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Evidence based medicine By dr. Balgis MSc. CM FM.

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Evidence based medicineBy dr. Balgis MSc. CM FM.The science of medicine is continuously changing if we do not adapt to this change, the following might happen a. !e may have not give our patient effective treatmentsb. !e may have wasted precious resources."ld model of decision ma#ing$ The traditional model of medical education depended on learning collection facts, principles and rules of thumbs that would serve individual for a professional life.$ The method passive dissemination of information %didactic lecture in large session halls&$ The ' (rofessor) or the ' E*pert) become the standard source of information for decision ma#ing$ (roblem can be answered by as#ing colleagues and local e*pert, reading te*t boo#s % out of date by the time they are published&, or browsing +ournals %but which +ournal should you loo# at&,ew model of medical decision ma#ingThere is now a strong trend towards the view that medical education should be lifelong, oriented towards problem solving and based on the principle that-. Clinical e*perience is important but observations must be recorded systematically and without bias.. /egular reference must be made to original literature0. The results of studies must be critically e*amined using rules of evidence before applying it to practiceMeaning of EBM according to others$ E*perience1based medicine1 the oldest ones are the most valid$ Elo2uenc1based medicine1 the loudestvoice is the most heardEvidence-Based Medicine Evidence-Based Medicine DefinitionDefinitionthe conscientious, the conscientious, explicit and judicious explicit and judicious use of current best use of current best evidence in making evidence in making decisions about the decisions about the care of the individual care of the individual patientpatient

the conscientious, the conscientious, explicit and judicious explicit and judicious use of current best use of current best evidence in making evidence in making decisions about the decisions about the care of the individual care of the individual patientpatient

The practice of EBM requires the integration of The practice of EBM requires the integration of individual clinical expertiseindividual clinical expertise and patient values and patient values ith the ith the best available external clinical evidencebest available external clinical evidence from from s!stematic researchs!stematic research" "

The practice of EBM requires the integration of The practice of EBM requires the integration of individual clinical expertiseindividual clinical expertise and patient values and patient values ith the ith the best available external clinical evidencebest available external clinical evidence from from s!stematic researchs!stematic research" "

Patients Needs/PreferencesClinical ExperienceBest Clinical Evidence!hat evidence1based medicine is3$ 4ood doctors use both individual clinical e*pertise and the best available e*ternal evidence, and neither alone is enough. 5!ithout the former, practice ris#s becoming evidence1tyrannised, for even e*cellent e*ternal evidence may be inapplicable or inappropriate for an individual patient.5 !ithout the latter, practice ris#s becoming rapidly out of date, to the detriment of patients and patient1care.Evidence based medicine$ EBM was developed in canada to teach medical students but was latter applied to solving clinical problem$ The aim of EBM is to encourage the use of diagnostic test and therapeutic interventions that are proven to be accurate, effective and safe in clinical research.$ EBM fits with recommendations to ma#e undergraduate and postgraduate medical education curriculum more problem centered, directed toward lifelong learning and less about memori6ing a static body of #nowledge.Evidence1based medicine is not 'coo#1boo#) medicine3$ (atients cannot go through a 7treatment tunnel8 assuming the same management is appropriate and the same outcomes important to each$ E*ternal clinical evidence can inform, but can never replace, individual clinical e*pertise $ 9our clinical accumen decides whether the e*ternal evidence applies to the individual patient at all and, if so, how it should be integrated into a clinical decision.Evidence1based medicine is not 'cost1cutting) medicine3$ The aim is to give most benefit to each individual patient$ To apply the most efficacious interventions which will ma*imise their function, 2uality, and 2uantity of life$may raise rather than lower the cost of their care.EBM is neither old1hat nor impossible to practice3$ The former argument falls before the evidence35of stri#ing variations in the integration of patient values into our clinical behaviour5 of stri#ing variations in the rates with which clinicians provide interventions of established benefit and uselessness to their patients.5 in the inability of clinicians to #eep abreast of important medical advances reported in primary +ournalsThe patient 1. Start with the patient -- a clinical problem or question arises out of the care of the patient The question 2. Construct a well built clinical question derived from the caseand classify it into one categoryThe resource 3. Select the appropriate resources! and conduct a searchThe evaluation ". #ppraise that evidence for its validity closeness to the truth! and applicability usefulness in clinical practice!The patient $. %eturn to the patient & 'a(e a clinical dicesion to apply or not to apply the result of the study )integrate that evidence with clinical e*pertise+ patient factors to carry out the dicesionSelf-evaluation ,. -valuate your performance with this patientWhat is Evidence-based What is Evidence-based PracticePracticeClinical Skills Keepingup to dateClinical questionudit!ind the Evidenceppl" to PracticeCritical ppraisalTypes of :uestions#herap"$prevention %uestionPrognosis %uestion question concerning the effectiveness of a treat&ent or preventative &easure question concerning outco&e of patient 'ith a particular conditionDiagnosis %uestion(ar& %uestion question concerning the abilit" of a test to predict the likelihood of a disease question concerning the likelihood of a therapeutic intervention to cause har&Type of Question Type of Question Suggested best type of Study Suggested best type of Study#herap" #herap" )C#*cohort * case control * case series )C#*cohort * case control * case seriesDiagnosis Diagnosis Prospective+ blind co&parison to a gold standard Prospective+ blind co&parison to a gold standardEtiolog"$(ar& Etiolog"$(ar& )C# * cohort * case control * case series )C# * cohort * case control * case seriesPrognosis Prognosis Cohort stud" * case control * case series Cohort stud" * case control * case seriesPrevention Prevention )C#*cohort stud" * case control * case series )C#*cohort stud" * case control * case seriesClinical E,a& Clinical E,a& Prospective+ blind co&parison to gold standard Prospective+ blind co&parison to gold standardCost Cost Econo&ic anal"sis Econo&ic anal"sisTypes of Research StudiesTypes of Research StudiesCertain study designs are superior to others Certain study designs are superior to others when answering particular questions. when answering particular questions. RCT are considered the best for addressingRCT are considered the best for addressing questions about therapy.questions about therapy. Etiology questions may be addressed by case-controlEtiology questions may be addressed by case-control & cohort studies. & cohort studies.ther aspects rele!ant to study design include ther aspects rele!ant to study design include placebo comparison group and follow-up. placebo comparison group and follow-up. Evidence P"ra&idEvidence P"ra&idMeta-nal"sisMeta-nal"sis S"ste&atic )evie'S"ste&atic )evie' )ando&i-ed Controlled #rial)ando&i-ed Controlled #rial Cohort studiesCohort studies Case Control studiesCase Control studies Case Series$Case )eportsCase Series$Case )eports ni&al research ni&al research#his is often referred to as the . #his is often referred to as the .evidence p"ra&id evidence p"ra&id./ 0t is./ 0t is used to illustrate the evolution of the literature/used to illustrate the evolution of the literature/ #he base of the p"ra&id is 'here infor&ation usuall"#he base of the p"ra&id is 'here infor&ation usuall" starts 'ith an idea or laborator" research/ s these ideasstarts 'ith an idea or laborator" research/ s these ideas turn into drugs and diagnostic tools the" are tested inturn into drugs and diagnostic tools the" are tested in laboratories &odels+ then in ani&als+ and finall" inlaboratories &odels+ then in ani&als+ and finall" in hu&ans/ #he hu&an testing &a" begin 'ith volunteershu&ans/ #he hu&an testing &a" begin 'ith volunteers and go through several phases of clinical trials beforeand go through several phases of clinical trials before the drug or diagnostic tool can be authori-ed for usethe drug or diagnostic tool can be authori-ed for use 'ithin the general population/ )ando&i-ed controlled'ithin the general population/ )ando&i-ed controlled trials are then done to further test the effectiveness andtrials are then done to further test the effectiveness and efficac" of a drug or therap"/efficac" of a drug or therap"/ As you move up theAs you move up the pyramid the amount of available literaturepyramid the amount of available literature decreases, but increases in its relevance to thedecreases, but increases in its relevance to the clinical setting. clinical setting. "eta-#nalysis"eta-#nalysis takes the s"ste&atic revie' 1see takes the s"ste&atic revie' 1see belo'2 a step further b" using statistical belo'2 a step further b" using statistical techniques to co&bine the results of several techniques to co&bine the results of several studies as if the" 'ere one large stud"/ studies as if the" 'ere one large stud"/ Systematic Re!iewsSystematic Re!iews usuall" focus on a clinical usuall" focus on a clinical topic and ans'er a specific question/ E,tensive topic and ans'er a specific question/ E,tensive literature searches are conducted to identif" literature searches are conducted to identif" studies 'ith sound &ethodolog"/ #he studies are studies 'ith sound &ethodolog"/ #he studies are revie'ed+ assessed+ and su&&ari-ed according revie'ed+ assessed+ and su&&ari-ed according to the predeter&ined criteria of the revie' to the predeter&ined criteria of the revie' question/question/Randomi$ed Controlled TrialsRandomi$ed Controlled Trials are carefull" are carefull" planned pro3ects that stud" the effect of a planned pro3ects that stud" the effect of a therap" or test on real patients/ #he" include therap" or test on real patients/ #he" include &ethodologies that reduce the potential for &ethodologies that reduce the potential for bias and that allo' for co&parison bet'een bias and that allo' for co&parison bet'een intervention groups and control groups 1no intervention groups and control groups 1no intervention2/ Evidence for questions of intervention2/ Evidence for questions of diagnosis is found in prospective trials 'hich diagnosis is found in prospective trials 'hich co&pare tests 'ith a reference or .gold co&pare tests 'ith a reference or .gold standard. test/ standard. test/ Randomi$ed Controlled Trial %RCT&Randomi$ed Controlled Trial %RCT&Cohort studyCohort studyCohort Studies Cohort Studies take a large population and follo' patientstake a large population and follo' patients 'ho have a specific condition or receive a particular'ho have a specific condition or receive a particular treat&ent over ti&e and co&pare the& 'ith another grouptreat&ent over ti&e and co&pare the& 'ith another group that is si&ilar but has not been affected b" the conditionthat is si&ilar but has not been affected b" the condition being studied/being studied/ #nswers prognosis' etiology' pre!ention questions #nswers prognosis' etiology' pre!ention questionsCohorts are defined populations that' as a whole' areCohorts are defined populations that' as a whole' are followed in an attempt to determine distinguishingfollowed in an attempt to determine distinguishing subgroup characteristics.subgroup characteristics. Researchers identify and compare two groups o!er aResearchers identify and compare two groups o!er a period of time. period of time.#t the start of the study' one of the groups has a#t the start of the study' one of the groups has a particular condition or recei!es a particular treatment'particular condition or recei!es a particular treatment' and the other does not. and the other does not.#t the end of a certain amount of time' researchers#t the end of a certain amount of time' researchers compare the two groups to see how they did. compare the two groups to see how they did.Case Control studyCase Control studyns'ers prognosis+ etiolog"+ prevention ns'ers prognosis+ etiolog"+ prevention questionsquestions0dentifies patients 'ho alread" have the 0dentifies patients 'ho alread" have the outco&e of interest and control patients 'ithout outco&e of interest and control patients 'ithout that outco&e+ and look back to see if the" had that outco&e+ and look back to see if the" had the e,posure of interest or notthe e,posure of interest or not// #hese t"pes of studies are often less reliable #hese t"pes of studies are often less reliable than rando&i-ed controlled trials and cohort than rando&i-ed controlled trials and cohort studies because sho'ing a statistical studies because sho'ing a statistical relationship does not &ean than one factor relationship does not &ean than one factor necessaril" caused the other/necessaril" caused the other/ Case series & Case ReportsCase series & Case Reports Case SeriesCase Series consist of collections of reports consist of collections of reports on the treat&ent of individual patients/ on the treat&ent of individual patients/ Case ReportCase Report is a report on a single patient/ is a report on a single patient/ Because the" are reports of cases and use Because the" are reports of cases and use no control groups 'ith 'hich to co&pare no control groups 'ith 'hich to co&pare outco&es+ the" have no statistical validit" / outco&es+ the" have no statistical validit" / ns'ers prognosis+ etiolog"+ prevention ns'ers prognosis+ etiolog"+ prevention questionsquestionsPractice 4uidelinesPractice 4uidelines(ractice )uidelines (ractice )uidelines are s"ste&aticall" developedare s"ste&aticall" developed state&ents to assist practitioner and patient &akestate&ents to assist practitioner and patient &ake decisions about appropriate health care for specificdecisions about appropriate health care for specific clinical circu&stances/ 4uidelines revie' and evaluateclinical circu&stances/ 4uidelines revie' and evaluate the evidence and then &ake e,plicit reco&&endationsthe evidence and then &ake e,plicit reco&&endations for practice/for practice/ #he p"ra&id serves as a guideline to the hierarch" of#he p"ra&id serves as a guideline to the hierarch" of evidence available/ 5ou &a" not al'a"s find the bestevidence available/ 5ou &a" not al'a"s find the best level of evidence to ans'er "our question/ 0n thelevel of evidence to ans'er "our question/ 0n the absence of the best evidence+ "ou then need to considerabsence of the best evidence+ "ou then need to consider &oving do'n the p"ra&id to other t"pes of studies/ &oving do'n the p"ra&id to other t"pes of studies/;evels of Evidence$ ;evel -3/andomi6ed Clinical Trials$ ;evel .3DD +ournal derived from ED countries around the world and E>F of the articles are in english.$ @t also contains E million references since -GHH to -GG=.From the guru of EBM 17MEC;@,E is the best general source of current best evidence at present because of its breadth and constant maintenance.Thus, it is important to evidence1based practice that clinicians develop and hone MEC;@,E searching s#ills and ac2uire local access.8Evidence1based Medicine3 how to practice I teach EBM 1 Sac#ett C ; et al-GGJClinical scenario$ (atients usually come in to the clinic for problems. Anfortunately these problem are vague and sometimes not clearly stated. $ To state the problem clearly, you must bear in mind that there are only three important elements that the patient want to #now-. !hat their disease are.. !hat treatment they should be given0. !hat is the result to e*pectBefore attempting to Before attempting to search for the search for the evidence in the evidence in the literature, construct literature, construct a well-built or clearly a well-built or clearly structured question structured question that could be broken that could be broken into the following into the following four partsfour partsBefore attempting to Before attempting to search for the search for the evidence in the evidence in the literature, construct literature, construct a well-built or clearly a well-built or clearly structured question structured question that could be broken that could be broken into the following into the following four partsfour partsThree important elements in clinical research are baically$PIO analysis):$ P - Patient/Population$ I-Intervention$ O - Outcome$PICO analysis):$ P - Patient/Population$ I-Intervention$ C Comparison$ O - OutcomeSome time the researcher can add Method((1)1) ((atient * atient * ((opulationopulation What is the primary problem, What is the primary problem, disease or co-existing conditions?disease or co-existing conditions?On what groups do you want On what groups do you want information? information? How would you describe a group of How would you describe a group of patients similar to the one in patients similar to the one in question? question? Sometimes age or sex of a patient Sometimes age or sex of a patient may be relevant and should be may be relevant and should be includedincluded#!xample" post-menopausal women !xample" post-menopausal women with hypertensionwith hypertension%+& Intervention ,hat medical e!ent do you want to study the effect of- ,hich main inter!ention are you considering' prescribing a drug' ordering a test' ordering surgery-. . . . %.& Comparison Compared to what- /etter or worse than no inter!ention at all or than another inter!ention- ,hat is the main alternati!e to compare with the inter!ention' are you trying to decide between two drugs' a drug and a placebo' or two diagnostic tests-Sometimes there is no comparison. %0& Outcome ,hat is the effect of the inter!ention-,hat do you hope to accomplish' measure' impro!e' or affect with this inter!ention- ,hat are you trying to do for the patient' relie!e or eliminate the symptoms' reduce side effects' reduce cost- .. .6 E1ample2 impro!e quality of life What &akes a clinical question What &akes a clinical question 'ell built7'ell built7$uestion should be directl!$uestion should be directl! relevant to the problem at hand" relevant to the problem at hand" $uestion should be phrased to$uestion should be phrased to facilitate searching for a precisefacilitate searching for a precise anser" anser"Asking a well-built question, likeAsking a well-built question, like many clinical skills, needs practice.many clinical skills, needs practice. %fter constructing the &'() %fter constructing the &'() anal!sis, determine the categor! anal!sis, determine the categor! of the question"of the question"There are the four categories of There are the four categories of EBM questionsEBM questionsCategories of EBM Categories of EBM %uestions%uestionsSolves questions about which Solves questions about which treatment to administer, and what treatment to administer, and what might be the outcome of different might be the outcome of different treatment optionstreatment options#or most therapy questions one may #or most therapy questions one may want to loo$ for the best evidence want to loo$ for the best evidence namely a randomi%ed controlled study, namely a randomi%ed controlled study, and if the study can be a double blind, and if the study can be a double blind, so much the betterso much the better

- !xample" find the evidence for the use of - !xample" find the evidence for the use of

anticoagulants in patients with atrial anticoagulants in patients with atrial fibrillationfibrillationSolves questions about which Solves questions about which treatment to administer, and what treatment to administer, and what might be the outcome of different might be the outcome of different treatment optionstreatment options#or most therapy questions one may #or most therapy questions one may want to loo$ for the best evidence want to loo$ for the best evidence namely a randomi%ed controlled study, namely a randomi%ed controlled study, and if the study can be a double blind, and if the study can be a double blind, so much the betterso much the better

- !xample" find the evidence for the use of - !xample" find the evidence for the use of

anticoagulants in patients with atrial anticoagulants in patients with atrial fibrillationfibrillation3& Therapy3& TherapySolves questions about degree to which aSolves questions about degree to which a test is reliable and clinically useful, totest is reliable and clinically useful, to decide whether the patient would benefitdecide whether the patient would benefit from itfrom it &ost articles compare result of a certain&ost articles compare result of a certain diagnostic test with that of a standarddiagnostic test with that of a standard test regarded as being a 'gold standard' test regarded as being a 'gold standard'- !xample" search for the best diagnostic- !xample" search for the best diagnostic test for (l%heimer)s disease test for (l%heimer)s disease+& 4iagnosis+& 4iagnosisSolves problems Solves problems about the relationship about the relationship between a disease between a disease and a possible cause and a possible cause

- - !xample" find out if a diet !xample" find out if a diet rich in saturated fats rich in saturated fats increases the ris$ of heart increases the ris$ of heart disease, and if so by how disease, and if so by how muchmuchSolves problems Solves problems about the relationship about the relationship between a disease between a disease and a possible cause and a possible cause

- - !xample" find out if a diet !xample" find out if a diet rich in saturated fats rich in saturated fats increases the ris$ of heart increases the ris$ of heart disease, and if so by how disease, and if so by how muchmuch.& Etiology.& Etiology(nswers questions about a patient)s (nswers questions about a patient)s future health, life span and quality of future health, life span and quality of life in the event one chooses a life in the event one chooses a particular treatment option particular treatment option -!xample" find how would the quality of-!xample" find how would the quality of life change for a patient who undergoeslife change for a patient who undergoes surgery for prostate cancersurgery for prostate cancer The next step would be to determine theThe next step would be to determine the best study design needed to answer thebest study design needed to answer the clinical question. clinical question.0& (rognosis0& (rognosisThe Boolean (rinciple$ The venn diagram depicts 0 sets$!hich are designated as set?, set B, set C $ Each set has contents which are referred to elements$ The element consist of some numbers.$ ,ote that the different sets haveoverlapping elements$ Boolean logic can be used to e*press the relationships between the various sets in this diagram, or to identify specific elements.$ This achieved using connectives )?,C)or '"/). The union between set ? and Set B can be e*pressed in Boolean logic as ? "/ Bin the diagram, this would be represented by elements -,.,0,=,> and HB"";E?, ;"4@C?,C K "/ K ,"T$ "/HEART DISEASESHYPERTENSION"/ is M"/E$ The union between set ? and Set B can be e*pressed in Boolean logic as ? "/ Bin the diagram, this would be represented by elements -,.,0,=,> and HB"";E?, ;"4@C$ ?,CHEART DISEASESHYPERTENSIONAND.. The @ntersect of sets ? and B can be e*preseed as? ?,C B in the diagram, this would be repsented by elements . and 0. ,ote that unions K "/ tend to incease the number of elements included, while @ntersects K ?,C tend to do the opposite$ To ma#e things more e*citing, brac#ets '%&) can help us use unions and intersects in the same e*pressionfor e*ample3 % ? ?,C B& "/ C would refer to elements .,0,=,H and E but the similar e*pressions ? ?,C %B "/ C& would refer to elements .,0, and =. B"";E?, ;"4@C$ ,"THEARTDISEASESNotCONGENITALHEARTDISEASES;imits$ ;ocal holdings %for library only&$ ?ge groups$ (ublication types$ ;anguage$ 9ear of publication$ . /andomi6ed controlled trialH.DGJH. N= ?,C N> -.@ scanned the titles and come up with one study to read and confident that this study is the most recent, up todate and relevant@n searching through medline there are several general stepsSTE( @1 develop an initial search strategy using a single disc Step @ ?. phrase the 2uestion as precisely as possible -. The #ind of patient will be perform % specified as a disease entity&.. @ntervention being evaluated % a drug, a diagnostic test, an operative procedure& 0. The outcomes of interest to the researcher % mortality, morbidity, 2uality of life&=. @f needed we can add methodological filter$ STE( @ B 5 @dentify #ey concepts in the 2uestion phrase$ ?t least one of #ey concept should be specified in sufficient detail for a meaningful search to be conducted$ STE( @ C1 Broaden each #ey concepts , to account for differences in use of terminology$ @n preparing to search a database for the #ey concepts that one identifies, a ma+or difficulty to be addresed is the problem of non1uniform medical terminology.$ This problem can be solved in two ways3-. Asing a free te*t search % cancer or new growth or neoplasm or tumor&.. Asing a medical sub+ect heading % MeS