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Biomedical subjects

Daniel A Albert

Publications and source records attributed to Daniel A Albert.

12 recordsLinked to original sources
PubMed2006

Medicare coverage of tumor necrosis factor alpha inhibitors as an influence on physicians' prescribing behavior.

BACKGROUND: Rheumatoid arthritis is a chronic debilitating disease that affects 1% of the population. Tumor necrosis factor alpha inhibitors, such as etanercept and infliximab, have revolutionized the treatment of rheumatoid arthritis by averting disability but at great financial expense, generally borne by third-party payors. Prior to implementation of the Medicare Modernization Act, Medicare reimbursed for the infusion drug infliximab but not for the self-injectable drug etanercept. To determine the impact of this differential Medicare drug coverage on physicians' prescribing behavior in clinical practice, we analyzed patterns of prescribing etanercept and infliximab for patients with rheumatoid arthritis who had public insurance compared with those who had private insurance. METHODS: We conducted an observational cohort study of 1663 patients with rheumatoid arthritis newly prescribed etanercept or infliximab after enrollment in the National Databank for Rheumatic Diseases. Univariate and multivariable analyses of patient demographic and disease characteristics were conducted to characterize predictors of the biologic drug prescribed. RESULTS: Treatment groups who received etanercept and infliximab differed in 6 of 8 demographic variables and in 8 of 10 disease variables. However, stratification by type of insurance reduced many of these differences. In multivariable analyses, type of insurance plan and demographic factors were strong predictors of differential prescribing of etanercept compared with prescribing of infliximab, whereas disease characteristics generally were not. Patients with public insurance were 30% more likely to receive infliximab than those who were privately insured (P<.001). CONCLUSIONS: Public insurance predicted prescription of infliximab, reflecting preferential Medicare reimbursement for infusion drugs. Financial considerations are influential in physicians' prescription decisions. Differential drug coverage has an impact on patient care and health care costs because it influences physicians' prescribing behavior.

Age Distribution↗
PubMed2005

Management of aortic disease in Marfan Syndrome: a decision analysis.

BACKGROUND: Marfan syndrome is a relatively common heritable disorder of connective tissue that affects numerous organ systems, but the most severe complication is aortic aneurysm and dissection. A variety of medical and surgical approaches are available for managing the cardiovascular complications. Our objective was to compare elective composite graft surgery, elective valve-sparing surgery, and medical management for patients with both Marfan syndrome and thoracic aortic disease on the basis of life expectancy with differing diameters of the aortic root and rate of increase in the aortic root size. METHODS: A Markov decision analysis model was constructed to compare the 2 surgical options with watchful waiting with medical therapy. RESULTS: For our base-case analysis of a 20-year-old patient with Marfan syndrome and thoracic aortic aneurysm, the aortic valve-sparing option was preferred. It extended life expectancy to 73.8 years compared with the medical treatment option (71.4 years) and with the composite graft surgery (72.7 years). Our results show that there is a better outcome for a patient with an aortic root diameter between 3.0 and 3.5 cm with early prophylactic surgery than with deferred or emergency surgery. Medical treatment was preferred when the aortic root diameter was smaller than 3.0 cm. CONCLUSIONS: Although long-term follow-up data are not yet available, it appears that advances in the technique of valve-sparing surgery have made it the preferred option to composite graft, primarily to avoid the complications of anticoagulation. Our study indicates that patients who have an aortic root diameter of larger than 3.0 cm should be considered for prophylactic aortic surgery.

Adult↗
PubMed2005

Analysis of a cluster of cases of Wegener granulomatosis.

BACKGROUND: Wegener granulomatosis is a chronic inflammatory autoimmune disease of unknown etiology. The sporadic occurrence, lack of familial or genetic associations, and rising incidence suggest possible exposure to environmental agents as causative for this disease. OBJECTIVE: The objective of this study was to examine possible environmental triggers of Wegener granulomatosis. METHODS: While conducting an environmental survey of potential precipitants of Wegener granulomatosis on a cohort of patients seen at Doylestown Hospital and at the University of Pennsylvania, we identified a cluster of cases in the Dublin, Pennsylvania, region. Through hospital records and patient contacts, we located 7 cases diagnosed in a 3-year period within a 10-mile radius of an Environmental Protection Agency (EPA) Superfund toxic waste site. The radius of inclusion represents a population of approximately 50,000 individuals. Assuming complete ascertainment of cases--which is unlikely given the methods used to acquire patients--the prevalence is 2- to 4-fold greater than the expected rate of 3 per 100,000. We identified toxins at or above "action level" within the demarcated geographic region using published data from the EPA. Furthermore, we queried patients regarding their particular chemical exposures. RESULTS: These patients with Wegener granulomatosis were possibly exposed to high levels of trichloroethylene (TCE), vinyl chloride, methyl tertiary-butyl ether (MTBE), dichloroethene (DCE), and chromic acid from several industrial waste sites within the area. Additionally, these patients reported a total of greater than 30 possible exposures, including the aforesaid chemical contaminants. Three of 5 patients whose water source is known had well water that exposed them to industrial runoff and necessitated EPA intervention. CONCLUSION: This data, along with other epidemiologic studies, suggest possible toxic exposures as potentially correctable risk factors for Wegener granulomatosis. We encourage clinicians to seek data that suggests an unusual environmental exposure and to solicit information that might implicate an industrial source for these exposures.

Carcinogens, Environmental↗
PubMed2004

Criteria for improvement in rheumatoid arthritis: alternatives to the American College of Rheumatology 20.

OBJECTIVE: Appropriate outcome measures are critical to estimating treatment effects in clinical trials and observational studies. The American College of Rheumatology 20 (ACR 20) is the standard measure to assess treatment effects in rheumatoid arthritis (RA) randomized controlled clinical trials (RCT). Although the ACR 20, which measures at least a 20% improvement in a number of different measures, is a very useful dichotomous measure for identifying novel treatments with potential activity, it may fail to discriminate among active treatments. In an effort to increase stringency, trials have used the ACR at 50% and 70%. We investigated the behavior of these and other scoring systems to quantify treatment outcome in several RCT in RA. METHODS: The Cooperating Clinics for the Systematic Study of Rheumatic Disease (CSSRD) database contained 2 trials with a total of 6 arms. Using raw data for each patient entered, we calculated ACR 20, 50, and 70 for each arm. We also calculated the average number of criteria met for the ACR 20, 50, and 70 and their respective areas under the curve over time. RESULTS: The ACR 20 failed to discriminate among active therapies; however, the ACR 50 was too stringent, and only one patient in these trials satisfied the ACR 70. The average number of criteria satisfied at the 50% level at the final trial visit discriminated well, as did the area under the curve. CONCLUSION: The average number of ACR criteria met at a 20% or 50% level discriminated better than the traditional ACR criteria in these trials. More of the information is preserved by the area under the curve of the number of ACR criteria satisfied at each level because area preserves both the number of criteria and the time dependence. The area under the curve of the number of ACR criteria met is a discriminatory, specific, time-dependent, responsive, and domain-preserving metric to use as the primary outcome measure in trials of agents for the treatment of RA. These conclusions should be tested in additional data sets.

Antirheumatic Agents↗
PubMed2002

Cost-effectiveness analysis of the Lyme disease vaccine.

OBJECTIVE: A vaccine for Lyme disease was approved in 1998 for use in the US. Given the high cost of the vaccine, the low risk of Lyme disease in many areas, and the largely curable nature of the disease, the cost-effectiveness of the vaccine in various risk groups is uncertain. This study was undertaken to examine the cost-effectiveness of the Lyme disease vaccine and the factors that influence its cost-effectiveness. METHODS: We constructed a Markov decision-analysis model to evaluate the clinical effectiveness and cost-effectiveness of the Lyme disease vaccine in populations at various levels of risk for the disease. The probabilities of clinical events and costs were estimated from reports in the literature. Sensitivity analyses assessed the impact of potential variations of parameters on model results. RESULTS: At the average national incidence of Lyme disease (0.0067%), the incremental cost-effectiveness of vaccination was approximately $1,600,000 per case averted when a yearly booster was given for 10 years after the standard initial vaccination regimen of 3 inoculations at 0, 1, and 12 months. For populations with an annual Lyme disease incidence of 1% (the incidence in several well-defined geographical areas of the US), the incremental cost-effectiveness was approximately $9,900 per case averted. Disease incidence had to exceed 10% before vaccination with yearly boosters became both more effective and more cost saving than no vaccination. CONCLUSION: The Lyme disease vaccine is cost-effective only for individuals who live in areas where Lyme disease is endemic and who are frequently exposed to ticks.

Cost-Benefit Analysis↗
PubMed2002

Methotrexate, hydroxychloroquine, and intramuscular gold in rheumatoid arthritis: relative area under the curve effectiveness and sequence effects.

OBJECTIVE: The use of disease modifying antirheumatic drugs (DMARD) for rheumatoid arthritis (RA) is predicated on the expected value of the treatment course. Most clinical data are generalized from randomized controlled trials (RCT), which may result in estimates that are discordant with clinical experience and cannot address the effects of sequence of drugs. We computed estimates of relative DMARD effectiveness from a large observational database using area under the curve (AUC) data. METHODS: We examined data collected over a 20 year period on 1160 patients who were followed at the Wichita Arthritis Center. We utilized Health Assessment Questionnaire (HAQ) disability index data to quantify the effect of methotrexate (MTX), hydroxychloroquine (HCQ), and injectable gold (gold) on subsequent patient outcome. Using an AUC analysis, we compared length of treatment course, total disability averted, annual disability averted, and percentage of possible disability averted across drugs, and examined differences between first courses of therapy in DMARD naive patients and subsequent courses of the same and different DMARD in patients. RESULTS: Patients treated with MTX, HCQ, and gold improved at a rate of -0.33, -0.18 and -0.38 annualized HAQ area units, respectively. Since duration taking drug was greatest for MTX, then HCQ, then gold, the cumulative improvement was greatest with MTX (-1.07) versus gold (-0.74) versus HCQ (-0.47) in disability unit years. All 3 drugs were better cumulatively with earlier disease (MTX-1.74 for < 1 yr vs -0.95 for > 1 yr; HCQ -0.68 vs -0.43; gold -1.71 vs -0.49). A second trial of the same drug was far less effective than the first course. On a percentage of possible improvement basis, these drugs were nearly equal since HCQ is given to less severely affected patients. CONCLUSION: MTX is the most effective DMARD of these 3 because of the length the therapeutic segment. In terms of disability averted, none of the agents decrease disability by more than 25% of the theoretically possible improvement. We documented that effectiveness of RA treatment is a function of drug sequence, duration of disease, whether it is a first or second course, and severity of disease. None of these clinically relevant observations have emerged from clinical trials. These methodologic approaches provide important quantitative comparative data and will be useful in further assessment of the relative effectiveness of present and future DMARD.

Antirheumatic Agents↗