Challenges in operationalizing the DSM-IV clinical significance criterion.

BACKGROUND An explicit clinical significance (CS) criterion was added to many DSM-IV diagnoses in an attempt to more closely approximate the clinical diagnostic process and reduce the proportion of false positives in epidemiological studies. The American Indian Service Utilization, Psychiatric Epidemiology, Risk and Protective Factors Project (AI-SUPERPFP) offered a unique opportunity to examine the success of this effort. OBJECTIVE To determine the impact of distress, impairment, and help-seeking reported in a lay structured interview on concordance with a clinical reappraisal. Further, to test the efficacy of 5 operationalizations of CS on the concordance and prevalence of DSM-IV lifetime disorders. DESIGN Completed between 1997 and 2000, a cross-sectional probability sample survey with clinical reappraisal of approximately 10% of participants. SETTING General community. PARTICIPANTS A population-based sample of 3084 members of 2 American Indian tribal groups, who were between the ages of 15 and 54 years and resided on or near their home reservations, were randomly sampled from the tribal rolls and participated in structured psychiatric interviews. Clinical reappraisals were conducted with approximately 10% of the lay-interview participants. The response rate for the lay interview was 75%, and for the clinical reappraisal it was 72%. MAIN OUTCOMES MEASURES The AI-SUPERPFP Composite International Diagnostic Interview (CIDI), a culturally adapted version of the CIDI, University of Michigan version. Adapted to assess DSM-IV diagnoses, questions assessing the CS criterion were inserted in all diagnostic modules. The Structured Clinical Interview for DSM-III-R (SCID) was used in the clinical reappraisal. RESULTS Most participants who qualified as having AI-SUPERPFP CIDI lifetime disorders reported at least moderate levels of distress or impairment. Evidence of increased concordance between the CIDI and the SCID was lacking when more restrictive operationalizations of CS were used; indeed, the CIDI was very likely to underdiagnose disorders compared with the SCID (false negatives). Concomitantly, the CS operationalizations affected prevalence rates dramatically. CONCLUSION The CS criterion, at least as operationalized to date, demonstrates little effectiveness in increasing the validity of diagnoses using lay-administered structured interviews.