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PubMed2002

Noninvasive measurement of iron: report of an NIDDK workshop.

An international workshop on the noninvasive measurement of iron was conducted by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) on April 17, 2001, to assess the current state of the science and to identify areas needing further investigation. The workshop concluded that a clear clinical need is evident for quantitative, noninvasive, safe, accurate, and readily available means of measuring body storage iron to improve the diagnosis and management of patients with iron overload from such disorders as hereditary hemochromatosis, thalassemia major, sickle cell disease, aplastic anemia, and myelodysplasia, among others. Magnetic resonance imaging (MRI) potentially provides the best available technique for examining the 3-dimensional distribution of excess iron in the body, but further research is needed to develop means of making measurements quantitative. Biomagnetic susceptometry provides the only noninvasive method to measure tissue iron stores that has been calibrated, validated, and used in clinical studies, but the complexity, cost, and technical demands of the liquid-helium-cooled superconducting instruments required at present have restricted clinical access to the method. The workshop identified basic and clinical research opportunities for deepening our understanding of the physical properties of iron and iron toxicity, for further investigation of MRI as a method for quantitative determinations of tissue iron, especially in liver, heart and brain, and for development of improved methods and more widely available instrumentation for biomagnetic susceptometry.

Diagnostic Imaging↗
PubMed2005

The future of multiple sclerosis therapies: redesigning multiple sclerosis clinical trials in a new therapeutic era.

Due to past success in testing and gaining regulatory approval for a variety of therapies in multiple sclerosis (MS), the conduct of future clinical trials has become increasingly problematic. An international workshop has met to discuss the issues facing the MS clinical trial community and to examine possible new strategies for the design of trials. Particular focus has been placed on trials that either avoid the use of a placebo because of ethical considerations or on designs that allow new therapies to be studied more rapidly or with fewer patients than needed in a conventional placebo-controlled trial. The discussions resulting from the workshop should provide a basis for the examination and implementation of innovative clinical trial designs in MS.

Adjuvants, Immunologic↗
PubMed2003

A consensus statement on considerations for a successful CPOE implementation.

In May of 2001, thirteen experts on computerized provider order entry (CPOE) from around the world gathered at a 2-day conference to develop a consensus statement on successful CPOE implementation. A qualitative research approach was used to generate and validate a list of categories and considerations to guide CPOE implementation.

Decision Support Systems, Clinical↗
PubMed1990

Report of the National Cancer Institute-sponsored workshop on definitions of diagnosis and response in acute myeloid leukemia.

The National Cancer Institute (NCI) sponsored a workshop to develop a set of standardized diagnostic and response criteria for acute myeloid leukemia (AML) clinical trials. The French-American-British (FAB) classification was retained for diagnosing AML, with the addition of patients with bone marrow morphologic features of a myelodysplastic syndrome and less than 30% bone marrow blasts, but with greater than or equal to 30% blasts in the peripheral blood. In this report, there are four important subgroups of AML not defined in the FAB classification that are discussed: undifferentiated acute leukemia, MO (AML lacking definitive myeloid differentiation by morphology or conventional cytochemistry but with ultrastructural or immunophenotypic evidence for AML), mixed lineage leukemia, and hypocellular AML. Definitions of response for clinical trials are presented to facilitate comparisons among different studies. Complete remission is considered the only response worth reporting in phase III trials, since lesser responses do not improve survival. Partial remissions may be of interest to identify active new agents in phase I and II studies. Monoclonal antibodies and cytogenetic studies are not part of the routine assessment of remission or reassessment at relapse, and their role in the evaluation of patients with AML is currently being evaluated in clinical trials. Although we recognize that some of the definitions in this report are arbitrary, generalized use of these guidelines will make results of clinical trials more comparable and interpretable.

Antibodies, Monoclonal↗
PubMed1999

Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: recommendations from the Prostate-Specific Antigen Working Group.

PURPOSE: Prostate-specific antigen (PSA) is a glycoprotein that is found almost exclusively in normal and neoplastic prostate cells. For patients with metastatic disease, changes in PSA will often antedate changes in bone scan. Furthermore, many but not all investigators have observed an association between a decline in PSA levels of 50% or greater and survival. Since the majority of phase II clinical trials for patients with androgen-independent prostate cancer (AIPC) have used PSA as a marker, we believed it was important for investigators to agree on definitions and values for a minimum set of parameters for eligibility and PSA declines and to develop a common approach to outcome analysis and reporting. We held a consensus conference with 26 leading investigators in the field of AIPC to define these parameters. RESULT: We defined four patient groups: (1) progressive measurable disease, (2) progressive bone metastasis, (3) stable metastases and a rising PSA, and (4) rising PSA and no other evidence of metastatic disease. The purpose of determining the number of patients whose PSA level drops in a phase II trial of AIPC is to guide the selection of agents for further testing and phase III trials. We propose that investigators report at a minimum a PSA decline of at least 50% and this must be confirmed by a second PSA value 4 or more weeks later. Patients may not demonstrate clinical or radiographic evidence of disease progression during this time period. Some investigators may want to report additional measures of PSA changes (ie, 75% decline, 90% decline). Response duration and the time to PSA progression may also be important clinical end point. CONCLUSION: Through this consensus conference, we believe we have developed practical guidelines for using PSA as a measurement of outcome. Furthermore, the use of common standards is important as we determine which agents should progress to randomized trials which will use survival as an end point.

Androgens↗
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↗
PubMed1991

Practice guidelines and malpractice litigation: collision or cohesion?

Practice guidelines are standardized specifications for managing particular clinical problems and are intended to improve the outcomes of medical care by increasing adherence to standards of care. They are also meant to make medicine more cost-effective by eliminating unnecessary procedures. A relatively recent phenomenon, the practice guidelines now emerging will have implications for malpractice, which also intends to bring about better care. They will probably not revolutionize the procedures that courts use to determine negligence, but judges will integrate guidelines into their decision-making process. This development should be welcomed. Guidelines should prove to be useful as either inculpatory or exculpatory evidence of negligence. They are unlikely to generate much new litigation, although there is some potential for suits against those who issue guidelines, especially if guidelines are not revised as the technology of medical care changes.

Clinical Medicine↗
PubMed1994

Genetic and molecular ecotoxicology: a research framework.

Participants at the Napa Conference on Genetic and Molecular Ecotoxicology assessed the status of this field in light of heightened concerns about the genetic effects of exposure to hazardous substances and recent advancements in our capabilities to measure those effects. We present here a synthesis of the ideas discussed throughout the conference, including definitions of important concepts in the field and critical research needs and opportunities. While there were many opinions expressed on these topics, there was general agreement that there are substantive new opportunities to improve the impact of genetic and molecular ecotoxicology on prediction of sublethal effects of exposure to hazardous substances. Future studies should emphasize integration of genetic ecotoxicology, ecological genetics, and molecular biology and should be directed toward improving our understanding of the ecological implications of genotoxic responses. Ecological implications may be assessed at either the population or ecosystem level; however, a population-level focus may be most pragmatic. Recent technical advancements in measuring genetic and molecular responses to toxicant exposure will spur rapid progress. These new techniques have considerable promise for increasing our understanding of both mechanisms of toxicity on genes or gene products and the relevance of detrimental effects to individual fitness.

Animals↗
PubMed1995

Health Services Technology/Assessment Text (HSTAT).

Health Services Technology/Assessment Text (HSTAT), an online collection of documents pertaining to clinical practice guidelines, HIV/AIDS treatment information, and health care decision making, was recently introduced by the National Library of Medicine. Access to HSTAT is available through the NLM Full-Text Retrieval System (FTRS), a document search and retrieval system developed by the Information Technology Branch of NLM. Internet FTP, Gopher, and World Wide Web clients may also be used to obtain documents from the HSTAT collection.

Acquired Immunodeficiency Syndrome↗
PubMed1998

Bone and the hematopoietic and immune systems: a report of the proceedings of a scientific workshop.

Recent observations underscore the linkage between endochondral bone formation and the establishment of hematopoietic marrow and suggest that interactions among bone, marrow, and the immune system persist in the mature skeleton. A workshop was held at the National Institutes of Health, Bethesda, Maryland, to discuss recent work on these interactions and to identify new areas of research. Marrow stromal cells include the precursors of the osteochondrogenic lineage, exert important influences on osteoclastogenesis and lymphopoiesis, and mediate the effects of some systemic factors on bone turnover. Recent evidence indicates that hematopoietic cells can influence the differentiation of osteogenic cells and suggests that mature lymphocytes can influence osteoclastic and osteoblastic functions. However, interpretation of experiments may be confounded by the potential for stage-specific responses within a cell lineage, the likelihood that divergent pathways compete for limited pools of precursor cells, and the possibility that important cells or factors are still unidentified. Further, in vitro models may be limited by species and anatomical site specificities, the absence of intermediary or accessory cells, and the absence of normal marrow spatial organization and cellular interactions with the extracellular matrix. Nevertheless, current approaches hold the potential for significant advances in our understanding of the relationships between bone and the hematopoietic and immune systems. Refinements of in vitro systems, the use of genetically manipulated mice, and the examination of clinical syndromes promise important insights. Collaborations among bone biologists, hematologists, and immunologists, and between basic scientists and clinical investigators, will be crucial for continued progress.

Animals↗