A pragmatic method for electronic medical record-based observational studies: Developing an electronic medical records retrieval system for clinical research

BMJ Open

Volumn 2, Issue 6, 2012, Pages

  Yamamoto, Keiichi ^a   Sumi, Eriko ^a   Yamazaki, Toru ^b   Asai, Keita ^b   Yamori, Masashi ^b   Teramukai, Satoshi ^a   Bessho, Kazuhisa ^b   Yokode, Masayuki ^a   Fukushima, Masanori ^c  

^a KYOTO UNIVERSITY HOSPITAL   (Japan)

^b KYOTO UNIVERSITY   (Japan)

^c FOUNDATION FOR BIOMEDICAL RESEARCH AND INNOVATION   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL RESEARCH; DATA PROCESSING; ELECTRONIC MEDICAL RECORD; INFORMATION RETRIEVAL; MEDICAL INFORMATION SYSTEM; OBSERVATIONAL STUDY; PATIENT IDENTIFICATION;

EID: 84871082731     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2012-001622     Document Type: Article

References (58)

1. Embi PJ, Payne PR. Clinical research informatics: challenges, opportunities and definition for an emerging domain. J Am Med Inform Assoc 2009;16:316-27.
2. Prokosch HU, Ganslandt T. Perspectives for medical informatics. Reusing the electronic medical record for clinical research. Methods Inf Med 2009;48:38-44.
3. Wasserman RC. Electronic medical records (EMRs), epidemiology, and epistemology: reflections on EMRs and future pediatric clinical research. Acad Pediatr 2011;11:280-7.
4. Dean BB, Lam J, Natoli JL, et al. Review: use of electronic medical records for health outcomes research: a literature review. Med Care Res Rev 2009;66:611-38.
5. Tannen RL, Weiner MG, Marcus SM. Simulation of the Syst-Eur randomized control trial using a primary care electronic medical record was feasible. J Clin Epidemiol 2006;59:25464.
6. Williams JG, Cheung WY, Cohen DR. Can randomised trials rely on existing electronic data? A feasibility study to explore the value of routine data in health technology assessment. Health Technol Assess 2003;7: iii, v-x, 1-117.
7. Yamamoto K, Matsumoto S, Tada H, et al. A data capture system for outcomes studies that integrates with electronic health records: development and potential uses. J Med Syst 2008;32:423-7.
8. Yamamoto K, Matsumoto S, Yanagihara K, et al. A data-capture system for post-marketing surveillance of drugs that integrates with hospital electronic health records. Open Access J Clin Trials 2011;3:21-6.
9. Embi PJ, Jain A, Clark J, et al. Effect of a clinical trial alert system on physician participation in trial recruitment. Arch Intern Med 2005;165:2272-7. (Pubitemid 41549924)
10. Campbell MK, Snowdon C, Francis D, et al. Recruitment to randomised trials: strategies for trial enrollment and participation study. The STEPS study. Health Technol Assess 2007;11:iii, ix-105.
11. Dugas M, Lange M, Müller-Tidow C, et al. Routine data from hospital information systems can support patient recruitment for clinical studies. Clin Trials 2010;7:183-9.
12. Thadani SR, Weng C, Bigger JT, et al. Electronic screening improves efficiency in clinical trial recruitment. J Am Med Inform Assoc 2009;16:869-73.
13. Torgerson JS, Arlinger K, Käppi M, et al . Principles for enhanced recruitment of subjects in a large clinical trial: the XENDOS study experience. Control Clin Trials 2001;22:515-25. (Pubitemid 32907435)
14. Kristianson KJ, Ljunggren H, Gustafsson LL. Data extraction from a semi-structured electronic medical record system for outpatients: a model to facilitate the access and use of data for quality control and research. Health Inform J 2009;15:305-19.
15. Shim JP. Past, present, and future of decision support technology. Decis Support Syst 2002;33:111-26. (Pubitemid 34222527)
16. Prat N. A UML-based data warehouse design method. Decis Support Syst 2006;42:1449-73. (Pubitemid 44648435)
17. Park YT. An empirical investigation of the effects of data warehousing on decision performance. Inform Manag 2006;43:51.
18. Schlaps D, Schmid T. Data warehousing in clinical research and development - from clinical data to knowledge portals. Pharmind 2004;66:637-46. (Pubitemid 38842986)
19. Grant A, Moshyk A, Diab H, et al. Integrating feedback from a clinical data warehouse into practice organisation. Int J Med Inform 2006;75:232-9.
20. Junttila K, Meretoja R, Seppälä A, et al. Data warehouse approach to nursing management. J Nurs Manag 2007;15:155-61.
21. Rubin DL, Desser TS. A data warehouse for integrating radiologic and pathologic data. J Am Coll Radiol 2008;5:210-17. (Pubitemid 351296011)
22. Johnson SB. Generic data modeling for clinical repositories. J Am Med Inform Assoc 1996;3:328-39. (Pubitemid 126445035)
23. Nadkarni PM, Brandt C. Data extraction and ad hoc query of an entity - attribute - value database. J Am Med Inform Assoc 1998;5:511-27. (Pubitemid 28520940)
24. Anhøj J. Generic design of web-based clinical databases. J Med Internet Res 2003;5:e27.
25. Chen RS, Nadkarni P, Marenco L, et al. Exploring performance issues for a clinical database organized using an entity-attribute-value representation. J Am Med Inform Assoc 2000;7:475-87. (Pubitemid 32410031)
26. Dinu V, Nadkarni P. Guidelines for the effective use of entity-attribute-value modeling for biomedical databases. Int J Med Inform 2007;76:769-79. (Pubitemid 47575947)
27. Corwin J, Silberschatz A, Miller PL, et al. Dynamic tables: an architecture for managing evolving, heterogeneous biomedical data in relational database management systems. J Am Med Inform Assoc 2007;14:86-93. (Pubitemid 44909480)
28. Wade TD, Hum RC, Murphy JR. A dimensional bus model for integrating clinical and research data. J Am Med Inform Assoc 2011;1:96-102.
29. Pardillo J, Mazón JN. Model-driven development of OLAP metadata for relational data warehouses. Comput Stand Interfac 2012;34:189-202.
30. Hettler M. Data mining goes multidimensional. Healthc Inform 1997;14:43-6, 48, 51-6.
31. Gordon BD, Asplin BR. Using online analytical processing to manage emergency department operations. Acad Emerg Med 2004;11:1206-12. (Pubitemid 39451794)
32. Kimball R, Reeves L, Ross M, et al. The data warehouse lifecycle toolkit. New York: John Wiley, 1998.
33. Wang D, Peleg M, Tu SW, et al. Representation primitives, process models and patient data in computer-interpretable clinical practice guidelines: a literature review of guideline representation models. Int J Med Inform 2002;68:18.
34. Weng C, Tu SW, Sim I, et al. Formal representation of eligibility criteria: a literature review. J Biomed Inform 2010;43:451-67.
35. Lonsdale DW, Tustison C, Parker CG, et al. Assessing clinical trial eligibility with logic expression queries. Data Knowl Eng 2008;66:3-17. (Pubitemid 351749493)
36. Tu SW, Peleg M, Carini S, et al. A practical method for transforming free-text eligibility criteria into computable criteria. J Biomed Inform 2011;44:239-50.
37. Sordo M, Boxwala AA, Ogunyemi O, et al. Description and status update on GELLO: a proposed standardized object-oriented expression language for clinical decision support. Stud Health Technol Inform 2004;107:164-8.
38. Séroussi B, Bouaud J. Using OncoDoc as a computer-based eligibility screening system to improve accrual onto breast cancer clinical trials. Artif Intell Med 2003;29:153-67. (Pubitemid 37074854)
39. CDISC ASPIRE: Integration of clinical research and EHR: Eligibility coding standards. http://crisummit2010.amia.org/files/symposium2008/S14-Niland. pdf (accessed 26 Oct 2012).
40. CDISC Study Design Model: SDM-XML Version 1.0. http://www.cdisc.org/ stuff/contentmgr/files/0/8c85b168e80d6834ded59339b55fdbc7/misc/cdisc-sdm-xml-1. 0.pdf (accessed 26 Oct 2012).
41. US National Cancer Institute (NCI). caMATCH. https://cabig.nci.nih.gov/ community/tools/caMATCH (accessed 31 Mar 2012).
42. Jagannathan V, Mullett CJ, Arbogast JG, et al. Assessment of commercial NLP engines for medication information extraction from dictated clinical notes. Int J Med Inform 2009;78:284-91.
43. Pakhomov S, Weston SA, Jacobsen SJ, et al. Electronic medical records for clinical research: application to the identification of heart failure. Am J Manag Care 2007;13:281-8. (Pubitemid 46983137)
44. Yamamoto K, Yamanaka K, Hatano E, et al. An eClinical trial system for cancer that integrates with clinical pathways and electronic medical records. Clin Trials 2012;9:408-17.
45. Matsumura Y, Kuwata S, Yamamoto Y, et al. Template-based data entry for general description in medical records and data transfer to data warehouse for analysis. Stud Health Technol Inform 2007;129(PT 1):412-16.
46. World Health Organization (WHO). International Classification of Diseases (ICD). http://www.who.int/classifications/icd/en/ (accessed 26 Oct 2012).
47. Yamazaki T, Yamori M, Yamamoto K, et al. Risk of osteomyelitis of the jaw induced by oral bisphosphonates in patients taking medications for osteoporosis: a hospital-based cohort study in Japan. Bone 2012;51:882-7.
48. Fellows JL, Rindal DB, Barasch A, et al. ONJ in two dental practice-based research network regions. J Dent Res 2011;90:433-8.
49. Vestergaard P, Schwartz K, Rejnmark L, et al. Oral bisphosphonate use increases the risk for inflammatory jaw disease: a cohort study. J Oral Maxillofac Surg 2012;70:821-9.
50. Shortliffe EH, Cimino JJ. Biomedical informatics: computer applications in health care and biomedicine. Health Informatics series. New York: Springer, 2006.
51. McFadden E. Management of data in clinical trials. 2nd edn, Hoboken, NJ: Wiley-Interscience, 2007.
52. Zhengwu L, Jing S. Clinical data management: current status, challenges, and future directions from industry perspectives. Open Access J Clin Trials 2010;2:93-105.
53. Data Management Association (DAMA) International. Data management body of knowledge. http://www.dama.org/i4a/pages/index.cfm?pageid=3364 (accessed 26 Oct 2012).
54. MedDRA MSSO. MedDRA MSSO. http://www.meddramsso.com/ (accessed 31 Mar 2012).
55. US National Library of Medicine. SNOMED clinical terms, http://www.nlm.nih.gov/research/umls/Snomed/snomed-main.html (accessed 31 Mar 2012).
56. Clinical Data Interchange Standards Consortium (CDISC). Study data tabulation model (SDTM). http://www.cdisc.org/sdtm (accessed 26 Oct 2012).
57. Huff S. Development of the logical observation identifier names and codes (LOINC) vocabulary. J Am Med Inform Assoc 1998;5:276-92. (Pubitemid 28222035)
58. Health level seven (HL7). http://www.hl7.com/ (accessed 26 Oct 2012).