Evidence map›Paper›PMID 36224599›Full record

ArticleTrials2022

Development of a core outcome set for hypertensive intracerebral hemorrhage in clinical trials of traditional Chinese medicine: a study protocol.

Min Jia, Yan Lu, Xiao Liang, Chenguang Tong, Jian Wang, Jun Tang, Jian Yang, Min Wang, Weiwei Jiao, Wanqing Du and 7 more

Abstract read
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–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

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. 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

17 authors.

Min JiaXiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Yan LuXiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Xiao LiangXiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Chenguang TongXiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Jian WangThe Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, China.
Jun TangChongqing Traditional Chinese Medicine Hospital, Chongqing, China.
Jian YangChongqing Traditional Chinese Medicine Hospital, Chongqing, China.
Min WangGraduate School, Beijing University of Chinese Medicine, Beijing, China.
Weiwei JiaoXiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Wanqing DuGraduate School, Beijing University of Chinese Medicine, Beijing, China.
Jingjing WeiXiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Zixiu ZengGraduate School, Beijing University of Chinese Medicine, Beijing, China.
Zhenmin XuXiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Qian ChenGraduate School, Beijing University of Chinese Medicine, Beijing, China.
Lin LeiGraduate School, Beijing University of Chinese Medicine, Beijing, China.
Xing LiaoCenter for Evidence-based Chinese Medicine, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China. okfrom2008@hotmail.com.
Yunling ZhangXiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China. yunlingzhang2004@126.com.

Funding

Fundamental Research Funds for the Central Universities 1 million RMBFundamental Research Funds for the Central Universities three hundred thousand RMB
6 · The paper itself

Abstract

backgroundIntracerebral 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.

resultsWe 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.

conclusionBy 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.

trial registrationThis study is registered with the Core Outcome Measures in Effectiveness Trials database as study 1475 . Registered on December 2019.

Indexed as

Intracranial Hemorrhage, HypertensiveMedicine, Chinese TraditionalDelphi TechniqueHumansMeta-Analysis as TopicOutcome Assessment, Health CareResearch DesignSystematic Reviews as TopicTreatment OutcomeClinical trialsCore outcome setHypertensive intracerebral hemorrhageProtocolTraditional Chinese medicine

Identifiers

PMID36224599
PMCPMC9559838

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Registered trials

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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.