Kristine Ruppert

Deploying the chronic care model to implement and sustain diabetes self-management training programs

PURPOSE The purpose of this project was to evaluate the utility of using the 6 elements of the chronic care model (CCM; health system, community, decision support, self-management support, clinical information systems, and delivery system design) to implement and financially sustain an effective diabetes self-management training (DSMT) program. METHODS The University of Pittsburgh Medical Center (UPMC) uses all elements of the CCM. Partnerships were formed between UPMC and western Pennsylvanian community hospitals and practices; the American Diabetes Association DSMT recognition program provided decision support. A clinical data repository and reorganization of primary care practices aided in supporting DSMT. The following process and patient outcomes were measured: number of recognized programs, reimbursement, patient hemoglobin A1C levels, and the proportion of patients who received DSMT in primary care practices versus hospital-based programs. RESULTS Using elements of the CCM, the researchers were able to gain administrative support; expand the number of recognized programs from 3 to 21; cover costs through increased reimbursement; reduce hemoglobin A1C levels (P < .0001), and increase the proportion of patients receiving DSMT through delivery in primary care (26.4% suburban; 19.8% urban) versus hospital-based practices (8.3%; P < .0001). CONCLUSIONS The CCM serves as an effective model for implementing and sustaining DSMT programs.

Recurrent Hepatitis C in Liver Allografts: Prospective Assessment of Diagnostic Accuracy, Identification of Pitfalls, and Observations About Pathogenesis

Rationale and Design:The accuracy of a prospective histopathologic diagnosis of rejection and recurrent hepatitis C (HCV) was determined in 48 HCV RNA-positive liver allograft recipients enrolled in an “immunosuppression minimization protocol” between July 29, 2001 and January 24, 2003. Prospective entry of all pertinent treatment, laboratory, and histopathology results into an electronic database enabled a retrospective analysis of the accuracy of histopathologic diagnoses and the pathophysiologic relationship between recurrent HCV and rejection. Results:Time to first onset of acute rejection (AR) (mean, 107 days; median, 83 days; range, 7–329 days) overlapped with the time to first onset of recurrent HCV (mean, 115 days; median, 123 days; range, 22–315 days), making distinction between the two difficult. AR and chronic rejection (CR) with and without co-existent HCV showed overlapping but significantly different liver injury test profiles. One major and two minor errors occurred (positive predictive values for AR = 91%; recurrent HCV = 100%); all involved an overdiagnosis of AR in the context of recurrent HCV. Retrospective analysis of the mistakes showed that major errors can be avoided altogether and the impact of unavoidable minor errors can be minimized by strict adherence to specific histopathologic criteria, close clinicopathologic correlation including examination of HCV RNA levels, and a conservative approach to the use of additional immunosuppression. In addition, histopathologic diagnoses of moderate and severe AR and CR were associated with relatively low HCV RNA levels, whereas relatively high HCV RNA levels were associated with a histopathologic diagnosis of hepatitis alone, particularly the cholestatic variant of HCV. Conclusions:Liver allograft biopsy interpretation can rapidly and accurately distinguish between recurrent HCV and AR/CR. In addition, the histopathologic observations suggest that the immune mechanism responsible for HCV clearance overlap with those leading to significant rejection.

Liver biopsy findings from healthy potential living liver donors: Reasons for disqualification, silent diseases and correlation with liver injury tests

BACKGROUND/AIMS Liver biopsies detect silent donor disease in potential living liver donors and provide material for studies of subclinical non-alcoholic fatty liver disease (NAFLD). Our primary goal was to determine the contribution of biopsy findings to potential donor evaluation. Factors contributing to pre-clinical NAFLD and correlations between liver injury tests and histopathology have been also determined. METHODS Patient records, laboratory tests and results of the histopathologic examination and diagnoses of 284 patients from 2001 to 2005 were retrospectively extracted from the EDIT database. Hepatic histology was correlated with liver injury tests and with general demographic characteristics in an otherwise normal healthy population. RESULTS A minority (n=119; 42%) of biopsies from this population of 143 males/141 females (average age=36.8years; mean BMI=26.6) were completely normal. The remainder showed steatosis (n=107; 37%), steatohepatitis (n=44; 15%), or unexplained low-grade/early stage chronic hepatitis, primary biliary cirrhosis, or nodular regenerative hyperplasia (n=16; 6%). Biopsy findings disqualified 29/56 donors. Independent risk factors for NAFLD by multivariate modeling, which differed by sex, included: BMI (p=0.0001), age (p=0.003), iron (p=0.01), and ALT (p=0.004). CONCLUSIONS Liver biopsies provide valuable information about otherwise undetectable liver disease in potential liver donors. Obesity, age and iron, which are influenced by sex, contribute to NAFLD pathogenesis. Blood tests other than standard liver profiles are needed to detect early NAFLD.

Chronic liver allograft rejection in a population treated primarily with tacrolimus as baseline immunosuppression: Long-term follow-up and evaluation of features for histopathological staging

BACKGROUND Predisposing factors, long-term occurrence, and histopathological changes associated with recovery or progression to allograft failure from chronic rejection (CR) were studied in adult patients treated primarily with tacrolimus. METHODS CR cases were identified using stringent criteria applied to a retrospective review of computerized clinicopathological data and slides. RESULTS After 1973 days median follow-up, 35 (3.3%) of 1049 primary liver allograft recipients first developed CR between 16 and 2532 (median 242) days. The most significant risk factors for CR were the number (P<0.001) and histological severity (P<0.005) of acute rejection episodes and donor age >40 years (P<0.03). Other demographic and matching parameters were not associated with CR in this cohort. Ten patients died with, but not of, CR. Eight required retransplantation because of CR at a median of 268 days. Ten resolved either histologically or by normalization of liver injury tests over a median of 548 days. CR persisted for 340 to 2116 days in the remaining seven patients. More extensive bile duct loss (P<0.01), smallarterial loss (P<0.03), foam cell clusters (P<0.01) and higher total bilirubin (P<0.02) and aspartate aminotransferase (P<0.03) were associated with allograft failure from CR. CONCLUSIONS Early chronic liver allograft rejection is potentially reversible and a combination of histological, clinical, and laboratory data can be used to stage CR. Unique immunological and regenerative properties of liver allografts, which lead to a low incidence and reversibility of early CR, can provide insights into transplantation biology.

Deficiencies of Cardiovascular Risk Prediction Models for Type 1 Diabetes

OBJECTIVE—Cardiovascular risk prediction models are available for the general population (Framingham) and for type 2 diabetes (U.K. Prospective Diabetes Study [UKPDS] Risk Engine) but may not be appropriate in type 1 diabetes, as risk factors including younger age at diabetes onset and presence of diabetes complications are not considered. Therefore, our objective was to examine the accuracy of Framingham and UKPDS models for predicting coronary heart disease (CHD) in a type 1 diabetic cohort. RESEARCH DESIGN AND METHODS—Ten-year follow-up data from the Pittsburgh Epidemiology of Diabetes Complications (EDC) study, a prospective cohort study of 658 subjects with childhood-onset type 1 diabetes diagnosed between 1950 and 1980 first seen in 1986–1988, were analyzed. EDC study data were used to calculate the 10-year probability of CHD (fatal CHD, nonfatal myocardial infarction, or Q-waves) applying to the Framingham and UKPDS equations. RESULTS—Mean age at CHD onset was 39 years. When fatal/nonfatal myocardial infarction and CHD death were modeled, both the UKPDS and Framingham models showed significant lack of calibration (P < 0.0001) but moderate discrimination (0.76 UKPDS, 0.77 Framingham men, and 0.88 Framingham women). Both the UKPDS and Framingham models underestimated probability of events in highest risk deciles. CONCLUSIONS—Currently available CHD models poorly predict events in type 1 diabetes. Future research should focus on determining the risk factors accounting for the lack of fit and developing prediction models specific to this high-risk group.

longitudinal analysis of levels of immunoglobulins against BK virus capsid proteins in kidney transplant recipients.

ABSTRACT This study sought to evaluate serology and PCR as tools for measuring BK virus (BKV) replication. Levels of immunoglobulin G (IgG), IgM, and IgA against BKV capsids were measured at five time points for 535 serial samples from 107 patients by using a virus-like particle-based enzyme-linked immunosorbent assay. Viral DNA in urine and plasma samples was quantitated. The seroconversion rate was 87.5% (14/16); 78.6% (11/14) and 14.3% (2/14) of patients who seroconverted developed viruria and viremia, respectively. Transient seroreversion was observed in 18.7% of patients at 17.4 ± 11.9 weeks posttransplant and was not attributable to loss of antigenic stimulation, changes in immunosuppression, or antiviral treatment. Titers for anti-BK IgG, IgA, and IgM were higher in patients with BKV replication than in those without BKV replication. A rise in the optical density (OD) of anti-BK IgA (0.19), IgM (0.04), or IgG (0.38) had a sensitivity of 76.6 to 88.0% and a specificity of 71.7 to 76.1% for detection of viruria. An anti-BK IgG- and IgA-positive phenotype at week 1 was less frequent in patients who subsequently developed viremia (14.3%) than in those who subsequently developed viruria (42.2%) (P = 0.04). Anti-BK IgG OD at week 1 showed a weak negative correlation with peak urine viral load (r = −0.25; P = 0.05). In summary, serial measurements of anti-BKV immunoglobulin class (i) detect onset of viral replication, (ii) document episodes of seroreversion, and (iii) can potentially provide prognostic information.

Telemedicine for Reach, Education, Access, and Treatment (TREAT): Linking Telemedicine With Diabetes Self-management Education to Improve Care in Rural Communities

Purpose The purpose of this study was to examine diabetes-related behavioral and psychosocial outcomes as well as patient satisfaction with the Telemedicine for Reach, Education, Access, and Treatment (TREAT) model. Methods TREAT employs telemedicine services provided by an endocrinologist at an urban area in partnership with a diabetes educator in a rural area, working together with patients and primary care providers (PCPs). Thirty-five patients with type 2 diabetes were referred by PCPs and received glycemic management and education in the TREAT model. A diabetes educator operated the videoconferencing equipment, remained with the patient to receive and review plan communicated by the endocrinologist during the visit, coordinated services, administered surveys, and provided self-management education and support. Empowerment, self-care, diabetes distress, adherence to monitoring, and patient satisfaction were assessed by survey at baseline and follow-up. Results There was significant improvement in empowerment, self-care (adherence to diet and monitoring), and reduction in diabetes distress. Patients reported high levels of satisfaction. Conclusions In rural areas, the TREAT model delivers improvements in behavioral and psychosocial outcomes and high patient satisfaction. The TREAT model may be a viable option for rural communities that suffer from a shortage of team-based diabetes specialist and self-management support services.

Bone Mineral Density Changes Among Women Initiating Proton Pump Inhibitors or H2 Receptor Antagonists: A SWAN Cohort Study

Proton pump inhibitors (PPIs) have been associated with diminished bone mineral density (BMD) and an increased risk of fracture; however, prior studies have not yielded consistent results, and many have suboptimal ascertainment of both PPI use and BMD. We used data from the Study of Womens Health Across the Nation (SWAN), a multicenter, multi‐ethnic, community‐based longitudinal cohort study of women across the menopause transition to examine the association between annualized BMD changes and new use of PPIs. We compared changes in BMD in new PPI users with changes in BMD in new users of histamine 2 receptor antagonists (H2RAs) and with changes in BMD in subjects who did not use either class of medications. Mixed linear regression models included recognized risk factors for osteoporosis, including demographics, menopausal transition stage, body mass index (BMI), lifestyle factors, as well as comorbidities and concomitant medications. To provide further evidence for the validity of our analytic approach, we also examined the effects of hormone‐replacement therapy (HT), a class of medications that should reduce bone loss, on changes in BMD as an internal positive control group. We identified 207 new users of PPIs, 185 new users of H2RAs, and 1,676 non‐users. Study subjects had a mean age of 50 years and were followed for a median of 9.9 years. Adjusted models found no difference in the annualized BMD change at the lumbar spine, femoral neck, or total hip in PPI users compared with H2RA users or non‐users. These results were robust to sensitivity analyses. BMD increased as expected in HT users, supporting the validity of our study design. These longitudinal analyses plus similar prior studies argue against an association between PPI use and BMD loss.

Who Can Provide Diabetes Self-Management Support in Primary Care? Findings From a Randomized Controlled Trial

Purpose The purpose of this comparative effectiveness study is to compare diabetes self-management support (DSMS) approaches and determine who can be most effective in helping patients maintain/improve clinical outcomes, self-care behaviors, distress, and satisfaction following diabetes self-management education (DSME) delivered in primary care. Methods After receiving DSME, 141 participants were randomized to receive DSMS delivered by a trained supporter: educator, peer, practice staff, or usual education during a 6-month follow-up period. DSMS groups were compared to determine which supporter helped participants to maintain/improve A1C, blood pressure, lipids, weight, self-care, and distress. DSMS satisfaction was also examined. Results There was a significant improvement in A1C, empowerment, aspects of self-care, and distress following DSME at 6 weeks. Those in the educator DSMS group best sustained improved A1C while those in the other DSMS groups maintained glycemic improvements but began to show trends toward worsening. No significant differences or clear trends were seen in other clinical, behavioral, or psychosocial outcomes. The Program Reinforcement Impacts Self-Management (PRISM) study demonstrates that following DSME, participants maintained improved glycemia, lipid, weight, and self-care behaviors and reductions in distress throughout the delivery of DSMS interventions regardless of DSMS supporter. All of the participants reported satisfaction with DSMS. Conclusions These findings reaffirm the critical role of educators but suggest that others may serve as DSMS supporters. Results suggest that DSME delivered in primary care is effective and multiple DSMS agents are reasonable. As patient-centered self-management approaches are being explored in primary care, delivery of DSME and DSMS becomes paramount.

Hepatitis C recurrence is not adversely affected by the use of donation after cardiac death liver allografts

Many factors can worsen a recurrent hepatitis C virus (HCV) infection after liver transplantation (LT). We sought to determine whether the use of donation after cardiac death (DCD) livers affects HCV recurrence. From January 2000 to June 2008, 37 HCV patients underwent LT with DCD allografts. The outcomes and severity of HCV recurrence were analyzed along with those for 74 matched control patients with HCV who received donation after brain death (DBD) livers. The 2 groups had similar donor and recipient characteristics, immunosuppression regimens, rates of acute cellular rejection (ACR), and HCV profiles. DCD patients had a higher incidence of primary nonfunction (19% versus 3%, P = 0.006) and significantly higher peak aspartate aminotransferase levels in comparison with DBD subjects, suggesting a greater degree of ischemia/reperfusion injury. Although the survival rates were not significantly different, DCD recipients had lower 1‐ and 5‐year patient survival rates (83% and 69% versus 84% and 78%, respectively, P = 0.75) and graft survival rates (70% and 61% versus 82% and 74%, respectively, P = 0.24). Three hundred fourteen protocol and clinically indicated liver biopsy procedures were performed within 6 years after transplantation, and mixed modeling analysis showed that fibrosis progression rates were similar for the 2 groups (0.6 fibrosis units/year according to the Ishak modified staging system). The rates of severe HCV recurrence (retransplantation or death due to recurrent hepatitis C and/or the development of stage 4/6 fibrosis or worse within 2 years) were similar [3 DCD patients (8%) versus 11 DBD patients (15%), P = 0.38], and cytomegalovirus infection (hazard ratio = 7.9, P = 0.002, 95% confidence interval = 2.1‐28.9) and ACR (hazard ratio = 6.2, P = 0.002, 95% confidence interval = 2.0‐19.7) were the only independent risk factors for severe recurrence. In summary, although there was a trend of poorer overall outcomes in DCD patients, the use of DCD livers did not appear to adversely affect HCV recurrence after LT. Liver Transpl 16:1288‐1295, 2010.