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The Culture of Health Care Evidence-Based Practice Welcome to The Culture of Health Care: Evidence-Based Practice. This is Lecture a. The component, The Culture of Health Care, addresses job expectations in health care settings. It discusses how care is organized within a practice setting, privacy laws, and professional and ethical issues encountered in the workplace. Lecture a This material (Comp 2 Unit 5) was developed by Oregon Health & Science University, funded by the Department of Health and Human Services, Office of the National Coordinator for Health Information Technology under Award Number IU24OC000015. This material was updated in 2016 by Bellevue College under Award Number 90WT0002. This work is licensed under the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/4.0/.

Evidence-Based Practice Learning Objectives Define the key tenets of evidence-based medicine (EBM) and its role in the culture of health care (Lectures a, b). Construct answerable clinical questions and critically appraise evidence answering them (Lecture b). Explain how EBM can be applied to intervention studies, including the phrasing of answerable questions, finding evidence to answer them, and applying them to given clinical situations (Lecture c). Describe how EBM can be applied to key clinical questions of diagnosis, harm, and prognosis (Lectures d, e). Discuss the benefits and limitations to summarizing evidence (Lecture f). Describe how EBM is used in clinical settings through clinical practice guidelines and decision analysis (Lecture g). The objectives for Evidence-Based Practice are to: Define the key tenets of evidence-based medicine (EBM) and its role in the culture of health care. Construct answerable clinical questions and critically appraise evidence answering them. Explain how EBM can be applied to intervention studies, including the phrasing of answerable questions, finding evidence to answer them, and applying them to given clinical situations. Describe how EBM can be applied to key clinical questions of diagnosis, harm, and prognosis. Discuss the benefits and limitations to summarizing evidence. Describe how EBM is used in clinical settings through clinical practice guidelines and decision analysis.

What Is Evidence-Based Medicine (EBM)? A set of tools and a disciplined approach to informing clinical decision making Applies the best evidence available But remember the caveat: “Absence of evidence is not evidence of absence” (Martin Rees) Allows clinical experience (art) to be integrated with best clinical science Makes medical literature more clinically applicable and relevant This lecture is an introduction to the unit topic, evidence-based medicine. Evidence-based medicine, or EBM [E-B-M], is a set of tools and a disciplined approach to informing clinical decision making. We apply the best scientific evidence available to various clinical questions. We learn to seek out the best evidence and to use it appropriately, but we must remember that the absence of evidence is not evidence of absence. Although this caveat is attributed to Martin Rees, a cosmologist and astrophysicist, its applicability to medicine is pertinent. It means we must consider not only the evidence we have but also evidence that may be missing and how that missing evidence might influence our decision making. EBM allows clinical experience—or the art of medicine—to be integrated with the best science, making the medical literature more clinically applicable and relevant.

Why Are We Not Evidence-Based? Thomas Kida (2006) lists six ways we arrive at false beliefs: We prefer stories to statistics. We seek to confirm, not to question, our ideas. We rarely appreciate the role of chance and coincidence in shaping events. We sometimes misperceive the world around us. We tend to oversimplify our thinking. Our memories are often inaccurate. So what’s the big deal about evidence-based medicine? Why aren’t we evidence-based in everything we do? Some interesting writings from the popular press talk about how we humans arrive at decisions and how we apply evidence not just in medicine but in everything we do. Thomas Kida’s book Don’t Believe Everything You Think describes six ways that humans come to false beliefs. One is that we tend to prefer stories over statistics. Another is that we often seek to confirm and not to question our ideas. Yet another issue is that humans rarely appreciate the role of chance and coincidence in shaping events, although those of us exposed to EBM are hopefully a little better at that. Sometimes we misperceive what’s going on in the world around us. Sometimes we oversimplify our thinking, and human memories are often inaccurate. We don’t always remember events exactly as they occurred, especially over time.

Growing Advocacy for Medicine Being More Evidence-Based “Effectiveness” was one of six attributes advocated in IOM’s Crossing the Quality Chasm (Source: Institute of Medicine, 2001) Report advocates in detail the use of informatics for a “learning health care system” (Source: Eden, Wheatley, McNeil, & Sox, 2008) “Descriptions of Methodological Details and Challenges for EBM,” in Medical Care (Source: Medical Care, 2007) EBM key points in JAMA (Source: Guyatt & Voelker, 2015) There’s a growing advocacy for the practice of medicine to be more evidence based. The Institute of Medicine, in its report Crossing the Quality Chasm [kazm], names effectiveness as one of the six attributes of the high-quality 21st-century health care system, citing the use of EBM principles. Another report in this series talks about the “learning health care system” in which we learn from what we do. Naturally, the main way to learn from what we do is to collect data and analyze it, which can be done without computer-based information systems. However, information systems greatly facilitate the ability to analyze data—including the ability to perform data comparisons and trend analyses. Information systems also significantly increase the speed at which analysis can be done. Improved data analysis capabilities have opened new ways for us to learn what works and what doesn’t work in health care. EBM entails many methodological details and challenges. We cover some of them in this unit. More detailed descriptions of these challenges are found in a 2007 supplement to the journal Medical Care, and key points of EBM are presented in a 2015 JAMA article, “Everything You Ever Wanted to Know about Evidence-Based Medicine.”

“Cultural” Pushback on EBM Not everyone agrees with the experimentally oriented approach of EBM (Source: Luce et al., 2009) Some criticisms of EBM are valid (Source: Cohen, Stavri, & Hersh, 2004) Challenges physician-patient autonomy Focuses on large-scale, randomized controlled trials that homogenize individual differences Concerns about manipulations of clinical trials data and reports This unit explores the details of EBM, but it should be noted that there’s some cultural pushback to this concept. Not everyone agrees with the EBM approach and instead prefer other approaches for gaining knowledge, such as experience and observation. There are also some valid criticisms of EBM. EBM, in some sense, challenges physician-patient autonomy by having a very rigid view of what evidence is to be applied in decision making for patient care. EBM tends to focus on large-scale, randomized control trials that homogenize or take away individual differences. Finally, there are concerns about manipulation of clinical trial data and reports that don’t undermine the principles of EBM but show that, in practice, it has some shortcomings.

The New EBM Mantra: Comparative Effectiveness Research (CER) Achieved prominence when American Recovery and Reinvestment Act (ARRA) allocated $1.1 billion for CER Required preparation of two reports to inform operational plan: Federal Coordinating Council for Comparative Effectiveness Research (2009) Defined CER (next slide) Called for development not only of research but also of human and scientific capital, data infrastructure, and dissemination IOM report for prioritizing research (Committee on Comparative Effectiveness Research Prioritization, Board on Health Care Services, & Institute of Medicine, 2009) Identified top 100 research priorities One of the new focuses of the EBM community is comparative effectiveness research, or CER [C-E-R]. Like health information technology, CER has achieved highly visible prominence through its funding in the American Recovery and Reinvestment Act, or ARRA [err-uh]. Completely aside from all the health information technology (IT [eye-tee]) funding, the stimulus bill allocated one-point-one billion dollars for CER. ARRA also stipulated that two reports be prepared to inform the operational plan for CER. These reports were published in June 2009—one by the Federal Coordinating Council for CER and the other by the Institute of Medicine, prioritizing research topics. The Federal Coordinating Council report defined CER, which is covered in the next slide. The report called for emphasis not only on the research that needs to be done but also on other aspects around CER, such as human and scientific capital. CER requires developing individuals with the expertise to do the research; scientific methodology to carry it out; data infrastructure, including registries, data warehouses, and other electronic data sources, to support it; and a mechanism to disseminate this research to decision makers, patients, clinicians, and policymakers. The Institute of Medicine report prioritized 100 top research objectives that address not only common diseases that require a lot of resources to treat but also issues around health care delivery and health disparities.

CER Definition of CER from Federal Coordinating Council report “Research comparing different interventions and strategies to prevent, diagnose, treat and monitor health conditions” “Must assess a comprehensive array of health-related outcomes for diverse patient populations” “Necessitates the development, expansion, and use of a variety of data sources and methods” (informatics!) Healthcare reform legislation (Affordable Care Act, ACA) allocated funding for Patient-Centered Outcomes Research Institute (PCORI, http://www.pcori.org) Independent body with multiple stakeholder representation to advance and carry out research in CER (Washington, 2011) Some key points of the Federal Coordinating Council’s definition of comparative effectiveness research are summarized here. CER is research comparing different interventions and strategies to prevent, diagnose, treat, and monitor health conditions. The key aspect of CER is that it directly compares two or more existing treatments or interventions to determine the effectiveness, benefits, and risks of each. For example, CER might compare two sleep medications head to head to determine which is best under specific conditions—what it wouldn’t do is draw conclusions from separate studies comparing each sleep medication with a placebo. Beyond the research, [quote] “CER must assess a comprehensive array of health-related outcomes for diverse patient populations.”[end quote] In other words, CER must consider factors such as gender and ethnic diversity as well as patients who have chronic conditions or multiple conditions that interact with each other. Finally, one point relevant especially to informatics [in-fer-mat-iks] is that CER necessitates the development, expansion, and use of a variety of data sources, such as clinical trial and electronic health records, as well as methods, such as data mining algorithms, that gather useful information while also adhering to confidentiality laws. Furthering the agenda of CER is a mandate in the federal health reform legislation (the Affordable Care Act, or ACA [ay-see-ay]) for the funding of the Patient-Centered Outcomes Research Institute, or PCORI [pee-core-ee] (www.pcori.org), an independent body with multiple stakeholder representation, to advance and carry out research in CER. PCORI’s latest reports and research materials are publically available on the organization’s website.

Unit Topics Definitions and Application of EBM Intervention Diagnosis Harm and Prognosis Summarizing Evidence Putting Evidence into Practice The next lecture in this unit begins with definitions and applications of EBM. We then look at the major questions that EBM tries to answer: clinical questions about intervention, diagnosis, harm, and prognosis. We look at techniques for summarizing evidence, such as systematic reviews and medical analyses that bring multiple studies together to give us a comprehensive picture of the research topic. We then look at some approaches to putting evidence into practice, including clinical guidelines and decision analysis.

Evidence-Based Practice Summary – Lecture a EBM is an approach to informing clinical decision making that applies the best evidence available Allows clinical experience (art) to be integrated with best clinical science Makes medical literature more clinically applicable and relevant This concludes Lecture a, of Evidence-Based Practice. In summary, EBM is an approach to informing clinical decision making that applies the best evidence available. It allows clinical experience or the art of medicine-- to be integrated with the best clinical science and makes medical literature more clinically applicable and relevant.

Evidence-Based Practice References – Lecture a Brush, J. E., & Halperin, J. L. (2016). A baby in the bathwater: Preserving evidence-based medicine. Journal of the American College of Cardiology, 68(2), 214-216. Retrieved from http://www.onlinejacc.org/content/68/2/214 Committee on Comparative Effectiveness Research Prioritization, Board on Health Care Services, & Institute of Medicine (2009). Initial National Priorities for Comparative Effectiveness Research. Washington, DC: National Academies Press. Retrieved from http://www.nap.edu/catalog.php?record_id=12648 Cohen, A., Stavri, P., & Hersh, W. (2004). A categorization and analysis of the criticisms of evidence-based medicine. International Journal of Medical Informatics, 73, 35–43. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/15036077 Descriptions of methodological details and challenges for EBM. (2007). In Medical Care, 47, Suppl 2(10). Eden, J., Wheatley, B., McNeil, B., & Sox, H. (Eds.). (2008). Knowing what works in health care: A roadmap for the nation. Washington, DC: National Academies Press. Federal Coordinating Council for Comparative Effectiveness Research. (2009). Report to the President and the Congress. Washington, DC: Department of Health and Human Services. Retrieved from http://www.med.upenn.edu/sleepctr/documents/FederalCoordinatingCoucilforCER_2009.pdf Guyatt, G., & Voelker, R. (2015). Everything you ever wanted to know about evidence-based medicine. JAMA, 313(18): 1783–1785. doi:10.1001/jama.2015.2845. Hersch, W. (2009). Information retrieval: A health and biomedical perspective. New York: Springer Verlag. No audio.

Evidence-Based Practice References – Lecture a Continued Hoffmann, T., Montori, V., & Del Mar, C. (2014). The connection between evidence-based medicine and shared decision making. JAMA, 312(13): 1295–1296. doi:10.1001/jama.2014.10186 Institute of Medicine. (2001). Crossing the quality chasm: A new health system for the 21st century. Washington, DC: National Academies Press. Retrieved from http://iom.nationalacademies.org/Reports/2001/Crossing-the-Quality-Chasm-A-New-Health-System-for-the-21st-Century.aspx Johnson, L. B., & Warren, B. E. (2011). Evidence-based practice and health advocacy organizations. JAMA, 306(13): 1443–1445. doi:10.1001/jama.2011.1405 Kida, T. (2006). Don’t believe everything you think: The 6 basic mistakes we make in thinking. Amherst, NY: Prometheus Books. Luce, B., Kramer, J., Goodman, S., Connor, J., Tunis, S., Whicher, D., & Schwartz, J. (2009). Rethinking randomized clinical trials for comparative effectiveness research: the need for transformational change. Annals of Internal Medicine, 151, 206–209. Ohman, E., & Califf, R. (2010). When can noninferior be superior: The multidimensional nature of clinical decision-making calls for innovative approaches to clinical trials. Journal of the American College of Cardiology, 55(6): 555–557 Sheridan, D. J., & Julian, D. G. (2016). Achievements and limitations of evidence-based medicine. Journal of the American College of Cardiology, 68(2), 204-213. Retrieved from http://www.onlinejacc.org/content/68/2/204 Washington, A., & Lipstein, S. (2011). The patient-centered outcomes research institute — Promoting better information, decisions, and health. New England Journal of Medicine, 365, e31. Retrieved from http://www.nejm.org/doi/full/10.1056/NEJMp1109407 No audio. Health IT Workforce Curriculum Version 4.0

The Culture of Health Care Evidence-Based Practice Lecture a This material was developed by Oregon Health & Science University, funded by the Department of Health and Human Services, Office of the National Coordinator for Health Information Technology under Award Number IU24OC000015. This material was updated in 2016 by Bellevue College under Award Number 90WT0002. No audio. Health IT Workforce Curriculum Version 4.0