F1000ResearchF1000Research2046-1402F1000 Research LimitedLondon, UK10.12688/f1000research.159399.1Study ProtocolArticlesDevelopment status of core outcome sets in China: a protocol
[version 1; peer review: awaiting peer review]
ZhangMingyanConceptualizationData CurationFormal AnalysisFunding AcquisitionMethodologyProject AdministrationResourcesVisualizationWriting – Original Draft PreparationWriting – Review & Editinghttps://orcid.org/0000-0002-4413-778412ZhangChenyaoWriting – Review & Editing2PangBoData CurationValidation2GorstSarahResourcesValidationhttps://orcid.org/0000-0002-7818-96463WilliamsonPaulaConceptualizationMethodologyProject AdministrationResourcesWriting – Review & Editinga3ZhangJunhuaMethodologyProject AdministrationResourcesWriting – Review & Editingb2
Chinese Medicine School, Tianjin University of Traditional Chinese Medicine, Tianjin, Tianjin, 301617, China
NMPA Key Laboratory for Evidence-Based Evaluation of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, 301617, China
University of Liverpool, Liverpool, L69 3GL, UKprw@liverpool.ac.ukzjhtcm@foxmail.com
Awareness of COS development and use among Chinese researchers has increased since the concept was introduced in China in 2012. An increasing number of COS have been registered and completed by Chinese developers. The status of relevant COS research led by Chinese researchers and their quality remains unclear.
Methods
An electronic search will be conducted in the COMET, ChiCOS, and Chinese literature databases (CNKI, WanFang, and SinoMed). According to different study types (registration entry, protocol, or completed research), the information of the included studies will be extracted into different Excel tables. The extracted information depends on the type of study. The findings of the review will be presented descriptively. For protocol, we will check the quality with COS-STAP. For completed research, we will check the quality with COS-STAR and COS-STAD. In addition, we will conduct a comparative analysis to determine how many entries in the ChiCOS database have not been registered in the COMET database.
Discussion
This study will provide valuable insights into the current state of COS in China. This is essential for a better understanding of the barriers and facilitators to COS development and application.
Study registration
This research is registered in Core Outcome Measures in Effectiveness:
https://www.comet-initiative.org/Studies/Details/3277.
Core outcome setsclinical trialsdevelopmentChinathe National Natural Science Foundation of ChinaNo.82374619;No.81904056This work was supported by the National Natural Science Foundation of China (No.82374619; No.81904056). 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. Methods2.1 Search of literature databases and registries
An electronic search will be conducted in the following ways:
We will search the COMET database and identify COS led by Chinese researchers, including entries of all states of ongoing or completed.
We will search the ChiCOS database for registered COS.
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.
2.2 Inclusion criteria
Studies (registration entry, protocol, or completed research) will be included if their primary objective is to develop a COS.
The first author is affiliated with an institution located in China.
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
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.
We will conduct a comparative analysis to determine how many entries in the ChiCOS database have not been registered in the COMET database.
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.
The flowchart of the research process.
2.7 Study status
This study has not yet commenced.
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.
Data availability statementUnderlying data
No data are associated with this article.
Extended data
Zenodo: Development status of core outcome sets in China: a protocol,
https://doi.org/10.5281/zenodo.14609737.
12
This project contains the following underlying data:
PRISMA-P checklist.docx
Data are available under the terms of the
Creative Commons Attribution 4.0 International license (CC-BY 4.0).
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