bluuebunny/crossref_metadata_2025_split huggingface dataset:
Risk of infectious, hematological, and gastrointestinal side effects in patients treatedwith ibrutinib: A systematic review and meta-analysis of randomized controlled trials.
Authors: Zaw Myo , Thein Kyaw Zin , Tun Aung , Tijani Lukman , Guevara Elizabeth 
Published: September 2018

e18265 Background: Bruton’s tyrosine kinase (BTK) is essential for signaling of B-cell and chemokine receptors. Ibrutinib targets BTK and has become frontier in many hematologic malignancies. We undertook systematic review and pooled analysis of randomized controlled trials (RCTs) to determine infectious, hematological and gastrointestinal risks associated with ibrutinib. Methods: We performed a comprehensive literature search using MEDLINE, EMBASE databases and meeting abstracts through December 31, 2016. The RCTs that mention infectious, hematological and gastrointestinal side effects as adverse effects were incorporated in the analysis. Mantel-Haenszel method was used to calculate the estimated pooled risk ratio with 95% confidence interval (CI). Results: Four RCTs with a total of 1505 patients were eligible for the analysis. Studies compared Ibrutinib (I) vs ofatumumab, I vs chlorambucil, I+ bendamustine (B)+ rituximab (R) vs placebo + B+ R and I vs temsirolimus were included in the analysis. The relative risks (RR) of all-grade side effects were as follows: infection, 1.34 (95% CI: 1.04 – 1.74; p = 0.02); pneumonia, 1.16 (95% CI: 0.82–1.66; p = 0.38); anemia, 0.77 (95% CI: 0.64 – 0.93; p = 0.007); neutropenia, 0.99 (95% CI: 0.87 – 1.14; p = 0.98); thrombocytopenia, 0.86 (95% CI: 0.71 – 1.04; p = 0.12); diarrhea, 1.74 (95% CI: 1.48 – 2.05; p < 0.0001); nausea, 0.94 (95% CI: 0.80 – 1.10; p = 0.45); and vomiting, 0.98 (95% CI 0.74 – 1.30; p = 0.93). The RR of high-grade adverse effects were as follows: febrile neutropenia, 1.32 (95% CI: 0.84 – 2.08; p = 0.21); infection, 1.20 (95% CI: 0.73 – 1.98; p = 0.45); pneumonia, 1.22 (95% CI: 0.76–1.95; p = 0.39); anemia, 0.48 (95% CI: 0.33 – 0.71; p < 0.0001); neutropenia, 0.99 (95% CI: 0.86 – 1.15; p = 0.94); thrombocytopenia, 0.61 (95% CI: 0.47 – 0.81; p = 0.001); diarrhea, 1.72 (95% CI: 0.88 – 3.34;p = 0.10); nausea, 2.56 (95% CI: 0.59 – 10.99; p = 0.20); and vomiting, 0.42 (95% CI 0.11 – 1.63; p = 0.21). Conclusions: Ibrutinib increased the risk of all-grade diarrhea and infection whereas the risks of all-grade anemia, high-grade anemia and thrombocytopenia were significantly lower in the study arm, favoring ibrutinib.
Enhancing clinician confidence on the therapeutic management of non-small cell lung cancer (NSCLC) through continuing medical education (CME).
Authors: Jaganathan Hamsa , Roc Anne , Socinski Mark A. , Turell Wendy 
Published: September 2018

e18271 Background: The evolving strategies to personalize NSCLC treatment have challenged clinicians to remain abreast of and integrate targeted therapy into practice. To address this challenge, 2 CME programs on NSCLC were developed in 2 formats (1-hour cumulative program and a series of 3-1 hour specified programs). Participant responses were compared between the 2 formats to examine differences in learner confidence and competence regarding the management of NSCLC with targeted therapy. Methods: PlatformQ Health developed and executed 2 virtual CME programs in NSCLC. The first program, broadcast in August 2015 and offered for 6 months, attracted 225 learners. This 1 hour program reviewed the latest data of EGFR inhibitors (EGFRi), ALK inhibitors (ALKi), and immunotherapy. In 2016, these 3 topics were divided into a series of 3-1 hour CME programs and offered across the year, which has attracted 371 learners. Survey-based evaluations targeted self-reported clinician data on competence (via patient case studies) and confidence. Results: As of January 2017, learner surveys from EGFR- and ALK-focused education were analyzed. It was observed that learners gained more confidence in managing EGFRi-related toxicities after the 2016 serial education vs the 2015 cumulative education (62% vs 43%, respectively). Learners also felt more confident when evaluating data of available and emerging ALKi (49% vs 35%). Greater competence in management was observed with serial vs cumulative education regarding EGFRi (42% and 15%, respectively) and ALKi (30% and 4%) therapies. Both programs demonstrated a high learner commitment to change in: medical and practice knowledge (93% and 91%, respectively), care attitudes (87% and 87%), practice behavior (85% and 79%), and patient clinical outcomes (86% and 77%). Data analysis on immunotherapy education is ongoing. Conclusions: Overall, education on targeted therapy for NSCLC have demonstrated positive learner outcomes. However, designing education in a serial format that dives deeper into each therapeutic target class affords greater improvements in clinician confidence and learner competence in the therapeutic management of NSCLC.
Electronic calculation of quality measures in the EMR and dependence on data capture in structured fields: The OCM quality reporting experience.
Authors: Hamrick James , Revol Cindy , Parulkar Rohit , Lemmers Olaf , Gippetti James , Bauer-Levey Nick , Lee DJ , Fugaro Alison , Green Robert J , Abernethy Amy Pickar , Kolodziej Michael A. 
Published: September 2018

e18278 Background: Reporting of quality measures is ideally achieved electronically. This is dependent on presence of data elements in structured fields. We report on the variability of quality measure reporting in the OCM for quality measures OCM 8 (adjuvant chemotherapy in stage 3 colon cancer), 9 (adjuvant chemotherapy in HR- breast cancer), 10 (adjuvant trastuzumab for Her2+ breast cancer), and 11 (adjuvant hormonal therapy for HR+ breast cancer). Methods: Quality measures were calculated for 30,524 patients across 35 practices participating in the OCM. We examined the calculation of quality metrics OCM-8, 9, 10, and 11 based on presence or absence of data elements in the medical record. Results: For quality measures OCM-8 and 9 that require documentation of date of surgery, only 1.3% and 1.6%, respectively, of patients could be included in the calculation due to absence of surgical date in a structured field. For quality measures OCM 9 and 11 that require attestation of surgical staging of breast cancer, this data element was documented in 0% of patients. For OCM 9 and 10 that require stage documentation of breast cancer, this data element was documented in 63% and 75%, respectively, of patients (range 12-100%). In cases where staging criteria were not met, 58% and 44%, respectively, of patients were removed due to total absence of staging data in structured fields. Conclusions: Quality measure calculation and reporting is highly dependent on documentation of data elements in structured fields. Lack of documentation of key elements distorts calculation of the measure. Modification of physician workflow or restructuring of measure calculation to optimize use of well documented structured elements will improve generalizability of quality measure reporting. Manual abstraction of data does not represent a feasible alternative.
The impact of continuing medical education (CME) programs in metastatic castration-resistant prostate cancer (CRPC).
Authors: Jaganathan Hamsa , Roc Anne , Armstrong Andrew J. , George Daniel J. , Turell Wendy 
Published: September 2018

e18280 Background: The concurrent development of many CRPC treatments within a short period of time has made prospective data on their sequential use and efficacy complicated, which have challenged clinician confidence, knowledge, and competency. Four hours of CME focused on the therapeutic management of CRPC were developed and participant responses analyzed to determine if these challenges were addressed. Methods: PlatformQ Health developed and executed 4 hours of virtual CME programs in CRPC. The 1st 2-hours, broadcast in May 2015 and offered online for 6 months, attracted a total of 545 learners. The 2nd 2-hours, broadcast in July 2016 and offered for 12 months, attracted a total of 345* learners. Survey-based evaluations targeted self-reported clinician data on satisfaction, clinical practice change and observed patient outcome. Clinician participation data and self-reported patients with CRPC seen per week were used in extrapolations of patients impacted by the CME education per week. Results: Between the 2015 and 2016 CME programs, learners gained confidence in their ability to employ a personalized, sequential approach to treat CRPC (12% vs 35%). Overall, 68% of all learners reported a positive clinical practice impact and 59% reported a positive impact on patient experience and/or outcomes as a result of CME participation. Learner commitment to change was consistently observed in both 2015 and 2016 programs in: medical and practice knowledge (90% and 94%, respectively), care attitudes (83% and 85%), practice behavior (79% and 77%), and their patients’ clinical outcomes (76% and 78%). An estimated 4,066 patients in 2015 and 3,374 patients in 2016 were impacted as a result of the education. Conclusions: Outcomes results of 2 years of education on evolving treatment paradigms of metastatic CRPC demonstrate learner improvements in both clinical practice and patient outcomes. Continuing education in the management of CRPC is recommended, particularly on strategies to appropriately sequence treatments, treatment of bone metastases, keeping abreast of new data, and understanding the rationale for investigational agents. *As of Jan 2017, data collection is ongoing
The oncology prognosis and informed consent: Presentation of a new model to best inform patients.
Authors: Garmezy Benjamin , Worden Francis P. , Blumenthal-Barby Jennifer 
Published: September 2018

e18286 Background: Receiving a malignant diagnosis is challenging and patients must be properly informed of their prognosis to make the best decisions for themselves and their families. The general population has a low degree of statistical literacy and therefore approximations should be considered favorable. However, given that half of patients desire quantitative data, physicians must provide this information within a context that is relevant and comprehensible. Single-point median survival data is less meaningful for patient decision-making. What is preferable is that physicians give experience-based estimations on how a patient might compare to the ‘average’. Including this information leads to more informed consent and best follows the ethical principle of autonomy. Methods: This is a novel framework for providing a prognosis that builds upon the multiples-of-the-mean model established in 2010 by Kiely, Tattersall, and Stockler. This framework was derived from original ethics research involving patient preferences, statistical comprehension, healthcare communication, and medical decision-making. Results: Graphical representation of Kiely’s model provides an intelligible view of quantitative data and allows for the physician to include an experience-based estimation. Steps: (1) Draw a Horizontal line, (2) Calculate from median survival data by using five multiples: 0.25 (Worst-Case, 10% of patients), 0.5 (Lower-Typical, 25%), 1 (Median, 50%), 2 (Upper-Typical, 75%), and 3 (Best-Case, 90%), (3) Label the chart using simple time points in months or years (4) Draw a circle over the region that best represents the patient’s expectation, (5) Provide the diagram alongside easy-to-understand language that clarifies the meaning of the numerical data with written likelihood of the occurrence, such as “almost no chance”, “not likely”, “even chances”, “likely”, and “fairly confident”. Conclusions: Kiely’s model has proven an accurate estimation in colorectal, castration-resistant prostate, non-small-cell lung, and metastatic breast cancer. A graphical representation should provide physicians an easy tool to strengthen informed consent and better aid their patients in decision-making.
CT-guided percutaneous radiofrequency ablation in the treatment of stage I thymoma.
Authors: Dong Jun , Geng Xiaojing , Li Wang , Zhang Bei , Xia Liangping , Hu Pili , Peng Roujun , Wu Peihong 
Published: September 2018

e18287 Background: Thymoma is an uncommon tumor originating from the epithelial cells of the thymic epithelium. It is commonly associated with myasthenia gravis. Though surgical resection might provide the hope of curing thymoma, potential risks of invasive trauma and post operation complications still exists. Video-assisted thoracoscopic surgery (VATS) has many advantages over traditional surgery including minor trauma. However, surgeons operating the equipment to perform VATS need to be highly specifically trained. Although CT-guided percutaneous radiofrequency ablation (RFA) has emerged as a minimally invasive and curative treatment in other tumors, it has never been used in the treatment of stage I thymoma. Methods: The current study enrolled 13 patients with stage I thymomas whom refused open surgery or VATS. As a result, all patients received first-line CT-guided percutaneous RFA as treatment. The procedure was clearly described and displayed for clinical promoting. Results: The feasibility and treatment effectiveness were also recorded. The median time of ablation was 15 mins (range, 10 - 20 mins). Minimum blood loss was associated with the puncture. All lesions were completely ablated (13/13, 100%). Only one patient out of thirteen had thymoma recurrence at 35.5 months after initial ablation treatment (1/13, 7.7%) at follow-up period (median 80.5 months, range, 64.6-116.9 months). There was no procedure-related death after RFA treatment. Myasthenia gravis was cured in most patients (10/13,76.9%), alleviated in 3 patients (23.1%). The most common complications recorded were fever (13/13, 100%), incisional pain (13/13, 100%), nausea (38.5%), pleural effusion (69.2%), pneumothorax (69.2%) and hemoptysis (84.6%). Conclusions: It is clinically applicable for CT-guided percutaneous RFA to be considered as a safe and effective treatment in stage I thymoma.
Comparison of IHC testing for HER-2 in breast cancer specimens before and after adoption of new 2013 ASCO/CAP guidelines in a single institution: Impact on outcome and cost.
Authors: Sharma Anurag , Hegde Poornima , Vadehra Deepak , Kaiser Talal , Tannenbaum Susan 
Published: September 2018

e18294 Background: Revised guidelines for HER-2 testing in Breast Cancer Specimens occurred in 2007 and again in 2013 with an intention to capture more patients who could benefit from HER-2 directed therapy. Methods: The purpose of this study was to compare the HER 2 + cases outright and the equivocal cases that resulted in a reflex FISH test that was ultimately positive utilizing both guidelines. The number of equivocal tests results and those that ultimately were positive, negative or remained equivocal were quantitated. A retrospective analysis on specimens from 2003-2008 and 2013-2016 was performed. Results: see table. Conclusions: An expansion of 8.8% is seen in the equivocal category after adoption of the 2013 guidelines. Despite an increased number of reflex FISH testing there was no significant increase in the number of FISH positive patients. The end result was a greater delay in time to treat patients appropriately for send-out FISH tests and significant increase in costs for testing that did not result in management change. If the additional costs are multiplied by the number of patients with breast cancer each year and resultant equivocal results calculated for the almost 9% increase, that extra cost is close to 12 million dollars. Based on our small institution study, reconsideration of guideline criteria is important in this era of value-based medicine. [Table: see text]
Measuring cost in the value equation using time-driven activity-based costing (TDABC) at The University of Texas MD Anderson Cancer Center, Division of Radiation Oncology.
Authors: Olivieri Nicholas D. , Frank Benjamin D. , Calhoun John D. , Guzman Alexis B. , Onwenu Justin N. , De La Cerda Isela , Sharma Mallika , Loggenberg Aidan , Shaitelman Simona Flora , Minsky Bruce D. , Jeter Melenda , Ghafar Robert , Feeley Thomas W. , Hahn Stephen M. 
Published: September 2018

e18305 Background: The cost of a full cycle of radiation therapy at MD Anderson Cancer Center has not been determined using a bottom-up measurement approach. Due to the complexity and variation in clinical processes, typical costing strategies do not provide the level of detail necessary to evaluate the value equation, defined as outcomes over cost. To address this limitation, we designed and implemented a practice-wide Time-Driven Activity-Based Costing (TDABC) strategy to capture our total direct cost of care for all treatment modalities within each of 9 disease site-specific services. Methods: Process maps were created for each of the 9 disease site-specific services. Care delivery times were captured by treatment modality for each service as determined by multidisciplinary teams routinely performing each step of the process. The data were entered into a standardized tool, which calculated step costs based upon capacity cost rates for each human resource. The costing tool also calculated total direct labor costs for specific treatment plans based on modality, complexity, and fractionation. Results: The analysis took six months to complete and required the use of approximately 1,000 administrative hours, 250 physician hours, 250 clinical staff hours and 100 medical physics hours. Approximately 17 process maps were created for each of the 9 services with each process map receiving further analysis based upon radiation treatment modality. As a result of observed variation in costs between disease-site services, best practices were identified and 15 standardization opportunities were discovered. Additionally, the cost-benefit analysis between high profile modalities within each disease-site service, such as Proton Therapy and Intensity Modulated Radiation Therapy (IMRT) on the Head and Neck service, were easier to complete. Conclusions: Time-Driven Activity-Based Costing is a valid method for calculating direct costs in a large academic radiation oncology practice. Standardized clinical outcome data can be used to complete the value equation and ultimately provide insight for better clinical and administrative decision making.
Patients’ willingness to pay for blood-based EGFR T790M testing: Results from a Canadian validation study of circulating DNA T790M testing.
Authors: Barnes Tristan Alexandra , Laskin Janessa J. , Cheema Parneet Kaur , Liu Geoffrey , Iqbal Mussawar , Rothenstein Jeffrey , Burkes Ronald L. , Owen Scott Peter , Laurence David , Carvalhana Ilda , Markin Leslie , Wong Linda , Perera-Low Nicole , Sawczak Magdalena , Tsao Ming-Sound , Leighl Natasha B. 
Published: September 2018

e18329 Background: Detection of EGFRmutations in circulating tumor DNA (ctDNA) in peripheral blood has been shown to have high concordance with definitive tumor biopsy samples. Patients’ perceived value and willingness to pay for novel technology can help inform policy and funding decisions in the public healthcare system. Methods: Canadian patients undergoing screening for the ASTRIS clinical trial (NCT02474355) were invited to participate in a national Canadian validation study of blood-based ctDNA T790M testing. All participants had metastatic EGFRmutant lung cancer with acquired resistance to EGFR kinase inhibitors. In addition to collection of blood samples and demographic data, patients completed a structured interview measuring their perceived value of blood-based ctDNA testing as an alternative to tumor biopsy and willingness to pay for testing using both open-ended and iterative bidding approaches. The study was supported by a grant from AstraZeneca. Results: 55 patients have been accrued of a planned 60. As of 01/31/2017, demographic data for 55 and willingness to pay data for 52 patients were available, the rest are pending. The median age of the cohort is 64 years (range 31-87), 68% are Asian (36/53), 56% female (31/55). Patients received a median of 1 prior line of treatment (range 1-7); all received prior EGFR kinase inhibitor therapy (66% gefitinib), and 34% also received prior cytotoxic chemotherapy (18/53). All but one patient preferred to have the blood test over repeat tumor biopsy. Patients were personally willing to pay a median of $400 CAD for the test (IQR $600, range 0-$10000). Patients estimated that a reasonable price for the test was a median of $150 (IQR $300, range 0-$2500). Conclusions: Lung cancer patients value ctDNA testing highly and prefer it to tumor biopsy. Despite the expectation that services like molecular testing should be covered through the Canadian public healthcare system, patients expressed willingness to pay out of pocket for ctDNA blood testing, reflecting perceived major value of this technology.
Cost effectiveness of treating endemic Burkitt lymphoma in Uganda.
Authors: Denburg Avram 
Published: September 2018

e18339 Background: Despite high cure rates achieved in high-income countries, outcomes for children with Burkitt lymphoma (BL) in most low- and middle-income countries (LMICs) remain suboptimal. Perceptions of high cost and resource intensity remain political barriers to the prioritization of BL and other childhood cancer treatment programs in many LMIC health systems. Little to no knowledge exists of the actual cost and cost-effectiveness of treating paediatric cancers in LMICs. To improve outcomes for children with BL, the Uganda Cancer Institute implemented a comprehensive BL treatment program in 2012. Drawing on centralized patient-level data, we undertook an economic evaluation of the program to ascertain the cost-effectiveness of BL therapy in a specific LIC setting. Methods: We compared the treatment of BL (local standard) to usual care (no care), in a cohort of 215 patients treated between 2012 and 2015. Costs included direct, indirect healthcare, and indirect patient costs. Our primary measure of effectivenesswas overall survival (OS). Patient outcomes were determined through electronic chart abstraction. The cost per DALY averted was calculated using WHO-CHOICE methodology and compared to standard definitions of cost-effectiveness. Results: The 2-year OS with treatment was 53% (95% CI, 43% to 62%). Nine percent of patients abandoned therapy. The cost per DALY averted in the treatment group was US$78. Cumulative estimate of national DALYs averted through treatment was 11,046 years, and the total national cost of treatment was US$755,216. The ratio of cost per DALY averted to per capita gross domestic product (GDP) was 0.12, reflecting a very cost-effective intervention. Conclusions: This study demonstrates that treating BL with locally tailored protocols is very cost-effective relative to per capita GDP in Uganda. Studies of this kind will furnish crucial evidence to assist policymakers prioritize the allocation of LMIC health system resources among NCDs, including childhood cancer.