Background. Very elderly subjects (VES; aged 80 years or older) constitute a special population as they frequently present multiple diseases (polypathology). Results from trials on general adult populations therefore cannot be extrapolated to VES. We performed a census of randomized controlled trials (RCT) on VES published between 1990 and 2002, and carried out a descriptive and methodological analysis of these RCT/VES, comparing them with matched RCT on general adult populations (control RCT, RCT/C). Methods. We searched for RCT/VES in two international databases (EMBASE and MEDLINE) and then manually. RCT/C were matched to RCT/VES for disease area and year of publication. The methodological quality of each RCT was assessed with Chalmers' scale. Results. We identified 84 RCT/VES, 63 of which were conclusive and 21, inconclusive. Subjects were institutionalized in 48 RCT, and community dwelling in 11 RCT (unspecified in 25 RCT). Efficacy was the main criterion in 75 RCT; tolerance in 9 RCT. Twenty-six RCT were published by geriatrics journals, and 58 by general medical journals. The RCT/VES covered most of the disease areas of geriatrics. The 84 RCT/VES had a mean methodological quality score of 0.578 ± 0.157. The matched 84 RCT/C had a mean methodological quality score of 0.592 ± 0.116 (p = .466). The methodological quality score of RCT/VES increased with the number of included subjects (p = .004) and the year of publication (p = .001). Conclusions. The methodological quality of RCT/VES is equivalent to that of RCT in general adult populations. Nevertheless, RCT/VES remain very scarce, and neglect certain diseases. RCT/VES and the inclusion of very elderly subjects in RCT on adults should be strongly encouraged. Copyright 2005 by The Gerontological Society of America.
CITATION STYLE
Le Quintrec, J. L., Bussy, C., Golmard, J. L., Hervé, C., Baulon, A., & Piette, F. (2005). Randomized controlled drug trials on very elderly subjects: Descriptive and methodological analysis of trials published between 1990 and 2002 and comparison with trials on adults. Journals of Gerontology - Series A Biological Sciences and Medical Sciences, 60(3), 340–344. https://doi.org/10.1093/gerona/60.3.340
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