The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records: evaluations of two exemplar trials

van Staa TP, Dyson L, McCann G, Padmanabhan S, Belatri R, Goldacre B, Cassell J, Pirmohamed M, Torgerson D, Ronaldson S, Adamson J, Taweel A, Delaney B, Mahmood S, Baracaia S, Round T, Fox R, Hunter T, Gulliford M, Smeeth L
Record ID 32014000921
English
Authors' objectives: 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.
Authors' recommendations: 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.
Details
Project Status: Completed
Year Published: 2014
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: England, United Kingdom
MeSH Terms
  • Adult
  • Ambulatory Care
  • Electronic Health Records
  • Evaluation Studies as Topic
  • Feasibility Studies
  • Female
  • General Practitioners
  • Male
  • Middle Aged
  • Patient Selection
  • Anticholesteremic Agents
  • Heptanoic Acids
  • Pragmatic Clinical Trials as Topic
  • Pyrroles
  • Simvastatin
Contact
Organisation Name: NIHR Health Technology Assessment programme
Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name: journals.library@nihr.ac.uk
Contact Email: journals.library@nihr.ac.uk
Copyright: Queen's Printer and Controller of HMSO
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.