Background: Diabetic Foot (DF) is one of the most common complications of diabetes, and it is characterized by high morbidity, disability, lethality and low cure rate. Traditional Chinese medicine treatment has certain characteristics and advantages in diabetic foot. Due to selective reporting bias and heterogeneity of research results, on the one hand, relevant clinical studies are of low quality and poor practicability, and on the other hand, similar studies cannot be included in meta-analysis to form high-quality evidence-based evidence and evaluate the value of studies. Therefore, the development of a core set of outcomes (COS-TCM-DF) for traditional Chinese medicine for the treatment of diabetic foot is an important way to address these issues.
Methods: The COS-TCM-DF project will refer to the developed COS methodology and the steps are divided into four stages: (1) a scoping review and analysis of enrolled research protocols to collect and analyze all existing outcomes that have been used in trials on the prevention or treatment of diabetic foot with Chinese Medicine; (2) qualitative interviews with Diabetic foot patient and attendants to Collect additional outcomes related to them; (3) Gather opinion est and obtain initial consensus from key stakeholders, including patients, clinicians, researchers, and pharmaceutical company staff, through a Delphi survey; (4) a consensus meeting was held to develop the final COS-TCM-DF.
Discussion: Currently, there is no COS on measuring or monitoring diabetic foot with TCM in trials or clinical practice. The COS-TCM-DF will be developed to advance the synthesis of evidence regarding the prevention and treatment of diabetic foot in TCM and to promote the standardized and consistent application of results in future studies in this field.
Trial registration: Registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, December 2019 https://www.comet-initiative.org/Studies/Details/1553.
The purpose of this paper is to propose a protocol for the development of COS for a trial of Chinese medicine for the prevention or treatment of diabetic foot (COS-TCM-DF).
ContributorsXin Yue Dai, Ming Jie Zi, Chun Xiang Liu, Yi Ming Wang, Rui Gao
Disease Category: Endocrine & metabolic
Disease Name: Diabetic foot ulcer/ulceration
Age Range: Unknown
Sex: Either
Nature of Intervention: Traditional Chinese Medicine
- COS for clinical trials or clinical research
- COS for practice