Department of Obstetrics and Gynaecology, Monash University, 252 Clayton Road, Clayton, Victoria, 3168, Australia.
Biorithm Pte Ltd, 81 Ayer Rajah Crescent 03-53, Singapore, 139967, Singapore.
BMC Health Serv Res. 2019 Jul 23;19(1):514. doi: 10.1186/s12913-019-4305-9.
Early Health Technology Assessment (EHTA) is an evolving field in health policy which aims to provide decision support and mitigate risk during early medical device innovation. The clinician is a key stakeholder in this process and their role has traditionally been confined to assessing device efficacy and safety alone. There is however, no data exploring their role in this process and how they can contribute towards it. This motivated us to carry out a systematic review to delineate the role of the clinician in EHTA as per the PRISMA guidelines.
A systematic search of peer reviewed literature was undertaken across PUBMED, OVID Medline and Web of science up till June 2018. Studies that were suitable for inclusion focused on clinician input in health technology assessment or early medical device innovation. A qualitative approach was utilised to generate themes on how clinicians could contribute in general and specific areas of EHTA. Data was manually extracted by the authors and themes were agreed in consensus using a grounded theory framework. The specific stages included: All stages of EHTA, Basic research on mechanisms, Targeting for specific product, Proof of principle and Prototype and product development. Bias was assessed utilising the NICE Qualitative checklist.
A total of 33 articles met the inclusion criteria for the review. Areas identified in which the clinicians could contribute to EHTA included: i) needs driven problem solving, ii) conformity assessment of MDs, iii) economic evaluation of MDs and iv) addressing the conflicts in interest. For clinicians' input across the various specific areas of EHTA, an innovation framework was generated based on the subthemes extracted.
The following review has identified the various segments in which clinicians can contribute to EHTA to inform stakeholders and has also proposed an innovation framework.
早期卫生技术评估（EHTA）是卫生政策中一个不断发展的领域，旨在为早期医疗器械创新提供决策支持并降低风险。临床医生是这一过程中的关键利益相关者，他们的角色传统上仅限于评估器械的疗效和安全性。但是，目前没有数据探讨他们在这一过程中的作用以及他们如何为这一过程做出贡献。这促使我们进行了一项系统评价，以根据 PRISMA 指南描绘临床医生在 EHTA 中的作用。
我们对 PUBMED、OVID Medline 和 Web of Science 进行了系统的文献检索，检索时间截至 2018 年 6 月。适合纳入的研究集中于临床医生在卫生技术评估或早期医疗器械创新中的投入。我们采用定性方法生成主题，探讨临床医生如何在一般和 EHTA 的具体领域做出贡献。作者手动提取数据，并使用扎根理论框架达成共识确定主题。具体阶段包括：EHTA 的所有阶段、机制的基础研究、针对特定产品的目标、原理验证和原型及产品开发。我们利用 NICE 定性清单评估偏倚。
共有 33 篇文章符合综述的纳入标准。确定了临床医生可以为 EHTA 做出贡献的领域包括：i）需求驱动的解决问题，ii）MD 的一致性评估，iii）MD 的经济评估，以及 iv）解决利益冲突。对于临床医生在 EHTA 各个具体领域的投入，我们根据提取的子主题生成了一个创新框架。
本综述确定了临床医生可以为 EHTA 做出贡献的各个环节，为利益相关者提供了信息，并提出了一个创新框架。
