Speech Discrimination Outcomes in Adult Cochlear Implant Recipients by Primary Language and Bilingual Hispanic Patients.

OBJECTIVE: Compare cochlear implant (CI) outcomes in English speakers, Spanish speakers, and bilingual Hispanics. STUDY DESIGN: Retrospective review. SETTING: Academic tertiary care center. METHODS: Eighty-five postlingually deafened adults unilaterally implanted between January 2014 and December 2018 were stratified by primary language. Primary outcomes were: (1) English consonant-nucleus-consonant and Spanish bisyllables word tests in quiet, and (2) English AzBio and Latin American Hearing In Noise Test (LA-HINT) sentence tests in quiet and in noise at multiple time-intervals postactivation. RESULTS: In the respective languages, primary Spanish speakers (n = 24), and English speakers (n = 61) experienced the greatest increases in average scores for word and sentence tests in quiet during the first 6 months postactivation, with gradual increases in average scores over time. English speakers performed significantly worse on AzBio tests in noise, compared to quiet, while the addition of noise did not significantly affect average LA-HINT scores in Spanish speakers across multiple time intervals. An early ceiling effect was also demonstrated for LA-HINT. Although not significant, bilingual Hispanics (n = 12) had lower average AzBio in quiet scores than English speakers and higher average LA-HINT in quiet scores than the Spanish speakers across multiple time intervals. CONCLUSION: English and Spanish CI users experienced the greatest increases in speech understanding in quiet the first few months after implant activation. An early ceiling effect is demonstrated with LA-HINT, indicating LA-HINT is not appropriate for evaluating longitudinal CI outcomes in Spanish speakers. Bilingual Hispanics represent a unique group, and further investigations are necessary to understand speech perception patterns in both languages and develop the best CI test strategies for these individuals.

Comparison of Speech Test Outcomes After Cochlear Implantation in Patients With and Without Asymmetric Hearing Loss.

OBJECTIVES: Determine whether asymmetric hearing loss (AHL) affects postoperative speech outcomes in cochlear implant (CI) patients. STUDY DESIGN: Retrospective cohort study. SETTING: Tertiary care hospital. PATIENTS: Adult English-speaking patients with unilateral CIs implanted between 2014 and 2018 were stratified into NonAHL and AHL groups based on preoperative AzBio scores in quiet from the nonimplanted ear (0-50% vs. 51-100%, respectively). INTERVENTIONS: CI surgery in the poorer performing ear. MAIN OUTCOME MEASURES: Postoperative consonant-nucleusconsonant (CNC) word and AzBio sentence test scores in quiet and/or noise at +5 dB signal-to-noise ratio (SNR). RESULTS: Of 512 patients, 33 non-AHL and 27 AHL patients were included. Average ages were 65.6 and 63.6 years, respectively. As expected, preoperative AzBio scores in quiet from the nonimplanted ear were higher in the AHL group (95% confidence interval [95%CI]: 66.4-76.4%) than the non-AHL group at baseline (95%CI: 12.3-23.6%). In both cohorts, AzBio scores in quiet from the implanted ear improved from baseline, with 24-month scores (95%CI: 73.8 - 84.9%) being higher than preoperative scores (95%CI: 13.2-23.1%). There were also significant differences in AzBio scores in quiet between cohorts overall (p  = 0.0120) on mixed model analysis, with the AHL group performing ∼6.4% better than the non-AHL group; however, differences were not significant when scores were stratified by time. In addition, there were no significant differences in CNC in quiet and AzBio scores in noise at +5 dB SNR between cohorts (p  = 0.1786 and p  = 0.6215, respectively). CONCLUSIONS: After CI, patients with AHL can achieve scores on word and sentence tests at least comparable to traditional CI candidates, supporting the expansion of CI candidacy to include patients with AHL.

Real-world biologic and apremilast treatment patterns in patients with psoriasis and psoriatic arthritis.

PURPOSE: Real-world treatment patterns among psoriasis patients with and without psoriatic arthritis (PsA) newly initiating treatment with a biologic or apremilast were assessed. PATIENTS AND METHODS: MarketScan claims data from adults with psoriasis and ?1 new prescription for secukinumab, adalimumab, ustekinumab, etanercept, or apremilast from January 1, 2015, to August 31, 2018, were assessed for adherence, switching, and combination therapy by index medication and PsA diagnosis. RESULTS: At treatment initiation, 22.0%-45.7% of patients had PsA. Over 24 months, discontinuation rates were high (34.4%-54.6%) overall and higher in patients with versus without PsA (all P<0.05 except secukinumab). Adherence was poor (16.8%-34.8%); switching and combination therapy were common. CONCLUSION: Treatment patterns varied, with better outcomes in PsA patients receiving anti-tumor necrosis factor versus anti-IL17/IL12/23 agents.

Direct and indirect economic burden associated with rotator cuff tears and repairs in the US.

OBJECTIVE: This retrospective study examined treatment characteristics and the economic burden associated with rotator cuff tears (RCT) and rotator cuff repairs (RCR). Additionally, this study aimed to explore the economic implications associated with delayed surgical intervention. METHODS: Adult RCT patients meeting eligibility criteria were identified from 1/1/2013-6/30/2017 using the IBM Watson Health MarketScan Commercial database. Patients with incident RCR within 12 months post-index and 12 months continuous enrollment after the RCR date were also analyzed. Early surgery was defined as RCR within 6 months and 1 month from the partial-thickness tear and full-thickness tear diagnoses, respectively. Patient characteristics, all-cause direct costs (plan paid and patient out-of-pocket), RCT-related costs, pre-surgical costs, post-surgical costs, and healthcare resource utilization were reported by RCT type. Attributable indirect costs, absenteeism and short-term disability (STD), were also estimated. RESULTS: 102,488 RCT patients were identified (partial-thickness tears: 46,856 [45.7%]; full-thickness tears: 55,632 [54.3%]). Fifty per cent RCT patients underwent RCR within 12-months of diagnosis. Full-thickness RCT patients had an average total baseline (one year pre-diagnosis) and post-index costs of $17,096 and $32,110, respectively. Similarly, partial thickness patients had baseline costs of $16,385 and post-index costs of $27,017. Mean all-cause annual post-surgery costs were $34,086 for patients with partial-thickness tears and $34,249 for patients with full-thickness tears, of which 40% and 38% of costs were RCT-related, respectively. Productivity losses due to absenteeism and STD in the 12-month post-surgery period averaged $5843 and $4493, respectively, for partial-thickness tear patients and $5770 and $4382, respectively, for full-thickness tear patients. Average additional spending per delayed surgical patient between diagnosis and surgery was $8524 and $3213 (both p <0.001) for partial- and full-thickness tear patients, respectively. CONCLUSIONS: This exploratory analysis indicates considerable RCT and RCR economic burden to the healthcare system. High healthcare utilization and costs highlight the importance of efficiently managing patients with RCT diagnosis. Data also suggest that early surgical intervention may be economically beneficial if surgical intervention is anticipated post-RCT.

Real-world Comorbidity Burden, Health Care Utilization, and Costs of Nonalcoholic Steatohepatitis Patients With Advanced Liver Diseases.

GOALS: This study evaluates the real-world comorbidity burden, health care resource utilization (HRU), and costs among nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH) patients with advanced liver diseases [compensated cirrhosis (CC), decompensated cirrhosis (DCC), liver transplantation (LT), hepatocellular carcinoma (HCC)]. BACKGROUND: NAFLD/NASH is a leading cause of liver diseases. MATERIALS AND METHODS: Adult NAFLD/NASH patients were identified retrospectively from MarketScan Commercial claims (2006-2016). Following initial NAFLD/NASH diagnosis, advanced liver diseases were identified using the first diagnosis as their index date. Mean annual all-cause HRU and costs (2016 USD) were reported. Adjusted costs were estimated through generalized linear models. Cumulative costs were illustrated for patient subsets with variable follow-up for each stage. RESULTS: Within the database, 485,774 NAFLD/NASH patients met eligibility criteria. Of these, 93.4% (453,564) were NAFLD/NASH patients without advanced liver diseases, 1.6% (7665) with CC, 3.3% (15,833) with DCC, 0.1% (696) with LT, and 0.1% (428) with HCC. Comorbidity burden was high and increased as patients progressed through liver disease severity stages. Compared with NAFLD/NASH without advanced liver diseases (adjusted costs: $23,860), the annual cost of CC, DCC, LT, and HCC were 1.22, 5.64, 8.27, and 4.09 times higher [adjusted costs: $29,078, $134,448, $197,392, and $97,563 (P<0.0001)]. Inpatient admissions significantly drove increasing HRU. CONCLUSION: Study findings suggest the need for early identification and effective management of NAFLD/NASH patients to minimize comorbidity burden, HRU, and costs in the privately insured US population.

Switching to Progressively Reduced Nicotine Content Cigarettes in Smokers With Low Socioeconomic Status: A Double-Blind Randomized Clinical Trial.

INTRODUCTION: The Food and Drug Administration issued an advanced notice of proposed rulemaking for setting a product standard for nicotine levels in cigarettes, with an emphasis on minimally or non-addicting very low nicotine content (VLNC). METHODS: A 33 week, two-arm, double-blind randomized trial conducted in Hershey, Pennsylvania, USA and Washington, DC, USA included adult daily cigarette smokers (≥5 cigarettes per day) with less than a college degree, and who had no plans to quit within the next six months. Participants were randomized to either reduced nicotine content (RNC) study cigarettes tapered every three weeks to a final VLNC (0.2 mg/cigarette) for six weeks or to usual nicotine content (UNC) study cigarettes (11.6 mg/cigarette). Outcomes included acceptability of study cigarettes measured by attrition (primary outcome), compliance, reduction in cigarette dependence and tobacco biomarkers, and post-intervention cessation. RESULTS: The RNC (n = 122) versus UNC (n = 123) group had higher attrition (adjusted Hazard Ratio 3.4; 95% confidence interval [CI] 1.99 to 5.81). At the end of the intervention, cotinine levels were 50% lower in the RNC group (mean group difference -137 ng/mL; 95% CI -172, -102). The RNC group smoked fewer CPD (-4.1; 95% CI -6.44, -1.75) and had lower carbon monoxide levels (-4.0 ppm; 95% CI -7.7, -0.4). Forty seven percent (29/62) of the RNC group were biochemically-confirmed compliant with smoking VLNC cigarettes (mean cotinine = 8.9 ng/ml). At three month follow-up, only compliant VLNC smokers quit with an assisted quit attempt (N = 6/22, 27%). CONCLUSIONS: This study supports a VLNC standard in cigarettes. IMPLICATIONS: Differential dropout and noncompliance indicate some smokers had difficulty transitioning to cigarettes with reduced nicotine. These smokers will benefit from supplemental nicotine in medicinal or noncombustible tobacco products if a nicotine reduction standard is established. Other smokers successfully transitioned to very low nicotine content cigarettes exclusively and substantially reduced their exposure to nicotine.

Clinical trial recruitment of adult African American smokers from economically disadvantaged urban communities.

This investigation evaluated the effectiveness and challenges of multiple recruitment methods, described as proactive, reactive, and combination methods, among adult African American smokers (N = 527) from economically disadvantaged urban communities enrolled to test progressively reduced nicotine content investigational cigarettes. The study evaluated success using descriptive statistics to measure the volume of phone calls and percentage of eligible participants per method. Reactive and combination strategies effectively prompted participants to call about the study. Combination methods yielded the highest eligibility rates. Findings demonstrate the unique recruitment successes within this population across a range of recruitment methods and may inform improved methods to recruit and engage African Americans in clinical trials.

Reduced nicotine content cigarettes in smokers of low socioeconomic status: study protocol for a randomized control trial.

BACKGROUND: The Family Smoking Prevention and Tobacco Control Act gave the Food and Drug Administration jurisdiction over the regulation of all tobacco products, including their nicotine content. Under this act, a major strategy to reduce harm from cigarette tobacco is lowering the nicotine content without causing unintended adverse consequences. Initial research on reduced nicotine content (RNC) cigarettes has shown that smokers of these cigarettes gradually decrease their smoking frequency and biomarkers of exposure. The effectiveness of this strategy needs to be demonstrated in different populations whose response to RNC cigarettes might be substantially mediated by personal or environmental factors, such as low socioeconomic status (SES) populations. This study aims to evaluate the response to a reduced nicotine intervention in low SES smokers, as defined here as those with less than 16 years of education, by switching smokers from high nicotine commercial cigarettes to RNC cigarettes. METHODS/DESIGN: Adults (N = 280) who have smoked five cigarettes or more per day for the past year, have not made a quit attempt in the prior month, are not planning to quit, and have less than 16 years of education are recruited into a two-arm, double-blinded randomized controlled trial. First, participants smoke their usual brand of cigarettes for 1 week and SPECTRUM research cigarettes containing a usual amount of nicotine for 2 weeks. During the experimental phase, participants are randomized to continue smoking SPECTRUM research cigarettes that contain either (1) usual nicotine content (UNC) (11.6 mg/cigarette) or (2) RNC (11.6 to 0.2 mg/cigarette) over 18 weeks. During the final phase of the study, all participants are offered the choice to quit smoking with nicotine replacement therapy, continue smoking the research cigarettes, or return to their usual brand of cigarettes. The primary outcomes of the study include retention rates and compliance with using only research cigarettes and no use of other nicotine-containing products. Secondary outcomes are tobacco smoke biomarkers, nicotine dependence measures, smoking topography, stress levels, and adverse health consequences. DISCUSSION: Results from this study will provide information on whether low SES smokers can maintain a course of progressive nicotine reduction without increases in incidence of adverse effects. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01928719 . Registered on 21 August 2013.

Safety analysis of occupational exposure of healthcare workers to residual contaminations of cytotoxic drugs using FMECA security approach.

Handling cytotoxic drugs is associated with chemical contamination of workplace surfaces. The potential mutagenic, teratogenic and oncogenic properties of those drugs create a risk of occupational exposure for healthcare workers, from reception of starting materials to the preparation and administration of cytotoxic therapies. The Security Failure Mode Effects and Criticality Analysis (FMECA) was used as a proactive method to assess the risks involved in the chemotherapy compounding process. FMECA was carried out by a multidisciplinary team from 2011 to 2016. Potential failure modes of the process were identified based on the Risk Priority Number (RPN) that prioritizes corrective actions. Twenty-five potential failure modes were identified. Based on RPN results, the corrective actions plan was revised annually to reduce the risk of exposure and improve practices. Since 2011, 16 specific measures were implemented successively. In six years, a cumulative RPN reduction of 626 was observed, with a decrease from 912 to 286 (-69%) despite an increase of cytotoxic compounding activity of around 23.2%. In order to anticipate and prevent occupational exposure, FMECA is a valuable tool to identify, prioritize and eliminate potential failure modes for operators involved in the cytotoxic drug preparation process before the failures occur.

Clinical, surgical, and electrical factors impacting residual hearing in cochlear implant surgery.

CONCLUSIONS: This study recommends using soft surgical principal and round window insertion to protect residual hearing with favorable anatomical exposure. Further studies are needed to evaluate the impact of the electrical stimulation on the organ of corti and hearing. OBJECTIVE: The objective of this study is to analyze various factors that impact on preservation of residual hearing post-implantation. METHODS: A retrospective study was performed to analyze loss of residual hearing in a cohort of 225 patients implanted in a large academic center. Sixty-four patients met the inclusion criteria. The impact of age at implantation, gender, etiology of hearing loss, cochleostomy vs round window insertion, partial vs full insertion, and effect of initial stimulation were analyzed using appropriate statistical analysis. RESULTS: The overall hearing preservation rate for all implanted patients was 64%. Loss of residual hearing was significantly more observed in cases of cochleostomy and/or non-soft surgical techniques. No correlation was observed with age at implantation, gender, side of implant, device manufacturer, and presence of pre-lingual deafness vs post-lingual, full or partial electrode insertion. In addition, there was a small but significant decrease in hearing between pre-stimulation and post-stimulation audiograms at 6000 Hz.

Risk Profiles of Youth Single, Dual, and Poly Tobacco Users.

INTRODUCTION: Given widespread availability and uptake of myriad tobacco products among youth, a comprehensive tobacco control agenda necessitates an in-depth exploration of the phenomenon of concurrent tobacco use. METHODS: Multinomial logistic regression generated distinct concurrent tobacco use risk profiles of single, dual, and poly use, defined as use of only one, only two, and any three or more tobacco products in the last 30 days, from the 2012 National Youth Tobacco Survey (n = 24 658). RESULTS: Among youth using tobacco in the past 30 days (n = 5030), the majority were poly tobacco product users (55.9%, n = 2813), followed by single (28.4%, n = 1406), and dual users (16.1%, n = 811). Multivariable models showed higher levels of nicotine dependence among poly users compared to single (relative risk ratio [RRR] = 3.14, P < .001) and dual users (RRR = 2.48, P < .001). Poly users were less likely to express quit intent compared to single (RRR = 0.68, P < .01) or dual users (RRR = 0.77, P < .05). Tobacco harm perceptions were more likely among dual users relative to single product users (RRR = 1.54, P < .05); poly users were less likely to perceive harm (RRR = 0.56, P < .001). Racial and gender differences also emerged. CONCLUSION: As the number of tobacco products increased, nicotine dependence and perceived tobacco use among peers increased, whereas quit intentions decreased. Dual users had greater tobacco harm perceptions than poly and single users and higher prevalence of electronic cigarette use. Results suggest that poly use may be driven by addiction whereas dual use may be motivated by intentions to quit. Focused risk assessments may inform tailored interventions for distinct types of tobacco users. IMPLICATIONS: This study provides an in-depth look at the risks for concurrent tobacco use among youth by creating unique risk profiles for single, dual and poly use. Results from this study can inform tailored interventions for distinct types of tobacco users.

The Effect of Changes in Health Beliefs Among African-American and Rural White Church Congregants Enrolled in an Obesity Intervention: A Qualitative Evaluation.

Church interventions can reduce obesity disparities by empowering participants with knowledge and skills within an established community. The purpose of this study was to evaluate the Biomedical/Obesity Reduction Trial (BMORe) and investigate changes in health beliefs among obese adult participants. Ten pre-/post-intervention focus groups applying the Health Belief Model conducted in two African-American churches in Tennessee (n = 20) and South Carolina (n = 20), and one rural Appalachian church in Kentucky (n = 21). Two independent coders using NVivo analyzed transcribed audio data and notes. Participants' health status of being overweight/obese and having comorbidities of diabetes and high blood pressure motivated enrollment in BMORe. Initially participants voiced low self-efficacy in cooking healthy and reading food labels. BMORe made participants feel "empowered" after 12 weeks compared to initially feeling "out of control" with their weight. Participants reported improvements in emotional health, quality of life, and fewer medications. During post-intervention focus groups, participants reported increased self-efficacy through family support, sharing healthy eating strategies, and having accountability partners. Solidarity and common understanding among BMORe participants led focus group attendees to comment how their peers motivated them to stay in the program for 12 weeks. Long-term barriers include keeping the weight off by maintaining habits of exercise and healthy eating. Implementation of pre-/post-intervention focus groups is an innovative approach to evaluate an obesity intervention and track how changes in health beliefs facilitated behavior change. This novel approach shows promise for behavioral interventions that rely on participant engagement for sustained effectiveness.