REAl world Dementia OUTcomes (READ-OUT) protocol: observational study.
Whiteside DJ., Yang Y., Begde A., Rome-Hall H., Koohi F., Koychev I., Raymont V., Rowe JB., READ-OUT study group .
INTRODUCTION: Developments in blood biomarkers (BBMs) in dementia call for studies that evaluate their diagnostic, prognostic and societal implications in real-world populations. Such evidence is essential to support the safe and effective integration of BBMs into clinical practice. METHODS AND ANALYSIS: The REAl world Dementia OUTcomes study (READ-OUT) is a UK-based, multi-site study that assesses the prognostic and diagnostic utility of BBMs in people attending memory assessment services ('secondary care'). READ-OUT phase 1 is a 3-year observational study of 3165 people representative of the UK population, with up-sampling of under-represented groups and proactive recruitment to include individuals missing from secondary care memory services. Participants are over the age of 45, able to provide a blood sample and willing to consent to linkage with electronic health records. The baseline study visit includes venepuncture and questionnaire assessment of quality of life and health resource usage. A subsample of the full cohort will have further venepuncture and questionnaires at a 52-week follow-up. READ-OUT substudies will evaluate BBMs' test-retest reliability, the impact of processing delays and the feasibility of self-collected blood-spot samples. The clinical utility of BBMs will be assessed against diagnosis, outcomes from electronic health records, corollary data and health economic data. Results of the observational study discussed in this protocol will inform the design of a randomised controlled trial to test the cost-effectiveness, acceptability and clinical utility of disclosed BBM results. ETHICS AND DISSEMINATION: The study has received Research Ethics Committee approval (REC reference 24/WA/0330) and approval through the Health Research Authority/Health and Care Research Wales (IRAS project 342412). Anonymised study data will be stored on the Dementia Platform UK (DPUK) Data Portal (https://portal.dementiasplatform.uk) and made available through a managed access process, subject to the DPUK Data Access Agreement.