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GST Primary GST Primary Best Strategies for Health Care Quality Im... Best Strategies for Health Care Quality Improvement - Diabetes Quality Improvement Strategies for Antibio... Kathryn McDonald, Stanford-UCSF Evidence-b... Systematic review assessing the effect of ... Quality Improvement Strategies for Antibiotics Management Kathryn McDonald, Stanford-UCSF Evidence-based Practice Center, 117 Encina Commons, Stanford, CA 94305-6019, Kathy.mcdonald@stanford.edu Systematic review assessing the effect of quality improvement strategies on appropriate prescribing of antibiotics and appropriate choice of antibiotics. Adherence Adherence Assistive Devices Assistive Devices Childhood Burn Hanson MacMillan Childhood Burn Hanson MacMillan CLSA_9 CLSA_9 Cyberabuse Cyberabuse Cognitive Behavioural Therapy for Violent ... This review included randomized trials abo... Cognitive Behavioural Therapy for Violent Men who Batter Their Partners This review included randomized trials about the effects of cognitive behavioral therapy on domestic violence. The intervention included programs based on the Duluth Model. The violence had to be committed by a male toward his female partner. The violence also had to be physical. The primary outcomes were new arrests and convictions, and new reports of violence. CABG vs PCI CABG vs PCI Quality Improvement Strategies for Prevent... Quality Improvement Strategies for Preventing Nosocomial Infections (Created 17-Feb-06) Quality Improvement Strategies for Asthma ... Quality Improvement Strategies for Asthma Control Erectile Dysfunction (Created 30-Jan-06) Erectile Dysfunction (Created 30-Jan-06) Inequality - Smoking Cessation to Reduce S... This review was the first part of a projec... Inequality - Smoking Cessation to Reduce Socio-Economic Differences This review was the first part of a project about inequality. It included randomized trials about the effect of smoking cessation interventions on reducing socio-economic differences. The studies had to report data either on persons with low socio-economic groups status or, preferably, on both low and high socio-economic groups. Diet and Physical Activity to Reduce Socio... This review was the second part in a proje... Diet and Physical Activity to Reduce Socio-Economic Differences This review was the second part in a project about inequality. It included randomized trials about the effect of interventions on reducing socio-economic differences in diet and physical activity. The studies had to report data either on persons with low socio-economic groups status or, preferably, on both low and high socio-economic groups. Workfare The data in SRS are not identical to the d... Workfare The data in SRS are not identical to the data in the published report. We used SRS only for an updated search. The review included randomized trials about the effect of welfare-to-work programs. Participants were welfare recipients. There were basically two types of programs. The educational type tried to build knowledge and skills in order to help the welfare recipients acquire jobs that could support them economically. The "work first" approach was more aimed at getting the participants quickly into a job. Exercise interventions for the management ... The objective of this systematic review wa... Exercise interventions for the management of frailty The objective of this systematic review was to examine the effectiveness of current exercise interventions on the management of frailty. A comprehensive search of Medline, Embase, Psycinfo, Cinahl, Scopus, Ageline, Eric, and SportDiscus databases was conducted and produced 1808 citations. So far we have completed 2 levels of “title and abstract” screening and we ended up with 262 articles. We have just started the full text screening. Eligibility criteria included original studies whose participants were identified as frail or prefrail with specific criteria and in which structured physical activity was included as at least one component of the intervention. Create a free account, build a dictionary with saved terms to re-use later! Public Domestic Violence - Using Cognitive Behavior Therapy Smoking Cessation to Reduce Socio-Economic Differences Diet and Physical Activity to Reduce Socio-Economic Differences Workfare Exercise Interventions for the Management of Frailty Search     Simple Advanced Refine (5 coded questions)  Any of these:   Exact Phrase: All of these: None of these: Author: Periodical: Projects: No restrictions   Libraries: Public   Select SRS Projects Show Saved Terms Select Library Show articles that do not have abstracts  Humans or Animals Humans Animals Type of Article Clinical Trial Editorial Letter Meta-Analysis Practice Guideline Randomized Controlled Trial Review Addresses Bibliography Biography Case Reports Classical Article Clinical Conference Clinical Trial, Phase I Clinical Trial, Phase II Clinical Trial, Phase III Clinical Trial, Phase IV Comment Comparative Study Consensus Development Conference Consensus Development Conference, NIH Controlled Clinical Trial Corrected and Republished Article Dictionary Directory Duplicate Publication English Abstract Evaluation Studies Festschrift Government Publications Guideline Historical Article Interview In Vitro Journal Article Lectures Legal Cases Legislation Multicenter Study News Newspaper Article Overall Patient Education Handout Periodical Index Published Erratum Retracted Publication Research Support, N.I.H., Extramural Research Support, N.I.H., Intramural Research Support, Non-U.S. Gov't Research Support, U.S. Gov't, Non-P.H.S. 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Retraction of Publication Scientific Integrity Review Support of Research Technical Report Twin Study Validation Studies Not a Primary Study or Review Unknown Primary Study Case Series Case Control Cohort Study Observational Study Qualitative Research CBA or ITS Registry Double Blind Controlled before after study Quasi-randomized trial Simple before after study Cluster-RCT Non-Randomized Study Report Book Book chapter Dissertation Conference procedings Secondary Research Not RCT Language English French German Italian Japanese Russian Spanish Afrikaans Albanian Unknown Arabic Armenian Azerbaijani Bosnian Bulgarian Catalan Chinese Croatian Czech Danish Dutch Esperanto Estonian Finnish Georgian Greek, Modern Hebrew Hindi Hungarian Icelandic Indonesian Kinyarwanda Korean Latin Latvian Lithuanian Macedonian Malay Malayalam Maori Multiple Languages Norwegian Persian Polish Portuguese Pushto Romanian Sanskrit Scottish gaelic Serbian Slovak Slovenian Swedish Thai Turkish Ukrainian Vietnamese Not English Not French Ages All Infant: birth-23 months All Child: 0-18 years All Adult: 19+ years Newborn: birth-1 month Infant: 1-23 months Preschool Child: 2-5 years Child: 6-12 years Adolescent: 13-18 years Adult: 19-44 years Middle Aged: 45-64 years Middle Aged + Aged: 45+ years Aged: 65+ years 80 and over: 80+ years Undetermined Intervention Patient education Communication and counselling Patient involvement through self-monitoring Reminders Reinforcement or rewards Other (e.g. combined education and reminders) Unknown Educational Materials Group threrapy Couples threrapy Individual threrapy Healthy eating Increased physical activity Not Diet or Exercise Welfare-to-work program Results(1-25 of 1,270) Sort By: Publication Date Relevance Took: 2.055 seconds to search 17,750,454  Action: Copy Results to new Clipboard Build Search Link Page 1 of 51 1 2 3 4 > Last >> (1270 articles found) American Society of Clinical Oncology policy statement: oversight of clinical research. Jun 15, 2003 American Society of Clinical Oncology 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 confide... ( view more )nce 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 understanding of clinical research oversight. 6. Enhance the efficiency and cost-effectiveness of the clinical research oversight system. This policy statement makes recommendations in several areas that serve as principles to support an improved system of oversight for clinical research. ASCO will work with all parties involved in the clinical research system to develop the steps necessary to implement these recommendations. Centralized Trial Review: A large percentage of oncology clinical trials are coordinated through the National Cancer Institute's (NCI) system of cooperative groups, which already incorporates centralized scientific review. As such, there is a tremendous opportunity to employ a centralized mechanism to provide ethical review by highly trained IRB members, allowing local IRBs to take advantage of the financial and time efficiencies that central review provides. Centralized review boards (CRBs) would also contribute consistency and efficiency to the process. Once successfully completed, the review would represent an approval to open the protocol at all of the institutions that have subscribed to the centralized review system. Local IRBs would be able to devote time usually spent on initial review to ongoing monitoring of the trial taking place at their institution. Considering the enormous size and complexity of the clinical research enterprise, ASCO envisions multiple CRBs, which could be distributed as regional review boards. Central review will use a single protocol and consent form, and monitor and evaluate adverse events (AEs) on a global basis, eliminating many of the time-consuming steps for the local IRB. Global monitoring and assessment of AEs has real potential to enhance trial participants' safety by giving local institutions more information on the overall trial and enabling them to devote more time to ongoing review of the trial onsite. Use of a CRB also has real potential to reduce the costs of clinical trial oversight by allowing local IRBs to eliminate the costs of initial review. These efficiencies will likely lead to institutions redirecting funds toward monitoring ongoing trials. Although a CRB has potential to improve the efficiency of the process, a CRB could also have tremendous ability to delay valuable trials. Checks and balances must be included in the newly devised system to ensure timely review and appeals of CRB actions. ASCO proposes the advent of a new pilot program for centralizing review of clinical trials. It requires clear engagement of all stakeholders in planning the experiment, clear articulation of the goals, and assurance of federal regulatory protection for institutions choosing to participate. If successful, this CRB pilot project could be expanded to include multi-institutional industry-sponsored research. Education and Training:Education and training are critical to the ultimate success of an improved oversight system. All members of the research team should receive comprehensive education on conducting scientifically and ethically valid clinical research. The curriculum should also include information on the prevailing local and federal regulations that pertain to the clinical trials process. IRB members should also receive ongoing education and training in the review of clinical research protocols. IRB training should pay particular attention to nonscientific members to give them the tools necessary to speak on behalf of research participants. ASCO should develop a curriculum that focuses on the proper conduct of human research and emphasize ethically sound clinical research in the context of its Annual Meeting. Informed Consent: Investigators and review boards have specific roles to play in ensuring the education of trial participants through the informed consent process, both when they are considering trial enrollment and as they participate in the trial. Review boards and investigators should focus primarily on the informed consent process, rather than the informed consent documents. Federal Oversight: The federal government has an important role to play in the oversight of clinical research. This role should be expanded to cover all research, not just that which is funded by the federal government or conducted with the oversight of the Food and Drug Administration (FDA). The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the FDA should provide clear regulatory support and guidance for local institutions that choose to employ a CRB. In the case of the pilot CRB discussed in this policy statement, it should serve as the preferred option for the cancer cooperative group clinical trials. Ideally, the federal government should unify and streamline its regulations for the oversight of clinical research. Resources Supporting Clinical Research Infrastructure:An effective oversight process demands the highest quality scientific and ethical review and onsite monitoring of the safety of trial participants. This can only be accomplished by the involvement of an experienced IRB that receives funding, resources, and institutional support enabling it to fulfill its mandate. Conflict of Interest: Critical to the integrity of research is the absence of bias in the process. ASCO strongly recommends the adoption of standards for the identification, management, and, where appropriate, elimination of conflicts of interests, whether they are actual, potential, or apparent. ( view less ) View Full Abstract View Article Details View Coded Data Related Articles Guidelines for resident training in veterinary clinical pathology. I. Clinical chemistry. 2003 Mary M Christopher,Tracy Stokol,Leslie Sharkey,Education Committee of the American Society for Veterinary Clinical Pathology BACKGROUND: The Education Committee of the American Society for Veterinary Clinical Pathology identified a need for improved structure and guidance of clinical pathology resident training in clinical chemistry. OBJECTIVES: The committee's goal was to develop learning objectives and competencies in ... ( view more )knowledge, abilities, and skills in clinical chemistry; provide options and ideas for training activities; and identify clinical chemistry resources useful for clinical pathology faculty, training program coordinators, and residents. METHODS: Guidelines were developed and written with the input of Education Committee members and peer experts. RESULTS: The primary objectives of clinical chemistry training are: 1) to accrue a thorough, extensive, and relevant knowledge base of the types, principles, and properties of clinical chemistry tests and concepts of pathophysiology in animals; 2) to develop abilities to reason, think critically, and exercise judgment in clinical chemistry data interpretation, investigative problem-solving, and hypothesis-driven research; and 3) to acquire technical and statistical skills important in clinical chemistry and laboratory operations. CONCLUSIONS: These guidelines define expected competencies that will help ensure proficiency, leadership, and the advancement of knowledge in veterinary clinical chemistry and provide a useful framework for didactic and clinical activities in resident training programs. The learning objectives can readily be adapted to institutional and individual needs, interests, goals, and resources. ( view less ) View Full Abstract View Article Details View Coded Data Related Articles A clinical development paradigm for cancer vaccines and related biologics. Jan 2007 Axel Hoos,Giorgio Parmiani,Kristen Hege,Mario Sznol,Hans Loibner,Alexander Eggermont,Walter Urba,Brent Blumenstein,Natalie Sacks,Ulrich Keilholz,Geoffrey Nichol,Cancer Vaccine Clinical Trial Working Group Therapeutic cancer vaccines are a heterogeneous group of complex biologics with distinctly different clinical characteristics than cytotoxic agents. The current clinical development paradigm used for oncology drug development is based on criteria developed for cytotoxic agents. More flexible and fo... ( view more )cused developmental guidelines are needed to address the unique characteristics of therapeutic cancer vaccines. Over the course of 1 year, the Cancer Vaccine Clinical Trial Working Group, representing academia and the pharmaceutical and biotechnology industries with participation from the US Food and Drug Administration, defined in a consensus process the cornerstones of a new clinical development paradigm for cancer vaccines and related biologics. Four major topics were addressed: (1) end points for clinical trials, (2) trial designs and statistical methods, (3) technical and developmental challenges, and (4) combination therapy.The proposed paradigm suggests therapeutic cancer vaccines to be investigated in 2 general types of clinical studies: proof-of-principle trials and efficacy trials. Proof-of-principle trials, which introduce a novel cancer vaccine into humans, should include a minimum of 20 or more patients in a homogenous, well-defined population in an adjuvant setting or without rapidly progressive disease in a metastatic setting to allow vaccines adequate time to induce biologic activity and should incorporate immune and molecular markers. Objectives should include initiation of a safety database, determination of dose and schedule, and demonstration of biologic activity as proof-of-principle. Biologic activity is defined as any effect of the vaccine on the target disease or host immune system using biologic markers as study end points, for example, clinical, molecular, or immune response. Immune response is demonstrated if determined in 2 separate, established and reproducible assays at 2 consecutive follow-up time points after the baseline assessment. If proof-of-principle trials show such immune response, or other biologic or clinical activity, efficacy trials may be initiated. If none of these end points is met, the clinical development plan should be reevaluated to decide if further development is warranted. Efficacy trials formally establish clinical benefit either directly or through a surrogate and are encouraged to be randomized studies. This is in contrast to single-arm phase 2 trials used for cytotoxic agents, which often use tumor response rate as the primary end point and historical controls as a comparator. Efficacy trials may use prospectively planned adaptive designs to expand from randomized phase 2 into phase 3 studies if well-defined trigger-point criteria are met, but the cost of incorporating such design elements should be carefully evaluated. Efficacy trials can also be exploratory randomized phase 2 trials or conventional phase 3 trials. In addition, conventional clinical end points can be adjusted to account for biologic features of cancer vaccines. The concept of efficacy trials allows for an early assessment of vaccine efficacy based on credible prospective data. This 2-phase developmental paradigm supports a more flexible, expeditious, and focused clinical developmental process with early and informed decision making. In addition, this report addresses clinical development challenges and issues for combination therapies. ( view less ) View Full Abstract View Article Details View Coded Data Related Articles [Evaluation on the functions and cost of 'fever clinics' during the period of severe acute respiratory syndrome epidemics in Beijing] Nov 2003 Dong Zhao,Beijing Health Bureau Fever Clinic Project Team OBJECTIVE: To identify the experiences and lessons learned on 'fever clinics' during the severe acute respiratory syndrome (SARS) epidemic in Beijing and to propose a better model in monitoring SARS to fit the 'fever clinics' into current situation. METHODS: Both qualitative and quantitative method... ( view more )s were used in data collection and analyses. Quantitative surveys would include 1. The setting, functions and administration of current 63 'fever clinics' in Beijing; 2. Survey on patients with fever who had visited 'fever clinics' and randomly selected from the 63 fever clinics; 3. Survey on physicians working in the 'fever clinics'. Qualitative studies would include discussion or interview with administrators, physicians working in the 'fever clinics' and field studies on 23 randomly selected 'fever clinics' as well as telephone interview to the staff working in the hospitals that did not have the 'fever clinics'. RESULTS: A couple of significant problems raised during the study including: 1. Low coverage of current surveillance system. 89% of the hospitals were not covered by the surveillance system which reflecting the misjudgment on the patients with fever that they would only attend 'fever clinics' to seek for medical help. The fact was that most of the hospitals where 'fever clinics' had not been set also received patients with fever. 2. Information related to patients with fever needs to improve regarding its completeness and accuracy. 3. Significant unbalance in daily cost and effectiveness in most of the 'fever clinics' was noticed. CONCLUSION: 'Fever clinics' needs to be adjusted to meet the possible SARS epidemic in coming winter and spring. Short-term and long-term suggestions were proposed regarding SARS monitoring through the functions of 'fever clinics' in Beijing. ( view less ) View Full Abstract View Article Details View Coded Data Related Articles Variation in clinical practice in genitourinary medicine clinics in the United Kingdom. Jun 2003 C A Carne,E Foley,D Rowen,P Kell,R Maw,British Co-operative Clinical Group of the Medical Society for the Study of Venereal Diseases OBJECTIVES: This study was conducted to examine the variation in clinical practice in genitourinary medicine clinics in the United Kingdom in early 2002. METHODS: Questionnaires were sent to all 234 consultants in charge of genitourinary medicine clinics in the United Kingdom in March-May 2002. The... ( view more ) questions concerned clinical practice in respect of asymptomatic patients presenting for an infection screen, and practice in respect of some specific sexually transmitted and other genitourinary infections. RESULTS: The test for infection least likely to be offered to heterosexuals is an HIV test (71% and 70% of clinics routinely offer this to male and female heterosexuals respectively). The practice of permitting "low risk" patients to telephone for their HIV results now extends to 24% of clinics. 34% of clinics do not require patients with non-specific urethritis to attend for follow up. 41% of clinics routinely ask patients treated for Chlamydia trachomatis to return for a follow up chlamydia detection test. 25% of clinics routinely offer two tests of cure to all patients with gonorrhoea. 6% of clinics do not routinely offer syphilis serology to heterosexuals. Other significant variations in clinical practice were documented. CONCLUSIONS: Overall, our findings indicate the need for further evidence to guide clinical practice and a wider knowledge and debate of national guidelines. ( view less ) View Full Abstract View Article Details View Coded Data Related Articles Defining Clinical Improvement in Adult and Juvenile Myositis. Mar 2003 Lisa G Rider,Edward H Giannini,Michael Harris-Love,Galen Joe,David Isenberg,Clarissa Pilkington,Peter A Lachenbruch,Frederick W Miller,International Myositis Assesment and Clinical Studies Group The lack of consensus regarding outcome measures and trial design issues in the idiopathic inflammatory myopathies (IIM) is inhibiting the conduct and interpretation of clinical trials. To begin to address these problems, a multispecialty group of over 70 adult and pediatric neurologists, rheumatol... ( view more )ogists, rehabilitation medicine physicians, statisticians, and patient support group leaders, called the International Myositis Outcome Assessment Collaborative Study Group (IMACS), is engaged in developing consensus on the assessment of disease activity and damage for myositis clinical trials. As part of this ongoing international effort, members of this group met in November 2001 at a work-shop entitled "Defining Clinical Improvement in Adult and Juvenile Myositis." A goal of the work-shop was to review current data on the validity and responsiveness of the recently published proposed preliminary core set measures for disease outcome assessment in clinical trials for myositis and to define the degree of change in each core set measure that is clinically meaningful. Despite differences in the clinical presentations, natural history and responses to therapy between adult onset and juvenile onset myositis, expert specialists in these diseases came to a consensus that the amount of improvement that is clinically meaningful in each core measure is the same for adult and juvenile myositis. For the domains of muscle strength and physical function, a minimum of 15% improvement is clinically significant, whereas for the physician and patient global assessments, as well as the extramuscular assessment, a minimum of 20% improvement is considered clinically meaningful, and for serum levels of muscle associated enzymes, at least 30% improvement is needed to be clinically important. This workshop is the first of several planned to develop multidisciplinary, international consensus on the conduct and reporting of IIM clinical trials. ( view less ) View Full Abstract View Article Details View Coded Data Related Articles Clinical cancer advances 2007: major research advances in cancer treatment, prevention, and screening--a report from the American Society of Clinical Oncology. Jan 10, 2008 Julie Gralow,Robert F Ozols,Dean F Bajorin,Bruce D Cheson,Howard M Sandler,Eric P Winer,James Bonner,George D Demetri,Walter Curran,Patricia A Ganz,Barnett S Kramer,Mark G Kris,Maurie Markman,Robert J Mayer,Derek Raghavan,Scott Ramsey,Gregory H Reaman,Raymond Sawaya,Lynn M Schuchter,John W Sweetenham,Linda T Vahdat,Nancy E Davidson,Richard L Schilsky,Allen S Lichter,American Society of Clinical Oncology 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 ... ( view more )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 threat of a 10% budget cut, the nation's Clinical Trials Cooperative Groups reduced the number of patients participating in clinical trials by almost 2,000 and senior researchers report that many of the brightest young minds no longer see the promise of a career in science, choosing other careers instead. It's time to renew the nation's commitment to cancer research. Without additional support, the opportunity to build on the extraordinary progress to date will be lost or delayed. This report demonstrates the essential role that clinical cancer research plays in finding new and better ways to care for the more than 1.4 million people expected to be diagnosed with cancer this year. I want to thank the Editorial Board members, the Specialty Editors, and the ASCO Cancer Communications Committee for their dedicated work to develop this report. I hope you find it useful. Sincerely, Nancy E. Davidson, MD President American Society of Clinical Oncology. ( view less ) View Full Abstract View Article Details View Coded Data Related Articles Purpose, use, and preparation of clinical practice guidelines for the management of biliary tract and ampullary carcinomas. 2008 Tadahiro Takada,Masaru Miyazaki,Shuichi Miyakawa,Kazuhiro Tsukada,Masato Nagino,Satoshi Kondo,Junji Furuse,Hiroya Saito,Toshio Tsuyuguchi,Fumio Kimura,Hideyuki Yoshitomi,Satoshi Nozawa,Masahiro Yoshida,Keita Wada,Hodaka Amano,Fumihiko Miura,Japanese Association of Billiary Surgery ,Japanese Society of Hepato-Billiary-Pancreatic Surgery ,Japan Society of Clinical Oncology Apart from periampullary carcinoma, the prognosis of biliary tract carcinomas, including hilar cholangiocarcinoma, extrahepatic biliary tract carcinoma, and gallbladder carcinoma, remains poor. Sophisticated diagnostic skills and treatment methods and their application are naturally required to ach... ( view more )ieve better treatment results for biliary tract carcinomas. However, it is not too much to say that, due to the paucity of high-level evidence for the management of these carcinomas, medical care by healthcare providers in clinics and at medical institutes throughout the world is currently delivered without common consensus and common standards. The clinical practice guidelines for the management of biliary carcinoma outlined here were produced with the aim that they could be used by physicians involved in the care of biliary tract carcinomas, as indicators that could help them provide their patients with the most appropriate care possible at this time. Also, the guidelines were prepared to provide measures that could assure patients with biliary tract carcinomas of safe medical care. The present guidelines are characterized by their clarification of clinical questions assumed to be often shared by healthcare professionals. For clarity, we divided the contents of the guidelines into eight areas. In each area, clinical questions are presented, together with recommendations of clinical actions in response to the question. As mentioned already, there is a paucity of high-level evidence in this area; therefore, the recommendations are classified into grades, of which there are five: A, strongly recommend performing the clinical action; B, recommend performing the clinical action; C1, the clinical action may be useful, although there is a lack of high-level scientific evidence; C2, clinical action not definitively recommended because of insufficient scientific evidence; D, recommend not performing the clinical action. The grading of the recommendations is based on the determination of the level of evidence in references on which the recommendation is based. ( view less ) View Full Abstract View Article Details View Coded Data Related Articles Attitudes and perceptions of AIDS clinical trials group site coordinators on HIV clinical trial recruitment and retention: a descriptive study. Aug 2007 William D King,Donna Defreitas,Kimberly Smith,Janet Andersen,Lisa Patton Perry,Toyin Adeyemi,Jennifer Mitty,Jan Fritsche,Carrie Jeffries,Melvin Littles,Margaret Fischl,Gregory Pavlov,Donna Mildvan,Underrepresented Populations Committee of the Adult AIDS Clinical Trials Group (AACTG) HIV-seropositive blacks, Hispanics, women of all ethnicities, and injection drug users (IDUs) have low rates of clinical trial participation. The opinions of research nurses and study coordinators as potential facilitators and barriers to access to clinical trials may contribute to this disparity. ... ( view more )Study coordinators and research nurses from the adult AIDS Clinical Trials Group (ACTG) clinical trials units responded to an anonymous computer-based survey comprising multiple choice questions and clinical scenarios. Descriptive statistics were used to determine frequencies of responses. Recruitment rates of blacks, Hispanics, women and IDUs were mostly rated appropriate compared with the geographic region demographics. Most sites ranked white men as being the most interested in clinical trials. Sites rated their most effective interactions were with white men. Respondents felt they were less likely to enroll individuals who had missed previous clinical appointments or did not speak English. Perceptions that IDUs, Hispanics, blacks, and, to a lesser extent, women had less interest in clinical trials participation than white males may affect recruitment of the targeted populations. Interventions to improve interactions with targeted populations and to remove logistical and language barriers may improve the diversity of clinical trial participants. ( view less ) View Full Abstract View Article Details   Related Articles Contraceptive provision in genitourinary medicine clinics in the UK. Feb 2007 J R Willcox,M Huengsberg,Phillip Kell,British Co-Operative Clinical Group of British Association for Sexual Health and HIV ,Damitha Edirisinghe,Karen Rogstad,Gail Crowe,Anne Meik de Reuter,Sarah Edwards,Gurdeep Singh,Noreen Desmond,Deb Mandal,Raymond Maw,Alexander McMillan The objective of this study was to assess current and future contraceptive provision in genitourinary (GU) medicine clinics in the United Kingdom. Questionnaires were sent to 18 British Co-Operative Clinical Group regional representatives for distribution to clinical leads. Of 185 clinics, 124 (67%... ( view more )) responded. All clinics provided condoms, 116 (94%) the 'morning after' pill and 31 (25%) would fit an intrauterine contraceptive device (IUCD) for emergency contraception. Twenty-three (18.5%) regarded their clinic as already providing a comprehensive service and most of these could provide a wide range of contraceptive methods. Of all clinics, which included eight (34%) clinics already providing a comprehensive service, 69 (56%) anticipated developing their contraceptive provision within the next five years. In conclusion, contraceptive provision varies between clinics. A reduction in unwanted pregnancies and sexually transmitted infections (STIs) would most likely be achieved if clinics expanded their provision of contraceptive services. ( view less ) View Full Abstract View Article Details   Related Articles Estimating clinically significant differences in quality of life outcomes. Mar 2005 Kathleen W Wyrwich,Monika Bullinger,Neil Aaronson,Ron D Hays,Donald L Patrick,Tara Symonds,The Clinical Significance Consensus Meeting Group OBJECTIVE: This report extracts important considerations for determining and applying clinically significant differences in quality of life (QOL) measures from six published articles written by 30 international experts, in the field of QOL assessment and evaluation. The original six articles were p... ( view more )resented at the Symposium on Clinical Significance of Quality of Life Measures in Cancer Patients at the Mayo Clinic in April 2002 and subsequently were published in Mayo Clinic Proceedings. PRINCIPAL FINDINGS: Specific examples and formulas are given for anchor-based methods, as well as distribution-based methods that correspond to known or relevant anchors to determine important differences in QOL measures. Important prerequisites for clinical significance associated with instrument selection, responsiveness, and the reporting of QOL trial results are provided. We also discuss estimating the number needed to treat (NNT) relative to clinically significant thresholds. Finally, we provide a rationale for applying group-derived standards to individual assessments. CONCLUSIONS: While no single method for determining clinical significance is unilaterally endorsed, the investigation and full reporting of multiple methods for establishing clinically significant change levels for a QOL measure, and greater direct involvement of clinicians in clinical significance studies are strongly encouraged. ( view less ) View Full Abstract View Article Details View Coded Data Related Articles American Society of Clinical Oncology policy statement update: genetic testing for cancer susceptibility. Jun 15, 2003 American Society of Clinical Oncology 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, in... ( view more )to 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 the scope of parental authority encompasses the right to decide for or against testing. In the absence of increased risk of a childhood malignancy, ASCO recommends delaying genetic testing until an individual is of sufficient age to make an informed decision regarding such tests. As in other areas of pediatric care, the clinical cancer genetics professional should be an advocate for the best interests of the child. Counseling About Medical Management After Testing: ASCO recommends that oncologists include in pre- and post-test counseling the discussion of possible risks and benefits of cancer early-detection and prevention modalities, some of which have presumed but unproven efficacy for individuals at increased hereditary risk of cancer. Regulation of Genetic Testing: ASCO recommends strengthening regulatory oversight of laboratories that provide clinical cancer predisposition tests. These quality assurance mechanisms should include oversight of the reagents used in genetic testing, interlaboratory comparisons of reference samples, standardization of laboratory genetic test reports, and proficiency testing. Protection From Insurance and Employment Discrimination: ASCO supports establishing a federal law to prohibit discrimination by health insurance providers and employers on the basis of an individual's inherited susceptibility to cancer. Protections against genetic discrimination should apply to those with group coverage, those with individual health insurance policies, and the uninsured. Coverage of Services: ASCO supports efforts to ensure that all individuals at significantly increased risk of hereditary cancer have access to appropriate genetic counseling, testing, screening, surveillance, and all related medical and surgical interventions, which should be covered without penalty by public and private third-party payers. Confidentiality and Communication of Familial Risk: ASCO recommends that providers make concerted efforts to protect the confidentiality of genetic information. However, they should remind patients of the importance of communicating test results to family members, as part of pretest counseling and informed consent discussions. ASCO believes that the cancer care provider's obligations (if any) to at-risk relatives are best fulfilled by communication of familial risk to the person undergoing testing, emphasizing the importance of sharing this information with family members so that they may also benefit. Educational Opportunities in Genetics: ASCO is committed to continuing to provide educational opportunities for physicians and other health care providers regarding the methods of cancer risk assessment, the clinical characteristics of hereditary cancer susceptibility syndromes, and the range of issues related to genetic testing, including pre- and post-test genetic counseling, and risk management, so that health professionals may responsibly integrate the care of persons at increased genetic risk of cancer into the practice of clinical and preventive oncology. Special Issues Relating to Genetic Research on Human Tissues:ASCO recommends that all researchers proposing to use or store human biologic specimens for genetic studies should consult either the responsible institutional review board (IRB) or a comparable body specifically constituted to assess human tissue research, to determine the requirements for protection specific to the study under consideration. This consultation should take place before the project is initiated. The determination of the need for informed consent or authorization in such studies should depend on whether the research involves tests for genetic markers of known clinical significance and whether research data will be linked to protected health information, as well as other considerations specific to the study proposed. Special attention should also be paid to 1) whether future research findings will be disclosed to the research participants, 2) whether future contact of participants is planned, 3) whether and how protected health information about the tissue donors will be stored, and what will happen to study specimens after the trial ends. In addition, ASCO affirms the right of people contributing tissue to a databank to rescind their permission, in accordance with federal privacy regulations. ( view less ) View Full Abstract View Article Details View Coded Data Related Articles Patient satisfaction and quality of care in walk-in clinics, family practices and emergency departments: the Ontario Walk-In Clinic Study. Apr 15, 2003 Brian Hutchison,Truls Østbye,Jan Barnsley,Moira Stewart,Maria Mathews,M Karen Campbell,Eugene Vayda,Stewart B Harris,Vicki Torrance-Rynard,Christine Tyrrell,Ontario Walk-In Clinic Study BACKGROUND: Although walk-in clinics are an increasingly common feature of Ontario's health care system, the quality of care they provide is the subject of continuing debate. In this study we examined differences in patient satisfaction and quality of care for common acute conditions in walk-in cli... ( view more )nics, family practices and emergency departments. METHODS: For this prospective cohort study, we recruited 12 walk-in clinics, 16 family practices and 13 emergency departments from 11 geographic areas in greater Toronto, Hamilton-Burlington and London, Ont. An expert review panel selected and established quality-of-care criteria for 8 common acute conditions. Patients who sought initial care for 1 of the 8 conditions were recruited by an on-site data collector. We used a questionnaire to assess the satisfaction of 433 patients with patient-centred communication, the physician's attitude and any delay in the waiting room during the study visit. Abstractors reviewed 600 charts for the study patients to assess whether the quality-of-care criteria had been met. A quality score for each case was computed as the percentage of applicable criteria that were met. Mean quality scores for the 3 settings were computed, with adjustment for potentially confounding variables (sex, age, city and diagnosis). RESULTS: After adjustment for 12 patient characteristics, walk-in clinic patients were significantly more satisfied than emergency department patients on all 3 satisfaction scales. Family practice patients were more satisfied than walk-in clinic patients on all 3 satisfaction scales, but the difference was statistically significant only for satisfaction with waiting time. Adjusted mean quality-of-care scores were 73.1% for emergency departments, 69.9% for walk-in clinics and 64.1% for family practices. The scores for walk-in clinics and emergency departments were significantly higher than that for family practices. INTERPRETATION: Satisfaction with waiting time was highest among family practice patients. Both family practices and walk-in clinics were perceived more positively than emergency departments on all 3 dimensions of satisfaction. Overall quality-of-care scores were higher in walk-in clinics and emergency departments than in family practices. ( view less ) View Full Abstract View Article Details View Coded Data Related Articles National academy of clinical biochemistry laboratory medicine practice guidelines: recommendations for the use of laboratory tests to support poisoned patients who present to the emergency department. Mar 2003 Alan H B Wu,Charles McKay,Larry A Broussard,Robert S Hoffman,Tai C Kwong,Thomas P Moyer,Edward M Otten,Shirley L Welch,Paul Wax,National Academy of Clinical Biochemistry Laboratory Medicine BACKGROUND: Exposure to drugs and toxins is a major cause for patients' visits to the emergency department (ED). METHODS: Recommendations for the use of clinical laboratory tests were prepared by an expert panel of analytical toxicologists and ED physicians specializing in clinical toxicology. Thes... ( view more )e recommendations were posted on the world wide web and presented in open forum at several clinical chemistry and clinical toxicology meetings. RESULTS: A menu of important stat serum and urine toxicology tests was prepared for clinical laboratories who provide clinical toxicology services. For drugs-of-abuse intoxication, most ED physicians do not rely on results of urine drug testing for emergent management decisions. This is in part because immunoassays, although rapid, have limitations in sensitivity and specificity and chromatographic assays, which are more definitive, are more labor-intensive. Ethyl alcohol is widely tested in the ED, and breath testing is a convenient procedure. Determinations made within the ED, however, require oversight by the clinical laboratory. Testing for toxic alcohols is needed, but rapid commercial assays are not available. The laboratory must provide stat assays for acetaminophen, salicylates, co-oximetry, cholinesterase, iron, and some therapeutic drugs, such as lithium and digoxin. Exposure to other heavy metals requires laboratory support for specimen collection but not for emergent testing. CONCLUSIONS:Improvements are needed for immunoassays, particularly for amphetamines, benzodiazepines, opioids, and tricyclic antidepressants. Assays for new drugs of abuse must also be developed to meet changing abuse patterns. As no clinical laboratory can provide services to meet all needs, the National Academy of Clinical Biochemistry Committee recommends establishment of regional centers for specialized toxicology testing. ( view less ) View Full Abstract View Article Details View Coded Data Related Articles Use of epoetin in patients with cancer: evidence-based clinical practice guidelines of the American Society of Clinical Oncology and the American Society of Hematology. Oct 1, 2002 J Douglas Rizzo,Alan E Lichtin,Steven H Woolf,Jerome Seidenfeld,Charles L Bennett,David Cella,Benjamin Djulbegovic,Matthew J Goode,Ann A Jakubowski,Stephanie J Lee,Carole B Miller,Mark U Rarick,David H Regan,George P Browman,Michael S Gordon,American Society of Clinical Oncology. American Society of Hematology Anemia resulting from cancer, or its treatment, is an important clinical problem increasingly treated with the recombinant hematopoietic growth factor erythropoietin. To address uncertainties regarding indications and efficacy, the American Society of Clinical Oncology and the American Society of H... ( view more )ematology developed an evidence-based clinical practice guideline for the use of epoetin in patients with cancer. The guideline panel found good evidence to recommend use of epoetin as a treatment option for patients with chemotherapy-associated anemia with a hemoglobin level less than 10 g/dL. Use of epoetin for patients with less severe anemia (hemoglobin < 12 g/dL but never below 10 g/dL) should be determined by clinical circumstances. Good evidence from clinical trials supports the use of subcutaneous epoetin thrice weekly (150 U/kg tiw) for a minimum of 4 weeks. Less strong evidence supports an alternative weekly (40,000 U/wk) dosing regimen, based on common clinical practice. With either administration schedule, dose escalation should be considered for those not responding to the initial dose. In the absence of response, continuing epoetin beyond 6 to 8 weeks does not appear to be beneficial. Epoetin should be titrated once the hemoglobin concentration reaches 12 g/dL. Evidence from one randomized controlled trial supports use of epoetin for patients with anemia associated with low-risk myelodysplasia not receiving chemotherapy; however, there are no published high-quality studies to support its use for anemia in other hematologic malignancies in the absence of chemotherapy. Therefore, for anemic patients with hematologic malignancies, it is recommended that physicians initiate conventional therapy and observe hematologic response before considering use of epoetin. ( view less ) View Full Abstract View Article Details View Coded Data Related Articles The clinical significance of quality-of-life results: practical considerations for specific audiences. Jun 2002 Tara Symonds,Rick Berzon,Patrick Marquis,Teresa A Rummans,Clinical Significance Consensus Meeting Group This is the sixth article in a series intended to summarize the state of the science for assessing the clinical significance of quality-of-life (QOL) assessments. The previous 5 articles dealt with specific methodological issues, whereas this article addresses practical considerations in implementi... ( view more )ng the methods and presenting the results to various audiences with differing perspectives. Proposals for how to interpret the "clinical significance" or "clinical meaningfulness" of changes in QOL scores were addressed in previous articles within this series. Within this article, 4 audiences-patients and physicians, clinical researchers, health policymakers, and private- and public-sector employees who work in health-related fields-are examined because each is a unique stakeholder with a distinct vantage point and each can interpret QOL outcomes differently. A clinician may attempt to explain to a patient potential treatment alternatives for his or her QOL; a health policymaker may try to describe to elected officials the financial impact on a patient population with reduced QOL; a researcher may try to obtain the vital messages from a clinical trial that included QOL end points; and a regulatory agency and/or pharmaceutical company may try to ascertain the appropriate level of evidence required for a successful research study. For each of the 4 audiences, concrete examples and practical guidelines are offered by which changes in QOL outcomes can be interpreted meaningfully. Ultimately, both determining and disseminating the meaning of clinical significance are functions of the outlook of the audience because the perspective of the audience determines its ability to comprehend, evaluate, and convey the context within which such outcomes appear meaningful. Among the audiences described within this article, a commonality of interests exist that mandates a careful exposition of the scientific rigor involved in describing the clinical significance of QOL assessments. Collectively, this series attempts to provide methods and means for making such determinations. ( view less ) View Full Abstract View Article Details View Coded Data Related Articles Patient satisfaction and quality of care in walk-in clinics, family practices and emergency departments: the Ontario Walk-In Clinic Study 2003 B. Hutchison, T. Ostbye, J. Barnsley, M. Stewart, M. Mathews, M. K. Campbell, E. Vayda, S. B. Harris, V. Torrance-Rynard, C. Tyrrell and S. Ontario Walk-In Clinic BACKGROUND: Although walk-in clinics are an increasingly common feature of Ontario's health care system, the quality of care they provide is the subject of continuing debate. In this study we examined differences in patient satisfaction and quality of care for common acute conditions in walk-in cl... ( view more )inics, family practices and emergency departments. METHODS: For this prospective cohort study, we recruited 12 walk-in clinics, 16 family practices and 13 emergency departments from 11 geographic areas in greater Toronto, Hamilton-Burlington and London, Ont. An expert review panel selected and established quality-of-care criteria for 8 common acute conditions. Patients who sought initial care for 1 of the 8 conditions were recruited by an on-site data collector. We used a questionnaire to assess the satisfaction of 433 patients with patient-centred communication, the physician's attitude and any delay in the waiting room during the study visit. Abstractors reviewed 600 charts for the study patients to assess whether the quality-of-care criteria had been met. A quality score for each case was computed as the percentage of applicable criteria that were met. Mean quality scores for the 3 settings were computed, with adjustment for potentially confounding variables (sex, age, city and diagnosis). RESULTS: After adjustment for 12 patient characteristics, walk-in clinic patients were significantly more satisfied than emergency department patients on all 3 satisfaction scales. Family practice patients were more satisfied than walk-in clinic patients on all 3 satisfaction scales, but the difference was statistically significant only for satisfaction with waiting time. Adjusted mean quality-of-care scores were 73.1% for emergency departments, 69.9% for walk-in clinics and 64.1% for family practices. The scores for walk-in clinics and emergency departments were significantly higher than that for family practices. INTERPRETATION: Satisfaction with waiting time was highest among family practice patients. Both family practices and walk-in clinics were perceived more positively than emergency departments on all 3 dimensions of satisfaction. Overall quality-of-care scores were higher in walk-in clinics and emergency departments than in family practices. ( view less ) View Full Abstract View Article Details   Related Articles Patient satisfaction and quality of care in walk-in clinics, family practices and emergency departments: the Ontario Walk-In Clinic Study.[see comment] 4-15-2003 Hutchison, B., Ostbye, T., Barnsley, J., Stewart, M., Mathews, M., Campbell, M. K., Vayda, E., Harris, S. B., Torrance-Rynard, V., Tyrrell, C., and Ontario Walk-In Clinic Study BACKGROUND: Although walk-in clinics are an increasingly common feature of Ontario's health care system, the quality of care they provide is the subject of continuing debate. In this study we examined differences in patient satisfaction and quality of care for common acute conditions in walk-in cli... ( view more )nics, family practices and emergency departments. METHODS: For this prospective cohort study, we recruited 12 walk-in clinics, 16 family practices and 13 emergency departments from 11 geographic areas in greater Toronto, Hamilton-Burlington and London, Ont. An expert review panel selected and established quality-of-care criteria for 8 common acute conditions. Patients who sought initial care for 1 of the 8 conditions were recruited by an on-site data collector. We used a questionnaire to assess the satisfaction of 433 patients with patient-centred communication, the physician's attitude and any delay in the waiting room during the study visit. Abstractors reviewed 600 charts for the study patients to assess whether the quality-of-care criteria had been met. A quality score for each case was computed as the percentage of applicable criteria that were met. Mean quality scores for the 3 settings were computed, with adjustment for potentially confounding variables (sex, age, city and diagnosis). RESULTS: After adjustment for 12 patient characteristics, walk-in clinic patients were significantly more satisfied than emergency department patients on all 3 satisfaction scales. Family practice patients were more satisfied than walk-in clinic patients on all 3 satisfaction scales, but the difference was statistically significant only for satisfaction with waiting time. Adjusted mean quality-of-care scores were 73.1% for emergency departments, 69.9% for walk-in clinics and 64.1% for family practices. The scores for walk-in clinics and emergency departments were significantly higher than that for family practices. INTERPRETATION: Satisfaction with waiting time was highest among family practice patients. Both family practices and walk-in clinics were perceived more positively than emergency departments on all 3 dimensions of satisfaction. Overall quality-of-care scores were higher in walk-in clinics and emergency departments than in family practices ( view less ) View Full Abstract View Article Details View Coded Data Related Articles Clinical cure of bacterial conjunctivitis with azithromycin 1%: vehicle-controlled, double-masked clinical trial. Jun 2008 Mark B Abelson,Warren Heller,Aron M Shapiro,Erwin Si,Peng Hsu,Lyle M Bowman,AzaSite Clinical Study Group PURPOSE: To analyze the effect of azithromycin 1% ophthalmic solution in DuraSite (InSite Vision, Inc, Alameda, California, USA) on bacterial conjunctivitis. DESIGN: Prospective, randomized, vehicle-controlled, parallel-group, double-masked multicenter clinical study. METHODS: Eligible male or fema... ( view more )le participants with a clinical diagnosis of acute bacterial conjunctivitis were randomized to either 1% azithromycin in DuraSite or vehicle for five days. Infected eyes were dosed twice daily on days 1 and 2 and once daily on days 3 through 5. Conjunctival cultures were obtained at baseline, visit 2 (day 3 or 4), and visit 3 (day 6 or 7). The primary end point was clinical resolution of signs and symptoms (rating of zero on ocular discharge, bulbar and palpebral injection) at visit 3. Efficacy measures were clinical resolution and bacterial eradication as evaluated in the per-protocol population. Safety was assessed by adverse events, slit-lamp findings, and ophthalmoscopy. RESULTS: Two hundred and seventy-nine participants (n = 130, 1% azithromycin in DuraSite; n = 149, vehicle), age one to 96 years, were evaluated for efficacy. Clinical resolution with azithromycin ophthalmic solution was statistically significant compared with that of vehicle (P = .030) at visit 3. Bacterial eradication rates with azithromycin ophthalmic solution reached 88.5% at visit 3 (P < .001) and included some pathogens resistant to azithromycin in vitro. Overall, adverse event rates were similar in both treatment groups. CONCLUSIONS: Azithromycin 1% ophthalmic solution in DuraSite showed statistically significant differences in clinical resolution and bacterial eradication rates when compared with vehicle. Because it was well tolerated in this population, it may be a viable treatment option for children and adults with bacterial conjunctivitis. ( view less ) View Full Abstract View Article Details View Coded Data Related Articles Design and endpoints of clinical trials in hepatocellular carcinoma. May 21, 2008 Josep M Llovet,Adrian M Di Bisceglie,Jordi Bruix,Barnett S Kramer,Riccardo Lencioni,Andrew X Zhu,Morris Sherman,Myron Schwartz,Michael Lotze,Jayant Talwalkar,Gregory J Gores,Panel of Experts in HCC-Design Clinical Trials The design of clinical trials in hepatocellular carcinoma (HCC) is complex because many patients have concurrent liver disease, which can confound the assessment of clinical benefit. There is an urgent need for high-quality trials in this disease. An expert panel was convened by the American Associ... ( view more )ation for the Study of Liver Diseases to develop guidelines that provide a common framework for designing trials to facilitate comparability of results. According to these guidelines, randomized phase 2 trials with a time-to-event primary endpoint, such as time to progression, are pivotal in clinical research on HCC. Survival remains the main endpoint to measure effectiveness in phase 3 studies, whereas time to recurrence is proposed as an appropriate endpoint in the adjuvant setting. Because progression-free survival and disease-free survival are composite endpoints, they are more vulnerable than others in HCC clinical studies and may not be able to capture clinical benefits. Selection of the target population should be based on the Barcelona Clinic Liver Cancer staging system. New drugs should be tested in patients with well-preserved liver function (Child-Pugh A class). Patients assigned to the control arm should receive standard-of-care therapy, that is, chemoembolization for patients with intermediate-stage disease and sorafenib for patients with advanced-stage disease. Further research is needed to incorporate biomarkers and molecular imaging into clinical research in HCC. These surrogate markers may help to enrich study populations and maximize the cost-benefit ratio of trial execution. Design and conduct of phase 3 trials should be coordinated by centers with appropriate expertise in HCC. ( view less ) View Full Abstract View Article Details View Coded Data Related Articles Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. Mar 1, 2008 Howard I Scher,Susan Halabi,Ian Tannock,Michael Morris,Cora N Sternberg,Michael A Carducci,Mario A Eisenberger,Celestia Higano,Glenn J Bubley,Robert Dreicer,Daniel Petrylak,Philip Kantoff,Ethan Basch,William Kevin Kelly,William D Figg,Eric J Small,Tomasz M Beer,George Wilding,Alison Martin,Maha Hussain,Prostate Cancer Clinical Trials Working Group PURPOSE: To update eligibility and outcome measures in trials that evaluate systemic treatment for patients with progressive prostate cancer and castrate levels of testosterone. METHODS: A committee of investigators experienced in conducting trials for prostate cancer defined new consensus criteria... ( view more ) by reviewing previous criteria, Response Evaluation Criteria in Solid Tumors (RECIST), and emerging trial data. RESULTS: The Prostate Cancer Clinical Trials Working Group (PCWG2) recommends a two-objective paradigm: (1) controlling, relieving, or eliminating disease manifestations that are present when treatment is initiated and (2) preventing or delaying disease manifestations expected to occur. Prostate cancers progressing despite castrate levels of testosterone are considered castration resistant and not hormone refractory. Eligibility is defined using standard disease assessments to authenticate disease progression, prior treatment, distinct clinical subtypes, and predictive models. Outcomes are reported independently for prostate-specific antigen (PSA), imaging, and clinical measures, avoiding grouped categorizations such as complete or partial response. In most trials, early changes in PSA and/or pain are not acted on without other evidence of disease progression, and treatment should be continued for at least 12 weeks to ensure adequate drug exposure. Bone scans are reported as "new lesions" or "no new lesions," changes in soft-tissue disease assessed by RECIST, and pain using validated scales. Defining eligibility for prevent/delay end points requires attention to estimated event frequency and/or random assignment to a control group. CONCLUSION: PCWG2 recommends increasing emphasis on time-to-event end points (ie, failure to progress) as decision aids in proceeding from phase II to phase III trials. Recommendations will evolve as data are generated on the utility of intermediate end points to predict clinical benefit. ( view less ) View Full Abstract View Article Details View Coded Data Related Articles Clinical cancer advances 2006: major research advances in cancer treatment, prevention, and screening--a report from the American Society of Clinical Oncology. Jan 1, 2007 Robert F Ozols,Roy S Herbst,Yolonda L Colson,Julie Gralow,James Bonner,Walter J Curran,Burton L Eisenberg,Patricia A Ganz,Barnett S Kramer,Mark G Kris,Maurie Markman,Robert J Mayer,Derek Raghavan,Gregory H Reaman,Raymond Sawaya,Richard L Schilsky,Lynn M Schuchter,John W Sweetenham,Linda T Vahdat,Rodger J Winn,American Society of Clinical Oncology 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 pub... ( view more )lished 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 waiting to be "translated" into useful therapies and diagnostics. In addition to highlighting the major research advances over the past year, this report also identifies key barriers to accelerating the pace of cancer research and outlines ASCO's recommendations for overcoming them. Despite these and other challenges, there is much good news on the front lines of cancer research. This report demonstrates the essential role of clinical cancer research in finding new and better ways to treat, diagnose, and prevent a group of diseases that strike half of men and one-third of women in the United States. ( view less ) View Full Abstract View Article Details   Related Articles Guidelines for resident training in veterinary clinical pathology. II. Hematology. Dec 2006 Leslie Sharkey,Maxey Wellman,Mary M Christopher,American Society for Veterinary Clinical Pathology Education Committee BACKGROUND: The Education Committee of the American Society for Veterinary Clinical Pathology (ASVCP) identified a need for improved structure and guidance in training residents in clinical pathology. To begin to meet this need, guidelines for training in clinical chemistry were published in 2003. ... ( view more )OBJECTIVE: The goal of this report is to define learning objectives and competencies in hematology, including coagulation and immunohematology. METHODS: These guidelines were developed and written with the input of ASVCP Education Committee members and peer experts. RESULTS: The primary objectives of training in hematology are: 1) to accrue a thorough, extensive, and relevant knowledge base of the types, principles, and properties of hematology tests and concepts of pathophysiology in animals; 2) to develop abilities to reason, think critically, communicate effectively, and exercise judgment in hematologic data interpretation and investigative problem-solving; and 3) to acquire technical and statistical skills important in hematology and laboratory operations. We also provide options and ideas for training activities and identify hematology resources useful for clinical pathology faculty and staff, training program coordinators, and residents. CONCLUSIONS: The guidelines define expected competencies that will help ensure proficiency, leadership, and the advancement of knowledge in veterinary hematology and provide a useful framework for didactic and clinical activities in resident-training programs. The learning objectives can readily be adapted to institutional and individual needs, interests, goals, and resources. ( view less ) View Full Abstract View Article Details   Related Articles American Society of Clinical Oncology clinical practice guideline for the use of larynx-preservation strategies in the treatment of laryngeal cancer. Aug 1, 2006 American Society of Clinical Oncology ,David G Pfister,Scott A Laurie,Gregory S Weinstein,William M Mendenhall,David J Adelstein,K Kian Ang,Gary L Clayman,Susan G Fisher,Arlene A Forastiere,Louis B Harrison,Jean-Louis Lefebvre,Nancy Leupold,Marcy A List,Bernard O O'Malley,Snehal Patel,Marshall R Posner,Michael A Schwartz,Gregory T Wolf PURPOSE: 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. METHODS: A multidisciplinary ... ( view more )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. RESULTS: 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. RECOMMENDATIONS: 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. ( view less ) View Full Abstract View Article Details View Coded Data Related Articles Clinical Cancer Advances 2005: major research advances in cancer treatment, prevention, and screening--a report from the American Society of Clinical Oncology. Jan 1, 2006 Roy S Herbst,Dean F Bajorin,Harry Bleiberg,Diane Blum,Desirée Hao,Bruce E Johnson,Robert F Ozols,George D Demetri,Patricia A Ganz,Mark G Kris,Bernard Levin,Maurie Markman,Derek Raghavan,Gregory H Reaman,Raymond Sawaya,Lynn M Schuchter,John W Sweetenham,Linda T Vahdat,Everett E Vokes,Rodger J Winn,Robert J Mayer,American Society of Clinical Oncology 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 a... ( view more )cross 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 lives of so many. I want to thank the Editorial Board members, the Specialty Editors, and the ASCO Cancer Communications Committee for their dedicated work to develop this report, and I hope you find it useful. ( view less ) View Full Abstract View Article Details View Coded Data Related Articles Page 1 of 51 1 2 3 4 > Last >> (1270 articles found)

      
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