Comparison of practice vs theory model training for vacuum-assisted delivery: A randomized controlled trial

Objective: To assess the effect of two modalities of simulation training on acquisition/retention of skills for performing operative vaginal delivery. Design: Randomized, controlled, single-centre study. Setting: A tertiary referral hospital in Italy. Participants: Twenty residents from a single university programme and two young specialists. Intervention: Group 1 had an individual training session with a single senior specialist using a fixed simulator model. After the session, trainees watched a pre-recorded 1-h lecture on vacuum-assisted operative vaginal delivery. Group 1 repeated the simulator session using the same test after 8-12 weeks and 12 months. Group 2 watched the pre-recorded lecture then undertook the same sessions as Group 1. Video recordings of all test performances were evaluated by five specialists in a blinded manner. Main outcome measure: Each procedure was evaluated using a Global Rating Scale (GRS), scored with 0-5 points for each item on an Objective Structured Assessment of Technical Skills (OSATS) dataset with seven items (total 35 points). OSATS were evaluated over time, compared for the whole population, and weighted for route and year of residency. The primary outcome was comparison of the effectiveness of training between the two groups based on year of residency by assessing videos of the baseline test and GRS for OSATS scores. The secondary outcome was overall retention of skills at 8-12 weeks and 12 months. Results: Twenty-two participants were recruited and randomized to either Group 1 (n = 11) or Group 2 (n = 11). Five participants did not complete follow-up. The primary outcome of GRS for OSATS scores at time 0 differed significantly between groups for total GRS score, and 'Call for help' and 'Explanation to woman and relatives' item scores (p = 0.002 and p = 0.007, respectively). In a multiple linear regression analysis, OSATS scores were not independently influenced by year of residency. At 8-12-week follow-up, the 'Call for help' item score showed a significant improvement in Group 1 (p = 0.018), although this was not confirmed when year of residency was included as an independent variable. At 12-month follow-up, none of the item scores demonstrated a significant change (p = 0.033). Year of residency did not influence the difference between groups. One-way analysis of variance found significant differences between the groups for 'Localization of the flexion point' (p = 0.005), 'Traction of vacuum cup' (p = 0.039) and 'Use of second hand of the operator' (p = 0.009) item scores and total GRS score (p = 0.007). The values weighted by year of residency did not demonstrate any significant difference. The secondary outcomes evaluated all the candidates of both groups for retention of technical skills over time. A significant effect of time was found for total GRS score (p < 0.001) and OSATS item scores. Conclusions: Independent of the sequence of theoretical teaching and simulation training, trainees demonstrated high retention - and, actually, improvement - of technical skills for operative vaginal delivery at 12-month follow-up.