Prospective EHR-Based Clinical Trials: The Challenge of Missing Data
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This discussion focuses on the challenges of using prospectively collected electronic health record (EHR) data as outcomes in clinical trials, with a particular emphasis on the issue of missing data. Our discussion is motivated by the article in this issue: ‘Translating the Hemoglobin A1C with More Easily Understood Feedback: A Randomized Controlled Trial’ by Gopalan et al.1 In the spirit of open science, the authors generously shared their study protocol, statistical analysis plan and analysis data set. Using their data set, we conducted analyses to help emphasize important statistical issues. This editorial should not be considered a criticism of their paper; rather, their study is used as a reference to expand on the challenges of missing data in EHRs and to provide suggestions for future studies.
THE RISE OF EHR AND ITS USE IN CLINICAL TRIALS
The HITECH2act has empowered and incentivized healthcare providers to adopt EHRs. As a result, there has been a dramatic rise in EHR...
KeywordsAmerican Diabetes Association Electronic Health Record Health Information Exchange Electronic Health Record System Electronic Health Record Data
- 1.Gopalan A, Tahirovic E, Moss H, et al. Translating the hemoglobin A1C with more easily understood feedback: A Randomized Controlled Trial. J Gen Intern Med. 2014 doi: 10.1007/s11606-014-2810-4.
- 2.Health Information Technology for Economic and Clinical Health (HITECH) Act, Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (ARRA) Feb 17 2009.Google Scholar
- 3.Hsiao C, Hing E. Use and characteristics of Electronic Health Record systems among office-based physician practices: United States, 2001–2013. Centers for Disease Control and Prevention. 2014. http://www.cdc.gov/nchs/data/databriefs/db143.pdf. Accessed Jan 20, 2014.
- 5.Coombs CH. A Theory of Data. New York: John Wiley and Sons; 1964.Google Scholar
- 7.Wahls TL, Cram PM. The frequency of missed test results and associated treatment delays in a highly computerized health system. BMC Fam Pract. 2007;8(32):1–8.Google Scholar
- 9.Köpcke1 F, Trinczek B, Majeed RW, et al. Evaluation of data completeness in the electronic health record for the purpose of patient recruitment into clinical trials: A retrospective analysis of element presence. BMC Med Informat Decis Making. 2013;13(37).Google Scholar
- 11.Albu J, Sohler N, Matti-Orozco B, et al. Expansion of electronic health record-based screening, prevention, and management of diabetes in New York city. Preventable Chronic Diseases. 2013;10(E13).Google Scholar