Purpose

Clinical registries are used for quality management and clinical research. Due to the importance and implications of both aims, completeness and high quality of data are of paramount importance. However, this remains uncertain, as none of these registries have implemented independent monitoring. The aim of this study was to determine the accuracy and completeness of registry data o the example of the German Spine Society (DWG) registry.

Methods

In a prospective study, audits by a board-certified neurosurgeon were conducted at certified spine centers with mandatory registry input, a setting comparable to most existing registries worldwide. A 2-week period was analyzed, and any discrepancy between patients’ charts and the registry entry was evaluated. A median of 31 items per patient was evaluated including completeness and accuracy of data.

Results

Out of 17 centers willing to participate, 4 were still lacking any data entries. Even in the remaining 13 centers eligible for audits, 28.50% (95%-CI = [22.46–34.55]) of entries were finalized only after the audits were announced. Only 82.55% (95%-CI = [79.12–85.98]) of surgeries were documented, and on average 14.95% (95%-CI = [10.93–19.00]) of entries were not accurate with a wide variation (range; 6.21–27.44%) between centers. Aspects for improvement of the situation were identified.

Conclusion

Due to the high inaccuracy, the high number of centers lacking mandatory entries at all and the number of false entries, these data alert us to advocate unannounced audits and further measures to improve the situation. Data should not be used for the time being, since wrong conclusion will be drawn.

Graphic abstract

These slides can be retrieved under Electronic Supplementary Material.

中文翻译：

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脊柱注册表中数据的完整性和准确性：一项基于独立审核的研究。

目的

临床注册表用于质量管理和临床研究。由于这两个目标的重要性和意义，因此数据的完整性和高质量至关重要。但是，这仍然不确定，因为这些注册表都没有实施独立的监视。这项研究的目的是确定注册表数据的准确性和完整性，以德国脊柱学会（DWG）注册表为例。

方法

在一项前瞻性研究中，由董事会认证的神经外科医生在经过认证的脊椎中心进行了强制性注册表输入的审核，该设置与全球大多数现有注册表相当。分析了一个两周的时间，并评估了患者图表与注册表条目之间的任何差异。对每位患者的31项中位数进行了评估，包括数据的完整性和准确性。

结果

在愿意参​​加的17个中心中，有4个仍缺少任何数据条目。即使在其余13个有资格进行审核的中心中，也只有在宣布审核后才确定28.50％（95％-CI = [22.46–34.55]）条目。仅记录了82.55％（95％-CI = [79.12–85.98]）的手术，平均条目14.95％（95％-CI = [10.93-19.00]）的准确率存在较大差异（范围； 6.21） –27.44％）。确定了改善情况的方面。

结论

由于高度的不准确性，大量的中心根本没有强制性条目以及虚假的条目数量，这些数据提醒我们提倡进行突击审核，并采取进一步措施来改善这种状况。暂时不应使用数据，因为会得出错误的结论。

图形摘要

这些幻灯片可以在电子补充材料下找到。