bluuebunny/crossref_metadata_2025_split huggingface dataset:
Improving clinical trial consent form readability through artificial intelligence.
Authors: Litt Henry Kazunaru , Greenstreet Akman Emma , Idossa Dame , Florez Narjust , Velazquez Manana Ana I. 
Published: October 2023

109 Background: High literacy levels are needed to understand oncology clinical trial (CT) informed consent forms (ICF), which represents a barrier to enrollment of older adults and diverse populations. ChatGPT-4 is an artificial intelligence chatbot that responds to user prompts and can summarize large amounts of text. We tested whether ChatGPT-4 could simplify CT information from ICFs. Methods: On May 22, 2023, we searched clinicaltrials.gov for interventional, therapeutic, NIH-funded, CTs involving adults with the 14 most prevalent cancer types. Only CTs with available study protocols that were currently recruiting, “enrolling by invitation”, and “active not recruiting” were included. Trials that were diagnostic, preventative, or supportive were excluded. Publicly available ICFs from the resulting CTs were downloaded and analyzed. Using the ChatGPT-4 plugin askyourpdf.com, we asked ChatGPT-4 to review each ICF and answer 8 questions recommended by the NCCN for patients considering a CT in a 6th grade literacy level. Our prompt included the following 8 questions: “1) What are the treatments used in the clinical trial? 2) Has the treatment been used for other types of cancer? 3) What are the risks and benefits of this treatment? 4) What side effects should I expect and how will they be managed? 5) How long will I be in the clinical trial? 6) Will I be able to get other treatment if this doesn’t work? 7) How will you know if the treatment is working? 8) Will the clinical trial cost me anything?” Reading level (readability) was assessed for both the ICFs and ChatGPT-4’s question responses using the validated Flesch-Kincaid (FK), Gunning Fog (GF), and SMOG indices using the online Readable App. Data was summarized with descriptive statistics and t-test was used to compare text reading levels between ICFs and ChatGPT-4’s answers. Results: Our search yielded 83 therapeutic oncology CTs, of which 70 had publicly available ICFs. ChatGPT-4 successfully analyzed 66 of the 70 ICFs (94.3%). The mean text reading levels of its answers were 6.2 (95% CI: 5.9-6.5), 8.6 (95% CI: 8.2-8.9), and 9.2 (95% CI: 8.9-9.4) based on FK, GF, and SMOG indices, respectively. Of 70 ICFs, 54 (77.1%) contained text that could be evaluated for readability analysis and were included in the analysis. The mean text reading levels was 7.9 (95% CI: 7.7-8.1), 9.3 (95% CI: 9.1-9.6), and 10.5 (95% CI: 10.2-10.8) based on FK, GF, and SMOG indices, respectively. ChatGPT-4’s text responses had a significantly lower reading level compared to ICFs text for all three readability indices (FK: p<0.01, GF: p=0.02, SMOG: p<0.01). Conclusions: ChatGPT-4 presented key information from oncology CT ICFs at a 6th to 9th grade reading level, which was significantly lower than the original ICFs. While further studies are needed to assess ChatGPT-4’s accuracy, this study shows its potential as tool for improving patients’ understanding of oncology CTs.
Cancer screening and socioeconomic insecurity in FQHCs: The COVID-19 pandemic and state Medicaid expansion.
Authors: Star Jessica , Yabroff Robin , Han Xuesong , Shi Kewei Sylvia , Jemal Ahmedin , Bandi Priti 
Published: October 2023

112 Background: Previous studies reported improvements in multiple care quality measures, including cancer screening, in patients served in federally qualified health centers (FQHCs) located in Medicaid expansion states compared to non-expansion states. However, the COVID-19 pandemic disrupted delivery of routine primary care. Little is known about whether the COVID-19 pandemic disrupted or worsened cancer screening and socioeconomic insecurity in FQHC patients. Methods: Data on breast, cervical and colorectal cancer screening, and socioeconomic insecurity (food insecurity, financial strain, and lack of transportation to care) were obtained from the 2020 and 2021 Uniform Data System (UDS), a national report of care delivered by FQHCs. To balance clinic characteristics, the inverse probability of treatment weighting method was employed. Using a propensity score, the probability of being in a state that expanded Medicaid as of January 1, 2020, was measured. Clinics were then weighted conditional on the proportion best served in a language other than English and privately insured as well as rural location and which funding streams were received from section 330 of the Public Health Service Act. A weighted generalized estimating equation adjusted for random clustering of FQHCs within state with a Poisson distribution produced the prevalence ratios. Results: Between 2020-2021, approximately 2700 and 1300 clinics reported on cancer screening and socioeconomic insecurity. In 2020 and 2021, FQHCs in Medicaid expansion states had a higher patient screening prevalence for colorectal (2020: aPR: 1.16, 95% CI: 1.1-1.23; 2021: 1.13, 1.07-1.19) and breast (2020: 1.1, 1.05-1.17; 2021: 1.09, 1.03-1.14) cancer compared to clinics in non-Medicaid expansion states. Additionally, patient food (2021: 0.59, 0.36-0.97) and financial (2020: 0.57, 0.38-0.86; 2021: 0.58, 0.41-0.82) insecurity prevalence was lower in clinics in Medicaid expansion v. non-expansion states. Conclusions: State Medicaid expansion status was associated with higher cancer screening and lower socioeconomic insecurity within FQHCs during the COVID-19 pandemic. It remains an important policy intervention for vulnerable populations to receive care and mitigate disparities.[Table: see text]
Diagnostic delay among young women with breast cancer.
Authors: Fleshner Katherine , Quan May Lynn , Yang Flora , Xu Yuan ,   RUBY Site Investigators
Published: October 2023

117 Background: Breast cancer in women under 40 is uncommon, but often presents with greater disease burden and worse survival compared to the post-menopausal population. Given its infrequence, it is not well-understood how young patients initiate contact with care and how they are investigated prior to establishing the diagnosis. Whether young women experience diagnostic delay and whether it might impact survival is unclear. We aimed to describe the presentation of breast cancer among women <40 and to understand the diagnostic timeline using patient-reported outcomes. Methods: We evaluated patients in the Reducing the Burden of Breast Cancer in Young Women (RUBY) cohort, a pan-Canadian study recruiting women <40 with breast cancer at the time of diagnosis. Five online surveys detailing demographics, medical/family history and the diagnostic journey, distributed by e-mail at the time of recruitment, were used. All subjects who completed the surveys from 2015-2022 were included. A “patient delay” was considered >4 weeks from onset of symptoms to first contact with the healthcare system. A “system delay” was considered >3 weeks from presentation to first investigation, based on Canadian Partnership Against Cancer screening guidelines. Analysis was conducted using descriptive statistics. Results: There were 1148 patients included for analysis. Median age (IQR) was 37 (33.9, 39.0). Eighty-nine percent of patients had a symptom prompting assessment, of which most had a palpable mass (77.3%), and 27.7% had a painful mass. The median (IQR) number of weeks that patients waited was 2.0 (1.0, 8.0), and 364 patients (31.7%) experienced a patient delay. Most patient delays were attributed to lack of awareness of associated symptoms: 27.7% of patients were not concerned about their symptom and 3.9% were falsely reassured by practitioners. Other reasons included difficulty accessing timely care (3.6%; 37 patients) and conflicting priorities (2.1%; 21 patients). One hundred sixteen patients (10.1%) experienced a system delay. When asked about perceived timeliness of diagnosis, only 248 patients (24.4%) felt their time to assessment was not fast enough. Conclusions: The majority of young women with breast cancer present with palpable, often painful masses. A significant proportion of women experienced a patient delay, suggesting opportunities for increased education regarding presentation of early-onset breast cancer; After presentation to care, most women were investigated in a timely manner.
Empowering women’s health: Opportunity to bridge breast cancer screening to lung cancer screening.
Authors: Khalifeh Yara , Beirat Amir F. , Aljaras Razan , Alhaffar Dana , Karkash Ahmad , Hajj Ali Adel , Hanna Nasser H. , Ajrouch Ali 
Published: October 2023

121 Background: Lung cancer (LC) is the leading cause of cancer-related death for women in the United States (US). It surpasses the combined mortality rate of breast, cervical and ovarian cancers. Early detection of LC at stage I increases the 5-year survival rate to 80%. Lung Cancer Screening (LCS) is an effective tool for early detection. However, while 78% of women over 50 in the US undergo Breast Cancer Screening (BCS), only 6% of eligible women receive LCS. Methods: This is a retrospective study of all women diagnosed with primary LC presenting to Indiana University Simon Comprehensive Cancer Center from January 2019 to December 2020. We collected sociodemographic characteristics and information related to smoking history, LCS and BCS. We excluded patients with a prior history of lung or breast cancer who were under surveillance, and those with unknown smoking history. We assessed the BCS and LCS eligibility and utilization according to the U.S. Preventive Services Task Force latest recommendations. We also determined the utilization of LCS in women who have received BCS. Results: Among the 307 women who met the eligibility criteria, 87.6% were white, 51.8% had a Medicare insurance, 41.7% were ever-smoker, and 64.5% had advanced stages of LC (Stage II-Stage IV). Approximately half of our cohort was eligible for LCS, but only 20% received LCS. On the other hand, 72% were eligible for BCS and 58% of them underwent BCS. Among women who received BCS and were eligible for LCS, only25% underwent LCS. The median time from BCS to LC diagnosis was approximately 2.2 years. Among the 178 women who received BCS within one year prior to LC diagnosis, 27% underwent LCS. Among the remaining women who did not have LCS,66.7% of women were already in a later stage (Stage II-IV) at the time of LC diagnosis. Conclusions: Our study demonstrates that majority of women, who met the eligibility criteria for BCS and LCS, received BCS but not LCS prior to their LC diagnosis. This shows that despite the potential mortality benefit, LCS is still underutilized. Receiving LCS at the time of BCS can provide a valuable opportunity to increase LCS participation among eligible women and the potential of diagnosing LC at earlier stages.
Racial and geographic disparities in the use of molecular testing among older Medicare beneficiaries with lung cancer.
Authors: Qin Xuanzi , Chen Jie 
Published: October 2023

125 Background: The National Comprehensive Cancer Network (NCCN) guidelines recommend comprehensive molecular testing for newly diagnosed patients with metastatic non-small cell lung cancer (mNSCLC). However, the uptake of the next-generation sequencing (NGS) tests for NSCLC was low due to lack of insurance coverage. In 2018, the Centers for Medicare & Medicaid Services issued a national coverage determination to cover diagnostic laboratory tests using NGS for Medicare beneficiaries with advanced cancer. It is important to understand the current uptake of the NGS tests among older Medicare beneficiaries with lung cancer and examine the potential racial and geographic disparities in the use of NGS tests. Methods: From the random 20% sample of all Medicare beneficiaries, we selected Medicare beneficiaries who were 66 years and older and newly diagnosed with lung cancer in 2020. We excluded beneficiaries who were ever diagnosed with breast, colorectal, endometrial, lung, or prostate cancer before 2020 and beneficiaries who died in 2020. We further restricted our sample to those with a full year of Medicare Part A and B coverage and no month of Medicare Advantage coverage. We identified molecular testing for our lung cancer cohort using Medicare carrier and outpatient claims. We used two linear probability models to examine the relationship between race and the receipt of any molecular tests among all lung cancer patients (N=9,229), and the relationship between race and the receipt of panel tests among those received any molecular tests (N=1,842). We adjusted for age at the beginning of 2020, sex, Medicaid enrollment (low-income), geographic region, and common pre-existing chronic conditions (Alzheimer’s and related dementia, heart failure, chronic kidney disease, chronic obstructive pulmonary disease, diabetes, depression, ischemic heart disease, and arthritis). Results: Among 9,229 older lung cancer patients newly diagnosed in 2020, 1,842 (19.96%) of them received molecular tests. Among those 1,842 who received molecular tests, 709 (38.49%) of them received NGS tests, and the rest received single-gene tests only. In our regression analyses, we found Asian patients were 12.5-percentage point more likely to receive any molecular tests compared to White patients. Among those received any tests, Hispanic patients were 16.0-percentage point less likely to receive NGS tests over single-gene tests compared to White patients. We also found those residing in the South and the West were less likely to receive NGS tests over single-gene tests than those residing in the Northeast. Conclusions: Given the guideline recommendation and proportion of new mNSCLC cases among all new lung cancers, there was likely underuse of NGS tests. There were also racial and geographic disparities in the use of NGS tests.
Awareness of biomarker test timing and purpose in patients with non-small cell lung cancer (NSCLC).
Authors: Mohindra Nisha Anjali , Trosman Julia R. , Houseknecht Stefanie , Feliciano Josephine Louella , Sacks Ruth Lauren , Souter Benjamin , Waugh Wendi , Martin Jeremiah , Woodyard Jennifer , Schmidt Laura , Chang Cara , Rediske Anna , Zavala Sonia , Lycan Thomas William , Martin Nikki A. , Lile Ashley , Boehmer Leigh , Weldon Christine B. 
Published: October 2023

138 Background: Biomarker testing is necessary for optimal 1st line treatment selection in advanced NSCLC. Patient understanding of timing and purpose of biomarker testing is imperative for patient engagement in care but is challenging to achieve (1). The 4R Oncology model of patient self-management and timely care delivery has been shown to improve patient knowledge of timing/sequence of care in breast cancer (2) but has not been studied in NCLSC in relation to biomarker testing. 4R is being implemented at 5 centers (3 community and 2 academic) in NSCLC. We report baseline assessment of patient awareness of biomarker testing timing and purpose to inform 4R implementation. Methods: Pre-implementation surveys of patients with advanced NSCLC at 5 centers Aug – Dec 2022. Metrics are listed in Table. Results: Survey response rate: 46% (65/142). Respondents were 65% White, 42% high school educated or less, 46% with annual income ≤$30K. While all patients were aware of receiving non-biomarker tests, >40% were not aware of receiving biomarker testing (Table). About half knew why or how long they need to wait for results, but only 29% received this information from providers. Of those tested, the majority reported provider discussions of biomarkers or therapy selection and were clear about results or therapy selection. Awareness (eg, knowing to wait for results before therapy) was associated with receiving printed NSCLC materials (45% vs 7%, p<.01), education above high school (69% vs 41%, p=.03) and income >$30K (67% vs 32%, p=.01). Willingness to wait for test results was associated with knowing how to prepare for treatment while waiting (89% vs 46%, p<.01). Race did not impact these metrics. Conclusions: Considerable gaps exist in patient awareness of timing and purpose of biomarker testing. We refined the 4R model to emphasize biomarker timing in printed visual material, facilitate patient-provider discussions and engage patients in health maintenance while waiting for results. We revised 4R to a lower literacy level. Results will be reported when available. (1) Martin, Oncol Issues, 2022. (2) Trosman JCOOP 2021.[Table: see text]
Implementation of a national cancer subspecialist virtual consult pilot in an integrated health system.
Authors: Kolevska Tatjana , Brasfield Farah M , Kotak Dinesh , Presti Joseph , Harzstark Andrea , Carney Jennifer Fu , Rabrenovich Violeta , Riley-Bowen Megan , Hendricks Tiffany , Glinsky Isabel , Le Michele , McKinney Mishellene 
Published: October 2023

143 Background: Over 65,000 new cancer patients are diagnosed nationally each year at Kaiser Permanente (KP), with 12.7 million members in 9 states and the District of Columbia. KP developed the Cancer Expert Review Program (the Program) to connect oncologists with cancer subspecialists across the enterprise. The Program provides consultation and a chart note viewable by the patient within 2 business days. Methods: The Program was piloted from October 2022 to June 2023 for medical oncology patients with breast, gastrointestinal (GI), genitourinary (GU), sarcoma, thoracic, hematology, central nervous system (CNS), melanoma, head & neck, and gynecologic oncology (GYN) diagnoses or a need for molecular/genomic testing. Medical oncologists from Hawaii, Georgia, and Southern California submitted requests for virtual consults to designated cancer subspecialists using HealthConnect, KP’s EPIC system. Consulting physicians had direct access to the medical records for each patient, including pathology and imaging. Oncologists informed patients of the service and discussed the rendered opinion as part of shared decision-making. Implementation outcomes of feasibility and acceptability were evaluated. Providers were surveyed about perceptions of the service using an internally developed questionnaire. The time from consult request to completion was measured. Results: 108 consults (67.5%) were provided by individual subspecialists, while 22 consults (14%) were reviewed by multiple experts or a multidisciplinary team. 140 consults (87.5%) were completed within 2 business days. Of the 44 oncologists who requested a consult, 12 responded to a physician survey. 85% of physicians rated satisfaction with the service as “satisfied” or “extremely satisfied”. 75% said the advice helped to develop the treatment plan. Half of physicians reported the advice changed the original treatment or approach either “somewhat” or “to a great extent.” Half of physicians indicated that if this internal program were not available, they would have referred their patient to a non-Kaiser Permanente provider for a consultation. Conclusions: Implementation of a national cancer subspecialist virtual consult pilot within an integrated health system demonstrated the feasibility and acceptability of timely expert consults with high physician satisfaction. The Program facilitates subspecialist care in collaboration with the patient’s trusted general oncologist, keeping care close to home.Additional research is needed to understand the long-term implementation and quality outcomes of the Program.[Table: see text]
Who goes first? Patterns of cancer drug approvals across four major regulatory authorities: EMA, FDA, Health Canada, and PMDA.
Authors: Warner Jeremy Lyle , Mishra Sanjay , Hadfield Matthew James , Gyawali Bishal , Cowan Andrew , Khaki Ali Raza , Gage Samantha , Lythgoe Mark 
Published: October 2023

149 Background: New anticancer therapies have led to substantial improvements in prognosis across many cancers. Commercial access to a drug is not possible until the drug has received regional regulatory authority market authorization. In prior work (1), we found that European Medicines Agency (EMA) drug approvals frequently lagged US Food and Drug Administration (FDA) approvals from 2010-2019. Here, we expand the analytic time period to 2004-2023 and include two additional regulatory agencies – Health Canada (HC) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). Methods: Drugs with an anticancer indication and first global approval from 2004-2023 were preliminarily identified. Only drugs with an approval by all 4 regulators were included. For each drug, the first and last regulator’s initial approval dates were determined, and the interval between first and last approval was calculated. For drugs approved by all 4 regulators within 1 year (y), it was further determined whether they were considered first-in-class. Results: 209 drugs met the preliminary criteria, and 98 (47%) had approvals by all 4 regulators. The FDA was most commonly the first to approve (84 drugs), followed by PMDA (9 drugs), then EMA (5 drugs); HC was never first to approve. 43 of the FDA-first approvals (51%) were by the accelerated approval (AA) pathway; none of the EMA-first approvals were on the conditional marketing pathway. PMDA was most commonly the last to approve (62 drugs), followed by HC (21 drugs), the EMA (14 drugs), then the FDA (1 drug). The median (IQR) time between first and last regulator’s first approval was 2.4 y (1.3-3.5 y). Some drugs had >5 y between first and last regulator’s approval (Table 1). Conversely, only 16 drugs were approved by all regulators within 1 y, and only 1 drug (isatuximab) was approved by all within 6 months. Of the 16 drugs approved within 1 y by all regulators, 6 (37.5%) were first-in-class: asciminib, elotuzumab, idecabtagene vicleucel, inotuzumab ozogamicin, sotorasib, and trastuzumab emtansine. Conclusions: This study shows that patients with cancer in the US usually have access to new cancer drugs earlier than those in Europe, Japan, and Canada, at least in part due to AA pathways. Less than 8% of newly approved cancer therapies are approved by all 4 regulatory agencies within 1 y of first approval, with a lengthy median first-to-last delay that could exceed the life expectancy of many patients with advanced cancer. Greater global regulatory collaboration in the approval of new anticancer drugs is essential to ensure patients have aligned and coordinated access. (1) Lythgoe et al. JAMA Network Open 2022.[Table: see text]