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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 de confounding 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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trial
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 i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Decision-making
In psychology, decision-making (also spelled decision making and decisionmaking) is regarded as the Cognition, cognitive process resulting in the selection of a belief or a course of action among several possible alternative options. It could be either Rationality, rational or irrational. The decision-making process is a reasoning process based on assumptions of value (ethics and social sciences), values, preferences and beliefs of the decision-maker. Every decision-making process produces a final choice, which may or may not prompt action. Research about decision-making is also published under the label problem solving, particularly in European psychological research. Overview Decision-making can be regarded as a Problem solving, problem-solving activity yielding a solution deemed to be optimal, or at least satisfactory. It is therefore a process which can be more or less Rationality, rational or Irrationality, irrational and can be based on explicit knowledge, explicit or tacit ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Health Technology
Health technology is defined by the World Health Organization as the "application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures, and systems developed to solve a health problem and improve quality of lives". This includes pharmaceuticals, devices, procedures, and organizational systems used in the healthcare industry, as well as computer-supported information systems. In the United States, these technologies involve standardized physical objects, as well as traditional and designed social means and methods to treat or care for patients. Development Pre-digital Era During a pre-digital era, patients suffered from inefficient and faulty clinical systems, processes, and conditions. Many medical errors happened in the past due to undeveloped health technologies. Some examples of these medical errors included adverse drug events and alarm fatigue. Alarm fatigue is caused when an alarm is repeatedly triggered or activated and one becomes d ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 (medicine), 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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Molecular Biology
Molecular biology is the branch of biology that seeks to understand the molecular basis of biological activity in and between cells, including biomolecular synthesis, modification, mechanisms, and interactions. The study of chemical and physical structure of biological macromolecules is known as molecular biology. Molecular biology was first described as an approach focused on the underpinnings of biological phenomena - uncovering the structures of biological molecules as well as their interactions, and how these interactions explain observations of classical biology. In 1945 the term molecular biology was used by physicist William Astbury. In 1953 Francis Crick, James Watson, Rosalind Franklin, and colleagues, working at Medical Research Council unit, Cavendish laboratory, Cambridge (now the MRC Laboratory of Molecular Biology), made a double helix model of DNA which changed the entire research scenario. They proposed the DNA structure based on previous research done by Ro ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Effectiveness
Effectiveness 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 effectīvus, which means creative, productive or effective. It surfaced in Middle English between 1300 and 1400 A.D. Usage 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. 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 transfer, ''effectiveness'' is a measure of the performance of a heat exchange ... [...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 considers words and thought as tools and instruments for prediction, problem solving, and action, and rejects the idea that the function of thought is to describe, represent, or mirror reality. Pragmatists contend that most philosophical topics—such as the nature of knowledge, language, concepts, meaning, belief, and science—are all 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 the 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 an ... [...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 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 Random assignment, 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#Medical standard of care, ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Study Design
Clinical study design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research (e.g., epidemiological) involving human beings. 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 ethics. Outline of types of designs for clinical studies Treatment studies * Randomized controlled trial ** Blind trial ** ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Randomized Experiment
In 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 ignorable designs, which are valuable in model-based statistical inference, especially Bayesian or likelihood-based. In the design of experiments, th ... [...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(Web archive)/ref> 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 healthcar ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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