Development and Usability of ADappt: Web-Based Tool to Support Clinicians, Patients, and Caregivers in the Diagnosis of Mild Cognitive Impairment and Alzheimer Disease

Abstract

Background As a result of advances in diagnostic testing in the field of Alzheimer disease (AD), patients are diagnosed in earlier stages of the disease, for example, in the stage of mild cognitive impairment (MCI). This poses novel challenges for a clinician during the diagnostic workup with regard to diagnostic testing itself, namely, which tests are to be performed, but also on how to engage patients in this decision and how to communicate test results. As a result, tools to support decision making and improve risk communication could be valuable for clinicians and patients. Objective The aim of this study was to present the design, development, and testing of a Web-based tool for clinicians in a memory clinic setting and to ascertain whether this tool can (1) facilitate the interpretation of biomarker results in individual patients with MCI regarding their risk of progression to dementia, (2) support clinicians in communicating biomarker test results and risks to MCI patients and their caregivers, and (3) support clinicians in a process of shared decision making regarding the diagnostic workup of AD. Methods A multiphase mixed-methods approach was used. Phase 1 consisted of a qualitative needs assessment among professionals, patients, and caregivers; phase 2, consisted of an iterative process of development and the design of the tool (ADappt); and phase 3 consisted of a quantitative and qualitative assessment of usability and acceptability of ADappt. Across these phases, co-creation was realized via a user-centered qualitative approach with clinicians, patients, and caregivers. Results In phase 1, clinicians indicated the need for risk calculation tools and visual aids to communicate test results to patients. Patients and caregivers expressed their needs for more specific information on their risk for developing AD and related consequences. In phase 2, we developed the content and graphical design of ADappt encompassing 3 modules: a risk calculation tool, a risk communication tool including a summary sheet for patients and caregivers, and a conversation starter to support shared decision making regarding the diagnostic workup. In phase 3, ADappt was considered to be clear and user-friendly. Conclusions Clinicians in a memory clinic setting can use ADappt, a Web-based tool, developed using multiphase design and co-creation, for support that includes an individually tailored interpretation of biomarker test results, communication of test results and risks to patients and their caregivers, and shared decision making on diagnostic testing.

2020 update on the clinical validity of cerebrospinal fluid amyloid, tau, and phospho-tau as biomarkers for Alzheimer’s disease in the context of a structured 5-phase development framework

“…By comparison to PET, CSF tau measures can be described primarily as markers of disease state, with Tau PET serving as a marker of disease stage. This position is supported by a recent study that used stable isotope labeling kinetics to monitor the half-life and turnover rate of tau in the human CNS [203] and by recent in vivo findings [123,126]. Findings supportive of this model (i.e., that CSF and PET capture different aspects of AD pathology) have also been reported for Aβ-biomarkers [111,112].…”

“…Lastly, based on studies addressing the third secondary aim, which aims to developed algorithms to combine CSF AD biomarkers with other measures, multicentric data supports the combined use of CSF AD biomarkers to predict progression from MCI to AD dementia at the individual patient level [ 150 ]. Though the findings of this study have yet to be prospectively evaluated, it is conceivable that the models developed as part of this study could be used in clinical practice [ 204 ].…”

Clinicians’ communication with patients receiving a MCI diagnosis: The ABIDE project

“…Moreover, interpretation of biomarker results to gain estimates of the individual risk to develop dementia is not straightforward. Prediction models and computer-assisted clinical decision support systems may aid the clinician in interpreting clinical data and biomarker values and providing evidence-based individually-tailored prognostic information [23,32,33]. Nonetheless, even with a precise risk estimation in hand, the communication of this risk and its (uncertain) implications for the patient's future remains challenging [34], particularly so in cognitively impaired individuals.…”

Plasma biomarkers of Alzheimer’s disease predict cognitive decline and could improve clinical trials in the cognitively unimpaired elderly

“…15,16 With lower cost and higher accessibility, blood-based AD biomarkers may circumvent the limitations inherent to CSF and imaging. While recent work on plasma biomarkers has primarily focused on individualized risk assessment in patients with mild cognitive impairment (MCI), [4][5][6] it has been noted that substantial irreversible neuronal loss is already seen by this stage, which may reduce the likelihood of disease-modifying therapies to prevent dementia onset. 7 This has led to an increasing focus on cognitively unimpaired (CU) older individuals at risk for progression to AD dementia on the basis of biomarker evidence of brain AD pathology.…”