General versus systematic inquiry about emergent clinical events with SAFTEE: implications for clinical research.

This study compares two methods for elicitation of treatment-emergent side effects. One is the open-ended general inquiry and the other is a specific inquiry that asks about a wide range of events thought to be treatment-related. The study goal was to determine the extent to which the specific inquiry method elicits clinically useful information over and above that elicited by the general inquiry method. The assessment instrument we used is SAFTEE, a structured interview schedule developed by the National Institute of Mental Health. We looked for differences between general and specific inquiry formats in terms of number of events elicited, type of event, severity, functional impairment, and clinician action taken. We found that both methods contributed to elicitation of events that, in the clinician's opinion, required some change in management. However, events reported on the General Inquiry form were significantly more distressing, more often interfered with daily functioning, and elicited more extensive changes in clinical management. No medically serious events were elicited on the specific inquiry form alone. Based on these findings, and in view of the amount of time and effort required to administer and score it, we do not recommend the specific inquiry form of SAFTEE as a standard assessment tool for routine use in all clinical trials. We do consider it to be a useful method for comprehensive elicitation about treatment-emergent effects in targeted and specific research contexts. We see the schedule as a comprehensive document or library of queries to be tailored to the needs of individual protocols.