Protocol for the development of a core outcome set for cervical spondylosis of vertebral artery type, including time for measuring the outcomes: the CSA-COS study

Introduction: Findings of clinical trials can be compromised by the wide heterogeneity of the outcomes reported. Moreover, the outcomes that matter most to patients might not be reported. Developing and applying a ‘core outcome set’ (COS) can solve these problems. A core outcome set represents a minimum set of outcomes that should be reported in any clinical trial in a specific health condition. This study aims to develop a core outcome set for cervical spondylosis of vertebral artery type, including time for measuring the outcomes (the CSA-COS study).

Methods and analysis: The CSA-COS study will propose three phases. Phase one: A systematic review of the literature and semi-structured interviews with 30 patients will be conducted to form the initial list of outcomes for the Delphi survey. Phase two: A 2-round Delphi will be conducted to prioritize these outcomes, from the perspective of patients, clinicians, methodologist of evidence-based medicine, and journal editor who assess the importance of each outcome. Phase three: We will hold a final consensus meeting, and will invite international stakeholders to reassess the preliminary CSA-COSs and to finalize the final CSA-COSs including time for measuring the outcomes.

Ethics and dissemination: Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine has approved of this study (DZMEC-KY-2020-32). The final COS will be available freely.

Contributors

Jinyu Li ab,Guiyu Feng c,Ruijin Qiu a,Wei Wang c,Xu Wei d,He Yin d,Dong Yu e,Hengping Liu e,Jian Huang c,Yusong Jia b,Hongcai Shang a

a Key Laboratory of Chinese Intemal Medicine of the Ministry of Education, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, 100700, PR China
b District 1 of Orthopedics, Dongzhimen Hospital, Beijing University of Chinese Medicine,100700, PR Chin
c Beijing University of Chinese Medicine,100029, PR China
d Spine 2 Department, Wang Jing Hospital of China Academy of Chinese Medical Sciences, 100102, PR China
e Spine Surgery, Beijing University of Chinese Medicine Third Affiliated Hospital,100029, PR China

Further Study Information

Current Stage: Ongoing
Date: July 2020 - June 2022
Funding source(s): This work was supported by the National Natural Science Foundation of China (81503601), the Young Talents Training, Program of Dongzhimen Hospital of the Beijing University of Chinese Medicine (DZMYS-201802), the Basic Scientific Research Service Fee project of the Beijing University of Chinese Medicine (2020-JYB-ZDGG-111),Young Talent Lifting Project of China Association of Traditional Chinese Medicine(NQRC2-C08).


Health Area

Disease Category: Other

Disease Name: cervical spondylosis

Target Population

Age Range: 18 - 65

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Journal editors
- Methodologists

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Consensus meeting
- Delphi process
- Semi structured discussion
- Systematic review

The CSA-COS study will propose three phases. Phase one: A systematic review of the literature and semi-structured interviews with 30 patients will be conducted to form the initial list of outcomes for the Delphi survey. Phase two: A 2-round Delphi will be conducted to prioritize these outcomes, from the perspective of patients, clinicians, methodologist of evidence-based medicine, and journal editor who assess the importance of each outcome. Phase three: We will hold a final consensus meeting, and will invite international stakeholders to reassess the preliminary CSA-COSs and to finalize the final CSA-COSs including time for measuring the outcomes.

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