title: Recommendations for the use of operational electronic health record data in comparative effectiveness research.
abstract: There is an increasing amount of clinical data in operational electronic health record (EHR) systems. Such data provide substantial opportunities for their re-use for many purposes, including comparative effectiveness research (CER). In a previous paper, we identified a number of caveats related to the use of such data, noting that they may be inaccurate, incomplete, transformed in ways that undermine their meaning, unrecoverable for research, of unknown provenance, of insufficient granularity, or incompatible with research protocols. In this paper, we provide recommendations for overcoming these caveats with the goal of leveraging such data to benefit CER and other health care activities. These recommendations include adaptation of "best evidence" approaches to use of data; processes to evaluate availability, completeness, quality, and transformability of data; creation of tools to manage data and their attributes; determination of metrics for assessing whether data are "research grade"; development of methods for comparative validation of data; construction of a methodology database for methods involving use of clinical data; standardized reporting methods for data and their attributes; appropriate use of informatics expertise; and a research agenda to determine biases inherent in operational data and to assess informatics approaches to their improvement.
authors.affiliation: Oregon Health & Science University.
authors.forename: William R
authors.initials: WR
authors.lastname: Hersh
authors.affiliation: National Institutes of Health Clinical Center.
authors.forename: James
authors.initials: J
authors.lastname: Cimino
authors.affiliation: The Ohio State University Wexner Medical Center.
authors.forename: Philip R O
authors.initials: PR
authors.lastname: Payne
authors.affiliation: The Ohio State University Wexner Medical Center.
authors.forename: Peter
authors.initials: P
authors.lastname: Embi
authors.affiliation: Oregon Health & Science University.
authors.forename: Judith
authors.initials: J
authors.lastname: Logan
authors.affiliation: AstraZeneca.
authors.forename: Mark
authors.initials: M
authors.lastname: Weiner
authors.affiliation: The University of Texas Health Science Center at Houston.
authors.forename: Elmer V
authors.initials: EV
authors.lastname: Bernstam
authors.affiliation: Johns Hopkins University.
authors.forename: Harold
authors.initials: H
authors.lastname: Lehmann
authors.affiliation: Columbia University.
authors.forename: George
authors.initials: G
authors.lastname: Hripcsak
authors.affiliation: Medical University of South Carolina.
authors.forename: Timothy
authors.initials: T
authors.lastname: Hartzog
authors.affiliation: Emory University.
authors.forename: Joel
authors.initials: J
authors.lastname: Saltz
keywords: data reuse; data use and quality; health information technology
references.citation: Health Serv Res. 2010 Oct;45(5 Pt 2):1523-40
references.pmid: 21054370
references.citation: Med Care. 2012 Jul;50 Suppl:S21-9
references.pmid: 22692254
references.citation: PLoS Comput Biol. 2012;8(12):e1002823
references.pmid: 23300414
references.citation: JAMA. 2013 Mar 13;309(10):991-2
references.pmid: 23483171
references.citation: Menopause. 2008 Jan-Feb;15(1):86-93
references.pmid: 17502840
references.citation: Acad Med. 2009 Jul;84(7):964-70
references.pmid: 19550198
references.citation: J Clin Epidemiol. 2007 Jul;60(7):686-95
references.pmid: 17573984
references.citation: Annu Rev Public Health. 2012 Apr;33:425-45
references.pmid: 22224891
references.citation: Pharmacoepidemiol Drug Saf. 2012 May;21 Suppl 2:44-52
references.pmid: 22552979
references.citation: Med Care. 2013 Aug;51(8 Suppl 3):S22-9
references.pmid: 23793049
references.citation: J Am Med Inform Assoc. 2011 Jan-Feb;18(1):99-103
references.pmid: 21106995
references.citation: BMJ. 2009 Jan 27;338:b81
references.pmid: 19174434
references.citation: J Am Med Inform Assoc. 2011 Mar-Apr;18(2):112-7
references.pmid: 21292706
references.citation: J Am Med Inform Assoc. 2013 Jan 1;20(1):144-51
references.pmid: 22733976
references.citation: Sci Transl Med. 2011 Jul 6;3(90):90cm17
references.pmid: 21734173
references.citation: J Am Med Inform Assoc. 2012 Jun;19(e1):e119-24
references.pmid: 22437072
references.citation: J Am Med Inform Assoc. 2007 Jan-Feb;14(1):1-9
references.pmid: 17077452
references.citation: Med Care. 2013 Aug;51(8 Suppl 3):S87-91
references.pmid: 23793052
references.citation: Pharmacoepidemiol Drug Saf. 2012 May;21 Suppl 2:29-36
references.pmid: 22552977
references.citation: J Biomed Discov Collab. 2011 Jun 06;6:48-52
references.pmid: 21647858
references.citation: BMC Med Genomics. 2011 Jan 26;4:13
references.pmid: 21269473
references.citation: N Engl J Med. 2010 Aug 5;363(6):501-4
references.pmid: 20647183
references.citation: Med Care. 2013 Aug;51(8 Suppl 3):S30-7
references.pmid: 23774517
references.citation: J Natl Cancer Inst Monogr. 2005;(35):12-25
references.pmid: 16287881
references.citation: J Am Med Inform Assoc. 2005 Sep-Oct;12(5):505-16
references.pmid: 15905487
references.citation: J Health Serv Res Policy. 2012 Jan;17(1):56-9
references.pmid: 21673116
references.citation: Stat Methods Med Res. 2013 Feb;22(1):70-96
references.pmid: 22016461
references.citation: J Am Med Inform Assoc. 2013 Jan 1;20(1):117-21
references.pmid: 22955496
references.citation: Ann Intern Med. 2007 Oct 16;147(8):573-7
references.pmid: 17938396
references.citation: J Biomed Inform. 2013 Oct;46(5):830-6
references.pmid: 23820016
references.citation: Diabetes Care. 2007 Sep;30(9):2287-92
references.pmid: 17519427
references.citation: Ann Intern Med. 2009 Sep 1;151(5):359-60
references.pmid: 19638404
references.citation: Pharmacoepidemiol Drug Saf. 2008 Jul;17(7):671-85
references.pmid: 18327852
references.citation: Fam Pract. 2006 Apr;23(2):253-63
references.pmid: 16368704
references.citation: J Biomed Inform. 2012 Aug;45(4):763-71
references.pmid: 22326800
references.citation: Cancer J. 2011 Jul-Aug;17(4):235-8
references.pmid: 21799331
references.citation: Ann Intern Med. 2010 Jun 1;152(11):726-32
references.pmid: 20335313
references.citation: Med Care. 2010 Jun;48(6 Suppl):S17-22
references.pmid: 20421825
references.citation: J Am Med Inform Assoc. 2013 Dec;20(e2):e311-8
references.pmid: 23975625