Lowering A1c Through Integrated Behavioral Health Group Visits.

INTRODUCTION & OBJECTIVE: Suboptimal adherence to medication and lifestyle modification continues to be a problem in diabetic patients in the US. Previous studies have investigated the potential of group educational visits in improving medication adherence and short-term health outcomes, but few have done so using a biopsychosocial approach in visits. This study aimed to evaluate the effect that group visits, conducted using an integrated behavioral health model at a primary care practice, had on A1c and distress levels in diabetic adults. METHODS: Using the Diabetic Distress Scale (DDS), 15 adults were identified as having moderate diabetic distress (> 3.0) between December 2016 and May 2017 and invited to attend a group visit in May 2017 to address identified barriers. Of those, nine attended. The group visit, conducted by a psychologist, sought to reduce diabetic distress by targeting behavioral and social factors, including improving social and familial support, using diabetes online forums, and improving mind-body connection. Repeat A1c and DDS measurements for all nine visit participants were collected three months after. RESULTS: Group visit participants experienced a decrease in A1c (p=0.011). All nine participants had a decrease in their post-intervention DDS. Of the six patients who had positive DDS screens but did not attend, three had increased A1c, two had no change, one had a decrease, and one did not have a repeat A1c. CONCLUSIONS: Multidisciplinary group visits targeting the biopsychosocial model may be an efficient supplement to the individual medical visit to further improve control of diabetic distress and short-term morbidity in Rhode Island.

Quality of life in adults with nonalcoholic fatty liver disease: baseline data from the nonalcoholic steatohepatitis clinical research network.

UNLABELLED: Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in the United States. The association between NAFLD and quality of life (QOL) remains unclear. These data are important to estimate the burden of illness in NAFLD. The aim was to report QOL scores of adults with NAFLD and examine the association between NAFLD severity and QOL. QOL data were collected from adults with NAFLD enrolled in the Nonalcoholic Steatohepatitis Clinical Research Network using the Short Form 36 (SF-36) survey, and scores were compared with normative U.S. population scores. Liver biopsy histology was reviewed by a central pathology committee. A total of 713 subjects with NAFLD (male = 269, female = 444) were included. Mean age of subjects was 48.3 years; 61% had definite nonalcoholic steatohepatitis (NASH), and 28% had bridging fibrosis or cirrhosis. Diabetes was present in 27% of subjects. Subjects with NAFLD had worse physical (mean, 45.2) and mental health scores (mean, 47.6) compared with the U.S. population with (mean, 50) and without (physical, 55.8; mental, 52.5) chronic illness. Subjects with NASH reported lower physical health compared with subjects with fatty liver disease without NASH (44.5 versus 47.1, P = 0.02). Subjects with cirrhosis had significantly (P < 0.001) poorer physical health scores (38.4) than subjects with no (47.6), mild (46.2), moderate (44.6), or bridging fibrosis (44.6). Cirrhosis was associated with poorer physical health after adjusting for potential confounders. Mental health scores did not differ between participants with and without NASH or by degree of fibrosis. CONCLUSION: Adults with NAFLD have a significant decrement in QOL. Treatment of NAFLD should incorporate strategies to improve QOL, especially physical health.

Real-world doxercalciferol treatment in SHPT CKD stage 3 and 4: an analysis of change in iPTH and accordance to KDOQI recommendations.

BACKGROUND: National Kidney Foundation's Kidney Disease Outcome Quality Initiative (KDOQI) guidelines offer an outline for providing standardized care for best outcomes in chronic kidney disease (CKD). It is unknown whether real-world treatment practices follow these guidelines. METHODS: The Hectorol Registry Outcome in Chronic Kidney Disease (HeROICkd), an observational patient registry, captured information on adult patients with CKD Stage 3 or 4 throughout US clinics during a 9-month observation period. Data were collected quarterly from patients' medical records, throughout each patient's normal treatment course. The proportion of patients with intact parathyroid hormone (iPTH) levels within KDOQI guidelines, change in iPTH, Ca, P, and Ca x P product over the 9-month observation period, incidence of hypercalcemia and hyperphosphatemia, and predictors of change in iPTH were examined. RESULTS: 1,339 CKD Stage 3 and 4 patients from 78 nephrology and internal medicine clinics were included. 40% of CKD Stage 3 participants and 45% of Stage 4 had a 30% or greater reduction in iPTH levels from baseline to 9 months follow-up. While the proportion of CKD Stage 3 and 4 participants with iPTH levels within the KDOQI recommendations improved significantly over the 9 months, it was still modest, at 28% and 23%, respectively. Mean doxercalciferol dose was below that recommended in the package insert and a minority of patients had all mineral metabolism parameters (iPTH, Ca, P) regularly recorded in their medical records. CONCLUSIONS: The results of this registry, which examined iPTH treatment with doxercalciferol in CKD Stage 3 and 4, suggest that in the real-world treatment setting, the adherence to KDOQI guidelines is not optimal.

The association between MMF and risk of progressive renal dysfunction and death in adult liver transplant recipients with HCV.

The impact of a three-drug regimen including mycophenolate mofetil (MMF) vs. a two-drug (no MMF) regimen on progressive renal dysfunction (PRD) in liver transplant recipients with hepatitis C virus (HCV) infection has not been well described. Adults with HCV who received a primary liver transplant between January 1, 2000 and December. 31, 2005 and were discharged from the hospital on a three-drug regimen [CNI+MMF+steroids (S)] (n = 4 946) were compared with those discharged on two-drug regimen (CNI+S) (n = 3 884). Time to PRD (defined by a post-transplant 25% decline in estimated GFR, based on the four-variable MDRD equation) and recipient death were evaluated using Kaplan-Meier analysis. Cox proportional hazards regression was used to estimate the risk for post-transplant PRD and death after controlling for baseline characteristics and extended steroid use. The two groups were similar in baseline characteristics. The percentage of recipients on three- vs. two-drug regimen without PRD was higher, 36.8% vs. 31.9%, (p < 0.001), at three yrs post-transplant; three-drug therapy was associated with a 6% lower adjusted risk of PRD. The death rate and adjusted risk for death was lower for recipients on a three- vs. two-drug regimen. Liver transplant recipients with HCV on a MMF-containing regimen are at a lower risk for PRD and death compared with recipients on a regimen not including MMF.

Pre-medication practices and incidence of infusion-related reactions in patients receiving AMPHOTEC: data from the Patient Registry of Amphotericin B Cholesteryl Sulfate Complex for Injection Clinical Tolerability (PRoACT) registry.

BACKGROUND: Clinical studies have suggested that rates of infusion-related reactions (IRRs) may be higher with amphotericin B colloidal dispersion (ABCD) versus other forms of amphotericin B. However, these studies did not permit the use of pre-medications upfront, which are now commonly used. Objectives To describe the use of pre-medications and determine the rate of IRRs in the real-world setting. METHODS: PRoACT, a multicentre, worldwide observational registry, captured real-world data about pre-medication practices and IRRs in patients receiving ABCD. Eligible patients were those beginning treatment with ABCD; treatment was according to the site's standard treatment practice. Incidence of IRRs was collected during the first 10 days of ABCD therapy. Clinical response data were collected 12 weeks after treatment start. RESULTS: One hundred and seventy patients from 21 worldwide sites were included (median age 37 years; 52% male). There were a total of 1230 ABCD infusions (mean dose 2.8 mg/kg/day); 90% of the infusions (1105/1230) had pre-medication. Common pre-medications included corticosteroids, antihistamines, paracetamol (acetaminophen) and metamizole. The overall IRR rate was 12% (147/1230) and was lower in infusions with pre-medication (11%) versus no pre-medication (22%), P < 0.001. Corticosteroids were associated with a decreased incidence of IRRs (P < 0.05), while paracetamol and antihistamines were not. The most common IRRs were chills (7%), fever (7%) and rigors (5%). Clearance of the fungal infection occurred in 52% of the participants. CONCLUSIONS: These data suggest a lower rate of IRRs with ABCD than previously reported. Pre-medication is associated with decreased IRR incidence. Corticosteroids in particular appear to decrease IRRs while paracetamol and antihistamines, though commonly used, do not.

Use of the quality of well-being self-administered version (QWB-SA) in assessing health-related quality of life in depressed patients.

BACKGROUND: This study evaluated the cross-sectional and longitudinal relationship between depression severity and the Quality of Well-Being scale self-administered version (QWB-SA) in subjects diagnosed with current major depression. METHODS: The research design was prospective and observational. Data were collected on a convenience sample of 58 subjects. Additional measures included the Quality of Well-Being scale interviewer-version (interviewer-QWB), Hamilton Rating Scale for Depression (HRSD-17), Beck Depression Inventory, and each were collected at baseline, 4 weeks, and 4 months postmedication treatment. RESULTS: Cross-sectional and longitudinal QWB-SA scores were significantly correlated with depression severity and the interviewer-QWB. Treatment response, defined as 50% improvement in HRSD-17, was associated with 0.10 and 0.16 unit changes in the QWB-SA at 4 weeks and 4 months, respectively. The QWB-SA was significantly and negatively correlated with cross-sectional and longitudinal depression severity. LIMITATIONS: The study design was observational and used a convenience sample of subjects. CONCLUSIONS: The QWB-SA is less expensive to administer than the interviewer-QWB and is a useful alternative for determining the effectiveness and cost-effectiveness of treatments for depression relative to other physical and mental illness treatments.

Switching immunosuppression medications after renal transplantation--a common practice.

BACKGROUND: The rate of change to immunosuppression discharge regimens over time is unknown. We examined the frequency of changes to initial drug treatment regimens and factors associated with a drug change following renal transplantation. METHODS: Scientific Registry of Transplant Recipients data from adult recipients who underwent primary renal transplantation between January 1998 and December 2002 were analysed. The Kaplan-Meier analysis was used to determine the frequency of regimen changes for the most common immunosuppression discharge regimens, type of change, and to examine switching between the calcineurin inhibitors tacrolimus (Tacro) and ciclosporin United States Pharmacopera (USP) modified (CsA). Cox proportional hazard regression was used to examine recipient, donor and transplant characteristics associated with a drug change. RESULTS: The majority of patients experienced a change to their discharge regimen post-transplantation, and more changes were observed within higher-risk sub-groups of patients. Switching from CsA to Tacro was more common than Tacro to CsA. Significant factors associated with a drug change included those associated with graft loss. CONCLUSIONS: Significant immunosuppression regimen changes occur during the first 4 years post-transplantation. It is possible that early graft survival benefits proven in prospective clinical trials may not translate into long-term success in clinical practice, possibly in part because efficacious regimens are not necessarily maintained long-term.

Mycophenolate mofetil vs. azathioprine is associated with decreased acute rejection, late acute rejection, and risk for cardiovascular death in renal transplant recipients with pre-transplant diabetes.

Outcomes specifically in mycophenolate mofetil (MMF)-treated diabetic renal transplant patients have not been previously reported. This study compared acute rejection (AR), late acute rejection (LAR), patient survival [and specifically death from cardiovascular (CV), infectious and malignant causes], incidence of post-transplant malignancies, and graft loss in MMF- or azathioprine (AZA)-treated renal transplant patients with pre-transplant diabetes. Outcomes were compared between MMF- (n = 14 144) and AZA- (n = 3001) treated diabetic patients using the Scientific Registry of Transplant Recipients data on all U.S. adult renal transplants performed between 1995 and 2002. Statistical analyses included Kaplan-Meier survival analysis, Cox multivariable regression and chi-square tests. MMF patients had less AR compared with AZA-treated patients (23.5% vs. 28.3%, p < 0.001) and less risk for LAR over 4 yr [hazard ratio (HR): 0.64, 95% CI 0.44, 0.92; p = 0.02]. While time to any-cause death did not differ between the groups, MMF treatment was associated with a 20% decreased risk of CV death (HR: 0.80, 95% CI 0.67, 0.97; p = 0.020) compared with AZA treatment. MMF patients also had a lower incidence of malignancies than AZA patients (2.2% vs. 3.7%, p < 0.001). These results suggest treatment with MMF compared with treatment with AZA in diabetic transplant patients is associated with less AR, less risk of LAR, a decreased risk of CV death, and a lower incidence of malignancies.