BACKGROUND New opportunities to record, collate, and analyze routine patient data have prompted optimism about the potential of learning health systems. However, real-life examples of such systems remain rare and few have been exposed to study. We aimed to examine the views of design stakeholders on designing and implementing a US-based registry-enabled care and learning system for cystic fibrosis (RCLS-CF). METHODS We conducted a two-phase qualitative study with stakeholders involved in designing, implementing, and using the RCLS-CF. First, we conducted semi-structured interviews with 19 program personnels involved in design and delivery of the program. We then undertook 11 follow-up interviews. Analysis of interviews was based on the constant comparative method, supported by NVivo software. RESULTS The organizing principle for the RCLS-CF was a shift to more partnership-based relationships between patients and clinicians, founded in values of co-production, and facilitated by technology-enabled data sharing. Participants proposed that, for the system to be successful, the data it collects must be both clinically useful and meaningful to patients and clinicians. They suggested that the prerequisites included a technological infrastructure capable of supporting data entry and joint decision-making in an accessible way, and a set of social conditions, including willingness from patients and clinicians alike to work together in new ways that build on the expertise of both parties. Follow-up interviews highlighted some of the obstacles, including technical challenges and practical constraints on refiguring relationships between clinicians and patients. CONCLUSIONS The values and vision underlying the RCLS-CF were shared and clearly and consistently articulated by design stakeholders. The challenges to realization were often not at the level of principle, but were both practical and social in character. Lessons from this study may be useful to other systems looking to harness the power of "big data" registries, including patient-reported data, for care, research, and quality improvement.

中文翻译：

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对设计利益相关者对开发和实施基于注册表的学习健康系统的看法进行定性研究。


背景技术记录、整理和分析常规患者数据的新机会促使人们对学习型医疗系统的潜力持乐观态度。然而，此类系统的现实例子仍然很少，而且很少有人进行研究。我们的目的是研究设计利益相关者对设计和实施基于美国注册的囊性纤维化护理和学习系统（RCLS-CF）的看法。方法 我们与参与设计、实施和使用 RCLS-CF 的利益相关者进行了一项两阶段的定性研究。首先，我们对参与项目设计和交付的 19 名项目人员进行了半结构化访谈。然后我们进行了 11 次后续访谈。访谈分析基于持续比较法，并由 NVivo 软件支持。结果 RCLS-CF 的组织原则是转向患者和临床医生之间更多基于伙伴关系的关系，建立在共同生产的价值观上，并通过技术支持的数据共享来促进。参与者提出，为了使系统取得成功，它收集的数据必须对患者和临床医生既有临床用途又有意义。他们认为，先决条件包括能够以可访问的方式支持数据输入和联合决策的技术基础设施，以及一系列社会条件，包括患者和临床医生愿意以基于患者专业知识的新方式合作。双方。后续采访强调了一些障碍，包括技术挑战和重新调整临床医生与患者之间关系的实际限制。 结论 RCLS-CF 背后的价值观和愿景得到了设计利益相关者的认同，并清晰一致地表达出来。实现的挑战往往不是原则层面的，而是实际的和社会性的。这项研究的经验教训可能对其他希望利用“大数据”登记的力量（包括患者报告的数据）进行护理、研究和质量改进的系统有用。