Background
Intracerebral hemorrhage (ICH) is a devastating disease, its mortality and disability rate are high. In China, hypertensive intracerebral hemorrhage (HICH) is responsible for 75% of all the cases of primary ICH. A lot of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) for treating HICH have been carried out. However, these RCTs have a lot of problems, such as heterogeneous outcomes, non-uniform point of measurement. These lead to systematic review/meta-analysis only can include a small number of studies. And outcome measures did not take the wishes of patients and other stakeholders into account. The aim of this study is to establish the core outcome set (COS) for future TCM clinical trials of HICH.
Methods and analysis
First, we will develop a long list of general outcomes by making systematic literature review and semi-structured interviews. Then healthcare professionals and patients with HICH will be invited to participate in two rounds of the Delphi survey to determine the importance of the outcome. Finally, a face-to-face consensus meeting will be conducted to determine the final COS of HICH, including what outcomes should be measured and when and how to measure the outcomes.
Results
We aim to develop a COS that includes TCM core syndrome for HICH to determine what outcomes should be reported and when and how to measure them.
Conclusion
By doing this, we can increase the reporting consistency and reduce the reporting bias in the outcome, which leads to the reuse of research data in meta-analysis and the making of informed healthcare decisions.
Ethics and dissemination
The entire project has received approval from the Ethics Committee of Xiyuan Hospital, China Academy of Chinese Medical Sciences. The final COS will be published and reported at the national and international conferences.
The aim of this study is to establish the core outcome set (COS) for future Traditional Chinese medicine clinical trials of hypertensive intracerebral hemorrhage.
ContributorsMin Jia, Yan Lu, Xiao Liang, Chenguang Tong, Jian Wang, Jun Tang, Jian Yang, Min Wang, Weiwei Jiao, Wanqing Du, Jingjing Wei, Zixiu Zeng, Zhenmin Xu, Qian Chen, Lin Lei, Xing Liao & Yunling Zhang
Disease Category: Neurology
Disease Name: Hypertensive cerebral hemorrhage
Age Range: 18
Sex: Either
Nature of Intervention: Traditional Chinese Medicine
- Clinical experts
- Consumers (patients)
- Methodologists
- Researchers
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Interview
- Systematic review
In phase 1, by making a systematic literature review and semi-structured interviews, we will develop a long list of general outcomes.
In phase 2, we will carry out two rounds of the Delphi survey with different stakeholders.
In phase 3, a face-to-face consensus meeting will be conducted to determine the final COS of HICH, including what outcomes should be measured and when and how to measure the outcomes.