AH 4239 Exam 1 Material

Objectives (aka Aims or Goals)

•List Objectives by number •Should be measurable activities! •Link Hypotheses with Objectives

Steps in the Scientific Method

1. Background Research: be sure you are knowledgeable on this topic and ensure you know what has already been researched on this topic ('review of literature'). 2. Develop a question 3. Construct a hypothesis •Make predictions based on background research/previous studies 4. Design best methodology possible to test your hypothesis 5. Test your hypothesis using methods selected and collect your data 6. Use statistical analyses to analyze your data and make conclusions 7. Communicate results (publish in journals, present at conferences, communicate to general public)

Steps in Sampling Process

1. Identify Target (Reference) Population (Group of people to which researcher intends to generalize findings) 2. Identify Accessible Population (Some portion of target population that has a chance to be selected) 3. Choose a Sampling Procedure 4. Define Inclusion & Exclusion Criteria (if needed) •Example: •Study of Motor Skills: Target: All children with learning disabilities in the US today Accessible: All children with learning disability in a given city's school system Sample will be chosen from this accessible population

Criteria for IRB Approval

1. Risks to subjects are minimized 2. Risks to subjects are reasonable in relation to anticipated benefits and knowledge that may reasonably be expected to result from study 3. Selection of subjects is equitable 4. Informed consent will be sought from each participant 5. Informed consent will be appropriately documented 6. Monitoring of data collected to ensure participant safety (when appropriate) 7. Adequate provisions to protect privacy of subjects and maintain confidentiality of data •Additional provisions made for vulnerable populations: mentally disabled, pregnant women, children, prisoners, economically or educationally disadvantaged.

Probability Sampling

1. Simple Random Sampling (Equal Probability) E.g.: Therapists in an organization (2000 Therapists) --> Sample: 200 Therapists 2. Stratified Random Sampling (Subgroups or Strata) E.g.: Therapists in an organization (1000 Female, 1000 Male) --> Sample: 100F & 100M Therapists 3. Disproportionate Sampling (Subgroups or Strata) E.g.: Therapists in an organization (1700 Female, 300 Male) --> Sample: 100F & 100M Therapists 4. Cluster Sampling (Large & Dispersed Populations Multistage) E.g.: Therapists in the US (90,000 Therapists) --> Sample: 200 Therapists (Process: Select 5 states --> 10 Organizations in each --> 4 Therapists from each organization)

Control Group

A group against which the experimental group is compared: •Placebo •No intervention •Basis of comparison for a new intervention

Be a Critical Consumer of Research

Always consider following: •The Who? •Researchers, participants, consumers •The Where? •Research Setting • The Why? •Motivation • The How? •Methods, ethics All these factors can impact usefulness/ applicability of a study! Regardless of research goal (descriptive, predictive, etc.), it is imperative that we are critical consumers of science.

Goals of Behavioral Research

Behavioral research can have a variety of goals with each study focusing on at least one of the following specific goals: 1. Describing behavior Example: Determining whether college students prefer to communicate via text vs. email 2. Predicting behavior Anticipate future events Example: College students will respond to text messages quicker than they respond to emails. 3. Determining cause of behavior Example: College students respond quicker to texts than emails because they check their texts more often. 4. Explaining behavior Example: College students respond quicker to text than email because they check their texts more often, but why? College students find texting easier, enjoyable, practical, and a more immediate form of communication

Participant Characteristics

Consider characteristics (criteria) that you need your participants to meet in order to participate This will be different for each study depending on what is being researched and will impact type of sampling method selected •Greater number of criteria you have, greater control you will have in your study. However, this also leads to changes in generalizability of your results: they are more restricted since the population is more specific. Inclusion Criteria: Primary characteristics of target and accessible populations that will qualify someone as a participant. Exclusion Criteria: Characteristics that would prevent someone from being a participant. Example: Physical therapy to reduce back pain in adults ages 60-80? •Inclusion: age, back pain •Exclusion: pain medications, other therapies, age (<60; >80)

How to Control for Confounds part 2

Control Group A group against which experimental group is compared to: •Placebo or no intervention •Basis of comparison for a new intervention Random Assignment Each subject has an equal chance of being assigned to any group. ●Pro: No personal judgment or bias ●Con: Groups not balanced on important variables

Recent Ethical Violations

Dan Markingson: •26 y.o. Graduate Student at Univ. of Michigan •Started showing signs of mental illness in early 2003 •Paranoia, thoughts of harming others •Psychiatrist recommended he be involuntarily committed (with court agreement) •Recruited to clinical trial despite objections from mother at Univ. of Minnesota-AstraZeneca •CAFÉ Study (Comparison of Atypicals in First-Episode Schizophrenia) •Committed suicide while enrolled in randomized clinical trial •Mother complained numerous times and wrote letters to study coordinator about violent behavior •Dan lacked capacity to provide informed consent •Consent failed to disclose serious risks to patients •Targeted vulnerable subjects •Investigator failed to disclose financial interests •Department of Psychiatry was paid over $15,000 per subject who completed study •Study Coordinator given responsibilities she was not qualified for •Enrolled someone who was in danger to himself/others. Mom clearly expressed concern that his 'meds were not working', he was 'out of control', and asks whether 'we have to wait until he kills himself or someone else before anyone does anything'.

Descriptive Research 2

Describes nature of existing phenomena 1. Case Studies: (e.g. studying one participant with symptoms of an unknown condition.), to develop a clinical knowledge base. 2. Developmental Research: to describe a developmental change in people over time. a. Longitudinal Method: follows 1 cohort (group) of participants for many years, taking measurements throughout study. b. Cross-Sectional Method: follows two or more cohorts, takes one measurement (less expensive & immediate results) c. Sequential Methods (a + b)

Random Assignment (not to be confused with random sampling)

Each subject has an equal chance of being assigned to any group (experimental or control group(s)). •Pro: No personal judgment or bias •Con: Groups not balanced on important variables (unintentionally skewed) Example: Compare effects of 2 exercises for strengthening knee extensors against a control group that receives no exercise - participants would be randomly assigned to one of the experimental groups or to control group

Hypotheses

Expected Findings ('educated guess') •Example Question (correlational): What is relationship between saturated fat intake and total cholesterol levels in men 70-80 y.o.? •Purpose: To determine relationship between saturated fat intake and total cholesterol levels in men 70-80 y.o. (Note: purpose is a statement form of research question) •Objective: Determine consumption of saturated fat using 5-day food records and total cholesterol levels of men 70-80 y.o. •Hypothesis: There will be a significant positive relationship between consumption of saturated fat and total cholesterol levels in men 70-80 y.o. Note: Most studies will have 2 or more objectives and hypotheses!

Example: Non-Exp. Epidemiological Study

Framingham Heart Study: Long-term cardiovascular cohort study on residents of Framingham Mass. that began in 1948 and is still ongoing. Study has helped identify the following list of risk factors for heart disease! According to CDC, 37% of adults report at least 2 of these risk factors for heart disease: Risk Factors for Heart Disease: •High Blood Pressure •High Cholesterol •Diabetes •Currently Smoking •Physical Inactivity •Obesity (CDC, 2003)

Why do we have an IRB?

Historically, there have been many ethical abuses... •Ethical Abuses - WWII, Nazi Germany Nazi Medical Experiments: •"Freezing experiments"- to find effective treatment for hypothermia •Tested immunization compounds and sera for prevention and treatment of contagious diseases (malaria, typhus, TB, typhoid fever, yellow fever, hepatitis). •Bone, muscle, nerve transplantation experiments •Exposure to phosgene and mustard gas to test antidotes •Diseases in different races •Experiments on twins: injecting dye into eyes, sewing twins together to create conjoined twins. •Sterilization experiments: X-rays, drugs, surgery

Protection of Human Subjects in Research

IRB: Committee that reviews research protocols to protect the rights and welfare of human participants. •Responsible for review of all human subject research •"Seeks to create a collaborative relationship with research community to assure research with human subjects is conducted in accordance with legal requirements and ethical principal of Respect for persons, Beneficence and Justice." - Office for the vice President for Research, University of Connecticut •Must balance risks and benefits to participants and society, and a gain of scientific knowledge

Correlation Coefficient

Indicated with a numerical index: Correlation Coefficient (R or r) •R/r ranges from -1 to +1: Shows "Strength" and "Direction" of relationship •R2 = % Variance/change in 'Y' accounted for by 'X' (0-100) (i.e.: how well 'X' can "predict" 'Y') •Third-Variable Problem: When % variance isn't 100%, it indicates that another variable not part of correlational study ('third variable') is likely accounting for remaining change seen in 'Y'. Example: Given output: r= .834 (what can you say about this value?) r2= 0.695 What is the percent variance (how well does 'X' predict 'Y'?) = 69.5% What does that mean? What amount of variability is left unaccounted for? 30.5% (what does this imply?)

Deception in Research

Investigators providing false or incomplete information to participants for purpose of misleading research subjects •IRB accepts need for certain types of studies to employ strategies that include deception. However, employment of such strategies must be justified. •In general, deception is not acceptable if, in judgment of IRB, the participant may have declined to participate had they been informed of the true purpose of research. This can be difficult to determine!

True Experimental Design

Key Features: •True Control Group •True Random Assignment •Groups are statistically equal Other Features: •Blind, Sample Size, Control Confounds •Pre-test / Post-test Design Example: Effects of resistance exercise on depressed elders. •Post-test Only Design Example: Researchers assessed patients undergoing elective hip/knee surgery to determine whether total cost and length of stay was different if rehabilitation began on postoperative day 3 vs. day 7. •Factorial Design: used for studies with more than one IV (or more than one level of IV) •Example: The effect of running vs. walking vs. no exercise on weight loss in middle aged men who are either on a low-fat diet or a normal diet? •IVs = Exercise (3 levels) and Diet (2 levels) •3 x 2 = 6 groups of subjects needed •Group 1: Runners on a Low fat diet •Group 2: Runners on a Normal diet •Group 3: Walkers on a Low fat diet •Group 4: Walkers on a Normal diet •Group 5: No exercise on Low fat diet •Group 6: No exercise on a Normal diet

Non-Experimental Design

Key Uses of non-experimental study designs: a. Describes co-occurrence of events b. Generate hypotheses c. Compare two methods or tests d. Predictions (once a relationship is established between two variables, one can predict variable 'Y' if given value of variable 'X')

Matching

Matches subjects by specific characteristics across groups. •Ensures each experimental / control group consists of subjects with same characteristics. All characteristics represented in each group. •Matched pairs design/analysis: Matching participants in pairs, randomly assign to control or exp. group •Characteristic determined/measured by researcher •E.g.: Based on test scores, measured BMI.

Quota

NON-PROBABILITY SAMPLING (non-random) Pre-planned number of subjects in specified categories (e.g., 100 male, 100 female) Selecting subjects until number needed is met. Similar to Convenience sampling, BUT if you cannot get enough people in a quota where you are, then you should go and find them elsewhere. Stratified Random vs. Quota Sampling: - In Stratified Random sampling, selection of subjects, from groups they are divided into, is random. - In Quota sampling, interviewer selects first available subject who meets criteria: is a convenience sample --> NOT RANDOM!

Purposive

NON-PROBABILITY SAMPLING (non-random) Similar to convenience sampling, BUT people should meet some predetermined criteria (age, weight, health condition, etc.).

Snowball

NON-PROBABILITY SAMPLING (non-random) Similar to purposive sampling, BUT it is very difficult to locate and recruit participants due to condition under study (e.g., a rare disease or health condition, etc.)

Convenience

NON-PROBABILITY SAMPLING (non-random) Subjects are selected because it is easy to access them. Could be called a "take-them-where-you-find-them" method of obtaining participants. Therefore, it is not random, because not everyone has an equal probability to be in that sample.

National Research Act of 1974

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research •Identified principles of research conduct and ways to ensure those principles were followed •Regulations passed: required researchers to get voluntary informed consent from all persons taking part in studies conducted by Department of Health, Education, and Welfare. •All protocols must be reviewed by IRB. •Formed Ethics Advisory Board •Efforts to promote highest ethical standards still worked on today: •E.g.: National Bioethics Advisory Commission, Presidential Commission for the Study of Bioethical Issues •Created the Belmont Report

Purpose of a Research Proposal

Once a researcher has identified topic of interest, conducted a thorough review of literature, formulated research question to be tested written proposal is created and submitted to potential funding sources/grant applications Proposals: •Represent investigator's understanding and capability of conducting proposed research to answer question of interest •Demonstrate appropriateness and rationale of study methods •Serve as a guide for data collection •Seek permission of IRB •GET FUNDING!

simple random

PROBABILITY SAMPLING (random) Every member of population has equal probability of being selected for sample. Procedure: Names drawn out of a hat or from a randomly generated list of numbers.

stratified random

PROBABILITY SAMPLING (random) Population divided into subgroups (or strata), and random sampling techniques are then used to select sample members from each stratum. Procedure: Divide accessible population into groups that differ in important ways (e.g., age groups, gender, etc.); then select random samples from within each group.

Cluster(Multistage)

PROBABILITY SAMPLING (random) Rather than randomly sampling from a list of individuals, researcher can identify "clusters" of individuals and then sample from these clusters A multi-stage selection process. Used when accessible population is too large. Procedure: Population is divided into groups (e.g., geographic, organizational, etc.); then some groups are randomly chosen. Then you can choose all or randomly sample from those chosen clusters.

Disproportionate

PROBABILITY SAMPLING (random) Special case of Stratified Random Sampling Used when proportions of population and sample are not equal but you are interested in looking at data as if equal proportions on some characteristic did exist.

Review: Types of Sampling

Probability Sampling: •Simple Random Sampling (equal probability) •Stratified Random Sampling (subgroups or strata, equal) •Disproportionate Sampling (subgroups or strata, unequal) •Cluster Sampling (large & dispersed populations multistage) Non-probability Sampling: •Convenience Sampling (based on availability) •Quota Sampling (stratification & proportions) •Purposive Sampling (recruitment based on inclusion & exclusion criteria) •Snowball Sampling (hard to locate individuals)

Differences Between Proposals and Scientific Publications

Proposal 1. Abstract 2. Introduction 3. Lit Review 4. Objectives/Hypotheses 5. Methods 6. Discussion: predictions, strengths/limitations, significance, potential application, future directions Scientific Publication 1. Abstract 2. Introduction/includes lit review type of info., incorporates hypotheses 3. Methods (sometimes found last) 4. Results 5. Discussion: interpretation of results, strengths/limitations, significance, future directions

Blocking

Reducing intersubject differences: Prevents unintended effects on DV • Blocking: grouping participants by an attribute- such as age. • Incorporates attribute as a variable into design thru grouping •Acts as second independent variable (you can compare differences in your DV between groups). Each group is different based on this characteristic. • E.g. 30-39, 40-49, 50-59: each age category is a block (group)

Review and modifications to ethical standards and regulations are essential!

Regulations, review processes, modifications to 'ethics' and what constitutes ethical violations are continuously modified and evaluated to stay current and meet needs of 'today's research'

The 'Takeaway': Specifics are Important!

Research questions need to be measurable and address specific outcomes. •For example: If outcome is 'health' •Questions to consider: •What is/are characteristic(s) of health that will be addressed/measured? •Health can be interpreted as a number of different factors/components, it is important to be specific. •Are outcomes appropriate for our population of interest?

Reporting of Results

Sharing knowledge stems new ideas, collaborations, promotes progress! •Scientific conferences: present your study results to your colleagues •PUBLISH, PUBLISH, PUBLISH! •Submit to peer reviewed journals •Impact factors: a way of 'ranking' •Reviewing process: •Reviewer's (experts in field) make comments/suggestions •You make edits (sometimes requires additional trials or analyses) and reply •(Hopefully) accepted for publication

The Belmont Report: Ethical Principles

Three Primary areas: •Respect for Persons: Autonomy-informed consent •Beneficence: Maximize benefits; minimize harm (assessing risks vs. benefits) •Justice: Selection/distribution of subjects, risk/benefit to specific subjects, fair treatment, communication of research •1991: Federal Policy for the Protection of Human Subjects •IRB Common Rule •Regulations for additional protections for pregnant women, human fetuses, neonates, prisoners, and children

Secondary Sources

summarizes, interprets, or provides commentary on information obtained from primary sources May summarize many studies in field to give an overview of what is known on different aspects/components of the topic (review paper). •Systematic reviews: usually summarize clinical studies to provide evidence for a point or question they have or to show effectiveness of treatments. May be seeking an answer to a question/hypothesis but are using other researcher's studies/data to provide a collective answer. This type of study will likely have a methods section but does not have their own participants. •Meta analyses utilizes data from many studies to conduct further statistical analysis. By doing this they are able to increase statistical power as they now have data from many more subjects. They will frequently identify 'common effect' of what is being tested across multiple studies. This type of study will likely have a methods section but does not have their own participants. •**Secondary sources also include reputable websites (.org, .gov., .edu)

Next: Formulate a Hypothesis

•"... a tentative idea or question that is waiting for evidence to support or refute it" •Reasonable/Educated "Guess": a prediction that can be tested •Educated Conjecture (an opinion or conclusion formed on basis of incomplete information) •Statement asserting what you believe is true in a particular situation •Should be as detailed as your question!! •Statement asserting that 2 or more variables are related to or have an effect on one another

Limitations of Non-Exp. Research

•'Cause & Effect' is not determined •Other Factors Likely Involved (Third-Variable Problem) •Example: A study assesses relationship between sodium intake and blood pressure. Consider other factors not accounted for in study that likely impact blood pressure (third variable problem!) Sodium ⬄ Blood Pressure (sedentary lifestyle, overweight)

Custom and Tradition

•Accepting something because people have always known it to be true. •Can be 'good' for societies/communities but is 'bad' in clinical science: •Example: In clinical science, we don't want to say, well, we've always treated cancer 'X' a certain way, why not just continue? •If we relied on what we've always known, no new discovery would take place. •Maybe there are other, more effective alternatives for treating the disease? Perhaps these alternative treatments have fewer side effects and improve life expectancy.

Factorial Designs

•Allow you to assess 'main effects' and 'interaction effects' •Main Effects: Average (mean) effect of each IV on the DV •Effect of exercise (alone) •Effect of diet (alone) •Overall main effect determines whether either variable had an effect •Interaction Effects: Combined effects •Effect of running combined with low fat diet (different levels) •Determines whether one of the IVs only has an effect because of interaction it has with other IV. •i.e. Combination/ interaction of IVs resulted in the effect •Measurements are plotted to see if the lines touch or cross

Authority

•Because a leader said it, it must be true... •Not the case. Think: politicians, news sources •Important to learn in college: always question things, including authority! •Be skeptical of what you read and hear from so-called authorities. •Consider your source! •Less reliable: non-scholarly internet sites, news media •More reliable: original sources (read them yourself!), peer-reviewed articles, textbooks •If you can, read primary sources of information (i.e. original research/documents) to determine whether it is IN FACT true •Example: Saturated Fat •Heart disease epidemic - heart disease became #1 cause of death •Knew high cholesterol was linked to increased risk for heart disease. •Researchers learned eating saturated fat seemed to increase levels of cholesterol in blood. •Assumptions were made: •If fat raises cholesterol and cholesterol causes heart disease, then that must mean saturated fat causes heart disease ('diet-heart hypothesis') •Diet-heart hypothesis became public policy in 1977 •None of these assumptions were based on experimental evidence in humans •Many studies have since shown that while saturated fats increase cholesterol, they increase HDL levels and 'large' LDL levels (LDL that doesn't impact heart disease- doesn't easily penetrate blood vessel walls)

Ensuring Responsible Conduct and Compliance in Research

•CITI Training •All researchers including students and key personnel, such as study coordinators or individuals obtaining consent must complete online course for protection of human participants in research BEFORE IRB will approve a study. •Renew training every 1-3 years •Environmental Health & Safety Trainings •SCRO: Stem Cell Research Oversight Committee Continued training and monitoring is important!

Sampling Bias

•Certain attributes of a sample that are not representative of population (impacts the results!) •Can be conscious or unconscious •Leads to Sampling Error Deviation of sample from population. •Example: Exercise and Bone Mass --> Sampling 30-60 y/o •Could introduce bias...Why? Consider what is being tested...

Intuition

•Characteristics: •Gut feelings, basic non-scientific observation, common sense •Accept information without question or skepticism •It can also involve making causal connections between two events that are unrelated Example: A couple who is having difficulty getting pregnant adopts a child. A few months later, they get pregnant. The faulty conclusion is often made that adoption caused pregnancy, perhaps due to reduced stress / pressure to become pregnant. Just because two things occur close in time does not mean they are related. •Limitations: •Uses feelings to assume fact, without evidence/proof •Does not take into consideration other factors that may explain behavior •Assumes cause and effect when there is no link/association

Title

•Concise, but include variables of interest •Includes important keywords Examples: 1) Predicting HIV Disease Progression Using a New Measure of Medication Adherence 2) Impact of a protein supplement on bone mass in older women 3) Calcitonin for Treating X-linked Hypophosphatemia 4) Collecting and Analyzing Tissue Samples From Patients Undergoing Surgery for Non-Small Cell Lung Cancer

Experimental Research

•Conducted to determine effect of a treatment, procedure, or program that is intentionally introduced (manipulated by researcher) and result/outcome is measured Key Characteristics: •Something is purposely changed/ implemented/ manipulated by researcher •Control(s) (parameters) used to prevent unwanted factors from influencing study outcomes When there is manipulation and control within study, makes us more confident that manipulation/ change made by researcher caused observed effect/ outcome

If a study includes the use of deception, the investigator must provide:

•Confirmation that study design meets criteria for waiver of consent •Description, explanation/justification for deception •Indication of whether deception may affect a subject's willingness to participate •Description of post-study debriefing that includes offering participant option to withdraw their data from study •Requests for exception of debriefing is subject to full board review •Description of any previously used deception in similar studies •Alternatives to deception that were considered

Non-compliance with Ethical/Federal Regulations

•Consequences: •Audits/Site Visits •Citations •Corrective action plans and monitoring •Shutting down all research activity (stop funding)

Types of Research Questions: Different approaches - different types of information gained

•Descriptive •What beverages do college students consume daily? •Correlational •What is relationship between daily hours of studying and daily alcohol consumption? •Experimental •Does a low carbohydrate diet compared to a low fat diet result in greater weight loss among college students?

Descriptive Research

•Designed to depict participants in an accurate way/answer an open ended question. •Information is collected without changing environment or conditions (i.e., nothing is manipulated or implemented by researcher) = Non-Experimental •Typically observational in nature •Example topics: •A political candidate wants to know how people view him/her by conducting a survey •A clinical psychologist wants to determine whether there is a need for a mental health program in a given community by assessing frequency of mental health-related incidents within past 5 years

Why research matters and the importance of communicating scientific findings

•Develop innovative, more effective treatments •Improve clinical practice •Discover & validate scientific concepts •Determine efficacy of new treatments to inform clinical guidelines •Determine efficacy of new drugs for FDA approval •Influences legislation •Aids in program development

Why sampling?

•Economical: Keep in mind you will be working within a budget (grant funding) •Time Efficient: Your funding is only granted for a certain amount of time. •Potentially More Accurate/Generalizable: You can ensure you select a sample that is truly representative of greater population Goal of Study - Generalization of Results (generalizability) to greater population Goal of Sampling - Represent the Population

Purpose Statement

•Explain rationale for your study •One sentence written in future tense (typically a statement version of your research question).

Confounding variables

•Extraneous variables that were not controlled for and could impact your data collection/results! •Example: Effects of acupuncture on shoulder pain & subjects on pain medication (confounding variable) •Would be difficult to determine effect of acupuncture on shoulder pain if participants were also taking pain medications! This should be controlled for by not allowing participants to take medications! •Experiments are designed to control for confounding variables

Extraneous variables

•Factors/variables that could impact your study & results (a.k.a. potential confounds) •Extrinsic factors: related to environment or experimental situation •Intrinsic factors: changes in personal characteristics of participants, units measured, tools used to take measurements (internal study factors)

Understanding Research Methods

•Important for Professional Reasons •Healthcare professionals give patients recommendations and interact with public 1.Advice/ recommendations should be evidence-based (research-based) 2.Recommendations are based on 'good science' •Not all science is good science despite best efforts with peer- review •Depends on research methods: directly impacts reliability of results •New data vs. old data: staying current in your field, developing your professional opinion. •Changing and developing/advancing knowledge, evidence, and technology •Retracted studies •More generally: provides you with problem solving/logical skills

How to Control for Confounds

•Inclusion and Exclusion Criteria to eliminate them (sampling method) •Random Assignment (assign subjects to different groups randomly) •Control Group •Control Environment (temp., light, etc.) •Equivalent Subjects (shoes, clothes, etc.) •Minimize impact of researcher staff (only one or two researchers) •Train and Monitor data collectors (e.g., using an equipment) •Same Equipment (Use same weight scale throughout project) •Control Subjects' Activities (ask about things that may affect data) •Reduce Observational Bias (Blinding: single & double blind)

Steps in Research Process: Forming a specific idea

•Initiate an idea - Initial review of literature E.g.: Smoking & Health Consequences •What are some of the current health consequences of interest? •Use of Review Papers that discuss results of numerous studies •Select a more specific idea E.g.: Smoking & Number of Sick Days Among College Students •What area of this topic needs further study/information (i.e. what is the gap in information/need for further study)? •E.g.: your initial review showed that number of sick days related to smoking had been well studied in middle-aged working adults, however it had not been addressed in college students •Review literature (in depth) •Once you formed your research topic and formulated question, review/read primary studies on topics related to yours (e.g. smoking and sick days in adults, smoking frequency in college students or young adults, frequency of illness in college students).

Ways of assuming knowledge that lead to bias and false assumptions

•Many people rely on non-scientific, flawed "ways of knowing", that lead to biases and faulty conclusions (instead of scientific research): •false consensus effect •Custom and tradition •Intuition •Authority •Pseudoscience

Quasi-Experimental Design

•May lack one or more of the following: •True control group •Unequal groups •Randomization

Members of the IRB

•May vary depending on organization: Academic, Institutional or Government •UConn IRB Members: •Chair, Vice-Chair, Faculty with varying expertise in Social-Behavioral and Bio-Medical research •Community members, one non-scientific member •May require prisoner advocate •May require professional who has expertise with children •Graduate Students

Epidemiological Research

•Non-experimental (usually) •Large databases of population information may be used (e.g. census) •Study of health and disease in population •Incidence of disease •Risk factors for disease •Predicts the probability of disease •Factors that may prevent diseases

Pseudoscience

•Phrenology (Greek: phrēn, "mind"; and logos, "knowledge"): •Claims to be able to determine character, personality traits & criminality based on shape of head •Franz Joseph Gall, around 1800 •Used to justify racism. •Lack of evidence to support claim!

What Makes a 'Good' Research Question?

•Poor Scientific Question (vague): 1. Is exercise healthy? •Does not specify what they mean by 'exercise', or how they are defining 'healthy', nor does it indicate how/what would be measured or population/participants it would include. 2. Does yoga affect stress? •Does not specify frequency or duration yoga would be performed, nor does it indicate how stress would be measured •Good Scientific Question (specific): 1. Can brisk walking 3x per week for 6 months reduce CVD risk in overweight adults ages 35-45 y.o.? •Specifies type of exercise, frequency, duration, measure of health (CVD risk factors) and population/participants. 2. Can 30 minutes of yoga per day reduce reported levels of stress in adult male lawyers ages 35-45 y.o.? •Specifies type of exercise, frequency, duration, measure of health (self-reported stress levels, i.e. survey data) and population/participants.

Predictions & Discussion (future tense)

•Predictions •What outcomes do you expect? Why? •Mirrors Introduction/Lit. Review Section •Discussion •Generalizability of findings - sample population, animal models •Variables not controlled •Other study limitations/strengths •How were weaknesses addressed? •Significance, benefits, potential application of results/findings

Primary vs. Secondary Sources

•Primary Source: A report/article on original research that includes all details necessary to duplicate study (a complete methods section!). I t should include: descriptions of rationale of study, their participants/subjects, materials/items used for evaluation, procedure, results, and of course, references. •When identifying a source as primary or secondary: fastest way to do this (if it is not stated at top of article), is to look at methods section to determine if they sampled and obtained data from their own participants/ they collected their own data. If they did, this is a primary source!

Types of Sampling

•Probability Sampling: •Random Selection •Every unit has an equal chance of being chosen (not haphazard) •Sample should be free of any Sampling Error (it exists, due to chance) •Non-probability Sampling: •Non-Random methods •Probability of selection is not known •Sampling Error cannot be estimated •Common in Clinical Research (Certain condition or intervention)`

Introduction (past tense)

•Provides brief description of overall problem, population affected, current treatments/standard of practice (if any). •Cites recent key studies, using reputable sources (e.g. studies from peer reviewed journals) •Give statistics, facts (not just internet sources) •Discuss if studies to date conflict, or if there is a lack of research in this area •Concludes by indicating NEED for further study

Literature Review (past tense)

•Provides foundation for research question •Presents recent studies on related/similar topics to provide a rationale for your proposed study. •Do studies agree/disagree? •Compares and contrasts studies within each subtopic/section •What's next? •Use subheadings to divide literature review by subtopic •Final paragraph (conclusion) of literature review - what does review mean (i.e. summation of what is currently known, and where there is still a lack of knowledge)? •Use recent primary references (as opposed to secondary) •APA format (depends on agency/journal): refer to each study by author and year •Overall purpose of Lit. Review: Shows reader your proposed study is a logical 'next' step

Quota vs Purposive Sampling

•Purposive: Sampling based on not only inclusion (~qualifying) criteria, but also exclusion criteria (aside from those opposite of the inclusion criteria). •Criteria are dependent on what needs to be assessed in study, and aspects that may interfere with data collection/results of study (i.e. confounds).

Quota vs Stratified Random or Disproportionate Sampling

•Quota: Sampling based on a few qualifying criteria, more specific, meeting needs of study and not concerned with proportions represented in larger population.

References & Appendices

•References: •Alphabetical Order •Articles/Books/Dissertations/Reviews •Use appropriate format: many behavioral sciences use APA Format •**Depends on field of study/granting agency •Surveys, Questionnaires, Other Tools •Develop your own OR reference them •Informed Consent •8th grade reading level •Note: this will be further discussed in 'Research Ethics' lecture •Timetable

logical reasoning process used in research: inductive

▪Use specific clinical observations to make general explanations / conclusions Example: ▪Specific observations: On several occasions, a nurse in a pediatric unit observes that when a hospitalized child's parents leave room, child becomes anxious. ▪Pattern: nurse observed this on several occasions, so there appears to be a plausible pattern. ▪General explanation: Infer all children experience anxiety when separated from parents. ▪Problem: Susceptible to all biases we just discussed. That is, there is a leap from observation to generalizations which could be biased by intuition, etc. Thus, while specific observations may be true, generalization may not be true.

IACUC: Institutional Animal Care and Use Committee

•Responsible for reviewing humane care and use of animals in research and teaching. •Subject to federal laws: •Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS1986) •USDA Animal Welfare Act/Regulations (CFR 1985) •Many clinical trials using human subjects started in cell cultures (in vitro) and/or animal models (ex vivo, in vivo) •Many animals have been involved in research, but mice are most commonly used due to ability to create genetically modified mice Reviews scientific proposals to ensure: •Minimal number of animals to still ensure statistical power are being used •Many animal studies will include as few as ~ 3-5 per group and/or may include fewer animals in 'control' group •Any procedures/tests that could gain the same information/scientific benefit from cell cultures or computer simulation (in silico) are performed as such. •Discomfort/pain/risk to animals is minimized through humane treatment. •Risk-benefit evaluation •Safe practices for animal and researcher •Researchers must complete IACUC trainings

Ethical Abuses - Tuskegee Syphilis Study

•Started in 1932: Public Health Service & Tuskegee Institute: Study natural history of syphilis in black males •Initially involved 600 men; 399 w/syphilis, 201 without •Men were told they were being treated for 'bad blood', a term used to describe several ailments, weren't given choice to not participate •Never actually received proper treatment, even when penicillin became drug of choice for syphilis in 1947 •Intended to last 6 months, continued for 40 years (until 1972)! •News story led to public outcry and formation of an advisory panel •National Research Act of 1974 was then developed

Informed Consent

•Stems from ethical principle: Respect for Persons •More than signing a form, may be ongoing •Especially important for longitudinal studies, studies that involved deception, and studies involving greater than minimal risk •Required Elements: •Clear indication that this is 'research' •Explanations of purpose, subject's participation, procedures to be followed, which procedures are experimental. •Potential risks and benefits •Disclosure of alternative procedures or courses of treatment that might be advantageous to the subject •Explanation of procedure to maintain confidentiality •Compensation •Who to contact with questions or in the event of research related injury etc. •A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which subject is otherwise entitled. •May discontinue participation at any time •Circumstances that may result in termination of subject's participation •A statement that significant new findings developed during course of research, which may relate to subject's willingness to continue participation, will be provided/revealed.

Reduce inter-subject differences

•Strategies: 1. Select Homogeneous Subjects: select those who have same characteristics of extraneous variable(s) 2. Blocking: group subjects according to a 'blocking variable' (e.g. age groups, grade levels) 3. Matching: match subjects on specific characteristics into groups (each group contains participants with each characteristic) 4. Subjects as their own control: expose all subjects to all levels/conditions of IV (repeated measures) 5. Statistical Techniques: adjusting scores statistically for an extraneous variable (Analysis of covariance)

Stratified Random vs Disproportionate Sampling

•Stratified: sampling from equal groups and/or sampling equally/proportionately from groups •Disproportionate: sampling equally from unequal groups or sampling

Scientific Method

•Systematic: sense of order and structure •identifying problem, collect evidence/data, analyze data, interpret findings •Empiricism: knowledge must be based on scientific observation (not anecdotal) •Control: design study to limit effect of extraneous (unwanted) factors/variables in your research study •Falsifiability: research conducted may provide support or fail to provide support of an idea/hypothesis: either outcome is accepted •Peer-review: prevents poor quality research from becoming part of scientific literature. Before results of a study can be published in a scientific journal, experts in field will review study methods & results, then provide feedback to editor who makes final decision whether to publish

Methods (future tense)

•TWO Purposes: Express ability and provide details to enable replication (Reproducibility) •Divided into subsections: 1. Design •Correlational, Experimental, etc. •Variables, Groups •Includes IRB approval will be obtained 2. Participants •Sampling technique, inclusion and exclusion criteria, sample size, how you will recruit them, how you plan to control for dropouts (enroll more subjects than needed), compensation •End with all subjects will sign Informed Consent form 4. Instruments 5. Procedures (includes timeline for entire study) 6. Data Analysis •Linked with objectives/hypotheses •Statistics to be used must match hypotheses •Statistical Programs (MS-Excel, SPSS, SAS, etc.) •Procedures for analyzing collected data

False Consensus Effect

•Tendency of people to overestimate the level to which other people share their beliefs, attitudes, and behaviors. •We often believe that others are more like ourselves than they really are. •Our predictions about others' beliefs or behaviors, based on casual observation, are very likely to err in direction of our own beliefs or behavior.

Experimental Research Designs

•True-Experimental •Pre-test / Post-test •Post-test Only •Factorial Design •Quasi-Experimental: •Within-Subject (Repeated Measures) •Crossover •One group Pre-test/Post-test, Post-test Only

Research influences legislation

•U.S. Supreme Court Decision, 2005 •Supreme Court decided that juveniles could not face death penalty •This was based on neurological and behavioral research showing that brain, social and character differences between adults and juveniles make juveniles less at fault than adults for same crimes

Name & Title of Investigators

•Use full names with abbreviations for titles •Principal Investigators (PIs) and Project Directors •Full name of institution(s) (affiliations) •Example: University of Connecticut, Department of Allied Health Sciences, Storrs, CT University of Connecticut Health Center, Farmington, CT

Correlational Research

•Used to determine whether a relationship/association exists between two variables •Determines likelihood that when a change is observed in variable 'A', a change will also be observed in variable 'B'. •Non-Experimental •Example: What is relationship between hours spent studying and midterm grades?

When considering research...

•What do you find interesting? What excites you? •Smoking cessation? Depression? CVD? Diabetes? Obesity? HIV? •What is the current research gap in your area of interest? •Need to do a literature search to figure this out! •Where is there a gap/need for more information / additional research? •Example: someone interested in HIV would have to ask themselves, what stage is HIV literature at (what is currently known in field)? •Exploration: Is HIV a mysterious, unknown illness? •Description: What does HIV "look" like? How does it affect body? Who does it impact? •Prediction: What predicts HIV status? Risky sexual behavior, needle sharing predicts HIV viral load •Explanation: The better we are able to predict, the more we are able to explain what causes something. •Action: Treatments such as an HIV vaccine? Or, behavioral interventions to reduce HIV risk? •Is this a controversial area (i.e. is there disagreement in field?) •Current funding 'climate' in this area of research (opportunities for funding)?

Non-Probability Sampling

•When probability sampling is not feasible or applicable •Each person does not have an equal chance of being selected •Results can be criticized (limited generalizability) 1. Convenience Sampling (Haphazard) - Participants selected based on availability/ accessibility to researcher 2. Quota Sampling (Subgroups {based on defined characteristic} & Proportions) - Participants selected based on what is needed (50 diabetic and 50 non-diabetic participants to represent proportion of diabetics in target population) 3. Purposive Sampling (Recruitment based on Specific Criteria) - Participants must meet all inclusion and exclusion criteria to participate 4. Snowball Sampling (Hard to locate/rare individuals/criteria) - Once a few participants have been identified, they can help locate others (e.g. they may have met others with same condition)

Abstract

•Written Last! •Summary of project (~ 120-300 words) •Introduction to problem •What is known/not known •Purpose & objectives •Methods •Expected results •Predictions of results if study were funded and conducted. •NO References

What's next?

•proposal was a success: you obtained approval and grant $$ to conduct your research! (actually hard to achieve) •Any feedback/suggestions made by the reviewers were accounted for (you made any necessary changes to your proposed study design) •You conduct your study as indicated in proposal •What if you need to modify your procedure during study? •Any changes or adjustments that need to be made must be re-reviewed with the IRB if it involves changes with participants. •Data was collected and analyzed... now report your findings...

Major categories of research: Applied

▪Addresses real life problems / issues by offering potential solutions ▪Puts scientific knowledge into action ▪That is, uses knowledge gained in basic research to address real world problems. ▪Example: Will yoga help UConn students quit smoking? ▪Involves program evaluation (e.g., Is a yoga program effective at helping UConn students quit smoking?) Applied research builds on the knowledge gained from basic research!

Logical Reasoning Two types: inductive & deductive

▪Both types of reasoning are used in science to develop hypotheses. ▪That is, there is a constant interplay between inductive inference (based on clinical observation) and deductive inference (based on theory and experimentation). ▪Inductive inference is oftentimes used to inform and develop deductive, theory-based hypotheses, which can then be tested using scientific experiments. Inductive --> deductive ▪These ultimate results from deductive, scientific experiments (i.e., data) are considered scientifically rigorous and published in well-respected peer reviewed journals. So, ultimate deductive experiment moves science forward (not initial inference). ▪With this constant interplay, we get closer and closer to truth/answer

Major categories of research: Basic

▪Describes and examines nature of a behavior, e.g. social behavior ▪Basic research is conducted for sake of increasing knowledge. That is, the ultimate end-game in basic research is to increase knowledge ▪Example: What percentage of UConn students smoke?

Topic: Reducing fast food consumption in college students

▪Descriptive: On average, how many times per week do UConn students eat at a fast-food restaurant? ▪Correlational: Is weekly fast-food consumption related to weekly frequency of aerobic exercise? ▪Experimental: Does running 3x per week for 6 months effect fast food consumption? ▪Hypothesis: Among students who eat fast food at least 5x per week, we hypothesize that, compared to those who do not participate in a running program (control group), students who participate in running program (experimental group) will have a significant reduction in number of weekly fast food meals -IV: Exercise (running)/ No Exercise -DV: Number of fast-food meals consumed weekly

Research aids program development

▪Research on healthy eating, physical activity, and weight loss has informed development of: ▪Community-based programs: weight loss programs, disease risk/management ▪Worksite wellness interventions ▪University-wide healthy eating and physical activity programs ▪As a result, research has substantial public health impact. ▪Evidence-based interventions that are disseminated to large groups of people (communities, universities, worksites) help large numbers of people eat healthy, exercise, and lose weight, all which impact important health outcomes such as cardiovascular disease risk factors

logical reasoning process used in research: deductive

▪Use general explanations (theory) to inform specific hypotheses/predictions Example: ▪Theory: Separation anxiety theory suggests that, when in stressful circumstances, children experience anxiety when separated from parents. ▪Specific hypothesis: If children are stressed, then they will have separation anxiety when separated from parent. ▪Observation: conduct an experiment and collect data to test hypothesis. Results of experiment can then support or provide evidence against original theory ▪Strength: Experiments and resulting data provide scientific evidence (data) for/against a theory. Thus, we are able to get closer to true "knowing." •preferred method of scientific discovery

Research Process: What to Consider When Getting Started

▪begins with interest in a general topic(s) (e.g. stress and sleep)......and then gets specific ▪Gain knowledge and define research question (use PubMed to do a literature search) •Who is it affecting? E.g., Students during finals week? •Is there a relationship? E.g., Is stress linked to sleep in college students? •How many people do this? E.g., What percentage of college students suffer from short sleep due to stress during finals week? •When is this occurring? E.g., Only during finals or more regularly? •What causes this condition? E.g., Why exactly does stress impact sleep? ▪ What methods exist to answer my questions? Do new methods need to be developed? ▪ Is question relevant/important? That is, did someone already answer these questions / do this study? ▪If not, I can go forward and ask, is my question measurable? That is, are there ways to measure sleep, stress, etc.? Also, is this question ethical?