STRATEGIC PLANNING FOR EVIDENCE-BASED MEDICINE

1 Evidence-Based Medicine 2 Evidence-Based Medicine 3 Evidence-Based Medicine EVIDENCE-BASED MEDICINE Introduction Evidence-based medicine (EBM) is a relatively new approach to the teaching and practice of medicine. Historically, physicians clinical decision-making was based on the knowledge received during their medical training and experiences gained through individual patient encounters i.e. opinion-based. Evolution of epidemiology, and subsequently clinical epidemiology, resulted in methods that allowed the objective critique of therapies used in clinical practice. Epidemiologic principles were applied to problems encountered in clinical medicine and an increasing number of clinical trials and medical journals emerged. The past two decades have witnessed an acceleration of the information explosion and with it the volume of medical publications. Clinicians faced the difficult task of keeping track of a large amount of new and potentially important information. On the other hand the Continuing Medical Education (CME) as a means of keeping physicians up-to-date was growing, moving from lectures by experts to small group learning, tutorials and interactive feedback sessions. However studies have shown that CME had limited impact on modifying physician performance. A legitimate concern is that many physicians will fail to recognize new and 4 Evidence-Based Medicine necessary changes in practice and patient care will suffer as doctors become outdated and their performance deteriorates over time. Multicentered, randomized trials now make it possible to answer fundamental questions about common medical interventions. The practice of evidence-based medicine requires an understanding of clinical epidemiology, as well as excellent communication skills, patience, and a commitment to provide the patient with the knowledge required to make informed choices. It is important that physicians become familiar with the meaning of EBM and its role in influencing the provision of care and use of health resources. What is Evidence-Based Medicine? Evidence-based medicine has been defined as the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The concept of evidence-based medicine is defined as the integration of individual clinical expertise with the best available clinical evidence from systematic research. Process EBM is the proves of systematically reviewing, appraising and using clinical research findings to aid the delivery of optimum clinical care to patients. Simply put, it means applying the best information to manage patient problems, diagnosis, 5 Evidence-Based Medicine prognosis, harm, patient safety etc . It is based on the assumption that: 1) medical literature, and thus useful information about patient care, is growing at an alarming rate; and 2) in order to provide best care for patients, doctors must be able to continuously upgrade their knowledge, i.e. by accessing, interpreting and using medical literature in a timely fashion. What is the problem? Why is there a need for EBM? Dont we already practice medicine fairly uniformly based on a common fund of evidence?. Bottom line: we are now often practicing medicine based on clinical judgment that is not well informed by the best evidence of medical research a slippery slope to diminished effectivity and/or compromised competence. Why evidence-based medicine? The first reaction of any doctor to EBM is likely to be Well, of course thats what I always do. The second response, perhaps more thoughtful and certainly more honest, will be a degree of confusion: What does it really mean? How does one actually do evidence based medicine? Surely there is not enough time? What kind of doctor am I if my medicine is not evidence based? Some doctors perceived EBM as diminishing the role of clinical acumen and experience, fearing that the art of decision-making will be lost. It should be noted that EBM neither excludes the vital role played by experience, nor advocates the replacement of sound clinical judgment. The practice of EBM 6 Evidence-Based Medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. EBM respects clinical skills while emphasizing the need to develop new skills in information management. The physician of the new millennium, whether specialist or generalist, requires a basic understanding of research methodology to go along with practical strategies for seeking out, assessing and applying the most useful information in concert with patients preferences. Although we need this new evidence daily, we usually fail to get it, because we dont get the evidence, both our up-to-date knowledge and our clinical performance deteriorate with time. Trying to overcome clinical entropy through traditional CME programs doesnt improve our clinical performance. A different approach to clinical learning has been shown to be effective in keeping practitioners up to date: EBM The premise of EBM is a simple one, that excellence in patient care correlates with the use of the best currently available evidence, and that physicians require a unique set of skills which are not part of traditional medical education, in order to access and utilize this information. The powerful tools employed in EBM are Randomized Control Trials (RCT) in which, for example, two groups to be studied are carefully matched in such a way that any significant difference between them will occur only by chance; and Meta-analysis which is a process of merging data of similar smaller studies to obtain the power of a larger study which can assist in drawing firmer 7 Evidence-Based Medicine conclusions. This indeed, is the simplified rationale for evidence-based medicine. Sometimes research findings may contradict each other and obscure the true picture this is particularly the case with small trials. However, by pooling together all the results of various research studies, the sample size can, in effect, be increased. This is known as meta-analysis. Although pooling together the results of a number of trials will provide a greater weight of evidence, it is still important to examine meta-analyses critically:- Was a broad enough search strategy used? MEDLINE, for instance, covers only about a quarter of the worlds biomedical journals. Do the results all or mostly point in the same direction? A meta-analysis should not be used to produce a positive result by averaging the results of, say, five trials with negative and ten trials with positive findings. Are the trials in the meta-analysis all small trials? If so, be very cautious. The process of EBM EBM is a rapidly changing and complex field driven by information technology. There are five broad domains to be considered in EBM process: 1. Asking answerable questions. 2. Searching for the best evidence. 3. Critically appraising the evidence. 8 Evidence-Based Medicine 4. Applying the evidence to individual patient care, and, 5. Evaluating the process. Asking answerable questions The practicing physician is always faced with the dilemma of how best to answer the clinical questions either arising, for example, from failure of therapy or from the inquisitive patient. By extension questions could also come from diverse areas that have stake in health care delivery. In order to be able to search for evidence regarding a particular clinical issue, a proper answerable question must be formulated. This is not always as easy as it may seem. It can be done by making sure the question contains four areas abbreviated by the acronym PICO. P stands for the description of patient or population; I for the intervention, C for the comparison group; O for the outcome. Searching for the best evidence Medical books per se are still useful sources of medical information. But considering the time lapse between writing a book and the book hitting the stand, may be five years in some cases- by which time some information might have become obsolete, books cannot be considered as the best source of evidence. They are good for teaching purposes reference to a limited extent and it needs update regularly. 9 Evidence-Based Medicine In order to obtain the best evidence, an electronic-based search of answers to the formulated questions in sources of ready made evidence, is the easiest and fastest way. These sources include the Cochrane Library, Best Evidence, ACP Journal Club, Clinical Evidence; Infopoems, DARE and others. The main obstacle against using these resources is cost of subscription (that they are not free). If these sources are not available or if the answers of the search question was not found in them, one would have to search sources of primary evidence (original articles and systematic reviews). These articles can be found in electronic databases (e.g. Medline, EMBASE, SAM) and Electronic journals (e.g. Bandolier, Journal of Evidence Based medicine, JAMA, NEJM, Lancet, BMJ etc.) Critically appraising the evidence The practitioner needs to develop a sorting strategy in reviewing the available literature so as to remove relevant from irrelevant materials. Then he should decide whether the article is well conducted and can be used or not. Several checklists have been developed to help make this process easy, systematic and more or less reproducible. Usually they focus on three man areas; validity, results and applicability. Validity or closeness to truth usually examines the methodology of the article 10 Evidence-Based Medicine Critical appraisal For any clinician, the real key to assessing the usefulness of a clinical study and interpreting the results to an area of work is through the process of critical appraisal. This is a method of assessing and interpreting the evidence by systematically considering its validity, results and relevance to the area of work considered. The Critical Appraisal Skills helps health service professionals and decision-makers develop skills in appraising evidence about clinical effectiveness. Its process uses three broad issues that should be considered when appraising a review article: Are the results of the review valid? What are the results? Will the results help locally? Next, the magnitude of the results and its significance are evaluated. Finally, one should look to the applicability of these results to his/her patients. Questions asked in this process include: a) Is the outcome of the study a patient oriented evidence that matters (POEM) or a disease oriented evidence (DOE)? b) Does the study population correspond to your practice population? c) What method is described to answer the research question? d) How will this study impact on your practice? 11 Evidence-Based Medicine Applying the evidence to individual patient care EBM will modify individual patient care, leading to the use of proven therapies and diagnostic tests only where data exists to support their use, to the withdrawal of those which are unproven, and to closer scrutiny of those for which clear evidence for continued use is lacking. As physicians become more aware, patients become better educated and a more equitable physician-patient relationship follows. Evaluating the process A periodic review of the process will show how well a clinical question has been answered and advise as to its replicability either in the same or another setting. The more EBM is used, the more the challenges to the practitioner and the more the experience gained. The Logic Behind EBM To make EBM more acceptable to clinicians and to encourage its use, it is best to turn a specified problem into answerable questions by examining the following issues: Person or population in question. Intervention given. Comparison (if appropriate). Outcomes considered. 12 Evidence-Based Medicine For example: Is an elderly man given nicotine patches more likely to stop smoking than a similar man who is not? Next, it is necessary to refine the problem into explicit questions and then check to see whether the evidence exists. But where can we find the information to help us make better decisions? The following are all common sources: Personal experience for example, a bad drug reaction. Reasoning and intuition. Colleagues. Bottom drawer (pieces of paper lying around the office, and son on). Published evidence Analyzing information In using the evidence it is necessary to: Search for and locate it. Appraise it. Store and retrieve it. Ensure it is updated. Communicate and use it. Every clinician strives to provide the best possible care for patients. However, given the multitude of research information available, it is not always possible to keep abreast of current developments or to translate them into clinical practice. One must also rely on published papers, which are not always tailored to meet the clinicians needs. 13 Evidence-Based Medicine Advantages and disadvantages in practicing EBM Advantages Clinicians upgrade their knowledge base; It improves clinicians understanding of research and its methods; It improves confidence in managing clinical situations; It improves computer literacy and data searching skills; It allows group problem solving and teaching; Juniors can contribute as well as seniors; For patients, it is a more effective use of resources; It allow better communication with the patient about the rationale behind treatment; It improves our reading habit; It leads us to ask questions, and then to be skeptical of the answers: what better definition is there of sciences? Wasteful practices can be abandoned; Evidence-based medicine presupposes that we keep up-to-date, and makes it worthwhile to take trips around the perimeter of our knowledge; Evidence-based medicine opens decision making processes to patients. 14 Evidence-Based Medicine EBM forms part of the multifaceted process of assuring clinical effectiveness, the main elements of which are: - Production of evidence through research and scientific review. - Production and dissemination of evidence-based clinical guidelines. - Implementation of evidence-based, cost-effective practice through education and management of change. - Evaluation of compliance with agreed practice guidance and patient outcomes this process includes clinical audit. Disadvantages It takes time to learn the methods and to put them into practice; There is the financial cost of buying and maintaining equipment; Medline and other electronic databases are not always comprehensive; Authoritarian practitioners may find these methods threatening. Forms of evidence Evidence is presented in many forms, and it is important to understand the basis on which it is stated. The value of evidence can be ranked according to the following classification in descending order of credibility: 15 Evidence-Based Medicine I. Strong evidence from at least one systematic review of multiple well-designed randomized controlled trials. II. Strong evidence from at least one properly designed randomized controlled trail of appropriate size. III. Evidence from well-designed trials such as non-randomised trials, cohort studies, time series or matched case-controlled studies. IV. Evidence from well-designed non-experimental studies from more than one center or research group. V. Opinions of respected authorities, based on clinical evidence, descriptive studies or reports of expert committees. How do we balance cost and quality in healthcare? Where should investments be made that improve care in a cost effective way ? How do we engage patients more responsibility in their care ? How do we maintain and enhance the professional integrity of the caring professions ? How do we narrow the gap between knowledge and practice? The practice of evidence-based medicine is the starting point for answering these overarching questions. 16 Evidence-Based Medicine Evidence-based medicine is not cookbook medicine; it is basis for the next generation of health delivery in the Gulf States. 17 Evidence-Based Medicine Evidence-Based Medicine Resources Textbooks 1. Evidence-based medicine: How to practice and teach EBM. Sackett DL et.al. New York, Churchill Livingstone,1997. 2. Evidence-based healthcare: How to make health policy and management decisions. Muir Gray JA. New York, Churchill Livingstone,1997. 3. Towards evidence-based medicine in general practice. Rosser W. Blacwell Science Inc., 1997. 4. Evidence-Based Family Medicine. Rosser WW, Shafir MS. Hamilton. B.C. Decker Inc. 1998. Also available in CD-ROM. 5. The evidence-based primary care handbook. Ed Mark Gabbay. Royal Society of Medicine Press, 2000. 6. Users Guides to the Medical Literature. Essentials of Evidence-Based Clinical Practice. Gordon Guyatt, MD. Drummond Rennie, MD. 2002. 7. Users Guides to the Medical Literature. A Manual for Evidence-Based Clinical Practice. Gordon Guyatt, MD. Drummond Rennie, MD. 2002. 8. Evidence-Based Public Health. Ross C. Brownson, Elizabeth A. Baker, Terry L. Leet, Kathleen N. Gillespie. 2003. 18 Evidence-Based Medicine Reappraised literature Peer-reviewed publications which retrieve and appraise articles from prominent medical journals through rigorous criteria: The American College of Physicians Journal Club and Evidence Based Medicine, a joint venture between ACP and BMJ. Published six times a year, ACP Journal Club is the critically acclaimed source to find the most important articles among the thousands published each year in peer-reviewed journals. ACP Journal Clubs distinctive format facilitates rapid assessment of each studys validity and relevance to your clinical practice. /journals/acpjc /jcmenu.hun. Evidence-Based Nursing.