bluuebunny/crossref_metadata_2025_split huggingface dataset:
Caveat medicus: Harrowing experiences of clinicians who identify and publish near-fatal oncology associated adverse drug reactions.
Authors: Godwin Ashley Caitlin , Bennett Charles L. 
Published: May 2019

6584 Background: Less than 1-10% of adverse drug reactions are reported. It is even more rare to find clinicians who choose to publish these reports in the literature. We identified clinicians who had treated a patient for an oncology-associated serious adverse drug reaction and published these findings. This is the first study that has investigated personal experiences of clinicians choosing to publish information about serious oncology-associated drug reactions they see in their patients. Methods: Clinicians treating individual patients who developed oncology-associated serious adverse drug events were asked to participate. Inclusion criteria included having index patient information, reporting case series, and being collaborative with investigators from two National Institutes of Health funded pharmacovigilance networks. Thirty-minute interviews addressed feedback from pharmaceutical manufacturers, FDA personnel, and academic leadership, and recommendations for improving pharmacovigilance. Responses were analyzed using constant comparative methods of qualitative analysis. Results: 18 clinicians met inclusion criteria and 14 interviewees are included. Toxicities included central nervous system infections, arterial/venous thromboembolism, gastrointestinal toxicity, cardiac arrhythmias, and cancer development/progression. These investigations were frequently followed by label warnings and/or convening of Food and Drug Administration (FDA) Advisory Committee reviews of safety findings. Five studies were disseminated in four high-impact factor medical journals (JAMA, Lancet, Annals of Internal Medicine, and New England Journal of Medicine). Six clinicians received feedback characterized as supportive from academic leaders, while four clinicians received feedback characterized as negative. Responses from pharmaceutical manufacturers were characterized as negative by 12 clinicians. Responses from FDA employees were characterized as negative by six clinicians. Three clinicians recommended that pharmacovigilance should include simplified clinician reporting systems. Conclusions: Our study finds that clinicians who published reports of serious oncology-associated drug reactions experienced negative feedback from pharmaceutical manufacturers. Feedback from FDA employees and academic clinicians were viewed as supportive by some and negative by others. Most clinicians recommended that future pharmacovigilance involve big data analyses.
Real-world effectiveness of approved anticancer agents among Medicare beneficiaries.
Authors: Green Angela , Curry Michael A. , Bach Peter , Mailankody Sham 
Published: May 2019

6589 Background: The overall survival (OS) among elderly patients (pts) treated with novel anticancer agents in the real world may be inferior to the OS reported in pivotal trials for drug approval. Pts ≥ 65 yrs old constitute 60% of cancer pts, yet only 40% of cancer clinical trial participants. Elderly pts have greater comorbidities and experience a higher risk of toxicity from cancer drugs. Using the Surveillance Epidemiology and End Results-Medicare database (SEER-Medicare), we compared the OS among elderly pts treated with FDA-approved cancer drugs for advanced solid tumors to the OS reported in the clinical trial. Methods: We identified cancer drugs FDA-approved for metastatic solid tumors between 1/1/08-12/31/12. In a retrospective analysis, for each indication we identified pts in SEER-Medicare meeting disease eligibility criteria (stage, histology, prior therapies) in the trial associated with approval. Pts were diagnosed with cancer from 2010-2013 with follow-up through 2014. Treatment (tx) was determined from national drug codes in Medicare Part B for intravenous (IV) drugs and Part D for oral drugs. Indications were included if ≥ 30 pts receiving tx met eligibility. Kaplan-Meier methods were used to calculate median OS and cancer-specific survival (CSS) in Medicare pts. Median duration of therapy (DOT) was estimated from date of the first through completion of the last prescription claim for oral drugs and number of cycles for IV drugs. Results: OS data were available and sample size parameters met for 14 drug indications. The median OS among SEER-Medicare pts was shorter than the reported trial OS of tx arms for 13 of 14 drug indications (median difference -7.6 mos, range +3.4 to -28.7 mos). CSS was similar to OS among Medicare pts. Median DOT among SEER-Medicare pts was shorter than the reported trial DOT of tx arms for 13 of 14 indications (median difference -2.9 mos, range 0 to -8.9 mos). Conclusions: The OS and DOT among SEER-Medicare pts treated with FDA-approved cancer drugs was inferior to the reported OS in pivotal clinical trials for nearly all indications analyzed. The shorter DOT among Medicare pts may explain survival differences. Trials leading to regulatory approval may not be generalizable to cancer pts ≥ 65 yrs.
A living systematic review of immune checkpoint inhibitors in cancer patients: A novel platform for evidence synthesis in oncology.
Authors: Riaz Irbaz Bin , Siddiqi Rabbia , Malik Saad , Cathcart-Rake Elizabeth Jane , Gajic Ognjen , Montori Victor , Wang Zhen , Herasevich Vitaly , Go Ronald S. , Rajkumar S. Vincent , Murad M. Hassan 
Published: May 2019

6596 Background: Several previous systematic reviews and meta-analyses have attempted to summarize toxicity of Immune checkpoint inhibitors (ICIs). However, very soon after each one of these reviews has been published, it became outdated. ICIs are currently used in 14 different cancers and data is rapidly evolving from new clinical trials. A living Systematic review, which is defined as a systematic review that is continually updated to incorporate relevant new evidence as it becomes available, is necessary in this situations. Therefore, we performed an updated systematic review and a meta-analysis which will serve as a foundation of a living Systematic review. Methods: MEDLINE, EMBASE and Cochrane were searched to identify phase 2 and 3 RCTs of PD-1/PD-L1 ICIs. Included studies compared either immunotherapy alone or combination with existing standard of care treatment and reported data for AE’s of interest. DerSimonian-Laird random effects Meta-Analysis was performed to derive pooled odds Ratio (OR) estimates for AE’s of interest. An infrastructure of a living systematic review is being developed and it includes monthly literature searches, cumulative meta-analysis and an online reporting platform. Results: We screened 6746 studies and 31 phase 3 and 2 phase 2 RCTs (n = 21,421) were included in the analysis. 22 RCTs used PD-1/PD-L1 ICIs as a single agent and 11 as a combination therapy. Selected toxicity estimates are summarized in a table. Conclusions: The meta-analysis updates previously published toxicity estimates and provides additional information about the risk of toxicities in single versus combination regimens. We have initiated the first living systematic review in oncology that will be continuously updated, incorporating relevant new evidence as it becomes available, and will provide accurate and up to date toxicity estimates to support clinical decision making. [Table: see text]
Where’s my doctor? the impact of the primary oncologist’s visit with their hospitalized patients.
Authors: Bakow Brianna R. , Schiffman Fred , Mega Anthony E. 
Published: May 2019

6603 Background: Continuity of care is a cornerstone of the patient-practitioner relationship and patient satisfaction. The inpatient continuity visit (ICV), a face-to-face patient-provider interaction, involves a discussion regarding hospital course and care goals and decisions. We theorize that the ICV influences patient satisfaction. Previously, patient satisfaction has been related to patient perception of physician conduct, including communication skills. Currently, there are no studies investigating the impact of an ICV on inpatient oncology patients on a hospitalist service. Objectives: To assess the relationship between the ICV and patient satisfaction. We hypothesized that one or more visits by the outpatient oncologist would enhance satisfaction of oncology inpatients. Methods: Subjects (N=82) were comprised of adult inpatients on the oncology unit at Miriam Hospital, a teaching hospital of the Alpert Medical School of Brown University. All participants had an oncologist at the hospital based cancer center. A survey, given at discharge, included a 5-point Likert scale ranging from greatly worsened to greatly improved to assess the impact of the ICV on patient satisfaction. Results: Of 82 participants, 46 reported a visit by their outpatient oncologist. Forty-two (91.3%) reported that this visit either greatly or somewhat improved satisfaction with their hospital stay, while 8.7% reported no impact. Of patients whose oncologist visited once, 94.4% reported either greatly or somewhat improved satisfaction compared to 89.3% who had more than one visit. Out of 36 subjects who did not receive a visit, 16.7% reported that the lack of visit either greatly or somewhat worsened their hospital stay, while 83.3% reported no impact. Conclusions: Our study suggests that an ICV improves satisfaction of care in cancer patients on a hospitalist service. Furthermore, one of every six subjects who did not receive an ICV reported a negative impact on satisfaction. Results highlight a possible intervention to the discontinuity of care that may be perceived by patients. While the practicality of this intervention requires evaluation, the efficacy of a single continuity visit to improve satisfaction is reassuring.
Multi-institution quality improvement in supportive oncology: Results of the Coleman Supportive Oncology Collaborative (CSOC).
Authors: Khosla Paramjeet , Trosman Julia Rachel , Roggenkamp Betty , Lillis Teresa , Martin Joanna , Lo Shelly S. , Pasquinelli Mary , Knightly Eileen , Bowman Anne , Chow Selina Lai-ming , Patel Urjeet , Berardi Rosa , Diaz Aidnag , Kircher Sheetal Mehta , Weldon Christine B. 
Published: May 2019

6606 Background: The Institute of Medicine and Commission on Cancer recommend systematic delivery of supportive oncology care for cancer patients. The CSOC is focused on quality improvement (QI) of supportive care across Chicago cancer centers (Weldon ASCO ’17). Supportive oncology includes distress, practical, family, physical, nutrition, pain, fatigue and care concerns. To support QI, cross-institution teams developed unique, relevant tools, methods, care delivery processes, patient handouts and online training. Methods: Ten centers (5 academic, 1 VA, 1 public, 2 safety net, 1 community) implemented supportive oncology screening and care delivery quality improvements. Centers collected data for relevant Quality Oncology Practice Initiative (QOPI) metrics. Analyses used simple frequencies and Fishers exact test. Results: Five of six QOPI measures were improved at statistically significant levels from 2014 to 2017, p < .00001. Improvements are more modest in 2016 & 2017 as 4 of the centers started this QI in 2017. Conclusions: The CSOC achieved significant improvements in supportive oncology screening and identifying and addressing patients’ needs and concerns. Additional work is needed to improve these measures to achieve the best quality of cancer care possible for every patient based on their needs and concerns. [Table: see text]
Utilization of value stream mapping to improve chimeric antigen receptor (CAR) T-cell patient experience at an academic medical center (AMC).
Authors: Porter Julie , Kong Katherine A. , Latchford Theresa , Bergman Debbie , Doran Sonni , Fajardo Nimfa , Goldstein Gary , Rodin Melissa , Segura Smith Andrea , Spiegel Jay Y. , Miklos David Bernard 
Published: May 2019

6607 Background: Value Stream Mapping (VSM) is commonly used to identify waste, reduce process cycle times and implement process improvements in the product and manufacturing space. VSM was applied to analyze and improve the patient experience for individuals receiving CAR T cell therapy at this AMC, with emphasis on safety and quality of care, efficient patient flow and improved communication across the care team. Methods: Fifty-three multidisciplinary representatives from 21 teams across the AMC participated in at least one of the five 4-hour VSM sessions. Comprehensive VSM workflows were created for each step in the current CAR T cell patient journey, from initial referral through post-infusion care. Future state analysis was performed, with emphasis on identification of information technology improvements, communication and pain points. Baseline outcome metrics were established to assess effectiveness of future state VSM improvements. Results: Visual mapping of the CAR T cell patient journey identified several opportunities for improvement. A total of 72 improvement projects were outlined, which could be grouped into four main categories: (1) establish channels for improved care team communication, (2) build information technology infrastructure to support efficient patient flow and quality of care, (3) develop teaching tools for patient and care team education, and (4) delineate standard of care and clinical trials operational workflows. Baseline outcome metrics were measured across the patient population (n = 33), including time from consent to cell collection, length of inpatient stay, intensive care unit (ICU) utilization, and percent of readmissions within 7 days. Outcome metrics will be tracked and reported after future state changes to determine effectiveness of VSM-based process improvements. Conclusions: CAR T cell therapy is a novel therapy, which poses new challenges for coordination across a multidisciplinary care team at an AMC. The VSM approach is a useful tool to identify process and infrastructure improvements that can improve the patient journey. This approach can be generally applied to drive process improvements across clinical care.
Characterization of oncologic patient visits at the emergency department (ED) at an Austrian tertiary care center.
Authors: Minichsdorfer Christoph , Pauzenberger Bettina , Laggner Anton , Zielinski Christoph , Fuereder Thorsten 
Published: May 2019

6609 Background: Oncologic patients frequently seek out the ED as first contact point. Besides the rare classic oncologic emergencies other causes are supposed to be more frequent. However, little is known about reasons of patients with active malignancies to consult the ED. Methods: Retrospective data regarding emergency visits of patients with a medical history of active cancer or adjuvant therapy, who were taken by ambulance to the ED in the time period from 01.01.2017 – 31.07.2017, was collected. For OS Kaplan-Meier curves were created and univariate COX proportional hazards model analysis was used and log rank tests were performed. For statistical analysis the chi2-test was used to investigate significant relations between the three months mortality (3MM) and patient characteristics. 3MM was defined as death within 3 month of the first ED consultation. Results: From a total of 1029 patient contacts 743 met the inclusion criteria. In total 552 patients were included. The median age was 67 years (Minimum: 18y; Maximum: 95y). The vast majority of patients (480, 87%) were in a palliative setting. 243 patients (44%) were under active treatment. The biggest group of patients suffered from lung cancer (18%) followed by hematologic malignancies (14%), pancreaticobiliary tumours (11%), breast cancer (8%) and colorectal cancer (7%). In total 111 patient contacts (15%) were treatment associated, 384 patient contacts (52%) were tumor related, the remaining (248, 33%) were unrelated to either. In 533 cases (72%) inpatient treatment was necessary. The average length of stay was 9, 36 days. Furthermore the 3MM was significantly higher in elderly patients > 65y (p = 0,001), palliative patients not undergoing active treatment (p = 0,003) and patients with elevated CRP levels ( > 0,5mg/dl) (p = 0,001) at time of ED contact. In addition in our univariate analysis factors that significantly decreased the OS were age > 65, visceral metastasis and palliative patients without active treatment. Conclusions: The majority of cancer patients in this study were in a palliative setting. Moreover, cancer associated complications posed the most frequent cause for ED consultation. We could identify a higher risk for mortality for elderly patients, patients with visceral metastasis and patients undergoing best supportive care. The results may help to inform both cancer patients and primary care units about frequent complications.
Qualifying sites for oncology clinical trials.
Authors: Kurbegov Dax , Kim Edward S. , Hurley Patricia A. , Waterhouse David Michael 
Published: May 2019

6619 Background: Current methods to assess trial sites for clinical trial participation are onerous, with unnecessary redundancies and “no-value” steps that impact clinical trial participation. This project assessed the impact of current sponsor and contract research organizations (CRO) methods to evaluate sites for trials. Methods: A survey was conducted with community- and academic-based trial sites. Samples of feasibility questionnaires (FQs) used by sponsors and CROs were also compiled. An ASCO sponsored multi-stakeholder meeting was held to identify strategies to more effectively assess trial sites. Results: 113 oncology practices (63 community, 50 academic) reported completing 11 FQs and 4 pre-study site visits (PSV) on average per month. On average, each FQ took 4 hours (528 hours/site and 59,664 hours for all respondents, annually) and each PSV took 10 hours (480 hours/site and 54,240 hours for all respondents, annually) to complete. Thus, the total staff hours required to complete site feasibility assessments was 113,904 annually. Respondents reported that content in both FQs (82%) and PSVs (91%) was redundant to information previously provided and FQs were redundant between different sponsors (86%). The 42 sample FQs had a median 45 questions (range 13 to 96). Respondents noted that sponsors/CROs provided insufficient study documentation to accurately complete FQs. It took 7 months on average from first contact to first patient enrolled. Respondents also provided feedback about standardizing and streamlining site qualification processes. Conclusions: The current methods of assessing site feasibility for clinical trials poses tremendous burden on site resources and is not sustainable. New methods are needed that standardize, harmonize, and streamline criteria and site assessments. Such changes will reduce burden and costs for all stakeholders, and will expedite and increase patient enrollment onto clinical trials.
Decreasing postoperative opioid prescriptions in ambulatory extended recovery patients.
Authors: Fearon Nkechi , Chesnut Gregory Thomas , Benfante Nicole , Assel Melissa , Mauzoul Shirley , Levine Marcia , Broach Vance , Vickers Andrew , Eastham James Andrew , Twersky Rebecca , Simon Brett A , Laudone Vincent Paul 
Published: May 2019

6621 Background: Over-prescription of opioids after surgery contributes to the opioid abuse epidemic. Optimum post-operative opioid dosing is not defined. We evaluated prescribing patterns among different surgical services and created a standardized practice to reduce dispensation of unnecessary opioids. Methods: Opioid-naïve patients over 18 who underwent urologic, gynecologic, or breast surgery between March 2018 and January 2019 were eligible. A 4-month pre-intervention evaluation of number of opioid pills prescribed, number of pills taken, additional refills, and pain-control was obtained by contacting patients 7-10 days post-operatively. Findings were used to standardize prescriptions. Following implementation, patients undergoing surgery for the following 4-months were contacted to assess the impact of standardized opioid prescriptions. Data was compared with the institution’s electronic prescription system. Results: Pre-intervention, 368 eligible urology and gynecology patients (75.6%) responded and were prescribed between 6 and 40 opioid pills. Urology patients received median 28 (20, 30) tablets and 33% reported taking none. Gynecology patients received a median 20 (19, 28) tablets and 41% took none. Of 238 mastectomy patients, 176 (74%) reported taking median 3 and 4.9 of 20 prescribed opioid pills and 39% or 61% took no opioid pills (without vs with reconstruction). Prescriptions were standardized to 8, 7, and 10 tablets for urology, gynecology, and breast services. Post-intervention surveys revealed opioid tablets taken to be unchanged with minimal increase in refill requests. Conclusions: Prior to standardization, a large variation in opioids prescribed was observed. Standardizing opioid prescriptions resulted in fewer opioids dispensed without impacting pain control or refill requests.
Relationship of emergency department use pre- and post-cancer diagnosis in safety-net adults.
Authors: Hong Arthur , Sadeghi Navid , Cox John Vernon , Lee Simon Craddock , Halm Ethan 
Published: May 2019

6626 Background: Safety-net adults generate a high rate of emergency department (ED) visits within the 180 days after a new cancer diagnosis, many of which could be alternatively triaged to an urgent care clinic. It is unclear how much of this ED use is attributable to the cancer and treatment vs. ED-seeking behavior. To identify patients at risk of frequent ED use, we explored whether a patient’s pre-cancer ED visit use predicted ED use after diagnosis. Methods: We identifiably linked adults from the tumor registry in the Dallas County safety-net health system to a regional hospital database with claims-like data for all patients from 98% of non-federal hospitals in North Texas. We applied a mixed-effects multivariate logit model, using frequent ED use (≥4 visits) in the 6-12 months or 12-18 months before diagnosis to predict frequent ED use after diagnosis, adjusting for demographics, comorbidities; cancer type, stage, initial treatment modalities; and grouping visits at the patient level. Results: Of 8,610 adults diagnosed from 2012-2016, 76.2% had Medicaid or were uninsured, 30.9% had lung, breast, or colorectal cancer, and 25.9% had advanced-stage cancer at diagnosis. In the 180 days after diagnosis, 42.5% of patients had zero ED visits, 45.7% had 1-3 visits, and 11.8% were frequent ED users (≥4). In multivariate analysis, patients with frequent ED use in the 6-12 months before a cancer diagnosis had 6.7 higher odds (95% CI: 4.8, 9.3) of having frequent ED use after diagnosis, compared to patients who had zero ED visits prior to diagnosis. This compared to 1.3 higher odds (95% CI: 1.1, 1.5) of frequent ED use if the patient had advanced-stage cancer, and 2.1 higher odds (95% CI: 1.8, 2.4) if chemotherapy was part of initial treatment. Although most post-diagnosis frequent ED users generated zero visits (62.2%) or 1-3 visits (30.7%) in the 6-12 months prior to diagnosis, 38% of patients with frequent ED use pre-diagnosis continued frequent ED visits after diagnosis. Results were similar for ED use 12-18 months prior to diagnosis. Conclusions: Among safety-net adults, prior ED-seeking behavior strongly predicted ED use after a new cancer diagnosis. This may represent a high-risk group that might benefit from care delivery innovation.