bluuebunny/crossref_metadata_2025 huggingface dataset:
Intra-operative nasal compression after lateral osteotomy to minimize post-operative Peri-orbital ecchymosis and edema
Authors: Sowerby L. , Kim L. M. , Chow W. , Moore C.
Published: October 2019

Introduction

Post-operative periorbital ecchymosis and edema following rhinoplasty is a well-known sequela of surgery. Unfortunately, this can be a source of distress for patients, resulting in a longer post-operative recovery time and a delayed return to work. Trauma caused by lateral osteotomies is likely the most significant cause of periorbital edema and ecchymosis in rhinoplasty. There have been various strategies proposed to minimize swelling and ecchymosis with varying success rates and accompanied risks. Intraoperative nasal compression is one potential strategy that may reduce post-operative edema and ecchymosis with minimal risk.

Objective

To determine whether applying direct lateral nasal pressure intraoperatively immediately after performing lateral osteotomies reduces visible post-operative edema and ecchymosis.

Methods

A prospective, randomized blinded study on consecutive patients undergoing rhinoplasty with lateral osteotomies was conducted in a single academic tertiary care medical center. Each of the participants were randomized into direct pressure application post-lateral osteotomies on the right or the left hand side. Intra-operatively, direct lateral nasal pressure was performed on the pre-determined side for 5 min timed by stopwatch after osteotomy. Post-operatively, standard photographs were taken of the patient on post-operative days 1, 3, and 7. These photographs were then shown to 20 blinded-physicians and the degree of ecchymosis and edema was graded using a previously published scale.

Results

A total of 16 patients were included in this study. Based on our blinded-grading, 11 of the 16 patients had a clear global improvement in the degree of peri-orbital post-operative edema and ecchymosis with compression post lateral osteotomies. Based on the 3 blinded expert reviewers, Periorbital ecchymosis was significantly decreased on the ipsilateral side of pressure application in 10 of the 16 patients, and periorbital edema was significantly decreased in 13 of the 16 patients. The differential degree in periorbital ecchymosis was most pronounced on post-operative day 7. Patient factors such as gender, age, skin color, history of nasal trauma, side of pre-operative nasal deviation, and smoking status did not have a significant influence on the effect of pressure application post lateral osteotomies.

Conclusions

Application of direct continual lateral nasal pressure intraoperatively after performing lateral osteotomies can help reduce post-operative edema and ecchymosis up to post-operative day 7. This may lead to an overall improved appearance and subsequently an improved post-operative experience for the patient. Although the effect may be variable to some degree, this is an intervention with no additional risks involved and thus can be used in a safe manner.
Capture at the single cell level of metabolic modules distinguishing aggressive and indolent glioblastoma cells
Authors: Saurty-Seerunghen Mirca S. , Bellenger Léa , El-Habr Elias A. , Delaunay Virgile , Garnier Delphine , Chneiweiss Hervé , Antoniewski Christophe , Morvan-Dubois Ghislaine , Junier Marie-Pierre
Published: October 2019

Glioblastoma cell ability to adapt their functioning to microenvironment changes is a source of the extensive intra-tumor heterogeneity characteristic of this devastating malignant brain tumor. A systemic view of the metabolic pathways underlying glioblastoma cell functioning states is lacking. We analyzed public single cell RNA-sequencing data from glioblastoma surgical resections, which offer the closest available view of tumor cell heterogeneity as encountered at the time of patients’ diagnosis. Unsupervised analyses revealed that information dispersed throughout the cell transcript repertoires encoded the identity of each tumor and masked information related to cell functioning states. Data reduction based on an experimentally-defined signature of transcription factors overcame this hurdle. It allowed cell grouping according to their tumorigenic potential, regardless of their tumor of origin. The approach relevance was validated using independent datasets of glioblastoma cell and tissue transcriptomes, patient-derived cell lines and orthotopic xenografts. Overexpression of genes coding for amino acid and lipid metabolism enzymes involved in anti-oxidative, energetic and cell membrane processes characterized cells with high tumorigenic potential. Modeling of their expression network highlighted the very long chain polyunsaturated fatty acid synthesis pathway at the core of the network. Expression of its most downstream enzymatic component, ELOVL2, was associated with worsened patient survival, and required for cell tumorigenic properties in vivo. Our results demonstrate the power of signature-driven analyses of single cell transcriptomes to obtain an integrated view of metabolic pathways at play within the heterogeneous cell landscape of patient tumors.
Retraction Note: Assessing cardiorespiratory fitness of soccer players: is test specificity the issue?–a review
Authors: Jemni Monèm , Prince Mohammad Shoaib , Baker Julien S.
Published: October 2019

The editors have retracted this article [1] because it contains substantial text and figure overlap with the following articles [2–5].
Understanding cultural diversity and economic prosperity in Europe: a literature review and proposal of a culture–economy framework
Authors: Yong Enn Lun
Published: October 2019

Increasingly, cultural diversity is being paid attention to by economists, signifying the importance of international allocation of human capital to world economic wellbeing. This paper attempts to understand how Europe can optimally benefit from cultural diversity while facing a spectrum of obstacles. Hypotheses tested by past studies are important but are generally limited by the multidimensional dynamics of the causality mechanism. This paper synthesizes the social, economic, and institutional element spiral within cultural diversity by proposing a culture–economy framework to understand economic prosperity. This paper is developed by three syntheses of the substantive literature: 1) identifying the research agenda of cultural diversity and economic prosperity, 2) conceptualizing the multidimensional dynamics from cultural diversity to economic prosperity, namely the culture–economy framework, and 3) understanding Asia–Europe relations with respect to cultural diversity and creative destruction. Intercultural learning amid complex interactions of identified elements between factor productivity and barriers was found to be the micro-foundation that links cultural diversity to economic prosperity in Europe. Cultural diversity was found to be the cause of richer ideas, heuristics, perspectives, and skills, suggesting the potential sustainability of economic prosperity with creativity-oriented policies in the region.
Safety and efficacy of a modified XELOX adjuvant regimen for patients with operated stage III colon cancer: a Chinese single‐center experience
Authors: Peng Jianhong , Li Weihao , Zhang Rongxin , Lin Junzhong , Tang Jinghua , Wen Yongshan , Lu Zhenhai , Wu Xiaojun , Pan Zhizhong
Published: October 2019

Background

A fixed 8‐cycle oxaliplatin and capecitabine (XELOX) regimen has been the standard adjuvant therapy for patients with stage III colon cancer. However, completing the full‐cycle of oxaliplatin is often associated with severe neurotoxicity. To spare patients from the toxic effects, without comprising the required efficacy, we evaluated the safety and efficacy of a modified XELOX (mXELOX) adjuvant chemotherapy regimen with 6 cycles of oxaliplatin and a full cycle of capecitabine.

Methods

We retrospectively analyzed 330 eligible patients with stage III colon cancer who underwent curative tumor resection followed by mXELOX, standard XELOX or unfinished XELOX adjuvant chemotherapy between December 2007 and April 2015. Associated prognostic factors were investigated and their disease‐free survival (DFS) and overall survival (OS) rates were also determined and compared among the different regimen groups.

Results

Compared with the standard XELOX group, the mXELOX group had lower total incidence rates of neurotoxicity (39.3% vs. 76.2%, P < 0.001), leucopenia (53.6% vs. 69.8%, P = 0.017) and thrombocytopenia (38.1% vs. 56.3%, P = 0.011). The standard XELOX and mXELOX adjuvant chemotherapy regimens presented with comparable 3‐year DFS rates (86.3% vs. 89.2%; P = 0.838) and 3‐year OS rates (92.7% vs. 97.6%; P= 0.227). Compared to unfinished XELOX chemotherapy, the oncologic benefits of the mXELOX regimen were greater for patients with T4 tumors (3‐year DFS: Hazard ratio [HR], 2.184; 95% confidence interval [CI], 1.051–4.540; P = 0.036; 3‐year OS: HR, 4.529; 95% CI 1.245–16.479; P = 0.022) and for high‐risk patients (3‐year DFS: HR, 1.962; 95% CI 0.964–3.993; P= 0.044; 3‐year OS: HR, 4.193; 95% CI 1.182–14.874; P = 0.026).

Conclusions

The mXELOX adjuvant chemotherapy presented a comparable survival benefit and lower incidence of toxicity than standard XELOX chemotherapy. It could be an alternative treatment for high‐risk patients with operated stage III colon cancer.
Genetic diversity and structure of Capsicum annuum as revealed by start codon targeted and directed amplified minisatellite DNA markers
Authors: Igwe David O. , Afiukwa Celestine A. , Acquaah George , Ude George N.
Published: October 2019

Background

Identification of high resolving DNA-based markers is of paramount importance to unlock the potential of genetic diversity and selection of unique accessions ofCapsicum annuumL., within Cross River and Ebonyi States of Nigeria, for breeding and conservation. Therefore, we comparatively explored the effectiveness of start codon targeted (SCoT) and directed amplified minisatellite DNA (DAMD) markers for diversity analysis of the accessions. Fifteen accessions were collected for DNA extraction and amplifications with the markers.

Results

Dendrograms from SCoT and DAMD categorized the accessions into five and three genetic groups, respectively, while the principal component analysis identified five genetic clusters, each from the markers. The average values of allele, gene diversity and polymorphic information content detected with SCoT and DAMD demonstrate that the two markers were effective and efficient, especially, SCoT in genetic diversity study of the accessions of pepper. Number of polymorphic loci (NPL) and percentage polymorphic loci (PPL) from SCoT (NPL = 64, PPL = 80.00–95.73%) and DAMD (NPL = 56, PPL = 53.33–86.67%) were high, but higher in SCoT markers. Other effective genetic parameters (effective number of alleles, Nei’s genetic diversity and Shannon’s information indices) identified with the two marker systems elucidated the allelic richness, rich genetic diversity within the populations and informative nature of the markers, especially SCoT. The intraspecific genetic diversity, interspecific genetic diversity, and coefficient of differentiation obtained with SCoT and DAMD further exposed the genetic structure with more genetic divergence within than among the populations of the accessions. Estimate of gene flow from the SCoT markers was 3.8375 and 0.6.2042 for the DAMD markers. The estimate of gene flow values from the markers indicated extensiveness with SCoT (Nm = 3.8375) and extremely extensive with DAMD (Nm = 6.2042) among the populations.

Conclusion

This study shows that SCoT markers may be more useful and informative than DAMD in measuring genetic diversity and differentiation of the accessions of the genusCapsicum. Genetic parameters obtained with SCoT showed that the accessions from Cross River were more genetically diverse than the ones from Ebonyi State. Therefore, SCoT may be a preferred marker in evaluating genetic diversity for improvement and conservation of this spicy crop,C. capsicum.
The gendered division of housework and fertility intention in Turkey
Authors: Kavas Serap
Published: October 2019

It is increasingly acknowledged that an equal sharing of domestic labour in a household influences women’s childbearing behavior in a positive way. Despite the growing literature on this association, there is little research exploring this phenomenon in the Middle Eastern setting. Using intensive interviews with women (n = 32), I examine how the division of domestic labour is connected to women’s intention to continue childbearing in Turkey, an understudied region. The study finds that husbands’ housework share is positively related to women’s fertility intention for an additional child in Turkey. The gender revolution framework offers an explanation for fertility and gender relationship in Turkey; however, the fact that only a small number of sampled women enjoyed domestic equality and greater desire to continue childbearing suggests that the gender revolution is just evolving in this environment.
Obstacles to advancing women’s health in Mozambique: a qualitative investigation into the perspectives of policy makers
Authors: Qiu Mary , Sawadogo-Lewis Talata , Ngale Katia , Cane Réka Maulide , Magaço Amilcar , Roberton Timothy
Published: October 2019

Background

Despite substantial investment in women’s health over the past two decades, and enthusiastic government support for MDG 5 and SDG 3, health indicators for women in Mozambique remain among the lowest in the world. Maternal mortality stayed constant from 2003 to 2011, with an MMR of 408; the estimated HIV prevalence for women of 15–24 years is over twice that for men; and only 12.1% of women are estimated to be using modern contraception. This study explores the perspectives of policy makers in the Mozambican health system and affiliates on the challenges that are preventing Mozambique from achieving greater gains in women’s health.

Methods

We conducted in-depth interviews with 39 senior- and mid-level policy makers in the Ministry of Health and affiliated institutions (32 women, 7 men). Participants were sampled using a combination of systematic random sampling and snowball sampling. Participants were asked about their experiences formulating and implementing health policies and programs, what is needed to improve women’s health in Mozambique, and the barriers and opportunities to achieving such improvement.

Results

Participants unanimously argued that women’s health is already sufficiently prioritized in national health policies and strategies in Mozambique; the problem, rather, is the implementation and execution of existing women’s health policies and programs. Participants raised challenges related to the policy making process itself, including an ever-changing, fragmented decision-making process, lack of long-term perspective, weak evaluation, and misalignment of programs across sectors. The disproportionate influence of donors was also mentioned, with lack of ownership, rapid transitions, and vertical programming limiting the scope for meaningful change. Finally, participants reported a disconnect between policy makers at the national level and realities on the ground, with poor dissemination of strategies, limited district resources, and poor consideration of local cultural contexts.

Conclusions

To achieve meaningful gains in women’s health in Mozambique, more focus must be placed on resolving the bottleneck that is the implementation of existing policies. Barriers to implementation exist across multiple health systems components, therefore, solutions to address them must also reach across these multiple components. A holistic approach to strengthening the health system across multiple sectors and at multiple levels is needed.
Inducing tunable single-mode operation of Fabry-Perot semiconductor laser coupled with very-short cavity with selective optical feedback
Authors: Al-Ghamdi Mohammed S. , Bakry Ahmed , Ahmed Moustafa
Published: October 2019

We report on achieving tuned single mode operation of a multimode semiconductor laser by coupling it to a very-short external cavity with selective feedback. We show that the induced uniform feedback light from the very-short external cavity can induce single-mode oscillation over a broad range of optical feedback. Then by applying selective external to the optimum settings of the single-mode oscillation, we predict tuning of the single-mode output over a wavelength range of ~ 20 nm by detuning the peak wavelength of optical feedback from the central wavelength of the modal gain. The study is based on modeling of the dynamics of multimode semiconductor laser subject to selective optical feedback. The model takes into account mechanisms of both self- and cross-modal gain suppression, and the study is concerned with the very-short external cavity that corresponds to stable continuous-wave (CW) operation.
Inhalation exposure to respirable particulate matter among workers in relation to their e-waste open burning activities in Buriram Province, Thailand
Authors: Bungadaeng Sarasanant , Prueksasit Tassanee , Siriwong Wattasit
Published: October 2019

The mass concentrations of fine (PM2.5) and coarse (PM2.5–10) particulate matter were determined directly from breathing zones of e-waste dismantling workers during the primitive open burning processes using a Personal Modular Impactor connected to a personal air sampler. The average concentration of PM2.5–10 was 441 ± 496 μg m− 3 (N = 33), and for PM2.5, the average concentration was 2774 ± 4713 μg m− 3 (N = 33). Additionally, the concentrations of PM10, which were the summation of PM2.5 and PM2.5–10 concentrations, had an average concentration of 3215 ± 4858 μg m− 3 (N = 33). The average PM2.5 mass concentrations accounted for 75 ± 18% from those of PM10, suggesting that PM2.5 was the main component of particulate matter that the workers were exposed to during the burning activity. The study also found that increased amounts of burnt e-waste significantly influenced the concentrations of coarse and fine particles emitted. Moreover, the Pearson’s correlation showed a positive relationship between each type of PM mass concentrations and their own total weighted scores of activity patterns. The results indicated that the activity that most increased the exposure concentration of PM2.5 was mixing e-waste on fire. In contrast, the activities that influenced the exposure of PM2.5–10 are mechanical activities, such as compiling and sweeping of e-waste, which are processes that emit and spread larger sizes of particulate matter into the air around the working environment.
New insights into the mechanisms of seismicity in the Azle area, North Texas
Authors: Chen Rongqiang , Xue Xu , Park Jaeyoung , Datta-Gupta Akhil , King Michael J.
Published: October 2019

We have performed a site-specific study of the mechanics of induced seismicity in the Azle area, North Texas, using a coupled 3D fluid flow and poroelastic simulation model, extending from the overburden into the crystalline basement. The distinguishing feature of our study is that we account for the combined impact of water disposal injection and gas and water production on the pore pressure and stress distribution in this area. The model is calibrated using observed injection wellhead pressures and the location, timing, and magnitude of seismic events. We used a stochastic multiobjective optimization approach to obtain estimated ranges of fluid flow and poroelastic parameters, calibrated to the pressure, rate, and seismic event data. Mechanisms for induced seismicity were examined using these calibrated models. The calibrated models indicate no fluid movement or pressure increase in the crystalline basement, although there is plastic strain accumulation for the weaker elements along the fault in the basement. The accumulation of strain change appears to be caused by the unbalanced loading on different sides of the fault due to the differential in fluid injection and production. Previous studies ignored the produced gas volume, which is almost an order of magnitude larger than the produced water volume under reservoir conditions and which significantly impacts the pore pressure in the sedimentary formations and the stress distribution in the basement. A quantitative analysis indicates that the poroelastic stress changes dominate in the basement with no noticeable change in pore pressure. Even though the low-permeability faults in the basement are not in pressure communication with the Ellenburger formation, the poroelastic stresses transmitted to the basement can trigger seismicity without elevated pore pressure.
Numerical and experimental simulations of multiarray azimuthal laterolog sonde responses in fractured reservoirs
Authors: Deng Shaogui , Yuan Xiyong , Wang Yang , Liang Shengyu , Zhang Jianlin
Published: October 2019

The occurrence, orientation, and development of fractures are key parameters in the evaluation of carbonate and volcanic reservoirs. We have used a 3D finite-element method to numerically simulate the logging responses of a newly proposed multiarray azimuthal laterolog sonde (MALS) in a fractured formation. More importantly, a physical simulation performed with a scaled-down 3D resistivity apparatus was developed to verify the numerical simulation results. Comparative analysis indicated that the laterolog resistivity curves are controlled by the fracture dip angles. High-angle fractures normally correspond to positive differences in the array laterolog curves, whereas fractures with low dip angles consistently result in a negative difference. The MALS tool also provides an azimuthal resistivity measurement that can be used to determine the fracture dipping direction. The sine-wave trend in the 2D imaging of azimuthal resistivity displays the fracture occurrence. In addition, MALS can be used to identify vertical fractures around a borehole within a certain distance. In addition, combined with laterolog data, the fracture occurrence and extension length can be evaluated.
Ensemble-based seismic inversion for a stratified medium
Authors: Gineste Michael , Eidsvik Jo , Zheng York
Published: October 2019

Seismic waveform inversion is a nontrivial optimization task, which is often complicated by the nonlinear relationship between the elastic attributes of interest and the large amount of data obtained in seismic experiments. Quantifying the solution uncertainty can be even more challenging, and it requires considering the problem in a probabilistic setting. Consequently, the seismic inverse problem is placed in a Bayesian framework, using a sequential filtering approach to invert for the elastic parameters. The method uses an iterative ensemble smoother to estimate the subsurface parameters, and from the ensemble, a notion of estimation uncertainty is readily available. The ensemble implicitly linearizes the relation between the parameters and the observed waveform data; hence, it requires no tangent linear model. The approach is based on sequential conditioning on partitions of the whole data record (1) to regularize the inversion path and effectively drive the estimation process in a top-down manner and (2) to circumvent a consequence of the ensemble reduced rank approximation. The method is exemplified on a synthetic case, inverting for elastic parameters in a 1D medium using a seismic shot record. Our results indicate that the iterative ensemble method is applicable to seismic waveform inversion and that the ensemble representation indeed indicates estimation uncertainty.
Multichannel absorption compensation with a data-driven structural regularization
Authors: Ma Xiong , Li Guofa , Li Hao , Yang Wuyang
Published: October 2019

Seismic absorption compensation is an important processing approach to mitigate the attenuation effects caused by the intrinsic inelasticity of subsurface media and to enhance seismic resolution. However, conventional absorption compensation approaches ignore the spatial connection along seismic traces, which makes the compensation result vulnerable to high-frequency noise amplification, thus reducing the signal-to-noise ratio (S/N) of the result. To alleviate this issue, we have developed a structurally constrained multichannel absorption compensation (SC-MAC) algorithm. In the cost function of this algorithm, we exploit an [Formula: see text] norm to constrain the reflectivity series and an [Formula: see text] norm to regularize the reflection structural characteristic of the compensation data. The reflection structural characteristic operator, extracted from the observed stacked seismic data, is the core of the structural regularization term. We then solve the cost function of SC-MAC by the alternating direction method of multipliers. Benefiting from the introduction of reflection structure constraint, SC-MAC improves the stability of the compensation result and inhibits the amplification of high-frequency noise. Synthetic and field data examples demonstrate that our proposed method is more robust to random noise and can not only improve the resolution of seismic data, but also maintain the S/N of the compensation seismic data.
Seismic geomorphology of shoal-water deltaic and mixed carbonate-siliciclastic beach-bar systems in hanging wall of rift basins: Paleogene of the Raoyang Sag, Bohai Bay Basin, China
Authors: Chen Hehe , Zhu Xiaomin , Shi Ruisheng , Zhang Zili
Published: October 2019

Recent studies of ancient rift basins focus on the tectonosedimentary models, which emphasize the control of tectonics on the distribution and evolution of depositional systems in rift basins, whereas these studies seldom address stratigraphic dominated depositional models. Compared to footwall depositional systems, hanging wall depositional systems are especially underexplored due to their fine-grained, thin-layered, and widely distributed features. We integrated seismic data, cores, and well logs to define the dispersal of hanging wall depositional systems that are related to the fluctuation of lacustrine level in the late synrift and postrift stages. We identified one third-order sequence (SQ1) on the seismic reflection data and subdivided five fourth-order sequences (SSQ1–SSQ5) based on the features of parasequence sets. The strata in SQ1 record a complete regressive and progressive lacustrine process. We interpreted shoal-water deltaic systems and mixed carbonate-siliciclastic beach-bar systems in the SQ1. Within SSQ1 and SSQ2, sediments fed from the northwest, west, and southwest, and developed shoal-water deltaic systems with an average width range of the distributary channel belts within 680–1220 m. In SSQ3, beach-bar systems gradually changed from clastic beach bars to mixed carbonate-siliciclastic beach bars in a basinward direction. Clastic beach-bar systems and mixed carbonate-siliciclastic beach-bar systems were extending north–northeast with an average length of approximately 3.5–8 km and a width of 1–4 km. For those in SSQ4 and SSQ5, shoal-water deltaic systems prograded into the lacustrine, and distributary channel belts occur with an average width range within 520–880 m. We developed a spatial and temporal quantitative evaluation of deltaic and beach-bar reservoirs within a third-order sequence on the hanging wall dip slope, and it has potential worldwide implications for other hanging wall dip slopes in rift basins.
Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer
Authors: Anderson Carryn M. , Lee Christopher M. , Saunders Deborah P. , Curtis Amarinthia , Dunlap Neal , Nangia Chaitali , Lee Arielle S. , Gordon Sharon M. , Kovoor Philip , Arevalo-Araujo Roberto , Bar-Ad Voichita , Peddada Abhinand , Colvett Kyle , Miller Douglas , Jain Anshu K. , Wheeler James , Blakaj Dukagjin , Bonomi Marcelo , Agarwala Sanjiv S. , Garg Madhur , Worden Francis , Holmlund Jon , Brill Jeffrey M. , Downs Matt , Sonis Stephen T. , Katz Sanford , Buatti John M.
Published: October 2019

PURPOSE

Oral mucositis (OM) remains a common, debilitating toxicity of radiation therapy (RT) for head and neck cancer. The goal of this phase IIb, multi-institutional, randomized, double-blind trial was to compare the efficacy and safety of GC4419, a superoxide dismutase mimetic, with placebo to reduce the duration, incidence, and severity of severe OM (SOM).

PATIENTS AND METHODS

A total of 223 patients (from 44 institutions) with locally advanced oral cavity or oropharynx cancer planned to be treated with definitive or postoperative intensity-modulated RT (IMRT; 60 to 72 Gy [≥ 50 Gy to two or more oral sites]) plus cisplatin (weekly or every 3 weeks) were randomly assigned to receive 30 mg (n = 73) or 90 mg (n = 76) of GC4419 or to receive placebo (n = 74) by 60-minute intravenous administration before each IMRT fraction. WHO grade of OM was assessed biweekly during IMRT and then weekly for up to 8 weeks after IMRT. The primary endpoint was duration of SOM tested for each active dose level versus placebo (intent-to-treat population, two-sided α of .05). The National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03, was used for adverse event grading.

RESULTS

Baseline patient and tumor characteristics as well as treatment delivery were balanced. With 90 mg GC4419 versus placebo, SOM duration was significantly reduced ( P = .024; median, 1.5 v 19 days). SOM incidence (43% v 65%; P = .009) and severity (grade 4 incidence, 16% v 30%; P = .045) also were improved. Intermediate improvements were seen with the 30-mg dose. Safety was comparable across arms, with no significant GC4419-specific toxicity nor increase of known toxicities of IMRT plus cisplatin. The 2-year follow-up for tumor outcomes is ongoing.

CONCLUSION

GC4419 at a dose of 90 mg produced a significant, clinically meaningful reduction of SOM duration, incidence, and severity with acceptable safety. A phase III trial (ROMAN; ClinicalTrials.gov identifier: NCT03689712 ) has begun.
Evaluating uptake and patient satisfaction with an out-of-pocket cost tracker for gynecologic cancer patients undergoing treatment.
Authors: Liang Margaret , Summerlin Sarah S. , Boitano Teresa KL , Blanchard Christina T. , Bhatia Smita , Huh Warner King , Pisu Maria
Published: October 2019

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Background: Tracking expenses may be useful to minimize financial distress in cancer patients. Our objective was to evaluate uptake and satisfaction with an out of pocket (OOP) cost tracker for gynecologic cancer patients on treatment. Methods: Within a longitudinal survey to assess financial burden among gynecologic cancer patients starting a new line of systemic therapy at a tertiary-care cancer center, we provided worksheets for participants to track their OOP expenses voluntarily. We assessed patient usage and satisfaction at 3 and 6 months. Financial distress was measured using Comprehensive Score for Financial Toxicity < 26. Results: Among 121 participants with an average age of 59 years, 34 (28%) were African-American and 33 (27%) had a high school diploma or less. Half (55/110, 50%) of participants reported annual income < $40,000. Most participants had health insurance (113/121, 93%) and were unemployed (77/118, 65%). Forty-nine of 121 (40%) participants reported ever using the OOP cost tracker at 3 or 6 months. Those who used the cost tracker stated it was helpful to track costs (86%, 73%), easy to use (97%, 100%), and useful for budgeting (42%, 24%) at 3 and 6 months. Participants reported using the cost tracker at least weekly (33%, 19%), every 2 weeks (36%, 27%), or monthly (31%, 54%) at 3 and 6 months. Twelve participants returned their OOP cost trackers for review with a median use of 5.5 months (range 3-10). Average monthly patient-reported OOP costs (range) were: $41 ($0-$584) for direct non-medical costs (i.e., transportation, lodging), $15 ($0-$120) for outpatient services, $13 ($0-$150) for medications/supplies, and $9 ($0-$100) for hospital services. Use of the OOP cost tracker at 3 months was not associated with financial distress at baseline (p = 0.30) or at 3 months (p = 0.89). Qualitative analysis showed the OOP cost tracker reminded patients to save receipts and to track categories of cost they would not have otherwise considered. Conclusions: 40% of gynecologic cancer patients undergoing treatment used an OOP cost tracker worksheet and found it helpful and easy to use. Direct non-medical costs accounted for the highest average monthly patient-reported OOP cost.
Utilization and costs of breast cancer screening for women in their 40s in a privately insured U.S. population.
Authors: Kunst Natalia R. , Long Jessica B. , Xu Xiao , Busch Susan , Richman Ilana , Kyanko Kelly A. , Gross Cary Philip
Published: October 2019

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Background: Despite ongoing debate about the effectiveness of initiating breast cancer screening at age 40, there is less attention paid to costs implications associated with the alternative screening starting ages. We assessed the annual costs of different screening strategies for privately insured women aged 40-49, as well as regional cost variation. Methods: We used a limited data set from Blue Cross Blue Shield (BCBS) Axis, the largest source of commercial US claims data. We identified the unit costs and frequencies of screening and subsequent evaluation for beneficiaries with continuous coverage through 2017. A Monte Carlo simulation model was developed to evaluate the annual costs of three alternate screening strategies: 1) current clinical practice, 2) annual screening beginning at age 40, or 3) annual screening beginning at age 45. The following procedures were included: screening (2-D and 3-D mammogram), supplementary ultrasound, recall (diagnostic 2-D and 3-D mammogram and ultrasound), MRI, and biopsy. We examined variability in screening-related costs across hospital referral regions (HRRs), and identified the main contributors to regional variation. Results: Overall, 69% of women in their 40s received a mammogram in 2017, resulting in an annual cost of $200 per beneficiary. This cost varied nine-fold across HRRs (range: $60-550 per beneficiary). The median cost of mammograms varied substantially across regions (2-D median cost: $206; range: $100-463; 3-D median: $271; range: $104-676). Variability in the cost of 2-D and 3-D mammogram was the main contributor to the variation in annual screening-related costs across HRRs, explaining 37% and 27% of the total variation, respectively. Screening all women beginning at age 40 would be associated with an annual cost of $309 per beneficiary (range: $127-664). Initiating screening at age 45 would cost $153 per beneficiary (range: $61-319). Conclusions: In current practice, breast cancer screening in women ages 40-49 is common, and costs $200 per eligible female beneficiary annually. Screening all women beginning at age 40 would increase the median screening-related costs by over 50%, although the cost implications vary substantially across regions.
A budget impact model for biosimilar myeloid growth factors (MGFs) within the Oncology Care Model (OCM): An oncology group practice perspective.
Authors: McBride Ali , Wang Weijia , Li Edward C. , Balu Sanjeev , Campbell Kim
Published: October 2019

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Background: Value-based programs, such as the OCM, provide incentives for healthcare providers to lower costs and improve patient outcomes. Use of biosimilar vs. reference MGFs for febrile neutropenia (FN) prophylaxis (Px) has been suggested as one strategy to help practices meet these goals. The purpose of this study is to quantify the potential impact of using biosimilar MGFs on OCM metrics from a US practice perspective. Methods: The budgetary impact of two scenarios of MGF Px for a hypothetical panel of 500 patients in 1 year receiving 6 cycles of FN-risk stratified chemotherapy (CT) was assessed; model inputs for the rates of MGF Px based on FN risk were estimated from the literature. The first scenario compares the projected 1-year total (i.e., drug and administration) costs of using LA-EP2006 (a proposed Sandoz pegfilgrastim biosimilar) vs. reference pegfilgrastim, assuming the same MGF utilization rate within the 500 patients. The second scenario evaluates the cost implications of expanding access to LA-EP2006 for 10% more patients receiving intermediate-FN risk CT and the subsequent impact on MGF costs and FN-related healthcare utilization costs (e.g., emergency visits, hospitalizations, outpatient management). MGF costs were derived from publically available data; healthcare resource utilization and costs were estimated from the literature. Results: For 500 patients receiving CT, 107 were estimated to receive MGF Px, resulting in total costs of $3.02 million (M) for reference pegfilgrastim and $2.42 M for LA-EP2006 with $1.05 M in FN-related healthcare utilization costs. If MGF access (using LA-EP2006) were expanded to 10% more patients receiving intermediate-FN risk CT, 129 patients would receive MGF Px at a cost of $2.91 M; FN-related healthcare costs would decrease by $27,155. Conclusions: Using biosimilar vs. reference pegfilgrastim can help OCM-participating practices reduce their drug costs. Potentially, a practice can address an existing gap in FN prevention by expanding biosimilar MGF access for patients receiving intermediate-FN risk CT, which may help to meet OCM metrics such as reducing hospitalizations and emergency visits.
Pathways impact on OCM drug cost.
Authors: Csik Valerie Pracilio , Minetola Jared , Walsh Karen , Ramirez Michael J. , Hurwitz Mark
Published: October 2019

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Background: Oncology care, including drugs, represents a significant portion of US healthcare spending. Cost of Part B drugs has increased at a rate 5.7x that of overall Medicare spending (1997-2004). As a participant in the Oncology Care Model (OCM), we found drug costs represent a majority of our total costs. To reduce treatment (Tx) variability, our NCI-designated cancer center chose to implement pathways. Pathways are a clinical decision-support tool that use evidence-based care maps accounting for efficacy, toxicity and cost. At one institution, use of pathways contributed to $15k in savings for stage IV lung cancer Tx. We hypothesized pathway driven Tx standardization would favorably impact total chemotherapy (CTx) costs at the implementation site. Methods: In July 2018, we implemented pathways in Medical and Radiation Oncology for new starts or changes in Tx. Oncologists accessed the tool through our EMR, selected and placed orders for Tx. OCM quarterly data was used to compare 2 quarters immediately pre- and post-pathway implementation. The cancer-mix-adjusted Per-Member-Per-Month (PMPM) Allowed Amounts for CTx were compared between 3 groups; patients on-pathway, patients off-pathway and patients for which the pathways tool was not used (no utilization). PMPMs were evaluated pre- and post-implementation and an ANOVA test was used to evaluate significance of the difference between the two periods. Results: PMPM CTx costs decreased 4.6% between pre- and post-pathway implementation when oncologists followed pathways. By comparison, the off-pathway cohort and the no utilization groups had increases of 0.9% and 17.7% respectively. An evaluation of cost difference proved significant (p < .0001). Breast patients on-pathway had a cost decrease of 20%, compared to increases of 32% and 11% for off-pathway and no utilization groups, respectively. Conclusions: Pathway use reduced variation, a known contributor to healthcare costs, and therefore may be an effective cost control tool. Additional quarters of claims data is needed post-implementation to fully define the impact of pathways on total cost.

[Table: see text]
Impact of an oncology acute care clinic (ACC) in a comprehensive cancer care setting to reduce emergency visits and subsequent hospitalizations: A pilot study.
Authors: Chaudhuri Anamika , Wagner Andrew J. , Bunnell Craig A. , Gross Anne , Green Emma , Bowers Danielle , Fraile Belen
Published: October 2019

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Background: Emergency Department (ED) visits and subsequent hospitalizations are a major source of healthcare resource utilization and costs among cancer patients, compromising quality of care and patient satisfaction. Emerging evidence, including OCM and other alternative payment models suggest many of these visits may be preventable and effectively managed in oncology-specific urgent care clinics. Little is known about such care delivery models in the comprehensive cancer care arena. Methods: As part of larger effort to provide better, efficient, timely care to patients, an acute care clinic (ACC), appropriately staffed to provide ancillary services, was set up in an academic hospital outpatient setting with hours of operations 10:30- 8:00 pm to effectively manage patients with cancer-related symptoms. The objective was to change the site of care for patients who would otherwise be seen in the ED and discharged home as well as to potentially decrease the frequency of hospitalization following ED evaluation by providing oncology subspecialized care. A retrospective analysis of 4 months pre- and post-intervention was performed with emergency visits per 1000 visits per month as the primary outcome and subsequent hospitalizations as a secondary outcome. Results: A total of 1593 patients (821 pre-intervention and 772 post-intervention) were included. Preliminary analysis revealed a 7% observed reduction in ED visits (0.25 vs 0.23 visits per month per 1000 visits; p = 0.85) for oncology patients which otherwise would have seen a 12% increase, following the historical trend. Data also suggest more effective avoidance of acute care settings with discharge disposition for patients from ED pre-intervention versus ACC post-intervention being 32% vs 72% home, 67% vs 13% inpatient, 1% vs 6% ED respectively. Conclusions: The creation of an ACC to manage urgent patient visits in an ambulatory setting decreased ED visits and the likelihood of patient admission. Although initial findings suggest improved preliminary outcomes, further analysis is required to make any causal inference on the true impact of ACC intervention for reduction of ED and hospitalizations.
The role of facility variation on racial disparities in use of hypofractionated whole breast radiotherapy.
Authors: Laucis Anna Mary Brown , Jagsi Reshma , Griffith Kent A. , Dominello Michael M. , Walker Eleanor M. , Abu-Isa Eyad I. , Dilworth Joshua T. , Vicini Frank , Kocheril Paul George , Browne Cynthia Holland , Mietzel Melissa A. , Moran Jean M , Hayman James , Pierce Lori J. ,   Michigan Radiation Oncology Quality Consortium, supported by Blue Cross Blue Shield of Michigan, and the Blue Care Network as part of the BCBSM Value Partnerships Program
Published: October 2019

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Background: Concerns about racial disparities in the adoption of medical advances motivate investigation of the use of hypofractionated radiotherapy, a less burdensome and less costly approach that is efficacious for most patients with early-stage breast cancer. Methods: A prospectively collected statewide quality consortium database from 25 institutions was queried for breast cancer patients who completed hypofractionated (HF) or conventionally fractionated whole breast radiotherapy (RT) from 1/2012-12/2018. We used patient-level multivariable modeling to evaluate associations between HF use and race, controlling for patient and facility factors, and multilevel modeling to account for patient clustering within facilities. Results: Of 10,318 patients analyzed, 80% self-reported their race as White, 18% as Black, and 2% as Asian, similar to statewide and national distributions. 31% of Whites were treated at academic centers compared to 65% of Blacks and 65% of Asians. In 2018, HF was utilized in 75% of Whites versus 60% of Blacks and 68% of Asians. On patient-level multivariable analysis (see Table), Black and Asian race were significantly associated with a lower likelihood of HF receipt, despite accounting for treatment year, age, laterality, BMI, breast volume, comorbidities, stage, triple-negative status, IMRT use, academic center treatment, and 2011 ASTRO Hypofractionation Guideline eligibility. On multilevel analysis, race was no longer significantly associated with HF receipt. Conclusions: We observed thatBlack and Asian patients receive hypofractionated RT less often, despite more frequent treatment at academic centers. Multilevel modeling eliminated this disparity, suggesting that differences in facility-specific HF use may contribute. Further inquiry is needed to determine if reduction of facility-level variation may reduce disparities in accessing HF treatment.[Table: see text]
Patient navigation (PN) for colorectal cancer screening (CRC): Experience in program implementation for underserved neighborhoods of Cleveland, Ohio.
Authors: Glass Katherine , Seals Aqeel
Published: October 2019

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Background: Cleveland, Ohio has high rates of colorectal cancer (CRC). 50% of CRC in Cleveland is late stage, and rates of CRC screening in Cleveland are low. Colonoscopy is a screening method for CRC, but barriers exist for the underserved population of Cleveland. The Fecal Immunohistochemical Test (FIT) is a less-costly and non-invasive CRC screening method that has demonstrated increased uptake in CRC screening for underserved populations. Previous literature has demonstrated that Patient Navigation (PN) can increase screening rates in underserved populations through education and assistance to overcome barriers to care. Little, however, has been published about the impact of pairing PN with a program that encourages either colonoscopies or FIT utilization to complete screening. Methods: Community members were educated about both colonoscopies and FIT in a neutral manner. After education, interested participants provided preference for screening type. Participants received follow-up calls from patient navigators. Navigators provided encouragement to complete screening and collected information about barriers. Results: N = 612 patients received PN for CRC. 72% of the population (n = 442) were Black. 47% (n = 290) chose colonoscopy, and n = 322 chose FIT. 44% (n = 263) completed a screening. 19% (n = 55) of those choosing colonoscopy completed screening. 66% (n = 213) choosing FIT completed screening. Women who chose FIT were more likely than men who chose FIT to complete screening (86% vs. 45%, p < 0.001). Barriers to screening included appointment coordination, transportation, and insurance. Conclusions: When offered PN and choice of CRC screening, community members in Cleveland equally chose colonoscopy vs. FIT. Those that chose FIT were more likely to complete screening (p < 0.001). Barriers suggest access and use of healthcare remain challenging for underserved communities. The simplicity of FIT paired with PN may remove barriers for this population and increase screening uptake. More research needs to be done to understand the impact of PN on sustained rate of completion.