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.

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.

Effectiveness and safety of mesenchymal stem/stromal cell for radiation-induced hyposalivation and xerostomia in previous head and neck cancer patients (MESRIX-III): a study protocol for a single-centre, double-blinded, randomised, placebo-controlled, phase II study.

BACKGROUND: A predominant side effect of radiotherapy for head and neck cancer is salivary gland hypofunction and xerostomia leading to debilitating oral disorders and impaired quality of life (QoL). Intraglandular mesenchymal stem cell therapy has shown promising results as a treatment for xerostomia. METHODS: This is a randomised, double-blinded, placebo-controlled, parallel-group, prospective, single-centre trial investigating the safety, tolerability, and effectiveness of allogeneic stem cells as a treatment for radiation-induced hyposalivation and xerostomia for previous head and neck cancer patients. We will include a total of 120 patients who previously have been treated with radiotherapy for a head and neck cancer in Denmark. Participants will be randomly assigned using block randomisation to one of two parallel groups in a 1:1 ratio to receive ultrasound-guided injection of allogeneic adipose-derived mesenchymal stem cell (ASC) (n = 60) or placebo (n = 60) into the submandibular glands. Placebo will consist of CryoStor10 (BiolifeSolutions), the freeze media for ASCs containing 10% dimethyl sulfoxide (DMSO). The primary endpoint is change in unstimulated whole saliva flow rate. The secondary endpoints are change in stimulated whole saliva flow rate, QoL, and composition of saliva. Further secondary endpoints are safety and immune response (human leukocyte antigen (HLA) response) to the stem cells will be assessed. Patients are evaluated at baseline (before treatment), after 4 months, and after 12 months. All study personnel, except study personnel thawing and preparing the treatment for injection, and participants will be blinded to group assignment. Unblinded study personnel will not participate in the outcome assessment. DISCUSSION: The trials will investigate the efficacy and safety of ASC injection to the submandibular gland as a potential new treatment for post-radiation xerostomia. We hope the results will pave the way for a clinically relevant treatment to ameliorate patients with xerostomia, a severely hampering condition. TRIAL REGISTRATION: The study is approved by the Danish Data Protection Agency (protocol number P-2020-1164), the National Ethics Committee protocol number: (Protocol number: 1802872), and the Danish Medical Agency (2018-000348-24). The protocol was registered at the ClinicalTrials.gov database (NCT04776538).

Intraglandular mesenchymal stem cell treatment induces changes in the salivary proteome of irradiated patients.

BACKGROUND: Hyposalivation and xerostomia (dry mouth), are the leading site-effects to treatment of head and neck cancer. Currently, there are no effective therapies to alleviate radiation-induced hyposalivation. Adipose tissue-derived mesenchymal stem/stromal cells (AT-MSCs) have shown potential for restoring salivary gland function. However, the mode of action is unknown. The purpose of the present study was therefore to characterize the effect of AT-MSC therapy on the salivary proteome in previously irradiated head and neck cancer patients. METHODS: Whole saliva was collected from patients with radiation-induced salivary gland hypofunction (n = 8) at baseline, and 120 days after AT-MSC treatment, and from healthy controls (n = 10). The salivary proteome was characterized with mass spectrometry based proteomics, and data was compared within the AT-MSC group (baseline versus day 120) and between AT-MSC group and healthy controls. Significance levels between groups were determined by using double-sided t-test, and visualized by means of principal component analysis, volcano plots and cluster analysis. RESULTS: Here we show that 140 human proteins are significantly differentially expressed in saliva from patients with radiation-induced hypofunction versus healthy controls. AT-MSC treatment induce a significant impact on the salivary proteome, as 99 proteins are differentially expressed at baseline vs. 120 days after treatment. However, AT-MSC treatment does not restore healthy conditions, as 212 proteins are significantly differentially expressed in saliva 120 days after AT-MSCs treatment, as compared to healthy controls. CONCLUSION: The results indicate an increase in proteins related to tissue regeneration in AT-MSCs treated patients. Our study demonstrates the impact of AT-MSCs on the salivary proteome, thereby providing insight into the potential mode of action of this novel treatment approach.

Currently, there are no effective treatments to ease dry mouth, which is a leading long-term side effect of radiation treatment for head and neck cancer. However, treatment with stem cells has shown potential for restoring function of the salivary glands, which are damaged due to radiation. We compared proteins in saliva of previously radiation-treated patients with healthy non-irradiated persons and found differences in the levels of 140 proteins. After stem cell treatment of irradiated patients, we found changes in the salivary content of proteins related to tissue regeneration. Our study demonstrates the impact of stem cell treatment on proteins in saliva, thereby providing insight into the potential mode of action of this treatment approach for patients with radiation-induced dry mouth. Consequently, this could potentially help to improve treatment of dry mouth in the future.

Intraglandular Off-the-Shelf Allogeneic Mesenchymal Stem Cell Treatment in Patients with Radiation-Induced Xerostomia: A Safety Study (MESRIX-II).

No effective therapy exists for the most common long-term side effect of radiation therapy for head and neck cancer (HNC)-xerostomia. The objective was to evaluate safety and provide proof of concept for efficacy of allogeneic adipose tissue-derived mesenchymal stem/stromal cells (AT-MSCs) injected into the major salivary glands of irradiated patients. This open-label, first-in-human, phase 1b, and single-center trial was conducted with repeated measurements days 0, 1, 5, and 30 and 4 months. Eligible patients with objective and subjective signs of radiation-induced salivary gland damage after treatment of oropharyngeal squamous cell carcinoma stages I-II (UICC 8) were enrolled. Twenty-five million cryopreserved AT-MSCs were injected into each submandibular and 50 million AT-MSCs into each parotid gland. Data were collected on adverse events, unstimulated and stimulated whole saliva (UWS and SWS) flow rates and saliva composition, patient-reported outcomes (EORTC QLQ-H&N35 and Xerostomia Questionnaire [XQ]), blood samples and salivary gland scintigraphy. Data were analyzed using repeated measures linear mixed models. Ten patients (7 men, 3 women, 59.5 years [range: 45-70]) were treated in 4 glands. No treatment-related serious adverse events occurred. During 4 months, UWS flow rate increased from 0.13 mL/minute at baseline to 0.18 mL/minute with a change of 0.06 (P = .0009) mL/minute. SWS flow rate increased from 0.66 mL/minute at baseline to 0.75 mL/minute with a change of 0.09 (P = .017) mL/minute. XQ summary score decreased by 22.6 units (P = .0004), EORTC QLQ-H&N35 dry mouth domains decreased by 26.7 (P = .0013), sticky saliva 23.3 (P = .0015), and swallowing 10.0 (P = .0016). Our trial suggests treatment of the major salivary glands with allogenic AT-MSCs is safe, warranting confirmation in larger trials.

Valid and Reliable Assessment of Upper Respiratory Tract Specimen Collection Skills during the COVID-19 Pandemic.

Proper specimen collection is the most important step to ensure accurate testing for the coronavirus disease 2019 (COVID-19) and other infectious diseases. Assessment of healthcare workers' upper respiratory tract specimen collection skills is needed to ensure samples of high-quality clinical specimens for COVID-19 testing. This study explored the validity evidence for a theoretical MCQ-test and checklists developed for nasopharyngeal (NPS) and oropharyngeal (OPS) specimen collection skills assessment. We found good inter-item reliability (Cronbach's alpha = 0.76) for the items of the MCQ-test and high inter-rater reliability using the checklist for the assessment of OPS and NPS skills on 0.86 and 0.87, respectively. The MCQ scores were significantly different between experts (mean 98%) and novices (mean 66%), p < 0.001, and a pass/fail score of 91% was established. We found a significant discrimination between checklist scores of experts (mean 95% score for OPS and 89% for NPS) and novices (mean 50% score for OPS and 36% for NPS), p < 0.001, and a pass/fail score was established of 76% for OPS and 61% for NPS. Further, the results also demonstrated that a group of non-healthcare educated workers can perform upper respiratory tract specimen collection comparably to experts after a short and focused simulation-based training session. This study, therefore, provides validity evidence for the use of a theoretical and practical test for upper respiratory specimens' collection skills that can be used for competency-based training of the workers in the COVID-19 test centers.

[Head and neck ultrasound examination].

Head and neck ultrasound examination is increasingly used as point-of-care imaging among clinicians from different specialities to improve the diagnostic workup and perform ultrasound-guided interventions. Ultrasound can provide immediate information about morphology and anatomic relation of lumps and bumps of the neck and guide treatment of various lesions varying from patients with putative head and neck cancer to patients with acute neck abscess. This review describes the principles of a systematic head and neck ultrasound examination and the most common pathologies diagnoses with benefit by ultrasound.

Content validity evidence for a simulation-based test of handheld otoscopy skills.

PURPOSE: At graduation from medical school, competency in otoscopy is often insufficient. Simulation-based training can be used to improve technical skills, but the suitability of the training model and assessment must be supported by validity evidence. The purpose of this study was to collect content validity evidence for a simulation-based test of handheld otoscopy skills. METHODS: First, a three-round Delphi study was conducted with a panel of nine clinical teachers in otorhinolaryngology (ORL) to determine the content requirements in our educational context. Next, the authenticity of relevant cases in a commercially available technology-enhanced simulator (Earsi, VR Magic, Germany) was evaluated by specialists in ORL. Finally, an integrated course was developed for the simulator based on these results. RESULTS: The Delphi study resulted in nine essential diagnoses of normal variations and pathologies that all junior doctors should be able to diagnose with a handheld otoscope. Twelve out of 15 tested simulator cases were correctly recognized by at least one ORL specialist. Fifteen cases from the simulator case library matched the essential diagnoses determined by the Delphi study and were integrated into the course. CONCLUSION: Content validity evidence for a simulation-based test of handheld otoscopy skills was collected. This informed a simulation-based course that can be used for undergraduate training. The course needs to be further investigated in relation to other aspects of validity and for future self-directed training.

Development and Validation of an Assessment Tool for Technical Skills in Handheld Otoscopy.

OBJECTIVE: Handheld otoscopy requires both technical and diagnostic skills, and is often reported to be insufficient after medical training. We aimed to develop and gather validity evidence for an assessment tool for handheld otoscopy using contemporary medical educational standards. STUDY DESIGN: Educational study. SETTING: University/teaching hospital. SUBJECTS AND METHODS: A structured Delphi methodology was used to develop the assessment tool: nine key opinion leaders (otologists) in undergraduate training of otoscopy iteratively achieved consensus on the content. Next, validity evidence was gathered by the videotaped assessment of two handheld otoscopy performances of 15 medical students (novices) and 11 specialists in otorhinolaryngology using two raters. Standard setting (pass/fail criteria) was explored using the contrasting groups and Angoff methods. RESULTS: The developed Copenhagen Assessment Tool of Handheld Otoscopy Skills (CATHOS) consists 10 items rated using a 5-point Likert scale with descriptive anchors. Validity evidence was collected and structured according to Messick's framework: for example the CATHOS had excellent discriminative validity (mean difference in performance between novices and experts 20.4 out of 50 points, P < .001); and high internal consistency (Cronbach's alpha = 0.94). Finally, a pass/fail score was established at 30 points for medical students and 42 points for specialists in ORL. CONCLUSION: We have developed and gathered validity evidence for an assessment tool of technical skills of handheld otoscopy and set standards of performance. Standardized assessment allows for individualized learning to the level of proficiency and could be implemented in under- and postgraduate handheld otoscopy training curricula, and is also useful in evaluating training interventions. LEVEL OF EVIDENCE: NA.

Protocol for a randomised clinical trial of transoral ultrasound versus standard of care in the diagnosis of peritonsillar abscess.

INTRODUCTION: Peritonsillar infection is a common complication to acute tonsillitis in younger adults. If peritonsillar cellulitis progresses to a peritonsillar abscess (PTA), the primary treatment is surgical drainage. But distinguishing cellulitis from PTA on a standard clinical examination is difficult. This trial aims to explore whether point-of-care transoral ultrasound can improve diagnostic accuracy and guide successful needle aspiration in patients referred with PTA. METHODS: A randomised, controlled multicentre trial will be conducted at the departments of otorhinolaryngology, head and neck surgery at Rigshospitalet and Odense University Hospital. Patients referred with PTA will be randomised to either standard clinical examination (control) or standard clinical examination with supplemental transoral ultrasound (intervention). The diagnostic accuracy, the total number of performed needle aspirations and the proportion of successful needle aspirations will be compared between the two groups. The difference will be evaluated using binary logistic regression and a generalised estimating equation to adjust for clustering of data within each physician and each hospital. A total of 88 patients are necessary to measure the clinical effect of adding transoral ultrasound. CONCLUSIONS: This study will explore the clinical benefits of adding transoral ultrasound to the diagnostic work-up of patients with peritonsillar infections. FUNDING: The Rigshospitalet and Odense University Hospital Foundation. TRIAL REGISTRATION: Clinicaltrials NCT03824288.

Identifying and prioritizing technical procedures in otorhinolaryngology for simulation-based training: a national needs assessment in Denmark.

PURPOSE: To conduct a national needs assessment using a structured approach to identify and prioritize technical skills and procedures in otorhinolaryngology (ORL) for simulation-based training. METHODS: The study was designed as a national Danish survey of key educational stakeholders in ORL. A Delphi methodology with three rounds was used: the first round constituted a brainstorming phase to identify relevant procedures; the second round was a survey of importance, frequency, number of physicians needed to train, and patient safety/discomfort of the procedures, and feasibility of simulation-based training; and a final third round for prioritization. RESULTS: A total of 62 key opinion leaders were identified and 50 responded in the first round, constituting our panel. Fifty technical skills and procedures were identified in the brainstorming phase and were sent out for assessment, with responses from 56.5% of still eligible panellists. Thirty-six procedures were found important in ORL residency training by the panel. After final prioritization by the panel (response rate 43.4%), there was broad consensus (> 75%) on the need for simulation-based training of 13 technical skills and procedures, with the most highly ranking procedures being emergency cricothyroidotomy, flexible fibre pharyngo-laryngoscopy, and basic surgical skills. CONCLUSIONS: As educational decisions are increasingly required to be evidence-based, this study represents a structured approach to identifying procedures for simulation-based training in ORL. This information can be valuable in the development and implementation of simulation-based training programmes in the ORL residency training curriculum.

Procedure-specific assessment tool for flexible pharyngo-laryngoscopy: gathering validity evidence and setting pass-fail standards.

OBJECTIVE: The attainment of specific identifiable competencies is the primary measure of progress in the modern medical education system. The system, therefore, requires a method for accurately assessing competence to be feasible. Evidence of validity needs to be gathered before an assessment tool can be implemented in the training and assessment of physicians. This evidence of validity must according to the contemporary theory on validity be gathered from specific sources in a structured and rigorous manner. The flexible pharyngo-laryngoscopy (FPL) is central to the otorhinolaryngologist. We aim to evaluate the flexible pharyngo-laryngoscopy assessment tool (FLEXPAT) created in a previous study and to establish a pass-fail level for proficiency. METHODS: Eighteen physicians with different levels of experience (novices, intermediates, and experienced) were recruited to the study. Each performed an FPL on two patients. These procedures were video recorded, blinded, and assessed by two specialists. The score was expressed as the percentage of a possible max score. Cronbach's α was used to analyze internal consistency of the data, and a generalizability analysis was performed. The scores of the three different groups were explored, and a pass-fail level was determined using the contrasting groups' standard setting method. RESULTS: Internal consistency was strong with a Cronbach's α of 0.86. We found a generalizability coefficient of 0.72 sufficient for moderate stakes assessment. We found a significant difference between the novice and experienced groups (p < 0.001) and strong correlation between experience and score (Pearson's r = 0.75). The pass/fail level was established at 72% of the maximum score. Applying this pass-fail level in the test population resulted in half of the intermediary group receiving a failing score. DISCUSSION: We gathered validity evidence for the FLEXPAT according to the contemporary framework as described by Messick. Our results support a claim of validity and are comparable to other studies exploring clinical assessment tools. The high rate of physicians underperforming in the intermediary group demonstrates the need for continued educational intervention. CONCLUSION: Based on our work, we recommend the use of the FLEXPAT in clinical assessment of FPL and the application of a pass-fail level of 72% for proficiency.

Diagnostic flexible pharyngo-laryngoscopy: development of a procedure specific assessment tool using a Delphi methodology.

PURPOSE: Proper training and assessment of skill in flexible pharyngo-laryngoscopy are central in the education of otorhinolaryngologists. To facilitate an evidence-based approach to curriculum development in this field, a structured analysis of what constitutes flexible pharyngo-laryngoscopy is necessary. Our aim was to develop an assessment tool based on this analysis. METHODS: We conducted an international Delphi study involving experts from twelve countries in five continents. Utilizing reiterative assessment, the panel defined the procedure and reached consensus (defined as 80% agreement) on the phrasing of an assessment tool. RESULTS: FIFTY PANELISTS COMPLETED THE DELPHI PROCESS. THE MEDIAN AGE OF THE PANELISTS WAS 44 YEARS (RANGE 33-64 YEARS). MEDIAN EXPERIENCE IN OTORHINOLARYNGOLOGY WAS 15 YEARS (RANGE 6-35 YEARS). TWENTY-FIVE WERE SPECIALIZED IN LARYNGOLOGY, 16 WERE HEAD AND NECK SURGEONS, AND NINE WERE GENERAL OTORHINOLARYNGOLOGISTS. AN ASSESSMENT TOOL WAS CREATED CONSISTING OF TWELVE DISTINCT ITEMS.: Conclusion The gathering of validity evidence for assessment of core procedural skills within Otorhinolaryngology is central to the development of a competence-based education. The use of an international Delphi panel allows for the creation of an assessment tool which is widely applicable and valid. This work allows for an informed approach to technical skills training for flexible pharyngo-laryngoscopy and as further validity evidence is gathered allows for a valid assessment of clinical performance within this important skillset.

Competency-based assessment in surgeon-performed head and neck ultrasonography: A validity study.

OBJECTIVE: Head and neck ultrasonography (HNUS) increasingly is used as a point-of-care diagnostic tool by otolaryngologists. However, ultrasonography (US) is a very operator-dependent image modality. Hence, this study aimed to explore the diagnostic accuracy of surgeon-performed HNUS and to establish validity evidence for an objective structured assessment of ultrasound skills (OSAUS) used for competency-based assessment. STUDY DESIGN: A prospective experimental study. METHODS: Six otolaryngologists and 11 US novices were included in a standardized test setup for which they had to perform focused HNUS of eight patients suspected for different head and neck lesions. Their diagnostic accuracy was calculated based on the US reports, and two blinded raters assessed the video-recorded US performance using the OSAUS scale. RESULTS: The otolaryngologists obtained a high diagnostic accuracy on 88% (range 63%-100%) compared to the US novices on 38% (range 0-63%); P < 0.001. The OSAUS score demonstrated good inter-case reliability (0.85) and inter-rater reliability (0.76), and significant discrimination between otolaryngologist and US novices; P < 0.001. A strong correlation between the OSAUS score and the diagnostic accuracy was found (Spearman's ρ, 0.85; P < P 0.001), and a pass/fail score was established at 2.8. CONCLUSION: Strong validity evidence supported the use of the OSAUS scale to assess HNUS competence with good reliability, significant discrimination between US competence levels, and a strong correlation of assessment score to diagnostic accuracy. An OSAUS pass/fail score was established and could be used for competence-based assessment in surgeon-performed HNUS. LEVEL OF EVIDENCE: NA. Laryngoscope, 128:1346-1352, 2018.

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.

Auditory brainstem response - a valid and cost-effective screening tool for vestibular schwannoma?

CONCLUSION: Contemporary auditory brainstem response (ABR) is not valid as a screening tool for VS, when considering the sensitivity of 80%, the specificity of 77%, and the positive predictive value of 3.4%, MRI screening is superior to ABR in Denmark when considering cost-effectiveness. OBJECTIVES: The aim of this study is to assess the sensitivity, specificity, and cost-effectiveness of ABR vs MRI, when screening for VS in a clinical setting. METHOD: Data was collected on all patients subjected to an ABR during a 3-year period (2005-2008) at a tertiary referral center. The data were compared to results of MRI and with data from The Danish National VS Database. In total, 1447 adults underwent ABR, of whom 349 were referred for a subsequent MRI. Sensitivity and specificity were calculated. To assess the cost-effectiveness of ABR vs MRI, procedure costs for ABR and MRI were retrieved from the National Board of Health. RESULTS: Twelve (3.4%) of 349 patients were diagnosed with a VS. Of the 1098 patients not referred for MRI, three (0.3%) were later diagnosed with a VS. The sensitivity and specificity of ABR in diagnosing a VS were 80% and 77%, respectively. Procedure costs were 326 EURO for the ABR and 319 EURO for the MRI.

Preparing for emergency: a valid, reliable assessment tool for emergency cricothyroidotomy skills.

OBJECTIVE: Emergency cricothyrodotomy (EC) is a lifesaving procedure. Evidence-based assessment of training effects and competency levels is relevant to all departments involved in emergency airway management. As most training uses low-fidelity models, the predictive value of good performance on such a model becomes relevant with regard to performance on a high-fidelity model (cadaver). This requires a valid assessment tool for EC performance. STUDY DESIGN: Psychometric study on low-fidelity models and human cadavers. SETTING: University hospital. SUBJECTS AND METHODS: An assessment tool was created. Sixteen physicians (7 experienced surgeons and 9 novice physicians) performed an EC on a low-fidelity model and a cadaver. Two blinded raters assessed video recordings of performances using the assessment tool. RESULTS: We found a high interrater reliability, based on a Pearson's r (0.81), and good evidence for validity, based on successfully distinguishing the 2 groups, using an independent samples t test (P < .001). We found a good correlation between performance on a low-fidelity model and the cadaver with an R (2) = 0.78. CONCLUSION: The tool for assessing EC competence proved reliable and valid. Performance on a low-fidelity model measured this way is a good predictor of performance in a more lifelike situation.