title: The informed consent process in older patients who developed delirium: a clinical epidemiologic study.
abstract: OBJECTIVE
  Delirium, defined as an acute, fluctuating disorder of attention and cognition, is a serious and increasingly common problem for hospitalized older persons. Delirium poses unique ethical challenges for the informed consent process, notably the preservation of patient autonomy in the face of potentially fluctuating decision-making capacity. To clarify these issues, we examined the informed consent process in a group of hospitalized older patients who developed delirium.
  
  
  METHODS
  Eighty-four hospitalized patients aged >70 years who developed delirium during hospitalization at a large urban teaching hospital.
  
  
  METHODS
  We conducted a clinical epidemiologic investigation of informed consent in 173 medical and surgical procedures performed in 84 patients. Clinical researchers carried out detailed cognitive evaluation of patients on or near the consent date. A separate blinded researcher extracted medical record information on the procedures and informed consent process variables.
  
  
  RESULTS
  Of 173 procedures, 33 (19%) had no documentation of any consent, and 34 (20%) used surrogate consent. There were no documented assessments of competency/ decisional capacity; cognitive assessments were done in 7 (4%) cases, and legal consults in 2 (1%) cases. Discussion of potential risks of the procedure with patient or surrogate were documented in 61 (35%) cases. In multivariable analysis, independent predictors for failure to obtain consent were presence of delirium (adjusted odds ratio [OR] = 2.7, 95% confidence interval [CI] 1.3, 5.3) and less invasive procedure (OR = 5.0, CI 2.0, 12.8). Although cognitive impairment predicted surrogate use, we found that 47% of cases with substantial impairment did not involve use of a surrogate, whereas surrogates signed for 4% of cases with normal mental status near the time of consent.
  
  
  CONCLUSIONS
  Our results highlight the ethical challenges that delirium poses for the informed consent process, including the high rate of no consent, lack of cognitive and decisional capacity assessment, and inconsistent surrogate use.
authors.affiliation: Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut 06504, USA.
authors.forename: K B
authors.initials: KB
authors.lastname: Auerswald
authors.forename: P A
authors.initials: PA
authors.lastname: Charpentier
authors.forename: S K
authors.initials: SK
authors.lastname: Inouye
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003071:Cognition; D003693:Delirium / Q000523:psychology; D005260:Female; D006760:Hospitalization; D006801:Humans; D007258:Informed Consent; D008297:Male; D015999:Multivariate Analysis; D016017:Odds Ratio; D011237:Predictive Value of Tests; D012720:Severity of Illness Index