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Linguistic Validation
Linguistic validation is the process of investigating the reliability, conceptual equivalence, and content validityU.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH"Guidance for Industry - Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims"December 2009 of translations of patient-reported outcome (PRO) measures. Methodology Most usually, linguistic validation refers to a process whereby translated text is actively tested with patients in the target population and target language group through cognitive debriefing interviews. For example, if the PRO instrument is intended to measure the symptoms of diabetes in a trial in Denmark, the linguistic validation interviews would be conducted with diabetic patients in Denmark, who speak Danish as their mother tongue. Thi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Content Validity
In psychometrics, content validity (also known as logical validity) refers to the extent to which a measure represents all facets of a given construct. For example, a depression scale may lack content validity if it only assesses the affective dimension of depression but fails to take into account the behavioral dimension. An element of subjectivity exists in relation to determining content validity, which requires a degree of agreement about what a particular personality trait such as extraversion represents. A disagreement about a personality trait will prevent the gain of a high content validity. Description Content validity is different from face validity, which refers not to what the test actually measures, but to what it superficially appears to measure. Face validity assesses whether the test "looks valid" to the examinees who take it, the administrative personnel who decide on its use, and other technically untrained observers. Content validity requires the use of recogn ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Phrases
In syntax and grammar, a phrase is a group of words or singular word acting as a grammatical unit. For instance, the English expression "the very happy squirrel" is a noun phrase which contains the adjective phrase "very happy". Phrases can consist of a single word or a complete sentence. In theoretical linguistics, phrases are often analyzed as units of syntactic structure such as a constituent. Common and technical use There is a difference between the common use of the term ''phrase'' and its technical use in linguistics. In common usage, a phrase is usually a group of words with some special idiomatic meaning or other significance, such as "all rights reserved", "economical with the truth", "kick the bucket", and the like. It may be a euphemism, a saying or proverb, a fixed expression, a figure of speech, etc.. In linguistics, these are known as phrasemes. In theories of syntax, a phrase is any group of words, or sometimes a single word, which plays a particular role within t ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not d ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Back Translation
Translation is the communication of the meaning of a source-language text by means of an equivalent target-language text. The English language draws a terminological distinction (which does not exist in every language) between ''translating'' (a written text) and '' interpreting'' (oral or signed communication between users of different languages); under this distinction, translation can begin only after the appearance of writing within a language community. A translator always risks inadvertently introducing source-language words, grammar, or syntax into the target-language rendering. On the other hand, such "spill-overs" have sometimes imported useful source-language calques and loanwords that have enriched target languages. Translators, including early translators of sacred texts, have helped shape the very languages into which they have translated. Because of the laboriousness of the translation process, since the 1940s efforts have been made, with varying degree ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Methodology
In its most common sense, methodology is the study of research methods. However, the term can also refer to the methods themselves or to the philosophical discussion of associated background assumptions. A method is a structured procedure for bringing about a certain goal. In the context of research, this goal is usually to discover new knowledge or to verify pre-existing knowledge claims. This normally involves various steps, like choosing a sample, collecting data from this sample, and interpreting this data. The study of methods involves a detailed description and analysis of these processes. It includes evaluative aspects by comparing different methods to assess their advantages and disadvantages relative to different research goals and situations. This way, a methodology can help make the research process efficient and reliable by guiding researchers on which method to employ at each step. These descriptions and evaluations of methods often depend on philosophical background ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Value In Health
''Value in Health'' is a medical journal that covers original research and health policy articles in the field of health economics and outcomes research. The journal is published, on the behalf of ISPOR, by Elsevier Elsevier () is a Dutch academic publishing company specializing in scientific, technical, and medical content. Its products include journals such as ''The Lancet'', ''Cell'', the ScienceDirect collection of electronic journals, '' Trends'', th .... Abstracting and indexing The journal is abstracted and indexed in: * Current Contents - Social & Behavioral Sciences * Embase * PubMed/Medline * International Pharmaceutical Abstracts * Journal Citation Reports - Science Edition * Social Sciences Citation Index * PubMed/Medline References External links * Elsevier academic journals English-language journals Publications with year of establishment missing Healthcare journals {{med-journal-stub ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Value In Health
''Value in Health'' is a medical journal that covers original research and health policy articles in the field of health economics and outcomes research. The journal is published, on the behalf of ISPOR, by Elsevier Elsevier () is a Dutch academic publishing company specializing in scientific, technical, and medical content. Its products include journals such as ''The Lancet'', ''Cell'', the ScienceDirect collection of electronic journals, '' Trends'', th .... Abstracting and indexing The journal is abstracted and indexed in: * Current Contents - Social & Behavioral Sciences * Embase * PubMed/Medline * International Pharmaceutical Abstracts * Journal Citation Reports - Science Edition * Social Sciences Citation Index * PubMed/Medline References External links * Elsevier academic journals English-language journals Publications with year of establishment missing Healthcare journals {{med-journal-stub ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulatory
Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context. For example: * in biology, gene regulation and metabolic regulation allow living organisms to adapt to their environment and maintain homeostasis; * in government, typically regulation means stipulations of the delegated legislation which is drafted by subject-matter experts to enforce primary legislation; * in business, industry self-regulation occurs through self-regulatory organizations and trade associations which allow industries to set and enforce rules with less government involvement; and, * in psychology, self-regulation theory is the study of how individuals regulate their thoughts and behaviors to reach goals. Social Regulation in the social, political, psychological, and economic domains can take many forms: legal restriction ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Terminology
Terminology is a group of specialized words and respective meanings in a particular field, and also the study of such terms and their use; the latter meaning is also known as terminology science. A ''term'' is a word, compound word, or multi-word expressions that in specific contexts is given specific meanings—these may deviate from the meanings the same words have in other contexts and in everyday language. Terminology is a discipline that studies, among other things, the development of such terms and their interrelationships within a specialized domain. Terminology differs from lexicography, as it involves the study of concepts, conceptual systems and their labels (''terms''), whereas lexicography studies words and their meanings. Terminology is a discipline that systematically studies the "labelling or designating of concepts" particular to one or more subject fields or domains of human activity. It does this through the research and analysis of terms in context for the pu ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Patient-reported Outcome
A patient-reported outcome (PRO) is a health outcome directly reported by the patient who experienced it. It stands in contrast to an outcome reported by someone else, such as a physician-reported outcome, a nurse-reported outcome, and so on. PRO methods, such as questionnaires, are used in clinical trials or other clinical settings, to help better understand a treatment's efficacy or effectiveness. The use of digitized PROs, or electronic patient-reported outcomes (ePROs), is on the rise in today's health research setting. Terminology PROs should not be confused with PCOs, or '' patient-centered outcomes''. The latter implies the use of a questionnaire covering issues and concerns that are specific to a patient. Instead, ''patient-reported'' outcomes refers to reporting situations in which only the patient provides information related to a specific treatment or condition; this information may or may not be of concern to the patient. Further, PROs should not be confused with PREM ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Cognitive Debriefing
Cognition refers to "the mental action or process of acquiring knowledge and understanding through thought, experience, and the senses". It encompasses all aspects of intellectual functions and processes such as: perception, attention, thought, intelligence, the formation of knowledge, memory and working memory, judgment and evaluation, reasoning and computation, problem solving and decision making, comprehension and production of language. Imagination is also a cognitive process, it is considered as such because it involves thinking about possibilities. Cognitive processes use existing knowledge and discover new knowledge. Cognitive processes are analyzed from different perspectives within different contexts, notably in the fields of linguistics, musicology, anesthesia, neuroscience, psychiatry, psychology, education, philosophy, anthropology, biology, systemics, logic, and computer science. These and other approaches to the analysis of cognition (such as embodied cognition) a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Mother Tongue
A first language, native tongue, native language, mother tongue or L1 is the first language or dialect that a person has been exposed to from birth or within the critical period. In some countries, the term ''native language'' or ''mother tongue'' refers to the language or dialect of one's ethnic group rather than one's first language. The first language of a child is part of that child's personal, social and cultural identity. Another impact of the first language is that it brings about the reflection and learning of successful social patterns of acting and speaking. Research suggests that while a non-native speaker may develop fluency in a targeted language after about two years of immersion, it can take between five and seven years for that child to be on the same working level as their native speaking counterparts. On 17 November 1999, UNESCO designated 21 February as International Mother Language Day. Definitions One of the more widely accepted definitions of native spe ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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