Long-term neuroleptic treatment with risperidone - methodology of a drug utilization observation study using the PANSS

Phase IV research evaluates drugs under routine treatment conditions. This allows to assess positive and negative drug effects in the context of prescription behavior and, by this, is a measure of quality assurance in medicine. The "Alpha-Project" is a drug utilization observation study on neuroleptic treatment in schizophrenia. In line with the guidelines of the AGNP a study protocol describes study goals, procedures and methods. This allows similar studies to use the same methodology which can help to improve the scientific standards in this research field. One pivotal instrument is the PANSS. It could be shown that in this field study this scale had the same factor structure as in the original publication which speaks for the validity of ratings by physicians working in routine care.