Evidence map›Paper›PMID 37780430›Full record

ArticleFrontiers in public health2023

Protocol of the CONSORT and SPIRIT Extension for multicenter clinical trials.

Xuan Zhang, Chongya Dong, Nana Wang, Chunpong Chan, Chung Tai Lau, Juan Wang, Jiangxia Miao, Chen Yao, Youping Li, Aiping Lyu and 2 more

Abstract read
In one paragraph

Article in Frontiers in public health, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Xuan ZhangChinese Clinical Trial Registry (Hong Kong), Hong Kong Chinese Medicine Clinical Study Centre, Chinese EQUATOR Centre, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, Hong Kong SAR, China.
Chongya DongMedical Statistics Office, Peking University First Hospital, Beijing, China.
Nana WangChinese Clinical Trial Registry (Hong Kong), Hong Kong Chinese Medicine Clinical Study Centre, Chinese EQUATOR Centre, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, Hong Kong SAR, China.
Chunpong ChanDepartment of Computer Science, Faculty of Science, Hong Kong Baptist University, Hong Kong, Hong Kong SAR, China.
Chung Tai LauChinese Clinical Trial Registry (Hong Kong), Hong Kong Chinese Medicine Clinical Study Centre, Chinese EQUATOR Centre, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, Hong Kong SAR, China.
Juan WangChinese Clinical Trial Registry (Hong Kong), Hong Kong Chinese Medicine Clinical Study Centre, Chinese EQUATOR Centre, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, Hong Kong SAR, China.
Jiangxia MiaoSchool of Chinese Medicine, The Chinese University of Hong Kong, Hong Kong, Hong Kong SAR, China.
Chen YaoMedical Statistics Office, Peking University First Hospital, Beijing, China.
Youping LiChinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, China.
Aiping LyuChinese Clinical Trial Registry (Hong Kong), Hong Kong Chinese Medicine Clinical Study Centre, Chinese EQUATOR Centre, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, Hong Kong SAR, China.
David MoherClinical Epidemiology Program, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada.
Zhaoxiang BianChinese Clinical Trial Registry (Hong Kong), Hong Kong Chinese Medicine Clinical Study Centre, Chinese EQUATOR Centre, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, Hong Kong SAR, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Multicenter clinical trials play an indispensable role for assessing the efficacy of a new intervention or treatment, particularly in Phase II or III studies. Previous studies have shown that these studies often suffer from inadequate reporting of key details related to their design, implementation, and analysis, both in the protocol and final reports. This limitation reduces the practical and scientific value of the findings. Furthermore, the lack of guidance on how to report multicenter features can contribute to poor reporting. Therefore, this study aims to develop guidelines to improve the reporting of multicenter trials, including two Extensions of the CONSORT 2010 and the SPIRIT 2013. Methods/design: The standard methodology for developing health research reporting guidelines involves the following steps: (i) Identifying the need for development and launching the research project; (ii) Preparing the registration and reviewing the literatures; (iii) Proposing the initial Checklists and conducting the Delphi exercise; (iv) Arranging the consensus meeting and formulating the Checklists; (v) Conducting the pilot test and drafting explanatory documents (E&E); (vi) Seeking comments from advisory group and finalizing the guidelines; and (vii) Developing the publication and dissemination strategies. Conclusion: By using the CONSORT and SPIRIT checklists as starting points, the development of extensions specific to multicenter trials can help researchers design and report high-quality clinical research. This, in turn, can facilitate the application of study findings in the current evidence-based healthcare system.

Indexed as

ChecklistClinical Trials as TopicResearch DesignConsensusHumansMulticenter Studies as Topiccenter heterogeneityCONSORT checklistmulticenter clinical trialreporting guidelineSPIRIT checklist

Identifiers

PMID37780430
PMCPMC10540686

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.