bluuebunny/crossref_metadata_2025_split huggingface dataset:
Impact of oncology clinical pharmacist intervention on clinical trial enrollment in The U.S. Oncology Network’s MYLUNG Consortium.
Authors: Koselke Elizabeth , Hough Shannon , Howell Josh , Robert Nicholas J. , Neubauer Marcus A. , Bullock Susie A. , Walberg Jennifer M. , Rammage Melissa , Butrynski James E. , Hakimian David , Jotte Robert M. , Meshad Michael W. , Ali Kashif , Waterhouse David Michael , Coleman Robert L. , Evangelist Makenzi Colleen 
Published: June 2022

1503 Background: The Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Consortium (MYLUNG) clinical trial platform aims to advance the use of precision medicine in non-small cell lung cancer patients through a series of prospective and iterative clinic trials. “Protocol 2” is evaluating the patient and tissue journey of newly diagnosed lung cancer patients presenting for care. Timely patient accrual to oncology clinical trials is a known practice challenge. The US Oncology Network recently implemented a clinical pharmacist (ClinReview) to provide remote clinical services to support Protocol 2 enrollment. Methods: An oncology-trained clinical pharmacist remotely reviewed chemotherapy regimen orders and a weekly custom recruitment report within six community network practices (n = 149 physicians). The ClinReview pharmacist identified, screened, and assisted with recruitment of eligible patients for enrollment in the MYLUNG study. Relevant and concise patient data were provided to the on-site research team to facilitate ease of enrollment. Enrollments and intervention data were tracked to monitor the impact of the pharmacist intervention. The primary outcome of monthly enrollment was evaluated using a paired t-test. Results: Over a 6-month period, the ClinReview pharmacist screened 367 potentially eligible patients, 325 patients were recommended for enrollment, and 103 patients (32%) were consented and enrolled. Enrollment due to this ClinReview intervention increased monthly and ranged from 5 in first month to 33 enrollments in month 6. Average monthly enrollment was significantly greater after ClinReview intervention (3.4 patients/month vs. 6.8 patients/month; p = 0.008). Of the 154 patients recommended for enrollment that were not enrolled, 104 (68%) exceeded their eligibility window allowed by the trial, 15 (10%) were deceased or enrolled into hospice care, 10 (6%) declined trial participation, and 25 (16%) transferred care or were treated at outside facilities. Conclusions: We demonstrate that incorporation of an oncology clinical pharmacist in clinical research teams significantly enhanced clinical trial enrollment. The remote pharmacist easily adapted into clinic workflows in community practices. Validation across a broader spectrum of differentially resourced oncology practices will be conducted as the MYLUNG clinical trials platform is executed. [Table: see text]
Time to biopsy of screening mammography-detected abnormalities: Evaluating the impact of same-day services implemented during the COVID-19 pandemic.
Authors: Klinger Kimberly , Dontchos Brian , Mercaldo Sarah , Achibiri Janeiro , Wang Gary , Miles Randy , Lamb Leslie , Lehman Constance Dobbins 
Published: June 2022

1511 Background: Screening mammography programs often require patients undergo multiple visits (screening exam, diagnostic exam, and biopsy) before tissue diagnoisis of screen-detected abnormalities. During the COVID-19 pandemic, same-day breast imaging services were leveraged to decrease the number of visits following abnormal screening exams. Specifically, in May 2020, we implemented an immediate-read screening mammography program to synergize with our pre-existing same-day breast biopsy program, such that every effort was made to perform diagnostic imaging during the same visit after an abnormal screening mammogram. This study aims to evaluate the impact of these same-day breast imaging services on time and number of patient visits to undergo breast biopsy after an abnormal screening mammogram. Methods: Consecutive screening mammograms performed during normal business hours pre- (6/1/16 to 5/30/17) and post-implementation (6/1/20 to 5/30/21) of same-day services were identified. Patient demographics, imaging and biopsy results, and visit dates were extracted from the medical record. Multivariable logistic, linear, and ordinal regression models estimated with generalized estimating equations were fit to assess the association of period (pre- versus post-implementation), patient age, and race and ethnicity (White versus races other than White) with having a same-day biopsy (biopsy on the same day as the abnormal screening exam), number of days to biopsy, and number of visits. Adjusted odds ratios (aOR) and beta estimates (aBeta) of each covariate and corresponding 95% confidence intervals (CI) were estimated. Results: A total of 409/25,922 (1.6%) of patients (median age 61, IQR 50-70) pre-implementation and 221/20,452 (1.1%) patients (median age 62, IQR 49-71) post-implementation had screen-detected abnormalities leading to diagnostic breast imaging and biopsy. Median number of days from screening to biopsy decreased from 16 days pre-implementation to 5 days post-implementation (p < 0.001). Pre-implementation, 86.8% of patients required 3 visits between screening and biopsy, while post-implementation only 23.1% required 3 visits (p < 0.001). Compared to pre-implementation, the post-implementation period was associated with increased odds of undergoing same-day biopsy (aOR 20.7, 95% CI 8.3-51.7), p < 0.001), fewer days from abnormal screening mammogram to biopsy (aBeta -13.3, 95% CI -15.7 to -10.9, p < 0.001), and fewer visits (aOR 0.05, 95% CI 0.02-0.09), p < 0.001), controlling for age and race and ethnicity. Conclusions: Same-day breast imaging services decreased time and patient visits between abnormal screening mammogram and breast biopsy. Same-day services implemented out of necessity during the COVID-19 pandemic should be continued after the pandemic has subsided to improve timeliness of care.
Preliminary analysis of an expanded access study of the fixed-dose combination of pertuzumab (P) and trastuzumab (H) for subcutaneous injection (PH FDC SC) for at-home administration (admin) in patients (pts) with HER2-positive (HER2+) breast cancer (BC) during the COVID-19 pandemic.
Authors: Dang Chau T. , Tolaney Sara M. , Riaz Fauzia , Tan Antoinette R. , Tkaczuk Katherine H. R. , Yu Anthony Francis , Liu Jennifer , Fung Anita M. , Yang Anna , Day Bann-mo , Rugo Hope S. 
Published: June 2022

1515 Background: Standard of care for HER2+ early/first-line metastatic BC (EBC/MBC) is P + H and concurrent chemotherapy (CT); PH FDC SC offers faster, more convenient admin vs intravenous (IV) P + H. COVID-19 has caused unprecedented strain on healthcare systems and disruption to cancer care; treatment (Tx) at home may: enable pts to continue cancer Tx; reduce exposure to COVID-19; free up hospital resources. This study’s main objectives: to enable continuity of care during COVID-19; to assess safety of PH FDC SC given at home. Methods: This is an ongoing single-arm, hybrid, decentralized clinical trial (NCT04395508). Pts with HER2+ EBC/MBC who completed concurrent CT with P + H IV and are receiving/about to receive maintenance P + H IV, PH FDC SC, or H SC are switched to PH FDC SC given at home by a home health nursing provider (HHNP) until disease progression, unacceptable toxicity, pt withdrawal, or physician recommendation (pts with EBC will complete ≤18 cycles). The study endpoint is safety. A subset of pts took part in HARRIET, a substudy of at-home cardiac surveillance with artificial intelligence-guided cardiac ultrasound and optional 6L ECG acquired by an HHNP. Results: Data for 114 pts (1 male) were available at cutoff (Jan 19, 2022): 18 (16%) completed Tx; 20 (18%) discontinued; 76 (67%) remain on study; 79 (69%) had a COVID-19 vaccine while on study. Median age was 49 years; pts were balanced between EBC (n = 55, 48%) and MBC (n = 59, 52%); received a median of 6 (EBC) and 8 (MBC) cycles; and were from metropolitan (n = 109), urban (n = 4), and rural (n = 1) areas. 11 pts tested COVID-19-positive during the Tx phase: 8 continued Tx after appropriate COVID-19 Tx and/or quarantine. Safety is summarized in the table. No new adverse events (AEs) emerged due to home admin. AEs of special interest were grade (gr) 1–2: admin-related reactions (n = 76, 67%), hypersensitivity (n = 5, 4%), cardiac dysfunction (n = 4, 4%), except 1 case of gr ≥3 diarrhea. AEs leading to study Tx discontinuation or interruption/dose reduction occurred in 3 (3%) and 15 (13%) pts. A subset of 7 pts completed at-home cardiac surveillance testing; quantitative assessment of left ventricular ejection fraction was feasible in 3 (43%); 5 (71%) preferred at-home surveillance to clinic. Conclusions: In this preliminary analysis, safety of PH FDC SC at home was consistent with the established P + H safety profile, indicating that PH FDC SC at home is a viable option for continuing BC care during and beyond COVID-19. Clinical trial information: NCT04395508. [Table: see text]
Reducing inpatient mortality in patients with cancer through multidisciplinary review and targeted interventions.
Authors: Shah Manan P , Garrigues Sarah K. , Khaki Ali Raza , Hansen Jennifer , Divi Vasu , Blayney Douglas W. 
Published: June 2022

1524 Background: Excess inpatient mortality is a marker of poor quality in cancer care. We developed a multidisciplinary mortality review committee to review each inpatient death to determine key drivers of mortality and develop targeted interventions to reduce our inpatient mortality index. Methods: Through retrospective review, inpatient deaths were identified at Stanford Health Care for patients with an ICD10 cancer diagnosis regardless of inpatient service. Details of each hospitalization were reviewed by a quality consultant and subsequently reviewed by a physician quality team member to identify opportunities for improvement. Most cases were then discussed in a monthly multidisciplinary committee meeting. The committee analyzed key drivers of inpatient mortality, communicated suggestions to the patient’s outpatient and inpatient attending physicians, and/or identified opportunities for systemic change. The resulting targeted interventions were tracked using the observed versus expected mortality ratio for inpatient deaths over time. Results: From May 2017 through August 2021 we reviewed 528 inpatient oncology deaths. Patients’ median age was 65 years, and the median length of stay was 8 days. 73% of patients had metastatic cancer, and 28% received chemotherapy within 14 days of death. 25% of patients had a prior ED visit, and 35% had a prior hospitalization within 30 days of admission. Only 26% of patients had an advanced directive on record at time of death. Opportunities for improvement were identified for 60% of cases (Table). Interventions have aimed to increase advance care planning conversations and documentation, develop predictive models for cancer-related readmissions and mortality, expand outpatient services for urgent symptoms, and expedite transitions to hospice. Conclusions: Understanding key drivers for preventable inpatient mortality through a multidisciplinary review process identified targeted interventions that have successfully contributed to reduction of the inpatient cancer mortality index.[Table: see text]
Will COVID-19 directives to reduce regularly scheduled physical examinations affect recurrence detection in patients with early breast cancer?
Authors: Beltran-Bless Ana-Alicia , Alshamsan Bader , Alzahrani Mashari J. , Hilton John Frederick , Samuel Vicky , Baines Kelly-Anne , Pond Gregory Russell , Vandermeer Lisa , Clemons Mark J. , Larocque Gail 
Published: June 2022

1532 Background: The COVID-19 pandemic has significantly reduced routinely scheduled in person assessment and examination of early breast cancer patients (EBC). To assess if this is likely to impact the detection of recurrent disease, we reviewed recurrence patterns of EBC patients enrolled in a survivorship program that adheres to ASCO guidelines. Methods: Charts of EBC patients transferred through a single center Wellness Beyond Cancer Program (WBCP) and who subsequently had a breast cancer recurrence between February 1, 2013 and January 1, 2019 were reviewed. Patient, tumor and treatment characteristics were evaluated. Results: Of 206 patients eligible for the current study, 41 patients had ipsilateral breast recurrences (19.9%), 135 had distant recurrences (65.5%) and 30 had contralateral new breast cancers (14.6%). Ipsilateral breast recurrences were detected by the patient in 53.7% (22/41) and by routine imaging in 41.5% (17/21). The majority of distant recurrences (125/135, 92.6%) were detected via patient-reported symptoms. Contralateral breast primaries were detected by patients 16.7% (5/30) or by routine imaging (83.3%, 25/30). Only 2/206 (1.14%) recurrences/new primaries were detected by healthcare providers at routinely scheduled follow-up visits. There was a statistical difference in recurrence detection between image detected vs. self-detected in the following factors: grade 3 (26.5% vs 51%, p < 0.007), triple negative breast cancer (3.9% vs. 15.1%, p = 0.03), HER2 disease (18.4% vs. 9.8%, p = 0.04). Conclusions: Despite following ASCO follow-up guidelines for routinely scheduled follow-up appointments with physical examination, healthcare providers rarely detect recurrence disease. While reduced in person visits may affect other aspects of follow-up (e.g., toxicity management), it appears unlikely, provided patients attend regular screening tests, that reduced in-person follow-up is associated with worse breast cancer-related outcomes during the COVID-19 pandemic. [Table: see text]
CONTINUUM: A pilot care transition intervention for hospitalized patients with advanced cancer.
Authors: Lage Daniel E , Schmelkin Alane , Cohn Julia , Miller Laurie , Kuhlman Caroline , Krueger Elizabeth A. , Olivier Kara Marie , Haggett Dana , Ritchie Christine , Greer Joseph A. , El-Jawahri Areej , Nipp Ryan David , Temel Jennifer S. 
Published: June 2022

1534 Background: Patients with advanced cancer are frequently hospitalized and experience burdensome transitions of care after discharge. Interventions to address patients’ symptoms, support medication management, and ensure continuity of care after discharge are lacking. We sought to demonstrate the feasibility and acceptability of CONTINUUM (CONTINUity of care Under Management by video visits) for this population. Methods: We conducted a single-arm pilot trial (n = 54) of CONTINUUM at Massachusetts General Hospital (MGH). The intervention consisted of a video visit with an oncology nurse practitioner (NP) within 3 business days of hospital discharge to address symptoms, medication management, hospitalization-related issues, and care coordination. Prior to discharge, we enrolled English-speaking adults with advanced breast, gastrointestinal, genitourinary, or thoracic cancers experiencing an unplanned hospitalization who were receiving ongoing oncology care at MGH and being discharged home without hospice services. We defined the intervention as feasible if ≥70% of approached and eligible patients enrolled and if ≥70% of enrolled patients completed the intervention within 3 business days of discharge. At 2 weeks after discharge, patients rated the ease of use of the video technology and stated whether they would recommend the intervention. NPs completed post-intervention surveys to assess fidelity to the intervention protocol. Results: From 01/07/21 to 05/28/21, we enrolled 54 patients (77.3% of patients approached). Of the enrolled patients (median age = 65.0 years; 59.3% and 22.2% had advanced gastrointestinal or thoracic cancers, respectively), 83.3% of enrolled patients received the intervention within 3 business days of discharge. Patient rating of the ease of use of video technology was a mean of 7.8 out of 10, with 71.4% stating they “agreed” or “strongly agreed” that they would recommend the intervention. NP post-intervention surveys revealed that visits focused on symptom management (85.7%), followed by addressing post-hospital care issues (69.0%). At 30 day follow up, 38.8% were readmitted within 30 days of discharge, and 12.2% died within 30 days of discharge. Conclusions: We found that CONTINUUM, which consists of an NP-delivered video visit soon after hospital discharge addressing patients’ symptoms, medications, and care coordination, represents a feasible and acceptable approach to provide post-discharge care for hospitalized patients with advanced cancer. Future studies will test the efficacy of the intervention for reducing hospital readmissions. Clinical trial information: NCT04640714.
Cancer health disparities in the state of Georgia: African American oncology care.
Authors: Karki Nabin Raj , Zarkua Kristina , Bano Kulsum , Chahin Michael , Keruakous Amany R. 
Published: June 2022

1546 Background: Approximately 58,970 new cancer diagnoses are projected for 2022 in Georgia (GA), contributing to 18,750 deaths. African Americans (AA) make up about one-third of Georgia’s population compared to 14% of the national population. Cancer survival rates are lower for AA than non-AA for almost all cancer types. Biological factors do not account for all these differences. We explore the impact of racial disparities on cancer care in Georgia. Methods: We used 2020 behavioral risk factor surveillance system (BRFSS) data to capture patient-reported data on various demographic and health coverage variables. Oncology patients in the stage of Georgia were selected for our analysis. We evaluated the effect of racial disparities on clinical services received. Results: In the state of GA, 9,090 participants responded to the 2020-BRFSS, of which 400 partcipants had a history of cancer diagnosis other than skin cancer. Males and females comprised 37% and 63%, respectively. AA represented 15.8% of the respondents. The majority of the oncology respondents reported having health care coverage (96%) and having insurance coverage for all cancer treatments (96.8%) despite having 81.9% of the participants unemployed. Compared to non-AA, AA participants reported lower rates of health insurance payment for cancer treatment (84% v 99.3%, P = 0.0022) and lower levels of annual incomes (percentage of annual income <50,000$/year was 72.3% vs 51.5%, P = 0.0151). AA participants were four times less likely to have full coverage for cancer-related treatment than non-AA (odds ratio=4.31). There was no statistically significant difference in secondary education rates, health care coverage, the inability to see a physician due to cost, receipt of summary of treatment or written instructions, denial of insurance coverage due to cancer, and clinical trial participation. Participants with at least secondary education were more likely to have full insurance coverage for all cancer treatment expenses (P = 0.0206). Conclusions: Among cancer patients in Georgia, income rates were lower in AA than in non-AA. They were also less likely to have full coverage for cancer-related treatment. Analysis suggests secondary education increases the likelihood of having full insurance coverage. Education and income disparity may have a bearing on the accessibility and quality of cancer care. Addressing these inequities on a societal level will be key in ensuring high-quality oncology care for all. [Table: see text]
Development of an electronic health record registry to facilitate collection of Commission on Cancer (CoC) metrics for patients undergoing surgery for breast cancer.
Authors: Lyu Heather G. , Kantor Olga , Laws Alison , McDonald James , Pham Lisa , Dominici Laura Stewart , Vincuilla Julie , Raut Chandrajit P. , Danilchuk Bryan , Novak Lara , Parker Tonia , King Tari A. , Mittendorf Elizabeth A. 
Published: June 2022

1549 Background: Accurate and efficient data collection is a challenge for quality improvement initiatives and clinical research. We describe the development of a custom electronic health record (EHR) based registry to automatically extract structured Commission on Cancer (CoC) axillary surgery specific metrics from a custom synoptic note template included in the operative reports for breast cancer patients undergoing surgery. Methods: The “Smart” functionality of our enterprise-based EHR system was leveraged to create a custom Smart phrase to capture axillary surgery specific variables. A multidisciplinary team developed structured data elements correlating to each axillary surgery-specific variable. These data elements were then included in a note template for the operative report. Each variable could be aggregated and converted into a single flat database through the EHR’s reporting workbench and serve as a live, prospective registry for all users within the EHR. Results: The final axillary surgery-specific note template in a synoptic format allowed for efficient and easy entry and automatic collection of breast cancer specific metrics. From initial adoption in February 2021 through December 2021, there were 1,254 patients who underwent breast surgery with axillary surgery. The operative notes allowed for automatic capture of metrics from 60.5% (n = 759) of patients. Data capture improved from 37.6% in the initial adoption period of six months to 86.2% in the last five months. Capture rate in December 2021 was 98%. Conclusions: We were able to demonstrate successful implementation of provider driven structured data entry into EHR systems that permits automatic data capture. The end result is a custom synoptic note template and a real-time, prospective registry of breast cancer-specific CoC metrics that are robust enough to use for quality improvement initiatives and clinical research.