厚积薄发——中国甲状腺肿瘤临床数据库分级质量管理的建议与思考
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程若川, Email: cruochuan@foxmail.com


Breakthrough through accumulation: suggestions and reflections on hierarchical quality management of thyroid cancer clinical database in China
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    摘要:

    数据库建设在甲状腺肿瘤临床研究中取得丰硕的科研成果,以大数据库为基础的临床研究引导各指南的制定和更新,推动甲状腺外科临床实践的进步。我国甲状腺肿瘤数据库建设起步较晚,中国人群的甲状腺癌的高质量循证医学证据仍有所欠缺,临床指南参考证据也仍有不足。近年来,依托互联网技术的发展和庞大的患者群体,我国甲状腺肿瘤临床数据库建设发展迅速。然而,由于缺乏数据库建设的质量控制标准,在各种临床信息数据化的过程中,随着数据可利用性的提高,真实性、完整性降低的风险大大增加。笔者结合所在中心甲状腺肿瘤数据库建设中的经验和问题,提出甲状腺肿瘤临床数据库分级质量管理的一些初步构想和建议。数据库的建设和应用过程即为从原始信息提取为最终科研论文数据的过程,我们将各级数据库信息特征总结为从0~3级数据的逐步采录过程。下一级数据的质量控制依赖于上一级数据的真实性和可利用性。随着病例信息数据的逐级转录,数据可利用性逐步上升至可临床科研应用水平,而真实性逐渐下降。数据库质量控制即为在提高可利用性的过程尽可能保证数据的真实性。其中,1级数据是数据库建设过程中数据损失风险较高,提高该级数据质量是提升数据库整体质量的基础和关键所在。本文分别从临床病历信息中的检验、病理报告(1A级),超声报告(1B级)和文字记录(1C级)等不同层面分享了数据库质量管理的一些思考,并提出结构化的1级病历数据建议,以期改善数据库的整体质量。近年来,基于大数据的人工智能诊断、疾病预测模型等方向的研究开展如火如荼,然而,如缺乏良好的原始数据库基础,后期几乎无法改善,在大数据库的建设中可能导致“事倍功半”的尴尬局面。此类数据库的管理问题可能在各专科领域、各个国家数据库建设中普遍存在。因此,本文旨在呼吁国内同道共同关注于数据库的质量控制,从而依托不同中心数据库建设经验,群策群力,共同制定更为合理的我国甲状腺肿瘤临床数据库分级管理办法。

    Abstract:

    Clinical database construction has made great achievements in clinical research of thyroid tumors. Large database-based clinical studies lead the development and updating of guidelines, and promote the development of clinical practice in thyroid surgery. The thyroid cancer database construction starts relatively late in China. There is still a lack of high-quality evidence-based medicine data on Chinese population for thyroid cancer, as well as reference evidence for clinical guidelines. In recent years, the construction of thyroid tumor clinical database has increasingly developed depending on the evolution of internet technology and a large number of patients in China. However, due to the lack of quality control standards for database construction, and with the improvement of data availability, the risk of authenticity and integrity reduction is greatly increased during the process of various clinical information digitalizing. Based on experience and problems encountered during construction of thyroid tumor clinical database in the authors’ center, the authors present some preliminary ideas and suggestion on graded quality management of thyroid tumor clinical database. The process of database construction and application can be summarized as extracting the original information to convert the data for the final scientific research paper. The information characteristics of database were summarized as a step by step process of data acquisition on a scale of 0 to 3. The quality control of the data depends on the authenticity and availability of the data at the superior adjacent level. With the progressively transcriptions of information data, the data availability gradually increased to the level for scientific research application, while the authenticity gradually decreased. Database quality control is to ensure the authenticity of data as much as possible in the process of improving availability. Improving level-1 data quality is the foundation and key to improve the overall quality of the database, because that is at a higher risk of data loss during database construction. In order to improve the overall quality of the database, this paper shares some thoughts on data quality management from different aspects of medical record, including laboratory examination (level-1A), pathological report (level-1A), ultrasonic report (level-1B), and written record. In addition, we also propose structured level-1 medical record data recommendations. Over the years, clinical research of artificial intelligence diagnosis and disease prediction models based on big data has been carried out in full swing. However, the lack of satisfactory original database is difficult to improve later; the construction of a large database may lead to the embarrassing situation of “getting half the result with twice the effort”. This management problem may be ubiquitous in every specialized field and every national database construction. Therefore, the purpose of this paper is to call for the domestic colleagues pay attention to the quality control of the database and integrate the experiences of database construction from different centers, so as to brainstorm ideas and jointly develop a more reasonable hierarchical management of thyroid tumor clinical database in China.

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程若川, 刘文.厚积薄发——中国甲状腺肿瘤临床数据库分级质量管理的建议与思考[J].中国普通外科杂志,2020,29(11):1282-1292.
DOI:10.7659/j. issn.1005-6947.2020.11.001

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  • 收稿日期:2020-09-28
  • 最后修改日期:2020-10-25
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  • 在线发布日期: 2020-11-25