A Medication Adherence Promotion System to Reduce Late Kidney Allograft Rejection: A Quality Improvement Study.

RATIONALE & OBJECTIVE: Adolescent and young adult kidney transplant recipients have a high risk of rejection related to suboptimal adherence. Multicomponent interventions improve adherence in controlled trials, but clinical implementation is lacking. We describe an initiative to reduce allograft rejection using evidence-based adherence promotion strategies. STUDY DESIGN: Interrupted time series. SETTING & PARTICIPANTS: Kidney transplant recipients cared for at Cincinnati Children's Hospital ≥ 1 year after transplant and taking ≥1 immunosuppressive medication(s) from 2014 through 2017. QUALITY IMPROVEMENT ACTIVITIES: The following interventions, collectively called MAPS (Medication Adherence Promotion System), were implemented over 14 months: (1) adherence promotion training for clinical staff, 2) electronic health record-supported adherence risk screening, (3) systematic assessment of medication adherence barriers, (4) designation of specific staff to address adherence barriers, (5) shared decision-making with the patients to overcome adherence barriers, (6) follow-up evaluation to assess progress, and (7) optional electronic medication monitoring. OUTCOMES: Primary Outcome: Late acute rejection. Process measures were conducted to assess barriers, identify barriers, and perform interventions. The secondary outcomes/balancing measures were de novo donor-specific antibodies (DSA), biopsy rate, and rejections per biopsy. ANALYTICAL APPROACH: Time series analysis using statistical process control evaluated patient-days between acute rejections as well as monthly rejections per 100 patient-months before and after implementation. To control for known rejection risk factors including changes in treatment and case mix, multivariable analyses were performed. RESULTS: The monthly rejection rate fell from 1.61 rejections per 100 patient-months in the 26 months before implementation to 0.88 rejections per 100 patient-months in the 22 months after implementation. In the multivariable analysis, MAPS was associated with a 50% reduction in rejection incidence (incidence rate ratio, 0.50 [95% CI, 0.27-0.91]; P = 0.02). DSA and time since transplant (per each additional year) were also associated with rejection incidence (incidence rate ratio, 2.27 [P = 0.02] and 0.87 [P = 0.02], respectively). LIMITATIONS: Single-center study, and potential confounding by unmeasured variables. CONCLUSIONS: Clinical implementation of evidence-based adherence-promotion strategies was associated with a 50% reduction in acute rejection incidence over 2 years.

Assessment of a Day Hospital Management Program for Children With Type 1 Diabetes.

Importance: A shift in the setting of care delivery for children with a new diagnosis of type 1 diabetes led to a reorganization of treatment. Objective: To determine whether a new diagnosis of pediatric diabetes can be successfully managed in a day hospital model. Design, Setting, and Participants: This quality improvement study used retrospectively collected data on pediatric patients with a new diagnosis of diabetes who completed an inpatient program for education and insulin titration prospectively compared with patients completing a diabetes day hospital program. Baseline data were collected over 12 months (January-December 2015) and intervention data collected over 14 months (March 2016-May 2017). The study was conducted at a single institution and judged as a nonhuman participant project. The referral local base included a 100-mile radius. Patient inclusion was a new diagnosis of diabetes, age 5 years or older, and no biochemical evidence of diabetic ketoacidosis. Ninety-six patients completed the day hospital program and 192 patients completed an inpatient program. Exposures: All patients received 2 consecutive days of insulin titration and education in either a day hospital or inpatient setting. Main Outcomes and Measures: Primary outcomes included the mean length of stay, patient charge, and insurance denial/reimbursement rates. The hypothesis was that a day hospital program would be associated with a reduced length of stay, which would directly affect patient charges and insurance denials. Results: Among the 96 day hospital patients, the mean (SD) age was 12.2 (4.7) years (range 5-20.3), with no patients experiencing diabetic ketoacidosis or hypernatremia. Among the 192 inpatient patients, the mean (SD) age was 9.4 (4.7) years (range, 1.6-20.1). The mean (SD) length of stay reduction in the day hospital was 46 (14.1) to 14 (5.1) hours. The mean day hospital patient charge was $2800, compared with a mean (SD) baseline carge of $24 103 ($9401). Within the first year, there was a cumulative reduction in patient charges of more than $2.1 million. Conclusions and Relevance: This study's findings suggest that a diabetes day hospital setting was associated with reductions in length of stay and patient charges, with an increase in insurance reimbursements and a decrease in insurance denials. This study demonstrates an effective way to streamline new-onset diabetes education, which may reduce length of stay and patient charges. Reimbursement rates for patients with a new diagnosis of diabetes increased from 52% to 72% and reimbursement denial rates decreased from 80% to 0%.

Nonparametric regression of state occupation, entry, exit, and waiting times with multistate right-censored data.

We construct nonparametric regression estimators of a number of temporal functions in a multistate system based on a continuous univariate baseline covariate. These estimators include state occupation probabilities, state entry, exit, and waiting (sojourn) time distribution functions of a general progressive (e.g., acyclic) multistate model. We subject the data to right censoring, and the censoring mechanism is explainable by observable covariates that could be time dependent. The resulting estimators are valid even if the multistate process is non-Markov. We study the performance of the estimators in two simulation settings. We establish large sample consistency of these estimators. We illustrate our estimators using a data set on bone marrow transplant recipients.

Prophylaxis against de novo hepatitis B for liver transplantation utilizing hep B core (+) donors: does hepatitis B immunoglobulin provide a survival advantage?

Donor liver allografts with positive serology for hepatitis B core antibody [HBc (+)] have been increasingly used for liver transplantation. However, the optimal prophylactic regimen to prevent development of de novo hepatitis B has not been determined. To evaluate this, we screened United Network for Organ Sharing (UNOS) Standard Transplant Analysis and Research (STAR) registry data for adult recipients of HBc (+) organs who were HBsAg (-), and evaluated the effects of using prophylactic anti-viral therapies (HBIG and lamivudine) on patient and graft survival. Out of a total cohort of 958 patients transplanted since 2004, 61 received HBIG alone, 116 received lamivudine alone, 66 both, 509 neither and 206 were missing this information. Based on several multivariable Cox regression models, patients receiving HBIG therapy-only were observed to have a statistically significant (approximately 70%) reduction in risk of mortality compared with patients receiving lamivudine-only therapy [HR=0.29, 95% CI (0.10, 0.86), P=0.026], and a nonstatistically significant reduction in risk of graft failure. However, no graft failures were attributed to de novo hepatitis B, suggesting that any improved graft/patient survival possibly associated with HBIG therapy occurs independently of de novo hepatitis B virus (HBV) reduction. While this study cannot prove that HBIG therapy is protective for graft and patient survival after liver transplantation, these findings do highlight the need to further examine and study prophylactic use in recipients of HBc (+) donors.

Triceps skinfold thickness centile charts in primary school children in Shiraz, Iran.

Triceps skinfold thickness charts of a random sample of 2,234 healthy school children (1,161 boys and 1,073 girls) in Shiraz, Iran are presented. Triceps skinfold thickness increases by age and is higher in girls than boys, except for upper extreme centiles. Triceps skinfold thickness may be used with reasonable success to detect childhood obesity, which would be of great importance in public health promotion. It favors adequacy and simplicity in screening for adiposity. The charts presented here are likely to be applied to urban population of school-aged children in Iran, however, it should be updated periodically.