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

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.