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PubMed2004

The ethics of end-of-life research.

A notable and welcome increase in palliative care research has led to a multitude of ethical issues and concerns for researchers, clinicians, patients (subjects) and their family members (who also might be subjects), granting agencies, and professional journals. This edition of "Palliative Care Pearls" summarizes the recommendations from a work group that met at the National Institutes of Health in September, 2002. The primary purpose for that meeting was to explore the unique characteristics of this research population and the ethical concerns that might require tailoring of "standard" clinical research processes. The proceedings culminated in a document from which open discourse and a more formal set of guidelines might emanate to both foster more and better research, while providing protections for research subjects. This 62 page long monograph was published as a supplement to the Journal of Pain and Symptom Management (April, 2003). It includes six "plenary" papers, each that focuses on a distinct ethical domain of palliative care research and concludes with a set of recommendations and research questions. These might best be viewed as hypotheses that need to be tested or further explored.

Clinical Trials as Topic↗
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↗
PubMed2006

The newborn drug development initiative workshop: Summary proceedings from the neurology group on neonatal seizures.

BACKGROUND: The neonatal period eclipses all other epochs of the human life span for the highest incidence of seizures. Neonatal seizures are most commonly incited by serious acute illnesses such as hypoxic-ischemic encephalopathy, birth trauma, or infection. OBJECTIVE: The goal of this article was to summarize some of the Neurology Group's discussion on neonatal seizures and their treatment with phenobarbital (PB). METHODS: Information for this article was gathered from a workshop held March 29 and 30, 2004, in Baltimore, Maryland, as part of the Newborn Drug Development Initiative. A group of national experts was invited to form the Neurology Group to review certain aspects of neonatal seizures. Literature reviews were conducted using MEDLINE searches for original research studies, commentaries, and review articles between 1980 and 2004 using the key words neonatal seizures, treatment, and phenobarbital. RESULTS: It has been empirically established that infants who experience seizures face substantially higher mortality and morbidity rates than those who do not. Basic research indicates that neonatal seizures themselves are not innocuous and actively contribute to adverse neurodevelopmental outcomes. Current worldwide clinical practice most often includes empiric treatment with PB for definite or suspected seizures in the newborn. Unfortunately, this common practice has never been proven by even a single, rigorous, randomized controlled trial. The Neurology Group identified the treatment of neonatal seizures with PB as an important topic in the practice of neonatal neurology for further investigation. Three possible frameworks for ethically acceptable, clinical treatment trials were explored. From these, a suitable scenario was selected-an electroencephalographer-blinded study of PB versus placebo in a homogeneous group of newborns who are at high risk of developing early subclinical electroencephalographic neonatal seizures (ENSs). Prospective video-electroencephalogram monitoring performed immediately after an insult (such as major cardiac surgery for a serious congenital heart defect) would establish the presence and number of subclinical ENSs. For a brief period of time, neonates with subclinical ENSs would be randomized to PB (dosed to match the PB-binding characteristics of the individual) or placebo. Clear criteria for escape from the study to active treatment are defined. CONCLUSION: The investigation proposed here could refute or confirm the contemporary practice of PB administration as the first-line treatment of neonatal seizures.

Anticonvulsants↗
PubMed1991

Impacts of geriatric evaluation and management programs on defined outcomes: overview of the evidence.

Comprehensive geriatric assessment is a technique for multidimensional diagnosis of frail elderly people with the purpose of planning and/or delivering medical, psychosocial, and rehabilitative care. When comprehensive geriatric assessment is coupled with some therapy, then the term geriatric evaluation and management (GEM) will be used. Following a brief history of comprehensive geriatric assessment, we describe the varied patterns of GEM program organization and review the literature of studies examining GEM effectiveness. Program diversity complicates drawing firm conclusions about GEM effects; however, the vast majority of studies report positive, if not uniformly significant, results. Our analysis suggests that much of the variability in findings is due to sample size limitations. In order to reach conclusions of program effects across studies and to avoid problems of small sample sizes, we undertook a formal meta-analysis. In this initial meta-analysis, we sought to evaluate the effect of GEM programs on a single outcome: mortality. We pooled all published GEM controlled trials into four major groups: inpatient consultation services, inpatient GEM units, home assessment services, and outpatient GEM programs. Meta-analysis of 6-month mortality demonstrates a 39% reduction of mortality for inpatient consultation services (odds ratio 0.61, 95% confidence interval 0.46-0.81, P = 0.0008) and a 37% reduction of mortality for inpatient GEM units (odds ratio 0.63, 95% CI 0.42-0.93, P = 0.02). Home assessment services reduced mortality by 29% (odds ratio 0.71, 95% CI 0.55-0.90, P = 0.005). On the other hand, no significant survival effect was found for outpatient GEM programs (odds ratio 0.96, 95% confidence interval 0.61-1.49).(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMed1999

Insomnia: assessment and management in primary care. National Heart, Lung, and Blood Institute Working Group on Insomnia.

Patients with insomnia may experience one or more of the following problems: difficulty falling asleep, difficulty maintaining sleep, waking up too early in the morning and nonrefreshing sleep. In addition, daytime consequences such as fatigue, lack of energy, difficulty concentrating and irritability are often present. Approximately 10 percent of adults experience persistent insomnia, although most patients do not mention it during routine office visits. Asking sleep-related questions during the general review of systems and asking patients with sleep complaints to keep a sleep diary are helpful approaches in detecting insomnia. Behavior and pharmacologic therapies are used in treating insomnia. Behavior approaches take a few weeks to improve sleep but continue to provide relief even after training sessions have ended. Hypnotic medications are safe and effective in inducing, maintaining and consolidating sleep. Effective treatment of insomnia may improve the quality of life for many patients.

Adult↗
PubMedDate not supplied

NIH state-of-the-science statement on management of the clinically inapparent adrenal mass ("incidentaloma").

OBJECTIVE: To provide health care providers, patients, and the general public with a responsible assessment of currently available data regarding the management of clinically inapparent adrenal masses ("incidentalomas"). PARTICIPANTS: A non-Federal, nonadvocate, 12-member panel representing the fields of medicine, surgery, endocrinology, pathology, biostatistics, epidemiology, radiology, 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 incidentaloma 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 management of clinically inapparent adrenal masses is complicated by limited studies of incidence, prevalence, and natural history, including the psychologic impact on the patient who is informed of the diagnosis. Improvements in the resolution of abdominal imaging techniques combined with increased use of abdominal imaging suggest that the prevalence of clinically inapparent adrenal masses will continue to escalate. The low prevalence of adrenal cortical carcinomas and the relatively low incidence of progression to hyperfunction call into question the advisability of the current practice of intense, long-term clinical followup of this common condition. All patients with an incidentaloma should have a 1-mg dexamethasone suppression test and a measurement of plasma-free metanephrines. Patients with hypertension should also undergo measurement of serum potassium and plasma aldosterone concentration/plasma renin activity ratio. A homogeneous mass with a low attenuation value (less than 10 HU) on CT scan is likely a benign adenoma. Surgery should be considered in all patients with functional adrenal cortical tumors that are clinically apparent. All patients with biochemical evidence of pheochromocytoma should undergo surgery. Data are insufficient to indicate the superiority of a surgical or nonsurgical approach to manage patients with subclinical hyperfunctioning adrenal cortical adenomas. Recommendations for surgery based upon tumor size are derived from studies not standardized for inclusion criteria, length of followup, or methods of estimating the risk of carcinoma. Nevertheless, patients with tumors greater than 6 cm usually are treated surgically, while those with tumors less than 4 cm are generally monitored. In patients with tumors between 4 and 6 cm, criteria in addition to size should be considered in making the decision to monitor or proceed to adrenalectomy. The literature on adrenal incidentaloma has proliferated in the last several years. Unfortunately, the lack of controlled studies makes formulating diagnostic and treatment strategies difficult. Because of the complexity of the problem, the management of patients with adrenal incidentalomas will be optimized by a multidisciplinary team approach involving physicians with expertise in endocrinology, radiology, surgery, and pathology. The paucity of evidence-based data highlights the need for well-designed prospective studies. Either open or laparoscopic adrenalectomy is an acceptable procedure for resection of an adrenal mass. The choice of procedure will depend upon the likelihood of an invasive adrenal cortical carcinoma, technical issues, and the experience of the surgical team. In patients with tumors that remain stable on two imaging studies carried out at least 6 months apart and do not exhibit hormonal hypersecretion over 4 years, further followup may not be warranted.

Adrenal Gland Neoplasms↗
PubMed2005

National Institutes of Health Consensus Development Conference Statement on Celiac Disease, June 28-30, 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 research.

Biomedical Research↗
PubMed1979

NIH panels analyze issues on technology.

Experts at NIH's "consensus development" technology assessment conferences study a wide range of issues and make recommendations to help guide users of medical technologies.

Congresses as Topic↗
PubMed1994

Evaluation of reduced protocols for carcinogenicity testing of chemicals: report of a joint EPA/NIEHS workshop.

The current U.S. Environmental Protection Agency (EPA) and other national/international guidelines specify the use of two species and two sexes rodents (usually the rat and the mouse) for carcinogenicity testing of chemicals. In view of the enormous number of chemicals to be tested, the high cost of testing, and the large number of animals used in the present protocol, many academic, industrial, and government authorities are examining the possibility of using a reduced protocol (less than two species and two sexes of rodents) for carcinogenicity testing of chemicals. The use of a reduced protocol offers many advantages as well as some disadvantages. To pursue further the potential implications and impacts of using a reduced protocol for carcinogenicity testing on the processes of hazard identification and risk assessment, a workshop entitled "Evaluation of Reduced Protocols for Carcinogenicity Testing of Chemicals" was held at the Embassy Suites Hotel in Alexandria, Virginia on September 22 and 23, 1992. It was cosponsored by EPA's Office of Prevention, Pesticides and Toxic Substances (OPPTS) and the National Toxicology Program of the National Institutes of Environmental Health Sciences (NTP/NIEHS) and attended by more than 60 participants from government, industry, academia, and the general public. The Expert Consensus Panel and most of the participants supported the use of reduced protocols in carcinogenicity testing. However, it was recognized that reduced protocols may not be appropriate for the testing of all chemicals and that additional analyses/data may be needed for selection of the most appropriate reduced protocol for certain chemicals/chemical classes.

Animals↗
PubMed2005

Challenges and opportunities in clinical trials for spinal muscular atrophy.

Spinal muscular atrophy (SMA) is the most common fatal neuromuscular disease of infancy. SMA type I is the most severe and mortality is usually due to respiratory failure. In type II the disability is of later onset and less severe, and prognosis has improved primarily due to supportive care. Type III is the mildest form with onset usually of weakness in adolescence or young adulthood. SMA is an autosomal recessive disorder with deletions or mutations of the gene at the 5 q11 locus. There is no specific prevention or treatment, but current progress toward potential therapies has been substantial and several candidates including histone deacetylase (HDAC) inhibitors are under consideration for further evaluation. The authors sought to address the challenges and opportunities for testing new therapies for SMA.

Child↗
PubMed2006

National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: VI. Design of Clinical Trials Working Group report.

The complexity of chronic graft-versus-host disease (GVHD) and the lack of established research methods have made it difficult to design, conduct, and analyze clinical trials involving subjects with this disease, even when promising treatment options are available. This consensus document was developed to offer an approach for overcoming these obstacles. Clinical trials in chronic GVHD should adhere to principles of good trial design and practice. Inclusion and exclusion criteria should allow as many subjects to participate as possible without compromising the interpretation of results. Pre-enrollment assessment of chronic GVHD characteristics should be standardized. The protocol should provide clear guidance about administration of study medication and other interventions. Methods of assessing response should be defined and validated in advance. Efficacy endpoints should be selected to reflect clinical benefit. Expert biostatistical support is needed to ensure the validity and reliability of trial results. The use of consistent standards in clinical trial designs to evaluate agents that have activity in pathogenic pathways could facilitate advances in the treatment of chronic GVHD.

Adrenal Cortex Hormones↗