Clinical validation of MESI mTABLET BP according to ISO 81060-2:2018 + A1 + A2.

IF 1 4区医学 Q4 PERIPHERAL VASCULAR DISEASE

Blood Pressure Monitoring Pub Date : 2026-09-14 DOI:10.1097/MBP.0000000000000825

Jaka Strel, Metka Križič, Biljana Nikolova Stoilova, Ivan Pecev, Rebeka Novak, Matija Kiker, Tinkara Royal Mlinar

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引用次数: 0

Abstract

Objective: The objective of this study was to clinically validate the MESI mTABLET BP device in accordance with the protocol outlined in ISO 81060-2:2018 + A1 + A2.

Methods: A total of 127 adult participants were enrolled, of whom 36 were excluded. The final study sample consisted of 91 participants with upper arm circumferences ranging from 22 to 50 cm. Blood pressure measurements obtained with the MESI mTABLET BP were compared with reference auscultatory measurements performed simultaneously by two trained observers. A same-arm sequential method was used, in which each MESI mTABLET BP measurement was compared against the average of the preceding and subsequent reference measurements. The study was approved by the National Medical Ethics Committee of the Republic of Slovenia.

Results: The mean blood pressure difference between MESI mTABLET BP and the reference auscultatory method was 1.6 ± 4.3 mmHg for SBP and 1.9 ± 5.1 mmHg for DBP; hence, criterion 1 from the standard was fulfilled (required |mean| ≤5.00, SD ≤8.00 mmHg). Criterion 2 was also met, as the SD of average paired determinations per participant was ±3.56 mmHg for SBP and ±4.66 mmHg for DBP (required ≤6.76 and ≤6.68 mmHg, respectively).

Conclusion: The MESI mTABLET BP demonstrated clinical accuracy and reliability, and can hence be recommended for use in clinical and primary care settings in adult populations with upper arm circumferences between 22 and 50 cm, as validated in the present study.

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MESI mTABLET BP符合ISO 81060-2:2018 + A1 + A2标准的临床验证。

目的：本研究的目的是根据ISO 81060-2:2018 + A1 + A2概述的方案对MESI mTABLET BP装置进行临床验证。方法：共纳入127名成人受试者，其中36人被排除。最后的研究样本包括91名上臂周长在22到50厘米之间的参与者。用MESI mTABLET BP获得的血压测量值与由两名训练有素的观测者同时进行的参考听诊测量值进行比较。采用同臂顺序方法，将每次MESI mTABLET血压测量值与之前和随后的参考测量值的平均值进行比较。这项研究得到了斯洛文尼亚共和国国家医学伦理委员会的批准。结果：MESI mTABLET BP与参考听诊方法的平均血压差为收缩压1.6±4.3 mmHg，舒张压1.9±5.1 mmHg；因此，满足标准中的标准1（要求|平均值|≤5.00,SD≤8.00 mmHg）。标准2也得到满足，每位参与者的平均配对测定的SD为收缩压±3.56 mmHg，舒张压±4.66 mmHg（要求分别≤6.76和≤6.68 mmHg）。结论：MESI mTABLET BP具有临床准确性和可靠性，因此可以推荐用于临床和初级保健机构，上臂周长在22至50厘米之间的成人人群，正如本研究所证实的那样。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Blood Pressure Monitoring 医学-外周血管病

CiteScore

2.00

自引率

7.70%

发文量

110

审稿时长

>12 weeks

期刊介绍： Blood Pressure Monitoring is devoted to original research in blood pressure measurement and blood pressure variability. It includes device technology, analytical methodology of blood pressure over time and its variability, clinical trials - including, but not limited to, pharmacology - involving blood pressure monitoring, blood pressure reactivity, patient evaluation, and outcomes and effectiveness research. This innovative journal contains papers dealing with all aspects of manual, automated, and ambulatory monitoring. Basic and clinical science papers are considered although the emphasis is on clinical medicine. Submitted articles undergo a preliminary review by the editor. Some articles may be returned to authors without further consideration. Those being considered for publication will undergo further assessment and peer-review by the editors and those invited to do so from a reviewer pool.