Core outcome sets (COS) are agreed standard sets of outcomes that should be measured and reported, as a minimum, in all clinical trials in specific areas of health or healthcare. Chinese government stipulates that all Food for Special Medical Purposes (FSMP) designed for specific diseases should be tested on clinical trials before released to the market. Processes of developing COS provide an economical and practical option for diverse stakeholders to communicate and cooperate in conducting clinical trials as well as reporting outcomes of FSMP. This study aims to take type 2 diabetes mellitus (T2DM) as an example to develop COS for clinical trials of FSMP.Contributors
Dongyu MU 1*, Jie GONG 1, Ziqi ZHOU 1, Xile JIANG 1, Yanju LI 1, Lei SHI 1, Yuan LIU 1, Yi CHENG 1, Wen HU 1**
1. Department of Clinical Nutrition, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China
* the principal investigator
** the principal supervisors
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Literature review
- Systematic review
This COS will be developed following principles outlined by Core Outcome Set-STAndardised Protocol Items (COS-STAP) and Core Outcome Set-Standards for Development (COS-STAD) guidelines. Reporting guidance of COS for FSMP will be developed afterward. Three phases in this COS study will be as follows:
(1) Generate a list of relevant outcomes and reporting items identified from a systematic review (SR). The information sources of the SR are mainly from (a) published studies, (b) regulatory documentation and (c) stakeholder qualitative interviews. Identified outcomes and items will be categorized via a conceptual framework and formatted into the 1st round of Delphi survey questionnaire items.
(2) Perform at least two consecutive rounds of Delphi surveys among stakeholders invited by the working group of Core Outcome sets and Core Outcome measurement sets in NUTriology (COCONUT) to create the COS for future clinical trials of FSMP. COCONUT will invite patients, clinical dietitians, physicians, COS researchers, journal editors, FSMP manufacturers, and regulatory representatives to score each reporting item and outcome from the aspects of importance, operability, independence and cost.
(3) Hold a face-to-face consensus meeting to refine the content of the COS. Key stakeholders will be invited to attend the consensus meeting to discuss and agree the final content of the reporting guidance and COS(s).