Benign breast nodules are common and frequently-occurring diseases among women, with a huge number of patients. Ablation, as a minimally invasive surgery, is increasingly favored by patients with benign breast nodules due to its short operation time, small trauma, and no obvious postoperative scar formation. However, there are problems such as breast pain, long nodule absorption time after ablation, and nodule recurrence after ablation. Traditional Chinese medicine (TCM) has been found to have good therapeutic effects in improving the mood of patients after ablation of benign breast nodules, alleviating breast pain, promoting the dissipation of nodules and reducing nodule regeneration. There are currently published studies on the application of TCM after ablation of breast nodules, but there is no unified clinical efficacy evaluation standard. The selection of efficacy evaluation indicators has problems such as randomness, unstandardization, unimportance and lack of recognition. Therefore, it is necessary to establish a core outcome set for clinical trials of TCM in the treatment of benign breast nodules after ablation.
ContributorsWeishuai Wang(Principal Investigator). Pizhou Hospital of Traditional Chinese Medicine, Xuzhou, China
Hucheng Wang. Pizhou Hospital of Traditional Chinese Medicine, Xuzhou, China
Xinyao Jin. Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin
Wei Feng. Pizhou Hospital of Traditional Chinese Medicine, Xuzhou, China
Yao Lou. Pizhou Hospital of Traditional Chinese Medicine, Xuzhou, China
Gazi Zhou. Pizhou Hospital of Traditional Chinese Medicine, Xuzhou, China
Disease Category: Other
Disease Name: Benign Breast Nodules
Age Range: 18 - 60
Sex: Female
Nature of Intervention: Traditional Chinese Medicine
- Clinical experts
- Consumers (patients)
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Semi structured discussion
- Systematic review
A systematic review will be conducted to identify currently reported outcomes in clinical trials. Semi-structured interviews of patients will be conducted to fill gaps in potential outcomes. Then, two rounds of Delphi surveys and a consensus meeting will be conducted to develop a COS.