Deane Katherine, Delbecque Laure, Gorbenko Oleksandr, Hamoir Anne Marie, Hoos Anton, Nafria Begonya, Pakarinen Chi, Sargeant Ify, Richards Dawn P, Skovlund Soren Eik, Brooke Nicholas
School of Health Sciences, University of East Anglia, Norwich, UK.
Patient Reported Outcomes, Pharmerit International, Rotterdam, Belgium.
BMJ Innov. 2019 Jan;5(1):43-55. doi: 10.1136/bmjinnov-2018-000317. Epub 2019 Mar 2.
Meaningful patient engagement (PE) can enhance medicines' development. However, the current PE landscape is fragmentary and lacking comprehensive guidance.
We systematically searched for PE initiatives (SYNaPsE database/publications). Multistakeholder groups integrated these with their own PE expertise to co-create draft PE Quality Guidance which was evaluated by public consultation. Projects exemplifying good PE practice were identified and assessed against PE Quality Criteria to create a Book of Good Practices (BOGP).
Seventy-six participants from 51 organisations participated in nine multistakeholder meetings (2016-2018). A shortlist of 20relevant PE initiatives (from 170 screened) were identified. The co-created INVOLVE guidelines provided the main framework for PE Quality Guidance and was enriched with the analysis of the PE initiatives and the PE expertise of stakeholders. Seven key PE Quality Criteria were identified. Public consultation yielded 67 responses from diverse backgrounds. The PE Quality Guidance was agreed to be useful for achieving quality PE in practice, understandable, easy to use, and comprehensive. Overall, eight initiatives from the shortlist and from meeting participants were selected for inclusion in the BOGP based on demonstration of PE Quality Criteria and willingness of initiative owners to collaborate.
The PE Quality Guidance and BOGP are practical resources which will be continually updated in response to user feedback. They are not prescriptive, but rather based on core principles, which can be applied according to the unique needs of each interaction and initiative. Implementation of the guidance will facilitate improved and systematic PE across the medicines' development lifecycle.
有意义的患者参与（PE）可以促进药物研发。然而，当前的患者参与情况零散，缺乏全面的指导。
我们系统地搜索了患者参与计划（SYNaPsE数据库/出版物）。多利益相关方团体将这些计划与自身的患者参与专业知识相结合，共同制定患者参与质量指导草案，并通过公众咨询进行评估。确定了体现良好患者参与实践的项目，并根据患者参与质量标准进行评估，以创建一本良好实践手册（BOGP）。
来自51个组织的76名参与者参加了9次多利益相关方会议（2016 - 2018年）。从170个筛选的计划中确定了20个相关患者参与计划的入围名单。共同创建的INVOLVE指南为患者参与质量指导提供了主要框架，并通过对患者参与计划和利益相关方的患者参与专业知识的分析得到了丰富。确定了七个关键的患者参与质量标准。公众咨询收到了来自不同背景的67份回复。大家一致认为患者参与质量指导对于在实践中实现高质量的患者参与是有用的、易于理解的、便于使用的且全面的。总体而言，根据患者参与质量标准的展示以及计划所有者的合作意愿，从入围名单和会议参与者中挑选了八个计划纳入良好实践手册。
患者参与质量指导和良好实践手册是实用资源，将根据用户反馈不断更新。它们不是规定性的，而是基于核心原则，可以根据每次互动和计划的独特需求进行应用。该指导的实施将有助于在药物开发生命周期中改善和系统地开展患者参与。
