Cost-related immunosuppressive medication nonadherence among kidney transplant recipients.

BACKGROUND AND OBJECTIVES: Immunosuppressive medications are essential in preventing kidney transplant rejection. Continuous insurance coverage for outpatient immunosuppressive medications remains a major issue. The objective of this study was to establish the prevalence and consequences of cost-related immunosuppressive medication nonadherence. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A descriptive survey of all U.S. kidney transplant programs (n = 254) was conducted. The response rate for the survey exceeded 99%. The main outcome measures included the following: transplant recipient concerns related to medication costs, ability to pay for medications, medication nonadherence and its consequences, and failure of transplant centers to place patients on the transplant waiting list. RESULTS: Continuous insurance coverage for outpatient immunosuppressive drugs is a problem having potentially grave consequences for the majority of kidney transplant recipients. More than 70% of kidney transplant programs report that their patients have an extremely or very serious problem paying for their medications. About 47% of the programs indicate that more than 40% of their patients are having difficulty paying for their immunosuppressive medications. In turn, 68% of the programs report deaths and graft losses attributable to cost-related immunosuppressive medication nonadherence. Some of the problems identified here are more significant for adult than pediatric patients. CONCLUSIONS: The prevalence and consequences of cost-related immunosuppressive medication nonadherence among kidney transplant recipients have now been documented. The results presented here should serve as the necessary impetus for the development of health care policies supporting Medicare coverage of immunosuppressive medications for the life of the transplanted kidney.

Psychometric evaluation of the National Kidney Dialysis and Kidney Transplantation Study symptom checklist: reliability and validity.

BACKGROUND: Patient-reported outcomes (PROs) are critical in the evaluation of treatment effectiveness. The National Kidney Dialysis and Kidney Transplantation Study (NKDKTS) symptom checklist was developed in the 1980s as a means to better understand the relationships amongst end-stage renal disease (ESRD), anaemia symptoms and multiple quality of life indicators. Unfortunately, key components of validity and reliability were not established at the time of the study. The present study helps fill this void by evaluating the psychometric properties of the 13-item NKDKTS symptom checklist, a measure of anaemia symptom frequency, in a dialysis population. METHODS: The NKDKTS symptom checklist was administered to 104 dialysis patients in three dialysis units at baseline, 48 h and 7 days. Internal consistency, test-retest reliability and construct validity via known-groups responsiveness were evaluated. RESULTS: Principal components factor analyses produced a single factor at each time point, with all items loading >0.50 across time points, and accounting for 37%, 44% and 46% of the variance at each time point (respectively). Forcing a 2-factor solution across time points yielded a single instance of an item loading more highly on factor 2 (0.57) than on factor 1 (0.53). Internal consistency was good at all three time points (Cronbach's alpha = 0.86, 0.89 and 0.90, respectively). Known-groups validity was evaluated by examining the symptom scores of subjects categorized by haemoglobin level. Subjects with lower haemoglobin levels reported significantly more symptoms, and the point estimates and variance at each haemoglobin level were stable over time. CONCLUSION: The results of this study provide further evidence supporting the validity and reliability of the NKDKTS symptom checklist.

The economic implications of noninvasive molecular testing for cardiac allograft rejection.

Endomyocardial biopsy is the mainstay for monitoring cardiac allograft rejection. A noninvasive strategy--peripheral blood gene expression profiling of circulating leukocytes--is an alternative with proven benefits, but unclear economic implications. Financial data were obtained from five cardiac transplant centers. An economic evaluation was conducted to compare the costs of outpatient biopsy with those of a noninvasive approach to monitoring cardiac allograft rejection. Hospital outpatient biopsy costs averaged 3297 US dollars, excluding reimbursement for professional fees. Costs to Medicare and private payers averaged 3581 US dollars and 4140 US dollars, respectively. A noninvasive monitoring test can reduce biopsy utilization. The savings to health care payers in the United States can be conservatively estimated at approximately 12.0 million US dollars annually. Molecular testing using gene expression profiling of peripheral circulating leukocytes is a new technology that offers physicians a noninvasive, less expensive alternative to endomyocardial biopsy for monitoring allograft rejection in cardiac transplant patients.

Effect of exercise treadmill testing and stress imaging on the triage of patients with chest pain: CHEER substudy.

OBJECTIVE: To determine whether stress imaging for patients who are unsuitable for exercise treadmill testing (ETT) as part of a chest pain unit (CPU) triage strategy resulted in incremental benefit in clinical outcomes and relative costs compared with patients randomized to routine hospital admission. PATIENTS AND METHODS: Clinical outcomes and medical resource utilization were examined at the Mayo Clinic in Rochester, Minn, for 212 intermediate-risk patients with unstable angina randomized to a CPU and compared with 212 patients randomized to routine admission from November 21, 1995, to March 18, 1997. Patients in stable condition in the CPU underwent ETT; if patients were unsuitable for ETT, stress imaging was performed. Costs for CPU evaluation and outcomes were assessed during a 6-month follow-up. RESULTS: During the observation period, 60 patients (28%) were admitted to the hospital. Of the 152 remaining patients, 125 (82%) underwent ETT (91 had normal results), and 27 (18%) underwent stress imaging (3 had normal results). Patients with normal ETT or stress imaging results had no primary events at 6-month follow-up. Patients admitted to the hospital who underwent stress imaging had an insignificantly higher 6-month event rate compared with patients who underwent ETT (16.7% vs 8.1%; P=.38). The standardized resource-based relative-value units (RBRVUs) for patients who underwent ETT and stress imaging during follow-up were 19.4 and 56.4 RBRVUs, respectively, compared with 51.4 (ETT) and 52.1 (stress imaging) RBRVUs for similar numbers of patients randomized to routine admission. CONCLUSIONS: Exercise treadmill testing safely stratified most intermediate-risk patients with unstable angina and was less costly than routine admission. Patients not suitable for ETT are likely to have abnormal stress imaging results. They represent a higher-risk cohort that could be routinely admitted to the hospital without reducing the effectiveness of the CPU strategy.

Vital role of medical examiners and coroners in organ transplantation.

Many people die owing to the shortage of donor organs. Medical examiners and coroners (MEs/Cs) play a vital role in making organs available for potential recipients. Medical examiners'/coroners' case data were collected using a structured confirmatory-recorded methodology for calendar years 2000-01 and were linked and analyzed with donor and transplant data from the United Network for Organ Sharing, predicting the nature and extent of the loss of donor organs. Nearly seven percent of ME/C cases were denied recovery during 2000-01. Because 353 and likely, 411 potential organ donors (PODs) were denied, as many as 1400 persons on transplant waiting lists did not receive organs because of ME/C denials. Problematically for pediatric patients awaiting transplantation, nearly half of all ME/C denials occurred in pediatric patients. Eighteen percent of PODs aged five or less and 44.2% of child abuse PODs were denied recovery by the ME/C. There were no (zero) denials in three of the five largest U.S. cities and in four states. Since 1994, two states have enacted legislation restricting the circumstances of ME/C denials, resulting in an 83% decrease in ME/C denials. Release of all organs from ME/C cases is needed urgently to protect the lives of those persons awaiting transplantation. Medical examiners and coroners deserve recognition for their efforts in advocating methods and/or regulation/legislation designed to achieve 100% release of life-saving organs for transplantation.