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PubMed2002

Scientific priorities and strategic planning for resuscitation research and life saving therapy following traumatic injury: report of the PULSE Trauma Work Group.

Traumatic injury and its sequelae remain a major, unrecognized public health problem in North America. Traumatic injury is the principal cause of death in patients aged 1-44 years and the overall leading cause of life-years lost in the United States. Recognizing this, the National Heart, Lung, and Blood Institute (NHLBI), in conjunction with other federal agencies, organized a conference in June 2000 to discuss the basic and clinical research needs that could lead to improved outcomes following cardiopulmonary or post injury resuscitation. The Post Resuscitative and Initial Utility of Life Saving Efforts (PULSE) Workshop resulted and eight work groups were established to focus on various aspects, including organ systems, pharmacology, epidemiology, and trauma. The Trauma Work Group recommendations are presented in this article. Despite the recognition of improved survival and outcome through advancements in trauma systems and trauma care, the National Institutes of Health (NIH) support ratio for trauma research is only 0.10, compared with 1.65 for cancer research and a remarkable 3.51 for AIDS and HIV infection research. The successful federal HIV research program has significantly decreased the morbidity and mortality over the last ten years at a cost of $1.4 billion per year. A coordinated trauma research program should aim to replicate the success achieved by such programs; however, a centralized federal "home" for trauma research does not exist. Consequently, the existing limited research support is derived from NIH institutes in addition to other federal and state agencies. This report serves to describe some of the obstacles and outline various strategies and priorities for basic science, clinical, and translational trauma resuscitation research.

Emergency Medicine↗
PubMedDate not supplied

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↗
PubMedDate not supplied

Diagnosis and management of early melanoma: a consensus view.

The inefficacy of treatments for advanced melanoma have shifted the focus toward the recognition of early melanoma which is associated with a much more favorable outcome. In January 1992 the National Institutes of Health (NIH) held a Consensus Conference to establish definitions and therapeutic recommendations for the management of early melanoma. Early melanoma was defined as either in situ or invasive melanoma < 1 mm in depth. Surgical margins of 0.5 cm for in situ melanoma and 1 cm for invasive melanoma < or = 1 mm thick were recommended. The pathology reports should include as a minimum the diagnosis of melanoma, the maximum tumor thickness, and the status of the margins. Elective nodal dissection as well as high-tech radiologic procedures were not recommended. Follow-up of patients for the development of second primaries and of family members who may be at increased risk for melanoma was also recommended. Public education programs were suggested to inform the public of the increasing melanoma risk and improved survival through early detection.

Humans↗
PubMed2002

Choosing between endocrine therapy and chemotherapy--or is there a role for combination therapy?

Results from many randomized trials of adjuvant breast cancer therapy have been presented in several overviews and at subsequent meetings. This manuscript reviews the current status of both chemo- and endocrine therapy and the prospects for combination therapy, as summarized at the NIH and St Gallen Consensus meetings. In conclusion, treatment selection should be based primarily on endocrine responsiveness; however, a collaborative approach involving the development of new agents and investigation of their optimal integration into therapy programs will ensure progress and improved patient care.

Adult↗
PubMed2001

Protecting the most vulnerable: home mechanical ventilation as a case study in disability and medical care: report from an NIH conference.

Patients requiring chronic mechanical ventilation represent a particularly vulnerable segment of the expanding population of individuals with chronic disabilities. Many of these individuals can live successfully at home, but face significant obstacles. Current policies in health care coverage, durable medical equipment coverage, eligibility for assisted living, and licensing of caregivers all restrict the abilities of these individuals to live in the community. Prolonged home mechanical ventilation was pioneered in France, where a current international "best practice" provides a model for developing comprehensive, cost-effective care for these individuals.

Home Care Services↗
PubMed2005

Research opportunities for reducing the burden of menopause-related symptoms.

The National Institutes of Health (NIH) State-of-the-Science (SoS) Conference on the Management of Menopause-Related Symptoms identified a number of important gaps in our understanding of the natural history of the menopausal transition and the etiology and course of menopause-related symptoms. Updated information is needed from prospective studies of reproductive aging in diverse populations of women, especially of younger women in their mid reproductive years, to better understand the underlying biology of ovarian aging as well as the etiology of conditions leading to premature spontaneous or surgical menopause. To facilitate this goal, a number of methodologic issues must be addressed, including the development of (1) consensus definitions of menopause-related terms and stages, and (2) standard measures and methods for assessing progression through the menopausal transition and related symptoms and outcomes. Estrogen therapy is highly efficacious in relieving menopausal symptoms and was the treatment of choice until 2002, when findings of unexpected harm from the Women's Health Initiative (WHI) were published. Consequently, there has been a burgeoning interest in a number of botanical products as well as other complementary and alternative medicine strategies, such as acupuncture, magnets, homeopathy, and behavioral regimens. However the benefits of most of these strategies are either very limited or equivocal, and related safety issues are poorly understood. Future research is needed to identify new efficacious strategies, to understand side effects and safety issues, and to provide new options to women who are burdened by bothersome menopause-related symptoms.

Biomedical Research↗
PubMed2006

Metabolomics Standards Workshop and the development of international standards for reporting metabolomics experimental results.

Informatics standards and controlled vocabularies are essential for allowing information technology to help exchange, manage, interpret and compare large data collections. In a rapidly evolving field, the challenge is to work out how best to describe, but not prescribe, the use of these technologies and methods. A Metabolomics Standards Workshop was held by the US National Institutes of Health (NIH) to bring together multiple ongoing standards efforts in metabolomics with the NIH research community. The goals were to discuss metabolomics workflows (methods, technologies and data treatments) and the needs, challenges and potential approaches to developing a Metabolomics Standards Initiative that will help facilitate this rapidly growing field which has been a focus of the NIH roadmap effort. This report highlights specific aspects of what was presented and discussed at the 1st and 2nd August 2005 Metabolomics Standards Workshop.

Cell Physiological Phenomena↗
PubMed1997

Overview of clinical trials on endosseous implants.

Early history of clinical trials on endosseous implants revolved around anecdotal reports on predominantly blade implants in the U.S. The first criteria to define success or failure were established at the National Institutes of Health (NIH)-Harvard Conference in 1978. This was followed by the multi-center trials from the Branemark group which described round, metallic implants. At the 1988 NIH Conference, questions dealt with the following: 1) the effectiveness of dental implants for the long-term; 2) indications and contra-indications of various types of implants; 3) requirements for management of dental implants; 4) health risks of dental implants; and 5) future directions in research. In the ensuing 7 years since the second NIH Conference, most of the data generated have been from non-controlled case reports, which describe a 90% success rate in 5 years or more with many types of endosteal systems in both partially and fully edentulous patients. Therefore, it can be said that there is evidence that dental implants are effective for the long-term. The other questions posed at the 1988 NIH Conference have not been as well described and have led to many controversies and future research areas. Two areas which will have a special future impact are 1) the establishment of a standard of care and risk-benefit ratio for implants and 2) the use of various factors to accelerate bone formation to allow greater access to dental implants by patients.

Bone Regeneration↗
PubMed2003

Symptom management in cancer: pain, depression and fatigue: State-of-the-Science Conference Statement.

NIH Consensus Statements are prepared by a nonadvocate, non-Federal panel of experts, based on (1) presentations by investigators working in areas relevant to the consensus questions during a 2 day public session; (2) questions and statements from conference attendees during open discussion periods that are part of the public session; and (3) closed deliberations by the panel during the remainder of the second day and morning of the third. This statement is an independent report of the panel and is not a policy statement of the NIH or the Federal Government. The statement reflects the panel's assessment of medical knowledge available at the time the statement was written. Thus, it provides a "snapshot in time" of the state of knowledge on the conference topic. When reading the statement, keep in mind that new knowledge is inevitably accumulating through medical research.

Analgesics↗
PubMed1995

NIH consensus conference. Cochlear implants in adults and children.

OBJECTIVE: To provide clinicians and other health care providers with a current consensus on the benefits, limitations, and technical and safety issues that need to be considered in the use of cochlear implants. PARTICIPANTS: A nonfederal, nonadvocate, 14-member consensus panel representing the fields of otolaryngology, audiology, speech-language pathology, pediatrics, psychology, and education, and including a public representative. In addition, 24 experts in auditory anatomy and physiology, otolaryngology, audiology, aural rehabilitation, education, speech-language pathology, and bioengineering presented data to the consensus panel and a conference audience of 650. EVIDENCE: The literature was searched through MEDLINE and an extensive bibliography of references 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. CONSENSUS: The panel, answering predefined consensus questions, developed its conclusions based on the scientific evidence presented in open forum and the scientific literature. CONSENSUS STATEMENT: 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 the conference. CONCLUSIONS: Cochlear implantation improves communication ability in most adults with severe-to-profound deafness and frequently leads to positive psychological and social benefits as well. Currently, children at least 2 years old and adults with profound deafness are candidates for implantation. Cochlear implant candidacy should be extended to adults with severe hearing impairment and open-set sentence discrimination that is less than or equal to 30% in the best-aided condition. Access to optimal education and (re)habilitation services is important for adults and is critical for children to maximize the benefits available from cochlear implantation.

Adult↗
PubMed2006

The National Institutes of Health (NIH) State-of-the-Science Conference on Preventing Violence and Related Health-Risking Social Behaviors in Adolescents - a commentary.

Although youth in the United States remain substantially more violent than adolescents and young adults in most industrial countries, the National Institutes of Health's (NIH) State-of-the-Science Conference on Preventing Violence and Related Health-Risking Social Behaviors in Adolescents identified many reasons for optimism about our capacity to develop effective prevention and intervention responses. The research is getting better and contrary to popular opinion we do know a lot about what does work. Future advances will depend upon our insistence on the use of effectiveness evidence and the development of a taxonomy which will facilitate cross disciplinary communication.

Adolescent↗
PubMed2005

Introduction: papers from the National Institutes of Health State-of-the-Science Conference on Improving End-of-Life Care.

A 1997 Institute of Medicine report cited growing public concern about the quality of care in the U.S. health care system for persons at the end of life. The National Institute of Nursing Research (NINR), the lead Institute at the National Institutes of Health for end-of-life research, has conducted a number of public forums to gather information and to assist in identifying research priorities. The complexity of biomedical research requires new methods of discovery, and scientists must use a broad approach and explore new models of team science. In December 2004, NINR and the NIH Office of Medical Applications of Research, along with many co-sponsors, held an interdisciplinary State-of-the-Science Conference on Improving End-of-Life Care. The conference panel identified many gaps in our current state of knowledge and provided suggestions for future research directions. This supplement presents papers from a distinguished group of scientists with a wide range of backgrounds who participated in this state-of-the-science conference.

Humans↗
PubMed2006

National Institutes of Health State-of-the-Science Conference Statement : Preventing Violence and Related Health-Risking, Social Behaviors in Adolescents, October 13-15, 2004.

NIH consensus and state-of-the-science statements are prepared by independent panels of health professionals and public representatives on the basis of (1) the results of a systematic literature review prepared under contract with the Agency for Healthcare Research and Quality (AHRQ), (2) presentations by investigators working in areas relevant to the conference questions during a 2-day public session, (3) questions and statements from conference attendees during open discussion periods that are part of the public session, and (4) closed deliberations by the panel during the remainder of the second day and morning of the third. This statement is an independent report of the panel and is not a policy statement of the NIH or the Federal Government. The statement reflects the panel's assessment of medical knowledge available at the time the statement was written. Thus, it provides a "snapshot in time" of the state of knowledge on the conference topic. When reading the statement, keep in mind that new knowledge is inevitably accumulating through medical and behavioral research.

Adolescent↗
PubMedDate not supplied

NIH State-of-the-Science Statement on symptom management in cancer: pain, depression, and fatigue.

OBJECTIVE: To provide health care providers, patients, and the general public with a responsible assessment of currently available data regarding management of cancer symptoms such as pain, depression, and fatigue. PARTICIPANTS: A non-Federal, non-advocate, 13-member panel representing the fields of psychiatry, nursing, social work, medical oncology, pediatric oncology, epidemiology, pharmacology, radiation oncology, 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 cancer symptom management 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 audience for comment. The panel then met in executive session to consider the comments received 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: Too many cancer patients with pain, depression, and fatigue receive inadequate treatment for their symptoms. Clinicians should use brief assessment tools routinely to ask patients about pain, depression, and fatigue and to initiate evidence-based treatments. Current evidence to support the concept of cancer symptom clusters is insufficient, and additional theoretically driven research is warranted. Research is needed on the definition, occurrence, assessment, and treatment of pain, depression, and fatigue alone and together through adequately funded prospective studies. Fear of cancer and its consequences must be ameliorated. All patients with cancer should have optimal symptom control from diagnosis throughout the course of illness, irrespective of personal and cultural characteristics. The state of the science in cancer symptom management should be reassessed periodically.

Depression↗
PubMed1996

Gaucher disease. Current issues in diagnosis and treatment. NIH Technology Assessment Panel on Gaucher Disease.

OBJECTIVE: To provide physicians with a responsible assessment of the diagnosis and treatment of Gaucher disease. PARTICIPANTS: A nonfederal, nonadvocate, 14-member panel representing the fields of pediatrics, obstetrics and gynecology, genetics, endocrinology, molecular biology, internal medicine, and biostatistics. In addition, 30 experts in genetics, pediatrics, neurology, obstetrics and gynecology, orthopedics, hematology, genetic counseling, clinical pathology, and epidemiology presented data to the panel and a conference audience of 230 during a 1 1/2 public session. Questions and statements from conference attendees were considered during the open session. Closed deliberations by the panel occurred during the remainder of the second day and the morning of the third. EVIDENCE: The literature was searched through MEDLINE, and an extensive bibliography of references 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. CONSENSUS PROCESS: The panel, answering predefined questions, developed their conclusions based on the scientific evidence presented in open forum and on 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 the conference. CONCLUSIONS: Despite the success of enzyme therapy, treatment is limited by the cost of the agent. This makes it imperative to determine the lowest effective initial and maintenance doses, to define the appropriate clinical indications for treatment, and to establish uniform methods for optimize outcome assessment. The value of treatment for asymptomatic individuals has not been determined. General population screening for affected individuals and for carriers is not appropriate at this time. As a prototype for all rare diseases, the plight of patients with Gaucher disease raises difficult financial and ethical issues, which we as a society must address.

Clinical Enzyme Tests↗
PubMed2006

Immunohistochemical expression of p16INK4A, Ki-67, and Mcm2 proteins in gastrointestinal stromal tumors: prognostic implications and correlations with risk stratification of NIH consensus criteria.

BACKGROUND: Inactivation of p16(INK4A) promotes G1/S progression of cell cycle. Minichromosome maintenance protein-2 (Mcm2), a novel cell proliferation marker, is known to better correlate with clinical outcomes than Ki-67 in many carcinomas. Since gastrointestinal stromal tumors (GISTs) sometimes remains challenging in prognostication, we analyzed the utility of these three markers in GISTs. METHODS: Immunohistochemistry was performed in tissue microarrays of 277 primary GISTs and correlated with NIH consensus criteria and clinical outcomes. RESULTS: The increment of NIH risk levels significantly correlated with increasing labeling indices (LI) of both Ki-67 (P <.001) and Mcm2 (P <.001) and loss of p16(INK4A) expression (P <.035). However, the latter aberration did occur in 23% of very low/low-risk GISTs. The relationship between Mcm2 and Ki-67 LIs could be modeled as linear (P <.001, r = 0.697), while Mcm2 LI was considerably higher (P <.001) with a stepwise escalation related to risk levels. Ki-67 LI >5% (P <.0001) and Mcm2 LI >10% (P <.0001) were strongly predictive of inferior disease-specific survival (DSS), while aberrant loss of p16(INK4A) only reached a trend (P = .0954). In multivariate analyses, independent adverse factors of DSS were high-risk category (RR = 16.93, P <.0001), metastatic disease (RR = 4.12, P = .0015), Ki-67 LI >5% (RR = 3.55, P = .001), and presence of epithelioid histology (RR = 2.17, P = .0308). CONCLUSIONS: Prognostic efficacy of NIH consensus criteria is substantiated. P16(INK4A) deregulation can occur early in GIST tumorigenesis and marginally correlates with patient survival. Despite Ki-67 LI being an independent prognosticator, simultaneous detection of Mcm2 is recommended as a prognostic adjunct of GISTs, given its better sensitivity and stepwise escalation with increasing risk levels.

Adult↗