Evolution of Human Factors Research and Studies of Health Information Technologies: The Role of Patient Safety

M.C. Beuscart-Zéphir; E. Borycki; P. Carayon; M.W.M. Jaspers; S. Pelayo

doi:10.1055/s-0038-1638835

Yearbook of Medical Informatics, Table of Contents

Yearb Med Inform 2013; 22(01): 67-77
DOI: 10.1055/s-0038-1638835

Original Article

Georg Thieme Verlag KG Stuttgart

Evolution of Human Factors Research and Studies of Health Information Technologies: The Role of Patient Safety

M.C. Beuscart-Zéphir

¹INSERM CIC-IT/Evalab, Lille; CHU Lille; Université Lille Nord de France, UDSL EA 2694; Lille, France

,

E. Borycki

²School of Health Information Science, University of Victoria, Victoria, British Columbia, Canada

,

P. Carayon

³Department of Industrial and Systems Engineering, Center for Quality and Productivity Improvement, University of Wisconsin-Madison, Madison, Wisconsin, USA

,

M.W.M. Jaspers

⁴Center of Human Factors Engineering of Health Information Technology, Department of Medical Informatics, Academic Medical Center, University of Amsterdam, The Netherlands

,

S. Pelayo

¹INSERM CIC-IT/Evalab, Lille; CHU Lille; Université Lille Nord de France, UDSL EA 2694; Lille, France

› Author Affiliations

Abstract

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Keywords

Human engineering - usability - patient safety - regulation - medical informatics applications

References

References
1 Beuscart-Zephir MC, Elkin P, Pelayo S, Beuscart R. The human factors engineering approach to biomedical informatics projects: state of the art, results, benefits and challenges. Yearb Med Inform 2007; 109-27.
2 Beuscart-Zephir MC, Pelayo S, Borycki E, Kushniruk A. Human Factors Considerations in Health IT Design and Development. In: Carayon P. editor. Human Factors and Ergonomics in Health Care and Patient Safety 2nd Edition. CRC Press; 2012. p. 649-70.
3 To Err Is Human: Building a Safer Health System. The National Academies Press; 2000
4 Blumenthal D, Tavenner M. The “meaningful use” regulation for electronic health records. N Engl J Med 2010; Aug 5 363 (6) 501-4.
5 Meaningful Use. Health IT gov. 2013 [cited 2013 Jan 12] Available from: URL: http://www.healthit.gov/policy-researchers-implementers/meaningful-use
6 Stringer J, Sinkala M, Fuller J. US-Zambian Collaboration Receives $4 Million To Establish Electronic Obstetric And Newborn Medical Record. In Lusaka, Zambia: Gates Foundation; 2001. July 11 [cited 2013 Jan 12] Available from: URL: http://www.gatesfoundation.org
7 Borycki E, Kushniruk A. Where do technology-induced errors come from? Towards a model for conceptuallizing and diagnosing errors caused by technology. In: Kushniruk A, Borycki E. editors. Human, Social and Organizational Aspects of Health Information Systems. Hershey, NY: Idea Group; 2008
8 Wetterneck TB, Walker JM, Blosky MA, Cartmill RS, Hoonakker P, Johnson MA. et al. Factors contributing to an increase in duplicate medication order errors after CPOE implementation. J Am Med Inform Assoc 2011; Nov 18 (6) 774-82.
9 Directive 2007/47/EC of the European Parliament and of the Council. Official Journal of the European Union. 2007 September 5 [cited 2013 Jan 12] Available from: URL: http://eur-lex.europa.eu/
10 Borycki E, Kushniruk A. Identifying and preventing technology-induced error using simulations: application of usability engineering techniques. Healthc Q 2005; 8 Spec No 99-105.
11 Kushniruk AW, Triola MM, Borycki EM, Stein B, Kannry JL. Technology induced error and usability: the relationship between usability problems and prescription errors when using a handheld application. Int J Med Inform 2005; Aug 74 (7- 8) 519-26.
12 Karsh BT, Weinger MB, Abbott PA, Wears RL. Health information technology: fallacies and sober realities. J Am Med Inform Assoc 2010; Nov 17 (6) 617-23.
13 International Ergonomics Association. Definition of Ergonomics. International Ergonomics Association. 2012 February 20 [cited 2013 Jan 12] Available from: URL: http://www.iea.cc/
14 International Organization for Standardization. Ergonomics of human-system interaction — Part 210: Human-centred design for interactive systems. Geneva: International Organization for Standardization; 2010
15 Horsky J, Kuperman GJ, Patel VL. Comprehensive analysis of a medication dosing error related to CPOE. J Am Med Inform Assoc 2005; Jul 12 (4) 377-82.
16 Patel VL, Currie LM. Health IT Patient Safety Action and Surveillance Plan. Int J Med Inform 2005; Dec 74 (11-12) 869-85.
17 Carayon P, Hundt AS. Work system design for patient safety: The SEIPS model. Quality and Safety in Health Care 2006; 15 (Supplement I) i50-i58.
18 Ammenwerth E, Schnell-Inderst P, Machan C. Siebert U. The effect of electronic prescribing on medication errors and adverse drug events: a systematic review. J Am Med Inform Assoc 2008; Sep 15 (5) 585-600.
19 International Electrotechnical Commission. Application of usability engineering to medical devices. Geneva: International Electrotechnical Commission; 2007. Report No.: IEC 62366.
20 International Electrotechnical Commission. Medical Electrical Equipment — General requirements for basic safety and essential performance. Collateral Standard. Usability. Geneva: International Electrotechnical Commission; 2007. Report No.: IEC 60601-1-6).
21 International Electrotechnical Commission. Medical Electrical Equipment — General requirements for basic safety and essential performance. Collateral Standard. Usability. Geneva: International Electrotechnical Commission; 2010. Report No.: EC 60601-1-6.
22 Walker JM, Carayon P, Leveson N, Paulus RA, Tooker J, Chin H. et al. EHR safety: the way forward to safe and effective systems. J Am Med Inform Assoc 2008; May 15 (3) 272-7.
23 Borycki EM, Househ MS, Kushniruk AW, Nohr C, Takeda H. Empowering Patients: Making Health Information and Systems Safer for Patients and the Public. Contribution of the IMIA Health Informatics for Patient Safety Working Group. Yearb Med Inform 2012; 7 (1) 56-64.
24 Kushniruk A, Borycki E, Kuwata S, Kannry J. Predicting changes in workflow resulting from healthcare information systems: ensuring the safety of healthcare. Healthc Q 2006; Oct 9 Spec No 114-8.
25 Peute LW, Jaspers MW. The significance of a usability evaluation of an emerging laboratory order entry system. Int J Med Inform 2007; Feb 76 (2- 3) 157-68.
26 Khajouei R, Peek N, Wierenga PC, Kersten MJ, Jaspers MW. Effect of predefined order sets and usability problems on efficiency of computerized medication ordering. Int J Med Inform 2010; Oct 79 (10) 690-8.
27 Magrabi F, Ong MS, Runciman W, Coiera E. An analysis of computer-related patient safety incidents to inform the development of a classification. J Am Med Inform Assoc 2010; Nov 17 (6) 663-70.
28 Magrabi F, Ong MS, Runciman W, Coiera E. Using FDA reports to inform a classification for health information technology safety problems. J Am Med Inform Assoc 2012; Jan 19 (1) 45-53.
29 Campbell EM, Sittig DF, Ash JS, Guappone KP, Dykstra RH. Types of unintended consequences related to computerized provider order entry. J Am Med Inform Assoc 2006; Sep 13 (5) 547-56.
30 Koppel R, Metlay JP, Cohen A, Abaluck B, Localio AR, Kimmel SE. et al. Role of computerized physician order entry systems in facilitating medication errors. JAMA 2005; Mar 9 293 (10) 1197-203.
31 What we do. Canada Health Infoway. 2012 [cited 2013 Jan 12] Available from: URL: https://www.infoway-inforoute.ca/index.php/about-infoway/what-we-do
32 Olin J. Technology induced errors a new RN concern. RN Central. 2012 May 29 [cited 2013 Jan 12] Available from: URL: http://www.rncentral.com
33 Institute Of Medicine. Health IT and Patient Safety: Building Safer Systems for Better Care. The National Academic Press; Washington DC: 2012
34 Computational Technology for Effective Health Care:Immediate Steps and Strategic Directions. The National Academies Press; 2009
35 Borycki EM, Kushniruk AW, Kuwata S, Kannry J. Engineering the electronic health record for safety: a multi-level video-based approach to diagnosing and preventing technology-induced error arising from usability problems. Stud Health Technol Inform 2011; 166: 197-205.
36 Borycki E, Keay E. Methods to assess the safety of health information systems. Healthc Q 2010; Sep 13 Spec No 47-52.
37 Software regulated as medical device. Health Canada. 2010 December 3 [cited 2013 Jan 12] Available from: URL: http://www.hc-sc.gc.ca/
38 Schumacher RM, Lowry SZ. NIST Guide to the rocesses Approach for Improving the Usability of Electronic Health Records. US National Institute of Standards and Technology; 2010. Nov. Report No.: NISTIR 7741.
39 Patel VL, Kushniruk AW, Yang S, Yale JF. Impact of a computer-based patient record system on data collection, knowledge organization, and reasoning. J Am Med Inform Assoc 2000; Nov 7 (6) 569-85.
40 Ash JS, Berg M, Coiera E. Some unintended consequences of information technology in health care: the nature of patient care information system-related errors. J Am Med Inform Assoc 2004; Mar 11 (2) 104-12.
41 Cheng CH, Goldstein MK, Geller E, Levitt RE. The Effects of CPOE on ICU workflow: an observational study. AMIA Annu Symp Proc 2003; 150-4.
42 Beuscart-Zephir MC, Anceaux F, Menu H, Guerlinger S, Watbled L, Evrard F. User-centred, multidimensional assessment method of Clinical Information Systems: a case-study in anaesthesi- ology. Int J Med Inform 2005; Mar 74 (2-4) 179-89.
43 Ash JS, Sittig DF, Poon EG, Guappone K, Campbell E, Dykstra RH. The extent and importance of unintended consequences related to computerized provider order entry. J Am Med Inform Assoc 2007; Jul 14 (4) 415-23.
44 Koppel R, Wetterneck T, Telles JL, Karsh BT. Workarounds to barcode medication administration systems: their occurrences, causes, and threats to patient safety. J Am Med Inform Assoc 2008; Jul 15 (4) 408-23.
45 Patterson ES, Cook RI, Render ML. Improving patient safety by identifying side effects from introducing bar coding in medication administration. J Am Med Inform Assoc 2002; Sep 9 (5) 540-53.
46 Magrabi F, Ong MS, Runciman W, Coiera E. Patient safety problems associated with heathcare information technology: an analysis of adverse events reported to the US Food and Drug Administration. AMIA Annu Symp Proc 2011; 2011: 853-7.
47 Jaspers MW. A comparison of usability methods for testing interactive health technologies: methodological aspects and empirical evidence. Int J Med Inform 2009; May 78 (5) 340-53.
48 Borycki EM, Kushniruk A, Keay E, Nicoll J, Anderson J, Anderson M. Toward an integrated simulation approach for predicting and preventing technology-induced errors in healthcare: implications for healthcare decision-makers. Healthc Q 2009; 12 Spec No Patient 90-6.
49 Marcilly R, Bernonville S, Riccioli C, Beuscart-Zephir MC. Patient safety-oriented usability testing: a pilot study. Stud Health Technol Inform 2012; 180: 368-72.
50 Kushniruk A, Beuscart-Zephir MC, Grzes A, Borycki E, Watbled L, Kannry J. Increasing the safety of healthcare information systems through improved procurement: toward a framework for selection of safe healthcare systems. Healthc Q 2010; Sep 13 Spec No 53-8.
51 Ash JS, Sittig DF, McMullen CK, Guappone K, Dykstra R, Carpenter J. A rapid assessment process for clinical informatics interventions. AMIA Annu Symp Proc 2008; 26-30.
52 Rule AM, Drincic A, Galt KA. New technology, new errors: how to prime an upgrade of an insulin infusion pump. Jt Comm J Qual Patient Saf 2007; Mar 33 (3) 155-62.
53 Kushniruk AW, Kaufman DR, Patel VL, Levesque Y, Lottin P. Assessment of a computerized patient record system: a cognitive approach to evaluating medical technology. MD Comput 1996; Sep 13 (5) 406-15.
54 Magrabi F, Aarts J, Nohr C, Baker M, Harrison S, Pelayo S. et al. A comparative review of patient safety initiatives for national health information technology. Int J Med Inform. 2012 Dec 18.
55 User interface requirements for the presentation of health data. Standards Australia. 2007 Dec 31 Report No.: HB 306-2007.
56 Common User interface (CUI). NHS Connecting for Health. 2013 [cited 2013 Jan 12] Available from: URL: http://www.connectingforhealth.nhs.uk/systemsandservices/data/cui
57 Sinsky CA, Hess J, Karsh BT, Keller JP, Koppel R. Comparative User Experiences of Health IT Products: How User Experiences Would Be Reported and Used. Discussion Paper, Institute Of Medicine. 2012 September Available from: URL: http://www.iom.edu/Global/Perspectives/2012/ComparativeUserExperienceHIT.aspx
58 Health IT Patient Safety Action and Surveillance Plan for Public Comment. ONC (Office of the National Coordinator for Health Information Technology. 2012 December 21 [cited 2013 Jan 12] Available from: URL: http://www.healthit.gov/
59 CCHIT 2011 Usability Testing Guide for Ambulatory EHR's. CCHIT (Certification Commission for Health Information Technology). 1009 February [cited 2013 Jan 12] Available from: URL: https://www.cchit.org/ambulatory-ehr/
60 Gardner N, Keller E. eHealth Safety — A Journey Begun… An Action Needed… & A Program Under Development. Canada's Health Informatics Association. 2012 May 1 [cited 2013 Jan 12] Available from: URL: http://www.coachorg.com/
61 Guidelines on the qualification and classification of stand alone software used in healthcare within the regulatory framework of medical devices. European Commission DG Health and Consumer 112. [cited 2013 Jan 12] Available from: URL: http://ec.europa.eu/
62 Bras Da Costa S, Pelayo S, Bastien C, Beuscart-Zephir MC. Issues in the implementation of the ISO 62366:2007 standard for medical devices' usability and safety: a case study. CRC Press; 2011
63 Mc Donnell C, Werner K, Wendel L. Electronic Health Record Usability: Vendor Practices and Perspectives. Rockville, MD: Agency for Healthcare Research and Quality; 2010. May. Report No.: AHRQ Publication No. 09(10)-0091-3-EF.
64 Certification services. Canada Health Infoway. 2012 [cited 2013 Dec 1] Available from: URL: https://www.infoway-inforoute.ca/index.php/programs-services/certification-services
65 2010 directory of healthcare IT suppliers. Canadian Healthcare Technology. 2013 [cited 2013 Jan 12] Available from: URL: http://www.canhealth.com/direct10.html
66 Medical devices -- Quality management systems -- Requirements for regulatory purposes. International Organization for Standardization. 2003 Report No.: ISO 1385-2003.
67 Karsh BT. Clinical practice improvement and redesign: How change in workflow can be supported by clinical decision support. Rockville, Maryland: Agency for Healthcare Research and Quality; 2009. Report No.: AHRQ publication N° 09-0054-EF.
68 Berner ES. Clinical Decision Support Systems: State of the Art. 2009 Jun. Report No.: AHRQ Publication No. 09-0069-EF.
69 Carayon P, Karsh BT. Incorporating Health Information Technology into Workflow Redesign-Summary Report. Rockville, MD: Agency for Healthcare Research and Quality; 2010. Oct. Report No.: 10-0098-EF.
70 Agarwal R, Anderson C, Crowley K, Kannan PK. Improving Consumer Health IT Application Development: Lessons From Other Industries — Background Report. Rockville, MD: Agency for Healthcare Research and Quality; 2011. May. Report No.: 11-0065-EF.
71 Lowry SZ, Quinn MT, Ramaiah M, Brick D, Patterson E, Zhang J. et al. A Human Factors Guide to Enhance EHR Usability of Critical User Interactions when Supporting Pediatric Patient Care. NIST (National institute of standards and Technology). 2012 Jun. Report No.: NIST.IR.7865.
72 HIMSS EHR Usability Task Force. Selecting an EHR for Your Practice: Evaluating Usability. 2010
73 Middleton B, Bloomrosen M, Dente MA, Hashmat B, Koppel R, Overhage JM. et al. Enhancing patient safety and quality of care by improving the usability of electronic health record systems: recommendations from AMIA. J Am Med Inform Assoc. 2013 Jan 25.
74 Jokela T. Evaluating the user-centredness of development organisations: conclusions and implications from empirical usability apability maturity assessments. Interacting with Computers 2004; 16 (6) 1095-132.
75 van der PJ, Klein J, Grass C, Freudenthal A. Design for risk control: the role of usability engineering in the management of use-related risks. J Biomed Inform 2012; Aug 45 (4) 795-812.
76 The CIC-IT network. http://www.cic-itfr/en/index.php 2013 [cited 2013 May 10]
77 Beuscart-Zephir MC, Pelayo S, Bernonville S. Example of a Human Factors Engineering approach to a medication administration work system: potential impact on patient safety. Int J Med Inform 2010; Apr 79 (4) e43-e57.
78 AHRQ common formats. AHRQ PSO (Patient Safety Organisations). Website 2013 January [cited 2013 Jan 12] Available from: URL: https://www.psoppc.org/web/patientsafety/commonformats
79 Peute LW, Spithoven R, Bakker PJ, Jaspers MW. Usability studies on interactive health information systems; where do we stand?. Stud Health Technol Inform 2008; 136: 327-32.
80 Peute LW, Driest KF, Marcilly R, Bras Da Costa S, Beuscart-Zephir MC, Jaspers MW. A framework for reporting on Human Factor / Usability studies of Health Information Technologies. Stud Health Technol Inform. In press 2013
81 Bates DW, Kuperman GJ, Wang S, Gandhi T, Kittler A, Volk L. et al. Ten commandments for effective clinical decision support: making the practice of evidence-based medicine a reality. J Am Med Inform Assoc 2003; Nov 10 (6) 523-30.
82 Phansalkar S, Edworthy J, Hellier E, Seger DL, Schedlbauer A, Avery AJ. et al. A review ofhuman factors principles for the design and implementation of medication safety alerts in clinical information systems. J Am Med Inform Assoc 2010; Sep 17 (5) 493-501.
83 Sittig DF, Wright A, Osheroff JA, Middleton B, Teich JM, Ash JS. et al. Grand challenges in clinical decision support. J Biomed Inform 2008; Apr 41 (2) 387-92.
84 Pelayo S, Marcilly R, Bernonville S, Leroy N, Beuscart-Zephir MC. Human factors based recommendations for the design ofmedication related clinical decision support systems (CDSS). Stud Health Technol Inform 2011; 169: 412-6.
85 Horsky J, Schiff GD, Johnston D, Mercincavage L, Bell D, Middleton B. Interface design principles for usable decision support: a targeted review of best practices for clinical prescribing interventions. J Biomed Inform 2012; Dec 45 (6) 1202-16.