Advertisement

The journal of nutrition, health & aging

, Volume 17, Issue 4, pp 385–389 | Cite as

Capacity to consent to biomedical research’s evaluation among older cognitively impaired patients. A study to validate the University of California Brief Assessment of Capacity to Consent questionnaire in French among older cognitively impaired patients

  • Emmanuelle DuronEmail author
  • M. Boulay
  • Jean-Sébastien Vidal
  • Jamila El Bchiri
  • Marie-Laure Fraisse
  • Anne Sophie Rigaud
  • Laurence Hugonot-DienerEmail author
Article

Abstract

Context

Some studies have highlighted the difficulty for physicians to evaluate patient’s ability to consent to bio-medical research in the elderly population. The University of California Brief Assessment of Capacity to Consent (UBACC) is a rapid questionnaire to assess the ability to consent, previously validated among schizophrenic patients.

Objective

To evaluate the accuracy of the UBACC scale, French version, to determine the capacity to consent to biomedical studies of older people with normal cognition, mild cognitive impairment (MCI) or Alzheimer Disease (AD).

Design

A prospective validation study between September 2008 to November 2011.

Setting

A Memory clinic.

Patients

We included 61 subjects in a memory clinic who had already consented to participate to a biomedical research and had signed a consent form. Those subjects, who had memory impairment, had a comprehensive neuro-psychological (including Mini Mental State Examination (MMSE)/30), clinical, biological assessment and brain imagery during day-care hospital. They were classified as MCI or AD patients. Control group included patients’ caregivers without memory complaints and a normal comprehensive neuro-psychological assessment.

Intervention and measurements

The consent form was once again explained to the subjects by a physician who subjectively evaluated if subjects had understood the study. Then, the 10 questions of the French version of the UBACC scale (max score 20) were asked to the participants. This scale evaluates the understanding of the study’s aim, risks and benefits. A comparison was made between subjective assessment and the UBACC score.

Results

The physician considered that 18/61 patients (2 MCI and 16 AD) had not understood. These ones had a lower UBACC score (Score/20 (SD) [range]: 7.56 (3.03) [0–12] versus 17.72 (2.68) [13–28], p<0.001), a lower MMSE (Score/30 (SD): 21.1 (5.9) versus 27.3 (2.9); p<0.001) and were older (age (years old) 80.8 versus 76.6. p<0.0001) compared to those who had understood. Moreover, all the patients who had not understood had an UBACC score ≤ 12. The administration time was accurate in this population (<10 minutes).

Conclusion

The UBACC scale, in its French version, was accurate to assess capacity to consent in an older, cognitively impaired population.

Keywords

Mild Cognitive Impairment Mini Mental State Examination Mini Mental State Examination Score Decisional Capacity French Version 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Ferri CP, Prince M, Brayne C et al. Global prevalence of dementia: a Delphi consensus study. Lancet. 2005;366:2112–2117.PubMedCrossRefGoogle Scholar
  2. 2.
    Lobo A, Launer LJ, Fratiglioni L et al. Prevalence of dementia and major subtypes in Europe: A collaborative study of population-based cohorts. Neurologic Diseases in the Elderly Research Group. Neurology. 2000;54:84–89.Google Scholar
  3. 3.
    Dunn LB, Jeste DV. Enhancing informed consent for research and treatment. Neuropsychopharmacology. 2001:24:595–607.PubMedCrossRefGoogle Scholar
  4. 4.
    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.PubMedCrossRefGoogle Scholar
  5. 5.
    American Psychiatric Association. Guidelines for assessing the decision-making capacities of potential research subjects with cognitive impairment. American J Psychiatry’. 1998;155:1649–1650.Google Scholar
  6. 6.
    Hugonot-Diener L, Husson JM. Communicating with the elderly: decision making and informed consent in subjects with frailty or dementia. Research Ethics Review. 2007;3:97–101.CrossRefGoogle Scholar
  7. 7.
    Teste DV, Palmer BW, Appelbaimi PS et al. A new brief instrument for assessing decisional capacity for clinical research. Arch Gen Psychiatry. 2007;64:966–974.CrossRefGoogle Scholar
  8. 8.
    Appelbaum PS, Grisso T. MacCAT-CR: MacArthur Competence Assessment Tool for Clinical Research. Sarasota, FL: Professional Resource Press. 2001;:.Google Scholar
  9. 9.
    Wilson HS, Skodol A. Special report: DSM-IV: overview and examination of major changes. Arch Psychiatr Nurs. 1994;8:340–347.PubMedCrossRefGoogle Scholar
  10. 10.
    McKhann G, Drachman D, Folstein M et al. Clinical diagnosis of Alzheimer’s disease: report of the N1NCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer’s Disease. Neurology. 1984;34:939–944.PubMedCrossRefGoogle Scholar
  11. 11.
    Portet F, Ousset PJ, Visser PJ et al. Mild cognitive impairment (MCI) in medical practice: a critical review of the concept and new diagnostic procedure. Report of the MCI Working Group of the European Consortium on Alzheimer’s Disease. J Neurol Neurosurg Psychiatry. 2006;77:714–718.PubMedCrossRefGoogle Scholar
  12. 12.
    Kalafat M, Hugonot-Diener L, Poitrenaud J. Etalonnage français du MMS version GRECO. Revue de neuropsychologie. 2003;13:209–236.Google Scholar
  13. 13.
    Folstein MF, Folstein SE, McHugh PR. “Mini-mental state”. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975;12:189–198.PubMedCrossRefGoogle Scholar
  14. 14.
    Buschke H, Kuslansky G, Katz M et al. Screening for dementia with the memory impairment screen. Neurology. 1999:52:231–238.PubMedCrossRefGoogle Scholar
  15. 15.
    De Rotrou J, Forette F, Hervy M et al. The cognitive efficiency profile: Description and validation in patients with Alzheimer’s disease. Int J Geriatr Psychiatry. 1991;6:501–509.CrossRefGoogle Scholar
  16. 16.
    Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969;9:179–186.PubMedCrossRefGoogle Scholar
  17. 17.
    Katz S, Ford AB, Moskowitz RW et al. Studies of illmess in the aged. The index of ADL: a standardized measure of biological and psychosocial function. JAMA. 1963;185:914–919.Google Scholar
  18. 18.
    Yesavage LA, Brink TL, Rose TL et al. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982–1983;17:37–49.PubMedCrossRefGoogle Scholar
  19. 19.
    Dunn LB, Nowrangi MA, Palmer BW et al. Assessing decisional capacity for clinical research or treatment: a review of instruments. Am J Psychiatry. 2006;163:1323–1334.PubMedCrossRefGoogle Scholar
  20. 20.
    Karlawish JHT, 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. J Am Geriatr Soc. 2002;50:2019–2024.PubMedCrossRefGoogle Scholar
  21. 21.
    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.PubMedCrossRefGoogle Scholar
  22. 22.
    Buckles VD, Powlishta KK, Palmer JL et al. Understanding of informed consent by demented individuals. Neurology. 2003;61:1662–1666.PubMedCrossRefGoogle Scholar
  23. 23.
    Grigoletto F, Zappala G, Anderson DW et al. Norms for the Mini-Mental State Examination in a healthy population. Neurology. 1999;53:315–320.PubMedCrossRefGoogle Scholar
  24. 24.
    Karlawish JHT, Casarett DJ, James BD et al. The ability of persons with Alzheimer disease (AD) to make a decision about taking an AD treatment. Neurology. 2005;64:1514–1519.PubMedCrossRefGoogle Scholar
  25. 25.
    Sachs GA. Advance consent for dementia research. Alzheimer Dis Assoc Disord. 1994;8:19–27.PubMedGoogle Scholar
  26. 26.
    Kim SY, Came 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.PubMedCrossRefGoogle Scholar
  27. 27.
    Karlawish JH, Casarett D, Klocinski J et al. How do AD patients and their caregivers decide whether to enroll in a clinical trial?. Neurology. 2001;56:789–792.PubMedCrossRefGoogle Scholar

Copyright information

© Serdi and Springer-Verlag France 2013

Authors and Affiliations

  • Emmanuelle Duron
    • 1
    • 2
    Email author
  • M. Boulay
    • 1
    • 2
  • Jean-Sébastien Vidal
    • 1
    • 2
  • Jamila El Bchiri
  • Marie-Laure Fraisse
    • 3
  • Anne Sophie Rigaud
    • 1
    • 2
  • Laurence Hugonot-Diener
    • 1
    • 2
    Email author
  1. 1.groupe hospitalier Paris-centre. Broca Hospital, Department of GeriatricsAP-HPParisFrance
  2. 2.Sorbonne Paris Cité, EA 4468Université Paris DescartesParisFrance
  3. 3.Merck Serono-GenevaGenevaSwitzerland

Personalised recommendations