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Evidence-based medicine for rare diseases: Implications for data interpretation and clinical trial design

cancer control 2007年第2期14卷 160-166页

作者： Behera, Madhusmita Kumar, Ambuj Soares, Heloisa P. Sokol, Lubomir Djulbegovic, Benjamin Department of Cancer Prevention and Control H. Lee Moffitt Cancer Center Research Institute Tampa FL United States Malignant Hematology Program H. Lee Moffitt Cancer Center Research Institute Tampa FL United States Malignant Hematology Program H. Lee Moffitt Cancer Center and Research Institute Tampa FL 33612 12902 Magnolia Drive United States

Background: The randomized, controlled trial (RCT) is the "gold standard" for establishing the effect of any intervention. This approach, however, is often not feasible with rare diseases such as cutaneous T-cell lymphoma. Methods: We review the principles of evidence-based medicine to see which are particularly pertinent to the study of rare diseases. Results: When an RCT is not feasible, attention is given to determining all the available prior data. Evaluation of the new data and the historic base requires attention to biases, but can allow estimation of a "true" study result. Conclusions: Even when an RCT cannot be performed because of insufficient cases, utilization of evidence-based methodology can help minimize bias and maximize the truth of observed new data.

关键词： .establish interpretation evidence-based cell lymphoma Rare Diseases biases true treatment

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Discussion of fertility preservation with newly diagnosed patients: oncologists' views

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Journal of cancer Survivorship 2007年第2期1卷 146-155页

作者： Quinn, Gwendolyn P. Vadaparampil, Susan T. Gwede, Clement K. Miree, Cheryl King, Lindsey M. Clayton, Heather B. Wilson, Crystal Munster, Pamela Department of Interdisciplinary Oncology College of Medicine University of South Florida Tampa FL United States Department of Cancer Prevention and Control Health Outcomes and Behavior H. Lee Moffitt Cancer Center and Research Institute MRC-CANCONT Tampa FL 33612 12902 Magnolia Drive United States Department of Community and Family Health College of Public Health University of South Florida Tampa FL United States Comprehensive Breast Program H. Lee Moffitt Cancer Center and Research Institute Tampa FL United States Experimental Therapeutics H. Lee Moffitt Cancer Center and Research Institute Tampa FL United States

Although physician discussion with patients regarding fertility preservation (FP) options prior to cancer treatment can provide important information for survivors concerning their future fertility, little is known about the extent to which physicians discuss FP with patients. This qualitative study sought to identify current physician FP communication practices and determine factors that may impact communication efforts regarding FP. Qualitative data were collected using semi structured interviews with 16 physicians practicing at a major cancer center in the South. All providers were board certified in medical oncology, radiation oncology or surgical oncology. The main factors that emerged from qualitative analysis included distinct variations in quality of discussion about FP, knowledge of FP resources, attitudes, practice behaviors and perceptions of patient characteristics. While most physicians discussed potential fertility loss as a side effect of cancer treatment, few provided information to patients about preserving fertility. Patient characteristics such as gender and cancer site may impact the discussion, as well as system factors such as costs of procedures and access to FP resources. Education and training for physicians about FP options for cancer patients, particularly females, may promote discussion of FP. In addition, system barriers related to availability and affordability of FP resources must also be addressed. Physicians should consider providing patients with timely, understandable information related to their FP options, prior to the administration of treatment. Such discussions may lead to improved quality of life for individuals as they transition from patients to survivors. © Springer Science+Business Media, LLC 2007.

关键词： Fertility preservation Patient-physician communication Qualitative research Survivorship

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Influenza a (H1N1) virus resistance to cyanovirin-N arises naturally during adaptation to mice and by passage in cell culture in the presence of the inhibitor

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Antiviral Chemistry and Chemotherapy 2007年第6期18卷 317-327页

作者： Smee, Donald F. Wandersee, Miles K. Checketts, Melissa B. Saucedo, Carrie Boyd, Michael R. Mishin, Vasiliy P. Gubareva, Larisa V. Institute for Antiviral Research Utah State University Logan UT United States Molecular Targets Development Program Center for Cancer Research NCI-Frederick Frederick MD United States Cancer Research Institute College of Medicine University of South Alabama Mobile AL United States University of Virginia Health Science Center Charlottesville VA United States Department of Infectious Diseases St. Jude Children's Research Hospital Memphis TN United States Virus Surveillance and Diagnosis Branch Influenza Division Centers for Disease Control and Prevention Atlanta GA United States

Influenza A/New Caledonia/20/99 (H1N1) virus was studied for development of resistance to cyanovirin-N (CVN). CVN neutralizes virus infectivity by binding to specific high-mannose oligosaccharides on the viral haemagglutinin 1 (HA1) subunit. During virus adaptation to mice in the absence of CVN treatment the virus became resistant to CVN (CVN-MR virus), as did virus passaged in cell culture in the presence of CVN (CVN-R virus). The CVN-R virus possessed a single amino acid change at position 94a (Asn94aAsp) of HA1 that eliminated this glycosylation site. The CVN-MR virus at mouse passage 7 was a mixture of clones, consisting of a single mutation (Asp225Gly) and double mutations (Asn63Ser+Asp225Gly or Asn94a+Asp225Gly), eliminating glycosylation sites. CVN did not bind well to the CVN-R and CVN-MR viruses. Propagating these viruses in cells treated with 1 mM deoxymannojirimycin (dMJ, mannosidase inhibitor) increased sensitivity to CVN, suggesting that glycans attached at other sites on HA1 that typically are not high-mannosidic became so due to dMJ treatment. Further evaluation showed that the Asp225Gly mutant virus was sensitive to the inhibitor and did not kill mice or induce weight loss. The CVN-R virus was also avirulent to mice. The double-mutant CVN-MR viruses were resistant to CVN and caused deaths and severe weight loss in mice. CVN-R virus subjected to mouse adaptation acquired the 225 mutation and a lethal phenotype. Thus, the 225 mutation in the HA receptor-binding site in combination with a loss of glycan at Asn (63 or 94a) are important for mouse adaptation in this virus. The mutations reported here causing resistance to CVN are consistent with its known mode of action. ©2008 International Medical Press.

关键词： Collectins Haemagglutinin Mutations Neutralization Oligomannose

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Survival among COPD patients using fluticasone/salmeterol in combination versus other inhaled steroids and bronchodilators alone

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COPD: Journal of Chronic Obstructive Pulmonary Disease 2007年第2期4卷 127-134页

作者： Mapel, Douglas W. Nelson, Leila S. Lydick, Eva Soriano, Joan Yood, Marianne Ulcickas Davis, Kourtney J. Lovelace Clinic Foundation Albuquerque NM 87106 United States Program of Epidemiology Fundació Caubet-Cimera International Centre for Advanced Respiratory Medicine Recinte Hospital Joan March Bunyola Mallorca Illes Balears Spain Cancer Epidemiology Prevention and Control Henry Ford Health System and Epidemiology and Public Health Yale University School of Medicine Hamden CT 06518 United States GlaxoSmithKline Res. Triangle Park NC 27709-3398 United States Lovelace Clinic Foundation Albuquerque NM 87106-4264 2309 Renard Place SE United States

Recent retrospective studies have suggested that use of inhaled corticosteroids (ICS) may improve survival in chronic obstructive pulmonary disease (COPD), particularly when combined with a long-acting beta-agonist (LABA). However, the study methodologies have been questioned, and no study has examined the survival effect of the newer combination ICS/LABA inhalers. The goal of this project was to further examine the relationship between ICS treatment, with or without LABA, and survival in COPD. COPD patients were identified from the administrative databases of four different integrated health care delivery systems. All patients who were diagnosed with COPD between September 1, 2000 and August 31, 2001 and who had at least 3 months treatment with either a combined fluticasone/salmeterol inhaler (FSI, N = 866), any ICS used with a LABA (ICS/LABA, N = 525), ICS alone (N = 742), LABA alone (N = 531), or a short-acting bronchodilator alone (SABD, N = 1832), were included. Analyses were conducted using three different analysis approaches that adjust for various biases that may affect the results. In the basic Cox proportional hazards models, use of FSI, ICS/LABA, ICS alone, and LABA alone had significant survival benefits as compared to SABD, after adjustment for differences in age, gender, comorbidities, asthma status, and disease severity (HRs 0.61 [0.45-0.83], 0.59 [0.46-0.77], 0.76 [0.61-0.95], 0.75 [0.57-0.98], respectively). Propensity score matching to reduce the clinical differences between the treatment groups versus the SABD reference group found very similar results. Nested case-control analyses, which are based on survival status instead of treatment, continued to show a significant survival benefit for FSI, ICS/LABA, and ICS alone. Treatment with FSI or another ICS with or without LABA is associated with improved survival in COPD. The treatment benefit is reproducible and is robust to application of a number of different analysis techniques designed to adjust

关键词： OBSTRUCTIVE lung diseases STEROIDS BRONCHODILATOR agents ADRENOCORTICAL hormones RESPIRATORY obstructions

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Workshop on imaging science development for cancer prevention and preemption

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cancer Biomarkers 2007年第1期3卷 1-33页

作者： Kelloff, Gary J. Sullivan, Daniel C. Baker, Houston Clarke, Lawrence P. Nordstrom, Robert Tatum, James L. Dorfman, Gary S. Jacobs, Paula Berg, Christine D. Pomper, Martin G. Birrer, Michael J. Tempero, Margaret Higley, Howard R. Petty, Brenda Gumbs Sigman, Caroline C. Maley, Carlo Sharma, Prateek Wax, Adam Ginsberg, Gregory G. Dannenberg, Andrew J. Hawk, Ernest T. Messing, Edward M. Grossman, H. Barton Harisinghani, Mukesh Bigio, Irving J. Griebel, Donna Henson, Donald E. Fabian, Carol J. Ferrara, Katherine Fantini, Sergio Schnall, Mitchell D. Zujewski, Jo Anne Hayes, Wendy Klein, Eric A. DeMarzo, Angelo Ocak, Iclal Ketterling, Jeffrey A. Tempany, Clare Shtern, Faina Parnes, Howard L. Gomez, Jorge Srivastava, Sudhir Szabo, Eva Lam, Stephen Seibel, Eric J. Massion, Pierre McLennan, Geoffrey Cleary, Kevin Suh, Robert Burt, Randall W. Pfeiffer, Ruth M. Hoffman, John M. Roy, Hemant K. Wang, Thomas Limburg, Paul J. El-Deiry, Wafik S. Papadimitrakopoulou, Vali Hittelman, Walter N. MacAulay, Calum Veltri, Robert W. Solomonzz, Diane Jeronimo, Jose Richards-Kortum, Rebecca Johnson, Karen A. Viner, Jaye L. Stratton, Steven P. Rajadhyaksha, Milind Dhawan, Atam NIH/NCI/DCTD Cancer Imaging Program Bethesda MD United States NIH/NCI/DCTD Cancer Imaging Program NCI-Frederick Frederick MD United States NIH/NCI/DCP Early Detection Research Group Bethesda MD United States The Johns Hopkins University School of Medicine Departments of Radiology Pharmacology and Oncology Division of Neuroradiology Baltimore MD United States NIH/NCI/CCR Cell and Cancer Biology Branch Bethesda MD United States University of California San Francisco Department of Medicine Division of Medical Oncology San Francisco CA United States CCS Associates Inc. Mountain View CA United States Wistar Institute Molecular and Cellular Oncogenesis Program Philadelphia PA United States University of Kansas School of Medicine VA Hospital Kansas City MO United States Duke University Department of Biomedical Engineering Medical Physics Program Durham NC United States University of Pennsylvania School of Medicine Department of Gastroenterology Philadelphia PA United States New York Presbyterian Hospital Weill Medical College of Cornell University New York NY United States NIH/NCI/OD Office of Centers for Training and Resources Bethesda MD United States University of Rochester Medical Center Department of Urology Rochester NY United States University of Texas MD Anderson Cancer Center Department of Urology Houston TX United States Massachusetts General Hospital Abdominal Imaging/Interventional Radiology Boston MA United States Boston University Biomedical Engineering Electrical and Computer Engineering and Physics Boston MA United States NIH/NCI/DCP Gastrointestinal and Other Cancers Research Group Bethesda MD United States The George Washington University Cancer Institute Office of Cancer Prevention and Control Washington DC United States University of Kansas Cancer Center Clinical Oncology Kansas City KS United States University of California Davis Department of Biomedical Engineering Davis CA United States Tufts University De

The article provides information on a workshop on the development of imaging systems for cancer prevention and preemption convened by the U.S. National cancer Institute (NCI) cancer Imaging program held in Gaithersburg, Maryland. Doctor Katherine Ferrara of the University of California discussed the function of ultrasound in breast tumor imaging. Ways to close the gap between development and application of imaging approaches were tackled in a roundtable discussion on cervix and skin cancer.

关键词： FORUMS (Discussion & debate) IMAGING systems in medicine cancer prevention

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cancer, Culture and Literacy 5th Biennial Conference: Solutions for Addressing Health Disparities through Community Partnerships: May 18—20, 2006, Clearwater Beach, Florida: Conference Highlights

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cancer control 2006年第4期13卷 304 - 305页

作者： Chrystyna Pospolyta Dina Martinez Janelle Menard Cathy D. Meade Division of Cancer Prevention & Control Health Outcomes & Behavior Program at the H. Lee Moffitt Cancer Center & Research Institute Tampa Florida.

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Dose escalation of a curcuminoid formulation

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BMC Complementary and Alternative Medicine 2006年第1期6卷 1-4页

作者： Lao, Christopher D. Ruffin IV, Mack T. Normolle, Daniel Heath, Dennis D. Murray, Sandra I. Bailey, Joanne M. Boggs, Martha E. Crowell, James Rock, Cheryl L. Brenner, Dean E. Division of Hematology-Oncology Department of Internal Medicine University of Michigan Ann Arbor MI 48109-0930 2150 CCGC United States Department of Family Medicine University of Michigan Ann Arbor MI 48109-0708 1018 Fuller St. United States Department of Biostatistics Core Cancer Center University of Michigan Ann Arbor MI 48109-0473 300 North Ingalls Bldg. United States Cancer Prevention and Control Program University of California San Diego La Jolla CA 92093-0901 9500 Gilman Drive United States Division of Cancer Prevention National Cancer Institute Bethesda MD 20892 9000 Rockville Pike United States Department of Family and Preventive Medicine University of California San Diego La Jolla CA 92093-0901 9500 Gilman Drive United States

Background: Curcumin is the major yellow pigment extracted from turmeric, a commonly-used spice in India and Southeast Asia that has broad anticarcinogenic and cancer chemopreventive potential. However, few systematic studies of curcumin's pharmacology and toxicology in humans have been performed. Methods: A dose escalation study was conducted to determine the maximum tolerated dose and safety of a single dose of standardized powder extract, uniformly milled curcumin (C³ Complex™ Sabinsa Corporation). Healthy volunteers were administered escalating doses from 500 to 12,000 Mg. Results: Seven of twenty-four subjects (30%) experienced only minimal toxicity that did not appear to be dose-related. No curcumin was detected in the serum of subjects administered 500, 1,000, 2,000, 4,000, 6,000 or 8,000 mg. Low levels of curcumin were detected in two subjects administered 10,000 or 12,000 mg. Conclusion: The tolerance of curcumin in high single oral doses appears to be excellent. Given that achieving systemic bioavailability of curcumin or its metabolites may not be essential for colorectal cancer chemoprevention, these findings warrant further investigation for its utility as a long-term chemopreventive agent. © 2006 Lao et al;licensee BioMed Central Ltd.

关键词： Curcumin Minimal Toxicity Poor Bioavailability Common Toxicity Criterion Version Single Dose Oral Administration

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Chapter 25: Education, training, and communication for HPV vaccines

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Vaccine 2006年第SUPPL. 3期24卷 S210-S218页

作者： Sherris, Jacqueline Friedman, Allison Wittet, Scott Davies, Philip Steben, Marc Saraiya, Mona Program for Appropriate Technology in Health (PATH) Seattle WA 98107 1455 NW Leary Way United States Division of STD Prevention Centers for Disease Control and Prevention Atlanta GA United States European Cervical Cancer Association Lyon France Médecin Conseil Groupe Aviseur Sur Le VPH Institut National De Santé Publique Du Québec Montreal Canada Division of Cancer Prevention and Control Centers for Disease Control and Prevention Atlanta GA United States

As human papillomavirus (HPV) vaccines come to market, they will face education and training challenges similar to those of other new vaccines, along with HPV-specific issues. Recent studies document stark knowledge gaps about HPV at all levels - among policy makers, healthcare providers, parents, and teens - in both the industrialized and developing worlds. Pharmaceutical companies, public health advocates, medical trainers, and health educators need to understand their diverse audiences and respond appropriately to the needs of each. They also must use research-based communication strategies and materials to most effectively, and accurately, convey the need for an HPV vaccine and to manage expectations about how the vaccine can, and cannot, protect women and men. © 2006 Elsevier Ltd. All rights reserved.

关键词： Cervical cancer Education HPV Training Vaccines

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Distribution of Male Genital System cancers (MGSC), United States – 1999–2001

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Annals of Epidemiology 2005年第8期15卷 633-634页

作者： R.R. German T.D. Thompson S.L. Stewart P.A. Wingo National Program of Cancer Registries (NPCR) Centers for Disease Control and Prevention (CDC) Atlanta GA

Purpose MGSC comprise nearly a third of all cancers in males. Prostate cancer (PrC) is the most commonly diagnosed cancer among males, and the second leading cause of cancer-related deaths. Testicular cancer (TsC) is the most common solid tumor among males aged 15–34 years. Penile (PnC) and other MGSC are uncommon. Recent national population-based data can further characterize these cancers. Methods Incidence data from 38 CDC-NPCR registries and 5 Surveillance, Epidemiology, and End Results (SEER) registries (i.e., 91% of the US), and mortality data from CDC's National Center for Health Statistics (100% of the United States), were used to calculate age-specific and age-adjusted rates in 1999–2001 for the United States. Results About 96% and 98% of MGSC cases and deaths, respectively, were PrC. Incidence and death rates of PnC increased with increasing age, as well as incidence rates of other MGSC. PrC rates increased up to 70–79 years, where incidence declined but mortality continued to increase. TsC rates peaked at about 30-39 years, where incidence declined while mortality declined then increased at 80+ years. Compared to white males, age-adjusted incidence and death rates among black males were about twice as high for PrC and five to two times lower for TsC. Rates of PnC and other MGSC did not vary appreciably by white/black race. Analysis of age-adjusted PrC rates by census region showed the Northeast (NE) having the highest incidence rate and the Midwest (MW) and South (S) with the highest death rates. PnC incidence rates were highest in the NE and MW, while PnC death rates were highest in the MW and S. The West had the highest death rates for TsC and the highest incidence rates for other MGSC. TsC incidence rates and other MGSC death rates did not vary appreciably by Census region. Conclusions Demographic variations in the occurrence of uncommon MGSC were observed. Additional analyses by stage, histology, and grade are planned.

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Scale and shape issues in focused cluster power for count data

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International Journal of Health Geographics 2005年第3期4卷 8-8页

作者： Puett, Robin C. Lawson, Andrew B. Clark, Allan B. Aldrich, Tim E. Porter, Dwayne E. Feigley, Charles E. Hebert, James R. Department of Epidemiology and Biostatistics Arnold School of Public Health University of South Carolina Columbia SC United States Department of Environmental Health Sciences Arnold School of Public Health University of South Carolina Columbia SC United States School of Medicine Health Policy and Practice University of East Anglia East Anglia United Kingdom South Carolina Statewide Cancer Prevention and Control Program Hollings Cancer Center Medical University of South Carolina Charleston SC United States

Background: Interest in the development of statistical methods for disease cluster detection has experienced rapid growth in recent years. Evaluations of statistical power provide important information for the selection of an appropriate statistical method in environmentally-related disease cluster investigations. Published power evaluations have not yet addressed the use of models for focused cluster detection and have not fully investigated the issues of disease cluster scale and shape. As meteorological and other factors can impact the dispersion of environmental toxicants, it follows that environmental exposures and associated diseases can be dispersed in a variety of spatial patterns. This study simulates disease clusters in a variety of shapes and scales around a centrally located single pollution source. We evaluate the power of a range of focused cluster tests and generalized linear models to detect these various cluster shapes and scales for count data. Results: In general, the power of hypothesis tests and models to detect focused clusters improved when the test or model included parameters specific to the shape of cluster being examined (i.e. inclusion of a function for direction improved power of models to detect clustering with an angular effect). However, power to detect clusters where the risk peaked and then declined was limited. Conclusion: Findings from this investigation show sizeable changes in power according to the scale and shape of the cluster and the test or model applied. These findings demonstrate the importance of selecting a test or model with functions appropriate to detect the spatial pattern of the disease cluster. © 2005 Puett et al;licensee BioMed Central Ltd.

关键词： Power Evaluation Power Curve Pollution Dispersion Cluster Shape Disease Cluster

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