loss of life was predicted to be associated with chronic kidney disease (CKD) not ESRD.
*Most events occurred 25 or more years after donation. Reducing the increased risk of death associated with CKD had a modest overall effect on the per cent loss of remaining life years (0.72%–1.9%) and QALYs (0.58%–1.33%).
*Smoking and obesity reduced life expectancy and increased overall lifetime risks of ESRD in non-donors. However the percentage loss of remaining life years from donation was not very different in those with or without these risk factors.
# The strength and limitation:
*The study projects the long-term risk of donating a kidney, including loss of life and the added risk of end-stage renal failure.
* These findings help quantify and communicate risk to potential donors and convey the importance of lifelong follow-up in actual donors.
* The study uses evidence of over 15 years of follow up in actual live kidney donors and healthy controls.
*The ability to predict lifetime outcomes from 15- year follow-up in donors of all ages and medical conditions is a limitation.
# Conclusion
Live kidney donation may reduce life expectancy by 0.5–1 year in most donors. The
development of ESRD in donors may not be the only measure of risk as most of the predicted loss of life predates ESRD. The study identifies the potential importance of following donors and treating risk factors aggressively to prevent ESRD and to improve donor survival.
# What is the level of evidence provided by this article?
It is cohort study, prospective study level 2.
Thank you
Please summarise this article in your own words
cohort study for 40 years donors, life time risk of ESRD/CKD, quality adjusted life years(QALY’s), and remaining years in life, compared donors and non donor whom underwent a thorough evaluation for donation. for 15 years follow up.
Intervention: Donor nephrectomy.
Results:
The remaining years in life lost was higher among black male 2.35% in comparison to 1.2% in white females.(loss of life 0.88% black males to 0.29% white females
The risk of ESRD was higher in black males 4.645% compared to 1.135% in white females.
The (QALY’s) loss was more in back male also 1.51% in comparison to 0.76% in white females.
Being black male make the donor more prone to experience ESRD and decreased over all life time as well as QALY’s
The donors spend 50-85%more time with CKD(GFR <60 ml/min/1.73m2), not related to DM ,HTH, or proteinuria .
The absolute loss of life years was slightly less in donors who were obese or smoked.
Donors with diabetes mellitus suffered the greatest loss of life years and increased risk of ESRD.
Conclusion:
Asking donors whether they may be willing to give up between 0.5 and 1 year of life may be a better way to convey risk than giving them an estimate risk of ESRD.
The young white female donors have more favorable out comes.
Non-biological relationship to the recipient was associated with lower risk.
What is the level of evidence provided by this article?
Level of evidence II- Cohort study.
Thank you
Summary:
· Living kidney donation is associated with some long-term effects despite being well screened at time of donation and were free from diseases, the possible complications include:
o Risk of CKD progression.
o Small risk of higher mortality (detected years after donation) with 1-2 % shortage of expected life span (lower by 0.5-1 year).
o Risk of hypertension and proteinuria.
· The current study aims to evaluate the additional risk of mortality and CKD progression.
· As regard the risk factors of CKD progression, they include smoking, obesity and relation to the recipient.
· Mortality risk still has unclear etiology (not completely related to the risk of CKD). CKD defined as GFR less than 60 ml/min/1.72 m2.
· The risk of ESKD was associated with many risk factors as development of DM, HTN or proteinuria, in addition to male sex, black races and obesity.
Level of evidence : cohort study (level II).
sorry, level of evidence is III
Thank you