Dutch Brain Research Registry for study participant recruitment: Design and first results

Zwan, Marissa D.; Flier, Wiesje M. van der; Cleutjens, Solange; Schouten, Tamara C; Vermunt, Lisa; Jutten, Roos J.; Maurik, Ingrid S. van; Sikkes, Sietske A.M.; Flenniken, Derek; Howell, Taylor; Weiner, Michael W.; Scheltens, Philip; Prins, Niels D.

doi:10.1002/trc2.12132

Cited by 38 publications

(34 citation statements)

References 24 publications

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“…For the clinical validation, we selected 40 participants with AD dementia from the Amsterdam Dementia Cohort [ 19 , 20 ] (average±standard deviation (SD) age 66±8 years, n = 20 (50%) female), who were diagnosed according the NIA-AA diagnostic AD criteria [ 21 ] and had a CSF biomarker-confirmed AD diagnosis. We selected 40 age- and sex-matched (age 66±8 years, n = 20 (50%) female) cognitively healthy control participants from the Dutch Brain Research Registry (Hersenonderzoek.nl; CSF AD biomarker status unknown) [ 22 ]. The minimal sample size required was calculated based on three different studies, one study for each of the three P-tau forms that were measured in our study (P-tau181, P-tau217, P-tau231) [ 4 , 11 , 23 ].…”

Section: Methodsmentioning

confidence: 99%

Clinical and analytical comparison of six Simoa assays for plasma P-tau isoforms P-tau181, P-tau217, and P-tau231

et al. 2021

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Introduction Studies using different assays and technologies showed highly promising diagnostic value of plasma phosphorylated (P-)tau levels for Alzheimer’s disease (AD). We aimed to compare six P-tau Simoa assays, including three P-tau181 (Eli Lilly, ADx, Quanterix), one P-tau217 (Eli Lilly), and two P-tau231 (ADx, Gothenburg). Methods We studied the analytical (sensitivity, precision, parallelism, dilution linearity, and recovery) and clinical (40 AD dementia patients, age 66±8years, 50%F; 40 age- and sex-matched controls) performance of the assays. Results All assays showed robust analytical performance, and particularly P-tau217 Eli Lilly; P-tau231 Gothenburg and all P-tau181 assays showed robust clinical performance to differentiate AD from controls, with AUCs 0.936–0.995 (P-tau231 ADx: AUC = 0.719). Results obtained with all P-tau181 assays, P-tau217 Eli Lilly assay, and P-tau231 Gothenburg assay strongly correlated (Spearman’s rho > 0.86), while correlations with P-tau231 ADx results were moderate (rho < 0.65). Discussion P-tau isoforms can be measured robustly by several novel high-sensitive Simoa assays.

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Section: Methodsmentioning

confidence: 99%

Clinical and analytical comparison of six Simoa assays for plasma P-tau isoforms P-tau181, P-tau217, and P-tau231

et al. 2021

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“…This article focuses on the retention of participants rather than the recruitment process. There are enough studies, for example, recruitment via direct mail 72 or online social media campaign 73 and online enrollment of potential participants. 74 75 The retention and the reduction of loss to follow-up are crucial in studies with a long follow-up period.…”

Section: Discussionmentioning

confidence: 99%

Designing and Implementing an IT Architecture for a Digital Multicenter Dementia Registry: digiDEM Bayern

et al. 2021

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Background Registries are an essential research tool to investigate the long-term course of diseases and their impact on the affected. The project digiDEM Bayern will set up a prospective dementia registry to collect long-term data of people with dementia and their caregivers in Bavaria (Germany) supported by more than 300 research partners. Objective The objective of this article is to outline an information technology (IT) architecture for the integration of a registry and comprehensive participant management in a dementia study. Measures to ensure high data quality, study governance, along with data privacy, and security are to be included in the architecture. Methods The architecture was developed based on an iterative, stakeholder-oriented process. The development was inspired by the Twin Peaks Model that focuses on the codevelopment of requirements and architecture. We gradually moved from a general to a detailed understanding of both the requirements and design through a series of iterations. The experience learned from the pilot phase was integrated into a further iterative process of continuous improvement of the architecture. Results The infrastructure provides a standardized workflow to support the electronic data collection and trace each participant's study process. Therefore, the implementation consists of three systems: (1) electronic data capture system for Web-based or offline app-based data collection; (2) participant management system for the administration of the identity data of participants and research partners as well as of the overall study governance process; and (3) videoconferencing software for conducting interviews online. First experiences in the pilot phase have proven the feasibility of the framework. Conclusion This article outlines an IT architecture to integrate a registry and participant management in a dementia research project. The framework was discussed and developed with the involvement of numerous stakeholders. Due to its adaptability of used software systems, a transfer to other projects should be easily possible.

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“…The Dutch Brain Research Registry ( Hersenonderzoek.nl in Dutch) [ 62 ] was set up in 2017 with the aim to accelerate recruitment of participants for current and future clinical brain disease studies in the Netherlands. To date, over 20.000 participants signed up (58±11 years old, 78% female).…”

Section: Evidence On Communicating Dementia Riskmentioning

confidence: 99%

Dementia risk communication. A user manual for Brain Health Services—part 3 of 6

et al. 2021

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Growing evidence suggests dementia incidence can be reduced through prevention programs targeting risk factors. To accelerate the implementation of such prevention programs, a new generation of brain health services (BHS) is envisioned, involving risk profiling, risk communication, risk reduction, and cognitive enhancement. The purpose of risk communication is to enable individuals at risk to make informed decisions and take action to protect themselves and is thus a crucial step in tailored prevention strategies of the dementia incidence. However, communicating about dementia risk is complex and challenging.In this paper, we provide an overview of (i) perspectives on communicating dementia risk from an ethical, clinical, and societal viewpoint; (ii) insights gained from memory clinical practice; (iii) available evidence on the impact of disclosing APOE and Alzheimer’s disease biomarker test results gathered from clinical trials and observational studies; (iv) the value of established registries in light of BHS; and (v) practical recommendations regarding effective strategies for communicating about dementia risk.In addition, we identify challenges, i.e., the current lack of evidence on what to tell on an individual level—the actual risk—and on how to optimally communicate about dementia risk, especially concerning worried yet cognitively unimpaired individuals. Ideally, dementia risk communication strategies should maximize the desired impact of risk information on individuals’ understanding of their health/disease status and risk perception and minimize potential harms. More research is thus warranted on the impact of dementia risk communication, to (1) evaluate the merits of different approaches to risk communication on outcomes in the cognitive, affective and behavioral domains, (2) develop an evidence-based, harmonized dementia risk communication protocol, and (3) develop e-tools to support and promote adherence to this protocol in BHSs.Based on the research reviewed, we recommend that dementia risk communication should be precise; include the use of absolute risks, visual displays, and time frames; based on a process of shared decision-making; and address the inherent uncertainty that comes with any probability.

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Dutch Brain Research Registry for study participant recruitment: Design and first results

Cited by 38 publications

References 24 publications

Clinical and analytical comparison of six Simoa assays for plasma P-tau isoforms P-tau181, P-tau217, and P-tau231

Clinical and analytical comparison of six Simoa assays for plasma P-tau isoforms P-tau181, P-tau217, and P-tau231

Designing and Implementing an IT Architecture for a Digital Multicenter Dementia Registry: digiDEM Bayern

Dementia risk communication. A user manual for Brain Health Services—part 3 of 6

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