中国在用电子血压计经临床准确性验证情况初步调查

Preliminary survey report on the clinical validation of in-use electronic sphygmomanometers in China

目的初步了解我国在用电子血压计经临床准确性验证的情况。方法本研究为横断面调查,根据地理位置和经济水平选择北京市、深圳市、石家庄市、大同市及石河子市作为本研究调查地区,从上述5个城市中分别选择1家三甲医院、2家社区卫生服务中心及20户拥有电子血压计的家庭,每家医院选择10台电子血压计,每家社区卫生服务中心选择5台电子血压计,每户家庭选择1台电子血压计,登记每台电子血压计的品牌、型号、生产企业、出厂日期等信息,同时收集使用者对所用电子血压计测量是否准确的主观判断结果及判断依据。根据血压计的品牌和型号,在Medaval、Stride BP、dabl Educational Trust、British and Irish Hypertension Society、American Medical Association和Hypertension Canada共6个电子血压计临床准确性验证登记网站以及Pubmed、中国知网数据库查询其是否经过独立的临床准确性验证。结果本研究共调查电子血压计200台,其中经独立临床准确性验证的比例仅为29.0%(58/200)。这一比例在三甲医院为46.0%(23/50),在社区卫生服务中心为42.0%(21/50),在家庭用户为14.0%(14/100),3组间比较差异有统计学意义(P<0.001)。三甲医院及社区卫生服务中心医生判断电子血压计测量准确性的依据主要为“是否定期校正”[41.0%(41/100)]和“与其他电子血压计对比”[20.0%(20/100)];家庭用户中,41.0%(41/100)的用户不清楚电子血压计的准确性,40.0%(40/100)的用户根据“与医院、社区对比”进行判断。结论我国在用电子血压计经独立临床准确性验证的比例较低。绝大多数电子血压计使用者包括医疗卫生专业人员,对电子血压计的临床准确性验证情况缺乏认识和了解。

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.