Andrea M. Landis, PhD, RNUWLEAH – 2013
Discuss concepts important to researchdesignIdentifydifferent types of non-experimental, experimental, and quasi-experimental researchdesignsReview pertinent human subject issues related to adolescents
Research Design: Definition and Characteristics
The vehicle for hypothesis testing or answering research questionsA blueprint for conducting a studyMaximizes control over factors that could negatively effect the validity of study findingsGuides the researcher in planning and conducting a studyLinks the steps of the research process in the study
Concepts Important to Research Design
CausalityCause is not directly observable but must be observedThe cause is necessary for the effect to occurMulticausality– recognition that a number of interrelating variables can be involved in causing a particular effectProbability– Addresses the likelihood that something will happen in a given situationBiasTo slant away from the truth or the expectedFailing to consider or include both sides of the question or hypothesisControl– A check or comparison. Methods to keep the study conditions constant during the study
Forms of Control
Manipulation– Researcher exercises by specifying the IVElimination or Inclusion– Holding certain aspects of intervening and extraneous variables constantStatistical– Controlling extraneous variables by including them in the statistical analysisRandomization– Distribution of effects of extraneous variables via change with assignment of subjects to groups based on probabilityWhat is the difference between random sampling and random assignment?
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
Types of Research Designs
Non-experimental– both randomization and manipulation absentExperimental– both randomization and manipulation presentTrue or classic experimentQuasi-experimental– manipulation present, but not randomizationOne-group (pretest – posttest) design
Major Categories of Non-experimental Designs
DescriptiveDesigned to document conditions, attitudes, or characteristics of individuals or groupsExploratoryFocuses on the relationships among these factorsPredictiveAimed at the development of systems to predict criteria of interest by utilizing information from one or more predictorsExplanatoryAimed at testing of hypotheses formulated to explain phenomena of interest. Involves theoretical model testing.
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 surveyProspectiveVariables are measured through direct recording in the presentLongitudinalFollows a cohort of subjects over time, performing repeated measurements at prescribed intervalsCross-sectionalResearcher 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.
Perspectives in Qualitative Research Designs
PhenomenologySeeks to draw meaning of experiences through narrative subject materials. Words like “lived experience” often describe phenomenological studies.EthnographyStudy of the social milieu of a specific cultural group or people. Researcher often immersed in subject’s way of life.Grounded TheoryResearcher uses data to develop a theory that will explain what is observed. Researcher collects, codes, and analyzes data simultaneously.
Concerned with the study of the distribution of disease, injury, or dysfunction in human populationsObservational Epidemiologic StudiesGather 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 outcomesCase-control studies– groups of individuals are selected on the basis of whether they have the disorder under studyCohort studies– group of individuals followed over time to determine if they will develop a disorder
Nontraditional Designs: Examples
Methodological DesignsUsed to develop research approaches or the R/V of instruments to measure constructs used as variables in researchSecondary AnalysisStudying data previously collected in another studyMeta-Analysis DesignsInvolves merging findings from many studies that have examined the same phenomenon
Levels of Evidence
Challenges of Consenting Adolescents
Andrea M. Landis, PhD, RNAssistant ProfessorUW School of Nursing
Assent vs. Informed Consent
Assent: active affirmationof a desire toparticipate.Consent:mustbe 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 orphysicallyor mentally incapable of making informed decisions
Why are teens vulnerable?
Dramaticandrelatively rapidbiological changes, witha greatdeal of individual variation;An evolvingdevelopmental andcognitive maturity;Feelingsof lackingauthority andcontrol in healthcare settings; andDependenceon parents andhealthcare providersto makeinformed decisionsabout their care
What to keep in mind with this group?
Maintain a balancebetween scientificresponsibility andparticipantwelfare.Researchers mustconsider adolescents’decision-making and information-processing capacities.Differencesmay occurbased upon:particular situation (e.g., chronic condition,prior experiences, cognitivefunctioning andabilities)setting(e.g.,hospital vs. community).Assessing the risk of coercionis importantat 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.
What is the age range for moving from assent to consent?
Assent provides:informationin concrete,age-appropriate formattermsthatexplain thepurpose of the research, whatthe participantwill be asked to do,the proceduresthat will take place,andIdentifiesrisks and benefits ofparticipation.For childrenandadolescents 7–17years ofage.Manysocieties recognize age 18 as the age at which individuals are recognized and treated asadults.Pubertal changes duringadolescence arevariable in both timingand rate, and often not associatedwith chronologicalage.
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 toTo convey benefits:You may learn more about your….What we learn may help other kids….
What is the parent role in the consenting process?
Important things to remember:Obtainingan adolescent’sagreement toparticipate in a studyshould bedone separately fromconsent fromparents.Adolescents should beallowed to read (or be read to)the assent formin a roomapart fromtheir parents.Use ageanddevelopmentally 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) shouldreceivetheir own copy.At subsequent data collection points and visits, the adolescent should be given an opportunity to ask questions.
Any lessons learned from working with this group?
More than just signing forms.Adolescents need tobe active participantsin thedecision making process(e.g., assent/consent, knowledgeof the risks and benefits, etc.).Watch out for overt vs. subtle coercion.Your mom or dad said it is okay for you toparticipate…Great deal of individual variation, never assume.
How do you decide on study compensations?
Teen vs. parentHourly vs. stagesThis totals $___ if you do all the parts of the study.“To thank you for being in this study…”Gift card vs.$$Other compensation