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The Culture of Healthcare

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1 The Culture of Healthcare
Evidence-Based Practice Welcome to The Culture of Healthcare: Evidence-Based Practice. This is Lecture b. The component, The Culture of Healthcare, addresses job expectations in healthcare settings. It discusses how care is organized within a practice setting, privacy laws, and professional and ethical issues encountered in the workplace. Lecture b This material (Comp2_Unit5b) was developed by Oregon Health and Science University, funded by the Department of Health and Human Services, Office of the National Coordinator for Health Information Technology under Award Number IU24OC

2 Evidence-Based Practice 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) Apply EBM for intervention studies, including the phrasing of answerable questions, finding evidence to answer them, and applying them to given clinical situations (Lecture c) Understand EBM applied to the other key clinical questions of diagnosis, harm, and prognosis (Lectures d, e) Discuss the benefits and limitations to summarizing evidence (Lecture f) Describe how to implement EBM in clinical settings through clinical practice guidelines and decision analysis (Lecture g) By the end of this unit, Evidence-Based Practice, students will be able 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 Apply EBM for intervention studies, including the phrasing of answerable questions, finding evidence to answer them, and applying them to given clinical situations Understand EBM applied to the other key clinical questions of diagnosis, harm, and prognosis Discuss the benefits and limitations to summarizing evidence Describe how to implement EBM in clinical settings through clinical practice guidelines and decision analysis Health IT Workforce Curriculum Version 3.0/Spring 2012 The Culture of Healthcare Evidence-Based Practice Lecture b

3 Making Evidence-Based Clinical Decisions (Mulrow, 1997)
This lecture will present some definitions of and describe the application of evidence-based medicine. This diagram appeared in a paper by Mulrow [muhl-row] et al. in It puts the use of evidence in the proper context. Basically, evidence is one of three aspects of what goes into making a clinical decision. First, we need to know what the research shows, the results of studies such as randomized trials and systematic reviews. But there are other factors that go into making a clinical decision. A second aspect is factors about the patient and/or the physician, such as cultural beliefs, personal values, experience, and education. Patients may have preferences. Physicians may have limitations in the skills that they have, particularly if in rural areas or places where the entire spectrum of medical services is not available. The third aspect of making clinical decisions is constraints. There are formal policies and laws, and community standards. There may also be issues of time; if a patient is acutely ill, there may not be enough time to do what the absolute best evidence would support. Then, of course, there are issues of reimbursement, for example, what will be covered by insurance. 5.1 Figure: Adapted from (Mulrow, Cook, & Davidoff ,1997) Health IT Workforce Curriculum Version 3.0/Spring 2012 The Culture of Healthcare Evidence-Based Practice Lecture b

4 The Culture of Healthcare Evidence-Based Practice Lecture b
Best Resources For EBM Three major books: Straus et al., Evidence-Based Medicine: How to Practice and Teach EBM, Third Edition, 2005 Formerly known as “the Sackett book” Guyatt et al., Users’ Guides to the Medical Literature, 2008 (two books – one a handbook, the other more complete) Web sites There are many resources for evidence-based medicine. Not only do they give good descriptions of how to practice it, but they also demystify a lot of the ideas and techniques behind it. One of these is a book by Straus [strous] et al, formally known as the “Sackett Book”, as it was really the original book in evidence-based medicine authored by David Sackett of McMaster University before he retired. Straus is now the editor of the book, which is in its third edition. There are also two books by Guyatt et al., which includes several authors from McMaster University. These books come from a series of articles published in the Journal of the American Medical Association or JAMA [jam-uh] under the broad heading of “Users Guides to the Medical Literature.” In 2008, the second editions of these two books came out. One of them is a small handbook; the larger is a more encyclopedic reference about evidence-based medicine. There are also plenty of websites about evidence-based medicine, some of which are listed here: Health IT Workforce Curriculum Version 3.0/Spring 2012 The Culture of Healthcare Evidence-Based Practice Lecture b

5 The Changing Nature Of EBM (Hersh, 1999)
Initial approach (aka, “first generation”) was for clinician to find and critically appraise evidence Takes too much time, clinicians lack expertise More recent approach (aka, “next generation”) is synthesis and synopsis of evidence for clinician Access to on-line, up-to-date information makes easier Slawson & Shaughnessy (2005) argue there should be more emphasis on teaching information management (seeking) than the techniques of EBM Evidence-based medicine has been evolving over the years. A paper in 1999 by Hersh observed this trend, referring to the initial approach to evidence-based medicine as first generation EBM. This was the idea that a clinician would actually find and critically appraise evidence as he or she was applying it in the clinical setting. The clinician would go out, find the article, critically appraise it, and then make the clinical decision. It became readily apparent; however, that that process took too much time, especially in the busy clinical setting, and that not all clinicians had the expertise to really understand the study design, the nuances of the statistics, and so forth. The more recent approach, referred to as the next generation of evidence-based medicine, is more the use of synthesis and synopsis of evidence for the clinician, making it more imperative to provide the clinician with on-line, up-to-date information that makes the application of evidence in clinical decisions easier. Slawson takes this a step further, arguing that we should not be discussing the different kinds of evidence and how to critically appraise them, but instead, we should put more emphasis on teaching clinicians better information management, or information seeking skills. Health IT Workforce Curriculum Version 3.0/Spring 2012 The Culture of Healthcare Evidence-Based Practice Lecture b

6 Another Viewpoint Concerning Evidence (Haynes, 1999)
Can it work? Efficacy studies take place under “ideal” circumstances This unit looks mainly at such studies Does it work? Effectiveness studies ascertain whether something works in the “real world” Sometimes called “outcomes research” (Clancy & Eisenberg, 1998) Is it worth it? Cost-benefit or cost-effectiveness studies determine whether benefits worthwhile in relation to cost or other resources Another viewpoint concerning evidence comes from Brian Haynes, whose name you will see throughout this unit. The kinds of questions that we think about when we apply evidence, or when we are assessing either a treatment or a diagnostic test, are: can it work? Does it work? And, Is it worth it? The first question we ask about a study, is, Can it work? These are typically called efficacy studies. These studies take place under ideal conditions, such as a randomized controlled trial. The patients are followed closely with a great deal of data collected about them. Efficacy [ef-i-kuh-see] studies help us determine whether tests or treatments work. Evidence based medicine mostly focuses on those kinds of studies. The next question is, Does it work? These are sometimes called effectiveness studies where we look at whether something works in the real world. This used to go by the name outcomes research, although that name is a little passé now. But the idea is to see if something works when put in the hands of a much larger segment of the clinical provider population. The final question in this framework is, Is it worth it? So we do either cost benefit or cost effectiveness studies to see whether the benefits are worthwhile in relation to the cost of a test or a treatment. Health IT Workforce Curriculum Version 3.0/Spring 2012 The Culture of Healthcare Evidence-Based Practice Lecture b

7 Hierarchy of Evidence – The “4S” Model (Haynes, 2001)
Subsequently updated to “5S” (Haynes, 2005) and “6S” models (DiCenso, 2009), but this one is preferred Another way to look at evidence is to look at the hierarchy of evidence. One approach shows the different types of evidence that clinicians use for decision-making. This model was developed by Haynes and originally started as the “4S” model, the simplest version. He subsequently divided some of the levels into additional levels and updated the model to “5S” and “6S”. But really, the basic 4S model is preferred. The foundation of evidence is studies - original research that is written up in articles, and published in medical journals. However, for many topics, especially common diseases and common treatments, there are many studies, so we need to synthesize them. Thus the next level in the hierarchy is syntheses [sin-thuh-seez]. The best syntheses [sin-thuh-seez] are ones that are called systematic reviews. Also sometimes called evidence reports, they systematically review all of the evidence for a given clinical question. Syntheses, however, can be quite substantial in length and a busy clinician really might want to get to the gist of the evidence. Thus the next level in the hierarchy is synopses, which are sometimes call evidence based abstractions where key points are abstracted from comprehensive syntheses. Finally, the highest level of evidence is systems, where there is actionable knowledge, or knowledge taken from the synopses [si-nop-seez] that can be put into a logical form and used ideally by electronic systems to automatically guide decision-making. 5.2 Figure: adapted from Hayne’s “4S” model of the Hierarchy of Evidence (2001) Health IT Workforce Curriculum Version 3.0/Spring 2012 The Culture of Healthcare Evidence-Based Practice Lecture b

8 Where The Evidence Comes From
Where does the evidence come from? Depending on the level, there are different types of evidence and, in the slides that follow we will discuss a number of these in detail. 5.3 Figure: Adapted from Haynes “S4” model of the Hierarchy of Evidence (2001) with types and sources of evidence Health IT Workforce Curriculum Version 3.0/Spring 2012 The Culture of Healthcare Evidence-Based Practice Lecture b

9 The Culture of Healthcare Evidence-Based Practice Lecture b
Studies Accessed (usually) in literature databases such as MEDLINE Most common and freely available system for accessing medical literature is Pubmed, available at Retrieved from journals Many available electronically now Application of critical appraisal and formulae e.g., relative risk, number needed to treat, sensitivity, odds ratio, etc. Starting at the level of studies, this evidence usually comes from the medical literature, usually by accessing databases such as Medline, a database specific to medicine. Medline can be accessed in many ways, but the most common way, which is freely available, is the Pubmed (pub-med) from the National Library of Medicine. Studies are retrieved from journals, after which we apply critical appraisal and the various formulae that we will go through, such as relative risk, a number to treat, sensitivity, odds ratio, etcetera. Health IT Workforce Curriculum Version 3.0/Spring 2012 The Culture of Healthcare Evidence-Based Practice Lecture b

10 The Culture of Healthcare Evidence-Based Practice Lecture b
Syntheses Systematic reviews Exhaustive review of data on a topic done in a systematic manner Not a simple literature review or overview of papers one knows about Application, where appropriate, of meta-analysis, the combination of results from multiple studies in a single analysis Studies must be appropriately similar, and there are methodological means to assess that Available in Pubmed or in specialized Pubmed Health The next level is syntheses [sin-thuh-seez], which are typically systematic reviews or sometimes evidence reports. These are exhaustive reviews of the data on a given topic and where appropriate, are the application of meta-analysis, which is the combination of results of multiple, similar studies into a single analysis. These studies have to be appropriately similar - there are actually methodologic means to assess whether studies are similar enough. If there have been fifteen different clinical trials looking at surgery or medical treatment for back pain or a specific type of cancer, we can combine those studies. Again they have to be similar enough. They need to have similar interventions, perhaps similar patient groups, and we can then combine them in a meta-analysis. Meta-analysis can be done not only for treatments, but also for diagnostic tests, prognosis, and so forth. Systematic reviews are available in Pubmed (pub-med) or in the specialized Pubmed Health database, which is limited to systematic reviews. Health IT Workforce Curriculum Version 3.0/Spring 2012 The Culture of Healthcare Evidence-Based Practice Lecture b

11 The Culture of Healthcare Evidence-Based Practice Lecture b
Synopses And Systems Synopses – highly summarized information appropriate for clinical setting, e.g., Critically appraised topics (CATs) Clinical Evidence, InfoPOEMS, PIER Clinical practice guidelines Systems – decision support within electronic health records Best way to provide evidence to clinicians at point of decision-making Synopses [si-nop-seez] then are summaries of information that is appropriate for the clinical setting. The synopses [si-nop-seez] provides the answer. After all, we may be in a busy clinical environment with a patient with back pain and we want to know what the evidence shows for this or that treatment. We do not necessarily want to know all of the many different studies that have been done and how they have been combined. And we do not necessarily want the details of individual studies because, for many topics, there have been many studies and it would be inappropriate to only focus on one. Synopses are available in things like critically appraised topics, or CATs [katz] as they are sometimes called. There are publications such as the book Clinical Evidence. InfoPOEMs is another resource as is PIER [peer], which we will talk about when we discuss synopses [si-nop-seez] in more detail. Clinical practice guidelines also fall into this synopses category. The highest level in the hierarchy is systems, which are decision support systems within electronic health records. They are probably the best way to actually provide evidence to clinicians where they are actually making decisions. This is the highest level of knowing the context of patient care and providing the evidence to the clinician to use in providing clinical care. Health IT Workforce Curriculum Version 3.0/Spring 2012 The Culture of Healthcare Evidence-Based Practice Lecture b

12 Overview Of The Application Of EBM
Steps include Phrasing a clinical question that is pertinent and answerable Identifying evidence to address the question Critically appraising the evidence to determine if it applies to the patient How is evidence based medicine applied? The steps are listed on this slide. The first step is phrasing a clinical question that is pertinent and answerable. The second step is identifying the evidence to address the question. The third step is critically appraising the evidence to determine if it applies to the patient. We will spend less time discussing critical appraisal, although we will go into more detail on it when we talk about interventions; however, all of the references listed several slides back describe the process of critically appraising the evidence. Health IT Workforce Curriculum Version 3.0/Spring 2012 The Culture of Healthcare Evidence-Based Practice Lecture b

13 Phrasing The Clinical Question
Background vs. foreground questions Background questions ask for general knowledge about a disorder Usually answered with textbooks and classical review articles Foreground questions ask for knowledge about managing patients with a disorder Usually answered using EBM techniques The next few slides discuss phrasing the clinical question. One way to view clinical questions is to distinguish between background and foreground questions. Background questions are general kinds of questions that come up in the care of patients and these are usually answered without using evidence-based medicine techniques. We look them up in a textbook or perhaps seek out a more classic review article that is not something like the systematic review. Foreground questions are when we ask for knowledge about managing patients with specific disorders and were contemplating a test or a treatment - these are the questions that are usually answered with evidence based medicine techniques. Health IT Workforce Curriculum Version 3.0/Spring 2012 The Culture of Healthcare Evidence-Based Practice Lecture b

14 The Culture of Healthcare Evidence-Based Practice Lecture b
Background Questions General information not specific to a given patient Examples What causes pneumonia? When do complications of diabetes usually occur? Distinction from foreground questions can be blurry New etiologies of disease Level of training, e.g., specialist vs. student Let’s explore this further. Sometimes background questions ask for general information that is not specific to a given patient, such as, What causes pneumonia? What are the types of things that usually cause pneumonia, such as bacteria, viruses, sometimes chemical pneumonia, and other things. Another example question is, When do the complications of diabetes usually occur? How long does one have the disease before you start to see kidney problems, heart problems, etcetera? It turns out that the distinction from foreground questions is a little bit blurry. It is not quite as distinct as one might hope. For example, there are new etiologies or causes of disease that we may want to know. It also depends some on your level of training. If you are a sub-specialist, something may be more of a background question, as opposed to when you are a student, when nearly everything is new and all questions tend to be foreground questions. Though the distinction is blurry it is important to understand a clinical question and phrasing a clinical question to find the best evidence. This brings us to foreground questions. Health IT Workforce Curriculum Version 3.0/Spring 2012 The Culture of Healthcare Evidence-Based Practice Lecture b

15 The Culture of Healthcare Evidence-Based Practice Lecture b
Foreground Questions Have three or four essential components (PICO) Patient and/or problem Intervention Comparison intervention (if appropriate) Outcomes Example In an elderly patient with congestive heart failure, are beta blockers helpful in reducing morbidity and mortality without excess side effects? Foreground questions have three or four essential components. One way to remember these components is the PICO [pee-koh] acronym. A complete foreground question has a patient and/or a problem. There is also an intervention. It may be a treatment or a diagnostic test. There is a comparison intervention if appropriate. And then there is some sort of outcome. If it is a treatment question, there is a patient with a disease and administration of a specific treatment. If we are looking for evidence, we try to do a randomized control trial that compares that treatment with a control or a placebo group. Finally, there is some kind of outcome. Either the treatment is more effective or less effective than the control or placebo. With a diagnostic test, we may look at how accurate the test is, so that we are comparing against some sort of gold standard. With something like prognosis, how patients do, we may not necessarily have a comparison – instead we just follow the natural history of a disease. Here is an example of a foreground question: In an elderly patient with congestive heart failure where the heart is not pumping as strongly as it could, are beta blockers, which are a type of drug, helpful in reducing morbidity and mortality without excess side effects? Health IT Workforce Curriculum Version 3.0/Spring 2012 The Culture of Healthcare Evidence-Based Practice Lecture b

16 Four categories of foreground questions
Intervention (or Therapy) – benefit of treatment or prevention Diagnosis – test diagnosing disease Harm – etiology or cause of disease Prognosis – outcome of disease course There are four major categories of foreground questions and most clinical questions fall into these buckets. The first category is called an intervention, although many textbooks call it therapy. This category looks at the benefit of an intervention, such as treatment or prevention of disease. Diagnosis is when we look at some way of diagnosing disease, typically with a test. The tests we commonly think of are blood tests, but any type of maneuver on a physical examination is also a diagnostic test, as is an x-ray. Often we want to know what caused a disease, which is sometimes called the etiology of the disease – in the evidence based-medicine category this is usually called harm. What causes harm to a patient? Sometimes harm is caused to a patient in the form of an intervention and we may do studies to look at that. And then finally, the last question category is prognosis. What is the outcome of the disease course? Health IT Workforce Curriculum Version 3.0/Spring 2012 The Culture of Healthcare Evidence-Based Practice Lecture b

17 Questions To Ask About The Results From Any Study
Are the results valid? Are the results important? Can the results be applied to patient care? Specific sub-questions depend on type of question and study When we find a piece of evidence, a study, we ask three questions: are the results of the study valid, are the results important, that is, did the result show that some treatment or test is efficacious [ef-i-key-shuhs], and then can the results be applied to patient care? We also have to determine if the results from a study can be applied to a specific patient. If the study was done with a different age group or a different gender, the results may or may not be applicable. There are many sub questions within these three broad categories that we ask that depend on the type of question, such as whether it is an intervention or diagnosis or harm question, and then we also may ask different questions based on the type of study that we have. We may have a systematic review or we may have a randomized controlled trial. In the next few lectures we will look at the different types of clinical questions, how we look at studies and how we look at evidence or answering those questions. Health IT Workforce Curriculum Version 3.0/Spring 2012 The Culture of Healthcare Evidence-Based Practice Lecture b

18 Evidence-Based Practice Summary – Lecture b
There are many easily accessible resources for EBM Approach has changed over the years Can be best viewed from the 4S model demonstrating the hierarchy of evidence, based on a foundation of studies, brought together where possible by syntheses, summarized in synopses, and implemented in systems that make it actionable When seeking evidence, it is critical to appropriately phrase the clinical question This concludes Lecture (b) of Evidence-Based Practice. In summary, there are many easily accessible resources for EBM. The approach has changed over the years, and can be best viewed from the 4S model demonstrating the hierarchy of evidence, based on a foundation of studies, brought together where possible by syntheses, summarized in synopses, and implemented in systems that make it actionable. When seeking evidence, it is critical to appropriately phrase the clinical question. Health IT Workforce Curriculum Version 3.0/Spring 2012 The Culture of Healthcare Evidence-Based Practice Lecture b

19 Evidence-Based Practice References – Lecture b
Centre for Evidence Based Medicine - Homepage. (n.d.). Retrieved December 14, 2011, from Centre for Evidence Based Medicine website: Centre for Evidence-Based Medicine, Toronto - Homepage. (n.d.). Retrieved December 14, 2011, from KT Clearninghouse website: Centre for Health Evidence - Homepage. (n.d.). Retrieved December 14, 2011, from Centre for Health Evidence website: Clancy, C., & Eisenberg, J. (1998). Outcomes research: measuring the end results of health care. Science, 282, DiCenso, A., Bayley, L., & Haynes, R. (2009). ACP Journal Club. Editorial: Accessing preappraised evidence: fine-tuning the 5S model into a 6S model. Annals of Internal Medicine, 151(6), JC3-2, JC3-3. Evidence Based Medicine. (2009, November 11). Retrieved December 14, 2011, from Netting the Evidence - Blog website: Guyatt, G., Rennie, D., Meade, M., & Cook, D. (2008a). Users' Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice. New York, NY: McGraw-Hill. Guyatt, G., Rennie, D., Meade, M., & Cook, D. (2008b). Users' Guides to the Medical Literature: Essentials of Evidence-Based Clinical Practice. New York, NY: McGraw-Hill. Haynes, R. (1999). Can it work? Does it work? Is it worth it? British Medical Journal, 319, Haynes, R. (2001). Of studies, syntheses, synopses, and systems: the "4S" evolution of services for finding current best evidence. ACP Journal Club, 134, A11-A13. Haynes, R. (2006). Of studies, syntheses, synopses, summaries, and systems: the "5S" evolution of information services for evidence-based healthcare decisions. Evidence-Based Medicine, 11, No Audio Health IT Workforce Curriculum Version 3.0/Spring 2012 The Culture of Healthcare Evidence-Based Practice Lecture b

20 Evidence-Based Practice References – Lecture b (continued)
Reference (continued) Hersh, W. (1999). "A world of knowledge at your fingertips": the promise, reality, and future directions of on-line information retrieval. Academic Medicine, 74, Mulrow, C., Cook, D., & Davidoff, F. (1997). Systematic reviews: critical links in the great chain of evidence. Annals of Internal Medicine, 126, PubMed Health Homepage. (n.d.). Retrieved December 14, 2011, from US National Library of Medicine website: PubMed Homepage. (n.d.). Retrieved December 14, 2011, from National Institutes of Health - US National Library of Medicine website: Slawson, D., & Shaughnessy, A. (2005). Teaching evidence-based medicine: should we be teaching information management instead? Academic Medicine, 80, Straus, S., Richardson, W., Glasziou, P., & Haynes, R. (2005). Evidence Based Medicine: How to Practice and Teach EBM, Third Edition. New York, NY: Churchill Livingstone. No Audio Charts, Tables, Figures 5.1 Figure: Adapted from Mulrow, 1997) Mulrow, C., Cook, D., & Davidoff, F. (1997). Systematic reviews: critical links in the great chain of evidence. Annals of Internal Medicine, 126, 5.2 Figure: Adapted from Hayne’s “4S” model of the Hierarchy of Evidence: Haynes, R. (2001). Of studies, syntheses, synopses, and systems: the "4S" evolution of services for finding current best evidence. ACP Journal Club, 134, A11-A13. 5.3 Figure: Adapted from Hayne’s “4S” model of the Hierarchy of Evidence with types and sources of evidence: Haynes, R. (2001) Of studies, syntheses, synopses, and systems: the "4S" evolution of services for finding current best evidence. ACP Journal Club, 134, A11-A13. Health IT Workforce Curriculum Version 3.0/Spring 2012 The Culture of Healthcare Evidence-Based Practice Lecture b


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