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Building a recruitment database for asthma trials: a conceptual framework for the creation of the UK Database of Asthma Research Volunteers

Nwaru, Bright I.; Soyiri, Ireneous N.; Simpson, Colin R.; Griffiths, Chris; Sheikh, Aziz

Authors

Bright I. Nwaru

Colin R. Simpson

Chris Griffiths

Aziz Sheikh



Contributors

Abstract

Background
Randomised clinical trials are the ‘gold standard’ for evaluating the effectiveness of healthcare interventions. However, successful recruitment of participants remains a key challenge for many trialists. In this paper, we present a conceptual framework for creating a digital, population-based database for the recruitment of asthma patients into future asthma trials in the UK. Having set up the database, the goal is to then make it available to support investigators planning asthma clinical trials.

Methods
The UK Database of Asthma Research Volunteers will comprise a web-based front-end that interactively allows participant registration, and a back-end that houses the database containing participants’ key relevant data. The database will be hosted and maintained at a secure server at the Asthma UK Centre for Applied Research based at The University of Edinburgh. Using a range of invitation strategies, key demographic and clinical data will be collected from those pre-consenting to consider participation in clinical trials. These data will, with consent, in due course, be linkable to other healthcare, social, economic, and genetic datasets. To use the database, asthma investigators will send their eligibility criteria for participant recruitment; eligible participants will then be informed about the new trial and asked if they wish to participate. A steering committee will oversee the running of the database, including approval of usage access. Novel communication strategies will be utilised to engage participants who are recruited into the database in order to avoid attrition as a result of waiting time to participation in a suitable trial, and to minimise the risk of their being approached when already enrolled in a trial.

Results
The value of this database will be whether it proves useful and usable to researchers in facilitating recruitment into clinical trials on asthma and whether patient privacy and data security are protected in meeting this aim.

Conclusions
Successful recruitment is fundamental to the success of a clinical trial. The UK Database of Asthma Research Volunteers, the first of its kind in the context of asthma, presents a novel approach to overcoming recruitment barriers and will facilitate the catalysing of important clinical trials on asthma in the UK.

Citation

Nwaru, B. I., Soyiri, I. N., Simpson, C. R., Griffiths, C., & Sheikh, A. (2016). Building a recruitment database for asthma trials: a conceptual framework for the creation of the UK Database of Asthma Research Volunteers. Trials, 17(1), Article 264. https://doi.org/10.1186/s13063-016-1381-6

Journal Article Type Article
Acceptance Date May 3, 2016
Online Publication Date May 26, 2016
Publication Date 2016
Deposit Date May 15, 2019
Publicly Available Date May 16, 2019
Journal Trials
Print ISSN 1745-6215
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 17
Issue 1
Article Number 264
DOI https://doi.org/10.1186/s13063-016-1381-6
Keywords Asthma; Clinical trials; Electronic health records; Data linkage; Recruitment database
Public URL https://hull-repository.worktribe.com/output/1740771
Publisher URL https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1381-6
Contract Date May 16, 2019

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Copyright Statement
© 2016 Nwaru et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.






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