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ClinicalDecisionMakingI:InfoMasteryandEvidenceBasedMedicine
(FeelingGoodAboutNotKnowingEverything)*
Objectives:Atconclusionofthelecturebeableto
Applythedeductivereasoningapproachtomedicaldecisionmaking.
Describethecomponentsofgoodhealthcaredecisions.
Discusstherelevanceandvalidityofagivenpieceofmedicalliterature.
Applytheusefulnessequationtoagivenclinicalscenario
DistinguishPOEMsfromDOEs,andtheimportanceofbothinresearchandclinicalpractice.
Constructacoherent,clinicallyrelevantquestion.Appliedtoadiagnosticstudy.
DescribethestepsintheEBMprocess.
TRUTH:Whatisitformedicaldecisionmaking?*

Thetruthcanmeandifferentthingsfordifferentpeople,oritcanmeanthesameforpeopleatdifferent
times

Communityconsensusthecommunitystandardforpractice
IntheUSit'sthenationwidestandard
HMOdictum
HMOtechnicallycouldn'tdictatehowphysicianscouldpracticemedicine,butdecidedwhether
theywillpaythephysicianstopracticehowtheydecidethemto
Thebottomline$$$
Ifthereisatestforwhichtheinsuranceisn'tpayingandthepatientcanafforditthat'sfine
Ifthepatientcannotaffordittheymaynotgowiththattreatmentplan
Whatexpertsdo
Inresearchorinclinicalmedicinedevelopfamiliaritywiththesubjectmattertheyworkwith
mostoften
Developexpertisebasedonexperience
Experiencebasedonmanyyearsofsuccesswithacertainmethodoraparticulartreatment
Maynotshowstudiestoshowthatscientificallyitworks,butonlyexperienceshowsthatitworks
Whatlawyerstellustodo
Indealingwithlawsuits,lawyerstellustodounnecessaryandorderunnecessarytestsororder
teststhatperformharm
Lawyerspokeholesincase
Whatmypersonalexperiencetellsme
Figuringoutthetruthisbasedonpersonalexperience
Whatthepatientwants
Backintheday,itdidn'tmatterwhatthepatientwanted
Providertoldthepatientwhattheyexpectedandwhatwewantedthemtodo
Nowadays,patientshavereadyaccessformedicalinformation
Someveryreliable,somenotreliable
Haveexpectationsonparticipatingintheirtreatment
NicoleNotes:
Communityconsensus/thecommunitystandardusedtovaryfromcommunitytocommunity.Nowthat
communicationsarebetterweretalkingaboutthenationalstandardofcare
HMOdictumforprescriptioncover,theHMOoranyunsurercanbethetruthforwhatwedowithour
patient
Thebottomline$$$manyinsurersareraisingthepriceofcostsharing.
Moreandmoredeductiblesandcopaysarerising.thatscostsharing.
Ifyoudevelopacondition,acopaycanbesohighapersoncantfindit.
Whatexpertsdobasedonsomebodysexperiencebuiltupovermanyyears.thatbecomesthetruth
Whatlawyerstellustodocommonissueamongpractitionersisfailuretodiagnoseariskofperforminga
riskwashigherthanthebenefitofthetest
Defensivepracticeofmedicine.Pplordermedicallyunecessarytests&treatments.becomingthetruth.

Whatmypersonalexperiencetellsmelivingneartoxicareadumpwithrashsimilartolymedisease
youredoingsomethingotherthanwhatthesciencewouldindicate
Whatthepatientwantspatientshaveeasyandreadyaccesstogoodandbadinformationontheinternet
WaysofReachingTheTruth
FaithTheseductiveapproach
Trustme,IknowwhatImdoing!Inmyopinion
Someonewhodisregardsthescience&decidesthatheorsheknowsbest&isthebestwaytodo
things
ShowedusavideoaboutAutisticpeopleandhyperbaricchambertreatment
Istheimprovementb/cofactualchamberitself?
FaithTheseductiveapproachmoreseriouslyspeaking
InmyexperienceHBOTStory
Moreprofessionalwayofsayingthatisinmyexperience
Experiencedpractitionerstreatingpatientsbecausetheyvedoneitthesameway
Treatmentbasedonopinionandbiasnotbasedonevidence
Evenifthereareresult,cantsayitstheresultoftheHBOT
Canseemreasonableifsomeoneisdesperatefortreatmentforadisease
ItmakessenseTheInductiveApproach
Basedonpathophysiology
Itoughttowork
Theseoughtto,butdont:
Rightheartcatheterization(SchwannGantzCatheter)
Turnedouttonothavealotofgoodsciencebehinditandwhetheritbenefitted
criticallyillpatients
Lookedatmortalityandcostofcare,andfoundnodifferenceinmortalityand
didnotaffectintensivecareunitlengthofstay
Costwashigher
HRT
DiureticsforARF
Acuterenalfailure,ifyougavediureticsandgotgoodurineflowthanheading
offacuterenalfailure
Didntlookatthescienceonwhetherthatwastrueornot
Foundnochangeinultimateoutcomeinthesepatients
Sweepinggeneralizations
WaysofReachingTheTruth:AMedicalParadigmShift*
EvidenceBasedMedicineTheDeductiveApproach
Inlogictypeofinferenceofargumentthatisdeductedandreportstobevalid
Distinguishedfrominductionbasedonassumption
Nopresumptioninthedeductiveapproach
Basedonoutcomesresearch
Puttingitallbacktogether
Demonstrationthatitdoesordoesntwork
Findingatheorybasedonobservationalresearchthencreatingahypothesisbasedon
observationalresearchthatcanbetested
WhatisEvidenceBasedMedicine?*
Aparadigmbywhichcliniciansaskaclinicallyrelevantquestion,andmakemedicaldecisionsabout
individualpatientsthroughtheidentification,evaluationandapplicationofthemostrelevantandvalid
informationavailable.
Aparadigmisawayofthinkingorpattern

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Paradigm:Asetofassumption,concepts,values&practicethatconstitutesawayofviewing
reality
Itusesdatatocreateinformationtogainknowledgewhichcanleadtowisdom.

Data*
Facts,whichbythemselveshavenomeaning.
Fact:Heartratescanrangefromzerotoover300beatsperminute.Whatdoesthismean?
Information*
Thatwhichleadstounderstanding.Themeaningweassigntofacts.
Information:Heartratesabove100arecalledtachycardia.
Itisnotknowledge,butistheprinciplecontentofmostscientificjournals
Knowledge*
Anorderlysynthesisofinformationthroughtheprocessofdeepandextensivelearningand
understanding.
Knowledge:Therearedifferentkindsoftachycardia.Somearebenign&somearedangeroustoapatient.
Wisdom
Theappropriateapplicationofknowledgetoaparticularsituationbasedonintuitiongainedfrom
experience.
Wisdom:ItisgoodtoshockVtach.Itisbadtoshocksinustach.
WhatEBMis
NOT.Cookbook
Wayofapplyingrulesorstepsformakingadiagnosisorfindingatreatment
Informationaloneisnotenough
EBMisatool
Onetoolinthearsenalofclinicalpractice
Oneofmanyspheresofcompassionatecare
ProvidingtheCompassionateHealthCare4Components****TESTQUESTION****

VennDiagram:
Artofmedicine
Scienceofmedicine
Patientvalues
Cost
AdditionalSkillsNeededByClinicians
GoodatH&PE
Gettingafewelementsofhx,canchangetheprevalenceofadiseasewhentryingtodecidewhat
diagnosticteststogetandinterpretingtheresultsofadiagnostictests
Evenonefactcanchangethepretestprobability
Understandingofpatient,family,community
Developrelationshipwithpt.
Needthemtotrustyousothattheywillbelievewhatyoutellthemandwhenyoushareevidence
tothemaboutacertaintestortreatment
Theywilltrustyouinthedecisionmakingprocess
Empathy,identifywithbeliefsystemofpt.
Practicalknowledgeofresourcesavailable
Needtoknowsomeknowledgetohelppatientsinguidingthemintheirdecisionmakingprocess
Inanykindoftestingandtreatmentofapt.
PracticeofEBM
**Beginswiththepatient.**TESTQUESTION
Notwithknowledgeorinformation.
EBMonlyaddsbenefitofbestevidencetoaidindiagnosis,treatment,prognosis,etc.
Bestthatcanbefound

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Itisacomplementtowhatwealreadyunderstandaboutapatient.
Asaresultofwhathasalreadybeendoneforthept.
Somethingthatcompletesaconcept
Worksasacomplementwithdiagnosis,treatmentandprognosis
Helpsuswithamanagementplanbutisnotthesolepiece
AdvantagesofEBM
Frameworkforknowingwhentobeginusingnewtests/technology/treatment
Whentodiscardoldpractices
Howtoanswerquestionsdailyinthecareofpatients
Encouragesahealthyskepticismandcultureofinquirythatstimulatesnewthinking
Ex:In1700sleacheswereusedinmedicinealotitwaslaterdiscoveredthattheydidn'thelp
andthatitcouldactuallycauseharm.Useofleacheshascomebackreimplantationofdigits
LimitationsofEBMandResearch
Studiesorstudypopulationsmayaddressnarrowquestions
Numberofsystematicreviewsisrelativelysmallcomparedtobodyofmedicalliteratureoutthere
Specializedsettingsmaylimitapplicability
Pharmaceuticalfundingcanleadtoconflictsofinterestlikeselectivereportingoffindings
HOWTOPRACTICEEBM
THE5STEPAPPROACH

EBMRequirements:
Askaclinicallyrelevantquestion
Typicallyaquestionaboutapatient
Relevanttothepatients
Trackdownthebestevidence
Criticallyappraisetheevidenceforrelevanceandvalidity
Relevancehowcloselyitappliestoyourpatient(theonewhomtheclinicallyrelevant
questionisbeingaskedabout)
Validityhowtrueistheevidence
Applytheevidencetoclinicalpracticeforindividualpatients
Useitonthepatientforwhichyouaskedtheclinicallyrelevantquestionabout
Evaluatetheefficiency&effectivenessofthatprocessClinicalOutcomes.

Whyaskquestions?:
Ifyoudontknowthequestion,youwontfindtheanswer!
Doestakepracticetoasktheclinicallyrelevantquestionsinawaythatwillhelpyour
patient,andhelpyoufindtheevidencethatthepatientneeds
1999studyfound3.2Qsforevery10patients
64%ofQsgounanswered.
PDApersonaldigitalassistant
Notinternetconnected,functionedashandheldcomputers

Example:
32yearoldmalepresentstotheofficewithsymptomsofanupperrespiratoryinfection(URI).
Yoususpectsinusitis.
Severalquestionscanbegeneratedaboutthecareofthispatient.
SampleQuestions*
DoesroutineuseofsinusXRaysinptswithsuspectedacutesinusitisimproveclinical
outcomes?
Diagnosticquestion
Inpatientswithacutesinusitis,dooralornasaldecongestantsreducethedurationof

symptoms?
Therapeuticquestion

**Componentsofagoodquestion**FormallEBMquestionsareplacedin

Ppopulation,problem,patient

Iintervention

Comparison
Hopingforcontrolledstudies(RCTforbetterquality)

Outcome
Shouldbethingspeoplecareabout!
Livingbetter:fewersymptoms,increasedqualityoflife,lesspain,etc.
Notasign,pt.scantalwaysexperienceasign
WHATWENEED
Instantaccesstoinformationatthepointofcarethatisrelevantandvalidtocareofpatients.
Thestethoscopeofthe21stcentury
Yourrole:helppt.sobtainanddeciphergoodinfo
Handhelds/Smartphonescanbehelpful,nowthatWiFi/4Gorfasterdataspeedsareavailable.
PART2:INFOMASTERY
EVALUATINGRELEVANCEANDVALIDITY
Evidencethathasgoodrelevanceandvalidity
MedicalInformationSystemaBlizzard*
Journal
Peerreviewedjournals,doesn'talwaysmeangoodquality
Throwaways
Goodsourceofsecondaryliterature
Reviewofthemedicalliteraturetolookforanswersintheprimaryliterature
Monograph
Take1conditionandgiveyouagoodsummaryofanatomyandphysiologyofthenormal
systemandvariouscommonpathologies
Talkabouttreatmentsavailableforthatsubjectcondition
Oftenindepthandextensiveandhaveaformoffunding
Secondaryliterature
Lookingatprimaryresearchdonebyotherpeopleandcompilingandreportingit
tothepublic
PracticeGuideline
Publishedbyprofessionalorganizationsorthefederalgovernment
Suggestionsofgoodwaysbasedonevidencetopractice
Eitherintermsofdiagnosingortreatingvariousconditions
CMEcourse(lecture)
Expertsthathavecompiledtheinformationbasedonprimaryresearchandputitintoa
CMEformat
ClinicalExperience
Clinicianscandevelopexperiencebasedonexpertiseonencounteringpatientswitha
limitedsetofclinicalproblemsandtrydifferenttreatmentstoseewhichoneswork
Colleagues
Colleaguesyoutrustandknowareexpertsonasubject
Textbooks
GoodsourceofdatedinformationifbasedonevidencestemsonRCT
Willalwayshaveanaturaltimelagwithtextbooks
Takesyearstoformtextbooks
PharmaceuticalReps

Canbegoodforanarrowrangeofinformationforpharmaceuticaland
pharmacotherapeutics
Computers
Onlinesources
Audiotapes/podcasts
Newsletters
Limitedresearch
Somearegoodqualityandsomehaveafinancialincentives
Newsmedia
Patients:generallyknowwhatisgoingon
Bestqualityprimaryresearch:nationallibraryofmedicine
About10millionarticlesonthisdatabasewouldbeverytimeconsumingtogothrough
allofthem
**TheUsefulnessEquation**
Goal:Spendleasttime&energyfindingthebestevidenceavailable.
Threeattributesofthebestinformation:(higher=better)
Relevanttoeverydaypractice
Becorrect(i.e.valid)
Requirelittleworktoobtain
DeterminingRelevance:
IsitcommontomedicineaspracticedbyPAsorcliniciansyoumaybesupportingwithresearch?
Willourpatientscareaboutthis?Doesitanswerthequestion?Iftrue,willthischangemypractice?
IsitaDOEoraPOEM?
POEM
Patient
Oriented
Evidence
thatMatters
Matterstoyou,theclinician,becauseifvalid,willrequireyoutochangeyour
practice&matterstothePt.
PatientOrientedEvidencethatMatters(POEMS)*
Outcomesimportanttopatients:morbidity,mortality,qualityoflife,costs,pain
Finaloutcomes:noassumptionsrequired,(weknowtheanswer)
Knowifitdoeswork,doesntwork,orcanttellbasedontheevidence
Example:controlofothermajorriskfactorsinType2diabetesaffectsmorbidityandmortality
morethantightcontrolofbloodglucose
PATIENTCENTERED,OUTCOMESBASED
DiseaseOrientedEvidence(DOE)*
Focusesonpathophysiology,pharmacology,etiology(#sandtests)
Intermediateoutcomesrequiringassumptionsthattreatmentisbest
Example:tightglucosecontrolinType2diabetesdecreasesproteinuria
***WithoutDOEswewouldnothavePOEMs***
NeedtheDOEsfirsttogettothePOEMs
ExamplesofDOEstudies*
CASTtrial(Treateddiseasewasventriculararrhythmia)
Transfusingwhenwedontaddresswhythehemoglobinislow!(Treateddiseasewas
hemoglobinemia)
Clickerquestion:
A.)Doesbedrestimproveoutcomesinpatientswithsciatica?P=1orD=2

Thisisincomplete
B.)Doeshigh
dose
amoxicillinfor
otitismedia
resultinlower
microbial
countsin
middleear
fluids?
P=1or
D=2
C.)Does
prophylactic

lidocainepreventventriculararrhythmiasinpostopCABGpatients?
P=1orD=2Needatesttoconfirmthearrhythmia
D.)Do21mgnicotinepatchesincreasethelongtermquiterateforpatientswhowanttoquitsmoking?
POEM
Relevance:TypeofEvidence*
POE:Patientorientedevidence
mortality,morbidity(Sxs),qualityoflife
DOE:Diseaseorientedevidence
Pathophysiology,pharmacology,etiology,prevalence,etc.
Allincreaseourunderstandingofdisease.
HelpusgettothePOEM,butnotPOEMthemselves
LessrelevantinEBM
ComparingDOESandPOEMs*
SometimesthesameconditioncanbeaPOEMoraDOEbasedontheoutcomelookingat
Firstlineincreasesmortalityiswhatpatientcareabout,andPOEMcontradictsDOEstudy
Secondlinept.cantfeelBpexperiencebloodpressurewithabptest(measuringit),decreasesmortality
pt.scareaboutthese,POEMagreeswithDOE
ThirdlinePSAiscontroversial
PSAscreeningisatestsoitsaDOE,notestinvolvedinmortality
AlsomanyothervariablescanincreaseaPSA
Atleast1organizationnowsaysthatitdoesntdecreasemortality

Relevance:Frequency:Whatkindsofarticlestoread*
Articlesthatwewanttospendtimelookingat

Patientorientedevidenceisatthetoppartofthegridanddiseaseorientedevidenceisinthelower2cells
Relevance1isthebestsourceofPOEMs
Adiseaseorissuethatiscommonandlikelytoseeineverydaypracticeinallsortsofmedical
specialties
Somethingthatmattersgreatlytopatients
Ex:hemorrhoids
Relevance2canbeagoodsource
Aconditionthatmatterstopatientsbutismoreraretoseeineverydaypractice
Readthestudyonlyifthereistime
Ex:Traveler'sdiarrhea
Relevance3notasgoodofasource
Patientsdon'tcareasmuchaboutdiseaseorientedevidenceunlesstheygetadiagnostictest
performed
Typicallyacommonproblemseenineverydaypractice
Relevance4istheworstsource
Patientsdon'tcareaboutdiseaseorientedevidence,especiallywhentheconditionishardlyever
seenineverydaypractice
Sometimesresearchismoreboring
VALIDITY
ISTHISTHETRUTH???OrHowClosetotheTruthisit?
Knowingthestats..SN,SP,etc.
Remember,lookforasmuchvalidityaspossibletominimizetheWORKtoyou!
Pvalues,CIs,RCTs,concealedallocation,blinding,etc.,areallwordsthatprotectyoufrom
beingmisled.
Allthingsyouwanttoseeinawellconductedstudy
Relevancecomesfirst,thencomesvalidity(almostalwayslaidoutintheabstract)