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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

¹ Service de Gérontologie I, Hôpital Sainte Périne/Rossini, Paris, France.
² Service de Gérontologie 3, Hôpital C. Foix, Ivry sur Seine, France.
³ Département de Biostatistiques, Faculté Pitié-Salpetrière, Paris, France.
⁴ Laboratoire d'Ethique Médicale, Université Paris 5, France.
⁵ Service de Médecine Interne, Hôpital C. Foix, Ivry sur Seine, France.

Address correspondence to Jean-Laurent Le Quintrec, Hôpital Sainte-Périne/Rossini, Service de Gérontologie I, 11, rue Chardon Lagache, F 75016 Paris, France. E-mail: muriel.palomares{at}spr.ap-hop-paris.fr

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.