基于 CMDX 的单一来源信息系统，用于简化前列腺癌的质量管理和临床研究。
CMDX©-based single source information system for simplified quality management and clinical research in prostate cancer.
机构信息
Department of Urology, University Hospital of Cologne, Kerpener Strasse, 62, Cologne D-50937, Germany.
出版信息
BMC Med Inform Decis Mak. 2012 Dec 3;12:141. doi: 10.1186/1472-6947-12-141.
BACKGROUND
Histopathological evaluation of prostatectomy specimens is crucial to decision-making and prediction of patient outcomes in prostate cancer (PCa). Topographical information regarding PCa extension and positive surgical margins (PSM) is essential for clinical routines, quality assessment, and research. However, local hospital information systems (HIS) often do not support the documentation of such information. Therefore, we investigated the feasibility of integrating a cMDX-based pathology report including topographical information into the clinical routine with the aims of obtaining data, performing analysis and generating heat maps in a timely manner, while avoiding data redundancy.
METHODS
We analyzed the workflow of the histopathological evaluation documentation process. We then developed a concept for a pathology report based on a cMDX data model facilitating the topographical documentation of PCa and PSM; the cMDX SSIS is implemented within the HIS of University Hospital Muenster. We then generated a heat map of PCa extension and PSM using the data. Data quality was assessed by measuring the data completeness of reports for all cases, as well as the source-to-database error. We also conducted a prospective study to compare our proposed method with recent retrospective and paper-based studies according to the time required for data analysis.
RESULTS
We identified 30 input fields that were applied to the cMDX-based data model and the electronic report was integrated into the clinical workflow. Between 2010 and 2011, a total of 259 reports were generated with 100% data completeness and a source-to-database error of 10.3 per 10,000 fields. These reports were directly reused for data analysis, and a heat map based on the data was generated. PCa was mostly localized in the peripheral zone of the prostate. The mean relative tumor volume was 16.6%. The most PSM were localized in the apical region of the prostate. In the retrospective study, 1623 paper-based reports were transferred to cMDX reports; this process took 15 ± 2 minutes per report. In a paper-based study, the analysis data preparation required 45 ± 5 minutes per report.
CONCLUSIONS
cMDX SSIS can be integrated into the local HIS and provides clinical routine data and timely heat maps for quality assessment and research purposes.
背景
前列腺癌（PCa）患者的前列腺切除术标本的组织病理学评估对于决策和预测患者预后至关重要。PCa 扩展和阳性手术切缘（PSM）的拓扑信息对于临床常规、质量评估和研究至关重要。然而，当地医院信息系统（HIS）通常不支持此类信息的记录。因此，我们研究了将基于 cMDX 的病理报告纳入临床常规，包括拓扑信息的可行性，目的是及时获取数据、进行分析和生成热图，同时避免数据冗余。
方法
我们分析了组织病理学评估文档流程的工作流程。然后，我们基于促进 PCa 和 PSM 的拓扑文档的 cMDX 数据模型开发了病理报告的概念；cMDX SSIS 在明斯特大学医院的 HIS 中实现。然后，我们使用该数据生成了 PCa 扩展和 PSM 的热图。通过测量所有病例报告的数据完整性以及源到数据库的错误，评估数据质量。我们还进行了一项前瞻性研究，根据数据分析所需的时间，将我们提出的方法与最近的回顾性和基于纸张的研究进行了比较。
结果
我们确定了 30 个输入字段，应用于基于 cMDX 的数据模型，电子报告集成到临床工作流程中。2010 年至 2011 年期间，共生成了 259 份报告，数据完整性达到 100%，源到数据库的错误率为每 10000 个字段 10.3。这些报告直接用于数据分析，并生成了基于该数据的热图。PCa 主要位于前列腺的外周区。平均相对肿瘤体积为 16.6%。最多的 PSM 位于前列腺的顶端区域。在回顾性研究中，1623 份纸质报告被转换为 cMDX 报告；每份报告的转换过程耗时 15±2 分钟。在基于纸张的研究中，每份报告的数据准备分析需要 45±5 分钟。
结论
cMDX SSIS 可以集成到本地 HIS 中，并为质量评估和研究目的提供临床常规数据和及时的热图。
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