A COMPARISON OF DEMOGRAPHIC-VARIABLES, SYMPTOM PROFILES, AND MEASUREMENTS OF FUNCTIONING IN SYMPTOMATIC VOLUNTEERS AND AN OUTPATIENT CLINICAL POPULATION

There is consistent concern about the generalizability of research fin dings generated by clinical trials. There are several reasons for conc ern about these findings: (1) most clinical trials involve symptomatic volunteers who are recruited by means of advertisements rather than p atients recruited from general clinical populations; (2) most clinical trials have restrictive criteria for admission into the study; and (3 ) the design of mast trials is not representative of prescribing pract ices in the community, These methodological issues require investigato rs to question whether re suits from trials adequately model what will be seen in a general clinical situation. This report begins to evalua te the representativeness of initial samples by studying the demograph ic characteristics, symptom profiles, and measurements of functional d isability for clinical outpatients and symptomatic volunteers recruite d for clinical trials. We found that symptomatic volunteers were stati stically more likely to be older than outpatients, were less likely to be single, and reported using more alcohol and cigarettes than outpat ients. The two groups had similar levels of functional impairment and similar ages at onset of symptoms, but symptomatic volunteers reported more symptoms of depression and anxiety than outpatients. However, we believe the differences identified in this study did not seem to be c linically significant.