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A COMPARISON OF METHODS FOR THE ASCERTAINMENT OF ADVERSE DRUG REACTIONS OF ANTIDEPRESSANT MEDICATION. N Diazgranados1, R Mago21. National Institute of Mental Health, Bethesda, MD.2 Thomas Jefferson University, Philadelphia, PA
Methods to evaluate safety of medications are significantly underdeveloped compared to those for efficacy. We designed a patient-rated questionnaire that would assess the likelihood that symptoms reported in a checklist are adverse drug reactions. Patients who had started or increased the dose of an antidepressant in the preceding 3 months were enrolled. For each symptom reported in a check list; the “Patient Rated Inventory of Side Effects” (PRISE), the research subjects completed our “Scale for Assessment of Side-effects” (SAS). As a reference we used the judgment of a physician, which was based on a detailed interview and included a clinician-rating scale the “Adverse Drug Reaction Probability Scale” (ADRPS). The symptoms endorsed in the PRISE were classified as ‘true adverse drug reactions’ or ‘non-medication-related’ by the SAS and the physician; and the results were compared. We enrolled 31 patients, aged 22–67 (median 40) years. On open-ended questioning about side effects, patients reported a median of 2 symptoms (range 0–6). On the PRISE, a median of 7 symptoms (range 2–14) were endorsed. Of 228 symptoms reported with the PRISE, the physician classified 33.8% of them as ‘true adverse drug reactions’. The open-ended question identified 42.8% of symptoms classified as ‘true adverse drug reactions’ by the physician. The SAS had a sensitivity of 92.2% and specificity of 72.8% when compared to the physician’s judgment. It was rated ‘very easy’ or ‘easy’ to fill out by 74.4% patients, and 80% were ‘somewhat willing’ or ‘very willing’ to be assessed with it prior to doctor visits. The SAS is intended to precede, not replace a physician interview, and could make the assessment more manageable and accurate.
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