bluuebunny/crossref_metadata_2025_split huggingface dataset:
Enhancing community capacity to improve cancer care delivery and the effect on patient-reported outcomes, healthcare utilization and total costs of care.
Authors: Patel Manali I. , Ramirez David , Agajanian Richy , Agajanian Hilda H. , Bhattacharya Jay , Coker Tumaini 
Published: May 2019

6522 Background: To curb rising expenditures and improve patient-reported outcomes (PROs), we designed an intervention with patient, caregiver, provider, and payer input. The intervention is based on prior work using a lay health worker (LHW) to assess advanced cancer patients' symptoms. In this study, we trained the LHW to refer patients to palliative care and/or behavioral health services in response to positive assessments and expanded the intervention to all cancer stages. We implemented the intervention with a health plan and a community oncology group serving elderly racially/ethnically diverse patients to test the effect on symptoms, healthcare use, and total costs. Methods: We enrolled all newly diagnosed health plan beneficiaries with solid and hematologic malignancies from 10/2016 to 11/2017 and compared outcomes to all cancer patients diagnosed in the year prior to the intervention (control arm). Our primary outcome was change in patient-reported symptoms using the Edmonton Symptom Assessment Scale and Personal Health Questionnaire-9 at baseline, 6 and 12 months post-enrollment. Secondarily, we compared 12 month healthcare use and costs. All generalized linear regression models were adjusted for age, stage, comorbidities, diagnosis, and follow-up. Results: 425 patients were in the intervention; 407 in the control. In both groups, mean age was 79 years; 48% were non-Hispanic White, 43% Hispanic, 3% Black, 6% Asian/Pacific Islander; 60% had advanced stages; 28% had breast, 28% had gastrointestinal, and 10% had thoracic cancers. Intervention patients had significantly decreased symptom burden over time as compared with the control (Mean Difference: intervention (-0.77 +/- 0.28 p = 0.01) vs. control: (0.45 +/- 0.25 p = 0.06)); difference in difference: (-0.68 +/- 0.25 p = 0.007)). Depression scores also significantly decreased over time among intervention patients as compared with the control (Mean Difference: intervention (-1.10 +/- 0.38 p = 0.04)) vs control: (1.21 +/- 0.34 p = 0.01); (difference in difference: -2.03 +/- 0.3 p < 0.001)). As compared to the control arm, intervention patients had lower inpatient admissions (0.7 vs. 0.5 p = 0.01) and emergency department visits per thousand patients per year (0.6 vs. 0.42 p = 0.02), and lower median total healthcare costs ($32,270 versus $25,512 p = 0.01). Conclusions: An LHW intervention significantly improved patient-reported outcomes and the value of cancer care delivery and may be a solution to improve burdensome and costly care for patients.
Association of providers’ prescribing patterns with postsurgical opioid use among cancer patients undergoing curative-intent surgery.
Authors: Xu Yuan , Cuthbert Colleen Ann , Karim Safiya , Kong Shiying , Dort Joseph C. , Quan May Lynn , Hinther Ashley V. , Cheung Winson Y. 
Published: May 2019

6530 Background: Patients with cancer are vulnerable to chronic opioid use. Although opioid use may be appropriate, preliminary data suggest that a significant proportion may be using opioids inappropriately. This study aims to evaluate the association between the history of the providers’ opioid-prescribing patterns and post-surgical opioid use in cancer patients undergoing curative-intent surgery. Methods: This population-based study included all patients diagnosed with common solid tumors who received curative-intent surgery and were non-opioid users prior to surgery between 2009 and 2015 in Alberta, Canada. Based on previously published methods, a new persistent opioid user was defined as opioid-naïve prior to surgery and who subsequently filled at least one opioid prescription between 60 and 180 days after surgery. The opioid-prescribing patterns of a patient’s most responsible provider (MRP) were measured as the mean daily dosage (oral morphine equivalent, OME) that was prescribed to all other patients by that provider prior to the surgical date. Multivariable logistic regression was performed to identify associations between the MRP’s prescribing patterns and the patient’s opioid use after surgery. Results: 14,780 patients met the inclusion criteria and were associated with 2,880 MRPs, among which 2,364 (16%) patients became new persistent opioid users after surgery. Multivariate analysis demonstrated that patients with MRPs who routinely prescribed higher doses of opioids (≥60 vs. 0-59 mg OME: OR = 2.33, P < 0.0001) for their patients were associated with a greater risk of new persistent opioid use after surgery. In addition, those with a higher Charlson comorbidity index (P = 0.006), visited more prescribers (P < 0.0001), had a specific tumor type (breast, colorectal, lung, prostate, melanoma or kidney vs. others, P < 0.0001), received adjuvant chemotherapy (OR = 1.37, P < 0.0001), and received adjuvant radiation (OR = 1.3, P = 0.0004) were also associated with greater risk of new persistent opioid use after surgery. Conclusions: Our results suggest that prescribers with a history of prescribing higher opioid doses are an important predictor of chronic opioid use among cancer patients undergoing curative-intent surgery. Awareness of physician prescribing practices and their unintended consequences may inform strategies to minimize persistent post-operative opioid use in cancer patients.
Evaluation of quality of life, satisfaction and cost of care in metastatic colorectal cancer patients receiving ambulatory chemotherapy.
Authors: Chansriwong Phichai , Sirilerttrakul Suwannee , Wannakansophon Nopakan , Tangteerakoon Patamaporn , Vongterapak Suluck , Jirajarus Manmana , Ckumdee Sineenuch , Sirachainan Ekaphop 
Published: May 2019

6536 Background: Colorectal cancer is an important health problems in Thailand; chemotherapy remains the most suitable treatment for metastatic patients. Chemotherapy treatment that was once delivered only in hospital environments is now administered at patient's home that helping patients to live normal lives during receiving chemotherapy. The chemotherapy regimens are based on a 48 hours 5-fluorouracil infusion combined that need patients to be hospitalized, consequence to decrease QOL and increase cost of treatment. Aims: Compares the QOL score, patients’ satisfaction and cost difference in treating ambulatory chemotherapy (AC) patients compared with inpatient treatment. Methods: An observational cohort which enrolled 156 patients at the Ramathibodi hospital from Dec 2015 to Nov 2016. AC administered by the central venous access device (CVAD). The regimen as FOLFOX or FOLFIRI, 5-FU were in the elastomeric infusion pump and administered at the patients’ home. Nurse coordinators followed up with the patients by phone. The FACT-G and FACT-C scale, patients’ satisfaction and cost of treatment questionnaire were collected at time of enrolment, 2 months and end of treatment. Results: 156 patients are enrolled that 111 patients treated with AC and 45 patients treated with inpatient. 134 returned the questionnaire (response rate 86%). Intention to treat analysis revealed significantly improved in social wellbeing and FACT-G (p <0.001) in AC group. Significant higher administration, service and overall satisfaction score in AC group. The AC reduced cost about 483 US dollars per cycle of chemotherapy. Conclusions: Ambulatory chemotherapy helps colorectal cancer patients to live normal lives by administer treatment at patients' home and results to significantly improve in quality of life especially in social wellbeing and more satisfaction. Moreover, ambulatory chemotherapy reduced cost of chemotherapy treatment.
Esophageal cancer in Hispanic patients: A demographic analysis of the National Cancer Database.
Authors: Ricardo Juan , Conte Jorge , Alkayali Talal , Salem Ahmed , Huston Jamie , Shridhar Ravi , Meredith Kenneth L 
Published: May 2019

6561 Background: Hispanics are the fastest-growing minority accounting for 18% of the US population. The National Cancer Institute estimated 17,290 new cases of esophageal cancer (EC) in the US in 2018. Hispanics are reported to have lower EC prevalence. We sought to interrogate the demographic patterns of EC in Hispanics. Secondary objective was to examine evidence of socioeconomic disparities and differential therapy. Methods: We queried the National Cancer Database to identify patients with EC between 2005–2015. Patients were divided into two groups, Hispanic vs Non-Hispanic (NH). Demographics compared were age, sex, tumor data, surgical intervention, type of treatment, insurance status, income, residence area, and Charlson/Deyo score. Pearson’s Chi-square test was used to compare categorical variables. Groups were matched by propensity score-matched analysis (PSM). Survival analysis was estimated by the Kaplan-Meier method and associated log-rank test. P-value ≤0.05 was considered significant. Results: We identified 85,004 patients with EC; 3,205 were Hispanic (3.8%). In this US population we identified significant disparities between the Hispanic and NH groups. Statistically significant differences among Hispanics included higher prevalence of squamous EC (24.7% vs 19.6%), higher likelihood of stage IV cancer diagnosis (40.7% vs. 34.8%), younger age, higher uninsured status (10.4% vs 3%) with income < $38,000 (26.4% vs 15.9%), and Charlson/Deyo score 0 (72.3% vs 70.7%) when compared to NH. However, Hispanics were less likely to have surgical intervention (29% vs 36.3) and overall less likely to receive any type of treatment (30.1% vs 26.1%). PSM showed that any treatment, insurance status and lower income were predictors of survival. Treated Hispanics survived longer than NH (median survival 17 vs 15 months). Overall survival at 5 years was 22% vs 17%, respectively, p < 0.05. Conclusions: Despite lower prevalence of EC in Hispanics compared to NH, there is a disproportionately higher number of metastatic and untreated cases among Hispanics. This disparity may be explained by Hispanics' limited access to medical care exacerbated by their socioeconomic and insurance status. Further clinical and epidemiologic research is warranted to reveal other factors impacting these health disparities.
Australian population-based study of single- versus multi-fraction palliative radiotherapy for bone metastases.
Authors: Ong Wee Loon , Foroudi Farshad , Millar Jeremy Laurence 
Published: May 2019

6568 Background: Single fraction palliative radiotherapy (SFRT) has been shown to be equivalent to multi-fraction radiotherapy (MFRT) for bone metastases symptom management. Remuneration for radiotherapy (RT) in Australia are largely determined by fractions delivered. We aim to determine the use of SFRT for bone metastases in Australia. Methods: We did a population-based linkage study of multiple administrative healthcare databases in Victoria, Australia: the Victorian Radiotherapy Minimum Data Set (VRMDS), the Victorian Cancer Registry (VCR), and the Birth, Death and Marriage registry (BDM). All patients with solid tumour (excluding primary bone cancer) who received palliative radiotherapy for bone metastases between 2012 and 2017 were included. The primary outcome was use of SFRT. The Cochrane-Armitage test for trend was used to evaluate SFRT use over time. Multivariable logistic regression was used to identify factors associated with SFRT use. Results: A total of 15,668 courses of RT for bone metastases were delivered to 10,351 patients. The overall proportion of SFRT was 18% (2,746/ 15,668). There was no significant change in SFRT use over time, from 18% in 2012 to 20% in 2017 (P = 0.06). Older patients were more likely to have SFRT (mean age 69.4 vs. 68.2, P < 0.001). Patients who had lung cancer (21%) and prostate cancer (19%) were more likely to have SFRT compared to other tumour types (P < 0.001). Spine RT was associated with lower use of SFRT compared to other treatment sites (14% vs. 22%, P < 0.001). Patients from remote area were more likely to have SFRT compared to patients from major cities (22% vs. 17%, P < 0.001). Patients treated in private institutions were less likely to have SFRT compared to those treated in public institutions (10% vs. 22%, P < 0.001). In multivariate analyses, patients’ age, tumour type, area of residence, and treatment institutions were independently associated with SFRT use. Conclusions: This is the largest Australian population-based cohort treated with RT for bone metastases, with low utilisation of SFRT over time. There is large variation in SFRT use depending on patient-, tumour-, geographical and institutional factors. Further work is needed to increase uptake, and reduce unwarranted variation, in SFRT use.
A novel patient-centric approach between sites, CRO, and sponsor to accelerate FPI and drive more patients into oncology protocols.
Authors: Kowalczyk Krystyna , Henry Rhonda U. , Conte Bellinda 
Published: May 2019

6573 Background: According to the Journal of Clinical Oncology, 50% of sites performing clinical trials never enroll a patient. And on top of that, it can take several months to activate a site for an oncology clinical trial; precious time that patients cannot afford when they’ve had a cancer diagnosis and precious time sponsors need when developing new compounds for market. While many patients are interested in participating in trials, they are limited in their opportunities because they do not live near a research site or work with a physician performing clinical trials. So with this crisis in the oncology field, research needs to be more efficient and inclusive. Methods: A combined partnership of sites, physicians, CRO and sponsor leveraging Just-in-Time enrollment methodology helped expedite clinical trial enrollment and diversify trial access driving faster first patient enrolled and expanding the potential patient denominator. Results: This on-demand methodology augmented existing sites that had access to oncology patients by providing broader access, faster, and with no quality loss. Strong partnerships between CRO and sponsor then facilitated two-week site activation allowing every identified patient to be converted to a study subject. This methodology was repeated across seven protocols driving patents on trials within six weeks of trial available. Conclusions: The benefits of this Just-in-Time methodology touch all areas of clinical trials: Patients have greater clinical trial access: A larger denominator of patients across broader geographies have local access to portfolios of clinical trials; Trials start to enroll faster: Patients can be randomized into oncology clinical trials within two weeks of study start up driving trial time to completion; Sites have more trial options to consider: Sites have a broader portfolio of trials to access on demand without added administrative burden; Trials complete faster: Sponsors accrue patients faster driving expedited timelines and accelerating drug development.
Reporting of patient reported outcome (PRO) in clinical trials: A systematic review of clinical trials.
Authors: Vidal-Fisher Liat , Vidal Boixader Laura , Andrianov Vasily , Curtis Kelly Kevelin , Shepshelovich Daniel , Moss Keren Rachel 
Published: May 2019

6590 Background: Clinically relevant outcomes as improvements in overall survival (OS) or quality of life (QOL) should guide decision-making. The FDA encourages the implementation of patient-centric measures in clinical trials. Over the past decade a growing number of protocols have included PROs in their outcome measures. We aimed to evaluate the frequency at which PRO measures, incorporated into clinical trials, are made publicly available, when trial results are published. Methods: We searched Citeline Trialtrove database, a registry of clinical trials, for randomized phase 3 trials of patients with non-small cell lung cancer (NSCLC), recruiting during 2006-2016, with PRO listed. We excluded trials evaluating supportive treatment, and those unpublished. We identified publications associated with the trial, and extracted various parameters, including whether or not PRO outcome was published. Results: Of 158 NSCLC trials identified, 99 listed at least 1 PRO. 24 trials were excluded (supportive care, unpublished). The commonly used scales were EORTC-QLQ C30, QLQ-LC13, LCSS, FACT-L, and EQ-5D. Study sponsor was industry in 45 trials, and industry-academic in 12 trials. Of 75 trials analyzed, 41 (55%) published the results of the PRO endpoint. Only 37% of the 75 included a comprehensive report of PRO, and many publications referenced the PRO briefly. Of 41 trials that reported PRO, only 21 (51%) provided information about missing PRO data. 59 trials were published as full-text, of which 40 (68%) reported the PRO, and 53% reported the PRO more than 6 months after the initial full publication. Of the trials that showed PFS benefit, with no OS benefit, 22/34 (65%) published the results of the PRO endpoints. Conclusions: Despite a growing emphasis on QOL and the inclusion of PROs in oncology clinical trials, and despite patient and healthcare provider efforts to record PRO data, a significant number of NSCLC randomized trials do not report the PRO. The collection of PRO data should result in routine, timely and appropriate reporting as part of the trial outcome publication, to allow for a thorough assessment of investigational clinically relevant treatment effect.
Clinical utility and reimbursement for expanded genomic panel testing in adult oncology.
Authors: Hsiao Susan Jean , Sireci Anthony , Pendrick Danielle , Freeman Christopher , Yang Jessica , Schwartz Gary K. , Mansukhani Mahesh M. , Carvajal Richard D. , Oberg Jennifer A. 
Published: May 2019

6593 Background: The routine use of large next generation sequencing (NGS) cancer panels is required to identify the increasing number of, but often uncommon actionable alterations present across multiple tumor histologies to guide therapy. Inconsistent coverage and variable payment is hindering adoption of these tests into clinical practice. A review of clinical utility, coverage and reimbursement was conducted in a cohort of adult oncology patients who received expanded genomic panel testing as part of their clinical care. Methods: The Columbia Combined Cancer Panel (CCCP), a 467 gene panel designed to detect single nucleotide variants, indels, and copy number variations in solid and liquid tumors was performed in a CLIA-certified laboratory at Columbia University Irving Medical Center. Clinical utility categories included: immediate change in management; informed future treatment options; provided diagnostic/prognostic information; and other impact. Claims were submitted between 1/1/17 and 4/30/18. Carriers were categorized into commercial, managed-government, and government plans. Results: 300 tumors underwent NGS. Reimbursement data were available for 258 cases. 57% of testing was performed for a treatment-resistant, recurrent, or high stage cancer, or for a cancer of rare/mixed histology (21%). Findings were clinically actionable in 183 cases (61%). Results led to an immediate change in management (n = 6, 2%), informed future treatment options (n = 140, 47%), and provided diagnostic/prognostic information (n = 29, 10%). Only 57 tests (22%) received coverage. In 59% of denials (118/201), a clinically-actionable result was found. Commercial plans reimbursed 29/119 tests (24%) and managed-government plans reimbursed 28/54 tests (52%). Government plans provided no coverage for 85 tests. On average, insurers reimbursed 10% of the total CCCP service charges: 12.5% for commercial and 22% for managed-government plans. Conclusions: Expanded genomic testing identified clinically-impactful alterations in 61% of cases. Limited coverage and low reimbursement remain a barrier and broader reimbursement policies are needed to adopt expanded genomic testing that benefits patients into clinical practice.
Quality of life (QOL) in patients undergoing CAR-T therapy versus stem cell transplant (SCT).
Authors: Sidana Surbhi , Dueck Amylou C. , Burtis Michelle , Griffin Joan M. , Thanarajasingam Gita , Warsame Rahma M. , Thompson Carrie A. , Cheville Andrea L. , Gertz Morie A. , Yost Kathleen J. , Dispenzieri Angela , Villasboas Bisneto Jose , Paludo Jonas , Ansell Stephen M. , Rajkumar S. Vincent , Bennani Nabila Nora , Johnston Patrick B. , Siddiqui Mustaqeem Ahmad , Lin Yi , Kumar Shaji 
Published: May 2019

6594 Background: Given the significant short-term adverse effects of CAR-T cell therapy, it is important to evaluate its impact on QOL of patients in addition to efficacy, compared with established forms of cellular therapy like SCT. Methods: QOL was evaluated prospectively in patients undergoing CAR-T therapy, autoSCT & alloSCT for hematologic malignancies. QOL was assessed with FACT-G at baseline, 2 weeks and monthly for 6 months thereafter. Functional well-being (FWB), physical WB (PWB) emotional WB (EWB) & social WB (SWB) and change over time were compared across groups. Results: 45 patients were recruited (CAR-T: 10; Auto SCT: 22; Allo SCT: 13) with follow up for 2 weeks & 1 month available for 23 &15 patients, respectively (Table). There was no statistically significant difference in baseline total QOL scores (p=0.13), though scores were lower in the alloSCT group (85,84,68). EWB &FWB were numerically higher in the CAR-T group, followed by autoSCT group. At 2 weeks, overall QOL decreased by only 2 points in CAR-T group vs. 22 & 18 points in auto & alloSCT groups (p=0.09). Change in PWB vs. baseline was less pronounced in the CAR-T group (-1, -9, -13, p=0.03). At 1 month, overall QOL was 6 points lower than baseline in CAR-T group vs. 3 and 14 points lower in auto & alloSCT groups, respectively (p=0.34). Importantly, PWB had at least returned to baseline in the CAR-T group. Conclusions: Preliminary data show that patients undergoing CAR-T cell therapy do not experience a more significant decline in QOL compared with auto & allo SCT, and may experience fewer physical side effects in the short-term. Accrual & follow-up are ongoing. [Table: see text]