Gastroesophageal reflux disease (GERD) is a disorder characterized by the reflux of gastric and duodenal contents into the esophagus due to impaired anti-reflux barriers and defective esophageal clearance, resulting in increased esophageal acid exposure and/or esophagitis. Based on endoscopic findings, GERD can be classified into three categories: non-erosive reflux disease (NERD), reflux esophagitis (RE), and Barrett's esophagus (BE). GERD presents with heartburn and regurgitation as cardinal symptoms and may be accompanied by extra-esophageal manifestations, significantly impairing patients' quality of life. In recent years, integrated Traditional Chinese and Western Medicine has increasingly demonstrated advantages in managing GERD, offering multi-target, multi-dimensional therapeutic effects with favorable cost-effectiveness. However, current clinical research in this field is hampered by substantial heterogeneity in outcome measure selection and a lack of syndrome-specific outcome instruments. To enhance the standardization and comparability of clinical research, this study aims to develop a core outcome set (COS) for evaluating the clinical efficacy of integrated Traditional Chinese and Western Medicine treatment of GERD.
This study will be conducted using established COMET methodology and will include:
1. A systematic literature review of Chinese and English databases (including CNKI, WanFang Data, SinoMed, PubMed, EMBASE, and the Cochrane Library) and clinical trial registries to identify and classify outcomes reported in existing studies on integrated Traditional Chinese and Western Medicine treatment of GERD.
2. Supplementary surveys, including clinician questionnaires, patient questionnaires, and cross-sectional investigations, to address gaps in the published literature and inform the development of an outcome pool.
3. A two-round Delphi survey to prioritise outcomes and determine candidate items for the core outcome set, followed by a consensus meeting incorporating the Nominal Group Technique (NGT) to establish the final COS and corresponding core outcome measures for integrated Traditional Chinese and Western Medicine management of GERD.
Principal investigator:
Tingying Tang, Zhengkun Hou
Other contrinutors:
Wenjie Xu, Jing tian, Shaofen Xu
Disease Category: Gastroenterology
Disease Name: Gastro-oesophageal reflux disease (GERD)
Age Range: 18 - 80
Sex: Either
Nature of Intervention: Any, Traditional Chinese Medicine
- Clinical experts
- Consumers (patients)
- Journal editors
- Methodologists
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Literature review
- Nominal group technique (NGT)
- Survey
- Systematic review
This COS is intended for application in GERD patients aged 18–80 years receiving integrated Traditional Chinese and Western Medicine intervention and will serve for efficacy evaluation in relevant clinical trials. The research will be conducted in five phases:
1. Systematic literature review: A comprehensive literature search will be performed across Chinese and English databases to identify and classify outcomes reported in existing studies.
2. Semi-structured interviews: Semi-structured interviews with patients will be conducted to identify outcomes of greatest concern to patients.
3. Supplementary surveys: Clinician questionnaires, patient questionnaires, and cross-sectional investigations will be conducted to address gaps in the published literature and enrich the outcome pool.
4. Delphi survey: A two-round Delphi survey will be conducted to screen outcomes and achieve preliminary consensus among stakeholders.
5. Consensus meeting & NGT: A final consensus meeting, incorporating the Nominal Group Technique (NGT), will be held with representative stakeholders to discuss the survey results and reach final agreement on the core set of outcomes that must be measured and reported in all future clinical trials.