Comparison of Pediatric Otolaryngology clinical and operative case volume among surgical specialties in the COVID-19 pandemic.

OBJECTIVES: To report changes in clinical and surgical volume impacting a Pediatric Otolaryngology division one year prior to and following the onset of the COVID-19 pandemic in comparison to five other pediatric surgical subspecialties. METHODS: The number of clinical visits and surgical cases per month for six pediatric surgical specialties (Otolaryngology, Orthopedic Surgery, Urology, Neurosurgery, Plastic Surgery, and General Surgery) for 12 months prior to the pandemic and 12 months following the onset of the pandemic was collected. Poisson regression analysis was performed for the number of visits and cases per season adjusting for specialty, season, staffing changes, and the pandemic to determine adjusted rate ratios (aRR) post-pandemic for the surgical fields compared to Otolaryngology. RESULTS: A percentage decrease in median visits per paired month (-15.63%, IQR = -23.01, -1.66) and operative cases (-19.86%, IQR = -29.39, -10.17) was seen for Pediatric Otolaryngology. Regression analysis showed a significant negative effect on the number of visits (aRR = 0.74, 95% CI = 0.70-0.77) and cases (aRR = 0.65, 95% CI = 0.60-0.71) due to the pandemic. While many of the other specialties had predicted reductions in volume (notably Orthopedics), they all experienced significant predicted increases in productivity following the pandemic compared to Otolaryngology. CONCLUSIONS: These findings suggest that Pediatric Otolaryngology is particularly vulnerable to this change in clinical pattern, which could be due to a decline in community infections from mask wearing and social distancing, and may result in a longer-term volume deficit when compared to other pediatric surgical subspecialties.

Systemic Bevacizumab for Treatment of Respiratory Papillomatosis: International Consensus Statement.

OBJECTIVES/HYPOTHESIS: The purpose of this study is to develop consensus on key points that would support the use of systemic bevacizumab for the treatment of recurrent respiratory papillomatosis (RRP), and to provide preliminary guidance surrounding the use of this treatment modality. STUDY DESIGN: Delphi method-based survey series. METHODS: A multidisciplinary, multi-institutional panel of physicians with experience using systemic bevacizumab for the treatment of RRP was established. The Delphi method was used to identify and obtain consensus on characteristics associated with systemic bevacizumab use across five domains: 1) patient characteristics; 2) disease characteristics; 3) treating center characteristics; 4) prior treatment characteristics; and 5) prior work-up. RESULTS: The international panel was composed of 70 experts from 12 countries, representing pediatric and adult otolaryngology, hematology/oncology, infectious diseases, pediatric surgery, family medicine, and epidemiology. A total of 189 items were identified, of which consensus was achieved on Patient Characteristics (9), Disease Characteristics (10), Treatment Center Characteristics (22), and Prior Workup Characteristics (18). CONCLUSION: This consensus statement provides a useful starting point for clinicians and centers hoping to offer systemic bevacizumab for RRP and may serve as a framework to assess the components of practices and centers currently using this therapy. We hope to provide a strategy to offer the treatment and also to provide a springboard for bevacizumab's use in combination with other RRP treatment protocols. Standardized delivery systems may facilitate research efforts and provide dosing regimens to help shape best-practice applications of systemic bevacizumab for patients with early-onset or less-severe disease phenotypes. LEVEL OF EVIDENCE: 5 Laryngoscope, 131:E1941-E1949, 2021.

Simulation of Pediatric Endoscopic Cricoid Reduction and Expansion.

Endoscopic cricoid expansion and reduction are newer approaches to the management of pediatric bilateral vocal fold immobility and postlaryngotracheal reconstruction glottic insufficiency, respectively. These procedures offer a less invasive, endoscopic alternative to procedures that typically required open management with a more prolonged recovery. These technically demanding procedures are currently performed only in select centers, and there is no currently described training model for practicing them. We present a modification to a laryngeal dissection station that allows for simulation of endoscopic cricoid reduction and expansion with excised larynges. The model allows trainees to practice endoscopic posterior cricoid exposure, incision of the cricoid cartilage, placement of a simulated costal cartilage graft for expansion, and endoscopic suturing for reduction. Development of simulators for procedures that are infrequently performed have the potential to help trainees reach surgical competency faster and more safely.

Comparing the Nonlinear Dynamic Acoustic Parameters of Healthy Adult and Pediatric Voices.

OBJECTIVES:: The aims of this study were to compare nondysphonic adult and pediatric voices using linear and nonlinear acoustic parameters and to evaluate the ability of adult spectrum convergence ratio (SCR) and rate of divergence (ROD) reference values to correctly identify a pediatric voice type as periodic or aperiodic. METHODS:: Twenty adult and 36 pediatric nondysphonic voice samples were collected and analyzed using linear and nonlinear acoustic parameters. Absence of voice disorder was confirmed using perceptual acoustic and spectral analysis. Mean values for jitter, shimmer, SCR, and ROD were compared between adults and children, across specific age groups, and within genders. Using adult reference values for SCR and ROD, samples were classified as primarily periodic or aperiodic and typed using spectral analysis. Rates of accurate typing were also compared between subject groups. RESULTS:: Overall, jitter and shimmer were similar among the adult and pediatric age groups. ROD was significantly different among the 3 pediatric and 1 adult group; the pediatric age groups were similar to one another. Adult SCR was also significantly different from all of the pediatric age groups. In adult men, ROD and SCR were significantly different from all of the pediatric age groups; the pediatric age groups were similar to one another. In female subjects, ROD was significantly different among all age groups. The ROD and SCR reference values were significantly better at categorizing adult voice types compared with pediatric voice types. CONCLUSIONS:: In healthy subjects, SCR and ROD have discriminatory power for identifying adult versus pediatric voices, while jitter and shimmer cannot differentiate between the 2 groups. However, age- and gender-specific pediatric reference values must be determined to accurately classify voice types using SCR and ROD.

Mucosal wave measurement and visualization techniques.

Organized vibration of the vocal folds is critical for high-quality voice production. When the vocal folds oscillate, the superficial tissue of the vocal fold is displaced in a wave-like fashion, creating the so-called "mucosal wave." Because the mucosal wave is dependent on vocal fold structure, physical alterations of that structure cause mucosal wave abnormalities. Visualization and quantification of mucosal wave properties have become useful parameters in diagnosing and managing vocal fold pathology. Mucosal wave measurement provides information about vocal fold characteristics that cannot be determined with other assessment techniques. Here, we discuss the benefits, disadvantages, and clinical applicability of the different mucosal wave measurement techniques, such as electroglottography, photoglottography, and ultrasound and visualization techniques that include videokymography, stroboscopy, and high-speed digital imaging. The various techniques and their specific uses are reviewed with the intention of helping researchers and clinicians choose a method for a given situation and understand its limitations and its potential applications. Recent applications of these techniques for quantitative assessment demonstrate that additional research must be conducted to realize the full potential of these tools. Evaluations of existing research and recommendations for future research are given to promote both the quantitative study of the mucosal wave through accurate and standardized measurement of mucosal wave parameters and the development of reliable methods with which physicians can diagnose vocal disorders.

Effect of sildenafil citrate on the male sexual experience assessed with the Sexual Experience Questionnaire: a multicenter, double-blind, placebo-controlled trial with open-label extension.

INTRODUCTION: The Sexual Experience Questionnaire (SEX-Q) enables quick and easy assessment of functional, emotional, and satisfaction-related aspects of the sexual experience in men with erectile dysfunction (ED). AIM: To assess correlations between improvement on the SEX-Q and outcomes on other validated questionnaires. METHODS. Men with ED (score < or =25 on the Erectile Function domain of the International Index of Erectile Function [IIEF]) who had used less than or equal to six doses of any phosphodiesterase 5 inhibitor (none within 6 months) were randomized to 10 weeks of double-blind, placebo-controlled (DBPC) flexible-dose sildenafil citrate (50 or 100 mg, as needed), followed by 6 weeks of open-label (OL) sildenafil. MAIN OUTCOME MEASURES: SEX-Q, IIEF, Quality of Erection Questionnaire (QEQ), Self-Esteem and Relationship (SEAR) Questionnaire, Erection Hardness Score (EHS), successful intercourse attempts (SIAs), Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), and global efficacy questions (GEQs). RESULTS: Compared with the placebo group (N = 105), the sildenafil group (N = 104) at DBPC end of treatment (EOT) had significantly more improvement (P < 0.05) on all SEX-Q, IIEF (except the Sexual Desire domain), QEQ, and SEAR outcomes, more frequent SIAs and EHS 3 (hard enough for penetration but not completely hard) or EHS 4 (completely hard) erections (odds ratio [OR], 2.52 and 3.46, respectively), EHS 4 erections four times as often (OR, 6.41), more men satisfied with treatment (EDITS; OR, 2.6), approximately twice as many men with improved erections (GEQ1; OR, 5.8) and ability to have sexual intercourse (GEQ2; OR, 5.4), and GEQ3 scores that indicated better sex (P < 0.0001). SEX-Q score improvements correlated positively with all other outcomes. At OL EOT, most outcomes were >60% (and approximately half were > or =80%) of the maximum positive result. CONCLUSIONS: SEX-Q change scores correlate with several other functional, emotional, and satisfaction-related outcomes in men treated with sildenafil for ED, allowing a simple and focused evaluation of the sexual experience.

An evaluation of semen characteristics in men 45 years of age or older after daily dosing with tadalafil 20mg: results of a multicenter, randomized, double-blind, placebo-controlled, 9-month study.

OBJECTIVES: Assess the effects on spermatogenesis of daily tadalafil 20mg over three spermatogenesis cycles in men >or= 45 yr. METHODS: In this double-blind, placebo-controlled, noninferiority study, healthy men (or with mild erectile dysfunction) were randomized to receive tadalafil 20mg (n=125) or placebo (n=128) for 9 mo followed by a 6-mo, treatment-free period. Semen and serum samples were provided at baseline and every 10-12 wk. The primary outcome was the proportion of subjects with >or= 50% reduction in sperm concentration at end point. Secondary outcomes included sperm concentration, number per ejaculate, motility and morphology; serum concentrations of testosterone, luteinizing and follicle-stimulating hormones; and tolerability. RESULTS: Of 253 men enrolled, 191 (75%) completed treatment phase: 2 of 96 (2.1%, placebo) and 12 of 95 (12.6%, tadalafil) subjects had >or= 50% reduction in sperm concentration. Tadalafil was noninferior to placebo because the upper 95% confidence interval for the difference in proportions of tadalafil and placebo subjects with a >or= 50% reduction in sperm concentration was 17.5%, significantly less than the prespecified noninferiority margin of 20% (p=0.015). Ninety-four percent (179 of 191) of men completed the 6-mo, treatment-free period: Baseline sperm concentration levels were restored in 8 of 12 (tadalafil) and 1 of 2 (placebo) men. There were no significant differences between groups in secondary end points. Common treatment-emergent adverse events were headache, back pain, dyspepsia, gastroesophageal reflux disease, and myalgia. Twelve (9.6%) tadalafil and seven (5.5%) placebo subjects discontinued because of adverse events. CONCLUSIONS: This study demonstrated no deleterious effects of 9 mo of daily tadalafil 20mg on spermatogenesis or hormones related to testicular function in men >or= 45 yr.

Long-term safety and effectiveness of sildenafil citrate in men with erectile dysfunction.

Because sildenafil citrate is a treatment, not a cure, for erectile dysfunction (ED), many men may choose to use it for an extended period. Men with ED who had previously completed 1 of 4 double-blind trials with short-term open-label extension (combined duration, 0.9-1.2 years) were eligible for this 4-year, open-label, extension study, which assessed the safety and effectiveness of flexible doses (25, 50, and 100 mg sildenafil) used as needed. Adverse events that were serious or led to dosing changes or discontinuation (temporary or permanent) were recorded. Many of the 979 participants (mean age, 58 [range, 27-82] years; mean ED duration, 4.5 years) had concomitant hypertension (28%), diabetes (22%), or hyperlipidemia (14%). Overall, 37 (3.8%) had treatment-related adverse events (none serious) requiring dosage change or discontinuation and 62 (6.3%) discontinued because of insufficient response. At each yearly assessment, more than 94% of participants responded affirmatively to the questions: "Are you satisfied with the effect of treatment on your erections?" and "If yes, has treatment improved your ability to engage in sexual activity?" These results argue against the loss of tolerability or the development of tachyphylaxis over a prolonged period of as needed, flexible-dose sildenafil treatment of men with ED.

Early experience with the American Medical Systems new tactile pump: results of a multicenter study.

INTRODUCTION: A new Tactile Pump for the American Medical Systems (AMS) 700 Inflatable Penile Prosthesis (IPP) had been developed in an effort to improve usability for the patient. Aim. To assess the ease of use of the new Tactile Pump. METHODS: A prospective, multicenter study was conducted at four investigative sites. Preoperatively, patients completed an evaluation of the new Tactile Pump vs. the current design 700 pump placed in scrotal models. Patients compared the ease of inflation and deflation of each model. All patients were implanted with the AMS 700 IPP including the new Tactile Pump. Patients returned at 6 weeks for activation of the device and for follow-up evaluation at 3 and 6 months. MAIN OUTCOME MEASURES: Preoperatively patients compared ease of use of the Tactile Pump vs. the current design. Postoperatively both physicians and patients assessed device functionality for inflation and deflation, ease of use of the pump, and time required to learn device operation. RESULTS: Thirty patients were implanted with the AMS 700 IPP and Tactile Pump. Thirty patients completed an activation visit, 20 patients completed the 3-month evaluation, and 9 patients completed the 6-month evaluation. The average age was 62.1 years. Primary erectile dysfunction etiologies included organic, nonspecific 10 (33.3%), vasculogenic 6 (20.0%), prostatectomy 6 (20.0%), diabetes mellitus 4 (13.3%), Peyronie's disease 3 (10.0%), and spinal cord injury 1 (3.3%). Preoperatively 93.3% (P < 0.001) of patients favored the Tactile Pump over the current pump on locating and working the inflation mechanism in the scrotal model. Patients also found the Tactile Pump deflation mechanism easier to find 100% (P < 0.001) and deflate 96.7% (P < 0.001). Most patients (86.7%) were trained to use their devices within 3 minutes. CONCLUSIONS: The AMS Tactile Pump provides benefit to patients and physicians by improving ease of use and training over the current IPP 700 pump.