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June 22, 2010 — Embargoed Content

JAMA news releases are made available to the public after 3 pm US Central time on the first 4 Tuesdays of each month. The Archives of Journals news releases are made available to the public after 3 pm Central time on Mondays. We also provide a list of previous news releases.

JAMA NEWS RELEASES

Complete Table of Contents
(Embargoed for Release: 3:00 p.m. CT Tuesday, June 22, 2010)

>   Lowering Homocysteine Levels With Folic Acid and Vitamin B12 Does Not Appear to Reduce Risk of Heart Attack, Stroke

>   Study Finds Mixed Results on Effectiveness of Surgical Care Improvement Measures

>   Being Obese, Weight Gain During and After Middle Age Associated With Increased Risk of Diabetes Among Older Adults

>   Study Identifies Reasons for Higher Rate of Severe Sepsis Among Black Patients

JAMA REPORT (VIDEO SCRIPT)

>   VIDEO: Windows Media | Quicktime

>   WEIGHT GAIN AND BODY COMPOSITION CHANGES MIDLIFE INTO OLDER AGE ASSOCIATED WITH INCREASED DIABETES RISK


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EMBARGOED FOR RELEASE UNTIL 3:00 P.M. (CT), Tuesday, June 22, 2010
Media Advisory: To contact Jane M. Armitage, F.R.C.P., email search{at}ctsu.ox.ac.uk.

Lowering Homocysteine Levels With Folic Acid and Vitamin B12 Does Not Appear to Reduce Risk of Heart Attack, Stroke

CHICAGO—Patients who had experienced a heart attack and lowered their blood homocysteine levels with folic acid and vitamin B12 supplementation did not have an associated lower risk of heart attack, coronary death or stroke, according to a study in the June 23/30 issue of JAMA. However, the researchers did find that folic acid supplementation did not increase the risk of cancer, which has been speculated.

Blood homocysteine levels are positively associated with cardiovascular disease, but it is uncertain whether the association is causal, according to background information in the article. A meta-analysis of prospective studies indicated that, after adjustment for known risk factors, a 25 percent lower than usual homocysteine concentration was associated with an 11 percent lower risk of coronary heart disease and 19 percent lower risk of stroke. "Daily supplementation with folic acid typically lowers homocysteine levels by about 25 percent, and the addition of vitamin B12 lowers it by a further 7 percent," the authors write. Other research has suggested supplementation with folic acid may offer a protective effect against stroke.

Jane M. Armitage, F.R.C.P., of the University of Oxford, United Kingdom, and colleagues with the Study of the Effectiveness of Additional Reductions In Cholesterol and Homocysteine (SEARCH) trial assessed the effects of lowering homocysteine levels with folic acid plus vitamin B12 in 12,064 survivors of myocardial infarction (heart attack) in secondary care hospitals in the United Kingdom between 1998 and 2008. Patients were randomized to receive either 2 mg. folic acid plus 1 mg. vitamin B12 daily or matching placebos. The primary outcomes measured included first major vascular event, defined as major coronary event (coronary death, heart attack, or coronary revascularization), fatal or nonfatal stroke, or noncoronary revascularization.

Patients who received the study vitamins reduced homocysteine by an average of 3.8 μmol/L (28 percent). During 6.7 years of follow-up, major vascular events occurred in 1,537 of 6,033 participants (25.5 percent) allocated folic acid plus vitamin B12 vs. 1,493 of 6,031 participants (24.8 percent) allocated placebo. "There was no evidence of any benefit beginning to emerge with more prolonged treatment and follow-up," the authors write.

Receipt of study vitamins also was not associated with a significant effect on any stroke (vitamins, 4.5 percent vs. placebo, 4.4 percent); noncoronary revascularizations (vitamins, 3.0 percent vs. placebo, 2.5 percent); or major coronary events (vitamins, 20.4 percent vs. placebo, 19.6 percent). There were no apparent differences in the numbers of deaths attributed to vascular causes or nonvascular causes.

New primary cancers (excluding non-melanoma skin cancer) were diagnosed in 11.2 percent of the participants allocated folic acid plus vitamin B12 vs. 10.6 percent allocated placebo, with this difference not being significant.

"Taken together with the previous homocysteine-lowering trials, the results of SEARCH indicate that folic acid supplementation has no significant adverse effects on cancer or other major health outcomes, even if it also produces no beneficial effects on cardiovascular disease. In addition, these results highlight the importance of focusing on drug treatments (e.g., aspirin, statins, and antihypertensive therapy) and lifestyle changes (in particular, stopping smoking and avoiding excessive weight gain) that are of proven benefit, rather than lowering homocysteine with folic acid-based vitamin supplements, for the prevention of cardiovascular disease," the authors conclude.
(JAMA 2010;303[24]:2486-2494. Available pre-embargo to the media at www.jamamedia.org)

Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.

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EMBARGOED FOR RELEASE UNTIL 3:00 P.M. (CT), Tuesday, June 22, 2010
Media Advisory: To contact Jonah J. Stulberg, M.D., Ph.D., M.P.H., call Christina DeAngelis at 216-368-3635 or email christina.deangelis{at}case.edu. To contact editorial author Mary T. Hawn, M.D., M.P.H., call Jennifer Lollar at 205-934-3888 or email jpark{at}uab.edu.

Study Finds Mixed Results on Effectiveness of Surgical Care Improvement Measures

CHICAGO—An analysis of data on adherence to surgical care improvement measures finds that when analyzed as a composite infection-prevention score, the improvement measures were associated with a lower probability of postoperative infection. However, adherence to individual measures—the format of publicly reported performance data—was not associated with a significantly lower risk of infection, according to a study in the June 23/30 issue of JAMA.

"The Surgical Care Improvement Project (SCIP), a national quality partnership dedicated to reducing the rate of surgical complications, has developed 20 measures covering various discrete elements of patient care. There are 9 publicly reported SCIP measures, 6 of which focus on postoperative infection prevention," the authors write. Validated data from hospitals are reported on the Health & Human Services (HHS) Web site, Hospital Compare. "Despite broad support from national stakeholders and a significant investment of time and money by the hospitals to collect these data, no large-scale investigation has been undertaken to evaluate their effectiveness for improving outcomes in routine clinical care."

Jonah J. Stulberg, M.D., Ph.D., M.P.H., of Case Western Reserve University, Cleveland, and colleagues conducted a study to evaluate the association between the 6 infection-prevention SCIP measures and postoperative infection rates in a representative sample of hospital discharges in the United States. The study included data for discharges between July 2006 and March 2008 of 405,720 patients (69 percent white and 11 percent black; 46 percent Medicare patients; and 68 percent elective surgical cases) from 398 hospitals in the United States for whom SCIP performance was recorded and submitted for public report on the Hospital Compare Web site. Three original infection-prevention measures (S-INF-Core) and all 6 infection-prevention measures (S-INF) were aggregated into 2 separate all-or-none composite scores. The measures are on processes that include prophylactic antibiotic administration, glucose control, hair removal from the surgical site, and maintaining normal body temperature during surgery.

There were 3,996 documented postoperative infections. The researchers found that demonstrated adherence to SCIP as measured through the all-or-none global composite S-INF was associated with a decreased likelihood of developing a postoperative infection from 14.2 to 6.8 postoperative infections per 1,000 discharges. "However, the S-INF-Core composite was not statistically significant in its association with decreased likelihood of developing a postoperative infection (from 11.5 to 5.3 postoperative infections per 1,000 discharges). In addition, reported adherence on individual SCIP items was not associated with decreased risk of postoperative infection," the authors write.

"Based on our findings, the individual item performance rates reported publicly do not fulfill their stated purpose of pointing consumers toward high-quality hospitals. However, when taken in aggregate, improved performance on our global all-or-none composite measure is associated with improved outcomes at the discharge level. Therefore, while the individual items may not imply quality differences, the overall ability to demonstrate adherence to multiple SCIP processes of care may. Improved methods for identification of quality of care are necessary to be able to define improvements in patient outcomes, and to justify the massive investment of time and money in tracking these processes of care."
(JAMA 2010;303[24]:2479-2485. Available pre-embargo to the media at www.jamamedia.org)

Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Editorial: Surgical Care Improvement - Should Performance Measures Have Performance Measures

Mary T. Hawn, M.D., M.P.H., of the University of Alabama, Birmingham, writes in an accompanying editorial that it appears that investing resources in SCIP reporting is no longer cost-effective.

"Ideal surgical quality-improvement efforts would measure whether the right patient receives the right operation at the right time and whether the operation is effective. This is more challenging to measure given the complex nature of the health care system, including barriers to access, financial incentives, and the uniqueness of the therapeutic intent of individual surgical procedures. Current mandated surgical quality-improvement processes such as SCIP focus on incremental and narrow process measures that are purported to measure the overall quality of an episode of surgical care. Despite enormous resources committed to these measures and marked improvement in adherence, the evidence to date suggests that SCIP has not improved surgical outcomes. Future quality-improvement endeavors should have linkage between discrete performance and outcome measures so the effectiveness of combined efforts can be unequivocally measured and clearly evaluated."
(JAMA 2010;303[24]:2527-2528. Available pre-embargo to the media at www.jamamedia.org)

Editor's Note: Please see the article for additional information, including financial disclosures, funding and support, etc.

For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.

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EMBARGOED FOR RELEASE UNTIL 3:00 P.M. (CT), Tuesday, June 22, 2010
Media Advisory: To contact Mary L. Biggs, Ph.D., call Clare Hagerty at 206-685-1323 or email clareh{at}u.washington.edu.

Being Obese, Weight Gain During and After Middle Age Associated With Increased Risk of Diabetes Among Older Adults

CHICAGO—For individuals 65 years of age and older, obesity, excess body fat around the waist and gaining weight after the age of 50 are associated with an increased risk of diabetes, according to a study in the June 23/30 issue of JAMA.

"Incidence of diabetes in the United States has doubled in the past 15 years, and is highest among adults 65 to 79 years of age. Approximately 70 percent of U.S. men and women 60 years of age and older are overweight or obese [BMI - body mass index 25 or greater]. Adiposity [body fat] is a well-recognized risk factor for type 2 diabetes among young and middle-aged adults, however, the relationships between different measures of body composition and diabetes in older adults [65 years of age or older] are not well described," the authors write.

Mary L. Biggs, Ph.D., of the University of Washington, Seattle, and colleagues examined the relationship between measures of overall body fat, fat distribution, changes in these measures, and diabetes risk among 4,193 men and women 65 years of age and older. Measures of adiposity were determined when participants entered the study, and repeated 3 years later. The incidence of diabetes was ascertained based on use of antidiabetic medication or a fasting blood glucose level of 126 mg/dL or greater.

Over a median (midpoint) follow-up of 12.4 years, 339 new cases of diabetes were diagnosed among the study participants. The researchers found that BMI at baseline, BMI at 50 years of age, weight, fat mass, waist circumference, waist-hip ratio, and waist-height ratio were all strongly related to the risk of diabetes. "For each measure, there was a graded increase in the risk of diabetes with increasing quintiles of adiposity. Participants in the highest category of adiposity had an approximately 2- to 6-fold increased risk of developing diabetes compared with those in the lowest category. We found no evidence of significant statistical interaction by sex or race," the authors write.

Also, compared with participants whose weight remained stable (plus or minus 4.4 lbs.) over the time period, those who gained 20 lbs. or more between the age of 50 years and study entry had an approximately 3-fold greater risk of developing diabetes during follow-up, regardless of their BMI at 50 years of age. Participants who were obese (BMI 30 or greater) at 50 years of age and who experienced the most weight gain (more than 20 lbs.) between the age of 50 years and study entry had 5 times the risk of developing diabetes compared with weight-stable participants with normal BMI (less than 25) at 50 years of age.

The researchers also found that participants in the highest categories of both BMI and waist circumference had more than 4 times the risk of those in the lowest category of both measures. Participants with a greater than 4 inch increase in waist size from baseline to the third follow-up visit had a 70 percent higher risk of type 2 diabetes compared with those who gained or lost 0.8 inches or less.

"Results of this study affirm the importance of maintaining optimal weight during middle age for prevention of diabetes and, while requiring confirmation, suggest that weight control remains important in reducing diabetes risk among adults 65 years of age and older," the authors conclude.
(JAMA 2010;303[24]:2504-2512. Available pre-embargo to the media at www.jamamedia.org)

Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.

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EMBARGOED FOR RELEASE UNTIL 3:00 P.M. (CT), Tuesday, June 22, 2010
Media Advisory: To contact corresponding author Sachin Yende, M.D., M.S., call Anita Srikameswaran at 412-578-9193 or email srikamav{at}upmc.edu.

Study Identifies Reasons for Higher Rate of Severe Sepsis Among Black Patients

CHICAGO—A greater frequency of severe sepsis among black patients is attributable to higher rates of infection and higher risks of organ dysfunction than what white patients experience, according to a study in the June 23/30 issue of JAMA.

Severe sepsis, defined as infection complicated by acute organ dysfunction, affects more than 750,000 U.S. residents each year, with a hospital mortality of 28 percent, and occurs more frequently and leads to more deaths in black patients than in white patients. "However, it is not known whether these disparities occur because of differences in susceptibility to infection or in the risk of developing acute organ dysfunction once infection has occurred. This distinction is important for developing interventions to reduce disparities," the authors write.

Florian B. Mayr, M.D., M.P.H., of the University of Pittsburgh, and colleagues conducted a study to determine the extent to which previously reported racial differences in severe sepsis incidence were due to a higher infection rate or a higher risk of acute organ dysfunction. The study included an analysis of infection-related hospitalizations from the 2005 hospital discharge data of 7 U.S. states and infection-related emergency department visits from the 2003-2007 National Hospital Ambulatory Care Survey. Of 8,661,227 non-childbirth-related discharges, 2,261,857 were associated with an infection, and of these, 381,787 (16.8 percent) had severe sepsis.

The researchers found that black patients had a 67 percent higher severe sepsis hospitalization rate than did white patients (9.4 vs. 5.6 per 1000 population). "The higher severe sepsis rate was explained by both a higher infection rate in black patients (47.3 vs. 34.0 per 1000 population) and a higher risk of developing acute organ dysfunction," the authors write.

Also, infection and severe sepsis mortality rates were 1.5-fold and 1.8-fold higher in black than in white patients.

Analysis indicated that higher hospital infection rates among black patients were not because they were more likely to be admitted with an infection or that black patients were more likely to receive care at hospitals with higher recorded infection rates than white patients. The researchers also found that racial disparities in infection and severe sepsis incidence and mortality rates were largest among younger adults. The proportion of invasive pneumococcal disease occurring in adults less than 65 years of age was 73.9 percent among black patients vs. 44.5 percent among white patients.

"In conclusion, higher severe sepsis rates among black patients are explained by both higher infection-related hospitalization rates and a higher risk of acute organ dysfunction. Reducing these racial disparities will require community-based interventions, such as vaccination, improved management of chronic diseases, and hospital-based interventions targeted especially to hospitals that serve large proportions of black patients. Current guidelines for pneumococcal vaccination, one of the largest and most effective strategies to prevent severe sepsis, do not target up to 25 percent of cases among blacks," the authors write.
(JAMA 2010;303[24]:2495-2503. Available pre-embargo to the media at www.jamamedia.org)

Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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JAMA REPORTS

VIDEO: Windows Media | Quicktime

WEIGHT GAIN AND BODY COMPOSITION CHANGES MIDLIFE INTO OLDER AGE ASSOCIATED WITH INCREASED DIABETES RISK

INTRO:
The incidence of diabetes in the United States has doubled over the past 15 years. Being overweight and obese along with changing body composition are well-recognized risk factors for developing the disease in young and middle-aged adults but what about the risks for older Americans? A new study shows those 65 and older who become overweight or obese are also at an increased risk for developing diabetes. Catherine Dolf has more in this week's JAMA Report.

AUDIO:
NATSO/FULL RUNS : 03
"...I try to avoid what gives you diabetes..."

VIDEO:
B-ROLL
Older couple walking, heavy older people walking

AUDIO:
VO
FOR MANY OLDER AMERICANS THAT'S NOT AS EASY AS IT SOUNDS. TODAY, INCIDENCE OF DIABETES IS HIGHEST AMONG ADULTS AGED 65 TO 79. BEING OVERWEIGHT OR OBESE, LOSING LEAN MUSCLE TO FAT AND FINDING THAT FAT SHIFTING TO THE WAIST AND HIPS HELPS INCREASE DIABETES RISK.

AUDIO:
SOT/FULL Super @ :19 Mary L. Biggs, Ph.D., - University of Washington, Seattle Runs :08
"We found it surprising that the relationship between adiposity or body fat and diabetes was so strong among older adults."

AUDIO:
SOT/FULL Super @ :28 David S. Siscovick, M.D., - University of Washington, Seattle Runs :10
"Our study suggests that obesity in older adults may also have health consequences specifically as it relates to the development of diabetes later in life."

VIDEO:
B-ROLL
Dr. Biggs and Dr. Siscovick in lab looking at computer, cu of both doctors, cu of study, both doctor's at computer, cu of computer screen, doctor pointing at screen, people coming down steps

AUDIO:
VO
DR.'S MARY LOU BIGGS AND DAVID SISCOVICK FROM THE UNIVERSITY OF WASHINGTON AND CO-AUTHORS STUDIED MORE THAN FOUR THOUSAND ADULTS AGED 65 AND OLDER FROM 1989 TO 2007 LOOKING AT MULTIPLE MEASURES INCLUDING WEIGHT, HEIGHT, BODY FAT AND WAIST SIZE.

AUDIO:
SOT/FULL Super @ :53 David S. Siscovick, M.D., - University of Washington, Seattle Runs :16
"If you were in the upper fifth of the population that we studied, the upper 20 percent of the population in terms of multiple measures of adiposity you had a four fold increase risk of developing diabetes late in life."

AUDIO SOT/FULL Super @ 1:09 Mary L. Biggs, Ph.D., - University of Washington, Seattle Runs :15 "Individuals who gained 20 pounds or more between the ages of 50 and 65 had an increased risk of diabetes that was two to three fold times higher than those whose weight remained more or less stable.

AUDIO:
SOT/FULL Super @ 1:09 Mary L. Biggs, Ph.D., - University of Washington, Seattle Runs :15
"Individuals who gained 20 pounds or more between the ages of 50 and 65 had an increased risk of diabetes that was two to three fold times higher than those whose weight remained more or less stable.

JAMA COVER
GXF FULL

AUDIO:
VO
THE STUDY APPEARS IN THIS WEEK'S JAMA, JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

VIDEO:
B-ROLL
Map on computer screen, pullout to both doctors, map changes color and years

AUDIO:
VO
THIS MAP PROVIDED BY THE CENTERS FOR DISEASE CONTROL, REFLECTS THE TIME PERIOD EXAMINED IN THE STUDY WHEN IT COMES TO THE RISE IN OVERWEIGHT AND OBESITY NATIONWIDE. IN 1989, MOST OF THE COUNTRY HAD THEIR WEIGHT IN CHECK, REFLECTED BY A MOSTLY BLUE MAP. FAST FORWARD 17 YEARS TO 2007 AND IT'S A MUCH DIFFERENT STORY.

AUDIO:
NATSO/FULL RUNS :06
"....Many states have prevalent rates of obesity of 25 percent or even 30 percent....right..."

AUDIO:
SOT/FULL Super @ 1:58 Mary L. Biggs, Ph.D., - University of Washington, Seattle Runs :11
"I think the results affirm the importance of weight control during middle age and suggest that weight control remains important into older ages in terms of reducing diabetes risks."

AUDIO:
VO
CATHERINE DOLF, THE JAMA REPORT

TAG:
RESEARCHERS SAY PRIOR TO THIS STUDY THERE WAS VERY LIMITED INFORMATION REGARDING BODY FAT AND DIABETES RISK IN OLDER ADULTS.

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