Burnier Michel, Gasser Urs E
Service de Nephrologie et Consultation d'Hypertension, CHUV, Lausanne et Universite de Lausanne, and ClinResearch Ltd, Aesch, Switzerland.
Blood Press. 2008;17(2):104-9. doi: 10.1080/08037050801972881.
In clinical practice, end-digit preference is a common feature of blood pressure (BP) measurements. A wider use of electronic BP measuring machines could decrease this observer-linked artefact. The purpose of this analysis was to investigate the frequency of end-digit preference and to evaluate the impact of this observer bias on the assessment of the BP control induced in a large group of hypertensive patients treated with a calcium-channel blocker in whom BP was measured either with an automatic device or with a conventional sphygmomanometer.
Five hundred and four physicians participated in the study and 2199 patients were included. Treatment with lercanidipine was introduced at a dosage of 10 mg and titration to 20 mg was optional according to the physician's decision. BP was assessed at 4 and 8 weeks. To measure BP, physicians could use either a standard mercury sphygmomanometer or a pre-defined validated semi-automatic device (Microlife Average Mode, BP 3AC1-1, Microlife Corporation, Berneck, Switzerland) but they had to use the same method throughout the study. Physicians had to transcribe all BP measurements onto case report forms.
Very marked digit preferences were observed for both the conventional and the automatic measurements, being most prominent for the digit "0" (52% and 25%, respectively) followed by a preference for the digit "5" (19% and 15%). The use of the semi-automatic device reduces to a certain extent the frequency of the bias but the problem remains if physicians have to transfer the BP values onto case report forms. The end-digit preference has a major impact on the evaluation of a treatment effect and on the assessment of the percentage of patients achieving target BP in a population.
These results confirm that end-digit preference remains a serious bias in clinical practice. This bias has important consequences when evaluating the efficacy of a new antihypertensive drug. There is a need for training programmes and quality controls in clinical practice. The development of automatic systems with a direct transfer of BP values from the measuring device to the clinical chart or to the case report form should be encouraged.
在临床实践中,尾数偏好是血压(BP)测量的一个常见特征。更广泛地使用电子血压测量仪可能会减少这种与观察者相关的假象。本分析的目的是调查尾数偏好的频率,并评估这种观察者偏差对一大组接受钙通道阻滞剂治疗的高血压患者血压控制评估的影响,这些患者使用自动设备或传统血压计测量血压。
504名医生参与了该研究,纳入了2199名患者。以10mg的剂量开始使用乐卡地平治疗,根据医生的决定可选择滴定至20mg。在4周和8周时评估血压。为了测量血压,医生可以使用标准汞血压计或预定义的经过验证的半自动设备(Microlife平均模式,BP 3AC1-1,Microlife公司,瑞士伯内克),但在整个研究过程中他们必须使用相同的方法。医生必须将所有血压测量值转录到病例报告表上。
在传统测量和自动测量中都观察到非常明显的数字偏好,数字“0”最为突出(分别为52%和25%),其次是对数字“5”的偏好(19%和15%)。使用半自动设备在一定程度上降低了偏差的频率,但如果医生必须将血压值转录到病例报告表上,问题仍然存在。尾数偏好对治疗效果的评估以及对人群中达到目标血压的患者百分比的评估有重大影响。
这些结果证实,尾数偏好在临床实践中仍然是一个严重的偏差。这种偏差在评估新型抗高血压药物的疗效时具有重要影响。临床实践中需要培训计划和质量控制。应鼓励开发能够将血压值从测量设备直接传输到临床图表或病例报告表的自动系统。