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Showing papers by "Mayo Clinic published in 2017"


Journal ArticleDOI
TL;DR: The Global Burden of Diseases, Injuries, and Risk Factors Study 2016 (GBD 2016) provides a comprehensive assessment of prevalence, incidence, and years lived with disability (YLDs) for 328 causes in 195 countries and territories from 1990 to 2016.

10,401 citations


Journal ArticleDOI
TL;DR: The 2017 McDonald criteria continue to apply primarily to patients experiencing a typical clinically isolated syndrome, define what is needed to fulfil dissemination in time and space of lesions in the CNS, and stress the need for no better explanation for the presentation.
Abstract: The 2010 McDonald criteria for the diagnosis of multiple sclerosis are widely used in research and clinical practice. Scientific advances in the past 7 years suggest that they might no longer provide the most up-to-date guidance for clinicians and researchers. The International Panel on Diagnosis of Multiple Sclerosis reviewed the 2010 McDonald criteria and recommended revisions. The 2017 McDonald criteria continue to apply primarily to patients experiencing a typical clinically isolated syndrome, define what is needed to fulfil dissemination in time and space of lesions in the CNS, and stress the need for no better explanation for the presentation. The following changes were made: in patients with a typical clinically isolated syndrome and clinical or MRI demonstration of dissemination in space, the presence of CSF-specific oligoclonal bands allows a diagnosis of multiple sclerosis; symptomatic lesions can be used to demonstrate dissemination in space or time in patients with supratentorial, infratentorial, or spinal cord syndrome; and cortical lesions can be used to demonstrate dissemination in space. Research to further refine the criteria should focus on optic nerve involvement, validation in diverse populations, and incorporation of advanced imaging, neurophysiological, and body fluid markers.

3,945 citations


Journal ArticleDOI
TL;DR: Patients with refractory large B‐cell lymphoma who received CAR T‐cell therapy with axi‐cel had high levels of durable response, with a safety profile that included myelosuppression, the cytokine release syndrome, and neurologic events.
Abstract: BackgroundIn a phase 1 trial, axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, showed efficacy in patients with refractory large B-cell lymphoma after the failure of conventional therapy. MethodsIn this multicenter, phase 2 trial, we enrolled 111 patients with diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, or transformed follicular lymphoma who had refractory disease despite undergoing recommended prior therapy. Patients received a target dose of 2×106 anti-CD19 CAR T cells per kilogram of body weight after receiving a conditioning regimen of low-dose cyclophosphamide and fludarabine. The primary end point was the rate of objective response (calculated as the combined rates of complete response and partial response). Secondary end points included overall survival, safety, and biomarker assessments. ResultsAmong the 111 patients who were enrolled, axi-cel was successfully manufactured for 110 (99%) and administered to 101 (91%)....

3,363 citations


Journal ArticleDOI
TL;DR: The authors highlight the overall organizational and structural changes as well as “what's new” in the Eighth Edition of the AJCC Cancer Staging Manual.
Abstract: The American Joint Committee on Cancer (AJCC) staging manual has become the benchmark for classifying patients with cancer, defining prognosis, and determining the best treatment approaches. Many view the primary role of the tumor, lymph node, metastasis (TNM) system as that of a standardized classification system for evaluating cancer at a population level in terms of the extent of disease, both at initial presentation and after surgical treatment, and the overall impact of improvements in cancer treatment. The rapid evolution of knowledge in cancer biology and the discovery and validation of biologic factors that predict cancer outcome and response to treatment with better accuracy have led some cancer experts to question the utility of a TNM-based approach in clinical care at an individualized patient level. In the Eighth Edition of the AJCC Cancer Staging Manual, the goal of including relevant, nonanatomic (including molecular) factors has been foremost, although changes are made only when there is strong evidence for inclusion. The editorial board viewed this iteration as a proactive effort to continue to build the important bridge from a "population-based" to a more "personalized" approach to patient classification, one that forms the conceptual framework and foundation of cancer staging in the era of precision molecular oncology. The AJCC promulgates best staging practices through each new edition in an effort to provide cancer care providers with a powerful, knowledge-based resource for the battle against cancer. In this commentary, the authors highlight the overall organizational and structural changes as well as "what's new" in the Eighth Edition. It is hoped that this information will provide the reader with a better understanding of the rationale behind the aggregate proposed changes and the exciting developments in the upcoming edition. CA Cancer J Clin 2017;67:93-99. © 2017 American Cancer Society.

3,362 citations


Journal ArticleDOI
Ian G. McKeith, Bradley F. Boeve, Dennis W. Dickson, Glenda M. Halliday, John-Paul Taylor1, Daniel Weintraub2, Dag Aarsland3, Dag Aarsland1, James E. Galvin2, Johannes Attems4, Johannes Attems5, Clive Ballard2, Clive Ballard5, Ashley Bayston2, Ashley Bayston5, Thomas G. Beach6, Thomas G. Beach1, Frédéric Blanc7, Nicolaas Bohnen8, Nicolaas Bohnen9, Nicolaas Bohnen10, Laura Bonanni3, Laura Bonanni1, Jose Bras1, Jose Bras3, Patrik Brundin1, Patrik Brundin3, David J. Burn1, David J. Burn3, Alice Chen-Plotkin3, John E. Duda11, Omar M. A. El-Agnaf, Howard Feldman12, Tanis J. Ferman, Dominic Ffytche13, Hiroshige Fujishiro14, Douglas Galasko15, Jennifer G. Goldman16, Stephen N. Gomperts16, Neill R. Graff-Radford, Lawrence S. Honig17, Lawrence S. Honig18, Alex Iranzo19, Alex Iranzo20, Alex Iranzo21, Kejal Kantarci, Daniel I. Kaufer11, Walter Kukull22, Virginia M.Y. Lee23, James B. Leverenz18, James B. Leverenz17, Simon J.G. Lewis2, Carol F. Lippa18, Carol F. Lippa17, Angela Lunde3, M Masellis21, M Masellis20, M Masellis19, Eliezer Masliah, Pamela J. McLean, Brit Mollenhauer24, Brit Mollenhauer4, Thomas J. Montine25, Thomas J. Montine26, Emilio Moreno27, Emilio Moreno28, Emilio Moreno2, Etsuro Mori27, Etsuro Mori28, Etsuro Mori2, Melissa E. Murray, John T. O'Brien28, John T. O'Brien27, Sotoshi Orimo27, Sotoshi Orimo28, Ronald B. Postuma27, Ronald B. Postuma28, Shankar Ramaswamy28, Shankar Ramaswamy27, Owen A. Ross, David P. Salmon25, David P. Salmon26, Andrew B. Singleton25, Andrew B. Singleton26, Angela Taylor24, Angela Taylor4, Alan Thomas16, Pietro Tiraboschi, Jon B. Toledo, John Q. Trojanowski, Debby W. Tsuang9, Zuzana Walker26, Zuzana Walker8, Masahito Yamada10, Masahito Yamada25, Kenji Kosaka 
TL;DR: The Dementia with Lewy Bodies (DLB) Consortium has refined its recommendations about the clinical and pathologic diagnosis of DLB, updating the previous report, which has been in widespread use for the last decade.
Abstract: The Dementia with Lewy Bodies (DLB) Consortium has refined its recommendations about the clinical and pathologic diagnosis of DLB, updating the previous report, which has been in widespread use for the last decade. The revised DLB consensus criteria now distinguish clearly between clinical features and diagnostic biomarkers, and give guidance about optimal methods to establish and interpret these. Substantial new information has been incorporated about previously reported aspects of DLB, with increased diagnostic weighting given to REM sleep behavior disorder and 123iodine-metaiodobenzylguanidine (MIBG) myocardial scintigraphy. The diagnostic role of other neuroimaging, electrophysiologic, and laboratory investigations is also described. Minor modifications to pathologic methods and criteria are recommended to take account of Alzheimer disease neuropathologic change, to add previously omitted Lewy-related pathology categories, and to include assessments for substantia nigra neuronal loss. Recommendations about clinical management are largely based upon expert opinion since randomized controlled trials in DLB are few. Substantial progress has been made since the previous report in the detection and recognition of DLB as a common and important clinical disorder. During that period it has been incorporated into DSM-5, as major neurocognitive disorder with Lewy bodies. There remains a pressing need to understand the underlying neurobiology and pathophysiology of DLB, to develop and deliver clinical trials with both symptomatic and disease-modifying agents, and to help patients and carers worldwide to inform themselves about the disease, its prognosis, best available treatments, ongoing research, and how to get adequate support.

2,558 citations


Journal ArticleDOI
TL;DR: The GBD (Global Burden of Disease) 2015 study integrated data on disease incidence, prevalence, and mortality to produce consistent, up-to-date estimates for cardiovascular burden, finding that CVDs remain a major cause of health loss for all regions of the world.

2,525 citations


Journal ArticleDOI
01 Mar 2017-Surgery
TL;DR: This new definition and grading system of postoperative pancreatic Fistula should lead to a more universally consistent evaluation of operative outcomes after pancreatic operation and will allow for a better comparison of techniques used to mitigate the rate and clinical impact of a pancreatic fistula.

2,313 citations


Journal ArticleDOI
TL;DR: TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events associated with each procedure.
Abstract: BackgroundAlthough transcatheter aortic-valve replacement (TAVR) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk, less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk. MethodsWe evaluated the clinical outcomes in intermediate-risk patients with severe, symptomatic aortic stenosis in a randomized trial comparing TAVR (performed with the use of a self-expanding prosthesis) with surgical aortic-valve replacement. The primary end point was a composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic-valve replacement. We used Bayesian analytical methods (with a margin of 0.07) to evaluate the noninferiority of TAVR as compared with surgical valve replacement. ResultsA total of 1746 patients underwent randomization at 87 centers. Of these patients, 1660 underwent an attempted TAVR or surgical procedure. The mean (±SD) age of the patients was 7...

2,095 citations


Journal ArticleDOI
TL;DR: William A. Zoghbi, MD, FASE (Chair), David Adams, RCS, RDCS, Fase, Robert O. Bonow,MD, Maurice Enriquez-Sarano, MDs, Elyse Foster, Md, Fases, Paul A. Grayburn, MD-FASE, Rebecca T. Hahn,MD-MMSc, Yuchi Han, PhD, MMSc,* Judy Hung, MD.
Abstract: William A. Zoghbi, MD, FASE (Chair), David Adams, RCS, RDCS, FASE, Robert O. Bonow, MD, Maurice Enriquez-Sarano, MD, Elyse Foster, MD, FASE, Paul A. Grayburn, MD, FASE, Rebecca T. Hahn, MD, FASE, Yuchi Han, MD, MMSc,* Judy Hung, MD, FASE, Roberto M. Lang, MD, FASE, Stephen H. Little, MD, FASE, Dipan J. Shah, MD, MMSc,* Stanton Shernan, MD, FASE, Paaladinesh Thavendiranathan, MD, MSc, FASE,* James D. Thomas, MD, FASE, and Neil J. Weissman, MD, FASE, Houston and Dallas, Texas; Durham, North Carolina; Chicago, Illinois; Rochester, Minnesota; San Francisco, California; New York, New York; Philadelphia, Pennsylvania; Boston, Massachusetts; Toronto, Ontario, Canada; and Washington, DC

2,030 citations


Journal ArticleDOI
TL;DR: Treatment with lutetium‐177 (177Lu)–Dotatate resulted in markedly longer progression‐free survival and a significantly higher response rate than high‐dose octreotide LAR among patients with advanced midgut neuroendocrine tumors.
Abstract: BackgroundPatients with advanced midgut neuroendocrine tumors who have had disease progression during first-line somatostatin analogue therapy have limited therapeutic options. This randomized, controlled trial evaluated the efficacy and safety of lutetium-177 (177Lu)–Dotatate in patients with advanced, progressive, somatostatin-receptor–positive midgut neuroendocrine tumors. MethodsWe randomly assigned 229 patients who had well-differentiated, metastatic midgut neuroendocrine tumors to receive either 177Lu-Dotatate (116 patients) at a dose of 7.4 GBq every 8 weeks (four intravenous infusions, plus best supportive care including octreotide long-acting repeatable [LAR] administered intramuscularly at a dose of 30 mg) (177Lu-Dotatate group) or octreotide LAR alone (113 patients) administered intramuscularly at a dose of 60 mg every 4 weeks (control group). The primary end point was progression-free survival. Secondary end points included the objective response rate, overall survival, safety, and the side-ef...

1,975 citations


Journal ArticleDOI
Seth Flaxman1, Rupert R A Bourne2, Serge Resnikoff3, Serge Resnikoff4, Peter Ackland5, Tasanee Braithwaite6, Maria V Cicinelli, Aditi Das7, Jost B. Jonas8, Jill E Keeffe9, John H. Kempen10, Janet L Leasher11, Hans Limburg, Kovin Naidoo12, Kovin Naidoo4, Konrad Pesudovs13, Alexander J Silvester, Gretchen A Stevens14, Nina Tahhan4, Nina Tahhan3, Tien Yin Wong15, Hugh R. Taylor16, Rupert R A Bourne2, Aries Arditi, Yaniv Barkana, Banu Bozkurt17, Alain M. Bron, Donald L. Budenz18, Feng Cai, Robert J Casson19, Usha Chakravarthy20, Jaewan Choi, Maria Vittoria Cicinelli, Nathan Congdon20, Reza Dana21, Rakhi Dandona22, Lalit Dandona23, Iva Dekaris, Monte A. Del Monte24, Jenny deva25, Laura E. Dreer26, Leon B. Ellwein27, Marcela Frazier26, Kevin D. Frick28, David S. Friedman28, João M. Furtado29, H. Gao30, Gus Gazzard31, Ronnie George32, Stephen Gichuhi33, Victor H. Gonzalez, Billy R. Hammond34, Mary Elizabeth Hartnett35, Minguang He16, James F. Hejtmancik, Flavio E. Hirai36, John J Huang37, April D. Ingram38, Jonathan C. Javitt28, Jost B. Jonas8, Charlotte E. Joslin39, John H Kempen10, Moncef Khairallah, Rohit C Khanna9, Judy E. Kim40, George N. Lambrou41, Van C. Lansingh, Paolo Lanzetta42, Jennifer I. Lim43, Kaweh Mansouri, Anu A. Mathew44, Alan R. Morse, Beatriz Munoz, David C. Musch24, Vinay Nangia, Maria Palaiou10, Maurizio Battaglia Parodi, Fernando Yaacov Pena, Tunde Peto20, Harry A. Quigley, Murugesan Raju45, Pradeep Y. Ramulu46, Zane Rankin15, Dana Reza21, Alan L. Robin23, Luca Rossetti47, Jinan B. Saaddine46, Mya Sandar15, Janet B. Serle48, Tueng T. Shen23, Rajesh K. Shetty49, Pamela C. Sieving27, Juan Carlos Silva50, Rita S. Sitorus51, Dwight Stambolian52, Gretchen Stevens14, Hugh Taylor16, Jaime Tejedor, James M. Tielsch28, Miltiadis K. Tsilimbaris53, Jan C. van Meurs, Rohit Varma54, Gianni Virgili55, Ya Xing Wang56, Ningli Wang56, Sheila K. West, Peter Wiedemann57, Tien Wong15, Richard Wormald6, Yingfeng Zheng15 
Imperial College London1, Anglia Ruskin University2, University of New South Wales3, Brien Holden Vision Institute4, International Agency for the Prevention of Blindness5, Moorfields Eye Hospital6, York Hospital7, Heidelberg University8, L V Prasad Eye Institute9, Massachusetts Eye and Ear Infirmary10, Nova Southeastern University11, University of KwaZulu-Natal12, National Health and Medical Research Council13, World Health Organization14, National University of Singapore15, University of Melbourne16, Selçuk University17, University of Miami18, University of Adelaide19, Queen's University Belfast20, Harvard University21, The George Institute for Global Health22, University of Washington23, University of Michigan24, Universiti Tunku Abdul Rahman25, University of Alabama at Birmingham26, National Institutes of Health27, Johns Hopkins University28, University of São Paulo29, Henry Ford Health System30, University College London31, Sankara Nethralaya32, University of Nairobi33, University of Georgia34, University of Utah35, Federal University of São Paulo36, Yale University37, Alberta Children's Hospital38, University of Illinois at Chicago39, Medical College of Wisconsin40, Novartis41, University of Udine42, University of Illinois at Urbana–Champaign43, Royal Children's Hospital44, University of Missouri45, Centers for Disease Control and Prevention46, University of Milan47, Icahn School of Medicine at Mount Sinai48, Mayo Clinic49, Pan American Health Organization50, University of Indonesia51, University of Pennsylvania52, University of Crete53, University of Southern California54, University of Florence55, Capital Medical University56, Leipzig University57
TL;DR: A series of regression models were fitted to estimate the proportion of moderate or severe vision impairment and blindness by cause, age, region, and year, and found that world regions varied markedly in the causes of blindness and vision impairment in this age group.

Journal ArticleDOI
TL;DR: This guideline is intended to provide new and updated evidence-based recommendations for the prevention of SSI and should be incorporated into comprehensive surgical quality improvement programs to improve patient safety.
Abstract: Importance The human and financial costs of treating surgical site infections (SSIs) are increasing. The number of surgical procedures performed in the United States continues to rise, and surgical patients are initially seen with increasingly complex comorbidities. It is estimated that approximately half of SSIs are deemed preventable using evidence-based strategies. Objective To provide new and updated evidence-based recommendations for the prevention of SSI. Evidence Review A targeted systematic review of the literature was conducted in MEDLINE, EMBASE, CINAHL, and the Cochrane Library from 1998 through April 2014. A modified Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach was used to assess the quality of evidence and the strength of the resulting recommendation and to provide explicit links between them. Of 5759 titles and abstracts screened, 896 underwent full-text review by 2 independent reviewers. After exclusions, 170 studies were extracted into evidence tables, appraised, and synthesized. Findings Before surgery, patients should shower or bathe (full body) with soap (antimicrobial or nonantimicrobial) or an antiseptic agent on at least the night before the operative day. Antimicrobial prophylaxis should be administered only when indicated based on published clinical practice guidelines and timed such that a bactericidal concentration of the agents is established in the serum and tissues when the incision is made. In cesarean section procedures, antimicrobial prophylaxis should be administered before skin incision. Skin preparation in the operating room should be performed using an alcohol-based agent unless contraindicated. For clean and clean-contaminated procedures, additional prophylactic antimicrobial agent doses should not be administered after the surgical incision is closed in the operating room, even in the presence of a drain. Topical antimicrobial agents should not be applied to the surgical incision. During surgery, glycemic control should be implemented using blood glucose target levels less than 200 mg/dL, and normothermia should be maintained in all patients. Increased fraction of inspired oxygen should be administered during surgery and after extubation in the immediate postoperative period for patients with normal pulmonary function undergoing general anesthesia with endotracheal intubation. Transfusion of blood products should not be withheld from surgical patients as a means to prevent SSI. Conclusions and Relevance This guideline is intended to provide new and updated evidence-based recommendations for the prevention of SSI and should be incorporated into comprehensive surgical quality improvement programs to improve patient safety.

Journal ArticleDOI
TL;DR: This 2017 Consensus Statement is to provide a state-of-the-art review of the field of catheter and surgical ablation of AF and to report the findings of a writing group, convened by these five international societies.

Journal ArticleDOI
TL;DR: Atezolizumab showed encouraging durable response rates, survival, and tolerability, supporting its therapeutic use in untreated metastatic urothelial cancer.

Journal ArticleDOI
TL;DR: This guideline establishes clinical practice recommendations for the diagnosis of obstructive sleep apnea (OSA) in adults and is intended for use in conjunction with other American Academy of Sleep Medicine guidelines on the evaluation and treatment of sleep-disordered breathing in adults.
Abstract: Introduction:This guideline establishes clinical practice recommendations for the diagnosis of obstructive sleep apnea (OSA) in adults and is intended for use in conjunction with other American Aca...

Journal ArticleDOI
TL;DR: The presence of CHIP in peripheral‐blood cells was associated with nearly a doubling in the risk of coronary heart disease in humans and with accelerated atherosclerosis in mice.
Abstract: BackgroundClonal hematopoiesis of indeterminate potential (CHIP), which is defined as the presence of an expanded somatic blood-cell clone in persons without other hematologic abnormalities, is common among older persons and is associated with an increased risk of hematologic cancer. We previously found preliminary evidence for an association between CHIP and atherosclerotic cardiovascular disease, but the nature of this association was unclear. MethodsWe used whole-exome sequencing to detect the presence of CHIP in peripheral-blood cells and associated such presence with coronary heart disease using samples from four case–control studies that together enrolled 4726 participants with coronary heart disease and 3529 controls. To assess causality, we perturbed the function of Tet2, the second most commonly mutated gene linked to clonal hematopoiesis, in the hematopoietic cells of atherosclerosis-prone mice. ResultsIn nested case–control analyses from two prospective cohorts, carriers of CHIP had a risk of c...

Journal ArticleDOI
TL;DR: The addition of the multitargeted kinase inhibitor midostaurin to standard chemotherapy significantly prolonged overall and event‐free survival among patients with AML and a FLT3 mutation.
Abstract: BackgroundPatients with acute myeloid leukemia (AML) and a FLT3 mutation have poor outcomes. We conducted a phase 3 trial to determine whether the addition of midostaurin — an oral multitargeted kinase inhibitor that is active in patients with a FLT3 mutation — to standard chemotherapy would prolong overall survival in this population. MethodsWe screened 3277 patients, 18 to 59 years of age, who had newly diagnosed AML for FLT3 mutations. Patients were randomly assigned to receive standard chemotherapy (induction therapy with daunorubicin and cytarabine and consolidation therapy with high-dose cytarabine) plus either midostaurin or placebo; those who were in remission after consolidation therapy entered a maintenance phase in which they received either midostaurin or placebo. Randomization was stratified according to subtype of FLT3 mutation: point mutation in the tyrosine kinase domain (TKD) or internal tandem duplication (ITD) mutation with either a high ratio (>0.7) or a low ratio (0.05 to 0.7) of muta...

Journal ArticleDOI
Rupert R A Bourne1, Seth Flaxman2, Tasanee Braithwaite1, Maria V Cicinelli, Aditi Das, Jost B. Jonas3, Jill E Keeffe4, John H Kempen5, Janet L Leasher6, Hans Limburg, Kovin Naidoo7, Kovin Naidoo8, Konrad Pesudovs9, Serge Resnikoff7, Serge Resnikoff10, Alexander J Silvester11, Gretchen A Stevens12, Nina Tahhan10, Nina Tahhan7, Tien Yin Wong13, Hugh R. Taylor14, Rupert R A Bourne1, Peter Ackland, Aries Arditi, Yaniv Barkana, Banu Bozkurt15, Alain M. Bron16, Donald L. Budenz17, Feng Cai, Robert J Casson18, Usha Chakravarthy19, Jaewan Choi, Maria Vittoria Cicinelli, Nathan Congdon19, Reza Dana20, Rakhi Dandona21, Lalit Dandona22, Iva Dekaris, Monte A. Del Monte23, Jenny deva24, Laura Dreer25, Leon B. Ellwein26, Marcela Frazier25, Kevin D. Frick27, David S. Friedman27, João M. Furtado28, H. Gao29, Gus Gazzard30, Ronnie George, Stephen Gichuhi31, Victor H. Gonzalez, Billy R. Hammond32, Mary Elizabeth Hartnett33, Minguang He14, James F. Hejtmancik26, Flavio E. Hirai34, John J Huang35, April D. Ingram36, Jonathan C. Javitt27, Jost B. Jonas3, Charlotte E. Joslin, John H. Kempen20, John H. Kempen37, Moncef Khairallah, Rohit C Khanna4, Judy E. Kim38, George N. Lambrou39, Van C. Lansingh, Paolo Lanzetta40, Jennifer I. Lim41, Kaweh Mansouri, Anu A. Mathew42, Alan R. Morse, Beatriz Munoz27, David C. Musch23, Vinay Nangia, Maria Palaiou20, Maurizio Battaglia Parodi, Fernando Yaacov Pena42, Tunde Peto19, Harry A. Quigley27, Murugesan Raju43, Pradeep Y. Ramulu27, Alan L. Robin27, Luca Rossetti44, Jinan B. Saaddine45, Mya Sandar46, Janet B. Serle47, Tueng T. Shen22, Rajesh K. Shetty48, Pamela C. Sieving26, Juan Carlos Silva49, Rita S. Sitorus50, Dwight Stambolian37, Gretchen Stevens12, Hugh Taylor14, Jaime Tejedor, James M. Tielsch27, Miltiadis K. Tsilimbaris51, Jan C. van Meurs52, Rohit Varma53, Gianni Virgili54, Jimmy Volmink55, Ya Xing Wang, Ningli Wang56, Sheila K. West27, Peter Wiedemann57, Tien Wong13, Richard Wormald58, Yingfeng Zheng46 
Anglia Ruskin University1, University of Oxford2, Heidelberg University3, L V Prasad Eye Institute4, Massachusetts Eye and Ear Infirmary5, Nova Southeastern University6, Brien Holden Vision Institute7, University of KwaZulu-Natal8, Flinders University9, University of New South Wales10, Royal Liverpool University Hospital11, World Health Organization12, National University of Singapore13, University of Melbourne14, Selçuk University15, University of Burgundy16, University of Miami17, University of Adelaide18, Queen's University Belfast19, Harvard University20, The George Institute for Global Health21, University of Washington22, University of Michigan23, Universiti Tunku Abdul Rahman24, University of Alabama25, National Institutes of Health26, Johns Hopkins University27, University of São Paulo28, Henry Ford Health System29, University College London30, University of Nairobi31, University of Georgia32, University of Utah33, Federal University of São Paulo34, Yale University35, Alberta Children's Hospital36, University of Pennsylvania37, Medical College of Wisconsin38, Novartis39, University of Udine40, University of Illinois at Urbana–Champaign41, Royal Children's Hospital42, University of Missouri43, University of Milan44, Centers for Disease Control and Prevention45, Singapore National Eye Center46, Icahn School of Medicine at Mount Sinai47, Mayo Clinic48, Pan American Health Organization49, University of Indonesia50, University of Crete51, Erasmus University Rotterdam52, University of Southern California53, University of Florence54, Stellenbosch University55, Capital Medical University56, Leipzig University57, Moorfields Eye Hospital58
TL;DR: There is an ongoing reduction in the age-standardised prevalence of blindness and visual impairment, yet the growth and ageing of the world's population is causing a substantial increase in number of people affected, highlighting the need to scale up vision impairment alleviation efforts at all levels.

Journal ArticleDOI
TL;DR: This guideline describes a standard approach to solid tumour measurements and definitions for objective change in tumour size for use in trials in which an immunotherapy is used and defines the minimum datapoints required from future trials to facilitate the compilation of a data warehouse to later validate iRECIST.
Abstract: Tumours respond differently to immunotherapies compared with chemotherapeutic drugs, raising questions about the assessment of changes in tumour burden-a mainstay of evaluation of cancer therapeutics that provides key information about objective response and disease progression. A consensus guideline-iRECIST-was developed by the RECIST working group for the use of modified Response Evaluation Criteria in Solid Tumours (RECIST version 1.1) in cancer immunotherapy trials, to ensure consistent design and data collection, facilitate the ongoing collection of trial data, and ultimate validation of the guideline. This guideline describes a standard approach to solid tumour measurements and definitions for objective change in tumour size for use in trials in which an immunotherapy is used. Additionally, it defines the minimum datapoints required from future trials and those currently in development to facilitate the compilation of a data warehouse to use to later validate iRECIST. An unprecedented number of trials have been done, initiated, or are planned to test new immune modulators for cancer therapy using a variety of modified response criteria. This guideline will allow consistent conduct, interpretation, and analysis of trials of immunotherapies.

Journal ArticleDOI
11 Jul 2017-JAMA
TL;DR: This study assesses overall survival associated with electronic patient-reported symptom monitoring vs usual care during routine cancer treatment.
Abstract: This study assesses overall survival associated with electronic patient-reported symptom monitoring vs usual care during routine cancer treatment

Journal ArticleDOI
TL;DR: The authors present the ACR TI-RADS Committee's recommendations, which provide guidance regarding management of thyroid nodules on the basis of their ultrasound appearance, and describe the committee's future directions.
Abstract: Thyroid nodules are a frequent finding on neck sonography. Most nodules are benign; therefore, many nodules are biopsied to identify the small number that are malignant or require surgery for a definitive diagnosis. Since 2009, many professional societies and investigators have proposed ultrasound-based risk stratification systems to identify nodules that warrant biopsy or sonographic follow-up. Because some of these systems were founded on the BI-RADS® classification that is widely used in breast imaging, their authors chose to apply the acronym TI-RADS, for Thyroid Imaging, Reporting and Data System. In 2012, the ACR convened committees to (1) provide recommendations for reporting incidental thyroid nodules, (2) develop a set of standard terms (lexicon) for ultrasound reporting, and (3) propose a TI-RADS on the basis of the lexicon. The committees published the results of the first two efforts in 2015. In this article, the authors present the ACR TI-RADS Committee's recommendations, which provide guidance regarding management of thyroid nodules on the basis of their ultrasound appearance. The authors also describe the committee's future directions.

Journal ArticleDOI
TL;DR: Clinical diagnostic criteria, published in 1996 by the National Institute of Neurological Disorders and Stroke/Society for PSP have excellent specificity, but their sensitivity is limited for variant PSP syndromes with presentations other than Richardson's syndrome.
Abstract: Background: PSP is a neuropathologically defined disease entity. Clinical diagnostic criteria, published in 1996 by the National Institute of Neurological Disorders and Stroke/Society for PSP, have excellent specificity, but their sensitivity is limited for variant PSP syndromes with presentations other than Richardson's syndrome. Objective: We aimed to provide an evidence- and consensus-based revision of the clinical diagnostic criteria for PSP. Methods: We searched the PubMed, Cochrane, Medline, and PSYCInfo databases for articles published in English since 1996, using postmortem diagnosis or highly specific clinical criteria as the diagnostic standard. Second, we generated retrospective standardized clinical data from patients with autopsy-confirmed PSP and control diseases. On this basis, diagnostic criteria were drafted, optimized in two modified Delphi evaluations, submitted to structured discussions with consensus procedures during a 2-day meeting, and refined in three further Delphi rounds. Results: Defined clinical, imaging, laboratory, and genetic findings serve as mandatory basic features, mandatory exclusion criteria, or context-dependent exclusion criteria. We identified four functional domains (ocular motor dysfunction, postural instability, akinesia, and cognitive dysfunction) as clinical predictors of PSP. Within each of these domains, we propose three clinical features that contribute different levels of diagnostic certainty. Specific combinations of these features define the diagnostic criteria, stratified by three degrees of diagnostic certainty (probable PSP, possible PSP, and suggestive of PSP). Clinical clues and imaging findings represent supportive features. Conclusions: Here, we present new criteria aimed to optimize early, sensitive, and specific clinical diagnosis of PSP on the basis of currently available evidence.

Journal ArticleDOI
TL;DR: The risk of liver‐related mortality increases exponentially with increase in fibrosis stage; these data have important implications in assessing the utility of each stage and benefits of regression of fibrosis from one stage to another.

Journal ArticleDOI
TL;DR: This evidence‐based guideline recommends treating gender‐dysphoric/gender‐incongruent adolescents who have entered puberty at Tanner Stage G2/B2 by suppression with gonadotropin‐releasing hormone agonists and recommends adding gender‐affirming hormones after a multidisciplinary team has confirmed the persistence of gender dysphoria/gender incongruence.
Abstract: Objective To update the "Endocrine Treatment of Transsexual Persons: An Endocrine Society Clinical Practice Guideline," published by the Endocrine Society in 2009. Participants The participants include an Endocrine Society-appointed task force of nine experts, a methodologist, and a medical writer. Evidence This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation approach to describe the strength of recommendations and the quality of evidence. The task force commissioned two systematic reviews and used the best available evidence from other published systematic reviews and individual studies. Consensus process Group meetings, conference calls, and e-mail communications enabled consensus. Endocrine Society committees, members and cosponsoring organizations reviewed and commented on preliminary drafts of the guidelines. Conclusion Gender affirmation is multidisciplinary treatment in which endocrinologists play an important role. Gender-dysphoric/gender-incongruent persons seek and/or are referred to endocrinologists to develop the physical characteristics of the affirmed gender. They require a safe and effective hormone regimen that will (1) suppress endogenous sex hormone secretion determined by the person's genetic/gonadal sex and (2) maintain sex hormone levels within the normal range for the person's affirmed gender. Hormone treatment is not recommended for prepubertal gender-dysphoric/gender-incongruent persons. Those clinicians who recommend gender-affirming endocrine treatments-appropriately trained diagnosing clinicians (required), a mental health provider for adolescents (required) and mental health professional for adults (recommended)-should be knowledgeable about the diagnostic criteria and criteria for gender-affirming treatment, have sufficient training and experience in assessing psychopathology, and be willing to participate in the ongoing care throughout the endocrine transition. We recommend treating gender-dysphoric/gender-incongruent adolescents who have entered puberty at Tanner Stage G2/B2 by suppression with gonadotropin-releasing hormone agonists. Clinicians may add gender-affirming hormones after a multidisciplinary team has confirmed the persistence of gender dysphoria/gender incongruence and sufficient mental capacity to give informed consent to this partially irreversible treatment. Most adolescents have this capacity by age 16 years old. We recognize that there may be compelling reasons to initiate sex hormone treatment prior to age 16 years, although there is minimal published experience treating prior to 13.5 to 14 years of age. For the care of peripubertal youths and older adolescents, we recommend that an expert multidisciplinary team comprised of medical professionals and mental health professionals manage this treatment. The treating physician must confirm the criteria for treatment used by the referring mental health practitioner and collaborate with them in decisions about gender-affirming surgery in older adolescents. For adult gender-dysphoric/gender-incongruent persons, the treating clinicians (collectively) should have expertise in transgender-specific diagnostic criteria, mental health, primary care, hormone treatment, and surgery, as needed by the patient. We suggest maintaining physiologic levels of gender-appropriate hormones and monitoring for known risks and complications. When high doses of sex steroids are required to suppress endogenous sex steroids and/or in advanced age, clinicians may consider surgically removing natal gonads along with reducing sex steroid treatment. Clinicians should monitor both transgender males (female to male) and transgender females (male to female) for reproductive organ cancer risk when surgical removal is incomplete. Additionally, clinicians should persistently monitor adverse effects of sex steroids. For gender-affirming surgeries in adults, the treating physician must collaborate with and confirm the criteria for treatment used by the referring physician. Clinicians should avoid harming individuals (via hormone treatment) who have conditions other than gender dysphoria/gender incongruence and who may not benefit from the physical changes associated with this treatment.

Journal ArticleDOI
01 Jan 2017
TL;DR: 9 organizational strategies to promote physician engagement are summarized and how Mayo Clinic has operationalized some of these approaches is described, demonstrating that deliberate, sustained, and comprehensive efforts by the organization to reduce burnout and promote engagement can make a difference.
Abstract: These are challenging times for health care executives. The health care field is experiencing unprecedented changes that threaten the survival of many health care organizations. To successfully navigate these challenges, health care executives need committed and productive physicians working in collaboration with organization leaders. Unfortunately, national studies suggest that at least 50% of US physicians are experiencing professional burnout, indicating that most executives face this challenge with a disillusioned physician workforce. Burnout is a syndrome characterized by exhaustion, cynicism, and reduced effectiveness. Physician burnout has been shown to influence quality of care, patient safety, physician turnover, and patient satisfaction. Although burnout is a system issue, most institutions operate under the erroneous framework that burnout and professional satisfaction are solely the responsibility of the individual physician. Engagement is the positive antithesis of burnout and is characterized by vigor, dedication, and absorption in work. There is a strong business case for organizations to invest in efforts to reduce physician burnout and promote engagement. Herein, we summarize 9 organizational strategies to promote physician engagement and describe how we have operationalized some of these approaches at Mayo Clinic. Our experience demonstrates that deliberate, sustained, and comprehensive efforts by the organization to reduce burnout and promote engagement can make a difference. Many effective interventions are relatively inexpensive, and small investments can have a large impact. Leadership and sustained attention from the highest level of the organization are the keys to making progress.

Journal ArticleDOI
02 Nov 2017-Nature
TL;DR: A genome-wide association study of breast cancer in 122,977 cases and 105,974 controls of European ancestry and 14,068 cases and 13,104 controls of East Asian ancestry finds that heritability of Breast cancer due to all single-nucleotide polymorphisms in regulatory features was 2–5-fold enriched relative to the genome- wide average.
Abstract: Breast cancer risk is influenced by rare coding variants in susceptibility genes, such as BRCA1, and many common, mostly non-coding variants. However, much of the genetic contribution to breast cancer risk remains unknown. Here we report the results of a genome-wide association study of breast cancer in 122,977 cases and 105,974 controls of European ancestry and 14,068 cases and 13,104 controls of East Asian ancestry. We identified 65 new loci that are associated with overall breast cancer risk at P < 5 × 10-8. The majority of credible risk single-nucleotide polymorphisms in these loci fall in distal regulatory elements, and by integrating in silico data to predict target genes in breast cells at each locus, we demonstrate a strong overlap between candidate target genes and somatic driver genes in breast tumours. We also find that heritability of breast cancer due to all single-nucleotide polymorphisms in regulatory features was 2-5-fold enriched relative to the genome-wide average, with strong enrichment for particular transcription factor binding sites. These results provide further insight into genetic susceptibility to breast cancer and will improve the use of genetic risk scores for individualized screening and prevention.

Journal ArticleDOI
TL;DR: This selection from the NCCN Guidelines for Non-Small Cell Lung Cancer (NSCLC) focuses on targeted therapies and immunotherapies for metastatic NSCLC, because therapeutic recommendations are rapidly changing for metastasis disease.
Abstract: This selection from the NCCN Guidelines for Non-Small Cell Lung Cancer (NSCLC) focuses on targeted therapies and immunotherapies for metastatic NSCLC, because therapeutic recommendations are rapidly changing for metastatic disease. For example, new recommendations were added for atezolizumab, ceritinib, osimertinib, and pembrolizumab for the 2017 updates.

Journal ArticleDOI
TL;DR: In the setting of established acute kidney injury, fluid management can be challenging, and impaired capacity of urine output and urine concentration and dilution should be taken into consideration when designing fluid therapy.
Abstract: Over 50% of the human body is comprised of fluids that are distributed in defined compartments. Although compartmentalized, these fluids are dynamically connected. Fluids, electrolytes, and acid-base

Journal ArticleDOI
19 Oct 2017-Blood
TL;DR: SCHOLAR-1, an international, multicohort retrospective non-Hodgkin lymphoma research study, retrospectively evaluated outcomes in patients with refractory DLBCL, the largest patient-level pooled retrospective analysis to characterize response rates and survival for a population of patients withRefractoryDLBCL.

Journal ArticleDOI
TL;DR: Abemaciclib plus a nonsteroidal aromatase inhibitor was effective as initial therapy, significantly improving progression-free survival and objective response rate and demonstrating a tolerable safety profile in women with HR-positive, HER2-negative advanced breast cancer.
Abstract: PurposeAbemaciclib, a cyclin-dependent kinase 4 and 6 inhibitor, demonstrated efficacy as monotherapy and in combination with fulvestrant in women with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer previously treated with endocrine therapy.MethodsMONARCH 3 is a double-blind, randomized phase III study of abemaciclib or placebo plus a nonsteroidal aromatase inhibitor in 493 postmenopausal women with HR-positive, HER2-negative advanced breast cancer who had no prior systemic therapy in the advanced setting. Patients received abemaciclib or placebo (150 mg twice daily continuous schedule) plus either 1 mg anastrozole or 2.5 mg letrozole, daily. The primary objective was investigator-assessed progression-free survival. Secondary objectives included response evaluation and safety. A planned interim analysis occurred after 189 events.ResultsMedian progression-free survival was significantly prolonged in the abemaciclib arm (hazard ratio, 0.54; 95...