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This was an economic analysis of a 12-month, parallel arm, randomized controlled trial in adult kidney recipients 6 to 36 months posttransplant (NCT03247322). All participants received usual posttransplant care, while the intervention arm received supplemental clinical pharmacist-led medication therapy monitoring and management, via a smartphone-enabled mHealth app, integrated with risk-based televisits. Hospitalization charges were captured from the study institution accounts payable and non-study institution hospitalization charges were estimated using multiple imputation. Multivariable modeling was used to assess the impact of the intervention on charges. The intervention significantly reduced rates of hospitalization (1.08 per patient-year in the control arm vs 0.65 per patient-year in the intervention arm, p = .007). The control arm had estimated hospitalization costs of $870,468 vs $390,489 in the intervention arm. Modeling demonstrated a 49% lower hospitalization charge risk in the intervention arm (RR 0.51, 95% CI 0.28-0.91; p = .022). From a payer or societal perspective, the net estimated cost savings, after accounting for intervention delivery costs, was $368,839, with a return on investment (ROI) of $4.30 for every $1 spent. These results demonstrate that a mHealth-enabled, pharmacist-led intervention significantly reduced hospitalization costs for payers over a 12-month period and has a positive ROI.

Background Medication safety issues have detrimental implications on long-term outcomes in the high-risk kidney transplant (KTX) population. Medication errors, adverse drug events, and medication nonadherence are important and modifiable mechanisms of graft loss. Objective To describe the frequency and types of interventions made during a pharmacist-led, mobile health–based intervention in KTX recipients and the impact on patient risk levels. Methods This was a secondary analysis of data collected during a 12-month, parallel-arm, 1:1 randomized clinical controlled trial including 136 KTX recipients. Participants were randomized to receive either usual care or supplemental, pharmacist-driven medication therapy monitoring and management using a smartphone-enabled app integrated with telemonitoring of blood pressure and glucose (when applicable) and risk-based televisits. The primary outcome was pharmacist intervention type. Secondary outcomes included frequency of interventions and changes in risk levels. Results A total of 68 patients were randomized to the intervention and included in this analysis. The mean age at baseline was 50.2 years; 51.5% of participants were male, and 58.8% were black. Primary pharmacist intervention types were medication reconciliation and patient education, followed by medication changes. Medication reconciliation remained high throughout the study period, whereas education and medication changes trended downward. From baseline to month 12, we observed an approximately 15% decrease in high-risk patients and a corresponding 15% increase in medium- or low-risk patients. Conclusion and Relevance A pharmacist-led mHealth intervention may enhance opportunities for pharmacological and nonpharmacological interventions and mitigate risk levels in KTX recipients.

BACKGROUND Death with a functioning allograft has become the leading category of graft loss in kidney transplant recipients at all time points. Previous analyses have demonstrated that causes of death in kidney transplant recipients are predominated by comorbidities with strong associations with immunosuppressant medications. Adverse drug events (ADEs) have been strongly associated with nonadherence, healthcare utilization, and graft loss; clinicians face a difficult decision on whether making immunosuppressant adjustments in the face of ADEs will provide improved symptomology or simply increase risk of acute rejection. Clinicians also face a treatment quandary in the 50% of kidney transplant recipients with stage 3 or worse chronic kidney disease at 1-year post-transplant, as progressive decline in renal function has been strongly associated with inferior allograft survival. OBJECTIVE The primary objective of the CLARITY Trial is to evaluate change in renal function over time in recipients of kidney transplants who are undergoing OmniGrafTM monitoring in conjunction with patient medication-related burden (MRB) monitoring. A secondary objective is to identify the impact of OmniGrafTM use, in conjunction with patient-reported MRB, as part of clinical care on patient self-efficacy and quality of life (QoL). METHODS The CLARITY Trial is a 3-year, prospective, multisite, observational study with a matched control group. RESULTS The primary outcome measure of the study will be the comparison of the slope change in estimated glomerular filtration rate (eGFR) from baseline to the end of follow-up between study participants and a matched control group. Secondary outcome measures include changes over time in Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions – Managing Medications and Treatment-Short Form 4a, the PROMIS-29 Profile v2.1, and PROMIS Depression Scale in the study group, as well as a comparison of hospitalizations and causes, rejections, and graft and patient survival compared between subjects and a matched cohort. CONCLUSIONS With this report we describe the study design, methods, and outcome measures that will be utilized in the ongoing CLARITY clinical trial. CLINICALTRIAL pending

Background and objectives Medication safety events are predominant contributors to suboptimal graft outcomes in kidney transplant recipients. The goal of this study was to examine the efficacy of improving medication safety through a pharmacist-led, mobile health–based intervention. Design, setting, participants, & measurements This was a 12-month, single-center, prospective, parallel, two-arm, single-blind, randomized controlled trial. Adult kidney recipients 6–36 months post-transplant were eligible. Participants randomized to intervention received supplemental clinical pharmacist–led medication therapy monitoring and management via a mobile health–based application, integrated with risk-guided televisits and home-based BP and glucose monitoring. The application provided an accurate medication regimen, timely reminders, and side effect surveys. Both the control and intervention arms received usual care, including serial laboratory monitoring and regular clinic visits. The coprimary outcomes were to assess the incidence and severity of medication errors and adverse events. Results In total, 136 kidney transplant recipients were included, 68 in each arm. The mean age was 51 years, 57% were male, and 64% were Black individuals. Participants receiving the intervention experienced a significant reduction in medication errors (61% reduction in the risk rate; incident risk ratio, 0.39; 95% confidence interval, 0.28 to 0.55; P Conclusions We demonstrated a significant reduction in medication errors, adverse events, and hospitalizations using a pharmacist-led, mobile health–based intervention.

Purpose Nonadherence is a leading cause of death-censored allograft loss in kidney transplant recipients. Strong associations have tied tacrolimus intrapatient variability (IPV) to degree of nonadherence and high tacrolimus IPV to clinical endpoints such as rejection and allograft loss. Nonadherence is a dynamic, complex problem best targeted by multidimensional interventions, including mobile health (mHealth) technologies. Methods This was a secondary planned analysis of a 12-month, parallel, 2-arm, semiblind, 1:1 randomized controlled trial involving 136 adult kidney transplant recipients. The primary aims of the TRANSAFE Rx study were to assess the efficacy of a pharmacist-led, mHealth-based intervention in improving medication safety and health outcomes for kidney transplant recipients as compared to usual care. Results Patients were randomized equally to 68 patients per arm. The intervention arm demonstrated a statistically significant decrease in tacrolimus IPV over time as compared to the control arm (P = 0.0133). When analyzing a clinical goal of tacrolimus IPV of less than 30%, the 2 groups were comparable at baseline (P = 0.765), but significantly more patients in the intervention group met this criterion at month 12 (P = 0.033). In multivariable modeling, variables that independently impacted tacrolimus IPV included time, treatment effect, age, and warm ischemic time. Conclusion This secondary planned analysis of an mHealth-based, pharmacist-led intervention demonstrated an association between the active intervention in the trial and improved tacrolimus IPV. Further prospective studies are required to confirm the mutability of tacrolimus IPV and impact of reducing tacrolimus IPV on long-term clinical outcomes.

Objectives The purpose of this study was to determine the impact of a mandate from 2 large insurers in South Carolina for mandatory review of the state’s prescription drug monitoring program (PDMP) for controlled substance (CS) prescriptions for more than 5 days’ supply on the proportion of opioid prescriptions for less than or equal to 5 days in a statewide adult population. In addition, changes in the mean morphine milligram equivalents (MME) per day for prescriptions for 5 days or less were described to evaluate prescribing changes. Design, setting and participants All prescriptions for opioids written for and filled by adults (≥ 18 years of age) and reported to the PDMP from January 1, 2010, to December 31, 2017, were included in an interrupted time series analysis. Outcome measures An interrupted time series analysis was performed to determine if there was a significant change in the proportion of opioid prescriptions for less than or equal to 5 days’ supply. Results Overall opioid prescriptions decreased over the time period by 11.5%, including a decreasing rate of opioid prescriptions for less than or equal to 5 days’ supply. There was no statistical difference in the slope between the pre- and postmandate cohorts (P = 0.077, r2 = 0.951). There was not an identified corresponding increase in the MME per day of prescriptions. Conclusion Our analysis found that 2 major insurer mandates that occurred in South Carolina in 2016, which required a review of the state PDMP for CS prescriptions for more than 5 days’ supply, did not have a significant impact on the proportion of opioid prescriptions for less than or equal to 5 days’ supply in the statewide population. In addition, we did not find any concern that prescribers attempted to circumvent the requirement by inappropriately adjusting dosing instructions.

Background The formal recommendation for converting twice-daily tacrolimus immediate release (IR) to once-daily tacrolimus extended release (ER) is a 1:1 dose conversion. However, more recent clinical analysis has shown that this may not be true; some patients may require a higher dose. In addition, de novo dosing tacrolimus ER has revealed that African Americans require approximately 20%-30% higher doses than Caucasians to achieve similar levels. As a result, this study sought to identify the appropriate dose conversion in the African American kidney transplant population, a population at high risk of rejection. Methods This was a single-center, prospective, open-label study comparing the difference in dose-normalized trough and total daily dose necessary to reach steady-state therapeutic goal, after conversion from tacrolimus IR to tacrolimus ER, in 25 African American kidney transplant recipients. Results After conversion to tacrolimus ER, there was a significant decrease in dose-normalized trough (C0) (0.44 versus 0.59, P = 0.03). Statistically significant differences were seen in both total daily and weight-based doses, when reported as actual values (15 versus 10 mg and 0.16 versus 0.11 mg/kg, respectively), as well as when standardized to achieve a target tacrolimus C0 of 8 ng/mL (18.1 versus 13.6 mg and 0.17 versus 0.15 mg/kg, respectively). The median standardized dose conversion required was 1.3 [1.0, 1.4], for the overall population. There were no instances of biopsy-proven acute rejection, allograft loss, or study drug discontinuation. Conclusions This single-center, open-label conversion study demonstrated that there was a statistically and clinically significant decrease in dose-normalized trough after conversion from tacrolimus IR to tacrolimus ER in an African American kidney transplant population and that a 1:1 dose conversion is unlikely to meet therapeutic goals.

Purpose The development, testing, and preliminary validation of a technology-enabled, pharmacist-led intervention aimed at improving medication safety and outcomes in kidney transplant recipients are described. Summary Medication safety issues, encompassing medication errors (MEs), medication nonadherence, and adverse drug events (ADEs), are a predominant cause of poor outcomes after kidney transplantation. However, a limited number of clinical trials assessing the effectiveness of technology in improving medication safety and outcomes in transplant recipients have been conducted. Through an iterative, evidence-based approach, a technology-enabled intervention aimed at improving posttransplant medication safety outcomes was developed, tested, and preliminarily validated. Early acceptability and feasibility results from a prospective, randomized controlled trial assessing the effectiveness of this system are reported here. Of the 120 patients enrolled into the trial at the time of writing, 60 were randomly assigned to receive the intervention. At a mean ± S.D. follow-up of 5.8 ± 4.0 months, there were 2 patient dropouts in the intervention group, resulting in a retention rate of 98%, which was higher than the expected 90% retention rate. Conclusion The development and deployment of a comprehensive medication safety monitoring dashboard for kidney transplant recipients is feasible and acceptable to patients in the current healthcare environment. An ongoing randomized controlled clinical trial is assessing whether such a system reduces MEs and ADRs, leading to improved patient outcomes.

The purpose of the Share 35 allocation policy was to improve liver transplant waitlist mortality, targeting high MELD waitlisted patients. However, policy changes may also have unintended consequences that must be balanced with the primary desired outcome. We performed an interrupted time series assessing the impact of Share 35 on biliary complications in a select national liver transplant population using the Vizient CDB/RM database. Liver transplants that occurred between October 2012 and September 2015 were included. There was a significant change in the incident-rate of biliary complications between Pre-Share 35 (n = 3018) and Post-Share 35 (n = 9984) cohorts over time (P = .023, r2 = .44). As a control, a subanalysis was performed throughout the same time period in Region 9 transplant centers, where a broad sharing agreement had previously been implemented. In the subanalysis, there was no change in the incident-rate of biliary complications between the two time periods. Length of stay and mean direct cost demonstrated a change after implementation of Share 35, although they did not meet statistical difference. While the target of improved waitlist mortality is of utmost importance for the equitable allocation of organs, unintended consequences of policy changes should be studied for a full assessment of a policy's impact.

Background Liver transplantation is a complex surgical procedure. The experience of the anesthesiologist, and its potential relationship to patient morbidity and mortality, is yet to be determined. We sought to explore this possible association using our institutional training patterns as the subject of study. Methods This is a single center retrospective analysis investigating the association of an anesthesiologist's experience with liver transplantation and its potential effect on early patient outcomes in adult liver transplant recipients from January 2010 to September 2016. Training of team members consisted of a 6-month period of clinical shadowing with a senior anesthesiologist and co-staffing 8 liver transplant procedures before solo staffing a liver transplant. Specifically, patient outcomes for the first 5 transplants after this training were investigated. Results The only independent risk factor for early death or early graft loss was the amount of packed red blood cells administered during transplantation. With respect to secondary outcomes, the amount of packed red blood cells and hospitalization at the time of transplant were associated with the number of days on a ventilator, length of intensive care unit stay, and overall hospital length of stay. Conclusions The results of this study conclude that the training model currently in place for our new team members has no negative impact on patient outcomes after liver transplantation.

Opioid use after kidney transplant has been shown to be a risk factor for chronic opioid use, which leads to an increased risk of mortality. The purpose of this study was to evaluate the early impact of a multimodal pain regimen and education quality improvement program on opioid use after kidney transplant 2 months after implementation. This was a retrospective, single-center analysis of post-operative opioid use, comparing the average daily Morphine milligram equivalents (MME) of the patients who received education on opioids and a multimodal pain regimen (preoperative TAP/QL block, scheduled APAP and gabapentin) compared to a historical control group. Despite having no differences in pre-transplant opioid exposure, daily and overall inpatient opioid utilization was significantly reduced in the multimodal pain protocol cohort (38.6 vs 8.0 MME/day; P < .001); 5% of patients in the multimodal pain protocol cohort were discharged with an opioid prescription, compared to 96% of controls (P < .001). Our early results demonstrate that a multimodal pain protocol can effectively and dramatically reduce short-term opioid utilization in kidney transplant recipients.

Study objective Opioid use has been associated with significant morbidity and mortality in the United States. Studies within kidney transplantation have also shown increased risk of mortality, graft loss, and complications in kidney transplant recipients who use opioids prior to transplant. The objective of this analysis was to identify if recent pretransplant opioid exposure would be an effective risk-stratifier for patients at risk for readmissions and readmission costs. Further, the objective was to see if a brief assessment of recent opioid use could predict chronic opioid use post-transplant." Patients and design This study was a single-center, retrospective cohort analysis of adult renal transplant recipients between January 2010 and December 2016 assessing the impact of pretransplant opioid use on posttransplant readmissions at 1 year postsurgery, as well as it's ability to identify patients at risk of chronic opioid use post-transplant. Opioid use was identified using medication reconciliation or a national prescription database, and readmissions and normalized costs for hospitalizations were identified via the Vizient clinical database. Main results Pretransplant opioid exposure occurred in 271 (24%) of 1129 patients transplanted during the study time period. There were no differences in index hospitalization length of stay or cost; however, patients with opioid exposure were significantly more likely to have been admitted within 1-year postsurgery (51 vs. 43%, p = 0.023), had more readmissions per patient (0.93 vs. 0.72, p = 0.010), and had higher normalized readmissions costs ($12,556 vs. $8344, p = 0.009). Patients with opioid exposure were also more likely to be admitted for readmissions, had more admissions per patient, and had higher readmission costs at 30 and 90 days postsurgery. There were no differences in preventability of readmissions between cohorts or in general causes of readmissions. A multivariable logistic regression demonstrated that being opioid experienced and having a history of diabetes mellitus were independently associated with readmissions at 1 year postsurgery. In addition, having opioid exposure at the time of transplant, a history of diabetes mellitus, and younger age were independently associated with chronic opioid use after transplant. Conclusion This study demonstrated that recent exposure to opioids prior to kidney transplant was significantly and independently associated with increased readmissions and readmission costs at multiple timepoints up to 1 year posttransplant as well as chronic opioid use after transplant.It also demonstrated that a brief assessment of recent opioid use may be able to identify patients at risk for chronic opioid use. Because opioid use is associated with multiple diseases, it is important to continue to study the association of opioid use, and the potential for disease-modifying interactions, with various clinical outcomes.

Medication non-adherence is common after transplant and a major contributor to graft loss. The objective of this pilot study was to obtain preliminary safety and adherence data of a complete once-daily immunosuppression regimen of Extended-release-tacrolimus (LCP-tac), everolimus, and prednisone vs LCP-tac, mycophenolate Twice daily (BID), and prednisone through a randomized controlled pilot study of 40 patients (20 in each arm). At 3 ± 2 months post-transplant, patients were randomized to receive LCP-tac and everolimus once daily or LCP-tac and mycophenolate BID (control arm) for 6 months; 80 met eligibility, and 40 were randomized. Mean age was 51 ± 14 years, 33% were female, 45% African American, and 55% had a Calculated panel reactive antibody (cPRA) >20%. Both regimens were well-tolerated, and medication side effect burden tended to be less severe in the intervention group. Self-reported high medication adherence decreased in the control arm from baseline to 6 months (80%-59%), while remaining the same in the intervention arm throughout the study (45%-47%). For safety assessment, there was no rejection, graft loss, or death in either arm. These results provide preliminary evidence of the safety of a novel once-daily immunosuppression regimen. The impact of this once-daily regimen on medication adherence requires a larger long-term study.

Despite being in existence for >40 years, the application of telemedicine has lagged significantly in comparison to its generated interest. Detractors include the immobile design of most historic telemedicine interventions and the relative lack of smartphones among the general populace. Recently, the exponential increase in smartphone ownership and familiarity have provided the potential for the development of mobile health (mHealth) interventions that can be mirrored realistically in clinical applications. Existing studies have demonstrated some potential clinical benefits of mHealth in the various phases of solid organ transplantation (SOT). Furthermore, studies in nontransplant chronic diseases may be used to guide future studies in SOT. Nevertheless, substantially more must be accomplished before mHealth becomes mainstream. Further evidence of clinical benefits and a critical need for cost-effectiveness analysis must prove its utility to patients, clinicians, hospitals, insurers, and the federal government. The SOT population is an ideal one in which to demonstrate the benefits of mHealth. In this review, the current evidence and status of mHealth in SOT is discussed, and a general path forward is presented that will allow buy-in from the health care community, insurers, and the federal government to move mHealth from research to standard care.

Introduction Transplant nurse (RN) coordinators review tacrolimus levels frequently and would be capable of making dose adjustments autonomously if not limited by their license. Collaborative practice agreements could be an answer; thus, the aim of this evaluation was to determine if an RN-driven protocol could be used safely and effectively to manage tacrolimus in ambulatory kidney transplant (KTX) recipients. Methods This was a retrospective review of all solitary adult KTX recipients between August 1, 2016, and July 29, 2017. The primary objective was to evaluate protocol adherence and frequency of use, and secondary objectives were to evaluate the utility of the protocol both overall and based on ethnicity. Results A total of 173 patients were included in the evaluation (59% African American [AA], 41% non-African American [non-AA). RN coordinators followed the protocol for 75% of tacrolimus adjustments; however, they only responded to 27% of the overall levels. There was no difference in 180-day tacrolimus-associated readmission (15% AA vs 5% non-AA, P = .06), biopsy-proven acute rejection (4% AA vs 7% non-AA, P = .363), or hyperkalemia (34% AA vs 32% non-AA, P = .87) between groups. Conclusions Transplant nurse coordinators are capable of accurately following a protocol for tacrolimus dosage adjustment in a large, racially diverse kidney transplant center.

A lack of research exploring post-transplant process optimization to reduce readmissions and increasing readmission rates at our center from 2009 to 2013 led to this study, aimed at assessing the effect of patient and process factors on 30-d readmission rates after kidney transplantation. This was a retrospective case-control study in adult kidney transplant recipients. Univariate and multivariate analyses were utilized to assess patient and process determinants of 30-d readmissions. 384 patients were included; 30-d readmissions were significantly associated with graft loss and death (p = 0.001). Diabetes (p = 0.049), pharmacist identification of poor understanding or adherence, and prolonged time on hemodialysis prior to transplant were associated with an increased risk of 30-d readmissions. After controlling for risk factors, readmission rates were only independently predicted by pharmacist identification of patient lack of understanding or adherence regarding post-transplant medications and dialysis exposure for more than three yr (OR 2.3, 95% CI 1.10-4.71, p = 0.026 and OR 2.1, 95% CI 1.22, 3.70, respectively), both of which were significantly modified by history of diabetes. Thirty-d readmissions are attributable to both patient and process-level factors. These data suggest that a lack of post-transplant medication knowledge in high-risk patients drives early hospital readmission.

Background There is a lack of conclusive evidence to suggest if calcineurin inhibitor (CNI) withdrawal or minimization with sirolimus is the best strategy for African Americans. Methods This was a randomized, prospective, open-label, pilot study comparing the two mammalian target of rapamycin (mTOR) transition strategies in adult African Americans between six and 24 wk post-transplant. The primary outcome was a comparison of the eGFR at one yr after conversion. Results Forty patients were randomized and analyzed in an intent-to-treat fashion. Median day of transition was day 96 (withdrawal) and 68 (minimization). Patients in the CNI-withdrawal group (n = 23) had significantly higher eGFR at one yr compared to the CNI-minimization group (n = 17, 73 vs. 56 mL/min, p = 0.03), as well as a significantly larger increase in eGFR from baseline (12 vs. 5 mL/min, p = 0.03). There were no differences in infections, acute rejection, death, or graft loss. Both regimens were constrained by disproportionately high discontinuation rates despite modest toxicity profiles. Conclusion In spite of considerable withdrawal rate across both study arms, African American kidney transplant recipients who underwent early transition to a sirolimus-based CNI-withdrawal regimen had significantly better graft function at one yr compared to those transitioned to a sirolimus-based CNI-minimization regimen. Clinicaltrials.gov identifier: NCT01005706.

Right heart catheterizations (RHC) are often performed prior to liver transplantation (LT) to rule out significant portopulmonary hypertension. Many times, elevated left heart filling pressures are found consistent with Heart Failure with Preserved Ejection Fraction (HFpEF). Pre-transplant HFpEF has

An improved understanding of the impact of clinical surrogates on disparities in African-American (AA) kidney transplantation (KTX) is needed. We conducted a 10-year retrospective longitudinal cohort study of electronically abstracted clinical data assessing the impact of surrogates on disparities in KTX. Clinical surrogates were assessed by post-transplant year (1, 2, 3 or 4) and defined as acute rejection (Banff≥1A), mean SBP >140 mmHg, tacrolimus variability (CV) >40%, mean glucose >160 mg/dL and mean hemoglobin

Background Up to 77% of liver transplantation candidates experience pain, and the majority are prescribed opioids. Previous studies have shown increased readmissions and mortality in liver transplant recipients who were prescribed opioids before transplantation. Our aim was to identify specific populations that are at the highest risk for deleterious outcomes with opioid use before transplantation. Study Design This was a single-center retrospective cohort study of adult receiving liver transplants between 2010 and 2016 to assess the impact of pretransplantation opioid use on mortality and graft loss after liver transplantation. Results A total of 446 liver transplant recipients were included in the study, 148 (33%) of which were identified as pretransplantation opioid users. Opioid use increased significantly during the course of the study. There were no differences in the overall cohort between opioid users and non-opioid users with regard to graft or patient outcomes. However, the influence of opioid use on outcomes varied based on Model for End-Stage Liver Disease (MELD) and functional status. In patients with any MELD exception, opioid use was an independent predictor of time to graft loss or death (adjusted hazard ratio 2.36; 95% CI 1.05 to 5.28; p = 0.037). It also independently predicted time to graft loss or death in patients with low laboratory MELD scores (adjusted hazard ratio 2.38; 95% CI 1.10 to 5.13; p = 0.027). Conclusions In our 6-year retrospective cohort, pretransplantation opioid use based on medication reconciliation was independently associated with time to graft loss or mortality in liver transplant recipients with MELD exceptions and laboratory MELD scores ≤15.

This national survey sought to determine the practices and policies pertaining to opioid and opioid substitution therapy (OST) use in the selection of liver transplant (LT) candidates. Of 114 centers, 61 (53.5%) responded to the survey, representing 49.2% of the LT volume in 2016. Only two programs considered chronic opioid (1 [1.6%]) or OST use (1 [1.6%]) absolute contraindications to transplant, while 63.9% and 37.7% considered either one a relative contraindication, respectively. The majority of programs did not have a written policy regarding chronic opioid use (73.8%) or OST use (78.7%) in LT candidates. Nearly half (45.9%) of centers agreed that there should be a national consensus policy addressing opioid and OST use. The majority of responding LT centers did not consider opioid or OST use in LT candidates to be absolute contraindications to LT, but there was significant variability in center practices. These surveys also demonstrated a lack of written policies in the assessment of the candidacy of such patients. The results of our survey identify an opportunity to develop a national consensus statement regarding opioid and OST use in LT candidates to bring greater uniformity and equity into the selection of LT candidates.

Low tacrolimus concentrations have been associated with higher risk of acute rejection, particularly within African American (AA) kidney transplant recipients; little is known about intrapatient tacrolimus variabilities impact on racial disparities.Ten year, single-center, longitudinal cohort study of kidney recipients. Intrapatient tacrolimus variability was assessed using the coefficient of variation (CV) measured between 1 month posttransplant and the clinical event, with a comparable period assessed in those without events. Pediatrics, nontacrolimus/mycophenolate regimens, and nonrenal transplants were excluded. Multivariable Cox regression models were used to analyze data.One thousand four hundred eleven recipients were included (54.4% AA) with 39 521 concentrations used to assess intrapatient tacrolimus CV. Overall, intrapatient tacrolimus CV was higher in AAs versus non-AAs (39.9 ± 19.8 % vs 34.8 ± 15.8% P0.001). Tacrolimus variability was a significant risk factor for deleterious clinical outcomes. A 10% increase in tacrolimus CV augmented the risk of acute rejection by 20% (adjusted hazard ratio, 1.20, 1.13-1.28; P0.001) and the risk of graft loss by 30% (adjusted hazard ratio, 1.30, 1.23-1.37; P0.001), with significant effect modification by race for acute rejection, but not graft loss. High tacrolimus variability (CV40%) was a significant explanatory variable for disparities in AAs; the crude relative risk of acute rejection in AAs was reduced by 46% when including tacrolimus variability in modeling and reduced by 40% for graft loss.These data demonstrate that intrapatient tacrolimus variability is strongly associated with acute rejection in AAs and graft loss in all patients. Tacrolimus variability is a significant explanatory variable for disparities in AA recipients.

Despite the rapidly increasing prevalence of obesity in the transplant population, the optimal management of obese liver transplant candidates remains undefined. Setting strict body mass index cutoffs for transplant candidacy remains controversial, with limited data to guide this practice. Body mass index is an imperfect measure of surgical risk in this population, partly due to volume overload and variable visceral adiposity. Weight loss before transplantation may be beneficial, but it remains important to avoid protein calorie malnutrition and sarcopenia. Intensive lifestyle modifications appear to be successful in achieving weight loss, though the durability of these interventions is not known. Pretransplant and intraoperative bariatric surgeries have been performed, but large randomized controlled trials are lacking. Traditional cardiovascular comorbidities are more prevalent in obese individuals and remain the basis for pretransplant cardiovascular evaluation and risk stratification. The recent US liver transplant experience demonstrates comparable patient and graft survival between obese and nonobese liver transplant recipients, but obesity presents important medical and surgical challenges during and after transplant. Specifically, obesity is associated with an increased incidence of wound infections, wound dehiscence, biliary complications and overall infection, and confers a higher risk of posttransplant obesity and metabolic syndrome-related complications. In this review, we examine current practices in the obese liver transplant population, offer recommendations based on the currently available data, and highlight areas where additional research is needed.

BACKGROUND Medication errors, adverse drug events, and nonadherence are the predominant causes of graft loss in kidney transplant recipients and lead to increased healthcare utilization. Research has demonstrated that clinical pharmacists have the unique education and training to identify these events early and develop strategies to mitigate or prevent downstream sequelae. In addition, studies utilizing mHealth interventions have demonstrated success in improving the control of chronic conditions that lead to kidney transplant deterioration. OBJECTIVE The goal of the prospective, randomized TRANSAFE Rx study is to measure the clinical and economic effectiveness of a pharmacist-led, mHealth-based intervention, as compared to usual care, in kidney transplant recipients. METHODS TRANSAFE Rx is a 12-month, parallel, two-arm, 1:1 randomized controlled clinical trial involving 136 participants (68 in each arm) and measuring the clinical and economic effectiveness of a pharmacist-led intervention which utilizes an innovative mobile health application to improve medication safety and health outcomes, as compared to usual posttransplant care. RESULTS The primary outcome measure of this study will be the incidence and severity of MEs and ADRs, which will be identified, categorized, and compared between the intervention and control cohorts. The exploratory outcome measures of this study are to compare the incidence and severity of acute rejections, infections, graft function, graft loss, and death between research cohorts and measure the association between medication safety issues and these events. Additional data that will be gathered includes sociodemographics, health literacy, depression, and support. CONCLUSIONS With this report we describe the study design, methods, and outcome measures that will be utilized in the ongoing TRANSAFE Rx clinical trial. CLINICALTRIAL ClinicalTrials.gov NCT03247322: https://clinicaltrials.gov/ct2/show/NCT03247322 (Archived by WebCite at http://www.webcitation.org/6xcSUnuzW)

Background: Medication errors, adverse drug events, and nonadherence are the predominant causes of graft loss in kidney transplant recipients and lead to increased healthcare utilization. Research has demonstrated that clinical pharmacists have the unique education and training to identify these events early and develop strategies to mitigate or prevent downstream sequelae. In addition, studies utilizing mHealth interventions have demonstrated success in improving the control of chronic conditions that lead to kidney transplant deterioration. Objective: The goal of the prospective, randomized TRANSAFE Rx study is to measure the clinical and economic effectiveness of a pharmacist-led, mHealth-based intervention, as compared to usual care, in kidney transplant recipients. Methods: TRANSAFE Rx is a 12-month, parallel, two-arm, 1:1 randomized controlled clinical trial involving 136 participants (68 in each arm) and measuring the clinical and economic effectiveness of a pharmacist-led intervention which utilizes an innovative mobile health application to improve medication safety and health outcomes, as compared to usual posttransplant care. Results: The primary outcome measure of this study will be the incidence and severity of MEs and ADRs, which will be identified, categorized, and compared between the intervention and control cohorts. The exploratory outcome measures of this study are to compare the incidence and severity of acute rejections, infections, graft function, graft loss, and death between research cohorts and measure the association between medication safety issues and these events. Additional data that will be gathered includes sociodemographics, health literacy, depression, and support. Conclusions: With this report we describe the study design, methods, and outcome measures that will be utilized in the ongoing TRANSAFE Rx clinical trial. Trial Registration: ClinicalTrials.gov NCT03247322: https://clinicaltrials.gov/ct2/show/NCT03247322 (Archived by WebCite at http://www.webcitation.org/6xcSUnuzW) [JMIR Res Protoc 2018;7(3):e59]

tudy objective Induction immunosuppression significantly improves graft outcomes following kidney transplantation, but protocols vary among transplant centers due to the lack of data identifying an optimal induction agent. The objective of this study was to assess the effectiveness of an evidence-based protocol change in induction therapy in adult kidney transplant recipients. Design Retrospective cohort study. Setting Large tertiary care academic medical center. Patients A total of 349 patients transplanted between August 2011 and December 2013 were included in the study. A protocol revision in 2012 reserved the use of lymphocyte-depleting induction therapy to a select group of traditionally high-risk patients based on findings of previous randomized, controlled trial performed at this center. Measurements and Main Results The primary outcome was biopsy proven acute rejection and graft loss. The use of non-depleting induction therapy increased significantly after the protocol revision, with no significant differences in rejection or infection rates identified between protocols. When comparing graft survival between the protocol cohorts, there was no significant difference. A cost-minimization analysis indicated that the revised protocol was associated with considerable medication cost savings. Conclusion A protocol targeting the use of lymphocyte-depleting induction to a select group of high-risk recipients appears to have equivalent efficacy and safety and is less costly compared with a more traditional induction protocol. This article is protected by copyright. All rights reserved.

Background This study evaluated the impact of body mass index (BMI) and patient functional status on the risk for surgical complications after kidney transplant. Methods This retrospective cohort study of adult kidney transplant recipients grouped patients by baseline Karnofsky status (low function ≤ 70%) and further stratified by morbid obesity (BMI ≥ 35 kg/m2) to assess surgical complication risk. Results 736 patients were included with surgical complications occurring in 25%. Logistic regression analysis with interaction terms demonstrated that morbid obesity and low functional status conditionally impact risk with an OR of 2.8 [95% CI (1.1–7.3)]. Within the functional status cohort, BMI ≥35 kg/m2 was associated with increased risk of surgical complication, superficial wound infection, and DGF. Independent predictors for surgical complications included diabetes and morbid obesity with low functional status. There was no significant difference in graft loss or death across the cohorts. Conclusions While neither morbid obesity nor poor functional status alone predicts increased complications, the combined presence is associated with significant increase in risk for surgical complications after renal transplantation.

Background The incidence and impact of adverse drug events (ADEs) leading to hospitalization and as a predominant risk factor for late graft loss has not been studied in transplantation. Methods This was a longitudinal cohort study of adult kidney recipients transplanted between 2005 and 2010 and followed through 2013. There were 3 cohorts: no readmissions, readmissions not due to an adverse drug event, and adverse drug events contributing to readmissions. The rationale of the adverse drug events contribution to the readmission was categorized in terms of probability, preventability, and severity. Results A total of 837 patients with 963 hospital readmissions were included; 47.9% had at least one hospital readmission and 65.0% of readmissions were deemed as having an ADE contribute. The predominant causes of readmissions related to ADEs included non-opportunistic infections (39.6%), opportunistic infections (10.5%), rejection (18.1%), and acute kidney injury (11.8%). Over time, readmissions due to under-immunosuppression (rejection) significantly decreased (−1.6% per year), while those due to over-immunosuppression (infection, cancer, or cytopenias) significantly increased (2.1% increase per year [difference 3.7%, P = .026]). Delayed graft function, rejection, creatinine, graft loss, and death were all significantly greater in those with an ADE that contributed to a readmission compared the other two cohorts (P Conclusion These results demonstrate that ADEs may be associated with a significant increase in the risk of hospital readmission after kidney transplant and subsequent graft loss.

Mobile health (mHealth) technology encompasses a wide range of potential clinical tools, with end-users ranging from the individual patient to national healthcare systems. This chapter focuses on mHealth with the patient as the end-user. It describes mHealth applications studied within solid organ transplant, as well as applications that have been used in non-transplant patients with chronic diseases common in transplant. It also provides an overview of fundamental necessities for successful mHealth systems and provides a roadmap to addressing current barriers to widespread study and implementation of mHealth.

Background There is limited data analyzing the pharmacokinetic (PK) and pharmacodynamic (PD) properties of everolimus (EVR) between African Americans and Caucasians. The purpose of this study was to determine and compare the EVR PKs and concentration-associated efficacy and toxicity in African American and Caucasian adult kidney transplant recipients. Methods This was a retrospective PK and PD analysis of all patients who received EVR at the Medical University of South Carolina Transplant Center between 2006 and 2012. Results Forty-three patients received EVR (22 African Americans, 21 Caucasians). Baseline demographics, immunosuppression, and immunologic risk were similar between races, except for preexisting hypertension, deceased donor type, and cold ischemic time, which were higher in African American patients. PK analysis revealed that African American patients received higher initial EVR doses (2.1 ± 0.8 versus 1.6 ± 0.6 mg/d, P = 0.036), leading to higher early EVR concentrations (EVR >6 ng/mL during the first 60 days: 36% versus 10%, P = 0.037). Efficacy analysis demonstrated similar EVR effects on acute rejection rates (9% versus 10%, P = 0.961), chronic allograft changes (18% versus 14%, P = 0.729), and renal function, with both groups having improved creatinine clearance with EVR therapy (ΔeGFR: 27 versus 12 mL·min·1.73 m). Toxicity analysis demonstrated that African American patients had a trend toward higher rates of EVR discontinuation (46% versus 19%, P = 0.065) and significantly more diarrhea/gastrointestinal intolerance (73% versus 38%, P = 0.022). Conclusions These results demonstrate EVR therapy is effective at preventing rejection and improving graft function in both African American and Caucasian adult renal transplant patients. Conflicting with previous mammalian target of rapamycin PK/PD analyses in African American patients, this study cohort demonstrated higher early EVR levels in the African American patients.

Background/Aims: There are no published studies assessing the safety and efficacy of thiazides as antihypertensives in kidney transplantation (KTX). Methods: This was a longitudinal retrospective cohort study conducted in adult KTX recipients. Patients were grouped based on receiving thiazides following KTX. Safety and efficacy comparisons were made between thiazide recipients and unexposed patients, as well as change in blood pressure (BP) within thiazide patients. Results: 1,093 patients were included (thiazide group: 108, unexposed group: 985). Mean follow-up was 7.3 ± 4.5 years. Thiazide recipients were older (53 ± 11 vs. 48 ± 13 years, p < 0.001) and more likely to be female (52 vs. 41%, p = 0.023) and have pre-KTX hypertension (97 vs. 88%, p = 0.004) or diabetes (36 vs. 27%, p = 0.035). After controlling for baseline differences, safety analysis revealed thiazide recipients were not more likely to be readmitted to the hospital, but were at higher risk to develop hyperkalemia (56 vs. 38%, p < 0.001) or hypokalemia (28 vs. 18%, p = 0.010), with similar rates of hypotension, decreased estimated glomerular filtration rate, graft loss and death. Efficacy analysis demonstrated systolic (147 ± 17 to 139 ± 18 mm Hg, p < 0.001) and diastolic (79 ± 9 to 77 ± 11 mm Hg, p < 0.001) BPs were significantly reduced after thiazide initiation. Compared to unexposed patients, thiazide recipients had higher mean BPs during the entire follow-up (142/78 vs. 136/77, p < 0.001), with similar BPs while on thiazides and comparable rates of goal BPs (Conclusions: In KTX, based on long-term outcomes, thiazides appear to be safe and effective antihypertensives; in the short-term, thiazides may increase the risk of developing potassium disturbances.

Study objective Drug-related problems (DRPs) are associated with increased rates of infection, rejection, and graft loss in kidney transplant recipients. This study aimed to develop a model to predict which patients are at highest risk of DRPs to streamline pharmacists' workflow in a chronic kidney transplant clinic. Design Prospective observational study. Setting Chronic kidney transplant clinic at a large, tertiary care, academic hospital. Patients Two hundred thirty-seven adults seen in the kidney transplant clinic between September 16, 2015, and November 30, 2015, who were at least 90 days posttransplantation at the time of their clinic visit. Measurements and main results Prospective data detailing DRPs and a survey assessing baseline characteristics and patient-related outcomes were used to generate a predictive model to identify patients at risk of having six or more DRPs; the cutoff of six DRPs provided a threshold for identifying a subset of high-risk patients on whom the transplant pharmacists could focus their efforts. DRPs were categorized as nonadherence, overdosing or underdosing, duplication of therapy, preventable adverse drug reaction, missing medication, erroneous medication, conflicting provider information, undermonitoring or lack of monitoring, and wrong medication received. In total, 865 unique DRPs were identified, and the most common were erroneous medication, missing medication, and nonadherence, accounting for 38%, 21%, and 16% of the DRPs, respectively. A nine-variable model with a sensitivity of 62.5% and specificity of 66.7% (area under the receiver operating characteristic curve of 0.720) was developed to identify patients at risk of having six or more DRPs. The model included the following variables: age, Medicaid for prescription insurance, current employment status, medication affordability, difficulty or lack of difficulty obtaining medications from the pharmacy, negative impact of medications on quality of life, medication nonadherence, poor rating of current health status, and moderate or poor medication understanding. Conclusion These results demonstrated that a straightforward, 5-minute survey completed by renal transplant recipients prior to their clinic visit may be capable of effectively determining those at risk of having six or more DRPs, potentially allowing use as a screening tool for transplant pharmacists' workflow prioritization. External validation is needed before this tool can be used in the outpatient setting.

Background: Non-adherence to medication is a well-studied and known cause of late allograft loss, but it is difficult to measure and prospectively monitor. The aim of this study was to assess if appointment non-adherence was correlated with medication non-adherence and a predictor of graft outcomes. Methods: This was a longitudinal cohort study that used the National United States Renal Data System and veterans affairs health records data with time-to-event analyses conducted to assess the impact on graft and patient survival. Results: The number of transplants that were included in the analysis was 4,646 (3,656 with complete records); 14.6% of patients had an appointment no show rate of ≥12% (non-adherence). Appointment and medication non-adherence were highly correlated and both were significant independent predictors of outcomes. Those with appointment non-adherence had 1.5 times the risk of acute rejection (22.0 vs. 14.7%, p < 0.0001) and a 65% higher risk of graft loss (adjusted hazards ratio (aHR) 1.65, 95% CI 1.38-1.97, p < 0.0001). There was a significant interaction between appointment and medication non-adherence; those with appointment and medication non-adherence were at very high risk of graft loss (aHR 4.18, 95% CI 3.39-5.15, p < 0.0001), compared to those with only appointment non-adherence (aHR 1.39, 95% CI 0.97-2.01, p = 0.0766) or only medication non-adherence (aHR 2.44, 95% CI 2.11-2.81, p < 0.0001). Conclusion: These results demonstrate that non-adherence to health care appointments is a significant and independent risk factor for graft loss.

Context: There is evidence that depression after liver transplant (LTX) is associated with increased morbidity and mortality; however, the effect of depression treatment on LTX outcomes has not been well established. Objective/Setting/Design: This single-center, longitudinal cohort study aimed to determine whether depression treatment influences outcomes after LTX. Depression diagnosis was based on medical history and documentation from psychosocial providers. Patients/Intervention/Main Outcome Measures: Patients were studied from October 2010 to June 2013 and separated into 3 groups for analysis: no depression, adequately treated depression, and inadequately treated depression. Adequacy of depression treatment was determined using the Antidepressant Treatment History Form. Results: Of the 161 patients included in the analysis, 103 did not have depression, 24 had adequately treated depression, and 34 had inadequately treated depression. Baseline demographics were similar between the groups. Patients with inadequately treated depression had significantly more encounters with a health-care provider ( P = .03). Graft loss tended to be higher in these patients (27% in the inadequately treated group, 17% in the adequately treated, and 14% in the no depression group, P = .25). The adequately treated group was more likely than the inadequately treated group to be on antidepressants at 30 days post-LTX ( P = .001). The inadequately treated group was more likely to be on a sleep aid 30 days post-LTX ( P = .01). Conclusion: Inadequately treated depression led to increased health-care resource utilization. Patients with adequately treated depression had similar outcomes as those with no depression. Use of sleep aids early post-LTX may be a surrogate indicator of inadequately treated depression.

The ongoing quandary in kidney transplantation is discovering methods to prolong graft survival. To achieve this, there is a search for optimal methods to use immunosuppressive therapy, where rejection and chronic graft damage is minimized without causing an increased risk of infections, malignancy, or toxicities. The purpose of this review was to discuss the limitations of current immunosuppressant drug monitoring as well as the clinical application of novel methods of monitoring both immunosuppressants and the immune reaction within the allograft.

Summary African-Americans (AA) have higher acute rejection rates and poorer long-term graft survival rates when compared with non-AA. It is yet to be demonstrated that the type of induction therapy modifies outcomes in this ‘high-risk’ population. This retrospective analysis compares the efficacy of induction therapy [antilymphocyte antibodies (ALA) versus interleukin-2 receptor antagonists (IL-2RA)] in the AA population. Some 189 AAs were included. There was no difference in acute rejection at one year between the groups (ALA (12%) or IL-2RA (12%), P = 0.89). Type of induction therapy had no significant effect on death-censored (P = 0.61) or uncensored graft survival (P = 0.32). There was no difference between CMV or BK virus infections between the groups (P = 0.14 and 0.94 respectively). Type of induction therapy does not appear to affect acute rejection rates or long-term graft survival in low-risk AA kidney transplant recipients.

Objective To determine if a pharmacist-executed comprehensive chart review could serve as sufficient substitution for direct participation during outpatient clinic visits in the postdischarge follow-up treatment of kidney transplant recipients. Design Retrospective, longitudinal, cross-sectional study. Setting Acute and chronic transplant clinics at the Medical University of South Carolina, Charleston, SC. Participants 219 individual kidney transplant recipients. Main outcome measures Effectiveness of chart review assessments (with written notes) as compared with in-clinic assessments (with verbal communication with transplant providers followed by documentation by pharmacists). An independent transplant provider graded pharmacist recommendations by severity. All recommendations were compared with the provider's plan to determine if the recommendations were incorporated. Results During the 3-month study period, 170 pharmacist chart reviews were written and 175 clinic visits involved direct pharmacist participation. Providers accepted a greater percentage of recommendations that were delivered directly compared with recommendations presented via a note in the patient folder following chart review (92% vs. 28%, respectively; P Conclusion The results of this study suggest that comprehensive chart review by pharmacists prior to patient clinic visits may not be as effective as in-person consultation in communicating recommendations to providers. Further research is needed in similar clinic settings.

OIs present significant risks to patients following solid organ transplantation. The purpose of this study was to identify risk factors for the development of OIs after kidney transplantation in pediatric patients and to evaluate the impact of OIs on outcomes in this patient population. A single-center retrospective longitudinal cohort analysis including pediatric patients 21 yr of age or younger transplanted from July 1999 to June 2013 at an academic medical center was conducted. Patients were excluded if they received multi-organ transplant. A total of 175 patients were included in the study. Patients who developed OIs were more likely to be female and younger at the time of transplant. A six-factor risk model for OI development was developed. Death, disease recurrence, and PTLD development were similar between groups but trended toward increased incidence in the OI group. Incidence of rejection was significantly higher in the OI group (p = 0.04). Patients who developed OIs had several important risk factors, including younger age, EBV-negative serostatus, CMV donor (+)/recipient (-), biopsy-proven acute rejection, ANC1000, MMF dose500 mg/m(2), and any infection. Incidence of rejection was higher in the OI group, but rate of graft loss was not statistically different.

Studies have continued to evaluate risk factors associated with post-transplant non-adherence in pediatric patients. However, many of these studies fail to evaluate how risk factors can be utilized to predict MNA. The aims of this study were to (i) determine salient risk factors associated with MNA to develop an adequate predictive risk model and (ii) assess transplant outcomes based on the presence of MNA in a large, diverse cohort of pediatric KTX recipients. One hundred and seventy-five solitary pediatric KTX recipients transplanted from 1999 to 2013 were included. AA, males, older patients, those who lived in urban environments, had legal issues, and lived shorter distances from the transplant center were more likely to have MNA. Using logistic regression, a parsimonious model applying nine risk factors together was developed for predicting MNA, demonstrating a PPV of 69% and a NPV of 81%. Patients with MNA had more than twice the risk of biopsy proven acute rejection, 1.6 times the risk of hospitalization, and 1.8 times the risk of graft loss. Utilization of a predictive model to determine risk of MNA after pediatric KTX may offer clinicians the ability to efficiently and effectively monitor MNA following transplant.

Despite proven efficacy of prolonged cytomegalovirus (CMV) prophylaxis using valganciclovir 900 mg/day, some centers use 450 mg/day due to reported success and cost savings. This multicenter, retrospective study compared the efficacy and safety of 6 months of low-dose versus high-dose valganciclovir prophylaxis in high-risk, donor-positive/recipient-negative, renal transplant recipients (RTR).Two hundred thirty-seven high-risk RTR (low-dose group = valganciclovir 450 mg/day [n = 130]; high-dose group = valganciclovir 900 mg/day [n = s7]) were evaluated for 1-year CMV disease prevalence. Breakthrough CMV, resistant CMV, biopsy-proven acute rejection (BPAR), graft loss, opportunistic infections (OI), new-onset diabetes after transplantation (NODAT), premature valganciclovir discontinuation, renal function and myelosuppression were also assessed.Patient demographics and transplant characteristics were comparable. Induction and maintenance immunosuppression were similar, except for more early steroid withdrawal in the high-dose group. Similar proportions of patients developed CMV disease (14.6% vs 24.3%; P = 0.068); however, controlling CMV risk factor differences through multivariate logistic regression revealed significantly lower CMV disease in the low-dose group (P = 0.02; odds ratio, 0.432, 95% confidence interval, 0.211-0.887). Breakthrough and resistant CMV occurred at similar frequencies. There was no difference in renal function or rates of biopsy-proven acute rejection, graft loss, opportunistic infections, or new-onset diabetes after transplantation. The high-dose group had significantly lower mean white blood cell counts at months 5 and 6; however, premature valganciclovir discontinuation rates were similar.Low-dose and high-dose valganciclovir regimens provide similar efficacy in preventing CMV disease in high-risk RTR, with a reduced incidence of leukopenia associated with the low-dose regimen and no difference in resistant CMV. Low-dose valganciclovir may provide a significant cost avoidance benefit.

Induction therapy with antilymphocyte biological agents is widely used after kidney transplantation, most commonly T lymphocyte‐depleting rabbit‐derived antithymocyte globulin (rATG) or an IL‐2 receptor antagonist (IL2RA). Early randomized trials showed that rATG or IL2RA induction reduces early acute rejection, prompting recommendations by Kidney Disease Improving Global Outcomes that IL2RA induction be used routinely in first‐line therapy after kidney transplantation, with lymphocyte‐depleting induction reserved for high‐risk cases. These studies, however, mainly used outdated maintenance regimens. No large randomized trial has examined the effect of IL2RA or rATG induction versus no induction in patients receiving tacrolimus, mycophenolic acid and steroids. With this triple maintenance therapy, the addition of induction may achieve an absolute risk reduction for acute rejection of only 1–4% in standard‐risk patients without improving graft or patient survival. In contrast, rATG induction lowers the relative risk of acute rejection by almost 50% versus IL2RA in patients with high immunological risk. These recent data raise questions about the need for IL2RA in kidney transplantation, as it may no longer be beneficial in standard‐risk transplantation and may be inferior to rATG in high‐risk situations. Updated evidence‐based guidelines are necessary to support clinicians deciding whether and what induction therapy is required for their transplant patients today., The authors discuss the role of induction therapy in contemporary kidney transplantation and question the need for interleukin‐2 receptor monoclonal antibodies.

Background With the advent of effective antivirals against cytomegalovirus (CMV), use of CMV hyperimmune globulin has decreased. Although antiviral prophylaxis in patients at high risk for CMV is effective, many patients still have late infection, never developing antibodies sufficient to achieve immunity. Utilizing a combination of antiviral and CMV immunoglobulin G may allow patients to achieve immunity and decrease late CMV infections. Methods This was a prospective randomized, open-label, pilot study comparing valganciclovir (VGCV) prophylaxis for 200 days vs VGCV for 100 days followed by CMV HIG in abdominal transplant recipients at high risk for CMV. The primary outcome was a comparison of late CMV disease. Results Forty patients were randomized to VGCV for 200 days (n = 20) or VGCV for 100 days followed by 3 doses of monthly CMV HIG (n = 20). Numerically, more overall CMV infections occurred in the CMV HIG group (45 vs 20%, P = 0.09). No differences in overall CMV infections or late CMV disease were seen between groups (20% vs 15%, P = 1.00 and 0 vs 0, P = 1.00). All CMV disease occurred within 200 days, with 63% occurring while patients were on VGCV. No differences were found in toxicities, graft function, or rejection between groups. Patients with CMV infection at any time had a higher body weight than those who did not have an infection (82 vs 95 kg, P = .049). Conclusion Use of CMV HIG sequentially with prophylaxis may be an effective and affordable prophylactic regimen in abdominal transplant recipients at high risk for CMV, and warrants larger prospective study. Increased monitoring for patients with obesity may be warranted. This article is protected by copyright. All rights reserved.