The COMBINE SAFTEE: a structured instrument for collecting adverse events adapted for clinical studies in the alcoholism field.
OBJECTIVE
In the many clinical studies conducted in the alcoholism field with psychotropic drugs--and throughout the drug development field in medicine, where evaluation of adverse events can be incomplete, arbitrary or misleading--few standardized methods have been developed for assessing adverse events, whereas defining standardized methods for evaluating clinical efficacy is typical. For the National Institute on Alcohol Abuse and Alcoholism COMBINE Study, testing the safety and efficacy of naltrexone and acamprosate, both alone and in combination, in the treatment of alcohol dependence, we adapted a standardized instrument--the Systematic Assessment for Treatment Emergent Events (SAFTEE)--for assessing adverse events in these Phase 2- to Phase 3-type studies.


METHODS
We standardized use of the SAFTEE with training, supervision and clear guidelines for its implementation, including development of a nomenclature for the typical adverse events associated with these medications and a format for examining symptom severity. Data from the COMBINE SAFTEE include not only frequency of adverse events but also severity level and a composite index taking into account both the severity and duration of symptoms.


RESULTS
The COMBINE SAFTEE was incorporated into the Medical Management therapy and showed high fidelity with its utility, consistency of deliverability and flexibility in measuring adverse events in both the human laboratory and clinical trial settings using intervals that varied from daily to weekly use.


CONCLUSIONS
Due to its high standardization level, the COMBINE SAFTEE could be incorporated into other brief compliance enhancement strategies in clinical studies to assess the efficacy of putative therapeutic drugs.
Johnson
Bankole A
BA
Department of Psychiatric Medicine, University of Virginia, P.O. Box 800623, Charlottesville, Virginia 22908-0623, USA. bankolejohnson@virginia.edu
Ait-Daoud
Nassima
N
Roache
John D
JD
D000077443:Acamprosate; D000427:Alcohol Deterrents / Q000009:adverse effects / Q000627:therapeutic use*; D000437:Alcoholism / Q000188:drug therapy / Q000453:epidemiology / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000592:standards*; D016903:Drug Monitoring / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions; D017408:Guidelines as Topic; D006282:Health Personnel / Q000193:education*; D006801:Humans; D009271:Naltrexone / Q000009:adverse effects / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D015588:Observer Variation; D011795:Surveys and Questionnaires; D013654:Taurine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D009626:Terminology as Topic
D000427:Alcohol Deterrents; D009292:Narcotic Antagonists; D013654:Taurine; D009271:Naltrexone; D000077443:Acamprosate