SYMPOSIUM

CONDUCTING MULTI-CENTER STUDIES

Jones, L.C. and Hungerford, D.S.
Johns Hopkins University School of Medicine;
Department of Orthopaedic Surgery; Baltimore, MD

The need for multicenter studies for the investigation of the pathogenesis and treatment of osteonecrosis is indisputable. No one center has enough patients to conduct a definitive study concerning the epidemiology, the relationships between all of the associated etiological agents and the pathogenesis of the disease, and the treatment of patients with diverse etiologic associations and disease progression. However, the conduct of multicenter studies is fraught with problems: including inaccurate and incomplete data collection, using different tools to measure outcome, using different classifications systems, using different patient cohorts, and the use of different treatment regimens.

One necessity for any multicenter study is the development of a user-friendly, but robust, database. In 1995, we began to develop questionnaires and forms in order to identify the type of information that we would like to collect. No question was off limits. A comprehensive list of questions was gathered and forms were generated. These forms underwent a trial use in a suburban clinic and found to be too time consuming and cumbersome to complete during a physician-led interview with the patient. The questionnaires were sent to a group of interested surgeons in the United States. They were asked to review the questions and to determine which questions were "essential", "desired", or "unnecessary". In addition, questions were separated into those that needed to be asked by the medical staff and those that could be answered alone. A new set of forms has been generated and a database constructed based upon these findings. In a trial in 2000, 555 patients were entered into the database, associated with 5 different physicians from three different centers. The most significant source of difficulty was that forms were frequently incomplete.

The future will likely involve using a web-based site documentation center. There are issues of confidentiality, personnel time, electronic validation and redundancy problems, and quality control. These challenges need to be met in order to advance our knowledge in this field.