View Entire Collection
By Clinical Topic
By State Requirement
Diabetes – Summer 2012
Future of Nursing Initiative
Heart Failure - Fall 2011
Influenza - Winter 2011
Nursing Ethics - Fall 2011
Trauma - Fall 2010
Traumatic Brain Injury - Fall 2010
Fluids & Electrolytes
FRIDAY, Sept. 4 (HealthDay News) -- Many orthopedic randomized clinical trials do not properly follow the intention-to-treat principle, potentially producing bias in trial results and analyses, according to a report in the Sept. 1 Journal of Bone & Joint Surgery.
Amir Herman, M.D., of Chaim Sheba Medical Center in Ramat-Gan, Israel, and colleagues reviewed eight orthopedic journals for the years 2005 to 2008 and identified articles on 274 clinical trials in orthopedics. The reviewers assessed the studies to determine if they observed the intention-to-treat principle, in which study results are analyzed depending on the subjects' original treatment cohort, regardless of treatment ultimately used. In particular, the reviewers assessed methods employed to account for missing data.
The researchers report that 96 of the 274 clinical trials claimed to employ the intention-to-treat principle, but adherence to the precise definition of the principle was found in just 45 of the 96. In 44 of the 96 trials, patients lost to follow-up were not included in the final analysis, in contravention of the intention-to-treat principle. The most conspicuous violation of the principle was in studies of surgical interventions, while the most common method of adjustment for missing data was the technique of "last observation carried forward."
"In most of the randomized clinical trials published in the orthopedic literature, the investigators did not adhere to the stringent use of the intention-to-treat principle, with the most conspicuous problem being a lack of accounting for patients lost to follow-up. This omission might introduce bias to orthopedic randomized clinical trials and their analysis," the authors write.
Full Text (subscription or payment may be required)
Sign up for our free enewsletters to stay up-to-date in your area of practice - or take a look at an archive of prior issues
Join our CESaver program to earn up to 100 contact hours for only $34.95
Explore a world of online resources
Back to Top