Single-Subject Design
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Internal Validity Is About Causal Interpretability
Internal Validity is about Causal Interpretability Before we can discuss Internal Validity, we have to discuss different types of Internal Validity variables and review causal RH:s and the evidence needed to support them… Every behavior/measure used in a research study is either a ... Constant -- all the participants in the study have the same value on that behavior/measure or a ... • Measured & Manipulated Variables & Constants Variable -- when at least some of the participants in the study • Causes, Effects, Controls & Confounds have different values on that behavior/measure • Components of Internal Validity • “Creating” initial equivalence and every behavior/measure is either … • “Maintaining” ongoing equivalence Measured -- the value of that behavior/measure is obtained by • Interrelationships between Internal Validity & External Validity observation or self-report of the participant (often called “subject constant/variable”) or it is … Manipulated -- the value of that behavior/measure is controlled, delivered, determined, etc., by the researcher (often called “procedural constant/variable”) So, every behavior/measure in any study is one of four types…. constant variable measured measured (subject) measured (subject) constant variable manipulated manipulated manipulated (procedural) constant (procedural) variable Identify each of the following (as one of the four above, duh!)… • Participants reported practicing between 3 and 10 times • All participants were given the same set of words to memorize • Each participant reported they were a Psyc major • Each participant was given either the “homicide” or the “self- defense” vignette to read From before... Circle the manipulated/causal & underline measured/effect variable in each • Causal RH: -- differences in the amount or kind of one behavior cause/produce/create/change/etc. -
Comorbidity Scores
Bias Introduction of issue and background papers Sebastian Schneeweiss, MD, ScD Professor of Medicine and Epidemiology Division of Pharmacoepidemiology and Pharmacoeconomics, Dept of Medicine, Brigham & Women’s Hospital/ Harvard Medical School 1 Potential conflicts of interest PI, Brigham & Women’s Hospital DEcIDE Center for Comparative Effectiveness Research (AHRQ) PI, DEcIDE Methods Center (AHRQ) Co-Chair, Methods Core of the Mini Sentinel System (FDA) Member, national PCORI Methods Committee No paid consulting or speaker fees from pharmaceutical manufacturers Consulting in past year: . WHISCON LLC, Booz&Co, Aetion Investigator-initiated research grants to the Brigham from Pfizer, Novartis, Boehringer-Ingelheim Multiple grants from NIH 2 Objective of Comparative Effectiveness Research Efficacy Effectiveness* (Can it work?) (Does it work in routine care?) Placebo Most RCTs comparison for drug (or usual care) approval Active Goal of comparison (head-to-head) CER Effectiveness = Efficacy X Adherence X Subgroup effects (+/-) RCT Reality of routine care 3 * Cochrane A. Nuffield Provincial Trust, 1972 CER Baseline Non- randomization randomized Primary Secondary Primary Secondary data data data data 4 Challenges of observational research Measurement /surveillance-related biases . Informative missingness/ misclassification Selection-related biases . Confounding . Informative treatment changes/discontinuations Time-related biases . Immortal time bias . Temporality . Effect window (Multiple comparisons) 5 Informative missingness: -
Experimental Design
UNIVERSITY OF BERGEN Experimental design Sebastian Jentschke UNIVERSITY OF BERGEN Agenda • experiments and causal inference • validity • internal validity • statistical conclusion validity • construct validity • external validity • tradeoffs and priorities PAGE 2 Experiments and causal inference UNIVERSITY OF BERGEN Some definitions a hypothesis often concerns a cause- effect-relationship PAGE 4 UNIVERSITY OF BERGEN Scientific revolution • discovery of America → french revolution: renaissance and enlightenment – Copernicus, Galilei, Newton • empiricism: use observation to correct errors in theory • scientific experimentation: taking a deliberate action [manipulation, vary something] followed by systematic observation of what occured afterwards [effect] controlling extraneous influences that might limit or bias observation: random assignment, control groups • mathematization, institutionalization PAGE 5 UNIVERSITY OF BERGEN Causal relationships Definitions and some philosophy: • causal relationships are recognized intuitively by most people in their daily lives • Locke: „A cause is which makes any other thing, either simple idea, substance or mode, begin to be; and an effect is that, which had its beginning from some other thing“ (1975, p. 325) • Stuart Mill: A causal relationship exists if (a) the cause preceded the effect, (b) the cause was related to the effect, (c) we can find no plausible alternative explanantion for the effect other than the cause. Experiments: (a) manipulate the presumed cause, (b) assess whether variation in the -
Understanding Replication of Experiments in Software Engineering: a Classification Omar S
Understanding replication of experiments in software engineering: A classification Omar S. Gómez a, , Natalia Juristo b,c, Sira Vegas b a Facultad de Matemáticas, Universidad Autónoma de Yucatán, 97119 Mérida, Yucatán, Mexico Facultad de Informática, Universidad Politécnica de Madrid, 28660 Boadilla del Monte, Madrid, Spain c Department of Information Processing Science, University of Oulu, Oulu, Finland abstract Context: Replication plays an important role in experimental disciplines. There are still many uncertain-ties about how to proceed with replications of SE experiments. Should replicators reuse the baseline experiment materials? How much liaison should there be among the original and replicating experiment-ers, if any? What elements of the experimental configuration can be changed for the experiment to be considered a replication rather than a new experiment? Objective: To improve our understanding of SE experiment replication, in this work we propose a classi-fication which is intend to provide experimenters with guidance about what types of replication they can perform. Method: The research approach followed is structured according to the following activities: (1) a litera-ture review of experiment replication in SE and in other disciplines, (2) identification of typical elements that compose an experimental configuration, (3) identification of different replications purposes and (4) development of a classification of experiment replications for SE. Results: We propose a classification of replications which provides experimenters in SE with guidance about what changes can they make in a replication and, based on these, what verification purposes such a replication can serve. The proposed classification helped to accommodate opposing views within a broader framework, it is capable of accounting for less similar replications to more similar ones regarding the baseline experiment. -
Introduction to Difference in Differences (DID) Analysis
Introduction to Difference in Differences (DID) Analysis Hsueh-Sheng Wu CFDR Workshop Series June 15, 2020 1 Outline of Presentation • What is Difference-in-Differences (DID) analysis • Threats to internal and external validity • Compare and contrast three different research designs • Graphic presentation of the DID analysis • Link between regression and DID • Stata -diff- module • Sample Stata codes • Conclusions 2 What Is Difference-in-Differences Analysis • Difference-in-Differences (DID) analysis is a statistic technique that analyzes data from a nonequivalence control group design and makes a casual inference about an independent variable (e.g., an event, treatment, or policy) on an outcome variable • A non-equivalence control group design establishes the temporal order of the independent variable and the dependent variable, so it establishes which variable is the cause and which one is the effect • A non-equivalence control group design does not randomly assign respondents to the treatment or control group, so treatment and control groups may not be equivalent in their characteristics and reactions to the treatment • DID is commonly used to evaluate the outcome of policies or natural events (such as Covid-19) 3 Internal and External Validity • When designing an experiment, researchers need to consider how extraneous variables may threaten the internal validity and external validity of an experiment • Internal validity refers to the extent to which an experiment can establish the causal relation between the independent variable and -
Experimental Design and Data Analysis in Computer Simulation
Journal of Modern Applied Statistical Methods Volume 16 | Issue 2 Article 2 12-1-2017 Experimental Design and Data Analysis in Computer Simulation Studies in the Behavioral Sciences Michael Harwell University of Minnesota - Twin Cities, [email protected] Nidhi Kohli University of Minnesota - Twin Cities Yadira Peralta University of Minnesota - Twin Cities Follow this and additional works at: http://digitalcommons.wayne.edu/jmasm Part of the Applied Statistics Commons, Social and Behavioral Sciences Commons, and the Statistical Theory Commons Recommended Citation Harwell, M., Kohli, N., & Peralta, Y. (2017). Experimental Design and Data Analysis in Computer Simulation Studies in the Behavioral Sciences. Journal of Modern Applied Statistical Methods, 16(2), 3-28. doi: 10.22237/jmasm/1509494520 This Invited Article is brought to you for free and open access by the Open Access Journals at DigitalCommons@WayneState. It has been accepted for inclusion in Journal of Modern Applied Statistical Methods by an authorized editor of DigitalCommons@WayneState. Journal of Modern Applied Statistical Methods Copyright © 2017 JMASM, Inc. November 2017, Vol. 16, No. 2, 3-28. ISSN 1538 − 9472 doi: 10.22237/jmasm/1509494520 Experimental Design and Data Analysis in Computer Simulation Studies in the Behavioral Sciences Michael Harwell Nidhi Kohli Yadira Peralta University of Minnesota, University of Minnesota, University of Minnesota, Twin Cities Twin Cities Twin Cities Minneapolis, MN Minneapolis, MN Minneapolis, MN Treating computer simulation studies as statistical sampling experiments subject to established principles of experimental design and data analysis should further enhance their ability to inform statistical practice and a program of statistical research. Latin hypercube designs to enhance generalizability and meta-analytic methods to analyze simulation results are presented. -
Comparison of Response Surface Designs in a Spherical Region
World Academy of Science, Engineering and Technology International Journal of Mathematical and Computational Sciences Vol:6, No:5, 2012 Comparison of Response Surface Designs in a Spherical Region Boonorm Chomtee, John J. Borkowski Abstract—The objective of the research is to study and compare Where X is the design matrix, p is the number of model response surface designs: Central composite designs (CCD), Box- parameters, N is the design size, σ 2 is the maximum of Behnken designs (BBD), Small composite designs (SCD), Hybrid max designs, and Uniform shell designs (USD) over sets of reduced models f′′(x)( X X )−1 f (x) approximated over the set of candidate when the design is in a spherical region for 3 and 4 design variables. points. The values of the two criteria were calculated using The two optimality criteria ( D and G ) are considered which larger Matlab software [1]. values imply a better design. The comparison of design optimality criteria of the response surface designs across the full second order B. Reduced Models model and sets of reduced models for 3 and 4 factors based on the The set of reduced models is consistent with the definition two criteria are presented. of weak heredity given in Chipman [2]. That is, (i) a quadratic 2 Keywords—design optimality criteria, reduced models, response xi term is in the model only if the xi term is also in the model surface design, spherical design region and (ii) an interaction xi x j term is in the model only if the xi or x or both terms are also in the model. -
Single-Case Designs Technical Documentation
What Works Clearinghouse SINGLE‐CASE DESIGN TECHNICAL DOCUMENTATION Developed for the What Works Clearinghouse by the following panel: Kratochwill, T. R. Hitchcock, J. Horner, R. H. Levin, J. R. Odom, S. L. Rindskopf, D. M Shadish, W. R. June 2010 Recommended citation: Kratochwill, T. R., Hitchcock, J., Horner, R. H., Levin, J. R., Odom, S. L., Rindskopf, D. M & Shadish, W. R. (2010). Single-case designs technical documentation. Retrieved from What Works Clearinghouse website: http://ies.ed.gov/ncee/wwc/pdf/wwc_scd.pdf. 1 SINGLE-CASE DESIGNS TECHNICAL DOCUMENTATION In an effort to expand the pool of scientific evidence available for review, the What Works Clearinghouse (WWC) assembled a panel of national experts in single-case design (SCD) and analysis to draft SCD Standards. In this paper, the panel provides an overview of SCDs, specifies the types of questions that SCDs are designed to answer, and discusses the internal validity of SCDs. The panel then proposes SCD Standards to be implemented by the WWC. The Standards are bifurcated into Design and Evidence Standards (see Figure 1). The Design Standards evaluate the internal validity of the design. Reviewers assign the categories of Meets Standards, Meets Standards with Reservations and Does not Meet Standards to each study based on the Design Standards. Reviewers trained in visual analysis will then apply the Evidence Standards to studies that meet standards (with or without reservations), resulting in the categorization of each outcome variable as demonstrating Strong Evidence, Moderate Evidence, or No Evidence. A. OVERVIEW OF SINGLE-CASE DESIGNS SCDs are adaptations of interrupted time-series designs and can provide a rigorous experimental evaluation of intervention effects (Horner & Spaulding, in press; Kazdin, 1982, in press; Kratochwill, 1978; Kratochwill & Levin, 1992; Shadish, Cook, & Campbell, 2002). -
Relationships Between Sleep Duration and Adolescent Depression: a Conceptual Replication
HHS Public Access Author manuscript Author ManuscriptAuthor Manuscript Author Sleep Health Manuscript Author . Author manuscript; Manuscript Author available in PMC 2020 February 25. Published in final edited form as: Sleep Health. 2019 April ; 5(2): 175–179. doi:10.1016/j.sleh.2018.12.003. Relationships between sleep duration and adolescent depression: a conceptual replication AT Berger1, KL Wahlstrom2, R Widome1 1Division of Epidemiology and Community Health, University of Minnesota School of Public Health, 1300 South 2nd St, Suite #300, Minneapolis, MN 55454 2Department of Organizational Leadership, Policy and Development, 210D Burton Hall, College of Education and Human Development, University of Minnesota, Minneapolis, MN 55455 Abstract Objective—Given the growing concern about research reproducibility, we conceptually replicated a previous analysis of the relationships between adolescent sleep and mental well-being, using a new dataset. Methods—We conceptually reproduced an earlier analysis (Sleep Health, June 2017) using baseline data from the START Study. START is a longitudinal research study designed to evaluate a natural experiment in delaying high school start times, examining the impact of sleep duration on weight change in adolescents. In both START and the previous study, school day bedtime, wake up time, and answers to a six-item depression subscale were self-reported using a survey administered during the school day. Logistic regression models were used to compute the association and 95% confidence intervals (CI) between the sleep variables (sleep duration, wake- up time and bed time) and a range of outcomes. Results—In both analyses, greater sleep duration was associated with lower odds (P < 0.0001) of all six indicators of depressive mood. -
Internal Validity Page 1
Internal Validity page 1 Internal Validity If a study has internal validity, then you can be confident that the dependent variable was caused by the independent variable and not some other variable. Thus, a study with high internal validity permits conclusions of cause and effect. The major threat to internal validity is a confounding variable: a variable other than the independent variable that 1) often co-varies with the independent variable and 2) may be an alternative cause of the dependent variable. For example, if you want to investigate whether smoking cigarettes causes cancer, you will need to somehow control for other possible causes of cancer that tend to vary with smoking. Each of these other possible causes is a potential confounding variable. If people who smoke more also tend to experience greater stress, and stress is known to contribute to cancer, then stress could be a confounding variable. Not every variable that tends to co-vary with the independent variable is an equally plausible confounding variable. People who smoke may also strike more matches, but if striking matches is not plausibly linked to cancer in any way, then it is generally not worth considering as a serious threat to internal validity. Random assignment. The most common procedure to reduce the risk of confounding variables (and thus increase internal validity) is random assignment of participants to levels of the independent variable. This means that each participant in a study has an equal probability of being assigned to any of the levels of the independent variable. For the smoking study, random assignment would require some participants to be randomly assigned to smoke more than others. -
Topics in Experimental Design
Ronald Christensen Professor of Statistics Department of Mathematics and Statistics University of New Mexico Copyright c 2016 Topics in Experimental Design Springer Preface This (non)book assumes that the reader is familiar with the basic ideas of experi- mental design and with linear models. I think most of the applied material should be accessible to people with MS courses in regression and ANOVA but I had no hesi- tation in using linear model theory, if I needed it, to discuss more technical aspects. Over the last several years I’ve been working on revisions to my books Analysis of Variance, Design, and Regression (ANREG); Plane Answers to Complex Ques- tions: The Theory of Linear Models (PA); and Advanced Linear Modeling (ALM). In each of these books there was material that no longer seemed sufficiently relevant to the themes of the book for me to retain. Most of that material related to Exper- imental Design. Additionally, due to Kempthorne’s (1952) book, many years ago I figured out p f designs and wrote a chapter explaining them for the very first edition of ALM, but it was never included in any of my books. I like all of this material and think it is worthwhile, so I have accumulated it here. (I’m not actually all that wild about the recovery of interblock information in BIBs.) A few years ago my friend Chris Nachtsheim came to Albuquerque and gave a wonderful talk on Definitive Screening Designs. Chapter 5 was inspired by that talk along with my longstanding desire to figure out what was going on with Placett- Burman designs. -
Lecture 19: Causal Association (Kanchanaraksa)
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike License. Your use of this material constitutes acceptance of that license and the conditions of use of materials on this site. Copyright 2008, The Johns Hopkins University and Sukon Kanchanaraksa. All rights reserved. Use of these materials permitted only in accordance with license rights granted. Materials provided “AS IS”; no representations or warranties provided. User assumes all responsibility for use, and all liability related thereto, and must independently review all materials for accuracy and efficacy. May contain materials owned by others. User is responsible for obtaining permissions for use from third parties as needed. Causal Association Sukon Kanchanaraksa, PhD Johns Hopkins University From Association to Causation The following conditions have been met: − The study has an adequate sample size − The study is free of bias Adjustment for possible confounders has been done − There is an association between exposure of interest and the disease outcome Is the association causal? 3 Henle-Koch's Postulates (1884 and 1890) To establish a causal relationship between a parasite and a disease, all four must be fulfilled: 1. The organism must be found in all animals suffering from the disease—but not in healthy animals 2. The organism must be isolated from a diseased animal and grown in pure culture 3. The cultured organism should cause disease when introduced into a healthy animals 4. The organism must be re-isolated from the experimentally infected animal — Wikipedia Picture is from http://en.wikipedia.org/wiki/Robert_Koch 4 1964 Surgeon General’s Report 5 What Is a Cause? “The characterization of the assessment called for a specific term.