Validation Study Registration Form

Transcription

1 TrUSt Validation Study Registration Form This form should be completed by the manufacturer or on behalf of the manufacturer. Study Investigator Details Name Address Mrs.Annemarie de Greef and Professor Andrew Shennan Division of Women's Health King's Health Partners, King's College London 10 Floor North Wing, St thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UNITED KINGDOM Test Device Details Brand Owner Brand JAPAN PRECISION INSTRUMENTS INC. NISSEI Model DSK-1011 Internal Model Number DSK-1011 Manufacturer JAPAN PRECISION INSTRUMENTS INC. OEM Q Initiator Manufacturer Details if "Other" If not initiated by the manufacturer, did the manufacturer agree to the study? Select the correct option on each of the following or, if required, complete the explanation beside "Other". Location Upper Arm Details if "Other" Method Oscillometry Details if "Other" Purpose Other Details if "Other" Clinic and self-measurement Operation Automatic Details if "Other" Automatic: Cuff inflation, deflation and blood pressure determination are fully performed by the device automatically; Semi-automatic: Blood pressure determination is performed automatically but cuff inflation and deflation need manual operation; Manual: Cuff pressure control and blood pressure determination are all performed by manual operation. Cuff details including arm circumference ranges (as recommended by the device manufacturer). Cuffs Small Adult: cm to cm Standard Adult: cm to cm Large Adult: cm to cm Other Universal Cuff: 22 cm to 42cm Wrist Cuff cm to cm Wrist Support Method Other features of the device (about 100 words). Memory function for two persons; indication of pulse pressure on LCD as well as graphical indication of blood pressure range. Ultra modern design with large easy to read display screen and incorporating the latest touch-switches method of operation. Agreement I agree to the publication of the results regardless of whether or not they are favourable to the device., y Signed Jr ( * =L -- ~~~&*~. Company Stamp or Seal Name Yasutomo Kimiura Date 21st July dabl8educational Trust Limited No reproduction of this document is permitted without the written authorisation of daweducational Trust Limited dabl Educational Trust Limited is a not-for-profit organisation. Carraig Court, George's Avenue, Blackrock, Co. Dublin, Ireland Tel info@dableducational.org Form DET1B Fax Web

2 ValidationStudyResultForm Please complete Section 1 to Section 3 of this form and return it to dabl Educational Trust with copies of the validationplots.therequirementsforeachofthesesectionsaredetailedbelowtherespectivetable. Brand Nissei StudyRef. DoNotFill Model DSK 1011 Investigator MrsAnnemariedeGreeff,ProfAndrewShennan Signed Date 3August2011 Section1:Methodology Familiarisation Abriefdescriptionofthefamiliarisationsessionshouldbeprovided.Anydifficultiesshouldbereported. Testmeasurementswereperformedbytrainedstudystaffbeforerecruitinganysubjects.Nodifficultieswereexperienced. Recruitment Thepopulationshouldbeoutlinedandthemethodofselectingthesampleshouldbedescribed.Difficultiesinrecruitment shouldbedescribedandhowtheywereovercome. Population General Detailsif Other Adults above the age of 25 years were recruited from outpatient clinics Kimberley Hospital Complex (Kimberley, South Africa). All patients had a doctor s appointment and none attended for validation purposes specifically/only. Procedure Twoobserverswithanindependentsupervisor Observersblindedfromeachother sreadingsandfromthedevicereadings The European Society of Hypertension International Protocol revision 2010 for the validation of blood pressure measuringdevicesinadultswasfollowedprecisely. Enter protocol adjustments, as necessary, when the study population is not general with sex, age and blood pressure distributionstatedindetail.theseadjustmentsshould bejustified,withreferences wherepossible.becausechildrenand adolescentshavewiderangeofbodysizeandbloodpressurelevels,thesamplesizeforavalidationstudyshoulddepend onthe studyinclusioncriteria. Thus,for example,a33 subject study wouldbeappropriateonly ifa narrowagerangeof childrenisincluded. Lowestpressurefordiastolicrangeis51mmHgandnot<50mmHg.WewereunabletofindasubjectwithaDBP<50mmHg withintheavailabletimeframeforthestudy,thereforesuchasubjectwasnotincluded. ThisformisintendedforuseonlyinconnectionwithbloodpressuremonitorvalidationstudiescarriedoutinaccordancewiththeprotocoloftheEuropean Society of Hypertension: O Brien E et al. European Society of Hypertension International Protocol revision 2010 for the Validation of Blood Pressure MeasuringDevicesInAdults.BloodPressMonit2010;15: dabl EducationalTrustLimited Noreproductionofthisdocumentispermittedwithoutthewrittenauthorisationofdabl EducationalTrustLimited dabl EducationalTrustLimitedisanot for profitorganisation. CarraigCourt,George savenue,blackrock,co.dublin,ireland Tel info@dableducational.org FormDET2B Fax Web

3 dabl EducationalTrust ESH IPValidationStudy Form3 StudyResults Page2of7 Note1: Section2:Results The data from Form 2 Subject Data for each subject should be analysed so that the results on this form can be completed.allreferencestoboxes refertovaluesobtainedfromalloftheForms2fromtherelevantsubjects. Table1:ScreeningandRecruitmentDetails ScreeningandRecruitment RecruitmentRanges TotalScreened TotalExcluded RangesComplete mmhg All OnRx Low < RangeAdjustment Arrhythmias DeviceFailure SBP Medium High > PoorQualitySounds CuffSizeUnavailable ObserverDisagreement Low < Distribution OtherReasons* TotalRecruited DBP Medium High > *ExplanationSummary 313 Box301: Box302: Box303: Box304: Box305: Box306: Box307: Box308: Box309: Box310: Box311: Box312: Box313: Boxes : Thetotalnumberofsubjectsscreened,regardlessofwhetherornottheywereincludedinthestudy. Thetotalnumberexcluded.ThisequalsthesumofBoxes303to311 ThenumberofsubjectsexcludedwithRangesCompletecircledinBox287(Form2foreachexcludedsubject). ThenumberofsubjectsexcludedwithRangeAdjustmentcircledinBox287. ThenumberofsubjectsexcludedwithArrhythmiascircledinBox287. ThenumberofsubjectsexcludedwithDeviceFailurecircledinBox287. ThenumberofsubjectsexcludedwithPoorQualitySoundscircledinBox287. ThenumberofsubjectsexcludedwithCuffSizeAvailabilitycircledinBox287. ThenumberofsubjectsexcludedwithObserverDisagreementcircledinBox287. ThenumberofsubjectsexcludedwithDistributioncircledinBox287. ThenumberofsubjectsexcludedwithOtherReasonscircledinBox287.Asummaryofthosereasonsmustbe providedinbox313. The total recruited equals the number screened (Box301) less the number excluded (Box302). This should equal33exceptinvalidationsinsomespecificpopulations. AsummaryofwhythosecountedinBox311wereexcluded.(Box288) Inacompletedstudyinageneraladultpopulation,thesumofBoxes314&315,Box316,thesumofBoxes317 &318,thesumofBoxes319&320,Box321andthesumofBoxes322&323musteachbebetween10and12. ThesumofBoxes314,318,319&323mustbeatmost4.ThesumofBoxes314to318andthesumofBoxes 319to323musteachbeexactly33.Studiesinspecificpopulationsmayhavedifferentrestrictionsandtotals. (Boxes219and220 Form2foreachincludedsubject) 2011dabl EducationalTrustLimited Noreproductionofthisdocumentispermittedwithoutthewrittenauthorisationofdabl EducationalTrustLimited

4 dabl EducationalTrust ESH IPValidationStudy Form3 StudyResults Page3of7 Boxes : Thenumberofsubjectsineachrangeonantihypertensivemedication.(Boxes207,219and220) 2011dabl EducationalTrustLimited Noreproductionofthisdocumentispermittedwithoutthewrittenauthorisationofdabl EducationalTrustLimited

5 dabl EducationalTrust ESH IPValidationStudy Form3 StudyResults Page4of7 Table2:SubjectDetails Sex Male:Female 16: Age(years) Range(Low:High) 25: Mean(SD) 51.7(15.8) 332 ArmCircumference(cm) Range(Low:High) 22: Mean(SD) 30.4(4.4) 334 Small x 335 cm CuffforTestDevice Standard x Large x cm cm Other cm Note2: Box330: Box331: Box332: Box333: Box334: Box335: Box336: Box337: Box338: Box339: Box340: Boxes : Boxes : WristCircumference(cm) (Wristdevicesonly) RecruitmentBP(mmHg) Range(Low:High) : 339 Mean(SD) ( ) 340 SBP DBP Range(Low:High) 101: Mean(SD) 151.2(29.2) : (18.0) 344 The values in Boxes refer only to the final recruited subjects, each of whom contributes SBP and DBP measurementsforanalysis.excludedsubjectsarenotincludedinanyofthisanalysis. Enter the numberofmales,acolonand the numberof females. Theyshouldtotal33 except invalidations in some specific populations. If the minimum requirements (10 for a general population) are not met, subjects mustbereplacedasnecessary.(box206) Entertheageoftheyoungestsubject,acolonandtheageoftheoldestsubjecte.g.31:74.Subjectsoutsidethe requiredrange(25andoverforageneralpopulation)arenotpermitted.(box205) Enterthemeanand,inparentheses,theSDofthesubjectages.Valuesshouldberoundedtoonedecimalplace e.g.52.3(11.9).(box205) Enterthesmallestarmcircumference,acolonandthelargestarmcircumferencee.g.24:34.(Box208) Enterthemeanand, in parentheses,thesdofthe subjectarmcircumferences.valuesshould berounded to onedecimalplacee.g.29.0(3.1).(box208) Ifasmallcuffwassupplied,enterthenumberofsubjectsonwhomitwasused.Ifitwasnotsupplied,enteran X.Enterthearmsizesforwhichitisrecommendedbesideit.(Box209) Enterthenumberofsubjectsonwhomastandard(ormedium)cuffwasused.Enterthearmsizesforwhichitis recommendedbesideit.(box209) Ifalargecuffwassupplied,enterthenumberofsubjectsonwhomitwasused.Ifitwasnotsupplied,enteran X.Enterthearmsizesforwhichitisrecommendedbesideit.(Box209) If a different size cuff was supplied, enter the number of subjects in whom it was used. If no such cuff was supplied,enteran X.Enterthearmsizesforwhichitisrecommendedbesideit.(Box209) Enterthesmallestwristcircumference,acolonandthelargestwristcircumferencee.g.15:22.(Applicableonly forwristdevices)(box210) Enterthemeanand,inparentheses,theSDofthesubjectwristcircumferences.Valuesshouldberoundedto onedecimalplacee.g.18.1(2.3).(applicableonlyforwristdevices)(box210) Enter the lowest pressure, a colon and the highest pressure from BPA measurements only e.g.104:180. (Boxes217and218) Enter the mean and, in parentheses, the SD of the subject pressures from BPA measurements only. Values shouldberoundedtoonedecimalplacee.g.140.4(20.3).(boxes217and218) 2011dabl EducationalTrustLimited Noreproductionofthisdocumentispermittedwithoutthewrittenauthorisationofdabl EducationalTrustLimited

6 dabl EducationalTrust ESH IPValidationStudy Form3 StudyResults Page5of7 Table3:Distribution Thissectionanalysesthedistributionofcomparativemeasurements. SBP DBP OverallRange(mmHg)Low:High 93: OverallRange(mmHg)Low:High 51: Low(<130mmHg) Low(<80mmHg) Medium(130mmHg 160 mmhg) Medium(80mmHg 100mmHg) High(>160mmHg) High(>100mmHg) Box345: Boxes : Box349 Box350: Boxes : Box354: Note3: Note4: Note5: Note6: MaximumDifference MaximumDifference 12 Enterthelowestpressure,acolonandthehighestSBPfromtheobservermeasurements.(Boxes281,283and 285) The observer measurements (three per subject) for SBP are categorised similarly to the recruitment ranges. Enterthecountsofmeasurementsfallingintoeachrange.Thesemusttotal99.(Boxes281,283and285) SubtractthesmallestvaluefromBoxes346to348fromthelargestoneandentertheresult. Enterthelowestpressure,acolonandthehighestDBPfromtheobservermeasurements.(Boxes282,284and 286) The observer measurements (three per subject) for DBP are categorised similarly to the recruitment ranges. Enterthecountsofmeasurementsfallingintoeachrange.Thesemusttotal99.(Boxes282,284and286) SubtractthesmallestvaluefromBoxes351to353fromthelargestoneandentertheresult. In order to ensure a uniform distribution, there must be at least 22 measurements and at most 44 measurements (Boxes346to348and351to353)ineachofthelow,mediumandhighrangesandthemaximumdifferences(Boxes 349and354)must beatmost19.if not,furtherrecruitmentwillbenecessary.subjectstobeexcluded willbethose whosepressuresdriftedfromrecruitmentpressures. TheoverallSBPrangemustbefrom 100mmHgto 170mmHgandtheoverallDBPrangemustbefrom 50mmHg to 120mmHg.Ifnot,furtherrecruitmentwillbenecessary.Subjectstobeexcludedwillbethelastrecruitedwithin therelevantranges. The minimum number of replacements should take place. If a subject is replaced for either of these reasons, circle DistributioninBox287ofForm2forthatsubject. In validations carried out in specific populations requiring more than 33 subjects but with similar blood pressure distributions, similar proportions should be used. If the blood pressure distribution in the specific population differs fromthestandarddistribution,ignorethistablebutcommentonthedistributioninthediscussion. Table4:ObserverDifferences Thissectionisforthedifferencesinpressuresbetweenthetwoobservers. 354 Observer2 Observer1 SBP(mmHg) DBP(mmHg) RangeLow:High 4:4 355 Mean(SD) 0.3(1.7) 357 4: (1.9) 358 Repeated Measurements Boxes Boxes Boxes359 Enterthelowestdifference,acolonandthehighestdifferencebetweentheobservers.Includethesignse.g. 3:+4.(Boxes247,249,251and253andBoxes248,250,252and254).Iftherangeisoutside 4:+4,thenthisisa violation.relevantsubjectsshouldbeexcluded,byreasonofobserverdisagreement,andreplaced. Enter the mean and, in parentheses, the SD of the observer differences. Values should be rounded to one decimalplacee.g.0.3(1.2).(boxes247,249,251and253andboxes248,250,252and254) Enterthenumberofmeasurementsthatwererepeatedintheincludedsubjectsbecauseobserversweremore than4mmhgapart. 2011dabl EducationalTrustLimited Noreproductionofthisdocumentispermittedwithoutthewrittenauthorisationofdabl EducationalTrustLimited

7 dabl EducationalTrust ESH IPValidationStudy Form3 StudyResults Page6of7 Table5:ValidationResults Part1 <5mmHg <10mmHg <15mmHg Grade1 Mean(mmHg) SD(mmHg) Pass Requirement Twoof Allof SBP Pass Achieved DBP Pass Part2 2/3<5mmHg 0/3<5mmHg Grade2 Grade3 Pass Requirement >24 <3 Note7: Box360: Box361: Box362: Box363: Achieved SBP 29 DBP Pass 374 Pass 378 Pass Pass Part3 Result Pass 380 Boxes : Box366: Box367: Box368: Box369: Boxes : Box372: Box373: Box374: Box375: Box376: Box377: Box378: Box379: Box380 Note8: Inorderforthedevicetopass,allrequirementsmustbefulfilled.Afailinanypartwillresultinanoverallfail. Enter the number of SBP differences (at most 99) between observer and device measurements falling within 5mmHg.(ThetotalnumberofBoxes273,275and277circledAinthe33subjects) Enter the number of SBP differences (at most 99) between observer and device measurements falling within 10mmHg.(ThetotalnumberofBoxes273,275and277circledAorBinthe33subjects) Enter the number of SBP differences (at most 99) between observer and device measurements falling within 15mmHg.(ThetotalnumberofBoxes273,275and277circledA,BorCinthe33subjects) IfBoxes360,361and362fulfilthePassrequirements,thenthisis Pass ;otherwise,itis Fail. Enter the mean and standard deviation respectively of the 99 SBP differences between observer and device measurements.(usedatafromcircledboxes261or267,263or269and265or271) EnterthenumberofDBP differences(atmost99) betweenobserveranddevicemeasurementsfallingwithin 5mmHg.(ThetotalnumberofBoxes274,276and278circledAinthe33subjects) EnterthenumberofDBP differences(atmost99) betweenobserveranddevicemeasurementsfallingwithin 10mmHg.(ThetotalnumberofBoxes274,276and278circledAorBinthe33subjects) EnterthenumberofDBP differences(atmost99) betweenobserveranddevicemeasurementsfallingwithin 15mmHg.(ThetotalnumberofBoxes274,276and278circledA,BorCinthe33subjects) IfBoxes366,367and368fulfilthePassrequirements,thenthisis Pass ;otherwise,itis Fail. Enter the mean and standard deviation respectively of the 99 DBP differences between observer and device measurements.(usedatafromcircledboxes262or268,264or270and266or272) Enterthenumberofsubjects(atmost33)withtwoorthreeoftheabsolutedifferencesbetweenobserverand devicesbpmeasurementswithin5mmhg.(box279is2or3) Enterthenumberofsubjects(atmost33)withnoneoftheabsolutedifferencesbetweenobserveranddevice SBPmeasurementswithin5mmHg.(Box279is0) IfBoxes372and373fulfilthePassrequirements,thenthisis Pass ;otherwise,itis Fail. IfBoxes363and374areboth Pass,thenthisis Pass ;otherwise,itis Fail. Enterthenumberofsubjects(atmost33)withtwoorthreeoftheabsolutedifferencesbetweenobserverand devicedbpmeasurementswithin5mmhg.(box280is2or3) Enterthenumberofsubjects(atmost33)withnoneoftheabsolutedifferencesbetweenobserveranddevice DBPmeasurementswithin5mmHg.(Box280is0) IfBoxes376and377fulfilthePassrequirements,thenthisis Pass ;otherwise,itis Fail. IfBoxes369and378areboth Pass,thenthisis Pass ;otherwise,itis Fail. IfBoxes375and379areboth Pass,thenthisis Pass ;otherwise,itis Fail. In validations carried out in specific populations requiring more than 33 subjects, proportionally equivalent passing criteriashouldbeused dabl EducationalTrustLimited Noreproductionofthisdocumentispermittedwithoutthewrittenauthorisationofdabl EducationalTrustLimited

8 dabl EducationalTrust ESH IPValidationStudy Form3 StudyResults Page7of7 Plots Discussion Section3:Closeout Includetheplotswiththisdocument.Confirmthattheycomplywiththerequirements SBP X axis: Range80mmHgto190mmHg Referencelinesat130mmHgand160mmHg Y axis: Range 30mmHgto30mmHg Referencelinesevery5mmHgfrom 15mmHgto15mmHg DBP X axis: Range30mmHgto140mmHg Referencelinesat80mmHgand100mmHg Y axis: Range 30mmHgto30mmHg Referencelinesevery5mmHgfrom 15mmHgto15mmHg No specific problems were encountered during validation and distribution conditions were fulfilled. Recruitment of subjectsinhighpressurerangesweremoredifficultandtimeconsumingthanthoseinmediumor low categories, which is commonly reported in validation studies. There was no subject with a diastolicpressure 50mmHg(ourlowestpressureinthisstudyis51mmHg),butitisclearfromthe aboveplotsthatthiswouldnotinfluencethefinalresultofthestudy.thisisthefirstvalidationof thenisseidsk 1011accordingtoarecognisedvalidationprotocol. Conclusion Theconclusionastowhetherthedeviceisaccurateforuseinthepopulationshouldbestated.Iftheresultsareparticularly sensitivetocorrectuse(e.g.mostwristdevices)thenthiscautionmustbestated. The Nissei DSK 1011 device achieves the standard required by the International Protocol revision 2010 and can be recommendedforclinicalorhomeuse. 2011dabl EducationalTrustLimited Noreproductionofthisdocumentispermittedwithoutthewrittenauthorisationofdabl EducationalTrustLimited

9 Systolic Plot Nissei DSK-1011 Diastolic Plot Nissei DSK-1011