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Core outcome sets, clinical trials, development, China
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Zhang M, Zhang C, Pang B et al. Development status of core outcome sets in China: a protocol [version 1; peer review: awaiting peer review]. F1000Research 2025, 14:206 (https://doi.org/10.12688/f1000research.159399.1)
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Study Protocol
Development status of core outcome sets in China: a protocol
[version 1; peer review: awaiting peer review]
PUBLISHED 14 Feb 2025
OPEN PEER REVIEW
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Abstract
Corresponding authors:
Paula Williamson, Junhua Zhang
Competing interests:
No competing interests were disclosed.
Grant information:
This work was supported by the National Natural Science Foundation of China (No.82374619; No.81904056).
Copyright:
© 2025 Zhang M et al.
This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Zhang M, Zhang C, Pang B et al. Development status of core outcome sets in China: a protocol [version 1; peer review: awaiting peer review]. F1000Research 2025, 14:206 (https://doi.org/10.12688/f1000research.159399.1)
First published: 14 Feb 2025, 14:206 (https://doi.org/10.12688/f1000research.159399.1)
Latest published: 14 Feb 2025, 14:206 (https://doi.org/10.12688/f1000research.159399.1)
1. Introduction
A core outcome set (COS) is an agreed standardized set of outcomes that should be measured and reported, as a minimum, in all clinical trials in specific areas of health or healthcare.1 Several global initiatives, such as the World Health Organization (WHO), Cochrane Library, and GRADE Working Group, have endorsed COS in trials. According to the Guidance for the best practices for clinical trials revealed by WHO in September 2024, standardized COS is recommended to be used in all trials, to enable the results of studies to be compared, contrasted, and combined as appropriate.2
Since the concept of COS was introduced to China, there has been a growing interest in and increasing endorsement of the use of COS in health research.3 Driven by the initiatives of the Chinse Research Center for Core Outcome Sets (ChiCOS), jointly set up by the Cochrane China and Tianjin University of Traditional Chinese Medicine, a growing number of COS research projects led by Chinese researchers have been registered and carried out in recent years. In the Core Outcome Measures in Effectiveness Trial (COMET) database, the number of COS registered by Chinese researchers is increasing, and many articles related to COS have been published in journals, showing an upward trend.4,5
Previous work has reviewed the status and quality of COS studies in Chinese medicine.6–8 However, many published studies have not been registered with the COMET, or have no corresponding protocol, and there is a lack of systematic quality assessment throughout the entire process from registration to publication, including study protocols, development methods, and COS reporting. There are still key issues to be addressed, such as:
• Have these studies been registered? Where were they registered? Has the registration entry published any relevant research?
• Did the study have a publicly available protocol? How does the protocol compare to the Core Outcome Set-STAndardised Protocol Items (COS-STAP)9?
• For published studies, how do the development methods compare to the Core Outcome Set-STAndards for Development (COS-STAD)10?
• Have published studies been registered accordingly? How does their reporting compare to the Core Outcome Set-STAndards for Reporting (COS-STAR)11?
To date, there has been no thorough overview of the development status of COS in China, nor has there been an evaluation of the quality of their methods and reports. Therefore, it is crucial to systematically analyze the current situation and promote the high-quality development of COS in China, enhance the reliability of future related research, and ultimately more effectively facilitate the translation of research findings into clinical research and practice.
The aims of this study are to examine: 1) whether the COS projects led by Chinese researchers have prior registration and publicly available protocols; 2) if these COS projects were conducted with a robust methodology; and 3) how the quality of these COS studies from protocol to completed research.
2. Methods
2.1 Search of literature databases and registries
An electronic search will be conducted in the following ways:
(1) We will search the COMET database and identify COS led by Chinese researchers, including entries of all states of ongoing or completed.
(2) We will search the ChiCOS database for registered COS.
(3) Literature database including China National Knowledge Infrastructure (CNKI), China Biology Medicine Literature Service System (SinoMed), and Wanfang database for COS published in journals. The search terms of the literature database include “core outcome set,” “COS,” “core outcome measure,” “standardized outcome set,” “consensus outcome set,” “minimum dataset,” “trial endpoint set,” “common outcome measure,” etc. The literature databases and registries will be searched from its inception to November 2024.
2.3 Data screening
Identified study titles will undergo an initial screening, followed by a thorough review of the full-text articles or their registration information. Two independent investigators will assess the eligibility of the titles and abstracts. MZ will identify COS studies from the relevant databases, while CZ will verify the results. A third reviewer (BP) will be consulted in case of any discrepancies. The third reviewer will discuss with MZ or CZ to reach a consensus and resolve any disagreements.
2.4 Data extraction
(1) According to different study types, the information of the included studies will be extracted into different Excel tables. All relevant information of the included studies should be extracted, including the title, disease category, disease name, participant characteristics, interventions, author information, registration/publication year, etc. For protocol and completed research, additionally extract their basic literature characteristics, including the journal, article type, publication year, study methods, abstract, introduction, background and objectives, context of use, registered protocol, consensus process, outcome measures, consensus definitions, ethical approval and informed consent, limitations, funding sources, and conflicts of interest.
(2) We will conduct a comparative analysis to determine how many entries in the ChiCOS database have not been registered in the COMET database.
(3) In order to ensure the accuracy of data extraction, two researchers (MZ and CZ) independently conducted data extraction, cross-checked for accuracy and consensus, and then conducted descriptive analysis.
2.5 Quality evaluation
We will refer to a series of guidelines set by COMET, including COS-STAR, COS-STAP, and COS-STAD, to assess the quality of the included COS. The percentages of qualified items will be calculated, and a descriptive analysis will ultimately be used to summarize the findings. For protocol, we will check the quality with COS-STAP. For completed research, we will check the quality with COS-STAR and COS-STAD. MZ will independently complete the evaluation process, and another researcher, CZ, will conduct sampling verification. The two individuals will cross-check the results and consult the third researcher, BP, to make a decision in case of inconsistency.
2.6 Data analysis
The findings of the review will be presented descriptively. We will count the number of studies that meet the corresponding evaluation criteria. Figure 1 shows the flowchart of the research process.
Figure 1. The flowchart of the research process.
3. Discussion
The widespread use of Core Outcome Sets (COS) is crucial for improving outcome consistency across clinical trials, reducing bias, and minimizing research waste. Given the universal challenge of outcome inconsistency in clinical trials, awareness of COS development and utilization among Chinese researchers has increased significantly over the past decade. Notably, the Chinese organization ChiCOS, which specializes in COS, was established in 2019 and has formed connections with COMET. This study aims to provide an overview of the status of COS developed by Chinese researchers. Additionally, it will provide evidence regarding the quality of COS projects led by Chinese researchers. Understanding these aspects is essential for identifying the barriers and facilitators to COS development in China.
Study registration
This research is registered in Core Outcome Measures in Effectiveness: https://www.comet-initiative.org/Studies/Details/3277.
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how to cite this article
Zhang M, Zhang C, Pang B et al. Development status of core outcome sets in China: a protocol [version 1; peer review: awaiting peer review]. F1000Research 2025, 14:206 (https://doi.org/10.12688/f1000research.159399.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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