title: The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records: evaluations of two exemplar trials.
abstract: BACKGROUND
  Pragmatic trials compare the effects of different decisions in usual clinical practice.
  
  
  OBJECTIVE
  To 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.
  
  
  METHODS
  Two exemplar randomised trials (Retropro and eLung) with qualitative evaluations.
  
  
  METHODS
  Four hundred and fifty-nine English and Scottish general practices contributing EHRs to a research database, of which 17 participated in the trials.
  
  
  METHODS
  Retropro 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.
  
  
  METHODS
  Retropro randomised between simvastatin and atorvastatin and eLung between immediate antibiotics and deferred or non-use. eLung recruited during an unscheduled consultation using EHR flagging.
  
  
  METHODS
  Successful trial completion with implementation of information technology (IT) system for flagging and data processing and documentation of operational and scientific experiences.
  
  
  METHODS
  EHR research database.
  
  
  RESULTS
  The 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.
  
  
  CONCLUSIONS
  EHR 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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN33113202 and ISRCTN72035428.
  
  
  BACKGROUND
  This 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.
authors.affiliation: Department of Non-Communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: Tjeerd-Pieter
authors.initials: TP
authors.lastname: van Staa
authors.affiliation: York Trials Unit, York University, York, UK.
authors.forename: Lisa
authors.initials: L
authors.lastname: Dyson
authors.affiliation: Clinical Practice Research Datalink, Medicines and Healthcare products Regulatory Agency, London, UK.
authors.forename: Gerard
authors.initials: G
authors.lastname: McCann
authors.affiliation: Clinical Practice Research Datalink, Medicines and Healthcare products Regulatory Agency, London, UK.
authors.forename: Shivani
authors.initials: S
authors.lastname: Padmanabhan
authors.affiliation: Clinical Practice Research Datalink, Medicines and Healthcare products Regulatory Agency, London, UK.
authors.forename: Rabah
authors.initials: R
authors.lastname: Belatri
authors.affiliation: Department of Non-Communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: Ben
authors.initials: B
authors.lastname: Goldacre
authors.affiliation: Division of Primary Care and Public Health, Brighton and Sussex Medical School, University of Brighton, Brighton, UK.
authors.forename: Jackie
authors.initials: J
authors.lastname: Cassell
authors.affiliation: The Wolfson Centre for Personalised Medicine, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.
authors.forename: Munir
authors.initials: M
authors.lastname: Pirmohamed
authors.affiliation: York Trials Unit, York University, York, UK.
authors.forename: David
authors.initials: D
authors.lastname: Torgerson
authors.affiliation: York Trials Unit, York University, York, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Ronaldson
authors.affiliation: York Trials Unit, York University, York, UK.
authors.forename: Joy
authors.initials: J
authors.lastname: Adamson
authors.affiliation: Department of Primary Care and Public Health Sciences Division of Health and Social Care Research, King's College London, London, UK.
authors.forename: Adel
authors.initials: A
authors.lastname: Taweel
authors.affiliation: Department of Primary Care and Public Health Sciences Division of Health and Social Care Research, King's College London, London, UK.
authors.forename: Brendan
authors.initials: B
authors.lastname: Delaney
authors.affiliation: Department of Primary Care and Public Health Sciences Division of Health and Social Care Research, King's College London, London, UK.
authors.forename: Samhar
authors.initials: S
authors.lastname: Mahmood
authors.affiliation: Department of Primary Care and Public Health Sciences Division of Health and Social Care Research, King's College London, London, UK.
authors.forename: Simona
authors.initials: S
authors.lastname: Baracaia
authors.affiliation: Department of Primary Care and Public Health Sciences Division of Health and Social Care Research, King's College London, London, UK.
authors.forename: Thomas
authors.initials: T
authors.lastname: Round
authors.affiliation: The Health Centre, Bicester, UK.
authors.forename: Robin
authors.initials: R
authors.lastname: Fox
authors.affiliation: Barns Medical Practice, Ayr, UK.
authors.forename: Tommy
authors.initials: T
authors.lastname: Hunter
authors.affiliation: Primary Care and Public Health Sciences, King's College London, London, UK.
authors.forename: Martin
authors.initials: M
authors.lastname: Gulliford
authors.affiliation: Department of Non-Communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: Liam
authors.initials: L
authors.lastname: Smeeth
mesh_terms: D000328:Adult; D000553:Ambulatory Care; D000924:Anticholesteremic Agents / Q000627:therapeutic use; D000069059:Atorvastatin; D016208:Databases, Factual; D057286:Electronic Health Records; D005069:Evaluation Studies as Topic; D005240:Feasibility Studies; D005260:Female; D058005:General Practitioners; D006538:Heptanoic Acids / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D064792:Pragmatic Clinical Trials as Topic / Q000379:methods*; D011758:Pyrroles / Q000627:therapeutic use; D019821:Simvastatin / Q000627:therapeutic use
chemical_list: D000924:Anticholesteremic Agents; D006538:Heptanoic Acids; D011758:Pyrroles; D000069059:Atorvastatin; D019821:Simvastatin