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Joseph, Jeffrey I.

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van Helmond, Noud

Journal of Medical Internet Research

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Thomas Jefferson UniversityJefferson Digital CommonsDepartment of Anesthesiology Faculty Papers Department of Anesthesiology10-22-2018Blood Pressure Measurement Validation Off theCuff ? Comment on "A New Cuffless Device forMeasuring Blood Pressure: A Real-Life ValidationStudy".Noud van HelmondThomas Jefferson University, noud.van.helmond@jefferson.eduTimothy B. PlanteUniversity of VermontJeffrey I. JosephThomas Jefferson University, Jeffrey.joseph@jefferson.eduLet us know how access to this document benefits youFollow this and additional works at: https://jdc.jefferson.edu/anfpPart of the Anesthesiology CommonsThis Article is brought to you for free and open access by the Jefferson Digital Commons. The Jefferson Digital Commons is a service of ThomasJefferson University's Center for Teaching and Learning (CTL). The Commons is a showcase for Jefferson books and journals, peer-reviewed scholarlypublications, unique historical collections from the University archives, and teaching tools. The Jefferson Digital Commons allows researchers andinterested readers anywhere in the world to learn about and keep up to date with Jefferson scholarship. This article has been accepted for inclusion inDepartment of Anesthesiology Faculty Papers by an authorized administrator of the Jefferson Digital Commons. For more information, please contact:JeffersonDigitalCommons@jefferson.edu.Recommended Citationvan Helmond, Noud; Plante, Timothy B.; and Joseph, Jeffrey I., "Blood Pressure MeasurementValidation Off the Cuff? Comment on "A New Cuffless Device for Measuring Blood Pressure: AReal-Life Validation Study"." (2018). Department of Anesthesiology Faculty Papers. Paper 42.https://jdc.jefferson.edu/anfp/42Letter to the EditorBlood Pressure Measurement Validation Off the Cuff? Commenton “A New Cuffless Device for Measuring Blood Pressure: AReal-Life Validation Study”Noud van Helmond1, MD; Timothy B Plante2, MD, MHS; Jeffrey I Joseph1, DO1Department of Anesthesiology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, United States2Department of Medicine, Larner College of Medicine, University of Vermont, Burlington, VT, United StatesCorresponding Author:Noud van Helmond, MDDepartment of AnesthesiologySidney Kimmel Medical CollegeThomas Jefferson University1020 Locust StreetPhiladelphia, PA, 19107-6731United StatesPhone: 1 7168809732Email: noud.van.helmond@jefferson.eduRelated Articles: Comment on: https://www.jmir.org/2016/5/e85/ Comment in: http://www.jmir.org/2018/10/e12477/ (J Med Internet Res 2018;20(10):e10089)   doi:10.2196/10089KEYWORDScuffless blood pressure monitor; blood pressure monitor validation; hypertensionWe read with interest the validation study of the commerciallyavailable CheckMe blood pressure (BP) monitor by Schoot etal [1]. We agree with the authors that the development ofcuffless BP devices may improve rates of out-of-office BPmeasurement for adults with hypertension and that the value ofsuch devices depends on the devices’ accuracy. We feel thereare aspects of their report where clarification might be helpful.One of the reported strengths of the study is that it met EuropeanSociety of Hypertension International Protocol (ESH-IP)validation guidelines [2]. However, some aspects of the studydeviated from the ESH-IP, including obtaining of measurementsin varying anatomical positions. Usually, validation is performedin the manufacturer’s recommended position of measurement,which is typically in the same position as calibration [3].Additional information would be helpful to better understandthe performance characteristics from the device itself and toassess for bias introduced from protocol deviations.First, presenting correlation coefficients and scatterplots canhelp readers assess the relationship between measurements fromthe devices. Next, the authors present a relative difference inmean systolic BPs, which is near zero. Presenting mean absolutedifference between devices would be more informative to theaccuracy of the device [2]. A modified version of the ESH-IP’svalidation table is presented not in the usual numericalcategories. Calculating these categories, the CheckMe deviatesfrom the reference device by ≤5 mmHg, ≤10 mmHg, and ≤15mmHg for 16%, 62%, and 86% of the measures, respectively.These performance characteristics do not meet the threshold ofpassing ESH-IP’s first part of validation. Finally, contrary tothe description in the manuscript, we note that the referencedevice used has not undergone independent validation and itsaccuracy is not known [4]. Thus, it is difficult to interpret theaccuracy of CheckMe without understanding the performancecharacteristics of the reference device.We recognize that it is not possible to adhere to the ESH-IPwith novel cuffless BP-measuring devices, since the ESH-IPassumes that the tested monitor does not require user-specificcalibration. In response to the ongoing interest in cuffless BPmeasurement the Institute of Electrical and Electronics Engineers(IEEE) released a guideline specifically for the validation ofthese devices [5]. Because validation of a cuffless BP monitorimmediately after calibration at the same BP could artificiallyincrease its perceived accuracy [3], the IEEE protocol includesJ Med Internet Res 2018 | vol. 20 | iss. 10 | e10089 | p.1http://www.jmir.org/2018/10/e10089/(page number not for citation purposes)van Helmond et alJOURNAL OF MEDICAL INTERNET RESEARCHXSL•FORenderXvalidation measurements after changes in BP from thecalibration measurement and validation measurements after asignificant period since calibration.In conclusion, we encourage the authors to present additionalanalyses and results to improve the understanding of theCheckMe’s performance, and to follow up with a formalIEEE-protocol validation study. In the present study, the deviceis reported to be a Conformité Européenne-approved categoryIIa category medical device compliant with directive93/42/European Economic Community, but it did not meet thatdirective’s accuracy requirements (EN 1060-3). The CheckMehas United States Food & Drug Administration approval formeasurements of heart rate, oxygen saturation, temperature, andactivity, but not for measurement of systolic blood pressure [6].As the device does not meet ESH-IP accuracy criteria for bloodpressure in this study, we are concerned that it is available forsale directly to consumers and may place adults at undue harm. Conflicts of InterestNone declared.References1. Schoot TS, Weenk M, van de Belt TH, Engelen LJLPG, van Goor H, Bredie SJH. A New Cuffless Device for MeasuringBlood Pressure: A Real-Life Validation Study. J Med Internet Res 2016 May 05;18(5):e85 [FREE Full text] [doi:10.2196/jmir.5414] [Medline: 27150527]2. O'Brien E, Atkins N, Stergiou G, Karpettas N, Parati G, Asmar R, Working Group on Blood Pressure Monitoring of theEuropean Society of Hypertension. European Society of Hypertension International Protocol revision 2010 for the validationof blood pressure measuring devices in adults. Blood Press Monit 2010 Feb;15(1):23-38. [doi:10.1097/MBP.0b013e3283360e98] [Medline: 20110786]3. Boubouchairopoulou N, Kollias A, Chiu B, Chen B, Lagou S, Anestis P, et al. A novel cuffless device for self-measurementof blood pressure: concept, performance and clinical validation. J Hum Hypertens 2017 Jul;31(7):479-482. [doi:10.1038/jhh.2016.101] [Medline: 28124684]4. Medaval. 2017. Welch Allyn Vital Signs 300 Series URL: http://medaval.ie/device/welch-allyn-vital-signs-300-series/[accessed 2018-02-03] [WebCite Cache ID 6wxcESAO4]5. Institute of Electrical and Electronics Engineers. 2014 Aug 26. IEEE 1708-2014 Standard for Wearable Cuffless BloodPressure Measuring Devices URL: https://standards.ieee.org/standard/1708-2014.html [accessed 2018-09-26] [WebCiteCache ID 72jAQRSZx]6. U.S. Department of Health and Human Services Food and Drug Administration, Checkme Pro Health Monitor. 2015 Dec10. URL: https://www.accessdata.fda.gov/cdrh_docs/pdf15/K150869.pdf [accessed 2018-02-08] [WebCite Cache ID6x4IH3xMC]Edited by G Eysenbach; submitted 09.02.18; peer-reviewed by J Goris; comments to author 26.09.18; revised version received27.09.18; accepted 10.10.18; published 22.10.18Please cite as:van Helmond N, Plante TB, Joseph JIBlood Pressure Measurement Validation Off the Cuff? Comment on “A New Cuffless Device for Measuring Blood Pressure: A Real-LifeValidation Study”J Med Internet Res 2018;20(10):e10089URL: http://www.jmir.org/2018/10/e10089/ doi:10.2196/10089PMID:30348627©Noud van Helmond, Timothy B. Plante, Jeffrey I. Joseph. Originally published in the Journal of Medical Internet Research(http://www.jmir.org), 22.10.2018. This is an open-access article distributed under the terms of the Creative Commons AttributionLicense (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in anymedium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The completebibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license informationmust be included.J Med Internet Res 2018 | vol. 20 | iss. 10 | e10089 | p.2http://www.jmir.org/2018/10/e10089/(page number not for citation purposes)van Helmond et alJOURNAL OF MEDICAL INTERNET RESEARCHXSL•FORenderX

Blood Pressure Measurement Validation Off the Cuff? Comment on  A New Cuffless Device for Measuring Blood Pressure: A Real-Life Validation Study .

Helmond, N. van

Plante, T.B.

Joseph, J.I.

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Blood Pressure Measurement Validation Off the Cuff? Comment on "A New Cuffless Device for Measuring Blood Pressure: A Real-Life Validation Study".

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Blood Pressure Measurement Validation Off the Cuff? Comment on A New Cuffless Device for Measuring Blood Pressure: A Real-Life Validation Study .

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