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Half of Recurrent ACS Due to Existing 'Mild' Lesions
Approximately half of the acute coronary syndromes that recur within 3 years of an index ACS treated percutaneously involve a different lesion that was visualized on angiography at that time but was not severe enough to require treatment, according to a report in the Jan. 20 issue of the New England Journal of Medicine.
The rate of recurrent major adverse cardiovascular events was 20% in this multicenter prospective study involving 697 patients with ACS who were successfully treated with PCI and medical therapy, then followed for 3 years, said Dr. Gregg W. Stone of Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, and his associates.
They conducted the Providing Regional Observations to Study Predictors of Events in the Coronary Tree (PROSPECT) study using new imaging tools that help characterize the content of coronary lesions, to identify factors that raise the risk for recurrent ACS.
The study, conducted at 37 medical centers in the United States and Europe, was funded by Abbott Vascular and Volcano. Abbott participated in the study design, site selection, data collection, and data analysis.
Study subjects were enrolled after undergoing successful and uncomplicated PCI for all coronary lesions thought to be responsible for their index ACS. At that time, the subjects underwent angiography, then conventional gray-scale intravascular ultrasonography and the newly available radiofrequency intravascular ultrasonography of the left main coronary artery and the proximal 6-8 cm of each of the major epicardial coronary arteries.
Unlike the other imaging techniques, radiofrequency intravascular ultrasonography provides data about tissue composition. It allowed the investigators to classify coronary lesions as thin-cap fibroatheroma, thick-cap fibroatheroma, pathologic intimal thickening, fibrotic plaque, or fibrocalcific plaque.
The median age of the study subjects was 58 years; 24% were women, and 17% had diabetes.
"We found that approximately one in five patients with [ACS] ... had recurrent major adverse cardiovascular events within 3 years. Events were nearly equally divided between those related to initially treated lesions and those related to previously untreated lesions," Dr. Stone and his colleagues said.
"Most events were rehospitalizations for unstable or progressive angina; death from cardiac causes, cardiac arrest, and MI were less common," they noted.
Radiofrequency intravascular ultrasonography at baseline revealed that most of the "nonculprit" coronary lesions – those that had been considered mild on the index angiography and were not treated at that time – were characterized by a large plaque burden, a small luminal area, or both. Half of them also were thin-cap fibroatheromas. These traits had not been visible on conventional angiography.
In contrast, no major events arose from arterial segments with a plaque burden that blocked less than 40% of the lumen. And nonfibroatheromas rarely caused such events, regardless of their plaque burden or the luminal area they blocked.
These study findings suggest that thin-cap fibroatheromas, lesions with a large plaque burden, and lesions with a small luminal area are particularly prone to cause recurrent ACS.
However, "there are several reasons why the methods we have used are not currently suitable for clinical application as a means of identifying sites in the coronary vasculature for potential intervention," the investigators noted (N. Engl. J. Med. 2011:364:226-35).
First, this method lacks specificity at present. Radiofrequency intravascular ultrasonography identified a total of 595 thin-cap atheromas in these subjects, but only 26 of them caused recurrent ACS. Similarly, fewer than 10% of the lesions that carried plaque burdens of 70% or more and the lesions with a 4-mm or smaller luminal area caused recurrent ACS.
"Even when all three predictive variables were present, the event rate rose to only 18%," they said.
Second, catheters used for this type of ultrasonography could only access the proximal 6-8 cm of the coronary tree. This meant that only 51 of the 106 "nonculprit" lesions seen on angiography could be evaluated by radiofrequency intravascular ultrasonography.
Third, the technique was associated with very serious adverse events in 11 patients in this study: 10 coronary dissections and 1 perforation, which in turn caused 4 nonfatal MIs.
And fourth, it is still unclear what therapies should be used when the technique identifies these high-risk lesions.
Approximately half of the acute coronary syndromes that recur within 3 years of an index ACS treated percutaneously involve a different lesion that was visualized on angiography at that time but was not severe enough to require treatment, according to a report in the Jan. 20 issue of the New England Journal of Medicine.
The rate of recurrent major adverse cardiovascular events was 20% in this multicenter prospective study involving 697 patients with ACS who were successfully treated with PCI and medical therapy, then followed for 3 years, said Dr. Gregg W. Stone of Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, and his associates.
They conducted the Providing Regional Observations to Study Predictors of Events in the Coronary Tree (PROSPECT) study using new imaging tools that help characterize the content of coronary lesions, to identify factors that raise the risk for recurrent ACS.
The study, conducted at 37 medical centers in the United States and Europe, was funded by Abbott Vascular and Volcano. Abbott participated in the study design, site selection, data collection, and data analysis.
Study subjects were enrolled after undergoing successful and uncomplicated PCI for all coronary lesions thought to be responsible for their index ACS. At that time, the subjects underwent angiography, then conventional gray-scale intravascular ultrasonography and the newly available radiofrequency intravascular ultrasonography of the left main coronary artery and the proximal 6-8 cm of each of the major epicardial coronary arteries.
Unlike the other imaging techniques, radiofrequency intravascular ultrasonography provides data about tissue composition. It allowed the investigators to classify coronary lesions as thin-cap fibroatheroma, thick-cap fibroatheroma, pathologic intimal thickening, fibrotic plaque, or fibrocalcific plaque.
The median age of the study subjects was 58 years; 24% were women, and 17% had diabetes.
"We found that approximately one in five patients with [ACS] ... had recurrent major adverse cardiovascular events within 3 years. Events were nearly equally divided between those related to initially treated lesions and those related to previously untreated lesions," Dr. Stone and his colleagues said.
"Most events were rehospitalizations for unstable or progressive angina; death from cardiac causes, cardiac arrest, and MI were less common," they noted.
Radiofrequency intravascular ultrasonography at baseline revealed that most of the "nonculprit" coronary lesions – those that had been considered mild on the index angiography and were not treated at that time – were characterized by a large plaque burden, a small luminal area, or both. Half of them also were thin-cap fibroatheromas. These traits had not been visible on conventional angiography.
In contrast, no major events arose from arterial segments with a plaque burden that blocked less than 40% of the lumen. And nonfibroatheromas rarely caused such events, regardless of their plaque burden or the luminal area they blocked.
These study findings suggest that thin-cap fibroatheromas, lesions with a large plaque burden, and lesions with a small luminal area are particularly prone to cause recurrent ACS.
However, "there are several reasons why the methods we have used are not currently suitable for clinical application as a means of identifying sites in the coronary vasculature for potential intervention," the investigators noted (N. Engl. J. Med. 2011:364:226-35).
First, this method lacks specificity at present. Radiofrequency intravascular ultrasonography identified a total of 595 thin-cap atheromas in these subjects, but only 26 of them caused recurrent ACS. Similarly, fewer than 10% of the lesions that carried plaque burdens of 70% or more and the lesions with a 4-mm or smaller luminal area caused recurrent ACS.
"Even when all three predictive variables were present, the event rate rose to only 18%," they said.
Second, catheters used for this type of ultrasonography could only access the proximal 6-8 cm of the coronary tree. This meant that only 51 of the 106 "nonculprit" lesions seen on angiography could be evaluated by radiofrequency intravascular ultrasonography.
Third, the technique was associated with very serious adverse events in 11 patients in this study: 10 coronary dissections and 1 perforation, which in turn caused 4 nonfatal MIs.
And fourth, it is still unclear what therapies should be used when the technique identifies these high-risk lesions.
Approximately half of the acute coronary syndromes that recur within 3 years of an index ACS treated percutaneously involve a different lesion that was visualized on angiography at that time but was not severe enough to require treatment, according to a report in the Jan. 20 issue of the New England Journal of Medicine.
The rate of recurrent major adverse cardiovascular events was 20% in this multicenter prospective study involving 697 patients with ACS who were successfully treated with PCI and medical therapy, then followed for 3 years, said Dr. Gregg W. Stone of Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, and his associates.
They conducted the Providing Regional Observations to Study Predictors of Events in the Coronary Tree (PROSPECT) study using new imaging tools that help characterize the content of coronary lesions, to identify factors that raise the risk for recurrent ACS.
The study, conducted at 37 medical centers in the United States and Europe, was funded by Abbott Vascular and Volcano. Abbott participated in the study design, site selection, data collection, and data analysis.
Study subjects were enrolled after undergoing successful and uncomplicated PCI for all coronary lesions thought to be responsible for their index ACS. At that time, the subjects underwent angiography, then conventional gray-scale intravascular ultrasonography and the newly available radiofrequency intravascular ultrasonography of the left main coronary artery and the proximal 6-8 cm of each of the major epicardial coronary arteries.
Unlike the other imaging techniques, radiofrequency intravascular ultrasonography provides data about tissue composition. It allowed the investigators to classify coronary lesions as thin-cap fibroatheroma, thick-cap fibroatheroma, pathologic intimal thickening, fibrotic plaque, or fibrocalcific plaque.
The median age of the study subjects was 58 years; 24% were women, and 17% had diabetes.
"We found that approximately one in five patients with [ACS] ... had recurrent major adverse cardiovascular events within 3 years. Events were nearly equally divided between those related to initially treated lesions and those related to previously untreated lesions," Dr. Stone and his colleagues said.
"Most events were rehospitalizations for unstable or progressive angina; death from cardiac causes, cardiac arrest, and MI were less common," they noted.
Radiofrequency intravascular ultrasonography at baseline revealed that most of the "nonculprit" coronary lesions – those that had been considered mild on the index angiography and were not treated at that time – were characterized by a large plaque burden, a small luminal area, or both. Half of them also were thin-cap fibroatheromas. These traits had not been visible on conventional angiography.
In contrast, no major events arose from arterial segments with a plaque burden that blocked less than 40% of the lumen. And nonfibroatheromas rarely caused such events, regardless of their plaque burden or the luminal area they blocked.
These study findings suggest that thin-cap fibroatheromas, lesions with a large plaque burden, and lesions with a small luminal area are particularly prone to cause recurrent ACS.
However, "there are several reasons why the methods we have used are not currently suitable for clinical application as a means of identifying sites in the coronary vasculature for potential intervention," the investigators noted (N. Engl. J. Med. 2011:364:226-35).
First, this method lacks specificity at present. Radiofrequency intravascular ultrasonography identified a total of 595 thin-cap atheromas in these subjects, but only 26 of them caused recurrent ACS. Similarly, fewer than 10% of the lesions that carried plaque burdens of 70% or more and the lesions with a 4-mm or smaller luminal area caused recurrent ACS.
"Even when all three predictive variables were present, the event rate rose to only 18%," they said.
Second, catheters used for this type of ultrasonography could only access the proximal 6-8 cm of the coronary tree. This meant that only 51 of the 106 "nonculprit" lesions seen on angiography could be evaluated by radiofrequency intravascular ultrasonography.
Third, the technique was associated with very serious adverse events in 11 patients in this study: 10 coronary dissections and 1 perforation, which in turn caused 4 nonfatal MIs.
And fourth, it is still unclear what therapies should be used when the technique identifies these high-risk lesions.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Electronic Records Fail to Deliver Better-Quality Outpatient Care
Electronic health records, either with or without features to aid clinical decision making, failed to improve the quality of outpatient care in a study of more than 240,000 physician visits across the country, according to a report published online Jan. 24 in Archives of Internal Medicine.
The study findings "cast doubt on the argument that the use of electronic health records is a ‘magic bullet’ for health care quality improvement, as some advocates imply," according to Max J. Romano and Dr. Randall S. Stafford of the prevention research center at Stanford (Calif.) University.
"Since 1991, the Institute of Medicine has repeatedly called for increasing electronic health record (EHR) use to improve health care quality," the authors wrote, adding that "the American Reinvestment and Recovery Act stimulus bill set aside $19.2 billion to promote health information technology use in the United States, with the underlying assumption that more health IT is better.
"Nonetheless, evidence linking increased national use of outpatient EHRs to improved quality is lacking," as are data supporting included clinical decision support tools, Mr. Romano and Dr. Stafford said.
They analyzed data from two nationally representative samples collected by the National Center for Health Statistics in 2005-2007, the most recent years available. This included 243,478 patient visits to office-based, emergency department, and outpatient department physicians in family medicine, internal medicine, geriatrics, pediatrics, and general practice.
To evaluate the quality of care provided during these visits, 20 quality indicators were assessed in five areas: pharmacologic management of chronic diseases (such as atrial fibrillation, coronary artery disease, heart failure, hyperlipidemia, asthma, and hypertension); appropriate antibiotic use in urinary tract and viral upper respiratory tract infections; preventive counseling regarding diet, exercise, and smoking cessation; appropriate use of screening tests such as blood pressure measurement, urinalysis, and echocardiography; and inappropriate prescribing in the elderly.
Electronic health records were used in approximately 30% of all patient visits, and clinical decision support features were used in 17%. Neither EHR nor clinical decision support features were associated with higher-quality care.
When an EHR was used, care quality was better than when no EHR was used for only 1 of the 20 quality indicators (dietary counseling). Similarly, when a clinical decision support feature was used, care quality was better for only 1 of 20 quality indicators (avoidance of unnecessary electrocardiography during routine examinations).
An analysis of the office-based visits separately from the hospital-based visits showed similar results. The use of a clinical decision support feature was helpful only in avoiding inappropriate ECGs in office-based visits. And such features were helpful in promoting smoking cessation counseling in hospital-based visits, but actually were linked to poorer performance in the use of inhaled corticosteroids for asthma and the use of appropriate blood pressure monitoring.
The investigators found that EHRs were used much more frequently during visits in the Western United States than in other regions. A post-hoc analysis showed that this did not correlate with improved care in the Western United States. "Western visits had higher quality than other regions for 2 indicators (appropriate antibiotic use in respiratory infection and avoiding inappropriate ECG ordering), worse quality for 3 indicators (UTI antibiotic selection, diet counseling, and exercise counseling), and similar quality for the remaining 15 indicators," they wrote (Arch. Intern. Med. 2011 Jan. 24 [doi:10.1001/archinternmed.2010.527]).
Since the use of EHRs and clinical decision support features is expected to increase because of federal incentives associated with their use, the real world performance of such systems "should be monitored carefully and [their] impact and cost evaluated rigorously," Mr. Romano and Dr. Stafford added.
In invited commentary accompanying the report, Dr. Clement McDonald and Dr. Swapna Abhyankar said that the "dismal" results reported by Mr. Romano and Dr. Stafford were surprising, given that previously reported randomized controlled trials had found that the use of EHRs and clinical decision support features were strongly beneficial (Arch. Intern. Med. 2011 Jan. 24 [doi:10.1001/archinternmed.2010.518]).
"We know from multiple randomized controlled trials that well-implemented clinical decision support systems can produce large and important improvements in care processes. What we do not know is whether we can extend these results to a national level.
"The results of Romano and Stafford’s study suggest not. However, we suspect that the EHR and clinical decision support systems in use at the time of their study were immature, did not cover many of the guidelines that the study targeted, and had incomplete patient data," said Dr. McDonald and Dr. Abhyankar of the National Library of Medicine in Bethesda, Md.
They reported no relevant financial disclosures. This study was supported by the National Heart, Lung, and Blood Institute and Stanford University.
The "dismal" results reported by Mr. Romano and Dr. Stafford were surprising, given that previously reported randomized controlled trials had found that the use of EHRs and clinical decision support features were strongly beneficial, said Dr. Clement McDonald and Dr. Swapna Abhyankar.
"We know from multiple randomized controlled trials that well-implemented clinical decision support systems can produce large and important improvements in care processes. What we do not know is whether we can extend these results to a national level.
"The results of Romano and Stafford’s study suggest not. However, we suspect that the EHR and clinical decision support systems in use at the time of their study were immature, did not cover many of the guidelines that the study targeted, and had incomplete patient data," they wrote.
Clement McDonald, M.D., and Swapna Abhyankar, M.D., are with the National Library of Medicine in Bethesda, Md. They reported no relevant financial disclosures. These comments were taken from their invited commentary that accompanied the report by Mr. Romano and Dr. Stafford (Arch. Intern. Med. 2011 Jan. 24 [doi:10.1001/archinternmed.2010.518]).
The "dismal" results reported by Mr. Romano and Dr. Stafford were surprising, given that previously reported randomized controlled trials had found that the use of EHRs and clinical decision support features were strongly beneficial, said Dr. Clement McDonald and Dr. Swapna Abhyankar.
"We know from multiple randomized controlled trials that well-implemented clinical decision support systems can produce large and important improvements in care processes. What we do not know is whether we can extend these results to a national level.
"The results of Romano and Stafford’s study suggest not. However, we suspect that the EHR and clinical decision support systems in use at the time of their study were immature, did not cover many of the guidelines that the study targeted, and had incomplete patient data," they wrote.
Clement McDonald, M.D., and Swapna Abhyankar, M.D., are with the National Library of Medicine in Bethesda, Md. They reported no relevant financial disclosures. These comments were taken from their invited commentary that accompanied the report by Mr. Romano and Dr. Stafford (Arch. Intern. Med. 2011 Jan. 24 [doi:10.1001/archinternmed.2010.518]).
The "dismal" results reported by Mr. Romano and Dr. Stafford were surprising, given that previously reported randomized controlled trials had found that the use of EHRs and clinical decision support features were strongly beneficial, said Dr. Clement McDonald and Dr. Swapna Abhyankar.
"We know from multiple randomized controlled trials that well-implemented clinical decision support systems can produce large and important improvements in care processes. What we do not know is whether we can extend these results to a national level.
"The results of Romano and Stafford’s study suggest not. However, we suspect that the EHR and clinical decision support systems in use at the time of their study were immature, did not cover many of the guidelines that the study targeted, and had incomplete patient data," they wrote.
Clement McDonald, M.D., and Swapna Abhyankar, M.D., are with the National Library of Medicine in Bethesda, Md. They reported no relevant financial disclosures. These comments were taken from their invited commentary that accompanied the report by Mr. Romano and Dr. Stafford (Arch. Intern. Med. 2011 Jan. 24 [doi:10.1001/archinternmed.2010.518]).
Electronic health records, either with or without features to aid clinical decision making, failed to improve the quality of outpatient care in a study of more than 240,000 physician visits across the country, according to a report published online Jan. 24 in Archives of Internal Medicine.
The study findings "cast doubt on the argument that the use of electronic health records is a ‘magic bullet’ for health care quality improvement, as some advocates imply," according to Max J. Romano and Dr. Randall S. Stafford of the prevention research center at Stanford (Calif.) University.
"Since 1991, the Institute of Medicine has repeatedly called for increasing electronic health record (EHR) use to improve health care quality," the authors wrote, adding that "the American Reinvestment and Recovery Act stimulus bill set aside $19.2 billion to promote health information technology use in the United States, with the underlying assumption that more health IT is better.
"Nonetheless, evidence linking increased national use of outpatient EHRs to improved quality is lacking," as are data supporting included clinical decision support tools, Mr. Romano and Dr. Stafford said.
They analyzed data from two nationally representative samples collected by the National Center for Health Statistics in 2005-2007, the most recent years available. This included 243,478 patient visits to office-based, emergency department, and outpatient department physicians in family medicine, internal medicine, geriatrics, pediatrics, and general practice.
To evaluate the quality of care provided during these visits, 20 quality indicators were assessed in five areas: pharmacologic management of chronic diseases (such as atrial fibrillation, coronary artery disease, heart failure, hyperlipidemia, asthma, and hypertension); appropriate antibiotic use in urinary tract and viral upper respiratory tract infections; preventive counseling regarding diet, exercise, and smoking cessation; appropriate use of screening tests such as blood pressure measurement, urinalysis, and echocardiography; and inappropriate prescribing in the elderly.
Electronic health records were used in approximately 30% of all patient visits, and clinical decision support features were used in 17%. Neither EHR nor clinical decision support features were associated with higher-quality care.
When an EHR was used, care quality was better than when no EHR was used for only 1 of the 20 quality indicators (dietary counseling). Similarly, when a clinical decision support feature was used, care quality was better for only 1 of 20 quality indicators (avoidance of unnecessary electrocardiography during routine examinations).
An analysis of the office-based visits separately from the hospital-based visits showed similar results. The use of a clinical decision support feature was helpful only in avoiding inappropriate ECGs in office-based visits. And such features were helpful in promoting smoking cessation counseling in hospital-based visits, but actually were linked to poorer performance in the use of inhaled corticosteroids for asthma and the use of appropriate blood pressure monitoring.
The investigators found that EHRs were used much more frequently during visits in the Western United States than in other regions. A post-hoc analysis showed that this did not correlate with improved care in the Western United States. "Western visits had higher quality than other regions for 2 indicators (appropriate antibiotic use in respiratory infection and avoiding inappropriate ECG ordering), worse quality for 3 indicators (UTI antibiotic selection, diet counseling, and exercise counseling), and similar quality for the remaining 15 indicators," they wrote (Arch. Intern. Med. 2011 Jan. 24 [doi:10.1001/archinternmed.2010.527]).
Since the use of EHRs and clinical decision support features is expected to increase because of federal incentives associated with their use, the real world performance of such systems "should be monitored carefully and [their] impact and cost evaluated rigorously," Mr. Romano and Dr. Stafford added.
In invited commentary accompanying the report, Dr. Clement McDonald and Dr. Swapna Abhyankar said that the "dismal" results reported by Mr. Romano and Dr. Stafford were surprising, given that previously reported randomized controlled trials had found that the use of EHRs and clinical decision support features were strongly beneficial (Arch. Intern. Med. 2011 Jan. 24 [doi:10.1001/archinternmed.2010.518]).
"We know from multiple randomized controlled trials that well-implemented clinical decision support systems can produce large and important improvements in care processes. What we do not know is whether we can extend these results to a national level.
"The results of Romano and Stafford’s study suggest not. However, we suspect that the EHR and clinical decision support systems in use at the time of their study were immature, did not cover many of the guidelines that the study targeted, and had incomplete patient data," said Dr. McDonald and Dr. Abhyankar of the National Library of Medicine in Bethesda, Md.
They reported no relevant financial disclosures. This study was supported by the National Heart, Lung, and Blood Institute and Stanford University.
Electronic health records, either with or without features to aid clinical decision making, failed to improve the quality of outpatient care in a study of more than 240,000 physician visits across the country, according to a report published online Jan. 24 in Archives of Internal Medicine.
The study findings "cast doubt on the argument that the use of electronic health records is a ‘magic bullet’ for health care quality improvement, as some advocates imply," according to Max J. Romano and Dr. Randall S. Stafford of the prevention research center at Stanford (Calif.) University.
"Since 1991, the Institute of Medicine has repeatedly called for increasing electronic health record (EHR) use to improve health care quality," the authors wrote, adding that "the American Reinvestment and Recovery Act stimulus bill set aside $19.2 billion to promote health information technology use in the United States, with the underlying assumption that more health IT is better.
"Nonetheless, evidence linking increased national use of outpatient EHRs to improved quality is lacking," as are data supporting included clinical decision support tools, Mr. Romano and Dr. Stafford said.
They analyzed data from two nationally representative samples collected by the National Center for Health Statistics in 2005-2007, the most recent years available. This included 243,478 patient visits to office-based, emergency department, and outpatient department physicians in family medicine, internal medicine, geriatrics, pediatrics, and general practice.
To evaluate the quality of care provided during these visits, 20 quality indicators were assessed in five areas: pharmacologic management of chronic diseases (such as atrial fibrillation, coronary artery disease, heart failure, hyperlipidemia, asthma, and hypertension); appropriate antibiotic use in urinary tract and viral upper respiratory tract infections; preventive counseling regarding diet, exercise, and smoking cessation; appropriate use of screening tests such as blood pressure measurement, urinalysis, and echocardiography; and inappropriate prescribing in the elderly.
Electronic health records were used in approximately 30% of all patient visits, and clinical decision support features were used in 17%. Neither EHR nor clinical decision support features were associated with higher-quality care.
When an EHR was used, care quality was better than when no EHR was used for only 1 of the 20 quality indicators (dietary counseling). Similarly, when a clinical decision support feature was used, care quality was better for only 1 of 20 quality indicators (avoidance of unnecessary electrocardiography during routine examinations).
An analysis of the office-based visits separately from the hospital-based visits showed similar results. The use of a clinical decision support feature was helpful only in avoiding inappropriate ECGs in office-based visits. And such features were helpful in promoting smoking cessation counseling in hospital-based visits, but actually were linked to poorer performance in the use of inhaled corticosteroids for asthma and the use of appropriate blood pressure monitoring.
The investigators found that EHRs were used much more frequently during visits in the Western United States than in other regions. A post-hoc analysis showed that this did not correlate with improved care in the Western United States. "Western visits had higher quality than other regions for 2 indicators (appropriate antibiotic use in respiratory infection and avoiding inappropriate ECG ordering), worse quality for 3 indicators (UTI antibiotic selection, diet counseling, and exercise counseling), and similar quality for the remaining 15 indicators," they wrote (Arch. Intern. Med. 2011 Jan. 24 [doi:10.1001/archinternmed.2010.527]).
Since the use of EHRs and clinical decision support features is expected to increase because of federal incentives associated with their use, the real world performance of such systems "should be monitored carefully and [their] impact and cost evaluated rigorously," Mr. Romano and Dr. Stafford added.
In invited commentary accompanying the report, Dr. Clement McDonald and Dr. Swapna Abhyankar said that the "dismal" results reported by Mr. Romano and Dr. Stafford were surprising, given that previously reported randomized controlled trials had found that the use of EHRs and clinical decision support features were strongly beneficial (Arch. Intern. Med. 2011 Jan. 24 [doi:10.1001/archinternmed.2010.518]).
"We know from multiple randomized controlled trials that well-implemented clinical decision support systems can produce large and important improvements in care processes. What we do not know is whether we can extend these results to a national level.
"The results of Romano and Stafford’s study suggest not. However, we suspect that the EHR and clinical decision support systems in use at the time of their study were immature, did not cover many of the guidelines that the study targeted, and had incomplete patient data," said Dr. McDonald and Dr. Abhyankar of the National Library of Medicine in Bethesda, Md.
They reported no relevant financial disclosures. This study was supported by the National Heart, Lung, and Blood Institute and Stanford University.
FROM ARCHIVES OF INTERNAL MEDICINE
Major Finding: Neither electronic health records nor clinical decision support tools were associated with improved care in outpatient visits with family medicine, internal medicine, geriatrics, pediatrics, or general practice physicians.
Data Source: Analysis of national survey data on 243,478 visits with outpatient physicians in 2005-2007.
Disclosures: This study was supported by the National Heart, Lung, and Blood Institute and Stanford University.
PCOS Appears to Be Manifesting at Younger Ages
Polycystic ovary syndrome appears to be manifesting at younger ages than previously thought, a study has shown.
The disorder should be considered and a thorough work-up performed in prepubertal girls who have risk factors suggestive of PCOS, with particular attention given to hyperinsulinemia and early pubarche and thelarche, said Dr. Jason Bronstein and his associates at New York University.
In what they described as the largest pediatric PCOS study to date, the researchers found "a large subgroup of young PCOS girls with characteristic metabolic derangements at a younger age, suggesting a need for early therapeutic interventions." Early onset of PCOS does not portend well for future complications such as infertility, metabolic syndrome, and vascular disease. However, earlier recognition and treatment of PCOS might reduce morbidity in later adolescence and adulthood, they noted.
The investigators performed a retrospective, cross-sectional chart study of 58 patients from diverse ethnic backgrounds who attended two large, urban tertiary care centers and were diagnosed as having PCOS between ages 9 and 18. Fifteen (26%) of these subjects were preadolescents aged 9-12, and 43 (74%) were adolescents aged 13-18 years.
The severity of PCOS was similar between preadolescents and adolescents. Hyperinsulinemia was present in similar proportions of both groups, indicating that metabolic derangement is already present in the youngest girls with PCOS.
However, preadolescent girls were different in that they had significantly earlier pubarche and thelarche than did adolescent girls with PCOS, and the disorder developed much sooner after thelarche in the younger girls. Clinicians should look for early pubarche and thelarche in girls predisposed to PCOS, the investigators said (J. Pediatr. Adolesc. Gynecol. 2011;24:15-20).
The two groups also had similar risk factors. Mothers or other relatives had PCOS in approximately 14% of the study subjects, and there were no significant differences between preadolescents and adolescents in historical risk factors such as gestational age at birth, birth weight, childhood obesity, or family history of obesity, diabetes, or hypertension.
There also were no differences between preadolescents and adolescents in clinical risk factors such as body mass index, acne, hirsutism, alopecia, or hyperandrogenism, and no differences in biochemical risk factors such as serum total testosterone and free testosterone levels, insulin resistance, HDL levels, triglyceride levels, or fasting glucose levels.
These findings show that "pediatricians need a high index of suspicion in order to diagnose PCOS in preadolescents. We recommend that pediatricians ascertain risk for PCOS in their patients, including maternal factors, family history, birth weight, metabolic factors, and history of premature pubarche and/or early thelarche," Dr. Bronstein and his colleagues said.
No funding sources or financial conflicts of interest were reported.
Polycystic ovary syndrome appears to be manifesting at younger ages than previously thought, a study has shown.
The disorder should be considered and a thorough work-up performed in prepubertal girls who have risk factors suggestive of PCOS, with particular attention given to hyperinsulinemia and early pubarche and thelarche, said Dr. Jason Bronstein and his associates at New York University.
In what they described as the largest pediatric PCOS study to date, the researchers found "a large subgroup of young PCOS girls with characteristic metabolic derangements at a younger age, suggesting a need for early therapeutic interventions." Early onset of PCOS does not portend well for future complications such as infertility, metabolic syndrome, and vascular disease. However, earlier recognition and treatment of PCOS might reduce morbidity in later adolescence and adulthood, they noted.
The investigators performed a retrospective, cross-sectional chart study of 58 patients from diverse ethnic backgrounds who attended two large, urban tertiary care centers and were diagnosed as having PCOS between ages 9 and 18. Fifteen (26%) of these subjects were preadolescents aged 9-12, and 43 (74%) were adolescents aged 13-18 years.
The severity of PCOS was similar between preadolescents and adolescents. Hyperinsulinemia was present in similar proportions of both groups, indicating that metabolic derangement is already present in the youngest girls with PCOS.
However, preadolescent girls were different in that they had significantly earlier pubarche and thelarche than did adolescent girls with PCOS, and the disorder developed much sooner after thelarche in the younger girls. Clinicians should look for early pubarche and thelarche in girls predisposed to PCOS, the investigators said (J. Pediatr. Adolesc. Gynecol. 2011;24:15-20).
The two groups also had similar risk factors. Mothers or other relatives had PCOS in approximately 14% of the study subjects, and there were no significant differences between preadolescents and adolescents in historical risk factors such as gestational age at birth, birth weight, childhood obesity, or family history of obesity, diabetes, or hypertension.
There also were no differences between preadolescents and adolescents in clinical risk factors such as body mass index, acne, hirsutism, alopecia, or hyperandrogenism, and no differences in biochemical risk factors such as serum total testosterone and free testosterone levels, insulin resistance, HDL levels, triglyceride levels, or fasting glucose levels.
These findings show that "pediatricians need a high index of suspicion in order to diagnose PCOS in preadolescents. We recommend that pediatricians ascertain risk for PCOS in their patients, including maternal factors, family history, birth weight, metabolic factors, and history of premature pubarche and/or early thelarche," Dr. Bronstein and his colleagues said.
No funding sources or financial conflicts of interest were reported.
Polycystic ovary syndrome appears to be manifesting at younger ages than previously thought, a study has shown.
The disorder should be considered and a thorough work-up performed in prepubertal girls who have risk factors suggestive of PCOS, with particular attention given to hyperinsulinemia and early pubarche and thelarche, said Dr. Jason Bronstein and his associates at New York University.
In what they described as the largest pediatric PCOS study to date, the researchers found "a large subgroup of young PCOS girls with characteristic metabolic derangements at a younger age, suggesting a need for early therapeutic interventions." Early onset of PCOS does not portend well for future complications such as infertility, metabolic syndrome, and vascular disease. However, earlier recognition and treatment of PCOS might reduce morbidity in later adolescence and adulthood, they noted.
The investigators performed a retrospective, cross-sectional chart study of 58 patients from diverse ethnic backgrounds who attended two large, urban tertiary care centers and were diagnosed as having PCOS between ages 9 and 18. Fifteen (26%) of these subjects were preadolescents aged 9-12, and 43 (74%) were adolescents aged 13-18 years.
The severity of PCOS was similar between preadolescents and adolescents. Hyperinsulinemia was present in similar proportions of both groups, indicating that metabolic derangement is already present in the youngest girls with PCOS.
However, preadolescent girls were different in that they had significantly earlier pubarche and thelarche than did adolescent girls with PCOS, and the disorder developed much sooner after thelarche in the younger girls. Clinicians should look for early pubarche and thelarche in girls predisposed to PCOS, the investigators said (J. Pediatr. Adolesc. Gynecol. 2011;24:15-20).
The two groups also had similar risk factors. Mothers or other relatives had PCOS in approximately 14% of the study subjects, and there were no significant differences between preadolescents and adolescents in historical risk factors such as gestational age at birth, birth weight, childhood obesity, or family history of obesity, diabetes, or hypertension.
There also were no differences between preadolescents and adolescents in clinical risk factors such as body mass index, acne, hirsutism, alopecia, or hyperandrogenism, and no differences in biochemical risk factors such as serum total testosterone and free testosterone levels, insulin resistance, HDL levels, triglyceride levels, or fasting glucose levels.
These findings show that "pediatricians need a high index of suspicion in order to diagnose PCOS in preadolescents. We recommend that pediatricians ascertain risk for PCOS in their patients, including maternal factors, family history, birth weight, metabolic factors, and history of premature pubarche and/or early thelarche," Dr. Bronstein and his colleagues said.
No funding sources or financial conflicts of interest were reported.
FROM JOURNAL OF PEDIATRIC AND ADOLESCENT GYNECOLOGY
Major Finding: Preadolescent girls (aged 9-12) can develop PCOS, and physicians should suspect the disorder in girls with early-onset pubarche or thelarche as well as those with traditional risk factors including hyperinsulinemia and a family history of PCOS.
Data Source: A cross-sectional retrospective chart study of 58 females aged 9-18 years with PCOS.
Disclosures: No funding sources or financial conflicts of interest were reported.
Induced Abortion Not Associated With Later Psychiatric Problems
Undergoing induced abortion was not associated with the later development of psychiatric problems, according to a report in the Jan. 27 issue of the New England Journal of Medicine.
In a population-based cohort study of more than 365,000 Danish women who became pregnant between 1995 and 2007, the rate of first-time contact with a psychiatric caregiver was no different in the year following a first-trimester induced abortion than it was during the year preceding the abortion, said Trine Munk-Olsen, Ph.D., of the National Center for Register-Based Research at Aarhus University, Denmark, and her associates.
The investigators undertook this study because previous studies of the issue "have had methodologic limitations, including small and self-selected study samples, low response rates and high dropout rates during the follow-up period, lack of control for potential confounders, and inadequate measures of exposure and outcome variables," they noted.
Their study avoided these limitations by relying on national registry data. Induced abortions are legal in Denmark and are tracked in the national health care registry, as are inpatient and outpatient contacts at psychiatric facilities.
The study included 365,550 Danish women who had no history of mental disorders and who had either a first childbirth or a first-ever first-trimester induced abortion between 1995 and 2007.
Among the 84,620 of these subjects who had a first-trimester induced abortion, the rate of a first inpatient or outpatient psychiatric contact was 1.5% during the following year, which was not significantly different from the 1.0% rate during the 9 months preceding the procedure.
The incidences of psychiatric contacts were 14.6/1,000 person-years before the induced abortion and 15.2/1,000 person-years afterward, a nonsignificant difference, Dr. Munk-Olsen and her associates wrote (N. Engl. J. Med. 2011;364:332-9).
"We performed additional analyses to assess whether the results differed on the basis of the subgroup of mental disorders," but they did not, the researchers said. The findings refute the contention that "there is an overall increased risk of mental disorders after first-trimester induced abortion."
Of interest was another finding that, during the same interval, when 280,930 women gave birth to their first live-born child, the rate of first-time psychiatric contact rose significantly from 0.3% in the year before delivery to 0.7% in the year following delivery. The incidences of psychiatric contacts were 3.9/1,000 person-years before childbirth and a significantly higher 6.7/1,000 person-years after childbirth. Thus, childbirth is related to a significant increase in psychiatric consultations, while induced abortion is not.
Although the rate of psychiatric contact was higher among women who had induced abortions than among those who gave birth, those rates were similarly discrepant before the pregnancies occurred. "This suggests that any propensity toward mental health disorders in women who have induced abortions predates the abortion and indeed may make termination of the pregnancy more likely," Dr. Munk-Olsen and her colleagues said.
"This finding underscores the potential bias of direct comparisons of rates of mental health problems between women who have undergone abortion and those who have given birth," they noted.
One such study found a 30% relative increase in the rate of mental disorders among women having abortions, compared with women not having abortions. "However, the study was performed in New Zealand, where the majority of abortions are authorized on the basis of mental health indications. This restriction in the availability of abortions can introduce bias, since mental health problems observed after an abortion may reflect conditions and characteristics predating the abortion rather than resulting from the abortion," the investigators wrote.
This study was supported by grants from the Susan Thompson Buffett Foundation and the Danish Medical Research Council. One of Dr. Munk-Olsen’s associates reported ties to Bayer Schering Pharma.
Undergoing induced abortion was not associated with the later development of psychiatric problems, according to a report in the Jan. 27 issue of the New England Journal of Medicine.
In a population-based cohort study of more than 365,000 Danish women who became pregnant between 1995 and 2007, the rate of first-time contact with a psychiatric caregiver was no different in the year following a first-trimester induced abortion than it was during the year preceding the abortion, said Trine Munk-Olsen, Ph.D., of the National Center for Register-Based Research at Aarhus University, Denmark, and her associates.
The investigators undertook this study because previous studies of the issue "have had methodologic limitations, including small and self-selected study samples, low response rates and high dropout rates during the follow-up period, lack of control for potential confounders, and inadequate measures of exposure and outcome variables," they noted.
Their study avoided these limitations by relying on national registry data. Induced abortions are legal in Denmark and are tracked in the national health care registry, as are inpatient and outpatient contacts at psychiatric facilities.
The study included 365,550 Danish women who had no history of mental disorders and who had either a first childbirth or a first-ever first-trimester induced abortion between 1995 and 2007.
Among the 84,620 of these subjects who had a first-trimester induced abortion, the rate of a first inpatient or outpatient psychiatric contact was 1.5% during the following year, which was not significantly different from the 1.0% rate during the 9 months preceding the procedure.
The incidences of psychiatric contacts were 14.6/1,000 person-years before the induced abortion and 15.2/1,000 person-years afterward, a nonsignificant difference, Dr. Munk-Olsen and her associates wrote (N. Engl. J. Med. 2011;364:332-9).
"We performed additional analyses to assess whether the results differed on the basis of the subgroup of mental disorders," but they did not, the researchers said. The findings refute the contention that "there is an overall increased risk of mental disorders after first-trimester induced abortion."
Of interest was another finding that, during the same interval, when 280,930 women gave birth to their first live-born child, the rate of first-time psychiatric contact rose significantly from 0.3% in the year before delivery to 0.7% in the year following delivery. The incidences of psychiatric contacts were 3.9/1,000 person-years before childbirth and a significantly higher 6.7/1,000 person-years after childbirth. Thus, childbirth is related to a significant increase in psychiatric consultations, while induced abortion is not.
Although the rate of psychiatric contact was higher among women who had induced abortions than among those who gave birth, those rates were similarly discrepant before the pregnancies occurred. "This suggests that any propensity toward mental health disorders in women who have induced abortions predates the abortion and indeed may make termination of the pregnancy more likely," Dr. Munk-Olsen and her colleagues said.
"This finding underscores the potential bias of direct comparisons of rates of mental health problems between women who have undergone abortion and those who have given birth," they noted.
One such study found a 30% relative increase in the rate of mental disorders among women having abortions, compared with women not having abortions. "However, the study was performed in New Zealand, where the majority of abortions are authorized on the basis of mental health indications. This restriction in the availability of abortions can introduce bias, since mental health problems observed after an abortion may reflect conditions and characteristics predating the abortion rather than resulting from the abortion," the investigators wrote.
This study was supported by grants from the Susan Thompson Buffett Foundation and the Danish Medical Research Council. One of Dr. Munk-Olsen’s associates reported ties to Bayer Schering Pharma.
Undergoing induced abortion was not associated with the later development of psychiatric problems, according to a report in the Jan. 27 issue of the New England Journal of Medicine.
In a population-based cohort study of more than 365,000 Danish women who became pregnant between 1995 and 2007, the rate of first-time contact with a psychiatric caregiver was no different in the year following a first-trimester induced abortion than it was during the year preceding the abortion, said Trine Munk-Olsen, Ph.D., of the National Center for Register-Based Research at Aarhus University, Denmark, and her associates.
The investigators undertook this study because previous studies of the issue "have had methodologic limitations, including small and self-selected study samples, low response rates and high dropout rates during the follow-up period, lack of control for potential confounders, and inadequate measures of exposure and outcome variables," they noted.
Their study avoided these limitations by relying on national registry data. Induced abortions are legal in Denmark and are tracked in the national health care registry, as are inpatient and outpatient contacts at psychiatric facilities.
The study included 365,550 Danish women who had no history of mental disorders and who had either a first childbirth or a first-ever first-trimester induced abortion between 1995 and 2007.
Among the 84,620 of these subjects who had a first-trimester induced abortion, the rate of a first inpatient or outpatient psychiatric contact was 1.5% during the following year, which was not significantly different from the 1.0% rate during the 9 months preceding the procedure.
The incidences of psychiatric contacts were 14.6/1,000 person-years before the induced abortion and 15.2/1,000 person-years afterward, a nonsignificant difference, Dr. Munk-Olsen and her associates wrote (N. Engl. J. Med. 2011;364:332-9).
"We performed additional analyses to assess whether the results differed on the basis of the subgroup of mental disorders," but they did not, the researchers said. The findings refute the contention that "there is an overall increased risk of mental disorders after first-trimester induced abortion."
Of interest was another finding that, during the same interval, when 280,930 women gave birth to their first live-born child, the rate of first-time psychiatric contact rose significantly from 0.3% in the year before delivery to 0.7% in the year following delivery. The incidences of psychiatric contacts were 3.9/1,000 person-years before childbirth and a significantly higher 6.7/1,000 person-years after childbirth. Thus, childbirth is related to a significant increase in psychiatric consultations, while induced abortion is not.
Although the rate of psychiatric contact was higher among women who had induced abortions than among those who gave birth, those rates were similarly discrepant before the pregnancies occurred. "This suggests that any propensity toward mental health disorders in women who have induced abortions predates the abortion and indeed may make termination of the pregnancy more likely," Dr. Munk-Olsen and her colleagues said.
"This finding underscores the potential bias of direct comparisons of rates of mental health problems between women who have undergone abortion and those who have given birth," they noted.
One such study found a 30% relative increase in the rate of mental disorders among women having abortions, compared with women not having abortions. "However, the study was performed in New Zealand, where the majority of abortions are authorized on the basis of mental health indications. This restriction in the availability of abortions can introduce bias, since mental health problems observed after an abortion may reflect conditions and characteristics predating the abortion rather than resulting from the abortion," the investigators wrote.
This study was supported by grants from the Susan Thompson Buffett Foundation and the Danish Medical Research Council. One of Dr. Munk-Olsen’s associates reported ties to Bayer Schering Pharma.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Major Finding: The rates of inpatient or outpatient contact with a psychiatric caregiver were not significantly different in the year after an induced abortion (1.5%) than they had been the year before the procedure (1.0%).
Data Source: A population-based cohort study of 365,000 Danish women who underwent either childbirth or a first-time first-trimester induced abortion between 1995 and 2007.
Disclosures: This study was supported by the Susan Thompson Buffett Foundation and the Danish Medical Research Council. Dr. Munk-Olsen’s associated reported ties to Bayer Schering Pharma.
Herpes Zoster Vaccine Found Effective in Real-World Practice
The herpes zoster vaccine reduced the incidence of the disease by 55% in real-world clinical practice, according to a report in the Jan. 12 issue of JAMA.
This finding, from a retrospective cohort study involving more than 303,000 healthy, community-dwelling adults aged 60 and older from diverse backgrounds, confirms and extends the results of clinical trials that found the vaccine effective under idealized conditions. In addition, the cohort study found further benefits that had not been shown before: The herpes zoster vaccine also decreased the rate of ophthalmic herpes, and it was effective in patients with underlying chronic diseases that were feared to interfere with their immune function.
Thus, the benefits of the herpes zoster vaccine extend to the ophthalmic manifestation of the disease, to all races, both genders, and all ages over 60, as well as to patients with chronic illness, said Hung Fu Tseng, Ph.D., of Southern California Kaiser Permanente, Pasadena, and associates.
These results are particularly important given that the public’s acceptance of the vaccine has been slow and it is not yet in widespread use. "This vaccine has the potential to annually prevent tens of thousands of cases of herpes zoster and postherpetic neuralgia nationally. To date, herpes zoster vaccine uptake has been poor due to weaknesses in the adult vaccine infrastructure and also due to serious barriers to the vaccine among clinicians and patients.
"Solutions to these challenges need to be found so that individuals seeking to receive herpes zoster vaccine will be able to reduce their risk of experiencing this serious condition," Dr. Tseng and his colleagues wrote.
They assessed the vaccine\'s effectiveness in 75,761 California patients in the managed care plan who were immunized in 2007-2009, comparing outcomes with those of 227,283 age-matched control subjects who were not vaccinated. A total of 5,434 cases of herpes zoster developed during an average follow-up of 1-2 years.
The incidence of herpes zoster was 6.4 per 1,000 person-years in the vaccinated group, compared with 13 per 1,000 patient-years in the control group. This reflects a 55% reduction in incidence with the vaccine, the investigators wrote (JAMA 2011;305:160-6).
This result indicates that "1 episode of herpes zoster would be averted for every 71 patients receiving the vaccine," they wrote.
The vaccine benefit persisted across all subgroups of patients, particularly in the oldest subjects. "Our results support recommendations to offer herpes zoster vaccine to eligible patients of all ages, including the oldest population," Dr. Tseng and his associates wrote.
"For the oldest group, this could translate into a very large absolute reduction in disease because they bear the greatest burden of herpes zoster and postherpetic neuralgia and are also especially vulnerable to these disabling conditions," the researchers added.
The vaccine’s effectiveness against ophthalmic herpes is an important finding not reported previously. Ophthalmic involvement is common and can lead to serious vision-threatening sequelae, they noted.
The finding that the vaccine also was effective in patients with chronic underlying disease was "reassuring," because "these diseases might have interfered with functional immunity and vaccine effectiveness. Control of pain from herpes zoster and postherpetic neuralgia is complicated in these patients because of their underlying conditions and the medications they must take," Dr. Tseng and his colleagues said.
The study was limited in that it involved only fully insured patients in a single region of the country, so "the results need to be generalized carefully." In addition, with its short follow-up, the study "was not designed to capture any decline in protection that is likely to occur with time," they added.
Dr. Tseng and three associates reported receiving research funding from Merck for other vaccine studies.
ophthalmic herpes, Dr. Hung Fu Tseng, Ph.D., postherpetic neuralgia
The herpes zoster vaccine reduced the incidence of the disease by 55% in real-world clinical practice, according to a report in the Jan. 12 issue of JAMA.
This finding, from a retrospective cohort study involving more than 303,000 healthy, community-dwelling adults aged 60 and older from diverse backgrounds, confirms and extends the results of clinical trials that found the vaccine effective under idealized conditions. In addition, the cohort study found further benefits that had not been shown before: The herpes zoster vaccine also decreased the rate of ophthalmic herpes, and it was effective in patients with underlying chronic diseases that were feared to interfere with their immune function.
Thus, the benefits of the herpes zoster vaccine extend to the ophthalmic manifestation of the disease, to all races, both genders, and all ages over 60, as well as to patients with chronic illness, said Hung Fu Tseng, Ph.D., of Southern California Kaiser Permanente, Pasadena, and associates.
These results are particularly important given that the public’s acceptance of the vaccine has been slow and it is not yet in widespread use. "This vaccine has the potential to annually prevent tens of thousands of cases of herpes zoster and postherpetic neuralgia nationally. To date, herpes zoster vaccine uptake has been poor due to weaknesses in the adult vaccine infrastructure and also due to serious barriers to the vaccine among clinicians and patients.
"Solutions to these challenges need to be found so that individuals seeking to receive herpes zoster vaccine will be able to reduce their risk of experiencing this serious condition," Dr. Tseng and his colleagues wrote.
They assessed the vaccine\'s effectiveness in 75,761 California patients in the managed care plan who were immunized in 2007-2009, comparing outcomes with those of 227,283 age-matched control subjects who were not vaccinated. A total of 5,434 cases of herpes zoster developed during an average follow-up of 1-2 years.
The incidence of herpes zoster was 6.4 per 1,000 person-years in the vaccinated group, compared with 13 per 1,000 patient-years in the control group. This reflects a 55% reduction in incidence with the vaccine, the investigators wrote (JAMA 2011;305:160-6).
This result indicates that "1 episode of herpes zoster would be averted for every 71 patients receiving the vaccine," they wrote.
The vaccine benefit persisted across all subgroups of patients, particularly in the oldest subjects. "Our results support recommendations to offer herpes zoster vaccine to eligible patients of all ages, including the oldest population," Dr. Tseng and his associates wrote.
"For the oldest group, this could translate into a very large absolute reduction in disease because they bear the greatest burden of herpes zoster and postherpetic neuralgia and are also especially vulnerable to these disabling conditions," the researchers added.
The vaccine’s effectiveness against ophthalmic herpes is an important finding not reported previously. Ophthalmic involvement is common and can lead to serious vision-threatening sequelae, they noted.
The finding that the vaccine also was effective in patients with chronic underlying disease was "reassuring," because "these diseases might have interfered with functional immunity and vaccine effectiveness. Control of pain from herpes zoster and postherpetic neuralgia is complicated in these patients because of their underlying conditions and the medications they must take," Dr. Tseng and his colleagues said.
The study was limited in that it involved only fully insured patients in a single region of the country, so "the results need to be generalized carefully." In addition, with its short follow-up, the study "was not designed to capture any decline in protection that is likely to occur with time," they added.
Dr. Tseng and three associates reported receiving research funding from Merck for other vaccine studies.
The herpes zoster vaccine reduced the incidence of the disease by 55% in real-world clinical practice, according to a report in the Jan. 12 issue of JAMA.
This finding, from a retrospective cohort study involving more than 303,000 healthy, community-dwelling adults aged 60 and older from diverse backgrounds, confirms and extends the results of clinical trials that found the vaccine effective under idealized conditions. In addition, the cohort study found further benefits that had not been shown before: The herpes zoster vaccine also decreased the rate of ophthalmic herpes, and it was effective in patients with underlying chronic diseases that were feared to interfere with their immune function.
Thus, the benefits of the herpes zoster vaccine extend to the ophthalmic manifestation of the disease, to all races, both genders, and all ages over 60, as well as to patients with chronic illness, said Hung Fu Tseng, Ph.D., of Southern California Kaiser Permanente, Pasadena, and associates.
These results are particularly important given that the public’s acceptance of the vaccine has been slow and it is not yet in widespread use. "This vaccine has the potential to annually prevent tens of thousands of cases of herpes zoster and postherpetic neuralgia nationally. To date, herpes zoster vaccine uptake has been poor due to weaknesses in the adult vaccine infrastructure and also due to serious barriers to the vaccine among clinicians and patients.
"Solutions to these challenges need to be found so that individuals seeking to receive herpes zoster vaccine will be able to reduce their risk of experiencing this serious condition," Dr. Tseng and his colleagues wrote.
They assessed the vaccine\'s effectiveness in 75,761 California patients in the managed care plan who were immunized in 2007-2009, comparing outcomes with those of 227,283 age-matched control subjects who were not vaccinated. A total of 5,434 cases of herpes zoster developed during an average follow-up of 1-2 years.
The incidence of herpes zoster was 6.4 per 1,000 person-years in the vaccinated group, compared with 13 per 1,000 patient-years in the control group. This reflects a 55% reduction in incidence with the vaccine, the investigators wrote (JAMA 2011;305:160-6).
This result indicates that "1 episode of herpes zoster would be averted for every 71 patients receiving the vaccine," they wrote.
The vaccine benefit persisted across all subgroups of patients, particularly in the oldest subjects. "Our results support recommendations to offer herpes zoster vaccine to eligible patients of all ages, including the oldest population," Dr. Tseng and his associates wrote.
"For the oldest group, this could translate into a very large absolute reduction in disease because they bear the greatest burden of herpes zoster and postherpetic neuralgia and are also especially vulnerable to these disabling conditions," the researchers added.
The vaccine’s effectiveness against ophthalmic herpes is an important finding not reported previously. Ophthalmic involvement is common and can lead to serious vision-threatening sequelae, they noted.
The finding that the vaccine also was effective in patients with chronic underlying disease was "reassuring," because "these diseases might have interfered with functional immunity and vaccine effectiveness. Control of pain from herpes zoster and postherpetic neuralgia is complicated in these patients because of their underlying conditions and the medications they must take," Dr. Tseng and his colleagues said.
The study was limited in that it involved only fully insured patients in a single region of the country, so "the results need to be generalized carefully." In addition, with its short follow-up, the study "was not designed to capture any decline in protection that is likely to occur with time," they added.
Dr. Tseng and three associates reported receiving research funding from Merck for other vaccine studies.
ophthalmic herpes, Dr. Hung Fu Tseng, Ph.D., postherpetic neuralgia
ophthalmic herpes, Dr. Hung Fu Tseng, Ph.D., postherpetic neuralgia
FROM JAMA
Major Finding: The herpes zoster vaccine decreased the incidence of herpes zoster by 55% in healthy older patients, and decreased the incidence of ophthalmic herpes zoster. The vaccine’s benefits were consistent across all ethnic groups, all ages over 60, both sexes, and in patients with chronic disease.
Data Source: An observational retrospective cohort study involving more than 75,000 Californians aged 60 and older who received the herpes zoster vaccine and more than 227,000 who did not, with 1-2 years of follow-up.
Disclosures: Dr. Tseng and three associates reported receiving research funding from Merck for other vaccine studies.
New Guidelines on Carotid Disease Advise Against Routine Screening
New guidelines for managing extracranial carotid and vertebral artery disease recommend against routine screening for obstruction, and advocate ultrasound examination only in patients who are symptomatic or have at least risk two factors for stroke.
The guidelines also state that based on current evidence, carotid endarterectomy and carotid stenting appear to be equally "reasonable and safe" for patients found to have more than 50% blockage, with the choice between the two approaches dictated by individual factors such as patient anatomy, comorbidities, and stroke risk, wrote cochairs Dr. Jonathan L. Halperin, professor of medicine at Mount Sinai School of Medicine, New York, and Dr. Thomas G. Brott, professor of neurology and director of research at the Mayo Clinic, Jacksonville, Fla., and their colleagues on the writing committee.
The new guidelines, issued jointly by the American Heart Association, American Stroke Association, American College of Cardiology, and other expert groups, "are intended to assist the diverse array of clinicians who provide care for patients with ECVD [extracranial carotid and vertebral artery disease]" and include a comprehensive review of the most recent literature. They detail dozens of recommendations for diagnostic testing, treatment of contributing factors such as hypertension and hyperlipidemia, selecting patients for carotid revascularization, managing restenosis, and handling anatomic abnormalities and special patient populations (J. Am. Coll. Cardiol. 2011 [doi.10.1016/j.jacc.2010.11005]).
Among these recommendations:
• Duplex ultrasonography is the initial diagnostic test of choice for detecting hemodynamically significant carotid stenosis. It is "reasonable" to use this technique in asymptomatic patients if they have a carotid bruit; symptomatic coronary artery disease, peripheral artery disease, or atherosclerotic aortic aneurysm; or at least two of the following risk factors: hypertension, hyperlipidemia, smoking, family history of atherosclerosis manifested before age 60, and family history of ischemic stroke.
• Carotid stenting and carotid endarterectomy are similarly safe for treating obstructions of 50% or more. Physicians and patients should decide between the two procedures on an individual basis, taking into account surgical risk, comorbidities, life expectancy, patient preferences, neck anatomy, and other factors.
• "The value of specific therapies to prevent stroke, even in symptomatic patients with severe carotid artery stenosis, largely lacks validation." Antiplatelet therapy reduces stroke risk in patients with transient ischemic attack or previous stroke, but "no adequately powered studies have demonstrated their efficacy for stroke prevention in asymptomatic patients with ECVD." Similarly, the use of anticoagulants in ECVD patients who develop stroke has not been explored.
• It remains unclear whether women benefit as much as men do from carotid endarterectomy. Information also is lacking for other important subsets of patients, including the elderly and various racial/ethnic groups.
• "The most pressing question is how either technique of revascularization compares with intensive contemporary medical therapy, particularly among asymptomatic patients." A clinical trial that directly compares the three approaches "should include a sufficiently broad range of patients to permit meaningful analysis of subgroups based on age, sex, ethnicity, and risk status."
Regarding vertebral artery disease, the guidelines state that its infrequency relative to carotid artery disease has made for "huge gaps in knowledge." Registries to capture data on the prevalence, pathophysiology, prognosis, and natural history of vertebral artery disease would be an important first step in addressing these gaps, the authors noted.
The executive summary and the full guidelines are available at www.cardiosource.org and my.americanheart.org and are being co-published in Circulation, Catheterization and Cardiovascular Interventions, the Journal of Cardiovascular Computed Tomography, the Journal of NeuroInterventional Surgery, the Journal of Vascular Surgery, and Vascular Medicine.
Most of the members of the writing committee disclosed ties to pharmaceutical and/or device companies. A complete list of those relations, and those of the peer reviewers, is in the executive summary.
carotid endarterectomy, carotid stenting, Dr. Jonathan L. Halperin, Dr. Thomas G. Brott, the American Heart Association, American Stroke Association, American College of Cardiology, ECVD,
New guidelines for managing extracranial carotid and vertebral artery disease recommend against routine screening for obstruction, and advocate ultrasound examination only in patients who are symptomatic or have at least risk two factors for stroke.
The guidelines also state that based on current evidence, carotid endarterectomy and carotid stenting appear to be equally "reasonable and safe" for patients found to have more than 50% blockage, with the choice between the two approaches dictated by individual factors such as patient anatomy, comorbidities, and stroke risk, wrote cochairs Dr. Jonathan L. Halperin, professor of medicine at Mount Sinai School of Medicine, New York, and Dr. Thomas G. Brott, professor of neurology and director of research at the Mayo Clinic, Jacksonville, Fla., and their colleagues on the writing committee.
The new guidelines, issued jointly by the American Heart Association, American Stroke Association, American College of Cardiology, and other expert groups, "are intended to assist the diverse array of clinicians who provide care for patients with ECVD [extracranial carotid and vertebral artery disease]" and include a comprehensive review of the most recent literature. They detail dozens of recommendations for diagnostic testing, treatment of contributing factors such as hypertension and hyperlipidemia, selecting patients for carotid revascularization, managing restenosis, and handling anatomic abnormalities and special patient populations (J. Am. Coll. Cardiol. 2011 [doi.10.1016/j.jacc.2010.11005]).
Among these recommendations:
• Duplex ultrasonography is the initial diagnostic test of choice for detecting hemodynamically significant carotid stenosis. It is "reasonable" to use this technique in asymptomatic patients if they have a carotid bruit; symptomatic coronary artery disease, peripheral artery disease, or atherosclerotic aortic aneurysm; or at least two of the following risk factors: hypertension, hyperlipidemia, smoking, family history of atherosclerosis manifested before age 60, and family history of ischemic stroke.
• Carotid stenting and carotid endarterectomy are similarly safe for treating obstructions of 50% or more. Physicians and patients should decide between the two procedures on an individual basis, taking into account surgical risk, comorbidities, life expectancy, patient preferences, neck anatomy, and other factors.
• "The value of specific therapies to prevent stroke, even in symptomatic patients with severe carotid artery stenosis, largely lacks validation." Antiplatelet therapy reduces stroke risk in patients with transient ischemic attack or previous stroke, but "no adequately powered studies have demonstrated their efficacy for stroke prevention in asymptomatic patients with ECVD." Similarly, the use of anticoagulants in ECVD patients who develop stroke has not been explored.
• It remains unclear whether women benefit as much as men do from carotid endarterectomy. Information also is lacking for other important subsets of patients, including the elderly and various racial/ethnic groups.
• "The most pressing question is how either technique of revascularization compares with intensive contemporary medical therapy, particularly among asymptomatic patients." A clinical trial that directly compares the three approaches "should include a sufficiently broad range of patients to permit meaningful analysis of subgroups based on age, sex, ethnicity, and risk status."
Regarding vertebral artery disease, the guidelines state that its infrequency relative to carotid artery disease has made for "huge gaps in knowledge." Registries to capture data on the prevalence, pathophysiology, prognosis, and natural history of vertebral artery disease would be an important first step in addressing these gaps, the authors noted.
The executive summary and the full guidelines are available at www.cardiosource.org and my.americanheart.org and are being co-published in Circulation, Catheterization and Cardiovascular Interventions, the Journal of Cardiovascular Computed Tomography, the Journal of NeuroInterventional Surgery, the Journal of Vascular Surgery, and Vascular Medicine.
Most of the members of the writing committee disclosed ties to pharmaceutical and/or device companies. A complete list of those relations, and those of the peer reviewers, is in the executive summary.
New guidelines for managing extracranial carotid and vertebral artery disease recommend against routine screening for obstruction, and advocate ultrasound examination only in patients who are symptomatic or have at least risk two factors for stroke.
The guidelines also state that based on current evidence, carotid endarterectomy and carotid stenting appear to be equally "reasonable and safe" for patients found to have more than 50% blockage, with the choice between the two approaches dictated by individual factors such as patient anatomy, comorbidities, and stroke risk, wrote cochairs Dr. Jonathan L. Halperin, professor of medicine at Mount Sinai School of Medicine, New York, and Dr. Thomas G. Brott, professor of neurology and director of research at the Mayo Clinic, Jacksonville, Fla., and their colleagues on the writing committee.
The new guidelines, issued jointly by the American Heart Association, American Stroke Association, American College of Cardiology, and other expert groups, "are intended to assist the diverse array of clinicians who provide care for patients with ECVD [extracranial carotid and vertebral artery disease]" and include a comprehensive review of the most recent literature. They detail dozens of recommendations for diagnostic testing, treatment of contributing factors such as hypertension and hyperlipidemia, selecting patients for carotid revascularization, managing restenosis, and handling anatomic abnormalities and special patient populations (J. Am. Coll. Cardiol. 2011 [doi.10.1016/j.jacc.2010.11005]).
Among these recommendations:
• Duplex ultrasonography is the initial diagnostic test of choice for detecting hemodynamically significant carotid stenosis. It is "reasonable" to use this technique in asymptomatic patients if they have a carotid bruit; symptomatic coronary artery disease, peripheral artery disease, or atherosclerotic aortic aneurysm; or at least two of the following risk factors: hypertension, hyperlipidemia, smoking, family history of atherosclerosis manifested before age 60, and family history of ischemic stroke.
• Carotid stenting and carotid endarterectomy are similarly safe for treating obstructions of 50% or more. Physicians and patients should decide between the two procedures on an individual basis, taking into account surgical risk, comorbidities, life expectancy, patient preferences, neck anatomy, and other factors.
• "The value of specific therapies to prevent stroke, even in symptomatic patients with severe carotid artery stenosis, largely lacks validation." Antiplatelet therapy reduces stroke risk in patients with transient ischemic attack or previous stroke, but "no adequately powered studies have demonstrated their efficacy for stroke prevention in asymptomatic patients with ECVD." Similarly, the use of anticoagulants in ECVD patients who develop stroke has not been explored.
• It remains unclear whether women benefit as much as men do from carotid endarterectomy. Information also is lacking for other important subsets of patients, including the elderly and various racial/ethnic groups.
• "The most pressing question is how either technique of revascularization compares with intensive contemporary medical therapy, particularly among asymptomatic patients." A clinical trial that directly compares the three approaches "should include a sufficiently broad range of patients to permit meaningful analysis of subgroups based on age, sex, ethnicity, and risk status."
Regarding vertebral artery disease, the guidelines state that its infrequency relative to carotid artery disease has made for "huge gaps in knowledge." Registries to capture data on the prevalence, pathophysiology, prognosis, and natural history of vertebral artery disease would be an important first step in addressing these gaps, the authors noted.
The executive summary and the full guidelines are available at www.cardiosource.org and my.americanheart.org and are being co-published in Circulation, Catheterization and Cardiovascular Interventions, the Journal of Cardiovascular Computed Tomography, the Journal of NeuroInterventional Surgery, the Journal of Vascular Surgery, and Vascular Medicine.
Most of the members of the writing committee disclosed ties to pharmaceutical and/or device companies. A complete list of those relations, and those of the peer reviewers, is in the executive summary.
carotid endarterectomy, carotid stenting, Dr. Jonathan L. Halperin, Dr. Thomas G. Brott, the American Heart Association, American Stroke Association, American College of Cardiology, ECVD,
carotid endarterectomy, carotid stenting, Dr. Jonathan L. Halperin, Dr. Thomas G. Brott, the American Heart Association, American Stroke Association, American College of Cardiology, ECVD,
Diabetes, Depression Show Bidirectional Link in Middle-Age Women
The association between diabetes and depression is bidirectional in middle-age women, with the presence of either disease significantly raising the risk that the other also will develop, according to a report in the Archives of Internal Medicine.
Moreover, diabetes raises the risk of depression, and depression raises the risk of diabetes, independently of other known risk factors such as adiposity that are common to both diseases, said An Pan, Ph.D., of Harvard School of Public Health, Boston, and his associates.
To date, "only a few" studies have examined the association between diabetes and depression simultaneously, and their results have been inconsistent. "Therefore, we took advantage of repeated measurements of lifestyle risk factors and disease occurrences during 10 years of follow-up in a large prospective cohort" – the Nurses’ Health Study – to address the bidirectional relationship.
The NHS involved female registered nurses residing in 11 states who were followed every 2 years via health questionnaires. Dr. Pan and his colleagues assessed a subset of 65,381 NHS participants who were aged 50-75 years in 1996 and were followed until 2006.
Depressive symptoms were categorized according to the women’s scores on the Mental Health Index 5, whether depression had been diagnosed by a physician and whether they used antidepressants. Diabetes was categorized as requiring no medications, only oral hypoglycemic agents, or insulin therapy.
During follow-up, 2,844 incident cases of diabetes were documented. The risk of developing diabetes was significantly higher in women who had depressive symptoms than in those who did not.
In addition, this rise in diabetes risk showed a "dose-response relationship" with worsening depressive symptoms, such that diabetes risk increased significantly as scores on the MHI-5 rose.
This association between depression and diabetes remained significant, although it was markedly attenuated, when the data were adjusted to account for body mass index (BMI) and lifestyle factors, particularly physical activity.
In a separate analysis of the same data, 7,415 study subjects developed incident clinical depression during follow-up. Compared with women who did not have diabetes, women with diabetes had a relative risk of developing clinical depression of 1.44, the investigators said (Arch. Intern. Med. 2010;170:1884-91).
Controlling for major comorbidities such as hypertension and coronary heart disease attenuated this association, but it remained significant.
In addition, the risk of developing clinical depression also showed a dose-response relationship with worsening diabetes symptoms. Women with diabetes who were not taking any medication had a relative risk of 1.36; those taking oral agents only had a relative risk of 1.42; and those taking insulin had a relative risk of 1.78 of developing clinical depression.
These findings show that depression and diabetes "are closely related to each other, and this reciprocal association also depends on the severity and treatment of each condition. All the associations were independent of sociodemographic, diet, and lifestyle factors," Dr. Pan and his associates said.
Since depression and diabetes both are highly prevalent in the middle-age and elderly populations, particularly among women, "proper lifestyle interventions including adequate weight management and regular physical activity are recommended to lower the risk of both conditions," they noted.
The reasons underlying the bidirectional association are not yet understood. It is possible that antidepressant use might be a contributing factor to diabetes risk. Antidepressants might exert some clinical effects on glucose homeostasis, and they are known to cause weight gain. However, the link between depression and diabetes was significant independent of BMI, so the possibility that antidepressants might exert some other metabolic effect warrants further investigation, the researchers said.
Alternatively, biochemical changes directly caused by diabetes or its treatment might contribute to depression. It also is possible that the stresses associated with chronic diabetes and its debilitating consequences also contribute to depression.
This study was somewhat limited in that the NHS cohort was 94% white, well educated, and well versed on health issues. The results might not be generalizable to other populations, they added.
This study was supported by the National Institutes of Health, the National Alliance for Research on Schizophrenia & Depression, and the Fonds de la recherche en santé du Québec. No financial conflicts of interest were reported.
The association between diabetes and depression is bidirectional in middle-age women, with the presence of either disease significantly raising the risk that the other also will develop, according to a report in the Archives of Internal Medicine.
Moreover, diabetes raises the risk of depression, and depression raises the risk of diabetes, independently of other known risk factors such as adiposity that are common to both diseases, said An Pan, Ph.D., of Harvard School of Public Health, Boston, and his associates.
To date, "only a few" studies have examined the association between diabetes and depression simultaneously, and their results have been inconsistent. "Therefore, we took advantage of repeated measurements of lifestyle risk factors and disease occurrences during 10 years of follow-up in a large prospective cohort" – the Nurses’ Health Study – to address the bidirectional relationship.
The NHS involved female registered nurses residing in 11 states who were followed every 2 years via health questionnaires. Dr. Pan and his colleagues assessed a subset of 65,381 NHS participants who were aged 50-75 years in 1996 and were followed until 2006.
Depressive symptoms were categorized according to the women’s scores on the Mental Health Index 5, whether depression had been diagnosed by a physician and whether they used antidepressants. Diabetes was categorized as requiring no medications, only oral hypoglycemic agents, or insulin therapy.
During follow-up, 2,844 incident cases of diabetes were documented. The risk of developing diabetes was significantly higher in women who had depressive symptoms than in those who did not.
In addition, this rise in diabetes risk showed a "dose-response relationship" with worsening depressive symptoms, such that diabetes risk increased significantly as scores on the MHI-5 rose.
This association between depression and diabetes remained significant, although it was markedly attenuated, when the data were adjusted to account for body mass index (BMI) and lifestyle factors, particularly physical activity.
In a separate analysis of the same data, 7,415 study subjects developed incident clinical depression during follow-up. Compared with women who did not have diabetes, women with diabetes had a relative risk of developing clinical depression of 1.44, the investigators said (Arch. Intern. Med. 2010;170:1884-91).
Controlling for major comorbidities such as hypertension and coronary heart disease attenuated this association, but it remained significant.
In addition, the risk of developing clinical depression also showed a dose-response relationship with worsening diabetes symptoms. Women with diabetes who were not taking any medication had a relative risk of 1.36; those taking oral agents only had a relative risk of 1.42; and those taking insulin had a relative risk of 1.78 of developing clinical depression.
These findings show that depression and diabetes "are closely related to each other, and this reciprocal association also depends on the severity and treatment of each condition. All the associations were independent of sociodemographic, diet, and lifestyle factors," Dr. Pan and his associates said.
Since depression and diabetes both are highly prevalent in the middle-age and elderly populations, particularly among women, "proper lifestyle interventions including adequate weight management and regular physical activity are recommended to lower the risk of both conditions," they noted.
The reasons underlying the bidirectional association are not yet understood. It is possible that antidepressant use might be a contributing factor to diabetes risk. Antidepressants might exert some clinical effects on glucose homeostasis, and they are known to cause weight gain. However, the link between depression and diabetes was significant independent of BMI, so the possibility that antidepressants might exert some other metabolic effect warrants further investigation, the researchers said.
Alternatively, biochemical changes directly caused by diabetes or its treatment might contribute to depression. It also is possible that the stresses associated with chronic diabetes and its debilitating consequences also contribute to depression.
This study was somewhat limited in that the NHS cohort was 94% white, well educated, and well versed on health issues. The results might not be generalizable to other populations, they added.
This study was supported by the National Institutes of Health, the National Alliance for Research on Schizophrenia & Depression, and the Fonds de la recherche en santé du Québec. No financial conflicts of interest were reported.
The association between diabetes and depression is bidirectional in middle-age women, with the presence of either disease significantly raising the risk that the other also will develop, according to a report in the Archives of Internal Medicine.
Moreover, diabetes raises the risk of depression, and depression raises the risk of diabetes, independently of other known risk factors such as adiposity that are common to both diseases, said An Pan, Ph.D., of Harvard School of Public Health, Boston, and his associates.
To date, "only a few" studies have examined the association between diabetes and depression simultaneously, and their results have been inconsistent. "Therefore, we took advantage of repeated measurements of lifestyle risk factors and disease occurrences during 10 years of follow-up in a large prospective cohort" – the Nurses’ Health Study – to address the bidirectional relationship.
The NHS involved female registered nurses residing in 11 states who were followed every 2 years via health questionnaires. Dr. Pan and his colleagues assessed a subset of 65,381 NHS participants who were aged 50-75 years in 1996 and were followed until 2006.
Depressive symptoms were categorized according to the women’s scores on the Mental Health Index 5, whether depression had been diagnosed by a physician and whether they used antidepressants. Diabetes was categorized as requiring no medications, only oral hypoglycemic agents, or insulin therapy.
During follow-up, 2,844 incident cases of diabetes were documented. The risk of developing diabetes was significantly higher in women who had depressive symptoms than in those who did not.
In addition, this rise in diabetes risk showed a "dose-response relationship" with worsening depressive symptoms, such that diabetes risk increased significantly as scores on the MHI-5 rose.
This association between depression and diabetes remained significant, although it was markedly attenuated, when the data were adjusted to account for body mass index (BMI) and lifestyle factors, particularly physical activity.
In a separate analysis of the same data, 7,415 study subjects developed incident clinical depression during follow-up. Compared with women who did not have diabetes, women with diabetes had a relative risk of developing clinical depression of 1.44, the investigators said (Arch. Intern. Med. 2010;170:1884-91).
Controlling for major comorbidities such as hypertension and coronary heart disease attenuated this association, but it remained significant.
In addition, the risk of developing clinical depression also showed a dose-response relationship with worsening diabetes symptoms. Women with diabetes who were not taking any medication had a relative risk of 1.36; those taking oral agents only had a relative risk of 1.42; and those taking insulin had a relative risk of 1.78 of developing clinical depression.
These findings show that depression and diabetes "are closely related to each other, and this reciprocal association also depends on the severity and treatment of each condition. All the associations were independent of sociodemographic, diet, and lifestyle factors," Dr. Pan and his associates said.
Since depression and diabetes both are highly prevalent in the middle-age and elderly populations, particularly among women, "proper lifestyle interventions including adequate weight management and regular physical activity are recommended to lower the risk of both conditions," they noted.
The reasons underlying the bidirectional association are not yet understood. It is possible that antidepressant use might be a contributing factor to diabetes risk. Antidepressants might exert some clinical effects on glucose homeostasis, and they are known to cause weight gain. However, the link between depression and diabetes was significant independent of BMI, so the possibility that antidepressants might exert some other metabolic effect warrants further investigation, the researchers said.
Alternatively, biochemical changes directly caused by diabetes or its treatment might contribute to depression. It also is possible that the stresses associated with chronic diabetes and its debilitating consequences also contribute to depression.
This study was somewhat limited in that the NHS cohort was 94% white, well educated, and well versed on health issues. The results might not be generalizable to other populations, they added.
This study was supported by the National Institutes of Health, the National Alliance for Research on Schizophrenia & Depression, and the Fonds de la recherche en santé du Québec. No financial conflicts of interest were reported.
FROM THE ARCHIVES OF INTERNAL MEDICINE
Major Finding: The risk of developing diabetes was higher in women with depressive symptoms than in those without such symptoms, and severity of diabetes increased as severity of depression increased. Similarly, the risk of developing depression was higher in women with diabetes than in nondiabetics, and that risk also increased as the severity of diabetes increased.
Data Source: A secondary analysis of data from over 65,000 subjects in the Nurses’ Health Study, a prospective cohort study of middle-age American women followed via questionnaire biannually for 10 years.
Disclosures: This study was supported by the National Institutes of Health, the National Alliance for Research on Schizophrenia & Depression, and the Fonds de recherche en santé du Québec. No financial conflicts of interest were reported.
Obesity is Only Lifestyle Factor Found to Influence Risk for Glaucoma
Only one lifestyle factor – obesity – was found to influence a patient’s risk for open-angle glaucoma, and it exerted a protective effect in women only, according to a study published Feb. 14 in the Archives of Ophthalmology.
Patient education level, income, smoking status, and alcohol intake all had no association with risk for developing glaucoma, and obesity had no association with glaucoma risk among men, said Dr. Wishal D. Ramdas of the departments of epidemiology and ophthalmology at Erasmus Medical center, Rotterdam, The Netherlands, and associates.
Previous studies of glaucoma risk have yielded conflicting results regarding lifestyle factors. Conclusions about smoking and alcohol intake in particular have been very mixed. Dr. Ramdas and colleagues examined the issue using data from the Rotterdam Study, a prospective population-based cohort study of eye disorders among Netherlands residents who were aged 55 and older when first assessed in 1991-93 and who were followed up in 1997-99 as well as in 2002-2006.
The study subjects’ eyes were examined using autorefraction, keratometry, measurement of visual acuity, tonometry, fundus photography, tomographic imaging, and visual field testing.
For this study, a subset of 3,939 subjects who were free of glaucoma at baseline and were followed for a mean of 10 years were assessed. A total of 108 (2.7%) developed glaucoma during that time.
Overall, the only difference in lifestyle factors between subjects who developed glaucoma and subjects who did not was obesity. Subjects who developed glaucoma had a significantly lower body mass index than did those who did not.
Further analysis showed that this association was present only among women. In women, each unit increase in BMI was associated with a 7% reduction in the risk of developing glaucoma, the investigators said (Arch. Ophthalmol. 2011 Feb. 14 [doi:10.1001/archophthalmol.2010.373]).
There also was no association between glaucoma risk and alcohol intake when the data were broken down according to the percentage of alcohol in various drinks. Subjects who drank beverages with a comparatively low alcohol content (such as beer and wine) showed the same risk of developing glaucoma as did subjects who drank beverages with a moderate alcohol content (such as port wine or sherry) or the strongest alcohol content (such as hard liquor).
The study had one paradoxical finding: BMI was inversely related to intraocular pressure. Higher BMI raised the risk of higher intraocular pressure, which in turn should have raised rather than lowered the risk of developing glaucoma among women.
The reason for this contradiction is not yet known, but given the discrepant results between men and women, it may be related to estrogen levels. Body fat has estrogenic effects, so it’s possible that higher BMI raises intraocular pressure but these estrogenic effects protect against glaucoma, Dr. Ramdas and associates wrote.
They also suggested that the protective effect could be related to an instrument used in the study: “An explanation for this finding is that, with Goldmann applanation tonometry, the thorax and abdomen are pushed against the slitlamp table while breath holding works like a Valsalva maneuver” especially for obese women. This could lead to an overestimation of IOP which may have contributed to this inverse association, they wrote.
Only one lifestyle factor – obesity – was found to influence a patient’s risk for open-angle glaucoma, and it exerted a protective effect in women only, according to a study published Feb. 14 in the Archives of Ophthalmology.
Patient education level, income, smoking status, and alcohol intake all had no association with risk for developing glaucoma, and obesity had no association with glaucoma risk among men, said Dr. Wishal D. Ramdas of the departments of epidemiology and ophthalmology at Erasmus Medical center, Rotterdam, The Netherlands, and associates.
Previous studies of glaucoma risk have yielded conflicting results regarding lifestyle factors. Conclusions about smoking and alcohol intake in particular have been very mixed. Dr. Ramdas and colleagues examined the issue using data from the Rotterdam Study, a prospective population-based cohort study of eye disorders among Netherlands residents who were aged 55 and older when first assessed in 1991-93 and who were followed up in 1997-99 as well as in 2002-2006.
The study subjects’ eyes were examined using autorefraction, keratometry, measurement of visual acuity, tonometry, fundus photography, tomographic imaging, and visual field testing.
For this study, a subset of 3,939 subjects who were free of glaucoma at baseline and were followed for a mean of 10 years were assessed. A total of 108 (2.7%) developed glaucoma during that time.
Overall, the only difference in lifestyle factors between subjects who developed glaucoma and subjects who did not was obesity. Subjects who developed glaucoma had a significantly lower body mass index than did those who did not.
Further analysis showed that this association was present only among women. In women, each unit increase in BMI was associated with a 7% reduction in the risk of developing glaucoma, the investigators said (Arch. Ophthalmol. 2011 Feb. 14 [doi:10.1001/archophthalmol.2010.373]).
There also was no association between glaucoma risk and alcohol intake when the data were broken down according to the percentage of alcohol in various drinks. Subjects who drank beverages with a comparatively low alcohol content (such as beer and wine) showed the same risk of developing glaucoma as did subjects who drank beverages with a moderate alcohol content (such as port wine or sherry) or the strongest alcohol content (such as hard liquor).
The study had one paradoxical finding: BMI was inversely related to intraocular pressure. Higher BMI raised the risk of higher intraocular pressure, which in turn should have raised rather than lowered the risk of developing glaucoma among women.
The reason for this contradiction is not yet known, but given the discrepant results between men and women, it may be related to estrogen levels. Body fat has estrogenic effects, so it’s possible that higher BMI raises intraocular pressure but these estrogenic effects protect against glaucoma, Dr. Ramdas and associates wrote.
They also suggested that the protective effect could be related to an instrument used in the study: “An explanation for this finding is that, with Goldmann applanation tonometry, the thorax and abdomen are pushed against the slitlamp table while breath holding works like a Valsalva maneuver” especially for obese women. This could lead to an overestimation of IOP which may have contributed to this inverse association, they wrote.
Only one lifestyle factor – obesity – was found to influence a patient’s risk for open-angle glaucoma, and it exerted a protective effect in women only, according to a study published Feb. 14 in the Archives of Ophthalmology.
Patient education level, income, smoking status, and alcohol intake all had no association with risk for developing glaucoma, and obesity had no association with glaucoma risk among men, said Dr. Wishal D. Ramdas of the departments of epidemiology and ophthalmology at Erasmus Medical center, Rotterdam, The Netherlands, and associates.
Previous studies of glaucoma risk have yielded conflicting results regarding lifestyle factors. Conclusions about smoking and alcohol intake in particular have been very mixed. Dr. Ramdas and colleagues examined the issue using data from the Rotterdam Study, a prospective population-based cohort study of eye disorders among Netherlands residents who were aged 55 and older when first assessed in 1991-93 and who were followed up in 1997-99 as well as in 2002-2006.
The study subjects’ eyes were examined using autorefraction, keratometry, measurement of visual acuity, tonometry, fundus photography, tomographic imaging, and visual field testing.
For this study, a subset of 3,939 subjects who were free of glaucoma at baseline and were followed for a mean of 10 years were assessed. A total of 108 (2.7%) developed glaucoma during that time.
Overall, the only difference in lifestyle factors between subjects who developed glaucoma and subjects who did not was obesity. Subjects who developed glaucoma had a significantly lower body mass index than did those who did not.
Further analysis showed that this association was present only among women. In women, each unit increase in BMI was associated with a 7% reduction in the risk of developing glaucoma, the investigators said (Arch. Ophthalmol. 2011 Feb. 14 [doi:10.1001/archophthalmol.2010.373]).
There also was no association between glaucoma risk and alcohol intake when the data were broken down according to the percentage of alcohol in various drinks. Subjects who drank beverages with a comparatively low alcohol content (such as beer and wine) showed the same risk of developing glaucoma as did subjects who drank beverages with a moderate alcohol content (such as port wine or sherry) or the strongest alcohol content (such as hard liquor).
The study had one paradoxical finding: BMI was inversely related to intraocular pressure. Higher BMI raised the risk of higher intraocular pressure, which in turn should have raised rather than lowered the risk of developing glaucoma among women.
The reason for this contradiction is not yet known, but given the discrepant results between men and women, it may be related to estrogen levels. Body fat has estrogenic effects, so it’s possible that higher BMI raises intraocular pressure but these estrogenic effects protect against glaucoma, Dr. Ramdas and associates wrote.
They also suggested that the protective effect could be related to an instrument used in the study: “An explanation for this finding is that, with Goldmann applanation tonometry, the thorax and abdomen are pushed against the slitlamp table while breath holding works like a Valsalva maneuver” especially for obese women. This could lead to an overestimation of IOP which may have contributed to this inverse association, they wrote.
FROM THE ARCHIVES OF OPHTHALMOLOGY
Major Finding: Obesity - but not education level, income, smoking status, and alcohol intake - influenced a patient's risk of developing open-angle glaucoma. The protective effect was in women only: Each unit increase in body mass index was associated with a 7% reduction in the risk.
Data Source: A secondary analysis of data from the Rotterdam Study, a prospective population-based cohort study of the development of eye disorders among older residents of the Netherlands.
Disclosures: This work was supported by device firms Topcon Europe BV and Heidelberg Engineering. Support also was provided by Stichting Lijf en Leven, MD Fonds, Rotterdamse Vereniging Blindenbelangen, Stichting Oogfonds Nederland, Blindenpenning, Blindenhulp, Algemene Nederlandse Vereniging ter Voorkoming van Blindheid, Landelijke Stichting voor Blinden en Slechtzienden, Swart van Essen, Stichting Winckel-Sweep, Henkes Stichting, Lame´ris Ootech BV, and Medical Workshop. The authors reported financial ties to Topcon Europe BV, Capelle aan de IJssel, and Heidelberg Engineering.
Study: High Fiber Consumption May Lower All-Cause Mortality
Compared with people who consume low levels of dietary fiber, those who consume high levels have decreased rates of all-cause, cardiovascular, infectious, and respiratory mortality, according to a study published online Feb. 14 in Archives of Internal Medicine.
Higher fiber intake also was related to decreased cancer mortality, but only among men, said Yikyung Park, Sc.D., of the nutritional epidemiology branch of the National Cancer Institute, Rockville, Md., and her associates.
The study findings suggest that choosing fiber-rich foods may have across-the-board health benefits, and may reduce the risk of premature death from all causes, they noted.
Many observational studies examining the effect of dietary fiber on mortality have been limited by small sample sizes, narrow ranges of fiber intakes, and inadequate control for confounding factors; and therefore many of the studies have produced inconsistent results.
The investigators examined the issue using data from a large cohort - participants in the National Institutes of Health/American Association of Retired Persons Diet and Health Study.
The NIH/AARP study involved more than 567,000 men and women, aged 50-71 years, residing in six states and two metropolitan areas, who completed detailed questionnaires about their diets in 1995-96 and were followed for a mean of 9 years. For this analysis, the responses of 219,123 men and 168,999 women were assessed.
There were 20,126 deaths among men and 11,330 among women during follow-up, including 7,845 deaths due to cardiovascular disease (CVD) and 13,171 cancer deaths. Dietary fiber intake ranged from 11 grams per day on the low end to 29 grams per day on the high end.
Compared with people in the lowest quintile of fiber consumption, those in the highest quintile had a 22% lower risk of death from all causes, Dr. Park and her colleagues reported (Arch. Intern. Med. 2011 Feb. 14 [doi:10.1001/archinternmed.2011.18]).
Because smoking status was a strong confounder in the analysis, the data were analyzed again after subjects were stratified by smoking status. Among people who had never smoked, the inverse association between fiber consumption and total mortality remained significant for men and women. It also remained significant among former smokers and current smokers.
Similarly, the inverse association between fiber intake and mortality remained strong across all categories of body mass index.
Men in the highest quintile of fiber consumption had a 24%-56% lower risk of death from CVD, cancer, infectious disease, or respiratory disease than did men in the lowest quintile. Women in the highest quintile of fiber consumption had a 34%-59% lower risk of death from CVD, infectious disease, or respiratory disease, but there was no inverse association between fiber intake and cancer mortality in women.
This discrepancy may be explained in part by differences between men and women in leading organ sites for cancer deaths, the investigators noted.
In a further analysis, the data were adjusted to account for the use of aspirin therapy, the presence of hypertension, and the presence of cholesterolemia. "No appreciable differences" in the link between dietary fiber and mortality were found.
When the data were analyzed by fiber source, high dietary fiber from grains was significantly associated with decreased mortality, while fiber from vegetables and beans showed a weaker association and fiber from fruits showed no association.
Several plausible mechanisms have been suggested to explain the benefits of dietary fiber. Fiber's anti-inflammatory properties may explain its protective effect across several types of disease, Dr. Park and her associates proposed.
However, it also is possible that high consumption of dietary fiber in this study was simply a marker for a healthy diet and lifestyle.
Study subjects in the highest quintile of fiber intake were more likely to have a higher education, a lower BMI, and a higher level of physical activity, and to have rated their health as being very good or excellent, compared with subjects in lower quintiles. Although these factors were controlled for in multivariate analyses, some residual confounding may have persisted, the researchers said.
"This carefully conducted study adds further evidence supporting the multiple health benefits of dietary fiber," wrote Lawrence de Koning, Ph.D., and Dr. Frank B. Hu in an accompanying editorial.
The "most striking" finding was the strong association between fiber intake and death from infectious or respiratory diseases.
Yikyung Park and her associates propose the intriguing argument that fiber's benefits, particularly those of whole grains, stem from anti-inflammatory and antioxidant properties. "The intake of whole grains might plausibly reduce the severity of a number of different diseases, which could explain the low mortality rates observed.
"It would be interesting if the authors repeated their analyses on diseases classified by inflammatory origin, as this might help to further test this hypothesis," Dr. de Koning and Dr. Hu wrote.
Dr. de Koning and Dr. Hu, are at the Harvard School of Public Health Channing Laboratory, Boston. They reported having no financial conflicts of interest. These comments were taken from their invited commentary, which accompanied the report of Dr. Park and her colleagues (Arch. Intern. Med. 2011 Feb. 14 [doi.10.1001/archinternmed.2011.19]).
.
"This carefully conducted study adds further evidence supporting the multiple health benefits of dietary fiber," wrote Lawrence de Koning, Ph.D., and Dr. Frank B. Hu in an accompanying editorial.
The "most striking" finding was the strong association between fiber intake and death from infectious or respiratory diseases.
Yikyung Park and her associates propose the intriguing argument that fiber's benefits, particularly those of whole grains, stem from anti-inflammatory and antioxidant properties. "The intake of whole grains might plausibly reduce the severity of a number of different diseases, which could explain the low mortality rates observed.
"It would be interesting if the authors repeated their analyses on diseases classified by inflammatory origin, as this might help to further test this hypothesis," Dr. de Koning and Dr. Hu wrote.
Dr. de Koning and Dr. Hu, are at the Harvard School of Public Health Channing Laboratory, Boston. They reported having no financial conflicts of interest. These comments were taken from their invited commentary, which accompanied the report of Dr. Park and her colleagues (Arch. Intern. Med. 2011 Feb. 14 [doi.10.1001/archinternmed.2011.19]).
.
"This carefully conducted study adds further evidence supporting the multiple health benefits of dietary fiber," wrote Lawrence de Koning, Ph.D., and Dr. Frank B. Hu in an accompanying editorial.
The "most striking" finding was the strong association between fiber intake and death from infectious or respiratory diseases.
Yikyung Park and her associates propose the intriguing argument that fiber's benefits, particularly those of whole grains, stem from anti-inflammatory and antioxidant properties. "The intake of whole grains might plausibly reduce the severity of a number of different diseases, which could explain the low mortality rates observed.
"It would be interesting if the authors repeated their analyses on diseases classified by inflammatory origin, as this might help to further test this hypothesis," Dr. de Koning and Dr. Hu wrote.
Dr. de Koning and Dr. Hu, are at the Harvard School of Public Health Channing Laboratory, Boston. They reported having no financial conflicts of interest. These comments were taken from their invited commentary, which accompanied the report of Dr. Park and her colleagues (Arch. Intern. Med. 2011 Feb. 14 [doi.10.1001/archinternmed.2011.19]).
.
Compared with people who consume low levels of dietary fiber, those who consume high levels have decreased rates of all-cause, cardiovascular, infectious, and respiratory mortality, according to a study published online Feb. 14 in Archives of Internal Medicine.
Higher fiber intake also was related to decreased cancer mortality, but only among men, said Yikyung Park, Sc.D., of the nutritional epidemiology branch of the National Cancer Institute, Rockville, Md., and her associates.
The study findings suggest that choosing fiber-rich foods may have across-the-board health benefits, and may reduce the risk of premature death from all causes, they noted.
Many observational studies examining the effect of dietary fiber on mortality have been limited by small sample sizes, narrow ranges of fiber intakes, and inadequate control for confounding factors; and therefore many of the studies have produced inconsistent results.
The investigators examined the issue using data from a large cohort - participants in the National Institutes of Health/American Association of Retired Persons Diet and Health Study.
The NIH/AARP study involved more than 567,000 men and women, aged 50-71 years, residing in six states and two metropolitan areas, who completed detailed questionnaires about their diets in 1995-96 and were followed for a mean of 9 years. For this analysis, the responses of 219,123 men and 168,999 women were assessed.
There were 20,126 deaths among men and 11,330 among women during follow-up, including 7,845 deaths due to cardiovascular disease (CVD) and 13,171 cancer deaths. Dietary fiber intake ranged from 11 grams per day on the low end to 29 grams per day on the high end.
Compared with people in the lowest quintile of fiber consumption, those in the highest quintile had a 22% lower risk of death from all causes, Dr. Park and her colleagues reported (Arch. Intern. Med. 2011 Feb. 14 [doi:10.1001/archinternmed.2011.18]).
Because smoking status was a strong confounder in the analysis, the data were analyzed again after subjects were stratified by smoking status. Among people who had never smoked, the inverse association between fiber consumption and total mortality remained significant for men and women. It also remained significant among former smokers and current smokers.
Similarly, the inverse association between fiber intake and mortality remained strong across all categories of body mass index.
Men in the highest quintile of fiber consumption had a 24%-56% lower risk of death from CVD, cancer, infectious disease, or respiratory disease than did men in the lowest quintile. Women in the highest quintile of fiber consumption had a 34%-59% lower risk of death from CVD, infectious disease, or respiratory disease, but there was no inverse association between fiber intake and cancer mortality in women.
This discrepancy may be explained in part by differences between men and women in leading organ sites for cancer deaths, the investigators noted.
In a further analysis, the data were adjusted to account for the use of aspirin therapy, the presence of hypertension, and the presence of cholesterolemia. "No appreciable differences" in the link between dietary fiber and mortality were found.
When the data were analyzed by fiber source, high dietary fiber from grains was significantly associated with decreased mortality, while fiber from vegetables and beans showed a weaker association and fiber from fruits showed no association.
Several plausible mechanisms have been suggested to explain the benefits of dietary fiber. Fiber's anti-inflammatory properties may explain its protective effect across several types of disease, Dr. Park and her associates proposed.
However, it also is possible that high consumption of dietary fiber in this study was simply a marker for a healthy diet and lifestyle.
Study subjects in the highest quintile of fiber intake were more likely to have a higher education, a lower BMI, and a higher level of physical activity, and to have rated their health as being very good or excellent, compared with subjects in lower quintiles. Although these factors were controlled for in multivariate analyses, some residual confounding may have persisted, the researchers said.
Compared with people who consume low levels of dietary fiber, those who consume high levels have decreased rates of all-cause, cardiovascular, infectious, and respiratory mortality, according to a study published online Feb. 14 in Archives of Internal Medicine.
Higher fiber intake also was related to decreased cancer mortality, but only among men, said Yikyung Park, Sc.D., of the nutritional epidemiology branch of the National Cancer Institute, Rockville, Md., and her associates.
The study findings suggest that choosing fiber-rich foods may have across-the-board health benefits, and may reduce the risk of premature death from all causes, they noted.
Many observational studies examining the effect of dietary fiber on mortality have been limited by small sample sizes, narrow ranges of fiber intakes, and inadequate control for confounding factors; and therefore many of the studies have produced inconsistent results.
The investigators examined the issue using data from a large cohort - participants in the National Institutes of Health/American Association of Retired Persons Diet and Health Study.
The NIH/AARP study involved more than 567,000 men and women, aged 50-71 years, residing in six states and two metropolitan areas, who completed detailed questionnaires about their diets in 1995-96 and were followed for a mean of 9 years. For this analysis, the responses of 219,123 men and 168,999 women were assessed.
There were 20,126 deaths among men and 11,330 among women during follow-up, including 7,845 deaths due to cardiovascular disease (CVD) and 13,171 cancer deaths. Dietary fiber intake ranged from 11 grams per day on the low end to 29 grams per day on the high end.
Compared with people in the lowest quintile of fiber consumption, those in the highest quintile had a 22% lower risk of death from all causes, Dr. Park and her colleagues reported (Arch. Intern. Med. 2011 Feb. 14 [doi:10.1001/archinternmed.2011.18]).
Because smoking status was a strong confounder in the analysis, the data were analyzed again after subjects were stratified by smoking status. Among people who had never smoked, the inverse association between fiber consumption and total mortality remained significant for men and women. It also remained significant among former smokers and current smokers.
Similarly, the inverse association between fiber intake and mortality remained strong across all categories of body mass index.
Men in the highest quintile of fiber consumption had a 24%-56% lower risk of death from CVD, cancer, infectious disease, or respiratory disease than did men in the lowest quintile. Women in the highest quintile of fiber consumption had a 34%-59% lower risk of death from CVD, infectious disease, or respiratory disease, but there was no inverse association between fiber intake and cancer mortality in women.
This discrepancy may be explained in part by differences between men and women in leading organ sites for cancer deaths, the investigators noted.
In a further analysis, the data were adjusted to account for the use of aspirin therapy, the presence of hypertension, and the presence of cholesterolemia. "No appreciable differences" in the link between dietary fiber and mortality were found.
When the data were analyzed by fiber source, high dietary fiber from grains was significantly associated with decreased mortality, while fiber from vegetables and beans showed a weaker association and fiber from fruits showed no association.
Several plausible mechanisms have been suggested to explain the benefits of dietary fiber. Fiber's anti-inflammatory properties may explain its protective effect across several types of disease, Dr. Park and her associates proposed.
However, it also is possible that high consumption of dietary fiber in this study was simply a marker for a healthy diet and lifestyle.
Study subjects in the highest quintile of fiber intake were more likely to have a higher education, a lower BMI, and a higher level of physical activity, and to have rated their health as being very good or excellent, compared with subjects in lower quintiles. Although these factors were controlled for in multivariate analyses, some residual confounding may have persisted, the researchers said.
FROM ARCHIVES OF INTERNAL MEDICINE
Major Finding: All-cause mortality was 22% lower among men and women with the highest consumption of dietary fiber, compared with those with the lowest consumption.
Data Source: Secondary analysis of data from the NIH/AARP Diet and Health Study, a prospective cohort study involving over 567,000 men and women followed for an average of 9 years.
Disclosures: The study was supported by the National Cancer Institute. No financial conflicts of interest were reported.
Axillary Lymph Node Dissection Doesn't Improve Breast Cancer Survival
Axillary lymph node dissection did not improve overall survival or disease-free survival in women with T1-T2 breast cancer who were found to have limited metastasis on sentinel node dissection, according to a report in the Feb. 9 issue of JAMA.
In the American College of Surgeons Oncology Group’s Z0011 trial, survival was nearly identical between women who underwent lumpectomy and sentinel node dissection alone, followed by adjuvant chemotherapy and tangential-field whole-breast irradiation, and women who underwent axillary node dissection when sentinel node biopsy revealed limited metastasis, followed by the same chemotherapy and irradiation.
"The findings from Z0011 document the high rate of locoregional control achieved with modern multimodal therapy, even without axillary lymph node dissection," said Dr. Armando E. Giuliano of John Wayne Cancer Institute at Saint John’s Health Center, Santa Monica, California, and his associates.
The results also imply that axillary node dissection is no longer warranted in such patients, because "the only additional information gained ... is the number of nodes containing metastases. This prognostic information is unlikely to change systemic therapy decisions and is obtained at the cost of a significant increase in morbidity," the investigators noted.
Forgoing the standard practice of axillary node dissection when sentinel nodes reveal metastasis constitutes a practice change that "would improve clinical outcomes in thousands of women each year by reducing the complications associated with axillary lymph node dissection and improving quality of life with no diminution in survival," they concluded.
The need for axillary node dissection when sentinel nodes are found to have metastasis has been called into question for years, and use of this "standard" practice has declined. Until now, "no study has conclusively demonstrated a survival benefit or detriment for omitting axillary node dissection."
The ACS Oncology Group’s Z0011 trial, begun in the late 1990s, was intended to definitively answer that question. The phase III "noninferiority" trial involved 891 women who were followed at 115 centers after undergoing lumpectomy and sentinel node dissection revealing metastasis. These subjects were randomly assigned to undergo standard axillary node dissection (445 patients) or no axillary node dissection (446 patients), followed by whole-breast tangential-field radiation (not third-field nodal irradiation) and whatever adjuvant systemic therapy their treating physicians deemed necessary.
The trial’s enrollment was halted early in 2004 "because of concerns regarding the extremely low mortality rate." It was determined that accrual of more patients would not alter the survival findings, and final follow-up for the analysis was completed in 2010.
After a median of 6 years of follow-up, there were 94 deaths. The 5-year overall survival was 92.5% with sentinel node dissection alone and 91.8% with full axillary node dissection, a nonsignificant difference.
The 5-year disease-free survival rate was 83.9% with sentinel node dissection alone and 82.2% with full axillary node dissection, also a nonsignificant difference.
These results were consistent across several subgroups of patients, regardless of patient age, tumor size, tumor hormone-receptor status, or which adjuvant therapies were received.
The two study groups did differ significantly in morbidities related to lymph node dissection. The rate of wound infection, axillary seromas, and paresthesias was markedly higher for women who underwent axillary node dissection (70%) than for those who did not (25%). Lymphedema also was more common with axillary node dissection.
"The excellent local and distant outcomes in this study highlight the effects of multiple changes in breast cancer management" in recent years, including "improved imaging, more detailed pathological evaluation, improved planning of surgical and radiation approaches, and more effective systemic therapy," Dr. Giuliano and his colleagues said (JAMA 2011;305:569-75).
They emphasized that this trial did not include patients who had mastectomy, lumpectomy without radiation therapy, partial-breast irradiation, or whole-breast irradiation in the prone position (which would not treat the low axilla). In such patients, "axillary lymph node dissection remains standard practice when sentinel lymph node dissection identifies a positive sentinel lymph node," the researchers said.
The study was supported by the National Cancer Institute. The researchers reported having no financial conflicts of interest.
The American College of Surgeons Oncology Group Z0011 trial "definitively showed that axillary lymph node dissection is not beneficial," said Dr. Grant Walter Carlson and Dr. William C. Wood.
Even though 27% of the women who underwent axillary node biopsy were found to have additional lymph nodes containing metastases, the axillary recurrence rates were similar between the two groups.
"Survival was independent of lymph node status and was so good in both groups that longer follow-up has little likelihood of demonstrating any difference between the [two] groups," they noted.
"Taken together, findings from these [and other] investigators provide strong evidence that patients undergoing partial mastectomy, whole-breast irradiation, and systemic therapy for early breast cancer with microscopic sentinel lymph node metastasis can be treated effectively and safely without axillary node dissection," they said.
Dr. Carlson and Dr. Wood are at Winship Cancer Institute, Emory University, Atlanta. They reported no financial conflicts of interest. These comments were taken from their editorial that accompanied Dr. Giuliano’s report (JAMA 2011;305:606-7).
The American College of Surgeons Oncology Group Z0011 trial "definitively showed that axillary lymph node dissection is not beneficial," said Dr. Grant Walter Carlson and Dr. William C. Wood.
Even though 27% of the women who underwent axillary node biopsy were found to have additional lymph nodes containing metastases, the axillary recurrence rates were similar between the two groups.
"Survival was independent of lymph node status and was so good in both groups that longer follow-up has little likelihood of demonstrating any difference between the [two] groups," they noted.
"Taken together, findings from these [and other] investigators provide strong evidence that patients undergoing partial mastectomy, whole-breast irradiation, and systemic therapy for early breast cancer with microscopic sentinel lymph node metastasis can be treated effectively and safely without axillary node dissection," they said.
Dr. Carlson and Dr. Wood are at Winship Cancer Institute, Emory University, Atlanta. They reported no financial conflicts of interest. These comments were taken from their editorial that accompanied Dr. Giuliano’s report (JAMA 2011;305:606-7).
The American College of Surgeons Oncology Group Z0011 trial "definitively showed that axillary lymph node dissection is not beneficial," said Dr. Grant Walter Carlson and Dr. William C. Wood.
Even though 27% of the women who underwent axillary node biopsy were found to have additional lymph nodes containing metastases, the axillary recurrence rates were similar between the two groups.
"Survival was independent of lymph node status and was so good in both groups that longer follow-up has little likelihood of demonstrating any difference between the [two] groups," they noted.
"Taken together, findings from these [and other] investigators provide strong evidence that patients undergoing partial mastectomy, whole-breast irradiation, and systemic therapy for early breast cancer with microscopic sentinel lymph node metastasis can be treated effectively and safely without axillary node dissection," they said.
Dr. Carlson and Dr. Wood are at Winship Cancer Institute, Emory University, Atlanta. They reported no financial conflicts of interest. These comments were taken from their editorial that accompanied Dr. Giuliano’s report (JAMA 2011;305:606-7).
Axillary lymph node dissection did not improve overall survival or disease-free survival in women with T1-T2 breast cancer who were found to have limited metastasis on sentinel node dissection, according to a report in the Feb. 9 issue of JAMA.
In the American College of Surgeons Oncology Group’s Z0011 trial, survival was nearly identical between women who underwent lumpectomy and sentinel node dissection alone, followed by adjuvant chemotherapy and tangential-field whole-breast irradiation, and women who underwent axillary node dissection when sentinel node biopsy revealed limited metastasis, followed by the same chemotherapy and irradiation.
"The findings from Z0011 document the high rate of locoregional control achieved with modern multimodal therapy, even without axillary lymph node dissection," said Dr. Armando E. Giuliano of John Wayne Cancer Institute at Saint John’s Health Center, Santa Monica, California, and his associates.
The results also imply that axillary node dissection is no longer warranted in such patients, because "the only additional information gained ... is the number of nodes containing metastases. This prognostic information is unlikely to change systemic therapy decisions and is obtained at the cost of a significant increase in morbidity," the investigators noted.
Forgoing the standard practice of axillary node dissection when sentinel nodes reveal metastasis constitutes a practice change that "would improve clinical outcomes in thousands of women each year by reducing the complications associated with axillary lymph node dissection and improving quality of life with no diminution in survival," they concluded.
The need for axillary node dissection when sentinel nodes are found to have metastasis has been called into question for years, and use of this "standard" practice has declined. Until now, "no study has conclusively demonstrated a survival benefit or detriment for omitting axillary node dissection."
The ACS Oncology Group’s Z0011 trial, begun in the late 1990s, was intended to definitively answer that question. The phase III "noninferiority" trial involved 891 women who were followed at 115 centers after undergoing lumpectomy and sentinel node dissection revealing metastasis. These subjects were randomly assigned to undergo standard axillary node dissection (445 patients) or no axillary node dissection (446 patients), followed by whole-breast tangential-field radiation (not third-field nodal irradiation) and whatever adjuvant systemic therapy their treating physicians deemed necessary.
The trial’s enrollment was halted early in 2004 "because of concerns regarding the extremely low mortality rate." It was determined that accrual of more patients would not alter the survival findings, and final follow-up for the analysis was completed in 2010.
After a median of 6 years of follow-up, there were 94 deaths. The 5-year overall survival was 92.5% with sentinel node dissection alone and 91.8% with full axillary node dissection, a nonsignificant difference.
The 5-year disease-free survival rate was 83.9% with sentinel node dissection alone and 82.2% with full axillary node dissection, also a nonsignificant difference.
These results were consistent across several subgroups of patients, regardless of patient age, tumor size, tumor hormone-receptor status, or which adjuvant therapies were received.
The two study groups did differ significantly in morbidities related to lymph node dissection. The rate of wound infection, axillary seromas, and paresthesias was markedly higher for women who underwent axillary node dissection (70%) than for those who did not (25%). Lymphedema also was more common with axillary node dissection.
"The excellent local and distant outcomes in this study highlight the effects of multiple changes in breast cancer management" in recent years, including "improved imaging, more detailed pathological evaluation, improved planning of surgical and radiation approaches, and more effective systemic therapy," Dr. Giuliano and his colleagues said (JAMA 2011;305:569-75).
They emphasized that this trial did not include patients who had mastectomy, lumpectomy without radiation therapy, partial-breast irradiation, or whole-breast irradiation in the prone position (which would not treat the low axilla). In such patients, "axillary lymph node dissection remains standard practice when sentinel lymph node dissection identifies a positive sentinel lymph node," the researchers said.
The study was supported by the National Cancer Institute. The researchers reported having no financial conflicts of interest.
Axillary lymph node dissection did not improve overall survival or disease-free survival in women with T1-T2 breast cancer who were found to have limited metastasis on sentinel node dissection, according to a report in the Feb. 9 issue of JAMA.
In the American College of Surgeons Oncology Group’s Z0011 trial, survival was nearly identical between women who underwent lumpectomy and sentinel node dissection alone, followed by adjuvant chemotherapy and tangential-field whole-breast irradiation, and women who underwent axillary node dissection when sentinel node biopsy revealed limited metastasis, followed by the same chemotherapy and irradiation.
"The findings from Z0011 document the high rate of locoregional control achieved with modern multimodal therapy, even without axillary lymph node dissection," said Dr. Armando E. Giuliano of John Wayne Cancer Institute at Saint John’s Health Center, Santa Monica, California, and his associates.
The results also imply that axillary node dissection is no longer warranted in such patients, because "the only additional information gained ... is the number of nodes containing metastases. This prognostic information is unlikely to change systemic therapy decisions and is obtained at the cost of a significant increase in morbidity," the investigators noted.
Forgoing the standard practice of axillary node dissection when sentinel nodes reveal metastasis constitutes a practice change that "would improve clinical outcomes in thousands of women each year by reducing the complications associated with axillary lymph node dissection and improving quality of life with no diminution in survival," they concluded.
The need for axillary node dissection when sentinel nodes are found to have metastasis has been called into question for years, and use of this "standard" practice has declined. Until now, "no study has conclusively demonstrated a survival benefit or detriment for omitting axillary node dissection."
The ACS Oncology Group’s Z0011 trial, begun in the late 1990s, was intended to definitively answer that question. The phase III "noninferiority" trial involved 891 women who were followed at 115 centers after undergoing lumpectomy and sentinel node dissection revealing metastasis. These subjects were randomly assigned to undergo standard axillary node dissection (445 patients) or no axillary node dissection (446 patients), followed by whole-breast tangential-field radiation (not third-field nodal irradiation) and whatever adjuvant systemic therapy their treating physicians deemed necessary.
The trial’s enrollment was halted early in 2004 "because of concerns regarding the extremely low mortality rate." It was determined that accrual of more patients would not alter the survival findings, and final follow-up for the analysis was completed in 2010.
After a median of 6 years of follow-up, there were 94 deaths. The 5-year overall survival was 92.5% with sentinel node dissection alone and 91.8% with full axillary node dissection, a nonsignificant difference.
The 5-year disease-free survival rate was 83.9% with sentinel node dissection alone and 82.2% with full axillary node dissection, also a nonsignificant difference.
These results were consistent across several subgroups of patients, regardless of patient age, tumor size, tumor hormone-receptor status, or which adjuvant therapies were received.
The two study groups did differ significantly in morbidities related to lymph node dissection. The rate of wound infection, axillary seromas, and paresthesias was markedly higher for women who underwent axillary node dissection (70%) than for those who did not (25%). Lymphedema also was more common with axillary node dissection.
"The excellent local and distant outcomes in this study highlight the effects of multiple changes in breast cancer management" in recent years, including "improved imaging, more detailed pathological evaluation, improved planning of surgical and radiation approaches, and more effective systemic therapy," Dr. Giuliano and his colleagues said (JAMA 2011;305:569-75).
They emphasized that this trial did not include patients who had mastectomy, lumpectomy without radiation therapy, partial-breast irradiation, or whole-breast irradiation in the prone position (which would not treat the low axilla). In such patients, "axillary lymph node dissection remains standard practice when sentinel lymph node dissection identifies a positive sentinel lymph node," the researchers said.
The study was supported by the National Cancer Institute. The researchers reported having no financial conflicts of interest.
FROM JAMA
Major Finding: Overall 5-year survival was 91.8% with axillary node dissection and 92.5% without it; the 5-year disease-free survival was 82.2% with axillary node dissection and 83.9% without it.
Data Source: A phase III noninferiority trial involving 891 women with invasive node–positive breast cancer treated at 115 medical centers and followed for a median of 6 years.
Disclosures: This study was supported by the National Cancer Institute. No financial conflicts of interest were reported.