This Article Full Text Full Text (PDF) [Supplementary Material] Letters to the Editor: Submit a response Letters to the Editor: View responses Alert me when this article is cited Alert me when Letters to the Editor are posted Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to My File Cabinet Download to citation manager Reprints and Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Cowan, J. Articles by Ring, D. Search for Related Content PubMed PubMed Citation Articles by Cowan, J. Articles by Ring, D. Social Bookmarking             What's this?

Quality of Prospective Controlled Randomized Trials

Analysis of Trials of Treatment for Lateral Epicondylitis as an Example

¹ Orthopaedic Hand and Upper Extremity Service, Massachusetts General Hospital, Yawkey Center 2100, 55 Fruit Street, Boston, MA 02114. E-mail address for D. Ring: dring{at}partners.org

Investigation performed at the Orthopaedic Hand and Upper Extremity Service, Massachusetts General Hospital, Boston, Massachusetts

Disclosure: In support of their research for or preparation of this work, one or more of the authors received, in any one year, outside funding or grants in excess of $10,000 from the AO Foundation, Small Bone Innovations, Wright Medical, Joint Active Systems, and Smith and Nephew. 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.

A commentary is available with the electronic versions of this article, on our web site (www.jbjs.org) and on our quarterly CD-ROM (call our subscription department, at 781-449-9780, to order the CD-ROM).

Methods: Fifty-four prospective randomized therapeutic trials involving patients with lateral epicondylitis were evaluated by two independent reviewers according to the Oxford Levels of Evidence, a modification of the Coleman Methodology Score (a 0 to 100-point scale), and the revised CONSORT (Consolidated Standards of Reporting Trials) score.

Results: The two reviewers were consistent in their use of the Oxford Levels of Evidence ( = 0.73, p < 0.01), the modified Coleman Methodology Score ( = 0.73; p < 0.01), and the CONSORT score ( = 0.53; p < 0.01). Both reviewers rated the majority of studies as Level II (91% and 94%) and as unsatisfactory according to the Coleman Methodology Score (87% and 89%) and the CONSORT score (62% and 63%). Areas of deficiency included poor descriptions of recruitment (>90% of the trials), power-level calculations (73%), randomization (58%), blinding (90%), and participant flow (50%) as well as inadequate follow-up, sample size, and blinding.

Conclusions: The use of the gold-standard trial design, the prospective randomized therapeutic study (Level-I or II evidence), does not ensure quality research or reporting. Critical analysis of scientific work is important regardless of the study design. Clinical scientists should be familiar with the CONSORT criteria and adhere to them when reporting clinical trials.

CiteULike    Connotea    Del.icio.us    Technorati    What's this?

Letters to the Editor:

Stanford University Libraries' HighWire Press (TM) assists in the publication of JBJS Online.
Copyright © 2007 by The Journal of Bone and Joint Surgery, Inc. Online ISSN: 1535-1386.
The Journal of Bone and Joint Surgery®, JBJS®, JB&JS®, and eJBJS® are registered in the U.S. Patent and Trademark Office.