Uptake of core outcome sets by clinical trialists in China: a protocol

Ruijin Qiu; Xiaodan Fan; Wenhui Wang; Mike Clarke; Zhuo Chen; Shuling Liu; Paula Williamson; Hongcai Shang

doi:10.12688/f1000research.139282.3

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Study Protocol

Revised

Uptake of core outcome sets by clinical trialists in China: a protocol

[version 3; peer review: 2 approved]

Ruijin Qiu^1,2, Xiaodan Fan², Wenhui Wang³, [...] Mike Clarke⁴, Zhuo Chen², Shuling Liu², Paula Williamson¹, Hongcai Shang²

Ruijin Qiu^1,2, Xiaodan Fan², [...] Wenhui Wang³, Mike Clarke⁴, Zhuo Chen², Shuling Liu², Paula Williamson¹, Hongcai Shang²

PUBLISHED 17 Jul 2024

Author details Author details

¹ Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, Beijing, China
² University of Liverpool, Liverpool, England, UK
³ College of Integrated Chinese and Western Medicine, Hunan University of Chinese Medicine, Changsha, China
⁴ Queen's University Belfast, Belfast, Northern Ireland, UK

Ruijin Qiu
Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing

Xiaodan Fan
Roles: Data Curation, Investigation, Resources

Wenhui Wang
Roles: Data Curation, Investigation, Resources

Mike Clarke
Roles: Conceptualization, Methodology, Writing – Review & Editing

Zhuo Chen
Roles: Data Curation, Investigation, Resources

Shuling Liu
Roles: Data Curation, Investigation, Resources

Paula Williamson
Roles: Conceptualization, Funding Acquisition, Methodology, Validation, Writing – Review & Editing

Hongcai Shang
Roles: Conceptualization, Funding Acquisition, Methodology, Supervision

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the All trials matter collection.

Abstract

Background

The concept of core outcome sets (COS) has been introduced in China for about 10 years. In recent years, some Chinese researchers also committed to developing COS, though the majority of COS are ongoing. However, there were more than 500 published COS for research in the COMET database by 2020. The extent of availability of COS for the top 25 diseases with the highest burden in China is unknown. In addition, the uptake of COS in clinical trials for these diseases is unknown, along with the knowledge, perceptions, and views of the clinical trialist community in China on the use of COS in relation to choosing outcomes for their research.

Methods

The main burden of disease in China will be identified. Then we will search the COMET database to identify if there are ongoing or completed relevant COS research A COS published since 2012 would be preferred to one published before 2012 for the analysis of COS uptake if one meets the eligibility criteria. We will extract scopes of published eligible COS, including condition, population, interventions, and core outcomes. Then we will search the Chinese Clinical Trial Registry using disease names for each disease that has a published COS. We will assess the overlap in scope between clinical trials and COS. Then we will conduct an online survey and semi-structured interviews to identify the knowledge and perceptions of COS among primary investigators of included clinical trials.

Discussion

This research will fill in gaps between COS and the burden of disease in China. Understanding clinical trialists’knowledge and perceptions of COS may help dissemination and application of COS in the future.

Trial registration

This research is registered in Core Outcome Measures in Effectiveness: https://www.comet-initiative.org/Studies/Details/2563.

Keywords

Core outcome sets; clinical trialists; uptake

Corresponding authors: Paula Williamson, Hongcai Shang

Competing interests: PRW and MC are members of the COMET (Core Outcome Measures in Effectiveness Trials) Management Group.

Grant information: This study was supported by the National Natural Science Foundation of China (81904051) to RQ; the Young Elite Scientists Sponsorship Program by CACM (CACM-2019-NRC2-A03) to RQ; the National Institute for Health Research (NIHR) Senior Investigator Award (NF-SI_0513-10025) to PW; the MRC Trials Methodology Research Partnership (grant reference MR/S014357/1) to PW; and the Qihuang Scholar of National Administration of Traditional Chinese Medicine (RS086) to HS. The views expressed in this article are those of the authors and not necessarily those of the NIHR, or the Department of Health and Social Care. Funding for the translation of articles was provided by the University of Liverpool.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2024 Qiu R 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: Qiu R, Fan X, Wang W et al. Uptake of core outcome sets by clinical trialists in China: a protocol [version 3; peer review: 2 approved]. F1000Research 2024, 12:1030 (https://doi.org/10.12688/f1000research.139282.3) First published: 23 Aug 2023, 12:1030 (https://doi.org/10.12688/f1000research.139282.1) Latest published: 17 Jul 2024, 12:1030 (https://doi.org/10.12688/f1000research.139282.3)

Revised Amendments from Version 2

A few errors have been changed.

See the authors' detailed response to the review by Kim Thomas and Emma Campbell
See the authors' detailed response to the review by Zehuai Wen

1.

Background

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 health care.¹ The concept of COS was introduced in China in 2013.² Chinese researchers have registered more than 80 COS for research in the Core Outcome Measures in Effectiveness Trials (COMET) database by 2022.

A search of the COMET database shows that more than 500 completed COS studies have been published by 2021. The number of COS varies by disease category. The top five disease categories are cancer, rheumatology, neurology, heart and circulation, orthopaedics and trauma.³ However, the number of candidates vary by disease category. In addition, there are more than one COS for some conditions, while no COS exists in some other important conditions. Whether there are gaps between COS research and the burden of disease in China remains unclear.

There are some benefits to using COS in clinical trials, which include improving the consistency of outcome reporting, increasing the relevance of outcomes measured to decision-makers, and helping to identify potential selective outcome reporting bias. However, previous research has shown that COS uptake is low in most research areas.⁴^,⁵ Research shows that clinical trialists’ awareness and understanding of COS may facilitate the use of COS.⁶ However, Chinese clinical trialists’ awareness, understanding and using of COS are unknown.

The aims of this study are to examine: (1) whether the top 25 diseases with the highest burden in China have relevant COS; (2) the use of COS in clinical trials registered in the Chinese Clinical Trial Registry for these 25 diseases; and (3) views of these clinical trialists on the knowledge, perceptions, and use of COS in relation to choosing outcomes, as well as barriers and facilitators to uptake of COS.

2.

Methods

Mapping of burden of disease in China to COS

2.1

2.1.1 Identification of diseases for study

The top 25 causes of disability-adjusted life-years (DALY) in China in 2019 have been identified from the tool of Global Burden of Disease (GBD).⁷ Two researchers (RQ and XF) will also discuss subtypes of disease according to practice guidelines or textbook of internal medicine if necessary. The initial list of diseases for the study is shown in Table 1.

Table 1. The initial list of diseases for the study (ranked by number of disability-adjusted life-years).

Disease category	Burden of disease	Subtypes of disease
Neurology	Stroke	Ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage
Heart & circulation	Ischaemic heart disease	Angina pectoris, acute coronary syndrome, myocardial infarction
Lungs & airways	Chronic obstructive pulmonary diseases	/
Cancer	Tracheal, bronchus, and lung cancer	/
Orthopaedics & trauma	Road injuries	/
Ear, nose, & throat	Age-related hearing loss	/
Orthopaedics & trauma	Low back pain	/
Endocrine & metabolic	Diabetes mellitus type 2	Diabetes mellitus type 2
Cancer	Stomach cancer	/
Neurology	Migraine	/
Mental disorders	Depressive disorders	Depression, dysthymia
Orthopaedics & trauma	Falls
Neonatal	Neonatal disorders	Neonatal preterm birth Neonatal encephalopathy due birth asphyxia and trauma Neonatal sepsis and other neonatal infections Hemolytic disease and other neonatal jaundice Other neonatal disorders
Orthopaedics & trauma	Neck pain
Cancer	Colon and rectum cancer	Colorectal cancer
Muscle disease	Other musculoskeletal disorders	Exclude: osteoarthritis, rheumatoid arthritis
Neurology	Alzheimer's disease and other dementias	Alzheimer’s disease Dementia
Kidney disease	Chronic kidney disease	Chronic kidney disease due to diabetes mellitus type 1 Chronic kidney disease due to diabetes mellitus type 2 Chronic kidney disease due to hypertension Chronic kidney disease due to glomerulonephritis Chronic kidney disease due to other and unspecified causes
Cancer	Esophageal cancer	/
Heart & circulation	Hypertensive heart disease	/
Cancer	Liver cancer	Liver cancer due to hepatitis B, liver cancer due to hepatitis C, liver cancer due to alcohol use, liver cancer due to NASH, liver cancer due to other causes
Infectious disease	Total burden related to hepatitis B	/
Sense organ diseases	Blindness and vision loss	Glaucoma, cataract, age-related macular degeneration, refraction disorders, near vision loss, other vision loss
Muscle disease	Osteoarthritis	/
Mental disorders	Anxiety disorders	/

2.1.2 Identification of relevant COS

We will manually search the COMET database and identify all COS for diseases/subtypes in the diseases list. We will identify if there are ongoing or completed relevant COS research. The study began on April 7^th, 2023 and is ongoing.

2.1.3 Inclusion criteria for COS

(1) The scope appears relevant to a disease in the diseases list;
(2) COS for research should have included patient participants;

RQ will identify COS from the COMET database, and XF will check the results. Any discrepancies will be resolved by consensus discussion or by consulting a third reviewer (PW). RQ and PW will discuss all the COS for the 25 causes of DALY and determine which COS are eligible. The criterion related to the inclusion of patient participants follows previous work examining uptake of specific COS, and reflects the impact of patient participation on the choice of core outcomes.⁸

The aim of COS is to promote a single unified approach to evaluating outcomes in a given condition throughout the world, however only 30% of COS published up to the end of 2021 have included participants from anywhere in Asia,⁸ and the majority of COS developed in China are focused on traditional Chinese medicine (TCM). To explore whether the uptake of COS is influenced by whether it was developed by Chinese researchers, we will additionally include a COS published in a Chinese language journal if one meets the inclusion criteria above.

2.1.4 Data extraction

We will describe the number of ongoing and published COS for the highest burden of disease in China. Full texts will be retrieved for published COS only.

Previous COMET systematic reviews, and ongoing inclusion of published COS by COMET, will be used for details of published COS relevant to this work. Data extraction will include the intended use of recommendations, disease category, disease name, population characteristics (age, sex), interventions, geographical locations of COS developers, geographical locations of COS participants will be extracted, and whether patients participated.

2.1.5 Data analysis

Descriptive analysis will be used for general characteristics of COS.

Exploring uptake of COS in trialists in China

2.2

2.2.1 Identification of clinical trials in the Chinese Clinical Trial Registry

We will search the Chinese Clinical Trial Registry (https://www.chictr.org.cn/historyversionpub.aspx) according to the disease name extracted for the published COS.

2.2.2 Inclusion and exclusion criteria for clinical trials

Inclusion criteria for clinical trials:

(1) Randomised and non-randomised clinical trials;
(2) The objectives of clinical trials are for disease therapy;
(3) The prospective registration time should be in 2021 and 2022.

Exclusion criteria for clinical trials: The clinical trials are to assess the mechanisms of effect of interventions.

If the disease name in the COS is broader, we will further search subtypes of disease. RQ and XF will discuss the list of subtypes of disease, any disagreement will be discussed with a third investigator (HS). XF, WW, ZC, and SL will search for clinical trials from the Chinese Clinical Trial Registry and apply the inclusion and exclusion criteria to identify the eligible clinical trials. RQ will check the results.

2.2.3 Comparison of COS with clinical trials

Inclusion criteria:

(1) An eligible COS exists published since 2012.
(2) The number of clinical trials with matching scope to an eligible COS is not less than 40.

A COS published since 2012 would be preferred to one published before 2012 for the analysis of COS uptake if one meets the eligibility criteria. A COS developed by Chinese researchers may be significant for Chinese clinical trialists. If there is an eligible COS developed by Chinese researchers, it will be included. If it does not meet the inclusion criteria for comparison of COS with clinical trials, then the prospective registration time for clinical trials will be expanded.

An online survey will be sent to trialists who registered clinical trials which are relevant to a specific COS. We anticipate a 50% non-response rate, thus if the number of trials is too small, it will be difficult to obtain a reasonable spread of perspectives from trialists about the use of the relevant COS. It was felt that responses from 20 trialists would be helpful based on a typical number of participants involved in qualitative research, thus requiring an anticipated 40 registered trials.

2.2.4 Data extraction and analysis

Data extraction for COS will include: author, title, publication time, condition, population, intervention, outcomes, and outcome measurement instruments (if applicable).

Contact details of trialists (including applicant’s name, the registration contact person’s email and telephone number, the primary investigator’s name, the primary investigator’s email and telephone number) will be extracted, because they will be invited to participate in the online survey. The other data extracted will include: title, the primary investigator’s institutions, study type, disease name, population, intervention, outcomes, and outcome measurement instruments.

For comparing trial outcomes and COS, only published COS will be used. If there are more than two COS for a specific disease, the differences in scope between these COS will be discussed by two reviewers.

We will compare the overlap in scope between clinical trials and COS according to the framework used in previous research.⁹ The framework is shown in Table 2.

Table 2. The framework for assessing overlap in scope between clinical trials and COS.

		Intervention
		COS is narrow	Exact match	COS is broader	Different intervention
Population	COS is narrow	A	B	C	D
	Exact match	E	F	G	H
	COS is broader	I	J	K	L
	Different subgroup of the population	M	N	O	P

We will calculate the median percentages of outcomes in each clinical trial that were specific matches, general matches, and non-matches with outcomes in each relevant COS. We will calculate the proportion of outcomes that overlap between the COS and clinical trials for each disease.

Exploring awareness, barriers and facilitators to uptake COS by trialists

2.3

2.3.1 Online survey

2.3.1.1 The process of online survey

A survey will be sent to clinical trialists who have registered or completed a clinical trial that has overlapped scope between the trial and COS. We will identify the primary investigator’s name, email, and telephone number when we extract eligible clinical trials from the Chinese Clinical Trial Registry. We will send a Chinese translation of the COS deemed relevant to the trialists’ trials with questionnaire. When the primary investigators cannot be contacted via emails, the applicants for registration will be approached. We will examine trialists’ knowledge and awareness of COS. An online survey will be sent to clinical trialists, with one of three versions of the survey: 1) clinical trialists who report a full COS in their clinical trials; 2) clinical trialists who report only a few of outcomes in the COS; and 3) clinical trialists who do not report any outcome in the COS.

The survey will include both closed and open-ended questions. General information, such as gender, age, participants’ role (clinicians or researcher), specialty (traditional Chinese medicine, integrative medicine, or Western medicine), work experience, geographical area, professional qualification, and educational background will be collected. We will refer to the facilitators and barriers identified in previous research, including using of COS and clinical practice guidelines,¹⁰^,¹¹ to develop open and closed questions to ask all participants. MK, PW, and RQ will discuss the questions in the questionnaires. The survey and other tools will be distributed into Chinese. RQ will translate tools into Chinese and the translation will then be sent to several researchers who have experience in COS research from a Chinese authors’ team and we will ask them to give comments. RQ, SL, ZC, and WW will discuss and determine the translation before distribution.

The structured questions in the survey are shown in extended data.

At the end of each survey, we will ask the trialists if they would like to attend a semi-structured interview.

2.3.1.2 Data analysis

Closed questions will be analyzed using descriptive statistics. Ratings for the barriers and facilitators to uptake will be summarized in terms of the median, range, and interquartile range. For open questions, thematic analysis will be used. All free text will be extracted in to a word document which RQ will read multiple times to organize the text into some initial themes and the author team will review the data and its assignment to the themes identified. The reason why the trialists used or did not use COS will be analyzed by content analysis. New suggested potential barriers and facilitators will be mapped to different themes.

2.3.2 Semi-structured interviews

2.3.2.1 The process of semi-structured interviews

We will invite trialists who agree to be interviewed to attend an in-person or online interview, if saturation is reached, the interviews will be completed. The COS publication, translated into Chinese, will be sent to them before the interview. The topic guide is as follows:

1. How many years of experience do you have in the design, management, or analysis clinical trials?
2. How many clinical trials did you participate in the design, management, or analysis?
3. When you design a clinical trial, how did you choose outcomes?
4. Do you know what is COS?
5. Are you familiar with COS?
6. Can you define COS?
7. How comfortable you are with English?
8. How did you become familiar with COS?
9. If there is a relevant COS in your research area, do you want to use it? Why?
10. Whether you know the COS that we sent you? Will you use it in your next trial?
11. What kind of facilitators and barriers for you to use a COS in clinical trial?
12. In your opinion, what should be done to improve the use of COS?

2.3.2.2 Data analysis

General characteristics of interviewees will be presented using descriptive methods. The trialist’s awareness of, and decisions to search for and use a COS will be described, and the reasons why trialists used or did not use COS will be analyzed by content analysis.

Dissemination

2.4

The finding of this research will be disseminated through conferences, peer-reviewed publication, and social media.

3.

Discussion

COS have been introduced in China for about 10 years. Chinese trialists’ knowledge and awareness of using COS are important to COS developers in China. This study will provide information on the proportion of trialists in China who registered clinical trials in the Chinese Clinical Trial Registry in the areas with the highest burden of disease, and how the outcomes they chose compare to existing COS.

COS are very important for reducing heterogeneity of outcome reporting, potential bias, and research waste when they are used in clinical trials. There are hundreds of COS published in the world. Chinese researchers are also developing COS in some health areas, whether there is a gap between COS and the burden of disease in China remains unclear. This research will provide evidence relevant to COS researchers and clinical trialists.

Ethics and consent

The project has been approved by the Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine (2023DZMEC-175-01). The ethical approval agreed to not getting written informed consent from the participants, because they are clinical trialists.

Trial registration: This research is registered in Core Outcome Measures in Effectiveness: https://www.comet-initiative.org/Studies/Details/2563.

Data availability statement

Underlying data

No data are associated with this article.

Extended data

DANS-EASY; Questionnaire of trialists’ perceptions in COS. https://doi.org/10.17026/dans-ze4-tby3.¹²

This project contains the following extended data:

• Questionnaire of trialists’ perceptions in COS(1).pdf. (English version of survey).

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

Acknowledgments

We thank the China Scholarship Council for supporting this research. We are grateful to Jamlick Karumbi, from the University of Liverpool for his share on the experience of developing questionnaire.

References

1. The COMET initiative. [Accessed March 26, 2024]. Reference Source
2. Zhang L, Zhang J, Chen J, et al.: Clinical research of traditional chinese medicine needs to develop its own system of core outcome sets. Evid. Based Complement. Alternat. Med. 2013; 2013: 202703.
3. Gargon E, Gorst SL, Matvienko-Sikar K, et al.: Choosing important health outcomes for comparative effectiveness research: 6th annual update to a systematic review of core outcome sets for research. PLoS One. 2021; 16(1): e0244878. PubMed Abstract | Publisher Full Text | Free Full Text
4. Williamson PR, Barrington H, Blazeby JM, et al.: Review finds core outcome set uptake in new studies and systematic reviews needs improvement. J. Clin. Epidemiol. 2022; 150: 154–164. Publisher Full Text
5. Matvienko-Sikar K, Avery K, Blazeby JM, et al.: Use of core outcome sets was low in clinical trials published in major medical journals. J. Clin. Epidemiol. 2022; 142: 19–28. PubMed Abstract | Publisher Full Text
6. Hughes KL, Williamson PR, Young B: In-depth qualitative interviews identified barriers and facilitators that influenced chief investigators’ use of core outcome sets in randomised controlled trials. J. Clin. Epidemiol. 2022; 144: 111–120. PubMed Abstract | Publisher Full Text | Free Full Text
7. Institute for Health Metrics and Evaluation. [Accessed March 26, 2024]. Reference Source
8. Dodd S, Gorst SL, Young A, et al.: Patient participation impacts outcome domain selection in core outcome sets for research: an updated systematic review. J. Clin. Epidemiol. 2023; 158:127–133. PubMed Abstract | Publisher Full Text
9. Saldanha IJ, Dodd S, Gorst SL, et al.: More than half of systematic reviews have relevant core outcome sets. J. Clin. Epidemiol. 2021; 136: 168–179. PubMed Abstract | Publisher Full Text | Free Full Text
10. Hughes KL, Williamson PR, Young B: In-depth qualitative interviews identified barriers and facilitators that influenced chief investigators’ use of core outcome sets in randomised controlled trials. J. Clin. Epidemiol. 2022; 144: 111–120. PubMed Abstract | Publisher Full Text | Free Full Text
11. Ciro Correa V, Helena Lugo-Agudelo L, Camilo Aguirre-Acevedo D, et al.: Individual, health system, and contextual barriers and facilitators for the implementation of clinical practice guidelines: a systematic metareview.
12. Qiu R: Questionnaire of trialists’ perceptions in COS. Dataset. DANS. 2023. Publisher Full Text

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Version 3

VERSION 3 PUBLISHED 23 Aug 2023

Author details Author details

Ruijin Qiu
Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing

Xiaodan Fan
Roles: Data Curation, Investigation, Resources

Wenhui Wang
Roles: Data Curation, Investigation, Resources

Mike Clarke
Roles: Conceptualization, Methodology, Writing – Review & Editing

Zhuo Chen
Roles: Data Curation, Investigation, Resources

Shuling Liu
Roles: Data Curation, Investigation, Resources

Paula Williamson
Roles: Conceptualization, Funding Acquisition, Methodology, Validation, Writing – Review & Editing

Hongcai Shang
Roles: Conceptualization, Funding Acquisition, Methodology, Supervision

Competing interests

PRW and MC are members of the COMET (Core Outcome Measures in Effectiveness Trials) Management Group.

Grant information

This study was supported by the National Natural Science Foundation of China (81904051) to RQ; the Young Elite Scientists Sponsorship Program by CACM (CACM-2019-NRC2-A03) to RQ; the National Institute for Health Research (NIHR) Senior Investigator Award (NF-SI_0513-10025) to PW; the MRC Trials Methodology Research Partnership (grant reference MR/S014357/1) to PW; and the Qihuang Scholar of National Administration of Traditional Chinese Medicine (RS086) to HS. The views expressed in this article are those of the authors and not necessarily those of the NIHR, or the Department of Health and Social Care. Funding for the translation of articles was provided by the University of Liverpool.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Article Versions (3)

version 3

Revised

Published: 17 Jul 2024, 12:1030

https://doi.org/10.12688/f1000research.139282.3

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Published: 28 Mar 2024, 12:1030

https://doi.org/10.12688/f1000research.139282.2

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https://doi.org/10.12688/f1000research.139282.1

© 2024 Qiu R 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.

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Qiu R, Fan X, Wang W et al. Uptake of core outcome sets by clinical trialists in China: a protocol [version 3; peer review: 2 approved]. F1000Research 2024, 12:1030 (https://doi.org/10.12688/f1000research.139282.3)

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Reviewer Report 05 Apr 2024

Kim Thomas, Centre of Evidence Based Dermatology, School of Medicine, University of Nottingham, Nottingham, UK

Emma Campbell, Centre of Evidence Based Dermatology, School of Medicine, University of Nottingham, Nottingham, UK

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Reviewer Report 28 Feb 2024

Kim Thomas, Centre of Evidence Based Dermatology, School of Medicine, University of Nottingham, Nottingham, UK

Emma Campbell, Centre of Evidence Based Dermatology, School of Medicine, University of Nottingham, Nottingham, UK

Approved with Reservations

https://doi.org/10.5256/f1000research.152547.r243145

Uptake of core outcome sets by clinical trialists in China: a protocol

Thank you for asking for a review of this interesting study protocol. Overall, the protocol is well written.

The authors ... Continue reading

Determine whether ongoing and completed COS are relevant to the disease burden in China.
Find out whether clinical trialists in China use published COS in their trials.

They have identified the top 25 disease categories in China, based on the number of disability-adjusted life years (DALYs). They plan to search the COMET database to find ongoing and published Core Outcome Sets (COS) that have been added since 2012, that are relevant to these 25 disease categories.
They will also search the Chinese Clinical Trial Registry to identify clinical trials (registered 2021-2022) in the 25 disease categories that list outcomes that match the outcomes in the disease-specific COS. This will give an indication of whether ongoing and completed COS are relevant to the disease burden in China.

For further analysis, individual clinical trials will be analysed to see whether an appropriate COS exists for the disease in question. Each trial also has to meet the inclusion criteria of there being at least 40 clinical trials that match to each specific COS. Lead investigators of the selected clinical trials will then be surveyed, and some will be interviewed, on their views of COS.

This is an ambitious study that will provide an interesting insight into COS uptake in China. It is actually three studies in one:

1. Mapping of burden of disease in China to published COS.
2. Exploring uptake of COS in trials registered on the Chinese clinical trials registry.
3. Mixed methods study to establish awareness, barriers and facilitators to COS uptake (including both an initial survey and subsequent interview study).

It might have been helpful to describe these three aspects separately, with specific aims, objectives and methods for each. Not all of the studies aims and objectives are clearly articulated in the existing two aims.

The authors suggest that specific COS may be required to evaluate interventions testing Chinese Medicine and that uptake of COS developed in China might be higher than uptake of COS developed internationally. I am a little worried that such a stance goes against the very essence of what COS initiatives are trying to do. Namely to promote a single unified approach to evaluating outcomes in a given condition throughout the world. I am not yet convinced that a COS specific to Chinese Medicine is helpful or required.

The approach of focussing on the top 25 diseases by burden of disease in China is interesting and should help to focus the study, although this still represents a lot of work. It is not clear why only COS published since 2012 are included. If a disease category has a gold-standard COS that was published pre-2012 (e.g the work of the OMERACT group), this protocol would count the disease category as having no COS, which seems a shame.

It is proposed that the COS identified through a search of the COMET database will be evaluated for quality. Whilst this is a laudable ambition, there was very little detail provided as to exactly how this would be done and what the cut-off for meeting the quality standard might be. Rather than excluding COS based on their quality status, I wonder if it would be more useful to include all identified COS, and to report the quality ratings descriptively. At least this information would then be in the public domain and could avoid wasted effort of people repeating these quality assessments.
One of the specified inclusion criteria for study 2 (uptake of COS in clinical trials and studies) required that there be “not less than 40 trials for a given condition”. It might be helpful to add an explanation as to why this was included. If trials are only included in cases where at least 40 of them match a specific COS, the authors are not capturing up to 39 trials per disease category.

Similarly, in the section describing data extraction, it might be helpful to signpost to the fact that study 3 will require the contact details of clinical trialist who have been identified in study 2. Otherwise, the reader is left wondering why this information was being extracted from the registry data.

In the data extraction section, it states that ‘data will be retrieved from previous COMET systematic reviews’ but it is not clear how this information will be used in the protocol.

We have suggested a few minor wording amendments to improve readability:

Background

Suggest amend to: “There are some benefits to using COS in clinical trials, which include improving the consistency of outcome reporting, increasing the relevance of outcomes measured to decision-makers, and helping to identify potential selective outcome reporting bias.”

Methods

Confusing typo in survey section says ‘A survey will be sent to clinical trialists who will conduct a clinical trial’ – should this be ‘A survey will be sent to clinical trialists who have conducted a clinical trial’?

In the survey, there is a question about whether the respondent is a working in Traditional Chinese Medicine, Integrative Medicine or Western Medicine. Integrative Medicine is not mentioned anywhere in the protocol.

We wish the authors good luck with conducting this study and look forward to reading the results.

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: KT is a member of the Executive Group for The Harmonizing Outcome Measures for Eczema and sits on the Methods Committee for the C3 initiative.I confirm that this potential conflict of interest did not affect my ability to write an objective and unbiased review of the article.

Reviewer Expertise: Applied health research, core outcome sets, development and validation of outcome instruments

We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however we have significant reservations, as outlined above.

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Author Response 12 Apr 2024

Ruijin Qiu, University of Liverpool, Liverpool, UK

12 Apr 2024

Author Response

Reviewer comment 1. This is an ambitious study that will provide an interesting insight into COS uptake in China. It is actually three studies in one:
Mapping of burden of ... Continue reading Reviewer comment 1. This is an ambitious study that will provide an interesting insight into COS uptake in China. It is actually three studies in one:
Mapping of burden of disease in China to published COS.
Exploring uptake of COS in trials registered on the Chinese clinical trials registry.
Mixed methods study to establish awareness, barriers and facilitators to COS uptake (including both an initial survey and subsequent interview study).
It might have been helpful to describe these three aspects separately, with specific aims, objectives and methods for each. Not all of the studies aims and objectives are clearly articulated in the existing two aims.

Author response 1. The three aims were listed in the final paragraph of the Background section, and the methods for each are described in separate subsections of the Methods section.

Reviewer comment 2. The authors suggest that specific COS may be required to evaluate interventions testing Chinese Medicine and that uptake of COS developed in China might be higher than uptake of COS developed internationally. I am a little worried that such a stance goes against the very essence of what COS initiatives are trying to do. Namely to promote a single unified approach to evaluating outcomes in a given condition throughout the world. I am not yet convinced that a COS specific to Chinese Medicine is helpful or required.
Author response 2. We did not intend to suggest that, and have included the rationale for including a COS developed by Chinese researchers in the protocol.

Reviewer comment 3. The approach of focussing on the top 25 diseases by burden of disease in China is interesting and should help to focus the study, although this still represents a lot of work. It is not clear why only COS published since 2012 are included. If a disease category has a gold-standard COS that was published pre-2012 (e.g the work of the OMERACT group), this protocol would count the disease category as having no COS, which seems a shame.
Author response 3. All COS will be analyzed in the mapping of burden of disease in China to COS. A COS published since 2012 would be preferred to one published before 2012 for the analysis of COS uptake if one meets the eligibility criteria. It has been clarified in the methods.

Reviewer comment 4. It is proposed that the COS identified through a search of the COMET database will be evaluated for quality. Whilst this is a laudable ambition, there was very little detail provided as to exactly how this would be done and what the cut-off for meeting the quality standard might be. Rather than excluding COS based on their quality status, I wonder if it would be more useful to include all identified COS, and to report the quality ratings descriptively. At least this information would then be in the public domain and could avoid wasted effort of people repeating these quality assessments.

Author response 4. We have clarified that we will use patient participation in COS development as a marker of methodological quality, with the rationale provided.

Reviewer comment 5. One of the specified inclusion criteria for study 2 (uptake of COS in clinical trials and studies) required that there be “not less than 40 trials for a given condition”. It might be helpful to add an explanation as to why this was included. If trials are only included in cases where at least 40 of them match a specific COS, the authors are not capturing up to 39 trials per disease category.

Author response 5. The online survey will be sent to trialists who registered clinical trials which are relevant to a specific COS. We anticipate a 50% non-response rate, thus if the number of trials is too small, it will be difficult to obtain a reasonable spread of perspectives from trialists about the use of the relevant COS. It was felt that responses from 20 trialists would be helpful based on a typical number of participants involved in qualitative research, thus requiring an anticipated 40 trials This rationale has been explained in the methods (2.2.3).

Reviewer comment 6. Similarly, in the section describing data extraction, it might be helpful to signpost to the fact that study 3 will require the contact details of clinical trialist who have been identified in study 2. Otherwise, the reader is left wondering why this information was being extracted from the registry data.

Author response 6. This has been explained in 2.2.4.

Reviewer comment 7. In the data extraction section, it states that ‘data will be retrieved from previous COMET systematic reviews’ but it is not clear how this information will be used in the protocol.

Author response 7. Previous COMET systematic reviews, and ongoing inclusion of published COS by COMET, will be used for details of published COS relevant to this work. Data extraction will include the intended use of recommendations, disease category, disease name, population characteristics (age, sex), interventions, geographical locations of COS developers, geographical locations of COS participants will be extracted, and whether patients participated. This has been explained in 2.1.4.

Reviewer comment 8. We have suggested a few minor wording amendments to improve readability:
Background
Suggest amend to: “There are some benefits to using COS in clinical trials, which include improving the consistency of outcome reporting, increasing the relevance of outcomes measured to decision-makers, and helping to identify potential selective outcome reporting bias.”
Methods
Confusing typo in survey section says ‘A survey will be sent to clinical trialists who will conduct a clinical trial’ – should this be ‘A survey will be sent to clinical trialists who have conducted a clinical trial’?

Author response 8. We have made these changes in the manuscript.

Reviewer comment 9. In the survey, there is a question about whether the respondent is a working in Traditional Chinese Medicine, Integrative Medicine or Western Medicine. Integrative Medicine is not mentioned anywhere in the protocol.

Author response 9. The text has been amended.
Reviewer comment 1. This is an ambitious study that will provide an interesting insight into COS uptake in China. It is actually three studies in one:
Mapping of burden of disease in China to published COS.
Exploring uptake of COS in trials registered on the Chinese clinical trials registry.
Mixed methods study to establish awareness, barriers and facilitators to COS uptake (including both an initial survey and subsequent interview study).
It might have been helpful to describe these three aspects separately, with specific aims, objectives and methods for each. Not all of the studies aims and objectives are clearly articulated in the existing two aims.

Author response 1. The three aims were listed in the final paragraph of the Background section, and the methods for each are described in separate subsections of the Methods section.

Reviewer comment 2. The authors suggest that specific COS may be required to evaluate interventions testing Chinese Medicine and that uptake of COS developed in China might be higher than uptake of COS developed internationally. I am a little worried that such a stance goes against the very essence of what COS initiatives are trying to do. Namely to promote a single unified approach to evaluating outcomes in a given condition throughout the world. I am not yet convinced that a COS specific to Chinese Medicine is helpful or required.
Author response 2. We did not intend to suggest that, and have included the rationale for including a COS developed by Chinese researchers in the protocol.

Reviewer comment 3. The approach of focussing on the top 25 diseases by burden of disease in China is interesting and should help to focus the study, although this still represents a lot of work. It is not clear why only COS published since 2012 are included. If a disease category has a gold-standard COS that was published pre-2012 (e.g the work of the OMERACT group), this protocol would count the disease category as having no COS, which seems a shame.
Author response 3. All COS will be analyzed in the mapping of burden of disease in China to COS. A COS published since 2012 would be preferred to one published before 2012 for the analysis of COS uptake if one meets the eligibility criteria. It has been clarified in the methods.

Reviewer comment 4. It is proposed that the COS identified through a search of the COMET database will be evaluated for quality. Whilst this is a laudable ambition, there was very little detail provided as to exactly how this would be done and what the cut-off for meeting the quality standard might be. Rather than excluding COS based on their quality status, I wonder if it would be more useful to include all identified COS, and to report the quality ratings descriptively. At least this information would then be in the public domain and could avoid wasted effort of people repeating these quality assessments.

Author response 4. We have clarified that we will use patient participation in COS development as a marker of methodological quality, with the rationale provided.

Reviewer comment 5. One of the specified inclusion criteria for study 2 (uptake of COS in clinical trials and studies) required that there be “not less than 40 trials for a given condition”. It might be helpful to add an explanation as to why this was included. If trials are only included in cases where at least 40 of them match a specific COS, the authors are not capturing up to 39 trials per disease category.

Author response 5. The online survey will be sent to trialists who registered clinical trials which are relevant to a specific COS. We anticipate a 50% non-response rate, thus if the number of trials is too small, it will be difficult to obtain a reasonable spread of perspectives from trialists about the use of the relevant COS. It was felt that responses from 20 trialists would be helpful based on a typical number of participants involved in qualitative research, thus requiring an anticipated 40 trials This rationale has been explained in the methods (2.2.3).

Reviewer comment 6. Similarly, in the section describing data extraction, it might be helpful to signpost to the fact that study 3 will require the contact details of clinical trialist who have been identified in study 2. Otherwise, the reader is left wondering why this information was being extracted from the registry data.

Author response 6. This has been explained in 2.2.4.

Reviewer comment 7. In the data extraction section, it states that ‘data will be retrieved from previous COMET systematic reviews’ but it is not clear how this information will be used in the protocol.

Author response 7. Previous COMET systematic reviews, and ongoing inclusion of published COS by COMET, will be used for details of published COS relevant to this work. Data extraction will include the intended use of recommendations, disease category, disease name, population characteristics (age, sex), interventions, geographical locations of COS developers, geographical locations of COS participants will be extracted, and whether patients participated. This has been explained in 2.1.4.

Reviewer comment 8. We have suggested a few minor wording amendments to improve readability:
Background
Suggest amend to: “There are some benefits to using COS in clinical trials, which include improving the consistency of outcome reporting, increasing the relevance of outcomes measured to decision-makers, and helping to identify potential selective outcome reporting bias.”
Methods
Confusing typo in survey section says ‘A survey will be sent to clinical trialists who will conduct a clinical trial’ – should this be ‘A survey will be sent to clinical trialists who have conducted a clinical trial’?

Author response 8. We have made these changes in the manuscript.

Reviewer comment 9. In the survey, there is a question about whether the respondent is a working in Traditional Chinese Medicine, Integrative Medicine or Western Medicine. Integrative Medicine is not mentioned anywhere in the protocol.

Author response 9. The text has been amended.
Competing Interests: No competing interests were disclosed. Close
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Respond or Comment

COMMENTS ON THIS REPORT

Author Response 12 Apr 2024

Ruijin Qiu, University of Liverpool, Liverpool, UK

12 Apr 2024

Author Response

Reviewer comment 1. This is an ambitious study that will provide an interesting insight into COS uptake in China. It is actually three studies in one:
Mapping of burden of ... Continue reading Reviewer comment 1. This is an ambitious study that will provide an interesting insight into COS uptake in China. It is actually three studies in one:
Mapping of burden of disease in China to published COS.
Exploring uptake of COS in trials registered on the Chinese clinical trials registry.
Mixed methods study to establish awareness, barriers and facilitators to COS uptake (including both an initial survey and subsequent interview study).
It might have been helpful to describe these three aspects separately, with specific aims, objectives and methods for each. Not all of the studies aims and objectives are clearly articulated in the existing two aims.

Author response 1. The three aims were listed in the final paragraph of the Background section, and the methods for each are described in separate subsections of the Methods section.

Reviewer comment 2. The authors suggest that specific COS may be required to evaluate interventions testing Chinese Medicine and that uptake of COS developed in China might be higher than uptake of COS developed internationally. I am a little worried that such a stance goes against the very essence of what COS initiatives are trying to do. Namely to promote a single unified approach to evaluating outcomes in a given condition throughout the world. I am not yet convinced that a COS specific to Chinese Medicine is helpful or required.
Author response 2. We did not intend to suggest that, and have included the rationale for including a COS developed by Chinese researchers in the protocol.

Reviewer comment 3. The approach of focussing on the top 25 diseases by burden of disease in China is interesting and should help to focus the study, although this still represents a lot of work. It is not clear why only COS published since 2012 are included. If a disease category has a gold-standard COS that was published pre-2012 (e.g the work of the OMERACT group), this protocol would count the disease category as having no COS, which seems a shame.
Author response 3. All COS will be analyzed in the mapping of burden of disease in China to COS. A COS published since 2012 would be preferred to one published before 2012 for the analysis of COS uptake if one meets the eligibility criteria. It has been clarified in the methods.

Reviewer comment 4. It is proposed that the COS identified through a search of the COMET database will be evaluated for quality. Whilst this is a laudable ambition, there was very little detail provided as to exactly how this would be done and what the cut-off for meeting the quality standard might be. Rather than excluding COS based on their quality status, I wonder if it would be more useful to include all identified COS, and to report the quality ratings descriptively. At least this information would then be in the public domain and could avoid wasted effort of people repeating these quality assessments.

Author response 4. We have clarified that we will use patient participation in COS development as a marker of methodological quality, with the rationale provided.

Reviewer comment 5. One of the specified inclusion criteria for study 2 (uptake of COS in clinical trials and studies) required that there be “not less than 40 trials for a given condition”. It might be helpful to add an explanation as to why this was included. If trials are only included in cases where at least 40 of them match a specific COS, the authors are not capturing up to 39 trials per disease category.

Author response 5. The online survey will be sent to trialists who registered clinical trials which are relevant to a specific COS. We anticipate a 50% non-response rate, thus if the number of trials is too small, it will be difficult to obtain a reasonable spread of perspectives from trialists about the use of the relevant COS. It was felt that responses from 20 trialists would be helpful based on a typical number of participants involved in qualitative research, thus requiring an anticipated 40 trials This rationale has been explained in the methods (2.2.3).

Reviewer comment 6. Similarly, in the section describing data extraction, it might be helpful to signpost to the fact that study 3 will require the contact details of clinical trialist who have been identified in study 2. Otherwise, the reader is left wondering why this information was being extracted from the registry data.

Author response 6. This has been explained in 2.2.4.

Reviewer comment 7. In the data extraction section, it states that ‘data will be retrieved from previous COMET systematic reviews’ but it is not clear how this information will be used in the protocol.

Author response 7. Previous COMET systematic reviews, and ongoing inclusion of published COS by COMET, will be used for details of published COS relevant to this work. Data extraction will include the intended use of recommendations, disease category, disease name, population characteristics (age, sex), interventions, geographical locations of COS developers, geographical locations of COS participants will be extracted, and whether patients participated. This has been explained in 2.1.4.

Reviewer comment 8. We have suggested a few minor wording amendments to improve readability:
Background
Suggest amend to: “There are some benefits to using COS in clinical trials, which include improving the consistency of outcome reporting, increasing the relevance of outcomes measured to decision-makers, and helping to identify potential selective outcome reporting bias.”
Methods
Confusing typo in survey section says ‘A survey will be sent to clinical trialists who will conduct a clinical trial’ – should this be ‘A survey will be sent to clinical trialists who have conducted a clinical trial’?

Author response 8. We have made these changes in the manuscript.

Reviewer comment 9. In the survey, there is a question about whether the respondent is a working in Traditional Chinese Medicine, Integrative Medicine or Western Medicine. Integrative Medicine is not mentioned anywhere in the protocol.

Author response 9. The text has been amended.
Reviewer comment 1. This is an ambitious study that will provide an interesting insight into COS uptake in China. It is actually three studies in one:
Mapping of burden of disease in China to published COS.
Exploring uptake of COS in trials registered on the Chinese clinical trials registry.
Mixed methods study to establish awareness, barriers and facilitators to COS uptake (including both an initial survey and subsequent interview study).
It might have been helpful to describe these three aspects separately, with specific aims, objectives and methods for each. Not all of the studies aims and objectives are clearly articulated in the existing two aims.

Author response 1. The three aims were listed in the final paragraph of the Background section, and the methods for each are described in separate subsections of the Methods section.

Reviewer comment 2. The authors suggest that specific COS may be required to evaluate interventions testing Chinese Medicine and that uptake of COS developed in China might be higher than uptake of COS developed internationally. I am a little worried that such a stance goes against the very essence of what COS initiatives are trying to do. Namely to promote a single unified approach to evaluating outcomes in a given condition throughout the world. I am not yet convinced that a COS specific to Chinese Medicine is helpful or required.
Author response 2. We did not intend to suggest that, and have included the rationale for including a COS developed by Chinese researchers in the protocol.

Reviewer comment 3. The approach of focussing on the top 25 diseases by burden of disease in China is interesting and should help to focus the study, although this still represents a lot of work. It is not clear why only COS published since 2012 are included. If a disease category has a gold-standard COS that was published pre-2012 (e.g the work of the OMERACT group), this protocol would count the disease category as having no COS, which seems a shame.
Author response 3. All COS will be analyzed in the mapping of burden of disease in China to COS. A COS published since 2012 would be preferred to one published before 2012 for the analysis of COS uptake if one meets the eligibility criteria. It has been clarified in the methods.

Reviewer comment 4. It is proposed that the COS identified through a search of the COMET database will be evaluated for quality. Whilst this is a laudable ambition, there was very little detail provided as to exactly how this would be done and what the cut-off for meeting the quality standard might be. Rather than excluding COS based on their quality status, I wonder if it would be more useful to include all identified COS, and to report the quality ratings descriptively. At least this information would then be in the public domain and could avoid wasted effort of people repeating these quality assessments.

Author response 4. We have clarified that we will use patient participation in COS development as a marker of methodological quality, with the rationale provided.

Reviewer comment 5. One of the specified inclusion criteria for study 2 (uptake of COS in clinical trials and studies) required that there be “not less than 40 trials for a given condition”. It might be helpful to add an explanation as to why this was included. If trials are only included in cases where at least 40 of them match a specific COS, the authors are not capturing up to 39 trials per disease category.

Author response 5. The online survey will be sent to trialists who registered clinical trials which are relevant to a specific COS. We anticipate a 50% non-response rate, thus if the number of trials is too small, it will be difficult to obtain a reasonable spread of perspectives from trialists about the use of the relevant COS. It was felt that responses from 20 trialists would be helpful based on a typical number of participants involved in qualitative research, thus requiring an anticipated 40 trials This rationale has been explained in the methods (2.2.3).

Reviewer comment 6. Similarly, in the section describing data extraction, it might be helpful to signpost to the fact that study 3 will require the contact details of clinical trialist who have been identified in study 2. Otherwise, the reader is left wondering why this information was being extracted from the registry data.

Author response 6. This has been explained in 2.2.4.

Reviewer comment 7. In the data extraction section, it states that ‘data will be retrieved from previous COMET systematic reviews’ but it is not clear how this information will be used in the protocol.

Author response 7. Previous COMET systematic reviews, and ongoing inclusion of published COS by COMET, will be used for details of published COS relevant to this work. Data extraction will include the intended use of recommendations, disease category, disease name, population characteristics (age, sex), interventions, geographical locations of COS developers, geographical locations of COS participants will be extracted, and whether patients participated. This has been explained in 2.1.4.

Reviewer comment 8. We have suggested a few minor wording amendments to improve readability:
Background
Suggest amend to: “There are some benefits to using COS in clinical trials, which include improving the consistency of outcome reporting, increasing the relevance of outcomes measured to decision-makers, and helping to identify potential selective outcome reporting bias.”
Methods
Confusing typo in survey section says ‘A survey will be sent to clinical trialists who will conduct a clinical trial’ – should this be ‘A survey will be sent to clinical trialists who have conducted a clinical trial’?

Author response 8. We have made these changes in the manuscript.

Reviewer comment 9. In the survey, there is a question about whether the respondent is a working in Traditional Chinese Medicine, Integrative Medicine or Western Medicine. Integrative Medicine is not mentioned anywhere in the protocol.

Author response 9. The text has been amended.
Competing Interests: No competing interests were disclosed. Close
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Reviewer Report 30 Nov 2023

Zehuai Wen, Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China

Approved

https://doi.org/10.5256/f1000research.152547.r223685

This is an exciting study with expected results. As far as I know, this may be the first survey in this field in China. The protocol was clearly reported in terms of the rationale, purpose, and procedure of the study.

In addition to the literature review, the study also designed a survey for trial investigators, which is a commendable survey to understand further the current situation of knowledge and application of COS among clinical trial investigators in China, which is also conducive to the development and promotion of COS.

From the structured questions in the survey, it should be possible to analyze why the investigators used or did not use COS, so it is recommended to consider this analysis in the statistical analysis section.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Evidence-based medicine research in traditional medicine; clinical epidemiology; COS development

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

CITE

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Author Response 12 Apr 2024

Ruijin Qiu, University of Liverpool, Liverpool, UK

12 Apr 2024

Author Response

Thank you for your comments and useful feedback. From the structured questions in the survey, trialists who searched COS before registration will be asked about the reason why they did ... Continue reading Thank you for your comments and useful feedback. From the structured questions in the survey, trialists who searched COS before registration will be asked about the reason why they did not use the COS; their responses will be analyzed by content analysis.
Thank you for your comments and useful feedback. From the structured questions in the survey, trialists who searched COS before registration will be asked about the reason why they did not use the COS; their responses will be analyzed by content analysis.
Competing Interests: No competing interests were disclosed. Close
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COMMENTS ON THIS REPORT

Author Response 12 Apr 2024

Ruijin Qiu, University of Liverpool, Liverpool, UK

12 Apr 2024

Author Response

Thank you for your comments and useful feedback. From the structured questions in the survey, trialists who searched COS before registration will be asked about the reason why they did ... Continue reading Thank you for your comments and useful feedback. From the structured questions in the survey, trialists who searched COS before registration will be asked about the reason why they did not use the COS; their responses will be analyzed by content analysis.
Thank you for your comments and useful feedback. From the structured questions in the survey, trialists who searched COS before registration will be asked about the reason why they did not use the COS; their responses will be analyzed by content analysis.
Competing Interests: No competing interests were disclosed. Close
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Version 3

VERSION 3 PUBLISHED 23 Aug 2023

Open Peer Review

Reviewer Status

Reviewer Reports

	Invited Reviewers
	1	2
Version 3 (revision) 17 Jul 24
Version 2 (revision) 28 Mar 24		read
Version 1 23 Aug 23	read	read

Zehuai Wen, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China
Kim Thomas, University of Nottingham, Nottingham, UK

Emma Campbell, University of Nottingham, Nottingham, UK

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Reviewer Report

6 Views

05 Apr 2024 | for Version 2

Kim Thomas, Centre of Evidence Based Dermatology, School of Medicine, University of Nottingham, Nottingham, UK

Emma Campbell, Centre of Evidence Based Dermatology, School of Medicine, University of Nottingham, Nottingham, UK

6 Views Cite this report Responses(0)

Approved

No further comments to make.

Competing Interests

KT is a member of the Executive Group for The Harmonizing Outcome Measures for Eczema and sits on the Methods Committee for the C3 initiative. I confirm that this potential conflict of interest did not affect my ability to write an objective and unbiased review of the article.

Reviewer Expertise

Applied health research, core outcome sets, development and validation of outcome instruments

We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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Reviewer Report

13 Views

28 Feb 2024 | for Version 1

Kim Thomas, Centre of Evidence Based Dermatology, School of Medicine, University of Nottingham, Nottingham, UK

Emma Campbell, Centre of Evidence Based Dermatology, School of Medicine, University of Nottingham, Nottingham, UK

13 Views Cite this report Responses(1)

Approved With Reservations

Determine whether ongoing and completed COS are relevant to the disease burden in China.
Find out whether clinical trialists in China use published COS in their trials.

1. Mapping of burden of disease in China to published COS.
2. Exploring uptake of COS in trials registered on the Chinese clinical trials registry.
3. Mixed methods study to establish awareness, barriers and facilitators to COS uptake (including both an initial survey and subsequent interview study).

Background

Methods

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

KT is a member of the Executive Group for The Harmonizing Outcome Measures for Eczema and sits on the Methods Committee for the C3 initiative.I confirm that this potential conflict of interest did not affect my ability to write an objective and unbiased review of the article.

Reviewer Expertise

Applied health research, core outcome sets, development and validation of outcome instruments

Respond to this report

Responses (1)

Author Response

12 Apr 2024

Ruijin Qiu, University of Liverpool, Liverpool, UK

Reviewer comment 1. This is an ambitious study that will provide an interesting insight into COS uptake in China. It is actually three studies in one:
Mapping of burden of disease in China to published COS.
Exploring uptake of COS in trials registered on the Chinese clinical trials registry.
Mixed methods study to establish awareness, barriers and facilitators to COS uptake (including both an initial survey and subsequent interview study).
It might have been helpful to describe these three aspects separately, with specific aims, objectives and methods for each. Not all of the studies aims and objectives are clearly articulated in the existing two aims.

Author response 1. The three aims were listed in the final paragraph of the Background section, and the methods for each are described in separate subsections of the Methods section.

Reviewer comment 2. The authors suggest that specific COS may be required to evaluate interventions testing Chinese Medicine and that uptake of COS developed in China might be higher than uptake of COS developed internationally. I am a little worried that such a stance goes against the very essence of what COS initiatives are trying to do. Namely to promote a single unified approach to evaluating outcomes in a given condition throughout the world. I am not yet convinced that a COS specific to Chinese Medicine is helpful or required.
Author response 2. We did not intend to suggest that, and have included the rationale for including a COS developed by Chinese researchers in the protocol.

Reviewer comment 3. The approach of focussing on the top 25 diseases by burden of disease in China is interesting and should help to focus the study, although this still represents a lot of work. It is not clear why only COS published since 2012 are included. If a disease category has a gold-standard COS that was published pre-2012 (e.g the work of the OMERACT group), this protocol would count the disease category as having no COS, which seems a shame.
Author response 3. All COS will be analyzed in the mapping of burden of disease in China to COS. A COS published since 2012 would be preferred to one published before 2012 for the analysis of COS uptake if one meets the eligibility criteria. It has been clarified in the methods.

Reviewer comment 4. It is proposed that the COS identified through a search of the COMET database will be evaluated for quality. Whilst this is a laudable ambition, there was very little detail provided as to exactly how this would be done and what the cut-off for meeting the quality standard might be. Rather than excluding COS based on their quality status, I wonder if it would be more useful to include all identified COS, and to report the quality ratings descriptively. At least this information would then be in the public domain and could avoid wasted effort of people repeating these quality assessments.

Author response 4. We have clarified that we will use patient participation in COS development as a marker of methodological quality, with the rationale provided.

Reviewer comment 5. One of the specified inclusion criteria for study 2 (uptake of COS in clinical trials and studies) required that there be “not less than 40 trials for a given condition”. It might be helpful to add an explanation as to why this was included. If trials are only included in cases where at least 40 of them match a specific COS, the authors are not capturing up to 39 trials per disease category.

Author response 5. The online survey will be sent to trialists who registered clinical trials which are relevant to a specific COS. We anticipate a 50% non-response rate, thus if the number of trials is too small, it will be difficult to obtain a reasonable spread of perspectives from trialists about the use of the relevant COS. It was felt that responses from 20 trialists would be helpful based on a typical number of participants involved in qualitative research, thus requiring an anticipated 40 trials This rationale has been explained in the methods (2.2.3).

Reviewer comment 6. Similarly, in the section describing data extraction, it might be helpful to signpost to the fact that study 3 will require the contact details of clinical trialist who have been identified in study 2. Otherwise, the reader is left wondering why this information was being extracted from the registry data.

Author response 6. This has been explained in 2.2.4.

Reviewer comment 7. In the data extraction section, it states that ‘data will be retrieved from previous COMET systematic reviews’ but it is not clear how this information will be used in the protocol.

Author response 7. Previous COMET systematic reviews, and ongoing inclusion of published COS by COMET, will be used for details of published COS relevant to this work. Data extraction will include the intended use of recommendations, disease category, disease name, population characteristics (age, sex), interventions, geographical locations of COS developers, geographical locations of COS participants will be extracted, and whether patients participated. This has been explained in 2.1.4.

Reviewer comment 8. We have suggested a few minor wording amendments to improve readability:
Background
Suggest amend to: “There are some benefits to using COS in clinical trials, which include improving the consistency of outcome reporting, increasing the relevance of outcomes measured to decision-makers, and helping to identify potential selective outcome reporting bias.”
Methods
Confusing typo in survey section says ‘A survey will be sent to clinical trialists who will conduct a clinical trial’ – should this be ‘A survey will be sent to clinical trialists who have conducted a clinical trial’?

Author response 8. We have made these changes in the manuscript.

Reviewer comment 9. In the survey, there is a question about whether the respondent is a working in Traditional Chinese Medicine, Integrative Medicine or Western Medicine. Integrative Medicine is not mentioned anywhere in the protocol.

Author response 9. The text has been amended.

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Competing Interests

No competing interests were disclosed.

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Reviewer Report

21 Views

30 Nov 2023 | for Version 1

Zehuai Wen, Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China

21 Views Cite this report Responses(1)

Approved

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Evidence-based medicine research in traditional medicine; clinical epidemiology; COS development

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

Respond to this report

Responses (1)

Alongside their report, reviewers assign a status to the article:

Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions

[1] 1. The COMET initiative. [Accessed March 26, 2024]. Reference Source

[2] 2. Zhang L, Zhang J, Chen J, et al.: Clinical research of traditional chinese medicine needs to develop its own system of core outcome sets. Evid. Based Complement. Alternat. Med. 2013; 2013: 202703.

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Uptake of core outcome sets by clinical trialists in China: a protocol

Abstract

Background

Methods

Discussion

Trial registration

Keywords

Revised Amendments from Version 2

1.

Background

2.

Methods

Mapping of burden of disease in China to COS

2.1

Table 1. The initial list of diseases for the study (ranked by number of disability-adjusted life-years).

Exploring uptake of COS in trialists in China

2.2

Table 2. The framework for assessing overlap in scope between clinical trials and COS.

Exploring awareness, barriers and facilitators to uptake COS by trialists

2.3

Dissemination

2.4

3.

Discussion

Ethics and consent

Data availability statement

Underlying data

Extended data

Acknowledgments

References

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