Objective: This study aimed to establish a COS for urticaria treatment in clinical trials.
Methods: According to the COMET handbook, we will first conduct a systematic review of the clinical research on urticaria to extract outcome indicators and construct a questionnaire. Next, we will organize a group of clinicians, nurses, patients, researchers, etc, to conduct in-depth interviews, and determine the core indicator set of urticaria through two rounds of anonymous Delphi questionnaire surveys and two rounds of consensus meetings.
Summarizing: This study hopes to provide clear guidance on which results should be measured in clinical trials for patients with urticaria,and hopes to help improve the health and well-being of these patients.
Jianhong Li and Ruijin Qiu are the principal investigators.
Contributors: Jiacheng Gao.
Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine.
Disease Category: Skin
Disease Name: Urticaria
Age Range: 18 - 65
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Conference participants
- Consumers (patients)
- Epidemiologists
- Ethicists
- Methodologists
- Patient/ support group representatives
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus conference
- Delphi process
- Literature review
- Survey
- Systematic review
According to the COMET handbook, we will first conduct a systematic review of the clinical research on urticaria to extract outcome indicators and construct a questionnaire. Next, we will organize a group of clinicians, nurses, patients, researchers, etc, to conduct in-depth interviews, and determine the core indicator set of urticaria through two rounds of anonymous Delphi questionnaire surveys and two rounds of consensus meetings.