OCCURRENCE OF MAJOR EYE DISEASE PROJECTED TO INCREASE A...

OCCURRENCE OF MAJOR EYE DISEASE PROJECTED TO INCREASE AMONG PATIENTS WITH DIABETES

OCCURRENCE OF MAJOR EYE DISEASE PROJECTED TO INCREASE AMONG PATIENTS WITH DIABETES
December 8, 2008
Jinan B. Saaddine, M.D., M.P.H
JAMA For the Media

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@jama-archives.org.

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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.