Department of Clinical Nutrition, West China Hospital, Sichuan University, #37 Guoxue Alley, Wuhou District, Chengdu, 610041, Sichuan Province, People's Republic of China.
West China School of Public Health, Sichuan University, Chengdu, 610041, People's Republic of China.
Trials. 2023 Mar 24;24(1):223. doi: 10.1186/s13063-023-07214-2.
The Chinese government stipulates all food for special medical purposes (FSMP) designed for specific diseases to be tested in clinical trials before approving it for registration. The process of developing core outcome sets (COSs), the minimum sets of outcomes supposed to be measured and reported, provides an economical and practical option for stakeholders to communicate and cooperate in conducting clinical trials as well as in reporting FSMP outcomes. This study uses type 2 diabetes mellitus (T2DM) as an example to develop COS for clinical trials of FSMP.
The COS for FSMP-T2DM will be divided into 3 phases and developed following COS-STAP and COS-STAD: (1) Generate a list of relevant outcomes identified from a systematic review, in which information sources will mainly include published studies, regulatory documentation, and qualitative interviews of stakeholders. The identified outcomes will be categorized using a conceptual framework and formatted into the first round of the Delphi survey questionnaire items. (2) At least 2 rounds of Delphi surveys will be performed among stakeholders to create the COS for FSMP-T2DM. Patients, clinical dietitians, physicians, COS researchers, journal editors, FSMP manufacturers, and regulatory representatives will be invited to score each outcome from aspects of importance. (3) Hold a face-to-face or online consensus meeting to refine the content of the COS for FSMP-T2DM. Key stakeholders will be invited to attend the meeting to discuss and agree on the final COS.
We have prepared an alternative solution of the Likert scale selection, Delphi survey rounds, scoring group, and consensus definitions in case of an unexpected situation.
COMET (1547). Registered on March 23, 2020.
中国政府规定，所有特定疾病的特殊医学用途配方食品（FSMP）在注册前都需要进行临床试验测试。制定核心结局集（COS）的过程为利益相关者提供了一种经济实用的选择，便于在开展临床试验和报告 FSMP 结果方面进行沟通和合作。本研究以 2 型糖尿病（T2DM）为例，开发 FSMP 临床试验的 COS。
FSMP-T2DM 的 COS 将分为 3 个阶段，并按照 COS-STAP 和 COS-STAD 进行开发：（1）从系统评价中确定相关结局的清单，信息来源主要包括已发表的研究、监管文件和利益相关者的定性访谈。确定的结局将使用概念框架进行分类，并将其格式化为第一轮 Delphi 调查问卷项目。（2）至少进行 2 轮 Delphi 调查，以创建 FSMP-T2DM 的 COS。将邀请患者、临床营养师、医生、COS 研究人员、期刊编辑、FSMP 制造商和监管代表对每个结局的重要性进行评分。（3）召开面对面或在线共识会议，以完善 FSMP-T2DM 的 COS 内容。将邀请主要利益相关者参加会议，讨论并商定最终的 COS。
我们已经准备了替代的李克特量表选择、Delphi 调查轮次、评分组和共识定义，以应对意外情况。
COMET（1547）。于 2020 年 3 月 23 日注册。
