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Evidence-based use of methotrexate in children with rheumatic diseases: a consensus statement of the Working Groups Pediatric Rheumatology Germany (AGKJR) and Pediatric Rheumatology Austria.

Juvenile idiopathic arthritis (JIA) is the most common diagnosis in children and adolescents with rheumatic disorders. In many children and adolescents, JIA is successfully treated with non-steroidal anti-inflammatory drugs (NSAID) and physiotherapy. However, in a significant number of cases the disease is resistant to this therapy, and treatment with "second line" disease-modifying antirheumatic drugs (DMARDs) is required. Methotrexate (MTX) is frequently referred to as "first-choice second-line agent" for the treatment of JIA. To increase drug safety, the Working Groups for Children and Adolescents with Rheumatic Diseases in Germany (AGKJR) and Pediatric Rheumatology Austria have initiated the formulation of evidence-based recommendations. Evidence is based on consensus expert meetings, a MEDLINE search with the key words "Methotrexate" and "juvenile arthritis" limited to age 0-18 years, standard textbooks and review articles, data from the central registry of the German Research Center for Rheumatic Diseases (Deutsches Rheumaforschungszentrum Berlin DRFZ), experience with MTX in adults with rheumatoid arthritis (RA), and recommendations of the German Society of Rheumatology (DGRh). Based on these data, evidence and recommendations are graded, and evidence-based recommendations for the use of MTX in children and adolescents with rheumatic disease are presented.

Adolescent↗

Survivors of out-of-hospital cardiac arrest with apparently normal heart. Need for definition and standardized clinical evaluation. Consensus Statement of the Joint Steering Committees of the Unexplained Cardiac Arrest Registry of Europe and of the Idiopathic Ventricular Fibrillation Registry of the United States.

BACKGROUND: A wide variety of structural abnormalities are associated with the vast majority of cardiac arrests. However, there is no evidence of structural heart disease in approximately 5% of victims of sudden death, indicating that cardiac arrest in the absence of organic heart disease is more common than previously recognized. The risk of recurrence and the acute and long-term response to therapy are important but unanswered questions. Data from the small series reported so far are of limited value because of the lack of uniform criteria to define and diagnose idiopathic ventricular fibrillation (IVF). METHODS AND RESULTS: This report originates from a Consensus Conference convened by the Steering Committees of the European (UCARE) and North American (IVF-US) Registries on IVF under the auspices of the Working Group on Arrhythmias of the European Society of Cardiology. Its objective is to provide a unified definition of IVF and to outline the investigations necessary to make this diagnosis. Minimal diagnostic tests for the exclusion of an underlying structural heart disease include non-invasive (blood biochemistry, physical examination and clinical history, ECG, exercise stress test, 24-hour Holter recording, and echocardiogram) and invasive (coronary angiography, right and left ventricular cineangiography, and electrophysiological study) examinations. Programmed electrical stimulation, ventricular biopsy, and ergonovine test during coronary angiography are recommended but not mandatory. CONCLUSIONS: It is recognized that despite careful evaluation, conditions such as focal cardiomyopathy, myocarditis, or fibrosis and transient electrolyte abnormalities may remain silent. Therefore, patients should undergo careful follow-up, with noninvasive tests repeated every year. The existence of a unified terminology will allow meaningful comparison of data collected by different investigators and will thus contribute to a better understanding of IVF.

Diagnosis, Differential↗

Living anatomy of the atrioventricular junctions. A guide to electrophysiological mapping. A Consensus Statement from the Cardiac Nomenclature Study Group, Working Group of Arrythmias, European Society of Cardiology, and the Task Force on Cardiac Nomenclature from NASPE. North American Society of Pacing and Electrophysiology.

Current nomenclature for atrioventricular junctions derives from a surgically distorted view, placing the valvar rings and the triangle of Koch in a single plane with antero-posterior and right-left lateral coordinates. Within this convention, the aorta is considered to occupy an anterior position, while the mouth of the coronary sinus is shown as being posterior. While this nomenclature has served its purpose for the description and treatment of arrhythmias dependent on accessory pathways and atrioventricular nodal re-entry, it is less than satisfactory for the description of atrial and ventricular mapping. To correct these deficiencies, a consensus document has been prepared by experts from the Working Group of Arrhythmias of the European Society of Cardiology, and the North American Society of Pacing and Electrophysiology. It proposes a new, anatomically sound, nomenclature that will be applicable to all chambers of the heart. In this report, we discuss its value as regards the description of the atrioventricular junctions, establishing the principles of this new nomenclature.

Atrioventricular Node↗

The consensus statements on adjuvant chemotherapy in breast cancer. Fact or artifact.

The decision of the National Cancer Institute, in November of 1985, in favor of adjuvant chemotherapy in the treatment of the premenopausal patient was based on the analysis of randomized clinical trials. The authors have carefully evaluated five papers dealing with the trials and found in each of them some problem in the performance or statistics which makes us question the interpretation of the findings of a statistically significant advantage for adjuvant chemotherapy in premenopausal patients. In view of this, we suggest that all the studies being considered need to be checked for their validity and if a significant number have similar flaws to those in the five trials noted, then we suggest that it is not possible to come to conclusions reported by the consensus panel.

Antineoplastic Combined Chemotherapy Protocols↗

Practice guidelines for nutrition care by dietetics practitioners for outpatients with non-insulin-dependent diabetes mellitus: consensus statement.

In summary, nutrition practice guidelines for dietitians who provide outpatient care for persons with NIDDM provide a roadmap for nutrition care that allows for consistency in individualized care. A field test that compares care according to practice guidelines with usual or basic care can provide evidence, based on medical, education/behavior, and cost outcomes, that practice guidelines are not only reasonable and realistic but also effective.

Ambulatory Care↗

[Evidence-based use of methotrexate in children with rheumatic disorders. Consensus statement of the Working Group for Children and Adolescents with Rheumatic Diseases in Germany (AGKJR) and the Working Group Pediatric Rheumatology Austria].

Juvenile idiopathic arthritis (JIA) is the most common diagnosis in children and adolescents with rheumatic disorders. In many children and adolescents, JIA is successfully treated with nonsteroidal antiinflammatory drugs (NSAR) and physiotherapy. Still, in a significant number of cases the disease is resistant to this therapy and treatment with "second line" disease modifying antirheumatic drugs (DMARDs) is required. Methotrexate (MTX) is frequently referred to as "first choice second line agent" for the treatment of JIA. However, there are considerable differences among pediatric rheumatologists on how and when to use MTX. To increase drug safety, the Working Group for Children and Adolescents with Rheumatic Diseases in Germany (AGKJR) and the Working Group Pediatric Rheumatology Austria have initiated the formulation of evidence-based recommendations. Evidence is based on consensus expert meetings, a MEDLINE search with the key words "Methotrexate" and "juvenile arthritis" limited to age 0-18 years, standard textbooks and review articles, data from the central registry of the German Research Center for Rheumatic Diseases (Deutsches Rheumaforschungszentrum Berlin), experience with MTX in adults with rheumatoid arthritis (RA) and recommendations of the German Society of Rheumatology (DGRh). Based on these data, evidence and recommendations are graded and evidence-based recommendations for the use of MTX in children and adolescents with rheumatic disease are presented.

Adolescent↗

Making mistakes in practice. Developing a consensus statement.

OBJECTIVE: To develop a reference statement for the appropriate management of mistakes in the general practice training environment. METHOD: The setting was a series of focus groups held during workshops with The Royal Australian College of General Practitioners Training Program in the Northern Territory (NT). The participants included NT supervisors and registrars, and representatives of the Consumer Reference Group, Top End Division of General Practice. RESULTS: A reference statement and mutually agreed list of duties for registrars, their supervisors and patients. CONCLUSION: Mistakes are a part of the practice of medicine and can impact on everyone. An appropriate response and the opportunity to reflect and learn from the experience are important elements in minimising the adverse impact. We recommend that the issue of mistakes be considered a priority in the teaching of medicine.

Consensus Statements as Topic↗

Guidelines for carotid endarterectomy. A multidisciplinary consensus statement from the Ad Hoc Committee, American Heart Association.

BACKGROUND AND PURPOSE: Indications for carotid endarterectomy have engendered considerable debate among experts and have resulted in publication of retrospective reviews, natural history studies, audits of community practice, position papers, expert opinion statements, and finally prospective randomized trials. The American Heart Association assembled a group of experts in a multidisciplinary consensus conference to develop this statement. METHODS: A conference was held July 16-18, 1993, in Park City, Utah, that included recognized experts in neurology, neurosurgery, vascular surgery, and healthcare planning. A program of critical topics was developed, and each expert presented a talk and provided the chairman with a summary statement. From these summary statements a document was developed and edited onsite to achieve consensus before final revision. RESULTS: The first section of this document reviews the natural history, methods of patient evaluation, options for medical management, results of surgical management, data from position statements, and results to date of prospective randomized trials for symptomatic and asymptomatic patients with carotid artery disease. The second section divides 96 potential indications for carotid endarterectomy, based on surgical risk, into four categories: (1) Proven: This is the strongest indication for carotid endarterectomy; data are supported by results of prospective contemporary randomized trials. (2) Acceptable but not proven: a good indication for operation; supported by promising but not scientifically certain data. (3) Uncertain: Data are insufficient to define the risk/benefit ratio. (4) Proven inappropriate: Current data are adequate to show that the risk of surgery outweighs any benefit. CONCLUSIONS: Indications for carotid endarterectomy in symptomatic good-risk patients with a surgeon whose surgical morbidity and mortality rate is less than 6% are as follows. (1) Proven: one or more TIAs in the past 6 months and carotid stenosis > or = 70% or mild stroke within 6 months and a carotid stenosis > or = 70%; (2) acceptable but not proven: TIAs within the past 6 months and a stenosis 50% to 69%, progressive stroke and a stenosis > or = 70%, mild or moderate stroke in the past 6 months and a stenosis 50% to 69%, or carotid endarterectomy ipsilateral to TIAs and a stenosis > or = 70% combined with required coronary artery bypass grafting; (3) uncertain: TIAs with a stenosis < 50%, mild stroke and stenosis < 50%, TIAs with a stenosis < 70% combined with coronary artery bypass grafting, or symptomatic, acute carotid thrombosis; (4) proven inappropriate: moderate stroke with stenosis < 50%, not on aspirin; single TIA, < 50% stenosis, not on aspirin; high-risk patient with multiple TIAs, not on aspirin, stenosis < 50%; high-risk patient, mild or moderate stroke, stenosis < 50%, not on aspirin; global ischemic symptoms with stenosis < 50%; acute dissection, asymptomatic on heparin. Indications for carotid endarterectomy in asymptomatic good-risk patients performed by a surgeon whose surgical morbidity and mortality rate is less than 3% are as follows. (1) Proven: none. As this statement went to press, the National Institute of Neurological Disorders and Stroke issued a clinical advisory stating that the Institute has halted the Asymptomatic Carotid Atherosclerosis Study (ACAS) because of a clear benefit in favor of surgery for patients with carotid stenosis > or = 60% as measured by diameter reduction. When the ACAS report is published, this indication will be recategorized as proven. (2) acceptable but not proven: stenosis > 75% by linear diameter; (3) uncertain: stenosis > 75% in a high-risk patient/surgeon (surgical morbidity and mortality rate > 3%), combined carotid/coronary operations, or ulcerative lesions without hemodynamically significant stenosis; (4) proven inappropriate: operations with a combined stroke morbidity and mortality > 5%.

Arterial Occlusive Diseases↗

Diagnostic work up of arrhythmogenic right ventricular cardiomyopathy by cardiovascular magnetic resonance (CMR). Consensus statement.

Cardiovascular Magnetic Resonance (CMR) has become a widespread diagnostic tool. Since its introduction CMR has been used to image patients with known or suspected arrhythmogenic right ventricular cardiomyopathy (ARVC). Several abnormalities have been found and described by CMR and at present this diagnostic tool is considered very important for the diagnosis. However, the diagnosis of ARVC relies upon the fulfillment of both clinical and functional criteria and CMR can provide several but not all the information useful for the diagnosis. Furthermore, some findings such as evidence of right ventricular epicardial fat once considered a peculiar marker of ARVC, have been shown to possess a low specificity. This document was prepared by representatives of the three Italian official Organizations involved in CMR. Its main scope is to highlight the problems encountered when studying patients with suspected ARVC by CMR, to indicate the basic technical equipment needed, to recommend a proper imaging protocol and to offer a consensus on the main diagnostic features relevant for the diagnosis.

Arrhythmogenic Right Ventricular Dysplasia↗

Pulmonary artery catheterization and clinical outcomes: National Heart, Lung, and Blood Institute and Food and Drug Administration Workshop Report. Consensus Statement.

OBJECTIVE: The efficacy and safety of the pulmonary artery catheter are under scrutiny because of its association with increased morbidity and mortality in observational studies. In response, the National Heart, Lung, and Blood Institute (NHLBI) and the US Food and Drug Administration (FDA) conducted the Pulmonary Artery Catheterization and Clinical Outcomes workshop in Alexandria, Va, on August 25 and 26, 1997, to develop recommendations regarding actions to improve pulmonary artery catheter utility and safety. PARTICIPANTS: The NHLBI and FDA planning task force selected a workshop chairperson, subcommittee chairs, and participants. Approximately 85 participants were selected for their collective expertise in critical care, pulmonary medicine, cardiovascular medicine and surgery, pediatrics, nursing, biostatistics, and medical economics. The meeting was open to industry representatives and other government and lay observers. This workshop was funded by the NHLBI and the FDA's Division of Devices. EVIDENCE: Published reports relating to the efficacy and safety of the pulmonary artery catheter, especially consensus documents developed by professional societies. CONSENSUS PROCESS: The planning task force disseminated materials, held teleconferences, and developed draft position papers prior to the workshop. These were modified during the workshop and thereafter in the course of several teleconferences, and presented to the entire group for final modifications and approval. CONCLUSIONS: A need exists for collaborative education of physicians and nurses in performing, obtaining, and interpreting information from the use of pulmonary artery catheters. This effort should be led by professional societies, in collaboration with federal agencies, with the purpose of developing and disseminating standardized educational programs. Areas given high priority for clinical trials were pulmonary artery catheter use in persistent/refractory congestive heart failure, acute respiratory distress syndrome, severe sepsis and septic shock, and low-risk coronary artery bypass graft surgery. JAMA. 2000;283:2568-2572

Catheterization, Swan-Ganz↗