TO THE EDITOR:
The article "Closed Fractures of the Tibial Shaft. A Meta-Analysis of Three Methods of Treatment" (80-A: 174—183, Feb. 1998), by Littenberg et al., compared treatment with immobilization in a cast, open reduction and internal fixation, and fixation with an intramedullary rod for closed fractures of the tibial shaft. Previously published reports dealing with tibial fractures were included in, or excluded from, the meta-analysis on the basis of a list of inclusion and exclusion criteria. Among the exclusion criteria were injuries involving a joint, patients with multiple injuries, and open fractures of the tibial shaft if the results of open and closed fractures were not defined separately. The authors started with 2372 papers and, from these, gleaned nineteen that fulfilled their criteria.
In my opinion, this paper has so many deficiencies that it is meaningless. These deficiencies include the basic premise that one method of treatment will provide the best outcome; the grouping together of papers that were written over a span of a half-century (including one paper4, a 770-word abstract of a presentation given to the British Orthopaedic Society in 1973, that is considerably shorter than this letter); and the grouping together of papers that were written with an emphasis that was entirely different from that of the meta-analysis (for example, the word infection cannot be found in the paper by Sarmiento5).
These criticisms are merely my opinion. However, it is a fact that the authors have not followed their own inclusion-exclusion criteria. The report by Sarmiento clearly includes two patients who had an associated injury of a joint: one patient had a fracture of the medial malleolus in association with a distal tibial fracture, and the other had extension of a proximal fracture into the knee (Figs. 9-A and 16)5. The study by Johner and Wruhs clearly includes a fracture extending into the ankle (Figs. 5-A and 5-B)2. Both of these studies were included in the meta-analysis despite the fact that they included patients who had injuries involving a joint, thus violating one of the exclusion criteria. The study by Johner and Wruhs includes 116 patients with multiple injuries, thereby violating another of the exclusion criteria. The report by Klemm and Börner includes ninety-three open fractures of the tibia3; although the rate of infection is reported separately for open and closed fractures (in the Discussion section), the rates of nonunion and reoperation are not. This violates the exclusion criteria because the results of open and closed fractures are not defined separately. Because the authors have not followed their own inclusion-exclusion criteria, their conclusions are meaningless.
I find the publication of this paper in The Journal particularly ironic considering the content of the lead editorial in the same issue1. In that editorial, entitled "Ethics of Medical Authorship," Cowell states that "the ethical way demands that the author read the entire article, not just the abstract."
Clayton R. Perry, M.D.: Department of Orthopaedic Surgery, St. Louis University School of Medicine, U.S. Center for Sports Medicine, 333 South Kirkwood Road, St. Louis, Missouri 63122
Dr. Littenberg, Dr. Weinstein, Dr. McCarren, Mr. Mead, Dr. Swiontkowski, Dr. Rudicel, and Dr. Heck reply:
We thank Dr. Perry for affording us the opportunity to explain the meaning of our work. The point was not to indicate which one treatment is best but rather to identify the limits of the data on which clinical practice is currently based.
Dr. Perry is correct that many important outcomes and covariates were not assessed in the orthopaedic literature. We presented what was found after a thorough search, limitations and all. He is also correct that many reports combine unlike patients in clinically unrealistic ways. Although imperfect, these studies are the best that the literature has to offer the practicing surgeon. We included some larger series that had a small number of ineligible patients. To exclude them would have left very few analyzable reports. In other cases, when the reports allowed, we excluded the patients who had polytrauma and joint involvement and analyzed only the patients who were fully eligible. The detailed criteria for these actions were explicit in our research protocol but were excluded from the final published report.
Our report should not be read as an attempt to prescribe orthopaedic practice. Rather, it is an indictment of an inadequate knowledge base. The published literature on tibial fractures is seriously flawed. Orthopaedic surgeons are forced to make crucial treatment decisions without any reasonable understanding of the track record of the treatments available. Patients must be managed with techniques that, despite their having been in wide use for many years, have never been rigorously evaluated. We, and the patients whom we serve, need well designed, controlled, randomized, blinded, adequately powered clinical trials in order to answer basic questions regarding the effectiveness of treatments for both common and rare clinical conditions. Fortunately, some agencies (such as the Orthopaedic Research and Education Foundation and the National Institutes of Health) are beginning to use these basic scientific criteria to help to prioritize the funding of clinical research.
Benjamin Littenberg, M.D.: Division of General Medical Sciences, Washington University School of Medicine, 660 South Euclid Avenue, Campus Box 8005, St. Louis, Missouri 63110
Loryn P. Weinstein, M.D.: Department of Orthopedics, Mayo Clinic, 200 First Street S.W., Rochester, Minnesota 55905
Madeline McCarren, Ph.D.: Center for Health Services Research, M/C 922, University of Illinois, 2121 West Taylor Street, Chicago, Illinois 60612
Thomas Mead, M.L.S.: Dana Biomedical Library, 6168 Dartmouth College, Hanover, New Hampshire 03755
Marc F. Swiontkowski, M.D.: Department of Orthopedics, University of Minnesota, 420 Delaware Street, Box 492, Minneapolis, Minnesota 55455
Sally A. Rudicel, M.D.: Department of Orthopaedics, New England Medical Center, 750 Washington Street, P.O. Box 306, Boston, Massachusetts 02111
David Heck, M.D.: Indiana University, 541 Clinical Drive, Suite 600, Indianapolis, Indiana 46202