Colorectal cancer liver metastases (CRLM) is one of the most common and life-threatening complications of colorectal cancer, with approximately 50% of patients developing liver metastases during the course of their disease. Despite advancements in surgical resection and systemic chemotherapy, the long-term prognosis remains challenging for many patients due to high recurrence rates and treatment-related toxicities. Traditional Chinese Medicine (TCM) has been increasingly integrated into the multidisciplinary management of CRLM, showing potential in enhancing quality of life, reducing side effects of chemotherapy, and prolonging survival.As a result, the number of TCM-related clinical trials for CRLM has been rising annually. However, heterogeneous reporting of outcomes in these trials lacks consistency and transparency, which significantly hinders the ability to compare effectiveness across various studies during meta-analysis synthesis. Furthermore, there is a substantial risk of selective outcome reporting bias, as many trials fail to report patient-centered or long-term clinical endpoints. Therefore, it is both necessary and urgent to establish a core outcome set (COS) for TCM in clinical trials of CRLM. This COS will provide a standardized set of outcomes that should be measured and reported in all future trials, ensuring the relevance, reliability, and comparability of TCM research in this field.
ContributorsPrincipal investigator:
Shulan Hao, Shanxi Academy of Traditional Chinese Medicine, Taiyuan, China
Other contributors:
Nan Li and Dongdan Xu,Shanxi Academy of Traditional Chinese Medicine, Taiyuan, China
Baoxin Dong, Chenyang Bai, Hanying Zhang and Ziming Guo , Shanxi University of Traditional Chinese Medicine, Taiyuan, China
Disease Category: Cancer
Disease Name: Colorectal Liver Metastases
Age Range: 18 - 80
Sex: Either
Nature of Intervention: Traditional Chinese Medicine
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Journal editors
- Methodologists
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Literature review
- Nominal group technique (NGT)
The development of this COS will be conducted in four integrated stages:
Literature Review & Item Generation: A comprehensive literature review will be performed to identify all potential outcomes previously reported in clinical trials of TCM for CRLM.
Qualitative Interviews: Semi-structured interviews will be conducted with patients and caregivers to identify patient-reported outcomes (PROs) and ensure the inclusion of perspectives that matter most to those living with the disease.
Delphi Process: A two-round international Delphi survey will be administered. Stakeholders, including TCM oncologists, hepatobiliary surgeons, methodologists, and patients, will score the importance of each candidate outcome using a 9-point Likert scale.
Consensus Meeting & NGT: A final consensus meeting, incorporating the Nominal Group Technique (NGT), will be held with representative stakeholders to discuss the survey results and achieve a final agreement on the core set of outcomes that must be measured and reported in all future clinical trials.