Electronic clinical laboratory test results data tables: Lessons from Mini-Sentinel

Pharmacoepidemiology and Drug Safety

Volumn 23, Issue 6, 2014, Pages 609-618

  Raebel, Marsha A ^a,b   Haynes, Kevin ^c   Woodworth, Tiffany S ^d   Saylor, Gwyn ^e   Cavagnaro, Elizabeth ^d   Coughlin, Kara O ^d   Curtis, Lesley H ^f   Weiner, Mark G ^g,i   Archdeacon, Patrick ^h   Brown, Jeffrey S ^d  

^a KAISER PERMANENTE   (United States)

^b UNIVERSITY OF COLORADO   (United States)

^c UNIVERSITY OF PENNSYLVANIA   (United States)

^d HARVARD MEDICAL SCHOOL   (United States)

^e CENTER FOR HEALTH RESEARCH   (United States)

^f DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^g TEMPLE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^h CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

ⁱ UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

Administrative database; Clinical database; Distributed data network; Electronic laboratory databases; Laboratory test results; Pharmacoepidemiology; Post marketing evaluation; Safety surveillance

Indexed keywords

CREATININE; GLUCOSE; HEMOGLOBIN A1C;

ARTICLE; BLOOD CHEMISTRY; CLINICAL LABORATORY; CLINICAL STUDY; CREATININE BLOOD LEVEL; ELECTRONIC MEDICAL RECORD; HEALTH CARE DELIVERY; HEALTH INSURANCE; HUMAN; INTERNATIONAL NORMALIZED RATIO; LABORATORY RESULTS TABLE; LABORATORY TEST; LIVER FUNCTION; LIVER INJURY; LOGICAL OBSERVATION IDENTIFIERS NAMES AND CODES; PHARMACOEPIDEMIOLOGY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; SENTINEL SURVEILLANCE; URINALYSIS; FACTUAL DATABASE; HOSPITAL INFORMATION SYSTEM; PILOT STUDY; STANDARDS; TRENDS;

CLINICAL LABORATORY INFORMATION SYSTEMS; DATABASES, FACTUAL; ELECTRONIC HEALTH RECORDS; HUMANS; PILOT PROJECTS; SENTINEL SURVEILLANCE;

EID: 84901842025     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3580     Document Type: Article

References (22)

1. Curtis LH, Weiner MG, Boudreau DM, et al. Design considerations, architecture, and use of the Mini-Sentinel distributed data system. Pharmacoepidemiol Drug Saf 2012; 21(Suppl 1): 23-31. DOI:10.1002/pds.2336.
2. Maro JC, Platt R, Holmes JH, et al. Design of a national distributed health data network. Ann Intern Med 2009; 151: 341-344.
3. Brown JS, Holmes JH, Shah K, Hall K, Lazarus R, Platt R. Distributed health data networks: a practical and preferred approach to multi-institutional evaluations of comparative effectiveness, safety, and quality of care. Med Care 2010; 48: S45-S51. DOI:10.1097/MLR.0b013e3181d9919f.
4. Toh S, Platt R, Steiner JF, Brown JS. Comparative-effectiveness research in distributed health data networks. Clin Pharmacol Ther 2011; 90: 883-887. DOI:10.1038/clpt.2011.236.
5. Behrman RE, Benner JS, Brown JS, McClellan M, Woodcock J, Platt R. Developing the Sentinel System - a national resource for evidence development. N Engl J Med 2011; 364: 498-499. DOI:10.1056/NEJMp1014427.
6. Platt R, Carnahan RM, Brown JS, et al. The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction. Pharmacoepidemiol Drug Saf 2012; 21(Suppl 1): 1-8. DOI:10.1002/pds.2343.
7. Hornbrook MC, Hart G, Ellis JL, et al. Building a virtual cancer research organization. J Natl Cancer Inst Monogr 2005; 35: 12-25.
8. Andrade SE, Raebel MA, Boudreau D, et al. Automated data systems: health maintenance organizations/health plans. In Pharmacoepidemiology (5th edn), Strom BL, Kimmel SE, Hennessy S (eds.). Wiley-Blackwell: Chichester, West Sussex, 2012; 163-188.
9. Kahn MG, Raebel MA, Glanz JM, Riedlinger K, Steiner JF. A pragmatic framework for single-site and multisite data quality assessment in electronic health record-based clinical research. Med Care 2012; 50: S21-S29. DOI: kahn 10.1097/MLR.0b013e318257dd67
10. Nichols GA, Desai J, Elston LJ, et al. Construction of a multisite DataLink using electronic health records for the identification, surveillance, prevention, and management of diabetes mellitus: the SUPREME-DM project. Prev Chronic Dis 2012; 9: E110 Epub 2012 Jun 7.
11. Schneeweiss S, Rassen JA, Glynn RJ, et al. Supplementing claims data with outpatient laboratory test results to improve confounding adjustment in effectiveness studies of lipid-lowering treatments. BMC Med Res Methodol 2012; 12: 180. doi:10.1186/1471-2288-12-180.
12. Nag SS, Daniel GW, Bullano MF, et al. LDL-C goal attainment among patients newly diagnosed with coronary heart disease or diabetes in a commercial HMO. J Manag Care Pharm 2007; 13: 652-663.
13. American Medical Association. CPT - Current Procedural Terminology. Available at: http://www.ama-assn.org/ama/pub/physician-resources/solutions-managing-your-practice/coding-billing-insurance/cpt page [serial online] 2013; [3 July 2013].
14. ®). Available at: http://loinc.org/ [serial online] 2013; [3 July 2013].
15. McDonald CJ, Huff SM, Suico JG, et al. LOINC, a universal standard for identifying laboratory observations: a 5-year update. Clin Chem 2003; 49: 624-633.
16. Huff SM, Rocha RA, McDonald CJ, et al. Development of the Logical Observation Identifier Names and Codes (LOINC) vocabulary. J Am Med Inform Assoc 1998; 5: 276-292.
17. Khan AN, Griffith SP, Moore C, Russell D, Rosario AC, Jr., Bertolli J. Standardizing laboratory data by mapping to LOINC. J Am Med Inform Assoc 2006; 13: 353-355.
18. Sujansky WV, Overhage JM, Chang S, Frohlich J, Faus SA. The development of a highly constrained health level 7 implementation guide to facilitate electronic laboratory reporting to ambulatory electronic health record systems. J Am Med Inform Assoc 2009; 16: 285-290. DOI:10.1197/jamia.M2610.
19. Brown JS, Kahn M, Toh S. Data quality assessment for comparative effectiveness research in distributed data networks. Med Care 2013; 51: S22-S29. DOI:10.1097/MLR.0b013e31829b1e2c.
20. Rosati K, Evans B, McGraw D. HIPAA and common rule compliance in the Mini-Sentinel pilot, white paper. Available at: http://mini-sentine.lorg/work_products/About_Us/HIPAA_and_CommonRuleCompliance_in_the_Mini-SentinelPilot.pdf. [serial online] 2011; [19 August 2013].
21. Department of Health and Human Services, Office of the Secretary. Standards for privacy of individually identifiable health information; final rule. 45 CFR Parts 160 and 164. Available at: http://www.ihs.gov/privacyact/documents/privrulepd.pdf [serial online] 2002;Federal Register:53182-53273.
22. Mini-Sentinel. Modular Programs. Available at: http://mini-sentinel.org/data_activities/modular_programs/default.aspx. [serial online] 2013; [17 August 2013].