bluuebunny/crossref_metadata_2025 huggingface dataset:
Being Present-CML: A mindfulness-based intervention for patients with chronic myeloid leukemia taking tyrosine kinase inhibitors.
Authors: Schoenbeck Kelly L. , Dhruva Anand , Lee Albert , Parikshak Anand , Smith Catherine Choy , Shah Neil P. , Atreya Chloe Evelyn
Published: September 2024

353

Background:
Tyrosine kinase inhibitors (TKIs) prolong the lives of patients with chronic phase chronic myeloid leukemia (CP-CML) but can cause side effects that negatively impact quality of life. Mindfulness-based interventions (MBIs) have improved symptoms in patients with solid tumors but have not been studied in patients with CP-CML. We sought to determine if a MBI is feasible and acceptable to patients with CP-CML and explored its preliminary efficacy.
Methods:
Being Present-CML is a prospective, single-arm clinical trial of an 8-week, online MBI developed for patients with GI cancers (Atreya, et al. PLoS One, 2018) and adapted to include qigong. Participants were recruited from a single academic institution. Eligibility included adult patients with CP-CML taking TKIs. Participants played audio-guided meditations at least 5 times per week on a secure website and participated in weekly, instructor-led meditation and qigong sessions on Zoom. Feasibility was assessed through measurement of recruitment and attrition. Adherence was determined by web capture. Acceptability was determined from surveys and qualitative interviews. Preliminary efficacy was evaluated by patient-reported outcome measures (PROMs) at baseline (week 0) and post-intervention (week 8). Descriptive statistics and two-tailed paired t-tests (p<0.05) were used to summarize the data. Interim results were presented previously; here we report the final results.
Results:
Between October 2020-September 2021, 121 eligible participants were approached to participate, and 46 patients (38%) consented. The median age was 49.5 years (range 23-75), 54.3% (n=25/46) were male, and 82.6% (n=38/46) were non-Hispanic White. At time of study start, 82.6% (n=38/36) were taking dasatinib, 84.7% (n=39/46) had a BCR-ABL1 PCR transcript ≤1%, and a median time since diagnosis of 70.5 months (range 1-234). Of 46 participants, 35 (76.1%) completed end of study procedures. The median number of audio meditations listened to per participant was 28.7 with an average of 4.1 per week. The median number of 8 weekly classes attended and/or recordings viewed per participant was 7 (range 0-8). At baseline, participants had an average NCCN Distress Thermometer score of 4.86 (range 0-8), which improved to 3.5 by week 8 (p=0.02). Nearly all participants would recommend the to others (median score of 9 on a 1-10 scale; 10=extremely likely).
Conclusions:
Patients with CP-CML taking TKIs found the MBI to be feasible and acceptable. PROM results suggest potential for distress reduction in this patient population.

Clinical trial information:
NCT04605211

.
Optimizing workflows for the use of NCCN Distress Thermometer in real-world settings: Insights from a systematic review.
Authors: Agarwal Priyal , Powell Caleb , Patel Pranav , Kesireddy Meghana
Published: September 2024

372

Background:
Patients with cancer and their caregivers are at an increased risk of psychosocial distress that can negatively impact health outcomes and quality of life. Several organizations including NCCN, American College of Surgeons Commission on Cancer, and ASCO, recommend routine psychosocial distress screening and referral. However, many patients are not routinely screened for psychosocial distress, leading to missed intervention opportunities. The NCCN Distress Thermometer (NCCN DT) is the most commonly used self-reporting tool, but its use varies significantly due to differences in practice, workflows, and resources. This systematic review aims to capture elements of the workflow in screening and referral using the NCCN DT, with the goal of providing building block(s) for the implementation that can be adapted to different settings.
Methods:
A systematic review of full-text manuscripts published from 2013 was conducted using MEDLINE, EMBASE, and CINAHL. Studies describing implementation protocols were included. Systematic reviews and commentary articles were excluded. Additionally, studies conducted outside the US, non-English publications, and studies assessing associations of distress scores with disease burden were excluded. Attributes related to the implementation of screening and referral pathways were extracted.
Results:
From an initial screening to 1,219 articles, 12 studies were included in the final analysis. There was variation in the targeted populations, with three cancer centers implementing NCCN DT screening and referral protocols system-wide, while others focused on specific cancer types/ clinics. Screening was conducted by various personnel, including medical assistants, front-end staff, and nurse/ nursing assistants, with differences in screening frequency, and mode (paper, telephone, and tablet). Different referral workflows based on distress severity were adopted in multiple studies (n=4), with an array of referral services employed.
Conclusions:
The implementation of NCCN DT screening and referral pathways varies across the literature. While standardization is desirable, some variation is essential to accommodate the differing availability of resources and personnel for effective screening and referral. This review identifies foundational blocks and considerations for developing customized NCCN DT screening and referral protocols that align with specific needs and available resources of the practice.
Use of ambient AI scribing: Impact on physician administrative burden and patient care.
Authors: Doshi Gury K. , Jensen Terry Lynn , Graziano Anna , Enenmoh Chinenye , Lindsey James
Published: September 2024

418

Background:
Medical documentation is necessary to describe encounters for clinical and billing purposes. The increasing time required for medical documentation is contributing to provider stress and burnout. Physicians divide their time and attention between patients and the electronic health record (EHR), negatively impacting the patient physician relationship.
Methods:
49 physicians from Texas Oncology participated in a pilot from November 2023 to April 2024 using Deep Scribe (DS) ambient artificial intelligence (AI) technology to document patient clinic visits. Subspecialties of medical oncology, radiation oncology, urology, and breast surgery completed opinion surveys pre and post pilot. Provider adoption, weekly usage, satisfaction scores were measured. Evaluation and management (E&M) diagnosis codes for office visits conducted pre-pilot were reviewed for over 27,000 patient encounters and compared to over 4,500 DS patient encounters. Hierarchical condition category (HCC) codes captured via DS AI were compared to manual capture of billing codes in the pre-pilot period.
Results:
77% of providers adopted DS AI technology during the pilot. Median turnaround time for notes was less than 3 minutes. Average satisfaction score was 81%. 91% of providers stated DS was easy to use. 60% of providers believed DS improved the quality of documentation. Providers reported on average 1.5 hours per provider time saved per week. The average number of billed diagnosis codes for non- DS patients was 3 per patient. For the DS patients, the average billed diagnosis per patient was 4.1. Diagnosis codes were categorized as cancer, and other non-cancer HCCs using the CMS-HCC model category version 22. Of the top ten HCC categories, cancer diagnosis codes were better captured by manual coding, whereas DS captured more non-cancer HCC codes across multiple systems, most significantly in endocrine and cardiovascular systems.
Conclusions:
Data from this pilot study shows physicians reported DS AI improved quality of their documentation and saved physicians’ time. Billing data shows increase capture of non-cancer HCC codes. Use of AI in medical documentation can decrease physician burden and improve quality of patient care.

E&M Diagnosis Codes
Non-Deep Scribe
Deep Scribe

Patient visit count
27,236
4,584

Diagnosis code count
82,231
18,702

Average
3.0
4.1

Median
2
3

Mode
2.0
1.0
How quickly do patients with cancer view the results of their imaging studies?
Authors: Kuperman Gilad , Lipitz-Snyderman Allison , Chimonas Susan , Polubriaginof Fernanda C. G.
Published: September 2024

419

Background:
The 21
st
Century Cures Act requires electronic health data to be available to patients. However, such data are useful to patients only if they access it. For example, imaging data can indicate the effectiveness of treatment and progression of disease and engagement with this information empowers patients to become more active in their care. While prior studies have explored the prevalence and timing of patient access to clinical notes, the timing of patient access to other data types remains unknown. We analyzed how rapidly oncology patients access the results of their imaging studies.
Methods:
Memorial Sloan Kettering Cancer Center (MSK) is a cancer center in New York that provides 700,000 imaging studies annually. At the time of this analysis, MSK had an internally developed patient portal, MyMSK, which notified patients via email about the presence of new data in the portal. The default timing for notifications was daily at 8 a.m. (patients could change notifications to be real-time, but very few did). We selected an arbitrary 7-day period (4/1/2023-4/7/2023) for analysis. For that week, for all imaging studies performed at MSK, we measured the time from when the report was available in the database (and thus available to the patient in MyMSK) to the time the report was read by either a patient or a proxy. The day the imaging study was performed was defined as “Day 0”. We determined (i) the proportion of imaging study reports that were read by 8 a.m. on Day 1, i.e., before any notification was sent to the patient, (ii) the proportion of reports that were read on Day 1 between 8 a.m. and 5 p.m., (iii) the proportion of reports that were read after 5 p.m. on Day 1, and (iv) the proportion not yet read by 8/23/2023 (when the data were collected).
Results:
In this one-week period, a total of 7,110 patients had 10,298 imaging studies. The average age of the patients was 61.4 years, 61.3% were female, 85.5% were non-Hispanic, 75.8% were White, and 95.1% reported English as their preferred language. Of the 10,298 imaging reports, 3203 (31.1%) were read before 8 a.m. on Day 1, 2090 (20.3%) were read between 8 a.m. and 5 p.m. on Day 1, 2389 (23.2%) were read after 5 p.m. on Day 1, and 2616 (25.4%) were not read as of 8/23/2023.
Conclusions:
This analysis indicates that a substantial proportion of cancer patients seek the results of imaging studies very soon after the tests are performed. Almost a third of the time, the patient read the report before any notification arrived. In oncology, it is easy to imagine patients frequently refreshing their portal to see if results have been posted. It is vital for provider organizations to understand the eagerness with which patients await results. Organizations may also want to develop methods to answer questions patients may have about their results prior to speaking with providers; this may be a key opportunity to leverage emerging artificial intelligence techniques.
Effect of implementing an integrated oncology dashboard on clinical and operational quality in a community-based cancer network.
Authors: Sanyal Amit , Couture Lauren , Cropp Brett F. , Taylor Evie , Bianchi Michael J. , Remick Scot C.
Published: September 2024

420

Background:
MaineHealth Cancer Care Network (MHCCN) encompasses nine regional cancer centers and one affiliate cancer center located in rural south-central Maine and New Hampshire. MHCCN developed an integrated operational dashboard to improve clinical and operational performance. In this report, we detail improvements in a variety of quality metrics after implementation of the dashboard.
Methods:
Extracts from various non-interoperable data sources were integrated using a MS Power BI platform to create the dashboard. Divided into pages—
summary, growth, service excellence, innovation and transformation
—the dashboard provides searchable and regularly updated snapshots of numerous relevant metrics in these domains. Access to the dashboard was extended to all clinical and operational staff, with data reviewed bi-monthly in provider and operational meetings. The dashboard played a pivotal role in identifying MHCCN’s 2023 key performance indicator, specifically the electronic health record (EHR)-based TNM staging, along with notable care gaps such as underutilization of the NCCN distress thermometer (DT) for psychosocial distress assessment. Bottlenecks to timely care delivery were similarly identified by leveraging time to treatment data in the service excellence page. Targeted quality improvement initiatives were devised to address the gaps.
Results:
EHR-based structured TNM staging by providers improved from 29% in Fiscal Year (FY) 2022 to 47% in FY 2023 and 64% in FY 2024 year-to-date (YTD). Use of the NCCN DT improved from 1.1% in FY 2022 to 30.9% in FY 2023 and 49.9% in FY 2024 YTD. Process changes resulting from identifying delayed scheduling of PET scans as a bottleneck reduced the lead time from scan ordering to scan appointment from 18 days (January-July 2023) to 9 days (January-April 2024). Leveraging access to monthly productivity data through the dashboard, provider compensation reform incorporating production-based incentives was launched in July 2023, improving throughput and access as well as provider recruitment and retention. Information transparency from a freely accessible dashboard contributed to a 0.67-point gain in the 2023 Gallup provider core engagement CE3 score, reaching 3.45 (on a five-point scale).
Conclusions:
Clinical and operational metrics are often fragmented across different platforms, leading to inefficiencies and limited insights. Creating a system-wide integrated quality dashboard improved data visibility, provider engagement and led to measurable improvement in quality metrics across various domains.
Development and validation of a natural language processing algorithm using electronic health record data to identify patients with breast cancer with low social support.
Authors: Kroenke Candyce , Aoki Rhonda , Mammini Lauren , Cronkite David , Alexeeff Stacey , Jones Salene M. W. , Kushi Lawrence H. , Strayhorn Shaila , Mogk Jessica , Mosen David , Carrell David
Published: September 2024

421

Background:
Social support is important to the management of breast cancer treatment. Our team has developed data from electronic health record (EHR) data into structured ‘concept groups’ that will form the basis for the development of EHRsupport, a computable, EHR-based measure of social support. We report the evaluation of these concept groups against chart review as a part of our validation.
Methods:
We built a natural language processing (NLP) algorithm on clinical notes in 7,989 women diagnosed from January 2006 to September 2021 with invasive breast cancer. We identified and developed 10 concept groups from unstructured data: 1) living situation, 2) marital/partner status, 3) parenthood status, 4) visit support (accompanied patient to ≥1 visit, patient attended alone at ≥1 visit), 5) friends/other support, 6) explicit positive or negative mentions of social support, 7) mention of a deceased person, 8) transportation issues, 9) relationship conflict or stress, and 10) social isolation. We validated concept groups against the charts of 100 patients randomly drawn from the broader patient population (nonoverlapping with the training data set) also around the time (-1 to +3 months) of diagnosis.
Results:
Concept group data availability ranged from 1.3% social isolation to 98.3% for living situation. Specificity and negative predictive values were moderate to high for all concept groups. Sensitivity and positive predictive values were moderate to high for concept groups with high data availability (Table) and lower for concept groups with low data availability.
Conclusions:
Data on social support have been available since the advent of Epic in 2006 and our NLP-based algorithm accurately captured data within the EHR that were systematically collected supporting the development of a clinical tool that can be used to identify patients at risk of low social support.

EHRsupport concept groups, data availability (n=7,989), and evaluation vs. chart review.

Availability (%)
Sensitivity
Specificity
PPV
NPV

Living situation (e.g., alone or not)
98.3
100
92
61
100

Partner/spouse
92.0
85
100
100
81

Parenthood status
88.8
95
80
93
83

Visit support
82.9
92
77
96
59

Positive mentions social support
*46.9
75
100
100
70

Negative mentions social support

33
99
67
96

Friend/other support
46.8
81
81
79
83

Deceased person
39.9
86
97
95
90

Transportation issues
14.6
80
85
22
99

Relationship conflict/stress
7.7
25
95
29
94

*Availability of positive and negative mentions of social support.
Radon mitigation in Native communities: A partnership between a tribal health clinic and University of Wisconsin Carbone Cancer Center.
Authors: LoConte Noelle K. , Heubel Vera Judy , Brunner Beth , Maloney Jessica , Cianciara Mary , Lundin Michael
Published: September 2024

44

Background:
Radon is the second leading cause of lung cancer in the United States, and the Native communities in Wisconsin bear an outsized burden of lung cancer. Radon testing is attainable for these communities, but the cost of one-time mitigation is high and out of reach for many. The University of Wisconsin Carbone Cancer Center (UWCCC) partnered with the Stockbridge-Munsee Band of the Mohican Nation (S-M) Health Center to test homes for radon levels and mitigate (repair) those structures when levels were high to mitigate a structural barrier of health. Prior tests had suggested 10% of homes across Wisconsin test “high” for radon (above 4 pCi/L). The mean radon level among tested homes in Wisconsin is 5.7 pCi/L (American Lung Association, Radon Testing Disparities: Wisconsin, 2022).
Methods:
The project was co-developed with the UW and S-M. A key partner was the Wisconsin Radon Program, housed at the Wisconsin Department of Health Services. We aimed to educate, test for radon, and mitigate all homes that tested high for radon. Education, promotion of the program and testing were done in collaboration between state, university, and tribal officials. The environmental health and community health coordinators at S-M was the key person for distributing and ensuring the return of kits. Mitigation was performed by a private certified contractor over the project. We used descriptive statistics to evaluate the percentage of Wisconsin homes that tested high for radon in our sample. We also surveyed community members about their satisfaction with the mitigation contractor.
Results:
This project was done from April 2023 to April 2024. Staff reported educational sessions were successful in improving their knowledge of radon and testing and mitigation procedures. The S-M had 1822 enrolled tribal members at the start of the study. A total of 85 kits were distributed, with 64 returned (75.3% return rate). Of those, 42 of 64 tested positive for high radon in the home (65.6%), much higher than the expected 10% positive rate. The mean radon level among all homes was 14.1 pCi/L (0-111.6pCi/L) and 18.7 pCi/L among homes that tested positive. All homes testing high have completed radon mitigation. All reported their homes could not have been mitigated without this collaboration. The community was satisfied with the services of the certified contractor.
Conclusions:
Radon levels were much higher than anticipated in Native lands in Wisconsin and may explain higher rates of lung cancer. Cancer centers are key partners in addressing high radon levels and mitigating structural determinants of health among Native communities, such as with housing quality.
Cancer care delivery in prisons: From barriers to best practices.
Authors: Manz Christopher , Nava-Coulter Brett , Voligny Emma , Wright Alexi A.
Published: September 2024

49

Background:
Cancer is the leading cause of death in US prisons. Incarcerated patients with cancer have 92% higher 5-year mortality than the general population with cancer, but little is known about how to improve cancer screening, diagnosis and treatment in this high-risk population.
Methods:
We conducted interviews with state prison medical directors and primary care clinicians, and medical, radiation and gynecologic oncologists who coordinate or provide cancer care for individuals incarcerated in prison. Participants were recruited via 1) email invitation to participants at a correctional health conference, 2) purposeful sampling using targeted emails to clinicians in prison systems selected for diversity in size, geography and correctional health model (e.g., contracted care), and 3) snowball sampling of individuals from research and participant networks. Participants were interviewed about 1) logistics of cancer care delivery from screening and treatment through end-of-life care, 2) barriers and facilitators to cancer care delivery, and 3) evidence-based strategies to facilitate cancer care in prisons, including best practices. Interview transcripts were analyzed using mixed inductive/deductive thematic content analysis to identify emerging themes.
Results:
34 participants from 16 prison systems were interviewed (10 medical directors, 6 PCPs, 14 oncologists, 4 other). Participants reported prison clinicians coordinate most cancer care (e.g., screening, diagnosis and symptom management), while cancer treatment largely occurs in community or academic facilities outside of prison. Common barriers identified included underscreening / delays in diagnosis, complex logistical coordination, poor communication (between patients and oncologists, and prison clinicians and oncologists), inadequate symptom management, dehumanizing practices, loss-to-follow-up after release and that patients often come from marginalized populations. Common facilitators were better access to insurance, cancer screening, and general medical and cancer care than incarcerated patients might receive before/after incarceration. Participants identified multiple ways to improve cancer screening (creating enforceable standards, increasing continuing medical education, implementing electronic medical record reminders, reducing logistical barriers), cancer treatment (implementing navigators within prisons and cancer centers, prioritizing care with oncologist input, keeping care in prisons, decarceration), and transitions to the community (Medicaid activation prior to release, community partnerships to facilitate care transitions).
Conclusions:
Incarceration imposes multiple barriers to cancer care delivery, but clinicians identified numerous tools to improve cancer care in prison. Future studies should test and optimize these strategies to improve cancer outcomes for incarcerated patients.
Identifying and mitigating racial/ethnic disparities in clinical trials with screening data.
Authors: Hurley Patricia A. , Morgante Jim D. , Hanley Williams Jen Hanley , Guerra Carmen , Levit Laura A. , Ramos Natalie
Published: September 2024

63

Background:
ASCO and Association of Community Cancer Centers (ACCC) released a statement on increasing racial/ethnic equity, diversity, and inclusion (EDI) in cancer trials (1). It included recommendations for clinical practices and research sites to 1) screen every patient for trial eligibility; and 2) routinely collect and analyze screening and enrollment data by patient demographic characteristics, including race/ethnicity. Most of the 62 sites that completed a 2021 pilot study reported that screening data were not readily available by patient race/ethnicity (2). ASCO conducted a follow-up study about challenges, resource needs, and effective strategies for collecting and analyzing these data.
Methods:
Semi-structured interviews were conducted with research team members from sites that completed the 2021 pilot study. Sites were purposefully selected based on pilot study data quality and insights, diversity of patient population, and site type, size, and region. Sites completed a pre-interview questionnaire on site characteristics and screening and enrollment processes before participating in a 1-hour interview focused on challenges and effective strategies for collecting and analyzing screening and enrollment data, by race/ethnicity. Anticipated themes and relationships, stemming from the pilot study findings, informed a conceptual framework. Up to 20 interviews were planned and halted sooner when there was theme saturation.
Results:
Thirteen research sites participated in the study, representing academic centers (62%) and community-based practices/health systems (38%) with racially/ethnically diverse patient populations (median 31% non-white; range 11% to 63%). 53 research team members participated in the interviews (typically 4 per site), including investigators (23%), directors/managers (56%), and coordinators (21%). Aggregated responses were interpreted through content analysis and concepts were quantified for both frequency and extensiveness. Several barriers to patient screening, data collection, and analysis were cited, including lack of standardized procedures and documentation, dedicated staff and time, quality and/or accessible data on race/ethnicity and/or screening, and integrated technology that facilitates screening and documentation.
Conclusions:
Collecting and analyzing screening and enrollment data are critical to identifying and mitigating racial/ethnic disparities in trial access and EDI. Many sites do not systematically screen every patient for a trial and/or document outcomes. Lack of resources, including dedicated staff and time and integrated technology, make it difficult for them to do so in systematic and reliable ways. Greater investment in resources will help to facilitate routine screening of every patient and ensure underrepresented populations are not being overlooked for trials. 1.
Oyer et al, JCO, 2022
. 2.
Pressman et al, JCO, 2022
.
Health care contact days in older adults enrolled in SWOG cancer clinical trials.
Authors: Gupta Arjun , Till Cathee , Vaidya Riha , Hershman Dawn L. , Unger Joseph M.
Published: September 2024

64

Background:
Health care contact days—days with health care contact outside the home—are a measure of how much of a patient’s life is consumed by health care. This number of contact days are especially relevant for older adults with advanced cancer facing limited survival. One concern is that patients with different sociodemographic and clinical backgrounds may be at particular risk of increased contact days. Thus, there is a critical need to understand factors associated with contact days.
Methods:
We linked data from 6 SWOG trials in advanced cancer to Medicare claims data. These trials encompassed a variety of primary cancer types [prostate (S9916, S0421), lung (S0003, S0124, S0819), and pancreas (S0205)]. Health care contact days (days with ambulatory, emergency department, inpatient, or facility-based care) in the first 12 months were calculated using Medicare database files. A day with >1 source of contact counted as 1. We examined sociodemographic (age, race, ethnicity, sex, insurance status, rurality, area deprivation index) and clinical (prognostic risk, cancer type, performance status) predictors of contact days, using negative binomial regression, with a log link and clustering by study ID, including an offset variable for duration of observation. We examined predictors in univariate and multivariable analysis. We report relative risk (RRs) estimates and 95% CI.
Results:
We included 1,429 patients (median age, 71 years, 7.6% Black, 2.7% Hispanic, 21.4% female, and 23.5% rural residence). Of these, 741 (51.9%) patients died in the first year. The median number of contact days was 48, out of a median of 350 days of observation. At a trial level, median percentage of contact days ranged from 14% (prostate) to 27% (lung). The most common sources of contact days were ambulatory clinician visits (median=17), tests (median=12), and treatments (median=11). In multivariable regression, factors associated with increased contact days included increasing age (per year, RR=1.02 [1.01-1.02], p<.001), insurance status (Medicare alone or with Private or Medicaid insurance, vs Military/VA, none, or other insurance, RR=2.47 [2.16-2.83], p<.001), higher prognostic risk score (RR=1.14 [1.04-1.25], p=.004), and type of cancer (pancreas, RR=1.69 [1.51-1.89] and lung, RR=1.69 [1.54-1.85] vs prostate, p<.001 for both).
Conclusions:
This novel linkage of trial and claims data to evaluate contact days and associated factors found that older trial participants spent up to one in four days with health care contact. Ambulatory appointments were the most common source of contact days. Encouragingly, rural residence and neighborhood deprivation were not associated with contact days, increasing confidence that participants from diverse geographic areas may receive equitable care in trials. These data highlight the frequency of contact days for trial participants, while identifying factors to consider when benchmarking contact days.
Racial representation in multicenter clinical trials leading to drug approvals for gynecological cancer indications by the US Food and Drug Administration (FDA).
Authors: Ibanez Kristen R. , Khan Maheen , Donohue Duncan , Oluloro Ann , Swisher Elizabeth M. , Lee Jung-Min
Published: September 2024

66

Background:
Enrollment disparities in gynecologic (Gyn) cancer clinical trials in the United States (US) are well-documented. However, there is limited data evaluating how recruitment sites in international clinical trials contribute to racial representation, specifically in Gyn cancers. Here, we examined racial enrollment and geographic location in clinical trials that have led to approval for Gyn cancer applications.
Methods:
Agents approved by the FDA for Gyn cancer treatment and corresponding clinical trials were identified from the FDA Drug Approvals and Databases. Enrollment data were abstracted from ClinicalTrials.gov then cross-checked with published manuscripts and FDA labels. Using Gyn disease site prevalence from the 2021 SEER database, we calculated expected enrollment proportions by race and compared these to actual clinical trial enrollment data. The binomial test was used to compare expected vs. observed proportions with White patients as the reference group.
Results:
From 2014 to 2024, 9 drugs received 22 FDA approvals for ovarian (n=13), endometrial (n=4), or cervical cancer (n=5). These approvals were based on 28 clinical trials enrolling a total of 13,763 patients (75.7% White, 3.4% Black, 12.0% Asian, 8.9% Other/Unknown). These trials included 1 (3.6%) US only study, 3 (10.7%) non-US, primarily Europe-based studies (PAOLA-1, AURELIA, STUDY42 [Europe + Australia]), and 24 (85.7%) international studies across the US and 46 other countries. Considering the distribution of race (White: 86.3%, Black: 8.4%, Asian: 4.9%) of Gyn cancers in the US, Black patients had lower enrollment (45% of expected enrollment) vs. White patients (95% of expected enrollment, P<0.0001). African countries were rarely included among the recruitment sites. Two international trials reported patient recruitment from South Africa (3.2% Black, 6/188 patients, 38% of expected enrollment).However, Asian patients had higher enrollment (269% of expected enrollment, P<0.0001) compared to White patients. In 13 trials that included study sites in East Asia, Asian patients comprised 16% of the trial population (1310/8205 patients; 327% of expected enrollment) vs. 3.2% in trials that did not open in Asia (n=15) (181/5558 patients; 67% of expected enrollment).
Conclusions:
Black patients were underrepresented in pivotal trials that led to FDA approvals for Gyn cancers. Overrepresentation of Asian patients was likely due to international enrollment from East Asia. Post-marketing retrospective studies or additional studies focused on underrepresented groups are needed to assess true drug efficacy and safety in US populations that are disproportionately affected by Gyn cancer mortality.
Changes in adherence to cervical cancer screening guidelines before and after the COVID-19 pandemic in the United States.
Authors: Bilalaga Mariah Malak , Atarere Joseph , Gaddipati Greeshma Nihitha , Akhiwu Ted , Vasireddy Ramya , Mensah Boniface , Haas Christopher
Published: September 2024

73

Background:
The COVID-19 pandemic disrupted several aspects of routine healthcare delivery, many of which have yet to return to pre-pandemic levels of operation. In this study, we compared the adherence rates to cervical cancer screening guidelines in a nationally representative sample of American adults before and following the COVID-19 pandemic.
Methods:
We included female adults aged 21-65 who participated in the Health Information National Trends Survey (HINTS) 2019 and 2022. Adherence to cervical cancer screening was assessed based on the timing of their last Pap smear test. Participants were classified as non-adherent to cervical cancer guidelines if their last Pap smear test was more than three years ago. Survey-weighted Poisson regression models [adjusted for age, race, and education] were used to explore adherence ratios before and following the COVID-19 pandemic.
Results:
In 2019, among 1,944 female adults, representing a population of 93,477,003 adults, the mean age (standard deviation [SD]) was 44.5(12.6) years, 61.1% were non-Hispanic White, and 35.2% had a college education or higher. The prevalence of non-adherence to cervical cancer screening was 19.2% [95% CI: 16.3, 22.5]. In adjusted models, being non-Hispanic Black was associated with a lower risk of non-adherence (0.49 [95% CI: 0.30, 0.77] vs. non-Hispanic White), having lower education (less than high school vs. college graduate or higher) was associated with 2.28 [95% CI: 1.21, 4.31] higher likelihood of non-adherence to cervical cancer screening guidelines, while age was not (p>0.05). In 2022, the prevalence of non-adherence to cervical cancer screening was 25.8% [95% CI: 22.9, 29.1]. In adjusted models, having lower education was associated with 1.90 [95% CI: 1.22, 2.97] higher likelihood of non-adherence to cervical cancer screening guidelines, while age and race were not (p>0.05). Compared to 2019, non-adherence rates increased by 6.6% in 2022. When stratified by race, non-Hispanic White adults showed an increase of 5.6% [95% CI: 5.4, 5.6] in non-adherence rates, while non-Hispanic Black adults showed an increase of 13.9% [95% CI: 12.0, 15.2].
Conclusions:
There was a decline in adherence to cervical cancer screening guidelines among adult females in the US by about 7% following the COVID-19 pandemic. Additionally, non-Hispanic Black adults and those with lower education showed a disproportionately greater increase in non-adherence rates. These findings are relevant in advancing cervical cancer surveillance in the United States. Further studies are needed to elucidate barriers associated with greater non-adherence rates in minority groups following the pandemic and identify methods to provide more equitable access to healthcare services.
The cancer diagnostic clinic: A rapid access clinic to improve outcomes for patients with a suspected cancer diagnosis.
Authors: Ugarte Shannon , D'Avella Christopher , Gabriel Peter Edward , Ciunci Christine Agnes , Roy Megan , Schwartz Amy , Boyk Katie , Walker Suzanne , Tindall Jessica , Dougherty David W.
Published: September 2024

77

Background:
Patients with suspected cancer often face challenges navigating complex health systems, resulting in delays in diagnosis and time to treatment, which are associated with adverse outcomes and patient dissatisfaction. To improve patient access and bridge this healthcare gap, the Cancer Diagnostic (CDx) clinic was established to streamline the evaluation for patients with a new suspected cancer. The CDx clinic prioritizes expedited cancer evaluation, timely and accurate diagnostic testing, and transition of care to subspecialty Oncologists, to improve the patient experience and cancer-related outcomes.
Methods:
Leaders in the Abramson Cancer Center (ACC) initiated a pilot project to facilitate timely appointments to Oncologists for patients in the Emergency Department with a new suspected cancer. Patient access lead time and time to diagnosis and treatment were tracked. This pilot was formally expanded across the health system to become the CDx clinic for eligible adult patients with suspicious symptoms, lab abnormalities, or imaging findings concerning for cancer. Patient data was extracted using an EMR-based form and supplemented by chart review. Study period was March 2023 to April 2024 and included socio-demographics, cancer subtype, referral type, time from referral to new patient appointment (access lead time), time from first appointment to diagnosis and treatment (surgery, systemic or radiation therapy), patient retention, complications, and mortality.
Results:
Over 12 months, 108 patients were evaluated in the CDx clinic. Most patients were male (56%), White (58%), and non-residents of Philadelphia County (65%). There were 8 referrals (range: 6-13) per month with the majority of patients from external referrals (60.2%). Compared to baseline, CDx resulted (median pre/post in days) in similar time to first appointment (7 vs. 7 days), improved time to diagnosis (21 vs. 8 days), and improved time to treatment (42 vs. 29.5 days). 71 patients were diagnosed with cancer with Gastrointestinal (47%) and Thoracic (24%) cancers being most common. 98.6% (70/71) of patients were retained at ACC and transitioned to subspecialty care. 80.3% (57/71) of patients received cancer-directed treatment. After the initial consult date, for the patients diagnosed with cancer, there were 4 ED visits and 20 hospitalizations within 30 days, 19 hospice enrollments, and 16 deaths.
Conclusions:
The CDx clinic has been a valuable resource for patients with suspected cancer by optimizing time to diagnosis and time to treatment. Additional navigation pathways are underway to expand the CDx patient population to target a more underserved population in an effort to promote health equity in cancer care.
Molecular Subtypes Are Associated With Clinical Benefit in Cisplatin-Treated Metastatic Urothelial Cancer Patients
Authors: Holmsten Karin , Sjödahl Gottfrid , Abrahamsson Johan , Bernardo Carina , Eriksson Pontus , Höglund Mattias , Liedberg Fredrik , Ullén Anders
Published: September 2024

PURPOSE

Cisplatin-based combination chemotherapy (CHT) is standard of care in metastatic urothelial cancer (mUC); however, no predictive molecular biomarkers are available for clinical use. The aim of this study was to investigate the impact of molecular subtypes in relation to treatment response and survival in patients with mUC treated with first-line CHT.

PATIENTS AND METHODS

Molecular subtype classification according to the Lund Taxonomy (LundTax) was performed by tumor transcriptomic profiling and immunostaining in a retrospective cohort. Molecular subtypes were investigated in relation to the primary end point overall response rate (ORR) and secondary end points progression-free survival (PFS) and overall survival (OS). Differential gene expression and association to treatment response were explored.

RESULTS

Ninety-five patients with mUC were classified into urothelial-like (Uro, 43%), genomically unstable (GU, 26%), basal squamous-like (Ba/Sq, 20%), mesenchymal-like (Mes-like, 8%), and small cell neuroendocrine-like (Sc/NE, 3%) subtypes. Patients with Mes-like tumors had lower ORR (14%) compared with Uro (70%), GU (77%), Ba/Sq (75%), and Sc/NE (67%; odds ratio, 0.06 [95% CI, 0.01 to 0.54],
P
= .012). Furthermore, patients with Mes-like tumors had significantly shorter PFS (hazard ratio [HR], 5.18 [95% CI, 2.28 to 11.76],
P
< .001) and OS (HR, 3.19 [95% CI, 1.45 to 7.03],
P
= .004). Patients with Uro and GU showed the longest survival. In responders, an enrichment of downregulated stromal- and immune-related genes was seen. Downregulation of interferon-induced transmembrane protein 2 was associated with increased ORR and improved OS.

CONCLUSION

This study identifies different CHT responses by LundTax molecular subtypes in patients with mUC, where the Mes-like subtype was associated with lower response rate and shorter survival.
Inside the Black (W)hole: A Queer Black Feminist Retrospective
Authors: Roach Shoniqua
Published: September 2024

This essay introduces a spirited cross-disciplinary and intergenerational queer black feminist dialogue about what Evelynn Hammonds’s 1994 differences essay “Black (W)holes and the Geometry of Black Female Sexuality” has meant, and continues to mean, for queer black feminist knowledge production and (academic) subject formation within and beyond the United States. Across ten essays and one poem, contributors to this special issue of differences interrogate what it means for queer black feminists to labor in a field under constant erasure; to argue for the possibilities for queer and trans and sick black women’s erotic agency in the context of hostile institutional formations such as the academic and medical industrial complexes; and to analyze the relevance of empirical black holes for theorizing polymorphous black female sexualities and erotic freedoms. From inside the black (w)hole, contributors chart the history, present, and futurity of Hammonds’s “Black (W)holes,” and, by extension, the black diasporic feminist, lesbian, queer, and trans intellectual and sociopolitical life-worlds in its wake.
Is It Lonely (T)here? Intramurals, Black (W)holes, and Black Feminism
Authors: Finch Megan
Published: September 2024

This essay employs the autotheoretical critique of the university and celestial cartography pioneered in Evelynn Hammonds’s “Black (W)holes and the Geometry of Black Female Sexuality” to understand the dynamic relationship between the silencing of black academics and black women/feminists in various sites of the neoliberal university. Narrating two experiences at Ivy League institutions, this essay meditates on the voids created and inhabited when the gravity of black study’s insistence on blackness as essential to the construction of modernity collapsed into and under the name of Afropessimism. The essay interrogates how looking for the distortion of the academic spaces that surround and engage black thought—namely, American studies, ethnic studies, and women and gender studies—renders visible (presuming we have the right instruments) the production of black (w)holes. Finally, it is interested in how the black intramural’s gender dynamics and the heteropatriarchy of its surrounds continue to silence black feminists.
“Black (W)holes” and the Propagation of New Possibilities
Authors: Bailey Moya
Published: September 2024

The starting point of this essay is the author’s acknowledgment that Evelynn Hammonds’s “Black (W)holes and the Geometry of Black Female Sexuality” has been a throughline for her scholarly and personal development. That relationship to Hammonds’s text and its author shifts, and the changing nature of these connections marks important milestones in Bailey’s academic and adult life. The essay waxes poetic about the substance of Hammonds’s “Black (W)holes” as its meanings exceed its arguments: its very writing serves as a possibility model both in terms of the kind of scholarship Bailey imagined she could write and the kind of life she could live as one keen to bridge Black feminism and medicine. “Black (W)holes” is one of the first academic writings where Bailey saw herself reflected, both in the content presented and in the identities held by Hammonds. Black alphabet children of Spelman College, straddling the line between medical science and feminism, Hammonds and Bailey have much in common. Hammonds’s essay inspired Bailey to want to get to know the now legendary alumna, and this essay recounts how she embarked on a campaign to do so.
Is There a Stable Relationship between Unemployment and Future Inflation?
Authors: Fitzgerald Terry , Jones Callum , Kulish Mariano , Nicolini Juan Pablo
Published: September 2024

Evaluating the stability of the Phillips curve using aggregate data is challenging due to the bias that endogenous monetary policy imparts on estimated Phillips curve coefficients. We argue that regional data can be used to identify the structural relationship between unemployment and inflation. Our analysis, using city- and state-level data from 1977 to 2017, is consistent with the notion that both the reduced-form and the structural parameters of the Phillips curve are, to a substantial degree, quite stable. (JEL E12, E24, E31, E52, E58)
New Facts on Consumer Price Rigidity in the Euro Area
Authors: Gautier Erwan , Conflitti Cristina , Faber Riemer P. , Fabo Brian , Fadejeva Ludmila , Jouvanceau Valentin , Menz Jan-Oliver , Messner Teresa , Petroulas Pavlos , Roldan-Blanco Pau , Rumler Fabio , Santoro Sergio , Wieland Elisabeth , Zimmer Hélène
Published: September 2024

Using CPI microdata for 11 euro area countries over 2010–2019, we document new findings on consumer price rigidity in the euro area: (i) the average frequency of price changes is 12 percent; (ii) the distribution of price changes is highly dispersed, with frequent large and small changes; (iii) price changes are more frequent in January; and (iv) the overall size of price changes rises with inflation, but their frequency does not; these changes in the size are driven by movements in the fraction of price changes that are increases, not by the absolute size of price increases or decreases. (JEL E31, E52, F33, L11)
Accounting for the expansion of the universe using an energy/momentum model to construct the space-time metric
Authors: James Hugh
Published: September 2024

Background The success of the theories of special and general relativity in describing localised phenomena, such as objects undergoing high speed motion or located in gravitational fields, needs no further elaboration. However, when applied to the evolution of the universe several problems arise which can require an additional model, e.g., inflation during the early expansion, and adjustments to parameters to account for phenomena such as the late-time acceleration of the universe. Methods Focusing on the difference between the ways in which space and time are measured, this paper shows that there are two paths which allow the equations of special relativity to be produced from the same basic postulates. Results Both the standard theory and the energy/momentum, or dynamic model, utilise the Minkowski metric, but with different coordinate systems. The dynamic model transforms Cartesian coordinates into an Euclidean form by multiplying the coordinates by functions of γ (=(1–ν 2)c 2)-1⁄2). When utilising these coordinates, the relativistic equations are unchanged for local phenomena such as the Lorentz coordinate transformation and the energy/momentum equation for high-velocity objects. Conclusions However, the derived coordinates alter the perceived overall structure of the universe in a manner that, for the simplest model under this system, allows the reproduction of observed cosmological features, such as the intrinsic flatness of the universe and the apparent late-time acceleration of its expansion, without the need of additional models or changes in parameter values.
Game Over? Assessing the Impact of Gamification Discontinuation on Mobile Banking Behaviors
Authors: Blanchard Simon J. , Palazzolo Mike
Published: September 2024

Examines the removal of gamification from a financial services app and its impact on incentivized behaviors like bill payments.