IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.
Department of Orthopaedics and Trauma Surgery, RWTH Uniklinik Aachen, Germany.
Am J Med Qual. 2023;38(4):181-187. doi: 10.1097/JMQ.0000000000000128. Epub 2023 Jun 15.
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.
登记处无论在临床实践还是研究目的方面都变得越来越重要。然而，为了确保数据的一致性和可靠性，质量控制至关重要。已经为关节置换登记处提出了质量控制协议，但这些协议不适用于脊柱环境。本研究旨在为脊柱登记处开发新的质量控制协议。在现有的关节置换登记处协议的基础上，为脊柱登记处开发了一个新的协议。该协议中包含的项目包括完整性（每年的入组率和评估完成率）、一致性和内部有效性（登记处数据与病历中失血量、体重指数和治疗水平之间的一致性）。然后，将所有方面应用于该机构的脊柱登记处，以验证其在使用该登记处的 5 年中的每一年的质量（2016-2020 年）。关于完整性，每年的入组率从 78%到 86%不等；术前评估的完成率从 79%到 100%不等。每年的一致性率从 83%到 86%不等。考虑到内部有效性，失血量的组内相关系数从 0.1 到 0.8 不等，体重指数从 0.3 到 0.9 不等。治疗水平的一致性从 25%到 82%不等。总体而言，所有 3 项指标均随时间推移而改善。所有 3 个分析领域均取得了良好到优秀的结果。注册数据的整体质量随时间推移而提高。
