Developing Script Concordance Test Items in Otolaryngology to Improve Clinical Reasoning Skills: Validation using Consensus Analysis and Psychometrics.

Background: Script concordance testing is widely practiced to foster and assess clinical reasoning. Our study aimed to develop script concordance test (SCT) in the specialty of otolaryngology and test the validation using panel response pattern and consensus index. Materials and Methods: The methodology was an evolving pattern of constructing SCTs, administering them to the panel members, and optimizing the panel with response patterns and consensus index. The SCT's final items were chosen to be administered to the students. Results: We developed 98 items of SCT and administered them to 20 panel members. The mean score of the panel members for these 98 items was 79.5 (standard deviation [SD] = 4.4). The consensus index calculated for the 98-item SCT ranged from 25.81 to 100. Sixteen items had bimodal and uniform response patterns; the consensus index improved when eliminated. We administered the rest 82 items of SCT to 30 undergraduate and ten postgraduate students. The mean score of undergraduate students was 61.1 (SD = 7.5) and that of postgraduate students was 67.7 (SD = 6.3). Cronbach's alpha for the 82-item SCT was 0.74. Excluding the 22 poor items, the final SCT instrument of 60 items had a Cronbach's alpha of 0.82. Conclusion: Our study revealed that a consensus index above 60 had a good item-total correlation and be used to optimize the items for panel responses in SCT, necessitating further studies on this aspect. Our study also revealed that the panel response clustering pattern could be used to categorize the items, although bimodal and uniform distribution patterns need further differentiation.

A Prospective, Randomized, Double-Blind Study on the Efficacy of Different Modes of Topical Application of Nasal Anesthetics in the Diagnostic Nasal Endoscopy Procedure.

Introduction In the current otorhinolaryngology practice, technology has always been an essential part. Therefore, diagnostic nasal endoscopy (DNE) has become a vital examination in today's practice. In order to visualize the nasal cavity in a systematic manner without any discomfort to both patient and doctor, the nose should be well anesthetized and decongested. Objective The study is to compare and evaluate the efficacy of 4% lignocaine-oxymetazoline cotton pledget packing versus topical sprays in the preparation of nasal cavities for DNE. Methodology The prospective, randomized, double-blind study was conducted among 246 patients and was divided into two groups. In the first group, the nose was packed with cotton pledgets containing 4% lignocaine-oxymetazoline and another group with 4% lignocaine-oxymetazoline spray. Following DNE, patients and surgeons were questioned on a pre-formed questionnaire to evaluate their experience during the procedure. Results It was observed that the time taken for the pre-endoscopic preparation of the packing group was more than the spray group. A total of 91.9% of the spray group had pain during the pre-endoscopic preparation and more burning and tingling sensation than in the nasal pack (75.6%). A total of 69.9% of the patients among the spray group participants compared to 32.5% of the packing group patients experienced more throat discomfort. In addition, 12% of the packing group had mucosal bleeding during the preparation. A total of 32.5% of the spray group experienced severe pain when compared to 12.2% of the packing group during the endoscopic procedure. Most of the participants from both groups had difficulty visualizing the superior turbinate and sphenoethmoidal recess during the procedure. There was a significant difference seen between both the groups with respect to pain during the pre-endoscopic procedure (p=0.0005), burning/tingling sensation (p<0.0001), throat pain (<0.0001), mucosal bleed (p=0.0003), pain during the procedure (p=0.0001), and discomfort after the procedure (p<0.0001). Conclusion Both methods of nasal preparation have merits and demerits in terms of discomfort, pain, and visualization of structures. Still, the packing of the nasal cavity with cotton pledgets is better when compared to spraying with 4% lignocaine-oxymetazoline. However, 4% lignocaine-oxymetazoline spray can be used during an emergency situation and with sensitive patients.

Hedgehog inhibitors with and without adjunctive therapy in treatment of locally advanced basal cell carcinoma.

BACKGROUND: Hedgehog inhibitor therapy (HHIT) is considered first-line treatment for locally advanced, unresectable basal cell carcinoma (laBCC). HHIT often results in a partial response, which requires adjunctive therapy (AT) post HHIT. We present real-world data for laBCCs undergoing HHIT ± AT. METHODS: Retrospective review at Duke University from 11/01/2007 through 5/20/2020 revealed 13 patients treated with systemic HHIT (sonidegib or vismodegib) for laBCC. RESULTS: Fourteen laBCCs were identified in 13 patients. LaBCCs were treated with sonidegib (n = 10, 71%) or vismodegib (n = 4, 29%) for a median (IQR) of 9.4 (9.3) or 9.8 (8.5) months, respectively. The median (IQR) follow-up time from HHIT initiation was 15.5 (8.7) months. Tumors were most often located on the trunk (43%), followed by head and neck (29%), extremities (21%), and orbit/periorbital area (7%). Nine laBCCs (64%) were treated with HHIT alone, of which five (36%) achieved complete response (CR), four (29%) achieved partial response (PR), and five (36%) achieved CR with combined HHIT and AT post-HHIT. Duration of HHIT treatment (IQR) was 7.5 (3.5) months in the 10 CR patients, versus 15.1 (6.3) months in the four PR patients (P = 0.024). Nine patients (69%) experienced adverse events from HHIT, most commonly ageusia/dysgeusia, muscle spasms, and alopecia. CONCLUSION: As a single institutional experience, we report 10/14 laBCCs (71%) with CRs without recurrence and 4/14 laBCCs (29%) with PRs with HHIT ± AT over median follow-up of 15.5 months. Longer follow-up and larger cohorts evaluating responses with HHIT followed by AT are needed to substantiate our findings.

The utility of initial staging PET-CT as a baseline scan for surveillance imaging in stage II and III melanoma.

BACKGROUND: This study evaluates the utility of whole-body PET-CT for the initial staging and subsequent surveillance imaging of patients with completely resected stage II and stage III melanoma. METHODS: A single-center, retrospective review of patients who received perioperative whole-body PET-CT from January 1, 2005 to December 1, 2019 within three months of initial melanoma diagnosis was performed. RESULTS: Of 258 total patients with completely resected melanoma who had a PET-CT within 3 months after their melanoma diagnosis, 113 had stage II and 145 had stage III melanoma. PET-CT detected distant metastasis in 3 (2.7%) of 113 stage II patients and 7 (4.8%) of 145 stage III patients. 179 of 258 patients had adequate follow-up time to determine whether they received surveillance cross-sectional imaging and whether they had a melanoma recurrence. 143 (79.9%) received subsequent surveillance imaging, 74 of whom developed a recurrence. In 64 (86.5%) of 74 cases, recurrence was detected by routine surveillance. 26 (34.2%) of 76 stage II and 65 (63.1%) of 103 stage III patients developed a recurrence. The median time to recurrence among the 179 patients for stage II and III was 16.3 and 13.0 months, respectively. CONCLUSIONS: These findings indicate that baseline staging with whole-body PET-CT rarely provides information that changes initial management. Rather, the value of the initial PET-CT is as a baseline for subsequent surveillance scans. Therefore, it may be premature to discourage cross-sectional imaging for patients with stage II and III melanoma without supportive evidence or a reliable biomarker of recurrent disease.

Higher BMI, But Not Sarcopenia, Is Associated With Pembrolizumab-related Toxicity in Patients With Advanced Melanoma.

BACKGROUND/AIM: To determine whether BMI and sarcopenia were related to treatment-limiting toxicity or efficacy of pembrolizumab treatment in melanoma patients. PATIENTS AND METHODS: Medical records for melanoma patients undergoing pembrolizumab treatment at Duke University from January 2014 to September 2018 were reviewed. Pre-treatment measurements such as BMI were collected. Pre-treatment CT imaging was used to determine psoas muscle index (PMI). Patients in the lowest sex-specific tertile of PMI were sarcopenic. Logistic regression measured associations with treatment toxicity and response. Kaplan-Meier analysis assessed progression-free survival (PFS) and overall survival (OS). RESULTS: Among 156 patients, the overall objective response rate was 46.2% and 29 patients (18.6%) experienced treatment-limiting toxicity. Sarcopenia was not significantly associated with toxicity, response, or survival. However, obese patients (BMI >30) experienced higher rates of toxicity (p=0.0007). CONCLUSION: Sarcopenia did not appear to predict clinically relevant outcomes. Obesity, however, represents a readily available predictor of pembrolizumab toxicity.

Retreatment with talimogene laherparepvec for advanced melanoma.

Aim: Talimogene laherparepvec (T-VEC) is a genetically modified oncolytic herpesvirus approved for the treatment of unresectable, locoregionally advanced and recurrent melanoma. There is little relevant literature in the context of retreatment with T-VEC. Materials & methods: We reviewed four patients aged 71-87 years old with stage IIIB-IV melanoma at treatment who were rechallenged with T-VEC after experiencing recurrence of locoregional disease or prior treatment-limiting toxicity. Results: Cessation of initial treatment was due to one of the following reasons: severe adverse event (one case), mixed response (one case) or complete response (two cases). Three males and one female underwent T-VEC retreatment with a mean of 5.5 injection cycles. Three patients experienced a complete response to retreatment, while one experienced disease progression. Conclusion: Intralesional T-VEC may be effective and well-tolerated in patients who have completed prior T-VEC therapy.

Diagnostic delay for head and neck cancer in South India: A Mixed-methods Study.

BACKGROUND: Early diagnosis is an important aspect of quality of cancer care.Analysis of the diagnostic delays and the reasons for delay helps to plan strategies to improve cancer care. OBJECTIVES: To determine the primary, secondary, and total diagnostic delay of patients diagnosed with head and neck cancer and to explore the reasons for the delay from the patient perspective. METHODS: Explanatory mixed method design was used. Two hundred persons with a confirmed diagnosis of head and neck cancer attending the ENT (ear, nose, throat) cancer clinic in a teaching hospital before the initiation of treatment were included in the study. The median delay and the association of the delay with the various factors were analyzed. Sixteen one-to-one interviews of patients were done to identify the reasons for the delays from the patient perspective. RESULTS: Median primary, secondary, and total diagnostic delays were 30 days, 30 days, and 73 days, respectively. Statistically, primary delay was found significantly longer among ever users of smokeless tobacco and significantly longer secondary delay was found among those with age less than 60 years. The reasons for the delay were grouped in the categories (i) Symptom appraisal delay due to low perceived seriousness and (ii) health-seeking behavior delay. CONCLUSIONS: The diagnostic delay was considerable. Measures to enhance symptom appraisal by improving health literacy, opportunistic screening, and strengthening the referral system would decrease diagnostic delay.

Validity and Reliability of Tamil translated University of Washington Quality of Life Questionnaire for Head and Neck Cancers.

BACKGROUND: Quality of life is an important outcome measure used both in research and patient care across all cultural healthcare settings. OBJECTIVE: This study is aimed to evaluate the validity and reliability of interviewer-administered Tamil translated University of Washington Quality of Life Questionnaire (Version 4) in a setting with low literacy. METHODS: The study was done in a tertiary care teaching institute in Puducherry, South India. The translation was done by using 'forward-backward translation method.' A hundred subjects diagnosed with head and neck cancer (HNC) were interviewed before the initiation of treatment. The Tamil version of University of Washington Quality of Life Questionnaire (UWQOL) questionnaire was validated using the Tamil version of the World Health Organization Quality of Life-Brief questionnaire (WHOQOL-BREF) version. Inter-rater reliability and test-retest reliability was also assessed. Item-total correlation and Cronbach alpha were calculated for assessing validity and internal consistency respectively. RESULTS: In the Tamil version of UWQOL, social-emotional subscale was more affected than physical subscale. The domains such as mood, anxiety, and pain were most affected. The subscale scores were significantly different between those with early and late cancer. Tamil version of UWQOL showed moderate correlation with WHOQOL-BREF. The Tamil version of UWQOL had good test-retest and inter-rater agreement. Item-total correlation for the subscales was >0.80. The internal consistency of the Tamil Questionnaire was acceptable with Cronbach Alpha of 0.69. CONCLUSION: The Tamil version of UWQOL questionnaire is a short, valid and reliable for HNC patients of low literacy.