Development of core outcome sets of Food for Special Medical Purposes designed for type 2 diabetes mellitus: a study protocol.

ABSTRACT:

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 sour

SUBMITTER: Mu D 

PROVIDER: S-EPMC10037765 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature