title: 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.
abstract: 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.
authors.affiliation: Service de Gérontologie I, Hôpital Sainte-Périne/Rossini, 11, rue Chardon Lagache, F 75016 Paris, France. muriel.palomares@spr.ap-hop-paris.fr
authors.forename: Jean-Laurent
authors.initials: JL
authors.lastname: Le Quintrec
authors.forename: Caroline
authors.initials: C
authors.lastname: Bussy
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Golmard
authors.forename: Christian
authors.initials: C
authors.lastname: Hervé
authors.forename: Alain
authors.initials: A
authors.lastname: Baulon
authors.forename: François
authors.initials: F
authors.lastname: Piette
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D003695:Delivery of Health Care / Q000706:statistics & numerical data; D004361:Drug Tolerance; D004363:Drug Utilization / Q000706:statistics & numerical data; D005260:Female; D005602:France; D005853:Geriatrics / Q000706:statistics & numerical data*; D006299:Health Services for the Aged / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D012016:Reference Values; D012107:Research Design / Q000592:standards / Q000706:statistics & numerical data; D016896:Treatment Outcome
chemical_list: D004364:Pharmaceutical Preparations