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Orthopaedic clinical research. Deficiencies in experimental design and determinations of outcome

The Journal of Bone & Joint Surgery.  1988; 70:1357-1364 
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Abstract

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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    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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