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Results for “Consensus Development Conferences, NIH as Topic”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

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At least 19 recordsLinked to original sources
PubMed1997

Overview of clinical trials on endosseous implants.

Early history of clinical trials on endosseous implants revolved around anecdotal reports on predominantly blade implants in the U.S. The first criteria to define success or failure were established at the National Institutes of Health (NIH)-Harvard Conference in 1978. This was followed by the multi-center trials from the Branemark group which described round, metallic implants. At the 1988 NIH Conference, questions dealt with the following: 1) the effectiveness of dental implants for the long-term; 2) indications and contra-indications of various types of implants; 3) requirements for management of dental implants; 4) health risks of dental implants; and 5) future directions in research. In the ensuing 7 years since the second NIH Conference, most of the data generated have been from non-controlled case reports, which describe a 90% success rate in 5 years or more with many types of endosteal systems in both partially and fully edentulous patients. Therefore, it can be said that there is evidence that dental implants are effective for the long-term. The other questions posed at the 1988 NIH Conference have not been as well described and have led to many controversies and future research areas. Two areas which will have a special future impact are 1) the establishment of a standard of care and risk-benefit ratio for implants and 2) the use of various factors to accelerate bone formation to allow greater access to dental implants by patients.

Bone Regeneration↗
PubMed2004

Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS).

Since the 1990 NIH-sponsored conference on polycystic ovary syndrome (PCOS), it has become appreciated that the syndrome encompasses a broader spectrum of signs and symptoms of ovarian dysfunction than those defined by the original diagnostic criteria. The 2003 Rotterdam consensus workshop concluded that PCOS is a syndrome of ovarian dysfunction along with the cardinal features hyperandrogenism and polycystic ovary (PCO) morphology. PCOS remains a syndrome and, as such, no single diagnostic criterion (such as hyperandrogenism or PCO) is sufficient for clinical diagnosis. Its clinical manifestations may include: menstrual irregularities, signs of androgen excess, and obesity. Insulin resistance and elevated serum LH levels are also common features in PCOS. PCOS is associated with an increased risk of type 2 diabetes and cardiovascular events.

Clinical Trials as Topic↗
PubMed1999

Surgical considerations for invasive breast cancer.

The 1992 NIH Consensus Development Conference reported that "breast conservation treatment is an appropriate method of primary therapy for the majority of women with stage I and II breast cancer and is preferable because it provides survival equivalent to total mastectomy and axillary dissection while preserving the breast." This conclusion has been solidly confirmed by recent updates of all of the prospective clinical trials performed. The uneven utilization of this BCS indicates the personal discomfort of some surgeons in recommending it or in communicating their recommendations to patients. The appropriate candidate for mastectomy is the patient in whom it is evident that BCS will not control the tumor. This conclusion may be drawn after one or even two attempts at revision have shown more extensive microscopic disease. The experience with preoperative chemotherapy programs such as NSABP Protocol B-18 shows that even for larger tumors primary excision or excision after preoperative chemotherapy provides reasonable rates of local control with no evidence of diminished distant control or survival. Very large tumors, often accompanied by other grave signs, are best treated by primary chemotherapy, because they are essentially not stage I or stage II disease. Although recognizing that better long-term cure rates are a function of the treatment of micrometastases with adjuvant chemotherapy, surgeons should remember the need to balance cosmetic factors with techniques required for good local control. Cosmetic factors are always important, but the primary concern is adequate removal of the primary tumor with pathologically negative margins. The best way to prevent the need for a salvage mastectomy following local recurrence is to obtain adequate control at the initial procedure, but this does not mean that aggressive local surgery is needed, and it certainly does not mean that a primary mastectomy is needed except in unusual cases.

Attitude of Health Personnel↗
PubMed2006

Alimentary tract mucositis in cancer patients: impact of terminology and assessment on research and clinical practice.

BACKGROUND AND SIGNIFICANCE: The field of terminology and assessment of oral and gastrointestinal mucosal injury caused by high-dose cancer therapies in cancer patients has undergone important evolution in recent years. The advances are important for several clinical and research reasons. These reasons include improved patient management and design and conduct of clinical trials based on molecularly targeted therapies. For several decades leading up to the 1980s, terminology was characterized by varying use of "mucositis" and "stomatitis" to describe oral mucosal inflammatory changes and ulceration caused by cancer treatments. In addition, oral mucositis was viewed principally as an epithelial event and one that likely did not intersect with causative mechanisms associated with gastrointestinal mucositis. The term "stomatitis" was directed to oral toxicities and seemed to isolate these conditions from parallel events occurring throughout the alimentary tract and potentially other tissues as well. These perspectives and varying use of these terms resulted in several dilemmas, including (1) difficulty in accurately reporting incidence and severity of oral mucositis and, (2) an under-appreciation of potential significance of alimentary tract mucosal toxicity relative to overall course of therapy, patient quality of life, and in some cases, survivorship. These and related components of the model relative to mucositis have undergone strategic shifts over the past 15 years. A 1989 National Institutes of Health Consensus Development Conference targeted oral mucositis research as one of the key areas for investigation relative to causation, clinical impact, and potential links with other complications in cancer patients. Research in this area over the past 15 years has evolved such that oral and gastrointestinal mucositis are now appropriately framed as a continuum of pathobiologic changes over time, with clinical impact that may well contribute to overall symptom clustering in selected patient cohorts. OBJECTIVES: This paper will review history, current status, and new research directions associated with terminology and assessment of mucosal injury in cancer patients in the context described above.

Bibliometrics↗
PubMed2005

National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report.

This consensus document is intended to serve 3 functions. First, it standardizes the criteria for diagnosis of chronic graft-versus-host disease (GVHD). Second, it proposes a new clinical scoring system (0-3) that describes the extent and severity of chronic GVHD for each organ or site at any given time, taking functional impact into account. Third, it proposes new guidelines for global assessment of chronic GVHD severity that are based on the number of organs or sites involved and the degree of involvement in affected organs (mild, moderate, or severe). Diagnosis of chronic GVHD requires the presence of at least 1 diagnostic clinical sign of chronic GVHD (e.g., poikiloderma or esophageal web) or the presence of at least 1 distinctive manifestation (e.g., keratoconjunctivitis sicca) confirmed by pertinent biopsy or other relevant tests (e.g., Schirmer test) in the same or another organ. Furthermore, other possible diagnoses for clinical symptoms must be excluded. No time limit is set for the diagnosis of chronic GVHD. The Working Group recognized 2 main categories of GVHD, each with 2 subcategories. The acute GVHD category is defined in the absence of diagnostic or distinctive features of chronic GVHD and includes (1) classic acute GVHD occurring within 100 days after transplantation and (2) persistent, recurrent, or late acute GVHD (features of acute GVHD occurring beyond 100 days, often during withdrawal of immune suppression). The broad category of chronic GVHD includes (1) classic chronic GVHD (without features or characteristics of acute GVHD) and (2) an overlap syndrome in which diagnostic or distinctive features of chronic GVHD and acute GVHD appear together. It is currently recommended that systemic therapy be considered for patients who meet criteria for chronic GVHD of moderate to severe global severity.

Chronic Disease↗
PubMed2006

Measuring therapeutic response in chronic graft-versus-host disease: National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. Response Criteria Working Group report.

The lack of standardized criteria for quantitative measurement of therapeutic response in clinical trials poses a major obstacle for the development of new agents in chronic graft-versus-host disease (GVHD). This consensus document was developed to address several objectives for response criteria to be used in chronic GVHD-related clinical trials. The proposed measures should be practical for use both by transplantation and nontransplantation medical providers, adaptable for use in adults and in children, and focused on the most important chronic GVHD manifestations. The measures should also give preference to quantitative, rather than semiquantitative, measures; capture information regarding signs, symptoms, and function separately from each other; and use validated scales whenever possible to demonstrate improved patient outcomes and meet requirements for regulatory approval of novel agents. Based on these criteria, we propose a set of measures to be considered for use in clinical trials, and forms for data collection are provided (). Measures should be made at 3-month intervals and whenever major changes are made in treatment. Provisional definitions of complete response, partial response, and progression are proposed for each organ and for overall outcomes. The proposed response criteria are based on current expert consensus opinion and are intended to improve consistency in the conduct and reporting of chronic GVHD trials, but their use remains to be demonstrated in practice.

Adolescent↗
PubMedDate not supplied

[Consensus doesn't always mean agreement: limitations of consensus methods in health services].

Taking decisions in uncertain situations has led to a high use of the consensus methods (Nominal Group Technique, Delphi Method, and Consensus Conferences) in the health services. The review made in this article shows that the appropriate use of these techniques requires a high degree of methodologic precision, especially in relation to the financer's declaration of objectives, the appropriate selection of the participants, previous realization of a synthesis of the preexistent information, the definition of the agreement degree which leads to the consensus and in the evaluation of its impact.

Centers for Disease Control and Prevention, U.S.↗
PubMed1997

Consensus conferences in critical care medicine. Methodologies and impact.

Consensus conferences for the purposes of producing practice guidelines are occurring with increasing frequency both nationally and internationally. The international collaboration of national sciences in these efforts could have a dramatic impact on international standards of care. Too little emphasis is given to conference evaluations in terms of validity of methods, quality of recommendations, and influence on clinical practice and patient outcome. This article provides an overview of consensus methods used to produce guidelines in critical care. It also discusses the strengths and weaknesses of these methods, and how these may influence consensus guidelines. Finally, a brief overview of theoretically sound methods that can serve as benchmarks to evaluate current methods, and the bases for the development of improved methods is provided.

Consensus Statements as Topic↗
PubMed1991

The epistemology and ethics of consensus: uses and misuses of 'ethical' expertise.

In this paper I examine the epistemology and ethics of consensus, focusing on the ways in which decision makers use/misuse ethical expertise. The major questions I raise and tentative answers I give are the following: First, are the 'experts' really experts? My tentative answer is that they are bona fide experts who often represent specific interest groups. Second, is the experts' authority merely epistemological or is it also ethical? My tentative answer is that the experts' authority consists not only in their command over specific matters of fact and/or value, but also in their ability to achieve 'consensus' about what is 'true'/'false', or 'right'/'wrong'. Third, should the authority of expertise be limited? My tentative answer is that it should be limited in the area of facts but especially in the area of values. Persons who are ethics 'experts' must be particularly careful to practice an ethics of persuasion rather than an ethics of compulsion. Their role is not to force their group consensus upon decision makers' individual moral perceptions and deliberations; rather it is to help decision makers come to their own conclusions about what they ought to do.

Advisory Committees↗
PubMed2000

Assessing the effects of thyroid suppression on benign solitary thyroid nodules. A model for using quantitative research synthesis.

Systematic review of the available information with a modified, largely quantitative method of research synthesis disclosed that an initial trial of thyroid hormone suppression therapy leads to clinically significant (> or = 50%) reduction of nodule size or arrest of nodule growth in a subset of patients with benign solitary thyroid nodules. In fact, in addition to objective improvements due to decreasing nodule size, L-T4 suppression therapy may benefit patients by reducing perinodular thyroid volume. Consequently, both pressure symptoms and cosmetic complaints may improve (9, 68). Additional studies for the assessment of the risks versus benefits of supraphysiologic doses of L-T4, the optimal level of thyroid suppression and the dose needed to achieve this magnitude of reduction, the optimal length of the initial trial, and the conditions for the continuation of L-T4 thyroid suppression therapy, as well as the identification of markers for patients most likely to respond to this therapy, are warranted. Finally, quantitative assessment of available evidence as described here may be applicable to the review of other controversial issues as well.

Adult↗