Colorectal adenoma is the most important precancerous lesion of colorectal cancer, and its clinical management is critical for reducing the incidence of colorectal cancer. Integrated Traditional Chinese and Western medicine has shown unique advantages in the prevention and treatment of colorectal adenoma, becoming a research hotspot. However, current clinical trials exhibit considerable heterogeneity in the selection of efficacy outcome measures, with issues such as complex and numerous indicators, vague definitions, and inconsistent standards. The lack of a recognized core outcome set (COS) makes it difficult to integrate and compare research findings, limiting the generation of high-quality evidence. A search of the COMET database identified one relevant COS on full-thickness intra-laparoscopic excision of colonic polyps, which focuses on surgical technical outcomes and does not cover the comprehensive management or the characteristics of integrated Traditional Chinese and Western medicine. This study aims to develop a COS for the prevention and treatment of colorectal adenoma with integrated Traditional Chinese and Western medicine, covering the full course from prevention, screening, diagnosis, treatment to rehabilitation, to provide a unified evaluation framework and promote evidence-based research in this field.
ContributorsThe principal investigator:
Jie Liu,Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
Long Ge,Department of Health Policy and Management, School of Public Health, Lanzhou University, Lanzhou, China
Haibo Cheng,The First Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing , China
Other contributors:
Wenjing Liu,Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
Ning Ma,Department of Health Policy and Management, School of Public Health, Lanzhou University, Lanzhou, China
Weilong Zhao,Department of Health Policy and Management, School of Public Health, Lanzhou University, Lanzhou, China
Disease Category: Gastroenterology
Disease Name: Colorectal adenoma
Age Range: 0 - 100
Sex: Either
Nature of Intervention: Complementary and alternative medicine (CAM) therapy, Drug, Surgery, Traditional Chinese Medicine
- Clinical experts
- Conference participants
- Researchers
- Statisticians
- COS for practice
- Consensus conference
- Delphi process
- Interview
- Literature review
This study systematically searched Chinese and English databases, including the China National Knowledge Infrastructure (CNKI), Wanfang Data, Chongqing VIP Chinese Science and Technology Periodical Database (VIP), China Biomedical Literature Service System (SinoMed), PubMed, Embase, the Cochrane Library, and Web of Science, as well as clinical trial registration centers. Relevant domestic and international literature on integrated traditional Chinese and Western medicine for the treatment of colorectal adenoma was comprehensively collected. Basic characteristics of the included studies, together with all involved clinical evaluation indicators and outcome measures, were extracted. Meanwhile, relevant clinical guidelines and expert consensus statements were systematically reviewed, and face-to-face expert interviews were integrated. After standardized sorting, an initial pool of outcome indicators was established.
On the basis of the indicator pool, the research team designed an electronic questionnaire for the first round of the Delphi survey. Experts in related fields were invited to rate the importance of each indicator through on-site distribution, email, or online platforms. The working group summarized and analyzed the results of the first round, added new indicators according to expert suggestions, and formulated a second Delphi questionnaire for another round of expert rating. According to the scores obtained in the second round, the working group ranked all indicators by clinical importance and preliminarily screened candidate indicators for the consensus meeting.
Finally, an expert consensus meeting was held. Attending experts rated each candidate indicator one by one and conducted full discussions. Through collective discussion and voting, a core outcome set for integrated traditional Chinese and Western medicine in the treatment of colorectal adenoma was ultimately developed.