A randomized database study in general practice yielded quality data but patient recruitment in routine consultation was not practical

Journal of Clinical Epidemiology
Georgio MosisMiriam C J M Sturkenboom

Abstract

To assess patient recruitment and quality of data in a randomized database study. A randomized database study was conducted in the Integrated Primary Care Information (IPCI) general practice research database. Software was built to allow for automated patient identification and recruitment, and randomization. As an application, we compared gastrointestinal tolerability in persons treated with diclofenac and celecoxib for osteoarthritis. The outcomes were assessed in the IPCI database. To assess accuracy of exposure and outcome, we also collected information by self-administrated patient questionnaires. For all eligible subjects, we assessed the main reason for noninclusion. Physicians were interviewed to evaluate the study and to identify the major obstacles. Forty-two general practice physicians collaborated with the study and 7,127 potential study subjects were identified. Among these subjects, 170 were eligible for recruitment and 20 (11.8%) were randomized. Of the eligible patients, 96 (56.5%) were not recruited because the physician was too busy or the patient was treated by another healthcare provider and 54 (31.8%) were not recruited because of exclusion criteria. Concordance between questionnaires and IPCI data and the ...Continue Reading

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Citations

Jul 6, 2014·Journal of Medical Internet Research·Felix Köpcke, Hans-Ulrich Prokosch
May 1, 2012·Journal of the American Medical Informatics Association : JAMIA·Chunhua WengJ Thomas Bigger
Sep 22, 2007·Journal of Clinical Epidemiology·Stephen D BrealeyClare Wilkinson
Jun 2, 2016·The New England Journal of Medicine·Louis D Fiore, Philip W Lavori
Sep 14, 2017·European Journal of Clinical Pharmacology·Rafael Dal-RéXavier Carné
Mar 27, 2010·Clinical Trials : Journal of the Society for Clinical Trials·Martin DugasHans-Ulrich Prokosch
Nov 26, 2009·Clinical Trials : Journal of the Society for Clinical Trials·Paul C SchroyJohn B Wong
Mar 29, 2019·BMJ : British Medical Journal·Rafael Dal-RéShaun Treweek
Feb 20, 2020·Expert Review of Clinical Pharmacology·Rafael Dal-Ré
Sep 2, 2011·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Robert F ReynoldsSybil M Eng

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