Core Outcome Set for Adenomyosis in Traditional Chinese Medicine (COS-AM-TCM)

At present, the outcomes of clinical trials are generally inconsistent and non-standard, making it difficult to compare and combine similar trials. Therefore, it is necessary to establish a core outcome set for clinical trials of traditional Chinese medicine for the treatment of adenomyosis.

Contributors

Contributors: Weiwei Sun (the principal investigator), Xing Liao, Ruihua Zhao (supervisors)

Affiliations: China Academy of Chinese Medical Sciences Guang’anmen Hospital, Institute Of Basic Research In Clinical Medicine, China Academy Of Chinese Medical Sciences

Further Study Information

Current Stage: Ongoing
Date: April 2022 - December 2023
Funding source(s): No funding source


Health Area

Disease Category: Gynaecology

Disease Name: Adenomyosis

Target Population

Age Range: 18 - 45

Sex: Female

Nature of Intervention: Traditional Chinese Medicine

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Methodologists
- Patient/ support group representatives
- Researchers

Study Type

- COS for clinical trials or clinical research

Method(s)

- Consensus conference
- Delphi process
- Systematic review

A preliminary list of outcome was obtained by systematically reviewing the existing randomized controlled studies of traditional Chinese medicine in the treatment of adenomyosis. The Chinese and English databases were retrieved, and the data were extracted by two researchers at the same time. The extracted content included the author's name, publication time, intervention measures, and outcomes. Included clinical trial data formed the primary outcome list.

Two rounds of the Delphi survey were conducted, and the list of outcome measures was sent to experts for importance and recommendations according to the Likert scoring system.

At the consensus meeting, the scoring results of each outcome of the second round of the Delphi survey were displayed. For the outcome indicators that did not reach a consensus, participants could continue to score or vote until a consensus was reached, forming a set of TCM core outcome set.

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