In response to the problems of insufficient available autologous vascular donors for clinical small-diameter artery transplantation and the poor long-term patency rate of artificial vessels, the in-situ tissue-engineered vascular grafts that do not require in vitro cell culture and have low costs have become a research hotspot in the field of cardiovascular repair. However, at present, the evaluation index system for animal experiments in this field is not unified, and the research heterogeneity is large, which makes it difficult to conduct horizontal comparison and integration of results, seriously hindering the clinical transformation of the technology. This study refers to the international COMET initiative and SYRCLE methodological norms, and draws on the construction ideas of the clinical core indicator set. Through literature scope review, platform data search, and expert semi-structured interviews, an initial indicator pool was constructed. After screening candidate indicators through two rounds of Delphi consultation, and centralized discussion and voting by expert consensus meetings, the core outcome indicator set for animal experiments of small-diameter artery in-situ tissue-engineered vascular grafts was finally established. The research results can unify the evaluation standards for animal experiments in this field, effectively reduce publication bias, improve the comparability and standardization of experimental data, and provide evidence-based support for the standardization of basic research on new tissue-engineered vascular grafts and efficient clinical transformation.
ContributorsWanxian Du (principal investigator or supervisors), Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, PR China
Li Tao
1. Department of Cardiology, Gansu Gem Flower Hospital, Lanzhou City, Gansu Province;
2. The Fourth Affiliated Hospital of Gansu University of Traditional Chinese Medicine
Bin Ma
1. Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, PR China;
2. Research Center for Medical Device Regulatory Science, Lanzhou University, Lanzhou, PR China;
3. Industry Center for Evidence-Based Research and Evaluation Standards in Medical Devices, Gansu Province, Lanzhou, PR China
Disease Category: Heart & circulation
Disease Name: Small-caliber artery transplantation
Age Range: Unknown
Sex: Either
Nature of Intervention: Other
- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)
- Methodologists
- Researchers
- COS (Other)
- Consensus conference
- Consensus meeting
- Delphi process
- Semi structured discussion
This study followed the international COMET initiative and SYRCLE methodological guidelines, drew on the construction ideas of the clinical core indicator set, and through literature scope review, platform data search, and semi-structured interviews with experts, constructed the initial indicator pool. After screening candidate indicators through two rounds of Delphi consultation, and through expert consensus meetings for centralized discussion and voting, the core outcome indicator set for the animal experiments of small-diameter arterial in situ tissue-engineered vascular grafts was finally established.