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National Institutes of Health Consensus Development Conference Statement. Ovarian cancer: screening, treatment, and follow-up.

The National Institutes of Health Consensus Development Conference on Ovarian Cancer-Screening, Treatment, and Follow-up brought together epidemiologists; obstetrician/gynecologists; gynecologic, medical, and radiation oncologists; and the public to address the following questions: (1) What is the current status of screening and prevention in ovarian cancer? (2) What is the appropriate management of early-stage ovarian cancer? (3) What is the appropriate management of advanced epithelial ovarian cancer? (4) What is the appropriate follow-up after primary therapy? and (5) What are the directions for future research? The consensus panel concluded that there is no evidence available as yet that the current screening modalities of CA 125 and transvaginal ultrasonography can be effectively used for widespread screening to reduce mortality from ovarian cancer nor that their use will result in decreased rather than increased morbidity and mortality. They recommended that further prospective research be done to evaluate this very important issue. Women with stage IA grade 1 and most IB grade 1 ovarian cancer do not require postoperative adjuvant therapy. Many remaining stage I patients do require chemotherapy. Subsets of stage I must be fully defined and ideal treatment must be determined. Women with stages II, III, and IV epithelial ovarian cancer (other than low malignant potential tumors) should receive postoperative chemotherapy. Physicians should be encouraged to discuss clinical trial participation with women, and women should be encouraged to participate. All women should have access to accurate and complete information regarding ovarian cancer. Furthermore, there must be no barriers to women's access to qualified specialists, optimal therapy, and protocols. The full text of the consensus panel's statement follows.

Combined Modality Therapy↗

The role of self-monitoring of blood glucose in the care of people with diabetes: report of a global consensus conference.

Self-monitoring of blood glucose (SMBG) is an underutilized but integral part of disease management for patients with both type 1 and type 2 diabetes. Guidelines on the recommended frequency and timing of SMBG vary among international diabetes associations, and patients are often unaware of actions they should take in response to SMBG. results. In response to this, a global consensus conference of recognized diabetes experts convened to clarify the role of SMBG as a tool to help optimize glycemic control (e.g., complementing information provided by hemoglobin A1c, detecting postprandial excursions, identifying glucose patterns, and providing patients feedback on lifestyle and medications) while minimizing hypoglycemia and maintaining quality of life. The consensus panel also sought to reinforce the importance of appropriate and systematic patient and provider response to the collected SMBG data. A set of 16 consensus statements was approved by the panel. This article presents the 16 statements together with some brief rationale for their inclusion.

Blood Glucose↗

Consensus conferences in critical care medicine. Methodologies and impact.

Consensus conferences for the purposes of producing practice guidelines are occurring with increasing frequency both nationally and internationally. The international collaboration of national sciences in these efforts could have a dramatic impact on international standards of care. Too little emphasis is given to conference evaluations in terms of validity of methods, quality of recommendations, and influence on clinical practice and patient outcome. This article provides an overview of consensus methods used to produce guidelines in critical care. It also discusses the strengths and weaknesses of these methods, and how these may influence consensus guidelines. Finally, a brief overview of theoretically sound methods that can serve as benchmarks to evaluate current methods, and the bases for the development of improved methods is provided.

Consensus Statements as Topic↗

Committees and consensus: how many heads are better than one?

The first section of this paper asks why the notion of consensus has recently come to the fore in the medical humanities, and suggests that the answer is a function of growing technological and professional complexity. The next two sections examine the concept of consensus analytically, citing some of the recent philosophical literature. The fourth section looks at committee deliberations and their desirable outcomes, and questions the degree to which consensus serves those outcomes. In the fifth and last section it is suggested that if I am to subscribe to a consensual outcome responsibly I must be personally committed to it, and that this requires a form of knowledge I call 'fiduciary', in this case knowledge of the competence and trustworthiness of other participants in deliberation whose expertise may have influenced my agreement.

Advisory Committees↗

Asia-Pacific Consensus Statement on dementia.

The 12 national Alzheimer's Associations that contributed to this Consensus Statement will continue to network with one another regionally and will continue to share relevant expertise and practical resources. It is expected that regional consensus on dementia will evolve in individual member countries and in the Asia-Pacific region as a whole. It is the hope of the participating members of these two consensus conferences that this document will provide the inspiration, direction, and practical ideas to further advance the goals of national Alzheimer's Associations and to further advance dementia-related medical and service activities within the Asia-Pacific region.

Aged↗

Depression and bipolar support alliance consensus statement on the unmet needs in diagnosis and treatment of mood disorders in children and adolescents.

OBJECTIVE: To focus attention on the critical unmet needs of children and adolescents with mood disorders and to make recommendations for future research and allocation of healthcare resources. METHOD: The 36-member Consensus Development Panel consisted of experts in child/adolescent or adult psychiatry and psychology, pediatrics, and mental health advocacy. Reviews of the literature concerning youth mood disorders were performed on the subjects of risk factors, prevention, diagnosis, treatment, and services delivery, and opinions and experiences of mental health advocates were obtained. RESULTS: The Consensus Development Panel listened to presentations and participated in discussions. Independent workgroups of clinicians, scientists, and mental health advocates considered the evidence and prepared preliminary statements. Workgroup leaders presented drafts for discussion by the Consensus Development Panel. The final document was reviewed by the entire group and edited to incorporate input from all participants. CONCLUSIONS: Evidence suggests high rates of unmet needs for children and adolescents with depression or bipolar disorder. Training is largely limited to child mental health specialists; general psychiatrists, pediatricians, and other primary care physicians receive little or no training. As a result, treatment patterns may reflect adult treatment plans that are not validated for youths. Effective treatments have been identified and some preliminary prevention models have been developed, but they are not yet widely applied. Patients experience limited exposure to clinicians adequately trained to address their problems and little information to guide care decisions, particularly concerning bipolar disorder. National efforts are required to restructure healthcare delivery and provider training and to immediately develop more advanced research on pathophysiology, prevention, and services delivery effectiveness.

Adolescent↗

An evidence-based, Latin-American consensus on gastro-oesophageal reflux disease.

In recognition of the high prevalence of gastro-oesophageal reflux disease (GORD) and its importance in Latin America, the InterAmerican Association of Gastroenterology and the InterAmerican Society of Digestive Endoscopy organized a Latin-American Consensus on GORD in Cancun, Mexico in September 2004. The main objectives of the consensus meeting were to provide evidence-based guidance with respect to the diagnosis and treatment of GORD, relevant to all countries in the region. The methodology, results and recommendations of the consensus are described in detail.

Adult↗

The international sepsis forum consensus conference on definitions of infection in the intensive care unit.

OBJECTIVE: To develop definitions of infection that can be used in clinical trials in patients with sepsis. CONTEXT: Infection is a key component of the definition of sepsis, yet there is currently no agreement on the definitions that should be used to identify specific infections in patients with sepsis. Agreeing on a set of valid definitions that can be easily implemented as part of a clinical trial protocol would facilitate patient selection, help classify patients into prospectively defined infection categories, and therefore greatly reduce variability between treatment groups. DESIGN AND METHODS: Experts in infectious diseases, clinical microbiology, and critical care medicine were recruited and allocated specific infection sites. They carried out a systematic literature review and used this, and their own experience, to prepare a draft definition. At a subsequent consensus conference, rapporteurs presented the draft definitions, and these were then refined and improved during discussion. Modifications were circulated electronically and subsequently agreed upon as part of an iterative process until consensus was reached. RESULT: Consensus definitions of infection were developed for the six most frequent causes of infections in septic patients: pneumonia, bloodstream infections (including infective endocarditis), intravascular catheter-related sepsis, intra-abdominal infections, urosepsis, and surgical wound infections. CONCLUSIONS: We have described standardized definitions of the common sites of infection associated with sepsis in critically ill patients. Use of these definitions in clinical trials should help improve the quality of clinical research in this field.

Clinical Trials as Topic↗

International pediatric sepsis consensus conference: definitions for sepsis and organ dysfunction in pediatrics.

OBJECTIVE: Although general definitions of the sepsis continuum have been published for adults, no such work has been done for the pediatric population. Physiologic and laboratory variables used to define the systemic inflammatory response syndrome (SIRS) and organ dysfunction require modification for the developmental stages of children. An international panel of 20 experts in sepsis and clinical research from five countries (Canada, France, Netherlands, United Kingdom, and United States) was convened to modify the published adult consensus definitions of infection, sepsis, severe sepsis, septic shock, and organ dysfunction for children. DESIGN: Consensus conference. METHODS: This document describes the issues surrounding consensus on four major questions addressed at the meeting: a) How should the pediatric age groups affected by sepsis be delineated? b) What are the specific definitions of pediatric SIRS, infection, sepsis, severe sepsis, and septic shock? c) What are the specific definitions of pediatric organ failure and the validity of pediatric organ failure scores? d) What are the appropriate study populations and study end points required to successfully conduct clinical trials in pediatric sepsis? Five subgroups first met separately and then together to evaluate the following areas: signs and symptoms of sepsis, cell markers, cytokines, microbiological data, and coagulation variables. All conference participants approved the final draft of the proceedings of the meeting. RESULTS: Conference attendees modified the current criteria used to define SIRS and sepsis in adults to incorporate pediatric physiologic variables appropriate for the following subcategories of children: newborn, neonate, infant, child, and adolescent. In addition, the SIRS definition was modified so that either criteria for fever or white blood count had to be met. We also defined various organ dysfunction categories, severe sepsis, and septic shock specifically for children. Although no firm conclusion was made regarding a single appropriate study end point, a novel nonmortality end point, organ failure-free days, was considered optimal for pediatric clinical trials given the relatively low incidence of mortality in pediatric sepsis compared with adult populations. CONCLUSION: We modified the adult SIRS criteria for children. In addition, we revised definitions of severe sepsis and septic shock for the pediatric population. Our goal is for these first-generation pediatric definitions and criteria to facilitate the performance of successful clinical studies in children with sepsis.

Adolescent↗

Consensus on extra-hepatic portal vein obstruction.

The Asian Pacific Association for the Study of the Liver (APASL) had set up a working party on portal hypertension in 2002 with a mandate to develop consensus on various aspects of portal hypertension. The first of these consensuses has been developed on extra-hepatic portal vein obstruction (EHPVO). It was discussed and prepared by the experts in this field from the Asian region and was presented at the annual meeting of the APASL, at Bali in August 2005. This article summarizes all the consensus statements approved by the APASL on various aspects of EHPVO.

Anticoagulants↗

Adult Asthma Consensus Guidelines update 2003.

BACKGROUND: Several sets of Canadian guidelines for the diagnosis and management of asthma have been published over the past 15 years. Since the last revision of the 1999 Canadian Asthma Consensus Report, important new studies have highlighted the need to incorporate new information into the asthma guidelines. OBJECTIVES: To review the literature on adult asthma management published between January 2000 and June 2003; to evaluate the influence of the new evidence on the recommendations made in the 1999 Canadian Asthma Consensus Guidelines and its 2001 update; and to report new recommendations on adult asthma management. METHODS: Three specific topics for which new evidence affected the previous recommendations were selected for review: initial treatment of asthma, add-on therapies in the treatment of asthma and asthma education. The resultant reviews were discussed in June 2003 at a meeting under the auspices of the Canadian Thoracic Society, and recommendations for adult asthma management were reviewed. RESULTS: The present report emphasises the importance of the early introduction of inhaled corticosteroids in symptomatic patients with mild asthma; stresses the benefit of adding additional therapy, preferably long-acting beta2-agonists, to patients incompletely controlled on low doses of inhaled corticosteroids; and documents the essential role of asthma education. CONCLUSION: The present report generally supports many of the previous recommendations published in the 1999 Canadian Asthma Consensus Report and provides higher levels of evidence for a number of those recommendations.

Adrenal Cortex Hormones↗

Canadian Consensus Conference on the management of gastroesophageal reflux disease in adults - update 2004.

BACKGROUND: Gastroesophageal reflux disease (GERD) is the most prevalent acid-related disorder in Canada and is associated with significant impairment of health-related quality of life. Since the last Canadian Consensus Conference in 1996, GERD management has evolved substantially. OBJECTIVE: To develop up-to-date evidence-based recommendations relevant to the needs of Canadian health care providers for the management of the esophageal manifestations of GERD. CONSENSUS PROCESS: A multidisciplinary group of 23 voting participants developed recommendation statements using a Delphi approach; after presentation of relevant data at the meeting, the quality of the evidence, strength of recommendation and level of consensus were graded by participants according to accepted principles. OUTCOMES: GERD applies to individuals who reflux gastric contents into the esophagus causing symptoms sufficient to reduce quality of life, injury or both; endoscopy-negative reflux disease applies to individuals who have GERD and a normal endoscopy. Uninvestigated heartburn-dominant dyspepsia - characterised by heartburn or acid regurgitation - includes erosive esophagitis or endoscopy-negative reflux disease, and may be treated empirically as GERD without further investigation provided there are no alarm features. Lifestyle modifications are ineffective for frequent or severe GERD symptoms; over-the-counter antacids or histamine H2-receptor antagonists are effective for some patients with mild or infrequent GERD symptoms. Proton pump inhibitors are more effective for healing and symptom relief than histamine H2-receptor antagonists; their efficacy is proportional to their ability to reduce intragastric acidity. Response to initial therapy - a once-daily proton pump inhibitor unless symptoms are mild and infrequent (fewer than three times per week) - should be assessed at four to eight weeks. Maintenance medical therapy should be at the lowest dose and frequency necessary to maintain symptom relief; antireflux surgery is an alternative for a small proportion of selected patients. Routine testing for Helicobacter pylori infection is unnecessary before starting GERD therapy. GERD is associated with Barrett's epithelium and esophageal adenocarcinoma but the risk of malignancy is very low. Endoscopic screening for Barrett's epithelium may be considered in adults with GERD symptoms for more than 10 years; Barrett's epithelium and low-grade dysplasia generally warrant surveillance; endoscopic or surgical management should be considered for confirmed high-grade dysplasia or malignancy. CONCLUSION: Prospective studies are needed to investigate clinically relevant risk factors for the development of GERD and its complications; GERD progression, on and off therapy; optimal management strategies for typical GERD symptoms in primary care patients; and optimal management strategies for atypical GERD symptoms, Barrett's epithelium and esophageal adenocarcinoma.

Adult↗

Symptomatic treatment of multiple sclerosis. Multiple Sclerosis Therapy Consensus Group (MSTCG) of the German Multiple Sclerosis Society.

Besides immunomodulation and immunosuppression, the specific treatment of symptoms is an essential component of the overall management of multiple sclerosis (MS). Symptomatic treatment is aimed at the elimination or reduction of symptoms impairing the functional abilities and quality of life of the affected patients. Moreover, with symptomatic treatment the development of a secondary physical impairment due to an existing one may be avoided. Many therapeutic techniques as well as different drugs are used for the treatment of MS symptoms, but only a few of them have been investigated, especially in MS patients, and are approved by the national health authorities. Despite an overwhelming number of publications, only a few evidence-based studies exist and consensus reports are very rare, too. Therefore, it seemed necessary to develop a consensus statement on symptomatic treatment of MS comprising existing evidence-based literature as well as therapeutic experience of neurologists who have dealt with these problems over a long time. This consensus paper contains proposals for the treatment of the most common MS symptoms: disorders of motor function and coordination, of cranial nerve function, of autonomic, cognitive, and psychological functions as well as MS-related pain syndromes and epileptic seizures.

Humans↗

Management of the child born small for gestational age through to adulthood: a consensus statement of the International Societies of Pediatric Endocrinology and the Growth Hormone Research Society.

OBJECTIVE: Low birth weight remains a major cause of morbidity and mortality in early infancy and childhood. It is associated with an increased risk of health problems later in life, particularly coronary heart disease and stroke. A meeting was convened to identify the key health issues facing a child born small for gestational age (SGA) and to propose management strategies. PARTICIPANTS: There were 42 participants chosen for their expertise in obstetrics, peri- and neonatal medicine, pediatrics, pediatric and adult endocrinology, epidemiology, and pharmacology. EVIDENCE: Written materials were exchanged, reviewed, revised, and then made available to all. This formed the basis for discussions at the meeting. Where published data were not available or adequate, discussion was based on expert clinical opinions. CONSENSUS PROCESS: Each set of questions was considered by all and then discussed in plenary sessions with consensus and unresolved issues identified. The consensus statement was prepared in plenary sessions and then edited by the group chairs and shared with all participants. CONCLUSIONS: The diagnosis of SGA should be based on accurate anthropometry at birth including weight, length, and head circumference. We recommend early surveillance in a growth clinic for those without catch-up. Early neurodevelopment evaluation and interventions are warranted in at-risk children. Endocrine and metabolic disturbances in the SGA child are recognized but infrequent. For the 10% who lack catch-up, GH treatment can increase linear growth. Early intervention with GH for those with severe growth retardation (height sd score, <-2.5; age, 2-4 yr) should be considered at a dose of 35-70 microg/kg x d. Long-term surveillance of treated patients is essential. The associations at a population level between low birth weight, including SGA, and coronary heart disease and stroke in later life are recognized, but there is inadequate evidence to recommend routine health surveillance of all adults born SGA outside of normal clinical practice.

Adult↗

Translating findings of systematic reviews into consensus statements on periodontal therapy.

BACKGROUND: The greatest value of the biomedical literature lies not in individual studies, but in the best available evidence within the entire body of evidence. In many fields, including dentistry, systematic reviews, or SRs, have become the preferred method of analyzing and interpreting large amounts of data toward developing clinical practice guidelines. METHODS: The American Academy of Periodontology, or AAP, formulated clinically relevant, focused questions and developed a protocol for SRs. Reviewers systematically searched online databases and print journals and contacted authors, journal editors and industry experts. For each included study, the reviewers determined the level of evidence and summarized the findings. Centralized management of biostatistics provided consistency. At a structured conference, the reviews were the basis for development of consensus reports that included implications for practice and research. RESULTS: The SRs provided comprehensive analyses of the best available clinically relevant evidence in key areas of periodontal practice. The reviews also identified knowledge gaps and suggested direction for future studies. The conference focused on translating the findings from the SRs into general consensus statements that described scientific and clinical assessments and implications for research and practice. CLINICAL IMPLICATIONS: Consensus statements based on SRs are important linchpins of modern dentistry. They aid in the development of appropriate treatment protocols for specific clinical circumstances. These protocols, in turn, help ensure the integration of clinically relevant scientific evidence with the expertise of individual clinicians, along with the unique characteristics, needs and wants of individual patients.

Anti-Bacterial Agents↗

An evidence-based approach to prescribing nonsteroidal antiinflammatory drugs. Third Canadian Consensus Conference.

OBJECTIVE: To revisit our previous evidence-based recommendations on the appropriate prescription of nonsteroidal antiinflammatory drugs (NSAID) with particular emphasis on cyclooxygenase-2 selective inhibitors (coxibs). METHODS: Needs assessments were conducted among Canadian physicians to determine their educational needs surrounding NSAID/coxibs. A survey of patients with arthritis was also conducted. Consensus participants reviewed articles relating to NSAID/coxibs in peer-reviewed journals between January 2000 and December 2004. At the consensus meeting, held January 21-23, 2005, participants discussed selected topics, after which recommendations were formulated and debated. Results. At the time of the meeting, it was agreed that emerging cardiovascular data were not clear enough to decide whether unanticipated cardiovascular events associated with coxibs represent a class effect or an effect of an individual drug. However, publications that appeared shortly after the meeting, as well as data presented at both the Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the US Food and Drug Administration, February 16-18, 2005, and Health Canada's Expert Advisory Panel on the Safety of Cox-2 Selective NSAID, June 9-10, 2005, clarified that all available coxibs do carry some degree of cardiovascular risk, denoting a class effect. Our consensus group made the following specific recommendations: (1) Patients should be fully informed about treatment options, including the need to balance between cardiovascular risks and gastrointestinal (GI) benefits of NSAID/coxibs. (2) Coxibs are as effective as nonselective NSAID and superior to acetaminophen for the symptoms of arthritis. Topical NSAID may also be beneficial. (3) Coxibs are associated with fewer severe GI complications than nonselective NSAID. A proton pump inhibitor (PPI) should be prescribed if an NSAID must be used in a patient at increased GI risk. (4) The renal/blood pressure (BP) impact of coxibs is similar to that of NSAID. (5) In individuals at risk, creatinine clearance and BP should be determined at baseline and shortly after treatment begins. (6) In the geriatric population, use of nonpharmacological therapies should be maximized, and special caution is required before prescribing oral NSAID/coxibs. (7) Patients taking rofecoxib have been shown to have an increased risk of cardiovascular events. Current data suggest that this increased cardiovascular risk may be an effect of the NSAID/coxib class. (8) Although the data are limited, coxibs may be more cost-effective for patients at high GI risk than nonselective NSAID plus proprietary PPI. CONCLUSION: Coxibs continue to be an option in the treatment armamentarium. Given the evolving cardiovascular information, physicians and patients should weigh the benefits and risks of NSAID/coxib treatment. This concern emphasizes the need to routinely reassess patients' risks. These recommendations, which were formulated according to the Appraisal of Guidelines for Research and Evaluation, are intended to be used as guidelines to supplement, but not replace, the physician's judgment in clinical decision-making.

Anti-Inflammatory Agents, Non-Steroidal↗

Optimising antimicrobial prescription in hospitals by introducing an antimicrobial stewardship programme in Hong Kong: consensus statement.

OBJECTIVE: To discuss the implementation of an 'antimicrobial stewardship programme' as a means to improve the quality of antimicrobial use in a hospital setting in Hong Kong. PARTICIPANTS: Consensus working group on 'antimicrobial stewardship programme', The Scientific Committee on Infection Control, Centre for Health Protection, Department of Health, comprised 11 experts. The remit of the working group was to discuss the rationale and requirement for optimising antimicrobial prescriptions in hospitals by the introduction of an 'antimicrobial stewardship programme'. EVIDENCE: PubMed articles, national and international guidelines, and abstracts of international meetings published between January 2000 and December 2004 on programmes for improving the use of antimicrobials in hospitals. Only English medical literature was reviewed. CONSENSUS PROCESS: Data search was performed independently by three members of the working group. They met on three occasions before the meeting to discuss all collected articles. A final draft was circulated to the working group before a meeting on 3 January 2005. Five commonly asked questions about an 'antimicrobial stewardship programme' were selected for discussion by the participants. Published information on the rationale, components, outcome measures, advantages, and disadvantages of the programme was reviewed. Recent unpublished data from local studies of an 'antimicrobial stewardship programme' were also discussed. The timing, potential problems, and practical issues involved in the implementation of an 'antimicrobial stewardship programme' in Hong Kong were then considered. The consensus statement was circulated to and approved by all participants. CONCLUSION: The continuous indiscriminate and excessive use of antimicrobial agents promotes the emergence of antibiotic-resistant organisms. Antimicrobial resistance substantially raises already-rising health care costs and increases patient morbidity and mortality. Pattern of prescriptions in hospitals can be improved through the implementation of an 'antimicrobial stewardship programme'. A 'universal' and 'continuous' 'antimicrobial stewardship programme' should now be established in Hong Kong hospitals.

Anti-Infective Agents↗

Diagnosis and management of asymptomatic primary hyperparathyroidism. National Institutes of Health Consensus Development Conference. October 29-31, 1990.

The National Institutes of Health Consensus Development Conference on Diagnosis and Management of Asymptomatic Primary Hyperparathyroidism brought together endocrinologists, surgeons, radiologists, epidemiologists, and primary health care providers as well as the public to address indications for surgery in asymptomatic patients with hyperparathyroidism (HPT) and how patients not operated on should be monitored and managed to minimize the risk of complications of HPT. Following 1 1/2 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) a diagnosis of HPT is established by demonstrating persistent hypercalcemia together with an elevated serum parathyroid hormone concentration; (2) current and acceptable treatment for HPT is surgery to cure the condition; (3) the diagnosis of HPT in an asymptomatic patient does not in all cases mandate referral for surgery; conscientious surveillance may be justified in patients whose calcium levels are only mildly elevated and whose renal and bone status are close to normal; and (4) preoperative localization in patients without prior neck operation is rarely indicated and not proven to be cost-effective.

Humans↗