key: cord-1002830-evhv9b3b
authors: Kotting, Piers; Smith, Adam; O'Hare, Megan B.; Giebel, Clarissa; Mendis, Lakshini; Shaw, Clare; Shillito, Imogen; Rossor, Martin N.
title: A national open‐access research registry to improve recruitment to clinical studies
date: 2021-12-09
journal: Alzheimers Dement (N Y)
DOI: 10.1002/trc2.12221
sha: 2b2e37722ae7804f7a9a3de42d58f1cf0ce05808
doc_id: 1002830
cord_uid: evhv9b3b

INTRODUCTION: Barriers to recruitment for dementia studies are well documented. As part of the UK government's Dementia 2020 strategy, a nationally consistent system to increase public engagement and participation in research was launched in February 2015. METHODS: We describe the development of the “Join Dementia Research” registry, including evolution of policy, involvement of people with dementia in co‐production, data requirements, governance, technology, and the impact on study recruitment and what factors may have contributed to the services success. RESULTS: The UK‐wide online, telephone, and postal service has registered 47,071 volunteers, with 33,139 people (67.9% of all volunteers) taking part in 378 studies, with 49,954 total study enrolments. This has taken place across 295 research sites, involved 1522 researchers, and resulted in 134 peer‐reviewed publications. DISCUSSION: Public registries of individuals interested in research, with user‐provided data enabling basic phenotyping, are effective at increasing public engagement with research and removing barriers to study recruitment. Deeper pheno/genotyping could be undertaken to improve matching, but how and when that information is collected will be a key factor.

1. Systematic Review: The authors reviewed the literature using traditional sources (PubMed and Google Scholar) and had personal communications with authors and conducted analysis on data held within the Join Dementia Research (JDR) registry.

2. Interpretation: JDR has successfully registered more than 49,000 people, with > 33,000 going on to take part in at least one study. JDR has been widely adopted with more than 1500 researchers using the service across 295 sites to enroll to 378 studies. This demonstrates the feasi- independently of the exclusion criteria, 4 while also being under pressure to balance recruitment for simultaneous trials leading to competition for participants. 7 In response to these barriers, patient registries have been used in many diseases to support research 8 and registries have evolved to support dementia research. 9 We report the development, implementation, and initial outcomes of the Join Dementia Research (JDR) service, a national dementia research registry in the UK.

JDR was developed by the Dementias and Neurodegenerative Dis- 

People affected by dementia, both those with a diagnosis and family carers, were central to the development and delivery of JDR. An "insider" approach 12 was adopted, with people affected by dementia involved in the co-production of all areas of the project (consul- champions across the UK were media trained and supported to deliver regional and national public relations. This "Champions" network continues to play a vital role in the promotion of the service through press and social media engagement nationally.

JDR is a matchmaking service between people interested in participating in dementia research and researchers. It is provided through a partnership between the National Institute for Health Research (NIHR) in England, Alzheimer's Research UK, Alzheimer's Society, and Alzheimer

Scotland. The service and dataset are illustrated in Figure 1 .

Any member of the public aged 18 years or over, with or without dementia, is encouraged to register via the website, charity-managed telephone helplines, or a free postal application form. Registration involves providing 18 mandatory data items, and up to 30 optional items, depending on diagnosis. Data in JDR is maintained as accurate by the volunteers and by researchers who are responsible for recording any changes to a volunteer's data when they are speaking to them about a specific study. Researchers define the matching criteria for their studies based on the study protocol and volunteer-provided data fields-supporting multiple study arms and sites for the same study.

The unique element of this service is the "real-time" matching, which gives researchers direct access to volunteers, who are contacted via telephone and e-mail for further screening. At any one time, 300+ studies, operating at 100+ different sites, can be simultaneously using the service, and drawing on the same volunteers. Moreover, volunteers are made aware of all studies for which they are provisionally eligible.

The primary responsibility for national promotion of JDR sits with the NIHR Clinical Research Network Coordinating Centre (CRNCC), three charity partners, and the National Health Service (NHS). A network of public JDR Champions is supported by the CRNCC and supports communications locally and nationally. Promotional activities aimed at volunteers have three core audiences: the general public including people with dementia, health service staff, and organizational partners.

Since There has been a corresponding rise in the proportion of volunteers with dementia from an average of 7.1% across the first year to 11.5%

in June 2021. The COVID-19 pandemic has had a dramatic effect on volunteering rates, primarily due to NHS services moving to online or closing during periods of national lockdown.

Eighty percent of volunteers register online, with 10% via the charity helplines and 10% via post. Table 1 summarizes the source of volunteers from different channels/activities since JDR was launched. The larger sources of all volunteers have been health-care, including general practioners, provider trusts, and pharmacies (23%); the charity partners (22%); and news items from public relations activities (18%; Table 1 ). These data are self-reported by volunteers when they register, and the source categories are not necessarily mutually exclusive.

As such, they provide an indication of source rather than an absolute measurement.

Volunteers can select multiple diagnoses from a pre-defined list when registering. Table 2 shows the breakdown of diagnoses recorded. These diagnoses are self-reported and non-verified through clinical data or further investigation; however, diagnoses will be confirmed by the researcher for a specific study. A further 2407 volunteers have registered as having dementia but not being aware of their specific diagnosis (not included as "people with dementia" in the data reported in this article JDR has attracted large numbers of volunteers without a dementia diagnosis in an age range that makes them valuable for screening for high risk and pre-clinical studies. There are several ongoing initiatives globally to create cohorts in a similar population to support prevention and early intervention research. 16, 17, 20, 21, 27 These studies typically seek deeper phenotypic and genotypic characterization of par-ticipants than is available on JDR. However, to date, collection of additional data has not resulted in increased recruitment to trials. A next step for JDR is to consider the value of collecting additional data, or integrating with other systems that already have these data, for example, NHS Records, Dementias Platform UK. However, the aim will be to do this digitally through tools such as online cognitive assessments, specific to each study through the form of pre-screening assessments.

The In initial pilot work prior to the development of JDR, rate of registration of people with a diagnosis was 30%, although this was a twostage consent process and was recorded directly into a local clinical system, which may be a key facilitator compared to current JDR practice in which volunteers have to self-register.

An alternative way to increase rates of registration of people with dementia is to integrate a simple one-stage consent process into core clinical pathways, with consent recorded electronically in electronic health records and shared with JDR. Rates of consent have been shown to be as high as 73% for patients consenting to register in mental health trusts in England. 22 There are a range of external factors impacting the success of JDR, such as social factors, including perceptions and public attitudes to research, health-care professionals, and researchers. Many people believe that dementia is a normal part of aging 1 so may not see it as an important focus of research. There are several existing local research recruitment mechanisms, including local registries, that may act as a barrier to uptake of JDR. While these support recruitment to local studies, they do not provide the breadth of access and choice to patients. Researchers may also take a "study-centric" approach, using local mechanisms to recruit to a study, which also limits patient access to research and choice.

Registrations of people with and without diagnosis have reduced significantly as a result of the COVID-19 pandemic. One reason for this, particularly relating to registration of people with dementia, is memory clinics being conducted virtually during the initial UK lockdown and the resulting reduction in diagnosis rates. 23, 24 The refocus on delivery of COVID-19 research across the NIHR has also likely reduced the volume of marketing activity reducing the number of all registrations (see Figure 3 ). However, JDR has contributed to COVID-19 research, recruiting 6719 into COVID-19-related dementia studies. Additionally, in the long term, the perceived importance of research and its value has improved in the last 18 months; the Wellcome Trust Monitor report from 2020 shows that two in three people now feel health research has positively impacted their life. 26 JDR is a live service that has had a sizeable impact on the dementia research landscape in the UK when judged by the scale of uptake (number of people registering and use by researchers), and the level of impact (number of people enrolled into studies and the proportion of overall enrolment delivered by JDR). However, it has some limitations such as richness of phenotypic data, which will need to be addressed if it is to continue to meet the needs of dementia research and be sustainable in the future.

The authors thank the people who have signed up to JDR as volunteers and the people who have become JDR champions to promote the register. We also thank the people working across the public, third, and 

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The authors report no conflicts, other than the NIHR infrastructure grant to create the JDR system. Martin N. Rossor https://orcid.org/0000-0001-8215-3120