The Journal of Bone and Joint Surgery (American). 2007;89:1693-1699.
doi:10.2106/JBJS.F.00858
© 2007 The Journal of Bone and Joint Surgery, Inc.
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Quality of Prospective Controlled Randomized Trials

Analysis of Trials of Treatment for Lateral Epicondylitis as an Example

James Cowan, BA1, Santiago Lozano-Calderón, MD1 and David Ring, MD, PhD1

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).

Background: The Oxford Levels of Evidence are now routinely assigned at many orthopaedic journals. One disadvantage of this approach is that study designs with a higher level of evidence may be given greater weight than the overall quality of the study merits. In other words, there is no guarantee that research is scientifically valid simply because a more sophisticated study design was employed. The aim of this study was to review Level-I and II therapeutic studies on lateral epicondylitis to measure variation in quality among the highest-level study designs.

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 ({kappa} = 0.73, p < 0.01), the modified Coleman Methodology Score ({kappa} = 0.73; p < 0.01), and the CONSORT score ({kappa} = 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.


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Letters to the Editor:

Read all Letters to the Editor

Quality assessment of RCT reports
Rudolf W. Poolman MD PhD, et al.
JBJS Online, 24 Sep 2007 [Full text]
Dr. Ring responds to Drs. Poolman and Bhandari
David Ring, M.D.
JBJS Online, 27 Sep 2007 [Full text]
Unititled
Austin L. Leahy, MCH, FRCS, FRCSI
JBJS Online, 3 Oct 2007 [Full text]
Dr. Ring et al. respond to Dr. Leahy
David C. Ring, M.D., et al.
JBJS Online, 3 Oct 2007 [Full text]