Background
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.
Methods
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.
Discussion
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.
This study uses type 2 diabetes mellitus (T2DM) as an example to develop COS for clinical trials of FSMP.
ContributorsDongyu Mu
Sichuan University West China Hospital
Jie Gong
Sichuan University West China Hospital
Yaoyao Wei
Sichuan University West China School of Public Health
Muxi Chen
Sichuan University West China School of Medicine
Jiajie Yu
Chinese Cochrane Center
Liang Du
Sichuan University West China Hospital
Wen Hu
Sichuan University West China Hospital
Disease Category: Endocrine & metabolic, Other
Disease Name: Diabetes mellitus
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Diet and nutrition
- COS for clinical trials or clinical research