Web-Based Smartphone Algorithm for Calculating Blood Pressure From Photoplethysmography Remotely in a General Adult Population: Validation Study

Paul Holyoke, Karthika Yogaratnam, Elizabeth Kalles, Paul Holyoke, Karthika Yogaratnam, Elizabeth Kalles

Abstract

Background: Outside of a clinical setting, oscillometric devices make remote monitoring of blood pressure and virtual care more convenient and feasible. HeartBeat Technologies Ltd developed a novel approach to measuring blood pressure remotely after an initial blood pressure reading by a nurse using the conventional measurement method. Using a finger pulse oximeter, a photoplethysmogram wave is transmitted by Bluetooth to a smartphone or tablet. A smartphone app (MediBeat) transmits the photoplethysmogram to a server for analysis by a proprietary algorithm-the person's current blood pressure is sent back to the smartphone and to the individual's health care provider.

Objective: This study sought to determine whether the HeartBeat algorithm calculates blood pressure as accurately as required by the European Society of Hypertension International Protocol revision 2010 (ESH-IP2) for validation of blood pressure measuring devices.

Methods: ESH-IP2 requirements, modified to conform to a more recent international consensus statement, were followed. The ESH-IP2 establishes strict guidelines for the conduct and reporting of any validation of any device to measure blood pressure, including using the standard manual blood pressure instrument as a comparator and specific required accuracy levels for low, medium, and high ranges of blood pressure readings. The consensus statement requires a greater number of study participants for each of the blood pressure ranges. The validation of the accuracy of the algorithm was conducted with a Contec CMS50EW pulse oximeter and a Samsung Galaxy XCover 4 smartphone.

Results: The differences between the HeartBeat-calculated and the manually measured blood pressures of 62 study participants did not meet the ESH-IP2 standards for accuracy for either systolic or diastolic blood pressure measurements. There was no discernible pattern in the inaccuracies of the HeartBeat-calculated measurements.

Conclusions: The October 4, 2019 version of the HeartBeat algorithm, implemented in combination with the MediBeat app, a pulse oximeter, and an Android smartphone, was not sufficiently accurate for use in a general adult population.

Trial registration: ClinicalTrials.gov NCT04082819; https://ichgcp.net/clinical-trials-registry/NCT04082819.

Keywords: blood pressure measurement; hypertension; remote monitoring.

Conflict of interest statement

Conflicts of Interest: Two Contec pulse oximeters were supplied for the purposes of the study by HeartBeat Technologies Ltd. None of the authors have any association with, or have received any personal benefit from, HeartBeat Technologies Ltd.

©Paul Holyoke, Karthika Yogaratnam, Elizabeth Kalles. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 23.04.2021.

Figures

Figure 1
Figure 1
Contec CMS50EW.
Figure 2
Figure 2
Samsung Galaxy XCover 4.
Figure 3
Figure 3
Timeline of measurement of blood pressure for each participant.
Figure 4
Figure 4
Adapted version of the CONSORT flow diagram [16].
Figure 5
Figure 5
Bland-Altman plot of the differences between the Heartbeat-calculated measurements and the manual measurements of systolic blood pressure.
Figure 6
Figure 6
Bland-Altman plot of the differences between the Heartbeat-calculated measurements and the manual measurements of diastolic blood pressure.

References

    1. Lindsay P, Connor Gorber S, Joffres M, Birtwhistle R, McKay D, Cloutier L, Canadian Task Force on Preventive Health Care (CTFPHC) Recommendations on screening for high blood pressure in Canadian adults. Can Fam Physician. 2013 Sep;59(9):927–33, e393.
    1. Kaczorowski J, Chambers LW, Dolovich L, Paterson JM, Karwalajtys T, Gierman T, Farrell B, McDonough B, Thabane L, Tu K, Zagorski B, Goeree R, Levitt CA, Hogg W, Laryea S, Carter MA, Cross D, Sabaldt RJ. Improving cardiovascular health at population level: 39 community cluster randomised trial of Cardiovascular Health Awareness Program (CHAP) BMJ. 2011 Feb 07;342:d442. doi: 10.1136/bmj.d442.
    1. Nerenberg KA, Zarnke KB, Leung AA, Dasgupta K, Butalia S, McBrien K, Harris KC, Nakhla M, Cloutier L, Gelfer M, Lamarre-Cliche M, Milot A, Bolli P, Tremblay G, McLean D, Padwal RS, Tran KC, Grover S, Rabkin SW, Moe GW, Howlett JG, Lindsay P, Hill MD, Sharma M, Field T, Wein TH, Shoamanesh A, Dresser GK, Hamet P, Herman RJ, Burgess E, Gryn SE, Grégoire Jean C, Lewanczuk R, Poirier L, Campbell TS, Feldman RD, Lavoie KL, Tsuyuki RT, Honos G, Prebtani APH, Kline G, Schiffrin EL, Don-Wauchope A, Tobe SW, Gilbert RE, Leiter LA, Jones C, Woo V, Hegele RA, Selby P, Pipe A, McFarlane PA, Oh P, Gupta M, Bacon SL, Kaczorowski J, Trudeau L, Campbell NRC, Hiremath S, Roerecke M, Arcand J, Ruzicka M, Prasad GVR, Vallée Michel, Edwards C, Sivapalan P, Penner SB, Fournier A, Benoit G, Feber J, Dionne J, Magee LA, Logan AG, Côté Anne-Marie, Rey E, Firoz T, Kuyper LM, Gabor JY, Townsend RR, Rabi DM, Daskalopoulou SS, Hypertension Canada Hypertension Canada's 2018 guidelines for diagnosis, risk assessment, prevention, and treatment of hypertension in adults and children. Can J Cardiol. 2018 May;34(5):506–525. doi: 10.1016/j.cjca.2018.02.022.
    1. McAlister F A, Straus S E. Evidence based treatment of hypertension. Measurement of blood pressure: an evidence based review. BMJ. 2001 Apr 14;322(7291):908–11. doi: 10.1136/bmj.322.7291.908.
    1. Mercury versus nonmercury sphygmomanometers: a review of the comparative clinical effectiveness and guidelines. Canadian Agency for Drugs and Technologies in Health. 2012. [2018-06-25]. .
    1. Mena LJ, Félix Vanessa G, Ostos R, González Armando J, Martínez-Peláez Rafael, Melgarejo JD, Maestre GE. Mobile personal health care system for noninvasive, pervasive, and continuous blood pressure monitoring: development and usability study. JMIR Mhealth Uhealth. 2020 Jul 20;8(7):e18012. doi: 10.2196/18012.
    1. Plante TB, Urrea B, MacFarlane ZT, Blumenthal RS, Miller ER, Appel LJ, Martin SS. Validation of the instant blood pressure smartphone app. JAMA Intern Med. 2016 May 01;176(5):700–2. doi: 10.1001/jamainternmed.2016.0157.
    1. Plante TB, O'Kelly AC, Urrea B, Macfarlane ZT, Appel LJ, Miller III ER, Blumenthal RS, Martin SS. Auralife instant blood pressure app in measuring resting heart rate: validation study. JMIR Biomed Eng. 2018 Nov 21;3(1):e11057. doi: 10.2196/11057.
    1. Mazoteras-Pardo V, Becerro-De-Bengoa-Vallejo R, Losa-Iglesias ME, López-López Daniel, Palomo-López Patricia, Rodríguez-Sanz David, Calvo-Lobo C. Validation in the general population of the iHealth track blood pressure monitor for self-measurement according to the European Society of Hypertension International Protocol Revision 2010: descriptive investigation. JMIR Mhealth Uhealth. 2019 Mar 19;7(3):e13137. doi: 10.2196/13137.
    1. O'Brien E, Atkins N, Stergiou G, Karpettas N, Parati G, Asmar R, Imai Y, Wang J, Mengden T, Shennan A, Working Group on Blood Pressure Monitoring of the European Society of Hypertension European Society of Hypertension International Protocol revision 2010 for the validation of blood pressure measuring devices in adults. Blood Press Monit. 2010 Feb;15(1):23–38. doi: 10.1097/MBP.0b013e3283360e98.
    1. Stergiou G, Alpert B, Mieke S, Asmar R, Atkins N, Eckert Siegfried, Frick Gerhard, Friedman Bruce, Graßl Thomas, Ichikawa Tsutomu, Ioannidis John P, Lacy Peter, McManus Richard, Murray Alan, Myers Martin, Palatini Paolo, Parati Gianfranco, Quinn David, Sarkis Josh, Shennan Andrew, Usuda Takashi, Wang Jiguang, Wu Colin O, O'Brien Eoin. A universal standard for the validation of blood pressure measuring devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) collaboration statement. J Hypertens. 2018 Mar;36(3):472–478. doi: 10.1097/HJH.0000000000001634.
    1. CMS50EW Pulse Oximeter. Contec Medical Systems Co Ltd. 2020. [2021-04-15]. .
    1. Licence no.: 90629. Health Canada. [2021-03-22]. .
    1. K141362. U.S. Food and Drug Administration. [2021-03-22]. .
    1. K962655. U.S. Food and Drug Administration. [2021-03-22]. .
    1. Schulz Kenneth F, Altman Douglas G, Moher David, CONSORT Group CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. PLoS Med. 2010 Mar 24;7(3):e1000251. doi: 10.1371/journal.pmed.1000251.
    1. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Mar 08;1(8476):307–10.
    1. Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999 Jun;8(2):135–60. doi: 10.1177/096228029900800204.

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