Statistics Pha 6300 Exam 1

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Representation or replica of a complex phenmenon typically communicated in a visual format. A representation of reality

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Model

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A set of assumptions, concepts, values, and practices that constitutes a way of viewing reality

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Paradigm

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Label for an abstract idea. A set of objects or events that share common characteristics and a common name.

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Concept

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Highly abstract concepts. Examples: anxiety, self-concept, leadership, ego strength

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Constructs

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Difference between constant data ans variable data

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constant - the characteristic is the same for every member of the group
variable - the characteristic takes different values for different members of the group under study

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If you give a questionaire to all the students in 6th grade, grade level (6th) would be constant or variable?

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constant

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If you give a questionaire to all the students in 6th grade, gender, month of birth, number of siblings, place of residence, favorite book would be constant or variable?

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variable

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Qualities, properties, and/or characteristics of persons, things or situations that are studied in research.

Concepts that have been concretely defined to facilitate observation or measurement within a study.

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Variables

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What are the types of research variables?

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Independent (I don't care anymore)
Dependent
Confounding
Attribute

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Stimulus or activity that is manipulated or varied by the reasearcher to create an effect on the dependent variable.

Can also be used to classify data.

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Independent Variable (Also called treatment or experimental variable)

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Refers to the response, behavior or outcome that the researcher wants to predict or explain.

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Dependent Variable (also called effect variable or criterion measure)

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Changes in the ____ variable are presumed to be caused by the ___ variable. They are measures of the effect of the ___ variable.

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Dependent, Independent, Independent

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Can affect the measurement of the study variables and examination of the relationships within a study.

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Confounding Variable (Extraneous, uncontrolled)

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Characteristics or elements of the human subject that are collected to describe the sample

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Attribute Variable also called demographic variables
Examples: age, gender, education level, income, race, socioeconomic status and job classification

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Operational definition is

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an explanation of how the variable will be measured

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Conceptual definition is

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broad, abstract meaning of a concept

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Operationalizing the Variables a process that involves the developement of

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conceptual definition and operational definition

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A Statistic category used to classify ans summarize numerical data (to describe data)

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descriptive statistics

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A statistic category that are procedures for making generalizations about a population by studying a sample from that population.

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Inferential Statistics

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Population or Universe is

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All members of a specified group (Ex: All P3's)

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Sample is

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A subset of a population (Ex: 50 students from the P3 group)

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Parameters are

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the characteristics of a population. Represented by GREEK letters.
Example: mean population = m (mu)

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ESTIMATES ARE

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the characteristics of a sample. Represented with ROMAN letters, ex: mean of sample = x with a line over it
ER

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We draw conclusions about characteristics of the ___ based on the corresponding characteristics of the ___.

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Population, Sample

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The general field of disciplined investigation. Systematic approach to identifying relationships of variables representing concepts AND/OR determining differences between or among groups in their standing on one or more variable of interest

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Research

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Name the types of Research

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Formal
Basic
Applied
Develpmental

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Refers to MATH and LOGIC, no practical application, researches theoretical concepts, not data (the objective is to clarify the theory), can develop a new theory

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Formal Research

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Gathers DATA, Develops new theory, no practical application (want to increase knowledge)

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Basic Research

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Applies a model or theory in the environment, can develop a NEW theory, (solve a problem)
Ex: how to treat or cure a disease

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Applied Research

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may be theory-driven but it DOESN'T RESULT IN A NEW THEORY
Example: study of whether a new smoking cessation program based on the Transtheroretical Model works (could be a product or a project)

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Develpmental Model - develpment of a project (or product)

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Where can you find a research topic?

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Self-analysis (personal interest area)
Interview experts
Literature Review
Reference Lists

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Name the types of Observational Studies

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Descriptive Studies and Analytic Studies

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Studies that focus on characterizing the occurrence of the condition or problem by person, place, or time variables. No a prioi hypotheses

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Descriptive Studies (FOCUS: Describe what exists)

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Unusual or rare conditions. Detailed description of interesting characteristics observed in an individual patient. Described in terms of person, place, time and other relevant variables

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Case Report

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Weakest Observational Study Design, cannot test hypotheses

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Case Report

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Advantages of case-series studies are

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It helps to generate hypotheses (observations may be useful to researchers designing a study to evaluate causes or explanations of the observations.

Easy to write

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Disadvantages of Case Series Studies are

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Susceptible to bias - subject selection, characteristics observed
Can't reach conclusions

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Analysis of data on a group of subjects at ONE point in time. What is happening right now?

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Cross-Sectional Study (prevalence study, surveys, epidemiologic study)

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Advantages of Cross-Sectional Studies

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Useful for determining the STATUS QUO of a disease or condition and evaluating diagnostic procedures

Relatively quick and inexpensive

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Disadvantage of Cross-Sectional Studies

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Only provides a "snapshot in time" of the disease or process, can result in misleading information

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Types of Analytic Studies

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Cross-Sectional
Ecologic
Multi-level analysis
Case Control
Cohort
Hybrid

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Analysis that focus on comparisons of groups.

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Ecologic or Aggregate Analysis The groups are derived from geographically defined areas or time periods (ECOLOGICAL UNIT).
The analysis combines existing datasets on these large populations

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The following examples are examples of _____
City, County, State, Country, Particular day, month, year, decade

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Ecologic

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Advantages of Ecologic analyses

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Quick, convenient, and inexpensive
Generate Hypotheses
Avoid some measurement limitations of individual-level studies
Ideal for evaluation of the population effect of public policies, programs and legislation

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The failure of the ecologic effect estimates to reflect biologic effects at the individual level

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Ecologic Fallacy - limitation of ecologic analyses

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Limitations of Ecologic Analyses

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Ecologic Fallacy
Restricted to available data
Overall correlations can mask important subgroups

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Individual-level analyses that incorporate some ECOLOGIC measurements

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Multi-level Analyses - help to assess if the individual's health is shaped by: group-level variables (family income) or population characteristics (population density)

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What is the primary objective of the analysis of cohort study data?

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To compare the occurrence of symptoms, disease, and death in the exposed and unexposed groups.

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The Exposed group in Cohort Studies is known as

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the index group

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The Unexposed group in Cohort Studies is known as

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referent or comparison group

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Occurs when, at a defined point in time in the study, all data collected to that point are analyzed so a decision can be made to stop or continue the study

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Midpoint analysis

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What are the types of population of cohort studies?

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Open, Closed, Fixed

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Subjects are allowed to enter the study at various times after it was started

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Open population of cohort studies

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No subjects can be added to the study after it has begun

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Closed population of cohort studies

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when the cohort is formed on the basis of an irrevocable event such as undergoing a medical procedure. The individual's exposure does not change over time.

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Fixed population of cohort studies

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The direction of this study is from outcome to risk factor/precursor (have illness, want to find out way)

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Case-Control

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The direction of this study is from risk factor/exposure to outcome (know they have risk factor and want to know what happens to those that are exposed)

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Cohort

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When subjects can no longer be located or when they no longer want to participate in a study.

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Attrition Bias (also called loss to follow up)

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What is Heterogeneity?

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Variation in results across studies due to chance, variations in patients and interventions, different outcome measures, methodological quality

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The percentage of variation across the studies cannot be attributed to chance. Measure of the magnitude of heterogeneity

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I^2 statistic

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Low heterogeneity

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< 25%

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Moderate heterogeneity

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25-75%

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High Heterogeneity

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> 75%

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Sources of Meta-Analyses

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Cochrane Handbook, Paper, CD-ROM, Internet

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Refers to the repeated performance of a meta-analysis in a chronological fashion

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Cumulative Meta-Analysis

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Cumulative Meta-Analysis is useful when:

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clear consensus does not exist and there is continuous generation of data

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Developed the ethical principles and guidelines for protection of human subjects participating on biomedical and behavioral research

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Belmont Report (1979)

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Name the 3 Basic Ethical Principles

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1. Respect for persons - (acknowledgement of authority and protection of those with diminish authority)
2. beneficence (do not harm, maximize possible benefits and minimize possible harm)
3. justice - "to each person an equal share"

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Who creates the institutional review board?

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Code of Federal Regulatons (title 45, part 46)
purpose is protection of human subjects Office for Human Research Protection OHRP

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Study design in which some intervention is performed

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Experimental Studies also called: intervention studies, trials

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what is the purpose of clinical trials?

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Draw conclusions about a particular procedure or treatment

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Research study design that involves applied settings where it is not possible to control and/or manipulate all the relevant variables but only some of them.

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Quasi-Experimental Research

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UNPLANNED situations in nature that resemble planned experiments. Relatively rare situation in nature

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Natural experiments
Ex: study of the heatlh effects of radiation exposure on poulations according to the distance from the disaster site

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Group where the subjects receive no intervention or one where they receive the standard or conventional intervention

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Control Group

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These trials have greater validity than uncontrolled trials

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controlled trials

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A method to control trials - have interventions for both groups for the same TIME PERIOD in the same study.

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Concurrent Control

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A method to control trials in which neither subjects nor investigators know whether the subject is in the treatment or the control group.

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Double - Blind trials

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A method to control trials when the subject is unaware of being in the treatment or in the control group

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Blind Trials

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Considered the Gold Standard because well designed and conducted, tight control of experimental conditions and randomization of the subjects

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Randomized Clinical Trials RCTs

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Name the types of Randomized Clinical Trials

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Preventive/Prophylactic trials
Intervention Trials
Therapeutic Trials

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The primary prevention of the randomized clinical trials

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Preventive/Prophylactic Trials - trials of vaccine efficacy on healthy volunteers

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The secondary prevention of the randomized clinical trials

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Intervention trials - trials of lipid lowering drugs in individuals at high risk of heart disease

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The tertiary prevention of the randomized clinical trials

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Therapeutic Trials - trials of the efficacy of various forms of therapy on survival of cancer patients

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One disadvantage of Randomized Clinical Trial is

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Expensive, Long duration, tendency of nonrandomized studies (historical controls) to show a positive outcome

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Studies that do not use randomized assignment. Considered weaker because they do not prevent bias in patient assignment

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Nonrandomized trials also called cliical trials or comparative studies

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Study that uses patients as their own controls
Ex: Patient who underwent cholecystectomy were followed up at 1 and 3 months after the procedure to detect changes

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Self-Controlled Study

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A limitation of the self-controlled study in which people change their behavior and sometimes improve simply because they receive special attention by being in a study and not because of the study intervention

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Hawthorne Effect

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A combination of concurrent and self-controlled studies

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Crossover Study
1. Start w/ 2 groups - experimental treatment and placebo/control treatment
2. "WASHOUT" period - No treatment
3. Groups receive alternative treatment - switch treatment between groups

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Test one hypothesis and allows examination of the effect of the intervention both within and between the two groups being compared

Advantages: reduced sample size and more statistical power
Disadvantages: longer duration, attrition rate, only for interventions that provide temporary relief, complex analysis

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Crossover Study

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Patients the investigator has previously treated in another manner. Used for incurable diseases, oncologic studies

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Historical Controls (certain factors may have changed since they were treated and may be responsible for differences, not the treatment.

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Type of study that is used more for procedures than for drugs

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Uncontrolled Trials - the investigators' experience with the experimental drug or procedure is described but not compared with another treatment not formally.

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Each entity from the population that is the ultimate sampling object

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sampling element

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the complete list of all units from which the sample is drawn

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sampling frame