bluuebunny/crossref_metadata_2025 huggingface dataset:
Association between frequency of dairy product consumption and hypertension: a cross-sectional study in Zhejiang Province, China
Authors: Wang Hao , Chen Lingli , Cao Yuan , Xie Kaixu , Wang Chunmei , Pei Pei , Guo Yu , Bragg Fiona , Yu Min , Chen Zhengming , Li Liming
Published: September 2022

Background

Hypertension, a well-known risk factor, contributes to millions of deaths from cardiovascular and renal diseases worldwide. However, evidence on the association between frequency of dairy product consumption and hypertension is inconsistent.

Methods

The data for the present study are from the Tongxiang baseline dataset of the China Kadoorie Biobank prospective study. A total of 53,916 participants aged 30–79 years were included in the final analysis. Multivariable logistic regression was utilized to evaluate the association of dairy product consumption with hypertension, and multiple linear regression was conducted to assess the association of dairy product consumption with systolic and diastolic blood pressure.

Results

Of the 53,916 participants, 2.6% reported consuming dairy products weekly, and 44.4% had prevalent hypertension. After adjusting for socio-demographic status, lifestyle factors, BMI, waist circumference, sleep duration and snoring, when compared with participants who never consumed dairy products, the odds ratios (95% CI) for hypertension among those consuming dairy products less than once per week, and ≥ 1 time per week were 0.85 (0.77–0.95) and 0.74 (0.65–0.84), respectively. The corresponding odds ratios (95% CI) for men were 0.85 (0.71–1.02) and 0.75 (0.61–0.92), respectively (Ptrend = 0.001), and for women were 0.88 (0.76–1.01) and 0.77 (0.65–0.91), respectively. (Ptrend < 0.001).

Conclusions

In this large epidemiological study, higher frequency of dairy product consumption is associated with significantly lower odds of hypertension among Chinese adults.
Circulating and urinary microRNAs profile for predicting renal recovery from severe acute kidney injury
Authors: Phulkerd Thanawat , Lertussavavivat Tanat , Limothai Umaporn , Peerapornratana Sadudee , Kulvichit Win , Lumlertgul Nuttha , Tungsanga Kriang , Eiam-Ong Somchai , Avihingsanon Yingyos , Srisawat Nattachai
Published: September 2022

Background

There is little known about the contribution of microRNAs (miRNAs) in the recovery from acute kidney injury (AKI). This study aimed to discover and validate miRNA profiles for predicting renal recovery from severe AKI.

Patients and methods

A prospective observational study was conducted between June 2020 and January 2021. Urine and serum samples of participants with AKI stage 3 were collected from two groups: renal recovery and renal non-recovery. Transcriptomic analysis was performed using nCounter miRNA Expression Assay. Expression levels of candidate miRNAs were validated using quantitative real-time polymerase chain reaction (qRT-PCR).

Results

The discovery phase identified 18 and 11 differentially expressed miRNAs that were statistically significant between the two groups in urine and serum specimens, respectively. Top candidate miRNAs selected included miR-556-3p, miR-1915-3p, miR-4284, miR-32-5p, miR-96-5p, and miR-556-5p in urine, and miR-499b-5p, miR-30a-3p, miR-92b-3p and miR-770-5p in serum. This study enrolled 110 participants in the validation phase. The qRT-PCR analysis indicated that urine miR-556-3p was significantly higher in the renal recovery group than in the renal non-recovery group. Urine miR-556-3p alone predicted renal recovery with an area under the curve (AUC) of 0.64 (95%CI 0.52–0.75, p = 0.03). Combining the clinical model with urine miR-556-3p predicted renal recovery with an AUC of 0.83 (95%CI 0.75–0.92, p < 0.01).

Conclusion

This data provides evidence that microtranscriptome profiles of severe AKI patients with renal recovery differed from the non-recovery group. Urine miR-556-3p had the potential to improve the prediction of renal recovery from severe AKI.
Highly tailorable gellan gum nanoparticles as a platform for the development of T cell activator systems
Authors: Rodrigues Daniel B. , Moreira Helena R. , Cerqueira Mariana T. , Marques Alexandra P. , Castro António G. , Reis Rui L. , Pirraco Rogério P.
Published: September 2022

Background

T cell priming has been shown to be a powerful immunotherapeutic approach for cancer treatment in terms of efficacy and relatively weak side effects. Systems that optimize the stimulation of T cells to improve therapeutic efficacy are therefore in constant demand. A way to achieve this is through artificial antigen presenting cells that are complexes between vehicles and key molecules that target relevant T cell subpopulations, eliciting antigen-specific T cell priming. In such T cell activator systems, the vehicles chosen to deliver and present the key molecules to the targeted cell populations are of extreme importance. In this work, a new platform for the creation of T cell activator systems based on highly tailorable nanoparticles made from the natural polymer gellan gum (GG) was developed and validated.

Methods

GG nanoparticles were produced by a water in oil emulsion procedure, and characterized by dynamic light scattering, high resolution scanning electronic microscopy and water uptake. Their biocompatibility with cultured cells was assessed by a metabolic activity assay. Surface functionalization was performed with anti-CD3/CD28 antibodies via EDC/NHS or NeutrAvidin/Biotin linkage. Functionalized particles were tested for their capacity to stimulate CD4
+
T cells and trigger T cell cytotoxic responses.

Results

Nanoparticles were approximately 150 nm in size, with a stable structure and no detectable cytotoxicity. Water uptake originated a weight gain of up to 3200%. The functional antibodies did efficiently bind to the nanoparticles, as confirmed by SDS-PAGE, which then targeted the desired CD4
+
populations, as confirmed by confocal microscopy. The developed system presented a more sustained T cell activation over time when compared to commercial alternatives. Concurrently, the expression of higher levels of key cytotoxic pathway molecules granzyme B/perforin was induced, suggesting a greater cytotoxic potential for future application in adoptive cancer therapy.

Conclusions

Our results show that GG nanoparticles were successfully used as a highly tailorable T cell activator system platform capable of T cell expansion and re-education.
An integer-order SIS epidemic model having variable population and fear effect: comparing the stability with fractional order
Authors: Mukherjee Manisha , Mondal Biswajit
Published: September 2022

This paper investigates the dynamics of an integer-order and fractional-order SIS epidemic model with birth in both susceptible and infected populations, constant recruitment, and the effect of fear levels due to infectious diseases. The existence, uniqueness, non-negativity, and boundedness of the solutions for both proposed models have been discussed. We have established the existence of various equilibrium points and derived sufficient conditions that ensure the local stability under two cases in both integer- and fractional-order models. Global stability has been vindicated using Dulac–Bendixson criterion in the integer-order model. The forward transcritical bifurcation near the disease-free equilibrium has been investigated. The effect of fear level on infected density has also been observed. We have done numerical simulation by MATLAB to verify the theoretical results, found the impact of fear level on the dynamic behaviour of the infected population, and obtained a bifurcation diagram concerning the constant recruitment and fear level. Finally, we have compared the stability of the population in integer and fractional-order systems.
Formulation development, optimization and characterization of mucoadhesive minitablets of cefuroxime axetil: in vitro, ex vivo and in vivo pharmacokinetic evaluation
Authors: Panda Jayanti , Rao Muddana Eswara Bhanoji , Swain Suryakanta , Patra Chinam Niranjan , Jena Bikash Ranjan
Published: September 2022

Background

The current study expands on the use of design of experiment in developing cefuroxime axetil mucoadhesive minitablets for treating antibiotic-associated colitis. A comprehensive QbD-based product development strategy was implemented, with the target product profile defined based on the desired product quality of mucoadhesive minitablets. The identified critical quality attributes are based on the target product profile. The goal was to find the optimum levels by using the concentrations of chitosan (mg) (X1), HPMC K100M (X2) and sodium carboxymethyl cellulose (X3) as the influential variables. The response surface methodology determines the dependent variables using 33Box–Behnken design to optimize the selected critical factors. The friability (%), drug content (%) and mucoadhesive strength (%) characteristics of cefuroxime axetil mucoadhesive minitablets were evaluated using ANOVA for the observed responses or dependent variables.

Results

The study demonstrated that run 8 with optimum composition chitosan, HPMC K100M and sodium carboxy methyl cellulose, which are the mucoadhesive polymers, showed a desirable and promising drug release profile up to 24 h, higher percentage of drug content, mucoadhesion and swelling index.

Conclusions

The optimized mucoadhesive minitablets of cefuroxime axetil demonstrated desired formulation characteristics, including improved bioavailability and high control over the drug’s release rate and increased flexibility in adjusting both the dose and the drug’s release rate. In a nutshell, the studies support the successful development of mucoadhesive minitablets of cefuroxime axetil, which could be used to treat antibiotic-associated colitis.
A multidisciplinary approach to operationalizing financial toxicity interventions: The MSK Affordability Working Group.
Authors: Aviki Emeline Mariam , Chino Fumiko , Gany Francesca , Caramore Amy , Doyle Stephanie , Liebhaber Allison , Newman Tiffanny , Sokolowski Stefania , Thom Bridgette
Published: September 2022

2

Background: The financial toxicity (FT) of cancer is a concern for the healthcare system. Rising costs and increased cost-sharing result in high levels of financial burden, with negative implications for treatment adherence, quality of life, and financial well-being. As FT interventions must consider the interdependent systems of barriers patients face, this project highlights efforts toward developing and testing hospital-based FT interventions through the creation of the Memorial Sloan Kettering (MSK) Affordability Working Group. Methods: An interdisciplinary task force aimed to 1) characterize FT among patients receiving treatment at MSK; 2) identify areas for systemic change. Members included physicians, nurses, and social workers, and representatives from patient billing/financial services, health services research, and hospital administration and strategy. The team first conducted a review of medical records (2016 – 2018) to determine FT incidence and current practices for financial assistance uptake. Absent a formal FT screening, proxy measures defined FT as having bill payment issues, applying for financial assistance, or expressing financial concerns to Social Work, and we analyzed the percent of each category referred for assistance. Post-analysis program processes are also described. Results: Of 89,283 records reviewed, 22,187 (25%) patients experienced FT. Of 14,178 patients with payment issues, only 22% had been referred for financial assistance. As such, streamlining the assistance referral process became a priority, leading to the creation of an FT order set for providers to make direct referrals. From 3/2021-2/2022, 843 orders were placed, with $836,000 in co-pay assistance and $13,500 in essential needs assistance linked to the order set. The task force then met with hospital leadership to formally expand into an institutional working group, with organizational buy-in demonstrated through increased staffing and monetary support of patient-level pilot interventions. Stakeholders were engaged through presentations at departmental grand rounds and to individual disease teams. Operational and research efforts are now focused on systematic FT screening of patients, including validating a screening tool, developing nurse-led staff and patient education, assessing stakeholder feedback, and determining an appropriate screening cadence and workflow by disease type. Conclusions: With at least 25% of patients at MSK experiencing financial difficulties related to cancer treatment, it was, and remains, vital to develop systems-based interventions to proactively assess FT risk and refer to tangible resources. Planned future work includes implementation of universal FT screening with reflex referral to financial assistance, testing patient-level educational interventions, and developing policy/advocacy recommendations.
Therapeutic interchange: The cornerstone of cost effectiveness in the Oncology Care Model performance for the U.S. Oncology Network.
Authors: Ives Hope , Feinberg Erica , Indurlal Puneeth , Wilfong Lalan S. , Dominguez Kaci , Garey Jody S.
Published: September 2022

5

Background: The Oncology Care Model (OCM) is a Medicare value-based care program, that rewards practices for decreasing the total cost of care (TCOC) compared to a benchmark price. Enrolled patients are evaluated in 6-month episodes within a 1-year time window called Performance Periods (PP). The use of lower cost medication alternatives (LCA) is a critical strategy to bend the cost curve. Therapeutic interchange (TIC) with lower-cost generic/biosimilar/therapeutic alternative medications offer significant cost savings to payers and patients while maintaining equivalent quality of care. LCA for eight high-cost oncology therapeutic or supportive care medications became available during or just prior to OCM. The results of a clinically appropriate, physician-supported, pharmacist-led interchange of high-cost medications to LCA in The US Oncology Network (The Network) during OCM PP 7 (PP7), 8 (PP8), and 9 (PP9) is described here. Methods: Medicare Part B & D claims for 14 OCM practices in The Network were used to evaluate the impact of eight TIC opportunities during PP 7-9. TIC opportunities included changing therapy from reference products to biosimilars (bevacizumab, trastuzumab, rituximab, pegfilgrastim and filgrastim), from brand to generics (abiraterone, imatinib, fosaprepitant) and from high cost to LCA (aprepitant to fosaprepitant, denosumab to zoledronic acid). TCOC impact was measured by comparing the cost of each dose of the LCA vs the estimated cost if the more expensive alternative had been used instead. Results: The shift from high cost to LCAs in PP7, PP8 and PP9 is shown in Table as percentage of total doses dispensed or administered. Transitions from aprepitant to fosaprepitant, and from denosumab to zoledronic acid was done when clinically appropriate (as determined by the treating physician). The cumulative savings from TIC was $26.0M in PP7, $32.3M in PP8 and $32.9M in PP9. TIC to biosimilars contributed $6.6M in PP8 and $12.2M in PP9 of the cumulative savings. TIC reduced TCOC by 2.78% in PP7, 4.13% in PP8, 5.25% in PP9 within the OCM. Conclusions: TIC to biosimilars, generics and clinically appropriate LCA is an effective way to reduce TCOC while maintaining quality care in the OCM. Even small shifts in utilization towards LCA can generate a significant reduction in TCOC. Physician-supported, pharmacist-led TIC initiatives are critical to bending the cost curve within Oncology.[Table: see text]
Staff experiences with remote work in a comprehensive cancer center during the COVID-19 pandemic.
Authors: McChesney Christopher , Powis Melanie Lynn , Espin-Garcia Osvaldo , Morley Lyndon , Hack Saidah , Krzyzanowska Monika K.
Published: September 2022

41

Background: The COVID-19 pandemic led to the rapid implementation of remote work, but few studies have evaluated the impact on staff and care delivery in healthcare settings. Utilizing a cross-sectional survey, we evaluated the experience of working remotely among clinical staff at the Princess Margaret Cancer Centre, Toronto, Canada. Methods: “Remote work” was defined as any work (tasks, projects, healthcare delivery) performed from home. A Qualtrics survey was disseminated via email three times from June-August 2021 to 1,168 physicians, nurses, allied health, and administrative staff involved in patient care. The survey evaluated staff perceptions of productivity, efficiency, patient safety, quality, and personal experiences. Results were summarized using descriptive statistics. Associations between respondent demographics and responses on perceived efficiency, desire to work remotely, support and safety/quality were evaluated using multivariable binary logistic regression models. Free-text responses were categorized into facilitators and barriers, and summarized using qualitative descriptive analysis. Results: Most respondents (n = 333; response rate: 28.5%) were female (61.3%) and physicians (23.1%). Few respondents (1.5%) worked remotely more than half the time pre-COVID which increased to 66.6% during COVID-19. Majority reported that remote work positively impacted productivity (61.8%) and efficiency (57.6%) and expressed interest in continuing (79.0%) beyond the pandemic. While most respondents agreed with the switch to remote work (89.2%), few were provided with the necessary equipment (14.1%). Some respondents perceived a negative impact on the safety (13.8%) or quality of care (18.6%) delivered remotely. Across clinical roles, compared to administrative staff, physicians were more likely to report remote work having a negative impact on productivity (OR = 24.04, 95% CI: 2.71-213.00), being dissatisfied with remote work (OR: 8.41, 95% CI: 1.37-51.64), being dissatisfied with training available (OR: 2.70, 95% CI: 0.95-7.67), and disagreed with continuing to utilize remote work beyond the pandemic (OR: 16.61, 95% CI: 1.45-190.14). Improved efficiency, less commuting, and improved work-life balance were perceived as facilitators of remote work. Barriers included a lack of clear role expectations, issues accessing clinical applications and out-of-pocket expenses. Conclusions: Our findings indicate that remote work may be a viable model in hospitals beyond the pandemic. Given the variation in experience and perceptions depending on clinical role, addressing barriers and formal evaluation of the impact of working remotely on productivity, efficiency and quality of care should be considered to inform long-term adoption.
COVID-19 clearance among patients with cancer during the Delta and Omicron waves.
Authors: Avigan Zachary M , Paredes Rodrigo , Boussi Leora S , Lam Barbara , Shea Meghan , Weinstock Matthew , Peters Mary Linton Bounetheau
Published: September 2022

42

Background: COVID-19 presents a particular challenge in oncology, as in-person visits and treatments can be delayed during infection and patients are at risk for prolonged viral shedding. Our center uses two consecutive negative PCR tests for patients to return to clinic. As vaccination rates increase, we questioned the need for this strategy vs a time-based clearance approach. Methods: We identified cancer patients who tested positive for COVID-19 from 10/1/2021 to 3/31/2022 at a single tertiary care center and performed chart review under an IRB-approved protocol. Subgroups were compared using the Welch’s t-test and Welch’s ANOVA for 2 or > 2 groups, respectively. Results: 169 patients were identified. 153 had documented clearance defined as two consecutive negative PCR tests. The mean clearance time was 35.7 days (95% CI 32.3-39.0). There was a trend toward longer clearance time in patients with hematologic vs solid tumors (39.6 vs 33.2, p =.06) and a significant increase in patients treated with B cell depletion (58.0) vs chemo/targeted therapy (35.7, p =.01) or immunotherapy (29.0, p =.004). No significant difference was found by vaccination status or between the Delta and Omicron waves. If defined as one negative test, mean clearance time was 25.9 days (95% CI 23.6-28.1), and there was a significant difference in patients with hematologic vs solid tumors and in those treated with B cell depletion vs other therapies. However, 16.0% (27/169) of patients had a subsequent positive test after a first negative result, with increased incidence in patients with hematologic malignancy (26.2%, 16/61) and stem cell/adoptive cell transplant (46.2%, 6/13). Conclusions: COVID-19 is a significant barrier to oncologic care, and clearance times remain longer than reported for the general population. In this single center study, clearance time was > 1 month and further increased in patients with hematologic malignancy or on B cell depleting therapy. While adjusting clearance criteria to a single negative test or specific timeframe may be an attractive option to reduce delays, a large proportion of patients may have further positive PCR testing.[Table: see text]
Oncologist perspectives on tumor boards: Virtual meetings and EHR integration.
Authors: Arafat Waddah , Fu Paul , Wagner Andrew J. , Osterman Travis , Martin Daniel , Sugalski Jessica , Heinrichs Tricia , Racz Jennifer M. , Tevaarwerk Amye Juliet
Published: September 2022

46

Background: Tumor boards (TBs) are considered a key component for ensuring high quality cancer care. However, little is known about TB operational aspects that impact effectiveness. We aimed to understand how TBs leverage Electronic Health Record (EHR) functionalities and how pandemic-driven transitions from in-person TBs to virtual TBs impacted TB quality and effectiveness. Methods: The National Comprehensive Cancer Network (NCCN) Oncology EHR Advisory Group formed a Workgroup to assess the current state of TBs, obtain providers’ views on ideal TB state, and develop recommendations for improving TB quality and effectiveness. The Workgroup surveyed providers in various specialties at 31 NCCN Member Institutions in March 2022. Results: 846 providers from 27 institutions responded to the survey (n = 76 respondents were excluded from analysis because they reported not participating in TBs). Almost all (n = 764/767, 99%) indicated that one or more participants always or frequently attended TB meetings virtually. When comparing (newly established) virtual to (pre-pandemic) in-person TBs, 69% indicated increased attendance at virtual TBs. 65% reported no change in case volume, and 56% reported unchanged discussion quality while 19% reported increased discussion quality when comparing virtual to in-person TB meetings. In regards to EHR integration, several gaps between current and ideal state were noted. For instance, 40% always or frequently added patients to the TB roster via the EHR, but 57% reported this functionality to be very important or important for TBs. Additionally, 53% always or frequently document TB recommendations within the EHR, while 87% indicated EHR documentation of recommendations as very important or important. Respondents reported that barriers to documentation include resource constraints, concerns with patient access to documentation, legal and liability concerns, and poor EHR functionality. Conclusions: Overall, the majority of responding providers reported virtual TBs to be at least similar in quality to in-person TB meetings. A major gap identified by this study is the lack of documentation of TB recommendations in the EHR. Workflows and EHR functionalities could be improved to fully optimize the EHR for TB management and documentation.[Table: see text]
Price variability of pembrolizumab across U.S. National Cancer Institute–designated Cancer Centers (NCICCs) from 2016-2021.
Authors: Hussaini S. M. Qasim , Johnson Jordan , Chino Fumiko
Published: September 2022

48

Background: NCICCs are poorly compliant to price transparency rules set forth by the CMS. Competitive price shopping is prevented due to a lack of uniform rate setting, and service charges are often higher than what a hospital reasonably expects to be reimbursed. We investigated variability in the charged and reimbursed payments for pembrolizumab utilizing Medicare claims across all NCICCs. Methods: Medicare claims data from 2016-2021 for pembrolizumab (HCPCS J9271) infusions in a hospital outpatient department were selected from the Definitive Healthcare claims database for all hematology-oncology and medical oncology providers at NCICCs. Average charges, reimbursements, and total claims were obtained. Annual percentage changes (APC) were calculated to evaluate trends during study period. Prices are presented as inflation adjusted numbers (charged and reimbursed; 2021 dollars). Analyses were performed in Excel (Microsoft Corp). Results: Our analysis included 53 NCICCs of which 47 were part of the 340B Drug Pricing Program (NCI-340B), 11 were Prospective Payment System-exempt (NCI-PPS), and 6 NCICCs were both (PPS/340B). From 2016 to 2021, total Medicare claims increased from 9461 to 46291 across NCICCs, with NCI-PPS centers comprising 30% of claims. Total payments to NCICCs increased from $55.9M to $388.1M annually. Average charge for pembrolizumab in 2021 were: $45,227 (NCI-PPS), $46,000 (all NCICCs), $49,057 (NCI-340B), $59,392 (dual-eligible PPS/340B). During study period, APC were: 9.2% (NCICCs), 9.6% (NCI-340B), 12.8% (NCI-PPS), and 17.5% (dual-eligible PPS/340B). Despite high charged prices, reimbursement was much lower, about 18.4% (or $7364) of charged price at NCICCs over study period. Highest reimbursement was noted at NCI-PPS (22%, or $8551), and lowest at NCI-340B (16.4% or $7086) over study period. When considering a smaller cohort of PPS-only or 340B-only, PPS-only status was associated with lowest charged price but highest reimbursement (33.5%, or $8568). Conclusions: NCICCs charged > 4 times the average reimbursed price for pembrolizumab, with charges increasing faster than inflation. While lower charges were noted at NCI-PPS, they received higher reimbursement. Dual PPS/340B status commanded the highest charged prices and quickest price increases. Our study informs greater price transparency regulation at NCICCs and raises questions regarding utility of special status benefits from the federal government.[Table: see text]
Guidelines and workflow for virtual simulation.
Authors: Parikh Dhwani , Kollmeier Marisa
Published: September 2022

49

Background: An important component of radiation treatment planning is the CT simulation which involves several steps including patient positioning, imaging in the treatment position, and placement of an isocenter, a point through which the central rays of the radiation beams pass. As radiation therapy is an important component of palliative treatment for metastatic cancer, some patients require multiple courses which may be temporally proximate. This creates a burden for patients who may be challenged with regard to mobility, distance, and logistics coordinating travel to the department. We sought a clinical workflow that maintains the integrity of the simulation process but allows the potential use of previously obtained treatment planning imaging to create a new treatment plan (i.e. virtual CT simulation). We present our workflow and experience here. Methods: A multidisciplinary group developed a virtual simulation workflow and identified critical criteria to safely and reliably proceed with virtual simulation. These included: time from initial CT simulation (< 14 days), adequacy of patient positioning and immobilization, as well as appropriate inclusion of the entire “virtual” planning treatment volume (PTV) and organs at risk (OARs) in the original scan. Specific virtual simulation care paths were created in treatment planning software (Aria®, Varian Medical Systems) for case tracking. A pilot was initiated to monitor the workflow for the first 10 patients and corrections to the workflow were made. Thereafter the program was randomly audited and the QA reporting system monitored for reported error events. Results: The virtual simulation workflow pilot was initiated in June 2020. Of the first 50 virtual simulation requests, 48 were approved (96%). Two cases were denied due to inadequate immobilization. There was only one event reported pertaining to set up uncertainty requiring clarification from physics. Conclusions: Given the success of the virtual simulation criteria and workflow we will continue this practice and will monitor the cases as well as RISQ events closely. Based on feedback we have received we will expand the window of time to request a virtual simulation from 14 days to 21 days after original simulation and will also allow for up to 3 virtual isocenters to be placed.
Socioeconomic disparities in the receipt of palliative care in biliary tract cancers.
Authors: Abodunrin Faith , Adeoye Oluwatayo , Krishnan Mridula , Silberstein Peter T. , Tupper Connor
Published: September 2022

80

Background: Biliary tract cancers are tumors arising from epithelial cells lining the biliary tract including the intrahepatic bile duct, extrahepatic bile duct, gall bladder, and ampulla of Vater. The incidence of biliary tract cancers has over the years. While there have been several advances in the diagnosis and treatment of biliary tract cancers, palliative treatment remains important in the management of these cancers. This study aims to analyze the patterns associated with the receipt of palliative care in patients with biliary tract cancers. Methods: We conducted a retrospective review of 150,007 patients in the National Cancer Database diagnosed with biliary tract cancer between 2004-2018 using ICD-O3 codes. Chi-square tests were used to assess the differences between palliative care recipients and non-recipients. Logistic regression was used to assess which variables influence the likelihood of receiving palliative care. Statistical analyses were performed using SPSS. Results: The overall palliative care utilization amongst patients with biliary tract cancers was 13%. The use of palliative care in biliary tract cancers gradually increased over the years. Patients with gall bladder cancers were less likely to receive palliative care than those with intra-hepatic biliary duct cancers (OR 0.60 p < 0.001). Our study also found significant differences in the utilization of palliative care based on race. Blacks were less likely to use palliative care than whites (OR 0.89 p = 0.001). Hispanic patients were less likely to utilize palliative care than whites (OR 0.70 95% CI 0.64-0.76). There was no statistically significant difference between the use of PC between Whites and Asians (OR 1.04 95% CI 0.95-1.13 p < 0.441). Privately insured patients were less likely to receive palliative care than uninsured patients (OR 0.88 p = 0.029). There were no statistically significant differences between the receipt of palliative care in uninsured patients and Medicare or Medicaid patients (OR 0.98 p = 0.69; OR 1.00 p = 0.93). Patients belonging to households with a median income (> $63,333) were less likely to receive palliative care than those in low-income (< $40,000) household (OR 0.67 p < 0.001). There was an increased likelihood of receiving palliative care in patients from communities with higher educational status. Patients who received treatment at academic/research programs were more likely to receive palliative care than those at community cancer programs (OR 1.18 95% CI 1.08-1.29). Conclusions: Our study identified disparities in the receipt of palliative care in biliary tract cancers based on socioeconomic status. Blacks and Hispanics were less likely to receive palliative care than whites. Interestingly, uninsured patients were more likely to receive palliative care than privately insured patients. As part of quality improvement, future research should address the drivers behind these reported disparities.
Differences in the utilization of palliative care support services among patients with metastatic solid tumor cancer in a community oncology setting: A retrospective review.
Authors: Weidenbaum Chloe , Bilbrey Larry Edward , Dickson Natalie R. , Schleicher Stephen Matthew , Owens Leah , Blakely L. Johnetta , Frailley Susan A , Scalise Melissa , Cantrell Lee S. , Mudumbi Sandhya
Published: September 2022

82

Background: Palliative care has been underutilized in the setting of advanced cancer despite its established benefit in improving the quality of life in cancer patients. Few studies have evaluated socioeconomic disparities in receiving palliative care in the outpatient oncology setting. We aimed to evaluate for disparities in utilization of palliative care among patients with metastatic solid tumor malignancies at Tennessee Oncology, a large outpatient community oncology practice with an established palliative care program. Methods: We completed a retrospective review of medical records of 1513 patients that were seen in Tennessee Oncology clinics from 12/2020 to 12/2021. We compared the baseline characteristics of patients with metastatic solid tumor malignancies who did and did not receive palliative care. Chi-square and two-sample t-tests were used for data analysis with the 5% significance level using R statistical software. Results: Male patients utilized palliative care less often than female patients (17% versus 24% for females, p =.0002; 95% CI,.05-1.0). Of payer types, Medicare had the least palliative care utilization (14%) compared to commercial (25%) and other payers (23%). Utilization also varied by cancer type, with melanoma (9%), lung cancer (15%) and renal cancer (21%) being least likely to receive palliative care (p <.00005; 95% CI,.19-1.0). We did examine racial differences in palliative care utilization, but those did not reach statistical significance. Conclusions: There are multiple disparities in the utilization of on-site palliative care support services among patients with metastatic solid tumor cancer in this outpatient community oncology setting. Further research is needed to gain insight into why this is, including an in-depth analysis of both patient and provider utilization/referral practices.[Table: see text]
Why aren’t more patients with breast cancer enrolled in clinical trials?
Authors: Lalor Fallon , Caston Nicole E. , Ingram Stacey A. , Wan Clara , Sussell Jesse , Patel Shilpen A.
Published: September 2022

84

Background: Only 2-8% of adult patients with cancer participate in clinical trials, likely due to strict exclusion criteria as well as financial and access issues. The primary objective of this study is to understand the population of patients with breast cancer who are and are not offered a clinical trial and the impact of exclusion criteria on enrollment. Methods: Inclusion and exclusion criteria from study protocols housed in OnCore and ClinicalTrials.gov were obtained for breast cancer-specific, therapeutic clinical trials open at the University of Alabama at Birmingham (UAB) from 2016 to 2020. Patients with breast cancer receiving oncology services at UAB from 2016 to 2020 were identified from electronic health records. Race and ethnicity and address were abstracted. Address was utilized to characterize patients as living in areas of higher vs. lower deprivation (Area Deprivation Index) and rural communities (Rural-Urban Commuting Area). Chart abstraction was conducted to assess if patients were offered a trial, eligible for a trial, reason for ineligibility, and enrollment in trial vs standard of care treatment. Results: 518 patients were included; 387 were offered a trial and 131 were not. The median age of patients offered a trial was 57 years old, whereas the median age of patients who were not offered a trial was 61. The majority of patients offered a trial were more often White (72% vs. 24% African American), resided in areas of lower disadvantage (70% vs 17% most disadvantaged), and urban residents (75% vs 13% rural). Of the 387 patients offered a trial, 319 (82%) enrolled, 34 (9%) declined enrollment and chose standard of care, and the remaining 34 (9%) were interested in enrollment but later found to be ineligible. Reasons for ineligibility of the 34 patients who were offered a trial included comorbidities (n = 9), tumor size (n = 7), metastases (n = 5), and previous cancer history (n = 4). Additionally, 9 patients were ineligible for miscellaneous reasons (abnormal labs, age, prescription, trial closed to accrual, tumor characteristics). Of the 131 patients that were not offered a clinical trial, 77 (59%) were ineligible for enrollment. Reasons for ineligibility included: stage 1 disease (n = 35), tumor size and characteristics (n = 24), and comorbidities and abnormal labs (n = 18). The remaining 54 patients would have been eligible, but their provider did not offer a clinical trial. Conclusions: Most patients who are offered a clinical trial are willing to participate; physicians not offering a trial to patients appears to be a driver for low enrollment. Strict exclusion criteria related to comorbidities limit trial participation. Further work is needed to understand the relative importance of these eligibility criteria in relation to validity. Efforts should be made to include patients in clinical trials that reflect the diverse patient population that will receive the drug in the future.
Mammographic follow-up before and during the COVID-19 pandemic.
Authors: Manik Ritika , Grady Connor B. , Ginzberg Sara , Edmonds Christine E. , Elmore Leisha C , Lewandowski Julia T , Hubbard Rebecca A. , Fayanju Oluwadamilola Motunrayo
Published: September 2022

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Background: Mammography adapted during the COVID-19 pandemic to accommodate social-distancing guidelines and minimize risk of exposure, but it is unclear how these accommodations potentially provoked existing inefficiencies or illuminated opportunities to redress them. The goal of this study was to compare rates of (1) diagnostic follow-up after a BIRADS 0 (i.e., incomplete) screening mammogram and (2) biopsy following a BIRADS 4 or 5 (i.e., biopsy recommended) diagnostic mammogram before and after onset of the pandemic. Methods: We included women ≥18y who underwent a BIRADS 0 screening mammogram and/or BIRADS 4-5 diagnostic mammogram at our institution from 3/15/19-3/15/21. Given seasonal variation in care receipt, pre-COVID (3/15/2019-3/15/20) and COVID (3/15/20-3/15/21) time periods were compared at a quarterly level. Case-mix adjusted associations between time-to-follow-up and COVID vs pre-COVID quarters (Q1-4) were estimated using multivariate Cox proportional hazards models. Results: We identified 17,918 women (Asian: 985, Black: 4054, Hispanic: 840, White: 11,302) who received a total of 14,388 BIRADS 0 screening and 6410 BIRADS 4 or 5 diagnostic mammograms. There were far fewer diagnostic mammograms in COVID Q1 vs pre-COVID Q1 (Table), and they were more likely to be followed up with biopsy (HR 1.21 [95% CI 1.03-1.44], p = 0.023). COVID Q3 (HR 0.92 [95% CI 0.86-0.98], p = 0.002) and Q4 (HR 0.88 [95% CI 0.83-0.95], p < 0.001) screens were less likely to be followed up with diagnostic mammograms but volumes were higher vs the respective pre-COVID quarters (Table). However, COVID Q3 patients with BIRADS 4 or 5 mammograms were 18% more likely to undergo biopsy than their pre-COVID Q3 counterparts (HR 1.18 [95% CI 1.07-1.31], p < 0.0001, Table) despite higher COVID volumes. Conclusions: Early in the pandemic, patients were more likely to receive mammographic follow-up, potentially due to lower patient volumes and enforced strategies for more efficient, less time-intensive care delivery. These gains were lost with regards to diagnostic follow-up for screening mammograms but maintained with regards to performing biopsies. As volumes return to or surpass pre-pandemic levels, health systems must work to identify and preserve operational efficiencies gained during the early pandemic.[Table: see text]
Time to diagnosis and treatment initiation during the COVID-19 pandemic among rural patients with cancer.
Authors: Okado Izumi , Liu-Duerr Michelle , Elhajj Carry , Holcombe Randall F.
Published: September 2022

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Background: Time to diagnosis (TTD) and treatment initiation (TTI) are important measures of access and quality of cancer care, but little is known about TTD and TTI for rural cancer patients. Rural residents experience disproportionate burdens of cancer including higher incidence and mortality, and many rural patients face challenges in health care access. Further understanding of TTD and TTI in rural areas is essential to improving the quality of cancer care delivery and cancer outcomes in rural areas. In this study, we describe TTD and TTI among rural cancer patients in Hawaii during the COVID-19 pandemic. Methods: Information about TTD and TTI was collected from 80 rural cancer patients enrolled on a care coordination study between Sept. 2020 and Dec. 2021. Participants were receiving active treatment for any cancer and residing in rural areas in Hawaii. We used descriptive statistics to describe TTD and TTI for the overall sample and specifically for those with breast and GI cancers, the two most common cancers in this study sample. Results: Participants were 56% female, with the mean age of 63 (SD = 12.1). 43% were White/Caucasian, 30% Native Hawaiian, and 25% two or more race. Reporting of symptoms to a healthcare provider led to diagnosis for 61.6% of the overall sample, whereas 38.4% received diagnosis following screening. For breast cancer, 36.8% indicated symptoms led to diagnosis, and 63.2% by screening. Among those with GI cancer, 76.5% reported symptoms led to diagnosis, and 23.5% by screening. Overall, 62.5% of participants reported TTD of within one month (< = 30 days) of screening or reporting symptoms to a healthcare provider (30-day TTD 62.5% for breast and 60.0% for GI). Median TTI for the overall sample was 60.6 days (IQR 30-62). For those with breast and GI cancers, median TTI was 61.0 (IQR 31-70) and 31.0 (IQR 0-61) days, respectively. Conclusions: Our results demonstrate that although TTD in this rural sample was comparable to other studies, TTI overall, and particularly for those with breast cancer, was nearly twice the TTI reported in other population-based studies. Delays in cancer treatment initiation have been associated with worse survival for breast and other cancers, especially among underserved populations. Our findings indicate that during the COVID-19 pandemic, rural residents in Hawaii experienced substantial delays in cancer treatment initiation. This study highlights the importance of addressing timely healthcare system access to minimize delays in treatment initiation and to improve health outcomes for rural cancer patients.
Tele-chemotherapy and related outcomes to improve rural cancer care.
Authors: Thota Ramya , Mullalley Megan , Gill David Michael , Rowett Kimberlee , Reese Zachary , Haslem Derrick S.
Published: September 2022

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Background: We previously reported the safety and feasibility of tele-chemotherapy with remote administration of chemotherapy (chemo) in rural hospitals using experienced chemo nurses with direct supervision from medical oncologist at a tertiary site. Herein we report the detailed overview of types of cancers treated, chemo-regimens administered and associated outcomes within an integrated health system. Methods: We retrospectively analyzed 200 patients who received chemotherapy remotely in 4 rural health hospitals in the state of Utah between 2017- 2022. Data collected included age of administration of chemo, gender, cancer type, insurance, chemotherapy regimen, number of cycles, emergency visits, hospitalizations, and infusion reactions. Results: 200 pts received chemotherapy at 4 rural hospitals including Sevier Valley Hospital, Cassia Regional Hospital, Sanpete Valley Hospital, and Heber Valley Hospital in Utah and Idaho. Median age of administration was 53 yrs (11- 96 yrs). Majority were male (n = 118; 59%). Insurances that covered these services included Medicare, Medicaid, Regence Blue Cross, United Healthcare, Tricare and Select Health. The most common cancer types treated included – Colorectal (n = 31), Breast (n = 24), Lung (n = 15), Lymphoma (n = 21), Multiple Myeloma (n = 11), Melanoma (n = 9), Bladder (n = 7), and other benign conditions (n = 25). 47 unique chemo regimens including 1085 cycles were administered. Chemo regimens and cycles detailed below. Among 69 pts with outcomes data available, ED visits noted in 33% (n = 23), hospitalization rate was 17% (n = 12) and infusion reaction rate was 7% (n = 5). Total mileage saved by pts receiving chemotherapy closer to home was 47,955 miles. Conclusions: Tele-chemotherapy is safe, feasible and provides improved access to cancer care in rural areas. Future design of pragmatic clinical trials where remote administration of standard of care treatments closer to home will allow the rural pts access cutting edge clinical trials closer to home.[Table: see text]
Disparities in overall survival (OS) outcomes based on treating facility volume in pancreatic neuroendocrine tumors.
Authors: Tella Sri Harsha , Kommalapati Anuhya , Desai Aakash , McGarrah Patrick Walsh , Hobday Timothy J. , Halfdanarson Thorvardur Ragnar
Published: September 2022

150

Background: Pancreatic neuroendocrine tumors (pNETs) comprise less than 5% of all pancreatic tumors and 7% of all neuroendocrine tumors (NETs). There has been considerable progress in understanding the biology of pNETs and numerous therapeutic options emerged, especially with the collaboration of various specialties in the multidisciplinary setting. In this this study, we sought to analyze the association of facility volume, treatment modalities offered, and different risk adjusted outcomes in pNETs. Methods: We extracted data from National Cancer Data Base (NCDB) that covers 70% of all newly diagnosed cancer cases in the U.S and Puerto Rico. Patients with pNETs diagnosed between 2004 & 2017 were included and classified into tertiles based on hospital volume. Volume–outcome relationship was determined by using Cox regression adjusting for patient demographics, comorbidities, tumor characteristics, insurance type and therapy received. Kaplan Meier estimates of OS were compared with log-rank test. The primary predictor of interest was the facility volume defined as number of pNETs treated/year. A total of 7202 patients with pathologically confirmed pNETS were treated at 840 facilities. The median annual facility volume was 5patients/year. Facilities were classified into (T:mean cases/year) T1: < 3; T2:4-8; T3:≥9 cases/year. Results: A total of 7202 pNET patients were treated at 840 facilities. The median annual facility volume was 5 patients/year. Facilities were classified into (T: mean cases/year) T1:<3; T2:4-8; T3:≥9 cases/year. The unadjusted median OS by facility volume was: T1: 71 months (m), T2: 136 m, and T3: not-reached (p < 0.001). On multivariable analysis, compared with patients treated at T3 facilities, patients treated at lower-tertile facilities had higher risk of death [T2 hazard ratio (HR), 1.17 (95% CI, 1.03-1.33); T1 HR, 1.45 (CI, 1.30-1.67), p < 0.0001] and such a difference in OS was more pronounced in stage IV disease (Table). Patients at T3 facilities (vs T1) were more likely to receive surgical resection of the primary tumor (75 vs 49%), lymph node dissection performed at the time of surgery (70 vs 42%), and a better R0 resection (72 vs 46%) (p < 0.01). Conclusions: Patients who were treated for pNETs at high-volume centers (> 9cases/year) had significantly higher OS and were more likely to receive surgical resection along with lymph node dissection and R0 resection. There was a 45% increased risk of death in patients treated at low volume centers (< 3/year) as compared to high-volume centers (> 9/year). While OS difference was noticed in all stages, the difference was more pronounced in stage IV disease demonstrating the importance of multi-disciplinary approach in pNETs management and incorporating such quality measures in low-volume facilities.[Table: see text]