Association between osteoporosis treatment change and adherence, incident fracture, and total healthcare costs in a Medicare Advantage Prescription Drug plan.

UNLABELLED: We examined the association between osteoporosis treatment change and adherence, incident fractures, and healthcare costs among Medicare Advantage Prescription Drug (MAPD) plan members. Treatment change was associated with a small but significant increase in adherence, but was not associated with incident fracture or total healthcare costs. Overall adherence remained low. INTRODUCTION: We examined the association between osteoporosis treatment change and adherence, incident fractures, and healthcare costs among MAPD plan members in a large US health plan. METHODS: We conducted a retrospective cohort study of MAPD plan members aged≥50 years newly initiated on an osteoporosis medication between 1 January 2006 and 31 December 2008. Members were identified as having or not having an osteoporosis treatment change within 12 months after initiating osteoporosis medication. Logistic regression analyses and difference-in-difference (DID) generalized linear models were used to investigate the association between osteoporosis treatment change and (1) adherence to treatment, (2) incident fracture, and (3) healthcare costs at 12 and 24 months follow-up. RESULTS: Of the 33,823 members newly initiated on osteoporosis treatment, 3,573 (10.6%) changed osteoporosis treatment within 12 months. After controlling for covariates, osteoporosis treatment change was associated with significantly higher odds of being adherent (medication possession ratio [MPR]≥0.8) at 12 months (odds ratio [OR]=1.18) and 24 months (OR=1.13) follow-up. However, overall adherence remained low (MPR=0.59 and 0.51 for the change cohort and MPR=0.51 and 0.44 for the no-change cohort at 12 and 24 months, respectively). Osteoporosis treatment change was not significantly associated with incident fracture (OR=1.00 at 12 months and OR=0.98 at 24 months) or total direct healthcare costs (p>0.4) in the DID analysis, but was associated with higher pharmacy costs (p<0.004). CONCLUSIONS: Osteoporosis treatment change was associated with a small but significant increase in adherence, but was not associated with incident fracture or total healthcare costs in the MAPD plan population. Overall adherence to therapy remained low.

Imputing physical health status scores missing owing to mortality: results of a simulation comparing multiple techniques.

BACKGROUND: Having missing data complicates the statistical analysis of health-related quality-of-life (HRQOL) data and, depending on the extent and nature of missing data, can introduce significant bias in treatment comparisons. OBJECTIVE: We evaluated the bias associated with 4 different imputation methods for estimating physical health status (PHS) scores missing as a result of mortality. METHODS: A simulation study was conducted in which we systematically varied mortality rates from 0% to 30% and change in PHS scores from -20 to 20 on a 100-point scale for a 2-group clinical trial with follow-up over 18 months. The 4 imputation methods were last value carried forward (LVCF), arbitrary substitution (ARBSUB), empirical Bayes (BAYES), and within-subject modeling (WSMOD). Pseudo-root mean square residuals (RMSRs) and differences between true and estimated slopes were used to evaluate how well the imputation methods reproduced the true characteristics of the simulated population data. RESULTS: ARBSUB and BAYES methods have the smallest RMSRs compared with LVCF and WSMOD across all mortality rates. As the rate of missing data resulting from mortality increased, all imputation techniques deviated more from population data. The BAYES technique was best at reproducing group slopes in cases with differential mortality rates or when mortality rates exceeded 15%. WSMOD and LVCF significantly underestimated changes in PHS. CONCLUSIONS: The different imputation methods produced comparable results when there were few missing data. The BAYES approach most closely estimated true population differences and change in PHS regardless of missing data rates. These findings are limited to physical health and functioning measures.

Development of subscales from the symptoms/problems and effects of kidney disease scales of the kidney disease quality of life instrument.

BACKGROUND: The Kidney Disease Quality of Life Instrument (KDQOL) was developed to provide clinicians with a comprehensive assessment of the important domains of health-related quality of life (HRQOL) for patients with end-stage renal disease who are undergoing hemodialysis. OBJECTIVE: The purpose of this study was to develop subscales from the 55 items comprising the Symptoms/Problems and Effects of Kidney Disease scales of the KDQOL and to measure the internal consistency reliability of these subscales. METHODS: The 55 items from the Symptoms/Problems and Effects of Kidney Disease scales were arranged into substantively meaningful clusters using an affinity mapping procedure. The resulting subscales were assessed for internal consistency reliability using data from a sample of 165 individuals with kidney disease who had completed the KDQOL. RESULTS: Eleven multi-item subscales were identified: pain, psychological dependency, cognitive functioning, social functioning, dialysis-related symptoms, cardiopulmonary symptoms, sleep, energy, cramps, diet, and appetite. Four items (clotting or other problems with access site, high blood pressure, numbness in hands or feet, and blurred vision) were not included in any of these subscales. Internal consistency reliability estimates for the 11 subscales ranged from 0.66 to 0.92. These subscales correlated with the scales from the 36-Item Short-Form Health Survey as hypothesized (ie, corresponding pain, energy, and social functioning scales had the highest correlations). In addition, several subscales were significantly associated, as hypothesized, with other variables such as the number of disability days. CONCLUSIONS: The results of this study further support the reliability and validity of the KDQOL. The 11 subscales identified yield more detailed information on the HRQOL of patients with kidney disease and provide a basis for specific improvements in the quality of care delivered to these patients.

Providing managed care options for a large population: evaluating the CHAMPUS reform initiative. Civilian Health and Medical Program of the Uniformed Services.

OBJECTIVES: To evaluate a managed care demonstration project in CHAMPUS (Civilian Health and Medical Program of the Uniformed Services), the insurance program covering physical and mental health care services for the dependents of active duty military personnel, military retirees, and the retirees' dependents. The demonstration project added a health maintenance organization (HMO) option and a preferred provider organization (PPO) option to the standard CHAMPUS coverage and allowed beneficiaries to select the coverage option they preferred. DATA SOURCES: Utilization, costs, access, and beneficiary satisfaction were measured using data from CHAMPUS claims records, the Defense Enrollment Eligibility Reporting System, the demonstration project contractor's HMO enrollment file, the contractor's list of network hospitals, and two surveys of CHAMPUS beneficiaries. STUDY DESIGN: Changes in utilization at 11 demonstration sites were compared with changes in utilization at 11 matched control sites. The effect of the demonstration project on costs was evaluated by estimating the costs for the demonstration sites both with and without the managed care options based on data from the control sites. Access to care and satisfaction were compared between the demonstration sites and control sites based on beneficiary surveys. DATA COLLECTION: All claims in both demonstration and control sites were used in estimating utilization changes. Two mailed surveys were sent to a randomly selected sample of active duty and retiree households with CHAMPUS beneficiaries; the sample was stratified by beneficiary type (active duty or retiree) and site. PRINCIPLE FINDINGS: Overall utilization in the CHAMPUS system decreased at the demonstration sites but stayed approximately the same at the control sites. Utilization among the enrollees in the HMO demonstration option, however, increased dramatically. Patient access to care and satisfaction generally remained at the same levels at both demonstration and control sites, but enrollees in the HMO option reported higher satisfaction. Costs to the government at the demonstration areas, based on regression estimates from the control sites, were about the same or slightly higher than what they would have been under the standard CHAMPUS system. CONCLUSIONS: Managed care plans for large government-sponsored insurance programs can reduce utilization and maintain patient access and satisfaction. Careful structuring of such plans is needed, however, if they are to reduce costs.

A review of health-related quality-of-life measures used in end-stage renal disease.

Health-related quality of life (HRQOL) is a critical issue in the treatment of end-stage renal disease (ESRD) patients. The variety of symptoms, comorbidities, and treatments of ESRD over the course of its chronic disease trajectory necessitate comprehensive assessment of the impact of interventions on HRQOL. A literature review of ESRD HRQOL studies was performed to provide an overview of the instruments used and to provide recommendations for HRQOL assessment in future studies. Instruments were classified based on the health domains they assess and whether they are generic or disease targeted. The instruments were judged in terms of their comprehensiveness, reliability, and validity.

Modified capitation and treatment incentives for end stage renal disease.

This study developed a modified capitation payment method for the Medicare end stage renal disease (ESRD) program designed to support appropriate treatment choices and protect health plans from undue financial risk. The payment method consists of risk-adjusted monthly capitated payments for individuals on dialysis or with functioning kidney grafts, lump sum event payments for expected incremental costs of kidney transplantations or graft failures, and outlier payments for expensive patients. The methodology explained 25 percent of variation in annual payments per patient. Risk adjustment captured substantial variations across patient groups. Outlier payments reduced health plan risk by up to 15 percent.

Dissemination of effectiveness and outcomes research.

Effectiveness and outcomes research seeks to improve patients' health outcomes by improving the quality of the health care they receive. Dissemination of the findings of such research is a necessary step in that process. This paper reviews what is known about designing and disseminating effective information packages aimed at health care providers (mainly physicians), where effectiveness means promoting behavior change on the part of practitioners that leads to better patient care. Practice-relevant research information is delivered to providers through publication of results from randomized clinical trials, dissemination of consensus recommendations, development and use of computer-based aids to clinical decision making, and provision of continuing medical education. Each of these areas offers numerous examples of the exceedingly modest behavioral response that can be expected from the mere provision of information. The literature also offers some principles that may improve the chances for success, including the desirability of techniques that involve face-to-face interaction, promoting the active involvement of the learner, repeating the message, making recommendations explicit and relevant to clinical practice, and making use of opinion leaders and peer influence. Little basic research has been done on providers' motivations and actual decision-making processes. Research aimed at furthering a behavioral science of providers could yield new insights on effective dissemination strategies as well.

Development of the kidney disease quality of life (KDQOL) instrument.

This paper describes the Kidney Disease Quality of Life (KDQOL) Instrument (dialysis version), a self-report measure that includes a 36-item health survey as the generic core, supplemented with multi-item scales targeted at particular concerns of individuals with kidney disease and on dialysis (symptom/problems, effects of kidney disease on daily life, burden of kidney disease, cognitive function, work status, sexual function, quality of social interaction, sleep). Also included were multi-item measures of social support, dialysis staff encouragement and patient satisfaction, and a single-item overall rating of health. The KDQOL was administered to 165 individuals with kidney disease (52% female; 48% male; 47% White; 27% African-American; 11% Hispanic; 8% Asian; 4% Native American; and 3% other ethnicities), sampled from nine different outpatient dialysis centres located in Southern California, the Northwest, and the Midwest. The average age of the sample was 53 years (range from 22 to 87), and 10% were 75 years or older. Internal consistency reliability estimates for the 19 multi-item scales exceeded 0.75 for every measure except one. The mean scores for individuals in this sample on the 36-item health scales were lower than the general population by one-quarter (emotional well-being) to a full standard deviation (physical function, role limitations due to physical health, general health), but similar to scores for dialysis patients in other studies. Correlations of the KDQOL scales with number of hospital days in the last 6 months were statistically significant (p < 0.05) for 14 of the 19 scales and number of medications currently being taken for nine of the scales. Results of this study provide support for the reliability and validity of the KDQOL.

The effect of DR antigens, race, sex, and peak PRA on estimated median waiting time for a first cadaver kidney transplant.

1. Fifty-six DR phenotypes account for 95% of the population waiting for a transplant and who have received a transplant. There are 15 pairs that account for 46% of the population. Large differences in the distribution of DR phenotypes between the races were observed. 2. There do not appear to be significant differences among the 15 DR phenotypes in the rate of transplantation. There are, however, significant differences in the median waiting time to a first cadaver kidney transplant across the 15 DR phenotypes. 3. Blacks are not being transplanted in proportion to their numbers on the list of those awaiting a transplant. Blacks represent approximately 27% of the population waiting for a transplant, but represent only 22.6% of the population which receives a first cadaver kidney transplant. 4. The estimated median waiting time for Blacks is almost twice that of Whites. When age, peak PRA, DR phenotype, blood type, and sex are controlled, Blacks, when compared to Whites, are still 18% less likely to receive a first cadaver kidney transplant at any point in time.