Perneczky Robert, Darby David, Frisoni Giovanni B, Hyde Robert, Iwatsubo Takeshi, Mummery Catherine J, Park Kee Hyung, van Beek Johan, van der Flier Wiesje M, Jessen Frank
Department of Psychiatry and Psychotherapy, LMU Hospital, Ludwig-Maximilians-Universität München, Munich, Germany; German Centre for Neurodegenerative Diseases (DZNE) Munich, Munich, Germany; Munich Cluster for Systems Neurology (SyNergy), Munich, Germany; Ageing Epidemiology Research Unit (AGE), School of Public Health, Imperial College London, London, UK; Division of Neuroscience, University of Sheffield, Sheffield, UK.
Department of Neurology, School of Translational Medicine, Monash University, Melbourne, Australia.
J Prev Alzheimers Dis. 2025 Apr;12(4):100096. doi: 10.1016/j.tjpad.2025.100096. Epub 2025 Feb 18.
Many dementia and Alzheimer's disease (AD) registries operate at local or national levels without standardization or comprehensive real-world data (RWD) collection. This initiative sought to achieve consensus among experts on priority outcomes and measures for clinical practice in caring for patients with symptomatic AD, particularly in the mild cognitive impairment and mild to moderate dementia stages.
The primary aim was to define a minimum dataset (MDS) and extended dataset (EDS) to collect RWD in the new International Registry for AD and Other Dementias (InRAD) and other AD registries. The MDS and EDS focus on informing routine clinical practice, covering relevant comorbidities and safety, and are designed to be easily integrated into existing data capture systems.
An international steering committee (ISC) of AD clinician experts lead the initiative. The first drafts of the MDS and EDS were developed based on a previous global inter-societal Delphi consensus on outcome measures for AD. Based on the ISC discussions, a survey was devised and sent to a wider stakeholder group. The ISC discussed the survey results, resulting in a consensus MDS and EDS covering: patient profile and demographics; lifestyle and anthropometrics; co-morbidities and diagnostics; imaging; treatment; clinical characterization; safety; discontinuation; laboratory tests; patient and care partner outcomes; and interface functionality.
By learning from successful examples in other clinical areas, addressing current limitations, and proactively enhancing data quality and analytical rigor, the InRAD registry will be a foundation to contribute to improving patient care and outcomes in neurodegenerative diseases.
许多痴呆症和阿尔茨海默病（AD）登记处仅在地方或国家层面运作，缺乏标准化且未进行全面的真实世界数据（RWD）收集。该倡议旨在就护理有症状AD患者（特别是在轻度认知障碍和轻度至中度痴呆阶段）的临床实践中的优先结局和测量指标，在专家之间达成共识。
主要目标是定义一个最小数据集（MDS）和扩展数据集（EDS），以便在新的国际AD和其他痴呆症登记处（InRAD）及其他AD登记处收集RWD。MDS和EDS专注于为常规临床实践提供信息，涵盖相关合并症和安全性，并且设计为易于整合到现有的数据采集系统中。
一个由AD临床专家组成的国际指导委员会（ISC）领导了该倡议。MDS和EDS的初稿是基于先前关于AD结局测量指标的全球跨学会德尔菲共识制定的。基于ISC的讨论，设计了一项调查并发送给更广泛的利益相关者群体。ISC讨论了调查结果，形成了一个共识性的MDS和EDS，涵盖：患者概况和人口统计学；生活方式和人体测量学；合并症和诊断；影像学；治疗；临床特征；安全性；停药；实验室检查；患者和护理伙伴结局；以及界面功能。
通过借鉴其他临床领域的成功范例，解决当前的局限性，并积极提高数据质量和分析严谨性，InRAD登记处将成为有助于改善神经退行性疾病患者护理和结局的基础。
