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Pain, a common debilitating symptom among kidney transplant recipients (KTRs), is among the most common and undertreated symptoms after kidney transplantation.Characterize associations between gut microbiome features and pain interference before and after kidney transplantation.Longitudinal, repeated measures study of 19 living-donor kidney transplant recipients, collecting fecal specimens and pain interference data pretransplant and 3 months posttransplant.Participants were recruited at the Kidney Transplant Clinic at the University of Illinois HospitalHealth Sciences System.19 living fonor kidney transplant recipients. (need to remove this from ``design''.We assessed fecal microbial community structure with shotgun metagenomic sequencing; we used pain interference scores derived from the Patient-Reported Outcomes Measurement Information System-57.We measured a reduction in the Shannon diversity index in both groups after transplantation but observed no significant differences between groups at either time point. We did observe significant differences in fecal microbial Bray-Curtis similarity index among those reporting pain interference pretransplant versus no pain interference at 3-months posttransplant (R = .306, p = .022), and between pain interference groups posttransplant (R = .249, p = .041). Pairwise models showed significant differences between groups posttransplant in relative abundances of several taxa, including a 5-fold reduction in Akkermansia among those with pain interference and a higher relative abundance of taxa associated with chronic inflammation in those with pain interference posttransplant. Functional gene analysis identified two features that were significantly enriched in those with pain interference, including a peptide transport system gene.Gut microbiota community structure differs between groups with and without pain interference at 3 months after kidney transplantation. Several taxa involved in intestinal barrier integrity and chronic inflammation were associated with posttransplant pain.

This secondary analysis explored how the constructs of the health belief model affect influenza vaccine uptake in kidney transplant recipients (KTRs). In the parent study, a total of 180 KTRs were recruited at an organ transplant center in South Korea. A nonlinear path analysis using generalized structural equation modeling was performed. Previous influenza vaccination had a direct effect on their behavior, while cues to action alone did not directly affect their behavior. Perceived benefits played a key role as a mediator in improving influenza vaccine uptake in KTRs. This study highlights the need for health professionals to assess perceived benefits at the individual level and provide patient-centered interventions based on a consideration of theoretical mechanisms. As cues to action, recommendations for recipients’ first vaccination after kidney transplant should focus on changing patients’ perceptions of benefits by emphasizing the positive aspects of the influenza vaccine for immunosuppressed patients.

Patients with chronic kidney disease (CKD) frequently experience unpleasant symptoms. These can be gastrointestinal (constipation, nausea, vomiting and diarrhoea), psychological (anxiety and sadness), neurological (lightheadedness, headache and numbness), cardiopulmonary (shortness of breath and oedema), dermatological (pruritus and dry skin), painful (muscle cramps, chest pain and abdominal pain) or involve sexual dysfunction, sleep disorders and fatigue. These symptoms often occur in clusters, with one of them as the lead symptom and others as secondary symptoms. Uraemic toxins (also called uremic toxins) are often considered to be the main cause of CKD-associated symptom burden, but treatment of uraemia by dialysis often fails to resolve them and can engender additional symptoms. Indeed, symptoms can be exacerbated by comorbid conditions, pharmacotherapies, lifestyle and dietary regimens, kidney replacement therapy and ageing. Patients with kidney disease, including those who depend on dialysis or transplantation, should feel actively supported in their symptom management through the identification and targeting of unpleasant symptoms via a tailored palliative care approach. Such an approach may help minimize the burden and consequences of kidney disease, and lead to improved patient outcomes including health-related quality of life and better life participation.

Patient reports of moderate to severe pain are common across the spectrum of chronic kidney disease. The synergistic effects of comorbid depression and anxiety can lead to maladaptive coping responses to pain, namely pain catastrophizing and illness-related post-traumatic stress disorder. If underlying depression and anxiety and associated maladaptive coping responses are not treated, patients can experience an increased perception of pain, worsened disability, decreased quality of life, withdrawal from social activities, and increased morbidity and mortality. Meanwhile, interest in nonpharmacologic treatments for pain that targets coping as well as comorbid anxiety and depression has been increasing, particularly given the significant societal damage that has resulted from the opioid epidemic. Evidence-based, nonpharmacologic treatments have shown promise in treating pain in areas outside of nephrology. Currently, little is known about the effects of these treatments among adults with CKD, and particularly end-stage kidney disease, when chronic pain can become debilitating. In this review, we examine patient-centered concepts related to pain that have received little attention in the nephrology literature. We also describe emerging areas of research, including omics technologies for biomarker discovery and advanced symptom clustering methods for symptom phenotyping, which may be useful to future kidney disease research and treatment.

The development of ascites in patients with cirrhosis can cause numerous complications including abdominal discomfort, pain, respiratory distress, decreased mobility, diminished quality of life, and contributes to an increased mortality. Symptom self-monitoring that incorporates evidence-based treatments has been effective when used by patients with noncirrhotic chronic diseases. Guided by the theory of Self-Care of Chronic Illness, a self-monitoring guide was adapted from an existing validated tool. In the context of a pilot quality initiative, staff nurses educated patients with ascites and their caregivers, with the adapted symptom self-monitoring guide using a standardized process. Clinicians were surveyed regarding their satisfaction with the patient education pre- and post-implementation. Results indicated improved clinician satisfaction with the education provided to patients and their caregivers during the clinic visit. Implementation of self-monitoring may improve clinician and patient satisfaction and clinic workflows. Additional evaluation of the self-monitoring guide and its effect on patient satisfaction, impact on hospital admissions, and outpatient paracentesis is warranted.

Among breast cancer survivors, pain, fatigue, depression, anxiety, and sleep disturbance are common psychoneurological symptoms that cluster together. Inflammation-induced activation of the tryptophan-kynurenine metabolomic pathway may play an important role in these symptoms.This study investigated the relationship between the metabolites involved in the tryptophan-kynurenine pathway and psychoneurological symptoms among breast cancer survivors.Cross-sectional study.Participants were recruited at the oncology clinic at the University of Illinois HospitalHealth Sciences System.79 breast cancer survivors after major cancer treatment.We assessed psychoneurological symptoms with the PROMIS-29 and collected metabolites from fasting blood among breast cancer survivors after major cancer treatment, then analyzed four major metabolites involved in the tryptophankynurenine pathway (tryptophan, kynurenine, kynurenic acid, and quinolinic acid). Latent profile analysis identified subgroups based on the five psychoneurological symptoms. Mann-Whitney U tests and multivariable logistic regression compared targeted metabolites between subgroups.We identified two distinct symptom subgroups (low, 81%; high, 19%). Compared with participants in the low symptom subgroup, patients in the high symptom subgroup had higher BMI (p = .024) and were currently using antidepressants (p = .008). Using multivariable analysis, lower tryptophan levels (p = .019) and higher kynurenine/tryptophan ratio (p = .028) were associated with increased risk of being in the high symptom subgroup after adjusting for BMI and antidepressant status.The tryptophan-kynurenine pathway and impaired tryptophan availability may contribute to the development of psychoneurological symptoms.

Chronic kidney disease (CKD) confers a high burden of uremic symptoms that may be underrecognized, underdiagnosed, and undertreated. Unpleasant symptoms, such as CKD-associated pruritus and emotional/psychological distress, often occur within symptom clusters, and treating 1 symptom may potentially alleviate other symptoms in that cluster. The Living Well with Kidney Disease and Effective Symptom Management Consensus Conference convened health experts and leaders of kidney advocacy groups and kidney networks worldwide to discuss the effects of unpleasant symptoms related to CKD on the health and well-being of those affected, and to consider strategies for optimal symptom management. Optimizing symptom management is a cornerstone of conservative and preservative management which aim to prevent or delay dialysis initiation. In persons with kidney dysfunction requiring dialysis (KDRD), incremental transition to dialysis and home dialysis modalities offer personalized approaches. KDRD is proposed as the preferred term given the negative connotations of "failure" as a kidney descriptor, and the success stories in CKD journeys. Engaging persons with CKD to identify and prioritize their personal values and individual needs must be central to ensure their active participation in CKD management, including KDRD. Person-centered communication and care are required to ensure diversity, equity, and inclusion; education/awareness that considers the health literacy of persons with CKD; and shared decision-making among the person with CKD, care partners, and providers. By putting the needs of people with CKD, including effective symptom management, at the center of their treatment, CKD can be optimally treated in a way that aligns with their goals.

The co-occurrence of multiple psychoneurological symptoms, including pain, sleep disturbance, fatigue, depression, anxiety, and cognitive disturbance among adult cancer survivors led us to question which common biological mechanisms are shared among these conditions. Variances in tryptophan (Trp) levels and downstream metabolites of the kynurenine (Kyn) metabolic pathway are known to affect immune response and psychoneurological symptoms. The objective of this systematic review was to help us (a) better understand the role of the Kyn pathway in psychoneurological symptoms among adult cancer survivors and (b) identify common significant biomarkers across psychoneurological symptoms as a guide for future research. Some evidence has shown that decreased Trp levels and increased Kyn, Trp/Kyn ratio, and kynurenic acid/Trp ratio in parallel with immune activation are correlated with some psychoneurological symptoms among people undergoing cancer treatment, although discrepancies exist between studies. Kyn pathway activation could also be associated with psychoneurological symptoms among adult cancer survivors, but further research is needed to confirm its exact etiological role with respect to psychoneurological symptoms.

Purpose of review Chronic kidney disease-associated-pruritus (CKD-aP) is a common symptom in patients with end-stage kidney disease (ESKD) undergoing dialysis. CKD-aP typically occurs alongside other debilitating symptoms and may comprise so-called ‘symptom clusters’ which have synergistic effects that adversely impact patient health-related quality of life (HRQoL). Importantly, symptoms in a cluster may share a common biological mechanism. Here we review the clinical impact of CKD-aP and its association with other symptoms reported by dialysis patients. The clinical benefits of treating pruritus and its potential impact on other symptoms are also addressed. Recent findings Studies have shown CKD-aP significantly impairs HRQoL in patients with ESKD undergoing dialysis and is associated with adverse clinical outcomes, including increased risk of infections, hospitalizations, and mortality. Despite these negative effects, CKD-aP remains underrecognized and undertreated in clinical practice. CKD-aP is frequently associated with other symptoms, including disturbed sleep/poor sleep quality, anxiety, depression, and pain. Clinical studies of antipruritic therapies show that reduction of itch intensity may also alleviate other associated symptoms, such as poor sleep quality. Summary CKD-aP and its associated symptoms are inadequately managed in clinical practice. Greater understanding and awareness of CKD-aP and its surrounding symptom clusters in dialysis patients may improve their overall symptom management and HRQoL.

Objective The two approaches to symptom-cluster research include grouping symptoms and grouping patients. The objective of this systematic review was to examine the conceptual approaches and methodologies used in symptom-cluster research in patients with head and neck cancer. Data sources Articles were retrieved from electronic databases (CINAHL, MEDLINE via Ovid, APA PsycINFO, Scopus, Embase, and Cochrane Central Register of Controlled Trials-CENTRAL), five grey literature portals, and Google Scholar. Seventeen studies met the eligibility criteria. Eight studies grouped symptoms to identify symptom clusters, of which two used qualitative methods. The number of symptom clusters ranged from two to five, and the number of symptoms in a cluster ranged from 2 to 11. Nine studies grouped patients based on their experiences with multiple symptoms. Cluster analysis and factor analysis were most commonly used. Despite variable names and composition of symptom clusters, synthesis revealed three prominent symptom clusters: general, head and neck cancer-specific, and gastrointestinal. Being female and quality of life were significantly associated with high symptom group or cluster severity. Biological mechanisms were sparsely examined. Conclusion Symptom cluster research in head and neck cancer is emerging. Consensus on nomenclature of a symptom cluster will facilitate deduction of core clinically relevant symptom clusters in head and neck cancer. Further research is required on understanding patients’ subjective experiences, identifying predictors and outcomes, and underlying mechanisms for symptom clusters. Implications for Nursing Practice Identification of clinically relevant symptom clusters would enable targeted symptom assessment and management strategies, thus improving treatment efficiencies and patient outcomes.

The quantification of metabolites in blood and urine allows nurses to explore new hypotheses about the microbiome. This review summarizes findings from recent studies with a focus on how the state of the science can influence future nursing research initiatives. Metabolomics can advance nursing research by identifying physiologic/pathophysiologic processes underlying patients’ symptoms and can be useful for testing the effects of nursing interventions. To date, metabolomics has been used to study cardiovascular, respiratory, endocrine, autoimmune, and infectious conditions, with research focused on understanding the microbial metabolism of substrates resulting in circulating/excreted biomarkers such as trimethylamine N-oxide. This review provides specific recommendations for the collection of specimens and goals for future studies.

Over the course of four billion years, humans have developed an intimate relationship with the more than 37 trillion microbes that inhabit our bodies. This relationship runs the gamut from symbiosis to pathogenesis. The number of microbial cells is roughly equivalent to that of mammalian cells in the body. However, due to substantial microbial diversity in host-associated communities, the genetic content of the microbiome is roughly 150 times greater than that of the human genome. Microbial genes encode for proteins capable of producing a wide variety of molecules essential for our health and survival. Many factors such as mode of birth, diet, chlorination of water, and medications significantly affect the richness and diversity of the microbiome. Advanced practice nurses have important roles to play as clinicians, scientists, educators, and patient advocates as our understanding of the microbiome's effects on health becomes better articulated. An understanding of how the microbiome can affect an individual's health or the efficacy of treatment will soon be essential in the clinical setting, and nurses should be encouraged to educate themselves on the relationship between our microbial partners, the environment, and human health.

Background Symptom burden associated with chronic kidney disease can be debilitating, with a negative effect on patient health-related quality of life. Latent class clustering analysis is an innovative tool for classifying patient symptom experience. Objectives The aim of the study was to identify subgroups of patients at greatest risk for high symptom burden, which may facilitate development of patient-centered symptom management interventions. Methods In this cross-sectional analysis, baseline data were analyzed from 3,921 adults enrolled in the Chronic Renal Insufficiency Cohort Study from 2003 to 2008. Latent class cluster modeling using 11 items on the Kidney Disease Quality of Life symptom profile was employed to identify patient subgroups based on similar observed physical symptom response patterns. Multinomial logistic regression models were estimated with demographic variables, lifestyle and clinical variables, and self-reported measures (Kidney Disease Quality of Life physical and mental component summaries and the Beck Depression Inventory). Results Three symptom-based subgroups were identified, differing in severity (low symptom, moderate symptom, and high symptom). After adjusting for other variables in multinomial logistic regression, membership in the high-symptom subgroup was less likely for non-Hispanic Blacks and men. Other factors associated with membership in the high-symptom subgroup included lower estimated glomerular filtration rate, history of cardiac/cardiovascular disease, higher Beck Depression Inventory scores, and lower Kidney Disease Quality of Life physical and mental component summaries. Discussion Three symptom subgroups of patients were identified among patients with mild-to-moderate chronic kidney disease. Several demographic and clinical variables predicted membership in subgroups. Further research is needed to determine if symptom subgroups are stable over time and can be used to predict healthcare utilization and clinical outcomes.

Nurse scientists play an important role in studying complex relationships among human genetics, environmental factors, and the microbiome, all of which can contribute to human health and disease. Therefore, it is essential that they have the tools necessary to execute a successful microbiome research study. The purpose of this article is to highlight important methodological factors for nurse scientists to consider when designing a microbiome study. In addition to considering factors that influence host-associated microbiomes (i.e., microorganisms associated with organisms such as humans, mice, and rats), this manuscript highlights study designs and methods for microbiome analysis. Exemplars are presented from nurse scientists who have incorporated microbiome methods into their program of research. This review is intended to be a resource to guide nursing-focused microbiome research and highlights how study of the microbiome can be incorporated to answer research questions.

Background Patient access to health information using electronic patient portals is increasingly common. Portal use has the potential to improve patients’ engagement with their health and is particularly important for patients with chronic illness; however, patients’ abilities, attitudes, and use of portals are poorly understood. Methods A single-center, cross-sectional survey was conducted of 240 consecutive pre- and post-kidney transplant patients of all levels of technological proficiency who presented to an urban transplant center in the United States. The investigator-developed Patient Information and Technology Assessment-Patient Portal was used to assess patients’ attitudes towards the use of patient portals. Results Most patients surveyed did not use the patient portal (n = 176, 73%). Patients were more likely to use the patient portal if they were White, highly educated, in the post-transplant period, more comfortable with technology, and reported being a frequent internet user (P Conclusions We identified several modifiable barriers to patient portal use. Some barriers can be addressed by patient education and training on portal use, and federal initiatives are underway to improve interoperability; however, a preference for traditional communications represents the most prominent barrier. Additional strategies are needed to improve portal adoption by encouraging acceptance of technologies as a way of clinical communication.

Background: Despite our knowledge of barriers to the early stages of the transplant process, we have limited insight into patient-reported barriers to the prekidney transplant medical evaluation in populations largely at-risk for evaluation failure. Methods: One-hundred consecutive adults were enrolled at an urban, Midwestern transplant center. Demographic, clinical, and quality of life data were collected prior to patients visit with a transplant surgeon/nephrologist (evaluation begins). Patient-reported barriers to evaluation completion were collected using the Subjective Barriers Questionnaire 90-days after the initial medical evaluation appointment (evaluation ends), our center targeted goal for transplant work-up completion. Results: At 90 days, 40% of participants had not completed the transplant evaluation. Five barrier categories were created from the 85 responses to the Subjective Barriers Questionnaire. Patient-reported barriers included poor communication, physical health, socioeconomics, psychosocial influences, and access to care. In addition, determinants for successful evaluation completion included being of white race, higher income, free of dialysis, a lower comorbid burden, and reporting higher scores on the Kidney Disease Quality of Life subscale role-emotional. Conclusion: Poor communication between patients and providers, and among providers, was the most prominent patient-reported barrier identified. Barriers were more prominent in marginalized groups such as ethnic minorities and people with low income. Understanding the prevalence of patient-reported barriers may aid in the development of patient-centered interventions to improve completion rates.

The purpose of this review was to synthesize evidence on symptom clusters in patients with chronic kidney disease (CKD). The quality of studies was evaluated using the Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies. Twelve articles met inclusion criteria. Patients had CKD ranging from Stages 2 through 5. Most studies determined clusters using variable-centered approaches based on symptoms; however, one used a person-centered approach based on demographic and clinical characteristics. The number of clusters identified ranged from two to five. Several clusters were prominent across studies including symptom dimensions of fatigue/energy/sleep, neuromuscular/pain, gastrointestinal, skin, and uremia; however, individual symptoms assigned to clusters varied widely. Several clusters correlated with patient outcomes, including health-related quality of life and mortality. Identifying symptom clusters in CKD is a nascent field, and more research is needed on symptom measures and statistical methods for clustering. The clinical implications of symptom clusters remain unclear.

Background. As health-related communications become digitized, strategies to increase adoption of these Web-based platforms are needed. The purpose of this study was to assess facilitators and barriers to in-home Internet use among prekidney and postkidney transplant patients. Methods. A single center, cross-sectional survey of 240 consecutive patients of all levels of technological proficiency who presented to an urban transplant center in the United States. The Patient Information and Technology Assessment consists of 6 demographic questions, 3 disease-related questions, and 8 technology-related questions. Results. Much of the sample was African American, male with a mean age of 51 years, and median income of $53 800/year. Logistic regression analysis was undertaken, and after adjusting for covariates, we found Smartphone ownership (odds ratio [OR], 4.94; 95% confidence interval [CI], 2.32-10.52), a higher number of Internet users in the home (OR, 2.00; 95% CI, 1.11-3.62), and having college education and beyond (OR, 4.88; 95% CI, 2.03-11.74) increased the likelihood of being a frequent Internet user. African American or Hispanic/Latino patients were less likely to be frequent Internet users compared with white patients (OR, 0.26 and 0.24, respectively, compared with whites, all P < 0.05). As the total number of people in the household increased, frequent Internet use decreased (OR, 0.52; 95% CI, 0.29-0.92). As age increased, reports of frequent Internet use decreased. Conclusions. Lower rates of Internet use among African Americans and Hispanic/Latinos in urban areas in the United States remains a problem despite a significant increase in access to the Internet and Smartphone ownership. The finding that Internet use increases as the number of Internet users in the household increases indicates that leveraging the patient’s social support network and/or the development of patient information champion programs may aid with patient’s adoption of health technology and patient engagement in self-care.

Context Barriers to kidney transplant for African Americans are well documented in the literature. Little information on ownership of information and communication technology and use of such technology in transplant populations has been published. Objective To characterize racial differences related to ownership and use of information and communication technology in kidney transplant patients. Design A single-center, cross-sectional survey study. Setting An urban Midwestern transplant center. Participants 78 pretransplant patients and 177 transplant recipients. Main Outcomes Measures The survey consisted of 6 demographic questions, 3 disease-related questions, and 9 technology-related questions. Dichotomous (yes/no) and Likert-scale items were the basis for the survey. Results Cell phone use was high and comparable between groups (94% in African Americans, 90% in whites, P = .22). A vast majority (75% of African Americans and 74% of whites) reported being “comfortable” sending and receiving text messages. Computer ownership (94.3% vs 79.3%) and Internet access (97.7% vs 80.7%) were greater among whites than African Americans (both P < .01). Fewer African Americans were frequent users of the Internet (27.1% vs 56.3%) and e-mail (61.6% vs 79.3%) than whites (both P < .01). More African Americans than whites preferred education in a classroom setting (77% vs 60%; P < .005) and educational DVDs (66% vs 46%; P < .002). Conclusion The use of cell phone technology and text messaging was ubiquitous and comparable between groups, but computer and Internet access and frequency of use were not. Reaching out to the African American community may best be accomplished by using cell phone/text messaging as opposed to Internet-based platforms.

African Americans face a disproportionate burden related to the incidence of end stage renal disease. A literature search was conducted for research articles published between 2006-2015 to synthesize current literature related to non-biological barriers to early stages of the pre-kidney transplant continuum for African Americans in the United States. Twenty-four articles were included in the final sample. Eleven barriers were identified. Barriers were categorized as socioeconomic-based barriers, culture-based barriers, and knowledge-based barriers. Resources to develop educational interventions for both patients and providers may help reduce existing barriers.

ContextThe Internet is a staple of electronic communication and is essential to the emerging telemonitoring and health information technology interventions for adults with chronic diseases.ObjectiveTo identify determinants of frequent Internet use in an urban kidney transplant population in the United States.DesignA single center, cross-sectional survey studySettingAn urban Midwestern transplant centerParticipants78 pretransplant and 177 posttransplant patientsMain Outcome MeasuresFrequent Internet use, defined as using the Internet more than 5 hours per week.ResultsOnly 38% of participants reported being frequent Internet users. Non-Hispanic blacks and participants who reported their race/ethnicity as “other” were significantly less likely than whites to report being frequent Internet users. Women were 59% less likely than men to be frequent users of the Internet. Those who reported having kidney disease for more than 3 years were more likely to report being frequent Internet users. As education increased, Internet use increased. As age increased, Internet use decreased.ConclusionAlternatives to electronic information sources and/or additional resources should be considered for those who may fall in the so-called digital divide.

Prophylaxis reduces cytomegalovirus (CMV) disease, but is associated with increased costs and risks for side effects, viral resistance and late onset CMV disease. Preemptive therapy avoids drug costs but requires frequent monitoring and may not prevent complications of asymptomatic CMV replication. Kidney transplant recipients at risk for CMV (D+/R-, D+/R+, D-/R+) were randomized to prophylaxis (valganciclovir 900 mg q.d. for 100 days, n=49) or preemptive therapy (900 mg b.i.d. for 21 days, n=49) for CMV DNAemia (CMV DNA level>2000 copies/mL in >or=1 whole blood specimens by quantitative PCR) assessed weekly for 16 weeks and at 5, 6, 9 and 12 months. More patients in the preemptive group, 29 (59%) than in the prophylaxis group, 14 (29%) developed CMV DNAemia, p=0.004. Late onset of CMV DNAemia (>100 days after transplant) occurred in 11 (24%) randomized to prophylaxis, and none randomized to preemptive therapy. Symptomatic infection occurred in five patients, four (3 D+/R- and 1 D+/R+) in the prophylactic group and one (D+/R-) in the preemptive group. Peak CMV levels were highest in the D+/R- patients. Both strategies were effective in preventing symptomatic CMV. Overall costs were similar and insensitive to wide fluctuations in costs of either monitoring or drug.

As of October 1, 2007, 25 North American medical institutions and one European islet transplant center reported detailed information to the Registry on 315 allograft recipients, of which 285 were islet alone (IA) and 30 were islet after kidney (IAK). Of the 114 IA recipients expected at 4 years after their last infusion, 12% were insulin independent, 16% were insulin dependent with detectable C-peptide, 40% had no detectable C-peptide, and 32% had missing C-peptide data or were lost to follow-up. Of the IA recipients, 72% achieved insulin independence at least once over 3 years and multiple infusions. Factors associated with achievement of insulin independence included islet size >1.0 expressed as IEQs per islet number [hazard ratio (HR) = 1.5, p = 0.06], additional infusions given (HR = 1.5, p = 0.01), lower pretransplant HbA1c (HR = 1.2 each %-age unit, p = 0.02), donor given insulin (HR = 2, p = 0.003), daclizumab given at any infusion (HR = 1.9, p = 0.06), and shorter cold storage time (HR = 1.04, p = 0.03), mutually adjusted in a multivariate model. Severe hypoglycemia prevalence was reduced from 78–83% preinfusion to less than 5% throughout the first year post-last infusion, and to 18% adjusted for missing data at 3 years post-last infusion. In Year 1 post-first infusion for IA recipients, 53% experienced a Grade 3–5 or serious adverse event (AE) and 35% experienced a severe AE related to either an infusion procedure or immunosuppression. In Year 1 post-first infusion, 33% of IA subjects and 35% of IAK subjects had an AE related to the infusion procedure, while 35% of IA subjects and only 27% of IAK subjects had an AE related to the immunosuppression therapy. Five deaths were reported, of which two were classified as probably related to the infusion procedure or immunosuppression, and 10 cases of neoplasm, of which two were classified as probably related to the procedure or immunosuppression. Islet transplantation continues to show short-term benefits of insulin independence, normal or near normal HbA1c levels, and sustained marked decrease in hypoglycemic episodes.

Background To date, the clinical trials of tacrolimus (TAC) versus cyclosporine modified (CsA), have not defined which agent is more cost-effective for immunosuppression in renal transplant recipients especially in a quadruple immunosuppressive regimen. Methods The objective of this randomized, prospective study was to compare the clinical and economic outcomes of TAC versus CsA, in a regimen that consisted of Thymoglobulin induction, an antimetabolite, and prednisone. Between December 2000 and October 2002, 200 patients were enrolled and randomized in a 2:1 fashion (TAC n=134, CsA n=66). Results At 1 year, acute rejection (4% TAC vs. 6% CsA), patient survival (TAC 99% vs. CsA 100%), and graft survival (95% TAC versus 100% CsA, P=0.059) were similar. Serum creatinine levels were lower in the TAC group compared with the CsA group (1.3+/-0.3 vs. 1.6+/-0.7 mg/dL, P=0.03). The incidence of CMV infection was similar between the groups and two patients, both in the TAC arm, developed malignancy. Anti-hypertensive requirement (32% TAC vs. 32% CsA) and the incidence of posttransplant diabetes mellitus (4% TAC vs. 2% CsA) were similar. Pretransplant, fewer TAC patients received dyslipidemia treatment (40% TAC vs. 67% CsA, P=0.0005), while more CsA patients were able to discontinue these medications posttransplant (absolute change 25% TAC vs. 47% CsA). Total 12-month medication costs were similar (17,723 +/- 11,647 dollars TAC vs. 16,515 +/- 10,189 dollars CsA). Conclusions When combined with Thymoglobulin induction, an antimetabolite, and corticosteroids, TAC and CsA are comparable in safety, efficacy, and cost in renal transplantation.

Our purposes were to determine the incidence of BK viruria, viremia or nephropathy with tacrolimus (FK506) versus cyclosporine (CyA) and whether intensive monitoring and discontinuation of mycophenolate (MMF) or azathioprine (AZA), upon detection of BK viremia, could prevent BK nephropathy. We randomized 200 adult renal transplant recipients to FK506 (n = 134) or CyA (n = 66). Urine and blood were collected weekly for 16 weeks and at months 5, 6, 9 and 12 and analyzed for BK by polymerase chain reaction (PCR). By 1 year, 70 patients (35%) developed viruria and 23 (11.5%) viremia; neither were affected independently by FK506, CyA, MMF or AZA. Viruria was highest with FK506-MMF (46%) and lowest with CyA-MMF (13%), p = 0.005. Viruria >/= 9.5 log(10) copies/mL was associated with a 3-fold increased risk of viremia and a 13-fold increased risk of sustained viremia. After reduction of immunosuppression, viremia resolved in 95%, without increased acute rejection, allograft dysfunction or graft loss. No BK nephropathy was observed. Choice of calcineurin inhibitor or adjuvant immunosuppression, independently, did not affect BK viruria or viremia. Viruria was highest with FK506-MMF and lowest with CyA-MMF. Monitoring and preemptive withdrawal of immunosuppression were associated with resolution of viremia and absence of BK nephropathy without acute rejection or graft loss.