Dysphagia is a common disorder after stroke, affecting half of the acute stroke sufferers. It is associated with respiratory complications, increasing the risk of aspiration pneumonia, nutritional compromise, and dehydration. Studies show that Traditional Chinese Medicine (TCM), including acupuncture, moxibustion, tuina, and herbal medicine, has the potential effect on the rehabilitation of swallowing function. However, TCM is still rarely, or at very low levels, recommended for the treatment of dysphagia. The low recommendation level is partly related to inconsistent results and outcome measurement instruments in previous study results. A variety of evaluation methods have been used in previous studies, such as the Water Swallowing Test (WST), Videofluoroscopic swallowing study (VFSS), Fiberoptic Endoscopic Evaluation of Swallowing (FEES), Functional Oral Intake Scale (FOIS), and whether to remove the nasal feeding tube. Due to heterogeneity caused by multiple evaluation results, it is difficult to evaluate TCM’s efficacy properly. Therefore, developing the core outcome and outcome measurement instruments set of TCM for dysphagia is essential.
ContributorsXiaonong Fan[1,2,3,4] (principal investigator), Yuzheng Du[1,2], Shu Wang [1,5], Li Li[1,4], and Jian Liu[1,3]
Institutions:
1. First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Acupuncture Department, Tianjin, China;
2. National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, China;
3. Tianjin Key Laboratory of Acupuncture and Moxibustion, Tianjin, China;
4. Laboratory of Dosage-Effect Relationship, National Administration of Traditional Chinese Medicine (Level 3), Tianjin, China;
5. Key Laboratory of Cerebropathy Acupuncture Therapy of State Administration of Traditional Chinese Medicine, Tianjin, China.
Disease Category: Rehabilitation
Disease Name: Dysphagia
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Traditional Chinese Medicine
- Clinical experts
- Patient/ support group representatives
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Systematic review
There will be four main parts of this study, including literature review, interview(s), delphi process, and consensus meeting, in order to (1) characterize the selection and definition of outcomes used in existing trials of Traditional Chinese Medicine in dysphagia; (2) obtain consensus on a core outcome set for future trials of Traditional Chinese Medicine in dysphagia.