Sidell, Douglas R.

Background: Access to high-quality airway equipment is critical for effective otolaryngological and emergency care. In sub-Saharan Africa (SSA), challenges in the procurement infrastructure may hinder equipment availability, impacting patient outcomes. Given the paucity of literature investigating equipment procurement in SSA, this study aims to map out the multilevel barriers to procurement of airway equipment in SSA to inform opportunities for improvement. Methods: A qualitative study design was employed using semi-structured interviews and open-ended survey responses. Participants included otolaryngologists in SSA, manufacturing company representatives and international policymakers, selected through purposive sampling to ensure representation of various roles in the procurement process. Six interviews, one focus group and six survey responses with regional healthcare providers (n = 13), manufacturing representatives (n = 3) and international policymakers (n = 2) explored supply chain dynamics, regulatory challenges, manufacturing capabilities, financial constraints and policy frameworks. Data were analysed using thematic analysis to identify recurrent themes and interrelationships. Results: Systemic barriers exist in the procurement process, including fragmented supply chains, inconsistent regulatory enforcement, limited local manufacturing capacity and insufficient funding mechanisms. Otolaryngologists emphasised frequent delays in equipment availability, while manufacturers reported logistical challenges and regulatory hurdles. Policymakers noted gaps in infrastructure and regional coordination. Emerging themes suggest opportunities for streamlining procurement processes, fostering local production and enhancing collaboration to improve supply chain efficiency. Conclusion: This study underscores the multifaceted challenges in airway equipment procurement in SSA and highlights the need for integrated approaches involving stakeholders across the supply chain. Contribution: Findings provide actionable insights to inform policy development and capacity-building initiatives with the goal of enhancing access to life-saving airway equipment and improving healthcare outcomes.

Sub-Saharan Africa (SSA), home to over 1 billion people, has only one paediatric otolaryngology fellowship program and nine fellowship-trained paediatric Otolaryngology Head and Neck Surgery (OHNS) specialists covering seven countries. Seven of these specialists estimated an average of 40+ patients per month are in need of critical surgical airway management in their respective countries and that 2–25 deaths per year (mainly paediatric) occur in their country from lack of access to foreign body removal equipment. Investing in paediatric airway infrastructure and capacity would largely benefit the health system in SSA, where the current lack of equipment alone leads to unmeasured morbidity and mortality. As a region of the world with the largest paediatric populations, sub-Saharan Africa’s need is all the more pressing given the disproportionately low number of medical specialists, institutions and resources. Collaborative approaches in procurement and maintenance of high-quality, cost-effective equipment are crucially desirable factors in both low- and middle-income countries (LMICs) and high-income countries (HICs). We, as the Global OHNS Initiative, urge for multi-stakeholder engagement and collaboration to forge lasting change.

Objectives/HypothesisThis study defines essential data elements to be recorded during an aerodigestive “triple endoscopy” to form the foundation of a standardized multicenter registry and to clearly define measurement of each consensus item.Study DesignModified Delphi process.MethodsModified Delphi consensus with six survey rounds. Twenty‐four expert pediatric otolaryngology, pulmonology, and gastroenterology aerodigestive clinicians from eight large academic pediatric aerodigestive programs formed the Delphi panel. After achieving consensus through the Delphi process, outside validation was performed at 2019 national Aerodigestive Society conference. Consensus, near‐consensus, or exclusion was obtained for each proposed data element. Concordance was then measured between expert panel conclusions and validation group conclusions.ResultsOverall response rate was 94.4%. 73/167 proposed items reached consensus in six domains (flexible bronchoscopy, bronchoalveolar lavage, microdirect laryngoscopy and bronchoscopy, esophagogastroduodenoscopy with biopsies, and esophageal impedance and pH probe). Measurement of all items was defined; classification/grading systems were selected for 11 items. Validation group endorsed importance of 82/167 data items; compared to expert consensus, overall, inclusion, and exclusion concordance rates were 94.5%, 98.7%, and 90.9%.ConclusionTriple endoscopy is a central component of aerodigestive care. This study identifies and defines data elements to be recorded for all triple endoscopy procedures. The list is of usable length, and clear definitions were created for all items, with explicit classification/grading systems selected for 11 items. Face validity was confirmed with an independent multispecialty sample of aerodigestive providers. This consensus provides the foundation for a triple endoscopy registry but also is immediately applicable to standardize clinical documentation in aerodigestive care.Level of Evidence5 Laryngoscope, 132:2251–2258, 2022

Objectives/HypothesisThe 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 DesignDelphi method‐based survey series.MethodsA 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.ResultsThe 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).ConclusionThis 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 Evidence5 Laryngoscope, 131:E1941–E1949, 2021

ObjectiveThe mechanism by which recurrent croup occurs is unknown. Gastroesophageal reflux is commonly implicated, although this relationship is only loosely documented. We conducted a systematic review with a meta‐analysis component to evaluate the relationship between recurrent croup and gastroesophageal reflux disease (GERD), and to assess for evidence of improvement in croup symptoms when treated.Style DesignSystematic Review and Meta Analysis.MethodsWe searched five separate databases. Studies were included if they discussed the relationship between croup and GERD in children, >5 subjects, and available in English. Literature retrieved was assessed according to pre‐specified criteria. Retrieved articles were reviewed by two independent authors and decisions mediated by a third author. If there was a difference of opinion after first review, a second review was performed to obtain consensus. Heterogeneity was calculated and summarized in forest plots.ResultsOf 346 initial records, 15 met inclusion criteria. These were two retrospective cohort and 13 cross‐sectional studies. Thirteen of 15 articles support an association between recurrent croup and GERD. Although heterogeneity is high among studies that reported prevalence of GERD, there is less uncertainty in results for improvement to recurrent croup after GERD treatment. Most studies lacked a control group and all carry a moderate‐to‐high risk of bias.ConclusionThere is limited evidence linking GERD to recurrent croup; Further research is needed to assess for causality as most studies are retrospective, lack a control group, and have a study design exposing them to bias. Patients treated with reflux medication appear to demonstrate a reduced incidence of croup symptoms.Level of Evidence1 Laryngoscope, 131:209–217, 2021

Objectives/HypothesisCreate a competency‐based assessment tool for pediatric tracheotomy.Study DesignBlinded, modified, Delphi consensus process.MethodsUsing the REDCap database, a list of 31 potential items was circulated to 65 expert surgeons who perform pediatric tracheotomy. In the first round, items were rated as “keep” or “remove,” and comments were incorporated. In the second round, experts were asked to rate the importance of each item on a seven‐point Likert scale. Consensus criteria were determined a priori with a goal of 7 to 25 final items.ResultsThe first round achieved a response rate of 39/65 (60.0%), and returned questionnaires were 99.5% complete. All items were rated as “keep,” and 137 comments were incorporated. In the second round, 30 task‐specific and seven previously validated global rating items were distributed, and the response rate was 44/65 (67.7%), with returned questionnaires being 99.3% complete. Of the Task‐Specific Items, 13 reached consensus, 10 were near consensus, and 7 did not achieve consensus. For the 7 previously validated global rating items, 5 reached consensus and two were near consensus.ConclusionsIt is feasible to reach consensus on the important steps involved in pediatric tracheotomy using a modified Delphi consensus process. These items can now be considered to create a competency‐based assessment tool for pediatric tracheotomy. Such a tool will hopefully allow trainees to focus on the important aspects of this procedure and help teaching programs standardize how they evaluate trainees during this procedure.Level of Evidence5 Laryngoscope, 130:2700–2707, 2020

ObjectivesDevelop multidisciplinary and international consensus on patient, disease, procedural, and perioperative factors, as well as key outcome measures and complications, to be reported for pediatric airway reconstruction studies.MethodsStandard Delphi methods were applied. Participants proposed items in three categories: 1) patient/disease characteristics, 2) procedural/intraoperative/perioperative factors, and 3) outcome measures and complications. Both general and anatomic site‐specific measures were elicited. Participants also suggested specific operations to be encompassed by this project. We then used iterative ranking and review to develop consensus lists via a priori Delphi consensus criteria.ResultsThirty‐three pediatric airway experts from eight countries in North and South America, Europe, and Australia participated, representing otolaryngology (including International Pediatric Otolaryngology Group members), pulmonology, general surgery, and cardiothoracic surgery. Consensus led to inclusion of 19 operations comprising open expansion, resection, and slide procedures of the larynx, trachea, and bronchi as well as three endoscopic procedures. Consensus was achieved on multiple patient/comorbidity (10), disease/stenosis (7), perioperative‐/intraoperative‐/procedure‐related (16) factors. Consensus was reached on multiple outcome and complication measures, both general and site‐specific (8 general, 13 supraglottic, 15 glottic, 17 subglottic, 8 cervical tracheal, 12 thoracic tracheal). The group was able to clarify how each outcome should be measured, with specific instruments defined where applicable.ConclusionThis consensus statement provides a framework to communicate results consistently and reproducibly, facilitating meta‐analyses, quality improvement, transfer of information, and surgeon self‐assessment. It also clarifies expert opinion on which patient, disease, procedural, and outcome measures may be important to consider in any pediatric airway reconstruction patient.Level of Evidence5 Laryngoscope, 129:244–255, 2019

Objectives/HypothesisOver the past decade, thoracic slide tracheoplasty (TST) has become the principal operation in the management of congenital tracheal stenosis. The purpose of this report was to describe our experience with revision TST following unsuccessful prior tracheal reconstruction.Study DesignRetrospective analysis at an academic children's hospital.MethodsPatients undergoing TST on cardiopulmonary bypass between January 2005 and May 2014 were reviewed. Patients with a history of prior airway surgery were extracted for further analysis. Preoperative patient variables and postoperative outcomes were evaluated and compared between patients undergoing revision slide tracheoplasty (RTST) and a control group of 26 matched patients undergoing primary surgery TST.ResultsTwenty‐six revision patients (25 referrals, one primary patient) of 162 patients reviewed over the study period met inclusion criteria. Twenty‐three patients had a history of complete tracheal rings, and three patients had cartilaginous deficiency. A total of 41 airway reconstruction procedures had been performed prior to RTST. When compared to primary TST, patients undergoing RTST required fewer cardiac procedures intraoperatively, and fewer mean ventilator hours (P = .01) postoperatively. There was no significant difference in the median length of stay, requirement of >48 hours ventilation, or postoperative complications between groups. There was one nonsurgical postoperative mortality following RTST.ConclusionsDespite some differences in the postoperative management when compared to nonrevision cases, revision TST can be successfully performed after prior tracheal reconstruction with good postoperative outcomes.Level of Evidence4. Laryngoscope, 128:2181–2186, 2018

Objectives/HypothesisChildren with bilateral true vocal fold immobility (BTVFI) may present with significant airway distress necessitating tracheostomy. The objective of this study was to review our preliminary experience with the anterior–posterior cricoid split (APCS), an endoscopic intervention used as an alternative to tracheostomy in children with BTVFI.Study DesignMulticenter review.MethodsA review of patients undergoing endoscopic APCS for BTVFI at four institutions was performed. Patients were evaluated for the ability to ventilate without the requirement for tracheostomy or reintubation. Additional data extracted included the duration of intubation following APCS, the requirement for additional procedures, and demographics. Surgical success was defined as the ability to avoid tracheostomy and to cap or decannulate without respiratory symptoms if a tracheostomy was present prior to APCS.ResultsNineteen APCS procedures were performed between October 2010 and June 2016. There were 12 male patients, the mean age at APCS was 4.7 months. BTVFI was primarily idiopathic (58%) and associated with other comorbidities (74%). All patients were candidates for tracheostomy prior to APCS. Fourteen patients (74%) were considered surgical successes. Of the unsuccessful patients, three (66%) required tracheostomy following APCS, and one was treated with a posterior cartilage graft. There was one nonsurgical mortality greater than 2 months after APCS and thought to be unrelated to the airway.ConclusionsEndoscopic APCS appears to be a safe and effective intervention for pediatric BTVFI. Under the correct circumstances, this can be performed as a single procedure, obviating tracheostomy. Further study is warranted.Level of Evidence4. Laryngoscope, 128:257–263, 2018

ObjectiveTo develop general and site‐specific treatment effect and outcome measures to standardize the reporting of head and neck lymphatic malformation (HNLM) treatments.Study DesignConsensus statement/expert opinion.SettingMultiple tertiary academic institutions.Subjects and MethodsThe modified Delphi method is an iterative process of collecting expert opinions, refining opinions through discussion and feedback, statistically aggregating opinions, and using these aggregates to generate consensus opinion in the absence of other data. The modified Delphi method was used by a multi‐institutional group of otolaryngology and interventional radiology experts in the field of vascular anomalies to formulate a list of recommended reporting outcomes for the study and treatment of head and neck lymphatic malformations.ResultsThrough 3 rounds of iteration, 10 expert panelists refined 98 proposed outcome measures and 9 outcome categories to a final consensus set of 50 recommended outcome measures in 3 global categories (general, demographics, and treatment complications) and 5 site‐specific categories (orbit, oral cavity, pharynx, larynx, and neck).ConclusionsWe propose the first consensus set of standardized reporting measures for clinical and treatment outcomes in studies of HNLMs. Consistent outcome measures across future studies will facilitate comparison of treatment options and allow systematic review. We hope that these guidelines facilitate the design and reporting of subsequent HNLM studies.