Standards of surgical clinical researches: Introduction of IDEAL framework / 中华胃肠外科杂志

ABSTRACT

Many breakthroughs in the field of surgical clinical researches have been achieved in China, but the overall quality is relatively limited, largely because of the insufficiency in standardization, rationality and scientificity of methodology. In consideration of the nature of surgical procedures and equipments, it is necessary to establish a set of methodological system, suitable for the high-quality clinical research in the surgical field. IDEAL collaboration has put forward a systematic methodological framework for innovation in surgical procedure and equipment. For the clinical research on surgical innovation, the IDEAL framework can be divided into five sequential stages, namely, Idea, Development, Exploration, Assessment and Long-term follow-up. In different stages, the difficulties to be faced, the problems to be solved, and the research design to be adopted are diverse and progressive. Although the IDEAL framework is not perfect, it is currently the best framework for surgical clinical research. While performing surgical clinical research, we should continue to think about how to improve the surgical clinical research methodology.