Clinical trials in otology: Examining trends and framework for prioritization.

OBJECTIVE: To characterize otologic clinical trials and examine otologic clinical trial trends from 2008 to 2018 using the clinicaltrials.gov database. METHODS: Data was collected from clinicaltrials.gov and included all clinical trials that focused on otology from 2008 to 2018. Outcome measures include status of trials, funding sources, details regarding otologic conditions studied, and trends in clinical trials. RESULTS: There were 992 otology clinical trials from 2008 to 2018.457 (46.1%) were completed and 94 (9.5%) were discontinued. Industry remained the highest (76.5%) contributor to otology clinical trials. The otologic conditions studied, from most common to least common, include hearing loss (40.6%), vestibulopathy (18.8%), tinnitus (18.8%), and otitis media (15.1%). The number of otology clinical trials increased by an average of 12.0 trials per year from 2008 to 2018 (p < 0.001). The number of otology clinical trials focusing on hearing loss and vestibulopathy significantly increased over the studied period (p < 0.001), while those focusing on tinnitus and otitis media did not (p = 0.09 and p = 0.20, respectively). The majority of clinical trials on each of these four conditions focused on treatment options. CONCLUSION: Our study describes trends in otology clinical trials registered on clinicaltrials.gov from 2008 through 2018. The total number of clinical trials over this time period increased significantly, driven by trials investigating hearing loss and vestibulopathy. Furthermore, most clinical trials were industry-sponsored and focused on treatment modalities. Our study provides an outline of otology clinical trials registered in a US web-based database, which may be of use for the development of future clinical trials.

The Utility of Assessing Liver Allograft Fibrosis and Steatosis Post-Liver Transplantation Using Transient Elastography With Controlled Attenuation Parameter.

AIM: Allograft steatosis is an emerging concern after liver transplantation (LT). The use of transient elastography (TE) with controlled attenuation parameter (CAP) may facilitate early detection of and intervention for allograft steatosis. This study aimed to evaluate the prevalence and risk factors of allograft steatosis using TE and CAP. METHODS: The presence of steatosis and severe steatosis were defined by CAP ≥222 and ≥290 dB/m, respectively. Demographics and clinical characteristics were compared between patients with and without severe steatosis. Regression analyses were performed to determine factors associated with severe steatosis. RESULTS: Of 150 patients, 105 (70%) had steatosis while 40% of these had severe steatosis. Thirty-four (81.0%) patients with severe steatosis had normal alanine transaminase at the time of TE. In multivariable analyses, age at LT (odds ratio [OR] 1.05, 95% confidence interval [CI] 1.01-1.08), post-LT obesity (OR 5.34, 95% CI 1.53-18.65), and alcoholic liver disease (OR 12.86, 95% CI 2.24-73.74) were significant predictors of severe steatosis. Five patients underwent liver biopsies as a result of advance fibrosis seen on TE and were later diagnosed with chronic allograft rejection. Two of these patients had normal liver chemistries, and the remaining 3 had mild elevation of alkaline phosphatase. CONCLUSION: Steatosis was present in 70% of patients who underwent TE after LT. Advanced age at LT, post-LT obesity, and alcoholic liver disease were significant predictors for severe steatosis. The majority of patients with severe steatosis had normal liver enzymes. TE should be considered as a screening modality for allograft steatosis and fibrosis even when liver chemistries are normal.

Non-research industry payments to pediatric otolaryngologists in 2018.

OBJECTIVES: To characterize non-research industry payments to pediatric otolaryngologists in 2018. STUDY DESIGN: Centers for Medicare and Medicaid Services Open Payments program was used to obtain all non-research industry payments to pediatric otolaryngology in 2018. Total payment amount information was obtained for years 2014-2017 for trend analysis. Descriptive statistics were used to analyze the data. RESULTS: There were 1704 payments to pediatric otolaryngologists in 2018, totaling $163,716 with a median of $17.79. Of the total payments, 74.77% (1274 out of 1704) were under $50. Payments to 299 physicians were reported for 175 different products, the majority of which were associated with otitis media and sinus disease. The nature of the payments included 1579 ($57,120) towards food and beverage, 64 ($46,251) for travel and lodging, 29 ($39,688) for consulting services, 23 ($1075) for education, 4 ($7898) for royalty or license, and 5 ($11,684) for compensation for services such as serving as faculty or a speaker. CONCLUSION: Our study is the first to investigate industry payments to pediatric otolaryngologists in 2018. Most of the payments were under $50 and mainly for food and beverage. The majority of payments were associated with otitis media and sinus disease.