The Journal of Bone and Joint Surgery (American). 2009;91:2137-2143.
doi:10.2106/JBJS.H.01481
© 2009 The Journal of Bone and Joint Surgery, Inc.
This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow CME: Take the activity for this article:
 CME 3: July, August, September 2009 (publication date October 5, 2009; expi...
Right arrow Letters to the Editor: Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when Letters to the Editor are posted
Right arrow Alert me if a correction is posted
Services
Right arrow E-mail this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My File Cabinet
Right arrow Download to citation manager
Right arrow Rights and Permissions
Google Scholar
Right arrow Articles by Herman, A.
Right arrow Articles by Chechick, A.
PubMed
Right arrow PubMed Citation
Right arrow Articles by Herman, A.
Right arrow Articles by Chechick, A.
Related Collections
Right arrow Adult Trauma
Right arrow Spine
Right arrow Adult Hip
Right arrow Adult Knee
Right arrow Foot/Ankle
Right arrow Shoulder
Right arrow Elbow
Right arrow Hand/Wrist
Right arrow Sports
Right arrow Pediatrics
Right arrow Oncology
Right arrow Rehabilitation
Right arrow Education and Training
Right arrow Pain Management
Right arrow Ethics
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us   Add to Facebook   Add to Technorati   Add to Twitter  
What's this?

Intention-to-Treat Analysis and Accounting for Missing Data in Orthopaedic Randomized Clinical Trials

Amir Herman, MD, MSc1, Itamar Busheri Botser, MD1, Shay Tenenbaum, MD1 and Ahron Chechick, MD1

1 Department of Orthopedic Surgery, Chaim Sheba Medical Center, Ramat-Gan 52621, Israel. E-mail address for A. Herman: amirherm{at}gmail.com

Investigation performed at the Department of Orthopedic Surgery, Chaim Sheba Medical Center, Ramat-Gan, Israel

Disclosure: The authors did not receive any outside funding or grants in support of their research for or preparation of this work. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.

Background: The intention-to-treat principle implies that all patients who are randomized in a clinical trial should be analyzed according to their original allocation. This means that patients crossing over to another treatment group and patients lost to follow-up should be included in the analysis as a part of their original group. This principle is important for preserving the randomization scheme, which is the basis for correct inference in any randomized trial. In this study, we examined the use of the intention-to-treat principle in recently published orthopaedic clinical trials.

Methods: We surveyed eight leading orthopaedic journals for randomized clinical trials published between January 2005 and August 2008. We determined whether the intention-to-treat principle was implemented and, if so, how it was used in each trial. Specifically, we ascertained which methods were used to account for missing data.

Results: Our search yielded 274 randomized clinical trials, and the intention-to-treat principle was used in ninety-six (35%) of them. There were significant differences among the journals with regard to the use of the intention-to-treat principle. The relative number of trials in which the principle was used increased each year. The authors adhered to the strict definition of the intention-to-treat principle in forty-five of the ninety-six studies in which it was claimed that this principle had been used. In forty-four randomized trials, patients who had been lost to follow-up were excluded from the final analysis; this practice was most notable in studies of surgical interventions. The most popular method of adjusting for missing data was the "last observation carried forward" technique.

Conclusions: In most of the randomized clinical trials published in the orthopaedic 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 orthopaedic randomized clinical trials and their analysis.


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us   Add to Facebook Facebook   Add to Technorati Technorati   Add to Twitter Twitter    What's this?