Benjamin G. Fincke

Angioedema Incidence in US Veterans Initiating Angiotensin-Converting Enzyme Inhibitors

Angioedema is a rare but potentially serious complication of angiotensin-converting enzyme inhibitor (ACE) use. We conducted a study to estimate incidence of ACE-related angioedema and explore its determinants in a large racially diverse patient population. We used linked medical and pharmacy records to identify all patients in the US Veterans Affairs Health Care System from April 1999 through December 2000 who received first prescriptions for antihypertensive medications. We studied 195 192 ACE initiators and 399 889 patients initiating other antihypertensive medications (OAH). New angioedema was identified by diagnosis codes using methods validated in a national sample of 869 angioedema cases with confirmation for over 95% of cases. Overall, 0.20% of ACE initiators developed angioedema while on the medication and the incidence rate was 1.97 (1.77 to 2.18) cases per 1000 person years. This compares with a rate of 0.51 (0.43 to 0.59) in OAH initiators and the adjusted relative risk estimate was 3.56 (2.82 to 4.44). Fifty five percent of cases occurred within 90 days of first ACE use but risk remained elevated with prolonged use, even beyond 1 year. We estimate that 58.3% of angioedema in patients starting antihypertensives was related to ACE. We also found that angioedema rates were nearly 4-fold higher in blacks, 50% higher in women, and 12% lower in those with diabetes. This study provides a reliable estimate of angioedema incidence associated with ACE use in a diverse nontrial patient population, confirming that the incidence is low, but finding substantial variation by race, sex, and diabetes status.

Applications of methodologies of the Veterans Health Study in the VA healthcare system: conclusions and summary.

The Veterans Health Study (VHS) had as its overarching goal the development, testing, and application of patient-centered assessments for monitoring patient outcomes in ambulatory care in large integrated care systems such as the Department of Veterans Affairs (VA). Unlike other previous studies, the VHS has capitalized on rich administrative databases restricted to the VA and linked to patient-centered outcomes. The VHS has developed a comprehensive set of general and disease-specific measures for use by systems of care for ambulatory patients. Chief among these assessments is the Veterans SF-36 Health Survey for measuring health-related quality of life in veteran ambulatory populations. The Veterans SF-36 Health Survey provides the cornerstone for this study and historically has been extensively disseminated and used in the VA with close to 2 million administrations nationally as part of its quality management system. National surveys administered by the VA since 1996 using the Veterans SF-36 Health Survey indicate important regional differences with implications for varying resource needs. Based upon the rich foundation provided by the VHS methodology, the VA has implemented some of these approaches as part of its quality monitoring system and can serve as a model for other large integrated systems of care.

The Interaction of Patient Perception of Overmedication with Drug Compliance and Side Effects

OBJECTIVE: Little is known about the significance of patient-perceived overmedication. We sought to determine its prevalence and relation to medication compliance, adverse drug reactions, health-related quality of life (HRQOL), and burden of illness.DESIGN: Analysis of self-reported questionnaire data.PATIENTS/PARTICIPANT: There were 1,648 participants in a longitudinal study of male veterans.INTERVENTION: Participants listed each of their medications with indication, missed doses, adverse reactions, and whether their amount of medication was “too much, the right amount, or too little.” The survey included questions about medication adherence, “problems with medications,” common symptoms, and screening questions for a number of chronic conditions. We assessed HRQOL with the Multiple Outcomes Study 36-Item Short Form Health Study (SF-36).MEASUREMENTS AND MAIN RESULTS: Of the 1,256 respondents, 1,007 (80%) had taken medication within 4 weeks. Forty (4%) thought they were taking too much. They reported a 1.6-fold increase in prescription medications, a 5–8 fold increase in adverse effects, a 1.5–2 fold decrease in compliance, an increase in each of seven measured symptoms, and a decrease in six of eight SF-36 domains (p<.05 for all comparisons), the exceptions being the mental health and role-emotional scales. There was also a slight increase in the report of any chronic illness (95% vs 86%, p>.05).CONCLUSIONS: Patient perception of overmedication correlates with self-report of decreased compliance, adverse drug reactions, decreased HRQOL, and an increase in symptomatology that is compatible with unrecognized side effects of medication. Such patients warrant careful evaluation.

Assessment of long-term complications due to type 2 diabetes using patient self-report: the diabetes complications index.

This study aims to develop a patient-based measure of the complications of type 2 diabetes that can be used in examining its relationship with health-related quality of life (HRQOL) and utilization of health services. Using questions analogous to those typically employed by clinicians, we developed a 17-item questionnaire to identify prior diagnoses and current symptoms of 6 common complications of type 2 diabetes. We administered it to 419 patients with type 2 diabetes who were part of the Veterans Health Study, a larger prospective investigation of veterans receiving ambulatory care. From the responses, we calculated a simple sum of the 6 complications. We examined the correlation of this Diabetes Complications Index (DCI) with use of diabetes-related medical resources, outpatient doctor visits, HRQOL, duration of diabetes, and the degree to which patients perceived their health to be diminished by diabetes. The DCI was significantly correlated with the degree to which patients perceived their health to be diminished by diabetes (r = 0.35, P = .0001), utilization of diabetes-related resources (model R2 = 0.15, P = .0001), outpatient doctor visits (model R2 = .08, P = .001), and duration of diabetes (r = 0.11, P = .04). It had a good correlation with aspects of HRQOL that reflect physical function when controlling for age and comorbid conditions (model R2 = 0.23, P = .0001). The DCI shows promise as an efficient method for assessing the effects of type 2 diabetes on HRQOL and predicting utilization of medical resources.

Potentially inappropriate prescribing for the elderly: Effects of geriatric care at the patient and health care system level

Background:Many studies have identified patient characteristics associated with potentially inappropriate prescribing in the elderly (PIPE), however, little attention has been directed toward how health care system factors such as geriatric care may affect this patient safety issue. Objective:This study examines the association between geriatric care and PIPE in a community dwelling elderly population. Research Design:Cross-sectional retrospective database study. Subjects:Veterans age ≥65 years who received health care in the VA system during Fiscal Years (FY99-00), and also received at medications from the Veterans Administration in FY00. Measures:PIPE was identified using the Zhan adaptation of the Beers criteria. Geriatric care penetration was calculated as the proportion of patients within a facility who received at least 1 geriatric outpatient clinic or inpatient visit. Analyses:Logistic regression models with generalized estimating equations were used to assess the relationship between geriatric care and PIPE after controlling for patient and health care system characteristics. Results:Patients receiving geriatric care were less likely to have PIPE exposure (odds ratio, 0.64; 95% confidence interval, 0.59–0.73). There was also a weak effect for geriatric care penetration, with a trend for patients in low geriatric care penetration facilities having higher risk for PIPE regardless of individual geriatric care exposure (odds ratio, 1.14; 95% confidence interval, 0.99–1.30). Conclusions:Although geriatric care is associated with a lower risk of PIPE, additional research is needed to determine if heterogeneity in the organization and delivery of geriatric care resulted in the weak effect of geriatric care penetration, or whether this is a result of low power.

Risk-adjusted mortality as an indicator of outcomes: comparison of the Medicare Advantage Program with the Veterans' Health Administration.

Background:The Medicare Advantage Program (MAP) and the Veterans’ Health Administration (VHA) currently provide many services that benefit the elderly, and a comparative study of their risk-adjusted mortality rates has the potential to provide important information regarding these 2 systems of care. Objective:The objective of this retrospective study was to compare mortality rates between the MAP and the VHA after controlling for case-mix differences. Subjects:This study consisted of 584,294 MAP patients and 420,514 VHA patients. Measures:We used the Death Master File to ascertain the vital status of each study subject over approximately 4 years. We used Cox regression models to estimate hazard ratios (HRs) with 95% confidence intervals (CIs) for the MAP compared with VHA patients. Results:The average age for male MAP patients was 73.8 years (±5.6) and for male VHA patients was 74.05 years (±6.3). Unadjusted mortality rates of males for VHA and MAP were 25.7% and 22.8%, respectively, over approximately 4 years (P < 0.0001), respectively. The case-mix of VHA patients, however, was sicker than those from MAP. After adjusting for case-mix, the HR for mortality in the MAP was significantly higher than that in the VHA (HR, 1.404; 95% CI = 1.383–1.426). We obtained similar results when we compared the mortality rates of females for VHA and MAP. Conclusions:After adjusting for their higher prevalence of chronic disease and worse self-reported health, mortality rates were lower for patients cared for in the VHA compared with those in the MAP. Further studies should examine what differences in care structures and processes contribute to lower mortality in the VHA.

Comparison of Health Outcomes for Male Seniors in the Veterans Health Administration and Medicare Advantage Plans

OBJECTIVES To compare the Veterans Health Administration (VHA) with the Medicare Advantage (MA) plans with regard to health outcomes. DATA SOURCES The Medicare Health Outcome Survey, the 1999 Large Health Survey of Veteran Enrollees, and the Ambulatory Care Survey of Healthcare Experiences of Patients (Fiscal Years 2002 and 2003). STUDY DESIGN A retrospective study. EXTRACTION METHODS Men 65+ receiving care in MA (N=198,421) or in VHA (N=360,316). We compared the risk-adjusted probability of being alive with the same or better physical (PCS) and mental (MCS) health at 2-years follow-up. We computed hazard ratio (HR) for 2-year mortality. PRINCIPAL FINDINGS Veterans had a higher adjusted probability of being alive with the same or better PCS compared with MA participants (VHA 69.2 versus MA 63.6 percent, p<.001). VHA patients had a higher adjusted probability than MA patients of being alive with the same or better MCS (76.1 versus 69.6 percent, p<.001). The HRs for mortality in the MA were higher than in the VHA (HR, 1.26 [95 percent CI 1.23-1.29]). CONCLUSIONS Our findings indicate that the VHA has better patient outcomes than the private managed care plans in Medicare. The VHAs performance offers encouragement that the public sector can both finance and provide exemplary health care.

A classification of diabetic foot infections using ICD-9-CM codes: application to a large computerized medical database

BackgroundDiabetic foot infections are common, serious, and varied. Diagnostic and treatment strategies are correspondingly diverse. It is unclear how patients are managed in actual practice and how outcomes might be improved. Clarification will require study of large numbers of patients, such as are available in medical databases. We have developed and evaluated a system for identifying and classifying diabetic foot infections that can be used for this purpose.MethodsWe used the (VA) Diabetes Epidemiology Cohorts (DEpiC) database to conduct a retrospective observational study of patients with diabetic foot infections. DEpiC contains computerized VA and Medicare patient-level data for patients with diabetes since 1998. We determined which ICD-9-CM codes served to identify patients with different types of diabetic foot infections and ranked them in declining order of severity: Gangrene, Osteomyelitis, Ulcer, Foot cellulitis/abscess, Toe cellulitis/abscess, Paronychia. We evaluated our classification by examining its relationship to patient characteristics, diagnostic procedures, treatments given, and medical outcomes.ResultsThere were 61,007 patients with foot infections, of which 42,063 were classifiable into one of our predefined groups. The different types of infection were related to expected patient characteristics, diagnostic procedures, treatments, and outcomes. Our severity ranking showed a monotonic relationship to hospital length of stay, amputation rate, transition to long-term care, and mortality.ConclusionsWe have developed a classification system for patients with diabetic foot infections that is expressly designed for use with large, computerized, ICD-9-CM coded administrative medical databases. It provides a framework that can be used to conduct observational studies of large numbers of patients in order to examine treatment variation and patient outcomes, including the effect of new management strategies, implementation of practice guidelines, and quality improvement initiatives.

Variation in antibiotic treatment for diabetic patients with serious foot infections: A retrospective observational study

BackgroundDiabetic foot infections are common, serious, and diverse. There is uncertainty about optimal antibiotic treatment, and probably substantial variation in practice. Our aim was to document whether this is the case: A finding that would raise questions about the comparative cost-effectiveness of different regimens and also open the possibility of examining costs and outcomes to determine which should be preferred.MethodsWe used the Veterans Health Administration (VA) Diabetes Epidemiology Cohorts (DEpiC) database to conduct a retrospective observational study of hospitalized patients with diabetic foot infections. DEpiC contains computerized VA and Medicare patient-level data for VA patients with diabetes since 1998, including demographics, ICD-9-CM diagnostic codes, antibiotics prescribed, and VA facility. We identified all patients with ICD-9-CM codes for cellulitis/abscess of the foot and then sub-grouped them according to whether they had cellulitis/abscess plus codes for gangrene, osteomyelitis, skin ulcer, or none of these. For each facility, we determined: 1) The proportion of patients treated with an antibiotic and the initial route of administration; 2) The first antibiotic regimen prescribed for each patient, defined as treatment with the same antibiotic, or combination of antibiotics, for at least 5 continuous days; and 3) The antibacterial spectrum of the first regimen.ResultsWe identified 3,792 patients with cellulitis/abscess of the foot either alone (16.4%), or with ulcer (32.6%), osteomyelitis (19.0%) or gangrene (32.0%). Antibiotics were prescribed for 98.9%. At least 5 continuous days of treatment with an unchanged regimen of one or more antibiotics was prescribed for 59.3%. The means and (ranges) across facilities of the three most common regimens were: 16.4%, (22.8%); 15.7%, (36.1%); and 10.8%, (50.5%). The range of variation across facilities proved substantially greater than that across the different categories of foot infection. We found similar variation in the spectrum of the antibiotic regimen.ConclusionsThe large variations in regimen appear to reflect differences in facility practice styles rather than case mix. It is unlikely that all regimens are equally cost-effective. Our methods make possible evaluation of many regimens across many facilities, and can be applied in further studies to determine which antibiotic regimens should be preferred.

Health care resource utilization and expenditures associated with the use of insulin glargine

BACKGROUND Newer insulins, such as long-acting analogues, offer promise of better glycemic control, reduced risk for diabetes complications, and moderation of health care use and costs. OBJECTIVE We studied initiation of insulin glargine to evaluate its association with subsequent health service utilization and estimated expenditures. METHODS Patients of the Veterans Health Administration, US Department of Veterans Affairs (VA) who initiated insulin glargine (n=5064) in 2001-2002 were compared with patients receiving other insulin (n=69,944), matched on prescription month (index date). Inpatient and outpatient VA care in the 12 months after a patients index date was evaluated using Tobit regression, controlling for prior utilization, demographic characteristics, comorbidities, glycosylated hemoglobin (HbA(1c)) levels, and diabetes severity. National average utilization costs and medication acquisition costs were used to estimate the value of VA expenditures. RESULTS Compared with other insulin users, insulin glargine initiators had higher HbA(1c) values (8.72% vs 8.16%) prior to the index date, but greater subsequent HbA(1c) reduction (-0.50% vs -0.22%). After adjustment for age, prior utilization, HbA(1c) levels, and other factors, insulin glargine initiation was associated with 2.4 (95% CI, 1.1-3.7) fewer inpatient days for patients with any hospital admission (US