bluuebunny/crossref_metadata_2025_split huggingface dataset:
5-year multicenter analysis of clinical trial participation and total cost of care for older adults with cancer.
Authors: Subbiah Ishwaria M. , Indurlal Puneeth , Alam Naiyar , Ives Hope , Staggs Stuart George , Wilfong Lalan S. 
Published: June 2024

11013 Background: Clinical trial access particularly for older adults aged 65 years and above with cancer is impacted by multilevel barriers, including cost concerns to payers in the usual models of cancer care delivery. Alternative models recently studied include the Centers for Medicare and Medicaid Innovation’s Oncology Care Model (OCM), a value-based care pilot to enhance quality & reduce costs. Here, we investigated the association between clinical trial participation (CTP) and the total cost of care (TCOC) within this non-traditional model. Methods: We identified prospective longitudinal observational cohort of patients cared for in 11 states within 323 clinics in 14 multi-site community practices participating in OCM, in The US Oncology Network and extracted data (episode claims, medical records, episodes) from OCM performance periods (PP) 3-11 between 7/1/17 and 6/30/22. Propensity score matching by PP, age, gender, date of death, cancer type identified the analysis cohort of matched episodes, then stratified by trial participation (CTP vs usual care) to compare TCOC and drug expenditures. Results: Over 5 years, 121,717 unique patients (94% of whom were aged 65y+) received 282,604 episodes of cancer care in the community, most common cancers being breast, lung, multiple myeloma. Propensity score matching identified 13,260 matched episodes (6630 usual care, 6630 CTP). The actual expenditure differed by $2,341 per episode between CTP & usual care (CTP $43,890 vs usual care $41,548; p < 0.0001), while trial participation had significant savings against the OCM CTP benchmark ($4816 saved per CTP episode), compared to usual care vs its benchmark ($826 saved per usual care episode, p < 0.0001). Drug costs per episode did not differ between the two groups (CTP $29,516 vs usual care $30,553; p 0.54). Further breakdown shows that drug spending on anticancer agents (CTP $28,008 vs usual care $29,139) and other drugs including supportive care meds (CTP $1,511 vs usual care $1,414) did not differ significantly. Conclusions: Clinical trial participation saw relative cost savings against the benchmark compared to usual care, owing largely to the higher benchmark prices for CTP episodes in OCM’s risk-adjusted price prediction model, rather than an absolute cost savings to payers. Drug expenditures remain the largest contributor to total cost of care in this alternative model. The contributors to both drug expenditures as well as the absence of absolute cost savings between the two cohorts represent key areas for further investigation. CMMI Disclaimer: The statements contained in this document are solely those of the authors and do not necessarily reflect the views or policies of CMS. The authors assume responsibility for the accuracy and completeness of the information contained in this document.
Evaluation of the study of control arms in randomized clinical trials of cancer.
Authors: Jain Sandeep Kumar , Zauderer Marjorie Glass , Sethi Tarsheen , Schoen Martin W. , Rubinstein Sam , Nguyen Ryan Huu-Tuan , Nagpal Seema , Mohan Sanjay , Madireddy Sathwik , Lythgoe Mark , Liang Wayne , Kulkarni Amit , Kothari Shalin , Hilal Talal , Hadfield Matthew James , Goyal Gaurav , Ganta Teja , Dholaria Bhagirathbhai R. , Brown Alaina J. , Warner Jeremy Lyle 
Published: June 2024

11023 Background: Randomized clinical trials (RCTs) in cancer typically compare experimental to control arm regimens. The choice of an appropriate control (ctrl) arm can have a major impact on the expected success of an RCT. The frequency with which cancer RCTs use control arms based on established dosing and scheduling protocols has not been described. Methods: The HemOnc knowledgebase (KB) was used to identify systemic anti-cancer therapy (SACT) regimen variants, defined as regimens with identical components that differ in dosing, scheduling, and/or route. Non-cancer, nonrandomized, and non-SACT studies were excluded. Study publication year was used to define standard variants as those evaluated in the experimental arm of a positive phase 3 RCT >1 year prior to publication as a control arm, regardless of cancer type or context of treatment. Study-variant dyads were evaluated to determine whether the variant was standard. Success rates of RCTs with standard vs non-standard control arms were evaluated with Fisher’s exact test. Results: 5221 studies were associated with ≥1 named variant in the HemOnc KB, as of 2024-02-06. After exclusions, there were 3511 study-variant dyads (2386 studies; 1714 variants). The 9 most common regimens are shown in the Table. The median (IQR) number of variants per regimen was 2 (1-3); carboplatin & paclitaxel (CP) had the most variants (n=33). Across all control arm study-variant dyads, 2228/3492 (64%) utilized non-standard variants. For example, 60/97 studies (62%) of docetaxel as control used the 75 mg/m2 q3wk variant after it was established in 2000, whereas n=27 others used 19 non-standard variants. Trials that used a standard control arm had a numerically higher success rate, 45% vs 42% (OR 1.10, 95% CI 0.92-1.32). Conclusions: Non-standard regimen variants are frequently used in cancer RCTs. Reasons for this could include toxicity, patient convenience, or emerging data from smaller studies that establish comparable efficacy or improved toxicity to standard variants. However, the a priori efficacy of non-standard control arms is less rigorously established, and trials with standard control arms might be more successful. Future directions include quantifying the granular differences between standard and non-standard variants and investigating whether certain types of non-standard variation (e.g. fewer cycles, lower doses) associate with trial success rates. [Table: see text]
Examining the financial landscape of cancer: An analysis of debt and bankruptcy among patients in Massachusetts (2010-2019).
Authors: Uppal Nishant , Gomez-Mayorga Jorge , Fleishman Aaron , O’Donoghue Ashley L. , Bogdanovski Anastasia , Esselen Katharine , James Benjamin 
Published: June 2024

11032 Background: Financial toxicity is commonly reported by patients following a cancer diagnosis. Prior patient surveys indicate that up to one-third of cancer patients incur medical debt, of which 55% carry balances exceeding $10,000. In addition to debt and bankruptcy, credit scores are an important indicator of socioeconomic well-being following cancer diagnosis, because they affect housing stability, transportation access, and may even be predictive of health. Limited studies quantify incurred debt, bankruptcy rates, or credit scores following a cancer diagnosis compared with patients without a cancer diagnosis. Methods: Individuals with a cancer diagnosis in Massachusetts from 2010 to 2019 were identified through the Massachusetts Cancer Registry, and patient-level records on debt, bankruptcy, and other measures of financial well-being were linked using data from a major United States credit bureau. Changes in medical debt, credit score and bankruptcy filings were evaluated over time and compared with a random sampling of individuals residing in Massachusetts over the same time period that did not have a cancer diagnosis and were matched based on demographic factors. Results: 99,175 individuals with cancer and 188,875 individuals without cancer were identified, and average annual total debt balances were $758 and $669, respectively, throughout the study period. The highest total debt balances were observed among individuals with thyroid cancer ($913). Average annual medical collection balances were $45 for individuals without cancer and $52 among those with cancer with the highest balances among those with liver cancer ($66). Across the study period, the average annual bankruptcy incidence rate per 100 persons was 7.15 for those without cancer and 6.22 among those with cancer, with the highest incidence rates among those with thyroid cancer (7.34). Although there was a gradual increase in credit score in the control population, survivors of bladder, liver, ovarian, colorectal and lung cancers experienced a decline in credit scores. Conclusions: High rates of financial toxicity among individuals with cancer suggest that widespread healthcare and consumer finance reforms have not yet fully alleviated medical debt and bankruptcy in Massachusetts. Further research is needed to understand drivers of financial burden over time among those with cancer.
Development and validation of point-of-care mobile solution to guide the diagnosis of malnutrition: A multicenter, prospective cohort study.
Authors: Zhou Xueyan , Lin Nan , Ma Xuelei 
Published: June 2024

11042 Background: Malnutrition has negative effects on patients with chronic diseases, leading to reduced treatment tolerance, increased risk of clinical complications, and even death. This research was aimed to develop a point-of-care program based on facial features to screen malnourished inpatient patients. Methods: In this prospective, multicenter, cohort study, we retrieved facial photograph and malnutrition screening scales from 4 different hospitals. We utilized a variety of machine learning models to explore whether the ocular area could serve as an enhanced region for facial recognition nutrition. Last, we utilized a facial area segmentation and weighted approach to retain the information of full-face features using a BP neural network and validated using Delong-test, IDI-test, and NRI-test. Overall, 619 inpatients’ facial photographs and their corresponding nutrition screening questionnaires were used to train, validate and test the machine learning model. Results: The Pearson correlation analysis showed a significant correlation (p<0.05) between the two questionnaires in all groups. The average AUC obtained from the five-fold cross-validation set was 0.886 (CI 0.843-0.930), 0.834 (CI 0.764-0.904), and 0.927 (CI 0.899-0.955) for the Cancer Inpatient Group, Other Inpatient Group, and All Inpatient Group, respectively, with the corresponding AUC obtained from the external validation set being 0.860 (CI 0.817-0.904), 0.843 (CI 0.796-0.889), and 0.887 (CI 0.829-0.944). Conclusions: The facial photograph-based point of-care mobile solution can screen malnutrition with good accuracy, showing its potential for screening malnutrition in inpatients in the hospital in different types of diseases.
Association of cancer survivors’ experience of care with financial toxicity: Results from a national survey.
Authors: Halpern Michael T. , Knowles Reegan Kate , Thamm Carla , Chan Raymond J 
Published: June 2024

11099 Background: Financial Toxicity (FT), negative economic impacts resulting from cancer or cancer treatment, can adversely affect quality of life, treatment adherence, and clinical outcomes. Patient experience of care (EoC) captures information from patient’s perspectives on interactions with healthcare providers and systems and receipt of medical care services. While EoC is used to evaluate health care system and provider quality, the impacts of EoC on FT are unknown. Methods: To examine associations of EoC and FT, we used data from the from the 2016-2017 Experience of Cancer Survivorship Supplement of the Medical Expenditure Panel Survey (MEPS), the most recent years available of this national U.S. household survey. EoC was assessed using patient-reported frequencies (rated “never/sometimes”, “usually”, or “always”) of their health professionals explaining things in a way that was easy to understand; listening carefully; showing respect; and spending enough time with the patient in the past 12 months. FT was based on 9 MEPS items and classified as material FT (borrowing money, making financial sacrifices due to cancer), psychologic FT (worry about paying medical bills or financial stability), and behavioral FT (delaying/forgoing cancer care due to costs). Analyses were performed using multivariable logistic regressions controlling for patient sociodemographic and clinical characteristics and weighted to produce nationally representative estimates and address survey non-response. Results: Data included 1068 individuals diagnosed with cancer at age 18 or older; 30% reported material FT, 35% psychologic FT, and 27% behavioral FT. Examining EoC, 64% of respondents indicated their health professionals always explained things; 60% that they always listened; 66% that they always showed respect; and 57% that they always spent enough time with the patient. In multivariable regressions, the odds of psychologic FT were significantly (p<0.05) lower among patients reporting their health professionals always (vs. never/sometimes) listened (odds ratio [OR] 0.37, 95% CI 0.19-0.70), showed respect (OR 0.36, 95% CI 0.16-0.81), and spent enough time with the patient (OR 0.47, 95% CI 0.26-0.86). Significant associations with EoC were also found with individual psychologic FT questions from the MEPS on worry about paying bills, financial stability, and keeping job/income. Conclusions: Worry/anxiety regarding costs can be a major factor affecting individuals with cancer. Improving patient-provider interactions to enhance patient EoC may help reduce this aspect of FT.
Viral hepatitis screening in patients with early breast cancer receiving cancer therapy: A quality improvement initiative.
Authors: Klein Katherine , Hwang Jessica Park , Valero Vicente , Ramirez David Luis , Kaushik Jaime 
Published: June 2024

11125 Background: ASCO guidelines recommend screening all patients for hepatitis B virus (HBV) before initiation of cancer therapy. Comprehensive screening for HBV includes measuring HBV surface antigen (HBsAg), HBV core antibody (anti-HBc), and antibody to HBV surface antigen (anti-HBs). ASCO also recommends hepatitis C virus (HCV) screening in patients with cancer. Cancer patients receiving cancer therapy represent a vulnerable population and reactivation of undetected hepatitis virus can lead to devastating consequences such as liver failure and death. At MD Anderson Cancer Center, rates of hepatitis screening for all cancer patients has been historically low. For example, rates are around 29% for HBV screening in patients receiving cancer therapy in 2019-2021. The aim of this quality improvement study is to increase rates of HBV and HCV screening in early breast cancer patients in the Breast Medical Oncology clinic at MD Anderson before undergoing cancer therapy to at least 50%. Methods: Quality improvement measures were implemented by 1) creation of an order panel in the electronic medical record (EMR) which contains all tests needed for comprehensive HBV and HCV screening (HBsAg, anti-HBc, HBsAb, and anti-HCV), and 2) an educational session to providers in the Breast Medical Oncology clinics. Data was collected for patients seen at MD Anderson initiating cancer therapy (start of cycle 1) between April 1, 2023 until September 30th, 2023. Inclusion criteria were early breast cancer patients (Stage I-III) and receiving chemotherapy at MD Anderson. Exclusion criteria were Stage IV disease, or those receiving chemotherapy at an outside institution. Results: A total of 340 patients were screened, and 219 were determined to meet inclusion criteria for data extraction. In total, 105 patients (48%) received comprehensive HBV screening, with 137 (63%) receiving at least one HBV test. A total of 122 (56%) patients were screened for HCV. Combining data for both HBV and HCV, 88 (40%) received both comprehensive HBV and HCV screening (HBsAg, anti-HBc, anti-HBs, anti-HCV). A majority of patients (91% for HBV and 93% for HCV) were screened prior to cycle 1 of cancer therapy. The EMR order panel was utilized in 51 (23%) of patients. Anti-HBc was positive in 8 of those tested, and HBsAg was positive in 1 patient. No patients tested positive for HCV. Conclusions: Screening rates for HBV and HCV individually were near or exceeded our goal, however rates of combined HBV and HCV screening were lower. Going forward, additional education to providers as well as increased awareness of the available order panel will be needed to ensure we are comprehensively screening for both HBV and HCV in our patients. [Table: see text]
Commercial health plan spending on oncology drugs approved via the accelerated approval pathway and later withdrawn from the market.
Authors: Patel Tejas , Curran Eamonn , Hellems Sarah S 
Published: June 2024

11134 Background: The U.S. Food and Drug Administration (FDA) introduced the Accelerated Approval Program in 1992 to expedite the approval of drugs that can be used to treat certain conditions and fill an unmet medical need. Clinical trials conducted to achieve accelerated approval status often use surrogate outcomes as primary endpoints to reduce the time it takes to get FDA approval. Drug manufacturers must conduct further research to verify and report the projected clinical benefit and safety. The FDA may issue traditional approval to previously accelerated approved drug or may request the manufacturer to withdraw a drug from the market based on the clinical benefit and/or safety demonstrated in the confirmatory trial(s). We report members impacted, total drug claims, and total drug cost incurred by a commercial health plan associated with the coverage of oncology drugs approved by the FDA and later withdrawn from the market between 2020 to 2023. Methods: Fifteen unique indications associated with oncology drugs that received accelerated approval and later withdrawn by the FDA were identified between 2020 to 2023. A cohort of patients enrolled in commercial health plan was further identified using the ICD-10 code related to the drug indication being withdrawn. To calculate total paid amount for drugs, de-identified administrative claims data submitted on behalf of this cohort were sorted and summed in this time period using either J-code for drugs covered under medical benefits or national drug code (NDC) for drugs covered under pharmacy benefits. Results: Between 2020 to 2023, 8 oncology drugs were withdrawn because of later failing to demonstrate clinical benefit in the confirmatory trials, 2 drugs were withdrawn due to safety concerns, and 5 drugs were withdrawn due to drug manufacturer unable to complete a confirmatory trial. In this population, we identified 18,430 unique members with 103,743 administrative claims. The total paid amount was $1,392,553,995 in this time period. The average drug cost per administrative claim was $13,423 and the average drug cost per member was $75,559. Conclusions: Drug costs established by manufacturers are not differentiated based on the approval status - accelerated or regular. While drugs approved via accelerated approval pathway may provide benefit to certain patient population, the cost associated with accelerated approved drugs needs more attention. Indication-specific pricing model may help alleviate the cost burden associated with drugs approved via accelerated approval pathway. [Table: see text]
Inpatient healthcare utilization in the first year following a childhood cancer diagnosis: A population-based analysis.
Authors: Ohlsen Timothy James Daeeun , Doody David , Noyd David H , Desai Arti D , Leisenring Wendy M. , Mueller Beth A , Chow Eric Jessen 
Published: June 2024

11138 Background: Children with cancer may require substantial healthcare resources during treatment, including inpatient care. Hospital utilization patterns at the population level, and factors associated with higher utilization, are not well-described. Methods: We conducted a retrospective cohort analysis of Washington State (WA) cancer registry data (1992-2013) linked to state birth (1974-2013), death (1992-2013), and hospital discharge (1992-2013) records to identify all WA children diagnosed with cancer <20 years. We examined hospitalization frequency and total inpatient bed days in the year after cancer diagnosis. To evaluate factors associated with outcomes of interest, we constructed multivariable negative binomial regression models of children with ≥1 inpatient admission, calculating incidence rate ratios (IRR). Covariates included rural residence (binary; census tract rural-urban commuting area codes), high neighborhood deprivation (binary; state-normative census block group Area Deprivation Index [ADI]), sex, race/ethnicity, diagnosis age, birth year, and cancer type (per International Classification of Childhood Cancer). Due to differences in utilization by cancer type, we also examined children in subanalyses with acute lymphoblastic leukemia (ALL), lymphomas, and solid (including central nervous system [CNS]) tumors. Results: 2,231 children (mean diagnosis age 7.2 years; 68% diagnosed since 2000) had 12,833 inpatient encounters. In the year after diagnosis, children had a median of 4 (IQR 2-8) hospitalizations/year at-risk, and 21 (IQR 8-54) inpatient days (median length of stay 4 days [IQR 2-6]). In multivariable analysis, high ADI (IRR 1.11, 95% CI 1.01-1.21), but not rural residence (IRR 0.95, 95% CI 0.85-1.05), was associated with greater hospitalization frequency. Female sex was associated with lower frequency (IRR 0.94, 95% CI 0.88-1.00). In analysis of total inpatient days, high ADI (IRR 1.15, 95% CI 1.02-1.29) and Hispanic ethnicity (IRR 1.31, 95% CI 1.13-1.51) were independently associated with greater inpatient days. In subanalysis of patients with ALL (N=497), associations between inpatient days and ADI (IRR 1.18, 95% CI 0.99-1.40) and Hispanic ethnicity (IRR 1.01, 0.84-1.23) were no longer significant. For lymphoma (N=259), associations were similar but also no longer significant (ADI IRR 1.14, 95% CI 0.78-1.71; Hispanic IRR 1.26, 95% CI 0.79-2.10). Among patients with solid/CNS tumors (N=1,151), associations with Hispanic ethnicity remained significant (IRR 1.46, 95% CI 1.19-1.80), but not ADI (IRR 1.11, 95% CI 0.95-1.30). Conclusions: Children with cancer spend considerable time inpatient during the year after diagnosis. Disparities in hospital utilization mirror some known disparities in childhood cancer survival. Initiatives to alleviate systemic disadvantages may reduce inpatient utilization for some groups.