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Mary Lou Smith and Cynthia Chauhan

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Judy Perotti, Elda Railey, Mary Lou Smith and Cheya Pope

After many decades of academia- and government-driven research in the cancer arena, patient advocates are beginning to play an influential role in the research process. Historically, advocates were not broadly included in research discussions and decision-making, or they were involved as token representatives of the patient community, often without the knowledge or ability to actually influence research. Although this trend has been reversing slowly, as cooperative groups and other institutions make efforts to incorporate advocates in research, many issues must still be resolved. Questions include: Are all patient communities represented by the advocates who currently participate in these venues? How knowledgeable are those advocates about the fundamentals of research and science? Even more importantly, how productive are the discussions between advocates and researchers, and can advocates actually influence the direction of cancer research? Involving advocates in all aspects of cancer care has a huge upside. The patient advocacy movement has changed the face of cancer research by doubling National Institutes of Health (NIH) funding, assisting in the development of the innovative Department of Defense (DOD) research program, and lobbying federal and state governments to provide insurance coverage of new drugs and routine patient care costs in clinical trials and to create treatment appeals mechanisms. Patient advocates have also provided invaluable input into selected research processes, with increasing numbers of advocates within the patient community pushing for more inclusion in this realm. As the involvement of advocates in research expands, so does the need for training and support to educate and...
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Therese Bevers, Kirsten Bibbins-Domingo, Kevin C. Oeffinger and Mary Lou Smith

A panel discussion on controversies in breast cancer screening held recently at the NCCN 21st Annual Conference included only a few controversies. Representatives of the U.S. Preventive Services Task Force, American Cancer Society, and NCCN disagreed primarily on 2 main areas: when to start screening (ages 40, 45, or 50 years) and frequency of screening (annual vs biennial). Panelists from these organizations presented the rationales for their respective recommendations.

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David S. Ettinger, Michael Kuettel, Jennifer Malin, Joan S. McClure, Mary Lou Smith, Andrew D. Zelenetz and F. Marc Stewart

Much has changed in the treatment of cancer since the first NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) were rolled out for 8 different tumor types in November 1996. NCCN Guidelines now include involved algorithms often containing multiple treatment alternatives and detailed pathways of care that depend on more-specific patient characteristics and molecular tumor diagnostics. With 47 different individual NCCN panels, all members of the cancer care team are now better informed than ever to guide patients through the often complex decision-making required to improve the odds of successful outcomes. At the NCCN 20th Annual Conference, a distinguished panel assembled to take a closer look at these invaluable clinical practice guidelines, first glancing backward to how it all started and then forward to explore the key ingredients of trustworthy guidelines.

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Elizabeth A. Nardi, James McCanney, Katy Winckworth-Prejsnar, Alyssa A. Schatz, Kerin Adelson, Marcus Neubauer, Mary Lou Smith, Ronald Walters and Robert W. Carlson

Quality measurement in oncology is increasing in significance as payment schemes shift from volume to value. As demand for quality measures increases, challenges in the development of quality measures, standardization across measures, and the limitations of health information technology have become apparent. Moreover, the time and financial burden associated with developing, tracking, and reporting quality measures are substantial. Despite these challenges, best practices and leaders in the field of quality measurement in oncology have emerged. To understand the current challenges and promising practices in quality measurement and to explore future considerations for measure development and measure reporting in oncology, NCCN convened the NCCN Policy Summit: Redefining Quality Measurement in Oncology. The summit included discussion of the current quality landscape and efforts to develop quality measures, use of quality measures in various programs, patient perspective of quality, and challenges and best practices for quality reporting.

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Therese B. Bevers, Benjamin O. Anderson, Ermelinda Bonaccio, Sandra Buys, Mary B. Daly, Peter J. Dempsey, William B. Farrar, Irving Fleming, Judy E. Garber, Randall E. Harris, Alexandra S. Heerdt, Mark Helvie, John G. Huff, Nazanin Khakpour, Seema A. Khan, Helen Krontiras, Gary Lyman, Elizabeth Rafferty, Sara Shaw, Mary Lou Smith, Theodore N. Tsangaris, Cheryl Williams and Thomas Yankeelov

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Robert W. Carlson, D. Craig Allred, Benjamin O. Anderson, Harold J. Burstein, W. Bradford Carter, Stephen B. Edge, John K. Erban, William B. Farrar, Andres Forero, Sharon Hermes Giordano, Lori J. Goldstein, William J. Gradishar, Daniel F. Hayes, Clifford A. Hudis, Britt-Marie Ljung, P. Kelly Marcom, Ingrid A. Mayer, Beryl McCormick, Lori J. Pierce, Elizabeth C. Reed, Mary Lou Smith, George Somlo, Neal S. Topham, John H. Ward, Eric P. Winer and Antonio C. Wolff

Overview The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer: Noninvasive and Special Situations presented here are the work of the NCCN Breast Cancer panel members. Categories of evidence and consensus were assessed and are noted in the algorithms and text. Although not explicitly stated at every decision point of the guidelines, patient participation in prospective clinical trials is the preferred option of treatment for all stages of breast cancer. These NCCN Guidelines focus on noninvasive breast cancer and special situations, such as Paget's disease, phyllodes tumor, breast cancer during pregnancy, and axillary breast cancer. Another NCCN guideline addresses invasive breast cancer (see NCCN Clinical Practice Guidelines in Oncology [NCCN Guidelines] for Breast Cancer: Invasive and Inflammatory; to view the complete and most recent version of these guidelines, visit the NCCN Web site at www.NCCN.org). The American Cancer Society estimates that 194,280 new cases of invasive breast cancer were diagnosed and 40,610 died of the disease in the United States in 2009.1 In addition, approximately 62,280 women were diagnosed with carcinoma in situ of the breast during the same year. Breast cancer is the most common malignancy in women in the United States and is second only to lung cancer as a cause of cancer death. The incidence of breast cancer has increased steadily in the United States over the past few decades, but breast cancer mortality seems to be declining,1,2 suggesting a benefit from early detection and more effective treatment. The origin of most breast cancer...
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Robert W. Carlson, D. Craig Allred, Benjamin O. Anderson, Harold J. Burstein, W. Bradford Carter, Stephen B. Edge, John K. Erban, William B. Farrar, Lori J. Goldstein, William J. Gradishar, Daniel F. Hayes, Clifford A. Hudis, Mohammad Jahanzeb, Krystyna Kiel, Britt-Marie Ljung, P. Kelly Marcom, Ingrid A. Mayer, Beryl McCormick, Lisle M. Nabell, Lori J. Pierce, Elizabeth C. Reed, Mary Lou Smith, George Somlo, Richard L. Theriault, Neal S. Topham, John H. Ward, Eric P. Winer and Antonio C. Wolff

Breast Cancer Clinical Practice Guidelines in Oncology NCCN Categories of Evidence and Consensus Category 1: The recommendation is based on high-level evidence (e.g., randomized controlled trials) and there is uniform NCCN consensus. Category 2A: The recommendation is based on lower-level evidence and there is uniform NCCN consensus. Category 2B: The recommendation is based on lower-level evidence and there is nonuniform NCCN consensus (but no major disagreement). Category 3: The recommendation is based on any level of evidence but reflects major disagreement. All recommendations are category 2A unless otherwise noted. The Breast Cancer Clinical Practice Guidelines presented here are the work of the members of the NCCN Breast Cancer Clinical Practice Guidelines Panel. Categories of evidence were assessed and are noted on the algorithms and in the text. Although not explicitly stated at every decision point of the Guidelines, patient participation in prospective clinical trials is the preferred option of treatment for all stages of breast cancer. The full breast cancer guidelines are not printed in this issue of JNCCN, but can be accessed online at www.nccn.org. Clinical trials: The NCCN believes that the best management for any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged. Overview The American Cancer Society estimated that 184,450 new cases of invasive breast cancer would be diagnosed and 40,930 patients would die of the disease in the United States in 2008.1 In addition, approximately 67,770 women will be diagnosed with carcinoma in situ of the breast during the same...
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Robert W. Carlson, D. Craig Allred, Benjamin O. Anderson, Harold J. Burstein, W. Bradford Carter, Stephen B. Edge, John K. Erban, William B. Farrar, Andres Forero, Sharon Hermes Giordano, Lori J. Goldstein, William J. Gradishar, Daniel F. Hayes, Clifford A. Hudis, Britt-Marie Ljung, David A. Mankoff, P. Kelly Marcom, Ingrid A. Mayer, Beryl McCormick, Lori J. Pierce, Elizabeth C. Reed, Jasgit Sachdev, Mary Lou Smith, George Somlo, John H. Ward, Antonio C. Wolff and Richard Zellars

Overview These NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer are the work of the members of the NCCN Breast Cancer Panel. Categories of evidence and consensus were assessed and are noted in the algorithms and text. Although not explicitly stated at every decision point of the NCCN Guidelines, patient participation in prospective clinical trials is the preferred option of treatment for all stages of breast cancer. The full breast cancer guidelines are not printed in this issue of JNCCN, but can be accessed online at www.NCCN.org. The American Cancer Society estimated that 209,060 new cases of invasive breast cancer were diagnosed and 40,230 people died of breast cancer in the United States in 2010.1 In addition, approximately 54,010 women were diagnosed with carcinoma in situ of the breast during the same year. Breast cancer is the most common malignancy in women in the United States and is second only to lung cancer as a cause of cancer death. The incidence of breast cancer has increased steadily in the United States over the past few decades, but breast cancer mortality seems to be declining,1,2 suggesting a benefit from early detection and more effective treatment. The cause of most breast cancer cases is unknown. However, numerous risk factors for the disease have been established, including female gender, increasing patient age, family history of breast cancer at a young age, early menarche, late menopause, older age at first live birth, prolonged hormone replacement therapy, previous exposure to therapeutic chest...
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Therese B. Bevers, Mark Helvie, Ermelinda Bonaccio, Kristine E. Calhoun, Mary B. Daly, William B. Farrar, Judy E. Garber, Richard Gray, Caprice C. Greenberg, Rachel Greenup, Nora M. Hansen, Randall E. Harris, Alexandra S. Heerdt, Teresa Helsten, Linda Hodgkiss, Tamarya L. Hoyt, John G. Huff, Lisa Jacobs, Constance Dobbins Lehman, Barbara Monsees, Bethany L. Niell, Catherine C. Parker, Mark Pearlman, Liane Philpotts, Laura B. Shepardson, Mary Lou Smith, Matthew Stein, Lusine Tumyan, Cheryl Williams, Mary Anne Bergman and Rashmi Kumar

The NCCN Guidelines for Breast Cancer Screening and Diagnosis have been developed to facilitate clinical decision making. This manuscript discusses the diagnostic evaluation of individuals with suspected breast cancer due to either abnormal imaging and/or physical findings. For breast cancer screening recommendations, please see the full guidelines on NCCN.org.