Background: Development of a core outcome set (COS) for clinical trials for COVID-19 is urgent because of the pandemic wreaking havoc worldwide and the heterogeneity of outcomes in clinical trials.
Methods: A preliminary list of outcomes was developed after a systematic review of protocols of clinical trials for COVID-19. Then, two rounds of the Delphi survey were conducted. Stakeholders were traditional Chinese medicine (TCM) experts, Western medicine (WM) experts, nurses, and the public. Patients with confirmed COVID-19 were also invited to participate in a questionnaire written in understandable language. Then different stakeholders participated in a consensus meeting by video conference to vote.
Results: Ninety-seven eligible study protocols were identified from 160 clinical trials. Seventy-six outcomes were identified from TCM clinical trials and 126 outcomes were identified from WM clinical trials. Finally, 145 outcomes were included in the first round of the Delphi survey. Then, a COS for clinical trials of TCM and WM was developed. The COS included clinical outcomes (recovery/improvement/progression/death), etiology (SARSCoV-2 nucleic-acid tests, viral load), inflammatory factor (C-reactive protein), vital signs (temperature, respiration), blood and lymphatic-system parameters (lymphocytes, virus antibody), respiratory outcomes (pulmonary imaging, blood oxygen saturation, PaO2/ FiO2 ratio, arterial blood gas analysis, mechanical ventilation, oxygen intake, pneumonia severity index), clinical efficacy (prevalence of preventing patients with mild-to-moderate disease progressing to severe disease), and symptoms (clinical symptom score). Outcomes were recommended according to different types of disease. Outcome measurement instruments/definitions were also recommended.
Conclusion: Though there are some limitations for the research, such as insufficient patients and the public involvement, and the unbalanced stakeholders' region, the COS for COVID-19 may improve consistency of outcome reporting in clinical trials. It also should be updated with research progression.
Ruijin Qiu1, Chen Zhao2, Tengxiao Liang3, Xuezeng Hao4, Ya Huang1, Xiaoyu Zhang1,
Zhao Chen1, Xuxu Wei1, Mengzhu Zhao5, Changming Zhong1, Jiayuan Hu1, Min Li 6,
Songjie Han1, Tianmai He1, Yang Sun1, Jing Chen7 and Hongcai Shang1*
1 Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of
Chinese Medicine, Beijing, China, 2 Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical
Sciences, Beijing, China, 3 Emergency Department, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing,
China, 4 Cardiology Department, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China, 5 Cardiology
Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China, 6 Cardiology
Department, Beijing University of Chinese Medicine Third Affiliated Hospital, Beijing, China, 7 Cardiology Department,
Baokang Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China
Disease Category: Infectious disease
Disease Name: Novel coronavirus pneumonia, Coronavirus
Age Range: 1 - 80
Nature of Intervention: Drug, Traditional Chinese Medicine
- Clinical experts
- Consumers (patients)
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Literature review
- Systematic review
A preliminary list of outcomes were developed after a systematic review of protocols of clinical trials for COVID-19. Then two rounds of Delphi survey was conducted. The stakeholders included traditional Chinese medicine (TCM) experts, Western medicine experts, nurses and the public. Patients with confirmed COVID-19 were also invited to participate in a questionnaire with simple language. Frontline clinicians (including TCM and Western medicine clinicians), nurse, methodologist, evidence-based medicine researcher and staff from Chinese Clinical Trials Registry participate in video conference to vote.