PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “Consensus Statements as Topic”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 397 records · Page 22Linked to original sources
PubMed2005

A concept for the clinical implementation of sentinel lymph node biopsy in patients with breast carcinoma with special regard to quality assurance.

The development of standardized and reproducible clinical pathways is an important precondition for quality assurance in medicine, especially if a new method has not yet been ultimately validated. Sentinel lymph node biopsy (SLNB) is a widely accepted new surgical procedure in the treatment of early breast carcinoma. However, numerous steps of the method and details of the technique are not standardized and, thus, hamper quality assurance for SLNB. The German Society of Senology appointed an interdisciplinary consensus committee to work out guidelines for the standardized performance and quality-assured implementation of SLNB on a nationwide, homogeneous standard. The committee consisted of surgeons, gynecologists, radiooncologists, nuclear physicians, oncologists, and pathologists. Relevant questions related to patient selection, lymphatic mapping, surgery, histopathologic work-up, further local and systemic treatment decisions, patient information, training, and follow-up were evaluated with respect to clinical evidence, objectivity, and reproducibility. Clinical pathways were developed on the basis of this analysis. Requirements to the performing institutions and surgeons were defined.

Breast Neoplasms↗
PubMed1997

Therapy of hepatitis C: alpha interferon and ribavirin.

Ribavirin is a nucleoside analogue that has been evaluated as a therapy of chronic hepatitis C alone and in combination with alpha interferon. Ribavirin is well absorbed orally and is typically given in doses of 1,000 to 1,200 mg/d. Three randomized, placebo-controlled studies comprising more than 150 patients have shown that therapy with ribavirin alone for 24 to 48 weeks resulted in a significant reduction in serum alanine aminotransferase (ALT) levels during therapy. However, ribavirin therapy did not lead to a substantial reduction in hepatitis C virus (HCV) RNA levels; almost all patients remained viremic, and serum aminotransferase levels increased to pretreatment values when therapy was stopped. The most common adverse event was a moderate and reversible hemolysis during treatment that caused a decrease in hemoglobin by 10% to 20% of baseline levels. Combination therapy of ribavirin with alpha interferon has demonstrated promise both in pilot studies and a recently completed randomized controlled trial. Ribavirin in standard doses combined with alpha interferon in doses of 3 million units (MU) three times weekly for 6 months was found to significantly improve the sustained biochemical and virological response rates compared with interferon alone. Combination therapy offers a promise to become standard therapy for patients with nonsustained response to alpha interferon alone, because the majority of such patients achieve a durable response after treatment with combination therapy. However, nonresponders to alpha interferon alone rarely achieve a sustained beneficial response to combination treatment. For interferon-naive patients, combination therapy is superior to therapy with alpha interferon alone in achieving sustained biochemical and virological responses, but the combination demonstrates clear-cut superiority only in patients with unfavorable profiles for a response to interferon, in particular patients with high levels of HCV RNA. The optimal use and regimen of combination therapy awaits further investigation. New antiviral agents are still needed for the proportion of patients who do not respond to alpha interferon, even in combination with ribavirin.

Antiviral Agents↗
PubMedDate not supplied

The development of clinical practice guidelines for treatment of peptic acid diseases in a VA ambulatory care clinic.

The costly treatment of peptic acid diseases at a Veterans Affairs ambulatory care clinic prompted the development of clinical practice guidelines (CPGs) for the disorders. A committee consisting of a clinical pharmacist, the chiefs of ambulatory care and medicine, and a gastroenterologist guided the process. A consensus-style conference format involving medical staff and residents, pharmacists, and other health providers was chosen to develop the CPGs. Before the conference each participant received a list of key issues and literature on practice guidelines, and on peptic acid diseases and their treatment. At the conference the participants were divided into four groups; each group discussed specific key issues using a modified nominal group process. Recommendations from each group were made to the entire conference. Final recommendations were compiled into what was adopted and readily received as the CPGs for the institution.

Algorithms↗
PubMed1991

The risky shift.

Explore the source record for details and available documents.

Biometry↗
PubMed2005

Managing the risks of therapeutic products: proceedings of a workshop.

Traditional tools available to the Food and Drug Administration for managing known risks of therapeutic products (drugs, devices and biological products) have limited effectiveness. This report presents the recommendations of a multidisciplinary workshop focused on managing these risks. This is the last in a series of five workshops coordinated by the Centers for Education and Research on Therapeutics (CERTs) on assessing, communicating and managing the risks and benefits of therapeutic products. Workshop participants included experts from government, academia, industry and healthcare organizations, including consumers. Using a modified nominal group process, participants developed a consensus on principles that should govern future risk management (RM) programs, specifically: in order to protect the public health, risk management programs (RMPs) should be evidence-based, science-driven and patient-focused. A plan to manage the risks of each new therapeutic product should be developed prior to its approval. Evaluation of both the processes and outcomes of RM is essential; these evaluations should be in the public domain. Participants also identified and prioritized research and policy gaps related to RM. Recommended research areas included determining the effectiveness of each element of RMPs, finding the best ways to inform healthcare consumers and determining the best way to present risk information in drug labeling. Policy questions included defining the criteria for requiring a RMP, determining the effect of privacy legislation on RMPs and determining how the continuum of risk across therapeutic products should be classified. As this workshop demonstrated, it is possible to develop a prioritized research and policy agenda to meet the needs of all constituencies. Collaboration across diverse government, academic, industry and constituency-based organizations can lead to solutions for the perplexing problems involved in balancing the risks and benefits of therapeutic products. Patients deserve no less as we strive to protect their safety.

Consensus Statements as Topic↗
PubMed2003

Risk assessment of drugs, biologics and therapeutic devices: present and future issues.

PURPOSE: The current US system for detecting adverse effects of therapeutics (drugs, devices and biological products) is suboptimal. This report presents the results of an expert workshop on assessing therapeutic risks. This is the second of five workshops coordinated by the Centers for Education and Research on Therapeutics (CERTs) to address the management of therapeutic risks relative to potential benefits. METHODS: The workshop included academic, industry, government and constituency-based leaders. The focus was on the post-approval phase and procedures in the US, but relevant international issues and attendees were included. RESULTS: Substantial deficiencies in the current US system for risk assessment were delineated. Improving the system will involve research into methods to improve risk assessment, enhancement and consolidation of data-handling systems, education of healthcare workers, allocation of financial resources and building of constituencies. CONCLUSIONS: We need leadership on multiple levels for global coordination of risk assessment. We can then begin to fill gaps and produce benefits for industry, health authorities, government agencies, healthcare providers, and most important, the public.

Adverse Drug Reaction Reporting Systems↗
PubMed1997

Medical treatment of heart failure: the Canadian Cardiovascular Society's Consensus Conference revisited.

The report of the Canadian Cardiovascular Society's Consensus Conference on the diagnosis and management of heart failure was published in 1994. Focusing on the chronic medical treatment of patients with systolic left ventricular dysfunction, we summarize and update the consensus recommendations in the light of the results of several more recent studies. While the positive treatment recommendations are still fully valid or even reinforced by these new data, a somewhat more liberal use of beta-blockers, amiodarone, and newer calcium channel blockers seems justified.

Adrenergic beta-Antagonists↗
PubMed1989

Lipids, lipoproteins, and coronary heart disease: implications for antihypertensive therapy.

There is now considerable evidence that treatment of abnormalities of lipids and lipoproteins reduces the incidence of coronary heart disease (CHD). Treatment of hypertension, another major cardiovascular risk factor, has not been shown to have the same impact on CHD. Possible explanations for this are that cardiovascular risk factors may occur in combination in an individual or that therapy for hypertension has adversely affected one or several of the other risk factors for CHD, thereby offsetting the benefit gained by lowering blood pressure. This article reviews the relationship between lipids, lipoproteins, and coronary heart disease, and the impact of cholesterol lowering on CHD. The evidence that antihypertensive drugs are associated with lipid and lipoprotein abnormalities is introduced by a critical appraisal of the several studies for such evidence. Implications for the treatment of the hypertensive patient are discussed.

Antihypertensive Agents↗
PubMed1997

[Development of guidelines in radiation oncology].

BACKGROUND: On a national and international level many scientific and health political efforts are undertaken to develop specific guidelines for various medical disciplines. They are thought to improve the transparency of the medical health system and guarantee an improvement and special care for the individual patients. Besides other medical disciplines radiation oncology also has to develop and establish such guidelines. METHODS: After a specific definition of the different terms "standard", "guidelines" and "recommendation" a general description of the principle process involved in the development of guidelines is given. Furthermore, the current activities of the special working group "Quality Control in Radiation Oncology" of the German Radiation Oncology Society are elaborated. RESULTS: A detailed set of guidelines is expected to be completed by the end of 1997.

Consensus Statements as Topic↗