Intervention research in psychosis: Issues related to clinical assessment

This article discusses efforts to optimize clinical assessment for interven tion effectiveness trials. Generalizability is a crucial issue; investigato rs should choose their inclusion/exclusion criteria to increase subject inc lusion and should collect data on the selection process to determine the ex tent of selection biases. Intervention research requires assessment instrum ents appropriate for a variety of treatment settings. We describe the Hills ide Clinical Trials version of the Scale for the Assessment of Negative Sym ptoms, which has inpatient and outpatient versions to accommodate the diffe rent opportunities for social interaction in these settings. Lack of unifor mity in assessment instruments complicates interpretation of results across studies and impedes communication of findings. We describe the 5-Dimension al Scale to Evaluate Psychopathology in Schizophrenia (5-STEPS), a collabor ative effort to develop a standard change measure for schizophrenia treatme nt trials. We also discuss potential future strategies, including developin g briefer yet reliable and valid diagnostic procedures, making trials more acceptable in a broad range of settings through the use of open-label treat ment with blinded independent assessors, bridging efficacy and effectivenes s designs by studying both a narrow efficacy and a broader effectiveness po pulation simultaneously, and updating outcome domains to reflect current tr eatment strategies.