Our purpose is to compare the General and Specific Forms of SAFTEE (Systematic Assessment for Treatment Emergent Events) to determine whether clinically useful information is generated by the Specific form beyond that obtained with the General form. We will evaluate the 2 forms regarding inter-rater reliability, various forms of validity and other psychometric characteristics, using summary scores that we will design. We will administer both General and Specific SAFTEE forms on 2 occasions; at pretreatment baseline and after 6 weeks of medication trails. Using regressed change scores we will contrast the 2 forms, the ratings on each by psychiatrist vs. research nurse; the response of patients on active vs. placebo medication. Sets of predictor variables including patient personal and demographic characteristics, illness and treatment characteristics, and other parameters, will be related to reported side effects. During 18 months of data collection, 400 patients will be assessed. Three hundred will be adults with various types and severity of affective and anxiety disorders treated with marketed and investigational antidepressants and anxiolytics, the large majority on an outpatient basis. One hundred will be children. Of these, half will be outpatients with major depressive disorder, and the balance inpatients with disorders treated with neuroleptics, stimulants and antidepressants. All adults will be participating in standardized clinical drug trials, the majority with a randomized double-blind design including a placebo comparison group. Most children will be treated openly according to a standard protocol, although some will participate in randomized clinical trials. Patients will be drawn from 5 participating clinical services within New York State Psychiatric Institute. The 3 adult services are the Depression Evaluation Service, the Anxiety Disorders Clinic (outpatient) and Clinical Psychopharmacology Unit (both outpatient and inpatient). The Child services include the Child/Adolescent Depression Clinic and Inpatient Child Unit. SAFTEE raters in each of the 5 services will include both psychiatrists and research nurses to whom patients will be randomly assigned for assessments. This will enble a comparison of ratings made by the two professional groups in terms of reliability and clinical utility of information they record.
| Rabkin, J G; Markowitz, J S; Ocepek-Welikson, K et al. (1992) General versus systematic inquiry about emergent clinical events with SAFTEE: implications for clinical research. J Clin Psychopharmacol 12:3-10 |
