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Microtia Reconstruction Practices Among Otolaryngologists in the United States
Winchester, Arianna; Santacatterina, Michele; Yang, Wenqing; Taufique, Zahrah; Eytan, Danielle F
OBJECTIVE:This study aims to describe current practices among otolaryngology-trained microtia surgeons in the United States. STUDY DESIGN/METHODS:Survey. SETTING/METHODS:A tertiary care center. METHODS:A 22-question anonymous digital survey of practice patterns and surgical methods was distributed to all members of the American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS) and the American Society of Pediatric Otolaryngology (ASPO). Responses were analyzed using descriptive statistics and linear regression models. RESULTS:Of 1730 eligible members, 83 (4.8%) responses were collected. Forty-three (51.8%) were AAFPRS members, 39 (47.0%) were ASPO members, and 1 (1.2%) reported dual membership. Respondents had multiple practice settings, were at different stages in their experience, and were well-distributed geographically. Forty (48.2%) don't perform microtia repair and half (52.5%) refer to an FPRS-trained colleague. Among microtia surgeons, most (N = 30, 69.8%) received fellowship training. Autologous reconstruction was the most popular method for training and practice; however, most perform multiple methods (N = 33, 76.7%). Autologous rib training was positively correlated with experience of >20 years. Those with combined autologous/alloplastic practice were more frequently trained by PO fellowship. Surgical site infection was the most frequent complication and was seen more often by those trained via residency alone (OR 12.8, P < .05). Those who trained in autologous rib alone were less likely to encounter postoperative graft exposure (OR 5.0, P < .05); however, they were more likely to encounter skin and soft tissue infection (OR 0.07, P < .05). CONCLUSION/CONCLUSIONS:Otolaryngology-trained microtia surgeons come from a variety of academic backgrounds and progress to varied practices. They are trained and practice both alloplastic and autologous repair methods, although autologous methods remain the most common.
PMID: 40226970
ISSN: 1097-6817
CID: 5827342
Identification and Estimation of Causal Effects Using Non-Concurrent Controls in Platform Trials
Santacatterina, Michele; Giron, Federico Macchiavelli; Zhang, Xinyi; Díaz, Iván
Platform trials are multi-arm designs that simultaneously evaluate multiple treatments for a single disease within the same overall trial structure. Unlike traditional randomized controlled trials, they allow treatment arms to enter and exit the trial at distinct times while maintaining a control arm throughout. This control arm comprises both concurrent controls, where participants are randomized concurrently to either the treatment or control arm, and non-concurrent controls, who enter the trial when the treatment arm under study is unavailable. While flexible, platform trials introduce the challenge of using non-concurrent controls, raising questions about estimating treatment effects. Specifically, which estimands should be targeted? Under what assumptions can these estimands be identified and estimated? Are there any efficiency gains? In this article, we discuss issues related to the identification and estimation assumptions of common choices of estimand. We conclude that the most robust strategy to increase efficiency without imposing unwarranted assumptions is to target the concurrent average treatment effect (cATE), the ATE among only concurrent units, using a covariate-adjusted doubly robust estimator. Our studies suggest that, for the purpose of obtaining efficiency gains, collecting important prognostic variables is more important than relying on non-concurrent controls. We also discuss the perils of targeting ATE due to an untestable extrapolation assumption that will often be invalid. We provide simulations illustrating our points and an application to the ACTT platform trial, resulting in a 20% improvement in precision compared to the naive estimator that ignores non-concurrent controls and prognostic variables.
PMID: 40095648
ISSN: 1097-0258
CID: 5813092
Acute Effects of Steroids on Vocal Fold Epithelium Post-injury in a Preclinical Model
Gartling, Gary; Sayce, Lea; Zimmerman, Zachary; Slater, Alysha; Hary, Lizzie; Yang, Wenqing; Santacatterina, Michele; Rousseau, Bernard; Branski, Ryan C
INTRODUCTION/BACKGROUND:Glucocorticoids (GCs) are commonly prescribed for laryngeal indications due to their potent anti-inflammatory properties. However, GCs effect on vocal fold (VF) epithelial morphology and barrier function following injury is overlooked and may be key to efficacy. In this study, the effects of GCs on epithelial morphology and barrier function were quantified in injured VFs. We seek to increase our understanding of biochemical processes underlying GC mechanisms to refine therapeutic strategies. METHODS:Microflap injury was induced in 65 rabbits. Seven days after injury, animals received bilateral 20 μL intracordal injections of saline, dexamethasone, methylprednisolone, or triamcinolone (n = 15 per condition). Five rabbits in each condition were euthanized 1, 7, or 60 days following treatment. An additional five animals served as non-injured/untreated controls. To quantify transepithelial electrical resistance (TEER), 1 mm epithelial biopsies were placed in an Ussing chamber. The contralateral VF was processed for transmission electron microscopy and epithelial depth analysis. RESULTS:At 60 days, GC treatment maintained TEER levels similar to non-injured/untreated controls. However, triamcinolone reduced TEER compared with saline-treated conditions. Acutely, epithelial hyperplasia typically persisted in all injured VFs. At 60 days, only dexamethasone and triamcinolone increased epithelial depth in injured VFs; all GCs increased epithelial depth compared with non-injured/untreated controls. CONCLUSION/CONCLUSIONS:Acutely, GCs did not alter TEER. Additionally, GCs did not alter epithelial depth compared with saline treatment, indicating alignment with natural healing responses. At 60 days, GCs exhibited varying degrees of TEER restoration and epithelial hyperplasia, possibly due to distinct pharmacodynamic profiles. LEVEL OF EVIDENCE/METHODS:NA Laryngoscope, 2024.
PMID: 39276031
ISSN: 1531-4995
CID: 5690922
Study protocol for a randomized controlled trial to adapt a posttraumatic stress disorder intervention of patients with opioid-stimulant polysubstance use receiving methadone maintenance treatment
Renn, Tanya; Griffin, Brittany; Kumaravelu, Vinodini; Ventuneac, Ana; Santacatterina, Michele; Bunting, Amanda M
BACKGROUND:The purpose of the Treatment for Harnessing Resiliency, Improving emotional regulation, and empowering indiViduals for a brighter future (THRIVE) study is to adapt an evidence-based posttraumatic stress disorder (PTSD) treatment for use among a polysubstance population receiving methadone maintenance treatment (MMT) at an opioid treatment program. Polysubstance use of high-risk combinations, such as illicit opioids and stimulants, is a critical public health issue. Individuals who engage in these high-risk combinations are more likely to have histories of childhood trauma, multiple traumas, PTSD, and greater PTSD severity as compared to mono-substance using individuals. Trauma, co-morbid mental health disorders such as PTSD, and polysubstance use complicate treatment outcomes. This study will use eight study phases to adapt an existing evidence-based PTSD intervention, Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT), via a massed treatment model (i.e., condensed treatment schedule) for patients in MMT who are engaged in sustained opioid-stimulant polysubstance use. METHODS AND ANALYSIS/METHODS:The intervention is an adapted version of the STAIR-NT protocol. The massed version created includes four 60-min sessions of skill building and two weeks of four 60-min sessions of narrative therapy. A preliminary randomized controlled trial (RCT) with 80 participants, randomized 1:1, will be conducted to assess the intervention's implementation and impact on primary short-term outcomes of polysubstance use and PTSD symptoms. ETHICS AND DISSEMINATION/BACKGROUND:The results of this study will inform a fully-powered effectiveness trial for individuals with PTSD and polysubstance use receiving MMT. The findings are expected to provide valuable insights into improving both PTSD and substance use outcomes, and real-world implementation insights to integrating trauma-informed care in treatment settings for vulnerable populations. REGISTRATION/BACKGROUND:This study is registered at ClinicalTrials.Gov as NCT06307340. Registration date 03/2024.
PMCID:11616292
PMID: 39627789
ISSN: 1471-244x
CID: 5763792
Reducing Length of Stay in Reconstructive Head and Neck Surgery Patients: A Quality Improvement Initiative
Bhatt, Nupur; Yang, Jackie; DeBaere, Lauren; Wang, Ronald Shen; Most, Allison; Zhang, Yan; Dayanov, Elan; Yang, Wenqing; Santacatterina, Michele; Kamberi, Maria; Mojica, Jacqueline; Kamen, Emily; Savitski, Justin; Stein, John; Jacobson, Adam
OBJECTIVE:To investigate whether a new preoperative education and discharge planning protocol reduced unexpected discharge delays for patients undergoing reconstructive surgery for head and neck cancer. METHODS:A quality improvement (QI) intervention was implemented in January 2021 with several components to address historically prolonged observed lengths of stay (LOS) with head and neck cancer patients. The intervention added a preoperative educational visit with a head and neck cancer advanced practice provider, a standardized preoperative speech and swallow assessment, a personalized patient care plan document, discussion of inpatient hospital stay expectations, and early discharge planning. The intervention group included patients who underwent the preoperative education protocol from February to December 2021. For comparison, an age and sex-matched control group was constructed from inpatients who had been admitted for similar procedures in the 2 years prior to the QI intervention (2019-2020) and received standard of care counseling. RESULTS:Our study demonstrated a significant reduction in observed to expected LOS ratio after implementation of the intervention (1.24 ± 0.74 control, 0.95 ± 0.52 intervention; P = .012). DISCUSSION/CONCLUSIONS:We discuss a preoperative education QI intervention at our institution. Our findings demonstrate that our intervention was associated with decreased LOS for patients undergoing head and neck reconstructive surgeries. IMPLICATIONS FOR PRACTICE/CONCLUSIONS:This QI study shows the benefit of a new standardized preoperative education and discharge planning protocol for patients undergoing head and neck reconstructive surgeries.
PMID: 39118499
ISSN: 1097-6817
CID: 5730902
Patient Characteristics Impacting Adherence to Serial Observation for Vestibular Schwannomas
Wang, Ronald S; Asfour, Leena; Yang, Wenqing; Zhang, Yan; Santacatterina, Michele; Jethanamest, Daniel
OBJECTIVE:To examine patient characteristics that impact serial observation adherence among vestibular schwannoma (VS) patients. STUDY DESIGN/METHODS:Retrospective chart review. SETTING/METHODS:Single tertiary care center. METHODS:We selected for VS patients from 201 to 2020 who elected for serial observation as initial management. Patients under 18, with previous management, bilateral or intralabyrinthine VS, and neurofibromatosis type 2 were excluded. Demographics, tumor characteristics, and follow-up status were extracted. Single and multiple logistic regression was used to identify patient characteristics impacting follow-up. RESULTS:We identified 507 VS patients who chose serial observation as initial management. Most were female (56.0%), white (73.0%), and married (72.8%). The mean age was 59.3 and most had private insurance (56.4%). Median Charlson Comorbidity Index was 2.00. Mean pure tone audiometry (PTA) average was 41.7 Hz. Average tumor size was 9.04 mm. Of 507 patients, 358 (70.6%) returned for at least one follow-up. On multiple logistic regression analysis, patients with private insurance (odds ratio [OR]: 0.39, confidence interval [CI]: 0.22-0.68; P = .001), racial minority background (OR: 0.54, CI: 0.35-0.83; P = .005), worse PTA averages (OR: 0.99, CI: 0.98-1.00; P = .044), and older age at diagnosis (OR: 0.97, CI: 0.95-1.00; P = .038) were less likely to follow-up. CONCLUSION/CONCLUSIONS:Private health insurance, racial minority background, worse PTA average, and older age were associated with decreased follow-up among adult VS patients electing serial observation. Patients with these characteristics may require additional support to ensure serial observation adherence.
PMID: 38520200
ISSN: 1097-6817
CID: 5641062
Comparison of four ventilation tubes commonly used in the pediatric population: A retrospective cohort study
Morrissette, Margareta; Ben-Dov, Tom; Santacatterina, Michele; Catháin, Éadaoin Ó; April, Max M
OBJECTIVE/UNASSIGNED:To assess differences in otorrhea, tympanic membrane perforation, and time to extrusion in children receiving one of four commonly used, short-term ventilation tubes for the first time. METHODS/UNASSIGNED:Retrospective chart review of 2 years of postoperative follow-up to analyze patient outcomes after insertion of either a Paparella type-I Activent, Armstrong Beveled, Modified Armstrong, or Armstrong Microgel ventilation tube. Incidence of complications was determined by reviewing provider notes. Adjusted multivariate logistic regression models were used to determine odds ratios of complications among the four tube types. RESULTS/UNASSIGNED:A total of 387 patients were reviewed. The mean age was 2.4 years and 35.9% were female. Armstrong beveled tubes had the highest odds of otorrhea. Paparella type-I tube had the shortest time to extrusion of about 9 months, while Armstrong Beveled had the longest, at almost 19 months. When evaluating episodes of otorrhea each child experienced on average, per month, Armstrong beveled tubes had the highest monthly rate of otorrhea and Paparella type-I the least. No significant differences were found regarding tympanic membrane perforation. CONCLUSIONS/UNASSIGNED:This retrospective chart review showed that no tube was clinically superior across all complications. The findings from this study may give otolaryngologists an opportunity to consider choosing a specific type of tube according to the clinical situation. The large variations in extrusion times should be considered in terms of patient age, seasonality, and desired duration of tube placement. LEVEL OF EVIDENCE/UNASSIGNED:4.
PMCID:11283280
PMID: 39071206
ISSN: 2378-8038
CID: 5731262
Anti-spike antibody responses to SARS-CoV-2 mRNA vaccines in people with schizophrenia and schizoaffective disorder
Nemani, Katlyn; De Picker, Livia; Dickerson, Faith; Leboyer, Marion; Santacatterina, Michele; Ando, Fumika; Capichioni, Gillian; Smith, Thomas E; Kammer, Jamie; El Abdellati, Kawtar; Morrens, Manuel; Coppens, Violette; Katsafanas, Emily; Origoni, Andrea; Khan, Sabahat; Rowe, Kelly; Ziemann, R Sarah; Tamouza, Ryad; Yolken, Robert H; Goff, Donald C
IMPORTANCE/UNASSIGNED:Individuals with schizophrenia are at higher risk for severe COVID-19 illness and severe breakthrough infection following vaccination. It is unclear whether immune response to vaccination differs in this population. OBJECTIVE/UNASSIGNED:To assess whether anti-SARS-CoV-2 spike antibody titers after vaccination differ in people with a diagnosis of schizophrenia or schizoaffective disorder (SZ) compared to controls without a psychiatric disorder. DESIGN/UNASSIGNED:This cohort study assessed antibody response following the first and second dose of mRNA vaccines at longitudinal timepoints, up to 7 weeks following the first dose of vaccine. SETTING/UNASSIGNED:A multi-center study including psychiatric healthcare settings in the United States and Europe. PARTICIPANTS/UNASSIGNED:205 adults with no history of COVID-19 infection, including 106 individuals with SZ and 99 controls without a psychiatric disorder, who received their first dose of SARS-CoV-2 mRNA vaccine between December 20, 2020 and May 27, 2021. MAIN OUTCOMES AND MEASURES/UNASSIGNED:Mean SARS-CoV-2 anti-Spike IgG antibody levels within 7 weeks after the first dose of vaccination. RESULTS/UNASSIGNED: = 0.96). CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this cohort study of individuals with SZ and a control group without psychiatric disorders, SZ was associated with lower SARS-CoV-2 anti-spike antibody levels following 2 doses of SARS-CoV-2 mRNA vaccination. This highlights the need for further studies assessing vaccine immunogenicity in individuals with schizophrenia.
PMCID:11252076
PMID: 39021438
ISSN: 2666-3546
CID: 5731932
Clinical prediction for surgical versus nonsurgical interventions in patients with vertebral osteomyelitis and discitis
Lee, Jennifer; Ruiz-Cardozo, Miguel A; Patel, Rujvee P; Javeed, Saad; Lavadi, Raj Swaroop; Newsom-Stewart, Catherine; Alyakin, Anton; Molina, Camilo A; Agarwal, Nitin; Ray, Wilson Z; Santacatterina, Michele; Pennicooke, Brenton H
BACKGROUND/UNASSIGNED:Vertebral osteomyelitis and discitis (VOD), an infection of intervertebral discs, often requires spine surgical intervention and timely management to prevent adverse outcomes. Our study aims to develop a machine learning (ML) model to predict the indication for surgical intervention (during the same hospital stay) versus nonsurgical management in patients with VOD. METHODS/UNASSIGNED:This retrospective study included adult patients (≥18 years) with VOD (ICD-10 diagnosis codes M46.2,3,4,5) treated at a single institution between 01/01/2015 and 12/31/2019. The primary outcome studied was surgery. Candidate predictors were age, sex, race, Elixhauser comorbidity index, first-recorded lab values, first-recorded vital signs, and admit diagnosis. After splitting the dataset, XGBoost, logistic regression, and K-neighbor classifier algorithms were trained and tested for model development. RESULTS/UNASSIGNED:), admit diagnosis of intraspinal abscess and granuloma, admit diagnosis of sepsis, race, troponin I, acid-fast bacillus culture, and alveolar-arterial gradient (A-a gradient). XGBoost model metrics were as follows: accuracy =0.7534, sensitivity =0.7436, specificity =0.7586, and area under the curve (AUC) =0.8210. CONCLUSIONS/UNASSIGNED:The XGBoost model reliably predicts the indication for surgical intervention based on several readily available patient demographic information and clinical features. The interpretability of a supervised ML model provides robust insight into patient outcomes. Furthermore, it paves the way for the development of an efficient hospital resource allocation instrument, designed to guide clinical suggestions.
PMCID:11224782
PMID: 38974494
ISSN: 2414-469x
CID: 5732222
Adjuvant Radiotherapy in Moderately Advanced (T3) Oral Cavity Cancers
Wang, Ronald S; Chow, Michael S; Gordon, Alex J; Santacatterina, Michele; Vaezi, Alec E; Tam, Moses M; Givi, Babak
OBJECTIVE:To investigate the impact of adjuvant radiotherapy in isolated locally advanced oral cavity cancers (pT3N0M0) without adverse features. METHODS:We selected all patients from the National Cancer Database (2004-2019) who underwent surgical treatment where the final pathology was T3N0M0 with negative margins. Demographics, details of treatment, and outcomes were abstracted. The impact of radiotherapy on survival was assessed with univariable, multivariable, and propensity score-matched analyses. RESULTS:We identified 571 patients in our survival cohort. Most were male (348, 60.9%), and median age was 65. Less than one-third (176, 30.8%) received adjuvant radiotherapy. The median length of follow-up was 29 months. Overall, adjuvant radiotherapy was associated with improved survival (87.2% vs. 77.7%, at 2 years, p < 0.01). On multivariable analysis controlling for age and comorbidities, this survival difference persisted (HR: 0.62, 95% CI: 0.43-0.90, p = 0.01). In a propensity score-matched population of 278 patients matched on age and comorbidities, adjuvant radiotherapy was still associated with longer survival (87.4% vs. 78.5%, p = 0.014). CONCLUSION/CONCLUSIONS:In our study, adjuvant radiotherapy was associated with improved survival in completely excised locally advanced oral cavity tumors (T3N0M0). However, a significant proportion of patients do not receive adjuvant radiotherapy. These findings highlight the need for continued efforts to promote guideline-recommended care. LEVEL OF EVIDENCE/METHODS:3 Laryngoscope, 134:2236-2242, 2024.
PMID: 37937735
ISSN: 1531-4995
CID: 5725482