bluuebunny/crossref_metadata_2025_split huggingface dataset:
U.S. trends and racial/ethnic disparities in opioid access among patients with poor prognosis cancer at the end of life (EOL).
Authors: Enzinger Andrea Catherine , Ghosh Kaushik , Keating Nancy Lynn , Cutler David M , Landrum Mary Beth , Wright Alexi A. 
Published: May 2020

7005 Background: Heightened US opioid regulations may limit advanced cancer patients’ access to effective pain management, particularly for racial/ethnic minority and other vulnerable populations. We examined trends in opioid access, disparities in access, and pain-related emergency department (ED) visits among cancer patients near end of life (EOL). Methods: Using a 20% random sample of Medicare FFS beneficiaries, we identified 243,124 patients with poor prognosis cancers who died between 2007-2016. We examined trends in outpatient opioid prescription fills and pain-related ED visits near EOL (30 days prior to death or hospice enrollment), for the overall cohort and by race (white, black, other). Per-capita opioid supply by state was obtained from the federal Drug Enforcement Agency ARCOS database. Geographic fixed-effects models examined predictors of opioid use near EOL, opioid dose in morphine milligram equivalents (MMEs), and pain-related ED visits, adjusted for patient demographic and clinical characteristics, state, opioid supply, and year. Results: From 2007-2016 the proportion of patients with poor prognosis cancers filling an opioid prescription near EOL fell from 41.7% to 35.7%, with greater decrements among blacks (39.3% to 29.8%) than whites (42.2% to 36.5%) and other races (38.2% to 32.4%). The proportion of patients receiving long-acting opioids near EOL fell from 17% to 12% overall (15% to 9% among blacks). Among patients receiving EOL opioids, the median daily dose fell from 40MMEs (IQR 16.5-98.0) to 30MMEs (IQR 15.0–78.8). In adjusted analyses, blacks were less likely than whites to receive EOL opioids (AOR 0.85; 95% CI, 0.80 to 0.91) and on average received 10MMEs less per day (b -9.9; 95% CI -15.7 to -4.2). Patients of other race were also less likely to receive EOL opioids (AOR 0.92; 95% CI, 0.85-0.95), although their dose did not differ significantly from whites. Rates of pain-related ED visits near EOL increased from 13.2% to 18.8% over the study period. In adjusted analyses, blacks were more likely than whites to have pain-related ED visits (AOR 1.29, 95% CI, 1.16-1.37) near death, as were those of other races (AOR 1.30; 95% CI, 1.17-1.37). Conclusions: While lawmakers have sought to mitigate the impact of opioid regulations upon cancer patients, access to EOL opioids have decreased substantially over time with concomitant increases in pain-related ED visits. There are significant racial/ethnic disparities in opioid access, with blacks receiving fewer opioids at lower doses and having more ED-based care for pain near EOL.
Reassessing the net health benefit (NHB) of FDA approved cancer drugs with evolution of evidence using the American Society of Clinical Oncology Value Framework (ASCO-VF).
Authors: Delos Santos Seanthel , Witzke Noah , Arciero Vanessa Sarah , Rahmadian Amanda Putri , Everest Louis , Chan Kelvin K. 
Published: May 2020

7011 Background: Regulatory approval of oncology drugs are often based on data presented in the primary publication of clinical trials (CT). However, clinically relevant data, such as long-term overall survival (OS) and quality of life (QOL), are often reported in subsequent publications. Therefore, this study aimed to evaluate the ASCO-VF NHB at the time of drug approval and over time as further evidence is published. Methods: All FDA approved oncology drug indications from 01/06-12/16 were reviewed to identify CTs that were scorable using the ASCO-VF version 2. Subsequent publications of included CTs relevant for scoring were identified from Web of Science with a follow-up time of 3 years from approval. Using ASCO-defined threshold scores of ≤40 for low benefit and ≥45 for substantial benefit, changes in classification of benefit were assessed at 3-years post-FDA approval. Results: We identified 57 FDA approved indications (40.4% OS, 59.6% progression-free survival (PFS) as primary endpoints) with scorable ASCO-VF CTs. Among those 57 indications, 36.8% at the time of FDA approval demonstrated substantial benefit, 10.5% demonstrated intermediate benefit, and 52.6% demonstrated low benefit. We then identified 96 subsequent publications relevant to scoring within 3-years of FDA approval, consisting of primary endpoint updates (29.2%; 14.6% OS, 12.5% PFS), secondary endpoint updates (44.8%; 16.7% OS, 7.3% PFS), new reporting of secondary endpoint (4.2% OS), safety updates (28.1%), and QOL reporting (43.8%). Upon reassessment of the NHB in subsequent publications, there was an overall change from initial classification of benefit in 36.8% of trials (17.5% became substantial, 8.8% became low, and 10.5% became intermediate). Changes in scores were mainly the result of an updated hazard ratio (35.1%), change in scoring endpoints from PFS to OS as per ASCO-VF endpoint hierarchy (8.8%), toxicity updates (57.9%), new tail of the curve bonus (12.3%), palliation bonus (14.0%), or QOL bonus (22.8%). Overall, at reassessment at 3 years post-FDA approval, 42.1% were substantial, 10.5% were intermediate, and 47.3% were low benefit. Conclusions: Only a modest proportion of FDA approved drugs have demonstrated substantial NHB at time of approval. As further evidence was published, a substantial proportion of indications have a change in classification of NHB, resulting in a small increase in the overall proportion of indications being deemed to have substantial benefit at 3 years post-approval.
Impact of utilization management policy on uptake of hypofractionated radiation in early-stage breast cancer.
Authors: Chi Winnie , Parikh Ravi Bharat , Fishman Ezra , Zimmerman Robert Paul , Gupta Atul , Barron John , Sylwestrzak Gosia , Bekelman Justin E. 
Published: May 2020

7015 Background: While hypofractionated radiation (HFR) after breast-conserving surgery is a cost-effective, patient-centered treatment in early-stage breast cancer (ESBC), less than 40% of eligible women received it in 2013. In 2016, a large commercial payer implemented a utilization management policy to encourage HFR for eligible women through denying reimbursement for extended-course radiation. We assessed the impact of the policy on HFR use and associated spending. Methods: We conducted a retrospective, adjusted difference-in-differences analysis using administrative claims of women continuously enrolled in 14 geographically diverse commercial health plans covering 6.9% of US adult women. The study population included women aged 18 or older with ESBC who were eligible for HFR according to 2011 guidelines from the American Society for Radiation Oncology. Women who received mastectomy, brachytherapy, or < 11 or > 40 external beam fractions were excluded. We compared HFR use and associated spending between women in fully-insured and Medicare Advantage (fully-insured) plans for whom the policy applied vs. self-insured or Medicare supplemental insurance (self-insured) plans for whom the policy did not apply. We adjusted for age, comorbidity, region, Medicare enrollment, and prior chemotherapy. Results: Among 10,540 eligible women, 3,619 (34%) were in fully insured plans and thus subject to the policy. There were no meaningful differences in mean age (63.8 vs. 65.0), Charlson comorbidity index (3.0 vs. 3.2), or practice setting between the fully-insured and self-insured groups. The policy was associated with an increase in HFR (4.2 adjusted percentage point difference-in-difference [ppd], 95% CI 0.0 to 8.4, p = 0.051) and a non-significant decrease in radiotherapy-associated expenditures (-$2,275, p = 0.09). Spillover analyses revealed significantly higher uptake of HFR among self-insured patients who were indirectly exposed to the policy through seeing the providers who also treated fulled insured women (8.5 adjusted ppd, 95% CI 3.6 to 13.5, p = 0.001), compared to those who were not exposed. Conclusions: A payer’s utilization management policy was associated with direct and spillover increases in HFR use, even after accounting for a strong secular trend towards increased hypofractionation use. However, policymakers must balance the impact of this and similar policies against their additional administrative costs.
Composite grading algorithm for National Cancer Institute’s PRO-CTCAE.
Authors: Dueck Amylou C. , Becker Claus C. , Rogak Lauren J. , Schrag Deborah , Reeve Bryce , Spears Patricia , Smith Mary Lou , Gounder Mrinal M. , Mahoney Michelle R. , Schwartz Gary K. , Bennett Antonia Vickery , Mendoza Tito R. , Cleeland Charles S. , Sloan Jeff A. , Bruner Deborah , Schwab Gisela , Atkinson Thomas Michael , Thanarajasingam Gita , Bertagnolli Monica M. , Basch Ethan M. 
Published: May 2020

7018 Background: Standard reporting of symptomatic adverse events (AEs) in oncology relies on clinicians to rate patient (pt) experience using CTCAE; each symptom is represented by a single graded item. To capture direct pt experience, NCI developed PRO-CTCAE to supplement CTCAE. In PRO-CTCAE, the pt answers up to 3 questions per AE about a symptom’s frequency, severity and interference with daily activities. To align PRO-CTCAE with CTCAE, we developed an algorithm for mapping sets of questions for an AE to a single composite numerical grade. Methods: We used a 5-step process. (1) All 187 possible PRO-CTCAE score permutations were presented to clinical investigators to subjectively map permutations to single numerical grades (range 0-3). (2) Permutations with < 75% agreement were presented to investigator committees at a National Clinical Trials Network meeting to gain majority consensus via anonymous voting. (3) The resulting algorithm was refined via graphical and tabular approaches to assure directional consistency. (4) Validity, reliability and sensitivity were assessed in a national study dataset. (5) Accuracy for delineating AEs between study arms was measured in 2 phase III clinical trials (Alliance for Clinical Trials in Oncology A091105 and Exelixis COMET-2). Results: (1) 12/187 score permutations had < 75% initial agreement. (2) Majority consensus was reached for all permutations. (3) 5 mappings were adjusted to assure directional consistency. (4) Composite grades for 46/59 (78%) AEs were higher in pts with ECOG performance status 2-4 vs 0-1 (median effect size 0.23 [range -0.49-0.73]; 32/59 effect size ≥0.2; 25/59 p< 0.05), similar to when conducting analysis on individual unmapped items. The test-retest reliability for 24 selected composite grades ranged from 0.57-0.96 (median intraclass correlation coefficient [ICC] 0.77) with 18/24 (75%) grades having ICC ≥0.7. Median (range) standardized response means in pts reporting worsening, no change, and improvement were 0.20 (0.03-0.34), -0.06 (-0.20-0.03) and -0.12 (-0.32-0.06). (5) Pattern, directionality and statistical significance of between-arm differences in both trials were preserved with composite grades as compared to individual unmapped items. Conclusions: A composite grading algorithm for PRO-CTCAE was rigorously developed and validated. PRO-CTCAE composite grades may be useful in analyses to provide a single metric for each pt-reported AE for trial and real-world reporting. Support: UG1CA189823; U01CA233046; HHSN261200800043C; Bayer (A091105); https://acknowledgments.alliancefound.org .
Predictive survival ability of patient-reported in comparison to physician-reported performance status in solid malignancies.
Authors: Al-Rashdan Abdulla , Sutradhar Rinku , Nezari-Rad Narges , Yao Cindy , Barbera Lisa Catherine 
Published: May 2020

7019 Background: Performance status (PS) is an important prognostic tool in cancer management that is mainly generated by physicians. In oncology, the Eastern Cooperative Oncology Group (ECOG) measure is commonly used. Patient-reported functional status (PRFS) is an emerging method that allows patients to provide an estimate of their function; however, there is limited information about its prognostic significance in solid tumors. We explored the prognostic value of PRFS in comparison to ECOG on survival. Methods: 13,045 newly diagnosed cancer patients in Ontario, Canada, who had information from both PRFS and ECOG on the same day of an outpatient visit between March 2013 and March 2018 were included. The dataset were randomly divided into 60% training (n = 7,827) and 40% validation (n = 5,218) cohorts. Covariates were similar at baseline for both training and validation datasets. Survival was estimated by modeling clinical characteristics with PRFS, with ECOG, and alone. Results: PRFS and ECOG scores were statistically significant predictors of overall survival. Both higher PRFS and ECOG scores tended to be associated with inferior survival, hazard ratio (HR) = 1.71 (P < .0001), and HR = 1.90 (P < .0001) respectively. Models that included either PRFS or ECOG scores outperformed the model with baseline clinical characteristics only. C statistics were 0.836, 0.839, and 0.811 respectively. Conclusions: Patient-reported functional status adds to survival modeling and is equally predictive as the ECOG scale at various stages of solid malignancies. PRFS may be used instead of ECOG in clinical or research setting for survival estimation.
Videos improve patient understanding of misunderstood chemotherapy terms in a rural population.
Authors: Abernethy Eli Rowe , Campbell Gavin Paul , Hianik Rachel , Thomson Mary Catherine , Dixon Margie D , Switchenko Jeffrey M. , Pentz Rebecca D. 
Published: May 2020

7022 Background: Rural communities can have low health literacy, which impacts the adequacy of informed consent, adherence to treatment, and outcomes. We had previously created and tested educational videos about basic chemotherapy terminology for use in an underserved population at our inner-city hospital. This study aimed to determine if these videos increased understanding of these terms in rural communities. Methods: Through patient and provider interviews in an underserved urban setting, 20 basic cancer treatment terms were identified as frequently misunderstood. As a pilot, 6 of these terms were explained in short, animated one-minute videos using VideoScribe (Sparkol).To determine if these videos improved understanding in the rural setting, 50 rural patients, specified as patients living in a county ranked 4-9 on the USDA Rural Urban Continuum Code (RUCC) scale, were asked to define each term before and after viewing the video. All answers were audiotaped and double coded for correctness of definition pre and post video screening, using the video definition as the correct definition. Before video and after video correct definition rates were calculated, along with 95% exact binomial confidence intervals using the Clopper-Pearson method. The videos for all 20 terms can be viewed on CancerQuest ( https://www.cancerquest.org/media-center/videos/cancer-treatment-terms ). Results: Participants were mostly white (79%), female (52%), resided in the more rural counties RUCC ranked 6-9 (62%), had < a high school degree (56%) and had a family income of <$40K (59%). Conclusions: Improving health literacy is a critical component in improving care. Our study establishes that a simple and easily disseminated intervention can significantly increase patient understanding of basic chemotherapy terminology in a rural setting. [Table: see text]
Impact of the affordable care act and early Medicaid expansion on head and neck cancer mortality in the United States.
Authors: Osazuwa-Peters Nosayaba , Barnes Justin M , Pannu Jaibir S , Simpson Matthew C , Challapalli Sai D , Rohde Rebecca L , Adjei Boakye Eric 
Published: May 2020

7035 Background: Medicaid expansion has been associated with increased access to care and earlier stage at diagnosis among patients with head and neck cancer (HNC). However, it is unclear whether Medicaid expansion has impacted HNC mortality rates. We examined the associations between early Medicaid expansions (2010-2011) with mortality rates for HNC in the United States. Methods: Data were obtained from the Surveillance, Epidemiology, and End Results (SEER) program. SEER*Stat was utilized to obtain mortality rates for early expansion (CA, CT, DC, MN, NJ, and WA) and non-early expansion states (all others) in the year ranges as available in SEER: 2005-2007 (pre-expansion) and 2012-2016 (post-expansion). Deaths in 2008-2011 were excluded as a phase-in/washout period. Difference-in-differences analyses were utilized to compare mortality rates pre- and post-early expansion in early expansion vs. non-early expansion states. The parallel trends assumption was tested comparing changes in HNC mortality rates between early expansion and non-early expansion states from 2002-2004 to 2005-2007 and from 2005-2007 to 2008-2011. Results: There were 6882 and 35459 deaths due to HNC in early expansion and non-early expansion states, respectively. HNC mortality rates (deaths per 100,000) decreased from 2005-2007 to 2012-2016 in both early expansion (2.17 to 1.85, difference = -0.32, 95% CI = -0.42 to -0.22) and non-expansion states (2.59 to 2.43, difference = -0.16, 95% CI = -0.22 to -0.11). Relative to non-expansion states, there was a reduction of 0.16 deaths per 100,000 (95% CI = 0.05 to 0.27, p = 0.007) after early Medicaid expansion in expansion states. However, in parallel trends testing, there was no difference in the change in mortality rates between early expansion and non-expansion states from 2002-2011 (p > 0.37). Conclusions: In this quasi-experimental analysis, there was an association between early Medicaid expansion with decreased HNC mortality. Thus, Medicaid expansion might help decrease disparities associated with access to care among HNC survivors. As longer-term data emerges, additional follow-up will be necessary to understand the mechanisms that underlie the HNC mortality benefits seen in early Medicaid expansion.
Patient-reported health literacy and numeracy among new patients seeking consultation at a comprehensive cancer center.
Authors: McCleary Nadine Jackson , Cleveland Jessica , Zhang Sunyi , Lepisto Eva M. , Lee Sherry , Hassett Michael J. , Schrag Deborah 
Published: May 2020

7038 Background: Health literacy and numeracy are essential for patients to make informed cancer treatment decisions. Oncologists do not typically evaluate literacy and numeracy and vary in their ability to adapt health discussions to meet patients’ needs. Systematic ascertainment of literacy and numeracy may provide oncologists with useful information to help guide initial oncology consultations. Methods: We deploy an electronic new patient intake questionnaire (NPIQ) that includes health literacy and numeracy, basic demographics and cancer risk screening. Patients are considered to have limited health literacy and/or numeracy if they respond with either “somewhat”, “a little bit” or “not at all” to a single question: “How confident are you filling out medical forms?” or “How confident are you in understanding medical statistics?” respectively. Results: Between January 2018 and August 2019, 8418 (24.6%) of patients presenting for a new patient consultation responded to the NPIQ. Among respondents with non-missing data, limited health literacy was reported by 19.4% respondents with 13.9% reporting “not at all” and 33.1% reporting “not at all” or only “a little bit” of confidence completing medical forms. Limited health numeracy was reported by 33.2% respondents with 9.1% reporting “not at all”. Nearly 20% of respondents reported both limited health literacy and numeracy. Patients reporting lack of confidence completing medical forms or understanding medical statistics were older (20.3%, 30.7% ³ 70 years old), male (20.2%, 30.1%), and non-white (21.3%, 32.1%). Conclusions: A substantial proportion of cancer patients report lack of confidence in their ability to complete medical forms or understand medical statistics, potentially limiting the ability to actively engage in shared decision-making. Prospective identification of these social determinants of health prior to consultations may provide oncologists with information necessary to tailor health discussions and to provide materials that promote understanding and informed decision-making. [Table: see text]
NSCLC: Integrating the “Yale model shared decision-making solution” into the practice setting.
Authors: Adelson Kerin B. , Herbst Roy S. , Peterson Patricia , Ingram Michele , Oliver Brant J. , Agrawal Tarjani , Davies Marianne , Rudell Elaine 
Published: May 2020

7054 Background: Lung cancer patients are faced with treatment choices that involve complex decisions that can be preference-sensitive. In 2017 the National Quality Forum initiated a “Call to Action” to integrate shared decision-making (SDM) processes into practice in which clinicians and patients work together to make healthcare decisions that align with what matters most to patients. Projects In Knowledge, @Point of Care, Dartmouth and Yale collaborated to develop a pilot educational initiative to address and improve patient-centered care and SDM processes in the institutional cancer-care setting. Methods: Training materials co-developed for the Yale NSCLC team members (oncologists, nurses/NPs, social worker) address SDM, Checkpoint Inhibitor Therapy in NSCLC, and clinician-patient role play methods for implementing SDM in treatment discussions/decisions. Qualitative interview and observational methods were used to assess improved SDM performance by the multidisciplinary Yale NSCLC team by comparing baseline pre-intervention to post-intervention interviews and rating observed performance on case study role-play scenarios. Following the training and assessments, a focus group that included all team members was conducted to assess the acceptability, feasibility, and repeatability of the program and to inform future education. Results: Training empowered all Yale NSCLC team members to show pre- to post-education improvement in SDM (34% to 88%). Areas of greatest improvement: 1) providing reasonable treatment options to patients (+58%); 2) determining decision style preference – to what extent a patient wants to participate in the treatment decision process with their clinician (+76%); 3) determining patients’ risk tolerance regarding treatments that may be more efficacious but may have more side effects (+77); and 4) determining patients’ goals/preferences (+88%). Conclusions: Educational training improved SDM skills by all Yale NSCLC team members, which can lead to improved clinician-patient decision-making and patient-centric care. The training process also facilitated team building and encouraged ongoing participation in SDM.