title: Use of electronic healthcare records in large-scale simple randomized trials at the point of care for the documentation of value-based medicine.
abstract: 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.
authors.affiliation: Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands; London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: T-P
authors.initials: TP
authors.lastname: van Staa
authors.forename: O
authors.initials: O
authors.lastname: Klungel
authors.forename: L
authors.initials: L
authors.lastname: Smeeth
mesh_terms: D015986:Confounding Factors, Epidemiologic; D004282:Documentation / Q000379:methods / Q000592:standards; D057286:Electronic Health Records / Q000458:organization & administration*; D019317:Evidence-Based Medicine / Q000379:methods*; D006801:Humans; D020380:Needs Assessment; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards; D012107:Research Design
keywords: clinical trials; epidemiology