bluuebunny/crossref_metadata_2025_split huggingface dataset:
How quickly are novel cancer therapies adopted after FDA approval and incorporation into EHR-embedded clinical decision support tools? A description of ordering patterns between users and non-users of an EHR-embedded oncology CDS tool.
Authors: Maniago Rebecca Lawrence , Ricottone Marcello , Sheikh Asad , Dias-Foundas Taylor , Huda Shawn , Calip Gregory Sampang 
Published: October 2023

508 Background: Oncology clinical decision support (CDS) tools provide up-to-date access to changes in treatment guidelines and notification of newly approved therapies to keep providers informed of rapid changes in the oncology environment. Our goal is to describe ordering patterns of oncologists who use an EHR-embedded CDS tool and those who do not after FDA approval for a new regimen combination and subsequent availability in the CDS tool. Methods: Flatiron Assist is a customizable CDS tool embedded in the electronic health record (EHR) to facilitate selection and documentation of National Comprehensive Cancer Network (NCCN) guideline concordant cancer care. This tool is updated on a monthly basis whereby updates to the NCCN guidelines are incorporated with subsequent communication delivered to users. For this retrospective description, we compared time in days to the first regimen order placed at 13 community oncology practices (348 MDs) using the CDS tool to 30 community oncology practices (294 MDs) not using the CDS tool. We focused on regimens ordered for the combination of nivolumab + platinum doublet (FDA approved on 3/4/22, incorporated into the NCCN guidelines on 3/16/22 and released in the CDS tool on 4/12/22) for neoadjuvant therapy in non-small cell lung cancer (NSCLC). Time to first order placed in practices that did and did not use the CDS tool was described as mean days with 95% confidence intervals (CI) and compared using linear regression with adjustment for number of MDs within a practice and robust standard errors from 4/12/2022 to 5/19/2023 which included 211 unique orders. Results: Of the 211 orders assessed during the observation window, the mean time to first order was 150 days (95% CI 118-182) for CDS tool users and 209 days (95% CI 177-242) for non-CDS tool users, favoring CDS tool users by 59 days (P=0.009, Table 1). Conclusions: Users of an EHR-embedded CDS tool ordered a new regimen sooner after FDA approval than non-users of the CDS tool. Limitations include the narrow sample size and evaluation of only one FDA approval. Future research will investigate whether the same benefit is seen for label expansions compared to net new regimen approvals as well as the impacts on outcomes and indicators of improved quality of care.[Table: see text]
Practice consolidation and distribution of U.S. medical oncologists, 2015-2022.
Authors: Erfani Parsa , Milligan Michael , Brooks Gabriel A. , Schleicher Stephen Matthew , Lam Miranda B. 
Published: October 2023

51 Background: From 2007 to 2017, oncology practices experienced high rates of consolidation. Greater market consolidation may facilitate greater efficiency but could also threaten access to care. Since 2017, the extent and effects of oncology consolidation have not been studied. Methods: Using Medicare data from 2015 to 2022, we calculated the number of medical oncologists (MOs) working in solo (1 MO), small (2-10 MOs), medium (11-24 MOs), and large (25+ MOs) practices. We estimated the level of MO consolidation in a Hospital Referral Region using the Herfindahl-Hirschman Index (HHI), a measure of consolidation ranging from 0 to 1 (with higher numbers corresponding to greater consolidation). We analyzed the distribution of MOs by measuring the association between the proportion of MOs practicing in a county and the county population. This association was quantified using the Gini coefficient, which ranges from 0 (equal distribution of MOs) to 1 (unequal distribution of MOs). We also created a multivariable linear regression model to assess the association of market factors with changes in HHI. Results: From 2015 to 2022, the number of MOs increased 14.5% (11,727 to 13,433), while the number of MO practices decreased 18.0% (2,774 to 2,276). During this period, the percentage of MOs working in solo or small practices decreased from 8.8% to 5.7% and 37.2% to 28.1%, respectively. The percentage working in large practices increased from 33.6% to 43.7%. The mean number of MOs per practice increased from 4.26 to 5.95 (p<0.001) and the median HHI increased from 0.3204 to 0.3480. The distribution of MOs did not change significantly at the county level: the Gini coefficient was 0.1288 in 2015 and 0.1254 in 2021 (p>0.05). In the multivariable analysis, regions with higher levels of baseline hospital consolidation (p<0.001), greater numbers of hospital beds per 1,000 persons (p=0.02), and lower levels of baseline MO practice consolidation (p<0.001) were associated with higher consolidation. Conclusions: Per HHI cutoffs of the Federal Trade Commission, the oncology market was highly consolidated in 2015 and underwent further consolidation by 2022. Despite rapid consolidation, the geographic distribution of MOs did not change substantially. Further research is needed to understand the impact of consolidation on cancer care access, quality, and cost. [Table: see text]
Capturing the patient’s voice to inform advanced clinical decision support for guideline-based cancer symptom management.
Authors: Lobach David F. , Cooley Mary E. , Halpenny Barbara , Dunnack Yackel Hayley , Boxwala Aziz , Abrahm Janet Lee 
Published: October 2023

510 Background: Electronic patient reported outcomes (ePROs) have become routine in cancer care; however, ePROs alone do not provide sufficient information to enable informed symptom management. Informed symptom management requires an awareness of patient context to reduce inappropriate or erroneous advice. In this project we asked: how can information be collected directly from patients to provide clinicians with detailed, contextually-informed, patient-specific, evidence-based recommendations to manage distressing symptoms, especially among patients with complex comorbidities. Methods: The literature states that text messages are the most effective way to engage patients in clinical data collection. We texted patients a link that led them to a Web-based questionnaire that asked them about their common cancer symptoms. Prototypes were tested with 9 cancer patients through structured interviews and think aloud sessions from which themes were identified. Feedback from these interviews was used to develop a patient data collection questionnaire that we iteratively refined through think aloud sessions with 9 cancer patients to achieve universal patient acceptance. We also engaged 28 oncology clinicians in semi-structured interviews to assess the clinical impact of the additional contextual information on the symptom recommendations they received. Results: Formative evaluation identified four themes: 1) make instructions brief, 2) use intuitive navigation buttons with labels, 3) focus on multiple-choice style questions, and 4) extract data from the medical record for patient verification instead of free text entry by patients (e.g., medications). Developers incorporated “more detailed” questions into the patient data collection questionnaire; additional questions were presented if the patient indicated moderate or greater severity of a given symptom. These detailed questions focused on characteristics of the symptoms (e.g. neuropathic or somatic pain), remedies a patient had already initiated for self treatment (e.g., laxatives for constipation), and comorbid conditions that could impact the safety of recommendations (e.g., fall risk). Clinicians indicated that the additional data collected from patients increased the value of the tailored recommendations for enhanced symptom management. Conclusions: Additional data collection from patients using standard text messaging enables clinical decision support algorithms to provide more individually tailored cancer symptom management recommendations. This study is limited in that the design enhancements have been tested with a small number of end-users in a laboratory setting. Acknowledgements: This project was 100% funded using Cancer Moonshot funding through Phase I and II SBIR contracts from the National Cancer Institute, Contract #75N91018C00022 and #75N91020C00019, respectively.
Comparisons of telemedicine and in-person visits: Utilization, oncology services and satisfaction among patients with breast cancer.
Authors: Freeman Jincong Q. , Zhao Fangyuan , Howard Frederick Matthew , Nanda Rita , Olopade Olufunmilayo I. , Huo Dezheng 
Published: October 2023

517 Background: Since the COVID-19 pandemic, telemedicine utilization has expanded in oncology settings and helps facilitate access to oncology services for breast cancer patients (pts). However, it remains unclear what types of oncology services are received via telemedicine and whether receipts of these services differ between telemedicine and in-person visits. Methods: We conducted a cross-sectional study surveying breast cancer pts in the Chicago Multiethnic Epidemiologic Breast Cancer Cohort from July-September 2022. Telemedicine (i.e., audio call [AC], video conference [VC], and both) and in-person visits were measured as having had a telemedicine and in-person visit with a provider in the past 12 months. Types of oncology services included treatment consultation, management of side effects/symptoms, review of lab, screening or pathology results, cancer genetic counseling, and clinical trial follow-up. We assessed common side effects/symptoms discussed during telemedicine or in-person visits. Satisfaction was assessed using a 5-point Likert scale. McNemar’s test was used to evaluate paired data on types of oncology services between telemedicine and in-person visits. Results: Of 1,160 pts (mean age 61.8 years, SD 12.0), 72.8% were White, followed by 19.7% Black, 4.5% Asian, and 3.0% Hispanic; 70.8% were privately insured and 23.0% on Medicaid/Medicare; 81.0% had stage I-III disease. Overall, 36.0% used telemedicine (of these, 65.0% VC, 22.7% AC, and 12.2% both) and 92.4% had in-person visits. Telemedicine users reported 93.9% and 95.5% of somewhat-to-extreme satisfaction with AC and VC, respectively, and 61.8% were likely or very likely to continue using telemedicine. In pts having both telemedicine and in-person visits, we observed differences between these visits in management of side effects/symptoms (15 vs. 54, p<.001), review of lab, screening or pathology results (26 vs. 90, p<.001), or trial follow-up (4 vs. 12, p=.046). However, there were no differences in treatment consultation (45 vs. 55, p=.317) or cancer genetic counseling (11 vs. 19, p=.144). Furthermore, BC pts who had in-person visits reported higher percentages of discussion of fatigue (50.3% vs. 41.1%), hot flashes (45.6% vs. 33.9%), lymphedema (26.0% vs. 19.6%), chemotherapy-induced neuropathy (24.9% vs. 19.5%), or nausea/vomiting (16.0% vs. 8.9%) than those used telemedicine; whereas a higher proportion of pts having discussed depressive symptoms via telemedicine than in-person visits (37.5% vs. 29.6%). Conclusions: In this multiethnic cohort of breast cancer pts, telemedicine use was prevalent and achieved high-level satisfaction. Our findings also suggest that both telemedicine and in-person visits are equally likely to include treatment consultation and genetic counseling, and telemedicine may be in greater need among breast cancer pts with mental health challenges.
Value, balance, impact: Factors contributing to the exodus of medical oncologists from clinical care.
Authors: Dixit Niharika , Chism David D. , Wilky Breelyn A. , Speers Corey Wayne , Levit Laura A. , Kirkwood Margaret Kelsey , Morgante Jim D. , Mulvey Therese Marie 
Published: October 2023

52 Background: A recent study of Medicare claims data suggested that 20% of oncologists left clinical roles in the last ten years. This exodus will add substantial indirect and direct costs to the healthcare system and reduce access to care. Understanding contributing factors can lead to solutions to this exodus. Methods: We performed a qualitative study of medical oncologists who recently left or self-identified as considering leaving clinical practice. Six focus groups were conducted from January and March 2023 with 26 oncologists. We used the whole-of-person workforce retention framework to inform the focus group guide. Focus groups were recorded and transcribed. Recordings were analyzed with open coding and grounded theory approach. Results: 26 participants participated in six focus groups: well-balanced for gender (14 male, 12 female), career stage (5 early, 14 mid, 7 late), practice setting (19 academic, 7 private practice), and predominantly urban (25) and one rural. Thematic saturation was achieved in these six focus groups, with 5 major themes identified: Value, Career development/impact, Burnout, Work life balance and Workload. Participants in all six focus groups reported feeling undervalued due to a lack of recognition for uncompensated effort, including education and clinical research, inadequate resources to provide clinical care, and/or mismatch of values. Symptoms of burnout, lack of work/life balance, and unsustainable workloads were present. Administrative tasks, documentation, electronic medical records, and prior authorization were not identified as significant contributors. Many respondents hoped to someday return to clinical care. Conclusions: Themes of value, balance, and personal impact in the field were identified as major reasons oncologists left or considered leaving clinical care roles. We found that burnout is a symptom of dysfunction in the healthcare system and not due to a lack of personal resiliency. Medical organizations like ASCO should focus on improving the workplace environments by helping sites to focus on valuing clinical care, education, research, and right-sizing oncology practices to support excellent cancer care and support medical oncology workforce.
Assessment of hospitalizations and cytopenia events among patients with extensive stage small cell lung cancer (ES-SCLC) receiving chemotherapy with trilaciclib.
Authors: Huang Huan , Tkacz Joseph , Moore Michelle , Lewing Benjamin , Huang Yecheng , Schinkel Jill , Parikh Ravi Bharat 
Published: October 2023

531 Background: Prior studies have reported that that nearly 75% of patients receiving chemotherapy for small cell lung cancer present a hospitalization associated with myelosuppression. Trilaciclib is a myeloprotective agent indicated for use prior to chemotherapy in ES-SCLC. Given the relative recency in trilaciclib approval (2/12/2021), this study assessed real-world outcomes associated with trilaciclib among patients with ES-SCLC. Methods: This study was a retrospective analysis of adult ES-SCLC patients diagnosed between 2020 and 2023 using the 100% Medicare Fee-for-Service and MORE2 Registry claims databases. Eligible patients met literature-based criteria for ES-SCLC using International Classification of Diseases, 10th Revision (ICD-10) diagnosis codes, received platinum/etoposide- or topotecan-based chemotherapy regimens after diagnosis, and were continuously enrolled ≥ 30 days preceding and following chemotherapy initiation. Patients were categorized into 2 mutually exclusive cohorts: 1) trilaciclib administered at chemotherapy initiation and with no granulocyte colony stimulating factor (G-CSF) received during chemotherapy, and 2) no trilaciclib administered during chemotherapy. Chi-square tests and student’s t-tests were used to assess statistically significant differences between groups on cytopenia events (based on the appearance of an ICD-10 diagnosis code) and all-cause hospitalizations during the post-index period. Data use agreements prohibit reporting of categorical outcomes of < 11 patients. Results: 132 trilaciclib (mean age 70.6, male 50.8%) and 12,305 non-trilaciclib patients (age 68.0, male 48.2%) were eligible for the study; median follow-up was 202 days. Compared to the non-trilaciclib cohort, patients receiving trilaciclib had a lower rate of hospitalizations per patient per month during follow-up (0.14±0.25 vs. 0.19±0.27; p <0.001). Within 90 days post-chemotherapy initiation, trilaciclib was associated with lower rates of hospitalization (21.2% vs. 32.4%; p <0.01) and febrile neutropenia (< 3% vs. 5.7%, p=0.01). Anemia (44.7% vs. 52.6%, p=0.07), neutropenia (9.1% vs. 14.9%, p=0.06) and thrombocytopenia (5.3% vs. 8.4%, p=0.2) were numerically lower for trilaciclib patients in the 90-day post-index period. Results were similar when the non-trilaciclib group was stratified by prophylactic G-CSF usage. Conclusions: This real-world study demonstrated that receiving trilaciclib prior to chemotherapy treatment was associated with a lower rates of hospitalizations and cytopenia events, suggesting trilaciclib may prevent adverse events associated with treatment for ES-SCLC.
Real-world comparative effectiveness and safety of pembrolizumab vs chemotherapy for previously untreated PD-L1≥50% metastatic non-small cell lung cancer.
Authors: Lu Brandon , Parmar Ambika , Luo Jin , Chan Kelvin K. 
Published: October 2023

538 Background: In the randomized KEYNOTE-024 trial, pembrolizumab demonstrated robust efficacy in patients with PD-L1≥50% metastatic non-small cell lung cancer (mNSCLC) with median overall survival of (OS) of 26.3 months and 13.4 months in the pembrolizumab and chemotherapy groups, respectively (hazard ratio (HR)=0.62). However, it is unclear how well this efficacy translates to effectiveness in routine practice. Thus, we sought to assess the real-world effectiveness and safety of pembrolizumab for patients with previously untreated PD-L1≥50% mNSCLC compared to platinum-based chemotherapy. Methods: This was a population-based, retrospective cohort study of mNSCLC patients receiving first-line platinum-based chemotherapy (historical controls) from April 1, 2013, to January 17, 2018, or first-line pembrolizumab (cases) from January 17, 2018, to March 31, 2021, in Ontario, Canada. Baseline characteristics and outcomes were ascertained from linked administrative databases. The primary outcome was OS, assessed using Kaplan-Meier and Cox proportional hazards regression methods. Secondary safety outcomes included hospitalization, emergency department visits, specialist visits, and adverse events. To adjust for baseline differences, propensity-score matching was used to match the case and control cohorts (1:1). As a sensitivity analysis, we analyzed OS by histology subgroups (squamous versus non-squamous). Results: A total of 2,284 matched patients were included in our propensity score-matched cohort. The median OS in the pembrolizumab group (13.0 months, 95% confidence interval (CI): 11.8-14.6) was significantly longer than the chemotherapy group (9.2 months, 95% CI: 8.0-10.0), with a HR of 0.81 (95% CI: 0.71-0.92). Though pembrolizumab was also associated with improved OS in both patients with squamous (HR=0.77) and non-squamous histology (HR=0.81), pembrolizumab patients reported significantly more adverse events, specialist visits, and higher 1-year cumulative incidence of direct hospitalizations (11.5% vs 6.8%, p=0.0002). Conclusions: The results of this study confirm the survival benefit of pembrolizumab monotherapy for previously untreated mNSCLC patients with PD-L1≥50% in routine practice, though with increased toxicity and diminished benefit in the real world.
Enabling real-world cancer care quality surveillance and analytics through a novel population-based statewide linked database.
Authors: Spees Lisa P. , Albaneze Natasha , Baggett Christopher D. , Green Laura , Johnson Katie , Morris Hayley , Salas Ana I. , Olshan Andrew F , Wheeler Stephanie B. 
Published: October 2023

545 Background: Population-based linked datasets are vital tools to generate real-world evidence (RWE) that can inform interventions and policies to improve cancer care quality and outcomes. The novel University of North Cancer Information & Population Health Resource (CIPHR) links statewide cancer registry data, public and private health insurance claims, and provider- and area-level data since 2003, representing more than 80% of North Carolina’s large, diverse cancer patient population. This scoping review included all articles that have used CIPHR data (N=44) to characterize the breadth of RWE generated and to identify further opportunities for population-based care quality surveillance. Methods: Articles published between 2012-2022 were categorized by cancer site(s) of focus, exposure variables, and outcomes examined across the cancer care continuum. For each article, notable results and conclusions were extracted and summarized, including statistically significant associations between patient-level factors (e.g., demographics, clinical variables, insurance type, distance to providers), provider-level factors (e.g., specialties, facility type, networks), system/policy-level factors and outcomes. Results: Of the 44 articles included, findings were reported across 23 unique cancer sites; 9 articles reported results aggregated across multiple cancer sites. Across the cancer care continuum, the majority of articles’ outcomes were categorized as focused on treatment and survivorship (n=25), with most examining treatment initiation and/or adherence (n=13). Other common outcomes included costs of care (n=8) and mortality/survival (n=8). Fewer articles focused on cancer screening (n=2), recurrence (n=1), long-term care use (n=1), or incidence (n=1). The cancer site most frequently examined was breast cancer (n=19), followed by colorectal (n=6), cervical (n=5), and uterine cancers (n=5). The majority of articles focused on racial/ethnic, rural/geographic, and socioeconomic inequities in care and outcomes, as well as multilevel predictors of observed trends. Conclusions: These findings demonstrate the value of creating and sustaining robust, longitudinal, population-based databases to facilitate the generation of RWE that can be used to monitor cancer care delivery trends, including cancer inequities that warrant intervention and policy attention. Lessons learned from more than a decade of analytics utilizing this unique data resource highlight opportunities to explore less frequently studied cancers and outcomes; motivate targeted implementation of equity-focused interventions and policies responding to trends; and inform development of similar resources in other states.