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The Journal of Bone and Joint Surgery, Vol 70, Issue 9 1357-1364, Copyright © 1988 by Journal of Bone and Joint Surgery, Inc
Orthopaedic clinical research. Deficiencies in experimental design and determinations of outcome
JJ Gartland
Jefferson Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania 19107.
The validity of the designs of some published orthopaedic clinical-research
studies has been questioned. It has also been suggested that such studies
should focus more on the outcome in terms of the health of the patients
rather than primarily on procedural or technical concerns. To test the
validity of these criticisms, ten published reports on the surgical
treatment of patients who had a selected diagnosis were reviewed to
evaluate the strategies that had been used in the design of the study and
the outcome in terms of the patient's health. Ten articles on the long-term
follow-up of patients after primary total hip arthroplasty for the
treatment of osteoarthritis, published in peer-reviewed journals, were
examined to determine the strategies that had been used in the design of
each study and the methods of reporting the outcomes. All ten articles were
found to be deficient in terms of design, to be flawed by confusing data,
and to contain results of doubtful validity. The emphasis in the reported
outcomes was predominantly on the status of the prosthetic device instead
of on the health of the patients in whom the prosthetic device had been
used. Authors, journals, program committees, and professional societies
must share the blame for the publication of flawed studies that are
designed using inappropriate strategies. In the future, reports on
orthopaedic clinical research must focus more on the health of and the
economic benefits to the patients and less on the outcome of the technology
that was used in providing the services.
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