title: External validity of randomized controlled trials in older adults, a systematic review.
abstract: BACKGROUND
  To critically assess the external validity of randomized controlled trials (RCTs) it is important to know what older adults have been enrolled in the trials. The aim of this systematic review is to study what proportion of trials specifically designed for older patients report on somatic status, physical and mental functioning, social environment and frailty in the patient characteristics.
  
  
  METHODS
  PubMed was searched for articles published in 2012 and only RCTs were included. Articles were further excluded if not conducted with humans or only secondary analyses were reported. A random sample of 10% was drawn. The current review analyzed this random sample and further selected trials when the reported mean age was ≥ 60 years. We extracted geriatric assessments from the population descriptives or the in- and exclusion criteria.
  
  
  RESULTS
  In total 1396 trials were analyzed and 300 trials included. The median of the reported mean age was 66 (IQR 63-70) and the median percentage of men in the trials was 60 (IQR 45-72). In 34% of the RCTs specifically designed for older patients somatic status, physical and mental functioning, social environment or frailty were reported in the population descriptives or the in- and exclusion criteria. Physical and mental functioning was reported most frequently (22% and 14%). When selecting RCTs on a mean age of 70 or 80 years the report of geriatric assessments in the patient characteristics was 46% and 85% respectively but represent only 5% and 1% of the trials.
  
  
  CONCLUSIONS
  Somatic status, physical and mental functioning, social environment and frailty are underreported even in RCTs specifically designed for older patients published in 2012. Therefore, it is unclear for clinicians to which older patients the results can be applied. We recommend systematic to transparently report these relevant characteristics of older participants included in RCTs.
authors.affiliation: Department of Gerontology and Geriatrics, Leiden University Medical Centre, Leiden, The Netherlands.
authors.forename: Floor J
authors.initials: FJ
authors.lastname: van Deudekom
authors.affiliation: Department of Gerontology and Geriatrics, Leiden University Medical Centre, Leiden, The Netherlands.|Institute for Evidence-Based Medicine in Old Age (IEMO), Leiden, The Netherlands.
authors.forename: Iris
authors.initials: I
authors.lastname: Postmus
authors.affiliation: Department of Gerontology and Geriatrics, Leiden University Medical Centre, Leiden, The Netherlands.
authors.forename: Danielle J
authors.initials: DJ
authors.lastname: van der Ham
authors.affiliation: Institute for Evidence-Based Medicine in Old Age (IEMO), Leiden, The Netherlands.|Division of Vascular and Endovascular Surgery, Department of Surgery, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America.
authors.forename: Alexander B
authors.initials: AB
authors.lastname: Pothof
authors.affiliation: Department of Gerontology and Geriatrics, Leiden University Medical Centre, Leiden, The Netherlands.
authors.forename: Karen
authors.initials: K
authors.lastname: Broekhuizen
authors.affiliation: Department of Gerontology and Geriatrics, Leiden University Medical Centre, Leiden, The Netherlands.
authors.forename: Gerard J
authors.initials: GJ
authors.lastname: Blauw
authors.affiliation: Department of Gerontology and Geriatrics, Leiden University Medical Centre, Leiden, The Netherlands.|Institute for Evidence-Based Medicine in Old Age (IEMO), Leiden, The Netherlands.
authors.forename: Simon P
authors.initials: SP
authors.lastname: Mooijaart
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000375:Aging; D005260:Female; D016330:Frail Elderly; D015577:Geriatric Assessment / Q000379:methods*; D006801:Humans; D008297:Male; D016743:Mental Competency; D008875:Middle Aged; D010809:Physical Fitness; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012931:Social Environment