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Criteria list for assessment of methodological quality of economic evaluations: Consensus on Health Economic Criteria.

OBJECTIVES: The aim of the Consensus on Health Economic Criteria (CHEC) project is to develop a criteria list for assessment of the methodological quality of economic evaluations in systematic reviews. The criteria list resulting from this CHEC project should be regarded as a minimum standard. METHODS: The criteria list has been developed using a Delphi method. Three Delphi rounds were needed to reach consensus. Twenty-three international experts participated in the Delphi panel. RESULTS: The Delphi panel achieved consensus over a generic core set of items for the quality assessment of economic evaluations. Each item of the CHEC-list was formulated as a question that can be answered by yes or no. To standardize the interpretation of the list and facilitate its use, the project team also provided an operationalization of the criteria list items. CONCLUSIONS: There was consensus among a group of international experts regarding a core set of items that can be used to assess the quality of economic evaluations in systematic reviews. Using this checklist will make future systematic reviews of economic evaluations more transparent, informative, and comparable. Consequently, researchers and policy-makers might use these systematic reviews more easily. The CHEC-list can be downloaded freely from http://www.beoz.unimaas.nl/chec/.

Cost-Benefit Analysis↗

Treatment adherence in schizophrenia. Spanish clinical consensus.

Objective. Establish a Spanish Consensus on Therapeutic Compliance in Schizophrenia. Material and methods. An experts committee designed a specific questionnaire having 40 questions and 293 options. The questions referred to the definition and general assessment of compliance in schizophrenia, factors involved, intervention strategies in outpatients and in acute units and management of oral and long duration injectable antipsychotic drugs and other non-pharmacological therapies. First, second or third line strategy values of choice were assigned according to the answers obtained for each item. The questionnaire was sent to 383 psychiatrists of a Therapeutic Compliance Work Group. A total of 326 answers were received with an electronic system that guaranteed their confidentiality. Results and conclusions. There is maximum agreement on considering the seriousness of the compliance problem, its repercussion in relapses, the patient's course and increase in health care costs. The strategies preferred to evaluate compliance are: counting of the injectable drug administration and determination of plasma concentrations. The Consensus considers that specific intervention is necessary when the patient has already suffered several relapses due to low therapeutic compliance, when null awareness of disease is detected or if there is comorbidity with toxic consumption. Psychoeducational is the non-pharmacological strategy having the greatest consensus grade if intervention is needed. Treatments with atypical injectable, long duration, antipsychotic drugs obtain the best grade in accordance with pharmacological strategies of first choice, in different clinical situations to avoid or improve therapeutic adherence. Key words: Adherence. Compliance. Schizophrenia. Consensus.

Antipsychotic Agents↗

Italian Consensus Conference--overweight, obesity and health.

On 5 and 6 April 1991, at the National Research Council (CNR) in Rome, a Consensus Conference on the relationship between overweight, obesity and health was held. The conference was sponsored by FATMA (Applied Project on Disease Factors of the CNR) and UICO (Italian Society for the Study of Obesity) with the purpose of establishing guidelines for health employees. The development of the conference followed the methodology set down by OMAR to obtain a rational and significant consensus on the answers to six basic questions prepared by the planning committee. The questions were the pivotal point of the conference and were brought to the attention of all the attendees and widely diffused among the medical community; they were proposed with the aim of giving an exhaustive definition of obesity, to investigate its relationship with mortality and morbidity, to highlight its social characterization, to indicate methods of evaluation and recommendations for weight loss, to select groups at risk, and to focus general guidelines for research. After the presentation of the state of the art on 18 topics by experts in the field, the 22 members of the consensus panel, impartial experts from a vast area of the scientific community, discussed a draft document representing the answers to the questions, which was subsequently submitted to the 307 attendees, discussed and then approved. This paper is the definitive document of the Consensus Conference. The introduction explains the reasons which led to the decision to promote the conference six years after the one held in the United States. The methodology is then set out. The questions are answered in the form of recommendations and backed up by data and scientific evidence from the literature.

Body Weight↗

[Consensus early treatment with zidovudine].

The aim was to reach national consensus on the moment early treatment with the antiretroviral drug zidovudine should be started and on the dosing schedule to be used. On the initiative and under the auspices of the National AIDS Therapy Evaluation Centre a consensus meeting of Dutch AIDS treatment specialists was organised on March 6, 1991. A number of expert-speakers made recommendations on the basis of currently available information. These were amended in a plenary discussion. Subsequently the participants could comment upon a draft consensus document. Premises were that the starting point of treatment should be easily applicable and that the moment chosen should be neither too early nor too late in the course of HIV infection. The zidovudine dose had to be an effective one, and the dosing schedule user-friendly. The consensus was that zidovudine should be started in asymptomatic HIV-infected persons at a peripheral blood CD4+ cell count less than or equal to 0.3 x 10(9)/l. In the presence of additional laboratory indicators of a poor prognosis and in persons with early clinical symptoms of HIV infection, it was preferred to start treatment at a CD4+ cell count less than or equal to 0.4 x 10(9)/l. In view of the natural fluctuation in the number of CD4+ cells it was felt to be injudicious to act upon a single count. The recommended zidovudine dose is 200 mg 3 times daily. In case of serious toxicity the dose should be lowered to 100 mg 3 times daily, although for this dose no long-term efficacy data are available.

Acquired Immunodeficiency Syndrome↗

[Italian Consensus Conference; overweight, obesity and health (ICC S.O.S. 1991)].

On April 5th and 6th 1991, at the National Research Council (CNR) in Rome, a Consensus Conference on the relationship between Overweight, Obesity and Health was held. The Conference was sponsored by FATMA (Applied Project on Disease Factors of the CNR) and UICO (Italian Society for the Study of Obesity) with the purpose of establishing guidelines for health employees. The development of the Conference followed the methodology set down by OMAR to obtain a rational and significant consensus on the answers to 6 basic questions prepared by the Planning Committee. The questions were the pivotal point of the Conference and were brought to the attention of all the attendees and widely diffused among the medical community; they were proposed with the aim of giving an exhaustive definition of obesity, to investigate its relationship with mortality and morbidity, to highlight its social characterization, to indicate methods of evaluation and recommendations for weight loss, to select groups at risk, and to focus general guidelines for research. After the presentation of the state of the art on 18 topics by experts in the field, the 22 members of the Consensus Panel, impartial experts from a vast area of the scientific community, discussed a draft document representing the answers to the questions, which was subsequently illustrated to the 307 attendees, discussed and then approved. This paper is the definitive document of the Consensus Conference. The introduction explains the reasons which led to the decision to promote the Conference six years after the one held in the United States. The methodology is then set out. The questions are answered in the form of recommendations and backed up by data and scientific demonstrations from the literature.

Adolescent↗

Report of the Canadian Cardiovascular Society's consensus conference on the Management of the Postmyocardial Infarction Patient.

In October 1989, the Canadian Cardiovascular Society announced a program to achieve consensus on important issues in the care of patients with cardiovascular disease. This report on the management of the postmyocardial infarction patient represents the first in a series of these consensus conferences. The process for establishing consensus recommendations involved several steps. A primary panel of 11 experts from various fields was selected to review the available clinical evidence and to make a list of recommendations about management decisions in the postmyocardial infarction period. The initial report was distributed to a secondary panel of 16 reviewers* representing allied health care constituencies from across Canada. On the basis of the critical reviews and feedback from these reviewers, a revised report was distributed to all members (over 800) of the Canadian Cardiovascular Society for further review and feedback. This iterative approach resulted in a penultimate report that was presented at a plenary session of the annual scientific meeting of the Canadian Cardiovascular Society on Oct. 18, 1990, in Halifax, NS. On the basis of discussion and feedback from this symposium, the consensus review was completed.

Canada↗

Effects of the National Institutes of Health Consensus Development Program on physician practice.

The effects of the National Institutes of Health Consensus Development Program on physician behavior were investigated. The medical records of 2770 patients treated in ten hospitals throughout the state of Washington were reviewed to determine if quality of care improved with respect to 12 recommendations put forth by four consensus panels concerning surgical management of primary breast cancer, the use of steroid receptors in breast cancer, cesarean childbirth, and coronary artery bypass surgery. Care was studied during 24 months before and 13 to 24 months after each consensus conference. Results showed that the conferences mostly failed to stimulate change in physician practice, despite moderate success in reaching the appropriate target audience. It was concluded that the consensus development conference is an important educational tool whose effects might be enhanced by focusing on areas of practice that need improvement and by encouraging follow-up programs at the state and local level.

Breast Neoplasms↗

Designing human consensus antibodies with minimal positional templates.

A humanized antibody retains from the original murine antibody the variable region amino acid residues that are required for antigen binding. These generally include the grafted complementarity determining regions, as well as a few key framework residues. Although the remainder of the framework sequences are imported from a human antibody, they nevertheless differ at a few positions from the human consensus sequences. These atypical residues, which arose by somatic mutation during the affinity maturation of the chosen human antibody, could elicit an immune response in some of the patients receiving the humanized antibody. Thus, ideally one should, instead, choose human consensus frameworks for humanizing murine antibodies. Because there is a different consensus sequence for each of the subclasses of variable light and heavy chains, a method is needed to choose the most appropriate one. We are developing a minimal positional template for such a purpose. A minimal positional template indicates which positions in the variable region frameworks are absolutely required for maintaining the integrity of the binding domains. Therefore, to choose a human framework for humanization, one screens the available human consensus sequences for those that are most similar to the original murine sequence, specifically at the positions indicated by the template. In the subsequent humanization protocol, one then retains all of the murine residues found in the positions indicated in the template while humanizing the residues found at all other positions. A conservative positional template has been applied to the humanizations of the antibreast epithelial mucin antibodies BrE-3 and KC4-G3 without loss of binding affinity. Now we are using progressive cycles of computer modeling and laboratory testing to develop a minimal template. The first of such cycles produced template B, which has been used successfully in the humanization of the antibreast epithelial antigen BA46 antibody Mc3. This prompted us to design template C, which further approaches the desired minimal template. Future constructs will test the validity of this template as well as the validity of this novel humanization approach.

Amino Acid Sequence↗

Is consensus reproducible? A study of an algorithmic guidelines development process.

The authors evaluated the reproducibility of a clinical algorithm consensus development process across three different physician panels at a health maintenance organization. Physician groups were composed of primary care internists, who were provided with identical selections from the medical literature and first-draft "seed" algorithms on the management of two common clinical problems: acute sinusitis and dyspepsia. Each panel used nominal group process and a modified Delphi method to create final algorithm drafts. To compare the clinical logic in the final algorithms, the authors applied a new qualitative and quantitative comparison method, the Clinical Algorithm Patient Abstraction (CAPA). Dyspepsia algorithms from all physician groups recommended empiric anti-acid therapy for most patients, favored endoscopy over barium swallow, and had very similar indications for endoscopy. The average CAPA comparison score among final physician algorithms was 6.1 on a scale of 0 (different) to 10 (identical). Sinusitis algorithms from all groups proposed empiric antibiotic therapy for most patients. Indications for sinus radiographs were similar between two algorithms (CAPA = 4.9), but differed significantly in the third, resulting in lower CAPA scores (average CAPA = 1.9, P < 0.03). The clinical similarity of the algorithms produced by these physician panels suggests a high level of reproducibility in this consensus-driven algorithm development process. However, the difference among the sinusitis algorithms suggests that physician consensus groups using a consensus process that a health maintenance organization can do with limited resources will produce some guidelines that vary due to differences in interpretation of evidence and physician experience.

Acute Disease↗

Building consensus for nephrology nursing practice.

Building consensus for nephrology nursing practice was the theme for the American Nephrology Nurses' Association's (ANNA's) 1994 Clinical Concerns Meetings in Chicago and LaJolla, California respectively. This article emphasizes the importance of consensus building, traditional approaches to consensus conferences, and the inherent risks in conducting such a conference. Additionally, the consensus conference design and steps leading to a final working document are presented by members of the Clinical Concerns Planning Committee.

Consensus Statements as Topic↗

Do consensus conferences influence their participants?

OBJECTIVE: To determine whether participation in a consensus conference on the assessment of dementia would influence conference participants with respect to their recommendations to primary care physicians for the assessment of dementia. DESIGN: Questionnaire before and after the conference. SETTING: Canadian Consensus Conference on the Assessment of Dementia, held in Montreal, Oct. 5 and 6, 1989. PARTICIPANTS: All 38 experts representing relevant health disciplines who participated in the consensus conference; 36 completed both questionnaires. OUTCOME MEASURES: Participants' opinion before and after the conference as to how frequently each of 28 manoeuvres (12 blood tests, 4 neurologic imaging procedures, 4 types of consultation and 8 "other" tests) should be ordered by primary care physicians as part of an assessment of a patient with dementia suspected in clinical grounds. RESULTS: For 18 (64%) of the 28 manoeuvres (10 of the 12 blood tests, 3 of the 4 neurologic imaging procedures and 5 of the 8 "other" tests), there was a shift in opinion after the conference toward recommending that primary care physicians order them less often; for 10 of these 18 (5 blood tests and 5 "other" tests) the shift was statistically significant. For the remaining 10 manoeuvres (36%) the shift in opinion was toward a recommendation that primary care physicians order them more often; the shift was not statistically significant for any of these 10 manoeuvres. CONCLUSION: Expert members of a consensus conference are influenced by the process of having participated in such a conference and are capable and willing to chance their initial recommendations when confronted with relevant data.

Clinical Laboratory Techniques↗

European consensus development conference on menopause. European Menopause Society.

A Consensus Development Conference was organized by the European Menopause Society (EMS) and held from September 8-10, 1995 in Montreux, Switzerland. The consensus was based on public lectures presented by international experts. More than 1300 people interested in the menopause assisted at the presentations, including representatives of the European National Menopause Societies, the International Menopause Society, the pharmaceutical industry and several national health services. After a closed meeting, the panel presented its proposition to the delegates and discussed the Consensus Proposition with the audience before the final proposition was adopted. The aim of the EMS was to present common basic principles accepted by all European countries. Such a consensus has been missing until now, when the multitude of different and sometimes contradictory approaches in use today in Europe are considered.

Cardiovascular Diseases↗

Duration of antibiotic treatment in surgical infections of the abdomen. Introduction--the different ways to reach consensus.

The many interrelated issues concerning administration of antibiotics following operations for abdominal contamination and infection were a powerful impetus to create this Discussion Forum in The European Journal of Surgery, which focuses on the duration of administration-a previously neglected topic. The guidelines presented herein are not based on previous randomised trials alone, nor are they prescribed by dictatorship of one person. Instead, they are proposed by a steering committee in the form of a table and are confirmed by consensus of many experts. The science of consensus has to be recognized in surgery. The Discussion Forum offers written judgements that provide more details than the usual Consensus Development Conference statements. It can be used for a nominal group process organized by sepsis trial groups and may be of value for a consensus-based treatment of individual patients.

Abdomen↗

Increasing consensus accuracy in DNA fragment assemblies by incorporating fluorescent trace representations.

We present a new method for determining the consensus sequence in DNA fragment assemblies. The new method, Trace-Evidence, directly incorporates aligned ABI trace information into consensus calculations via our previously described representation, Trace-Data Classifications. The new method extracts and sums evidence indicated by the representation to determine consensus calls. Using the Trace-Evidence method results in automatically produced consensus sequences that are more accurate and less ambiguous than those produced with standard majority-voting methods. Additionally, these improvements are achieved with less coverage than required by the standard methods-using Trace-Evidence and a coverage of only three, error rates are as low as those with a coverage of over ten sequences.

Algorithms↗

Classification and grading of chronic venous disease in the lower limbs. A consensus statement. Ad Hoc Committee, American Venous Forum.

Advances in modern technology have made available a large number of both invasive and non-invasive investigations that can provide information not only on the presence, absence or anatomic extent but also quantitation of the abnormalities. It was soon realised that the combinations of presence, absence, extent and severity of reflux and/or obstruction in the deep, superficial or perforating veins are so large that the classification of chronic venous disease would be a major challenge. This challenge has been taken up by the Consensus Committee which met in Maui on 22-26 February 1995. The Consensus that developed is in three parts. Part I deals with a classification system that covers the Clinical picture, the Etiology, the Anatomic distribution and the Pathophysiology (the CEAP Classification). Part II suggests a scoring system intended to be evaluated on patients classified according to the CEAP classification, and Part III provides guidelines on the use of various investigations which according to the current medical literature will aid in the classification. The Consensus Committee has retained the copyright of the document so that it can be made available for reproduction to all interested parties. Reproduction is free provided there is no alteration and it is always reproduced in its entirety. The development of this consensus document is a continuous process. Suggestions for improvement are expected from all involved in the study and management of patients with chronic venous disease. The classification has already been presented and debated at several national and international meetings and plans for an updated version are already in progress.

Chronic Disease↗

Opinions regarding the diagnosis and management of venous thromboembolic disease. ACCP Consensus Committee on Pulmonary Embolism. American College of Chest Physicians.

PURPOSE: The purpose of this consensus report was to address clinically relevant questions related to the diagnosis and management of acute pulmonary embolism and deep venous thrombosis. BACKGROUND: Physicians are often forced to make decisions about the diagnosis and management of pulmonary thromboembolism even though there are only limited data to guide them. METHODS: We assessed the relevant literature regarding clinical trials according to levels of evidence. The data on which the opinions of the committee were made were sparse. The consensus opinions, therefore, were often based on experience or intuition, rather than firm data. RESULTS: Consensus opinions were given in regard to eight clinically relevant questions. CONCLUSION: We hope that the consensus opinions of this committee will assist others in making clinical decisions while we all await prospective investigations.

Acute Disease↗

Diagnosis and management of very rare primary arrhythmia syndromes in children and adults: a Clinical Consensus Statement of the European Heart Rhythm Association of the ESC and the Association of Cardiovascular Nursing & Allied Professions of the ESC, endorsed by the Association for European Paediatric and Congenital Cardiology.

Very rare and ultra-rare primary inherited arrhythmia syndromes (IAS) represent a heterogeneous group of disorders associated with a significant risk of sudden cardiac death, often manifesting from foetal life to early adulthood. Current guidelines primarily address more common IAS and provide limited, non-specific recommendations for these rare entities, particularly in paediatric populations. This European Heart Rhythm Association Clinical Consensus Statement, developed in collaboration with the Association of Cardiovascular Nursing and Allied Professions and endorsed by the Association for European Paediatric and Congenital Cardiology, integrates available evidence with expert opinion. Recommendations were formulated through structured discussion and voting, following ESC consensus methodology, with a focus on clinically actionable gene-disease associations. The document provides a comprehensive framework for the diagnosis and management of very rare IAS, including calmodulinopathies, Andersen-Tawil syndrome, Timothy syndrome, TRDN-related disease, calcium release deficiency syndrome, and other atypical channelopathies. It highlights age-specific clinical presentations, the importance of genetic testing, and tailored therapeutic strategies, including pharmacological treatments, left cardiac sympathetic denervation, and selective use of implantable cardioverter-defibrillators. Special attention is given to paediatric considerations, foetal diagnosis, and the role of multidisciplinary care. The document also addresses arrhythmic risk in metabolic and cardiomyopathic conditions, as well as the importance of molecular autopsy and family screening in sudden unexplained death. This consensus document fills a critical gap by providing expert-driven, pragmatic guidance for the management of very rare IAS across the lifespan. It underscores the need for specialized care, international collaboration, and prospective registries to improve evidence generation, risk stratification, and patient outcomes in this vulnerable population.

Humans↗

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↗