Virtual versus usual in-office care for multiple sclerosis: The VIRTUAL-MS multi-site randomized clinical trial study protocol.

BACKGROUND: Multiple sclerosis (MS) affects nearly 1 million people and is estimated to cost $85.4 billion in the United States annually. People with MS have significant barriers to receiving care and telemedicine could substantially improve access to specialized, comprehensive care. In cross-sectional analyses, telemedicine has been shown to be feasible, have high patient and clinician satisfaction, reduce patient costs and burden, and enable a reasonable assessment of disability. However, no studies exist evaluating the longitudinal impact of telemedicine care for MS. Here we describe the study protocol for VIRtual versus UsuAL In-office care for Multiple Sclerosis (VIRTUAL-MS). The main objective of the study is to evaluate the impact of telemedicine for MS care on: patient clinical outcomes, economic costs, patient, and clinician experience. METHODS: This two-site randomized clinical trial will enroll 120 adults with a recent diagnosis of MS and randomize 1:1 to receive in-clinic vs. telemedicine care for 24 months. The primary outcome of the study is worsening in any one of the four Multiple Sclerosis Functional Composite 4 (MSFC4) measures at 24 months. Other study outcomes include patient and clinician satisfaction, major healthcare costs, Expanded Disability Status Scale, treatment adherence, and digital outcomes. CONCLUSION: The results of this study will directly address the key gaps in knowledge about longitudinal telemedicine-enabled care in an MS population. It will inform clinical care implementation as well as design of trials in MS and other chronic conditions. TRIAL REGISTRATION: NCT05660187.

Emergency department visits and emergency-to-inpatient admissions for abnormal uterine bleeding in the USA nationwide.

BACKGROUND: Abnormal uterine bleeding (AUB) is a common but understudied gynaecological problem, and data are lacking on emergency department (ED) visits and associated ED-to-inpatient admissions for AUB. This project aims to further understanding of the burden of AUB on patients and the healthcare system by establishing the number and characteristics of women with AUB in the ED and evaluating predictors of AUB-related inpatient hospitalisation in the USA. METHODS: This is a cross-sectional study of women presenting to the ED with non-malignant AUB in the 2016 US Nationwide Emergency Department Sample (NEDS). Clinical, demographic and hospital system factors were evaluated. χ2 and Mann-Whitney tests were used to compare the proportion of visits with each characteristic, resulting in inpatient admission versus discharge from the ED. Multivariable logistic regression models were used to analyse predictors of AUB in the ED and of AUB-related hospitalisations. RESULTS: There were 1.03 million AUB-related visits in the 2016 NEDS, of which 11.2% resulted in inpatient admission. Clinical as well as demographic and hospital system factors influenced ED disposition. Women with AUB tended to be of reproductive age, be underinsured, live in lower income and urban areas, and present to urban and public hospitals. However, older age, higher income, better insurance, presentation to private hospitals and rural residence predicted inpatient admission. CONCLUSIONS: Our study highlights the ED as an essential place of care for women with AUB while also demonstrating the importance of access to outpatient gynaecology services as some AUB-related ED visits may be preventable with outpatient care. The significant demographic and hospital system differences, as well as expected clinical differences, between women with AUB admitted to inpatient and women discharged from the ED imply structural biases impacting AUB-related ED care and add to the deepening understanding of health disparities.

A Measurement-Based Protocol Improves Interrater Agreement and Accuracy of Right Ventricular Systolic Pressure Assessment by Echocardiography in Children: A Call for Quality Improvement.

BACKGROUND: Echocardiographic measurements carry the promise of improving interrater (IR) agreement over subjective assessment. The aim of this study was to assess the effect of implementing a measurement-based protocol on IR agreement and accuracy in reporting of right ventricular (RV) systolic pressure in children. The effect of this reporting protocol on IR agreement in reporting RV dilation, hypertrophy, and systolic function was also evaluated. METHODS: Five echocardiography readers reported their assessment of RV systolic pressure, dilation, hypertrophy, and systolic function on 40 deidentified echocardiograms using their individual accustomed methods and then using an agreed-upon protocol based solely on RV measurements. IR agreement was assessed using κ statistics. Accuracy of RV systolic pressure ratings was assessed using the McNemar test in comparison with hemodynamic data obtained by cardiac catheterization. The reliability of the RV measurements was assessed using intraclass correlation coefficient (ICC) and coefficient of variation. RESULTS: IR agreement and accuracy of RV systolic pressure assessment improved after using the measurement-based protocol (agreement from 0.39 [95% CI, 0.27-0.5] to 0.62 [95% CI, 0.48-0.76] and accuracy from 18 of 40 to 29 of 40 [P = .03]). IR agreement of RV dilation improved (from 0.36 [95% CI, 0.25-0.48] to 0.63 [95% CI, 0.48-0.79]), while IR agreement of RV hypertrophy (from 0.29 [95% CI, 0.17-0.42] to 0.35 [95% CI, 0.15-0.55]) and RV systolic function (from 0.57 [95% CI, 0.45-0.69] to 0.53 [95% CI, 0.41-0.66]) did not improve. The reliability of the measurements was good (ICC > 0.8), except for RV free wall thickness (ICC = 0.62, coefficient of variation = 24%) and RV fractional area change (ICC = 0.47, coefficient of variation = 22%), suggesting a possible reason for the lack of improvement in IR agreement of RV hypertrophy and RV systolic function. Heteroscedasticity was observed in the reliability of RV measurements, with the ICC being significantly lower at larger magnitudes for all RV measurements. CONCLUSIONS: Standardization of reporting protocols using RV measurements in place of subjective assessment improved IR agreement and accuracy of RV systolic pressure assessment. Reliable measurements (RV systolic pressure and dilation) resulted in improvement in IR agreement while unreliable measurements (RV hypertrophy and systolic function) did not. Special attention to measurements' reliability and heteroscedasticity of reliability is required when designing clinical protocols to decrease IR disagreement as a source of error.

Improved Tumor Control Related to Radiotherapy Technological Development for Hypopharyngeal Cancer.

OBJECTIVES/HYPOTHESIS: Squamous cell carcinoma of the hypopharynx (SCCHP) is associated with worse survival compared to other head and neck subsites. This report quantifies the impact of technological improvements in radiotherapy (RT) on outcomes over 6 decades. METHODS: Patients with SCCHP receiving curative-intent treatment between 1962 and 2015 were retrospectively reviewed. Kaplan-Meier analyses of freedom from local recurrence (FFLR), progression-free survival (PFS), and overall survival (OS) were compared across treatment eras and radiation techniques. Multivariable Cox proportional hazards modeling was performed to specify the effect of RT technique. RESULTS: One hundred thirty-four patients had a median follow-up of 17 months (IQR = 9-38). There were no differences in staging or use of surgery over time, but use of chemotherapy concurrent with RT increased (P < .001) beginning in the 2000s. The 24-month FFLR using two-dimensional RT (2D-RT), three-dimensional conformal RT (3D-CRT), and intensity-modulated RT (IMRT) was 52%, 55%, and 80%, respectively; 24-month PFS was 39%, 46%, and 73%, respectively; and 24-month OS was 27%, 40%, and 68%, respectively. OS (P = .01), PFS (P = .03), and FFLR (P = 0.02) were improved with IMRT over 2D-RT, and FFLR appeared to be improved over 3D-CRT (P = .06). Controlling for chemotherapy use and other major variables, IMRT produced a strong influence over FFLR (adjusted hazard ratio [HR] = 0.2, 95% confidence interval [CI]: 0.0-1.2, P = .08) and a benefit in OS (adjusted HR = 0.1, 95% CI: 0.0-0.4, P = .005). CONCLUSIONS: Across 6 decades, patient and tumor characteristics remained similar whereas use of chemoradiation increased and IMRT was adopted. The introduction of IMRT was associated with improved FFLR, PFS, and OS, and a reduction in acute toxicity as compared to earlier radiation technologies. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:E452-E458, 2021.

Use of otoacoustic emissions to improve outcomes and reduce disparities in a community preschool hearing screening program.

INTRODUCTION: Hearing loss substantially impacts pediatric development, and early identification improves outcomes. While intervening before school-entry is critical to optimize learning, early-childhood hearing screening practices are highly variable. Conditioned play audiometry (CPA) is the gold standard for preschool hearing screening, but otoacoustic emission (OAE) testing provides objective data that may improve screening outcomes. OBJECTIVES: To compare outcomes of a community-based low-income preschool hearing program before and after implementation of OAE in a single-visit, two-tiered paradigm. We hypothesized that this intervention would reduce referral rates and improve follow-up while maintaining stable rates of diagnosed sensorineural hearing loss. METHODS: We performed a cohort study of 3257 children screened from July 2014-June 2016. Department of Public Health data were analyzed pre- and post-implementation of second-line OAE testing for children referred on CPA screening with targeted follow-up by DPH staff. Primary outcomes included referral rates, follow-up rates, and diagnosis of sensorineural hearing loss. RESULTS: Demographics, pure-tone pass rates, and incidence of newly-diagnosed permanent hearing loss were similar across years. After intervention, overall pass rates increased from 92% to 95% (P = 0.0014), while only 0.7% remained unable to be tested (P<0.0001). 5% of children were unable to be tested by CPA screening but passed OAE testing, obviating further evaluation. Referral rate decreased from 8% to 5% (P = 0.0014), and follow-up improved from 36% to 91% (P<0.0001). Identification of pathology in children with follow-up increased from 19% to over 50%. Further, disparities in pass rates and ability to test seen in Year 1 were eliminated in Year 2. CONCLUSION AND RELEVANCE: In a community setting, implementation of second-line OAE screening for CPA referrals reduced referral rates, increased identification of hearing loss, reduced outcome disparities, and improved follow-up rates. This study provides lessons in how to improve outcomes and reduce disparities in early-childhood hearing screening.

Oral Health Care of Vietnamese Adolescents: A Qualitative Study of Perceptions and Practices.

PURPOSE: To explore the oral health perceptions and practices of Vietnamese adolescents 13 to 17 years old in San Jose, Calif. METHODS: A purposeful sample of 10 Vietnamese parents with adolescent children were recruited at a Temple in San Jose, Calif. After gaining parental consent and adolescent assent, Vietnamese adolescents participated in an audio-taped, 20 to 30 minute, individual, semi-structured interview in English to explore their perceptions about oral health. Interview data were transcribed verbatim. All statements related to each question were identified, and similar statements were grouped into categories. RESULTS: Ten adolescents participated in the study. All reported tooth appearance as the most important reason for oral care, and that oral health, diet and general health were related. All were concerned about dental pain. Of the respondents, 9 believed that having good teeth would give them more confidence, and help them find jobs and romantic partners, while 2 did not follow recommended oral hygiene routines or recognize early signs of disease. Seven participants favored U.S. dentists over Vietnamese dentists. Frequently reported barriers to seeking dental care were fear of dental treatment (n=7) and inability to pay for dental care (n=6). CONCLUSION: When educating Vietnamese adolescents, dental hygienists need to highlight availability of pain control, encourage better performance of personal oral hygiene and recommend dental clinics with sliding fee scales to low-income families. This approach to oral health education may enhance dental health and seeking of regular dental visits.

Assessment of pathology instruction in U.S. Dental hygiene educational programs.

PURPOSE: To assess the instruction of pathology content in entry-level and advanced practitioner dental hygiene educational programs and the program directors' perceptions whether their graduates are adequately prepared to meet the increasingly complex medical and oral health needs of the public. METHODS: A 28-question survey of instructional content and perceptions was developed and distributed using Qualtrics® software to the 340 directors of entry-level and advanced practitioner dental hygiene programs in the US. Respondents rated their level of agreement to a series of statements regarding their perceptions of graduates' preparation to perform particular dental hygiene services associated with pathology. Descriptive statistics for all 28 categorical survey questions were calculated and presented as the frequency (percentage). RESULTS: Of the 340 directors surveyed, 130 (38%) responded. Most entry-level respondents (53%) agreed or strongly agreed (29%) that their graduates were adequately prepared to meet the complex medical and oral health needs of the public, while all respondents of advanced practitioner programs strongly agreed. More respondents strongly agreed to statements related to clinical instruction than to didactic courses. While 64% of respondents agreed that their graduates were prepared to practice unsupervised, if it were legally allowed, 21% were ambivalent. The extent of pathology instruction in entry-level programs varied, but most used traditional formats of instruction, educational resources and assessments of educational outcomes. Advanced practitioner programs emphasized histological and clinical examination of oral lesions and patient case studies. CONCLUSION: Strengthening pathology instruction would ensure that future generations of dental hygienists would be adequately prepared to treat medically compromised patients.

Prediction of survival after liver retransplantation for late graft failure based on preoperative prognostic scores.

The current policy for determining priority for organ allocation is based on the model for end stage liver disease (MELD). We hypothesize that severity of graft dysfunction assessed by either the MELD score or the Child-Turcotte-Pugh (CTP) score correlates with mortality after liver retransplantation (re-OLT). To test this hypothesis, we analyzed the outcome of 40 consecutive patients who received re-OLT more than 90 days after primary orthotopic liver transplantation (OLT). The Kaplan-Meier 1-year and 5-year survival rates after re-OLT were 69% and 62%, respectively. The area under the curve (AUC) values generated by the receiver operating characteristics (ROC) curves were 0.82 (CI 0.70-0.94) and 0.68 (CI 0.49-0.86), respectively (P =.11), for the CTP and MELD models in predicting 1-year mortality after re-OLT. The 1-year and 5-year survival rates for patients with CTP scores less than 10 were 100% versus 50% and 40%, respectively, for CTP scores of at least 10 (P =.0006). Patients with MELD scores less than or equal to 25 had 1-year and 5-year survival rates of 89% and 79%, respectively, versus 53% and 47%, respectively, for MELD scores greater than 25 (P =.038). Other mortality predictors include hepatic encephalopathy, intensive care unit (ICU) stay, recurrent hepatitis C virus (HCV) infection, and creatinine level of 2 mg/dL or higher. Analysis of an independent cohort of 49 patients showed a trend for a correlation between CTP and MELD scores with 1-year mortality, with AUC of 0.59 and 0.57, in respective ROC curves. In conclusion, our results suggest that severity of graft failure based on CTP and MELD scores may be associated with worse outcome after re-OLT and provide a cautionary note for the "sickest first" policy of organ allocation.