Validation of a Remote Monitoring Blood Pressure Device in Pregnancy.
blood pressure
hypertension
maternal morbidity
preeclampsia
validation
Journal
American journal of hypertension
ISSN: 1941-7225
Titre abrégé: Am J Hypertens
Pays: United States
ID NLM: 8803676
Informations de publication
Date de publication:
21 05 2023
21 05 2023
Historique:
received:
09
08
2022
revised:
11
12
2022
accepted:
08
01
2023
medline:
23
5
2023
pubmed:
23
2
2023
entrez:
22
2
2023
Statut:
ppublish
Résumé
The Ideal Life Blood Pressure Manager measures blood pressure (BP) and automatically transmits results to the patient's medical record independent of internet access, but has not been validated. Our objective was to conduct a validation study of the Ideal Life BP Manager in pregnant women using a validation protocol. Pregnant participants were enrolled into three subgroups per the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization protocol: normotensive (systolic blood pressure (SBP) < 140 and diastolic blood pressure (DBP) < 90), hypertensive without proteinuria (SBP ≥ 140 or DBP ≥ 90), and preeclampsia (SBP ≥ 140 or DBP ≥ 90 with proteinuria). Two trained research staff used a mercury sphygmomanometer to validate the device, alternating sphygmomanometer, and device readings for a total of 9 measurements. Among 51 participants, the mean SBP and DBP differences and standard deviations between the device and the mean staff measurements for all participants were 1.7 ± 7.1 and 1.5 ± 7.0 mm Hg, respectively. The standard deviations of the individual participant's paired device and mean staff SBP and DBP measurements were 6.0 and 6.4 mm Hg, respectively. The device was more likely to overestimate rather than underestimate BP (SBP: mean difference = 1.67, 95% CI [-12.15 to 15.49]; DBP: mean difference = 1.51, 95% CI [-12.26 to 15.28]). Most paired readings had a difference of less than 10 mm Hg across averaged paired readings. The Ideal Life BP Manager met internationally recognized validity criteria in this sample of pregnant women.
Sections du résumé
BACKGROUND
The Ideal Life Blood Pressure Manager measures blood pressure (BP) and automatically transmits results to the patient's medical record independent of internet access, but has not been validated. Our objective was to conduct a validation study of the Ideal Life BP Manager in pregnant women using a validation protocol.
METHODS
Pregnant participants were enrolled into three subgroups per the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization protocol: normotensive (systolic blood pressure (SBP) < 140 and diastolic blood pressure (DBP) < 90), hypertensive without proteinuria (SBP ≥ 140 or DBP ≥ 90), and preeclampsia (SBP ≥ 140 or DBP ≥ 90 with proteinuria). Two trained research staff used a mercury sphygmomanometer to validate the device, alternating sphygmomanometer, and device readings for a total of 9 measurements.
RESULTS
Among 51 participants, the mean SBP and DBP differences and standard deviations between the device and the mean staff measurements for all participants were 1.7 ± 7.1 and 1.5 ± 7.0 mm Hg, respectively. The standard deviations of the individual participant's paired device and mean staff SBP and DBP measurements were 6.0 and 6.4 mm Hg, respectively. The device was more likely to overestimate rather than underestimate BP (SBP: mean difference = 1.67, 95% CI [-12.15 to 15.49]; DBP: mean difference = 1.51, 95% CI [-12.26 to 15.28]). Most paired readings had a difference of less than 10 mm Hg across averaged paired readings.
CONCLUSION
The Ideal Life BP Manager met internationally recognized validity criteria in this sample of pregnant women.
Identifiants
pubmed: 36810671
pii: 7049998
doi: 10.1093/ajh/hpad004
pmc: PMC10439484
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
341-347Subventions
Organisme : NHLBI NIH HHS
ID : K23 HL159331
Pays : United States
Informations de copyright
© The Author(s) 2023. Published by Oxford University Press on behalf of American Journal of Hypertension, Ltd. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
Références
Hypertens Pregnancy. 2009;28(3):348-59
pubmed: 19263287
Hypertens Pregnancy. 2012;31(1):131-9
pubmed: 21332327
Cleve Clin J Med. 2012 Jan;79(1):46-56
pubmed: 22219234
Obstet Gynecol. 2021 May 1;137(5):763-771
pubmed: 33831914
J Womens Health (Larchmt). 2022 Feb;31(2):261-269
pubmed: 34115529
J Perinat Neonatal Nurs. 2019 Apr/Jun;33(2):136-148
pubmed: 31021939
MMWR Morb Mortal Wkly Rep. 2019 May 10;68(18):423-429
pubmed: 31071074
PLoS One. 2020 Mar 11;15(3):e0229483
pubmed: 32160205
NCHS Data Brief. 2020 Apr;(364):1-8
pubmed: 32487290
NCHS Data Brief. 2017 Oct;(289):1-8
pubmed: 29155682
Obstet Gynecol. 2020 Jun;135(6):e237-e260
pubmed: 32443079
J Am Coll Cardiol. 2020 Oct 6;76(14):1690-1702
pubmed: 33004135
Curr Hypertens Rep. 2020 Aug 27;22(9):66
pubmed: 32852691
J Am Heart Assoc. 2020 Aug 4;9(15):e016174
pubmed: 32696695
Hypertension. 2018 Mar;71(3):368-374
pubmed: 29386350
J Racial Ethn Health Disparities. 2019 Aug;6(4):806-820
pubmed: 30887426
N Engl J Med. 2022 May 12;386(19):1781-1792
pubmed: 35363951
Curr Hypertens Rep. 2000 Oct;2(5):445-50
pubmed: 10995519
Lancet. 1986 Feb 8;1(8476):307-10
pubmed: 2868172
Circulation. 2013 Feb 12;127(6):681-90
pubmed: 23401113
Hypertension. 2018 Feb;71(2):326-335
pubmed: 29229741
J Am Heart Assoc. 2018 Sep 4;7(17):e009382
pubmed: 30371154
BMC Pregnancy Childbirth. 2021 Feb 19;21(1):153
pubmed: 33607957
Lancet. 2006 Apr 1;367(9516):1066-1074
pubmed: 16581405
Lancet. 2018 Mar 10;391(10124):949-959
pubmed: 29499873
Am J Perinatol. 2019 Jan;36(1):67-73
pubmed: 29906797
Semin Perinatol. 2017 Aug;41(5):258-265
pubmed: 28888263
JAMA Netw Open. 2020 Oct 1;3(10):e2018741
pubmed: 33001203