Core Outcome Measures in Effectiveness Trials

A core outcome set for clinical trials of Chinese Medicine in hyperlipidemia

General Information

Summary:
Hyperlipidemia is the main composition of dyslipidemia, while dyslipidemia is a primary, major risk factor for atherosclerotic cardiovascular disease (ASCVD) and may even be a prerequisite for ASCVD, occurring before other major risk factors come into play. The morbidity of dyslipidemia is about 40.40% in China , and cardiovascular disease events caused by total cholesterol (TG) are to increase 9.2 million from 2010 to 2030 .According to 2009 to 2012 data, more than 100 million US adults =20 years of age have total cholesterol levels =200 mg/dL; almost 31 million have levels =240 mg/dL. An estimated 15.5 million Americans =20 years of age have Coronary Heart Disease (CHD), total CHD prevalence is 6.2%, 7.6% for men and 5.0% for women . Cardiovascular disease (CVD) kills more than 4 million deaths each year across Europe, accounting for 45% of all deaths, and it kills more women [2.2 million (49%)] than men [1.8 million (40%)].
More than 2000 plants are used in traditional herbal or alternative medical systems and some may provide relief to patients with cardiovascular diseases, especially those with hyperlipidemia. Some studies find that Chinese Medicine may be effective for treating hyperlipidemia, but this finding has to be interpreted with caution due to the many existing methodological defects of Traditional Chinese Medicine (TCM) trials. Outcome measure is one of the key factors . For example, a systematic review of 35 trials investigating the efficacy of Zhibituo (a Chinese patent medicine) for hyperlipidemia reported a total of 30 different outcomes, and none of these outcomes focus on the ASCVD events. Problems concerning the outcome measure on hyperlipidemia are mainly showed as follows: (1) outcome measures varied from one trial to another and this heterogeneity results in difficulties with synthesizing data from individual studies, as well as resulting in studies being prone to reporting bias and a lack of patient relevance ; (2) there was no agreed and standardized TCM-related outcome; (3) Surrogate endpoints, such as biochemical indicators, were widely adopted. Due to these problems, the practical value of clinical researches was limited.
A core outcome set (COS) is a group of outcome measures that have been identified by key stakeholder groups as the most important in determining the success of treatment of a particular condition.This initiative aims to develop a COS for hyperlipidemia in clinical trials of TCM.

Contributors:
Zehuai Wen is the principal investigator, Xiankun Chen, Geng Li, Li Zhou, Wenwei Ouyang, Meiling Xuan, Liming Lu, Xiaoyan Li, Xiaohui Guo

Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China

Further Study Information

Current Stage:
Ongoing
Date:
February 2017 - December 2018
Funding source(s):
The Specific Research Fund for TCM Science and Technology of Guangdong Provincial Hospital of Chinese Medicine

Health Area

Disease Category
Endocrine & metabolic

Disease Name
Hyperlipidemia

Target Population

Age Range
18 - 75

Sex
Either


Nature / type of Intervention
Drug
Traditional Chinese Medicine

Method(s)

Consensus meeting
Delphi process
Systematic review

There will be five key stages to development of the COS: (1) Systematic review to identify currently reported outcomes in clinical trials of CM in hyperlipidemia. (2) Development of a panel of experts (3) Three-round Delphi survey to gain expert opinions (4) Consensus meeting to finalize the items and definitions (5) Promotion and update.


Stakeholders Involved

Clinical experts
Consumers (patients)
Ethicists
Journal editors
Methodologists
Patient/ support group representatives
Policy makers
Regulatory agency representatives
Researchers
Statisticians

Study Type

COS for clinical trials or clinical research

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