Objectives The Simple Erosion Narrowing Score (SENS) is a simplification of the Sharp/van der Heijde score (SHS). Previous studies found SENS and SHS to have very similar measurement properties, but suggest that SENS has a lower discriminative ability that may result in reduced power. Therefore, we aimed to quantify the effect of using SENS rather than SHS on the power to show between-group differences in radiographic progression. Methods Using data from two clinical trials in rheumatoid arthritis (DRESS and BeSt), SENS was derived from the SHS. Criterion validity of the SENS in relation to the SHS was assessed by calculating the Spearman correlation. The power of both scores to show a difference between groups was compared using bootstrapping to generate 10.000 replications of each study. Then, the number of replications with a significant difference in progression (using ANCOVA adjusted for baseline scores) were compared. Results Correlations between SENS and SHS were all >0.9, indicating high criterion validity of SENS compared with SHS as a reference standard. There was one exception, the DRESS study showed a somewhat lower correlation for the change score at 18 months (0.787). The loss in power of SENS over SHS was limited to at most 19% (BeSt year 5). In addition, the difference in power between SENS and SHS is smaller at higher levels of power. Conclusion SENS appears to be a reasonable alternative to SHS, with only a limited loss of power to show between-group differences in radiographic progression.

中文翻译：

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使用简单侵蚀缩小评分或 Sharp/van der Heijde 评分对类风湿性关节炎临床试验检测放射学进展差异的功效的影响


目标 简单侵蚀缩小评分 (SENS) 是 Sharp/van der Heijde 评分 (SHS) 的简化。先前的研究发现 SENS 和 SHS 具有非常相似的测量特性，但表明 SENS 的辨别能力较低，可能会导致功率降低。因此，我们的目的是量化使用 SENS 而不是 SHS 对显示放射学进展组间差异的效果的影响。方法 使用两项类风湿关节炎临床试验（DRESS 和 BeSt）的数据，SENS 源自 SHS。通过计算 Spearman 相关性来评估 SENS 相对于 SHS 的标准有效性。使用自举法比较两个分数显示组间差异的能力，以生成每项研究的 10,000 次重复。然后，比较具有显着进展差异的重复次数（使用针对基线分数调整的ANCOVA）。结果SENS和SHS之间的相关性均为>0.9，表明与SHS作为参考标准相比，SENS具有较高的标准效度。有一个例外，DRESS 研究显示 18 个月时变化评分的相关性较低 (0.787)。 SENS 相对于 SHS 的功率损失最多被限制在 19%（BeSt 第 5 年）。此外，在功率级别较高时，SENS 和 SHS 之间的功率差异较小。结论 SENS 似乎是 SHS 的合理替代方案，仅显示放射学进展组间差异的能力有限。