PMID: 8582306Dec 1, 1995Paper

DSM IV and research. The problem of clinical trials

L'Encéphale
P Boyer

Abstract

Like its predecessors, DSM IV allows the prospective study population for clinical trials to be defined as accurately possible. The inclusion and exclusion criteria allow clear definition of the diagnostic category to which patients belong, and the simplest way of allowing the clinician to find his way through the criteria under consideration is to place the latter in a "checklist". The clinician then checks whether or not a given criterion is present, and after completing the checklist calculates whether the checked criteria are sufficient to warrant inclusion of a given patient. This approach, though methodical nevertheless, contains a significant drawback. The diagnostic criteria of DSM IV are at once "positive" (symptoms which a patient must present to qualify for inclusion in a diagnostic category) and "negative" (symptoms which the patient must not present in order to qualify for inclusion). In some cases it is relatively simple to establish the existence of such negative criteria (e.g. cases in which it must be ascertained that symptoms are due neither to ingestion of a toxic substance nor to recent bereavement). However, very often these negative symptoms are not presented one by one in the list of criteria, but are ins...Continue Reading

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