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.