Developing patient-reported core outcome sets for 10 predominant diseases of heat-sensitive moxibustion in community study

Background
Heat-sensitive moxibustion is a complementary and alternative therapy in traditional Chinese medicine. In China, heat-sensitive moxibustion has been used in the management of multiple chronic diseases, especially for self-administration in community. However, there is still lack of high-quality evidence for such setting. A main reason is that there are no patient-reported core outcome sets for heat-sensitive moxibustion study in community setting, which leads to overabundant outcomes and inconsistent measurements and time points in the current clinical research of heat-sensitive moxibustion. This study aims to develop patient-reported core outcome sets for 10 predominant diseases of heat-sensitive moxibustion in community study, including knee osteoarthritides, cervical spondylosis, lumbar disc herniation, dysmenorrhea, allergic rhinitis, periarthritis, rheumatoid arthritis, asthma, insomnia and hypertension.

Methods
This study will include three steps: (1) we will first establish an outcome pool by performing a systematic review of 10 predominant diseases of heat-sensitive moxibustion and semi-structured interview with patients, and then develop questionnaires for outcome lists of all diseases for the Delphi survey. (2) We will conduct 2-3 rounds of Delphi survey using the above questionnaires to assess whether the outcomes are important and appropriate for patient-reported in community setting. (3) Finally, we will hold a consensus meeting to form the formal core outcome sets.

Discussion
The findings of this study will minimize the risk of reporting inappropriate outcomes, improve the quality of evidence, and save resources for the community studies of heat-sensitive moxibustion. The core outcome sets developed by this study will also add contents to the database of core outcomes of traditional Chinese medicine.

Contributors

Xu Zhou, Shuqing Li, Yanping Wang, Qingni Wu, Sijie Chen, Minchao Deng, and Ahua Li

Further Study Information

Current Stage: Ongoing
Date: September 2020 - 2020
Funding source(s): the National Natural Science Foundation of China (No. 81904057)


Health Area

Disease Category: Other

Disease Name: Allergic rhinitis, Asthma , Dysmenorrhea, Hypertension, Insomnia , Osteoarthritis, Rheumatoid arthritis, cervical spondylosis, Lumbar disc herniation, Periarthritis

Target Population

Age Range: 0 - 120

Sex: Either

Nature of Intervention: Complementary and alternative medicine (CAM) therapy, Traditional Chinese Medicine

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Epidemiologists
- Methodologists
- Researchers
- Statisticians

Study Type

- COS Patient Reported Outcomes
- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Consensus meeting
- Delphi process
- Semi structured discussion
- Systematic review

This study will include three steps: (1) we will first establish an outcome pool by performing a systematic review of 10 predominant diseases of heat-sensitive moxibustion and semi-structured interview with patients, and then develop questionnaires for outcome lists of all diseases for the Delphi survey. (2) We will conduct 2-3 rounds of Delphi survey using the above questionnaires to assess whether the outcomes are important and appropriate for patient-reported in community setting. In the first round, the experts will rate each outcome and complement missed outcomes. In the second round, the experts will receive the results of the first round and make further judgements. If the second round cannot reach consensus for all outcomes, we will run the third round of Delphi survey. (3) Finally, we will hold a consensus meeting to form the formal core outcome sets.

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