bluuebunny/crossref_metadata_2025_split huggingface dataset:
Should pregnancy testing during chemotherapy be standardized?
Authors: Berger Natalie S , FitzPatrick Katherine , Klein Paula 
Published: May 2019

e18314 Background: The incidence of cancer diagnosed during pregnancy is 0.1-0.2%. The incidence of women who become pregnant while on chemotherapy is less clear. As the initiative to improve awareness about the risks of infertility in premenopausal women receiving chemotherapy improves, it is also important to reinforce the risk of pregnancy during chemotherapy. Treating patients with chemotherapy, especially during the first trimester, is an absolute contraindication and a serious adverse event. Pregnancy testing prior to the initiation of chemotherapy is recommended by the NCCN and ASCO. However, recommendations on how to monitor for pregnancy after an initial screen are inconsistent and lack standardization. Methods: We surveyed five breast medical oncologists and six infusion nurses at a busy urban breast center to determine their baseline practices for pregnancy counseling and testing. We then initiated a quality improvement project over a six month period to routinely screen premenopausal patients ( < 55 years) diagnosed with breast cancer for pregnancy prior to each cycle of chemotherapy. Results: Of physicians and nurses surveyed, 40% and 33% respectively have diagnosed a pregnancy during chemotherapy. All physicians surveyed check a pregnancy test prior to the initiation of chemotherapy, 60% check urine and 40% check serum. Counseling patients on the risk of pregnancy varies with 80% of physicians counseling patients prior to initiation of chemotherapy. Half of the infusion nurses ask patients if they are concerned they may be pregnant intermittently during chemotherapy and 50% do not ask again after the initial screen. During routine screening over a 6 month period no pregnancies were detected. One patient missed a baseline screening prior to initiating chemotherapy. Two patients had a borderline result ( < 1%) on urine pregnancy testing but reflex serum testing was negative. Compliance for testing by nurses was 93%. Conclusions: Results of the survey demonstrate that pregnancy counseling and screening practices vary even within the same institution. We must improve and standardize educating patients and healthcare providers on the risks of pregnancy during chemotherapy in order to prevent unwanted pregnancies, and identify pregnancies in a timely manner. Given the very small risk of pregnancy, we would not recommend routine screening prior to each cycle of chemotherapy, but we do recommend asking all premenopausal patients if there is a chance they may be pregnant prior to each treatment and test based on the individual risk.
Implementation of ICH E6 (R2) through identification of data risks using analytics in oncology clinical trials.
Authors: Hayward Colin , Youssef Emile , Nezos Melissa , Jendrasek Debra 
Published: May 2019

e18319 Background: ICH E6 (R2) has increased the level of scrutiny that we have for the data we collect in clinical trials. The emphasis is on quality-by-design with a quality management system to be incorporated and a focus on using a risk-based approach. This can be time-consuming and expensive - though the goal of this addendum is to improve quality AND efficiency, whilst ensuring patient safety and integrity of trial results. We therefore, piloted a proactive, concise and consistent method for utilizing a risk-based approach with central monitoring. Methods: Our method included 1) identifying risks within our data with 8 standard Key Risk Indicators (KRIs) across different study phases and different therapeutic areas together with 2) an off-the-shelf web-based tool for uniform and efficient review by a team of central monitors to assess which data may need more examination. These 8 KRIs are indicated in the list below, in order of the categories within the TransCelerate Risk Assessment and Categorization Tool: (S)AE rates, Enrollment Rates, Screen Failure Rates, Discontinuation Rate, Protocol Deviation Rates, Overdue Query Rate, Data Latency, and Identification of Potential Fraudulent data. Results: 15 studies were configured with the same KRIs and Visual Analytics; histograms, line- and pie-charts and data tables allowing for interactive data visualization and drill down. This represents research across different Phases 1-3 and observational studies. Based upon qualitative survey analysis from the central monitoring team 5/8 KRIs were found to be extremely valuable to focus on study quality, identifying earlier issues in study conduct for the project teams and Sponsors, while the remaining 3 were less valuable. Conclusions: We Our Risk Management team aims to increase the quality of data and ease of implementation of ICHE6 (R2) by focusing on the areas that matter the most, however identifying those areas and managing those data can sometimes be challenging. Through this innovation we have proven some core KRIs of trials that should be most closely monitored to aid decision making and will continue to evaluate to develop core oncology specific KRIs that will allow a more consistent review of data.
Implementation of malignant bowel obstruction multidisciplinary case conferences (MCCs) to improve clinical decision making in malignant bowel obstruction (MBO) in gynecologic oncology.
Authors: Bhat Gita , Madariaga Ainhoa , Bonilla Luisa , Lee Yeh Chen , Dhani Neesha C. , Jivraj Nazlin , Chawla Tanya , Buchanan Sarah , Ferguson Sarah , O'Brien Catherine , Dhar Preeti , Shlomovitz Eran , Lau Jenny , Mulumba Susan , Karakasis Katherine , Chllamma Muralidharan , Oza Amit M. , Lheureux Stephanie 
Published: May 2019

e18322 Background: Though patients (pts) with gynecological cancer are at higher risk of MBO, clinical management is not well defined. We implemented a coordinated team approach to evaluate MBO at Princess Margaret Cancer Centre. The Princess Margaret Cancer Centre inter-professional MBO management program includes nurse led ambulatory symptom management, inpatient treatment algorithm, patient directed bowel management education & MCCs. This study evaluates the utility of MBO MCC on clinical decision making in gynecologic oncology. Methods: Monthly MBO MCCs are conducted to discuss complex clinical management issues. A clinical summary is presented prior to the discussion with each case incorporating radiology review followed by interdisciplinary discussion. In this study, the initial management plan was compared to post-MCC consensus. A change in plan was defined as a consensus plan different from the pre-MCC plan or no definite plan prior to MCC. Barriers to implementation of the consensus were analyzed. Results: From December 2016 to November 2018, 90 pts were discussed in 22 MCCs. Of these, 60 had high grade serous ovarian carcinoma (67%) & 64 had small bowel obstruction (71%). Discussion in MCCs lead to a change in management plan in 49 cases(54%). These changes included recommendations for palliative surgery (25%) or radiation (10%), interventional radiology (23%), pharmacologic management alone (14%), imaging studies (4%) & total parenteral nutrition (TPN) (4%). Chemotherapy continuation, break or regimen changes were recommended in 20%. MCC consensus plan could not be implemented in 11 cases (23%). The barriers were refusal of surgery (8%), interventional radiology procedures (2%), TPN (4%) by patients, functional decline (6%) & inability to create a colostomy due to dense adhesions (2%). During MCC referrals to the dietitian & palliative care team were planned for 16 (18%) & 22 (24%) pts respectively. Conclusions: Interdisciplinary MBO MCCs have a significant impact on decision making in complex MBO cases. Radiology review & group discussion facilitates greater clarity in formulation of a management plan.
Assessment of end-of-life care quality indicators in veterans with cancer.
Authors: Suero-Abreu Giselle Alexandra , Johnson Camille Michelle , McKenna Marshall , Wang Jun Chih , Barajas-Ochoa Aldo , De Silva Piyumika , Perez Arturo , Zhong Fengming , Srinivas Shanthi , Chang Victor Tsu-Shih 
Published: May 2019

e18327 Background: Many cancer patients (pts) receive aggressive medical care at the end-of-life (EOL) . The objective of this study was to assess quality of EOL (qEOL) care in cancer pts at our VA and to determine the implementation of do-not-resuscitate (DNR) orders. Methods: Records of Veterans followed at the VA NJ Health Care System who died from 2015-2017 were reviewed. The qEOL care was assessed using seven indicators by Earle et al. ( J Clin Oncol. 2003;21(6):1133-1138). EOL planning (use of DNRs and use of palliative and hospice services) was also assessed. Results: We identified 92 male pts with cancer (mean age 73 years ±10). There were Caucasian (n = 48, 52%) and African American (n = 38, 41%) pts. The most common malignancies were lung (22%), gastrointestinal (21%), prostate (16%) and hematological (14%). 87 pts (95%) had a DNR order at the time of death; the DNR was obtained a median of 60 days prior (IQR 7-135). Ten pts (11%) had DNR orders placed within 1 week of death. Seven pts (8%) received chemotherapy in the last 14 days of life while 6 pts (7%) received a new treatment in their last 30 days. In the last month of life, 35 pts (38%) had multiple hospitalizations and ER visits, 20 pts (22%) were admitted to the intensive care unit, 9 pts (10%) were intubated, and 3 pts [3%] received cardiopulmonary resuscitation. More pts (n = 47, 51%) died in an acute care setting, and 45 (49%) pts were admitted to hospice (median of 22 days before death, IQR 6-52). Four pts (4%) were admitted to hospice within 3 days of death. A next-of-kin was available for 64 pts (70%). Palliative care (PC) was provided to 83 pts (90%) and pain medications prescribed for 80 pts (87%). Conclusions: There was timely implementation of DNRs and referral to PC. The qEOL indicators used suggest that aggressive treatments were appropriately being held at the EOL. However, there was an increased use of acute care services. Limitations include lack of data on Veterans who died outside the VA. This data supports future quality improvement EOL interventions. [Table: see text]
How will the cost of biosimilars affect patients’ willingness to receive them?
Authors: Harvey R Donald , McGrath Megan , Cook John W. , Dixon Margie D , Pentz Rebecca D. 
Published: May 2019

e18338 Background: The cost of oncology care is increasing. The NIH projects that the oncology drug market will reach $111.9 billion by 2020. Studies show that oncology patients experience considerable financial burden, regardless of insurance status and in general believe that oncology medications are too expensive. However, there is some evidence outside of oncology that suggests patients may not trust generics or cheaper medications. Therefore, there is a need to assess oncology patients’ views of a biosimilars and their potential to reduce costs. Methods: We surveyed a convenience sample of 79 oncology patients in clinics and the infusion center. The survey consisted of five questions on cost and patient participation in decision making. Results: Of 79 patients approached, 75 (95%) completed the survey. Fifty (66%) believed that expensive medications do not work better than less costly ones for the same disease; yet only 30 of those 50 (60%) and 44% overall (33/75) would prefer that their doctor prescribe them the cheaper version of their anti-cancer medication. Of the 20 respondents who believed that expensive drugs do not work better but still wanted the more expensive drugs for themselves, 8 believed cancer was too serious of an illness to take any chances with a cheaper medication, 5 wanted the most expensive that insurance would cover and 2 wanted the best possible medication. 90.67% respondents (68/75) wanted to know if their physician was prescribing a cheaper version of their drug. Conclusions: Our results show that, overall, oncology patients agree that cheaper medications work as well as more expensive ones, but there are definite concerns among some patients that drug price may be a proxy for quality, particularly in cancer. Overcoming these negative perceptions among patients will be important if optimal cost savings are going to be realized with expanded biosimilar use.
Cost-effectiveness of primary prophylaxis with pegfilgrastim in early-stage breast cancer patients receiving chemotherapy in China.
Authors: Xia Wen , Wang Shusen , Hu Hao , Xu Fei , Jiang Kuikui , Yuan Zhongyu , Shi Yanxia , Zhao Kun , Huang Jia Jia , Xue Cong , Bi XiWen , Lu Qianyi 
Published: May 2019

e18349 Background: Guidelines recommend primary prophylaxis(PP) use for patients receiving chemotherapy regimens with a high risk of febrile neutropenia (FN), which is 20% or higher. This study aim to evaluate the cost effectiveness of PP with pegfilgrastim (Brand name:Jinyouli), PP with filgrastim or no prophylaxis in women with early-stage breast cancer(BC) in China. Methods: A two-phase Markov model was developed for a hypothetical cohort of patients age 45 with stage II BC. First phase modeled costs/outcomes of 4 cycles docetaxel combined cyclophosphamide(TC×4) chemotherapy, with assumptions based on literature reviews including FN rates(Base-case (DSA range),0.29(0.24–0.35)) and related events (FN case-fatality, 3.4 (2.7–4.1)). Second phase models the long term survival which was suggested to link with the relative dose intensity (RDI)( Mortality HR for RDI < 85% vs. ≥85%,1.45 (1.00–2.32)). Clinical effectiveness, costs, and utilities were estimated from peer-reviewed publications and expert opinions in case of unavailability of published evidences. Results: Compared to PP filgrastim and no prophylaxis, PP pegfilgrastim was associated with higher costs 5208.19RMB and 5222.73RMB respectively, and increased quality-adjusted life-year (QALY) gained 0.066 and 0.297 respectively. Accordingly, the incremental cost effectiveness ratios (ICERs) are 79146.3RMB and 17558.77 RMB per QALY, which are both below the three times GDP per capita as the willingness to pay (WTP) threshold suggested by the WHO. Conclusions: Although the cost of PP pegfilgrastim is higher, considering the additional benefits, the administrating of PP pegfilgrastim is likely to be a cost-effective alternative to PP filgrastim and no prophylaxis in patients with early stage breast cancer in China.
Modeling an oncology outcomes-based contract using a blockchain database approach: Cost and technology considerations.
Authors: Hinkel Jennifer M. , Ray Arka , Brar Sirtaj , Lalmalani Rahul 
Published: May 2019

e18360 Background: Cost of care is an ongoing concern for all oncology stakeholders. Outcomes Based or Risk Sharing contracts are increasingly discussed, but difficult and costly to implement. The literature notes barriers of outcomes definition, reliable data sources, and technology enablement. The authors sought to design and test software that could enable faster, lower-cost, and auditable administration of such contracts. Methods: The authors developed software using blockchain databases and transactional proof of work to simulate such a contract and to compare the financial result to usual fee-for-service reimbursement (FFSR). The software processed a synthesized Medicare claims dataset and Average Sales Price (ASP) data from 2008-2010, looking for use of the Bevacizumab(BV)/Carboplatin/Paclitaxel(CP) regimen in non-small cell lung cancer (NSCLC). The contract hypothesized a scenario that offered payers a discount for “underperforming” BV doses (defined as doses given to a patient with < 9 mo. BV duration) and required a bonus payment for “overperforming” BV doses (defined as doses given to a patient with > 14 mo. BV duration). These parameters were selected based on survival data supporting the 2007 FDA approval of BV/CP in 1L tx of advanced nonsquamous NSCLC. Results: The software successfully processed the claims dataset and projected financial results (additional/saved cost) to the payer in this hypothetical contract compared to FFSR. The software also enabled comparison of different hypothetical contracts, inclusion/exclusion rules for claims, and discount structures. The software accurately categorized doses according to the defined logic. Conclusions: Outcomes based contracts have potential for better aligning oncology reimbursement with meaningful results, particularly for costly therapeutics and where patient response or outcome is difficult to predict. While such agreements are recognized as difficult to implement, a software platform that facilitates efficient and scalable design, simulation, and implementation of such agreements, under constraints of real world data availability and sharing, may advance their adoption.
Frequency and causes of oncologists’ burnout in community practices.
Authors: Nabhan Chadi , Bapat Bela , Smith Yolaine , Klink Andrew , Feinberg Bruce A. 
Published: May 2019

e18375 Background: Physician burnout, which is often characterized as exhaustion of physical or emotional strength because of prolonged stress or frustration, has become a worsening phenomenon in medicine. Some have suggested that the rate of burnout among oncologists may be higher than other specialties. Methods: US oncologists/hematologists were queried via a web-based survey from Sep-Nov 2018. Physicians were asked about frequency of burnout symptoms, drivers of burnout, and management of increasing workload. Results: Among the 163 physicians surveyed, 46.0% felt substantial amount of stress at work. Most physicians felt emotionally (85.3%) and physically (86.5%) exhausted. Majority of physicians felt lethargic (66.9%), ineffective (63.8%), and/or detached (62.6%). Additionally, 57.1% of physicians described their practice atmosphere as busy or very busy. In a typical workweek, 92.6% stated they needed additional time, beyond time allocated to clinical care, to complete work responsibilities (23.3% needed 1-3 hours; 15.3% needed ≥10 hours). Most (81.6%) physicians felt lack of work life balance as one of their main stressors. Electronic health record (EHR) responsibilities caused moderate to excessive stress among 66.9% of physicians, 79.1% physicians worked on EHR at home. Other sources of excessive stress were changing reimbursement models (33.1%), interactions with payers (31.3%), increasing patient and caregiver demands (30.7%). Due to increasing demands, 19.6% physicians have considered retiring early, while 14.7% physicians have considered changing their career path. However, 62.6% of physicians stated they had optimal or good control over their workload. To combat burnout, physicians’ practices have used following strategies: employed APPs (46.0%), invested in information technology (33.1%), and/or hired additional administrative staff (31.3%). Conclusions: Most oncologists in the US experience burnout and require additional time beyond that allocated to clinical care to complete their workload. The discordance between oncologists feeling burdened by stress and exhaustion while claiming good control over those same burdens is noteworthy. Additional follow-up will assess whether remedial strategies are effective.
Do the ASCO Value Framework and the ESMO Magnitude of Clinical Benefit Scale measure Absolute or Relative clinical benefit?
Authors: Saluja Ronak , Everest Louis , Cheng Sierra , Cheung Matthew C. , Chan Kelvin K. 
Published: May 2019

e18378 Background: It is unclear whether the clinical benefit scores from the ASCO or ESMO valuation frameworks were intended to measure absolute or relative survival benefit. To empirically examine the measurement characteristics of these frameworks, we compared their survival efficacy components (ASCO-CBS and ESMO-PMCBGs) with established measures of absolute (median survival difference and restricted mean survival time (RMST) difference) and relative (HRs) survival benefit. Methods: FDA’s Hematology/Oncology Approvals and Safety Notifications pages were reviewed to identify phase III RCTs cited in oncology drug approvals between January 2006 and December 2017. In our primary analysis, ASCO-CBS and ESMO-PMCBGs were calculated for the included trials using the framework defined endpoint (Fr). Sensitivity analyses were conducted by calculating the scores using 1) Fr + tail-of-curve bonus points (ASCO) or long-term plateau adjustments (ESMO) (defined as Fr + TOC), 2) overall survival (OS) data only, and 3) progression-free survival (PFS) data only. For both primary and sensitivity analyses, Spearman correlation coefficients were calculated to examine the relationships between 1) ASCO-CBS/ESMO-PMCBGs and RMST difference, 2) ASCO-CBS/ESMO-PMCBGs and median survival difference, and 3) ASCO-CBS/ESMO-PMCBGs and HRs. Results: 107 RCTs were included. Compared to measures of absolute survival, ESMO-PMCBG showed low-moderate correlations with RMST difference and moderate-high correlations with median survival difference (Rho = 0.44 and 0.64, respectively). ASCO-CBS showed low-moderate correlations with both measures of absolute benefit (Rho = 0.43 and 0.44 for RMST difference and median survival, respectively). Compared to a relative measure of survival (HRs), ESMO-PMCBG revealed a moderate correlation (Rho = 0.47) while ASCO-CBS showed a higher correlation (Rho = 0.76). Conclusions: Both frameworks do not perform solely as absolute measures of survival benefit. We recommend that the frameworks consider incorporating a direct measure of absolute clinical benefit, such as RMST difference, into the survival efficacy components of their algorithms.
Patterns of healthcare utilization in patients with newly diagnosed advanced lung cancer.
Authors: Ray Emily Miller , Hinton Sharon Peacock , Reeder-Hayes Katherine Elizabeth 
Published: May 2019

e18386 Background: Advanced lung cancer (ALC) is a symptomatic disease that is often diagnosed in the context of hospitalization. The index hospitalization may be a window of opportunity to improve cancer care delivery. We aimed to define the frequency of ALC diagnosis associated with hospitalization and the relationship to subsequent cancer care and readmissions. Methods: We identified patients in the SEER-Medicare database with: ALC (stage IIIB-IV non-small cell or small cell), diagnosed 2007 to 2013; with continuous enrollment in Medicare from 6 months prior to lung cancer diagnosis through death or 12/2014; and an index hospitalization within 7 days of their ALC diagnosis. Our primary outcomes of interest were 30-day re-hospitalization and emergency department (ED) use. We examined: utilization of services during index hospitalization, including intensive care and oncology or palliative care consultation; discharge destination; receipt of systemic therapy; and hospice enrollment. Results: Fifty-four percent (n = 28,976) of ALC patients had an index hospitalization, with 90% of those having their cancer diagnosed while hospitalized. During their index hospitalization, 16% had oncology consultation, and 6% had palliative care (PC) consultation. Thirty-three percent were in the intensive care unit. At discharge, 59% returned home, 8% died, and 11% went to hospice. Of those who survived to discharge, 69% later returned to the ED or were re-hospitalized, with 49% of re-hospitalizations and 35% of ED visits occurring within 30 days of the index hospitalization. Thirty-five percent of these patients eventually received systemic treatment for their cancer. By 180 days post-discharge, 77% had enrolled in hospice with a median of 10 days on hospice care. Conclusions: Newly diagnosed ALC patients are high risk for acute care utilization, and many patients experience a return to the hospital early in their cancer trajectory. These patients may benefit from additional health system support prior to hospital discharge to help prevent high-cost, low-value healthcare utilization.