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Sample records for heberden society clinical

  1. From the Library of the William Heberdens

    PubMed Central

    Talbott, John H.

    1965-01-01

    Several books and documents from the personal library of William Heberden, Sr., and his son, William Heberden, Jr., have been given to the Countway Library through a direct descendant. One of the most interesting items is the senior Heberden's desk copy of his own Commentaries on the History and Cure of Disease, prepared in Latin and assembled by the printer with interleaves for revision. In addition, and English translation of his masterpiece, medical books from his private library, personal documents, and a number of letters are included. The decision for disposition, based upon several factors, was difficult to reach, since at least four libraries in the United States have a substantial collection of Heberden's works and the items could have been properly placed in any one. PMID:14306032

  2. American Society for Clinical Pathology

    MedlinePlus

    ... ASCP Selects ArborMetrix to Drive Patient-Centric National Pathology Quality Registry ePolicy News August 2017 July 2017 ... Measure Copyright © 2017 by American Society for Clinical Pathology. All Rights Reserved. Terms of Use About ASCP ...

  3. American Society of Clinical Oncology

    MedlinePlus

    ... The 10th Joint MSKCC/HSS/IOR Course in Musculoskeletal Tumor Pathology and Clinical Oncology New York, New York, United ... The 10th Joint MSKCC/HSS/IOR Course in Musculoskeletal Tumor Pathology and Clinical Oncology Memorial Sloan Kettering Cancer Center ...

  4. European Society for Clinical Virology - winter meeting.

    PubMed

    Westh, Henrik

    2004-02-01

    The European Society for Clinical Virology annual winter meeting mainly appeals to clinical virologists interested in human disease. Basic and clinical data were presented, highlighting a number of interesting findings. This report briefly describes options in HIV antiviral treatment, and focuses on fusion inhibitors, a new anti-HIV class of drugs. Recent improvements in experimental DNA vaccines are also presented.

  5. Postmastectomy Radiotherapy: An American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Focused Guideline Update.

    PubMed

    Recht, Abram; Comen, Elizabeth A; Fine, Richard E; Fleming, Gini F; Hardenbergh, Patricia H; Ho, Alice Y; Hudis, Clifford A; Hwang, E Shelley; Kirshner, Jeffrey J; Morrow, Monica; Salerno, Kilian E; Sledge, George W; Solin, Lawrence J; Spears, Patricia A; Whelan, Timothy J; Somerfield, Mark R; Edge, Stephen B

    A joint American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology panel convened to develop a focused update of the American Society of Clinical Oncology guideline concerning use of postmastectomy radiotherapy (PMRT).

  6. A history of the American Society for Clinical Investigation

    PubMed Central

    Howell, Joel D.

    2009-01-01

    One hundred years ago, in 1909, the American Society for Clinical Investigation (ASCI) held its first annual meeting. The founding members based this new society on a revolutionary approach to research that emphasized newer physiological methods. In 1924 the ASCI started a new journal, the Journal of Clinical Investigation. The ASCI has also held an annual meeting almost every year. The society has long debated who could be a member, with discussions about whether members must be physicians, what sorts of research they could do, and the role of women within the society. The ASCI has also grappled with what else the society should do, especially whether it ought to take a stand on policy issues. ASCI history has reflected changing social, political, and economic contexts, including several wars, concerns about the ethics of biomedical research, massive increases in federal research funding, and an increasingly large and specialized medical environment. PMID:19348041

  7. Antiemetics: American Society of Clinical Oncology clinical practice guideline update.

    PubMed

    Basch, Ethan; Prestrud, Ann Alexis; Hesketh, Paul J; Kris, Mark G; Feyer, Petra C; Somerfield, Mark R; Chesney, Maurice; Clark-Snow, Rebecca Anne; Flaherty, Anne Marie; Freundlich, Barbara; Morrow, Gary; Rao, Kamakshi V; Schwartz, Rowena N; Lyman, Gary H

    2011-11-01

    To update the American Society of Clinical Oncology (ASCO) guideline for antiemetics in oncology. A systematic review of the medical literature was completed to inform this update. MEDLINE, the Cochrane Collaboration Library, and meeting materials from ASCO and the Multinational Association for Supportive Care in Cancer were all searched. Primary outcomes of interest were complete response and rates of any vomiting or nausea. Thirty-seven trials met prespecified inclusion and exclusion criteria for this systematic review. Two systematic reviews from the Cochrane Collaboration were identified; one surveyed the pediatric literature. The other compared the relative efficacy of the 5-hydroxytryptamine-3 (5-HT(3)) receptor antagonists. Combined anthracycline and cyclophosphamide regimens were reclassified as highly emetic. Patients who receive this combination or any highly emetic agents should receive a 5-HT(3) receptor antagonist, dexamethasone, and a neurokinin 1 (NK(1)) receptor antagonist. A large trial validated the equivalency of fosaprepitant, a single-day intravenous formulation, with aprepitant; either therapy is appropriate. Preferential use of palonosetron is recommended for moderate emetic risk regimens, combined with dexamethasone. For low-risk agents, patients can be offered dexamethasone before the first dose of chemotherapy. Patients undergoing high emetic risk radiation therapy should receive a 5-HT(3) receptor antagonist before each fraction and for 24 hours after treatment and may receive a 5-day course of dexamethasone during fractions 1 to 5. The Update Committee noted the importance of continued symptom monitoring throughout therapy. Clinicians underestimate the incidence of nausea, which is not as well controlled as emesis.

  8. American Cancer Society/American Society of Clinical Oncology Breast Cancer Survivorship Care Guideline.

    PubMed

    Runowicz, Carolyn D; Leach, Corinne R; Henry, N Lynn; Henry, Karen S; Mackey, Heather T; Cowens-Alvarado, Rebecca L; Cannady, Rachel S; Pratt-Chapman, Mandi L; Edge, Stephen B; Jacobs, Linda A; Hurria, Arti; Marks, Lawrence B; LaMonte, Samuel J; Warner, Ellen; Lyman, Gary H; Ganz, Patricia A

    2016-02-20

    The purpose of the American Cancer Society/American Society of Clinical Oncology Breast Cancer Survivorship Care Guideline is to provide recommendations to assist primary care and other clinicians in the care of female adult survivors of breast cancer. A systematic review of the literature was conducted using PubMed through April 2015. A multidisciplinary expert workgroup with expertise in primary care, gynecology, surgical oncology, medical oncology, radiation oncology, and nursing was formed and tasked with drafting the Breast Cancer Survivorship Care Guideline. A total of 1,073 articles met inclusion criteria; and, after full text review, 237 were included as the evidence base. Patients should undergo regular surveillance for breast cancer recurrence, including evaluation with a cancer-related history and physical examination, and should be screened for new primary breast cancer. Data do not support performing routine laboratory tests or imaging tests in asymptomatic patients to evaluate for breast cancer recurrence. Primary care clinicians should counsel patients about the importance of maintaining a healthy lifestyle, monitor for post-treatment symptoms that can adversely affect quality of life, and monitor for adherence to endocrine therapy. Recommendations provided in this guideline are based on current evidence in the literature and expert consensus opinion. Most of the evidence is not sufficient to warrant a strong evidence-based recommendation. Recommendations on surveillance for breast cancer recurrence, screening for second primary cancers, assessment and management of physical and psychosocial long-term and late effects of breast cancer and its treatment, health promotion, and care coordination/practice implications are made.This guideline was developed through a collaboration between the American Cancer Society and the American Society of Clinical Oncology and has been published jointly by invitation and consent in both CA: A Cancer Journal for

  9. (Short overview of the Mexican Society of Clinical Chemistry meetings)

    SciTech Connect

    Burtis, C.

    1991-01-01

    Organized and chaired session on instrument evaluation at the XIV Congreso Nacional De Quimica Clinica which is the National Meeting of the Mexican Society of Clinical Chemistry. In addition, I presented a paper on calibration at a Congress workshop and spoke on the impact of technology in a symposium on quality control.

  10. Implementation of the American Society of Clinical Oncology and Oncology Nursing Society chemotherapy safety standards.

    PubMed

    Vioral, Anna N; Kennihan, Heather K

    2012-12-01

    Chemotherapy involves an intricate, high-risk, multidisciplinary process of prescribing, dispensing, and administering complex multimedication regimens with narrow therapeutic indices. Chemotherapeutic agents also require safe-handling precautions for patients and healthcare providers. In addition, a number of chemotherapy and targeted therapies have expanded to nononcology populations. This complexity demands standardization of chemotherapy practice for all healthcare providers to ensure safe outcomes. This article describes one organization's multidisciplinary effort to standardize chemotherapy practice according to the American Society of Clinical Oncology and Oncology Nursing Society's 31 safety standards for chemotherapy administration. The article also describes how the organization integrated and developed standards of practice using interdisciplinary approaches. The educational processes used during implementation and the lessons learned are discussed to assist healthcare providers involved in standardizing chemotherapy administration. The article equips healthcare professionals with a multidisciplinary process for high-quality clinical standards of practice that may reduce errors and ensure safety.

  11. Treatment of Cushing's Syndrome: An Endocrine Society Clinical Practice Guideline

    PubMed Central

    Nieman, Lynnette K.; Biller, Beverly M. K.; Findling, James W.; Murad, M. Hassan; Newell-Price, John; Savage, Martin O.; Tabarin, Antoine

    2015-01-01

    Objective: The objective is to formulate clinical practice guidelines for treating Cushing's syndrome. Participants: Participants include an Endocrine Society-appointed Task Force of experts, a methodologist, and a medical writer. The European Society for Endocrinology co-sponsored the guideline. Evidence: The Task Force used the Grading of Recommendations, Assessment, Development, and Evaluation system to describe the strength of recommendations and the quality of evidence. The Task Force commissioned three systematic reviews and used the best available evidence from other published systematic reviews and individual studies. Consensus Process: The Task Force achieved consensus through one group meeting, several conference calls, and numerous e-mail communications. Committees and members of The Endocrine Society and the European Society of Endocrinology reviewed and commented on preliminary drafts of these guidelines. Conclusions: Treatment of Cushing's syndrome is essential to reduce mortality and associated comorbidities. Effective treatment includes the normalization of cortisol levels or action. It also includes the normalization of comorbidities via directly treating the cause of Cushing's syndrome and by adjunctive treatments (eg, antihypertensives). Surgical resection of the causal lesion(s) is generally the first-line approach. The choice of second-line treatments, including medication, bilateral adrenalectomy, and radiation therapy (for corticotrope tumors), must be individualized to each patient. PMID:26222757

  12. The Clinical Trials Network of the Society of Nuclear Medicine.

    PubMed

    Graham, Michael M

    2010-09-01

    The Clinical Trials Network of the Society of Nuclear Medicine was formed to provide quality assurance of both imaging and radiopharmaceutical manufacturing in clinical trials. The intention is to register and qualify a large number (>200) of sites, both in the United States and internationally, to be able to do the positron emission tomography imaging part of clinical trials. Initially, the types of trials to be supported include evaluation of novel radiopharmaceuticals and trials that use approved or experimental radiopharmaceuticals for early assessment of tumor response to novel chemotherapy agents. The Clinical Trials Network is organized into 7 committees that provide overall oversight and strategic guidance, database management, site qualification and monitoring, scanner validation, clinical site orientation, technologist education, trial design, and a manufacturer's registry. At the end of the first year, more than 200 potential clinical trial sites and more than 125 manufacturing sites have expressed interest in participating. The qualification process is well underway. Funding is being provided by 3 large pharmaceutical companies. An investigational new drug application has been obtained for F-18 fluorothymidine that is held by Society of Nuclear Medicine to allow simplification of data management during multisite trials with F-18 fluorothymidine. A second investigational new drug application is in preparation for F-18 fluoromisonidazole. A supply of oncology chest phantoms has been manufactured and have been shipped to numerous sites for scanner validation. Educational materials are being developed for the physicians, technologists, and research coordinators at the sites. This is an important initiative that is likely to help significantly expand the role of molecular imaging and will help bring the right treatment to the right patient at the right time. Copyright 2010 Elsevier Inc. All rights reserved.

  13. American Cancer Society/American Society of Clinical Oncology Breast Cancer Survivorship Care Guideline.

    PubMed

    Runowicz, Carolyn D; Leach, Corinne R; Henry, N Lynn; Henry, Karen S; Mackey, Heather T; Cowens-Alvarado, Rebecca L; Cannady, Rachel S; Pratt-Chapman, Mandi L; Edge, Stephen B; Jacobs, Linda A; Hurria, Arti; Marks, Lawrence B; LaMonte, Samuel J; Warner, Ellen; Lyman, Gary H; Ganz, Patricia A

    2016-01-01

    Answer questions and earn CME/CNE The purpose of the American Cancer Society/American Society of Clinical Oncology Breast Cancer Survivorship Care Guideline is to provide recommendations to assist primary care and other clinicians in the care of female adult survivors of breast cancer. A systematic review of the literature was conducted using PubMed through April 2015. A multidisciplinary expert workgroup with expertise in primary care, gynecology, surgical oncology, medical oncology, radiation oncology, and nursing was formed and tasked with drafting the Breast Cancer Survivorship Care Guideline. A total of 1073 articles met inclusion criteria; and, after full text review, 237 were included as the evidence base. Patients should undergo regular surveillance for breast cancer recurrence, including evaluation with a cancer-related history and physical examination, and should be screened for new primary breast cancer. Data do not support performing routine laboratory tests or imaging tests in asymptomatic patients to evaluate for breast cancer recurrence. Primary care clinicians should counsel patients about the importance of maintaining a healthy lifestyle, monitor for post-treatment symptoms that can adversely affect quality of life, and monitor for adherence to endocrine therapy. Recommendations provided in this guideline are based on current evidence in the literature and expert consensus opinion. Most of the evidence is not sufficient to warrant a strong evidence-based recommendation. Recommendations on surveillance for breast cancer recurrence, screening for second primary cancers, assessment and management of physical and psychosocial long-term and late effects of breast cancer and its treatment, health promotion, and care coordination/practice implications are made.

  14. Indian Psychiatric Society Survey on Clinical Practice Guidelines

    PubMed Central

    Grover, Sandeep; Avasthi, Ajit

    2017-01-01

    Aim: This survey aimed to assess the utility of the earlier published clinical practice guidelines (CPGs) by IPS and to understand the expectations of members of Indian Psychiatric Society from the proposed revised CPGs. In addition, the survey also evaluated the current level of practice of psychiatry in terms of availability of different investigation facilities, prescription patterns in terms of use of polypharmacy, and competence in carrying out certain nonpharmacological treatments. Methodology: An online survey was received by 3475 psychiatrist, of whom 608 (17.5%) participants completed the survey. Results: Almost all (93.8%) of the psychiatrists agreed that there should be separate CPGs for Indian setting. In terms of problems with the previous version of the CPGs, this survey shows that the previous version of guidelines was used in making clinical decisions by only one-third (31.25%) of the participating psychiatrists. The major limitations of the previous version of CPGs which were pointed out included the lack of consideration of socio-cultural issues (33.2%), lack of recommendations for many clinical situations that are encountered in clinical practice (43.15) and poor dissemination (35.2%). In terms of expectations, the membership expects the society to come up with guidelines, which are shorter in length (82.2%), has significant proportion of information in the form of tables and flow diagrams (58.7%), besides the evidence base must also take expert opinions into account (84.7%), must be circulated before adopting (88.7%), must be disseminated by displaying the same on the website (72%), and also by sending the same by E-mails (62%). Further, the membership expects the IPS to design online continuing medical education program on CPGs (54.3%). The survey also suggests that it is feasible on the part of more than two-third of the psychiatrists to monitor the metabolic parameters in routine clinical practice and carryout various nonpharmacological

  15. The Spanish Neurological Society official clinical practice guidelines in epilepsy.

    PubMed

    Mercadé Cerdá, J M; Toledo Argani, M; Mauri Llerda, J A; López Gonzalez, F J; Salas Puig, X; Sancho Rieger, J

    2016-03-01

    Previous Official Clinical Practice Guidelines (CPGs) in Epilepsy were based on expert opinions and developed by the Epilepsy Study Group of the Spanish Neurological Society (GE-SEN). The current CPG in epilepsy is based on the scientific method, which extracts recommendations from published scientific evidence. A reduction in the variability in clinical practice through standardization of medical practice has become its main function. This CPG is focused on comprehensive care for individuals affected by epilepsy as a primary and predominant symptom, regardless of the age of onset and medical policy. 1. Creation of GE-SEN neurologists working group, in collaboration with Neuropediatricians, Neurophysiologists and Neuroradiologists. 2. Identification of clinical areas to be covered: diagnosis, prognosis and treatment. 3. Search and selection of the relevant scientific evidence. 4. Formulation of recommendations based on the classification of the available scientific evidence. It contains 161 recommendations of which 57% are consensus between authors and publishers, due to an important lack of awareness in many fields of this pathology. This Epilepsy CPG formulates recommendations based on explicit scientific evidence as a result of a formal and rigorous methodology, according to the current knowledge in the pre-selected areas. This paper includes the CPG chapter dedicated to emergency situations in seizures and epilepsy, which may present as a first seizure, an unfavorable outcome in a patient with known epilepsy, or status epilepticus as the most severe manifestation. Copyright © 2013 Sociedad Española de Neurología. Published by Elsevier España, S.L.U. All rights reserved.

  16. 78 FR 20664 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-05

    ... HUMAN SERVICES Food and Drug Administration Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice AGENCY: Food and Drug Administration, HHS. ACTION: Notice of conference. SUMMARY:...

  17. HER2 Testing and Clinical Decision Making in Gastroesophageal Adenocarcinoma: Guideline From the College of American Pathologists, American Society for Clinical Pathology, and American Society of Clinical Oncology.

    PubMed

    Bartley, Angela N; Washington, Mary Kay; Ventura, Christina B; Ismaila, Nofisat; Colasacco, Carol; Benson, Al B; Carrato, Alfredo; Gulley, Margaret L; Jain, Dhanpat; Kakar, Sanjay; Mackay, Helen J; Streutker, Catherine; Tang, Laura; Troxell, Megan; Ajani, Jaffer A

    2016-12-01

    ERBB2 (erb-b2 receptor tyrosine kinase 2 or HER2) is currently the only biomarker established for selection of a specific therapy for patients with advanced gastroesophageal adenocarcinoma (GEA). However, there are no comprehensive guidelines for the assessment of HER2 in patients with GEA. To establish an evidence-based guideline for HER2 testing in patients with GEA, to formalize the algorithms for methods to improve the accuracy of HER2 testing while addressing which patients and tumor specimens are appropriate, and to provide guidance on clinical decision making. The College of American Pathologists, American Society for Clinical Pathology, and American Society of Clinical Oncology convened an expert panel to conduct a systematic review of the literature to develop an evidence-based guideline with recommendations for optimal HER2 testing in patients with GEA. The panel is proposing 11 recommendations with strong agreement from the open-comment participants. The panel recommends that tumor specimen(s) from all patients with advanced GEA, who are candidates for HER2-targeted therapy, should be assessed for HER2 status before the initiation of HER2-targeted therapy. Clinicians should offer combination chemotherapy and a HER2-targeted agent as initial therapy for all patients with HER2-positive advanced GEA. For pathologists, guidance is provided for morphologic selection of neoplastic tissue, testing algorithms, scoring methods, interpretation and reporting of results, and laboratory quality assurance. This guideline provides specific recommendations for assessment of HER2 in patients with advanced GEA while addressing pertinent technical issues and clinical implications of the results. © 2016 College of American Pathologists, American Society for Clinical Pathology, and the American Society of Clinical Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  18. 2010 Canadian Cardiovascular Society/Canadian Heart Rhythm Society Training Standards and Maintenance of Competency in Adult Clinical Cardiac Electrophysiology.

    PubMed

    Green, Martin S; Guerra, Peter G; Krahn, Andrew D

    2011-01-01

    The last guidelines on training for adult cardiac electrophysiology (EP) were published by the Canadian Cardiovascular Society in 1996. Since then, substantial changes in the knowledge and practice of EP have mandated a review of the previous guidelines by the Canadian Heart Rhythm Society, an affiliate of the Canadian Cardiovascular Society. Novel tools and techniques also now allow electrophysiologists to map and ablate increasingly complex arrhythmias previously managed with pharmacologic or device therapy. Furthermore, no formal attempt had previously been made to standardize EP training across the country. The 2010 Canadian Cardiovascular Society/Canadian Heart Rhythm Society Training Standards and Maintenance of Competency in Adult Clinical Cardiac Electrophysiology represent a consensus arrived at by panel members from both societies, as well as EP program directors across Canada and other select contributors. In describing program requirements, the technical and cognitive skills that must be acquired to meet training standards, as well as the minimum number of procedures needed in order to acquire these skills, the new guidelines provide EP program directors and committee members with a template to develop an appropriate curriculum for EP training for cardiology fellows here in Canada. Copyright © 2011 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  19. Hereditary Colorectal Cancer Syndromes: American Society of Clinical Oncology Clinical Practice Guideline Endorsement of the Familial Risk–Colorectal Cancer: European Society for Medical Oncology Clinical Practice Guidelines

    PubMed Central

    Stoffel, Elena M.; Mangu, Pamela B.; Gruber, Stephen B.; Hamilton, Stanley R.; Kalady, Matthew F.; Lau, Michelle Wan Yee; Lu, Karen H.; Roach, Nancy; Limburg, Paul J.

    2015-01-01

    Purpose To provide recommendations on prevention, screening, genetics, treatment, and management for people at risk for hereditary colorectal cancer (CRC) syndromes. The American Society of Clinical Oncology (ASCO) has a policy and set of procedures for endorsing clinical practice guidelines that have been developed by other professional organizations. Methods The Familial Risk–Colorectal Cancer: European Society for Medical Oncology Clinical Practice Guideline published in 2013 on behalf of the European Society for Medical Oncology (ESMO) Guidelines Working Group in Annals of Oncology was reviewed for developmental rigor by methodologists, with content and recommendations reviewed by an ASCO endorsement panel. Results The ASCO endorsement panel determined that the recommendations of the ESMO guidelines are clear, thorough, and based on the most relevant scientific evidence. The ASCO panel endorsed the ESMO guidelines and added a few qualifying statements. Recommendations Approximately 5% to 6% of patient cases of CRC are associated with germline mutations that confer an inherited predisposition for cancer. The possibility of a hereditary cancer syndrome should be assessed for every patient at the time of CRC diagnosis. A diagnosis of Lynch syndrome, familial adenomatous polyposis, or another genetic syndrome can influence clinical management for patients with CRC and their family members. Screening for hereditary cancer syndromes in patients with CRC should include review of personal and family histories and testing of tumors for DNA mismatch repair deficiency and/or microsatellite instability. Formal genetic evaluation is recommended for individuals who meet defined criteria. PMID:25452455

  20. Japanese Society of Clinical Oncology clinical practice guidelines 2010 for antiemesis in oncology: executive summary.

    PubMed

    Takeuchi, Hideki; Saeki, Toshiaki; Aiba, Keisuke; Tamura, Kazuo; Aogi, Kenjiro; Eguchi, Kenji; Okita, Kenji; Kagami, Yoshikazu; Tanaka, Ryuhei; Nakagawa, Kazuhiko; Fujii, Hirofumi; Boku, Narikazu; Wada, Makoto; Akechi, Tatsuo; Udagawa, Yasuhiro; Okawa, Yutaka; Onozawa, Yusuke; Sasaki, Hidenori; Shima, Yasuo; Shimoyama, Naohito; Takeda, Masayuki; Nishidate, Toshihiko; Yamamoto, Akifumi; Ikeda, Tadashi; Hirata, Koichi

    2016-02-01

    The purpose of this article is to disseminate the standard of antiemetic therapy for Japanese clinical oncologists. On the basis of the Appraisal of Guidelines for Research and Evaluation II instrument, which reflects evidence-based clinical practice guidelines, a working group of the Japanese Society of Clinical Oncology (JSCO) reviewed clinical practice guidelines for antiemesis and performed a systematic review of evidence-based domestic practice guidelines for antiemetic therapy in Japan. In addition, because health-insurance systems in Japan are different from those in other countries, a consensus was reached regarding standard treatments for chemotherapy that induce nausea and vomiting. Current evidence was collected by use of MEDLINE, from materials from meetings of the American Society of Clinical Oncology National Comprehensive Cancer Network, and from European Society of Medical Oncology/Multinational Association of Supportive Care in Cancer guidelines for antiemesis. Initially, 21 clinical questions (CQ) were selected on the basis of CQs from other guidelines. Patients treated with highly emetic agents should receive a serotonin (5-hydroxytryptamine; 5HT3) receptor antagonist, dexamethasone, and a neurokinin 1 receptor antagonist. For patients with moderate emetic risk, 5HT3 receptor antagonists and dexamethasone were recommended, whereas for those receiving chemotherapy with low emetic risk dexamethasone only is recommended. Patients receiving high-emetic-risk radiation therapy should also receive a 5HT3 receptor antagonist. In this paper the 2010 JSCO clinical practice guidelines for antiemesis are presented in English; they reveal high concordance of Japanese medical circumstances with other antiemetic guidelines that are similarly based on evidence.

  1. What does a clinically-scientific professional society stand for?

    PubMed Central

    Gerris, J; Ombelet, W

    2016-01-01

    Abstract Originated as a mainly social group of befriended colleagues, the VVOG has evolved over the past 55 years to become a truly professional society facing successfully such diverse challenges as organizing scientific congresses, postgraduate training, ethical debates, hands-on training courses, social events, interactions with national and international sister societies but also with the industry, insurers, the government, politicians and patient organisations. PMID:27909563

  2. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer.

    PubMed

    Saslow, Debbie; Solomon, Diane; Lawson, Herschel W; Killackey, Maureen; Kulasingam, Shalini L; Cain, Joanna M; Garcia, Francisco A R; Moriarty, Ann T; Waxman, Alan G; Wilbur, David C; Wentzensen, Nicolas; Downs, Levi S; Spitzer, Mark; Moscicki, Anna-Barbara; Franco, Eduardo L; Stoler, Mark H; Schiffman, Mark; Castle, Philip E; Myers, Evan R; Chelmow, David; Herzig, Abbe; Kim, Jane J; Kinney, Walter; Herschel, W Lawson; Waldman, Jeffrey

    2012-07-01

    An update to the American Cancer Society (ACS) guideline regarding screening for the early detection of cervical precancerous lesions and cancer is presented. The guidelines are based on a systematic evidence review, contributions from six working groups, and a recent symposium co-sponsored by the ACS, American Society for Colposcopy and Cervical Pathology (ASCCP), and American Society for Clinical Pathology (ASCP), which was attended by 25 organizations. The new screening recommendations address age-appropriate screening strategies, including the use of cytology and high-risk human papillomavirus (HPV) testing, follow-up (e.g., management of screen positives and screening interval for screen negatives) of women after screening, age at which to exit screening, future considerations regarding HPV testing alone as a primary screening approach, and screening strategies for women vaccinated against HPV16/18 infections.

  3. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer.

    PubMed

    Saslow, Debbie; Solomon, Diane; Lawson, Herschel W; Killackey, Maureen; Kulasingam, Shalini L; Cain, Joanna; Garcia, Francisco A R; Moriarty, Ann T; Waxman, Alan G; Wilbur, David C; Wentzensen, Nicolas; Downs, Levi S; Spitzer, Mark; Moscicki, Anna-Barbara; Franco, Eduardo L; Stoler, Mark H; Schiffman, Mark; Castle, Philip E; Myers, Evan R

    2012-01-01

    An update to the American Cancer Society (ACS) guideline regarding screening for the early detection of cervical precancerous lesions and cancer is presented. The guidelines are based on a systematic evidence review, contributions from 6 working groups, and a recent symposium cosponsored by the ACS, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology, which was attended by 25 organizations. The new screening recommendations address age-appropriate screening strategies, including the use of cytology and high-risk human papillomavirus (HPV) testing, follow-up (eg, the management of screen positives and screening intervals for screen negatives) of women after screening, the age at which to exit screening, future considerations regarding HPV testing alone as a primary screening approach, and screening strategies for women vaccinated against HPV16 and HPV18 infections.

  4. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer.

    PubMed

    Saslow, Debbie; Solomon, Diane; Lawson, Herschel W; Killackey, Maureen; Kulasingam, Shalini L; Cain, Joanna; Garcia, Francisco A R; Moriarty, Ann T; Waxman, Alan G; Wilbur, David C; Wentzensen, Nicolas; Downs, Levi S; Spitzer, Mark; Moscicki, Anna-Barbara; Franco, Eduardo L; Stoler, Mark H; Schiffman, Mark; Castle, Philip E; Myers, Evan R

    2012-04-01

    An update to the American Cancer Society (ACS) guideline regarding screening for the early detection of cervical precancerous lesions and cancer is presented. The guidelines are based on a systematic evidence review, contributions from 6 working groups, and a recent symposium cosponsored by the ACS, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology, which was attended by 25 organizations. The new screening recommendations address age-appropriate screening strategies, including the use of cytology and high-risk human papillomavirus (HPV) testing, follow-up (eg, the management of screen positives and screening intervals for screen negatives) of women after screening, the age at which to exit screening, future considerations regarding HPV testing alone as a primary screening approach, and screening strategies for women vaccinated against HPV16 and HPV18 infections.

  5. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology Screening Guidelines for the Prevention and Early Detection of Cervical Cancer

    PubMed Central

    Saslow, Debbie; Solomon, Diane; Lawson, Herschel W.; Killackey, Maureen; Kulasingam, Shalini; Cain, Joanna; Garcia, Francisco A. R.; Moriarty, Ann; Waxman, Alan; Wilbur, David; Wentzensen, Nicolas; Downs, Levi; Spitzer, Mark; Moscicki, Anna-Barbara; Saraiya, Mona; Franco, Eduardo L.; Stoler, Mark H.; Schiffman, Mark; Castle, Philip E.; Myers, Evan R.

    2013-01-01

    An update to the American Cancer Society (ACS) guideline regarding screening for the early detection of cervical precancerous lesions and cancer is presented. The guidelines are based on a systematic evidence review, contributions from six working groups, and a recent symposium co-sponsored by the ACS, American Society for Colposcopy and Cervical Pathology (ASCCP), and American Society for Clinical Pathology (ASCP), which was attended by 25 organizations. The new screening recommendations address age-appropriate screening strategies, including the use of cytology and high-risk human papillomavirus (HPV) testing, follow-up (e.g., management of screen positives and screening interval for screen negatives) of women after screening, age at which to exit screening, future considerations regarding HPV testing alone as a primary screening approach, and screening strategies for women vaccinated against HPV16 and HPV18 infections. PMID:22418039

  6. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology Screening Guidelines for the Prevention and Early Detection of Cervical Cancer

    PubMed Central

    Saslow, Debbie; Solomon, Diane; Lawson, Herschel W.; Killackey, Maureen; Kulasingam, Shalini; Cain, Joanna; Garcia, Francisco A. R.; Moriarty, Ann; Waxman, Alan; Wilbur, David; Wentzensen, Nicolas; Downs, Levi; Spitzer, Mark; Moscicki, Anna-Barbara; Franco, Eduardo L.; Stoler, Mark H.; Schiffman, Mark; Castle, Philip E.; Myers, Evan R.

    2013-01-01

    An update to the American Cancer Society (ACS) guideline regarding screening for the early detection of cervical precancerous lesions and cancer is presented. The guidelines are based on a systematic evidence review, contributions from six working groups, and a recent symposium cosponsored by the ACS, American Society for Colposcopy and Cervical Pathology (ASCCP), and American Society for Clinical Pathology (ASCP), which was attended by 25 organizations. The new screening recommendations address age-appropriate screening strategies, including the use of cytology and high-risk human papillomavirus (HPV) testing, follow-up (e.g., management of screen positives and screening interval for screen negatives) of women after screening, age at which to exit screening, future considerations regarding HPV testing alone as a primary screening approach, and screening strategies for women vaccinated against HPV16 and HPV18 infections. PMID:22422631

  7. Adjuvant and salvage radiotherapy after prostatectomy: American Society of Clinical Oncology clinical practice guideline endorsement.

    PubMed

    Freedland, Stephen J; Rumble, R Bryan; Finelli, Antonio; Chen, Ronald C; Slovin, Susan; Stein, Mark N; Mendelson, David S; Wackett, Colin; Sandler, Howard M

    2014-12-01

    To endorse the American Urological Association (AUA)/American Society for Radiation Oncology (ASTRO) guideline on adjuvant and salvage radiotherapy after prostatectomy. The American Society of Clinical Oncology (ASCO) has a policy and set of procedures for endorsing clinical practice guidelines developed by other professional organizations. The guideline on adjuvant and salvage radiotherapy after prostatectomy was reviewed for developmental rigor by methodologists. An ASCO endorsement panel then reviewed the content and recommendations. The panel determined that the guideline recommendations on adjuvant and salvage radiotherapy after prostatectomy, published in August 2013, are clear, thorough, and based on the most relevant scientific evidence. ASCO endorsed the guideline on adjuvant and salvage radiotherapy after prostatectomy, adding one qualifying statement that not all candidates for adjuvant or salvage radiotherapy have the same risk of recurrence or disease progression, and thus, risk-benefit ratios are not the same for all men. Those at the highest risk for recurrence after radical prostatectomy include men with seminal vesicle invasion, Gleason score 8 to 10, extensive positive margins, and detectable postoperative prostate-specific antigen (PSA). Physicians should discuss adjuvant radiotherapy with patients with adverse pathologic findings at prostatectomy (ie, seminal vesicle invasion, positive surgical margins, extraprostatic extension) and salvage radiotherapy with patients with PSA or local recurrence after prostatectomy. The discussion of radiotherapy should include possible short- and long-term adverse effects and potential benefits. The decision to administer radiotherapy should be made by the patient and multidisciplinary treatment team, keeping in mind that not all men are at equal risk of recurrence or clinically meaningful disease progression. Thus, the risk-benefit ratio will differ for each patient. © 2014 by American Society of Clinical

  8. American Society of Clinical Oncology clinical practice guidelines: opportunities and challenges.

    PubMed

    Somerfield, Mark R; Einhaus, Kaitlin; Hagerty, Karen L; Brouwers, Melissa C; Seidenfeld, Jerome; Lyman, Gary H

    2008-08-20

    The American Society of Clinical Oncology (ASCO) published its first clinical practice guideline, which focused on the use of hematopoietic colony-stimulating factors, in 1994. Since then, ASCO has published 24 additional guidelines or technology assessments on a range of topics and is developing 11 additional guidelines. Guidelines are among ASCO's most valued products, according to membership surveys and data from the JCO.org Web site. However, the same data from ASCO members have highlighted a number of limitations to the guideline program. These relate to the timelines of guideline updates, difficulties locating guidelines and related products, and challenges to implementing ASCO guidelines in everyday clinical practice. This article outlines the concrete steps that the ASCO Health Services Committee (HSC) is taking to address these limitations, including the institution of a more aggressive guideline updating schedule, a transition from narrative to systematic literature reviews to support the practice recommendations, a new Board of Directors-approved policy to permit endorsement of other groups' guidelines, and a robust Clinical Tools and Resources program that offers a range of guideline dissemination and implementation aids. Additional work is underway to establish stronger and deeper collaborations with practicing oncologists to expand their role in the review, field testing, and implementation of guideline clinical tools and resources. Finally, the HSC is discussing evaluation of the guidelines program to maximize the impact of ASCO clinical practice guidelines on clinical decision making and, ultimately, the quality of cancer care.

  9. Report of the results of the International Clinical Cytometry Society and American Society for Clinical Pathology workload survey of clinical flow cytometry laboratories.

    PubMed

    Wolniak, Kristy; Goolsby, Charles; Choi, Sarah; Ali, Asma; Serdy, Nina; Stetler-Stevenson, Maryalice

    2016-07-01

    Thorough review of current workload, staffing, and testing practices in clinical laboratories allows for optimization of laboratory efficiency and quality. This information is largely missing with regard to clinical flow cytometry laboratories. The purpose of this survey is to provide comprehensive, current, and accurate data on testing practices and laboratory staffing in clinical laboratories performing flow cytometric studies. Survey data was collected from flow cytometry laboratories through the ASCP website. Data was collected on the workload during a 1-year time period of full-time and part-time technical and professional (M.D./D.O./Ph.D. or equivalent) flow cytometry employees. Workload was examined as number of specimens and tubes per full time equivalent (FTE) technical and professional staff. Test complexity, test result interpretation, and reporting practices were also evaluated. There were 205 respondent laboratories affiliated predominantly with academic and health system institutions. Overall, 1,132 FTE employees were reported with 29% professional FTE employees and 71% technical. Fifty-one percent of the testing performed was considered high complexity and 49% was low complexity. The average number of tubes per FTE technologist was 1,194 per year and the average number of specimens per FTE professional was 1,659 per year. The flow cytometry reports were predominantly written by pathologists (57%) and were typically written as a separate report (58%). This survey evaluates the overall status of the current practice of clinical flow cytometry and provides a comprehensive dataset as a framework to help laboratory departments, directors, and managers make appropriate, cost-effective staffing decisions. © 2016 International Clinical Cytometry Society. © 2016 International Clinical Cytometry Society.

  10. Postmastectomy Radiotherapy: An American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Focused Guideline Update.

    PubMed

    Recht, Abram; Comen, Elizabeth A; Fine, Richard E; Fleming, Gini F; Hardenbergh, Patricia H; Ho, Alice Y; Hudis, Clifford A; Hwang, E Shelley; Kirshner, Jeffrey J; Morrow, Monica; Salerno, Kilian E; Sledge, George W; Solin, Lawrence J; Spears, Patricia A; Whelan, Timothy J; Somerfield, Mark R; Edge, Stephen B

    2016-12-20

    Purpose A joint American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology panel convened to develop a focused update of the American Society of Clinical Oncology guideline concerning use of postmastectomy radiotherapy (PMRT). Methods A recent systematic literature review by Cancer Care Ontario provided the primary evidentiary basis. The joint panel also reviewed targeted literature searches to identify new, potentially practice-changing data. Recommendations The panel unanimously agreed that available evidence shows that PMRT reduces the risks of locoregional failure (LRF), any recurrence, and breast cancer mortality for patients with T1-2 breast cancer with one to three positive axillary nodes. However, some subsets of these patients are likely to have such a low risk of LRF that the absolute benefit of PMRT is outweighed by its potential toxicities. In addition, the acceptable ratio of benefit to toxicity varies among patients and physicians. Thus, the decision to recommend PMRT requires a great deal of clinical judgment. The panel agreed clinicians making such recommendations for individual patients should consider factors that may decrease the risk of LRF, attenuate the benefit of reduced breast cancer-specific mortality, and/or increase risk of complications resulting from PMRT. When clinicians and patients elect to omit axillary dissection after a positive sentinel node biopsy, the panel recommends that these patients receive PMRT only if there is already sufficient information to justify its use without needing to know additional axillary nodes are involved. Patients with axillary nodal involvement after neoadjuvant systemic therapy should receive PMRT. The panel recommends treatment generally be administered to both the internal mammary nodes and the supraclavicular-axillary apical nodes in addition to the chest wall or reconstructed breast.

  11. HER2 Testing and Clinical Decision Making in Gastroesophageal Adenocarcinoma: Guideline From the College of American Pathologists, American Society for Clinical Pathology, and American Society of Clinical Oncology.

    PubMed

    Bartley, Angela N; Washington, Mary Kay; Ventura, Christina B; Ismaila, Nofisat; Colasacco, Carol; Benson, Al B; Carrato, Alfredo; Gulley, Margaret L; Jain, Dhanpat; Kakar, Sanjay; Mackay, Helen J; Streutker, Catherine; Tang, Laura; Troxell, Megan; Ajani, Jaffer A

    2016-12-01

    - ERBB2 (erb-b2 receptor tyrosine kinase 2 or HER2) is currently the only biomarker established for selection of a specific therapy for patients with advanced gastroesophageal adenocarcinoma (GEA). However, there are no comprehensive guidelines for the assessment of HER2 in patients with GEA. - To establish an evidence-based guideline for HER2 testing in patients with GEA, to formalize the algorithms for methods to improve the accuracy of HER2 testing while addressing which patients and tumor specimens are appropriate, and to provide guidance on clinical decision making. - The College of American Pathologists, American Society for Clinical Pathology, and American Society of Clinical Oncology convened an expert panel to conduct a systematic review of the literature to develop an evidence-based guideline with recommendations for optimal HER2 testing in patients with GEA. - The panel is proposing 11 recommendations with strong agreement from the open-comment participants. - The panel recommends that tumor specimen(s) from all patients with advanced GEA, who are candidates for HER2-targeted therapy, should be assessed for HER2 status before the initiation of HER2-targeted therapy. Clinicians should offer combination chemotherapy and a HER2-targeted agent as initial therapy for all patients with HER2-positive advanced GEA. For pathologists, guidance is provided for morphologic selection of neoplastic tissue, testing algorithms, scoring methods, interpretation and reporting of results, and laboratory quality assurance. - This guideline provides specific recommendations for assessment of HER2 in patients with advanced GEA while addressing pertinent technical issues and clinical implications of the results.

  12. American Clinical Neurophysiology Society Guideline 7: Guidelines for EEG Reporting.

    PubMed

    Tatum, William O; Olga, Selioutski; Ochoa, Juan G; Munger Clary, Heidi; Cheek, Janna; Drislane, Frank; Tsuchida, Tammy N

    2016-08-01

    This EEG Guideline incorporates the practice of structuring a report of results obtained during routine adult electroencephalography. It is intended to reflect one of the current practices in reporting an EEG and serves as a revision of the previous guideline entitled "Writing an EEG Report." The goal of this guideline is not only to convey clinically relevant information, but also to improve interrater reliability for clinical and research use by standardizing the format of EEG reports. With this in mind, there is expanded documentation of the patient history to include more relevant clinical information that can affect the EEG recording and interpretation. Recommendations for the technical conditions of the recording are also enhanced to include post hoc review parameters and type of EEG recording. Sleep feature documentation is also expanded upon. More descriptive terms are included for background features and interictal discharges that are concordant with efforts to standardize terminology. In the clinical correlation section, examples of common clinical scenarios are now provided that encourages uniformity in reporting. Including digital samples of abnormal waveforms is now readily available with current EEG recording systems and may be beneficial in augmenting reports when controversial waveforms or important features are encountered.

  13. Home mechanical ventilation: a Canadian Thoracic Society clinical practice guideline.

    PubMed

    McKim, Douglas A; Road, Jeremy; Avendano, Monica; Abdool, Steve; Cote, Fabien; Duguid, Nigel; Fraser, Janet; Maltais, Fracois; Morrison, Debra L; O'Connell, Colleen; Petrof, Basil J; Rimmer, Karen; Skomro, Robert

    2011-01-01

    Increasing numbers of patients are surviving episodes of prolonged mechanical ventilation or benefitting from the recent availability of userfriendly noninvasive ventilators. Although many publications pertaining to specific aspects of home mechanical ventilation (HMV) exist, very few comprehensive guidelines that bring together all of the current literature on patients at risk for or using mechanical ventilatory support are available. The Canadian Thoracic Society HMV Guideline Committee has reviewed the available English literature on topics related to HMV in adults, and completed a detailed guideline that will help standardize and improve the assessment and management of individuals requiring noninvasive or invasive HMV. The guideline provides a disease-specific review of illnesses including amyotrophic lateral sclerosis, spinal cord injury, muscular dystrophies, myotonic dystrophy, kyphoscoliosis, post-polio syndrome, central hypoventilation syndrome, obesity hypoventilation syndrome, and chronic obstructive pulmonary disease as well as important common themes such as airway clearance and the process of transition to home. The guidelines have been extensively reviewed by international experts, allied health professionals and target audiences. They will be updated on a regular basis to incorporate any new information.

  14. When a man encounters a woman, Satan is also present: clinical relationships in Bedouin society.

    PubMed

    Mass, M; al-Krenawi, A

    1994-07-01

    Professional encounters in Bedouin society between male therapists and their female clients are discussed in terms of the conflict between clinical precepts and Bedouin codes of social conduct. The effects of the conflict on the transference relationship are examined by means of case presentations, and rules of conduct acceptable in both the professional realm and Bedouin society are proposed as an avenue toward resolution.

  15. [25 years of clinical psychology of the East German Society of Psychology].

    PubMed

    Göth, N

    1988-02-01

    In the 25. year of existing of Section Clinical Psychology of society for Psychology in the GDR are analysed the todays performance, educational points and developments. The very young history of clinical Psychology is demonstrating the value of clinical Psychologist in the socialistic healthy work and the international important positions of special education to psychological specialist of medicine. The analysis of last years is showing stronger a interweave from clinical Psychology and clinical medicine.

  16. Summary of the Updated American Geriatrics Society/British Geriatrics Society clinical practice guideline for prevention of falls in older persons.

    PubMed

    2011-01-01

    The following article is a summary of the American Geriatrics Society/British Geriatrics Society Clinical Practice Guideline for Prevention of Falls in Older Persons (2010). This article provides additional discussion of the guideline process and the differences between the current guideline and the 2001 version and includes the guidelines' recommendations, algorithm, and acknowledgments. The complete guideline is published on the American Geriatrics Society's Web site (http://www.americangeriatrics.org/health_care_professionals/clinical_practice/clinical_guidelines_recommendations/2010/). © 2011, Copyright the Authors. Journal compilation © 2011, The American Geriatrics Society.

  17. Potentially Curable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update.

    PubMed

    Khorana, Alok A; Mangu, Pamela B; Berlin, Jordan; Engebretson, Anitra; Hong, Theodore S; Maitra, Anirban; Mohile, Supriya G; Mumber, Matthew; Schulick, Richard; Shapiro, Marc; Urba, Susan; Zeh, Herbert J; Katz, Matthew H G

    2017-04-11

    Purpose To update the Potentially Curable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline published on May 31, 2016. The October 2016 update focuses solely on new evidence that pertains to clinical question 4 of the guideline: What is the appropriate adjuvant regimen for patients with pancreatic cancer who have undergone an R0 or R1 resection of their primary tumor? Methods The recently published results of a randomized phase III study prompted an update of this guideline. The high quality of the reported evidence and the potential for its clinical impact prompted the Expert Panel to revise one of the guideline recommendations. Results The ESPAC-4 study, a multicenter, international, open-label randomized controlled phase III trial of adjuvant combination chemotherapy compared gemcitabine and capecitabine with gemcitabine monotherapy in 730 evaluable patients with resected pancreatic ductal adenocarcinoma. Median overall survival was improved in the doublet arm to 28.0 months (95% CI, 23.5 to 31.5 months) versus 25.5 months (95% CI, 22.7 to 27.9 months) for gemcitabine alone (hazard ratio, 0.82; 95% CI, 0.68 to 0.98; P = .032). Grade 3 and 4 adverse events were similar in both arms, although higher rates of hand-foot syndrome and diarrhea occurred in patients randomly assigned to the doublet arm. Recommendations All patients with resected pancreatic cancer who did not receive preoperative therapy should be offered 6 months of adjuvant chemotherapy in the absence of medical or surgical contraindications. The doublet regimen of gemcitabine and capecitabine is preferred in the absence of concerns for toxicity or tolerance; alternatively, monotherapy with gemcitabine or fluorouracil plus folinic acid can be offered. Adjuvant treatment should be initiated within 8 weeks of surgical resection, assuming complete recovery. The remaining recommendations from the original 2016 ASCO guideline are unchanged.

  18. Pituitary Incidentaloma: An Endocrine Society Clinical Practice Guideline

    PubMed Central

    Freda, Pamela U.; Beckers, Albert M.; Katznelson, Laurence; Molitch, Mark E.; Montori, Victor M.; Post, Kalmon D.; Vance, Mary Lee

    2011-01-01

    Objective: The aim was to formulate practice guidelines for endocrine evaluation and treatment of pituitary incidentalomas. Consensus Process: Consensus was guided by systematic reviews of evidence and discussions through a series of conference calls and e-mails and one in-person meeting. Conclusions: We recommend that patients with a pituitary incidentaloma undergo a complete history and physical examination, laboratory evaluations screening for hormone hypersecretion and for hypopituitarism, and a visual field examination if the lesion abuts the optic nerves or chiasm. We recommend that patients with incidentalomas not meeting criteria for surgical removal be followed with clinical assessments, neuroimaging (magnetic resonance imaging at 6 months for macroincidentalomas, 1 yr for a microincidentaloma, and thereafter progressively less frequently if unchanged in size), visual field examinations for incidentalomas that abut or compress the optic nerve and chiasm (6 months and yearly), and endocrine testing for macroincidentalomas (6 months and yearly) after the initial evaluations. We recommend that patients with a pituitary incidentaloma be referred for surgery if they have a visual field deficit; signs of compression by the tumor leading to other visual abnormalities, such as ophthalmoplegia, or neurological compromise due to compression by the lesion; a lesion abutting the optic nerves or chiasm; pituitary apoplexy with visual disturbance; or if the incidentaloma is a hypersecreting tumor other than a prolactinoma. PMID:21474686

  19. Fertility preservation for patients with cancer: American Society of Clinical Oncology clinical practice guideline update.

    PubMed

    Loren, Alison W; Mangu, Pamela B; Beck, Lindsay Nohr; Brennan, Lawrence; Magdalinski, Anthony J; Partridge, Ann H; Quinn, Gwendolyn; Wallace, W Hamish; Oktay, Kutluk

    2013-07-01

    To update guidance for health care providers about fertility preservation for adults and children with cancer. A systematic review of the literature published from March 2006 through January 2013 was completed using MEDLINE and the Cochrane Collaboration Library. An Update Panel reviewed the evidence and updated the recommendation language. There were 222 new publications that met inclusion criteria. A majority were observational studies, cohort studies, and case series or reports, with few randomized clinical trials. After review of the new evidence, the Update Panel concluded that no major, substantive revisions to the 2006 American Society of Clinical Oncology recommendations were warranted, but clarifications were added. As part of education and informed consent before cancer therapy, health care providers (including medical oncologists, radiation oncologists, gynecologic oncologists, urologists, hematologists, pediatric oncologists, and surgeons) should address the possibility of infertility with patients treated during their reproductive years (or with parents or guardians of children) and be prepared to discuss fertility preservation options and/or to refer all potential patients to appropriate reproductive specialists. Although patients may be focused initially on their cancer diagnosis, the Update Panel encourages providers to advise patients regarding potential threats to fertility as early as possible in the treatment process so as to allow for the widest array of options for fertility preservation. The discussion should be documented. Sperm and embryo cryopreservation as well as oocyte cryopreservation are considered standard practice and are widely available. Other fertility preservation methods should be considered investigational and should be performed by providers with the necessary expertise.

  20. American Society of Clinical Oncology policy statement: oversight of clinical research.

    PubMed

    2003-06-15

    Well-publicized lapses in the review or implementation of clinical research studies have raised public questions about the integrity of the clinical research process. Public trust in the integrity of research is critical not only for funding and participation in clinical trials but also for confidence in the treatments that result from the trials. The questions raised by these unfortunate cases pose an important opportunity to reassess the clinical trials oversight system to ensure the integrity of clinical research and the safety of those who enroll in clinical trials. Since its inception, the American Society of Clinical Oncology (ASCO) has worked for the advancement of cancer treatments through clinical research and to help patients gain prompt access to scientifically excellent and ethically unimpeachable clinical trials. As an extension of its mission, ASCO is affirming with this policy statement the critical importance of a robust review and oversight system to ensure that clinical trials participants give fully informed consent and that their safety is a top priority. Ensuring the integrity of research cannot be stressed enough because of its seminal connection to the advancement of clinical cancer treatment. The overall goal of this policy is to enhance public trust in the cancer clinical trials process. To achieve this, the following elements are essential: 1. Ensure safety precautions for clinical trial participants and their fully informed consent. 2. Ensure the validity and integrity of scientific research. 3. Enhance the educational training of clinical scientists and research staff to ensure the highest standards of research conduct. 4. Promote accountability and responsibility among all those involved in clinical research (not just those serving on institutional review boards [IRBs], but also institutional officials, researchers, sponsors, and participants) and ensure support for an effective oversight process. 5. Enhance the professional and public

  1. Parent-Adolescent Cross-Informant Agreement in Clinically Referred Samples: Findings From Seven Societies.

    PubMed

    Rescorla, Leslie A; Ewing, Grace; Ivanova, Masha Y; Aebi, Marcel; Bilenberg, Niels; Dieleman, Gwen C; Döpfner, Manfred; Kajokiene, Ilona; Leung, Patrick W L; Plück, Julia; Steinhausen, Hans-Christoph; Winkler Metzke, Christa; Zukauskiene, Rita; Verhulst, Frank C

    2017-01-01

    To conduct international comparisons of parent-adolescent cross-informant agreement in clinical samples, we analyzed ratings on the Child Behavior Checklist (CBCL) and Youth Self-Report (YSR) for 6,762 clinically referred adolescents ages 11-18 from 7 societies (M = 14.5 years, SD = 2.0 years; 51% boys). Using CBCL and YSR data, we asked the following questions: (a) Do parents report more problems for their adolescent children than the adolescents report about themselves? (b) How do cross-informant correlations (rs) for scale scores differ by problem type and by society? (c) How well do parents and adolescents, on average, agree regarding which problems they rate as low, medium, or high? (d) How does within-dyad item agreement vary within and between societies? (e) How do societies vary in dichotomous cross-informant agreement with respect to the deviance status of the adolescents? CBCL and YSR scores were quite similar, with small and inconsistent informant effects across societies. Cross-informant rs averaged .47 across scales and societies. On average, parents and adolescents agreed well regarding which problem items received low, medium, or high ratings (M r = .87). Mean within-dyad item agreement was moderate across all societies, but dyadic agreement varied widely within every society. In most societies, adolescent noncorroboration of parent-reported deviance was more common than parental noncorroboration of adolescent-reported deviance. Overall, somewhat better parent-adolescent agreement and more consistency in agreement patterns across diverse societies were found in these seven clinical samples than in population samples studied using the same methods.

  2. Comparative Evaluation of American Cancer Society and American Lung Association Smoking Cessation Clinics.

    ERIC Educational Resources Information Center

    Lando, Harry A.; And Others

    1990-01-01

    Compared the effectiveness of the American Cancer Society's "FreshStart," the American Lung Association's "Freedom from Smoking," and a laboratory smoking cessation clinic. A one-year followup favored the more intensive laboratory and "Freedom from Smoking" clinics over the "FreshStart" method. (FMW)

  3. Comparative Evaluation of American Cancer Society and American Lung Association Smoking Cessation Clinics.

    ERIC Educational Resources Information Center

    Lando, Harry A.; And Others

    1990-01-01

    Compared the effectiveness of the American Cancer Society's "FreshStart," the American Lung Association's "Freedom from Smoking," and a laboratory smoking cessation clinic. A one-year followup favored the more intensive laboratory and "Freedom from Smoking" clinics over the "FreshStart" method. (FMW)

  4. Neoadjuvant Chemotherapy for Newly Diagnosed, Advanced Ovarian Cancer: Society of Gynecologic Oncology and American Society of Clinical Oncology Clinical Practice Guideline.

    PubMed

    Wright, Alexi A; Bohlke, Kari; Armstrong, Deborah K; Bookman, Michael A; Cliby, William A; Coleman, Robert L; Dizon, Don S; Kash, Joseph J; Meyer, Larissa A; Moore, Kathleen N; Olawaiye, Alexander B; Oldham, Jessica; Salani, Ritu; Sparacio, Dee; Tew, William P; Vergote, Ignace; Edelson, Mitchell I

    2016-10-01

    To provide guidance to clinicians regarding the use of neoadjuvant chemotherapy and interval cytoreduction among women with stage IIIC or IV epithelial ovarian cancer. The Society of Gynecologic Oncology and the American Society of Clinical Oncology convened an Expert Panel and conducted a systematic review of the literature. Four phase III clinical trials form the primary evidence base for the recommendations. The published studies suggest that for selected women with stage IIIC or IV epithelial ovarian cancer, neoadjuvant chemotherapy and interval cytoreduction are noninferior to primary cytoreduction and adjuvant chemotherapy with respect to overall and progression-free survival and are associated with less perioperative morbidity and mortality. All women with suspected stage IIIC or IV invasive epithelial ovarian cancer should be evaluated by a gynecologic oncologist prior to initiation of therapy. The primary clinical evaluation should include a CT of the abdomen and pelvis, and chest imaging (CT preferred). Women with a high perioperative risk profile or a low likelihood of achieving cytoreduction to < 1 cm of residual disease (ideally to no visible disease) should receive neoadjuvant chemotherapy. Women who are fit for primary cytoreductive surgery, and with potentially resectable disease, may receive either neoadjuvant chemotherapy or primary cytoreductive surgery. However, primary cytoreductive surgery is preferred if there is a high likelihood of achieving cytoreduction to < 1 cm (ideally to no visible disease) with acceptable morbidity. Before neoadjuvant chemotherapy is delivered, all patients should have confirmation of an invasive ovarian, fallopian tube, or peritoneal cancer. Additional information is available at www.asco.org/NACT-ovarian-guideline and www.asco.org/guidelineswiki. © 2016 Society of Gynecologic Oncology and American Society of Clinical Oncology.

  5. Cost consideration in the clinical guidance documents of physician specialty societies in the United States.

    PubMed

    Schwartz, Jennifer A T; Pearson, Steven D

    2013-06-24

    Despite increasing concerns regarding the cost of health care, the consideration of costs in the development of clinical guidance documents by physician specialty societies has received little analysis. To evaluate the approach to consideration of cost in publicly available clinical guidance documents and methodological statements produced between 2008 and 2012 by the 30 largest US physician specialty societies. Qualitative document review. Whether costs are considered in clinical guidance development, mechanism of cost consideration, and the way that cost issues were used in support of specific clinical practice recommendations. Methodological statements for clinical guidance documents indicated that 17 of 30 physician societies (57%) explicitly integrated costs, 4 (13%) implicitly considered costs, 3 (10%) intentionally excluded costs, and 6 (20%) made no mention. Of the 17 societies that explicitly integrated costs, 9 (53%) consistently used a formal system in which the strength of recommendation was influenced in part by costs, whereas 8 (47%) were inconsistent in their approach or failed to mention the exact mechanism for considering costs. Among the 138 specific recommendations in these guidance documents that included cost as part of the rationale, the most common form of recommendation (50 [36%]) encouraged the use of a specific medical service because of equal effectiveness and lower cost. Slightly more than half of the largest US physician societies explicitly consider costs in developing their clinical guidance documents; among these, approximately half use an explicit mechanism for integrating costs into the strength of recommendations. Many societies remain vague in their approach. Physician specialty societies should demonstrate greater transparency and rigor in their approach to cost consideration in documents meant to influence care decisions.

  6. Fertility Preservation for Patients With Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update

    PubMed Central

    Loren, Alison W.; Mangu, Pamela B.; Beck, Lindsay Nohr; Brennan, Lawrence; Magdalinski, Anthony J.; Partridge, Ann H.; Quinn, Gwendolyn; Wallace, W. Hamish; Oktay, Kutluk

    2013-01-01

    Purpose To update guidance for health care providers about fertility preservation for adults and children with cancer. Methods A systematic review of the literature published from March 2006 through January 2013 was completed using MEDLINE and the Cochrane Collaboration Library. An Update Panel reviewed the evidence and updated the recommendation language. Results There were 222 new publications that met inclusion criteria. A majority were observational studies, cohort studies, and case series or reports, with few randomized clinical trials. After review of the new evidence, the Update Panel concluded that no major, substantive revisions to the 2006 American Society of Clinical Oncology recommendations were warranted, but clarifications were added. Recommendations As part of education and informed consent before cancer therapy, health care providers (including medical oncologists, radiation oncologists, gynecologic oncologists, urologists, hematologists, pediatric oncologists, and surgeons) should address the possibility of infertility with patients treated during their reproductive years (or with parents or guardians of children) and be prepared to discuss fertility preservation options and/or to refer all potential patients to appropriate reproductive specialists. Although patients may be focused initially on their cancer diagnosis, the Update Panel encourages providers to advise patients regarding potential threats to fertility as early as possible in the treatment process so as to allow for the widest array of options for fertility preservation. The discussion should be documented. Sperm and embryo cryopreservation as well as oocyte cryopreservation are considered standard practice and are widely available. Other fertility preservation methods should be considered investigational and should be performed by providers with the necessary expertise. PMID:23715580

  7. Metastatic Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline

    PubMed Central

    Sohal, Davendra P.S.; Mangu, Pamela B.; Khorana, Alok A.; Shah, Manish A.; Philip, Philip A.; O’Reilly, Eileen M.; Uronis, Hope E.; Ramanathan, Ramesh K.; Crane, Christopher H.; Engebretson, Anitra; Ruggiero, Joseph T.; Copur, Mehmet S.; Lau, Michelle; Urba, Susan; Laheru, Daniel

    2016-01-01

    Purpose To provide evidence-based recommendations to oncologists and others for the treatment of patients with metastatic pancreatic cancer. Methods American Society of Clinical Oncology convened an Expert Panel of medical oncology, radiation oncology, surgical oncology, gastroenterology, palliative care, and advocacy experts to conduct a systematic review of the literature from April 2004 to June 2015. Outcomes were overall survival, disease-free survival, progression-free survival, and adverse events. Results Twenty-four randomized controlled trials met the systematic review criteria. Recommendations A multiphase computed tomography scan of the chest, abdomen, and pelvis should be performed. Baseline performance status and comorbidity profile should be evaluated. Goals of care, patient preferences, treatment response, psychological status, support systems, and symptom burden should guide decisions for treatments. A palliative care referral should occur at first visit. FOLFIRINOX (leucovorin, fluorouracil, irinotecan, and oxaliplatin; favorable comorbidity profile) or gemcitabine plus nanoparticle albumin-bound (NAB) -paclitaxel (adequate comorbidity profile) should be offered to patients with Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1 based on patient preference and support system available. Gemcitabine alone is recommended for patients with ECOG PS 2 or with a comorbidity profile that precludes other regimens; the addition of capecitabine or erlotinib may be offered. Patients with an ECOG PS ≥ 3 and poorly controlled comorbid conditions should be offered cancer-directed therapy only on a case-by-case basis; supportive care should be emphasized. For second-line therapy, gemcitabine plus NAB-paclitaxel should be offered to patients with first-line treatment with FOLFIRINOX, an ECOG PS 0 to 1, and a favorable comorbidity profile; fluorouracil plus oxaliplatin, irinotecan, or nanoliposomal irinotecan should be offered to patients with

  8. Maintaining Life-saving Testing for Patients With Infectious Diseases: Infectious Diseases Society of America, American Society for Microbiology, and Pan American Society for Clinical Virology Recommendations on the Regulation of Laboratory-developed Tests.

    PubMed

    Caliendo, Angela M; Couturier, Marc R; Ginocchio, Christine C; Hanson, Kimberly E; Miller, Melissa B; Walker, Kimberly E; Frank, Gregory M

    2016-07-15

    In 2014, the US Food and Drug Administration (FDA) proposed to regulate laboratory-developed tests (LDTs)-diagnostics designed, manufactured, and used within a single laboratory. The Infectious Diseases Society of America, the American Society for Microbiology, and the Pan American Society for Clinical Virology recognize that the FDA is committed to protecting patients. However, our societies are concerned that the proposed regulations will limit access to testing and negatively impact infectious diseases (ID) LDTs. In this joint commentary, our societies discuss why LDTs are critical for ID patient care, hospital infection control, and public health responses. We also highlight how the FDA's proposed regulation of LDTs could impair patient access to life-saving tests and stifle innovation in ID diagnostics. Finally, our societies make specific recommendations for the FDA's consideration to reduce the burden of the proposed new rules on clinical laboratories and protect patients' access to state-of-the art, quality LDTs.

  9. International Society on Thrombosis and Haemostasis core curriculum project: core competencies in clinical thrombosis and hemostasis.

    PubMed

    McLintock, C; Pabinger, I; Bauer, K A; Laffan, M; Angchaisuksiri, P; Rezende, S M; Middeldorp, S; Ross, M

    2016-01-01

    Essentials The priority of ISTH was to establish a global core curriculum in thrombosis and hemostasis. International survey to determine competencies required for clinical specialists was carried out in the field. Competency framework provides a reference point for mapping and developing regional curricula. Core curriculum informs and links to a variety of ISTH educational materials. Background The International Society on Thrombosis and Haemostasis (ISTH) identified the need for an international core curriculum on thrombosis and hemostasis for its society members and the larger thrombosis and hemostasis community. Aims The current research sought consensus on the core competencies required by medical doctors who are ready to practise as independent clinical specialists in thrombosis and hemostasis with the aim of developing a core clinical curriculum for specialists in the field. Method A draft list of competencies was developed by the Working Group and formed the basis of an online survey. ISTH members and the larger thrombosis and hemostasis community were asked to rate the importance of each competency, on a Likert scale, for clinical specialists in thrombosis and hemostasis. Results There were a total of 644 responses to the online survey with broad geographical representation. There was general agreement on what level of competency would be required for clinical specialists in thrombosis and hemostasis at the specified level of training. Conclusions Using the survey to gain consensus on the level of competency required by clinical specialists in the field of thrombosis and hemostasis enabled the development of a core clinical curriculum that has been endorsed by the ISTH Council. The curriculum will offer a framework and international reference that will be used by the society, by national and regional organizations, and for further research. © 2015 International Society on Thrombosis and Haemostasis.

  10. Inside the 2016 American Society of Clinical Oncology Genitourinary Cancers Symposium: part 1 - kidney cancer.

    PubMed

    Buti, Sebastiano; Ciccarese, Chiara; Iacovelli, Roberto; Bersanelli, Melissa; Scarpelli, Marina; Lopez-Beltran, Antonio; Cheng, Liang; Montironi, Rodolfo; Tortora, Giampaolo; Massari, Francesco

    2016-09-01

    The American Society of Clinical Oncology Genitourinary Cancers Symposium, Moscone West Building, San Francisco, CA, USA, 7-9 January 2016 The American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, held in San Francisco (CA, USA), from 7 to 9 January 2016, focused on 'patient-centric care: translating research to results'. Every year, this meeting is a must for anyone studying genitourinary tumors to keep abreast of the most recent innovations in this field, exchange views on behaviors customarily adopted in daily clinical practice, and discuss future topics of scientific research. This two-part report highlights the key themes presented at the 2016 ASCO Genitourinary Cancers Symposium, with part 1 reporting the main novelties of kidney cancer and part 2 discussing the most relevant issues which have emerged for bladder and prostate tumors.

  11. Clinical diagnosis of progressive supranuclear palsy: The movement disorder society criteria.

    PubMed

    Höglinger, Günter U; Respondek, Gesine; Stamelou, Maria; Kurz, Carolin; Josephs, Keith A; Lang, Anthony E; Mollenhauer, Brit; Müller, Ulrich; Nilsson, Christer; Whitwell, Jennifer L; Arzberger, Thomas; Englund, Elisabet; Gelpi, Ellen; Giese, Armin; Irwin, David J; Meissner, Wassilios G; Pantelyat, Alexander; Rajput, Alex; van Swieten, John C; Troakes, Claire; Antonini, Angelo; Bhatia, Kailash P; Bordelon, Yvette; Compta, Yaroslau; Corvol, Jean-Christophe; Colosimo, Carlo; Dickson, Dennis W; Dodel, Richard; Ferguson, Leslie; Grossman, Murray; Kassubek, Jan; Krismer, Florian; Levin, Johannes; Lorenzl, Stefan; Morris, Huw R; Nestor, Peter; Oertel, Wolfgang H; Poewe, Werner; Rabinovici, Gil; Rowe, James B; Schellenberg, Gerard D; Seppi, Klaus; van Eimeren, Thilo; Wenning, Gregor K; Boxer, Adam L; Golbe, Lawrence I; Litvan, Irene

    2017-06-01

    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. We aimed to provide an evidence- and consensus-based revision of the clinical diagnostic criteria for PSP. 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. 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. Here, we present new criteria aimed to optimize early, sensitive, and specific clinical diagnosis of PSP on the basis of currently available evidence. © 2017 International Parkinson and Movement Disorder Society. © 2017 International Parkinson and Movement Disorder Society.

  12. Neoadjuvant chemotherapy for newly diagnosed, advanced ovarian cancer: Society of Gynecologic Oncology and American Society of Clinical Oncology Clinical Practice Guideline.

    PubMed

    Wright, Alexi A; Bohlke, Kari; Armstrong, Deborah K; Bookman, Michael A; Cliby, William A; Coleman, Robert L; Dizon, Don S; Kash, Joseph J; Meyer, Larissa A; Moore, Kathleen N; Olawaiye, Alexander B; Oldham, Jessica; Salani, Ritu; Sparacio, Dee; Tew, William P; Vergote, Ignace; Edelson, Mitchell I

    2016-10-01

    To provide guidance to clinicians regarding the use of neoadjuvant chemotherapy and interval cytoreduction among women with stage IIIC or IV epithelial ovarian cancer. The Society of Gynecologic Oncology and the American Society of Clinical Oncology convened an Expert Panel and conducted a systematic review of the literature. Four phase III clinical trials form the primary evidence base for the recommendations. The published studies suggest that for selected women with stage IIIC or IV epithelial ovarian cancer, neoadjuvant chemotherapy and interval cytoreduction are non-inferior to primary cytoreduction and adjuvant chemotherapy with respect to overall and progression-free survival and are associated with less perioperative morbidity and mortality. All women with suspected stage IIIC or IV invasive epithelial ovarian cancer should be evaluated by a gynecologic oncologist prior to initiation of therapy. The primary clinical evaluation should include a CT of the abdomen and pelvis, and chest imaging (CT preferred). Women with a high perioperative risk profile or a low likelihood of achieving cytoreduction to <1cm of residual disease (ideally to no visible disease) should receive neoadjuvant chemotherapy. Women who are fit for primary cytoreductive surgery, and with potentially resectable disease, may receive either neoadjuvant chemotherapy or primary cytoreductive surgery. However, primary cytoreductive surgery is preferred if there is a high likelihood of achieving cytoreduction to <1cm (ideally to no visible disease) with acceptable morbidity. Before neoadjuvant chemotherapy is delivered, all patients should have confirmation of an invasive ovarian, fallopian tube, or peritoneal cancer. Additional information is available at www.asco.org/NACT-ovarian-guideline and www.asco.org/guidelineswiki. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  13. [Clinical and therapeutic management of respiratory tract infections. Consensus document of the Andalusian Infectious Diseases Society and the Andalusian Family and Community Medicine Society].

    PubMed

    Cordero Matía, Elisa; de Dios Alcántara Bellón, Juan; Caballero Granado, Javier; de la Torre Lima, Javier; Girón González, José Antonio; Lama Herrera, Carmen; Morán Rodríguez, Ana; Zapata López, Angel

    2007-04-01

    Respiratory tract infections are frequent and they are one of the commonest causes of antibiotic prescription. However, there are few clinical guidelines that consider this group of infections. This document has been written by the Andalusian Infectious Diseases Society and the Andalusian Family and Community Medicine Society. The primary objective has been to define the recommendations for the diagnosis and antibiotic treatment of respiratory tract infections apart from pneumonia. The clinical syndromes evaluated have been: a) pharyngitis; b) sinusitis; c) acute otitis media and otitis externa; d) acute bronchitis, laryngitis, epiglottitis; e) acute exacerbation of chronic bronchitis; and f) respiratory infectious in patients with bronchiectasis. This document has focused on immunocompetent patients.

  14. The Diagnosis of Cushing's Syndrome: An Endocrine Society Clinical Practice Guideline

    PubMed Central

    Nieman, Lynnette K.; Biller, Beverly M. K.; Findling, James W.; Newell-Price, John; Savage, Martin O.; Stewart, Paul M.; Montori, Victor M.

    2008-01-01

    Objective: The objective of the study was to develop clinical practice guidelines for the diagnosis of Cushing's syndrome. Participants: The Task Force included a chair, selected by the Clinical Guidelines Subcommittee (CGS) of The Endocrine Society, five additional experts, a methodologist, and a medical writer. The Task Force received no corporate funding or remuneration. Consensus Process: Consensus was guided by systematic reviews of evidence and discussions. The guidelines were reviewed and approved sequentially by The Endocrine Society's CGS and Clinical Affairs Core Committee, members responding to a web posting, and The Endocrine Society Council. At each stage the Task Force incorporated needed changes in response to written comments. Conclusions: After excluding exogenous glucocorticoid use, we recommend testing for Cushing's syndrome in patients with multiple and progressive features compatible with the syndrome, particularly those with a high discriminatory value, and patients with adrenal incidentaloma. We recommend initial use of one test with high diagnostic accuracy (urine cortisol, late night salivary cortisol, 1 mg overnight or 2 mg 48-h dexamethasone suppression test). We recommend that patients with an abnormal result see an endocrinologist and undergo a second test, either one of the above or, in some cases, a serum midnight cortisol or dexamethasone-CRH test. Patients with concordant abnormal results should undergo testing for the cause of Cushing's syndrome. Patients with concordant normal results should not undergo further evaluation. We recommend additional testing in patients with discordant results, normal responses suspected of cyclic hypercortisolism, or initially normal responses who accumulate additional features over time. PMID:18334580

  15. An analysis of the American Cancer Society Clinical Research Training program.

    PubMed

    Vogler, William R

    2004-01-01

    In 1996 the American Cancer Society initiated a Clinical Research Training Grant for junior investigators. This was a 3-year mentored grant for preclinical and clinical research training. Two hundred four individuals applied from 103 institutions, and 25% were funded. This report is an initial assessment of the impact of the program on future career development. Both the funded and unfunded groups were queried regarding prior research experience, publications, and academic status. Although small differences were seen between the funded and unfunded groups, the major finding was that those applicants with prior research and publication experience were more likely to get funded, but both groups were highly motivated to seek an academic career.

  16. The "Commitment Model" for Clinical Ethics Consultations: Society's Involvement in the Solution of Individual Cases.

    PubMed

    Fournier, Véronique; Spranzi, Marta; Foureur, Nicolas; Brunet, Laurence

    2015-01-01

    Several approaches to clinical ethics consultation (CEC) exist in medical practice and are widely discussed in the clinical ethics literature; different models of CECs are classified according to their methods, goals, and consultant's attitude. Although the "facilitation" model has been endorsed by the American Society for Bioethics and Humanities (ASBH) and is described in an influential manual, alternative approaches, such as advocacy, moral expertise, mediation, and engagement are practiced and defended in the clinical ethics field. Our Clinical Ethics Center in Paris was founded in 2002 in the wake of the Patients' Rights Act, and to date it is the largest center that provides consultation services in France. In this article we shall describe and defend our own approach to clinical ethics consultation, which we call the "Commitment Model," in comparison with other existing models. Indeed commitment implies, among other meanings, continuity through time, a series of coherent actions, and the realization of important social goals. By drawing on a recent consultation case, we shall describe the main steps of our consultation procedure: interviews with major stakeholders, including patients and proxies; case conferences; and follow up. We shall show why we have chosen the term "commitment" to represent our approach at three different but interrelated levels: commitment towards patients, within the case conference group, and towards society as a whole.

  17. Executive summary of the 2013 International Society for Clinical Densitometry Position Development Conference on Body Composition.

    PubMed

    Shepherd, John A; Baim, Sanford; Bilezikian, John P; Schousboe, John T

    2013-01-01

    There have been many scientific advances in measurement of fat and lean body mass as determined by dual-energy X-ray absorptiometry (DXA). The International Society for Clinical Densitometry (ISCD) convened a Position Development Conference (PDC) on the use of DXA for body composition measurement. Previously, no guidelines to the use of DXA for body composition existed. The recommendations pertain to clinically relevant issues regarding DXA indications of use, acquisition, analysis, quality control, interpretation, and reporting were addressed. The topics and questions for consideration were developed by the ISCD Board of Directors and the Scientific Advisory Committee and were designed to address the needs of clinical practitioners. Three Task Forces were created and assigned these questions and asked to conduct comprehensive literature reviews. The Task Forces included participants from 6 countries and a variety of interests including academic institutions, private clinics, and industry. Reports with proposed Position Statements were then presented to an international panel of experts with backgrounds in DXA and bone densitometry and a variety of fields that use body composition measures. The PDC was held in Tampa, FL, contemporaneously with the Annual Meeting of the ISCD, March 21 through March 23, 2013. This report describes the methodology of the 2013 ISCD Body Composition PDC and summarizes the results. Three separate articles in this issue will detail the rationale, discussion, and additional research topics for each question the Task Forces addressed. Copyright © 2013 The International Society for Clinical Densitometry. Published by Elsevier Inc. All rights reserved.

  18. Clinical Practice Guidelines for Pancreatic Cancer 2016 From the Japan Pancreas Society: A Synopsis.

    PubMed

    Yamaguchi, Koji; Okusaka, Takuji; Shimizu, Kyoko; Furuse, Junji; Ito, Yoshinori; Hanada, Keiji; Shimosegawa, Tooru; Okazaki, Kazuichi

    Clinical Practice Guidelines for Pancreatic Cancer based on Evidence-Based Medicine 2006 were first published by the Japan Pancreas Society, and they were revised to Clinical Practice Guidelines for Pancreatic Cancer 2009 in July 2009 and were further revised to Clinical Practice Guidelines for Pancreatic Cancer 2013 in October 2013. These guidelines were established according to evidence-based medicine. In October 2016, the Clinical Practice Guidelines for Pancreatic Cancer were newly revised in Japanese. In the revised version, we introduced the concepts of GRADE - grading recommendations assessment, development, and evaluation approach for better understanding of the current guidelines. The guidelines show algorithms for the diagnosis, treatment, and chemotherapy of pancreatic cancer and address 7 subjects: diagnosis, surgical therapy, adjuvant therapy, radiation therapy, chemotherapy, stent therapy, and palliative medicine. They include 51 clinical questions and 76 statements. There are statements corresponding to clinical questions, evidence levels, recommended strengths, and agreement rates. These guidelines represent the most standard clinical and practical management at this time in Japan. This is the English synopsis of the Clinical Practice Guidelines for Pancreatic Cancer 2016 in Japanese, which aims to disseminate the Japanese guidelines worldwide for the introduction of Japanese clinical management of these diseases.

  19. Clinical Anatomy of the Liver: Review of the 19th Meeting of the Japanese Research Society of Clinical Anatomy

    PubMed Central

    Sakamoto, Yoshihiro; Kokudo, Norihiro; Kawaguchi, Yoshikuni; Akita, Keiichi

    2017-01-01

    Precise clinical knowledge of liver anatomy is required to safely perform a hepatectomy, for both open and laparoscopic surgery. At the 19th meeting of the Japanese Research Society of Clinical Anatomy (JRSCA), we conducted special symposia on essential issues of liver surgery, such as the history of hepatic segmentation, the glissonean pedicle approach, application of 3-D imaging simulation and fluorescent imaging using indocyanine green solution, a variety of segmentectomies including caudate lobectomy, the associating liver partition and portal vein embolization for stage hepatectomy and harvesting liver grafts for living donor liver transplantation. The present review article provides useful information for liver surgeons and anatomic researchers. PMID:28275581

  20. American Society of Hematology/American Society of Clinical Oncology clinical practice guideline update on the use of epoetin and darbepoetin in adult patients with cancer.

    PubMed

    Rizzo, J Douglas; Brouwers, Melissa; Hurley, Patricia; Seidenfeld, Jerome; Arcasoy, Murat O; Spivak, Jerry L; Bennett, Charles L; Bohlius, Julia; Evanchuk, Darren; Goode, Matthew J; Jakubowski, Ann A; Regan, David H; Somerfield, Mark R

    2010-11-18

    To update American Society of Hematology/American Society of Clinical Oncology recommendations for use of erythropoiesis-stimulating agents (ESAs) in patients with cancer. An Update Committee reviewed data published between January 2007 and January 2010. MEDLINE and the Cochrane Library were searched. The literature search yielded one new individual patient data analysis and four literature-based meta-analyses, two systematic reviews, and 13 publications reporting new results from randomized controlled trials not included in prior or new reviews. For patients undergoing myelosuppressive chemotherapy who have a hemoglobin (Hb) level less than 10 g/dL, the Update Committee recommends that clinicians discuss potential harms (eg, thromboembolism, shorter survival) and benefits (eg, decreased transfusions) of ESAs and compare these with potential harms (eg, serious infections, immune-mediated adverse reactions) and benefits (eg, rapid Hb improvement) of RBC transfusions. Individual preferences for assumed risk should contribute to shared decisions on managing chemotherapy-induced anemia. The Committee cautions against ESA use under other circumstances. If used, ESAs should be administered at the lowest dose possible and should increase Hb to the lowest concentration possible to avoid transfusions. Available evidence does not identify Hb levels ≥ 10 g/dL either as thresholds for initiating treatment or as targets for ESA therapy. Starting doses and dose modifications after response or nonresponse should follow US Food and Drug Administration-approved labeling. ESAs should be discontinued after 6 to 8 weeks in nonresponders. ESAs should be avoided in patients with cancer not receiving concurrent chemotherapy, except for those with lower risk myelodysplastic syndromes. Caution should be exercised when using ESAs with chemotherapeutic agents in diseases associated with increased risk of thromboembolic complications. Table 1 lists detailed recommendations.

  1. American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update on the use of epoetin and darbepoetin in adult patients with cancer.

    PubMed

    Rizzo, J Douglas; Brouwers, Melissa; Hurley, Patricia; Seidenfeld, Jerome; Arcasoy, Murat O; Spivak, Jerry L; Bennett, Charles L; Bohlius, Julia; Evanchuk, Darren; Goode, Matthew J; Jakubowski, Ann A; Regan, David H; Somerfield, Mark R

    2010-11-20

    To update American Society of Clinical Oncology/American Society of Hematology recommendations for use of erythropoiesis-stimulating agents (ESAs) in patients with cancer. An Update Committee reviewed data published between January 2007 and January 2010. MEDLINE and the Cochrane Library were searched. The literature search yielded one new individual patient data analysis and four literature-based meta-analyses, two systematic reviews, and 13 publications reporting new results from randomized controlled trials not included in prior or new reviews. For patients undergoing myelosuppressive chemotherapy who have a hemoglobin (Hb) level less than 10 g/dL, the Update Committee recommends that clinicians discuss potential harms (eg, thromboembolism, shorter survival) and benefits (eg, decreased transfusions) of ESAs and compare these with potential harms (eg, serious infections, immune-mediated adverse reactions) and benefits (eg, rapid Hb improvement) of RBC transfusions. Individual preferences for assumed risk should contribute to shared decisions on managing chemotherapy-induced anemia. The Committee cautions against ESA use under other circumstances. If used, ESAs should be administered at the lowest dose possible and should increase Hb to the lowest concentration possible to avoid transfusions. Available evidence does not identify Hb levels ≥ 10 g/dL either as thresholds for initiating treatment or as targets for ESA therapy. Starting doses and dose modifications after response or nonresponse should follow US Food and Drug Administration-approved labeling. ESAs should be discontinued after 6 to 8 weeks in nonresponders. ESAs should be avoided in patients with cancer not receiving concurrent chemotherapy, except for those with lower risk myelodysplastic syndromes. Caution should be exercised when using ESAs with chemotherapeutic agents in diseases associated with increased risk of thromboembolic complications. Table 1 lists detailed recommendations.

  2. Diagnosis and Treatment of Primary Adrenal Insufficiency: An Endocrine Society Clinical Practice Guideline

    PubMed Central

    Bornstein, Stefan R.; Allolio, Bruno; Arlt, Wiebke; Barthel, Andreas; Don-Wauchope, Andrew; Hammer, Gary D.; Husebye, Eystein S.; Merke, Deborah P.; Murad, M. Hassan; Stratakis, Constantine A.; Torpy, David J.

    2016-01-01

    Objective: This clinical practice guideline addresses the diagnosis and treatment of primary adrenal insufficiency. Participants: The Task Force included a chair, selected by The Clinical Guidelines Subcommittee of the Endocrine Society, eight additional clinicians experienced with the disease, a methodologist, and a medical writer. The co-sponsoring associations (European Society of Endocrinology and the American Association for Clinical Chemistry) had participating members. The Task Force received no corporate funding or remuneration in connection with this review. Evidence: This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to determine the strength of recommendations and the quality of evidence. Consensus Process: The evidence used to formulate recommendations was derived from two commissioned systematic reviews as well as other published systematic reviews and studies identified by the Task Force. The guideline was reviewed and approved sequentially by the Endocrine Society's Clinical Guidelines Subcommittee and Clinical Affairs Core Committee, members responding to a web posting, and the Endocrine Society Council. At each stage, the Task Force incorporated changes in response to written comments. Conclusions: We recommend diagnostic tests for the exclusion of primary adrenal insufficiency in all patients with indicative clinical symptoms or signs. In particular, we suggest a low diagnostic (and therapeutic) threshold in acutely ill patients, as well as in patients with predisposing factors. This is also recommended for pregnant women with unexplained persistent nausea, fatigue, and hypotension. We recommend a short corticotropin test (250 μg) as the “gold standard” diagnostic tool to establish the diagnosis. If a short corticotropin test is not possible in the first instance, we recommend an initial screening procedure comprising the measurement of morning plasma ACTH

  3. Diagnosis and Treatment of Primary Adrenal Insufficiency: An Endocrine Society Clinical Practice Guideline.

    PubMed

    Bornstein, Stefan R; Allolio, Bruno; Arlt, Wiebke; Barthel, Andreas; Don-Wauchope, Andrew; Hammer, Gary D; Husebye, Eystein S; Merke, Deborah P; Murad, M Hassan; Stratakis, Constantine A; Torpy, David J

    2016-02-01

    This clinical practice guideline addresses the diagnosis and treatment of primary adrenal insufficiency. The Task Force included a chair, selected by The Clinical Guidelines Subcommittee of the Endocrine Society, eight additional clinicians experienced with the disease, a methodologist, and a medical writer. The co-sponsoring associations (European Society of Endocrinology and the American Association for Clinical Chemistry) had participating members. The Task Force received no corporate funding or remuneration in connection with this review. This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to determine the strength of recommendations and the quality of evidence. The evidence used to formulate recommendations was derived from two commissioned systematic reviews as well as other published systematic reviews and studies identified by the Task Force. The guideline was reviewed and approved sequentially by the Endocrine Society's Clinical Guidelines Subcommittee and Clinical Affairs Core Committee, members responding to a web posting, and the Endocrine Society Council. At each stage, the Task Force incorporated changes in response to written comments. We recommend diagnostic tests for the exclusion of primary adrenal insufficiency in all patients with indicative clinical symptoms or signs. In particular, we suggest a low diagnostic (and therapeutic) threshold in acutely ill patients, as well as in patients with predisposing factors. This is also recommended for pregnant women with unexplained persistent nausea, fatigue, and hypotension. We recommend a short corticotropin test (250 μg) as the "gold standard" diagnostic tool to establish the diagnosis. If a short corticotropin test is not possible in the first instance, we recommend an initial screening procedure comprising the measurement of morning plasma ACTH and cortisol levels. Diagnosis of the underlying cause should include a

  4. Quality Assessment of Clinical Practice Guidelines Developed by Professional Societies in Turkey.

    PubMed

    Yaşar, Ilknur; Kahveci, Rabia; Baydar Artantaş, Aylin; Ayhan Başer, Duygu; Gökşin Cihan, Fatma; Şencan, Irfan; Koç, Esra Meltem; Özkara, Adem

    2016-01-01

    Clinical practice guidelines (CPGs) are systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances. There is a limited number of studies on guidelines in Turkey. The quality of Ministry of Health guidelines have formerly been assessed whereas there is no information on the other guidelines developed in the country. This study aims to assess the quality of CPGs that are developed by professional societies that work for the health sector in Turkey, and compare the findings with international guidelines. Professional societies that work for the health sector were determined by using the data obtained from the Ministry of Internal Affairs. Inclusion and exclusion criteria were defined for selecting the CPGs. Guidelines containing recommendations about disease management to the doctors, accessible online, developed within the past 5 years, citing references for recommendations, about the diseases over 1% prevalence according to the "Statistical Yearbook of Turkey 2012" were included in the study. The quality of CPGs were assessed with the AGREE II instrument, which is an internationally recognized tool for this purpose. Four independent reviewers, who did not participate in the development of the selected guidelines and were trained in CPG appraisal, used the AGREE instrument for assessment of the selected guidelines. 47 professional societies were defined which provided access to CPGs in their websites; 3 of them were only open to members so these could not be reached. 8 CPGs from 7 societies were selected from a total of 401 CPGs from 44 societies. The mean scores of the domains of the guidelines which were assessed by the AGREE II tool were; 64%, stakeholder involvement: 37.9%, rigour of development: 35.3%, clarity and presentation: 77.9%, applicability: 49.0% and editorial independence: 46.0%. This is the first study in Turkey regarding quality appraisal of guidelines developed by

  5. American Society of Clinical Oncology Policy Statement on Clinical Pathways in Oncology.

    PubMed

    Zon, Robin T; Frame, James N; Neuss, Michael N; Page, Ray D; Wollins, Dana S; Stranne, Steven; Bosserman, Linda D

    2016-03-01

    The use of clinical pathways in oncology care is increasingly important to patients and oncology providers as a tool for enhancing both quality and value. However, with increasing adoption of pathways into oncology practice, concerns have been raised by ASCO members and other stakeholders. These include the process being used for pathway development, the administrative burdens on oncology practices of reporting on pathway adherence, and understanding the true impact of pathway use on patient health outcomes. To address these concerns, ASCO's Board of Directors established a Task Force on Clinical Pathways, charged with articulating a set of recommendations to improve the development of oncology pathways and processes, allowing the demonstration of pathway concordance in a manner that promotes evidence-based, high-value care respecting input from patients, payers, and providers. These recommendations have been approved and adopted by ASCO's Board of Directors on August 12, 2015, and are presented herein.

  6. Head and Neck Cancer Survivorship Care Guideline: American Society of Clinical Oncology Clinical Practice Guideline Endorsement of the American Cancer Society Guideline.

    PubMed

    Nekhlyudov, Larissa; Lacchetti, Christina; Davis, Nancy B; Garvey, Thomas Q; Goldstein, David P; Nunnink, J Chris; Ninfea, Jose I Ruades; Salner, Andrew L; Salz, Talya; Siu, Lillian L

    2017-02-27

    Purpose This guideline provides recommendations on the management of adults after head and neck cancer (HNC) treatment, focusing on surveillance and screening for recurrence or second primary cancers, assessment and management of long-term and late effects, health promotion, care coordination, and practice implications. Methods ASCO has a policy and set of procedures for endorsing clinical practice guidelines that have been developed by other professional organizations. The American Cancer Society (ACS) HNC Survivorship Care Guideline was reviewed for developmental rigor by methodologists. An ASCO Expert Panel reviewed the content and recommendations, offering modifications and/or qualifying statements when deemed necessary. Results The ASCO Expert Panel determined that the ACS HNC Survivorship Care Guideline, published in 2016, is clear, thorough, clinically practical, and helpful, despite the limited availability of high-quality evidence to support many of the recommendations. ASCO endorsed the ACS HNC Survivorship Care Guideline, adding qualifying statements aimed at promoting team-based, multispecialty, multidisciplinary, collaborative head and neck survivorship care. Recommendations The ASCO Expert Panel emphasized that caring for HNC survivors requires a team-based approach that includes primary care clinicians, oncology specialists, otolaryngologists, dentists, and other allied professionals. The HNC treatment team should educate the primary care clinicians and patients about the type(s) of treatment received, the likelihood of potential recurrence, and the potential late and long-term complications. Primary care clinicians should recognize symptoms of recurrence and coordinate a prompt evaluation. They should also be prepared to manage late effects either directly or by referral to appropriate specialists. Health promotion is critical, particularly regarding tobacco cessation and dental care. Additional information is available at www

  7. The Canadian Society of Clinical Chemists: highlights of its first 50 years.

    PubMed

    Crowe, Arlene J

    2006-05-01

    This article has been written to mark the 50th anniversary of the Canadian Society of Clinical Chemists (CSCC). It is not an exhaustive history of CSCC's activities but rather a review of many of the highlights that the Society and its members have experienced since its founding in October 1956. The names of many members who made important contributions to CSCC's development (but by no means all) are mentioned in the text. The historical material is presented by the decade but with blurred boundaries, as noteworthy advances in CSCC's history have most often developed gradually over several years and the terms of office of several CSCC Councils. From a founding roster of slightly over 70 members, the membership has grown to several hundred. The two main objectives for the Society's founding were stated by one of the three Montrealers who extended the original invitation, Dr. William S. Bauld: "to raise the standards of performance, and to raise the professional standing of clinical chemists". The early reports of committees on Instrumentation, Methods and Quality Control had rapid impact on individual members' laboratory practices across the country. The struggle for recognition of clinical chemists by other health professions inside and outside the clinical laboratories has taken much longer and has consisted of a long series of incremental successes through certification by examination, training programs, continuing education and, ultimately, the formation in 1986 of the Canadian Academy of Clinical Biochemistry. The CSCC's means of intra- and inter-communication with external organizations consist of its newsletter CSCC News, its scientific journal Clinical Biochemistry (established in 1967), and its more recently created website www.cscc.ca (1997). These three mechanisms ensure exchange of information between the officers of CSCC Council and the general membership and among members as well. National and international conferences have offered the newest

  8. American brachytherapy society recommendations for clinical implementation of NIST-1999 standards for (103)palladium brachytherapy. The clinical research committee of the American Brachytherapy Society.

    PubMed

    Beyer, D; Nath, R; Butler, W; Merrick, G; Blasko, J; Nag, S; Orton, C

    2000-05-01

    Recent important developments in palladium-103 ((103)Pd) dosimetry mandate a reevaluation of (103)Pd brachytherapy prescribing practices. The clinical research committee of the American Brachytherapy Society (ABS) convened a consensus session of brachytherapists and physicists to develop recommendations regarding future dose prescribing guidelines for National Institute of Standards and Technology (NIST-1999) calibrated (103)Pd sources. The ABS recommends that clinicians attempt to reproduce the implant doses delivered and reported in the literature through the past decade. The following should be immediately implemented for (103)Pd dosimetry: 1) All practicing physicians, physicists, dosimetrists, and suppliers implement NIST-1999 air-kerma strength standard for (103)Pd brachytherapy. 2) All treatment planning systems and dose calculation algorithms must be updated to reflect new dose rate constants. The AAPM-recommended validated value for Theraseed model 200 is 0.665 cGy h(-1) U(-1). The dose rate constant for the Mentor MED3633 seed is currently reported as 0.68 cGy h(-1) U(-1). This latter value and the values for seeds from other manufacturers are awaiting independent confirmation. 3) Physicians who previously prescribed 115 Gy for (103)Pd monotherapy prostate implants should now prescribe 125 Gy. When using (103)Pd as a boost following 45 Gy of external beam irradiation, 100 Gy should be prescribed instead of the previous 90 Gy. It is critical that all three changes be implemented concurrently, because they are interdependent.

  9. Setting high-impact clinical research priorities for the Society for Vascular Surgery.

    PubMed

    Kraiss, Larry W; Conte, Michael S; Geary, Randolph L; Kibbe, Melina; Ozaki, C Keith

    2013-02-01

    With the overall goal of enhancing the effectiveness and efficiency of vascular care, the Society for Vascular Surgery (SVS) recently completed a process by which it identified its top clinical research priorities to address critical gaps in knowledge guiding practitioners in prevention and treatment of vascular disease. After a survey of the SVS membership, a panel of SVS committee members and opinion leaders considered 53 distinct research questions through a structured process that resulted in identification of nine clinical issues that were felt to merit immediate attention by vascular investigators and external funding agencies. These are, in order of priority: (1) define optimal management of asymptomatic carotid stenosis, (2) compare the effectiveness of medical vs invasive treatment (open or endovascular) of vasculogenic claudication, (3) compare effectiveness of open vs endovascular infrainguinal revascularization as initial treatment of critical limb ischemia, (4) develop and compare the effectiveness of clinical strategies to reduce cardiovascular and other perioperative complications (eg, wound) after vascular intervention, (5) compare the effectiveness of strategies to enhance arteriovenous fistula maturation and durability, (6) develop best practices for management of chronic venous ulcer, (7) define optimal adjunctive medical therapy to enhance the success of lower extremity revascularization, (8) identify and evaluate medical therapy to prevent abdominal aortic aneurysm growth, and (9) evaluate ultrasound vs computed tomographic angiography surveillance after endovascular aneurysm repair. Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

  10. Evaluation and Treatment of Hypertriglyceridemia: An Endocrine Society Clinical Practice Guideline

    PubMed Central

    Berglund, Lars; Brunzell, John D.; Goldberg, Anne C.; Goldberg, Ira J.; Sacks, Frank; Murad, Mohammad Hassan; Stalenhoef, Anton F. H.

    2012-01-01

    Objective: The aim was to develop clinical practice guidelines on hypertriglyceridemia. Participants: The Task Force included a chair selected by The Endocrine Society Clinical Guidelines Subcommittee (CGS), five additional experts in the field, and a methodologist. The authors received no corporate funding or remuneration. Consensus Process: Consensus was guided by systematic reviews of evidence, e-mail discussion, conference calls, and one in-person meeting. The guidelines were reviewed and approved sequentially by The Endocrine Society's CGS and Clinical Affairs Core Committee, members responding to a web posting, and The Endocrine Society Council. At each stage, the Task Force incorporated changes in response to written comments. Conclusions: The Task Force recommends that the diagnosis of hypertriglyceridemia be based on fasting levels, that mild and moderate hypertriglyceridemia (triglycerides of 150–999 mg/dl) be diagnosed to aid in the evaluation of cardiovascular risk, and that severe and very severe hypertriglyceridemia (triglycerides of > 1000 mg/dl) be considered a risk for pancreatitis. The Task Force also recommends that patients with hypertriglyceridemia be evaluated for secondary causes of hyperlipidemia and that subjects with primary hypertriglyceridemia be evaluated for family history of dyslipidemia and cardiovascular disease. The Task Force recommends that the treatment goal in patients with moderate hypertriglyceridemia be a non-high-density lipoprotein cholesterol level in agreement with National Cholesterol Education Program Adult Treatment Panel guidelines. The initial treatment should be lifestyle therapy; a combination of diet modification and drug therapy may also be considered. In patients with severe or very severe hypertriglyceridemia, a fibrate should be used as a first-line agent. PMID:22962670

  11. Executive summary of the 2013 International Society for Clinical Densitometry Position Development Conference on bone densitometry.

    PubMed

    Schousboe, John T; Shepherd, John A; Bilezikian, John P; Baim, Sanford

    2013-01-01

    The International Society for Clinical Densitometry (ISCD) convenes a Position Development Conference (PDC) every 2-3 yr to make recommendations for guidelines and standards in the field of musculoskeletal measurement and assessment. The recommendations pertain to clinically relevant issues regarding the acquisition, quality control, interpretation, and reporting of various aspects of musculoskeletal health metrics. Topics for consideration are developed by the ISCD Board of Directors and the Scientific Advisory Committee. For the 2013 PDC, body composition analysis was a central topic area for the first time and considered timely because of the scientific advances in measurement of fat and lean body mass by dual-energy X-ray absorptiometry (DXA). Indications for DXA and vertebral fracture assessment and use of reference data to calculate bone mineral density T-scores were also updated. Task Forces for each of these areas were assigned questions of relevance to a clinical audience and asked to conduct comprehensive literature reviews. Reports with proposed Position Statements were then presented to an international panel of experts. The Expert Panel included representatives of the International Osteoporosis Foundation, the American Society for Bone and Mineral Research, the National Osteoporosis Foundation, Osteoporosis Canada, and the North American Menopause Society. The PDC was held in Tampa, FL, contemporaneously with the Annual Meeting of the ISCD, March 21 through March 23, 2013. This report describes the methodology of the 2013 ISCD PDC and summarizes the results of the 2013 ISCD PDC for vertebral fracture assessment/DXA and National Health and Nutrition Survey (NHANES) Reference Database Task Forces. A separate article in this issue will summarize the results of the Body Composition Analysis Task Forces. Copyright © 2013. Published by Elsevier Inc.

  12. Aspects of dosimetry and clinical practice of skin brachytherapy: The American Brachytherapy Society working group report.

    PubMed

    Ouhib, Zoubir; Kasper, Michael; Perez Calatayud, Jose; Rodriguez, Silvia; Bhatnagar, Ajay; Pai, Sujatha; Strasswimmer, John

    2015-01-01

    Nonmelanoma skin cancers (NMSCs) are the most common type of human malignancy. Although surgical techniques are the standard treatment, radiation therapy using photons, electrons, and brachytherapy (BT) (radionuclide-based and electronic) has been an important mode of treatment in specific clinical situations. The purpose of this work is to provide a clinical and dosimetric summary of the use of BT for the treatment of NMSC and to describe the different BT approaches used in treating cutaneous malignancies. A group of experts from the fields of radiation oncology, medical physics, and dermatology, who specialize in managing cutaneous malignancies reviewed the literature and compiled their clinical experience regarding the clinical and dosimetric aspects of skin BT. A dosimetric and clinical review of both high dose rate ((192)Ir) and electronic BT treatment including surface, interstitial, and custom mold applicators is given. Patient evaluation tools such as staging, imaging, and patient selection criteria are discussed. Guidelines for clinical and dosimetric planning, appropriate margin delineation, and applicator selection are suggested. Dose prescription and dose fractionation schedules, as well as prescription depth are discussed. Commissioning and quality assurance requirements are also outlined. Given the limited published data for skin BT, this article is a summary of the limited literature and best practices currently in use for the treatment of NMSC. Copyright © 2015 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.

  13. Advances in brain metastases presented at the American Society of Clinical Oncology 2016 Annual Meeting: Part I.

    PubMed

    Chen, Lucy F; Patel, Jyoti D; Lukas, Rimas V

    2016-11-01

    American Society of Clinical Oncology (ASCO) Annual Meeting, Chicago, IL, USA, 3-7 June 2016 The American Society of Clinical Oncology Annual Meeting took place in Chicago, IL, USA from 3 to 7 June 2016. Over 30,000 oncologists, researchers, related professionals and advocates participated in the conference which covered all aspects of oncology. An overview of the key studies in brain metastases presented at the 2016 American Society of Clinical Oncology Annual Meeting is highlighted here. This report highlights biology, epidemiology, prognosis and treatment sequelae of brain metastases.

  14. Advances in brain metastases presented at the American Society of Clinical Oncology 2016 Annual Meeting: Part II.

    PubMed

    Chen, Lucy F; Patel, Jyoti D; Lukas, Rimas V

    2016-12-01

    American Society of Clinical Oncology Annual Meeting, Chicago, IL, USA, 3-7 June 2016 The American Society of Clinical Oncology Annual Meeting took place in Chicago, IL, USA, from 3 to 7 June 2016. Over 30,000 oncologists, researchers, related professionals and advocates participated in the conference, which covered all aspects of oncology. An overview of the key studies in brain metastases presented at the 2016 American Society of Clinical Oncology Annual Meeting is highlighted here. Key data presented on radiotherapy, and systemic therapy for brain metastases are reviewed.

  15. The American Society of Clinical Oncology's Efforts to Support Global Cancer Medicine

    PubMed Central

    El-Saghir, Nagi S.; Cufer, Tanja; Cazap, Eduardo; de Guzman, Roselle; Othieno-Abinya, Nicholas Anthony; Sanchez, Jose Angel; Pyle, Doug

    2016-01-01

    Despite much progress in the management of malignant diseases, the number of new cases and cancer-related deaths continues to rise around the world. More than half of new cases occur in economically developing countries, where more than two thirds of cancer deaths are expected. However, implementation of all necessary steps to accomplish the dissemination of state-of-the-art prevention, diagnosis, and management will require increased allocation of resources, and, more importantly, harmonization of the efforts of hundreds of national and international public health agencies, policy-setting bodies, governments, pharmaceutical companies, and philanthropic organizations. More than 30% of the members of the American Society of Clinical Oncology (ASCO) reside and practice outside US borders, and more than half of attendees at all of the scientific congresses and symposia organized by ASCO are international. As cancer has become an increasingly global disease, ASCO has evolved as a global organization. The ASCO Board of Directors currently includes members from France, Brazil, and Canada. In 2013, the ASCO Board of Directors identified a number of strategic priorities for the future. Recognizing the importance of non-US members to the society, their first strategic priority was improving the society's service to non-US members and defining these members' identity in the international oncology community. This article reviews current ASCO activities in the international arena and its future plans in global oncology. PMID:26578614

  16. Recommendations for Obesity Clinical Trials in Cancer Survivors: American Society of Clinical Oncology Statement.

    PubMed

    Ligibel, Jennifer A; Alfano, Catherine M; Hershman, Dawn; Ballard, Rachel M; Bruinooge, Suanna S; Courneya, Kerry S; Daniels, Elvan C; Demark-Wahnefried, Wendy; Frank, Elizabeth S; Goodwin, Pamela J; Irwin, Melinda L; Levit, Laura A; McCaskill-Stevens, Worta; Minasian, Lori M; O'Rourke, Mark A; Pierce, John P; Stein, Kevin D; Thomson, Cynthia A; Hudis, Clifford A

    2015-11-20

    Observational evidence has established a relationship between obesity and cancer risk and outcomes. Interventional studies have demonstrated the feasibility and benefits of lifestyle change after cancer diagnosis, and guidelines recommend weight management and regular physical activity in cancer survivors; however, lifestyle interventions are not a routine part of cancer care. The ASCO Research Summit on Advancing Obesity Clinical Trials in Cancer Survivors sought to identify the knowledge gaps that clinical trials addressing energy balance factors in cancer survivors have not answered and to develop a roadmap for the design and implementation of studies with the potential to generate data that could lead to the evidence-based incorporation of weight management and physical activity programs into standard oncology practice. Recommendations highlight the need for large-scale trials evaluating the impact of energy balance interventions on cancer outcomes, as well as the concurrent conduct of studies focused on dissemination and implementation of interventions in diverse populations of cancer survivors, including answering critical questions about the degree of benefit in key subgroups of survivors. Other considerations include the importance of incorporating economic metrics into energy balance intervention trials, the need to establish intermediate biomarkers, and the importance of integrating traditional and nontraditional funding sources. Establishing lifestyle change after cancer diagnosis as a routine part of cancer care will require a multipronged effort to overcome barriers related to study development, funding, and stakeholder engagement. Given the prevalence of obesity and inactivity in cancer survivors in the United States and elsewhere, energy balance interventions hold the potential to reduce cancer morbidity and mortality in millions of patients, and it is essential that we move forward in determining their role in cancer care with the same care and

  17. The Clinical TMS Society Consensus Review and Treatment Recommendations for TMS Therapy for Major Depressive Disorder.

    PubMed

    Perera, Tarique; George, Mark S; Grammer, Geoffrey; Janicak, Philip G; Pascual-Leone, Alvaro; Wirecki, Theodore S

    2016-01-01

    Prefrontal Transcranial Magnetic Stimulation (TMS) therapy repeated daily over 4-6 weeks (20-30 sessions) is US Food and Drug Administration (FDA) approved for treating Major Depressive Disorder in adults who have not responded to prior antidepressant medications. In 2011, leading TMS clinical providers and researchers created the Clinical TMS Society (cTMSs) (www.clinicaltmssociety.org, Greenwich, CT, USA), incorporated in 2013. This consensus review was written by cTMSs leaders, informed by membership polls, and approved by the governing board. It summarizes current evidence for the safety and efficacy of the use of TMS therapy for treating depression in routine clinical practice. Authors systematically reviewed the published TMS antidepressant therapy clinical trials. Studies were then assessed and graded on their strength of evidence using the Levels of Evidence framework published by the University of Oxford Centre for Evidence Based Medicine. The authors then summarize essentials for using TMS therapy in routine clinical practice settings derived from discussions and polls of cTMSs members. Finally, each summary clinical recommendation is presented with the substantiating peer-reviewed, published evidence supporting that recommendation. When the current published clinical trial evidence was insufficient or incomplete, expert opinion was included when sufficient consensus was available from experienced clinician users among the membership of the cTMSs, who were polled at the Annual Meetings in 2014 and 2015. Daily left prefrontal TMS has substantial evidence of efficacy and safety for treating the acute phase of depression in patients who are treatment resistant or intolerant. Following the clinical recommendations in this document should result in continued safe and effective use of this exciting new treatment modality. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  18. Injection immunotherapy. British Society for Allergy and Clinical Immunology Working Party.

    PubMed Central

    Frew, A J

    1993-01-01

    A working party of the British Society for Allergy and Clinical Immunology has reviewed the role of specific allergen immunotherapy in the treatment of allergic disease and produced a position statement summarising the available evidence for efficacy and safety. The working party recommends specific allergen immunotherapy for treating summer hay fever uncontrolled by conventional medication and for wasp and bee venom hypersensitivity. It is not recommended for asthma or for allergic rhinitis due to other allergens. For the recommended indications the risk:benefit ratio is acceptable provided patients are carefully selected; in particular, patients with asthma should be excluded as they are especially vulnerable to adverse reactions. Injections should be given only by doctors experiences in this form of treatment in a clinic where full resuscitative facilities are immediately available. Provided patients remain symptom free a 60 minute observation period after injection is sufficient to detect all serious adverse reactions. PMID:8241857

  19. Do current clinical trials meet society's needs?: a critical review of recent evidence.

    PubMed

    Pocock, Stuart J; Gersh, Bernard J

    2014-10-14

    This paper describes some important controversies regarding the current state of clinical trials research in cardiology. Topics covered include the inadequacy of trial research on medical devices, problems with industry-sponsored trials, the lack of head-to-head trials of new effective treatments, the need for wiser handling of drug safety issues, the credibility (or lack thereof) of trial reports in medical journals, problems with globalization of trials, the role of personalized (stratified) medicine in trials, the need for new trials of old drugs, the need for trials of treatment withdrawal, the importance of pragmatic trials of treatment strategies, and the limitations of observational comparative effectiveness studies. All issues are illustrated by recent topical trials in cardiology. Overall, we explore the extent to which clinical trials, as currently practiced, are successful in meeting society's expectations.

  20. Diagnosis and management of hymenoptera venom allergy: British Society for Allergy and Clinical Immunology (BSACI) guidelines.

    PubMed

    Krishna, M T; Ewan, P W; Diwakar, L; Durham, S R; Frew, A J; Leech, S C; Nasser, S M

    2011-09-01

    This guidance for the management of patients with hymenoptera venom allergy has been prepared by the Standards of Care Committee (SOCC) of the British Society for Allergy and Clinical Immunology (BSACI). The guideline is based on evidence as well as on expert opinion and is for use by both adult physicians and pediatricians practising allergy. During the development of these guidelines, all BSACI members were included in the consultation process using a web-based system. Their comments and suggestions were carefully considered by the SOCC. Where evidence was lacking, consensus was reached by the experts on the committee. Included in this guideline are epidemiology, risk factors, clinical features, diagnostic tests, natural history of hymenoptera venom allergy and guidance on undertaking venom immunotherapy (VIT). There are also separate sections on children, elevated baseline tryptase and mastocytosis and mechanisms underlying VIT. Finally, we have made recommendations for potential areas of future research. © 2011 Blackwell Publishing Ltd.

  1. 2016 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards, Including Standards for Pediatric Oncology.

    PubMed

    Neuss, Michael N; Gilmore, Terry R; Belderson, Kristin M; Billett, Amy L; Conti-Kalchik, Tara; Harvey, Brittany E; Hendricks, Carolyn; LeFebvre, Kristine B; Mangu, Pamela B; McNiff, Kristen; Olsen, MiKaela; Schulmeister, Lisa; Von Gehr, Ann; Polovich, Martha

    2016-12-01

    Purpose To update the ASCO/Oncology Nursing Society (ONS) Chemotherapy Administration Safety Standards and to highlight standards for pediatric oncology. Methods The ASCO/ONS Chemotherapy Administration Safety Standards were first published in 2009 and updated in 2011 to include inpatient settings. A subsequent 2013 revision expanded the standards to include the safe administration and management of oral chemotherapy. A joint ASCO/ONS workshop with stakeholder participation, including that of the Association of Pediatric Hematology Oncology Nurses and American Society of Pediatric Hematology/Oncology, was held on May 12, 2015, to review the 2013 standards. An extensive literature search was subsequently conducted, and public comments on the revised draft standards were solicited. Results The updated 2016 standards presented here include clarification and expansion of existing standards to include pediatric oncology and to introduce new standards: most notably, two-person verification of chemotherapy preparation processes, administration of vinca alkaloids via minibags in facilities in which intrathecal medications are administered, and labeling of medications dispensed from the health care setting to be taken by the patient at home. The standards were reordered and renumbered to align with the sequential processes of chemotherapy prescription, preparation, and administration. Several standards were separated into their respective components for clarity and to facilitate measurement of adherence to a standard. Conclusion As oncology practice has changed, so have chemotherapy administration safety standards. Advances in technology, cancer treatment, and education and training have prompted the need for periodic review and revision of the standards. Additional information is available at http://www.asco.org/chemo-standards .

  2. The American Society for Clinical Pathology's 2014 vacancy survey of medical laboratories in the United States.

    PubMed

    Garcia, Edna; Ali, Asma M; Soles, Ryan M; Lewis, D Grace

    2015-09-01

    To determine the extent and distribution of workforce shortages within the nation's medical laboratories. Historically, the results of this biennial survey have served as a basis for additional research on laboratory recruitment, retention, education, marketing, certification, and advocacy. The 2014 Vacancy Survey was conducted through collaboration between American Society for Clinical Pathology's Institute of Science, Technology, and Policy in Washington, DC, and the Evaluation, Measurement, and Assessment Department and Board of Certification in Chicago, Illinois. Data were collected via an Internet survey that was distributed to individuals who were able to report on staffing and certifications for their laboratories. Data reveal increased overall vacancy rates since 2012 for all departments surveyed except cytology and cytogenetics. Also, results show higher anticipated retirement rates for both staff and supervisors. Overall certification rates are highest among laboratory personnel in cytogenetics, hematology/coagulation, and flow cytometry departments and lowest among phlebotomy, specimen processing, and anatomic pathology. Factors such as retirement and the improving economy are driving the need for more laboratory professionals. Recruitment of qualified laboratory professionals in the workforce and students in laboratory programs will be the key in fulfilling the higher vacancies revealed from the survey results in 2014. Copyright© by the American Society for Clinical Pathology.

  3. American Geriatrics Society abstracted clinical practice guideline for postoperative delirium in older adults.

    PubMed

    2015-01-01

    The abstracted set of recommendations presented here provides essential guidance both on the prevention of postoperative delirium in older patients at risk of delirium and on the treatment of older surgical patients with delirium, and is based on the 2014 American Geriatrics Society (AGS) Guideline. The full version of the guideline, American Geriatrics Society Clinical Practice Guideline for Postoperative Delirium in Older Adults is available at the website of the AGS. The overall aims of the study were twofold: first, to present nonpharmacologic and pharmacologic interventions that should be implemented perioperatively for the prevention of postoperative delirium in older adults; and second, to present nonpharmacologic and pharmacologic interventions that should be implemented perioperatively for the treatment of postoperative delirium in older adults. Prevention recommendations focused on primary prevention (i.e., preventing delirium before it occurs) in patients who are at risk for postoperative delirium (e.g., those identified as moderate-to-high risk based on previous risk stratification models such as the National Institute for Health and Care Excellence (NICE) guidelines, Delirium: Diagnosis, Prevention and Management. Clinical Guideline 103; London (UK): 2010 July 29). For management of delirium, the goals of this guideline are to decrease delirium severity and duration, ensure patient safety and improve outcomes.

  4. Role of American Society of Clinical Oncology in low- and middle-income countries.

    PubMed

    Patel, Jyoti D; Galsky, Matthew D; Chagpar, Anees B; Pyle, Doug; Loehrer, Patrick J

    2011-08-01

    The American Society of Clinical Oncology (ASCO) is a global community of health care professionals whose stated purpose is to "make a world of difference" by improving cancer care around the world. Unfortunately, cancer survival rates vary significantly among countries with differing financial and infrastructural resources. Because ASCO is a professional oncology society committed to conquering cancer through research, education, prevention, and delivery of high-quality patient care, it is ideally suited to address this issue. ASCO could bring together oncology professionals and other necessary stakeholders from around the world to improve cancer care and lessen suffering for patients worldwide. As part of the ongoing commitment of ASCO to the future of cancer care, the Leadership Development Program was created to foster the leadership skills of early and midcareer oncologists and provide these participants with a working knowledge of the depth and breadth of the organization. As participants in the inaugural class of the ASCO Leadership Development Program, we were charged with investigating how ASCO might favorably affect cancer prevention and treatment in resource-poor countries in a cost-effective, scalable, and sustainable fashion. ASCO can significantly influence cancer care in low- and middle-income countries through a comprehensive approach that promotes cancer awareness and education, improves clinical practice by identifying and removing barriers to delivery of quality cancer care, and fosters innovation to initiate novel solutions to complex problems.

  5. Management of Small Renal Masses: American Society of Clinical Oncology Clinical Practice Guideline.

    PubMed

    Finelli, Antonio; Ismaila, Nofisat; Bro, Bill; Durack, Jeremy; Eggener, Scott; Evans, Andrew; Gill, Inderbir; Graham, David; Huang, William; Jewett, Michael A S; Latcha, Sheron; Lowrance, William; Rosner, Mitchell; Shayegan, Bobby; Thompson, R Houston; Uzzo, Robert; Russo, Paul

    2017-02-20

    Purpose To provide recommendations for the management options for patients with small renal masses (SRMs). Methods By using a literature search and prospectively defined study selection, we sought systematic reviews, meta-analyses, randomized clinical trials, prospective comparative observational studies, and retrospective studies published from 2000 through 2015. Outcomes included recurrence-free survival, disease-specific survival, and overall survival. Results Eighty-three studies, including 20 systematic reviews and 63 primary studies, met the eligibility criteria and form the evidentiary basis for the guideline recommendations. Recommendations On the basis of tumor-specific findings and competing risks of mortality, all patients with an SRM should be considered for a biopsy when the results may alter management. Active surveillance should be an initial management option for patients who have significant comorbidities and limited life expectancy. Partial nephrectomy (PN) for SRMs is the standard treatment that should be offered to all patients for whom an intervention is indicated and who possess a tumor that is amenable to this approach. Percutaneous thermal ablation should be considered an option if complete ablation can reliably be achieved. Radical nephrectomy for SRMs should only be reserved for patients who possess a tumor of significant complexity that is not amenable to PN or for whom PN may result in unacceptable morbidity even when performed at centers with expertise. Referral to a nephrologist should be considered if chronic kidney disease (estimated glomerular filtration rate < 45 mL/min/1.73 m(2)) or progressive chronic kidney disease occurs after treatment, especially if associated with proteinuria.

  6. The 34th Annual Meeting of the German Society of Immunology with participation of the Polish Society of Experimental and Clinical Immunology.

    PubMed

    Wysocki, P J; Mackiewicz-Wysocka, M; Mackiewicz, A

    2004-02-01

    The 34th Annual Meeting of the German Society of Immunology was held in Berlin on 24 - 27 September 2003. This meeting, organised for the first time in cooperation with the Polish Society for Experimental and Clinical Immunology, gathered 1200 participants, mostly from central Europe. The programme comprised > 30 symposium lectures and > 750 oral and poster presentations. The main concept of this meeting was based on the rule of ABC--Applied, Basic and Clinical immunology. The state-of-the-art lectures devoted to immuno-based therapies provided by experts in the particular fields discussed some well-known therapeutic approaches. However, several workshop presentations demonstrated novel approaches employing biological therapies. These lectures are the focus of these meeting highlights.

  7. Ovarian cancer clinical trial endpoints: Society of Gynecologic Oncology white paper

    PubMed Central

    Herzog, Thomas J.; Armstrong, Deborah K.; Brady, Mark F.; Coleman, Robert L.; Einstein, Mark H.; Monk, Bradley J.; Mannel, Robert S.; Thigpen, J. Tate; Umpierre, Sharee A.; Villella, Jeannine A.; Alvarez, Ronald D.

    2015-01-01

    Objective To explore the value of multiple clinical endpoints in the unique setting of ovarian cancer. Methods A clinical trial workgroup was established by the Society of Gynecologic Oncology to develop a consensus statement via multiple conference calls, meetings and white paper drafts. Results Clinical trial endpoints have profound effects on late phase clinical trial design, result interpretation, drug development, and regulatory approval of therapeutics. Selection of the optimal clinical trial endpoint is particularly provocative in ovarian cancer where long overall survival (OS) is observed. The lack of new regulatory approvals and the lack of harmony between regulatory bodies globally for ovarian cancer therapeutics are of concern. The advantages and disadvantages of the numerous endpoints available are herein discussed within the unique context of ovarian cancer where both crossover and post-progression therapies potentially uncouple surrogacy between progression-free survival (PFS) and OS, the two most widely supported and utilized endpoints. The roles of patient reported outcomes (PRO) and health related quality of life (HRQoL) are discussed, but even these widely supported parameters are affected by the unique characteristics of ovarian cancer where a significant percentage of patients may be asymptomatic. Original data regarding the endpoint preferences of ovarian cancer advocates is presented. Conclusions Endpoint selection in ovarian cancer clinical trials should reflect the impact on disease burden and unique characteristics of the treatment cohort while reflecting true patient benefit. Both OS and PFS have led to regulatory approvals and are clinically important. OS remains the most objective and accepted endpoint because it is least vulnerable to bias; however, the feasibility of OS in ovarian cancer is compromised by the requirement for large trial size, prolonged time-line for final analysis, and potential for unintended loss of treatment effect

  8. Charting the Future of Cancer Health Disparities Research: A Position Statement from the American Association of Cancer Research, the American Cancer Society, the American Society of Clinical Oncology, and the National Cancer Institute

    Cancer.gov

    The American Association for Cancer Research, American Cancer Society, American Society of Clinical Oncology, and NCI present a unified strategy to promote cooperation in all areas of the cancer health disparities research community.

  9. Improving the Evidence Base for Treating Older Adults With Cancer: American Society of Clinical Oncology Statement.

    PubMed

    Hurria, Arti; Levit, Laura A; Dale, William; Mohile, Supriya G; Muss, Hyman B; Fehrenbacher, Louis; Magnuson, Allison; Lichtman, Stuart M; Bruinooge, Suanna S; Soto-Perez-de-Celis, Enrique; Tew, William P; Postow, Michael A; Cohen, Harvey J

    2015-11-10

    The American Society of Clinical Oncology (ASCO) convened a subcommittee to develop recommendations on improving the evidence base for treating older adults with cancer in response to a critical need identified by the Institute of Medicine. Older adults experience the majority of cancer diagnoses and deaths and make up the majority of cancer survivors. Older adults are also the fastest growing segment of the US population. However, the evidence base for treating this population is sparse, because older adults are underrepresented in clinical trials, and trials designed specifically for older adults are rare. The result is that clinicians have less evidence on how to treat older adults, who represent the majority of patients with cancer. Clinicians and patients are forced to extrapolate from trials conducted in younger, healthier populations when developing treatment plans. This has created a dearth of knowledge regarding the risk of toxicity in the average older patient and about key end points of importance to older adults. ASCO makes five recommendations to improve evidence generation in this population: (1) Use clinical trials to improve the evidence base for treating older adults with cancer, (2) leverage research designs and infrastructure for generating evidence on older adults with cancer, (3) increase US Food and Drug Administration authority to incentivize and require research involving older adults with cancer, (4) increase clinicians' recruitment of older adults with cancer to clinical trials, and (5) use journal policies to improve researchers' reporting on the age distribution and health risk profiles of research participants.

  10. [Report of the 10th Annual Meeting of the Chinese society of Clinical Oncology].

    PubMed

    Cho, William Chi-Shing

    2008-03-01

    The 10th Annual Meeting of the Chinese Society of Clinical Oncology (CSCO) was held on 19-23 September 2007 in Harbin. The theme of this conference was "putting standard multidisciplinary cancer management into practice" and special reports of standard multidisciplinary management on various cancers were presented. Over 3 500 clinical oncologists and scientists participated in the 2007 CSCO Annual Meeting where more than ten international top experts were invited to exchange valuable experiences with the delegates. The programs consisted of Education Session, Satellite Symposium and Meet the Professor Session. The latest research results were presented as oral presentations and posters at the congress. Several hotspots were particularly highlighted in this report, including innovative radiotherapy and chemotherapy methods, researches on molecular targets and clinical trials of targeted therapy, such as endostatin, volociximab, cetuximab, bevacizumab and temozolomide. The remarkable research results of anti-cancer Chinese medicine, cancer screening and prognosis were also introduced. This article tries to call the attention to some hot topics in the program that are both new and noteworthy, and it may serve as a highlight of this important international cancer research meeting for clinical oncologists and scientists.

  11. American Society of Clinical Oncology Technology Assessment: chemotherapy sensitivity and resistance assays.

    PubMed

    Schrag, Deborah; Garewal, Harinder S; Burstein, Harold J; Samson, David J; Von Hoff, Daniel D; Somerfield, Mark R

    2004-09-01

    To develop a technology assessment of chemotherapy sensitivity and resistance assays in order to define the role of these tests in routine oncology practice. The American Society of Clinical Oncology (ASCO) established a Working Group to develop the technology assessment. The Working Group collaborated with the Blue Cross and Blue Shield Association (BCBSA) Technology Evaluation Center. The Working Group developed independent criteria for selecting articles for inclusion in the ASCO assessment, and developed a structured data abstraction tool to facilitate review of selected manuscripts. One Working Group member and an ASCO staff member independently reviewed the 1,139 abstracts identified by the BCBSA comprehensive literature search, and by an updated literature search performed by ASCO using the BCBSA search strategy (1966 to January 2004). Of the 12 articles included in this technology assessment, eight were identified by the original BCBSA systematic review, one was provided by industry, and three were identified by the ASCO updated literature review. Review of the literature does not identify any CSRAs for which the evidence base is sufficient to support use in oncology practice. The use of chemotherapy sensitivity and resistance assays to select chemotherapeutic agents for individual patients is not recommended outside of the clinical trial setting. Oncologists should make chemotherapy treatment recommendations on the basis of published reports of clinical trials and a patient's health status and treatment preferences. Because the in vitro analytic strategy has potential importance, participation in clinical trials evaluating these technologies remains a priority.

  12. Evaluation and treatment of adult growth hormone deficiency: an Endocrine Society Clinical Practice Guideline.

    PubMed

    Molitch, Mark E; Clemmons, David R; Malozowski, Saul; Merriam, George R; Shalet, Stephen M; Vance, Mary Lee; Stephens, Patricia A

    2006-05-01

    The objective is to provide guidelines for the evaluation and treatment of adults with GH deficiency (GHD). The chair of the Task Force was selected by the Clinical Guidelines Subcommittee of The Endocrine Society (TES). The chair selected five other endocrinologists and a medical writer, who were approved by the Council. One closed meeting of the group was held. There was no corporate funding, and members of the group received no remuneration. Only fully published, peer-reviewed literature was reviewed. The Grades of Evidence used are outlined in the Appendix. Consensus was achieved through one group meeting and e-mailing of drafts that were written by the group with grammatical/style help from the medical writer. Drafts were reviewed successively by the Clinical Guidelines Subcommittee, the Clinical Affairs Committee, and TES Council, and a version was placed on the TES web site for comments. At each level, the writing group incorporated needed changes. GHD can persist from childhood or be newly acquired. Confirmation through stimulation testing is usually required unless there is a proven genetic/structural lesion persistent from childhood. GH therapy offers benefits in body composition, exercise capacity, skeletal integrity, and quality of life measures and is most likely to benefit those patients who have more severe GHD. The risks of GH treatment are low. GH dosing regimens should be individualized. The final decision to treat adults with GHD requires thoughtful clinical judgment with a careful evaluation of the benefits and risks specific to the individual.

  13. An Official American Thoracic Society Clinical Practice Guideline: Pediatric Chronic Home Invasive Ventilation.

    PubMed

    Sterni, Laura M; Collaco, Joseph M; Baker, Christopher D; Carroll, John L; Sharma, Girish D; Brozek, Jan L; Finder, Jonathan D; Ackerman, Veda L; Arens, Raanan; Boroughs, Deborah S; Carter, Jodi; Daigle, Karen L; Dougherty, Joan; Gozal, David; Kevill, Katharine; Kravitz, Richard M; Kriseman, Tony; MacLusky, Ian; Rivera-Spoljaric, Katherine; Tori, Alvaro J; Ferkol, Thomas; Halbower, Ann C

    2016-04-15

    Children with chronic invasive ventilator dependence living at home are a diverse group of children with special health care needs. Medical oversight, equipment management, and community resources vary widely. There are no clinical practice guidelines available to health care professionals for the safe hospital discharge and home management of these complex children. To develop evidence-based clinical practice guidelines for the hospital discharge and home/community management of children requiring chronic invasive ventilation. The Pediatric Assembly of the American Thoracic Society assembled an interdisciplinary workgroup with expertise in the care of children requiring chronic invasive ventilation. The experts developed four questions of clinical importance and used an evidence-based strategy to identify relevant medical evidence. Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology was used to formulate and grade recommendations. Clinical practice recommendations for the management of children with chronic ventilator dependence at home are provided, and the evidence supporting each recommendation is discussed. Collaborative generalist and subspecialist comanagement is the Medical Home model most likely to be successful for the care of children requiring chronic invasive ventilation. Standardized hospital discharge criteria are suggested. An awake, trained caregiver should be present at all times, and at least two family caregivers should be trained specifically for the child's care. Standardized equipment for monitoring, emergency preparedness, and airway clearance are outlined. The recommendations presented are based on the current evidence and expert opinion and will require an update as new evidence and/or technologies become available.

  14. An Official American Thoracic Society Workshop Report: Developing Performance Measures from Clinical Practice Guidelines

    PubMed Central

    Gould, Michael K.; Krishnan, Jerry A.; Wilson, Kevin C.; Au, David H.; Cooke, Colin R.; Douglas, Ivor S.; Feemster, Laura C.; Mularski, Richard A.; Slatore, Christopher G.; Renda Soylemez, Wiener

    2014-01-01

    Many health care performance measures are either not based on high-quality clinical evidence or not tightly linked to patient-centered outcomes, limiting their usefulness in quality improvement. In this report we summarize the proceedings of an American Thoracic Society workshop convened to address this problem by reviewing current approaches to performance measure development and creating a framework for developing high-quality performance measures by basing them directly on recommendations from well-constructed clinical practice guidelines. Workshop participants concluded that ideally performance measures addressing care processes should be linked to clinical practice guidelines that explicitly rate the quality of evidence and the strength of recommendations, such as the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process. Under this framework, process-based performance measures would only be developed from strong recommendations based on high- or moderate-quality evidence. This approach would help ensure that clinical processes specified in performance measures are both of clear benefit to patients and supported by strong evidence. Although this approach may result in fewer performance measures, it would substantially increase the likelihood that quality-improvement programs based on these measures actually improve patient care. PMID:24828810

  15. An official American thoracic society workshop report: developing performance measures from clinical practice guidelines.

    PubMed

    Kahn, Jeremy M; Gould, Michael K; Krishnan, Jerry A; Wilson, Kevin C; Au, David H; Cooke, Colin R; Douglas, Ivor S; Feemster, Laura C; Mularski, Richard A; Slatore, Christopher G; Wiener, Renda Soylemez

    2014-05-01

    Many health care performance measures are either not based on high-quality clinical evidence or not tightly linked to patient-centered outcomes, limiting their usefulness in quality improvement. In this report we summarize the proceedings of an American Thoracic Society workshop convened to address this problem by reviewing current approaches to performance measure development and creating a framework for developing high-quality performance measures by basing them directly on recommendations from well-constructed clinical practice guidelines. Workshop participants concluded that ideally performance measures addressing care processes should be linked to clinical practice guidelines that explicitly rate the quality of evidence and the strength of recommendations, such as the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process. Under this framework, process-based performance measures would only be developed from strong recommendations based on high- or moderate-quality evidence. This approach would help ensure that clinical processes specified in performance measures are both of clear benefit to patients and supported by strong evidence. Although this approach may result in fewer performance measures, it would substantially increase the likelihood that quality-improvement programs based on these measures actually improve patient care.

  16. Clinical Cancer Advances 2013: Annual Report on Progress Against Cancer from the American Society of Clinical Oncology.

    PubMed

    Patel, Jyoti D; Krilov, Lada; Adams, Sylvia; Aghajanian, Carol; Basch, Ethan; Brose, Marcia S; Carroll, William L; de Lima, Marcos; Gilbert, Mark R; Kris, Mark G; Marshall, John L; Masters, Gregory A; O'Day, Steven J; Polite, Blasé; Schwartz, Gary K; Sharma, Sunil; Thompson, Ian; Vogelzang, Nicholas J; Roth, Bruce J

    2014-01-10

    Since its founding in 1964, the American Society of Clinical Oncology (ASCO) has been committed to improving cancer outcomes through research and the delivery of quality care. Research is the bedrock of discovering better treatments--providing hope to the millions of individuals who face a cancer diagnosis each year. The studies featured in "Clinical Cancer Advances 2013: Annual Report on Progress Against Cancer From the American Society of Clinical Oncology" represent the invaluable contributions of thousands of patients who participate in clinical trials and the scientists who conduct basic and clinical research. The insights described in this report, such as how cancers hide from the immune system and why cancers may become resistant to targeted drugs, enable us to envision a future in which cancer will be even more controllable and preventable. The scientific process is thoughtful, deliberate, and sometimes slow, but each advance, while helping patients, now also points toward new research questions and unexplored opportunities. Both dramatic and subtle breakthroughs occur so that progress against cancer typically builds over many years. Success requires vision, persistence, and a long-term commitment to supporting cancer research and training. Our nation's longstanding investment in federally funded cancer research has contributed significantly to a growing array of effective new treatments and a much deeper understanding of the drivers of cancer. But despite this progress, our position as a world leader in advancing medical knowledge and our ability to attract the most promising and talented investigators are now threatened by an acute problem: Federal funding for cancer research has steadily eroded over the past decade, and only 15% of the ever-shrinking budget is actually spent on clinical trials. This dismal reality threatens the pace of progress against cancer and undermines our ability to address the continuing needs of our patients. Despite this

  17. An official American Thoracic Society/Society of Thoracic Radiology clinical practice guideline: evaluation of suspected pulmonary embolism in pregnancy.

    PubMed

    Leung, Ann N; Bull, Todd M; Jaeschke, Roman; Lockwood, Charles J; Boiselle, Phillip M; Hurwitz, Lynne M; James, Andra H; McCullough, Laurence B; Menda, Yusuf; Paidas, Michael J; Royal, Henry D; Tapson, Victor F; Winer-Muram, Helen T; Chervenak, Frank A; Cody, Dianna D; McNitt-Gray, Michael F; Stave, Christopher D; Tuttle, Brandi D

    2011-11-15

    Pulmonary embolism (PE) is a leading cause of maternal mortality in the developed world. Along with appropriate prophylaxis and therapy, prevention of death from PE in pregnancy requires a high index of clinical suspicion followed by a timely and accurate diagnostic approach. To provide guidance on this important health issue, a multidisciplinary panel of major medical stakeholders was convened to develop evidence-based guidelines for evaluation of suspected pulmonary embolism in pregnancy using the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) system. In formulation of the recommended diagnostic algorithm, the important outcomes were defined to be diagnostic accuracy and diagnostic yield; the panel placed a high value on minimizing cumulative radiation dose when determining the recommended sequence of tests. Overall, the quality of the underlying evidence for all recommendations was rated as very low or low, with some of the evidence considered for recommendations extrapolated from studies of the general population. Despite the low-quality evidence, strong recommendations were made for three specific scenarios: performance of chest radiography (CXR) as the first radiation-associated procedure; use of lung scintigraphy as the preferred test in the setting of a normal CXR; and performance of computed-tomographic pulmonary angiography (CTPA) rather than digital subtraction angiography (DSA) in a pregnant woman with a nondiagnostic ventilation-perfusion (V/Q) result. The recommendations presented in this guideline are based upon the currently available evidence; availability of new clinical research data and development and dissemination of new technologies will necessitate a revision and update.

  18. Tracking the workforce: the American Society of Clinical Oncology workforce information system.

    PubMed

    Kirkwood, M Kelsey; Kosty, Michael P; Bajorin, Dean F; Bruinooge, Suanna S; Goldstein, Michael A

    2013-01-01

    In anticipation of oncologist workforce shortages projected as part of a 2007 study, the American Society of Clinical Oncology (ASCO) worked with a contractor to create a workforce information system (WIS) to assemble the latest available data on oncologist supply and cancer incidence and prevalence. ASCO plans to publish findings annually, reporting on new data and tracking trends over time. THE WIS REPORT IS COMPOSED OF THREE SECTIONS: supply, new entrants, and cancer incidence and prevalence. Tabulations of the number of oncologists in the United States are derived mainly from the American Medical Association Physician Masterfile. Information on fellows and residents in the oncology workforce pipeline come from published sources such as Journal of the American Medical Association. Incidence and prevalence estimates are published by the American Cancer Society and National Cancer Institute. The WIS reports a total of 13,084 oncologists working in the United States in 2011. Oncologists are defined as those physicians who designate hematology, hematology/oncology, or medical oncology as their specialty. The WIS compares the characteristics of these oncologists with those of all physicians and tracks emerging trends in the physician training pipeline. Observing characteristics of the oncologist workforce over time allows ASCO to identify, prioritize, and evaluate its workforce initiatives. Accessible figures and reports generated by the WIS can be used by ASCO and others in the oncology community to advocate for needed health care system and policy changes to help offset future workforce shortages.

  19. Tracking the Workforce: The American Society of Clinical Oncology Workforce Information System

    PubMed Central

    Kirkwood, M. Kelsey; Kosty, Michael P.; Bajorin, Dean F.; Bruinooge, Suanna S.; Goldstein, Michael A.

    2013-01-01

    Purpose: In anticipation of oncologist workforce shortages projected as part of a 2007 study, the American Society of Clinical Oncology (ASCO) worked with a contractor to create a workforce information system (WIS) to assemble the latest available data on oncologist supply and cancer incidence and prevalence. ASCO plans to publish findings annually, reporting on new data and tracking trends over time. Methods: The WIS report is composed of three sections: supply, new entrants, and cancer incidence and prevalence. Tabulations of the number of oncologists in the United States are derived mainly from the American Medical Association Physician Masterfile. Information on fellows and residents in the oncology workforce pipeline come from published sources such as Journal of the American Medical Association. Incidence and prevalence estimates are published by the American Cancer Society and National Cancer Institute. Results: The WIS reports a total of 13,084 oncologists working in the United States in 2011. Oncologists are defined as those physicians who designate hematology, hematology/oncology, or medical oncology as their specialty. The WIS compares the characteristics of these oncologists with those of all physicians and tracks emerging trends in the physician training pipeline. Conclusion: Observing characteristics of the oncologist workforce over time allows ASCO to identify, prioritize, and evaluate its workforce initiatives. Accessible figures and reports generated by the WIS can be used by ASCO and others in the oncology community to advocate for needed health care system and policy changes to help offset future workforce shortages. PMID:23633965

  20. 2017 Infectious Diseases Society of America's Clinical Practice Guidelines for Healthcare-Associated Ventriculitis and Meningitis.

    PubMed

    Tunkel, Allan R; Hasbun, Rodrigo; Bhimraj, Adarsh; Byers, Karin; Kaplan, Sheldon L; Michael Scheld, W; van de Beek, Diederik; Bleck, Thomas P; Garton, Hugh J L; Zunt, Joseph R

    2017-02-14

    The Infectious Diseases Society of America (IDSA) Standards and Practice Guidelines Committee collaborated with partner organizations to convene a panel of 10 experts on healthcare-associated ventriculitis and meningitis. The panel represented pediatric and adult specialists in the field of infectious diseases and represented other organizations whose members care for patients with healthcare-associated ventriculitis and meningitis (American Academy of Neurology, American Association of Neurological Surgeons, and Neurocritical Care Society). The panel reviewed articles based on literature reviews, review articles and book chapters, evaluated the evidence and drafted recommendations. Questions were reviewed and approved by panel members. Subcategories were included for some questions based on specific populations of patients who may develop healthcare-associated ventriculitis and meningitis after the following procedures or situations: cerebrospinal fluid shunts, cerebrospinal fluid drains, implantation of intrathecal infusion pumps, implantation of deep brain stimulation hardware, and general neurosurgery and head trauma. Recommendations were followed by the strength of the recommendation and the quality of the evidence supporting the recommendation. Many recommendations, however, were based on expert opinion because rigorous clinical data are not available. These guidelines represent a practical and useful approach to assist practicing clinicians in the management of these challenging infections.

  1. Biliary stenting: indications, choice of stents and results: European Society of Gastrointestinal Endoscopy (ESGE) clinical guideline.

    PubMed

    Dumonceau, J-M; Tringali, A; Blero, D; Devière, J; Laugiers, R; Heresbach, D; Costamagna, G

    2012-03-01

    This article is part of a combined publication that expresses the current view of the European Society of Gastrointestinal Endoscopy about endoscopic biliary stenting. The present Clinical Guideline describes short-term and long-term results of biliary stenting depending on indications and stent models; it makes recommendations on when, how, and with which stent to perform biliary drainage in most common clinical settings, including in patients with a potentially resectable malignant biliary obstruction and in those who require palliative drainage of common bile duct or hilar strictures. Treatment of benign conditions (strictures related to chronic pancreatitis, liver transplantation, or cholecystectomy, and leaks and failed biliary stone extraction) and management of complications (including stent revision) are also discussed. A two-page executive summary of evidence statements and recommendations is provided. A separate Technology Review describes the models of biliary stents available and the stenting techniques, including advanced techniques such as insertion of multiple plastic stents, drainage of hilar strictures, retrieval of migrated stents and combined stenting in malignant biliary and duodenal obstructions.The target readership for the Clinical Guideline mostly includes digestive endoscopists, gastroenterologists, oncologists, radiologists, internists, and surgeons while the Technology Review should be most useful to endoscopists who perform biliary drainage.

  2. Official American Thoracic Society Clinical Practice Guidelines: Diagnostic Evaluation of Infants with Recurrent or Persistent Wheezing.

    PubMed

    Ren, Clement L; Esther, Charles R; Debley, Jason S; Sockrider, Marianna; Yilmaz, Ozge; Amin, Nikhil; Bazzy-Asaad, Alia; Davis, Stephanie D; Durand, Manuel; Ewig, Jeffrey M; Yuksel, Hasan; Lombardi, Enrico; Noah, Terry L; Radford, Peggy; Ranganathan, Sarath; Teper, Alejandro; Weinberger, Miles; Brozek, Jan; Wilson, Kevin C

    2016-08-01

    Infantile wheezing is a common problem, but there are no guidelines for the evaluation of infants with recurrent or persistent wheezing that is not relieved or prevented by standard therapies. An American Thoracic Society-sanctioned guideline development committee selected clinical questions related to uncertainties or controversies in the diagnostic evaluation of wheezing infants. Members of the committee conducted pragmatic evidence syntheses, which followed the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach. The evidence syntheses were used to inform the formulation and grading of recommendations. The pragmatic evidence syntheses identified few studies that addressed the clinical questions. The studies that were identified constituted very low-quality evidence, consisting almost exclusively of case series with risk of selection bias, indirect patient populations, and imprecise estimates. The committee made conditional recommendations to perform bronchoscopic airway survey, bronchoalveolar lavage, esophageal pH monitoring, and a swallowing study. It also made conditional recommendations against empiric food avoidance, upper gastrointestinal radiography, and gastrointestinal scintigraphy. Finally, the committee recommended additional research about the roles of infant pulmonary function testing and food avoidance or dietary changes, based on allergy testing. Although infantile wheezing is common, there is a paucity of evidence to guide clinicians in selecting diagnostic tests for recurrent or persistent wheezing. Our committee made several conditional recommendations to guide clinicians; however, additional research that measures clinical outcomes is needed to improve our confidence in the effects of various diagnostic interventions and to allow advice to be provided with greater confidence.

  3. The Official Positions of the International Society for Clinical Densitometry: body composition analysis reporting.

    PubMed

    Petak, Steven; Barbu, Carmen G; Yu, Elaine W; Fielding, Roger; Mulligan, Kathleen; Sabowitz, Brian; Wu, Chih-Hsing; Shepherd, John A

    2013-01-01

    Dual-energy x-ray absorptiometry (DXA) measurements of body composition increasingly are used in the evaluation of clinical disorders, but there has been little guidance on how to effectively report these measures. Uniformity in reporting of body composition measures will aid in the diagnosis of clinical disorders such as obesity, sarcopenia, and lipodystrophy. At the 2013 International Society for Clinical Densitometry Position Development Conference on body composition, the reporting section recommended that all DXA body composition reports should contain parameters of body mass index, bone mineral density, BMC, total mass, total lean mass, total fat mass, and percent fat mass. The inclusion of additional measures of adiposity and lean mass are optional, including visceral adipose tissue, appendicular lean mass index, android/gynoid percent fat ratio, trunk to leg fat mass ratio, lean mass index, and fat mass index. Within the United States, we recommend the use of the National Health and Nutrition Examination Survey 1999-2004 body composition dataset as an age-, gender-, and race-specific reference and to calibrate BMC in 4-compartment models. Z-scores and percentiles of body composition measures may be useful for clinical interpretation if methods are used to adjust for non-normality. In particular, DXA body composition measures may be useful for risk-stratification of obese and sarcopenic patients, but there needs to be validation of thresholds to define obesity and sarcopenia. To summarize, these guidelines provide evidence-based standards for the reporting and clinical application of DXA-based measures of body composition.

  4. American Society of Clinical Oncology policy for relationships with companies: background and rationale.

    PubMed

    2013-06-01

    The American Society of Clinical Oncology's (ASCO's) new conflict of interest policy reflects a commitment to transparency and independence in the development and presentation of scientific and educational content. ASCO supports thorough and accessible disclosure of financial relationships with companies at institutional and individual levels and calls for rigorous evaluation of content in light of the information disclosed. For abstracts and articles presenting original research, ASCO holds first, last, and corresponding authors to a clear standard of independence. In imposing restrictions, the new policy focuses on the role of these authors rather than of the principal investigator(s) as in the previous policy. ASCO remains actively engaged with the broader scientific community in seeking and implementing efficient, effective approaches to conflict of interest management.

  5. The American Society for Clinical Pathology's 2015 Wage Survey of Medical Laboratories in the United States.

    PubMed

    Garcia, Edna; Fisher, Patrick B

    2017-04-01

    To inform the pathology and laboratory field of the most recent national wage data from the American Society for Clinical Pathology (ASCP). Historically, the results of this biennial survey have served as a basis for additional research on laboratory recruitment, retention, education, marketing, certification, and advocacy. The 2015 wage survey was conducted through collaboration between the ASCP's Institute of Science, Technology, & Policy in Washington, DC, and the ASCP Board of Certification in Chicago, Illinois. Electronic survey invitations were sent to individuals who are currently practicing in the field. Data reveal increased salaries since 2013 for all staff-level laboratory professionals surveyed except phlebotomists and pathologists' assistants. Laboratory assistants and phlebotomists, regardless of level, continue to have lower salaries while pathologists' assistants and administration personnel have higher salaries than the rest of the laboratory professions surveyed. Survey results put emphasis on strategic recruitment and retention by laboratory training programs and institutions that hire laboratory professionals.

  6. The American Society for Clinical Pathology's 2015 Wage Survey of Medical Laboratories in the United States.

    PubMed

    Garcia, Edna; Fisher, Patrick B

    2017-05-01

    To inform the pathology and laboratory field of the most recent national wage data from the American Society for Clinical Pathology (ASCP). Historically, the results of this biennial survey have served as a basis for additional research on laboratory recruitment, retention, education, marketing, certification, and advocacy. The 2015 wage survey was conducted through collaboration between the ASCP's Institute of Science, Technology, and Policy in Washington, DC, and the ASCP Board of Certification in Chicago, Illinois. Electronic survey invitations were sent to individuals who are currently practicing in the field. Data reveal increased salaries since 2013 for all staff-level laboratory professionals surveyed except phlebotomists and pathologists' assistants. Laboratory assistants and phlebotomists, regardless of level, continue to have lower salaries while pathologists' assistants and administration personnel have higher salaries than the rest of the laboratory professions surveyed. Survey results put emphasis on strategic recruitment and retention by laboratory training programs and institutions that hire laboratory professionals.

  7. Clinical cancer advances 2011: Annual Report on Progress Against Cancer from the American Society of Clinical Oncology.

    PubMed

    Vogelzang, Nicholas J; Benowitz, Steven I; Adams, Sylvia; Aghajanian, Carol; Chang, Susan Marina; Dreyer, Zoann Eckert; Janne, Pasi A; Ko, Andrew H; Masters, Greg A; Odenike, Olatoyosi; Patel, Jyoti D; Roth, Bruce J; Samlowski, Wolfram E; Seidman, Andrew D; Tap, William D; Temel, Jennifer S; Von Roenn, Jamie H; Kris, Mark G

    2012-01-01

    A message from ASCO'S President. It has been forty years since President Richard Nixon signed the National Cancer Act of 1971, which many view as the nation's declaration of the "War on Cancer." The bill has led to major investments in cancer research and significant increases in cancer survival. Today, two-thirds of patients survive at least five years after being diagnosed with cancer compared with just half of all diagnosed patients surviving five years after diagnosis in 1975. The research advances detailed in this year's Clinical Cancer Advances demonstrate that improvements in cancer screening, treatment, and prevention save and improve lives. But although much progress has been made, cancer remains one of the world's most serious health problems. In the United States, the disease is expected to become the nation's leading cause of death in the years ahead as our population ages. I believe we can accelerate the pace of progress, provided that everyone involved in cancer care works together to achieve this goal. It is this viewpoint that has shaped the theme for my presidential term: Collaborating to Conquer Cancer. In practice, this means that physicians and researchers must learn from every patient's experience, ensure greater collaboration between members of a patient's medical team, and involve more patients in the search for cures through clinical trials. Cancer advocates, insurers, and government agencies also have important roles to play. Today, we have an incredible opportunity to improve the quality of cancer care by drawing lessons from the real-world experiences of patients. The American Society of Clinical Oncology (ASCO) is taking the lead in this area, in part through innovative use of health information technology. In addition to our existing quality initiatives, ASCO is working with partners to develop a comprehensive rapid-learning system for cancer care. When complete, this system will provide physicians with personalized, real

  8. American Society of Clinical Oncology position statement on obesity and cancer.

    PubMed

    Ligibel, Jennifer A; Alfano, Catherine M; Courneya, Kerry S; Demark-Wahnefried, Wendy; Burger, Robert A; Chlebowski, Rowan T; Fabian, Carol J; Gucalp, Ayca; Hershman, Dawn L; Hudson, Melissa M; Jones, Lee W; Kakarala, Madhuri; Ness, Kirsten K; Merrill, Janette K; Wollins, Dana S; Hudis, Clifford A

    2014-11-01

    Rates of obesity have increased significantly over the last three decades in the United States and globally. In addition to contributing to heart disease and diabetes, obesity is a major unrecognized risk factor for cancer. Obesity is associated with worsened prognosis after cancer diagnosis and also negatively affects the delivery of systemic therapy, contributes to morbidity of cancer treatment, and may raise the risk of second malignancies and comorbidities. Research shows that the time after a cancer diagnosis can serve as a teachable moment to motivate individuals to adopt risk-reducing behaviors. For this reason, the oncology care team--the providers with whom a patient has the closest relationships in the critical period after a cancer diagnosis--is in a unique position to help patients lose weight and make other healthy lifestyle changes. The American Society of Clinical Oncology is committed to reducing the impact of obesity on cancer and has established a multipronged initiative to accomplish this goal by 1) increasing education and awareness of the evidence linking obesity and cancer; 2) providing tools and resources to help oncology providers address obesity with their patients; 3) building and fostering a robust research agenda to better understand the pathophysiology of energy balance alterations, evaluate the impact of behavior change on cancer outcomes, and determine the best methods to help cancer survivors make effective and useful changes in lifestyle behaviors; and 4) advocating for policy and systems change to address societal factors contributing to obesity and improve access to weight management services for patients with cancer. © 2014 by American Society of Clinical Oncology.

  9. Official American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children.

    PubMed

    Lewinsohn, David M; Leonard, Michael K; LoBue, Philip A; Cohn, David L; Daley, Charles L; Desmond, Ed; Keane, Joseph; Lewinsohn, Deborah A; Loeffler, Ann M; Mazurek, Gerald H; O'Brien, Richard J; Pai, Madhukar; Richeldi, Luca; Salfinger, Max; Shinnick, Thomas M; Sterling, Timothy R; Warshauer, David M; Woods, Gail L

    2017-01-15

    Individuals infected with Mycobacterium tuberculosis (Mtb) may develop symptoms and signs of disease (tuberculosis disease) or may have no clinical evidence of disease (latent tuberculosis infection [LTBI]). Tuberculosis disease is a leading cause of infectious disease morbidity and mortality worldwide, yet many questions related to its diagnosis remain. A task force supported by the American Thoracic Society, Centers for Disease Control and Prevention, and Infectious Diseases Society of America searched, selected, and synthesized relevant evidence. The evidence was then used as the basis for recommendations about the diagnosis of tuberculosis disease and LTBI in adults and children. The recommendations were formulated, written, and graded using the Grading, Recommendations, Assessment, Development and Evaluation (GRADE) approach. Twenty-three evidence-based recommendations about diagnostic testing for latent tuberculosis infection, pulmonary tuberculosis, and extrapulmonary tuberculosis are provided. Six of the recommendations are strong, whereas the remaining 17 are conditional. These guidelines are not intended to impose a standard of care. They provide the basis for rational decisions in the diagnosis of tuberculosis in the context of the existing evidence. No guidelines can take into account all of the often compelling unique individual clinical circumstances. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

  10. Official American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children.

    PubMed

    Lewinsohn, David M; Leonard, Michael K; LoBue, Philip A; Cohn, David L; Daley, Charles L; Desmond, Ed; Keane, Joseph; Lewinsohn, Deborah A; Loeffler, Ann M; Mazurek, Gerald H; O'Brien, Richard J; Pai, Madhukar; Richeldi, Luca; Salfinger, Max; Shinnick, Thomas M; Sterling, Timothy R; Warshauer, David M; Woods, Gail L

    2017-01-15

    Individuals infected with Mycobacterium tuberculosis (Mtb) may develop symptoms and signs of disease (tuberculosis disease) or may have no clinical evidence of disease (latent tuberculosis infection [LTBI]). Tuberculosis disease is a leading cause of infectious disease morbidity and mortality worldwide, yet many questions related to its diagnosis remain. A task force supported by the American Thoracic Society, Centers for Disease Control and Prevention, and Infectious Diseases Society of America searched, selected, and synthesized relevant evidence. The evidence was then used as the basis for recommendations about the diagnosis of tuberculosis disease and LTBI in adults and children. The recommendations were formulated, written, and graded using the Grading, Recommendations, Assessment, Development and Evaluation (GRADE) approach. Twenty-three evidence-based recommendations about diagnostic testing for latent tuberculosis infection, pulmonary tuberculosis, and extrapulmonary tuberculosis are provided. Six of the recommendations are strong, whereas the remaining 17 are conditional. These guidelines are not intended to impose a standard of care. They provide the basis for rational decisions in the diagnosis of tuberculosis in the context of the existing evidence. No guidelines can take into account all of the often compelling unique individual clinical circumstances. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

  11. American Thoracic Society documents: an official American Thoracic Society/Society of Thoracic Radiology Clinical Practice Guideline--Evaluation of Suspected Pulmonary Embolism in Pregnancy.

    PubMed

    Leung, Ann N; Bull, Todd M; Jaeschke, Roman; Lockwood, Charles J; Boiselle, Phillip M; Hurwitz, Lynne M; James, Andra H; McCullough, Laurence B; Menda, Yusuf; Paidas, Michael J; Royal, Henry D; Tapson, Victor F; Winer-Muram, Helen T; Chervenak, Frank A; Cody, Dianna D; McNitt-Gray, Michael F; Stave, Christopher D; Tuttle, Brandi D

    2012-02-01

    Pulmonary embolism (PE) is a leading cause of maternal mortality in the developed world. Along with appropriate prophylaxis and therapy, prevention of death from PE in pregnancy requires a high index of clinical suspicion followed by a timely and accurate diagnostic approach. To provide guidance on this important health issue, a multidisciplinary panel of major medical stakeholders was convened to develop evidence-based guidelines for evaluation of suspected pulmonary embolism in pregnancy using the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) system. In formulation of the recommended diagnostic algorithm, the important outcomes were defined to be diagnostic accuracy and diagnostic yield; the panel placed a high value on minimizing cumulative radiation dose when determining the recommended sequence of tests. Overall, the quality of the underlying evidence for all recommendations was rated as very low or low with some of the evidence considered for recommendations extrapolated from studies of the general population. Despite the low quality evidence, strong recommendations were made for three specific scenarios: performance of chest radiography (CXR) as the first radiation-associated procedure; use of lung scintigraphy as the preferred test in the setting of a normal CXR; and performance of computed-tomographic pulmonary angiography (CTPA) rather than digital subtraction angiography (DSA) in a pregnant woman with a nondiagnostic ventilation-perfusion (V/Q) result. The recommendations presented in this guideline are based upon the currently available evidence; availability of new clinical research data and development and dissemination of new technologies will necessitate a revision and update. © RSNA, 2011

  12. The geography of clinical cancer research: analysis of abstracts presented at the American Society of Clinical Oncology Annual Meetings.

    PubMed

    Saad, E D; Mangabeira, A; Masson, A L; Prisco, F E

    2010-03-01

    The American Society of Clinical Oncology Annual Meeting is the largest forum for presentation of clinical research in oncology. We quantified the contribution of countries and assessed correlates of their presence at such meetings. After stratifying abstracts according to category of presentation (oral, poster, and 'publication only'), we took a random sample of 10% of the studies presented at years 2001-2003 and 2006-2008. We assigned abstract nationality using the affiliation of authors. For multinational studies, we developed an algorithm to assign nationality. Of the 22 045 eligible abstracts, 2206 were analyzed and represented 71 countries: 905 (41%) abstracts were from a single institution, 969 (44%) were multicenter, uninational studies, and 332 (15%) were multinational studies. United States nationality was assigned to 49% of all abstracts and the next 14 countries with a higher number of studies accounted for 41%. There was a statistically significant temporal trend in the proportion of multinational studies. Also, multinational studies and abstracts with United States nationality were more frequently presented in oral and poster fashion and had more frequent involvement of the pharmaceutical industry. This study provides a geographic overview of clinical cancer research and indicates that multinational collaboration is increasing.

  13. Screening for prostate cancer with prostate-specific antigen testing: American Society of Clinical Oncology Provisional Clinical Opinion.

    PubMed

    Basch, Ethan; Oliver, Thomas K; Vickers, Andrew; Thompson, Ian; Kantoff, Philip; Parnes, Howard; Loblaw, D Andrew; Roth, Bruce; Williams, James; Nam, Robert K

    2012-08-20

    An American Society of Clinical Oncology (ASCO) provisional clinical opinion (PCO) offers timely clinical direction to the ASCO membership after publication or presentation of potentially practice-changing data from major studies. This PCO addresses the role of prostate-specific antigen (PSA) testing in the screening of men for prostate cancer. Prostate cancer is the second leading cause of cancer deaths among men in the United States. The rationale for screening men for prostate cancer is the potential to reduce the risk of death through early detection. Evidence from a 2011 Agency for Healthcare Research and Quality systematic review primarily informs this PCO on the benefits and harms of PSA-based screening. An update search was conducted to March 16, 2012, for additional evidence related to the topic. In one randomized trial, PSA testing in men who would not otherwise have been screened resulted in reduced death rates from prostate cancer, but it is uncertain whether the size of the effect was worth the harms associated with screening and subsequent unnecessary treatment. Although there are limitations to the existing data, there is evidence to suggest that men with longer life expectancy may benefit from PSA testing. Adverse events associated with prostate biopsy are low for the majority of men; however, several population-based studies have shown increasing rates of infectious complications after prostate biopsy, which is a concern.

  14. Integration of Palliative Care Into Standard Oncology Care: American Society of Clinical Oncology Clinical Practice Guideline Update.

    PubMed

    Ferrell, Betty R; Temel, Jennifer S; Temin, Sarah; Alesi, Erin R; Balboni, Tracy A; Basch, Ethan M; Firn, Janice I; Paice, Judith A; Peppercorn, Jeffrey M; Phillips, Tanyanika; Stovall, Ellen L; Zimmermann, Camilla; Smith, Thomas J

    2017-01-01

    Purpose To provide evidence-based recommendations to oncology clinicians, patients, family and friend caregivers, and palliative care specialists to update the 2012 American Society of Clinical Oncology (ASCO) provisional clinical opinion (PCO) on the integration of palliative care into standard oncology care for all patients diagnosed with cancer. Methods ASCO convened an Expert Panel of members of the ASCO Ad Hoc Palliative Care Expert Panel to develop an update. The 2012 PCO was based on a review of a randomized controlled trial (RCT) by the National Cancer Institute Physicians Data Query and additional trials. The panel conducted an updated systematic review seeking randomized clinical trials, systematic reviews, and meta-analyses, as well as secondary analyses of RCTs in the 2012 PCO, published from March 2010 to January 2016. Results The guideline update reflects changes in evidence since the previous guideline. Nine RCTs, one quasiexperimental trial, and five secondary analyses from RCTs in the 2012 PCO on providing palliative care services to patients with cancer and/or their caregivers, including family caregivers, were found to inform the update. Recommendations Inpatients and outpatients with advanced cancer should receive dedicated palliative care services, early in the disease course, concurrent with active treatment. Referral of patients to interdisciplinary palliative care teams is optimal, and services may complement existing programs. Providers may refer family and friend caregivers of patients with early or advanced cancer to palliative care services.

  15. Pediatric Obesity-Assessment, Treatment, and Prevention: An Endocrine Society Clinical Practice Guideline.

    PubMed

    Styne, Dennis M; Arslanian, Silva A; Connor, Ellen L; Farooqi, Ismaa Sadaf; Murad, M Hassan; Silverstein, Janet H; Yanovski, Jack A

    2017-03-01

    The European Society of Endocrinology and the Pediatric Endocrine Society. This guideline was funded by the Endocrine Society. To formulate clinical practice guidelines for the assessment, treatment, and prevention of pediatric obesity. The participants include an Endocrine Society-appointed Task Force of 6 experts, a methodologist, and a medical writer. 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 2 systematic reviews and used the best available evidence from other published systematic reviews and individual studies. One group meeting, several conference calls, and e-mail communications enabled consensus. Endocrine Society committees and members and co-sponsoring organizations reviewed and commented on preliminary drafts of this guideline. Pediatric obesity remains an ongoing serious international health concern affecting ∼17% of US children and adolescents, threatening their adult health and longevity. Pediatric obesity has its basis in genetic susceptibilities influenced by a permissive environment starting in utero and extending through childhood and adolescence. Endocrine etiologies for obesity are rare and usually are accompanied by attenuated growth patterns. Pediatric comorbidities are common and long-term health complications often result; screening for comorbidities of obesity should be applied in a hierarchal, logical manner for early identification before more serious complications result. Genetic screening for rare syndromes is indicated only in the presence of specific historical or physical features. The psychological toll of pediatric obesity on the individual and family necessitates screening for mental health issues and counseling as indicated. The prevention of pediatric obesity by promoting healthful diet, activity, and environment should be a primary goal, as

  16. American Society of Clinical Oncology technology assessment on breast cancer risk reduction strategies: tamoxifen and raloxifene.

    PubMed

    Chlebowski, R T; Collyar, D E; Somerfield, M R; Pfister, D G

    1999-06-01

    To conduct an evidence-based technology assessment to determine whether tamoxifen and raloxifene as breast cancer risk-reduction strategies are appropriate for broad-based conventional use in clinical practice. Tamoxifen and raloxifene. Outcomes of interest include breast cancer incidence, breast cancer-specific survival, overall survival, and net health benefits. A comprehensive, formal literature review was conducted for tamoxifen and raloxifene on the following topics: breast cancer risk reduction; tamoxifen side effects and toxicity, including endometrial cancer risk; tamoxifen influences on nonmalignant diseases, including coronary heart disease and osteoporosis; and decision making by women at risk for breast cancer. Testimony was collected from invited experts and interested parties. More weight was given to publications that described randomized trials. BENEFITS/HARMS/COSTS: The American Society of Clinical Oncology (ASCO) Working Group acknowledges that a woman's decision regarding breast cancer risk-reduction strategies will depend on the importance and weight attributed to the information provided regarding both cancer and non-cancer-related risks. For women with a defined 5-year projected risk of breast cancer of >/= 1.66%, tamoxifen (at 20 mg/d for up to 5 years) may be offered to reduce their risk. It is premature to recommend raloxifene use to lower the risk of developing breast cancer outside of a clinical trial setting. On the basis of available information, use of raloxifene should currently be reserved for its approved indication to prevent bone loss in postmenopausal women. Conclusions are based on single-agent use of the drugs. At the present time, the effect of using tamoxifen or raloxifene with other medications (such as hormone replacement therapy), or using tamoxifen and raloxifene in combination or sequentially, has not been studied adequately. The continuing use of placebo-controlled trials in other risk-reduction trials highlights the

  17. Molecular Biomarkers for the Evaluation of Colorectal Cancer: Guideline From the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology.

    PubMed

    Sepulveda, Antonia R; Hamilton, Stanley R; Allegra, Carmen J; Grody, Wayne; Cushman-Vokoun, Allison M; Funkhouser, William K; Kopetz, Scott E; Lieu, Christopher; Lindor, Noralane M; Minsky, Bruce D; Monzon, Federico A; Sargent, Daniel J; Singh, Veena M; Willis, Joseph; Clark, Jennifer; Colasacco, Carol; Rumble, R Bryan; Temple-Smolkin, Robyn; Ventura, Christina B; Nowak, Jan A

    2017-03-01

    To develop evidence-based guideline recommendations through a systematic review of the literature to establish standard molecular biomarker testing of colorectal cancer (CRC) tissues to guide epidermal growth factor receptor (EGFR) therapies and conventional chemotherapy regimens. The American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology convened an expert panel to develop an evidence-based guideline to establish standard molecular biomarker testing and guide therapies for patients with CRC. A comprehensive literature search that included more than 4,000 articles was conducted. Twenty-one guideline statements were established. Evidence supports mutational testing for EGFR signaling pathway genes, since they provide clinically actionable information as negative predictors of benefit to anti-EGFR monoclonal antibody therapies for targeted therapy of CRC. Mutations in several of the biomarkers have clear prognostic value. Laboratory approaches to operationalize CRC molecular testing are presented. Key Words: Molecular diagnostics; Gastrointestinal; Histology; Genetics; Oncology. Copyright © 2017 American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, American Society for Clinical Oncology, and American Society for Investigative Pathology. Published by Elsevier Inc. All rights reserved.

  18. An Official American Thoracic Society Clinical Practice Guideline: Pediatric Chronic Home Invasive Ventilation

    PubMed Central

    Collaco, Joseph M.; Baker, Christopher D.; Carroll, John L.; Sharma, Girish D.; Brozek, Jan L.; Finder, Jonathan D.; Ackerman, Veda L.; Arens, Raanan; Boroughs, Deborah S.; Carter, Jodi; Daigle, Karen L.; Dougherty, Joan; Gozal, David; Kevill, Katharine; Kravitz, Richard M.; Kriseman, Tony; MacLusky, Ian; Rivera-Spoljaric, Katherine; Tori, Alvaro J.; Ferkol, Thomas; Halbower, Ann C.

    2016-01-01

    Background: Children with chronic invasive ventilator dependence living at home are a diverse group of children with special health care needs. Medical oversight, equipment management, and community resources vary widely. There are no clinical practice guidelines available to health care professionals for the safe hospital discharge and home management of these complex children. Purpose: To develop evidence-based clinical practice guidelines for the hospital discharge and home/community management of children requiring chronic invasive ventilation. Methods: The Pediatric Assembly of the American Thoracic Society assembled an interdisciplinary workgroup with expertise in the care of children requiring chronic invasive ventilation. The experts developed four questions of clinical importance and used an evidence-based strategy to identify relevant medical evidence. Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology was used to formulate and grade recommendations. Results: Clinical practice recommendations for the management of children with chronic ventilator dependence at home are provided, and the evidence supporting each recommendation is discussed. Conclusions: Collaborative generalist and subspecialist comanagement is the Medical Home model most likely to be successful for the care of children requiring chronic invasive ventilation. Standardized hospital discharge criteria are suggested. An awake, trained caregiver should be present at all times, and at least two family caregivers should be trained specifically for the child’s care. Standardized equipment for monitoring, emergency preparedness, and airway clearance are outlined. The recommendations presented are based on the current evidence and expert opinion and will require an update as new evidence and/or technologies become available. PMID:27082538

  19. American Society of Clinical Oncology provisional clinical opinion: the integration of palliative care into standard oncology care.

    PubMed

    Smith, Thomas J; Temin, Sarah; Alesi, Erin R; Abernethy, Amy P; Balboni, Tracy A; Basch, Ethan M; Ferrell, Betty R; Loscalzo, Matt; Meier, Diane E; Paice, Judith A; Peppercorn, Jeffrey M; Somerfield, Mark; Stovall, Ellen; Von Roenn, Jamie H

    2012-03-10

    An American Society of Clinical Oncology (ASCO) provisional clinical opinion (PCO) offers timely clinical direction to ASCO's membership following publication or presentation of potentially practice-changing data from major studies. This PCO addresses the integration of palliative care services into standard oncology practice at the time a person is diagnosed with metastatic or advanced cancer. Palliative care is frequently misconstrued as synonymous with end-of-life care. Palliative care is focused on the relief of suffering, in all of its dimensions, throughout the course of a patient's illness. Although the use of hospice and other palliative care services at the end of life has increased, many patients are enrolled in hospice less than 3 weeks before their death, which limits the benefit they may gain from these services. By potentially improving quality of life (QOL), cost of care, and even survival in patients with metastatic cancer, palliative care has increasing relevance for the care of patients with cancer. Until recently, data from randomized controlled trials (RCTs) demonstrating the benefits of palliative care in patients with metastatic cancer who are also receiving standard oncology care have not been available. Seven published RCTs form the basis of this PCO. Based on strong evidence from a phase III RCT, patients with metastatic non-small-cell lung cancer should be offered concurrent palliative care and standard oncologic care at initial diagnosis. While a survival benefit from early involvement of palliative care has not yet been demonstrated in other oncology settings, substantial evidence demonstrates that palliative care-when combined with standard cancer care or as the main focus of care-leads to better patient and caregiver outcomes. These include improvement in symptoms, QOL, and patient satisfaction, with reduced caregiver burden. Earlier involvement of palliative care also leads to more appropriate referral to and use of hospice, and

  20. Colorectal cancer surveillance: 2005 update of an American Society of Clinical Oncology practice guideline.

    PubMed

    Desch, Christopher E; Benson, Al B; Somerfield, Mark R; Flynn, Patrick J; Krause, Carol; Loprinzi, Charles L; Minsky, Bruce D; Pfister, David G; Virgo, Katherine S; Petrelli, Nicholas J

    2005-11-20

    To update the 2000 American Society of Clinical Oncology guideline on colorectal cancer surveillance. Based on results from three independently reported meta-analyses of randomized controlled trials that compared low-intensity and high-intensity programs of colorectal cancer surveillance, and on recent analyses of data from major clinical trials in colon and rectal cancer, the Panel recommends annual computed tomography (CT) of the chest and abdomen for 3 years after primary therapy for patients who are at higher risk of recurrence and who could be candidates for curative-intent surgery; pelvic CT scan for rectal cancer surveillance, especially for patients with several poor prognostic factors, including those who have not been treated with radiation; colonoscopy at 3 years after operative treatment, and, if results are normal, every 5 years thereafter; flexible proctosigmoidoscopy [corrected] every 6 months for 5 years for rectal cancer patients who have not been treated with pelvic radiation; history and physical examination every 3 to 6 months for the first 3 years, every 6 months during years 4 and 5, and subsequently at the discretion of the physician; and carcinoembryonic antigen every 3 months postoperatively for at least 3 years after diagnosis, if the patient is a candidate for surgery or systemic therapy. Chest x-rays, CBCs, and liver function tests are not recommended, and molecular or cellular markers should not influence the surveillance strategy based on available evidence.

  1. Advancing Clinical Practice and Policy through Guidelines. The Role of the American Thoracic Society

    PubMed Central

    Gould, Michael K.

    2013-01-01

    In the face of an overwhelmingly large and growing medical literature, providers often turn to clinical practice guidelines to inform the decisions they make with patients. By systematically appraising the evidence and providing transparent recommendations for practice, guidelines have the potential to improve both bedside decision-making and health policy. This potential has not been fully realized because most guidelines lack transparency, are tainted by conflicts of interest, or fail to employ rigorous methods to appraise the evidence. To address the shortcomings of past guidelines, the Institute of Medicine (IOM) published recommendations for trustworthy guidelines, effectively setting the “gold standard” for what constitutes a high-quality guideline. Along with many other groups that develop guidelines, the American Thoracic Society (ATS) is rapidly evolving processes for development and implementation to meet many of the IOM standards. This Pulmonary Perspective describes the rapidly changing landscape of clinical practice guidelines, the role of the ATS in this landscape, and the activities the ATS is engaged in to ensure that the guidelines it produces are of the highest quality with the broadest impact. PMID:23392437

  2. Multiple Myeloma: Clinical Updates From the American Society of Hematology Annual Meeting 2016.

    PubMed

    Terpos, Evangelos

    2017-06-01

    The novel clinical data for plasma cell neoplasms (smoldering myeloma, multiple myeloma (MM) and AL-amyloidosis) that were presented in the 2016 Annual Meeting of the American Society of Hematology are summarized here. Data from large phase 3 studies for newly diagnosed MM patients who are eligible for autologous transplantation (EMN02, MRC XI and StaMINA trials) are described along with the results of phase 2 studies using novel anti-myeloma drug combinations for induction, consolidation and maintenance as first line therapy. Recent updates of previous important studies in the field of both newly diagnosed (FIRST) and relapsed/refractory MM (POLLUX, CASTOR) are also reported. Moreover, the results of clinical studies with the use of anti-myeloma drugs with new mechanisms of action, including pembrolizumab, selinexor, venetoclax and monoclonal antibodies, are discussed. All these data provide the basis for possible changes in the way we manage myeloma in the near future trying to "cure" the disease. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. The impact of HIV infection on society's perception of clinical trials.

    PubMed

    Levine, R J

    1994-06-01

    All international codes of research ethics and virtually all national legislation and regulation in the field of research involving human subjects project an attitude of protectionism. Written with the aim of avoiding a repetition of atrocities like those committed by the Nazi physician-researchers, calamities like the thalidomide experience, or ethical violations like those of the Tuskegee syphilis study, their dominant concerns are the protection of individuals from injury and from exploitation. In recent years, however, society's perception of clinical research has shifted dramatically. Now, largely as a consequence of the efforts of the AIDS activists, clinical research is widely perceived as benign and beneficial. Although this shift in attitude has resulted in some important improvements in research policies and practices, this new perception is just as wrong-headed as was the earlier excessive protectionism. It is necessary to maintain a balanced perspective; our policies should encourage the conduct of ethical research while maintaining the vigilance necessary to safeguard the rights and welfare of the subjects.

  4. [Second Clinical Consensus of the Ibero-American Society of Neonatology: hemodynamic management of newborns].

    PubMed

    Golombek, Sergio G; Fariña, Diana; Sola, Augusto; Baquero, Hernando; Cabañas, Fernando; Dominguez, Fernando; Fajardo, Carlos; Goldsmit, Gustavo S; Flores, Gabriel Lara; Lee, Mario; Varela, Lourdes Lemus; Mariani, Gonzalo; Miura, Ernani; Pérez, Jose Maria; Zambosco, Guillermo; Pellicer, Adelina; Bancalari, Eduardo

    2011-04-01

    This study reports on the process and results of the Second Clinical Consensus of the Ibero-American Society of Neonatology. Eighty neonatologists from 23 countries were invited to collaborate and participate in the event. Several questions of clinical-physiological importance in the hemodynamic management of newborns were addressed. Participants were divided into groups to facilitate interaction and teamwork, with instructions to respond to three to five questions by analyzing the literature and local factors. Meeting in Mar del Plata, Argentina, the Consensus Group served as a form for various presentations and discussions. In all, 54 neonatologists from 21 countries attended, with the objective of reaching a consensus on such matters as concepts and definitions of hemodynamic instability, the physiopathology of hemodynamic compromise, recommended therapy strategies, and hemodynamic monitoring. It is hoped that this international experience will serve as a useful initiative for future consensus building and reduction of the existing disparities among the countries of the Region in terms of treatment and outcomes.

  5. [Past roles and future prospects of the National Clinical Database for board-certifying systems of the Japan Surgical Society].

    PubMed

    Kitago, Minoru; Kitagawa, Yuko

    2014-01-01

    Board-certifying systems play an important role as guideposts in postgraduate training courses to develop superior surgeons with both general and subspecialty surgery competence. The board-certified surgeon designation of the Japan Surgical Society (JSS) as the first guidepost has provided the foundations for board-certified surgeon systems of subspecialty surgical societies as the second guidepost. In April 2010, the National Clinical Database (NCD) was founded by the JSS and other societies. Data on surgery and treatment have been entered into the NCD from January 1, 2011, and more than 1 million cases were submitted to the NCD in that year. The NCD is an unprecedented, advanced activity. The data will be used for the authorization of board-certified surgeons of subspecialty surgical societies as well as that of the JSS. The data will be also used for benchmarking, and clinical research teams will cooperate with the NCD.

  6. An official American Thoracic Society clinical practice guideline: the clinical utility of bronchoalveolar lavage cellular analysis in interstitial lung disease.

    PubMed

    Meyer, Keith C; Raghu, Ganesh; Baughman, Robert P; Brown, Kevin K; Costabel, Ulrich; du Bois, Roland M; Drent, Marjolein; Haslam, Patricia L; Kim, Dong Soon; Nagai, Sonoko; Rottoli, Paola; Saltini, Cesare; Selman, Moisés; Strange, Charlie; Wood, Brent

    2012-05-01

    The clinical utility of bronchoalveolar lavage fluid (BAL) cell analysis for the diagnosis and management of patients with interstitial lung disease (ILD) has been a subject of debate and controversy. The American Thoracic Society (ATS) sponsored a committee of international experts to examine all relevant literature on BAL in ILD and provide recommendations concerning the use of BAL in the diagnosis and management of patients with suspected ILD. To provide recommendations for (1) the performance and processing of BAL and (2) the interpretation of BAL nucleated immune cell patterns and other BAL characteristics in patients with suspected ILD. A pragmatic systematic review was performed to identify unique citations related to BAL in patients with ILD that were published between 1970 and 2006. The search was updated during the guideline development process to include published literature through March 2011. This is the evidence upon which the committee's conclusions and recommendations are based. Recommendations for the performance and processing of BAL, as well as the interpretation of BAL findings, were formulated by the committee. When used in conjunction with comprehensive clinical information and adequate thoracic imaging such as high-resolution computed tomography of the thorax, BAL cell patterns and other characteristics frequently provide useful information for the diagnostic evaluation of patients with suspected ILD.

  7. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice.

    PubMed

    Reddel, Helen K; Taylor, D Robin; Bateman, Eric D; Boulet, Louis-Philippe; Boushey, Homer A; Busse, William W; Casale, Thomas B; Chanez, Pascal; Enright, Paul L; Gibson, Peter G; de Jongste, Johan C; Kerstjens, Huib A M; Lazarus, Stephen C; Levy, Mark L; O'Byrne, Paul M; Partridge, Martyn R; Pavord, Ian D; Sears, Malcolm R; Sterk, Peter J; Stoloff, Stuart W; Sullivan, Sean D; Szefler, Stanley J; Thomas, Mike D; Wenzel, Sally E

    2009-07-01

    The assessment of asthma control is pivotal to the evaluation of treatment response in individuals and in clinical trials. Previously, asthma control, severity, and exacerbations were defined and assessed in many different ways. The Task Force was established to provide recommendations about standardization of outcomes relating to asthma control, severity, and exacerbations in clinical trials and clinical practice, for adults and children aged 6 years or older. A narrative literature review was conducted to evaluate the measurement properties and strengths/weaknesses of outcome measures relevant to asthma control and exacerbations. The review focused on diary variables, physiologic measurements, composite scores, biomarkers, quality of life questionnaires, and indirect measures. The Task Force developed new definitions for asthma control, severity, and exacerbations, based on current treatment principles and clinical and research relevance. In view of current knowledge about the multiple domains of asthma and asthma control, no single outcome measure can adequately assess asthma control. Its assessment in clinical trials and in clinical practice should include components relevant to both of the goals of asthma treatment, namely achievement of best possible clinical control and reduction of future risk of adverse outcomes. Recommendations are provided for the assessment of asthma control in clinical trials and clinical practice, both at baseline and in the assessment of treatment response. The Task Force recommendations provide a basis for a multicomponent assessment of asthma by clinicians, researchers, and other relevant groups in the design, conduct, and evaluation of clinical trials, and in clinical practice.

  8. Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update

    PubMed Central

    Masters, Gregory A.; Temin, Sarah; Azzoli, Christopher G.; Giaccone, Giuseppe; Baker, Sherman; Brahmer, Julie R.; Ellis, Peter M.; Gajra, Ajeet; Rackear, Nancy; Schiller, Joan H.; Smith, Thomas J.; Strawn, John R.; Trent, David; Johnson, David H.

    2015-01-01

    Purpose To provide evidence-based recommendations to update the American Society of Clinical Oncology guideline on systemic therapy for stage IV non–small-cell lung cancer (NSCLC). Methods An Update Committee of the American Society of Clinical Oncology NSCLC Expert Panel based recommendations on a systematic review of randomized controlled trials from January 2007 to February 2014. Results This guideline update reflects changes in evidence since the previous guideline. Recommendations There is no cure for patients with stage IV NSCLC. For patients with performance status (PS) 0 to 1 (and appropriate patient cases with PS 2) and without an EGFR-sensitizing mutation or ALK gene rearrangement, combination cytotoxic chemotherapy is recommended, guided by histology, with early concurrent palliative care. Recommendations for patients in the first-line setting include platinum-doublet therapy for those with PS 0 to 1 (bevacizumab may be added to carboplatin plus paclitaxel if no contraindications); combination or single-agent chemotherapy or palliative care alone for those with PS 2; afatinib, erlotinib, or gefitinib for those with sensitizing EGFR mutations; crizotinib for those with ALK or ROS1 gene rearrangement; and following first-line recommendations or using platinum plus etoposide for those with large-cell neuroendocrine carcinoma. Maintenance therapy includes pemetrexed continuation for patients with stable disease or response to first-line pemetrexed-containing regimens, alternative chemotherapy, or a chemotherapy break. In the second-line setting, recommendations include docetaxel, erlotinib, gefitinib, or pemetrexed for patients with nonsquamous cell carcinoma; docetaxel, erlotinib, or gefitinib for those with squamous cell carcinoma; and chemotherapy or ceritinib for those with ALK rearrangement who experience progression after crizotinib. In the third-line setting, for patients who have not received erlotinib or gefitinib, treatment with erlotinib is

  9. Esophageal stenting for benign and malignant disease: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline.

    PubMed

    Spaander, Manon C W; Baron, Todd H; Siersema, Peter D; Fuccio, Lorenzo; Schumacher, Brigitte; Escorsell, Àngels; Garcia-Pagán, Juan-Carlos; Dumonceau, Jean-Marc; Conio, Massimo; de Ceglie, Antonella; Skowronek, Janusz; Nordsmark, Marianne; Seufferlein, Thomas; Van Gossum, André; Hassan, Cesare; Repici, Alessandro; Bruno, Marco J

    2016-10-01

    This Guideline is an official statement of the European Society of Gastrointestinal Endoscopy (ESGE), endorsed by the European Society for Radiotherapy and Oncology (ESTRO), the European Society of Digestive Endoscopy (ESDO), and the European Society for Clinical Nutrition and Metabolism (ESPEN). The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system was adopted to define the strength of recommendations and the quality of evidence. Main recommendations for malignant disease 1 ESGE recommends placement of partially or fully covered self-expandable metal stents (SEMSs) for palliative treatment of malignant dysphagia over laser therapy, photodynamic therapy, and esophageal bypass (strong recommendation, high quality evidence). 2 For patients with longer life expectancy, ESGE recommends brachytherapy as a valid alternative or in addition to stenting in esophageal cancer patients with malignant dysphagia. Brachytherapy may provide a survival advantage and possibly a better quality of life compared to SEMS placement alone. (Strong recommendation, high quality evidence.) 3 ESGE recommends esophageal SEMS placement as the preferred treatment for sealing malignant tracheoesophageal or bronchoesophageal fistula (strong recommendation, low quality evidence). 4 ESGE does not recommend the use of concurrent external radiotherapy and esophageal stent treatment. SEMS placement is also not recommended as a bridge to surgery or prior to preoperative chemoradiotherapy. It is associated with a high incidence of adverse events and alternative satisfactory options such as placement of a feeding tube are available. (Strong recommendation, low quality evidence.) Main recommendations for benign disease 1 ESGE recommends against the use of self-expandable stents (SEMSs) as first-line therapy for the management of benign esophageal strictures because of the potential for adverse events, the availability of alternative therapies, and costs (strong

  10. Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons: An Endocrine Society* Clinical Practice Guideline.

    PubMed

    Hembree, Wylie C; Cohen-Kettenis, Peggy T; Gooren, Louis; Hannema, Sabine E; Meyer, Walter J; Murad, M Hassan; Rosenthal, Stephen M; Safer, Joshua D; Tangpricha, Vin; T'Sjoen, Guy G

    2017-09-13

    To update the "Endocrine Treatment of Transsexual Persons: An Endocrine Society Clinical Practice Guideline," published by the Endocrine Society in 2009. The participants include an Endocrine Society-appointed task force of nine experts, a methodologist, and a medical writer. 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. 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. 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

  11. Clinical guidelines on central venous catheterisation. Swedish Society of Anaesthesiology and Intensive Care Medicine.

    PubMed

    Frykholm, P; Pikwer, A; Hammarskjöld, F; Larsson, A T; Lindgren, S; Lindwall, R; Taxbro, K; Oberg, F; Acosta, S; Akeson, J

    2014-05-01

    Safe and reliable venous access is mandatory in modern health care, but central venous catheters (CVCs) are associated with significant morbidity and mortality, This paper describes current Swedish guidelines for clinical management of CVCs The guidelines supply updated recommendations that may be useful in other countries as well. Literature retrieval in the Cochrane and Pubmed databases, of papers written in English or Swedish and pertaining to CVC management, was done by members of a task force of the Swedish Society of Anaesthesiology and Intensive Care Medicine. Consensus meetings were held throughout the review process to allow all parts of the guidelines to be embraced by all contributors. All of the content was carefully scored according to criteria by the Oxford Centre for Evidence-Based Medicine. We aimed at producing useful and reliable guidelines on bleeding diathesis, vascular approach, ultrasonic guidance, catheter tip positioning, prevention and management of associated trauma and infection, and specific training and follow-up. A structured patient history focused on bleeding should be taken prior to insertion of a CVCs. The right internal jugular vein should primarily be chosen for insertion of a wide-bore CVC. Catheter tip positioning in the right atrium or lower third of the superior caval vein should be verified for long-term use. Ultrasonic guidance should be used for catheterisation by the internal jugular or femoral veins and may also be used for insertion via the subclavian veins or the veins of the upper limb. The operator inserting a CVC should wear cap, mask, and sterile gown and gloves. For long-term intravenous access, tunnelled CVC or subcutaneous venous ports are preferred. Intravenous position of the catheter tip should be verified by clinical or radiological methods after insertion and before each use. Simulator-assisted training of CVC insertion should precede bedside training in patients. Units inserting and managing CVC should

  12. American Society of Clinical Oncology 1998 update of recommended breast cancer surveillance guidelines.

    PubMed

    Smith, T J; Davidson, N E; Schapira, D V; Grunfeld, E; Muss, H B; Vogel, V G; Somerfield, M R

    1999-03-01

    To determine an effective, evidence-based, postoperative surveillance strategy for the detection and treatment of recurrent breast cancer. Tests are recommended only if they have an impact on the outcomes specified by American Society of Clinical Oncology (ASCO) for clinical practice guidelines. All tests described in the literature for postoperative monitoring were considered. In addition, the data were critically evaluated to determine the optimal frequency of monitoring. Outcomes of interest include overall and disease-free survival, quality of life, toxicity reduction, and secondarily cost-effectiveness. A search was performed to determine all relevant articles published over the past 20 years on the efficacy of surveillance testing for breast cancer recurrence. These publications comprised both retrospective and prospective studies. Levels of evidence and guideline grades were rated by a standard process. More weight was given to studies that tested a hypothesis directly relating testing to one of the primary outcomes in a randomized design. The possible consequences of false-positive and -negative tests were considered in evaluating a preference for one of two tests providing similar information. Cost alone was not a determining factor. The attached guidelines and text summarize the updated recommendations of the ASCO breast cancer expert panel. Data are sufficient to recommend monthly breast self-examination, annual mammography of the preserved and contralateral breast, and a careful history and physical examination every 3 to 6 months for 3 years, then every 6 to 12 months for 2 years, then annually. Data are not sufficient to recommend routine bone scans, chest radiographs, hematologic blood counts, tumor markers (carcinoembryonic antigen, cancer antigen [CA] 15-5, and CA 27.29), liver ultrasonograms, or computed tomography scans. The recommendations of the breast cancer expert panel were evaluated and supported by the ASCO Health Services Research

  13. The contribution of limited-resource countries to the American Society of Clinical Oncology annual meetings.

    PubMed

    Masmoudi, Amine

    2009-10-01

    Limited-resource countries (LRCs) are underrepresented in biomedical research, and data with respect to oncology are lacking. The aim of the present study was to assess the participation of LRCs in the American Society of Clinical Oncology (ASCO) annual meetings. We analyzed the characteristics of abstracts originating from LRCs presented at the 2005-2007 ASCO meetings. We used a logistic regression model to identify country characteristics associated with contributions to the meetings. Eight percent of abstracts were generated by authors from LRCs. Abstracts from LRCs, compared with abstracts originating from high-income countries (HICs), were less commonly scheduled for oral and poster presentations (1.4% and 26.8% vs 8.8% and 52.8%, respectively; P < 0.001), and were less likely to report industry-provided funding (2.0% vs 12.7%; P < 0.001). However, the presentation type and the rate of reporting industry funding did not significantly differ between HIC abstracts and LRC abstracts involving one or more coauthors from HICs. In multivariate analysis, ASCO-related characteristics, but not geoeconomic parameters, were significantly predictive of country participation in the meetings. These data show that the contribution of LRCs to ASCO annual meetings is very low. Although abstracts originating from LRCs involving authors from HICs were associated with a higher-impact type of presentation, their relevance to the cancer care concerns of LRCs remains to be ascertained.

  14. American Society of Clinical Oncology Policy Statement Update: Genetic and Genomic Testing for Cancer Susceptibility.

    PubMed

    Robson, Mark E; Bradbury, Angela R; Arun, Banu; Domchek, Susan M; Ford, James M; Hampel, Heather L; Lipkin, Stephen M; Syngal, Sapna; Wollins, Dana S; Lindor, Noralane M

    2015-11-01

    The American Society of Clinical Oncology (ASCO) has long affirmed that the recognition and management of individuals with an inherited susceptibility to cancer are core elements of oncology care. ASCO released its first statement on genetic testing in 1996 and updated that statement in 2003 and 2010 in response to developments in the field. In 2014, the Cancer Prevention and Ethics Committees of ASCO commissioned another update to reflect the impact of advances in this area on oncology practice. In particular, there was an interest in addressing the opportunities and challenges arising from the application of massively parallel sequencing-also known as next-generation sequencing-to cancer susceptibility testing. This technology introduces a new level of complexity into the practice of cancer risk assessment and management, requiring renewed effort on the part of ASCO to ensure that those providing care to patients with cancer receive the necessary education to use this new technology in the most effective, beneficial manner. The purpose of this statement is to explore the challenges of new and emerging technologies in cancer genetics and provide recommendations to ensure their optimal deployment in oncology practice. Specifically, the statement makes recommendations in the following areas: germline implications of somatic mutation profiling, multigene panel testing for cancer susceptibility, quality assurance in genetic testing, education of oncology professionals, and access to cancer genetic services.

  15. American Society of Clinical Oncology National Census of Oncology Practices: preliminary report.

    PubMed

    Forte, Gaetano J; Hanley, Amy; Hagerty, Karen; Kurup, Anupama; Neuss, Michael N; Mulvey, Therese M

    2013-01-01

    In response to reports of increasing financial and administrative burdens on oncology practices and a lack of systematic information related to these issues, American Society of Clinical Oncology (ASCO) leadership started an effort to collect key practice-level data from all oncology practices in the United States. The result of the effort is the ASCO National Census of Oncology Practices (Census) launched in June 2012. The initial Census work involved compiling an inventory of oncology practices from existing lists of oncology physicians in the United States. A comprehensive, online data collection instrument was developed, which covered a number of areas, including practice characteristics (staffing configuration, organizational structure, patient mix and volume, types of services offered); organizational, staffing, and service changes over the past 12 months; and an assessment of the likelihood that the practice would experience organizational, staffing, and service changes in the next 12 months. More than 600 practices participated in the Census by providing information. In this article, we present preliminary highlights from the data gathered to date. We found that practice size was related to having experienced practice mergers, hiring additional staff, and increasing staff pay in the past 12 months, that geographic location was related to having experienced hiring additional staff, and that practices in metropolitan areas were more likely to have experienced practice mergers in the past 12 months than those in nonmetropolitan areas. We also found that practice size and geographic location were related to higher likelihoods of anticipating practice mergers, sales, and purchases in the future.

  16. Pediatric parenteral nutrition: clinical practice guidelines from the Spanish Society of Parenteral and Enteral Nutrition (SENPE), the Spanish Society of Pediatric Gastroenterology, Hepatology and Nutrition (SEGHNP) and the Spanish Society of Hospital Pharmacy (SEFH)

    PubMed

    Pedrón Giner, Consuelo; Cuervas-Mons Vendrell, Margarita; Galera Martínez, Rafael; Gómez López, Lilianne; Gomis Muñoz, Pilar; Irastorza Terradillos, Iñaki; Martínez Costa, Cecilia; Moreno Villares, José Manuel; Pérez-Portabella Maristany, Cleofé; Pozas Del Río, M ª Teresa; Redecillas Ferreiro, Susana E; Prieto Bozano, Gerardo; Grupo de Estandarización de la Senpe, Senpe

    2017-06-05

    Introduction:Parenteral nutrition (PN) in childhood is a treatment whose characteristics are highly variable depending on the age and pathology of the patient. Material and methods: The Standardization and Protocols Group of the Spanish Society for Parenteral and Enteral Nutrition (SENPE) is an interdisciplinary group formed by members of the SENPE, the Spanish Society of Gastroenterology, Hepatology and Pediatric Nutrition (SEGHNP) and the Spanish Society of Hospital Pharmacy (SEFH) that intends to update this issue. For this, a detailed review of the literature has been carried out, looking for the evidences that allow us to elaborate a Clinical Practice Guide following the criteria of the Oxford Center for Evidence-Based Medicine. Results: This manuscript summarizes the recommendations regarding indications, access routes, requirements, modifi cations in special situations, components of the mixtures, prescription and standardization, preparation, administration, monitoring, complications and home NP. The complete document is published as a monographic number. Conclusions: This guide is intended to support the prescription of pediatric PN. It provides the basis for rational decisions in the context of the existing evidence. No guidelines can take into account all of the often compelling individual clinical circumstances.

  17. HER2 Testing and Clinical Decision Making in Gastroesophageal Adenocarcinoma: Guideline From the College of American Pathologists, American Society for Clinical Pathology, and the American Society of Clinical Oncology.

    PubMed

    Bartley, Angela N; Washington, Mary Kay; Colasacco, Carol; Ventura, Christina B; Ismaila, Nofisat; Benson, Al B; Carrato, Alfredo; Gulley, Margaret L; Jain, Dhanpat; Kakar, Sanjay; Mackay, Helen J; Streutker, Catherine; Tang, Laura; Troxell, Megan; Ajani, Jaffer A

    2017-02-01

    Context ERBB2 (erb-b2 receptor tyrosine kinase 2 or HER2) is currently the only biomarker established for selection of a specific therapy for patients with advanced gastroesophageal adenocarcinoma (GEA). However, there are no comprehensive guidelines for the assessment of HER2 in patients with GEA. Objectives To establish an evidence-based guideline for HER2 testing in patients with GEA, formalize the algorithms for methods to improve the accuracy of HER2 testing while addressing which patients and tumor specimens are appropriate, and to provide guidance on clinical decision making. Design The College of American Pathologists (CAP), American Society for Clinical Pathology (ASCP), and the American Society of Clinical Oncology (ASCO) convened an Expert Panel to conduct a systematic review of the literature to develop an evidence-based guideline with recommendations for optimal HER2 testing in patients with GEA. Results The Panel is proposing 11 recommendations with strong agreement from the open comment participants. Recommendations The Panel recommends that tumor specimen(s) from all patients with advanced GEA, who are candidates for HER2-targeted therapy, should be assessed for HER2 status before the initiation of HER2-targeted therapy. Clinicians should offer combination chemotherapy and an HER2-targeted agent as initial therapy for all patients with HER2-positive advanced GEA. For pathologists, guidance is provided for morphologic selection of neoplastic tissue, testing algorithms, scoring methods, interpretation and reporting of results, and laboratory quality assurance. Conclusion This guideline provides specific recommendations for assessment of HER2 in patients with advanced GEA while addressing pertinent technical issues and clinical implications of the results.

  18. Venous thromboembolism prophylaxis and treatment in patients with cancer: american society of clinical oncology clinical practice guideline update 2014.

    PubMed

    Lyman, Gary H; Bohlke, Kari; Khorana, Alok A; Kuderer, Nicole M; Lee, Agnes Y; Arcelus, Juan Ignacio; Balaban, Edward P; Clarke, Jeffrey M; Flowers, Christopher R; Francis, Charles W; Gates, Leigh E; Kakkar, Ajay K; Key, Nigel S; Levine, Mark N; Liebman, Howard A; Tempero, Margaret A; Wong, Sandra L; Somerfield, Mark R; Falanga, Anna

    2015-02-20

    To provide current recommendations about the prophylaxis and treatment of venous thromboembolism (VTE) in patients with cancer. PubMed and the Cochrane Library were searched for randomized controlled trials, systematic reviews, meta-analyses, and clinical practice guidelines from November 2012 through July 2014. An update committee reviewed the identified abstracts. Of the 53 publications identified and reviewed, none prompted a change in the 2013 recommendations. Most hospitalized patients with active cancer require thromboprophylaxis throughout hospitalization. Routine thromboprophylaxis is not recommended for patients with cancer in the outpatient setting. It may be considered for selected high-risk patients. Patients with multiple myeloma receiving antiangiogenesis agents with chemotherapy and/or dexamethasone should receive prophylaxis with either low-molecular weight heparin (LMWH) or low-dose aspirin. Patients undergoing major surgery should receive prophylaxis starting before surgery and continuing for at least 7 to 10 days. Extending prophylaxis up to 4 weeks should be considered in those undergoing major abdominal or pelvic surgery with high-risk features. LMWH is recommended for the initial 5 to 10 days of treatment for deep vein thrombosis and pulmonary embolism as well as for long-term secondary prophylaxis (at least 6 months). Use of novel oral anticoagulants is not currently recommended for patients with malignancy and VTE because of limited data in patients with cancer. Anticoagulation should not be used to extend survival of patients with cancer in the absence of other indications. Patients with cancer should be periodically assessed for VTE risk. Oncology professionals should educate patients about the signs and symptoms of VTE. © 2015 by American Society of Clinical Oncology.

  19. Breast cancer follow-up and management after primary treatment: American Society of Clinical Oncology clinical practice guideline update.

    PubMed

    Khatcheressian, James L; Hurley, Patricia; Bantug, Elissa; Esserman, Laura J; Grunfeld, Eva; Halberg, Francine; Hantel, Alexander; Henry, N Lynn; Muss, Hyman B; Smith, Thomas J; Vogel, Victor G; Wolff, Antonio C; Somerfield, Mark R; Davidson, Nancy E

    2013-03-01

    To provide recommendations on the follow-up and management of patients with breast cancer who have completed primary therapy with curative intent. To update the 2006 guideline of the American Society of Clinical Oncology (ASCO), a systematic review of the literature published from March 2006 through March 2012 was completed using MEDLINE and the Cochrane Collaboration Library. An Update Committee reviewed the evidence to determine whether the recommendations were in need of updating. There were 14 new publications that met inclusion criteria: nine systematic reviews (three included meta-analyses) and five randomized controlled trials. After its review and analysis of the evidence, the Update Committee concluded that no revisions to the existing ASCO recommendations were warranted. Regular history, physical examination, and mammography are recommended for breast cancer follow-up. Physical examinations should be performed every 3 to 6 months for the first 3 years, every 6 to 12 months for years 4 and 5, and annually thereafter. For women who have undergone breast-conserving surgery, a post-treatment mammogram should be obtained 1 year after the initial mammogram and at least 6 months after completion of radiation therapy. Thereafter, unless otherwise indicated, a yearly mammographic evaluation should be performed. The use of complete blood counts, chemistry panels, bone scans, chest radiographs, liver ultrasounds, pelvic ultrasounds, computed tomography scans, [(18)F]fluorodeoxyglucose-positron emission tomography scans, magnetic resonance imaging, and/or tumor markers (carcinoembryonic antigen, CA 15-3, and CA 27.29) is not recommended for routine follow-up in an otherwise asymptomatic patient with no specific findings on clinical examination.

  20. Executive Summary: Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis.

    PubMed

    Nahid, Payam; Dorman, Susan E; Alipanah, Narges; Barry, Pennan M; Brozek, Jan L; Cattamanchi, Adithya; Chaisson, Lelia H; Chaisson, Richard E; Daley, Charles L; Grzemska, Malgosia; Higashi, Julie M; Ho, Christine S; Hopewell, Philip C; Keshavjee, Salmaan A; Lienhardt, Christian; Menzies, Richard; Merrifield, Cynthia; Narita, Masahiro; O'Brien, Rick; Peloquin, Charles A; Raftery, Ann; Saukkonen, Jussi; Schaaf, H Simon; Sotgiu, Giovanni; Starke, Jeffrey R; Migliori, Giovanni Battista; Vernon, Andrew

    2016-10-01

    The American Thoracic Society, Centers for Disease Control and Prevention, and Infectious Diseases Society of America jointly sponsored the development of this guideline for the treatment of drug-susceptible tuberculosis, which is also endorsed by the European Respiratory Society and the US National Tuberculosis Controllers Association. Representatives from the American Academy of Pediatrics, the Canadian Thoracic Society, the International Union Against Tuberculosis and Lung Disease, and the World Health Organization also participated in the development of the guideline. This guideline provides recommendations on the clinical and public health management of tuberculosis in children and adults in settings in which mycobacterial cultures, molecular and phenotypic drug susceptibility tests, and radiographic studies, among other diagnostic tools, are available on a routine basis. For all recommendations, literature reviews were performed, followed by discussion by an expert committee according to the Grading of Recommendations, Assessment, Development and Evaluation methodology. Given the public health implications of prompt diagnosis and effective management of tuberculosis, empiric multidrug treatment is initiated in almost all situations in which active tuberculosis is suspected. Additional characteristics such as presence of comorbidities, severity of disease, and response to treatment influence management decisions. Specific recommendations on the use of case management strategies (including directly observed therapy), regimen and dosing selection in adults and children (daily vs intermittent), treatment of tuberculosis in the presence of HIV infection (duration of tuberculosis treatment and timing of initiation of antiretroviral therapy), as well as treatment of extrapulmonary disease (central nervous system, pericardial among other sites) are provided. The development of more potent and better-tolerated drug regimens, optimization of drug exposure for the

  1. Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis.

    PubMed

    Nahid, Payam; Dorman, Susan E; Alipanah, Narges; Barry, Pennan M; Brozek, Jan L; Cattamanchi, Adithya; Chaisson, Lelia H; Chaisson, Richard E; Daley, Charles L; Grzemska, Malgosia; Higashi, Julie M; Ho, Christine S; Hopewell, Philip C; Keshavjee, Salmaan A; Lienhardt, Christian; Menzies, Richard; Merrifield, Cynthia; Narita, Masahiro; O'Brien, Rick; Peloquin, Charles A; Raftery, Ann; Saukkonen, Jussi; Schaaf, H Simon; Sotgiu, Giovanni; Starke, Jeffrey R; Migliori, Giovanni Battista; Vernon, Andrew

    2016-10-01

    The American Thoracic Society, Centers for Disease Control and Prevention, and Infectious Diseases Society of America jointly sponsored the development of this guideline for the treatment of drug-susceptible tuberculosis, which is also endorsed by the European Respiratory Society and the US National Tuberculosis Controllers Association. Representatives from the American Academy of Pediatrics, the Canadian Thoracic Society, the International Union Against Tuberculosis and Lung Disease, and the World Health Organization also participated in the development of the guideline. This guideline provides recommendations on the clinical and public health management of tuberculosis in children and adults in settings in which mycobacterial cultures, molecular and phenotypic drug susceptibility tests, and radiographic studies, among other diagnostic tools, are available on a routine basis. For all recommendations, literature reviews were performed, followed by discussion by an expert committee according to the Grading of Recommendations, Assessment, Development and Evaluation methodology. Given the public health implications of prompt diagnosis and effective management of tuberculosis, empiric multidrug treatment is initiated in almost all situations in which active tuberculosis is suspected. Additional characteristics such as presence of comorbidities, severity of disease, and response to treatment influence management decisions. Specific recommendations on the use of case management strategies (including directly observed therapy), regimen and dosing selection in adults and children (daily vs intermittent), treatment of tuberculosis in the presence of HIV infection (duration of tuberculosis treatment and timing of initiation of antiretroviral therapy), as well as treatment of extrapulmonary disease (central nervous system, pericardial among other sites) are provided. The development of more potent and better-tolerated drug regimens, optimization of drug exposure for the

  2. Clinical Pharmacology in Denmark in 2016 - 40 Years with the Danish Society of Clinical Pharmacology and 20 Years as a Medical Speciality.

    PubMed

    Brøsen, Kim; Andersen, Stig Ejdrup; Borregaard, Jeanett; Christensen, Hanne Rolighed; Christensen, Palle Mark; Dalhoff, Kim Peder; Damkier, Per; Hallas, Jesper; Heisterberg, Jens; Jessen, Niels; Jürgens, Gesche; Kampmann, Jens Peter Konnerup; Laursen, Britt Elmedal; Laursen, Torben; Nielsen, Lars Peter; Poulsen, Birgitte Klindt; Poulsen, Henrik Enghusen; Andersen, Ljubica Vukelic; Senderovitz, Thomas; Sonne, Jesper

    2016-12-01

    The Danish Society of Clinical Pharmacology was founded in 1976, and mainly thanks to the persistent efforts of the society, clinical pharmacology became an independent medical speciality in Denmark in 1996. Since then, clinical pharmacology has gone from strength to strength. In the Danish healthcare system, clinical pharmacology has established itself as an indispensible part of the efforts to promote the rational, safe and economic use of drugs. Clinical pharmacologists are active in drug committees both in hospitals and in the primary sector. All clinical pharmacology centres offer a local medicines information service. Some centres have established an adverse drug effect manager function. Only one centre offers a therapeutic drug monitoring service. Clinical pharmacologists are responsible for the toxicological advice at the Danish Poison Information Centre at Bispebjerg University Hospital in the Capital Region. The Department of Clinical Pharmacology at Aarhus University Hospital works closely together with forensic toxicologists and pathologists, covering issues regarding illicit substances, forensic pharmacology, post-mortem toxicology, expert testimony and research. Therapeutic geriatric and psychiatric teach-inns for specialist and junior doctors are among the newest initiatives organized by clinical pharmacologists. Clinical pharmacologists work also in the Danish Medicines Agency and in the Danish pharmaceutical industry, and the latter has in particular a great growth potential for creating new jobs and career opportunities for clinical pharmacologists. As of July 2016, the Danish Society of Clinical Pharmacology has 175 members, and 70 of these are specialists in clinical pharmacology corresponding to approximately 2.5 specialists per 1000 doctors (Denmark has in total 28,000 doctors) or approximately 12 specialists per one million inhabitants. © 2016 Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).

  3. The organization of an educational program for specialists in clinical chemistry by the Greek Society of Clinical Chemistry-Clinical Biochemistry.

    PubMed

    Rizos, Demetrios; Karababa, Photini; Sarandakou, Angeliki; Panagiotakis, Othon; Haliassos, Alexander; Makris, Konstantinos; Psarra, Katerina; Bairaktari, Eleni; Spyropoulou, Panagiota; Nikolou, Chara; Galiatsatos, Nikolaos; Trakas, Nikolaos; Ferderigou, Angeliki; Seferiadis, Konstantin

    2011-01-01

    In Greece, there is no officially organized training in clinical chemistry for scientists. The Greek Society of Clinical Chemistry-Clinical Biochemistry decided to organize an intensive educational program of 18 seminars on clinical chemistry content as it is described in the EC4 Syllabus. The duration of each seminar was about 6 hours and consisted of 6 to 9 lectures. At the end of each seminar there was a voluntary written examination, comprised of 24 multiple choice questions. Successful completion of the Educational program was leading to a Certificate of Competence. Two cycles of the 18 seminars were performed: 1st cycle from October 2003 to December 2005 and 2nd cycle from March 2005 to October 2007. One hundred eighty nine colleagues was the mean attendance per seminar for the seminars of the 1st cycle and 38 colleagues for the seminars of the 2nd cycle. The mean participation to the examination for each seminar was almost 80% for the 1st cycle and 68% for the 2nd cycle. More than 80% of the participants performed Good or Very good in the examination in both cycles. It is estimated that more than 40% of the scientists who practice Clinical Chemistry in Greece, participated to this educational activity. This program is now provided as an e-learning application, and it is open for all scientists who want to follow the discipline of clinical chemistry.

  4. Health disparities in endocrine disorders: biological, clinical, and nonclinical factors--an Endocrine Society scientific statement.

    PubMed

    Golden, Sherita Hill; Brown, Arleen; Cauley, Jane A; Chin, Marshall H; Gary-Webb, Tiffany L; Kim, Catherine; Sosa, Julie Ann; Sumner, Anne E; Anton, Blair

    2012-09-01

    The aim was to provide a scholarly review of the published literature on biological, clinical, and nonclinical contributors to race/ethnic and sex disparities in endocrine disorders and to identify current gaps in knowledge as a focus for future research needs. PARTICIPANTS IN DEVELOPMENT OF SCIENTIFIC STATEMENT: The Endocrine Society's Scientific Statement Task Force (SSTF) selected the leader of the statement development group (S.H.G.). She selected an eight-member writing group with expertise in endocrinology and health disparities, which was approved by the Society. All discussions regarding the scientific statement content occurred via teleconference or written correspondence. No funding was provided to any expert or peer reviewer, and all participants volunteered their time to prepare this Scientific Statement. The primary sources of data on global disease prevalence are from the World Health Organization. A comprehensive literature search of PubMed identified U.S. population-based studies. Search strategies combining Medical Subject Headings terms and keyword terms and phrases defined two concepts: 1) racial, ethnic, and sex differences including specific populations; and 2) the specific endocrine disorder or condition. The search identified systematic reviews, meta-analyses, large cohort and population-based studies, and original studies focusing on the prevalence and determinants of disparities in endocrine disorders. consensus process: The writing group focused on population differences in the highly prevalent endocrine diseases of type 2 diabetes mellitus and related conditions (prediabetes and diabetic complications), gestational diabetes, metabolic syndrome with a focus on obesity and dyslipidemia, thyroid disorders, osteoporosis, and vitamin D deficiency. Authors reviewed and synthesized evidence in their areas of expertise. The final statement incorporated responses to several levels of review: 1) comments of the SSTF and the Advocacy and Public

  5. Health Disparities in Endocrine Disorders: Biological, Clinical, and Nonclinical Factors—An Endocrine Society Scientific Statement

    PubMed Central

    Brown, Arleen; Cauley, Jane A.; Chin, Marshall H.; Gary-Webb, Tiffany L.; Kim, Catherine; Sosa, Julie Ann; Sumner, Anne E.; Anton, Blair

    2012-01-01

    Objective: The aim was to provide a scholarly review of the published literature on biological, clinical, and nonclinical contributors to race/ethnic and sex disparities in endocrine disorders and to identify current gaps in knowledge as a focus for future research needs. Participants in Development of Scientific Statement: The Endocrine Society's Scientific Statement Task Force (SSTF) selected the leader of the statement development group (S.H.G.). She selected an eight-member writing group with expertise in endocrinology and health disparities, which was approved by the Society. All discussions regarding the scientific statement content occurred via teleconference or written correspondence. No funding was provided to any expert or peer reviewer, and all participants volunteered their time to prepare this Scientific Statement. Evidence: The primary sources of data on global disease prevalence are from the World Health Organization. A comprehensive literature search of PubMed identified U.S. population-based studies. Search strategies combining Medical Subject Headings terms and keyword terms and phrases defined two concepts: 1) racial, ethnic, and sex differences including specific populations; and 2) the specific endocrine disorder or condition. The search identified systematic reviews, meta-analyses, large cohort and population-based studies, and original studies focusing on the prevalence and determinants of disparities in endocrine disorders. Consensus Process: The writing group focused on population differences in the highly prevalent endocrine diseases of type 2 diabetes mellitus and related conditions (prediabetes and diabetic complications), gestational diabetes, metabolic syndrome with a focus on obesity and dyslipidemia, thyroid disorders, osteoporosis, and vitamin D deficiency. Authors reviewed and synthesized evidence in their areas of expertise. The final statement incorporated responses to several levels of review: 1) comments of the SSTF and the

  6. Hot topics and landmark studies from the 43rd annual meeting of the American Society of Clinical Oncology.

    PubMed

    Puglisi, Fabio; Aprile, Giuseppe; Fasola, Gianpiero

    2008-02-01

    The results of several preclinical and clinical studies were reported by oncology professionals at the 43rd American Society of Clinical Oncology (ASCO) meeting, the largest international forum in which the latest achievements in cancer research are annually presented. The central theme this year was 'Translating Research into Practice', emphasizing the goal of forging stronger links between basic research and clinical practice. This review offers a critical, summarized selection of several of the foremost studies presented at the meeting. The focus is on the findings from randomized phase III trials that, in the authors' opinion, are most likely to have an immediate effect on clinical practice.

  7. [American Society of Clinical Oncology (ASCO) 2011 essential data: the editorial board of the Bulletin du Cancer point of view].

    PubMed

    Vignot, Stéphane; Bay, Jacques-Olivier; Blay, Jean-Yves; Gonçalves, Anthony; Massard, Christophe; Thariat, Juliette; Wislez, Marie; André, Thierry

    2011-12-01

    Many data are presented each year during the American Society of Clinical Oncology meeting, redrawing the state of knowledge in oncology and hematology. This article proposed by the editorial board of the Bulletin du Cancer proposes to discuss new information with a drop of a few months with the aim of trying to identify the results that can have an immediate or future impact on clinical practice.

  8. Revisions to the 2009 American Society of Clinical Oncology/Oncology Nursing Society chemotherapy administration safety standards: expanding the scope to include inpatient settings.

    PubMed

    Jacobson, Joseph O; Polovich, Martha; Gilmore, Terry R; Schulmeister, Lisa; Esper, Peg; Lefebvre, Kristine B; Neuss, Michael N

    2012-01-01

    In November 2009, the American Society of Clinical Oncology (ASCO) and the Oncology Nursing Society (ONS) jointly published a set of 31 voluntary chemotherapy safety standards for adult patients with cancer, as the end result of a highly structured, multistakeholder process. The standards were explicitly created to address patient safety in the administration of parenteral and oral chemotherapeutic agents in outpatient oncology settings. In January 2011, a workgroup consisting of ASCO and ONS members was convened to review feedback received since publication of the standards, to address interim changes in practice, and to modify the standards as needed. The most significant change to the standards is to extend their scope to the inpatient setting. This change reflects the conviction that the same standards for chemotherapy administration safety should apply in all settings. The proposed set of standards has been approved by the Board of Directors for both ASCO and ONS and has been posted for public comment. Comments were used as the basis for final editing of the revised standards. The workgroup recognizes that the safety of oral chemotherapy usage, nononcology medication reconciliation, and home chemotherapy administration are not adequately addressed in the original or revised standards. A separate process, cosponsored by ASCO and ONS, will address the development of safety standards for these areas.

  9. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline.

    PubMed

    Bhasin, Shalender; Cunningham, Glenn R; Hayes, Frances J; Matsumoto, Alvin M; Snyder, Peter J; Swerdloff, Ronald S; Montori, Victor M

    2010-06-01

    Our objective was to update the guidelines for the evaluation and treatment of androgen deficiency syndromes in adult men published previously in 2006. The Task Force was composed of a chair, selected by the Clinical Guidelines Subcommittee of The Endocrine Society, five additional experts, a methodologist, and a medical writer. The Task Force received no corporate funding or remuneration. We recommend making a diagnosis of androgen deficiency only in men with consistent symptoms and signs and unequivocally low serum testosterone levels. We suggest the measurement of morning total testosterone level by a reliable assay as the initial diagnostic test. We recommend confirmation of the diagnosis by repeating the measurement of morning total testosterone and, in some men in whom total testosterone is near the lower limit of normal or in whom SHBG abnormality is suspected by measurement of free or bioavailable testosterone level, using validated assays. We recommend testosterone therapy for men with symptomatic androgen deficiency to induce and maintain secondary sex characteristics and to improve their sexual function, sense of well-being, muscle mass and strength, and bone mineral density. We recommend against starting testosterone therapy in patients with breast or prostate cancer, a palpable prostate nodule or induration or prostate-specific antigen greater than 4 ng/ml or greater than 3 ng/ml in men at high risk for prostate cancer such as African-Americans or men with first-degree relatives with prostate cancer without further urological evaluation, hematocrit greater than 50%, untreated severe obstructive sleep apnea, severe lower urinary tract symptoms with International Prostate Symptom Score above 19, or uncontrolled or poorly controlled heart failure. When testosterone therapy is instituted, we suggest aiming at achieving testosterone levels during treatment in the mid-normal range with any of the approved formulations, chosen on the basis of the patient

  10. The clinical research office of the endourological society percutaneous nephrolithotomy global study: staghorn versus nonstaghorn stones.

    PubMed

    Desai, Mahesh; De Lisa, Antonello; Turna, Burak; Rioja, Jorge; Walfridsson, Helena; D'Addessi, Alessandro; Wong, Carson; Rosette On Behalf Of The Croes Pcnl Study Group, Jean

    2011-08-01

    The study compared characteristics and outcomes in patients with staghorn or nonstaghorn stones who were treated with percutaneous nephrolithotomy (PCNL) within the Clinical Research Office of the Endourological Society (CROES) PCNL Global Study. Data over a 1-year period from consecutively treated patients from 96 centers worldwide were collated. The following variables in patients with staghorn or nonstaghorn stones were compared: National prevalence, patient characteristics, access method, puncture frequency and outcomes, including bleeding rates, operative time, and duration of hospital stay. Data from 5335 eligible patients were collated; 1466 (27.5%) with staghorn and 3869 (72.5%) with nonstaghorn stones. Staghorn stone presentation varied between centers from 67% in Thailand to 13% in Argentina. The frequencies of previous procedures were similar between groups, but shockwave lithotripsy was less frequent in patients with staghorn stones compared with nonstaghorn (16.8% vs 22.6%) and positive preoperative urine cultures were more frequent in patients with staghorn than nonstaghorn stones (23.4% vs 13.1%). Patients with staghorn stones underwent multiple punctures more frequently than those with nonstaghorn stones (16.9% vs 5.0%). Postoperative fever, bleeding, and the need for blood transfusion were more frequent, the median operative time and duration of hospital stay were longer, while the proportion of patients remaining stone free was lower (56.9% vs 82.5%) in patients with staghorn than nonstaghorn stones. The proportion of patients with staghorn stones varies widely between centers. Stone-free rates were lower, complications more frequent, and operative time and hospital stay were longer in patients with staghorn stones.

  11. [Consensus clinical practice guidelines of the Andalusian Epilepsy Society on prescribing generic antiepileptic drugs].

    PubMed

    Cañadillas-Hidalgo, F M; Sánchez-Alvarez, J C; Serrano-Castro, P J; Mercadé-Cerdá, J M

    Pharmaceutical spending in Spain accounts for 1.2-1.4% of the gross domestic product and is increasing by 5-12% per year. One of the measures adopted by the government to cut this spending is the possible substitution of original prescribed drugs by generics. In the case of antiepileptic drugs (AED), which are characterised by a scant therapeutic margin, these steps have sparked a scientific debate about their repercussion on the control of epileptic patients. We propose to draw up a set of implicit evidence-based consensus practice guidelines concerning issues related with this topic. A selective search for quality scientific information on the subject was conducted on PubMed-Medline, Tripdatabase and the Biblioteca Cochrane Plus. The selected references were analysed and discussed by the authors, and the recommendations deriving from them were collected. A total of 21 primary documents and 16 practice guidelines, protocols or experts' recommendations were identified. Our recommendations were explicitly included at the end of the text. The Andalusian Epilepsy Society makes the following recommendations: 1) not replacing an innovative AED by its generic in a controlled patient; 2) beginning treatment with a generic AED in monotherapy or in association is acceptable; 3) not exchanging generic AED from different pharmaceutical companies; 4) explaining to the patient the rules governing the authorization of generics and the importance of avoiding exchanges between different generic AED; and 5) if there is some worsening of the clinical condition or side effects appear following the introduction of a generic, the causes must be investigated and communicated to the bodies responsible for pharmacovigilance.

  12. American Society of Clinical Oncology Position Statement on Obesity and Cancer

    PubMed Central

    Ligibel, Jennifer A.; Alfano, Catherine M.; Courneya, Kerry S.; Demark-Wahnefried, Wendy; Burger, Robert A.; Chlebowski, Rowan T.; Fabian, Carol J.; Gucalp, Ayca; Hershman, Dawn L.; Hudson, Melissa M.; Jones, Lee W.; Kakarala, Madhuri; Ness, Kirsten K.; Merrill, Janette K.; Wollins, Dana S.; Hudis, Clifford A.

    2014-01-01

    Rates of obesity have increased significantly over the last three decades in the United States and globally. In addition to contributing to heart disease and diabetes, obesity is a major unrecognized risk factor for cancer. Obesity is associated with worsened prognosis after cancer diagnosis and also negatively affects the delivery of systemic therapy, contributes to morbidity of cancer treatment, and may raise the risk of second malignancies and comorbidities. Research shows that the time after a cancer diagnosis can serve as a teachable moment to motivate individuals to adopt risk-reducing behaviors. For this reason, the oncology care team—the providers with whom a patient has the closest relationships in the critical period after a cancer diagnosis—is in a unique position to help patients lose weight and make other healthy lifestyle changes. The American Society of Clinical Oncology is committed to reducing the impact of obesity on cancer and has established a multipronged initiative to accomplish this goal by 1) increasing education and awareness of the evidence linking obesity and cancer; 2) providing tools and resources to help oncology providers address obesity with their patients; 3) building and fostering a robust research agenda to better understand the pathophysiology of energy balance alterations, evaluate the impact of behavior change on cancer outcomes, and determine the best methods to help cancer survivors make effective and useful changes in lifestyle behaviors; and 4) advocating for policy and systems change to address societal factors contributing to obesity and improve access to weight management services for patients with cancer. PMID:25273035

  13. Impact of trauma societies on the clinical care of polytrauma patients.

    PubMed

    Fingerhut, A; Boffard, K D

    2012-06-01

    Trauma societies have an influence on the management and outcome of polytrauma. Its contributions include setting up standard definitions, trauma registries, evidence-based medicine guidelines, and the creation of educational tools such as specific courses of trauma care and decision-making. Literature and web-based search of definitions and available information. The history of and accomplishments of trauma societies in the above-mentioned domains are reviewed, including the major trauma registries (Major Trauma Outcome Study, National Trauma Data Bank, The American Pediatric Surgical Association, the American Burn Association trauma, and the German Trauma Society trauma registries). Several learned societies in the field of trauma have created recommendations and/or guidelines concerning polytrauma (the Eastern Association for the Surgery of Trauma, The Society of Critical Care Medicine, and the German Trauma Society, Brain Trauma Foundation, and the Essential Trauma Care (EsTC) Guidelines). Several practical, hands-on courses and scoring systems for improving the quality of management of polytrauma patients have been founded and implemented in the past 35 years, including the Advanced Trauma Life Support (ATLS(®)) Course of the American College of Surgeons, the Definitive Surgical Trauma Care (DSTC(TM)) Course, the National Trauma Management Course (NTMC(TM) Course,) the Advanced Trauma Operative Management (ATOM) Course, and the European Trauma Course (ETC). Trauma and emergency care societies have made an elaborate, substantial contribution by developing trauma registries and creating specific guidelines courses on trauma care and decision-making.

  14. Are the Endocrine Society's Clinical Practice Guidelines on Androgen Therapy in Women misguided? A commentary.

    PubMed

    Traish, Abdulmaged; Guay, Andre T; Spark, Richard F

    2007-09-01

    The Endocrine Society Clinical Guidelines on Androgen Therapy in Women (henceforth referred to as the Guidelines) do not necessarily represent the opinion held by the many health-care professionals and clinicians who are specialized in the evaluation, diagnosis, and treatment of women's health in androgen insufficiency states. The recommendations provided in the published Guidelines are neither accurate nor complete. We disagree with the therapeutic nihilism promoted by these Guidelines. The members of the Guidelines Panel (henceforth referred to as the Panel), in their own disclaimer, stated that the Guidelines do not establish a standard of care. Based on data available in the contemporary literature, on the role of androgens in women's health, we provide in this commentary a point-by-point discussion of the arguments made by the Panel in arriving at their recommendations. It is our view that the Guidelines are not based on the preponderance of scientific evidence. Health-care professionals, physicians, and scientists often disagree when determining how best to address and manage new and emerging clinical issues. This is where we stand now as we endeavor to understand the role of androgens in a woman's health and welfare. Indeed, some basic facts are not in contention. All agree that dehydroepiandrosterone sulfate (DHEA-S) production from the adrenal gland begins during the preteen years, peaks in the mid 20s, then declines progressively over time. In contrast, ovarian androgen (i.e., testosterone) secretion commences at puberty, is sustained during a woman's peak reproductive years and declines as a woman ages, with a more rapid and steep decrease after surgical menopause. However, there are ample data to suggest that adrenal androgens play a role in the development of axillary and pubic hair, and that testosterone is critical for women's libido and sexual function. We take this opportunity to invite members of the Panel on Androgen Therapy in Women to discuss

  15. Clinical indications for computed tomographic colonography: European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastrointestinal and Abdominal Radiology (ESGAR) Guideline.

    PubMed

    Spada, Cristiano; Stoker, Jaap; Alarcon, Onofre; Barbaro, Federico; Bellini, Davide; Bretthauer, Michael; De Haan, Margriet C; Dumonceau, Jean-Marc; Ferlitsch, Monika; Halligan, Steve; Helbren, Emma; Hellstrom, Mikael; Kuipers, Ernst J; Lefere, Philippe; Mang, Thomas; Neri, Emanuele; Petruzziello, Lucio; Plumb, Andrew; Regge, Daniele; Taylor, Stuart A; Hassan, Cesare; Laghi, Andrea

    2014-10-01

    This is an official guideline of the European Society of Gastrointestinal Endoscopy (ESGE) and the European Society of Gastrointestinal and Abdominal Radiology (ESGAR). It addresses the clinical indications for the use of computed tomographic colonography (CTC). A targeted literature search was performed to evaluate the evidence supporting the use of CTC. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was adopted to define the strength of recommendations and the quality of evidence. Main recommendations 1 ESGE/ESGAR recommend computed tomographic colonography (CTC) as the radiological examination of choice for the diagnosis of colorectal neoplasia. ESGE/ESGAR do not recommend barium enema in this setting (strong recommendation, high quality evidence). 2 ESGE/ESGAR recommend CTC, preferably the same or next day, if colonoscopy is incomplete. Delay of CTC should be considered following endoscopic resection. In the case of obstructing colorectal cancer, preoperative contrast-enhanced CTC may also allow location or staging of malignant lesions (strong recommendation, moderate quality evidence). 3 When endoscopy is contraindicated or not possible, ESGE/ESGAR recommend CTC as an acceptable and equally sensitive alternative for patients with symptoms suggestive of colorectal cancer (strong recommendation, high quality evidence). 4 ESGE/ESGAR recommend referral for endoscopic polypectomy in patients with at least one polyp  ≥  6  mm in diameter detected at CTC. CTC surveillance may be clinically considered if patients do not undergo polypectomy (strong recommendation, moderate quality evidence). 5 ESGE/ESGAR do not recommend CTC as a primary test for population screening or in individuals with a positive first-degree family history of colorectal cancer (CRC). However, it may be proposed as a CRC screening test on an individual basis providing the screenee is adequately informed about test characteristics, benefits, and risks

  16. American Society of Clinical Oncology policy statement update: genetic testing for cancer susceptibility.

    PubMed

    2003-06-15

    As the leading organization representing cancer specialists involved in patient care and clinical research, the American Society of Clinical Oncology (ASCO) reaffirms its commitment to integrating cancer risk assessment and management, including molecular analysis of cancer predisposition genes, into the practice of oncology and preventive medicine. The primary goal of this effort is to foster expanded access to, and continued advances in, medical care provided to patients and families affected by hereditary cancer syndromes. The 1996 ASCO Statement on Genetic Testing for Cancer Susceptibility set forth specific recommendations relating to clinical practice, research needs, educational opportunities, requirement for informed consent, indications for genetic testing, regulation of laboratories, and protection from discrimination, as well as access to and reimbursement for cancer genetics services. In updating this Statement, ASCO endorses the following principles: Indications for Genetic Testing: ASCO recommends that genetic testing be offered when 1) the individual has personal or family history features suggestive of a genetic cancer susceptibility condition, 2) the test can be adequately interpreted, and 3) the results will aid in diagnosis or influence the medical or surgical management of the patient or family members at hereditary risk of cancer. ASCO recommends that genetic testing only be done in the setting of pre- and post-test counseling, which should include discussion of possible risks and benefits of cancer early detection and prevention modalities. Special Issues in Testing Children for Cancer Susceptibility: ASCO recommends that the decision to offer testing to potentially affected children should take into account the availability of evidence-based risk-reduction strategies and the probability of developing a malignancy during childhood. Where risk-reduction strategies are available or cancer predominantly develops in childhood, ASCO believes that

  17. Inside the 2016 American Society of Clinical Oncology Genitourinary Cancers Symposium: part 2 - prostate and bladder cancer.

    PubMed

    Buti, Sebastiano; Ciccarese, Chiara; Iacovelli, Roberto; Bersanelli, Melissa; Scarpelli, Marina; Lopez-Beltran, Antonio; Cheng, Liang; Montironi, Rodolfo; Tortora, Giampaolo; Massari, Francesco

    2016-09-01

    The American Society of Clinical Oncology Genitourinary Cancers Symposium, Moscone West Building, San Francisco, CA, USA, 7-9 January 2016 The American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, held in San Francisco (CA, USA), from 7 to 9 January 2016, focused on 'patient-centric care: translating research to results'. Every year, this meeting is a must for anyone studying genitourinary tumors to keep abreast of the most recent innovations in this field, exchange views on behaviors customarily adopted in daily clinical practice and discuss future topics of scientific research. This two-part report highlights the key themes presented at the 2016 ASCO Genitourinary Cancers Symposium, with part 1 reporting the main novelties of kidney cancer and part 2 discussing the most relevant issues which have emerged for bladder and prostate tumors.

  18. Clinical management and outcome of refractory asthma in the UK from the British Thoracic Society Difficult Asthma Registry.

    PubMed

    Sweeney, Joan; Brightling, Chris E; Menzies-Gow, Andrew; Niven, Robert; Patterson, Chris C; Heaney, Liam G

    2012-08-01

    Refractory asthma represents a significant unmet clinical need. Data from a national online registry audited clinical outcome in 349 adults with refractory asthma from four UK specialist centres in the British Thoracic Society Difficult Asthma Network. At follow-up, lung function improved, with a reduction in important healthcare outcomes, specifically hospital admission, unscheduled healthcare visits and rescue courses of oral steroids. The most frequent therapeutic intervention was maintenance oral corticosteroids and most steroid sparing agents (apart from omalizumab) demonstrated minimal steroid sparing benefit. A significant unmet clinical need remains in this group, specifically a requirement for therapies which reduce systemic steroid exposure.

  19. [Participation and support of clinical studies and other scientific investigations. Statement of the German Society for Pathology].

    PubMed

    Röcken, C; Höfler, H; Hummel, M; Meyermann, R; Zietz, C; Schirmacher, P

    2013-09-01

    Clinical studies and preclinical investigations are essential in order to test new therapies and diagnostics with the aim of sustained improvement in the treatment of patients. Fortunately, the number of clinical studies is continuously increasing and pathology and tissue-based research are included more often. The German Society for Pathology (DGP) and the pathologists it represents want to and can support this process and our clinical partners as best as possible as an equal partner. With our technologies and our specific expertise we can make a substantial contribution to the quality and the success of preclinical investigations, clinical studies and implementation of the results into clinical pathological diagnostics. In order to support this process the DGP has formulated a statement on the participation and support of clinical studies and other scientific investigations.

  20. Participation in and support of clinical studies and other scientific investigations - Statement of the German Society for Pathology.

    PubMed

    Röcken, Christoph; Höfler, Heinz; Hummel, Michael; Meyermann, Richard; Zietz, Christian; Schirmacher, Peter

    2014-11-01

    Clinical studies and preclinical investigations are essential in order to test new therapies and diagnostic techniques aimed at sustainable improvements in the treatment of patients. Fortunately, the number of clinical studies is continuously increasing and pathology and tissue-based research are more frequently involved. Pathologists are essential in this process and committed to support it by joining forces with our clinical partners. The investigative diagnostic technologies we apply to human cell and tissue samples and our specific expertise are essential contributions to the quality and success of preclinical investigations, clinical studies, and the implementation of results into clinical diagnostic pathology. In order to support this process, the German Society of Pathology has formulated a statement on the participation in and support of clinical studies and other scientific investigations with a special focus on tissue-based research. Copyright © 2014 Elsevier GmbH. All rights reserved.

  1. American Society of Clinical Oncology guidance statement: the cost of cancer care.

    PubMed

    Meropol, Neal J; Schrag, Deborah; Smith, Thomas J; Mulvey, Therese M; Langdon, Robert M; Blum, Diane; Ubel, Peter A; Schnipper, Lowell E

    2009-08-10

    Advances in early detection, prevention, and treatment have resulted in consistently falling cancer death rates in the United States. In parallel with these advances have come significant increases in the cost of cancer care. It is well established that the cost of health care (including cancer care) in the United States is growing more rapidly than the overall economy. In part, this is a result of the prices and rapid uptake of new agents and other technologies, including advances in imaging and therapeutic radiology. Conventional understanding suggests that high prices may reflect the costs and risks associated with the development, production, and marketing of new drugs and technologies, many of which are valued highly by physicians, patients, and payers. The increasing cost of cancer care impacts many stakeholders who play a role in a complex health care system. Our patients are the most vulnerable because they often experience uneven insurance coverage, leading to financial strain or even ruin. Other key groups include pharmaceutical manufacturers that pass along research, development, and marketing costs to the consumer; providers of cancer care who dispense increasingly expensive drugs and technologies; and the insurance industry, which ultimately passes costs to consumers. Increasingly, the economic burden of health care in general, and high-quality cancer care in particular, will be less and less affordable for an increasing number of Americans unless steps are taken to curb current trends. The American Society of Clinical Oncology (ASCO) is committed to improving cancer prevention, diagnosis, and treatment and eliminating disparities in cancer care through support of evidence-based and cost-effective practices. To address this goal, ASCO established a Cost of Care Task Force, which has developed this Guidance Statement on the Cost of Cancer Care. This Guidance Statement provides a concise overview of the economic issues facing stakeholders in the cancer

  2. Report on the 10th International Conference of the Asian Clinical Oncology Society (ACOS 2012).

    PubMed

    Kim, Yeul Hong; Yang, Han-Kwang; Kim, Tae Won; Lee, Jung Shin; Seong, Jinsil; Lee, Woo Yong; Ahn, Yong Chan; Lim, Ho Yeong; Won, Jong-Ho; Park, Kyong Hwa; Cho, Kyung Sam

    2013-04-01

    The 10th International Conference of the Asian Clinical Oncology Society (ACOS 2012) in conjunction with the 38th Annual Meeting of the Korean Cancer Association, was held on June 13 to 15 (3 days) 2012 at COEX Convention and Exhibition Center in Seoul, Korea. ACOS has a 20-year history starting from the first conference in Osaka, Japan, which was chaired by Prof. Tetsuo Taguchi and the ACOS conferences have since been conducted in Asian countries every 2 years. Under the theme of "Work Together to Make a Difference for Cancer Therapy in Asia", the 10th ACOS was prepared to discuss various subjects through a high-quality academic program, exhibition, and social events. The ACOS 2012 Committee was composed of the ACOS Organizing Committee, Honorary Advisors, Local Advisors, and ACOS 2012 Organizing Committee. The comprehensive academic program had a total of 92 sessions (3 Plenary Lectures, 1 Award Lectures, 1 Memorial Lectures, 9 Special Lectures, 15 Symposia, 1 Debate & Summary Sessions, 1 Case Conferences, 19 Educational Lectures, 1 Research & Development Session, 18 Satellite Symposia, 9 Meet the Professors, 14 Oral Presentations) and a total 292 presentations were delivered throughout the entire program. Amongst Free Papers, 462 research papers (110 oral presentations and 352 poster presentations) were selected to be presented. This conference was the largest of all ACOS conferences in its scale with around 1,500 participants from 30 countries. Furthermore, despite strict new financial policies and requirements governing fundraising alongside global economic stagnation, a total of 14 companies participated as sponsors and an additional 35 companies purchased 76 exhibition booths. Lastly, the conference social events provided attendees with a variety of opportunities to experience and enjoy Korea's rich culture and traditions during the Opening Ceremony, Welcome Reception, Invitee Dinner, Banquet, and Closing Ceremony. Overall, ACOS 2012 reinforced and promoted

  3. Tobacco control: reducing cancer incidence and saving lives. American Society of Clinical Oncology.

    PubMed

    1996-06-01

    The American Society of Clinical Oncology (ASCO) supports the elimination of tobacco products. Toward that goal, ASCO urges the adoption of national policy that strengthens regulation of the sale, promotion, and distribution of such products. To reduce cancer mortality, our regulatory policies must recognize that the nicotine within tobacco is an addictive substance, the use of which leads to 30% of all cancer deaths and a total of 419,000 deaths each year. Tobacco-related advertising and promotion should be banned. At a minimum, national policies should: ban billboards; limit advertising to black and white text only; prohibit the sale or giveaway of products that contain tobacco brand names or logos; prohibit brand name sponsorship of sporting or entertainment events; and require stronger and more prominent warning labels on all tobacco products. Despite existing state laws prohibiting sale of tobacco products to minors, children are able to buy such products easily. National regulation of the sale and distribution of tobacco products is necessary to eliminate children's access to tobacco. Where sales are permitted, they should be limited to face-to-face purchases by individuals 18 and older. Vending machines and other means of distributing tobacco without a face-to-face purchase should be outlawed. To the extent tobacco sales are allowed to continue, the federal government should mandate that the tobacco industry contribute substantial funds for a national public education campaign to prevent young people from smoking and other tobacco use. ASCO has long advocated a substantial increase (in the range of $2) in the federal excise tax on cigarettes and other tobacco products- a measure known to decrease consumption, particularly among children. Revenue from a tax on tobacco products should be used to support retraining for tobacco farmers, biomedical research, health care delivery, and antitobacco education. United State trade policies should discourage the export

  4. Interpretation and use of FRAX in clinical practice - position paper of the International Osteoporosis Foundation and the International Society for Clinical Densitometry

    USDA-ARS?s Scientific Manuscript database

    The International Osteoporosis Foundation (IOF) and the International Society for Clinical Densitometry (ISCD) appointed a joint Task Force to develop resource documents in order to make recommendations on how to improve FRAX and better inform clinicians who use FRAX. The Task Force met in November...

  5. EBM-based Clinical Guidelines for Pancreatic Cancer (2013) issued by the Japan Pancreas Society: a synopsis.

    PubMed

    Yamaguchi, Koji; Okusaka, Takuji; Shimizu, Kyoko; Furuse, Junji; Ito, Yoshinori; Hanada, Keiji; Shimosegawa, Tooru

    2014-10-01

    Clinical practice guidelines for pancreatic cancer based on evidence-based medicine (2006) were published by the Japan Pancreas Society (Committee for revision of clinical guidelines for pancreatic cancer) in March 2009 in Japanese, revised to Clinical Practice Guidelines for Pancreatic Cancer based on evidence-based medicine (2009) in July 2009 in Japanese and further revised to Clinical Practice Guidelines for Pancreatic Cancer (2013) in October 2013 in Japanese. These guidelines were established according to evidence-based medicine. A total of 629 papers were collected from among 4612 reports concerning pancreatic cancer listed in PubMed and Igakuchuo Zasshi between May 2007 and January 2011. This new set of guidelines was written by members of the Committee for the Revision of Clinical Practice Guidelines for Pancreatic Cancer in the Japan Pancreas Society. The guidelines provide an algorithm for the diagnosis (Fig. 1) and treatment (Fig. 2) of pancreatic cancer and address six subjects (Diagnosis, Surgery, Adjuvant therapy, Radiation therapy, Chemotherapy and stent therapy), with 35 clinical questions and 57 recommendations. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  6. Fathers and Adolescents: Developmental and Clinical Perspectives. Adolescence and Society Series.

    ERIC Educational Resources Information Center

    Shulman, Shmuel; Seiffge-Krenke, Inge

    The family itself and men's roles within traditional nuclear families are changing; non-custodial fathers, stepfathers, and absent fathers are commonplace. This book examines the relationships of fathers to their adolescent sons, and daughters, in the context of a changing society. Chapter one explores both the historical and the changing role of…

  7. Some personal thoughts on the Australasian Society of Clinical and Experimental Pharmacologists in the 1980s.

    PubMed

    Johnston, Graham A R

    2017-02-01

    There were a number of highly significant events regarding ASCEP in the 1980s: a tour of China by ASCEP pharmacologists; the Sydney IUPHAR Congress; and the initiation of the Australasian Visitor to the BPS scheme. ASCEP appointed a professional secretariat, established an investment portfolio, and initiated Special Interest Groups. The Society entered the 1990s welcoming toxicologists into the new ASCEPT.

  8. A golden anniversary: highlights of the 50th annual meeting of the American Society of Clinical Oncology

    PubMed Central

    McVie, Gordon; Nailor, Audrey

    2014-01-01

    The 50th Annual Meeting of the American Society of Clinical Oncology showed a shift in the culture of cancer research, moving towards multidisciplinary, integrated, and patient-centric work. Hormone-sensitive cancers were particularly highlighted at this meeting, and impressive strides were made in the previously underserved areas of the lung and thyroid cancer. Interestingly, immunotherapy was one of the strongest themes to emerge. PMID:25075218

  9. 8th Argentinean Bioengineering Society Conference (SABI 2011) and 7th Clinical Engineering Meeting

    NASA Astrophysics Data System (ADS)

    Meschino, Gustavo Javier; Ballarin, Virginia L.

    2011-12-01

    In September 2011, the Eighteenth Edition of the Argentinean Bioengineering Society Conference (SABI 2011) and Seventh Clinical Engineering Meeting were held in Mar del Plata, Argetina. The Mar del Plata SABI Regional and the School of Engineering of the Universidad Nacional de Mar del Plata invited All bioengineers, engineers, physicists, mathematicians, biologists, physicians and health professionals working in the field of Bioengineering to participate in this event. The overall objectives of the Conference were: To provide discussion of scientific research results in Bioengineering and Clinical Engineering. To promote technological development experiences. To strengthen the institutional and scientific communication links in the area of Bioengineering, mainly between Universities of Latin America. To encourage students, teachers, researchers and professionals to establish exchanges of experiences and knowledge. To provide biomedical engineering technology solutions to the society and contributing ideas for low cost care. Conference photograph Conference photograph Conference photograph Conference photograph EXECUTIVE COMMITTEE SABI 2011 Chair Dra Virginia L Ballarin Universidad Nacional de Mar del Plata Co-Chair Dra Teresita R Cuadrado Universidad Nacional de Mar del Plata - CONICET Local Comittee Dr Gustavo Abraham Universidad Nacional de Mar del Plata - CONICET Dra Josefina Ballarre Universidad Nacional de Mar del Plata - CONICET Dr Eduardo Blotta Universidad Nacional de Mar del Plata Dra Agustina Bouchet Universidad Nacional de Mar del Plata Dr Marcel Brun Universidad Nacional de Mar del Plata Dra Silvia Ceré Universidad Nacional de Mar del Plata - CONICET Dra Mariela Azul Gonzalez Universidad Nacional de Mar del Plata - CONICET Dra Lucia Isabel Passoni Universidad Nacional de Mar del Plata Dr Juan Ignacio Pastore Universidad Nacional de Mar del Plata - CONICET Dra Adriana Scandurra Universidad Nacional de Mar del Plata SCIENTIFIC ADVISORY COMMITTEE

  10. The American Society of Clinical Oncology Cancer Foundation Grants Program: a 25-year report and a look toward the future.

    PubMed

    King, Jennifer C; Lawrence, Theodore S; Murphy, Sharon B; Davidson, Nancy E; Mayer, Robert J

    2010-03-20

    The American Society of Clinical Oncology (ASCO) Grants Program began in 1984 with a single $16,000 grant to a young investigator for start-up research funding. In 2009, the Grants Program, now administered by The ASCO Cancer Foundation, awarded more than $6.5 million to 70 different investigators. This article, celebrating the 25th anniversary of this initiative, describes the history and evolution of the Grants Program, attempts to measure the impact of the program on clinical cancer research through an analysis of the career paths of past recipients, and addresses challenges that the program will face as it enters its second 25 years.

  11. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council.

    PubMed

    Chou, Roger; Gordon, Debra B; de Leon-Casasola, Oscar A; Rosenberg, Jack M; Bickler, Stephen; Brennan, Tim; Carter, Todd; Cassidy, Carla L; Chittenden, Eva Hall; Degenhardt, Ernest; Griffith, Scott; Manworren, Renee; McCarberg, Bill; Montgomery, Robert; Murphy, Jamie; Perkal, Melissa F; Suresh, Santhanam; Sluka, Kathleen; Strassels, Scott; Thirlby, Richard; Viscusi, Eugene; Walco, Gary A; Warner, Lisa; Weisman, Steven J; Wu, Christopher L

    2016-02-01

    Most patients who undergo surgical procedures experience acute postoperative pain, but evidence suggests that less than half report adequate postoperative pain relief. Many preoperative, intraoperative, and postoperative interventions and management strategies are available for reducing and managing postoperative pain. The American Pain Society, with input from the American Society of Anesthesiologists, commissioned an interdisciplinary expert panel to develop a clinical practice guideline to promote evidence-based, effective, and safer postoperative pain management in children and adults. The guideline was subsequently approved by the American Society for Regional Anesthesia. As part of the guideline development process, a systematic review was commissioned on various aspects related to various interventions and management strategies for postoperative pain. After a review of the evidence, the expert panel formulated recommendations that addressed various aspects of postoperative pain management, including preoperative education, perioperative pain management planning, use of different pharmacological and nonpharmacological modalities, organizational policies, and transition to outpatient care. The recommendations are based on the underlying premise that optimal management begins in the preoperative period with an assessment of the patient and development of a plan of care tailored to the individual and the surgical procedure involved. The panel found that evidence supports the use of multimodal regimens in many situations, although the exact components of effective multimodal care will vary depending on the patient, setting, and surgical procedure. Although these guidelines are based on a systematic review of the evidence on management of postoperative pain, the panel identified numerous research gaps. Of 32 recommendations, 4 were assessed as being supported by high-quality evidence, and 11 (in the areas of patient education and perioperative planning, patient

  12. An official multi-society statement: the role of clinical research results in the practice of critical care medicine.

    PubMed

    Tonelli, Mark R; Curtis, J Randall; Guntupalli, Kalpalatha K; Rubenfeld, Gordon D; Arroliga, Alejandro C; Brochard, Laurent; Douglas, Ivor S; Gutterman, David D; Hall, Jesse R; Kavanagh, Brian P; Mancebo, Jordi; Misak, Cheryl J; Simpson, Steven Q; Slutsky, Arthur S; Suffredini, Anthony F; Thompson, B Taylor; Ware, Lorraine B; Wheeler, Arthur P; Levy, Mitchell M

    2012-05-15

    While the results of clinical research are clearly valuable in the care of critically ill patients, the limitations of such information and the role of other forms of medical knowledge for clinical decision making have not been carefully examined. The leadership of three large professional societies representing critical care practitioners convened a diverse group representing a wide variety of views regarding the role of clinical research results in clinical practice to develop a document to serve as a basis for agreement and a framework for ongoing discussion. Consensus was reached on several issues. While the results of rigorous clinical research are important in arriving at the best course of action for an individual critically ill patient, other forms of medical knowledge, including clinical experience and pathophysiologic reasoning, remain essential. No single source of knowledge is sufficient to guide clinical decisions, nor does one kind of knowledge always take precedence over others. Clinicians will find clinical research compelling for a variety of reasons that go beyond study design. While clinical practice guidelines and protocols based upon clinical research may improve care and decrease variability in practice, clinicians must be able to understand and articulate the rationale as to why a particular protocol or guideline is used or why an alternative approach is taken. Making this clinical reasoning explicit is necessary to understand practice variability. Understanding the strengths and weaknesses of different kinds of medical knowledge for clinical decision making and factors beyond study design that make clinical research compelling to clinicians can provide a framework for understanding the role of clinical research in practice.

  13. The American Society for Clinical Investigation, 1952--1975: a personal perspective.

    PubMed

    Braunwald, Eugene

    2008-04-01

    In this perspective, I trace my experiences with the ASCI, beginning in 1952, when as a medical student I attended my first meeting, until 1975, when I completed my term as president of the Society. I focus attention on the sociological aspects of the Atlantic City meetings and the critically important role these meetings played in the evolution of academic medicine during the third quarter of the 20th century.

  14. Can the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS) be used to accurately report clinic total reproductive potential (TRP)?

    PubMed

    Stern, Judy E; Hickman, Timothy N; Kinzer, Donna; Penzias, Alan S; Ball, G David; Gibbons, William E

    2012-04-01

    To assess whether total reproductive potential (TRP), the chance of a live birth from each fresh cycle (fresh cycle plus frozen transfers), could be calculated from the national Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS) database and whether information not available in SART CORS resulted in significant changes to the TRP calculation. Retrospective study using SART CORS and clinic data. Three assisted reproductive technology clinics. Women undergoing ART. None. Two- and three-year TRPs for 2005 and 2006 were calculated according to patient age at cycle start by linking fresh to frozen cycles up to first live birth. Clinic records were used to adjust for (remove) frozen cycles that used more than one fresh cycle as a source of embryos and for any embryos donated to other patients or research or shipped to another facility before a live birth. TRP was higher than fresh per-cycle rates for most ages at all clinics, although accuracy was compromised when there were fewer than 20 cycles per category. Two- and 3-year TRPs differed in only 2 of 24 calculations. Adjusted TRPs differed less than three percentage points from unadjusted TRPs when volume was sufficient. Clinic TRP can be calculated from SART CORS. Data suggest that calculations of clinic TRP from the national dataset would be meaningful. Copyright © 2012 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  15. Ehlers-Danlos Society

    MedlinePlus

    ... Patient Expert Panel Volunteer Leaders The Ehlers-Danlos Society Center for EDS Research & Clinical Care Our History ... Online Communities Patient Resource Library The Ehlers-Danlos Society Center for EDS Research & Clinical Care Loose Connections ...

  16. Ehlers-Danlos Society

    MedlinePlus

    ... Scientific Board Staff Volunteer Leaders The Ehlers-Danlos Society Center for EDS Research & Clinical Care Our History ... Message Boards Patient Resource Library The Ehlers-Danlos Society Center for EDS Research & Clinical Care Loose Connections ...

  17. Clinically relevant variants - identifying, collecting, interpreting, and disseminating: the 2013 annual scientific meeting of the Human Genome Variation Society.

    PubMed

    Stanley, Christine M; Sunyaev, Shamil R; Greenblatt, Marc S; Oetting, William S

    2014-04-01

    The dramatic advances in genetic sequencing technologies used in research laboratories are now entering the clinic, and applications of whole-genome and whole-exome sequencing to disease diagnosis, predisposition, and treatment will soon be commonplace. However, the standards and methods for identifying clinically relevant variants are currently being debated and defined. Multiple agencies worldwide have recognized that we have reached an exciting and critical transition point into the clinic, and many important issues are being discussed that impact how genetic variation data in the clinic will be interpreted and used. The 2013 annual scientific meeting of the Human Genome Variation Society (HGVS) had as its main theme the discovery, interpretation, and dissemination of clinically relevant DNA variants. The meeting featured the continuously developing technology of databasing genetic variation and computational tools for allelic variant discovery. Attention was given to curating and integrating these data with clinical findings, including approaches to distinguish between functional alleles underlying clinical phenotypes and benign sequence variants and making data sources interoperable and functional for clinical diagnostic utility, citing examples in specific diseases.

  18. [Recommendations for the treatment of severe in-hospital pneumonia. Spanish Society of Critical, Coronary, and Intensive Medicine. Spanish Society for Respiratory Tract Pathology. Spanish Society of Infectious Diseases and Clinical Microbiology].

    PubMed

    Jordà Marcos, R; Torres Martí, A; Ariza Cardenal, F J; Alvarez Lerma, F; Barcenilla Gaite, F

    2004-10-01

    Given the sanitary repercussion of serious intrahospital pneumonia (SIP), representatives of three scientific societies (SEMICYUC; SEPAR and SEIMC) have developed during 2002 and 2003 a practical guide for its treatment. A task force was constituted to value five clinical situations related with the treatment of SIP: 1) critical revision of the existent guidelines and groups of risk definition; 2) entry criteria in ICU for SIP; 3) SIP treatment in function of the groups of risk; 4) special situations in SIP treatment, and 5) control treatment. After the bibliographical revision drafts were developed and discussed until the elaboration of the final document. It is necessary the stratification of the patients according to the presence or not of risk factors in order to make an appropriate use of treatments. SIP without risk factors can be treated with monotherapy with several antibiotics. SIP with risk factors specifies therapy combined with betalactamic plus aminoglycoside. Its substitution for a quinolon is a topic debate. Infections for multiresistance microorganisms require an individualized approach that can end up including the use of topical antibiotics. In SIP without microorganism isolation the use of a score system can be of utility in the taking of decisions. Revision of the therapeutic rule after 72 hours, carrying out the necessary adjustments according to the clinical evolution and microbiological results is necessary in all cases. Scientific evidence in the treatment of SIP allows the development of different strategies to achieve a higher efficiency both in antibiotic handling and in the control of its evolution.

  19. Trends in Twitter Use by Physicians at the American Society of Clinical Oncology Annual Meeting, 2010 and 2011

    PubMed Central

    Chaudhry, Aafia; Glodé, L. Michael; Gillman, Matt; Miller, Robert S.

    2012-01-01

    Purpose: Social media channels such as Twitter are gaining increasing acceptance as mechanisms for instantaneous scientific dialogue. Professional medical societies such as ASCO are using social media to expand the reach of scientific communications at and around their scientific meetings. This article examines the how Twitter use by oncologists expanded at the ASCO Annual Meetings from 2010 to 2011. Methods: In both years, tweets that were specifically generated by physicians and that incorporated the official meeting hashtag were harvested from the public domain, and a discourse analysis was performed by three independent raters. Follow-up surveys were conducted to assess physician attitudes toward Twitter and its potential role in clinical practice. Results: A combined total of 12,644 tweets were analyzed for 2010 and 2011. Although the number of physicians authoring tweets was small (14 in 2010, 34 in 2011), this group generated nearly 29% of the total meeting dialogue examined in this analysis in 2010 and 23% in 2011. Physicians used Twitter for reporting clinical news from scientific sessions, for discussions of treatment issues, for promotion, and to provide social commentary. The tangible impact of Twitter discussions on clinical practice remains unclear. Conclusion: Despite the 140-character limit, Twitter was successfully used by physicians at the 2010 and 2011 ASCO Annual Meetings to engage in clinical discussions, whether or not an author was on site as a live attendee. Twitter usage grew significantly from 2010 to 2011. Professional societies should monitor these phenomena to enhance annual meeting attendee user experience. PMID:22942812

  20. Trends in twitter use by physicians at the american society of clinical oncology annual meeting, 2010 and 2011.

    PubMed

    Chaudhry, Aafia; Glodé, L Michael; Gillman, Matt; Miller, Robert S

    2012-05-01

    Social media channels such as Twitter are gaining increasing acceptance as mechanisms for instantaneous scientific dialogue. Professional medical societies such as ASCO are using social media to expand the reach of scientific communications at and around their scientific meetings. This article examines the how Twitter use by oncologists expanded at the ASCO Annual Meetings from 2010 to 2011. In both years, tweets that were specifically generated by physicians and that incorporated the official meeting hashtag were harvested from the public domain, and a discourse analysis was performed by three independent raters. Follow-up surveys were conducted to assess physician attitudes toward Twitter and its potential role in clinical practice. A combined total of 12,644 tweets were analyzed for 2010 and 2011. Although the number of physicians authoring tweets was small (14 in 2010, 34 in 2011), this group generated nearly 29% of the total meeting dialogue examined in this analysis in 2010 and 23% in 2011. Physicians used Twitter for reporting clinical news from scientific sessions, for discussions of treatment issues, for promotion, and to provide social commentary. The tangible impact of Twitter discussions on clinical practice remains unclear. Despite the 140-character limit, Twitter was successfully used by physicians at the 2010 and 2011 ASCO Annual Meetings to engage in clinical discussions, whether or not an author was on site as a live attendee. Twitter usage grew significantly from 2010 to 2011. Professional societies should monitor these phenomena to enhance annual meeting attendee user experience.

  1. Diagnosis and treatment of polycystic ovary syndrome: an Endocrine Society clinical practice guideline.

    PubMed

    Legro, Richard S; Arslanian, Silva A; Ehrmann, David A; Hoeger, Kathleen M; Murad, M Hassan; Pasquali, Renato; Welt, Corrine K

    2013-12-01

    The aim was to formulate practice guidelines for the diagnosis and treatment of polycystic ovary syndrome (PCOS). An Endocrine Society-appointed Task Force of experts, a methodologist, and a medical writer developed the guideline. This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence. One group meeting, several conference calls, and e-mail communications enabled consensus. Committees and members of The Endocrine Society and the European Society of Endocrinology reviewed and commented on preliminary drafts of these guidelines. Two systematic reviews were conducted to summarize supporting evidence. We suggest using the Rotterdam criteria for diagnosing PCOS (presence of two of the following criteria: androgen excess, ovulatory dysfunction, or polycystic ovaries). Establishing a diagnosis of PCOS is problematic in adolescents and menopausal women. Hyperandrogenism is central to the presentation in adolescents, whereas there is no consistent phenotype in postmenopausal women. Evaluation of women with PCOS should exclude alternate androgen-excess disorders and risk factors for endometrial cancer, mood disorders, obstructive sleep apnea, diabetes, and cardiovascular disease. Hormonal contraceptives are the first-line management for menstrual abnormalities and hirsutism/acne in PCOS. Clomiphene is currently the first-line therapy for infertility; metformin is beneficial for metabolic/glycemic abnormalities and for improving menstrual irregularities, but it has limited or no benefit in treating hirsutism, acne, or infertility. Hormonal contraceptives and metformin are the treatment options in adolescents with PCOS. The role of weight loss in improving PCOS status per se is uncertain, but lifestyle intervention is beneficial in overweight/obese patients for other health benefits. Thiazolidinediones have an

  2. Diagnosis and Treatment of Polycystic Ovary Syndrome: An Endocrine Society Clinical Practice Guideline

    PubMed Central

    Legro, Richard S.; Arslanian, Silva A.; Ehrmann, David A.; Hoeger, Kathleen M.; Murad, M. Hassan; Pasquali, Renato; Welt, Corrine K.

    2013-01-01

    Objective: The aim was to formulate practice guidelines for the diagnosis and treatment of polycystic ovary syndrome (PCOS). Participants: An Endocrine Society-appointed Task Force of experts, a methodologist, and a medical writer developed the guideline. Evidence: This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence. Consensus Process: One group meeting, several conference calls, and e-mail communications enabled consensus. Committees and members of The Endocrine Society and the European Society of Endocrinology reviewed and commented on preliminary drafts of these guidelines. Two systematic reviews were conducted to summarize supporting evidence. Conclusions: We suggest using the Rotterdam criteria for diagnosing PCOS (presence of two of the following criteria: androgen excess, ovulatory dysfunction, or polycystic ovaries). Establishing a diagnosis of PCOS is problematic in adolescents and menopausal women. Hyperandrogenism is central to the presentation in adolescents, whereas there is no consistent phenotype in postmenopausal women. Evaluation of women with PCOS should exclude alternate androgen-excess disorders and risk factors for endometrial cancer, mood disorders, obstructive sleep apnea, diabetes, and cardiovascular disease. Hormonal contraceptives are the first-line management for menstrual abnormalities and hirsutism/acne in PCOS. Clomiphene is currently the first-line therapy for infertility; metformin is beneficial for metabolic/glycemic abnormalities and for improving menstrual irregularities, but it has limited or no benefit in treating hirsutism, acne, or infertility. Hormonal contraceptives and metformin are the treatment options in adolescents with PCOS. The role of weight loss in improving PCOS status per se is uncertain, but lifestyle intervention is beneficial in overweight

  3. The Society of Thoracic Surgeons Congenital Heart Surgery Database Mortality Risk Model: Part 2-Clinical Application.

    PubMed

    Jacobs, Jeffrey P; O'Brien, Sean M; Pasquali, Sara K; Gaynor, J William; Mayer, John E; Karamlou, Tara; Welke, Karl F; Filardo, Giovanni; Han, Jane M; Kim, Sunghee; Quintessenza, James A; Pizarro, Christian; Tchervenkov, Christo I; Lacour-Gayet, Francois; Mavroudis, Constantine; Backer, Carl L; Austin, Erle H; Fraser, Charles D; Tweddell, James S; Jonas, Richard A; Edwards, Fred H; Grover, Frederick L; Prager, Richard L; Shahian, David M; Jacobs, Marshall L

    2015-09-01

    The empirically derived 2014 Society of Thoracic Surgeons Congenital Heart Surgery Database Mortality Risk Model incorporates adjustment for procedure type and patient-specific factors. The purpose of this report is to describe this model and its application in the assessment of variation in outcomes across centers. All index cardiac operations in The Society of Thoracic Surgeons Congenital Heart Surgery Database (January 1, 2010, to December 31, 2013) were eligible for inclusion. Isolated patent ductus arteriosus closures in patients weighing less than or equal to 2.5 kg were excluded, as were centers with more than 10% missing data and patients with missing data for key variables. The model includes the following covariates: primary procedure, age, any prior cardiovascular operation, any noncardiac abnormality, any chromosomal abnormality or syndrome, important preoperative factors (mechanical circulatory support, shock persisting at time of operation, mechanical ventilation, renal failure requiring dialysis or renal dysfunction (or both), and neurological deficit), any other preoperative factor, prematurity (neonates and infants), and weight (neonates and infants). Variation across centers was assessed. Centers for which the 95% confidence interval for the observed-to-expected mortality ratio does not include unity are identified as lower-performing or higher-performing programs with respect to operative mortality. Included were 52,224 operations from 86 centers. Overall discharge mortality was 3.7% (1,931 of 52,224). Discharge mortality by age category was neonates, 10.1% (1,129 of 11,144); infants, 3.0% (564 of 18,554), children, 0.9% (167 of 18,407), and adults, 1.7% (71 of 4,119). For all patients, 12 of 86 centers (14%) were lower-performing programs, 67 (78%) were not outliers, and 7 (8%) were higher-performing programs. The 2014 Society of Thoracic Surgeons Congenital Heart Surgery Database Mortality Risk Model facilitates description of outcomes

  4. The Society of Thoracic Surgeons, The Society of Cardiovascular Anesthesiologists, and The American Society of ExtraCorporeal Technology: Clinical Practice Guidelines for Cardiopulmonary Bypass--Temperature Management During Cardiopulmonary Bypass.

    PubMed

    Engelman, Richard; Baker, Robert A; Likosky, Donald S; Grigore, Alina; Dickinson, Timothy A; Shore-Lesserson, Linda; Hammon, John W

    2015-08-01

    In order to improve our understanding of the evidence-based literature supporting temperature management during adult cardiopulmonary bypass, The Society of Thoracic Surgeons, the Society of Cardiovascular Anesthesiology and the American Society of ExtraCorporeal Technology tasked the authors to conduct a review of the peer-reviewed literature, including: 1) optimal site for temperature monitoring, 2) avoidance of hyperthermia, 3) peak cooling temperature gradient and cooling rate, and 4) peak warming temperature gradient and rewarming rate. Authors adopted the American College of Cardiology/American Heart Association method for development clinical practice guidelines, and arrived at the following recommendations: CLASS I RECOMMENDATIONS: a)The oxygenator arterial outlet blood temperature is recommended to be utilized as a surrogate for cerebral temperature measurement during CPB. (Class I, Level C) b)To monitor cerebral perfusate temperature during warming, it should be assumed that the oxygenator arterial outlet blood temperature under-estimates cerebral perfusate temperature. (Class I, Level C) c)Surgical teams should limit arterial outlet blood temperature to<37°C to avoid cerebral hyperthermia. (Class 1, Level C) d)Temperature gradients between the arterial outlet and venous inflow on the oxygenator during CPB cooling should not exceed 10°C to avoid generation of gaseous emboli. (Class 1, Level C) e)Temperature gradients between the arterial outlet and venous inflow on the oxygenator during CPB rewarming should not exceed 10°C to avoid out-gassing when blood is returned to the patient. (Class 1, Level C) CLASS IIa a)Pulmonary artery or nasopharyngeal temperature recording is reasonable for weaning and immediate post-bypass temperature measurement. (Class IIa, Level C)b)Rewarming when arterial blood outlet temperature ≥30° C: i.To achieve the desired temperature for separation from bypass, it is reasonable to maintain a temperature gradient between

  5. European Society of Clinical Pharmacy (ESCP) glossary of scientific terms: a tool for standardizing scientific jargon.

    PubMed

    Carollo, Anna; Rieutord, André; Launay-Vacher, Vincent

    2012-04-01

    This glossary is a tool for clinicians who have to confront topics in which medical, scientific and technical jargon is closely linked. It provides definitions for the key concepts and terms of pharmaceutical care, clinical pharmacy, and research in the health care system in clinical settings. It includes items that are not particularly technical, but that should be part of the know-how of staff working in medical and scientific fields. In fact, the glossary can also help clinical technicians who want to understand the precise definition of scientific terms, which often do not coincide with the ones used in the practice setting. PRINCIPAL GOALS AND OBJECTIVES: The aim of this glossary is to aid in the development of more standardized and established terminology for clinical pharmacy, facilitate communication among different stakeholders and, ultimately, contribute to a higher-quality health care system. The glossary contains 165 definitions of concepts and principles in clinical pharmacy, and terms widely used in this field. The criteria for the inclusion of terms were specific applications in health promotion, or terms used in other fields that have a specific meaning or application when used in reference to clinical activity. The glossary arose from the need to standardize terminology in the scientific field. It was not intended as a comprehensive listing that would include all medical terms, but as a useful tool for clinical pharmacists working in this area, and for users who occasionally encounter unusual, often hard to understand, terminology.

  6. The Infectious Diseases Society of America emerging infections network: bridging the gap between clinical infectious diseases and public health.

    PubMed

    Pillai, Satish K; Beekmann, Susan E; Santibanez, Scott; Polgreen, Philip M

    2014-04-01

    In 1995, the Centers for Disease Control and Prevention granted a Cooperative Agreement Program award to the Infectious Diseases Society of America to develop a provider-based emerging infections sentinel network, the Emerging Infections Network (EIN). Over the past 17 years, the EIN has evolved into a flexible, nationwide network with membership representing a broad cross-section of infectious disease physicians. The EIN has an active electronic mail conference (listserv) that facilitates communication among infectious disease providers and the public health community, and also sends members periodic queries (short surveys on infectious disease topics) that have addressed numerous topics relevant to both clinical infectious diseases and public health practice. The article reviews how the various functions of EIN contribute to clinical care and public health, identifies opportunities to further link clinical medicine and public health, and describes future directions for the EIN.

  7. The Infectious Diseases Society of America Emerging Infections Network: Bridging the Gap Between Clinical Infectious Diseases and Public Health

    PubMed Central

    Pillai, Satish K.; Beekmann, Susan E.; Santibanez, Scott; Polgreen, Philip M.

    2015-01-01

    In 1995, the Centers for Disease Control and Prevention granted a Cooperative Agreement Program award to the Infectious Diseases Society of America to develop a provider-based emerging infections sentinel network, the Emerging Infections Network (EIN). Over the past 17 years, the EIN has evolved into a flexible, nationwide network with membership representing a broad cross-section of infectious disease physicians. The EIN has an active electronic mail conference (listserv) that facilitates communication among infectious disease providers and the public health community, and also sends members periodic queries (short surveys on infectious disease topics) that have addressed numerous topics relevant to both clinical infectious diseases and public health practice. The article reviews how the various functions of EIN contribute to clinical care and public health, identifies opportunities to further link clinical medicine and public health, and describes future directions for the EIN. PMID:24403542

  8. Molecular Biomarkers for the Evaluation of Colorectal Cancer: Guideline From the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and the American Society of Clinical Oncology.

    PubMed

    Sepulveda, Antonia R; Hamilton, Stanley R; Allegra, Carmen J; Grody, Wayne; Cushman-Vokoun, Allison M; Funkhouser, William K; Kopetz, Scott E; Lieu, Christopher; Lindor, Noralane M; Minsky, Bruce D; Monzon, Federico A; Sargent, Daniel J; Singh, Veena M; Willis, Joseph; Clark, Jennifer; Colasacco, Carol; Rumble, R Bryan; Temple-Smolkin, Robyn; Ventura, Christina B; Nowak, Jan A

    2017-02-06

    Purpose Molecular testing of colorectal cancers (CRCs) to improve patient care and outcomes of targeted and conventional therapies has been the center of many recent studies, including clinical trials. Evidence-based recommendations for the molecular testing of CRC tissues to guide epidermal growth factor receptor (EGFR) -targeted therapies and conventional chemotherapy regimens are warranted in clinical practice. The purpose of this guideline is to develop evidence-based recommendations to help establish standard molecular biomarker testing for CRC through a systematic review of the literature. Methods The American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP), and the American Society of Clinical Oncology (ASCO) convened an Expert Panel to develop an evidence-based guideline to help establish standard molecular biomarker testing, guide targeted therapies, and advance personalized care for patients with CRC. A comprehensive literature search that included over 4,000 articles was conducted to gather data to inform this guideline. Results Twenty-one guideline statements (eight recommendations, 10 expert consensus opinions and three no recommendations) were established. Recommendations Evidence supports mutational testing for genes in the EGFR signaling pathway, since they provide clinically actionable information as negative predictors of benefit to anti-EGFR monoclonal antibody therapies for targeted therapy of CRC. Mutations in several of the biomarkers have clear prognostic value. Laboratory approaches to operationalize molecular testing for predictive and prognostic molecular biomarkers involve selection of assays, type of specimens to be tested, timing of ordering of tests and turnaround time for testing results. Additional information is available at: www.asco.org/CRC-markers-guideline and www.asco.org/guidelineswiki.

  9. American Society for Clinical Pharmacology and Therapeutics (ASCPT)-111th annual meeting. 17-20 March 2010, Atlanta, GA, USA.

    PubMed

    Veryard, Claire

    2010-05-01

    The 111th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, held in Atlanta, included topics covering disclosures of new data in the field of pharmacokinetics and drug interactions. This conference report highlights selected presentations on pharmacokinetic studies of several investigational drugs, including evatanepag (Pfizer Inc), AEG-33773 (Aegera Therapeutics Inc), JNJ-16269110 (Johnson & Johnson Pharmaceutical Research & Development LLC), PF-3716539 (ViiV Healthcare), MK-0736 (Merck & Co Inc), a combination of Ginkgo biloba and cilostazol (Renexin SK Chemicals Co Ltd), PP-101 (Pacific Pharmaceuticals Co Ltd), ACT-178882 (Acetlion Ltd/Merck & Co Inc) and edoxaban (Daiichi Sankyo Co Ltd).

  10. Improving clinical trials for cardiovascular diseases: a position paper from the Cardiovascular Round Table of the European Society of Cardiology.

    PubMed

    Jackson, Neville; Atar, Dan; Borentain, Maria; Breithardt, Günter; van Eickels, Martin; Endres, Matthias; Fraass, Uwe; Friede, Tim; Hannachi, Hakima; Janmohamed, Salim; Kreuzer, Jörg; Landray, Martin; Lautsch, Dominik; Le Floch, Chantal; Mol, Peter; Naci, Huseyin; Samani, Nilesh J; Svensson, Anders; Thorstensen, Cathrine; Tijssen, Jan; Vandzhura, Victoria; Zalewski, Andrew; Kirchhof, Paulus

    2016-03-01

    Cardiovascular disease is the most common cause of mortality and morbidity in the world, but the pharmaceutical industry's willingness to invest in this field has declined because of the many challenges involved with bringing new cardiovascular drugs to market, including late-stage failures, escalating regulatory requirements, bureaucracy of the clinical trial business enterprise, and limited patient access after approval. This contrasts with the remaining burden of cardiovascular disease in Europe and in the world. Thus, clinical cardiovascular research needs to adapt to address the impact of these challenges in order to ensure development of new cardiovascular medicines. The present paper is the outcome of a two-day workshop held by the Cardiovascular Round Table of the European Society of Cardiology. We propose strategies to improve development of effective new cardiovascular therapies. These can include (i) the use of biomarkers to describe patients who will benefit from new therapies more precisely, achieving better human target validation; (ii) targeted, mechanism-based approaches to drug development for defined populations; (iii) the use of information technology to simplify data collection and follow-up in clinical trials; (iv) streamlining adverse event collection and reducing monitoring; (v) extended patent protection or limited rapid approval of new agents to motivate investment in early phase development; and (vi) collecting data needed for health technology assessment continuously throughout the drug development process (before and after approval) to minimize delays in patient access. Collaboration across industry, academia, regulators, and payers will be necessary to enact change and to unlock the existing potential for cardiovascular clinical drug development. A coordinated effort involving academia, regulators, industry, and payors will help to foster better and more effective conduct of clinical cardiovascular trials, supporting earlier

  11. Self-expandable metal stents for obstructing colonic and extracolonic cancer: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline.

    PubMed

    van Hooft, Jeanin E; van Halsema, Emo E; Vanbiervliet, Geoffroy; Beets-Tan, Regina G H; DeWitt, John M; Donnellan, Fergal; Dumonceau, Jean-Marc; Glynne-Jones, Robert G T; Hassan, Cesare; Jiménez-Perez, Javier; Meisner, Søren; Muthusamy, V Raman; Parker, Michael C; Regimbeau, Jean-Marc; Sabbagh, Charles; Sagar, Jayesh; Tanis, Pieter J; Vandervoort, Jo; Webster, George J; Manes, Gianpiero; Barthet, Marc A; Repici, Alessandro

    2014-11-01

    This Guideline is an official statement of the European Society of Gastrointestinal Endoscopy (ESGE). This Guideline was also reviewed and endorsed by the Governing Board of the American Society for Gastrointestinal Endoscopy (ASGE). The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system was adopted to define the strength of recommendations and the quality of evidence. Main recommendations The following recommendations should only be applied after a thorough diagnostic evaluation including a contrast-enhanced computed tomography (CT) scan. 1 Prophylactic colonic stent placement is not recommended. Colonic stenting should be reserved for patients with clinical symptoms and imaging evidence of malignant large-bowel obstruction, without signs of perforation (strong recommendation, low quality evidence). 2 Colonic self-expandable metal stent (SEMS) placement as a bridge to elective surgery is not recommended as a standard treatment of symptomatic left-sided malignant colonic obstruction (strong recommendation, high quality evidence). 3 For patients with potentially curable but obstructing left-sided colonic cancer, stent placement may be considered as an alternative to emergency surgery in those who have an increased risk of postoperative mortality, I. e. American Society of Anesthesiologists (ASA) Physical Status ≥ III and/or age > 70 years (weak recommendation, low quality evidence). 4 SEMS placement is recommended as the preferred treatment for palliation of malignant colonic obstruction (strong recommendation, high quality evidence), except in patients treated or considered for treatment with antiangiogenic drugs (e. g. bevacizumab) (strong recommendation, low quality evidence).

  12. Doctor for patients or doctor for society? Comparative study of GPs' and psychiatrists' assessments of clinical practice.

    PubMed

    Lynöe, Niels; Mattsson, Bengt

    2004-12-01

    To study general practitioners' (GPs') inclination to be the advocate of their patients or representatives of the society. The GPs' opinions were compared with those of psychiatrists. A postal questionnaire with two case histories. Loyalty towards the social insurance or towards a patient in distress, and loyalty towards a patient seeking asylum or towards society were posited. The degree of distress and urgency of the patients' situation varied. A random sample of Swedish GPs (n =167) and psychiatrists (n =112). All doctors significantly changed their minds when asked to fake a psychiatric diagnosis compared with a somatic diagnosis. Compared with psychiatrists, general practitioners tend to be more pragmatic (p =0.016) and in addition female doctors in some cases in both groups seem to be more pragmatic (p =0.023). Good clinical practice seems to be of importance in both groups. If the patient's life is threatened doctors are, however, prepared to overrule their own professional interests. The interests of society seem not to have any strong support in either of the two groups or the two cases. GPs as well as psychiatrists find it less improper to fake a psychiatric diagnosis than to fake a somatic. GP tends to be more pragmatic than psychiatrists and female doctors tend to be more pragmatic than male in both groups.

  13. Endocardial Lead Extraction in the Polish Registry – clinical practice versus current Heart Rhythm Society consensus

    PubMed Central

    Kutarski, Andrzej; Mitkowski, Przemysław; Przybylski, Andrzej; Lewek, Joanna; Małecka, Barbara; Smukowski, Tomasz; Maciąg, Aleksander; Śmigielski, Janusz

    2013-01-01

    Introduction Over the last 10 years, there has been an increasing number of patients with pacemaker (PM) and cardioverter-defibrillator (ICD). This study is a retrospective analysis of indications for endocardial pacemaker and ICD lead extractions between 2003 and 2009 based on the experience of three Polish Referral Lead Extraction Centers. Material and methods Since 2003, the authors have consecutively retrospectively collected all cases and entered the information in the database. All patients which had indication for lead extraction according to Heart Rhythm Society Guidelines were included to final analyze. Between 2003 and 2005, the data were analyzed together. Since 2006, data have been collected and analyzed annually. Results In each year, a significant increase in lead extraction was observed. The main indications for LE were infections in 52.4% of patients. Nonfunctioning lead extraction constituted the second group of indications for LE in 29.7% of patients. During the registry period, the percentage of class I indications decreased from 80% in 2006 to only 47% in 2009. On the other hand, increasingly more leads were removed because of class 2, especially class 2b. In 2009, 40% of leads were extracted due to class 2b. Conclusions Polish Registry of Endocardial Lead Extraction 2003-2009, shows an increasing frequency of lead extraction. The main indication for LE is infection: systemic and pocket. An increase in class 2, especially 2b, LE indication in every center during the study period was found. PMID:24904658

  14. Clinical decisions in patients with diabetes and other cardiovascular risk factors. A statement of the Spanish Society of Internal Medicine.

    PubMed

    Gómez-Huelgas, R; Pérez-Jiménez, F; Serrano-Ríos, M; González-Santos, P; Román, P; Camafort, M; Conthe, P; García-Alegría, J; Guijarro, R; López-Miranda, J; Tirado-Miranda, R; Valdivielso, P

    2014-05-01

    Although the mortality associated to cardiovascular diseases (CVD) has been reduced in the last decades, CVD remains the main cause of mortality in Spain and they are associated with an important morbidity and a huge economic burden. The increasing prevalence of obesity and diabetes could be slowing down the mortality reduction in Spain. Clinicians have often difficulty making clinical decisions due to the multiple clinical guidelines available. Moreover, in the current context of economic crisis it is critical to promote an efficient use of diagnostic and therapeutic proceedings to ensure the viability of public health care systems. The Spanish Society of Internal Medicine (SEMI) has coordinated a consensus document to answer questions of daily practice with the aim of facilitating physicians' decision-making in the management of diabetes and cardiovascular risk factors from a cost-efficiency point of view.

  15. Canadian Society of Nephrology Commentary on the 2012 KDIGO clinical practice guideline for glomerulonephritis: management of glomerulonephritis in adults.

    PubMed

    Cybulsky, Andrey V; Walsh, Michael; Knoll, Greg; Hladunewich, Michelle; Bargman, Joanne; Reich, Heather; Humar, Atul; Samuel, Susan; Bitzan, Martin; Zappitelli, Michael; Dart, Allison; Mammen, Cherry; Pinsk, Maury; Muirhead, Norman

    2014-03-01

    The KDIGO (Kidney Disease: Improving Global Outcomes) clinical practice guideline for management of glomerulonephritis was recently released. The Canadian Society of Nephrology convened a working group to review the recommendations and comment on their relevancy and applicability to the Canadian context. A subgroup of adult nephrologists reviewed the guideline statements for management of glomerular disease in adults and agreed with most of the guideline statements developed by KDIGO. This commentary highlights areas for which there is lack of evidence and areas in need of translation of evidence into clinical practice. Areas of controversy or uncertainty, including the choice of second-line agents, are discussed in more detail. Existing practice variation also is addressed. The relevance of treatment recommendations to the Canadian practitioner is discussed.

  16. Canadian Society of Nephrology Commentary on the 2012 KDIGO clinical practice guideline for glomerulonephritis: management of nephrotic syndrome in children.

    PubMed

    Samuel, Susan; Bitzan, Martin; Zappitelli, Michael; Dart, Allison; Mammen, Cherry; Pinsk, Maury; Cybulsky, Andrey V; Walsh, Michael; Knoll, Greg; Hladunewich, Michelle; Bargman, Joanne; Reich, Heather; Humar, Atul; Muirhead, Norman

    2014-03-01

    The KDIGO (Kidney Disease: Improving Global Outcomes) clinical practice guideline for management of glomerulonephritis was recently released. The Canadian Society of Nephrology convened a working group to review the recommendations and comment on their relevancy and applicability to the Canadian context. A subgroup of pediatric nephrologists reviewed the guideline statements for management of childhood nephrotic syndrome and agreed with most of the guideline statements developed by KDIGO. This commentary highlights areas in which there is lack of evidence and areas in need of translation of evidence into clinical practice. Areas of controversy or uncertainty, including the length of corticosteroid therapy for the initial presentation and relapses, definitions of steroid resistance, and choice of second-line agents, are discussed in more detail. Existing practice variation is also addressed.

  17. Current perceptions of the term Clinical Pharmacy and its relationship to Pharmaceutical Care: a survey of members of the European Society of Clinical Pharmacy.

    PubMed

    Dreischulte, Tobias; Fernandez-Llimos, Fernando

    2016-12-01

    Background The definitions that are being used for the terms 'clinical pharmacy' and 'pharmaceutical care' seem to have a certain overlap. Responsibility for therapy outcomes seems to be especially linked to the latter term. Both terms need clarification before a proper definition of clinical pharmacy can be drafted. Objective To identify current disagreements regarding the term 'Clinical Pharmacy' and its relationship to 'Pharmaceutical Care' and to assess to which extent pharmacists with an interest in Clinical Pharmacy are willing to accept responsibility for drug therapy outcomes. Setting The membership of the European Society of Clinical Pharmacy. Methods A total of 1,285 individuals affiliated with the European Society of Clinical Pharmacy were invited by email to participate in an online survey asking participants to state whether certain professional activities, providers, settings, aims and general descriptors constituted (a) 'Clinical Pharmacy only', (b) 'Pharmaceutical Care only', (c) 'both' or (d) 'neither'. Further questions examined pharmacists' willingness to accept ethical or legal responsibility for drug therapy outcomes, under current and ideal working conditions. Main outcome measures Level of agreement with a number of statements. Results There was disagreement (<80% agreement among all participants) regarding 'Clinical Pharmacy' activities, whether non-pharmacists could provide 'Clinical Pharmacy' services, and whether such services could be provided in non-hospital settings. There was disagreement (<80% agreement among those linking items to Clinical Pharmacy) as to whether Pharmaceutical care also encompassed certain professional activities, constituted a scientific discipline and targeted cost effectiveness. The proportions of participants willing to accept legal responsibility under current/ideal working conditions were: safety (32.7%/64.3%), effectiveness (17.9%/49.2%), patient-centeredness (17.1%/46.2%), cost-effectiveness (20

  18. American Society of Clinical Oncology policy statement: the role of the oncologist in cancer prevention and risk assessment.

    PubMed

    Zon, Robin T; Goss, Elizabeth; Vogel, Victor G; Chlebowski, Rowan T; Jatoi, Ismail; Robson, Mark E; Wollins, Dana S; Garber, Judy E; Brown, Powel; Kramer, Barnett S

    2009-02-20

    Oncologists have a critical opportunity to utilize risk assessment and cancer prevention strategies to interrupt the initiation or progression of cancer in cancer survivors and individuals at high risk of developing cancer. Expanding knowledge about the natural history and prognosis of cancers positions oncologists to advise patients regarding the risk of second malignancies and treatment-related cancers. In addition, as recognized experts in the full spectrum of cancer care, oncologists are afforded opportunities for involvement in community-based cancer prevention activities. Although oncologists are currently providing many cancer prevention and risk assessment services to their patients, economic barriers exist, including inadequate or lack of insurance, that may compromise uniform patient access to these services. Additionally, insufficient reimbursement for existing and developing interventions may discourage patient access to these services. The American Society of Clinical Oncology (ASCO), the medical society representing cancer specialists involved in patient care and clinical research, is committed to supporting oncologists in their wide-ranging involvement in cancer prevention. This statement on risk assessment and prevention counseling, although not intended to be a comprehensive overview of cancer prevention describes the current role of oncologists in risk assessment and prevention; provides examples of risk assessment and prevention activities that should be offered by oncologists; identifies potential opportunities for coordination between oncologists and primary care physicians in prevention education and coordination of care for cancer survivors; describes ASCO's involvement in education and training of oncologists regarding prevention; and proposes improvement in the payment environment to encourage patient access to these services.

  19. The National Cancer Institute–American Society of Clinical Oncology Cancer Trial Accrual Symposium: Summary and Recommendations

    PubMed Central

    Denicoff, Andrea M.; McCaskill-Stevens, Worta; Grubbs, Stephen S.; Bruinooge, Suanna S.; Comis, Robert L.; Devine, Peggy; Dilts, David M.; Duff, Michelle E.; Ford, Jean G.; Joffe, Steven; Schapira, Lidia; Weinfurt, Kevin P.; Michaels, Margo; Raghavan, Derek; Richmond, Ellen S.; Zon, Robin; Albrecht, Terrance L.; Bookman, Michael A.; Dowlati, Afshin; Enos, Rebecca A.; Fouad, Mona N.; Good, Marjorie; Hicks, William J.; Loehrer, Patrick J.; Lyss, Alan P.; Wolff, Steven N.; Wujcik, Debra M.; Meropol, Neal J.

    2013-01-01

    Introduction: Many challenges to clinical trial accrual exist, resulting in studies with inadequate enrollment and potentially delaying answers to important scientific and clinical questions. Methods: The National Cancer Institute (NCI) and the American Society of Clinical Oncology (ASCO) cosponsored the Cancer Trial Accrual Symposium: Science and Solutions on April 29-30, 2010 to examine the state of accrual science related to patient/community, physician/provider, and site/organizational influences, and identify new interventions to facilitate clinical trial enrollment. The symposium featured breakout sessions, plenary sessions, and a poster session including 100 abstracts. Among the 358 attendees were clinical investigators, researchers of accrual strategies, research administrators, nurses, research coordinators, patient advocates, and educators. A bibliography of the accrual literature in these three major areas was provided to participants in advance of the meeting. After the symposium, the literature in these areas was revisited to determine if the symposium recommendations remained relevant within the context of the current literature. Results: Few rigorously conducted studies have tested interventions to address challenges to clinical trials accrual. Attendees developed recommendations for improving accrual and identified priority areas for future accrual research at the patient/community, physician/provider, and site/organizational levels. Current literature continues to support the symposium recommendations. Conclusions: A combination of approaches addressing both the multifactorial nature of accrual challenges and the characteristics of the target population may be needed to improve accrual to cancer clinical trials. Recommendations for best practices and for future research developed from the symposium are provided. PMID:24130252

  20. [Quality assessment program of the Spanish Society of Infectious Diseases and Clinical Microbiology. Analysis of results. 2005].

    PubMed

    Orta Mira, Nieves; Guna Serrano, M del Remedio; Pérez, José L; Gimeno Cardona, Concepción

    2006-10-01

    Quality assurance of the analytical processes performed at the clinical microbiology laboratory is mandatory and should be carried out by using external and internal quality control activities. External quality assessment programs allow intercomparison within laboratories, detection of errors, and evaluation of the suitability of some reagents or diagnostic kits for the purpose for which they were designed; these activities are also useful for continuous education. The program launched 15 years ago by the Spanish Society of Infectious Diseases and Clinical Microbiology is based on sending typified materials along with a clinical and microbiological case related to these control materials. The spectrum of the samples is broad, including bacteriology (monthly and three-monthly), serology, mycology, parasitology, mycobacteria, virology, and molecular microbiology. After receiving the results from the participants, the program organization delivers an individual certificate comparing the results with those of a reference laboratory. Additionally, a report is generated by analyzing all the results sent by the participants; laboratories are also sent review articles on the subject of each assessment as a tool for continuous education in clinical microbiology. In this article, the most relevant conclusions and lessons from the 2005 assessments are presented.

  1. Prevention and Monitoring of Cardiac Dysfunction in Survivors of Adult Cancers: American Society of Clinical Oncology Clinical Practice Guideline.

    PubMed

    Armenian, Saro H; Lacchetti, Christina; Barac, Ana; Carver, Joseph; Constine, Louis S; Denduluri, Neelima; Dent, Susan; Douglas, Pamela S; Durand, Jean-Bernard; Ewer, Michael; Fabian, Carol; Hudson, Melissa; Jessup, Mariell; Jones, Lee W; Ky, Bonnie; Mayer, Erica L; Moslehi, Javid; Oeffinger, Kevin; Ray, Katharine; Ruddy, Kathryn; Lenihan, Daniel

    2016-12-05

    Purpose Cardiac dysfunction is a serious adverse effect of certain cancer-directed therapies that can interfere with the efficacy of treatment, decrease quality of life, or impact the actual survival of the patient with cancer. The purpose of this effort was to develop recommendations for prevention and monitoring of cardiac dysfunction in survivors of adult-onset cancers. Methods Recommendations were developed by an expert panel with multidisciplinary representation using a systematic review (1996 to 2016) of meta-analyses, randomized clinical trials, observational studies, and clinical experience. Study quality was assessed using established methods, per study design. The guideline recommendations were crafted in part using the Guidelines Into Decision Support methodology. Results A total of 104 studies met eligibility criteria and compose the evidentiary basis for the recommendations. The strength of the recommendations in these guidelines is based on the quality, amount, and consistency of the evidence and the balance between benefits and harms. Recommendations It is important for health care providers to initiate the discussion regarding the potential for cardiac dysfunction in individuals in whom the risk is sufficiently high before beginning therapy. Certain higher risk populations of survivors of cancer may benefit from prevention and screening strategies implemented during cancer-directed therapies. Clinical suspicion for cardiac disease should be high and threshold for cardiac evaluation should be low in any survivor who has received potentially cardiotoxic therapy. For certain higher risk survivors of cancer, routine surveillance with cardiac imaging may be warranted after completion of cancer-directed therapy, so that appropriate interventions can be initiated to halt or even reverse the progression of cardiac dysfunction.

  2. Recommendations on disease management for patients with advanced human epidermal growth factor receptor 2-positive breast cancer and brain metastases: American Society of Clinical Oncology clinical practice guideline.

    PubMed

    Ramakrishna, Naren; Temin, Sarah; Chandarlapaty, Sarat; Crews, Jennie R; Davidson, Nancy E; Esteva, Francisco J; Giordano, Sharon H; Gonzalez-Angulo, Ana M; Kirshner, Jeffrey J; Krop, Ian; Levinson, Jennifer; Modi, Shanu; Patt, Debra A; Perez, Edith A; Perlmutter, Jane; Winer, Eric P; Lin, Nancy U

    2014-07-01

    To provide formal expert consensus-based recommendations to practicing oncologists and others on the management of brain metastases for patients with human epidermal growth factor receptor 2 (HER2) -positive advanced breast cancer. The American Society of Clinical Oncology (ASCO) convened a panel of medical oncology, radiation oncology, guideline implementation, and advocacy experts and conducted a systematic review of the literature. When that failed to yield sufficiently strong quality evidence, the Expert Panel undertook a formal expert consensus-based process to produce these recommendations. ASCO used a modified Delphi process. The panel members drafted recommendations, and a group of other experts joined them for two rounds of formal ratings of the recommendations. No studies or existing guidelines met the systematic review criteria; therefore, ASCO conducted a formal expert consensus-based process. Patients with brain metastases should receive appropriate local therapy and systemic therapy, if indicated. Local therapies include surgery, whole-brain radiotherapy, and stereotactic radiosurgery. Treatments depend on factors such as patient prognosis, presence of symptoms, resectability, number and size of metastases, prior therapy, and whether metastases are diffuse. Other options include systemic therapy, best supportive care, enrollment onto a clinical trial, and/or palliative care. Clinicians should not perform routine magnetic resonance imaging (MRI) to screen for brain metastases, but rather should have a low threshold for MRI of the brain because of the high incidence of brain metastases among patients with HER2-positive advanced breast cancer. © 2014 by American Society of Clinical Oncology.

  3. Brief of the Canadian Society for Clinical Investigation to the science and technology review.

    PubMed

    1995-02-01

    In the context of new realities, perceptions, and concerns, it is fitting that the government has undertaken this Science and Technology Review, questioning not only how much to spend but also the justification and the best ways to carry out federally-funded research. We share the government's concern about the lack of economic competitiveness of our industries and agree that government-sponsored research should make a bigger contribution to the nation's global economic position. The CSCI, which represents the clinical investigators/scientists in this country, is grateful for having been given the opportunity to make this "tour d'horizon" of Canadian clinical research. In this brief, we have attempted to articulate the needs for, and the benefits of, basic biomedical research because it is the only type of research which will provide us with final answers. However, it should be more closely articulated with applied research, as well as with epidemiological, evaluative, and operational approaches which have been neglected. This brief has emphasized that CSCI is committed to PUTTING MORE SCIENCE INTO MEDICINE by encouraging a greater flow of discoveries from the laboratory research bench to the bedside and the community. We made the point that there is a crisis in patient-oriented research and a decrease of young physicians opting for research careers. The Royal College of Physicians and Surgeons of Canada and the MRC are responsive to this situation, which may compromise our capacity to discharge our broader mission. The MRC has given itself valid instruments to foster the creation of wealth through special programs such as the NCE, the University/Industry program, and the MRC-PMAC partnership. Some refining is in order, and close scrutiny of outcome is essential. Both the academic community and industry have their share of responsibility for the less-than-optimal transfer of knowledge to the market place. Lack of venture capital is also a serious issue. A unified

  4. Untapped Potential of Observational Research to Inform Clinical Decision Making: American Society of Clinical Oncology Research Statement.

    PubMed

    Visvanathan, Kala; Levit, Laura A; Raghavan, Derek; Hudis, Clifford A; Wong, Sandra; Dueck, Amylou; Lyman, Gary H

    2017-06-01

    ASCO believes that high-quality observational studies can advance evidence-based practice for cancer care and are complementary to randomized controlled trials (RCTs). Observational studies can generate hypotheses by evaluating novel exposures or biomarkers and by revealing patterns of care and relationships that might not otherwise be discovered. Researchers can then test these hypotheses in RCTs. Observational studies can also answer or inform questions that either have not been or cannot be answered by RCTs. In addition, observational studies can be used for postmarketing surveillance of new cancer treatments, particularly in vulnerable populations. The incorporation of observational research as part of clinical decision making is consistent with the position of many leading institutions. ASCO identified five overarching recommendations to enhance the role of observational research in clinical decision making: (1) improve the quality of electronic health data available for research, (2) improve interoperability and the exchange of electronic health information, (3) ensure the use of rigorous observational research methodologies, (4) promote transparent reporting of observational research studies, and (5) protect patient privacy.

  5. Germ line genome editing in clinics: the approaches, objectives and global society.

    PubMed

    Ishii, Tetsuya

    2017-01-01

    Genome editing allows for the versatile genetic modification of somatic cells, germ cells and embryos. In particular, CRISPR/Cas9 is worldwide used in biomedical research. Although the first report on Cas9-mediated gene modification in human embryos focused on the prevention of a genetic disease in offspring, it raised profound ethical and social concerns over the safety of subsequent generations and the potential misuse of genome editing for human enhancement. The present article considers germ line genome editing approaches from various clinical and ethical viewpoints and explores its objectives. The risks and benefits of the following three likely objectives are assessed: the prevention of monogenic diseases, personalized assisted reproductive technology (ART) and genetic enhancement. Although genetic enhancement should be avoided, the international regulatory landscape suggests the inevitability of this misuse at ART centers. Under these circumstances, possible regulatory responses and the potential roles of public dialogue are discussed.

  6. Germ line genome editing in clinics: the approaches, objectives and global society

    PubMed Central

    2017-01-01

    Genome editing allows for the versatile genetic modification of somatic cells, germ cells and embryos. In particular, CRISPR/Cas9 is worldwide used in biomedical research. Although the first report on Cas9-mediated gene modification in human embryos focused on the prevention of a genetic disease in offspring, it raised profound ethical and social concerns over the safety of subsequent generations and the potential misuse of genome editing for human enhancement. The present article considers germ line genome editing approaches from various clinical and ethical viewpoints and explores its objectives. The risks and benefits of the following three likely objectives are assessed: the prevention of monogenic diseases, personalized assisted reproductive technology (ART) and genetic enhancement. Although genetic enhancement should be avoided, the international regulatory landscape suggests the inevitability of this misuse at ART centers. Under these circumstances, possible regulatory responses and the potential roles of public dialogue are discussed. PMID:26615180

  7. Clinical Cancer Advances 2017: Annual Report on Progress Against Cancer From the American Society of Clinical Oncology.

    PubMed

    Burstein, Harold J; Krilov, Lada; Aragon-Ching, Jeanny B; Baxter, Nancy N; Chiorean, E Gabriela; Chow, Warren Allen; De Groot, John Frederick; Devine, Steven Michael; DuBois, Steven G; El-Deiry, Wafik S; Epstein, Andrew S; Heymach, John; Jones, Joshua Adam; Mayer, Deborah K; Miksad, Rebecca A; Pennell, Nathan A; Sabel, Michael S; Schilsky, Richard L; Schuchter, Lynn Mara; Tung, Nadine; Winkfield, Karen Marie; Wirth, Lori J; Dizon, Don S

    2017-02-01

    A MESSAGE FROM ASCO'S PRESIDENT I am pleased to present Clinical Cancer Advances 2017, which highlights the most promising advances in patient-oriented cancer research over the past year. The report gives us an opportunity to reflect on what an exciting time it is for cancer research and how swiftly our understanding of cancer has improved. One year ago, the White House announced the national Cancer Moonshot program to accelerate progress against cancer. This shared vision of progress has reinvigorated the research community, identified new areas of scientific collaboration, and raised our ambitions regarding what may be possible beyond the progress we have already made. When I entered the field 35 years ago, I could not have imagined where we would be today. We can now detect cancer earlier, target treatments more effectively, and manage adverse effects more effectively to enable patients to live better, more fulfilling lives. Today, two of three people with cancer live at least 5 years after diagnosis, up from roughly one of two in the 1970s. This progress has resulted from decades of incremental advances that have collectively expanded our understanding of the molecular underpinnings of cancer. There is no better current example of this than ASCO's 2017 Advance of the Year: Immunotherapy 2.0. Over the last year, there has been a wave of new successes with immunotherapy. Research has proven this approach can be effective against a wide range of hard-to-treat advanced cancers previously considered intractable. Researchers are now working to identify biologic markers that can help increase the effectiveness of treatment and determine who is most likely to benefit from immunotherapy. This knowledge will enable oncologists to make evidence-based decisions so as many patients as possible might benefit from this new type of treatment. Each successive advance builds on the previous hard work of generations of basic, translational, and clinical cancer researchers

  8. Outcomes of longitudinal integrated clinical placements for students, clinicians and society.

    PubMed

    Walters, Lucie; Greenhill, Jennene; Richards, Janet; Ward, Helena; Campbell, Narelle; Ash, Julie; Schuwirth, Lambert W T

    2012-11-01

    Longitudinal integrated clerkships (LICs) have been widely implemented in both rural and urban contexts, as is now evident in the wealth of studies published internationally. This narrative literature review aims to summarise current evidence regarding the outcomes of LICs for student, clinician and community stakeholders. Recent literature was examined for original research articles pertaining to outcomes of LICs. Students in LICs achieve academic results equivalent to and in some cases better than those of their counterparts who receive clinical education in block rotations. Students in LICs are reported to have well-developed patient-centred communication skills, demonstrate understanding of the psychosocial contributions to medicine, and report more preparedness in higher-order clinical and cognitive skills in comparison with students in traditional block rotations (TBRs). Students in LICs take on increased responsibility with patients and describe having more confidence in dealing with ethical dilemmas. Continuity of supervision reportedly facilitates incremental knowledge acquisition, and supervisors provide incrementally progressive feedback. Despite early disorientation regarding the organising of their learning, students feel well supported by the continuity of student-preceptor relationships and value the contributions made by these. Students in LICs living and working in rural areas are positively influenced towards primary care and rural career choices. A sound body of knowledge in the field of LIC research suggests it is time to move beyond descriptive or exploratory research that is designed to justify this new educational approach by comparing academic results. As the attributes of LIC alumni are better understood, it is important to conduct explanatory research to develop a more complete understanding of these findings and a foundation for new theoretical frameworks that underpin educational change. Longitudinal integrated clerkships are now

  9. Clinical validity of Fuld Object Memory Evaluation to screen for dementia in a Chinese society.

    PubMed

    Chung, Jenny C C

    2009-02-01

    Fuld Object Memory Evaluation (FOME) evaluates the episodic memory functions of encoding, storage, and recall across five recall trials and a delayed recall trial. This study examined the clinical validity of FOME as a screening tool for dementia in older Chinese adults. The psychometric properties and the discriminative power of FOME were examined in a convenience sample of 192 community-dwelling older individuals, of which 57 were diagnosed with dementia. The influence of age and education on the FOME performance was also estimated. The test-retest reliability and parallel-form reliability of FOME were excellent, with Intraclass Correlation Coefficients ranging from 0.91-0.96. Good convergent validity of FOME was established with Mini-Mental State Examination (r(p) = 0.69-0.74), and the Memory subscale and the Initiation/Perseveration subscale of Dementia Rating Scale (r(p) = 0.63-0.74). The FOME total retrieval (TR) score and delayed recall (DR) score demonstrated good discriminative power in differentiating dementia from normal cognitive functioning, with area under the curve values of 0.97 and 0.93 respectively. The optimal cut-off scores suggested for TR and DR were 31 (93% sensitivity, 90 specificity) and 7 (91% sensitivity, 82% specificity), respectively. The performance of the FOME was not influenced by the educational level. The results suggest that the FOME is a reliable and valid instrument to screen for dementia in older community-dwelling Chinese adults. The absence of the effects of education on the assessment performance makes FOME a clinically useful instrument for older adults with limited education. (c) 2008 John Wiley & Sons, Ltd.

  10. The future of hospital laboratories. Position statement from the Royal Belgian Society of Clinical Chemistry (RBSCC).

    PubMed

    Langlois, Michel R; Wallemacq, Pierre

    2009-01-01

    To face the economic pressures arising from the current socio-economic conjuncture, hospital laboratories are endangered by an increasing trend towards the outsourcing of clinical laboratory tests to external (mega-) laboratories. This should allow hospitals to meet their economic requirements, but with an increased risk of loss of medical quality and, mid- to long-term, loss of cost effectiveness of healthcare at the national level. To anticipate current developments (economical and technological) that inevitably will affect the future of laboratory medicine, hospital laboratories should be proactive and enhance efficiency, reduce costs by consolidation, integrate into regional networks, and form alliances or partnerships. To create additional value, the core competency of laboratory professionals must be refocused to provide medical knowledge services (consultative support to clinicians) related to in vitro diagnostic testing. To integrate cost-efficiency with medical quality, implementation of a matricial organization - operational vs. biomedical level - could be an interesting approach. This integrated structure should create total quality of laboratory testing, managing the entire medical diagnostic cycle from the pre-preanalytical to post-postanalytical phase.

  11. An official American Thoracic Society clinical practice guideline: exercise-induced bronchoconstriction.

    PubMed

    Parsons, Jonathan P; Hallstrand, Teal S; Mastronarde, John G; Kaminsky, David A; Rundell, Kenneth W; Hull, James H; Storms, William W; Weiler, John M; Cheek, Fern M; Wilson, Kevin C; Anderson, Sandra D

    2013-05-01

    Exercise-induced bronchoconstriction (EIB) describes acute airway narrowing that occurs as a result of exercise. EIB occurs in a substantial proportion of patients with asthma, but may also occur in individuals without known asthma. To provide clinicians with practical guidance, a multidisciplinary panel of stakeholders was convened to review the pathogenesis of EIB and to develop evidence-based guidelines for the diagnosis and treatment of EIB. The evidence was appraised and recommendations were formulated using the Grading of Recommendations, Assessment, Development, and Evaluation approach. Recommendations for the treatment of EIB were developed. The quality of evidence supporting the recommendations was variable, ranging from low to high. A strong recommendation was made for using a short-acting β(2)-agonist before exercise in all patients with EIB. For patients who continue to have symptoms of EIB despite the administration of a short-acting β(2)-agonist before exercise, strong recommendations were made for a daily inhaled corticosteroid, a daily leukotriene receptor antagonist, or a mast cell stabilizing agent before exercise. The recommendations in this Guideline reflect the currently available evidence. New clinical research data will necessitate a revision and update in the future.

  12. [Sublingual immunotherapy in children. Immunotherapy Committee of the Spanish Society for Clinical Immunology and Pediatric Allergology].

    PubMed

    Lleonart, R; Muñoz, F; Eseverri, J L; Martínez-Cañabate, A; Tabar, A I; Pedemonte, C

    2003-01-01

    Sublingual immunotherapy is currently attracting growing interest because of its ease of administration and, according to previous studies, its infrequent and mild adverse effects. However, at least in children, the efficacy of this therapy has not been completely demonstrated. In addition, the mechanisms of action remain to be elucidated since few studies have been published and the results have been contradictory and sometimes inconclusive. For this reason, we performed a literature review through the MEDLINE database, selecting double-blind studies carried out in children. Only 10 studies meeting these requirements were retrieved. All the studies were performed by European researchers and nine were published in European journals. Efficacy was evaluated by clinical parameters and by reduction in medication use. The results on efficacy are not homogeneous, although most support the utility of this route of administration. Moreover, reports of allergens other than those used in these studies dust mites and grass pollens are lacking. In conclusion, further studies evaluating the efficacy of this therapy in children are required. Among the general population, if the efficacy of sublingual immunotherapy in the treatment of sensitization to hymenoptera venoms were demonstrated, as has been the case with subcutaneous immunotherapy, the utility of this route of administration would be definitively confirmed. Finally, sublingual immunotherapy could be used in children who have shown systemic reactions to subcutaneous immunotherapy or who refuse to undergo injections.

  13. Patient-Clinician Communication: American Society of Clinical Oncology Consensus Guideline.

    PubMed

    Gilligan, Timothy; Coyle, Nessa; Frankel, Richard M; Berry, Donna L; Bohlke, Kari; Epstein, Ronald M; Finlay, Esme; Jackson, Vicki A; Lathan, Christopher S; Loprinzi, Charles L; Nguyen, Lynne H; Seigel, Carole; Baile, Walter F

    2017-09-11

    Purpose To provide guidance to oncology clinicians on how to use effective communication to optimize the patient-clinician relationship, patient and clinician well-being, and family well-being. Methods ASCO convened a multidisciplinary panel of medical oncology, psychiatry, nursing, hospice and palliative medicine, communication skills, health disparities, and advocacy experts to produce recommendations. Guideline development involved a systematic review of the literature and a formal consensus process. The systematic review focused on guidelines, systematic reviews and meta-analyses, and randomized controlled trials published from 2006 through October 1, 2016. Results The systematic review included 47 publications. With the exception of clinician training in communication skills, evidence for many of the clinical questions was limited. Draft recommendations underwent two rounds of consensus voting before being finalized. Recommendations In addition to providing guidance regarding core communication skills and tasks that apply across the continuum of cancer care, recommendations address specific topics, such as discussion of goals of care and prognosis, treatment selection, end-of-life care, facilitating family involvement in care, and clinician training in communication skills. Recommendations are accompanied by suggested strategies for implementation. Additional information is available at www.asco.org/supportive-care-guidelines and www.asco.org/guidelineswiki .

  14. The Infectious Diseases Society of America Lyme guidelines: a cautionary tale about the development of clinical practice guidelines

    PubMed Central

    2010-01-01

    Flawed clinical practice guidelines may compromise patient care. Commercial conflicts of interest on panels that write treatment guidelines are particularly problematic, because panelists may have conflicting agendas that influence guideline recommendations. Historically, there has been no legal remedy for conflicts of interest on guidelines panels. However, in May 2008, the Attorney General of Connecticut concluded a ground-breaking antitrust investigation into the development of Lyme disease treatment guidelines by one of the largest medical societies in the United States, the Infectious Diseases Society of America (IDSA). Although the investigation found significant flaws in the IDSA guidelines development process, the subsequent review of the guidelines mandated by the settlement was compromised by a lack of impartiality at various stages of the IDSA review process. This article will examine the interplay between the recent calls for guidelines reform, the ethical canons of medicine, and due process considerations under antitrust laws as they apply to the formulation of the IDSA Lyme disease treatment guidelines. The article will also discuss pitfalls in the implementation of the IDSA antitrust settlement that should be avoided in the future. PMID:20529367

  15. The Infectious Diseases Society of America Lyme guidelines: a cautionary tale about the development of clinical practice guidelines.

    PubMed

    Johnson, Lorraine; Stricker, Raphael B

    2010-06-09

    Flawed clinical practice guidelines may compromise patient care. Commercial conflicts of interest on panels that write treatment guidelines are particularly problematic, because panelists may have conflicting agendas that influence guideline recommendations. Historically, there has been no legal remedy for conflicts of interest on guidelines panels. However, in May 2008, the Attorney General of Connecticut concluded a ground-breaking antitrust investigation into the development of Lyme disease treatment guidelines by one of the largest medical societies in the United States, the Infectious Diseases Society of America (IDSA). Although the investigation found significant flaws in the IDSA guidelines development process, the subsequent review of the guidelines mandated by the settlement was compromised by a lack of impartiality at various stages of the IDSA review process. This article will examine the interplay between the recent calls for guidelines reform, the ethical canons of medicine, and due process considerations under antitrust laws as they apply to the formulation of the IDSA Lyme disease treatment guidelines. The article will also discuss pitfalls in the implementation of the IDSA antitrust settlement that should be avoided in the future.

  16. The Lebanese Society for Infectious Diseases and Clinical Microbiology (LSIDCM) guidelines for adult community-acquired pneumonia (Cap) in Lebanon.

    PubMed

    Moghnieh, Rima; Yared Sakr, Nadine; Kanj, Souha S; Musharrafieh, Umayya; Husni, Rula; Jradeh, Mona; Al-Awar, Ghassan; Matar, Madona; Jureij, Wafa; Antoine, Saad; Azar, Eid; Abi Hanna, Pierre; Minari, Afaf; Hammoud, Jamale; Kfoury, Joumana; Mahfouz, Tahsin; Abou Chakra, Diaa; Zaatari, Mohamad; Tabbarah, Zuhayr A

    2014-01-01

    Adult community-acquired pneumonia (CAP) is a common cause of morbidity and mortality which is managed by different disciplines in a heterogeneous fashion. Development of consensus guidelines to standardize these wide variations in care has become a prime objective. The Lebanese Society of Infectious Diseases and Clinical Microbiology (LSIDCM) convened to set Lebanese national guidelines for the management of CAP since it is a major and a prevalent disease affecting the Lebanese population. These guidelines, besides being helpful in direct clinical practice, play a major role in establishing stewardship programs in hospitals in an effort to contain antimicrobial resistance on the national level. These guidelines are intended for primary care practitioners and emergency medicine physicians. They constitute an appropriate starting point for specialists' consultation being based on the available local epidemiological and resistance data. This document includes the following: 1/ Rationale and scope of the guidelines; 2/ Microbiology of CAP based on Lebanese data; 3/ Clinical presentation and diagnostic workup of CAP; 4/ Management and prevention strategies based on the IDSA/ATS Consensus Guidelines, 2007, and the ESCMID Guidelines, 2011, and tailored to the microbiological data in Lebanon; 5/ Comparison to regional guidelines. The recommendations made in this document were graded based on the strength of the evidence as in the 2007 IDSA/ATS Consensus Guidelines. Hopefully, these guidelines will be an important step towards standardization of CAP care in Lebanon and set the agenda for further research in this area.

  17. Report on the International Society for Laboratory Hematology Survey on guidelines to support clinical hematology laboratory practice.

    PubMed

    Hayward, C P M; Moffat, K A; George, T I; Proytcheva, M; Iorio, A

    2016-05-01

    Given the importance of evidence-based guidelines in health care, we surveyed the laboratory hematology community to determine their opinions on guideline development and their experience and interest in developing clinical hematology laboratory practice guidelines. The study was conducted using an online survey, distributed to members of the International Society for Laboratory Hematology (ISLH) in 2015, with analysis of collected, anonymized responses. A total of 245 individuals participated. Most worked in clinical and/or research laboratories (83%) or industry (11%). 42% felt there were gaps in current guidelines. The majority (58%) recommended that ISLH engages its membership in guideline development. Participants differed in their familiarity with, and use of, different organizations' guidelines. Participants felt it was important to follow best practice recommendations on guideline development, including engagement of experts, statement about conflict of interests and how they were managed, systematic review and grading evidence for recommendations, identifying recommendations lacking evidence or consensus, and public input and peer review of the guideline. Moreover, it was considered important to provide guidelines free of charge. Industry involvement in guidelines was considered less important. The clinical laboratory hematology community has high expectations of laboratory practice guidelines that are consistent with recent recommendations on evidence-based guideline development. © 2016 John Wiley & Sons Ltd.

  18. Reliability and validity of the subjective component of the American Orthopaedic Foot and Ankle Society clinical rating scales.

    PubMed

    Ibrahim, Talal; Beiri, Almoghera; Azzabi, Mohamed; Best, Alistair J; Taylor, Grahame J; Menon, Dipen K

    2007-01-01

    This study evaluates the criterion validity of the subjective component of the American Orthopaedic Foot and Ankle Society (AOFAS) clinical rating scales by correlating scores obtained with these rating scales to scores obtained with the Foot Function Index (FFI) in patients with foot and ankle conditions. To date, the AOFAS scoring scales have not been shown to provide valid information despite their popularity. The FFI, on the other hand, has previously been shown to provide valid information in regard to conditions affecting the foot and ankle. A moderately strong inverse criterion validity correlation (Pearson correlation coefficient = -0.68) was shown when preoperative patients were administered both the AOFAS and FFI questionnaires, and the resultant scores were compared. Test-retest reliability measurements showed no significant difference (P = .27) between preoperative AOFAS scale scores measured at least 2 weeks apart. Construct validity was shown (P = .006) when dependent preoperative and postoperative (at least 3 months) AOFAS scale scores were compared, indicative of the clinical rating scales' ability to discriminate and predict quality of life related to foot and ankle conditions. The moderate level of correlation, satisfactory degree of reliability, and responsiveness (ability to distinguish differences between preoperative and postoperative conditions in the same patient) observed in this study suggest that the subjective component of the AOFAS clinical rating scales provides quality-of-life information that conveys acceptable validity regarding conditions affecting the foot and ankle.

  19. Time, Clinic Technologies, and the Making of Reflexive Longevity: The cultural work of 'time left' in an aging society.

    PubMed

    Kaufman, Sharon R

    2010-02-01

    Developments in clinical intervention are having a profound impact on health and health behaviors in late life and on ideas about longevity and the appropriate time for death. The fact that the timing of death is even considered to be a controllable event is a relatively new cultural phenomenon. The activities that make up life extension, like other medical practices scrutinized by social scientists, constitute a site for the emergence of new forms of subjectivity. For older adults the clinical encounter forces a calculation about how much 'time left' is wanted in relation to age. The twin dimensions of the transformation of time highlighted in this essay -- the control over the timing of death and the creation of 'time left' -- both contribute to and are a widespread effect of biomedicalization in affluent sectors of society. Through three stories this essay begins to map the cultural work that the concept, 'time left,' does, the socio-medical ways in which that notion is talked about, organized and calculated in the American clinic today. It asks, what kind of subject emerges when longevity, imbued with the technological, becomes a reflexive practice and an object of intervention and apparent choice?

  20. Time, clinic technologies, and the making of reflexive longevity: the cultural work of time left in an ageing society.

    PubMed

    Kaufman, Sharon R

    2010-02-01

    Developments in clinical intervention are having a profound impact on health and health behaviours in late life and on ideas about longevity and the appropriate time for death. The fact that the timing of death is even considered to be a controllable event is a relatively new cultural phenomenon. The activities that make up life extension, like other medical practices scrutinised by social scientists, constitute a site for the emergence of new forms of subjectivity. For older adults the clinical encounter forces a calculation about how much time left is wanted in relation to age. The twin dimensions of the transformation of time highlighted in this article - the control over the timing of death and the creation of time left - both contribute to and are a widespread effect of biomedicalisation in affluent sectors of society. Through three stories this paper begins to map the cultural work that the concept, time left, does, the socio-medical ways in which that notion is talked about, organised and calculated in the American clinic today. It asks, what kind of subject emerges when longevity, imbued with the technological, becomes a reflexive practice and an object of intervention and apparent choice?

  1. European Society of Clinical Microbiology and Infectious Diseases: update of the treatment guidance document for Clostridium difficile infection.

    PubMed

    Debast, S B; Bauer, M P; Kuijper, E J

    2014-03-01

    In 2009 the first European Society of Clinical Microbiology and Infection (ESCMID) treatment guidance document for Clostridium difficile infection (CDI) was published. The guideline has been applied widely in clinical practice. In this document an update and review on the comparative effectiveness of the currently available treatment modalities of CDI is given, thereby providing evidence-based recommendations on this issue. A computerized literature search was carried out to investigate randomized and non-randomized trials investigating the effect of an intervention on the clinical outcome of CDI. The Grades of Recommendation Assessment, Development and Evaluation (GRADE) system was used to grade the strength of our recommendations and the quality of the evidence. The ESCMID and an international team of experts from 11 European countries supported the process. To improve clinical guidance in the treatment of CDI, recommendations are specified for various patient groups, e.g. initial non-severe disease, severe CDI, first recurrence or risk for recurrent disease, multiple recurrences and treatment of CDI when oral administration is not possible. Treatment options that are reviewed include: antibiotics, toxin-binding resins and polymers, immunotherapy, probiotics, and faecal or bacterial intestinal transplantation. Except for very mild CDI that is clearly induced by antibiotic usage antibiotic treatment is advised. The main antibiotics that are recommended are metronidazole, vancomycin and fidaxomicin. Faecal transplantation is strongly recommended for multiple recurrent CDI. In case of perforation of the colon and/or systemic inflammation and deteriorating clinical condition despite antibiotic therapy, total abdominal colectomy or diverting loop ileostomy combined with colonic lavage is recommended.

  2. [Spanish Society of Clinical Microbiology and Infectious Diseases (SEIMC) guidelines for the diagnosis of invasive fungal infections. 2010 update].

    PubMed

    Ayats, Josefina; Martín-Mazuelos, Estrella; Pemán, Javier; Quindós, Guillermo; Sánchez, Fernando; García-Rodríguez, Julio; Guarro, Josep; Guinea, Jesús; Linares, María J; Pontón, José; Rodríguez-Tudela, Juan L; Cuenca-Estrella, Manuel

    2011-01-01

    These guidelines are an update of recommendations for the diagnosis of invasive fungal infections by the Spanish Society of Clinical Microbiology and Infectious Diseases (SEIMC) published in 2004 (Enferm Infecc Microbiol Clin. 2004, 22:32-9). In this updated version of the guidelines, a comprehensive review of the most recent diagnostic innovations and levels of evidence to recommend those diagnostic procedures are included. We first analyse conventional diagnostic methods, microscopic examination and culture, underlining their limitations which have led to the development of alternative methods, such as fungal antigen and DNA quantification. Those alternative methods of diagnosis are analysed by fungal infection. We also briefly review the methods for molecular identification of fungal species and recommendations for carrying out susceptibility tests for antifungal drugs, including reference procedures, commercial techniques and their indications.

  3. American Society of Clinical Oncology Strategic Plan for Increasing Racial and Ethnic Diversity in the Oncology Workforce.

    PubMed

    Winkfield, Karen M; Flowers, Christopher R; Patel, Jyoti D; Rodriguez, Gladys; Robinson, Patricia; Agarwal, Amit; Pierce, Lori; Brawley, Otis W; Mitchell, Edith P; Head-Smith, Kimberly T; Wollins, Dana S; Hayes, Daniel F

    2017-08-01

    In December 2016, the American Society of Clinical Oncology (ASCO) Board of Directors approved the ASCO Strategic Plan to Increase Racial and Ethnic Diversity in the Oncology Workforce. Developed through a multistakeholder effort led by the ASCO Health Disparities Committee, the purpose of the plan is to guide the formal efforts of ASCO in this area over the next three years (2017 to 2020). There are three primary goals: (1) to establish a longitudinal pathway for increasing workforce diversity, (2) to enhance ASCO leadership diversity, and (3) to integrate a focus on diversity across ASCO programs and policies. Improving quality cancer care in the United States requires the recruitment of oncology professionals from diverse backgrounds. The ASCO Strategic Plan to Increase Racial and Ethnic Diversity in the Oncology Workforce is designed to enhance existing programs and create new opportunities that will move us closer to the vision of achieving an oncology workforce that reflects the demographics of the US population it serves.

  4. Quantitative PET/CT scanner performance characterization based upon the society of nuclear medicine and molecular imaging clinical trials network oncology clinical simulator phantom.

    PubMed

    Sunderland, John J; Christian, Paul E

    2015-01-01

    The Clinical Trials Network (CTN) of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) operates a PET/CT phantom imaging program using the CTN's oncology clinical simulator phantom, designed to validate scanners at sites that wish to participate in oncology clinical trials. Since its inception in 2008, the CTN has collected 406 well-characterized phantom datasets from 237 scanners at 170 imaging sites covering the spectrum of commercially available PET/CT systems. The combined and collated phantom data describe a global profile of quantitative performance and variability of PET/CT data used in both clinical practice and clinical trials. Individual sites filled and imaged the CTN oncology PET phantom according to detailed instructions. Standard clinical reconstructions were requested and submitted. The phantom itself contains uniform regions suitable for scanner calibration assessment, lung fields, and 6 hot spheric lesions with diameters ranging from 7 to 20 mm at a 4:1 contrast ratio with primary background. The CTN Phantom Imaging Core evaluated the quality of the phantom fill and imaging and measured background standardized uptake values to assess scanner calibration and maximum standardized uptake values of all 6 lesions to review quantitative performance. Scanner make-and-model-specific measurements were pooled and then subdivided by reconstruction to create scanner-specific quantitative profiles. Different makes and models of scanners predictably demonstrated different quantitative performance profiles including, in some cases, small calibration bias. Differences in site-specific reconstruction parameters increased the quantitative variability among similar scanners, with postreconstruction smoothing filters being the most influential parameter. Quantitative assessment of this intrascanner variability over this large collection of phantom data gives, for the first time, estimates of reconstruction variance introduced into trials from allowing

  5. Canadian Society of Nephrology commentary on the KDIGO clinical practice guideline for CKD evaluation and management.

    PubMed

    Akbari, Ayub; Clase, Catherine M; Acott, Phil; Battistella, Marisa; Bello, Aminu; Feltmate, Patrick; Grill, Allan; Karsanji, Meena; Komenda, Paul; Madore, Francois; Manns, Braden J; Mahdavi, Sara; Mustafa, Reem A; Smyth, Andrew; Welcher, E Sohani

    2015-02-01

    We congratulate the KDIGO (Kidney Disease: Improving Global Outcomes) work group on their comprehensive work in a broad subject area and agreed with many of the recommendations in their clinical practice guideline on the evaluation and management of chronic kidney disease. We concur with the KDIGO definitions and classification of kidney disease and welcome the addition of albuminuria categories at all levels of glomerular filtration rate (GFR), the terminology of G categories rather than stages to describe level of GFR, the division of former stage 3 into new G categories 3a and 3b, and the addition of the underlying diagnosis. We agree with the use of the heat map to illustrate the relative contributions of low GFR and albuminuria to cardiovascular and renal risk, though we thought that the highest risk category was too broad, including as it does people at disparate levels of risk. We add an albuminuria category A4 for nephrotic-range proteinuria and D and T categories for patients on dialysis or with a functioning renal transplant. We recommend target blood pressure of 140/90mm Hg regardless of diabetes or proteinuria, and against the combination of angiotensin receptor blockers with angiotensin-converting enzyme inhibitors. We recommend against routine protein restriction. We concur on individualization of hemoglobin A1c targets. We do not agree with routine restriction of sodium intake to <2g/d, instead suggesting reduction of sodium intake in those with high intake (>3.3g/d). We suggest screening for anemia only when GFR is <30mL/min/1.73m(2). We recognize the absence of evidence on appropriate phosphate targets and methods of achieving them and do not agree with suggestions in this area. In drug dosing, we agree with the recommendation of using absolute clearance (ie, milliliters per minute), calculated from the patient's estimated GFR (which is normalized to 1.73m(2)) and the patient's actual anthropomorphic body surface area. We agree with referral to a

  6. Isolation of Tritrichomonas foetus from cats sampled at a cat clinic, cat shows and a humane society in southern Ontario.

    PubMed

    Hosein, Ansarah; Kruth, Stephen A; Pearl, David L; Richardson, Danielle; Maggs, Jocelyn C; Peach, Hillary A; Peregrine, Andrew S

    2013-08-01

    Tritrichomonas foetus is a protozoan parasite that has been associated with chronic diarrhea in cats. This study aimed to determine (i) the prevalence of T foetus shedding in cats from three different populations in southern Ontario, and (ii) associations between the presence of T foetus and potential cat management, health and demographic risk factors. A cross-sectional study was conducted involving 140 cats from a cat clinic in Guelph, 46 cats from a humane society in Guelph and 55 cats from two cat shows. Risk factor information was assessed through a questionnaire. The InPouch TF (feline) culture method was used to determine the presence of T foetus in all samples. Polymerase chain reaction was conducted on all samples positive by the InPouch TF, as well as 132 negative samples. The assays were interpreted in series and the prevalence of T foetus shedding and 95% confidence intervals (CI) were estimated at 0.7% (95% CI: 0.0-3.9%; n = 140) from the cat clinic, 0% (95% CI: 0.0-7.7%; n = 46) from the humane society and 23.6% (95% CI: 13.2-37.0%; n = 55) from the cat shows. 'Attendance at cat shows' was the only variable significant in both the univariable and multivariable analyses (P <0.05). No significant association was found between the presence of T foetus and diarrhea at the time of sampling or having a history of diarrhea in the past 6 months. The prevalence of T foetus was highly variable among populations of cats in southern Ontario, with shedding being most common in show cats.

  7. Active Surveillance for the Management of Localized Prostate Cancer (Cancer Care Ontario Guideline): American Society of Clinical Oncology Clinical Practice Guideline Endorsement.

    PubMed

    Chen, Ronald C; Rumble, R Bryan; Loblaw, D Andrew; Finelli, Antonio; Ehdaie, Behfar; Cooperberg, Matthew R; Morgan, Scott C; Tyldesley, Scott; Haluschak, John J; Tan, Winston; Justman, Stewart; Jain, Suneil

    2016-06-20

    To endorse Cancer Care Ontario's guideline on Active Surveillance for the Management of Localized Prostate Cancer. The American Society of Clinical Oncology (ASCO) has a policy and set of procedures for endorsing clinical practice guidelines developed by other professional organizations. The Active Surveillance for the Management of Localized Prostate Cancer guideline was reviewed for developmental rigor by methodologists. The ASCO Endorsement Panel then reviewed the content and the recommendations. The ASCO Endorsement Panel determined that the recommendations from the Active Surveillance for the Management of Localized Prostate Cancer guideline, published in May 2015, are clear, thorough, and based upon the most relevant scientific evidence. ASCO endorsed the Active Surveillance for the Management of Localized Prostate Cancer guideline with added qualifying statements. The Cancer Care Ontario recommendation regarding 5-alpha reductase inhibitors was not endorsed by the ASCO panel. For most patients with low-risk (Gleason score ≤ 6) localized prostate cancer, active surveillance is the recommended disease management strategy. Factors including younger age, prostate cancer volume, patient preference, and ethnicity should be taken into account when making management decisions. Select patients with low-volume, intermediate-risk (Gleason 3 + 4 = 7) prostate cancer may be offered active surveillance. Active surveillance protocols should include prostate-specific antigen testing, digital rectal examinations, and serial prostate biopsies. Ancillary radiologic and genomic tests are investigational but may have a role in patients with discordant clinical and/or pathologic findings. Patients who are reclassified to a higher-risk category (Gleason score ≥ 7) or who have significant increases in tumor volume on subsequent biopsies should be offered active therapy. © 2016 by American Society of Clinical Oncology.

  8. American Society of Clinical Oncology Clinical Practice Guideline update on chemotherapy for stage IV non-small-cell lung cancer.

    PubMed

    Azzoli, Christopher G; Baker, Sherman; Temin, Sarah; Pao, William; Aliff, Timothy; Brahmer, Julie; Johnson, David H; Laskin, Janessa L; Masters, Gregory; Milton, Daniel; Nordquist, Luke; Pfister, David G; Piantadosi, Steven; Schiller, Joan H; Smith, Reily; Smith, Thomas J; Strawn, John R; Trent, David; Giaccone, Giuseppe

    2009-12-20

    The purpose of this article is to provide updated recommendations for the treatment of patients with stage IV non-small-cell lung cancer. A literature search identified relevant randomized trials published since 2002. The scope of the guideline was narrowed to chemotherapy and biologic therapy. An Update Committee reviewed the literature and made updated recommendations. One hundred sixty-two publications met the inclusion criteria. Recommendations were based on treatment strategies that improve overall survival. Treatments that improve only progression-free survival prompted scrutiny of toxicity and quality of life. For first-line therapy in patients with performance status of 0 or 1, a platinum-based two-drug combination of cytotoxic drugs is recommended. Nonplatinum cytotoxic doublets are acceptable for patients with contraindications to platinum therapy. For patients with performance status of 2, a single cytotoxic drug is sufficient. Stop first-line cytotoxic chemotherapy at disease progression or after four cycles in patients who are not responding to treatment. Stop two-drug cytotoxic chemotherapy at six cycles even in patients who are responding to therapy. The first-line use of gefitinib may be recommended for patients with known epidermal growth factor receptor (EGFR) mutation; for negative or unknown EGFR mutation status, cytotoxic chemotherapy is preferred. Bevacizumab is recommended with carboplatin-paclitaxel, except for patients with certain clinical characteristics. Cetuximab is recommended with cisplatin-vinorelbine for patients with EGFR-positive tumors by immunohistochemistry. Docetaxel, erlotinib, gefitinib, or pemetrexed is recommended as second-line therapy. Erlotinib is recommended as third-line therapy for patients who have not received prior erlotinib or gefitinib. Data are insufficient to recommend the routine third-line use of cytotoxic drugs. Data are insufficient to recommend routine use of molecular markers to select chemotherapy.

  9. Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update 2014

    PubMed Central

    Lyman, Gary H.; Bohlke, Kari; Khorana, Alok A.; Kuderer, Nicole M.; Lee, Agnes Y.; Arcelus, Juan Ignacio; Balaban, Edward P.; Clarke, Jeffrey M.; Flowers, Christopher R.; Francis, Charles W.; Gates, Leigh E.; Kakkar, Ajay K.; Key, Nigel S.; Levine, Mark N.; Liebman, Howard A.; Tempero, Margaret A.; Wong, Sandra L.; Somerfield, Mark R.; Falanga, Anna

    2015-01-01

    Purpose To provide current recommendations about the prophylaxis and treatment of venous thromboembolism (VTE) in patients with cancer. Methods PubMed and the Cochrane Library were searched for randomized controlled trials, systematic reviews, meta-analyses, and clinical practice guidelines from November 2012 through July 2014. An update committee reviewed the identified abstracts. Results Of the 53 publications identified and reviewed, none prompted a change in the 2013 recommendations. Recommendations Most hospitalized patients with active cancer require thromboprophylaxis throughout hospitalization. Routine thromboprophylaxis is not recommended for patients with cancer in the outpatient setting. It may be considered for selected high-risk patients. Patients with multiple myeloma receiving antiangiogenesis agents with chemotherapy and/or dexamethasone should receive prophylaxis with either low–molecular weight heparin (LMWH) or low-dose aspirin. Patients undergoing major surgery should receive prophylaxis starting before surgery and continuing for at least 7 to 10 days. Extending prophylaxis up to 4 weeks should be considered in those undergoing major abdominal or pelvic surgery with high-risk features. LMWH is recommended for the initial 5 to 10 days of treatment for deep vein thrombosis and pulmonary embolism as well as for long-term secondary prophylaxis (at least 6 months). Use of novel oral anticoagulants is not currently recommended for patients with malignancy and VTE because of limited data in patients with cancer. Anticoagulation should not be used to extend survival of patients with cancer in the absence of other indications. Patients with cancer should be periodically assessed for VTE risk. Oncology professionals should educate patients about the signs and symptoms of VTE. PMID:25605844

  10. Systemic Therapy for Stage IV Non-Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update.

    PubMed

    Hanna, Nasser; Johnson, David; Temin, Sarah; Baker, Sherman; Brahmer, Julie; Ellis, Peter M; Giaccone, Giuseppe; Hesketh, Paul J; Jaiyesimi, Ishmael; Leighl, Natasha B; Riely, Gregory J; Schiller, Joan H; Schneider, Bryan J; Smith, Thomas J; Tashbar, Joan; Biermann, William A; Masters, Gregory

    2017-08-14

    Purpose Provide evidence-based recommendations updating the 2015 ASCO guideline on systemic therapy for patients with stage IV non-small-cell lung cancer (NSCLC). Methods The ASCO NSCLC Expert Panel made recommendations based on a systematic review of randomized controlled trials from February 2014 to December 2016 plus the Cancer Care Ontario Program in Evidence-Based Care's update of a previous ASCO search. Results This guideline update reflects changes in evidence since the previous guideline update. Fourteen randomized controlled trials provide the evidence base; earlier phase trials also informed recommendation development. Recommendations New or revised recommendations include the following. Regarding first-line treatment for patients with non-squamous cell carcinoma or squamous cell carcinoma (without positive markers, eg, EGFR/ALK /ROS1), if the patient has high programmed death ligand 1 (PD-L1) expression, pembrolizumab should be used alone; if the patient has low PD-L1 expression, clinicians should offer standard chemotherapy. All other clinical scenarios follow 2015 recommendations. Regarding second-line treatment in patients who received first-line chemotherapy, without prior immune checkpoint therapy, if NSCLC tumor is positive for PD-L1 expression, clinicians should use single-agent nivolumab, pembrolizumab, or atezolizumab; if tumor has negative or unknown PD-L1 expression, clinicians should use nivolumab or atezolizumab. All immune checkpoint therapy is recommended alone plus in the absence of contraindications. For patients who received a prior first-line immune checkpoint inhibitor, clinicians should offer standard chemotherapy. For patients who cannot receive immune checkpoint inhibitor after chemotherapy, docetaxel is recommended; in patients with nonsquamous NSCLC, pemetrexed is recommended. In patients with a sensitizing EGFR mutation, disease progression after first-line epidermal growth factor receptor tyrosine kinase inhibitor therapy, and

  11. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update.

    PubMed

    Wolff, Antonio C; Hammond, M Elizabeth H; Hicks, David G; Dowsett, Mitch; McShane, Lisa M; Allison, Kimberly H; Allred, Donald C; Bartlett, John M S; Bilous, Michael; Fitzgibbons, Patrick; Hanna, Wedad; Jenkins, Robert B; Mangu, Pamela B; Paik, Soonmyung; Perez, Edith A; Press, Michael F; Spears, Patricia A; Vance, Gail H; Viale, Giuseppe; Hayes, Daniel F

    2013-11-01

    To update the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for human epidermal growth factor receptor 2 (HER2) testing in breast cancer to improve the accuracy of HER2 testing and its utility as a predictive marker in invasive breast cancer. ASCO/CAP convened an Update Committee that included coauthors of the 2007 guideline to conduct a systematic literature review and update recommendations for optimal HER2 testing. The Update Committee identified criteria and areas requiring clarification to improve the accuracy of HER2 testing by immunohistochemistry (IHC) or in situ hybridization (ISH). The guideline was reviewed and approved by both organizations. The Update Committee recommends that HER2 status (HER2 negative or positive) be determined in all patients with invasive (early stage or recurrence) breast cancer on the basis of one or more HER2 test results (negative, equivocal, or positive). Testing criteria define HER2-positive status when (on observing within an area of tumor that amounts to > 10% of contiguous and homogeneous tumor cells) there is evidence of protein overexpression (IHC) or gene amplification (HER2 copy number or HER2/CEP17 ratio by ISH based on counting at least 20 cells within the area). If results are equivocal (revised criteria), reflex testing should be performed using an alternative assay (IHC or ISH). Repeat testing should be considered if results seem discordant with other histopathologic findings. Laboratories should demonstrate high concordance with a validated HER2 test on a sufficiently large and representative set of specimens. Testing must be performed in a laboratory accredited by CAP or another accrediting entity. The Update Committee urges providers and health systems to cooperate to ensure the highest quality testing. This guideline was developed through a collaboration between the American Society of Clinical Oncology and the College of American Pathologists and

  12. Assessment of Suicidal Ideation and Behavior: Report of the International Society for CNS Clinical Trials and Methodology Consensus Meeting.

    PubMed

    Chappell, Phillip B; Stewart, Michelle; Alphs, Larry; DiCesare, Franco; DuBrava, Sarah; Harkavy-Friedman, Jill; Lim, Pilar; Ratcliffe, Sian; Silverman, Morton M; Targum, Steven D; Marder, Stephen R

    2017-06-01

    To develop consensus recommendations for assessment of suicidal ideation/suicidal behavior (SI/SB) in clinical trials. Stakeholders from academia, industry, regulatory agencies, National Institutes of Health, National Institute of Mental Health, and patient advocacy organizations participated in a consensus meeting that was sponsored by the International Society for CNS Clinical Trials and Methodology and held November 17-18, 2015. Prior to the meeting, teams of experts identified key areas of consensus and dissent related to SI/SB. The most critical issues were presented and discussed in the consensus meeting. Literature reviews and a pre-meeting survey were conducted. Findings were discussed in pre-meeting working group sessions and at the consensus meeting. Five pre-meeting working groups reviewed (1) nomenclature and classification schemes for SI/SB, (2) detection and assessment of SI/SB, (3) analysis of SI/SB data, (4) design of clinical trials for new treatments of SI/SB, and (5) public health approaches to SI/SB. A modification of the RAND/UCLA Appropriateness Method was used to combine review of scientific evidence with the collective views of experts and stakeholders to reach the final consensus statements. After discussion, all attendees voted using an electronic interactive audience response system. Areas of agreement and areas of continuing dissent were recorded. All 5 working groups agreed that a major barrier to advancement of the field of SI/SB research and the development of new treatments for SI/SB remains the lack of a universally accepted standardized nomenclature and classification system. Achieving alignment on definitions and classification of suicide-related phenomena is critical to improving the detection and assessment of SI/SB, the design of clinical trials for new treatments, and effective public health interventions.

  13. Best Practices for Dual-Energy X-ray Absorptiometry Measurement and Reporting: International Society for Clinical Densitometry Guidance.

    PubMed

    Lewiecki, E Michael; Binkley, Neil; Morgan, Sarah L; Shuhart, Christopher R; Camargos, Bruno Muzzi; Carey, John J; Gordon, Catherine M; Jankowski, Lawrence G; Lee, Joon-Kiong; Leslie, William D

    2016-01-01

    Dual-energy X-ray absorptiometry (DXA) is a technology that is widely used to diagnose osteoporosis, assess fracture risk, and monitor changes in bone mineral density (BMD). The clinical utility of DXA is highly dependent on the quality of the scan acquisition, analysis, and interpretation. Clinicians are best equipped to manage patients when BMD measurements are correct and interpretation follows well-established standards. Poor-quality acquisition, analysis, or interpretation of DXA data may mislead referring clinicians, resulting in unnecessary diagnostic evaluations, failure to evaluate when needed, inappropriate treatment, or failure to provide medical treatment, with potentially ineffective, harmful, or costly consequences. Misallocation of limited healthcare resources and poor treatment decisions can be minimized, and patient care optimized, through meticulous attention to DXA instrument calibration, data acquisition and analysis, interpretation, and reporting. This document from the International Society for Clinical Densitometry describes quality standards for BMD testing at DXA facilities worldwide to provide guidance for DXA supervisors, technologists, interpreters, and clinicians. High-quality DXA testing is necessary for correct diagnostic classification and optimal fracture risk assessment, and is essential for BMD monitoring.

  14. Clinical Oncology Society of Australia position statement on the use of complementary and alternative medicine by cancer patients.

    PubMed

    Braun, Lesley; Harris, Jessica; Katris, Paul; Cain, Michael; Dhillon, Haryana; Koczwara, Bogda; Olver, Ian; Robotin, Monica

    2014-12-01

    Health professionals involved in the clinical management of cancer are becoming increasingly aware that their patients use complementary and alternative medicine (CAM). As cancer incidence and survival rates increase, use of CAM is also likely to increase. This paper outlines the position of the Clinical Oncology Society of Australia (COSA) on the use of CAM by cancer patients and provides guidance for health professionals involved with the treatment of cancer patients who are using or wish to use CAM. Key definitions and common communication scenarios are presented along with evidence-based recommended steps for health professionals when discussing CAM use. COSA encourages health professionals to focus on open discussion with their patients regarding CAM, to become familiar with reputable resources for CAM information, to discuss with patients the concept of evidence-based medicine, to recognize limitations to their knowledge of CAM and seek further advice when necessary, and to be respectful of the patients' right to autonomy. © 2014 Wiley Publishing Asia Pty Ltd.

  15. European Society of Clinical Microbiology and Infectious Diseases: update of the diagnostic guidance document for Clostridium difficile infection.

    PubMed

    Crobach, M J T; Planche, T; Eckert, C; Barbut, F; Terveer, E M; Dekkers, O M; Wilcox, M H; Kuijper, E J

    2016-08-01

    In 2009 the first European Society of Clinical Microbiology and Infectious Diseases (ESCMID) guideline for diagnosing Clostridium difficile infection (CDI) was launched. Since then newer tests for diagnosing CDI have become available, especially nucleic acid amplification tests. The main objectives of this update of the guidance document are to summarize the currently available evidence concerning laboratory diagnosis of CDI and to formulate and revise recommendations to optimize CDI testing. This update is essential to improve the diagnosis of CDI and to improve uniformity in CDI diagnosis for surveillance purposes among Europe. An electronic search for literature concerning the laboratory diagnosis of CDI was performed. Studies evaluating a commercial laboratory test compared to a reference test were also included in a meta-analysis. The commercial tests that were evaluated included enzyme immunoassays (EIAs) detecting glutamate dehydrogenase, EIAs detecting toxins A and B and nucleic acid amplification tests. Recommendations were formulated by an executive committee, and the strength of recommendations and quality of evidence were graded using the Grades of Recommendation Assessment, Development and Evaluation (GRADE) system. No single commercial test can be used as a stand-alone test for diagnosing CDI as a result of inadequate positive predictive values at low CDI prevalence. Therefore, the use of a two-step algorithm is recommended. Samples without free toxin detected by toxins A and B EIA but with positive glutamate dehydrogenase EIA, nucleic acid amplification test or toxigenic culture results need clinical evaluation to discern CDI from asymptomatic carriage.

  16. Improving quality and decreasing cost in gynecologic oncology care. Society of gynecologic oncology recommendations for clinical practice.

    PubMed

    Rimel, B J; Burke, William M; Higgins, Robert V; Lee, Paula S; Lutman, Christopher V; Parker, Lynn

    2015-05-01

    To identify potential cost savings in gynecologic oncology care without sacrificing quality. Members of the Clinical Practice Committee of the Society of Gynecologic Oncology were asked to review current practice patterns in gynecologic oncology and assess the potential for cost savings founded on evidence-based medicine and current guidelines. Five clinical practices were identified including the following: vaginal cytology for endometrial cancer survivors; colposcopy for low grade cytologic abnormalities for cervical cancer survivors; routine imaging studies for gynecologic cancer survivors; screening for ovarian cancer with serum biomarkers and ultrasound; and improving palliative care for gynecologic cancer patients. Review of the published literature and guidelines were performed to make evidence-based recommendations for cost effective quality gynecologic oncology care. • Do not perform Pap tests of the vaginal cuff in patients with a history of endometrial cancer. • Do not perform colposcopy for low grade Pap tests in women with a history of cervical cancer. • Avoid routine imaging for cancer surveillance in asymptomatic women with gynecologic cancer, specifically ovarian, endometrial, cervical, vulvar and vaginal cancer. • Do not screen women at low risk for ovarian cancer with ultrasound or CA-125 or other biomarkers. • Do not delay basic level palliative care for women with advanced or relapsed gynecologic cancer, do refer to a palliative care specialist when needed, and avoid unnecessary treatments at life's end. Copyright © 2015 Elsevier Inc. All rights reserved.

  17. THE AMERICAN SOCIETY OF CLINICAL PSYCHOPHARMACOLOGY SURVEY OF PSYCHOPHARMACOLOGISTS' PRACTICE PATTERNS FOR THE TREATMENT OF MOOD DISORDERS.

    PubMed

    Goldberg, Joseph F; Freeman, Marlene P; Balon, Richard; Citrome, Leslie; Thase, Michael E; Kane, John M; Fava, Maurizio

    2015-08-01

    Optimal successive treatment decisions are not well established after an initial medication nonresponse in major depressive disorder or bipolar disorder. While practice guidelines offer consensus-based expert treatment recommendations, little is known about "real world" pharmacology decision making by practicing psychopharmacologists. We surveyed via Internet the national membership of the American Society of Clinical Psychopharmacology (ASCP) to study preferred pharmacotherapy strategies and factors that influence medication choices for patients with mood disorders. Surveys were returned by 154/752 ASCP members (21%). After nonresponse to a serotonin reuptake inhibitor in major depressive disorder, participants equally favored switching within or across antidepressant classes. After a partial response, adjunctive bupropion was the preferred intervention, followed by changing antidepressant classes. Atypical antipsychotic augmentation was only a fourth-line consideration, even though moderate or marked efficacy was perceived in most instances with olanzapine, aripiprazole, and quetiapine. Respondents favored avoiding antidepressants in bipolar I patients with mixed/cycling features or prior antidepressant-associated mania/hypomania. In rapid cyclers, they advocated antidepressant cessation and preferred the use of atypical antipsychotics and lamotrigine. Participating psychopharmacologists treating adults with mood disorders report prescribing medications that largely mirror the evidence base with only a few notable exceptions, in consideration of the characteristics of definable clinical subpopulations. © 2015 Wiley Periodicals, Inc.

  18. Clinical Equipoise and Shared Decision-making in Pulmonary Nodule Management. A Survey of American Thoracic Society Clinicians.

    PubMed

    Iaccarino, Jonathan M; Simmons, James; Gould, Michael K; Slatore, Christopher G; Woloshin, Steven; Schwartz, Lisa M; Wiener, Renda Soylemez

    2017-06-01

    Guidelines for pulmonary nodule evaluation suggest a variety of strategies, reflecting the lack of high-quality evidence demonstrating the superiority of any one approach. It is unclear whether clinicians agree that multiple management options are appropriate at different levels of risk and whether this impacts their decision-making approaches with patients. To assess clinicians' perceptions of the appropriateness of various diagnostic strategies, approach to decision-making, and perceived clinical equipoise in pulmonary nodule evaluation. We developed and administered a web-based survey in March and April, 2014 to clinician members of the American Thoracic Society. The primary outcome was perceived appropriateness of pulmonary nodule evaluation strategies in three clinical vignettes with different malignancy risk. We compared responses to guideline recommendations and analyzed clinician characteristics associated with a reported shared decision-making approach. We also assessed clinicians' likelihood to enroll patients in hypothetical randomized trials comparing nodule evaluation strategies. Of 5,872 American Thoracic Society members e-mailed, 1,444 opened the e-mail and 428 eligible clinicians participated in the survey (response rate, 30.0% among those who opened the invitation; 7% overall). The mean number of options considered appropriate increased with pretest probability of cancer, ranging from 1.8 (SD, 1.2) for the low-risk case to 3.5 (1.1) for the high-risk case (P < 0.0001). As recommended by guidelines, the proportion that deemed surgical resection as an appropriate option also increased with cancer risk (P < 0.0001). One-half of clinicians (50.4%) reported engaging in shared decision-making with patients for pulmonary nodule management; this was more commonly reported by clinicians with more years of experience (P = 0.01) and those who reported greater comfort in managing pulmonary nodules (P = 0.005). Although one-half (49.9%) deemed

  19. Use of Biomarkers to Guide Decisions on Systemic Therapy for Women With Metastatic Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline.

    PubMed

    Van Poznak, Catherine; Somerfield, Mark R; Bast, Robert C; Cristofanilli, Massimo; Goetz, Matthew P; Gonzalez-Angulo, Ana M; Hicks, David G; Hill, Elizabeth G; Liu, Minetta C; Lucas, Wanda; Mayer, Ingrid A; Mennel, Robert G; Symmans, William F; Hayes, Daniel F; Harris, Lyndsay N

    2015-08-20

    To provide recommendations on the appropriate use of breast tumor biomarker assay results to guide decisions on systemic therapy for metastatic breast cancer. A literature search and prospectively defined study selection identified systematic reviews, meta-analyses, randomized controlled trials (RCTs), prospective-retrospective studies, and prospective comparative observational studies published from 2006 through September 2014. The literature search revealed 17 articles that met criteria for further review: 11 studies reporting discordances between primary tumors and metastases in expression of hormone receptors or human epidermal growth factor receptor 2 (HER2), one RCT that addressed the use of a biomarker to decide whether to change or continue a treatment regimen, and five prospective-retrospective studies that evaluated the clinical utility of biomarkers. In patients with accessible metastases, biopsy for confirmation of disease process and retesting of estrogen receptor, progesterone receptor, and HER2 status should be offered, but evidence is lacking to determine whether changing anticancer treatment on the basis of change in receptor status affects clinical outcomes. With discordance of results between primary and metastatic tissues, the Panel consensus is to use preferentially the estrogen receptor, progesterone receptor, and HER2 status of the metastasis to direct therapy if supported by the clinical scenario and patient's goals for care. Carcinoembryonic antigen, cancer antigen 15-3, and cancer antigen 27-29 may be used as adjunctive assessments, but not alone, to contribute to decisions regarding therapy. Recommendations for tumor rebiopsy and use of circulating tumor markers are based on clinical experience and Panel informal consensus in the absence of studies designed to evaluate the clinical utility of the markers. As such, it is also reasonable for clinicians to not use these markers as adjunctive assessments. © 2015 by American Society of

  20. 2013 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards Including Standards for the Safe Administration and Management of Oral Chemotherapy

    PubMed Central

    Neuss, Michael N.; Polovich, Martha; McNiff, Kristen; Esper, Peg; Gilmore, Terry R.; LeFebvre, Kristine B.; Schulmeister, Lisa; Jacobson, Joseph O.

    2013-01-01

    In 2009, ASCO and the Oncology Nursing Society (ONS) published standards for the safe use of parenteral chemotherapy in the outpatient setting, including issues of practitioner orders, preparation, and administration of medication. In 2011, these were updated to include inpatient facilities. In December 2011, a multistakeholder workgroup met to address the issues associated with orally administered antineoplastics, under the leadership of ASCO and ONS. The workgroup participants developed recommended standards, which were presented for public comment. Public comments informed final edits, and the final standards were reviewed and approved by the ASCO and ONS Boards of Directors. Significant newly identified recommendations include those associated with drug prescription and the necessity of ascertaining that prescriptions are filled. In addition, the importance of patient and family education regarding administration schedules, exception procedures, disposal of unused oral medication, and aspects of continuity of care across settings were identified. This article presents the newly developed standards. PMID:23914148

  1. Amyloid fibril proteins and amyloidosis: chemical identification and clinical classification International Society of Amyloidosis 2016 Nomenclature Guidelines.

    PubMed

    Sipe, Jean D; Benson, Merrill D; Buxbaum, Joel N; Ikeda, Shu-Ichi; Merlini, Giampaolo; Saraiva, Maria J M; Westermark, Per

    2016-12-01

    The Nomenclature Committee of the International Society of Amyloidosis (ISA) met during the XVth Symposium of the Society, 3 July-7 July 2016, Uppsala, Sweden, to assess and formulate recommendations for nomenclature for amyloid fibril proteins and the clinical classification of the amyloidoses. An amyloid fibril must exhibit affinity for Congo red and with green, yellow or orange birefringence when the Congo red-stained deposits are viewed with polarized light. While congophilia and birefringence remain the gold standard for demonstration of amyloid deposits, new staining and imaging techniques are proving useful. To be included in the nomenclature list, in addition to congophilia and birefringence, the chemical identity of the protein must be unambiguously characterized by protein sequence analysis when possible. In general, it is insufficient to identify a mutation in the gene of a candidate amyloid protein without confirming the variant changes in the amyloid fibril protein. Each distinct form of amyloidosis is uniquely characterized by the chemical identity of the amyloid fibril protein that deposits in the extracellular spaces of tissues and organs and gives rise to the disease syndrome. The fibril proteins are designated as protein A followed by a suffix that is an abbreviation of the parent or precursor protein name. To date, there are 36 known extracellular fibril proteins in humans, 2 of which are iatrogenic in nature and 9 of which have also been identified in animals. Two newly recognized fibril proteins, AApoCII derived from apolipoprotein CII and AApoCIII derived from apolipoprotein CIII, have been added. AApoCII amyloidosis and AApoCIII amyloidosis are hereditary systemic amyloidoses. Intracellular protein inclusions displaying some of the properties of amyloid, "intracellular amyloid" have been reported. Two proteins which were previously characterized as intracellular inclusions, tau and α-synuclein, are now recognized to form extracellular

  2. FESCC survey on accreditation and post-graduate training in clinical chemistry in European countries. Federation of European Societies of Clinical Chemistry.

    PubMed

    Rossier, M; Blaton, V; Franzini, C; Queralto, J M; Palicka, V

    2000-04-01

    Promotion of the professional growth and development of specialists in the field of clinical chemistry in European countries, and harmonisation of quality assessment and accreditation procedures are listed among the main goals and activities of Federation of European Societies of Clinical Chemistry (FESCC), according to its 1999-2000 strategic plan. The European countries that are members of the European Union are in the process of establishing the "European Register for Clinical Chemists", based on minimum standards of education, training and experience as defined by the European Communities Confederation of Clinical Chemists (EC4). Many other European countries would like to adapt their system of professional education to this model. Data on post-graduate training in EC4 FESCC members have already been gathered in 1998. However, at the present time, there is no detailed knowledge of pre- and post-graduate professional education of specialists in clinical chemistry in the non-EC4 European countries. FESCC launched a survey in July 1998 in order to gather this information with the hope to start a database about existing systems. All FESCC members received the same questionnaire on accreditation (seven questions) and non-EC4 FESCC members received an additional questionnaire with 11 questions related to post-graduate training in clinical chemistry. The response rate of the 35 FESCC member countries was 93% from the 15 EC4 members (14 responses/15 countries) and 80% from the 20-non-EC4 (16 responses/20 countries). The heterogeneity of the data on post-graduate training in clinical chemistry indicates that a great effort will be needed before harmonisation is reached. These results, however, will provide an interesting basis for further discussion and promotion of post-graduate training in clinical chemistry. The data provided on accreditation show that the total number of accredited laboratories was relatively low in EC4 countries and even lower in non-EC4 members

  3. Revisions to the 2009 american society of clinical oncology/oncology nursing society chemotherapy administration safety standards: expanding the scope to include inpatient settings.

    PubMed

    Jacobson, Joseph O; Polovich, Martha; Gilmore, Terry R; Schulmeister, Lisa; Esper, Peg; Lefebvre, Kristine B; Neuss, Michael N

    2012-01-01

    In November 2009, ASCO and the Oncology Nursing Society (ONS) jointly published a set of 31 voluntary chemotherapy safety standards for adult patients with cancer, as the end result of a highly structured, multistakeholder process. The standards were explicitly created to address patient safety in the administration of parenteral and oral chemotherapeutic agents in outpatient oncology settings. In January 2011, a workgroup consisting of ASCO and ONS members was convened to review feedback received since publication of the standards, to address interim changes in practice, and to modify the standards as needed. The most significant change to the standards is to extend their scope to the inpatient setting. This change reflects the conviction that the same standards for chemotherapy administration safety should apply in all settings. The proposed set of standards has been approved by the Board of Directors for both ASCO and ONS and has been posted for public comment. Comments were used as the basis for final editing of the revised standards. The workgroup recognizes that the safety of oral chemotherapy usage, nononcology medication reconciliation, and home chemotherapy administration are not adequately addressed in the original or revised standards. A separate process, cosponsored by ASCO and ONS, will address the development of safety standards for these areas.

  4. Diagnosis and Treatment of Leishmaniasis: Clinical Practice Guidelines by the Infectious Diseases Society of America (IDSA) and the American Society of Tropical Medicine and Hygiene (ASTMH).

    PubMed

    Aronson, Naomi; Herwaldt, Barbara L; Libman, Michael; Pearson, Richard; Lopez-Velez, Rogelio; Weina, Peter; Carvalho, Edgar M; Ephros, Moshe; Jeronimo, Selma; Magill, Alan

    2016-12-15

    It is important to realize that leishmaniasis guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations. The IDSA and ASTMH consider adherence to these guidelines to be voluntary, with the ultimate determinations regarding their application to be made by the physician in the light of each patient's individual circumstances.

  5. The Endocrine Society's Clinical Practice Guideline on endocrine and nutritional management of the post-bariatric surgery patient: commentary from a European Perspective.

    PubMed

    Torres, Antonio J; Rubio, Miguel A

    2011-08-01

    Bariatric and metabolic surgery is experiencing a noteworthy increase worldwide in recent years, but protocols and consensus published in the past decade have not yet established clear evidence-based clinical recommendations. The Endocrine Society, with the participation of the European Society of Endocrinology, has promoted the creation of an expert panel to propose a clinical practice guideline for postoperative management of patients, candidates to bariatric surgery, that places a particular emphasis on evidence-based medical aspects. The main arguments reflected in those recommendations are set out in this article and are subject to analysis and discussion from the specific viewpoint of the current European experience.

  6. Clinical practice guidelines for the diagnosis and management of osteoporosis. Scientific Advisory Board, Osteoporosis Society of Canada.

    PubMed Central

    1996-01-01

    OBJECTIVE: To recommend clinical practice guidelines for the assessment of people at risk for osteoporosis, and for effective diagnosis and management of the condition. OPTIONS: Screening and diagnostic methods: risk-factor assessment, clinical evaluation, measurement of bone mineral density, laboratory investigations. Prophylactic and corrective therapies: calcium and vitamin D nutritional supplementation, physical activity and fall-avoidance techniques, ovarian hormone therapy, bisphosphonate drugs, other drug therapies. Pain-management medications and techniques. OUTCOMES: Prevention of loss of bone mineral density and fracture; increased bone mass; and improved quality of life. EVIDENCE: Epidemiologic and clinical studies and reports were examined, with emphasis on recent randomized controlled trials. Clinical practice in Canada and elsewhere was surveyed. Availability of treatment products and diagnostic equipment in Canada was considered. VALUES: Cost-effective methods and products that can be adopted across Canada were considered. A high value was given to accurate assessment of fracture risk and osteoporosis, and to increasing bone mineral density, reducing fractures and fracture risk and minimizing side effects of diagnosis and treatment. BENEFITS, HARMS AND COSTS: Proper diagnosis and management of osteoporosis minimize injury and disability, improve quality of life for patients and reduce costs to society. Rationally targeted methods of screening and diagnosis are safe and cost effective. Harmful side effects and costs of recommended therapies are minimal compared with the harms and costs of untreated osteoporosis. Alternative therapies provide a range of choices for physicians and patients. RECOMMENDATIONS: Population sets at high risk should be identified and then the diagnosis confirmed through bone densitometry. Dual-energy x-ray absorptiometry is the preferred measurement technique. Radiography can be adjunct when indicated. Calcium and vitamin D

  7. [Consensus on the detection and management of prediabetes. Consensus and Clinical Guidelines Working Group of the Spanish Diabetes Society].

    PubMed

    Mata-Cases, M; Artola, S; Escalada, J; Ezkurra-Loyola, P; Ferrer-García, J C; Fornos, J A; Girbés, J; Rica, I

    2015-01-01

    In Spain, according to the Di@bet.es study, 13.8% of the adult population suffers from diabetes and 14.8% from some form of prediabetes (impaired glucose tolerance, impaired fasting glucose or both). Since early detection of prediabetes can facilitate the implementation of therapeutic measures to prevent its progression to diabetes, we believe that preventive strategies in primary care and specialized clinical settings should be agreed. Screening for diabetes and prediabetes using a specific questionnaire (FINDRISC) and/or the measurement of fasting plasma glucose in high risk patients leads to detecting patients at risk of developing diabetes and it is necessary to consider how they should be managed. The intervention in lifestyle can reduce the progression to diabetes and reverse a prediabetic state to normal and is a cost-effective intervention. Some drugs, such as metformin, have also been shown effective in reducing the progression to diabetes but are not superior to non-pharmacological interventions. Finally, an improvement in some cardiovascular risk factors has been observed although there is no strong evidence supporting the effectiveness of screening in terms of morbility and mortality. The Consensus and Clinical Guidelines Working Group of the Spanish Diabetes Society has issued some recommendations that have been agreed by the Sociedad Española de Endocrinología y Nutrición, Sociedad Española de Endocrinología Pediátrica, Sociedad Española de Farmacia Comunitaria, Sociedad Española de Medicina Familiar y Comunitaria, Sociedad Española de Médicos Generales, Sociedad Española de Médicos de Atención Primaria, Sociedad Española de Medicina Interna, Asociación de Enfermería Comunitaria and Red de Grupos de Estudio de la Diabetes en Atención Primaria. Copyright © 2015. Publicado por Elsevier España, S.L.U.

  8. Consensus on the detection and management of prediabetes. Consensus and Clinical Guidelines Working Group of the Spanish Diabetes Society.

    PubMed

    Mata-Cases, M; Artola, S; Escalada, J; Ezkurra-Loyola, P; Ferrer-García, J C; Fornos, J A; Girbés, J; Rica, I

    2015-03-01

    In Spain, according to the Di@bet.es study, 13.8% of the adult population suffers from diabetes and 14.8% from some form of prediabetes (impaired glucose tolerance, impaired fasting glucose or both). Since early detection of prediabetes can facilitate the implementation of therapeutic measures to prevent its progression to diabetes, we believe that preventive strategies in primary care and specialized clinical settings should be agreed. Screening for diabetes and prediabetes using a specific questionnaire (FINDRISC) and/or the measurement of fasting plasma glucose in high risk patients leads to detecting patients at risk of developing diabetes and it is necessary to consider how they should be managed. The intervention in lifestyle can reduce the progression to diabetes and reverse a prediabetic state to normal and is a cost-effective intervention. Some drugs, such as metformin, have also been shown effective in reducing the progression to diabetes but are not superior to non-pharmacological interventions. Finally, an improvement in some cardiovascular risk factors has been observed although there is no strong evidence supporting the effectiveness of screening in terms of morbility and mortality. The Consensus and Clinical Guidelines Working Group of the Spanish Diabetes Society has issued some recommendations that have been agreed by the Sociedad Española de Endocrinología y Nutrición, Sociedad Española de Endocrinología Pediátrica, Sociedad Española de Farmacia Comunitaria, Sociedad Española de Medicina Familiar y Comunitaria, Sociedad Española de Médicos Generales, Sociedad Española de Médicos de Atención Primaria, Sociedad Española de Medicina Interna, Asociación de Enfermería Comunitaria and Red de Grupos de Estudio de la Diabetes en Atención Primaria. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

  9. Updates in Gastrointestinal Oncology – insights from the 2008 44th annual meeting of the American Society of Clinical Oncology

    PubMed Central

    Javle, Milind; Hsueh, Chung-Tsen

    2009-01-01

    We have reviewed the pivotal presentations rcelated to colorectal cancer (CRC) and other gastrointestinal malignancies from 2008 annual meeting of the American Society of Clinical Oncology (ASCO). We have discussed the scientific findings and the impact on practice guidelines and ongoing clinical trials. The report on KRAS status in patients with metastatic CRC receiving epidermal growth factor receptor (EGFR) targeted antibody treatment has led to a change in National Comprehensive Cancer Network guideline that recommends only patients with wild-type KRAS tumor should receive this treatment. The results of double biologics (bevacizumab and anti-EGFR antibody) plus chemotherapy as first-line treatment in patients with metastatic CRC has shown a worse outcome than bevacizumab-based regimen. Microsatellite Instability has again been confirmed to be an important predictor in patients with stage II colon cancer receiving adjuvant treatment. Adjuvant gemcitabine therapy for pancreatic cancer was investigated by the CONKO-001 study; this resulted in superior survival as compared with observation and can be regarded as an acceptable option, without the addition of radiotherapy. The addition of bevacizumab to gemcitabine and erlotinib was not supior to gemcitabine and erlotinib for advanced disease. Second-line therapy for advanced pancreatic cancer with 5-fluorouracil and oxaliplatin resulted in a survival benefit. Irinotecan plus cisplatin and paclitaxel plus cisplatin result in similar survival when combined with radiotherapy for esophageal cancer. The novel fluoropyrimidine S1 appears to be active in gastric cancer, as a single agent or as combination therapy. Adjuvant intraperitoneal mitomycin-C may decrease the incidence of peritoneal recurrence of gastric cancer. Sorafenib is an effective agent in Asian patients with hepatocellular carcinoma secondary to hepatitis B; its utility in child's B cirrhosis remains to be proven. Sunitinib is also an active agent in

  10. The clinical research office of the endourological society ureteroscopy global study: indications, complications, and outcomes in 11,885 patients.

    PubMed

    de la Rosette, Jean; Denstedt, John; Geavlete, Petrisor; Keeley, Francis; Matsuda, Tadashi; Pearle, Margaret; Preminger, Glenn; Traxer, Olivier

    2014-02-01

    To assess the current indications for ureteroscopy (URS) treatment, outcome in terms of stone-free rate, and intra- and postoperative complications using the modified Clavien grading system. The Clinical Research Office of the Endourological Society collected prospective data as part of the URS Global Study for consecutive patients treated with URS at centers around the world for 1 year. URS was performed according to study protocol and local clinical practice guidelines. The stone size and location were recorded and postoperative outcome and complications, graded according to the modified Clavien grading system, reported. Between January 2010 and October 2012, 11,885 patients received URS at 114 centers in 32 countries; 1852 had only renal stones, 8676 had only ureteral stones, and 1145 patients had both types of stone. Fragmentation was performed principally using a laser device (49.0%) or a pneumatic device (30.3%); no device was used in 17.9% of the patients. A high stone-free rate (85.6%) was achieved. The large majority of patients did not receive any further treatment for renal or ureter stones (89.4%). The postoperative complication rate was low (3.5%). The most frequent complication was fever (1.8%); a blood transfusion was required in 0.2% of patients. The majority of complications were Clavien grade I or II (2.8% of patients). URS is an established minimal invasive treatment for urinary stones with a high success rate and low morbidity. Recent advances have expanded the indication for urinary stones, which now ranges from treatment of smaller sized distal ureter stones by semirigid URS to larger sized renal pelvis stones treated by flexible URS.

  11. Clinical management of drug-induced hypertension: 2013 Practical Recommendations of the Italian Society of Hypertension (SIIA).

    PubMed

    Virdis, Agostino; Ghiadoni, Lorenzo; Taddei, Stefano

    2014-03-01

    Results from recent observational studies conducted in our country and including approximately 160,000 patients with hypertension, reported that only 37 % of patients achieve effective blood pressure control under treatment. These data confirm that blood pressure control amongst the hypertensive population is still largely unsatisfactory in Italy. For this reason, the Italian Society of Hypertension aims to generate a number of interventions to improve blood pressure control in Italy, including integrated actions with General Practitioners, the implementation of hypertension awareness in the general population, a larger use of home blood pressure measurements, and a survey aimed at identifying all clinical and excellence centers for hypertension diagnosis and treatment throughout the whole national territory. Many therapeutic agents or chemical substances can induce a persistent or transient increase in blood pressure or interfere with the effect of antihypertensive drugs, causing sodium retention and expansion of the extra-cellular volume, activating the sympathetic nervous system and inducing vasoconstriction. This aspect represents one of the most common cause of secondary forms of hypertension, which often is under-evaluated by the physicians. In this review article, the potential causes of secondary forms of hypertension caused by use/abuse of drugs or substances are summarized.

  12. The Society for Clinical Trials opposes US legislation to permit marketing of unproven medical therapies for seriously ill patients.

    PubMed

    2006-01-01

    The proposed Bill S.1956 is a bad law. Wide early access to minimally tested treatments cannot be expected to lead to better or more compassionate care of the seriously ill patient. The long history of medicine is replete with treatments that initially seemed promising to patients, doctors, and especially to their own inventors, but which careful study revealed to be worthless or harmful. We understand the desperate plight of these patients and the importance of hope for them and their families. However, although the proposed law is portrayed as an effort to help patients in desperate need of treatment, in fact its effect would be to undermine the system of scientifically valid testing of new drugs that has been a bulwark of health care for several decades. The effect of the law would be to provide many more possible choices of treatment but much less information upon which to make the choice. Patients would be very unlikely to end up receiving an effective treatment. They would be much more likely to receive useless or possibly harmful treatments in the last days of their lives. The Society for Clinical Trials strongly opposes this legislation.

  13. American Society of Clinical Oncology clinical practice guideline for the use of larynx-preservation strategies in the treatment of laryngeal cancer.

    PubMed

    Pfister, David G; Laurie, Scott A; Weinstein, Gregory S; Mendenhall, William M; Adelstein, David J; Ang, K Kian; Clayman, Gary L; Fisher, Susan G; Forastiere, Arlene A; Harrison, Louis B; Lefebvre, Jean-Louis; Leupold, Nancy; List, Marcy A; O'Malley, Bernard O; Patel, Snehal; Posner, Marshall R; Schwartz, Michael A; Wolf, Gregory T

    2006-08-01

    To develop a clinical practice guideline for treatment of laryngeal cancer with the intent of preserving the larynx (either the organ itself or its function). This guideline is intended for use by oncologists in the care of patients outside of clinical trials. A multidisciplinary Expert Panel determined the clinical management questions to be addressed and reviewed the literature available through November 2005, with emphasis given to randomized controlled trials of site-specific disease. Survival, rate of larynx preservation, and toxicities were the principal outcomes assessed. The guideline underwent internal review and approval by the Panel, as well as external review by additional experts, members of the American Society of Clinical Oncology (ASCO) Health Services Committee, and the ASCO Board of Directors. Evidence supports the use of larynx-preservation approaches for appropriately selected patients without a compromise in survival; however, no larynx-preservation approach offers a survival advantage compared with total laryngectomy and adjuvant therapy with rehabilitation as indicated. All patients with T1 or T2 laryngeal cancer, with rare exception, should be treated initially with intent to preserve the larynx. For most patients with T3 or T4 disease without tumor invasion through cartilage into soft tissues, a larynx-preservation approach is an appropriate, standard treatment option, and concurrent chemoradiotherapy therapy is the most widely applicable approach. To ensure an optimum outcome, special expertise and a multidisciplinary team are necessary, and the team should fully discuss with the patient the advantages and disadvantages of larynx-preservation options compared with treatments that include total laryngectomy.

  14. Clinical and Research Considerations for Patients With Hypertensive Acute Heart Failure: A Consensus Statement from the Society for Academic Emergency Medicine and the Heart Failure Society of America Acute Heart Failure Working Group.

    PubMed

    Collins, Sean P; Levy, Phillip D; Martindale, Jennifer L; Dunlap, Mark E; Storrow, Alan B; Pang, Peter S; Albert, Nancy M; Felker, G Michael; Fermann, Gregory J; Fonarow, Gregg C; Givertz, Michael M; Hollander, Judd E; Lanfear, David E; Lenihan, Daniel J; Lindenfeld, JoAnn M; Peacock, W Frank; Sawyer, Douglas B; Teerlink, John R; Butler, Javed

    2016-08-01

    Management approaches for patients in the emergency department (ED) who present with acute heart failure (AHF) have largely focused on intravenous diuretics. Yet, the primary pathophysiologic derangement underlying AHF in many patients is not solely volume overload. Patients with hypertensive AHF (H-AHF) represent a clinical phenotype with distinct pathophysiologic mechanisms that result in elevated ventricular filling pressures. To optimize treatment response and minimize adverse events in this subgroup, we propose that clinical management be tailored to a conceptual model of disease that is based on these mechanisms. This consensus statement reviews the relevant pathophysiology, clinical characteristics, approach to therapy, and considerations for clinical trials in ED patients with H-AHF. © 2016 by the Society for Academic Emergency Medicine.

  15. American Epilepsy Society

    MedlinePlus

    ... Epilepsy Society CLINICAL RESOURCES FAQs GUIDELINES IOM EPILEPSY MEDICAL MARIJUANA SUDEP SURGERY DEVICES GENETICS TREATMENTS Drug Alerts and ... RESOURCES Navigation CLINICAL RESOURCES FAQs GUIDELINES IOM EPILEPSY MEDICAL MARIJUANA SUDEP SURGERY DEVICES GENETICS TREATMENTS Drug Alerts and ...

  16. Clinical cancer advances 2007: major research advances in cancer treatment, prevention, and screening--a report from the American Society of Clinical Oncology.

    PubMed

    Gralow, Julie; Ozols, Robert F; Bajorin, Dean F; Cheson, Bruce D; Sandler, Howard M; Winer, Eric P; Bonner, James; Demetri, George D; Curran, Walter; Ganz, Patricia A; Kramer, Barnett S; Kris, Mark G; Markman, Maurie; Mayer, Robert J; Raghavan, Derek; Ramsey, Scott; Reaman, Gregory H; Sawaya, Raymond; Schuchter, Lynn M; Sweetenham, John W; Vahdat, Linda T; Davidson, Nancy E; Schilsky, Richard L; Lichter, Allen S

    2008-01-10

    A MESSAGE FROM ASCO'S PRESIDENT: For the third year, the American Society of Clinical Oncology (ASCO) is publishing Clinical Cancer Advances: Major Research Advances in Cancer Treatment, Prevention, and Screening, an annual review of the most significant cancer research presented or published over the past year. ASCO publishes this report to demonstrate the important progress being made on the front lines of clinical cancer research today. The report is intended to give all those with an interest in cancer care-the general public, cancer patients and organizations, policymakers, oncologists, and other medical professionals-an accessible summary of the year's most important cancer research advances. These pages report on the use of magnetic resonance imaging for breast cancer screening, the association between hormone replacement therapy and breast cancer incidence, the link between human papillomavirus and head and neck cancers, and the use of radiation therapy to prevent lung cancer from spreading. They also report on effective new targeted therapies for cancers that have been historically difficult to treat, such as liver cancer and kidney cancer, among many others. A total of 24 advances are featured in this year's report. These advances and many more over the past several years show that the nation's long-term investment in cancer research is paying off. But there are disturbing signs that progress could slow. We are now in the midst of the longest sustained period of flat government funding for cancer research in history. The budgets for the National Institutes of Health and the National Cancer Institute (NCI) have been unchanged for four years. When adjusted for inflation, cancer research funding has actually declined 12% since 2004. These budget constraints limit the NCI's ability to fund promising cancer research. In the past several years the number of grants that the NCI has been able to fund has significantly decreased; this year, in response to just the

  17. [Clinical guidelines for diagnosing, treatment and monitoring patients with bladder cancer--Croatian Oncology Society and Croatian Urology Society, Croatian Medical Association].

    PubMed

    Gamulin, Marija; Ruzić, Ira Pavlović; Grgić, Mislav; Jazvić, Marijana; Solarić, Mladen; Zahirović, Dag; Zorica, Robert; Omrcen, Tomislav; Petković, Marija; Matić, Mate; Fuckar, Zeljko; Ruzić, Boris; Pasini, Josip; Situm, Marijan; Dordević, Gordana; Miletić, Damir; Tadić, Tade; Kastelan, Zeljko; Librenjak, Davor; Gilja, Ivan; Vilović, Katarina; Kruslin, Bozo; Kuvezdić, Hrvoje

    2013-01-01

    Urothelial cancer is the most common bladder cancer. Hematuria is the most common presenting symptom in patients with bladder cancer. The most common diagnostics of bladder cancer is performed by transurethral resection of bladder after which pathohistological diagnosis is set. It is necessary to determine whether the cancer penetrated in muscle layer (muscle-invasive cancer) or not (muscle-noninvasive cancer). Decision on therapeutic modality depends on the clinical stage of disease and on prognostic and risk factors. For muscle non-invasive bladder cancer transurethral resection is preferred with or without intravesical instillation of Bacillus Calmette-Guérin (BCG). For invasive cancer the method of choice is radical cystectomy. Radiotherapy is used in radical and palliative purposes. Metastatic disease is most frequently treated by chemotherapy metotrexate/vinblastine/doxorubicine/cisplatin (MVAC) or gemcitabine/cisplatin (GC). The purpose of this article is to present clinical recommendations to set standards of procedures and criteria in diagnostics, treatment and follow up of patients with bladder cancer in the Republic of Croatia.

  18. American Society of Clinical Oncology policy statement update: tobacco control--reducing cancer incidence and saving lives. 2003.

    PubMed

    2003-07-15

    As an international medical society dedicated to cancer prevention, the American Society of Clinical Oncology (ASCO) advocates a fundamental reform of United States and international policy toward addictive tobacco products. ASCO's goal is the immediate reduction of tobacco use and ultimate achievement of a tobacco-free world. The centerpiece of ASCO's policy is the recommendation for an independent commission to study the tobacco problem in all of its dimensions: social, medical, legal, and economic (both domestically and globally). The commission membership should include broad-based representation and expertise on tobacco issues. In ASCO's view, tobacco control efforts to date have been less than successful because they are too fragmented and incremental, leaving many important issues unaddressed. A more comprehensive solution could flow from this study, including input from a variety of government agencies involved with public health, agriculture, First Amendment and other legal considerations, and international trade. The study, within defined time limits, should culminate in a report that outlines a strategy for achieving immediate reduction of tobacco use and ultimate achievement of a tobacco-free world, including explicit plans and a timetable for implementation. Although this comprehensive approach to tobacco control will take many years to implement even under the best of circumstances, there are certain measures that could be undertaken immediately with meaningful impact on tobacco usage. These include: Increasing efforts to discourage tobacco use, particularly among the young Raising federal excise taxes by at least $2 per pack and encouraging states to consider tobacco taxes as a first resort in revenue enhancement Ensuring that tobacco settlement funds be devoted only to health-related projects, including medical treatment, biomedical research, and tobacco prevention efforts Requiring disclosure of all ingredients in tobacco products Comprehensively

  19. Management of Adults With Hospital-acquired and Ventilator-associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society.

    PubMed

    Kalil, Andre C; Metersky, Mark L; Klompas, Michael; Muscedere, John; Sweeney, Daniel A; Palmer, Lucy B; Napolitano, Lena M; O'Grady, Naomi P; Bartlett, John G; Carratalà, Jordi; El Solh, Ali A; Ewig, Santiago; Fey, Paul D; File, Thomas M; Restrepo, Marcos I; Roberts, Jason A; Waterer, Grant W; Cruse, Peggy; Knight, Shandra L; Brozek, Jan L

    2016-09-01

    It is important to realize that guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations. IDSA considers adherence to these guidelines to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient's individual circumstances.These guidelines are intended for use by healthcare professionals who care for patients at risk for hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP), including specialists in infectious diseases, pulmonary diseases, critical care, and surgeons, anesthesiologists, hospitalists, and any clinicians and healthcare providers caring for hospitalized patients with nosocomial pneumonia. The panel's recommendations for the diagnosis and treatment of HAP and VAP are based upon evidence derived from topic-specific systematic literature reviews.

  20. Management of Adults With Hospital-acquired and Ventilator-associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society

    PubMed Central

    Kalil, Andre C.; Metersky, Mark L.; Klompas, Michael; Muscedere, John; Sweeney, Daniel A.; Palmer, Lucy B.; Napolitano, Lena M.; O'Grady, Naomi P.; Bartlett, John G.; Carratalà, Jordi; El Solh, Ali A.; Ewig, Santiago; Fey, Paul D.; File, Thomas M.; Restrepo, Marcos I.; Roberts, Jason A.; Waterer, Grant W.; Cruse, Peggy; Knight, Shandra L.; Brozek, Jan L.

    2016-01-01

    It is important to realize that guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations. IDSA considers adherence to these guidelines to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient's individual circumstances. These guidelines are intended for use by healthcare professionals who care for patients at risk for hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP), including specialists in infectious diseases, pulmonary diseases, critical care, and surgeons, anesthesiologists, hospitalists, and any clinicians and healthcare providers caring for hospitalized patients with nosocomial pneumonia. The panel's recommendations for the diagnosis and treatment of HAP and VAP are based upon evidence derived from topic-specific systematic literature reviews. PMID:27418577

  1. Pediatric gastroesophageal reflux clinical practice guidelines: joint recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN).

    PubMed

    Vandenplas, Yvan; Rudolph, Colin D; Di Lorenzo, Carlo; Hassall, Eric; Liptak, Gregory; Mazur, Lynnette; Sondheimer, Judith; Staiano, Annamaria; Thomson, Michael; Veereman-Wauters, Gigi; Wenzl, Tobias G; North American Society for Pediatric Gastroenterology Hepatology and Nutrition; European Society for Pediatric Gastroenterology Hepatology and Nutrition

    2009-10-01

    To develop a North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) international consensus on the diagnosis and management of gastroesophageal reflux and gastroesophageal reflux disease in the pediatric population. An international panel of 9 pediatric gastroenterologists and 2 epidemiologists were selected by both societies, which developed these guidelines based on the Delphi principle. Statements were based on systematic literature searches using the best-available evidence from PubMed, Cumulative Index to Nursing and Allied Health Literature, and bibliographies. The committee convened in face-to-face meetings 3 times. Consensus was achieved for all recommendations through nominal group technique, a structured, quantitative method. Articles were evaluated using the Oxford Centre for Evidence-based Medicine Levels of Evidence. Using the Oxford Grades of Recommendation, the quality of evidence of each of the recommendations made by the committee was determined and is summarized in appendices. More than 600 articles were reviewed for this work. The document provides evidence-based guidelines for the diagnosis and management of gastroesophageal reflux and gastroesophageal reflux disease in the pediatric population. This document is intended to be used in daily practice for the development of future clinical practice guidelines and as a basis for clinical trials.

  2. Systemic Therapy in Men With Metastatic Castration-Resistant Prostate Cancer: American Society of Clinical Oncology and Cancer Care Ontario Clinical Practice Guideline

    PubMed Central

    Basch, Ethan; Loblaw, D. Andrew; Oliver, Thomas K.; Carducci, Michael; Chen, Ronald C.; Frame, James N.; Garrels, Kristina; Hotte, Sebastien; Kattan, Michael W.; Raghavan, Derek; Saad, Fred; Taplin, Mary-Ellen; Walker-Dilks, Cindy; Williams, James; Winquist, Eric; Bennett, Charles L.; Wootton, Ted; Rumble, R. Bryan; Dusetzina, Stacie B.; Virgo, Katherine S.

    2014-01-01

    Purpose To provide treatment recommendations for men with metastatic castration-resistant prostate cancer (CRPC). Methods The American Society of Clinical Oncology and Cancer Care Ontario convened an expert panel to develop evidence-based recommendations informed by a systematic review of the literature. Results When added to androgen deprivation, therapies demonstrating improved survival, improved quality of life (QOL), and favorable benefit-harm balance include abiraterone acetate/prednisone, enzalutamide, and radium-223 (223Ra; for men with predominantly bone metastases). Improved survival and QOL with moderate toxicity risk are associated with docetaxel/prednisone. For asymptomatic/minimally symptomatic men, improved survival with unclear QOL impact and low toxicity are associated with sipuleucel-T. For men who previously received docetaxel, improved survival, unclear QOL impact, and moderate to high toxicity risk are associated with cabazitaxel/prednisone. Modest QOL benefit (without survival benefit) and high toxicity risk are associated with mitoxantrone/prednisone after docetaxel. No benefit and excess toxicity are observed with bevacizumab, estramustine, and sunitinib. Recommendations Continue androgen deprivation (pharmaceutical or surgical) indefinitely. Abiraterone acetate/prednisone, enzalutamide, or 223Ra should be offered; docetaxel/prednisone should also be offered, accompanied by discussion of toxicity risk. Sipuleucel-T may be offered to asymptomatic/minimally symptomatic men. For men who have experienced progression with docetaxel, cabazitaxel may be offered, accompanied by discussion of toxicity risk. Mitoxantrone may be offered, accompanied by discussion of limited clinical benefit and toxicity risk. Ketoconazole or antiandrogens (eg, bicalutamide, flutamide, nilutamide) may be offered, accompanied by discussion of limited known clinical benefit. Bevacizumab, estramustine, and sunitinib should not be offered. There is insufficient evidence to

  3. 2011 Focused Update of 2009 American Society of Clinical Oncology Clinical Practice Guideline Update on Chemotherapy for Stage IV Non–Small-Cell Lung Cancer

    PubMed Central

    Azzoli, Christopher G.; Temin, Sarah; Aliff, Timothy; Baker, Sherman; Brahmer, Julie; Johnson, David H.; Laskin, Janessa L.; Masters, Gregory; Milton, Daniel; Nordquist, Luke; Pao, William; Pfister, David G.; Piantadosi, Steven; Schiller, Joan H.; Smith, Reily; Smith, Thomas J.; Strawn, John R.; Trent, David; Giaccone, Giuseppe

    2011-01-01

    Purpose An American Society of Clinical Oncology (ASCO) focused update updates a single recommendation (or subset of recommendations) in advance of a regularly scheduled guideline update. This document updates one recommendation of the ASCO Guideline Update on Chemotherapy for Stage IV Non–Small-Cell Lung Cancer (NSCLC) regarding switch maintenance chemotherapy. Clinical Context Recent results from phase III clinical trials have demonstrated that in patients with stage IV NSCLC who have received four cycles of first-line chemotherapy and whose disease has not progressed, an immediate switch to alternative, single-agent chemotherapy can extend progression-free survival and, in some cases, overall survival. Because of limitations in the data, delayed treatment with a second-line agent after disease progression is also acceptable. Recent Data Seven randomized controlled trials of carboxyaminoimidazole, docetaxel, erlotinib, gefitinib, gemcitabine, and pemetrexed have evaluated outcomes in patients who received an immediate, non–cross resistant alternative therapy (switch maintenance) after first-line therapy. Recommendation In patients with stage IV NSCLC, first-line cytotoxic chemotherapy should be stopped at disease progression or after four cycles in patients whose disease is stable but not responding to treatment. Two-drug cytotoxic combinations should be administered for no more than six cycles. For those with stable disease or response after four cycles, immediate treatment with an alternative, single-agent chemotherapy such as pemetrexed in patients with nonsquamous histology, docetaxel in unselected patients, or erlotinib in unselected patients may be considered. Limitations of this data are such that a break from cytotoxic chemotherapy after a fixed course is also acceptable, with initiation of second-line chemotherapy at disease progression. PMID:21900105

  4. Screening, assessment, and management of fatigue in adult survivors of cancer: an American Society of Clinical oncology clinical practice guideline adaptation.

    PubMed

    Bower, Julienne E; Bak, Kate; Berger, Ann; Breitbart, William; Escalante, Carmelita P; Ganz, Patricia A; Schnipper, Hester Hill; Lacchetti, Christina; Ligibel, Jennifer A; Lyman, Gary H; Ogaily, Mohammed S; Pirl, William F; Jacobsen, Paul B

    2014-06-10

    This guideline presents screening, assessment, and treatment approaches for the management of adult cancer survivors who are experiencing symptoms of fatigue after completion of primary treatment. A systematic search of clinical practice guideline databases, guideline developer Web sites, and published health literature identified the pan-Canadian guideline on screening, assessment, and care of cancer-related fatigue in adults with cancer, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines In Oncology (NCCN Guidelines) for Cancer-Related Fatigue and the NCCN Guidelines for Survivorship. These three guidelines were appraised and selected for adaptation. It is recommended that all patients with cancer be evaluated for the presence of fatigue after completion of primary treatment and be offered specific information and strategies for fatigue management. For those who report moderate to severe fatigue, comprehensive assessment should be conducted, and medical and treatable contributing factors should be addressed. In terms of treatment strategies, evidence indicates that physical activity interventions, psychosocial interventions, and mind-body interventions may reduce cancer-related fatigue in post-treatment patients. There is limited evidence for use of psychostimulants in the management of fatigue in patients who are disease free after active treatment. Fatigue is prevalent in cancer survivors and often causes significant disruption in functioning and quality of life. Regular screening, assessment, and education and appropriate treatment of fatigue are important in managing this distressing symptom. Given the multiple factors contributing to post-treatment fatigue, interventions should be tailored to each patient's specific needs. In particular, a number of nonpharmacologic treatment approaches have demonstrated efficacy in cancer survivors. © 2014 by American Society of Clinical Oncology.

  5. Chronic kidney disease certification process manual by the Italian Society of Nephrology (SIN): part II: programme management and clinical information management.

    PubMed

    Quintaliani, Giuseppe; Cappelli, Gianni; Lodetti, Laura; Manno, Corrado; Petrucci, Virgilio; Spinelli, Cosimo; Tarchini, Renzo; Virgilio, Michele; Faini, Mario; Alloatti, Sandro; Cancarini, Giovanni; Zoccali, Carmine

    2009-01-01

    This is the second part of a document describing a voluntary certification process based on Joint Commission International (JCI) criteria developed by the Italian Society of Nephrology (SIN) and JCI representatives. In the first part we discussed standards for clinical care delivery and performance measurements related to chronic kidney disease care. Herein (Part II), we complete the description of Performace measurements and CKD care by describing issues related the management and clinical information management.

  6. What Clinical Changes Can We Expect in the Next 5 Years? A Review of the 26th International Congress of The Transplantation Society.

    PubMed

    Gill, John S

    2016-12-01

    Scientific presentations at the 26th International Congress of The Transplantation Society held in Hong Kong from August 18 to 23, 2016, highlighted accomplishments, challenges and opportunities in contemporary clinical organ transplantation. With nearly 1600 original abstract submissions, this review summarizes notable presentations in addressing a diversity of issues including deceased and living organ donation, improving allograft survival and unmet clinical needs in organ transplantation.

  7. [Joint recomendations for clinical priority in arterial surgery from Portuguese Society of Cardiothoracic and Vascular Surgery and Portuguese Society of Cardiology].

    PubMed

    Rocha-Neves, João; Ramos, José; Vieira, Mário; Neto, Marina; de Albuquerque, R; Dinis da Gama, A; Teixeira, José Fernando

    2014-01-01

    There is a gap in international guidelines for acceptable wait times for cardiovascular surgery. Most patients benefit from surgery as fast as possible after the establishment of an indication. However, due to extrinsic factors a continuous and cost-effective response is not feasible to all of them. Priority criteria for surgery after the indication is heterogeneous. The physician/surgeon is responsible for the surgical prioritization upon experience-based criteria. The prioritization is accepted by the hospitals most of the times, but incorrections are verified in excess and defect. There is a press in need for evidence-based prioritization criteria in cardiac and vascular surgery that maintains an adequate waiting time with maximum benefit. Surgical waiting times superior to what is clinically reasonable affects not only the patient but also the health system by indirect costs (morbidity, absence from work). The objective is to establish recommendations in extra- carotid disease, abdominal aortic disease, peripheral artery disease and vascular access construction. A review from the data is made to define an appropriate balance between the surgical scheduling and the prevention of pre an perioperatory adverse events.

  8. [Neurophysiological monitoring options in brain tumour resections. Consensus statement from the Spanish Society of Neurosurgery's (SENEC) Neuro-oncology Working Group and the Spanish Society of Clinical Neurophysiology (SENFC)].

    PubMed

    de Quintana-Schmidt, Cristian; Lladó-Carbo, Estela; Cortés-Doñate, Victoria Eugenia

    2017-10-05

    Brain tumours located in or in proximity to eloquent areas are a significant neurosurgical challenge. Performing this kind of surgery with neurophysiological monitoring to improve resections with reduced permanent focal neurological deficit has become widely accepted in the literature. However, how to conduct this monitoring, the exact definition of an eloquent area and whether to perform this surgery with the patient awake or asleep are still subject to rigorous scientific debate. Members of the Neuro-oncology Working Group (GTNO) of the Spanish Society of Neurosurgery (SENEC) and members of the Spanish Society of Clinical Neurophysiology (SENFC) have published a consensus statement to explain the different neurophysiological monitoring options currently available in awake and asleep patients to obtain better surgical resection without neurological deficits. An exhaustive review of the literature has also been conducted. Copyright © 2017 Sociedad Española de Neurocirugía. Publicado por Elsevier España, S.L.U. All rights reserved.

  9. Clinical Cancer Advances 2005: major research advances in cancer treatment, prevention, and screening--a report from the American Society of Clinical Oncology.

    PubMed

    Herbst, Roy S; Bajorin, Dean F; Bleiberg, Harry; Blum, Diane; Hao, Desirée; Johnson, Bruce E; Ozols, Robert F; Demetri, George D; Ganz, Patricia A; Kris, Mark G; Levin, Bernard; Markman, Maurie; Raghavan, Derek; Reaman, Gregory H; Sawaya, Raymond; Schuchter, Lynn M; Sweetenham, John W; Vahdat, Linda T; Vokes, Everett E; Winn, Rodger J; Mayer, Robert J

    2006-01-01

    This year, for the first time, the American Society of Clinical Oncology (ASCO) is publishing Clinical Cancer Advances 2005: Major Research Advances in Cancer Treatment, Prevention, and Screening, an annual review of the most significant clinical research presented or published over the past year across all cancer types. ASCO embarked on this project to provide the public, patients, policymakers, and physicians with an accessible summary of the year's most important research advances. While not intended to serve as a comprehensive review, this report provides a year-end snapshot of research that will have the greatest impact on patient care. As you will read, there is much good news from the front lines of cancer research. These pages report on new chemotherapy regimens that sharply reduce the risk of recurrence for very common cancers; the "coming of age" of targeted cancer therapies; promising studies of drugs to prevent cancer; and improvements in quality of life for people living with the disease, among many other advances. Survival rates for cancer are on the rise, increasing from 50% to 64% over the last 30 years. Cancer still exacts an enormous toll, however. Nearly 1.4 million Americans will be diagnosed this year, and some 570,000 will die of the disease. Clearly, more research is needed to find effective therapies for the most stubborn cancer types and stages. We need to know more about the long-term effects of newer, more targeted cancer therapies, some of which need to be taken over long periods of time. And we need to devote far greater attention to tracking and improving the care of the nearly 10 million cancer survivors in the United States today. Despite these and other challenges, the message of this report is one of hope. Through the dedicated, persistent pursuit of clinical research and participation in clinical trials by people with cancer, we steadily uncover new and better ways of treating, diagnosing, and preventing a disease that touches the

  10. American Society of Clinical Oncology provisional clinical opinion: chronic hepatitis B virus infection screening in patients receiving cytotoxic chemotherapy for treatment of malignant diseases.

    PubMed

    Artz, Andrew S; Somerfield, Mark R; Feld, Jordan J; Giusti, Andrew F; Kramer, Barnett S; Sabichi, Anita L; Zon, Robin T; Wong, Sandra L

    2010-07-01

    PURPOSE An American Society of Clinical Oncology (ASCO) provisional clinical opinion (PCO) offers timely clinical direction to ASCO's membership following publication or presentation of potentially practice-changing information. This PCO addresses recommendations for chronic hepatitis B virus (HBV) infection screening in patients receiving cytotoxic or immunosuppressive chemotherapy for treatment of malignant diseases. The Centers for Disease Control and Prevention (CDC) issued Recommendations for Identification and Public Health Management of Persons with Chronic Hepatitis B Virus Infection, recommending screening for hepatitis B infection (hepatitis B surface antigen [HBsAg], antihepatitis B core antigen [anti-HBc], and antibodies to HBsAg [anti-HBs]) for "persons receiving cytotoxic or immunosuppressive therapy (eg, chemotherapy for malignant diseases...)." The evidence is insufficient to determine the net benefits and harms of routine screening for chronic HBV infection in individuals with cancer who are about to receive cytotoxic or immunosuppressive therapy or who are already receiving therapy. Individuals with cancer who undergo certain cytotoxic or immunosuppressive therapies and have HBV infection or prior exposure to HBV may be at elevated risk of liver failure from HBV reactivation. As such, HBV screening requires clinical judgment. Physicians may consider screening patients belonging to groups at heightened risk for chronic HBV infection or if highly immunosuppressive therapy is planned. Highly immunosuppressive treatments include, but are not limited to, hematopoietic cell transplantation and regimens including rituximab. Screening based on a high risk of prior HBV exposure or risk of reactivation due to planned therapeutic regimens should include testing for HBsAg as a serologic marker for HBV infection. In some populations, testing for anti-HBc should also be considered. There is no evidence to support serologic testing for anti-HBs in this context

  11. Essentials from the 2015 European AIDS Clinical Society (EACS) guidelines for the treatment of adult HIV-positive persons.

    PubMed

    Ryom, L; Boesecke, C; Gisler, V; Manzardo, C; Rockstroh, J K; Puoti, M; Furrer, H; Miro, J M; Gatell, J M; Pozniak, A; Behrens, G; Battegay, M; Lundgren, J D

    2016-02-01

    The European AIDS Clinical Society (EACS) guidelines are intended for all clinicians involved in the care of HIV-positive persons, and are available in print, online, and as a free App for download for iPhone and Android. The 2015 version of the EACS guidelines contains major revisions in all sections; antiretroviral treatment (ART), comorbidities, coinfections and opportunistic diseases. Among the key revisions is the recommendation of ART for all HIV-positive persons, irrespectively of CD4 count, based on the Strategic Timing of AntiRetroviral Treatment (START) study results. The recommendations for the preferred and the alternative ART options have also been revised, and a new section on the use of pre-exposure prophylaxis (PrEP) has been added. A number of new antiretroviral drugs/drug combinations have been added to the updated tables on drug-drug interactions, adverse drug effects, dose adjustment for renal/liver insufficiency and for ART administration in persons with swallowing difficulties. The revisions of the coinfection section reflect the major advances in anti-hepatitis C virus (HCV) treatment with direct-acting antivirals with earlier start of treatment in individuals at increased risk of liver disease progression, and a phasing out of interferon-containing treatment regimens. The section on opportunistic diseases has been restructured according to individual pathogens/diseases and a new overview table has been added on CD4 count thresholds for different primary prophylaxes. The diagnosis and management of HIV infection and related coinfections, opportunistic diseases and comorbidities continue to require a multidisciplinary effort for which the 2015 version of the EACS guidelines provides an easily accessable and updated overview. © 2015 British HIV Association.

  12. What is the quality of information on social oocyte cryopreservation provided by websites of Society for Assisted Reproductive Technology member fertility clinics?

    PubMed

    Avraham, Sarit; Machtinger, Ronit; Cahan, Tal; Sokolov, Amit; Racowsky, Catherine; Seidman, Daniel S

    2014-01-01

    To evaluate adequacy and adherence to American Society for Reproductive Medicine (ASRM) guidelines of internet information provided by Society for Assisted Reproductive Technology (SART)-affiliated clinics regarding social oocyte cryopreservation (SOC). Systematic evaluation of websites of all SART member fertility clinics. The internet. None. All websites offering SOC services were scored using a 0-13 scale, based on 10 questions designed to assess website quality and adherence to the ASRM/SART guidelines. The websites were analyzed independently by two authors. Whenever disagreement occurred, a third investigator determined the score. Scores defined website quality as excellent, ≥9; moderate, 5-8; or poor, ≤4 points. Of the 387 clinics registered as SART members, 200 offered oocyte cryopreservation services for either medical or social reasons; 147 of these advertised SOC. The average website scores of those clinics offering SOC was 3.4 ± 2.1 (range, 2-11) points. There was no significant difference in scores between private versus academic clinics or clinics performing more or less than 500 cycles per year. The majority of the websites do not follow the SART/ASRM guidelines for SOC, indicating that there is a need to improve the type and quality of information provided on SOC by SART member websites. Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  13. [Consensus on the detection and management of prediabetes. Consensus and Clinical Guidelines Working Group of the Spanish Diabetes Society].

    PubMed

    Mata-Cases, M; Artola, S; Escalada, J; Ezkurra-Loyola, P; Ferrer-García, J C; Fornos, J A; Girbés, J; Rica, I

    2015-03-01

    In Spain, according to the Di@bet.es study, 13.8% of the adult population suffers from diabetes and 14.8% from some form of prediabetes (impaired glucose tolerance, impaired fasting glucose or both). Since early detection of prediabetes can facilitate the implementation of therapeutic measures to prevent its progression to diabetes, we believe that preventive strategies in primary care and specialized clinical settings should be agreed. Screening for diabetes and prediabetes using a specific questionnaire (FINDRISC) and/or the measurement of fasting plasma glucose in high risk patients leads to detecting patients at risk of developing diabetes and it is necessary to consider how they should be managed. The intervention in lifestyle can reduce the progression to diabetes and reverse a prediabetic state to normal and is a cost-effective intervention. Some drugs, such as metformin, have also been shown effective in reducing the progression to diabetes but are not superior to non-pharmacological interventions. Finally, an improvement in some cardiovascular risk factors has been observed although there is no strong evidence supporting the effectiveness of screening in terms of morbility and mortality. The Consensus and Clinical Guidelines Working Group of the Spanish Diabetes Society has issued some recommendations that have been agreed by the Sociedad Española de Endocrinología y Nutrición, Sociedad Española de Endocrinología Pediátrica, Sociedad Española de Farmacia Comunitaria, Sociedad Española de Medicina Familiar y Comunitaria, Sociedad Española de Médicos Generales, Sociedad Española de Médicos de Atención Primaria, Sociedad Española de Medicina Interna, Asociación de Enfermería Comunitaria and Red de Grupos de Estudio de la Diabetes en Atención Primaria. Copyright © 2014 SEEN. Published by Elsevier España, S.L.U. All rights reserved.

  14. [Consensus on the detection and management of prediabetes. Consensus and Clinical Guidelines Working Group of the Spanish Diabetes Society].

    PubMed

    Mata-Cases, M; Artola, S; Escalada, J; Ezkurra-Loyola, P; Ferrer-García, J C; Fornos, J A; Girbés, J; Rica, I

    2015-01-01

    In Spain, according to the Di@bet.es study, 13.8% of the adult population suffers from diabetes and 14.8% from some form of prediabetes (impaired glucose tolerance, impaired fasting glucose or both). Since early detection of prediabetes can facilitate the implementation of therapeutic measures to prevent its progression to diabetes, we believe that preventive strategies in primary care and specialized clinical settings should be agreed. Screening for diabetes and prediabetes using a specific questionnaire (FINDRISC) and/or the measurement of fasting plasma glucose in high risk patients leads to detecting patients at risk of developing diabetes and it is necessary to consider how they should be managed. The intervention in lifestyle can reduce the progression to diabetes and reverse a prediabetic state to normal and is a cost-effective intervention. Some drugs, such as metformin, have also been shown effective in reducing the progression to diabetes but are not superior to non-pharmacological interventions. Finally, an improvement in some cardiovascular risk factors has been observed although there is no strong evidence supporting the effectiveness of screening in terms of morbility and mortality. The Consensus and Clinical Guidelines Working Group of the Spanish Diabetes Society has issued some recommendations that have been agreed by the Sociedad Española de Endocrinología y Nutrición, Sociedad Española de Endocrinología Pediátrica, Sociedad Española de Farmacia Comunitaria, Sociedad Española de Medicina Familiar y Comunitaria, Sociedad Española de Médicos Generales, Sociedad Española de Médicos de Atención Primaria, Sociedad Española de Medicina Interna, Asociación de Enfermería Comunitaria and Red de Grupos de Estudio de la Diabetes en Atención Primaria. Copyright © 2014 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España, S.L.U. All rights reserved.

  15. A critical review of the American Pain Society clinical practice guidelines for interventional techniques: part 2. Therapeutic interventions.

    PubMed

    Manchikanti, Laxmaiah; Datta, Sukdeb; Gupta, Sanjeeva; Munglani, Rajesh; Bryce, David A; Ward, Stephen P; Benyamin, Ramsin M; Sharma, Manohar Lal; Helm, Standiford; Fellows, Bert; Hirsch, Joshua A

    2010-01-01

    Clinical guidelines are a constructive response to the reality that practicing physicians require assistance in assimilating and applying the exponentially expanding, often contradictory, body of medical knowledge. They attempt to define practices that meet the needs of most patients under most circumstances. Ideally, specific clinical recommendations contained within practice guidelines are systematically developed by expert panels who have access to all the available evidence, have an understanding of the clinical problem, and have clinical experience with the procedure being assessed, as well as knowledge of relevant research methods. The recent development of American Pain Society (APS) guidelines has created substantial controversy because of their perceived lack of objective analysis and recommendations perceived to be biased due to conflicts of interest. To formally and carefully assess the APS guidelines' evidence synthesis for low back pain for therapeutic interventions using the same methodology utilized by the APS authors. The interventions examined were therapeutic interventions for managing low back pain, including epidural injections, adhesiolysis, facet joint interventions, and spinal cord stimulation. A literature search by 2 authors was carried out utilizing appropriate databases from 1966 through July 2008. Articles in which conflicts arose were reviewed and mediated by a third author to arrive at a consensus. Selections of manuscripts and methodologic quality assessment was also performed by at least 2 authors utilizing the same criteria applied in the APS guidelines. The guideline reassessment process included the evaluation of individual studies and systematic reviews and their translation into practice recommendations. The conclusions of APS and our critical assessment based on grading of good, fair, and poor, agreed that there is fair evidence for spinal cord stimulation in post lumbar surgery syndrome, and poor evidence for lumbar

  16. Clinical cancer advances 2006: major research advances in cancer treatment, prevention, and screening--a report from the American Society of Clinical Oncology.

    PubMed

    Ozols, Robert F; Herbst, Roy S; Colson, Yolonda L; Gralow, Julie; Bonner, James; Curran, Walter J; Eisenberg, Burton L; Ganz, Patricia A; Kramer, Barnett S; Kris, Mark G; Markman, Maurie; Mayer, Robert J; Raghavan, Derek; Reaman, Gregory H; Sawaya, Raymond; Schilsky, Richard L; Schuchter, Lynn M; Sweetenham, John W; Vahdat, Linda T; Winn, Rodger J

    2007-01-01

    A MESSAGE FROM ASCO's PRESIDENT For the second consecutive year, the American Society of Clinical Oncology (ASCO) is publishing Clinical Cancer Advances: Major Research Advances in Cancer Treatment, Prevention, and Screening, an annual review of the most significant cancer research presented or published over the past year. ASCO developed this report to demonstrate the enormous progress being made on the front lines of cancer research today. The report is intended to give all those with an interest in cancer care-the general public, cancer patients and physicians, policymakers, oncologists, and other medical professionals-an accessible summary of the year's most important cancer research advances. These pages report on new targeted therapies that are improving survival and response rates in hard-to-treat cancers such as kidney cancer, HER-2-positive breast cancer, head and neck cancer, and chronic myelogenous leukemia; the FDA's approval of the world's first preventive vaccine for human papillomavirus (HPV), which has the potential to dramatically reduce the global burden of cervical cancer; and advances in the fast-growing field of personalized medicine, including a new lung cancer test that could help physicians better target treatments and predict prognosis. These advances are only part of the landscape. Survival rates are on the rise, the number of cancer deaths in the United States began declining for the first time since 1930, and new research is showing that the rates of certain common cancers, such as those of the breast and colon, have stabilized, and may have even begun to decline. However, cancer research still faces a number of major obstacles. At a time of extraordinary scientific potential, declining federal funding of cancer research threatens to stall or even reverse recent progress. Such funding cuts have already led to fewer clinical trials, fewer talented young physicians entering the field, and a growing bottleneck of basic science discoveries

  17. Nationwide surveillance of bacterial respiratory pathogens conducted by the surveillance committee of Japanese Society of Chemotherapy, the Japanese Association for Infectious Diseases, and the Japanese Society for Clinical Microbiology in 2010: General view of the pathogens' antibacterial susceptibility.

    PubMed

    Yanagihara, Katsunori; Kadota, Junichi; Aoki, Nobuki; Matsumoto, Tetsuya; Yoshida, Masaki; Yagisawa, Morimasa; Oguri, Toyoko; Sato, Junko; Ogasawara, Kazuhiko; Wakamura, Tomotaro; Sunakawa, Keisuke; Watanabe, Akira; Iwata, Satoshi; Kaku, Mitsuo; Hanaki, Hideaki; Ohsaki, Yoshinobu; Watari, Tomohisa; Toyoshima, Eri; Takeuchi, Kenichi; Shiokoshi, Mayumi; Takeda, Hiroaki; Miki, Makoto; Kumagai, Toshio; Nakanowatari, Susumu; Takahashi, Hiroshi; Utagawa, Mutsuko; Nishiya, Hajime; Kawakami, Sayoko; Kobayashi, Nobuyuki; Takasaki, Jin; Mezaki, Kazuhisa; Konosaki, Hisami; Aoki, Yasuko; Yamamoto, Yumiko; Shoji, Michi; Goto, Hajime; Saraya, Takeshi; Kurai, Daisuke; Okazaki, Mitsuhiro; Niki, Yoshihito; Yoshida, Koichiro; Kawana, Akihiko; Saionji, Katsu; Fujikura, Yuji; Miyazawa, Naoki; Kudo, Makoto; Sato, Yoshimi; Yamamoto, Masaki; Yoshida, Takashi; Nakamura, Masahiko; Tsukada, Hiroki; Imai, Yumiko; Tsukada, Ayami; Kawasaki, Satoshi; Honma, Yasuo; Yamamoto, Toshinobu; Ban, Nobuyoshi; Mikamo, Hiroshige; Sawamura, Haruki; Miyara, Takayuki; Toda, Hirofumi; Sato, Kaori; Nakamura, Tadahiro; Fujikawa, Yasunori; Mitsuno, Noriko; Mikasa, Keiichi; Kasahara, Kei; Sano, Reiko; Sugimoto, Keisuke; Asari, Seishi; Nishi, Isao; Toyokawa, Masahiro; Miyashita, Naoyuki; Koguchi, Yutaka; Kusano, Nobuchika; Mihara, Eiichirou; Kuwabara, Masao; Watanabe, Yaeko; Kawasaki, Yuji; Takeda, Kenichi; Tokuyasu, Hirokazu; Masui, Kayoko; Negayama, Kiyoshi; Hiramatsu, Kazufumi; Aoki, Yosuke; Fukuoka, Mami; Magarifuchi, Hiroki; Nagasawa, Zenzo; Suga, Moritaka; Muranaka, Hiroyuki; Morinaga, Yoshitomo; Honda, Junichi; Fujita, Masaki

    2015-06-01

    The nationwide surveillance on antimicrobial susceptibility of bacterial respiratory pathogens from patients in Japan, was conducted by Japanese Society of Chemotherapy, Japanese Association for Infectious Diseases and Japanese Society for Clinical Microbiology in 2010. The isolates were collected from clinical specimens obtained from well-diagnosed adult patients with respiratory tract infections during the period from January and April 2010 by three societies. Antimicrobial susceptibility testing was conducted at the central reference laboratory according to the method recommended by Clinical and Laboratory Standard Institutes using maximum 45 antibacterial agents. Susceptibility testing was evaluable with 954 strains (206 Staphylococcus aureus, 189 Streptococcus pneumoniae, 4 Streptococcus pyogenes, 182 Haemophilus influenzae, 74 Moraxella catarrhalis, 139 Klebsiella pneumoniae and 160 Pseudomonas aeruginosa). Ratio of methicillin-resistant S. aureus was as high as 50.5%, and those of penicillin-intermediate and -resistant S. pneumoniae were 1.1% and 0.0%, respectively. Among H. influenzae, 17.6% of them were found to be β-lactamase-non-producing ampicillin (ABPC)-intermediately resistant, 33.5% to be β-lactamase-non-producing ABPC-resistant and 11.0% to be β-lactamase-producing ABPC-resistant strains. Extended spectrum β-lactamase-producing K. pneumoniae and multi-drug resistant P. aeruginosa with metallo β-lactamase were 2.9% and 0.6%, respectively. Continuous national surveillance of antimicrobial susceptibility of respiratory pathogens is crucial in order to monitor changing patterns of susceptibility and to be able to update treatment recommendations on a regular basis.

  18. Use of 5-α-Reductase Inhibitors for Prostate Cancer Chemoprevention: American Society of Clinical Oncology/American Urological Association 2008 Clinical Practice Guideline

    PubMed Central

    Kramer, Barnett S.; Hagerty, Karen L.; Justman, Stewart; Somerfield, Mark R.; Albertsen, Peter C.; Blot, William J.; Ballentine Carter, H.; Costantino, Joseph P.; Epstein, Jonathan I.; Godley, Paul A.; Harris, Russell P.; Wilt, Timothy J.; Wittes, Janet; Zon, Robin; Schellhammer, Paul

    2009-01-01

    Purpose To develop an evidence-based guideline on the use of 5-α-reductase inhibitors (5-ARIs) for prostate cancer chemoprevention. Methods The American Society of Clinical Oncology (ASCO) Health Services Committee (HSC), ASCO Cancer Prevention Committee, and the American Urological Association Practice Guidelines Committee jointly convened a Panel of experts, who used the results from a systematic review of the literature to develop evidence-based recommendations on the use of 5-ARIs for prostate cancer chemoprevention. Results The systematic review completed for this guideline identified 15 randomized clinical trials that met the inclusion criteria, nine of which reported prostate cancer period prevalence. Conclusion Asymptomatic men with a prostate-specific antigen (PSA) ≤ 3.0 ng/mL who are regularly screened with PSA or are anticipating undergoing annual PSA screening for early detection of prostate cancer may benefit from a discussion of both the benefits of 5-ARIs for 7 years for the prevention of prostate cancer and the potential risks (including the possibility of high-grade prostate cancer). Men who are taking 5-ARIs for benign conditions such as lower urinary tract [obstructive] symptoms (LUTS) may benefit from a similar discussion, understanding that the improvement of LUTS relief should be weighed with the potential risks of high-grade prostate cancer from 5-ARIs (although the majority of the Panel members judged the latter risk to be unlikely). A reduction of approximately 50% in PSA by 12 months is expected in men taking a 5-ARI; however, because these changes in PSA may vary across men, and within individual men over time, the Panel cannot recommend a specific cut point to trigger a biopsy for men taking a 5-ARI. No specific cut point or change in PSA has been prospectively validated in men taking a 5-ARI. PMID:19252137

  19. American Society of Clinical Oncology Clinical Practice Guideline Update on the Use of Pharmacologic Interventions Including Tamoxifen, Raloxifene, and Aromatase Inhibition for Breast Cancer Risk Reduction

    PubMed Central

    Visvanathan, Kala; Chlebowski, Rowan T.; Hurley, Patricia; Col, Nananda F.; Ropka, Mary; Collyar, Deborah; Morrow, Monica; Runowicz, Carolyn; Pritchard, Kathleen I.; Hagerty, Karen; Arun, Banu; Garber, Judy; Vogel, Victor G.; Wade, James L.; Brown, Powel; Cuzick, Jack; Kramer, Barnett S.; Lippman, Scott M.

    2009-01-01

    Purpose To update the 2002 American Society of Clinical Oncology guideline on pharmacologic interventions for breast cancer (BC) risk reduction. Methods A literature search identified relevant randomized trials published since 2002. Primary outcome of interest was BC incidence (invasive and noninvasive). Secondary outcomes included BC mortality, adverse events, and net health benefits. An expert panel reviewed the literature and developed updated consensus guidelines. Results Seventeen articles met inclusion criteria. In premenopausal women, tamoxifen for 5 years reduces the risk of BC for at least 10 years, particularly estrogen receptor (ER) –positive invasive tumors. Women ≤ 50 years of age experience fewer serious side effects. Vascular and vasomotor events do not persist post-treatment across all ages. In postmenopausal women, raloxifene and tamoxifen reduce the risk of ER-positive invasive BC with equal efficacy. Raloxifene is associated with a lower risk of thromboembolic disease, benign uterine conditions, and cataracts than tamoxifen in postmenopausal women. No evidence exists establishing whether a reduction in BC risk from either agent translates into reduced BC mortality. Recommendations In women at increased risk for BC, tamoxifen (20 mg/d for 5 years) may be offered to reduce the risk of invasive ER-positive BC, with benefits for at least 10 years. In postmenopausal women, raloxifene (60 mg/d for 5 years) may also be considered. Use of aromatase inhibitors, fenretinide, or other selective estrogen receptor modulators to lower BC risk is not recommended outside of a clinical trial. Discussion of risks and benefits of preventive agents by health providers is critical to patient decision making. PMID:19470930

  20. [Implementation of Guidelines on Conflict of Interest in Clinical Research of the Japanese Society of Psychiatry and Neurology: actual status and future perspectives].

    PubMed

    Mikuni, Masahiko; Kurihara, Chieko; Miyaoka, Hitoshi

    2014-01-01

    In May 2011, the Japanese Society of Psychiatry and Neurology released their Guidelines on Conflict of Interest (COI) in Clinical Research and detailed regulations. These guidelines cover clinical research, although each committee of the society may have a policy to cover basic research as well as clinical research. The COI Committee implemented the guidelines, including a one-year trial period. According to the guidelines, members of the society have to disclose their COIs at the time of presentations, manuscript submissions, and publications; the board and committees members have to submit their COIs to the president of the society. During the trial period, the latter was limited to the four committees involved in the development of the guidelines: Conflict of Interest; Pharmaceutical Affairs; Research Ethics; and Editorial Committees. The COI Committee reviewed the COIs submitted by the board and committee members. The COI Committee found that, among the 382 board and committee members, 298 were without COI; 31 COIs were regarded by one committee member as not necessary to be circulated to all the attending members (total of these 2 categories: 329, 87%); 31 COIs (8%) were regarded as necessary to be circulated; and 18 cases (4.7%) were problematic: not submitted or explicit rejection of submission. Considering the seriousness of scientific misconduct by a researcher in another disease area who resigned his professorship and is now under investigation, we should further discuss the implementation of our COI guidelines.

  1. Clinical Cancer Advances 2008: Major Research Advances in Cancer Treatment, Prevention, and Screening—A Report From the American Society of Clinical Oncology

    PubMed Central

    Winer, Eric; Gralow, Julie; Diller, Lisa; Karlan, Beth; Loehrer, Patrick; Pierce, Lori; Demetri, George; Ganz, Patricia; Kramer, Barnett; Kris, Mark; Markman, Maurie; Mayer, Robert; Pfister, David; Raghavan, Derek; Ramsey, Scott; Reaman, Gregory; Sandler, Howard; Sawaya, Raymond; Schuchter, Lynn; Sweetenham, John; Vahdat, Linda; Schilsky, Richard L.

    2009-01-01

    most significant clinical research is conducted increasingly overseas. In addition, talented young physicians in the United States, seeing less opportunity in the field of oncology, are choosing other specialties instead. Although greater investment in research is critical, the need for new therapies is only part of the challenge. Far too many people in the United States lack access to the treatments that already exist, leading to unnecessary suffering and death. Uninsured cancer patients are significantly more likely to die than those with insurance, racial disparities in cancer incidence and mortality remain stark, and even insured patients struggle to keep up with the rapidly rising cost of cancer therapies. As this annual American Society of Clinical Oncology report of the major cancer research advances during the last year demonstrates, we are making important progress against cancer. But sound public policies are essential to accelerate that progress. In 2009, we have an opportunity to reinvest in cancer research, and to support policies that will help ensure that every individual in the United States receives potentially life-saving cancer prevention, early detection, and treatment. Sincerely, Richard L. Schilsky, MD President American Society of Clinical Oncology PMID:19103723

  2. Clinical cancer advances 2008: major research advances in cancer treatment, prevention, and screening--a report from the American Society of Clinical Oncology.

    PubMed

    Winer, Eric; Gralow, Julie; Diller, Lisa; Karlan, Beth; Loehrer, Patrick; Pierce, Lori; Demetri, George; Ganz, Patricia; Kramer, Barnett; Kris, Mark; Markman, Maurie; Mayer, Robert; Pfister, David; Raghavan, Derek; Ramsey, Scott; Reaman, Gregory; Sandler, Howard; Sawaya, Raymond; Schuchter, Lynn; Sweetenham, John; Vahdat, Linda; Schilsky, Richard L

    2009-02-10

    significant clinical research is conducted increasingly overseas. In addition, talented young physicians in the United States, seeing less opportunity in the field of oncology, are choosing other specialties instead. Although greater investment in research is critical, the need for new therapies is only part of the challenge. Far too many people in the United States lack access to the treatments that already exist, leading to unnecessary suffering and death. Uninsured cancer patients are significantly more likely to die than those with insurance, racial disparities in cancer incidence and mortality remain stark, and even insured patients struggle to keep up with the rapidly rising cost of cancer therapies. As this annual American Society of Clinical Oncology report of the major cancer research advances during the last year demonstrates, we are making important progress against cancer. But sound public policies are essential to accelerate that progress. In 2009, we have an opportunity to reinvest in cancer research, and to support policies that will help ensure that every individual in the United States receives potentially life-saving cancer prevention, early detection, and treatment. Sincerely, Richard L. Schilsky, MD President American Society of Clinical Oncology.

  3. Canadian Society of Nephrology commentary on the 2012 KDIGO clinical practice guideline for the management of blood pressure in CKD.

    PubMed

    Ruzicka, Marcel; Quinn, Robert R; McFarlane, Phil; Hemmelgarn, Brenda; Ramesh Prasad, G V; Feber, Janusz; Nesrallah, Gihad; MacKinnon, Martin; Tangri, Navdeep; McCormick, Brendan; Tobe, Sheldon; Blydt-Hansen, Tom D; Hiremath, Swapnil

    2014-06-01

    The KDIGO (Kidney Disease: Improving Global Outcomes) 2012 clinical practice guideline for the management of blood pressure (BP) in chronic kidney disease (CKD) provides the structural and evidence base for the Canadian Society of Nephrology (CSN) commentary on this guideline's relevancy and application to the Canadian health care system. While in general agreement, we provide commentary on 13 of the 21 KDIGO guideline statements. Specifically, we agreed that nonpharmacological interventions should play a significant role in the management of hypertension in patients with CKD. We also agreed that the approach to the management of hypertension in elderly patients with CKD should be individualized and take into account comorbid conditions to avoid adverse outcomes from excessive BP lowering. In contrast to KDIGO, the CSN Work Group believes there is insufficient evidence to target a lower BP for nondiabetic CKD patients based on the presence and severity of albuminuria. The CSN Work Group concurs with the Canadian Hypertension Education Program (CHEP) recommendation of a target BP for all non-dialysis-dependent CKD patients without diabetes of ≤140 mm Hg systolic and ≤90 mm Hg diastolic. Similarly, it is our position that in diabetic patients with CKD and normal urinary albumin excretion, raising the threshold for treatment from <130 mm Hg systolic BP to <140 mm Hg systolic BP could increase stroke risk and the risk of worsening kidney disease. The CSN Work Group concurs with the CHEP and the Canadian Diabetic Association recommendation for diabetic patients with CKD with or without albuminuria to continue to be treated to a BP target similar to that of the overall diabetes population, aiming for BP levels < 130/80 mm Hg. Consistent with this, the CSN Work Group endorses a BP target of <130/80 mm Hg for diabetic patients with a kidney transplant. Finally, in the absence of evidence for a lower BP target, the CSN Work Group concurs with the CHEP recommendation

  4. Canadian Cardiovascular Society Consensus Conference guidelines on heart failure, update 2009: diagnosis and management of right-sided heart failure, myocarditis, device therapy and recent important clinical trials.

    PubMed

    Howlett, Jonathan G; McKelvie, Robert S; Arnold, J Malcolm O; Costigan, Jeannine; Dorian, Paul; Ducharme, Anique; Estrella-Holder, Estrellita; Ezekowitz, Justin A; Giannetti, Nadia; Haddad, Haissam; Heckman, George A; Herd, Anthony M; Isaac, Debra; Jong, Philip; Kouz, Simon; Liu, Peter; Mann, Elizabeth; Moe, Gordon W; Tsuyuki, Ross T; Ross, Heather J; White, Michel

    2009-02-01

    The Canadian Cardiovascular Society published a comprehensive set of recommendations on the diagnosis and management of heart failure in January 2006. Based on feedback obtained through a national program of heart failure workshops and through active solicitation of stakeholders, several topics were identified because of their importance to the practicing clinician. Topics chosen for the present update include best practices for the diagnosis and management of right-sided heart failure, myocarditis and device therapy, and a review of recent important or landmark clinical trials. These recommendations were developed using the structured approach for the review and assessment of evidence adopted and previously described by the Society. The present update has been written from a clinical perspective to provide a user-friendly and practical approach. Specific clinical questions that are addressed include: What is right-sided heart failure and how should one approach the diagnostic work-up? What other clinical entities may masquerade as this nebulous condition and how can we tell them apart? When should we be concerned about the presence of myocarditis and how quickly should patients with this condition be referred to an experienced centre? Among the myriad of recently published landmark clinical trials, which ones will impact our standards of clinical care? The goals are to aid physicians and other health care providers to optimally treat heart failure patients, resulting in a measurable impact on patient health and clinical outcomes in Canada.

  5. Canadian Cardiovascular Society Consensus Conference guidelines on heart failure, update 2009: Diagnosis and management of right-sided heart failure, myocarditis, device therapy and recent important clinical trials

    PubMed Central

    Howlett, Jonathan G; McKelvie, Robert S; Arnold, J Malcolm O; Costigan, Jeannine; Dorian, Paul; Ducharme, Anique; Estrella-Holder, Estrellita; Ezekowitz, Justin A; Giannetti, Nadia; Haddad, Haissam; Heckman, George A; Herd, Anthony M; Isaac, Debra; Jong, Philip; Kouz, Simon; Liu, Peter; Mann, Elizabeth; Moe, Gordon W; Tsuyuki, Ross T; Ross, Heather J; White, Michel

    2009-01-01

    The Canadian Cardiovascular Society published a comprehensive set of recommendations on the diagnosis and management of heart failure in January 2006. Based on feedback obtained through a national program of heart failure workshops and through active solicitation of stakeholders, several topics were identified because of their importance to the practicing clinician. Topics chosen for the present update include best practices for the diagnosis and management of right-sided heart failure, myocarditis and device therapy, and a review of recent important or landmark clinical trials. These recommendations were developed using the structured approach for the review and assessment of evidence adopted and previously described by the Society. The present update has been written from a clinical perspective to provide a user-friendly and practical approach. Specific clinical questions that are addressed include: What is right-sided heart failure and how should one approach the diagnostic work-up? What other clinical entities may masquerade as this nebulous condition and how can we tell them apart? When should we be concerned about the presence of myocarditis and how quickly should patients with this condition be referred to an experienced centre? Among the myriad of recently published landmark clinical trials, which ones will impact our standards of clinical care? The goals are to aid physicians and other health care providers to optimally treat heart failure patients, resulting in a measurable impact on patient health and clinical outcomes in Canada. PMID:19214293

  6. Current issues in medically assisted reproduction and genetics in Europe: research, clinical practice, ethics, legal issues and policy. European Society of Human Genetics and European Society of Human Reproduction and Embryology.

    PubMed

    Harper, Joyce C; Geraedts, Joep; Borry, Pascal; Cornel, Martina C; Dondorp, Wybo; Gianaroli, Luca; Harton, Gary; Milachich, Tanya; Kääriäinen, Helena; Liebaers, Inge; Morris, Michael; Sequeiros, Jorge; Sermon, Karen; Shenfield, Françoise; Skirton, Heather; Soini, Sirpa; Spits, Claudia; Veiga, Anna; Vermeesch, Joris Robert; Viville, Stéphane; de Wert, Guido; Macek, Milan

    2013-11-01

    In March 2005, a group of experts from the European Society of Human Genetics and European Society of Human Reproduction and Embryology met to discuss the interface between genetics and assisted reproductive technology (ART), and published an extended background paper, recommendations and two Editorials. Seven years later, in March 2012, a follow-up interdisciplinary workshop was held, involving representatives of both professional societies, including experts from the European Union Eurogentest2 Coordination Action Project. The main goal of this meeting was to discuss developments at the interface between clinical genetics and ARTs. As more genetic causes of reproductive failure are now recognised and an increasing number of patients undergo testing of their genome before conception, either in regular health care or in the context of direct-to-consumer testing, the need for genetic counselling and preimplantation genetic diagnosis (PGD) may increase. Preimplantation genetic screening (PGS) thus far does not have evidence from randomised clinical trials to substantiate that the technique is both effective and efficient. Whole-genome sequencing may create greater challenges both in the technological and interpretational domains, and requires further reflection about the ethics of genetic testing in ART and PGD/PGS. Diagnostic laboratories should be reporting their results according to internationally accepted accreditation standards (International Standards Organisation - ISO 15189). Further studies are needed in order to address issues related to the impact of ART on epigenetic reprogramming of the early embryo. The legal landscape regarding assisted reproduction is evolving but still remains very heterogeneous and often contradictory. The lack of legal harmonisation and uneven access to infertility treatment and PGD/PGS fosters considerable cross-border reproductive care in Europe and beyond. The aim of this paper is to complement previous publications and provide

  7. An Official American Thoracic Society/European Society of Intensive Care Medicine/Society of Critical Care Medicine Clinical Practice Guideline: Mechanical Ventilation in Adult Patients with Acute Respiratory Distress Syndrome.

    PubMed

    Fan, Eddy; Del Sorbo, Lorenzo; Goligher, Ewan C; Hodgson, Carol L; Munshi, Laveena; Walkey, Allan J; Adhikari, Neill K J; Amato, Marcelo B P; Branson, Richard; Brower, Roy G; Ferguson, Niall D; Gajic, Ognjen; Gattinoni, Luciano; Hess, Dean; Mancebo, Jordi; Meade, Maureen O; McAuley, Daniel F; Pesenti, Antonio; Ranieri, V Marco; Rubenfeld, Gordon D; Rubin, Eileen; Seckel, Maureen; Slutsky, Arthur S; Talmor, Daniel; Thompson, B Taylor; Wunsch, Hannah; Uleryk, Elizabeth; Brozek, Jan; Brochard, Laurent J

    2017-05-01

    This document provides evidence-based clinical practice guidelines on the use of mechanical ventilation in adult patients with acute respiratory distress syndrome (ARDS). A multidisciplinary panel conducted systematic reviews and metaanalyses of the relevant research and applied Grading of Recommendations, Assessment, Development, and Evaluation methodology for clinical recommendations. For all patients with ARDS, the recommendation is strong for mechanical ventilation using lower tidal volumes (4-8 ml/kg predicted body weight) and lower inspiratory pressures (plateau pressure < 30 cm H2O) (moderate confidence in effect estimates). For patients with severe ARDS, the recommendation is strong for prone positioning for more than 12 h/d (moderate confidence in effect estimates). For patients with moderate or severe ARDS, the recommendation is strong against routine use of high-frequency oscillatory ventilation (high confidence in effect estimates) and conditional for higher positive end-expiratory pressure (moderate confidence in effect estimates) and recruitment maneuvers (low confidence in effect estimates). Additional evidence is necessary to make a definitive recommendation for or against the use of extracorporeal membrane oxygenation in patients with severe ARDS. The panel formulated and provided the rationale for recommendations on selected ventilatory interventions for adult patients with ARDS. Clinicians managing patients with ARDS should personalize decisions for their patients, particularly regarding the conditional recommendations in this guideline.

  8. [Evaluation of the status of patients with severe infection, criteria for intensive care unit admittance. Spanish Society for Infectious Diseases and Clinical Microbiology. Spanish Society of Intensive and Critical Medicine and Coronary Units].

    PubMed

    Olaechea, Pedro M; Alvarez-Lerma, Francisco; Sánchez, Miguel; Torres, Antonio; Palomar, Mercedes; Fernández, Pedro; Miró, José M; Cisneros, José Miguel; Torres, Manuel

    2009-06-01

    Recent studies have shown that early attention in patients with serious infections is associated with a better outcome. Assistance in intensive care units (ICU) can effectively provide this attention; hence patients should be admitted to the ICU as soon as possible, before clinical deterioration becomes irreversible. The objective of this article is to compile the recommendations for evaluating disease severity in patients with infections and describe the criteria for ICU admission, updating the criteria published 10 years ago. A literature review was carried out, compiling the opinions of experts from the Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (SEIMC, Spanish Society for Infectious Diseases and Clinical Microbiology) and the Sociedad Española de Medicina Intensiva, Crítica y Unidades Coronarias (SEMICYUC, Spanish Society for Intensive Medicine, Critical Care and Coronary Units) as well as the working groups for infections in critically ill patients (GEIPC-SEIMC and GTEI-SEMICYUC). We describe the specific recommendations for ICU admission related to the most common infections affecting patients, who will potentially benefit from critical care. Assessment of the severity of the patient's condition to enable early intensive care is stressed.

  9. American Society of Clinical Oncology Clinical Practice Guideline: Update on Adjuvant Endocrine Therapy for Women With Hormone Receptor–Positive Breast Cancer

    PubMed Central

    Burstein, Harold J.; Prestrud, Ann Alexis; Seidenfeld, Jerome; Anderson, Holly; Buchholz, Thomas A.; Davidson, Nancy E.; Gelmon, Karen E.; Giordano, Sharon H.; Hudis, Clifford A.; Malin, Jennifer; Mamounas, Eleftherios P.; Rowden, Diana; Solky, Alexander J.; Sowers, MaryFran R.; Stearns, Vered; Winer, Eric P.; Somerfield, Mark R.; Griggs, Jennifer J.

    2010-01-01

    Purpose To develop evidence-based guidelines, based on a systematic review, for endocrine therapy for postmenopausal women with hormone receptor–positive breast cancer. Methods A literature search identified relevant randomized trials. Databases searched included MEDLINE, PREMEDLINE, the Cochrane Collaboration Library, and those for the Annual Meetings of the American Society of Clinical Oncology (ASCO) and the San Antonio Breast Cancer Symposium (SABCS). The primary outcomes of interest were disease-free survival, overall survival, and time to contralateral breast cancer. Secondary outcomes included adverse events and quality of life. An expert panel reviewed the literature, especially 12 major trials, and developed updated recommendations. Results An adjuvant treatment strategy incorporating an aromatase inhibitor (AI) as primary (initial endocrine therapy), sequential (using both tamoxifen and an AI in either order), or extended (AI after 5 years of tamoxifen) therapy reduces the risk of breast cancer recurrence compared with 5 years of tamoxifen alone. Data suggest that including an AI as primary monotherapy or as sequential treatment after 2 to 3 years of tamoxifen yields similar outcomes. Tamoxifen and AIs differ in their adverse effect profiles, and these differences may inform treatment preferences. Conclusion The Update Committee recommends that postmenopausal women with hormone receptor–positive breast cancer consider incorporating AI therapy at some point during adjuvant treatment, either as up-front therapy or as sequential treatment after tamoxifen. The optimal timing and duration of endocrine treatment remain unresolved. The Update Committee supports careful consideration of adverse effect profiles and patient preferences in deciding whether and when to incorporate AI therapy. PMID:20625130

  10. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update.

    PubMed

    Wolff, Antonio C; Hammond, M Elizabeth H; Hicks, David G; Dowsett, Mitch; McShane, Lisa M; Allison, Kimberly H; Allred, Donald C; Bartlett, John M S; Bilous, Michael; Fitzgibbons, Patrick; Hanna, Wedad; Jenkins, Robert B; Mangu, Pamela B; Paik, Soonmyung; Perez, Edith A; Press, Michael F; Spears, Patricia A; Vance, Gail H; Viale, Giuseppe; Hayes, Daniel F

    2014-02-01

    To update the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for human epidermal growth factor receptor 2 (HER2) testing in breast cancer to improve the accuracy of HER2 testing and its utility as a predictive marker in invasive breast cancer. ASCO/CAP convened an Update Committee that included coauthors of the 2007 guideline to conduct a systematic literature review and update recommendations for optimal HER2 testing. The Update Committee identified criteria and areas requiring clarification to improve the accuracy of HER2 testing by immunohistochemistry (IHC) or in situ hybridization (ISH). The guideline was reviewed and approved by both organizations. The Update Committee recommends that HER2 status (HER2 negative or positive) be determined in all patients with invasive (early stage or recurrence) breast cancer on the basis of one or more HER2 test results (negative, equivocal, or positive). Testing criteria define HER2-positive status when (on observing within an area of tumor that amounts to >10% of contiguous and homogeneous tumor cells) there is evidence of protein overexpression (IHC) or gene amplification (HER2 copy number or HER2/CEP17 ratio by ISH based on counting at least 20 cells within the area). If results are equivocal (revised criteria), reflex testing should be performed using an alternative assay (IHC or ISH). Repeat testing should be considered if results seem discordant with other histopathologic findings. Laboratories should demonstrate high concordance with a validated HER2 test on a sufficiently large and representative set of specimens. Testing must be performed in a laboratory accredited by CAP or another accrediting entity. The Update Committee urges providers and health systems to cooperate to ensure the highest quality testing.

  11. Electronic nicotine delivery systems: a policy statement from the American Association for Cancer Research and the American Society of Clinical Oncology.

    PubMed

    Brandon, Thomas H; Goniewicz, Maciej L; Hanna, Nasser H; Hatsukami, Dorothy K; Herbst, Roy S; Hobin, Jennifer A; Ostroff, Jamie S; Shields, Peter G; Toll, Benjamin A; Tyne, Courtney A; Viswanath, Kasisomayajula; Warren, Graham W

    2015-03-10

    Combustible tobacco use remains the number-one preventable cause of disease, disability, and death in the United States. Electronic nicotine delivery systems (ENDS), which include electronic cigarettes, are devices capable of delivering nicotine in an aerosolized form. ENDS use by both adults and youth has increased rapidly, and some have advocated these products could serve as harm-reduction devices and smoking cessation aids. ENDS may be beneficial if they reduce smoking rates or prevent or reduce the known adverse health effects of smoking. However, ENDS may also be harmful, particularly to youth, if they increase the likelihood that nonsmokers or former smokers will use combustible tobacco products or if they discourage smokers from quitting. The American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO) recognize the potential ENDS have to alter patterns of tobacco use and affect the health of the public; however, definitive data are lacking. The AACR and ASCO recommend additional research on these devices, including assessing the health impacts of ENDS, understanding patterns of ENDS use, and determining what role ENDS have in cessation. Key policy recommendations include supporting federal, state, and local regulation of ENDS; requiring manufacturers to register with the US Food and Drug Administration and report all product ingredients, requiring childproof caps on ENDS liquids, and including warning labels on products and their advertisements; prohibiting youth-oriented marketing and sales; prohibiting child-friendly ENDS flavors; and prohibiting ENDS use in places where cigarette smoking is prohibited. This policy statement was developed by a joint writing group composed of members from the Tobacco and Cancer Subcommittee of the American Association for Cancer Research (AACR) Science Policy and Government Affairs (SPGA) Committee and American Society of Clinical Oncology (ASCO) Tobacco Cessation and Control

  12. Society of Surgical Oncology-American Society for Radiation Oncology-American Society of Clinical Oncology Consensus Guideline on Margins for Breast-Conserving Surgery With Whole-Breast Irradiation in Ductal Carcinoma In Situ.

    PubMed

    Morrow, Monica; Van Zee, Kimberly J; Solin, Lawrence J; Houssami, Nehmat; Chavez-MacGregor, Mariana; Harris, Jay R; Horton, Janet; Hwang, Shelley; Johnson, Peggy L; Marinovich, M Luke; Schnitt, Stuart J; Wapnir, Irene; Moran, Meena S

    2016-11-20

    Background Controversy exists regarding the optimal negative margin width for ductal carcinoma in situ (DCIS) treated with breast-conserving surgery and whole-breast irradiation (WBRT). Methods A multidisciplinary consensus panel used a meta-analysis of margin width and ipsilateral breast tumor recurrence (IBTR) from a systematic review of 20 studies including 7883 patients and other published literature as the evidence base for consensus. Results Negative margins halve the risk of IBTR compared with positive margins defined as ink on DCIS. A 2 mm margin minimizes the risk of IBTR compared with smaller negative margins. More widely clear margins do not significantly decrease IBTR compared with 2 mm margins. Negative margins less than 2 mm alone are not an indication for mastectomy, and factors known to impact rates of IBTR should be considered in determining the need for re-excision. Conclusion The use of a 2 mm margin as the standard for an adequate margin in DCIS treated with WBRT is associated with low rates of IBTR and has the potential to decrease re-excision rates, improve cosmetic outcome, and decrease health care costs. Clinical judgment should be used in determining the need for further surgery in patients with negative margins < 2 mm.

  13. National MPS Society (Mucopolysaccharidoses)

    MedlinePlus

    ... realistic expectations for therapies, hear about clinical trial design and recruitment effort and reiterate the importance of ... Copyright © National MPS Society. All Rights Reserved. Web Design & Development by TheeDesign

  14. Removal of foreign bodies in the upper gastrointestinal tract in adults: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline.

    PubMed

    Birk, Michael; Bauerfeind, Peter; Deprez, Pierre H; Häfner, Michael; Hartmann, Dirk; Hassan, Cesare; Hucl, Tomas; Lesur, Gilles; Aabakken, Lars; Meining, Alexander

    2016-05-01

    This Guideline is an official statement of the European Society of Gastrointestinal Endoscopy (ESGE). It addresses the removal of foreign bodies in the upper gastrointestinal tract in adults. Recommendations Nonendoscopic measures 1 ESGE recommends diagnostic evaluation based on the patient's history and symptoms. ESGE recommends a physical examination focused on the patient's general condition and to assess signs of any complications (strong recommendation, low quality evidence). 2 ESGE does not recommend radiological evaluation for patients with nonbony food bolus impaction without complications. We recommend plain radiography to assess the presence, location, size, configuration, and number of ingested foreign bodies if ingestion of radiopaque objects is suspected or type of object is unknown (strong recommendation, low quality evidence). 3 ESGE recommends computed tomography (CT) scan in all patients with suspected perforation or other complication that may require surgery (strong recommendation, low quality evidence). 4 ESGE does not recommend barium swallow, because of the risk of aspiration and worsening of the endoscopic visualization (strong recommendation, low quality evidence). 5 ESGE recommends clinical observation without the need for endoscopic removal for management of asymptomatic patients with ingestion of blunt and small objects (except batteries and magnets). If feasible, outpatient management is appropriate (strong recommendation, low quality evidence). 6 ESGE recommends close observation in asymptomatic individuals who have concealed packets of drugs by swallowing ("body packing"). We recommend against endoscopic retrieval. We recommend surgical referral in cases of suspected packet rupture, failure of packets to progress, or intestinal obstruction (strong recommendation, low quality evidence). Endoscopic measures 7 ESGE recommends emergent (preferably within 2 hours, but at the latest within 6 hours) therapeutic esophagogastroduodenoscopy for

  15. Recruiting egg donors online: an analysis of in vitro fertilization clinic and agency websites' adherence to American Society for Reproductive Medicine guidelines.

    PubMed

    Keehn, Jason; Holwell, Eve; Abdul-Karim, Ruqayyah; Chin, Lisa Judy; Leu, Cheng-Shiun; Sauer, Mark V; Klitzman, Robert

    2012-10-01

    To examine compliance with ethical guidelines of the American Society for Reproductive Medicine (ASRM) regarding trait-based payment variation, presentation of risks, and minimum recruitment age. In June 2010, we systematically examined 207 websites, of which 102 were egg donor agency or IVF clinic websites that both recruited online and displayed compensation amounts. The Internet. None. Not applicable. Mention of increased payment for particular donor traits, recruitment age less than 21 years, noting risks to donors. Of the 102 sites, considerable numbers were noncompliant with ASRM's guidelines that prohibit varying compensation based on a donor's traits (34%), and recommend an age of 21 years or older (41%), and presentation of risks alongside compensation (56%). Trait-based payment variation was associated with being an agency rather than a clinic, location in the West, not being endorsed by ASRM or Society of Assisted Reproductive Technology (SART), and referring to ASRM's guidelines about compensation. Of sites mentioning traits, prior donation success was the most commonly paid for trait (64%). Our data, the first to systematically analyze agency and clinic websites reveal that many do not follow ASRM's guidelines. These data have critical implications for policy, practice, and research, suggesting needs for consideration of possible changes in guidelines, and/or improvements in compliance and monitoring by ASRM or others. Copyright © 2012 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  16. [Analysis of the results of the 2010 External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology].

    PubMed

    Ruiz de Gopegui Bordes, Enrique; Serrano, M del Remedio Guna; Orta Mira, Nieves; Ovies, María Rosario; Poveda, Marta; Cardona, Concepción Gimeno

    2011-12-01

    The External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology includes controls for bacteriology, serology, mycology, parasitology, mycobacteria, virology and molecular microbiology. This article presents the most important conclusions and lessons of the 2010 controls. As a whole, the results obtained in 2010 confirm the excellent skill and good technical standards found in previous years. However, erroneous results can be obtained in any laboratory and in clinically relevant determinations. The results of this program highlight the need to implement both internal and external controls to ensure maximal quality of microbiological tests(1).

  17. Highlights from the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) (June 3-7, 2016 - Chicago, Illinois, USA).

    PubMed

    Kibble, A; Al-Shamahi, A; Kuennemann, K; Marqués, F; Tremosa, L; Cole, P

    2016-07-01

    The theme of the 52nd Annual American Society of Clinical Oncology (ASCO) meeting, 'Collective Wisdom', was intended to represent the importance of consolidating clinical advances with expertise in areas such as health informatics, pathology and economics in order to improve the role of practice providers in delivering cancer patients every component of quality care. As expected, immunotherapy and precision medicine featured heavily in the 2016 program. Gathering 30,000 oncology professionals in Chicago, educational and science sessions gave the attendees the opportunity to discuss and view ground-breaking research. Copyright 2016 Prous Science, S.A.U. or its licensors. All rights reserved.

  18. Planetary Society

    NASA Astrophysics Data System (ADS)

    Murdin, P.

    2000-11-01

    Carl Sagan, Bruce Murray and Louis Friedman founded the non-profit Planetary Society in 1979 to advance the exploration of the solar system and to continue the search for extraterrestrial life. The Society has its headquarters in Pasadena, California, but is international in scope, with 100 000 members worldwide, making it the largest space interest group in the world. The Society funds a var...

  19. [Consensus statement of the National AIDS Plan Secretariat, Spanish Society of Emergency Medicine and AIDS Study Group of the Spanish Society of Infectious Diseases and Clinical Microbiology on Emergency and Human Immunodeficiency Virus Infection].

    PubMed

    2013-01-01

    Supporting non-HIV specialist professionals in the treatment of patients with urgent diseases resulting from HIV infection. These recommendations have been agreed by an expert panel from the National AIDS Plan Secretariat, the Spanish Society of Emergency Medicine, and the AIDS Study Group. A review has been made of the safety and efficacy results of clinical trials and cohort studies published in biomedical journals (PubMed and Embase) or presented at conferences. The strength of each recommendation (A, B, C) and the level of supporting evidence (I, II, III) are based on a modification of the criteria of the Infectious Diseases Society of America. The data to be collected from the emergency medical history in order to recognize the patient at risk of HIV infection were specified. It stressed the basic knowledge of ART principles and its importance in terms of decline in morbidity and mortality of HIV+ patients and referring to the HIV specialist for follow-up, where appropriate, including drug interactions. Management of different emergency situations that may occur in patients with HIV infection is also mentioned. The non-HIV specialist professional, will find the necessary tools to approach HIV patients with an emergency disease. Copyright © 2012 Elsevier España, S.L. All rights reserved.

  20. International Association for the Study of Lung Cancer/American Thoracic Society/European Respiratory Society classification predicts occult lymph node metastasis in clinically mediastinal node-negative lung adenocarcinoma

    PubMed Central

    Yeh, Yi-Chen; Kadota, Kyuichi; Nitadori, Jun-ichi; Sima, Camelia S.; Rizk, Nabil P.; Jones, David R.; Travis, William D.; Adusumilli, Prasad S.

    2016-01-01

    OBJECTIVES We investigated the role of the 2011 International Association for the Study of Lung Cancer, American Thoracic Society, and European Respiratory Society (IASLC/ATS/ERS) classification in predicting occult lymph node metastasis in clinically mediastinal node-negative lung adenocarcinoma. METHODS We reviewed lung adenocarcinoma patients who had clinically N2-negative status, were evaluated by preoperative positron emission tomography combined with computed tomography (PET/CT) and had undergone lobectomy or pneumonectomy at Memorial Sloan Kettering Cancer Center (n = 297). Tumours were classified according to the 2011 IASLC/ATS/ERS classification. The associations between occult lymph node metastasis and clinicopathological variables were analysed using Fisher's exact test and logistic regression analysis. RESULTS Thirty-two (11%) cN0-1 patients had occult mediastinal lymph node metastasis (pN2) whereas 25% of cN1 patients had pN2 disease. Increased micropapillary pattern was associated with increased risk of pN2 disease (P = 0.001). On univariate analysis, high maximum standard uptake value of the primary tumour on PET/CT (P = 0.019) and the presence of micropapillary (P = 0.014) and solid pattern (P = 0.014) were associated with occult pN2 disease. On multivariable analysis, micropapillary pattern was positively associated with risk of pN2 disease (odds ratio = 3.41; 95% confidence intervals = 1.42–8.19; P = 0.006). CONCLUSIONS The presence of micropapillary pattern is an independent predictor of occult mediastinal lymph node metastasis. Our observations have potential therapeutic implications for management of early-stage lung adenocarcinoma. PMID:26377636

  1. Multivariate analysis of factors affecting probability of pregnancy and live birth with in vitro fertilization: an analysis of the Society for Assisted Reproductive Technology Clinic Outcomes Reporting System.

    PubMed

    Baker, Valerie L; Luke, Barbara; Brown, Morton B; Alvero, Ruben; Frattarelli, John L; Usadi, Rebecca; Grainger, David A; Armstrong, Alicia Y

    2010-09-01

    To evaluate factors predictive of clinical pregnancy and of pregnancy loss from assisted reproductive technology (ART) using data from the Society for Assisted Reproductive Technology database for 2004-2006. Retrospective cohort. Clinic-based data. The study population included 225,889 fresh embryo transfer cycles using autologous oocytes and partner semen. None. Clinical intrauterine gestation (presence of gestational sac) and live birth (>or=22 weeks gestation and >or=300 g birth weight). Increasing maternal age was significantly associated with a reduced odds of conception and increased fetal loss until 19 weeks gestation, but not with later pregnancy loss. Intracytoplasmic sperm injection (ICSI), assisted hatching, and increasing number of embryos transferred had significant positive effects on the odds of conception and pregnancy continuation through the first trimester, but did not affect the risk of later loss. Blacks, Asians, and Hispanics had significantly lower odds of clinical pregnancy compared with whites. Also compared with whites, Hispanics and Asians had a significantly greater risk of pregnancy loss in the second and third trimesters, and blacks had a significantly greater risk of pregnancy loss in all trimesters. Certain demographic and ART treatment parameters influenced chance of conception and early pregnancy loss, whereas black race and Hispanic ethnicity were also significantly associated with late pregnancy loss in ART-conceived pregnancies. Copyright (c) 2010 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  2. [Guidelines for the treatment of invasive fungal disease by Aspergillus spp. and other fungi issued by the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC). 2011 Update].

    PubMed

    Fortún, Jesús; Carratalá, Jordi; Gavaldá, Joan; Lizasoain, Manuel; Salavert, Miguel; de la Cámara, Rafael; Borges, Marcio; Cervera, Carlos; Garnacho, José; Lassaleta, Álvaro; Lumbreras, Carlos; Sanz, Miguel Ángel; Ramos, José T; Torre-Cisneros, Julián; Aguado, José M; Cuenca-Estrella, Manuel

    2011-01-01

    The guidelines on the treatment of invasive fungal disease by Aspergillus spp. and other fungi issued by the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) are presented. These recommendations are focused on four clinical categories: oncology-haematology patients, solid organ transplant recipients, patients admitted to intensive care units, and children. An extensive review is made of therapeutical advances and scientific evidence in these settings. These guidelines have been prepared according the SEIMC consensus rules by a working group composed of specialists in infectious diseases, clinical microbiology, critical care medicine, paediatrics and oncology-haematology. Specific recommendations on the prevention of fungal infections in these patients are included. Copyright © 2011 Elsevier España, S.L. All rights reserved.

  3. An Official American Thoracic Society Workshop Report. A Framework for Addressing Multimorbidity in Clinical Practice Guidelines for Pulmonary Disease, Critical Illness, and Sleep Disorders.

    PubMed

    Wilson, Kevin C; Gould, Michael K; Krishnan, Jerry A; Boyd, Cynthia M; Brozek, Jan L; Cooke, Colin R; Douglas, Ivor S; Goodman, Richard A; Joo, Min J; Lareau, Suzanne; Mularski, Richard A; Patel, Minal R; Rosenfeld, Richard M; Shanawani, Hasan; Slatore, Christopher; Sockrider, Marianna; Sufian, Beth; Thomson, Carey C; Wiener, Renda Soylemez

    2016-03-01

    Coexistence of multiple chronic conditions (i.e., multimorbidity) is the most common chronic health problem in adults. However, clinical practice guidelines have primarily focused on patients with a single disease, resulting in uncertainty about the care of patients with multimorbidity. The American Thoracic Society convened a workshop with the goal of establishing a strategy to address multimorbidity within clinical practice guidelines. In this Workshop Report, we describe a framework that addresses multimorbidity in each of the key steps of guideline development: topic selection, panel composition, identifying clinical questions, searching for and synthesizing evidence, rating the quality of that evidence, summarizing benefits and harms, formulating recommendations, and rating the strength of the recommendations. For the consideration of multimorbidity in guidelines to be successful and sustainable, the process must be both feasible and pragmatic. It is likely that this will be achieved best by the step-wise addition and refinement of the various components of the framework.

  4. Validation of the Tensoval Duo Control II blood pressure monitor for clinic use and self-measurement according to the British Hypertension Society protocol and the European Society of Hypertension International Protocol Revision 2010.

    PubMed

    de Greeff, Annemarie; Shennan, Andrew H

    2013-06-01

    The Tensoval Duo Control II is an automated upper arm device that uses a combination of oscillometric and auscultatory technology to determine blood pressure noninvasively. The accuracy of this device was assessed according to the British Hypertension Society (BHS) protocol and the European Society of Hypertension International Protocol revision 2010 (ESH-IP2) in an adult population. Ethical approval was obtained. Eighty-five and 33 adult individuals, respectively, were recruited to fulfil the requirements of each protocol. Trained observers took nine sequential same-arm measurements alternating between a mercury sphygmomanometer and the device. The device had to achieve at least a B grade for both systolic and diastolic pressures to pass the BHS protocol and had to fulfil the criteria of all three phases of the ESH-IP2 protocol to receive recommendation. The device achieved an A/A grading for the BHS protocol and passed all three phases of the ESH-IP2 protocol. The mean difference±SD for the BHS/ESH protocols, respectively, was -1.8±6.5/-0.7±5.7 mmHg for systolic pressure and 1.9±5.1/2.4±4.5 mmHg for diastolic pressure. The device maintained its A/A grading throughout the low-pressure, medium-pressure and high-pressure ranges. The Tensoval Duo Control II device is recommended for clinical and home use according to both the BHS and the ESH-IP2 standard.

  5. Clinical management of primary non-acute promyelocytic leukemia acute myeloid leukemia: Practice Guidelines by the Italian Society of Hematology, the Italian Society of Experimental Hematology, and the Italian Group for Bone Marrow Transplantation.

    PubMed

    Morra, Enrica; Barosi, Giovanni; Bosi, Alberto; Ferrara, Felicetto; Locatelli, Franco; Marchetti, Monia; Martinelli, Giovanni; Mecucci, Cristina; Vignetti, Marco; Tura, Sante

    2009-01-01

    As many options are now available to treat patients with de novo acute myeloid leukemia, the Italian Society of Hematology and two affiliated societies (SIES and GITMO) commissioned project to an Expert Panel aimed at developing clinical practice guidelines for acute myeloid leukemia treatment. After systematic comprehensive literature review, the Expert Panel formulated recommendations for the management of primary acute myeloid leukemia (with the exception of acute promyelocytic leukemia) and graded them according to the supporting evidence. When evidence was lacking, consensus-based statements have been added. First-line therapy for all newly diagnosed patients eligible for intensive treatment should include one cycle of induction with standard dose cytarabine and an anthracycline. After achieving complete remission, patients aged less than 60 years should receive consolidation therapy including high-dose cytarabine. Myeloablative allogeneic stem cell transplantation from an HLA-compatible sibling should be performed in first complete remission: 1) in children with intermediate-high risk cytogenetics or who achieved first complete remission after the second course of therapy; 2) in adults less than 40 years with an intermediate-risk; in those aged less than 55 years with either high-risk cytogenetics or who achieved first complete remission after the second course of therapy. Stem cell transplantation from an unrelated donor is recommended to be performed in first complete remission in adults 30 years old or younger, and in children with very high-risk disease lacking a sibling donor. Alternative donor stem cell transplantation is an option in high-risk patients without a matched donor who urgently need transplantation. Patients aged less than 60 years, who either are not candidate for allogeneic stem cell transplantation or lack a donor, are candidates for autologous stem cell transplantation. We describe the results of a systematic literature review and an

  6. Guidelines of the Infectious Diseases Society of America for the Treatment of Methicillin-Resistant Staphylococcus aureus Infections: As Applied to Oral and Maxillofacial Clinical Practice.

    PubMed

    Bhargava, Darpan; Deshpande, Ashwini; Sreekumar, K; Koneru, Ganesh; Rastogi, Shobhit

    2013-09-01

    The purpose of this paper was to undertake a systematic review of literature on methicillin-resistant Staphylococcus aureus infections in oral and maxillofacial online data-bases and discuss the Infectious Diseases Society of America (IDSA) guidelines and its applications in maxillofacial clinical practice. The available literature in oral and maxillofacial online databases was searched. The only inclusion criterion was to review published reports, abstracts and retrospective studies with emphasis on the treatment of clinical cases with methicillin-resistant S. aureus infections. Clinical Practice Guidelines by the Infectious Diseases Society of America for the treatment of methicillin-resistant S. aureus infections in adults and children was reviewed and included in the study. Out of 18 articles found with the search terms "Methicillin-resistant S. aureus" and "MRSA" in the online databases 12 articles met the inclusion criteria for this study. The relevant data was extracted and tabulated. Conclusions were drawn and discussed based on the reviewed maxillofacial literature and the Guidelines by the IDSA.

  7. Diabetes and cardiovascular disease: from evidence to clinical practice – position statement 2014 of Brazilian Diabetes Society

    PubMed Central

    2014-01-01

    There is a very well known correlation between diabetes and cardiovascular disease but many health care professionals are just concerned with glycemic control, ignoring the paramount importance of controlling other risk factors involved in the pathogenesis of serious cardiovascular diseases. This Position Statement from the Brazilian Diabetes Society was developed to promote increased awareness in relation to six crucial topics dealing with diabetes and cardiovascular disease: Glicemic Control, Cardiovascular Risk Stratification and Screening Coronary Artery Disease, Treatment of Dyslipidemia, Hypertension, Antiplatelet Therapy and Myocardial Revascularization. The issue of what would be the best algorithm for the use of statins in diabetic patients received a special attention and a new Brazilian algorithm was developed by our editorial committee. This document contains 38 recommendations which were classified by their levels of evidence (A, B, C and D). The Editorial Committee included 22 specialists with recognized expertise in diabetes and cardiology. PMID:24855495

  8. A report from the 47th Annual Meeting of the American Society of Clinical Oncology (June 3-7, 2011 - Chicago, Illinois, USA).

    PubMed

    Rabasseda, X; Gómez-Zaera, M

    2011-09-01

    Improving survival, as well as the quality of life and functioning of survivors, is the main objective of cancer therapy, for which a very large number of drugs are currently available or under development as therapeutic candidates. Information on many of these compounds was discussed during the 2011 American Society of Clinical Oncology (ASCO) meeting in Chicago. The number of news presentations discussed during the meeting was incredibly high, with plenary, oral abstract, poster discussion and general poster sessions filling room upon room. The following report provides a quick review of major new research into drug and support therapies for cancer as presented at the meeting.

  9. American Society of Nuclear Cardiology

    MedlinePlus

    ... much more! class="box-li"> Journal of Nuclear Cardiology Official publication of the American Society of Nuclear Cardiology Clinical Guidelines Procedures, Appropriate Use Criteria, Information Statements ...

  10. Brigham and Women's Hospital three-time winner of the American Pain Society Clinical Centers of Excellence Award.

    PubMed

    Ross, Edgar

    2017-01-01

    Edgar Ross speaks to Jade Parker, Commissioning Editor: Dr Edgar Ross is a member of the Anesthesia Department at Brigham and Women's Hospital. His main office is in Chesnut Hill, an ambulatory care center for Brigham and Women's hospital. He received his medical degree from Wayne State University School of Medicine and has been in practice for more than 30 years, 20 years in his current position at Brigham and Women's Hospital. His two main clinical interests are; the phone app which is designed to become the main clinical tool for patients and second, the relationship between opioids and angiogenesis.

  11. Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America

    PubMed Central

    Pappas, Peter G.; Kauffman, Carol A.; Andes, David R.; Clancy, Cornelius J.; Marr, Kieren A.; Ostrosky-Zeichner, Luis; Reboli, Annette C.; Schuster, Mindy G.; Vazquez, Jose A.; Walsh, Thomas J.; Zaoutis, Theoklis E.; Sobel, Jack D.

    2016-01-01

    It is important to realize that guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations. IDSA considers adherence to these guidelines to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient's individual circumstances. PMID:26679628

  12. An official American Thoracic Society clinical practice guideline: classification, evaluation, and management of childhood interstitial lung disease in infancy.

    PubMed

    Kurland, Geoffrey; Deterding, Robin R; Hagood, James S; Young, Lisa R; Brody, Alan S; Castile, Robert G; Dell, Sharon; Fan, Leland L; Hamvas, Aaron; Hilman, Bettina C; Langston, Claire; Nogee, Lawrence M; Redding, Gregory J

    2013-08-01

    There is growing recognition and understanding of the entities that cause interstitial lung disease (ILD) in infants. These entities are distinct from those that cause ILD in older children and adults. A multidisciplinary panel was convened to develop evidence-based guidelines on the classification, diagnosis, and management of ILD in children, focusing on neonates and infants under 2 years of age. Recommendations were formulated using a systematic approach. Outcomes considered important included the accuracy of the diagnostic evaluation, complications of delayed or incorrect diagnosis, psychosocial complications affecting the patient's or family's quality of life, and death. No controlled clinical trials were identified. Therefore, observational evidence and clinical experience informed judgments. These guidelines: (1) describe the clinical characteristics of neonates and infants (<2 yr of age) with diffuse lung disease (DLD); (2) list the common causes of DLD that should be eliminated during the evaluation of neonates and infants with DLD; (3) recommend methods for further clinical investigation of the remaining infants, who are regarded as having "childhood ILD syndrome"; (4) describe a new pathologic classification scheme of DLD in infants; (5) outline supportive and continuing care; and (6) suggest areas for future research. After common causes of DLD are excluded, neonates and infants with childhood ILD syndrome should be evaluated by a knowledgeable subspecialist. The evaluation may include echocardiography, controlled ventilation high-resolution computed tomography, infant pulmonary function testing, bronchoscopy with bronchoalveolar lavage, genetic testing, and/or lung biopsy. Preventive care, family education, and support are essential.

  13. Executive Summary: Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America.

    PubMed

    Pappas, Peter G; Kauffman, Carol A; Andes, David R; Clancy, Cornelius J; Marr, Kieren A; Ostrosky-Zeichner, Luis; Reboli, Annette C; Schuster, Mindy G; Vazquez, Jose A; Walsh, Thomas J; Zaoutis, Theoklis E; Sobel, Jack D

    2016-02-15

    It is important to realize that guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations. IDSA considers adherence to these guidelines to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient's individual circumstances.

  14. Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America.

    PubMed

    Pappas, Peter G; Kauffman, Carol A; Andes, David R; Clancy, Cornelius J; Marr, Kieren A; Ostrosky-Zeichner, Luis; Reboli, Annette C; Schuster, Mindy G; Vazquez, Jose A; Walsh, Thomas J; Zaoutis, Theoklis E; Sobel, Jack D

    2016-02-15

    It is important to realize that guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations. IDSA considers adherence to these guidelines to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient's individual circumstances.

  15. How to manage recurrent falls in clinical practice: guidelines of the French Society of Geriatrics and Gerontology.

    PubMed

    Beauchet, Olivier; Dubost, V; Revel Delhom, C; Berrut, G; Belmin, J

    2011-01-01

    Health care professionals need a simple and pragmatic clinical approach for the management of recurrent fallers in clinical routine. To develop clinical practice recommendations with the aim to assist health care professionals, especially in primary care in the management of recurrent falls. A systematic English and French review was conducted using Medline, Embase, Pascal and Cochrane literature. Search included systematic reviews, meta-analyses, controlled trials, cohort studies, case-control studies and transversal studies published until July 31, 2008. The following Medical Subject Heading (MeSH) terms were used: "aged OR aged, 80 and over", "frail elderly", "Accidental Fall", "Mental Recall", and "Recurrent falls". The guidelines were elaborated according the Haute Autorite de Sante methods by a multidisciplinary working group comprising experts and practitioners. A fall is an event that results in a person coming to rest inadvertently on the ground or floor or other lower level and should be considered as a recurrent event as soon as a subject reported at least two falls in a 12-month period. Recurrent falls impose a prompt and appropriate management with the first aim to systematically evaluate the severity of falls. The evaluation of fall severity should be based on a standardized questionnaire and physical examination. It is recommended not to perform cerebral imaging in the absence of specific indication based on the clinical examination and to reevaluate the subject within a week after the fall. Prior to any intervention and after an evaluation of signs of severity, it is recommended to systematically assess the risk factors for falls. This evaluation should be based on the use of validated and standardized tests. The education of recurrent fallers and their care givers is required in order to implement appropriate intervention. In the event of a gait and/or balance disorders, it is recommended to prescribe physiotherapy. A regular physical activity

  16. Clinical evaluation of quality of life: a survey among members of European Society of Thoracic Surgeons (ESTS).

    PubMed

    Pompili, Cecila; Novoa, Nuria; Balduyck, Bram

    2015-10-01

    Quality of life (QoL) has been recognized as an important postoperative outcome. Despite the growing interest in this topic, there is almost no information about the daily use of QoL questionnaires within European Society of Thoracic Surgery (ESTS). The aim of this paper is to present the results of a survey launched to know the current practice of collecting and using QoL data within the Society. The survey was designed by the members of the QoL and Patient Safety ESTS committee and included 13 questions about different aspects of QoL assessment: time points of data collection, type and method of administration of questionnaires, dropouts, surgical-related symptoms and definition of the target population. An electronic link was sent to invite 1250 ESTS members to complete the survey by e-mail. One hundred and fifty surgeons worldwide completed the survey. Of the total, 54.4% of the surgeons indicated that they never collect QoL data in their daily practice. Both SF-36 and EORTC C30 were the most commonly used questionnaires. They are considered as the most appropriate for thoracic surgery patients. Only 20% of the surgeons used the LC-13 module in addition. Most of the time (45.5%), questionnaires are completed through a face-to-face interview led by a physician. Only 21.2% of the responders collected data prior to surgery; 39.3% of the responders collect QoL data only from lung cancer patients and 16% add patients with oesophageal diseases. Postoperative complications, comorbidities, surgical and oncological baseline data and wound pain, healing disorders, arm mobility, oxygen dependency, return to work and postoperative medication were important items that responders suggested to include in future questionnaires. The obtained data showed a broad area for improvement in QoL. The ESTS has to lead this effort collaborating to standardize the research in this field, endorsing specific questionnaires, incorporating patient-reported outcomes more and more into

  17. The European Society for Medical Oncology Magnitude of Clinical Benefit Scale in daily practice: a single institution, real-life experience at the Medical University of Vienna

    PubMed Central

    Kiesewetter, Barbara; Raderer, Markus; Steger, Günther G; Bartsch, Rupert; Pirker, Robert; Zöchbauer-Müller, Sabine; Prager, Gerald; Krainer, Michael; Preusser, Matthias; Schmidinger, Manuela; Zielinski, Christoph C

    2016-01-01

    Background The European Society for Medical Oncology (ESMO) Magnitude of Clinical Benefit Scale (MCBS) has been designed to stratify the therapeutic benefit of a certain drug registered for the treatment of cancer. However, though internally validated, this tool has not yet been evaluated for its feasibility in the daily practice of a major center of medical oncology. Methods The practicability of the MCBS for advanced oncological diseases at the Clinical Division of Oncology, Medical University of Vienna, which constitutes one of the largest oncological centres in Europe, was analysed in a three-step approach. First, retrospectively collected data were analysed to gain an overview of treatments in regular use. Second, data were scored by using the MCBS. Third, the ensuing results were evaluated within corresponding programme directorships to assess feasibility in a real-life clinical context. Results In the majority of tumour entities, the MCBS results reported earlier are consistent with daily clinical practice. Thus, in metastatic breast cancer or advanced lung cancer, there was a high level of clinical benefit for first-line treatment standards, and these results reflected well real-life experience. However, analyses based on the first version of the MCBS are limited if it comes to salvage treatment in tumour entities in which optimal sequencing of potential treatment options is of major importance, as in metastatic colorectal or renal cell cancer. In contrast to this, it is remarkable that certain novel therapies such as nivolumab assessed for heavily pretreated advanced renal cancer reached the highest level of clinical benefit due to prolongation in survival and a favourable toxicity profile. The MCBS clearly underlines the potential benefit of these compounds. Conclusions The MCBS is an excellent tool for daily clinical practice of a tertiary referral centre. It supports treatment decisions based on the clinical benefit to be expected from a novel approach

  18. [Clinical practice guidelines of the Andalusian Epilepsy Society on prophylaxis and treatment of acute symptomatic epileptic seizures].

    PubMed

    Mercadé-Cerdá, J M; Gascón-Jiménez, F J; Ramos-Lizana, J; Sánchez-Alvarez, J C; Serrano-Castro, P J

    Antiepileptic drugs (AED) have traditionally been used empirically to prevent the presentation of epileptic seizures in patients with acute brain disorders during the early or late phase. However, AED are not free of serious drawbacks, which means that their use should be based on solid scientific foundations. Our aim is to produce a set of practice guidelines based on explicit evidence about when prophylactic treatment with AED is indicated and the length of time it should be continued in acute symptomatic seizures (ASS). A selective search for quality scientific information on the subject was conducted on PubMed-Medline, Tripdatabase and the Biblioteca Cochrane Plus. The authors discussed and analysed the references that were selected and any recommendations that could be drawn from them were collected. A total of 14 primary documents and eight practice guidelines, protocols or experts' recommendations were identified. Our recommendations were explicitly included at the end of the document. The Andalusian Epilepsy Society makes the following recommendations: a) AED must only be used for the primary prevention of ASS in severe traumatic brain injury and as secondary prevention of new ASS due to other causes of acute brain damage; b) duration of treatment of ASS must not exceed the time needed to resolve the cause that gave rise to them; and c) benzodiazepines are the preferred drugs for use in the treatment of ASS due to alcohol withdrawal and magnesium sulphate for the ASS of eclampsia.

  19. [Guidelines for the treatment of Invasive Candidiasis and other yeasts. Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC). 2010 Update].

    PubMed

    Aguado, José María; Ruiz-Camps, Isabel; Muñoz, Patricia; Mensa, José; Almirante, Benito; Vázquez, Lourdes; Rovira, Montserrat; Martín-Dávila, Pilar; Moreno, Asunción; Alvarez-Lerma, Francisco; León, Cristóbal; Madero, Luis; Ruiz-Contreras, Jesús; Fortún, Jesús; Cuenca-Estrella, Manuel

    2011-05-01

    These guidelines are an update of the recommendations of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) that were issued in 2004 (Enferm Infecc Microbiol Clin. 2004, 22:32-9) on the treatment of Invasive Candidiasis and infections produced by other yeasts. This 2010 update includes a comprehensive review of the new drugs that have appeared in recent years, as well as the levels of evidence for recommending them. These guidelines have been developed following the rules of the SEIMC by a working group composed of specialists in infectious diseases, clinical microbiology, critical care medicine, paediatrics and oncology-haematology. It provides a series of general recommendations regarding the management of invasive candidiasis and other yeast infections, as well as specific guidelines for prophylaxis and treatment, which have been divided into four sections: oncology-haematology, solid organ transplantation recipients, critical patients, and paediatric patients.

  20. Updates in non-small cell lung cancer - insights from the 2009 45th annual meeting of the American Society of Clinical Oncology

    PubMed Central

    2010-01-01

    We have reviewed the pivotal presentations in non-small cell lung cancer (NSCLC) from the 2009 annual meeting of the American Society of Clinical Oncology. We have discussed the scientific data, the impact on standards of care, and ongoing clinical trials. In patients with early-stage NSCLC, there is still no data to support the superiority of either neoadjuvant or adjuvant chemotherapy. However, adjuvant cisplatin-based chemotherapy has sustained the survival benefits after median follow-up of more than 9 years. The first-line treatment with inhibitors of epidermal growth factor receptor (EGFR) could be considered for the treatment of EGFR mutated patients with metastatic disease. Several maintenance studies with cytotoxic or biological agents have also demonstrated promising outcomes. Finally, novel targeted agents such as inhibitors of histone deacetylase and multi-targeted tyrosine kinase inhibitor have shown promising activity in NSCLC treatment. PMID:20433767

  1. Guidelines for the prevention of invasive mould diseases caused by filamentous fungi by the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC).

    PubMed

    Ruiz-Camps, I; Aguado, J M; Almirante, B; Bouza, E; Ferrer-Barbera, C F; Len, O; Lopez-Cerero, L; Rodríguez-Tudela, J L; Ruiz, M; Solé, A; Vallejo, C; Vazquez, L; Zaragoza, R; Cuenca-Estrella, M

    2011-04-01

    Invasive fungal infections (IFIs) caused by filamentous fungi still have high rates of mortality, associated with difficulties in early detection of the infection and therapeutic limitations. Consequently, a useful approach is to prevent patients at risk of fungal infection from coming into contact with conidia of Aspergillus and other mould species. This document describes the recommendations for preventing IFI caused by filamentous fungi worked out by Spanish experts from different medical and professional fields. The article reviews the incidence of IFI in different risk populations, and questions related to environmental measures for prevention, control of hospital infections, additional procedures for prevention, prevention of IFI outside of hospital facilities and antifungal prophylaxis are also analysed. © 2011 The Authors. Clinical Microbiology and Infection © 2011 European Society of Clinical Microbiology and Infectious Diseases.

  2. Chronic kidney disease certification process manual by the Italian Society of Nephrology (SIN): Part I: clinical care delivery and performance measurements and improvement.

    PubMed

    Quintaliani, Giuseppe; Cappelli, Gianni; Lodetti, Laura; Manno, Corrado; Petrucci, Virgilio; Spinelli, Cosimo; Tarchini, Renzo; Virgilio, Michele; Faini, Mario; Alloatti, Sandro; Cancarini, Giovanni; Zoccali, Carmine

    2009-01-01

    Chronic kidney diseases (CKD) has now emerged as a public health priority, and there is an increasing demand by patients and health care organisations that the quality of care delivered by renal units to CKD patients be systematically monitored and evaluated. The Italian Society of Nephrology (SIN) has started an initiative aimed at promoting a quality certification process specifically focused on CKD. To this end, SIN started a collaboration with an independent Italian company which is a partner of Joint Commission International (JCI), a nonprofit international organisation dedicated to the promotion of quality improvement and safety of health services. As a result of this collaboration, a document describing a voluntary certification process developed based on JCI criteria was produced by SIN. This document comprises 2 parts. Herein (Part I) we deal with standards for clinical care delivery and performance measurements related to CKD care. Programme management and clinical information management will be presented in a separate manuscript (Part II).

  3. Methodology for Developing Evidence-Based Clinical Imaging Guidelines: Joint Recommendations by Korean Society of Radiology and National Evidence-Based Healthcare Collaborating Agency

    PubMed Central

    Choi, Sol Ji; Jeong, Woo Kyoung; Jo, Ae Jeong; Choi, Jin A; Kim, Min-Jeong; Lee, Min; Jung, Seung Eun; Do, Kyung Hyun; Yong, Hwan Seok; Sheen, Seungsoo

    2017-01-01

    This paper is a summary of the methodology including protocol used to develop evidence-based clinical imaging guidelines (CIGs) in Korea, led by the Korean Society of Radiology and the National Evidence-based Healthcare Collaborating Agency. This is the first protocol to reflect the process of developing diagnostic guidelines in Korea. The development protocol is largely divided into the following sections: set-up, process of adaptation, and finalization. The working group is composed of clinical imaging experts, and the developmental committee is composed of multidisciplinary experts to validate the methodology. The Korean CIGs will continue to develop based on this protocol, and these guidelines will act for decision supporting tools for clinicians as well as reduce medical radiation exposure. PMID:28096730

  4. High-priority topics for cancer quality measure development: results of the 2012 American Society of Clinical Oncology Collaborative Cancer Measure Summit.

    PubMed

    Hassett, Michael J; McNiff, Kristen K; Dicker, Adam P; Gilligan, Timothy; Hendricks, Carolyn B; Lennes, Inga; Murray, Thomas; Krzyzanowska, Monika K

    2014-05-01

    Most cancer quality measures focus on individual cancers, assess specific providers, and evaluate processes of care. Although important, these efforts are not sufficient. A more comprehensive measure set is needed to address gaps in care, focus on patients rather than providers, and assess the cross-cutting aspects of care that are relevant to all patients with cancer throughout the trajectory of their illness. With the long-term goal of developing a more comprehensive oncology measure set, the American Society of Clinical Oncology (ASCO) organized a collaborative measure summit that used an iterative consensus approach to identify priorities for the development of new cancer quality measures. The summit, which included professional societies and patient/consumer advocacy organizations, was held during the ASCO Quality Care Symposium in December 2012. This effort, which brought together 12 diverse stakeholders, identified 10 high-priority topics for cancer quality measure development that cross-cut cancer diagnoses and care settings and addressed patient-centered concerns. Topics of particular interest included planning and counseling before therapy, interdisciplinary and multidisciplinary coordinated care, comprehensive symptom assessment, patient experience of care, and use of palliative care and hospice services. This is an important first step in the development of patient-centered, cross-cutting cancer quality measures. Addressing the high-priority topics identified by this effort will help fill the gaps left by existing cancer quality measures, including care coordination and transitions, quality of life, safety, experience of care, and outcomes. More work will be needed to specify, implement, and validate measures based on these topics. Copyright © 2014 by American Society of Clinical Oncology.

  5. Success of an International Learning Health Care System in Hematopoietic Cell Transplantation: The American Society of Blood and Marrow Transplantation Clinical Case Forum.

    PubMed

    Barba, Pere; Burns, Linda J; Litzow, Mark R; Juckett, Mark B; Komanduri, Krishna V; Lee, Stephanie J; Devlin, Sean M; Costa, Luciano J; Khan, Shakila; King, Andrea; Klein, Andreas; Krishnan, Amrita; Malone, Adriana; Mir, Muhammad; Moravec, Carina; Selby, George; Roy, Vivek; Cochran, Melissa; Stricherz, Melisa K; Westmoreland, Michael D; Perales, Miguel-Angel; Wood, William A

    2016-03-01

    The American Society for Blood and Marrow Transplantation (ASBMT) Clinical Case Forum (CCF) was launched in 2014 as an online secure tool to enhance interaction and communication among hematopoietic cell transplantation (HCT) professionals worldwide through the discussion of challenging clinical care issues. After 14 months, we reviewed clinical and demographical data of cases posted in the CCF from January 29, 2014 to March 18, 2015. A total of 137 cases were posted during the study period. Ninety-two cases (67%) were allogeneic HCT, 29 (21%) were autologous HCT, and in 16 (12%), the type of transplantation (autologous versus allogeneic) was still under consideration. The diseases most frequently discussed included non-Hodgkin lymphoma (NHL; n = 30, 22%), acute myeloid leukemia (n = 23, 17%), and multiple myeloma (MM; n = 20, 15%). When compared with the US transplantation activity reported by the US Department of Health and Human Services, NHL and acute lymphoblastic leukemia cases were over-represented in the CCF, whereas MM was under-represented (P < .001). A total of 259 topics were addressed in the CCF with a median of 2 topics/case (range, 1 to 6). Particularly common topics included whether transplantation was indicated (n = 57, 41%), conditioning regimen choice (n = 44, 32%), and post-HCT complications after day 100 (n = 43, 31%). The ASBMT CCF is a successful tool for collaborative discussion of complex cases in the HCT community worldwide and may allow identification of areas of controversy or unmet need from clinical, educational and research perspectives. Copyright © 2016 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

  6. Changing the brain, changing the society: clinical and ethical implications of neuromodulation techniques in neurology and psychiatry.

    PubMed

    Vuilleumier, Patrik; Sander, David; Baertschi, Bernard

    2014-01-01

    New neurotechnologies for modulating brain functions are becoming increasingly powerful and applicable to diverse diseases, but raise new questions for clinicians, ethicists, policy makers, and laymen. This issue of Brain Topography gathers several papers exploring the clinical and ethical implications of several invasive and noninvasive neuromodulation approaches. The opportunities and challenges associated with the emergence of neuro-engineering solutions to brain research and brain repair require a close dialogue between multiple disciplines, as well as open discussion with the general public.

  7. An Official American Thoracic Society Clinical Practice Guideline: Classification, Evaluation, and Management of Childhood Interstitial Lung Disease in Infancy

    PubMed Central

    Kurland, Geoffrey; Deterding, Robin R.; Hagood, James S.; Young, Lisa R.; Brody, Alan S.; Castile, Robert G.; Dell, Sharon; Fan, Leland L.; Hamvas, Aaron; Hilman, Bettina C.; Langston, Claire; Nogee, Lawrence M.; Redding, Gregory J.

    2013-01-01

    Background: There is growing recognition and understanding of the entities that cause interstitial lung disease (ILD) in infants. These entities are distinct from those that cause ILD in older children and adults. Methods: A multidisciplinary panel was convened to develop evidence-based guidelines on the classification, diagnosis, and management of ILD in children, focusing on neonates and infants under 2 years of age. Recommendations were formulated using a systematic approach. Outcomes considered important included the accuracy of the diagnostic evaluation, complications of delayed or incorrect diagnosis, psychosocial complications affecting the patient’s or family’s quality of life, and death. Results: No controlled clinical trials were identified. Therefore, observational evidence and clinical experience informed judgments. These guidelines: (1) describe the clinical characteristics of neonates and infants (<2 yr of age) with diffuse lung disease (DLD); (2) list the common causes of DLD that should be eliminated during the evaluation of neonates and infants with DLD; (3) recommend methods for further clinical investigation of the remaining infants, who are regarded as having “childhood ILD syndrome”; (4) describe a new pathologic classification scheme of DLD in infants; (5) outline supportive and continuing care; and (6) suggest areas for future research. Conclusions: After common causes of DLD are excluded, neonates and infants with childhood ILD syndrome should be evaluated by a knowledgeable subspecialist. The evaluation may include echocardiography, controlled ventilation high-resolution computed tomography, infant pulmonary function testing, bronchoscopy with bronchoalveolar lavage, genetic testing, and/or lung biopsy. Preventive care, family education, and support are essential. PMID:23905526

  8. Optical principles, biomechanics, and initial clinical performance of a dual-optic accommodating intraocular lens (an American Ophthalmological Society thesis).

    PubMed

    McLeod, Stephen D

    2006-01-01

    To design and develop an accommodating intraocular lens (IOL) for endocapsular fixation with extended accommodative range that can be adapted to current standard extracapsular phacoemulsification technique. Ray tracing analysis and lens design; finite element modeling of biomechanical properties; cadaver eye implantation; initial clinical evaluation. Ray tracing analysis indicated that a dual-optic design with a high plus-power front optic coupled to an optically compensatory minus posterior optic produced greater change in conjugation power of the eye compared to that produced by axial movement of a single-optic IOL, and that magnification effects were unlikely to account for improved near vision. Finite element modeling indicated that the two optics can be linked by spring-loaded haptics that allow anterior and posterior axial displacement of the front optic in response to changes in ciliary body tone and capsular tension. A dual-optic single-piece foldable silicone lens was constructed based on these principles. Subsequent initial clinical evaluation in 24 human eyes after phacoemulsification for cataract indicated mean 3.22 diopters of accommodation (range, 1 to 5 D) based on defocus curve measurement. Accommodative amplitude evaluation at 1- and 6-month follow-up in all eyes indicated that the accommodative range was maintained and that the lens was well tolerated. A dual-optic design increases the accommodative effect of axial optic displacement, with minimal magnification effect. Initial clinical trials suggest that IOLs designed on this principle might provide true pseudophakic accommodation following cataract extraction and lens implantation.

  9. Statistical Cluster Analysis of the British Thoracic Society Severe Refractory Asthma Registry: Clinical Outcomes and Phenotype Stability

    PubMed Central

    Newby, Chris; Heaney, Liam G.; Menzies-Gow, Andrew; Niven, Rob M.; Mansur, Adel; Bucknall, Christine; Chaudhuri, Rekha; Thompson, John; Burton, Paul; Brightling, Chris

    2014-01-01

    Background Severe refractory asthma is a heterogeneous disease. We sought to determine statistical clusters from the British Thoracic Society Severe refractory Asthma Registry and to examine cluster-specific outcomes and stability. Methods Factor analysis and statistical cluster modelling was undertaken to determine the number of clusters and their membership (N = 349). Cluster-specific outcomes were assessed after a median follow-up of 3 years. A classifier was programmed to determine cluster stability and was validated in an independent cohort of new patients recruited to the registry (n = 245). Findings Five clusters were identified. Cluster 1 (34%) were atopic with early onset disease, cluster 2 (21%) were obese with late onset disease, cluster 3 (15%) had the least severe disease, cluster 4 (15%) were the eosinophilic with late onset disease and cluster 5 (15%) had significant fixed airflow obstruction. At follow-up, the proportion of subjects treated with oral corticosteroids increased in all groups with an increase in body mass index. Exacerbation frequency decreased significantly in clusters 1, 2 and 4 and was associated with a significant fall in the peripheral blood eosinophil count in clusters 2 and 4. Stability of cluster membership at follow-up was 52% for the whole group with stability being best in cluster 2 (71%) and worst in cluster 4 (25%). In an independent validation cohort, the classifier identified the same 5 clusters with similar patient distribution and characteristics. Interpretation Statistical cluster analysis can identify distinct phenotypes with specific outcomes. Cluster membership can be determined using a classifier, but when treatment is optimised, cluster stability is poor. PMID:25058007

  10. Statistical cluster analysis of the British Thoracic Society Severe refractory Asthma Registry: clinical outcomes and phenotype stability.

    PubMed

    Newby, Chris; Heaney, Liam G; Menzies-Gow, Andrew; Niven, Rob M; Mansur, Adel; Bucknall, Christine; Chaudhuri, Rekha; Thompson, John; Burton, Paul; Brightling, Chris

    2014-01-01

    Severe refractory asthma is a heterogeneous disease. We sought to determine statistical clusters from the British Thoracic Society Severe refractory Asthma Registry and to examine cluster-specific outcomes and stability. Factor analysis and statistical cluster modelling was undertaken to determine the number of clusters and their membership (N = 349). Cluster-specific outcomes were assessed after a median follow-up of 3 years. A classifier was programmed to determine cluster stability and was validated in an independent cohort of new patients recruited to the registry (n = 245). Five clusters were identified. Cluster 1 (34%) were atopic with early onset disease, cluster 2 (21%) were obese with late onset disease, cluster 3 (15%) had the least severe disease, cluster 4 (15%) were the eosinophilic with late onset disease and cluster 5 (15%) had significant fixed airflow obstruction. At follow-up, the proportion of subjects treated with oral corticosteroids increased in all groups with an increase in body mass index. Exacerbation frequency decreased significantly in clusters 1, 2 and 4 and was associated with a significant fall in the peripheral blood eosinophil count in clusters 2 and 4. Stability of cluster membership at follow-up was 52% for the whole group with stability being best in cluster 2 (71%) and worst in cluster 4 (25%). In an independent validation cohort, the classifier identified the same 5 clusters with similar patient distribution and characteristics. Statistical cluster analysis can identify distinct phenotypes with specific outcomes. Cluster membership can be determined using a classifier, but when treatment is optimised, cluster stability is poor.

  11. OPTICAL PRINCIPLES, BIOMECHANICS, AND INITIAL CLINICAL PERFORMANCE OF A DUAL-OPTIC ACCOMMODATING INTRAOCULAR LENS (AN AMERICAN OPHTHALMOLOGICAL SOCIETY THESIS)

    PubMed Central

    McLeod, Stephen D.

    2006-01-01

    Purpose To design and develop an accommodating intraocular lens (IOL) for endocapsular fixation with extended accommodative range that can be adapted to current standard extracapsular phacoemulsification technique. Methods Ray tracing analysis and lens design; finite element modeling of biomechanical properties; cadaver eye implantation; initial clinical evaluation. Results Ray tracing analysis indicated that a dual-optic design with a high plus-power front optic coupled to an optically compensatory minus posterior optic produced greater change in conjugation power of the eye compared to that produced by axial movement of a single-optic IOL, and that magnification effects were unlikely to account for improved near vision. Finite element modeling indicated that the two optics can be linked by spring-loaded haptics that allow anterior and posterior axial displacement of the front optic in response to changes in ciliary body tone and capsular tension. A dual-optic single-piece foldable silicone lens was constructed based on these principles. Subsequent initial clinical evaluation in 24 human eyes after phacoemulsification for cataract indicated mean 3.22 diopters of accommodation (range, 1 to 5 D) based on defocus curve measurement. Accommodative amplitude evaluation at 1- and 6-month follow-up in all eyes indicated that the accommodative range was maintained and that the lens was well tolerated. Conclusions A dual-optic design increases the accommodative effect of axial optic displacement, with minimal magnification effect. Initial clinical trials suggest that IOLs designed on this principle might provide true pseudophakic accommodation following cataract extraction and lens implantation. PMID:17471355

  12. [Home childbirth and clinical delivery in the 3d Reich. On a memorial to the German Society of Gynecology 1939].

    PubMed

    Zander, J; Goetz, E

    1985-12-01

    There have always been controversies on the pros and cons of home delivery and childbirth in a hospital. During the Nazi regime, the official "health command" policy monitored by the Nazi party promoted home delivery under midwife supervision, both by pertinacious propaganda and partly also by decrees and ordinances. The official line of argument against clinical obstetrics consisted of a queer and highly questionable mélange of ideology and distored facts brought forward by the so-called "Reichsgesundheitsführer" Dr. Leonardo Conti and his mother, Mrs Nanna Conti as head of the Party-sponsored Midwives Association. The "Midwives Law" was promulgated on 21 December 1938 prescribing compulsory consultation of a midwife for every delivery. By the end of 1939 gynaecologists eventually rallied in protest against legislative measures to restrict clinical obstetrics, by means of a memorandum penned by the German Association for Gynaecology. This memorandum was scheduled for circulation among all the members of the association. The pressure exercised by this memorandum resulted in tough negotiations amounting to a tug-of-war between representatives of the German Association for Gynaecology and Dr. Conti. This led eventually not only to an abandonment of the attacks against clinical obstetrics but also to an official and unreserved recognition of its achievements. In addition, the "Reichsgesundheitsführer" issued "Directives for regulating obstetrics procedures" in 1940/41 in which it was laid down that it would be left to the decision of the expectant mother to choose where she would prefer to deliver her child.

  13. The American Society for Clinical Pathology resident in-service examination: does resident performance provide insight into the effectiveness of clinical pathology education?

    PubMed

    McKenna, Barbara J

    2007-06-01

    The resident in-service examination in pathology is an in-training exercise that is taken by virtually all pathology residents in the United States as well as by some participants in Canada, Ireland, and Lebanon. Although all of the anatomic pathology topics in the examination, with only one exception-forensic pathology, show significant improvement in scores over the 4 years of residency training, three areas of clinical pathology training (laboratory administration, clinical chemistry, and microbiology) show significantly lower improvement in performance over the years of residency training. By contrast, transfusion medicine, hematopathology and the special topics section of the examination all demonstrate improved performance by residents over time. While the reason behind these differences must remain speculative at this time, these findings suggest that measures to improve effectiveness in clinical pathology training might be suggested by examining the differences between residency training practices between higher and lower performing areas of clinical pathology.

  14. CLINICAL PRACTICE GUIDELINES FOR THE PERIOPERATIVE NUTRITIONAL, METABOLIC, AND NONSURGICAL SUPPORT OF THE BARIATRIC SURGERY PATIENT—2013 UPDATE: COSPONSORED BY AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS, THE OBESITY SOCIETY, AND AMERICAN SOCIETY FOR METABOLIC & BARIATRIC SURGERY★

    PubMed Central

    Mechanick, Jeffrey I.; Youdim, Adrienne; Jones, Daniel B.; Garvey, W. Timothy; Hurley, Daniel L.; McMahon, M. Molly; Heinberg, Leslie J.; Kushner, Robert; Adams, Ted D.; Shikora, Scott; Dixon, John B.; Brethauer, Stacy

    2014-01-01

    The development of these updated guidelines was commissioned by the AACE, TOS, and ASMBS Board of Directors and adheres to the AACE 2010 protocol for standardized production of clinical practice guidelines (CPG). Each recommendation was re-evaluated and updated based on the evidence and subjective factors per protocol. Examples of expanded topics in this update include: the roles of sleeve gastrectomy, bariatric surgery in patients with type-2 diabetes, bariatric surgery for patients with mild obesity, copper deficiency, informed consent, and behavioral issues. There are 74 recommendations (of which 56 are revised and 2 are new) in this 2013 update, compared with 164 original recommendations in 2008. There are 403 citations, of which 33 (8.2%) are EL 1, 131 (32.5%) are EL 2, 170 (42.2%) are EL 3, and 69 (17.1%) are EL 4. There is a relatively high proportion (40.4%) of strong (EL 1 and 2) studies, compared with only 16.5% in the 2008 AACE- TOS-ASMBS CPG. These updated guidelines reflect recent additions to the evidence base. Bariatric surgery remains a safe and effective intervention for select patients with obesity. A team approach to perioperative care is mandatory with special attention to nutritional and metabolic issues. PMID:23529351

  15. Clinical Practice Guidelines for the Perioperative Nutritional, Metabolic, and Nonsurgical Support of the Bariatric Surgery Patient—2013 Update: Cosponsored by American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery*

    PubMed Central

    Mechanick, Jeffrey I.; Youdim, Adrienne; Jones, Daniel B.; Garvey, W. Timothy; Hurley, Daniel L.; McMahon, Molly; Heinberg, Leslie J.; Kushner, Robert; Adams, Ted D.; Shikora, Scott; Dixon, John B.; Brethauer, Stacy

    2014-01-01

    The development of these updated guidelines was commissioned by the AACE, TOS, and ASMBS Board of Directors and adheres to the AACE 2010 protocol for standardized production of clinical practice guidelines (CPG). Each recommendation was re-evaluated and updated based on the evidence and subjective factors per protocol. Examples of expanded topics in this update include: the roles of sleeve gastrectomy, bariatric surgery in patients with type-2 diabetes, bariatric surgery for patients with mild obesity, copper deficiency, informed consent, and behavioral issues. There are 74 recommendations (of which 56 are revised and 2 are new) in this 2013 update, compared with 164 original recommendations in 2008. There are 403 citations, of which 33 (8.2%) are EL 1, 131 (32.5%) are EL 2, 170 (42.2%) are EL 3, and 69 (17.1%) are EL 4. There is a relatively high proportion (40.4%) of strong (EL 1 and 2) studies, compared with only 16.5% in the 2008 AACE-TOS-ASMBS CPG. These updated guidelines reflect recent additions to the evidence base. Bariatric surgery remains a safe and effective intervention for select patients with obesity. A team approach to perioperative care is mandatory with special attention to nutritional and metabolic issues. PMID:23529939

  16. [Consensus for antimicrobial susceptibility testing for Enterobacteriaceae. Subcommittee on Antimicrobials, SADEBAC (Argentinian Society of Clinical Bacteriology), Argentinian Association of Microbiology].

    PubMed

    Famiglietti, A; Quinteros, M; Vázquez, M; Marín, M; Nicola, F; Radice, M; Galas, M; Pasterán, F; Bantar, C; Casellas, J M; Kovensky Pupko, J; Couto, E; Goldberg, M; Lopardo, H; Gutkind, G; Soloaga, R

    2005-01-01

    Taking into account previous recommendations from the National Committee for Clinical Laboratory Standards (NCCLS), the Antimicrobial Committee, Sociedad Argentina de Bacteriología Clínica (SADEBAC), Asociación Argentina de Microbiología (AAM), and the experience from its members and some invited microbiologists, a consensus was obtained for antimicrobial susceptibility testing and interpretation in most frequent enterobacterial species isolated from clinical samples in our region. This document describes the natural antimicrobial resistance of some Enterobacteriaceae family members, including the resistance profiles due to their own chromosomal encoded beta-lactamases. A list of the antimicrobial agents that should be tested, their position on the agar plates, in order to detect the most frequent antimicrobial resistance mechanisms, and considerations on which antimicrobial agents should be reported regarding to the infection site and patient characteristics are included. Also, a description on appropriate phenotypic screening and confirmatory test for detection of prevalent extended spectrum beta-lactamases in our region are presented. Finally, a summary on frequent antimicrobial susceptibility profiles and their probably associated resistance mechanisms, and some infrequent antimicrobial resistance profiles that deserve confirmation are outlined.

  17. Use of Nebulized Antimicrobials for the Treatment of Respiratory Infections in Invasively Mechanically Ventilated Adults: A Position Paper from the European Society of Clinical Microbiology and Infectious Diseases.

    PubMed

    Rello, Jordi; Solé-Lleonart, Candela; Rouby, Jean-Jacques; Chastre, Jean; Blot, Stijn; Poulakou, Garyfallia; Luyt, Charles-Edouard; Riera, Jordi; Palmer, Lucy B; Pereira, Jose M; Felton, Tim; Dhanani, Jayesh; Bassetti, Matteo; Welte, Tobias; Roberts, Jason A

    2017-04-13

    With an established role in cystic fibrosis and bronchiectasis, nebulized antibiotics are increasingly being used to treat respiratory infections in critically ill invasively mechanically ventilated adult patients. Although there is limited evidence describing their efficacy and safety, in an era of need for new strategies to enhance antibiotic effectiveness because of a shortage of new agents and increases in antibiotic resistance, the potential of nebulization of antibiotics to optimize therapy is considered of high interest, particularly in patients infected with multidrug-resistant (MDR) pathogens. This Position Paper of the European Society of Clinical Microbiology and Infectious Diseases provides recommendations based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology regarding the use of nebulized antibiotics in invasively mechanically ventilated adults, based on a systematic review and meta-analysis of the existing literature (last search July 2016). Overall, the panel recommends to avoid use of nebulized antibiotics in clinical practice, due to a weak level of evidence of their efficacy and the high potential for underestimated risks of adverse events (particularly, respiratory complications). Higher quality evidence is urgently needed to inform clinical practice. Priorities of future research are detailed in the second part of the Position Paper as a guidance for researchers in this field. In particular, the panel identified an urgent need for randomized clinical trials of nebulized antibiotic therapy as part of a substitution approach to treatment of pneumonia due to MDR pathogens.

  18. Choosing wisely in Allergology: a Slow Medicine approach to the discipline promoted by the Italian Society of Allergy, Asthma and Clinical Immunology (SIAAIC).

    PubMed

    Heffler, Enrico; Landi, Massimo; Quadrino, Silvana; Incorvaia, Cristoforo; Pizzimenti, Stefano; Vernero, Sandra; Crimi, Nunzio; Rolla, Giovanni; Canonica, Giorgio Walter

    2015-01-01

    One of the main problem health care systems are facis is the mis-use and over-use of medical resources (including useless exams, surgical interventions, medical treatments, screening procedures…) which may lead to high health care related costs without increased patients' benefit and possible harm to the patients themselves. The "Choosing wisely" campaign, in Italy denominated "Doing more does not mean doing better", tries to educate doctors and citizens at a correct use of medical resources. the Italian Society of Allergy, Asthma and Clinical Immunology (SIAAIC) adhered to the "Doing more does not mean doing better" campaing and made a list of the 5 allergological procedures with the highest evidence of inappropriateness. the 5 recommendations were: "Do not perform allergy tests for drugs (including anhestetics) and/or foods when there are neither clinical history nor symptoms suggestive of hypersensitivity reactions"; "Do not perform the so-called "food intolerance tests" (apart from those which are validated for suspect celiac disease or lactose enzymatic intolerance)"; "Do not perform serological allergy tests (i.e.: total IgE, specific IgE, ISAC) as first-line tests or as "screening" assays"; "Do not treat patients sensitized to allergens or aptens if there is not a clear correlation between exposure to that specific allergen/apten and symptoms suggestive of allergic reaction"; "Do not diagnose asthma without having performed lung function tests". An important role scientific societies should play is to advise on correct diagnostic and therapeutical pathways. For this reason SIAAIC decided to adhere to the Slow Medicine Italy campaign "Doing more does not mean doing better" with the aim of warning the scientific community and the citizens/patients about some allergological procedures, which, when performed in the wrong clinical setting, may be not only useless, but unnecessarily expensive and even harmful for patients' health.

  19. Modernizing Clinical Trial Eligibility: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research Minimum Age Working Group.

    PubMed

    Gore, Lia; Ivy, S Percy; Balis, Frank M; Rubin, Eric; Thornton, Katherine; Donoghue, Martha; Roberts, Samantha; Bruinooge, Suanna; Ersek, Jennifer; Goodman, Nancy; Schenkel, Caroline; Reaman, Gregory

    2017-10-02

    Purpose Children have historically been excluded from first-in-human studies of promising new cancer drugs and later phase adult clinical trials. Delays in evaluation may result in off-label use without dosing information as the only access to new drugs. A multistakeholder workshop was convened in May 2016 by ASCO and Friends of Cancer Research to identify opportunities for when it would be scientifically appropriate to expand trial eligibility to include children younger than age 18 years in first-in-human and other adult cancer clinical trials. Methods This group convened experts from academia, government, and industry to review barriers to enrolling children and adolescents in oncology clinical trials. We evaluated the historical context, published literature, regulatory considerations, and myriad risks and benefits associated with lowering the age of enrollment on oncology clinical trials. Results We conclude that many of the historical concerns about including children early in oncology clinical trials do not apply in the current scientific and clinical environment of pediatric oncology and drug development; we provide specific recommendations for how the inclusion of children in early-phase investigational cancer drug trials might be accomplished. Automatic inclusion of pediatric patients is appropriate in early-phase trials that assess dose, safety, and pharmacokinetics in a variety of tumor types and later phase trials that assess efficacy in a specific disease that spans adult and pediatric populations. Conclusion Including children in appropriately designed adult clinical oncology trials is feasible and can be done in a way that enhances their access to these agents without compromising safety or development strategies.

  20. Dog-bite injuries at the Animal Bite Clinic of the Thai Red Cross Society in Bangkok.

    PubMed

    Mitmoonpitak, C; Tepsumethanon, V; Raksaket, S; Nayuthaya, A B; Wilde, H

    2000-12-01

    Canine rabies remains a public health problem in Thailand and other developing countries. This study of animal bites at the Animal Bite Clinic at the Queen Saovabha Memorial Institute revealed that: (1) The majority of patients were bitten by dogs and the time of the attack was mostly during the day. (2) School-aged children are at the highest risk for animal bites. (3) The most common site of injury are the legs and foot (64.2%), with the second most common site being the hands and fingers (21.2%). (4) Only 48 per cent of patients received rabies vaccine 1-2 days after being exposed. There was considerable delay before the rest received treatment. Solving Thailand' s rabies problem depends on control of canine rabies and educational campaigns. Public education must be an integral part of efforts to decrease the incidence of animal bites and assurance that they are managed properly.

  1. International Cartilage Repair Society (ICRS) Recommended Guidelines for Histological Endpoints for Cartilage Repair Studies in Animal Models and Clinical Trials

    PubMed Central

    Hoemann, Caroline; Kandel, Rita; Roberts, Sally; Saris, Daniel B.F.; Creemers, Laura; Mainil-Varlet, Pierre; Méthot, Stephane; Hollander, Anthony P.; Buschmann, Michael D.

    2011-01-01

    Cartilage repair strategies aim to resurface a lesion with osteochondral tissue resembling native cartilage, but a variety of repair tissues are usually observed. Histology is an important structural outcome that could serve as an interim measure of efficacy in randomized controlled clinical studies. The purpose of this article is to propose guidelines for standardized histoprocessing and unbiased evaluation of animal tissues and human biopsies. Methods were compiled from a literature review, and illustrative data were added. In animal models, treatments are usually administered to acute defects created in healthy tissues, and the entire joint can be analyzed at multiple postoperative time points. In human clinical therapy, treatments are applied to developed lesions, and biopsies are obtained, usually from a subset of patients, at a specific time point. In striving to standardize evaluation of structural endpoints in cartilage repair studies, 5 variables should be controlled: 1) location of biopsy/sample section, 2) timing of biopsy/sample recovery, 3) histoprocessing, 4) staining, and 5) blinded evaluation with a proper control group. Histological scores, quantitative histomorphometry of repair tissue thickness, percentage of tissue staining for collagens and glycosaminoglycan, polarized light microscopy for collagen fibril organization, and subchondral bone integration/structure are all relevant outcome measures that can be collected and used to assess the efficacy of novel therapeutics. Standardized histology methods could improve statistical analyses, help interpret and validate noninvasive imaging outcomes, and permit cross-comparison between studies. Currently, there are no suitable substitutes for histology in evaluating repair tissue quality and cartilaginous character. PMID:26069577

  2. American Society of Biomechanics Clinical Biomechanics Award 2012: plantar shear stress distributions in diabetic patients with and without neuropathy.

    PubMed

    Yavuz, Metin

    2014-02-01

    The exact pathology of diabetic foot ulcers remains to be resolved. Evidence suggests that plantar shear forces play a major role in diabetic ulceration. Unfortunately, only a few manuscripts exist on the clinical implications of plantar shear. The purpose of this study was to compare global and regional peak plantar stress values in three groups; diabetic patients with neuropathy, diabetic patients without neuropathy and healthy control subjects. Fourteen diabetic neuropathic patients, 14 non-neuropathic diabetic control and 11 non-diabetic control subjects were recruited. Subjects walked on a custom-built stress plate that quantified plantar pressures and shear. Four stress variables were analyzed; peak pressure, peak shear, peak pressure-time and shear-time integral. Global peak values of peak shear (p = 0.039), shear-time integral (p = 0.002) and pressure-time integral (p = 0.003) were significantly higher in the diabetic neuropathic group. The local peak shear stress and shear-time integral were also significantly higher in diabetic neuropathic patients compared to both control groups, in particular, at the hallux and central forefoot. The local peak pressure and pressure-time integral were significantly different between the three groups at the medial and lateral forefoot. Plantar shear and shear-time integral magnitudes were elevated in diabetic patients with peripheral neuropathy, which indicates the potential clinical significance of these factors in ulceration. It is thought that further investigation of plantar shear would lead to a better understanding of ulceration pathomechanics, which in turn will assist researchers in developing more effective preventive devices and strategies. Copyright © 2013 Elsevier Ltd. All rights reserved.

  3. Standards for ambulatory blood pressure monitoring clinical reporting in daily practice: recommendations from the Italian Society of Hypertension.

    PubMed

    Omboni, Stefano; Palatini, Paolo; Parati, Gianfranco

    2015-10-01

    This paper aims to provide practical indications to healthcare professionals and manufacturers of ambulatory blood pressure monitoring (ABPM) devices on the characteristics and minimum required contents of a standard ABPM report to be used in the clinical practice. Such indications will help make ABPM reports more easily interpretable and independent from the ABPM device and software used. The first important and unavoidable step of ABPM reporting is a quality assessment: if a recording does not meet the minimum requirements for quality criteria, the reporting physician should advise the patient to repeat the test and should not further proceed to a diagnostic evaluation and interpretation of the recording. A basic clinical report must contain the list of each single reading, the graphical display of individual readings and hourly average values, the mean, minimum and maximum values, and SDs of blood pressure and heart rate values for the 24 h, daytime and night-time, day-night differences, and blood pressure loads. The final medical report should be prepared in a quite logically structured way, considering the following: (i) a judgment on the overall quality of the 24 h recording; (ii) an indication of whether average 24 h, daytime and night-time systolic, and diastolic blood pressure values are within or above the normal limits; and (iii) a description of the 24 h pattern of blood pressure fluctuations. A final general statement on the normotensive or hypertensive status and on the degree of blood pressure control in case of treated patients should also be provided.

  4. [Pre-analytical quality in fluid samples cytopathology: Results of a survey from the French Society of Clinical Cytology].

    PubMed

    Courtade-Saïdi, Monique; Fleury Feith, Jocelyne

    2015-10-01

    The pre-analytical step includes sample collection, preparation, transportation and storage in the pathology unit where the diagnosis is performed. The pathologist ensures that pre-analytical conditions are in line with expectations. The lack of standardization for handling cytological samples makes this pre-analytical step difficult to harmonize. Moreover, this step depends on the nature of the sample: fresh liquid or fixed material, air-dried smears, liquid-based cytology. The aim of the study was to review the different practices in French structures of pathology on the pre-analytical phase concerning cytological fluids such as broncho-alveolar lavage (BALF), serous fluids and urine. A survey was conducted on the basis of the pre-analytical chapter of the ISO 15189 and sent to 191 French pathological structures (105 public and 86 private). Fifty-six laboratories replied to the survey. Ninety-five per cent have a computerized management system and 70% a manual on sample handling. The general instructions requested for the patients and sample identification were highly correctly filled with a short time routing and additional tests prescription. By contrast, information are variable concerning the clinical information requested and the type of tubes for collecting fluids and the volumes required as well as the actions taken in case of non-conformity. For the specific items concerning BALF, serous fluids and urine, this survey has shown a great heterogeneity according to sample collection, fixation and of clinical information. This survey demonstrates that the pre-analytical quality for BALF, serous fluids and urine is not optimal and that some corrections of the practices are recommended with a standardization of numerous steps in order to increase the reproducibility of additional tests such as immunocytochemistry, cytogenetic and molecular biology. Some recommendations have been written. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  5. [Present Execution of and Problems with Clinical Lipid Examination and Application of "the Japan Atherosclerotic Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012"].

    PubMed

    Igarashi, Masahiko; Tanji, Yasuhiro; Nomura, Takashi; Yamaguchi, Hiroshi

    2014-09-01

    It is well known that dyslipidemia is one of the most crucial risk factors for atherosclerosis, including cardiovascular diseases (ASCVD). In order to prevent the onset of ASCVD, the Japan Atherosclerotic Society (JAS) published the JAS Guidelines in 2012 for appropriate lipid examination and treatment. However, it is unknown how the guidelines are practically used by Japanese clinicians. Therefore, we conducted a questionnaire survey to assess the present execution of and problems with clinical lipid examination and the application of the JAS Guidelines by doctors working in hospitals and clinics of Yamagata district in Japan. We found that 16% of doctors carried out clinical lipid examination every time, but some did not examine lipids at all. Fasting blood sampling for lipid examination was performed by 44% of doctors, and the items of triglycerides, HDL-cholesterol (HDL-C), and LDL-cholesterol (LDL-C) were measured by more than 95%. Regarding problems with clinical lipid examination, more than 40% of doctors requested the early achievement of the standardization of LDL-C. The JAS Guidelines in 2012 were unfortunately recognized by only 55% of doctors. In addition, the rate of the clinical application of the guidelines, including the absolute risk, the flowchart of LDL-C, and non-HDL-C, was less than 30%, and more than half of the doctors measured LDL-C with the direct method, but did not use the "recommended" Friedewald method. In contrast, the cardiologists and endocrinologists generally accepted the guidelines, and their clinical application rate was higher than in other doctors. Through the questionnaire survey, it was revealed that doctors in various fields have not properly accepted the use and significance of lipid examination and the JAS Guidelines, and so further educational activities are necessary.

  6. American Society of Blood and Marrow Transplantation, European Society of Blood and Marrow Transplantation, Blood and Marrow Transplant Clinical Trials Network, and International Myeloma Working Group Consensus Conference on Salvage Hematopoietic Cell Transplantation in Patients with Relapsed Multiple Myeloma

    PubMed Central

    Giralt, Sergio; Garderet, Laurent; Durie, Brian; Cook, Gordon; Gahrton, Gosta; Bruno, Benedetto; Hari, Paremesweran; Lokhorst, Henk; McCarthy, Phillip; Krishnan, Amrita; Sonneveld, Pieter; Goldschmidt, Harmut; Jagannath, Sundar; Barlogie, Bart; Mateos, Maria; Gimsing, Peter; Sezer, Orhan; Mikhael, Joseph; Lu, Jin; Dimopoulos, Meletios; Mazumder, Amitabha; Palumbo, Antonio; Abonour, Rafat; Anderson, Kenneth; Attal, Michel; Blade, Joan; Bird, Jenny; Cavo, Michele; Comenzo, Raymond; de la Rubia, Javier; Einsele, Hermann; Garcia-Sanz, Ramon; Hillengass, Jens; Holstein, Sarah; Johnsen, Hans Erik; Joshua, Douglas; Koehne, Guenther; Kumar, Shaji; Kyle, Robert; Leleu, Xavier; Lonial, Sagar; Ludwig, Heinz; Nahi, Hareth; Nooka, Anil; Orlowski, Robert; Rajkumar, Vincent; Reiman, Anthony; Richardson, Paul; Riva, Eloisa; Miguel, Jesus San; Turreson, Ingemar; Usmani, Saad; Vesole, David; Bensinger, William; Qazilbash, Muzaffer; Efebera, Yvonne; Mohty, Mohamed; Gasparreto, Christina; Gajewski, James; LeMaistre, Charles F.; Bredeson, Chris; Moreau, Phillipe; Pasquini, Marcelo; Kroeger, Nicolaus; Stadtmauer, Edward

    2016-01-01

    In contrast to the upfront setting in which the role of high-dose therapy with autologous hematopoietic cell transplantation (HCT) as consolidation of a first remission in patients with multiple myeloma (MM) is well established, the role of high-dose therapy with autologous or allogeneic HCT has not been extensively studied in MM patients relapsing after primary therapy. The International Myeloma Working Group together with the Blood and Marrow Transplant Clinical Trials Network, the American Society of Blood and Marrow Transplantation, and the European Society of Blood and Marrow Transplantation convened a meeting of MM experts to: (1) summarize current knowledge regarding the role of autologous or allogeneic HCT in MM patients progressing after primary therapy, (2) propose guidelines for the use of salvage HCT in MM, (3) identify knowledge gaps, (4) propose a research agenda, and (5) develop a collaborative initiative to move the research agenda forward. After reviewing the available data, the expert committee came to the following consensus statement for salvage autologous HCT: (1) In transplantation-eligible patients relapsing after primary therapy that did NOT include an autologous HCT, high-dose therapy with HCT as part of salvage therapy should be considered standard; (2) High-dose therapy and autologous HCT should be considered appropriate therapy for any patients relapsing after primary therapy that includes an autologous HCT with initial remission duration of more than 18 months; (3) High-dose therapy and autologous HCT can be used as a bridging strategy to allogeneic HCT; (4) The role of postsalvage HCT maintenance needs to be explored in the context of well-designed prospective trials that should include new agents, such as monoclonal antibodies, immune-modulating agents, and oral proteasome inhibitors; (5) Autologous HCT consolidation should be explored as a strategy to develop novel conditioning regimens or post-HCT strategies in patients with short

  7. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society.

    PubMed

    Qaseem, Amir; Wilt, Timothy J; Weinberger, Steven E; Hanania, Nicola A; Criner, Gerard; van der Molen, Thys; Marciniuk, Darcy D; Denberg, Tom; Schünemann, Holger; Wedzicha, Wisia; MacDonald, Roderick; Shekelle, Paul

    2011-08-02

    This guideline is an official statement of the American College of Physicians (ACP), American College of Chest Physicians (ACCP), American Thoracic Society (ATS), and European Respiratory Society (ERS). It represents an update of the 2007 ACP clinical practice guideline on diagnosis and management of stable chronic obstructive pulmonary disease (COPD) and is intended for clinicians who manage patients with COPD. This guideline addresses the value of history and physical examination for predicting airflow obstruction; the value of spirometry for screening or diagnosis of COPD; and COPD management strategies, specifically evaluation of various inhaled therapies (anticholinergics, long-acting β-agonists, and corticosteroids), pulmonary rehabilitation programs, and supplemental oxygen therapy. This guideline is based on a targeted literature update from March 2007 to December 2009 to evaluate the evidence and update the 2007 ACP clinical practice guideline on diagnosis and management of stable COPD. RECOMMENDATION 1: ACP, ACCP, ATS, and ERS recommend that spirometry should be obtained to diagnose airflow obstruction in patients with respiratory symptoms (Grade: strong recommendation, moderate-quality evidence). Spirometry should not be used to screen for airflow obstruction in individuals without respiratory symptoms (Grade: strong recommendation, moderate-quality evidence). RECOMMENDATION 2: For stable COPD patients with respiratory symptoms and FEV(1) between 60% and 80% predicted, ACP, ACCP, ATS, and ERS suggest that treatment with inhaled bronchodilators may be used (Grade: weak recommendation, low-quality evidence). RECOMMENDATION 3: For stable COPD patients with respiratory symptoms and FEV(1) <60% predicted, ACP, ACCP, ATS, and ERS recommend treatment with inhaled bronchodilators (Grade: strong recommendation, moderate-quality evidence). RECOMMENDATION 4: ACP, ACCP, ATS, and ERS recommend that clinicians prescribe monotherapy using either long-acting inhaled

  8. [Skin tests for diagnostics of allergic immediate-type reactions. Guideline of the German Society for Allergology and Clinical Immunology].

    PubMed

    Ruëff, F; Bergmann, K-C; Brockow, K; Fuchs, T; Grübl, A; Jung, K; Klimek, L; Müsken, H; Pfaar, O; Przybilla, B; Sitter, H; Wehrmann, W

    2011-08-01

    if the mean wheal diameter is ≥ 3 mm at the prick test, and ≥ 5 mm at the intradermal test.[nl]Skin test results may be negative although patients are allergic. If a skin test is positive, one will have to distinguish reactions, which are clinically relevant, from those, which are not. History and/or challenge tests help to clarify the relevance of a sensitization. Usually, a clinically irrelevant sensitization does not lead to practical consequences. © Georg Thieme Verlag KG Stuttgart · New York.

  9. Benchmarking progress in the implementation of the Fourth Joint Societies' Task Force Guidelines on the Prevention of Cardiovascular Disease in Clinical Practice.

    PubMed

    Morgan, Karen; Burke, Helen; McGee, Hannah

    2013-02-01

    The Fourth Joint Societies' Task Force (4th JTF) Guidelines on Cardiovascular Disease Prevention in Clinical Practice are agreed, evidence-based standards of care across European countries and professions. In advance of the publication of the 5th JTF Guidelines in 2012, this work assesses the extent to which the 4th JTF guidelines have been implemented. Qualitative study of guideline implementation in 13 European countries, focusing on the themes of guideline implementation structures, processes, and outcomes. Key personnel in 13 selected countries completed interviews or comparable questionnaires: they were national coordinators for CVD prevention (n = 14) and representatives of the national cardiac society (n = 9), heart foundations (n = 11), health ministry (n = 8), and service providers (n = 3). Interview and service-related data from each country were compiled to provide a detailed overview. Ten of the 13 countries used European Society of Cardiology (ESC) guidelines on prevention at a national level, where three broad approaches to implementation were identified. In all 10 countries, multidisciplinary alliances oversaw implementation, but ongoing promotion of the guidelines was not evident, with just two of the 10 countries conducting evaluation of implementation. Barriers to implementation included weak health authority support, the unwieldy nature of the guidelines, guideline fatigue, and the lesser role of prevention in national healthcare systems. Substantial progress had been made in implementing the guidelines, but countries struggled with the task. Some rebalancing of the ESC focus may be warranted so that part of the effort dedicated to improving guidelines might be redirected at translating them into practice.

  10. Optimizing pulmonary rehabilitation in chronic obstructive pulmonary disease--practical issues: a Canadian Thoracic Society Clinical Practice Guideline.

    PubMed

    Marciniuk, Darcy D; Brooks, Dina; Butcher, Scott; Debigare, Richard; Dechman, Gail; Ford, Gordon; Pepin, Veronique; Reid, Darlene; Sheel, Andrew W; Stickland, Micheal K; Todd, David C; Walker, Shannon L; Aaron, Shawn D; Balter, Meyer; Bourbeau, Jean; Hernandez, Paul; Maltais, Francois; O'Donnell, Denis E; Bleakney, Donna; Carlin, Brian; Goldstein, Roger; Muthuri, Stella K

    2010-01-01

    Pulmonary rehabilitation (PR) participation is the standard of care for patients with chronic obstructive pulmonary disease (COPD) who remain symptomatic despite bronchodilator therapies. However, there are questions about specific aspects of PR programming including optimal site of rehabilitation delivery, components of rehabilitation programming, duration of rehabilitation, target populations and timing of rehabilitation. The present document was compiled to specifically address these important clinical issues, using an evidence-based, systematic review process led by a representative interprofessional panel of experts. The evidence reveals there are no differences in major patient-related outcomes of PR between nonhospital- (community or home sites) or hospital-based sites. There is strong support to recommend that COPD patients initiate PR within one month following an acute exacerbation due to benefits of improved dyspnea, exercise tolerance and health-related quality of life relative to usual care. Moreover, the benefits of PR are evident in both men and women, and in patients with moderate, severe and very severe COPD. The current review also suggests that longer PR programs, beyond six to eight weeks duration, be provided for COPD patients, and that while aerobic training is the foundation of PR, endurance and functional ability may be further improved with both aerobic and resistance training.

  11. Managing dyspnea in patients with advanced chronic obstructive pulmonary disease: A Canadian Thoracic Society clinical practice guideline

    PubMed Central

    Marciniuk, Darcy D; Goodridge, Donna; Hernandez, Paul; Rocker, Graeme; Balter, Meyer; Bailey, Pat; Ford, Gordon; Bourbeau, Jean; O’Donnell, Denis E; Maltais, Francois; Mularski, Richard A; Cave, Andrew J; Mayers, Irvin; Kennedy, Vicki; Oliver, Thomas K; Brown, Candice

    2011-01-01

    Dyspnea is a cardinal symptom of chronic obstructive pulmonary disease (COPD), and its severity and magnitude increases as the disease progresses, leading to significant disability and a negative effect on quality of life. Refractory dyspnea is a common and difficult symptom to treat in patients with advanced COPD. There are many questions concerning optimal management and, specifically, whether various therapies are effective in this setting. The present document was compiled to address these important clinical issues using an evidence-based systematic review process led by a representative interprofessional panel of experts. The evidence supports the benefits of oral opioids, neuromuscular electrical stimulation, chest wall vibration, walking aids and pursed-lip breathing in the management of dyspnea in the individual patient with advanced COPD. Oxygen is recommended for COPD patients with resting hypoxemia, but its use for the targeted management of dyspnea in this setting should be reserved for patients who receive symptomatic benefit. There is insufficient evidence to support the routine use of anxiolytic medications, nebulized opioids, acupuncture, acupressure, distractive auditory stimuli (music), relaxation, hand-held fans, counselling programs or psychotherapy. There is also no evidence to support the use of supplemental oxygen to reduce dyspnea in nonhypoxemic patients with advanced COPD. Recognizing the current unfamiliarity with prescribing and dosing of opioid therapy in this setting, a potential approach for their use is illustrated. The role of opioid and other effective therapies in the comprehensive management of refractory dyspnea in patients with advanced COPD is discussed. PMID:21499589

  12. Managing dyspnea in patients with advanced chronic obstructive pulmonary disease: a Canadian Thoracic Society clinical practice guideline.

    PubMed

    Marciniuk, Darcy D; Goodridge, Donna; Hernandez, Paul; Rocker, Graeme; Balter, Meyer; Bailey, Pat; Ford, Gord; Bourbeau, Jean; O'Donnell, Denis E; Maltais, Francois; Mularski, Richard A; Cave, Andrew J; Mayers, Irvin; Kennedy, Vicki; Oliver, Thomas K; Brown, Candice

    2011-01-01

    Dyspnea is a cardinal symptom of chronic obstructive pulmonary disease (COPD), and its severity and magnitude increases as the disease progresses, leading to significant disability and a negative effect on quality of life. Refractory dyspnea is a common and difficult symptom to treat in patients with advanced COPD. There are many questions concerning optimal management and, specifically, whether various therapies are effective in this setting. The present document was compiled to address these important clinical issues using an evidence-based systematic review process led by a representative interprofessional panel of experts. The evidence supports the benefits of oral opioids, neuromuscular electrical stimulation, chest wall vibration, walking aids and pursed-lip breathing in the management of dyspnea in the individual patient with advanced COPD. Oxygen is recommended for COPD patients with resting hypoxemia, but its use for the targeted management of dyspnea in this setting should be reserved for patients who receive symptomatic benefit. There is insufficient evidence to support the routine use of anxiolytic medications, nebulized opioids, acupuncture, acupressure, distractive auditory stimuli (music), relaxation, handheld fans, counselling programs or psychotherapy. There is also no evidence to support the use of supplemental oxygen to reduce dyspnea in nonhypoxemic patients with advanced COPD. Recognizing the current unfamiliarity with prescribing and dosing of opioid therapy in this setting, a potential approach for their use is illustrated. The role of opioid and other effective therapies in the comprehensive management of refractory dyspnea in patients with advanced COPD is discussed.

  13. An official American Thoracic Society Clinical Practice guideline: the diagnosis of intensive care unit-acquired weakness in adults.

    PubMed

    Fan, Eddy; Cheek, Fern; Chlan, Linda; Gosselink, Rik; Hart, Nicholas; Herridge, Margaret S; Hopkins, Ramona O; Hough, Catherine L; Kress, John P; Latronico, Nicola; Moss, Marc; Needham, Dale M; Rich, Mark M; Stevens, Robert D; Wilson, Kevin C; Winkelman, Chris; Zochodne, Doug W; Ali, Naeem A

    2014-12-15

    Profound muscle weakness during and after critical illness is termed intensive care unit-acquired weakness (ICUAW). To develop diagnostic recommendations for ICUAW. A multidisciplinary expert committee generated diagnostic questions. A systematic review was performed, and recommendations were developed using the Grading, Recommendations, Assessment, Development, and Evaluation (GRADE) approach. Severe sepsis, difficult ventilator liberation, and prolonged mechanical ventilation are associated with ICUAW. Physical rehabilitation improves outcomes in heterogeneous populations of ICU patients. Because it may not be feasible to provide universal physical rehabilitation, an alternative approach is to identify patients most likely to benefit. Patients with ICUAW may be such a group. Our review identified only one case series of patients with ICUAW who received physical therapy. When compared with a case series of patients with ICUAW who did not receive structured physical therapy, evidence suggested those who receive physical rehabilitation were more frequently discharged home rather than to a rehabilitative facility, although confidence intervals included no difference. Other interventions show promise, but fewer data proving patient benefit existed, thus precluding specific comment. Additionally, prior comorbidity was insufficiently defined to determine its influence on outcome, treatment response, or patient preferences for diagnostic efforts. We recommend controlled clinical trials in patients with ICUAW that compare physical rehabilitation with usual care and further research in understanding risk and patient preferences. Research that identifies treatments that benefit patients with ICUAW is necessary to determine whether the benefits of diagnostic testing for ICUAW outweigh its burdens.

  14. Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline

    PubMed Central

    Harris, Lyndsay N.; McShane, Lisa M.; Andre, Fabrice; Collyar, Deborah E.; Gonzalez-Angulo, Ana M.; Hammond, Elizabeth H.; Kuderer, Nicole M.; Liu, Minetta C.; Mennel, Robert G.; Van Poznak, Catherine; Bast, Robert C.; Hayes, Daniel F.

    2016-01-01

    Purpose To provide recommendations on appropriate use of breast tumor biomarker assay results to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer. Methods A literature search and prospectively defined study selection sought systematic reviews, meta-analyses, randomized controlled trials, prospective-retrospective studies, and prospective comparative observational studies published from 2006 through 2014. Outcomes of interest included overall survival and disease-free or recurrence-free survival. Expert panel members used informal consensus to develop evidence-based guideline recommendations. Results The literature search identified 50 relevant studies. One randomized clinical trial and 18 prospective-retrospective studies were found to have evaluated the clinical utility, as defined by the guideline, of specific biomarkers for guiding decisions on the need for adjuvant systemic therapy. No studies that met guideline criteria for clinical utility were found to guide choice of specific treatments or regimens. Recommendations In addition to estrogen and progesterone receptors and human epidermal growth factor receptor 2, the panel found sufficient evidence of clinical utility for the biomarker assays Oncotype DX, EndoPredict, PAM50, Breast Cancer Index, and urokinase plasminogen activator and plasminogen activator inhibitor type 1 in specific subgroups of breast cancer. No biomarker except for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 was found to guide choices of specific treatment regimens. Treatment decisions should also consider disease stage, comorbidities, and patient preferences. PMID:26858339

  15. Modernizing Clinical Trial Eligibility Criteria: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research Organ Dysfunction, Prior or Concurrent Malignancy, and Comorbidities Working Group.

    PubMed

    Lichtman, Stuart M; Harvey, R Donald; Damiette Smit, Marie-Anne; Rahman, Atiqur; Thompson, Michael A; Roach, Nancy; Schenkel, Caroline; Bruinooge, Suanna S; Cortazar, Patricia; Walker, Dana; Fehrenbacher, Louis

    2017-10-02

    Purpose Patients with organ dysfunction, prior or concurrent malignancies, and comorbidities are often excluded from clinical trials. Excluding patients on the basis of these factors results in clinical trial participants who are healthier and younger than the overall population of patients with cancer. Methods ASCO and Friends of Cancer Research established a multidisciplinary working group that included experts in trial design and conduct to examine how eligibility criteria could be more inclusive. The group analyzed current eligibility criteria; conducted original data analysis; considered safety concerns, potential benefits, research, and potential hurdles of this approach through discussion; and reached consensus on recommendations regarding updated eligibility criteria that prioritize inclusiveness without compromising patient safety. Results If renal toxicity and clearance are not of direct treatment-related concern, then patients with lower creatinine clearance values of > 30 mL/min should be included in trials. Inclusion of patients with mild to moderate hepatic dysfunction may be possible when the totality of the available nonclinical and clinical data indicates that inclusion is safe. Ejection fraction values should be used with investigator assessment of a patient's risk for heart failure to determine eligibility. Patients with laboratory parameters out of normal range as a result of hematologic disease should be included in trials. Measures of patient functional status should be included in trials to better assess fit versus frail patients. Conclusion Expanding inclusion of these patients will increase the number and diversity of patients in clinical trials and result in a more appropriate population of patients.

  16. The Spanish Society of Neurology's official clinical practice guidelines for epilepsy. Special considerations in epilepsy: comorbidities, women of childbearing age, and elderly patients.

    PubMed

    Mauri Llerda, J A; Suller Marti, A; de la Peña Mayor, P; Martínez Ferri, M; Poza Aldea, J J; Gomez Alonso, J; Mercadé Cerdá, J M

    2015-10-01

    The characteristics of some population groups (patients with comorbidities, women of childbearing age, the elderly) may limit epilepsy management. Antiepileptic treatment in these patients may require adjustments. We searched articles in Pubmed, clinical practice guidelines for epilepsy, and recommendations by the most relevant medical societies regarding epilepsy in special situations (patients with comorbidities, women of childbearing age, the elderly). Evidence and recommendations are classified according to the prognostic criteria of Oxford Centre of Evidence-Based Medicine (2001) and the European Federation of Neurological Societies (2004) for therapeutic interventions. Epilepsy treatment in special cases of comorbidities must be selected properly to improve efficacy with the fewest side effects. Adjusting antiepileptic medication and/or hormone therapy is necessary for proper seizure management in catamenial epilepsy. Exposure to antiepileptic drugs (AED) during pregnancy increases the risk of birth defects and may affect fetal growth and/or cognitive development. Postpartum breastfeeding is recommended, with monitoring for adverse effects if sedative AEDs are used. Finally, the elderly are prone to epilepsy, and diagnostic and treatment characteristics in this group differ from those of other age groups. Although therapeutic limitations may be more frequent in older patients due to comorbidities, they usually respond better to lower doses of AEDs than do other age groups. Copyright © 2014 Sociedad Española de Neurología. Published by Elsevier España, S.L.U. All rights reserved.

  17. Use of Biomarkers to Guide Decisions on Systemic Therapy for Women With Metastatic Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline

    PubMed Central

    Van Poznak, Catherine; Somerfield, Mark R.; Bast, Robert C.; Cristofanilli, Massimo; Goetz, Matthew P.; Gonzalez-Angulo, Ana M.; Hicks, David G.; Hill, Elizabeth G.; Liu, Minetta C.; Lucas, Wanda; Mayer, Ingrid A.; Mennel, Robert G.; Symmans, William F.; Hayes, Daniel F.; Harris, Lyndsay N.

    2015-01-01

    Purpose To provide recommendations on the appropriate use of breast tumor biomarker assay results to guide decisions on systemic therapy for metastatic breast cancer. Methods A literature search and prospectively defined study selection identified systematic reviews, meta-analyses, randomized controlled trials (RCTs), prospective–retrospective studies, and prospective comparative observational studies published from 2006 through September 2014. Results The literature search revealed 17 articles that met criteria for further review: 11 studies reporting discordances between primary tumors and metastases in expression of hormone receptors or human epidermal growth factor receptor 2 (HER2), one RCT that addressed the use of a biomarker to decide whether to change or continue a treatment regimen, and five prospective–retrospective studies that evaluated the clinical utility of biomarkers. Recommendations In patients with accessible metastases, biopsy for confirmation of disease process and retesting of estrogen receptor, progesterone receptor, and HER2 status should be offered, but evidence is lacking to determine whether changing anticancer treatment on the basis of change in receptor status affects clinical outcomes. With discordance of results between primary and metastatic tissues, the Panel consensus is to use preferentially the estrogen receptor, progesterone receptor, and HER2 status of the metastasis to direct therapy if supported by the clinical scenario and patient's goals for care. Carcinoembryonic antigen, cancer antigen 15-3, and cancer antigen 27-29 may be used as adjunctive assessments, but not alone, to contribute to decisions regarding therapy. Recommendations for tumor rebiopsy and use of circulating tumor markers are based on clinical experience and Panel informal consensus in the absence of studies designed to evaluate the clinical utility of the markers. As such, it is also reasonable for clinicians to not use these markers as adjunctive

  18. [Clinical practice guidelines of the Team of Experts of the Polish Gynecological Society: management of the intrahepatic cholestasis of pregnancy].

    PubMed

    Leszczyńska-Gorzelak, Bozena; Oleszczuk, Jan; Marciniak, Beata; Poreba, Ryszard; Oszukowski, Przemysław; Wielgoś, Mirosław; Czajkowski, Krzysztof

    2012-09-01

    Intrahepatic Cholestasis of Pregnancy (ICP) constitutes the most common, reversible liver disease closely connected with pregnancy and spontaneously resolving in puerperium. ICP usually reoccurs in consecutive pregnancies (45-90%), often in a more intensified form. Many compounds (hormones, cytokines, medicines, endotoxins) can impair transport in the hepatocyte, disturb the intracellular transport and increase the permeability of the intercellular connections. As a result, the elements of bile may appear in the peripheral blood. Gestational cholestasis constitutes a classic example of intrahepatic cholestasis. The etiology of ICP is multifactorial with hormonal, genetic and environmental factors participating in the process. The diagnosis is based on the presence of pruritus, elevated values of bile acids in the blood serum and of aminotransferases (aspartic, aminopropionic and gamma-glutamylotranspeptydase (AspAt, AlAt, GGTP)), as well as spontaneous remission in the second or third week after childbirth, of lack of other illnesses causing pruritus and icterus. Clinical and biochemical symptoms of ICP include: pruritus without skin rash (usually after 30 weeks of gestation), mild icterus, steatorrhea etc. Abnormalities in the laboratory tests of the LFT (liver function tests) encompass: an increase in the serum concentration of fatty acids (BA) which can be the first and only laboratory abnormality. Concentrations surpassing 10 micromol/l are considered to be abnormal. Concentration of BA higher than 40 micromol/l allows to recognize a case of severe ICP, connected with the risk of premature delivery presence of the meconium liquor, surgical means of delivery and low APGAR score of the newborn (< 7 pt). In about 80% of pregnant women with ICP, the BA concentration ranges between 10-40 micromol/l, but perinatal results are comparable with uncomplicated pregnancies. Some authors are of the opinion that abnormal AlAt value is the most sensitive test, other authors

  19. Primary prevention of cardiovascular disease and type 2 diabetes in patients at metabolic risk: an endocrine society clinical practice guideline.

    PubMed

    Rosenzweig, James L; Ferrannini, Ele; Grundy, Scott M; Haffner, Steven M; Heine, Robert J; Horton, Edward S; Kawamori, Ryuzo

    2008-10-01

    The objective was to develop clinical practice guidelines for the primary prevention of cardiovascular disease (CVD) and type 2 diabetes mellitus (T2DM) in patients at metabolic risk. Healthcare providers should incorporate into their practice concrete measures to reduce the risk of developing CVD and T2DM. These include the regular screening and identification of patients at metabolic risk (at higher risk for both CVD and T2DM) with measurement of blood pressure, waist circumference, fasting lipid profile, and fasting glucose. All patients identified as having metabolic risk should undergo 10-yr global risk assessment for either CVD or coronary heart disease. This scoring will determine the targets of therapy for reduction of apolipoprotein B-containing lipoproteins. Careful attention should be given to the treatment of elevated blood pressure to the targets outlined in this guideline. The prothrombotic state associated with metabolic risk should be treated with lifestyle modification measures and in appropriate individuals with low-dose aspirin prophylaxis. Patients with prediabetes (impaired glucose tolerance or impaired fasting glucose) should be screened at 1- to 2-yr intervals for the development of diabetes with either measurement of fasting plasma glucose or a 2-h oral glucose tolerance test. For the prevention of CVD and T2DM, we recommend that priority be given to lifestyle management. This includes antiatherogenic dietary modification, a program of increased physical activity, and weight reduction. Efforts to promote lifestyle modification should be considered an important component of the medical management of patients to reduce the risk of both CVD and T2DM.

  20. Brachytherapy for Patients With Prostate Cancer: American Society of Clinical Oncology/Cancer Care Ontario Joint Guideline Update.

    PubMed

    Chin, Joseph; Rumble, R Bryan; Kollmeier, Marisa; Heath, Elisabeth; Efstathiou, Jason; Dorff, Tanya; Berman, Barry; Feifer, Andrew; Jacques, Arthur; Loblaw, D Andrew

    2017-03-27

    Purpose To jointly update the Cancer Care Ontario guideline on brachytherapy for patients with prostate cancer to account for new evidence. Methods An Update Panel conducted a targeted systematic literature review and identified more recent randomized controlled trials comparing dose-escalated external beam radiation therapy (EBRT) with brachytherapy in men with prostate cancer. Results Five randomized controlled trials provided the evidence for this update. Recommendations For patients with low-risk prostate cancer who require or choose active treatment, low-dose rate brachytherapy (LDR) alone, EBRT alone, and/or radical prostatectomy (RP) should be offered to eligible patients. For patients with intermediate-risk prostate cancer choosing EBRT with or without androgen-deprivation therapy, brachytherapy boost (LDR or high-dose rate [HDR]) should be offered to eligible patients. For low-intermediate risk prostate cancer (Gleason 7, prostate-specific antigen < 10 ng/mL or Gleason 6, prostate-specific antigen, 10 to 20 ng/mL), LDR brachytherapy alone may be offered as monotherapy. For patients with high-risk prostate cancer receiving EBRT and androgen-deprivation therapy, brachytherapy boost (LDR or HDR) should be offered to eligible patients. Iodine-125 and palladium-103 are each reasonable isotope options for patients receiving LDR brachytherapy; no recommendation can be made for or against using cesium-131 or HDR monotherapy. Patients should be encouraged to participate in clinical trials to test novel or targeted approaches to this disease. Additional information is available at www.asco.org/Brachytherapy-guideline and www.asco.org/guidelineswiki .

  1. Natural history and clinical outcome of "uncorrected" scimitar syndrome patients: a multicenter study of the italian society of pediatric cardiology.

    PubMed

    Vida, Vladimiro L; Padrini, Maddalena; Boccuzzo, Giovanna; Agnoletti, Gabriella; Bondanza, Sara; Butera, Gianfranco; Chiappa, Enrico; Marasini, Maurizio; Pilati, Mara; Pongiglione, Giacomo; Prandstraller, Daniela; Russo, Maria Giovanna; Castaldi, Biagio; Santoro, Giuseppe; Spadoni, Isabella; Stellin, Giovanni; Milanesi, Ornella

    2013-07-01

    To analyze the clinical status of patients with "uncorrected" scimitar syndrome in a multicenter Italian study. The natural history of scimitar syndrome was analyzed in 44 affected individuals (from 9 Italian centers). The median age at diagnosis was 1.05 years (range, 1 day-41 years). Thirty-three patients (75%) had an isolated form; 11 patients (25%) had associated congenital heart diseases. Twenty-two patients (50%) were symptomatic at diagnosis, including respiratory symptoms (n=20) and congestive heart failure (n=6). Patients with associated congenital heart defects had a higher prevalence of congestive heart failure (4 of 11 [36.4%] vs 2 of 33 [6.1%]; P=.027), pulmonary arterial hypertension (7 of 11 [63.6%] vs 2 of 33 [6.1%]; P=.027) than patients with isolated forms. Ten patients (22.7%) underwent correction of associated cardiac defects, leaving the anomalous pulmonary venous drainage intact. The median length of follow-up after diagnosis was 6.4 years (range, 0.2-27.5 years). Two patients died, both with associated cardiac defects and severe pulmonary arterial hypertension. Of 42 survivors, 39 (92.8%) were asymptomatic at the last follow-up visit; 3 patients still complained respiratory symptoms. There was no difference between isolated and associated forms of the disease. In most patients, scimitar syndrome presented as an isolated lesion with a benign outcome. Nonetheless, when associated with other cardiac defects and pulmonary arterial hypertension, there was an increased risk of congestive heart failure and mortality. Correction of associated cardiac defects (transforming "associated" into "isolated" forms), together with the therapeutic occlusion of anomalous arterial supply to the lung, led to a benign outcome comparable to that in primarily isolated forms. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  2. An official American Thoracic Society clinical practice guideline: diagnosis, risk stratification, and management of pulmonary hypertension of sickle cell disease.

    PubMed

    Klings, Elizabeth S; Machado, Roberto F; Barst, Robyn J; Morris, Claudia R; Mubarak, Kamal K; Gordeuk, Victor R; Kato, Gregory J; Ataga, Kenneth I; Gibbs, J Simon; Castro, Oswaldo; Rosenzweig, Erika B; Sood, Namita; Hsu, Lewis; Wilson, Kevin C; Telen, Marilyn J; Decastro, Laura M; Krishnamurti, Lakshmanan; Steinberg, Martin H; Badesch, David B; Gladwin, Mark T

    2014-03-15

    In adults with sickle cell disease (SCD), an increased tricuspid regurgitant velocity (TRV) measured by Doppler echocardiography, an increased serum N-terminal pro-brain natriuretic peptide (NT-pro-BNP) level, and pulmonary hypertension (PH) diagnosed by right heart catheterization (RHC) are independent risk factors for mortality. A multidisciplinary committee was formed by clinician-investigators experienced in the management of patients with PH and/or SCD. Clinically important questions were posed, related evidence was appraised, and questions were answered with evidence-based recommendations. Target audiences include all clinicians who take care of patients with SCD. Mortality risk stratification guides decision making. An increased risk for mortality is defined as a TRV equal to or greater than 2.5 m/second, an NT-pro-BNP level equal to or greater than 160 pg/ml, or RHC-confirmed PH. For patients identified as having increased mortality risk, we make a strong recommendation for hydroxyurea as first-line therapy and a weak recommendation for chronic transfusions as an alternative therapy. For all patients with SCD with elevated TRV alone or elevated NT-pro-BNP alone, and for patients with SCD with RHC-confirmed PH with elevated pulmonary artery wedge pressure and low pulmonary vascular resistance, we make a strong recommendation against PAH-specific therapy. However, for select patients with SCD with RHC-confirmed PH who have elevated pulmonary vascular resistance and normal pulmonary capillary wedge pressure, we make a weak recommendation for either prostacyclin agonist or endothelin receptor antagonist therapy and a strong recommendation against phosphodiesterase-5 inhibitor therapy. Evidence-based recommendations for the management of patients with SCD with increased mortality risk are provided, but will require frequent reassessment and updating.

  3. An Official American Thoracic Society Clinical Practice Guideline: Diagnosis, Risk Stratification, and Management of Pulmonary Hypertension of Sickle Cell Disease

    PubMed Central

    Klings, Elizabeth S.; Machado, Roberto F.; Barst, Robyn J.; Morris, Claudia R.; Mubarak, Kamal K.; Gordeuk, Victor R.; Kato, Gregory J.; Ataga, Kenneth I.; Gibbs, J. Simon; Castro, Oswaldo; Rosenzweig, Erika B.; Sood, Namita; Hsu, Lewis; Wilson, Kevin C.; Telen, Marilyn J.; DeCastro, Laura M.; Krishnamurti, Lakshmanan; Steinberg, Martin H.; Badesch, David B.; Gladwin, Mark T.

    2014-01-01

    Background: In adults with sickle cell disease (SCD), an increased tricuspid regurgitant velocity (TRV) measured by Doppler echocardiography, an increased serum N-terminal pro–brain natriuretic peptide (NT-pro-BNP) level, and pulmonary hypertension (PH) diagnosed by right heart catheterization (RHC) are independent risk factors for mortality. Methods: A multidisciplinary committee was formed by clinician-investigators experienced in the management of patients with PH and/or SCD. Clinically important questions were posed, related evidence was appraised, and questions were answered with evidence-based recommendations. Target audiences include all clinicians who take care of patients with SCD. Results: Mortality risk stratification guides decision making. An increased risk for mortality is defined as a TRV equal to or greater than 2.5 m/second, an NT-pro-BNP level equal to or greater than 160 pg/ml, or RHC-confirmed PH. For patients identified as having increased mortality risk, we make a strong recommendation for hydroxyurea as first-line therapy and a weak recommendation for chronic transfusions as an alternative therapy. For all patients with SCD with elevated TRV alone or elevated NT-pro-BNP alone, and for patients with SCD with RHC-confirmed PH with elevated pulmonary artery wedge pressure and low pulmonary vascular resistance, we make a strong recommendation against PAH-specific therapy. However, for select patients with SCD with RHC-confirmed PH who have elevated pulmonary vascular resistance and normal pulmonary capillary wedge pressure, we make a weak recommendation for either prostacyclin agonist or endothelin receptor antagonist therapy and a strong recommendation against phosphodiesterase-5 inhibitor therapy. Conclusions: Evidence-based recommendations for the management of patients with SCD with increased mortality risk are provided, but will require frequent reassessment and updating. PMID:24628312

  4. Neurophysiological localisation of ulnar neuropathy at the elbow: Validation of diagnostic criteria developed by a taskforce of the Danish Society of clinical neurophysiology.

    PubMed

    Pugdahl, K; Beniczky, S; Wanscher, B; Johnsen, B; Qerama, E; Ballegaard, M; Benedek, K; Juhl, A; Ööpik, M; Selmar, P; Sønderborg, J; Terney, D; Fuglsang-Frederiksen, A

    2017-09-09

    This study validates consensus criteria for localisation of ulnar neuropathy at elbow (UNE) developed by a taskforce of the Danish Society of Clinical Neurophysiology and compares them to the existing criteria from the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM). The Danish criteria are based on combinations of conduction slowing in the segments of the elbow and forearm expressed in Z-scores, and difference between the segments in m/s. Examining fibres to several muscles and sensory fibres can increase the certainty of the localisation. Diagnostic accuracy for UNE was evaluated on 181 neurophysiological studies of the ulnar nerve from 171 peer-reviewed patients from a mixed patient-group. The diagnostic reference standard was the consensus diagnosis based on all available clinical, laboratory, and electrodiagnostic information reached by a group of experienced Danish neurophysiologists. The Danish criteria had high specificity (98.4%) and positive predictive value (PPV) (95.2%) and fair sensitivity (76.9%). Compared to the AANEM criteria, the Danish criteria had higher specificity (p<0.001) and lower sensitivity (p=0.02). The Danish consensus criteria for UNE are very specific and have high PPV. The Danish criteria for UNE are reliable and well suited for use in different centres as they are based on Z-scores. Copyright © 2017 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.

  5. Comparison between cancer specialists and general physicians regarding the education of nurse practitioners in Japan: a postal survey of the Japanese Society of Clinical Oncology.

    PubMed

    Ishida, Yasushi; Hatao, Masahiko; Fukushima, Osamu; Mori, Michiko; Isozaki, Fumiko; Okuyama, Asako

    2013-10-01

    Japanese physicians' attitudes regarding the education of nurse practitioners (NPs) are not well described. A survey was mailed to 1,094 board members of the Japanese Society of Clinical Oncology (JSCO) and the Japanese Primary Care Association (JPCA), and the directors of the clinical training program for physicians. The physicians of JSCO were classified as the cancer specialist group, and both the board members of JPCA and the directors of the clinical training program for physicians constituted the general physician group. We compared the responses of cancer specialists and general physicians. The survey response rate was 25.9% (69 of 266) in the cancer specialist group and 19.4% (161 of 828) in the general physician group. The median age of respondents was 53 and 55 years, respectively, of which 84 and 79%, respectively, were men. We found that the percentages of respondents who considered NP education necessary were almost identical in the 2 groups (r = 0.898, p < 0.0001). Education items considered necessary for NPs by >80% respondents in both groups included many symptoms, emergency management, basic procedures, general screening, palliative care including management against adverse effects, health education, and communication. More cancer specialists than general physicians (p < 0.01) expected NPs to be educated in multidisciplinary practice and palliative care, including management against adverse effects. Our study suggests that cancer specialists expect NPs to provide symptom management and psychosocial support, clarify information, provide education, and work as a member of a multidisciplinary team.

  6. Time, Clinic Technologies, and the Making of Reflexive Longevity: The cultural work of ‘time left’ in an aging society

    PubMed Central

    Kaufman, Sharon R.

    2010-01-01

    Developments in clinical intervention are having a profound impact on health and health behaviors in late life and on ideas about longevity and the appropriate time for death. The fact that the timing of death is even considered to be a controllable event is a relatively new cultural phenomenon. The activities that make up life extension, like other medical practices scrutinized by social scientists, constitute a site for the emergence of new forms of subjectivity. For older adults the clinical encounter forces a calculation about how much ‘time left’ is wanted in relation to age. The twin dimensions of the transformation of time highlighted in this essay -- the control over the timing of death and the creation of ‘time left’ -- both contribute to and are a widespread effect of biomedicalization in affluent sectors of society. Through three stories this essay begins to map the cultural work that the concept, ‘time left,’ does, the socio-medical ways in which that notion is talked about, organized and calculated in the American clinic today. It asks, what kind of subject emerges when longevity, imbued with the technological, becomes a reflexive practice and an object of intervention and apparent choice? PMID:20422745

  7. Barriers to a Career Focus in Cancer Prevention: A Report and Initial Recommendations From the American Society of Clinical Oncology Cancer Prevention Workforce Pipeline Work Group

    PubMed Central

    Meyskens, Frank L.; Bajorin, Dean F.; George, Thomas J.; Jeter, Joanne M.; Khan, Shakila; Tyne, Courtney A.; William, William N.

    2016-01-01

    Purpose To assist in determining barriers to an oncology career incorporating cancer prevention, the American Society of Clinical Oncology (ASCO) Cancer Prevention Workforce Pipeline Work Group sponsored surveys of training program directors and oncology fellows. Methods Separate surveys with parallel questions were administered to training program directors at their fall 2013 retreat and to oncology fellows as part of their February 2014 in-training examination survey. Forty-seven (67%) of 70 training directors and 1,306 (80%) of 1,634 oncology fellows taking the in-training examination survey answered questions. Results Training directors estimated that ≤ 10% of fellows starting an academic career or entering private practice would have a career focus in cancer prevention. Only 15% of fellows indicated they would likely be interested in cancer prevention as a career focus, although only 12% thought prevention was unimportant relative to treatment. Top fellow-listed barriers to an academic career were difficulty in obtaining funding and lower compensation. Additional barriers to an academic career with a prevention focus included unclear career model, lack of clinical mentors, lack of clinical training opportunities, and concerns about reimbursement. Conclusion Reluctance to incorporate cancer prevention into an oncology career seems to stem from lack of mentors and exposure during training, unclear career path, and uncertainty regarding reimbursement. Suggested approaches to begin to remedy this problem include: 1) more ASCO-led and other prevention educational resources for fellows, training directors, and practicing oncologists; 2) an increase in funded training and clinical research opportunities, including reintroduction of the R25T award; 3) an increase in the prevention content of accrediting examinations for clinical oncologists; and 4) interaction with policymakers to broaden the scope and depth of reimbursement for prevention counseling and

  8. [Present situation and future prospects of the certification system for medical technologists--from the viewpoint of the Japanese Society of Clinical Cytology].

    PubMed

    Hatakeyama, Shigeharu; Hirooka, Yasuaki

    2012-06-01

    The circumstances surrounding the certification examination for cytotechnologists in Japan are closely related with the history of the Japanese Society of Clinical Cytology. The examination for cytotechnologists is open only to medical technologists. The examination has two parts: primary and secondary. Qualification for candidacy for the secondary examination requires candidates to have passed the primary examination. The rate of successful applicants in the past 10 years was approximately 25-40%. Certified cytotechnologists are required to renew their qualifications every 4 years for their study and job history. I will present the purpose of the qualification update system, future themes, the reporting system for cytodiagnosis, and the possibility that the certification examination for cytotechnologists will become a national examination.

  9. Controversial issues in CKD clinical practice: position statement of the CKD-treatment working group of the Italian Society of Nephrology.

    PubMed

    Bellizzi, Vincenzo; Conte, Giuseppe; Borrelli, Silvio; Cupisti, Adamasco; De Nicola, Luca; Di Iorio, Biagio R; Cabiddu, Gianfranca; Mandreoli, Marcora; Paoletti, Ernesto; Piccoli, Giorgina B; Quintaliani, Giuseppe; Ravera, Maura; Santoro, Domenico; Torraca, Serena; Minutolo, Roberto

    2017-04-01

    This position paper of the study group "Conservative treatment of Chronic Kidney Disease-CKD" of the Italian Society of Nephrology addresses major practical, unresolved, issues related to the conservative treatment of chronic renal disease. Specifically, controversial topics from everyday clinical nephrology practice which cannot find a clear, definitive answer in the current literature or in nephrology guidelines are discussed. The paper reports the point of view of the study group. Concise and practical advice is given on several common issues: renal biopsy in diabetes; dual blockade of the renin-angiotensin-aldosterone system (RAAS); management of iron deficiency; low protein diet; dietary salt intake; bicarbonate supplementation; treatment of obesity; the choice of conservative therapy vs. dialysis. For each topic synthetic statements, guideline-style, are reported.

  10. [Best practices for the safe use of parenteral nutrition multi-chamber bags. Spanish Society of Hospital Pharmacist's Clinical Nutrition Group].

    PubMed

    Sirvent, M; Calvo, M V; Pérez-Pons, J C; Rodríguez-Penín, I; Marti-Bonmatí, E; Vázquez, A; Romero, R; Crespo, C L; Tejada, P

    2014-09-16

    Patient security is one of the key aspects of the Health-System. Parenteral Nutrition is included in the ISMP's list of high-alert medication, being its appropiate use an essential element in maximizing effectiviness while minimizing the potential risk of errors associated with its use. Multi-chamber bags offer several advantages versus pharmacy bespoke bags. However, their apparent simplicity may induce to misuse, asuming their use requires limited consideration, thus increasing the risk of potential errors. For this reason, the Spanish Society of Hospital Pharmacist's Clinical Nutrition Group considered it essential to develop a list of safety practices regarding the use of parenteral nutrition multi-chamber bags. These recommendations are based on practices globally accepted to diminish errors in PN therapy. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

  11. Almanac 2011: acute coronary syndromes. The national society journals present selected research that has driven recent advances in clinical cardiology.

    PubMed

    Knight, Charles J; Timmis, Adam D

    2011-12-01

    This overview highlights some recent advances in the epidemiology, diagnosis, risk stratification and treatment of acute coronary syndromes. The sheer volume of new studies reflects the robust state of global cardiovascular research but the focus here is on findings that are of most interest to the practising cardiologist. Incidence and mortality rates for myocardial infarction are in decline, probably owing to a combination of lifestyle changes, particularly smoking cessation, and improved pharmacological and interventional treatment. Troponins remain central for diagnosis and new high-sensitivity assays are further lowering detection thresholds and improving outcomes. The incremental diagnostic value of other circulating biomarkers remains unclear and for risk stratification simple clinical algorithms such as the GRACE score have proved more useful. Primary PCI with minimal treatment delay is the most effective reperfusion strategy in ST elevation myocardial infarction (STEMI). Radial access is associated with less bleeding than with the femoral approach, but outcomes appear similar. Manual thrombectomy limits distal embolisation and infarct size while drug-eluting stents reduce the need for further revascularisation procedures. Non-culprit disease is best dealt with electively as a staged procedure after primary PCI has been completed. The development of antithrombotic and antiplatelet regimens for primary PCI continues to evolve, with new indications for fondaparinux and bivalirudin as well as small-molecule glycoprotein (GP)IIb/IIIa inhibitors. If timely primary PCI is unavailable, fibrinolytic treatment remains an option but a strategy of early angiographic assessment is recommended for all patients. Non-ST segment elevation myocardial infarction(NSTEMI) is now the dominant phenotype and out-comes after the acute phase are significantly worse than for STEMI. Many patients with NSTEMI remain undertreated and there is a large body of recent work seeking to

  12. Electronic nicotine delivery systems: a policy statement from the American Association for Cancer Research and the American Society of Clinical Oncology.

    PubMed

    Brandon, Thomas H; Goniewicz, Maciej L; Hanna, Nasser H; Hatsukami, Dorothy K; Herbst, Roy S; Hobin, Jennifer A; Ostroff, Jamie S; Shields, Peter G; Toll, Benjamin A; Tyne, Courtney A; Viswanath, Kasisomayajula; Warren, Graham W

    2015-02-01

    Combustible tobacco use remains the number one preventable cause of disease, disability, and death in the United States. Electronic nicotine delivery systems (ENDS), which include e-cigarettes, are devices capable of delivering nicotine in an aerosolized form. ENDS use by both adults and youth has increased rapidly, and some have advocated these products could serve as harm-reduction devices and smoking cessation aids. ENDS may be beneficial if they reduce smoking rates or prevent or reduce the known adverse health effects of smoking. However, ENDS may also be harmful, particularly to youth, if they increase the likelihood that nonsmokers or formers smokers will use combustible tobacco products or if they discourage smokers from quitting. The American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO) recognize the potential ENDS have to alter patterns of tobacco use and affect the public's health; however, definitive data are lacking. AACR and ASCO recommend additional research on these devices, including assessing the health impacts of ENDS, understanding patterns of ENDS use, and determining what role ENDS have in cessation. Key policy recommendations include supporting federal, state, and local regulation of ENDS; requiring manufacturers to register with the FDA and report all product ingredients, requiring childproof caps on ENDS liquids, and including warning labels on products and their advertisements; prohibiting youth-oriented marketing and sales; prohibiting child-friendly ENDS flavors; and prohibiting ENDS use in places where cigarette smoking is prohibited. ©2015 American Association for Cancer Research and American Society of Clinical Oncology.

  13. Modernizing Clinical Trial Eligibility Criteria: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research Brain Metastases Working Group.

    PubMed

    Lin, Nancy U; Prowell, Tatiana; Tan, Antoinette R; Kozak, Marina; Rosen, Oliver; Amiri-Kordestani, Laleh; White, Julia; Sul, Joohee; Perkins, Louise; Beal, Katherine; Gaynor, Richard; Kim, Edward S

    2017-10-02

    Purpose Broadening trial eligibility to improve accrual and access and to better reflect intended-to-treat populations has been recognized as a priority. Historically, patients with brain metastases have been understudied, because of restrictive eligibility across all phases of clinical trials. Methods In 2016, after a literature search and series of teleconferences, a multistakeholder workshop was convened. Our working group focused on developing consensus recommendations regarding the inclusion of patients with brain metastases in clinical trials, as part of a broader effort that encompassed minimum age, HIV status, and organ dysfunction. The working group attempted to balance the needs of protecting patient safety, facilitating access to investigational therapies, and ensuring trial integrity. On the basis of input at the workshop, guidelines were further refined and finalized. Results The working group identified three key populations: those with treated/stable brain metastases, defined as patients who have received prior therapy for their brain metastases and whose CNS disease is radiographically stable at study entry; those with active brain metastases, defined as new and/or progressive brain metastases at the time of study entry; and those with leptomeningeal disease. In most circumstances, the working group encourages the inclusion of patients with treated/stable brain metastases in clinical trials. A framework of key considerations for patients with active brain metastases was developed. For patients with leptomeningeal disease, inclusion of a separate cohort in both early-phase and later-phase trials is recommended, if CNS activity is anticipated and when relevant to the specific disease type. Conclusion Expanding eligibility to be more inclusive of patients with brain metastasis is justified in many cases and may speed the development of effective therapies in this area of high clinical need.

  14. Extended RAS Gene Mutation Testing in Metastatic Colorectal Carcinoma to Predict Response to Anti-Epidermal Growth Factor Receptor Monoclonal Antibody Therapy: American Society of Clinical Oncology Provisional Clinical Opinion Update 2015.

    PubMed

    Allegra, Carmen J; Rumble, R Bryan; Hamilton, Stanley R; Mangu, Pamela B; Roach, Nancy; Hantel, Alexander; Schilsky, Richard L

    2016-01-10

    An American Society of Clinical Oncology Provisional Clinical Opinion (PCO) offers timely clinical direction after publication or presentation of potentially practice-changing data from major studies. This PCO update addresses the utility of extended RAS gene mutation testing in patients with metastatic colorectal cancer (mCRC) to detect resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibody (MoAb) therapy. Recent results from phase II and III clinical trials in mCRC demonstrate that patients whose tumors harbor RAS mutations in exons 2 (codons 12 and 13), 3 (codons 59 and 61), and 4 (codons 117 and 146) are unlikely to benefit from therapy with MoAbs directed against EGFR, when used as monotherapy or combined with chemotherapy. In addition to the evidence reviewed in the original PCO, 11 systematic reviews with meta-analyses, two retrospective analyses, and two health technology assessments based on a systematic review were obtained. These evaluated the outcomes for patients with mCRC with no mutation detected or presence of mutation in additional exons in KRAS and NRAS. PCO: All patients with mCRC who are candidates for anti-EGFR antibody therapy should have their tumor tested in a Clinical Laboratory Improvement Amendments-certified laboratory for mutations in both KRAS and NRAS exons 2 (codons 12 and 13), 3 (codons 59 and 61), and 4 (codons 117 and 146). The weight of current evidence indicates that anti-EGFR MoAb therapy should only be considered for treatment of patients whose tumor is determined to not have mutations detected after such extended RAS testing. © 2015 by American Society of Clinical Oncology.

  15. A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS).

    PubMed

    Cherny, N I; Sullivan, R; Dafni, U; Kerst, J M; Sobrero, A; Zielinski, C; de Vries, E G E; Piccart, M J

    2015-08-01

    The value of any new therapeutic strategy or treatment is determined by the magnitude of its clinical benefit balanced against its cost. Evidence for clinical benefit from new treatment options is derived from clinical research, in particular phase III randomised trials, which generate unbiased data regarding the efficacy, benefit and safety of new therapeutic approaches. To date, there is no standard tool for grading the magnitude of clinical benefit of cancer therapies, which may range from trivial (median progression-free survival advantage of only a few weeks) to substantial (improved long-term survival). Indeed, in the absence of a standardised approach for grading the magnitude of clinical benefit, conclusions and recommendations derived from studies are often hotly disputed and very modest incremental advances have often been presented, discussed and promoted as major advances or 'breakthroughs'. Recognising the importance of presenting clear and unbiased statements regarding the magnitude of the clinical benefit from new therapeutic approaches derived from high-quality clinical trials, the European Society for Medical Oncology (ESMO) has developed a validated and reproducible tool to assess the magnitude of clinical benefit for cancer medicines, the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS). This tool uses a rational, structured and consistent approach to derive a relative ranking of the magnitude of clinically meaningful benefit that can be expected from a new anti-cancer treatment. The ESMO-MCBS is an important first step to the critical public policy issue of value in cancer care, helping to frame the appropriate use of limited public and personal resources to deliver cost-effective and affordable cancer care. The ESMO-MCBS will be a dynamic tool and its criteria will be revised on a regular basis.

  16. Abridged version of the AWMF guideline for the medical clinical diagnostics of indoor mould exposure: S2K Guideline of the German Society of Hygiene, Environmental Medicine and Preventive Medicine (GHUP) in collaboration with the German Association of Allergists (AeDA), the German Society of Dermatology (DDG), the German Society for Allergology and Clinical Immunology (DGAKI), the German Society for Occupational and Environmental Medicine (DGAUM), the German Society for Hospital Hygiene (DGKH), the German Society for Pneumology and Respiratory Medicine (DGP), the German Mycological Society (DMykG), the Society for Pediatric Allergology and Environmental Medicine (GPA), the German Federal Association of Pediatric Pneumology (BAPP), and the Austrian Society for Medical Mycology (ÖGMM).

    PubMed

    Wiesmüller, Gerhard A; Heinzow, Birger; Aurbach, Ute; Bergmann, Karl-Christian; Bufe, Albrecht; Buzina, Walter; Cornely, Oliver A; Engelhart, Steffen; Fischer, Guido; Gabrio, Thomas; Heinz, Werner; Herr, Caroline E W; Kleine-Tebbe, Jörg; Klimek, Ludger; Köberle, Martin; Lichtnecker, Herbert; Lob-Corzilius, Thomas; Merget, Rolf; Mülleneisen, Norbert; Nowak, Dennis; Rabe, Uta; Raulf, Monika; Seidl, Hans Peter; Steiß, Jens-Oliver; Szewszyk, Regine; Thomas, Peter; Valtanen, Kerttu; Hurraß, Julia

    2017-01-01

    This article is an abridged version of the AWMF mould guideline "Medical clinical diagnostics of indoor mould exposure" presented in April 2016 by the German Society of Hygiene, Environmental Medicine and Preventive Medicine (Gesellschaft für Hygiene, Umweltmedizin und Präventivmedizin, GHUP), in collaboration with the above-mentioned scientific medical societies, German and Austrian societies, medical associations and experts. Indoor mould growth is a potential health risk, even if a quantitative and/or causal relationship between the occurrence of individual mould species and health problems has yet to be established. Apart from allergic bronchopulmonary aspergillosis (ABPA) and mould-caused mycoses, only sufficient evidence for an association between moisture/mould damage and the following health effects has been established: allergic respiratory disease, asthma (manifestation, progression and exacerbation), allergic rhinitis, hypersensitivity pneumonitis (extrinsic allergic alveolitis), and increased likelihood of respiratory infections/bronchitis. In this context the sensitizing potential of moulds is obviously low compared to other environmental allergens. Recent studies show a comparatively low sensitizing prevalence of 3-10% in the general population across Europe. Limited or suspected evidence for an association exist with respect to mucous membrane irritation and atopic eczema (manifestation, progression and exacerbation). Inadequate or insufficient evidence for an association exist for chronic obstructive pulmonary disease, acute idiopathic pulmonary hemorrhage in children, rheumatism/arthritis, sarcoidosis and cancer. The risk of infection posed by moulds regularly occurring indoors is low for healthy persons; most species are in risk group 1 and a few in risk group 2 (Aspergillus fumigatus, A. flavus) of the German Biological Agents Act (Biostoffverordnung). Only moulds that are potentially able to form toxins can be triggers of toxic reactions

  17. Cryptozoology Society

    NASA Astrophysics Data System (ADS)

    Richman, Barbara T.

    Reports of Loch Ness monsters, Bigfoot, and the Yeti spring u p from time to time, sparking scientific controversy about the veracity of these observations. Now an organization has been established to help cull, analyze, and disseminate information on the alleged creatures. The International Society of Cryptozoology, formed at a January meeting at the U.S. National Museum of Natural History of the Smithsonian Institution, will serve as the focal point for the investigation, analysis, publication, and discussion of animals of unexpected form or size or of unexpected occurrences in time or space.

  18. Second-Line Hormonal Therapy for Men With Chemotherapy-Naïve, Castration-Resistant Prostate Cancer: American Society of Clinical Oncology Provisional Clinical Opinion.

    PubMed

    Virgo, Katherine S; Basch, Ethan; Loblaw, D Andrew; Oliver, Thomas K; Rumble, R Bryan; Carducci, Michael A; Nordquist, Luke; Taplin, Mary-Ellen; Winquist, Eric; Singer, Eric A

    2017-06-10

    Purpose ASCO provisional clinical opinions (PCOs) offer direction to the ASCO membership after publication or presentation of potential practice-changing data. This PCO addresses second-line hormonal therapy for chemotherapy-naïve men with castration-resistant prostate cancer (CRPC) who range from being asymptomatic with only biochemical evidence of CRPC to having documented metastases but minimal symptoms. Clinical Context The treatment goal for CRPC is palliation. Despite resistance to initial androgen deprivation therapy, most men respond to second-line hormonal therapies. However, guidelines have neither addressed second-line hormonal therapy for nonmetastatic CRPC nor provided specific guidance with regard to the chemotherapy-naïve population. Recent Data Six phase III randomized controlled trials and expert consensus opinion inform this PCO. Provisional Clinical Opinion For men with CRPC, a castrate state should be maintained indefinitely. Second-line hormonal therapy (eg, antiandrogens, CYP17 inhibitors) may be considered in patients with nonmetastatic CRPC at high risk for metastatic disease (rapid prostate-specific antigen doubling time or velocity) but otherwise is not suggested. In patients with radiographic evidence of metastases and minimal symptoms, enzalutamide or abiraterone plus prednisone should be offered after discussion with patients about potential harms, benefits, costs, and patient preferences. Radium-223 and sipuleucel-T also are options. No evidence provides guidance about the optimal order of hormonal therapies for CRPC beyond second-line treatment. Prostate-specific antigen testing every 4 to 6 months is reasonable for men without metastases. Routine radiographic restaging generally is not suggested but can be considered for patients at risk for metastases or who exhibit symptoms or other evidence of progression. Additional information is available at www.asco.org/genitourinary-cancer-guidelines and www.asco.org/guidelineswiki .

  19. Diagnosis and treatment of bacteremia and endocarditis due to Staphylococcus aureus. A clinical guideline from the Spanish Society of Clinical Microbiology and Infectious Diseases (SEIMC).

    PubMed

    Gudiol, Francesc; Aguado, José María; Almirante, Benito; Bouza, Emilio; Cercenado, Emilia; Domínguez, M Ángeles; Gasch, Oriol; Lora-Tamayo, Jaime; Miró, José M; Palomar, Mercedes; Pascual, Alvaro; Pericas, Juan M; Pujol, Miquel; Rodríguez-Baño, Jesús; Shaw, Evelyn; Soriano, Alex; Vallés, Jordi

    2015-11-01

    Both bacteremia and infective endocarditis caused by Staphylococcus aureus are common and severe diseases. The prognosis may darken not infrequently, especially in the presence of intracardiac devices or methicillin-resistance. Indeed, the optimization of the antimicrobial therapy is a key step in the outcome of these infections. The high rates of treatment failure and the increasing interest in the influence of vancomycin susceptibility in the outcome of infections caused by both methicillin-susceptible and -resistant isolates has led to the research of novel therapeutic schemes. Specifically, the interest raised in recent years on the new antimicrobials with activity against methicillin-resistant staphylococci has been also extended to infections caused by susceptible strains, which still carry the most important burden of infection. Recent clinical and experimental research has focused in the activity of new combinations of antimicrobials, their indication and role still being debatable. Also, the impact of an appropriate empirical antimicrobial treatment has acquired relevance in recent years. Finally, it is noteworthy the impact of the implementation of a systematic bundle of measures for improving the outcome. The aim of this clinical guideline is to provide an ensemble of recommendations in order to improve the treatment and prognosis of bacteremia and infective endocarditis caused by S. aureus, in accordance to the latest evidence published.

  20. The American Thoracic Society methods in epidemiologic, clinical, and operations research program. A research capacity-building program in low- and middle-income countries.

    PubMed

    Buist, A Sonia; Parry, Vivienne

    2013-08-01

    Respiratory diseases are a major cause of morbidity and mortality worldwide. The greatest impact of many of these diseases is felt in low- and middle-income countries, but their control and management is hampered by lack of accurate estimates of their prevalence, risk factors, and distribution, and knowledge of the social and cultural setting in which they occur. Providing enough information for cost-effective response to respiratory diseases requires research by trained investigators and public health personnel. The American Thoracic Society (ATS) Methods in Epidemiologic, Clinical, and Operations Research (MECOR) Program was launched in 1994 to provide a sustainable means of increasing local and national research capacity aimed at addressing this need. As of March 2013, approximately 1,015 students have completed at least one level of the training program. Post-MECOR, 64% of participants have published a medical paper, 79% have presented at a scientific or academic meeting, 51% have submitted a research protocol for funding, and 42% have had one funded. One-quarter have been awarded an academic or clinical fellowship, and 78% reported that MECOR had made a significant or extremely important contribution to their professional life and accomplishments. Future challenges include funding, recruitment of local faculty, helping to build the research infrastructure in MECOR countries, and providing ongoing mentoring for research.

  1. American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer

    PubMed Central

    Hammond, M. Elizabeth H.; Hayes, Daniel F.; Dowsett, Mitch; Allred, D. Craig; Hagerty, Karen L.; Badve, Sunil; Fitzgibbons, Patrick L.; Francis, Glenn; Goldstein, Neil S.; Hayes, Malcolm; Hicks, David G.; Lester, Susan; Love, Richard; Mangu, Pamela B.; McShane, Lisa; Miller, Keith; Osborne, C. Kent; Paik, Soonmyung; Perlmutter, Jane; Rhodes, Anthony; Sasano, Hironobu; Schwartz, Jared N.; Sweep, Fred C.G.; Taube, Sheila; Torlakovic, Emina Emilia; Valenstein, Paul; Viale, Giuseppe; Visscher, Daniel; Wheeler, Thomas; Williams, R. Bruce; Wittliff, James L.; Wolff, Antonio C.

    2010-01-01

    Purpose To develop a guideline to improve the accuracy of immunohistochemical (IHC) estrogen receptor (ER) and progesterone receptor (PgR) testing in breast cancer and the utility of these receptors as predictive markers. Methods The American Society of Clinical Oncology and the College of American Pathologists convened an international Expert Panel that conducted a systematic review and evaluation of the literature in partnership with Cancer Care Ontario and developed recommendations for optimal IHC ER/PgR testing performance. Results Up to 20% of current IHC determinations of ER and PgR testing worldwide may be inaccurate (false negative or false positive). Most of the issues with testing have occurred because of variation in preanalytic variables, thresholds for positivity, and interpretation criteria. Recommendations The Panel recommends that ER and PgR status be determined on all invasive breast cancers and breast cancer recurrences. A testing algorithm that relies on accurate, reproducible assay performance is proposed. Elements to reliably reduce assay variation are specified. It is recommended that ER and PgR assays be considered positive if there are at least 1% positive tumor nuclei in the sample on testing in the presence of expected reactivity of internal (normal epithelial elements) and external controls. The absence of benefit from endocrine therapy for women with ER-negative invasive breast cancers has been confirmed in large overviews of randomized clinical trials. PMID:20404251

  2. American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer

    PubMed Central

    Hammond, M. Elizabeth H.; Hayes, Daniel F.; Dowsett, Mitch; Allred, D. Craig; Hagerty, Karen L.; Badve, Sunil; Fitzgibbons, Patrick L.; Francis, Glenn; Goldstein, Neil S.; Hayes, Malcolm; Hicks, David G.; Lester, Susan; Love, Richard; Mangu, Pamela B.; McShane, Lisa; Miller, Keith; Osborne, C. Kent; Paik, Soonmyung; Perlmutter, Jane; Rhodes, Anthony; Sasano, Hironobu; Schwartz, Jared N.; Sweep, Fred C. G.; Taube, Sheila; Torlakovic, Emina Emilia; Valenstein, Paul; Viale, Giuseppe; Visscher, Daniel; Wheeler, Thomas; Williams, R. Bruce; Wittliff, James L.; Wolff, Antonio C.

    2011-01-01

    Purpose To develop a guideline to improve the accuracy of immunohistochemical (IHC) estrogen receptor (ER) and progesterone receptor (PgR) testing in breast cancer and the utility of these receptors as predictive markers. Methods The American Society of Clinical Oncology and the College of American Pathologists convened an international Expert Panel that conducted a systematic review and evaluation of the literature in partnership with Cancer Care Ontario and developed recommendations for optimal IHC ER/PgR testing performance. Results Up to 20% of current IHC determinations of ER and PgR testing worldwide may be inaccurate (false negative or false positive). Most of the issues with testing have occurred because of variation in preanalytic variables, thresholds for positivity, and interpretation criteria. Recommendations The Panel recommends that ER and PgR status be determined on all invasive breast cancers and breast cancer recurrences. A testing algorithm that relies on accurate, reproducible assay performance is proposed. Elements to reliably reduce assay variation are specified. It is recommended that ER and PgR assays be considered positive if there are at least 1% positive tumor nuclei in the sample on testing in the presence of expected reactivity of internal (normal epithelial elements) and external controls. The absence of benefit from endocrine therapy for women with ER-negative invasive breast cancers has been confirmed in large overviews of randomized clinical trials. PMID:20524868

  3. Liberation From Mechanical Ventilation in Critically Ill Adults: Executive Summary of an Official American College of Chest Physicians/American Thoracic Society Clinical Practice Guideline.

    PubMed

    Schmidt, Gregory A; Girard, Timothy D; Kress, John P; Morris, Peter E; Ouellette, Daniel R; Alhazzani, Waleed; Burns, Suzanne M; Epstein, Scott K; Esteban, Andres; Fan, Eddy; Ferrer, Miguel; Fraser, Gilles L; Gong, Michelle Ng; Hough, Catherine L; Mehta, Sangeeta; Nanchal, Rahul; Patel, Sheena; Pawlik, Amy J; Schweickert, William D; Sessler, Curtis N; Strøm, Thomas; Wilson, Kevin C; Truwit, Jonathon D

    2017-01-01

    This clinical practice guideline addresses six questions related to liberation from mechanical ventilation in critically ill adults. It is the result of a collaborative effort between the American Thoracic Society (ATS) and the American College of Chest Physicians (CHEST). A multidisciplinary panel posed six clinical questions in a population, intervention, comparator, outcomes (PICO) format. A comprehensive literature search and evidence synthesis was performed for each question, which included appraising the quality of evidence using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach. The Evidence-to-Decision framework was applied to each question, requiring the panel to evaluate and weigh the importance of the problem, confidence in the evidence, certainty about how much the public values the main outcomes, magnitude and balance of desirable and undesirable outcomes, resources and costs associated with the intervention, impact on health disparities, and acceptability and feasibility of the intervention. Evidence-based recommendations were formulated and graded initially by subcommittees and then modified following full panel discussions. The recommendations were confirmed by confidential electronic voting; approval required that at least 80% of the panel members agree with the recommendation. The panel provides recommendations regarding liberation from mechanical ventilation. The details regarding the evidence and rationale for each recommendation are presented in the American Journal of Respiratory and Critical Care Medicine and CHEST. Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

  4. Official Executive Summary of an American Thoracic Society/American College of Chest Physicians Clinical Practice Guideline: Liberation from Mechanical Ventilation in Critically Ill Adults.

    PubMed

    Schmidt, Gregory A; Girard, Timothy D; Kress, John P; Morris, Peter E; Ouellette, Daniel R; Alhazzani, Waleed; Burns, Suzanne M; Epstein, Scott K; Esteban, Andres; Fan, Eddy; Ferrer, Miguel; Fraser, Gilles L; Gong, Michelle Ng; L Hough, Catherine; Mehta, Sangeeta; Nanchal, Rahul; Patel, Sheena; Pawlik, Amy J; Schweickert, William D; Sessler, Curtis N; Strøm, Thomas; Wilson, Kevin C; Truwit, Jonathon D

    2017-01-01

    This clinical practice guideline addresses six questions related to liberation from mechanical ventilation in critically ill adults. It is the result of a collaborative effort between the American Thoracic Society and the American College of Chest Physicians. A multidisciplinary panel posed six clinical questions in a Population, Intervention, Comparator, and Outcomes format. A comprehensive literature search and evidence synthesis was performed for each question, which included appraising the certainty in the evidence (i.e., the quality of evidence) using the Grading of Recommendations, Assessment, Development, and Evaluation approach. The Evidence-to-Decision framework was applied to each question, requiring the panel to evaluate and weigh the importance of the problem, the confidence in the evidence, the certainty about how much the public values the main outcomes, the magnitude and balance of desirable and undesirable outcomes, the resources and costs associated with the intervention, the impact on health disparities, and the acceptability and feasibility of the intervention. Evidence-based recommendations were formulated and graded initially by subcommittees and then modified after full-panel discussions. The recommendations were confirmed by confidential electronic voting; approval required that at least 80% of the panel members agree with the recommendation. The panel provides recommendations regarding liberation from mechanical ventilation. The details regarding the evidence and rationale for each recommendation are presented in the American Journal of Respiratory and Critical Care Medicine and Chest.

  5. Autologous chondrocyte implantation (ACI) for cartilage defects of the knee: A guideline by the working group "Clinical Tissue Regeneration" of the German Society of Orthopaedics and Trauma (DGOU).

    PubMed

    Niemeyer, P; Albrecht, D; Andereya, S; Angele, P; Ateschrang, A; Aurich, M; Baumann, M; Bosch, U; Erggelet, C; Fickert, S; Gebhard, H; Gelse, K; Günther, D; Hoburg, A; Kasten, P; Kolombe, T; Madry, H; Marlovits, S; Meenen, N M; Müller, P E; Nöth, U; Petersen, J P; Pietschmann, M; Richter, W; Rolauffs, B; Rhunau, K; Schewe, B; Steinert, A; Steinwachs, M R; Welsch, G H; Zinser, W; Fritz, J

    2016-06-01

    Autologous chondrocyte implantation (ACI) is an established and well-accepted procedure for the treatment of localised full-thickness cartilage defects of the knee. The present review of the working group "Clinical Tissue Regeneration" of the German Society of Orthopaedics and Trauma (DGOU) describes the biology and function of healthy articular cartilage, the present state of knowledge concerning therapeutic consequences of primary cartilage lesions and the suitable indication for ACI. Based on best available scientific evidence, an indication for ACI is given for symptomatic cartilage defects starting from defect sizes of more than three to four square centimetres; in the case of young and active sports patients at 2.5cm(2), while advanced degenerative joint disease needs to be considered as the most important contraindication. The present review gives a concise overview on important scientific background and the results of clinical studies and discusses the advantages and disadvantages of ACI. Non-systematic Review. Copyright © 2016 Elsevier B.V. All rights reserved.

  6. Official Positions for FRAX® clinical regarding international differences from Joint Official Positions Development Conference of the International Society for Clinical Densitometry and International Osteoporosis Foundation on FRAX®.

    PubMed

    Cauley, Jane A; El-Hajj Fuleihan, Ghada; Arabi, Asma; Fujiwara, Saeko; Ragi-Eis, Sergio; Calderon, Andrew; Chionh, Siok Bee; Chen, Zhao; Curtis, Jeffrey R; Danielson, Michelle E; Hanley, David A; Kroger, Heikki; Kung, Annie W C; Lesnyak, Olga; Nieves, Jeri; Pluskiewicz, Wojciech; El Rassi, Rola; Silverman, Stuart; Schott, Anne-Marie; Rizzoli, Rene; Luckey, Marjorie

    2011-01-01

    Osteoporosis is a serious worldwide epidemic. Increased risk of fractures is the hallmark of the disease and is associated with increased morbidity, mortality and economic burden. FRAX® is a web-based tool developed by the Sheffield WHO Collaborating Center team, that integrates clinical risk factors, femoral neck BMD, country specific mortality and fracture data and calculates the 10 year fracture probability in order to help health care professionals identify patients who need treatment. However, only 31 countries have a FRAX® calculator at the time paper was accepted for publication. In the absence of a FRAX® model for a particular country, it has been suggested to use a surrogate country for which the epidemiology of osteoporosis most closely approximates the index country. More specific recommendations for clinicians in these countries are not available. In North America, concerns have also been raised regarding the assumptions used to construct the US ethnic specific FRAX® calculators with respect to the correction factors applied to derive fracture probabilities in Blacks, Asians and Hispanics in comparison to Whites. In addition, questions were raised about calculating fracture risk in other ethnic groups e.g., Native Americans and First Canadians. In order to provide additional guidance to clinicians, a FRAX® International Task Force was formed to address specific questions raised by physicians in countries without FRAX® calculators and seeking to integrate FRAX® into their clinical practice. The main questions that the task force tried to answer were the following: The Task Force members conducted appropriate literature reviews and developed preliminary statements that were discussed and graded by a panel of experts at the ISCD-IOF joint conference. The statements approved by the panel of experts are discussed in the current paper.

  7. Screening, Assessment, and Management of Fatigue in Adult Survivors of Cancer: An American Society of Clinical Oncology Clinical Practice Guideline Adaptation

    PubMed Central

    Bower, Julienne E.; Bak, Kate; Berger, Ann; Breitbart, William; Escalante, Carmelita P.; Ganz, Patricia A.; Schnipper, Hester Hill; Lacchetti, Christina; Ligibel, Jennifer A.; Lyman, Gary H.; Ogaily, Mohammed S.; Pirl, William F.; Jacobsen, Paul B.

    2014-01-01

    Purpose This guideline presents screening, assessment, and treatment approaches for the management of adult cancer survivors who are experiencing symptoms of fatigue after completion of primary treatment. Methods A systematic search of clinical practice guideline databases, guideline developer Web sites, and published health literature identified the pan-Canadian guideline on screening, assessment, and care of cancer-related fatigue in adults with cancer, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines In Oncology (NCCN Guidelines) for Cancer-Related Fatigue and the NCCN Guidelines for Survivorship. These three guidelines were appraised and selected for adaptation. Results It is recommended that all patients with cancer be evaluated for the presence of fatigue after completion of primary treatment and be offered specific information and strategies for fatigue management. For those who report moderate to severe fatigue, comprehensive assessment should be conducted, and medical and treatable contributing factors should be addressed. In terms of treatment strategies, evidence indicates that physical activity interventions, psychosocial interventions, and mind-body interventions may reduce cancer-related fatigue in post-treatment patients. There is limited evidence for use of psychostimulants in the management of fatigue in patients who are disease free after active treatment. Conclusion Fatigue is prevalent in cancer survivors and often causes significant disruption in functioning and quality of life. Regular screening, assessment, and education and appropriate treatment of fatigue are important in managing this distressing symptom. Given the multiple factors contributing to post-treatment fatigue, interventions should be tailored to each patient's specific needs. In particular, a number of nonpharmacologic treatment approaches have demonstrated efficacy in cancer survivors. PMID:24733803

  8. Adjuvant Endocrine Therapy for Women With Hormone Receptor–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Focused Update

    PubMed Central

    Burstein, Harold J.; Temin, Sarah; Anderson, Holly; Buchholz, Thomas A.; Davidson, Nancy E.; Gelmon, Karen E.; Giordano, Sharon H.; Hudis, Clifford A.; Rowden, Diana; Solky, Alexander J.; Stearns, Vered; Winer, Eric P.; Griggs, Jennifer J.

    2014-01-01

    Purpose To update the ASCO clinical practice guideline on adjuvant endocrine therapy on the basis of emerging data on the optimal duration of treatment, particularly adjuvant tamoxifen. Methods ASCO convened the Update Committee and conducted a systematic review of randomized clinical trials from January 2009 to June 2013 and analyzed three historical trials. Guideline recommendations were based on the Update Committee's review of the evidence. Outcomes of interest included survival, disease recurrence, and adverse events. Results This guideline update reflects emerging data on duration of tamoxifen treatment. There have been five studies of tamoxifen treatment beyond 5 years of therapy. The two largest studies with longest reported follow-up show a breast cancer survival advantage with 10-year durations of tamoxifen use. In addition to modest gains in survival, extended therapy with tamoxifen for 10 years compared with 5 years was associated with lower risks of breast cancer recurrence and contralateral breast cancer. Recommendations Previous ASCO guidelines recommended treatment of women who have hormone receptor–positive breast cancer and are premenopausal with 5 years of tamoxifen, and those who are postmenopausal a minimum of 5 years of adjuvant therapy with an aromatase inhibitor or tamoxifen followed by an aromatase inhibitor (in sequence). If women are pre- or perimenopausal and have received 5 years of adjuvant tamoxifen, they should be offered 10 years total duration of tamoxifen. If women are postmenopausal and have received 5 years of adjuvant tamoxifen, they should be offered the choice of continuing tamoxifen or switching to an aromatase inhibitor for 10 years total adjuvant endocrine therapy. PMID:24868023

  9. European Society of Endocrinology Clinical Practice Guideline for long-term follow-up of patients operated on for a phaeochromocytoma or a paraganglioma.

    PubMed

    Plouin, P F; Amar, L; Dekkers, O M; Fassnacht, M; Gimenez-Roqueplo, A P; Lenders, J W M; Lussey-Lepoutre, C; Steichen, O

    2016-05-01

    Phaeochromocytomas and paragangliomas (PPGLs) are rare neuroendocrine tumours. Standard treatment is surgical resection. Following complete resection of the primary tumour, patients with PPGL are at risk of developing new tumoural events. The present guideline aims to propose standardised clinical care of long-term follow-up in patients operated on for a PPGL. The guideline has been developed by The European Society of Endocrinology and based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) principles. We performed a systematic review of the literature and analysed the European Network for the Study of Adrenal Tumours (ENS@T) database. The risk of new events persisted in the long term and was higher for patients with genetic or syndromic diseases. Follow-up in the published cohorts and in the ENS@T database was neither standardised nor exhaustive, resulting in a risk of follow-up bias and in low statistical power beyond 10 years after complete surgery. To inform patients and care providers in this context of low-quality evidence, the Guideline Working Group therefore prepared recommendations on the basis of expert consensus. Key recommendations are the following: we recommend that all patients with PPGL be considered for genetic testing; we recommend assaying plasma or urinary metanephrines every year to screen for local or metastatic recurrences or new tumours; and we suggest follow-up for at least 10 years in all patients operated on for a PPGL. High-risk patients (young patients and those with a genetic disease, a large tumour and/or a paraganglioma) should be offered lifelong annual follow-up. © 2016 European Society of Endocrinology.

  10. Executive summary of management of prosthetic joint infections. Clinical practice guidelines by the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC).

    PubMed

    Ariza, Javier; Cobo, Javier; Baraia-Etxaburu, Josu; Benito, Natividad; Bori, Guillermo; Cabo, Javier; Corona, Pablo; Esteban, Jaime; Horcajada, Juan Pablo; Lora-Tamayo, Jaime; Murillo, Oscar; Palomino, Julián; Parra, Jorge; Pigrau, Carlos; Del Pozo, José Luis; Riera, Melchor; Rodríguez, Dolores; Sánchez-Somolinos, Mar; Soriano, Alex; Del Toro, M Dolores; de la Torre, Basilio

    2017-03-01

    The incidence of prosthetic joint infection (PJI) is expected to increase in the coming years. PJI has serious consequences for patients, and high costs for the health system. The complexity of these infections makes it necessary to organize the vast quantity of information published in the last several years. The indications for the choice of a given surgical strategy and the corresponding antimicrobial therapy are specifically reviewed. The authors selected clinically relevant questions and then reviewed the available literature in order to give recommendations according to a pre-determined level of scientific evidence. The more controversial aspects were debated, and the final composition was agreed at an ad hoc meeting. Before its final publication, the manuscript was made available online in order that all SEIMC members were able to read it and make comments and suggestions. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

  11. Sentinel Lymph Node Biopsy for Patients With Early-Stage Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update.

    PubMed

    Lyman, Gary H; Somerfield, Mark R; Bosserman, Linda D; Perkins, Cheryl L; Weaver, Donald L; Giuliano, Armando E

    2016-12-12

    Purpose To provide current recommendations on the use of sentinel node biopsy (SNB) for patients with early-stage breast cancer. Methods PubMed and the Cochrane Library were searched for randomized controlled trials, systematic reviews, meta-analyses, and clinical practice guidelines from 2012 through July 2016. An Update Panel reviewed the identified abstracts. Results Of the eight publications identified and reviewed, none prompted a change in the 2014 recommendations, which are reaffirmed by the updated literature review. Conclusion Women without sentinel lymph node (SLN) metastases should not receive axillary lymph node dissection (ALND). Women with one to two metastatic SLNs who are planning to undergo breast-conserving surgery with whole-breast radiotherapy should not undergo ALND (in most cases). Women with SLN metastases who will undergo mastectomy should be offered ALND. These three recommendations are based on randomized controlled trials. Women with operable breast cancer and multicentric tumors, with ductal carcinoma in situ, who will undergo mastectomy, who previously underwent breast and/or axillary surgery, or who received preoperative/neoadjuvant systemic therapy may be offered SNB. Women who have large or locally advanced invasive breast cancer (tumor size T3/T4), inflammatory breast cancer, or ductal carcinoma in situ (when breast-conserving surgery is planned) or are pregnant should not undergo SNB.

  12. American Society of Clinical Oncology technology assessment of pharmacologic interventions for breast cancer risk reduction including tamoxifen, raloxifene, and aromatase inhibition.

    PubMed

    Chlebowski, Rowan T; Col, Nananda; Winer, Eric P; Collyar, Deborah E; Cummings, Steven R; Vogel, Victor G; Burstein, Harold J; Eisen, Andrea; Lipkus, Isaac; Pfister, David G

    2002-08-01

    To update an evidence-based technology assessment of chemoprevention strategies for breast cancer risk reduction. POTENTIAL INTERVENTIONS: Tamoxifen, raloxifene, aromatase inhibition, and fenretinide. Outcomes of interest include breast cancer incidence, breast cancer-specific survival, overall survival, and net health benefit. A comprehensive, formal literature review was conducted for relevant topics. Testimony was collected from invited experts and interested parties. The American Society of Clinical Oncology (ASCO) prescribed technology assessment procedure was followed. More weight was given to published randomized trials. BENEFITS/HARMS: A woman's decision regarding breast cancer risk reduction strategies is complex and will depend on the importance and weight attributed to information regarding both cancer- and noncancer-related risks and benefits. For women with a defined 5-year projected breast cancer risk of > or= 1.66%, tamoxifen (at 20 mg/d for 5 years) may be offered to reduce their risk. Risk/benefit models suggest that greatest clinical benefit with least side effects is derived from use of tamoxifen in younger (premenopausal) women (who are less likely to have thromboembolic sequelae and uterine cancer), women without a uterus, and women at higher breast cancer risk. Data do not as yet suggest that tamoxifen provides an overall health benefit or increases survival. In all circumstances, tamoxifen use should be discussed as part of an informed decision-making process with careful consideration of individually calculated risks and benefits. Use of tamoxifen combined with hormone replacement therapy or use of raloxifene, any aromatase inhibitor or inactivator, or fenretinide to lower the risk of developing breast cancer is not recommended outside of a clinical trial setting. This technology assessment represents an ongoing process and recommendations will be updated in a timely matter. The conclusions were endorsed by the ASCO Health Services Research

  13. Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 update by the infectious diseases society of america.

    PubMed

    Freifeld, Alison G; Bow, Eric J; Sepkowitz, Kent A; Boeckh, Michael J; Ito, James I; Mullen, Craig A; Raad, Issam I; Rolston, Kenneth V; Young, Jo-Anne H; Wingard, John R

    2011-02-15

    This document updates and expands the initial Infectious Diseases Society of America (IDSA) Fever and Neutropenia Guideline that was published in 1997 and first updated in 2002. It is intended as a guide for the use of antimicrobial agents in managing patients with cancer who experience chemotherapy-induced fever and neutropenia. Recent advances in antimicrobial drug development and technology, clinical trial results, and extensive clinical experience have informed the approaches and recommendations herein. Because the previous iteration of this guideline in 2002, we have a developed a clearer definition of which populations of patients with cancer may benefit most from antibiotic, antifungal, and antiviral prophylaxis. Furthermore, categorizing neutropenic patients as being at high risk or low risk for infection according to presenting signs and symptoms, underlying cancer, type of therapy, and medical comorbidities has become essential to the treatment algorithm. Risk stratification is a recommended starting point for managing patients with fever and neutropenia. In addition, earlier detection of invasive fungal infections has led to debate regarding optimal use of empirical or preemptive antifungal therapy, although algorithms are still evolving. What has not changed is the indication for immediate empirical antibiotic therapy. It remains true that all patients who present with fever and neutropenia should be treated swiftly and broadly with antibiotics to treat both gram-positive and gram-negative pathogens. Finally, we note that all Panel members are from institutions in the United States or Canada; thus, these guidelines were developed in the context of North American practices. Some recommendations may not be as applicable outside of North America, in areas where differences in available antibiotics, in the predominant pathogens, and/or in health care-associated economic conditions exist. Regardless of venue, clinical vigilance and immediate treatment are

  14. Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 Update by the Infectious Diseases Society of America.

    PubMed

    Freifeld, Alison G; Bow, Eric J; Sepkowitz, Kent A; Boeckh, Michael J; Ito, James I; Mullen, Craig A; Raad, Issam I; Rolston, Kenneth V; Young, Jo-Anne H; Wingard, John R

    2011-02-15

    This document updates and expands the initial Infectious Diseases Society of America (IDSA) Fever and Neutropenia Guideline that was published in 1997 and first updated in 2002. It is intended as a guide for the use of antimicrobial agents in managing patients with cancer who experience chemotherapy-induced fever and neutropenia. Recent advances in antimicrobial drug development and technology, clinical trial results, and extensive clinical experience have informed the approaches and recommendations herein. Because the previous iteration of this guideline in 2002, we have a developed a clearer definition of which populations of patients with cancer may benefit most from antibiotic, antifungal, and antiviral prophylaxis. Furthermore, categorizing neutropenic patients as being at high risk or low risk for infection according to presenting signs and symptoms, underlying cancer, type of therapy, and medical comorbidities has become essential to the treatment algorithm. Risk stratification is a recommended starting point for managing patients with fever and neutropenia. In addition, earlier detection of invasive fungal infections has led to debate regarding optimal use of empirical or preemptive antifungal therapy, although algorithms are still evolving. What has not changed is the indication for immediate empirical antibiotic therapy. It remains true that all patients who present with fever and neutropenia should be treated swiftly and broadly with antibiotics to treat both gram-positive and gram-negative pathogens. Finally, we note that all Panel members are from institutions in the United States or Canada; thus, these guidelines were developed in the context of North American practices. Some recommendations may not be as applicable outside of North America, in areas where differences in available antibiotics, in the predominant pathogens, and/or in health care-associated economic conditions exist. Regardless of venue, clinical vigilance and immediate treatment are

  15. International Society for Cellular Therapy perspective on immune functional assays for mesenchymal stromal cells as potency release criterion for advanced phase clinical trials

    PubMed Central

    Galipeau, Jacques; Krampera, Mauro; Barrett, John; Dazzi, Francesco; Deans, Robert J.; Debruijn, Joost; Dominici, Massimo; Fibbe, Willem E.; Gee, Adrian P.; Gimble, Jeffery M.; Hematti, Peiman; Koh, Mickey B.C.; Leblanc, Katarina; Martin, Ivan; Mcniece, Ian K.; Mendicino, Michael; Oh, Steve; Ortiz, Luis; Phinney, Donald G.; Planat, Valerie; Shi, Yufang; Stroncek, David F.; Viswanathan, Sowmya; Weiss, Daniel J.; Sensebe, Luc

    2016-01-01

    Mesenchymal stromal cells (MSCs) as a pharmaceutical for ailments characterized by pathogenic autoimmune, alloimmune and inflammatory processes now cover the spectrum of early- to late-phase clinical trials in both industry and academic sponsored studies. There is a broad consensus that despite different tissue sourcing and varied culture expansion protocols, human MSC-like cell products likely share fundamental mechanisms of action mediating their anti-inflammatory and tissue repair functionalities. Identification of functional markers of potency and reduction to practice of standardized, easily deployable methods of measurements of such would benefit the field. This would satisfy both mechanistic research as well as development of release potency assays to meet Regulatory Authority requirements for conduct of advanced clinical studies and their eventual registration. In response to this unmet need, the International Society for Cellular Therapy (ISCT) addressed the issue at an international workshop in May 2015 as part of the 21st ISCT annual meeting in Las Vegas. The scope of the workshop was focused on discussing potency assays germane to immunomodulation by MSC-like products in clinical indications targeting immune disorders. We here provide consensus perspective arising from this forum. We propose that focused analysis of selected MSC markers robustly deployed by in vitro licensing and metricized with a matrix of assays should be responsive to requirements from Regulatory Authorities. Workshop participants identified three preferred analytic methods that could inform a matrix assay approach: quantitative RNA analysis of selected gene products; flow cytometry analysis of functionally relevant surface markers and protein-based assay of secretome. We also advocate that potency assays acceptable to the Regulatory Authorities be rendered publicly accessible in an “open-access” manner, such as through publication or database collection. PMID:26724220

  16. Subtrochanteric fractures after long-term treatment with bisphosphonates: a European Society on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis, and International Osteoporosis Foundation Working Group Report

    PubMed Central

    Åkesson, K.; Bouxsein, M.; Kanis, J. A.; Napoli, N.; Papapoulos, S.; Reginster, J.-Y.; Cooper, C.

    2010-01-01

    Summary This paper reviews the evidence for an association between atypical subtrochanteric fractures and long-term bisphosphonate use. Clinical case reports/reviews and case–control studies report this association, but retrospective phase III trial analyses show no increased risk. Bisphosphonate use may be associated with atypical subtrochanteric fractures, but the case is yet unproven. Introduction A Working Group of the European Society on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis and the International Osteoporosis Foundation has reviewed the evidence for a causal association between subtrochanteric fractures and long-term treatment with bisphosphonates, with the aim of identifying areas for further research and providing recommendations for physicians. Methods A PubMed search of literature from 1994 to May 2010 was performed using key search terms, and articles pertinent to subtrochanteric fractures following bisphosphonate use were analysed. Results Several clinical case reports and case reviews report a possible association between atypical fractures at the subtrochanteric region of the femur in bisphosphonate-treated patients. Common features of these ‘atypical’ fractures include prodromal pain, occurrence with minimal/no trauma, a thickened diaphyseal cortex and transverse fracture pattern. Some small case–control studies report the same association, but a large register-based study and retrospective analyses of phase III trials of bisphosphonates do not show an increased risk of subtrochanteric fractures with bisphosphonate use. The number of atypical subtrochanteric fractures in association with bisphosphonates is an estimated one per 1,000 per year. It is recommended that physicians remain vigilant in assessing their patients treated with bisphosphonates for the treatment or prevention of osteoporosis and advise patients of the potential risks. Conclusions Bisphosphonate use may be associated with atypical subtrochanteric

  17. European Society of Gastrointestinal Endoscopy (ESGE): recommendations (2009) on clinical use of video capsule endoscopy to investigate small-bowel, esophageal and colonic diseases.

    PubMed

    Ladas, S D; Triantafyllou, K; Spada, C; Riccioni, M E; Rey, J-F; Niv, Y; Delvaux, M; de Franchis, R; Costamagna, G

    2010-03-01

    These recommendations on video capsule endoscopy, an emerging technology with an impact on the practice of endoscopy, were developed by the European Society of Gastrointestinal Endoscopy (ESGE) Guidelines Committee. The first draft of each section was prepared by one or two members of the writing team, who were selected as experts on the content of that section on the basis of their published work. They used evidence-based methodology, performing MEDLINE and PubMed literature searches to identify relevant clinical studies. Abstracts from scientific meetings were included only if there was no published full paper on a particular topic. If there was disagreement, the first author of the Guideline made the final decision. Recommendations were graded according to the strength of the supporting evidence. The draft guideline was critically reviewed by all authors and submitted to the ESGE councillors for their critical review before approval of the final document. The ESGE Guidelines Committee acknowledges that this document is based on a critical review of the data available at the time of preparation and that further studies may be needed to clarify some aspects. Moreover, this Guideline may be revised as necessary to account for changes in technology, new data, or other aspects of clinical practice. This document should be regarded as supplying recommendations only to gastroenterologists in providing care to their patients. It is not a set of rules and should not be construed as establishing a legal standard of care, or as encouraging, advocating, requiring, or discouraging any particular treatment. These recommendations must be interpreted according to the clinician's knowledge, expertise, and clinical judgment in the management of individual patients and, if necessary, a course of action that varies from recommendations must be undertaken.

  18. Guideline on allergen-specific immunotherapy in IgE-mediated allergic diseases: S2k Guideline of the German Society for Allergology and Clinical Immunology (DGAKI), the Society for Pediatric Allergy and Environmental Medicine (GPA), the Medical Association of German Allergologists (AeDA), the Austrian Society for Allergy and Immunology (ÖGAI), the Swiss Society for Allergy and Immunology (SGAI), the German Society of Dermatology (DDG), the German Society of Oto- Rhino-Laryngology, Head and Neck Surgery (DGHNO-KHC), the German Society of Pediatrics and Adolescent Medicine (DGKJ), the Society for Pediatric Pneumology (GPP), the German Respiratory Society (DGP), the German Association of ENT Surgeons (BV-HNO), the Professional Federation of Paediatricians and Youth Doctors (BVKJ), the Federal Association of Pulmonologists (BDP) and the German Dermatologists Association (BVDD).

    PubMed

    Pfaar, Oliver; Bachert, Claus; Bufe, Albrecht; Buhl, Roland; Ebner, Christof; Eng, Peter; Friedrichs, Frank; Fuchs, Thomas; Hamelmann, Eckard; Hartwig-Bade, Doris; Hering, Thomas; Huttegger, Isidor; Jung, Kirsten; Klimek, Ludger; Kopp, Matthias Volkmar; Merk, Hans; Rabe, Uta; Saloga, Joachim; Schmid-Grendelmeier, Peter; Schuster, Antje; Schwerk, Nicolaus; Sitter, Helmut; Umpfenbach, Ulrich; Wedi, Bettina; Wöhrl, Stefan; Worm, Margitta; Kleine-Tebbe, Jörg; Kaul, Susanne; Schwalfenberg, Anja

    The present guideline (S2k) on allergen-specific immunotherapy (AIT) was established by the German, Austrian and Swiss professional associations for allergy in consensus with the scientific specialist societies and professional associations in the fields of otolaryngology, dermatology and venereology, pediatric and adolescent medicine, pneumology as well as a German patient organization (German Allergy and Asthma Association; Deutscher Allergie- und Asthmabund, DAAB) according to the criteria of the Association of the Scientific Medical Societies in Germany (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF). AIT is a therapy with disease-modifying effects. By administering allergen extracts, specific blocking antibodies, toler-ance-inducing cells and mediators are activated. These prevent further exacerbation of the allergen-triggered immune response, block the specific immune response and attenuate the inflammatory response in tissue. Products for SCIT or SLIT cannot be compared at present due to their heterogeneous composition, nor can allergen concentrations given by different manufacturers be compared meaningfully due to the varying methods used to measure their active ingredients. Non-modified allergens are used for SCIT in the form of aqueous or physically adsorbed (depot) extracts, as well as chemically modified allergens (allergoids) as depot extracts. Allergen extracts for SLIT are used in the form of aqueous solutions or tablets. The clinical efficacy of AIT is measured using various scores as primary and secondary study endpoints. The EMA stipulates combined symptom and medication scores as primary endpoint. A harmonization of clinical endpoints, e. g., by using the combined symptom and medication scores (CSMS) recommended by the EAACI, is desirable in the future in order to permit the comparison of results from different studies. The current CONSORT recommendations from the ARIA/GA2LEN group specify standards for the

  19. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum.

    PubMed

    Gloviczki, Peter; Comerota, Anthony J; Dalsing, Michael C; Eklof, Bo G; Gillespie, David L; Gloviczki, Monika L; Lohr, Joann M; McLafferty, Robert B; Meissner, Mark H; Murad, M Hassan; Padberg, Frank T; Pappas, Peter J; Passman, Marc A; Raffetto, Joseph D; Vasquez, Michael A; Wakefield, Thomas W

    2011-05-01

    The Society for Vascular Surgery (SVS) and the American Venous Forum (AVF) have developed clinical practice guidelines for the care of patients with varicose veins of the lower limbs and pelvis. The document also includes recommendations on the management of superficial and perforating vein incompetence in patients with associated, more advanced chronic venous diseases (CVDs), including edema, skin changes, or venous ulcers. Recommendations of the Venous Guideline Committee are based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system as strong (GRADE 1) if the benefits clearly outweigh the risks, burden, and costs. The suggestions are weak (GRADE 2) if the benefits are closely balanced with risks and burden. The level of available evidence to support the evaluation or treatment can be of high (A), medium (B), or low or very low (C) quality. The key recommendations of these guidelines are: We recommend that in patients with varicose veins or more severe CVD, a complete history and detailed physical examination are complemented by duplex ultrasound scanning of the deep and superficial veins (GRADE 1A). We recommend that the CEAP classification is used for patients with CVD (GRADE 1A) and that the revised Venous Clinical Severity Score is used to assess treatment outcome (GRADE 1B). We suggest compression therapy for patients with symptomatic varicose veins (GRADE 2C) but recommend against compression therapy as the primary treatment if the patient is a candidate for saphenous vein ablation (GRADE 1B). We recommend compression therapy as the primary treatment to aid healing of venous ulceration (GRADE 1B). To decrease the recurrence of venous ulcers, we recommend ablation of the incompetent superficial veins in addition to compression therapy (GRADE 1A). For treatment of the incompetent great saphenous vein (GSV), we recommend endovenous thermal ablation (radiofrequency or laser) rather than high ligation and inversion stripping

  20. Methadone overdose and cardiac arrhythmia potential: findings from a review of the evidence for an American Pain Society and College on Problems of Drug Dependence clinical practice guideline.

    PubMed

    Chou, Roger; Weimer, Melissa B; Dana, Tracy

    2014-04-01

    The number of deaths associated with methadone use increased dramatically in parallel with marked increases in its use, particularly for treatment of chronic pain. To develop a clinical guideline on methadone prescribing to reduce potential harms, the American Pain Society commissioned a review of various aspects related to methadone safety. This article summarizes evidence related to unintentional overdose due to methadone and harms related to cardiac arrhythmia potential. We searched Ovid MEDLINE, the Cochrane Library, and PsycINFO databases through January 2014 for studies assessing harms associated with methadone use; we judged 70 studies to be relevant and to meet inclusion criteria. The majority of studies on overdose and cardiac arrhythmia risk are observational and provide weak evidence on which to base clinical guidelines. In patients prescribed methadone for treatment of opioid dependence, data suggest that mortality benefits related to reduction in illicit drug use outweigh harms. Despite epidemiologic data showing marked increases in the numbers of methadone-related deaths that have been primarily attributed to increased use of methadone for chronic pain, evidence on methadone and mortality risk in this population has been somewhat contradictory. There is some evidence that recent initiation of methadone, psychiatric admissions, and concomitant use of benzodiazepines are associated with a higher risk for overdose. Evidence on cardiac risks is primarily limited to case reports of torsades de pointes, primarily in patients on high doses of methadone, and to studies showing an association between methadone use and prolongation of QTc intervals. Research is needed to understand the effectiveness of dosing methods, electrocardiogram monitoring, and other risk mitigation strategies in patients prescribed methadone. This systematic review synthesizes the evidence related to methadone use and risk for overdose and cardiac arrhythmia. Findings regarding the

  1. Asthma and allergy: short texts and recommendations of the expert conference of the French Speaking Pneumology Society (SPLF), in partnership with the French Society of Allergology and Clinical Immunology (SFAIC), the French Society of Occupational Medicine (SFMT) and the "Asthma-Allergy" association.

    PubMed

    Tillie-Leblond, Isabelle; Magnan, Antoine; Pauli, Gabrielle; Vervloet, Daniel; Wallaert, Benoît; Didier, Alain; Ameille, Jacques; Godard, Philippe

    2008-10-01

    The Asthma Plan published by the French Health Ministry in 2002, the experts conferences edited by ANAES on therapeutic education and follow-up of asthma, the inclusion of this disease in the Public Health Law have been remarkable steps in France during the last few years. The medical community, more particularly the pneumological community, has shown its commitment in the treatment of this public health problem. But allergy was not sufficiently taken into account, although it is responsible for nearly 50 to 60% cases of asthma. In most so-called developed countries the prevalence of asthma and of allergies has increased in the last twenty years. Its progress varies according to country and age group: the increased prevalence of allergy, more specifically of rhinitis and eczema, is most marked in children aged 6-7 year. The prevalence of asthma seems to have reached a plateau in certain northern countries or seems to have decreased in 13-14 year olds (Anglo-Saxon countries). There were multiple reasons, generally attributed to changes in life-style. Asthma is the result of an interaction between a genetic predisposition and the environment, where allergens are present, but also smoking. The relationships between allergy and asthma are complex. This conference discussed the various essential issues that face doctors who treat patients with asthma in their daily practice. The risk factors, the methods of exploration in children and adults and the specific treatments are, indeed, essential issues to be evaluated in a frequent pathology that interests a large number of physicians. The variety of experts is wide, representing pneumology (French Speaking Pneumology Society), the occupational medicine world (French Society of Occupational Medicine), the allergic pathology (French Society of Allergology and Clinical Immunology), and patients with the patient association "Asthma & Allergy", physicians belonging to the general medicine community, general hospitals, private

  2. The Janes Surgical Society

    PubMed Central

    O’Brien, Stephen E.; Carrie, Alan W.; Palmer, Charles R.

    1999-01-01

    The Janes Surgical Society was formed in 1953 by surgeons who had undertaken their surgical training during the tenure of Dr. Robert M. Janes, Professor of Surgery at the University of Toronto from 1947 to 1957. Over the next 35 years, this unique Canadian surgical society met annually at surgical centres on this continent and abroad as well as at certain resort areas from time to time. Members of the Janes Surgical Society could be found in major clinical and academic positions across the country from St. John’s to Victoria. Their annual meetings served a dual purpose: they provided a forum for the exchange of scientific knowledge and ideas by the members; and they provided an opportunity for members and their wives to socialize and renew old friendships dating back to their residency days and to establish new relationships with surgeons and their wives from other countries, including the United States, United Kingdom, France and Sweden. Unfortunately, owing to death and retirements of its members, the Society can no longer hold scientific meetings and travel to distant centres. Its sole activity is now an annual dinner in Toronto, when members and their wives gather to recall the highlights and experiences in their lives that this unique surgical society provided. PMID:10459335

  3. Methodological background and strategy for the 2012-2013 updated consensus definitions and clinical practice guidelines from the abdominal compartment society.

    PubMed

    Kirkpatrick, Andrew W; Roberts, Derek J; Jaeschke, Roman; De Waele, Jan J; De Keulenaer, Bart L; Duchesne, Juan; Bjorck, Martin; Leppäniemi, Ari; Ejike, Janeth C; Sugrue, Michael; Cheatham, Michael L; Ivatury, Rao; Ball, Chad G; Reintam Blaser, Annika; Regli, Adrian; Balogh, Zsolt; D'Amours, Scott; De Laet, Inneke; Malbrain, Manu L N G

    2015-01-01

    The Abdominal Compartment Society (www.wsacs.org) previously created highly cited Consensus Definitions/Management Guidelines related to intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS). Implicit in this previous work, was a commitment to regularly reassess and update in relation to evolving research. Two years preceding the Fifth World Congress on Abdominal Compartment Syndrome, an International Guidelines committee began preparation. An oversight/steering committee formulated key clinical questions regarding IAH/ /ACS based on polling of the Executive to redundancy, structured according to the Patient, Intervention, Comparator, and Outcome (PICO) format. Scientific consultations were obtained from Methodological GRADE experts and a series of educational teleconferences were conducted to educate scientific review teams from among the wscacs. org membership. Each team conducted systematic or structured reviews to identify relevant studies and prepared evidence summaries and draft Grades of Recommendation Assessment, Development and Evaluation (GRADE) recommendations. The evidence and draft recommendations were presented and debated in person over four days. Updated consensus definitions and management statements were derived using a modified Delphi method. A writingcommittee subsequently compiled the results utilizing frequent Internet discussion and Delphi voting methods to compile a robust online Master Report and a concise peer-reviewed summarizing publication. A dedicated Paediatric Guidelines Subcommittee reviewed all recommendations and either accepted or revised them for appropriateness in children. Of the original 12 IAH/ACS definitions proposed in 2006, three (25%) were accepted unanimously, with four (33%) accepted by > 80%, and four (33%) accepted by > 50%, but required discussion to produce revised definitions. One (8%) was rejected by > 50%. In addition to previous 2006 definitions, the panel also defined the open

  4. American Society of Clinical Oncology 2006 update of the breast cancer follow-up and management guidelines in the adjuvant setting.

    PubMed

    Khatcheressian, James L; Wolff, Antonio C; Smith, Thomas J; Grunfeld, Eva; Muss, Hyman B; Vogel, Victor G; Halberg, Francine; Somerfield, Mark R; Davidson, Nancy E

    2006-11-01

    To update the 1999 American Society of Clinical Oncology (ASCO) guideline on breast cancer follow-up and management in the adjuvant setting. An ASCO Expert Panel reviewed pertinent information from the literature through March 2006. More weight was given to studies that tested a hypothesis directly relating testing to one of the primary outcomes in a randomized design. The evidence supports regular history, physical examination, and mammography as the cornerstone of appropriate breast cancer follow-up. All patients should have a careful history and physical examination performed by a physician experienced in the surveillance of cancer patients and in breast examination. Examinations should be performed every 3 to 6 months for the first 3 years, every 6 to 12 months for years 4 and 5, and annually thereafter. For those who have undergone breast-conserving surgery, a post-treatment mammogram should be obtained 1 year after the initial mammogram and at least 6 months after completion of radiation therapy. Thereafter, unless otherwise indicated, a yearly mammographic evaluation should be performed. Patients at high risk for familial breast cancer syndromes should be referred for genetic counseling. The use of CBCs, chemistry panels, bone scans, chest radiographs, liver ultrasounds, computed tomography scans, [18F]fluorodeoxyglucose-positron emission tomography scanning, magnetic resonance imaging, or tumor markers (carcinoembryonic antigen, CA 15-3, and CA 27.29) is not recommended for routine breast cancer follow-up in an otherwise asymptomatic patient with no specific findings on clinical examination. Careful history taking, physical examination, and regular mammography are recommended for appropriate detection of breast cancer recurrence.

  5. Screening, Assessment, and Care of Anxiety and Depressive Symptoms in Adults With Cancer: An American Society of Clinical Oncology Guideline Adaptation

    PubMed Central

    Andersen, Barbara L.; DeRubeis, Robert J.; Berman, Barry S.; Gruman, Jessie; Champion, Victoria L.; Massie, Mary Jane; Holland, Jimmie C.; Partridge, Ann H.; Bak, Kate; Somerfield, Mark R.; Rowland, Julia H.

    2014-01-01

    Purpose A Pan-Canadian Practice Guideline on Screening, Assessment, and Care of Psychosocial Distress (Depression, Anxiety) in Adults With Cancer was identified for adaptation. Methods American Society of Clinical Oncology (ASCO) has a policy and set of procedures for adapting clinical practice guidelines developed by other organizations. The guideline was reviewed for developmental rigor and content applicability. Results On the basis of content review of the pan-Canadian guideline, the ASCO panel agreed that, in general, the recommendations were clear, thorough, based on the most relevant scientific evidence, and presented options that will be acceptable to patients. However, for some topics addressed in the pan-Canadian guideline, the ASCO panel formulated a set of adapted recommendations based on local context and practice beliefs of the ad hoc panel members. It is recommended that all patients with cancer be evaluated for symptoms of depression and anxiety at periodic times across the trajectory of care. Assessment should be performed using validated, published measures and procedures. Depending on levels of symptoms and supplementary information, differing treatment pathways are recommended. Failure to identify and treat anxiety and depression increases the risk for poor quality of life and potential disease-related morbidity and mortality. This guideline adaptation is part of a larger survivorship guideline series. Conclusion Although clinicians may not be able to prevent some of the chronic or late medical effects of cancer, they have a vital role in mitigating the negative emotional and behavioral sequelae. Recognizing and treating effectively those who manifest symptoms of anxiety or depression will reduce the human cost of cancer. PMID:24733793

  6. Calculating Length of Gestation from the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS) Database Versus Vital Records May Alter Reported Rates of Prematurity

    PubMed Central

    Stern, Judy E.; Kotelchuck, Milton; Luke, Barbara; Declercq, Eugene; Cabral, Howard; Diop, Hafsatou

    2014-01-01

    Objective To compare length of gestation following ART as calculated by three methods from the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS) and vital records (birth and fetal death) in the Massachusetts Pregnancy to Early Life Longitudinal Data System (PELL). Design Historical cohort study Setting Database linkage analysis Patients Live or stillborn deliveries Interventions None Main Outcome Measures ART deliveries were l