Rajesh Balkrishnan

Better medication adherence results in greater improvement in severity of psoriasis

Background  Patients are commonly nonadherent to medication regimens. In dermatology, there has been little study of the effect of nonadherence on outcomes.

Development and Validation of the Insulin Treatment Satisfaction Questionnaire

BACKGROUND Treatment of diabetes mellitus (DM) is complex, requiring multifaceted lifestyle change or regulation and, for many, self-regulation of insulin levels in the blood. Historically, daily insulin treatment has been viewed as burdensome to patients, prompting newer formulations and improved delivery methods. OBJECTIVE This multicenter, clinical study was designed to develop a conceptually sound, clinically meaningful, and psychometrically valid measure of insulin treatment satisfaction, applicable to a wide range of insulin therapies. METHODS A 3-phase iterative process was employed to develop and validate the Insulin Treatment Satisfaction Questionnaire (ITSQ): (1) conceptual development of items, (2) preliminary validation among patients with DM, and (3) confirmatory validation among patients with DM. RESULTS The ITSQ was validated with 170 patients in phase 2 and 402 patients in phase 3. Confirmatory factor analysis produced a 5-factor, 22-item instrument assessing regimen inconvenience, lifestyle flexibility, glycemic control, hypoglycemic control, and satisfaction with the insulin delivery device. Results for reliability and construct validity of the final version were consistent in both samples of patients treated with insulin, with different data collection methods. Internal consistency (using Cronbach alpha coefficient) of the subscales ranged from 0.79 to 0.91. Test-retest reliability (using Spearman rank correlation coefficients) ranged from 0.63 to 0.94. ITSQ scores showed moderate to high correlation with related measures of treatment burden. The ITSQ differentiated among insulin delivery methods, glycosylated hemoglobin values, the number of times the patient required assistance administering insulin, and insulin adherence. CONCLUSION In our study samples, the ITSQ appeared to be conceptually and psychometrically sound and applicable to a wide range of insulin therapies.

Orthotopic liver transplantation for biliary atresia: The U.S. experience

Biliary atresia is the most common indication for orthotopic liver transplantation (OLT) in the pediatric population. The outcomes of liver transplantation for biliary atresia, however, have not been formally examined on a national scale. The objective of this study was to identify pretransplant variables that predict patient survival after primary liver transplantation for biliary atresia. A cohort of 1,976 pediatric patients undergoing primary liver transplantation for biliary atresia between 1/1988 to 12/2003 was enrolled from the United Network for Organ Sharing database after excluding patients with a history of multiorgan transplant or previous liver transplant. Follow‐up data up to 16 years post‐OLT was available. The 5‐ and 10‐year actuarial survival rates of patients that underwent liver transplantation for biliary atresia in the United States are 87.2% and 85.8%, respectively, and the 5‐ and 10‐year graft actuarial survival rates are 76.2% and 72.7%, respectively. Early deaths (≤90 days post‐OLT) were more often caused by graft failure (P = 0.01), whereas late deaths (>90 days post‐OLT) were more often due to malignancy (P < 0.01). An analysis of outcomes over time demonstrated a decrease in post‐OLT survival and an increase in the number of OLTs done for biliary atresia at an increasing number of centers. A multivariate analysis revealed that cadaveric partial/reduced liver grafts, a history of life support at the time of OLT, and decreased age were independent predictors of increased post‐OLT mortality. In conclusion, OLT is an effective treatment for biliary atresia. Certain pretransplant variables may help predict patient survival following liver transplantation for biliary atresia. (Liver Transpl 2005;11:1193–1200.)

Risk stratification of adult patients undergoing orthotopic liver transplantation for fulminant hepatic failure.

Background. Orthotopic liver transplantation (OLT) is an effective treatment for fulminant hepatic failure (FHF), but postOLT mortality is higher for patients with FHF than for patients with other indications for OLT. In the current study, a large cohort of patients who underwent OLT for FHF was evaluated to develop and validate a system useful for estimating postOLT patient survival. Methods. The 1,457 patients who underwent OLT for FHF in the United States between 1988 and 2003 were enrolled through the UNOS database. This group was divided into a modeling group (n=972) and a crossvalidation group (n=486). With a multivariate regression analysis, the modeling group was used to identify clinical parameters that had a significant association with postOLT survival. This regression analysis was used to create a scoring system that was subsequently assessed in the crossvalidation group. Results. Four risk factors were identified with the multivariate analysis: 1) body mass index ≥30 kg/m2; 2) serum creatinine >2.0 mg/dL; 3) recipient age >50 years old; and 4) history of life support. By assigning points based on the number of risk factors present, the scoring system was able to differentiate between low-risk patients (5-year survival, 81%) and high-risk patients (5-year survival, 42%). The relative risk of postOLT mortality increased by approximately 150% for each additional point. Conclusion. The scoring system risk-stratified the crossvalidation group and accurately predicted postOLT survival. A scoring system utilizing clinical and demographic information readily available prior to OLT may help predict the probability of survival after OLT for FHF.

Hydroxyurea adherence and associated outcomes among Medicaid enrollees with sickle cell disease.

While laboratory and clinical benefits of hydroxyurea for patients with sickle cell disease (SCD) are well‐established, few data describe the extent and implications of non‐adherence. We sought to assess adherence to hydroxyurea among patients with SCD and investigate associations between adherence and clinical and economic outcomes. Insurance claims of North Carolina Medicaid enrollees (6/2000‐8/2008) with SCD were analyzed. Inclusion criteria included age <65 years, continuous Medicaid enrollment ≥12 months before and following hydroxyurea initiation, and ≥2 hydroxyurea prescriptions. Three hundred twelve patients, mean age 21 (±12.2) years, met inclusion criteria and 35% were adherent, defined as a medication possession ration (MPR) ≥ 0.80; mean MPR was 0.60. In the 12 months following hydroxyurea initiation, adherence was associated with reduced risk of SCD‐related hospitalization (hazard ratio [HR] = 0.65, p = .0351), all‐cause and SCD‐related emergency department visit (HR = 0.72, p = .0388; HR = 0.58, p =.0079, respectively), and vaso‐occlusive event (HR = 0.66, p = .0130). Adherence was associated with reductions in health care costs such as all‐cause and SCD‐related inpatient (−

Topical drug delivery systems in dermatology: a review of patient adherence issues

5,286, p < .0001; −

Racial/Ethnic Disparities in Emergency Department Waiting Time for Stroke Patients in the United States

4,403, p < .0001, respectively), ancillary care (−

Medication-related predictors of health-related quality of life in glaucoma patients enrolled in a medicare health maintenance organization

1,336, p < .0001; −

Effect of injury severity on the incidence and utilization-related outcomes of venous thromboembolism in pediatric trauma inpatients.

836, p < .0001, respectively), vaso‐occlusive event‐related (−

Health-related quality of life after pancreatic islet transplantation: a longitudinal study.

5,793, p < .0001), and total costs (−