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Objective: The objective was to monitor the effectiveness of the etonogestrel implant clinical training program through a voluntary active monitoring program (AMP).Study Design: US health care providers underwent mandatory training by the manufacturer on etonogestrel implant insertion, localization and removal. After training, health care providers could enroll in a voluntary AMP to provide outcome data to meet a postmarketing commitment of the manufacturer with the US Food and Drug Administration (FDA). Those who volunteered completed and faxed forms to the manufacturer after implant insertion and removal detailing the procedure and device-related outcomes, including insertion-, localization- or removal-associated events. Experts reviewed outcome data quarterly, which the Sponsor then reported to the FDA.Results: Among 42,337 health care providers completing the training program, 4294 (10.1%) volunteered to participate in the AMP. The 26,198 forms submitted over 6.4 years included more insertion (n=20,497) forms than removal forms (n=5701). The volunteers reported 646 events on 566 (2.2%) forms related to insertion (n=197), localization (n=34), removal (n=357) and "other" (n=58). Clinically important events included noninsertion (n=4), serum etonogestrel positive but implant not found (n=1), and possible nerve (n=66) or vascular (n=5) injury. The reports did not include any insertion-, localization- or removal-associated hospitalizations. Eight (0.14%) removal reports described referral for surgical implant removal.Conclusion: Events related to insertion, localization or removal of the etonogestrel implant are uncommon among US providers who received mandatory training in the use of the implant.Implications: This report presents results from the first mandatory US contraceptive training program. Health care providers volunteered to report information about etonogestrel implant insertion, localization and removal. Although the data do not demonstrate whether a mandatory program improves outcomes, they elucidate the utility and real-life experience that clinical training programs can provide. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate obstetrics and gynecology resident physicians' performance following a simulation curriculum on dilation and evacuation (D&E) procedures.Study Design: This study included two phases: simulation curriculum development and resident physician performance evaluation following training on a D&E simulator. Trainees participated in two evaluations. Simulation training evaluated participants performing six cases on a D&E simulator, measuring procedural time and a 26-step checklist of D&E steps. The operative training portion evaluated residents' performance after training on the simulator using mastery learning techniques. Intra-operative evaluation was based on a 21-step checklist score, Objective Structured Assessment of Technical Skills (OSATS), and percentage of cases completed.Results: Twenty-two residents participated in simulation training, demonstrating improved performance from cases one and two to cases five and six, as measured by checklist score and procedural time (p<.001 and p=.001, respectively). Of 10 participants in the operative training, all performed at least three D&Es, while seven performed at least six cases. While checklist scores did not change significantly from the first to sixth case (mean for first case: 18.3; for sixth case: 19.6; p=.593), OSATS ratings improved from case one (19.7) to case three (23.5; p=.001) and to case six (26.8; p=.005). Trainees completed approximately 71.6% of their first case (range: 21.4-100%). By case six, the six participants performed 81.2% of the case (range: 14.3-100%).Conclusions: D&E simulation using a newly-developed uterine model and simulation curriculum improves resident technical skills. Simulation training with mastery learning techniques transferred to high level of performance in OR using checklist. The OSATS measured skills and showed improvement in performance with subsequent cases.Implications: Implementation of a D&E simulation curriculum offers potential for improved surgical training and abortion provision. [ABSTRACT FROM AUTHOR]