Why you need to include human factors in clinical and empirical studies of in vitro point of care devices? Review and future perspectives

References

• Lippi G, Mattiuzzi C, Cervellin G. Point of care troponin testing: rules and regulations. J Electrocardiol. 2013;46(6):727–728.
   PubMed Web of Science ®Google Scholar
• Nichols JH. Quality in point-of-care testing. Expert Rev Mol Diagn. 2003;3(5):563–572.
   PubMed Web of Science ®Google Scholar
• Pauly S, Fisher P, Jacobs E, et al. Regulations and point-of-care testing. Lab Med. 1997;28(8):504–508.
   Google Scholar
• Howick J, Cals JWL, Jones C, et al. Current and future use of point-of-care tests in primary care: an international survey in Australia, Belgium, The Netherlands, the UK and the USA. BMJ Open. 2014;4(8):e005611–e005611.
   PubMed Web of Science ®Google Scholar
• DuBois JA. The role of POCT and rapid testing. Med Lab Observer. 2013;45(9):18.
   PubMedGoogle Scholar
• Jones C, Howick J, Roberts N, et al. Primary care clinicians’ attitudes towards point-of-care blood testing: a systematic review of qualitative studies. BMC Fam Pract. 2013;14(1):117.
   PubMed Web of Science ®Google Scholar
• Laurence CO, Gialamas A, Bubner T, et al. Patient satisfaction with point-of-care testing in general practice. Br J Gen Pract. 2010;60:98–104.
   PubMed Web of Science ®Google Scholar
• Gialamas A, Yelland L, Ryan P, et al. Does point-of-care testing lead to the same or better adherence to medication? A randomised controlled trial: the PoCT in General Practice Trial. Med J Aust. 2009;191(9):487–491.
   PubMed Web of Science ®Google Scholar
• Hurley A, Dnsc RN, Bane A, et al. Nurses’ satisfaction with medication administration point-of-care technology. J Nurs Adm. 2007;37(7/8):343–349.
   PubMed Web of Science ®Google Scholar
• Jackman J, Uy M, Hsieh Y-H, et al. Minding the gap: an approach to determine critical drivers in the development of point-of-care diagnostics. Point Care. 2012;11(2):130–139.
   PubMedGoogle Scholar
• Gurses AP, Ozok AA, Pronovost PJ. Time to accelerate integration of human factors and ergonomics in patient safety. BMJ Qual Saf. 2012;21(4):347–351.
   PubMed Web of Science ®Google Scholar
• Russ AL, Fairbanks RJ, Karsh B-T, et al. The science of human separating fact from fiction. BMJ Qual Saf. 2013;22(10):802–808.
   PubMed Web of Science ®Google Scholar
• ISO. ISO EN 62366:2008 Medical devices – application of usability engineering to medical devices. Brussels: CEN; 2008.
   Google Scholar
• ISO. EN ISO 14971:2012 Medical devices –application of risk management to medical devices. Brussels: CEN; 2012.
   Google Scholar
• Horsky J, Zhang J, Patel VL. To err is not entirely human: Complex technology and user cognition. J Biomed Inform. 2005;38(4):264–266.
   PubMed Web of Science ®Google Scholar
• Medicines and Healthcare products Regulatory Agency. Medical devices – adverse incidents reported to MHRA in 2011 and 2012. London (UK): MHRA; 2014.
   Google Scholar
• ExpertSOLUTIONS S. Stericycle Recall Index Q3 2014. Indianapolis (IN): Stericycle ExpertSOLUTIONS; 2014.
   Google Scholar
• Meier FA, Jones BA. Point-of-care testing error: sources and amplifiers, taxonomy, prevention strategies, and detection monitors. Arch Pathol Lab Med. 2005;129(10):1262–1267.
   PubMed Web of Science ®Google Scholar
• Velez D, Shanblatt M. Taxonomy of current medical devices for POCT applications and the potential acceptance of Bluetooth technology for secure interoperable applications. In: 2011 13th IEEE International Conference on e-Health Networking Applications and Services (Healthcom). Columbia, MO: IEEE; 2011.
   Google Scholar
• Vincent C, Blandford A. Designing for safety and usability: user-centered techniques in medical device design practice. Proc Hum Factors Ergon Soc Annu Meet. 2011;55(1):793–797.
   Google Scholar
• Carayon P, Wetterneck TB, Rivera-Rodriguez AJ, et al. Human factors systems approach to healthcare quality and patient safety. Appl Ergon. 2014;45(1):14–25.
   PubMed Web of Science ®Google Scholar
• Cohen MR. Why error reporting systems should be voluntary: they provide better information for reducing errors. Br Med J. 2000;320(7237):728–729.
   PubMed Web of Science ®Google Scholar
• Senders JW. Chapter 9: medical devices, medical errors, and medical accidents. In: Bogner MS, editor. Human error in medicine. Hillsdale (NJ): Lawrence Erlbaum Associates; 1994.
   Google Scholar
• Gawron VJ, Drury CG, Fairbanks RJ, et al. Medical error and human factors engineering: where are we now? Am J Med Qual. 2006;21(1):57–67.
   PubMed Web of Science ®Google Scholar
• Kirwan B. Human reliability assessment. In: Wilson JR, Sharples S, editors. Evaluation of human work. Boca Raton (FL): CRC Press; 2015.
   Google Scholar
• Hendrick HW, Kleiner BM. Macroergonomics: an introduction to work system design. Santa Monica (CA): Human Factors and Ergonomics Society; 2001.
   Google Scholar
• Hignett S, Carayon P, Buckle P, et al. State of science: human factors and ergonomics in healthcare. Ergonomics. 2013;56(10):1491–1503.
   PubMed Web of Science ®Google Scholar
• Ward J, Buckle P, John Clarkson P. Designing packaging to support the safe use of medicines at home. Appl Ergon. 2010;41(5):682–694.
   PubMed Web of Science ®Google Scholar
• Buckle P, Clarkson PJ, Coleman R, et al. Systems mapping workshops and their role in understanding medication errors in healthcare. Appl Ergon. 2010;41(5):645–656.
   PubMed Web of Science ®Google Scholar
• Jun GT, Ward J, Morris Z, et al. Health care process modelling: which method when? Int J Qual Health Care. 2009;21(3):214–224.
   PubMed Web of Science ®Google Scholar
• Jun GT, Ward J, Clarkson PJ. Systems modelling approaches to the design of safe healthcare delivery: ease of use and usefulness perceived by healthcare workers. Ergonomics. 2010;53(7):829–847.
   PubMed Web of Science ®Google Scholar
• Jiancaro T, Jamieson GA, Mihailidis A. Twenty years of cognitive work analysis in health care: a scoping review. J Cogn Eng Decis Making. 2014;8(1):3–22.
   Google Scholar
• Lim RHM, Anderson JE, Buckle PW. Work domain analysis for understanding medication safety in care homes in England: an exploratory study. Ergonomics. 2015;58(4):1–12.
   PubMedGoogle Scholar
• Lane R, Stanton NA, Harrison D. Applying hierarchical task analysis to medication administration errors. Appl Ergon. 2006;37(5):669–679.
   PubMed Web of Science ®Google Scholar
• Carayon P. Human factors of complex sociotechnical systems. Appl Ergon. 2006;37(4):525–535.
   PubMed Web of Science ®Google Scholar
• Zink KJ. Ergonomics in the past and the future: from a German perspective to an international one. Ergonomics. 2000;43(7):920–930.
   PubMed Web of Science ®Google Scholar
• Dillon A. Group dynamics meet cognition: combining socio-technical concepts and usability engineering in the design of information systems. In: Coakes E, Willis D, Lloyd-Jones R, editors. The New SocioTech. London: Springer; 2000.
   Google Scholar
• Carayon P, Karsh B-T, Gurses AP, et al. Macroergonomics in healthcare quality and patient safety. Rev Hum Factors Ergon. 2013;8(1):4–54.
   PubMedGoogle Scholar
• Wilson JR, Sharples S. Methods in the understanding of human factors. Boca Raton (FL): CRC Press; 2015.
   Google Scholar
• Borsci S, Kurosu M, Federici S, et al. Computer systems experiences of users with and without disabilities: an evaluation guide for professionals – Chapter 7: how you can set up and perform an interaction evaluation rules and methods. Boca Raton (FL): CRC Press; 2013.
   Google Scholar
• Federici S, Borsci S. Usability evaluation: models, methods, and applications. In: International Encyclopedia of Rehabilitation. Stone JH, Blouin M, 2010. Available from: http://cirrie.buffalo.edu/encyclopedia/en/article/277/
   Google Scholar
• ISO. ISO 9241-11:1998 Ergonomic requirements for office work with visual display terminals. Brussels: CEN; 1998.
   Google Scholar
• ISO. ISO 9241-210:2010 Ergonomics of human-system interaction – part 210: human-centred design for interactive systems. Brussels: CEN; 2010.
   Google Scholar
• Venkatesh V, Davis FD. A theoretical extension of the technology acceptance model: four longitudinal field studies. Manage Sci. 2000;46(2):186–204.
   Web of Science ®Google Scholar
• Davis FD. Perceived usefulness, perceived ease of use, and user acceptance of information technology. MIS Q. 1989;13(3):319–340.
   Web of Science ®Google Scholar
• Lankton N, McKnight DH, Thatcher JB. Incorporating trust-in-technology into expectation disconfirmation theory. J Strategic Inf Syst. 2014;23(2):128–145.
   Web of Science ®Google Scholar
• Salanitri D, Hare C, Borsci S, et al. Relationship between trust and usability in virtual environments: an ongoing study. In: Kurosu M, editor. Human-computer interaction: design and evaluation. Proceedings of 17th International Conference on HCI 2015, Los Angeles, CA, 2–7 Aug. Cham: Springer International Publishing; 2015.
   Google Scholar
• Borsci S, Kuljis J, Barnett J, et al. Beyond the user preferences: aligning the prototype design to the users’ expectations. Hum Factors Ergon Manuf Serv Ind. 2016;26(1):16–39.
   Web of Science ®Google Scholar
• Lee S, Koubek RJ. Understanding user preferences based on usability and aesthetics before and after actual use. Interact Comput. 2010;22(6):530–543.
   Web of Science ®Google Scholar
• Lee S, Koubek RJ. The impact of cognitive style on user preference based on usability and aesthetics for computer-based systems. Int J Hum Comput Interact. 2011;27(11):1083–1114.
   Web of Science ®Google Scholar
• Sharples S, Cobbs S. Methods for collecting and observing participants responses. In: Wilson JR, Sharples S, editors. Evaluation of human work. Boca Raton (FL): CRC Press; 2015.
   Google Scholar
• Money A, Barnett J, Kuljis J, et al. The role of the user within the medical device design and development process: medical device manufacturers’ perspectives. BMC Med Inform Decis Mak. 2011;11(1):1–12.
   PubMed Web of Science ®Google Scholar
• Brooke J. SUS: a “quick and dirty” usability scale. In: Jordan PW, Thomas B, Weerdmeester BA, et al., editors. Usability evaluation in industry. London: Taylor & Francis; 1996.
   Google Scholar
• Hassenzahl M. Hedonic, emotional, and experiential perspectives on product quality. In: Ghaoui C, editor. Encyclopedia of human computer interaction. Hershey (PA): Information Science Reference; 2006.
   Google Scholar
• Hart SG, Staveland LE. Development of NASA-TLX (Task Load Index): results of empirical and theoretical research. Adv Psychol. 1988;52:139–183.
   Google Scholar
• Junker R, Schlebusch H, Luppa PB. Point-of-care testing in hospitals and primary care. Dtsch Ärztebl Int. 2010;107(33):561–567.
   PubMed Web of Science ®Google Scholar
• National Institutes of Health. FACT SHEET – point-of-care diagnostic testing. In: Research Portfolio Online Reporting Tools. USA: NIH RePORT; 2010.
   Google Scholar
• Kushniruk AW, Triola MM, Borycki EM, et al. Technology induced error and usability: the relationship between usability problems and prescription errors when using a handheld application. Int J Med Inform. 2005;74(7–8):519–526.
   PubMed Web of Science ®Google Scholar
• Stricklin MLV, Struk CM. Point of care technology: a sociotechnical approach to home health implementation. Methods Inf Med. 2003;42(4):463–470.
   PubMed Web of Science ®Google Scholar
• Cals JWL, Chappin FHF, Hopstaken RM, et al. C-reactive protein point-of-care testing for lower respiratory tract infections: a qualitative evaluation of experiences by GPs. Fam Pract. 2010;27(2):212–218.
   PubMed Web of Science ®Google Scholar
• Wood F, Brookes-Howell L, Hood K, et al. A multi-country qualitative study of clinicians’ and patients’ views on point of care tests for lower respiratory tract infection. Fam Pract. 2011;28(6):661–669.
   PubMed Web of Science ®Google Scholar
• Agustí C, Fernàndez-López L, Mascort J, et al. Acceptability of rapid HIV diagnosis technology among primary healthcare practitioners in Spain. AIDS Care. 2013;25(5):544–549.
   PubMed Web of Science ®Google Scholar
• Bello FA, Ogunbode OO, Adesina OA, et al. Acceptability of counselling and testing for HIV infection in women in labour at the University College Hospital, Ibadan, Nigeria. Afr Health Sci. 2011;11(1):30–35.
   PubMed Web of Science ®Google Scholar
• Iqbal S, De Souza LR, Yudin MH. Acceptability, predictors and attitudes of Canadian women in labour toward point-of-care HIV testing at a single labour and delivery unit. Can J Infect Dis Med Microbiol. 2014;25(4):201–206.
   PubMed Web of Science ®Google Scholar
• Schalkwyk J, Amiri N, Lalji S, et al. Acceptance of a rapid herpes test in labour: survey of attitudes of patients and health care providers. J Obstet Gynaecol Can. 2008;30(9):776–780.
   PubMedGoogle Scholar
• Cals J, van Weert H. Point-of-care tests in general practice: Hope or hype? Eur J Gen Pract. 2013;19(4):251–256.
   PubMed Web of Science ®Google Scholar
• US FDA. Draft guidance for industry and food and drug administration staff – applying human factors and usability engineering to optimize medical device design. Silver Spring (MD): US FDA; 2011.
   Google Scholar
• Laurence C, Gialamas A, Yelland L, et al. A pragmatic cluster randomised controlled trial to evaluate the safety, clinical effectiveness, cost effectiveness and satisfaction with point of care testing in a general practice setting – rationale, design and baseline characteristics. Trials. 2008;9(1):50.
   PubMed Web of Science ®Google Scholar
• Butler CC, Simpson S, Wood F. General practitioners’ perceptions of introducing near-patient testing for common infections into routine primary care: A qualitative study. Scand J Prim Health Care. 2008;26(1):17–21.
   PubMed Web of Science ®Google Scholar
• Bulterys M, Jamieson DJ, O’Sullivan MJ, et al. Rapid HIV-1 testing during labor: A multicenter study. J Am Med Assoc. 2004;292(2):219–223.
   Web of Science ®Google Scholar
• Heller T, Kunthea S, Bunthoeun E, et al. Point-of-care HIV testing at antenatal care and maternity sites: experience in Battambang Province, Cambodia. Int J STD AIDS. 2011;22(12):742–747.
   PubMed Web of Science ®Google Scholar
• Agustí C, Fernàndez-López L, Mascort J, et al. Attitudes to rapid HIV testing among Spanish General Practitioners. HIV Med. 2013;14(Suppl. 3):53–56.
   PubMed Web of Science ®Google Scholar
• Conners EE, Hagedorn HJ, Butler JN, et al. Evaluating the implementation of nurse-initiated HIV rapid testing in three Veterans Health Administration substance use disorder clinics. Int J STD AIDS. 2012;23(11):799–805.
   PubMed Web of Science ®Google Scholar
• Chen JC, Goetz MB, Feld JE, et al. A provider participatory implementation model for HIV testing in an ED. Am J Emerg Med. 2011;29(4):418–426.
   PubMed Web of Science ®Google Scholar
• Merchant RC, Clark MA, Seage GR, et al. Emergency department patient perceptions and preferences on opt-in rapid HIV screening program components. AIDS Care. 2009;21(4):490–500.
   PubMed Web of Science ®Google Scholar
• Wurcel A, Zaman T, Zhen S, et al. Acceptance of HIV antibody testing among inpatients and outpatients at a public health hospital: a study of rapid versus standard testing. AIDS Patient Care STDS. 2005;19(8):499–505.
   PubMed Web of Science ®Google Scholar
• Mayega RW, Guwatudde D, Makumbi FE, et al. Comparison of fasting plasma glucose and haemoglobin A1c point-of-care tests in screening for diabetes and abnormal glucose regulation in a rural low income setting. Diabetes Res Clin Pract. 2014;104(1):112–120.
   PubMed Web of Science ®Google Scholar
• Weigl BH, Zwisler G, Peck R, et al. Rapid screening test for gestational diabetes – public health need, market requirement, initial product design, and experimental results. In: Proceedings of SPIE – The International Society for Optical Engineering, San Francisco, CA, USA; 2013.
   Google Scholar
• Bienek DR, Perez NM. Diagnostic accuracy of a point-of-care blood typing kit conducted by potential end users. Mil Med. 2013;178(5):588–592.
   PubMed Web of Science ®Google Scholar
• Shephard MDS, Spaeth B, Mazzachi BC, et al. Design, implementation and initial assessment of the Northern Territory Point-of-Care Testing Program. Aust J Rural Health. 2012;20(1):16–21.
   PubMed Web of Science ®Google Scholar
• Loten C, Attia J, Hullick C, et al. Point of care troponin decreases time in the emergency department for patients with possible acute coronary syndrome: a randomised controlled trial. Emerg Med J. 2010;27(3):194–198.
   PubMed Web of Science ®Google Scholar
• Kong M, Lim T, Ng H, et al. Feasibility, cost-effectiveness and patients’ acceptance of point-of-care INR testing in a hospital-based anticoagulation clinic. Ann Hematol. 2008;87(11):905–910.
   PubMed Web of Science ®Google Scholar
• Seto E, Chagpar A, Roach C, et al. Usability evaluations as part of the procurement process: case study of hospital point of care carts. In: Proceedings of the Human Factors and Ergonomics Society; 2006.
   Google Scholar
• Ferris DG, Dickman ED, Litaker MS, et al. Patient acceptance of fluorescent and reflective spectroscopy as a replacement test for the pap smear. J Low Genit Tract Dis. 2003;7(4):294–298.
   PubMedGoogle Scholar
• Kost GJ. Preventing medical errors in point-of-care testing. Arch Pathol Lab Med. 2001;125(10):1307–1315.
   PubMed Web of Science ®Google Scholar
• Lewis JR. Introduction to the special issue on usability and user experience: psychometrics. Int J Hum Comput Interact. 2015;31(8):481–483.
   Web of Science ®Google Scholar
• Kost GJ, Ferguson WJ, Kost LE. Principles of point of care culture, the spatial care pathTM, and enabling community and global resilience. Electron J Int Fed Clin Chem. 2014;25:4–23.
   Google Scholar
• Kost GJ, Zhou Y, Katip P. Point of care culture survey. In: Kost GJ, Curtis CM, editors. Global point of care: strategies for disasters, emergencies, and public health resilience. Washington (DC): American Association for Clinical Chemistry Press; 2015.
   Google Scholar
• Curtis CM, Louie RF, Kost GJ. The current and future status of point of care in national disaster caches. In: Kost GJ, Curtis CM, editors. Global point of care: strategies for disasters, emergencies, and public health resilience. Washington (DC): American Association for Clinical Chemistry Press; 2015.
   Google Scholar
• Kost GJ, Louie RF, Curtis CM, et al. The logic web of future global resilience. In: Kost GJ, Curtis CM, editors. Global point of care: strategies for disasters, emergencies, and public health resilience. Washington (DC): American Association for Clinical Chemistry Press; 2015.
   Google Scholar
• Kost GJ, Louie RF, Truong A-T, et al. A global perspective of needs assessment for rapid decision making in pandemics, complex emergencies, and disasters. In: Kost GJ, Curtis CM, editors. Global point of care: strategies for disasters, emergencies, and public health resilience. Washington (DC): American Association for Clinical Chemistry Press; 2015.
   Google Scholar
• Kost GJ, Zhou Y, Katip P. Understanding point of care culture improves resiliency and standards of care in resource-limited countries. In: Kost GJ, Curtis CM, editors. Global point of care: strategies for disasters, emergencies, and public health resilience. Washington (DC): American Association for Clinical Chemistry Press; 2015.
   Google Scholar
• Dhawan AP, Heetderks WJ, Pavel M, et al. Current and future challenges in point-of-care technologies: a paradigm-shift in affordable global healthcare with personalized and preventive medicine. IEEE J Transl Eng Health Med. 2015;3:1–10.
   Google Scholar
• Weiser M. The computer for the 21st century. SIGMOBILE Mob Comput Commun Rev. 1999;3(3):3–11.
   Google Scholar
• Jordan P. Designing pleasurable products: an introduction to the new human factors. London: Taylor & Francis; 2002.
   Google Scholar