Publication of Clinical Trials
Marc F. Swiontkowski, MD

The Journal of Bone and Joint Surgery (JBJS) began as the Transactions of the American Orthopedic Association with the publication of that association's annual meeting proceedings of 1887 and 1888. Volume XVI of the Transactions of the American Orthopedic Association became Volume I of the American Journal of Orthopedic Surgery, and in 1919, when the Journal became the official publication of the British Orthopaedic Association as well, the word American was dropped and the spelling of Orthopedic was corrected to Orthopaedic. In 1948, the American and British volumes were established. Throughout its long history, the major goal of The Journal of Bone and Joint Surgery has been to improve the quality of the information on which the practice of orthopaedic surgery is based.

Our masthead contains the mission statement: “excellence through peer review.” Five years ago, we became the first musculoskeletal research journal to routinely report levels of evidence of clinical research studies. The basis for this decision was the desire to increase the knowledge base of the orthopaedic community regarding the quality of clinical research design and how it should impact decisions surrounding patient care. The number of controlled trials published in JBJS continues to increase1, and publication of high-quality major randomized controlled trials is a top priority.

In recent years, we have published a substantial number of major randomized controlled trials that have immediately impacted clinical practice. Although observational studies (Level III and Level IV) and systematic reviews (Level II) remain extremely valuable sources of clinical information, randomized controlled trials remain at the top of the hierarchy of evidence. The Instructions to Authors published in this journal each month include detailed information about preparation and submission of scientific manuscripts; many aspects of the instructions are pertinent for clinical trials. Features related solely to randomized controlled trials are emphasized in this editorial.

Effective January 1, 2009, JBJS-Am will require, as a condition of consideration for publication, that all randomized controlled trials be registered in a public trials registry acceptable to the International Committee of Medical Journal Editors (ICMJE)2,3. Clinical trials for which patient enrollment began after July 2005 should have been registered before the onset of patient enrollment. JBJS-Am requires registration of all randomized controlled trials in which human subjects are randomized to an intervention, not just those trials involving drugs or devices subject to provisions of the U.S. Food and Drug Administration (FDA) Federal Food, Drug, and Cosmetic Act, recently amended in 20074. A part of the editorial review may include an evaluation of the registration information posted regarding the trial to determine if the a priori outcomes reported in the manuscript are the same as those originally proposed.

In addition, authors of clinical trials should follow the CONSORT (Consolidated Standards of Reporting Trials) guidelines for reporting the results of randomized controlled trials, including the submission of a detailed patient flow diagram5. The primary results must be based on an intention-to-treat analysis, including an accounting for all randomized patients and, if necessary, use of appropriate methods to account for missing data. The intention-to-treat analysis must be reported as the primary analysis.

JBJS-Am understands that this approach involves additional effort and expense. However, this requirement also has marked benefits for the orthopaedic community. A short list of these benefits includes a decreased perception of bias, limitation of conflict of interest, and an improvement in the potential generalizability of the results. JBJS-Am is following the lead of JAMA (Journal of the American Medical Association), which implemented these requirements in 20056.

In 2008, JBJS-Am instituted a process of independent statistical analysis of clinical trials as well as comparative cohort studies to ensure its readership that the scientific work included appropriate statistical evaluation and reporting7. This review includes a determination of the appropriateness of the prespecified data analysis plan. As a part of the review of a clinical trial or other research manuscript, the Editor of JBJS-Am may request the entire data set to allow a complete assessment of the analyses that were conducted. During the planning phase of a clinical trial, the Editor is available to direct inquiries regarding the design of clinical trials and the analysis of clinical trial data to the experts who conduct the statistical reviews for JBJS.

We believe that these changes will continue to improve the quality of information on which orthopaedic surgeons and their colleagues base their clinical decisions, which was the original goal of The Journal of Bone and Joint Surgery.

Footnotes

  • Disclosure: The author did not receive any outside funding or grants in support of his research for or preparation of this work. Neither he nor a member of his immediate family 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 author, or a member of his immediate family, is affiliated or associated.

References

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