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OBJECTIVES: To provide a clinical disease state review of recent relevant literature and to generate expert consensus statements regarding the breadth of pediatric thyroid cancer diagnosis and care, with an emphasis on thyroid surgery. To generate expert statements to educate pediatric practitioners on the state-of-the-art practices and the value of surgical experience in the management of this unusual and challenging disease in children. METHODS: A literature search was conducted and statements were constructed and subjected to a modified Delphi process to measure the consensus of the expert author panel. The wording of statements, voting tabulation, and statistical analysis were overseen by a Delphi expert (J.J.S.). RESULTS: Twenty-five consensus statements were created and subjected to a modified Delphi analysis to measure the strength of consensus of the expert author panel. All statements reached a level of consensus, and the majority of statements reached the highest level of consensus. CONCLUSION: Pediatric thyroid cancer has many unique nuances, such as bulky cervical adenopathy on presentation, an increased incidence of diffuse sclerosing variant, and a longer potential lifespan to endure potential complications from treatment. Complications can be a burden to parents and patients alike. We suggest that optimal outcomes and decreased morbidity will come from the use of advanced imaging, diagnostic testing, and neural monitoring of patients treated at high-volume centers by high-volume surgeons.
Subject(s)
Endocrinology , Thyroid Neoplasms , Child , Consensus , Diagnostic Imaging , Humans , Thyroid Neoplasms/surgery , United StatesABSTRACT
PURPOSE OF REVIEW: To examine the role of allergy medications in the treatment of otitis media with effusion (OME), focusing on use of intranasal steroids and antihistamines. RECENT FINDINGS: There has been ongoing controversy regarding the role of allergy in the development of OME. Treatment of OME with medications commonly used for allergic symptomatology has been studied. Proposed treatment options include decongestants, mucolytics, oral steroids, topical steroids, antihistamines, and antibiotics. We begin by evaluating the proposed association between allergy and OME, and then evaluate intranasal steroids and oral antihistamine therapy in the treatment of OME. The role of the adenoid and concurrent nasal symptomatology is also addressed. The preponderance of data suggests that neither intranasal steroids nor antihistamines improve the long-term clearance of isolated OME and are therefore not recommended. However, data are notably limited with regard to improvement rates in OME in patients specifically with concurrent allergy and/or adenoid hypertrophy. Future studies of medications for OME would ideally incorporate study designs controlling for both allergic rhinitis and adenoid hypertrophy, to better understand the impact of these medications on OME in these subgroups of patients.
Subject(s)
Administration, Intranasal/methods , Histamine Antagonists/therapeutic use , Otitis Media with Effusion/therapy , Steroids/therapeutic use , Histamine Antagonists/pharmacology , Humans , Steroids/physiologyABSTRACT
PURPOSE OF REVIEW: To examine the relationship between otitis media, allergic rhinitis, and age. RECENT FINDINGS: Otitis media and allergic rhinitis are prevalent conditions with a controversial relationship. Some data suggest that these entities are significantly associated, either through allergic rhinitis inducing Eustachian tube dysfunction or through allergic pathophysiology simultaneously occurring intranasally and in the ear. Other studies, however, have refuted this relationship. For example, treatment with antihistamines does not reliably improve OME, making causation and association challenging to establish. Age may have an effect on the nature of the relationship between allergic rhinitis and otitis media, by impacting both the individual conditions and their association. Epidemiological, immunological, and adenoidal studies have suggested that differences occur with age, and this review encapsulates the related data and publications. We begin by evaluating how allergic rhinitis and otitis media each are affected by age, then evaluate the role that age may have in the relationship between the two conditions. Adult and pediatric literature are evaluated so as to include the full impact of age across patients' lifespan. Age induces changes in immunity, patterns of inflammation, and susceptibility to both allergic rhinitis and otitis media with effusion. Age may also be an effect modifier which impacts the nature of the relationship between these two conditions. The influence of age on the association between these highly prevalent conditions remains a topic of active study.
Subject(s)
Otitis Media/epidemiology , Rhinitis, Allergic/epidemiology , Adenoids , Age Factors , Eosinophilia/epidemiology , Eosinophilia/immunology , Humans , Immune System , Mucins , Otitis Media/immunology , Rhinitis, Allergic/immunologyABSTRACT
OBJECTIVES: To develop and assess the validity of a novel allergy-specific domain for the 22-item sino-nasal outcomes test (SNOT-22), to provide a new tool that efficiently quantifies the impact of allergic rhinitis (AR) concurrent with chronic rhinosinusitis. STUDY DESIGN: Prospective validation study. SETTING: Tertiary care hospital and community-based clinic. METHODS: Proposed items were developed based on clinician and patient input, and further assessed via factor analysis and for internal consistency (n = 1987). Items were then additionally assessed for convergent and discriminant validity (n = 415), applying data from concurrent completions of the Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE), Mini-Rhinoconjunctivitis Quality-of-Life Questionnaire (MiniRQLQ), and validated global health assessments. Assessments of intra-rater reliability, responsiveness to change, and qualitative input were also performed. RESULTS: Factor analysis demonstrated that proposed allergy items mapped to a single domain. Items were internally consistent (Cronbach α: 0.80 within domain, 0.91 within all SNOT). In assessments of convergent validity, domain scores were associated with MiniRQLQ (Spearman's ρ: 0.46, 95% confidence interval [CI]: 0.30-0.59) and NOSE scores (0.36, 95% CI: 0.27-0.44). The novel items also discriminated among clinical states: a 1-point increase in domain score was associated with an 8.32 (95% CI: 5.43-12.75) increase in the odds of prompting a visit for allergy-related symptoms and a 1.52 (95% CI: 1.13-2.05) increase in the odds of positive allergy testing. Intra-rater reliability was substantial (Cohen's κ: 0.8, 95% CI: 0.8-0.9), and responsiveness to change was demonstrated (mean difference: -0.6, 95% CI: -0.8 to -0.4). CONCLUSIONS: This novel domain is a valid, efficient measure of AR alongside rhinosinusitis.
Subject(s)
Nasal Obstruction , Rhinitis, Allergic , Rhinitis , Sinusitis , Humans , Rhinitis/diagnosis , Rhinitis/surgery , Reproducibility of Results , Sinusitis/diagnosis , Sinusitis/surgery , Quality of Life , Rhinitis, Allergic/diagnosis , Surveys and Questionnaires , Chronic DiseaseABSTRACT
Importance: Although patient-reported outcomes provide valuable insights, these subjective data may not align with objective test results. Hearing loss is a pervasive problem, such that concordance between subjective perceptions of hearing ability and objective audiogram assessments would be beneficial. Objectives: To determine (1) whether psychological status is an effect modifier of the association between subjective patient reports of hearing ability and objective audiometry results, and (2) whether any effect modification observed in standard static questionnaires would be either mitigated or exacerbated by adaptive testing based on Item Response Theory analyses. Design, Setting, and Participants: This diagnostic study at a tertiary care center and community-based practice included consecutive adults who presented with queries related to hearing loss. Participants were recruited and enrolled and data analyses occurred from 2022 to 2024. Exposures: Participants prospectively reported their hearing-specific abilities through either a standard static or adaptive version of the Inner Effectiveness of Auditory Rehabilitation (EAR) scale, alongside validated measures of their mental health and audiometry. Word recognition scores (WRS) and pure tone averages (PTA) were used to analyze audiometric testing. Main Outcomes and Measures: The association between subjective Inner EAR results and audiometry was evaluated. Stratified analyses were used to assess for effect modification by psychological status. The results of standard static and adaptive testing were compared. Results: In this study of 395 patients (mean [range] age, 55.9 [18-89] years; 210 [53.2%] female), standard static Inner EAR mean scores were appropriately higher in patients with higher (better) WRS (50.7, 95% CI, 46.4-54.9), compared with patients with lower (worse) WRS (34.7, 95% CI, 24.3-45.1). However, among patients with worse mental health, there was no association between standard static Inner EAR scores and WRS. In contrast, adaptive Inner EAR mean scores were significantly higher for those with better WRS, regardless of mental health status. Thus, effect modification was observed in standard static assessments, whereas adaptive testing remained durably associated with audiometry, regardless of mental health. Conclusions and Relevance: Psychological status was an effect modifier of the association between standard Inner EAR scale scores and audiometry, with a positive association observed only in those with better mental health. Adaptive testing scores, however, remained significantly associated with audiometry, even when mental status was worse. Adaptive testing may stabilize the association between subjective and objective hearing outcomes.
Subject(s)
Hearing Loss , Humans , Female , Male , Middle Aged , Hearing Loss/psychology , Aged , Audiometry, Pure-Tone , Adult , Patient Reported Outcome Measures , Prospective Studies , Surveys and Questionnaires , Audiometry , Mental HealthABSTRACT
OBJECTIVE: Patient-reported outcome measures, while valuable, may not correlate with diagnostic test results. To better understand this potential discrepancy, our objective was to determine whether psychological health is an effect modifier of the association between patient-reported allergy outcome scores and allergy test results. STUDY DESIGN: Prospective outcomes study. SETTING: Tertiary care hospital and community-based clinic. METHODS: This study included 600 patients at least 18 years of age who presented for symptoms related to allergic rhinitis and completed the related sinonasal outcome test (SNOT), which includes validated nasal, allergy, and psychological domains. Stratified analyses of odds ratios and Spearman correlation coefficients were utilized to assess for effect modification by psychological status. RESULTS: Worse patient-reported allergic rhinitis symptoms were significantly associated with positive allergy test results (odds ratio [OR] 1.69, 95% confidence interval [CI] 1.22-2.34, P = .002) in patients with better psychological health. In contrast, there was no association in patients with worse psychological health (OR 1.06, 95% CI 0.36-3.10, P = .92). These findings were corroborated by assessments of correlation: allergy domain scores were positively correlated with allergy testing scores (Spearman rho 0.18, 95% CI 0.10-0.25, P < .001) in patients with better psychological health, while there was no correlation in patients with worse psychological health (-0.02, 95% CI -0.16-0.12, P = .77). CONCLUSIONS: Psychological status was an effect modifier of the association between allergy domain and allergy testing data. When assessing the relationship between subjective measures, such as sinonasal validated instruments, and objective measures, such as allergy test results, accounting for effect modifiers such as psychological state can provide clinical and research-related insights.
Subject(s)
Patient Reported Outcome Measures , Rhinitis, Allergic , Humans , Male , Female , Prospective Studies , Adult , Rhinitis, Allergic/psychology , Rhinitis, Allergic/diagnosis , Middle Aged , Sino-Nasal Outcome Test , Mental HealthABSTRACT
OBJECTIVES: Silk-hyaluronic acid (silk-HA) is a novel vocal fold augmentation material used in humans since July 2020. We aim to describe indications, voice outcomes, and longevity data for silk-HA injectable when used for vocal fold injection (VFI) augmentation in a large cohort of patients with longer-term follow-up than preliminary clinical studies. METHODS: Retrospective chart review of Silk-HA injections for glottic insufficiency (GI) and follow-up between July 2020 and November 2023. Subject demographics, diagnoses, volume of material injected, VHI-10 data, time from injection, need for reinjection, and complications were collected. Blinded perceptual voice analysis of randomly selected pre- and post-intervention voice samples for unilateral vocal fold paralysis patients was performed by three voice-specialized speech-language pathologists, and changes in VHI-10 determined at various time intervals up to 1year and beyond. RESULTS: A total of 160 silk-HA injection procedures were performed: 59% female, with a mean age of 66± 13 (range 21-90) years. Ninety-four subjects had unilateral paralysis (58.4%); the remainder had scar, atrophy, paresis, or a combination thereof. Mean volume of silk-HA injected was 0.24± 0.14 cc. Major complications were rare, most notable for laryngoscopic evidence of hemilaryngeal edema (n = 6, 3.8%), with a readmission rate to hospital of 1.3% (n = 2). There was a statistically significant decrease in paired ΔVHI-10 and CAPE-V ratings for each of the postoperative follow-up intervals. A total of 24 (27.2%) repeat medialization procedures were recommended following silk-HA injection for unilateral paralysis. CONCLUSIONS: This study demonstrates that silk-HA is a safe product for VFI augmentation, and effective injectable for the treatment of GI due to unilateral vocal fold paralysis. Based on the current data, it is reasonable to counsel patients that they should expect benefit for several months following the injection. If patients reach 1year from their injection with a stable and satisfactory outcome, the majority experience ongoing benefit without need for additional procedures, however, the final duration of clinical effect appears to be years, but it is yet to be determined.
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OBJECTIVE: While general health may be influenced by sinonasal symptoms, their effects may be overshadowed by comorbid states which may be more serious. To assess the validity of this postulate, we measured the extent to which sinonasal symptoms and concurrent conditions influenced general health. STUDY DESIGN: Observational outcomes study. SETTING: Academic medical center, community care sites. METHODS: Adults with sinonasal symptoms completed the 22-item Sinonasal Outcome Test, along with the Patient-Reported Outcomes Measurement Information System global health short form. Comorbidities were categorized with the Deyo modification of the Charlson comorbidity index. Multivariate regression analyses were utilized to determine the relative impact of sinonasal symptoms and concurrent comorbid conditions on general health. RESULTS: Data from 219 consecutive patients demonstrated that sinonasal symptoms were associated with significantly diminished general physical (ß = -1.431, p < .001), mental (ß = -1.000, p < .001), overall (ß = -1.026, p < .001), and social health (ß = -0.872, p = .003), regardless of the presence of potentially life-threatening comorbid conditions. Comorbid conditions included cardiovascular disease, chronic obstructive pulmonary disease, connective tissue disease, peptic ulcer, diabetes mellitus, and hepatic disease. The effect of sinonasal symptoms was neither subsumed nor overshadowed by the effects of comorbid states. Nasal, ear, sleep, and psychological domain scores were also associated with general physical, mental, and global health while adjusting for the impact of comorbidities. CONCLUSION: Sinonasal symptoms have a substantial effect on general health which is not subsumed by the presence of potentially life-threatening concurrent comorbidities. These data may help support the importance of funding and resource allocation for conditions causing sinonasal symptoms.
Subject(s)
Outcome Assessment, Health Care , Quality of Life , Adult , Humans , Comorbidity , Sino-Nasal Outcome TestABSTRACT
OBJECTIVE: To determine normative values for the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) scale, a validated instrument utilized to study the impact of hearing loss and potential treatments. STUDY DESIGN: Observational outcomes study. SETTING: Academic medical center and community care sites. METHODS: We included patients who were at least 18 years of age and completed the Inner EAR scale, pure-tone audiometry, and word recognition score assessment. Based on audiometry results, patients were categorized as having: (1) normal bilateral hearing, (2) unilateral hearing loss, and (3) bilateral hearing loss. The distributions of Inner EAR scale scores were assessed within each category. Fisher's exact test was utilized to determine whether data-driven threshold values could discriminate among the 3 clinical groups. RESULTS: Two hundred and twenty-two consecutive patients with hearing-related complaints met inclusion criteria. Mean Inner EAR scores for patients with bilateral hearing loss (29.2, interquartile range [IQR] 10-41.5), unilateral hearing loss (38.9, IQR 23-49), and normal hearing (46.6, IQR 31-62) were significantly different (analysis of variance F < 0.0001). An Inner EAR score threshold of 50 supported the ability to statistically significantly discriminate between bilateral hearing loss and normal hearing (p = .003), as well as between unilateral hearing loss and normal hearing (p = .015). CONCLUSION: An Inner EAR score normative threshold value of 50 provides significant discriminatory ability between normal hearing and unilateral or bilateral hearing loss on audiometry. Normative values provide useful, frequently referenced data when assessing responses to treatment. Based on these data, this threshold may help distinguish patients with and without perceived functional impact from hearing loss.
Subject(s)
Deafness , Ear, Inner , Hearing Loss, Unilateral , Hearing Loss , Humans , Audiometry, Pure-Tone , Auditory Threshold , Hearing Loss/diagnosis , Hearing Loss, Bilateral , Hearing Loss, Unilateral/diagnosis , Adolescent , AdultABSTRACT
OBJECTIVE: Falsehood and bias can have tangible effects, whether related to the "hoax" of Corona virus disease/COVID-19 or the impact of personal protective equipment in city-wide news. The spread of false information requires the diversion of time and resources into rebolstering the truth. Our objective is thus to elucidate types of bias that may influence our daily work, along with ways to mitigate them. DATA SOURCES: Publications are included which delineate specific aspects of bias or address how to preempt, mitigate, or correct bias, whether conscious or unconscious. REVIEW METHODS: We discuss: (1) the background and rationale for proactively considering potential sources of bias, (2) relevant definitions and concepts, (3) potential means to limit effects of inaccurate data sources, and (4) evolving frontiers in the management of bias. In doing so, we review epidemiological concepts and susceptibility to bias within study designs, including database studies, observational studies, randomized controlled trials (RCTs), systematic reviews, and meta-analyses. We additionally discuss concepts such as the difference between disinformation and misinformation, differential or nondifferential misclassification, bias toward a null result, and unconscious bias, among others. CONCLUSION: We have the means to mitigate sources of potential bias in database studies, observational studies, RCTs, and systematic reviews, beginning with education and awareness. IMPLICATIONS FOR PRACTICE: False information may spread faster than true information, so it is beneficial to understand potential sources of falsehood we face, in order to safeguard our daily impressions and decisions. Awareness of potential sources of falsehood and bias forms the foundation for accuracy in our everyday work.
Subject(s)
COVID-19 , Humans , Bias , Evidence-Based MedicineABSTRACT
Qualitative methods have been increasingly applied in our literature, providing richness to data and incorporating the nuances of patient and family perspectives. These qualitative research techniques provide breadth and depth beyond what can be gleaned through quantitative methods alone. When both quantitative and qualitative approaches are coupled, their findings provide complementary information which can further substantiate study conclusions. We thus aim to provide insight into qualitative and quantitative methods in comparison and contrast to each other, as well as guidance on when each approach is most apt. In relation, we also describe mixed methods and the theory supporting their framework. In doing so, we provide the foundation for an ensuing, more detailed exposition of qualitative methods.
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OBJECTIVES: To assess: (1) the Eating Assessment Tool (EAT-10) with item response theory (IRT) to determine which individual items provide the most information, (2) the extent to which dysphagia is measured with subsets of items while maintaining precise score estimates, and (3) if 5-item scales have the differing discriminatory ability, as compared to the parent 10-item instrument. METHODS: Prospectively collected data from 2,339 patients who completed the EAT-10 questionnaire during evaluation at a tertiary care otolaryngology clinic were utilized. IRT analyses provided discrimination and location parameters associated with individual questions. Residual item correlations were also assessed for redundant information. Based on these results, three 5-item subsets were further evaluated using item information function curves. Areas under receiver-operator characteristic curves (ROC-AUC) were also calculated to evaluate the discriminatory ability for dysphagia-related clinical diagnoses. RESULTS: Item discrimination parameter estimates ranged from 1.71 to 5.46, with higher values indicating more information. Residual item correlations were determined within item pairs, and location parameters were calculated. Based on these data, in combination with clinical utility, three 5-item subsets were proposed and assessed. ROC-AUC analyses demonstrated no significant difference between the EAT-5-Alpha subset and the original 10-item instrument for discriminating dysphagia as a primary diagnosis (0.88, 0.88). The EAT-5-Clinical subset outperformed the original 10 instruments in ROC-AUC for aspiration. The EAT-5-Range subset was significantly associated with problems with thin liquids. CONCLUSIONS: IRT analyses distinguished three proposed 5-item subsets of the EAT-10 instrument, supporting shorter survey options, while still reflecting the impact of dysphagia without significant loss of discrimination. LEVEL OF EVIDENCE: 3 (Diagnostic testing with consistently applied reference standards, partial blinding). Laryngoscope, 133:3327-3333, 2023.
Subject(s)
Deglutition Disorders , Humans , Deglutition Disorders/diagnosis , ROC Curve , Surveys and Questionnaires , Reproducibility of ResultsABSTRACT
OBJECTIVE: To offer pragmatic, evidence-informed guidance on the use of systemic corticosteroids (SCS) for common otolaryngologic disorders. DATA SOURCES: PubMed, Cochrane Library, and American Academy of Otolaryngology-Head and Neck Surgery Foundation clinical practice guidelines. REVIEW METHODS: A comprehensive search of published literature through November 2021 was conducted on the efficacy of SCS, alone or in combination with other treatments, for managing disorders in otolaryngology and the subdisciplines. Clinical practice guidelines, systematic reviews, and randomized controlled trials, when available, were preferentially retrieved. Interventions and outcomes of SCS use were compiled to generate summary tables and narrative synthesis of findings. CONCLUSIONS: Evidence on the effectiveness of SCS varies widely across otolaryngology disorders. High-level evidence supports SCS use for Bell's palsy, sinonasal polyposis, and lower airway disease. Conversely, evidence is weak or absent for upper respiratory tract infection, eustachian tube dysfunction, benign paroxysmal positional vertigo, adenotonsillar hypertrophy, or nonallergic rhinitis. Evidence is indeterminate for acute laryngitis, acute pharyngitis, acute sinusitis, angioedema, chronic rhinosinusitis without polyps, Ménière's disease, postviral olfactory loss, postoperative nerve paresis/paralysis, facial pain, and sudden sensorineural hearing loss. IMPLICATIONS FOR PRACTICE: Clinicians should bring an evidence-informed lens to SCS prescribing to best counsel patients regarding the risks, anticipated benefits, and limited data on long-term effects. Alternate routes of corticosteroid administration-such as sprays, drops, inhalers, and intralesional injections-may be preferable for many disorders, particularly those that are self-limited or require a prolonged duration of therapy. Prudent use of SCS reduces the risk of medication-related adverse effects. Clinicians who are conversant with high-level evidence can achieve optimal outcomes and stewardship when prescribing SCS.
Subject(s)
Bell Palsy , Otolaryngology , Otorhinolaryngologic Diseases , Sinusitis , Humans , Steroids , Adrenal Cortex Hormones/therapeutic use , Otorhinolaryngologic Diseases/drug therapy , Otorhinolaryngologic Diseases/surgery , Bell Palsy/drug therapy , Sinusitis/drug therapy , Sinusitis/surgeryABSTRACT
Importance: Identification and preservation of parathyroid glands (PGs) remain challenging despite advances in surgical techniques. Considerable morbidity and even mortality result from hypoparathyroidism caused by devascularization or inadvertent removal of PGs. Emerging imaging technologies hold promise to improve identification and preservation of PGs during thyroid surgery. Observation: This narrative review (1) comprehensively reviews PG identification and vascular assessment using near-infrared autofluorescence (NIRAF)-both label free and in combination with indocyanine green-based on a comprehensive literature review and (2) offers a manual for possible implementation these emerging technologies in thyroid surgery. Conclusions and Relevance: Emerging technologies hold promise to improve PG identification and preservation during thyroidectomy. Future research should address variables affecting the degree of fluorescence in NIRAF, standardization of signal quantification, definitions and standardization of parameters of indocyanine green injection that correlate with postoperative PG function, the financial effect of these emerging technologies on near-term and longer-term costs, the adoption learning curve and effect on surgical training, and long-term outcomes of key quality metrics in adequately powered randomized clinical trials evaluating PG preservation.
Subject(s)
Hypoparathyroidism , Parathyroid Glands , Humans , Parathyroid Glands/diagnostic imaging , Parathyroid Glands/surgery , Thyroid Gland/diagnostic imaging , Thyroid Gland/surgery , Indocyanine Green , Optical Imaging/adverse effects , Optical Imaging/methods , Thyroidectomy/methods , Hypoparathyroidism/etiologyABSTRACT
The coronavirus 2019 pandemic has increased the use of powered air-purifying respirator (PAPR) devices, which produce appreciable noise levels during filtration. Our objective was to determine if active PAPR usage significantly impairs auditory communication in health care providers. We additionally sought to assess what volume of speech presentation was required for adequate communication with providers wearing a PAPR. In subjects with normal hearing at baseline, audiometric data demonstrated a 93% (95% CI, 86%-99%) decrease in word recognition scores during active PAPR usage. Presentation at 85 to 90 dB was needed to obtain word recognition scores similar to baseline in subjects with normal hearing without a PAPR. Pure tone averages also significantly decreased with PAPR usage, by 54 dB (95% CI, 46-62). Active PAPR usage has a substantial impact on auditory perception when utilized by health care providers. The potential longer-term effect of these devices on providers with regular active usage is of interest for future study.
Subject(s)
Coronavirus Infections , Respiratory Protective Devices , Health Personnel , Humans , PandemicsABSTRACT
Background: The noninvasive subtype of encapsulated follicular variant of papillary thyroid carcinoma (eFVPTC) has been reclassified as noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) in 2016 to reflect the indolent behavior and favorable prognosis of this type of tumor. This terminology change has also de-escalated its management approach from cancer treatment to a more conservative treatment strategy befitting a benign thyroid neoplasm. Objective: To characterize the reduced health care costs and improved quality of life (QOL) from management of NIFTP as a nonmalignant tumor compared with the previous management as eFVPTC. Methods: A cost-effectiveness analysis was performed by creating Markov models to simulate two management strategies for NIFTP: (i) de-escalated management of the tumor as NIFTP involving lobectomy with reduced follow-up, (ii) management of the tumor as eFVPTC involving completion thyroidectomy/radioactive iodine ablation for some patients, and follow-up recommended for carcinoma. The model was simulated for 5 and 20 years following diagnosis of NIFTP. Aggregate costs and quality-life years were measured. One-way sensitivity analysis was performed for all variables. Results: Over a five-year simulation period, de-escalated management of NIFTP had a total cost of $12,380.99 per patient while the more aggressive management of the tumor as eFVPTC had a total cost of $16,264.03 per patient (saving $3883.05 over five years). Management of NIFTP provided 5.00 quality-adjusted life years, whereas management as eFVPTC provided 4.97 quality-adjusted life years. Sensitivity analyses showed that management of NIFTP always resulted in lower costs and greater quality-adjusted life years (QALYs) over the sensitivity ranges for individual variables. De-escalated management for NIFTP is expected to produce â¼$6-42 million in cost savings over a five-year period for these patients, and incremental 54-370 QALYs of increased utility in the United States. Conclusion: The degree of cost savings and improved patient utility of de-escalated NIFTP management compared with traditional management was estimated to be $3883.05 and 0.03 QALYs per patient. We demonstrate that these findings persisted in sensitivity analysis to account for variability in recurrence rate, surveillance approaches, and other model inputs. These findings allow for greater understanding of the economic and QOL impact of the NIFTP reclassification.
Subject(s)
Adenocarcinoma, Follicular , Thyroid Neoplasms , Adenocarcinoma, Follicular/surgery , Cost-Benefit Analysis , Humans , Iodine Radioisotopes , Quality of Life , Retrospective Studies , Thyroid Cancer, Papillary/pathology , Thyroid Neoplasms/diagnosis , Thyroid Neoplasms/surgeryABSTRACT
Importance: Prior publications have reported the sporadic development of sensorineural hearing loss (SNHL) after intravenous or high-dose macrolide therapy for adults with comorbid conditions, but investigations of the auditory effect of oral outpatient dosing for children, adolescents, and young adults have been limited. Objective: To determine whether broad-based outpatient use of oral macrolide therapy is associated with increased risk of pediatric SNHL through nationally representative analyses. Design, Setting, and Participants: A retrospective case-control study of 875 matched pairs of children, adolescents, and young adults was performed, matching on age, sex, and the time elapsed since prescription date. All eligible pediatric patients were included, with matched control participants from the TRICARE US military health insurance system who were evaluated between October 1, 2009, and September 30, 2014. Exposures: Oral outpatient macrolide treatment compared with penicillin use among pediatric patients. Main Outcomes and Measures: The clinical outcome of interest was SNHL in children, adolescents, and young adults. Multivariable conditional logistic regression was used to compare the risk of prior macrolide exposure with penicillin exposure, adjusted for other risk factors and potential confounders. Four time frames between exposure and diagnosis were additionally assessed. Results: There were 875 eligible matched pairs of children, adolescents, and young adults included. The mean (SD) age of the participants was 5.7 (4.9) years; 1082 participants were male (62%), 58 were Asian (3%), 254 were Black (15%), 1152 were White (66%), and 286 were of Native American and other (no further breakdown was available in the TRICARE database) race and ethnicity (16%). In multivariable analysis, participants who had SNHL had increased odds of having received a macrolide prescription compared with a penicillin prescription when all time frames from exposure were included (adjusted odds ratio, 1.31; 95% CI, 1.05-1.64). There were significantly higher odds of macrolide exposure than penicillin exposure when diagnosis and testing occurred more than 180 days after antibiotic exposure (adjusted odds ratio, 1.79; 95% CI, 1.23-2.60). Conclusions and Relevance: In this case-control study of a nationally representative patient population, findings suggest that children, adolescents, and young adults with SNHL had increased odds of outpatient oral macrolide use compared with penicillin use, particularly when having received a diagnosis more than 180 days after exposure. Further study of the association of macrolides with SNHL in children, adolescents, and young adults is warranted.
Subject(s)
Hearing Loss, Sensorineural , Macrolides , Adolescent , Anti-Bacterial Agents/adverse effects , Case-Control Studies , Child , Child, Preschool , Female , Hearing Loss, Sensorineural/epidemiology , Humans , Macrolides/adverse effects , Male , Outpatients , Penicillins , Retrospective Studies , Young AdultABSTRACT
HYPOTHESIS: Computed tomography (CT) density measurement can be used to objectively distinguish otosclerosis from normal bone and to determine histologic grades of otosclerosis. BACKGROUND: Otosclerosis can be seen on CT as subtle radiolucent areas. An objective radiologic measurement that corresponds to known otosclerosis pathology may improve diagnostic accuracy, and could be used as a radiologic biomarker for otosclerosis grade. METHODS: A blinded, randomized evaluation of both histologic grade on histopathology slides and CT density measurement was performed on 78 human temporal bone specimens (31 with otosclerosis and 47 controls) that had undergone high-resolution multi-detector CT before histologic processing. Assessments were performed at 11 regions of interest (ROIs) in the otic capsule for each specimen. RESULTS: The CT density measurement mean (Hounsfield Units) ± standard deviation for all ROIs (Nos. 1-9) was 2245 ± 854 for grade 0 (no otosclerosis, n = 711), 1896 ± 317 for grade 1 (inactive otosclerosis, n = 109), and 1632 ± 255 for grades 2 and 3 combined (mixed/active otosclerosis, n 35). There was a strong inverse correlation of CT density to histologic grade at ROIs Nos. 1-5 (ANOVA, p < 0.0001). The inter-rater reliability for CT density was very good (correlation coefficient 0.87, p < 0.05). ROC curves suggested a cut-off of 2,150HU to distinguish otosclerosis from normal bone, and 1,811HU to distinguish low grade from mixed/high grade otosclerosis. CONCLUSIONS: In human temporal bone specimens, CT density may be used to distinguish normal bone from bone involved by otosclerosis. A higher histologic grade (i.e., indicating a more active otosclerotic focus) correlated with lower density.
Subject(s)
Otosclerosis , Biomarkers , Humans , Otosclerosis/pathology , Reproducibility of Results , Temporal Bone/diagnostic imaging , Temporal Bone/pathology , Tomography, X-Ray Computed/methodsABSTRACT
OBJECTIVE: To offer pragmatic, evidence-informed advice on administering corticosteroids in otolaryngology during the coronavirus disease 2019 (COVID-19) pandemic, considering therapeutic efficacy, potential adverse effects, susceptibility to COVID-19, and potential effects on efficacy of vaccination against SARS-CoV-2, which causes COVID-19. DATA SOURCES: PubMed, Cochrane Library, EMBASE, CINAHL, and guideline databases. REVIEW METHODS: Guideline search strategies, supplemented by database searches on sudden sensorineural hearing loss (SSNHL), idiopathic facial nerve paralysis (Bell's palsy), sinonasal polyposis, laryngotracheal disorders, head and neck oncology, and pediatric otolaryngology, prioritizing systematic reviews, randomized controlled trials, and COVID-19-specific findings. CONCLUSIONS: Systemic corticosteroids (SCSs) reduce long-term morbidity in individuals with SSNHL and Bell's palsy, reduce acute laryngotracheal edema, and have benefit in perioperative management for some procedures. Topical or locally injected corticosteroids are preferable for most other otolaryngologic indications. SCSs have not shown long-term benefit for sinonasal disorders. SCSs are not a contraindication to vaccination with COVID-19 vaccines approved by the US Food and Drug Administration. The Centers for Disease Control and Prevention noted that these vaccines are safe for immunocompromised patients. IMPLICATIONS FOR PRACTICE: SCS use for SSNHL, Bell's palsy, laryngotracheal edema, and perioperative care should follow prepandemic standards. Local or topical corticosteroids are preferable for most other otolaryngologic indications. Whether SCSs attenuate response to vaccination against COVID-19 or increase susceptibility to SARS-CoV-2 infection is unknown. Immunosuppression may lower vaccine efficacy, so immunocompromised patients should adhere to recommended infection control practices. COVID-19 vaccination with Pfizer-BioNTech, Moderna, or Johnson & Johnson vaccines is safe for immunocompromised patients.
Subject(s)
Bell Palsy , COVID-19 , Facial Paralysis , Otolaryngology , Child , Humans , Bell Palsy/drug therapy , COVID-19 Vaccines , SARS-CoV-2 , Otolaryngology/methodsABSTRACT
Children are more likely to experience recurrent laryngeal nerve (RLN) injury during thyroid surgery. Intraoperative nerve monitoring (IONM) may assist in nerve identification and surgical decision making. A literature review of pediatric IONM was performed and used to inform a monitoring technique guide and expert opinion statements. Pediatric IONM is achieved using a variety of methods. When age-appropriate endotracheal tubes with integrated surface electrodes are not available, an alternative method should be used. Patient age and surgeon experience with laryngoscopy influence technique selection; four techniques are described in detail. Surgeons must be familiar with the nuances of monitoring technique and interpretation; opinion statements address optimizing this technology in children. Adult IONM guidelines may offer strategies for surgical decision making in children. In some cases, delay of second-sided surgery may reduce bilateral RLN injury risk.