The proposed research will provide scientific data about the reliability, validity and characteristics of use of a newly developed technique for rating adverse drug reactions: the Systematic Assessment for Treatment Emergent Events (SAFTEE). Each of two levels of elicitation of adverse events available for use with SAFTEE will be evaluated. Both levels will be assessed in comparison to each other as well as to standard side effect rating scales being used in ongoing Phase II and III clinical psychopharmacology trials. This will enable an evaluation of SAFTEE under a variety of conditions of use including populations differing on diagnosis, use of raters of different disciplines, and a wide sampling of psychotropic agents. The measurement of the adverse effects of drug treatment has received little methodologic consideration in clinical trials of psychotropic drugs. Improvement in the sensitivity, reliability and validity of the measurement of adverse drug reactions (ADRs) will provide greater protection for patients from toxic compounds, provide comparison data on the side effects of psychotropic drugs to facilitate their clinical use, and improve the quality of clinical trials across multicenter trials. Procedures will be developed to train the various members of our research team in the use of SAFTEE and investigate whether multiple-rater agreement can be obtained on the actual occurrances of ADRs. The use of SAFTEE will then be added to the assessment procedures in a wide range of clinical trials and the inter-rater reliability of SAFTEE will be measured. The validity of SAFTEE will be determined by (1) measuring its ability to distinguish active drug from placebo, (2) evaluating dose-response relationships found in the various clinical trials, (3) its abilitiy to differentiate the side effect profiles of different classes of drugs, and (4) comparing the results of SAFTEE with those obtained with other side effect assessment instruments.
| Jacobson, A F; Goldstein, B J; Dominguez, R A et al. (1987) Interrater agreement and reliability measures of SAFTEE: general inquiry vs. systematic inquiry. Psychopharmacol Bull 23:97-101 |
