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PubMed2001

The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials.

To comprehend the results of a randomized controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this article incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Comment. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from 4 stages of a trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, according to each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.

Publishing↗
PubMed1997

Type II diabetes mellitus clinical guidelines at primary health care level. A SEMDSA Consensus Document, 1997, in association with DESSA, ADSA.

OBJECTIVE: To develop effective education and management programmes for all aspects of diagnosis, treatment and prevention of complications of type II diabetes mellitus in the primary care setting. OPTIONS: The approach suggested is intended to be adaptable to both optimal and minimal health care settings and to individual patient differences both in the public and the private sectors. OUTCOMES: Few long-term studies are currently available worldwide comparing patient outcome (In terms of macrovascular morbidity and overall mortality) with the various treatment regimens or the clinical and biochemical targets recommended. As complications cannot be totally prevented with our current state of knowledge and therapeutics, attention must still be focused on secondary and tertiary prevention to slow the progression of complications after they have been detected. EVIDENCE: Working groups of diabetologists, epidemiologists, gynaecologists, primary care physicians, nurse specialist educators, dieticians, podiatrists and patient-interest organisations reviewed and discussed the current scientific knowledge and clinical recommendations as reflected by the latest overseas position and consensus statements on the subject. The format and spirit of the document are based on the 'Guidelines for the management of non-insulin-dependent diabetes in Africa, 1996' and adapted through local clinical experience to the needs and realities of our country at a primary health care level setting. RECOMMENDATIONS: These include details on the provision of information for early detection, effective management and integration of clinical services for type II diabetes into a multidisciplinary chronic (non-communicable) diseases programme within the existing and evolving national health care system, emphasis on lifestyle modification, appropriate education and medication, the prevention and treatment of complications and timely referrals to a higher level of health care, and the concept of the patient charter of rights and responsibilities in the hope of achieving an optimal level of self-management within the constraints of the disease. VALIDATION: Relevant organisations involved in the education and care of people with diabetes were asked to select representatives to participate in the guidelines working group of the National Diabetes Advisory Board (SEMDSA). Draft documents on 12 topics were produced, amended and widely circulated for comments, criticisms, consensus and endorsement. SPONSORS: The consensus conference and the complication and publication of this document were supported by a generous educational grant from Servier Laboratories (SA).

Diabetes Mellitus, Type 2↗
PubMed1991

Words without action? The production, dissemination, and impact of consensus recommendations.

When existing evaluations find little or no evidence of consensus recommendations leading to action, one can justifiably ask why so much of this review was dedicated to analyzing alternative ways of producing such "words without action." There are, however, at least two reasons why consensus recommendations should be produced with care and attention to validity. First, recommendations do sometimes have an impact on behavior as a consequence of mere dissemination activity--the Dutch program, for instance, was more successful than most. This success may occur when the target audience is already particularly receptive to change and the message is timely and delivered by a credible source in a clinically relevant way. Thus, although "such a conjunction of favorable conditions is probably the exception rather than the rule for consensus topics" (46, 240) it does happen. Second, the output from consensus processes is increasingly a potential input to other processes. Consensus recommendations can be used as the criteria for evaluation and appraisal aimed at changing practice behavior, making administrative decisions on resource allocation, or defining research protocols. For instance, quality assurance activities, such as peer assessment, practitioner certification, or utilization review, are actively seeking criteria with which to make judgments and elicit changes in practice to improve the quality of care. Funding agencies are looking for information to help make reimbursement, capital expenditure, or fee-for-service decisions on cessation of insurance for particular procedures or approaches. These uses of the consensus criteria are potentially major and controversial. Therefore, even if dissemination rarely leads to action, consensus processes should still be done carefully and with valid techniques. The use of their recommendations embedded within other activities may well lead to (forced) changes in behavior. On ethical grounds alone, we should be as sure as possible that the behavior changes being implied and encouraged are indeed advisable. For these reasons, the review describes the decision points in the production process for consensus recommendations as a start on the development of a set of recognized standards. The review offers a critical appraisal of the various methodological choices available at each decision point. The seven decision points are selecting a topic, picking the consensus group, providing background preparation, identifying information inputs, choosing a group judgment process, defining the criteria for recommendations, and choosing a report preparation procedure and format. At least two important points emerged from this review. First, the research is often not well enough developed to give clear indications for many of the choices on what is the "best" alternative.(ABSTRACT TRUNCATED AT 400 WORDS)

Canada↗
PubMed2006

Angelman syndrome 2005: updated consensus for diagnostic criteria.

In 1995, a consensus statement was published for the purpose of summarizing the salient clinical features of Angelman syndrome (AS) to assist the clinician in making a timely and accurate diagnosis. Considering the scientific advances made in the last 10 years, it is necessary now to review the validity of the original consensus criteria. As in the original consensus project, the methodology used for this review was to convene a group of scientists and clinicians, with experience in AS, to develop a concise consensus statement, supported by scientific publications where appropriate. It is hoped that this revised consensus document will facilitate further clinical study of individuals with proven AS, and assist in the evaluation of those who appear to have clinical features of AS but have normal laboratory diagnostic testing.

Angelman Syndrome↗
PubMed2001

The revised CONSORT statement for reporting randomized trials: explanation and elaboration.

Overwhelming evidence now indicates that the quality of reporting of randomized, controlled trials (RCTs) is less than optimal. Recent methodologic analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which boast the elimination of systematic error as their primary hallmark. Systematic error in RCTs reflects poor science, and poor science threatens proper ethical standards. A group of scientists and editors developed the CONSORT (Con solidated S tandards o f R eporting T rials) statement to improve the quality of reporting of RCTs. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have adopted the CONSORT statement. The CONSORT statement facilitates critical appraisal and interpretation of RCTs by providing guidance to authors about how to improve the reporting of their trials. This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the CONSORT statement. The meaning and rationale for each checklist item are presented. For most items, at least one published example of good reporting and, where possible, references to relevant empirical studies are provided. Several examples of flow diagrams are included. The CONSORT statement, this explanatory and elaboration document, and the associated Web site ( http://www.consort-statement.org ) should be helpful resources to improve reporting of randomized trials. Throughout the text, terms marked with an asterisk are defined at end of text.

Algorithms↗
PubMedDate not supplied

Acoustic neuroma.

The National Institutes of Health Consensus Development Conference on Acoustic Neuroma brought together neurosurgeons, radiosurgeons, otologists, neurologists, audiologists, otolaryngologists, and other health care professionals as well as the public to reach agreement (1) on defining the clinical types of acoustic neuroma, (2) on which procedures are useful for screening and diagnosis, (3) on the options available for managing the disorder as well as the complications of treatment, and (4) on the key clinical and biological areas for future research. Following 2 days of presentations by experts and discussion by the audience, a consensus panel weighed the evidence and prepared their consensus statement. Among their findings, the panel concluded that (1) the term vestibular schwannoma is preferred over acoustic neuroma as these tumors are composed of Schwann cells and typically involve the vestibular rather than the acoustic division of the 8th cranial nerve; (2) treatment for vestibular schwannoma must be individualized and requires an experienced, well-integrated, multidisciplinary team approach; (3) surgery remains the treatment of choice, but research is needed on the relative benefits and risks of all management options, including pharmaceutical and other alternative medical treatments such as tumor suppressing agents; (4) routine intraoperative monitoring of the facial nerve should be included in surgical therapy for vestibular schwannoma; (5) neurofibromatosis 2 (NF2) should be carefully considered in all patients newly diagnosed with vestibular schwannoma, and, when found, genetic evaluation and counseling should be provided for all relevant family members; and (6) a registry for all patients with vestibular schwannoma, whether undergoing observation or active management, should be established.

Forecasting↗
PubMed1998

Hereditary hemochromatosis: gene discovery and its implications for population-based screening.

OBJECTIVE: To evaluate the role of genetic testing in screening for hereditary hemochromatosis to help guide clinicians, policymakers, and researchers. PARTICIPANTS: An expert panel was convened on March 3, 1997, by the Centers for Disease Control and Prevention (CDC) and the National Human Genome Research Institute (NHGRI), with expertise in epidemiology, genetics, hepatology, iron overload disorders, molecular biology, public health, and the ethical, legal, and social implications surrounding the discovery and use of genetic information. EVIDENCE: The group reviewed evidence regarding the clinical presentation, natural history, and genetics of hemochromatosis, including current data on the candidate gene for hemochromatosis (HFE) and on the ethical and health policy implications of genetic testing for this disorder. CONSENSUS PROCESS: Consensus was achieved by group discussion confirmed by a voice vote. A draft of the consensus statement was prepared by a writing committee and subsequently reviewed and revised by all members of the expert group over a 1-year period. CONCLUSIONS: Genetic testing is not recommended at this time in population-based screening for hereditary hemochromatosis, due to uncertainties about prevalence and penetrance of HFE mutations and the optimal care of asymptomatic people carrying HFE mutations. In addition, use of a genetic screening test raises concerns regarding possible stigmatization and discrimination. Tests for HFE mutations may play a role in confirming the diagnosis of hereditary hemochromatosis in persons with elevated serum iron measures, but even this use is limited by uncertainty about genotype-phenotype correlations. To address these questions, the expert group accorded high priority to population-based research to define the prevalence of HFE mutations, age and sex-related penetrance of different HFE genotypes, interactions between HFE genotypes and environmental modifiers, and psychosocial outcomes of genetic screening for hemochromatosis.

Female↗
PubMed2002

The first international consensus on mucous membrane pemphigoid: definition, diagnostic criteria, pathogenic factors, medical treatment, and prognostic indicators.

OBJECTIVE: We aimed to develop consensus-based recommendations for streamlining medical communication among various health care professionals, to improve accuracy of diagnosis and treatment, and to facilitate future investigations for mucous membrane pemphigoid. PARTICIPANTS: Because of the highly specific nature of this group of diseases, the 26 invited participants included either international scholars in the field of mucous membrane pemphigoid or experts in cutaneous pharmacology representing the 3 medical disciplines ophthalmology, oral medicine, and dermatology. EVIDENCE: The first author (L.S.C.) conducted a literature search. Based on the information obtained, international experts who had contributed to the literature in the clinical care, diagnosis, and laboratory investigation for mucous membrane pemphigoid were invited to participate in a consensus meeting aimed at developing a consensus statement. CONSENSUS PROCESS: A consensus meeting was convened and conducted on May 10, 1999, in Chicago, Ill, to discuss the relevant issues. The first author drafted the statement based on the consensus developed at the meeting and the participants' written comments. The draft was submitted to all participants for 3 separate rounds of review, and disagreements were reconciled based on literature evidence. The third and final statement incorporated all relevant evidence obtained in the literature search and the consensus developed by the participants. The final statement was approved and endorsed by all 26 participants. CONCLUSIONS: Specific consensus-based recommendations were made regarding the definition, diagnostic criteria, pathogenic factors, medical treatment, and prognostic indicators for mucous membrane pemphigoid. A system of standard reporting for these patients was proposed to facilitate a uniform data collection.

Humans↗
PubMed1989

Do practice guidelines guide practice? The effect of a consensus statement on the practice of physicians.

Guidelines for medical practice can contribute to improved care only if they succeed in moving actual practice closer to the behaviors the guidelines recommend. To assess the effect of such guidelines, we surveyed hospitals and obstetricians in Ontario before and after the release of a widely distributed and nationally endorsed consensus statement recommending decreases in the use of cesarean sections. These surveys, along with discharge data from hospitals reflecting actual practice, revealed that most obstetricians (87 to 94 percent) were aware of the guidelines and that most (82.5 to 85 percent) agreed with them. Attitudes toward the use of cesarean section were congruent with the recommendations even before their release. One third of the hospitals and obstetricians reported changing their practice as a consequence of the guidelines, and obstetricians reported rates of cesarean section in women with a previous cesarean section that were significantly reduced, in keeping with the recommendations (from 72.2 percent to 61.1 percent; P less than 0.01). The surveys also showed, however, that knowledge of the content of the recommendations was poor (67 percent correct responses). Furthermore, data on actual practice after the publication of the guidelines showed that the rates of cesarean section were 15 to 49 percent higher than the rates reported by obstetricians, and they showed only a slight change from the previous upward trend. We conclude that guidelines for practice may predispose physicians to consider changing their behavior, but that unless there are other incentives or the removal of disincentives, guidelines may be unlikely to effect rapid change in actual practice. We believe that incentives should operate at the local level, although they may include system-wide economic changes.

Cesarean Section↗
PubMed1998

Harmony and consensus: cultural aspects of organization in international science.

This article is the beginning of an analysis of cultural processes involved in scientific social organization and change which focuses on the International Working Group for the Harmonization of Dementia Drug Testing Guidelines (IWG). We provide some background for the IWG and for the study of its processes and focus on the construction of consensus and consensus statements of the constituent working groups of the IWG. We delineate a cultural ethos of cooperation that pushes scientists to agree even when they do not and to conceal disagreements. Our observations suggest that the consensus process may serve to inhibit or block the development of new ideas and solutions to problems by keeping conflicts hidden and different viewpoints masked. The masked ideas, although minority ideas, may contain much of importance for subsequent paradigm shifts in approaches to Alzheimer disease and other dementias. In subsequent reports, we will chronicle other aspects of the work of the IWG, including the nature of cross-cultural differences in the drug research structures and processes, governmental regulatory bodies, and the relationship of the pharmaceutical industry to clinical trials research. The present article adds some understanding of the IWG and its mission and contributes to the literature on the cultural construction and social organization of science.

Aged↗
PubMed2001

Guidelines for diagnosis and therapy of MEN type 1 and type 2.

This is a consensus statement from an international group, mostly of clinical endocrinologists. MEN1 and MEN2 are hereditary cancer syndromes. The commonest tumors secrete PTH or gastrin in MEN1, and calcitonin or catecholamines in MEN2. Management strategies improved after the discoveries of their genes. MEN1 has no clear syndromic variants. Tumor monitoring in MEN1 carriers includes biochemical tests yearly and imaging tests less often. Neck surgery includes subtotal or total parathyroidectomy, parathyroid cryopreservation, and thymectomy. Proton pump inhibitors or somatostatin analogs are the main management for oversecretion of entero-pancreatic hormones, except insulin. The roles for surgery of most entero-pancreatic tumors present several controversies: exclusion of most operations on gastrinomas and indications for surgery on other tumors. Each MEN1 family probably has an inactivating MEN1 germline mutation. Testing for a germline MEN1 mutation gives useful information, but rarely mandates an intervention. The most distinctive MEN2 variants are MEN2A, MEN2B, and familial medullary thyroid cancer (MTC). They vary in aggressiveness of MTC and spectrum of disturbed organs. Mortality in MEN2 is greater from MTC than from pheochromocytoma. Thyroidectomy, during childhood if possible, is the goal in all MEN2 carriers to prevent or cure MTC. Each MEN2 index case probably has an activating germline RET mutation. RET testing has replaced calcitonin testing to diagnose the MEN2 carrier state. The specific RET codon mutation correlates with the MEN2 syndromic variant, the age of onset of MTC, and the aggressiveness of MTC; consequently, that mutation should guide major management decisions, such as whether and when to perform thyroidectomy.

Humans↗
PubMed2005

Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2005 update.

BACKGROUND/AIMS: A large amount of new data on the treatment of chronic hepatitis B has become available such that the 2003 consensus statement requires revision and update. METHODS: New data were presented, discussed and debated in an expert pre-meeting to draft a revision. The revised contents were finalized after discussion in a general meeting of APASL. RESULTS: Conceptual background, including the efficacy and safety profile of currently available and emerging drugs, was reviewed. Nineteen recommendations were formed and unresolved issues and areas for further study were suggested. CONCLUSION: The current therapy of chronic hepatitis B is modestly effective but not satisfactory. The development of new drugs and new strategies is required to further improve the outcomes of treatment.

Antiviral Agents↗
PubMed1999

ESCWGA/NASPE/P experts consensus statement: living anatomy of the atrioventricular junctions. A guide to electrophysiologic mapping. Working Group of Arrhythmias of the European Society of Cardiology. North American Society of Pacing and Electrophysiology.

Current nomenclature for the AV junctions derives from a surgically distorted view, placing the valvar rings and the triangle of Koch in a single plane with anteroposterior and right-left lateral coordinates. Within this convention, the aorta is considered to occupy an anterior position, whereas the mouth of the coronary sinus is shown as being posterior. Although this nomenclature has served its purpose for the description and treatment of arrhythmias dependent on accessory pathways and AV nodal reentry, 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 from 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 for description of the AV junctions and establish the principles of this new nomenclature.

Atrioventricular Node↗
PubMed2003

Immunonutrition in the intensive care unit. A systematic review and consensus statement.

OBJECTIVE: To systematically review the effects of enteral nutrition with pharmaconutrients-enriched diets in critically ill patients and to establish recommendations for their use. DATA SOURCES: Computerized bibliographic search of published research and citation review of relevant articles. STUDY SELECTION: Randomized clinical trials of critically ill patients treated with enteral nutrition comparing diets enriched with pharmaconutrients vs not enriched diets were included. Infectious complications and outcome variables (days on mechanical ventilation, ICU and hospital length of stay and mortality) were evaluated. Studies were classified in four subgroups according to the patient's primary diagnosis: surgical, trauma, burned or medical. DATA EXTRACTION: A group of experts in methodology performed data extraction and statistical processes. A global analysis of the studies was done and also a separate study for each subgroup. Results of the meta-analysis were discussed within a 'clinical group' of clinicians with experience in the nutritional support of ICU patients, in order to find agreement about recommendations for the use of pharmaconutrients-enriched diets in critically ill patients. RESULTS: Independent review of 267 articles identified 26 relevant primary studies. Global results indicate that there was a reduction in infection rate in the pharmaconutrition group, considering the appreciated lower incidence in abdominal abscesses (OR: 0.26, CI: 0.12-0.55) (P=0.005), nosocomial pneumonia (OR: 0.54, CI: 0.35-0.84) (P=0.007) and bacteremia (OR: 0.45, CI: 0.35-0.84) (P=0.0002). Also, patients treated with pharmaconutrition diets have a reduction in time on mechanical ventilation (mean 2.25 days, CI: 0.5-3.9) (P=0.009), ICU length of stay (mean reduction of 1.6 days, CI: 1.9-1.2) (P<0.0001) and hospital length of stay (mean reduction of 3.4 days, CI: 4.0-2.7) (P<0.0001). No effects were appreciated on mortality (OR: 1.10, CI: 0.85-1.42) (P=0.5). Nevertheless, the separate analysis for each subgroup showed that the reported beneficial effects were not the same for each patient population. Also, the clinician panel of experts identifies several problems in the published data about enteral pharmaconutrition in critically ill patients. In spite of the subgroup differences and of the problems detected, the clinician group considered that the appreciated results could support a Grade B recommendation for the use of these formulas in ICU patients. CONCLUSIONS: Considering the beneficial effects and the absence of detrimental ones, the use of diets enriched with pharmaconutrients could be recommended in ICU patients requiring enteral feeding. Nevertheless, more investigation is needed in this field in order to find the more appropriate population of patients that can benefit from this nutritional therapy.

Critical Care↗
PubMed1999

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↗