无袖套血压测量设备的临床验证评论

医疗设备验证无袖套血压测量设备的临床验证评论（数字医疗/可穿戴设备/JMIR）作者：NoudvanHelmond、TimothyB.Plante、JeffreyI.Joseph许可：CCBY4.0(CreativeCommonsAttribution)【内容简介】JMIR发表的评论文章，对一种新型无袖套血压测量设备的实际验证研究进行批判性分析，CC-BY开放获取。（学术资料，仅供参考）【关键词】血压测量、无袖套设备、医疗设备验证、JMIR、心血管、可穿戴设备【分类】科技>医药卫生>临床医学——————————————————————————————BloodPressureMeasurementValidationOfftheCuff?Commenton"ANewCufflessDeviceforMeasuringBloodPressure:AReal-LifeValidationStudy".Helmond,N.van;Plante,T.B.;Joseph,J.I.2018,Article/Lettertoeditor(JournalofMedicalInternetResearch,20,10,(2018),pp.e10089)Doilinktopublisher:/10.2196/10089Versionofthefollowingfulltext:Publisher’sversionDownloadedfrom:/2066/199952Downloaddate:2026-03-16Note:Tocitethispublicationpleaseusethefinalpublishedversion(ifapplicable).LettertotheEditorBloodPressureMeasurementValidationOfftheCuff?Commenton“ANewCufflessDeviceforMeasuringBloodPressure:AReal-LifeValidationStudy”NoudvanHelmond1,MD;TimothyBPlante2,MD,MHS;JeffreyIJoseph1,DO1DepartmentofAnesthesiology,SidneyKimmelMedicalCollege,ThomasJeffersonUniversity,Philadelphia,PA,UnitedStates2DepartmentofMedicine,LarnerCollegeofMedicine,UniversityofVermont,Burlington,VT,UnitedStatesCorrespondingAuthor:NoudvanHelmond,MDDepartmentofAnesthesiologySidneyKimmelMedicalCollegeThomasJeffersonUniversity1020LocustStreetPhiladelphia,PA,19107-6731UnitedStatesPhonemail:noud.van.helmond@RelatedArticles:Commenton:/2016/5/e85/Commentin:/2018/10/e12477/(JMedInternetRes2018;20(10):e10089)doi:10.2196/10089KEYWORDScufflessbloodpressuremonitor;bloodpressuremonitorvalidation;hypertensionWereadwithinterestthevalidationstudyofthecommerciallyavailableCheckMebloodpressure(BP)monitorbySchootetal[1].WeagreewiththeauthorsthatthedevelopmentofcufflessBPdevicesmayimproveratesofout-of-officeBPmeasurementforadultswithhypertensionandthatthevalueofsuchdevicesdependsonthedevices’accuracy.Wefeelthereareaspectsoftheirreportwhereclarificationmightbehelpful.OneofthereportedstrengthsofthestudyisthatitmetEuropeanSocietyofHypertensionInternationalProtocol(ESH-IP)validationguidelines[2].However,someaspectsofthestudydeviatedfromtheESH-IP,includingobtainingofmeasurementsinvaryinganatomicalpositions.Usually,validationisperformedinthemanufacturer’srecommendedpositionofmeasurement,whichistypicallyinthesamepositionascalibration[3].Additionalinformationwouldbehelpfultobetterunderstandtheperformancecharacteristicsfromthedeviceitselfandtoassessforbiasintroducedfromprotocoldeviations.First,presentingcorrelationcoefficientsandscatterplotscanhelpreadersassesstherelationshipbetweenmeasurementsfromthedevices.Next,theauthorspresentarelativedifferenceinmeansystolicBPs,whichisnearzero.Presentingmeanabsolutedifferencebetweendeviceswouldbemoreinformativetotheaccuracyofthedevice[2].AmodifiedversionoftheESH-IP’svalidationtableispresentednotintheusualnumericalcategories.Calculatingthesecategories,theCheckMedeviatesfromthereferencedeviceby≤5mmHg,≤10mmHg,and≤15mmHgfor16%,62%,and86%ofthemeasures,respectively.TheseperformancecharacteristicsdonotmeetthethresholdofpassingESH-IP’sfirstpartofvalidation.Finally,contrarytothedescriptioninthemanuscript,wenotethatthereferencedeviceusedhasnotundergoneindependentvalidationanditsaccuracyisnotknown[4].Thus,itisdifficulttointerprettheaccuracyofCheckMewithoutunderstandingtheperformancecharacteristicsofthereferencedevice.WerecognizethatitisnotpossibletoadheretotheESH-IPwithnovelcufflessBP-measuringdevices,sincetheESH-IPassumesthatthetestedmonitordoesnotrequireuser-specificcalibration.InresponsetotheongoinginterestincufflessBPmeasurementtheInstituteofElectricalandElectronicsEngineers(IEEE)releasedaguidelinespecificallyforthevalidationofthesedevices[5].BecausevalidationofacufflessBPmonitorimmediatelyaftercalibrationatthesameBPcouldartificiallyincreaseitsperceivedaccuracy[3],theIEEEprotocolincludesJMedInternetRes2018|vol.20|iss.10|e10089|p.1/2018/10/e10089/(pagenumbernotforcitationpurposes)vanHelmondetalJOURNALOFMEDICALINTERNETRESEARCHXSL•FORenderXvalidationmeasurementsafterchangesinBPfromthecalibrationmeasurementandvalidationmeasurementsafterasignificantperiodsincecalibration.Inconclusion,weencouragetheauthorstopresentadditionalanalysesandresultstoimprovetheunderstandingoftheCheckMe’sperformance,andtofollowupwithaformalIEEE-protocolvalidationstudy.Inthepresentstudy,thedeviceisreportedtobeaConformitéEuropéenne-approvedcategoryIIacategorymedicaldevicecompliantwithdirective93/42/EuropeanEconomicCommunity,butitdidnotmeetthatdirective’saccuracyrequirements(EN1060-3).TheCheckMehasUnitedStatesFood&DrugAdministrationapprovalformeasurementsofheartrate,oxygensaturation,temperature,andactivity,butnotformeasurementofsystolicbloodpressure[6].AsthedevicedoesnotmeetESH-IPaccuracycriteriaforbloodpressureinthisstudy,weareconcernedthatitisavailableforsaledirectlytoconsumersandmayplaceadultsatundueharm.ConflictsofInterestNonedeclared.References1.SchootTS,WeenkM,vandeBeltTH,EngelenLJLPG,vanGoorH,BredieSJH.ANewCufflessDeviceforMeasuringBloodPressure:AReal-LifeValidationStudy.JMedInternetRes2016May05;18(5):e85[FREEFulltext][doi:10.2196/jmir.5414][Medline:27150527]2.O'BrienE,AtkinsN,StergiouG,KarpettasN,ParatiG,AsmarR,WorkingGrouponBloodPressureMonitoringoftheEuropeanSocietyofHypertension.EuropeanSocietyofHypertensionInternationalProtocolrevision2010forthevalidationofbloodpressuremeasuringdevicesinadults.BloodPressMonit2010Feb;15(1):23-38.[doi:10.1097/MBP.0b013e3283360e98][Medline:20110786]3.BoubouchairopoulouN,KolliasA,ChiuB,ChenB,LagouS,AnestisP,etal.Anovelcufflessdeviceforself-measurementofbloodpressure:concept,performanceandclinicalvalidation.JHumHypertens2017Jul;31(7):479-482.[doi:10.1038/jhh.2016.101][Medline:28124684]4.Medaval.2017.WelchAllynVitalSigns300SeriesURL:http://medaval.ie/device/welch-allyn-vital-signs-300-series/[accessed2018-02-03][WebCiteCacheID6wxcESAO4]5.InstituteofElectricalandElectronicsEngineers.2014Aug26.IEEE1708-2014StandardforWearableCufflessBloodPressureMeasuringDevicesURL:/standard/1708-2014.html[accessed2018-09-26][WebCiteCacheID72jAQRSZx]6.U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministration,CheckmeProHealthMonitor.2015Dec10.URL:/cdrh_docs/pdf15/K150869.pdf[accessed2018-02-08][WebCiteCacheID6x4IH3xMC]EditedbyGEysenbach;submitted09.02.18;peer-reviewedbyJGoris;commentstoauthor26.09.18;revisedversionreceived27.09.18;accepted10.10.18;published22.10.18Pleaseciteas:vanHelmondN,PlanteTB,JosephJIBloodPressureMeasurementValidationOfftheCuff?Commenton“ANewCufflessDeviceforMeasuringBloodPressure:AReal-LifeValidationStudy”JMedInternetRes2018;20(10):e100