bluuebunny/crossref_metadata_2025_split huggingface dataset:
Oncology patients’ perspectives on remote patient monitoring for COVID-19.
Authors: Daly Robert Michael , Lauria Tara , Holland Jessie C. , Garcia Jericho , Majeed Jibran , Walters Chasity , Strachna Olga , Chow Kimberly , Giles Caitlin E. , Kelly Meghan F , Reidy Diane Lauren 
Published: June 2021

1504 Background: Oncology patients are particularly vulnerable to adverse outcomes from COVID-19 and require careful monitoring to identify early deterioration and render higher level care when indicated. Several institutions launched remote patient monitoring programs (RPMPs) to care for patients with COVID-19. We describe patients’ perspectives on a COVID-19 RPMP at a National Comprehensive Cancer Center. Methods: Adult patients who had either tested positive for COVID-19 on an outpatient microbiology test or were discharged after hospitalization for the virus were eligible. Patients enrolled in the RPMP received a daily 10-question electronic patient-reported outcome assessment of COVID-19 symptoms and their responses generated alerts to a centralized monitoring team for new or worsening symptoms. A subset of high-risk patients also received a pulse oximeter which alerted when blood oxygen levels dropped below 93%. RPM was discontinued 14 days after a patient’s positive test result and following 3 days without worsening symptoms or fever. Patients who exited the program and had completed at least one assessment were sent a patient engagement survey. The objective of the survey was to evaluate the patient’s experience with digital monitoring and symptom management for COVID-19. The assessment was structured with objective response questions, including a net promoter score, and free text questions to elicit patient perspectives on RPM value. Free text responses were analyzed using grounded theory to identify primary themes regarding perceived value. Results: The survey was distributed to 452 patients; 241 responded as of June 10, 2020 (53% completion rate). The net promoter score was 91%. The table provides responses to objective questions. Qualitative analysis of free text responses identified the primary themes regarding patient perceived value which included: 1) Security: patients appreciated that the RPMP provided a clinical safety net; 2) Connection: patients appreciated the link to their clinical team during a period of isolation; 3) Empowerment: patients appreciated that the RPMP provided education on the virus and symptom management. Conclusions: RPMPs are perceived to be of value to oncology patients with COVID-19. A key barrier to maintaining these programs is cost. Policymakers should consider how these programs can be reimbursed in the future so that they can continue to provide care to vulnerable patients and keep them at home out of the acute care setting.[Table: see text]
Identification of patients at high risk for preventable emergency department visits and inpatient admissions after starting chemotherapy: Machine learning applied to comprehensive electronic health record data.
Authors: Peterson Dylan J. , Ostberg Nicolai P. , Blayney Douglas W. , Brooks James D. , Hernandez-Boussard Tina 
Published: June 2021

1511 Background: Acute care use is one of the largest drivers of cancer care costs. OP-35: Admissions and Emergency Department Visits for Patients Receiving Outpatient Chemotherapy is a CMS quality measure that will affect reimbursement based on unplanned inpatient admissions (IP) and emergency department (ED) visits. Targeted measures can reduce preventable acute care use but identifying which patients might benefit remains challenging. Prior predictive models have made use of a limited subset of the data available in the Electronic Health Record (EHR). We hypothesized dense, structured EHR data could be used to train machine learning algorithms to predict risk of preventable ED and IP visits. Methods: Patients treated at Stanford Health Care and affiliated community care sites between 2013 and 2015 who met inclusion criteria for OP-35 were selected from our EHR. Preventable ED or IP visits were identified using OP-35 criteria. Demographic, diagnosis, procedure, medication, laboratory, vital sign, and healthcare utilization data generated prior to chemotherapy treatment were obtained. A random split of 80% of the cohort was used to train a logistic regression with least absolute shrinkage and selection operator regularization (LASSO) model to predict risk for acute care events within the first 180 days of chemotherapy. The remaining 20% were used to measure model performance by the Area Under the Receiver Operator Curve (AUROC). Results: 8,439 patients were included, of whom 35% had one or more preventable event within 180 days of starting chemotherapy. Our LASSO model classified patients at risk for preventable ED or IP visits with an AUROC of 0.783 (95% CI: 0.761-0.806). Model performance was better for identifying risk for IP visits than ED visits. LASSO selected 125 of 760 possible features to use when classifying patients. These included prior acute care visits, cancer stage, race, laboratory values, and a diagnosis of depression. Key features for the model are shown in the table. Conclusions: Machine learning models trained on a large number of routinely collected clinical variables can identify patients at risk for acute care events with promising accuracy. These models have the potential to improve cancer care outcomes, patient experience, and costs by allowing for targeted preventative interventions. Future work will include prospective and external validation in other healthcare systems.[Table: see text]
Risk for SARS-CoV-2 infection in patients with breast cancer treated with chemotherapy, biologic therapy or active surveillance: Patient outcomes from multicenter institution in New York.
Authors: Budhathoki Nibash , Kucharczyk John , D'Abreo Nina , Kwa Maryann J. , Plasilova Magdalena , Dhage Shubhada , Hindenburg Alexander A. , Lee Joanna , Winner Megan , Daly Alison , Soe Phyu Phyu , Ramdhanny Angela , Schnabel Freya Ruth , Oratz Ruth , Speyer James L. , Novik Yelena , Meyers Marleen Iva , Jones Simon , Adams Sylvia , Marks Douglas Kanter 
Published: June 2021

1513 Background: In high-risk estrogen-receptor positive, HER2 positive, or triple negative breast cancer (BC), chemotherapy can increase cure rates in early-stage disease and prolong survival in setting of advanced disease. Real world data specific to BC is needed to counsel patients (pts) with BC on their risk for SARS-CoV-2 infection and mortality in the context of the SARS-CoV-2 pandemic. Methods: In this retrospective study, we abstracted clinical data including demographics, tumor histology, cancer treatment, and COVID-19 testing results status from the electronic medical record of 3778 BC patients who received cancer care from 02/01/2020 – 05/01/2020 in New York City at our cancer center. The primary endpoint of the study was incidence of SARS-CoV-2 infection by treatment type (cytotoxic chemotherapy (CT) vs non-cytotoxic therapies (endocrine and/or HER2 directed therapy (E/H)) diagnosed by either serology, RT-PCR, or documented clinical diagnosis. Probability of Treatment Weighting (IPTW) and Mann-Whitney Test were used to assess risk of SARS-CoV-2 infection by treatment and assess outcomes based on oncologic and non-oncologic risk factors respectively. Results: 3062 patients met inclusion criteria with 379 pts in CT, 2343 pts in E/H and 340 in NT groups. During study period 641 patients (20.9%) were tested by either PCR or serology with 64 patients (2.1%) diagnosed with COVID-19. All pts who tested positive by PCR and subsequently had serology testing were positive for IgG. The weighted risk of SARS-COV-2 infection was 3.5% in CT vs. 2.7% in E/H (p=0.523). 27 patients (0.9%) expired over follow up, with 10 deaths attributed to SARS-CoV-2 infection. The weighted risk for death was 0.7% with CT vs. 0.1% with E/H, p=0.24 (Table A). Age, BMI,CCI and advanced cancer stage were associated with increased mortality following SARS-CoV-2 infection (Table). Conclusions: CT was not associated with increased risk of infection with SARS-CoV-2 infection or death following infection. BC cancer treatment, including CT, can be safely administered with enhanced infectious precautions and should not be withheld particularly when given for curative intent.[Table: see text]
Growth in eligibility criteria content and failure to accrue among National Cancer Institute (NCI)-affiliated clinical trials.
Authors: Peterson John Stuart , Plana Deborah , Bitterman Danielle Sara , Johnson Skyler B , Kann Benjamin Harris 
Published: June 2021

1515 Background: Cancer clinical trial accrual across diverse socioeconomic and demographic groups is a national priority, yet up to 20% of trials fail due to poor accrual. Eligibility criteria content may contribute to poor accrual, but effects are challenging to measure. We sought to evaluate growth of eligibility criteria within NCI-affiliated cancer trials and the impact on trial accrual over the past decade. Methods: We conducted a retrospective study with the Aggregate Analysis of ClinicalTrials.gov (AACT) (abstracted: 02/02/2021). We included NCI-affiliated, interventional Phase II or III trials that initiated between 01/01/2008 and 12/13/2018. We excluded active and recruiting trials that lacked accrual data on the Cancer Trials Support Unit website. Trials whose status was “Withdrawn”, “Terminated”, or “Suspended” due to low accrual, or had less than 50% target accrual after two years active were deemed accrual failures. Eligibility criteria were extracted from inclusion and exclusion criteria and complexity was estimated by the number of unique content words, calculated by removing duplicates and stop words from the word count. Association of unique word count with accrual failure was evaluated by univariable and multivariable logistic regressions, adjusting for other predictors of low accrual identified in earlier research. Results: Of 1197 trials included, 231 (19.3%) failed due to low accrual. Eligibility criteria increased in length from a median of 214 (IQR [23, 282]) unique content words in 2008 to 417 (IQR [289, 514]) in 2018. The rate of trial accrual failure increased with unique word count decile from 11.8% in the first decile (12 to 112 words) to 29.4% in the tenth decile (445 to 750 words) (P = 0.004). On multivariable analysis, unique word count remained independently associated with low accrual (OR: 1.07 per decile, 95%CI [1.01-1.13], P = 0.02), as did Phase III and metastatic disease settings (Table). Conclusions: Eligibility criteria content has increased dramatically in the last decade in NCI-affiliated trials. Increasing eligibility criteria content associates strongly with accrual failure, even after adjusting for multiple known predictors of accrual. These findings underscore the need for efforts to simplify eligibility criteria to improve trial accrual. Further investigation is ongoing to determine specific criteria qualities that portend accrual failure.[Table: see text]
The validity of progression-free survival (PFS) 2 as a surrogate endpoint for overall survival (OS) in randomized controlled trials (RCTs) of advanced solid tumors.
Authors: Woodford Rachel , Zhou Deborah , Kok Peey-Sei , Lord Sally , Marschner Ian , Friedlander Michael , Lee Chee Khoon 
Published: June 2021

1516 Background: OS is the gold-standard endpoint for treatment efficacy in oncology RCTs. However, prolonged follow-up is required to obtain mature data, which impedes regulatory approval of potentially beneficial therapies. Furthermore, increasing therapeutic options including cross over to investigational agents at disease progression often confound OS findings. PFS-2, defined as time from randomization to progression on second-line therapy, has been proposed as a potential surrogate endpoint for OS. Using a meta-analytic approach, we aimed to assess the association between OS and PFS-2, and its validity compared with other surrogate endpoints. Methods: We performed an electronic literature search to identify RCTs of systemic therapies that reported PFS-2 as a pre-specified endpoint with defined follow up protocols. Articles were screened for eligibility and outcome data were extracted. Correlations in the relative treatment difference between treatment arms for OS vs PFS-2, PFS-1, and objective response rate (ORR) were assessed as the comparison of hazard ratios (HR) and odds ratio (OR) respectively. Results: 38 eligible RCTs comprising of 44 analysis units, with 19,031 patients across 8 unique tumor types were identified. The majority received targeted therapies (72.2%), followed by immunotherapy (IO; 26.3%). The correlations of HR-OS/HR-PFS-2, HR-OS/HR-PFS-1 and HR-OS/OR-ORR were r = 0.67 (95% CI 0.08-0.69), r = 0.12 (95% CI 0.00-0.13) and r = 0.21 (95% CI 0.00-0.33) respectively. Correlations between OS with surrogates was assessed in different subgroups according to post-progression survival times (SPP), types of treatment agents and rate of subsequent therapy after progression (table). Conclusions: Across diverse tumors and therapies, treatment effect on PFS-2 has modest to strong correlation with OS, but poor correlations were observed between OS-PFS-1 and OS-ORR respectively. Across all subgroups, PFS-2 performs consistently better than traditional surrogates of PFS-1 and ORR, validating and providing support for use in future RCTs.[Table: see text]
Patient factors associated with time to medication receipt of oral anti-cancer drugs.
Authors: Lichtenstein Morgan RL , Beauchemin Melissa , Doshi Sahil , Raghunathan Rohit , Law Cynthia , Accordino Melissa Kate , Elkin Elena B. , Wright Jason Dennis , Hershman Dawn L. 
Published: June 2021

1519 Background: The past decade has seen a dramatic increase in the number of Food and Drug Administration approvals of oral anti-cancer drugs (OACDs). Most OACD prescriptions require coordination between providers, payers, specialty pharmacists, and financial assistance organizations, which can delay drug receipt. We evaluated median time to OACD receipt (TTR) from initial OACD prescription submission and assessed clinical and process-related factors associated with TTR. Methods: We prospectively collected data on all new OACD prescriptions for adult oncology patients at a large, urban outpatient cancer center from 1/1/2018 to 12/31/2019. We collected patient demographic, medical, and insurance data; prescription submission and delivery dates; and interactions with payers and financial assistance groups. TTR was defined as the number of days from OACD initial prescription to patient receipt of the drug. We estimated the median TTR across all patients and used multivariable logistic regression to identify factors associated with TTR above the median. Results: The cohort included 1080 patients who were prescribed 1269 new OACDs. Of these prescriptions, 84% (N=1069) were received, and 71% (N=896) required prior authorization. The median patient age was 66, 44% identified as Non-Hispanic White (White), 25% of patients had commercial insurance, 16% had Medicaid alone, and 58% had Medicare alone or in combination with another plan. The median TTR per patient was 7 days (IQR 0 – 142; 25% ≥ 14 days and 5% ≥ 30 days). In unadjusted analyses, insurance and race/ethnicity were associated with TTR. Compared with patients covered by Medicaid, those with Medicare and supplemental insurance (a partial, not free-standing plan) had nearly 2.5 times the odds of TTR >7 days controlling for other factors. Race/ethnicity showed a trend toward longer TTR with Non-Hispanic Black (Black) patients having a longer TTR compared to White patients, controlling for other factors. We did not observe statistically significant effects of either comorbidity or prior authorization requirement on TTR. Conclusions: Though the majority of oncology patients prescribed OACDs receive the drug, 71% of prescriptions required prior authorization and a quarter of patients waited at least two weeks. Disparities in TTR are primarily driven by financial factors, specifically insurance type.[Table: see text]
Patient navigation plus hospital at home to improve COVID-19 outcomes for cancer patients.
Authors: Ragon Brittany K. , Sumrall Ashley Love , Blackley Kris , Osunkwo Ify , Moyo Tamara Kay , Kabrich Laura , Leonard Kelly , Masten Ben , York Beth , Murphy Stephanie , Kersten Brian , Batchelor Thomas , Rivet Carly , Parala-Metz Armida , Shahid Zainab , Chai Seungjean , Musselwhite Laura W. , Walsh Declan 
Published: June 2021

1524 Background: Reports suggested cancer patients were at greater risk for increased morbidity and mortality from COVID-19. A process to mitigate these risks was established at Levine Cancer Institute (LCI) in partnership with Atrium Health’s (AH) Hospital at Home (HAH) initiative. This virtual health navigation process employed expertise from the departments of Hematologic Oncology and Blood Disorders, Oncology, and Supportive Oncology, including a specialized nurse navigation team, to rapidly identify COVID-19 positive LCI patients, monitor them under physician supervision, and escalate care as needed with AH HAH program. Methods: AH Information Services created an automated list of LCI COVID-19 positive patients with a daily database. Each patient was reviewed by a nurse navigator. Review included hematologic or oncologic diagnosis, outpatient or inpatient status, and any COVID-19 symptoms. Once a malignant diagnosis was confirmed, a diagnosis-specific navigator contacted and screened the patient with a COVID assessment tool. Documentation was forwarded to the primary oncologist/hematologist. The tool scored patients for surveillance and treatment needs. A score of 0-2 prompted phone assessment every 48-72 hours, and score of 3-5 required every 24-48 hour calls with physician involvement when appropriate. If score of ≥6, care was escalated to LCI nurse/physician for admission to AH acute care HAH or conventional inpatient admission. Results: From inception on 3/20/2020 to data review date of 12/2/2020, 974 LCI patients were identified as COVID-19 positive and reviewed for nurse navigation (Table). Of the 974, 488 were navigated. Given limited resources, patients with benign conditions were not assigned a navigator, though a similar process was created for sickle cell disease. Of the 974, 75 are now deceased. Only 25 are deceased among the 488 navigated. Conclusions: The COVID-19 pandemic presented unprecedented circumstances to our patients and their clinicians. LCI expeditiously put policies and procedures in place to mitigate the intersection of COVID-19 and cancer. The multidisciplinary response strategy liaising between AH HAH and LCI followed, assessed, and assisted LCI COVID-19 positive patients. With our embedded nurse navigation team’s specialized attention along with enhanced physician oversight and close collaboration with AH HAH, opportunities for care escalation or adjustments in cancer-focused care were promptly identified. Analysis is ongoing to elucidate the lower mortality rate observed among navigated patients.[Table: see text]
Socio-economic disparities and accessibility to age-appropriate screening tools.
Authors: Soror Noha , Keruakous Amany 
Published: June 2021

1529 Background: Pervasive racial and ethnic health disparities continue to be reported throughout the U.S. population. An increasing number of studies have discussed racial disparities in cancer statistics as well as socio-economic differences. The purpose of this study is to investigate sociodemographic health care disparities and the prevalence of cancer diagnosis in the context of challenges in medical services accessibility due to financial burden. Methods: Analysis of pooled cross-sectional data using 2017 Behavioral Risk Factor Surveillance System (BRFSS). Differences between our comparison groups were computed using chi square test for categorical values and t-test for continuous variables. Demographic factors were analyzed through weighted regression for accessibility to cancer treatment and prior cancer screening. Results: We report data from a total of 436,198 respondents to the 2017 BRFSS survey, with cancer prevalence 9.8% and higher prevalence of cancer among females and elderly population (70 years and older). Racial disparities differed significantly between respondents with and without history of cancer, with higher prevalence in Hispanic and multiracial minorities, 19% and 14%, respectively. We also report, differences in annual income are significantly associated with increased cancer prevalence in lower socioeconomic populations. Nineteen percent of participants who had annual income less than 25k were diagnosed with cancer. Additionally, analyzing the association between delayed medical care due to financial burden and its correlation with accessibility to age-appropriate cancer screening tools. We report significant differences in receipt of cancer screening among respondents, with consistently lower probabilities of receiving age-appropriate screening tools among participants who experienced delays in medical care due to cost, that applies to all screening tools. Among respondents who did not receive screening mammograms, 17% reported delays in medical care due to medical cost. Twelve percent of participants who did not receive screening colonoscopy suffered delays in medical care due to cost. Also, among participants who did not receive screening for prostate cancer with PSA testing, 11% reported delays in medical care due to cost. Conclusions: Health care disparities in cancer screening continue to persist including differences in socioeconomic classes and access to medical services. In this study, we report that patients with delayed access to medical services due to cost are not adequately receiving age-appropriate screening for cancer. Given the deleterious effects of delayed diagnosis and treatment of cancer, it is important that public health and clinical professionals utilize tools to improve cancer screening accessibility to minorities with socio-economic disparities.