Fox Insight at 5 years - a cohort of 54,000 participants contributing longitudinal patient-reported outcome, genetic, and microbiome data relating to Parkinson's disease.

Fox Insight is an online, longitudinal study of over 54,000 people with and without Parkinson's disease, facilitating discovery, validation, and reproducibility in Parkinson's disease research. The study administers routine longitudinal assessments, one-time questionnaires on an array of topics such as environmental exposure or COVID-19, plus genetic and microbiome data collection. Researchers can explore and download patient-reported outcomes data and Parkinson's disease related genetic variants upon completing a Data Use Agreement. The full genetic data set, including approximately 650,000 single nucleotide polymorphisms for over 10,000 participants, and the microbiome data set for over 650 participants, can be requested with a heightened level of access. Since the first Fox Insight data descriptor was published in 2020, the data captured has been extended significantly, so this paper supersedes the previous one. Since then, the number of participants has increased by more than 20,000; an additional 1,747,729 surveys were completed; 130 gigabytes of genetic data were released; responses from 16 new one-time surveys were collected; and, data from one additional sub-study was made available.

Patient and Public Involvement and Engagement in the Development of a Platform Clinical Trial for Parkinson's Disease: An Evaluation Protocol.

Background: Patient and public involvement and engagement (PPIE) in the design of trials is important, as participant experience critically impacts delivery. The Edmond J Safra Accelerating Clinical Trials in PD (EJS ACT-PD) initiative is a UK consortium designing a platform trial for disease modifying therapies in PD. Objective: The integration of PPIE in all aspects of trial design and its evaluation throughout the project. Methods: PwP and care partners were recruited to a PPIE working group (WG) via UK Parkinson's charities, investigator patient groups and participants of a Delphi study on trial design. They are supported by charity representatives, trial delivery experts, researchers and core project team members. PPIE is fully embedded within the consortium's five other WGs and steering group. The group's terms of reference, processes for effective working and PPIE evaluation were co-developed with PPIE contributors. Results: 11 PwP and 4 care partners have supported the PPIE WG and contributed to the development of processes for effective working. A mixed methods research-in-action study is ongoing to evaluate PPIE within the consortium. This includes the Patient Engagement in Research Scale -a quantitative PPIE quality measure; semi-structured interviews -identifying areas for improvement and overall impressions of involvement; process fidelity- recording adherence; project documentation review - identifying impact of PPIE on project outputs. Conclusions: We provide a practical example of PPIE in complex projects. Evaluating feasibility, experiences and impact of PPIE involvement in EJS ACT-PD will inform similar programs on effective strategies. This will help enable future patient-centered research.