bluuebunny/crossref_metadata_2025_split huggingface dataset:
Accreditation of oncology education in low-and- middle income countries: Perspectives of African oncologists.
Authors: Hammad Nazik , Stockley Densie , Caruso Thomas , Hastings Amber 
Published: September 2018

e18213 Background: There is an expansion of postgraduate oncology training programs in LMIC . Locally trained oncologists are expected to deliver high quality care. Accreditation is one of the essential regulatory mechanisms to ensure high-quality education. Accreditation systems are rarely standardized or applied in the majority of LMIC. The purpose of this study is to understand the perspectives of African Oncologists on the role of accreditation and adoption of global standards into oncology training programs Methods: We developed a survey that addressed African Oncologists’ perspectives of the role of accreditation. It included 187 standards from the WFME PGME standards, ACGME-I standards for hematology/oncology, and the Royal College of Physician and Surgeons of Canada medical oncology standards. A 3-point scale was employed for each standard: 1 = not important, 2 = important but not essential, 3 = essential Results: The survey was sent to 79 physicians, 38 responded. 87% agreed that accreditation ensures quality of education. 100% agreed that it should involve an external review. 74% believe that accreditation is feasible in resource-constrained settings. 45% agreed it will not increase emigration of qualified doctors. Data of 22 individuals who completed the survey in its entirety were analyzed for standards. 5 standards received the highest ratings of 3 from all respondents: life-long learning, professionalism and ethical principles, competence in chemotherapy delivery and management of toxicities. One standard (prior internal medicine training) received a low rating of < 2.0. The majority of standards had ratings between 2.6 and 2.94, indicating that African Oncologists believe most standards to be useful. Ratings < 2.6 were related to resource constraints such as having PET scans or exposure to clinical trial patients. Conclusions: Most African oncologists believe that accreditation ensures quality of education. Most of the standards were considered important. This data will be useful for developing and adapting oncology education accreditation standards in resource-constrained settings. Abbreviations: ACGME-I: American Council of Graduate Medical Education-International
Benefits of satellite lab in the reduction of chemotherapy waiting time.
Authors: Bany Hamdan Abdullah Ahmed , Tamani Jesusa Christine , Peethambaran Sheena , Alfayyad Isamme , Erlandez Richard , Abdulkarim Huda Abdullah , Hussein Mona , AlAsiri Mushabbab , AlHarbi Musa 
Published: September 2018

e18218 Background: Oncology patients need to receive their course of treatment in a timely manner. Increasing the efficiency of laboratory testing could potentially improve hospital operations and thus have a positive impact on patient care. One way of doing this is by initiating an installation of a satellite laboratory. The purpose of this study is to determine the advantages of having a satellite laboratory in an oncology unit. Moreover, it shall also try to determine whether the presence of satellite laboratory will help reduce the chemotherapy waiting time of oncology patients. Methods: This study utilized experimental study design in order to analyze and compare Laboratory Turnaround time (TAT) and the chemotherapy waiting time before and after establishment of satellite laboratory. The samples taken as base line data was 150 and compared to samples taken from 2013-2015. The population of this study included patients in Comprehensive Cancer Center of King Fahad Medical City diagnosed with cancer and received chemotherapy regardless of their age and sex. Results: Laboratory Mean TAT decrease significantly from 1 hour and 30 minutes in 2012 to 43 minutes, 43 minutes, and 37 minutes in 2013, 2014 and 2015 respectively. Also chemotherapy Mean waiting time decreased from 2012 base line of 252 to 164 minutes in 2013, 115 minutes in 2014 and 146 minutes in 2015. The chemotherapy waiting time shows a decreasing pattern as the laboratory time decrease from 2013 to 2015. This shows that there is a decrease in the chemotherapy time and turnaround time before and after the intervention. We also have identified that there is a direct relationship between the reduction of turnaround time and chemotherapy waiting time. Conclusions: The need to structure how we deliver patient care specifically to cancer patient is an important drive for quality improvement. Basing on the result of the project and with the increase in patient satisfaction rate, it can be concluded that it is possible to reduce patients’ mean chemotherapy waiting time by applying more efficient process, which is the installation of satellite laboratory.
Development of the joint Children’s Cancer Hospital Egypt (CCHE-57357) Dana-Farber Boston Children’s Hospital Pediatric Oncology Fellowship Program.
Authors: Zamzam Manal , Hafez Hanafy , Khedr Reham , Abouelnaga Sherif , Abdelbaki Mohamed , Lehmann Leslie , Goumnerova Liliana C. , Houlahan Kathleen , Kieran Mark W. , Pruden Patricia 
Published: September 2018

e18226 Background: Children diagnosed with cancer in low- and middle-income countries (LMIC) have markedly inferior outcomes compared to those in high income countries. While some of these issues can be resource availability, a major problem is the quality of training and traditional methods of clinical practice where decision making is centered on the most senior person on the team. To ensure real change, highly-trained locally based specialists with a strong emphasis on problem-solving and critical thinking using evidence-based approaches are needed. Methods: The Children’s Cancer Hospital Egypt (CCHE-57357) and Dana-Farber Boston Children’s Hospital (DFBCH) at Harvard Medical School developed a 30 month pediatric oncology fellowship training program following the American Academy of Pediatrics fellowship guidelines. The primary objective of the program was to implement a shared education model to develop highly educated physicians who are able to follow evidence-based approaches and who are committed to sustained practice in LMIC. Results: DFBCH staff provide ongoing education to the fellows through visits to CCHE-57357 every 2-3 months, weekly video sessions with the fellows for case presentation and journal clubs, and weekly conference calls with the fellowship program staff to ensure that the goals and objectives for each fellow and the program are met. Each of the current 15 fellows spend 6 weeks/year in Boston participating in evidence-based multi-disciplinary based rounds; the remainder of the curriculum takes place at CCHE-57357 and incorporates an array of individual, small group and e-learning modules specifically created for the program. Three classes of fellows have been enrolled and the senior class will graduate in the spring of 2017. Conclusions: Training of fellows following the same standards and methods as those applied to North American candidates is feasible and has the potential to advance the quality of education and expertise in LMIC. By focusing on the education of the next generation of clinicians, the opportunity to implement many of the important principles of clinical care can be realized.
Identifying and understanding how to address the gaps in care experienced by adolescent and young adult cancer patients at UIHC.
Authors: Mobley Erin Michele , Foster Kristin , Terry William W. 
Published: September 2018

e18238 Background: Cancer survival rates for adolescents and young adults (AYAs) have not improved at the same rate as other age groups. According to the National Cancer Institute, these patients may fall into a gap between pediatric and adult practices. In an effort to counteract the decreased survival rates of AYAs, the Stead Family Children’s Hospital and the Holden Comprehensive Cancer Center joined forces to develop an AYA cancer program at the University of Iowa Hospitals and Clinics. Methods: The target population included patients aged 13-31 treated for malignancy in one of the following diseases or disease sites: central nervous system, leukemia, lymphoma, neuroendocrine, sarcoma, thyroid, and other. Four focus groups were held to identify and describe gaps in care, as well as provide suggestions for program development. A convergent-parallel mixed-methods design was used. Qualitative data were derived from focus group discussion and selected free-response survey questions, while quantitative data were derived from objective survey questions. Both quantitative and qualitative analyses were conducted to gain targeted feedback from participants. Results: Across the four focus groups, the number of participants ranged from 8 – 19 (n = 24). Topics discussed included: communication, treatment experience, overall AYA program; finances, work, school, late effects; relationships, emotions, spirituality; and body image, infertility, sexuality, risky behavior, and suicide. The results of the analyses found three unique domains that are important to AYAs across the cancer continuum: autonomy, communication, and relationships. The three primary domains make the AYA population different from traditional adult or pediatric populations. The surveys corroborated the focus group discussion findings. Conclusions: Information obtained from these analyses have been used to inform specific projects within the development of the AYA program to address patient-identified gaps. For AYAs, the importance of autonomy, communication, and relationships should be considered when developing an AYA program, as well as for potential policy or health services research utilization in the future.
Pilot analysis exploring the potential value of an integrated electronic patient reported outcome (PRO) application specifically designed for use in oncology practice.
Authors: Hopkins Thomas 
Published: September 2018

e18246 Background: PROs may soon be used as indicators of the quality of care provided and to support comparative effectiveness research (CER). Many oncology practices are developing tools to deploy PRO tools electronically to improve effectiveness of data capture, enhance the clinical utility of the data for providers and integrate PRO data with local and national registries. Here we describe our preliminary experience with developing software for this purpose. Methods: We created a software application and a HIPAA compliant cloud-based data architecture to obtain, store, clean and normalize PRO data and infusion system data needed to define, create, measure and analyze clinical and operational key performance indicators, which are then integrated into reports and displayed to end-users on a dashboard in an actionable format. The application supports efficient data collection and interfaces with patients via secure text message or email link. The dashboard component of the application is a legible, single-page, real-time interface, depicting a tabular and graphical presentation of current and historical key performance indicators that enable instantaneous and informed decisions. Results: Figure I depicts the application patient demographics page, which allows clinicians and clinical support staff to enter patient data and enroll the patient in customized templates, which allow flexible delivery of content on a customized predetermined timeline. Figure II illustrates the PRO patient-facing interface, as displayed on a mobile device. Figure III illustrates the analytics function of the application, which displays patient-specific summary or population aggregate data and has the capacity to combine PRO data with objective data obtained from infusion systems. Conclusions: In this abstract, we describe our experience with creating an application that will collect and deliver accurate, reliable and ultimately actionable clinical and operational data to clinicians and operational leaders in oncology practices. The application is currently being evaluated for clinical and research use at our institution.
Importance of pharmacist intervention in preventing adverse drug events after chemotherapy infusion.
Authors: Gambôa Nathalia , Maia João Raphael 
Published: September 2018

e18256 Background: The importance of monitoring Adverse Drug Reactions (ADRs) is undeniable, because it may limit the therapy and lead to stop a cancer treatment. Early identification and appropriate clinical management, prior to after chemotherapy, may mitigate or reverse undesirable effects. Effective Pharmacovigilance occurs through active participation and assertive communication among health professionals. In this context, the present work is aimed at quantifying Pharmaceutical Interventions after ADR and its impact on therapy. Methods: The data collection was done by analysis of the Nursing Evolutions on the ADR presented during infusion. After identifying them, the Clinical Pharmacist investigates and suggests interventions in a pre-chemotherapy scheme to the Oncologist, if pertinent. Work performed between April 2016 and January 2017, at a private Oncology Clinic in Rio de Janeiro, Brazil. Results: During the period, 60 pharmaceutical interventions were performed on prescriptions of patients who presented adverse drug reactions. Of these, 40 patients (67%) did not present the same reaction again and 20 patients (33%) presented it again, despite the change in pre-chemotherapy. The most common reactions were hypersensitivity (47%) and abdominal colic (43%). The most commonly prescribed drugs were hydrocortisone (22%), diphenhydramine (25%) and atropine (40%). Conclusions: These findings reaffirm pharmacovigilance as an important multidisciplinary instrument to promote the safe use of drugs, the efficacy of cancer treatment and the improve of quality of life in cancer patients. This importance is strengthened in the oncology clinic, in which patients are more likely to present possible ADR due to the frequent use of multidrug therapy.
Justification for deployment of peripherally inserted central catheter (PICC).
Authors: Maia João Raphael , Torrecillas Flavia , Borella Marcio 
Published: September 2018

e18257 Background: Is not practical in countries of Latin America the use of Central Venous Catheters - CL in Oncology due the difficulty of financing of this procedure. The PICC is a vascular access device inserted in peripheral vein infusion drugs with Center for a cost of no more than 20% when compared to use of a catheter fully deployed. Methods: We conducted a cross-sectional study, retrospective and quantitative data were collected from complication and pharmacovigilance of a private oncology outpatient clinic in Rio de Janeiro, in the care of patients undergoing treatment for breast cancer with Paclitaxel weekly in the Jan 2016 period the Dec 2016. Results: The study were performed with 98 patients, peripheral venous access 75.5% and 24.5% central venous access. Of patients with peripheral venous access, 47.3% had exclusive member to puncture. Of this group, 21.6% of patients achieved success on first CL in all infusions performed in the period and 78.4% needed more than one CL for Administration of paclitaxel in at least an infusion. 182 Pharmacovigilance notifications were made, being 38.5% for the flebogênicidade symptoms after use of paclitaxel. Conclusions: The study highlights the relationship between venous access safe and successful outpatient antineoplasic therapy. The data observed in analyzed period justifies the creation of deployment Protocol of PICC for patients with breast cancer to treatment with Paclitaxel weekly. It is hoped with this Protocol added convenience and safety for the patient, ensuring fast start of infusional therapy often delayed by the difficulty in accessing the patient's venous network, reducing and avoiding delays in cycles, with low rates of complications for the same and lower costs.
Leading the way: The National Cancer Institute’s (NCI) single IRB for multi-site research.
Authors: Massett Holly A. , Goldberg Jacqueline , Hampp Sharon , Mooney Margaret M. , Campbell Brian , Narasimhaswamy Suma , Mishkin Grace , Rajaram Ravi , Covington Laura , Montello Michael , Denicoff Andrea , Kruhm Martha , Abrams Jeffrey S. 
Published: September 2018

e18259 Background: NCI instituted a Central IRB (CIRB) with voluntary participation in 2001 for its late-phase trials and demonstrated that efficiency could be improved and costs reduced (Wagner et al JCO, 2010; 28). As a forerunner to the new NIH policy for single IRBs for all NIH multi-site trials (Hudson et al. JAMA Oct 4, 2010), NCI implemented a new CIRB model in 2014 where the CIRB was the IRB of record. We report adoption data of the new model within NCI’s National Clinical Trials Network (NCTN) and lessons learned from the rollout. Methods: We reviewed: Annual CIRB participant data from 2013-2016; site/accrual data for late phase trials activated between 2013-2016 (N = 64) via CIRB or local IRBs; and data from CIRB reports to identify acceptance and lessons learned. We compared time required for CIRB protocol reviews via the new model to baseline measures in the literature. Results: Of the 2,300 U.S. NCTN sites, the percentage of participation went from 47% in 2013, to 74% (2014), 79% (2015), and 81% (2016). For activated trials, a median of 43% of sites used their local IRB in 2013, dropping to 18% in 2014, 5% in 2015, and only 1% in 2016; i.e., 99% of sites opening trials in 2016 did so using the CIRB. Annual accrual to NCTN trials remained steady through the CIRB adoption; CIRB sites represented a median of 56% of total accrual in 2013 increasing to 87% in 2016. Help-desk and survey data indicate increased acceptance and a reduction of concerns over the 3 years. Previous analyses prior to 2013 reported a median of 70-123 days required from protocol application receipt to final CIRB approval; the new model reports a median of 41 days in 2016. Conclusions: NCI has demonstrated that a single IRB for multi-site trials is not only viable but valuable. Its new CIRB model rollout over 3 years has resulted in a doubling of site adoption, high utilization rates, further efficiencies, and overall acceptance, with no noticeable effect on overall NCTN accrual. Our experiences provide important lessons learned and insights into the successful implementation of a single IRB at a national level, and support the feasibility of NIH’s recently finalized policy requiring all sites to use a single IRB for multi-site research.
Adherence to 'Choosing Wisely' recommendations for radiation therapy in a commercially insured breast cancer population.
Authors: Roth Joshua A. , McDougall Jean A. , Halasz Lia Moriguchi , Fedorenko Catherine R. , Sun Qin , Goulart Bernardo H. L. , Patel Shilpen A. 
Published: September 2018

e18267 Background: ASTRO ‘Choosing Wisely recommendations’ (CWr) note radiation therapy (RT) interventions lacking evidence of benefit in cancer care. This study evaluates adherence to the 2013 CWr to ‘not routinely use intensity modulated radiotherapy (IMRT) to deliver whole breast radiotherapy as part of breast conservation therapy’ using a novel linkage between the Western WA Cancer Surveillance System (CSS) and claims from two large commercial insurance plans. No studies have evaluated adherence to this CWr in a commercial insurance setting. Methods: CSS records for first primary Stage I/II breast cancer cases (2008-2015) were linked with Premera Blue Cross and Regence Blue Shield claims. Included cases had coverage for ≥12-months before/after diagnosis (or until death), lumpectomy within 6 months of diagnosis, and RT within 6 months of lumpectomy. We used generalized estimating equations (GEE) to evaluate associations between demographic (age, race) and tumor (grade, laterality, diagnosis year) variables and use of IMRT vs conventional conformal RT within 1 year of diagnosis. Results: We identified 1,048 first primary Stage I/II breast cancer cases that met inclusion criteria. Mean age was 61, 91% were white, 52% were left-side cases. The non-adherent proportions are in the table below. In GEE analysis, only left-side cases (OR=6.4, p<0.001) and years of age (OR=1.03, p<0.01) were independently associated with IMRT use. Conclusions: Patients with IMRT vs. conventional conformal RT after lumpectomy may incur additional cost without commensurate clinical benefit. In the first study of adherence to a CWr against IMRT in this setting, we found that left-side cases were 6-fold more likely to be non-adherent vs right-side cases. This association suggests that IMRT is being used to reduce radiation dose to the heart, though not supported by evidence. Overall, the small non-adherent proportion before/after the CWr suggests alignment between guidelines and use of IMRT in Western WA. Future studies should evaluate IMRT use in other regions and develop strategies to improve CWr adherence in left-side cases. [Table: see text]
Faster approvals?: Trends in the use of FDA’s expedited approval programs for oncology medications.
Authors: Vadola Lisa Ambrosini , Pond Monique A , Winter-Vann Ann , Whitsell Robin 
Published: September 2018

e18270 Background: With the importance of speed-to-market and addressing unmet needs, pharmaceutical companies have sought accelerated approvals through the Food and Drug Administration (FDA). Introduced with the FDA Safety and Innovation Act (FDASIA) of 2012, Breakthrough Therapy Designation (BTD) has become an important mechanism for approval of serious and life-threatening conditions that do not have adequate therapies. Notably, these pathways have been ill-understood by both pharmaceutical companies and health care providers. This study assessed how BTD and other FDA designations have played a role in the approval of oncology drug marketing applications and evaluated trends in the use of these regulatory pathways. Methods: We analyzed publicly available data on novel oncology drug approvals by the FDA from 2012-2016, including the 4 expedited programs for serious conditions (BTD, Accelerated Approval, Fast Track, and Priority Review). Results: Of the 43 novel oncology drugs approved by the FDA between 2012-2016, 42 used at least 1 of the expedited approval programs, including 65% that used ≥2 programs and 35% that used ≥3 programs. The BTD has been used by 15 of the 43 (35%) approved novel oncology drugs since 2012. The use of the BTD, Accelerated Approval pathway, and Priority Review designation among approved oncology drugs has generally increased each year from 2012-2016, while the use of the Fast Track designation has decreased over the same time period. Conclusions: Companies seeking oncology approvals often use more than one expediting strategy. Alone or in combinations, the BTD, Accelerated Approval, and Priority Review have been shown to play an increasingly important role in oncology drug development. Data collected between 2012-2016 suggest that use of BTD is growing more common, while use of the Fast Track designation has decreased among approved oncology drugs. Additional expedited approval programs have remained steady or increased since the FDA introduced BTD. Based on these observations, we anticipate use of the BTD, Accelerated Approval, and Priority Review designation will grow in future oncology drug applications.