Externally Oriented Thinking Predicts Phosphorus Levels in Dialyzed Patients.

BACKGROUND: The aim of the present study was to investigate the association between alexithymia scores and biological markers of adherence in dialyzed patients. The hypothesis was that higher scores of alexithymia would be associated with lower adherence to treatment. METHODS: Fifty-four adult dialyzed patients were enrolled during a follow-up visit. Participants were asked to complete a self-report questionnaire, namely, the Toronto Alexithymia Scale (TAS-20). Moreover, biological markers levels of adherence to treatment (phosphorus, creatinine, and serum uric acid) were measured. RESULTS: A positive correlation was found between phosphorous levels and TAS-F2 (r = 0.28; P = .04) and TAS-F3 (r = -0.31; P = .02). Stepwise regression with TAS-F2 and TAS-F3 as predictors of adherence to treatment showed a significant model, adjusted R(2) = 0.08, F(1,52) = 5.4; P < .02, where only TAS-F3 was able to predict phosphorous levels (P = .02). CONCLUSIONS: Findings showed that external oriented thinking was able to predict a biological marker of adherence to treatment in dialyzed patients.

Expanding the Living Donor Pool "Second Act": Laparoscopic Donor Nephrectomy and ABO-Incompatible Kidney Transplantation Improve Donor Recruitment.

BACKGROUND: To safely expand our living donor pool, we recently decided to work on 3 areas: analysis of causes of exclusion of potential donors, the results of which we recently published, introduction of laparoscopic donor nephrectomy (LDN), and ABO-incompatible (ABOi) transplantation. We sought to determine the impact of the new strategy on living donor recruitment and transplantation during over a 10-year period at a single institution. METHODS: From January 2005 to September 2014, we evaluated 131 living donors. Of these, 80 (61%) were genetically related, 51 (39%) unrelated, 119 (91%) ABO compatible (ABOc), 12 ABOi (9%). The analysis was divided into 2 eras: era 1, 2005-2010 (n = 53) included the use of open lumbotomy and acceptance of ABOc only; and era 2, 2011-2014 (n = 78), which saw the introduction of LDN and ABOi transplantation. RESULTS: Forty-five (34%) potential candidates successfully donated, 67 (51%) were excluded, and 19 (15%) were actively undergoing evaluation. Overall, 53 potential donors were evaluated in era 1 (8.8 donors/year), 78 in era 2 (19.5 donors/year). There were fewer excluded donors in era 2 vs era 1 (62% era 1 vs 44% era 2), and living donor kidney transplantation (LDKT) significantly increased in era 2 vs era 1 (3.3/year era 1 vs 7.1/year era 2). The establishment of an ABOi LDKT program led to a 15% increase of evaluations in era 2 (12/78 donors). CONCLUSIONS: LDN along with ABOi LDKT allowed for an improvement in recruitment of living donors and corresponding LDKT.

Conversion from Prograf to Advagraf in stable kidney transplant recipients: better renal function after 3-year follow-up.

BACKGROUND: The complexity of treatment after solid organ transplantation has been related to non-adherence to therapy prescriptions and to reduced graft survival. The aim of this study was to evaluate the middle-term effects of the conversion from Prograf (TAC), to extended-release tacrolimus (Advagraf) (ADV) in stable kidney transplant recipients. METHODS: Conversion from TAC to ADV (dose, 1:1 mg/mg) was planned in 78 kidney transplant patients with stable renal function 71±48 months after renal transplantation. Before conversion, 1 week after conversion, and every 6 months up to 3 years, patients were evaluated clinically and by means of the usual blood chemistry and pharmacologic parameters. RESULTS: Twenty patients (26%) refused to change their pre-existing immunosuppressive therapy; therefore, 58 patients entered the study and 45 (77%) completed the 3-year follow-up. Patient survival was 98% and allograft survival was 96%. Significant reduction in serum creatinine levels and increased glomerular filtration rate were observed after conversion (3-year creatinine: before TAC 1.67±0.47 mg/dL vs after ADV 1.47±0.62 mg/dL, P<.001; glomerular filtration rate, MDRD abbreviated: before TAC 49±15 mL/min vs after ADV 59±24 mL/min, P<.001). The daily dose and C0 blood levels of tacrolimus were stable before and after conversion (dose before vs 3 years after conversion: TAC 3.79±1.81 mg/day vs ADV 3.54±1.86 mg/day, P=ns; C0 tacrolimus blood levels, before vs 3 years after conversion: TAC 6.03±1.75 ng/mL vs ADV: 5.58±1.38 ng/mL, P = NS). One patient in the ADV group had an episode of acute rejection (2%). CONCLUSIONS: Our data support the safety and efficacy of converting from Prograf to Advagraf in stable kidney transplant patients in the middle term. We suggest that the observed improvement in renal function after conversion to ADV is related to the reduction of the 24-hour tacrolimus area under the curve exposure.

Do patients who participate in a clinic experimental protocol have the same probability of success from that who were not selected or refused to participate? Outcome surveillance, safety, and bioethical considerations in kidney transplant clinical research.

INTRODUCTION: Safety in conducting a clinical trial is a prerequisite for patients who will be enrolled into that study. The aim of the present study was to evaluate retrospectively if patient and graft survival were similar among patients who participated in clinical trials versus those who did not. PATIENTS AND METHODS: We evaluated pretransplant and posttransplant characteristics of 245 kidney transplant (KT) patients who were selected to participate in at least one Phase II/Phase III clinical trial. We compared them with 361 KT patients who were not enrolled or refused to participate in those clinical trials; all studies were conducted at a single transplant center. Inclusion/exclusion criteria were as noted for each individual protocol. Only studies with enrollment at time of graft implant were considered. RESULTS: Selection of patients participating in clinical trials in general exclude high-risk patients. In our experience, only 36% of transplanted patients were selected for a multicenter, prospective, randomized, international study that included changes to the strategies in the administration of immunosuppressive drugs already on the market or development of a new immunosuppressant. After 5 years, graft and patient survival rates were similar between those who participated and those who did not participate in a clinical study. Although our data were collected retrospectively, an alternative design to achieve these conclusions would be a noninferiority study. CONCLUSIONS: Our results demonstrated similar rates of graft and patient survival among enrolled patients versus nonenrolled patients. Outcome surveillance offers safety in participating in clinical trials that involve changes in standard immunosuppression therapy and are part of the research necessary to develop patient-centered medical interventions.

Expanding the living donor pool, "Ist Act": analysis of the causes of exclusion of potential kidney donors.

BACKGROUND: The evaluation of a potential living kidney donor (LKD) leads to exclusion of at least 50% of candidates. The aim of this study was to analyze the reasons for exclusion of potential LKDs referred to our center. METHODS: We retrospectively analyzed historic and clinical data of all potential LKDs who were evaluated over 7 years from January 2005 to March 2012. Data were obtained by review of an electronic database. RESULTS: Among 79 (50 female, 29 male) candidates, 24 (30.3%) successfully donated, comprising 22 related and 2 unrelated donors. We excluded 45 (56.9%), and 10 (12.6%) are actively undergoing evaluation. Reasons for exclusion were medical (n = 14; 31%), nonmedical (n = 18; 40%), positive cross-match (n = l7.7%), pregnancy (n = 2; 4.4%), and other reasons (n = 3; 6.6%). Of the 14 donors excluded for medical reasons, 75.8% were due to diabetes, cardiovascular disease, hypertension, or obesity and 21.5% to inadequate renal function, malignancy, or liver disease. Of the 18 (40%) excluded for nonmedical reasons, 6 (33.3%) were because the intended recipient received a deceased-donor transplantation before the evaluation could be completed, 5 (27.7%) because the recipient was no longer a candidate for transplantation, 5 (27.7%) because of donor withdrawal, and 2 (11.1%) for other reasons. CONCLUSIONS: Positive cross-match and deceased-donor transplantation during the evaluation process were the 2 most common reasons for LKD exclusion. Evaluation of potential LKDs is time consuming, requiring a remarkable amount of human and material resources. A dedicated pathway for the diagnostic work-up of LKDs may speed- the evaluation process and improve its efficiency, use of ABO-incompatible or paired-exchange donations may increase the yield of donor organs.

Psychological risk factors for graft rejection among liver transplant recipients.

The purpose of this prospective study was to find psychological risk factors predicting acute, chronic, and psychological rejection in patients undergoing liver transplantation using Cognitive Behavioural Assessment (CBA-2.0). The primary scale included an assessment of fears, personality, obsessive-compulsive symptoms, state and trait anxiety, psychological reactions, and depression. We prospectively recruited 44 patients undergoing orthotopic liver transplantation (OLT). Exclusion criteria were: education level below secondary school, unstable clinical situation in an out-patient setting, fulminant hepatitis, psychotic disorders, neurocognitive deficits, dementia, serious mental retardation, current alcohol or drug abuse, recent ideation of or attempted suicide, and non-adherence to therapy. CBA-2.0 primary scale series of questionnaires were handed out to patients immediately after the medical examination, which had been performed to ascertain eligibility for OLT. Rejection (acute and/or chronic) was diagnosed according to clinical and histopathological criteria. Psychological rejection was diagnosed when patients declared, after transplantation, a refusal of the new organ which caused psychiatric symptoms requiring medical treatment and/or psychotherapy. Analysis of variance and logistic regression of psychological variables was performed to detect possible risk factors for each type of rejection. A greater fear of repulsive animals was able a predictor for an acute rejection episode (odds ratio=1.1; P<.05). No other psychological pretransplant predictor was noted for chronic or psychological rejection. In patients undergoing OLT, preoperative emotions of fear could predict an acute graft rejection episode. These findings imply that pre-OLT screening should include psychological factors in addition to traditional medical criteria with intervention in selected cases.

Preoperative psychological factors predicting graft rejection in patients undergoing kidney transplant: a pilot study.

BACKGROUND: The aim of this study was to investigate whether pretransplant psychological variables included in the CBA 2.0 Primary Scale-fear, personality, obsessive-compulsive symptoms, state and trait anxiety, psychological reactions, and depression-could predict graft rejection among patients undergoing kidney transplantation. METHODS: After ethical committee approval we enrolled 33 consecutive adult patients undergoing kidney transplantation. The inclusion criteria were a stable clinical situation in an out-of-hospital setting; Italian language literacy; a minimum of secondary school-level education, and written informed consent. We excluded patients with a psychotic disturbance, neurocognitive deficit, dementia, serious mental delay (IQ <50), current alcohol or drug abuse, recent ideation or attempted suicide or nonadherence to the therapeutic protocol. Acute and/or chronic graft rejection was diagnosed according to clinical and histopathologic criteria. CBA-2,0 "Primary Scale" series of questionnaires were handed out to patients at the time of the examinations to discrem eligibility for transplantation. Analyses of variance were performed to compare psychological scores among patients with versus without graft rejection. Logistic regression analyses of psychological variables were performed to detect possible predictors for graft rejection. The results of the analysis showed that higher psychoticism scores were able to predict graft rejection (P<.05). RESULTS: The findings of this study suggest that it is mandatory to preoperatively plan an holistic treatment including psychological intervention mainly focused on psychoticism.

Effects of switching from twice-daily to once-daily tacrolimus formulation on quality of life, anxiety, and transplant benefit perception after kidney transplantation.

OBJECTIVE: This study investigated whether switching from the twice-daily (Prograf; TAC) to the once-daily formulation of tacrolimus with extended release (Advagraf; XL) affected quality of life, anxiety, and transplant benefit perception after allogeneic kidney transplantation. METHODS: After local Institutional Review Board approval, 78 adult patients prescribed twice-daily tacrolimus for ≥1 year after kidney transplantation were asked to participate in this study. All patients were evaluated at T0 (before the switch), and the 49 who accepted the change were reassessed after 6 months (T1). The following tests were used: (State and Trait Anxiety Inventories Y1 and Y2, (Psychologic General Well-Being Index), and modified Transplant Effect Questionnaire for posttransplantation symptoms. Blood samples for laboratory profiles and determinations of drug concentrations were obtained throughout the study period. RESULTS: There were no significant differences between the psychologic variables at T0 among patients who switched from TAC to XL (n=49) versus those who did not participate (n=29). Eight of the 49 patients who accepted the drug conversion were reswitched to TAC because of adverse events. At T1, the remaining switched patients (n=41) showed an increase in the disclosure of having undergone transplantation (P<.05) versus nonswitched patients; whereas reswitched patients (n=8) showed less positivity and well-being (P<.05) compared with those who remained in the switched regimen. CONCLUSION: The findings suggested increased disclosure of having undergone transplantation among patients who decided to switch from TAC to XL.