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Biomedical subjects

Kevin A Schulman

Publications and source records attributed to Kevin A Schulman.

At least 19 recordsLinked to original sources
PubMed2007

Cost of cancer care: issues and implications.

Medical technology is increasingly costly in most fields of clinical medicine. Oncology has not been spared from issues related to cost, in part resulting from the tremendous scientific progress that has lead to new tools for diagnosis, treatment, and follow-up of our patients. The increasing cost of health care in general (and cancer care in particular) raises complex questions related to its effects on our economy and the citizens of our society. This article reviews the macroeconomic principles and individual behaviors that govern medical spending, and examines how cost disproportionately affects various populations. Our overall goal is to frame debate about health policy concerns that influence the clinical practice of oncology.

Biomedical Technology↗
PubMed2007

Relationship between body mass index and prostate cancer screening in the United States.

PURPOSE: Obesity is associated with more advanced disease and worse outcomes in men with prostate cancer. To our knowledge the relationship between obesity and prostate cancer screening behavior in men 40 or older is unknown. Thus, we examined associations between body mass index and prostate cancer screening behavior. MATERIALS AND METHODS: We used the 2002 Behavioral Risk Factor Surveillance System to study prostate cancer screening in a representative sample of 57,827 men 40 years or older. Primary outcomes were the proportion of men ever screened and the proportion screened in the last year for prostate cancer. RESULTS: Obese men were more likely than normal weight men to have had a prostate specific antigen test (62.1% vs 56.1%, p <0.001) and to have had a prostate specific antigen test in the last year (44.2% vs 38.2%, p <0.001). After controlling for sociodemographic characteristics obese men remained more likely than normal weight men to have had a prostate specific antigen test (OR 1.46, 95% CI 1.33-1.61) and to have had a prostate specific antigen test in the last year (OR 1.42, 95% CI 1.30-1.55). Respondents reporting an ongoing relationship with a physician (OR 2.88, 95% CI 2.57-3.22) and black nonHispanic men vs white men (OR 1.58, 95% CI 1.38-1.81) were also more likely to have had a prostate specific antigen test in the last year. CONCLUSIONS: Obese men are more likely than normal weight men to be screened for prostate cancer. Associations between advanced stage, worse outcomes and obesity may not be explained by disparities in the screening of obese men for prostate cancer.

Adult↗
PubMed2006

Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation.

CONTEXT: Recent studies of drug-eluting intracoronary stents suggest that current antiplatelet regimens may not be sufficient to prevent late stent thrombosis. OBJECTIVE: To assess the association between clopidogrel use and long-term clinical outcomes of patients receiving drug-eluting stents (DES) and bare-metal stents (BMS) for treatment of coronary artery disease. DESIGN, SETTING, AND PATIENTS: An observational study examining consecutive patients receiving intracoronary stents at Duke Heart Center, a tertiary care medical center in Durham, NC, between January 1, 2000, and July 31, 2005, with follow-up contact at 6, 12, and 24 months through September 7, 2006. Study population included 4666 patients undergoing initial percutaneous coronary intervention with BMS (n = 3165) or DES (n = 1501). Landmark analyses were performed among patients who were event-free (no death, myocardial infarction [MI], or revascularization) at 6- and 12-month follow-up. At these points, patients were divided into 4 groups based on stent type and self-reported clopidogrel use: DES with clopidogrel, DES without clopidogrel, BMS with clopidogrel, and BMS without clopidogrel. MAIN OUTCOME MEASURES: Death, nonfatal MI, and the composite of death or MI at 24-month follow-up. RESULTS: Among patients with DES who were event-free at 6 months (637 with and 579 without clopidogrel), clopidogrel use was a significant predictor of lower adjusted rates of death (2.0% with vs 5.3% without; difference, -3.3%; 95% CI, -6.3% to -0.3%; P = .03) and death or MI (3.1% vs 7.2%; difference, -4.1%; 95% CI, -7.6% to -0.6%; P = .02) at 24 months. However, among patients with BMS (417 with and 1976 without clopidogrel), there were no differences in death (3.7% vs 4.5%; difference, -0.7%; 95% CI, -2.9% to 1.4%; P = .50) and death or MI (5.5% vs 6.0%; difference, -0.5%; 95% CI, -3.2% to 2.2%; P = .70). Among patients with DES who were event-free at 12 months (252 with and 276 without clopidogrel), clopidogrel use continued to predict lower rates of death (0% vs 3.5%; difference, -3.5%; 95% CI, -5.9% to -1.1%; P = .004) and death or MI (0% vs 4.5%; difference, -4.5%; 95% CI, -7.1% to -1.9%; P<.001) at 24 months. However, among patients with BMS (346 with and 1644 without clopidogrel), there continued to be no differences in death (3.3% vs 2.7%; difference, 0.6%; 95% CI, -1.5% to 2.8%; P = .57) and death or MI (4.7% vs 3.6%; difference, 1.0%; 95% CI, -1.6% to 3.6%; P = .44). CONCLUSIONS: The extended use of clopidogrel in patients with DES may be associated with a reduced risk for death and death or MI. However, the appropriate duration for clopidogrel administration can only be determined within the context of a large-scale randomized clinical trial.

Aged↗
PubMed2006

Financial implications of a model heart failure disease management program for providers, hospital, healthcare systems, and payer perspectives.

Although heart failure disease management (HFDM) programs improve patient outcomes, the implementation of these programs has been limited because of financial barriers. We undertook the present study to understand the economic incentives and disincentives for adoption of disease management strategies from the perspectives of a physician (group), a hospital, an integrated health system, and a third-party payer. Using the combined results of a group of randomized controlled trials and a set of financial assumptions from a single academic medical center, a financial model was developed to compute the expected costs before and after the implementation of a HFDM program by 3 provider types (physicians, hospitals, and health systems), as well as the costs incurred from a payer perspective. The base-case model showed that implementation of HFDM results in a net financial loss to all potential providers of HFDM. Implementation of HFDM as described in our base-case analysis would create a net loss of US dollars 179,549 in the first year for a physician practice, US dollars 464,132 for an integrated health system, and US dollars 652,643 in the first year for a hospital. Third-party payers would be able to save US dollars 713,661 annually for the care of 350 patients with heart failure in a HFDM program. In conclusion, although HFDM programs may provide patients with improved clinical outcomes and decreased hospitalizations that save third-party payers money, limited financial incentives are currently in place for healthcare providers and hospitals to initiate these programs.

Cost Savings↗
PubMed2006

Costs for heart failure with normal vs reduced ejection fraction.

BACKGROUND: Among the elderly population, heart failure (HF) with normal ejection fraction (EF) is more common than classic HF with low EF. However, there are few data regarding the costs of HF with normal EF. In a prospective, population-based cohort of elderly participants, we compared the costs and resource use of patients with HF and normal and reduced EF. METHODS: A total of 4549 participants (84.5% white; 40.6% male) in the National Heart, Lung, and Blood Institute Cardiovascular Health Study were linked to Medicare claims from 1992 through 1998. By protocol echo examinations or clinical EF assessments, 881 participants with HF were characterized as having abnormal or normal EF. We applied semiparametric estimators to calculate mean costs per subject for a 5-year period. RESULTS: There were 495 HF participants with normal EF (186 prevalent at study entry and 309 incident during the study period) and 386 participants with abnormal EF (166 prevalent and 220 incident). Participants with abnormal EF had more cardiology encounters and cardiac procedures. However, compared with abnormal EF participants, the 5-year costs for normal EF participants were similar in both the prevalent ($33,023 with abnormal EF and $32,580 with normal EF; P=.93) and incident ($49,128 with abnormal EF and $45,604 with normal EF; P=.55) groups. In models accounting for comorbid conditions, the costs with normal and abnormal EF remained similar. CONCLUSIONS: Over a 5-year period, patients with HF and normal EF consume as many health care resources as those with reduced EF. These data highlight the substantial financial burden of HF with normal EF among the elderly population.

Aged↗
PubMed2006

The cost of acute myocardial infarction in the new millennium: evidence from a multinational registry.

BACKGROUND: Although geographic variation in the treatment of acute myocardial infarction (AMI) has been recognized, the impact of evidence-based international treatment guidelines on such variation is unclear. We sought to characterize resource use and cost of initial hospitalization for AMI in 9 countries and compare the contribution of length of stay (LOS) and procedure use to cost. METHODS: We applied country-specific cost estimates to data from the international AMI registry associated with the VALIANT trial. The registry includes demographic, medical history, treatment, and discharge information for 5573 patients with AMI admitted to 84 sites in 9 countries from November 1999 to June 2001. Hospitalization cost was estimated by imputed discharge diagnosis-related group code and adjusted for the LOS and procedures. Generalized linear regression was used to adjust cost by country; the contribution of LOS and procedures to cost was assessed by ordinary least squares regression. RESULTS: Unadjusted mean cost for initial AMI hospitalization was 9993 dollars (95% CI 9702 dollars-10,228 dollars). After adjustment for baseline patient-level variation, the lowest average cost was 1605 dollars (Argentina) and the highest was 9196 dollars (United States). Length of stay explained more of the variation in cost (50.7%) than did procedure intensity (31.9%). CONCLUSIONS: International differences in the cost of AMI persist, reflecting variations in procedure use and especially LOS. Relative differences in resource costs and incentives inherent in the provision and financing of health care likely contribute to treatment and cost variation and limit the widespread adoption of international practice guidelines.

Aged↗
PubMed2006

Geographic variation in the treatment of acute myocardial infarction in the VALsartan In Acute myocardial iNfarcTion (VALIANT) trial.

BACKGROUND: The VALIANT trial compared the efficacy and safety of captopril, valsartan, and their combination in patients with left ventricular systolic dysfunction, heart failure, or both after acute myocardial infarction (MI). By examining this international trial population of high-risk patients, we sought to determine geographic variations in the use of 3 key treatments for MI. METHODS: We analyzed data from 14,512 high-risk patients with MI in the VALIANT trial from the 20 countries that had enrolled >100 patients. International variation in the proportion of patients receiving (1) reperfusion therapy (thrombolysis or primary percutaneous coronary intervention), (2) beta-blockers, or (3) aspirin at the time of MI was measured by using adjusted W scores. These scores correspond to the number of additional or fewer patients who received each of the therapies compared with the number expected, as estimated from multivariable regression models that account for patients' baseline characteristics. RESULTS: There was marked variation between countries in the use of reperfusion therapy (equivalent to a difference of up to 36/100 potentially eligible patients) and beta-blockers (41/100), whereas there was much less variation in the use of aspirin (13/100). CONCLUSIONS: Marked geographic variation persists in the use of standard evidence-based therapy advocated by international guidelines. Our findings have implications not only for care of patients but also for the conduct of international trials.

Aged↗
PubMed2006

Prostate specific antigen testing in men older than 75 years in the United States.

PURPOSE: Although there is general agreement that men older than 75 years are unlikely to benefit from prostate specific antigen testing, patient reported testing rates in these patients exceed 30%. We examined physician reported PSA testing in elderly men, and physician and practice characteristics associated with testing. MATERIALS AND METHODS: Using the 1999 to 2002 National Ambulatory Medical Care Survey, a nationally representative sample of outpatient visits to nonfederal office based physicians, we measured rates of prostate specific antigen testing by age group in men without prostate cancer who were 40 years or older and who visited outpatient family medicine, internal medicine or urology clinics. RESULTS: An estimated 42.3 million prostate specific antigen tests were performed from 1999 to 2002, of which 5.91 million (14.0%) were performed in men older than 75 years. The population based testing rate was 6.1% in patients 40 to 49-year-old, 26.0% in patients 50 to 75-year-old and 27.8% in patients older than 75 years. Urologists performed 35.4% of prostate specific antigen tests in men older than 75 years. Controlling for sociodemographic variables physicians with a laboratory on site were more likely to perform a prostate specific antigen test (OR 1.35, 95% CI 1.07 to 1.71). In men older than 75 years the odds of prostate specific antigen testing were 1.58 times higher (95% CI 1.01 to 2.50) in practices with a laboratory on site. CONCLUSIONS: Up to a third of men older than 75 years undergo prostate specific antigen testing despite an average life expectancy of less than 10 years. Physician and practice characteristics are associated with prostate specific antigen PSA testing.

Adult↗
PubMed2006

Geographic variations in the use of medical and surgical therapies for benign prostatic hyperplasia.

PURPOSE: Patients with BPH have several treatment options. Little is known about geographic variations in surgical rates for BPH and the market relationships to medical therapy, health resources and sociodemographic factors. MATERIALS AND METHODS: We conducted a cross-sectional study using administrative data from 5 states in 2000. Rates of surgical and medical therapy were calculated per 100,000 men 55 years old or older. Main outcome measures were county level weighted coefficient of variation and systematic component of variation in therapy rates, as well as surgery rates as a function of medication dispensing rates, health care resources and sociodemographic characteristics. RESULTS: North Carolina had the lowest surgery rates (26.3 minimally invasive procedures and 332.1 invasive surgeries per 100,000) and finasteride dispensing rates (503.5 per 100,000). Overall rates of medical therapy were 5 times higher than surgery rates. Geographic variations in surgical and medical therapy rates were significant for each state, and North Carolina had the greatest variation. An increase of 11.6 per 100,000 (95% CI, 6.5-55.8) in annual county level finasteride dispensing would be associated with a decrease in the surgery rate of 1 per 100,000, controlling for other variables. CONCLUSIONS: There is significant systematic variation in rates of surgical and medical therapy for BPH at county and state levels. The relationship between finasteride and surgery in randomized clinical trials is generalizable to the marketplace. Finasteride rates are inversely related to surgery rates, and tamsulosin rates are positively associated with surgery rates. Surgery rates are not significantly associated with urologists per capita.

Adrenergic alpha-Antagonists↗
PubMed2006

Policies of academic medical centers for disclosing financial conflicts of interest to potential research participants.

PURPOSE: To document the current state of institutional review board (IRB) and conflict of interest committee policies regarding disclosures of financial conflicts of interest to potential research participants, and to use this information to identify and share models for effectively achieving disclosure. METHOD: The authors identified the 123 U.S. academic medical centers that have IRBs and sought their IRB and institutional policies regarding financial conflicts of interest. In February and March 2004, using manual and key word searches, each institution's Web site was searched to identify documents containing information regarding the disclosure of financial conflicts of interest. Letters were sent to 24 institutions that had either no information or incomplete information posted on their Web sites. To assess institutions' guidelines for disclosure, the authors extracted and content coded each institution's information on disclosure. RESULTS: Relevant information was obtained from 120 (98%) academic medical centers (AMCs), of which 57 (48%) mentioned disclosing financial conflicts to potential research participants. Of these 57, 33 (58%) included verbatim language that could be used in informed consent documents. AMCs' recommendations and requirements for disclosure included details of the financial arrangement, administrative management of conflicts of interest, and encouragement of dialogue between the investigator and the potential research participant. CONCLUSIONS: Considerable variability exists concerning the specific information that should be disclosed. Most of the AMCs' policies were consistent with the goal of protection from legal liability. Significant questions remain, however, concerning the goals of disclosure and the most effective methods for achieving those goals.

Academic Medical Centers↗
PubMed2006

Geographic variation in the prescription of schedule II opioid analgesics among outpatients in the United States.

OBJECTIVE: To measure geographic variation in opioid use in a large, commercially insured, outpatient population in the United States. DATA SOURCES: Outpatient prescription drug claims database of a national pharmaceutical benefit manager for 7,873,337 subjects with at least one prescription drug claim in 2000. STUDY DESIGN: We measured the period prevalence of claims for opioid analgesics and controlled-release oxycodone at the state level. We measured geographic variation using the weighted coefficient of variation and systematic component of variation. In county-level multivariable regression, we explored associations between potential explanatory variables and claims for opioid analgesics and controlled-release oxycodone. PRINCIPAL FINDINGS: A total of 567,778 (64.2 per 1,000 total claims) were for oral opioid analgesics. Claim rates by state ranged from <20 to >100 claims per 1,000 total claims. States with long-standing prescription monitoring programs had among the lowest rates. In the county-level data, presence of a statewide prescription monitoring program and proportions of the population aged 15-24 and 65 years and older were independently and negatively associated with claim rates for all opioid analgesics. Surgeons per 1,000, proportion of the population reporting illicit drug use, and proportion who were female were independently and positively associated with claim rates for all opioid analgesics. Only the proportion of the population aged 25-34 and number of surgeons per 1,000 were independently and positively associated with claim rates for oxycodone. CONCLUSIONS: Claim rates for opioid analgesics vary significantly by state. Presence of a statewide prescription monitoring program is associated with lower claim rates at the county level. Future research should use individual-level data to assess whether these findings reflect a reduction in abuse and diversion or suboptimal treatment of pain.

Adolescent↗
PubMed2006

Economic evaluation of weekly epoetin alfa versus biweekly darbepoetin alfa for chemotherapy-induced anaemia: evidence from a 16-week randomised trial.

INTRODUCTION: A 16-week, open-label, multicentre, randomised trial of weekly epoetin alfa 40 000 units versus biweekly darbepoetin alfa 200microg among 358 patients with solid-tumour cancers and chemotherapy-induced anaemia demonstrated superior haematological outcomes with epoetin alfa. We sought to compare resource use, costs and clinical outcomes between treatment groups and report the results using a cost-consequences framework. METHODS: Pre-specified methods were used to assign costs (US dollars, year 2004-5 values) to medical resources and patient time using a societal perspective. Costs for inpatient care, outpatient care and physician services were based on US Medicare reimbursement rates. Indirect costs assigned to patient time spent receiving study medication were based on the mean hourly wage in the US. In the base-case analysis, the average wholesale price was used to assign costs to medications. Clinical outcomes included all haemoglobin levels and transfusions recorded throughout the trial. Sensitivity analyses were performed to evaluate the impact of different costing methods, cost sources, perspectives and methods to assign haemoglobin values following a blood transfusion. RESULTS: Over a mean follow-up duration of 11.8 weeks, the average cost of study medications and their administration was the single largest component of total costs and was similar between groups (epoetin alfa 5979 US dollars and darbepoetin alfa 5935 US dollars, difference 44 US dollars; 95% CI -590, 692). There were no significant differences in the proportions of patients hospitalised (epoetin alfa 24.6%, darbepoetin alfa 22.0%; p = 0.57). Patients randomised to epoetin alfa experienced more inpatient days, on average, than patients randomised to darbepoetin alfa (2.6 vs 1.6, 95% CI for the difference, 0.07, 2.27). However, with regard to transfusions, patients in the epoetin alfa arm required fewer units of blood than patients in the darbepoetin alfa arm (0.46 vs 0.88, 95% CI for the difference -0.77, -0.08). Mean total costs, comprising costs for study medications and their administration, inpatient care, transfusions, unplanned radiation therapy, haematology and laboratory services, chemotherapy and non-chemotherapy drugs and indirect costs were 14,976 US dollars in the epoetin alfa arm compared with 14,101 US dollars in the darbepoetin alfa arm, a difference of 875 US dollars (95% CI for difference -849, 2607), of which 98% of the difference was attributable to higher inpatient costs in the epoetin alfa arm (2374 US dollars vs 1520 US dollars; 95% CI for difference -33, 1955). Assessments of multiple clinical measures demonstrated improved outcomes with epoetin alfa relative to darbepoetin alfa. CONCLUSION: Most clinical outcome measures suggested greater improvement with epoetin alfa relative to darbepoetin alfa, but most costs for both agents appeared similar. Decision makers must evaluate the differences in costs and efficacy measures that are most relevant from their perspectives.

Adolescent↗
PubMed2006

Racial differences in health concern.

An understanding of racial differences in risk-related affect may help explain racial differences in health behaviors and outcomes and provide additional opportunities for intervention. In phone interviews with a random community sample of 197 whites, 155 blacks and 163 Latinos, we assessed concern that respondents' health would be hurt by their diet, an inability to exercise, an inability to follow a doctor's recommendations and disease. A multivariate analysis of variance with follow-up profile analysis revealed that whites were less concerned than blacks and Latinos about an inability to follow their doctors' recommendations (ps < 0.01). There were no racial differences in the other health concern variables. Interventions to inform blacks and Latinos about their health risks must strike a balance between creating enough health concern to encourage health behavior but not so much that it interferes with health-promoting behaviors.

Adolescent↗
PubMed2005

Implications of pharmacogenomics for drug development and clinical practice.

Pharmacogenomics is likely to be among the first clinical applications of the Human Genome Project and is certain to have an enormous impact on the clinical practice of medicine. Herein, we discuss the potential implications of pharmacogenomics on the drug development process, including drug safety, productivity, market segmentation, market expansion, differentiation, and personalized health care. We also review 3 challenges facing the translation of pharmacogenomics into clinical practice: dependence on information technology, limited health care financing, and the scientific uncertainty surrounding validation of specific applications of the technology. To our knowledge, there is currently no formal agenda to promote and cultivate innovation, to develop progressive information technology, or to obtain the financing that would be required to advance the use of pharmacogenomic technologies in patient care. Although the potential of these technologies is driving change in the development of clinical sciences, it remains to be seen which health care systems level needs will be addressed.

Animals↗
PubMed2005

Evidence-based therapies and mortality in patients hospitalized in December with acute myocardial infarction.

BACKGROUND: Previous studies suggest that patients hospitalized with acute myocardial infarction (MI) in December have poor outcomes, and some studies have hypothesized that the cause may be the infrequent use of evidence-based therapies during the December holiday season. OBJECTIVE: To compare the care and outcomes of patients with acute MI hospitalized in December and patients hospitalized during other months. DESIGN: Retrospective analysis of data from the Cooperative Cardiovascular Project. SETTING: Nonfederal, acute care hospitals in the United States. PATIENTS: 127 959 Medicare beneficiaries hospitalized between January 1994 and February 1996 with confirmed acute MI. MEASUREMENTS: Use of aspirin, beta-blockers, and reperfusion therapy (thrombolytic therapy or percutaneous coronary intervention), and 30-day mortality. RESULTS: When the authors controlled for patient, hospital, and physician characteristics, the use of evidence-based therapies was not significantly lower but 30-day mortality was higher (21.7% vs. 20.1%; adjusted odds ratio, 1.07 [95% CI, 1.02 to 1.12]) among patients hospitalized in December. LIMITATIONS: This was a nonrandomized, observational study. Unmeasured characteristics may have contributed to outcome differences. CONCLUSIONS: Thirty-day mortality rates were higher for Medicare patients hospitalized with acute MI in December than in other months, although the use of evidence-based therapies was not significantly lower.

Adrenergic beta-Antagonists↗
PubMed2005

Variations in coronary procedure utilization depending on body mass index.

BACKGROUND: Increased body mass index (BMI) (calculated as weight in kilograms divided by the square of height in meters) is a risk factor for coronary heart disease and is associated with lower preventive services utilization. The relationship between BMI and utilization of diagnostic or therapeutic procedures for coronary heart disease has not been examined. METHODS: We evaluated 109 664 Medicare patients who were hospitalized for acute myocardial infarction in a nongovernmental acute care hospital between 1994 and 1996, were 65 years or older, and weighed 159 kg or less. We used logistic regression to examine the relationship of BMI with utilization of cardiac catheterization, percutaneous coronary intervention, and coronary artery bypass grafting while adjusting for patient and hospital characteristics. RESULTS: Participants had a mean age of 75.8 years; 53% were men and 90% were white. Individuals with a BMI of 25.0 to 35.0 had the highest rates of coronary procedure utilization. Compared with patients with a BMI of 25.0 to 29.9, those with a BMI of 35.0 to 39.9 had a reduced adjusted odds ratio (OR) of receiving coronary artery bypass grafting (OR, 0.88; 95% confidence interval [CI], 0.79-0.98), whereas patients with a BMI of 40.0 or greater had the lowest odds of receiving cardiac catheterization (OR, 0.82; 95% CI, 0.73-0.92), percutaneous coronary intervention (OR, 0.89; 95% CI, 0.77-1.03), and coronary artery bypass grafting (OR, 0.68; 95% CI, 0.57-0.82). Patients who did not receive coronary revascularization had higher mortality rates than those who did. CONCLUSIONS: For patients hospitalized with acute myocardial infarction, those with a very high BMI were less likely to receive invasive coronary procedures. Future research should investigate reasons for these variations in coronary procedure utilization.

Aged↗