Preliminary survey report on the clinical validation of in-use electronic sphygmomanometers in China.
10.3760/cma.j.cn112148-20220531-00425
- Author:
Xiang Hui ZHANG
1
;
Yu Qing ZHANG
2
;
Rong HU
3
;
Ping SONG
4
;
Xu HAN
5
;
Shu Lin WEN
6
;
Heng GUO
7
;
Lin CHEN
8
;
Shao Bo XIAO
8
;
Yang Feng WU
9
Author Information
1. Peking University First Hospital, Beijing 100034, China Peking University Clinical Research Institute, Beijing 100091, China.
2. Department of Cardiology, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing 100037, China.
3. Department of Cardiology and Health Management Center of Beijing Anzhen Hospital Affiliated to Capital Medical University, Beijing 100029, China.
4. Shenzhen Association of Chronic Disease Prevention and Treatment, Shenzhen 518020, China.
5. Disease Management Center of the First Hospital of Hebei Medical University, Shijiazhuang 050031, China.
6. Datong Health Bureau Health Supervision Office, Datong 037000, China.
7. Shihezi University School of Medicine, Shihezi 832000.
8. Beijing Huijia Health Information Research Institute, Beijing 100190, China.
9. Peking University Clinical Research Institute, Beijing 100091, China.
- Publication Type:Journal Article
- MeSH:
Humans;
Blood Pressure Determination;
Cross-Sectional Studies;
Sphygmomanometers;
Hypertension/diagnosis*;
China;
Electronics;
Blood Pressure
- From:
Chinese Journal of Cardiology
2023;51(4):407-414
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To explore the percentage of in-use electronic sphygmomanometers independently validated clinically in China. Methods: We conducted a cross-sectional survey and Beijing, Shenzhen, Shijiazhuang, Datong, and Shihezi were selected according to the geographical location and economic level. In each site, one tertiary hospital, two community health centers, and 20 families with electronic sphygmomanometers in use were chosen. The information of electronic sphygmomanometers including brand, model, manufacturer and production date were obtained by the trained staff. Ten electronic sphygmomanometers from each hospital, five electronic sphygmomanometers from each community health center, and one electronic sphygmomanometer from each family were surveyed, and the user's subjective judgment results and judgment basis on the accuracy of the electronic sphygmomanometer measurement were collected. We searched six registration websites (Medaval, Stride BP, dabl Educational Trust, British and Irish Hypertension Society, American Medical Association and Hypertension Canada) and two research databases (PubMed and CNKI) for the clinical validation status of each electronic sphygmomanometer. Results: A total of 200 electronic sphygmomanometers were investigated in this study, of which only 29.0% (58/200) passed independent clinical validation. When stratified by users, the percentage of being clinical validated was 46.0% (23/50) for electronic sphygmomanometers in hospitals, 42.0% (21/50) for those in community health centers and 14.0% (14/100) for those in home use, respectively, and the proportions between the three groups were significantly difference (P<0.001). Doctors in tertiary hospitals and community health service centers judged the accuracy of electronic sphygmomanometers mainly on the basis of "regular correction" (41.0% (41/100)) and "comparison with other electronic sphygmomanometers" (20.0% (20/100)), while among home users, 41.0% (41/100) were not clear about the accuracy of electronic sphygmomanometers, and 40.0% (40/100) made the judgment by "comparison with the devices in hospitals". Conclusion: The clinical validation of in-use electronic sphygmomanometers in China is low. Most of users, including healthcare professionals, are not aware of clinical validation of electronic sphygmomanometers.
