Simulation-based Ultrasound Training to Improve Patient Comfort and Decrease the Need for Re-examination. A Randomized Trial.

Background Ultrasonography has become increasingly used in many medical specialties over the last decades as smaller and less expensive ultrasound equipment has become available. Although ultrasound imaging traditionally is considered safe, its use is highly operator dependent (EFSUMB 2010). The lack of sufficient operator skills can lead to diagnostic errors that eventually compromise patient safety due to unnecessary tests or interventions (Moore & Copel 2011). A recent report from the British National Health Service (NHS) analyzed maternity claims reported to the NHS over the past decade and identified antenatal fetal ultrasound investigations as one of the four major risk areas in obstetric care (NHS 2012). Traditional ultrasound training is challenged with long learning curves and lack of standardization of competency-based training (Salvesen et al. 2010). Given the long learning curve characterizing traditional clinical training (Jang et al. 2010), proficiency in terms of independence and acceptable diagnostic accuracy may not occur during the first many months of training. Thus, some residents may not be sufficiently trained to manage independent ultrasound examinations expected from them safely. Accelerating learning curves is therefore essential from a patient safety perspective and for patient discomfort during intimate examinations such as transvaginal ultrasound scans. However, it may also be important from an organizational viewpoint as insufficiently trained residents may not be as effective in managing patients as those, who are trained until proficiency.

Simulation-based training has become increasingly used in several medical domains because it provides a safe environment to practice. Virtual Reality (VR) simulation has previously been shown to improve technical performance and shorten operation time in laparoscopic surgery (Larsen et al. 2009) and this type of training may therefore be useful as an adjunct to supervised clinical ultrasound practice. In previous studies of the effect of VR simulation, control groups have been assigned 'traditional training', which often means 'no training'. Consequently, it is not known if VR simulation - including ultrasound simulation - is superior to optimal clinical training using real patients. Furthermore, no studies have explored the effects of ultrasound simulation on patient related outcomes such as diagnostic accuracy, patient discomfort and their perception of safety during the ultrasound examinations. The effects on an organizational level such as the use of time per ultrasound examination, the need for re-examination by a senior clinician or the need for ambulatory control due to diagnostic uncertainty are also unknown.

Hence, we aim to explore the following research questions:

1. What are the effects of simulation-based training compared to traditional training in a group of OB/GYN residents without prior ultrasound experience, on the following outcomes:

1. Patients' discomfort levels and perception of safety immediately after a transvaginal ultrasound examination in a gynecological care unit.
2. Need for re-examination of the patients by a clinical supervisor after the initial examination.
3. Number of ambulatory controls needed due to diagnostic uncertainty.