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Participant outcomes and preferences in Alzheimer’s disease clinical trials: The electronic Person Specific Outcome Measure (ePSOM) development programme

Research output: Contribution to journalArticle

Original languageEnglish
Pages (from-to)694-702
JournalAlzheimer's and Dementia: Translational Research and Clinical Interventions
Volume4
Early online date12 Dec 2018
DOIs
Publication statusE-pub ahead of print - 12 Dec 2018

Abstract

INTRODUCTION: Current pharmacological interventions for Alzheimer’s dementia delay symptom progression for about a year. While the outcomes in earlier disease states may include changes in biomarkers, the clinical effectiveness of any intervention can ultimately only be assessed by a patient’s self-reported wellbeing. A better understanding of earlier manifestations of Alzheimer’s disease and the drive for relevant outcome measures, allied to technological advances in artificial intelligence have mediated the ePSOM development programme.


METHOD: There are 4 sequential stages in the ePSOM development programme [1] literature review, [2] focus group study, [3] national survey and [4] development of an app for capturing person specific outcomes. Here, we report the overall approach to the programme incorporating our literature review on patient reported outcome measures and patient preferences in the Alzheimer’s disease population.


RESULTS: Alzheimer’s disease trials do not use any patient reported outcome measures (PROMs). Quality of Life measures are often used as proxies for this but they do not capture individual needs. Therefore, trials currently fail to reflect the participant’s aspirations for effect but rather default to clinico-statistical measure of cognition and function. There is no implementation of patient preferences despite evidence that understanding preferences may influence adherence to treatment.


DISCUSSION: It is important to consider preferences for an intervention and use PROMs for the measure of effectiveness given that both risk and benefit are judged by the recipient of the treatment. The ePSOM development programme will deliver the methodology for incorporating meaningful outcomes in clinical trials to expand upon current biological and clinical measurements of effectiveness.

    Research areas

  • patient preferences, patient reported outcome measures, Alzheimer’s disease clinical trials, dementia, clinical effectiveness

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