Lindoerfer Doris, Mansmann Ulrich
Institute for Medical Information Processing, Biometry and Epidemiology (IBE), Ludwig-Maximilians-Universität München, Munich, Germany.
J Biomed Inform. 2017 Jul;71:147-153. doi: 10.1016/j.jbi.2017.05.013. Epub 2017 May 20.
Patient registries are instrumental for medical research. Often their structures are complex and their implementations use composite software systems to meet the wide spectrum of challenges. Commercial and open-source systems are available for registry implementation, but many research groups develop their own systems. Methodological approaches in the selection of software as well as the construction of proprietary systems are needed. We propose an evidence-based checklist, summarizing essential items for patient registry software systems (CIPROS), to accelerate the requirements engineering process.
Requirements engineering activities for software systems follow traditional software requirements elicitation methods, general software requirements specification (SRS) templates, and standards. We performed a multistep procedure to develop a specific evidence-based CIPROS checklist: (1) A systematic literature review to build a comprehensive collection of technical concepts, (2) a qualitative content analysis to define a catalogue of relevant criteria, and (3) a checklist to construct a minimal appraisal standard.
CIPROS is based on 64 publications and covers twelve sections with a total of 72 items. CIPROS also defines software requirements. Comparing CIPROS with traditional software requirements elicitation methods, SRS templates and standards show a broad consensus but differences in issues regarding registry-specific aspects.
Using an evidence-based approach to requirements engineering for registry software adds aspects to the traditional methods and accelerates the software engineering process for registry software. The method we used to construct CIPROS serves as a potential template for creating evidence-based checklists in other fields.
The CIPROS list supports developers in assessing requirements for existing systems and formulating requirements for their own systems, while strengthening the reporting of patient registry software system descriptions. It may be a first step to create standards for patient registry software system assessments.
患者登记册对医学研究至关重要。其结构通常很复杂，实施过程中使用复合软件系统来应对广泛的挑战。商业和开源系统均可用于登记册实施，但许多研究团队会开发自己的系统。因此，需要在软件选择以及专有系统构建方面采用方法学途径。我们提出了一份基于证据的清单，总结了患者登记册软件系统的基本要素（CIPROS），以加速需求工程过程。
软件系统的需求工程活动遵循传统的软件需求获取方法、通用软件需求规格说明（SRS）模板和标准。我们执行了一个多步骤程序来制定特定的基于证据的CIPROS清单：（1）进行系统的文献综述以构建技术概念的全面集合；（2）进行定性内容分析以定义相关标准目录；（3）构建一份清单以制定最低评估标准。
CIPROS基于64篇出版物，涵盖十二个部分，共72项。CIPROS还定义了软件需求。将CIPROS与传统软件需求获取方法、SRS模板和标准进行比较，结果显示出广泛共识，但在与登记册特定方面相关的问题上存在差异。
对登记册软件的需求工程采用基于证据的方法，在传统方法的基础上增加了一些方面，并加速了登记册软件的软件工程过程。我们用于构建CIPROS的方法可作为在其他领域创建基于证据的清单的潜在模板。
CIPROS清单有助于开发人员评估现有系统的需求并制定自己系统的需求，同时加强患者登记册软件系统描述的报告。这可能是创建患者登记册软件系统评估标准的第一步。
