Real-world datasets for the International Registry for Alzheimer’s Disease and Other Dementias (InRAD) and other registries: an international consensus

BACKGROUND 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.

AND RESULTS 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. Competing Interest Statement RP has received research grants from Roche, Astra Zeneca, Bayer, Takeda and GE. He has received speaker and consultancy honoraria from Roche, Eisai, Biogen, Janssen-Cilag, Lilly, GE, AstraZeneca, Grifols, Novo Nordisk, Abbvie and GSK. RP is a the founding chairman of the board of InRAD Foundation, which is supported by Lilly, Biogen, Novo Nordisk and GSK. FJ received a research grant from Roche and honoraria for presentations and consultancy services from Abbvie, AC immune, Biogen, Eli Lilly, Eisai, GE Healthcare, Grifols, Janssen-Cliag and Roche. FJ is a founding member of the board of InRAD Foundation. DD has received honoraria as a clinical lecturer and funding received support for investigator-initiated studies (or clinical meetings) from Biogen, Merck, Novartis, Lilly and Nutricia. He is a founder of Cogstate Ltd but retains no commercial or stock interest in this company. He is an independent software developer of medical applications with CereScape P/L. CJM has served on advisory boards or consulted for Biogen, Roche, WAVE, IONIS, Prevail, Eli Lilly, Novartis, Neuroimmune, AviadoBio, GSK, MSD and Eisai. She received an investigator grant from Biogen for the development of ultrafast MRI. She has received honoraria for lectures at sponsored symposia for Biogen, Roche, EISAI, IONIS, Lilly. She is supported by the UCLH Biomedical Research Centre. RH, JVB, GF, TI, KHP and WMF have no disclosures. Funding Statement Eli Lilly and Company funded the involvement of TW1 Healthcare Consulting Limited, but did not have any influence over the consensus process outside of their inclusion in the stakeholder involvement. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Footnotes Reviewer comments were addressed in the revised version of the manuscript, including adding details about the methodology used to define the minimum and extended datasets. Data Availability All data produced in the present study are available upon reasonable request to the authors