Four years of teaching principles in clinical trials--a continuous evaluation of the postgraduate workshop for surgical investigators at the study center of the German Surgical Society.

INTRODUCTION

Only a small part of the daily work in the field of surgery is based on high-level evidence. To improve the rate of evidence-based medicine (EBM) in surgery, more surgical, randomized controlled trials have been advocated. In addition, it has been recognized that educational issues that concern methods and techniques of clinical research are of similar importance. Therefore, a clinical investigator course focusing particularly on the issues of surgical trials was initiated in 2005. The structure of this course is demonstrated here as well as the results of its evaluation over the last 4 years.

MATERIAL AND METHODS

All participants were invited to rate both the lecture and the teachers with the help of a standardized evaluation questionnaires (rating scale from 1 = excellent to 6 = insufficient). Lectures were evaluated via questions on content, comprehension, and learning effect. Teachers were evaluated in terms of rhetorical abilities, content, and presentation technique, respectively. Assessment of personal long-term learning effects was evaluated by an e-mail survey.

RESULTS

Seventy-three participants were trained in a total of 4 courses. Participants in each course completed the evaluation questionnaires. In 2005, 20 of 21 (95.2%) participants completed the questionnaire; in 2006, 11 of 11 participants completed it (100%); in 2007, 19 of 22 (86.4%) participants completed it; and in 2008, 16 of 19 (84.2%) participants completed it. The overall evaluation of the course was graded 1.52 for content and 1.72 for clarity, and the learning effect was assessed at 1.60. The 16 lecturers came from different institutions involved in clinical research and evidence-based surgery. Besides classic lecturing, the current assembly of the course consists of 6 lectures designed as hands-on sessions. A survey (48.5% response rate) with a mean follow-up of 1.72 years (range, 6 months to 3 years) revealed that the enduring learning effect was rated 2.09, and 70.4% of former participants actually participated in randomized controlled trials.

CONCLUSIONS

The development of a clinical investigator course tailored to the needs of surgeons provides hospitals with a key tool for promoting surgical interest in clinical trials.