Using routinely recorded data in the UK to assess outcomes in a randomised controlled trial: The Trials of Access View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2017-08-23

AUTHORS

G. A. Powell, L. J. Bonnett, C. Tudur-Smith, D. A. Hughes, P. R. Williamson, A. G. Marson

ABSTRACT

BackgroundIn the UK, routinely recorded data may benefit prospective studies including randomised controlled trials (RCTs). In an on-going study, we aim to assess the feasibility of access and agreement of routinely recorded clinical and non-clinical data compared to data collected during a RCT using standard prospective methods. This paper will summarise available UK routinely recorded data sources and discuss our experience with the feasibility of accessing routinely recorded data for participants of a RCT before finally proposing recommendations for improving the access and implementation of routinely recorded data in RCTs.MethodsSetting: the case study RCT is the Standard and New Antiepileptic Drugs II (SANAD II) trial, a pragmatic, UK, multicentre, phase IV RCT assessing the clinical and cost-effectiveness of antiepileptic drug treatments for newly diagnosed epilepsy.Participants: 98 participants have provided written consent to permit the request of routinely recorded data.Study procedures: routinely recorded clinical and non-clinical data were identified and data requested through formal applications from available data holders for the duration that participants have been recruited into SANAD II. The feasibility of accessing routinely recorded data during a RCT is assessed and recommendations for improving access proposed.ResultsSecondary-care clinical and socioeconomic data is recorded on a national basis and can be accessed, although there are limitations in the application process. Primary-care data are recorded by a number of organisations on a de-identified basis but access for specific individuals has not been feasible. Access to data recorded by non-clinical sources, including The Department for Work and Pensions and The Driving and Vehicle Licensing Agency, was not successful.ConclusionsRecommendations discussed include further research to assess the attributes of routinely recorded data, an assessment of public perceptions and the development of strategies to collaboratively improve access to routinely recorded data for research.Trial registrationInternational Standard Randomised Controlled Trials, ISRCTN30294119. Registered on 3 July 2012. EudraCT No: 2012-001884-64. Registered on 9 May 2012. More... »

PAGES

389

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s13063-017-2135-9

DOI

http://dx.doi.org/10.1186/s13063-017-2135-9

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1091306167

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/28835254


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