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Analysis

Pragmatic randomised trials using routine electronic health records: putting them to the test

BMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e55 (Published 07 February 2012) Cite this as: BMJ 2012;344:e55
  1. Tjeerd-Pieter van Staa, head of research and honorary professor of epidemiology123,
  2. Ben Goldacre, research fellow3,
  3. Martin Gulliford, professor of public health4,
  4. Jackie Cassell, professor of primary care epidemiology5,
  5. Munir Pirmohamed, NHS chair of pharmacogenetics6,
  6. Adel Taweel, senior lecturer in software engineering4,
  7. Brendan Delaney, Guy’s and St Thomas’ charity chair in primary care research4,
  8. Liam Smeeth, professor of clinical epidemiology3
  1. 1General Practice Research Database (GPRD), Medicines and Healthcare products Regulatory Agency, 151 Buckingham Palace Road, London SW1W 9SZ, UK
  2. 2Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands
  3. 3London School of Hygiene and Tropical Medicine, London, UK
  4. 4Department of Primary Care and Public Health Science, King’s College, London, UK
  5. 5Division of Primary Care and Public Health, Brighton and Sussex Medical School, University of Brighton, Brighton, UK
  6. 6Wolfson Centre for Personalised Medicine, Institute of Translational Medicine, University of Liverpool, Liverpool, UK
  1. Correspondence to: T P van Staa Tjeerd.vanstaa{at}GPRD.com
  • Accepted 23 November 2011

What to prescribe for a patient in general practice when the choice of treatments has a limited evidence base? Tjeerd-Pieter van Staa and colleagues argue that using electronic health records to enter patients into randomised trials of treatments in real time could provide the answer

LARRY LIMNIDIS/IMAGEZOO/GETTY IMAGES/MONTAGE:ADC/BMJ

Ten years ago, in a paper called Britain’s Gift, the editor of the BMJ at the time and the director of the UK Cochrane Centre outlined a vision of medicine for the 21st century: easy access to good quality reviews of clinical evidence, and the streamlined recruitment of patients into randomised trials as a matter of routine whenever there is uncertainty about choice of treatment.

“For example,” they explained: “we still do not know which treatments are useful for acute stroke, but if every patient in the world experiencing a stroke were admitted to trials we would have enough patients within 24 hours to answer many of these questions.”1

The first goal of easy access to good quality reviews of evidence is on its way to being realised. Trials, however, remain exceptional in everyday clinical care, and sometimes address comparisons that are irrelevant to doctors and patients because they compare new treatments with placebo rather than with the best treatments currently available. Furthermore, trials are often conducted in idealised or unrepresentative patient groups.2 Because of these problems, randomised trials commonly fail to inform decisions in everyday clinical care: they address the abstract question of an intervention’s efficacy under ideal conditions, rather than its effectiveness when used in usual clinical practice, on outcomes that are important to patients.3 4

Here we describe a UK project to implement randomised trials as unobtrusively as possible in the everyday clinical work of general practitioners (GPs), comparing treatments that are already in common use, and using …

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