bluuebunny/crossref_metadata_2025_split huggingface dataset:
The Oncology Care Model and lung cancer: Retrospective review of claims and clinical data at a large academic medical center.
Authors: Vakkalagadda Chetan , Desai Bijal , Mohindra Nisha Anjali , Kircher Sheetal Mehta 
Published: September 2021

62 Background: The Oncology Care Model (OCM) is a Center for Medicare and Medicaid Innovation (CMMI) alternative payment model designed to enhance value in cancer care. Based on a practice’s historical performance, the model predicts a target price for a 6-month episode of care and adjusts for factors such as age, modality received, geographic location, trend factor, and receipt of a novel therapy. Practices are incentivized to reduce costs of care, allowing for a performance based payment if the total cost of care is below the predicted OCM target price. At our OCM practice, when compared to other malignancy types, lung cancer has disproportionately failed to meet the OCM target. The purpose of our review was to explore the contribution of systemic therapy to total cost within the OCM model for lung cancer episodes. Methods: We reviewed claims and clinical data for the OCM Performance Period 6 (PP6), which corresponds to episodes beginning between 1/2/19-7/1/19 and ending between 7/2/19-12/31/19, for all OCM lung cancer episodes at Northwestern Medical Group. Results: 142 patients were identified with non-small cell (n = 128, 91%) and small cell lung cancer (n = 14, 9%). Patients received a PD1 inhibitor either alone or in combination with chemotherapy (n = 87), tyrosine kinase inhibitors (n = 18), both a PD1 inhibitor and a TKI (n = 2), or chemotherapy alone (n = 35). All systemic therapy use was deemed guideline compliant. 46 patients (33%) had at least 1 cancer-related hospital admission during the episode. 19 patients (13.4%) died during the OCM performance period. 39/142 (27.5%) of patients’ episode costs achieved the OCM target. Among the 103 patients whose total costs exceeded the target, drug costs alone exceeded the target in 67 (65%). Drug costs alone exceeded the total target in 59% (n = 63/107) of those who received PD1 inhibitor or TKI therapy and 11.4% (4/35) of those who received chemotherapy alone. 94% (n = 63/67) of patients for whom drug costs alone exceeded the OCM target received anti-PD1 therapy or a TKI. Conclusions: Drug cost alone exceeded the total target in the majority of OCM lung cancer episodes that did not achieve savings, highlighting the dominant role drugs play in the OCM model. With targeted therapy and immunotherapy already the standard of care in metastatic non-small cell lung cancer, and gaining a foothold in earlier stages of disease, accounting for these therapies in the OCM target price methodology will be critical for oncology practices to be successful within such value-based payment models.
Evaluation of real-world cost savings and utilization of biosimilar drugs in a community-based oncology practice.
Authors: Sanyal Amit , Schmitt Michelle , Wellner Daniel 
Published: September 2021

73 Background: Biosimilar drugs, defined as biologic products with no clinically significant differences in quality, efficacy and safety compared to approved reference products have gained increasing adoption based on studies projecting significant cost savings[1]. Real world evaluation of biosimilar related cost savings and adoption is however still limited. We prospectively evaluate cost savings generated by transitioning to biosimilar monoclonal antibodies in a community based oncology practice. Methods: In July 2020, a process for transitioning patients to biosimilar equivalents of Rituximab, Trastuzumab and Bevacizumab was implemented in a community based oncology practice. Provider adoption was facilitated by monthly oncology pharmacy governance meetings that allowed provider participation and feedback followed by defaulting the preferred biosimilar product in oncology chemotherapy software (Epic Beacon, Epic Systems, Verona, WI). The treatment templates allowed for care personalization by listing reference products that could be chosen if desired. Cost savings achieved by switching to biosimilars was calculated by subtracting the actual spending on the biosimilar product from projected acquisition cost of the branded reference product (Table). Biosimilar adoption, defined as amount of biosimilar drug used over total amount of the drug ordered was also calculated. Results: Between July 2020 and April 2021, transitioning to biosimilar products for Rituximab, Bevacizumab and Trastuzumab resulted in net savings of $268,194.64, $285,251.89 and $274,359.51 respectively. Actual spending on Rituximab biosimilar product was $726,476.10 against a projected spending of $994,670.74 on the branded reference product. Actual spending on Bevacizumab biosimilar product was $1,254,977.30 against a projected spending of $1,540,229.19 on the branded reference product. Actual spending on Trastuzumab biosimilar product was $1,218,641.60 against a projected spending of $1,493,001.11 on the branded product. Average biosimilar utilization between October 2020 and April 2020 has been 92%, 100% and 98% for Rituximab, Bevacizumab and Trastuzumab respectively. Conclusions: Significant cost-savings can result from widespread utilization of biosimilar drugs in community oncology practices. References: Mulcahy, A.W., J.P. Hlavka, and S.R. Case, Biosimilar Cost Savings in the United States: Initial Experience and Future Potential. Rand Health Q, 2018. 7(4): p. 3.[Table: see text]
Utilization of palliative care services in patients who died from stage IV non-small cell lung cancer (NSCLC): A retrospective study from a tertiary care center in rural Maine.
Authors: Rajan Sheila , Patwari Anannya , Bhatlapenumarthi Vineel , Harb Antoine Joseph 
Published: September 2021

95 Background: It is known that palliative care involvement in metastatic NSCLC cancer patients has been shown to improve quality of life in previous studies. The aim of our study was to analyze the utilization of palliative care services among patients who died from NSCLC and the setting in which these patients first received palliative care. Methods: This is a retrospective chart review analysis of patients with stage IV NSCLC who were diagnosed at Eastern Maine Medical center and the affiliated cancer center who died between January 2016 and December 2018. We collected demographic data, date and stage of diagnosis, location of palliative referral, location of first palliative care contact with the patient, time between diagnosis and death, utilization of hospice services and time between the initial palliative care consult and death. Results: 255 patients with stage IV NSCLC died between 2016 and 2018. Mean age was 65.5 years. Women were 49% and men were 51%. Majority (60%) of patients had good performance status with ECOG score between 0-1 at presentation. All 255 patients were referred to palliative care. The location of initial palliative care referral following diagnosis was 40% from the hospital, 32% from the oncology clinic and 28% from the outpatient specialist or PCP office. Overall, 174 patients (68%) were seen by palliative care and 81 (32%) were not seen. Of the patients seen 119 (68%) had their initial palliative evaluation in the hospital, and 55 (32%) in the clinic. Majority (55%) had more than one follow-up visit. Consults initiated in the inpatient setting were more likely to be seen by palliative care than in the outpatient setting (p 0.0009). Time between diagnosis to palliative care consult was less than one month in 39%, 1-2 months in 25%, 2-6 months in 21%, and more than 6 months in 14% patients. Patients seen by palliative care had a more likelihood to end up on hospice (p 0.09). The majority of patients seen by palliative care (53%) died within a month of initial consultation. Conclusions: All patients in our study population were referred to palliative care with 100% provider compliance. Among these, 68% were seen by palliative care. Interestingly, inpatient referrals were more likely to be seen by palliative care than the outpatient referrals. We think this is likely related to ease of access to palliative care team in the hospital as well as some of the patients being at terminal stages of their disease. About 33% of patients died within a month of their initial diagnosis, likely giving palliative care team a shorter window of opportunity to be seen in the outpatient setting. Prioritizing referrals of stage IV NSCLC patients might decrease the wait time after initial referral and increase the availability of palliative care services to these patients.
Association between oncology drug review times and public funding recommendations.
Authors: Gagnon Richard , Wong Chelsea , Taguedong Eddy , Maneesh Parthiv , Karim Safiya , Lee-Ying Richard M. , Ezeife Doreen Anuli 
Published: September 2021

99 Background: New oncology drugs undergo detailed review of clinical, economic, and patient data. Thoroughly assessing these data can require lengthy review processes, in the absence of accelerated approval pathways. The aim of this study was to assess how cancer drug review times impact public funding recommendations. Methods: Drugs reviewed by Canada’s health technology assessment body, the pan-Canadian Oncology Drug Review (pCODR), from April 2012 to November 2020 were included in this study. Data was collected including Health Canada approval date, initial and final funding recommendations, treatment intent, drug class, clinical indication (tumour type) and incremental cost-effectiveness ratios (ICER). Univariable and multivariable analyses were used to determine the association between funding recommendations and review times. Results: Of the 227 applications submitted to pCODR, 168 had received positive funding recommendations. Amongst the total drug applications, 24 (14.3%) drugs were intended for the treatment of thoracic cancers, 19 (11.3%) for gastrointestinal cancers, 17 (10.1%) for genitourinary cancers, 17 (10.1%) for breast cancer, and 91 (54.2%) for other tumour sites. Median time from pCODR submission to final recommendation was longer for drugs indicated for the treatment of lung and breast cancer compared to those indicated for treatment of other tumours (223 vs. 212 vs. 203 days, respectively; Kruskal-Wallis p = 0.0322). Drugs with longer review times were more likely to receive a negative pCODR recommendation, even when adjusting for ICER (157 vs 298 days, Wilcoxon p-value = 0.0003). There was no association between positive or negative funding recommendation and tumour type. Conclusions: Oncology drugs with longer review times are less likely to receive recommendation for public funding in Canada. Addressing factors contributing to variance in review times and standardizing the review process can ensure equitable access to cancer drugs.
Influence of synthetic and natural photosensitizers activated by photodynamic therapy on extrusion bond strength of fiber post to radicular dentin
Authors: Almadi Khalid H. , Alkahtany Mazen F. , Almutairi Basil 
Published: September 2021

Objective: To assess the effect of different photosensitizers activated by low-level laser therapy on EBS of glass fiber post to radicular dentin.
Methods: This study was conducted at King Saud University from January 2021 to March 202. Fifty maxillary central incisors were sanitized and decoronated. NiTi was used for mechanical instrumentation of the canal. All canals were shaped, cleaned and obturated with gutta-percha. Post space was made using peso reamers. Four Division of groups were made according to photosensitizers used (n=10). Group-1: MBP at 100mg/l, Group-2: Phycocyanin at 100mg/l, Group-3: CP at 500mg/l, and Group-4 toluidine blue photosensitizer (TB). Lasers were used for activation of photosensitizers. In Group-5 samples were irrigated using sodium hypochlorite NaOCl +17% EDTA. Posts were cemented and teeth sectioned into apical, coronal and middle. For EBS all samples were subjected to a universal testing machine. Fracture patterns were analyzed using stereomicroscope. To compare EBS at different segments One-way analysis of variance (ANOVA) and Tukey multiple comparison tests (p=0.05) was performed.
Results: The maximum value of EBS was shown in Group-2 radicular canal treated with CP with 17% EDTA at all three levels cervical (8.61±1.32 MPa), middle (6.81±0.73 MPa), and apical (5.51±0.25 MPa). Similarly, the minimum value of EBS was displayed in Group-5 canal irrigated with 2.25% NaOCl +17% EDTA (control) coronal (6.10±1.77 MPa), middle (5.11±0.75 MPa), and apical (3.60±0.94 MPa). Intragroup assessment disclosed a decrease in EBS from cervical one-third to apical one-third in all groups
Conclusion: P, CP, and TB along with EDTA have the potential to be used as canal disinfectant and favors the bonding of GFP to radicular dentin using self-etch adhesive resin.
doi: https://doi.org/10.12669/pjms.37.7.4331
How to cite this:Almadi KH, Alkahtany MF, Almutairi B. Influence of synthetic and natural photosensitizers activated by photodynamic therapy on extrusion bond strength of fiber post to radicular dentin. Pak J Med Sci. 2021;37(7):---------. doi: https://doi.org/10.12669/pjms.37.7.4331
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Der Bericht des Minoïdes Mynas über die Bibliothek des Klosters des hl. Ioannes Prodromos tu Bazelonos
Authors: Stefec Rudolf S. 
Published: September 2021

Abstract
The short catalogue of the manuscripts of the monastery of St. John the Forerunner tu Bazelonos written by Minoïdes Mynas (Par. suppl. gr. 1248, ff. 187v- 190v) in February 1845 is edited and the entries (19) matched with the only other known catalogue penned by A. Papadopulos-Kerameus in 1909 (40 entries), based on a visit to the monastery in 1884. Two of the manuscripts contained in the catalogue of Mynas can be identified (Par. suppl. gr. 613; Petropolit. BPG 743); the rest is probably lost. An inscription contained in manuscript nr. 39 of the monastery and transcribed by Papadopulos-Kerameus identifies Manuel I. Komnenos as the founder of the convent.
No footprint too small: case of intrauterine herpes simplex virus infection
Authors: Lopushinsky Kaitlyn M. , Harabor Andrei , Bodani Jaya 
Published: September 2021

Abstract

Objectives
To describe the case of a preterm infant with intrauterine HSV infection. To discuss the epidemiology, features and complications associated with intrauterine HSV infection by conducting a review of medical literature.

Case presentation
A preterm male infant was born with diffuse skin erosions in various stages of healing suggestive of denuded bullae. Prenatal ultrasound showed evolving fetal cerebral ventriculomegaly, suspected Dandy-Walker malformation, and oligohydramnios. Neonatal skin swabs were positive for herpes simplex virus type 2 by polymerase chain reaction and the patient was treated with intravenous acyclovir from birth. Cranial ultrasound and magnetic resonance imaging findings showed severe progressive ex-vacuo ventricular dilatation consistent with intrauterine herpes simplex infection. Due to those findings and progressive multi-organ dysfunction, care was redirected to a palliative path and the child expired at 21 days of age. In retrospect, the mother had a few atypical vesicles on the left hand 4–5 weeks prior to delivery with a presumptive diagnosis of pompholyx.

Conclusions
Although confirmed intrauterine herpes simplex virus (HSV) infections are very rare, the potentially devastating prognosis and complications as evidenced by our case show that awareness of intrauterine HSV is critical for pediatricians as well as physicians involved in antenatal care. In order to adequately assess, treat and counsel pregnant women, more work is required to detect HSV infection, evaluate possible congenital infection and improve outcomes with fetal and neonatal treatment.
Wirecard and European Company and Financial Law
Authors: Mock Sebastian 
Published: September 2021

Abstract

Wirecard constitutes not only a major scandal in Germany but also touches some fundamental concepts of European corporate and capital market law and will therefore dominate the discussion for further reforms for several years. This discussion will touch general questions of corporate governance, the examination of financial reports, the role of auditors, the (current) market abuse regime and yet again short sellings. Some reforms are in a way self-evident and will probably be undertaken within this or next year. This is especially the case for a (further) reform of the regulation of auditors and for a reform of the regulation of the examination of financial reports. For both areas – usually stricter – concepts already exist and will this time have a better chance to be enacted. Therefore, Wirecard might turn to be a bad case that hopefully does not make bad law. However, there also are other aspects such as the relation of the market abuse regime and financial reporting that might require a deeper and longer analysis before concrete legislative measures can be put into place. The same applies for a further reform of the corporate governance of listed corporations, the regulation of short sellings and especially for the creation of a European framework for invalid (or false) financial reports. For these aspects Wirecard might constitute some kind of promoter for a further harmonization. This paper gives a short summary of the already publicly known facts of the Wirecard scandal, analyses how European Company and Financial Law was involved and identifies the challenges for a reform of European Company and Financial Law.
Clawback Provisions in Executive Compensation Contracts
Authors: Stark Johanna 
Published: September 2021

Abstract
Clawbacks are contractual provisions in executive compensation contracts that allow for an ex post recoupment of variable pay if certain triggering conditions are met. As a result of regulatory responses to financial crises and corporate scandals, as well as growing shareholder pressure to implement effective measures against executive misbehaviour, the prevalence of such clauses has risen considerably in the recent past, beginning in the US after the 2000 financial crisis. As clawbacks have become a buzzword in the European debate about also ensuring good corporate governance beyond the financial sector, it is time to critically discuss the hopes that have been associated with various types of such provisions.
The number of response categories in ordered response models
Authors: Iannario Maria , Monti Anna Clara , Scalera Pietro 
Published: September 2021

Abstract
The choice of the number m of response categories is a crucial issue in categorization of a continuous response. The paper exploits the Proportional Odds Models’ property which allows to generate ordinal responses with a different number of categories from the same underlying variable. It investigates the asymptotic efficiency of the estimators of the regression coefficients and the accuracy of the derived inferential procedures when m varies. The analysis is based on models with closed-form information matrices so that the asymptotic efficiency can be analytically evaluated without need of simulations. The paper proves that a finer categorization augments the information content of the data and consequently shows that the asymptotic efficiency and the power of the tests on the regression coefficients increase with m. The impact of the loss of information produced by merging categories on the efficiency of the estimators is also considered, highlighting its risks especially when performed in its extreme form of dichotomization. Furthermore, the appropriate value of m for various sample sizes is explored, pointing out that a large number of categories can offset the limited amount of information of a small sample by a better quality of the data. Finally, two case studies on the quality of life of chemotherapy patients and on the perception of pain, based on discretized continuous scales, illustrate the main findings of the paper.
Following a New York Case: The Impact of Vaccination Exemptions for School Aged Children on Biosecurity
Authors: Goegel Kathleen 
Published: September 2021

Abstract
The anti-vaccination trend is growing in the United States and with this trend comes risk. Although there are a limited number of people who cannot receive vaccinations for medical reasons, many people who choose not to vaccinate their children use a vaccination exemption to ensure their child(ren) are able to attend school. I will be focusing on the risk associated with school-aged children who are not vaccinated. This risk is primarily focused on public health and biosecurity, which deals specifically with the national health issues and possible bioterrorism threats originating in schools. This risk is only enhanced by the fact that exemptions differ from state to state, and states have broad exemptions. In my analysis of the anti-vaccination trend with school-age children and the risk associated with it, I will be looking at the case of M.A. et al v. Rockland County Health Department out of the Southern District Court of New York and connecting the facts of that case to the countrywide risk.
M.A. et al. v. Rockland Cty. Dep’t of Health, No. 7:19-cv-02066 (S.D.N.Y Mar. 06, 2019).
My analysis will begin by looking at the specifics of that case and the constitutional implications that came along with it. I will then use that case and the outbreak in Rockland County to present the possible biosecurity and public health implications that come with children not being vaccinated. Finally, I will present my recommendation on vaccination exemptions as it pertains to limiting these implications in the future.
The congruence subgroup problem for finitely generated nilpotent groups
Authors: Ben-Ezra David El-Chai , Lubotzky Alexander 
Published: September 2021

Abstract
The congruence subgroup problem for a finitely generated group Γ and for

G
≤

Aut
⁢

(
Γ
)

G\leq\mathrm{Aut}(\Gamma)

asks whether the map

G
^

→

Aut
⁢

(

Γ
^

)

\hat{G}\to\mathrm{Aut}(\hat{\Gamma})

is injective, or more generally, what its kernel

C
⁢

(
G
,
Γ
)

C(G,\Gamma)

is.
Here

X
^

\hat{X}

denotes the profinite completion of 𝑋.
In the case

G
=

Aut
⁢

(
Γ
)

G=\mathrm{Aut}(\Gamma)

, we write

C
⁢

(
Γ
)

=

C
⁢

(

Aut
⁢

(
Γ
)

,
Γ
)

C(\Gamma)=C(\mathrm{Aut}(\Gamma),\Gamma)

.
Let Γ be a finitely generated group,

Γ
¯

=

Γ
/

[
Γ
,
Γ
]

\bar{\Gamma}=\Gamma/[\Gamma,\Gamma]

, and

Γ
*

=

Γ
¯

/
tor

⁢

(

Γ
¯

)

≅

Z

(
d
)

\Gamma^{*}=\bar{\Gamma}/\mathrm{tor}(\bar{\Gamma})\cong\mathbb{Z}^{(d)}

.
Define

Aut
*

⁢

(
Γ
)

=

Im
⁡

(

Aut
⁢

(
Γ
)

→

Aut
⁢

(

Γ
*

)

)

≤

GL
d

⁢

(
Z
)

.

\mathrm{Aut}^{*}(\Gamma)=\operatorname{Im}(\mathrm{Aut}(\Gamma)\to\mathrm{Aut}(\Gamma^{*}))\leq\mathrm{GL}_{d}(\mathbb{Z}).

In this paper we show that, when Γ is nilpotent, there is a canonical isomorphism

C
⁢

(
Γ
)

≃

C
⁢

(

Aut
*

⁢

(
Γ
)

,

Γ
*

)

.

C(\Gamma)\simeq C(\mathrm{Aut}^{*}(\Gamma),\Gamma^{*}).

In other words,

C
⁢

(
Γ
)

C(\Gamma)

is completely determined by the solution to the classical congruence subgroup problem for the arithmetic group

Aut
*

⁢

(
Γ
)

\mathrm{Aut}^{*}(\Gamma)

.
In particular, in the case where

Γ
=

Ψ

n
,
c

\Gamma=\Psi_{n,c}

is a finitely generated free nilpotent group of class 𝑐 on 𝑛 elements, we get that

C
⁢

(

Ψ

n
,
c

)

=

C
⁢

(

Z

(
n
)

)

=

{
e
}

C(\Psi_{n,c})=C(\mathbb{Z}^{(n)})=\{e\}

whenever

n
≥
3

n\geq 3

, and

C
⁢

(

Ψ

2
,
c

)

=

C
⁢

(

Z

(
2
)

)

=

F
^

ω

C(\Psi_{2,c})=C(\mathbb{Z}^{(2)})=\hat{F}_{\omega}

is the free profinite group on countable number of generators.