Quality Control for Spine Registries: Development and Application of a New Protocol.

Abstract

Registries are gaining importance both in clinical practice and for research purposes. However, quality control is paramount to ensure that data are consistent and reliable. Quality control protocols have been proposed for arthroplasty registries, but these are not directly applicable to the spine setting. This study aims to develop a new quality control protocol for spine registries. Based on the available protocols for arthroplasty registries, a new protocol for spine registries was developed. The items included in the protocol were completeness (yearly enrollment rate and rate of assessment completion), consistency, and internal validity (coherence between registry data and medical records for blood loss, body mass index, and treated levels). All aspects were then applied to the spine registry of the Institution to verify its quality for each of the 5 years in which the registry has been used (2016-2020). Regarding completeness, the yearly enrollment rate ranged from 78 to 86%; the completion of preoperative assessment from 79% to 100%. The yearly consistency rate varied from 83% to 86%. Considering internal validity, the interclass correlation coefficient ranged from 0.1 to 0.8 for blood loss and from 0.3 to 0.9 for body mass index. The coherency for treated levels ranged from 25% to 82%. Overall, all 3 items showed an improvement over time. All 3 analyzed domains showed good to excellent results. The overall quality of the registered data improved over time.