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Articles by K. A Schulman
Total Records ( 7 ) for K. A Schulman
  L. H Curtis , B. G Hammill , K. A Schulman and S. W. Cousins

Objective  To examine associations between therapies for age-related macular degeneration and risks of all-cause mortality, incident myocardial infarction, bleeding, and incident stroke.

Methods  We conducted a retrospective cohort study of 146 942 Medicare beneficiaries 65 years or older with a claim for age-related macular degeneration between January 1, 2005, and December 31, 2006. On the basis of claims for the initial treatment, we assigned beneficiaries to 1 of 4 groups. The active control group included patients who received photodynamic therapy. The other groups included patients who received intravitreous pegaptanib octasodium, bevacizumab, or ranibizumab. We censored data from patients when they received a therapy different from the initial therapy. The main outcome measures were associations between photodynamic, pegaptanib, bevacizumab, and ranibizumab therapies and the risks of all-cause mortality, incident myocardial infarction, bleeding, and incident stroke.

Results  After adjustment for baseline characteristics and comorbid conditions, we found significant differences in the rates of mortality and myocardial infarction by treatment group. Specifically, the hazard of mortality was significantly lower with ranibizumab therapy than with photodynamic therapy (hazard ratio, 0.85; 99% confidence interval, 0.75-0.95) or pegaptanib use (0.84; 0.74-0.95), and the hazard of myocardial infarction was significantly lower with ranibizumab use than with photodynamic therapy (0.73; 0.58-0.92). There were no significant differences in the hazard of mortality or myocardial infarction between bevacizumab use and the other therapies. We found no statistically significant relationship between treatment group and bleeding events or stroke.

Conclusion  Bevacizumab and ranibizumab use was not associated with increased risks of mortality, myocardial infarction, bleeding, or stroke compared with photodynamic therapy or pegaptanib use.

  B. G Hammill , L. H Curtis , K. A Schulman and D. J. Whellan

Background— For patients with coronary heart disease, exercise-based cardiac rehabilitation improves survival rate and has beneficial effects on risk factors for coronary artery disease. The relationship between the number of sessions attended and long-term outcomes is unknown.

Methods and Results— In a national 5% sample of Medicare beneficiaries, we identified 30 161 elderly patients who attended at least 1 cardiac rehabilitation session between January 1, 2000, and December 31, 2005. We used a Cox proportional hazards model to estimate the relationship between the number of sessions attended and death and myocardial infarction (MI) at 4 years. The cumulative number of sessions was a time-dependent covariate. After adjustment for demographic characteristics, comorbid conditions, and subsequent hospitalization, patients who attended 36 sessions had a 14% lower risk of death (hazard ratio [HR], 0.86; 95% confidence interval [CI], 0.77 to 0.97) and a 12% lower risk of MI (HR, 0.88; 95% CI, 0.83 to 0.93) than those who attended 24 sessions; a 22% lower risk of death (HR, 0.78; 95% CI, 0.71 to 0.87) and a 23% lower risk of MI (HR, 0.77; 95% CI, 0.69 to 0.87) than those who attended 12 sessions; and a 47% lower risk of death (HR, 0.53; 95% CI, 0.48 to 0.59) and a 31% lower risk of MI (HR, 0.69; 95% CI, 0.58 to 0.81) than those who attended 1 session.

Conclusions— Among Medicare beneficiaries, a strong dose–response relationship existed between the number of cardiac rehabilitation sessions and long-term outcomes. Attending all 36 sessions reimbursed by Medicare was associated with lower risks of death and MI at 4 years compared with attending fewer sessions.

  D. J Whellan , M. A Greiner , K. A Schulman and L. H. Curtis

Background— Inpatient care is the primary driver of costs for patients with heart failure. It is unclear whether recent advances in heart failure care have reduced the costs to Medicare for the care of inpatients with heart failure.

Methods and Results— In a retrospective cohort study of 1 363 977 elderly Medicare beneficiaries hospitalized with heart failure between January 1, 2001, and December 31, 2004, we examined costs to Medicare for all inpatient care, inpatient cardiovascular care, and inpatient heart failure care and the adjusted relationships between patient characteristics and costs. Among 1 363 977 Medicare beneficiaries with an index heart failure hospitalization, 901 885 (66%) had a subsequent inpatient claim during the following year. Noncardiovascular costs accounted for 57% of total inpatient costs, and costs associated with heart failure hospitalizations accounted for 15% of total inpatient costs. No significant changes occurred in total, cardiovascular, and heart failure inpatient costs over time.

Conclusions— The costs of inpatient care for patients with heart failure are high, but most subsequent inpatient costs are attributable to noncardiovascular and non–heart failure admissions. Further research is needed to identify predictors of costs, so that patients can be stratified according to risk, and to evaluate strategies that target primary cost drivers for patients with heart failure.

  A. K Fortune Greeley , N. C Hardy , L Lin , J. Y Friedman , J. S Lawlor , L. H Muhlbaier , M. A Hall , K. A Schulman , J Sugarman and K. P. Weinfurt

Background— Although the informed consent process is supposed to help potential research participants make informed and voluntary decisions about participating in research, little is known about how participants react to language in the informed consent document and whether their reactions are related to their willingness to enroll in clinical trials. We examined the relationship between patients’ reactions to standard informed consent language and their willingness to participate in a hypothetical clinical trial.

Methods and Results— We simulated the consent process for a hypothetical cardiology clinical trial with 470 patients in an outpatient cardiovascular medicine clinic at a large academic medical center. We analyzed the spontaneous comments and questions that participants made during the interviews about each section of the informed consent document. Few participants made positive comments. Participants made the most negative comments about the sections on risks, study purpose or protocol, and payment for injury. Having a negative reaction to any section was associated with a lower likelihood of participating in the clinical trial. Using a multivariable model, we found that negative reactions in the patient rights, financial disclosure, and confidentiality sections predicted willingness to participate (P<0.001).

Conclusions— Recognizing elements of informed consent that elicit questions and concerns from potential research participants may help investigators design clinical research trials and model language in a way that reduces concerns or increases participant understanding, thereby enhancing informed consent for research.

  S. D Reed , D. J Whellan , Y Li , J. Y Friedman , S. J Ellis , I. L Pina , S. J Settles , L Davidson Ray , J. L Johnson , L. S Cooper , C. M O'Connor , K. A Schulman and for the HF ACTION Investigators

Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) assigned 2331 outpatients with medically stable heart failure to exercise training or usual care. We compared medical resource use and costs incurred by these patients during follow-up.

Methods and Results—

Extensive data on medical resource use and hospital bills were collected throughout the trial for estimates of direct medical costs. Intervention costs were estimated using patient-level trial data, administrative records, and published unit costs. Mean follow-up was 2.5 years. There were 2297 hospitalizations in the exercise group and 2332 in the usual care group (P=0.92). The mean number of inpatient days was 13.6 (standard deviation [SD], 27.0) in the exercise group and 15.0 (SD, 31.4) in the usual care group (P=0.23). Other measures of resource use were similar between groups, except for trends indicating that fewer patients in the exercise group underwent high-cost inpatient procedures. Total direct medical costs per participant were an estimated $50 857 (SD, $81 488) in the exercise group and $56 177 (SD, $92 749) in the usual care group (95% confidence interval for the difference, $–12 755 to $1547; P=0.10). The direct cost of exercise training was an estimated $1006 (SD, $337). Patient time costs were an estimated $5018 (SD, $4600).


The cost of exercise training was relatively low for the health care system, but patients incurred significant time costs. In this economic evaluation, there was little systematic benefit in terms of overall medical resource use with this intervention.

Clinical Trial Registration—

URL: Unique identifier: NCT00047437.

  L. H Curtis , M. A Greiner , M. R Patel , P. W Duncan , K. A Schulman and D. B. Matchar

Diagnostic imaging among Medicare beneficiaries is an important contributor to rising health care costs. We examined temporal trends and geographic variation in the use of carotid ultrasound, carotid magnetic resonance angiography (MRA), and carotid x-ray angiography.

Methods and Results—

Analysis of a 5% national sample of claims from the Centers for Medicare and Medicaid Services for 1999 through 2006. Patients were 65 years or older and underwent carotid ultrasound, carotid MRA, carotid x-ray angiography, or a carotid intervention. The main outcome measures were annual age-adjusted rates of carotid imaging and interventions and factors associated with the use of carotid imaging. Rates of imaging increased by 27%, from 98.2 per 1000 person-years in 2001 to 124.3 per 1000 in 2006. Rates of carotid ultrasound increased by 23%, and rates of MRA increased by 66%. Carotid intervention rates decreased from 3.6 per 1000 person-years in 2001 to 3.1 per 1000 person-years in 2006. In 2006, rates of carotid ultrasound were lowest in the New England, Mountain, and West North Central regions and highest in the Middle Atlantic and South Atlantic regions. Regional differences persisted after adjustment for patient demographic characteristics, history of vascular disease and other comorbid conditions, and study year.


From 2001 through 2006, there was substantial growth and variation in the use of carotid imaging, including a marked increase in the use of MRA, and a decrease in the overall rate of carotid intervention.

  A. F Hernandez , G. C Fonarow , B. G Hammill , S. M Al Khatib , C. W Yancy , C. M O'Connor , K. A Schulman , E. D Peterson and L. H. Curtis

Background— The clinical effectiveness of implantable cardioverter-defibrillators (ICDs) in older patients with heart failure has not been established, and older patients have been underrepresented in previous studies.

Methods and Results— We identified patients with heart failure who were aged 65 years or older and were eligible for an ICD, had left ventricular ejection fraction of 35% or less, and were discharged alive from hospitals participating in the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients With Heart Failure and the Get With the Guidelines–Heart Failure quality-improvement programs during the period January 1, 2003, through December 31, 2006. We matched the patients to Medicare claims to examine long-term outcomes. The main outcome measure was all-cause mortality over 3 years. The study population included 4685 patients who were discharged alive and were eligible for an ICD. Mean age was 75.2 years, 60% of the patients were women, mean ejection fraction was 25%, and 376 (8.0%) patients received an ICD before discharge. Mortality was significantly lower among patients who received an ICD compared with those who did not (19.8% versus 27.6% at 1 year, 30.9% versus 41.9% at 2 years, and 38.1% versus 52.3% at 3 years; P<0.001 for all comparisons). The inverse probability-weighted adjusted hazard of mortality at 3 years for patients receiving an ICD was 0.71 (95% CI, 0.56 to 0.91).

Conclusions— Medicare beneficiaries hospitalized with heart failure and left ventricular ejection fraction of 35% or less who were selected for ICD therapy had lower risk-adjusted long-term mortality compared with those who did not receive an ICD.

Clinical Trial Registration— Identifier: NCT00344513.

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