Pragmatic randomised clinical trials using electronic health records: general practitioner views on a model of a priori consent

Trials
Thomas HillsRichard Beasley

Abstract

Pragmatic randomised clinical trials could use existing electronic health records (EHRs) to identify trial participants, perform randomisation, and to collect follow-up data. Achieving adequate informed consent in routine care and clinician recruitment have been identified as key barriers to this approach to clinical trials. We propose a model where written informed consent for a pragmatic comparative effectiveness trial is obtained in advance by the research team, recorded in the EHR, and then confirmed by the general practitioner (GP) at the time of enrolment. The EHR software then randomly assigns a patient to one of two treatments. Follow-up data is collected in the EHR. Twenty-two of 23 GPs surveyed (96%) were 'definitely' or 'probably' comfortable with confirming consent. Twenty-one out of 23 GPs (91%) were 'definitely' or 'probably' comfortable with a patient being randomised to one of two comparable drugs during a routine consultation. Twenty-two out of 23 GPs (96%) were 'definitely' or 'probably' comfortable with allowing the electronic system to randomise a patient to drug A or drug B and generate a prescription. Ten out of 23 GPs (43%) identified time constraints as the main hurdle to conducting this sort of research...Continue Reading

References

Feb 9, 2012·BMJ : British Medical Journal·Tjeerd-Pieter van StaaLiam Smeeth
Feb 21, 2014·The New England Journal of Medicine·Ruth R FadenNancy E Kass
May 10, 2015·BMJ : British Medical Journal·Kirsty LoudonMerrick Zwarenstein
Aug 16, 2016·The New England Journal of Medicine·Ian Ford, John Norrie

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Citations

Mar 29, 2019·BMJ : British Medical Journal·Rafael Dal-RéShaun Treweek
Feb 19, 2019·Journal of Clinical and Translational Science·Andrew L SussmanMark R Burge

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Clinical Trials Mentioned

ISRCTN33113202
ISRCTN72035428

Software Mentioned

REDCap

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