Browsing by Author "Gold, Benjamin D."

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    Pooled Phase 2 and 3 Efficacy and Safety Data on Budesonide Oral Suspension in Adolescents with Eosinophilic Esophagitis
    (Wolters Kluwer, 2023) Mukkada, Vincent A.; Gupta, Sandeep K.; Gold, Benjamin D.; Dellon, Evan S.; Collins, Margaret H.; Katzka, David A.; Falk, Gary W.; Williams, James; Zhang, Wenwen; Boules, Mena; Hirano, Ikuo; Desai, Nirav K.; Pediatrics, School of Medicine
    Objectives: The objective of this study was to evaluate the efficacy and safety of budesonide oral suspension (BOS) in adolescents with eosinophilic esophagitis (EoE). Methods: This post hoc analysis pooled data from two 12-week, randomized, double-blind, placebo-controlled studies of BOS 2.0 mg twice daily (b.i.d.) (phase 2, NCT01642212; phase 3, NCT02605837) in patients aged 11-17 years with EoE and dysphagia. Efficacy endpoints included histologic (≤6, ≤1, and <15 eosinophils per high-power field [eos/hpf]), dysphagia symptom (≥30% reduction in Dysphagia Symptom Questionnaire [DSQ] scores from baseline), and clinicopathologic (≤6 eos/hpf and ≥30% reduction in DSQ scores from baseline) responses at week 12. Change from baseline to week 12 in peak eosinophil counts, DSQ scores, EoE Histology Scoring System (EoEHSS) grade (severity) and stage (extent) total score ratios (TSRs), and total EoE Endoscopic Reference Scores (EREFS) were assessed. Safety outcomes were also examined. Results: Overall, 76 adolescents were included (BOS, n = 45; placebo, n = 31). Significantly more patients who received BOS than placebo achieved histologic responses (≤6 eos/hpf: 46.7% vs 6.5%; ≤1 eos/hpf: 42.2% vs 0.0%; <15 eos/hpf: 53.3% vs 9.7%; P < 0.001) and a clinicopathologic response (31.1% vs 3.2%; P = 0.003) at week 12. More BOS-treated than placebo-treated patients achieved a dysphagia symptom response at week 12 (68.9% vs 58.1%; not statistically significant P = 0.314). BOS-treated patients had significantly greater reductions in EoEHSS grade and stage TSRs ( P < 0.001) and total EREFS ( P = 0.021) from baseline to week 12 than placebo-treated patients. BOS was well tolerated, with no clinically meaningful differences in adverse events versus placebo. Conclusions: BOS 2.0 mg b.i.d. significantly improved most efficacy outcomes in adolescents with EoE versus placebo.
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    Structure and Functions of Pediatric Aerodigestive Programs: A Consensus Statement
    (AAP, 2018-03) Boesch, R. Paul; Balakrishnan, Karthik; Acra, Sari; Benscoter, Dan T.; Cofer, Shelagh A.; Collaco, Joseph M.; Dahl, John P.; Daines, Cori L.; DeAlarcon, Alessandro; DeBoer, Emily M.; Deterding, Robin R.; Friedlander, Joel A.; Gold, Benjamin D.; Grothe, Rayna M.; Hart, Catherine K.; Kazachkov, Mikhail; Lefton-Greif, Maureen A.; Miller, Claire Kane; Moore, Paul E.; Pentiuk, Scott; Peterson-Carmichael, Stacey; Piccione, Joseph; Prager, Jeremy D.; Putnam, Philip E.; Rosen, Rachel; Rutter, Michael J.; Ryan, Matthew J.; Skinner, Margaret L.; Torres-Silva, Cherie; Wootten, Christopher T.; Zur, Karen B.; Cotton, Robin T.; Wood, Robert E.; Pediatrics, School of Medicine
    Aerodigestive programs provide coordinated interdisciplinary care to pediatric patients with complex congenital or acquired conditions affecting breathing, swallowing, and growth. Although there has been a proliferation of programs, as well as national meetings, interest groups and early research activity, there is, as of yet, no consensus definition of an aerodigestive patient, standardized structure, and functions of an aerodigestive program or a blueprint for research prioritization. The Delphi method was used by a multidisciplinary and multi-institutional panel of aerodigestive providers to obtain consensus on 4 broad content areas related to aerodigestive care: (1) definition of an aerodigestive patient, (2) essential construct and functions of an aerodigestive program, (3) identification of aerodigestive research priorities, and (4) evaluation and recognition of aerodigestive programs and future directions. After 3 iterations of survey, consensus was obtained by either a supermajority of 75% or stability in median ranking on 33 of 36 items. This included a standard definition of an aerodigestive patient, level of participation of specific pediatric disciplines in a program, essential components of the care cycle and functions of the program, feeding and swallowing assessment and therapy, procedural scope and volume, research priorities and outcome measures, certification, coding, and funding. We propose the first consensus definition of the aerodigestive care model with specific recommendations regarding associated personnel, infrastructure, research, and outcome measures. We hope that this may provide an initial framework to further standardize care, develop clinical guidelines, and improve outcomes for aerodigestive patients.