Defining Food Safety Inspection.

 Food safety inspections are a key health protection measure applied by governments to prevent foodborne illness, yet they remain the subject of sustained criticism. These criticisms include inconsistency and inadequacy of methods applied to inspection, and ineffectiveness in preventing foodborne illness. Investigating the validity of these criticisms represent important areas for further research. However, a defined construct around the meanings society attributes to food safety inspection must first be established. Through critical examination of available literature, this review identified meanings attributed to food safety inspection and explicates some of the key elements that compose food safety inspection as a social construct. A total of 18 meanings were found to be attributed to food safety inspection. Variation in meanings were found between consumers, food business associates and food safety inspectors. For some, inspection meant a source of assurance, for others a threat to fairness, while most view inspection as a product of resources and inspector training. The meanings were then examined in light of common criticisms directed at food safety inspection, to expound their influence in how food safety inspection is realized, shaped, and rationalized. This review highlights the influence of sociological factors in defining food safety inspection. .

COVID-19 Incidence and Death Rates Among Unvaccinated and Fully Vaccinated Adults with and Without Booster Doses During Periods of Delta and Omicron Variant Emergence - 25 U.S. Jurisdictions, April 4-December 25, 2021.

Previous reports of COVID-19 case, hospitalization, and death rates by vaccination status† indicate that vaccine protection against infection, as well as serious COVID-19 illness for some groups, declined with the emergence of the B.1.617.2 (Delta) variant of SARS-CoV-2, the virus that causes COVID-19, and waning of vaccine-induced immunity (1-4). During August-November 2021, CDC recommended§ additional primary COVID-19 vaccine doses among immunocompromised persons and booster doses among persons aged ≥18 years (5). The SARS-CoV-2 B.1.1.529 (Omicron) variant emerged in the United States during December 2021 (6) and by December 25 accounted for 72% of sequenced lineages (7). To assess the impact of full vaccination with additional and booster doses (booster doses),¶ case and death rates and incidence rate ratios (IRRs) were estimated among unvaccinated and fully vaccinated adults by receipt of booster doses during pre-Delta (April-May 2021), Delta emergence (June 2021), Delta predominance (July-November 2021), and Omicron emergence (December 2021) periods in the United States. During 2021, averaged weekly, age-standardized case IRRs among unvaccinated persons compared with fully vaccinated persons decreased from 13.9 pre-Delta to 8.7 as Delta emerged, and to 5.1 during the period of Delta predominance. During October-November, unvaccinated persons had 13.9 and 53.2 times the risks for infection and COVID-19-associated death, respectively, compared with fully vaccinated persons who received booster doses, and 4.0 and 12.7 times the risks compared with fully vaccinated persons without booster doses. When the Omicron variant emerged during December 2021, case IRRs decreased to 4.9 for fully vaccinated persons with booster doses and 2.8 for those without booster doses, relative to October-November 2021. The highest impact of booster doses against infection and death compared with full vaccination without booster doses was recorded among persons aged 50-64 and ≥65 years. Eligible persons should stay up to date with COVID-19 vaccinations.

Degree of preoperative hearing loss predicts time to early mobilization following vestibular schwannoma microsurgery.

OBJECTIVE: To test the hypothesis that severe to profound preoperative hearing loss predicts less acute postoperative vestibulopathy following microsurgical removal of vestibular schwannoma (VS) allowing for earlier postoperative mobilization and hospital discharge. METHODS: Patients with VS who underwent microsurgery and were found to have preoperative severe to profound hearing loss (pure tone average [PTA] > 70 dB HL) were matched 1:1 by age and tumor size to a group of randomly selected controls with preoperative serviceable hearing. RESULTS: A total of 57 patients met inclusion criteria and were matched to controls. Median age at the time of microsurgery was 56 years. The median PTA and WRS for cases were 91 dB HL (interquartile range [IQR] 78-120) and 0% (IQR 0-0), respectively. Median tumor size was 14.2 mm (IQR 10.9-20.9). A total of 35 (61%) patients exhibited nystagmus after surgery associated with acute vestibular deafferentation. Median time to ambulation in the hallway was 2 days. Controls exhibited similar tumor size (12.7 mm, p = 0.11) and age (57 years, p = 0.52). Preoperative hearing loss did not predict severity or duration of postoperative nystagmus or days to discharge; however, those with Class D hearing exhibited a shorter time to ambulation (p = 0.04). CONCLUSION: Following microsurgical removal of VS, preoperative profound hearing loss was associated with a shorter time to postoperative mobilization; however, there were no observed associations with duration or severity of nystagmus and time to hospital discharge. Although not a predictor of nystagmus, preoperative profound hearing loss may portend quicker recovery from clinically significant postoperative vestibulopathy.

Subcutaneous Air Around Receiver-Stimulator Causing Open-Circuit Failures: An Uncommon But Readily Treatable Condition Related to CPAP Use After Cochlear Implant Surgery.

OBJECTIVE: To raise awareness of a unique complication associated with continuous positive airway pressure (CPAP) use after cochlear implantation to improve early detection, prevent unnecessary testing, and facilitate treatment. STUDY DESIGN: Case series. SETTING: Tertiary referral center. SUBJECTS: Patients who developed subcutaneous air around the receiver-stimulator device and the associated ground electrode in the setting of CPAP usage, which resulted in open-circuit electrode failures. MAIN OUTCOME MEASURES: Clinical course and intervention. RESULTS: Two patients were identified that fit this criterion. Both patients were noted to have poor implant performance secondary to high or open impedances and concomitant emphysema surrounding the cochlear implant receiver-stimulator. Manual massage offered transient improvement, but programming changes ultimately led to improved sound quality and resolution of impedance anomalies in both cases. CONCLUSIONS: Subcutaneous air collection surrounding the cochlear implant receiver-stimulator in the setting of CPAP use is an uncommon but clinically relevant complication that can be recognized by characteristic physical examination findings and impedance changes. Early and accurate recognition of this event can prevent unnecessary testing and facilitate early effective treatment.

Impact of Treatment on Vestibular Schwannoma-Associated Symptoms: A Prospective Study Comparing Treatment Modalities.

OBJECTIVE: The degree to which various treatment modalities modify vestibular schwannoma (VS)-associated symptoms has received limited attention. The purpose of this study was to determine how different treatment modalities affect subjective symptoms in those presenting with VS. STUDY DESIGN: Prospective survey. SETTING: Tertiary neurotology referral center. METHODS: Patients with sporadic VS who received treatment at our institution were prospectively surveyed with a VS symptom questionnaire. Those who completed a baseline survey prior to treatment and at least 1 posttreatment survey were included. The prospective survey evaluated the severity of self-reported symptoms (Likert scale, 1-10), including tinnitus, dizziness or imbalance, headaches, and hearing loss. RESULTS: A total of 244 patients were included (mean age, 57 years). The mean duration of follow-up was 2.1 years, and the median number of surveys completed was 2 (interquartile range, 1-3). Seventy-eight (32%) cases were managed with observation, 118 (48%) with microsurgery, and 48 (20%) with radiosurgery. Multivariable analyses revealed no statistically significant difference in the change in tinnitus (P = .15), dizziness or imbalance (P = 0.66), or headaches (P = .24) among treatment groups. Evaluation of clinically important differences demonstrated that microsurgery leads to significant bidirectional changes in headaches. CONCLUSIONS: Limited prospective data exist regarding the progression or resolution of subjective symptoms in those presenting with VS. This study suggests that tinnitus, dizziness or imbalance, and headaches are unlikely to be significantly modified by treatment modality and generally should not be used to direct treatment choice.

Elevated Urine Leukotriene E4 Is Associated With Worse Objective Markers in Nasal Polyposis Patients.

OBJECTIVES: Urine leukotriene E4 (uLTE4) is a biomarker of leukotriene synthesis and is elevated in patients with aspirin-exacerbated respiratory disease (AERD). It can also be useful to help delineate aspirin-tolerant chronic rhinosinusitis with nasal polyposis (CRSwNP) patients from AERD patients. The purpose of this study is to determine if uLTE4 biomarker levels are associated with objective and subjective markers of disease severity in patients with CRSwNP. METHODS: A retrospective analysis of CRSwNP patients who underwent uLTE4 testing was completed to determine the association of uLTE4 levels to markers of disease severity. uLTE4 levels, as well as presenting subjective (Sinonasal Outcome Test 22 [SNOT22] scores, asthma control test [ACT] scores) and objective data (Lund-Mackay CT score, spirometry and lab values) were collected. RESULTS: Among the 157 CRSwNP patients who met inclusion criteria, uLTE4 levels were associated with history of asthma (P < .001), aspirin sensitivity (P < .001), worse Lund-Mackay CT scores (P = .002) and other objective markers of disease severity including serum IgE (P = .05), presenting blood eosinophil level (P < .001), and the highest recorded eosinophil level (P < .001). In subgroup analysis, associations of uLTE4 to disease markers had stronger correlations in the aspirin sensitive CRSwNP group (R range 0.31-0.52) than the aspirin tolerant CRSwNP group (R range -0.30-0.24). uLTE4 levels were not associated with subjective symptom scores (SNOT22 and ACT scores). CONCLUSION: Elevated uLTE4 biomarker levels are associated with worsened objective markers of disease severity in CRSwNP patients but not patient-reported symptom measures. LEVEL OF EVIDENCE: 3 Laryngoscope, 131:961-966, 2021.

Clinical Utility of Intraoperative Electrocochleography (ECochG) During Cochlear Implantation: A Systematic Review and Quantitative Analysis.

OBJECTIVE: To evaluate the utility of intraoperative electrocochleography (ECochG) as a predictive tool for preservation of residual acoustic hearing after cochlear implantation. DATA SOURCES: A systematic review employing a multi-database search strategy (Ovid MEDLINE, Embase, EBM Cochrane, and Scopus) was conducted from inception to August 1, 2019. English language studies in humans were included. STUDY SELECTION: All articles were independently reviewed by two authors according to Preferred Reporting Items of Systematic Reviews and Meta-analysis (PRISMA) guidelines. Studies without intraoperative ECochG obtained during cochlear implantation were excluded. DATA EXTRACTION: Extracted variables included number of patients, ECochG recording technique, success rate of obtaining ECochG potentials, intraoperative changes in ECochG signal, and postoperative hearing preservation outcomes. DATA SYNTHESIS: Among 537 eligible articles, 22 met inclusion criteria encompassing 498 unique patients. Ten studies featured extracochlear measurements, eight featured intracochlear measurements, and four featured both. Extracochlear ECochG had an average (SD) recording success rate of 94.9% (12.7%) while intracochlear ECochG had an average (SD) recording success rate of 91.8% (9.8%). One hundred forty five unique patients from six studies had complete intraoperative ECochG data with postoperative behavioral audiometry. After accounting for study-specific definitions of ECochG signal disturbance, worsening changes in intraoperative ECochG signal predicted postoperative hearing loss with limited sensitivity and specificity and notable heterogeneity across studies. CONCLUSIONS: Intraoperative ECochG recordings can be obtained in over 90% of patients, but accuracy in predicting postoperative hearing loss remains limited. Standardization of intraoperative ECochG monitoring technique and data interpretation are necessary to more robustly investigate outcomes and refine technique.

Audiometric Profile of Cochlear Implant Recipients Demonstrates Need for Revising Insurance Coverage.

OBJECTIVES/HYPOTHESIS: To describe the pre-implant audiometric profile of adult cochlear implant (CI) recipients to investigate whether current binaural candidacy requirements prevent access to patients who could benefit from CI. STUDY DESIGN: Retrospective case series. METHODS: Retrospective review from 2016 to 2018 evaluating preoperative pure-tone thresholds and speech perception scores in the ipsilateral and contralateral ear. RESULTS: A total of 252 adult CI recipients undergoing 270 implants were identified. Median age at time of implantation was 70.5 years (IQR 61.3-78.3) for those undergoing unilateral implantation and 59.0 (IQR 48.0-72.3) for those undergoing bilateral implantation (P < .01). For unilateral implantation, median pre-implantation speech perception performance in the ear to be implanted was 8.0% (IQR 0%-26.0%) for CNC word scores, and 9.0% (IQR 0%-34.0%) for AzBio sentence scores in quiet. Median speech perception performance in the contralateral ear was 36.0% (IQR 14.0%-60.0%) on CNC word scores, and 48.5% (IQR 17.5%-76.0%) on AzBio sentence tests. Speech perception scores were significantly different between ears for word and sentence tests (P < .01). Patients older than age 65 were significantly less likely to undergo bilateral implantation (P = .03). CONCLUSIONS: Adult CI recipients exhibit substantially poorer pre-implant speech perception scores than the commonly utilized ipsilateral qualifying threshold of 50% on sentence testing. Yet, existing insurance paradigms limit patients by excessively stringent binaural best-aided requirements. This limitation likely leads to worse device performance as patients often wait years for their binaural hearing to qualify while their ear to be implanted potentially experiences an unnecessarily extended duration of deafness. Older patients also experience a unique delay in referral for cochlear implantation. LEVEL OF EVIDENCE: 3- Retrospective review Laryngoscope, 131:E2007-E2012, 2021.

Prospective Study of Disease-Specific Quality-of-Life in Sporadic Vestibular Schwannoma Comparing Observation, Radiosurgery, and Microsurgery.

BACKGROUND: Previous cross-sectional studies analyzing quality of life (QOL) outcomes in patients with sporadic vestibular schwannoma (VS) have shown surprisingly little difference among treatment modalities. To date, there is limited prospective QOL outcome data available comparing baseline to posttreatment scores. STUDY DESIGN: Prospective longitudinal study using the disease-specific Penn Acoustic Neuroma Quality of Life (PANQOL) scale. SETTING: Large academic skull base center. PATIENTS: Patients diagnosed with unilateral VS who completed a baseline survey before treatment and at least one posttreatment survey. MAIN OUTCOME MEASURES: Change in PANQOL scores from baseline to most recent survey. RESULTS: A total of 244 patients were studied, including 78 (32%) who elected observation, 118 (48%) microsurgery, and 48 (20%) stereotactic radiosurgery. Patients who underwent microsurgery were younger (p < 0.001) and had larger tumors (p < 0.001) than those who underwent observation or radiosurgery; there was no significant difference in duration of follow-up among management groups (mean 2.1 yrs; p = 0.28). When comparing the total PANQOL score at baseline to the most recent survey, the net change was only -1.1, -0.1, and 0.3 points on a 100-point scale for observation, microsurgery, and radiosurgery, respectively (p = 0.89). After multivariable adjustment for baseline features, there were no statistically significant changes when comparing baseline to most recent scores within each management group for facial function, general health, balance, hearing loss, energy, and pain domains or total score. However, the microsurgical group experienced a 10.8-point improvement (p = 0.002) in anxiety following treatment, compared with 1.5 (p = 0.73) and 5.3 (p = 0.31) for observation and radiosurgery, respectively. CONCLUSIONS: In this prospective longitudinal study investigating differences in QOL outcomes among VS treatment groups using the disease-specific PANQOL instrument, treatment did not modify QOL in most domains. Microsurgery may confer an advantage with regard to patient anxiety, presumably relating to the psychological benefit of "cure" from having the tumor removed.

Cardiothoracic Patients with Unilateral Vocal Fold Paralysis: Pneumonia Rates Following Injection Laryngoplasty.

OBJECTIVE: Recurrent laryngeal nerve injury is a potential complication of cardiothoracic surgery and cause of unilateral vocal fold paralysis (UVFP). Injection laryngoplasty (IL) is an intervention offered to patients with UVFP to alleviate symptoms including dysphagia, dysphonia and weak cough. There is no definitive evidence that IL prevents pneumonia. In this study, we compare rates of pneumonia in patients with UVFP secondary to cardiothoracic surgery who did or did not undergo IL. METHODS: A retrospective chart review identified patients diagnosed with UVFP by an otolaryngologist using flexible laryngoscopy following cardiothoracic surgery from January 1, 2008 to December 31, 2017. Each subject was grouped by IL status and assessed for subsequent pneumonia within 6 months of their diagnosis of UVFP. The association of IL with pneumonia was evaluated using Cox proportional hazards regression. RESULTS: Of 92 patients who met inclusion criteria, 35 (38%) underwent IL and 57 (62%) did not. Twenty patients developed pneumonia, four who had undergone IL and 16 who had not; 12 patients developed aspiration pneumonia including two having undergone IL and 10 who had not. Those who had IL were less likely to develop total pneumonia compared to those who had not (HR = 0.33, P = .045). The protective effect of IL was not as clearly sustained when measuring for aspiration pneumonia, specifically (HR = 0.34; P = .10). DISCUSSION: Injection laryngoplasty may reduce the risk of pneumonia in patients with UVFP secondary to cardiothoracic surgery; however, further research is needed to quantify the potential protective nature of IL in this patient population. LEVEL OF EVIDENCE: 3 (A retrospective cohort study).

Creation of a New Educational Podcast: "Headmirror's ENT in a Nutshell".

Podcasts are online digital audio programs that are disseminated via online subscription that are easily accessible through computers or smartphones. Increasingly, residents and medical students are prioritizing podcasts for asynchronous medical education due to ease of use, convenience (eg, use while exercising or commuting), and repeatability. Some trainees have found podcasts more useful than traditional didactic lectures. Given the increasing requirements of social distancing and the need for distance medical education platforms, podcast production can serve as a useful tool to complement resident and medical student education and is a resource that will remain accessible in perpetuity. An otolaryngology specialty podcast, "Headmirror's ENT in a Nutshell," was created to augment asynchronous learning and address the acute need for distance learning opportunities. Over the first 7 weeks of production, 50 episodes were created. Episodes were posted on www.headmirror.com, with subscription services available through Apple Podcast, Spotify, and other platforms.

Protein Stability in Titan's Subsurface Water Ocean.

Models of Titan predict that there is a subsurface ocean of water and ammonia under a layer of ice. Such an ocean would be important in the search for extraterrestrial life since it provides a potentially habitable environment. To evaluate how Earth-based proteins would behave in Titan's subsurface ocean environment, we used molecular dynamics simulations to calculate the properties of proteins with the most common secondary structure types (alpha helix and beta sheet) in both Earth and Titan-like conditions. The Titan environment was simulated by using a temperature of 300 K, a pressure of 1000 bar, and a eutectic mixture of water and ammonia. We analyzed protein compactness, flexibility, and backbone dihedral distributions to identify differences between the two environments. Secondary structures in the Titan environment were found to be less long-lasting, less flexible, and had small differences in backbone dihedral preferences (e.g., in one instance a pi helix formed). These environment-driven differences could lead to changes in how these proteins interact with other biomolecules and therefore changes in how evolution would potentially shape proteins to function in subsurface ocean environments.

Obliquity Evolution of the Potentially Habitable Exoplanet Kepler-62f.

Variations in the axial tilt, or obliquity, of terrestrial planets can affect their climates and therefore their habitability. Kepler-62f is a 1.4 R⊕ planet orbiting within the habitable zone of its K2 dwarf host star. We perform N-body simulations that monitor the evolution of obliquity of Kepler-62f for 10-million-year timescales to explore the effects on model assumptions, such as the masses of the Kepler-62 planets and the possibility of outer bodies. Significant obliquity variation occurs when the rotational precession frequency overlaps with one or more of the secular orbital frequencies, but most variations are limited to ≲10°. Moderate variations (∼10-20°) can occur over a broader range of initial obliquities when the relative nodal longitude (ΔΩ) overlaps with the frequency and phase of a given secular mode. However, we find that adding outer gas giants on long-period orbits (∼1000 days) can produce large (∼60°) variations in obliquity if Kepler-62f has a very rapid (4 h) rotation period. The possibility of giant planets on long-period orbits impacts the climate and habitability of Kepler-62f through variations in the latitudinal surface flux, where large variations can occur on million year timescales.

Temporary bronchial stenting for airway compression in the interstage palliation of functional single ventricle.

The Norwood procedure is the first of three palliative surgical procedures offered for hypoplastic left heart syndrome (HLHS). Due to the small size of the thorax and proximity of airway and vascular structures, compression of the airway is possible following the Norwood procedure. We describe the management of an infant with HLHS following Stage I surgical palliation who developed refractory respiratory failure secondary to severe left bronchial compression.

Strategies for Detecting Biological Molecules on Titan.

Saturn's moon Titan has all the ingredients needed to produce "life as we know it." When exposed to liquid water, organic molecules analogous to those found on Titan produce a range of biomolecules such as amino acids. Titan thus provides a natural laboratory for studying the products of prebiotic chemistry. In this work, we examine the ideal locales to search for evidence of, or progression toward, life on Titan. We determine that the best sites to identify biological molecules are deposits of impact melt on the floors of large, fresh impact craters, specifically Sinlap, Selk, and Menrva craters. We find that it is not possible to identify biomolecules on Titan through remote sensing, but rather through in situ measurements capable of identifying a wide range of biological molecules. Given the nonuniformity of impact melt exposures on the floor of a weathered impact crater, the ideal lander would be capable of precision targeting. This would allow it to identify the locations of fresh impact melt deposits, and/or sites where the melt deposits have been exposed through erosion or mass wasting. Determining the extent of prebiotic chemistry within these melt deposits would help us to understand how life could originate on a world very different from Earth. Key Words: Titan-Prebiotic chemistry-Solar system exploration-Impact processes-Volcanism. Astrobiology 18, 571-585.

A novel method to measure the external auditory canal: Normative data and practical implications.

PURPOSE: To accurately measure external auditory canal (EAC) dimensions by high resolution computed tomography (CT), and compare results with a traditional method of EAC measurement. METHODS: Using an advanced multidimensional open source digital imaging and communications in medicine (DICOM) analysis program (OsiriX, Pixmeo, Geneva, Switzerland) 91 adult EACs were analyzed on a previously obtained temporal bone CT scan. Tympanometric data were also recorded for each ear. The methods were compared using a linear mixed effect model. RESULTS: EAC volume was compared between tympanometrically calculated volumes and CT measured volumes. It was found that CT measured volumes are, on average, smaller (1.12cm3, SE=0.04) than tympanometry volumes (1.27cm3, SE=0.04cm3). There was a significant difference in CT measured volume between genders (p=0.0125), with males having larger measured volumes (1.23cm3, SD=0.28cm3) than females (1.06cm3, SD=0.20cm3). There was a significant difference in average circumference between ear laterality (p=0.0071), with the right ear having a slightly larger average circumference (2.49cm, SD=0.23cm) than the left ear (2.44cm, SD=0.50cm).There was also a significant difference in minimum circumference between age groups (p=0.0448), with patients younger than 60years having larger minimum circumferences (1.89cm, SD=0.21cm) than older patients (1.78cm, SD=0.25cm). CONCLUSIONS: This study demonstrates that CT analysis can provide more information about EAC dimensions than traditional techniques. Moreover, slight but statistically significant differences are associated with age, gender and laterality. Accurate estimation of EAC dimensions is important for the development of hearing aids and personal protective equipment and can also be helpful for surgical planning, specifically otoendoscopy. Future research will focus on simplifying computation, developing cross-cultural cohort comparisons, and application to otoendoscopic procedures.