Table Of Content

. ""^ Health Technology Assessment Information Service CoV^J •."•?' ANONPROFITAGENCY April 18, 1996 Ms.ConstanceConrad ProgramOfficer HealthCareFinancingAdministration BureauofPolicyDevelopment C4-10-07 7500SecurityBoulevard Baltimore,MD 21244-1850 DearMs.Conrad: Enclosedisthetechnologyassessment,"ElectricalStimulationforChronicWoundHealing."prepared underContractNo.500-95-0029. Twocopiesareenclosed. Tchoemmperniotr(fTihrsets)edrraefvtioefwetrhseianscsleusdsemdenatnwaadsvissoerntytgoroeuxtperfnoarlthriesviperowjeercst,(emxapneurftasctnoutreornsEofCRmIedistcaaflf)for devicesusedinelectricalstimulation,andanexpertinmeta-analysis. Copiesofreviewers'lettersare providedtoyouinadocumentseparatefromthetechnologyassessmentitself. Youwillalsofindachartoftasksperformedmatchedagainsttherequirementsforthisproject. Inits otBerarfisifgkeeisfcnitafnilogvslep)nlreoooswpfsionstoghafeltehtlteeeoccctthlrhnioecosaleHloeogasfytlittamhhsuelsCae8ats-rismeomnoe,FnnitttnhwaaonpncrdoiofjnhegtachtvAeedpmaesidrendiaiiosrtdtic.orhnaeWatdlieotsnhee,hravlEviiCecteeRrbsIaetwguoreufenfoeffwroferoedrriektndof.oopnremWraaeftdoiiorsgnmteasonatddnd(iptEtrhxieeeopcncauaortlseitdv-e tocarryouttheremainingadditionalservicesonthelistandwilldiscusswithyou,bytelephoneorin person,whetheryouwishthesecarriedoutandifso,theappropriatetimeframes. ECRIthanksyoufortheopportunitytohaveworkedonaprojectofnationalsignificance. Wethank youpersonallyforhavingmadetheexperiencepleasantaswellasmeaningful. Respectfullysubmitted, Jeffrey(C. Principa JCL/cb 28877l.WLE Enclosures cc: VivianCoates,ECRI MicheleThomas,ECRI 5200ButlerPike PlymouthMeeting,PA19462-1298,U.S.A. Telephone(610)825-6000 Fax(610)834-1275 04/18/96 12;18pm 288883.WGE Page TCoohnnettrhfaeoclttleoc5wh0in0no-gl9ot5ga-by0l0ea2sc9soertsroeslmtaehtenetsapotpfhreoeplcerocintatrtrieacacsltecssttpiieomcnuislfiacitnaitotinhoenfsofrmfawrloomurneSpdeocrhtte.asoluinbnCmg-i.2tte(dSctoopeH)CoFfA CorrespondingSection(s) RFPSpecification inReport Differencesineffectivenessamongvarioustypesof 5,6 electricalstimulation (C-2) Categoriesofpatientsforwhichthedifferenttypesof 5,6 stimulationareappropriate,thecourseoftreatment, settings(C-2) . Clinicalexpertiserequiredforuse(C-2) 3 Researchandanalysisofthepublishedliterature 4.5,6,7, (C-2.1) Opinionsofnationalmedicalprofessional organizations(C-2.1) Standardsofmedicalpractice(C-2.1) Assessmentofclinicaltreatmentstandards(C-2.1) Indicatorsforappropriatemedicaluse(C-2.1) 5,6 Safetyandefficacyfactors(C-2.1) 3,5,6,7,8 Professionalpracticenormspertainingtotheelectrical stimulationforwoundhealing(C-2.1) Clinicaladvantagesanddisadvantagesoftheelectrical 2,3 stimulationforwoundhealing(C-2.2) Opinionsofthegeneralmedicalcommunity(C-2.2) Opinionsofnationalprofessionalassociations(C-2.2) Synthesisofavailablescientificdatathatassessesthe 7,8 valueofthetechnologyincomparisonwithalternative modalities(C-2.2) Populationthatmayormaynotbenefitfromelectrical 4,5,6 stimulationforwoundhealing(C-22) R^TJl 04/18/96 I2;18pni 288883.WGE Page2 CorrespondingSection(s) RFPSpecification inReport Appropriatecaresettings(C-2.2) Safetyofelectricalstimulationforwoundhealing (C-2.2) Circumstancesforwhichelectricalstimulationfor 3,5,6,8 woundhealingisandisnotappropriate(C-2.2) Identifycostsassociatedwiththeuseofelectrical stimulationforwoundhealing(ECRIAlternative Proposal) Examineanystudiesofcosteffectivenessofelectrical 4.1 stimulationforwoundhealing(ECRIAlternative Proposal) R5?! AwnwpnnFiTAr;FNnY 04/18/96 12;18pni 288883.VVGE Page TCohnetrfaocltlo5w0i0n°g95ta-b0l0e2c9ortroeltahteesaptphreopcroinattreacstecstpieocnisficinattihoensfifnralomreSpeocrttiosnubCm-i2tte(dSctoopeH)CoFtA onthetechnologyassessmentofelectricalstimulationforwoundhealing. CorrespondingSection(s) RFPSpecification inReport Differencesineffectivenessamongvarioustypesof 5,6 electricalstimulation (C-2) Categoriesofpatientsforwhichthedifferenttypesof 5,6 stimulationareappropriate,thecourseoftreatment, settings(C-2) Clinicalexpertiserequiredforuse(C-2) Researchandanalysisofthepublishedliterature 4.5,6,7.8 (C-2.1) Opinionsofnationalmedicalprofessional organizations(C-2.1) Standardsofmedicalpractice(C-2.i) Assessmentofclinicaltreatmentstandards(C-2.1) Indicatorsforappropriatemedicaluse(C-2.1) 5,6 Safetyandefficacyfactors(C-2.1) 3,5,6,7, Professionalpracticenormspertainingtotheelectrical stimulationforwoundhealing(C-2.1) Clinicaladvantagesanddisadvantagesoftheelectrical 2,3 stimulationforwoundhealing(C-2.2) Opinionsofthegeneralmedicalcommunity(C-2.2) Opinionsofnationalprofessionalassociations(C-2.2) Synthesisofavailablescientificdatathatassessesthe 7,8 valueofthetechnologyincomparisonwithalternative modalities(C-2.2) Populationthatmayormaynotbenefitfromelectrical 4,5,6 stimulationforwoundhealing(C-2.2) r^ 04/18/96 12:18pm 288883.WGE Page2 CorrespondingSection(s) RFPSpecification inReport Appropriatecaresettings(C-2.2) Safetyofelectricalstimulationforwoundhealing (C-2.2) Circumstancesforwhichelectricalstimulationfor 3.5,6,8 woundhealingisandisnotappropriate(C-2.2) Identifycostsassociatedwiththeuseofelectrical stimulationforwoundhealing(ECRlAlternative Proposal) Examineanystudiesofcosteffectivenessofelectrical 4.1 stimulationforwoundhealing(ECRlAlternative Proposal) 17511 ElectricalStimulation fortheTreatmentof ChronicWounds )/Afntrpirlux1996ECRI. Duprlicationbyanymeansis2p8ro6h1i9bi6t.eWd,GE Pagei TableofContents 1.0 ExecutiveSummary 2.0 H22..e12alinPWghoPaursnoecdsessosfanWadnoduUlnUcdlecreHaretaaitloiinosnng ^^' 2.3 EvaluationandTherapiesforWoundHealing 10 2.3.1 Evaluation ^^ 2.3.2 GeneralTherapies 10 2.4 GuidelinesandEvidenceofPresentPracticePatterns 16 2.4.1 Consensus -"-^ 2.4.2 LackofConsensus 2.4.3 PracticePatterns ^^ 2.5 TTaabbllees2.1. SummaryofGuidelinesforWound•H•e•a•l•mg ^^ Therapy ^^ Table2.2. SummaryofTechnologyAssessmentsforWound HealingTherapies • 29 Table2.3. SummaryofReportsofPracticePatternsforthe TreatmentofChronicWounds 30 3.0 ElectricalStimulationforWoundHealing ^^ 3.1 BasicDescription 3.2 T33333...y..22222p.....e12345sDPAPoSilfuuprtlilEeensslcraeeetnlcddatCrCtCEuiiolurcnerrargcdrleteCnrSSnuttottrimiArmamApeuugppnllnpltaaeHitttccAiiiaapoocttpnniilAooiAapncnpnpsaspHdtlciiTaocrtnaeistaointosnmsentProtocols 333334446891 3.3 Safety ^^ 3.3.1 ReportsfromPublishedStudies ^-^ 3.3.2 ContraindicationsandWarningsfromProduct Literature 3.3.3 ECRIHealthDeviceAlertsDatabase 44 3.4 ManufacturersandCosts 3.5 TTaabbllees3.1. EEfxfaemcptsleosfEolfecPtrreicclailniSctalimSutluadtiieosnEovnaW\l'oua'ut'n'mdg'\tih'e''' Healing Table3.2. SThyenroappsieessoffoDriWreocutnCdurHreeanltin(gDC)Stimulation 51 Table3.3. SynopsesofPulsedCurrent(PC)Stimulation TherapiesforWoundHealing ^2 Table3.4. SStyinmouplsaetsioonfATlhteerranpaiteisngfoCruWrroeunntd(HACe)ahng 54 ©April1996Duplicationbyanymeansisprohibited. 9Rfi196.WGE Pageii Table3.5. S(yPnEoMpIs)esStoifmuPlualtsieodnETlheecrtarpoimeasgnfeotriWcoIunndudction Healing ^^ Table3.6. Manufacturers,Models,andDevice SpecificationsofElectricalStimulators 58 4.0 QualityofElectricalStimulationStudiesforChronicWound H4.e1alinDgatabasesandSearchStrategiesforElectricalioS"ti•'m'ulia't1-ion 4.2 PSotsusdiibelseConfoundingFactorsinWoundHealingStud•i:es // 4.2.1 StudyTypes Tl 4.2.2 ConfoundingSources '^ 4.2.3 OutcomeMeasures °^ 4.2.3.1 ObjectiveOutcomes:Percentageof PatientsCompletelyHealed 83 4.2.3.2 ObjectiveOutcomes:HealingRates 84 4.2.3.3 SubjectiveOutcomes 85 4.3 QualityofIndividualElectricalStimulationStudiesof WoundHealing 4.3.1 DirectCurrentControlledStudies ^^'^ 4.3.2 PulsedCurrentControlledStudies 89 4.3.3 AlternatingCurrentandTENSControlledStudies 92 4.3.4 PulsedElectromagneticInductionControlledStudies ... 93 4.3.5 ESStudyQuality:GeneralFindings 95 4.4 Tables ^^ Table4.1. AssessmentofQualityofDirectCurrent StimulationStudiesofWoundHealing 96 Table4.2. AssessmentofQualityofPulsedCurrent StimulationStudiesofWoundHealing 98 Table4.3. AssessmentofQualityofAlternatingCurrent StimulationStudiesofWoundHealing 100 Table4.4. AElsescetsrsommeangtneotfiQcuIanldiutcytoifonPuSltsueddiesofWound HeaUng ^^^ 5.0 ElectricalStimulationStudyDescriptionsandOutcomes 104 5.1 DirectCurrentStudies |^^ 5.1.1 UncontrolledStudies j^^ 5.1.2 ControlledStudies j°° 5.2 PulsedCurrentStudies |"^ 5.2.1 UncontrolledStudies 5.2.2 ControlledStudies |yj!J^9 5.3 AlternatingCurrent(andTENS)Studies 11^ 55..33..12 UCnocnotrnotlrloeldleSdtuSdtiuedsies |^^^^^ ©April1996Duplicationbyanymeansisprohibited. 286196.WGE Pageiii 5.4 PulsedElectromagneticInductionStudies 117 5.4.1 UncontrolledStudies H'^ 5.4.2 ControlledStudies H'^ 5.5 S5.p5i.n1alUCnocrodntSrtoilmlueldatStiuodniSetsudies 112200 5.5.2 ControlledStudy 120 55..76 TTOaanbbglloeeisn5g.1.StudOiuestcomesReportedbyInvestigatorsmr:D^i.r'ec"t' ' J20 CurrentStudiesofWoundHealing 122 Table5.2. OutcomesReportedbyInvestigatorsinPulsed CurrentStudiesofWoundHealing 124 Table5.3. OutcomesReportedbyInvestigatorsin AlternatingCurrentandTENSStudiesof WoundHealing 126 Table5.4. OEluetcctormoemsagRneeptoirctIenddubcytiInovneSsttiugdaiteosrsofiWnoPuulnsded Table5.5. HOeuatlcionmgesReportedbyInvestigatorsinSpi;nal ^^S CordStimulationStudiesofWoundHealing.... 129 Table5.6. OngoingStudiesofElectricalStimulationfor WoundHealing 130 6.0 QuantitativeAnalysisandMeta-AnalysesofOutcomesofElectrical ^ StimulationStudies _ 6.1 QuantitativeAnalysisofNormalizedWoundHealingRates: Theta(0)Values j^2 6.1.1 DefinitionandDescriptionofTheta •••• 1"^^ 6.1.2 ThetaOutcomesforIndividualElectricalStimulation Studies •• ^^^ 6.1.3 SummaryofNormaUzedHeahngRatesforElectrical StimulationStudies ^^^ 6.2 Meta-AnalysesofOutcomesofElectricalStimulationfor WoundHealing ^^^ 6.2.1 OverviewofMeta-AnalyticMethods 14U 6.2.2 Meta-AnalysisofNormalizedWoundHealingRates ... 142 6.2.2.1 OverallStudyAnalysis 142 6.2.2.2 AnalysisofStudyHeterogeneity 143 6.2.2.2.1 InfluenceofStudyDesign 143 6.2.2.2.2 InfluenceofPatient Characteristics,Wound Characteristics,orTreatment 144 6.2.3 Meta-AnalysisofCompleteWoundHealing 147 6.2.3.1 OverallStudyAnalysis 14' 6.2.3.2 AnalysisofStudyHeterogeneity 148 6.2.3.2.1 InfluenceofStudyDesign 148 ©April1996Duplicationbyanymeansisp2rao6hi1b9i6te.dW.GE