Department of Neurosurgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Breisacher Str. 64, 79106, Freiburg, Germany.
BMC Musculoskelet Disord. 2022 Jan 31;23(1):104. doi: 10.1186/s12891-022-05055-9.
The common manual measurement technique of spinal sagittal alignment on X-rays is susceptible to rater-dependent variability, which has not been adequately considered in previous publications. This study investigates the effect of those variations in the characterization of patients receiving lumbar spondylodesis.
General alignment parameters on pre- and postoperative X-rays were evaluated by four raters in 43 prospectively sampled patients undergoing monolevel spondylodesis. The Intra-class Correlation Coefficient (ICC) for each rater pair and all raters together was calculated for inter-rater reliability. For the operation-induced change of the sagittal alignment in every patient the Wilcoxon test was applied to compare for each rater separately.
The ICCs were "good" (>0.75) to "excellent" (>0.9) for all raters together and for 45 of the 48 single rater pairs (93.75%). All revealed a significant increase of the addressed segmental lordosis and disc height and no significant change for spinopelvic parameters and sagittal vertical axis from pre- to postoperative. The lumbar lordosis showed a significant increase through the operation of +2.5° (p = 0.014) and +3.7° (p = 0.015) in two raters and no difference for the other ones (+2.1°, p = 0.171; -2.2°, p = 0.522).
The pre- to postoperative change of lumbar lordosis revealed different significance levels for different raters, although the ICCs were formally good. Accordingly, the evaluation by only one rater would lead to different conclusions. Due to this susceptibility of alignment measurements to rater-dependent variability, the exact evaluation process should be described in every publication and the consistency of significant results be validated through multiple raters.
The trial was approved by the local ethics committee and listed at the national clinical trials register ( DRKS00004514 , date of registration: 08/11/2012).
在 X 光片上进行脊柱矢状面排列的常用手动测量技术容易受到评估者之间的变异性的影响,而这在以前的出版物中没有得到充分考虑。本研究调查了这些变化对接受腰椎融合术的患者特征的影响。
对 43 例接受单节段融合术的前瞻性采样患者的术前和术后 X 光片进行了 4 名评估者的一般对齐参数评估。计算了每个评估者对之间以及所有评估者之间的组内相关系数(ICC),以评估组内可靠性。对于每位患者的手术引起的矢状面排列变化,分别应用 Wilcoxon 检验进行比较。
所有评估者的 ICC 均为“良好”(>0.75)至“优秀”(>0.9),48 个单一评估者对中的 45 对(93.75%)。所有评估者都发现,在 addressed segmental lordosis 和 disc height 方面有显著增加,在 spinopelvic 参数和矢状垂直轴方面没有显著变化。腰椎前凸在手术中增加了+2.5°(p=0.014)和+3.7°(p=0.015),在两位评估者中没有差异,而在其他评估者中则为+2.1°(p=0.171)和-2.2°(p=0.522)。
尽管 ICC 正式良好,但不同评估者对腰椎前凸的术前到术后变化的评估结果显示出不同的显著水平。因此,仅由一位评估者进行评估将导致不同的结论。由于这些对齐测量值容易受到评估者之间的变异性的影响,因此在每篇出版物中都应描述准确的评估过程,并通过多位评估者验证显著结果的一致性。
该试验得到了当地伦理委员会的批准,并在国家临床试验注册处(DRKS00004514,注册日期:2012 年 11 月 8 日)进行了注册。