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other·endocrinology, clinical nutrition, research methods, nutrition, systematic review·PMC10037765

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

Trials · 7 authors, 5 centres

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This is a study protocol describing the methodology for developing a core outcome set (COS) for clinical trials of Food for Special Medical Purposes (FSMP) designed for type 2 diabetes mellitus.

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This is a study protocol describing the methodology for developing a core outcome set (COS) for clinical trials of Food for Special Medical Purposes (FSMP) designed for type 2 diabetes mellitus. Limitations noted include the potential for limited international applicability, as the study is not international, and the challenge of achieving consensus among diverse stakeholder groups. The implications are that a successful COS could standardize outcome measurement in FSMP trials for T2DM, improving communication and efficiency in research and regulation.

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other

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endocrinology

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AI pipeline

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ORIGINAL PAPER

PMC10037765

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

Trials

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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 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. Trial registration COMET (1547). Registered on March 23, 2020. Supplementary Information The online version contains supplementary material available at 10.1186/s13063-023-07214-2.

CITATION EXPORT

Dongyu Mu, Jie Gong, Yaoyao Wei et al.. Development of core outcome sets of Food for Special Medical Purposes designed for type 2 diabetes mellitus: a study protocol. Trials. (2023). https://doi.org/10.1186/s13063-023-07214-2

AUTHORS

7 · 5 CENTRES

Dongyu Mu, Jie Gong, Yaoyao Wei, Muxi Chen, Jiajie Yu, Liang Du, Wen Hu

1grid.412901.f0000 0004 1770 1022Department of Clinical Nutrition, West China Hospital, Sichuan University, #37 Guoxue Alley, Wuhou District, Chengdu, 610041 Sichuan Province People’s Republic of China
2grid.13291.380000 0001 0807 1581West China School of Public Health, Sichuan University, Chengdu, 610041 People’s Republic of China
3grid.13291.380000 0001 0807 1581West China School of Medicine, Sichuan University, Chengdu, 610041 People’s Republic of China
4grid.412901.f0000 0004 1770 1022The Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041 People’s Republic of China
5grid.412901.f0000 0004 1770 1022West China Medical Publishers, West China Hospital, Sichuan University, Chengdu, 610041 People’s Republic of China