Construction of Core Outcome Set for Diabetic Foot in Traditional Chinese Medicine Clinical Researches

Diabetic foot is one of the most common and serious chronic complications of diabetes. An estimated show that one amputation of a diabetic limb occurs every 20 seconds worldwide; The annual mortality rate of patients with diabetic foot ulcer is as high as 11%, while the mortality rate of amputees is as high as 22%. Domestic and foreign studies have shown that the cost of diabetic foot is huge, accounting for about one-third of the total medical expenses of diabetes. Several studies have shown that Chinese medicine in the treatment of diabetic foot may have good curative effect, but the lack of a unified traditional Chinese medicine treatment of diabetic foot clinical research at the core outcome of the index, therefore, the purpose of this study is setting a a core outcome of clinical study of traditional Chinese medicine treatment of diabetic foot, laying a foundation for better conducting clinical research.

Contributors

Dai Xinyue, Zi Mingjie, Liu Chunxiang, Sun Mingyue, Wang Yiming, Gao Rui

Publication

Journal: Journal of Traditional Chinese Medicine
Volume: 64
Issue: 9
Pages: -
Year: 2023
DOI:

Further Study Information

Current Stage: Completed
Date: December 2019 - December 2020
Funding source(s): National Key R&D Program of China


Health Area

Disease Category: Endocrine & metabolic

Disease Name: Diabetic foot ulcer/ulceration

Target Population

Age Range: 18 - 80

Sex: Either

Nature of Intervention: Traditional Chinese Medicine

Stakeholders Involved

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

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Consensus meeting
- Delphi process
- Interview
- Systematic review

Long list of outcomes will be identified from 3 sources. Firstly a systematic review of the literature. Secondly patient interviews and thirdly from an Retrospective study.
A 2-3 round Delphi survey will then be undertaken to condense the long list of outcomes and the final core outcome set will be decided by a consensus meeting of the steering committee.