Core outcomes in clinical safety evaluation for cardiovascular disease in traditional Chinese medicine and western medicine

There are some problems in clinical safety assessment of clinical trials for traditional Chinese medicine (TCM). First, it is difficult to determine TCM’s clinical safety when it is combined with western medicine. Second, the patient-reported adverse events/effects reporting is insufficient. Third, clinical safety outcome reporting is diverse in similar clinical trials. These problems lead to some clinical trials cannot provide sufficient evidence to clinical practice. Based on the previous research experience in developing core outcome set for beneficial outcomes evaluation, this project proposes to develop the preferred method for the doctor-patient co-operated necessary outcomes in clinical safety evaluation of integrated traditional Chinese medicine and western medicine. Based on the known adverse effects of western medicine, it will help researchers assess if TCM has the effect of attenuating or increasing adverse events/effects when Chinese medicine is combined with western medicine. Doctor-patient co-operated core outcome set for safety assessment will improve the reliability of symptomatic adverse events/effects reporting. The core outcome set and its measurement instrument for clinical safety evaluation will decrease the heterogeneity of safety outcomes reporting, so that more clinical trials may be included in systematic reviews to provide evidence for clinical practice. This project takes cardiovascular disease as an example to explore the method of developing doctor-patient co-operated necessary outcomes for safety evaluation.


Ruijin Qiu and Hongcai Shang are the principal investigators.

Further Study Information

Current Stage: Completed – pending publication
Date: January 2020 - 2022
Funding source(s): National Natural Science Foundation (81904051)

Health Area

Disease Category: Heart & circulation

Disease Name: Cardiovascular Disease

Target Population

Age Range: 18 - 80

Sex: Either

Nature of Intervention: Drug, Traditional Chinese Medicine

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Methodologists
- Pharmaceutical industry representatives
- Researchers

Study Type

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


- Consensus meeting
- Delphi process
- Interview
- Systematic review

The research methods of developing doctor-reported core outcome set for safety evaluation and the patient-reported core symptom set for adverse events/effects and their measurement instruments include systematic review, semi-structured interview, Delphi survey, consensus meeting and so on. Semi-structured interview and cross-sectional survey will be conducted thereafter to assess the validity and reliability of measurement instruments. This project may bring new ideas for safety evaluation of integrated traditional Chinese and western medicine’s clinical trials.

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