Mr John O'Callaghan, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion:
This is a report of a very complex and large study conducted across all transplant centres in Ontario, Canada. Randomization was done by CKD program, to permit the high level interventions that were being initiated.The multicomponent intervention was designed to address complex barriers at multiple levels that prevent kidney transplant and living donation. Support was provided from the central operations group, educational resources were made available and volunteer patients provided support. The primary outcome was assessed at the patient level and assessed the rate of steps completed towards live or deceased transplantation. 9780 patients entered the intervention group of the study during the 4 year inclusion period, and 10595 received usual care. Mean follow up was approximately 2 years. The step completion rate did not significantly differ between the intervention vs usual-care groups: 5334 vs 5638 steps; 24.8 vs 24.1 steps per 100 patient-years. There was also no significant difference in the secondary outcomes related to progress towards live donation. Despite a huge investment in monetary terms as well as professional time, and good uptake of interventions at both a program and patient level, there was no improvement in rate of progress towards renal transplantation. The COVID pandemic happened during the trial and is likely to have impacted on the delivery of the interventions. However, it highlights the difficulties of implementing a complex intervention in a healthcare system with multiple drivers and continuous staff turnover.
Aims:
The aim of this study was to investigate whether a multicomponent intervention was effective in improving patient access to kidney transplant and living kidney donation.
Interventions:
Chronic kidney disease (CKD) programs were randomised to either receive quality improvement intervention in addition to usual care or the usual care alone.
Participants:
26 CKD programs including 20375 potentially transplant-eligible patients with advanced CKD.
Outcomes:
The primary endpoint was the rate of steps completed toward receiving a kidney transplant.
Follow Up:
90 days
IMPORTANCE:
Patients with advanced chronic kidney disease (CKD) have the best chance for a longer and healthier life if they receive a kidney transplant. However, many barriers prevent patients from receiving a transplant.
OBJECTIVES:
To evaluate the effect of a multicomponent intervention designed to target several barriers that prevent eligible patients from completing key steps toward receiving a kidney transplant.
DESIGN, SETTING, AND PARTICIPANTS:
This pragmatic, 2-arm, parallel-group, open-label, registry-based, superiority, cluster randomized clinical trial included all 26 CKD programs in Ontario, Canada, from November 1, 2017, to December 31, 2021. These programs provide care for patients with advanced CKD (patients approaching the need for dialysis or receiving maintenance dialysis).
INTERVENTIONS:
Using stratified, covariate-constrained randomization, allocation of the CKD programs at a 1:1 ratio was used to compare the multicomponent intervention vs usual care for 4.2 years. The intervention had 4 main components, (1) administrative support to establish local quality improvement teams; (2) transplant educational resources; (3) an initiative for transplant recipients and living donors to share stories and experiences; and (4) program-level performance reports and oversight by administrative leaders.
MAIN OUTCOMES AND MEASURES:
The primary outcome was the rate of steps completed toward receiving a kidney transplant. Each patient could complete up to 4 steps: step 1, referred to a transplant center for evaluation; step 2, had a potential living donor contact a transplant center for evaluation; step 3, added to the deceased donor waitlist; and step 4, received a transplant from a living or deceased donor.
RESULTS:
The 26 CKD programs (13 intervention, 13 usual care) during the trial period included 20 375 potentially transplant-eligible patients with advanced CKD (intervention group [n = 9780 patients], usual-care group [n = 10 595 patients]). Despite evidence of intervention uptake, the step completion rate did not significantly differ between the intervention vs usual-care groups: 5334 vs 5638 steps; 24.8 vs 24.1 steps per 100 patient-years; adjusted hazard ratio, 1.00 (95% CI, 0.87-1.15).
CONCLUSIONS AND RELEVANCE:
This novel multicomponent intervention did not significantly increase the rate of completed steps toward receiving a kidney transplant. Improving access to transplantation remains a global priority that requires substantial effort.
Mr John O'Callaghan, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion:
This is a small study, albeit randomised. Only 5 patients received the alkaline phosphatase treatment and 6 placebo. Given the prior successful use of alkaline phosphatase in cardiac surgery patients could it not have been used in a larger study here, and therefore have more potential to identify any beneficial impact? The study was also conducted only in live kidney transplantation and therefore the potential impact on any ischeamia-reperfusion injury was relatively minimal. Donation after cardiac death is where any potential benefit lies. As it stands, the study showed no real difference between placebo and alkaline phosphatase. The study drug was safely administered in this small group of recipients.
Aims:
The aim of this study was to assess the feasibility and safety of alkaline phosphatase for treating ischaemia–reperfusion injury in living donor kidney transplantation.
Interventions:
Participants were randomised to either the alkaline phosphatase (bRESCAP) group or the placebo group.
Participants:
11 living donor kiney transplant recipients.
Outcomes:
The primary endpoint was 1-year graft function. The secondary endpoints included (serious) AEs (SAEs), and urine and serum biomarkers.
Follow Up:
1 year posttransplantation
AIMS:
Ischemia-reperfusion injury (IRI) during kidney transplant procedures is associated with adverse outcome. Alkaline phosphatase (AP) is an enzyme that has the potential to dampen IRI. Prior to this study, it had not been tested in the setting of kidney transplantation. This study aimed to evaluate the safety and feasibility of peri-procedural AP administration in living donor kidney transplantation.
METHODS:
In this double blind, randomized, placebo-controlled, single-center pilot study, all eligible recipients of living donor kidneys were asked to give informed consent. AP (bRESCAP) or a placebo was administered intravenously over 24 hours after the transplantation procedure. The primary outcome-graft function at 1 year-was represented by iohexol measured glomerular filtration rate (mGFR). Serum and urine biomarkers within seven days after surgery were used as surrogate markers of kidney function and injury.
RESULTS:
Eleven patients were enrolled of whom five were treated with bRESCAP and six with placebo. After 1 year, mGFR was not different between groups. No specific adverse events were observed in the bRESCAP group. Urine expression of injury biomarkers CCL14, NGAL and Cystatin C was lower in the bRESCAP group at day seven. This was statistically significant.
CONCLUSION:
This study illustrates that bRESCAP treatment is feasible in kidney transplantation, might have a dampening effect on IRI induced renal inflammation, and raises no safety concerns. Future research will evaluate the effects of bRESCAP treatment in donation after circulatory death kidney transplantation where IRI is more pronounced.
Mr John O'Callaghan, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion:
This is an interesting, well-conducted, and well-written, systematic review in living donation that gives a good description of the complexity in the donor-recipient relationship and the psychological outcome for the donor. Two independent reviewers screened references, extracted data and performed the risk-of bias assessment, which is clearly presented. A broad search was done, albeit only within pubmed/medline. 23 studies were included, comprised of a total 2,732 donors. The authors give a detailed description of the studies in narrative review. There is quantitative evidence from 3 studies that quality of life is the same pre and post-donation, whilst another 4 studies found quantitative evidence of improved quality of life at 1 year post-donation. These studies indicate risk factors that may be predictive of decreased donor quality of life such as donor fatigue, anxiety, depression, lack of social support, the donor-recipient relationship and any complications for the recipient. Three studies found no evidence of an impact of socio-economic status on quality-of-life post-donation. In general, studies found that the relationship between donors and recipients remained unchanged or improved/became closer. Some donors expected that their role as a carer for the recipient would decrease after donation. If this did not happen, donors felt disappointed or frustrated. In the majority of cases, donors were satisfied and did not regret donation. Importantly it was clearly demonstrated that it was possible to regret donation oneself, but to still recommend it for others. All studies showed a low rate of regret. There was some evidence of correlation between regret and the recipient’s outcome from the transplant, but evidence was conflicting. One interesting complexity highlighted by the study is that donors used conscious or unconscious strategies to influence the transplant team to select them as a donor. This may make it difficult to interpret the results of pre and post-donation comparisons. The authors also acknowledge the impact of social desirability bias, which may have affected donor responses to questionnaires.
Aims:
This study aimed to examine the psychological effects of donating a kidney on living donors.
Interventions:
A literature search was performed using Pubmed and Medline. Study screening and data extraction were performed by two independent reviewers. The ROBINS-I tool was used to assess the risk of bias.
Participants:
23 studies were included in the review.
Outcomes:
The main outcomes of interest included assessment of quality of life, anxiety/ depression, regret of donation, psychological impact over failure of transplant/death, and consequence of donation on donor/recipient relationship.
Follow Up:
N/A
We performed a systematic literature review of the psychological impact on donors of living kidney donation. We conducted a literature review in PubMed/Medline according to PRISMA guidelines which included both qualitative (based on interviews) and quantitative studies (based on standardized questionnaire). There were 15 quantitative studies and 8 qualitative studies with 2,732 donors. Given that the methodologies of qualitative and quantitative studies are fundamentally different, we narratively synthetized results of studies according to four axes: quality of life, anxiety/depression, consequences of donation on the donor/recipient relationship, overall satisfaction and regret. The quantitative studies reported that donor quality of life remained unchanged or improved. Donor regret rates were very low and donor-recipient relationships also remained unchanged or improved. Qualitative studies reported more complex donation experiences: one can regret donation and still decide to recommend it as in a social desirability bias. In both study types, donor-recipient relationships were closer but qualitative studies reported that post-donation rebonding was required. The qualitative studies therefore highlighted the psychological complexity of donation for donors, showing that living donation impacts the donor's life whether it is successful or not. A better understanding of the impact of donation on donors could provide better care for donors.
Mr John O'Callaghan, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion:
This paper details the protocol for a very interesting study in live kidney donation. Potential kidney transplant recipients will be randomised into four groups: 1) No intervention, 2) search intervention- advising patients on which social network members are most likely to be contraindication free, 3) script intervention- advises patients on how to initiate effective live kidney donor discussions, 4) both search and script interventions. The primary outcome is the receipt of a live kidney transplant. This study will be conducted in the USA, where there are currently large discrepancies in live donation rates between ethnic groups. The supplemental material online gives an excellent background to the study and thorough explanation of the rationale.
Aims:
This protocol aims to provide the rationale behind the design of the Friends and Family of Kidney Transplant Patients Study (FFKTPS) and the planned analyses to test the efficacy of these interventions.
Interventions:
Participants will be randomly assigned into four groups: no intervention, search only, script only, or both search and script.
Participants:
Kidney transplant candidates.
Outcomes:
The primary endpoint is living donor kidney transplantation (LDKT) recipient. The secondary endpoints are live kidney donor (LKD) screening and medical evaluations and outcomes.
Follow Up:
36 months
INTRODUCTION:
Racial/ethnic disparities in living donor kidney transplantation (LDKT) are a persistent challenge. Although nearly all directed donations are from members of patients' social networks, little is known about which social network members take steps toward living kidney donation, which do not, and what mechanisms contribute to racial/ethnic LDKT disparities.
METHODS:
We describe the design and rationale of the Friends and Family of Kidney Transplant Patients Study, a factorial experimental fielding two interventions designed to promote LKD discussions. Participants are kidney transplant candidates at two centers who are interviewed and delivered an intervention by trained center research coordinators. The search intervention advises patients on which social network members are most likely to be LKD contraindication-free; the script intervention advises patients on how to initiate effective LKD discussions. Participants are randomized into four conditions: no intervention, search only, script only, or both search and script. Patients also complete a survey and optionally provide social network member contact information so they can be surveyed directly. This study will seek to enroll 200 transplant candidates. The primary outcome is LDKT receipt. Secondary outcomes include live donor screening and medical evaluations and outcomes. Tertiary outcomes include LDKT self-efficacy, concerns, knowledge, and willingness, measured before and after the interventions.
CONCLUSION:
This study will assess the effectiveness of two interventions to promote LKD and ameliorate Black-White disparities. It will also collect unprecedented information on transplant candidates' social network members, enabling future work to address network member structural barriers to LKD.
Mr Simon Knight, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion:
This systematic review explores the published data regarding living kidney donors with a history of renal stones. The authors identified 14 studies of 432 patients, identifying just one patient with a reported stone-related event. However, the identified studies were limited in quality and detail, and the average follow-up was just 21.1 months. Review methodology is good, with protocol registration, thorough literature search strategies and quality assessment. The authors make the best of the literature available with a comprehensive and well-written summary, but as they point out, there is significant risk of publication bias and under-reporting. More robust long-term registry data is required to truly quantify the risk to donors with existing stone disease.
Aims:
This study aimed to investigate the outcomes of kidney donors with a prior history of nephrolithiasis following donation.
Interventions:
A literature search was conducted on Ovid and Embase. Eligible studies were selected by two independent reviewers. The Newcastle-Ottawa scale was used to assess the quality of the included studies.
Participants:
14 studies were included the review.
Outcomes:
The primary outcome was stone-related event including stone-formation following donation, stone-induced obstruction, acute renal failure and sepsis. The secondary outcomes included short-term (≤30 days) and long-term (≥12 months) renal function.
Follow Up:
N/A
The clinical outcomes of kidney donors with a prior history of nephrolithiasis are poorly defined. We conducted a systematic review assessing the post-donation clinical outcomes of kidney donors with a history of nephrolithiasis. Electronic databases (Ovid and Embase) were searched between 1960 and 2021 using key terms and Medical Subject Headings (MeSH) - nephrolithiasis, renal stones, renal transplantation and renal graft. Articles included conference proceedings and journal articles and were not excluded based on patient numbers. Primary outcome was donor stone-related event. Secondary outcomes were renal function upon follow-up or post-operative nephrectomy complications. In summary, 340 articles were identified through database search. We identified 14 studies (16 cohorts) comprising 432 live donors followed up for a median of 26 months post live kidney donation. Six donors donated the stone-free kidney whilst 23 live donors had bilateral stones. Mean stone size was 4.2 ± 1.4 mm (1-16) with average follow up duration of 21.1 months (1-149). Twelve studies provided primary outcome (n = 138 patients) and eight (n = 348) for secondary outcomes. One donor had a stone-related event upon follow up. A total of 195 patients had eGFR <60 upon follow up. However, they were not significantly different when compared to renal function of live donors that didn't have pre-donation nephrolithiasis. Many of the studies couldn't provide long term follow up, coupled with limited data regarding the nature of the pre-donation stone disease. In conclusion, this systematic review shows that we have very limited information upon which to base recommendation regarding pre-donation risk of post-donation complications. Longer term follow up is required and lifelong follow up with live donor registries will aid further understanding.
Reshma Rana Magar, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion:
This study aimed to establish whether factors such as anticipated regret, the deceased wishes and next-of-kin attitudes could predict next-of-kin approval for organ donation, and to develop a model of next-of-kin decision making regarding organ donation in Wales, UK, which has an opt-out system. A total of 808 participants were randomly assigned to imagine whether a deceased relative had either opted-in, opted-out or had not registered a decision (deemed consent). The authors concluded that anticipated regret significantly influenced the next-of-kin approval for organ donation, and also that if the next-of kin had negative beliefs towards organ donation, they were less likely to follow the deceased wishes to donate. It is possible that the participants may have underestimated the influence of their emotions on future decision-making process; thus, how they believed they would act may be different from how they behave in real life. The authors do a good job of acknowledging this. However, the study did not assess ethnicity or religion, both of which have been found to affect the decision of the next-of-kin on organ donation. These could have acted as potential confounders in the analyses. Perhaps another factor the authors could have also considered is the type of relationship between the deceased donor and the next-of-kin. It would have been interesting to see if relatives with negative attitude towards organ donation were able to override their beliefs and follow the deceased donor’s wishes to donate if the deceased donor was an authority figure or a final decision maker when alive. For example, in cultures where fathers are the main decision makers, there may be a higher chance of sons/daughters respecting their deceased father’s wishes to donate despite their negative affective attitudes, in comparison to fathers respecting their deceased children’s wishes.
Aims:
This study aimed to investigate how the deceased donor’s wishes, negative affective attitudes, perceived benefits and anticipated regret had an effect on the next-of-kin’s approval of organ donation under opt-out legislation.
Interventions:
Participants were randomised to imagine if their deceased relative had either opted in, opted-out or not registered a decision (deemed consent).
Participants:
Adults (≥18 years) living in Wales.
Outcomes:
The outcome variables of interest included previous health-based philanthropy, uncertainty, anticipated regret, intention of next-of-kin to approve donation of organs, negative affective attitudes and perceived benefits.
Follow Up:
Not reported
RATIONALE:
Family, and sometimes longstanding friends, have considerable influence over organ donation, through agreeing or disagreeing to the donation of a deceased individual's organs. To date, most research has been undertaken within opt-in systems.
OBJECTIVE:
This study advances on previous research by assessing next-of-kin approval under opt-out legislation. We tested whether next-of-kin approval varies when the deceased is a registered donor (opted-in), registered non-donor (opted-out) or has not registered a decision under an opt-out policy (deemed consent). We also tested if the deceased's wishes influenced next-of-kin approval through relatives anticipating regret for not donating and feelings of uncertainty. Finally, we assessed whether next-of-kin's own beliefs about organ donation influenced whether they followed the deceased's wishes.
METHODS:
Participants (N = 848) living in a country with opt-out legislation (Wales, UK) were asked to imagine a relative had died under an opt-out system and decided if their relatives' organs should be donated. Participants were randomly allocated to imagine the deceased had either (i) opted-in, (ii) opted-out or (iii) not registered a decision (deemed consent). The outcome variable was next-of-kin approval, with uncertainty and anticipated regret as potential mediators and next-of-kin's beliefs about organ donation as moderators.
RESULTS:
Next-of-kin approval was lower when the deceased had opted-out than under deemed consent. This was due to next-of-kin anticipating more regret for not donating under deemed consent than opt-out. Further analyses revealed the deceased's wishes influence next-of-kin approval, via anticipated regret, when next-of-kin did not hold negative beliefs about organ donation.
CONCLUSIONS:
The deceased's wishes were less likely to be followed when next-of-kin had negative beliefs towards donation. Developing large-scale campaigns to improve these beliefs in the general public should make people more likely to follow the deceased's wishes. As a result, these campaigns should improve the availability of donor organs.
Mr John O'Callaghan, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion:
This paper is the protocol for the statistical analysis plan for a randomised trial. The trial is an ambitious one across 26 centres in Canada, and including over 10,000 patients. The study will hopefully provide reliable results through several features described in this detailed statistical analysis plan. The primary outcome is the number of completed steps towards receiving a kidney transplant. 10 pre-specified subgroup analyses are described.
Aims:
This protocol for a cluster-randomised trial aims to examine the effect of the Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) quality improvement intervention on completing key steps toward receiving a renal transplant.
Interventions:
Participants will be randomised to either the EnAKT LKD intervention group or the usual care group.
Participants:
Adult patients with advanced chronic kidney disease (CKD).
Outcomes:
The main outcome of interest includes completed steps toward receiving a kidney transplant, which involves four unique steps per patient: (1) patient referral to a transplant center for evaluation (2) evalulation of a potential living kidney donor begins at a transplant center to donate a kidney to the patient, (3) inclusion of the patient to the deceased donor transplant waitlist, and (4) a living or deceased donor kidney transplant is received by the patient.
Follow Up:
N/A
BACKGROUND:
Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) is a quality improvement intervention designed to enhance access to kidney transplantation and living kidney donation. We conducted a cluster-randomized clinical trial to evaluate the effect of the intervention versus usual care on completing key steps toward receiving a kidney transplant.
OBJECTIVE:
To prespecify the statistical analysis plan for the EnAKT LKD trial.
DESIGN:
The EnAKT LKD trial is a pragmatic, 2-arm, parallel-group, registry-based, open-label, cluster-randomized, superiority, clinical trial. Randomization was performed at the level of the chronic kidney disease (CKD) programs (the "clusters").
SETTING:
Twenty-six CKD programs in Ontario, Canada.
PARTICIPANTS:
More than 10 000 patients with advanced CKD (ie, patients approaching the need for dialysis or receiving maintenance dialysis) with no recorded contraindication to receiving a kidney transplant.
METHODS:
The trial data (including patient characteristics and outcomes) will be obtained from linked administrative health care databases (the "registry"). Stratified covariate-constrained randomization was used to allocate the 26 CKD programs (1:1) to provide the intervention or usual care from November 1, 2017, to December 31, 2021 (4.17 years). CKD programs in the intervention arm received the following: (1) support for local quality improvement teams and administrative needs; (2) tailored education and resources for staff, patients, and living kidney donor candidates; (3) support from kidney transplant recipients and living kidney donors; and (4) program-level performance reports and oversight by program leaders.
OUTCOMES:
The primary outcome is completing key steps toward receiving a kidney transplant, where up to 4 unique steps per patient will be considered: (1) patient referred to a transplant center for evaluation, (2) a potential living kidney donor begins their evaluation at a transplant center to donate a kidney to the patient, (3) patient added to the deceased donor transplant waitlist, and (4) patient receives a kidney transplant from a living or deceased donor.
ANALYSIS PLAN:
Using an intent-to-treat approach, the primary outcome will be analyzed using a patient-level constrained multistate model adjusting for the clustering in CKD programs.
TRIAL STATUS:
The EnAKT LKD trial period is November 1, 2017, to December 31, 2021. We expect to analyze and report the results once the data for the trial period is available in linked administrative health care databases.
TRIAL REGISTRATION:
The EnAKT LKD trial is registered with the U.S. National Institute of Health at clincaltrials.gov (NCT03329521 available at https://clinicaltrials.gov/ct2/show/NCT03329521).
Mr Simon Knight, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion:
This systematic review summarises the literature and guidelines relating to pregnancy following living kidney donation. The authors identified 16 studies reporting on 1399 post-donation pregnancies. Whilst the risk of pre-eclampsia increased post-donation, it is in keeping with an unselected general population. No difference was found in risk of other pregnancy or foetal complications. Guidelines were found to be generally consistent in advice. Methodology appears good, with well-described searches across a number of databases and screening by 3 reviewers. Risk of bias was assessed with the Robins-I tool and found to be low-moderate in most studies. Of note, studies were published over a long period (35 years) so it is perhaps not clear how relevant results of early studies are to today’s practice. Overall, the authors graded the certainty of evidence in risk of hypertension and pre-eclampsia as “low” and for other foetal outcomes as “very low”, reflecting the quality and size of the underlying evidence. This paper provides a very good summary of the evidence (and limitations thereof) regarding post-donation pregnancy.
Aims:
The aim of this study was to identify all available evidence investigating pregnancy complications post-living kidney donation, and to compare the quality and consistency of guidelines focusing on pregnancy in living kidney donors.
Interventions:
A literature search was conducted on Embase, PubMed, MEDLINE, society webpages and guideline registries. Three independent reviewers performed the initial screening of study titles and abstracts. Eligibility assessment of full-text articles and data extraction were carried out by two independent reviewers. The methodological quality of the included studies were assessed using the Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I) tool.
Participants:
16 studies were included in the review.
Outcomes:
The main outcomes of interest were post-donation pregnancy complications, and the risk of adverse maternal, fetal and neonatal outcomes.
Follow Up:
N/A
Understanding and communicating the risk of pregnancy complications post-living kidney donation is imperative as the majority of living kidney donors (LKD) are women of childbearing age. We aimed to identify all original research articles examining complications in post-donation pregnancies and compared the quality and consistency of related guidelines. We searched Embase, MEDLINE, PubMed, society webpages, and guideline registries for English-language publications published up until December 18, 2020. Ninety-three articles were screened from which 16 studies were identified, with a total of 1399 post-donation pregnancies. The outcome of interest, post-donation pregnancy complications, was not calculable, and only a narrative synthesis of the evidence was possible. The absolute risk of pre-eclampsia increased from ~1%-3% pre-donation (lower than the general population) to ~4%-10% post-donation (comparable to the general population). The risks of adverse fetal and neonatal outcomes were no different between post-donation and pre-donation pregnancies. Guidelines and consensus statements were consistent in stating the need to inform LKDs of their post-donation pregnancy risk, however, the depth and scope of this guidance were variable. While the absolute risk of pregnancy complications remains low post-donation, a concerted effort is required to better identify and individualize risk in these women, such that consent to donation is truly informed.
Mr Simon Knight, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion:
This systematic review and meta-analysis aimed to investigate the impact of donor age, sex, body mass index and ethnicity on the outcome for living kidney donors. Analysis of data from 31 observational studies demonstrated inferior outcomes in male donors, and those with a BMI greater than 30 kg/m2. African donors were found to be more likely to develop renal failure in the long-term than younger donors. Whilst some of the findings are perhaps not too surprising (reflecting the same outcomes in the general population), these data do help in the personalisation of risk assessment for donors and highlight the importance of robust follow-up for higher risk groups. It should be noted that the nature of the review question means that only observational data can be used, most of which is retrospective in nature and prone to high heterogeneity. Nonetheless, this represents a large analysis of the body of published literature on this topic.
Aims:
This study aimed to investigate the effect of age, sex, body mass index (BMI) and ethnicity on short and long term outcomes for living kidney donors.
Interventions:
Electronic databases including Cochrane, Ovid, and Web of Science were searched. Study screening and data extraction were performed by two independent reviewers. The National Heart, Lung, and Blood Institute quality assessment tool was used to assess the methodological quality of the included studies.
Participants:
31 studies were included in the review.
Outcomes:
The primary outcome was the effect of donor demographics (ethnicity, BMI, age, and sex) on kidney function. The secondary outcomes included the effect of donor demographics on the incidence of end-stage renal disease (ESRD), serum creatinine level, donor survival, incidence of proteinuria, blood pressure (BP), de novo hypertension, and surgical complications.
Follow Up:
N/A
BACKGROUND:
Living kidney donation risk is likely to differ according to donor's demographics. We aimed to analyse the effects of age, sex, body mass index (BMI) and ethnicity.
METHODS:
A systematic review and meta-analysis was undertaken of the effects of preoperative patient characteristics on donor kidney function outcomes, surgical complications, and hypertension.
RESULTS:
5129 studies were identified, of which 31 met the inclusion criteria, mainly from the USA and Europe. The estimated glomerular filtration rate (eGFR) in donors aged over 60 years was a mean of 9.54 ml per min per 1.73 m2 lower than that of younger donors (P < 0.001). Female donors had higher relative short- and long-term survival. BMI of over 30 kg/m2 was found to significantly lower the donor's eGFR 1 year after donation: the eGFR of obese donors was lower than that of non-obese patients by a mean of -2.70 (95 per cent c.i. -3.24 to -2.15) ml per min per 1.73 m2 (P < 0.001). Obesity was also associated with higher blood pressure both before and 1 year after donation, and a higher level of proteinuria, but had no impact on operative complications. In the long term, African donors were more likely to develop end-stage renal disease than Caucasians.
CONCLUSION:
Obesity and male sex were associated with inferior outcomes. Older donors (aged over 60 years) have a larger eGFR decline than younger donors, and African donors have a higher incidence of ESRD than Caucasians.
Dr Liset Pengel, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion:
The systematic review and meta-analysis summarised the evidence regarding the risk of pregnancy related complications in kidney donors versus non-donors. A comprehensive literature search was conducted and comparative, prospective or retrospective studies were selected by independent reviewers. Data extraction and risk of bias assessment were also completed by independent reviewers. GRADE was used to assess the quality of the evidence. Five studies met the inclusion criteria, reporting on 430 donors and 23,540 non-donors. The risk of bias of the included studies was rated as low to moderate. Pooled analyses showed that kidney donation was associated with an increased risk of preeclampsia (5 studies, moderate quality evidence), gestational hypertension (5 studies, low quality evidence) and preterm birth (4 studies, moderate quality evidence). Heterogeneity ranged from low to substantial and was not explored further. There were no differences in risks between donor and non-donors for gestational diabetes, caesarean delivery, low birthweight and fetal death (all outcomes were rated as low quality evidence). The systematic review provides limited evidence of some risks of pregnancy related complications in kidney donors.
Aims:
Electronic databases including Scopus, Medline, CENTRAL, Web of Science and Google Scholar were searched. Study selection and data extraction were carried out by two independent reviewers. The methodological quality of the included studies was assessed using the the ROBINS-I (Risk Of Bias In Non-randomized Studies-of Interventions) tool.
Interventions:
5 studies were included in the review.
Participants:
Adverse pregnancy outcomes.
Outcomes:
The systematic review and meta-analysis summarised the evidence regarding the risk of pregnancy related complications in kidney donors versus non-donors. A comprehensive literature search was conducted and comparative, prospective or retrospective studies were selected by independent reviewers. Data extraction and risk of bias assessment were also completed by independent reviewers. GRADE was used to assess the quality of the evidence. Five studies met the inclusion criteria, reporting on 430 donors and 23,540 non-donors. The risk of bias of the included studies was rated as low to moderate. P
Follow Up:
N/A
Living kidney donation is associated with glomerular hyperfiltration, predisposing for the development of chronic kidney disease. The present meta-analysis aims to gather current evidence and clarify whether kidney donors are at increased risk of future pregnancy complications. Medline, Scopus, Web of Science, CENTRAL and Google Scholar were systematically searched from inception to August 29, 2021. Observational studies comparing the rates of adverse pregnancy outcomes among kidney donors and non-donors were selected. Random-effects models were fitted to provide meta-analysis estimates, while the quality of evidence was appraised with the Grading of Recommendations Assessment, Development and Evaluation approach. Five studies were included, comprising 430 donors and 23,540 non-donors. Living kidney donation was associated with significantly higher risk of preeclampsia (OR: 2.86, 95% CI: 1.62-5.05, moderate quality of evidence), gestational hypertension (OR: 2.53, 95% CI: 1.11-5.74, low quality of evidence) and preterm birth (OR: 1.32, 95% CI: 1.01-1.74, moderate quality of evidence). The anticipated absolute rates of preeclampsia, gestational hypertension and preterm birth were 7.4%, 5.4% and 8.3%, respectively. The risk of gestational diabetes, cesarean delivery, low birthweight and fetal death was similar between the two groups (low quality of evidence). In conclusion, women with history of kidney donation are at significantly increased risk of preeclampsia, gestational hypertension and preterm birth in subsequent pregnancies, although the absolute rate of complications remains below 10%. Future studies should confirm these effects and improve potential donor counseling by individualizing the risk of adverse perinatal outcomes.
CET Conclusion