Taylor R, Chidley K, Goodwin J, Broeders M, Kirby B
St Loyes School of Occupational Therapy, Exeter, UK.
J Hypertens. 1993 Nov;11(11):1275-82.
To assess the Accutracker II (version 30/23) ambulatory blood pressure monitor by nationally agreed protocols in order to resolve previous conflicting assessments, and to examine the feasibility of combining these protocols into one study.
The protocols of the Association for the Advancement of Medical Instrumentation (AAMI) and the British Hypertension Society (BHS) were used simultaneously.
Five normotensive subjects were used to assess interobserver variation; 30 subjects took part in the field evaluation and 85 in the laboratory evaluation. The latter subjects were selected to cover a wide range of blood pressures and differences in arm circumference.
Classification of device accuracy according to the criteria of the BHS and AAMI protocols.
Among 255 observations the mean +/- SD difference between blood pressure measurements by the Accutracker II and the observers was -2.2 +/- 0.8/-3.5 +/- 0.9 mmHg. There was a small but statistically significant difference between one device and the other two, but all three fulfilled the BHS criteria of 95% of measurements falling within 3 mmHg before and after use. In 30 24-h recordings > 80% of the programmed inflations produced valid recordings. Editing criteria accounted for the majority (55%) of invalid readings; weak Korotkoff sounds, imperfect electrocardiogram signals or movement artefact accounted for the remainder.
Version 30/23 of the Accutracker II fulfilled the AAMI criteria; using the BHS system, it was graded A for systolic and C for diastolic blood pressure. Although both protocols were readily combined into one study, they do not assess exactly the same aspects of blood pressure measurement. Previous conflicting evaluations could be due to differences in applying the protocols or may result from modifications in production models. Posture may affect the rating given by the BHS protocol. Until there is general international agreement on the method used to validate ambulatory blood pressure monitors, simultaneous use of both the BHS and AAMI protocols is recommended. In future assessments or investigational use of any similar instruments the model used should be described precisely.
通过国家认可的方案评估Accutracker II（30/23版本）动态血压监测仪，以解决先前相互矛盾的评估结果，并研究将这些方案合并到一项研究中的可行性。
同时采用美国医学仪器促进协会（AAMI）和英国高血压学会（BHS）的方案。
5名血压正常的受试者用于评估观察者间差异；30名受试者参与现场评估，85名参与实验室评估。后者的选择涵盖了广泛的血压范围和臂围差异。
根据BHS和AAMI方案的标准对设备准确性进行分类。
在255次观察中，Accutracker II与观察者测量的血压之间的平均±标准差差异为-2.2±0.8/-3.5±0.9 mmHg。一台设备与另外两台设备之间存在微小但具有统计学意义的差异，但所有三台设备均符合BHS标准，即使用前后95%的测量值落在3 mmHg范围内。在30次24小时记录中，超过80%的编程充气产生了有效记录。编辑标准占无效读数的大部分（55%）；其余的是柯氏音微弱、心电图信号不完美或运动伪影。
Accutracker II的30/23版本符合AAMI标准；使用BHS系统，收缩压分级为A，舒张压分级为C。虽然这两个方案很容易合并到一项研究中，但它们并未精确评估血压测量的相同方面。先前相互矛盾的评估可能是由于方案应用的差异，也可能是生产型号的修改所致。姿势可能会影响BHS方案给出的评级。在动态血压监测仪验证方法达成国际普遍共识之前，建议同时使用BHS和AAMI方案。在未来对任何类似仪器的评估或研究使用中，应精确描述所使用的型号。
