Department of Neurosurgery, Klinikum rechts der Isar, Technical University Munich, Ismaninger Str. 22, 81675, Munich, Germany.
Eur Spine J. 2020 Jun;29(6):1453-1461. doi: 10.1007/s00586-020-06342-6. Epub 2020 Mar 4.
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.
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.
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.
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. These slides can be retrieved under Electronic Supplementary Material.
临床注册用于质量管理和临床研究。由于这两个目的都非常重要且影响深远，因此数据的完整性和高质量至关重要。然而，目前尚不清楚这些注册中心是否已经实施了独立监测。本研究旨在以德国脊柱学会（DWG）注册中心为例，确定注册数据的准确性和完整性。
在一项前瞻性研究中，由一名经过董事会认证的神经外科医生在具有强制性注册输入的认证脊柱中心进行审核，这种设置与全球大多数现有注册中心相似。分析了两周的时间，并评估了患者图表与注册表条目的任何差异。对每位患者评估了中位数为 31 项内容，包括数据的完整性和准确性。
在愿意参与的 17 个中心中，有 4 个中心仍然没有任何数据条目。即使在其余 13 个有资格进行审核的中心中，也只有 28.50%（95%CI=[22.46-34.55]）的条目是在宣布审核后才最终完成。只有 82.55%（95%CI=[79.12-85.98]）的手术被记录，平均有 14.95%（95%CI=[10.93-19.00]）的条目不准确，且各中心之间的差异很大（范围为 6.21%-27.44%）。已经确定了改善这种情况的方法。
由于准确性不高、许多中心完全缺乏强制性条目以及虚假条目的数量，这些数据提醒我们倡导进行突击审核，并采取进一步措施来改善这种情况。目前不应使用这些数据，因为这将得出错误的结论。这些幻灯片可以在电子补充材料中检索。
