On the process for evaluating proposed new diagnostic EEG tests.

Assessment of new technology is an important part of the evolving art of medicine. For a variety of reasons, it is appropriate to restrict clinical applications of new technology to those tests which have been shown to be safe and effective. Efficacy of new EEG technology can be assessed through a variety of standard procedures, generally based on controlled, well organized clinical studies. Scientific reports using new EEG technology all too often fail to meet the standards traditionally expected for such clinical trials. Many such studies were never designed to be clinical trials. Misunderstandings occur when reports of scientific studies and informal clinical series become confused with formal clinical trials of efficacy. Based upon examples given during the 1991 ISBET meeting symposium on discriminant analysis, examples are discussed regarding how well individual kinds of presentations can be used to help clarify the generic clinical efficacy of the presented diagnostic tests.