The 10-Year Effects of Intensive Lifestyle Intervention on Kidney Outcomes.

Rationale & Objective: Limited data exist on longitudinal kidney outcomes after nonsurgical obesity treatments. We investigated the effects of intensive lifestyle intervention on kidney function over 10 years. Study Design: Post hoc analysis of Action for Health in Diabetes (Look AHEAD) randomized controlled trial. Setting & Participants: We studied 4,901 individuals with type 2 diabetes and body mass index of ≥25 kg/m2 enrolled in Look AHEAD (2001-2015). The original Look AHEAD trial excluded individuals with 4+ urine dipstick protein, serum creatinine level of >1.4 mg/dL (women), 1.5 mg/dL (men), or dialysis dependence. Exposures: Intensive lifestyle intervention versus diabetes support and education (ie, usual care). Outcome: Primary outcome was estimated glomerular filtration rate (eGFR, mL/min/1.73 m2) slope. Secondary outcomes were mean eGFR, slope, and mean urine albumin to creatinine ratio (UACR, mg/mg). Analytical Approach: Linear mixed-effects models with random slopes and intercepts to evaluate the association between randomization arms and within-individual repeated measures of eGFR and UACR. We tested for effect modification by baseline eGFR. Results: At baseline, mean eGFR was 89, and 83% had a normal UACR. Over 10 years, there was no difference in eGFR slope (+0.064 per year; 95% CI: -0.036 to 0.16; P = 0.21) between arms. Slope or mean UACR did not differ between arms. Baseline eGFR, categorized as eGFR of <80, 80-100, or >100, did not modify the intervention's effect on eGFR slope or mean. Limitations: Loss of muscle may confound creatinine-based eGFR. Conclusions: In patients with type 2 diabetes and preserved kidney function, intensive lifestyle intervention did not change eGFR slope over 10 years. Among participants with baseline eGFR <80, lifestyle intervention had a slightly higher longitudinal mean eGFR than usual care. Further studies evaluating the effects of intensive lifestyle intervention in people with kidney disease are needed.

Lifestyle interventions can improve chronic kidney disease risk factors, specifically diabetes, hypertension, and obesity. But, the effects of lifestyle intervention on change in kidney function (estimated glomerular filtration rate [eGFR]) over time are not well established. We studied Action for Health in Diabetes (Look AHEAD) trial data because all participants were affected by diabetes and overweight or obesity. Look AHEAD randomized participants to intensive lifestyle intervention or diabetes support and education (ie, usual care). We compared eGFR change over 10 years between groups, but found no difference. However, the intervention group maintained slightly higher eGFR than usual care, especially if eGFR was relatively low at baseline. Our study suggests lifestyle intervention may preserve eGFR, but dedicated studies in individuals with chronic kidney disease are needed.

Referral and Beyond: Restructuring the Kidney Transplant Process to Support Greater Access in the United States.

Advocates for improved equity in kidney transplant in the US have recently focused efforts on initiatives to increase referral for transplant evaluation. However, because donor kidneys remain scarce, increased referrals are likely to result in an increasing number of patients proceeding through the evaluation process without ultimately receiving a kidney. Unfortunately, the process of referral and evaluation can be highly resource-intensive for patients, families, transplant programs, and payers. Patients and families may incur out-of-pocket expenses and be required to complete testing and treatments that they might not have chosen in the course of routine clinical care. Kidney transplant programs may struggle with insufficient capacity, inefficient workflow, and challenging programmatic finances and payers will need to absorb the increased expenses of upfront pretransplant costs. Increased referral in isolation may risk simply transmitting system stress and resulting disparities to downstream processes in this complex system. We argue that success in efforts to improve access through increased referrals hinges on adaptations to the pretransplant process more broadly. We call for an urgent reevaluation and redesign at multiple levels of the pretransplant system in order to achieve the aim of equitable access to kidney transplantation for all patients with kidney failure.

Association of Race and Ethnicity With High Longevity Deceased Donor Kidney Transplantation Under the US Kidney Allocation System.

RATIONALE & OBJECTIVE: The US Kidney Allocation System (KAS) prioritizes candidates with ≤20% Estimated Post-Transplant Survival (EPTS) for high longevity kidneys defined by a ≤20% Kidney Donor Profile Index (KDPI). Use of EPTS in the KAS deprioritizes candidates with older age, diabetes, and longer dialysis durations. We assessed whether this use also disadvantages racial-ethnic minority candidates, who are younger but more likely to have diabetes and longer durations of kidney failure requiring dialysis. STUDY DESIGN: Observational cohort study. SETTING: & Participants: Adult candidates for and recipients of kidney transplantation represented in the Scientific Registry of Transplant Recipients from January 2015 through December 2020. EXPOSURE: Race and ethnicity. OUTCOMES: Age-adjusted assignment to ≤20% EPTS, transplantation of a ≤20% KDPI kidney, and post-transplant survival in longevity matched recipients by racial-ethnicity. ANALYTIC APPROACH: Multivariable logistic regression, Fine-Gray competing risks survival analysis, and Kaplan-Meier and Cox Proportional Hazards methods. RESULTS: The cohort included 199,444 candidates (7% Asian, 29% Black, 19% Hispanic/Latino, 43% White) listed for deceased donor kidney transplantation. Non-White candidates had significantly higher rates of diabetes, longer dialysis duration, and were younger than White candidates. Adjusted for age, Asian, Black, and Hispanic/Latino candidates had significantly lower odds of having a ETPS score ≤20% (OR 0.86, [0.81, 0.91], 0.52 [0.50, 0.54], and 0.49, [0.47, 0.51]), and were less likely to receive a ≤20% KDPI kidney (subHR 0.70 [0.66, 0.75], 0.89 [0.87, 0.92], and 0.73 [0.71, 0.76]), compared to White candidates. Among recipients with ≤20% EPTS scores transplanted with a ≤20% KDPI deceased donor kidney, Asian and Hispanic recipients had lower post-transplant mortality (HR 0.45 [0.27, 0.77], and 0.63 [0.47, 0.86]) and Black recipients had higher but not statistically significant post-transplant mortality (HR 1.22 [0.99, 1.52]) compared to White recipients. LIMITATIONS: Provider reported race-ethnicity data and 5-year post transplant follow-up period. CONCLUSIONS: The US kidney allocation system is less likely to identify racial-ethnic minority candidates as having a ≤20% EPTS score which triggers allocation of high longevity deceased donor kidneys. These findings should inform the OPTN about how to remedy racial/ethnic disparities introduced through KAS's current approach of allocating allografts with longer predicted longevity to recipients with longer estimated post-transplant survival.

Knowledge gaps in heart and lung donation after the circulatory determination of death: Report of a workshop of the National Heart, Lung, and Blood Institute.

In a workshop sponsored by the U.S. National Heart, Lung, and Blood Institute, experts identified current knowledge gaps and research opportunities in the scientific, conceptual, and ethical understanding of organ donation after the circulatory determination of death and its technologies. To minimize organ injury from warm ischemia and produce better recipient outcomes, innovative techniques to perfuse and oxygenate organs postmortem in situ, such as thoracoabdominal normothermic regional perfusion, are being implemented in several medical centers in the US and elsewhere. These technologies have improved organ outcomes but have raised ethical and legal questions. Re-establishing donor circulation postmortem can be viewed as invalidating the condition of permanent cessation of circulation on which the earlier death determination was made and clamping arch vessels to exclude brain circulation can be viewed as inducing brain death. Alternatively, TA-NRP can be viewed as localized in-situ organ perfusion, not whole-body resuscitation, that does not invalidate death determination. Further scientific, conceptual, and ethical studies, such as those identified in this workshop, can inform and help resolve controversies raised by this practice.

Characterizing proximity and transfers of deceased organ donors to donor care units in the United States.

Some United States organ procurement organizations transfer deceased organ donors to donor care units (DCUs) for recovery procedures. We used Organ Procurement and Transplantation Network data, from April 2017 to June 2021, to describe the proximity of adult deceased donors after brain death to DCUs and understand the impact of donor service area (DSA) boundaries on transfer efficiency. Among 19 109 donors (56.1% of the cohort) in 25 DSAs with DCUs, a majority (14 593 [76.4%]) were in hospitals within a 2-hour drive. In areas with DCUs detectable in the study data set, a minority of donors (3582 of 11 532 [31.1%]) were transferred to a DCU; transfer rates varied between DSAs (median, 27.7%, range, 4.0%-96.5%). Median hospital-to-DCU driving times were not meaningfully shorter among transferred donors (50 vs 51 minutes for not transferred, P < .001). When DSA boundaries were ignored, 3241 cohort donors (9.5%) without current DCU access were managed in hospitals within 2 hours of a DCU and thus potentially eligible for transfer. In summary, approximately half of United States deceased donors after brain death are managed in hospitals in DSAs with a DCU. Transfer of donors between DSAs may increase DCU utilization and improve system efficiency.

A Machine Learning-Driven Virtual Biopsy System For Kidney Transplant Patients.

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.

A randomized, controlled, prehabilitation intervention to maximize early recovery (PRIMER) in liver transplantation.

Frailty and impaired functional status are associated with adverse outcomes on the liver transplant (LT) waitlist and after transplantation. Prehabilitation prior to LT has rarely been tested. We conducted a 2-arm patient-randomized pilot trial to evaluate the feasibility and efficacy of a 14-week behavioral intervention to promote physical activity prior to LT. Thirty patients were randomized 2:1 to intervention (n = 20) versus control (n = 10). The intervention arm received financial incentives and text-based reminders linked to wearable fitness trackers. Daily step goals were increased by 15% in 2-week intervals. Weekly check-ins with study staff assessed barriers to physical activity. The primary outcomes were feasibility and acceptability. Secondary outcomes included mean end-of-study step counts, short physical performance battery, grip strength, and body composition by phase angle. We fit regression models for secondary outcomes with the arm as the exposure adjusting for baseline performance. The mean age was 61, 47% were female, and the median Model for End-stage Liver Disease sodium (MELD-Na) was 13. One-third were frail or prefrail by the liver frailty index, 40% had impaired mobility by short physical performance battery, nearly 40% had sarcopenia by bioimpedance phase angle, 23% had prior falls, and 53% had diabetes. Study retention was 27/30 (90%; 2 unenrolled from intervention, 1 lost to follow-up in control arm). Self-reported adherence to exercise during weekly check-ins was about 50%; the most common barriers were fatigue, weather, and liver-related symptoms. End-of-study step counts were nearly 1000 steps higher for intervention versus control: adjusted difference 997, 95% CI, 147-1847; p = 0.02. On average, the intervention group achieved daily step targets 51% of the time. A home-based intervention with financial incentives and text-based nudges was feasible, highly accepted, and increased daily steps in LT candidates with functional impairment and malnutrition.

Temporal trends in kidney paired donation in the United States: 2006-2021 UNOS/OPTN database analysis.

Kidney paired donation (KPD) is a major innovation that is changing the landscape of kidney transplantation in the United States. We used the 2006-2021 United Network for Organ Sharing data to examine trends over time. KPD is increasing, with 1 in 5 living donor kidney transplants (LDKTs) in 2021 facilitated by KPD. The proportion of LDKT performed via KPD was comparable for non-Whites and Whites. An increasing proportion of KPD transplants are going to non-Whites. End-chain recipients are not identified in the database. To what extent these trends reflect how end-chain kidneys are allocated, as opposed to increase in living donation among minorities, remains unclear. Half the LDKT in 2021 in sensitized (panel reactive antibody ≥ 80%) and highly sensitized (panel reactive antibody ≥ 98%) groups occurred via KPD. Yet, the proportion of KPD transplants performed in sensitized recipients has declined since 2013, likely due to changes in the deceased donor allocation policies and newer KPD strategies such as compatible KPD. In 2021, 40% of the programs reported not performing any KPD transplants. Our study highlights the need for understanding barriers to pursuing and expanding KPD at the center level and the need for more detailed and accurate data collection at the national level.

Transplant recipient, care partner, and clinician perceptions of medication adherence monitoring technology: A mixed methods study.

Medication nonadherence is a leading cause of graft loss. Adherence monitoring technologies-reminder texts, smart bottles, video-observed ingestion, and digestion-activated signaling pills-may support adherence. However, patient, care partner, and clinician perceptions of these tools are not well studied. We conducted qualitative individual semistructured interviews and focus groups among 97 participants at a single center: kidney and liver transplant recipients 2 weeks to 18 months posttransplant, their care partners, and transplant clinicians. We assessed adherence practices, reactions to monitoring technologies, and opportunities for care integration. One-size-fits-all approaches were deemed infeasible. Interviewees considered text messages the most acceptable approach; live video checks were the least acceptable and raised the most concerns for inconvenience and invasiveness. Digestion-activated signaling technology produced both excitement and apprehension. Patients and care partners generally aligned in perceptions of adherence monitoring integration into clinical care. Key themes were importance of routine, ease of use, leveraging technology for actionable medication changes, and aversion to surveillance. Transplant clinicians similarly considered text messages most acceptable and video checks least acceptable. Clinicians reported that early posttransplant use and real-time adherence tracking with patient feedback may facilitate successful implementation. The study provides initial insights that may inform future adherence technology implementation.

Engineering Equity Into the Promise of Xenotransplantation.

Two of the greatest challenges facing kidney transplantation are the lack of donated organs and inequities in who receives a transplant. Xenotransplantation holds promise as a treatment approach that could solve the supply problem. Major advances in gene-editing procedures have enabled several companies to raise genetically engineered pigs for organ donation. These porcine organs lack antigens and have other modifications that should reduce the probability of immunological rejection when transplanted into humans. The US Food and Drug Administration and transplantation leaders are starting to chart a path to test xenotransplants in clinical trials and later integrate them into routine clinical care. Here we provide a framework that industry, regulatory authorities, payers, transplantation professionals, and patient groups can implement to promote equity during every stage in this process. We also call for immediate action. Companies developing xenotransplant technology should assemble patient advocacy boards to bring the concerns of individuals with end-stage kidney disease to the forefront. For trials, xenotransplantation companies should partner with transplant programs with substantial patient populations of racial and ethnic minority groups and that have reciprocal relationships with those communities. Those companies and transplant programs should reach out now to those communities to inform them about xenotransplantation and try to address their concerns. These actions have the potential to make these communities full partners in the promise of xenotransplantation.

Deceased Organ Donor Management and Organ Distribution From Organ Procurement Organization-Based Recovery Facilities Versus Acute-Care Hospitals.

Introduction: Organ recovery facilities address the logistical challenges of hospital-based deceased organ donor management. While more organs are transplanted from donors in facilities, differences in donor management and donation processes are not fully characterized. Research Question: Does deceased donor management and organ transport distance differ between organ procurement organization (OPO)-based recovery facilities versus hospitals? Design: Retrospective analysis of Organ Procurement and Transplant Network data, including adults after brain death in 10 procurement regions (April 2017-June 2021). The primary outcomes were ischemic times of transplanted hearts, kidneys, livers, and lungs. Secondary outcomes included transport distances (between the facility or hospital and the transplant program) for each transplanted organ. Results: Among 5010 deceased donors, 51.7% underwent recovery in an OPO-based recovery facility. After adjustment for recipient and system factors, mean differences in ischemic times of any transplanted organ were not significantly different between donors in facilities and hospitals. Transplanted hearts recovered from donors in facilities were transported further than hearts from hospital donors (median 255 mi [IQR 27, 475] versus 174 [IQR 42, 365], P = .002); transport distances for livers and kidneys were significantly shorter (P < .001 for both). Conclusion: Organ recovery procedures performed in OPO-based recovery facilities were not associated with differences in ischemic times in transplanted organs from organs recovered in hospitals, but differences in organ transport distances exist. Further work is needed to determine whether other observed differences in donor management and organ distribution meaningfully impact donation and transplantation outcomes.

Cognitive function, self-management, and outcomes among liver transplant recipients: LivCog, a multicenter, prospective study.

Liver transplantation is a life-saving option for decompensated cirrhosis. Liver transplant recipients require advanced self-management skills, intact cognitive skills, and care partner support to improve long-term outcomes. Gaps remain in understanding post-liver transplant cognitive and health trajectories, and patient factors such as self-management skills, care partner support, and sleep. Our aims are to (1) assess pre-liver transplant to post-liver transplant cognitive trajectories and identify risk factors for persistent cognitive impairment; (2) evaluate associations between cognitive function and self-management skills, health behaviors, functional health status, and post-transplant outcomes; and (3) investigate potential mediators and moderators of associations between cognitive function and post-liver transplant outcomes. LivCog is a longitudinal, prospective observational study that will enroll 450 adult liver transplant recipients and their caregivers/care partners. The duration of the study is 5 years with 24 additional months of patient follow-up. Data will be collected from participants at 1, 3, 12, and 24 months post-transplant. Limited pre-liver transplant data will also be collected from waitlisted candidates. Data collection methods include interviews, surveys, cognitive assessments, and actigraphy/sleep diary measures. Patient measurements include sociodemographic characteristics, pretransplant health status, cognitive function, physical function, perioperative measures, medical history, transplant history, self-management skills, patient-reported outcomes, health behaviors, and clinical outcomes. Caregiver measures assess sociodemographic variables, health literacy, health care navigation skills, self-efficacy, care partner preparedness, nature and intensity of care, care partner burden, and community participation. By elucidating various health trajectories from pre-liver transplant to 2 years post-liver transplant, LivCog will be able to better characterize recipients at higher risk of cognitive impairment and compromised self-management. Findings will inform interventions targeting health behaviors, self-management, and caregiver supports to optimize outcomes.

Social network interventions to reduce race disparities in living kidney donation: Design and rationale of the friends and family of kidney transplant patients study (FFKTPS).

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.

The SHELTER Trial of Transplanting Hepatitis C Virus-Infected Lungs Into Uninfected Recipients.

SHELTER is a trial of transplanting lungs from deceased donors with hepatitis C virus (HCV) infection into HCV-negative candidates (sponsor: Merck; NCT03724149). Few trials have reported outcomes using thoracic organs from HCV-RNA+ donors and none have reported quality of life (QOL). Methods: This study is a single-arm trial of 10 lung transplants at a single center. Patients were included who were between 18 and 67 y of age and waitlisted for lung-only transplant. Patients were excluded who had evidence of liver disease. Primary outcome was HCV cure (sustained virologic response 12 wk after completing antiviral therapy). Recipients longitudinally reported QOL using the validated RAND-36 instrument. We also applied advanced methods to match HCV-RNA+ lung recipients to HCV-negative lung recipients in a 1:3 ratio at the same center. Results: Between November 2018 and November 2020, 18 patients were consented and opted-in for HCV-RNA+ lung offers in the allocation system. After a median of 37 d (interquartile range [IQR], 6-373) from opt-in, 10 participants received double lung transplants. The median recipient age was 57 y (IQR, 44-67), and 7 recipients (70%) had chronic obstructive pulmonary disease. The median lung allocation score at transplant was 34.3 (IQR, 32.7-86.9). Posttransplant, 5 recipients developed primary graft dysfunction grade 3 on day 2 or 3, although none required extracorporeal membrane oxygenation. Nine patients received elbasvir/grazoprevir, whereas 1 patient received sofosbuvir/velpatasvir. All 10 patients were cured of HCV and survived to 1 y (versus 83% 1-y survival among matched comparators). No serious adverse events were found to be related to HCV or treatment. RAND-36 scores showed substantial improvement in physical QOL and some improvement in mental QOL. We also examined forced expiratory volume in 1 s-the most important lung function parameter after transplantation. We detected no clinically important differences in forced expiratory volume in 1 s between the HCV-RNA+ lung recipients versus matched comparators. Conclusions: SHELTER adds important evidence regarding the safety of transplanting HCV-RNA+ lungs into uninfected recipients and suggests QOL benefits.

Dialysis Patients' Social Networks and Living Donation Offers.

Rationale & Objective: Most living kidney donors are members of a hemodialysis patient's social network. Network members are divided into core members, those strongly connected to the patient and other members; and peripheral members, those weakly connected to the patient and other members. We identify how many hemodialysis patients' network members offered to become kidney donors, whether these offers were from core or peripheral network members, and whose offers the patients accepted. Study Design: A cross-sectional interviewer-administered hemodialysis patient social network survey. Setting & Participants: Prevalent hemodialysis patients in 2 facilities. Predictors: Network size and constraint, a donation from a peripheral network member. Outcomes: Number of living donor offers, accepting an offer. Analytical Approach: We performed egocentric network analyses for all participants. Poisson regression models evaluated associations between network measures and number of offers. Logistic regression models determined the associations between network factors and accepting a donation offer. Results: The mean age of the 106 participants was 60 years. Forty-five percent were female, and 75% self-identified as Black. Fifty-two percent of participants received at least one living donor offer (range 1-6); 42% of the offers were from peripheral members. Participants with larger networks received more offers (incident rate ratio [IRR], 1.26; 95% CI, 1.12-1.42; P = 0.001), including networks with more peripheral members (constraint, IRR, 0.97; 95% CI, 0.96-0.98; P < 0.001). Participants who received a peripheral member offer had 3.6 times greater odds of accepting an offer (OR, 3.56; 95% CI, 1.15-10.8; P = 0.02) than those who did not receive a peripheral member offer. Limitations: A small sample of only hemodialysis patients. Conclusions: Most participants received at least one living donor offer, often from peripheral network members. Future living donor interventions should focus on both core and peripheral network members.

Patients' Experiences With the Removal of a Ureteral Stent: Insights From In-depth Interviews With Participants in the USDRN STENTS Qualitative Cohort Study.

OBJECTIVE: To describe the experiences of patients undergoing stent removal in the USDRN Study to Enhance Understanding of Stent-Associated Symptoms (STENTS), a prospective, observational cohort study of patients with short-term ureteral stent placement post-ureteroscopy. METHODS: We conducted a qualitative descriptive study using in-depth interviews. Participants reflected on (1) painful or bothersome aspects of stent removal, (2) symptoms immediately after removal, and (3) symptoms in the days following removal. Interviews were audio-recorded, transcribed, and analyzed using applied thematic analysis. RESULTS: The 38 participants interviewed were aged 13-77 years, 55% female, and 95% White. Interviews were conducted 7-30 days after stent removal. Almost all participants (n = 31) described that they experienced either pain or discomfort during stent removal, but for most (n = 25) pain was of short duration. Many participants (n = 21) described anticipatory anxiety related to the procedure, and several (n = 11) discussed discomfort arising from lack of privacy or feeling exposed. Interactions with medical providers often helped put participants at ease, but also increased discomfort for some. Following stent removal, several participants described lingering pain and/or urinary symptoms, but these largely resolved within 24 hours. A few participants described symptoms persisting for more than a day post stent removal. CONCLUSION: These findings on patients' experiences during and shortly after ureteral stent removal, particularly the psychological distress they experienced, identify opportunities for improvement in patient care. Clear communication from providers about what to expect with the removal procedure, and the possibility of delayed pain, may help patients adapt to discomfort.

American Society of Transplant Surgeons-American Society of Transplantation report of FDA meeting on regulatory expectations for xenotransplantation products.

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.

The Patient Voice: Stent Experiences After Ureteroscopy-Insights from In-Depth Interviews with Participants in the USDRN STENTS Nested Qualitative Cohort Study.

Purpose: Ureteral stents are commonly used after ureteroscopy and cause significant discomfort, yet qualitative perspectives on patients' stent experiences remain unknown. We describe psychological, functional, and interpersonal effects of post-ureteroscopy stents and whether additional patient-reported assessments may be needed. Materials and Methods: Using a qualitative descriptive study design, we conducted in-depth interviews with a nested cohort of participants in the STudy to Enhance uNderstanding of sTent-associated Symptoms (STENTS). Participants shared their symptoms with a post-ureteroscopy stent and described symptom bother and impact on daily activities. All interviews were audio-recorded, transcribed, and analyzed using applied thematic analysis. During analysis, participants' experiences with interference in daily activities were categorized into three groups based on their impact: minimal, moderate, and substantial. Results: All 39 participants experienced pain, although descriptions varied and differentiated between feelings of pain vs discomfort. Almost all experienced urinary symptoms. Only a few reported other physical symptoms, although several psychological aspects were identified. In the areas of sleep, mood, life enjoyment, work, exercise, activities of daily living, driving, childcare, and leisure/social activities, the stent had little impact on daily living among participants placed in the minimal group (n = 12) and far greater impact for participants in the substantial group (n = 8). For patients in the moderate group (n = 19), some daily activities were moderately or substantially affected, whereas other activities were minimally affected. Conclusions: Counseling to better prepare patients for the impact of stent-associated symptoms may help mitigate symptom burden. While existing instruments adequately cover most symptoms, additional assessments for other domains, particularly psychological factors, may be needed.

Contribution of Estimates of Glomerular Filtration to the Extensive Disparities in Preemptive Listing for Kidney Transplant.

Introduction: The use of race coefficients in equations for estimated glomerular filtration rate (eGFR) may have contributed to racial disparities in access to preemptive (without dialysis exposure) kidney transplantation (Ktx). Methods: In this retrospective national cohort study of incident kidney transplant candidates in the United States from 2001 to 2019, we describe temporal trends and racial disparities in preemptive listing and the distribution of eGFR at listing, using eGFR as reported and after removing the race coefficient for Black candidates. Results: Among 511,686 candidates, preemptive listing increased over time, from 18% in 2001 to 33% in 2019. Non-Black candidates were listed preemptively nearly twice as frequently as Black candidates in 2019 (38% vs. 21% preemptive) and at higher eGFR values (median 15.6 vs. 15.0 ml/min per 1.73 m2). After adjusting for candidate characteristics, including listing eGFR without the race coefficient, preemptive Black candidates still had significantly lower odds of preemptive deceased donor (DD) kidney transplantation compared to non-Black candidates (odds ratio 0.87, 95% confidence interval: 0.78-0.98). Conclusions: Over the last 2 decades, Black patients were consistently less likely to be listed preemptively and were listed at lower eGFR values. Adjusting for listing eGFR with the race coefficient computationally removed did not eliminate the racial disparity, suggesting that additional efforts are needed to achieve equity in preemptive transplantation beyond adopting race-free eGFR equations.