Review of Pediatric Otolaryngology Clinical Trials: Past Trends and Future Opportunities.

OBJECTIVES/HYPOTHESIS: Pediatric otolaryngologic conditions are highly prevalent in the United States. Although data gathered from clinical trials drive therapeutic strategies, the trends of research in pediatric otolaryngology remain unclear. The objective of this study was to characterize recent trials in pediatric otolaryngology to better understand current directions of study and to identify opportunities for future research. STUDY DESIGN: Retrospective analysis. METHODS: A retrospective analysis of United States pediatric clinical trials in otolaryngology between 2001 and 2017 was conducted on ClinicalTrials.gov. Criteria for inclusion included otolaryngologic trials with at least one trial arm of participants <18 years of age, interventional design that was closed, and conducted in the United States. We assessed the information available to us on ClinicalTrials.gov to identify recent trends in pediatric otolaryngology interventional research. We used PubMed to examine publication rates and National Institutes of Health RePORTER to characterize funding patterns for these trials. RESULTS: Of the 122 trials analyzed, 25% investigated treatments for rhinitis, 25% for acute otitis media, and 50% for all other conditions. Drug studies comprised 72% of all trials. Overall, 65% had their results published in a peer-reviewed journal. Industry funding accounted for 73% of financial support. CONCLUSIONS: Continued focus on the development of pediatric otolaryngologic clinical trials allows an opportunity to better represent the wide spectrum of disease and therapy in the specialty. Increasing the rates of results publication and federal funding may spearhead a more balanced landscape of clinical trials and further advance the care of children with otolaryngologic disease. LEVEL OF EVIDENCE: NA Laryngoscope, 130:2719-2724, 2020.

Clinical scribes and their association with patient experience in the otolaryngology clinic.

OBJECTIVES/HYPOTHESIS: Electronic health records have brought many advantages but also placed a documentation burden on the provider during and after the clinic visit. Some otolaryngologists have countered this challenge by employing clinical scribes. This project aimed to better understand the influence of scribes on patient experience in the otolaryngology clinic. STUDY DESIGN: Retrospective cohort survey study. METHODS: Patients presenting to the otolaryngology clinic for new and follow-up appointments were recruited to complete surveys about their experience. RESULTS: A total of 153 patients completed the survey, and 96 of those patients (62.7%) interacted with a scribe. Patient satisfaction was not significantly associated with participation of the scribe (P = .668). Similarly, patient rating of their physician on a scale of 1 to 10 was not associated with scribe involvement (P = .851). The patients who did interact with a scribe responded that the scribe positively impacted the visit 77.1% of the time. Participation of a resident, primary language other than English, and use of interpreter were associated with lower satisfaction (P = .004, P < .001, and P < .001, respectively). CONCLUSIONS: There are no published data on the effect of scribes on patient experience in the otolaryngology clinic. In other specialties, scribes have been demonstrated as having a positive effect on provider satisfaction, clinical productivity, and patient perception. These data demonstrate that patient satisfaction was neither impaired nor improved by the presence of the scribe in this clinic. In light of benefits demonstrated by prior studies, these findings support the conclusion that scribes are a useful adjunct in providing high-level otolaryngology care. LEVEL OF EVIDENCE: 4 Laryngoscope, 130:E134-E139, 2020.

Inferior Turbinate Hypertrophy: A Review of the Evolution of Management in Children.

BACKGROUND: Historically, there has been uncertainty in the treatment of inferior turbinate hypertrophy (ITH) in children. Although management always begins with medical therapy, the decision to offer surgery in resistant cases is becoming more widely practiced. In the pediatric population, turbinate reduction can be achieved with turbinectomy, electrocautery, lasers, submucous microdebridement, and radiofrequency volumetric tissue reduction (RVTR). However, there remains a lack of consensus on the preferred approach to treatment. OBJECTIVE: To compare how the efficacy, duration, and complications of different surgical methods has changed the management of inferior turbinate hypertrophy in children over time. METHODS: In March 2018, a comprehensive literature search was performed in PubMed for all inferior turbinate hypertrophy management-related studies in children. Inclusion criteria included children (age, 1-17 years). Exclusion criteria included reviews and abstracts. RESULTS: Each technique has experienced a period of popularity over the last 30 years in parallel with the technology available at the time as well as evidence from studies in adults. The literature for ITH management in children has largely followed these trends, with a recent improvement in the quality of studies mirroring the overall increase in surgical practice. Of all methods currently used, RVTR and submucous microdebridement offer the least invasive and most efficacious relief of nasal obstruction. CONCLUSION: This review provides an overview of the evolution of ITH management in children and, based on historic and current evidence, proposes the following graduated recommendation to treatment: (1) a 3-month trial of medical management, (2) evaluation for adenoid hypertrophy for consideration of concurrent adenoidectomy, and (3) RVTR or submucous microdebridement as the first-line surgical approach.

Infrainguinal open reconstruction: a review of surgical considerations and expected outcomes.

Infrainguinal arterial occlusive disease can lead to potentially disabling and limb-threatening conditions. Revascularization may be indicated for claudication, rest pain, or tissue loss. Although endovascular interventions are becoming more prevalent, open surgeries such as endarterectomy and bypass are still needed and performed regularly. Open reconstruction has been associated with postoperative morbidity, both at the local and at the systemic levels. Local complications include surgical site infections (SSIs 0-5.3%), graft failure (12-60%), and amputation (5.7-27%), and more systemic issues include cardiac (2.6-18.4%), respiratory (2.5%), renal (4%), neurovascular (1.5%), and thromboembolic (0.2-1%) complications. While such outcomes present an additional challenge to the postoperative management of surgical patients, it may be possible to minimize their occurrence through careful risk stratification and preoperative assessment. Therefore, individualized selection of candidates for open repair requires weighing the need for intervention against the likelihood of adverse outcomes based on preoperative risk factors. This review provides an overview of open reconstruction, focusing on identifying the clinical indications for surgery and perioperative morbidity and mortality.