EXPLICITDEFINITIONSTOIDENTIFYPREVENTABLEDRUG-RELATED MORBIDITYINANELDERLYPOPULATIONANDTHEIRUSEASAN INDICATOROFQUALITYINTHEMEDICATIONUSESYSTEM By RICHARDJOSEPHFARIS ADISSERTATIONPRESENTEDTOTHEGRADUATESCHOOL OFTHEUNIVERSITYOFFLORIDAINPARTIALFULFILLMENT OFTHEREQUIREMENTSFORTHEDEGREEOF DOCTOROFPHILOSOPHY UNIVERSITYOFFLORIDA 2001 Copyright2001 By RICHARDJOSEPHFARIS Thisdissertationisdedicatedtomylovelywife,LeanneandwonderfulsonSeth. Thank youforyourlove,supportandacceptance,regardlessofthecircumstances. Iwouldalsoliketodedicatethisdissertationto3familymemberswhopassedaway whileIwascompletingthisprocess;RichardJ.Faris,MargaretCalamandVirgilA. Minor. ThelateRichardJ.Farisismygrandfatherandnamesake. Iamtrulyproudto carryonhisname. ThelateMargaretCalamismygrandmother. Throughthesimple gameofcheckers,shetaughtmeearlythattherearenoeasyvictories. ThelateVirgilA. Minoristhefatherofmywifeandistrulymissed. Iwisheachofyoucouldbehereto shareinthisaccomplishment. ACKNOWLEDGMENTS Iwouldliketoacknowledgemydissertationchair,Dr.CharlesD.Hepler,forall histimeandpatiencewithmethroughthisprocess. Thedepthofmygratitudeisbeyond words. Ihavetrulylearnedalotandgrownasaperson. Ihavegainedamentoranda friendandIhopethatIcancarryonhishighstandardforresearchandwriting. Ithankthemembersofmysupervisingcommitteefortheirhardworkand patience. IthankDrs.RichardSegalandEarleneLipowskifortheirfriendshipand guidancethroughtheprogram. TheirsupporthasbeeninvaluableandsomethingIwill alwaystreasure. IthankDr.DavidMillerforshowingmethereismoretostatisticsthan mathematicalequations! Hehassparkedmylearningintheapplicationofmeasurement. IacknowledgetheAmericanFoundationforPharmaceuticalEducationfortheir supportofmyeducationthroughthefellowshipprogram. Ialsoacknowledgethesupport ofMerckandCompanyfortheirfinancialsupportofmyresearch. IwouldliketoacknowledgetheworkandfriendshipofDr.NeilMacKinnon. I havestoodonhisshouldersinthiswork. IwouldliketoacknowledgeDr.GeorgeMayzellandDeborahSwartwoodfor theirsupportandguidancefromthemanagedcareproviderperspective. IacknowledgeDebbieSirota,BrendaHudsonandJohnWegenkafortheirefforts withmydissertation. Eachplayedakeyroleinmydissertationinareasthatcouldhave causedgreatconfusionwithouttheirinvolvement. IV Dr.TimFolsehasbeenabrotherandfriendthroughoutthisprocess. Iamgladhe gottoshareinthisresearchwithme! Ihavehadtheblessingofwonderfulmentorsinmyprevioustraining. Dr. MickeyC.Smith,BruceScott,BobWilliams,andMikeFlagstadhaveinvestedtimeand efforttopreparemetobealeader. IwouldliketoacknowledgeWilliamGreene. Imiss workingwithandlearningfromhim! IthankDanielAshbyfortakingachanceonme-twice! Iappreciatehis friendship,effortandunwaveringsupportinmycompletionofthisdegree. Hehasgiven methelatitudetocompletethisimportantchapterinmylife. IwouldliketoacknowledgePatandLindaAmersonfortheirloveandsupportto myfamilythroughthisprocess. IhavebeenblessedtohaveGod'speoplecareforusas theyhave. Thanksgotomyfamilyforalltheirloveandsupport. ToMom,Dad,Nath,Bob, Tara,Jim,Mark,andSusanIsay,"itisdone"! Withoutthem,Iwouldnothaveachieved thishonor. Withoutfaith,Ihavenothing. TomyLordandSavior,thanksforgivingmethe mind,strength,andperseverancetofinishthisprocess. Ipraythattheworkdoneand futureopportunitieswillbringglorytoYourName. Last,butcertainlynotleast,Isaythankyoutomylovingwife,Leanne,andson, Seth. Theyhavetrulybeenaninspiration. Whenthetimesappeareddarkandthetrail withoutend,theyweretheretoencourage. LeannedeservesthishonorfarmorethanI do. Iwishhernamecouldreplacemine. TABLEOFCONTENTS page ACKNOWLEDGMENTS iv ABSTRACT xi CHAPTERS 1INTRODUCTION 1 TheNeedfortheStudy 1 ProblemStatement 4 StudyObjectives 5 ResearchQuestions 5 ResearchQuestion1 5 ResearchQuestion2 6 ResearchQuestion3 6 ResearchQuestion4 6 ResearchQuestion5 6 ResearchQuestion6 6 ResearchQuestion7 6 2REVIEWOFLITERATUREANDFRAMEWORK 7 MedicationUse 7 ImpactofDrug-RelatedMorbidity 8 Cost 8 Quality 9 Access 10 PreventabilityofDrug-RelatedMorbidity 10 QualityAssessmentandImprovement 12 Structure,ProcessandOutcome 13 RootCauseAnalysis 14 TheMedicationUseSystem 15 DefiningandMeasuringDrug-RelatedMorbidity 16 AdverseDrugReactions 16 MedicationErrors 19 AdverseDrugEvents 20 Drug-RelatedMorbidity 21 vi StudyPopulations 23 Measurement 24 Implicit 24 StructuredImplicit 25 Explicit 26 UseofComputerDatabases 27 Validity 29 TriarchicValidity 30 Messick'sValidityFramework 31 PreventableDrug-RelatedMorbidityandValidity 33 NumberofMedications 33 NumberofPrescribers 34 CardiovascularDrugs 34 Gender 34 NumberofDiagnoses 34 Age 34 HealthCareResourceUtilizationandCost 35 3METHODOLOGY 36 Introduction 36 PhaseI:DefiningPreventableDrug-RelatedMorbidity 36 DelphiPanel 36 MacKinnon'sDefinitions 37 PhaseII:OperationalizingDefinitions 38 MedicalEventCoding 39 MedicationCoding 40 PhaseIII:MeasurementofPreventableDrug-RelatedMorbidityandValidity 41 StudyPeriodandPopulation 41 ManagedCareDatabase 42 DataFields 42 StudyVariables 44 Preventabledrug-relatedmorbidity 44 Riskfactors 44 Healthcareresourceuseandcosts 44 PhaseIV:RootCauseAnalysis 45 StatisticalAnalysis 46 PreventableDrug-RelatedMorbidity 46 FactorsAssociatedWithValidity 46 Riskfactorsasconfirmatoryhypotheses 46 Resourceuseasconfirmatoryhypotheses 47 PatternofCareandOutcomeAnalysis 48 DaysBetweenthePatternofCareandOutcome 48 Process-To-OutcomeValue 50 vn 4RESULTS 51 Overview 51 GeriatricMedicineExpertPanel 51 Mnemonics 52 MacKinnon'sDefinitionsAcceptedbythePanel 52 MacKinnon'sRejectedDefinitions 53 DelphiPanelSurveyResults 55 IndividualPanelMemberVotingResults 56 DisqualificationofPanelMember 57 OperationalizationofDefinitions 58 MedicalEventCoding 58 PhysicianReviewofCodes 59 PreventableDrug-RelatedMorbidityMeasurement 59 StudyPopulation 59 PreventableDrug-RelatedMorbidity 59 PatternofCareandOutcomeMeasurement 60 DaysBetweenPatternofCareandOutcome 62 AdjustedDaysforPreventableDrug-RelatedMorbidity 63 PatientsWiththePatternofCareAfterAdjustment 65 Process-To-OutcomeValue 65 ConfirmatoryHypotheses 66 RiskFactors 66 ResourceUtilizationandCost 68 RootCauseAnalysis 68 5DISCUSSION 70 Introduction 70 GeriatricMedicineExpertPanel 70 ReplicationofMacKinnon'sWork 70 Consensus-ApprovedDefinitions 71 Evidence-BasedMedicineandthePanel 72 PanelDevelopedExplicitDefinitionsVersusImplicitJudgement 73 ThePanelandPreventabilityFramework 73 Operationalization 75 Measurement 75 PrevalenceofPreventableDrug-RelatedMorbidity 75 ComparisonofPDRMDetectionWithMacKinnon'sStudy 76 DefinitionsWithNoEventsScreenedPositive 78 PatternofCareandOutcomeAssessment 79 Process-To-OutcomeValue 80 DefinitionsWithaLowPTOV 82 PreventableDrug-RelatedMorbidityasanExtensionofDrugUseEvaluation 83 ValidityofaMeasureofPreventableDrug-RelatedMorbidity 85 EvidentiaryBasisforInterpretation 85 viii 1 Faceandcontentvalidity 85 Riskfactors 86 Resourceuse 86 EvidentialBasisforUse 87 Rootcauseanalysis 88 ConsequentialBasisforInterpretation 89 ConsequentialBasisforUse 90 Conclusion 91 PotentialLimitations 93 SignificanceofStudy 95 TheoreticalContribution 96 ContributiontoHealthCare 97 ContributiontotheProfessionofPharmacy 98 FutureAreasforStudy 98 APPENDICIES A:GERIATRICMEDICINEEXPERTPANELMEMBERS 100 B:INITIALMAILINGANDINSTRUCTIONSTOTHEDELPHIPANEL 101 C:ROOTCAUSEANALYSISEXPERTPANEL 104 D:FINALPREVENTABLEDRUG-RELATEDMORBIDITYDEFINITIONS 105 E:MNEMONICSFORCONSENSUS-APPROVEDDEFINITIONS 114 F:ALPHABETICALMNEMONICLIST 115 G:NUMBEROFPATIENTSWITHEACHPDRMDEFINITION 117 H:PDRM,PATTERNOFCAREONLY,ANDOUTCOMEONLY 119 I:CUT-OFFDAYSFORPDRMDEFINITIONSBASEDONMETHOD 121 J:PATTERNOFCAREONLYMEASURESBASEDON95%CUT-OFFVALUE..122 K:CONGESTIVEHEARTFAILURECAUSE-AND-EFFECTDIAGRAM 123 L:GASTROINTESTINALCAUSE-AND-EFFECTDIAGRAM 125 M:MYOCARDIALINFARCTIONCAUSE-AND-EFFECTDIAGRAM 127 N:MISCELLANEOUSCAUSE-AND-EFFECTDIAGRAM 129 O:CONSULTANTANALYSISOFROOTCAUSEANALYSIS 13 P:MACKINNON'STOP12DEFINITIONS 135 ix Q:FARIS'TOP10DEFINITIONS 138 R:PROCESS-TO-OUTCOMEVALUEAFTERADJUSTMENTFORNDPO 140 LISTOFREFERENCES 141 BIOGRAPHICALSKETCH 152