CHISEL: Item categories from Stage 1 Survey, and Stage 2 Verification

The project follows an adapted version of the James Lind Alliance (JLA) Priority Setting Partnership (PSP) approach. It is led by a multidisciplinary project team of paediatric experts and methodologists, in close collaboration with key stakeholders. The main project stages are: 1) Gathering uncertainties via a survey of paediatric experts and methodologists, and qualitative consultation with families, supplemented with an existing list already harvested from the literature. This results in a long-list of challenge and barriers to paediatric trials. 2) Verifying uncertainties by removing out-of-scope items, grouping in-scope items into themes, and creating summary questions that are then checked against existing methods to confirm genuine gaps. 3) Interim priority setting where all stakeholders are invited to review the list and select up to 10 priorities through a national, online survey. 4) Final priority setting to identify the ultimate Top10 priorities. This is through a consensus workshop with shared decision-making between paediatric experts, methodologists and families, using an adapted Delphi meeting approach.The present document lists the long-list of resulting clusters from the Stage 1 survey, and Stage 2 verification. This is in parallel with the interim priority setting, and separately from the ultimate, resulting overall publication.

本项目采用改编版的詹姆斯·林德联盟（James Lind Alliance, JLA）优先级设定伙伴关系（Priority Setting Partnership, PSP）方法，由儿科专家与方法学家组成的多学科项目团队牵头，并与关键利益相关方开展紧密协作。项目主要阶段如下：1) 通过面向儿科专家与方法学家的调研、面向患儿家属的定性咨询，辅以已从文献中提取的既有清单，收集各类不确定性问题，最终形成儿科临床试验面临的挑战与障碍长清单。2) 验证不确定性：剔除超出研究范围的条目，将符合范围的条目归类为主题，并提炼总结性问题，随后对照现有研究方法进行校验，以确认其确为真实存在的研究空白。3) 中期优先级设定：邀请所有利益相关方审阅清单，并通过全国性在线调研从其中选取至多10项优先级研究方向。4) 最终优先级设定：通过采用改编版德尔菲（Delphi）会议法开展共识研讨会，由儿科专家、方法学家与患儿家属共同参与并进行协同决策，以确定最终的Top10优先级项目。本文件列出了第一阶段调研与第二阶段验证所得到的聚类长清单，该内容与中期优先级设定工作并行开展，且独立于最终形成的整体研究成果出版物。