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Articles by H. M. Krumholz
Total Records ( 7 ) for H. M. Krumholz
  J. S Ross , D Madigan , K. P Hill , D. S Egilman , Y Wang and H. M. Krumholz
 

Background  In September 2004, rofecoxib was voluntarily withdrawn from the worldwide market. Our objective was to determine whether and when analysis of published and unpublished placebo-controlled trials could have revealed cardiovascular risk associated with rofecoxib before its withdrawal as an example to inform future postmarket pharmaceutical safety surveillance efforts.

Methods  We conducted a cumulative subject-level pooled analysis of data from all randomized, placebo-controlled trials of rofecoxib conducted by the manufacturer before September 2004. Our main outcome measurement was incidence of any investigator-reported death from any cause or cardiovascular thromboembolic (CVT) adverse event.

Results  We identified 30 randomized, placebo-controlled trials of rofecoxib that enrolled a combined 20 152 subjects. Trial duration ranged from 4 weeks to 4 years; enrollment ranged from 17 to 2586 subjects prescribed either rofecoxib or placebo; and rofecoxib dose ranged from 12.5 mg to 50 mg. As of December 2000, 21 of these trials had been completed (70%), and the risk of a CVT adverse event or death was greater among subjects assigned to the rofecoxib group (rate ratio [RR], 2.18; 95% confidence interval [CI], 0.93-5.81) (P = .07), raising concerns from a safety standpoint. Subsequently collected data through June 2001 showed that rofecoxib was associated with a 35% increased risk of a CVT adverse event or death (RR, 1.35; 95% CI, 1.00-1.96) (P = .05). Analyzing data available as of April 2002, we found a 39% increased risk (RR, 1.39; 95% CI, 1.07-1.80) (P = .02), and using data available as of September 2004, we found a 43% increased risk (RR,1.43; 95% CI, 1.16-1.76) (P < .001).

Conclusion  Cumulative pooled analysis of all randomized, placebo-controlled trials demonstrates a trend toward increased cardiovascular risk associated with rofecoxib compared with placebo as early as December 2000, the comparison reaching a P value of .05 by June 2001, nearly 31/2 years before the manufacturer's voluntary market withdrawal.

  G. K Mulvey , Y Wang , Z Lin , O. J Wang , J Chen , P. S Keenan , E. E Drye , S. S Rathore , S. L. T Normand and H. M. Krumholz
 

Background— The rankings of "America’s Best Hospitals" by U.S. News & World Report are influential, but the performance of ranked hospitals in caring for patients with routine cardiac conditions such as heart failure is not known.

Methods and Results— Using hierarchical regression models based on medical administrative data from the period July 1, 2005, to June 30, 2006, we calculated risk-standardized mortality rates and risk-standardized readmission rates for ranked and nonranked hospitals in the treatment of heart failure. The mortality analysis examined 14 813 patients in 50 ranked hospitals and 409 806 patients in 4761 nonranked hospitals. The readmission analysis included 16 641 patients in 50 ranked hospitals and 458 473 patients in 4627 nonranked hospitals. Mean 30-day risk-standardized mortality rates were lower in ranked versus nonranked hospitals (10.1% versus 11.2%, P<0.01), whereas mean 30-day risk-standardized readmission rates were no different between ranked and nonranked hospitals (23.6% versus 23.8%, P=0.40). The 30-day risk-standardized mortality rates varied widely for both ranked and nonranked hospitals, ranging from 7.9% to 12.4% for ranked hospitals and from 7.1% to 17.5% for nonranked hospitals. The 30-day risk-standardized readmission rates also spanned a large range, from 18.7% to 29.3% for ranked hospitals and from 19.2% to 29.8% for nonranked hospitals.

Conclusions— Hospitals ranked by U.S. News & World Report as "America’s Best Hospitals" in "Heart & Heart Surgery" are more likely than nonranked hospitals to have a significantly lower than expected 30-day mortality rate, but there was much overlap in performance. For readmission, the rates were similar in ranked and nonranked hospitals.

  D. T Ko , J. S Ross , Y Wang and H. M. Krumholz
 

Background— Cardiac catheterization is substantially underused among higher-risk patients with acute myocardial infarction (AMI) with appropriate indications but overused among patients with inappropriate indications. We sought to determine the importance of anticipated benefit and anticipated harm on the use of cardiac catheterization among older patients with AMI.

Methods and Results— We performed an analysis of Medicare fee-for-service beneficiaries hospitalized with an AMI between 1998 and 2001. Multivariate models were developed to determine relative importance of anticipated benefit (baseline cardiovascular risk), anticipated harm (bleeding risk, comorbidities), and demographic factors (age, sex, race, regional invasive intensity) in predicting cardiac catheterization use within 60 days of AMI admission. Analyses were stratified by American College of Cardiology/American Heart Association class I or II as appropriate, and class III as inappropriate. Determinants of reduced likelihood of cardiac catheterization among 42 241 AMI patients with appropriate indications included (in order of importance) older age (likelihood 2=1309.5), higher bleeding risk score (likelihood 2=471.2), more comorbidities (likelihood 2=276.6), female sex (likelihood 2=162.9), hospitalization in low (likelihood 2=67.9) or intermediate intensity invasive regions (likelihood 2=22.4) (all P<0.001), and baseline cardiovascular risk (likelihood 2=6.4, P=0.01). Among 2398 AMI patients with inappropriate indications, significant determinants of greater procedure likelihood included younger age, male sex, lower bleeding risk score, and fewer comorbidities.

Conclusions— Regardless of the procedure indication, the decision to perform cardiac catheterization in this population appears largely driven by demographic factors and potential harm rather than potential benefit of the procedure.

  S. M Bernheim , J. N Grady , Z Lin , Y Wang , S. V Savage , K. R Bhat , J. S Ross , M. M Desai , A. R Merrill , L. F Han , M. T Rapp , E. E Drye , S. L. T Normand and H. M. Krumholz
  Background—

Patient outcomes provide a critical perspective on quality of care. The Centers for Medicare and Medicaid Services (CMS) is publicly reporting hospital 30-day risk-standardized mortality rates (RSMRs) and risk-standardized readmission rates (RSRRs) for patients hospitalized with acute myocardial infarction (AMI) and heart failure (HF). We provide a national perspective on hospital performance for the 2010 release of these measures.

Methods and Results—

The hospital RSMRs and RSRRs are calculated from Medicare claims data for fee-for-service Medicare beneficiaries, 65 years or older, hospitalized with AMI or HF between July 1, 2006, and June 30, 2009. The rates are calculated using hierarchical logistic modeling to account for patient clustering, and are risk-adjusted for age, sex, and patient comorbidities. The median RSMR for AMI was 16.0% and for HF was 10.8%. Both measures had a wide range of hospital performance with an absolute 5.2% difference between hospitals in the 5th versus 95th percentile for AMI and 5.0% for HF. The median RSRR for AMI was 19.9% and for HF was 24.5% (3.9% range for 5th to 95th percentile for AMI, 6.7% for HF). Distinct regional patterns were evident for both measures and both conditions.

Conclusions—

High RSRRs persist for AMI and HF and clinically meaningful variation exists for RSMRs and RSRRs for both conditions. Our results suggest continued opportunities for improvement in patient outcomes for HF and AMI.

  J. H Lichtman , N. P Lorenze , G D'Onofrio , J. A Spertus , S. T Lindau , T. M Morgan , J Herrin , H Bueno , J. A Mattera , P. M Ridker and H. M. Krumholz
  Background—

Among individuals with ischemic heart disease, young women with an acute myocardial infarction (AMI) represent an extreme phenotype associated with an excess mortality risk. Although women younger than 55 years of age account for less than 5% of hospitalized AMI events, almost 16 000 deaths are reported annually in this group, making heart disease a leading killer of young women. Despite a higher risk of mortality compared with similarly aged men, young women have been the subject of few studies.

Methods and Results—

Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO) is a large, observational study of the presentation, treatment, and outcomes of young women and men with AMI. VIRGO will enroll 2000 women, 18 to 55 years of age, with AMI and a comparison cohort of 1000 men with AMI from more than 100 participating hospitals. The aims of the study are to determine sex differences in the distribution and prognostic importance of biological, demographic, clinical, and psychosocial risk factors; to determine whether there are sex differences in the quality of care received by young AMI patients; and to determine how these factors contribute to sex differences in outcomes (including mortality, hospitalization, and health status). Blood serum and DNA for consenting participants will be stored for future studies.

Conclusions—

VIRGO will seek to identify novel and prognostic factors that contribute to outcomes in this young AMI population. Results from the study will be used to develop clinically useful risk-stratification models for young AMI patients, explain sex differences in outcomes, and identify targets for intervention.

  J. S Ross , J Chen , Z Lin , H Bueno , J. P Curtis , P. S Keenan , S. L. T Normand , G Schreiner , J. A Spertus , M. T Vidan , Y Wang and H. M. Krumholz
 

Background— In July 2009, Medicare began publicly reporting hospitals’ risk-standardized 30-day all-cause readmission rates (RSRRs) among fee-for-service beneficiaries discharged after hospitalization for heart failure from all the US acute care nonfederal hospitals. No recent national trends in RSRRs have been reported, and it is not known whether hospital-specific performance is improving or variation in performance is decreasing.

Methods and Results— We used 2004–2006 Medicare administrative data to identify all fee-for-service beneficiaries admitted to a US acute care hospital for heart failure and discharged alive. We estimated mean annual RSRRs, a National Quality Forum-endorsed metric for quality, using 2-level hierarchical models that accounted for age, sex, and multiple comorbidities; variation in quality was estimated by the SD of the RSRRs. There were 570 996 distinct hospitalizations for heart failure in which the patient was discharged alive in 4728 hospitals in 2004, 544 550 in 4694 hospitals in 2005, and 501 234 in 4674 hospitals in 2006. Unadjusted 30-day all-cause readmission rates were virtually identical over this period: 23.0% in 2004, 23.3% in 2005, and 22.9% in 2006. The mean and SD of RSRRs were also similar: mean (SD) of 23.7% (1.3) in 2004, 23.9% (1.4) in 2005, and 23.8% (1.4) in 2006, suggesting similar hospital variation throughout the study period.

Conclusions— National mean and RSRR distributions among Medicare beneficiaries discharged after hospitalization for heart failure have not changed in recent years, indicating that there was neither improvement in hospital readmission rates nor in hospital variations in rates over this time period.

  K. B Dorsey , M Mauldon , R Magraw , J Valka , S Yu and H. M. Krumholz
 

To describe pediatric clinicians’ adherence to practice recommendations for obesity prevention and treatment, we conducted a cross-sectional analysis of 227 medical records of 3- to 18-year-old patients (seen from September 2003 to April 2004) and a longitudinal analysis of data from 632 overweight and obese patients (followed through March 2006). The cross-sectional analysis showed that early practice adopters (n = 3) more frequently recorded BMI (91% of patients), a diagnosis (89%), and counseling (82%) compared with late adopters (n = 9; 34%, 51%, and 48% of patients, respectively; P < .001). The longitudinal analysis showed that among overweight and obese patients, documentation of BMI dropped from 96% at the first clinic visit to 27% by the fifth visit; documentation of individual risk behaviors fell from ≥72% at the first visit to ≤23% at the fifth visit. Despite initial adoption of screening and assessment practices, clinicians’ attention to weight management diminished over time.

 
 
 
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