Another study finds many clinical trials change study design outcomes without explanation
WEDNESDAY, Nov. 11 (HealthDay News) -- The cost of providing data and support for health system quality-improvement programs can put a significant burden on primary care practices, and changes in the outcomes of trials are often made without being disclosed, according to two studies in the November/December Annals of Family Medicine.
Jacqueline R. Halladay, M.D., of the University of North Carolina at Chapel Hill, and colleagues collected information from eight diverse primary care practices in North Carolina on the costs of participating in four quality-reporting programs. The researchers found that costs to the practices in personnel time, training, registry maintenance, and other program components ranged from less than $1,000 to $11,100 during program implementation and from less than $100 to $4,300 annually.
In the other study, Robert Ewart, M.D., of the Southern Illinois University School of Medicine in Springfield, and colleagues examined the frequency of changes without explanation in clinical trial primary and secondary outcomes. They compared randomized clinical trials from consecutive issues of five medical journals over a six-month period against their respective trial registry entries and found that in 31 percent of trials a primary outcome was changed, and in 70 percent a secondary outcome was changed.
"There are substantial and important undisclosed changes made to the outcomes of published randomized controlled trials between trial registration and publication. This finding has important implications for the interpretation of trial results. Disclosure and discussion of changes would improve transparency in the performance and reporting of trials," Ewart and colleagues conclude.
Abstract - Halladay
Abstract - Ewart