Deliberating clinical research with cognitively impaired older people and their relatives: An ethical add-on study to the protocol "effects of temporary Discontinuation of Antihypertensive Treatment in the Elderly (DANTE) with cognitive impairment"

American Journal of Geriatric Psychiatry

Volumn 22, Issue 11, 2014, Pages 1233-1240

  Van Rookhuijzen, Arendina E ^a   Touwen, Dorothea P ^a   De Ruijter, Wouter ^a   Engberts, Dick P ^a   Van Der Mast, Roos C ^a  

^a LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

Clinical research; decision making; decision making capacity; family; mild cognitive impairment; research participation; surrogate decision making

Indexed keywords

AGED; ARTICLE; AUDIO RECORDING; CLINICAL ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); DECISION MAKING; FEMALE; HUMAN; INFORMED CONSENT; INTERVIEW; MALE; MILD COGNITIVE IMPAIRMENT; MINI MENTAL STATE EXAMINATION; OBSERVATIONAL STUDY; PROFESSIONAL PRACTICE; QUALITATIVE RESEARCH; RISK; VIDEORECORDING; ETHICS; FAMILY; MENTAL CAPACITY; MOTIVATION; PSYCHOLOGY; RESEARCH SUBJECT;

ANTIHYPERTENSIVE AGENT;

AGED; ANTIHYPERTENSIVE AGENTS; CLINICAL TRIALS AS TOPIC; DECISION MAKING; FAMILY; FEMALE; HUMANS; INTERVIEWS AS TOPIC; MALE; MENTAL COMPETENCY; MILD COGNITIVE IMPAIRMENT; MOTIVATION; QUALITATIVE RESEARCH; RESEARCH SUBJECTS;

EID: 84927974926     PISSN: 10647481     EISSN: 15457214     Source Type: Journal    
DOI: 10.1016/j.jagp.2013.04.005     Document Type: Article

References (27)

1. Touwen DP: Voor een ander. Beslissingsverantwoordelijkheden in De verpleeghuisgeneeskunde. Amsterdam, Aksant, 2008
2. Karlawish JH, Rubright J, Casarett D, et al: Older adults' attitudes toward enrollment of non-competent subjects participating in Alzheimer's research. Am J Psychiatry 2009; 166:182-188
3. Karlawish JH, Casarett DJ, James BD: Alzheimer's disease patients' and caregivers' capacity, competency and reasons to enroll in an early-phase Alzheimer's disease clinical trial. Am J Geriatr Soc 2002; 50:2019-2024
4. Kim SY, Cox C, Caine ED: Impaired decision-making ability in subjects with Alzheimer's disease and willingness to participate in research. Am J Psychiatry 2002; 159:797-802
5. Jefferson AL, Carmona H, Gifford KA, et al: Clinical research risk assessment among individuals with mild cognitive impairment. Am J Geriatr Psychiatry 2012; 20:878-886
6. Overton E, Appelbaum PS, Fischer SR, et al: Alternative decisionmakers' perspectives on assent and dissent for dementia research. Am J Geriatr Psychiatry 2013; 21:346-354
7. Van Delden H, et al: Ethiek en empirie. Theorie en methodologie Van empirisch ethisch onderzoek. Maastricht, Caphri/NOW, 2005
8. Borry P, Schotsmans P, Dierickx K: What is the role of empirical research in bioethical reflection and decision-making? An ethical analysis. Med Health Care Philos 2004; 7:41-53
9. Richardson HS: Specifying, balancing, and interpreting bioethical principles. J Med Philos 2000; 25:285-307
10. Sugarman J, Cain C, Wallace R, et al: How proxies make decisions about research for patients with Alzheimer's disease. J Am Geriatr Soc 2001; 49:1110-1119
11. Karlawish JH, Casarett DJ, Klocinsky J, et al: How do AD patients and their caregivers decide whether to enroll in a clinical trial? Neurology 2001; 56:789-792
12. Black BS, Wechsler M, Fogarty L: Decision making for participation in dementia research. Am J Geriatr Psychiatry 2013; 21: 355-363
13. Gauthier S, Reisberg B, Zaudig M, et al: Mild cognitive impairment. Lancet 2006; 367:1262-1270
14. Jefferson AL, Lambe S, Moser DJ, et al: Decisional capacity for research participation in individuals with mild cognitive impairment. J Am Geriatr Soc 2008; 56:1236-1243
15. Okonkwo O, Griffith HR, Belue K, et al: Medical decision-making capacity in patients with mild cognitive impairment. Neurology 2007; 69:1528-1535
16. 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
17. Fassassi S, Bianchi Y, Stiefel F, et al: Assessment of the capacity to consent to treatment in patients admitted to acute medical wards. BMC Med Ethics 2009; 10:15
18. Whelan PJ, Oleszek J, Macdonald A, Gaughran F: The utility of the Mini-Mental State Examination in guiding assessment of capacity to consent to research. Int Psychogeriatr 2009; 21:338-344
19. Warner J, McCarney R, Griffin M, et al: Participation in dementia research: Rates and correlates of capacity to give informed consent. J Med Ethics 2008; 34:167-170
20. Etchells E, Darzins P, Silberfeld M, et al: Assessment of patient capacity to consent to treatment. J Gen Intern Med 1999; 14:27-34
21. www.trialregister.nl. Netherlands Trial Number 2829. Available at: Http://www.trialregister.nl/trialreg/admin/rctview. asp?TC=2829. Accessed July 18, 2013
22. Charmaz K: Grounded theory. Objectivist and constructivist methods, in Handbook of Qualitative Research. Edited by Denzin NK, Lincoln YS. London/New Delhi/Thousand Oaks, Sage, 2000, pp 509-535
23. Lucassen PLBJ, Olde Hartman TC: Kwalitatief onderzoek. Praktische methoden voor De medische praktijk. Houten, Bohn Stafleu Van Loghum, 2007
24. 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
25. Stanley B, Stanley M, Guido J, et al: The functional competency of elderly at risk. Gerontologist 1988; 28(suppl):53-58
26. Vellinga A, Smit JH, Van Leeuwen E, et al: Decision-making capacity of elderly patients assessed through the vignette method: Imagination or reality? Aging Ment Health 2005; 9: 40-48
27. Sabat SR: The Experience of Alzheimer's Disease: Life Through a Tangled Veil. Oxford, Blackwell, 2001