Evaluation of an Ongoing Diabetes Group Medical Visit in a Family Medicine Practice.

PURPOSE: Group medical visits (GMVs), which combine 1-on-1 clinical consultations and group self-management education, have emerged as a promising vehicle for supporting type 2 diabetes management in primary care. However, few evaluations exist of ongoing diabetes GMVs embedded in medical practices. METHODS: This study used a quasi-experimental design to evaluate diabetes GMV at a large family medicine practice. We examined program attendance and attrition, used propensity score matching to create a matched comparison group, and compared participants and the matched group on clinical, process of care, and utilization outcomes. RESULTS: GMV participants (n = 230) attended an average of 1 session. Participants did not differ significantly from the matched comparison group (n = 230) on clinical, process of care or utilization outcomes. CONCLUSIONS: The diabetes GMV was not associated with improvements in outcomes. Further studies should examine diabetes GMV implementation challenges to enhance their effectiveness in everyday practice.

Perceived or actual barriers to warfarin use in atrial fibrillation based on electronic medical records.

Compared with usual practice, clinical trials often exclude patients with relative contraindications. A study of real-world warfarin use could help inform trials of new medications that could potentially replace warfarin. The objective of this study was to describe potential barriers to warfarin use among patients with atrial fibrillation. This was a retrospective study of electronic medical records (1998-2007) from an inner-city public hospital and affiliated primary care clinics and included adults aged 18 years or more with atrial fibrillation. Exclusions included mitral or aortic valve replacement, hyperthyroidism, or no clinical encounter within 1 year after first diagnosis. Warfarin exposure was defined by electronic pharmacy or physician order data or, in a second definition, international normalized ratio > 1.3. A history of potential barriers to warfarin was defined by International Classification of Diagnoses, 9th revision codes or electronic medical record "dictionary" terms. Among 3329 patients, CHADS2 scores were 0 (17%), 1 (26%), 2-6 (57%). Among 1276 patients with CHADS2 scores >0 who were prescribed warfarin, rates of potential barriers to warfarin were gastrointestinal or genitourinary hemorrhage (20%), alcohol abuse (16%), renal insufficiency (15%), predisposition to falls (8%), cirrhosis/hepatitis (5%), intracranial hemorrhage (1%), other hemorrhage (6%), and age 75 years or more (23%). Among 1475 patients with CHADS2 scores >0 who were not prescribed warfarin, these rates differed by not >3% except for predisposition to falls (16%) and age 75 years or more (43%). In real-world practice, many patients given warfarin have contraindications that would exclude them from clinical trials, and many patients apparently eligible for warfarin do not receive it.

Cost-effectiveness of clopidogrel plus aspirin versus aspirin alone for secondary prevention of cardiovascular events: results from the CHARISMA trial.

OBJECTIVE: To determine the incremental cost-effectiveness of clopidogrel plus aspirin (C + A) compared with aspirin (A) alone during the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA) trial from a US payer perspective. BACKGROUND: Although the CHARISMA trial did not find a benefit of adding clopidogrel to aspirin in its overall study cohort, a benefit was suggested in a prespecified subgroup of patients with established cardiovascular (CV) disease. The cost-effectiveness of dual antiplatelet therapy in this population is unknown. METHODS: Medical resource utilization was assessed prospectively, and costs for hospitalizations, physician services, outpatient care, and medications were assigned using 2007 US dollars. Life expectancy was estimated contingent on fatal and nonfatal CV events using statistical models of long-term survival from the Saskatchewan Health database. RESULTS: C + A was associated with a 12.5% relative reduction in CV death, myocardial infarction, or stroke compared with A alone (6.9% vs. 7.9%, P = 0.048) over a median 28 months of follow-up. Severe or moderate bleeding events were higher in patients receiving C + A versus A alone (3.6% vs. 2.5%, P < 0.001). Mean cost/patient was $2607 higher for C + A, while projected life expectancy increased by an average of 0.072 years due to fewer in-trial events. The resulting incremental cost-effectiveness ratio (ICER) for C + A was $36,343/year of life gained. Findings were insensitive to discount rate, life expectancy projections, post-event costs, and indirect costs from lost productivity; the ICER was most sensitive to the cost of clopidogrel. Bootstrap analysis demonstrated that the ICER for C + A remained <$50,000/life-year gained in 70.6% of bootstrap replicates and <$100,000/life-year gained in 87.4%. CONCLUSIONS: Among patients with established CV disease, adding clopidogrel to aspirin appears to increase life expectancy modestly at a cost generally considered acceptable within the US health-care system.

One-year costs in patients with a history of or at risk for atherothrombosis in the United States.

BACKGROUND: Atherothrombosis is the underlying cause of cardiovascular, cerebrovascular, and peripheral arterial disease and is the leading cause of death in the industrialized world. The objectives of the present study are (1) to examine the annual costs associated with vascular events and interventions that require hospitalization, as well as long-term medication use for the management of associated risk factors, in a US population of outpatients with multiple atherothrombotic risk factors or a history of symptomatic disease and (2) to compare costs across patient subgroups defined according to specific arterial bed(s) affected and the number of affected arterial beds. METHODS AND RESULTS: The international REduction of Atherothrombosis for Continued Health (REACH) Registry enrolled outpatients > or =45 years of age who had established coronary artery, cerebrovascular, or peripheral artery disease or > or =3 atherothrombotic risk factors. Data on risk factors, associated medications, and vascular hospitalizations and interventions were collected. Of the total 68 236-patient REACH cohort, 25 763 were enrolled from US sites. Complete 1-year data were available for 23 974 (93%) of the US patients. Annualized medication costs ranged from $2401 to $3481. Mean annual hospitalization costs per patient were $1344, $2864, $4824, and $8155 for patients with 0 (n=6145), 1 (n=14 353), 2 (n=3106), and 3 (n=370) affected arterial beds at baseline (P<0.0001 for trend). Among patients with 1 affected arterial bed, mean hospitalization costs were $2999, $2010, and $3911 for patients with coronary artery disease (n=11 063), cerebrovascular disease (n=2613), and peripheral arterial disease (n=677), respectively. Annualized medication costs ranged from $2401 to $3481. CONCLUSIONS: These results reveal the high economic burden of atherothrombosis-related clinical events and procedures and the especially high economic burden associated with polyvascular disease.

Patient-reported outcome instrument selection: designing a measurement strategy.

OBJECTIVE: To discuss issues in the design of a measurement strategy related to the use of patient-reported outcomes (PROs) in support of a labelling claim. METHODS: In association with the release by the US Food and Drug Administration of its draft guidance on the use of PROs to support labeling claims, the Mayo/FDA Patient-Reported Outcomes Consensus Writing Group was formed. This paper, part of a series of manuscripts produced by the Writing Group, focuses on designing a PRO measurement strategy. RESULTS: Developing a PRO measurement strategy begins with a clear statement about the proposed label claim that will derive from the PRO data. Investigators should identify the relevant domains to measure, develop a conceptual framework, identify alternative approaches for measuring the domains, and synthesize the information to design the measurement strategy. Often, there is not an already existing single instrument that has been developed and validated for the purposes of a given study. In such cases, investigators may consider supplementing an already existing questionnaire with additional scales or questions, modifying already existing instruments for a new application or patient population, or developing a new instrument altogether. The level of revalidation required for modifications and adaptations depends on the extent of the changes made. Revalidation requirements may range from cognitive testing/debriefing to confirm that subjects respond to the new instrument as expected to full-scale reliability and validity evaluations. CONCLUSION: A position of "reasonable pragmatism" is recommended such that the best available measurement strategy be considered as evidence for labeling.

Assessing health state utilities in elderly patients at cardiovascular risk.

BACKGROUND: Health state preferences can be a crucial component of cost-effectiveness analyses, but off-the-shelf health state utilities specifically for older people are not available. OBJECTIVES: Among participants in PROSPER, a trial of pravastatin in patients>70 years, the authors assessed utilities for the health states that were relevant for the trial's cost-utility analysis. SUBJECTS AND METHODS: The authors cross-sectionally administered the Health Utilities Index, Mark 3 (HUI) to all PROSPER participants to assess each patient's health state at the time of interview; they then used the scale's multiattribute utility function to estimate the resulting utilities. The population was then stratified into 3 health states, and the mean utility function for each was calculated: recent myocardial infarction (MI, within 3 months), previous MI (>3 months), or no prior MI. Linear and logistic regression were used to control for potential demographic and clinical characteristics. RESULTS: Of the 5804 patients enrolled in the trial, 4677 were administered the HUI instrument. The likelihood of having a complete HUI response set decreased with higher age (P<0.001) but not with the other variables studied. A complete utility score could be calculated for 3390 participants. Of these, 2755 (81.3%) had no history of MI, 546 (16.1%) had an MI>3 months previously, and 89 (2.6%) had an MI within 3 months. The mean (median) utilities were virtually identical for these states: 0.75 (0.84), 0.74 (0.84), and 0.74 (0.84), respectively. From multivariate analyses, utilities decreased with higher age and the presence of several other comorbidities (diabetes, stroke, peripheral vascular disease); women had lower utilities than men (all P<0.01). CONCLUSIONS: In this large implementation of the HUI in elderly patients, the instrument did not detect any differences in estimated utilities related to having a MI. Potential causes of nondiscrimination for MI include the possibility that competing comorbidities may reduce the impact of MI on quality of life in this age group, as well as the possibility that a standard instrument derived from and validated in younger populations may not perform as well in elderly people.

Allocating funds for cardiovascular disease prevention in light of the NCEP ATP III guidelines.

BACKGROUND: Controversy persists about the most efficient allocation of healthcare funds for cardiovascular disease prevention. Previous economic analyses have generally focused on primary or secondary prevention as discrete categories. OBJECTIVES: To address the information required by decision-makers to distribute budgets optimally across an entire population at risk in view of recommendations promulgated by the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III). STUDY DESIGN AND METHODS: The Continuum of Risk Evaluation (CORE) model is an individual patient simulation of the occurrence of cardiovascular disease allowing for analyses over a broad range of risk. All events are tallied, costs are applied, and survival is modified accordingly. Disaggregated presentation of the results allows decision-makers to evaluate the budgetary implications and cost effectiveness of different strategies according to the risk at which treatment is initiated. This process is illustrated for the United States using information from the 1988-1994 National Health and Nutrition Examination Survey and pravastatin trials. RESULTS: Secondary prevention with pravastatin costs dollar 2900 per life-year gained for men and dollar 1100 per life-year gained for women. Lowering the treatment threshold to incorporate primary prevention yields cost-effectiveness ratios that remain below dollar 25 000 per undiscounted life-year gained until a 10-year cardiovascular disease risk of 14.4%. Cost savings are possible for very high-risk patients. CONCLUSIONS: The economic impact of an integrated approach to prevention of cardiovascular disease has not been thoroughly explored. CORE permits realistic analysis of policy decisions involving the entire continuum of risk rather than isolated consideration of specific disease stages, and thus provides a unique tool for assessing the full implications of treatment guidelines such as those of the NCEP ATP III.