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Generating real-world evidence in Alzheimer's disease: Considerations for establishing a core dataset

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dc.contributor.author Galvin, James E.
dc.contributor.author Cummings, Jeffrey L.
dc.contributor.author Levitchi Benea, Mihaela
dc.contributor.author de Moor, Carl
dc.contributor.author Allegri, Ricardo Francisco
dc.contributor.author Atri, Alireza
dc.contributor.author Chertkow, Howard
dc.contributor.author Paquet, Claire
dc.contributor.author Porter, Verna R.
dc.contributor.author Ritchie, Craig W.
dc.contributor.author Sikkes, Sikkes A.M.
dc.contributor.author Smith, Michael R.
dc.contributor.author Grassi, Christina Marsica
dc.contributor.author Rubino, Ivana
dc.date.accessioned 2024-07-23T14:26:40Z
dc.date.available 2024-07-23T14:26:40Z
dc.date.issued 2024-05-06
dc.identifier.citation Galvin JE, Cummings JL, Benea ML, de Moor C, Allegri RF, Atri A, Chertkow H, Paquet C, Porter VR, Ritchie CW, Sikkes SAM, Smith MR, Grassi CM, Rubino I. Generating real-world evidence in Alzheimer's disease: Considerations for establishing a core dataset. Alzheimers Dement. 2024 Jun;20(6):4331-4341. doi: 10.1002/alz.13785. Epub 2024 May 6. es_ES
dc.identifier.uri https://doi.org/10.1002/alz.13785
dc.identifier.uri https://repositorio.fleni.org.ar/xmlui/handle/123456789/1170
dc.description.abstract Ongoing assessment of patients with Alzheimer's disease (AD) in postapproval studies is important for mapping disease progression and evaluating real-world treatment effectiveness and safety. However, interpreting outcomes in the real world is challenging owing to variation in data collected across centers and specialties and greater heterogeneity of patients compared with trial participants. Here, we share considerations for observational postapproval studies designed to collect harmonized longitudinal data from individuals with mild cognitive impairment or mild dementia stage of disease who receive therapies targeting the underlying pathological processes of AD in routine practice. This paper considers key study design parameters, including proposed aims and objectives, study populations, approaches to data collection, and measures of cognition, functional abilities, neuropsychiatric status, quality of life, health economics, safety, and drug utilization. Postapproval studies that capture these considerations will be important to provide standardized data on AD treatment effectiveness and safety in real-world settings. es_ES
dc.language.iso eng es_ES
dc.publisher John Wiley & Sons, Ltd. es_ES
dc.rights info:eu-repo/semantics/openAccess
dc.subject Alzheimer Disease es_ES
dc.subject Enfermedad de Alzheimer es_ES
dc.subject Conjunto de Datos es_ES
dc.subject Dataset es_ES
dc.subject Population es_ES
dc.subject Población es_ES
dc.title Generating real-world evidence in Alzheimer's disease: Considerations for establishing a core dataset es_ES
dc.type info:eu-repo/semantics/article es_ES
dc.type info:eu-repo/semantics/publishedVersion
dc.description.fil Fil: Allegri, Ricardo Francisco. Fleni. Departamento de Neurología. Servicio de Neurología Cognitiva, Neuropsicología y Neuropsiquiatría; Argentina.
dc.relation.ispartofVOLUME 20
dc.relation.ispartofNUMBER 6
dc.relation.ispartofPAGINATION 4331-4341.
dc.relation.ispartofCOUNTRY Estados Unidos
dc.relation.ispartofCITY Hoboken
dc.relation.ispartofTITLE lzheimer's & dementia : the journal of the Alzheimer's Association
dc.relation.ispartofISSN 1552-5279
dc.type.snrd info:ar-repo/semantics/artículo es_ES


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