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We have assessed the discriminant validity of functional status measures and measures that are part of the core set for rheumatoid arthritis. Papers were identified by a systematic literature search in MEDLINE and hand searching of references.
To assess existing information regarding detectable differences in osteoarthritis (OA), a systematic literature search was conducted up to December 1999. Thirty-three articles were considered methodologically relevant to the definition and categorization of detectable differences in OA. It was determined that the musculoskeletal literature contains a wealth of information that relates to observed changes, much of which is derived from the clinical trials literature, but there have been relatively few methodological studies that have systematically evaluated the nature, categorization, and relevance of the change. Furthermore, most of those that have been published take the perspective of an individual or groups of experts other than that of the patient. This summary of the current literature reveals that the diverse sources of information go part way towards developing an understanding of detectable differences and their importance in the area of OA research and clinical practice. Stakeholders' interests as well as factors that modulate perceptions of importance need to be taken under consideration. In particular, the patient's perspective of the importance of change at an individual level requires further evaluation. This area of clinical research is relatively underdeveloped, but there is considerable opportunity for progress.
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Since cancer chemotherapy is generally carried out in the combination form, seldom in single regimen, a new treatment using new drug is not readily available for the clinical use, unless appropriate clinical trial will be performed. Although most clinical trials so far have been used to in the company-oriented-form in our country, new aspects and challenge to the cancer chemotherapy strongly demand to establish stable system to conduct a qualified clinical trial independently conducted from the company. The problems related to this item were analyzed based on the author's own experience of JFMC, and urgent motion was proposed thereupon.
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The authors are privileged to have been provided with correspondence about a dispute over the ongoing storage of genetic material (as Guthrie Cards) in Victoria. The correspondence details confusion over the roles of government and the private sector service provider in accounting for the storage, use and destruction of these stored genetic materials collected as part of a government public health program. The purpose in publishing this account is to highlight the present inadequacies in current practices and the ongoing potential for a crisis in the management of collected genetic materials through a lack of appropriate regulation, transparency and accountability. The article suggests measures to remedy some of the existing inadequacies in contractual arrangements and recommends that the government retain ownership and control of both the genetic materials and the derived information to ensure some accountability in the present legal environment.
The paper illustrates the system WITH (Write on Internet clinical Trials in Haematology) which supports the writing of a clinical trial (CT) document. The requirements of this system have been defined analysing the writing process of a CT and then modelling the content of its sections together with their logical and temporal relationships. The system WITH allows: a) editing the document text; b) re-using the text; and c) facilitating the cooperation and the collaborative writing. It is based on XML mark-up language, and on a RDBMS. This choice guarantees: a) process standardisation; b) process management; c) efficient delivery of information-based tasks; and d) explicit focus on process design.
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There is currently no harmonized way in Japan to manage safety data which are obtained during clinical trials supported by Government funds. There are two types of clinical trials, 'sponsored trials(sponsored by industrial companies)' and 'non-sponsored trials(funded by the Government, etc.)'. The Japanese Ministry of Health and Welfare has issued many of pharmaceutical laws(GCP, GPMSP etc.) for the regulation of sponsored trials, while none has ever established for non-sponsored trials, thus leaving the most important quality control/assurance unregulated. In this manuscript we discuss that the simple application of pharmaceutical laws to government-sponsored trials can not be a proper answer because of the different nature of the two types of trials.
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The National Health and Nutrition Examination Survey (NHANES), developed by the Centers for Disease Control and Prevention (CDC), is a large and comprehensive health survey utilizing leading edge technologies to produce national estimates of health measures and the nutritional status of the U.S. population. Early NHANES metadata models grouped data by categories with little specificity and often not capturing the complexity of the survey. Subsequently, existing models at the Census Bureau, CDC, and the EPA were evaluated in addition to industry standards, such as DDI, Dublin Core, and ISO 1179. For the NHANES metadata model, the DDI standard and CDC Public Health Conceptual Model were chosen as the backbone for constructing the data model. The new model has led to increased data accuracy and several value-added products for producing codebooks, automatically checking questionnaire skip patterns, and producing questionnaire instrumentation.