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

This study uses type 2 diabetes mellitus (T2DM) as an example to develop COS for clinical trials of FSMP.MethodsThe 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.DiscussionWe have prepared an alternative solution of the Likert scale selection, Delphi survey rounds, scoring group, and consensus definitions in case of an unexpected situation.Trial registrationCOMET (1547). Registered on March 23, 2020.
Source: Trials - Category: Research Source Type: clinical trials