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457 Pages·2010·2.59 MB·English
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EssentialEvidence-BasedMedicine SecondEdition Essential Evidence-Based Medicine Second Edition Dan Mayer, MD cambridge university press Cambridge,NewYork,Melbourne,Madrid,CapeTown,Singapore,Sa˜oPaulo,Delhi CambridgeUniversityPress TheEdinburghBuilding,CambridgeCB28RU,UK PublishedintheUnitedStatesofAmericabyCambridgeUniversityPress,NewYork www.cambridge.org Informationonthistitle:www.cambridge.org/9780521712415 Firstedition(cid:2)c D.Mayer2004 Secondedition(cid:2)c D.Mayer2010 Thispublicationisincopyright.Subjecttostatutoryexception andtotheprovisionsofrelevantcollectivelicensingagreements, noreproductionofanypartmaytakeplacewithout thewrittenpermissionofCambridgeUniversityPress. Firstpublished2010 PrintedintheUnitedKingdomattheUniversityPress,Cambridge AcatalogrecordforthispublicationisavailablefromtheBritishLibrary LibraryofCongressCataloginginPublicationdata Mayer,Dan. Essentialevidence-basedmedicine/DanMayer.–2nded. p.; cm. Includesbibliographicalreferencesandindex. ISBN978-0-521-71241-5(pbk.) 1.Evidence-BasedMedicine. I.Title. [DNLM:1.Evidence-BasedMedicine. WB102.5M4682010] R723.7.M396 2010 616–dc22 2009024641 ISBN978-0-521-71241-5Paperback AllmaterialcontainedwithintheCD-ROMisprotectedbycopyrightandotherintellectual propertylaws.ThecustomeracquiresonlytherighttousetheCD-ROManddoesnot acquireanyotherrights,expressorimplied,unlessthesearestatedexplicitlyinaseparate licence. Totheextentpermittedbyapplicablelaw,CambridgeUniversityPressisnotliablefor directdamagesorlossofanykindresultingfromtheuseofthisproductorfromerrorsor faultscontainedinit,andineverycaseCambridgeUniversityPress’sliabilityshallbe limitedtotheamountactuallypaidbythecustomerfortheproduct. Everyefforthasbeenmadeinpreparingthispublicationtoprovideaccurateand up-to-dateinformationwhichisinaccordwithacceptedstandardsandpracticeatthe timeofpublication.Althoughcasehistoriesaredrawnfromactualcases,everyefforthas beenmadetodisguisetheidentitiesoftheindividualsinvolved.Nevertheless,the authors,editors,andpublisherscanmakenowarrantiesthattheinformationcontained hereinistotallyfreefromerror,notleastbecauseclinicalstandardsareconstantly changingthroughresearchandregulation.Theauthors,editors,andpublisherstherefore disclaimallliabilityfordirectorconsequentialdamagesresultingfromtheuseofmaterial containedinthispublication.Readersarestronglyadvisedtopaycarefulattentionto informationprovidedbythemanufacturerofanydrugsorequipmentthattheyplanto use. ThepublisherhasuseditsbestendeavorstoensurethattheURLsforexternalwebsites referredtointhispublicationarecorrectandactiveatthetimeofgoingtopress.However, thepublisherhasnoresponsibilityforthewebsitesandcanmakenoguaranteethatasite willremainliveorthatthecontentisorwillremainappropriate. Contents Listofcontributors pagevii Preface ix ForewordbySirMuirGray xi Acknowledgments xiii 1 Abriefhistoryofmedicineandstatistics 1 2 Whatisevidence-basedmedicine? 9 3 Causation 19 4 Themedicalliterature:anoverview 24 5 Searchingthemedicalliterature 33 SandiPirozzoandElizabethIrish 6 Studydesignandstrengthofevidence 56 7 Instrumentsandmeasurements:precisionandvalidity 67 8 Sourcesofbias 80 9 Reviewofbasicstatistics 93 10 Hypothesistesting 109 11 TypeIerrorsandnumberneededtotreat 120 12 NegativestudiesandTypeIIerrors 130 13 Riskassessment 141 14 Adjustmentandmultivariateanalysis 156 15 Randomizedclinicaltrials 164 16 Scientificintegrityandtheresponsibleconductofresearch 179 JohnE.Kaplan v vi Contents 17 Applicabilityandstrengthofevidence 187 18 Communicatingevidencetopatients 199 LauraJ.Zakowski,ShobhinaG.Chheda,ChristineS.Seibert 19 Criticalappraisalofqualitativeresearchstudies 208 StevenR.Simon 20 Anoverviewofdecisionmakinginmedicine 215 21 Sourcesoferrorintheclinicalencounter 233 22 Theuseofdiagnostictests 244 23 Utilityandcharacteristicsofdiagnostictests:likelihoodratios, sensitivity,andspecificity 249 24 Bayes’theorem,predictivevalues,post-testprobabilities,and intervallikelihoodratios 261 25 ComparingtestsandusingROCcurves 276 26 Incrementalgainandthethresholdapproachtodiagnostictesting 282 27 Sourcesofbiasandcriticalappraisalofstudiesofdiagnostictests 295 28 Screeningtests 310 29 Practiceguidelinesandclinicalpredictionrules 320 30 Decisionanalysisandquantifyingpatientvalues 333 31 Cost-effectivenessanalysis 350 32 Survivalanalysisandstudiesofprognosis 359 33 Meta-analysisandsystematicreviews 367 Appendix1 Levelsofevidenceandgradesofrecommendations 378 Appendix2 Overviewofcriticalappraisal 384 Appendix3 Commonlyusedstatisticaltests 387 Appendix4 Formulas 389 Appendix5 ProofofBayes’theorem 392 Appendix6 Usingbalancesheetstocalculatethresholds 394 Glossary 396 Bibliography 411 Index 425 Contributors ShobhinaG.Chheda UniversityofWisconsinSchoolofMedicineandPublic Health,Madison,Wisconsin,USA ElizabethIrish AlbanyMedicalCollege,NewYork,USA JohnE.Kaplan AlbanyMedicalCollege,NewYork,USA SandiPirozzo UniversityofQueensland,Brisbane,Australia ChristineS.Seibert UniversityofWisconsinSchoolofMedicineandPublic Health,Madison,Wisconsin,USA StevenR.Simon HarvardMedicalSchool,Boston,Massachusetts,USA LauraJ.Zakowski UniversityofWisconsinSchoolofMedicineandPublic Health,Madison,Wisconsin,USA vii Preface In1992duringaperiodofinnovativerestructuringofthemedicalschoolcur- riculumatAlbanyMedicalCollege,Dr.HenryPohl,thenAssociateDeanforAca- demicAffairs,askedmetodevelopacoursetoteachstudentshowtobecome lifelonglearnersandhowthehealth-caresystemworks.Thischargebecamethe focusofanewlongitudinalrequired4-yearcourseinitiallycalledCCCS,orCom- prehensiveCareCaseStudy.In2000,thenamewaschangedtoEvidence-Based Medicine. Duringthenext15years,aformidablecoursewasdeveloped.Itconcentrates on teaching evidence-based medicine (EBM) and health-care systems opera- tions to all medical students at Albany Medical College. The first syllabus was basedonacourseincriticalappraisalofthemedicalliteratureintendedforinter- nalmedicineresidentsatMichiganStateUniversity.Thiscorehasexpandedby incorporatingmedicaldecisionmakingandinformatics.Thebasisfortheorga- nizationofthebookliesintheconceptoftheeducationalprescriptionproposed byW.ScottRichardson,M.D. Thegoalofthetextistoallowthereader,whethermedicalstudent,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 thelinesinaresearchstudyandapplythatinformationtoyourpatients. For reasons I do not clearly understand, many physicians are “allergic” to mathematics.It seems that even the simplest mathematicalcalculations drive them to distraction. Medicine is mathematics. Although the math content in thisbookisonaprettybasiclevel,mostdailyinteractionwithpatientsinvolves someunderstandingofmathematicalprocesses.Wemaywanttodeterminehow muchbetterthepatientsittinginourofficewilldowithaparticulardrug,orhow tointerpretapatient’sconcernaboutanewfindingontheiryearlyphysical.Far more commonly, we may need to interpret the information from the Internet thatourpatientbroughtin.Eitherway,wearedealinginprobability.However,I haveendeavoredtokeepthemathassimpleaspossible. Thisbookdoesnotrequireaworkingknowledgeofstatisticaltesting.Themath islimitedtosimplearithmetic,andahandheldcalculatoristheonlycomputing ix

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Every effort has been made in preparing this publication to provide accurate and up-to-date information 29 Practice guidelines and clinical prediction rules. 320 on teaching evidence-based medicine (EBM) and health-care systems opera- (ACP) and the Evidence-Based Emergency Medicine group (w
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