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Simulation as an ethical imperative and epistemic responsibility for the implementation of medical guidelines in health care

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Abstract

Guidelines orient best practices in medicine, yet, in health care, many real world constraints limit their optimal realization. Since guideline implementation problems are not systematically anticipated, they will be discovered only post facto, in a learning curve period, while the already implemented guideline is tweaked, debugged and adapted. This learning process comes with costs to human health and quality of life. Despite such predictable hazard, the study and modeling of medical guideline implementation is still seldom pursued. In this article we argue that to systematically identify, predict and prevent medical guideline implementation errors is both an epistemic responsibility and an ethical imperative in health care, in order to properly provide beneficence, minimize or avoid harm, show respect for persons, and administer justice. Furthermore, we suggest that implementation knowledge is best achieved technically by providing simulation modeling studies to anticipate the realization of medical guidelines, in multiple contexts, with system and scenario analysis, in its alignment with the emerging field of implementation science and in recognition of learning health systems. It follows from both claims that it is an ethical imperative and an epistemic responsibility to simulate medical guidelines in context to minimize (avoidable) harm in health care, before guideline implementation.

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References

  • Ash, J., et al. 2004. Some unintended consequences of information technology in health care: The nature of patient care information system-related errors. Journal of the American Medical Informatics Association 11: 104–112.

    Article  Google Scholar 

  • Banks, J. (ed.). 1998. Handbook of simulation: Principles, methodology, advances, applications, and practice. New York: John Wiley.

    Google Scholar 

  • Beauchamp, T., and J. Childress. 2008. Principles of biomedical ethics, 6th ed. Oxford: Oxford Univ. Press.

    Google Scholar 

  • Caro, J., A.H. Briggs, U. Siebert, and K. Kuntz. 2012. Modeling good research practices-overview: A report of the ISPOR-SMDM modeling good research practices task force–1. Value Health 15(6): 796–803.

    Article  Google Scholar 

  • Casalino, P. 1999. The unintended consequences of measuring quality on the quality of medical care. NEJM 341(15): 1147–1150.

    Article  Google Scholar 

  • Code, L. 1987. Epistemic responsibility. Hanover: University Press of New England and Brown Univ. Press.

    Google Scholar 

  • Eccles, M.P., J.M. Grimshaw, P. Shekelle, H.J. Schunemann, and S. Woolf. 2012. Developing clinical practice guidelines: Target audiences, identifying topics for guidelines, guideline group composition and functioning and conflicts of interest. Implementation Science 7: 60.

    Article  Google Scholar 

  • Field, M.J., and K. Lohr, eds.; Committee to Advise the Public Health Service on Clinical Practice Guidelines Institute of Medicine. 1990. Clinical practice guidelines: Directions for a new program. Washington, DC: National Academy Press.

  • Gagliardi, A.R., and M.C. Borrowers. 2012. Integrating guideline development and implementation: analysis of guideline development manual instructions for generating implementation advice. Implementation Science 7: 67.

    Article  Google Scholar 

  • Garbayo, L. 2014. Epistemic considerations on expert disagreement, normative justification, and inconsistency regarding multi-criteria decision making. In Constraint programming and decision making: Studies in computational intelligence, Vol. 539, 35–45.

  • Harrell, C., B. Ghosh, and R. Bowden. 2000. Simulation using ProModel. New York: McGraw Hill.

    Google Scholar 

  • Harrison, et al. 2013. Guideline adaptation and implementation planning: a prospective observational study. Implementation Science 8: 49. doi:10.1186/1748-5908-8-49.

  • IOM (Institute of Medicine) and NAE (National Academy of Engineering). 2011. Engineering a learning healthcare system a look at the future: Workshop summary, Learning health system series. Washington, DC: National Academies Press.

  • Karnon, J., J. Stahl, A. Brennan, J.J. Caro, J. Mar, and J. Moller. 2012. Modeling using discrete event simulation: A report of the ISPOR-SMDM modeling good research practices task force–4. Value Health 15(6): 821–827.

    Article  Google Scholar 

  • Kitson, A.L., J. Rycroft-Malone, G. Harvey, B. McCormack, K. Seers, and A. Titchen. 2008. Evaluating the successful implementation of evidence into practice using the PARiHS framework: Theoretical and practical challenges. Implementation Science 3: 1. doi:10.1186/1748-5908-3-1.

    Article  Google Scholar 

  • Kuntz, K., F. Sainfort, M. Butler, B. Taylor, S. Kulasingam, S. Gregory, et al. 2013. Decision and simulation modeling in systematic reviews. Rockville, MD: Agency for Healthcare Research and Quality (US); 2013 Feb. Report No.: 11(13)-EHC037-EF.

  • Madon, T., K. Hofman, L. Kupfer, and R. Glass. 2007. Implementation science. Science 318(5857): 1728–1729.

    Article  Google Scholar 

  • Merton, R. 1936. The unanticipated consequences of purposive social action. American Sociological Review 1(6): 894–904.

    Article  Google Scholar 

  • Nagel, T. 1993. Moral luck. In Moral luck. SUNY series in ethical theory, ed. D. Statman. Albany: SUNY Press.

    Google Scholar 

  • NINDS, and NIH. 1996. In Proceedings of a National Symposium on Rapid Identification and Treatment of Acute Stroke. Bethesda, MD.

  • Pitman, R., D. Fisman, G.S. Zaric, M. Postma, M. Kretzschmar, J. Edmunds, and M. Brisson. 2012. Dynamic transmission modeling: A report of the ISPOR-SMDM modeling good research practices task force–5. Value Health 15(6): 828–834.

    Article  Google Scholar 

  • Roberts, M., L.B. Russell, A.D. Paltiel, M. Chambers, P. McEwan, and M. Krahn. 2012. Conceptualizing a model: A report of the ISPOR-SMDM modeling good research practices task force–2. Value Health 15(6): 804–811.

    Article  Google Scholar 

  • Shekelle, P., S. Woolf, J.M. Grimshaw, H.J. Schunemann, and M.P. Eccles. 2012. Developing clinical practice guidelines: Reviewing, reporting, and publishing guidelines; updating guidelines; and the emerging issues of enhancing guideline implementability and accounting for comorbid conditions in guideline development. Implementation Science 7: 62.

    Article  Google Scholar 

  • Siebert, U., O. Alagoz, A. Bayoumi, B. Jahn, D. Owens, D. Cohen, and K. Kuntz. 2012. State-transition modeling: A report of the ISPOR-SMDM modeling good research practices task force–3. Value Health 15(6): 812–820.

    Article  Google Scholar 

  • Solomon, M. 2010. The ethical urgency of advancing implementation science. American Journal of Bioethics 10(8): 31–32.

    Article  Google Scholar 

  • Solomon, M., and A. Bonham, eds. 2013. Ethical oversight of learning health care systems. Hastings Center Special Report 43(1): S1–S44.

  • Stahl, J.E., K.L. Furie, S. Gleason, and G.S. Gazelle. 2003. Stroke: Effect of implementing an evaluation and treatment protocol compliant with NINDS recommendations. Radiology 228(3): 659–668.

    Article  Google Scholar 

  • US Preventive Services Task Force. 2009. Screening for breast cancer: U.S. Preventive Services Task Force recommendation statement. Annals of Internal Medicine 151(10): 716–726.

    Article  Google Scholar 

  • Woolf, S., H.J. Schunemann, M.P. Eccles, J.M. Grimshaw, and P. Shekelle. 2012. Developing clinical practice guidelines: Types of evidence and outcomes; values and economics, synthesis, grading, and presentation and deriving recommendations. Implementation Science 7: 61.

    Article  Google Scholar 

  • Zagzebski, L. 2001. Recovering understanding. In Knowledge truth, and duty: Essays on epistemic justification, responsibility, and virtue, ed. Matthias Steup. Oxford: Oxford Univ. Press.

    Google Scholar 

Download references

Acknowledgments

Profs. Garbayo and Stahl wrote the bulk of this paper while collaborating doing research at the Massachusetts General Hospital - Institute for Technology Assessment 101 Merrimac St, 10th Floor Boston, MA 02114. The authors would like to acknowledge the helpful feedback of Prof. Dan Wickler (Harvard School of Public Health) on the discussion of moral responsibility and luck in health care, and of Prof. Mildred Solomon (Hastings Center/Harvard Medical School) on the overall ethics challenges pertaining to learning health systems. Prof. Garbayo was a visiting scholar at MGH-ITA, and at the Hastings Center, where this work was first presented and discussed. She received support from ITA/MGH, Hastings Center & UT El Paso Research Grant. She would like to thank ITA/MGH, Hastings Center and UT El Paso for their gracious support.

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Correspondence to Luciana Garbayo.

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Garbayo, L., Stahl, J. Simulation as an ethical imperative and epistemic responsibility for the implementation of medical guidelines in health care. Med Health Care and Philos 20, 37–42 (2017). https://doi.org/10.1007/s11019-016-9719-0

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