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Canadian guidelines for intravenous thrombolytic treatment in acute stroke. A consensus statement of the Canadian Stroke Consortium.

BACKGROUND: The thromobolytic drug, tissue plasminogen activator (tPA) has been approved in the United States for the treatment of acute ischemic stroke amid controversy and concern about the balance of risk and benefit. The Canadian Stroke Consortium (CSC), a national network of neurologists who collaborate on joint projects in stroke medicine, including clinical trials and consensus statements, has developed guidelines for the use of tPA in Canada. METHODS AND RESULTS: The CSC Board of Directors wrote a preliminary report based on existing publications, including randomized drug trials and the report of a special committee struck by the Stroke Council of the American Heart Association. This draft was circulated to the CSC membership-at-large for suggestions or amendments, to produce this final draft. CONCLUSIONS: The present guidelines have been devised to represent a Canadian viewpoint of management. The Health Protection Branch of the Ministry of Health of Canada has not yet produced an evaluation. Further modification of these guidelines may be necessary when more data from clinical trials and experience with the drug become available.

Acute Disease↗

NIH Consensus Statement on Breast Cancer Screening for Women in Their 40s: How Will It Affect Patient Care?

It is generally accepted that breast cancer screening mammograms in women 50 years of age and older has saved lives. It also is generally accepted that the incidence of breast cancer in women younger than 40 is too small to warrant subjecting young women to the risks associated with mammograms. But whether women in the transition years from 40 to 49 should have routine screening mammograms has been debated for 2 decades. On January 23, the NIH Consensus Statement on Screening Mammograms for Women Ages 40 to 49 lit a powder keg when, after 2-and-a-half days of hearings and study, it announced "The data do not support a universal recommendation that all women in their 40s should undergo screening mammography." Many experts have challenged the conclusion and advocated screening mammograms every 1 to 2 years starting at age 40. To sort out the impact of the NIH statement and determine where clinicians and consumers stand, Medscape launched its first on-line survey on January 30. Most Medscape responders agree that screening mammograms every 1 to 2 years should begin at age 40 and fear that third-party health care payers will use the conclusion of the NIH consensus panel to deny reimbursement for screening mammograms in women younger than 50 years of age.

Journal Article↗

Consensus statement: benefits versus risks of medical therapy for acromegaly.

A consensus panel defined the risks and benefits of medical management of acromegaly and determined a place for the use of the somatostatin analogue, octreotide, in the overall management strategy of patients with acromegaly. Octreotide was considered effective in managing acromegaly, and its role as an adjuvant to surgery was defined. Octreotide is beneficial to radiotherapy-treated patients in that the drug suppresses growth hormone (GH) secretion until the long-term effects of radiation occur. Complications associated with octreotide are minor relative to the benefits, but requirements for multiple daily injections and drug cost are drawbacks. Approximately 20% to 30% of octreotide-treated acromegalic patients develop gallstones or sludge, which are usually asymptomatic and require no treatment. Surgery continues to be the principal therapeutic approach for GH-secreting pituitary tumors, and improved octreotide delivery methods and second-generation analogues will provide further advantages for pharmacotherapy.

Acromegaly↗

Maternal and neonatal outcome of patients classified according to the Australasian Society for the Study of Hypertension in Pregnancy Consensus Statement.

OBJECTIVE: To outline the maternal and perinatal features and outcome of patients referred to a tertiary referral obstetric hospital for management of their hypertension. SETTING AND PATIENTS: 205 consecutive public patients admitted for assessment of hypertension (either full admission or day-stay) to King George V Hospital's Hypertension in Pregnancy Unit, between February 1993 and January 1994. DESIGN: A prospective study in which patients were classified according to the Australasian Society for the Study of Hypertension in Pregnancy (ASSHP) Consensus Statement classification. RESULTS: Of the 205 patients, 25% did not meet the criteria for pre-eclampsia or chronic hypertension, 33% had mild pre-eclampsia, 34% had severe pre-eclampsia and the remainder had chronic hypertension. The mean gestation at delivery for those with mild pre-eclampsia was 38.3 weeks and for severe pre-eclampsia 35.3 weeks. For the mild and severe groups respectively, the rate of elective delivery for raised blood pressure was 56% and 53%; for caesarean section, 17% and 61%; and for perinatal death, 2% and 4%. In the severe group, 49% had fetal problems and 25% required intravenous antihypertensives. CONCLUSIONS: The multisystem nature of pre-eclampsia makes comparison of management protocols difficult. Ongoing audit is needed of maternal and perinatal outcomes and features of disease in patients with hypertension in pregnancy under a universal classification. The ASSHP classification system successfully identifies patients who require more intensive management and intervention.

Chronic Disease↗

Consensus statement: Palliative and supportive care in advanced heart failure.

BACKGROUND: A consensus conference was convened to define the current state and important gaps in knowledge and needed research on "Palliative and Supportive Care in Advanced Heart Failure." EVIDENCE: Evidence was drawn from expert opinion and from extensive review of the medical literature, evidence-based guidelines, and reviews. CONCLUSIONS: The conference identified gaps in current knowledge, practice, and research relating to prognostication, symptom management, and supportive care for advanced heart failure (HF). Specific conclusions include: (1) although supportive care should be integrated throughout treatment of patients with advanced HF, data are needed to understand how to best decrease physical and psychosocial burdens of advanced HF and to meet patient and family needs; (2) prognostication in advanced HF is difficult and data are needed to understand which patients will benefit from which interventions and how best to counsel patients with advanced HF; (3) research is needed to identify which interventions improve quality of life and best achieve the outcomes desired by patients and family members; (4) care should be coordinated between sites of care, and barriers to evidence-based practice must be addressed programmatically; and (5) more research is needed to identify the content and technique of communicating prognosis and treatment options with patients with advanced HF; physicians caring for patients with advanced HF must develop skills to better integrate the patient's preferences into the goals of care.

Counseling↗

NIH Consensus statement. Bioelectrical impedance analysis in body composition measurement. National Institutes of Health Technology Assessment Conference Statement. December 12-14, 1994.

OBJECTIVE: To provide physicians with a responsible assessment of bioelectrical impedance analysis (BIA) technology for body composition measurement. PARTICIPANTS: A non-Federal, nonadvocate, 13-member panel representing the fields of nutrition, pediatrics, surgery, public health, biomedical engineering, epidemiology, and biostatistics. In addition, 20 experts in nutrition, pediatrics, metabolism, biomedical engineering, physiology, and epidemiology presented data to the panel and a conference audience of 220. EVIDENCE: The literature was searched through Medline and an extensive bibliography of reference was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. ASSESSMENT PROCESS: The panel, answering predefined questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. The panel composed a draft statement that was read in its entirety and circulated to the experts and the audience for comment. Thereafter, the panel resolved conflicting recommendations and released a revised statement at the end of the conference. The panel finalized the revisions within a few weeks after conference. CONCLUSIONS: BIA provides a reliable estimate of total body water under most conditions. It can be a useful technique for body composition analysis in healthy individuals and in those with a number of chronic conditions such as mild-to-moderate obesity, diabetes mellitus, and other medical conditions in which major disturbances of water distribution are not prominent. BIA values are affected by numerous variables including body position, hydration status, consumption of food and beverages, ambient air and skin temperature, recent physical activity, and conductance of the examining table. Reliable BIA requires standardization and control of these variables. A specific, well-defined procedure for performing routine BIA measurements is not practiced. Therefore, the panel recommends that a committee of appropriate scientific experts and instruments manufacturers be formed with the goal of setting instruments standards and procedural methods.

Adipose Tissue↗

Consensus statement on injury definitions and data collection procedures in studies of football (soccer) injuries.

Variations in definitions and methodologies have created differences in the results and conclusions obtained from studies of football injuries; this has made inter-study comparisons difficult. An Injury Consensus Group was established under the auspices of FIFA Medical Assessment and Research Centre. Using a nominal group consensus model approach, a working document that identified the key issues related to definitions, methodology and implementation was discussed by members of the group during a 2-day meeting. Following this meeting, iterative draft statements were prepared and circulated to members of the group for comment before the final consensus statement was produced. Definitions of injury, recurrent injury, severity and training and match exposures in football together with criteria for classifying injuries in terms of location, type, diagnosis and causation are proposed. Proforma for recording players' baseline information, injuries and training and match exposures are presented. Recommendations are made on how the incidence of match and training injuries should be reported and a checklist of issues and information that should be included in published reports of studies of football injuries is presented. The definitions and methodology proposed in the consensus statement will ensure that consistent and comparable results will be obtained from studies of football injuries.

Athletic Injuries↗

Consensus statement on injury definitions and data collection procedures in studies of football (soccer) injuries.

BACKGROUND: Variations in definitions and methodologies have created differences in the results and conclusions obtained from studies of football (soccer) injuries; this has made interstudy comparisons difficult. PROCEDURE: An Injury Consensus Group was established under the auspices of Fédération Internationale de Football Association Medical Assessment and Research Centre. Using a nominal group consensus model approach, a working document that identified the key issues related to definitions, methodology, and implementation was discussed by members of the group during a 2-day meeting. After this meeting, iterative draft statements were prepared and circulated to the members of the group for comment before the final consensus statement was produced. RESULTS: Definitions of injury, recurrent injury, severity, and training and match exposures in football, together with criteria for classifying injuries in terms of location, type, diagnosis, and causation are proposed. Proforma for recording players' baseline information, injuries, and training and match exposures are presented. Recommendations are made on how the incidence of match and training injuries should be reported and a checklist of issues and information that should be included in published reports of studies of football injuries is presented. CONCLUSIONS: The definitions and methodology proposed in the consensus statement will ensure that consistent and comparable results will be obtained from studies of football injuries.

Athletic Injuries↗

NIH Consensus Statement on Management of Hepatitis C: 2002.

OBJECTIVE: To provide health care providers, patients, and the general public with a responsible assessment of currently available data regarding the management and treatment of hepatitis C. PARTICIPANTS: A non-Federal, nonadvocate, 12-member panel representing the fields of infectious diseases, gastroenterology, medical oncology, molecular genetics, geriatrics, internal medicine, and the public. In addition, experts in these same fields presented data to the panel and to a conference audience of approximately 300. EVIDENCE: Presentations by experts; a systematic review of the medical literature provided by the Agency for Healthcare Research and Quality; and an extensive bibliography of hepatitis C research papers, prepared by the National Library of Medicine. Scientific evidence was given precedence over clinical anecdotal experience. CONFERENCE PROCESS: Answering predefined questions, the panel drafted a statement based on the scientific evidence presented in open forum and the scientific literature. The draft statement was read in its entirety on the final day of the conference and circulated to the experts and the audience for comment. The panel then met in executive session to consider these comments and released a revised statement at the end of the conference. The statement was made available on the World Wide Web at http://consensus.nih.gov immediately after the conference. This statement is an independent report of the panel and is not a policy statement of the NIH or the Federal Government. CONCLUSIONS: The incidence of newly acquired hepatitis C infection has diminished in the United States. This decline is largely due to a decrease in cases among IDUs for reasons that are unclear and, to a lesser extent, to testing of blood donors for HCV. The virus is transmitted by blood and such transmission now occurs primarily through injection drug use, sex with an infected partner or multiple partners, and occupational exposure. The majority of infections become chronic, and therefore the prevalence of HCV infections is high, with about 3 million Americans now estimated to be chronically infected. HCV is a leading cause of cirrhosis, a common cause of HCC and the leading cause of liver transplantation in the United States. The disease spectrum associated with HCV infection varies greatly. Various studies have suggested that 3 to 20 percent of chronically infected patients will develop cirrhosis over a 20-year period, and these patients are at risk for HCC. Persons who are older at the time of infection, patients with continuous exposure to alcohol, and those co-infected with HIV or HBV demonstrate accelerated progression to more advanced liver disease. Conversely, individuals infected at a younger age have little or no disease progression over several decades. The diagnosis of chronic hepatitis C infection is often suggested by abnormalities in ALT levels and is established by EIA followed by confirmatory determination of HCV RNA. Several sensitive and specific assays are now partly automated for the purposes of detecting HCV RNA and quantifying the viral level. Although there is little correlation between viral level and disease manifestations, these assays have proven useful in identifying those patients who are more likely to benefit from treatment and, particularly, in demonstrating successful response to treatment as defined by an SVR. Liver biopsy is useful in defining baseline abnormalities of liver disease and in enabling patients and healthcare providers to reach a decision regarding antiviral therapy. Noninvasive tests do not currently provide the information that can be obtained through liver biopsy. Information on the genotype of the virus is important to guide treatment decisions. Genotype 1, most commonly found in the United States, is less amenable to treatment than genotypes 2 or 3. Therefore, clinical trials of antiviral therapies require genotyping information for appropriate stratification of subjects. Recent therapeutic trials in defined, selected populations have clearly shown that combinations of interferons and ribavirin are more effective than monotherapy. Moreover, trials using pegylated interferons have yielded improved SVR rates with similar toxicity profiles. However, results continue to show that the SVR rate is less common in patients with genotype 1 infections, higher HCV RNA levels, or more advanced stages of fibrosis. Genotype 1 infections require therapy for 48 weeks, whereas shorter treatment is feasible in genotype 2 and 3 infections. In genotype 1, the lack of an early virologic response (< 2 log decrease in HCV RNA) is associated with failure to achieve an SVR. The SVR is lower in patients with advanced liver disease than in patients without cirrhosis. Ongoing trials are exploring the usefulness of combination therapy in various populations. Preliminary experience in IDUs, individuals co-infected with HIV, children, and other special groups suggests similar responses are achievable in these populations. Patients with acute hepatitis C may be treated, but specific recommendations for antiviral treatment must await further evaluation of the rate of spontaneous clearance of the virus and determination of the optimal time to initiate treatment. Preventive measures beyond blood-banking practices include prompt identification of infected individuals, awareness of the potential for perinatal transmission, implementation of safe-injection practices, linkage of drug users to drug treatment programs, and implementation of community-based education and support programs to modify risk behavior. Some of these measures have been successfully implemented in the control of HIV infections, and it stands to reason that they would be valuable for reducing HCV transmission. Future advances in the diagnosis and management of hepatitis C require continued vigilance concerning the transmission of this infection, extending treatment to populations not previously evaluated in treatment trials, and the introduction of more effective therapies.

Acute Disease↗