Lyden P, Brott T, Tilley B, Welch K M, Mascha E J, Levine S, Haley E C, Grotta J, Marler J
University of California, San Diego.
Stroke. 1994 Nov;25(11):2220-6. doi: 10.1161/01.str.25.11.2220.
Despite the frequent use of clinical rating scales in multicenter therapeutic stroke trials, no generally acceptable method exists to train and certify investigators to use the instrument consistently. We desired to train investigators to use the National Institutes of Health Stroke Scale in a study of acute stroke therapy so that all examiners rated patients comparably.
We devised a two-camera videotape method that optimizes the visual presentation of examination findings. We then measured the effectiveness of the training by asking each investigator to evaluate a set of 11 patients, also on videotape. We tabulated the evaluations, devised a scoring system, and calculated measures of interobserver agreement among the participants in this study.
We trained and certified 162 investigators. We found moderate to excellent agreement on most Stroke Scale items (unweighted kappa > 0.60). Two items, facial paresis and ataxia, exhibited poor agreement (unweighted kappa < 0.40) and should be revised in future editions of the scale. Performance improved with video training compared with previous studies. Inclusion of the motor rating of the unaffected limbs in the total score did not affect reliability.
Video training and certification is a practical and effective method to standardize the use of examination scales. Two cameras must be used during the taping of patients to accurately present the clinical findings. This method is easily adapted to any study in which a large number of investigators will be enrolling patients at multiple clinical centers.
尽管临床评定量表在多中心中风治疗试验中经常使用,但目前尚无普遍可接受的方法来培训和认证研究人员以使其一致地使用该工具。我们希望在一项急性中风治疗研究中培训研究人员使用美国国立卫生研究院卒中量表,以便所有检查人员对患者的评分具有可比性。
我们设计了一种双摄像头录像方法,以优化检查结果的视觉呈现。然后,我们通过要求每位研究人员评估一组同样在录像中的11名患者来测量培训的效果。我们将评估结果制成表格,设计了一个评分系统,并计算了本研究参与者之间的观察者间一致性度量。
我们培训并认证了162名研究人员。我们发现,在大多数卒中量表项目上存在中度至高度一致性(未加权kappa>0.60)。两个项目,即面部轻瘫和共济失调,一致性较差(未加权kappa<0.40),应在该量表的未来版本中进行修订。与先前的研究相比,视频培训提高了表现。将未受影响肢体的运动评分纳入总分并不影响可靠性。
视频培训和认证是使检查量表使用标准化的一种实用且有效的方法。在拍摄患者时必须使用两个摄像头,以准确呈现临床发现。这种方法很容易适用于任何大量研究人员将在多个临床中心招募患者的研究。