Background: Acute pancreatitis (AP) is one of the most common gastrointestinal diseases. Traditional Chinese medicine (TCM) in combination of western medicine has been widely used in the treatment of AP. Due to the heterogeneity and selective reporting of outcomes in clinical trials, similar studies cannot be merged and compared, diminishing the value of clinical trials in assessing the effectiveness and safety. Herein, we designed a core outcome set (COS) on Traditional Chinese Medicine and Western Medicine for AP.
Methods/design: This study will be conducted in four stages led by a multidisciplinary Steering Committee. (1)A preliminary list of outcomes was constructed through a systematic review of previously published researches and patients’ semi-structured interviews. (2)TCM syndromes of AP will be constructed from the results of a systematic review and a prospective cohort study. (3)An expert questionnaire will be developed from a preliminary list of outcomes and TCM syndrome. Two rounds of the Delphi surveys on different stakeholders were conducted to select candidate items for a consensus meeting. (4)A final COS for AP will be developed at a consensus meeting involving in the different stakeholders.
Yuxin Shen and Lihui Deng are the principal investigators.
Yuxin Shen, Lihui Deng, Zhiyao Chen, Chen Hu, Ziqi Lin, Ping Zhu, Qingyuan Tan,Qing Xia
West China Centre of Excellence for Pancreatitis, Institute of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University
Ling Li, Xin Sun
Chinese Evidence-based Medicine Centre, Cochrane China Centre and MAGIC China Centre, West China Hospital, Sichuan University
Disease Category: Gastroenterology
Disease Name: Acute Pancreatitis
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Traditional Chinese Medicine
- Clinical experts
- Conference participants
- Consumers (patients)
- Journal editors
- Methodologists
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Systematic review
A preliminary list of outcomes was constructed through a systematic review of previously published researches and patients’ semi-structured interviews. TCM syndromes of AP will be constructed from the results of a systematic review and a prospective cohort study. An expert questionnaire will be developed from a preliminary list of outcomes and TCM syndrome. Two rounds of the Delphi surveys on different stakeholders were conducted to select candidate items for a consensus meeting. A final COS for AP will be developed at a consensus meeting involving in the different stakeholders.