Objective: A major change in DSM-IV is the inclusion in almost one-half of the diagnostic criteria sets of a clinical significance criterion, which requires that symptoms cause "clinically significant distress or impairment in social, occupational, or other important areas of functioning." In response to concerns that the DSM criteria are overly inclusive, the clinical significance criterion attempts to minimize false positive diagnoses in situations in which the symptom criteria do not necessarily indicate pathology. This article examines whether the clinical significance criterion achieves its purpose and considers its broader impact on diagnostic validity.

Method: The effect of the clinical significance criterion on the diagnostic validity of DSM-IV criteria for a wide range of disorders was examined.

Results: For many diagnoses to which the clinical significance criterion was added, the symptom criteria are inherently associated with significant impairment, so the clinical significance criterion is redundant and therefore does not affect caseness. For some diagnoses, the clinical significance criterion is potentially helpful in eliminating false positives by elevating the level of required distress. However, there may be advantages to obtaining the same results by modifying some of the symptom criteria. Often the clinical significance criterion has led to the possibility of false negative diagnoses.

Conclusions: In the process of revising DSM-IV, the generic use of the clinical significance criterion should be reconsidered. For each DSM diagnosis, it should be determined whether there is a need to raise the threshold of any of the existing symptom criteria or to add a criterion that excludes normal reactions to psychosocial stress.