Zelen's Design
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Zelen's Design
Zelen's design is an experimental design for randomized clinical trials proposed by Harvard School of Public Health statistician Marvin Zelen (1927-2014). In this design, patients are randomized to either the treatment or control group before giving informed consent. Because the group to which a given patient is assigned is known, consent can be sought conditionally. Overview In this design, those patients receiving standard care need not be consented for participation in the study other than possibly for privacy issues. On the other hand, those patients randomized to the experimental group are consented as usual, except that they are consenting to the certainty of receiving the experimental treatment only; alternatively these patients can decline and receive the standard treatment instead. In comparison, the current predominant design is for consent to be solicited prior to randomization. That is, eligible patients are asked if they would agree to participate in the clinical tria ...
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Experimental Design
The design of experiments (DOE, DOX, or experimental design) is the design of any task that aims to describe and explain the variation of information under conditions that are hypothesized to reflect the variation. The term is generally associated with experiments in which the design introduces conditions that directly affect the variation, but may also refer to the design of quasi-experiments, in which natural conditions that influence the variation are selected for observation. In its simplest form, an experiment aims at predicting the outcome by introducing a change of the preconditions, which is represented by one or more independent variables, also referred to as "input variables" or "predictor variables." The change in one or more independent variables is generally hypothesized to result in a change in one or more dependent variables, also referred to as "output variables" or "response variables." The experimental design may also identify control variables that must be h ...
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Randomized Clinical Trials
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 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 'experimental' a ...
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Harvard School Of Public Health
The Harvard T.H. Chan School of Public Health is the public health school of Harvard University, located in the Longwood Medical Area of Boston, Massachusetts. The school grew out of the Harvard-MIT School for Health Officers, the nation's first graduate training program in population health, which was founded in 1913 and then became the Harvard School of Public Health in 1922. Harvard's T.H. Chan School of Public Health is currently ranked as the best school for public health in the world by both the ''Academic Ranking of World Universities'' and EduRank. It is also ranked as the second (tie) best public health school in the nation by '' U.S. News & World Report''. History Harvard's T.H. School of Public Health traces its origins to the Harvard-MIT School for Health Officers, which was founded in 1913. Harvard calls it "the nation's first graduate training program in public health." In 1922, the School for Health Officers became the Harvard School of Public Health. In 1946, it ...
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Statistician
A statistician is a person who works with theoretical or applied statistics. The profession exists in both the private and public sectors. It is common to combine statistical knowledge with expertise in other subjects, and statisticians may work as employees or as statistical consultants. Nature of the work According to the United States Bureau of Labor Statistics, as of 2014, 26,970 jobs were classified as ''statistician'' in the United States. Of these people, approximately 30 percent worked for governments (federal, state, or local). As of October 2021, the median pay for statisticians in the United States was $92,270. Additionally, there is a substantial number of people who use statistics and data analysis in their work but have job titles other than ''statistician'', such as actuaries, applied mathematicians, economist An economist is a professional and practitioner in the social science discipline of economics. The individual may also study, develop, and apply ...
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Marvin Zelen (biostatistician)
Marvin Zelen (June 21, 1927 – November 15, 2014) was Professor Emeritus of Biostatistics in the Department of Biostatistics at the Harvard T.H. Chan School of Public Health (HSPH), and Lemuel Shattuck Research Professor of Statistical Science (the first recipient). During the 1980s, Zelen chaired HSPH's Department of Biostatistics. Among colleagues in the field of statistics, he was widely known as a leader who shaped the discipline of biostatistics. He "transformed clinical trial research into a statistically sophisticated branch of medical research." Zelen was noted for his developing some of the statistical methods and study designs still used in clinical cancer trials, in which experimental drugs are tested for toxicity, effectiveness, and proper dosage. He introduced measures to ensure that data gathered from human trials would be as free as possible of errors and biases—measures that are now standard practice. Zelen helped transform clinical trial research into a w ...
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Scientific Control
A scientific control is an experiment or observation designed to minimize the effects of variables other than the independent variable (i.e. confounding variables). This increases the reliability of the results, often through a comparison between control measurements and the other measurements. Scientific controls are a part of the scientific method. Controlled experiments Controls eliminate alternate explanations of experimental results, especially experimental errors and experimenter bias. Many controls are specific to the type of experiment being performed, as in the molecular markers used in SDS-PAGE experiments, and may simply have the purpose of ensuring that the equipment is working properly. The selection and use of proper controls to ensure that experimental results are valid (for example, absence of confounding variables) can be very difficult. Control measurements may also be used for other purposes: for example, a measurement of a microphone's background noise in ...
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Informed Consent
Informed consent is a principle in medical ethics and medical law, that a patient must have sufficient information and understanding before making decisions about their medical care. Pertinent information may include risks and benefits of treatments, alternative treatments, the patient's role in treatment, and their right to refuse treatment. In most systems, healthcare providers have a legal and ethical responsibility to ensure that a patient's consent is informed. This principle applies more broadly than healthcare intervention, for example to conduct research and to disclosing a person's medical information. Definitions of informed consent vary, and the standard required is generally determined by the state. Informed consent requires a clear appreciation and understanding of the facts, implications, and consequences of an action. To give informed consent, the individual concerned must have adequate reasoning faculties and possess all relevant facts. Impairments to reasoning an ...
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Resentful Demoralization
Resentful demoralization is an issue in controlled experiments in which those in the control group become resentful of not receiving the experimental treatment. Alternatively, the experimental group could be resentful of the control group, if the experimental group perceive its treatment as inferior. They may become angry, depressed, uncooperative, or non- compliant. This may lead to significant systematic differences in the outcome of the control group, obscuring the results of the study and threatening their validity. See also * Clinical trial * 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 te ... External linksResentful Demoralizationin Encyclopedia of Statistics in Behavioral Science. (subscription required) Design of experiments {{sociology-stu ...
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Hawthorne Effect
The Hawthorne effect is a type of reactivity in which individuals modify an aspect of their behavior in response to their awareness of being observed. The effect was discovered in the context of research conducted at the Hawthorne Western Electric plant; however, some scholars feel the descriptions are apocryphal. The original research involved workers who made electrical relays at the Hawthorne Works, a Western Electric plant in Cicero, Illinois. Between 1924 and 1927, the lighting study was conducted. Workers experienced a series of lighting changes in which productivity was said to increase with almost any change in the lighting. This turned out ''not'' to be true. In the study that was associated with Elton Mayo, which ran from 1928 to 1932, a series of changes in work structure were implemented (e.g., changes in rest periods) in a group of five women. However, this was a methodologically poor, uncontrolled study that did not permit any firm conclusions to be drawn. One of ...
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Cluster Randomised Controlled Trial
A cluster-randomised controlled trial is a type of randomised controlled trial in which groups of subjects (as opposed to individual subjects) are randomised. Cluster randomised controlled trials are also known as cluster-randomised trials, group-randomised trials, and place-randomized trials. Cluster-randomised controlled trials are used when there is a strong reason for randomising treatment and control groups over randomising participants. Prevalence A 2004 Bibliometrics, bibliometric study documented an increasing number of publications in the medical literature on cluster-randomised controlled trials since the 1980s. Advantages Advantages of cluster-randomised controlled trials over individually randomised controlled trials include: * The ability to study interventions that cannot be directed toward selected individuals (e.g., a radio show about lifestyle changes) and the ability to control for "contamination" across individuals (e.g., one individual's changing behaviors may ...
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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, ...
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Statistics
Statistics (from German language, German: ''wikt:Statistik#German, Statistik'', "description of a State (polity), state, a country") is the discipline that concerns the collection, organization, analysis, interpretation, and presentation of data. In applying statistics to a scientific, industrial, or social problem, it is conventional to begin with a statistical population or a statistical model to be studied. Populations can be diverse groups of people or objects such as "all people living in a country" or "every atom composing a crystal". Statistics deals with every aspect of data, including the planning of data collection in terms of the design of statistical survey, surveys and experimental design, experiments.Dodge, Y. (2006) ''The Oxford Dictionary of Statistical Terms'', Oxford University Press. When census data cannot be collected, statisticians collect data by developing specific experiment designs and survey sample (statistics), samples. Representative sampling as ...
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