Auditory brainstem implants: an analysis of adverse events in the MAUDE database.

OBJECTIVE: Auditory Brainstem Implants (ABI) are used to restore hearing in patients lacking appropriate cochlear anatomy and/or cochlear nerve. The objective of this study was to examine the Manufacture and User Facility Device Experience (MAUDE) database to analyze adverse events. STUDY DESIGN: This is a study of a multi-institutional database maintained by the US FDA. SETTING: A database analysis was performed via collaboration of multiple clinicians at tertiary referral centers. METHODS: The MAUDE database was queried for Medical Device Reports (MDRs) relating to ABIs. MDRs were identified using the advanced search term "Implant, Auditory Brainstem" and reviewing all reports with the basic search term "Brainstem Implant". All collected reports were individually reviewed. RESULTS: A total of 265 individual patient reports were reviewed, of which 55 reports met inclusion criteria. Reports regarding audiologic outcome included failure to provide hearing benefit (n = 27), implant failure/device malfunction (n = 10), and device non-use (n = 6). Postoperative complications included local skin infection (n = 3), CSF leak (n = 3), elevated ICP (n = 1), surgical site dehiscence (n = 1), swelling (n = 1), seroma formation requiring drainage (n = 1), and meningitis (n = 2). Two patients had dislodged magnets during 1.5 Tesla MRI acquisition. There were 35 instances of full explantation of the device and 1 partial removal; 13 patients had a new device implanted following explantation. CONCLUSIONS: Poor hearing results, device failure, and non-use were commonly reported causes for explanation in this analysis. This information can aid physicians in counseling patients and family members and managing device expectations.

Virtual surgical planning for mandibular reconstruction in an abbreviated admission pathway.

OBJECTIVES: Virtual Surgical Planning (VSP) creates individualized surgical plans for free flap reconstruction of mandibular defects. Prior studies indicate that VSP can offer cost benefits due to reduced operative time and length of stay (LOS). We assessed the impact of VSP in the context of a validated postoperative abbreviated LOS clinical pathway. METHODS: This study assessed patients undergoing VSP vs conventional fibular free flap reconstruction for mandibular defects (12/2015-10/2020) and their operative time, ischemia time, and LOS were evaluated. RESULTS: Forty-four patients underwent VSP reconstruction, while 52 patients underwent conventional reconstruction for mandibular defects. VSP was associated with significantly lower total operative time (6 h and 57 mins vs 7 h and 54 mins, p = 0.011), but not length of stay or ischemia time. Total OR time was significantly increased with increasing number of segments needed in both the VSP group (p = 0.002) and the conventional group (p = 0.015). CONCLUSION: Shorter operative times and LOS have been attributed to the use of VSP in free tissue transfers. It is argued that these reductions offset the added cost of VSP. Our study indicates that there is no cost benefit for VSP utilization due to a significantly reduced operative time with no impact on length of admission in an abbreviated admission clinical pathway following free tissue transfer.

Improved Confidence and Clinical Application: The Effects of a Longitudinal Suture Curriculum for Medical Students.

OBJECTIVE: The ability to competently suture is an expected skill for graduating medical students, but many graduates report feeling unprepared to perform this skill. This study aimed to improve student confidence and clinical readiness for third-year clerkships by implementing a novel, mandatory 7.5-hour longitudinal suturing skills curriculum across the first 3 years of medical school. METHODS: The required suturing skills curriculum was implemented for all medical students throughout the first 3 years of medical school at a large academic health center in the mid-South United States. Precurriculum (n = 167) and postcourse (n = 148) surveys were administered to first-year students in the first year of the curriculum (2017-2018), and a parallel follow-up survey was administered to this cohort in 2020 after students completed their clinical clerkship year (n = 82). Aggregate changes in students' survey responses were analyzed for proper instrument position, simple interrupted sutures, and instrument ties using independent groups Mann-Whitney U tests and Rosenthal correlation coefficients for effect sizes. RESULTS: Statistically significant improvement from pre to post was observed in student comfort in performing three basic skills: proper instrument position (P < 0.001), simple interrupted suture (P < 0.001), and instrument ties (P < 0.001). These pre-post gains were sustained at 2-year follow-up (P < 0.001). Also, the majority of students (66%) reported they were very or completely prepared to suture wounds during their clerkships. Most (83%) also reported they had successfully sutured patient wounds during third-year clerkships without needing significant direction or guidance. CONCLUSIONS: We found that a longitudinal suture curriculum with dedicated faculty involvement can improve student confidence in suturing and overall preparedness for third-year clerkships. Although the study is limited to ratings of student comfort and self-reported performance as well as some attrition of responses at postcourse survey and postclerkship survey, the findings highlight the importance of a focused curriculum dedicated to teaching basic suturing skills. Our findings also contribute to the limited body of work examining longitudinal surgical skills development for medical students.

Otologic use of porcine small intestinal submucosal graft (biodesign): A MAUDE database review.

OBJECTIVE: To review and summarize reported adverse events related to the use of porcine small intestine submucosal grafts (Biodesign™) in otologic procedures. STUDY DESIGN: Retrospective cross-sectional analysis. SETTING: Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. MATERIAL AND METHODS: The MAUDE database was queried for all medical device reports (MDR) related to otologic use of Biodesign™ (Cook Medical, Bloomington, IN) from January 2016 to November 2022. Adverse events (AEs) were identified by reviewing all reports with the basic search term "Biodesign" and "Biodesign, Otologic". Reports were individually reviewed and categorized with special attention to AEs. RESULTS: A total of 500 reports were reviewed. Since FDA approval of Biodesign™ in 2016, there have been 5 adverse events reported for use of Biodesign™ during otologic surgery (tympanoplasty, n = 3; stapes surgery, n = 2). All reported events described patient injury, and all cases required at least one revision surgery. Four cases described significant foreign body inflammatory reactions. Complications included hearing loss (n = 3), severe otalgia (n = 2), persistent perforation (n = 2), vertigo (n = 2), and facial paralysis (n = 1). CONCLUSION: The use of porcine small intestinal submucosal graft has been thought to be a safe and effective option for otologic surgery, with the advantage of availability without graft harvest in minimally invasive endoscopic surgery. However, foreign body or granulomatous reactions have been documented and should be considered prior to its use in otologic surgery.

Outcomes After Pharyngeal Flap Surgery in Children: A Comparison of Lined Versus Unlined Flaps.

OBJECTIVE: The addition of a uvular flap (PFU) was hypothesized to improve outcomes over standard pharyngeal flap (PF) for correction of velopharyngeal dysfunction. We report differences in outcomes of PF vs PFU at our institution. DESIGN: Retrospective cohort study. SETTING: Tertiary children's hospital. PATIENTS: Children who underwent PF or PFU with the three highest-volume surgeons at our institution in 2004-2017. OUTCOME MEASURES: We examined differences in complications between groups, frequency and type of revision surgery, and speech-related measures including nasometry, pressure-flow testing (PFT) and perceptual speech analysis (PSA). RESULTS: 160 patients were included, 41 PF and 119 PFU (including 18 with Hogan technique). Patients undergoing PFU were older (7.6 yr vs 6.0 yr; p = 0.037) and more likely to have cleft palate (63/119 vs 14/41; p = 0.047). There was no significant difference in complications. With PFU, a decrease in airspace contracting revision surgeries was noted, (4/119 vs 8/41; p = 0.002) which drove a reduction in revision surgery of all types (7/119 vs 13/41; p = 0.033). However, patients that did undergo revision surgery after PFU underwent more revision procedures (p = 0.032). PSA scores were found to be lower (less hypernasal) after PFU (p = 0.009) compared to PF. Objective speech measures had varying results, with nasometry demonstrating a significant difference between groups (p = 0.001), while PFT (p = 0.525) did not demonstrate a statistical difference. CONCLUSION: The use of a uvular lining flap in pharyngeal flap surgery may be associated with improved long term surgical outcomes, including both improvements in subjective and objective testing and a lower rate of revision surgery, without increased complications.

Microlearning activities improve student comprehension of difficult concepts and performance in a biochemistry course.

INTRODUCTION: Students must rapidly learn and retain fundamental basic science knowledge in a doctor of pharmacy curriculum. Active learning stimulates engagement, reinforces concept understanding, and promotes retention of knowledge. The purpose this study was to determine if introducing game-based active recall and critical thinking microlearning activities improved student comprehension of challenging concepts, exam performance, and successful completion of a biochemistry course. METHODS: Microlearning activities were generated using Articulate Storyline software. Questions and problems were embedded in gamification-type activities to reinforce challenging biochemistry concepts and improve critical thinking. Activities were published on Blackboard and student performance was recorded. Students were divided into performance groups using their first exam scores. Student's exam scores were related to results from corresponding microlearning. Statistical analysis of results was performed to compare exam results with outcomes of microlearning activities. RESULTS: Student performance on exams and final scores positively correlated with successful completion of microlearning activities. Students who successfully completed more microlearning activities performed significantly better on all exams in comparison with students who completed few microlearning activities. Students who initially struggled with the material but completed more microlearning improved their performance on exams and passed the course with a higher score. In contrast, students who struggled and completed fewer activities failed to improve their exam and course performance. CONCLUSIONS: Active recall and critical thinking microlearning activities enhanced knowledge retention and comprehension of challenging biochemical concepts. Microlearning scores positively correlated with student exam performance in a biochemistry course, especially amongst students struggling with the material.

Impact of Surgery for Velopharyngeal Insufficiency on Eustachian Tube Function in Children: Pharyngeal Flap Versus Sphincter Pharyngoplasty.

OBJECTIVE: Velopharyngeal insufficiency (VPI) is a common speech disorder in patients with a history of cleft palate (CP) or 22q11.2 deletion syndrome. Pharyngeal flap (PF) and sphincter pharyngoplasty (SP) are 2 common surgeries to treat this disorder by decreasing unwanted nasal air emission and hypernasal resonance. Because Eustachian tube dysfunction (ETD) in patients with CP may be more frequent after surgery for VPI, we examined whether ETD was associated with either type of surgery. DESIGN: Retrospective cohort study. SETTING: Children's hospital-based tertiary referral center. PATIENTS: A total of 225 children with VPI who underwent primary PF (201) or SP (24) between 2006 and 2017. OUTCOME MEASURES: We examined differences in risk of ETD according to both surgical groups and proxies for postoperative nasal obstruction. These proxies included postoperative resonance measures and development of obstructive sleep apnea (OSA). RESULTS: Both surgical groups had similar preoperative measures, except the PF group had higher hypernasality by PSA. Postoperatively, the PF group demonstrated lower hypernasal resonance by nasometry and PSA. There were no differences between PF and SP groups with regard to ETD. Proxies for postoperative nasal obstruction also were not predictive of postoperative ETD. Degree of CP and younger age were found to be risk factors for ETD. CONCLUSION: There was no significant difference in the effects of PF and SP on ETD in this study. Neither lower hypernasality nor incidence of OSA had any impact on ETD. Degree of CP and younger age were the only significant risk factors for ETD that this study identified.

Altered social trajectories and risks of violence among young Syrian women seeking refuge in Turkey: a qualitative study.

BACKGROUND: There is limited evidence regarding the ways in which displacement disrupts social norms, expectations and trajectories for adolescent girls and young women and the resulting impacts on their risks of violence. This knowledge gap is especially marked with regards to Syrian adolescent girls and young women seeking refuge in Turkey. We explored risks of gender-based violence against Syrian adolescent girls and young women in Turkey and examined how these risks were shaped by their displacement. METHODS: Data were collected in August 2016 in Izmir, Turkey through five sex-specific focus group discussions with Syrian adolescents and young people (aged 15-25 years) and two mixed gender focus group discussions with Syrian adults (18 years and older). Group discussions covered the issues facing Syrian adolescents and young women in Turkey, and how these were influenced by their displacement. Discussions in Arabic were audio-recorded, transcribed and translated into English. Data were coded inductively, and analysed thematically. RESULTS: Syrian adolescent girls and young women expressed an increased sense of vulnerability to violence since their displacement. Due to financial strains and limited educational opportunities, they were often encouraged by parents to work or marry, both of which they perceived to increase the risks of violence. In contrast, some adults suggested that marriage could protect adolescent girls and young women from risks of violence associated with working. Being alone outside the home was viewed as risky by all participants due to pervasive sexual, verbal and physical harassment, aggression, and even kidnapping attempts. To limit these risks, many parents reported keeping adolescent girls and young women at home, or ensuring that they were accompanied by male relatives when in public. CONCLUSIONS: Syrian adolescent girls and young women face multiple risks of violence following displacement related to altered social trajectories. Some family-based strategies to protect young women from violence could reinforce restrictive gender norms and increase risks of violence. Interventions to address violence should include providing safe spaces, access to education and safe transport for young women, and financial support for families as well as community-based interventions to address the daily risks of sexual harassment in public spaces.