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Controversy in clinical endocrinology: problems with reclassification of insulin-like growth factor I production and action disorders.

CONTEXT: Recent developments in the IGF field have raised questions on whether this is the right time to redefine IGF deficiency. OBJECTIVE: In this controversy, arguments are made against the need for redefining IGF deficiency at this moment, suggesting instead to wait for further clinical developments. CASE: Although a number of rare case reports of IGF deficiency with precise molecular etiologies have been described, the vast majority of the cases remain clinically defined and without a genetic diagnosis. INTERVENTIONS: Because IGF products are now available for clinical use in IGF-deficient patients, we are still using GH stimulation and static IGF levels as our only clinical diagnostic and classification tools. POSITIONS: We need to develop additional clinical tools, side by side with molecular tools, for the diagnosis and subclassification of IGF deficiency. Chief among these are the IGF-generation test for identification of GH-insensitive patients and genetic panels of polymorphic changes in relevant genes. CONCLUSIONS: Until further progress is made in the clinical classification of IGF deficiency, we should not change the current classification, and, when we do, it should be the responsibility of the relevant societies in the field to conduct a consensus statement on the topic first.

Consensus↗

A consensus process on management of major burns accidents: lessons learned from the café fire in Volendam, The Netherlands.

PURPOSE: The optimum response to the different stages of a major burns incident is still not established. The fire in a café in Volendam on New Year's Eve 2000 was the worst incident in recent Dutch history and resulted in mass burn casualties. The fire has been the subject of several investigations concerned with organisational and medical aspects. Based on the findings in these investigations, a multidisciplinary research group started a consensus study. The aim of this study was to further identify areas of improvement in the care after mass burns incidents. DESIGN/METHODOLOGY/APPROACH: The consensus process comprised three postal rounds (Delphi Method) and a consensus conference (modified nominal group technique). The multidisciplinary panel consisted of 26 Dutch-speaking experts, working in influential positions within the sphere of disaster management and healthcare. FINDINGS: In response to the postal questionnaires, consensus was reached for 66 per cent of the statements. Six topics were subsequently discussed during the consensus conference; three topics were discussed within the plenary session and three during subgroup meetings. During the conference, consensus was reached for seven statements (one subject generated two statements). In total, the panel agreed on 21 statements. These covered the following topics: registration and evaluation of disaster care, capacity planning for disasters, pre hospital care of victims of burns disasters, treatment and transportation priorities, distribution of casualties (including interhospital transports), diagnosis and treatment and education and training. ORIGINALITY/VALUE: In disaster medicine, the paper shows how a consensus process is a suitable tool to identify areas of improvement of care after mass burns incidents.

Adult↗

Approaching a consensus cognitive battery for clinical trials in schizophrenia: the NIMH-MATRICS conference to select cognitive domains and test criteria.

To stimulate the development of new drugs for the cognitive deficits of schizophrenia, the National Institute of Mental Health (NIMH) established the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) initiative. This article presents an overview of decisions from the first MATRICS consensus conference. The goals of the meeting were to 1) identify the cognitive domains that should be represented in a consensus cognitive battery and 2) prioritize key criteria for selection of tests for the battery. Seven cognitive domains were selected based on a review of the literature and input from experts: working memory, attention/vigilance, verbal learning and memory, visual learning and memory, reasoning and problem solving, speed of processing, and social cognition. Based on discussions at this meeting, five criteria were considered essential for test selection: good test-retest reliability, high utility as a repeated measure, relationship to functional outcome, potential response to pharmacologic agents, and practicality/tolerability. The results from this meeting constitute the initial steps for reaching a consensus cognitive battery for clinical trials in schizophrenia.

Clinical Trials as Topic↗

Practices to improve antimicrobial use at 47 US hospitals: the status of the 1997 SHEA/IDSA position paper recommendations. Society for Healthcare Epidemiology of America/Infectious Diseases Society of America.

OBJECTIVE: To determine the status of programs to improve antimicrobial prescribing at select US hospitals. DESIGN: Cross-sectional survey. PARTICIPANTS AND SETTING: Pharmacy and infection control staff at all 47 hospitals participating in phase 3 of Project Intensive Care Antimicrobial Resistance Epidemiology. RESULTS: All 47 hospitals had some programs to improve antimicrobial use, but the practices reported varied considerably. All used a formulary, and 43 (91%) used it in conjunction with at least one of the other three antimicrobial-use policies evaluated: stop orders, restriction, and criteria-based clinical practice guidelines (CPGs). CPGs were reported most commonly (70%), followed by stop orders (60%) and restriction policies (40%). Although consultation with an infectious disease physician (70%) or pharmacist (66%) was commonly used to influence initial antimicrobial choice, few (40%) reported a system to measure compliance with these consultations. CONCLUSIONS: In most hospitals surveyed, practices to improve antimicrobial use, although present, were inadequate based on recommendations in a Society for Healthcare Epidemiology of America and Infectious Disease Society of America joint position paper. There is room to improve antimicrobial-use stewardship at US hospitals.

Anti-Bacterial Agents↗

Guidelines for the design and conduct of clinical trials on dentine hypersensitivity.

Clinical trials on dentine hypersensitivity have been numerous and protocols varied. To date there is little consensus as to the conduct of studies on this poorly-understood yet common and painful dental condition. A committee of interested persons from academia and industry was convened to discuss the subject of clinical trials on dentine hypersensitivity and a consensus report is presented. A double-blind randomized parallel groups design is recommended, although cross-over designs may be used for the preliminary screening of agents. Subjects may have multiple sites scored. Sample size will be determined by estimating the variability in the study population, the effect to be detected and the power of the statistical test to be used. Subject selection is based on a clinical diagnosis of dentine hypersensitivity, excluding those with conflicting characteristics such as currently-active medical or dental therapy. The vestibular surfaces of incisors, cuspids and bicuspids are preferred as sites to be tested. A range of sensitivity levels should be included. Tactile, cold and evaporative air stimuli should be applied. Negative and benchmark controls should be incorporated. Most trials should last 8 weeks. Sensitivity may be assessed either in terms of the stimulus intensity required to evoke pain or the subjective evaluation of pain produced by a stimulus using a visual analog or other appropriate scale. The subject's overall assessment may be determined by questionnaire. Outcomes should be expressed in terms of clinically significant changes in symptoms. Follow-up evaluation is required to determine the persistence of changes. At least 2 independent trials should be conducted before a product receives approval.

Air↗

On the difficulties of establishing a consensus on the definition of and diagnostic investigations for reactive arthritis. Results and discussion of a questionnaire prepared for the 4th International Workshop on Reactive Arthritis, Berlin, Germany, July 3-6, 1999.

OBJECTIVE: There is no agreement on how to classify and diagnose reactive arthritis (ReA) and it is also unclear what kind of specific clinical and laboratory investigations are appropriate. We define relevant points of agreement and identify points of disagreement among an international group of experts in the field. METHODS: Prior to the 4th International Workshop on Reactive Arthritis, Berlin, July 1999, we sent questionnaires to 42 experts identified by personal knowledge and recent publications. RESULTS: The response rate was 81% (n = 34). There was agreement on the nomenclature and recommendation to use the term "reactive arthritis" only if the clinical picture and the microbes involved are HLA-B27 and spondyloarthropathy (SpA) associated, whereas the term "infection related arthritis" is used for all other arthritides related to or associated with infections. A differentiation between acute and chronic ReA with a cutoff of 6 months is recommended. The history of a preceding symptomatic infection is thought to be most relevant for a diagnosis of ReA. The minimal interval between preceding symptoms and arthritis is proposed to be 1-7 days, maximally 4 weeks. The joint pattern in ReA is asymmetrical, with predominance of the lower limbs. SpA related symptoms may contribute to the diagnosis. A search for chlamydia in urine/urethra/cervix is recommended, while in the case of diarrhea enterobacteria should be searched for in stool and antibodies against them in serum. There were also areas of disagreement, such as: Is arthritis essential for the diagnosis of ReA?, Is it oligoarthritis or any arthritis?, What are the role and value of polymerase chain reaction investigation?, The role and value of serology?, Is the diagnostic sensitivity of microbiological tests for ReA increased by HLA-B27 determination? CONCLUSION: The points of agreement will support better communication in this area, and clarification of the disagreements will lead to further studies and discussion.

Arthritis, Reactive↗

Concept of and preliminary trial protocol for adjuvant treatment of mediastinitis with immunoglobulins after cardiac surgery (ATMI): response to comments and criticism.

During the consensus-based process of protocol development external experts were invited to comment on a proposal for a trial protocol on adjuvant immunotreatment of patients with wound infection after median sternotomy (ATMI). Controversies and arguments can be divided into five main areas: 1) rationale and objectives; 2) criteria for patient selection; 3) adjuvant treatment; 4) measures of efficacy; and 5) course and timetable of the study. We present and summarise the experts comments and criticism as well as the result of the final discussion of the study group with respect to these areas.

APACHE↗