Baig Mansoor Ali, Alzahrani Somayah J, Almuhaizea Mohamad A, Al-Shagathrh Fahad
King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia.
Department of Biostatistics Epidemiology & Scientific Computing, KFSHRC, KSA.
Stud Health Technol Inform. 2019 Jul 4;262:384-387. doi: 10.3233/SHTI190099.
A National registry program is a resource intensive initiative involving multiple stakeholders, multi-institutional/multi-role/multi-users collaborative effort, where various aspects starting from work culture, research culture, registry conceptualization, resource availability, data format, data storage/retrieval techniques, data sharing protocols, data/dataset standards, data quality etc. vary drastically between different institutions. The biggest challenge for a national program will be to map these aspects under a common umbrella to establish standards for operations/execution, policies and procedures, which means aligning the registry operations with the operative process of each institution at first, due to this only a handful initiatives are implemented with limited success, hence it is advisable to study such implementations in great details as a guideline to build a solid foundation for future national initiatives[1][2]. The idea goes around building a solid database for holding all clinical registries under a single repository, along with streamlining and generalizing the policies and procedures for any disease or medical device registry, in order to save infrastructure spending, streamlining, saving on management and operational costs and overheads.
国家注册项目是一项资源密集型举措,涉及多个利益相关者,需要多机构/多角色/多用户的协作努力,不同机构在工作文化、研究文化、注册概念化、资源可用性、数据格式、数据存储/检索技术、数据共享协议、数据/数据集标准、数据质量等各个方面差异巨大。国家项目面临的最大挑战是将这些方面统一起来,建立操作/执行标准、政策和程序,这意味着首先要使注册操作与每个机构的操作流程保持一致,正因如此,只有少数项目得以实施,且成效有限,因此,详细研究此类实施情况作为指南,为未来的国家项目奠定坚实基础是明智之举[1][2]。其理念是构建一个坚实的数据库,将所有临床注册信息集中存储在一个存储库中,同时简化和统一任何疾病或医疗设备注册的政策和程序,以节省基础设施支出、实现流程简化、节省管理和运营成本及开销。