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1.
JAMA ; 2024 May 23.
Article En | MEDLINE | ID: mdl-38780499

Importance: Recent guidelines call for better evidence on health outcomes after living kidney donation. Objective: To determine the risk of hypertension in normotensive adults who donated a kidney compared with nondonors of similar baseline health. Their rates of estimated glomerular filtration rate (eGFR) decline and risk of albuminuria were also compared. Design, Setting, and Participants: Prospective cohort study of 924 standard-criteria living kidney donors enrolled before surgery and a concurrent sample of 396 nondonors. Recruitment occurred from 2004 to 2014 from 17 transplant centers (12 in Canada and 5 in Australia); follow-up occurred until November 2021. Donors and nondonors had the same annual schedule of follow-up assessments. Inverse probability of treatment weighting on a propensity score was used to balance donors and nondonors on baseline characteristics. Exposure: Living kidney donation. Main Outcomes and Measures: Hypertension (systolic blood pressure [SBP] ≥140 mm Hg, diastolic blood pressure [DBP] ≥90 mm Hg, or antihypertensive medication), annualized change in eGFR (starting 12 months after donation/simulated donation date in nondonors), and albuminuria (albumin to creatinine ratio ≥3 mg/mmol [≥30 mg/g]). Results: Among the 924 donors, 66% were female; they had a mean age of 47 years and a mean eGFR of 100 mL/min/1.73 m2. Donors were more likely than nondonors to have a family history of kidney failure (464/922 [50%] vs 89/394 [23%], respectively). After statistical weighting, the sample of nondonors increased to 928 and baseline characteristics were similar between the 2 groups. During a median follow-up of 7.3 years (IQR, 6.0-9.0), in weighted analysis, hypertension occurred in 161 of 924 donors (17%) and 158 of 928 nondonors (17%) (weighted hazard ratio, 1.11 [95% CI, 0.75-1.66]). The longitudinal change in mean blood pressure was similar in donors and nondonors. After the initial drop in donors' eGFR after nephrectomy (mean, 32 mL/min/1.73 m2), donors had a 1.4-mL/min/1.73 m2 (95% CI, 1.2-1.5) per year lesser decline in eGFR than nondonors. However, more donors than nondonors had an eGFR between 30 and 60 mL/min/1.73 m2 at least once in follow-up (438/924 [47%] vs 49/928 [5%]). Albuminuria occurred in 132 of 905 donors (15%) and 95 of 904 nondonors (11%) (weighted hazard ratio, 1.46 [95% CI, 0.97-2.21]); the weighted between-group difference in the albumin to creatinine ratio was 1.02 (95% CI, 0.88-1.19). Conclusions and Relevance: In this cohort study of living kidney donors and nondonors with the same follow-up schedule, the risks of hypertension and albuminuria were not significantly different. After the initial drop in eGFR from nephrectomy, donors had a slower mean rate of eGFR decline than nondonors but were more likely to have an eGFR between 30 and 60 mL/min/1.73 m2 at least once in follow-up. Trial Registration: ClinicalTrials.gov Identifier: NCT00936078.

2.
Transl Behav Med ; 14(6): 319-329, 2024 May 24.
Article En | MEDLINE | ID: mdl-38642402

The "Food as Medicine" (FAM) movement encourages public health and medical professionals to recognize the importance of dietary patterns and food access. The purpose of this work was to describe patient and physician engagement with a produce prescription (PRx) program to improve access to fresh vegetables in a healthcare setting. A Federally Qualified Health Center, regenerative farm, and academic institution partnered for the PRx program (2017-21). During harvest seasons, patients redeemed "prescriptions" for initial and "refill" produce boxes. Baseline food insecurity surveys were embedded in electronic medical records. Refill surveys assessed satisfaction and confidence. Electronic surveys to prescribing physicians assessed program knowledge, expectations, and motivations. Across 8 biannual harvests generating 9986 produce boxes, 8046 patients received prescriptions, 6227 redeemed prescriptions for ≥1 box, and 720 redeemed for ≥2 boxes. Seasonally, initial redemption rates ranged from 64.5% to 82.7%; refill rates ranged from 6.8% to 16.7%. Among participants, 70.8% sometimes/often worried food would run out and 66.7% sometimes/often ran out of food. Among those with refills, there was high satisfaction with food quality (95.8%) and variety (97.2%), and 94.2% were confident preparing meals from produce. Among physicians (n = 22), 100% self-reported adequate knowledge about PRx for patient recommendations, and 100% believed PRx had benefit for patients. Chronic conditions (77%), low socioeconomic status (64%), and food insecurity (59%) were common motivating factors for prescriptions. We demonstrated the feasibility of implementing a cross-sector, seasonal PRx program within a multisite healthcare system. More research is needed to refine implementation toward greater patient refill rates.


Food is an important aspect of health, and people with limited access to food face more barriers to health. Healthcare settings are places where patients can get encouragement about nutrition goals and obtain food. In this study, patients at a large healthcare center received "prescriptions" for boxes of fresh vegetables, which were stored on-site and given to patients free of charge. Patients and doctors were asked to complete surveys to give their feedback on the program. The program lasted for 5 years, and during that time nearly 10 000 produce prescription boxes were given to over 6000 patients. Many of these patients did not have consistent access to food before this program. Overall, patients who received more than two boxes of fresh vegetables were satisfied with the vegetables they received, and doctors who completed the program survey believed that this program was important for patients. Food programs in healthcare settings may help patients access food, but more work is needed to refine the program.


Vegetables , Humans , Male , Female , Adult , Middle Aged , Food Insecurity , Program Evaluation , Prescriptions , Aged , Young Adult , Food Supply
3.
Front Genet ; 15: 1383220, 2024.
Article En | MEDLINE | ID: mdl-38638120

The optimal immunosuppression management in patients with a failed kidney transplant remains uncertain. This study analyzed the association of class II HLA eplet mismatches and maintenance immunosuppression with allosensitization after graft failure in a well characterized cohort of 21 patients who failed a first kidney transplant. A clinically meaningful increase in cPRA in this study was defined as the cPRA that resulted in 50% reduction in the compatible donor pool measured from the time of transplant failure until the time of repeat transplantation, death, or end of study. The median cPRA at the time of failure was 12.13% (interquartile ranges = 0.00%, 83.72%) which increased to 62.76% (IQR = 4.34%, 99.18%) during the median follow-up of 27 (IQR = 18, 39) months. High HLA-DQ eplet mismatches were significantly associated with an increased risk of developing a clinically meaningful increase in cPRA (p = 0.02) and de novo DQ donor-specific antibody against the failed allograft (p = 0.02). We did not observe these associations in patients with high HLA-DR eplet mismatches. Most of the patients (88%) with a clinically meaningful increase in cPRA had both a high DQ eplet mismatch and a reduction in their immunosuppression, suggesting the association is modified by immunosuppression. The findings suggest HLA-DQ eplet mismatch analysis may serve as a useful tool to guide future clinical studies and trials which assess the management of immunosuppression in transplant failure patients who are repeat transplant candidates.

4.
Kidney Med ; 6(5): 100812, 2024 May.
Article En | MEDLINE | ID: mdl-38665993

Rationale & Objective: A high level of cooperation between organ procurement organizations and transplant programs may help maximize use of deceased donor kidneys. The practices that are essential for a high functioning organ donation and transplant system remain uncertain. We sought to report metrics of organ donation and transplant performance in British Columbia, Canada, and to assess the association of specific policies and practices that contribute to the system's performance. Study Design: A retrospective observational study. Setting & Participants: Referred deceased organ donors in British Columbia were used in the study from January 1, 2016, to December 31 2019. Exposures: Provincial, organ procurement organization, and center level policies were implemented to improve donor referral and organ utilization. Outcomes: Assessment of donor and kidney utilization along steps of the critical pathway for organ donation. Analytical Approach: Deceased donors were classified according to the critical pathway for organ donation and key donation and transplant metrics were identified. Results: There were 1,948 possible donors referred. Of 1,948, 754 (39%) were potential donors. Of 754 potential donors, 587 (78%) were consented donors. Of 587 consented donors, 480 (82%) were eligible kidney donors. Of 480 eligible kidney donors, 438 (91%) were actual kidney donors. And of 438 actual kidney donors, 432 (99%) were utilized kidney donors. One-year all-cause allograft survival was 95%. Practices implemented to improve the system's performance included hospital donor coordinators, early communication between the organ procurement organization and transplant nephrologists, dedicated organ recovery and implant surgeons, aged-based kidney allocation, and hospital admission of recipients before kidney recovery. Limitations: Assignment of causality between individual policies and practices and organ donation and utilization is limited in this observational study. Conclusions: In British Columbia, consent for donation, utilization of donated kidneys, and transplant survival are exceptionally high, suggesting the importance of an integrated deceased donor and kidney transplant service.


Optimization of all possible opportunities for deceased donor kidney donation and transplantation is essential to meet the need for transplantation. We examined the performance of organ procurement and transplant in a deceased organ donor system in British Columbia, Canada, and reviewed policies and practices that may contribute to the system's performance. We found a high level of donation, transplantation, and survival of donated kidneys and identified policies and practices that likely contribute to the system's performance.

5.
Am J Kidney Dis ; 2024 Mar 05.
Article En | MEDLINE | ID: mdl-38452918

Chronic kidney disease affects an estimated 37 million people in the United States; of these,>800,000 have end-stage renal disease requiring chronic dialysis or a kidney transplant to survive. Despite efforts to increase the donor kidney supply, approximately 100,000 people are registered on the kidney transplant wait-list with no measurable decrease over the past 2 decades. The outcomes of kidney transplantation are significantly better than for chronic dialysis: kidney transplant recipients have lower rates of mortality and cardiovascular events and better quality of life, but wait-list time matters. Time on dialysis waiting for a deceased-donor kidney is a strong independent risk factor for outcomes after a kidney transplant. Deceased-donor recipients with wait-list times on dialysis of<6 months have graft survival rates equivalent to living-donor recipients with waitlist times on dialysis of>2 years. In 2021,>12,000 people had been on the kidney transplant waitlist for ≥5 years. As the gap between the demand for and availability of donor kidneys for allotransplantation continues to widen, alternative strategies are needed to provide a stable, sufficient, and timely supply. A strategy that is gaining momentum toward clinical application is pig-to-human kidney xenotransplantation. This report summarizes the proceedings of a meeting convened on April 11-12, 2022, by the National Kidney Foundation to review and assess the state of pig-to-human kidney xenotransplantation as a potential cure for end-stage renal disease.

6.
Nat Commun ; 15(1): 554, 2024 Jan 16.
Article En | MEDLINE | ID: mdl-38228634

In kidney transplantation, day-zero biopsies are used to assess organ quality and discriminate between donor-inherited lesions and those acquired post-transplantation. However, many centers do not perform such biopsies since they are invasive, costly and may delay the transplant procedure. We aim to generate a non-invasive virtual biopsy system using routinely collected donor parameters. Using 14,032 day-zero kidney biopsies from 17 international centers, we develop a virtual biopsy system. 11 basic donor parameters are used to predict four Banff kidney lesions: arteriosclerosis, arteriolar hyalinosis, interstitial fibrosis and tubular atrophy, and the percentage of renal sclerotic glomeruli. Six machine learning models are aggregated into an ensemble model. The virtual biopsy system shows good performance in the internal and external validation sets. We confirm the generalizability of the system in various scenarios. This system could assist physicians in assessing organ quality, optimizing allograft allocation together with discriminating between donor derived and acquired lesions post-transplantation.


Kidney Diseases , Kidney Transplantation , Humans , Kidney/pathology , Transplantation, Homologous , Kidney Diseases/pathology , Biopsy
8.
Kidney Int ; 105(3): 470-472, 2024 Mar.
Article En | MEDLINE | ID: mdl-37914085

Declining rates of peritransplant cardiovascular death, an increasing burden of pretransplant tests, and concerns about the effectiveness of screening candidates for coronary artery disease have led many transplant programs to de-escalate screening protocols. Recent Kidney Disease: Improving Global Outcomes and American Heart Association scientific statements and guidelines neatly summarize current evidence, but also identify areas of need. Here, we argue that key questions should be addressed by adequately powered clinical trials before our long-held screening paradigms are completely rewritten.


Coronary Artery Disease , Kidney Diseases , Kidney Failure, Chronic , Kidney Transplantation , Humans , Coronary Artery Disease/diagnosis , Coronary Artery Disease/therapy , Kidney Transplantation/methods
10.
Kidney Med ; 5(8): 100684, 2023 Aug.
Article En | MEDLINE | ID: mdl-37502378

Rationale and Objective: Frailty is common among people with kidney failure treated with hemodialysis (HD). The objective was to describe how frailty evolves over time in people treated by HD, how improvements in frailty and frailty markers are associate with clinical outcomes, and the characteristics that are associated with improvement in frailty. Study Design: Prospective cohort study. Setting and Participants: Adults initiating thrice weekly in-center HD in Canada. Exposure: We classified frailty using a 5-point score (3 or more indicates frailty) based on physical inactivity, slowness or weakness, poor endurance or exhaustion, and malnutrition. We categorized the frailty trajectory as never present, improving, deteriorating, and always present. Outcomes: All-cause death, hospitalizations, and placement into long-term care. Analytical Approach: We examined the association between time-varying frailty measures and these outcomes using Cox and negative binomial models, after adjustment for potential confounders. Results: 985 participants were included and followed up for a median of 33 months; 507 (51%) died, 761 (77%) experienced ≥1 hospitalization and 115 (12%) entered long-term care. Overall, 760 (77%) reported frailty during follow-up. Three-quarters (78%) of those with frailty at baseline remained frail throughout the follow-up, 46% without baseline frailty became frail, and 23% with baseline frailty became nonfrail. Higher frailty scores were associated with an increased risk of mortality (fully adjusted HR, 1.58 per unit; 95% CI, 1.39-1.80) and an increased rate of hospitalization (RR, 1.16 per unit; 95% CI, 1.09-1.23). Compared with those who were frail throughout the follow-up, participants with frailty at baseline but improving during follow-up showed a lower mortality (HR, 0.59; 95% CI, 0.42-0.81), and a lower rate of hospitalization (RR, 0.70; 95% CI, 0.56-0.87). Limitations: There was missing data on frailty at baseline and during follow-up. Conclusions: Frailty was associated with a higher risk of poor outcomes compared with those without frailty, and participants whose status improved from frail to nonfrail showed better clinical outcomes than those who remained frail. These findings emphasize the importance of identifying and implementing effective treatments for frailty in patients receiving maintenance HD.

11.
BMJ Open ; 13(5): e070837, 2023 05 11.
Article En | MEDLINE | ID: mdl-37169505

INTRODUCTION: Despite the availability of pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART), 21 793 people were newly diagnosed with HIV in Europe in 2019. The Concerted action on seroconversion to AIDS and death in Europe study aims to understand current drivers of the HIV epidemic; factors associated with access to, and uptake of prevention methods and ART initiation; and the experiences, needs and outcomes of people with recently acquired HIV. METHODS AND ANALYSIS: This longitudinal observational study is recruiting participants aged ≥16 years with documented laboratory evidence of HIV seroconversion from clinics in Canada and six European countries. We will analyse data from medical records, self-administered questionnaires, semistructured interviews and participatory photography. We will assess temporal trends in transmitted drug resistance and viral subtype and examine outcomes following early ART initiation. We will investigate patient-reported outcomes, well-being, and experiences of, knowledge of, and attitudes to HIV preventions, including PrEP. We will analyse qualitative data thematically and triangulate quantitative and qualitative findings. As patient public involvement is central to this work, we have convened a community advisory board (CAB) comprising people living with HIV. ETHICS AND DISSEMINATION: All respective research ethics committees have approval for data to contribute to international collaborations. Written informed consent is required to take part. A dissemination strategy will be developed in collaboration with CAB and the scientific committee. It will include peer-reviewed publications, conference presentations and accessible summaries of findings on the study's website, social media and via community organisations.


Acquired Immunodeficiency Syndrome , HIV Infections , Pre-Exposure Prophylaxis , Humans , HIV Infections/epidemiology , Acquired Immunodeficiency Syndrome/prevention & control , Canada , Europe , Pre-Exposure Prophylaxis/methods , Patient Reported Outcome Measures , Observational Studies as Topic , Multicenter Studies as Topic
12.
Am J Transplant ; 23(9): 1290-1299, 2023 09.
Article En | MEDLINE | ID: mdl-37217005

In June 2022, the US Food and Drug Administration Center for Biologics Evaluation and Research held the 73rd meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee for public discussion of regulatory expectations for xenotransplantation products. The members of a joint American Society of Transplant Surgeons/American Society of Transplantation committee on xenotransplantation compiled a meeting summary focusing on 7 topics believed to be key by the committee: (1) preclinical evidence supporting progression to a clinical trial, (2) porcine kidney function, (3) ethical aspects, (4) design of initial clinical trials, (5) infectious disease issues, (6) industry perspectives, and (7) regulatory oversight.


Motivation , Surgeons , United States , Animals , Swine , Humans , Transplantation, Heterologous , United States Food and Drug Administration
13.
Kidney Int Rep ; 8(4): 898-906, 2023 Apr.
Article En | MEDLINE | ID: mdl-37069985

Introduction: Travel for transplantation is the movement of organs, donors, recipients, or transplant professionals across jurisdictional borders for transplantation purposes and is considered transplant tourism if transplant commercialism is involved. Little is known about the willingness of patients at risk for transplant tourism to engage in this practice. Methods: A cross-sectional survey of patients with end-stage renal disease was conducted in Canada to determine interest in travel for transplantation and transplant tourism, characterize patients according to their willingness to consider transplant tourism, and identify factors to deter willingness to consider transplant tourism. Surveys were conducted face-to-face and in multiple languages. Results: Among the 708 patients surveyed, 418 (59%) reported a willingness to travel outside of Canada for transplantation, with 24% reporting a strong willingness. One hundred sixty-one (23%) reported a willingness to travel and purchase a kidney overseas. On multivariate analysis, male sex, younger age, and Pacific Islander ethnicity were associated with higher odds of willingness to travel for transplant, whereas male sex, annual income greater than $100,000, and Asian and Middle Eastern ethnicity were associated with higher odds of willing to travel to purchase a kidney. Willingness reduced when respondents were informed of medical risks and legal implications related to travel for transplantation. Financial and ethical considerations were less effective at reducing willingness to travel for transplantation. Conclusion: There was a high level of interest in travel for transplantation and transplant tourism. Legal consequences and education on medical risks of transplant tourism may be effective deterrent strategies.

14.
Article En | MEDLINE | ID: mdl-37027505

BACKGROUND: The Kidney Donor Profile Index (KDPI) is a percentile score summarizing the likelihood of allograft failure: A KDPI ≥85% is associated with shorter allograft survival, and 50% of these donated kidneys are not currently used for transplantation. Preemptive transplantation (transplantation without prior maintenance dialysis) is associated with longer allograft survival than transplantation after dialysis; however, it is unknown whether this benefit extends to high-KDPI transplants. The objective of this analysis was to determine whether the benefit of preemptive transplantation extends to recipients of transplants with a KDPI ≥85%. METHODS: This retrospective cohort study compared the post-transplant outcomes of preemptive and nonpreemptive deceased donor kidney transplants using data from the Scientific Registry of Transplant Recipients. 120,091 patients who received their first, kidney-only transplant between January 1, 2005, and December 31, 2017, were studied, including 23,211 with KDPI ≥85%. Of this cohort, 12,331 patients received a transplant preemptively. Time-to-event models for the outcomes of allograft loss from any cause, death-censored graft loss, and death with a functioning transplant were performed. RESULTS: Compared with recipients of nonpreemptive transplants with a KDPI of 0%-20% as the reference group, the risk of allograft loss from any cause in recipients of a preemptive transplant with KDPI ≥85% (hazard ratio [HR], 1.51; 95% confidence interval [CI], 1.39 to 1.64) was lower than that in recipients of nonpreemptive transplant with a KDPI ≥85% (HR, 2.39; 95% CI, 2.21 to 2.58) and similar to that of recipients of a nonpreemptive transplant with a KDPI of 51%-84% (HR, 1.61; 95% CI, 1.52 to 1.70). CONCLUSIONS: Preemptive transplantation is associated with a lower risk of allograft failure, irrespective of KDPI, and preemptive transplants with KDPI ≥85% have comparable outcomes with nonpreemptive transplants with KDPI 51%-84%.

15.
Am J Transplant ; 23(3): 316-325, 2023 03.
Article En | MEDLINE | ID: mdl-36906294

Solid organ transplantation provides the best treatment for end-stage organ failure, but significant sex-based disparities in transplant access exist. On June 25, 2021, a virtual multidisciplinary conference was convened to address sex-based disparities in transplantation. Common themes contributing to sex-based disparities were noted across kidney, liver, heart, and lung transplantation, specifically the existence of barriers to referral and wait listing for women, the pitfalls of using serum creatinine, the issue of donor/recipient size mismatch, approaches to frailty and a higher prevalence of allosensitization among women. In addition, actionable solutions to improve access to transplantation were identified, including alterations to the current allocation system, surgical interventions on donor organs, and the incorporation of objective frailty metrics into the evaluation process. Key knowledge gaps and high-priority areas for future investigation were also discussed.


Frailty , Organ Transplantation , Tissue and Organ Procurement , Female , Humans , Healthcare Disparities , Kidney , Tissue Donors , United States , Waiting Lists
16.
Clin Transplant ; 37(5): e14949, 2023 05.
Article En | MEDLINE | ID: mdl-36849704

INTRODUCTION: Significant center-to-center variation in attitudes and management of delayed graft function (DGF) remains common. METHODS: A survey to describe current DGF practices was developed by workgroup members sponsored by the National Kidney Foundation (NKF) and was distributed to both the NKF DGF workgroup members, kidney transplant program directors and the transplant community within the United States and Canada. Seventy-one percent of NKF workgroup members completed the survey along with 70 unique the United States and three Canadian kidney transplant programs. All Organ Procurement and Transplantation Network (OPTN) regions were represented. RESULTS: DGF was reported to occur at rate of 20%-40% for most centers with 3.9% indicating their incidence to be >60%. Most centers reported longer hospital lengths of stay and more frequent outpatient visits. Despite the commonality of DGF, only half of centers reported having an established protocol to manage DGF. Kidney allograft biopsies were the only consistent DGF management strategy observed, although use of machine perfusion was also heavily favored. Other DGF management strategies voiced by a minority included having established outpatient practices to care for DGF patients and administering outpatient community-based hemodialysis. CONCLUSION: Although approximately a third of survey responders indicated that risk of DGF played a role in their willingness to accept organs, most did not feel that increased cost or clinical impact on outcomes was a deterrent. Future strategies, including broader sharing of best practices, redefining terminology specific to DGF, the establishment of DGF dialysis guidelines and improving access to machine perfusion across OPOs may help reduce discard and improve utilization of kidneys at risk for DGF.


Kidney Transplantation , Kidney , United States/epidemiology , Humans , Canada/epidemiology , Emotions , Renal Dialysis
18.
Am J Transplant ; 23(2): 232-238, 2023 02.
Article En | MEDLINE | ID: mdl-36804131

The inclusion of blood group- and human leukocyte antigen-compatible donor and recipient pairs (CPs) in kidney paired donation (KPD) programs is a novel strategy to increase living donor (LD) transplantation. Transplantation from a donor with a better Living Donor Kidney Profile Index (LKDPI) may encourage CP participation in KPD programs. We undertook parallel analyses using data from the Scientific Registry of Transplant Recipients and the Australia and New Zealand Dialysis and Transplant Registry to determine whether the LKDPI discriminates death-censored graft survival (DCGS) between LDs. Discrimination was assessed by the following: (1) the change in the Harrell C statistic with the sequential addition of variables in the LKDPI equation to reference models that included only recipient factors and (2) whether the LKDPI discriminated DCGS among pairs of prognosis-matched LD recipients. The addition of the LKDPI to reference models based on recipient variables increased the C statistic by only 0.02. Among prognosis-matched pairs, the C statistic in Cox models to determine the association of the LKDPI with DCGS was no better than chance alone (0.51 in the Scientific Registry of Transplant Recipient and 0.54 in the Australia and New Zealand Dialysis and Transplant Registry cohorts). We conclude that the LKDPI does not discriminate DCGS and should not be used to promote CP participation in KPD programs.


Kidney Transplantation , Tissue and Organ Procurement , Humans , Living Donors , Kidney , Tissue and Organ Harvesting , Graft Survival , Allografts
20.
Transplant Direct ; 9(1): e1398, 2023 Jan.
Article En | MEDLINE | ID: mdl-36518792

Cardiovascular disease is a major cause of morbidity and mortality in kidney transplant recipients. Trial evidence to improve cardiovascular outcomes is limited by inconsistent reporting of outcomes, which may also lack patient-relevance. This study aimed to assess the range and consistency of cardiovascular outcomes reported by contemporary trials in kidney transplant recipients. Methods: A systematic review of all randomized controlled trials involving adult kidney transplant recipients that reported at least 1 cardiovascular outcome from January 2012 to December 2019 was performed, including Embase, MEDLINE, Cochrane, and ClinicalTrials.gov electronic databases. Trial characteristics were extracted and all levels of specification of the cardiovascular outcome measures reported were analyzed (the measure definition, metric' and method of aggregation). Measures assessing a similar aspect of cardiovascular disease were categorized into outcomes. Results: From 93 eligible trials involving 27 609 participants, 490 outcome measures were identified. The outcome measures were grouped into 38 outcomes. A cardiovascular composite was the most common outcome reported (40 trials, 43%) followed by cardiovascular mortality (42%) and acute coronary syndrome (31%). Cardiovascular composite was also the most heterogeneous outcome with 77 measures reported followed by cardiovascular mortality (n = 58) and inflammatory biomarkers (n = 51). The most common cardiovascular composite outcome components reported were major cardiovascular events (18 trials), stroke unspecified (11 trials), and myocardial infarction unspecified (10 trials). Conclusions: There is substantial heterogeneity in cardiovascular outcome reporting in kidney transplant trials.

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