The Core Outcome Set for Adult’s Allergic Rhinitis with the Acupuncture and Moxibustion (COSAARAM) in Clinical Trials

Adult’s allergic rhinitis is one of the most common allergic diseases. At present, adult’s allergic rhinitis is one of the most serious chronic diseases, which similar to allergic asthma, allergic enteritis and chronic urticaria. As an ancient medical therapy, acupuncture and moxibustion has increasingly attracted the public interest on its unique advantages in treating the main symptoms including nasal congestion, nasal itching, rhinorrhea and sneeze on adult’s allergic rhinitis. However, there are insufficient evidences with high quality for clinical study in China, especially lack of the objective evaluation indexes and standardized outcome indicators. It is necessary to develop the Core Outcome Set for Adult’s Allergic Rhinitis with the Acupuncture and Moxibustion (COSAARAM) in clinical trials, improving the consistency of clinical outcome reporting and objective evaluation of effectiveness.

Contributors

Contributors:
Master. Yunfeng Jiang1, Dr. Jun Xiong1, Master. Xiaohong Zhou1, Bachelor. Lingling Xu1, Master. Kai Liao1, Master. Haiping Zhou2 , Bachelor. Liubai Lan3 and Bachelor. Qiuchao Zeng4

1. The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Nanchang Jiangxi, 330006; 2. Taizhou Central Hospital,Taizhou Zhejiang,318000;3.Guangxi University of Traditional Chinese Medicine, Nanning Guangxi,530001;4.Wuming District Hospital of traditional Chinese Medicine, Nanning Guangxi, 530100;

Master. Yunfeng Jiang is the principal investigator.

Further Study Information

Current Stage: Ongoing
Date: September 2019 - September 2021
Funding source(s): Project of the National Natural Science Foundation of China (81573835), Jiangxi Outstanding Young Talents Funding Scheme, China (20171BCB23093), Jiangxi Young Jinggang Scholars Award Program, China (GanJiao DengZi [2018] no. 82), Jiangxi Provincial Youth Science Fund Key Project (20192ACB21007)


Health Area

Disease Category: Ear, nose, & throat

Disease Name: Allergic rhinitis

Target Population

Age Range: 18 - 65

Sex: Either

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

Stakeholders Involved

- Clinical experts
- Conference participants
- Epidemiologists
- Methodologists
- Patient/ support group representatives
- Researchers
- Statisticians

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

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

Firstly, the systematic review was conducted by searching and reviewing all potentially outcomes for the acupuncture and moxibustion therapy on adult's allergic rhinitis in the mainstream clinical databases. Simultaneously, the semi-structured interviews were established to gain the aspect of what the most patients care about. Secondly, all preliminary items in the COSAARAM was confirmed by Steering Committee through the way of the expression standardization, the similar items combination and the original list categorization. Then, the score method of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) was followed to design the option of the questionnaire and the group of the important grading items of the COSAARAM about experts and patients was acquired by the two-round Delphi survey. The Analytic Hierarchy Process (AHP) was performed to weigh and assess the comprehension of experts and patients about the importance of COSAARAM. Finally, the expert panel meeting will be conducted with 20 experts invited. All members will vote and decide the final recommended COSAARAM from potential core outcomes. The semi-structured interview will be performed again and a clinical trial will be made to validate the COSAARAM.

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