Essentials in Minimally Invasive Gynecology Manual Skills Construct Validation Trial

Abstract

Objective: To establish validity evidence for the Essentials in Minimally Invasive Gynecology laparoscopic and hysteroscopic simulation systems.

Methods: A prospective cohort study was IRB approved and conducted at 15 sites in the United States and Canada. The four participant cohorts based on training status were: 1) novice (postgraduate year [PGY]-1) residents, 2) mid-level (PGY-3) residents, 3) proficient (American Board of Obstetrics and Gynecology [ABOG]-certified specialists without subspecialty training); and 4) expert (ABOG-certified obstetrician-gynecologists who had completed a 2-year fellowship in minimally invasive gynecologic surgery). Qualified participants were oriented to both systems, followed by testing with five laparoscopic exercises (L-1, sleeve-peg transfer; L-2, pattern cut; L-3, extracorporeal tie; L-4, intracorporeal tie; L-5, running suture) and two hysteroscopic exercises (H-1, targeting; H-2, polyp removal). Measured outcomes included accuracy and exercise times, including incompletion rates.

Results: Of 227 participants, 77 were novice, 70 were mid-level, 33 were proficient, and 47 were experts. Exercise times, in seconds (±SD), for novice compared with mid-level participants for the seven exercises were as follows, and all were significant (P<.05): L-1, 256 (±59) vs 187 (±45); L-2, 274 (±38) vs 232 (±55); L-3, 344 (±101) vs 284 (±107); L-4, 481 (±126) vs 376 (±141); L-5, 494 (±106) vs 420 (±100); H-1, 176 (±56) vs 141 (±48); and H-2, 200 (±96) vs 150 (±37). Incompletion rates were highest in the novice cohort and lowest in the expert group. Exercise errors were significantly less and accuracy was greater in the expert group compared with all other groups.

Conclusion: Validity evidence was established for the Essentials in Minimally Invasive Gynecology laparoscopic and hysteroscopic simulation systems by distinguishing PGY-1 from PGY-3 trainees and proficient from expert gynecologic surgeons.

Fig. 1.. Essentials in Minimally Invasive Gynecology laparoscopic exercises. A. L-1 sleeve-peg transfer. Participants were provided two Maryland grasping forceps. B. L-2 pattern cut. Each participant was given a Maryland grasping forceps and curved laparoscopic scissors to cut the circle pattern. C. L-3 extracorporeal tie. Participants were provided their choice of two laparoscopic needle drivers (left inset) or one needle driver and a Maryland grasping forceps. Ties were thrown extracorporeally (left) and transferred into the trainer box using one of two choices of knot manipulators (center and right insets). D. L-4 intracorporeal knot. The same choice of needle drivers provided for L-3 used to form a knot with three intracorporeal throws. E. L-5 running suture. The same choice of needle drivers was offered (inset) to close the fenestration in the long Penrose with five paired targets. Photos of participants reprinted from Essentials in Minimally Invasive Gynecology manual skills pilot validation trial. Munro MG, Brown AN, Saadat S, Gomez N, Howard D, Kahn B, Stockwell E, et al. J Minim Invasive Gynecol 2020; 27:518–534, Copyright 2020, with permission from Elsevier.

Munro. Essentials in Minimally Invasive Gynecology. Obstet Gynecol 2020.

Fig. 2.. Study flow. Potential participants were identified by the site principal investigator and offered the web-based qualification survey to determine qualification for the trial based on residency year, or postresidency status, as well as exposure to laparoscopic and hysteroscopic surgery and surgical simulation. Those who could be included as participants were provided a voucher containing a unique and anonymized identification number for scheduling and then presentation at the time of on-site testing. Testing was performed by an Essentials in Minimally Invasive Gynecology (EMIG) study team on site. Trained proctors supervised registration, orientation, and the acquisition of study data for each of the five laparoscopic and two hysteroscopic exercises.

Munro. Essentials in Minimally Invasive Gynecology. Obstet Gynecol 2020.

Fig. 3.. Laparoscopic exercise completion times. Mean exercise times in seconds for the four cohorts (standard error of the mean) for each of the L-1 to L-5 exercises. At the base of each bar is the number of participants included in the calculation for each exercise. Variable numbers of participants reflect the absence of recorded video for some participants because all required central verification. If a participant timed out, not completing the exercise, they were assigned the maximum allowable time. The error bars indicate standard error of the mean. PGY, postgraduate year; FMIGS, fellowship in minimally invasive gynecologic surgery.

Munro. Essentials in Minimally Invasive Gynecology. Obstet Gynecol 2020.

Fig. 4.. Laparoscopic exercise did-not-complete rates. Percentage of participants not completing the task within the allotted time for each of the L-1 through L-5 exercises. For these, the maximum time allowed for the exercise was assigned for the time calculations shown in Figure 3 and in Table 2. PGY, postgraduate year; FMIGS, fellowship in minimally invasive gynecologic surgery.

Munro. Essentials in Minimally Invasive Gynecology. Obstet Gynecol 2020.

Fig. 5.. H-1 and H-2 completion times. Completion times in seconds (±standard error of the mean) for the two hysteroscopic exercises, by cohort. The denominators vary and are less than the overall cohort because a complete video was necessary to centrally validate the participants' time. PGY, postgraduate year; FMIGS, fellowship in minimally invasive gynecologic surgery.

Munro. Essentials in Minimally Invasive Gynecology. Obstet Gynecol 2020.