Centre for Health Informatics, Division of Informatics, Imaging and Data Science, University of Manchester, Manchester, United Kingdom.
Pankhurst Institute for Health Technology Research and Innovation, University of Manchester, Manchester, United Kingdom.
J Med Internet Res. 2024 Jul 23;26:e49230. doi: 10.2196/49230.
Pharmacogenetics can impact patient care and outcomes through personalizing the selection of medicines, resulting in improved efficacy and a reduction in harmful side effects. Despite the existence of compelling clinical evidence and international guidelines highlighting the benefits of pharmacogenetics in clinical practice, implementation within the National Health Service in the United Kingdom is limited. An important barrier to overcome is the development of IT solutions that support the integration of pharmacogenetic data into health care systems. This necessitates a better understanding of the role of electronic health records (EHRs) and the design of clinical decision support systems that are acceptable to clinicians, particularly those in primary care.
Explore the needs and requirements of a pharmacogenetic service from the perspective of primary care clinicians with a view to co-design a prototype solution.
We used ethnographic and think-aloud observations, user research workshops, and prototyping. The participants for this study included general practitioners and pharmacists. In total, we undertook 5 sessions of ethnographic observation to understand current practices and workflows. This was followed by 3 user research workshops, each with its own topic guide starting with personas and early ideation, through to exploring the potential of clinical decision support systems and prototype design. We subsequently analyzed workshop data using affinity diagramming and refined the key requirements for the solution collaboratively as a multidisciplinary project team.
User research results identified that pharmacogenetic data must be incorporated within existing EHRs rather than through a stand-alone portal. The information presented through clinical decision support systems must be clear, accessible, and user-friendly as the service will be used by a range of end users. Critically, the information should be displayed within the prescribing workflow, rather than discrete results stored statically in the EHR. Finally, the prescribing recommendations should be authoritative to provide confidence in the validity of the results. Based on these findings we co-designed an interactive prototype, demonstrating pharmacogenetic clinical decision support integrated within the prescribing workflow of an EHR.
This study marks a significant step forward in the design of systems that support pharmacogenetic-guided prescribing in primary care settings. Clinical decision support systems have the potential to enhance the personalization of medicines, provided they are effectively implemented within EHRs and present pharmacogenetic data in a user-friendly, actionable, and standardized format. Achieving this requires the development of a decoupled, standards-based architecture that allows for the separation of data from application, facilitating integration across various EHRs through the use of application programming interfaces (APIs). More globally, this study demonstrates the role of health informatics and user-centered design in realizing the potential of personalized medicine at scale and ensuring that the benefits of genomic innovation reach patients and populations effectively.
通过个性化选择药物，药物遗传学可以影响患者的护理和治疗效果，从而提高疗效，减少有害的副作用。尽管有令人信服的临床证据和国际指南强调了药物遗传学在临床实践中的益处，但在英国国民保健服务系统中实施的范围有限。克服的一个重要障碍是开发支持将药物遗传学数据集成到医疗保健系统中的 IT 解决方案。这需要更好地了解电子健康记录（EHR）的作用以及设计可被临床医生（尤其是初级保健医生）接受的临床决策支持系统。
从初级保健临床医生的角度探讨药物遗传学服务的需求和要求，以期共同设计原型解决方案。
我们使用民族志和出声思考观察、用户研究研讨会和原型设计。本研究的参与者包括全科医生和药剂师。我们共进行了 5 次民族志观察，以了解当前的实践和工作流程。随后进行了 3 次用户研究研讨会，每次都有自己的主题指南，从角色和早期构思开始，到探索临床决策支持系统的潜力和原型设计。我们随后使用亲和图分析对研讨会数据进行分析，并作为一个多学科项目团队共同完善解决方案的关键要求。
用户研究结果表明，药物遗传学数据必须纳入现有的 EHR 中，而不是通过单独的门户。通过临床决策支持系统提供的信息必须清晰、易于访问且用户友好，因为该服务将由各种最终用户使用。至关重要的是，信息应该显示在处方工作流程中，而不是作为静态存储在 EHR 中的离散结果。最后，处方建议应该具有权威性，以提供对结果有效性的信心。基于这些发现，我们共同设计了一个交互式原型，展示了在 EHR 处方工作流程中集成的药物遗传学临床决策支持。
这项研究标志着在设计支持初级保健环境中药物遗传学指导处方的系统方面迈出了重要的一步。临床决策支持系统有可能增强药物的个性化，前提是它们在 EHR 中得到有效实施，并以用户友好、可操作和标准化的格式呈现药物遗传学数据。要实现这一点，需要开发一种解耦的、基于标准的架构，允许将数据与应用程序分离，通过使用应用程序编程接口（API）促进各种 EHR 之间的集成。更广泛地说，这项研究展示了健康信息学和以用户为中心的设计在实现个性化医学的潜力并确保基因组创新的益处有效地惠及患者和人群方面的作用。
