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类风湿关节炎抗风湿药物试验:标准化教学录像带对观察者依赖的结局测量可靠性的影响。

Rheumatoid arthritis antirheumatic drug trials: effects of a standardized instructional videotape on the reliability of observer-dependent outcome measures.

机构信息

University of Western Ontario, London.

出版信息

Inflammopharmacology. 1997;5(3):273-84. doi: 10.1007/s10787-997-0005-x.

Abstract

AIMS

A study was designed to assess the effects of a standardized instructional videotape on reducing interobserver variability for several commonly used observer-dependent outcome measures.

METHODS

During a single day, six rheumatologists independently examined six patients with rheumatoid arthritis (RA) in a predetermined order using a Latin square design, before and after viewing a standardized videotape demonstrating 13 examination techniques. Reliability coefficients were calculated based on the variance components of the analysis of variance (ANOVA) table.

RESULTS

Prestandardization reliability coefficients were >0.80 for all measures and remained above 0.80 following standardization.

CONCLUSIONS

It is usually assumed that serial measurement in clinical trials should be performed by the same assessor because of concern regarding interobserver variability. However, the high levels of prestandardization interobserver reliability observed in this study indicate that, for these variables, serial measurements in a clinical trial could be made by different assessors, assuming they were equally skilled. This observation has important implications for outcome measurement in RA clinical trials. Although high levels of prestandardization reliability precluded the demonstration of any significant effect, we speculate that the videotape might be effective in training less-experienced assessors. Reductions in observer variability have the potential to diminish sample size requirements for RA antirheumatic drug studies. The use of a videotape to achieve this goal offers cost and convenience advantages over one-on-one training procedures, and this method should be further assessed in less-experienced assessors.

摘要

目的

本研究旨在评估标准化教学录像带对减少几种常用观察者依赖的结局测量指标的观察者间变异性的影响。

方法

在一天内,六位风湿病学家使用拉丁方设计,按预定顺序先后检查六位类风湿关节炎(RA)患者,在观看演示 13 种检查技术的标准化录像带之前和之后进行。可靠性系数基于方差分析(ANOVA)表的方差分量计算。

结果

所有指标的标准化前可靠性系数均>0.80,标准化后仍保持在 0.80 以上。

结论

通常认为临床试验中的序列测量应该由同一位评估者进行,因为担心观察者间变异性。然而,本研究中观察到的高标准化前观察者间可靠性水平表明,对于这些变量,临床试验中的序列测量可以由不同的评估者进行,假设他们具有相同的技能。这一观察结果对 RA 临床试验中的结局测量具有重要意义。尽管高标准化前可靠性排除了任何显著效果的可能性,但我们推测录像带可能对培训经验较少的评估者有效。观察者变异性的减少有可能减少 RA 抗风湿药物研究的样本量要求。使用录像带实现这一目标具有成本和便利性优势,优于一对一的培训程序,并且应在经验较少的评估者中进一步评估这种方法。

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