Background
Traditional Chinese medicine therapy has obvious advantages in the treatment of interstitial lung disease with pulmonary fibrosis. However, there are still inconsistent outcomes reported. This has led to a lack of reproducibility and scientific validity of clinical studies, difficulties in cross-sectional comparison of efficacy of different regimens, and inability to combine results from studies in the same field. The aim of this study is to develop a core outcome set for clinical trials of traditional Chinese medicine on interstitial lung disease with pulmonary fibrosis.
Methods
This study will construct a clinical efficacy evaluation index system for fibrosing interstitial lung disease with traditional Chinese medicine characteristics through the following steps: (1) Constructing an outcome pool: First, we will establish the outcome pool by performing systematic review of fibrosis interstitial lung disease and semi-structured interviews with patients. (2) Delphi expert consultation: A questionnaire will be developed based on the outcome pool, and then 2 rounds of Delphi surveys will be conducted to assess the importance of these outcome indicators. (3) Consensus meeting: A consensus meeting will be held to reach consensus on the Delphi findings and to establish a formal core outcome set.
Discussion
In this study, the core outcome set of clinical trials of traditional Chinese medicine for fibrotic interstitial lung disease will be reported according to the COS-STARCOS specification. The aim is to provide a reference for clinical research on the treatment of fibrotic interstitial lung disease with traditional Chinese medicine.
Relevant COS
We are aware of a study, Co-designing a Core Outcome Set for and with patients with Idiopathic Pulmonary Fibrosis, which is ongoing. The target disease for this study is IPF, but the disease we are focusing on includes not only IPF, but also pulmonary fibrosis due to interstitial lung disease. The highlight of our study is the focus on TCM indicators of interest to patients.
To develop a core outcome set for clinical trials of traditional Chinese medicine on interstitial lung disease with pulmonary fibrosis.
ContributorsLei Xu, Shaofeng Li, Shiwen Ke, Lisha Mo and Mingliang Qiu will screen articles, extract data, assess risk of bias, and perform data analysis. Shuqing Li designed the study and conducted the search. Liangji Liu provided critical methodological advice.
Disease Category: Lungs & airways
Disease Name: Interstitial Lung Diseases
Age Range: 18
Sex: Either
Nature of Intervention: Traditional Chinese Medicine
- Clinical experts
- Consumers (patients)
- Epidemiologists
- Methodologists
- Researchers
- Statisticians
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Literature review
- Semi structured discussion
- Systematic review
(1) Constructing an outcome pool: First, we will establish the outcome pool by performing systematic review of fibrosis interstitial lung disease and semi-structured interviews with patients. (2) Delphi expert consultation: A questionnaire will be developed based on the outcome pool, and then 2 rounds of Delphi surveys will be conducted to assess the importance of these outcome indicators. (3) Consensus meeting: A consensus meeting will be held to reach consensus on the Delphi findings and to establish a formal core outcome set.