Willingness of Kidney and Liver Transplant Candidates to Receive HCV-Infected Organs.

INTRODUCTION: Transplantation of organs exposed to hepatitis C virus (HCV) into uninfected patients has yielded excellent outcomes and more widespread adoption may lead to fewer discarded organs and more transplants. Patient perceptions may shed light on acceptability and likely the uptake of HCV+/HCV- transplantation, gaps in understanding, and perceived benefits/risks. METHODS: We surveyed 435 uninfected kidney and liver transplant candidates at four centers about their attitude towards HCV-infected organs. RESULTS: The percentage of patients willing to accept HCV-infected organs increased from 58% at baseline, to 86% following education about HCV, direct-acting antiviral agents (DAAs), and HCV+/HCV- transplantation benefits/risks. More willingness to accept an organ from an intravenous drug user (P < 0.001), age >50 y old (P = 0.02), longer waiting time (P = 0.02), more trust in the transplant system (P = 0.03), and previous awareness of DAAs (P = 0.04) were associated with higher willingness to accept an HCV-infected organ. The most important reasons for accepting an HCV-infected organ were a decrease in waiting time (65%), lower mortality and morbidity risk while on the waiting list (63%), effectiveness of DAAs (54%), and a quicker return to higher functional status (51%). CONCLUSIONS: Presenting patients with information about HCV+/HCV- transplantation in small doses that are calibrated to account for varying levels of health and numerical literacy is recommended.

Apolipoprotein L1 Opinions of African American Living Kidney Donors, Kidney Transplant Patients, and Nonpatients.

INTRODUCTION: The discovery of apolipoprotein L1 (ApoL1) has raised important ethical and clinical questions about genetic testing in the context of living and deceased kidney donation. Largely missing from this discussion are the perspectives of those African Americans (AA) most likely to be impacted by ApoL1 testing. METHODS: We surveyed 331 AA potential and former living kidney donors (LKDs), kidney transplant candidates and recipients, and nonpatients at three United States transplant programs about their ApoL1 testing attitudes. RESULTS: Overall, 72% felt that transplant programs should offer ApoL1 testing to AA potential LKDs. If a potential LKD has the high-risk genotype, 79% felt that the LKD should be allowed to make their own donation decision or participate in shared decision-making with transplant doctors. More than half of the potential LKDs (58%) would undergo ApoL1 testing and 81% of former LKDs would take the test now if offered. Most transplant candidates expressed a low likelihood of accepting a kidney from a LKD (79%) or a deceased donor (67%) with the high-risk genotype. CONCLUSIONS: There is strong support among LKDs and transplant patients for ApoL1 testing when evaluating potential kidney donors of African ancestry. Inclusion of AA stakeholders in developing guidelines and educational programs for ApoL1 testing is critical.

Opinions of African American adults about the use of apolipoprotein L1 (ApoL1) genetic testing in living kidney donation and transplantation.

Apolipoprotein L1 (ApoL1) predictive genetic testing for kidney disease, and its emerging role in transplantation, remains controversial as it may exacerbate underlying disparities among African Americans (AAs) at increased risk. We conducted an online simulation among AAs (N = 585) about interest in ApoL1 testing and its cofactors, under 2 scenarios: as a potential living donor (PLD), and as a patient awaiting transplantation. Most respondents (61%) expressed high interest in genetic testing as a PLD: age ≥35 years (adjusted odds ratio [aOR], 1.75; 95% confidence interval [CI], 1.18, 2.60, P = .01), AA identity (aOR, 1.67; 95% CI, 1.02, 2.72, P = .04), perceived kidney disease risk following donation (aOR, 1.68; 95% CI, 1.03, 2.73, P = .03), interest in genetics (aOR, 2.89; 95% CI, 1.95, 4.29, P = .001), and genetics self-efficacy (aOR, 2.38; 95% CI, 1.54, 3.67, P = .001) were positively associated with ApoL1 test interest. If awaiting transplantation, most (89%) believed that ApoL1 testing should be done on AA deceased donors, and older age (aOR, 1.85; 95% CI, 1.03, 3.32, P = .04) and greater interest in genetics (aOR, 2.61; 95% CI, 1.41, 4.81, P = .002) were associated with interest in testing deceased donors. Findings highlight strong support for ApoL1 testing in AAs and the need to examine such opinions among PLDs and transplant patients to enhance patient education efforts.

Wait expectations: The impact of delisting as an outcome from the kidney transplant waitlist.

BACKGROUND: While kidney transplantation is optimal for the treatment of end-stage kidney disease, available organs do not meet demand. Little is known about the outcomes of patients who are delisted (removed from the waitlist) and unable to benefit from transplant. We describe patients who are delisted and their life expectancy after delisting. METHODS: Patients ≥ 18 years listed for deceased donor kidney transplant between 01/2003 and 12/2013 were identified in the Scientific Registry of Transplant Recipients and followed through 12/2018. A competing risk model was used to measure the association of demographic and clinical factors with waitlist outcomes of delisting, transplant, and death. Multivariate Cox modeling was used to evaluate factors associated with death after delisting. RESULTS: Of 324,582 patients listed, 18.0% were delisted, most common reasons were "too sick" or "other." After delisting, half (49.7%) had died by end of follow-up; time to death after removal was 5 years. Increasing age and public insurance were associated with increased risk of death. CONCLUSIONS: Nearly one in five patients will be delisted from the kidney transplant waitlist. These patients live a surprisingly long time after removal. Much remains unknown about these patients, which could be improved through data collection. Delisting is an important patient outcome that warrants further exploration.

Metabolic, cardiovascular, and substance use evaluation of living kidney donor candidates: US practices in 2017.

We surveyed US transplant centers to assess practices regarding the evaluation and selection of living kidney donors based on metabolic, cardiovascular, and substance use risk factors. Our companion article describes renal aspects of the evaluation. Response rate was 31%. Compared with 2005, programs have become more accepting of hypertensive candidates: 65% in 2017% vs 41% in 2005 consider candidates with hypertension well controlled with 1 medication. One notable exception is black hypertensive candidates, who are frequently excluded regardless of severity. The most common body mass index (BMI) cutoff remains 35 kg/m2 , and fewer programs now consider candidates with BMI >40 kg/m2 . A 2-hour oral glucose tolerance test of ≥140 mg/dL remains the most common criterion for exclusion of prediabetic candidates. One quarter to one third of programs exclude based on isolated cardiac abnormalities, such as mild aortic stenosis; a similar proportion consider these candidates only if older than 50 years. Cigarette or marijuana smoking are infrequently criteria for exclusion, although 45% and 37% programs, respectively, require cessation 4 weeks prior to surgery. In addition to providing an overview of current practices in living kidney donor evaluation, our study highlights the importance of research evaluating outcomes with various comorbidities to guide practice.

The kidney evaluation of living kidney donor candidates: US practices in 2017.

We surveyed US transplant programs to assess practices used to assess kidney health in living kidney donor candidates in 2017; the response rate was 31%. In this report, we focus on the kidney; a companion piece focuses on the metabolic and cardiovascular aspects of candidate evaluation. Compared to 2005, programs have become more stringent in accepting younger candidates and less stringent in accepting older candidates. The 24-hour creatinine clearance remains the mainstay for kidney function assessment, with 74% continuing to use a value below 80 mL/min/1.73 m2 for exclusion and 22% using age-based criteria. ApoL1 genotyping is obtained routinely or selectively by 45%, half of which use the high-risk genotype as an absolute exclusion criterion. For history of symptomatic stones, 49% accept if there is no current radiographic evidence of stones and urine profile is low risk, 80%-95% consider candidates with unilateral asymptomatic stones, but only 33%-48% consider if stones are bilateral. In addition, 14% use the risk assessment tool developed by Grams et al routinely for decision-making, and 42% use it sometimes. Also, 57% reported not having yet determined a risk threshold for acceptable postdonation risk above which candidates are excluded. Contemporary practice variation underscores the need for better evidence to guide the donor selection process.

Patterns and predictors of fatigue following living donor nephrectomy: Findings from the KDOC Study.

This study sought to identify the prevalence, pattern, and predictors of clinical fatigue in 193 living kidney donors (LKDs) and 20 healthy controls (HCs) assessed at predonation and 1, 6, 12, and 24 months postdonation. Relative to HCs, LKDs had significantly higher fatigue severity (P = .01), interference (P = .03), frequency (P = .002), and intensity (P = .01), and lower vitality (P < .001), at 1-month postdonation. Using published criteria, significantly more LKDs experienced clinical fatigue at 1 month postdonation, compared to HCs, on both the Fatigue Symptom Inventory (60% vs. 37%, P < .001) and SF-36 Vitality scale (67% vs. 16%, P < .001). No differences in fatigue scores or clinical prevalence were observed at other time points. Nearly half (47%) reported persistent clinical fatigue from 1 to 6 months postdonation. Multivariable analyses demonstrated that LKDs presenting for evaluation with a history of affective disorder and low vitality, those with clinical mood disturbance and anxiety about future kidney failure after donation, and those with less physical activity engagement were at highest risk for persistent clinical fatigue 6 months postdonation. Findings confirm inclusion of fatigue risk in existing OPTN informed consent requirements, have important clinical implications in the care of LKDs, and underscore the need for further scientific examination in this population.

Pain expectancy, prevalence, severity, and patterns following donor nephrectomy: Findings from the KDOC Study.

Postoperative pain is an outcome of importance to potential living kidney donors (LKDs). We prospectively characterized the prevalence, severity, and patterns of acute or chronic postoperative pain in 193 LKDs at six transplant programs. Three pain measurements were obtained from donors on postoperative Day (POD) 1, 3, 7, 14, 21, 28, 35, 41, 49, and 56. The median pain rating total was highest on POD1 and declined from each assessment to the next until reaching a median pain-free score of 0 on POD49. In generalized linear mixed-model analysis, the mean pain score decreased at each pain assessment compared to the POD3 assessment. Pre-donation history of mood disorder (adjusted ratio of means [95% confidence interval (CI)]: 1.40 [0.99, 1.98]), reporting "severe" on any POD1 pain descriptors (adjusted ratio of means [95% CI]: 1.47 [1.12, 1.93]) and open nephrectomy (adjusted ratio of means [95% CI]: 2.61 [1.03, 6.62]) were associated with higher pain scores across time. Of the 179 LKDs who completed the final pain assessment, 74 (41%) met criteria for chronic postsurgical pain (CPSP), that is, any donation-related pain on POD56. Study findings have potential implications for LKD education, surgical consent, postdonation care, and outcome measurements.

KDOQI US Commentary on the 2017 KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors.

Living kidney donation is widely practiced throughout the world. During the past 2 decades, various groups have provided guidance about the evaluation and care of living donors. However, during this time, our knowledge in the field has advanced substantially and many agreed on the need for a comprehensive, unifying document. KDIGO (Kidney Disease: Improving Global Outcomes) addressed this issue at an international level with the publication of its clinical practice guideline on the evaluation and care of living kidney donors. The KDIGO work group extensively reviewed the available literature and wrote a series of guideline recommendations using various degrees of evidence when available. As has become recent practice, NKF-KDOQI (National Kidney Foundation-Kidney Disease Outcomes Quality Initiative) convened a work group to provide a commentary on the KDIGO guideline, with a focus on how these recommendations apply in the context of the United States. In the United States, the United Network for Organ Sharing (UNOS) guides and regulates the practice of living kidney donation. While the KDIGO guideline for the care of living kidney donors and UNOS policy are similar in most aspects of the care of living kidney donors, several important areas are not consistent or do not align with common practice by US transplantation programs in areas in which UNOS has not set specific policy. For the time being, and recognizing the value of the KDIGO guidelines, US transplantation programs should continue to follow UNOS policy.

Implementation, feasibility, and acceptability of quality of life therapy to improve positive emotions among patients with implantable cardioverter defibrillators.

Implantable cardioverter defibrillators (ICDs) save lives, but often induce significant psychological distress among patients. Positive psychological constructs are associated with improved outcomes among cardiac patients. In this NHLBI-funded randomized controlled trial, one aim was to evaluate the feasibility and acceptability of a positive psychology intervention (Quality of Life Therapy; QOLT, n = 11), compared to a Heart Healthy Education (HHE) control (n = 10), among ICD patients. A majority of participants across groups attended all 12 sessions (71%) and completed homework assignments (80%). Agreement on participant engagement and interventionist protocol adherence were high, with no differences between groups (ps > 0.20). A greater proportion of QOLT participants rated their sessions was "very" helpful compared to HHE participants (63% vs. 10%, p = 0.19). These initial data support the feasibility and acceptability of QOLT. A larger-scale trial using positive psychology interventions among ICD patients is indicated to determine potential mechanisms underlying the relationship between positive psychological constructs and cardiovascular health.

Increasing Organ Donor Designation Rates in Adolescents: A Cluster Randomized Trial.

Objectives. To evaluate the effectiveness of video messaging on adolescent organ donor designation rates.Methods. We randomized adolescent driver education classes in Massachusetts, between July 2015 and February 2018, to receive 1 of 3 organ donation video messaging interventions (informational, testimonial, or blended). Adolescents completed questionnaires before and after the intervention and at 1-week follow-up; we compared their registration status at time of obtaining driver's license with that of a regionally matched historical comparison group.Results. Donor designation rates were higher for those exposed to video messaging than for the historical comparison group (60% vs 50%; P < .001). Testimonial (64%) and blended messaging (65%) yielded higher donor designation rates than informational messaging (51%; P = .013). There was a statistically significant messaging × time interaction effect for donation knowledge (P = .03), with blended and informational messaging showing more gains in knowledge from before to after the intervention (P < .001; d = 0.69 and P < .001; d = 0.45, respectively), compared with testimonial messaging (d = 0.09; P = .22).Conclusions. Testimonial messaging is most effective in producing a verifiable and demonstrable impact on donor designation rates among adolescents, and driver education classes are an efficient venue for disseminating organ donation messaging to youths.Trial Registration. ClinicalTrials.gov; identifier: NCT03013816.

Design and Implementation of an Infrastructure Program to Support Clinical Research in Surgery.

Barriers to active participation in clinical research among academic surgeons include insufficient research training and mentorship, increased clinical demands, lack of protected research time, limited access to resources, complex regulatory requirements, and a highly competitive research funding environment. We describe the development and implementation of a novel clinical research infrastructure program designed to attenuate these barriers and increase clinical research engagement and productivity in a large academic surgery department. Interim outcomes show a high utilization of program services across all divisions within the department, a substantial increase in new clinical research protocols, more applications submitted to funding agencies, and a high level of user satisfaction. We discuss how a departmental infrastructure program can simultaneously address barriers faced by surgeon clinical researchers and foster continuation of the longstanding tradition of innovation and discovery in academic surgery.

Outcomes for individuals turned down for living kidney donation.

BACKGROUND: A better understanding of the consequences of being turned down for living kidney donation could help transplant professionals to counsel individuals considering donation. METHODS: In this exploratory study, we used survey instruments and qualitative interviews to characterize nonmedical outcomes among individuals turned down for living kidney donation between July 1, 2010 and December 31, 2013. We assembled a comparator group of kidney donors. RESULTS: Among 83 turned-down donors with contact information at a single center, 43 (52%) participated in the study (median age 53 years; 53% female; 19% black). Quality of life, depression, financial stress, and provider empathy scores were similar between individuals turned down for donation (n = 43) and donors (n = 128). Participants selected a discrete choice response to a statement about the overall quality of their lives; 32% of turned-down donors versus 7% of donors (P < 0.01) assessed that their lives were worse after the center's decision about whether they could donate a kidney. Among turned-down donors who reported that life had worsened, 77% had an intended recipient who was never transplanted, versus 36% among individuals who assessed life as the same or better (P = 0.02). In interviews, the majority of turned-down donors reported emotional impact, including empathy, stress, and other challenges, related to having someone in their lives with end-stage kidney disease. CONCLUSIONS: Generic instruments measuring quality of life, depression, financial stress, and provider empathy revealed no significant differences between kidney donors and turned-down donors. However, qualitative interviews revealed preliminary evidence that some turned-down donors experienced emotional consequences. These findings warrant confirmation in larger studies.

Measuring Critical Care Providers' Attitudes About Controlled Donation After Circulatory Death.

INTRODUCTION: Unfavorable attitudes and insufficient knowledge about donation after cardiac death among critical care providers can have important consequences for the appropriate identification of potential donors, consistent implementation of donation after cardiac death policies, and relative strength of support for this type of donation. The lack of reliable and valid assessment measures has hampered research to capture providers' attitudes. Design and Research Aims: Using stakeholder engagement and an iterative process, we developed a questionnaire to measure attitudes of donation after cardiac death in critical care providers (n = 112) and examined its psychometric properties. Exploratory factor analysis, internal consistency, and validity analyses were conducted to examine the measure. RESULTS: A 34-item questionnaire consisting of 4 factors (Personal Comfort, Process Satisfaction, Family Comfort, and System Trust) provided the most parsimonious fit. Internal consistency was acceptable for each of the subscales and the total questionnaire (Cronbach α > .70). A strong association between more favorable attitudes overall and knowledge ( r = .43, P < .001) provides evidence of convergent validity. Multivariable regression analyses showed that white race ( P = .002) and more experience with donation after cardiac death ( P < .001) were significant predictors of more favorable attitudes. CONCLUSION: Study findings support the utility, reliability, and validity of a questionnaire for measuring attitudes in critical care providers and for isolating targets for additional education on donation after cardiac death.

Readability, content analysis, and racial/ethnic diversity of online living kidney donation information.

More than three-fourths of adults in the USA use the Internet to access health-related information. Adults exploring the possibility of living donation should have access to online content that is readable and comprehensive. We simulated a search of online information about living kidney donation and evaluated readability, topics covered, and racial/ethnic diversity of 21 websites meeting inclusion criteria (eg, hosted by a nonprofit or patient advocacy organization, English content, based in USA). Using standard readability metrics, 62% of sites were classified as "Difficult to read" and none achieved the recommended reading level of sixth grade. On average, websites covered 18.5 (62%) of 30 recommended information topics (range: 7 to 28) and only 2.1 (23%) of 9 racial/ethnic diversity items (range: 0 to 6). Overall, the most common nonprofit or patient advocacy organization websites do not meet the readability standards established by the National Institutes of Health and the American Medical Association, many lack fundamental information about living kidney donation, and most are not racially/ethnically diverse. We encourage the transplant community to consider playing a more active role in improving the overall quality of online information disseminated to the general public. Further, there is a need to more critically examine the accuracy of online living donation content in future investigations.

Practices in the evaluation of potential kidney transplant recipients who are elderly: A survey of U.S. transplant centers.

Limited data exist regarding the evaluation and selection of older candidates for transplantation. To help guide the development of program protocols and help define research questions in this area, we surveyed U.S. transplant centers regarding their current practices in the evaluation of older kidney transplant candidates. We emailed a 28-question survey to the medical and surgical directors of 190 adult kidney transplant programs in the USA. We received usable responses from 59 programs, a 31.1% response rate. Most (76.3%) programs do not have absolute age cutoffs for listing patients, but for the 22.0% of programs that do have cutoffs, the mean age was 79, range 70-90. Nearly one-third (29.2%) of programs require a minimum life expectancy to list for transplant, reporting a mean of 4.5 years life expectancy, (range 2-10). Programs vary significantly in evaluating candidates living in a nursing home or with cognitive impairments. Practices regarding the evaluation of older transplant candidates vary widely between U.S. programs. Further studies are needed on the impact of age and other comorbidities on transplant outcomes, to help guide decisions on which older patients are most appropriate for transplant listing.

Ethical and Logistical Issues Raised by the Advanced Donation Program "Pay It Forward" Scheme.

The advanced donation program was proposed in 2014 to allow an individual to donate a kidney in order to provide a voucher for a kidney in the future for a particular loved one. In this article, we explore the logistical and ethical issues that such a program raises. We argue that such a program is ethical in principle but there are many logistical issues that need to be addressed to ensure that the actual program is fair to both those who do and do not participate in this program.

Massachusetts Healthcare Reform and Trends in Emergent Colon Resection.

BACKGROUND: Insurance impacts access to therapeutic options, yet little is known about how healthcare reform might change the pattern of surgical admissions. OBJECTIVE: We compared rates of emergent admissions and outcomes after colectomy before and after reform in Massachusetts with a nationwide control group. DESIGN: This study is a retrospective cohort analysis in a natural experiment. Prereform was defined as hospital discharge from 2002 through the second quarter of 2006 and postreform from the third quarter of 2006 through 2012. Categorical variables were compared by χ. Piecewise functions were used to test the effect of healthcare reform on the rate of emergent surgeries. SETTINGS: The study included acute care hospitals in the Massachusetts Healthcare Cost and Utilization Project State Inpatient Database (2002-2012) and the Nationwide Inpatient Sample (2002-2011). PATIENTS: Patients aged 18 to 64 years with public or no insurance who underwent inpatient colectomy (via International Classification of Diseases, Ninth Revision, Clinical Modification procedural code) were included and patients with Medicare were excluded. INTERVENTION: Massachusetts health care reform was the study intervention. MAIN OUTCOME MEASURES: We measured the rate of emergent colectomy, complications, and mortality. RESULTS: The unadjusted rate of emergent colectomies was lower in Massachusetts after reform but did not change nationally over the same time period. For emergent surgeries in Massachusetts, a piecewise model with an inflection point (peak) in the third quarter of 2006, coinciding with implementation of healthcare reform in Massachusetts, had a lower mean squared error than a linear model. In comparison, the national rate of emergent surgeries demonstrated no change in pattern. Postreform, length of stay decreased by 1 day in Massachusetts; however, there were no significant improvements in other outcomes. LIMITATIONS: The study was limited by its retrospective design and unadjusted analysis. CONCLUSIONS: There was a unique and sustained decline in the rate of emergent colon resection among publically insured and uninsured patients after 2006 in Massachusetts, in contradistinction to the national pattern, suggesting improved access to care associated with health insurance expansion. The reasons for lack of improvement in outcomes are multifactorial.

Positive Psychotherapy to Improve Autonomic Function and Mood in ICD Patients (PAM-ICD): Rationale and Design of an RCT Currently Underway.

BACKGROUND: Improving mental and physical health of patients with implantable cardioverter defibrillators (ICD) is critical because this group is at high risk for ventricular arrhythmias and sudden death and depressed or anxious cardiovascular disease (CVD) patients appear to be at even higher risk for mortality compared to nondepressed or nonanxious CVD patients. Further, autonomic dysfunction is present in these patients, and negative emotions and arrhythmias form a downward spiral further worsening mood, well-being, and cardiovascular health. Much research demonstrates that positive emotion is related to health benefits, improved physiology, and increased survival. METHODS AND RESULTS: This is a two-arm randomized controlled trial aiming to recruit 60 adult ICD patients comparing 12 individually delivered, weekly sessions of: (1) a positive emotion-focused cognitive-behavioral therapy (Quality of Life Therapy [QOLT]), and (2) Heart Healthy Education. Autonomic functioning, heart rhythm indices, and psychosocial health are measured at baseline, 3 months, and 9 months. The first goal is feasibility and acceptability, with the primary outcome being arrhythmic event frequency data. CONCLUSION: This study is designed to test whether QOLT produces changes in mood, quality of life/well-being, autonomic function, and arrhythmic and ICD therapy event rates. This feasibility trial is a foundational step for the next trial of QOLT to help determine whether a 3-month QOLT trial can reduce arrhythmias occurrences among ICD patients, and examine a mechanism of autonomic functioning. This study may help to develop and implement new medical or psychological therapies for ICD patients.