@article{43c29e200fe443c7a687d847c9a86be0,
title = "Challenges in Using Real-world Clinical Practice Records for Validation of Clinical Trial Data in Inflammatory Bowel Disease: Lessons Learned",
abstract = "Electronic medical records (EMRs) have gained widespread use in clinical practice and by default serve as a large patient database with potential for use in clinical research. Although there remains significant interest in leveraging EMRs for research purposes, extraction of data has proven to be complex and with insufficient accuracy. We describe the limitations of an EMR in our attempt to conduct a seemingly simple study aimed at validating variables identified in the PRECiSE 3, a 7-year open label safety and efficacy study of certolizumab pegol in Crohn's disease that identified clinical factors that predicted both short- and long-term efficacy. A multicenter, retrospective cohort study from 8 academic and large community practices was performed, and data were collected from each respective EMR. Significant challenges with reliable capture of key data elements were encountered, and overall a screen fail rate of 91.8% across all sites was seen. We describe these challenges and potential future directions to work together to advance accuracy and implementation of the use of EMRs in inflammatory bowel disease.",
keywords = "Crohn's disease, big data clinical trials, clinical trials, electronic medical records, inflammatory bowel disease",
author = "Anita Afzali and Ciorba, {Matthew A.} and Schwartz, {David A.} and Mai Sharaf and Chris Fourment and Timothy Ritter and Wolf, {Douglas C.} and Ira Shafran and Randall, {Charles W.} and Kane, {Sunanda V.}",
note = "Funding Information: Conflicts of interest: A.A.: consultant to AbbVie, Takeda, UCB; research support from UCB; speaker bureau UCB; board member and consultant for IBD Horizons. M.C.: consultant to Pfizer, Takeda, Theravance; research support from Gilead, Pfizer, UCB; speakers{\textquoteright} bureau AbbVie, Takeda, UCB. D.S.: consultant to AbbVie, Janssen, Takeda, Tigenix, UCB; grant support from AbbVie, UCB. M.S.: none. C.F.: consultant for Takeda, and Janssen; speaker for UCB. T.R.: speaker for Takeda and Janssen; advisory boards for Pfizer, Takeda, Janssen, and UCB. D.W.: none. I.S.: research funding from UCB. C.R.: consultant to Janssen, Takeda, Synergy, and UCB; research support from Amgen BMS Celgene Gilead, Luitpold, Pfizer, Roche, Salix, Shire, UCB; speakers{\textquoteright} bureau: Janssen, Salix. S.K.: research support from UCB; consultant to AbbVie, Janssen, Merck, Spherix Health, 11 Health, UCB; board member GI Specialty Board for ABIM. Publisher Copyright: {\textcopyright} 2017 Crohn's & Colitis Foundation. Published by Oxford University Press. All rights reserved.",
year = "2018",
month = jan,
day = "1",
doi = "10.1093/ibd/izx015",
language = "English",
volume = "24",
pages = "2--4",
journal = "Inflammatory bowel diseases",
issn = "1078-0998",
number = "1",
}