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Validating a transnational fracture treatment registry using a standardized method.
BMC Medical Research Methodology ( IF 4 ) Pub Date : 2019-12-18 , DOI: 10.1186/s12874-019-0862-1
Jasper Frese 1 , Annalice Gode 1 , Gerhard Heinrichs 1 , Armin Will 2 , Arndt-Peter Schulz 3
Affiliation  

AIM Subsequent to a three-month pilot phase, recruiting patients for the newly established BFCC (Baltic Fracture Competence Centre) transnational fracture registry, a validation of the data quality needed to be carried out, applying a standardized method. METHOD During the literature research, the method of "adaptive monitoring" fulfilled the requirements of the registry and was applied. It consisted of a three-step audit process; firstly, scoring of the overall data quality, followed by source data verification of a sample size, relative to the scoring result, and finally, feedback to the registry on measures to improve data quality. Statistical methods for scoring of data quality and visualisation of discrepancies between registry data and source data were developed and applied. RESULTS Initially, the data quality of the registry scored as medium. During source data verification, missing items in the registry, causing medium data quality, turned out to be absent in the source as well. A subsequent adaptation of the score evaluated the registry's data quality as good. It was suggested to add variables to some items in order to improve the accuracy of the registry. DISCUSSION The application of the method of adaptive monitoring has only been published by Jacke et al., with a similar improvement of the scoring result following the audit process. Displaying data from the registry in graphs helped to find missing items and discover issues with data formats. Graphically comparing the degree of agreement between the registry and source data allowed to discover systematic faults. CONCLUSIONS The method of adaptive monitoring gives a substantiated guideline for systematically evaluating and monitoring a registry's data quality and is currently second to none. The resulting transparency of the registry's data quality could be helpful in annual reports, as published by most major registries. As the method has been rarely applied, further successive applications in established registries would be desirable.

中文翻译:

使用标准化方法验证跨国骨折治疗注册中心。

目的在为期三个月的试验阶段之后,招募患者参加新建立的BFCC(波罗的海骨折能力中心)跨国骨折登记处,需要采用标准化方法对数据质量进行验证。方法在文献研究中,“自适应监控”方法满足了注册表的要求并得到了应用。它由三步审核过程组成;首先,对总体数据质量进行评分,然后对相对于评分结果的样本量进行源数据验证,最后,向注册管理机构反馈有关改善数据质量的措施。开发并应用了统计数据质量的评分方法和可视化注册表数据与源数据之间的差异的统计方法。结果最初,注册表的数据质量为中级。在源数据验证过程中,源中也缺少注册表中缺少的项,从而导致中等的数据质量。分数的后续调整认为注册表的数据质量良好。建议为某些项目添加变量,以提高注册表的准确性。讨论自适应监视方法的应用仅由Jacke等人公开,在审核过程之后,评分结果也有类似的改进。以图形形式显示注册表中的数据有助于查找缺失的项目并发现数据格式问题。以图形方式比较注册表和源数据之间的一致性程度,以发现系统性故障。结论自适应监视方法为系统评估和监视注册表的数据质量提供了有效的指导,目前尚无人可及。正如大多数主要注册管理机构所发布的那样,由此得出的注册管理机构数据质量的透明性可能有助于年度报告。由于该方法很少应用,因此希望在已建立的注册表中进行进一步的连续应用。
更新日期:2019-12-19
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