BackgroundMyringotomy with tube insertion can be challenging for junior Otolaryngology residents as it is one of the first microscopic procedures they encounter. The Western myringotomy simulator was developed to allow trainees to practice microscope positioning, myringotomy, and tube placement. This virtual-reality simulator is viewed in stereoscopic 3D, and a haptic device is used to manipulate the digital ear model and surgical tools.ObjectiveTo assess the face and content validity of the Western myringotomy simulator.MethodsThe myringotomy simulator was integrated with new modules to allow speculum placement, manipulation of an operative microscope, and insertion of the ventilation tube through a deformable tympanic membrane. A questionnaire was developed in consultation with instructing surgeons. Fourteen face validity questions focused on the anatomy of the ear, simulation of the operative microscope, appearance and movement of the surgical instruments, deformation and cutting of the eardrum, and myringotomy tube insertion. Six content validity questions focused on training potential on surgical tasks such as speculum placement, microscope positioning, tool navigation, ear anatomy, myringotomy creation and tube insertion. A total of 12 participants from the Department of Otolaryngology—Head and Neck Surgery were recruited for the study. Prior to completing the questionnaire, participants were oriented to the simulator and given unlimited time to practice until they were comfortable with all of its aspects.ResultsResponses to 12 of the 14 questions on face validity were predominantly positive. One issue of concern was with contact modeling related to tube insertion into the eardrum, and the second was with the movement of the blade and forceps. The former could be resolved by using a higher resolution digital model for the eardrum to improve contact localization. The latter could be resolved by using a higher fidelity haptic device. With regard to content validity, 64 % of the responses were positive, 21 % were neutral, and 15 % were negative.ConclusionsThe Western myringotomy simulator appears to have sufficient face and content validity. Further development with automated metrics and skills transference testing is planned.

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Myringotomy refers to a surgical incision in the eardrum, and it is often followed by ventilation tube placement to treat middle-ear infections. The procedure is difficult to learn; hence, the objectives of this work were to develop a virtual-reality training simulator, assess its face and content validity, and implement quantitative performance metrics and assess construct validity.A commercial digital gaming engine (Unity3D) was used to implement the simulator with support for 3D visualization of digital ear models and support for major surgical tasks. A haptic arm co-located with the stereo scene was used to manipulate virtual surgical tools and to provide force feedback.A questionnaire was developed with 14 face validity questions focusing on realism and 6 content validity questions focusing on training potential. Twelve participants from the

Automated quantitative performance metrics were successfully developed and implemented, and construct validity was established by discriminating between expert and novice participants.

BackgroundAfatinib is a potent, irreversible second-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor which has demonstrated efficacy in advanced non-small cell lung cancer (NSCLC) patients harboring either common or uncommon EGFR mutations. However, data on its activity against brain metastases are limited. This study aimed to retrospectively evaluate the efficacy and safety of afatinib as first-line treatment for EGFR-mutant NSCLC patients with brain metastases.MethodsTreatment-naive advanced NSCLC patients harboring EGFR mutations and brain metastases treated with afatinib were retrospectively reviewed to assess the central nervous system (CNS) efficacy and also the systematic benefits.ResultsTotally 43 patients with measurable or non-measurable brain metastases were enrolled in the CNS full analysis (cFAS) set. Among them, 23 patients with measurable brain metastases were included in the CNS evaluable for response (cEFR) set. The CNS ORR was 48.8% (95% CI, 33.3 - 64.5%) in the cFAS set and 82.6% (95% CI, 61.2 - 95.0%) in the cEFR set, respectively. CNS mDoR was 8.9 months (95% CI, 4.7 - 13.1 months) and CNS mPFS was 12.7 months (95% CI, 6.9 - 18.5 months) in the cFAS set. In the subgroup analysis stratified by EGFR mutation types, CNS ORR of cEFR set in the common mutation cohort was 100% (95% CI, 75.3 - 100%) and 60% (95% CI, 26.2 - 87.8%) in the uncommon mutation cohort (p = 0.024); CNS ORR of cFAS set was 57.7% (95% CI, 36.9 - 76.6%) and 35.3% (95% CI, 14.2 - 61.7%), respectively (p = 0.151). CNS mPFS was 14.4 months in patients with common mutations and 6.1 months in patients with uncommon mutations (hazard ratio, 0.47; 95% CI, 0.22 - 1.00; p = 0.045). Patients with common mutations showed a significantly lower cumulative incidence of CNS failure than uncommon mutation cohort (p = 0.0026). Most of patients experienced grade 1/2 treatment-related adverse events.ConclusionsFirst-line afatinib demonstrated encouraging efficacy on brain metastases in NSCLC patients harboring either common or major uncommon EGFR mutations in a real-world setting, with manageable toxicities. Patients with common mutations showed better CNS outcomes than those with uncommon mutations.