Use of a Formative Feedback Tool in Place of an Expert Coach in Laparoscopic Suturing Training: A Randomised Non-inferiority Trial

Amani G Munshi, MD1, Yusuke Watanabe, MD1, Katherine McKendy, MD1, Yoichi M Ito, PhD2, Gerald M Fried, MD, FRCSC, FACS1, Melina C Vassiliou, MD, MEd, FRCSC1, Liane S Feldman, MD, FRCSC, FACS1. 1McGill University Health Center, 2Department of Biostatistics, Hokkaido University Graduate School of Medicine

Introduction: The need for a coach to provide feedback and remediation during simulation training is a barrier to widespread adoption. We developed a formative feedback tool (FFT) to provide trainees with specific, formative feedback about their laparoscopic continuous suturing skills. The objective of this study was to compare suturing performance after self-directed training using the FFT with training under a coach. 

Methods and Procedures: In this randomized, open-label, non-inferiority trial, general surgery residents able to perform the FLS intracorporeal single suturing task in ≤ 225 seconds were given 1 training session on a continuous suturing model with a coach and then introduced to the FFT and an accompanying video-based interactive learning tool (VILT). They were randomly assigned to receive 2 additional training sessions with FFT/VILT plus a coach (C) or self-training with FFT/VILT alone (NC). Performance was evaluated by a blinded evaluator pre- and post-training using time/error scores and the FFT.  The primary outcome was change in time/error scores from baseline, with a 20% non-inferiority margin.  The secondary outcome was change in FFT score.  

Results: Nineteen residents (10 C, 9 NC) completed training (median PGY: 4).  Baseline characteristics were similar in both groups, as were median (IQR) time/error scores at baseline (527[343-586] vs. 436[230-633], p=0.21) and after 3 training sessions (709[626-769] vs. 628 [461-751], p=0.21).  Similarly, FFT scores for the C and NC groups were similar at baseline (27[18.3-30.5] vs. 25[22.0-28.5), p=0.97) and after training (37[36-38] vs. 36[34-38], p=0.43).  On subgroup analysis, the C group FFT scores (27[18.3-30.5] vs. 37[36-38], p=0.002) and time/error scores (527[343.3-586.3] vs. 708.5[626-769.3], p=0.0002) both improved significantly over the duration of the study, with a trend in that direction for the NC group.

Conclusion: For residents, improvement in performance on an advanced laparoscopic suturing task was similar using FFT/VILT as feedback alone compared to those who also had coached sessions. Although there is evidence to support the validity of the FFT as a measure of suturing skill, this study suggests that it also provides meaningful and usable feedback.  Coaching when possible, may have a slight benefit over self-training with the FFT, however, the FFT is an effective alternative when expert coaches are not available.  

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