Unsworth Harriet, Dillon Bernice, Collinson Lucie, Powell Helen, Salmon Mark, Oladapo Tosin, Ayiku Lynda, Shield Gary, Holden Joanne, Patel Neelam, Campbell Mark, Greaves Felix, Joshi Indra, Powell John, Tonnel Alexia
Department of Computer Science, University of Liverpool, UK.
Centre for Health Technology Evaluation, NICE, Manchester, UK.
Digit Health. 2021 Jun 24;7:20552076211018617. doi: 10.1177/20552076211018617. eCollection 2021 Jan-Dec.
In 2018, the UK National Institute for Health and Care Excellence (NICE), in partnership with Public Health England, NHS England, NHS Improvement and others, developed an evidence standards framework (ESF) for digital health and care technologies (DHTs). The ESF was designed to provide a standardised approach to guide developers and commissioners on the levels of evidence needed for the clinical and economic evaluation of DHTs by health and care systems.
The framework was developed using an agile and iterative methodology that included a literature review of existing initiatives and comparison of these against the requirements set by NHS England; iterative consultation with stakeholders through an expert working group and workshops; and questionnaire-based stakeholder input on a publicly available draft document.
The evidence standards framework has been well-received and to date the ESF has been viewed online over 55,000 times and downloaded over 19,000 times.
In April 2021 we published an update to the ESF. Here, we summarise the process through which the ESF was developed, reflect on its global impact to date, and describe NICE's ongoing work to maintain and improve the framework in the context for a fast moving, innovative field.
2018年，英国国家卫生与临床优化研究所（NICE）与英国公共卫生署、英国国民保健服务体系（NHS）英格兰分部、NHS改进部门及其他机构合作，制定了数字健康与护理技术（DHT）的证据标准框架（ESF）。该框架旨在提供一种标准化方法，指导开发者和委托方了解健康与护理系统对DHT进行临床和经济评估所需的证据水平。
该框架采用敏捷迭代方法制定，包括对现有举措进行文献综述，并将其与NHS英格兰分部设定的要求进行比较；通过专家工作组和研讨会与利益相关者进行迭代磋商；以及基于问卷收集利益相关者对一份公开草稿文件的意见。
证据标准框架受到了广泛欢迎，截至目前，ESF的在线浏览量已超过55000次，下载量超过19000次。
2021年4月，我们发布了ESF的更新版本。在此，我们总结了ESF的制定过程，反思了其迄今为止的全球影响，并描述了NICE在这个快速发展的创新领域中为维护和改进该框架而正在进行的工作。
