Use of electronic healthcare records in large‐scale simple randomized trials at the point of care for the documentation of value‐based medicine

A solid foundation of evidence of the effects of an intervention is a prerequisite of evidence‐based medicine. The best source of such evidence is considered to be randomized trials, which are able to avoid confounding. However, they may not always estimate effectiveness in clinical practice. Databases that collate anonymized electronic health records (EHRs) from different clinical centres have been widely used for many years in observational studies. Randomized point‐of‐care trials have been initiated recently to recruit and follow patients using the data from EHR databases. In this review, we describe how EHR databases can be used for conducting large‐scale simple trials and discuss the advantages and disadvantages of their use.

[1]  J. Brady,et al.  The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research. , 2015, The Journal of the American College of Dentists.

[2]  R. Hubbard,et al.  Variability of antibiotic prescribing in patients with chronic obstructive pulmonary disease exacerbations: a cohort study , 2013, BMC Pulmonary Medicine.

[3]  J. Ioannidis Mega-trials for blockbusters. , 2013, JAMA.

[4]  S. Cummings,et al.  Improving the efficiency and effectiveness of pragmatic clinical trials in older adults in the United States. , 2012, Contemporary clinical trials.

[5]  J. Casas,et al.  Statins for all by the age of 50 years? , 2012, The Lancet.

[6]  R. Collins,et al.  The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. , 2012, Lancet.

[7]  R. Collins,et al.  The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials , 2012, The Lancet.

[8]  H. Eichler,et al.  Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval , 2012, Clinical pharmacology and therapeutics.

[9]  L. Smeeth,et al.  Pragmatic randomised trials using routine electronic health records: putting them to the test , 2012, BMJ : British Medical Journal.

[10]  T. V. van Staa,et al.  Recent advances in the utility and use of the General Practice Research Database as an example of a UK Primary Care Data resource , 2012, Therapeutic advances in drug safety.

[11]  R. Herings,et al.  Pharmacy-Based Medical Record Linkage Systems , 2012 .

[12]  L. Smeeth,et al.  Randomised Evaluations of Accepted Choices in Treatment (REACT) trials: large-scale pragmatic trials within databases of routinely collected electronic healthcare records , 2011, Trials.

[13]  I. Boutron,et al.  Blinding in Randomized Clinical Trials: Imposed Impartiality , 2011, Clinical pharmacology and therapeutics.

[14]  L. Yardley,et al.  Cluster randomised trial in the General Practice Research Database: 1. Electronic decision support to reduce antibiotic prescribing in primary care (eCRT study) , 2011, Trials.

[15]  R. Rodríguez-Roisín,et al.  WITHDRAWN: Antibiotics for exacerbations of chronic obstructive pulmonary disease. , 2011, The Cochrane database of systematic reviews.

[16]  R. Rodríguez-Roisín,et al.  Antibiotics for exacerbations of chronic obstructive pulmonary disease. , 2011, The Cochrane database of systematic reviews.

[17]  E. Glader,et al.  Persistent Use of Secondary Preventive Drugs Declines Rapidly During the First 2 Years After Stroke , 2010, Stroke.

[18]  H. Sørensen,et al.  The Nordic countries as a cohort for pharmacoepidemiological research. , 2010, Basic & clinical pharmacology & toxicology.

[19]  L. Smeeth,et al.  A Comparison of Cost Effectiveness Using Data from Randomized Trials or Actual Clinical Practice: Selective Cox-2 Inhibitors as an Example , 2009, PLoS medicine.

[20]  R. Califf,et al.  Scientific evidence underlying the ACC/AHA clinical practice guidelines. , 2009, JAMA.

[21]  A. de Boer,et al.  Long term persistence with statin treatment in daily medical practice , 2004, Heart.

[22]  Richard Birtwhistle,et al.  Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity. , 2003, BMC medical research methodology.

[23]  B. Psaty,et al.  Is Drug Treatment of Hypertension in Clinical Practice as Effective as in Randomized Controlled Trials with Regard to the Reduction of the Incidence of Stroke? , 2001, Epidemiology.

[24]  R Day,et al.  Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. , 2000, The New England journal of medicine.

[25]  R. Makuch,et al.  Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: A randomized controlled trial. Celecoxib Long-term Arthritis Safety Study. , 2000, JAMA.

[26]  J. Lellouch,et al.  Explanatory and pragmatic attitudes in therapeutical trials. , 1967, Journal of chronic diseases.

[27]  B. Giraudeau,et al.  [Cluster randomised trials]. , 2014, Annales de dermatologie et de venereologie.

[28]  Cholesterol Treatment Trialists' Collaborato The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials , 2012 .

[29]  Leonard W. D'Avolio,et al.  A point-of-care clinical trial comparing insulin administered using a sliding scale versus a weight-based regimen. , 2011, Clinical trials.

[30]  J. McGinnis,et al.  Evidence-based medicine - engineering the Learning Healthcare System. , 2010, Studies in health technology and informatics.

[31]  Lise,et al.  Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. , 2000, The New England journal of medicine.