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. These slides can be retrieved under Electronic Supplementary Material.
Keywords: Evidence-based medicine; Quality management; Registry; Scientific value; Spine.