title: Randomised studies in general practice: how to integrate the electronic patient record.
abstract: The 'randomised database study' strategy was first proposed in 1997, with the aim of combining the generalisability of observational database studies based on electronic patient records (EPRs) with the validity of randomised clinical trials (RCTs). The key feature was to randomly assign treatments and to use routine care data, as available in the observational database, for patient identification and follow-up. To our knowledge, however, the idea of the randomised database study has not been implemented yet. The conduct of a randomised study in an observational database requires adjustments to methods of medical information processing in the general practice. We developed a software system that facilitates the conduct of an RCT with observational databases based on EPRs. It identifies eligible subjects and presents them one by one to the physician once their EPR is accessed. The general practitioner can then start an interactive recruitment process; after completion, the computer randomises the patients. Follow-up is documented by normal routine care in the EPR. Although the randomised database study has many methodological advantages, it has never been tested. Our software system is meant as a tool to implement and facilitate evaluation of the randomised database approach.
authors.affiliation: Department of Medical Informatics, ErasmusMC, University Medical Center, Rotterdam, The Netherlands.
authors.forename: Georgio
authors.initials: G
authors.lastname: Mosis
authors.forename: Bart
authors.initials: B
authors.lastname: Koes
authors.forename: Jeanne
authors.initials: J
authors.lastname: Dieleman
authors.forename: Bruno Ch
authors.initials: BCh
authors.lastname: Stricker
authors.forename: Johan
authors.initials: J
authors.lastname: van der Lei
authors.forename: Miriam C J M
authors.initials: MC
authors.lastname: Sturkenboom
mesh_terms: D003625:Data Collection / Q000706:statistics & numerical data; D019992:Databases as Topic / Q000458:organization & administration*; D005194:Family Practice; D006801:Humans; D008137:Longitudinal Studies; D008432:Mathematical Computing; D016347:Medical Records Systems, Computerized / Q000458:organization & administration*; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data; D009426:Netherlands; D009816:Office Automation; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D012985:Software Design