Featured Research

from universities, journals, and other organizations

Most Ongoing Diabetes Trials Do Not Include Outcomes Important To Patients

Date:
June 3, 2008
Source:
JAMA and Archives Journals
Summary:
An analysis of ongoing randomized clinical trials (RCTs) in diabetes finds that only about 20 percent have as primary outcomes results that patients consider important, such as illness, pain, effect on function and death, according to a new study.

An analysis of ongoing randomized clinical trials (RCTs) in diabetes finds that only about 20 percent have as primary outcomes results that patients consider important, such as illness, pain, effect on function and death, according to a new study. Concerns about the safety and efficacy of diabetes interventions continue, in part because RCTs have not measured their effect on patient-important outcomes as quality of life and death, according to background information in the article. "Are future diabetes trials likely to be more informative to patients and clinicians?" the researchers ask.

Gunjan Y. Gandhi, M.D., M.Sc., and M. Hassan Murad, M.D., M.P.H., of Mayo Clinic, Rochester, Minn., and colleagues examined large public clinical trial registries to systematically determine the extent to which ongoing and future registered RCTs plan to measure patient-important outcomes in patients with diabetes. The researchers identified phase 2 through 4 RCTs enrolling patients with diabetes. Of 2,019 RCTs, 1,054 proved eligible, and 50 percent of these (527) were randomly sampled, and 436 trials registered since registration became mandatory in 2004 were selected. Of these, 6 percent (24) had not started enrollment, 25 percent (109) were actively enrolling, and 69 percent (303) had completed enrollment.

Reviewers collected study characteristics and determined the outcomes measured and their type (physiological outcomes [insulin, C-peptide levels], surrogate outcomes thought to reflect an increased risk for patient-important outcomes [such as cholesterol levels, worsening kidney function], and patient-important outcomes [illness, pain, function and death]).

The researchers found that primary outcomes were patient-important outcomes in 18 percent of the RCTs, physiological and laboratory outcomes in 16 percent, and surrogate outcomes in 61 percent of the 436 RCTs. Patient-important outcomes were reported as primary or secondary outcomes in 46 percent of the RCTs.

Independent predictors of patient-important outcomes were larger trial size and longer trial duration while trials of patients with type 2 diabetes were significantly less likely to report patient-important outcomes as a primary outcome. For primary and secondary outcomes, predictors of patient-important outcomes were trial length and trial phase (phase 3 or 4 vs. phase 2), with trials of patients with type 2 diabetes significantly less likely to report patient-important outcomes.

The authors write, "... the importance of our findings is that (1) without pooling, the individual diabetes trials will largely fail in providing information about the effect of interventions on patient-important outcomes; and (2) trials that are planning to measure patient-important outcomes as secondary end points need to overcome the temptation to selectively report outcomes with statistically significant results as well as to report these findings transparently and carefully. Journals also may need to publish the less-than-interesting results to enable meta-analyses of these results to produce precise enough estimates that can guide practice.

"We believe the time has come for a broad consensus on a standard set of important outcomes for patients in diabetes trials, similar to the Outcome Measures in Rheumatology (OMERACT) initiative. The OMERACT approach allows for the uniform measurement of outcomes in RCTs with emphasis on outcomes that experts--and ultimately patients--thought would better capture the experience of rheumatological conditions."


Story Source:

The above story is based on materials provided by JAMA and Archives Journals. Note: Materials may be edited for content and length.


Journal Reference:

  1. Gunjan Y. Gandhi; M. Hassan Murad; Akira Fujiyoshi; Rebecca J. Mullan; David N. Flynn; Mohamed B. Elamin; Brian A. Swiglo; William L. Isley; Gordon H. Guyatt; Victor M. Montori. Patient-Important Outcomes in Registered Diabetes Trials. JAMA, 2008;299(21):2543-2549

Cite This Page:

JAMA and Archives Journals. "Most Ongoing Diabetes Trials Do Not Include Outcomes Important To Patients." ScienceDaily. ScienceDaily, 3 June 2008. <www.sciencedaily.com/releases/2008/06/080603164356.htm>.
JAMA and Archives Journals. (2008, June 3). Most Ongoing Diabetes Trials Do Not Include Outcomes Important To Patients. ScienceDaily. Retrieved April 19, 2014 from www.sciencedaily.com/releases/2008/06/080603164356.htm
JAMA and Archives Journals. "Most Ongoing Diabetes Trials Do Not Include Outcomes Important To Patients." ScienceDaily. www.sciencedaily.com/releases/2008/06/080603164356.htm (accessed April 19, 2014).

Share This



More Health & Medicine News

Saturday, April 19, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

'Holy Grail' Of Weight Loss? New Find Could Be It

'Holy Grail' Of Weight Loss? New Find Could Be It

Newsy (Apr. 18, 2014) In a potential breakthrough for future obesity treatments, scientists have used MRI scans to pinpoint brown fat in a living adult for the first time. Video provided by Newsy
Powered by NewsLook.com
Little Progress Made In Fighting Food Poisoning, CDC Says

Little Progress Made In Fighting Food Poisoning, CDC Says

Newsy (Apr. 18, 2014) A new report shows rates of two foodborne infections increased in the U.S. in recent years, while salmonella actually dropped 9 percent. Video provided by Newsy
Powered by NewsLook.com
Scientists Create Stem Cells From Adult Skin Cells

Scientists Create Stem Cells From Adult Skin Cells

Newsy (Apr. 17, 2014) The breakthrough could mean a cure for some serious diseases and even the possibility of human cloning, but it's all still a way off. Video provided by Newsy
Powered by NewsLook.com
Obama: 8 Million Healthcare Signups

Obama: 8 Million Healthcare Signups

AP (Apr. 17, 2014) President Barack Obama gave a briefing Thursday announcing 8 million people have signed up under the Affordable Care Act. He blasted continued Republican efforts to repeal the law. (April 17) Video provided by AP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins