title: A memory and organizational aid improves Alzheimer disease research consent capacity: results of a randomized, controlled trial.
abstract: OBJECTIVE
  Early and progressive cognitive impairments of patients with Alzheimer disease (AD) hinder their capacity to provide informed consent. Unfortunately, the limited research on techniques to improve capacity has shown mixed results. Therefore, the authors tested whether a memory and organizational aid improves the performance of patients with AD on measures of capacity and competency to give informed consent.
  
  
  METHODS
  Patients with AD randomly assigned to standard consent or standard plus a memory and organizational aid.
  
  
  METHODS
  Memory and organizational aid summarized the content of information mandated under the informed consent disclosure requirements of the Common Rule at a sixth grade reading level.
  
  
  METHODS
  Three psychiatrists without access to patient data independently reviewed MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) interview transcripts to judge whether the patient was capable of providing informed consent. The agreement of at least two of the three experts defined a participant as capable of providing informed consent. Secondary outcomes are MacCAT-CR measures of understanding, appreciation and reasoning, and comparison with cognitively normal older adult norms.
  
  
  RESULTS
  AD intervention and control groups were similar in terms of age, education, and cognitive status. The intervention group was more likely to be judged competent than control group and had higher scores on MacCAT-CR measure of understanding. The intervention had no effect on the measures of appreciation or reasoning.
  
  
  CONCLUSIONS
  A consent process that addresses the deficits in memory and attention of a patient with AD can improve capacity to give informed consent for early phase AD research. The results also validate the MacCAT-CR as an instrument to measure capacity, especially the understanding subscale.
  
  
  BACKGROUND
  ClinicalTrials.Gov#NCT00105612, http://clinicaltrials.gov/show/NCT00105612.
authors.affiliation: Delaware Education Research and Development Center, University of Delaware School of Education, Newark, USA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Rubright
authors.forename: Pamela
authors.initials: P
authors.lastname: Sankar
authors.forename: David J
authors.initials: DJ
authors.lastname: Casarett
authors.forename: Ruben
authors.initials: R
authors.lastname: Gur
authors.forename: Sharon X
authors.initials: SX
authors.lastname: Xie
authors.forename: Jason
authors.initials: J
authors.lastname: Karlawish
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000523:psychology*; D003657:Decision Making; D005260:Female; D015577:Geriatric Assessment / Q000379:methods; D006801:Humans; D007258:Informed Consent / Q000523:psychology*; D008297:Male; D008569:Memory Disorders / Q000523:psychology*; D016743:Mental Competency / Q000523:psychology*; D008875:Middle Aged; D035842:Research Subjects / Q000523:psychology*
references.citation: JAMA. 1996 Jul 3;276(1):67-72
references.pmid: 8667543
references.citation: Ann Intern Med. 1989 Nov 15;111(10):843-8
references.pmid: 2683918
references.citation: Semin Clin Neuropsychiatry. 1999 Jan;4(1):41-9
references.pmid: 10229792
references.citation: Life Sci. 1995;57(12):1241-8
references.pmid: 7674813
references.citation: Arch Gen Psychiatry. 2000 Jun;57(6):533-8
references.pmid: 10839330
references.citation: Clin Res. 1994 Oct;42(3):403-12
references.pmid: 7955902
references.citation: J Am Acad Psychiatry Law. 1997;25(4):531-40
references.pmid: 9460039
references.citation: IRB. 1985 Nov-Dec;7(6):1-6
references.pmid: 11649686
references.citation: Arch Neurol. 1995 Oct;52(10):949-54
references.pmid: 7575221
references.citation: N Engl J Med. 1999 Nov 25;341(22):1670-9
references.pmid: 10572156
references.citation: J Am Geriatr Soc. 2002 Dec;50(12):2019-24
references.pmid: 12473015
references.citation: Arch Neurol. 1999 Jun;56(6):735-7
references.pmid: 10369315
references.citation: JAMA. 2004 Oct 6;292(13):1593-601
references.pmid: 15467062
references.citation: J Exp Psychol Learn Mem Cogn. 1985 Jul;11(3):501-18
references.pmid: 3160813
references.citation: Am J Geriatr Psychiatry. 2002 Mar-Apr;10(2):151-65
references.pmid: 11925276
references.citation: Am J Psychiatry. 2001 May;158(5):712-7
references.pmid: 11329391
references.citation: Life Sci. 1995;57(5):503-10
references.pmid: 7623616
references.citation: Arch Neurol. 2003 Aug;60(8):1119-22
references.pmid: 12925369
references.citation: J Am Geriatr Soc. 1997 Apr;45(4):474-81
references.pmid: 9100718
references.citation: J Clin Epidemiol. 1993 Mar;46(3):221-30
references.pmid: 8455046
references.citation: Arch Gen Psychiatry. 2005 Jul;62(7):726-33
references.pmid: 15997013
references.citation: Gerontologist. 1988 Jun;28 Suppl:53-8
references.pmid: 3169594
references.citation: Law Hum Behav. 1995 Apr;19(2):127-48
references.pmid: 11660291
references.citation: Alzheimer Dis Assoc Disord. 1998 Jun;12(2):88-92
references.pmid: 9651137
references.citation: J Gen Intern Med. 1999 Jan;14(1):27-34
references.pmid: 9893088
references.citation: Dement Geriatr Cogn Disord. 2003;15(1):6-9
references.pmid: 12457073
references.citation: Neurology. 1984 Jul;34(7):939-44
references.pmid: 6610841
references.citation: Am J Psychiatry. 1999 Sep;156(9):1380-4
references.pmid: 10484948
references.citation: Arch Neurol. 1999 Jun;56(6):738-9
references.pmid: 10369316
references.citation: Neuropsychologia. 1989;27(5):737-42
references.pmid: 2739896
references.citation: Fed Regist. 1991 Jun 18;56(117):28003-18
references.pmid: 10112214