A Memory and organizational aid improves alzheimer disease research consent capacity: Results of a randomized, controlled trial

American Journal of Geriatric Psychiatry

Volumn 18, Issue 12, 2010, Pages 1124-1132

  Rubright, Jonathan ^a   Sankar, Pamela ^b,g,h   Casarett, David J ^c,g,h,i,l   Gur, Ruben ^d,e,f,i   Xie, Sharon X ^j,k   Karlawish, Jason ^{b,c,g,h,i,j,k}  

^a UNIVERSITY OF DELAWARE   (United States)

^b Departments of Medical Ethics   (United States)

^c Departments of Preventive Medicine   (United States)

^d Departments of Psychiatry   (United States)

^e Departments of Radiology   (United States)

^f Departments of Neurology   (United States)

^g Center for Bioethics   (United States)

^h Leonard David Institute of Health Economics   (United States)

ⁱ UNIVERSITY OF PENNSYLVANIA   (United States)

^j Department of Biostatistics and Epidemiology ^*  (United States)

^k Alzheimer's Disease Center   (United States)

^l VETERANS AFFAIRS MEDICAL CENTER   (United States)

more..

Author keywords

Alzheimer's disease; capacity; informed consent; research ethics

Indexed keywords

AGED; ALZHEIMER DISEASE; ARTICLE; COGNITION; FEMALE; GROUPS BY AGE; HUMAN; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; MAJOR CLINICAL STUDY; MALE; MEMORY; MENTAL CAPACITY; PSYCHIATRIST; RANDOMIZED CONTROLLED TRIAL; STRUCTURED INTERVIEW;

EID: 79751481236     PISSN: 10647481     EISSN: 15457214     Source Type: Journal    
DOI: 10.1097/JGP.0b013e3181dd1c3b     Document Type: Article

References (43)

1. Hebert LE, Scherr PA, Bienias JL, et al: Alzheimer disease in the US population: prevalence estimates using the 2000 census. Arch Neurol 2003; 60:1119-1122 (Pubitemid 36975801)
2. Gauthier S: Do we have a treatment for Alzheimer Disease? Yes. Arch Neurol 1999; 56:738-739 (Pubitemid 29266477)
3. Pryse-Phillips W. Do we have drugs for dementia? Number. Arch Neurol 1999; 56:735-737
4. Mayeux R, Sano M: Treatment of Alzheimer's disease. N Engl J Med 1999; 341:1670-1679
5. Marson DC, Ingram KK, Cody HA,et al: Assessing the competency of patients with Alzheimer's Disease under different legal standards: a prototype instrument. Arch Neurol 1995; 52:949-954
6. Kim SYH, Caine ED, Currier GW, et al: Assessing the competence of persons with Alzheimer's disease in providing informed consent for participation in research. Am J Psychiatry 2001; 158:710-717
7. Sachs GA, Stocking CB, Stern R, et al: Ethical aspects of dementia research: informed consent and proxy consent. Clin Res 1994; 42:403-412
8. Karlawish JHT, Casarett DJ, James BD: Alzheimers disease patients' and caregivers' capacity, competency and reasons to enroll in an early phase Alzheimers disease clinical trial. J Am Geriatr Soc 2002; 50:2019-2024
9. Palmer BW, Dunn LB, Appelbaum PS, et al: Assessment of capacity to consent to research among older persons with schizophrenia, Alzheimer disease, or diabetes mellitus: comparison of a 3-item questionnaire with a comprehensive standardized capacity instrument. Arch Gen Psychiatry 2005; 62:726-733 (Pubitemid 41002753)
10. Karlawish J, Sachs GA: Research on the cognitively impaired: lessons and warnings from the emergency research debate. J Am Geriatr Soc 1997; 45:474-481 (Pubitemid 27169225)
11. American College of Physicians. Cognitively impaired subjects (Position paper). Ann Intern Med 1989; 111:843-848
12. Fletcher JC, Dommel W Jr, Cowell DD: Consent to research with impaired human subjects. IRB: Rev Hum Subj Res 1985; 7: 1-6
13. Dresser R: Mentally disabled research subjects: the enduring policy issues. JAMA 1996; 276:67-72 (Pubitemid 26231060)
14. Cutler NR, Sramek JJ: Guidelines for conducting bridging studies in Alzheimer Disease. Alzheimer Dis Assoc Disord 1998; 12: 88-92 (Pubitemid 29108215)
15. Sramek JJ, Viereck C, Huff FJ, et al: A "bridging" (safety/tolerance) study of besipirdine hydrochloride in patients with Alzheimer's disease. Life Sci 1995; 57:1241-1248
16. Sramek JJ, Sedman AJ, Reece PA, et al: Safety and tolerability of CI-979 in patients with Alzheimer's disease. Life Sci 1995; 57: 503-510
17. National Institutes of Health. Office of Extramural Research. Research involving individuals with questionable capacity to consent: Points to consider [online]. Available at http://grants.nih. gov/grants/policy/ questionablecapacity.htm. Accessed May 19, 2010
18. National Bioethics Advisory Commission. Research Involving Persons with Mental Disorders that May Affect Their Decision Making Capacity. Vol I: Report and Recommendations. Rockville, MD: US Government Printing Office, 1998
19. Flory J, Emanuel E: Interventions to improve research participants' understanding in informed consent for research: a systematic review. J Am Med Assoc 2004; 292:1593-1601 (Pubitemid 39314966)
20. Stanley B, Stanley M: Competency and informed consent in geriatric psychiatry, in Geriatric Psychiatry and the Law: Critical Issues in American Psychiatry and the Law. Edited by Rosner R, Schwartz HI. New York: Plenum, 1987, pp 17-28
21. Stanley B, Stanley M, Guido J, et al. The functional competency of elderly at risk. Gerontologist 1988; 28 (suppl):53-58
22. Marson D, Harrell L: Executive dysfunction and loss of capacity to consent to medical treatment in patients with Alzheimer's disease. Semin Clin Neuropsychol 1999; 4:41-49
23. Holzer JC, Gansler DA, Moczynski NP, et al: Cognitive functions in the informed consent evaluation process: a pilot study. J Am Acad Psychiatry Law 1997; 25:531-540 (Pubitemid 28073079)
24. Schacter DL: Stories of elders, in Searching for Memory: The Brain, the Mind, and the Past. New York: Basic Books, 1996, pp 280-308
25. Green J: Tests of specific abilities, in Neuropsychological Evaluation of the Older Adult-A Clinician's Guidebook. San Diego, CA: Academic Press, 2000, pp 43-53
26. Graf P, Schacter DL: Implicit and explicit memory for new associations in normal and amnesic subjects. J Exp Psychol Learn Mem Cogn 1985; 11:501-518
27. Karlsson T, Backman L, Herlitz A, et al: Memory improvement at different stages of Alzheimer's disease. Neuropsychologia 1989; 27:737-742 (Pubitemid 19150597)
28. Karlsson T, Johansson I, Adolfsson R, et al: Recognition memory in Alzheimer's disease. A demonstration of a remarkable memory capacity in Alzheimer's disease. Dement Geriatr Cogn Disord 2003; 15:6-9 (Pubitemid 35404256)
29. McKhann G, Drachman D, Folstein M, et al: Clinical diagnosis of Alzheimer's disease. Report of the NINCDS-ADRDA work group under auspices of the Department of Health and Human Services Task Force on Alzheimer's disease. Neurology 1984; 34:939-944 (Pubitemid 14076461)
30. Meinert C, Tonascia S: Randomization and the mechanics of treatment masking, in Clinical Trials: Design, Conduct, and Analysis. New York: Oxford University Press, 1986, pp 90-112
31. Department of Health and Human Services. Common Rule, 45 CFR 46. Federal policy for the protection of human subjects; Notices and rules. Federal Register 1991; 56:28003-28032
32. Appelbaum PS,GrissoT:The MacArthurCompetence Assessment Tool-Clinical Research. Sarasota, FL: Professional Resources Press, 2000
33. Appelbaum PS, Grisso T, Frank E, et al: Competence of depressed patients for consent to research. Am J Psychiatry 1999; 156:1380-1384 (Pubitemid 29416534)
34. Carpenter WT, Gold JM, Lahti AC, et al: Decisional capacity for informed consent in schizophrenia research. Arch Gen Psychiatry 2000; 57:533-538 (Pubitemid 30349432)
35. Kim SY, Caine ED, Currier GW, et al: Assessing the competence of persons with Alzheimer's disease in providing informed consent for participation in research. Am J Psychiatry 2001; 158:712-717 (Pubitemid 32429837)
36. Naglie G, Silberfeld M, O'Rourke K, et al: A randomized trial of a decisional aid for mental capacity assessments. J Clin Epidemiol 1993; 46:221-230 (Pubitemid 23107069)
37. Etchells E, Darzins P, Silberfeld M, et al: Assessment of patient competency to consent to treatment. J Gen Intern Med 1999; 14:27-34 (Pubitemid 29056698)
38. STATA Corporation. Stata User's Guide Release 8. College Station: Stata Press, 2003
39. Hintze J: PASS 2000 User's Guide. Kaysville, Utah, 2000
40. Chow SC, Liu, JP: Design and Analysis of Clinical Trials- Concepts and Methodologies. New York: Wiley, 1998
41. Cohen J: Statistical Power Analysis for the Behavioral Sciences, 2nd ed. Hillsdale, NJ: Lawrence Erlbaum Associates, 1988
42. Grisso T, Appelbaum PS, Mulvey EP, et al: The MacArthur Treatment Competence Study. II. Law Hum Behav 1995; 19: 127-148
43. Kim SY, Karlawish JH, Caine ED: Current state of research on decision-making competence of cognitively impaired elderly persons. Am J Geriatr Psychiatry 2002; 10:151-165 (Pubitemid 34685627)