120219 PMCID:PMC3366107
Twentyyearsoftelemedicineinchronicdiseasemanagementanevidence synthesis
RichardWootton
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Abstract
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Aliteraturereviewwasconductedtoobtainahighlevelviewofthevalueoftelemedicineinthe managementoffivecommonchronicdiseases(asthma,COPD,diabetes,heartfailure,hypertension).A totalof141randomisedcontrolledtrials(RCTs)wasidentified,inwhich148telemedicineinterventions ofvariouskindshadbeentestedinatotalof37,695patients.Thevalueofeachinterventionwas categorisedintermsoftheoutcomesspecifiedbytheinvestigatorsinthattrial,i.e.noattemptwasmade toextractacommonoutcomefromallstudies,aswouldberequiredforaconventionalmetaanalysis. Summarizingthevalueoftheseinterventionsshows,first,thatmoststudieshavereportedpositiveeffects (n =108),andalmostnonehavereportednegativeeffects(n =2).Thissuggestspublicationbias. Second,therewerenosignificantdifferencesbetweenthechronicdiseases,i.e.telemedicineseems equallyeffective(orineffective)inthediseasesstudied.Third,moststudieshavebeenrelativelyshort term(medianduration6months).Itseemsunlikelythatinachronicdisease,anyinterventioncanhave mucheffectunlessappliedforalongperiod.Finally,therehavebeenveryfewstudiesofcost effectiveness.Thustheevidencebaseforthevalueoftelemedicineinmanagingchronicdiseasesison thewholeweakandcontradictory.
Introduction
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Chronicillnesses,suchasasthma,COPD,diabetes,heartfailureandhypertensionrepresentasignificant burdenofdisease.BurdenofdiseaseismeasuredinDisabilityAdjustedLifeYears(DALYs),which reflectyearsoflifelostfromprematuredeathandyearsoflifelivedinlessthanfullhealth.Inhigh incomecountries,asthma,COPDanddiabetesrepresent11.1millionDALYsor7%ofthetotal DALYs.1 Aswellastheirsignificancefromtheperspectiveofthoseaffected,chronicdiseasesalso imposehugecostsonthehealthcaresystemsresponsibleformanagingthem.IntheUS,thedirecthealth carecostsforpatientswithasthma,diabetes,heartdiseaseandhypertensionwere$52.1billionin1996.2 Doestelemedicinehavearoleinthemanagementofchronicdiseases?Beforeconsideringthisquestion, itisworththinkingaboutwheretelemedicinewouldfitintothediseasemanagementprocess.Mostofus wouldimagine,apriori,thatcloserinvolvementofhealthcarestaffwithapatientwhohasoneormore chronicdiseaseswouldreducemorbidityandperhapsmortality.Thereissomeevidence,forexample, thatuseofnursecasemanagers(combinedwithapatienteducationprogramme)isefficacious.3 Useof casemanagersisoneaspectofprovidingintegratedcare,afashionabletermwitharatherelastic definition.Integratedcareiscommonlythoughtofasaprocessthatseekstoachieveseamlessand continuouscare,tailoredtotheindividualpatient'sneeds,andbasedonaholisticviewofthepatient. Thereareseveralsynonyms,suchasdiseasemanagement,caremanagement,managedcareand coordinatedcare.Integratedcareprogrammesseemtohavepositiveeffectsonthequalityofcare, althoughthewidelyvaryingdefinitionsandcomponentsmayleadtoinappropriateconclusionsbeing
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drawn.4 Howhastelemedicinebeenusedtosupportintegratedcareinchronicdiseasemanagement?Itsmain roleshavebeeninprovidingeducation(toimproveselfmanagement),inenablinginformationtransfer (e.g.telemonitoring),infacilitatingcontactwithhealthprofessionals(e.g.telephonesupportandfollow up)andinimprovingelectronicrecords.Thatis,telemedicinehasbeenusedinboththeprocessofcare andtheoutcomeofcare. Notethatthetermtelemedicinehasawidedefinitionmedicinepractisedatadistanceanda correspondinglywiderangeoftelemedicineapplicationshasbeentrialledinthemanagementofchronic diseases.Thetelemedicineinteractionshavebeenoftwotypes,eithertakingplaceinrealtime(e.g. videoconferencing)orasynchronously(e.g.storeandforwardtransmissionofdatafromahomeglucose meter).Monitoringapplicationshavebeenentirelyautomatic(e.g.passivemonitoringofactivityusing roomsensors)orhaverequiredthepatienttodosomething(e.g.transmitbodyweightvaluesusingthe buttonsonatelephone).Educationalapplicationshaveemployedspeciallydesignedhomedevices,or dependedonwebaccessfromPCsorsmartphones. Areviewconductedin2003concludedthattelemedicinelookedpromisingforchronicdisease management,butthatgoodqualitystudieswerescarceandthatthegeneralizabilityofmostfindingswas ratherlimited.5 Whathaschangedintheensuingnineyears?First,experimentationwithtelemedicinehas continuedapace.Therehasbeenacontinuedincreaseinthepublicationofpapersconcerning telemedicineandchronicdiseases(Figure1).Thenumbersofpapershasincreasedapproximatelyfive foldsince2003.Second,therehavebeensomesubstantialimplementations.Forexample,theVeterans AdministrationintheUShasreportedsome50,000patientsmanagedwithhometelecare.6 Despitethis enthusiasm,almostnothingisknownaboutthecosteffectivenessoftelemedicineinchronicdisease management. Figure1 Medlinepublicationsontelemedicineandfivechronicdiseases.There were1324publicationsbetween1990and2011. Costeffectivenessisacriticalmatterfortheadoptionofanynewtechniqueortechnologyintohealth care.Theconventionalapproachtoansweringquestionsaboutcosteffectivenessistosummarizethe resultsofrandomizedcontrolledtrials(RCTs)andproduceapooledestimateofeffect,byconductinga metaanalysis.Generally,theeffectofinterestistheQualityAdjustedLifeYear(QALY).Ifsuchan estimateforthecostofaQALYpassesanagreedthreshold(e.g.2535,000intheUKNHS),then widespreadimplementationoftheinterventionislikely.Ultimately,iftelemedicineisgoingtobeused onawidescaleinpublichealthcaresystems,itwillneedtopasstestssuchasthese.However,thereare significantdifficultiesintakingthisapproachinthepresentcontext.Crucially,therehavebeenveryfew studiesofcosteffectiveness,socalculatingapooledestimateisimpossible. Sinceestimatingthecosteffectivenessisunfeasiblebecauseofthelackofdata,somelesserassessment ofthevalueoftelemedicinemaybethebestthatcanbemanagedforthetimebeing.Again,the conventionalapproachisametaanalysis,examiningaquantitativeoutcomesuchasmortality, emergencydepartmentvisitsorlengthofstayinhospital.Suchanalyseshaveindeedbeenconductedfor specificoutcomesincertainchronicdiseases.Heretheproblemisthatthepublishedtrialshave employedawiderangeofoutcomemeasures,sothatapooledestimateofanyoneoutcomereducesthe
Methods
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Thefollowinginformationwasextractedfromeachofthestudies: Noofsubjects
Typeofpatient,e.g.diseaseandseverity Natureoftheintervention.Inaddition,detailswererecordedaboutwhethertherewas Routinevoicecontactwithapersonsuchasacasemanager,nursespecialistorpharmacist Voicecontactwithaninteractivevoiceresponse(IVR)system Videocontactwithahealthprofessional,e.g.videoconferencing Messagingwithahealthprofessional,e.g.usingemail,webmessagingoronlinechat Telemonitoring,e.g.automatictransmissionofdatasuchassymptomsorvitalsigns Duration(months) Primaryandotheroutcomes Result Overallvalueofintervention. Theoverallvalueoftheinterventionwasratedintermsoftheoutcomesspecifiedforthestudyin question,withtheeffectcategorisedona5pointscale,seeTable1. Table1 Categorisationofthevalueoftheintervention
Synthesis
Results
Identificationandselectionofstudies
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totalof1104patients.Outcomemeasurescommonlyemployedwerehospitaladmissionsandqualityof life. Indiabetes,trialsof39interventionswereidentifiedtherewerethreetrialsinwhichthedetailswere containedintworeportseach,seeTable5(seeonlineonlysupplementary data:http://jtt.rsmjournals.com/lookup/suppl/doi:10.1258/jtt.2012.120219//DC1).Thetrialsinvolveda totalof4970patients.OutcomemeasurescommonlyemployedwereHbA1c,qualityoflifeandself efficacy. Inheartfailure,trialsof61interventionswereidentifiedthereweresixtrialsinwhichthedetailswere containedintworeportseach,seeTable6(seeonlineonlysupplementary data:http://jtt.rsmjournals.com/lookup/suppl/doi:10.1258/jtt.2012.120219//DC1).Thetrialsinvolveda totalof16,388patients.Outcomemeasurescommonlyemployedweremortality,hospitaladmissions, qualityoflifeandhealthcarecosts. Inhypertension,trialsof17interventionswereidentifiedtherewere14RCTs,seeTable7(seeonline onlysupplementarydata:http://jtt.rsmjournals.com/lookup/suppl/doi:10.1258/jtt.2012.120219//DC1). Thesetrialsinvolvedatotalof4827patients.Outcomemeasurescommonlyemployedwereblood pressureandhealthcarecosts.
Sizeofthetrials
Effectestimates
Funnelplot
Potentialexplanatoryvariables
Themedianeffectinallfivechronicdiseaseswasweaklypositive.Intheindividualdiseases,themedian effectwasweaklypositiveforasthma,diabetes,heartfailureandhypertension,andpositiveforCOPD. TheeffectindifferentdiseasetypesissummarisedinFigure5.Therewerenosignificantdifferences betweenthedifferentdiseasetypes(KruskalWallisP=0.96). Figure5 Diseasetype.Theboundariesoftheboxesindicatethe25thand75th percentiles,andalinewithintheboxmarksthemedian.Thewhiskers (errorbars)aboveandbelowtheboxesindicatethe90thand10th percentiles.Potentialoutliersareshownindividually... TheeffectintrialsusingtelemonitoringisshowninFigure6therewasnosignificantdifferenceineffect betweeninterventionswhichemployedtelemonitoringandthosewhichdidnot.Theeffectintrialsusing routinevoicecontactisshowninFigure7therewasnosignificantdifferenceineffectbetween interventionswhichemployedroutinevoicecontactandthosewhichdidnot.Theeffectintrialsusing videoconferencingisshowninFigure8therewasnosignificantdifferenceineffectbetween interventionswhichemployedvideoconferencingandthosewhichdidnot. Figure6 Telemonitoring.BoxplotattributesasforFigure5
Figure7 Routinevoicecontact.BoxplotattributesasforFigure5
Figure8 Videoconferencing.BoxplotattributesasforFigure5
Synthesis
Inanorderedlogitregressionwithallpossiblepredictors,nonewassignificantexceptyearof publication(P=0.02).
Discussion
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Inatrialwithmultipleexperimentalarms,thequestionariseswhetheramultiplicityadjustmentis requiredtoreducetheprobabilityofafalsepositiveresult,i.e.withtwotreatmentarms,each interventiongroupwillbecomparedseparatelywiththesamecontrolgroup.Onepossibility,for example,wouldbetouseaBonferroniadjustment.However,theconsensusofopinionisthata multiplicityadjustmentwouldnotbenecessaryiftheaimofthetrialwastoanswerquestionsaboutthe efficacyofeachinterventionseparately,i.e.theinterpretationoftheresultsofonecomparisonhadno directbearingontheinterpretationoftheresultsoftheothers.29 Inthepresentcontext,themultiarm studiesfoundinthereviewinvestigatedinterventionssuchastelephonesupportandtelemonitoring, whichcanbeconsideredindependent.Thusamultiplicityadjustmentwasnotrequiredforthepresent analysis.
Systematicreviews
DuringtheidentificationofRCTsforthepresentstudy,atotalof22systematicreviewswasidentified concerningtheuseoftelemedicineinthefivechronicdiseasesofinterest.Inapproximatelyhalfofthese
reviews,theauthorsprovidedaqualitativesummaryofthevalueoftelemedicine,usuallyintheformof anarrativereviewnoneoftheseconcludednegatively,i.e.thattelemedicinewasunhelpfulinchronic diseasemanagement,seeTable8. Table8 Systematicreviewsreportingpooledestimatesofquantitativeoutcomes (NSdifferenceindicatesnodifferencebetweeninterventionand controlgroupsatP0.05significantimprovementindicatesthat there... Theotherhalfofthereviewsprovidedpooledestimatesofvariousquantitativeoutcomes.Therewere fourquantitativeoutcomeswhichwerepotentiallyapplicableinallfivediseases: 1. Qualityoflife 2. Emergencydepartmentvisits 3. Hospitalization 4. Mortality. Inaddition,therewerethreequantitativeoutcomeswhichwerespecifictodiabetes: 1. HbA1c 2. Severehypoglycaemia 3. Diabeticketoacidosis. Betweenthem,the12systematicreviewsprovided23pooledestimatesofeffect,ofwhich approximatelyhalfshowedtelemedicinetoprovidesignificantlybetteroutcomesthanthecontrol condition.Conversely,theotherhalfofthepooledestimatesshowedtelemedicinetobenobetterthan thecontrolcondition.Thisemphasisestheratherweakandunsatisfactoryconclusionswhichcanbe drawnfromthesystematicreviewspresentlyavailable.
Heartfailure
Ofthe22systematicreviewsidentified,thelargestnumber(9)concernedtheuseoftelemedicineinheart failure.Thesereviews,whichwerepublishedoveranineyearperiod,provideeightpooledestimatesof effect,allexceptonebeingsignificantlypositiveinfavouroftelemedicine.Ofallthechronicdiseases consideredinthepresentstudy,therefore,theevidencewouldappearmostfavourableforheartfailure. Indeed,theappearanceofanauthoritativeCochranereviewthatfavouredtheuseoftelemedicine (telephonesupportortelemonitoring)inheartfailure17 wouldnormallysignalacceptanceofefficacyby thescientificcommunityandpotentiallypavethewayforwidespreadtrialsofeffectiveness. Unfortunately,therehavebeentwosubsequentreports30,31 fromlarge,wellpoweredRCTswhichare contradictory,andatthetimeofwriting,weexpecttheCochranereviewtoberevisedandreissuedto reflectthis.
Overview
publicationbias.Thisissupportedbytheobservationthatmorerecentpublicationstendtoreportweaker effects.Publicationbiaswasalsosuggestedbytheasymmetricfunnelplotforthedataset.Whilethisis certainlyaplausibleexplanationoftheoverwhelminglypositivefindingsreported,itisnottheonly one.32 Thereislikelytobetrueheterogeneitybecauseofdifferencesbetweentheinterventionsand differencesbetweenthediseases. Thepresentreviewsuggeststhattherearenomajordifferencesinthevalueofthetelemedicine interventionbetweenthediseasetypes.Furthermore,neithertelemonitoringnorvideoconferencing appeartobesuperiortotelephonesupport.Moststudieshavebeenrelativelyshorttermwhich,inthe caseofchronicdiseases,mayweakentheirpowertodemonstrateaneffect.TheworkofSheaet al.,33 whoreported5yearfollowupinpatientswithdiabetes,demonstratesthatlongtermtelemedicine interventionsarepossible. Awiderangeofoutcomeshasbeenemployedinthetrialsreviewed.However,therehavebeenfew studiesinwhichcosteffectivenesshasbeenmeasured.TheworkbyHebertetal.34 reportingQALY datafortelemedicineinheartfailure,thereforerepresentsanexemplar. Onthebasisoftheworkreviewed,itisnotpossibletostatethattelemedicineofaparticulartypewillbe costeffectiveinthemanagementofoneormorechronicdiseases.Afternearly20yearsofrandomised trialswork,thisseemsbothsurprisinganddisappointing.Nonetheless,themajorityofthestudies conductedhavereportedpositiveeffectsintermsoftheoutcomesspecifiedinthosetrials.Thisraisesthe possibilitythatthebeneficialeffectreportedisnotduetotelemedicineitself,somuchastotheincreased attentionduetotheexperimentalintervention,i.e.thataHawthorneeffectisatleastpartlyresponsible. Futureworkshouldbedesignedtoseparatethetrueeffectsoftelemedicinefromputativeplacebo effects.
Limitations
Theevidencebaseforthevalueoftelemedicineinmanagingchronicdiseasesisonthewholeweakand contradictory.
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