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.
THIS WEEK'S CONTENTS
ARCHIVES OF INTERNAL MEDICINE NEWS RELEASES
(Embargoed Until: 3 P.M. (CT), Monday, December 8, 2008)
HALF-DOSE FLU SHOT APPEARS TO PRODUCE IMMUNE RESPONSE IN YOUNG, HEALTHY ADULTS
MEDITERRANEAN DIET PLUS NUTS MAY BE HELPFUL IN MANAGING METABOLIC SYNDROME
ELECTRONIC PRESCRIBING SYSTEM MAY ENCOURAGE PHYSICIANS TO CHOOSE LOWER-COST DRUGS
ARCHIVES OF OPHTHALMOLOGY NEWS RELEASES
(Embargoed Until: 3 P.M. (CT), December 8, 2008)
AGE-RELATED FARSIGHTEDNESS MAY AFFECT MORE THAN 1 BILLION WORLDWIDE
OCCURRENCE OF MAJOR EYE DISEASE PROJECTED TO INCREASE AMONG PATIENTS WITH DIABETES
ARCHIVES OF NEUROLOGY NEWS RELEASES
(Embargoed Until: 3 P.M. (CT), December 8, 2008)
CLINICAL TRIAL PARTICIPANTS VALUE PERSONALIZED, ACCURATE INFORMATION ABOUT STUDY RESULTS
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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, December 8, 2008
Media Advisory: To contact Renata J.M. Engler, M.D., call Walter Reed Army Medical Center
Community Relations at 202-782-9351. To contact editorial author Ann R. Falsey, M.D., call Michael Tedesco at 585-922-3677.
HALF-DOSE FLU SHOT APPEARS TO PRODUCE IMMUNE RESPONSE IN YOUNG, HEALTHY ADULTS
CHICAGO—Individuals younger than 50 who have been previously vaccinated do not appear to have a substantially different immune response to a half-dose of influenza vaccine than to a full dose, according to a report in the December 8/22 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. This suggests that half-dose vaccination in healthy young individuals may be effective in times of vaccine shortage.
"Since 2002, optimum influenza vaccine delivery has been impaired as a result of supply shortages," the authors write as background information in the article. "With the abrupt loss of half the anticipated national influenza vaccine supply in October 2004, the option of using a reduced dose for immunization of healthy, high-priority groups became a critical consideration."
Renata J.M. Engler, M.D., of Walter Reed Army Medical Center, Washington, DC, and colleagues conducted a randomized clinical trial involving healthy adults age 18 to 64 years. Between November and December 2004, a total of 554 adults received a full dose of trivalent inactivated influenza vaccine and 556 received a half-dose of the vaccine. All had been vaccinated within the past one to three years. Blood samples were taken before and 21 days after vaccination and tested for antibodies against influenza, and participants recorded any symptoms they experienced during this time period.
"Antibody responses to intramuscular half-dose trivalent inactivated influenza vaccine in healthy, previously immunized adults were not substantially inferior to the full-dose vaccine, particularly for ages 18 to 49 years," the authors write. In addition, from November 2004 through March 2005, rates of medical visits for respiratory or cardiovascular reasons were no different between those vaccinated with a full dose or with a half dose. "Given the benefits of immunizing healthy working adults and caregivers, these data support the validity of a dose reduction strategy in the setting of vaccine shortages."
"Reduced dosing could have a significant impact on the response to vaccine shortages, particularly at a local level when faced with considerable delays in vaccine supply delivery," they continue. Because half-doses were associated with fewer side effects, reducing dosage could also make vaccination more acceptable, particularly among groups of people who experience more adverse effects.
Women of all ages had a greater response to both doses of the vaccine than men. In fact, women receiving a half-dose of vaccine had similar antibody responses to men receiving a full dose. "These findings suggest that guidelines for vaccine use during shortages should take sex as well as age into consideration," the authors write. "As recommendations for influenza immunization expand and evidence that elderly persons (men older than 60 years) may require higher doses of vaccine for optimal responses, reduced doses in healthy, younger populations may become a valuable national strategy."
(Arch Intern Med. 2008;168[22]:2405-2414. Available to the media pre-embargo at www.jamamedia.org).
Editor's Note: This study was supported by the Office of the Army Surgeon General in collaboration with Walter Reed Army Medical Center and Healthcare System; the North Atlantic Regional Medical Command; the U.S. Army Medical Research and Materiel Command; the National Institute of Allergy and Infectious Diseases, National Institutes of Health; and the Influenza Branch of the Centers for Disease Control and Prevention. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
EDITORIAL: BETTER METHODS OF VACCINE PRODUCTION NEEDED
"The production of adequate supplies of yearly influenza vaccine is challenging for a number of reasons, including the need to anticipate new circulating strains in advance, adaptation of new variants for growth in embryonated hens' eggs and an expanding target population," writes Ann R. Falsey, M.D., of Rochester General Hospital, N.Y., in an accompanying editorial.
"If more antibodies are better, how much is 'good enough' in a time of critical vaccine shortage?" Dr. Falsey continues. "In trying to stretch vaccine supplies to protect the largest number of persons, we must use care to not waste vaccine by using low doses, which will ultimately not be protective. This study clearly shows that half-dose trivalent inactivated vaccine in young healthy women is a rational way to extend vaccine supply in times of critical shortage."
"Although the results of this study are useful and can provide a guide to extending the vaccine supply during periods of shortage, perhaps the real message of this study is that better methods of influenza vaccine production that are less prone to problems are clearly needed," she concludes.
(Arch Intern Med. 2008;168[22]:2402-2403. Available to the media pre-embargo at www.jamamedia.org).
Editor's Note: Please see the article for additional information, including 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 P.M. (CT), MONDAY, December 8, 2008
Media Advisory: To contact Jordi Salas-Salvadó, M.D., Ph.D., e-mail jordi.salas{at}urv.cat.
MEDITERRANEAN DIET PLUS NUTS MAY BE HELPFUL IN MANAGING METABOLIC SYNDROME
CHICAGO—A traditional Mediterranean diet with an additional daily serving of mixed nuts appears to be useful for managing some metabolic abnormalities in older adults at high risk for heart disease, according to a report in the December 8/22 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.
The metabolic syndrome is a set of metabolic abnormalities that includes abdominal obesity and high cholesterol, high blood pressure and high blood glucose levels, all of which are risk factors for cardiovascular disease, according to background information in the article. "Development of the metabolic syndrome depends on a complex interaction between still largely unknown genetic determinants and environmental factors, including dietary patterns," the authors write. A traditional Mediterranean diet—characterized by a high intake of cereals, vegetables, fruits and olive oil, a moderate intake of fish and alcohol and a low intake of dairy, meats and sweets—has been associated with a lower risk for metabolic abnormalities.
Jordi Salas-Salvadó, M.D., Ph.D., of the University of Rovira i Virgili, Spain, and colleagues assessed 1,224 participants in the PREDIMED (Prevencion con Dieta Mediterranea) study who were age 55 to 80 and at high risk for cardiovascular disease. Participants were randomly assigned to one of three groups: one group received advice on a low-fat diet while two received quarterly education about the Mediterranean diet. One of the Mediterranean diet groups was provided with 1 liter per week of virgin olive oil and the other received 30 grams per day of mixed nuts.
At the beginning of the study, 61.4 percent of the participants met criteria for the metabolic syndrome. After one year, 409 participants in the Mediterranean diet plus olive oil group, 411 in the Mediterranean diet plus nuts group and 404 in the control group of low-fat diet advice were available for evaluation. The prevalence of metabolic syndrome decreased by 13.7 percent among those in the nut group, 6.7 percent in the olive oil group and 2 percent in the control group.
Participants' weight did not change over the one-year period. However, the number of individuals with large waist circumference, high triglycerides or high blood pressure significantly decreased in the Mediterranean diet plus nuts group compared with the control group. This suggests that components of the diet, principally the nuts, may have beneficial effects on pathophysiological characteristics of metabolic syndrome, such as oxygen-related cell damage, resistance to the effects of insulin or chronic inflammation. The Mediterranean diet is high in unsaturated fatty acids; in addition, nuts also contain beneficial nutrients such as fiber, arginine, potassium, calcium and magnesium.
"Traditionally, dietary patterns recommended for health have been low-fat, high-carbohydrate diets, which generally are not palatable," the authors conclude. "The results of the present study show that a non-energy-restricted traditional Mediterranean diet enriched with nuts, which is high in fat, high in unsaturated fat and palatable, is a useful tool in managing the metabolic syndrome." A longer follow-up of the PREDIMED study participants may provide stronger evidence of the cardiovascular benefits that could result, they note.
(Arch Intern Med. 2008;168[22]:2449-2458. Available to the media pre-embargo 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 P.M. (CT), MONDAY, December 8, 2008
Media Advisory: To contact Michael A. Fischer, M.D., M.S., call Holly Brown-Ayers at 617-534-1603.
ELECTRONIC PRESCRIBING SYSTEM MAY ENCOURAGE PHYSICIANS TO CHOOSE LOWER-COST DRUGS
CHICAGO—Clinicians using an electronic prescribing system appear more likely to prescribe lower-cost medications, reducing drug spending, according to a report in the December 8/22 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.
"Prescription drug costs account for a significant proportion of medical spending and have been increasing rapidly," the authors write as background information in the article. One method for encouraging use of lower-cost medications is a tiered copayment system. Insurers identify preferred medications, such as generic drugs, and designate them "tier 1" with the lowest copayment. Moderately priced brand-name medications may be designated second-tier and assigned a higher copayment, and third-tier drugs represent expensive brand-name medications for which generic alternatives are available and have the highest copayment.
"A key limitation of tiered copayment systems is prescribers' inability to keep track of differing copayment tiers across insurance plans' formularies," the authors write. Michael A. Fischer, M.D., M.S., of Brigham and Women's Hospital and Harvard Medical School, Boston, studied an electronic prescribing (e-prescribing) system designed to address this issue. In April 2004, two large Massachusetts insurers began using the system, which provided community-based practices with free wireless devices and access to a secure web portal that color-coded drugs by copayment tier. Using 18 months of data, the researchers compared the change in proportion of prescriptions for the three tiers before and after e-prescribing began, and also compared the prescription habits of clinicians using the e-prescribing system to those of controls.
Between October 2003 and March 2005, more than 1.5 million patients filled 17.4 million prescriptions. After implementation of e-prescribing, tier 1 prescriptions increased by 3.3 percent and second- and third-tier prescriptions decreased accordingly among clinicians using the system. E-prescriptions of tier 1 medications increased 6.6 percent, compared with a 2.6 percent increase among prescriptions from the control group.
Among clinicians using the new system, e-prescriptions accounted for 20 percent of prescriptions. These clinicians prescribed more tier-1 medications than the control group even when not e-prescribing; however, prescriptions of lower-cost medications were most common among e-prescriptions.
Based on average medication costs for private insurers, the researchers estimate that using such an e-prescribing system at this rate could result in savings of $0.70 per patient per month, or $845,000 annually per 100,000 insured patients filling prescriptions. "The potential savings increase with more availability and use of e-prescribing; for complete e-prescribing use, the projected savings are $3.91 million per 100,000 patients per year," the authors write.
"Our results suggest that there are important economic gains achievable through the broader use of e-prescribing with formulary decision support but that merely providing e-prescribing systems to clinicians will not necessarily achieve those savings," they conclude. "Rather, prescribers need to adopt the e-prescribing systems fully for these gains to be realized. Making those changes represents an important goal for physicians, insurers and all those with a stake in the cost of prescription medications."
(Arch Intern Med. 2008;168[22]:2433-2439. Available to the media pre-embargo at www.jamamedia.org).
Editor's Note: This study was supported by a grant from the Agency for Healthcare Research and Quality and a career development grant from the National Institutes of Health. 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 P.M. (CT), MONDAY, December 8, 2008
Media Advisory: To contact Brien A. Holden, Ph.D., D.Sc., e-mail b.holden{at}ier.org.au.
AGE-RELATED FARSIGHTEDNESS MAY AFFECT MORE THAN 1 BILLION WORLDWIDE
CHICAGO—It is estimated that more than 1 billion individuals worldwide in 2005 had presbyopia, or age-related difficulty in seeing objects nearby, with an estimated 410 million with the condition unable to perform tasks requiring near vision, according to a report in the December issue of Archives of Ophthalmology, one of the JAMA/Archives journals.
Presbyopia occurs with age, as the eye's lens loses its elasticity and ability to focus on close objects, according to background information in the article. "Although known physiology and population demographics suggest that presbyopia is common or nearly universal in people older than 65 years, direct estimates of prevalence are rare," the authors write. "The total number of people with presbyopia is primarily of interest as a precursor to the figures of greatest public health interest: the number of people with impaired vision due to uncorrected or undercorrected presbyopia and the effect on their lives."
Brien A. Holden, Ph.D., D.Sc., of the University of New South Wales, Sydney, Australia, and colleagues analyzed multiple surveys to estimate the global prevalence of presbyopia, along with the rate at which the condition is corrected and the vision impairment caused when it is not. They then used the International Data Base of the U.S. Census Bureau to extrapolate estimates for the future.
Using projections from these surveys, the researchers estimate that 1.04 billion people globally had presbyopia in 2005, 517 million of whom had no eyeglasses or inadequate eyeglasses or spectacles. Most (386 million, or 94 percent) of the individuals whose daily tasks were impaired by uncorrected presbyopia lived in the developing world.
These estimates are based on the best available information, the authors note. "More epidemiological research in presbyopia is needed to decrease the assumptions and generalizations required for a better global estimate," the authors write. "As more data become available, an increasingly accurate picture of the burden of presbyopia will emerge."
The researchers predict that the worldwide prevalence of presbyopia will increase to 1.4 billion by 2020 and 1.8 billion by 2050. "Without intervention to make spectacles more accessible, the global number of individuals who will have a disability associated with uncorrected presbyopia is predicted to grow to 563 million people by 2020," the authors conclude. "If the goal of Vision 2020 to eliminate unnecessary blindness and impaired vision, in this case due to uncorrected refractive error, is to be achieved, planning will have to include the provision of human resources, affordable spectacles and systems of delivery for these half-billion people in need."
(Arch Ophthalmol. 2008;126[12]:1731-1739. Available to the media pre-embargo at www.jamamedia.org).
Editor's Note: This work was supported by a public health grant from the Institute for Eye Research. 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 P.M. (CT), MONDAY, December 8, 2008
Media Advisory: To contact Jinan B. Saaddine, M.D., M.P.H., call the CDC Division of Media Relations at 404-639-3286.
OCCURRENCE OF MAJOR EYE DISEASE PROJECTED TO INCREASE AMONG PATIENTS WITH DIABETES
CHICAGO—Based on projected increases in the prevalence of diabetes, the number of people with diabetes-related retinal disease, with glaucoma and with cataracts is estimated to increase significantly by 2050, according to a report in the December issue of Archives of Ophthalmology, one of the JAMA/Archives journals.
Diabetic retinopathy (damage to the small blood vessels in the retina) is the leading cause of blindness among American working-age adults with approximately $500 million spent on direct medical costs for diabetic retinopathy in 2004, according to background information in the article. "People with diabetes mellitus also have a higher prevalence of other eye diseases, such as cataracts and glaucoma, than the general population," the authors write. "Vision loss related to eye disease among people with diabetes is an important disability that threatens independence and can lead to depression, reduced mobility and reduced quality of life."
Jinan B. Saaddine, M.D., M.P.H., of the Centers for Disease Control and Prevention, Atlanta, and colleagues used published data from the 2004 National Health Interview Survey and the U.S. Census Bureau to estimate the number, age, sex and race/ethnicity of Americans with diabetes that will have the following eye conditions in the year 2050: diabetic retinopathy, vision threatening diabetic retinopathy, glaucoma and cataracts.
U.S. Census projections suggest that the total U.S. population will reach 402 million in 2050. It is expected that there will be 213 million non-Hispanic whites, 53 million blacks, 98 million Hispanics and 38 million people of other races. Based on these data and the projected increase in diabetes prevalence, the authors estimate that from 2005 to 2050 diabetic retinopathy cases will increase from 5.5 million to 16 million; vision threatening diabetic retinopathy cases will increase from 1.2 million to 3.4 million; increases in diabetic retinopathy and vision threatening diabetic retinopathy among Americans age 65 or older will be more prominent (rising from 2.5 million to 9.9 million for diabetic retinopathy and from 0.5 million to 1.9 million for vision threatening diabetic retinopathy); cataract cases among whites and blacks age 40 or older with diabetes will likely rise 235 percent; cataract cases among people with diabetes age 75 or older will increase 637 percent for black women and 677 percent for black men; and glaucoma cases among Hispanics age 65 or older with diabetes will increase 12-fold.
"In summary, our projections have shown higher numbers than previously estimated for diabetic retinopathy, vision threatening diabetic retinopathy, cataracts and glaucoma among Americans with diabetes," they conclude. "Efforts to prevent diabetes and to optimally manage diabetes and its complications are needed."
(Arch Ophthalmol. 2008;126[12]:1740-1747. Available to the media pre-embargo 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 P.M. (CT), MONDAY, December 8, 2008
Media Advisory: To contact E. Ray Dorsey, M.D., M.B.A., call Mark Michaud at 585-273-4790.
CLINICAL TRIAL PARTICIPANTS VALUE PERSONALIZED, ACCURATE INFORMATION ABOUT STUDY RESULTS
CHICAGO—Participants in clinical trials report being satisfied with personalized, accurate communication of results by study investigators soon after the study findings are released publicly, according to a report in the December issue of Archives of Neurology, one of the JAMA/Archives journals.
Even though volunteers in clinical trials expose themselves to risk, there is no legal mandate for investigators to inform participants of study results, according to background information in the article. However, many researchers have recommended providing both negative and positive clinical trial results as the "ethical norm." "Despite this recommendation, efforts to communicate results to research participants remain quite limited," the authors write. "Some participants never learn study results, although many would like to have that information."
E. Ray Dorsey, M.D., M.B.A., of University of Rochester Medical Center, New York, and colleagues conducted a multi-site randomized clinical trial of an omega-three fatty acid for patients with mild to moderate Huntington's disease. Following the completion of the trial, the researchers implemented a communication plan with three principal elements: a media release from the study investigators, posted online and e-mailed to members of the Huntington's disease community; a telephone call from the site staff to research participants; and a conference call for investigators, sponsor and study participants two weeks after the results were released.
A total of 217 study participants were mailed a survey to assess their satisfaction with the communication of the results; 114 (52.5 percent) responded. "Most (73.1 percent) first learned the study results from their site's telephone call, and 46.3 percent learned the results within one day of the sponsor's press release," the authors write. "Participants reported high or complete satisfaction with the site telephone call (89.3 percent) and conference call (82.1 percent) but relatively low satisfaction with the sponsor's press release (50 percent). Most respondents reported good understanding of the risks and benefits of the experimental treatment and the next steps for their participation."
When asked whether they prefer that results undergo a thorough review before being informed, 59.4 percent agreed, even if it meant a delay in learning about the results. They also reported preferring communications customized to them rather than directed to the public or company investors.
"Communicating research results to participants remains an unmet need that would likely benefit from more planning and cooperation, from addressing the issue prospectively in the consent process, and from using a more evidence-based appraisal of clinical research practices," the authors conclude. "Our study suggests that addressing this need is feasible and highly valued by research participants."
(Arch Neurol. 2008;65[12]:1590-1595. Available to the media pre-embargo at www.jamamedia.org)
Editor's Note: The TREND-HD Study and the communications effort were supported by Amarin Neuroscience Ltd. 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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