Options for Evaluating Treatment Benefit in MCI and Prodromal Alzheimer’s Disease: Content Validity of the Perceived Deficits Questionnaire (PDQ) in Patients with Early Symptoms of Cognitive Decline

Abstract

Background: Many instruments used to assess outcomes of treatment for Alzheimer’s disease (AD) have no published evidence of their relevance and content validity in earlier stages of the disease, i.e., mild cognitive impairment, or prodromal AD (pAD). The objective of this project was to evaluate the applicability and usefulness of the Perceived Deficits Questionnaire (PDQ) as an outcome measure in this population using qualitative methodology to support content validity. Method: Two waves of qualitative interviews were conducted in patients with MCI and pAD. Results: Evidence for content validity and usefulness of the instrument was demonstrated in the patient interviews. Minor modifications to the wording of several items were suggested for the PDQ and the recall period was changed. Conclusion: With these modifications, the PDQ has improved content validity and relevance. It is therefore a potentially useful outcome measure to evaluate therapeutic benefit in interventional studies of patients in the early stages of AD.

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Lenderking, W. , Steenrod, A. , Rüdell, K. , Klapper, S. , Howard, K. and Gaudig, M. (2014) Options for Evaluating Treatment Benefit in MCI and Prodromal Alzheimer’s Disease: Content Validity of the Perceived Deficits Questionnaire (PDQ) in Patients with Early Symptoms of Cognitive Decline. Advances in Alzheimer's Disease, 3, 1-10. doi: 10.4236/aad.2014.31001.

Conflicts of Interest

The authors declare no conflicts of interest.

References

[1] Frank, L., Lenderking, W.R., Howard, K. and Cantillon, M. (2011) Patient Self-Report for Evaluating Mild Cognitive Impairment and Prodromal Alzheimer’s Disease. Alzheimer’s Research & Therapy, 3, 35. http://dx.doi.org/10.1186/alzrt97
[2] Albert, M.S., DeKosky, S.T., Dickson, D., Dubois, B., Feldman, H.H., Fox, N.C., et al. (2011) 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. Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association. [Consensus Development Conference, NIH Research Support, Non-U.S. Gov’t]. 7, 270-279.
[3] Petersen, R.C., Smith, G.E., Waring, S.C., Ivnik, R.J., Tangalos, E.G. and Kokmen, E. (1999) Mild Cognitive Impairment: Clinical Characterization and Outcome. Archives of Neurology, [Research Support, U.S. Gov’t, P.H.S.]. 56, 303-308.
[4] Dubois, B., Picard, G. and Sarazin, M. (2009) Early Detection of Alzheimer’s Disease: New Diagnostic Criteria. Dialogues in Clinical Neuroscience, 11, 135-139.
[5] Ganguli, M., Snitz, B.E., Saxton, J.A., Chang, C.C., Lee, C.W., Vander, B.J., et al. (2011) Outcomes of Mild Cognitive Impairment by Definition: A Population Study. Archives of Neurology, [Research Support, N.I.H., Extramural]. 68, 761-767.
[6] Leidy, N.K. and Vernon, M. (2008) Perspectives on Patient-Reported Outcomes: Content Validity and Qualitative Research in a Changing Clinical Trial Environment. PharmacoEconomics, 26, 363-370. http://dx.doi.org/10.2165/00019053-200826050-00002
[7] Sullivan, J., Edgeley, K. and Dehoux, E. (1990) A Survey of Multiple Sclerosis. Part I: Perceived Cognitive Problems and Compensatory Strategy Used. Canadian Journal of Rehabilitation, 4, 99-105.
[8] Doody, R.S., Ferris, S.H., Salloway, S., Sun, Y., Goldman, R., Watkins, W.E., et al. (2009) Donepezil Treatment of Patients with MCI: A 48-Week Randomized, Placebo-Controlled Trial. Neurology. [Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov’t].72, 1555-1561.
[9] Food and Drug Administration (2009) Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Federal Register, 74, 65132-65133.
[10] Patrick, D.L., Burke, L.B., Gwaltney, C.J., Leidy, N.K., Martin, M.L., Molsen, E., et al. (2011) 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 in Health: The Journal of the International Society for Pharmacoeconomics and Outcomes Research, 14, 967-977.
[11] Mateer, C.A., Sohlberg, M.M. and Crinean, J. (1987) Focus on Clinical Research: Perceptions of Memory Function in Individuals with Closed-Head Injury. The Journal of Head Trauma Rehabilitation, 2, 74-84. http://dx.doi.org/10.1097/00001199-198709000-00009
[12] Muhr, T. (2004) User’s Manual for ATLAS.ti 5.0. Berlin: ATLAS.ti Scientific Software Development GmbH.

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