Pay special attentions to the essentials in conducting surgical trials

Abstract

Conducting clinical trials is a distinguishing responsibility for surgeons, which could provide high quality evidence to guidelines for clinical practice and healthcare policy. However, implementation of clinical researches or trials is the weakness for general surgeons for quite some time. Finding scientific problems, determining study type, selecting rational endpoints, calculating sample size, defining proper observation index, strictly control of the research process and correctly evaluating the final sets are important steps for investigators. Surgical operations are typical interventions in clinical practice, and are ideal ways for investigations to build evidence-based safety and efficacy. It is difficult to obtain high-level evidence by retrospective studies, because of its insufficient data, confounding factors and selection bias. Prospective studies could overcome these shortages although they consume a relative long time and cost a lot. Prospective big data registration, cohort study and multicenter randomized controlled study are becoming a trend in surgical researches. According to the IDEAL framework, carrying pilot study, critical quality-control, carefully carry-out process and assessment are essential steps for a surgical innovation and to improve its subsequent reliability. Changing the surgeons' traditional thinking mode, transforming clinical behavior patterns, and combining the clinical practice and researches are helpful to improve their occupational behavior and comprehensive abilities.