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PubMed1995

Informed consent in emergency research. Consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers.

OBJECTIVE: A coalition conference of acute resuscitation researchers was held to discuss the feasibility of applying current federal research regulations regarding informed consent to the emergency setting. This article presents consensus recommendations for regulatory changes for consent in emergency research. PARTICIPANTS: Representatives from the Society for Academic Emergency Medicine and the American Heart Association identified several professional organizations as stakeholders in this issue, including research, clinical, bioethics, legal, and patient advocacy groups. The Office for Protection From Research Risks (OPRR), the Food And Drug Administration (FDA), and staff from specific legislative offices were also invited to observe. Forty-three participants attended, including representatives from 12 professional organizations, five medical institutions, and the FDA and OPRR. This was a closed meeting. Participants were self-funded or sponsored by their professional organizations. EVIDENCE: Before the meeting, a draft of a position statement was developed by the conference organizers based on the current literature and discussions with experts in the field. This draft, copies of the current federal research regulations, and supporting articles were distributed before the conference. CONSENSUS PROCESS: Participants rotated through moderated discussion sessions to comment on subsections of the draft. Following discussion, a working draft was developed and distributed to each participant and represented organizational board for final review. All comments were considered in the final version of the document. CONCLUSIONS: We believe there are circumstances when it is not feasible to obtain prospective or proxy consent for enrollment into an emergency research protocol. In these circumstances, patients are vulnerable, not only to research risks, but also to being denied potentially beneficial therapy when there is no known effective treatment for their life-threatening condition. We offer recommendations that should be met when the critical nature of the illness or injury or the need to apply an investigational therapy rapidly precludes prospective consent for participation in emergency research.

Consensus↗

PubMedDate not supplied

Prevention of a first stroke: a review of guidelines and a multidisciplinary consensus statement from the National Stroke Association.

OBJECTIVE: To establish, in a single resource, up-to-date recommendations for primary care physicians regarding prevention strategies for a first stroke. PARTICIPANTS: Members of the National Stroke Association's (NSA's) Stroke Prevention Advisory Board and Cedars-Sinai Health System Department of Health Services Research convened on April 9, 1998, in an open meeting. The conference attendees, selected to participate by the NSA, were recognized experts in neurology (9), cardiology (2), family practice (1), nursing (1), physician assistant practices (1), and health services research (2). EVIDENCE: A literature review was carried out by the Department of Health Services Research, Cedars-Sinai Health System, Los Angeles, Calif, using the MEDLINE database search for 1990 through April 1998 and updated in November 1998. English-language guidelines, statements, meta-analyses, and overviews on prevention of a first stroke were reviewed. CONSENSUS PROCESS: At the meeting, members of the advisory board identified 6 important stroke risk factors (hypertension, myocardial infarction [MI], atrial fibrillation, diabetes mellitus, blood lipids, asymptomatic carotid artery stenosis), and 4 lifestyle factors (cigarette smoking, alcohol use, physical activity, diet). CONCLUSIONS: Several interventions that modify well-documented and treatable cardiovascular and cerebrovascular risk factors can reduce the risk of a first stroke. Good evidence for direct stroke reduction exists for hypertension treatment; using warfarin for patients after MI who have atrial fibrillation, decreased left ventricular ejection fraction, or left ventricular thrombus; using 3-hydroxy-3 methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors for patients after MI; using warfarin for patients with atrial fibrillation and specific risk factors; and performing carotid endarterectomy for patients with stenosis of at least 60%. Observational studies support the role of modifying lifestyle-related risk factors (eg, smoking, alcohol use, physical activity, diet) in stroke prevention. Measures to help patients improve adherence are an important component of a stroke prevention plan.

Alcohol Drinking↗

PubMed2003

Reducing stigma and discrimination against older people with mental disorders: a technical consensus statement.

This technical consensus statement is jointly produced by the Old Age Psychiatry section of the World Psychiatric Association and the World Health Organization, with the collaboration of several NGOs and the participation of experts from different Regions. It is intended to be a tool for (i) promoting debate at all levels on the stigmatisation of older people with mental disorders; (ii) outlining the nature, causes and consequences of this stigmatisation; and (iii) promoting and suggesting policies, programmes and actions to combat this stigmatisation.

Aged↗

PubMed1994

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↗

PubMed2007

[Auditory processing disorders : Consensus statement by the German Society for Phoniatry and Paedaudiology].

The consensus statement published by the German Society for Phoniatry and Paedaudiology in the year 2000 has been revised and actualized. The revised version takes into account current scientific and clinical findings. Aspects of the definition of auditory processing disorders (APD) are described extensively. These include symptoms, anamnestic information and diagnostic steps (preliminary examinations, subjective and objective audiological procedures). APD can appear in different forms, some of which can be classified within subtypes. Furthermore, factors which need to be considered in order to differentiate between APD and other diseases are specified. Therapeutic intervention possibilities which are rated according to their prognostic values conclude the article.

Audiology↗

PubMed1995

Recommended guidelines for uniform reporting of pediatric advanced life support: the Pediatric Utstein Style. A statement for healthcare professionals from a task force of the American Academy of Pediatrics, the American Heart Association, and the European Resuscitation Council.

This consensus document is an attempt to provide an organized method of reporting pediatric ALS data in out-of-hospital, emergency department, and in-hospital settings. For this methodology to gain wide acceptance, the task force encourages development of a common data set for both adult and pediatric ALS interventions. In addition, every effort should be made to ensure that consistent definitions are used in all age groups. As health care changes, we will all be challenged to document the effectiveness of what we currently do and show how new interventions or methods of treatment improve outcome and/or reduce cost. Only through collaborative research will we obtain the necessary data. For these reasons, and to improve the quality of care and patient outcomes, it is the hope of the task force that clinical researchers will follow the recommendations in this document. It is recognized that further refinements of this statement will be needed; these recommendations will improve only when researchers, clinicians, and EMS personnel use them, work with them, and modify them. Suggestions, recommendations, and other comments aimed at improving the reporting of pediatric resuscitation should be sent to Arno Zaritsky, MD, Eastern Virginia Medical School, Children's Hospital of The King's Daughter, Division of Critical Care Medicine, 601 Children's Lane, Norfolk, VA 23507.

Child↗

PubMed2004

Consensus statement on office-based treatment of opioid dependence using buprenorphine.

Buprenorphine and buprenorphine/naloxone (BUP) are newly approved for office-based treatment of opioid dependence. Federal and non-federal regulatory and monitoring agencies, national and international researchers, national professional organizations, researchers involved in monitoring, opioid treatment programs and the pharmaceutical industry met to synthesize and disseminate practical information to guide training, practice, monitoring, regulation and evaluation efforts with these medications. We performed a review of the literature, training curricula and practice guidelines and commissioned manuscripts describing recently completed, or still in progress, studies or field experiences with BUP treatment. A consensus process generated fifteen statements: (1) The federal government should collect baseline data on opioid-related deaths and morbidity to assess the effect of BUP on public health, (2) the patient limit for group practices should apply to individual physicians rather than group practices, (3 and 4) telephone and Internet-based physician and pharmacist support is needed, (5) clinicians who provide psychosocial services to opioid dependent patients should be informed of the role of BUP, (6) opioid-dependent patients should be instructed to present for induction in mild withdrawal, (7) the existing Center for Substance Abuse Treatment guidelines provide a reasonable induction protocol, (8) physicians should be prepared to use ancillary medications with BUP induction, (9) a physician or nurse must be available to the patient during the induction period, (10) concurrent counseling and support services are necessary, (11) detoxification without appropriate followup addiction treatment leads to rapid relapse and is not as effective as maintenance, (12) pregnant opioid-dependent women should be treated using good clinical practice including specialist addiction care and prenatal care, (13) BUP induction and withdrawal treatment may benefit from different designations for payment, (14) take-home medication options should be tailored to patients' needs, (15) there is a need for clinical and policy research in unique patient populations.

Ambulatory Care↗

PubMed2006

Vascular endothelium summary statement I: Health promotion and chronic disease prevention.

The endothelium can be considered a discrete organ with pathophysiologic implications and as such has both diagnostic and therapeutic possibilities. It is essential for the normal function of the cardiovascular, cerebrovascular, renovascular, and pulmonary vascular system. The endothelium is directly involved in the development and progression of heart disease, stroke, peripheral vascular disease, venous thrombosis, insulin resistance, diabetes, chronic kidney failure, tumor growth, metastases and adverse reproductive outcomes for both the mother and her newborn child. Consequently the endothelium represents an objective biological determinant on which to base new multidisciplinary prevention and health promotion strategies. This summary statement suggests some possible avenues for clinical and public health research.

Animals↗

PubMed2006

Vascular endothelium summary statement VI: Research directions for the 21st century.

Effective translation of research advances from the bench to clinical and public health practice at the bedside and in the community at large represents an important step in the health research discovery enterprise. Increasingly, the gap in translating these advances into practice is being recognized. Successfully addressing this translational gap for the prevention and control of chronic diseases will require the development of novel, innovative, and, if necessary, nontraditional approaches. Participants in the 8th International Conference on Vascular Endothelium discussed a variety of novel approaches that have significant promise. Three of these approaches-vaccine development, genomics and proteomics, and tissue engineering-are highlighted in this position statement and strategies for public health practice and research are suggested.

Animals↗

PubMed2006

Vascular endothelium summary statement V: Pulmonary hypertension and acute lung injury: public health implications.

Although relatively rare, pulmonary hypertension can be devastating for those individuals who are affected and has significant societal implications. The 2003 WHO classification separates PAH (idiopathic, specific disease linked) from pulmonary hypertension related to lung disease, thromboembolic disease, and pulmonary venous hypertension. Another form of pulmonary hypertension, persistent pulmonary hypertension (PPHN), occurs in the newborn. In general, PPHN is thought to be responsible for approximately 10% of admissions to neonatal intensive care units and can be a complicating factor in 5 of 1000 live births. Acute lung injury (ALI) and the acute respiratory distress syndrome (ARDS) are complex disorders that pose a significant threat to critically ill patients. They are usually related to direct lung injury or indirect injury from sepsis, trauma, and other disorders. Although these pulmonary disorders reflect distinct pathophysiologic mechanisms, current evidence strongly suggests that a common denominator underlying many of the established molecular and cellular elements is endothelial cell activation and dysfunction. This summary statement briefly summarizes the state of the science and suggests future avenues of public health research.

Animals↗

PubMed2006

Vascular endothelium summary statement II: Cardiovascular disease prevention and control.

The prevention and control of cardiovascular disease (CVD), principally ischemic heart disease and stroke, are a major clinical and public health challenge. Worldwide, CVD accounts for substantial morbidity and mortality. The major modifiable CVD risk factors are known and all of them cause endothelial activation and dysfunction. Preventing and controlling the established risk factors are associated with preserved endothelial function and reduced risk of CVD. Research advances that improve our understanding of strategies to preserve endothelial function or make the endothelial cells resilient to environmental insults may help improve our preventive interventions. This summary statement addresses the current state of the science with respect to endothelial dysfunction and CVD pathogenesis, diagnostic evaluation, and suggested strategies for public health practice and research.

Animals↗

PubMed2002

Overview summary statement. Diagnosis and management of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).

Members of the Chronic Prostatitis Collaborative Research Network (CPCRN) met in a 1-day symposium to review recent findings and to debate unanswered issues in the diagnosis and management of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). The meeting was focused on producing an overview summary statement that would, as nearly as possible, represent the consensus views of the attendees. As discussed below, the participants agreed that a history, physical examination, and urinalysis/urine culture are mandatory for the evaluation of all patients presenting with CP/CPPS, with other assessments categorized as recommended or optional, depending on the history and physical findings. Observations and suggestions regarding first- and second-line therapies are also offered, with the recognition that randomized, placebo-controlled trials to guide selection of therapies for chronic nonbacterial prostatitis are currently lacking.

Biomarkers↗

PubMed2001

Consensus statement on the modern therapy of Paget's disease of bone from a Western Osteoporosis Alliance symposium. Biannual Foothills Meeting on Osteoporosis, Calgary, Alberta, Canada, September 9-10, 2000.

BACKGROUND: Bisphosphonate therapy remains the most effective way of controlling Paget's disease of bone (PD). Along with salmon calcitonin, etidronate has been the mainstay of therapy for approximately 20 years. However, the advent of newer bisphosphonates with different molecular actions on osteoclasts warrants a reevaluation of optimal treatment. OBJECTIVE: At a symposium of the Western Osteoporosis Alliance, physicians with experience in the management of PD met to review currently available information and generate this consensus statement as a guideline for clinicians and a source of information for health care payers. METHODS: All available randomized, double-blind, controlled studies that compared the efficacy of newer bisphosphonates with that of etidronate in the treatment of PD were identified through a search of MEDLINE using the terms Paget's disease, bisphosphonates, pamidronate, etidronate, alendronate, risedronate, tiludronate, clodronate, calcitonin, and salmon calcitonin. Because no such studies have been conducted for pamidronate, clodronate, or calcitonin, these drugs were not included in the analysis. CONCLUSIONS: The consensus of the symposium was that etidronate has little place in the modern management of PD. Newer bisphosphonates such as alendronate and risedronate provide significant therapeutic advantages over etidronate, both in the extent of reduction in bone-specific alkaline phosphatase (BSAP) and/or total serum alkaline phosphatase (SAP) and in the duration of remission, as measured by normalization of BSAP/SAP. In the absence of a direct comparison between alendronate and risedronate in the treatment of PD, physician choice is likely to be based on personal experience, relative cost, and differences in dosing.

Alendronate↗

PubMed2000

Consensus statement on the ethic of medicine.

Because Of Increasing Concern With The Ethical Challenges To Physicians In Recent Years, A Committee Of The Council Of Medical Specialty Societies (CMSS), Under The Chairmanship Of Sara C. Charles, Md, Organized A 2-DAY Symposium On The Ethic Of Medicine In April 1997. During This Conference 6 Workgroup Sessions Were Held For The Purpose Of Developing A Consensus Among The 17 Represented Medical And Surgical Specialties On Whether The Traditional Medical Ethic Remains Applicable Or Is In Need Of Adaptation Or Change To Guide Physician Behavior In The 21ST Century. An Initial Statement Was Developed At The Time Of The Meeting, Then Modified By Mail And Finally Presented To All 17 Member Societies For Further Comment. The Following Is The Result Of That Extended And In-DEPTH Review.

Ethics, Medical↗

PubMedDate not supplied

Resuscitation of the newly born infant: an advisory statement from the Pediatric Working Group of the International Liaison Committee on Resuscitation.

The International Liaison Committee on Resuscitation (ILCOR), with representation from North America, Europe, Australia, New Zealand, Africa, and South America, was formed in 1992 to provide a forum for liaison between resuscitation organizations in the developed world. This consensus document on resuscitation extends previously published ILCOR advisory statements on resuscitation to address the unique and changing physiology of the newly born infant within the first few hours following birth and the techniques for providing advanced life support. After careful review of the international resuscitation literature and after discussion of key and controversial issues, consensus was reached on almost all aspects of neonatal resuscitation, and areas of controversy and high priority for additional research were delineated. Consensus on resuscitation for the newly. born infant included the following principles. (i) Personnel trained in the basic skills of resuscitation should be in attendance at every delivery. A minority (fewer than 10%) of newly born infants require active resuscitative interventions to establish a vigorous cry and regular respirations, maintain a heart rate greater than 100 beats per minute (bpm), and maintain good color and tone. (ii) When meconium is present in the amniotic fluid, it should be suctioned from the hypopharynx on delivery of the head. If the meconium-stained newly born infant has absent or depressed respirations, heart rate, or muscle tone, residual meconium should be suctioned from the trachea. (ii) Attention to ventilation should be of primary concern. Assisted ventilation with attention to oxygen delivery, inspiratory time, and effectiveness judged by chest rise should be provided if stimulation does not achieve prompt onset of spontaneous respirations and/or the heart rate is less than 100 bpm. (iv) Chest compressions should be provided if the heart rate is absent or remains less than 60 bpm despite adequate assisted ventilation for 30 s. Chest compressions should be coordinated with ventilations at a ratio of 3:1 and a rate of 120 'events' per minute to achieve approximately 90 compressions and 30 rescue breaths per minute. (v) Epinephrine should be administered intravenously or intratracheally if the heart rate remains less than 60 bpm despite 30 s of effective assisted ventilation and chest compression circulation. Common or controversial medications (epinephrine, volume expansion, naloxone, bicarbonate), special resuscitation circumstances affecting care of the newly born, continuing care of the newly born after resuscitation, and ethical considerations for initiation and discontinuation of resuscitation are discussed. There was agreement that insufficient data exist to recommend changes to current guidelines regarding the use of 21% versus 100% oxygen, neuroprotective interventions such as cerebral hypothermia, use of a laryngeal mask versus endotracheal tube, and use of high-dose epinephrine. Areas of controversy are identified, as is the need for additional research to improve the scientific justification of each component of current and future resuscitation guidelines.

Humans↗

PubMed1999

Communication teaching and assessment in medical education: an international consensus statement. Netherlands Institute of Primary Health Care.

The importance of communication between doctors and patients has been well established, and there is growing acceptance of the need to teach and assess communication skills in medical schools. Faculty meeting at a consensus workshop during the International Conference on Teaching Communication in Medicine (Oxford, July 1996) generated a series of recommendations for developing and implementing teaching and assessment programmes. The points were refined in subsequent discussions with other interested groups, and endorsed in their current form by a workshop of teachers attending the Communication in Health Care Conference organized by NIVEL, the Netherlands Institute of Primary Health Care (Amsterdam, June 1998). While focused on medical schools, the eight recommendations highlighted in this consensus statement are also relevant to both graduate and continuing medical education programmes: (1) teaching and assessment should be based on a broad view of communication in medicine; (2) communication skills teaching and clinical teaching should be consistent and complementary; (3) teaching should define, and help students achieve, patient-centred communication tasks; (4) communication teaching and assessment should foster personal and professional growth; (5) there should be a planned and coherent framework for communication skills teaching; (6) students' ability to achieve communication tasks should be assessed directly; (7) communication skills teaching and assessment programmes should be evaluated; (8) faculty development should be supported and adequately resourced.

Clinical Competence↗

PubMed2003

Prevention and treatment of malignant syndrome in Parkinson's disease: a consensus statement of the malignant syndrome research group.

We report a consensus statement of the collaborative research group on the prevention and treatment of malignant syndrome (MS) in Parkinson's disease. The syndrome is quite similar to neuroleptic MS. Although sudden withdrawal of levodopa was the most frequent cause, many other precipitating events were found such as intercurrent infections, dehydration, hot weather, discontinuation of other anti-parkinsonian drugs, and "wearing off" phenomenon. Awareness of this syndrome is most important for its early detection and the prompt commencement of treatment. MS should be suspected whenever the body temperature rises above 38 degrees C without an apparent cause. Treatment consists of ample intravenous fluid, cooling the body, anti-parkinsonian drugs (particularly levodopa and bromocriptine), dantrolene sodium, and antibiotics if infection is present. Rhabdomyolysis, disseminated intravascular coagulation, and acute renal failure constitute serious complications.

Antiparkinson Agents↗

PubMed2004

Evaluation of the response to treatment of solid tumours - a consensus statement of the International Cancer Imaging Society.

New guidelines to evaluate the response to treatment in solid tumors using imaging techniques have major limitations and important implications for radiological workload. This consensus statement from the International Cancer Imaging Society (ICIS) reviews the RECIST criteria and addresses several challenges regarding tumour measurement. Recommendations are made regarding tumour measurement and other issues are raised. The growing need to introduce a multimodality approach to monitoring response is recognized. ICIS welcomes a dialogue with the authors of RECIST to address issues raised in this review.

Clinical Trials as Topic↗