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Pierre Simon Laplace (1814) put forward the idea that essentially all knowledge was uncertain and generic etodolac 200mg fast delivery, therefore order 300mg etodolac overnight delivery, probabilistic in nature purchase 400 mg etodolac free shipping. The work of Pierre Charles Alexandre Louis on typhoid and diphtheria (1838) debunking the theory of bleeding used probabilistic principles. On the other side was Francois Double, who felt that treatment of the individual was more important than knowing what happens to groups of patients. The art of medicine was defined as deductions from experience and induction from phys- iologic mechanisms. The rise of modern biomedical research Most research done before the twentieth century was more anecdotal than sys- tematic, consisting of descriptions of patients or pathological findings. James Lind, a Royal Navy surgeon, carried out the first recorded clinical trial in 1747. In looking for a cure for scurvy, he fed sailors afflicted with scurvy six different treatments and determined that a factor in limes and oranges cured the disease while other foods did not. His study was not blinded, but as a result, 40 years later limes were stocked on all ships of the Royal Navy, and scurvy among sailors became a problem of the past. Research studies of physiology and other basic science research topics began to appear in large numbers in the nineteenth century. By the start of the twenti- eth century, medicine had moved from the empirical observation of cases to the scientific application of basic sciences to determine the best therapies and cat- alog diagnoses. Although there were some epidemiological studies that looked at populations, it was uncommon to have any kind of longitudinal study of large 8 Essential Evidence-Based Medicine groups of patients. There was a 200-year gap from Lind’s studies before the con- trolled clinical trial became the standard study for new medical innovations. It was only in the 1950s that the randomized clinical trial became the standard for excellent research. Beginning in the early 1900s, he developed the basis for most the- ories of modern statistical testing. Austin Bradford Hill was another statistician, who, in 1937, published a series of articles in the Lancet on the use of statisti- cal methodology in medical research. In 1947, he published a simple commen- tary in the British Medical Journal calling for the introduction of statistics in the medical curriculum. He showed that streptomycin therapy was superior to standard therapy for the treatment of pulmonary tuberculosis. Finally, Archie Cochrane was particularly important in the development of the current movement to perform systematic reviews of medical topics. He was a British general practitioner who did a lot of epidemiological work on respira- tory diseases. In the late 1970s, he published an epic work on the evidence for medical therapies in perinatal care. This was the first quality-rated systematic review of the literature on a particular topic in medicine. As Santayana said, it is important to learn from history so as not to repeat the mistakes that civilization has made in the past. The improper application of tainted evidence has resulted in poor medicine and increased cost without improving on human suffering. This book will give physicians the tools to evalu- ate the medical literature and pave the way for improved health for all. In the next chapter, we will begin where we left off in our history of medicine and statistics and enter the current era of evidence-based medicine. The most savage controversies are those about matters as to which there is no good evidence either way. Bertrand Russell (1872–1970) Learning objectives In this chapter, you will learn: r why you need to study evidence-based medicine r the elements of evidence-based medicine r how a good clinical question is constructed The importance of evidence In the 1980s, there were several studies looking at the utilization of various surg- eries in the northeastern United States. These studies showed that there were large variations in the amount of care delivered to similar populations. They found variations in rates of prostate surgery and hysterectomy of up to 300% between similar counties. The researchers concluded that physicians were using very different standards to decide which patients required surgery. Both clinicians and policy makers need to know whether the 9 10 Essential Evidence-Based Medicine Fig. Patient values conclusions of a systematic review are valid, and whether recommendations in practice guidelines are sound. This is a paradigm shift that represents both a breakdown of the traditional hierarchical system of medical practice and the acceptance of the scientific method as the governing force in advancing the field of medicine. Evidence-based medicine can be seen as a combination of three skills by which practitioners become aware of, critically analyze, and then apply the best avail- able evidence from the medical research literature for the care of individual patients. This set of skills will help you to develop critical thinking about the content of the medical literature. The application of research results is a blend of the available evidence, the patient’s preferences, the clinical situation, and the practitioner’s clinical experience (Fig. In response to the high variability of medical practice and increasing costs and complexity of medical care, systems were needed to define the best and, if pos- sible, the cheapest treatments. Individuals trained in both clinical medicine and epidemiology collaborated to develop strategies to assist in the critical appraisal of clinical data from the biomedical journals. In the past, a physician faced with a clinical predicament would turn to an expert physician for the definitive answer to the problem. This could take the form of an informal discussion on rounds with the senior attending (or consul- tant) physician, or the referral of a patient to a specialist. The answer would come from the more experienced and usually older physician, and would be taken at face value by the younger and more inexperienced physician. That clinical answer was usually based upon the many years of experience of the older physi- cian, but was not necessarily ever empirically tested.

The authors purchase etodolac 200mg online, editors etodolac 400mg free shipping, and publishers therefore disclaim all liability for direct or consequential damages resulting from the use of material contained in this publication order etodolac 400 mg mastercard. Readers are strongly advised to pay careful attention to information provided by the manufacturer of any drugs or equipment that they plan to use. However, the publisher has no responsibility for the websites and can make no guarantee that a site will remain live or that the content is or will remain appropriate. Kaplan v vi Contents 17 Applicability and strength of evidence 187 18 Communicating evidence to patients 199 Laura J. Henry Pohl, then Associate Dean for Aca- demic Affairs, asked me to develop a course to teach students how to become lifelong learners and how the health-care system works. The first syllabus was based on a course in critical appraisal of the medical literature intended for inter- nal medicine residents at Michigan State University. The basis for the orga- nization of the book lies in the concept of the educational prescription proposed by W. The goal of the text is to allow the reader, whether medical student, resident, allied health-care provider, or practicing physician, to become a critical con- sumer of the medical literature. This textbook will teach you to read between the lines in a research study and apply that information to your patients. For reasons I do not clearly understand, many physicians are “allergic” to mathematics. It seems that even the simplest mathematical calculations drive them to distraction. Although the math content in this book is on a pretty basic level, most daily interaction with patients involves some understanding of mathematical processes. We may want to determine how much better the patient sitting in our office will do with a particular drug, or how to interpret a patient’s concern about a new finding on their yearly physical. Far more commonly, we may need to interpret the information from the Internet that our patient brought in. The math is limited to simple arithmetic, and a handheld calculator is the only computing ix x Preface instrument that is needed. The layout of the book is an attempt to follow the process outlined in the edu- cational prescription. You will be given information about the answer after pressing “submit” if you get the question wrong. When you press “submit,” you will be shown the correct or suggested answer for that question and can proceed to the next question. After finishing, a sample of correct and acceptable answers will be shown for you to compare with your answers. Decisions are made by language and the language includes both words and numbers, but before evidence-based decision-making came along, relatively little consideration was given to the types of statement or proposi- tion being made. Hospital Boards and Chief Executives, managers and clinicians, made statements but it was never clear what type of statement they were mak- ing. Was it, for example, a proposition based on evidence, or was it a proposition based on experience, or a proposition based on values? All these different types of propositions are valid but to a different degree of validity. This language was hard-packed like Arctic ice, and the criteria of evidence- based decision-making smash into this hard-packed ice like an icebreaker with, on one side propositions based on evidence and, on another, propositions based on experience and values. As with icebreakers, the channel may close up when the icebreaker has moved through but usually it stays open long enough for a decision to be made. We use a simple arrows diagram to illustrate the different components of a decision, each of which is valid but has a different type of validity. Evidence-based decision-making is what it says on the tin – it is evidence-based – but it needs to take into account the needs and values of a particular patient, service or population, and this book describes very well how to do that. Foremost, I want to thank my wife, Julia Eddy, without whose insight this book would never have been written and revised. Her encourage- ment and suggestions at every stage during the development of the course, writ- ing the syllabi, and finally putting them into book form, were the vital link in creating this work. At the University of Vermont, she learned how statistics could be used to develop and evaluate research in psychology and how it should be taught as an applied science. She encouraged me to use the “scientific method approach” to teach medicine to my students, evaluating new research using applied statistics to improve the practice of medicine. This group of committed students and faculty has met monthly since 1993 to make constructive changes in the course. Their suggestions have been incorporated into the book, and this invaluable input has helped me develop it from a rudi- mentary and disconnected series of lectures and workshops to what I hope is a fully integrated educational text. I am indebted to the staff of the Office of Medical Education of the Department of Internal Medicine at the Michigan State University for the syllabus material that I purchased from them in 1993. I think they had a great idea on how to intro- duce the uninitiated to critical appraisal. I would especially like to thank the following faculty and students at Albany Medical College for their review of the manuscript: John Kaplan, Ph. Their edi- torial work over the past several years has helped me refine the ideas in this book. I would also like to thank Chase Echausier, Rachael Levet, and Brian Leneghan for their persistence in putting up with my foibles in the production of the manuscript, and my assistant, Line Callahan, for her Herculean effort in typing the manuscript. I owe a great debt to the staff at the Cambridge University Press for having the faith to publish this book.

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Elicit the patient’s concerns and listen without interrupt- diagnosis brief and the discharge planning suboptimal order etodolac 300 mg without a prescription. As with other patients discount etodolac 200 mg amex, the most important The resident remembered the encounter and indicated concern may only be brought up after the third concern that generic 400mg etodolac free shipping, since the patient was a physician, the resident did is presented. Don’t assume that physician patients need less explana- recommendations as with other patients. Remember that a physician’s knowledge of therapeutics in an area of practice not his or her own Introduction quickly become dated after medical school. Intellectualizing for your own self-comfort or being drawn helping doctors,” or “extending professional courtesy,” caring into talking shop is not in the best service of your pa- for colleagues is an important tradition in medicine. They may quoted maxim that “The physician who treats himself has a have specifc ideas or concerns that are not shared by other fool for a patient. What does it mean to “immi- Within our current medical culture there is clear endorsement grate to the nation of the sick? For • Physicians should have a family physician and an age- example, not all physicians are fnancially sound or have appropriate health assessment as an occupational overhead and/or disability insurance. Thoroughness, including a complete physical examination, • Physicians should not self-medicate through self- cannot be sacrifced. Physicians are observant and expect prescribing, the sample cupboard or workplace supplies. It provides comfort and trust in the physician– Robert Klitzman has invited physicians to be aware of “post- patient relationship. The demonstration of empathy is as important as in other and denying symptoms, worrying too little, self-diagnosing and physician–patient relationships. Physicians worry about the transforma- colleagues we need to be aware of our own reactions. At times, particularly if they our physician patient’s response to illness close to home? The end of the visit should involve more than education, Case resolution involvement in decision-making and enquiring whether The program director reviewed some of the key prin- your patient got what they needed. As treating physicians ciples involved in treating colleagues and the importance we need to be clear and explicit about our practice with of maintaining appropriate roles and boundaries in such regard to prescriptions, consultations and investigations. The resident acknowledged being irritable, not download the physician roles and responsibilities to fatigued and hungry that evening after being on call your physician patient. We all deserve confdentiality and privacy in our health ing in the emergency room for a second opinion refused. However, we may also need to refect with our physi- The resident and program director discussed a mutually cian patient on how privacy issues or maintaining secrets agreeable approach to address the complaint. This may be especially relevant when physician patients the frustration, fear, and disappointment the patient had are suffering from diseases of degeneration (including experienced. As a result, the resident gained a deeper aging), psychiatric illness or substance use disorders. We must be aware that illness is not unprofessional conduct and that there is a difference between illness and impairment. Physicians for physicians: when doctors be- treatment are as effective for physicians as they are for come patients. In caring for our colleagues we would do well to remember the words of Rabia Elizabeth Roberts: “We learn that our human- ity is more powerful than our expertise alone” (Hanlon 2008). Richard Gunderman would invite us to adopt our part of the highway and to care for one another as colleagues the best way we can. By practising the best kind of philanthropy; the result will beneft the health of all our patients. If a physician is diagnosed with a reportable condi- tory agency, tion, the treating physician is required to report the case to the • outline the consequences of a failure to report, and individual or offce designated in the legislation. Residents who • identify sources of support to guide decision-making in are being treated for serious health issues must also consider this area. A number of colleges include questions Case on licence applications or renewal forms pertaining to alcohol A third-year resident involved in treating a surgeon in or drug dependence and any physical or mental conditions Manitoba is aware that the surgeon suffers from alcohol that might affect ftness to practise. The resident suggests that the surgeon not per- more information in these circumstances. The surgeon continues to practise medicine, Reporting a physician who is not a patient but has assured the resident that they do not drink or take Residents may also have an ethical and legal duty to report a drugs before performing surgeries. What are the resident’s colleague to their governing college in certain circumstances, obligations in the circumstances? Introduction Most statutes and policies require the reporting physician to Reporting another physician to a medical regulatory authority have reasonable grounds for reporting. Terms such as incom- (college) or public health offcial can be diffcult and stressful, petence, incapacity or unft are commonly used in this context particularly for postgraduate trainees or those who supervise but are not typically defned in the pertinent statute or policy them. Some jurisdictions have adopted specifc reporting require- ments for certain conduct issues, such as suspected sexual Residents may become aware of these concerns in the course impropriety by another physician toward a patient. Such an of treating other physicians or through day-to-day contact with obligation most often arises when the physician has reason- colleagues. This section is intended to help residents cope with able grounds, based on information obtained in their medical the stress that arises from uncertainty about their obligations practice, to believe that another physician (whether a patient to report impairment in their colleagues. Some colleges have also adopted policies imposing mandatory reporting ob- Reporting a physician who is your patient ligations in such cases. Various provinces and territories have conduct by other physicians, including so-called disruptive be- also enacted legislation that legally requires physicians to report haviour, to an appropriate authority in the institution, often the a colleague to their governing college in circumstances when chief of the department. Physicians may also have a duty to health issues render the physician patient unft to practise.

Four other prospective studies did not fnd any sig- factors (severity of illness generic etodolac 400 mg fast delivery, surgical vs order etodolac 200mg on-line. Two in the environments in which these protocols were developed studies reported a signifcant improvement in goal achievement and tested discount etodolac 300 mg with amex. Alternatively, some protocols may be more effec- with continuous methods (367, 369) regarding fuid balance tive than others, conclusion supported by the wide variability management. In summary, the evidence is insuffcient to draw in hypoglycemia rates reported with protocols (128, 326–333). None of these trials was conducted specif- Several studies have suggested that computer-based algorithms cally in patients with sepsis. Although the weight of evidence result in tighter glycemic control with a reduced risk of hypo- suggests that higher doses of renal replacement may be associ- glycemia (355, 356). Further study of validated, safe, and effec- ated with improved outcomes, these results may not be general- tive protocols for controlling blood glucose concentrations and izable. Two large multicenter randomized trials comparing the variability in the severe sepsis population is needed. We suggest that continuous renal replacement therapies and Study in Australia and New Zealand) failed to show beneft of intermittent hemodialysis are equivalent in patients with more aggressive renal replacement dosing. We recommend against the use of sodium bicarbonate ther- general populations of acutely ill patients (381–389). The need to extrapolate from general, acutely ill patients evidence supports the use of bicarbonate therapy in the treat- to critically ill patients to septic patients downgrades the ment of hypoperfusion-induced lactic acidemia associated with evidence. Because the patient’s risk of administration is reveal any difference in hemodynamic variables or vasopressor small, the gravity of not administering may be great, and the requirements (378, 379). Bicarbonate administration has been Deciding how to provide prophylaxis is decidedly more associated with sodium and fuid overload, an increase in lac- diffcult. We suggest that patients with severe sepsis be treated with but twice daily dosing produced less bleeding (393). Both criti- a combination of pharmacologic therapy and intermit- cally ill and septic patients were included in these analyses, but tent pneumatic compression devices whenever possible their numbers are unclear. It is logical that patients with severe sepsis would rior to twice daily administration in sepsis. None of the patients consider signifcant even in the absence of proven mortality had bio-accumulation (trough anti-factor Xa level lower than beneft (409–411). Further, bleeding did not correlate with detectable Digital Content 7 and 8 [http://links. Therefore, we recommend that dalteparin A615], Summary of Evidence Tables for effects of treatments can be administered to critically ill patients with acute renal on specifc outcomes. Consequently, considered (as did the authors of the meta-analysis) (411) the these forms should probably be avoided or, if used, anti-factor possibility of less beneft and more harm in prophylaxis among Xa levels should be monitored (grade 2C). The Mechanical methods (intermittent compression devices and balance of benefts and risks may thus depend on the individual graduated compression stockings) are recommended when patient’s characteristics as well as on the local epidemiology of anticoagulation is contraindicated (395–397). Patients should be periodically not focus on sepsis or critically ill patients but included stud- evaluated for the continued need for prophylaxis. We suggest administering oral or enteral (if necessary) feed- us to recommend combination therapy in most cases. Patients receiving heparin should be monitored for after a diagnosis of severe sepsis/septic shock (grade 2C). We suggest avoiding mandatory full caloric feeding in the recommendations are consistent with those developed by the frst week, but rather suggest low-dose feeding (eg, up to American College of Chest Physicians (402). We recommend that stress ulcer prophylaxis using H2 blocker days after a diagnosis of severe sepsis/septic shock (grade 2B). We suggest using nutrition with no specifc immunomodulat- sepsis/septic shock who have bleeding risk factors (grade 1B). When stress ulcer prophylaxis is used, we suggest the use of proton pump inhibitors rather than H receptor antagonists Rationale. We suggest that patients without risk factors should not translocation and organ dysfunction, but also concerning is the receive prophylaxis (grade 2B). This beneft should be appli- and none was individually powered for mortality, with very cable to patients with severe sepsis and septic shock. In fact, there is a suggestion that No evidence of harm was demonstrated in any of those studies. Immune system function can be modifed through altera- Studies comparing full caloric early enteral feeding to lower tions in the supply of certain nutrients, such as arginine, gluta- targets in the critically ill have produced inconclusive results. Numerous studies have assessed In four studies, no effect on mortality was seen (431–434); one whether use of these agents as nutritional supplements can reported fewer infectious complications (431), and the others affect the course of critical illness, but few specifcally addressed reported increased diarrhea and gastric residuals (433, 434) their early use in sepsis. Four meta-analyses evaluated immune- and increased incidence of infectious complications with full enhancing nutrition and found no difference in mortality, nei- caloric feeding (432). In another study, mortality was greater ther in surgical nor medical patients (445–448). However, they with higher feeding, but differences in feeding strategies were analyzed all studies together, regardless of the immunocompo- modest and the sample size was small (435). Underfeeding/trophic feeding strategies did not exclude regulation, and enhanced production of superoxide and advancing diet as tolerated in those who improved quickly. However, arginine supplementation could lead Some form of parenteral nutrition has been compared to to unwanted vasodilation and hypotension (452, 453). Human alternative feeding strategies (eg, fasting or enteral nutrition) trials of l-arginine supplementation have generally been small in well over 50 studies, although only one exclusively studied and reported variable effects on mortality (454–457). The sepsis (436), and eight meta-analyses have been published only study in septic patients showed improved survival, but (429, 437–443). Some authors found improvement (429, 439–443), two of which attempted to explore the effect in secondary outcomes in septic patients, such as reduced of early enteral nutrition (441, 442).

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