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

• Published in: Health technology assessment (Winchester, England) England), 2014-07, Vol.18 (43), p.1-146
• Main Authors: van Staa, Tjeerd-Pieter, Dyson, Lisa, McCann, Gerard, Padmanabhan, Shivani, Belatri, Rabah, Goldacre, Ben, Cassell, Jackie, Pirmohamed, Munir, Torgerson, David, Ronaldson, Sarah, Adamson, Joy, Taweel, Adel, Delaney, Brendan, Mahmood, Samhar, Baracaia, Simona, Round, Thomas, Fox, Robin, Hunter, Tommy, Gulliford, Martin, Smeeth, Liam
• Format: Article
• Language: English
• Subjects: Adult; Ambulatory Care; Anticholesteremic Agents - therapeutic use; Atorvastatin; Databases, Factual; Electronic Health Records; elung; Evaluation Studies as Topic; Feasibility Studies; Female; General Practitioners; good clinical practice; Heptanoic Acids - therapeutic use; Humans; Male; Middle Aged; Patient Selection; point of care; Pragmatic Clinical Trials as Topic - methods; Pyrroles - therapeutic use; retropro; Simvastatin - therapeutic use
• ISSN: 1366-5278; 2046-4924
• DOI: 10.3310/hta18430

Pragmatic trials compare the effects of different decisions in usual clinical practice. 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. Two exemplar randomised trials (Retropro and eLung) with qualitative evaluations. Four hundred and fifty-nine English and Scottish general practices contributing EHRs to a research database, of which 17 participated in the trials. 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. 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. Successful trial completion with implementation of information technology (IT) system for flagging and data processing and documentation of operational and scientific experiences. EHR research database. 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 a