Reliability of the National Institutes of Health Stroke Scale - Extension to non-neurologists in the context of a clinical trial

Reliability of the National Institutes of Health Stroke Scale - Extension to non-neurologists in the context of a clinical trial
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DOI:
10.1161/01.str.28.2.307
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发表时间:
1997-02-01
期刊:
影响因子:
8.3
通讯作者:
Samsa, GP
Samsa, GP
中科院分区:
医学1区
文献类型:
--
作者:
Goldstein, LB;Samsa, GP

文献摘要

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背景与目的通过对现场和录像患者的测试,确立了美国国立卫生研究院卒中量表(NIHSS)的可靠性。这种可靠性测试主要集中在神经科医生对量表的使用上。我们试图确定NIHSS在临床试验中被非神经科医生使用的可靠性。方法:在一项针对急性缺血性卒中患者的新疗法的随机试验开始之前,30名医师研究者(其中30%不是神经科医师)和29名非医师研究协调员在一次信息和培训会议上接受了使用NIHSS的培训,使用了标准化的患者检查录像。最初对4例患者进行评分。3个月后,同样的4名患者再次被转诊,提供了一种测量观察者内可靠性的方法。另外一组4名新患者在3个月后也进行了评分,与最初的4个评分一起,为评估观察者间的可靠性提供了数据。结果总的来说,28%的评分者有NIHSS的经验,22%的评分者以前使用过本试验中使用的录像带。决定系数(r(2))均大于。(1)神经科医生和其他类型的医生,(2)医生和研究协调员,(3)有NIHSS经验的评分者和没有NIHSS经验的评分者,(4)过去使用过录像带的评分者和从未看过录像带的评分者对同一4例病例的两种评分方法进行比较。计算得到的r(2)s大于。对于前4例病例的初始评分和4例新病例的后期评分,回归线的斜率均接近1,表明评分者的校准相似,类内相关系数为。93和。95,反映了高度的观察员内部和观察员之间的可靠性。这些数据将先前证明的NIHSS的可靠性扩展到非神经科医生,并表明各种医师调查员和护士研究协调员都可以快速培训,在实际临床试验的背景下可靠地应用该量表。
Background and Purpose The reliability of the National In stitutes of Health Stroke Scale (NIHSS) has been established through testing its use in live and videotaped patients. This reliability testing has primarily focused on the use of the scale by neurologists. We sought to determine the reliability of the NIHSS as used by non-neurologists in the context of a clinical trial.Methods In anticipation of the initiation of a randomized trial of a new therapy for patients with acute ischemic stroke, 30 physician investigators (30% of whom were not neurologists) and 29 non-physician study coordinators were trained in the use of the NIHSS at an informational and training conference using standardized videotaped patient examinations. A series of 4 patients were rated initially. After 3 months, the same 4 patients were rerated, providing a measure of intraobserver reliability. An additional series of 4 new patients were also rated after 3 months and, with the initial 4 ratings, provided data for assessment of interobserver reliability.Results Overall, 28% of the raters had previous experience with the NIHSS, and 22% had previously used the videotapes as used in the present trial. The coefficients of determination (r(2)) were each greater than .95 when the means of the two ratings of the same 4 cases were compared between (1) neurologists and other types of physicians, (2) physicians and study coordinators, (3) raters who had prior experience with the NIHSS and those without prior experience, and (4) raters who had used the videotapes in the past and those who had never viewed the tapes. The calculated r(2)s were greater than .98 for the initial rating of the first 4 cases and for the later rating of the 4 new cases, The slopes of the regression lines were all near 1, indicating that the raters were similarly calibrated, The intraclass correlation coefficients were .93 and .95, reflecting high levels of intraobserver and interobserver reliability.Conclusions These data extend the previously demonstrated reliability of the NIHSS to non-neurologists and show that both a variety of physician investigators and nurse study coordinators can be rapidly trained to reliably apply the scale in the context of an actual clinical trial.