title: Underrepresentation of patients with pre-existing cognitive impairment in pharmaceutical trials on prophylactic or therapeutic treatments for delirium: a systematic review.
abstract: OBJECTIVE
  Representation of hospitalized patients with pre-existing cognitive impairment in pharmaceutical delirium trials is important because these patients are at high risk for developing delirium. The aim of this systematic review is to investigate whether patients with cognitive impairment were included in studies on pharmacological prophylaxis or treatment of delirium and to explore the motivations for their exclusion (if they were excluded).
  
  
  METHODS
  This study was a systematic review. A MEDLINE search was performed for publications dated from 1 January 1985 to 15 November 2012. Randomized and non-randomized controlled trials that investigated medication to prevent or treat delirium were included. The number of patients with cognitive impairment was counted, and if they were excluded, motivations were noted.
  
  
  RESULTS
  The search yielded 4293 hits, ultimately resulting in 31 studies that met the inclusion criteria. Of these, five studies explicitly mentioned the percentage of patients with cognitive impairment that were included. These patients comprised a total of 8% (n = 279 patients) of the 3476 patients included in all 31 studies. Ten studies might have included cognitively impaired patients but did not mention the exact percentage, and sixteen studies excluded all patients with cognitive impairment. The motivations for exclusion varied, but most were related to the influence of dementia on delirium.
  
  
  CONCLUSIONS
  The exclusion of patients with pre-existing cognitive impairment hampers the generalizability of the results of these trials and leaves clinicians with limited evidence about the pharmacological treatment of this group of vulnerable patients who have an increased risk of side effects.
authors: Department of Internal Medicine, Geriatrics Section, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. Electronic address: a.dejonghe@amc.uva.nl.
authors: Annemarieke
authors: A
authors: de Jonghe
authors: Department of Internal Medicine, Geriatrics Section, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
authors: Esther M M
authors: EM
authors: van de Glind
authors: Department of Internal Medicine, Geriatrics Section, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands; Department of Geriatrics, Albert Schweitzerlaan 31, 7334 DZ Gelre Hospitals, Apeldoorn, The Netherlands.
authors: Barbara C
authors: BC
authors: van Munster
authors: Department of Internal Medicine, Geriatrics Section, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
authors: Sophia E
authors: SE
authors: de Rooij
mesh_terms: D000368:Aged; D003072:Cognition Disorders / Q000150:complications*; D018849:Controlled Clinical Trials as Topic; D003693:Delirium / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D016032:Randomized Controlled Trials as Topic
keywords: Cognitive impairment; Delirium; Dementia; Prophylaxis; Treatment; Trials; Underrepresentation