Site variability in a multisite geriatric depression trial
G.W. Small
Bok Engelsk 1996
| Utgitt | 1996
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| Omfang | 6 s.
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| Opplysninger | We studied differences in outcome and characteristics among 29clinical sites of a multisite, double-blind antidepressant trial forgeriatric depression. Six hundred and seventy-one outpatients aged 60years or order (mean +/- SD = 67.7 +/- 5.7) met DSM-III-R criteriafor unipolar major depression, had baseline 17-item HamiltonDepression Rating Scale (HAMD(17)) scores greater than or equal to 16and were randomized to fluoxetine (20 mg dairy) or placebo. Effectsizes (ESs, expressed as mean differences between effects divided bythe pooled standard deviation of the differences) were calculated foreach site using selected outcome measures. ES ranged from 1.84(favoring fluoxetine) to -0.91 (favoring placebo) for incidence ofremitters (endpoint HAMD(17) total score of less than or equal to 8).A large, positive ES favoring fluoxetine for remission rates (ESgreater than or equal to 0.65) was found at only six sites, moderateES (0.35-0.64) at eight and small ES (0-0.34) at seven; ES favoredplacebo (< 0) at eight of 29 sites. Private clinics showed an overallHAMD(17) ES for change scores more than twice that of universitysites. These results suggest that individual practitioners may havevastly different clinical experiences in large, multisite trials forgeriatric depression. Interrater reliability, subject selection,recruitment, inadequate or fixed dosing, few patients per site, briefstudy duration, heterogeneity of geriatric depression, financialincentive and characteristics of individual sites may contribute toresponse variability.
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