Allergic rhinitis (AR) is a type I (immediate) allergic disease of nasal mucosa. This is a non-infectious inflammatory disease of nasal mucosa, which is mainly released by IgE-mediated mediators (mainly histamine) and involves a variety of immune active cells and cytokines, after the allergic individuals contact with allergens. Typical manifestations of AR are paroxysmal nasal itching, frequent sneezing, a large amount of clear water like mucus, and nasal congestion. Most clinical studies on the treatment of AR with traditional Chinese medicine have confirmed the clinical efficacy of traditional Chinese medicine and acupuncture intervention methods, but there are many problems in the clinical study of AR with traditional Chinese medicine, such as inconsistent outcome indicators, measurement tools, efficacy standards, etc. This hinders the combination and comparison of research results in systematic review or meta-analysis, and leads to low medical evidence. In addition, the comprehensive core output sets (COS) of traditional Chinese medicine of AR has not been established. Therefore, the establishment of corresponding COS can help solve the above problems to a certain extent. The purpose of this study is to build a COS that reflects the characteristics of traditional Chinese medicine in AR treatment, provide scientific reference for the selection of outcome indicators of follow-up clinical research, and improve the quality of clinical research.
ContributorsPrincipal investigator with affiliations/Organisations: Prof. Qinxiu Zhang M.D. [Director, World Health Organization (WHO) Collaborating Centre, CHN-56, China; Vice Chairman, Doctor Society of integrative Medicine, Chinese Medical Doctor Association; Vice Chairman, Otolaryngology Branch, Chinese Association of Integrative Medicine; Vice Chairman, Sichuan Association of Integrative Medicine; Dean, Reproductive & Women-Children Hospital, Chengdu University of Traditional Chinese Medicine, China; Dean, Second Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, China; Academic Leader, Hospital of Chengdu University of Traditional Chinese Medicine, China; Deputy Editor, Chinese Journal of Otorhinolaryngology In Integrative Medicine; Deputy Editor, Chinese Journal of Ophthalmology and Otorhinolaryngology; Editorial Board Member, Journal of Tropical Medicine].
Contributors with affiliations/Organisations: Chai Feng (Second Affiliated Hospital of Henan University of Traditional Chinese Medicine, China); Cheng Lei (First Affiliated Hospital of Nanjing Medical University, China); Chen Wenyong (Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, China); Chen Yongna (Sanmenxia Hospital of Traditional Chinese Medicine, China); Gao Jianying (Vancouver Health Hospital of Traditional Chinese Medicine, Canada); Feng Rongchang (Hong Kong Christian Family Service Center Hospital, China Hong Kong); Hu Kexin (Keelung Hospital, Taiwan Health Department, China Taiwan); Jiang Luyun (Hospital of Chengdu University of Traditional Chinese Medicine, China); Leng Hui (Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, China); Li Yunying (Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, China); Li Xinrong (Hospital of Chengdu University of Traditional Chinese Medicine, China); Liu Peng (First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, China); Liu Daxin (Oriental Hospital, Beijing University of Traditional Chinese Medicine, China); Liu Yuanxian (Shenzhen Hospital of Traditional Chinese Medicine, China); Liu Jinhui (Malaysia Nose King Chinese Medicine Clinic, Malaysia); Ruan Yan (First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, China); Tong Xuanfu (NPO Japan-China Health Association, Japan); Wang Deyun (National University of Singapore, Singapore); Wang Junge (Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, China); Xie Qiang (Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, China); Xie Hui (Hospital of Chengdu University of Traditional Chinese Medicine, China); Xiong Dajing (Hospital of Chengdu University of Traditional Chinese Medicine, China); Yan Zhanfeng (Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine, China); Yang Shasha (First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, China); Zhang Zhicheng (Second Affiliated Hospital of Henan University of Traditional Chinese Medicine, China); Zhao Jiping (Dongzhimen Hospital (Beijing University of Traditional Chinese Medicine, China); Zhao Yu (West China Hospital, Sichuan University, China); Zhou Li (Hospital of Chengdu University of Traditional Chinese Medicine, China).
Disease Category: Ear, nose, & throat
Disease Name: Allergic rhinitis
Age Range: 6 - 75
Sex: Either
Nature of Intervention: Traditional Chinese Medicine
- Clinical experts
- Conference participants
- Consumers (patients)
- COS for clinical trials or clinical research
- COS for practice
- Consensus conference
- Consensus meeting
- Delphi process
- Interview
- Literature review
- Semi structured discussion
- Survey
- Systematic review
1. Research method and design
Establish guidance group experts, including TCM clinical experts, evidence-based methodology experts, clinical researchers, policy makers and COS researchers, to give comments and guidance at each key stage of the study. The working group is responsible for the specific work of this core indicator set research, and regularly organizes meetings to communicate and promote the topic. If there are differences, they can be resolved through seminars or advisory steering committee expert groups.
Based on the literature review survey, the search of clinical trial registration database, and the questionnaire survey of clinicians and patients, the index pool of clinical trials for the treatment of allergic rhinitis with violets was generated. Based on the indicator pool, the working group held a group meeting to preliminarily screen the indicators in the indicator pool according to the six principles of combination of disease and syndrome, clinical importance, standardization/recognition, specificity, stability and feasibility, as well as the accumulated clinical practice experience, during which all members can add any items they think are important to supplement. By voting, 90% of the members considered it unnecessary to enter the initial list of indicator pool entries, and the remaining entries were approved by the Steering Committee to enter the initial list of indicator entries.
2. Delphi survey
The Delphi process consists of two rounds of electronic questionnaire survey, analysis and feedback. The first round of survey includes two items: scoring each indicator in the list of primary indicators; Collect important items that may be omitted from the preliminary list. The second round of survey provides feedback from the first round and collects the participants' further scores. Among them, the new indicator entries confirmed in the first round are fed back to the second round for scoring.
The questionnaire is developed and released through the online survey platform. The content of the first round of questionnaire is based on the initial indicator entry list, and the content of the second round of questionnaire is based on the feedback results of the first round of survey.
Send an email summarizing the study to all participants (except the patient representative group) with a link to the questionnaire, and ask them to complete the first round of Delphi survey within 2 weeks. Send a reminder email after the first week to urge the completion of the survey. With the support of outpatient doctors, the investigators of the working group conducted a face-to-face survey in the patient waiting area and completed the first round of Delphi survey paper questionnaire.
Participants are required to score each indicator item according to the importance of the indicator. The score is 1-9 points and "uncertain", in which 1-3 points are unimportant, 4-6 points are important but not critical, and 7-9 points are key. If participants cannot determine the importance of an item, they can choose "Not sure" when scoring
The working group confirms whether the indicator added by the participants is duplicate with the indicator in the list to determine whether it is a new indicator. For each item, count the number of participants and the distribution of scores. According to the "importance" of the indicators, the indicators with importance = 70% shall be retained, and the remaining indicators shall be discussed by the working group, and controversial indicators can be retained. All reserved indicator entries will enter the second round of survey.
3. Definition of consensus
If an outcome indicator item is supported by at least 70% of the "key" score (7~9 points), and it is believed that consensus is reached, the indicator will be recommended first.
4. Consensus meeting
The main goal of the consensus meeting is to determine the items of the core indicator set and the selection of participants in the consensus meeting. In addition to the members of the steering committee and the working group, outstanding representatives of stakeholder groups and senior experts in other relevant fields who have completed the two rounds of Delphi survey are also invited to participate. Considering the convenience of participants, the venue of the meeting was chosen to be held in Tianjin. The final details will be prepared by the working group according to the Delphi survey, and the project leader will preside over the relevant meetings.
The consensus meeting process has five parts: first, a brief research review; The second is to summarize and display the scoring results of each outcome indicator by each stakeholder organization, introduce each item in the list of candidate core indicators and the number of stakeholder groups that have reached consensus; The third is that participants vote anonymously for the candidate core indicators; The fourth is to discuss the voting results and reach a consensus to establish the core index set for the treatment of allergic rhinitis with traditional Chinese medicine. All participants have the right to discuss any item. If there is any difference, it can be resolved through the nominal group method. Fifth, collect suggestions for later revision and promotion.
5. Statistics
The distribution of index scores in the first round of Delphi survey is the percentage of different gradient scores ("unimportant", "important but not critical" and "critical") in various interest groups. The first round of response rate is the percentage of the number of people who have completed this round of survey in the total number of patients who have received email invitations and received questionnaires. The "importance" ranking of indicators, i.e. the percentage of participants who score = 4 points.
The score distribution of Delphi round 2 is the same as that of round 1. Loss of visit bias was assessed by comparing the number of people who completed the two rounds of survey with the number who only completed the first round of survey. The number of people who score 7 to 9 points in the index in the stakeholder group accounts for = 70% of the total number of people in the respective group, which means that the consensus of the group is obtained. If the percentage of people who score 7 to 9 in n interest groups is = 70%, then n is the number of consensus groups.
The consensus process is the same as the Delphi survey method. If more than 70% of the participants in the consensus meeting vote for a key indicator to be included in the core indicator set, the consensus is reached.