Andrea M. Landis, PhD, RN UW LEAH – 2013 Research Design

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

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

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

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?

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 absent Experimental – both randomization and manipulation present True or classic experiment Quasi-experimental – manipulation present, but not randomization One-group (pretest – posttest) design

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.

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.

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 subject’s 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.

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

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

Levels of Evidence

Challenges of Consenting Adolescents Andrea M. Landis, PhD, RN Assistant Professor UW School of Nursing

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

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

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.

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 7–17 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.

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….

What is the parent role in the consenting process? Important things to remember: Obtaining an adolescent’s 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.

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.

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