Real‐world evidence in Alzheimer's disease: The ROADMAP Data Cube

Janssen, Olin; Vos, Stephanie J.B.; García-Negredo, Glòria; Tochel, Claire; Gustavsson, Anders; Smith, Michael Sharwood; Ly, Amanda; Nelson, Mia; Baldwin, Helen; Sudlow, Catherine; Bexelius, Christin; Jindra, Christoph; Vaci, Nemanja; Bauermeister, Sarah; Gallacher, John; Ponjoan, Anna; Dufouil, Carole; Garré-Olmo, Josep; Pedersen, Lars Jacob Tynes; Skoog, Ingmar; Hottgenroth, Antje; Visser, Pieter Jelle; Lei, Johan van der; Díaz, Carlos

doi:10.1016/j.jalz.2019.09.087

Cited by 15 publications

(15 citation statements)

References 9 publications

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“…Operationalizing these outcomes is not a trivial task. Previous projects aiming to this target, i.e., the “Dementia Outcomes Measurement Suite” (DOMS) [ 52 ] and the “Real world Outcomes across the Alzheimer’s Disease spectrum for better care: Multi-modal data Access Platform” (ROADMAP) [ 53 ], also found gaps in these key areas of Alzheimer’s disease and related disorders. In particular, they showed a lack in the operationalization of outcomes related to the final stage of the disease, entailing relevant long-term outcomes [ 54 , 55 ].…”

Section: Discussionmentioning

confidence: 99%

Outcomes of clinical utility in amyloid-PET studies: state of art and future perspectives

Ramusino

Perini

Altomare

et al. 2021

Eur J Nucl Med Mol Imaging

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Purpose To review how outcomes of clinical utility are operationalized in current amyloid-PET validation studies, to prepare for formal assessment of clinical utility of amyloid-PET-based diagnosis. Methods Systematic review of amyloid-PET research studies published up to April 2020 that included outcomes of clinical utility. We extracted and analyzed (a) outcome categories, (b) their definition, and (c) their methods of assessment. Results Thirty-two studies were eligible. (a) Outcome categories were clinician-centered (found in 25/32 studies, 78%), patient-/caregiver-centered (in 9/32 studies, 28%), and health economics-centered (5/32, 16%). (b) Definition: Outcomes were mainly defined by clinical researchers; only the ABIDE study expressly included stakeholders in group discussions. Clinician-centered outcomes mainly consisted of incremental diagnostic value (25/32, 78%) and change in patient management (17/32, 53%); patient-/caregiver-centered outcomes considered distress after amyloid-pet-based diagnosis disclosure (8/32, 25%), including quantified burden of procedure for patients’ outcomes (n = 8) (1/8, 12.5%), impact of disclosure of results (6/8, 75%), and psychological implications of biomarker-based diagnosis (75%); and health economics outcomes focused on costs to achieve a high-confidence etiological diagnosis (5/32, 16%) and impact on quality of life (1/32, 3%). (c) Assessment: all outcome categories were operationalized inconsistently across studies, employing 26 different tools without formal rationale for selection. Conclusion Current studies validating amyloid-PET already assessed outcomes for clinical utility, although non-clinician-based outcomes were inconsistent. A wider participation of stakeholders may help produce a more thorough and systematic definition and assessment of outcomes of clinical utility and help collect evidence informing decisions on reimbursement of amyloid-PET.

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Section: Discussionmentioning

confidence: 99%

Outcomes of clinical utility in amyloid-PET studies: state of art and future perspectives

Ramusino

Perini

Altomare

et al. 2021

Eur J Nucl Med Mol Imaging

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“…A total of 38 outcomes were identified, and these were organized into eight overarching domains, namely cognitive abilities, functional abilities, behavioural and neuropsychiatric symptoms, quality of life of the person with dementia, impact on carers, medical investigations, mortality and comorbidities, and significant disease‐related life events. These outcomes have been integrated into key ROADMAP outputs 11,33 …”

Section: Impact Of Public Involvement On the Roadmap Studymentioning

confidence: 99%

“…The EWGPWD's feedback on the conceptualization of stages was fed into the survey design 33 and ROADMAP's Data Cube 11 as it was considered useful and meaningful to people with dementia and their caregivers.…”

Section: Impact Of Public Involvement On the Roadmap Studymentioning

confidence: 99%

“…from pre‐clinical Alzheimer's disease to Alzheimer's dementia). Findings would inform the development of a data platform that integrates multiple sources of real‐world data related to Alzheimer's disease, called the Data Cube, 11 to enhance researchers' understanding of disease progression in the real world. To achieve this goal, ROADMAP involved people with dementia and caregivers in the research process, not only as participants but also as advisors.…”

Section: Introductionmentioning

confidence: 99%

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Conducting public involvement in dementia research: The contribution of the European Working Group of People with Dementia to the ROADMAP project

Diaz

Gove

Nelson

et al. 2021

Health Expectations

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Background Dementia outcomes include memory loss, language impairment, reduced quality of life and personality changes. Research suggests that outcomes selected for dementia clinical trials might not be the most important to people affected. Objective One of the goals of the ‘Real world Outcomes across the Alzheimer's Disease spectrum for better care: Multi‐modal data Access Platform’ (ROADMAP) project was to identify important outcomes from the perspective of people with dementia and their caregivers. We review how ROADMAP's Public Involvement shaped the programme, impacted the research process and gave voice to people affected by dementia. Design The European Working Group of People with Dementia (EWGPWD) were invited to participate. In‐person consultations were held with people with dementia and caregivers, with advance information provided on ROADMAP activities. Constructive criticism of survey content, layout and accessibility was sought, as were views and perspectives on terminology and key concepts around disease progression. Results The working group provided significant improvements to survey accessibility and acceptability. They promoted better understanding of concepts around disease progression and how researchers might approach measuring and interpreting findings. They effectively expressed difficult concepts through real‐world examples. Conclusions The role of the EWGPWD in ROADMAP was crucial, and its impact was highly influential. Involvement from the design stage helped shape the ethos of the programme and ultimately its meaningfulness. Public contribution People with dementia and their carers were involved through structured consultations and invited to provide feedback on project materials, methods and insight into terminology and relevant concepts.

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“…A new form of health care should also be sustainable. Next to reducing healthcare costs, sustainability is defined by an improved experience of care and improved health of the population 89 . By adhering to the criteria of cost-effectivity and sustainability, primary care-based nurse-led aftercare could contribute to managing the (increasing) economic impact of stroke and TBI on society.…”

Section: Predictors Of Long-term Psychosocial Outcome After Strokementioning

confidence: 99%

Psychosocial outcome after stroke and traumatic brain injury

Verberne¹

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Real‐world evidence in Alzheimer's disease: The ROADMAP Data Cube

Cited by 15 publications

References 9 publications

Outcomes of clinical utility in amyloid-PET studies: state of art and future perspectives

Outcomes of clinical utility in amyloid-PET studies: state of art and future perspectives

Conducting public involvement in dementia research: The contribution of the European Working Group of People with Dementia to the ROADMAP project

Psychosocial outcome after stroke and traumatic brain injury

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