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1.  National Trends in Patient Safety for Four Common Conditions, 2005–2011 
The New England journal of medicine  2014;370(4):341-351.
Background
Changes in adverse-event rates among Medicare patients with common medical conditions and conditions requiring surgery remain largely unknown.
Methods
We used Medicare Patient Safety Monitoring System data abstracted from medical records on 21 adverse events in patients hospitalized in the United States between 2005 and 2011 for acute myocardial infarction, congestive heart failure, pneumonia, or conditions requiring surgery. We estimated trends in the rate of occurrence of adverse events for which patients were at risk, the proportion of patients with one or more adverse events, and the number of adverse events per 1000 hospitalizations.
Results
The study included 61,523 patients hospitalized for acute myocardial infarction (19%), congestive heart failure (25%), pneumonia (30%), and conditions requiring surgery (27%). From 2005 through 2011, among patients with acute myocardial infarction, the rate of occurrence of adverse events declined from 5.0% to 3.7% (difference, 1.3 percentage points; 95% confidence interval [CI], 0.7 to 1.9), the proportion of patients with one or more adverse events declined from 26.0% to 19.4% (difference, 6.6 percentage points; 95% CI, 3.3 to 10.2), and the number of adverse events per 1000 hospitalizations declined from 401.9 to 262.2 (difference, 139.7; 95% CI, 90.6 to 189.0). Among patients with congestive heart failure, the rate of occurrence of adverse events declined from 3.7% to 2.7% (difference, 1.0 percentage points; 95% CI, 0.5 to 1.4), the proportion of patients with one or more adverse events declined from 17.5% to 14.2% (difference, 3.3 percentage points; 95% CI, 1.0 to 5.5), and the number of adverse events per 1000 hospitalizations declined from 235.2 to 166.9 (difference, 68.3; 95% CI, 39.9 to 96.7). Patients with pneumonia and those with conditions requiring surgery had no significant declines in adverse-event rates.
Conclusions
From 2005 through 2011, adverse-event rates declined substantially among patients hospitalized for acute myocardial infarction or congestive heart failure but not among those hospitalized for pneumonia or conditions requiring surgery. (Funded by the Agency for Healthcare Research and Quality and others.)
doi:10.1056/NEJMsa1300991
PMCID: PMC4042316  PMID: 24450892
2.  Long-Term Outcomes in Elderly Survivors of In-Hospital Cardiac Arrest 
The New England journal of medicine  2013;368(11):1019-1026.
BACKGROUND
Little is known about the long-term outcomes in elderly survivors of in-hospital cardiac arrest. We determined rates of long-term survival and readmission among survivors of in-hospital cardiac arrest and examined whether these outcomes differed according to demographic characteristics and neurologic status at discharge.
METHODS
We linked data from a national registry of inpatient cardiac arrests with Medicare files and identified 6972 adults, 65 years of age or older, who were discharged from the hospital after surviving an in-hospital cardiac arrest between 2000 and 2008. Predictors of 1-year survival and of readmission to the hospital were examined.
RESULTS
One year after hospital discharge, 58.5% of the patients were alive, and 34.4% had not been readmitted to the hospital. The risk-adjusted rate of 1-year survival was lower among older patients than among younger patients (63.7%, 58.6%, and 49.7% among patients 65 to 74, 75 to 84, and ≥85 years of age, respectively; P<0.001), among men than among women (58.6% vs. 60.9%, P = 0.03), and among black patients than among white patients (52.5% vs. 60.4%, P = 0.001). The risk-adjusted rate of 1-year survival was 72.8% among patients with mild or no neurologic disability at discharge, as compared with 61.1% among patients with moderate neurologic disability, 42.2% among those with severe neurologic disability, and 10.2% among those in a coma or vegetative state (P<0.001 for all comparisons). Moreover, 1-year readmission rates were higher among patients who were black, those who were women, and those who had substantial neurologic disability (P<0.05 for all comparisons). These differences in survival and readmission rates persisted at 2 years. At 3 years, the rate of survival among survivors of in-hospital cardiac arrest was similar to that of patients who had been hospitalized with heart failure and were discharged alive (43.5% and 44.9%, respectively; risk ratio, 0.98; 95% confidence interval, 0.95 to 1.02; P = 0.35).
CONCLUSIONS
Among elderly survivors of in-hospital cardiac arrest, nearly 60% were alive at 1 year, and the rate of 3-year survival was similar to that among patients with heart failure. Survival and readmission rates differed according to the demographic characteristics of the patients and neurologic status at discharge. (Funded by the American Heart Association and the National Heart, Lung, and Blood Institute.)
doi:10.1056/NEJMoa1200657
PMCID: PMC3652256  PMID: 23484828
3.  Exposure to Low-Dose Ionizing Radiation from Medical Imaging Procedures in the United States 
The New England journal of medicine  2009;361(9):849-857.
Background
Growing use of imaging procedures in the United States has raised concerns about exposure to low-dose ionizing radiation in the general population.
Methods
We identified 952,420 non-elderly adults in 5 healthcare markets across the United States between July 1, 2005 and December 31, 2007. Utilization data were used to determine cumulative effective doses of radiation from imaging procedures in millisieverts (mSv) and to calculate population-based rates of “moderate” (>3 to 20 mSv per year), “high” (>20 to 50 mSv per year) and “very-high” (>50 mSv per year) doses.
Results
During the study period, 655,613 (68.8%) individuals underwent at least 1 imaging procedure associated with radiation exposure. The mean effective dose from imaging procedures was 2.4 mSv per person per year (std dev, 6.0 mSv); however, a wide distribution was noted with a median effective dose of 0.1 mSv per person per year (interquartile range, 0.0 to 1.7). Overall, the annual rate for moderate effective doses in the study population was 193.8 per 1000 enrollees, while high and very-high doses occurred at annual rates of 18.6 per 1000 enrollees and 1.9 per 1000 enrollees, respectively. In general, effective doses of radiation from imaging procedures increased with advancing age and were higher in women. Computed tomography and nuclear medicine scans accounted for 75.4% of the total effective dose and 81.8% occurred in non-hospitalized settings.
Conclusions
Imaging procedures are an important source of ionizing radiation in the United States and can lead to high radiation doses in patients.
doi:10.1056/NEJMoa0901249
PMCID: PMC3707303  PMID: 19710483
4.  Post-Hospital Syndrome – A Condition of Generalized Risk 
The New England journal of medicine  2013;368(2):100-102.
doi:10.1056/NEJMp1212324
PMCID: PMC3688067  PMID: 23301730
5.  Trends in Survival After In-Hospital Cardiac Arrest 
The New England journal of medicine  2012;367(20):1912-1920.
BACKGROUND
Despite numerous advances in resuscitation care in recent years, it remains unknown whether survival and neurological function after in-hospital cardiac arrest has improved over time.
METHODS
We identified all adults with an index in-hospital cardiac arrest at 374 hospitals in the Get With The Guidelines-Resuscitation registry between 2000 and 2009. Using multivariable regression, we examined temporal trends in risk-adjusted rates of survival to discharge. Additional analyses explored whether trends: (1) were due to improved survival during the acute resuscitation or post-resuscitation care and (2) occurred at the expense of greater neurological disability among survivors.
RESULTS
Among 84,625 hospitalized patients with cardiac arrest, 67,135 (79.3%) had an initial rhythm of asystole or pulseless electrical activity while 17,490 (20.7%) had ventricular fibrillation or pulseless ventricular tachycardia. The proportion of cardiac arrests due to asystole or pulseless electrical activity increased over time (P for trend <0.001). Risk-adjusted rates of survival to discharge in the overall cohort increased from 13.7% in 2000 to 22.4% in 2009 (adjusted rate-ratio per 1-year: 1.04, 95% CI [1.02–1.05]; P for trend <0.001). Survival improvement was similar in both rhythm groups and largely due to improved survival from the acute resuscitation (risk-adjusted rates: 42.7% in 2000, 54.1% in 2009; adjusted rate-ratio per 1-year: 1.03, 95% CI [1.02–1.04]; P for trend <0.001). Importantly, rates of neurological disability among survivors decreased over time (risk-adjusted rates: 32.9% in 2000, 28.1% in 2009; P for trend=0.02).
CONCLUSIONS
Both survival and neurological outcomes after in-hospital cardiac arrest have improved over the past decade.
doi:10.1056/NEJMoa1109148
PMCID: PMC3517894  PMID: 23150959
7.  Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies 
The New England journal of medicine  2012;366(24):2284-2293.
BACKGROUND
The upcoming reauthorization of the Prescription Drug User Fee Act focuses on improving the review process for new drug applications at the Food and Drug Administration (FDA).
METHODS
Using publicly available information from the FDA, the European Medicines Agency (EMA), and Health Canada, we compared the time for completion of the first review and the total review time for all applications involving novel therapeutic agents approved by the three regulatory agencies from 2001 through 2010 and determined the geographic area in which each novel therapeutic agent was first approved for use.
RESULTS
There were 510 applications for novel therapeutic agents approved from 2001 through 2010 — 225 by the FDA, 186 by the EMA, and 99 by Health Canada; among the applications, there were 289 unique agents. The median length of time for completion of the first review was 303 days (interquartile range, 185 to 372) for applications approved by the FDA, 366 days (interquartile range, 310 to 445) for those approved by the EMA, and 352 days (interquartile range, 255 to 420) for those approved by Health Canada (P<0.001 for the comparison across the three agencies). The median total review time was also shorter at the FDA than at the EMA or Health Canada (P = 0.002). Among the 289 unique novel therapeutic agents, 190 were approved in both the United States and Europe (either by the EMA or through the mutual recognition process), of which 121 (63.7%) were first approved in the United States; similarly, 154 were approved in both the United States and Canada, of which 132 (85.7%) were first approved in the United States.
CONCLUSIONS
For novel therapeutic agents approved between 2001 and 2010, the FDA reviewed applications involving novel therapeutics more quickly, on average, than did the EMA or Health Canada, and the vast majority of these new therapeutic agents were first approved for use in the United States. (Funded by the Pew Charitable Trusts.)
doi:10.1056/NEJMsa1200223
PMCID: PMC3504361  PMID: 22591257
8.  Telemonitoring in Patients with Heart Failure 
The New England journal of medicine  2010;363(24):2301-2309.
BACKGROUND
Small studies suggest that telemonitoring may improve heart-failure outcomes, but its effect in a large trial has not been established.
METHODS
We randomly assigned 1653 patients who had recently been hospitalized for heart failure to undergo either telemonitoring (826 patients) or usual care (827 patients). Telemonitoring was accomplished by means of a telephone-based interactive voice-response system that collected daily information about symptoms and weight that was reviewed by the patients’ clinicians. The primary end point was readmission for any reason or death from any cause within 180 days after enrollment. Secondary end points included hospitalization for heart failure, number of days in the hospital, and number of hospitalizations.
RESULTS
The median age of the patients was 61 years; 42.0% were female, and 39.0% were black. The telemonitoring group and the usual-care group did not differ significantly with respect to the primary end point, which occurred in 52.3% and 51.5% of patients, respectively (difference, 0.8 percentage points; 95% confidence interval [CI], −4.0 to 5.6; P = 0.75 by the chi-square test). Readmission for any reason occurred in 49.3% of patients in the telemonitoring group and 47.4% of patients in the usual-care group (difference, 1.9 percentage points; 95% CI, −3.0 to 6.7; P = 0.45 by the chi-square test). Death occurred in 11.1% of the telemonitoring group and 11.4% of the usual care group (difference, −0.2 percentage points; 95% CI, −3.3 to 2.8; P = 0.88 by the chi-square test). There were no significant differences between the two groups with respect to the secondary end points or the time to the primary end point or its components. No adverse events were reported.
CONCLUSIONS
Among patients recently hospitalized for heart failure, telemonitoring did not improve outcomes. The results indicate the importance of a thorough, independent evaluation of disease-management strategies before their adoption. (Funded by the National Heart, Lung, and Blood Institute; ClinicalTrials.gov number, NCT00303212.)
doi:10.1056/NEJMoa1010029
PMCID: PMC3237394  PMID: 21080835
9.  Hospital Volume and 30-Day Mortality for Three Common Medical Conditions 
The New England journal of medicine  2010;362(12):1110-1118.
Background
The association between hospital volume and the death rate for patients who are hospitalized for acute myocardial infarction, heart failure, or pneumonia remains unclear. It is also not known whether a volume threshold for such an association exists.
Methods
We conducted cross-sectional analyses of data from Medicare administrative claims for all fee-for-service beneficiaries who were hospitalized between 2004 and 2006 in acute care hospitals in the United States for acute myocardial infarction, heart failure, or pneumonia. Using hierarchical logistic-regression models for each condition, we estimated the change in the odds of death within 30 days associated with an increase of 100 patients in the annual hospital volume. Analyses were adjusted for patients’ risk factors and hospital characteristics. Bootstrapping procedures were used to estimate 95% confidence intervals to identify the condition-specific volume thresholds above which an increased volume was not associated with reduced mortality.
Results
There were 734,972 hospitalizations for acute myocardial infarction in 4128 hospitals, 1,324,287 for heart failure in 4679 hospitals, and 1,418,252 for pneumonia in 4673 hospitals. An increased hospital volume was associated with reduced 30-day mortality for all conditions (P<0.001 for all comparisons). For each condition, the association between volume and outcome was attenuated as the hospital's volume increased. For acute myocardial infarction, once the annual volume reached 610 patients (95% confidence interval [CI], 539 to 679), an increase in the hospital volume by 100 patients was no longer significantly associated with reduced odds of death. The volume threshold was 500 patients (95% CI, 433 to 566) for heart failure and 210 patients (95% CI, 142 to 284) for pneumonia.
Conclusions
Admission to higher-volume hospitals was associated with a reduction in mortality for acute myocardial infarction, heart failure, and pneumonia, although there was a volume threshold above which an increased condition-specific hospital volume was no longer significantly associated with reduced mortality.
doi:10.1056/NEJMsa0907130
PMCID: PMC2880468  PMID: 20335587
10.  Sex and Racial Differences in the Management of Acute Myocardial Infarction, 1994 through 2002 
The New England journal of medicine  2005;353(7):671-682.
BACKGROUND
Although increased attention has been paid to sex and racial differences in the management of myocardial infarction, it is unknown whether these differences have narrowed over time.
METHODS
With the use of data from the National Registry of Myocardial Infarction, we examined sex and racial differences in the treatment of patients who were deemed to be “ideal candidates” for particular treatments and in deaths among 598,911 patients hospitalized with myocardial infarction between 1994 and 2002.
RESULTS
In the unadjusted analysis, sex and racial differences were observed for rates of reperfusion therapy (for white men, white women, black men, and black women: 86.5, 83.3, 80.4, and 77.8 percent, respectively; P<0.001), use of aspirin (84.4, 78.7, 83.7, and 78.4 percent, respectively; P<0.001), use of beta-blockers (66.6, 62.9, 67.8, and 64.5 percent; P<0.001), and coronary angiography (69.1, 55.9, 64.0, and 55.0 percent; P<0.001). After multivariable adjustment, racial and sex differences persisted for rates of reperfusion therapy (risk ratio for white women, black men, and black women: 0.97, 0.91, and 0.89, respectively, as compared with white men) and coronary angiography (relative risk, 0.91, 0.82, and 0.76) but were attenuated for the use of aspirin (risk ratio, 0.97, 0.98, and 0.94) and beta-blockers (risk ratio, 0.98, 1.00, and 0.96); all risks were unchanged over time. Adjusted in-hospital mortality was similar among white women (risk ratio, 1.05; 95 percent confidence interval, 1.03 to 1.07) and black men (risk ratio, 0.95; 95 percent confidence interval, 0.89 to 1.00), as compared with white men, but was higher among black women (risk ratio, 1.11; 95 percent confidence interval, 1.06 to 1.16) and was unchanged over time.
CONCLUSIONS
Rates of reperfusion therapy, coronary angiography, and in-hospital death after myocardial infarction, but not the use of aspirin and beta-blockers, vary according to race and sex, with no evidence that the differences have narrowed in recent years.
doi:10.1056/NEJMsa032214
PMCID: PMC2805130  PMID: 16107620

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