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  1 / 15043 MEDLINE  
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PMID:29191895
Autor:Eisenberg R; Varmus H
Endereço:University of Michigan Law School, Ann Arbor, MI 48109, USA. rse@umich.edu varmus@med.cornell.edu.
Título:Insurance for broad genomic tests in oncology.
Fonte:Science; 358(6367):1133-1134, 2017 12 01.
ISSN:1095-9203
País de publicação:United States
Idioma:eng
Tipo de publicação: JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T


  2 / 15043 MEDLINE  
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PMID:28743680
Autor:Micheel CM; Anderson IA; Lee P; Chen SC; Justiss K; Giuse NB; Ye F; Kusnoor SV; Levy MA
Endereço:Division of Hematology and Oncology, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, United States.
Título:Internet-Based Assessment of Oncology Health Care Professional Learning Style and Optimization of Materials for Web-Based Learning: Controlled Trial With Concealed Allocation.
Fonte:J Med Internet Res; 19(7):e265, 2017 Jul 25.
ISSN:1438-8871
País de publicação:Canada
Idioma:eng
Resumo:BACKGROUND: Precision medicine has resulted in increasing complexity in the treatment of cancer. Web-based educational materials can help address the needs of oncology health care professionals seeking to understand up-to-date treatment strategies. OBJECTIVE: This study aimed to assess learning styles of oncology health care professionals and to determine whether learning style-tailored educational materials lead to enhanced learning. METHODS: In all, 21,465 oncology health care professionals were invited by email to participate in the fully automated, parallel group study. Enrollment and follow-up occurred between July 13 and September 7, 2015. Self-enrolled participants took a learning style survey and were assigned to the intervention or control arm using concealed alternating allocation. Participants in the intervention group viewed educational materials consistent with their preferences for learning (reading, listening, and/or watching); participants in the control group viewed educational materials typical of the My Cancer Genome website. Educational materials covered the topic of treatment of metastatic estrogen receptor-positive (ER+) breast cancer using cyclin-dependent kinases 4/6 (CDK4/6) inhibitors. Participant knowledge was assessed immediately before (pretest), immediately after (posttest), and 2 weeks after (follow-up test) review of the educational materials. Study statisticians were blinded to group assignment. RESULTS: A total of 751 participants enrolled in the study. Of these, 367 (48.9%) were allocated to the intervention arm and 384 (51.1%) were allocated to the control arm. Of those allocated to the intervention arm, 256 (69.8%) completed all assessments. Of those allocated to the control arm, 296 (77.1%) completed all assessments. An additional 12 participants were deemed ineligible and one withdrew. Of the 552 participants, 438 (79.3%) self-identified as multimodal learners. The intervention arm showed greater improvement in posttest score compared to the control group (0.4 points or 4.0% more improvement on average; P=.004) and a higher follow-up test score than the control group (0.3 points or 3.3% more improvement on average; P=.02). CONCLUSIONS: Although the study demonstrated more learning with learning style-tailored educational materials, the magnitude of increased learning and the largely multimodal learning styles preferred by the study participants lead us to conclude that future content-creation efforts should focus on multimodal educational materials rather than learning style-tailored content.
Tipo de publicação: JOURNAL ARTICLE


  3 / 15043 MEDLINE  
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PMID:28746860
Autor:Rogawski DS; Vitanza NA; Gauthier AC; Ramaswamy V; Koschmann C
Endereço:Department of Pediatrics, University of Michigan School of Medicine, Ann Arbor, Mich.
Título:Integrating RNA sequencing into neuro-oncology practice.
Fonte:Transl Res; 189:93-104, 2017 Nov.
ISSN:1878-1810
País de publicação:United States
Idioma:eng
Resumo:Malignant tumors of the central nervous system (CNS) cause substantial morbidity and mortality, yet efforts to optimize chemo- and radiotherapy have largely failed to improve dismal prognoses. Over the past decade, RNA sequencing (RNA-seq) has emerged as a powerful tool to comprehensively characterize the transcriptome of CNS tumor cells in one high-throughput step, leading to improved understanding of CNS tumor biology and suggesting new routes for targeted therapies. RNA-seq has been instrumental in improving the diagnostic classification of brain tumors, characterizing oncogenic fusion genes, and shedding light on intratumor heterogeneity. Currently, RNA-seq is beginning to be incorporated into regular neuro-oncology practice in the form of precision neuro-oncology programs, which use information from tumor sequencing to guide implementation of personalized targeted therapies. These programs show great promise in improving patient outcomes for tumors where single agent trials have been ineffective. As RNA-seq is a relatively new technique, many further applications yielding new advances in CNS tumor research and management are expected in the coming years.
Tipo de publicação: JOURNAL ARTICLE; REVIEW


  4 / 15043 MEDLINE  
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Chammas, R
Texto completo SciELO Brasil
PMID:29340530
Autor:Fernandes GS; Sternberg C; Lopes G; Chammas R; Gifoni MAC; Gil RA; Araujo DV
Endereço:Sociedade Brasileira de Oncologia Clínica, Hospital Sírio-Libanês, São Paulo, SP, Brasil.
Título:The use of biosimilar medicines in oncology - position statement of the Brazilian Society of Clinical Oncology (SBOC).
Fonte:Braz J Med Biol Res; 51(3):e7214, 2018 Jan 11.
ISSN:1414-431X
País de publicação:Brazil
Idioma:eng
Resumo:A biosimilar is a biologic product that is similar to a reference biopharmaceutical product, the manufacturing process of which hinders the ability to identically replicate the structure of the original product, and therefore, it cannot be described as an absolute equivalent of the original medication. The currently available technology does not allow for an accurate copy of complex molecules, but it does allow the replication of similar molecules with the same activity. As biosimilars are about to be introduced in oncology practice, these must be evaluated through evidence-based medicine. This manuscript is a position paper, where the Brazilian Society of Clinical Oncology (SBOC) aims to describe pertinent issues regarding the approval and use of biosimilars in oncology. As a working group on behalf of SBOC, we discuss aspects related to definition, labeling/nomenclature, extrapolation, interchangeability, switching, automatic substitution, clinical standards on safety and efficacy, and the potential impact on financial burden in healthcare. We take a stand in favor of the introduction of biosimilars, as they offer a viable, safe, and cost-effective alternative to the biopharmaceutical products currently used in cancer. We hope this document can provide valuable information to support therapeutic decisions that maximize the clinical benefit for the thousands of cancer patients in Brazil and can contribute to expedite the introduction of this new drug class in clinical practice. We expect the conveyed information to serve as a basis for further discussion in Latin America, this being the first position paper issued by a Latin American Oncology Society.
Tipo de publicação: JOURNAL ARTICLE
Nome de substância:0 (Antibodies, Monoclonal); 0 (Biosimilar Pharmaceuticals)


  5 / 15043 MEDLINE  
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PMID:29397917
Autor:Lejeune C; Lueza B; Bonastre J; le French costing group
Endereço:Université Bourgogne Franche-Comté-Inserm CIC1432, module épidémiologie clinique, 7, boulevard Jeanne-d'Arc, 21000 Dijon, France; Centre hospitalier universitaire, centre d'investigation clinique, module épidémiologie clinique/essais cliniques, 7, boulevard Jeanne-d'Arc, BP 87900, 21000 Dijon, France; Université de Bourgogne et Franche-Comté, EPICAD LNC-UMR1231, 7, boulevard Jeanne-d'Arc, BP 87900, 21000 Dijon, France. Electronic address: catherine.lejeune@u-bourgogne.fr.
Título:[Economic analysis of multinational clinical trials in oncology].
Título:Analyse économique des essais cliniques internationaux en cancérologie..
Fonte:Bull Cancer; 105(2):204-211, 2018 Feb.
ISSN:1769-6917
País de publicação:France
Idioma:fre
Resumo:In oncology, as in other fields of medicine, international multicentre clinical trials came into being so as to include a sufficient number of subjects to investigate a clinical situation. The existence of tight budgetary constraints and the desire to make the best use of the resources available have resulted in the development of economic evaluations associated with these trials, which, thanks to their level of evidence and their size, provide particularly relevant material. Nonetheless, economic evaluations alongside international clinical trials raise specific questions of methodology with regard to both the design and the analysis of the results. Indeed, the costs of goods and services consumed, the types and quantities of resources, and medical practices vary from one country to another and within an individual country. Economic data from the different countries involved must be available so as to study and to take into account this variability, and appropriate techniques for cost estimations and analysis must be implemented to aggregate the results from several countries. From a review of the literature, the aim of this work was to provide an overview of the specific methodological features of economic evaluations alongside international clinical trials: analysis of efficacy data from several countries, collection of resources and real costs, methods to establish the monetary value of resources, methods to aggregate results accounting for the trial effect.
Tipo de publicação: JOURNAL ARTICLE; REVIEW


  6 / 15043 MEDLINE  
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PMID:29390340
Autor:Zhu X; Zhou X; Zhang Y; Sun X; Liu H; Zhang Y
Endereço:Public Health College, Qingdao University, Qingdao, China.
Título:Reporting and methodological quality of survival analysis in articles published in Chinese oncology journals.
Fonte:Medicine (Baltimore); 96(50):e9204, 2017 Dec.
ISSN:1536-5964
País de publicação:United States
Idioma:eng
Resumo:Survival analysis methods have gained widespread use in the filed of oncology. For achievement of reliable results, the methodological process and report quality is crucial. This review provides the first examination of methodological characteristics and reporting quality of survival analysis in articles published in leading Chinese oncology journals.To examine methodological and reporting quality of survival analysis, to identify some common deficiencies, to desirable precautions in the analysis, and relate advice for authors, readers, and editors.A total of 242 survival analysis articles were included to be evaluated from 1492 articles published in 4 leading Chinese oncology journals in 2013. Articles were evaluated according to 16 established items for proper use and reporting of survival analysis.The application rates of Kaplan-Meier, life table, log-rank test, Breslow test, and Cox proportional hazards model (Cox model) were 91.74%, 3.72%, 78.51%, 0.41%, and 46.28%, respectively, no article used the parametric method for survival analysis. Multivariate Cox model was conducted in 112 articles (46.28%). Follow-up rates were mentioned in 155 articles (64.05%), of which 4 articles were under 80% and the lowest was 75.25%, 55 articles were100%. The report rates of all types of survival endpoint were lower than 10%. Eleven of 100 articles which reported a loss to follow-up had stated how to treat it in the analysis. One hundred thirty articles (53.72%) did not perform multivariate analysis. One hundred thirty-nine articles (57.44%) did not define the survival time. Violations and omissions of methodological guidelines included no mention of pertinent checks for proportional hazard assumption; no report of testing for interactions and collinearity between independent variables; no report of calculation method of sample size. Thirty-six articles (32.74%) reported the methods of independent variable selection. The above defects could make potentially inaccurate, misleading of the reported results, or difficult to interpret.There are gaps in the conduct and reporting of survival analysis in studies published in Chinese oncology journals, severe deficiencies were noted. More endorsement by journals of the report guideline for survival analysis may improve articles quality, and the dissemination of reliable evidence to oncology clinicians. We recommend authors, readers, reviewers, and editors to consider survival analysis more carefully and cooperate more closely with statisticians and epidemiologists.
Tipo de publicação: JOURNAL ARTICLE


  7 / 15043 MEDLINE  
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PMID:29172678
Autor:Sharma RA; Fumi L; Audisio RA; Denys A; Wood BJ; Pignatti F
Endereço:1 Department of Oncology, NIHR Oxford Biomedical Research Centre, University of Oxford , Oxford , UK.
Título:Commentary: how will interventional oncology navigate the "valleys of death" for new medical devices?
Fonte:Br J Radiol; 91(1083):20170643, 2018 Feb.
ISSN:1748-880X
País de publicação:England
Idioma:eng
Resumo:Whereas clinical trials of cancer drugs have methodological standards and conventional primary endpoints, these are not necessarily applicable to the clinical development of loco-regional treatments and new medical devices. The current challenge is to generate high-level clinical evidence for loco-regional treatments to define the benefits for patients. In this article, we argue that, to generate convincing evidence of clinical efficacy and safety, the collective coherence of the entire data package is often more important than the primary endpoint of one clinical trial. We also propose that, when a comprehensive clinical data package is not feasible, limited clinical data can be supplemented with other types of evidence. Emerging life science companies often define the "valley of death" after securing initial investment to translate an early medical device concept to a development stage that is attractive to funders. Unfortunately for this industry, there is a second "valley of death" if the focus and goal is only regulatory approval, to the neglect of clinical acceptance and reimbursement. For the emerging specialism of interventional oncology, it is critical to plan a clear line of sight for each new medical device to avoid the valleys of death and to demonstrate the clinical benefit. Increased international guidance to establish realistic yet convincing standards in this area may avoid attrition of potentially beneficial devices and therapeutic procedures in the valleys of death.
Tipo de publicação: JOURNAL ARTICLE


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PMID:27776833
Autor:Miaskowski C
Título:Future Directions in Symptom Cluster Research.
Fonte:Semin Oncol Nurs; 32(4):405-415, 2016 11.
ISSN:1878-3449
País de publicação:United States
Idioma:eng
Resumo:OBJECTIVES: To consider future directions for symptom cluster research. These considerations are organized using the two main conceptual approaches for symptom cluster research (ie, "de novo" identification of symptom clusters, and identification of subgroups of patients with distinct symptom experiences with a prespecified symptom cluster). DATA SOURCES: Peer-reviewed journals and guidelines from professional organizations. CONCLUSION: Research on symptom clusters in oncology patients is growing at an exponential rate. However, numerous studies are needed to increase the growth of symptom management research. IMPLICATIONS FOR NURSING PRACTICE: Findings from this area of symptom management science have the potential to improve the management of multiple co-occurring symptoms in oncology patients. In addition, mechanistic-based studies hold great promise to identify new biological and behavioral targets that will form the basis for subsequent intervention studies.
Tipo de publicação: JOURNAL ARTICLE; REVIEW


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PMID:29285944
Autor:Horváth B
Título:[Sándor Miksa Kocsis MD who established the first Oncology Department out of Budapest (Hungary), was born one hundred years ago].
Título:Száz éve született dr. Kocsis Sándor Miksa, az elso "vidéki" onkológiai osztály alapító foorvosa..
Fonte:Orv Hetil; 158(52):2087-2088, 2017 Dec.
ISSN:0030-6002
País de publicação:Hungary
Idioma:hun
Tipo de publicação: BIOGRAPHY; HISTORICAL ARTICLE; JOURNAL ARTICLE
Nome de pessoa como assunto: Kocsis SM


  10 / 15043 MEDLINE  
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PMID:29365282
Autor:Desai S; McWilliams JM
Endereço:From the Department of Population Health, New York University, New York (S.D.); and the Department of Health Care Policy, Harvard Medical School (S.D., J.M.M.), and the Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital (J.M.M.) - both in Boston.
Título:Consequences of the 340B Drug Pricing Program.
Fonte:N Engl J Med; 378(6):539-548, 2018 02 08.
ISSN:1533-4406
País de publicação:United States
Idioma:eng
Resumo:BACKGROUND: The 340B Drug Pricing Program entitles qualifying hospitals to discounts on outpatient drugs, increasing the profitability of drug administration. By tying the program eligibility of hospitals to their Disproportionate Share Hospital (DSH) adjustment percentage, which reflects the proportion of hospitalized patients who are low-income, the program is intended to expand resources for underserved populations but provides no direct incentives for hospitals to use financial gains to enhance care for low-income patients. METHODS: We used Medicare claims and a regression-discontinuity design, taking advantage of the threshold for program eligibility among general acute care hospitals (DSH percentage, >11.75%), to isolate the effects of the program on hospital-physician consolidation (i.e., acquisition of physician practices or employment of physicians by hospitals) and on the outpatient administration of parenteral drugs by hospital-owned facilities in three specialties in which parenteral drugs are frequently used. For low-income patients, we also assessed the effects of the program on the provision of care by hospitals and on mortality. RESULTS: Hospital eligibility for the 340B Program was associated with 2.3 more hematologist-oncologists practicing in facilities owned by the hospital, or 230% more hematologist-oncologists than expected in the absence of the program (P=0.02), and with 0.9 (or 900%) more ophthalmologists per hospital (P=0.08) and 0.1 (or 33%) more rheumatologists per hospital (P=0.84). Program eligibility was associated with significantly higher numbers of parenteral drug claims billed by hospitals for Medicare patients in hematology-oncology (90% higher, P=0.001) and ophthalmology (177% higher, P=0.03) but not rheumatology (77% higher, P=0.12). Program eligibility was associated with lower proportions of low-income patients in hematology-oncology and ophthalmology and with no significant differences in hospital provision of safety-net or inpatient care for low-income groups or in mortality among low-income residents of the hospitals' local service areas. CONCLUSIONS: The 340B Program has been associated with hospital-physician consolidation in hematology-oncology and with more hospital-based administration of parenteral drugs in hematology-oncology and ophthalmology. Financial gains for hospitals have not been associated with clear evidence of expanded care or lower mortality among low-income patients. (Funded by the Agency for Healthcare Research and Quality and others.).
Tipo de publicação: JOURNAL ARTICLE; RESEARCH SUPPORT, N.I.H., EXTRAMURAL; RESEARCH SUPPORT, NON-U.S. GOV'T



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