• Tjeerd-Pieter van Staa, Lisa Dyson, Gerard McCann, Shivani Padmanabhan, Rabah Belatri, Ben Goldacre, Jackie Cassell, Munir Pirmohamed, David Torgerson, Sarah Ronaldson, Joy Adamson, Adel Taweel, Brendan Delaney, Samhar Mahmood, Simona Baracaia, Thomas Round, Robin Fox, Tommy Hunter, Martin Gulliford, and Liam Smeeth.
• Department of Non-Communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.
• Health Technol Assess. 2014 Jul 1;18(43):1-146.

BackgroundPragmatic trials compare the effects of different decisions in usual clinical practice.ObjectivesTo develop and evaluate methods to implement simple pragmatic trials using routinely collected electronic health records (EHRs) and recruiting patients at the point of care; to identify the barriers and facilitators for general practitioners (GPs) and patients and the experiences of trial participants.DesignTwo exemplar randomised trials (Retropro and eLung) with qualitative evaluations.SettingFour hundred and fifty-nine English and Scottish general practices contributing EHRs to a research database, of which 17 participated in the trials.ParticipantsRetropro aimed to recruit 300 patients with hypercholesterolaemia and high cardiovascular risk and eLung aimed to recruit 150 patients with a chronic obstructive pulmonary disease exacerbation.InterventionsRetropro randomised between simvastatin and atorvastatin and eLung between immediate antibiotics and deferred or non-use. eLung recruited during an unscheduled consultation using EHR flagging.Main Outcome MeasureSuccessful trial completion with implementation of information technology (IT) system for flagging and data processing and documentation of operational and scientific experiences.Data SourcesEHR research database.ResultsThe governance approval process took over 3 years. A total of 58.8% of the practices (n = 270) expressed interest in participating. The number of interested practices dropped substantially with each stage of the governance process. In Retropro, 6.5% of the practices (n = 30) were eventually approved and 3.7% (n = 17) recruited patients; in eLung, these numbers were 6.8% (n = 31) and 1.3% (n = 6) respectively. Retropro successfully completed recruitment (301 patients) whereas eLung recruited 31 patients. Retropro recruited 20.6% of all statin starters in recruiting practices and 1.1% in the EHR database; the comparable numbers for eLung were 32.3% and 0.9% respectively. The IT system allowed for complex eligibility criteria with central on and off control of recruitment and flagging at a practice. Good Clinical Practice guidelines, governance and consent procedures were found to have substantially affected the intended simple nature of the trials. One qualitative study of 13 clinicians found that clinicians were generally positive about the principle of computerised trial recruitment (flagging during consultation). However, trials which did not include patients with acute illness were favoured. The second qualitative process evaluation interviewed 27 GPs about their actual experiences, including declining, recruiting and non-recruiting GPs. Opportunistic patient recruitment during a routine GP consultation was found to be the most controversial element. The actual experiences of recruiting patients during unscheduled consultation were generally more positive than the hypothetical views of GPs. Several of the recruiting GPs reported the process took 5 minutes and was straightforward and feasible on most occasions. Almost all GPs expressed their strong support for the use of EHRs for trials. Ten eLung participants were interviewed, all of whom considered it acceptable to be recruited during a consultation and to use EHRs for trials.ConclusionsEHR point-of-care trials are feasible, although the recruitment of clinicians is a major challenge owing to the complexity of trial approvals. These trials will provide substantial evidence on clinical effectiveness only if trial interventions and participating clinicians and patients are typical of usual clinical care and trials are simple to initiate and conduct. Recommendations for research include the development of evidence and implementation of risk proportionality in trial governance and conduct.Trial RegistrationCurrent Controlled Trials ISRCTN33113202 and ISRCTN72035428.FundingThis project was funded by the NIHR Health Technology Assessment programme and the Wellcome Trust and will be published in full in Health Technology Assessment; Vol. 18, No. 43. See the NIHR Journals Library website for further project information.

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