How were the SPORT Trial Participants Selected?
Before a trial is started, it and its methods must be approved by the sponsoring organization—in this case the National Institutes of Health—and by an Internal Review Board (IRB), made up of health care professionals and others not affiliated with the trial itself. Finally, a data safety monitoring board oversees the trial, constantly reviewing the results and information being gathered. This board can step in and stop a trial at any time if it appears the treatment isn't helping the patients involved.
In this trial, people in each of the categories being looked at had to meet very specific criteria before being considered eligible for the study. They had to have a common set of symptoms and diagnoses to make sure the comparisons would be accurate. They also could not have any symptoms or conditions that might cause the trial to be harmful to their health. They could not be in obvious, immediate need of surgery. A full list of the criteria, as well as a detailed discussion of the methodology, is available in a paper called Design of SPORT (PDF). This study also lists the kinds of non-surgical therapies studied.
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