bluuebunny/crossref_metadata_2025_split huggingface dataset:
Attrition rates, reasons, and predictive factors in supportive/palliative oncology clinical trials at a comprehensive cancer center.
Authors: Glitza Isabella Claudia , Hui David , Bruera Eduardo , Chisholm Gary B. 
Published: February 2017

108 Background: Attrition is common among supportive/palliative oncology clinical trials. Few studies have documented the reasons, and predictors for dropout. We aimed to determine the rate, reasons, and factors associated with attrition both before reaching the primary endpoint (PE) and the end of study (EOS). Methods: We conducted a review of all prospective interventional supportive/palliative oncology trials in our department between 1999 to 2011. Patient and study characteristics and attrition data were extracted. Results: 1,214 patients were included in 18 clinical trials. The median age was 60, performance status ≥3 41%, median fatigue 7/10, and median dyspnea 2/10. The attrition rate was 26% (95% confidence interval [CI] 23%-28%) for PE and 44% (95% confidence interval 41%-47%) for EOS. Common reasons for EOS dropout were patient preference (N=93, 17%), symptom burden (N=87, 16%), death (N=45, 8%), and hospital admission (N=43, 8%). At the patient level, EOS attrition was associated with Hispanic race (OR=1.88, 95% CI 1.27-2.78), higher baseline intensity of fatigue (odds ratio [OR]=1.09 per point, 95% CI 1.02-1.16), and dyspnea (OR=1.06, 95% CI 1.02-1.11) in multivariate analysis. At the study level, longer study duration (Spearman correlation 0.59, P=0.01) and outpatient studies (47% vs. 6%, P=0.05) were also associated with higher EOS dropouts. Higher dyspnea, fatigue, and longer study duration were associated with PE attrition. Conclusions: The attrition rate was high amongsupportive/palliative oncology clinical trials, and was associated with various patient characteristics and high baseline symptom burden. These findings have implications for future study designs including eligibility criteria and sample-size calculation.
Improving the quality of abstract reporting for economic analyses in oncology.
Authors: Ho Maria Yi , Chan Kelvin , Peacock Stuart , Cheung Winson Y. 
Published: February 2017

109 Background: Increasing costs of cancer drugs underscore the importance of EA, which convey key information about the relative costs and benefits of new interventions. Although guidelines for abstracts exist for phase I, II, and III oncology trials, similar recommendations for EA are lacking. Our objectives were to 1) identify items considered to be essential for EA abstracts; 2) evaluate the quality of EA abstracts submitted to ASCO, ASH, and ISPOR meetings; and 3) propose guidelines for future reporting. Methods: Health economic experts were surveyed and asked to rate each of 24 possible EA elements on a 5-point Likert scale. A scoring system for abstract quality (0=poor and 100=excellent) was devised based on EA elements with an average expert rating ≥ 3.5. All EA abstracts from ASCO (‘97–‘09), ASH (‘04–‘09) and ISPOR (‘97–‘09) were reviewed and assigned a quality score. Results: Of 99 experts surveyed, 50 (51%) responded. Characteristics of respondents: average age = 53; male = 78%; US / Europe / Canada = 54% / 28% / 18%. A total of 216 abstracts were reviewed: ASCO 53%, ASH 14% and ISPOR 33%. Median quality score was 75 (range 48 to 93), but notable deficiencies were observed. For instance, the cost perspective of the EA was reported in only 61% of abstracts, while the time horizon was described in only 47%. An association was seen between year of presentation and overall quality of abstracts (p=0.001), with those from recent years demonstrating better quality scores. There were also disparities in quality scores among EA of different cancer sites (p=0.005). Conclusions: Quality of EA abstracts for oncology has improved over time, but there is room for improvement. Abstracts may be enhanced using guidelines derived from our survey of experts (see table). [Table: see text]
Opportunities for better management of cancer in patients receiving chemotherapy at Aurora Health Care (AHC), a large integrated health system in eastern Wisconsin.
Authors: Amin Paragkumar R. , Frick Jacob C. , Bjegovich-Weidman Marija , Mitchell Dorry , Tougas Jessica 
Published: February 2017

110 Background: Cancer patients, especially those on chemotherapy, have complex medical histories. They experience a variety of medical problems from their cancer and treatments. This quality improvement study is designed to collect information about chemotherapy related emergency department (ED) visits to estimate ED utilization rates, recognize patterns and evaluate other confounders. The goal is to assess and reduce ED use at AHC through improved care management. Methods: The one-year data analysis includes any patient who received chemotherapy in an outpatient care setting and had a visit to the ED within 60 days of treatment. Chemotherapy was defined by designated CPT codes combined with a primary cancer diagnosis. Every ED visit was matched to all available chemotherapy visits for each patient, retaining the chemotherapy visit nearest in chronology prior to the ED visit. Data Exclusions: (a) Patients who received chemotherapy outside AHC, and then accessed an AHC ED; (b) Patients who received inpatient chemotherapy. Results: There were 28,738 chemotherapy encounters for 4,264 unique patients system-wide. AHC EDs saw 1,669 visits for 1,048 unique patients within 60 days of chemotherapy (24.6%). The top three cancer diagnoses were 21% thoracic; 21% GI; and 16% lymph/hematopoietic. Of the 1,669 ED visits, 35% occurred within seven days and 77% within 30 days of treatment. Almost half (45.6%) of the ED visits occurred during normal office hours. No significant variation was noted by day of week. An initial focus was on the tertiary center which represented 318 (20%) of the 1,669 ED visits. The most common diagnoses for an ED visit were pain (17%) and deconditioning (17%), followed by infection (11%) and respiratory symptoms (11%). Conclusions: This study documents the ED utilization by AHC chemotherapy patients. Unexpectedly, ED use occurred frequently during normal office hours. Most visits were represented by a limited number of cancer diagnoses and presenting complaints. Intervention is planned to reduce ED use after chemotherapy at AHC through improved patient education and by shifting these visits to less expensive venues when possible.
Building success in quality improvement: An analysis of what barriers hinder and what catalysts promote the widespread adoption of quality improvement initiatives.
Authors: Sause William T. , Ruckdeschel John C. , Belnap Thomas W. , Jones Cory , Rowley Braden D. 
Published: February 2017

122 Background: Quality improvement initiatives and outcomes research activities at Intermountain Healthcare are regularly conducted across 9 clinical domains, including oncology. The purpose of this abstract is to define some of the projects initiated in the primary management of breast cancer and critically analyze the barriers and catalysts allowing for adoption of quality improvement processes. Methods: Between 2003 and 2010 we initiated approximately 15 projects designed to measure and improve quality of care delivery in the treatment of breast cancer. These projects included increasing the use of breast conservation for primary surgical management, reducing axillary dissections for patients with ductal carcinoma in situ and the adaptation of sentinel node biopsy rather than axillary dissection for primary breast cancer. Quality improvement projects involving diagnostic imaging included evaluation of the time from abnormal mammogram to biopsy and the utility of follow-up mammography following breast conservation. Results: Measured variability among practicing clinicians in many instances was substantially reduced or eliminated. Adoption of clinical improvements was most often rapid and noticeable across the entire health care system, however, in some instances quality processes were not completely adopted. The adoption of quality improvement initiatives occurred where obvious clinical benefit could be documented, technical expertise was enhanced and peer supervision existed. Adoption occurred less frequently when financial barriers to adoption existed, clinical benefit was less well defined and peer encouragement was less vigorous. Conclusions: Quality improvement processes across a large healthcare system can be instituted and adopted by a variety of facilities and practicing clinicians. Barriers and catalysts to adoption do exist and this presentation will attempt to document and outline opportunities for success using quality improvement in a large healthcare system.
A quality improvement program within the research setting to improve cancer clinical trial recruitment, accrual, and retention.
Authors: Michaels Margo , Blanchard Judith , Reims Kathleen , Little Kevin , Pokrashevsky Gina 
Published: February 2017

124 Background: Participation in and access to cancer treatment clinical trials (CCTs) is a key measure for delivery of quality cancer care. Yet adult trial participation in the U.S. remains under 3%, with even lower participation rates among minority groups and people over 65. There is little evidence for best practices in CCT accrual. If institutions are to be evaluated by the access they provide to CCTs, it is critical to identify practical, evidence-based approaches to maximize the efficiency of CCT recruitment, accrual, and retention efforts. The National Cancer Clinical Trials Pilot Breakthrough Collaborative (NCCTBC) is the first-ever national effort to identify such best practices in a real world setting. Methods: The purpose of this pilot was to test the feasibility of applying a proven quality improvement process to CCT accrual. More than 150 evidence-based changes to processes and procedures were identified. Five community oncology practices designed, tested, and implemented changes and reported monthly on 6 core measures to gauge improvement. Teams collaborated to share challenges and were provided coaching and technical assistance by national experts. Results: Teams have tested 35 changes over a 10-month period. Outcomes from the pilot are already showing promising results in identifying those changes that can have the most impact on improving accrual. For example: Improvements in race and ethnicity data capture are helping to address disparities in patient census. Improvements in processes for trial menu selection are leading to new ways of assessing patient populations and finding trials that match them. Documentation of pre-screening and offer rates is identifying system gaps and ways to increase these rates. Conclusions: Results affirm the feasibility of applying a quality improvement framework to address persistently low accrual rates and decrease health disparities among racial and ethnic minorities and the elderly. Based on lessons learned, we are making improvements to the NCCTBC infrastructure and processes and plan to recruit 10 new teams to test further changes.
Erlotinib patterns of use and out-of-pocket (OOP) expenses.
Authors: De Souza Jonas A. , Gleason Patrick P. , Starner Catherine I. , Qiu Yang P. 
Published: February 2017

126 Background: Erlotinib is an oral oncology drug FDA-approved for advanced pancreatic and non-small cell lung cancers. Data on its patterns of use, pharmacy dispensing, and patient’s OOP are scarce. Methods: Using integrated medical and pharmaceutical data from 4 Blue Cross Blue Shield plans, we retrospectively identified individuals who received erlotinib between 01/2011 and 06/2011. Their claims were further queried for neoplasm ICD9 codes. A new user was defined as having no erlotinib claims filed in the prior 180 days. All new users were followed for 180 days or until their death/disenrollment (censor date). Excess erlotinib tablets were calculated for individuals with a censor date. The cost of unused tablets was estimated considering the standard 30-day, as well as a hypothetical 15-day drug supply. A gap of 45 days without erlotinib, during the follow-up, was defined as non-persistent to erlotinib therapy. The OOP costs were recorded from their first erlotinib claim. Results: Among 3,357,936 members insured, 125 (40 per million) received erlotinib in the period; 102 members (81.6%) had a lung cancer diagnosis, 18 (14.4%) pancreatic cancer, and 5 (4%) had cancers where erlotinib use is not evidence-based; 31 (24.8%) had a total cumulative supply of less than 30 days suggesting one fill and then discontinuation; 60 patients (48%) were new users in the period, 47 with lung cancer and 12 with pancreatic cancer. Among new users, 27 (45%) died or disenrolled; 18 (30%) of these patients had 211 unused tablets, which amounted to $35,237 or $587 per new user. With a hypothetical 15-day drug supply, there would be 45 unused tablets, totaling $7,515 or $125 per new user. Among the 60 new users, individual OOP on their first claim was < $100 for 38 (63.3%) individuals and > $100 for 22 (36.7%). OOP greater than $100 was associated with a 45-day gap in erlotinib therapy over the 6-month period, p=0.047 (21.0% versus 45.5%). Conclusions: A fourth of patients received erlotinib for less than a month, indicating these patients were either at the end of their lives or had intolerable toxicities. In this cohort, higher OOP costs negatively impacted persistence to therapy. For new users, a care management program with a 15-day drug supply could potentially be a cost-saving approach.
Evaluation of inpatient cancer pain management at an academic medical center.
Authors: Mearis Michael , Shega Joseph , Knoebel Randall 
Published: February 2017

128 Background: The National Comprehensive Cancer Network (NCCN) guidelines on cancer pain management were developed to direct pain assessment and management. The purpose of this study was to assess whether adherence to guidelines was associated with improved outcomes. Methods: One-hundred and nine patients admitted to the inpatient hematology oncology service that received at least one dose of morphine, oxycodone, or hydromorphone were evaluated and allocated into groups based on adherence to the NCCN guidelines. Safety and achievement of analgesia (pain score ≤ 4) at 24-hours after opioid initiation were compared between the two groups. A multivariate analysis was performed to identify predictors of opioid regimens non-adherent to guidelines. Results: Sixty-four percent of patients were initiated on regimens adherent to the NCCN guidelines. 63% of patients initiated on regimens adherent to NCCN guidelines reached the endpoint of analgesia at 24 hours compared to 41% of those who were not (p = 0.028). Adverse events were infrequent (p > 0.5). Opioid tolerance was the variable most predictive of being initiated on regimens non-adherent to guideline recommendations (OR 3.1, 95% confidence interval 1.24-7.82). Conclusions: A significant number of patients presenting with cancer pain are initiated on regimens non-adherent to NCCN guidelines, leading to reduced attainment of adequate analgesia. Opioid tolerant patients are at an increased risk of inadequate analgesia, and should be identified and initiated on proper pain regimens taking home opioid usage into consideration.
Cancer patients’ and physicians’ preferences for decision making regarding pharmacogenomic testing (PGT).
Authors: Cuffe Sinead , Hon Henrique , Qiu Xin , Masroor Sohaib , De Souza Bradley , McFarlane Graham , Wong Chung-Kwun Amy , Tobros Kimberly , Azad Abul Kalam , Hasani Ekta , Rozanec Natalie , Leighl Natasha B. , Atehortua Nelson A. , Alibhai Shabbir M. H. , Xu Wei , Issa Amalia M. , Liu Geoffrey 
Published: February 2017

13 Background: Pharmacogenomics is increasingly utilized in oncology; however, there is little knowledge concerning cancer patients’ or oncologists’ attitudes toward PGT decision-making in clinical practice. Methods: A broad cross-section of cancer patients were interviewed regarding their attitudes toward PGT using hypothetical time, efficacy and toxicity trade-off and willingness-to-pay scenarios (N=278) and/or quantitative choice-based conjoint analysis surveys (N=264); 64 cancer specialists/physicians in training were surveyed similarly. Results: Of patients participating in the trade-off scenario phase of study, >94% accepted chemotherapy, and of these, >98% wanted PGT that identifies a subset of patients either benefiting from chemotheraphy or who were at risk of severe toxicity. Patients were willing to pay between CAD $1,000-$1,900 for PGT and accept wait times for results of 2-3 weeks. Similar findings were observed in the conjoint phase of the study, with preferences for PGT starting to decline when the out-of-pocket costs reached CAD $500-$1,500, wait time for results exceeded 14 days, and when the prevalence of the genetic variant fell below 25%. Adjuvant patients’ acceptance of PGT was most influenced by cost (decision weight [DW]=41%) and prevalence of the genetic variant associated with lack of benefit from chemo (DW=26%). Metastatic patients were most influenced by cost (DW=49%) and wait times (DW=31%). More patients reported difficulty understanding conjoint surveys (14%) than trade-off scenarios (7%; p=0.01). 81% of patients wanted to be involved in decision-making regarding PGT; while 30% of physicians felt it should be a physician-only decision (p=0.006). However, 21% of patients and 5% of physicians admitted to not understanding PGT, while just 14% of physicians rated themselves as very knowledgeable regarding PGT. Conclusions: Cancer patients overwhelmingly accept and want to be involved in decision-making regarding PGT, to a greater extent than what physicians prefer. However, communication of PGT information was a potential barrier, as a considerable minority lacked the necessary knowledge to facilitate informed decision-making. Improved patient and physician education is necessary.
Sepsis in adult leukemia patients.
Authors: Garza Jan 
Published: February 2017

133 Background: Sepsis is estimated to affect 16.8% of the cancer population with hematologic malignancies leading to significant mortality. The incidence may be higher in elderly leukemia patients with concurrent comorbidities. Results of case scenario questionnaires presented to leukemia nurses during a quality improvement project revealed a potential to increase recognition of systemic inflammatory response syndrome, commonly used to identify patients who are at high risk for sepsis, severe sepsis, and septic shock, by 20% among leukemia nurses. Earlier recognition of the systemic inflammatory response syndrome by clinicians is thought to possibly reduce the mortality among those with leukemia. The purpose of this poster is to present the pre-test/post-test results of an educational intervention aimed at increasing earlier recognition of SIRS and consequent sepsis, severe sepsis, and septic shock by 20% among 65 nurses on the leukemia units at a major cancer center. Methods: A multidisciplinary team Pharmacists from ICU and Leukemia and ICU MERIT Team-Leader, led by 2 APNs from ICU and Leukemia, developed and presented an educational program to nurses on the leukemia units to support proposed changes in practice. Pre-test and post-tests were used to determine nurses’ knowledge prior to and after the educational intervention. Results: Analysis of pre- and post-test scores revealed 61% increase in recognition of SIRS, sepsis, severe sepsis, and septic shock. There were no cases of systemic inflammatory response syndrome identified among the 29 leukemia patients by nurses prior to the intervention compared to 9 out of 16 post intervention. Conclusions: Education of nurses on leukemia units revealed an increase in their knowledge base and improvement in recognition of SIRS, sepsis, severe sepsis and septic shock. Implications for nursing include a need to incorporate this education to all nurses who are assigned to units caring for hematologic malignancies to include lymphoma, stem-cell transplant, and myeloma. Our quality improvement project showed the need for on-going healthcare provider education to recognize the symptoms early which may save lives and reduce costs of healthcare.
Avoidance of futile treatment and adverse events by using angiogenesis-specific imaging for early detection of disease progression in patients with first-line metastatic renal cell carcinoma.
Authors: Gruschkus Stephen K. , Bodnar Carolyn , Dhamane Amol , Shah Manan 
Published: February 2017

134 Background: Although sunitinib is effective first-line therapy (1LT) for metastatic renal cell carcinoma (mRCC), ~20% of patients experience rapid progressive disease (PD). Traditional RECIST monitoring often does not detect PD until 90 days after 1LT initiation. Investigational angiogenesis-specific imaging (AI) may identify PD as early as 14 days post-1LT initiation, thus allowing a switch to a potentially more effective second-line therapy and avoiding unnecessary risk of AEs. This study’s goal was to quantify the potential reduction in futile 1LT length, AEs, and costs by using AI for early detection of PD. Methods: Decision modeling with a 90-day horizon evaluated a comparator arm using RECIST monitoring at 90 days and an intervention arm using AI at 14 days. Sunitinib costs were $21,250 for the comparator arm and $13,282 for the intervention arm. RECIST costs were $619 and AI costs were tested as a breakeven analysis. A literature review quantified AE rates associated with 1LT sunitinib and claims data were used to determine costs. Early PD detection was estimated based on a 20% rapid PD rate. Results: For AI sensitivity of 50% to predict rapid PD, a 38-day reduction in futile 1LT could be achieved per PD patient by using AI vs. RECIST (AI sensitivity of 75%/100% yielded 57/76 fewer days). The potential number of AEs avoided through early PD identification is shown below. Costs saved per 1,000 mRCC patients were $684,566 for AEs and $3,187,400 for futile 1LT. Based on these results, $3,872 per mRCC patient would be freed up for AI. Conclusions: Continuing 1LT after PD brings unnecessary risk of AEs and delays potentially effective 2nd-line therapy. Results of this study indicate that early PD identification using AI may improve quality of care by minimizing duration of futile 1LT and avoiding unnecessary AEs. [Table: see text]