Clinical validation of a saliva-based matrix metalloproteinase-1 rapid strip test for detection of oral cavity cancer.

BACKGROUND: We previously identified matrix metalloproteinase-1 (MMP-1) as one of the most promising salivary biomarkers for oral squamous cell carcinoma (OSCC) and developed a sensitive ELISA for MMP-1 with good performance in detection of OSCC using a cohort of 1160 saliva samples. METHODS: A time-saving rapid strip test (RST) for MMP-1 was developed in this study and its diagnostic performance compared with ELISA using saliva samples from a new cohort of 603 subjects (171 healthy controls, 236 patients with oral potentially malignant disorders, and 196 OSCC patients). RESULTS: Salivary MMP-1 levels measured using RST and ELISA were highly comparable and both assays could effectively distinguish between OSCC and non-cancerous groups. Similar to ELISA, receiver operating characteristic curve analysis of the MMP-1 RST was effective in identifying patients with OSCC at different oral cavity sites and stages. CONCLUSIONS: Salivary MMP-1 can be sensitively detected using both RST and ELISA methods. Our newly developed point-of-care MMP-1 RST is a promising in vitro diagnostic device (IVD) that may serve as a novel auxiliary tool in the routine clinical detection and monitoring of OSCC.

The Development and Evaluation of a Smartphone-Aided Diagnosis Application to Measure Tympanic Membrane Perforations.

OBJECTIVES: Chronic otitis media is a long-term infection of the middle ear. It is characterized by persistent discharge from the middle ear through a perforated tympanic membrane. It is one of the most common causes of preventable hearing loss, especially in developing countries. Precise estimation of the size of tympanic membrane perforation is essential for successful clinical management. In this study, we developed a smartphone-based application to calculate the ratio of the area of tympanic membrane perforation to the area of the tympanic membrane. Twelve standardized patients and 60 medical students were involved to assess the area of tympanic membrane perforation, in particular, the percentage of perforation size. METHODS: In total, 60 student doctors (including year 5 and year 6 medical students, intern and post-graduate year training of doctors) were recruited during their rotation at the Otolaryngology department of Taipei Medical University Shuang-Ho Hospital. Twelve standardized patients with chronic otitis media were recruited through a single otology practice. Oto-endoscopic examination was performed for all patients by using a commercially-available digital oto-endoscope, and clinical images of the tympanic membrane perforation were obtained. To demonstrate the variability of perforation size estimation by different student doctors, we calculated the percentage of perforation using the smartphone-based application for 12 tympanic membranes objectively and compared the results with those visually estimated by the 60 student doctors subjectively. RESULTS: The variance in the visual estimation by the 60 student doctors was large. By contrast, variances in smartphone-based application calculations were smaller, indicating consistency in the results obtained from different users. The smartphone-based application accurately estimated the presence of perforation for tympanic membranes with high consistency. The differences in visual estimations can be considerably great and the variances can be large among different individuals. CONCLUSIONS: The smartphone-based application is a dependable tool for precisely evaluating the size of tympanic membrane perforation.

Validation of a Personalized Hearing Screening Mobile Health Application for Persons with Moderate Hearing Impairment.

Hearing impairment is a frequent human sensory impairment. It was estimated that over 50% of those aged >75 years experience hearing impairment in the United States. Several hearing impairment-related factors are detectable through screening; thus, further deterioration can be avoided. Early identification of hearing impairment is the key to effective management. However, hearing screening resources are scarce or inaccessible, underlining the importance of developing user-friendly mobile health care systems for universal hearing screening. Mobile health (mHealth) applications (apps) act as platforms for personalized hearing screening to evaluate an individual's risk of developing hearing impairment. We aimed to evaluate and compare the accuracy of smartphone-based air conduction and bone conduction audiometry self-tests with that of standard air conduction and bone conduction pure-tone audiometry tests. Moreover, we evaluated the use of smartphone-based air conduction and bone conduction audiometry self-tests in conductive hearing loss diagnosis. We recruited 103 patients (206 ears) from an otology clinic. All patients were aged ≥20 years. Patients who were diagnosed with active otorrhea was excluded. Moderate hearing impairment was defined as hearing loss with mean hearing thresholds >40 dB. All patients underwent four hearing tests performed by a board-certified audiologist: a smartphone-based air conduction audiometry self-test, smartphone-based bone conduction audiometry self-test, standard air-conduction pure-tone audiometry, and standard bone conduction pure-tone audiometry. We compared and analyzed the results of the smartphone-based air conduction and bone conduction audiometry self-tests with those of the standard air conduction and bone conduction pure-tone audiometry tests. The sensitivity of the smartphone-based air conduction audiometry self-test was 0.80 (95% confidence interval CI = 0.71-0.88) and its specificity was 0.84 (95% CI = 0.76-0.90), respectively. The sensitivity of the smartphone-based bone conduction audiometry self-test was 0.64 (95% CI = 0.53-0.75) and its specificity was 0.71 (95% CI = 0.62-0.78). Among all the ears, 24 were diagnosed with conductive hearing loss. The smartphone-based audiometry self-tests correctly diagnosed conductive hearing loss in 17 of those ears. The personalized smartphone-based audiometry self-tests correctly diagnosed hearing loss with high sensitivity and high specificity, and they can be a reliable screening test to rule out moderate hearing impairment among the population. It provided patients with moderate hearing impairment with personalized strategies for symptomatic control and facilitated individual case management for medical practitioners.

Can Face- and Smartphone-Touching Behaviors Be Altered with Personal Hygiene Reminders during the COVID-19 Pandemic Period? An Observational Study.

As part of the new measures to prevent the spread of the 2019 coronavirus disease (COVID-19), medical students were advised to wear a mask in class and avoid touching their faces. Few studies have analyzed the influence of health education on the frequency of face- and smartphone-touching behaviors during the COVID-19 pandemic. This research compared the frequency of in-class face- and smartphone-touching behaviors of medical students before and after the delivery of personal hygiene education during the COVID-19 pandemic. A behavioral observational study was conducted involving medical students at Taipei Medical University. Eighty medical students were recruited during a lecture on otorhinolaryngology. All medical students were required to wear a mask. Their face- and smartphone-touching behavior was observed by viewing the 4 k resolution video tape recorded in class. The recording lasted for 2 h, comprising 1 h prior to the health educational reminder and 1 h afterwards. The frequencies of hand-to-face contact and hand-to-smartphone contact were analyzed before and after the delivery of health education emphasizing personal hygiene. Comprehensive health education and reminders effectively reduce the rate of face- and smartphone-touching behaviors.

Verification of Saliva Matrix Metalloproteinase-1 as a Strong Diagnostic Marker of Oral Cavity Cancer.

Oral squamous cell carcinoma (OSCC) accounts for >90% of cases of oral cancer, including cancer at the lip and oral cavity and cancer at the oropharynx. Most OSCCs develop from oral potentially malignant disorders (OPMDs), which consist of heterogeneous lesions with different malignant transformation potentials that make early detection of OSCC a challenge. Using a targeted mass spectrometry-based assay to compare multiple candidate proteins, we previously identified matrix metalloproteinase-1 (MMP-1) as one of the most promising salivary OSCC biomarkers. To explore the clinical utility of MMP-1 in OSCC detection, we developed an in-house, sensitive enzyme-linked immunosorbent assay (ELISA) for measuring MMP-1 content, and tested it on saliva samples from 1160 subjects (313 healthy controls, and 578 OPMD and 269 OSCC patients) collected at two medical centers. Salivary MMP-1 levels measured by our in-house ELISA significantly discriminated OSCC patients from non-cancerous groups. A receiver operating characteristic curve analysis showed that MMP-1 was effective in separating non-cancer groups from patients with OSCCs at the oral cavity. Additionally, salivary MMP-1 levels in oral cavity cancer patients were highly correlated with tumor progression (tumor size, lymph node metastasis, and overall stage). Collectively, our results indicate that salivary MMP-1 is an effective biomarker for OSCC that can be sensitively detected using our newly developed ELISA. The newly developed MMP-1 ELISA may be used as a new adjunctive tool to aid in detecting and monitoring OSCC.