Chronic rhinosinusitis (CRS) is a complex, multifactorial condition widely treated with Traditional Chinese Medicine (TCM), including herbal medicine, acupuncture, and integrative therapies. While significant clinical experience and research evidence have been accumulated in TCM treatment of CRS, the outcome measures used in these studies are often inconsistent, non-standardized, and lack comparability. This variability hinders the ability to conduct systematic reviews and meta-analyses, ultimately affecting the reliability of evidence for TCM interventions.
Considering the existence of a well-developed Core Outcome Set (COS) for chronic rhinosinusitis (Hopkins et al., 2018), which is recommended for all CRS clinical trials regardless of the intervention (https://www.comet-initiative.org/Studies/Details/748), we plan to develop an add-on module specifically tailored for TCM interventions. We will adopt the overarching COS as the default core outcomes and focus on identifying additional TCM-specific core outcomes. The need for this add-on module is based on the following considerations:
1) The existing COS may not fully capture the perspectives of TCM practitioners and patients who receive TCM treatment. The unique aspects of TCM practice, such as syndrome differentiation (????), may require specific outcome measures that reflect changes in tongue coating, pulse type, and other diagnostic indicators that are integral to TCM assessments.
2) TCM treatments often emphasize patient-reported outcomes (PROs) and holistic health effects, which may differ from those captured in the general COS for CRS. These include improvements in symptoms like cough, expectoration, and general well-being, which are important for evaluating the efficacy of herbal and acupuncture interventions.
Our study will follow best practices outlined in the COMET Handbook and COS-STAD guidelines, utilizing a Delphi survey and consensus meetings with TCM experts and patient representatives. This approach aims to develop a robust and comprehensive add-on COS module that addresses the unique needs of TCM interventions in CRS research.
Principal Investigator and affiliations/organisations: Qinxiu Zhang (Director, World Health Organization (WHO) Collaborating Centre, CHN-56, China; Vice Chairman, Allergic Disease, World Federation of Chinese Medicine Societies; Vice Chairman, Doctor Society of integrative Medicine, Chinese Medical Doctor Association; Vice Chairman, Otolaryngology Branch, Chinese Association of Traditional Chinese Medicine; Vice Chairman, Otolaryngology Branch, Chinese Association of Integrative Medicine; Vice Chairman, Sichuan Association of Integrative Medicine; Executive Dean, Integrated Medical School, Chengdu University of Traditional Chinese Medicine, China; Dean, Reproductive & Women-Children Hospital, Chengdu University of Traditional Chinese Medicine, China; Vice Dean, Institute of Integrative Chinese and Western Medicine, 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 and affiliations/organisations: Chai Feng (Second Affiliated Hospital of Henan University of Traditional Chinese Medicine, China); Chen Wenyong (Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, China); Chen Yongna (Sanmenxia Hospital of Traditional Chinese Medicine, China); Cheng Lei (First Affiliated Hospital of Nanjing Medical University, China); Feng Rongchang (Hong Kong Christian Family Service Center Hospital, Hong Kong, China); Gao Jianying (Vancouver Health Hospital of Traditional Chinese Medicine, Canada); Gurdon H. Guyatt (Department of Health Sciences, McMaster University, Canada Cochrane Center, Canada); Hu Kexin (Keelung Hospital, Taiwan Health Department, Taiwan, China); Jiang Luyun (Hospital of Chengdu University of Traditional Chinese Medicine, China); Leng Hui (Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, China); Li Xinrong (Hospital of Chengdu University of Traditional Chinese Medicine, China); Li Yunying (Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, China); Liu Daxin (Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine, China); Liu Jinhui (Nose King Chinese Medicine Clinic, Malaysia); Liu Peng (First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, China); Liu Yuanxian (Shenzhen Hospital of Traditional Chinese Medicine, China); 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 Hui (Hospital of Chengdu University of Traditional Chinese Medicine, China); Xie Qiang (Affiliated Hospital of Jiangxi 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); Yeung Wing Fai (Hong Kong Polytechnic University, Hong Kong, 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: Rhinosinusitis , Sinusitis (chronic rhinosinusitis)
Age Range: 18 - 85
Sex: Either
Nature of Intervention: Traditional Chinese Medicine
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Economists
- Epidemiologists
- Ethicists
- Families
- Governmental agencies
- Journal editors
- Methodologists
- Patient/ support group representatives
- Policy makers
- Researchers
- Statisticians
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Literature review
- Nominal group technique (NGT)
- Semi structured discussion
- Survey
- Systematic review
The development of the add-on Core Outcome Set (COS) for Traditional Chinese Medicine (TCM) interventions in chronic rhinosinusitis (CRS) will be conducted using a comprehensive, mixed-method approach. This approach integrates systematic evidence synthesis, expert consensus techniques, and direct stakeholder involvement to ensure the robustness and relevance of the resulting outcomes. The specific methods employed in this study include:
1) Systematic Review and Literature Analysis:
A comprehensive systematic review of existing literature will be conducted to identify relevant outcome measures used in TCM-based CRS studies. The review will cover databases such as PubMed, Embase, CNKI, and Cochrane Library, including both English and Chinese publications. The findings from the literature review will help form the preliminary list of potential core outcomes specific to TCM interventions.
2) Delphi Process:
The Delphi process will be utilized to gather expert opinions and build consensus on potential TCM-specific core outcomes. A panel of TCM practitioners, otolaryngologists, researchers, and patient representatives will be selected based on their expertise and experience. Multiple rounds of Delphi surveys will be conducted, with each round refining the list of outcomes based on feedback and achieving consensus through structured rating and prioritization.
3) Interviews:
Semi-structured interviews will be conducted with key stakeholders, including TCM practitioners and patients with CRS. These interviews aim to capture the unique perspectives of those directly involved in TCM treatments and to identify any additional outcomes that may not have been identified in the literature review. Interviews will be transcribed and analyzed thematically to supplement the preliminary outcome list.
4) Nominal Group Technique (NGT):
The Nominal Group Technique (NGT) will be employed in facilitated consensus meetings to prioritize and rank the identified outcomes. This method involves small group discussions where participants independently rank the outcomes, followed by group deliberation and re-ranking to achieve a consensus on the most important core outcomes specific to TCM interventions.
5) Survey:
A broader survey will be conducted with a larger group of TCM practitioners and patients to validate the preliminary core outcomes identified in the earlier stages. The survey will be designed to assess the relevance and importance of each outcome, ensuring that they reflect real-world clinical practice and patient experiences.
6) Semi-Structured Discussions and Consensus Meetings:
In addition to the Delphi process and NGT, semi-structured discussions and consensus meetings will be held with a diverse panel of stakeholders, including TCM experts, otolaryngologists, and patient representatives. These meetings will provide an opportunity for in-depth discussion of the proposed outcomes, addressing any disagreements and refining the final core outcome set.
7) Finalization and Reporting:
The final core outcome set will be determined based on the combined results of the Delphi process, interviews, NGT sessions, and surveys. The outcomes will be categorized into patient-reported outcomes (PROs), clinical outcomes, and TCM-specific diagnostic indicators. The finalized COS will be reported following the COS-STAD and COS-STAR guidelines to ensure transparency, reproducibility, and scientific rigor.