Mitchel is a reporter for MDedge based in the Philadelphia area. He started with the company in 1992, when it was International Medical News Group (IMNG), and has since covered a range of medical specialties. Mitchel trained as a virologist at Roswell Park Memorial Institute in Buffalo, and then worked briefly as a researcher at Boston Children's Hospital before pivoting to journalism as a AAAS Mass Media Fellow in 1980. His first reporting job was with Science Digest magazine, and from the mid-1980s to early-1990s he was a reporter with Medical World News. @mitchelzoler

New Stent Showed Good Long-Term Safety

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New Stent Showed Good Long-Term Safety

NEW ORLEANS – Presuming that the Resolute zotarolimus-eluting coronary stent enters the U.S. market within the next year, interventionalists likely will rely on data from two key studies to weigh how it matches up against its main competition, the Xience V/Promus everolimus-eluting coronary stent.

Two features seemed to especially capture the attention of the cardiologists who reported the data at the meeting and those who heard it: the impressive performance of the zotarolimus-eluting stent (ZES) in patients with diabetes, and the long-term safety of the ZES compared with the everolimus-eluting stent (EES) for stent thrombosis.

One of the two studies was the RESOLUTE All Comers trial, which compared the ZES against the EES in a randomized trial of 2,292 European patients for whom follow-up now extends to 2 years.

The second study, RESOLUTE US, evaluated the new ZES in a series of 1,402 U.S. patients with a high, 34% prevalence of diabetes; this study had a special focus on the stent's performance in the 150 narrow, 2.25-mm-diameter arteries included in the series.

The roughly 2,500 ZES recipients included in these two studies form about half of the 5,227 total–patient worldwide experience with the stent to date, and constituted what Medronic, the company developing the Resolute ZES, submitted to the Food and Drug Administration for marketing approval and labeling.

One major take on these data by experts was that the ZES showed good overall performance that matched well with the performance of the EES.

The two stents “seemed to be fairly equivalent for most of the important safety and efficacy metrics. They are both superb,” said Dr. Martin B. Leon, director of the center for interventional vascular therapy at Columbia University in New York, and lead investigator for the RESOLUTE US study.

But other interventionalists hearing the data from both studies weren't as completely convinced.

“My initial take on the data is that [the ZES] doesn't seem to be better than the Xience stent, which is a very good stent and the dominant stent we use [in the United States] at this time,” Dr. Abhiram Prasad, an interventional cardiologist and professor of medicine at the Mayo Clinic in Rochester, Minn., said in an interview.

Safety concerns with the ZES date back to the initial, 12-month follow-up report, the first indication that the ZES fell short compared with the EES on the rate of stent thrombosis in the RESOLUTE All Comers trial. The New England Journal of Medicine report last year (2010;363:136-46) documented 18 patients (1.6%) with definite or probable stent thrombosis in the ZES arm, compared with 8 cases (0.7%) of definite or probable stent thrombosis in the EES group, a significant difference.

The new, 24-month follow-up data provided some reassurance on safety, in that the stent thrombosis gap between the two stents stayed stable. During an extra year of follow-up, three new cases of definite or probable stent thrombosis occurred in each of the two treatment arms, said Dr. Patrick W. Serruys, professor of interventional cardiology at Erasmus University and the Thoraxcentrum, Rotterdam, and lead investigator for the RESOLUTE All Comers trial. Aside from this one early safety deviation, the ZES and EES continued to show virtually identical efficacy performance through the 2 years of study, he showed in the updated data. Concurrently with his report at the meeting, the results appeared in an article published in the Lancet (2011 [doi:10. 1016/S0140 6736(11)60404-2]).

Dr. Serruys, as well as others, chalked up the early difference in stent thrombosis rates to chance, and to some isolated poor performance in certain sites undertaking the coronary interventions.

“Numerically, the stent thrombosis is very small, a difference of 21 vs. 11 patients in more than 2,000 total patients. It could be the play of chance,” Dr. Serruys said.

The RESOLUTE US results seemed to add to the safety assurance. In those 1,402 patients, two cases (0.1%) of stent thrombosis occurred during 12 months of tracking. Concurrently with Dr. Leon's report, the RESOLUTE US results appeared in the Journal of the American College of Cardiology (2011 April 4 [doi:10.1016/j.jacc.2011.03.005]).

“This is one of the lowest 1-year stent thrombosis rates ever reported,” noted Dr. Leon. “I take from this that it's a safe stent.”

The pattern of some of the earliest cases of stent thrombosis in RESOLUTE All Comers suggested that it may have been caused more by operator failings and less by problems with the stent itself. During the study's first 30 days, stent thrombosis occurred in nine ZES patients and one EES patient, making up most of the differential that wound up haunting the ZES arm through the next 2 years. “Stent thrombosis during the first 30 days is procedure related,” and generally the stent itself plays no role, said Dr. Alan C. Yeung, professor of medicine and director of cardiac catheterization at Stanford (Calif.) University.

 

 

“Whether it's a real difference or a play of chance remains undetermined,” commented Dr. Mitchell W. Krucoff, a professor of medicine and interventional cardiologist at Duke University in Durham, N.C. “These types of differences [21 patients vs. 11 patients] are not certain at a statistical level.”

So if the ZES hopes to wrest any market share from the EES when it hits the U.S. market, it may need to have something to distinguish it, and that something may be an FDA-approved indication for treatment of coronary stenoses in patients with diabetes. At least that's what Medtronic is hoping for. The company included that application in its submission to the FDA, Jason Fontana, Ph.D., senior director for clinical communication at Medtronic, said in an interview.

“The diabetes subgroup was large enough, and the diabetes analysis was prespecified” in RESOLUTE US, Dr. Leon said in an interview. “If you include this subgroup, and the RESOLUTE All Comers diabetes subgroup, you have a robust enough population to justify consideration for approval, I think,” he said.

“The results were quite substantial,” with a 3.0% rate of target-lesion revascularization among the patients with diabetes, compared with a 2.0% rate for the entire main cohort of the study.”

But even if the diabetes indication works out, will interventionalists be swayed by that, or by the data?

“An issue is, to what extent can a single trial address a subgroup?” said Dr. Krucoff. “To what degree is there statistical guidance that in the real world [the ZES] would live up to this measure?”

“I don't think I'd put a lot of emphasis in my decision making on the [RESOLUTE US] data, because a problem with all [stenting] studies is that the rates are constantly improving, so the new device can appear to be better. … Even if [the ZES] was approved for use in patients with diabetes, I don't think in my practice I'd pick it to use in those patients. They'd need to do a randomized study in patients with diabetes to convince me” that it was better than the EES, Dr. Prasad said.

Dr. Serruys and Dr. Prasad had no relevant financial disclosures. Dr. Leon serves as an unpaid consultant to Abbott, Boston Scientific, and Medtronic. Dr. Yeung serves on the scientific advisory board of Medtronic; he is also a consultant for Abbott Vascular, Boston Scientific, and Cordis, and has received research grants from Boston Scientific, Edwards, and Medtronic. Dr. Fontana is an employee of Medtronic. Dr. Krucoff has been a consultant to or has received honoraria from Abbott, Biosensors, Cardiomind, Cordis Johnson & Johnson, Medtronic, Merck, Micelle, OrbusNeich, Prescient, Sanofi-Aventis, and Terumo.

'The results were quite substantial,' with a 3.0% rate of target-lesion revascularization among diabetes patients.

Source DR. LEON

The ZES and EES continued to show virtually identical efficacy performance through the 2 years of study.

Source DR. SERRUYS

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NEW ORLEANS – Presuming that the Resolute zotarolimus-eluting coronary stent enters the U.S. market within the next year, interventionalists likely will rely on data from two key studies to weigh how it matches up against its main competition, the Xience V/Promus everolimus-eluting coronary stent.

Two features seemed to especially capture the attention of the cardiologists who reported the data at the meeting and those who heard it: the impressive performance of the zotarolimus-eluting stent (ZES) in patients with diabetes, and the long-term safety of the ZES compared with the everolimus-eluting stent (EES) for stent thrombosis.

One of the two studies was the RESOLUTE All Comers trial, which compared the ZES against the EES in a randomized trial of 2,292 European patients for whom follow-up now extends to 2 years.

The second study, RESOLUTE US, evaluated the new ZES in a series of 1,402 U.S. patients with a high, 34% prevalence of diabetes; this study had a special focus on the stent's performance in the 150 narrow, 2.25-mm-diameter arteries included in the series.

The roughly 2,500 ZES recipients included in these two studies form about half of the 5,227 total–patient worldwide experience with the stent to date, and constituted what Medronic, the company developing the Resolute ZES, submitted to the Food and Drug Administration for marketing approval and labeling.

One major take on these data by experts was that the ZES showed good overall performance that matched well with the performance of the EES.

The two stents “seemed to be fairly equivalent for most of the important safety and efficacy metrics. They are both superb,” said Dr. Martin B. Leon, director of the center for interventional vascular therapy at Columbia University in New York, and lead investigator for the RESOLUTE US study.

But other interventionalists hearing the data from both studies weren't as completely convinced.

“My initial take on the data is that [the ZES] doesn't seem to be better than the Xience stent, which is a very good stent and the dominant stent we use [in the United States] at this time,” Dr. Abhiram Prasad, an interventional cardiologist and professor of medicine at the Mayo Clinic in Rochester, Minn., said in an interview.

Safety concerns with the ZES date back to the initial, 12-month follow-up report, the first indication that the ZES fell short compared with the EES on the rate of stent thrombosis in the RESOLUTE All Comers trial. The New England Journal of Medicine report last year (2010;363:136-46) documented 18 patients (1.6%) with definite or probable stent thrombosis in the ZES arm, compared with 8 cases (0.7%) of definite or probable stent thrombosis in the EES group, a significant difference.

The new, 24-month follow-up data provided some reassurance on safety, in that the stent thrombosis gap between the two stents stayed stable. During an extra year of follow-up, three new cases of definite or probable stent thrombosis occurred in each of the two treatment arms, said Dr. Patrick W. Serruys, professor of interventional cardiology at Erasmus University and the Thoraxcentrum, Rotterdam, and lead investigator for the RESOLUTE All Comers trial. Aside from this one early safety deviation, the ZES and EES continued to show virtually identical efficacy performance through the 2 years of study, he showed in the updated data. Concurrently with his report at the meeting, the results appeared in an article published in the Lancet (2011 [doi:10. 1016/S0140 6736(11)60404-2]).

Dr. Serruys, as well as others, chalked up the early difference in stent thrombosis rates to chance, and to some isolated poor performance in certain sites undertaking the coronary interventions.

“Numerically, the stent thrombosis is very small, a difference of 21 vs. 11 patients in more than 2,000 total patients. It could be the play of chance,” Dr. Serruys said.

The RESOLUTE US results seemed to add to the safety assurance. In those 1,402 patients, two cases (0.1%) of stent thrombosis occurred during 12 months of tracking. Concurrently with Dr. Leon's report, the RESOLUTE US results appeared in the Journal of the American College of Cardiology (2011 April 4 [doi:10.1016/j.jacc.2011.03.005]).

“This is one of the lowest 1-year stent thrombosis rates ever reported,” noted Dr. Leon. “I take from this that it's a safe stent.”

The pattern of some of the earliest cases of stent thrombosis in RESOLUTE All Comers suggested that it may have been caused more by operator failings and less by problems with the stent itself. During the study's first 30 days, stent thrombosis occurred in nine ZES patients and one EES patient, making up most of the differential that wound up haunting the ZES arm through the next 2 years. “Stent thrombosis during the first 30 days is procedure related,” and generally the stent itself plays no role, said Dr. Alan C. Yeung, professor of medicine and director of cardiac catheterization at Stanford (Calif.) University.

 

 

“Whether it's a real difference or a play of chance remains undetermined,” commented Dr. Mitchell W. Krucoff, a professor of medicine and interventional cardiologist at Duke University in Durham, N.C. “These types of differences [21 patients vs. 11 patients] are not certain at a statistical level.”

So if the ZES hopes to wrest any market share from the EES when it hits the U.S. market, it may need to have something to distinguish it, and that something may be an FDA-approved indication for treatment of coronary stenoses in patients with diabetes. At least that's what Medtronic is hoping for. The company included that application in its submission to the FDA, Jason Fontana, Ph.D., senior director for clinical communication at Medtronic, said in an interview.

“The diabetes subgroup was large enough, and the diabetes analysis was prespecified” in RESOLUTE US, Dr. Leon said in an interview. “If you include this subgroup, and the RESOLUTE All Comers diabetes subgroup, you have a robust enough population to justify consideration for approval, I think,” he said.

“The results were quite substantial,” with a 3.0% rate of target-lesion revascularization among the patients with diabetes, compared with a 2.0% rate for the entire main cohort of the study.”

But even if the diabetes indication works out, will interventionalists be swayed by that, or by the data?

“An issue is, to what extent can a single trial address a subgroup?” said Dr. Krucoff. “To what degree is there statistical guidance that in the real world [the ZES] would live up to this measure?”

“I don't think I'd put a lot of emphasis in my decision making on the [RESOLUTE US] data, because a problem with all [stenting] studies is that the rates are constantly improving, so the new device can appear to be better. … Even if [the ZES] was approved for use in patients with diabetes, I don't think in my practice I'd pick it to use in those patients. They'd need to do a randomized study in patients with diabetes to convince me” that it was better than the EES, Dr. Prasad said.

Dr. Serruys and Dr. Prasad had no relevant financial disclosures. Dr. Leon serves as an unpaid consultant to Abbott, Boston Scientific, and Medtronic. Dr. Yeung serves on the scientific advisory board of Medtronic; he is also a consultant for Abbott Vascular, Boston Scientific, and Cordis, and has received research grants from Boston Scientific, Edwards, and Medtronic. Dr. Fontana is an employee of Medtronic. Dr. Krucoff has been a consultant to or has received honoraria from Abbott, Biosensors, Cardiomind, Cordis Johnson & Johnson, Medtronic, Merck, Micelle, OrbusNeich, Prescient, Sanofi-Aventis, and Terumo.

'The results were quite substantial,' with a 3.0% rate of target-lesion revascularization among diabetes patients.

Source DR. LEON

The ZES and EES continued to show virtually identical efficacy performance through the 2 years of study.

Source DR. SERRUYS

NEW ORLEANS – Presuming that the Resolute zotarolimus-eluting coronary stent enters the U.S. market within the next year, interventionalists likely will rely on data from two key studies to weigh how it matches up against its main competition, the Xience V/Promus everolimus-eluting coronary stent.

Two features seemed to especially capture the attention of the cardiologists who reported the data at the meeting and those who heard it: the impressive performance of the zotarolimus-eluting stent (ZES) in patients with diabetes, and the long-term safety of the ZES compared with the everolimus-eluting stent (EES) for stent thrombosis.

One of the two studies was the RESOLUTE All Comers trial, which compared the ZES against the EES in a randomized trial of 2,292 European patients for whom follow-up now extends to 2 years.

The second study, RESOLUTE US, evaluated the new ZES in a series of 1,402 U.S. patients with a high, 34% prevalence of diabetes; this study had a special focus on the stent's performance in the 150 narrow, 2.25-mm-diameter arteries included in the series.

The roughly 2,500 ZES recipients included in these two studies form about half of the 5,227 total–patient worldwide experience with the stent to date, and constituted what Medronic, the company developing the Resolute ZES, submitted to the Food and Drug Administration for marketing approval and labeling.

One major take on these data by experts was that the ZES showed good overall performance that matched well with the performance of the EES.

The two stents “seemed to be fairly equivalent for most of the important safety and efficacy metrics. They are both superb,” said Dr. Martin B. Leon, director of the center for interventional vascular therapy at Columbia University in New York, and lead investigator for the RESOLUTE US study.

But other interventionalists hearing the data from both studies weren't as completely convinced.

“My initial take on the data is that [the ZES] doesn't seem to be better than the Xience stent, which is a very good stent and the dominant stent we use [in the United States] at this time,” Dr. Abhiram Prasad, an interventional cardiologist and professor of medicine at the Mayo Clinic in Rochester, Minn., said in an interview.

Safety concerns with the ZES date back to the initial, 12-month follow-up report, the first indication that the ZES fell short compared with the EES on the rate of stent thrombosis in the RESOLUTE All Comers trial. The New England Journal of Medicine report last year (2010;363:136-46) documented 18 patients (1.6%) with definite or probable stent thrombosis in the ZES arm, compared with 8 cases (0.7%) of definite or probable stent thrombosis in the EES group, a significant difference.

The new, 24-month follow-up data provided some reassurance on safety, in that the stent thrombosis gap between the two stents stayed stable. During an extra year of follow-up, three new cases of definite or probable stent thrombosis occurred in each of the two treatment arms, said Dr. Patrick W. Serruys, professor of interventional cardiology at Erasmus University and the Thoraxcentrum, Rotterdam, and lead investigator for the RESOLUTE All Comers trial. Aside from this one early safety deviation, the ZES and EES continued to show virtually identical efficacy performance through the 2 years of study, he showed in the updated data. Concurrently with his report at the meeting, the results appeared in an article published in the Lancet (2011 [doi:10. 1016/S0140 6736(11)60404-2]).

Dr. Serruys, as well as others, chalked up the early difference in stent thrombosis rates to chance, and to some isolated poor performance in certain sites undertaking the coronary interventions.

“Numerically, the stent thrombosis is very small, a difference of 21 vs. 11 patients in more than 2,000 total patients. It could be the play of chance,” Dr. Serruys said.

The RESOLUTE US results seemed to add to the safety assurance. In those 1,402 patients, two cases (0.1%) of stent thrombosis occurred during 12 months of tracking. Concurrently with Dr. Leon's report, the RESOLUTE US results appeared in the Journal of the American College of Cardiology (2011 April 4 [doi:10.1016/j.jacc.2011.03.005]).

“This is one of the lowest 1-year stent thrombosis rates ever reported,” noted Dr. Leon. “I take from this that it's a safe stent.”

The pattern of some of the earliest cases of stent thrombosis in RESOLUTE All Comers suggested that it may have been caused more by operator failings and less by problems with the stent itself. During the study's first 30 days, stent thrombosis occurred in nine ZES patients and one EES patient, making up most of the differential that wound up haunting the ZES arm through the next 2 years. “Stent thrombosis during the first 30 days is procedure related,” and generally the stent itself plays no role, said Dr. Alan C. Yeung, professor of medicine and director of cardiac catheterization at Stanford (Calif.) University.

 

 

“Whether it's a real difference or a play of chance remains undetermined,” commented Dr. Mitchell W. Krucoff, a professor of medicine and interventional cardiologist at Duke University in Durham, N.C. “These types of differences [21 patients vs. 11 patients] are not certain at a statistical level.”

So if the ZES hopes to wrest any market share from the EES when it hits the U.S. market, it may need to have something to distinguish it, and that something may be an FDA-approved indication for treatment of coronary stenoses in patients with diabetes. At least that's what Medtronic is hoping for. The company included that application in its submission to the FDA, Jason Fontana, Ph.D., senior director for clinical communication at Medtronic, said in an interview.

“The diabetes subgroup was large enough, and the diabetes analysis was prespecified” in RESOLUTE US, Dr. Leon said in an interview. “If you include this subgroup, and the RESOLUTE All Comers diabetes subgroup, you have a robust enough population to justify consideration for approval, I think,” he said.

“The results were quite substantial,” with a 3.0% rate of target-lesion revascularization among the patients with diabetes, compared with a 2.0% rate for the entire main cohort of the study.”

But even if the diabetes indication works out, will interventionalists be swayed by that, or by the data?

“An issue is, to what extent can a single trial address a subgroup?” said Dr. Krucoff. “To what degree is there statistical guidance that in the real world [the ZES] would live up to this measure?”

“I don't think I'd put a lot of emphasis in my decision making on the [RESOLUTE US] data, because a problem with all [stenting] studies is that the rates are constantly improving, so the new device can appear to be better. … Even if [the ZES] was approved for use in patients with diabetes, I don't think in my practice I'd pick it to use in those patients. They'd need to do a randomized study in patients with diabetes to convince me” that it was better than the EES, Dr. Prasad said.

Dr. Serruys and Dr. Prasad had no relevant financial disclosures. Dr. Leon serves as an unpaid consultant to Abbott, Boston Scientific, and Medtronic. Dr. Yeung serves on the scientific advisory board of Medtronic; he is also a consultant for Abbott Vascular, Boston Scientific, and Cordis, and has received research grants from Boston Scientific, Edwards, and Medtronic. Dr. Fontana is an employee of Medtronic. Dr. Krucoff has been a consultant to or has received honoraria from Abbott, Biosensors, Cardiomind, Cordis Johnson & Johnson, Medtronic, Merck, Micelle, OrbusNeich, Prescient, Sanofi-Aventis, and Terumo.

'The results were quite substantial,' with a 3.0% rate of target-lesion revascularization among diabetes patients.

Source DR. LEON

The ZES and EES continued to show virtually identical efficacy performance through the 2 years of study.

Source DR. SERRUYS

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Blood Cultures Help Assess Selected Children With Pneumonia

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PHILADELPHIA – Children who present to the emergency department with mild community-acquired pneumonia probably do not require a routine blood culture, but blood cultures can help in the management of children with moderate to severe pneumonia, based on a review of 291 patients.

"The benefit of blood cultures is likely limited to the patient subgroups who are at increased risk for bacteremia," Maria H. Dugan said at the annual meeting of the Eastern Society for Pediatric Research. In the study population, bacteremia occurred with a significantly higher prevalence in patients with pneumonia complications, especially pulmonary complications, said Ms. Dugan, a researcher at Children’s Hospital of Philadelphia (CHOP).

Maria H. Dugan    

The analysis also showed that in five of the six pneumonia patients in the series identified as having bacteremia, the culture results led to a change in management.

"Even though blood cultures were infrequently positive, the positive results often led to meaningful changes in clinical management," said Dr. Samir S. Shah, a pediatric infectious diseases physician at CHOP and the senior investigator for this study. "Equally important, those children with more severe forms of pneumonia, such as empyema, had fairly high rates of bacteremia, about 13%. We think this is sufficiently high to warrant a blood culture," he said in an interview.

Ms. Dugan and her associates performed this analysis because blood cultures are often obtained from children who present to an emergency department with community-acquired pneumonia, even though blood cultures rarely influence the management of adults with pneumonia. The study tried to assess the impact that culture results have on management in children.

"In studies of adults with pneumonia, investigators have found that blood cultures were uncommonly positive, and that even when blood cultures were positive, physicians seldom did anything different as a result. We found a very different story in children," Dr. Shah said.

The investigators’ review included children aged 0-18 from 35 primary care pediatric practices affiliated with CHOP in Pennsylvania, New Jersey, and Delaware who were seen in the emergency department at CHOP during 2006 or 2007 with a discharge diagnosis of pneumonia. The 877 patients evaluated in the emergency department averaged 4 years old, with 78% aged 5 or younger.

The emergency department staff obtained blood cultures on 291 (34%) of the 877 children with pneumonia. The decision of whether to obtain a culture rested solely with the physicians who cared for each child. "There is no protocol [at CHOP] regarding the decision to obtain blood cultures in children with pneumonia," Dr. Shah explained. "We suspect that blood cultures were more commonly obtained in children with a higher degree of illness severity."

Comparison of the children who underwent culturing and those who did not showed that the cultured children were older, with 38% older than 5 years, compared with 13% in this age range among those who were not cultured. Greater disease severity also appeared to distinguish the children who underwent culturing. The cultured children had a higher prevalence of hypoxia, and more often their records said that they appeared ill at presentation, compared with the children who did not undergo culturing, Dr. Shah said.

Six (2%) of the 291 children tested by culturing had a confirmed positive culture. Three additional cultures initially tested positive, but subsequent study showed contaminations that made these cultures false positives. The six true-positive cultures included four with Streptococcus pneumoniae, one with Staphylococcus aureus, and one with Haemophilus influenzae.

Patients with an infiltrate on their chest x-ray, and patients who eventually required hospitalization did not have a significantly higher prevalence of a positive culture compared with the other children. But the analysis showed a statistically significant higher level of positive cultures among the children who presented with any pneumonia complication (8%), and especially in those with pulmonary complications (13%).

For four (1.4%) children, results from the blood culture led the hospital staff to narrow their antibiotic treatment compared with the initial treatment the children received, and in two cases (0.7%) the culture results led to a broadening of the antibiotic coverage. In one of these patients, the culture results led to both broadening and narrowing of the treatment regimen. Dr. Shah explained that in this case when the culture initially showed positive, the medical staff broadened the child’s antibiotic coverage. Soon after, when they had identified the specific pathogen as S. pneumoniae, the staff narrowed the antibiotic treatment. For the sixth patient, the blood culture results led to no change from the initial, empiric regimen. This patient had responded well to the initial regimen of amoxicillin, and was subsequently found infected by an S. pneumoniae strain sensitive to amoxicillin, so no change occurred, Dr. Shah said.

 

 

Ms. Dugan and Dr. Shah said that they had no relevant financial disclosures.




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PHILADELPHIA – Children who present to the emergency department with mild community-acquired pneumonia probably do not require a routine blood culture, but blood cultures can help in the management of children with moderate to severe pneumonia, based on a review of 291 patients.

"The benefit of blood cultures is likely limited to the patient subgroups who are at increased risk for bacteremia," Maria H. Dugan said at the annual meeting of the Eastern Society for Pediatric Research. In the study population, bacteremia occurred with a significantly higher prevalence in patients with pneumonia complications, especially pulmonary complications, said Ms. Dugan, a researcher at Children’s Hospital of Philadelphia (CHOP).

Maria H. Dugan    

The analysis also showed that in five of the six pneumonia patients in the series identified as having bacteremia, the culture results led to a change in management.

"Even though blood cultures were infrequently positive, the positive results often led to meaningful changes in clinical management," said Dr. Samir S. Shah, a pediatric infectious diseases physician at CHOP and the senior investigator for this study. "Equally important, those children with more severe forms of pneumonia, such as empyema, had fairly high rates of bacteremia, about 13%. We think this is sufficiently high to warrant a blood culture," he said in an interview.

Ms. Dugan and her associates performed this analysis because blood cultures are often obtained from children who present to an emergency department with community-acquired pneumonia, even though blood cultures rarely influence the management of adults with pneumonia. The study tried to assess the impact that culture results have on management in children.

"In studies of adults with pneumonia, investigators have found that blood cultures were uncommonly positive, and that even when blood cultures were positive, physicians seldom did anything different as a result. We found a very different story in children," Dr. Shah said.

The investigators’ review included children aged 0-18 from 35 primary care pediatric practices affiliated with CHOP in Pennsylvania, New Jersey, and Delaware who were seen in the emergency department at CHOP during 2006 or 2007 with a discharge diagnosis of pneumonia. The 877 patients evaluated in the emergency department averaged 4 years old, with 78% aged 5 or younger.

The emergency department staff obtained blood cultures on 291 (34%) of the 877 children with pneumonia. The decision of whether to obtain a culture rested solely with the physicians who cared for each child. "There is no protocol [at CHOP] regarding the decision to obtain blood cultures in children with pneumonia," Dr. Shah explained. "We suspect that blood cultures were more commonly obtained in children with a higher degree of illness severity."

Comparison of the children who underwent culturing and those who did not showed that the cultured children were older, with 38% older than 5 years, compared with 13% in this age range among those who were not cultured. Greater disease severity also appeared to distinguish the children who underwent culturing. The cultured children had a higher prevalence of hypoxia, and more often their records said that they appeared ill at presentation, compared with the children who did not undergo culturing, Dr. Shah said.

Six (2%) of the 291 children tested by culturing had a confirmed positive culture. Three additional cultures initially tested positive, but subsequent study showed contaminations that made these cultures false positives. The six true-positive cultures included four with Streptococcus pneumoniae, one with Staphylococcus aureus, and one with Haemophilus influenzae.

Patients with an infiltrate on their chest x-ray, and patients who eventually required hospitalization did not have a significantly higher prevalence of a positive culture compared with the other children. But the analysis showed a statistically significant higher level of positive cultures among the children who presented with any pneumonia complication (8%), and especially in those with pulmonary complications (13%).

For four (1.4%) children, results from the blood culture led the hospital staff to narrow their antibiotic treatment compared with the initial treatment the children received, and in two cases (0.7%) the culture results led to a broadening of the antibiotic coverage. In one of these patients, the culture results led to both broadening and narrowing of the treatment regimen. Dr. Shah explained that in this case when the culture initially showed positive, the medical staff broadened the child’s antibiotic coverage. Soon after, when they had identified the specific pathogen as S. pneumoniae, the staff narrowed the antibiotic treatment. For the sixth patient, the blood culture results led to no change from the initial, empiric regimen. This patient had responded well to the initial regimen of amoxicillin, and was subsequently found infected by an S. pneumoniae strain sensitive to amoxicillin, so no change occurred, Dr. Shah said.

 

 

Ms. Dugan and Dr. Shah said that they had no relevant financial disclosures.




PHILADELPHIA – Children who present to the emergency department with mild community-acquired pneumonia probably do not require a routine blood culture, but blood cultures can help in the management of children with moderate to severe pneumonia, based on a review of 291 patients.

"The benefit of blood cultures is likely limited to the patient subgroups who are at increased risk for bacteremia," Maria H. Dugan said at the annual meeting of the Eastern Society for Pediatric Research. In the study population, bacteremia occurred with a significantly higher prevalence in patients with pneumonia complications, especially pulmonary complications, said Ms. Dugan, a researcher at Children’s Hospital of Philadelphia (CHOP).

Maria H. Dugan    

The analysis also showed that in five of the six pneumonia patients in the series identified as having bacteremia, the culture results led to a change in management.

"Even though blood cultures were infrequently positive, the positive results often led to meaningful changes in clinical management," said Dr. Samir S. Shah, a pediatric infectious diseases physician at CHOP and the senior investigator for this study. "Equally important, those children with more severe forms of pneumonia, such as empyema, had fairly high rates of bacteremia, about 13%. We think this is sufficiently high to warrant a blood culture," he said in an interview.

Ms. Dugan and her associates performed this analysis because blood cultures are often obtained from children who present to an emergency department with community-acquired pneumonia, even though blood cultures rarely influence the management of adults with pneumonia. The study tried to assess the impact that culture results have on management in children.

"In studies of adults with pneumonia, investigators have found that blood cultures were uncommonly positive, and that even when blood cultures were positive, physicians seldom did anything different as a result. We found a very different story in children," Dr. Shah said.

The investigators’ review included children aged 0-18 from 35 primary care pediatric practices affiliated with CHOP in Pennsylvania, New Jersey, and Delaware who were seen in the emergency department at CHOP during 2006 or 2007 with a discharge diagnosis of pneumonia. The 877 patients evaluated in the emergency department averaged 4 years old, with 78% aged 5 or younger.

The emergency department staff obtained blood cultures on 291 (34%) of the 877 children with pneumonia. The decision of whether to obtain a culture rested solely with the physicians who cared for each child. "There is no protocol [at CHOP] regarding the decision to obtain blood cultures in children with pneumonia," Dr. Shah explained. "We suspect that blood cultures were more commonly obtained in children with a higher degree of illness severity."

Comparison of the children who underwent culturing and those who did not showed that the cultured children were older, with 38% older than 5 years, compared with 13% in this age range among those who were not cultured. Greater disease severity also appeared to distinguish the children who underwent culturing. The cultured children had a higher prevalence of hypoxia, and more often their records said that they appeared ill at presentation, compared with the children who did not undergo culturing, Dr. Shah said.

Six (2%) of the 291 children tested by culturing had a confirmed positive culture. Three additional cultures initially tested positive, but subsequent study showed contaminations that made these cultures false positives. The six true-positive cultures included four with Streptococcus pneumoniae, one with Staphylococcus aureus, and one with Haemophilus influenzae.

Patients with an infiltrate on their chest x-ray, and patients who eventually required hospitalization did not have a significantly higher prevalence of a positive culture compared with the other children. But the analysis showed a statistically significant higher level of positive cultures among the children who presented with any pneumonia complication (8%), and especially in those with pulmonary complications (13%).

For four (1.4%) children, results from the blood culture led the hospital staff to narrow their antibiotic treatment compared with the initial treatment the children received, and in two cases (0.7%) the culture results led to a broadening of the antibiotic coverage. In one of these patients, the culture results led to both broadening and narrowing of the treatment regimen. Dr. Shah explained that in this case when the culture initially showed positive, the medical staff broadened the child’s antibiotic coverage. Soon after, when they had identified the specific pathogen as S. pneumoniae, the staff narrowed the antibiotic treatment. For the sixth patient, the blood culture results led to no change from the initial, empiric regimen. This patient had responded well to the initial regimen of amoxicillin, and was subsequently found infected by an S. pneumoniae strain sensitive to amoxicillin, so no change occurred, Dr. Shah said.

 

 

Ms. Dugan and Dr. Shah said that they had no relevant financial disclosures.




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Major Finding: Children with community-acquired pneumonia seen in the emergency department of an urban pediatric hospital had a 2% rate of positive blood cultures, but the prevalence of positive cultures increased among the subset of patients with pneumonia-related complications, especially pulmonary complications.

Data Source: Review of 291 children evaluated and cultured in the emergency department of a single medical center with a discharge diagnosis of community-acquired pneumonia during 2006 and 2007.

Disclosures: Ms. Dugan and Dr. Shah said they had no relevant financial disclosures.

Elective PCI: 12% of Cases Are Inappropriate

Cutting Inappropriate Cases Requires Better Documentation and Patient Selection
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NEW ORLEANS – About 12% of the more than 140,000 Americans who underwent elective coronary artery stenting during 2009-2010 had an inappropriate procedure, based on an analysis of data from a national coronary stent registry maintained by the American College of Cardiology.

In contrast, the rate of inappropriate procedures was 1% in the larger group of more than 355,000 patients who had an acute need for percutaneous coronary interventions (PCI) during the period studied, Dr. Paul S. Chan said at the annual meeting of the American College of Cardiology.

The analysis also showed a striking hospital-to-hospital variation in the rate of elective PCI cases flagged as inappropriate. About 25% of the hospitals doing elective cases had a rate below 6%; another quarter had a rate of 17% or higher. Yet some hospitals had inappropriate rates that exceeded 30%.

Dr. Paul S. Chan    

Starting in May 2011, the ACC will start reporting data from this analysis to each of the more than 1,000 participating U.S. hospitals. By carefully reviewing cases that have been flagged as inappropriate, it is hoped that hospitals will learn from their mistakes and drive down the inappropriate rate, especially for elective PCIs, said Dr. Chan, a cardiologist at the Mid-America Heart Institute of Saint Luke’s Hospital in Kansas City, Mo.

The ACC collects the PCI data through the CathPCI portion of its National Cardiovascular Data Registry (NCDR). Dr. Chan and his associates rated each procedure they reviewed as appropriate, inappropriate, or uncertain based on comprehensive criteria established by an ACC expert panel (J. Am. Coll. Card. 2009;53:530-53).

But even with feedback and review of inappropriate PCIs, the rate of these cases will probably never drop to zero, he said.

Other experts hailed the analysis and feedback program as an advance that will improve U.S. use of PCI, but they also cautioned that the findings must be interpreted carefully.

"About 25% of the interventional cases in my practice would be categorized as inappropriate," commented Dr. Edward J. McNulty, an interventional cardiologist at Kaiser Permanente in San Francisco. "I get most of my patients from surgeons or other interventional cardiologists who feel the patients are too high risk. I do a lot of left main and multivessel PCI. There is no way that I can explain on the NCDR form why I consider these patients appropriate. The NCDR data don’t allow you to appreciate nuances. The criteria tend to penalize physicians who deviate from the average [by performing] complex cases."

Additionally, the way patients’ drug use gets recorded on the day of hospitalization is problematic, as patients may stop a chronically-used drug on the day before entering the hospital and be erroneously recorded as not being on a therapy. Another issue is misclassification of symptoms, such as a patient who perceives ischemic chest pain as shortness of breath.

"I believe that inappropriate PCIs occur, and these results can certainly show signals. But within the ‘inappropriate’ procedures are some cases with mitigating circumstances," Dr. McNulty said in an interview.

"There are cases that you know are appropriate, but you can’t get at them adequately with the [NCDR] data forms," agreed Dr. William S. Weintraub, chief of cardiology at the Christiana Care Health System in Newark, Del. "We need to be very careful about what we say about any institution with inappropriate cases." The analysis results are best used to identify inappropriate cases to hospitals so that hospital staffs can closely study these cases, determine if they were truly inappropriate, and if so, to try to find the problems and fix them, Dr. Weintraub said in an interview.

The ACC expert panel published appropriateness criteria for 198 different clinical scenarios based on six separate clinical elements in February 2009. Dr. Chan and his associates applied the criteria to 500,154 U.S. cases that were treated with PCI during July 2009 through the end of September 2010. The criteria sorted cases into three categories: appropriate, inappropriate, or uncertain. Inappropriate cases were situations where the expected negative consequences of the procedure exceeded the expected benefits.

PCI performed for an acute problem (such as high-risk unstable angina or MI) occurred in 71% of the cases. In this group, 99% of the cases were rated as appropriate, 1% as inappropriate, and fewer than 1% as uncertain. The remaining 29% of PCI procedures occurred in elective cases, of which 50% were rated as appropriate, 12% as inappropriate, and 38% as uncertain, Dr. Chan reported.

The three most common reasons for rating a case as inappropriate included patients with no ischemia, patients with mild ischemia, and asymptomatic patients, he said in an interview.

 

 

To address this issue, the ACC should develop a "real-time decision aid" that encourages interventionalists to "take a step back" during a catheterization to review a patient’s history and make a more informed decision on the need for PCI, Dr. Chan said. The interventional cardiologist should review the degree of symptoms a patient has had and the evidence of ischemia, and take those findings into account when deciding whether the patient needs PCI.

Dr. Chan and Dr. McNulty said they had no disclosures.

Body

The incidence of inappropriate PCIs will never reach zero. There will always be cases that the clinician knows are appropriate but that are impossible to define adequately using the NCDR data forms. There probably are cases in which patients are not properly worked up, but I’m not sure you can consistently evaluate cases adequately using the NCDR database.

We must be careful in what we say about institutions that seem to have "inappropriate" cases. Part of the problem may be the documentation. In my hospital, we found patients who initially seemed inappropriate, but when we looked harder we found that the problem lay in data recording. Rather than judging whether hospitals are doing a good or bad job, the focus should be on helping hospitals do better by helping them improve their patient selection and their case documentation. But hospitals also need to look at which patients are undergoing coronary procedures and defer the ones that are truly inappropriate.

    


Dr. William S. Weintraub

The goal is to help hospitals do a better job. When you give hospitals and physicians performance data they inevitably improve. It happened with our program at Christiana. When I arrived 5 years ago, we first entered the NCDR, and in our first report back we looked terrible. But – no surprise – a lot of the problem turned out to be getting the documentation of cases right, and giving people an opportunity to think carefully about case selection. We use the information we get back from the NCDR to fix what is fixable in our decision making.

It’s possible that data like these from the NCDR will eventually be released to the general public, a step that the Society of Thoracic Surgeons (STS) has already taken for their registry of cardiothoracic surgery programs. The NCDR is under pressure from insurers, public interest groups, the media, and other stakeholders to make its registry data public. It is great that the STS has made its data publicly available. The ACC has followed a lot of what the STS has pioneered, and I think it’s inevitable that the NCDR data will be made public. I don’t like the one- to three-star rating system that the STS uses, but I’m not sure there is any really good way to present the information to the general public.

William S. Weintraub, M.D., is chief of cardiology at Christiana Care Health System in Newark, Del. He serves on the management board of the NCDR, and previously chaired the NCDR’s CathPCI registry. He said that he has received consulting fees or honoraria from Eli Lilly, Sanofi-Aventis, Shinogi, Cardionet, and Bristol-Myers Squibb. He has also received research grants from AstraZeneca, Abbott, BMS, Sanofi-Aventis, and Otsuka.

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Body

The incidence of inappropriate PCIs will never reach zero. There will always be cases that the clinician knows are appropriate but that are impossible to define adequately using the NCDR data forms. There probably are cases in which patients are not properly worked up, but I’m not sure you can consistently evaluate cases adequately using the NCDR database.

We must be careful in what we say about institutions that seem to have "inappropriate" cases. Part of the problem may be the documentation. In my hospital, we found patients who initially seemed inappropriate, but when we looked harder we found that the problem lay in data recording. Rather than judging whether hospitals are doing a good or bad job, the focus should be on helping hospitals do better by helping them improve their patient selection and their case documentation. But hospitals also need to look at which patients are undergoing coronary procedures and defer the ones that are truly inappropriate.

    


Dr. William S. Weintraub

The goal is to help hospitals do a better job. When you give hospitals and physicians performance data they inevitably improve. It happened with our program at Christiana. When I arrived 5 years ago, we first entered the NCDR, and in our first report back we looked terrible. But – no surprise – a lot of the problem turned out to be getting the documentation of cases right, and giving people an opportunity to think carefully about case selection. We use the information we get back from the NCDR to fix what is fixable in our decision making.

It’s possible that data like these from the NCDR will eventually be released to the general public, a step that the Society of Thoracic Surgeons (STS) has already taken for their registry of cardiothoracic surgery programs. The NCDR is under pressure from insurers, public interest groups, the media, and other stakeholders to make its registry data public. It is great that the STS has made its data publicly available. The ACC has followed a lot of what the STS has pioneered, and I think it’s inevitable that the NCDR data will be made public. I don’t like the one- to three-star rating system that the STS uses, but I’m not sure there is any really good way to present the information to the general public.

William S. Weintraub, M.D., is chief of cardiology at Christiana Care Health System in Newark, Del. He serves on the management board of the NCDR, and previously chaired the NCDR’s CathPCI registry. He said that he has received consulting fees or honoraria from Eli Lilly, Sanofi-Aventis, Shinogi, Cardionet, and Bristol-Myers Squibb. He has also received research grants from AstraZeneca, Abbott, BMS, Sanofi-Aventis, and Otsuka.

Body

The incidence of inappropriate PCIs will never reach zero. There will always be cases that the clinician knows are appropriate but that are impossible to define adequately using the NCDR data forms. There probably are cases in which patients are not properly worked up, but I’m not sure you can consistently evaluate cases adequately using the NCDR database.

We must be careful in what we say about institutions that seem to have "inappropriate" cases. Part of the problem may be the documentation. In my hospital, we found patients who initially seemed inappropriate, but when we looked harder we found that the problem lay in data recording. Rather than judging whether hospitals are doing a good or bad job, the focus should be on helping hospitals do better by helping them improve their patient selection and their case documentation. But hospitals also need to look at which patients are undergoing coronary procedures and defer the ones that are truly inappropriate.

    


Dr. William S. Weintraub

The goal is to help hospitals do a better job. When you give hospitals and physicians performance data they inevitably improve. It happened with our program at Christiana. When I arrived 5 years ago, we first entered the NCDR, and in our first report back we looked terrible. But – no surprise – a lot of the problem turned out to be getting the documentation of cases right, and giving people an opportunity to think carefully about case selection. We use the information we get back from the NCDR to fix what is fixable in our decision making.

It’s possible that data like these from the NCDR will eventually be released to the general public, a step that the Society of Thoracic Surgeons (STS) has already taken for their registry of cardiothoracic surgery programs. The NCDR is under pressure from insurers, public interest groups, the media, and other stakeholders to make its registry data public. It is great that the STS has made its data publicly available. The ACC has followed a lot of what the STS has pioneered, and I think it’s inevitable that the NCDR data will be made public. I don’t like the one- to three-star rating system that the STS uses, but I’m not sure there is any really good way to present the information to the general public.

William S. Weintraub, M.D., is chief of cardiology at Christiana Care Health System in Newark, Del. He serves on the management board of the NCDR, and previously chaired the NCDR’s CathPCI registry. He said that he has received consulting fees or honoraria from Eli Lilly, Sanofi-Aventis, Shinogi, Cardionet, and Bristol-Myers Squibb. He has also received research grants from AstraZeneca, Abbott, BMS, Sanofi-Aventis, and Otsuka.

Title
Cutting Inappropriate Cases Requires Better Documentation and Patient Selection
Cutting Inappropriate Cases Requires Better Documentation and Patient Selection

NEW ORLEANS – About 12% of the more than 140,000 Americans who underwent elective coronary artery stenting during 2009-2010 had an inappropriate procedure, based on an analysis of data from a national coronary stent registry maintained by the American College of Cardiology.

In contrast, the rate of inappropriate procedures was 1% in the larger group of more than 355,000 patients who had an acute need for percutaneous coronary interventions (PCI) during the period studied, Dr. Paul S. Chan said at the annual meeting of the American College of Cardiology.

The analysis also showed a striking hospital-to-hospital variation in the rate of elective PCI cases flagged as inappropriate. About 25% of the hospitals doing elective cases had a rate below 6%; another quarter had a rate of 17% or higher. Yet some hospitals had inappropriate rates that exceeded 30%.

Dr. Paul S. Chan    

Starting in May 2011, the ACC will start reporting data from this analysis to each of the more than 1,000 participating U.S. hospitals. By carefully reviewing cases that have been flagged as inappropriate, it is hoped that hospitals will learn from their mistakes and drive down the inappropriate rate, especially for elective PCIs, said Dr. Chan, a cardiologist at the Mid-America Heart Institute of Saint Luke’s Hospital in Kansas City, Mo.

The ACC collects the PCI data through the CathPCI portion of its National Cardiovascular Data Registry (NCDR). Dr. Chan and his associates rated each procedure they reviewed as appropriate, inappropriate, or uncertain based on comprehensive criteria established by an ACC expert panel (J. Am. Coll. Card. 2009;53:530-53).

But even with feedback and review of inappropriate PCIs, the rate of these cases will probably never drop to zero, he said.

Other experts hailed the analysis and feedback program as an advance that will improve U.S. use of PCI, but they also cautioned that the findings must be interpreted carefully.

"About 25% of the interventional cases in my practice would be categorized as inappropriate," commented Dr. Edward J. McNulty, an interventional cardiologist at Kaiser Permanente in San Francisco. "I get most of my patients from surgeons or other interventional cardiologists who feel the patients are too high risk. I do a lot of left main and multivessel PCI. There is no way that I can explain on the NCDR form why I consider these patients appropriate. The NCDR data don’t allow you to appreciate nuances. The criteria tend to penalize physicians who deviate from the average [by performing] complex cases."

Additionally, the way patients’ drug use gets recorded on the day of hospitalization is problematic, as patients may stop a chronically-used drug on the day before entering the hospital and be erroneously recorded as not being on a therapy. Another issue is misclassification of symptoms, such as a patient who perceives ischemic chest pain as shortness of breath.

"I believe that inappropriate PCIs occur, and these results can certainly show signals. But within the ‘inappropriate’ procedures are some cases with mitigating circumstances," Dr. McNulty said in an interview.

"There are cases that you know are appropriate, but you can’t get at them adequately with the [NCDR] data forms," agreed Dr. William S. Weintraub, chief of cardiology at the Christiana Care Health System in Newark, Del. "We need to be very careful about what we say about any institution with inappropriate cases." The analysis results are best used to identify inappropriate cases to hospitals so that hospital staffs can closely study these cases, determine if they were truly inappropriate, and if so, to try to find the problems and fix them, Dr. Weintraub said in an interview.

The ACC expert panel published appropriateness criteria for 198 different clinical scenarios based on six separate clinical elements in February 2009. Dr. Chan and his associates applied the criteria to 500,154 U.S. cases that were treated with PCI during July 2009 through the end of September 2010. The criteria sorted cases into three categories: appropriate, inappropriate, or uncertain. Inappropriate cases were situations where the expected negative consequences of the procedure exceeded the expected benefits.

PCI performed for an acute problem (such as high-risk unstable angina or MI) occurred in 71% of the cases. In this group, 99% of the cases were rated as appropriate, 1% as inappropriate, and fewer than 1% as uncertain. The remaining 29% of PCI procedures occurred in elective cases, of which 50% were rated as appropriate, 12% as inappropriate, and 38% as uncertain, Dr. Chan reported.

The three most common reasons for rating a case as inappropriate included patients with no ischemia, patients with mild ischemia, and asymptomatic patients, he said in an interview.

 

 

To address this issue, the ACC should develop a "real-time decision aid" that encourages interventionalists to "take a step back" during a catheterization to review a patient’s history and make a more informed decision on the need for PCI, Dr. Chan said. The interventional cardiologist should review the degree of symptoms a patient has had and the evidence of ischemia, and take those findings into account when deciding whether the patient needs PCI.

Dr. Chan and Dr. McNulty said they had no disclosures.

NEW ORLEANS – About 12% of the more than 140,000 Americans who underwent elective coronary artery stenting during 2009-2010 had an inappropriate procedure, based on an analysis of data from a national coronary stent registry maintained by the American College of Cardiology.

In contrast, the rate of inappropriate procedures was 1% in the larger group of more than 355,000 patients who had an acute need for percutaneous coronary interventions (PCI) during the period studied, Dr. Paul S. Chan said at the annual meeting of the American College of Cardiology.

The analysis also showed a striking hospital-to-hospital variation in the rate of elective PCI cases flagged as inappropriate. About 25% of the hospitals doing elective cases had a rate below 6%; another quarter had a rate of 17% or higher. Yet some hospitals had inappropriate rates that exceeded 30%.

Dr. Paul S. Chan    

Starting in May 2011, the ACC will start reporting data from this analysis to each of the more than 1,000 participating U.S. hospitals. By carefully reviewing cases that have been flagged as inappropriate, it is hoped that hospitals will learn from their mistakes and drive down the inappropriate rate, especially for elective PCIs, said Dr. Chan, a cardiologist at the Mid-America Heart Institute of Saint Luke’s Hospital in Kansas City, Mo.

The ACC collects the PCI data through the CathPCI portion of its National Cardiovascular Data Registry (NCDR). Dr. Chan and his associates rated each procedure they reviewed as appropriate, inappropriate, or uncertain based on comprehensive criteria established by an ACC expert panel (J. Am. Coll. Card. 2009;53:530-53).

But even with feedback and review of inappropriate PCIs, the rate of these cases will probably never drop to zero, he said.

Other experts hailed the analysis and feedback program as an advance that will improve U.S. use of PCI, but they also cautioned that the findings must be interpreted carefully.

"About 25% of the interventional cases in my practice would be categorized as inappropriate," commented Dr. Edward J. McNulty, an interventional cardiologist at Kaiser Permanente in San Francisco. "I get most of my patients from surgeons or other interventional cardiologists who feel the patients are too high risk. I do a lot of left main and multivessel PCI. There is no way that I can explain on the NCDR form why I consider these patients appropriate. The NCDR data don’t allow you to appreciate nuances. The criteria tend to penalize physicians who deviate from the average [by performing] complex cases."

Additionally, the way patients’ drug use gets recorded on the day of hospitalization is problematic, as patients may stop a chronically-used drug on the day before entering the hospital and be erroneously recorded as not being on a therapy. Another issue is misclassification of symptoms, such as a patient who perceives ischemic chest pain as shortness of breath.

"I believe that inappropriate PCIs occur, and these results can certainly show signals. But within the ‘inappropriate’ procedures are some cases with mitigating circumstances," Dr. McNulty said in an interview.

"There are cases that you know are appropriate, but you can’t get at them adequately with the [NCDR] data forms," agreed Dr. William S. Weintraub, chief of cardiology at the Christiana Care Health System in Newark, Del. "We need to be very careful about what we say about any institution with inappropriate cases." The analysis results are best used to identify inappropriate cases to hospitals so that hospital staffs can closely study these cases, determine if they were truly inappropriate, and if so, to try to find the problems and fix them, Dr. Weintraub said in an interview.

The ACC expert panel published appropriateness criteria for 198 different clinical scenarios based on six separate clinical elements in February 2009. Dr. Chan and his associates applied the criteria to 500,154 U.S. cases that were treated with PCI during July 2009 through the end of September 2010. The criteria sorted cases into three categories: appropriate, inappropriate, or uncertain. Inappropriate cases were situations where the expected negative consequences of the procedure exceeded the expected benefits.

PCI performed for an acute problem (such as high-risk unstable angina or MI) occurred in 71% of the cases. In this group, 99% of the cases were rated as appropriate, 1% as inappropriate, and fewer than 1% as uncertain. The remaining 29% of PCI procedures occurred in elective cases, of which 50% were rated as appropriate, 12% as inappropriate, and 38% as uncertain, Dr. Chan reported.

The three most common reasons for rating a case as inappropriate included patients with no ischemia, patients with mild ischemia, and asymptomatic patients, he said in an interview.

 

 

To address this issue, the ACC should develop a "real-time decision aid" that encourages interventionalists to "take a step back" during a catheterization to review a patient’s history and make a more informed decision on the need for PCI, Dr. Chan said. The interventional cardiologist should review the degree of symptoms a patient has had and the evidence of ischemia, and take those findings into account when deciding whether the patient needs PCI.

Dr. Chan and Dr. McNulty said they had no disclosures.

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Major Finding: Of U.S. patients undergoing elective PCI, 12% of cases occurred inappropriately. Among acute PCI cases, 1% occurred inappropriately.

Data Source: Review of 500,154 PCIs performed at U.S. hospitals during July 2009September 2010 and entered into the ACC’s NCDR.

Disclosures: Dr. Chan and Dr. McNulty said they had no disclosures. Dr. Weintraub said that he has received consulting fees or honoraria from Eli Lilly, Sanofi-Aventis, Shinogi, Cardionet, and Bristol-Myers Squibb. He has also received research grants from AstraZeneca, Abbott, BMS, Sanofi-Aventis, and Otsuka.

Blood Cultures Help Assess Selected Children With Pneumonia

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Blood Cultures Help Assess Selected Children With Pneumonia

PHILADELPHIA – Children who present to the emergency department with mild community-acquired pneumonia probably do not require a routine blood culture, but blood cultures can help in the management of children with moderate to severe pneumonia, based on a review of 291 patients.

"The benefit of blood cultures is likely limited to the patient subgroups who are at increased risk for bacteremia," Maria H. Dugan said at the annual meeting of the Eastern Society for Pediatric Research. In the study population, bacteremia occurred with a significantly higher prevalence in patients with pneumonia complications, especially pulmonary complications, said Ms. Dugan, a researcher at Children’s Hospital of Philadelphia (CHOP).

Maria H. Dugan    

The analysis also showed that in five of the six pneumonia patients in the series identified as having bacteremia, the culture results led to a change in management.

"Even though blood cultures were infrequently positive, the positive results often led to meaningful changes in clinical management," said Dr. Samir S. Shah, a pediatric infectious diseases physician at CHOP and the senior investigator for this study. "Equally important, those children with more severe forms of pneumonia, such as empyema, had fairly high rates of bacteremia, about 13%. We think this is sufficiently high to warrant a blood culture," he said in an interview.

Ms. Dugan and her associates performed this analysis because blood cultures are often obtained from children who present to an emergency department with community-acquired pneumonia, even though blood cultures rarely influence the management of adults with pneumonia. The study tried to assess the impact that culture results have on management in children.

"In studies of adults with pneumonia, investigators have found that blood cultures were uncommonly positive, and that even when blood cultures were positive, physicians seldom did anything different as a result. We found a very different story in children," Dr. Shah said.

The investigators’ review included children aged 0-18 from 35 primary care pediatric practices affiliated with CHOP in Pennsylvania, New Jersey, and Delaware who were seen in the emergency department at CHOP during 2006 or 2007 with a discharge diagnosis of pneumonia. The 877 patients evaluated in the emergency department averaged 4 years old, with 78% aged 5 or younger.

The emergency department staff obtained blood cultures on 291 (34%) of the 877 children with pneumonia. The decision of whether to obtain a culture rested solely with the physicians who cared for each child. "There is no protocol [at CHOP] regarding the decision to obtain blood cultures in children with pneumonia," Dr. Shah explained. "We suspect that blood cultures were more commonly obtained in children with a higher degree of illness severity."

Comparison of the children who underwent culturing and those who did not showed that the cultured children were older, with 38% older than 5 years, compared with 13% in this age range among those who were not cultured. Greater disease severity also appeared to distinguish the children who underwent culturing. The cultured children had a higher prevalence of hypoxia, and more often their records said that they appeared ill at presentation, compared with the children who did not undergo culturing, Dr. Shah said.

Six (2%) of the 291 children tested by culturing had a confirmed positive culture. Three additional cultures initially tested positive, but subsequent study showed contaminations that made these cultures false positives. The six true-positive cultures included four with Streptococcus pneumoniae, one with Staphylococcus aureus, and one with Haemophilus influenzae.

Patients with an infiltrate on their chest x-ray, and patients who eventually required hospitalization did not have a significantly higher prevalence of a positive culture compared with the other children. But the analysis showed a statistically significant higher level of positive cultures among the children who presented with any pneumonia complication (8%), and especially in those with pulmonary complications (13%).

For four (1.4%) children, results from the blood culture led the hospital staff to narrow their antibiotic treatment compared with the initial treatment the children received, and in two cases (0.7%) the culture results led to a broadening of the antibiotic coverage. In one of these patients, the culture results led to both broadening and narrowing of the treatment regimen. Dr. Shah explained that in this case when the culture initially showed positive, the medical staff broadened the child’s antibiotic coverage. Soon after, when they had identified the specific pathogen as S. pneumoniae, the staff narrowed the antibiotic treatment. For the sixth patient, the blood culture results led to no change from the initial, empiric regimen. This patient had responded well to the initial regimen of amoxicillin, and was subsequently found infected by an S. pneumoniae strain sensitive to amoxicillin, so no change occurred, Dr. Shah said.

 

 

Ms. Dugan and Dr. Shah said that they had no relevant financial disclosures.




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PHILADELPHIA – Children who present to the emergency department with mild community-acquired pneumonia probably do not require a routine blood culture, but blood cultures can help in the management of children with moderate to severe pneumonia, based on a review of 291 patients.

"The benefit of blood cultures is likely limited to the patient subgroups who are at increased risk for bacteremia," Maria H. Dugan said at the annual meeting of the Eastern Society for Pediatric Research. In the study population, bacteremia occurred with a significantly higher prevalence in patients with pneumonia complications, especially pulmonary complications, said Ms. Dugan, a researcher at Children’s Hospital of Philadelphia (CHOP).

Maria H. Dugan    

The analysis also showed that in five of the six pneumonia patients in the series identified as having bacteremia, the culture results led to a change in management.

"Even though blood cultures were infrequently positive, the positive results often led to meaningful changes in clinical management," said Dr. Samir S. Shah, a pediatric infectious diseases physician at CHOP and the senior investigator for this study. "Equally important, those children with more severe forms of pneumonia, such as empyema, had fairly high rates of bacteremia, about 13%. We think this is sufficiently high to warrant a blood culture," he said in an interview.

Ms. Dugan and her associates performed this analysis because blood cultures are often obtained from children who present to an emergency department with community-acquired pneumonia, even though blood cultures rarely influence the management of adults with pneumonia. The study tried to assess the impact that culture results have on management in children.

"In studies of adults with pneumonia, investigators have found that blood cultures were uncommonly positive, and that even when blood cultures were positive, physicians seldom did anything different as a result. We found a very different story in children," Dr. Shah said.

The investigators’ review included children aged 0-18 from 35 primary care pediatric practices affiliated with CHOP in Pennsylvania, New Jersey, and Delaware who were seen in the emergency department at CHOP during 2006 or 2007 with a discharge diagnosis of pneumonia. The 877 patients evaluated in the emergency department averaged 4 years old, with 78% aged 5 or younger.

The emergency department staff obtained blood cultures on 291 (34%) of the 877 children with pneumonia. The decision of whether to obtain a culture rested solely with the physicians who cared for each child. "There is no protocol [at CHOP] regarding the decision to obtain blood cultures in children with pneumonia," Dr. Shah explained. "We suspect that blood cultures were more commonly obtained in children with a higher degree of illness severity."

Comparison of the children who underwent culturing and those who did not showed that the cultured children were older, with 38% older than 5 years, compared with 13% in this age range among those who were not cultured. Greater disease severity also appeared to distinguish the children who underwent culturing. The cultured children had a higher prevalence of hypoxia, and more often their records said that they appeared ill at presentation, compared with the children who did not undergo culturing, Dr. Shah said.

Six (2%) of the 291 children tested by culturing had a confirmed positive culture. Three additional cultures initially tested positive, but subsequent study showed contaminations that made these cultures false positives. The six true-positive cultures included four with Streptococcus pneumoniae, one with Staphylococcus aureus, and one with Haemophilus influenzae.

Patients with an infiltrate on their chest x-ray, and patients who eventually required hospitalization did not have a significantly higher prevalence of a positive culture compared with the other children. But the analysis showed a statistically significant higher level of positive cultures among the children who presented with any pneumonia complication (8%), and especially in those with pulmonary complications (13%).

For four (1.4%) children, results from the blood culture led the hospital staff to narrow their antibiotic treatment compared with the initial treatment the children received, and in two cases (0.7%) the culture results led to a broadening of the antibiotic coverage. In one of these patients, the culture results led to both broadening and narrowing of the treatment regimen. Dr. Shah explained that in this case when the culture initially showed positive, the medical staff broadened the child’s antibiotic coverage. Soon after, when they had identified the specific pathogen as S. pneumoniae, the staff narrowed the antibiotic treatment. For the sixth patient, the blood culture results led to no change from the initial, empiric regimen. This patient had responded well to the initial regimen of amoxicillin, and was subsequently found infected by an S. pneumoniae strain sensitive to amoxicillin, so no change occurred, Dr. Shah said.

 

 

Ms. Dugan and Dr. Shah said that they had no relevant financial disclosures.




PHILADELPHIA – Children who present to the emergency department with mild community-acquired pneumonia probably do not require a routine blood culture, but blood cultures can help in the management of children with moderate to severe pneumonia, based on a review of 291 patients.

"The benefit of blood cultures is likely limited to the patient subgroups who are at increased risk for bacteremia," Maria H. Dugan said at the annual meeting of the Eastern Society for Pediatric Research. In the study population, bacteremia occurred with a significantly higher prevalence in patients with pneumonia complications, especially pulmonary complications, said Ms. Dugan, a researcher at Children’s Hospital of Philadelphia (CHOP).

Maria H. Dugan    

The analysis also showed that in five of the six pneumonia patients in the series identified as having bacteremia, the culture results led to a change in management.

"Even though blood cultures were infrequently positive, the positive results often led to meaningful changes in clinical management," said Dr. Samir S. Shah, a pediatric infectious diseases physician at CHOP and the senior investigator for this study. "Equally important, those children with more severe forms of pneumonia, such as empyema, had fairly high rates of bacteremia, about 13%. We think this is sufficiently high to warrant a blood culture," he said in an interview.

Ms. Dugan and her associates performed this analysis because blood cultures are often obtained from children who present to an emergency department with community-acquired pneumonia, even though blood cultures rarely influence the management of adults with pneumonia. The study tried to assess the impact that culture results have on management in children.

"In studies of adults with pneumonia, investigators have found that blood cultures were uncommonly positive, and that even when blood cultures were positive, physicians seldom did anything different as a result. We found a very different story in children," Dr. Shah said.

The investigators’ review included children aged 0-18 from 35 primary care pediatric practices affiliated with CHOP in Pennsylvania, New Jersey, and Delaware who were seen in the emergency department at CHOP during 2006 or 2007 with a discharge diagnosis of pneumonia. The 877 patients evaluated in the emergency department averaged 4 years old, with 78% aged 5 or younger.

The emergency department staff obtained blood cultures on 291 (34%) of the 877 children with pneumonia. The decision of whether to obtain a culture rested solely with the physicians who cared for each child. "There is no protocol [at CHOP] regarding the decision to obtain blood cultures in children with pneumonia," Dr. Shah explained. "We suspect that blood cultures were more commonly obtained in children with a higher degree of illness severity."

Comparison of the children who underwent culturing and those who did not showed that the cultured children were older, with 38% older than 5 years, compared with 13% in this age range among those who were not cultured. Greater disease severity also appeared to distinguish the children who underwent culturing. The cultured children had a higher prevalence of hypoxia, and more often their records said that they appeared ill at presentation, compared with the children who did not undergo culturing, Dr. Shah said.

Six (2%) of the 291 children tested by culturing had a confirmed positive culture. Three additional cultures initially tested positive, but subsequent study showed contaminations that made these cultures false positives. The six true-positive cultures included four with Streptococcus pneumoniae, one with Staphylococcus aureus, and one with Haemophilus influenzae.

Patients with an infiltrate on their chest x-ray, and patients who eventually required hospitalization did not have a significantly higher prevalence of a positive culture compared with the other children. But the analysis showed a statistically significant higher level of positive cultures among the children who presented with any pneumonia complication (8%), and especially in those with pulmonary complications (13%).

For four (1.4%) children, results from the blood culture led the hospital staff to narrow their antibiotic treatment compared with the initial treatment the children received, and in two cases (0.7%) the culture results led to a broadening of the antibiotic coverage. In one of these patients, the culture results led to both broadening and narrowing of the treatment regimen. Dr. Shah explained that in this case when the culture initially showed positive, the medical staff broadened the child’s antibiotic coverage. Soon after, when they had identified the specific pathogen as S. pneumoniae, the staff narrowed the antibiotic treatment. For the sixth patient, the blood culture results led to no change from the initial, empiric regimen. This patient had responded well to the initial regimen of amoxicillin, and was subsequently found infected by an S. pneumoniae strain sensitive to amoxicillin, so no change occurred, Dr. Shah said.

 

 

Ms. Dugan and Dr. Shah said that they had no relevant financial disclosures.




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FROM THE ANNUAL MEETING OF THE EASTERN SOCIETY FOR PEDIATRIC RESEARCH

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Hospitals Vary Widely in Applying Proven STEMI Treatments

Hospitals Need to Step Up Their Quality Improvement Commitment
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Hospitals Vary Widely in Applying Proven STEMI Treatments

Implementation of evidence-based treatments for patients with acute myocardial infarction saves lives, but hospitals show substantial variation in the extent to which they apply these treatments, according to a study of more than 60,000 patients treated at 72 Swedish hospitals during 1996-2007.

During the period studied, Swedish hospitals increasingly used proven treatments for patients presenting with ST-elevation MIs, including increased use of reperfusion therapies, aspirin, clopidogrel, statins, beta-blockers, and ACE inhibitors or angiotensin receptor blockers. Concurrently with increased use of these interventions, the standardized, 1-year mortality of patients dropped from 19% in 1996 to 11% in 2007, Dr. Tomas Jernberg, a cardiologist at Karolinska University Hospital in Stockholm, and his associates reported in an article published online on April 27 (JAMA 2011;305:1677-84).

But in addition to documenting the efficacy of evidence-based therapies for treating acute STEMI, the findings also revealed a wide variation in the application of these therapies by all 72 Swedish hospitals that provide care for patients with acute cardiac diseases.

For example, in 2007, 61% of STEMI patients in Sweden underwent primary percutaneous coronary intervention (PCI), up from 12% in 1996. But in 2007, the 95% confidence interval for hospitals delivering primary PCI was 45%-77%, meaning that 2.5% of the participating Swedish hospitals delivered primary PCI to fewer than 45% of their patients, while the 2.5% of Swedish hospitals that used primary PCI most often delivered it to more than 77% of their STEMI patients.

For several treatments, hospital-to-hospital variation in implementation decreased substantially over the period studied, so that by 2007 most hospitals used the treatment to about the same extent. For example, no hospital prescribed clopidogrel to these patients in 1996 (the drug was approved in Europe in 1998), but its use rose to 82% by 2007. Initially, hospitals showed a wide variability in the introduction of clopidogrel, which peaked in 2002, when a 40% gap separated the top quarter of prescribing hospitals from the bottom quarter. But during 2003-2007, this gap shrank, and by 2007 the difference in prescribing rates between the top and bottom hospital quartiles stood at only 3.4%.

However, variations in the prescribing of ACE inhibitors or ARBs persisted through 2007, "indicating a continuous uncertainty around the indications for these treatments early after ST-elevation MI," the authors wrote. By 2007, about 70% of these patients began receiving an ACE inhibitor or ARB at their hospital discharge, but the percentage varied from as low as 50% at some hospitals to as high as 80% at others.

"Our study demonstrates a large variation in the implementation of new treatments between different hospitals. These large variations, especially regarding coronary angiography during the hospital stay and subsequent dual antiplatelet therapy, were greatest during the start-up of new treatment modalities, likely reflecting differential rates of adoption of new treatments and decreased gradually over time," the authors said. They highlighted this variability and its reduction over time as a key factor in improved patient outcomes.

"Variation in treatment and deviations from guideline recommendations have negative effects on mortality and morbidity. The gradual reduction in variability leading to a high level of guideline adherence might therefore be a key reason for the reduction in mortality" seen during 1996-2007. "Therefore, identification of undue variations in the processes of care and highlighting areas of need for quality improvement programs are important tasks for the quality registries in health care," they concluded.

Dr. Jernberg and his coauthors said that they had no disclosures.

Body

An important finding from the study reported by Dr. Jernberg and his coauthors is the large variation among Swedish hospitals in the implementation of evidence-based and guideline-recommended treatments. Significant evidence exists that U.S. hospitals also have a wide variation in the quality of care they deliver to ST-elevation MI patients, as well as to patients with other disorders. Participation by hospitals in registries that provide timely feedback on patient management may be the best way to deal with these variations and improve the quality of care patients receive globally.

Many explanations exist for why hospitals vary in the extent to which they deliver evidence-based care. The commitment of hospitals and their staffs to delivering optimal care depends on institutional resources, goals, administrative support, physician leadership, having quality measures in place, and having a system for providing feedback on care that’s been delivered.

Although several options are available to hospitals for monitoring the care they deliver and receiving feedback, one system that is especially well suited for the care of patients with STEMI is the National Cardiovascular Data Registry (NCDR) ACTION Registry–Get With the Guidelines program of the American College of Cardiology and the American Heart Association. Participating hospitals get weekly, virtually real-time feedback on their performance, so that they can track how well they treat patients compared with similar hospitals, and so that they receive information on cases where their care fell short quickly enough to perform a meaningful investigation into what happened. This program also provides to participating hospitals, without charge, standardized order software that eliminates the need for physicians to always remember to write prescriptions for each drug that a STEMI patient should receive.

Unfortunately, a large number of U.S. hospitals that care for acute MI patients do not participate in this registry or in any other similar program. According to information provided by the ACC, in April 2011, 557 U.S. hospitals participated in the ACTION Registry-GWTG, less than 25% of the roughly 4,000 U.S. hospitals that provide care to patients with acute MI. Although reasons for lack of participation can differ, in general I think it is due to a lack of leadership in the hospital and a lack of focus on providing the best quality of care to patients. The time may have come to change our systems so that participation in a quality-improvement program is not discretionary. Simply encouraging physicians and hospitals to do the right thing may no longer be enough as we continue to see wide discrepancies in the application of evidence-based interventions and in patient outcomes.

Societies and regulatory agencies that issue treatment guidelines should include in their recommendations that hospitals participate in some type of national or regional registry. Payers can also make such participation part of their pay-for-performance stipulations. Regulatory groups can establish criteria that say that if hospitals fail to comply with registry participation and other quality improvement steps they will face financial penalties, or that steps will be taken so that patients are diverted to other institutions. Participation can also be a criterion for hospital accreditation. In short, we need stricter enforcement to ensure that quality improvement becomes a key part of hospital systems.

If we fail to implement systems that will ensure that we deliver the best, proven care to our patients then we do them a disservice. Hospitals that do not have the leadership, the resources, and the commitment to do this should not be caring for patients. Other hospitals in an area that are willing to do what is necessary to deliver the best care should be the ones that care for patients.

Debabrata Mukherjee, M.D., is professor of medicine and chief of cardiovascular medicine at Texas Tech University in El Paso. His comments are based on an interview and on an accompanying editorial (JAMA 2011:305:1710-11). He said that he has no disclosures.

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Body

An important finding from the study reported by Dr. Jernberg and his coauthors is the large variation among Swedish hospitals in the implementation of evidence-based and guideline-recommended treatments. Significant evidence exists that U.S. hospitals also have a wide variation in the quality of care they deliver to ST-elevation MI patients, as well as to patients with other disorders. Participation by hospitals in registries that provide timely feedback on patient management may be the best way to deal with these variations and improve the quality of care patients receive globally.

Many explanations exist for why hospitals vary in the extent to which they deliver evidence-based care. The commitment of hospitals and their staffs to delivering optimal care depends on institutional resources, goals, administrative support, physician leadership, having quality measures in place, and having a system for providing feedback on care that’s been delivered.

Although several options are available to hospitals for monitoring the care they deliver and receiving feedback, one system that is especially well suited for the care of patients with STEMI is the National Cardiovascular Data Registry (NCDR) ACTION Registry–Get With the Guidelines program of the American College of Cardiology and the American Heart Association. Participating hospitals get weekly, virtually real-time feedback on their performance, so that they can track how well they treat patients compared with similar hospitals, and so that they receive information on cases where their care fell short quickly enough to perform a meaningful investigation into what happened. This program also provides to participating hospitals, without charge, standardized order software that eliminates the need for physicians to always remember to write prescriptions for each drug that a STEMI patient should receive.

Unfortunately, a large number of U.S. hospitals that care for acute MI patients do not participate in this registry or in any other similar program. According to information provided by the ACC, in April 2011, 557 U.S. hospitals participated in the ACTION Registry-GWTG, less than 25% of the roughly 4,000 U.S. hospitals that provide care to patients with acute MI. Although reasons for lack of participation can differ, in general I think it is due to a lack of leadership in the hospital and a lack of focus on providing the best quality of care to patients. The time may have come to change our systems so that participation in a quality-improvement program is not discretionary. Simply encouraging physicians and hospitals to do the right thing may no longer be enough as we continue to see wide discrepancies in the application of evidence-based interventions and in patient outcomes.

Societies and regulatory agencies that issue treatment guidelines should include in their recommendations that hospitals participate in some type of national or regional registry. Payers can also make such participation part of their pay-for-performance stipulations. Regulatory groups can establish criteria that say that if hospitals fail to comply with registry participation and other quality improvement steps they will face financial penalties, or that steps will be taken so that patients are diverted to other institutions. Participation can also be a criterion for hospital accreditation. In short, we need stricter enforcement to ensure that quality improvement becomes a key part of hospital systems.

If we fail to implement systems that will ensure that we deliver the best, proven care to our patients then we do them a disservice. Hospitals that do not have the leadership, the resources, and the commitment to do this should not be caring for patients. Other hospitals in an area that are willing to do what is necessary to deliver the best care should be the ones that care for patients.

Debabrata Mukherjee, M.D., is professor of medicine and chief of cardiovascular medicine at Texas Tech University in El Paso. His comments are based on an interview and on an accompanying editorial (JAMA 2011:305:1710-11). He said that he has no disclosures.

Body

An important finding from the study reported by Dr. Jernberg and his coauthors is the large variation among Swedish hospitals in the implementation of evidence-based and guideline-recommended treatments. Significant evidence exists that U.S. hospitals also have a wide variation in the quality of care they deliver to ST-elevation MI patients, as well as to patients with other disorders. Participation by hospitals in registries that provide timely feedback on patient management may be the best way to deal with these variations and improve the quality of care patients receive globally.

Many explanations exist for why hospitals vary in the extent to which they deliver evidence-based care. The commitment of hospitals and their staffs to delivering optimal care depends on institutional resources, goals, administrative support, physician leadership, having quality measures in place, and having a system for providing feedback on care that’s been delivered.

Although several options are available to hospitals for monitoring the care they deliver and receiving feedback, one system that is especially well suited for the care of patients with STEMI is the National Cardiovascular Data Registry (NCDR) ACTION Registry–Get With the Guidelines program of the American College of Cardiology and the American Heart Association. Participating hospitals get weekly, virtually real-time feedback on their performance, so that they can track how well they treat patients compared with similar hospitals, and so that they receive information on cases where their care fell short quickly enough to perform a meaningful investigation into what happened. This program also provides to participating hospitals, without charge, standardized order software that eliminates the need for physicians to always remember to write prescriptions for each drug that a STEMI patient should receive.

Unfortunately, a large number of U.S. hospitals that care for acute MI patients do not participate in this registry or in any other similar program. According to information provided by the ACC, in April 2011, 557 U.S. hospitals participated in the ACTION Registry-GWTG, less than 25% of the roughly 4,000 U.S. hospitals that provide care to patients with acute MI. Although reasons for lack of participation can differ, in general I think it is due to a lack of leadership in the hospital and a lack of focus on providing the best quality of care to patients. The time may have come to change our systems so that participation in a quality-improvement program is not discretionary. Simply encouraging physicians and hospitals to do the right thing may no longer be enough as we continue to see wide discrepancies in the application of evidence-based interventions and in patient outcomes.

Societies and regulatory agencies that issue treatment guidelines should include in their recommendations that hospitals participate in some type of national or regional registry. Payers can also make such participation part of their pay-for-performance stipulations. Regulatory groups can establish criteria that say that if hospitals fail to comply with registry participation and other quality improvement steps they will face financial penalties, or that steps will be taken so that patients are diverted to other institutions. Participation can also be a criterion for hospital accreditation. In short, we need stricter enforcement to ensure that quality improvement becomes a key part of hospital systems.

If we fail to implement systems that will ensure that we deliver the best, proven care to our patients then we do them a disservice. Hospitals that do not have the leadership, the resources, and the commitment to do this should not be caring for patients. Other hospitals in an area that are willing to do what is necessary to deliver the best care should be the ones that care for patients.

Debabrata Mukherjee, M.D., is professor of medicine and chief of cardiovascular medicine at Texas Tech University in El Paso. His comments are based on an interview and on an accompanying editorial (JAMA 2011:305:1710-11). He said that he has no disclosures.

Title
Hospitals Need to Step Up Their Quality Improvement Commitment
Hospitals Need to Step Up Their Quality Improvement Commitment

Implementation of evidence-based treatments for patients with acute myocardial infarction saves lives, but hospitals show substantial variation in the extent to which they apply these treatments, according to a study of more than 60,000 patients treated at 72 Swedish hospitals during 1996-2007.

During the period studied, Swedish hospitals increasingly used proven treatments for patients presenting with ST-elevation MIs, including increased use of reperfusion therapies, aspirin, clopidogrel, statins, beta-blockers, and ACE inhibitors or angiotensin receptor blockers. Concurrently with increased use of these interventions, the standardized, 1-year mortality of patients dropped from 19% in 1996 to 11% in 2007, Dr. Tomas Jernberg, a cardiologist at Karolinska University Hospital in Stockholm, and his associates reported in an article published online on April 27 (JAMA 2011;305:1677-84).

But in addition to documenting the efficacy of evidence-based therapies for treating acute STEMI, the findings also revealed a wide variation in the application of these therapies by all 72 Swedish hospitals that provide care for patients with acute cardiac diseases.

For example, in 2007, 61% of STEMI patients in Sweden underwent primary percutaneous coronary intervention (PCI), up from 12% in 1996. But in 2007, the 95% confidence interval for hospitals delivering primary PCI was 45%-77%, meaning that 2.5% of the participating Swedish hospitals delivered primary PCI to fewer than 45% of their patients, while the 2.5% of Swedish hospitals that used primary PCI most often delivered it to more than 77% of their STEMI patients.

For several treatments, hospital-to-hospital variation in implementation decreased substantially over the period studied, so that by 2007 most hospitals used the treatment to about the same extent. For example, no hospital prescribed clopidogrel to these patients in 1996 (the drug was approved in Europe in 1998), but its use rose to 82% by 2007. Initially, hospitals showed a wide variability in the introduction of clopidogrel, which peaked in 2002, when a 40% gap separated the top quarter of prescribing hospitals from the bottom quarter. But during 2003-2007, this gap shrank, and by 2007 the difference in prescribing rates between the top and bottom hospital quartiles stood at only 3.4%.

However, variations in the prescribing of ACE inhibitors or ARBs persisted through 2007, "indicating a continuous uncertainty around the indications for these treatments early after ST-elevation MI," the authors wrote. By 2007, about 70% of these patients began receiving an ACE inhibitor or ARB at their hospital discharge, but the percentage varied from as low as 50% at some hospitals to as high as 80% at others.

"Our study demonstrates a large variation in the implementation of new treatments between different hospitals. These large variations, especially regarding coronary angiography during the hospital stay and subsequent dual antiplatelet therapy, were greatest during the start-up of new treatment modalities, likely reflecting differential rates of adoption of new treatments and decreased gradually over time," the authors said. They highlighted this variability and its reduction over time as a key factor in improved patient outcomes.

"Variation in treatment and deviations from guideline recommendations have negative effects on mortality and morbidity. The gradual reduction in variability leading to a high level of guideline adherence might therefore be a key reason for the reduction in mortality" seen during 1996-2007. "Therefore, identification of undue variations in the processes of care and highlighting areas of need for quality improvement programs are important tasks for the quality registries in health care," they concluded.

Dr. Jernberg and his coauthors said that they had no disclosures.

Implementation of evidence-based treatments for patients with acute myocardial infarction saves lives, but hospitals show substantial variation in the extent to which they apply these treatments, according to a study of more than 60,000 patients treated at 72 Swedish hospitals during 1996-2007.

During the period studied, Swedish hospitals increasingly used proven treatments for patients presenting with ST-elevation MIs, including increased use of reperfusion therapies, aspirin, clopidogrel, statins, beta-blockers, and ACE inhibitors or angiotensin receptor blockers. Concurrently with increased use of these interventions, the standardized, 1-year mortality of patients dropped from 19% in 1996 to 11% in 2007, Dr. Tomas Jernberg, a cardiologist at Karolinska University Hospital in Stockholm, and his associates reported in an article published online on April 27 (JAMA 2011;305:1677-84).

But in addition to documenting the efficacy of evidence-based therapies for treating acute STEMI, the findings also revealed a wide variation in the application of these therapies by all 72 Swedish hospitals that provide care for patients with acute cardiac diseases.

For example, in 2007, 61% of STEMI patients in Sweden underwent primary percutaneous coronary intervention (PCI), up from 12% in 1996. But in 2007, the 95% confidence interval for hospitals delivering primary PCI was 45%-77%, meaning that 2.5% of the participating Swedish hospitals delivered primary PCI to fewer than 45% of their patients, while the 2.5% of Swedish hospitals that used primary PCI most often delivered it to more than 77% of their STEMI patients.

For several treatments, hospital-to-hospital variation in implementation decreased substantially over the period studied, so that by 2007 most hospitals used the treatment to about the same extent. For example, no hospital prescribed clopidogrel to these patients in 1996 (the drug was approved in Europe in 1998), but its use rose to 82% by 2007. Initially, hospitals showed a wide variability in the introduction of clopidogrel, which peaked in 2002, when a 40% gap separated the top quarter of prescribing hospitals from the bottom quarter. But during 2003-2007, this gap shrank, and by 2007 the difference in prescribing rates between the top and bottom hospital quartiles stood at only 3.4%.

However, variations in the prescribing of ACE inhibitors or ARBs persisted through 2007, "indicating a continuous uncertainty around the indications for these treatments early after ST-elevation MI," the authors wrote. By 2007, about 70% of these patients began receiving an ACE inhibitor or ARB at their hospital discharge, but the percentage varied from as low as 50% at some hospitals to as high as 80% at others.

"Our study demonstrates a large variation in the implementation of new treatments between different hospitals. These large variations, especially regarding coronary angiography during the hospital stay and subsequent dual antiplatelet therapy, were greatest during the start-up of new treatment modalities, likely reflecting differential rates of adoption of new treatments and decreased gradually over time," the authors said. They highlighted this variability and its reduction over time as a key factor in improved patient outcomes.

"Variation in treatment and deviations from guideline recommendations have negative effects on mortality and morbidity. The gradual reduction in variability leading to a high level of guideline adherence might therefore be a key reason for the reduction in mortality" seen during 1996-2007. "Therefore, identification of undue variations in the processes of care and highlighting areas of need for quality improvement programs are important tasks for the quality registries in health care," they concluded.

Dr. Jernberg and his coauthors said that they had no disclosures.

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Hospitals Vary Widely in Applying Proven STEMI Treatments
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acute myocardial infarction, ST-elevation MIs, reperfusion therapies, aspirin, clopidogrel, statins, beta-blockers, and ACE inhibitors, angiotensin receptor blockers, Dr. Tomas Jernberg, STEMI, primary percutaneous coronary intervention, PCI,
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Major Finding: Patients treated for ST-elevation myocardial infarction at any of 72 Swedish hospitals showed a significant drop in 1-year mortality and in other measures of mortality and morbidity during 1996-2007. Standardized 1-year mortality fell from 19.0 % in 1996 to 11.2% in 2007.

Data Source: Review of 61,238 STEMI patients treated during 1996-2007 at centers participating in a Swedish national registry of hospitals that care for patients with acute cardiac diseases.

Disclosures: Dr. Jernberg and his coauthors said that they had no disclosures.

Hospitals Vary Widely in Applying Proven STEMI Treatments

Hospitals Need to Step Up Their Quality Improvement Commitment
Article Type
Changed
Tue, 07/21/2020 - 13:37
Display Headline
Hospitals Vary Widely in Applying Proven STEMI Treatments

Implementation of evidence-based treatments for patients with acute myocardial infarction saves lives, but hospitals show substantial variation in the extent to which they apply these treatments, according to a study of more than 60,000 patients treated at 72 Swedish hospitals during 1996-2007.

During the period studied, Swedish hospitals increasingly used proven treatments for patients presenting with ST-elevation MIs, including increased use of reperfusion therapies, aspirin, clopidogrel, statins, beta-blockers, and ACE inhibitors or angiotensin receptor blockers. Concurrently with increased use of these interventions, the standardized, 1-year mortality of patients dropped from 19% in 1996 to 11% in 2007, Dr. Tomas Jernberg, a cardiologist at Karolinska University Hospital in Stockholm, and his associates reported in an article published online on April 27 (JAMA 2011;305:1677-84).

But in addition to documenting the efficacy of evidence-based therapies for treating acute STEMI, the findings also revealed a wide variation in the application of these therapies by all 72 Swedish hospitals that provide care for patients with acute cardiac diseases.

For example, in 2007, 61% of STEMI patients in Sweden underwent primary percutaneous coronary intervention (PCI), up from 12% in 1996. But in 2007, the 95% confidence interval for hospitals delivering primary PCI was 45%-77%, meaning that 2.5% of the participating Swedish hospitals delivered primary PCI to fewer than 45% of their patients, while the 2.5% of Swedish hospitals that used primary PCI most often delivered it to more than 77% of their STEMI patients.

For several treatments, hospital-to-hospital variation in implementation decreased substantially over the period studied, so that by 2007 most hospitals used the treatment to about the same extent. For example, no hospital prescribed clopidogrel to these patients in 1996 (the drug was approved in Europe in 1998), but its use rose to 82% by 2007. Initially, hospitals showed a wide variability in the introduction of clopidogrel, which peaked in 2002, when a 40% gap separated the top quarter of prescribing hospitals from the bottom quarter. But during 2003-2007, this gap shrank, and by 2007 the difference in prescribing rates between the top and bottom hospital quartiles stood at only 3.4%.

However, variations in the prescribing of ACE inhibitors or ARBs persisted through 2007, "indicating a continuous uncertainty around the indications for these treatments early after ST-elevation MI," the authors wrote. By 2007, about 70% of these patients began receiving an ACE inhibitor or ARB at their hospital discharge, but the percentage varied from as low as 50% at some hospitals to as high as 80% at others.

"Our study demonstrates a large variation in the implementation of new treatments between different hospitals. These large variations, especially regarding coronary angiography during the hospital stay and subsequent dual antiplatelet therapy, were greatest during the start-up of new treatment modalities, likely reflecting differential rates of adoption of new treatments and decreased gradually over time," the authors said. They highlighted this variability and its reduction over time as a key factor in improved patient outcomes.

"Variation in treatment and deviations from guideline recommendations have negative effects on mortality and morbidity. The gradual reduction in variability leading to a high level of guideline adherence might therefore be a key reason for the reduction in mortality" seen during 1996-2007. "Therefore, identification of undue variations in the processes of care and highlighting areas of need for quality improvement programs are important tasks for the quality registries in health care," they concluded.

Dr. Jernberg and his coauthors said that they had no disclosures.

Body

An important finding from the study reported by Dr. Jernberg and his coauthors is the large variation among Swedish hospitals in the implementation of evidence-based and guideline-recommended treatments. Significant evidence exists that U.S. hospitals also have a wide variation in the quality of care they deliver to ST-elevation MI patients, as well as to patients with other disorders. Participation by hospitals in registries that provide timely feedback on patient management may be the best way to deal with these variations and improve the quality of care patients receive globally.

Many explanations exist for why hospitals vary in the extent to which they deliver evidence-based care. The commitment of hospitals and their staffs to delivering optimal care depends on institutional resources, goals, administrative support, physician leadership, having quality measures in place, and having a system for providing feedback on care that’s been delivered.

Although several options are available to hospitals for monitoring the care they deliver and receiving feedback, one system that is especially well suited for the care of patients with STEMI is the National Cardiovascular Data Registry (NCDR) ACTION Registry–Get With the Guidelines program of the American College of Cardiology and the American Heart Association. Participating hospitals get weekly, virtually real-time feedback on their performance, so that they can track how well they treat patients compared with similar hospitals, and so that they receive information on cases where their care fell short quickly enough to perform a meaningful investigation into what happened. This program also provides to participating hospitals, without charge, standardized order software that eliminates the need for physicians to always remember to write prescriptions for each drug that a STEMI patient should receive.

Unfortunately, a large number of U.S. hospitals that care for acute MI patients do not participate in this registry or in any other similar program. According to information provided by the ACC, in April 2011, 557 U.S. hospitals participated in the ACTION Registry-GWTG, less than 25% of the roughly 4,000 U.S. hospitals that provide care to patients with acute MI. Although reasons for lack of participation can differ, in general I think it is due to a lack of leadership in the hospital and a lack of focus on providing the best quality of care to patients. The time may have come to change our systems so that participation in a quality-improvement program is not discretionary. Simply encouraging physicians and hospitals to do the right thing may no longer be enough as we continue to see wide discrepancies in the application of evidence-based interventions and in patient outcomes.

Societies and regulatory agencies that issue treatment guidelines should include in their recommendations that hospitals participate in some type of national or regional registry. Payers can also make such participation part of their pay-for-performance stipulations. Regulatory groups can establish criteria that say that if hospitals fail to comply with registry participation and other quality improvement steps they will face financial penalties, or that steps will be taken so that patients are diverted to other institutions. Participation can also be a criterion for hospital accreditation. In short, we need stricter enforcement to ensure that quality improvement becomes a key part of hospital systems.

If we fail to implement systems that will ensure that we deliver the best, proven care to our patients then we do them a disservice. Hospitals that do not have the leadership, the resources, and the commitment to do this should not be caring for patients. Other hospitals in an area that are willing to do what is necessary to deliver the best care should be the ones that care for patients.

Debabrata Mukherjee, M.D., is professor of medicine and chief of cardiovascular medicine at Texas Tech University in El Paso. His comments are based on an interview and on an accompanying editorial (JAMA 2011:305:1710-11). He said that he has no disclosures.

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acute myocardial infarction, ST-elevation MIs, reperfusion therapies, aspirin, clopidogrel, statins, beta-blockers, and ACE inhibitors, angiotensin receptor blockers, Dr. Tomas Jernberg, STEMI, primary percutaneous coronary intervention, PCI,
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Body

An important finding from the study reported by Dr. Jernberg and his coauthors is the large variation among Swedish hospitals in the implementation of evidence-based and guideline-recommended treatments. Significant evidence exists that U.S. hospitals also have a wide variation in the quality of care they deliver to ST-elevation MI patients, as well as to patients with other disorders. Participation by hospitals in registries that provide timely feedback on patient management may be the best way to deal with these variations and improve the quality of care patients receive globally.

Many explanations exist for why hospitals vary in the extent to which they deliver evidence-based care. The commitment of hospitals and their staffs to delivering optimal care depends on institutional resources, goals, administrative support, physician leadership, having quality measures in place, and having a system for providing feedback on care that’s been delivered.

Although several options are available to hospitals for monitoring the care they deliver and receiving feedback, one system that is especially well suited for the care of patients with STEMI is the National Cardiovascular Data Registry (NCDR) ACTION Registry–Get With the Guidelines program of the American College of Cardiology and the American Heart Association. Participating hospitals get weekly, virtually real-time feedback on their performance, so that they can track how well they treat patients compared with similar hospitals, and so that they receive information on cases where their care fell short quickly enough to perform a meaningful investigation into what happened. This program also provides to participating hospitals, without charge, standardized order software that eliminates the need for physicians to always remember to write prescriptions for each drug that a STEMI patient should receive.

Unfortunately, a large number of U.S. hospitals that care for acute MI patients do not participate in this registry or in any other similar program. According to information provided by the ACC, in April 2011, 557 U.S. hospitals participated in the ACTION Registry-GWTG, less than 25% of the roughly 4,000 U.S. hospitals that provide care to patients with acute MI. Although reasons for lack of participation can differ, in general I think it is due to a lack of leadership in the hospital and a lack of focus on providing the best quality of care to patients. The time may have come to change our systems so that participation in a quality-improvement program is not discretionary. Simply encouraging physicians and hospitals to do the right thing may no longer be enough as we continue to see wide discrepancies in the application of evidence-based interventions and in patient outcomes.

Societies and regulatory agencies that issue treatment guidelines should include in their recommendations that hospitals participate in some type of national or regional registry. Payers can also make such participation part of their pay-for-performance stipulations. Regulatory groups can establish criteria that say that if hospitals fail to comply with registry participation and other quality improvement steps they will face financial penalties, or that steps will be taken so that patients are diverted to other institutions. Participation can also be a criterion for hospital accreditation. In short, we need stricter enforcement to ensure that quality improvement becomes a key part of hospital systems.

If we fail to implement systems that will ensure that we deliver the best, proven care to our patients then we do them a disservice. Hospitals that do not have the leadership, the resources, and the commitment to do this should not be caring for patients. Other hospitals in an area that are willing to do what is necessary to deliver the best care should be the ones that care for patients.

Debabrata Mukherjee, M.D., is professor of medicine and chief of cardiovascular medicine at Texas Tech University in El Paso. His comments are based on an interview and on an accompanying editorial (JAMA 2011:305:1710-11). He said that he has no disclosures.

Body

An important finding from the study reported by Dr. Jernberg and his coauthors is the large variation among Swedish hospitals in the implementation of evidence-based and guideline-recommended treatments. Significant evidence exists that U.S. hospitals also have a wide variation in the quality of care they deliver to ST-elevation MI patients, as well as to patients with other disorders. Participation by hospitals in registries that provide timely feedback on patient management may be the best way to deal with these variations and improve the quality of care patients receive globally.

Many explanations exist for why hospitals vary in the extent to which they deliver evidence-based care. The commitment of hospitals and their staffs to delivering optimal care depends on institutional resources, goals, administrative support, physician leadership, having quality measures in place, and having a system for providing feedback on care that’s been delivered.

Although several options are available to hospitals for monitoring the care they deliver and receiving feedback, one system that is especially well suited for the care of patients with STEMI is the National Cardiovascular Data Registry (NCDR) ACTION Registry–Get With the Guidelines program of the American College of Cardiology and the American Heart Association. Participating hospitals get weekly, virtually real-time feedback on their performance, so that they can track how well they treat patients compared with similar hospitals, and so that they receive information on cases where their care fell short quickly enough to perform a meaningful investigation into what happened. This program also provides to participating hospitals, without charge, standardized order software that eliminates the need for physicians to always remember to write prescriptions for each drug that a STEMI patient should receive.

Unfortunately, a large number of U.S. hospitals that care for acute MI patients do not participate in this registry or in any other similar program. According to information provided by the ACC, in April 2011, 557 U.S. hospitals participated in the ACTION Registry-GWTG, less than 25% of the roughly 4,000 U.S. hospitals that provide care to patients with acute MI. Although reasons for lack of participation can differ, in general I think it is due to a lack of leadership in the hospital and a lack of focus on providing the best quality of care to patients. The time may have come to change our systems so that participation in a quality-improvement program is not discretionary. Simply encouraging physicians and hospitals to do the right thing may no longer be enough as we continue to see wide discrepancies in the application of evidence-based interventions and in patient outcomes.

Societies and regulatory agencies that issue treatment guidelines should include in their recommendations that hospitals participate in some type of national or regional registry. Payers can also make such participation part of their pay-for-performance stipulations. Regulatory groups can establish criteria that say that if hospitals fail to comply with registry participation and other quality improvement steps they will face financial penalties, or that steps will be taken so that patients are diverted to other institutions. Participation can also be a criterion for hospital accreditation. In short, we need stricter enforcement to ensure that quality improvement becomes a key part of hospital systems.

If we fail to implement systems that will ensure that we deliver the best, proven care to our patients then we do them a disservice. Hospitals that do not have the leadership, the resources, and the commitment to do this should not be caring for patients. Other hospitals in an area that are willing to do what is necessary to deliver the best care should be the ones that care for patients.

Debabrata Mukherjee, M.D., is professor of medicine and chief of cardiovascular medicine at Texas Tech University in El Paso. His comments are based on an interview and on an accompanying editorial (JAMA 2011:305:1710-11). He said that he has no disclosures.

Title
Hospitals Need to Step Up Their Quality Improvement Commitment
Hospitals Need to Step Up Their Quality Improvement Commitment

Implementation of evidence-based treatments for patients with acute myocardial infarction saves lives, but hospitals show substantial variation in the extent to which they apply these treatments, according to a study of more than 60,000 patients treated at 72 Swedish hospitals during 1996-2007.

During the period studied, Swedish hospitals increasingly used proven treatments for patients presenting with ST-elevation MIs, including increased use of reperfusion therapies, aspirin, clopidogrel, statins, beta-blockers, and ACE inhibitors or angiotensin receptor blockers. Concurrently with increased use of these interventions, the standardized, 1-year mortality of patients dropped from 19% in 1996 to 11% in 2007, Dr. Tomas Jernberg, a cardiologist at Karolinska University Hospital in Stockholm, and his associates reported in an article published online on April 27 (JAMA 2011;305:1677-84).

But in addition to documenting the efficacy of evidence-based therapies for treating acute STEMI, the findings also revealed a wide variation in the application of these therapies by all 72 Swedish hospitals that provide care for patients with acute cardiac diseases.

For example, in 2007, 61% of STEMI patients in Sweden underwent primary percutaneous coronary intervention (PCI), up from 12% in 1996. But in 2007, the 95% confidence interval for hospitals delivering primary PCI was 45%-77%, meaning that 2.5% of the participating Swedish hospitals delivered primary PCI to fewer than 45% of their patients, while the 2.5% of Swedish hospitals that used primary PCI most often delivered it to more than 77% of their STEMI patients.

For several treatments, hospital-to-hospital variation in implementation decreased substantially over the period studied, so that by 2007 most hospitals used the treatment to about the same extent. For example, no hospital prescribed clopidogrel to these patients in 1996 (the drug was approved in Europe in 1998), but its use rose to 82% by 2007. Initially, hospitals showed a wide variability in the introduction of clopidogrel, which peaked in 2002, when a 40% gap separated the top quarter of prescribing hospitals from the bottom quarter. But during 2003-2007, this gap shrank, and by 2007 the difference in prescribing rates between the top and bottom hospital quartiles stood at only 3.4%.

However, variations in the prescribing of ACE inhibitors or ARBs persisted through 2007, "indicating a continuous uncertainty around the indications for these treatments early after ST-elevation MI," the authors wrote. By 2007, about 70% of these patients began receiving an ACE inhibitor or ARB at their hospital discharge, but the percentage varied from as low as 50% at some hospitals to as high as 80% at others.

"Our study demonstrates a large variation in the implementation of new treatments between different hospitals. These large variations, especially regarding coronary angiography during the hospital stay and subsequent dual antiplatelet therapy, were greatest during the start-up of new treatment modalities, likely reflecting differential rates of adoption of new treatments and decreased gradually over time," the authors said. They highlighted this variability and its reduction over time as a key factor in improved patient outcomes.

"Variation in treatment and deviations from guideline recommendations have negative effects on mortality and morbidity. The gradual reduction in variability leading to a high level of guideline adherence might therefore be a key reason for the reduction in mortality" seen during 1996-2007. "Therefore, identification of undue variations in the processes of care and highlighting areas of need for quality improvement programs are important tasks for the quality registries in health care," they concluded.

Dr. Jernberg and his coauthors said that they had no disclosures.

Implementation of evidence-based treatments for patients with acute myocardial infarction saves lives, but hospitals show substantial variation in the extent to which they apply these treatments, according to a study of more than 60,000 patients treated at 72 Swedish hospitals during 1996-2007.

During the period studied, Swedish hospitals increasingly used proven treatments for patients presenting with ST-elevation MIs, including increased use of reperfusion therapies, aspirin, clopidogrel, statins, beta-blockers, and ACE inhibitors or angiotensin receptor blockers. Concurrently with increased use of these interventions, the standardized, 1-year mortality of patients dropped from 19% in 1996 to 11% in 2007, Dr. Tomas Jernberg, a cardiologist at Karolinska University Hospital in Stockholm, and his associates reported in an article published online on April 27 (JAMA 2011;305:1677-84).

But in addition to documenting the efficacy of evidence-based therapies for treating acute STEMI, the findings also revealed a wide variation in the application of these therapies by all 72 Swedish hospitals that provide care for patients with acute cardiac diseases.

For example, in 2007, 61% of STEMI patients in Sweden underwent primary percutaneous coronary intervention (PCI), up from 12% in 1996. But in 2007, the 95% confidence interval for hospitals delivering primary PCI was 45%-77%, meaning that 2.5% of the participating Swedish hospitals delivered primary PCI to fewer than 45% of their patients, while the 2.5% of Swedish hospitals that used primary PCI most often delivered it to more than 77% of their STEMI patients.

For several treatments, hospital-to-hospital variation in implementation decreased substantially over the period studied, so that by 2007 most hospitals used the treatment to about the same extent. For example, no hospital prescribed clopidogrel to these patients in 1996 (the drug was approved in Europe in 1998), but its use rose to 82% by 2007. Initially, hospitals showed a wide variability in the introduction of clopidogrel, which peaked in 2002, when a 40% gap separated the top quarter of prescribing hospitals from the bottom quarter. But during 2003-2007, this gap shrank, and by 2007 the difference in prescribing rates between the top and bottom hospital quartiles stood at only 3.4%.

However, variations in the prescribing of ACE inhibitors or ARBs persisted through 2007, "indicating a continuous uncertainty around the indications for these treatments early after ST-elevation MI," the authors wrote. By 2007, about 70% of these patients began receiving an ACE inhibitor or ARB at their hospital discharge, but the percentage varied from as low as 50% at some hospitals to as high as 80% at others.

"Our study demonstrates a large variation in the implementation of new treatments between different hospitals. These large variations, especially regarding coronary angiography during the hospital stay and subsequent dual antiplatelet therapy, were greatest during the start-up of new treatment modalities, likely reflecting differential rates of adoption of new treatments and decreased gradually over time," the authors said. They highlighted this variability and its reduction over time as a key factor in improved patient outcomes.

"Variation in treatment and deviations from guideline recommendations have negative effects on mortality and morbidity. The gradual reduction in variability leading to a high level of guideline adherence might therefore be a key reason for the reduction in mortality" seen during 1996-2007. "Therefore, identification of undue variations in the processes of care and highlighting areas of need for quality improvement programs are important tasks for the quality registries in health care," they concluded.

Dr. Jernberg and his coauthors said that they had no disclosures.

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Hospitals Vary Widely in Applying Proven STEMI Treatments
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Hospitals Vary Widely in Applying Proven STEMI Treatments
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acute myocardial infarction, ST-elevation MIs, reperfusion therapies, aspirin, clopidogrel, statins, beta-blockers, and ACE inhibitors, angiotensin receptor blockers, Dr. Tomas Jernberg, STEMI, primary percutaneous coronary intervention, PCI,
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Hospitals Vary Widely in Applying Proven STEMI Treatments

Hospitals Need to Step Up Their Quality Improvement Commitment
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Hospitals Vary Widely in Applying Proven STEMI Treatments

Implementation of evidence-based treatments for patients with acute myocardial infarction saves lives, but hospitals show substantial variation in the extent to which they apply these treatments, according to a study of more than 60,000 patients treated at 72 Swedish hospitals during 1996-2007.

During the period studied, Swedish hospitals increasingly used proven treatments for patients presenting with ST-elevation MIs, including increased use of reperfusion therapies, aspirin, clopidogrel, statins, beta-blockers, and ACE inhibitors or angiotensin receptor blockers. Concurrently with increased use of these interventions, the standardized, 1-year mortality of patients dropped from 19% in 1996 to 11% in 2007, Dr. Tomas Jernberg, a cardiologist at Karolinska University Hospital in Stockholm, and his associates reported in an article published online on April 27 (JAMA 2011;305:1677-84).

But in addition to documenting the efficacy of evidence-based therapies for treating acute STEMI, the findings also revealed a wide variation in the application of these therapies by all 72 Swedish hospitals that provide care for patients with acute cardiac diseases.

For example, in 2007, 61% of STEMI patients in Sweden underwent primary percutaneous coronary intervention (PCI), up from 12% in 1996. But in 2007, the 95% confidence interval for hospitals delivering primary PCI was 45%-77%, meaning that 2.5% of the participating Swedish hospitals delivered primary PCI to fewer than 45% of their patients, while the 2.5% of Swedish hospitals that used primary PCI most often delivered it to more than 77% of their STEMI patients.

For several treatments, hospital-to-hospital variation in implementation decreased substantially over the period studied, so that by 2007 most hospitals used the treatment to about the same extent. For example, no hospital prescribed clopidogrel to these patients in 1996 (the drug was approved in Europe in 1998), but its use rose to 82% by 2007. Initially, hospitals showed a wide variability in the introduction of clopidogrel, which peaked in 2002, when a 40% gap separated the top quarter of prescribing hospitals from the bottom quarter. But during 2003-2007, this gap shrank, and by 2007 the difference in prescribing rates between the top and bottom hospital quartiles stood at only 3.4%.

However, variations in the prescribing of ACE inhibitors or ARBs persisted through 2007, "indicating a continuous uncertainty around the indications for these treatments early after ST-elevation MI," the authors wrote. By 2007, about 70% of these patients began receiving an ACE inhibitor or ARB at their hospital discharge, but the percentage varied from as low as 50% at some hospitals to as high as 80% at others.

"Our study demonstrates a large variation in the implementation of new treatments between different hospitals. These large variations, especially regarding coronary angiography during the hospital stay and subsequent dual antiplatelet therapy, were greatest during the start-up of new treatment modalities, likely reflecting differential rates of adoption of new treatments and decreased gradually over time," the authors said. They highlighted this variability and its reduction over time as a key factor in improved patient outcomes.

"Variation in treatment and deviations from guideline recommendations have negative effects on mortality and morbidity. The gradual reduction in variability leading to a high level of guideline adherence might therefore be a key reason for the reduction in mortality" seen during 1996-2007. "Therefore, identification of undue variations in the processes of care and highlighting areas of need for quality improvement programs are important tasks for the quality registries in health care," they concluded.

Dr. Jernberg and his coauthors said that they had no disclosures.

Body

An important finding from the study reported by Dr. Jernberg and his coauthors is the large variation among Swedish hospitals in the implementation of evidence-based and guideline-recommended treatments. Significant evidence exists that U.S. hospitals also have a wide variation in the quality of care they deliver to ST-elevation MI patients, as well as to patients with other disorders. Participation by hospitals in registries that provide timely feedback on patient management may be the best way to deal with these variations and improve the quality of care patients receive globally.

Many explanations exist for why hospitals vary in the extent to which they deliver evidence-based care. The commitment of hospitals and their staffs to delivering optimal care depends on institutional resources, goals, administrative support, physician leadership, having quality measures in place, and having a system for providing feedback on care that’s been delivered.

Although several options are available to hospitals for monitoring the care they deliver and receiving feedback, one system that is especially well suited for the care of patients with STEMI is the National Cardiovascular Data Registry (NCDR) ACTION Registry–Get With the Guidelines program of the American College of Cardiology and the American Heart Association. Participating hospitals get weekly, virtually real-time feedback on their performance, so that they can track how well they treat patients compared with similar hospitals, and so that they receive information on cases where their care fell short quickly enough to perform a meaningful investigation into what happened. This program also provides to participating hospitals, without charge, standardized order software that eliminates the need for physicians to always remember to write prescriptions for each drug that a STEMI patient should receive.

Unfortunately, a large number of U.S. hospitals that care for acute MI patients do not participate in this registry or in any other similar program. According to information provided by the ACC, in April 2011, 557 U.S. hospitals participated in the ACTION Registry-GWTG, less than 25% of the roughly 4,000 U.S. hospitals that provide care to patients with acute MI. Although reasons for lack of participation can differ, in general I think it is due to a lack of leadership in the hospital and a lack of focus on providing the best quality of care to patients. The time may have come to change our systems so that participation in a quality-improvement program is not discretionary. Simply encouraging physicians and hospitals to do the right thing may no longer be enough as we continue to see wide discrepancies in the application of evidence-based interventions and in patient outcomes.

Societies and regulatory agencies that issue treatment guidelines should include in their recommendations that hospitals participate in some type of national or regional registry. Payers can also make such participation part of their pay-for-performance stipulations. Regulatory groups can establish criteria that say that if hospitals fail to comply with registry participation and other quality improvement steps they will face financial penalties, or that steps will be taken so that patients are diverted to other institutions. Participation can also be a criterion for hospital accreditation. In short, we need stricter enforcement to ensure that quality improvement becomes a key part of hospital systems.

If we fail to implement systems that will ensure that we deliver the best, proven care to our patients then we do them a disservice. Hospitals that do not have the leadership, the resources, and the commitment to do this should not be caring for patients. Other hospitals in an area that are willing to do what is necessary to deliver the best care should be the ones that care for patients.

Debabrata Mukherjee, M.D., is professor of medicine and chief of cardiovascular medicine at Texas Tech University in El Paso. His comments are based on an interview and on an accompanying editorial (JAMA 2011:305:1710-11). He said that he has no disclosures.

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acute myocardial infarction, ST-elevation MIs, reperfusion therapies, aspirin, clopidogrel, statins, beta-blockers, and ACE inhibitors, angiotensin receptor blockers, Dr. Tomas Jernberg, STEMI, primary percutaneous coronary intervention, PCI,
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Body

An important finding from the study reported by Dr. Jernberg and his coauthors is the large variation among Swedish hospitals in the implementation of evidence-based and guideline-recommended treatments. Significant evidence exists that U.S. hospitals also have a wide variation in the quality of care they deliver to ST-elevation MI patients, as well as to patients with other disorders. Participation by hospitals in registries that provide timely feedback on patient management may be the best way to deal with these variations and improve the quality of care patients receive globally.

Many explanations exist for why hospitals vary in the extent to which they deliver evidence-based care. The commitment of hospitals and their staffs to delivering optimal care depends on institutional resources, goals, administrative support, physician leadership, having quality measures in place, and having a system for providing feedback on care that’s been delivered.

Although several options are available to hospitals for monitoring the care they deliver and receiving feedback, one system that is especially well suited for the care of patients with STEMI is the National Cardiovascular Data Registry (NCDR) ACTION Registry–Get With the Guidelines program of the American College of Cardiology and the American Heart Association. Participating hospitals get weekly, virtually real-time feedback on their performance, so that they can track how well they treat patients compared with similar hospitals, and so that they receive information on cases where their care fell short quickly enough to perform a meaningful investigation into what happened. This program also provides to participating hospitals, without charge, standardized order software that eliminates the need for physicians to always remember to write prescriptions for each drug that a STEMI patient should receive.

Unfortunately, a large number of U.S. hospitals that care for acute MI patients do not participate in this registry or in any other similar program. According to information provided by the ACC, in April 2011, 557 U.S. hospitals participated in the ACTION Registry-GWTG, less than 25% of the roughly 4,000 U.S. hospitals that provide care to patients with acute MI. Although reasons for lack of participation can differ, in general I think it is due to a lack of leadership in the hospital and a lack of focus on providing the best quality of care to patients. The time may have come to change our systems so that participation in a quality-improvement program is not discretionary. Simply encouraging physicians and hospitals to do the right thing may no longer be enough as we continue to see wide discrepancies in the application of evidence-based interventions and in patient outcomes.

Societies and regulatory agencies that issue treatment guidelines should include in their recommendations that hospitals participate in some type of national or regional registry. Payers can also make such participation part of their pay-for-performance stipulations. Regulatory groups can establish criteria that say that if hospitals fail to comply with registry participation and other quality improvement steps they will face financial penalties, or that steps will be taken so that patients are diverted to other institutions. Participation can also be a criterion for hospital accreditation. In short, we need stricter enforcement to ensure that quality improvement becomes a key part of hospital systems.

If we fail to implement systems that will ensure that we deliver the best, proven care to our patients then we do them a disservice. Hospitals that do not have the leadership, the resources, and the commitment to do this should not be caring for patients. Other hospitals in an area that are willing to do what is necessary to deliver the best care should be the ones that care for patients.

Debabrata Mukherjee, M.D., is professor of medicine and chief of cardiovascular medicine at Texas Tech University in El Paso. His comments are based on an interview and on an accompanying editorial (JAMA 2011:305:1710-11). He said that he has no disclosures.

Body

An important finding from the study reported by Dr. Jernberg and his coauthors is the large variation among Swedish hospitals in the implementation of evidence-based and guideline-recommended treatments. Significant evidence exists that U.S. hospitals also have a wide variation in the quality of care they deliver to ST-elevation MI patients, as well as to patients with other disorders. Participation by hospitals in registries that provide timely feedback on patient management may be the best way to deal with these variations and improve the quality of care patients receive globally.

Many explanations exist for why hospitals vary in the extent to which they deliver evidence-based care. The commitment of hospitals and their staffs to delivering optimal care depends on institutional resources, goals, administrative support, physician leadership, having quality measures in place, and having a system for providing feedback on care that’s been delivered.

Although several options are available to hospitals for monitoring the care they deliver and receiving feedback, one system that is especially well suited for the care of patients with STEMI is the National Cardiovascular Data Registry (NCDR) ACTION Registry–Get With the Guidelines program of the American College of Cardiology and the American Heart Association. Participating hospitals get weekly, virtually real-time feedback on their performance, so that they can track how well they treat patients compared with similar hospitals, and so that they receive information on cases where their care fell short quickly enough to perform a meaningful investigation into what happened. This program also provides to participating hospitals, without charge, standardized order software that eliminates the need for physicians to always remember to write prescriptions for each drug that a STEMI patient should receive.

Unfortunately, a large number of U.S. hospitals that care for acute MI patients do not participate in this registry or in any other similar program. According to information provided by the ACC, in April 2011, 557 U.S. hospitals participated in the ACTION Registry-GWTG, less than 25% of the roughly 4,000 U.S. hospitals that provide care to patients with acute MI. Although reasons for lack of participation can differ, in general I think it is due to a lack of leadership in the hospital and a lack of focus on providing the best quality of care to patients. The time may have come to change our systems so that participation in a quality-improvement program is not discretionary. Simply encouraging physicians and hospitals to do the right thing may no longer be enough as we continue to see wide discrepancies in the application of evidence-based interventions and in patient outcomes.

Societies and regulatory agencies that issue treatment guidelines should include in their recommendations that hospitals participate in some type of national or regional registry. Payers can also make such participation part of their pay-for-performance stipulations. Regulatory groups can establish criteria that say that if hospitals fail to comply with registry participation and other quality improvement steps they will face financial penalties, or that steps will be taken so that patients are diverted to other institutions. Participation can also be a criterion for hospital accreditation. In short, we need stricter enforcement to ensure that quality improvement becomes a key part of hospital systems.

If we fail to implement systems that will ensure that we deliver the best, proven care to our patients then we do them a disservice. Hospitals that do not have the leadership, the resources, and the commitment to do this should not be caring for patients. Other hospitals in an area that are willing to do what is necessary to deliver the best care should be the ones that care for patients.

Debabrata Mukherjee, M.D., is professor of medicine and chief of cardiovascular medicine at Texas Tech University in El Paso. His comments are based on an interview and on an accompanying editorial (JAMA 2011:305:1710-11). He said that he has no disclosures.

Title
Hospitals Need to Step Up Their Quality Improvement Commitment
Hospitals Need to Step Up Their Quality Improvement Commitment

Implementation of evidence-based treatments for patients with acute myocardial infarction saves lives, but hospitals show substantial variation in the extent to which they apply these treatments, according to a study of more than 60,000 patients treated at 72 Swedish hospitals during 1996-2007.

During the period studied, Swedish hospitals increasingly used proven treatments for patients presenting with ST-elevation MIs, including increased use of reperfusion therapies, aspirin, clopidogrel, statins, beta-blockers, and ACE inhibitors or angiotensin receptor blockers. Concurrently with increased use of these interventions, the standardized, 1-year mortality of patients dropped from 19% in 1996 to 11% in 2007, Dr. Tomas Jernberg, a cardiologist at Karolinska University Hospital in Stockholm, and his associates reported in an article published online on April 27 (JAMA 2011;305:1677-84).

But in addition to documenting the efficacy of evidence-based therapies for treating acute STEMI, the findings also revealed a wide variation in the application of these therapies by all 72 Swedish hospitals that provide care for patients with acute cardiac diseases.

For example, in 2007, 61% of STEMI patients in Sweden underwent primary percutaneous coronary intervention (PCI), up from 12% in 1996. But in 2007, the 95% confidence interval for hospitals delivering primary PCI was 45%-77%, meaning that 2.5% of the participating Swedish hospitals delivered primary PCI to fewer than 45% of their patients, while the 2.5% of Swedish hospitals that used primary PCI most often delivered it to more than 77% of their STEMI patients.

For several treatments, hospital-to-hospital variation in implementation decreased substantially over the period studied, so that by 2007 most hospitals used the treatment to about the same extent. For example, no hospital prescribed clopidogrel to these patients in 1996 (the drug was approved in Europe in 1998), but its use rose to 82% by 2007. Initially, hospitals showed a wide variability in the introduction of clopidogrel, which peaked in 2002, when a 40% gap separated the top quarter of prescribing hospitals from the bottom quarter. But during 2003-2007, this gap shrank, and by 2007 the difference in prescribing rates between the top and bottom hospital quartiles stood at only 3.4%.

However, variations in the prescribing of ACE inhibitors or ARBs persisted through 2007, "indicating a continuous uncertainty around the indications for these treatments early after ST-elevation MI," the authors wrote. By 2007, about 70% of these patients began receiving an ACE inhibitor or ARB at their hospital discharge, but the percentage varied from as low as 50% at some hospitals to as high as 80% at others.

"Our study demonstrates a large variation in the implementation of new treatments between different hospitals. These large variations, especially regarding coronary angiography during the hospital stay and subsequent dual antiplatelet therapy, were greatest during the start-up of new treatment modalities, likely reflecting differential rates of adoption of new treatments and decreased gradually over time," the authors said. They highlighted this variability and its reduction over time as a key factor in improved patient outcomes.

"Variation in treatment and deviations from guideline recommendations have negative effects on mortality and morbidity. The gradual reduction in variability leading to a high level of guideline adherence might therefore be a key reason for the reduction in mortality" seen during 1996-2007. "Therefore, identification of undue variations in the processes of care and highlighting areas of need for quality improvement programs are important tasks for the quality registries in health care," they concluded.

Dr. Jernberg and his coauthors said that they had no disclosures.

Implementation of evidence-based treatments for patients with acute myocardial infarction saves lives, but hospitals show substantial variation in the extent to which they apply these treatments, according to a study of more than 60,000 patients treated at 72 Swedish hospitals during 1996-2007.

During the period studied, Swedish hospitals increasingly used proven treatments for patients presenting with ST-elevation MIs, including increased use of reperfusion therapies, aspirin, clopidogrel, statins, beta-blockers, and ACE inhibitors or angiotensin receptor blockers. Concurrently with increased use of these interventions, the standardized, 1-year mortality of patients dropped from 19% in 1996 to 11% in 2007, Dr. Tomas Jernberg, a cardiologist at Karolinska University Hospital in Stockholm, and his associates reported in an article published online on April 27 (JAMA 2011;305:1677-84).

But in addition to documenting the efficacy of evidence-based therapies for treating acute STEMI, the findings also revealed a wide variation in the application of these therapies by all 72 Swedish hospitals that provide care for patients with acute cardiac diseases.

For example, in 2007, 61% of STEMI patients in Sweden underwent primary percutaneous coronary intervention (PCI), up from 12% in 1996. But in 2007, the 95% confidence interval for hospitals delivering primary PCI was 45%-77%, meaning that 2.5% of the participating Swedish hospitals delivered primary PCI to fewer than 45% of their patients, while the 2.5% of Swedish hospitals that used primary PCI most often delivered it to more than 77% of their STEMI patients.

For several treatments, hospital-to-hospital variation in implementation decreased substantially over the period studied, so that by 2007 most hospitals used the treatment to about the same extent. For example, no hospital prescribed clopidogrel to these patients in 1996 (the drug was approved in Europe in 1998), but its use rose to 82% by 2007. Initially, hospitals showed a wide variability in the introduction of clopidogrel, which peaked in 2002, when a 40% gap separated the top quarter of prescribing hospitals from the bottom quarter. But during 2003-2007, this gap shrank, and by 2007 the difference in prescribing rates between the top and bottom hospital quartiles stood at only 3.4%.

However, variations in the prescribing of ACE inhibitors or ARBs persisted through 2007, "indicating a continuous uncertainty around the indications for these treatments early after ST-elevation MI," the authors wrote. By 2007, about 70% of these patients began receiving an ACE inhibitor or ARB at their hospital discharge, but the percentage varied from as low as 50% at some hospitals to as high as 80% at others.

"Our study demonstrates a large variation in the implementation of new treatments between different hospitals. These large variations, especially regarding coronary angiography during the hospital stay and subsequent dual antiplatelet therapy, were greatest during the start-up of new treatment modalities, likely reflecting differential rates of adoption of new treatments and decreased gradually over time," the authors said. They highlighted this variability and its reduction over time as a key factor in improved patient outcomes.

"Variation in treatment and deviations from guideline recommendations have negative effects on mortality and morbidity. The gradual reduction in variability leading to a high level of guideline adherence might therefore be a key reason for the reduction in mortality" seen during 1996-2007. "Therefore, identification of undue variations in the processes of care and highlighting areas of need for quality improvement programs are important tasks for the quality registries in health care," they concluded.

Dr. Jernberg and his coauthors said that they had no disclosures.

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Major Finding: Patients treated for ST-elevation myocardial infarction at any of 72 Swedish hospitals showed a significant drop in 1-year mortality and in other measures of mortality and morbidity during 1996-2007. Standardized 1-year mortality fell from 19.0 % in 1996 to 11.2% in 2007.

Data Source: Review of 61,238 STEMI patients treated during 1996-2007 at centers participating in a Swedish national registry of hospitals that care for patients with acute cardiac diseases.

Disclosures: Dr. Jernberg and his coauthors said that they had no disclosures.

Psoriasis Linked With 6% Higher Cardiovascular Disease Risk

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Psoriasis Linked With 6% Higher Cardiovascular Disease Risk

NEW ORLEANS – Patients with severe psoriasis face a 6% higher 10-year risk for a cardiovascular event than do comparable people without psoriasis, according to the findings of a prospective cohort study of nearly 18,000 people.

This added cardiovascular risk can have substantial implications, as it can move psoriasis patients into a higher Framingham Risk Score category and shift the way physicians need to think about cardiovascular risk management of these patients, Dr. Nehal N. Mehta said at the annual meeting of the American College of Cardiology.

In his practice that focuses on adults with psoriasis, the average background Framingham Risk Score based on low density lipoprotein cholesterol is a 7% 10-year risk for having a cardiovascular event, a level defined as low risk. However, adding the 6% additional risk linked with their psoriasis results in many patients having a 10-year risk of 13% or higher, placing them in the intermediate risk category (generally defined as a 10%-20% risk of having a cardiovascular event).

Patients at that intermediate risk category usually have more stringent targets for lipid levels, blood pressure, and weight although, in this context, it's unclear whether patients who leap into a higher cardiovascular risk level because of their psoriasis require more aggressive medical management; cardiovascular risk management guidelines have yet to elucidate optimal management for this patient subgroup.

Dr. Mehta deals with this dilemma by implementing aggressive lifestyle interventions for these patients, and also by suggesting naturally occurring risk-reduction interventions, such as the consumption of fiber, red yeast rice, soy, phytoestrogens, fish oil, and niacin.

If, after all these interventions, a patient's low density lipoprotein cholesterol or blood pressure remains at a questionably high level, he discusses the option of starting treatment with a statin or an antihypertensive medication, making clear that these steps have not yet been endorsed by most society management guidelines.

"Ultimately, about 5% of my psoriasis patients end up on a statin," said Dr. Mehta, a cardiologist and director of the inflammatory risk clinic in preventive cardiology at the University of Pennsylvania, Philadelphia.

Dr. Mehta and his associates derived an estimate of cardiovascular disease risk attributable to psoriasis by reviewing follow-up data maintained on 3,603 patients with severe psoriasis and 14,330 control participants without psoriasis enrolled in the General Practice Research Database, a collection of records from more than 5 million people seen by U.K. general practice physicians.

The researchers identified cases of severe psoriasis based on their receiving systemic therapy or phototherapy and excluded people with a prior history of cardiovascular events. The average age of all the people in the analysis was about 50 years and, on average, people were followed for about 3 years.

In a multivariable analysis that controlled for diabetes, hypertension, hyperlipidemia, age, gender, body mass index, and smoking status, the risk for a myocardial infarction, stroke, or death from a cardiovascular cause was 53% higher among the psoriasis patients, compared with the controls, a statistically significant difference. This higher cardiovascular risk among patients with psoriasis matched the 50% increased risk proposed last year for patients with rheumatoid arthritis and other forms of inflammatory arthritis including psoriatic arthritis, according to a panel convened by the European League Against Rheumatism (Ann. Rheum. Dis. 2010;69:325-31).

To translate the 1.53 relative risk into an attributable risk, Dr. Mehta and his associates multiplied that factor against the background cardiovascular risk for someone in the general population of the study to derive an adjusted risk. They then subtracted the background risk from the adjusted risk. Over a 10-year period, this translated into an excess risk for a cardiovascular event of 6.2%.

To illustrate the potential impact of this estimate, the researchers then applied this to a consecutive sample of 103 psoriasis patients seen in Dr. Mehta's psoriasis clinic at the Penn Heart and Vascular Center, including nine patients with psoriatic arthritis.

The baseline risk for these men and women averaged 7.3%, a low-risk level, but with the additional 6.2% risk added their functional risk jumped to an average of 13.5%, or to the intermediate-risk level. For individual patients, this signaled a substantial shift in their Framingham Risk Score risk level. Dr. Mehta conceded that the risk adjustment he applied derived from patients with severe psoriasis, while only 10% of patients in his practice have severe disease. About 60% have mild psoriasis, and about 30% have moderately severe disease, he said.

"This is the best we can do" for the time being, he said. "We applied the severe psoriasis metric to everyone to get a hazard estimate. We believe this is better than just multiplying" to recalculate a person's risk, the approach suggested by the EULAR committee.

 

 

He hopes that a larger, prospective study he has begun in collaboration with Dr. Joel M. Gelfand, a dermatologist at the University of Pennsylvania and the senior investigator for this work, will eventually provide a more nuanced risk adjustment for all levels of psoriasis severity. But he said that the current estimate of the increased risk will help persuade psoriasis patients to adopt healthier lifestyles. Patients with psoriasis, at all severity levels, tend to have relatively high rates of obesity, smoking, diabetes, hypertension, and inactivity.

Dr. Mehta added that better medical control of psoriasis also might help blunt the increased cardiovascular risk.

"Psoriasis and atherosclerosis are both T-cell mediated diseases," he observed. Most likely what goes on in the skin -to form the psoriasis plaques - also is going on inside patients' blood vessels, he said.

Dr. Mehta said that he had no disclosures. 

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NEW ORLEANS – Patients with severe psoriasis face a 6% higher 10-year risk for a cardiovascular event than do comparable people without psoriasis, according to the findings of a prospective cohort study of nearly 18,000 people.

This added cardiovascular risk can have substantial implications, as it can move psoriasis patients into a higher Framingham Risk Score category and shift the way physicians need to think about cardiovascular risk management of these patients, Dr. Nehal N. Mehta said at the annual meeting of the American College of Cardiology.

In his practice that focuses on adults with psoriasis, the average background Framingham Risk Score based on low density lipoprotein cholesterol is a 7% 10-year risk for having a cardiovascular event, a level defined as low risk. However, adding the 6% additional risk linked with their psoriasis results in many patients having a 10-year risk of 13% or higher, placing them in the intermediate risk category (generally defined as a 10%-20% risk of having a cardiovascular event).

Patients at that intermediate risk category usually have more stringent targets for lipid levels, blood pressure, and weight although, in this context, it's unclear whether patients who leap into a higher cardiovascular risk level because of their psoriasis require more aggressive medical management; cardiovascular risk management guidelines have yet to elucidate optimal management for this patient subgroup.

Dr. Mehta deals with this dilemma by implementing aggressive lifestyle interventions for these patients, and also by suggesting naturally occurring risk-reduction interventions, such as the consumption of fiber, red yeast rice, soy, phytoestrogens, fish oil, and niacin.

If, after all these interventions, a patient's low density lipoprotein cholesterol or blood pressure remains at a questionably high level, he discusses the option of starting treatment with a statin or an antihypertensive medication, making clear that these steps have not yet been endorsed by most society management guidelines.

"Ultimately, about 5% of my psoriasis patients end up on a statin," said Dr. Mehta, a cardiologist and director of the inflammatory risk clinic in preventive cardiology at the University of Pennsylvania, Philadelphia.

Dr. Mehta and his associates derived an estimate of cardiovascular disease risk attributable to psoriasis by reviewing follow-up data maintained on 3,603 patients with severe psoriasis and 14,330 control participants without psoriasis enrolled in the General Practice Research Database, a collection of records from more than 5 million people seen by U.K. general practice physicians.

The researchers identified cases of severe psoriasis based on their receiving systemic therapy or phototherapy and excluded people with a prior history of cardiovascular events. The average age of all the people in the analysis was about 50 years and, on average, people were followed for about 3 years.

In a multivariable analysis that controlled for diabetes, hypertension, hyperlipidemia, age, gender, body mass index, and smoking status, the risk for a myocardial infarction, stroke, or death from a cardiovascular cause was 53% higher among the psoriasis patients, compared with the controls, a statistically significant difference. This higher cardiovascular risk among patients with psoriasis matched the 50% increased risk proposed last year for patients with rheumatoid arthritis and other forms of inflammatory arthritis including psoriatic arthritis, according to a panel convened by the European League Against Rheumatism (Ann. Rheum. Dis. 2010;69:325-31).

To translate the 1.53 relative risk into an attributable risk, Dr. Mehta and his associates multiplied that factor against the background cardiovascular risk for someone in the general population of the study to derive an adjusted risk. They then subtracted the background risk from the adjusted risk. Over a 10-year period, this translated into an excess risk for a cardiovascular event of 6.2%.

To illustrate the potential impact of this estimate, the researchers then applied this to a consecutive sample of 103 psoriasis patients seen in Dr. Mehta's psoriasis clinic at the Penn Heart and Vascular Center, including nine patients with psoriatic arthritis.

The baseline risk for these men and women averaged 7.3%, a low-risk level, but with the additional 6.2% risk added their functional risk jumped to an average of 13.5%, or to the intermediate-risk level. For individual patients, this signaled a substantial shift in their Framingham Risk Score risk level. Dr. Mehta conceded that the risk adjustment he applied derived from patients with severe psoriasis, while only 10% of patients in his practice have severe disease. About 60% have mild psoriasis, and about 30% have moderately severe disease, he said.

"This is the best we can do" for the time being, he said. "We applied the severe psoriasis metric to everyone to get a hazard estimate. We believe this is better than just multiplying" to recalculate a person's risk, the approach suggested by the EULAR committee.

 

 

He hopes that a larger, prospective study he has begun in collaboration with Dr. Joel M. Gelfand, a dermatologist at the University of Pennsylvania and the senior investigator for this work, will eventually provide a more nuanced risk adjustment for all levels of psoriasis severity. But he said that the current estimate of the increased risk will help persuade psoriasis patients to adopt healthier lifestyles. Patients with psoriasis, at all severity levels, tend to have relatively high rates of obesity, smoking, diabetes, hypertension, and inactivity.

Dr. Mehta added that better medical control of psoriasis also might help blunt the increased cardiovascular risk.

"Psoriasis and atherosclerosis are both T-cell mediated diseases," he observed. Most likely what goes on in the skin -to form the psoriasis plaques - also is going on inside patients' blood vessels, he said.

Dr. Mehta said that he had no disclosures. 

NEW ORLEANS – Patients with severe psoriasis face a 6% higher 10-year risk for a cardiovascular event than do comparable people without psoriasis, according to the findings of a prospective cohort study of nearly 18,000 people.

This added cardiovascular risk can have substantial implications, as it can move psoriasis patients into a higher Framingham Risk Score category and shift the way physicians need to think about cardiovascular risk management of these patients, Dr. Nehal N. Mehta said at the annual meeting of the American College of Cardiology.

In his practice that focuses on adults with psoriasis, the average background Framingham Risk Score based on low density lipoprotein cholesterol is a 7% 10-year risk for having a cardiovascular event, a level defined as low risk. However, adding the 6% additional risk linked with their psoriasis results in many patients having a 10-year risk of 13% or higher, placing them in the intermediate risk category (generally defined as a 10%-20% risk of having a cardiovascular event).

Patients at that intermediate risk category usually have more stringent targets for lipid levels, blood pressure, and weight although, in this context, it's unclear whether patients who leap into a higher cardiovascular risk level because of their psoriasis require more aggressive medical management; cardiovascular risk management guidelines have yet to elucidate optimal management for this patient subgroup.

Dr. Mehta deals with this dilemma by implementing aggressive lifestyle interventions for these patients, and also by suggesting naturally occurring risk-reduction interventions, such as the consumption of fiber, red yeast rice, soy, phytoestrogens, fish oil, and niacin.

If, after all these interventions, a patient's low density lipoprotein cholesterol or blood pressure remains at a questionably high level, he discusses the option of starting treatment with a statin or an antihypertensive medication, making clear that these steps have not yet been endorsed by most society management guidelines.

"Ultimately, about 5% of my psoriasis patients end up on a statin," said Dr. Mehta, a cardiologist and director of the inflammatory risk clinic in preventive cardiology at the University of Pennsylvania, Philadelphia.

Dr. Mehta and his associates derived an estimate of cardiovascular disease risk attributable to psoriasis by reviewing follow-up data maintained on 3,603 patients with severe psoriasis and 14,330 control participants without psoriasis enrolled in the General Practice Research Database, a collection of records from more than 5 million people seen by U.K. general practice physicians.

The researchers identified cases of severe psoriasis based on their receiving systemic therapy or phototherapy and excluded people with a prior history of cardiovascular events. The average age of all the people in the analysis was about 50 years and, on average, people were followed for about 3 years.

In a multivariable analysis that controlled for diabetes, hypertension, hyperlipidemia, age, gender, body mass index, and smoking status, the risk for a myocardial infarction, stroke, or death from a cardiovascular cause was 53% higher among the psoriasis patients, compared with the controls, a statistically significant difference. This higher cardiovascular risk among patients with psoriasis matched the 50% increased risk proposed last year for patients with rheumatoid arthritis and other forms of inflammatory arthritis including psoriatic arthritis, according to a panel convened by the European League Against Rheumatism (Ann. Rheum. Dis. 2010;69:325-31).

To translate the 1.53 relative risk into an attributable risk, Dr. Mehta and his associates multiplied that factor against the background cardiovascular risk for someone in the general population of the study to derive an adjusted risk. They then subtracted the background risk from the adjusted risk. Over a 10-year period, this translated into an excess risk for a cardiovascular event of 6.2%.

To illustrate the potential impact of this estimate, the researchers then applied this to a consecutive sample of 103 psoriasis patients seen in Dr. Mehta's psoriasis clinic at the Penn Heart and Vascular Center, including nine patients with psoriatic arthritis.

The baseline risk for these men and women averaged 7.3%, a low-risk level, but with the additional 6.2% risk added their functional risk jumped to an average of 13.5%, or to the intermediate-risk level. For individual patients, this signaled a substantial shift in their Framingham Risk Score risk level. Dr. Mehta conceded that the risk adjustment he applied derived from patients with severe psoriasis, while only 10% of patients in his practice have severe disease. About 60% have mild psoriasis, and about 30% have moderately severe disease, he said.

"This is the best we can do" for the time being, he said. "We applied the severe psoriasis metric to everyone to get a hazard estimate. We believe this is better than just multiplying" to recalculate a person's risk, the approach suggested by the EULAR committee.

 

 

He hopes that a larger, prospective study he has begun in collaboration with Dr. Joel M. Gelfand, a dermatologist at the University of Pennsylvania and the senior investigator for this work, will eventually provide a more nuanced risk adjustment for all levels of psoriasis severity. But he said that the current estimate of the increased risk will help persuade psoriasis patients to adopt healthier lifestyles. Patients with psoriasis, at all severity levels, tend to have relatively high rates of obesity, smoking, diabetes, hypertension, and inactivity.

Dr. Mehta added that better medical control of psoriasis also might help blunt the increased cardiovascular risk.

"Psoriasis and atherosclerosis are both T-cell mediated diseases," he observed. Most likely what goes on in the skin -to form the psoriasis plaques - also is going on inside patients' blood vessels, he said.

Dr. Mehta said that he had no disclosures. 

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FROM THE ANNUAL MEETING OF THE AMERICAN COLLEGE OF CARDIOLOGY

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Major Finding: Patients with severe psoriasis have a 6% increased 10-year risk for cardiovascular disease events, compared with similar people without psoriasis.

Data Source: A prospective cohort study of 3,603 patients with severe psoriasis and 14,330 matched people without psoriasis followed for an average of 3 years in the General Practice Research Database.

Disclosures: Dr. Mehta said that he had no disclosures.

ED Prescription Failed to Jump-Start Inhaled Steroid for Asthmatic Kids

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PHILADELPHIA – Having emergency physicians start children with persistent asthma on a prescription of an inhaled corticosteroid failed to have a significant impact on the rate at which the families filled a second, follow-up prescription for the same drug from their primary care pediatrician, according to a controlled study with 153 children.

But the study results did show, for the first time in a controlled study of children, that intervention with an inhaled corticosteroid can significantly improve asthma symptoms over the short term, Dr. Esther M. Sampayo said at the annual meeting of the Eastern Society for Pediatric Research.

Dr. Esther M. Sampayo    

"National guidelines have recommended that emergency physicians consider initiating control medications [for children with asthma] in the emergency department," she said. When children don’t receive such a prescription, it’s "a missed opportunity for children who are high emergency department utilizers," said Dr. Sampayo, a pediatric emergency physician at Children’s Hospital of Philadelphia.

"We found that at 2 months [after the index emergency department visit], fewer than 20% of children actually filled a second prescription for their control medication," with similar rates in both the control and intervention groups of the study. This level of failure occurred even though when each child received the initial prescription, the researchers told the family to fill a follow-up prescription from the child’s primary care pediatrician, each pediatrician received an alert to write the second prescription, and virtually all the families had public or private insurance that covered the drug’s cost.

"We’re now testing a new intervention, sending parents a text message to remind them to refill their child’s prescription," Dr. Sampayo said in an interview.

The findings also highlighted the important role that emergency physicians can play in starting children on an inhaled corticosteroid. In prior studies, researchers asked emergency physicians why they generally did not start children with poorly controlled asthma on control medication. The physicians said that they didn’t view it as their appropriate role, and that this task was best reserved for primary care physicians. "All the pediatricians in our study said that the emergency department physicians should write the prescription. They want the emergency physician to do it," she said.

The study enrolled children seen in the emergency department of Children’s Hospital of Philadelphia with an average age of 5 years (range, 1-18 years) during 2006-2009. After randomization, the families of 74 children received a starter prescription for a 30-day supply of an inhaled corticosteroid, either budesonide for children aged 4 or younger, or fluticasone for those aged 5 or older, as well as educational materials and other standard discharge medications for asthma. The 78 control families received the same educational materials and discharge medications but no prescription for a corticosteroid.

By 8 weeks after the emergency department visit, about 63% of the intervention families had filled their initial corticosteroid prescription, compared with about 27% of the control families, a statistically significant difference. But the rate at which the intervention families filled the second prescription – the one they had to get from the child’s primary care pediatrician – dropped to roughly 20% of the intervention families, no different from the 18% rate among the control families. The researchers have not yet examined whether the breakdown in follow-up prescriptions occurred at the level of the primary care pediatrician or in the family’s failure to fill a second prescription that they received.

The follow-up data also showed that while on the initial course of an inhaled steroid, the children had, on average, a significant 2-day drop in the number of days they coughed while asleep, and a significant halving of the number of days when they experienced shortness of breath.

In addition, the first course of an inhaled corticosteroid led to a significant reduction in the use of albuterol as a rescue medication. Children in the intervention group had a 43% rate of never using albuterol or using it less than twice during follow-up, compared with 21% having this usage rate among the control children. At the other end of the spectrum, children in the intervention group had a 44% rate of using albuterol either daily or every other day during follow-up, compared with a 65% rate of such heavy use by the control children.

Dr. Sampayo said that she and her associates had no relevant financial disclosures.

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PHILADELPHIA – Having emergency physicians start children with persistent asthma on a prescription of an inhaled corticosteroid failed to have a significant impact on the rate at which the families filled a second, follow-up prescription for the same drug from their primary care pediatrician, according to a controlled study with 153 children.

But the study results did show, for the first time in a controlled study of children, that intervention with an inhaled corticosteroid can significantly improve asthma symptoms over the short term, Dr. Esther M. Sampayo said at the annual meeting of the Eastern Society for Pediatric Research.

Dr. Esther M. Sampayo    

"National guidelines have recommended that emergency physicians consider initiating control medications [for children with asthma] in the emergency department," she said. When children don’t receive such a prescription, it’s "a missed opportunity for children who are high emergency department utilizers," said Dr. Sampayo, a pediatric emergency physician at Children’s Hospital of Philadelphia.

"We found that at 2 months [after the index emergency department visit], fewer than 20% of children actually filled a second prescription for their control medication," with similar rates in both the control and intervention groups of the study. This level of failure occurred even though when each child received the initial prescription, the researchers told the family to fill a follow-up prescription from the child’s primary care pediatrician, each pediatrician received an alert to write the second prescription, and virtually all the families had public or private insurance that covered the drug’s cost.

"We’re now testing a new intervention, sending parents a text message to remind them to refill their child’s prescription," Dr. Sampayo said in an interview.

The findings also highlighted the important role that emergency physicians can play in starting children on an inhaled corticosteroid. In prior studies, researchers asked emergency physicians why they generally did not start children with poorly controlled asthma on control medication. The physicians said that they didn’t view it as their appropriate role, and that this task was best reserved for primary care physicians. "All the pediatricians in our study said that the emergency department physicians should write the prescription. They want the emergency physician to do it," she said.

The study enrolled children seen in the emergency department of Children’s Hospital of Philadelphia with an average age of 5 years (range, 1-18 years) during 2006-2009. After randomization, the families of 74 children received a starter prescription for a 30-day supply of an inhaled corticosteroid, either budesonide for children aged 4 or younger, or fluticasone for those aged 5 or older, as well as educational materials and other standard discharge medications for asthma. The 78 control families received the same educational materials and discharge medications but no prescription for a corticosteroid.

By 8 weeks after the emergency department visit, about 63% of the intervention families had filled their initial corticosteroid prescription, compared with about 27% of the control families, a statistically significant difference. But the rate at which the intervention families filled the second prescription – the one they had to get from the child’s primary care pediatrician – dropped to roughly 20% of the intervention families, no different from the 18% rate among the control families. The researchers have not yet examined whether the breakdown in follow-up prescriptions occurred at the level of the primary care pediatrician or in the family’s failure to fill a second prescription that they received.

The follow-up data also showed that while on the initial course of an inhaled steroid, the children had, on average, a significant 2-day drop in the number of days they coughed while asleep, and a significant halving of the number of days when they experienced shortness of breath.

In addition, the first course of an inhaled corticosteroid led to a significant reduction in the use of albuterol as a rescue medication. Children in the intervention group had a 43% rate of never using albuterol or using it less than twice during follow-up, compared with 21% having this usage rate among the control children. At the other end of the spectrum, children in the intervention group had a 44% rate of using albuterol either daily or every other day during follow-up, compared with a 65% rate of such heavy use by the control children.

Dr. Sampayo said that she and her associates had no relevant financial disclosures.

PHILADELPHIA – Having emergency physicians start children with persistent asthma on a prescription of an inhaled corticosteroid failed to have a significant impact on the rate at which the families filled a second, follow-up prescription for the same drug from their primary care pediatrician, according to a controlled study with 153 children.

But the study results did show, for the first time in a controlled study of children, that intervention with an inhaled corticosteroid can significantly improve asthma symptoms over the short term, Dr. Esther M. Sampayo said at the annual meeting of the Eastern Society for Pediatric Research.

Dr. Esther M. Sampayo    

"National guidelines have recommended that emergency physicians consider initiating control medications [for children with asthma] in the emergency department," she said. When children don’t receive such a prescription, it’s "a missed opportunity for children who are high emergency department utilizers," said Dr. Sampayo, a pediatric emergency physician at Children’s Hospital of Philadelphia.

"We found that at 2 months [after the index emergency department visit], fewer than 20% of children actually filled a second prescription for their control medication," with similar rates in both the control and intervention groups of the study. This level of failure occurred even though when each child received the initial prescription, the researchers told the family to fill a follow-up prescription from the child’s primary care pediatrician, each pediatrician received an alert to write the second prescription, and virtually all the families had public or private insurance that covered the drug’s cost.

"We’re now testing a new intervention, sending parents a text message to remind them to refill their child’s prescription," Dr. Sampayo said in an interview.

The findings also highlighted the important role that emergency physicians can play in starting children on an inhaled corticosteroid. In prior studies, researchers asked emergency physicians why they generally did not start children with poorly controlled asthma on control medication. The physicians said that they didn’t view it as their appropriate role, and that this task was best reserved for primary care physicians. "All the pediatricians in our study said that the emergency department physicians should write the prescription. They want the emergency physician to do it," she said.

The study enrolled children seen in the emergency department of Children’s Hospital of Philadelphia with an average age of 5 years (range, 1-18 years) during 2006-2009. After randomization, the families of 74 children received a starter prescription for a 30-day supply of an inhaled corticosteroid, either budesonide for children aged 4 or younger, or fluticasone for those aged 5 or older, as well as educational materials and other standard discharge medications for asthma. The 78 control families received the same educational materials and discharge medications but no prescription for a corticosteroid.

By 8 weeks after the emergency department visit, about 63% of the intervention families had filled their initial corticosteroid prescription, compared with about 27% of the control families, a statistically significant difference. But the rate at which the intervention families filled the second prescription – the one they had to get from the child’s primary care pediatrician – dropped to roughly 20% of the intervention families, no different from the 18% rate among the control families. The researchers have not yet examined whether the breakdown in follow-up prescriptions occurred at the level of the primary care pediatrician or in the family’s failure to fill a second prescription that they received.

The follow-up data also showed that while on the initial course of an inhaled steroid, the children had, on average, a significant 2-day drop in the number of days they coughed while asleep, and a significant halving of the number of days when they experienced shortness of breath.

In addition, the first course of an inhaled corticosteroid led to a significant reduction in the use of albuterol as a rescue medication. Children in the intervention group had a 43% rate of never using albuterol or using it less than twice during follow-up, compared with 21% having this usage rate among the control children. At the other end of the spectrum, children in the intervention group had a 44% rate of using albuterol either daily or every other day during follow-up, compared with a 65% rate of such heavy use by the control children.

Dr. Sampayo said that she and her associates had no relevant financial disclosures.

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ED Prescription Failed to Jump-Start Inhaled Steroid for Asthmatic Kids

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PHILADELPHIA – Having emergency physicians start children with persistent asthma on a prescription of an inhaled corticosteroid failed to have a significant impact on the rate at which the families filled a second, follow-up prescription for the same drug from their primary care pediatrician, according to a controlled study with 153 children.

But the study results did show, for the first time in a controlled study of children, that intervention with an inhaled corticosteroid can significantly improve asthma symptoms over the short term, Dr. Esther M. Sampayo said at the annual meeting of the Eastern Society for Pediatric Research.

Dr. Esther M. Sampayo    

"National guidelines have recommended that emergency physicians consider initiating control medications [for children with asthma] in the emergency department," she said. When children don’t receive such a prescription, it’s "a missed opportunity for children who are high emergency department utilizers," said Dr. Sampayo, a pediatric emergency physician at Children’s Hospital of Philadelphia.

"We found that at 2 months [after the index emergency department visit], fewer than 20% of children actually filled a second prescription for their control medication," with similar rates in both the control and intervention groups of the study. This level of failure occurred even though when each child received the initial prescription, the researchers told the family to fill a follow-up prescription from the child’s primary care pediatrician, each pediatrician received an alert to write the second prescription, and virtually all the families had public or private insurance that covered the drug’s cost.

"We’re now testing a new intervention, sending parents a text message to remind them to refill their child’s prescription," Dr. Sampayo said in an interview.

The findings also highlighted the important role that emergency physicians can play in starting children on an inhaled corticosteroid. In prior studies, researchers asked emergency physicians why they generally did not start children with poorly controlled asthma on control medication. The physicians said that they didn’t view it as their appropriate role, and that this task was best reserved for primary care physicians. "All the pediatricians in our study said that the emergency department physicians should write the prescription. They want the emergency physician to do it," she said.

The study enrolled children seen in the emergency department of Children’s Hospital of Philadelphia with an average age of 5 years (range, 1-18 years) during 2006-2009. After randomization, the families of 74 children received a starter prescription for a 30-day supply of an inhaled corticosteroid, either budesonide for children aged 4 or younger, or fluticasone for those aged 5 or older, as well as educational materials and other standard discharge medications for asthma. The 78 control families received the same educational materials and discharge medications but no prescription for a corticosteroid.

By 8 weeks after the emergency department visit, about 63% of the intervention families had filled their initial corticosteroid prescription, compared with about 27% of the control families, a statistically significant difference. But the rate at which the intervention families filled the second prescription – the one they had to get from the child’s primary care pediatrician – dropped to roughly 20% of the intervention families, no different from the 18% rate among the control families. The researchers have not yet examined whether the breakdown in follow-up prescriptions occurred at the level of the primary care pediatrician or in the family’s failure to fill a second prescription that they received.

The follow-up data also showed that while on the initial course of an inhaled steroid, the children had, on average, a significant 2-day drop in the number of days they coughed while asleep, and a significant halving of the number of days when they experienced shortness of breath.

In addition, the first course of an inhaled corticosteroid led to a significant reduction in the use of albuterol as a rescue medication. Children in the intervention group had a 43% rate of never using albuterol or using it less than twice during follow-up, compared with 21% having this usage rate among the control children. At the other end of the spectrum, children in the intervention group had a 44% rate of using albuterol either daily or every other day during follow-up, compared with a 65% rate of such heavy use by the control children.

Dr. Sampayo said that she and her associates had no relevant financial disclosures.

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PHILADELPHIA – Having emergency physicians start children with persistent asthma on a prescription of an inhaled corticosteroid failed to have a significant impact on the rate at which the families filled a second, follow-up prescription for the same drug from their primary care pediatrician, according to a controlled study with 153 children.

But the study results did show, for the first time in a controlled study of children, that intervention with an inhaled corticosteroid can significantly improve asthma symptoms over the short term, Dr. Esther M. Sampayo said at the annual meeting of the Eastern Society for Pediatric Research.

Dr. Esther M. Sampayo    

"National guidelines have recommended that emergency physicians consider initiating control medications [for children with asthma] in the emergency department," she said. When children don’t receive such a prescription, it’s "a missed opportunity for children who are high emergency department utilizers," said Dr. Sampayo, a pediatric emergency physician at Children’s Hospital of Philadelphia.

"We found that at 2 months [after the index emergency department visit], fewer than 20% of children actually filled a second prescription for their control medication," with similar rates in both the control and intervention groups of the study. This level of failure occurred even though when each child received the initial prescription, the researchers told the family to fill a follow-up prescription from the child’s primary care pediatrician, each pediatrician received an alert to write the second prescription, and virtually all the families had public or private insurance that covered the drug’s cost.

"We’re now testing a new intervention, sending parents a text message to remind them to refill their child’s prescription," Dr. Sampayo said in an interview.

The findings also highlighted the important role that emergency physicians can play in starting children on an inhaled corticosteroid. In prior studies, researchers asked emergency physicians why they generally did not start children with poorly controlled asthma on control medication. The physicians said that they didn’t view it as their appropriate role, and that this task was best reserved for primary care physicians. "All the pediatricians in our study said that the emergency department physicians should write the prescription. They want the emergency physician to do it," she said.

The study enrolled children seen in the emergency department of Children’s Hospital of Philadelphia with an average age of 5 years (range, 1-18 years) during 2006-2009. After randomization, the families of 74 children received a starter prescription for a 30-day supply of an inhaled corticosteroid, either budesonide for children aged 4 or younger, or fluticasone for those aged 5 or older, as well as educational materials and other standard discharge medications for asthma. The 78 control families received the same educational materials and discharge medications but no prescription for a corticosteroid.

By 8 weeks after the emergency department visit, about 63% of the intervention families had filled their initial corticosteroid prescription, compared with about 27% of the control families, a statistically significant difference. But the rate at which the intervention families filled the second prescription – the one they had to get from the child’s primary care pediatrician – dropped to roughly 20% of the intervention families, no different from the 18% rate among the control families. The researchers have not yet examined whether the breakdown in follow-up prescriptions occurred at the level of the primary care pediatrician or in the family’s failure to fill a second prescription that they received.

The follow-up data also showed that while on the initial course of an inhaled steroid, the children had, on average, a significant 2-day drop in the number of days they coughed while asleep, and a significant halving of the number of days when they experienced shortness of breath.

In addition, the first course of an inhaled corticosteroid led to a significant reduction in the use of albuterol as a rescue medication. Children in the intervention group had a 43% rate of never using albuterol or using it less than twice during follow-up, compared with 21% having this usage rate among the control children. At the other end of the spectrum, children in the intervention group had a 44% rate of using albuterol either daily or every other day during follow-up, compared with a 65% rate of such heavy use by the control children.

Dr. Sampayo said that she and her associates had no relevant financial disclosures.

PHILADELPHIA – Having emergency physicians start children with persistent asthma on a prescription of an inhaled corticosteroid failed to have a significant impact on the rate at which the families filled a second, follow-up prescription for the same drug from their primary care pediatrician, according to a controlled study with 153 children.

But the study results did show, for the first time in a controlled study of children, that intervention with an inhaled corticosteroid can significantly improve asthma symptoms over the short term, Dr. Esther M. Sampayo said at the annual meeting of the Eastern Society for Pediatric Research.

Dr. Esther M. Sampayo    

"National guidelines have recommended that emergency physicians consider initiating control medications [for children with asthma] in the emergency department," she said. When children don’t receive such a prescription, it’s "a missed opportunity for children who are high emergency department utilizers," said Dr. Sampayo, a pediatric emergency physician at Children’s Hospital of Philadelphia.

"We found that at 2 months [after the index emergency department visit], fewer than 20% of children actually filled a second prescription for their control medication," with similar rates in both the control and intervention groups of the study. This level of failure occurred even though when each child received the initial prescription, the researchers told the family to fill a follow-up prescription from the child’s primary care pediatrician, each pediatrician received an alert to write the second prescription, and virtually all the families had public or private insurance that covered the drug’s cost.

"We’re now testing a new intervention, sending parents a text message to remind them to refill their child’s prescription," Dr. Sampayo said in an interview.

The findings also highlighted the important role that emergency physicians can play in starting children on an inhaled corticosteroid. In prior studies, researchers asked emergency physicians why they generally did not start children with poorly controlled asthma on control medication. The physicians said that they didn’t view it as their appropriate role, and that this task was best reserved for primary care physicians. "All the pediatricians in our study said that the emergency department physicians should write the prescription. They want the emergency physician to do it," she said.

The study enrolled children seen in the emergency department of Children’s Hospital of Philadelphia with an average age of 5 years (range, 1-18 years) during 2006-2009. After randomization, the families of 74 children received a starter prescription for a 30-day supply of an inhaled corticosteroid, either budesonide for children aged 4 or younger, or fluticasone for those aged 5 or older, as well as educational materials and other standard discharge medications for asthma. The 78 control families received the same educational materials and discharge medications but no prescription for a corticosteroid.

By 8 weeks after the emergency department visit, about 63% of the intervention families had filled their initial corticosteroid prescription, compared with about 27% of the control families, a statistically significant difference. But the rate at which the intervention families filled the second prescription – the one they had to get from the child’s primary care pediatrician – dropped to roughly 20% of the intervention families, no different from the 18% rate among the control families. The researchers have not yet examined whether the breakdown in follow-up prescriptions occurred at the level of the primary care pediatrician or in the family’s failure to fill a second prescription that they received.

The follow-up data also showed that while on the initial course of an inhaled steroid, the children had, on average, a significant 2-day drop in the number of days they coughed while asleep, and a significant halving of the number of days when they experienced shortness of breath.

In addition, the first course of an inhaled corticosteroid led to a significant reduction in the use of albuterol as a rescue medication. Children in the intervention group had a 43% rate of never using albuterol or using it less than twice during follow-up, compared with 21% having this usage rate among the control children. At the other end of the spectrum, children in the intervention group had a 44% rate of using albuterol either daily or every other day during follow-up, compared with a 65% rate of such heavy use by the control children.

Dr. Sampayo said that she and her associates had no relevant financial disclosures.

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Major Finding: An emergency department prescription for an inhaled corticosteroid given to children with asthma failed to significantly boost the rate at which the family filled a follow-up prescription from their primary care pediatrician. But the inhaled steroid did improve the children’s asthma symptoms over the short term.

Data Source: Randomized, single-center study of 153 children with asthma seen in the ED of a pediatric hospital.

Disclosures: Dr. Sampayo said that she and her associates had no relevant financial disclosures.