Objective To construct the core outcome set (COS) for clinical research on Uyghur medicine in treating psoriasis by using internationally-recognized research methods, thus to aid the researchers in choosing the standardized outcomes and to enhance the quality of evidence from research findings.
Methods A systematic retrieval of Chinese and English databases was conducted to collect outcomes from clinical studies, systematic reviews, and registered protocols of Uyghur medicine for treating psoriasis. An outcome pool was constructed based on the results of literature review. The outcomes were supplemented after qualitative surveys of patients and physicians, and then an initial list of outcomes was formed. Two rounds of Delphi surveys on the initial list were conducted for obtaining Likert scale ratings from different stakeholder groups to evaluate the importance of outcomes. After that,a consensus meeting was held to finalize the COS for clinical research on Uyghur medicine in treating psoriasis.
Results The COS for clinical research on Uyghur medicine in treating psoriasis comprises six domains, totaling 14 outcomes. The 14 outcomes were psoriasis symptoms (psoriasis area and area severity index, skin manifestations (erythema, scaling, infiltration, etc.), investigator global assessment, patient global assessment, treatment satisfaction, health-related quality of life, recurrence rate, adverse events, drug adverse reactions, blood routine, urine routine, liver and kidney function, Uyghur medicine symptom assessmen, and fluid changes.
Conclusion The COS for clinical research on Uyghur medicine in treating psoriasis has been constructe, and will provide a reference for the selection of efficacy-evaluation outcomes and for the reporting of outcomes in related studies.
YU Ruifang(1), JULAITI Abuduwaiti(2), LIU Shaonan(1,3), CHEN Genghang (1,3), HUANG Qian(1,3), ZAITUGULI Wufuer(2), TURSON Upur(2), LI Zhijian(2), GUO Xinfeng(1,3)
1. The Second Clinical Medical School, Guangzhou University of Chinese Medicine, Guangzhou 510405 Guangdong, China
2. Uygur Medicine Hospital of Xinjiang Uygur Autonomous Region, Urumqi 830049 Xinjiang, China
3. The Second Affiliated Hospital of Guangzhou University of Chinese Medicine/Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120 Guangdong, China
Disease Category: Skin
Disease Name: Psoriasis
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Complementary and alternative medicine (CAM) therapy, Drug
- Clinical experts
- Methodologists
- Patient/ support group representatives
- Researchers
- Statisticians
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Literature review
- Survey
Literature review supplemented through qualitative surveys with patients and Uyghur dermatologists, resulting in an initial set of outcomes. Two rounds of a Delphi survey were conducted based on the list, obtaining Likert scores from various stakeholders on the importance of each outcome. The final inclusion of outcomes in COS was determined through a consensus meeting.