bluuebunny/crossref_metadata_2025_split huggingface dataset:
Racial distribution of clinical trial participants in the United States.
Authors: Patel Monaliben , Hess Lisa M. , Su Eric Wen , Li Xiaohong , Bruno Debora S. 
Published: June 2021

e18516 Background: Lack of diverse representation in clinical trials negatively impacts the cancer survival of patients and populations unaccounted for in clinical research. Efforts such as the 1993 NIH Revitalization Act have focused on improving the diversity of trial participants in the US. This retrospective study evaluated the racial distribution of oncology clinical trial participants using data published in clinicaltrials.gov from Jan 2010 through Dec 2020. Methods: I2E of Linguamatics (IQVIA, Inc), a natural language processing software, was used to identify participant race in oncology trials. Data extracted included trial identifier, year of completion, sponsor, cancer type, and race. Studies were limited to academic, cooperative group and government studies headquartered in the US. Clinical trial results were compared to the racial distribution of SEER 2010 data using z-test. Results: Data from 35,686 patients (14,220 enrolled to 236 phase 2 and 21,471 enrolled to 47 phase 3 trials) were available for analysis. A summary by race is provided in the Table, excluding unknown, which represented 8.5% of phase 2 and 3.5% of phase 3 trials. The proportions of white/black patients enrolled to phase 2 and phase 3 trials beginning in 2010-12 were 84.4%/11% and 83.1%/9.9%, respectively (total enrollment 84.9%/9.6%). For trials beginning in 2015-17, white/black enrollment represented 88.5%/8.1% of patients enrolled to phase 2 and 86.4%/10.1% of patients in phase 3 trials. Black patients represented 9.6% of all trial participants, in contrast with the SEER data where 12% of all patients were black (p < 0.001). For lung cancer trials, black participants represented only 7.9% of all trial participants whereas in breast cancer trials, 10.2% of participants were black, versus the SEER data specific to these tumor types (black patients represent 10.9%/11.5% of lung/breast cancer diagnoses between 2013 to 2017, both p < 0.01). Conclusions: This study suggests that over the past decade most races (other than white) have been significantly underrepresented in US oncology clinical trials, and is even more pronounced for black patients with lung cancer. Based on this analysis, there is no evidence that trial enrollment distribution, particularly of white versus black participants, has changed since 2010. Data are limited to the relative lack of studies reporting results that began enrollment after 2017. These findings suggest that the development of new strategies to improve the recruitment of racial minorities to oncology clinical trials are warranted.[Table: see text]
Relationship between insurance status and diagnosis of cutaneous immune-related adverse events.
Authors: Chang Michael , Krasnow Nira A. , Blum Amy E. , Pahalyants Vartan , Murphy William S. , Yoon Jaewon , Reynolds Kerry Lynn , Thompson Leah L. , Chen Steven T. 
Published: June 2021

e18535 Background: Cutaneous immune-related adverse events (cirAEs) are among the most common side effects of immune checkpoint inhibitor (ICI) therapy. While insurance status has been shown to influence outcomes in patients treated with ICIs, its impact on cirAE management remains underexplored. We therefore evaluated insurance status in patients with cirAEs, examining its effect on rate of and time to cirAE diagnosis. Methods: Using billing data, we retrospectively identified patients who initiated anti-PD-1/PDL-1 and/or anti-CTLA-4 therapy at Massachusetts General Hospital between January 1, 2016 and March 8, 2019 (n = 2,459) for possible cirAE. Eligible cirAEs included reactions attributed to ICI by the clinician, consistent with established morphologic categories. For each patient with confirmed cirAE (n = 358), we abstracted oncologic history, cirAE features, and insurance status. Associations between insurance and cirAE diagnosis outcomes were assessed via logistic and linear regression, and adjusted for age, sex, race, ICI type, cancer diagnosis, cirAE type, and significant covariates ( P< 0.05). Results: Of the 2,459 patients who received ICIs, 2,419 (98.4%) had documented insurance status. Most ICI recipients had Medicare (n = 1,119; 46.3%) or private insurance (n = 1,156; 47.8%) relative to Medicaid (n = 104; 4.3%) or other government insurance (e.g. Tricare) (n = 40; 1.7%). We found that 358 (median age 64 years, 40.5% female) developed a cirAE. Among cirAE patients, 175 had Medicare (48.9%), 174 had private insurance (48.6%), 6 had Medicaid (1.7%), and 3 had other government insurance (0.8%). The most common cirAEs across insurance types were maculopapular rash, pruritus, and eczematous and lichenoid eruptions. In the multivariable analysis, ICI patients with Medicare insurance had a higher rate of cirAE diagnosis (adjusted odds ratio: 2.41, 95% CI: 1.00, 5.90, P= 0.05) relative to Medicaid patients. In addition, in terms of time to cirAE diagnosis at dermatology visit, Medicare insurance was associated with longer delays, with a linear regression coefficient of 132.2 (95% CI: 4.78, 259.6; P= 0.04). No significant associations were found between other insurance types and cirAE diagnosis outcomes. Conclusions: Our study shows that patients with Medicaid are less likely to be diagnosed with cirAE relative to those with Medicare, despite delays in diagnosis, when controlling for all other demographic/oncologic factors. Ultimately, these findings are reassuring that despite insurance differences, patients with cirAEs are receiving suitable care and appropriately seen by dermatologists. As insurance coverage for specialists can vary widely, these initial findings are a promising indicator that patients with cirAEs are well-connected within healthcare systems.
Kaposi sarcoma among adults enrolling for HIV care in a large HIV clinic in Nigeria: 2006-2017.
Authors: Akanbi Maxwell Oluwole , Bilaver Lucy , Achenbach Chad , Hirschhorn Lisa , Agbaji Oche , Murphy Robert , Adekolujo Samuel O 
Published: June 2021

e18539 Background: Expanded access to antiretroviral therapy (ART) has led to a dramatic decline in Kaposi sarcoma (KS) among people initiating HIV care globally. In Nigeria, the country with the second-largest global HIV population, ART coverage increased from 11% in 2006 to 57% by 2017. The impact of Nigeria’s ART expansion of KS risk is unclear. We examined trends in KS risk among patients enrolled for HIV care in a large clinic in Nigeria from 2006-2017. Methods: We analyzed data of 16,431 adults (age ≥18 years) enrolled for HIV care from January 1, 2006, to December 31, 2017, in a large clinic in Jos, Nigeria. KS at enrollment was defined as KS recorded in the electronic health record within 30 days of clinic enrollment. Time trends were compared among three periods: 2006-2009, 2010-2013, and 2014-2017 (Mean national ART coverage 16%, 33%, and 50% respectively), using the Chi-test trend test and logistic regression models to identify factors independently associated with KS. The study was approved by the local institutional Institutional Review Board (IRB) and ruled exempt by the IRBs of Northwestern University and Harvard School of Public Health. Results: The study population had a mean age 35.1 (standard deviation, SD 9.5) years, and were 65.7% female (n= 10,788). The median first CD4 cell count was 192 (IQR 84-320), 215 (IQR 98-344), and 222 (IQR 94-353) in 2006-2009, 2010-2013, and 2014-2017, respectively. The overall KS prevalence at entry was 0.59 % (95% CI 0.48-0.72). KS prevalence was lowest for patient entering care during 2006-2009 (0.39%, 95% CI 0.29-0.53), increased to 1.12% (95% CI 0.82-1.52) in 2010-2013 and declined to 0.72% (95% CI 0.42-1.20) from 2014-2017 (Chi2 for trend, 12.14, p<0.01). Adjusting for age, sex, and CD4 T-cell count KS prevalence was significantly higher in 2010-2013 compared to 2006-2009 (Table). Conclusions: Despite ART expansion, KS at enrollment showed no significant decline. The low CD4+ cell count, across all periods, indicates delay in enrollment for HIV care, which increases KS risk. Interventions aimed at early HIV diagnosis and linkage to ART are critical to KS risk reduction in this population. Factors associated with Kaposi sarcoma at HIV care enrollment in Jos, Nigeria (2006-2017).[Table: see text]
Survival disparities in top five cancers in the United States: A population based study.
Authors: Nutalapati Snigdha , Chen Quan , Huang Bin , Myint Zin 
Published: June 2021

e18545 Background: Health inequity is an important field in cancer research and it is vital to determine the underlying etiologies to eliminate health disparities. Health insurance differences in survival outcomes have been reported for patients residing in California and New Jersey. Likewise, we aim to explore the impact of variations in insurance status and demographic factors on survival outcomes in patients with the top five cancers in the United States using a nationwide cancer registry. Methods: Surveillance, Epidemiology, and End Results (SEER) 18 program was queried to identify patients with a primary diagnosis of lung, breast, colorectal, prostate cancer, and melanoma from 2007 to 2016. Patient characteristics included are age (≥20 years), sex, marital status, metropolitan or non- metropolitan residence, insurance status (private vs. Medicaid vs. uninsured), education level, stage at diagnosis, and survivals. Descriptive and survival analyses were performed using Pearson Chi-square, Kaplan-Meier and Cox regression tests. Results: A total of 935,916 patients were included, of which 344,022 (37%) had breast cancer, 209,762 (22%) prostate cancer, 151,553 (16%) colorectal cancer, 151,468 (16%) lung cancer, and 79,111 (8%) melanoma. Most patients were aged > 50 years (76%) and 55% were female. Privately insured accounted for 83% of all patients, 13% had Medicaid and 4% were uninsured. Male gender, married, patients with higher education level, residing in metropolitan areas were more likely to have private insurance (p < 0.001) compared to female gender (84.3% vs. 81.2%), unmarried (90.1% vs. 68.7%), subjects with very low to moderate education level (88.2% vs. 80.8%), and ones residing in non- metropolitan areas (83.4% vs. 76.3%). Patients with private insurance were more likely to be diagnosed at localized stage compared to Medicaid insured and uninsured (59.2% vs. 38.2% and 36.6%; p < 0.001). On bivariate and multivariate analyses across of all five cancers, age > 50 years (HR 2.0; p < 0.001), male gender (HR 1.3; p < 0.001), single (HR 1.3; p < 0.001), Medicaid insurance (HR 1.2; p < 0.001), and uninsured (HR 1.3; p < 0.001) were associated with worse overall survival than age < 50 years, female, unmarried, and privately insured. Conclusions: Along with noticeable survival disparities by insurance status in lung, breast, colorectal, prostate and melanoma, we noted that privately insured patients are more likely to be presented at an earlier stage compared to patients with Medicaid and uninsured. Additionally, elderly age, lower education level, unmarried and low socioeconomic status had a negative impact on survival. Multidisciplinary care team efforts are critical in mitigating these health disparities.
Satisfaction with care and attention to salient concerns by race in a diverse national sample of young women with breast cancer.
Authors: Carroll Bridget Rose , Zheng Yue , Ruddy Kathryn Jean , Emmons Karen , Partridge Ann H. , Rosenberg Shoshana M. 
Published: June 2021

e18561 Background: Young women with breast cancer (BC) have unique issues, including fertility, genetic, and emotional health concerns; these may sometimes be inadequately addressed by providers. Given documented disparities in BC care and outcomes, we sought to explore whether provider attention to these issues differs by race, as well as to examine racial differences in satisfaction with care among young patients with BC. Methods: The Young & Strong Study was a cluster randomized trial of an educational and supportive care intervention at 14 academic + 40 community oncology practices across the US enrolling women with newly diagnosed BC at age ≤45 and their providers. Patients completed surveys at baseline, 3, 6, and 12 months after enrollment. Race was self-reported at baseline. Provider attention to fertility, genetics, and emotional health was evaluated by medical record review. The proportions of patients with attention to these concerns by 3 months was compared by race (white, Black, Asian, multi-racial/other/unknown) using Fisher’s exact tests. Satisfaction with care was assessed with the Patient Satisfaction Questionnaire-18 (PSQ-18) at 3 months. Median scores for each of 7 PSQ-18 subscales (1-5 scale, higher scores=more satisfaction) were compared by race with the Kruskal-Wallis test. Results: 465/467 (99.6%) of enrolled patients had evaluable data. 77% were white, 12% Black, 4% Asian, and 7% multiracial/other/unk. Median age at diagnosis was 40 (range: 22-45) years. Provider attention to genetics (≥85%) and emotional health (≥90%) was high across groups, and there were no differences by race in attention to fertility, genetics, or emotional health (Table). Among 359/465 women (77%) who completed the PSQ-18, median subscale scores ranged from 3.5-4.5, indicating high levels of satisfaction with care. For the PSQ-18 technical quality domain, median scores were lower (p=.03), indicating less satisfaction, in Black and Asian women (4.0) and higher in white women (4.5). Median scores for other PSQ-18 domains (general satisfaction, interpersonal manner, communication, financial, time spent with doctor, accessibility) did not differ by race. Conclusions: Satisfaction with care was high and issues related to fertility, genetics and emotional health were addressed by providers in the majority of young women in our study, with minimal differences by race. These patients were all enrolled in a clinical trial and had access to high-quality care, limiting the generalizability of our findings. Larger, population-based studies in more diverse settings are warranted. Clinical trial information: NCT01647607. Attention to psychosocial concerns by race. [Table: see text]
Phase III randomized clinical trials global distribution and funding: Trends and disparities.
Authors: Pinheiro Karina , Ribeiro Mauricio , Gadotti Luiza Lara , Marson Fabiane , Lopes Carlos Diego Holanda , Saddi Rodrigo , Alessi Joao Victor Machado , Katz Artur 
Published: June 2021

e18563 Background: Phase III clinical trials (PIIICT) constitute the cornerstone of the progress and development of new therapeutic strategies. However, their complexity and costs in a scenario of limited funding sources impose important limitations in their scope and reach. Methods: We searched in clinicaltrials.gov to identify PIIICT evaluating pharmacological interventions in adjuvant, neoadjuvant and metastatic settings between 2010-2020 in breast, cervix, colorectal cancer (CRC), lung, melanoma, prostate and penile cancer. Trials identified were categorized according to disease site, funding source and world region/country (R/C). Case incidence in 2020 was collected from the IARC website. Results: Of 825 clinical trials, 72.7% were industry-sponsored (IS). Trials by R/C, not including multicentric studies (61.8%): (A) USA 76 trials, 53.9% non-industry sponsored (NIS); (B) Europe/UK 112, 59.8% NIS; (C) Asia (excluding China) 62, 27.4% NIS and (D) China 183, 43.7% NIS. There was a statistically significant association between location and funding source (p= 0.0003). NIS source was detected in higher proportion of trials ongoing in regions A and B (59%). IS was statistically less frequent in uterine cervix/penis (42.8%) and CRC (49.6%) IS was significantly higher in lung and prostate trials (both 81%) (p<0.0001). Table summarizes our results by tumor sites. We also found a statistically significant association between the incidence of malignancies in the selected primary sites and the amount of registered clinical trials, overall (p<0.0001) and IS as well (p<0.0001). The database is under expansion to include other disease sites as well as other geographic areas separately (Africa, Russia, South America, India, and Oceania). Cervix and penile results were combined given their biological and epidemiological similarities. Conclusions: There is a significant disparity between the number of clinical trials and tumor prevalences as well as among the distribution of IS trials funding.[Table: see text]
Cancer care during COVID-19: Data from 157 patient organizations.
Authors: Warwick Lorna , Baugh Elisabeth , Cardoso Fatima , Giles Rachel H. , Filicevas Alex , Fox Jesme , Oliver Kathy Rose , Reid Frances , Isaacson Jenny , Spiegel Andrew , Ventura Roberta , Sheahan Nicole , MacKay Clara 
Published: June 2021

e18564 Background: Representatives from 8 global cancer coalitions/alliances, representing 650 cancer patient groups and the interests of over 14 million patients have come together during the pandemic to review and evaluate the patient-perspective impact. Cancer services have faced challenges as a result of COVID-19, including suspension of screening and diagnostic services; delays in diagnosis leading to higher mortality rates; cancellation/deferral of life-saving treatments; changes in treatment regimens and suspension of vital research. For organisations that provide support to cancer patients, declining income, the need to reduce staff and move to virtual working practices has put extra strain while demand for support due to the pandemic has increased. Methods: 5 coalitions surveyed their member organisations. A number of coalitions consulted their members by individual surveys or consultations. Results: A survey of 157 organisations representing advanced breast, bladder, lymphoma, ovarian and pancreatic cancer patient groups from 56 countries found that 57% experienced an average increase of 44% in patient calls and emails. 45% reported that their future viability may be under threat because of the impact of COVID-19 on income. Examples of good practice were reported where healthcare systems have acted to protect patients and cancer services. These include the introduction of COVID-free centres, separation of cancer patients from those who may have COVID-19, and the introduction of virtual and telemedicine services. Organisations have also introduced new ways of working including virtual psychological support services and app-based support groups. These best practices should form part of a global plan of action for future health crisis. Conclusions: Collaboration between patient advocacy organisations, governments and health services is needed to ensure the ground lost to the COVID-19 pandemic is regained. Action is required to restore cancer services safely and effectively without delay. Additional resources for organisations that support cancer patients are required to ensure that they continue to provide vital services. Finally, a global plan of action for cancer is required to meet the challenges of any future health crisis.
Impact of Medicaid expansion on pancreatic cancer care: A difference-in-difference analysis.
Authors: Hamad Ahmad , Eskander Mariam , Li Yaming , Bhattacharyya Oindrila , Fisher James L , Oppong Bridget A. , Obeng-Gyasi Samilia , Tsung Allan 
Published: June 2021

e18567 Background: The Affordable Care Act (ACA) increased insurance coverage for low-income individuals, which should potentially lead to better access to care and improved oncological outcomes. This study seeks to evaluate the impact of Medicaid expansion (ME) on care for pancreatic ductal adenocarcinoma (PDAC). Methods: Patients who were uninsured or on Medicaid and diagnosed with PDAC between 2004 and 2017 were queried from the National Cancer Database (NCDB). Two different expansion cohorts were included: early expansion states and 2014 expansion states. For early expansion states, the time period of pre-expansion was 2004-2009 and post-expansion was 2010-2017. As for the 2014 expansion states, the pre-expansion period was from 2004-2013 and post-expansion period was from 2014-2017. Patients in non-expansion states formed the control group. A difference-in-difference (DID) analysis was used to assess the association of ME with stage of diagnosis, treatment and survival for each expansion cohort. Results: In both early and January 2014 expansion states, there was an increase in overall Medicaid coverage (Early: DID = 0.29, 2014: DID = 0.37; P < 0.001), in particular for non-Hispanic Black and Hispanic Black patients (Non-Hispanic Black: Early: DID = 0.11, 2014: DID = 0.11; P < 0.001, Hispanic-Black: 2014: DID = 0.20; P = 0.003). There were no differences in early stage diagnosis (Early: DID = 0.02, 2014: DID = -0.02; P > 0.05). There was an increase in the number of patients receiving surgery (Early: DID = 0.05; P = 0.001, 2014: DID = 0.03; P = 0.029) but no difference in time to surgery among patients receiving surgery upfront (Early: DID = 1.75, 2014: DID = 0.38; P > 0.05). There was no difference in 30-day readmission post-surgery (Early: DID = 0.003; 2014: DID = -0.00007; P > 0.05) or 90-day mortality (Early: DID = -0.007, 2014: DID = -0.035; P > 0.05). Moreover, there was no difference in receipt of chemotherapy (Early: DID = 0.01, 2014: DID = 0.005; P > 0.05) or time to chemotherapy for patients receiving neoadjuvant chemotherapy (Early: Early: DID = 9.62, 2014: DID = 0.01; P > 0.05). Finally, there was no difference in receipt of palliative care among stage IV patients in both cohorts (Early: DID = -0.004, 2014: DID = 0.004; P > 0.05). Conclusions: This study suggests that after ME, PDAC patients were more likely to be insured and had increased access to surgical care. Future, studies should evaluate the implications of improved surgical access on clinical outcomes such as mortality.