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Pragmatic Clinical Trial
A pragmatic clinical trial (PCT), sometimes called a practical clinical trial (PCT), is a clinical trial that focuses on correlation between treatments and outcomes in real-world health system practice rather than focusing on proving causative explanations for outcomes, which requires extensive deconfounding with inclusion and exclusion criteria so strict that they risk rendering the trial results irrelevant to much of real-world practice. Examples A typical example is that an anti-diabetic medication in the real world will often be used in people with (latent or apparent) diabetes-induced kidney problems, but if a study of its efficacy and safety excluded some subsets of people with kidney problems (to escape confounding), the study's results may not reflect well what will actually happen in broad practice. PCTs thus contrast with explanatory clinical trials, which focus more on causation through deconfounding. The pragmatic versus explanatory distinction is a spectrum or ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, pharmaceutical drug, drugs, medical nutrition therapy, 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 institutional review board, 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 experiment, pi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Average Treatment Effect
The average treatment effect (ATE) is a measure used to compare treatments (or interventions) in randomized experiments, evaluation of policy interventions, and medical trials. The ATE measures the difference in mean (average) outcomes between units assigned to the treatment and units assigned to the control. In a randomized trial (i.e., an experimental study), the average treatment effect can be estimated from a sample using a comparison in mean outcomes for treated and untreated units. However, the ATE is generally understood as a causal parameter (i.e., an estimate or property of a population) that a researcher desires to know, defined without reference to the study design or estimation procedure. Both observational studies and experimental study designs with random assignment may enable one to estimate an ATE in a variety of ways. The average treatment effect is under some conditions directly related to the partial dependence plot. General definition Originating from e ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Placebo
A placebo ( ) can be roughly defined as a sham medical treatment. Common placebos include inert tablets (like sugar pills), inert injections (like saline), sham surgery, and other procedures. Placebos are used in randomized clinical trials to test the efficacy of medical treatments. In a placebo-controlled trial, any change in the control group is known as the ''placebo response'', and the difference between this and the result of no treatment is the ''placebo effect''. Placebos in clinical trials should ideally be indistinguishable from so-called verum treatments under investigation, except for the latter's particular hypothesized medicinal effect. This is to shield test participants (with their consent) from knowing who is getting the placebo and who is getting the treatment under test, as patients' and clinicians' expectations of efficacy can influence results. The idea of a placebo effect was discussed in 18th century psychology, but became more prominent in the 20th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Molecular Biology
Molecular biology is a branch of biology that seeks to understand the molecule, molecular basis of biological activity in and between Cell (biology), cells, including biomolecule, biomolecular synthesis, modification, mechanisms, and interactions. Though cells and other microscopic structures had been observed in living organisms as early as the 18th century, a detailed understanding of the mechanisms and interactions governing their behavior did not emerge until the 20th century, when technologies used in physics and chemistry had advanced sufficiently to permit their application in the biological sciences. The term 'molecular biology' was first used in 1945 by the English physicist William Astbury, who described it as an approach focused on discerning the underpinnings of biological phenomena—i.e. uncovering the physical and chemical structures and properties of biological molecules, as well as their interactions with other molecules and how these interactions explain observ ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Effectiveness
Effectiveness or effectivity is the capability of producing a desired result or the ability to produce desired output. When something is deemed effective, it means it has an intended or expected outcome, or produces a deep, vivid impression. Etymology The origin of the word ''effective'' stems from the Latin word , which means "creative, productive, or effective". It surfaced in Middle English between 1300 and 1400 AD. Usage Science and technology Mathematics and logic In mathematics and logic, ''effective'' is used to describe metalogical methods that fit the criteria of an effective procedure. In group theory, a group element acts ''effectively'' (or ''faithfully'') on a point, if that point is not fixed by the action. Physics In physics, an effective theory is, similar to a phenomenological theory, a framework intended to explain certain (observed) effects without the claim that the theory correctly models the underlying (unobserved) processes. In heat ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Comparative Effectiveness Research
Comparative effectiveness research (CER) is the direct comparison of existing health care interventions to determine which work best for which patients and which pose the greatest benefits and harms. The core question of comparative effectiveness research is which treatment works best, for whom, and under what circumstances. Engaging various stakeholders in this process, while difficult, makes research more applicable through providing information that improves patient decision making. The Institute of Medicine committee has defined CER as "the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The purpose of CER is to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels." Comparative effectiveness research adopts many of the same ap ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pragmatism
Pragmatism is a philosophical tradition that views language and thought as tools for prediction, problem solving, and action, rather than describing, representing, or mirroring reality. Pragmatists contend that most philosophical topics—such as the nature of knowledge, language, concepts, meaning, belief, and science—are best viewed in terms of their practical uses and successes. Pragmatism began in the United States in the 1870s. Its origins are often attributed to philosophers Charles Sanders Peirce, William James and John Dewey. In 1878, Peirce described it in his pragmatic maxim: "Consider the practical effects of the objects of your conception. Then, your conception of those effects is the whole of your conception of the object."Peirce, C.S. (1878), " How to Make Our Ideas Clear", ''Popular Science Monthly'', v. 12, 286–302. Reprinted often, including ''Collected Papers'' v. 5, paragraphs 388–410 and ''Essential Peirce'' v. 1, 124–141. See end of §II for ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Randomized Controlled Trial
A randomized controlled trial (or randomized control trial; RCT) is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures, diets or other medical treatments. Participants who enroll in RCTs differ from one another in known and unknown ways that can influence study outcomes, and yet cannot be directly controlled. By randomly allocating participants among compared treatments, an RCT enables ''statistical control'' over these influences. Provided it is designed well, conducted properly, and enrolls enough participants, an RCT may achieve sufficient control over these confounding factors to deliver a useful comparison of the treatments studied. Definition and examples An RCT in clinical research typically compares a proposed new treatment against an existing standard of care; these are then termed the 'expe ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Study Design
Clinical study design is the formulation of clinical trials and other experiments, as well as observational studies, in medical research involving human beings and involving clinical aspects, including epidemiology . It is the design of experiments as applied to these fields. The goal of a clinical study is to assess the safety, efficacy, and / or the mechanism of action of an investigational medicinal product (IMP) or procedure, or new drug or device that is in development, but potentially not yet approved by a health authority (e.g. Food and Drug Administration). It can also be to investigate a drug, device or procedure that has already been approved but is still in need of further investigation, typically with respect to long-term effects or cost-effectiveness. Some of the considerations here are shared under the more general topic of design of experiments but there can be others, in particular related to patient confidentiality and medical ethics. Outline of types of design ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Randomized Experiment
In scientific method, science, randomized experiments are the experiments that allow the greatest reliability and validity of statistical estimates of treatment effects. Randomization-based inference is especially important in experimental design and in survey sampling. Overview In the statistical theory of design of experiments, randomization involves randomly allocating the experimental units across the treatment groups. For example, if an experiment compares a new drug against a standard drug, then the patients should be allocated to either the new drug or to the standard drug control using randomization. Randomized experimentation is ''not'' haphazard. Randomization reduces bias by equalising other factors that have not been explicitly accounted for in the experimental design (according to the law of large numbers). Randomization also produces ignorability, ignorable designs, which are valuable in statistical model, model-based statistical inference, especially Bayesian infe ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Health Policy
Health policy can be defined as the "decisions, plans, and actions that are undertaken to achieve specific healthcare goals within a society".World Health Organization''Health Policy'' accessed 22 March 2011(archived 5 February 2011) According to the World Health Organization, an explicit health policy can achieve several things: it defines a vision for the future; it outlines priorities and the expected roles of different groups; and it builds consensus and informs people. Different approaches Health policy often refers to the health-related content of a policy. Understood in this sense, there are many categories of health policies, including global health policy, public health policy, mental health policy, health care services policy, insurance policy, personal healthcare policy, pharmaceutical policy, and policies related to public health such as vaccination policy, tobacco control policy or breastfeeding promotion policy. Health policy may also cover topics related to ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Guideline
A medical guideline (also called a clinical guideline, standard treatment guideline, or clinical practice guideline) is a document with the aim of guiding decisions and criteria regarding diagnosis, management, and treatment in specific areas of healthcare. Such documents have been in use for thousands of years during the entire history of medicine. However, in contrast to previous approaches, which were often based on tradition or authority, modern medical guidelines are based on an examination of current evidence within the paradigm of evidence-based medicine. They usually include summarized consensus statements on best practice in healthcare. A healthcare provider is obliged to know the medical guidelines of their profession, and has to decide whether to follow the recommendations of a guideline for an individual treatment. Background Modern clinical guidelines identify, summarize and evaluate the highest quality evidence and most current data about prevention, diagnosis, pr ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
