Quality of reporting and adherence to the ARRIVE guidelines 2.0 for preclinical degradable metal research in animal models of bone defect and fracture:a systematic review

In vivo testing is crucial for the evaluation of orthopedic implant efficacy and safety.However,the translation and reproducibility of preclinical animal experiments are not always satisfactory,and reporting quality is among the essential factors that ensure appropriate delivery of information.In this study,we assessed the reporting quality of in vivo investigations that examined the use of degradable metal materials in fracture or bone defect repair.We employed scientific databases,such as PubMed,EMBASE,Web of Science,Cochrane Library,CNKI,WanFang,VIP and Sinomed to screen for in vivo investigations on fracture or bone defect repair using degradable metal materials,and extracted both epidemiological and main characteristics of eligible studies,and assessed their reporting quality using the ARRIVE guidelines 2.0.Overall,263 publications were selected,including 275 animal experiments.The overall coincidence rate of Essential 10(22 sub-items)and Recommended Set(16 sub-items)were 42.0%and 41.5%,respectively.Based on our analysis,the reporting quality of the published in vivo investigations examining fracture/bone defect repair with degradable metal materials was low,and there was a lack of transparent,accurate and comprehensive reporting on key elements of the experimental design and other elements that are meant to avoid bias.

Evidence-based biomaterials research

The fast development of biomaterials science and engineering has generated significant number of studies and publications as well as tremendous amount of research data.A methodology is needed to translate such research data and results to validated scientific evidence.This article for the first time proposes the concept and methodology of evidence-based biomaterials research,which is to use evidence-based research approach represented by systematic reviews to generate evidence for answering scientific questions related to biomaterials.After briefly introducing the advancement of biomaterials since 1950s,the scientific and engineering nature of biomaterials are discussed along with the roadmap of biomaterials translation from basic research to commercialized medical products,and the needs of scientific evidence.Key information of the evidence-based approach such as its origination from evidence-based medicine,levels of evidence,systematic review and meta-analysis,differences between systematic and narrative reviews is then highlighted.Applications with a step-by-step procedure of conducting evidence-based biomaterials research,three examples of biomaterials research using evidence-based approach to generate scientific evidence,and opportunities and challenges of evidence-based biomaterials research are presented.With its notable impact on the practice of medicine,the evidence-based approach is also expected to make influential contributions to the biomaterials field.