Andrea M. Landis, PhD, RN UW LEAH 2013 Research Design
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Learning Objectives Discuss concepts important to research
design Identify different types of non-experimental, experimental,
and quasi-experimental research designs Review pertinent human
subject issues related to adolescents
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Research Design: Definition and Characteristics The vehicle for
hypothesis testing or answering research questions A blueprint for
conducting a study Maximizes control over factors that could
negatively effect the validity of study findings Guides the
researcher in planning and conducting a study Links the steps of
the research process in the study
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Concepts Important to Research Design Causality Cause is not
directly observable but must be observed The cause is necessary for
the effect to occur Multicausality recognition that a number of
interrelating variables can be involved in causing a particular
effect Probability Addresses the likelihood that something will
happen in a given situation Bias To slant away from the truth or
the expected Failing to consider or include both sides of the
question or hypothesis Control A check or comparison. Methods to
keep the study conditions constant during the study
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Forms of Control Manipulation Researcher exercises by
specifying the IV Elimination or Inclusion Holding certain aspects
of intervening and extraneous variables constant Statistical
Controlling extraneous variables by including them in the
statistical analysis Randomization Distribution of effects of
extraneous variables via change with assignment of subjects to
groups based on probability What is the difference between random
sampling and random assignment?
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Concepts Important to Research Design Study Validity truth or
accuracy of the study findings. Internal Validity extent to which
the effects detected in the study are a true reflection of reality.
External Validity extent to which the findings of the study can be
generalized to the general population
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Types of Research Designs Non-experimental both randomization
and manipulation absent Experimental both randomization and
manipulation present True or classic experiment Quasi-experimental
manipulation present, but not randomization One-group (pretest
posttest) design
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Major Categories of Non-experimental Designs Descriptive
Designed to document conditions, attitudes, or characteristics of
individuals or groups Exploratory Focuses on the relationships
among these factors Predictive Aimed at the development of systems
to predict criteria of interest by utilizing information from one
or more predictors Explanatory Aimed at testing of hypotheses
formulated to explain phenomena of interest. Involves theoretical
model testing.
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Methods of Non-Experimental Research Retrospective (ex post
facto) Involves examining data that have been collected in the
past, often obtained from medical records or survey Prospective
Variables are measured through direct recording in the present
Longitudinal Follows a cohort of subjects over time, performing
repeated measurements at prescribed intervals Cross-sectional
Researcher studies a stratified group of subjects at one point in
time and draws conclusions about development within a population by
comparing the characteristics of those strata.
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Perspectives in Qualitative Research Designs Phenomenology
Seeks to draw meaning of experiences through narrative subject
materials. Words like lived experience often describe
phenomenological studies. Ethnography Study of the social milieu of
a specific cultural group or people. Researcher often immersed in
subjects way of life. Grounded Theory Researcher uses data to
develop a theory that will explain what is observed. Researcher
collects, codes, and analyzes data simultaneously.
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Epidemiological Research Concerned with the study of the
distribution of disease, injury, or dysfunction in human
populations Observational Epidemiologic Studies Gather measures
about disease frequency: prevalence (existing cases), incidence
(new cases) Analytic Epidemiologic Used when enough is known about
a condition to allow testing of hypotheses about the association of
specific risk factors (exposures) and outcomes Case-control studies
groups of individuals are selected on the basis of whether they
have the disorder under study Cohort studies group of individuals
followed over time to determine if they will develop a
disorder
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Nontraditional Designs: Examples Methodological Designs Used to
develop research approaches or the R/V of instruments to measure
constructs used as variables in research Secondary Analysis
Studying data previously collected in another study Meta-Analysis
Designs Involves merging findings from many studies that have
examined the same phenomenon
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Levels of Evidence
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Challenges of Consenting Adolescents Andrea M. Landis, PhD, RN
Assistant Professor UW School of Nursing
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Assent vs. Informed Consent Assent: active affirmation of a
desire to participate. Consent: must be voluntary and based upon
adequate knowledge of the purpose, risks, and potential benefits of
a research study. Individuals who do not have the authority to
consent to participate in research must still provide their assent.
minors or physically or mentally incapable of making informed
decisions
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Why are teens vulnerable? Dramatic and relatively rapid
biological changes, with a great deal of individual variation; An
evolving developmental and cognitive maturity; Feelings of lacking
authority and control in healthcare settings; and Dependence on
parents and healthcare providers to make informed decisions about
their care
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What to keep in mind with this group? Maintain a balance
between scientific responsibility and participant welfare.
Researchers must consider adolescents decision-making and
information-processing capacities. Differences may occur based
upon: particular situation (e.g., chronic condition, prior
experiences, cognitive functioning and abilities) setting (e.g.,
hospital vs. community). Assessing the risk of coercion is
important at any chronological age, but especially important for
adolescent participants. Being in research is your choice. You can
say Yes or NO. Either way is OK.
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What is the age range for moving from assent to consent? Assent
provides: information in concrete, age-appropriate format terms
that explain the purpose of the research, what the participant will
be asked to do, the procedures that will take place, and Identifies
risks and benefits of participation. For children and adolescents
717 years of age. Many societies recognize age 18 as the age at
which individuals are recognized and treated as adults. Pubertal
changes during adolescence are variable in both timing and rate,
and often not associated with chronological age.
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What wording/language works best to convey risks/benefits in
this group? To convey risks: You may get tired, The activity
monitor may rub like You may feel embarrassed during You do not
have to answer any question you do not want to To convey benefits:
You may learn more about your. What we learn may help other
kids.
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What is the parent role in the consenting process? Important
things to remember: Obtaining an adolescents agreement to
participate in a study should be done separately from consent from
parents. Adolescents should be allowed to read (or be read to) the
assent form in a room apart from their parents. Use age and
developmentally appropriate strategies (larger font; illustrated).
Reassure the teen that the information they provide will be
protected and kept confidential (from parents).* Adults (consent)
and adolescents (assent) should receive their own copy. At
subsequent data collection points and visits, the adolescent should
be given an opportunity to ask questions.
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Any lessons learned from working with this group? More than
just signing forms. Adolescents need to be active participants in
the decision making process (e.g., assent/consent, knowledge of the
risks and benefits, etc.). Watch out for overt vs. subtle coercion.
Your mom or dad said it is okay for you to participate Great deal
of individual variation, never assume.
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How do you decide on study compensations? Teen vs. parent
Hourly vs. stages This totals $___ if you do all the parts of the
study. To thank you for being in this study Gift card vs. $$ Other
compensation