Multimedia Aided Consent for Alzheimer’s Disease Research

References

• Anglin, G. J., Vaez, H., & Cunningham, K. L. (2004). Visual representations and learning: The role of static and animated graphics. In D. H. Jonassen (Ed.), Handbook of research on educational communications and technology (2nd ed.) (pp. 865-916). Mahwah, NJ: Lawrence Erlbaum Associates Publishers.
   Google Scholar
• Appelbaum, P. S. (2006). Decisional capacity of patients with schizophrenia to consent to research: Taking stock. Schizophrenia Bulletin, 32(1), 22–25. doi:10.1093/schbul/sbi063
   PubMed Web of Science ®Google Scholar
• Appelbaum, P. S. (2016a). Protecting the rights of persons with disabilities: An international convention and its problems. Psychiatric Services, 67(4), 366–368. doi:10.1176/appi.ps.201600050
   PubMed Web of Science ®Google Scholar
• Appelbaum, P. S. (2016b). There are all kinds of rights. Hastings Center Report, 46(2). inside back cover. doi:10.1002/hast.549
   PubMed Web of Science ®Google Scholar
• Appelbaum, P. S., & Grisso, T. (2001). MacCAT-CR: MacArthur competence assessment tool for clinical research. Sarasota, FL: Professional Resource Press.
   Google Scholar
• Baddeley, A. D. (2007). Working memory, thought, and action. New York, NY: Oxford University Press.
   Google Scholar
• Black, B. S., Rabins, P. V., Sugarman, J., & Karlawish, J. H. (2010). Seeking assent and respecting dissent in dementia research. American Journal of Geriatric Psychiatry, 18(1), 77–85. doi:10.1097/JGP.0b013e3181bd1de2
   PubMed Web of Science ®Google Scholar
• Blanck, P., & Martinis, J. G. (2015). The right to make choices. The National Resource Center for Supported Decision-making. Inclusion, 3(1), 24–33. doi:10.1352/2326-6988-3.1.24
   Google Scholar
• Bondi, M. W., Jak, A. J., Delano-Wood, L., Jacobson, M. W., Delis, D. C., & Salmon, D. P. (2008). Neuropsychological contributions to the early identification of Alzheimer’s disease. Neuropsychology Review, 18(1), 73–90. doi:10.1007/s11065-008-9054-1
   PubMed Web of Science ®Google Scholar
• Brazo, P., Ilongo, M., & Dollfus, S. (2013). Distinct episodic verbal memory profiles in schizophrenia. Behavioral Science, 3(2), 192–205. doi:10.3390/bs3020192
   PubMedGoogle Scholar
• Cummings, J. L., Morstorf, T., & Zhong, K. (2014). Alzheimer’s disease drug-development pipeline: Few candidates, frequent failures. Alzheimers Research and Therapy, 6(4), 37. doi:10.1186/alzrt269
   PubMed Web of Science ®Google Scholar
• Dunn, L. B. (2006). Capacity to consent to research in schizophrenia: The expanding evidence base. Behavioral Sciences & the Law, 24(4), 431–445. doi:10.1002/bsl.698
   PubMed Web of Science ®Google Scholar
• Dunn, L. B., & Alici, Y. (2013). Ethical waves of the silver tsunami: Consent, capacity, and surrogate decision-making. American Journal of Geriatric Psychiatry, 21(4), 309–313. doi:10.1016/j.jagp.2013.01.023
   PubMed Web of Science ®Google Scholar
• Dunn, L. B., Candilis, P. J., & Roberts, L. W. (2006). Emerging empirical evidence on the ethics of schizophrenia research. Schizophrenia Bulletin, 32(1), 47–68. doi:10.1093/schbul/sbj012
   PubMed Web of Science ®Google Scholar
• Dunn, L. B., Lindamer, L. A., Palmer, B. W., Golshan, S., Schneiderman, L. J., & Jeste, D. V. (2002). Improving understanding of research consent in middle-aged and elderly patients with psychotic disorders. American Journal of Geriatric Psychiatry, 10(2), 142–150. doi:10.1097/00019442-200203000-00005
   PubMed Web of Science ®Google Scholar
• Dunn, L. B., Palmer, B. W., & Karlawish, J. H. T. (2007). Frontal dysfunction and capacity to consent to treatment or research: Conceptual considerations and empirical evidence. In B. L. Miller, & J. L. Cummings (Eds.), The human frontal lobes (2nd ed.) (pp. 335–344). New York, NY: Guilford Press.
   Google Scholar
• Ferreira-Vieira, T. H., Guimaraes, I. M., Silva, F. R., & Ribeiro, F. M. (2016). Alzheimer’s disease: Targeting the cholinergic system. Current Neuropharmacology, 14(1), 101–115. doi:10.2174/1570159X13666150716165726
   PubMed Web of Science ®Google Scholar
• Flory, J., & Emanuel, E. (2004). Interventions to improve research participants’ understanding in informed consent for research: A systematic review. JAMA, 292(13), 1593–1601. doi:10.1001/jama.292.13.1593
   PubMed Web of Science ®Google Scholar
• Folstein, M. F., Folstein, S. E., & McHugh, P. R. (1975). “Mini-mental state”: A practical method for grading the cognitive state of patients for the clinician. Journal of Psychiatric Research, 12(3), 189–198. doi:10.1016/0022-3956(75)90026-6
   PubMed Web of Science ®Google Scholar
• Han, S. D., Boyle, P. A., James, B. D., Yu, L., & Bennett, D. A. (2015). Mild cognitive impairment is associated with poorer decision-making in community-based older persons. Journal of the American Geriatrics Society, 63(4), 676–683. doi:10.1111/jgs.2015.63.issue-4
   PubMed Web of Science ®Google Scholar
• Heaton, R. K., Paulsen, J. S., McAdams, L. A., Kuck, J., Zisook, S., Braff, D., Harris, J., & Jeste, D. V. (1994). Neuropsychological deficits in schizophrenics. Relationship to age, chronicity, and dementia. Archives of General Psychiatry, 51(6), 469–476. doi:10.1001/archpsyc.1994.03950060033003
   PubMed Web of Science ®Google Scholar
• Howe, E. (2012). Informed consent, participation in research, and the Alzheimer’s patient. Innovations in Clinical Neuroscience, 9(5–6), 47–51.
   PubMedGoogle Scholar
• Jefferson, A. L., Carmona, H., Gifford, K. A., Lambe, S., Byerly, L. K., Cantwell, N. G., … Karlawish, J. (2012). Clinical research risk assessment among individuals with mild cognitive impairment. American Journal of Geriatric Psychiatry, 20(10), 878–886. doi:10.1097/JGP.0b013e318252e5cb
   PubMed Web of Science ®Google Scholar
• Jefferson, A. L., Lambe, S., Moser, D. J., Byerly, L. K., Ozonoff, A., & Karlawish, J. H. (2008). Decisional capacity for research participation in individuals with mild cognitive impairment. Journal of the American Geriatrics Society, 56(7), 1236–1243. doi:10.1111/jgs.2008.56.issue-7
   PubMed Web of Science ®Google Scholar
• Jeste, D. V., Depp, C. A., & Palmer, B. W. (2006). Magnitude of impairment in decisional capacity in people with schizophrenia compared to normal subjects: An overview. Schizophrenia Bulletin, 32(1), 121–128. doi:10.1093/schbul/sbj001
   PubMed Web of Science ®Google Scholar
• Jeste, D. V., Palmer, B. W., Golshan, S., Eyler, L. T., Dunn, L. B., Meeks, T., … Appelbaum, P. S. (2009). Multimedia consent for research in people with schizophrenia and normal subjects: A randomized controlled trial. Schizophrenia Bulletin, 35(4), 719–729. doi:10.1093/schbul/sbm148
   PubMed Web of Science ®Google Scholar
• Jurica, P. L., Leitten, C. L., & Mattis, S. (1991). Dementia Rating Scale-2. Professional manual. Odessa, FL: Psychological Assessment Resources, Inc.
   Google Scholar
• Karlawish, J. H., Casarett, D. J., & James, B. D. (2002). Alzheimer’s disease patients’ and caregivers’ capacity, competency, and reasons to enroll in an early-phase Alzheimer’s disease clinical trial. Journal of the American Geriatrics Society, 50(12), 2019–2024. doi:10.1046/j.1532-5415.2002.50615.x
   PubMed Web of Science ®Google Scholar
• Karlawish, J. H., Kim, S. Y., Knopman, D., Van Dyck, C. H., James, B. D., & Marson, D. (2008). Interpreting the clinical significance of capacity scores for informed consent in Alzheimer disease clinical trials. American Journal of Geriatric Psychiatry, 16(7), 568–574. doi:10.1097/JGP.0b013e318172b406
   PubMed Web of Science ®Google Scholar
• Keeling, A. (2016). Supported decision making: The rights of people with dementia. Nursing Standard, 30(30), 38–44. doi:10.7748/ns.30.30.38.s45
   PubMedGoogle Scholar
• Kim, S. Y., & Appelbaum, P. S. (2006). The capacity to appoint a proxy and the possibility of concurrent proxy directives. Behavioral Sciences & the Law, 24(4), 469–478. doi:10.1002/bsl.702
   PubMed Web of Science ®Google Scholar
• Kim, S. Y., Appelbaum, P. S., Jeste, D. V., & Olin, J. T. (2004). Proxy and surrogate consent in geriatric neuropsychiatric research: Update and recommendations. American Journal of Psychiatry, 161(5), 797–806. doi:10.1176/appi.ajp.161.5.797
   PubMed Web of Science ®Google Scholar
• Kim, S. Y., Appelbaum, P. S., Kim, H. M., Wall, I. F., Bourgeois, J. A., Frankel, B., … Karlawish, J. H. (2011). Variability of judgments of capacity: Experience of capacity evaluators in a study of research consent capacity. Psychosomatics, 52(4), 346–353. doi:10.1016/j.psym.2011.01.012
   PubMed Web of Science ®Google Scholar
• Kim, S. Y., Appelbaum, P. S., Swan, J., Stroup, T. S., McEvoy, J. P., Goff, D. C., … Caine, E. D. (2007). Determining when impairment constitutes incapacity for informed consent in schizophrenia research. British Journal of Psychiatry, 191, 38–43. doi:10.1192/bjp.bp.106.033324
   PubMed Web of Science ®Google Scholar
• Kim, S. Y., & Caine, E. D. (2002). Utility and limits of the mini mental state examination in evaluating consent capacity in Alzheimer’s disease. Psychiatric Services, 53(10), 1322–1324. doi:10.1176/appi.ps.53.10.1322
   PubMed Web of Science ®Google Scholar
• Kim, S. Y., Caine, E. D., Currier, G. W., Leibovici, A., & Ryan, J. M. (2001). Assessing the competence of persons with Alzheimer’s disease in providing informed consent for participation in research. American Journal of Psychiatry, 158(5), 712–717. doi:10.1176/appi.ajp.158.5.712
   PubMed Web of Science ®Google Scholar
• Kim, S. Y., Karlawish, J. H., Kim, H. M., Wall, I. F., Bozoki, A. C., & Appelbaum, P. S. (2011). Preservation of the capacity to appoint a proxy decision maker: Implications for dementia research. Archives of General Psychiatry, 68(2), 214–220. doi:10.1001/archgenpsychiatry.2010.191
   PubMed Web of Science ®Google Scholar
• Larkin, J. H., & Simon, H. A. (1987). Why a diagram is (sometimes) worth ten thousand words. Cognitive Science, 11(1), 65–100. doi:10.1111/j.1551-6708.1987.tb00863.x
   Web of Science ®Google Scholar
• Lemere, C. A. (2013). Immunotherapy for Alzheimer’s disease: Hoops and hurdles. Molecular Neurodegeneration, 8(1), 36. doi:10.1186/1750-1326-8-36
   PubMed Web of Science ®Google Scholar
• Mansoor, Y., Jastrzab, L., Dutt, S., Miller, B. L., Seeley, W. W., & Kramer, J. H. (2015). Memory profiles in pathology or biomarker confirmed Alzheimer disease and frontotemporal dementia. Alzheimer Disease and Associated Disorders, 29(2), 135–140.
   PubMed Web of Science ®Google Scholar
• Marson, D. C., & Harrell, L. (1999). Neurocognitive changes associated with loss of capacity to consent to medical treatment in patients with Alzheimer’s Disease. In D. C. Park, R. W. Morrell, & K. Shifren (Eds.), Processing of medical information in aging patients. Mahwah, NJ; London, UK: Lawrence Erlbaum Associates.
   Google Scholar
• Mayer, R. E. (2001). Multimedia learning. New York, NY: Cambridge University Press.
   Google Scholar
• Mayer, R. E. (2008). Applying the science of learning: Evidence-based principles for the design of multimedia instruction. American Psychologist, 63(8), 760–769. doi:10.1037/0003-066X.63.8.760
   PubMed Web of Science ®Google Scholar
• Mittal, D., Palmer, B. W., Dunn, L. B., Landes, R., Ghormley, C., Beck, C., … Jeste, D. V. (2007). Comparison of two enhanced consent procedures for patients with mild Alzheimer disease or mild cognitive impairment. American Journal of Geriatric Psychiatry, 15(2), 163–167. doi:10.1097/JGP.0b013e31802dd379
   PubMed Web of Science ®Google Scholar
• Moser, D. J., Reese, R. L., Hey, C. T., Schultz, S. K., Arndt, S., Beglinger, L. J., … Andreasen, N. C. (2006). Using a brief intervention to improve decisional capacity in schizophrenia research. Schizophrenia Bulletin, 32(1), 116–120. doi:10.1093/schbul/sbi066
   PubMed Web of Science ®Google Scholar
• Moye, J., Azar, A. R., Karel, M. J., & Gurrera, R. J. (2004). Hopes and cautions for instrument-based evaluation of consent capacity: Results of a construct validity study of three instruments. Ethics, Law, and Aging Review, 10, 39–61.
   Google Scholar
• Moye, J., Karel, M. J., Azar, A. R., & Gurrera, R. J. (2004). Capacity to consent to treatment: Empirical comparison of three instruments in older adults with and without dementia. Gerontologist, 44(2), 166–175. doi:10.1093/geront/44.2.166
   PubMed Web of Science ®Google Scholar
• National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research Retrieved from http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
   Google Scholar
• Okonkwo, O., Griffith, H. R., Belue, K., Lanza, S., Zamrini, E. Y., Harrell, L. E., … Marson, D. C. (2007). Medical decision-making capacity in patients with mild cognitive impairment. Neurology, 69(15), 1528–1535. doi:10.1212/01.wnl.0000277639.90611.d9
   PubMed Web of Science ®Google Scholar
• Palmer, B. W., Cassidy, E. L., Dunn, L. B., Spira, A. P., & Sheikh, J. I. (2008). Effective use of consent forms and interactive questions in the consent process. IRB: Ethics & Human Research, 30(2), 8–12.
   PubMedGoogle Scholar
• Palmer, B. W., Dawes, S. E., & Heaton, R. K. (2009). What do we know about neuropsychological aspects of schizophrenia? Neuropsychology Review, 19(3), 365–384. doi:10.1007/s11065-009-9109-y
   PubMed Web of Science ®Google Scholar
• Palmer, B. W., Dunn, L. B., Appelbaum, P. S., Mudaliar, S., Thal, L., Henry, R., … Jeste, D. V. (2005). 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. Archives of General Psychiatry, 62(7), 726–733. doi:10.1001/archpsyc.62.7.726
   PubMed Web of Science ®Google Scholar
• Palmer, B. W., & Harmell, A. L. (2016). Assessment of healthcare decision-making capacity. Archives of Clinical Neuropsychology, 31(6), 530–540. doi:10.1093/arclin/acw051
   PubMed Web of Science ®Google Scholar
• Palmer, B. W., Harmell, A. L., Pinto, L. L., Dunn, L. B., Kim, S. Y. H., Golshan, S., & Jeste, D. V. (2017). Determinants of capacity to consent to research on Alzheimer’s disease. Clinical Gerontologist, 40, 24–34. doi:10.1080/07317115.2016.1197352
   PubMed Web of Science ®Google Scholar
• Palmer, B. W., Heaton, R. K., Paulsen, J. S., Kuck, J., Braff, D., Harris, M. J., … Jeste, D. V. (1997). Is it possible to be schizophrenic yet neuropsychologically normal? Neuropsychology, 11(3), 437–446. doi:10.1037/0894-4105.11.3.437
   PubMed Web of Science ®Google Scholar
• Palmer, B. W., Lanouette, N. M., & Jeste, D. V. (2012). Effectiveness of multimedia aids to enhance comprehension during research consent: A systematic review. IRB: Ethics & Human Research, 34(6), 1–15.
   PubMedGoogle Scholar
• Palmer, B. W., Ryan, K. A., Kim, H. M., Karlawish, J. H., Appelbaum, P. S., & Kim, S. Y. (2013). Neuropsychological correlates of capacity determinations in Alzheimer disease: Implications for assessment. American Journal of Geriatric Psychiatry, 21(4), 373–381. doi:10.1016/j.jagp.2012.11.008
   PubMed Web of Science ®Google Scholar
• Palmer, B. W., & Savla, G. N. (2007). The association of specific neuropsychological deficits with capacity to consent to research or treatment. Journal of the International Neuropsychological Society, 13, 1047–1059. doi:10.1017/S1355617707071299
   PubMed Web of Science ®Google Scholar
• Paulsen, J. S., Heaton, R. K., Sadek, J. R., Perry, W., Delis, D. C., Braff, D., … Jeste, D. V. (1995). The nature of learning and memory impairments in schizophrenia. Journal of the International Neuropsychological Society, 1(1), 88–99. doi:10.1017/S135561770000014X
   PubMedGoogle Scholar
• Peisah, C., Sorinmade, O. A., Mitchell, L., & Hertogh, C. M. (2013). Decisional capacity: Toward an inclusionary approach. International Psychogeriatrics, 25(10), 1571–1579. doi:10.1017/S1041610213001014
   PubMed Web of Science ®Google Scholar
• Rubright, J., Sankar, P., Casarett, D. J., Gur, R., Xie, S. X., & Karlawish, J. (2010). A memory and organizational aid improves Alzheimer disease research consent capacity: Results of a randomized, controlled trial. American Journal of Geriatric Psychiatry, 18(12), 1124–1132. doi:10.1097/JGP.0b013e3181dd1c3b
   PubMed Web of Science ®Google Scholar
• Ryan, R. E., Prictor, M. J., McLaughlin, K. J., & Hill, S. J. (2008). Audio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database of Systematic Reviews, 1.
   Web of Science ®Google Scholar
• Saks, E. R., Dunn, L. B., & Palmer, B. W. (2006). Meta-consent in research on decisional capacity: A “Catch-22”? Schizophrenia Bulletin, 32(1), 42–46. doi:10.1093/schbul/sbj017
   PubMed Web of Science ®Google Scholar
• Salmon, D. P., & Bondi, M. W. (1999). Neuropsychology of Alzheimer disease. In D. P. Salmon, & M. W. Bondi (Eds.), Alzheimer Disease (2nd ed.), (pp. 39–56). Philadelphia, PA: Lippincott Williams & Wilkins.
   Google Scholar
• Sheehan, D. V., Lecrubier, Y., & Sheehan, K. H. (1998). The Mini-International Neuropsychiatric Interview (M.I.N.I.): The development of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. Journal of Clinical Psychiatry, 59, 22–33.
   PubMed Web of Science ®Google Scholar
• Shepherd, V. (2016). Research involving adults lacking capacity to consent: The impact of research regulation on ‘evidence biased’ medicine. BMC Medical Ethics, 17(1), 55. doi:10.1186/s12910-016-0138-9
   PubMed Web of Science ®Google Scholar
• Sugino, H., Watanabe, A., Amada, N., Yamamoto, M., Ohgi, Y., Kostic, D., & Sanchez, R. (2015). Global trends in alzheimer disease clinical development: Increasing the probability of success. Clinical Therapuetics, 37(8), 1632–1642. doi:10.1016/j.clinthera.2015.07.006
   PubMed Web of Science ®Google Scholar
• Synnot, A., Ryan, R., Prictor, M., Fetherstonhaugh, D., & Parker, B. (2014). Audio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database of Systematic Reviews, 5. doi:10.1002/14651858.CD003717.pub3
   PubMedGoogle Scholar
• Tröster, A. I., Butters, N., Salmon, D. P., Cullum, C. M., Jacobs, D., Brandt, J., & White, R. F. (1993). The diagnostic utility of savings scores: Differentiating Alzheimer’s and Huntington’s diseases with the logical memory and visual reproduction tests. Journal of Clinical and Experimental Neuropsychology, 15(5), 773–788. doi:10.1080/01688639308402595
   PubMed Web of Science ®Google Scholar
• Wallace, D. S., West, S. C., Ware, A., & Dansereau, D. F. (1998). The effect of knowledge maps that incorporate Gestalt principles on learning. Journal of Experimental Education, 67(1), 5–16. doi:10.1080/00220979809598341
   Web of Science ®Google Scholar
• Warner, J., McCarney, R., Griffin, M., Hill, K., & Fisher, P. (2008). Participation in dementia research: Rates and correlates of capacity to give informed consent. Journal of Medical Ethics, 34(3), 167–170. doi:10.1136/jme.2006.019786
   PubMed Web of Science ®Google Scholar
• Weintraub, S., Wicklund, A. H., & Salmon, D. P. (2012). The neuropsychological profile of Alzheimer disease. Cold Spring Harbor Perspectives in Medicine, 2(4), a006171. doi:10.1101/cshperspect.a006171
   PubMed Web of Science ®Google Scholar
• Wirshing, D. A., Sergi, M. J., & Mintz, J. (2005). A videotape intervention to enhance the informed consent process for medical and psychiatric treatment research. American Journal of Psychiatry, 162(1), 186–188. doi:10.1176/appi.ajp.162.1.186
   PubMed Web of Science ®Google Scholar