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Toward a consensus on radiobiology teaching to radiation oncology residents.

There are approximately 82 radiation oncology residency programs in the United States, which provide training opportunities for about 400 residents. All accredited radiation oncology residency programs must have at least one basic scientist on the faculty, and it is these individuals who often assume, wholly or in part, the responsibility of teaching radiation and cancer biology to radiation oncology residents in preparation for the American College of Radiology (ACR) In-Training Examination in Radiation Oncology and the American Board of Radiology (ABR) written examinations. In response to a perceived lack of uniformity in radiation and cancer biology curricula currently being taught to residents and a perceived lack of guidance for instructors in formulating course content for this population, a special session was presented at the Forty-eighth Annual Radiation Research Society meeting on April 23, 2001. The session, entitled "Toward a Consensus on Radiobiology Teaching to Radiation Oncology Residents", was focused on issues related to teaching radiobiology to radiation oncology residents and targeted for individuals who actively teach radiation and cancer biology as well as coordinators of residency training programs. The speakers addressed current challenges and future problems facing instructors and programs. Among these were lack of feedback on resident performance on ABR and ACR written examinations and on course content, uncertainty about what topics residents must know to pass the ABR examination, and, in the near future, a reduction (due to retirement) of instructors qualified to teach radiobiology. This article provides a synopsis of the information that was presented during that session, offers a glimpse into how the ABR and ACR examinations are prepared and details of the content of past and future examinations, and summarizes the activities of the Joint Working Group on Radiobiology Teaching which was formed to educate instructors, to establish a consensus for course curricula, and to improve the overall quality of resident teaching.

Consensus Statements as Topic↗

[Consensus conference: methodology and contribution].

A consensus conference is a method used to evaluate a medical process and to elaborate practice guidelines. The goal of consensus conference is to obtain the best possible outcomes for patients. The guidelines are written by a multidisplinary jury which analyses scientific datas and clinical practices. Consensus conference don't resolve all medical problems. It's a good evaluation method for the topics where there are non medical sides, inappropriate medical options or different clinical practices in spite of sufficient scientific datas. Consensus conference use three distinct groups: organization committee, jury and experts. The lectures of the experts and the guidelines must distinguish and clarify which is scientifically proved. Use of biomedical databases and critical analysis of biomedical articles are useful. Practice guidelines must be clear, precise, explicit and useful for clinical practices. Measurement of the real usefulness of consensus conference is difficult: it's the problem of the impact of guidelines on care. Usually it could be realized by survey of clinical practices or drugs consuming. The impact will be better with a large use of media, dissemination of the guidelines in the medical faculties and during professional workshops.

Consensus Statements as Topic↗

The North American Menopause Society develops consensus opinions.

Considerable consultation with experts in the field has led to the conclusions reached in the article entitled "NAMS Consensus Opinion." Both published literature and clinical experience were evaluated by a panel of distinguished experts who convened to prepare their recommendations for the NAMS Board of Trustees. The article may not express the only valid approach to the topic, but readers can be assured that, like all official NAMS materials, it has been drafted and reviewed with the full benefit of the Society's considerable expertise. The Society is grateful to the panelists, and to Novartis Pharmaceuticals Corporation, whose unrestricted educational grant helped to defray costs associated with the conference. We also wish to clarify that although the term "NAMS consensus" is used, one should not assume that every single member of the Society agrees with the published findings. Such a constraint would necessarily prevent any organization from publishing its opinions. The Society hopes that the advice offered will be of assistance to the many different specialists charged with providing health care for the 4,000 women (in the U.S. alone) who are reaching menopause every day. We encourage your comments. You, our readers, will determine the way that future Society opinions will be presented.

Consensus Statements as Topic↗

Statistical concepts in the planning and evaluation of drug safety from clinical trials in drug development: issues of international harmonization.

The assessment of the safety of new drugs during pre-marketing clinical studies is an important and integral part of the drug development and regulatory evaluation process. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory decision-makers of Europe, Japan and the United States of America and the experts from the pharmaceutical industry in the three regions to seek ways to eliminate redundant and duplicative technical requirements among the developed countries for registering new medicinal substances and products. The ICH is developing guidelines or position papers to achieve the goal of harmonizing technical standards in three broad areas, namely, drug efficacy, safety and quality. Within the area of drug safety, this paper will discuss three of the safety topics because of their relevant statistical framework, and because these topics have not, to date, received any attention by the statistical community. The three issues under consideration by the International Conference on Harmonization (ICH), are: 1. Dose-response information to support drug registration (especially dose/toxicity relationships). 2. Studies in support of special populations; Geriatrics, A Draft Guideline. 3. ICH Draft Guideline 3 on 'The extent of population exposure required to assess clinical safety for drugs intended for long-term-treatment of non-life-threatening conditions'. The ICH special population guideline concerning studies in geriatric patients is closely related to a recent Food and Drug Administration 'Guideline for the study and evaluation of gender differences in the clinical evaluation of drugs', which is another example of a 'subgroup' for whom specific interest exists to evaluate drug safety and efficacy.

Age Factors↗

[Impact on the professional practices of French dermatologists of the 2001 consensus conference on the care of immunocompetent patients with cutaneous or mucous membrane herpes infection].

BACKGROUND: Our aim was to assess the impact of the 2001 French Consensus Conference on the professional practices of French dermatologists treating immunocompetent patients with mucocutaneous herpes simplex infection (ocular herpes excluded). This conference was preceded by a survey that revealed a lack of homogeneity in practices. METHODS: A questionnaire (similar to that of 2001) was submitted in 2003 to 205 dermatologists, half of whom had responded to the first survey. It contained 40 questions about diagnosis, prevention and treatment. The analysis compared the answers given in the 2001 survey with those of dermatologists either answering for the first time or answering again in 2003. RESULTS: In 2003, the response rate was of 96% (43% in 2001). Statistically significant changes were obtained for the following items: better knowledge of situations requiring a precise history of herpes infection, dramatic decrease in prescribing herpes serological tests, increase in prescribing serological tests for other sexually transmitted diseases in patients with genital herpes, better knowledge of prevention strategies, decreased intention of prescribing topical antiviral agents, increased intention of using oral antiviral agents in patients with recurrent genital or orofacial herpes and those with recurrent erythema multiforme. No statistically significant improvement was noted regarding: failure to prescribe any direct virology test to confirm herpes infection before prescribing long-term viral treatment, high use of "prophylactic" oral antivirals in patients with recurrence of UV-induced herpes. DISCUSSION: The fact that the telephone survey was conducted by a dermatologist rather than a service provider could account for the very high response rate observed. The utilization of a part of the sample of practitioners surveyed in 2001 lends credibility to the results. Our study nevertheless remains a survey of prescribing intentions rather than of actual practice. While the 2001 consensus conference on the practices of French dermatologists appears to have had a clear effect regarding numerous items, considerable progress is still required in certain diagnostic and therapeutic areas.

Consensus Statements as Topic↗

Recommendations for the management of irritable bowel syndrome in family practice. IBS Consensus Conference Participants.

To help family physicians manage patients with irritable bowel syndrome (IBS), a consensus conference was convened in June 1997 at which 5 internationally recognized experts in IBS presented position papers on selected topics previously circulated to the conference participants. Five working groups comprising family physicians, gastroenterologists and allied health care professionals from across Canada were then charged with developing recommendations for the diagnosis, patient education, psychosocial management, dietary advice and pharmacotherapy, respectively. An evidence-based approach was used where possible; otherwise, recommendations were made by consensus. The participants concluded that family physicians can make a positive diagnosis of IBS using symptom criteria. The pathophysiology is poorly understood, but motility and sensory disturbances appear to play a role. Neither psychological nor specific dietary factors cause IBS, but both can trigger symptoms. Drug therapy is not recommended for the routine treatment of IBS, but short-term trials of drug therapy may be targeted to predominant symptoms in selected patients. A step-wise, patient-centred approach to management is outlined.

Colonic Diseases, Functional↗

Nomenclature of the veins of the lower limbs: an international interdisciplinary consensus statement.

An agreement on anatomic terminology is the foundation for a common language in medical science and for an effective exchange of information. A thorough review of the literature has shown need for revision and extension of the official terminologia anatomica with regard to the veins of the lower limb. The foundation of this consensus document was laid by the faculty at a precongress meeting of The Fourteenth World Congress of the International Union of Phlebology (IUP), held in Rome on September 8-9, 2001, under the auspices of the IUP, the International Federation of Associations of Anatomists (IFAA), and the Federative International Committee on Anatomical Terminology (FICAT). The official names of some veins have been changed according to the guidelines of the FICAT. In addition, previously unnamed veins have received names relevant to their anatomy and clinical significance. Some of the terminology recommendations are innovative, but were judged to be correct by members of the committee.

Anatomy↗

Do consensus conferences work? A process evaluation of the NIH Consensus Development Program.

The purpose of this evaluation study is to identify problems and suggest modifications in the NIH Consensus Development Program. The current program consists of three-day conferences in which experts assess medical technologies for issues of efficacy, safety, conditions of use, and other related topics (e.g., costs and social impact). Eight consensus conferences held between 1980 and 1982 were studied in depth using a variety of methods; five of the conferences were investigated concurrently. In addition, archival material was examined for all but one of the 33 conferences held up to that time, and four planning meetings for future conferences were observed. The delay in publishing our findings provided an opportunity to examine the changes introduced by NIH; it also allowed us to avoid the criticism of numerous prior evaluations for finding fault with programs that are still developing. NIH adopted many of the recommendations in our evaluation report and has investigated others. Based on our evaluation and more recent evidence, however, we conclude that the major problem that was uncovered--selection bias, particularly with respect to the choice of questions and panelists--remains a significant threat to the credibility of the consensus process. More specifically, the results indicate that controversial issues cannot be properly addressed within the present conference format, although that was one of its major purposes. Recommendations for improving the consensus process are presented, as are their implications for a larger set of consensus activities that are currently being conducted.

Consensus Statements as Topic↗

[Peptic ulcer, functional dyspepsia, Helicobacter pylori: a 1998 stock-taking on the topic of their correlation and therapeutic strategies].

While the correlation between Helicobacter pylori and peptic ulcer is accepted worldwide, the role of Hp in functional dyspepsia is still a debatable issue. Therefore, Hp eradication in all dyspeptic patients has both supporters and opponents. In contrast, anti-Hp regimens are increasingly well defined, most convincing treatments being triple therapies consisting of one proton pump inhibitor (PPI) or ranitidine bismuth citrate (RBC) plus two antimicrobials. Duration of anti-Hp regimens varies from 2 weeks (more usually adopted in USA) and 1 week (more usually adopted in Europe). Due to the short and simple anti-Hp triple therapies, side effects prove to be few and negligible and patient compliance is significantly better. By contrast, Hp resistance to extensively used antimicrobials, such as metronidazole and clarithromycin, is more than an emerging problem causing significantly lower eradication rates. Very recent data indicate that RBC-based triple therapy is much less affected by the helicobacterial resistance, and is also effective in non-responders to a PPI-based triple therapy.

Anti-Bacterial Agents↗

Evaluation of the management of rectal cancers before and after the consensus conference in France.

OBJECTIVES: Population-based registries are the best way to draw a picture of the management of a disease. The purpose of this study was to analyse therapeutic modalities for rectal cancers in seven French areas in 1990 and 1995, before and just after a consensus conference devoted to this topic. METHODS: A community-based series of 945 patients (402 in 1990, 543 in 1995) with rectal cancer was used to assess therapeutic modalities and stage at diagnosis. RESULTS: Colonoscopy was performed in most of the cases (90% in 1990 and 1995). There was significant change between 1990 and 1995 in stage at diagnosis and cancer resection. The rate of continence-preserving operations was similar in 1990 and in 1995, as was the rate of adjuvant radiotherapy. There was a shift between 1990 and 1995 from postoperative radiotherapy to preoperative radiotherapy. There was an increase in the use of adjuvant chemotherapy. CONCLUSION: Changes in the management of rectal cancer in France over the past few years have concerned mainly resection rate, stage at diagnosis and adjuvant therapy. The recommendations of the consensus conference were followed only partly, in particular for adjuvant preoperative radiotherapy, which has not reached its full development, and adjuvant chemotherapy, which tends to be overprescribed, considering how little is known about its effectiveness.

Aged↗

The French clinical guidelines and medical references programme: development of 48 guidelines for private practice over a period of 18 months.

The French medical profession and health insurance organizations have jointly committed themselves to a concept termed the 'medical regulation' of care. They decided to promote the quality of health care, judging that an approach based on quality was the best option for reducing the increase in health costs. The Clinical Guidelines and Medical References programme was entrusted to ANDEM (Agence Nationale pour le Développement de L'Evaluation Médicale). Fifty working groups (669 experts) and 50 reading groups (1643 experts) met from June 1994 to November 1995 to produce guidelines. Learned societies were involved to propose experts. Hospital practitioners, doctors who specialized in the topic in question and those who did not had equal representation in the groups. The method consisted of a review of the literature to determine the level of scientific evidence. ANDEM's Scientific Council suggested modifications to the groups and agreed to disseminate 48 of the 50 texts. Careful observation of the operation of the groups identified factors that can positively influence the nature of the discussions and help avoid conflict: an abundance of high-quality literature, an understanding of clinical research methodology, the existence of guidelines from different institutions or different countries tending towards the same conclusions, good initial work carried out by the chairperson and the project manager, a limit to the number of questions asked of the group, the chairperson having good people skills and meeting-management skills, and an absence of professional and financial consequences for the participants. Good management of working groups is an additional factor in ensuring success. The regulatory medical references programme has led to changes of behaviour within the medical profession.

Consensus Statements as Topic↗

An assessment of inter-rater agreement of the literature filtering process in the development of evidence-based dietary guidelines.

OBJECTIVE: To determine whether the literature filtering process, a vital initial component of a systematic literature review, could be successfully completed by nutrition professionals or non-professionals. DESIGN: Using a diet-disease relationship as the guideline topic, inter-rater agreement for the title and abstract filtering processes between and among professionals and non-professionals was assessed and compared with an expert reference standard. Predetermined eligibility criteria were applied by all raters to 185 titles and 90 abstracts. Filtering decisions were initially made independently and then revised after a within-pair consensus meeting. SUBJECTS: The raters were six dietitians (RD) and six nutrition graduate students (Grad). To assess inter-rater agreement (reliability), each group was divided into three pairs. RESULTS: Weighted and unweighted kappa statistics and percentage agreement were calculated to determine the inter-rater agreement within pairs. Sensitivity and specificity estimates were determined by comparing responses with those of an expert reference standard. Overall, Grad pairs demonstrated greater inter-rater agreement than RD pairs for title filtering (P<0.05); no differences were observed for abstract filtering. Compared with the expert reference standard, every rater and pair had false-negative responses for both title and abstract filtering. CONCLUSIONS: After consensus meetings, both RDs and Grads were comparable in their agreement on title and abstract filtering, although important differences remained compared with the expert reference standard. This study provides preliminary findings on the value of utilising a non-expert pair in developing guidelines, and suggests that the literature filtering process is complex and quite subjective.

Adult↗

A methodology for consensus conferences. Société Royale Belge de Gastro-entérologie.

Consensus conference is one of the methods proposed to develop clinical practice guidelines. This method is used when the topic is limited to a small numbers of questions (4 to 6) and when there is a controversy. This process is based on the meeting of a jury which reviews the scientific information provided by the literature and presented by experts. The consensus conference consists of three phases: A preliminary phase during which questions are well defined, experts and jury are chosen by a panel of organizers usually designed by scientific societies. In the jury there are multidisciplinary specialists, generalists practitioners and other people such as nurses, economists, ... Experts conduct the review and analysis of the literature. The jury is informed by organizers about the methodology of a consensus conference and about the quality of scientific information available. The second phase is the plenary session of the consensus conference. It lasts one or two days during which the expert's texts and presentation are discussed by the jury and a public. The third phase is the actual meeting of the jury, behind closed doors, during which conclusions and clinical practice guidelines are formulated. Dissemination of these guidelines is one of the major factors determining the impact of the consensus conference. These guidelines are usually mailed directly to the professionals concerned and published in scientific journals and dissiminated via professional associations, universities, post graduate training bodies, ... The impact of the conference is assessed one or two years after and compared by the same method with the results of a preliminary survey before the conference. This process is long and expensive but is increasingly used because of the necessity for physicians to assimilate and to integrate into their daily clinical practice an increasing mass of scientific information.

Belgium↗

Consensus development methods: a review of best practice in creating clinical guidelines.

BACKGROUND: Although there is debate about the appropriate place of guidelines in clinical practice, guidelines can be seen as one way of assisting clinicians in decision-making. Given the likely diversity of opinion that any group of people may display when considering a topic, methods are needed for organising subjective judgements. Three principal methods (Delphi, nominal group technique, consensus development conference) exist which share the common objective of synthesising judgements when a state of uncertainty exists. OBJECTIVES: To identify the factors that shape and influence the clinical guidelines that emerge from consensus development methods and to make recommendations about best practice in the use of such methods. METHODS: Five electronic databases were searched: Medline (1966-1996), PsychLIT (1974-1996), Social Science Citation Index (1990-1996), ABI Inform and Sociofile. From the searches and reference lists of articles a total of 177 empirical and review articles were selected for review. RESULTS: The output from consensus development methods may be affected by: the way the task is set (choice of cues, recognition of contextual cues, the focus of the task, the comprehensiveness of the scenarios); the selection of participants (choice of individuals, degree of homogeneity of the group, their background, their number); the selection and presentation of scientific information (format, extent to which its quality and content is assessed); the way any interaction is structured (number of rating rounds, ensuring equitable participation, physical environment for meetings); and the method of synthesising individual judgements (definition of agreement, rules governing outliers, method of mathematical aggregation). CONCLUSIONS: Although a considerable amount of research has been carried out, many aspects have not been investigated sufficiently. For the time being at least, advice on those aspects has, therefore, to be based on the user's own commonsense and the experience of those who have used or participated in these methods. Even in the long term, some aspects will not be amenable to scientific study. Meanwhile, adherence to best practice will enhance the validity, reliability and impact of the clinical guidelines produced.

Benchmarking↗

A paradigm for consensus. The University Hospital Consortium guidelines for the use of albumin, nonprotein colloid, and crystalloid solutions.

OBJECTIVE: To develop contemporary, comprehensive guidelines for the appropriate and efficient use of albumin, nonprotein colloid, and crystalloid solutions. DESIGN: A systematic, literature-based, consensus exercise employing a modified Delphi method. PARTICIPANTS: Thirty-one medical and allied health professionals from 26 University Hospital Consortium (Oak Brook, Ill) member institutions were initially chosen to participate. Participants were selected on the basis of their recognized research in the use of albumin, nonprotein colloid, and crystalloid solutions, and/or experience in the review of appropriateness of such use. A total of 24 participants completed the exercise. MAIN OUTCOME MEASURES: Group responses were statistically analyzed in an iterative consensus development process. Five separate questionnaire rounds were designed to establish criteria for the appropriate use of albumin, nonprotein colloid, and crystalloid solutions. RESULTS: Consensus guidelines were developed outlining the appropriate use of these products for 12 clinical indications, including hemorrhagic shock, nonhemorrhagic (maldistributive) shock, hepatic resection, thermal injury, cerebral ischemia, nutritional intervention, cardiac surgery, hyperbilirubinemia of the newborn, cirrhosis and paracentesis, nephrotic syndrome, organ transplantation, and plasmapheresis. CONCLUSIONS: The Delphi method, a systematic, literature-based consensus process, was shown to be useful in the development of complex clinical practice guidelines for the use of albumin, nonprotein colloid, and crystalloid solutions. It is anticipated that the guidelines will assist health care providers to develop local institutional policies and procedures for the appropriate and efficient use of albumin and albumin alternatives. Institutions reviewing and updating existing local guidelines may use the University Hospital Consortium guidelines as a model for comparison.

Academic Medical Centers↗

Prevention of venous thromboembolism: adherence to the 1995 American College of Chest Physicians consensus guidelines for surgical patients.

BACKGROUND: The American College of Chest Physicians addressed the dilemma of identifying optimal therapy for venous thromboembolism (VTE) prophylaxis and published their Fourth Consensus Conference on Antithrombotic Therapy in 1995, with recommendations for prophylactic therapy. Despite these recommendations, appropriate VTE prophylactic therapy is underused. OBJECTIVES: To examine routine practices in the prevention of VTE in high-risk surgical patients and to determine the extent of adoption of grade A prophylactic therapies as recommended by the American College of Chest Physicians. METHODS: Retrospective medical record review in 10 teaching or community-based hospitals located in the United States. Medical charts of 1907 patients were randomly selected for review from the population of patients who underwent high-risk major abdominal surgery, total hip replacement, hip fracture repair, or total knee replacement between January 1, 1996, and February 28, 1997. RESULTS: Of 1907 patients, VTE prophylaxis was used in 89.3%; use was 93.7% in each of the 3 orthopedic surgery groups and 75.2% in the high-risk major abdominal surgery group. The percentage of patients receiving grade A therapy was highest in the hip replacement group (84.3%) vs. the other groups (knee replacement, 75.9%; hip fracture repair, 45.2%; abdominal surgery, 50.3%). CONCLUSIONS: The use of grade A prophylaxis was related to the type of surgery, with the highest use seen in total hip replacement and the lowest in hip fracture repair. One in 4 patients who underwent high-risk major abdominal surgeries failed to receive any form of VTE prophylaxis. Publication of consensus statements alone may be insufficient to ensure the incorporation of important new clinical information into routine practice.

Adult↗

Consensus against both endarterectomy and routine screening for asymptomatic carotid artery stenosis. Canadian Stroke Consortium.

BACKGROUND: Despite several randomized controlled trials, the role of carotid endarterectomy for asymptomatic patients is controversial. Validated evidence-based guidelines are needed. METHODS: Thirty-five members of the Canadian Stroke Consortium, an independent body of cerebrovascular disease experts, reviewed evidence-based guidelines developed by the Canadian Task Force on the Periodic Health Examination. We held 3 rounds of Delphi consensus to solicit opinion and agreement. RESULTS: We found a high level of interrater agreement for all guidelines using multiple statistical measures. Members agreed that evidence is insufficient to endorse carotid endarterectomy for asymptomatic patients with angiographically proven stenosis of more than 60% (kappa = 0.70, P < .01). Reasons cited included concern over the reproducibility of low surgical morbidity rates in the community at large, the questionable clinical benefit conferred by surgery, and the lack of proven reduction in the risk of major disabling stroke. Screening the general population for asymptomatic stenosis was unanimously rejected. Also, screening even patients with risk factors or proven atherosclerosis at other sites was not endorsed (kappa = 0.91 and kappa = 0.79, respectively, both P < .01). CONCLUSIONS: There is insufficient evidence to recommend carotid endarterectomy for asymptomatic patients. Evidence is also insufficient to endorse a screening strategy even for patients with risk factors for carotid disease. While stroke prevention remains a critical goal, we do not recommend that it be accomplished by screening or by performing carotid surgery in asymptomatic patients.

Canada↗