Consecutive Controlled Case Series
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Consecutive Controlled Case Series
A consecutive controlled case series (CCCS) is a clinical study that involves aggregating multiple cases consecutively encountered wherein an experimentally controlled single-case experimental design was employed with each case. The CCCS design differs from the consecutive case series, because the latter reports on multiple cases where experimental control was not demonstrated, usually because a pre-post non experimental design was used. In contrast, a CCCS includes only cases where the intervention was evaluated using single-case experimental designs, such as a reversal design, where experimental control is demonstrated through the replication of treatment effects for each individual participant. Thus, the CCCS design has better internal validity than a consecutive case series. The CCCS design also address some concerns about the external validity or generality of findings of small-''n'' single-case experimental design studies because it explicitly includes all cases encountered, ...
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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 ** ...
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Single-subject Design
In design of experiments, single-subject curriculum or single-case research design is a research design most often used in applied fields of psychology, education, and human behaviour in which the subject serves as his/her own control, rather than using another individual/group. Researchers use single-subject design because these designs are sensitive to individual organism differences vs group designs which are sensitive to averages of groups. The logic behind single subject designs is 1) Prediction, 2) Verification, and 3) Replication. The baseline data predicts behaviour by affirming the consequent. Verification refers to demonstrating that the baseline responding would have continued had no intervention been implemented. Replication occurs when a previously observed behaviour changed is reproduced.Cooper, J. O., Heron, T. E., & Heward, W. L. (2007). Applied behavior analysis (2nd ed.). Columbus, OH: Merrill Prentice Hall. There can be large numbers of subjects in a research study ...
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Consecutive Case Series
A consecutive case series is a clinical study that includes all eligible patients identified by the researchers Research is "creative and systematic work undertaken to increase the stock of knowledge". It involves the collection, organization and analysis of evidence to increase understanding of a topic, characterized by a particular attentiveness t ... during the study registration period. The patients are treated in the order in which they are identified. This type of study usually does not have a control group. For example, in Sugrue, et al. (2016), a consecutive case series design was used to determine trends in hand surgery research.Sugrue, C.M., Joyce, C.W., Sugrue, R.M. and Carroll, S.M. (2016)TRENDS IN THE LEVEL OF EVIDENCE IN CLINICAL HAND SURGERY RESEARCH Hand (New York, N.Y.) 1558944715627619, first published on February 26, 2016 doi:10.1177/1558944715627619 References External links Consecutive case seriesentry in the public domain NCI Dictionary of Cance ...
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Internal Validity
Internal validity is the extent to which a piece of evidence supports a claim about cause and effect, within the context of a particular study. It is one of the most important properties of scientific studies and is an important concept in reasoning about evidence more generally. Internal validity is determined by how well a study can rule out alternative explanations for its findings (usually, sources of systematic error or 'bias'). It contrasts with external validity, the extent to which results can justify conclusions about other contexts (that is, the extent to which results can be generalized). Details Inferences are said to possess internal validity if a causal relationship between two variables is properly demonstrated.Shadish, W., Cook, T., and Campbell, D. (2002). Experimental and Quasi-Experimental Designs for Generilized Causal Inference Boston:Houghton Mifflin. A valid causal inference may be made when three criteria are satisfied: # the "cause" precedes the "eff ...
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External Validity
External validity is the validity of applying the conclusions of a scientific study outside the context of that study. In other words, it is the extent to which the results of a study can be generalized to and across other situations, people, stimuli, and times.Aronson, E., Wilson, T. D., Akert, R. M., & Fehr, B. (2007). Social psychology. (4 ed.). Toronto, ON: Pearson Education. In contrast, internal validity is the validity of conclusions drawn ''within'' the context of a particular study. Because general conclusions are almost always a goal in research, external validity is an important property of any study. Mathematical analysis of external validity concerns a determination of whether generalization across heterogeneous populations is feasible, and devising statistical and computational methods that produce valid generalizations. Threats "A threat to external validity is an explanation of how you might be wrong in making a generalization from the findings of a particular study ...
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Verification Bias
In statistics, verification bias is a type of measurement bias in which the results of a diagnostic test affect whether the gold standard procedure is used to verify the test result. This type of bias is also known as "work-up bias" or "referral bias". In clinical practice, verification bias is more likely to occur when a preliminary diagnostic test is negative. Because many gold standard tests can be invasive, expensive, and carry a higher risk (e.g. angiography, biopsy, surgery), patients and physicians may be more reluctant to undergo further work-up if a preliminary test is negative. In cohort studies A cohort study is a particular form of longitudinal study that samples a cohort (a group of people who share a defining characteristic, typically those who experienced a common event in a selected period, such as birth or graduation), performing ..., obtaining a gold standard test on every patient may not always be ethical, practical, or cost effective. These studies can thus b ...
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Good Clinical Practice
Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research. High standards are required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities, including computers and software. Quality assurance and inspections ensure that these standards are achieved. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented. GCP guidelines include protection of human rights for the subjects and volunteers in a clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. GCP guidelines include standards on how cl ...
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Single-subject Research
Single-subject research is a group of research methods that are used extensively in the experimental analysis of behavior and applied behavior analysis with both human and non-human participants. This research strategy focuses on one participant and tracks their progress in the research topic over a period of time. Single-subject research allows researchers to track changes in an individual over a large stretch of time instead of observing different people at different stages. This type of research can provide critical data in several fields, specifically psychology. It is most commonly used in experimental and applied analysis of behaviors. This research has been heavily debated over the years. Some believe that this research method is not effective at all while others praise the data that can be collected from it. Principal methods in this type of research are: A-B-A-B designs, Multi-element designs, Multiple Baseline designs, Repeated acquisition designs, Brief experimental desig ...
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Applied Behavior Analysis
Applied behavior analysis (ABA), also called behavioral engineering, is a psychological intervention that applies empirical approaches based upon the principles of respondent and operant conditioning to change behavior of social significance.See also footnote number "(1)" of nd the whole "What is ABA?" section of Where the same definition is given, (or quoted), and it credits (or mentions) both the source "Baer, Wolf & Risley, 1968" (Drs. Donald Baer, PhD, Montrose Wolf, PHD and Todd R. Risley, PhD, (Professor Emeritus of Psychology at the University of Alaska) were psychologists who developed science of applied behavior analysis) and ianother source, called "Sulzer-Azaroff & Mayer, 1991". Beth Sulzer-Azaroff is a psychologist at University of Massachusetts Amherst, Department of Psychology It is the applied form of behavior analysis; the other two forms are radical behaviorism (or the philosophy of the science) and the experimental analysis of behavior (or basic experime ...
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