Higher SARS-CoV-2 detection of oropharyngeal compared with nasopharyngeal or saliva specimen for molecular testing: a multicentre randomised comparative accuracy study.

BACKGROUND: Testing is critical for detecting SARS-CoV-2 infection, but the best sampling method remains unclear. OBJECTIVES: To determine whether nasopharyngeal swab (NPS), oropharyngeal swab (OPS) or saliva specimen collection has the highest detection rate for SARS-CoV-2 molecular testing. METHODS: We conducted a randomised clinical trial at two COVID-19 outpatient test centres where NPS, OPS and saliva specimens were collected by healthcare workers in different orders for reverse transcriptase PCR testing. The SARS-CoV-2 detection rate was calculated as the number positive by a specific sampling method divided by the number in which any of the three sampling methods was positive. As secondary outcomes, test-related discomfort was measured with an 11-point numeric scale and cost-effectiveness was calculated. RESULTS: Among 23 102 adults completing the trial, 381 (1.65%) were SARS-CoV-2 positive. The SARS-CoV-2 detection rate was higher for OPSs, 78.7% (95% CI 74.3 to 82.7), compared with NPSs, 72.7% (95% CI 67.9 to 77.1) (p=0.049) and compared with saliva sampling, 61.9% (95% CI 56.9 to 66.8) (p<0.001). The discomfort score was highest for NPSs, at 5.76 (SD, 2.52), followed by OPSs, at 3.16 (SD 3.16) and saliva samples, at 1.03 (SD 18.8), p<0.001 between all measurements. Saliva specimens were associated with the lowest cost, and the incremental costs per detected SARS-CoV-2 infection for NPSs and OPSs were US$3258 and US$1832, respectively. CONCLUSIONS: OPSs were associated with higher SARS-CoV-2 detection and lower test-related discomfort than NPSs for SARS-CoV-2 testing. Saliva sampling had the lowest SARS-CoV-2 detection but was the least costly strategy for mass testing. TRIAL REGISTRATION NUMBER: NCT04715607.

Using Virtual Reality Head-Mounted Displays to Assess Skills in Emergency Medicine: Validity Study.

BACKGROUND: Many junior doctors must prepare to manage acutely ill patients in the emergency department. The setting is often stressful, and urgent treatment decisions are needed. Overlooking symptoms and making wrong choices may lead to substantial patient morbidity or death, and it is essential to ensure that junior doctors are competent. Virtual reality (VR) software can provide standardized and unbiased assessment, but solid validity evidence is necessary before implementation. OBJECTIVE: This study aimed to gather validity evidence for using 360-degree VR videos with integrated multiple-choice questions (MCQs) to assess emergency medicine skills. METHODS: Five full-scale emergency medicine scenarios were recorded with a 360-degree video camera, and MCQs were integrated into the scenarios to be played in a head-mounted display. We invited 3 groups of medical students with different experience levels to participate: first- to third-year medical students (novice group), last-year medical students without emergency medicine training (intermediate group), and last-year medical students with completed emergency medicine training (experienced group). Each participant's total test score was calculated based on the number of correct MCQ answers (maximum score of 28), and the groups' mean scores were compared. The participants rated their experienced presence in emergency scenarios using the Igroup Presence Questionnaire (IPQ) and their cognitive workload with the National Aeronautics and Space Administration Task Load Index (NASA-TLX). RESULTS: We included 61 medical students from December 2020 to December 2021. The experienced group had significantly higher mean scores than the intermediate group (23 vs 20; P=.04), and the intermediate group had significantly higher scores than the novice group (20 vs 14; P<.001). The contrasting groups' standard-setting method established a pass-or-fail score of 19 points (68% of the maximum possible score of 28). Interscenario reliability was high, with a Cronbach α of 0.82. The participants experienced the VR scenarios with a high degree of presence with an IPQ score of 5.83 (on a scale from 1-7), and the task was shown to be mentally demanding with a NASA-TLX score of 13.30 (on a scale from 1-21). CONCLUSIONS: This study provides validity evidence to support using 360-degree VR scenarios to assess emergency medicine skills. The students evaluated the VR experience as mentally demanding with a high degree of presence, suggesting that VR is a promising new technology for emergency medicine skills assessment.

Effectiveness of Adding a Mask Recommendation to Other Public Health Measures to Prevent SARS-CoV-2 Infection in Danish Mask Wearers : A Randomized Controlled Trial.

BACKGROUND: Observational evidence suggests that mask wearing mitigates transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is uncertain if this observed association arises through protection of uninfected wearers (protective effect), via reduced transmission from infected mask wearers (source control), or both. OBJECTIVE: To assess whether recommending surgical mask use outside the home reduces wearers' risk for SARS-CoV-2 infection in a setting where masks were uncommon and not among recommended public health measures. DESIGN: Randomized controlled trial (DANMASK-19 [Danish Study to Assess Face Masks for the Protection Against COVID-19 Infection]). (ClinicalTrials.gov: NCT04337541). SETTING: Denmark, April and May 2020. PARTICIPANTS: Adults spending more than 3 hours per day outside the home without occupational mask use. INTERVENTION: Encouragement to follow social distancing measures for coronavirus disease 2019, plus either no mask recommendation or a recommendation to wear a mask when outside the home among other persons together with a supply of 50 surgical masks and instructions for proper use. MEASUREMENTS: The primary outcome was SARS-CoV-2 infection in the mask wearer at 1 month by antibody testing, polymerase chain reaction (PCR), or hospital diagnosis. The secondary outcome was PCR positivity for other respiratory viruses. RESULTS: A total of 3030 participants were randomly assigned to the recommendation to wear masks, and 2994 were assigned to control; 4862 completed the study. Infection with SARS-CoV-2 occurred in 42 participants recommended masks (1.8%) and 53 control participants (2.1%). The between-group difference was -0.3 percentage point (95% CI, -1.2 to 0.4 percentage point; P = 0.38) (odds ratio, 0.82 [CI, 0.54 to 1.23]; P = 0.33). Multiple imputation accounting for loss to follow-up yielded similar results. Although the difference observed was not statistically significant, the 95% CIs are compatible with a 46% reduction to a 23% increase in infection. LIMITATION: Inconclusive results, missing data, variable adherence, patient-reported findings on home tests, no blinding, and no assessment of whether masks could decrease disease transmission from mask wearers to others. CONCLUSION: The recommendation to wear surgical masks to supplement other public health measures did not reduce the SARS-CoV-2 infection rate among wearers by more than 50% in a community with modest infection rates, some degree of social distancing, and uncommon general mask use. The data were compatible with lesser degrees of self-protection. PRIMARY FUNDING SOURCE: The Salling Foundations.

Point-of-care ultrasound for general practitioners: a systematic needs assessment.

Objective: The aim of the study was to achieve consensus among a group of ultrasound proficient general practitioners (GPs) from Denmark, Norway, Sweden and Finland on which ultrasound scanning modalities and ultrasound-guided procedures are essential to GPs in their daily work for the purpose of including them in a basic ultrasound curriculum.Design: The Delphi methodology was used to obtain consensus.Subjects: Sixty Scandinavian GPs with more than two years of point-of-care ultrasound (POCUS) experience were invited to join the Delphi expert panel.Main outcome measures: In the first Delphi round each member of the panel was asked to produce a list of scanning modalities and procedures which they found relevant to include in a basic ultrasound curriculum. In Delphi round two, these suggestions were presented to the entire panel who assessed whether they found them essential in their daily work. Items not reaching consensus in round two, were presented to the panel in a third and final round. Items reaching more than 67% agreement were included.Results: Forty-five GPs were included in the study and 41 GPs completed all rounds. Agreement was obtained on 30 scanning modalities and procedures primarily within the musculoskeletal (8), abdominal (5), obstetric (5) and soft tissue (3) diagnostic areas. Four ultrasound-guided procedures were also agreed upon.Conclusion: A prioritized list of 30 scanning modalities and procedures was agreed upon by a group of ultrasound proficient GPs. This list could serve as a guideline when planning future POCUS educational activities for GPs.Key pointsPoint-of-care ultrasound (POCUS) is increasingly being used by general practitioners (GPs), but little is known about which ultrasound applications are most used.We performed a systematic needs assessment among a group of ultrasound proficient GPs using the Delphi methodology for the purpose of establishing a basic POCUS curriculum.The process resulted in a prioritized list of 30 scanning modalities and ultrasound guided procedures.Our study provides the basis for an evidence-based basic POCUS curriculum for GPs.

Cost-Effectiveness of Mobile App-Guided Training in Extended Focused Assessment with Sonography for Trauma (eFAST): A Randomized Trial.

PURPOSE: Ultrasound training is associated with a long learning curve and use of substantial faculty resources. Self-directed ultrasound training may decrease the need for faculty-led teaching. Mobile apps seem promising for use in self-directed ultrasound training, but no studies have examined the cost-effectiveness of mobile app-guided training versus traditional formats such as textbook-guided training. This study evaluated the cost-effectiveness of mobile app-guided versus textbook-guided ultrasound training. MATERIAL AND METHODS: First-year residents (n = 38) with no previous ultrasound experience were randomized into mobile app-guided versus textbook-guided self-directed ultrasound training groups. Participants completed a transfer test involving four patient cases and a theoretical test on diagnostic accuracy. Two ultrasound experts assessed the residents' performance using the Objective Structured Assessment of Ultrasound Skills (OSAUS) scale. The costs of developing mobile app and textbook material were calculated and used for the analysis of cost-effectiveness. RESULTS: 34 participants completed the transfer test. There was no statistically significant difference in test performance or diagnostic accuracy between the mobile app-guided (mean-OSAUS 42.3 % [95 %CI38.5 - 46.0 %]) and textbook-guided groups (mean-OSAUS 45.3 % [95 %CI39.3 - 51.3 %]) (d.f. [1.33] = 0.45, p = 0.41). However, development costs differed greatly for each instructional format. Textbook-guided training was significantly more cost-effective than mobile app-guided training (Incremental Cost Effectiveness Ratio -861 967 [95 %CI-1071.7 to-3.2] USD/pct. point change in OSAUS score). CONCLUSION: Mobile app-guided ultrasound training is less cost-effective than textbook-guided self-directed training. This study underlines the need for careful evaluation of cost-effectiveness when introducing technological innovations for clinical skills training.

Self-directed simulation-based training of emergency cricothyroidotomy: a route to lifesaving skills.

The emergency cricothyroidotomy (EC) is a critical procedure. The high cost of failures increases the demand for evidence-based training methods. The aim of this study was to present and evaluate self-directed video-guided simulation training. Novice doctors were given an individual 1-h simulation training session. One month later, an EC on a cadaver was performed. All EC's were video recorded. An assessment tool was used to rate performance. Performance was compared with a pass/fail level for the EC. We found a high reliability, based on Pearson's r (0.88), and a significant progression of skill during training (p < 0.001). Eleven out of 14 succeeded in creating an airway on the cadaver in 64 s (median, range 39-86 s), but only four achieved a passing score. Our 1-h training protocol successfully raised the competence level of novice doctors; however, the training did not ensure that all participants attained proficiency.

Reliable and valid assessment of point-of-care ultrasonography.

OBJECTIVE: To explore the reliability and validity of the Objective Structured Assessment of Ultrasound Skills (OSAUS) scale for point-of-care ultrasonography (POC US) performance. BACKGROUND: POC US is increasingly used by clinicians and is an essential part of the management of acute surgical conditions. However, the quality of performance is highly operator-dependent. Therefore, reliable and valid assessment of trainees' ultrasonography competence is needed to ensure patient safety. METHODS: Twenty-four physicians, representing novices, intermediates, and experts in POC US, scanned 4 different surgical patient cases in a controlled set-up. All ultrasound examinations were video-recorded and assessed by 2 blinded radiologists using OSAUS. Reliability was examined using generalizability theory. Construct validity was examined by comparing performance scores between the groups and by correlating physicians' OSAUS scores with diagnostic accuracy. RESULTS: The generalizability coefficient was high (0.81) and a D-study demonstrated that 1 assessor and 5 cases would result in similar reliability. The construct validity of the OSAUS scale was supported by a significant difference in the mean scores between the novice group (17.0; SD 8.4) and the intermediate group (30.0; SD 10.1), P = 0.007, as well as between the intermediate group and the expert group (72.9; SD 4.4), P = 0.04, and by a high correlation between OSAUS scores and diagnostic accuracy (Spearman ρ correlation coefficient = 0.76; P < 0.001). CONCLUSIONS: This study demonstrates high reliability as well as evidence of construct validity of the OSAUS scale for assessment of POC US competence. Hence, the OSAUS scale may be suitable for both in-training as well as end-of-training assessment.

Head and neck ultrasound training improves the diagnostic performance of otolaryngology residents.

Objective: Surgeon-performed head and neck ultrasound (US) is increasingly used among otolaryngologists in office-based and surgical settings. However, it is unknown how formal US training affects otolaryngology residents' diagnostic workup of patients with cervical pathology. This study examined how a formal US course for residents affected their outpatient clinic US performance and diagnostic accuracy. Methods: We conducted a randomized cross-over trial, where 13 otolaryngology residents participated in a 6-h formal US course. Participants were randomized to perform head and neck US on four patient cases before and after completing the course. Eight patients with and without neck pathology were invited to participate as test cases. The ultrasound examinations were video recorded and anonymized before two consultants rated the US performance using the Objective Structured Assessment of Ultrasound Skills (OSAUS) scale. Otolaryngology residents wrote an ultrasound report with a diagnosis based on their US examination, which was used to calculate the specificity and sensitivity. Results: We found a statistically significant difference in the OSAUS score before compared to after the hands-on training (p = .035). The diagnostic accuracy also increased from 62% before the course to 75% after the course (p = .02). Specificity increased from 54% prior to the course to 62% following the course, and sensitivity increased from 64% prior to the course to 79% following the course. The intraclass correlation coefficient with "absolute agreement" was 0.63. Conclusion: This study demonstrates that short, formal ultrasound training can improve otolaryngology residents' ultrasound skills and diagnostic accuracy in an outpatient clinic setting. Lay summary: This study looks at the change of otolaryngology residents' diagnostic workup of patients after they take a formal ultrasound course and shows that they get better at using ultrasound and make more accurate diagnoses if they take a formal course. Level of Evidence: Level 2.

Intraoral Ultrasound versus MRI for Depth of Invasion Measurement in Oral Tongue Squamous Cell Carcinoma: A Prospective Diagnostic Accuracy Study.

Oral squamous cell carcinoma (OSCC) of the tongue is the most common type of oral cavity cancer, and tumor depth of invasion (DOI) is an important prognostic factor. In this study, we investigated the accuracy of intraoral ultrasound and magnetic resonance imaging (MRI) for assessing DOI in patients with OSCC. Histopathological measurement of DOI was used as a reference standard. We conducted a prospective study including patients planned for surgical treatment of OSCC in the tongue. The DOI was measured in an outpatient setting by intraoral ultrasound and MRI, and was compared to the histopathological DOI measurements. Bland-Altman analysis compared the mean difference and 95% limits of agreement (LOA) for ultrasound and MRI, and the Wilcoxon signed-rank test was used to test for significance. The correlation was evaluated using Pearson's correlation coefficient. We included 30 patients: 26 with T1 or T2 tumors, and 4 with T3 tumors. The mean difference from histopathology DOI was significantly lower for ultrasound compared to MRI (0.95 mm [95% LOA -4.15 mm to 6.06 mm] vs. 1.90 mm [95% LOA -9.02 mm and 12.81 mm], p = 0.023). Ultrasound also led to significantly more correct T-stage classifications in 86.7% (26) of patients compared to 56.7% (17) for MRI, p = 0.015. The Pearson correlation between MRI and histopathology was 0.57 (p < 0.001) and the correlation between ultrasound and histopathology was 0.86 (p < 0.001). This prospective study found that intraoral ultrasound is more accurate than MRI in assessing DOI and for the T-staging of oral tongue cancers. Clinical practice and guidelines should implement intraoral ultrasound accordingly.

Molecular Detection of SARS-CoV-2 From Throat Swabs Performed With or Without Specimen Collection From the Tonsils: Protocol for a Multicenter Randomized Controlled Trial.

BACKGROUND: Testing for SARS-CoV-2 is essential to provide early COVID-19 treatment for people at high risk of severe illness and to limit the spread of infection in society. Proper upper respiratory specimen collection is the most critical step in the diagnosis of the SARS-CoV-2 virus in public settings, and throat swabs were the preferred specimens used for mass testing in many countries during the COVID-19 pandemic. However, there is still a discussion about whether throat swabs have a high enough sensitivity for SARS-CoV-2 diagnostic testing, as previous studies have reported a large variability in the sensitivity from 52% to 100%. Many previous studies exploring the diagnostic accuracy of throat swabs lack a detailed description of the sampling technique, which makes it difficult to compare the different diagnostic accuracy results. Some studies perform a throat swab by only collecting specimens from the posterior oropharyngeal wall, while others also include a swab of the palatine tonsils for SARS-CoV-2 testing. However, studies suggest that the palatine tonsils could have a tissue tropism for SARS-CoV-2 that may improve the SARS-CoV-2 detection during sampling. This may explain the variation of sensitivity reported, but no clinical studies have yet explored the differences in sensitivity and patient discomfort whether the palatine tonsils are included during the throat swab or not. OBJECTIVE: The objective of this study is to examine the sensitivity and patient discomfort of a throat swab including the palatine tonsils compared to only swabbing the posterior oropharyngeal wall in molecular testing for SARS-CoV-2. METHODS: We will conduct a randomized controlled study to compare the molecular detection rate of SARS-CoV-2 by a throat swab performed from the posterior oropharyngeal wall and the palatine tonsils (intervention group) or the posterior oropharyngeal wall only (control group). Participants will be randomized in a 1:1 ratio. All participants fill out a baseline questionnaire upon enrollment in the trial, examining their reason for being tested, symptoms, and previous tonsillectomy. A follow-up questionnaire will be sent to participants to explore the development of symptoms after testing. RESULTS: A total of 2315 participants were enrolled in this study between November 10, 2022, and December 22, 2022. The results from the follow-up questionnaire are expected to be completed at the beginning of 2024. CONCLUSIONS: This randomized clinical trial will provide us with information about whether throat swabs including specimens from the palatine tonsils will improve the diagnostic sensitivity for SARS-CoV-2 molecular detection. These results can, therefore, be used to improve future testing recommendations and provide additional information about tissue tropism for SARS-CoV-2. TRIAL REGISTRATION: ClinicalTrials.gov NCT05611203; https://clinicaltrials.gov/study/NCT05611203. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47446.

Mesenchymal Stem/Stromal Cell Therapy for Radiation-Induced Xerostomia in Previous Head and Neck Cancer Patients: A Phase II Randomized, Placebo-Controlled Trial.

PURPOSE: No effective treatment exists for radiation-induced xerostomia. The objective of this study was to compare the effect of adipose-derived mesenchymal stem/stromal cell (ASC) injection, relative to placebo, on salivary gland function in patients with radiation-induced xerostomia. PATIENT AND METHODS: In this single-centre, double-blind, placebo-controlled trial, patients with hyposalivation were randomised to receive ultrasound-guided injections of allogeneic ASCs or placebo into the submandibular glands. Patients were followed for 4 months. We evaluated unstimulated whole salivary flow rate (UWS), stimulated salivary flow rate, and patient-reported outcomes. Adverse events were recorded and immune response determined in blood samples. RESULTS: We enrolled 120 patients. ASC treatment resulted in a statistically significant UWS increase of 0.04 [95% confidence interval (CI), 0.02-0.06] mL/min (38%) compared with pretreatment baseline whereas placebo treatment did not cause a significant increase [0.01 (95% CI, -0.01 to 0.04) mL/min (21%)]. Both the ASC and placebo treatment yielded notable symptom reductions, with dry mouth decreasing by 13.6 and 7.7 units, sticky saliva decreased by 14.8 and 9.3 units, swallowing difficulties decreased by 7.9 and 8.0 units, and the summary score of the Xerostomia Questionnaire decreased 5.9 and 5.1 units for the ASC and placebo arms, respectively. We found no statistically significant group difference between the ASC and placebo arms for any of the outcomes. CONCLUSIONS: We could not confirm superiority of the ASC relative to placebo. ASC therapy significantly improved UWS in previous patients with head and neck cancer, whereas placebo resulted in an insignificant increase.

Comparison of Transoral and Transcervical Ultrasonography with MRI for the Diagnostic Work-Up of Oropharynx Tumors: A Protocol for a Multicenter Clinical Trial (SPOTUS).

This study protocol for a prospective, multicenter, diagnostic, clinical trial describes the integration of transoral and transcervical ultrasonography (US) in the initial clinical work-up of patients referred to tertiary head and neck cancer centers with suspected oropharyngeal cancer. The study evaluates the blinded detection rate of oropharyngeal tumors and their US-estimated size and T-stage before histopathology and cross-sectional imaging are available. Magnetic resonance imaging (MRI) scans will be prospectively rated while blinded to T-site histopathology and US. The primary outcome measures of diagnostic accuracy, including sensitivity, specificity, positive and negative predictive values, and overall accuracy, will be reported for both US and MRI. A sub-analysis of prospectively rated 18F-Fluorodeoxyglucose (FDG) positron emission tomography/computerized tomography (PET/CT) scans in patients with clinically suspected unknown primary tumors will also be compared to US and MRI. Secondary outcome measures, including a comparison of tumor size estimation between US, MRI, and CT, will also be reported. This prospective multicenter study will provide clinically impactful information regarding the use of transoral and transcervical US for the diagnostic work-up of oropharyngeal cancer.

Short- and long-term transfer of urethral catheterization skills from simulation training to performance on patients.

BACKGROUND: Inexperienced interns are responsible for most iatrogenic complications after urethral catheterization (UC). Although training on simulators is common, little is known about the transfer of learned skills to real clinical practice. This study aimed to evaluate the short- and long-term effects of UC simulated skills training on performance on real patients and to examine whether watching a video of the procedure immediately before assessment enhanced clinical performance. METHODS: This was an experimental study of the effect of a UC simulation-based skills course on medical students' short-term (after one week) and long-term (after six weeks) performance. The additional effect of video instruction before performance testing on real patients was studied in a randomized trial. Sixty-four students participated in the study, which was preceded by a pilot study investigating the validity aspects of a UC assessment form. RESULTS: The pilot study demonstrated sufficient inter-rater reliability, intra-class correlation coefficient 0.86, and a significant ability to discriminate between trainee performances when using the assessment form, p= 0.001. In the main study, more than 90% of students demonstrated an acceptable performance or better when tested on real patients. There was no significant difference in the total score between the one-week and the six-week groups when tested on real patients and no significant difference between the video and the control groups. CONCLUSIONS: Medical students demonstrated good transfer of UC skills learned in the skills lab to real clinical situations up to six weeks after training. Simulated UC training should be the standard for all medical school curricula to reduce avoidable complications. However, this study did not demonstrate that an instructional video, as a supplement to simulated skills training, improved clinical UC performance. TRIAL REGISTRATION: Current Controlled Trials ISRCTN:ISRCTN90745002.

Diagnostics and treatment of cysts of the neck.

Different congenital and acquired lesions can present as a cystic mass of the neck. The diagnostics and treatment of these is described in this review. Ultrasound and fine-needle aspiration biopsy are essential in the diagnostic workup of neck cysts, and especially cysts located laterally in the neck in adults over 40 years of age require further examination, due to the risk of malignancy. Treatment of the cysts depends on the type and location and can consist of aspiration, surgery, and sclerotherapy. Especially cystic thyroid nodules and macrocystic lymphatic malformations may be treated with schlerotherapy.

Transoral Ultrasound in the Outpatient Clinic for the Diagnostic Work-Up of Oropharyngeal Cancer: A Feasibility Study.

Magnetic resonance imaging (MRI) is the preferred imaging modality for oropharyngeal cancers (OPCs), but it has difficulties distinguishing between small OPCs and unilateral tonsil hypertrophy. We hypothesized that surgeon-performed transoral ultrasound (US) could be used to accurately detect T-stage OPCs. We performed a single-center prospective diagnostic accuracy study including patients with suspected or biopsy-verified OPCs during outpatient appointments. All patients were offered transoral US and MRI. If transoral US could not be tolerated by the patient, transcervical US was performed. The primary outcome was the diagnostic accuracy of detecting OPCs with US compared to MRI, using histopathology as the reference standard. The secondary outcome was comparing the primary tumor diameters between US and MRI blinded to each other. Out of the 26 patients included in the study, 21 (81%) had OPCs. Transoral US could be performed in 21/21 and 1/5 patients with suspected palatine and lingual tonsil OPCs, respectively. Overall, US diagnostic accuracy was 92%, compared to 81% with MRI (p = 0.37). US and MRI had a high correlation between tumor diameters in the anteroposterior diameter (R = 0.80, p < 0.001), corresponding to the depth axis on US. In conclusion, this small study showed the promise and feasibility of transoral US to improve the initial clinical evaluations of patients with suspected OPCs.

Head-to-Head Comparison of Nasopharyngeal, Oropharyngeal and Nasal Swabs for SARS-CoV-2 Molecular Testing.

Nasopharyngeal swabs (NPS) are considered the gold standard for SARS-CoV-2 testing but are technically challenging to perform and associated with discomfort. Alternative specimens for viral testing, such as oropharyngeal swabs (OPS) and nasal swabs, may be preferable, but strong evidence regarding their diagnostic sensitivity for SARS-CoV-2 testing is still missing. We conducted a head-to-head prospective study to compare the sensitivity of NPS, OPS and nasal swabs specimens for SARS-CoV-2 molecular testing. Adults with an initial positive SARS-CoV-2 test were invited to participate. All participants had OPS, NPS and nasal swab performed by an otorhinolaryngologist. We included 51 confirmed SARS-CoV-2-positive participants in the study. The sensitivity was highest for OPS at 94.1% (95% CI, 87 to 100%) compared to NPS at 92.5% (95% CI, 85 to 99%) (p = 1.00) and lowest for nasal swabs at 82.4% (95% CI, 72 to 93%) (p = 0.07). Combined OPS/NPS was detected in 100% of cases, while the combined OPS/nasal swab increased the sensitivity significantly to 96.1% (95% CI, 90 to 100%) compared to that of the nasal swab alone (p = 0.03). The mean Ct value for NPS was 24.98 compared to 26.63 for OPS (p = 0.084) and 30.60 for nasal swab (p = 0.002). OPS achieved a sensitivity comparable to NPS and should be considered an equivalent alternative for SARS-CoV-2 testing.

3D Ultrasound and MRI in Assessing Resection Margins during Tongue Cancer Surgery: A Research Protocol for a Clinical Diagnostic Accuracy Study.

Surgery is the primary treatment for tongue cancer. The goal is a complete resection of the tumor with an adequate margin of healthy tissue around the tumor.Inadequate margins lead to a high risk of local cancer recurrence and the need for adjuvant therapies. Ex vivo imaging of the resected surgical specimen has been suggested for margin assessment and improved surgical results. Therefore, we have developed a novel three-dimensional (3D) ultrasound imaging technique to improve the assessment of resection margins during surgery. In this research protocol, we describe a study comparing the accuracy of 3D ultrasound, magnetic resonance imaging (MRI), and clinical examination of the surgical specimen to assess the resection margins during cancer surgery. Tumor segmentation and margin measurement will be performed using 3D ultrasound and MRI of the ex vivo specimen. We will determine the accuracy of each method by comparing the margin measurements and the proportion of correctly classified margins (positive, close, and free) obtained by each technique with respect to the gold standard histopathology.

COVID-19 Rapid Antigen Tests With Self-Collected vs Health Care Worker-Collected Nasal and Throat Swab Specimens: A Randomized Clinical Trial.

Importance: Self- or health care worker (HCW)-collected nasal swab specimens are the preferred sampling method to perform rapid antigen testing for COVID-19, but it is debated whether throat specimens can improve test sensitivity. Objective: To compare the diagnostic accuracy of self- and HCW-collected nasal vs throat swab specimens for COVID-19 rapid antigen testing. Design, Setting, and Participants: This per-protocol multicenter randomized clinical trial was conducted from February 15 through March 25, 2022. The participants, individuals aged 16 years or older requesting a COVID-19 test for diagnostic or screening purposes, had 4 specimens collected for individual testing at 1 of 2 urban COVID-19 outpatient test centers in Copenhagen, Denmark. Interventions: Participants were randomized 1:1 to self-collected or HCW-collected nasal and throat swab specimens for rapid antigen testing. Additional HCW-collected nasal and throat swab specimens for reverse transcriptase-polymerase chain reaction (RT-PCR) were used as the reference standard. Main Outcomes and Measures: The primary outcome was sensitivity to diagnose COVID-19 of a self- vs HCW-collected nasal and throat specimen for rapid antigen testing compared with RT-PCR. Results: Of 2941 participants enrolled, 2674 (90.9%) had complete test results and were included in the final analysis (1535 [57.4%] women; median age, 40 years [IQR, 28-55 years]); 1074 (40.2%) had COVID-19 symptoms, and 827 (30.9%) were positive for SARS-CoV-2 by RT-PCR. Health care worker-collected throat specimens had higher mean sensitivity than HCW-collected nasal specimens for rapid antigen testing (69.4% [95% CI, 65.1%-73.6%] vs 60.0% [95% CI, 55.4%-64.5%]). However, a subgroup analysis of symptomatic participants found that self-collected nasal specimens were more sensitive than self-collected throat specimens for rapid antigen testing (mean sensitivity, 71.5% [95% CI, 65.3%-77.6%] vs 58.0% [95% CI, 51.2%-64.7%]; P < .001). Combining nasal and throat specimens increased sensitivity for HCW- and self-collected specimens by 21.4 and 15.5 percentage points, respectively, compared with a single nasal specimen (both P < .001). Conclusions and Relevance: This randomized clinical trial found that a single HCW-collected throat specimen had higher sensitivity for rapid antigen testing for SARS-CoV-2 than a nasal specimen. In contrast, the self-collected nasal specimens had higher sensitivity than throat specimens for symptomatic participants. Adding a throat specimen to the standard practice of collecting a single nasal specimen could improve sensitivity for rapid antigen testing in health care and home-based settings. Trial Registration: ClinicalTrials.gov Identifier: NCT05209178.