Unblinded Trial
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Unblinded Trial
In a blind or blinded experiment, information which may influence the participants of the experiment is withheld until after the experiment is complete. Good blinding can reduce or eliminate experimental biases that arise from a participants' expectations, observer's effect on the participants, observer bias, confirmation bias, and other sources. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. In some cases, while blinding would be useful, it is impossible or unethical. For example, it is not possible to blind a patient to their treatment in a physical therapy intervention. A good clinical protocol ensures that blinding is as effective as possible within ethical and practical constraints. During the course of an experiment, a participant becomes unblinded if they deduce or otherwise obtain information that has been masked to them. For example, a patient who experiences a side effect may corr ...
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Experiment
An experiment is a procedure carried out to support or refute a hypothesis, or determine the efficacy or likelihood of something previously untried. Experiments provide insight into Causality, cause-and-effect by demonstrating what outcome occurs when a particular factor is manipulated. Experiments vary greatly in goal and scale but always rely on repeatable procedure and logical analysis of the results. There also exist natural experiment, natural experimental studies. A child may carry out basic experiments to understand how things fall to the ground, while teams of scientists may take years of systematic investigation to advance their understanding of a phenomenon. Experiments and other types of hands-on activities are very important to student learning in the science classroom. Experiments can raise test scores and help a student become more engaged and interested in the material they are learning, especially when used over time. Experiments can vary from personal and in ...
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Friedrich Schiller
Johann Christoph Friedrich von Schiller (, short: ; 10 November 17599 May 1805) was a German playwright, poet, and philosopher. During the last seventeen years of his life (1788–1805), Schiller developed a productive, if complicated, friendship with the already famous and influential Johann Wolfgang von Goethe. They frequently discussed issues concerning aesthetics, and Schiller encouraged Goethe to finish works that he had left as sketches. This relationship and these discussions led to a period now referred to as Weimar Classicism. They also worked together on '' Xenien'', a collection of short satirical poems in which both Schiller and Goethe challenge opponents of their philosophical vision. Early life and career Friedrich Schiller was born on 10 November 1759, in Marbach, Württemberg, as the only son of military doctor Johann Kaspar Schiller (1733–1796) and Elisabetha Dorothea Schiller (1732–1802). They also had five daughters, including Christophine, the eldest. ...
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Code-break Procedure
A code-break procedure is a set of rules which determine when planned unblinding should occur in a blinded experiment In a blind or blinded experiment, information which may influence the participants of the experiment is withheld until after the experiment is complete. Good blinding can reduce or eliminate experimental biases that arise from a participants' expe .... FDA guidelines recommend that sponsors of blinded trials include a code-break procedure in their standard operating procedure. A code-break procedure should only allow a participant to be unblinded before the conclusion of a trial in the event of an emergency. Code-break usually refers to the unmasking of treatment allocation, but can refer to any form of unblinding. Traditionally, each patient's treatment allocation data was stored in a sealed envelopes, which was to be opened to break code. However, this system is prone to abuse. Reports of researchers opening envelopes prematurely or holding the envelopes up to l ...
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Treatment And Control Groups
In the design of experiments, hypotheses are applied to experimental units in a treatment group. In comparative experiments, members of a control group receive a standard treatment, a placebo, or no treatment at all. There may be more than one treatment group, more than one control group, or both. A placebo control group can be used to support a double-blind study, in which some subjects are given an ineffective treatment (in medical studies typically a sugar pill) to minimize differences in the experiences of subjects in the different groups; this is done in a way that ensures no participant in the experiment (subject or experimenter) knows to which group each subject belongs. In such cases, a third, non-treatment control group can be used to measure the placebo effect directly, as the difference between the responses of placebo subjects and untreated subjects, perhaps paired by age group or other factors (such as being twins). For the conclusions drawn from the results of an ...
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Clinical Studies
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary ...
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Hierarchy Of Evidence
A hierarchy of evidence (or levels of evidence) is a heuristic used to rank the relative strength of results obtained from scientific research. There is broad agreement on the relative strength of large-scale, epidemiological studies. More than 80 different hierarchies have been proposed for assessing medical evidence. The design of the study (such as a case report for an individual patient or a blinded randomized controlled trial) and the endpoints measured (such as survival or quality of life) affect the strength of the evidence. In clinical research, the best evidence for treatment efficacy is mainly from meta-analyses of randomized controlled trials (RCTs). Systematic reviews of completed, high-quality randomized controlled trials – such as those published by the Cochrane Collaboration – rank the same as systematic review of completed high-quality observational studies in regard to the study of side effects. Evidence hierarchies are often applied in evidence-based practic ...
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Choice Modeling
Choice modelling attempts to model the decision process of an individual or segment via revealed preferences or stated preferences made in a particular context or contexts. Typically, it attempts to use discrete choices (A over B; B over A, B & C) in order to infer positions of the items (A, B and C) on some relevant latent scale (typically "utility" in economics and various related fields). Indeed many alternative models exist in econometrics, marketing, sociometrics and other fields, including utility maximization, optimization applied to consumer theory, and a plethora of other identification strategies which may be more or less accurate depending on the data, sample, hypothesis and the particular decision being modelled. In addition, choice modelling is regarded as the most suitable method for estimating consumers' willingness to pay for quality improvements in multiple dimensions. Related terms There are a number of terms which are considered to be synonyms with the term cho ...
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Latent Variable
In statistics, latent variables (from Latin: present participle of ''lateo'', “lie hidden”) are variables that can only be inferred indirectly through a mathematical model from other observable variables that can be directly observed or measured. Such '' latent variable models'' are used in many disciplines, including political science, demography, engineering, medicine, ecology, physics, machine learning/artificial intelligence, bioinformatics, chemometrics, natural language processing, management and the social sciences. Latent variables may correspond to aspects of physical reality. These could in principle be measured, but may not be for practical reasons. In this situation, the term ''hidden variables'' is commonly used (reflecting the fact that the variables are meaningful, but not observable). Other latent variables correspond to abstract concepts, like categories, behavioral or mental states, or data structures. The terms ''hypothetical variables'' or ''hypothetica ...
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Placebo
A placebo ( ) is a substance or treatment which is designed to have no therapeutic value. Common placebos include inert tablets (like sugar pills), inert injections (like saline), sham surgery, and other procedures. In general, placebos can affect how patients perceive their condition and encourage the body's chemical processes for relieving pain and a few other symptoms, but have no impact on the disease itself. Improvements that patients experience after being treated with a placebo can also be due to unrelated factors, such as regression to the mean (a statistical effect where an unusually high or low measurement is likely to be followed by a less extreme one). The use of placebos in clinical medicine raises ethical concerns, especially if they are disguised as an active treatment, as this introduces dishonesty into the doctor–patient relationship and bypasses informed consent. While it was once assumed that this deception was necessary for placebos to have any effect, the ...
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Dichotomy
A dichotomy is a partition of a whole (or a set) into two parts (subsets). In other words, this couple of parts must be * jointly exhaustive: everything must belong to one part or the other, and * mutually exclusive: nothing can belong simultaneously to both parts. If there is a concept A, and it is split into parts B and not-B, then the parts form a dichotomy: they are mutually exclusive, since no part of B is contained in not-B and vice versa, and they are jointly exhaustive, since they cover all of A, and together again give A. Such a partition is also frequently called a bipartition. The two parts thus formed are complements. In logic, the partitions are opposites if there exists a proposition such that it holds over one and not the other. Treating continuous variables or multicategorical variables as binary variables is called dichotomization. The discretization error inherent in dichotomization is temporarily ignored for modeling purposes. Etymology The te ...
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Spectrum
A spectrum (plural ''spectra'' or ''spectrums'') is a condition that is not limited to a specific set of values but can vary, without gaps, across a continuum. The word was first used scientifically in optics to describe the rainbow of colors in visible light after passing through a prism. As scientific understanding of light advanced, it came to apply to the entire electromagnetic spectrum. It thereby became a mapping of a range of magnitudes (wavelengths) to a range of qualities, which are the perceived "colors of the rainbow" and other properties which correspond to wavelengths that lie outside of the visible light spectrum. Spectrum has since been applied by analogy to topics outside optics. Thus, one might talk about the " spectrum of political opinion", or the "spectrum of activity" of a drug, or the " autism spectrum". In these uses, values within a spectrum may not be associated with precisely quantifiable numbers or definitions. Such uses imply a broad range of cond ...
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Treatment And Control Groups
In the design of experiments, hypotheses are applied to experimental units in a treatment group. In comparative experiments, members of a control group receive a standard treatment, a placebo, or no treatment at all. There may be more than one treatment group, more than one control group, or both. A placebo control group can be used to support a double-blind study, in which some subjects are given an ineffective treatment (in medical studies typically a sugar pill) to minimize differences in the experiences of subjects in the different groups; this is done in a way that ensures no participant in the experiment (subject or experimenter) knows to which group each subject belongs. In such cases, a third, non-treatment control group can be used to measure the placebo effect directly, as the difference between the responses of placebo subjects and untreated subjects, perhaps paired by age group or other factors (such as being twins). For the conclusions drawn from the results of an ...
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