Developing a Core Outcome Set for Vitiligo in Uyghur medicine clinical trials

Background: Uyghur medicine is an important part of Chinese ethnic medicine, and it has a long history of treating vitiligo. Several clinical trials have explored the efficacy of Uyghur medicine in the treatment of vitiligo, however, these studies had problems with unreasonable selection of outcome measures. While consensus on vitiligo COS has been reached in 2015, some Uyghur-specific symptoms or signs, like the temperature and moisture of skin, the color of sclera, tongue and pulse situation, did not be fully expressed in the current COS for vitiligo. Therefore, it is necessary to develop a Uyghur-specific COS for vitiligo.

Aim

Objective: This study is to develop a COS specially for Uyghur medicine based on the current vitiligo core outcome domains, that is, to add on a Uyghur-specific module to the existing COS for vitiligo.

Contributors

The principal investigator is Qian Huang, and the supervisors are Shao-nan Liu and Xin-feng Guo. They all come from the Guangdong Provincial Hospital of Chinese Medicine.

Further Study Information

Current Stage: Completed – pending publication
Date: April 2023 - 2024
Funding source(s): National Key R&D Program of China (No. 2022YFC3501001)


Health Area

Disease Category: Skin

Disease Name: Vitiligo

Target Population

Age Range: 18 - 80

Sex: Either

Nature of Intervention: Complementary and alternative medicine (CAM) therapy

Stakeholders Involved

- Clinical experts
- Methodologists
- Patient/ support group representatives

Study Type

- COS for clinical trials or clinical research

Method(s)

- Delphi process
- Literature review
- Survey

A literature review on Uyghur medicine clinical trials as well as a survey involving vitiligo patients and Uyghur practitioners will be conducted to collect Uyghur-specific symptoms or signs. Then we will carry out a two-round Delphi process to achieve an agreement on the Uyghur-specific outcomes, which will be an add-on module to the existing COS for vitiligo.