[Several Aspects Worthy of Attention in the Pre-research of Medical Device Standards].

The pre-research of medical device standards is of great significance for the enactment and amendment of standards. This study discusses four aspects and explores how to promote more scientific and reasonable pre-research. Based on the pre-research practice of medical device standards project, this study puts forward relevant work ideas and suggestions.

Engaging patients and stakeholders in preresearch: findings from the Pipeline to Proposal Awards Initiative.

Aim: The Patient-Centered Outcomes Research Institute Pipeline to Proposal (P2P) Awards Initiative funded 177 awardees to engage patients and stakeholder partners in preresearch. Based on P2P, we described engagement strategies; outcomes; facilitators; and challenges to inform research funders and stakeholders participating in preresearch. Materials & methods: We used a qualitative approach based on content analysis of program data and interviews with P2P awardees and partners. Results: Awardees developed partnership infrastructure by recruiting patients and stakeholders, establishing clear roles, and providing training. Building trust was key to engaging patients and stakeholders in preresearch. Awardees reported partners were more likely to engage in PCOR in the future. Conclusion: P2P awardees increased capacity of patient and stakeholder partnerships to conduct PCOR.