Development of a patient-reported outcome instrument to assess complex activities of daily living and interpersonal functioning in persons with mild cognitive impairment: The qualitative research phase

Alzheimer's and Dementia

Volumn 12, Issue 1, 2016, Pages 75-84

  Gordon, Mark Forrest ^a   Lenderking, William R ^b   Duhig, Amy ^c   Chandler, Julie ^d   Lundy, J Jason ^e   Miller, David S ^f   Piault Louis, Elisabeth ^g   Doody, Rachelle S ^h   Galasko, Douglas ⁱ   Gauthier, Serge ^j   Frank, Lori ^k  

^a BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^b UNITED BIOSOURCE CORPORATION   (United States)

^c XCENDA   (United States)

^d MERCK RESEARCH LABORATORIES   (United States)

^e Outcometrix   (United States)

^f Bracket   (United States)

^g GENENTECH INC   (United States)

^h BAYLOR COLLEGE OF MEDICINE   (United States)

ⁱ UNIVERSITY OF CALIFORNIA   (United States)

^j MCGILL UNIVERSITY   (Canada)

^k Outcomes Research Institute   (United States)

more..

Author keywords

Activities of daily living; Alzheimer's disease; Cognition; Critical Path Institute; Interpersonal functioning; Mild cognitive impairment; Patient reported outcome; Qualitative

Indexed keywords

AGED; ALZHEIMER DISEASE; COGNITIVE DEFECT; CONCEPTUAL FRAMEWORK; CONTROLLED STUDY; CONVERSATION; DAILY LIFE ACTIVITY; EDUCATIONAL STATUS; FEMALE; HUMAN; INFORMATION PROCESSING; INTERPERSONAL FUNCTIONING; INTERVIEW; MAJOR CLINICAL STUDY; MALE; MILD COGNITIVE IMPAIRMENT; ORAL COMMUNICATION; OUTCOME ASSESSMENT; PRIORITY JOURNAL; QUALITATIVE ANALYSIS; QUALITATIVE RESEARCH; REVIEW; SKILL; SOCIAL INTERACTION; THEMATIC ANALYSIS; WRITTEN COMMUNICATION; HUMAN RELATION; MIDDLE AGED; NEUROPSYCHOLOGICAL TEST; PSYCHOLOGY; SELF REPORT; STANDARDS; VERY ELDERLY;

ACTIVITIES OF DAILY LIVING; AGED; AGED, 80 AND OVER; ALZHEIMER DISEASE; FEMALE; HUMANS; INTERPERSONAL RELATIONS; MALE; MIDDLE AGED; MILD COGNITIVE IMPAIRMENT; NEUROPSYCHOLOGICAL TESTS; PATIENT OUTCOME ASSESSMENT; QUALITATIVE RESEARCH; SELF REPORT;

EID: 84954026638     PISSN: 15525260     EISSN: 15525279     Source Type: Journal    
DOI: 10.1016/j.jalz.2015.04.008     Document Type: Review

References (32)

1. B. Dubois, G. Picard, and M. Sarazin Early detection of Alzheimer's disease: New diagnostic criteria Dialogues Clin Neurosci 11 2009 135 139
2. M.S. Albert, S.T. DeKosky, D. Dickson, B. Dubois, H.H. Feldman, N.C. Fox, and et al. The diagnosis of mild cognitive impairment due to Alzheimer's disease: Recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease Alzheimers Dement 7 2011 270 279
3. Food and Drug Administration. Guidance for industry-Alzheimer's disease: Developing drugs for the treatment of early stage disease, draft guidance, Feb. 2013, Clinical/Medical. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM338287.pdf. Accessed April 27, 2014.
4. G.Y. Hsiung, S. Alipour, C. Jacova, J. Grand, S. Gauthier, S.E. Black, and et al. Transition from cognitively impaired not demented to Alzheimer's disease: An analysis of changes in functional abilities in a dementia clinic cohort Dement Geriatr Cogn Disord 25 2008 483 490
5. E. Teng, B.W. Becker, E. Woo, J.L. Cummings, and P.H. Lu Subtle deficits in instrumental activities of daily living in subtypes of mild cognitive impairment Dement Geriatr Cogn Disord 30 2010 189 197
6. R.S. Doody, S.H. Ferris, S. Salloway, Y. Sun, R. Goldman, W.E. Watkins, and et al. Donepezil treatment of patients with MCI: A 48-week randomized, placebo-controlled trial Neurology 72 2009 1555 1561
7. L. Frank, W.R. Lenderking, K. Howard, and M. Cantillon Patient self-report for evaluating mild cognitive impairment and prodromal Alzheimer's disease Alzheimers Res Ther 3 2011 35
8. S.T. Farias, D. Mungas, B.R. Reed, D. Cahn-Weiner, W. Jagust, K. Baynes, and et al. The measurement of everyday cognition (ECog): Scale development and psychometric properties Neuropsychology 22 2008 531 544
9. D. Galasko, D.A. Bennett, M. Sano, D. Marson, J. Kaye, and S.D. Edland ADCS Prevention Instrument Project: Assessment of instrumental activities of daily living for community-dwelling elderly individuals in dementia prevention clinical trials Alzheimer Dis Assoc Disord 20 2006 S152 S169
10. J.A. Schinka, L.M. Brown, and Z. Proctor-Weber Measuring change in everyday cognition: Development and initial validation of the cognitive change checklist (3CL) Am J Geriatr Psychiatry 17 2009 516 525
11. J.A. Schinka, A. Raj, D.A. Loewenstein, B.J. Small, R. Duara, and H. Potter The cognitive change checklist (3CL): Cross-validation of a measure of change in everyday cognition Int J Geriatr Psychiatry 25 2010 266 274
12. L. Frank, J.A. Flynn, L. Kleinman, M.K. Margolis, L.S. Matza, C. Beck, and et al. Validation of a new symptom impact questionnaire for mild to moderate cognitive impairment Int Psychogeriatr 18 2006 135 149
13. Food and Drug Administration. Guidance for industry: Patient-reported outcome measures: Use in medical product development to support labeling claims, Dec. 2009, Clinical/Medical. Available at: http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf. Accessed April 27, 2014.
14. Food and Drug Administration. Guidance for industry and FDA staff: Qualification process for drug development tools, January 2014, Procedural. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM230597.pdf. Accessed April 27, 2014.
15. S. Balsis, B.D. Carpenter, and M. Storandt Personality change precedes clinical diagnosis of dementia of the Alzheimer type J Gerontol B Psychol Sci Soc Sci 60 2005 P98 P101
16. B.G. Glaser, and A.L. Strauss The discovery of grounded theory 1967 Aldine Chicago
17. A.L. Strauss, and J. Corbin Basics of qualitative research: Techniques and procedures for developing grounding theory 3rd ed. 2007 SAGE Publications Thousand Oaks, CA
18. American Psychiatric Association Diagnostic and statistical manual of mental disorders 4th ed. 1994 American Psychiatric Press Washington, D.C.
19. G. McKhann, D. Drachman, M. Folstein, R. Katzman, D. Price, and E.M. Stadlan Clinical diagnosis of Alzheimer's disease: Report of the NINCDS-ADRDA Work Group under the auspices of the Department of Health and Human Services Task Force on Alzheimer's disease Neurology 34 1984 939 944
20. B. Winblad, K. Palmer, M. Kivipelto, V. Jelic, L. Fratiglioni, L.O. Wahlund, and et al. Mild cognitive impairment - Beyond controversies, towards a consensus: Report of the International Working Group on mild cognitive impairment J Intern Med 256 2004 240 246
21. S. Katz, A.B. Ford, R.W. Moskowitz, B.A. Jackson, and M.W. Jaffe Studies of illness in the aged. The index of ADL: A standardized measure of biological and psychosocial function JAMA 185 1963 914 919
22. M.P. Lawton, and E.M. Brody Assessment of older people: Self-maintaining and instrumental activities of daily living Gerontologist 9 1969 179 186
23. H.P. Bennett, O. Piguet, D.A. Grayson, H. Creasey, L.M. Waite, T. Lye, and et al. Cognitive, extrapyramidal, and magnetic resonance imaging predictors of functional impairment in nondemented older community dwellers: The Sydney Older Person Study J Am Geriatr Soc 54 2006 3 10
24. D.L. Patrick, L.B. Burke, C.J. Gwaltney, N.K. Leidy, M.L. Martin, E. Molsen, and et al. Content validity - Establishing and reporting the evidence in newly-developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: Part 1-eliciting concepts for a new PRO instrument Value Health 14 2011 967 977
25. D.L. Patrick, L.B. Burke, C.J. Gwaltney, N.K. Leidy, M.L. Martin, E. Molsen, and et al. Content validity - Establishing and reporting the evidence in newly-developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: Part 2-assessing respondent understanding Value Health 14 2011 978 988
26. F. Clement, S. Belleville, and S. Gauthier Cognitive complaint in mild cognitive impairment and Alzheimer's disease J Int Neuropsychol Soc 14 2008 222 232
27. Y. Kashiwa, Y. Kitabayashi, J. Narumoto, K. Nakamura, H. Ueda, and K. Fukui Anosognosia in Alzheimer's disease: Association with patient characteristics, psychiatric symptoms and cognitive deficits Psychiatry Clin Neurosci 59 2005 697 704
28. S.E. Starkstein, R. Jorge, R. Mizrahi, and R.G. Robinson A prospective longitudinal study of apathy in Alzheimer's disease J Neurol Neurosurg Psychiatry 77 2006 8 11
29. L.M. Reid, and A.M. Maclullich Subjective memory complaints and cognitive impairment in older people Dement Geriatr Cogn Disord 22 2006 471 485
30. R.C. Petersen, J.C. Stevens, M. Ganguli, E.G. Tangalos, J.L. Cummings, and S.T. DeKosky Practice parameter: early detection of dementia: mild cognitive impairment (an evidence-based review). Report of the Quality Standards Subcommittee of the American Academy of Neurology Neurology 56 2001 1133 1142
31. R.C. Petersen Conceptual overview R.C. Petersen, Mild cognitive impairment: Aging to Alzheimer's disease 2003 Oxford University Press New York 1 14
32. R.C. Petersen Mild cognitive impairment as a diagnostic entity J Intern Med 256 2004 183 194