G. Carl Huber (1865-1934): A Michigan Pioneer in Peripheral Nerve Injury and Regeneration.

The treatment of peripheral nerve injuries has seen tremendous innovations over the past century. Dr Gotthelf Carl Huber, an American immigrant and early experimental pioneer in the field of peripheral nerve injury, created a foundation of scientific knowledge for these advancements. At the beginning of his career, Huber published novel work in peripheral nerve injury, supporting the concept of Wallerian degeneration and demonstrating the use of nerve grafting for repair. As his scientific career evolved into other research areas at the University of Michigan, Huber's impact extended far beyond just the study of peripheral nerve injury. Because of the external forces of the First World War, Dr Huber's focus returned to translational projects concentrated on the treatment of neuromas and war time peripheral nerve injuries. Huber's scientific impact in the field of peripheral nerve injury and repair came as a result of his incredible work ethic, mentorship, and tremendous leadership qualities; through this, his work still influences clinical practice today, a century later.

Review and Evaluation of mHealth Apps in Solid Organ Transplantation: Past, Present, and Future.

With the rapid and widespread expansion of smartphone availability and usage, mobile health (mHealth) has become a viable multipurpose treatment medium for the US healthcare system. Methods: The purpose of this review is to identify posttransplant mHealth applications that support patient self-management or a patient-provider relationship and aim to improve clinical outcomes. The interventions were then analyzed and evaluated to identify current gaps and future needs of mHealth apps in solid organ transplantation. Results: The authors found a nearly universal dichotomy between perceived utility and sustained use, with most studies demonstrating significant attrition during the course of the intervention. In addition, interoperability continues to be a challenge. Conclusions: The authors present potential methods for mitigating the identified barriers and gaps in mHealth apps for solid organ transplant recipients.

Early Assessment of National Kidney Allocation Policy Change.

BACKGROUND: The new kidney allocation changes with elimination of donor service areas (DSAs) and Organ Procurement and Transplantation Network regions were initiated to improve equity in organ allocation. The aim of this evaluation was to determine the operational, financial, and recipient-related effect of the new allocation system on a large rural transplantation program. STUDY DESIGN: A retrospective, cross-sectional analysis of organ offers, allograft outcomes, and attributed costs in a comparative time cohort, before (December 16, 2020 to March 14, 2021) and after (March 15, 2021 to June 13, 2021) the allocation change was performed. Outcomes were limited to adult, solitary, deceased donor kidney transplantations. RESULTS: We received 198,881 organ offers from 3,886 organ donors at our transplantation center from December 16, 2020 to June 31, 2021: 87,643 (1,792 organ donors) before the change and 111,238 (2094 organ donors) after the change, for a difference of +23,595 more offers (+302 organ donors). This resulted in 6.5 more organs transplanted vs a predicted loss of 4.9 per month. Local organ offers dropped from 70% to 23%. There was a statistically significantly increase in donor terminal serum creatinine (1.2 ± 0.86 mg/dL vs 2.2 ± 2.3 mg/dL, p < 0.001), kidney donor profile index (KDPI) (39 ± 20 vs 48 ± 22, p = 0.017), cold ischemia time (16 ± 7 hours vs 21 ± 6 hours, p < 0.001), and delayed graft function rates (23% vs 40%, p = 0.020). CONCLUSION: The new kidney allocation policy has led to an increase in KDPI of donors with longer cold ischemia time, leading to higher delayed graft function rates. This has resulted in increasing logistical and financial burdens on the system. Implementing large-scale changes in allocation based predominantly on predictive modeling needs to be intensely reassessed during a longer follow up.

A Critical Analysis of the Specific Pharmacist Interventions and Risk Assessments During the 12-Month TRANSAFE Rx Randomized Controlled Trial.

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.

Knowledge of neonatal brachial plexus palsy among medical professionals in North America.

PURPOSE: Early referral of neonatal brachial plexus palsy (NBPP) patients to multidisciplinary clinics is critical for timely diagnosis, treatment, and improved functional outcomes. In Saudi Arabia, inadequate knowledge regarding NBPP is a reason for delayed referral. We aimed to evaluate the knowledge of North American healthcare providers (HCPs) regarding the diagnosis, management, and prognosis of NBPP. METHODS: A 12-question survey regarding NBPP was distributed via electronic and paper formats to North American providers from various referring and treating specialties. NBPP knowledge was compared between Saudi Arabian vs. North American providers, referring vs. treating specialties, academic vs. community hospitals, and providers with self-reported confidence vs. nonconfidence in NBPP knowledge. RESULTS: Of the 273 surveys collected, 45% were from referring providers and 55% were from treating providers. Saudi Arabian and North American HCPs demonstrated similar NBPP knowledge except for potential etiologies for NBPP and surgery timing. In North America, referring and treating providers had similar overall knowledge of NBPP but lacked familiarity with its natural history. A knowledge gap existed between academic and community hospitals regarding timing of referral/initiation of physical/occupational therapy (PT/OT) and Horner's syndrome. Providers with self-reported confidence in treating NBPP had greater knowledge of types of NBPP and timing for PT/OT initiation. CONCLUSIONS: Overall, North American providers demonstrated adequate knowledge of NBPP. However, both eastern and western physicians remain overly optimistic in believing that most infants recover spontaneously. This study revealed a unique and universal knowledge gap in NBPP diagnosis, referral, and management worldwide. Continuous efforts to increase NBPP knowledge are indicated.

Significant hospitalization cost savings to the payer with a pharmacist-led mobile health intervention to improve medication safety in kidney transplant recipients.

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.

Pharmacist-Led Mobile Health Intervention and Transplant Medication Safety: A Randomized Controlled Clinical Trial.

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<0.001) and a significantly lower incidence risk of Grade 3 or higher adverse events (incident risk ratio, 0.55, 95% confidence interval, 0.30 to 0.99; P=0.05). For the secondary outcome of hospitalizations, the intervention arm demonstrated significantly lower rates of hospitalizations (incident risk ratio, 0.46; 95% confidence interval, 0.27 to 0.77; P=0.005). CONCLUSIONS: We demonstrated a significant reduction in medication errors, adverse events, and hospitalizations using a pharmacist-led, mobile health-based intervention.

Impact of a pharmacist-led, mHealth-based intervention on tacrolimus trough variability in kidney transplant recipients: A report from the TRANSAFE Rx randomized controlled trial.

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.

Etiologies and Outcomes Associated With Tacrolimus Levels Out of a Typical Range That Lead to High Variability in Kidney Transplant Recipients.

BACKGROUND: High tacrolimus intrapatient variability (tac IPV) is associated with poor outcomes in kidney transplantation, including rejection, donor-specific antibodies, and graft loss. A common cause of high tac IPV is related to patient nonadherence, but this is yet to be conclusively demonstrated. METHODS: This was a longitudinal cohort study comprising adult kidney recipients, who received transplants between 2015 and 2017, with follow-ups through February 2020. The goal of this study was to identify the most common etiologies of tac levels outside the typical range, which lead to high tac IPV, and assess the etiology-specific associations between high tac IPV and graft outcomes. Multivariate Cox regression was used to assess time-to-event analyses. RESULTS: In total, 537 adult kidney recipients were included; 145 (27%) were identified as having a high tac IPV (>40%) 3-102 months post-transplant. Common etiologies of tac levels significantly outside the standard goal range (6-12 ng/mL) leading to high tac IPV included patient nonadherence (20%), infections (19%), tac-related toxicities (17%), and undocumented issues (27%). In multivariable Cox modeling, those with high tac IPV because of nonadherence had a 3.5 times higher risk of late acute rejection (P = 0.019) and 2.2 times higher risk of late graft loss (P = 0.044). No other etiologies in the typical tac level range were significantly associated with either acute rejection or graft loss. CONCLUSIONS: Although high tac IPV has many causes, only high tac IPV caused by nonadherence is consistently associated with poor allograft outcomes.

Maintaining Equity and Access: Successful Implementation of a Virtual Kidney Transplantation Evaluation.

BACKGROUND: Maintaining access to kidney transplantation during a pandemic is a challenge, particularly for centers that serve a large rural and minority patient population with an additional burden of travel. The aim of this article was to describe our experience with the rollout and use of a virtual pretransplantation evaluation platform to facilitate ongoing transplant waitlisting during the early peak of the COVID-19 pandemic. STUDY DESIGN: This is a retrospective analysis of the process improvement project implemented to continue the evaluation of potential kidney transplantation candidates and ensure waitlist placement during the COVID-19 pandemic. Operational metrics include transplantation volume per month, referral volume per month, pretransplantation patients halted before completing an evaluation per month, evaluations completed per month, and patients waitlisted per month. RESULTS: Between April and September 2020, a total of 1,258 patients completed an evaluation. Two hundred and forty-seven patients were halted during this time period before completing a full evaluation. One hundred and fifty-two patients were presented at selection and 113 were placed on the waitlist. In addition, the number of patients in the active referral phase was able to be reduced by 46%. More evaluations were completed within the virtual platform (n = 930 vs n = 880), yielding similar additions to the waitlist in 2020 (n = 282) vs 2019 (n = 308) despite the COVID-19 pandemic. CONCLUSIONS: The virtual platform allowed continued maintenance of a large kidney transplantation program despite the inability to have in-person visits. The value of this platform will likely transform our approach to the pretransplantation process and provides an additional valuable method to improve patient equity and access to transplantation.

Patterns of emergency department utilization between transplant and non-transplant centers and impact on clinical outcomes in kidney recipients.

There is a high rate of Emergency Department (ED) utilization in kidney recipients post-transplant; ED visits are associated with readmission rates and lower survival rates. However, utilization within and outside transplant centers may lead to different outcomes. The objective was to analyze ED utilization patterns at transplant and non-transplant centers as well as common etiologies of ED visits and correlation with hospitalization, graft, and patient outcomes. This was a longitudinal, retrospective, single-center cohort study in kidney transplant recipients evaluating ED utilization. Comparator groups were determined by ED location, time from transplant, and disposition/readmission from ED visit. 1,106 kidney recipients were included in the study. ED utilization dropped at the transplant center after the 1st year (P < .001), while remaining at a similar rate at non-transplant centers (0.22 vs 1.06 VPPY). Infection and allograft complications were the most common causes of ED visits. In multivariable Cox modeling, an ED visit due to allograft complication at a non-transplant center >1 year post-transplant was associated with higher risk for graft loss and death (aHR 2.93 and aHR 1.75, P < .0001). The results of this study demonstrate an increased risk of graft loss among patients who utilize non-transplant center emergency departments. Improved communication and coordination between transplant centers and non-transplant centers may contribute to better long-term outcomes.

Exploratory Analysis of the Impact of an mHealth Medication Adherence Intervention on Tacrolimus Trough Concentration Variability: Post Hoc Results of a Randomized Controlled Trial.

BACKGROUND: Medication nonadherence is a leading cause of late allograft loss in kidney transplantation (KT). Tacrolimus trough coefficient of variation (CV), measured using the coefficient of variation, is strongly correlated with acute rejection, graft function, and graft loss. OBJECTIVE: The objective of this study was to determine if this mobile health (mHealth) intervention aimed at improving medication adherence in a nonadherent KT population would affect high intrapatient tacrolimus variability. METHODS: A 6-month, prospective, parallel-arm, randomized controlled clinical trial was conducted to determine the effects of an mHealth intervention on tacrolimus CV. Intervention arm participants utilized an electronic medication tray and an mHealth app to monitor home-based adherence. Tailored motivational reinforcement messages were delivered to promote competence for adherence. Tacrolimus CV was measured using a 12-month rolling average, assessed at monthly intervals (6-month intervention period and 6 months after completion of the study); 80 were included, 40 in each arm. RESULTS: At baseline, tacrolimus CV was similar between arms (37% ± 15% intervention, 37% ± 13% control, P = 0.894). Patients randomized to the intervention had a significant reduction in mean 12-month tacrolimus CVs (P = 0.046) and a significant improvement in the proportion achieving low tacrolimus CV (tacrolimus CV < 40%; P = 0.001), as compared with the control arm. CONCLUSION AND RELEVANCE: High tacrolimus CV is a risk factor for acute rejection and graft loss; these results offer the potential promise of improved medication adherence and clinical outcomes through the use of innovative technology.

A comprehensive review of the impact of tacrolimus intrapatient variability on clinical outcomes in kidney transplantation.

Tacrolimus (Tac) is widely used to prevent rejection and graft loss in solid organ transplantation. A limiting characteristic of Tac is the high intra and interpatient variability associated with its use. Routine therapeutic drug monitoring (TDM) is necessary to facilitate Tac management and to avoid undesirable clinical outcomes. However, whole blood trough concentrations commonly utilized in TDM are not strong predictors of the detrimental clinical outcomes of interest. Recently, researchers have focused on Tac intrapatient variability (Tac IPV) as a novel marker to better assess patient risk. Higher Tac IPV has been associated with a number of mechanisms leading to shortened graft survival. Medication nonadherence (MNA) is considered to be the primary determinant of high Tac IPV and perhaps the most modifiable risk factor. An understanding of the methodology behind Tac IPV is imperative to its recognition as an important prognostic measure and integration into clinical practice. Therapeutic interventions targeting MNA and reducing Tac IPV are crucial to improving long-term graft survival.

Preliminary assessment of safety and adherence to a once-daily immunosuppression regimen in kidney transplantation: Results of a randomized controlled pilot study.

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.

Assessment of magnetic resonance imaging derived fat fraction as a sensitive and reliable predictor of myosteatosis in liver transplant recipients.

BACKGROUND: Measures of skeletal muscle abnormalities are rapidly emerging as independent predictors of outcomes after liver transplantation (LT). We describe a simple, novel assessment of myosteatosis acquired prior to liver transplantation using Magnetic Resonance Imaging (MRI) derived fat fraction. METHODS: A retrospective longitudinal cohort study included clinical and biochemical data from patients who underwent liver transplantation at our institution between Feb 2008 and Aug 2014. Patients transplanted for a diagnosis of hepatocellular carcinoma were excluded from the study. The fat fraction of erector spinae muscles was estimated using MRI at the level where muscle volume was highest, with myosteatosis defined at a cut-off value of 0.8. RESULTS: 180 patients were included. At baseline, those with myosteatosis were, on average, older, more likely to be female, and more likely to receive a multi-organ transplant (p < 0.05). Patients with pre-transplant myosteatosis, as delineated by MRI derived fat fraction, also had increased length of hospital stay. CONCLUSION: This preliminary study suggests myosteatosis, as measured by fat fraction on MRI prior to LT, may be associated with increased graft loss and mortality after transplant.

Long-standing diabetes mellitus and pancreas transplantation: An avenue to increase utilization of an ideal treatment modality.

BACKGROUND: Diabetes mellitus (DM) is associated with increased post-operative complications in various surgeries. Little data exist regarding the impact of long-standing DM (>25 years) on outcomes in pancreas transplantation (PTX). The objectives of our study were to determine if long-standing pre-transplant DM (>25 years) was associated with inferior outcomes following PTX. METHODS: Using a 13-year (April, 2000-May, 2012) retrospective analysis, we examined demographic and transplant factors, complications, and outcomes in patients without (Group A) and with (Group B) long-standing (>25 years) pre-PTX DM. RESULTS: Mean follow-up was 4.2 years. Of 214 consecutive PTX performed, 137 (105 simultaneous PTX (SPK), 25 PTX after kidney (PAK), 7 PTX alone (PTA)) had pre-PTX duration of DM recorded, including 65 in Group A and 72 in Group B. There were no differences between cohorts with respect to demographics. There were no differences in post-PTX surgical/medical complications. There were no differences in outcomes between cohorts (ie, rejection, graft loss or death). CONCLUSIONS: This large-scale analysis demonstrated that PTX can be performed in patients with long-standing DM with excellent patient and graft outcomes. Long-standing DM did not lead to an increased post-PTX infections or complications. Our study suggests that duration of DM should not impact PTX candidacy.

Using informatics and mobile health to improve medication safety monitoring in kidney transplant recipients.

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.

"Smartphone Medication Adherence Saves Kidneys" for Kidney Transplantation Recipients: Protocol for a Randomized Controlled Trial.

BACKGROUND: Kidney transplant recipients' poor medication adherence and poor control of comorbidities, particularly hypertension, are risk factors for graft rejection, graft loss, and death. Few randomized controlled trials (RCTs) have been successful in improving sustained medication adherence and blood pressure control among kidney transplantation recipients. We provide rationale for an RCT evaluating a mobile health medical self-management system for kidney transplantation recipients called Smartphone Medication Adherence Saves Kidneys (SMASK). OBJECTIVE: Our objective is to determine whether SMASK is efficacious in improving medication adherence and sustaining blood pressure control among kidney transplantation recipients with uncontrolled hypertension and poor medication adherence compared to an enhanced standard care. METHODS: This two-arm, 6-month, phase II single-site efficacy RCT will involve 80 kidney transplantation recipients. Participants will be randomly assigned to the SMASK intervention arm or control arm. SMASK includes multilevel components: automated reminders from an electronic medication tray; tailored text messages and motivational feedback, guided by the self-determination theory; and automated summary reports for providers. Evaluations will be conducted preintervention, at 3 and 6 months, and posttrial at 12 months. Specific aims are to test the hypotheses that compared to standard care, the SMASK cohort will demonstrate significantly improved changes at 3, 6, and 12 months in the primary outcome variables medication adherence (proportion with electronic monitor-derived score >0.90) and blood pressure control (proportion meeting and sustaining adherence to the Kidney Disease Improving Global Outcomes [KDIGO] guidelines for blood pressure control); the secondary outcome variables provider adherence to KDIGO guidelines, measured by timing of medication changes and changes in self-determination theory constructs; and the exploratory outcome variables estimated glomerular filtration rate, variability in calcineurin inhibitor trough levels, and proportion of patients meeting and sustaining the 24-hour ambulatory blood pressure below 130/80 mm Hg. After the 6-month evaluation, interviews with a random sample of SMASK subjects (n=20) and health care providers (n=3-5) will assess user reactions including acceptability, usability, and aids/barriers to sustainability. Data from the RCT and interviews will be triangulated to further refine and optimize SMASK and prepare for a multisite effectiveness RCT. RESULTS: The SMASK project received funding from National Institute of Diabetes and Digestive and Kidney Diseases in June 2016, obtained institutional review board approval in April 2016, and began data collection in July 2016. As of July 2018, we completed enrollment with a total of 80 participants. CONCLUSIONS: This study will provide data regarding the efficacy of SMASK to improve medication adherence and blood pressure control in a cohort of hypertensive kidney transplant recipients. An efficacious SMASK intervention will pave the way for a larger, multicenter, effectiveness RCT powered sufficiently to evaluate clinical events in a real-world setting and with the potential to demonstrate improved outcomes at lower cost than standard care. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13351.

Impact of Type 1 and Type 2 Diabetes Mellitus on Pancreas Transplant Outcomes.

OBJECTIVES: Pancreas transplant improves quality of life and survival of patients irrespective of pretransplant C-peptide levels. Our objectives were to examine complications and outcomes in patients without measureable C-peptide (insulin-dependent type 1 diabetes mellitus) and carefully selected patients with measurable C-peptide (insulin-dependent type 2 diabetes mellitus) after pancreas transplant. MATERIALS AND METHODS: We conducted a retrospective analysis to examine the demographic, transplant factors, complications, and outcomes in patients with nondetectable pretransplant C-peptide (insulin-dependent type 1 diabetes mellitus) and patients with detectable pretransplant C-peptide (insulin-dependent type 2 diabetes mellitus). RESULTS: Of 214 consecutive pancreas transplant procedures over a 12-year period, 112 had pretransplant C-peptide level testing (63 patients with type 1 and 49 with type 2 diabetes mellitus). Patients with type 1 disease were more likely to be female (P = .048), and patients with type 2 disease were more likely to be African American (P < .001) and have undergone previous pancreas transplant (P = .042). We observed no differences in donor factors or posttransplant factors (C-peptide after year 2, glucose, and hemoglobin A1C, except that patients with type 2 disease had more pancreatitis) (P = .036). There were no differences in posttransplant complications; however, patients with type 2 disease had significantly higher BK virus nephropathy (P = .006). There were no differences in outcomes between cohorts (rejection, graft loss, or death; P = not significant). CONCLUSIONS: Pancreas transplant can be performed with excellent and equivalent outcomes in patients with type 1 and carefully selected type 2 diabetes mellitus. Patients with type 2 disease are more likely to have posttransplant pancreatitis and BK virus nephropathy, affecting the net benefit for transplant.