Protocol of the CONSORT and SPIRIT Extension for multicenter clinical trials

Xuan Zhang, Chongya Dong, Nana Wang, Chun Pong Chan, Chung Tai Lau, Juan Wang, Jiangxia Miao, Chen Yao, Youping Li, Aiping Lu, David Moher*, Zhaoxiang Bian*

*Corresponding author for this work

Research output: Contribution to journalJournal articlepeer-review

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.
Original languageEnglish
Article number1241152
Number of pages6
JournalFrontiers in Public Health
Volume11
DOIs
Publication statusPublished - 15 Sept 2023

Scopus Subject Areas

  • Public Health, Environmental and Occupational Health

User-Defined Keywords

  • CONSORT checklist
  • SPIRIT checklist
  • center heterogeneity
  • multicenter clinical trial
  • reporting guideline

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