Assessment of the impact of XP-Endo Finisher file on push-out bond strength of various endodontic sealers.

Background: An endodontic treatment is considered a success after thorough chemomechanical debridement coupled with obturating root canals in a concrete way thereby providing hermetic seal. Gutta-percha being nonadherent necessitates use of a sealer to achieve hermetic seal. Adequate adhesion of root canal sealer with gutta-percha core and radicular dentin ensures lack of apical leakage. Materials and Methods: Sixty extracted mandibular premolars with single root canal decoronated at cementoenamel junction were selected and randomly allocated to two groups (n = 30). Samples in Group 1 were prepared with BT Race file, while Group 2 samples were prepared with BT Race alongwith XP Endo file. Absorbent paper points were used for canal drying and samples were randomly divided into six subgroups. In Subgroup I, obturation was done with bio-ceramic (BC) sealer (Endosequence BC) and BC gutta-percha. In Subgroup II, resin-based (AH plus) sealer and gutta-percha were used. In Subgroup III, calcium hydroxide-based (Sealapex) sealer and gutta-percha were used. Sectioning of root samples was done perpendicularly into coronal, middle, and apical segments of 3 mm each. A universal testing machine was used for sample testing, in which push-out bond strength corresponded to the highest value obtained. Stereomicroscopic (×20) study of the samples determined the failure mode at dentin/sealer/main cone interface. Statistical Analysis: Analysis of variance and post hoc Tukey's tests were used for data analysis. Results: Endosequence BC with XP-Endo files showed the highest mean push-out bond strength (16.31 MPa), whereas Sealapex without XP-Endo file had the lowest values (12.76 MPa). Mixed failure of adhesive and cohesive mode was observed for most samples. Conclusion: Adjunctive irrigation agitation technique utilizing XP-Endo Finisher facilitates biofilm eradication from difficult niches in root canals, thereby improving adhesion of sealer and subsequently the sealer bond strength.

Computing the Cost of Care per Patient per Day for Patients With Metastatic Neuroendocrine Neoplasms.

PURPOSE: Patients with well-differentiated, low-grade metastatic neuroendocrine neoplasms (NENs) usually have a long median survival and require complex, expensive care over many years at multidisciplinary centers. The cost burden for patients and institutions serves as a barrier to care. Understanding the drivers of these costs and whether intense monitoring adds value will help to optimize value-based care. METHODS: We adapted the cost of care per patient per day (CCPD) validated methodology to measure cost while accounting for varying follow-up duration. We queried the Stanford NEN Database, which aggregates data from the electronic health record and other electronic sources, to study patients with metastatic NENs receiving regular care at Stanford. Current Procedural Terminology codes for services incurred during the monitoring period for each patient were mapped to the corresponding cost conversion factor and date in the Medicare fee schedule. RESULTS: Two hundred two patients between 2010 and 2017 were studied with a mean CCPD of $119.11 in US dollars (USD); NEN-specific systemic therapy made up 55% of this cost. Somatostatin analogs were the costliest systemic therapy. Systemic therapy was the driver of cost differences among patients with various primary tumor types, stage of disease, tumor differentiation and grade, and functional hormone status. Patients in the most expensive CCPD group did not have a significant survival benefit (P = .66). CONCLUSION: The CCPD methodology was effective in studying cancer care value in NENs. Systemic therapy, specifically somatostatin analogs, was the primary driver of cost, and intense monitoring and higher-cost care did not improve survival outcomes.

Optimizing disease progression assessment using blinded central independent review and comparing it with investigator assessment in the PRIMA/ENGOT-ov26/GOG-3012 trial: challenges and solutions.

OBJECTIVE: Progression-free survival is an established clinically meaningful endpoint in ovarian cancer trials, but it may be susceptible to bias; therefore, blinded independent centralized radiological review is often included in trial designs. We compared blinded independent centralized review and investigator-assessed progressive disease performance in the PRIMA/ENGOT-ov26/GOG-3012 trial examining niraparib monotherapy. METHODS: PRIMA/ENGOT-ov26/GOG-3012 was a randomized, double-blind phase 3 trial; patients with newly diagnosed stage III/IV ovarian cancer received niraparib or placebo. The primary endpoint was progression-free survival (per Response Evaluation Criteria in Solid Tumors [RECIST] v1.1), determined by two independent radiologists, an arbiter if required, and by blinded central clinician review. Discordance rates between blinded independent centralized review and investigator assessment of progressive disease and non-progressive disease were routinely assessed. To optimize disease assessment, a training intervention was developed for blinded independent centralized radiological reviewers, and RECIST refresher training was provided for investigators. Discordance rates were determined post-intervention. RESULTS: There was a 39% discordance rate between blinded independent centralized review and investigator-assessed progressive disease/non-progressive disease in an initial patient subset (n=80); peritoneal carcinomatosis was the most common source of discordance. All reviewers underwent training, and as a result, changes were implemented, including removal of two original reviewers and identification of 10 best practices for reading imaging data. Post-hoc analysis indicated final discordance rates between blinded independent centralized review and investigator improved to 12% in the overall population. Median progression-free survival and hazard ratios were similar between blinded independent centralized review and investigators in the overall population and across subgroups. CONCLUSION: PRIMA/ENGOT-ov26/GOG-3012 highlights the need to optimize blinded independent centralized review and investigator concordance using early, specialized, ovarian-cancer-specific radiology training to maximize validity of outcome data.

Field-friendly MUNNG® optima simple test kit for quick qualitative assessment of iodine and iron presence in double-fortified salt.

Background: Data from several efficacy studies and a long-term effectiveness study have encouraged the governments to adopt a policy of providing double-fortified salt (DFS) in the Mid-Day Meal (MDM) programs in government schools across India. These envisaged food security events are likely to boost the manufacturing of DFS in a big way. Thus, it becomes pertinent to come up with a robust monitoring system involving community and field workers for quality checks. It is imperative to equip these field workers with simple testing kits (STKs) capable of qualitative detection of iron and iodine in DFS. As the consumer acceptance of foods is based on several factors including sensory characteristics, performance, convenience, cost, nutrition, and product image, a variety of iron compounds are in use for fortification. However, it becomes challenging to provide a kit that can overcome the chemical masking of iodine detection by iron compounds. Objectives: We aimed at (1) the development of a field-friendly STK for quick qualitative assessment of iodine and various forms of iron present in DFS, (2) to check its validity under field conditions. Methods: We put in place reagents combined using known chemical reactions and balanced use of oxidants to overcome the problems of encapsulation and to maximize the use, by enabling reagent combination to react with all forms of iron. Results: The kit reagents successfully detect iodine as well as three commonly used iron fortificants in DFS. Published field trials confirmed the specificity and sensitivity of the developed kit. The simplicity and use of the kit by a field worker can be seen in the enclosed video. Conclusion: The combination of improvised kit reagents allows early detection of iron and iodine in DFS. Iron is detected in a variety of iron-containing fortifications. The provision of diluted H2O2 ensures the presence of oxygen-free radicals that enhances iodine release captured by concentrated KI making iodine detection an easy task.

Racial and Ethnic Differences in Presentation and Outcomes for Patients Hospitalized With COVID-19: Findings From the American Heart Association's COVID-19 Cardiovascular Disease Registry.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has exposed longstanding racial and ethnic inequities in health risks and outcomes in the United States. We aimed to identify racial and ethnic differences in presentation and outcomes for patients hospitalized with COVID-19. METHODS: The American Heart Association COVID-19 Cardiovascular Disease Registry is a retrospective observational registry capturing consecutive patients hospitalized with COVID-19. We present data on the first 7868 patients by race/ethnicity treated at 88 hospitals across the United States between January 17, 2020, and July 22, 2020. The primary outcome was in-hospital mortality. Secondary outcomes included major adverse cardiovascular events (death, myocardial infarction, stroke, heart failure) and COVID-19 cardiorespiratory ordinal severity score (worst to best: death, cardiac arrest, mechanical ventilation with mechanical circulatory support, mechanical ventilation with vasopressors/inotrope support, mechanical ventilation without hemodynamic support, and hospitalization alone. Multivariable logistic regression analyses were performed to assess the relationship between race/ethnicity and each outcome adjusting for differences in sociodemographic, clinical, and presentation features, and accounting for clustering by hospital. RESULTS: Among 7868 patients hospitalized with COVID-19, 33.0% were Hispanic, 25.5% were non-Hispanic Black, 6.3% were Asian, and 35.2% were non-Hispanic White. Hispanic and Black patients were younger than non-Hispanic White and Asian patients and were more likely to be uninsured. Black patients had the highest prevalence of obesity, hypertension, and diabetes. Black patients also had the highest rates of mechanical ventilation (23.2%) and renal replacement therapy (6.6%) but the lowest rates of remdesivir use (6.1%). Overall mortality was 18.4% with 53% of all deaths occurring in Black and Hispanic patients. The adjusted odds ratios for mortality were 0.93 (95% CI, 0.76-1.14) for Black patients, 0.90 (95% CI, 0.73-1.11) for Hispanic patients, and 1.31 (95% CI, 0.96-1.80) for Asian patients compared with non-Hispanic White patients. The median odds ratio across hospitals was 1.99 (95% CI, 1.74-2.48). Results were similar for major adverse cardiovascular events. Asian patients had the highest COVID-19 cardiorespiratory severity at presentation (adjusted odds ratio, 1.48 [95% CI, 1.16-1.90]). CONCLUSIONS: Although in-hospital mortality and major adverse cardiovascular events did not differ by race/ethnicity after adjustment, Black and Hispanic patients bore a greater burden of mortality and morbidity because of their disproportionate representation among COVID-19 hospitalizations.

Cost-Effectiveness of Initial Versus Delayed Lanreotide for Treatment of Metastatic Enteropancreatic Neuroendocrine Tumors.

BACKGROUND: The Controlled Study of Lanreotide Antiproliferative Response in Neuroendocrine Tumors (CLARINET) trial showed prolonged progression-free survival in patients initially treated with lanreotide versus placebo. We evaluated the cost-effectiveness of upfront lanreotide versus active surveillance with lanreotide administered after progression in patients with metastatic enteropancreatic neuroendocrine tumors (NETs), both of which are treatment options recommended in NCCN Clinical Practice Guidelines in Oncology for Neuroendocrine and Adrenal Tumors. METHODS: We developed a Markov model calibrated to the CLARINET trial and its extension. We based the active surveillance strategy on the CLARINET placebo arm. We calculated incremental cost-effectiveness ratios (ICERs) in dollars per quality-adjusted life-year (QALY). We modeled lanreotide's cost at $7,638 per 120 mg (average sales price plus 6%), used published utilities (stable disease, 0.77; progressed disease, 0.61), adopted a healthcare sector perspective and lifetime time horizon, and discounted costs and benefits at 3% annually. We examined sensitivity to survival extrapolation and modeled octreotide long-acting release (LAR) ($6,183 per 30 mg). We conducted one-way, multiway, and probabilistic sensitivity analyses. RESULTS: Upfront lanreotide led to 5.21 QALYs and a cost of $804,600. Active surveillance followed by lanreotide after progression led to 4.84 QALYs and a cost of $590,200, giving an ICER of $578,500/QALY gained. Reducing lanreotide's price by 95% (to $370) or 85% (to $1,128) per 120 mg would allow upfront lanreotide to reach ICERs of $100,000/QALY or $150,000/QALY. Across a range of survival curve extrapolation scenarios, pricing lanreotide at $370 to $4,000 or $1,130 to $5,600 per 120 mg would reach ICERs of $100,000/QALY or $150,000/QALY, respectively. Our findings were robust to extensive sensitivity analyses. The ICER modeling octreotide LAR is $482,700/QALY gained. CONCLUSIONS: At its current price, lanreotide is not cost-effective as initial therapy for patients with metastatic enteropancreatic NETs and should be reserved for postprogression treatment. To be cost-effective as initial therapy, the price of lanreotide would need to be lowered by 48% to 95% or 27% to 86% to reach ICERs of $100,000/QALY or $150,00/QALY, respectively.

Sex differences in eligibility for advanced heart failure therapies.

OBJECTIVES: We investigated sex-based differences in eligibility for and outcomes after receipt of advanced heart failure (HF) therapies. BACKGROUND: Although women are more likely to die from HF than men, registry data suggest that women are less likely to receive heart transplant (HT) or left ventricular assist device (LVAD) for largely unknown reasons. METHODS: We performed a single-center retrospective cohort study of patients evaluated for advanced HF therapies from 2012 to 2016. Logistic regression was used to determine the association of sex with eligibility for HT/LVAD. Competing risks and Kaplan-Meier analysis were used to examine survival. RESULTS: Of 569 patients (31% women) evaluated, 223 (39.2%) were listed for HT and 81 (14.2%) received destination (DT) LVAD. Women were less likely to be listed for HT (adjusted odds ratio [OR] 0.36, 95% confidence interval [CI] 0.21-0.61; P < .0001), based on allosensitization (P < .0001) and obesity (P = .02). Women were more likely to receive DT LVAD (adjusted OR 2.29, 95% CI 1.23-4.29; P = .01). Survival was similar between men and women regardless of whether they received HT and DT LVAD or were ineligible for therapy. CONCLUSION: Women are less likely to be HT candidates, but more likely to receive DT LVAD.

Racial differences in the development of de-novo donor-specific antibodies and treated antibody-mediated rejection after heart transplantation.

BACKGROUND: Despite improvements in outcomes after heart transplantation, black recipients have worse survival compared with non-black recipients. The source of such disparate outcomes remains largely unknown. We hypothesize that a propensity to generate de-novo donor-specific antibodies (dnDSA) and subsequent antibody-mediated rejection (AMR) may account for racial differences in sub-optimal outcomes after heart transplant. In this study we aimed to determine the role of dnDSA and AMR in racial disparities in post-transplant outcomes. METHODS: This study was a single-center, retrospective analysis of 137 heart transplant recipients (81% male, 48% black) discharged from Emory University Hospital. Patients were classified as black vs non-black for the purpose of our analysis. Kaplan-Meier and Cox regression analyses were used to evaluate the association between race and selected outcomes. The primary outcome was the development of dnDSA. Secondary outcomes included treated AMR and a composite of all-cause graft dysfunction or death. RESULTS: After 3.7 years of follow-up, 39 (28.5%) patients developed dnDSA and 19 (13.8%) were treated for AMR. In multivariable models, black race was associated with a higher risk of developing dnDSA (hazard ratio [HR] 3.65, 95% confidence interval [CI] 1.54 to 8.65, p = 0.003) and a higher risk of treated AMR (HR 4.86, 95% CI 1.26 to 18.72, p = 0.021) compared with non-black race. Black race was also associated with a higher risk of all-cause graft dysfunction or death in univariate analyses (HR 2.10, 95% CI 1.02 to 4.30, p = 0.044). However, in a multivariable model incorporating dnDSA, black race was no longer a significant risk factor. Only dnDSA development was significantly associated with all-cause graft dysfunction or death (HR 4.85, 95% CI 1.89 to 12.44, p = 0.001). CONCLUSION: Black transplant recipients are at higher risk for the development of dnDSA and treated AMR, which may account for racial disparities in outcomes after heart transplantation.

Disparities in Gynecological Malignancies.

OBJECTIVES: Health disparities and inequalities in access to care among different socioeconomic, ethnic, and racial groups have been well documented in the U.S. healthcare system. In this review, we aimed to provide an overview of barriers to care contributing to health disparities in gynecological oncology management and to describe site-specific disparities in gynecologic care for endometrial, ovarian, and cervical cancer. METHODS: We performed a literature review of peer-reviewed academic and governmental publications focusing on disparities in gynecological care in the United States by searching PubMed and Google Scholar electronic databases. RESULTS: There are multiple important underlying issues that may contribute to the disparities in gynecological oncology management in the United States, namely geographic access and hospital-based discrepancies, research-based discrepancies, influence of socioeconomic and health insurance status, and finally the influence of race and biological factors. Despite the reduction in overall cancer-related deaths since the 1990s, the 5-year survival for Black women is significantly lower than for White women for each gynecologic cancer type and each stage of diagnosis. For ovarian and endometrial cancer, black patients are less likely to receive treatment consistent with evidence-based guidelines and have worse survival outcomes even after accounting for stage and comorbidities. For cervical and endometrial cancer, the mortality rate for black women remains twice that of White women. CONCLUSION: Health care disparities in the incidence and outcome of gynecologic cancers are complex and involve biologic factors as well as racial, socioeconomic, and geographic barriers that influence treatment and survival. These barriers must be addressed to provide optimal care to women in the U.S. with gynecologic cancer.

Impact of socio-economic status on ear health and behaviour in children: A cross-sectional study in the capital of India.

INTRODUCTION: Socio-economic differences in the society have been a major cause for the discrepancy in disease and behavioural patterns in society. With 360 million people (32 million children) in the world suffering from disabling hearing losses, it is imperative to gain an insight into the impact of differences in socio-economic strata on children's ear health issues, their knowledge of ear ailments and attitude towards ear health so as to suggest policies addressing ear health issues. METHODS: The study was carried out in two different school types namely government schools and private schools which represent wide difference in the socio-economic status of the students studying there. A questionnaire was administered to students aged 10 to 13 years to assess the current ear care practices, knowledge regarding ear ailments, attitude towards hearing and their adaptability to reform. RESULTS: The children belonging to higher socio-economic status were found to have lesser incidence of ear diseases and ear abuse, more referrals for ear ailments, lesser indulgence in risky ear health behaviours, better knowledge pool, positive attitude towards ear health and hearing and were more adaptable to change for better hearing. CONCLUSION: Structures of social disparity are essential determinants of ear health acting both independently and through their influence on behavioural determinants of health. Increasing awareness of ear health issues at the school level itself should be one of the goals of health care providers.